Surgical Patient Care

Surgical
Patient Care
Improving Safety,
Quality, and Value
Juan A. Sanchez
Paul Barach
Julie K. Johnson
Jeffrey P. Jacobs
Editors
123
Surgical Patient Care
Juan A. Sanchez • Paul Barach
Julie K. Johnson • Jeffrey P. Jacobs
Editors
Surgical Patient Care

Improving Safety, Quality, and Value
Editors
Juan A. Sanchez Paul Barach
Department of Surgery Clinical Professor
Ascension Saint Agnes Hospital Children’s Cardiomyopathy Foundation
Armstrong Institute for Patient Safety and Kyle John Rymiszewski Research
& Quality Scholar
Johns Hopkins University School of Children’s Hospital of Michigan, Wayne
Medicine State University School of Medicine
Baltimore, MD, USA Detroit, MI, USA
Julie K. Johnson Jeffrey P. Jacobs

Department of Surgery Division of Cardiovascular Surgery
Center for Healthcare Studies Johns Hopkins All Children’s Heart
Institute for Public Health and Medicine Institute
Feinberg School of Medicine Johns Hopkins All Children’s Hospital
Northwestern University Johns Hopkins University
Chicago, IL, USA Saint Petersburg, FL, USA
ISBN 978-3-319-44008-8 ISBN 978-3-319-44010-1 (eBook)

DOI 10.1007/978-3-319-44010-1
Library of Congress Control Number: 2016956252
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Foreword I
Sixteen years ago the Institute of Medicine reported that healthcare in the
United States was not as safe as it should be. The report indicated that as
many as a million people are injured each year and at least 44,000 people, and
perhaps as many as 98,000 people, die in hospitals each year as a result of
medical errors that could have been prevented.1 John James, in an article
published in 2013, estimated the true number of premature deaths associated
with preventable harm to patients at more than 400,000 per year.2 While there
is little information regarding the number of patients associated with surgical
complications, there are 51.43 million inpatient and 534 million outpatient
surgeries performed a year in the United States. One study conducted at a
university teaching hospital with a level 1 trauma designation revealed that
despite mortality rates that compared favorably with national benchmarks, a
prospective examination of surgical patients revealed complication rates that
were 2–4 times higher than those identified in an Institute of Medicine report.5
Almost half of these adverse events were judged contemporaneously by peers
to be due to provider error (avoidable). Errors in care contributed to 38 (30 %)
of 128 deaths. Recognition that provider error contributes significantly to
adverse events presents significant opportunities for improving patient out-
comes. In another study, researchers looked at hospitals enrolled in the
American College of Surgeons National Surgical Quality Improvement
Program. Out of 1500 general surgery patients, 11.3 % were readmitted to the
1
http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/1999/To-Err-is-
Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf
2
James, John A New Evidence-based Estimate of Patient Harms Associated with Hospital
Care, Journal of Patient Safety September 2013 vol 9 No 3 p 122 http://journals.lww.com/
journalpatientsafety/Abstract/2013/09000/A_New,_Evidence_based_Estimate_of_
Patient_Harms.2.aspx
3
National Hospital Discharge Survey: 2010 table, Procedures by selected patient character-
istics—Number by procedure category and age; http://www.cdc.gov/nchs/fastats/inpatient-
surgery.htm. Accessed May 27, 2016.
4
US Outpatient Surgery Passes Inpatient to 53 Million a Year; http://www.tampabay.com/
news/health/us-outpatient-surgery-passes-inpatient-to-53-million-a-year/1124313.
Accessed May 27, 2016
5
Healey MA, Shackford SR, Osler TM, Rogers FB, Burns E. Complications in surgical
patients, Arch Surg. 2002 May;137(5):611–7.
v
vi Foreword I
hospital within 30 days with postoperative complications. Of the readmis-

sions, 22.1 % were due to surgical infections.6
In all locations across this country where surgical intervention takes place,
despite the implementation of several specific interventions such as the use of
checklists, pre-op briefings, time-out procedures, and debriefings, significant
progress in keeping patients free from harm has not been made. It is reported
that 40 wrong patient, wrong site, wrong side, and wrong procedure surgeries
occur weekly in the United States.7,8
All practitioners approach their profession with the best of intentions.
They want to provide quality care to the patients who come to be healed or to
have their lives saved. The question to be answered is why, despite all these
efforts and billions of dollars, do these statistics continue to reflect a lack of
significant progress to create a safe surgical environment? Surgery is a very
complex environment and Atul Gawande, MD, MPH, captured the reality of
this by stating “In surgery, you couldn’t have people who are more special-
ized and you couldn’t have people who are better trained. And yet we see
unconscionable levels of death and disability that could be avoided.”9
The premise of this book is that delivering surgical care is complex, com-
plicated, and requires multidisciplinary collaboration. The editors of this
book have brought together an impressive group of multidisciplinary authors
representing a global perspective on safety, quality, and reliability across the
continuum of care for the surgical patient.
Healthcare reform has brought many changes to healthcare; the focus on
accountability for quality (value-based reimbursement) instead of volume has
had an impact on the outcomes of surgical care as viewed by providers, pay-
ers, patients, and their families. This shift cannot occur without a change in
the culture. The authors recognize that system-wide and deep human factors
training are fundamental to developing the teamwork and robust communica-
tions that are essential to create a high-reliability organization focused on
preventing harm to patients. The important connection between patient and
healthcare worker safety, often overlooked, is highlighted and included in the
review of the fundamental principles of the science of safety.
There are significant challenges to provide safe, high-quality, cost-efficient
care in the high technology environment of the operating room. This book helps
to demystify many of the perioperative never events, patient injuries, and proce-
dural errors that occur in the operating room through the use of evidence-based
information, guidelines, and examples of checklists and forms that will be valu-
able additions to the tool kits for developing high-reliability organizations.
6
http://www.fiercehealthcare.com/story/surgical-patients-bounce-back-post-op-
complications/2012-08-29
One in 10 Surgical Patienhttp://www.fiercehealthcare.com/story/surgical-patients-bounce-
back-post-op-complications/2012-08-29its Readmitted with Postop Complications
7
Project Detail: Wrong Site Surgery Project. Joint Commission Center for Transforming
Healthcare. http://www.centerfortransforminghealthcare.org/projectsdetail.aspx?Project = 3.
Accessed April 22, 2016.
8
Seiden, S., Barach, P. Wrong-side, wrong procedure, and wrong patient adverse events:
Are they preventable? Archives of Surgery, 2006;141:1–9.
9
Gawande AA. How do we heal medicine? (video) TED.com. Filmed March 2012. http://
www.ted.com/talks/atul_gawande_how_do_we_heal_medicine. Accessed May 15, 2016.
Foreword I vii
Healthcare is highly regulated by government agencies, insurers, and vol-

untary agencies. The editors have included an extensive review of the systems
that have been developed and are vital to maximizing patient and healthcare
worker safety; however, they also make the point that each individual practi-
tioners and the leadership of the facility have responsibility and accountabil-
ity to create a harm-free environment. While the systems are an excellent
adjunct to creating a safe environment, they must be scientifically based,
focused on outcomes of care, and make sense and meaning to the users. The
authors identify that a culture of safety must have the active support of the
C-suite and be valued as a top priority and be articulated at the highest level
of the organization including the Board of Directors.
The chapter on “Patients and Families as Coproducers of Safe Outcomes”
identifies the essential role that patients and families have in protecting them-
selves. The reluctance of patients and their advocates to ask questions of
healthcare providers is no longer acceptable. They must be invited and learn
to accept the responsibility to ask questions about their care, and to be very
vigilant about the proposed procedure being planned and to pay attention to
all details of their care. Appropriate questions to ask include, “what proce-
dures are in place to avoid: a wrong site surgery, medication errors, and surgi-
cal site infections?”
The future of surgical care and outcomes is directed by the shift to value-
based reimbursement. This requires that management and clinicians rely on data
in a new way, for example including process improvement projects, measuring
workflow, exploring new systems of delivery of care to the surgical patient, and
the use of registries to improve outcomes. Facilities have a plethora of robust
data that needs to be distilled to make the necessary connections to predictive
analytics. Predictive analytics systems are being used, for instance, to under-
stand which patients are at higher risk for hospital readmission, to reduce hospi-
tal stays after joint replacement, and to anticipate staffing needs which reduce
overtime10 and the relationship between culture and safety outcomes.
This book offers a unique perspective on care of the surgical patient as it
includes contributions from all members of the surgical team including
patients and other scientific disciplines with relevant and valuable applica-
tions for the healthcare field. Surgical Patient Care: Improving Safety, Quality
and Value reflects the goals of all the team members who care for surgical
patients and are focused on advancing on the journey to high reliability of
surgical intervention. This will only be accomplished by day to day recogni-
tion that concern for patient safety must be constant and woven into the val-
ues of the institution. This book is an outstanding resource and I highly
endorse it. It should be a required book in every operating room and hospital
C-suite around the world to assist the surgical team and the hospital l eadership
on their journey to improve safety, quality, and value for surgical patient care.
Linda Groah, MSN, RN
Executive Director and CEO of the Association
of periOperative Registered Nurses
10
Karyn Hede, Moneyball Mindset, H&HN April 2016 p 23
Foreword II
Over the last 40 years, many high-risk industries have made great progress in
managing the challenges of improving safety and reducing harmful events.
They have created the conditions through which errors are considered inevi-
table and provide opportunities to learn and improve; systems are built that
mitigate accidents and prevent them causing serious harm; there is an under-
standing that a human factors approach creates teams of employees trained in
nontechnical as well as their traditional technical and clinical skills. These
changes, and others, have delivered safer air travel, safer nuclear power
plants, and safer construction sites.
The majority of healthcare systems, and the hospitals and other organiza-
tions within them, have talked a good game but they have not embraced these
fundamental changes. The result is that, by 2016, researchers at Johns
Hopkins University were estimating that medical error-related deaths were
the third most common cause of death of Americans, only surpassed by can-
cer and cardiovascular disease.
There is clearly a need to establish much greater understanding, amongst
healthcare professionals, health system leaders, patients, and families, as to
how risks arise in healthcare. Through this will come a more widespread
commitment to change in the way that care is currently designed and deliv-
ered. Too often, patient safety has been an interest of academics and enthusi-
asts and not the mainstream providers of care.
Patient safety thinking and research has tended to become fragmented. It
has taken a number of directions over the last decade: studies have elucidated
the extent of harm to patients and sought to explain its causation; risk and
adverse events have been documented in various clinical specialities (e.g.,
anesthetics), in treatment areas (e.g., medication), in demographic groups
(e.g., neonates), or in settings (e.g., operating rooms); problems with an
established pattern of harm have been reconceptualized and studied in patient
safety terms (e.g., healthcare infection); technological and other solutions to
reduce risk have been evaluated.
Whilst the safety concepts and interventions from other disciplines have
been applied to medicine and healthcare, it is often difficult for students and
practitioners to find the theory, practical implications, evidence-based solu-
tions, and thought leadership in one place.
ix
x Foreword II
This book fills this gap admirably. Although ostensibly about surgery, it
deals with the key themes and concepts in patient safety, many of which are
applicable much more widely across medicine and healthcare. It will be a trusty
companion for surgeons but also those who wish to learn, those who are look-
ing for new research directions, those who aspire to lead, and those who need a
new source of inspiration to reignite their passion for patient safety.
Sir Liam Donaldson

World Health Organisation
Patient Safety Envoy
oreword III: What Pilots
F
Can Teach Hospitals and Healthcare
About Patient Safety
Qantas Flight QF32 proved to me the need for leadership and well-trained,
experienced teams. QF32 was a black swan event*, an unexpected, improba-
ble event that had significant outcomes. Engine number two exploded on my
Airbus A380 4 min after take-off from Singapore airport on the 4th of
November 2010. Five hundred pieces of shrapnel cut more than 650 wires,
damaged 21 of the 22 aircraft systems, starting a 4-hour crisis that challenged
the 25 crew and pilots. QF32’s repair was probably the longest and most
expensive in aviation history.
QF32’s resilience was a team win. Within 2 hours of the engine exploding,
about 1000 specialists had amassed to support us from many locations as we
made our approach to Changi airport in Singapore. The last passenger disem-
barked the aircraft after another 2 hours. There was no panic. There were no
injuries. Teams of experts saved the lives of 469 passengers and crew and
saved tens of thousands of family and friends from traumatic stress.
QF32 reinforced our passengers’ perspectives of aviation safety. (1) Our
passengers value the extra training that crews receive in value-added airlines.
The thousands of hours of deliberate practice pilots conduct in simulators
paid dividends. Everyone delivered excellence under pressure without panic.
For me, QF32 reinforced my values that leaders who set a caring culture and
build great teams achieve remarkable outcomes.
When we look deeper, QF32’s success is not due to me, the crew, or the
passengers. The foundation for QF32’s success lies in the special culture and
resilience systems that exist throughout most of the aviation industry.
Pilots and surgical clinicians manage risks and mitigate threats to prevent
death. Both of our industries face threats from technology, the environment,
resources, humanity, and change. When we analyze disasters, we find a same-
ness in the causes. Most aircraft crashes, like the majority of adverse events
in healthcare, are the result of failures in resilience, particularly human errors
in communication, leadership, and decision-making.
The collision of two Boeing 747 jumbo jets at Tenerife in the Canary
Islands in 1977 is the world’s worst aviation accident. Five hundred and
eighty three people perished in this preventable accident, making it also the
*
black swan event - a completely unexpected event with significant impact that is usually
inappropriately rationalized because of hindsight bias (after: Taleb, Nassim Nicholas
(2010) [2007]. The Black Swan: the impact of the highly improbable (2nd ed.). London:
Penguin)
xi
xii Foreword III: What Pilots Can Teach Hospitals and Healthcare About Patient Safety
best example of human factors taking lives. At that time, the 747s had been
operating for less than 7 years and sales were booming. The 747 was the first
in a series of new generation, high capacity aircraft, so something had to be
done in this growing industry to ensure this accident never occurred again.
NASA convened a panel to address aviation safety and created the concept
called Cockpit Resource Management (CRM).
The Federal Aviation Administration (FAA) legislated that all military and
airline pilots receive CRM training. The aim of CRM was to teach crews to
improve their personal skills, communication, and how to build effective
teams that make better decisions. The idea of CRM was to make better lead-
ers who would build resilient teams. It was a challenge to convince autocratic
captains to defer to their subordinates. The captains who complained most
about CRM were the ones who needed CRM training the most.
The basic tenets of CRM are to avoid, trap, or mitigate the consequences
of errors resulting from poor decisions and unexpected failures. The steps
involve (i) Detect the problem; (ii) Access knowledge to understand the
implications and limitations; (iii) Prioritize events; (iv) Select the appropriate
action; and (v) Execute.
CRM deals with expecting and managing errors, not about preventing
errors. CRM starts with acknowledging our humility and accepting our vul-
nerabilities that we all make mistakes. Pilots are taught, to recognize human
limitations and the impact of fatigue. They identify threats and effectively
communicate problems, support and listen to team members, resolve con-
flicts, develop contingency plans, and use all available resources when mak-
ing decisions.
After proving a success in the cockpit, CRM expanded to include the
cabin crew. This CRM became known as Crew Resource Management.
Today CRM encompasses experts in all teams that aspire to a common goal.
CRM has never and will never be called “Captain Resource Management.”
CRM is about optimizing and amplifying team performance not the captain’s
performance.
CRM is the catalyst producing efficient teams in normal and emergency
situations. Crews have roles, tasks, and procedures for normal occasions.
CRM also provides the team environment and behaviors to solve problems
when the unthinkable black swan happens, and when checklists and standard
operating procedures (SOPs) are irrelevant.
We don’t know what the next black swan will be, where or when it will
strike. By definition our prepared defences will fail. Our survival depends on
enabling teams of experts to synthesize their knowledge and experience to
create novel solutions.
CRM is more than checklists. CRM has hooks into more than 40 human
and corporate factors. Human factors can be subclassed into five categories
(leadership, management, teamwork, skills, and personality). Corporate fac-
tors can be subclassed into six categories (governance, safety management
systems, safeguards, communications, and risk). Checklists provide a small
but important part of these frameworks.
Great leaders exhibit CRM skills. Pilots and physicians tend to be highly
skilled, technical, Type A personalities. We are confident and intensely strong
Foreword III: What Pilots Can Teach Hospitals and Healthcare About Patient Safety xiii
willed because these are the traits required to make life-and-death decisions
in seconds. These skills however do not make us resilient. Resilient leaders
also exhibit personal humility. They know teams are always more creative
than individuals. So great leaders channel their egos into the larger goal. They
genuinely understand empathy, teamwork, and deferring to expertise.
Teamwork multiplies the leader’s skills. That’s why great leaders enable
even greater teams. That’s why great leaders call success “team successes” and
claim failures as their own. Teams are reflections of their leaders and their
CRM skills. Whenever I am a passenger on an aircraft, it takes me just a few
seconds to sense the leaders’ culture—by observing the mood of the crew.
CRM is being infused into the medical industry. A growing number of
healthcare providers learn from aviation successes, accidents, and near
misses—more specifically, the safety systems in place in airlines that prevent
accidents reoccurring. In the last 5 years, several major hospitals have hired
professional pilots to train their critical care staff members on how to apply
aviation safety principles to medical work. For example: playing music dur-
ing operations that distracts others is the antithesis of CRM.
Though healthcare experts disagree on how to incorporate aviation-based
safety measures, few argue about the parallels between the two industries or
the value of borrowing the best practices from each other. CRM creates a
culture of pooling skills, listening, identifying threats, trusting and deferring
to experts, reducing risks, and correcting errors. CRM is ultimately about
saving lives.
Despite these important steps, healthcare remains dangerous to patients.
Governance is needed at the highest levels to install and audit similar systems
in medicine that have existed in aviation for decades. This includes creating
and harmonizing world standards for certification, training, safety, investiga-
tion, and reporting.
Qantas flight 32 proves it is possible to build expertise to survive a black
swan event. Mining, nuclear, and aviation industries operate successfully on
the premise that failure is never an option. Look inside these high-reliability
organizations and you’ll notice unique behaviors. These companies have a
chronic unease for the status quo, expect failure, do not simplify, and defer to
trained experts.
Aviation is a risk-laden but heavily regulated industry. Regulators set and
audit harmonized standards that are “written in blood”. Safety management
systems espouse corporate cultures that trust and defer to expertise. For the
individual passenger and their loved ones, our dedication to a lifetime of
learning and training gives those at the edge of chaos at the coalface the best
skills to survive the threats of technology, complexity, crisis, and change.
There are many keys to organizational resilience. Training for the known
knowns gives us a degree of personal resilience for the normal and perfect
storm events. Higher skills are required to survive black swan events.
Surviving black swans requires synthesizing all of our knowledge, training,
experience, teamwork, leadership, decision-making, threat and error manage-
ment, and crisis and stress management to handle events as a team that we
never explicitly trained for or expected.
xiv Foreword III: What Pilots Can Teach Hospitals and Healthcare About Patient Safety
These keys are useless without personal qualities, values, and a climate of
psychological safety. (2) Our values determine WHY we do the things we do.
It starts by taking 100 % responsibility and offering no excuses. My “WHY”
is ensuring every spouse or parent should expect their loved one home for
dinner after flying on my aircraft. Whatever happens at any stage in the pro-
cess—I am responsible. There are no limits. I will do everything possible to
ensure my passengers’ safety. Sheryl Sandberg, Facebook’s COO, says it
best: “Nothing at Facebook is someone else’s problem! When you see some-
thing that’s broken, go fix it.”
Neuroscience provides clues how on to motivate and empathize with oth-
ers and to lead effective teams. We are in a better space to remain mindful and
calm in emergencies, to influence and lead others when we understand the
science of how our mind works in crisis. I use this knowledge to calm pas-
sengers and reduce their dread of flying.
Doctors and pilots learn from each other’s professions even though a
chasm separates our safety performance at the individual, crew, and organi-
zation levels. Pilots of big jets might have the lives of up to half a thousand
passengers in their hands on any flight. In 2014, 641 people died in 3.3 billion
passenger flights. Looking from another perspective that’s 12 fatal aircraft
accidents in 38 million flights. If we accept the statistic that 400,000 people
that die unnecessary deaths in American hospitals every year, then the same
number (641 passengers) that died in 2014, die every 14 hours in American
hospitals.
I have had some experience with medical failures. My mother (1974) and
uncle (2009) died from unnecessary medical mistakes. My good friend Peter
was the unfortunate recipient of double wrong-sided eye surgery in 2015. In
Peter’s case the surgeon paused for 30 min after realizing the first mistake on
the first eye, before returning to make another mistake on the other eye. The
surgeon disclosed these errors days days later when Peter’s asked why his
vision had deteriorated. The mistake was reported to health authorities only
after Peter’s wider search for help.
“Aviation is safe” a doctor said recently, “because pilots are the first to the
scene of an accident.” I said, “If this is true, then patient safety might improve
if doctors die with their patients.”
Sometimes the safest decision before starting an operation is to STOP!
The pilots’ mantra is, “Safety before Schedule.” This means safety is our
number one priority. Everyone is not just empowered, but expected to STOP!
an operation they think is unsafe. In medical terms, this means every nurse is
expected to STOP! a surgery if the surgeon has not washed his hands. If the
doctor does not stop, then the nurse should contact the CEO and expect to be
backed up and not censured or demoted.
All great aviation, mining, and exploration companies have cultures that
demand employees to call STOP! For example, every employee at Arrow
Energy in Australia carries a card attached to their key ring giving them the
authority to call STOP! for any unsafe activity. Instructions include a mobile
number to call 24 hours a day if the operation is not stopped. The mobile
phone number belongs to the CEO. I have called STOP! many times during
my career. Calling STOP! is one reason why these high-risk industries are
Foreword III: What Pilots Can Teach Hospitals and Healthcare About Patient Safety xv
safe. So “Safety before schedule” really means “safety before rank,” “safety
before time,” “safety before secrecy,” and “safety before money.” “Safety
before schedule” is also the reason why I do not wear a watch.
Airlines use safety management systems (SMSs), training, and checking
systems to enhance resilience. SMSs define organizational structures, policies
and procedures. They include CRM, risk, fatigue, audits, reporting, investiga-
tions and crisis management.
Pilots must satisfy onerous training and checking requirements. I am
checked and recertified seven times every year. Physicians’ competencies are
rarely checked in most countries, after their initial certification. In some
countries like the UK and the USA, their knowledge (but not skills or atti-
tudes) is checked online (and alone) only once every 5 years. Good airlines
provide deliberate practice and immersive training to develop pilots’ skills
that exceed minimum standards. Deliberate practice enables skills to be
learned 30 % faster than normal training techniques.
“Surgical Patient Care” is fortunately a better path to resilience than put-
ting one’s life on the line and risk “being the first to the scene of an accident.”
Resilience is a learned skill requiring expertise, standards, and shared values.
Resilience requires a commitment to a lifetime of learning. No one is born
resilient and what got you here will not get you there.
Overconfidence breeds complacency, mediocrity, ignorance, and bias. The
saying is “Chefs are as good as their last meal” applies to aviation, because
“Pilots are only as good as their last landing”. There is no relief when aspiring
to resilience. I aim for excellence knowing I will never achieve it. I have a
chronic unease for the status quo. I know surviving one encounter provides
no insurance for the future. I am therefore dedicated to a lifetime of learn-
ing—a challenge that lies just as far ahead of me today as it did 40 years ago.
Resilience starts with a fierce will to excel. It also requires a sense of
humility and vulnerability and a chronic unease not just that accidents might
happen, but that they will. Richard Feynman said, “When playing Russian
Roulette, the fact that the first shot got off safely is little comfort for the next.”
Survival requires an obsession with process, quality, human factors, lead-
ership, and teamwork. It requires individuals to step up, stop a drift toward
failure, and stop the normalized deviance like the January/July Effect in hos-
pitals in which patients are endangered in a cycle that repeats itself every
year. (3) The January/July Effect is not new. Fresh but inexperienced medical
graduates turn up for work in hospitals. The avoidable death rate spikes in
hospitals when inexperienced graduates deliver medical care without suffi-
cient medical supervision. If this spike had appeared in aviation industry, then
the safety authorities would have analyzed the cause and made changes to
correct the problem, all within the first or second cycle. The January/July
Effect has continued, mostly unabated in the medical industry for over 25
years.
“Surgical Patient Care” is a must read for healthcare providers, adminis-
trators, and physicians who are serious about delivering safe and exceptional
service. World leading industry leaders share knowledge and experience to
improve safety. There are pearls of wisdom for regulators as well as safety
and investigation authorities. Corporate directors and executives should enjoy
xvi Foreword III: What Pilots Can Teach Hospitals and Healthcare About Patient Safety
the discussions of governance, culture, safety management systems, safe-

guards, and risk. Everyone will enjoy the insights to improve human perfor-
mance, target excellence, and achieve resilience.
I have known Doctor Paul Barach (one of the four editors of this book) for
many years. Our friendship has been a voyage of discovery. A world authority
on medical safety, Paul also understands where medical and aviation safety
intersects.
I extend my best wishes to you, the reader. That you are reading this book
means we share a passion for knowledge and aspire to expertise, personal
resilience, and the best customer care. “Surgical Patient Care” analyses the
same “elements of resilience” that exist in aviation. Just as aspiring pilots in
my profession must read “Handling the Big Jets” by D.P. Davies, “Surgical
Patient Care” should become a mandatory go-to reference for governments,
organizations, and clinicians who want to do better and deliver safe care for
every patient.
We don’t know if we will survive the next black swan event. We don’t
know when and where it will strike. When we commit to a life of learning,
gaining experience and leaderships skills, we’ll become intrepid leaders of
intrepid teams. At this point we will have the highest resilience and best able
to save lives.
Captain Richard Champion de Crespigny
Qantas Pilot in Command of Flight QF32 and Author
of the Award Winning Book “QF32”
References
de Crespigny, R. QF32, Macmillan Australia, 2012.
Edmonson, A. 1999. Psychological safety and Learning Behaviours in Work Teams,
Administrative Science Quarterly, 44(2), 350–83.
Vaughan D. The dark side of organizations: mistake, misconduct and disaster. Annu Rev
Sociol.
Culture: The Building Block for Successful
Partnering with Patients
At publication of this book, approximately 400,000 people will die every year
as a result of a serious safety event making medical errors the third most com-
mon cause of death in the United States. Some will dispute this figure arguing
that the data is not accurate and in fact much lower. Regardless of whether the
actual number is 100,000 or 400,000 dead considering that there is roughly
5000 acute care hospitals in the United States, 20–80 patients will die at each
facility because of a mistake—statistics we simply should not ignore. These
are patients—people—that are dying as a result of our errors, and while it
sounds shocking and perhaps a little embellished to use the term kill, we kill
these people.
The statistics should shock us but they don’t. As healthcare professionals,
we see a slow trickle of these errors as well as millions of others that don’t
result in death because they show up in reports one data point at a time as
nameless and faceless people. Our awareness and concern would turn to out-
rage if patients were killed in bulk and every time a mass killing occurred, we
saw a headline warning of the dangers of healthcare. It would not only raise
awareness to the problem, but would terrify us as providers for us or our loved
ones to be a patient.
The root causes of these errors are complex and multidimensional. People
are living longer, patients are sicker with an explosion of chronic disease and
worsening social determinants of illness, medical technology and innovation
is rapidly expanding and stressing our ability to keep up, and we struggle to
manage the increasing regulatory burden and other external influences that
make care delivery more sophisticated and at the same time more compli-
cated. All of this strains our systems and challenges our caregiver’s ability to
take care of patients. Our ability to pay attention to the “little things” that
cause problems becomes less, and the pressures on healthcare organizations,
leaders, and frontline caregivers to accommodate these pressures today are
unprecedented and worsening. Sadly, they create cynical, dejected, and burnt-
out clinicians.
Some would say that a loose definition of culture is “the way we do things
around here.” If this is true, then this textbook should be the operating manual
for every surgical department in the United States and around the world. The
chapters in this book represent a “how-to” approach to address many of the
issues we struggle with, and through clearly articulated strategy and process,
suggest ways to make the practice of surgery better and more broadly to help
transform healthcare overall. Executing on this body of work will make what
xvii
xviii Culture: The Building Block for Successful Partnering with Patients
we do more effective and efficient, and help us conquer our challenges with
the “little things” that lead to patient harm. But our efforts will not be com-
plete and we will not achieve high performance or reliability in our work
unless we begin to more prescriptively focus on the development of our
healthcare culture as well.
In healthcare, culture is a topic often championed by our leaders but it
typically remains a poorly defined and an invisible concept to our managers.
There is a tendency to recognize the mythical impact of culture on what we
do, but misunderstood as to how it can be leveraged by us every day to
improve our healthcare operations. Culture and organizational climate in
healthcare, unlike most industries, is a critical element that not only supports
what we do, but ultimately ensures our success in delivering high-quality and
reliable care to patients.
There are many different formal definitions of culture that encompass a
wide variety of adjectives. One definition that is particularly fitting for health-
care is articulated by the team at Forester Research: “A system of shared
values and behaviors that focus employee activity on improving the customer
experience.” If we substitute patients for customers and adopt our broader
definition of the patient experience as it relates to safety, quality, and service,
then this definition becomes more aligned with the work ahead of us and is
consistent with the results we are starting to see in applying this data.
The patient experience has typically been defined incorrectly as making
patients happy or improving patient satisfaction. Nothing could be farther
from the truth, and in fact, the patient experience is more closely aligned with
the mission of healthcare and the patient promise of delivering safe, high-
quality care, in an environment of patient centeredness than it is with purely
satisfaction. Medicare’s inpatient Hospital Consumer Assessment of
Healthcare Providers and Systems (HCAHPS) survey has nine questions
about how we communicate with patients, three questions each on nurse, phy-
sician, and medication communication. Certainly, if the survey was designed
to measure happiness, we would not need nine communication questions.
However, when nurses improve communication at the bedside, medication
errors, falls, and pressure ulcers are reduced—and those are safety consider-
ations. When physicians communicate more effectively with patients and
nurses, compliance with treatment and coordination of care improve respec-
tively—both quality issues. It is also true that patients are happy when we
communicate more effectively, but if we focus on the broader objective of
improving overall communication, we have touched safety, quality, and the
experience of care and thus improved not only each of those critical drivers,
but the effectiveness of care delivery and deliver better value as well.
The importance that culture plays in supporting this assertion is indisput-
able. Press Ganey has correlated its engagement database of over 1.8 million
caregivers against its HCAHPS database that includes 52 % of hospitals in the
United States. Organizations where employees and physicians are more
engaged and aligned around patient centricity have been shown to have higher
patient experience metrics. The same correlations can be seen with the Centers
for Medicare and Medicaid services value-based purchasing program (VBP):
high employee and physician engagement equates to better performance on
Culture: The Building Block for Successful Partnering with Patients xix
VBP, and while providers often detest linking what we do to improved finan-
cial performance, the reality is that financial performance improves as well.
There is a more important piece to this story beyond just experience and
financial metrics. As it turns out, similar relationships are seen in publicly
reported safety metrics. Evidence is increasing, as more studies are published
every year, linking higher performance on outcomes and experience of care
with improved clinical performance (1). In one of the best published studies to
date, a group examined data looking at 180,000 surgical patients from 102
hospitals comparing HCAHPS performance against surgical complications as
reported in the American College of Surgeons National Surgical Quality
Improvement Program (NSQIP) database. They found that in organizations
with higher performing patient experience, mortality and minor complications
were lower, and rescue rates from serious complications were higher (2).
Admittedly it would be a leap to suggest a causal association that improv-
ing patient experience leads to improved clinical outcomes; however, the cor-
relations are clear and when you look at the association more broadly, the
common foundation of improved performance is through caregiver engage-
ment, which speaks directly to our healthcare culture. When organizations
support a healthy workforce culture, where people are entering their organi-
zations thinking about the higher purpose of taking care of patients, engaged
in their work, free from harassment and bullying, trust their leaders and feel
valued, healthcare delivery on multiple fronts is better. To deliver on the
patient promise, achieve better operational performance and high reliability,
and improve healthcare overall, we must recognize the role that our culture
plays and the imperative to leverage this critical component of our organiza-
tions in our work. So, where do we start?
Cultural transformation starts by getting people to talk about it and
empower every leader to manage it. Our cultures are our people and people
are difficult to change, and that message is never accepted with open arms.
We are all familiar with Peter Drucker’s adage “culture eats strategy for
breakfast.” With this in mind, we must be thoughtful about how we discuss
and approach our work in order to transform or evolve our culture to meet the
requirements of the future.
The words we use are important. Imagine if a healthcare leader walks into
a room full of physicians and proclaims that we have to change our culture.
The message from that statement is that everything we are doing today is
somehow wrong and the inference is that there is a personal responsibility
for the organization’s problems. The tone is negative and there is a connota-
tion of blame and shame. When talking to healthcare professionals, whether
physicians, nurses, or others, vocabulary, language, and respect matter. The
conversation on cultural change needs to start with validating the work care-
givers do every day to take care of patients—that it is hard work and these
people are universally committed to doing a good job. Recognize them for
their achievements, and then ask them to help with your initiative to evolve
the culture to where it needs to be. Cultural transformation is the ultimate
team sport and we need our people to enthusiastically own their culture and
help transform it.
xx Culture: The Building Block for Successful Partnering with Patients
Just as we measure the voice of the patient to understand how we are

delivering care, we must measure the voice of our caregivers through engage-
ment to understand how well we are managing the organization. Just asking
employees what they think is not good enough and often our leaders and
managers have blind spots about how well they are managing people.
Organizations must understand how their people are feeling, thinking, and
behaving. Implementing employee, nurse, and physician engagement surveys
can provide valuable information that can be used to help identify opportuni-
ties for improvement.
We must work to level our cultures and message the “why we are in health-
care” to reenergize our shared sense of purpose. We talk about our people
being a group of highly functioning, cohesive professionals focused on the
task of keeping patients at the center of our work. The reality is that, through
decades of history, we have created tribes of different subcultures—physi-
cians, nurses, administrators, and others that do not function in a unified fash-
ion creating silos that don’t work well together. We must level the power
differentials and recognize that every role is necessary and no one is more
important than someone else. People are different and the competencies they
bring support different activities, but everyone is critical to the mission and
this demands mutual respect and humility. All people enter healthcare because
of a desire to help people; we are altruistic, compassionate, and empathetic.
However these characteristics are degraded by the “hamster wheel” of every-
day clinical operations and the hard work of taking care of patients. In health-
care, we are very efficient at calling out problems and blaming people for
errors. Accountability is critical to our work but it cannot come at the expense
of validating the importance and commitment of the work of our caregivers.
Our leaders and managers must be developed with critical competencies to
help them become better at their jobs. One example is high reliability.
Healthcare is an industry that requires us to function consistently and reliably,
similar to other high-reliability industries such as the airlines, nuclear power,
and the military. Mistakes in our industry have devastating consequences and
result in poor, inconsistent outcomes and death. Reliability is the probability
that a system, structure, component, process, or person will successfully per-
form the intended function(s). A critical component to achieving a high-
reliability operating system is how an organization develops trust among and
between its leaders and workers, and teaches their leaders and managers to
drive toward high reliability as an operating chassis to improve performance
in all areas of operations, including clinical delivery.
We must work to eradicate the slow growing cancers that erode the effec-
tiveness of our cultures. Our caregivers—physicians and nurses—are experi-
encing record levels of burnout, stress, and compassion fatigue. Most of this
is being driven by the increasing operational burden of healthcare, burden-
some information systems that add work due to poor human factors, design,
coupled with the taxing demands of taking care of patients. Burnout must be
recognized, validated, and organizations must take steps to deal with it.
Bullying remains prevalent in healthcare; both overt acts that are rela-
tively easy to recognize, and microaggressions, insidious personal attacks
which are more difficult to spot. It should trouble us that there are terms such
Culture: The Building Block for Successful Partnering with Patients xxi
as vertical and horizontal violence that describe how we interact with our col-
leagues: physicians, nurses, or staff intimidating their peers—that’s horizon-
tal violence; and those who intimidate their subordinates—that’s vertical
violence. Medicine has made progress but we have more work to do. This
author knows from personal experience that this type of emotional violence
is still rampant in medical and surgical training having experienced bullying
by staff physicians both as a resident and a fellow. It takes courage and per-
sonal responsibility to stand up against this behavior regardless of our role
and wherever we witness it, but we must if we are to promote the environ-
ments that will allow our people to flourish.
As leaders we must be mindful of the programs we develop and institute.
Despite our best intentions, we implement programs that work to erode our
culture. We create new initiatives couched in fancy slogans; our efforts to cut
costs become “cost repositioning,” or “value realignment,” or “care transfor-
mation.” We use these techniques to act as a crutch for our inability to effec-
tively communicate and manage change, and we insult our employees by
failing to give them credit for understanding the real meaning behind what we
are doing. This creates suspicion and fuels distrust, as our caregivers walk
around wondering, “… am I going to lose my job?” In such an environment,
the opportunity to message partnership and engagement is lost, and our cul-
tures suffer.
We must promote greater interprofessional cooperation and teamwork.
Nurses talk negatively about physicians, physicians talk negatively about
nurses, and often both professionals talk negatively about the organizations
and their leaders for which they work. Unfortunately much of this behavior
plays out in front of patients. Eliminating this childish, unprofessional behav-
ior requires us to improve teamwork, which is one of the ultimate ironies in
healthcare. We know the importance of high-performing teams in our indus-
try and we preach how essential it is to everything we do, but we spend little
time teaching it. Promoting teamwork and interprofessional relationships are
an element of our cultures and lead to a healthier working environment.
Healthcare workers often throw their colleagues under the bus for sport.
We will continue to fight these battles on the back end through cultural
development and transformation efforts, but we should find strategies to be
more proactive. Instead of investing all of our resources and putting all of our
focus on changing, what if we put some of our resources on developing peo-
ple before they ever reached our cultures? Organizations across the country
spend millions of dollars working to transform their people to work better
together, develop missing competencies, and enhance the work of managing
healthcare. Imagine if instead of retooling on the back end, healthcare
invested more on the front end to develop our professionals of the future.
Many physicians attended medical schools that were physically attached to
nursing schools, but not once in 4 years did those young aspiring profession-
als ever share a class together. There is some interaction when these students
begin their clinical exposure in hospitals, but usually they are learning in
parallel with little or no overlap or formal interaction. Even after graduation,
physicians are launched into their postgraduate training and nurses begin
their career in mostly separate trajectories.
xxii Culture: The Building Block for Successful Partnering with Patients
Not starting this process at the beginning, rather than later on in their
careers after they have established their own work patterns, is a lost opportu-
nity for all of us. Some academic organizations do this now, but the develop-
ment stops at graduation. Instead of having the experience learning stop at
graduation, what if we continue training doctors and nurses together—while
physicians are in postgraduate education and young nurses have started their
career? And not just cohorting doctors and nurses together, but other health
professionals as well.
Our mission is to teach the healthcare professionals of the future the skills
they need to be successful, but our imperative is to develop the humanity,
humility, truthfulness, and behaviors that form the culture of the organiza-
tions that we are responsible for leading. We can tackle this critically impor-
tant issue of cultural development by driving and insisting upon more
interprofessional education and interaction among aspiring professionals.
Patients come to medicine at the most challenged time of their lives with
anxiety, fear, despair, and uncertainty. Our collective responsibility is to pro-
tect them from harm and reduce their suffering by fulfilling our promise to
provide safe, high-quality care in an environment where they leave feeling,
knowing, and believing that we actually cared for them as people. This
requires us to raise the bar on improving safety, quality, and their experience.
While we struggle with many top-of-mind issues and competing interests, we
must be reminded of the need to keep patients at the center of our work, meet
their needs, and reduce their suffering. Healthcare will only be successful if
we recognize the need to improve our operations and reform our cultures to
become higher performing organizations.
James Merlino, MD
President and Chief Medical Officer
Press Ganey Strategic Consulting
Author of Service Fanatics: How to Build Superior Patient Experience
the Cleveland Clinic Way
References
1. Lehrman, W. G., Elliott, M. N., Goldstein, E., Beckett, M. K., Klein, D.,
& Giordano, L. A. (2010). Characteristics of hospitals demonstrating
superior performance in patient experience and clinical process measures
of care. Medical Care Research & Review, 67, 38–55.
2. Sacks GD, Lawson EH, Dawes AJ, Russell MM, Maggard-Gibbons M,
Zingmond DS, Ko CY. Relationship Between Hospital Performance on a
Patient Satisfaction Survey and Surgical Quality. JAMA Surg. 2015
Sep;150(9):858–64.
Preface
“The last part of surgery, namely operations, is a reflection on the healing art; it is a
tacit acknowledgment of the insufficiency of surgery. It is like an armed savage who
attempts to get that by force which a civilized man would get by stratagem.”
—Lectures on the Principles of Surgery at St. George’s in London, John Hunter, 1786
The field of surgery and surgical illness care has developed faster than nearly all
other fields in medicine. Although the fundamental biological substrates contrib-
uting to surgical disease are far from being completely understood and there are
great variations in the manifestations and complexity of illnesses, there are, nev-
ertheless, well-established treatment options for correction and palliation of
most medical conditions and the associated pathophysiology is, generally, well
understood. In recent years, global expenditures for health have risen substan-
tially, particularly for infectious diseases. Although conditions amenable to sur-
gery account for 28 % of the global burden of disease, the external funds directed
toward global surgical delivery are low. Given the large global demand for surgi-
cal care and the crosscutting nature of surgery, scale-up of basic surgical services
is crucial to strengthening health systems worldwide.
It seems, however, that despite unprecedented levels of spending on sur-
gical care, preventable medical and surgical errors have not been reduced,
uncoordinated care continues to frustrate patients, caregivers, and provid-
ers, and healthcare costs continue to rise. There are, of course, many pos-
sible factors at the root of these conditions, including the inexorable and
ongoing introduction of new technologies that alter rather than improve
systems of care, the lack of engagement of frontline staff in strategic deci-
sion-making and change, the lack of appreciation for the complex socio-
technical challenges in the operating room, and the limited but evolving
ability to collect and analyze meaningful clinical data as applied to quality
and safety metrics.
High reliability—or consistent performance at high levels of safety over
prolonged periods—is a hallmark for non-health-related, high-risk indus-
tries, such as aviation and nuclear power generation. Moving surgical care
from low to high reliability is centered on supporting and building a culture
of trust, transparency, and psychological safety among surgical team mem-
bers. This remains a major obstacle in moving healthcare toward safer, high-
valued care. In the face of health reform and increased competition in the
market, moving to high reliability requires adopting and supporting a culture
xxiii
xxiv Preface
Fig. 1 High-reliability organizations and their organizational culture*
that appreciates the relationships among a variety of organizational and tech-

nical risk factors and their effects on patient harm and procedural inefficiency.
This concept (Fig. 1) underscores the central role of creating an organiza-
tional culture of safety that enables improving surgical safety and quality and
providing high value surgical care. This requires that clinicians acknowledge
their primary responsibility to care for patients and their families as well as to
manage processes for optimization, standardization, and continuous measur-
ing and monitoring of outcomes.
This book focuses on safety, quality, and reliability along the surgical
health continuum, particularly the perioperative environment with its unique
socio-technical issues and challenges. The book is designed to grow a larger
appreciation for what brings surgical clinicians joy and supports their surgi-
cal expertise and how other experts can better design tools and systems that
can better meet clinician’s needs. While it is intended as a “go-to” resource
for all healthcare professionals that interact with surgical patients, it is pri-
marily designed for the frontline practitioner, those at the “sharp end.” The
strong interprofessional and cross-disciplinary orientation of this book is by
intentional design and is organized using a “systems” framework throughout
its pages using the conceptual model depicted (Fig. 2.)
There is worldwide fascination and concern with what happens in the
operating room, fueled by well-publicized breakthroughs, feats of technol-
ogy, but also investigations, inquiries, and sensational media. More recently,
apart from the occasional new gadgets developed to be used on patients,
attention has been directed at high variability and suboptimal surgical results.
A consistent theme in safety inquiries is that many staff, patients, and manag-
ers have raised concerns previously about the unsafe conditions under which
care is provided to patients. For example, the events surrounding the Veterans
Health Affairs scheduling affair, UK Bristol Royal Infirmary, the Japanese
Gunma Hospital Inquiry and the Canadian Manitoba Healthcare inquiries—
all came to light thanks to courageous whistleblowers—highlight the impor-
tance of climate of safety in which engaged leaders and clinicians appreciate
* The more I know, the less I sleep, Global perspectives on clinical governance. Lead
author Marc berg, Paul Barach co-author, KPMG Global Health Practice. December 2013.
Preface
PART I
FUNDAMENTALS OF SYSTEMS AND SAFETY SCIENCE
Emergency
Rehabilitation
Department
Intensive
Care Unit
Ambulatory Operating Nursing Home/
Pre-op Surgical Long Term Care
Care Theater Ward Facility
Recovery
Surgical
Room
Patient
Surgical Home
Ward
Family and
Pre-Hospital Patient Care Inpatient Care (including Pathology, Surgical Sterilization, Imaging) Surgical Home
Carers
PART II PART III PART IV

JOB AND ORGANIZATIONAL DESIGN PERIOPERATIVE QUALITY AND PATIENT SAFETY APPROACHES TO MANAGING RISKS
SECTION V
REGULATION, POLICY, AND THE FUTURE OF SURGICAL CARE
Fig. 2 Conceptual model.

xxv
xxvi Preface
the impact of human factors and systems effects in improving outcomes in

complex surgical procedures.
Several factors have been linked to poor outcomes in surgical care includ-
ing low institutional and surgeon- or operator-specific volumes, case com-
plexity, team coordination and collaboration, communication across elements
of care, clunky technology and human machine interfaces, and systems failures.
Safety and resilience in these organizations can be ultimately understood as a
specific characteristic of the system—the sum of all its parts plus its design,
relationships, and interactions. Further, many regulatory and government
agencies are examining more closely the impact of procedural volume, man-
agement of risk and mitigation strategies, and environments of care on the
outcomes of surgery in the field. Delivering reliable surgical care is complex,
challenging, and expensive and requires an “all hands on deck” approach.
The need for heightened situational awareness, heightened communication
practices, and an emphasis on the potential for failure should be essential
characteristics of the surgical workforce.
The expanding scope of procedures and technology in surgery adds expo-
nential complexity which is highly dependent on a sophisticated organiza-
tional structure, the coordinated efforts of a team of individuals, high levels
of cognitive and technical performance, and robust and reliable communica-
tions. Performance and outcomes have been shown to depend on complex
individual, technical, and organizational factors and the interactions among
them. These shared properties rely on the specific context of complex
team-based care, the acquisition and maintenance of individual technical and
nontechnical skills, the role and consequences of technology, and the impact
of working conditions on team performance.
The study of human factors is fundamentally about understanding how to
optimize socio-technical systems and the complicated relationship between
people, tasks, and dynamic environments. An organizational accident model
proposes that adverse incidents be examined both from an organizational per-
spective that incorporates the concept of active and latent conditions and from
an individual perspective that considers the cascading nature of human error.
Although a particular human action or omission may be the immediate or sus-
pected cause of an incident, a closer analysis usually reveals a preceding series
of events and departures from safe practices, usually influenced by the working
environment and the wider organizational context and working conditions.
Performance and outcomes depend on complex individual, technical, and
organizational factors and the interactions among them. Interventions to improve
quality and strategies to implement change should be directed to improve and
reduce variations in care and outcomes. To achieve these objectives, it is impera-
tive there be an appreciation of the relevant human factors on the ground, includ-
ing an understanding of the complexity of interactions between the:
• technical task
• treatment environment (noise, interruptions, distractions, etc)
• consequences of rigid hierarchies within the staff
• adequacy and completeness of briefing and debriefing
• cultural norms that resist change
Preface xxvii
In addition, the evolving regulatory environment employs strategies

such as public reporting and financial penalties for underperformance.
Proscriptive rules, guidelines, and checklists have the potential to raise
awareness and prevent harm; however, to provide a safe system for patients
and their families, we need to understand and improve systems, rethink
design and work practices, and sustain a nimbleness or innovation that sup-
ports developing resilience to recover from adverse events and to predict
and prevent future events.
We believe that innovation in surgical patient care is best designed in con-
cert with those on the front lines of healthcare delivery—patients and clini-
cians—and by incorporating relevant knowledge from other scientific
disciplines such as operations research, organizational behavior, industrial
and human factors engineering, and psychology. Our focus in this book is to
bring even more scientific discipline and measurement to the design, over-
sight, and measurement of surgical care to best engage all clinical and admin-
istrative healthcare professionals.
The editors feel that the ideas in this book could not be timelier and we are
indebted to the wonderful contributions from surgical leaders and experts
across many disciplines from around the world. We hope this book provides
readers with a roadmap for how to “think differently” as well as a common
reference source of current initiatives in outcomes analysis, quality improve-
ment, and patient safety, with the ultimate goal of advancing and optimizing
surgical care. Moreover, we hope the content and the authors of this text will
inspire readers, engagement, change, and that, through collaboration and
sharing, surgical care will be enriched and improved across the world. We
hope you will find this book helpful and trust you will enjoy reading it as
much as we have enjoyed preparing it.
References
1. Sanchez J, Barach P. High Reliability Organizations and Surgical Microsystems:
Re-engineering Surgical Care. Surgical Clinics of North America, 02/2012; 92(1):1–14.
DOI: 10.1016/j.suc.2011.12.005
2. The more I know, the less I sleep, Global perspectives on clinical governance. KPMG
Global Health Practice. December 2013.
Acknowledgements and Dedications
We would like to dedicate the book to all patients and their families who teach
us every day to do our very best. We wish to acknowledge Caroline Rutter who
provided excellent administrative assistance and Michael Griffin and the entire
Springer team, who guided us during the preparation of this book.
First and foremost, this book is dedicated to my wife, Lise, whose uncondi-
tional love, boundless patience, and great fortitude have allowed me to pur-
sue the noble profession of surgery. To Emily, Eric, and Daniel, with apologies
for all the missed times when Dad was “doing an operation.” I am very proud
of the woman and men you have become. Finally, to my parents whose wis-
dom, courage, and hard work made it possible, against all odds, for their two
children to succeed in a new country.
—Juan A. Sanchez
To the love of my life Julie, my best friend, and most trusted advisor, and my
three awesome boys, Harrison, Tore, and Elijah—they have inspired me to do
everything possible to improve healthcare. This has been possible by the wis-
dom and collaboration of my cherished colleagues and mentors. Finally, I want
to dedicate this book to my father, Harold Barach, a compassionate physician
who supported me on this book but who died in January, before the book was
completed. He profoundly shaped my life through his unconditional love and
started me on the journey of becoming a healer. And to my mother, Frances
Barach, who inspired me with love and guidance to never take no for an answer.
—Paul Barach
To the home team—Paul, my best friend and main collaborator, and our three
inquisitive boys. Harrison and Elijah Tore, who are growing into fine young
men.
—Julie K. Johnson
To my parents David and Marilyn Jacobs for giving me the opportunity, to my

wife Stacy for supporting and loving me, to our children Jessica and Joshua
for making us proud and motivated, and to our patients, who represent the
rationale for this initiative.
—Jeffery P. Jacobs
xxix
Contents
Part I Fundamentals of Systems and Safety Science
1 The Burning Platform: Improving Surgical Quality

and Keeping Patients Safe�� 3
Juan A. Sanchez and Kevin W. Lobdell
2 Risk Factors and Epidemiology of Surgical Safety�� 15
Oliver Groene
3 Concepts and Models of Safety, Resilience, and Reliability�� 25
Jonathan Gao and Sidney Dekker
4 Surgery Through a Human Factors and Ergonomics Lens�� 39
Ken Catchpole
5 The Relationship Between Teamwork and Patient Safety �� 51
Sallie J. Weaver, Lauren E. Benishek, Ira Leeds,
and Elizabeth C. Wick
6 Enterprise Risk Management in Healthcare �� 67
James M. Levett, James M. Fasone, Anngail Levick Smith,
Stanley S. Labovitz, Jennifer Labovitz, Susan Mellott,
and Douglas B. Dotan
7 The Patient Experience: An Essential Component
of High-Value Care and Service�� 87
Sara Shaunfield, Timothy Pearman, and Dave Cella
8 Patients and Families as Coproducers of Safe and Reliable
Outcomes�� 101
Helen Haskell and Tanya Lord
9 Tools and Strategies for Continuous Quality Improvement
and Patient Safety�� 121
Julie K. Johnson and Paul Barach
10 The Future and Challenges of Surgical Technology
Implementation and Patient Safety�� 133
Chandler D. Wilfong and Steven D. Schwaitzberg
xxxi
xxxii Contents
Part II Job and Organizational Design

11 Organizational and Cultural Determinants
of Surgical Safety �� 145
Kathleen M. Sutcliffe
12 The Role of Architecture and Physical Environment
in Hospital Safety Design�� 159
Charles D. Cadenhead, Laurie Tranchina Waggener,
and Bhargav Goswami
13 Building Surgical Expertise Through the Science
of Continuous Learning and Training �� 185
Peter Hani Cosman, Pramudith Sirimanna, and Paul Barach
14 Promoting Occupational Wellness and Combating
Professional Burnout in the Surgical Workforce�� 205
Ross M. Ungerleider, Jamie Dickey Ungerleider,
and Graham D. Ungerleider
15 Executive Leadership and Surgical Quality:
A Guide for Senior Hospital Leaders �� 225
Susan Moffatt-Bruce and Robert S.D. Higgins
16 Information Technology Infrastructure, Management,
and Implementation: The Rise of the Emergent
Clinical Information System and the Chief Medical
Information Officer �� 247
Jon David Patrick, Paul Barach, and Ali Besiso
17 Redesigning Hospital Alarms for Reliable
and Safe Care �� 263
Paul Barach and Juan A. Sanchez
18 Implementation Science: Translating Research
into Practice for Sustained Impact �� 277
Gregory A. Aarons, Marisa Sklar, and Nick Sevdalis
Part III Perioperative Quality and Patient Safety

19 The Leadership Role: Designing Perioperative
Surgical Services for Safety and Efficiency �� 297
Victoria M. Steelman and Martha D. Stratton
20 Operating Room Management, Measures
of OR Efficiency, and Cost-Effectiveness�� 313
Sanjana Vig, Bassam Kadry, and Alex Macario
21 The Science of Delivering Safe and Reliable
Anesthesia Care�� 327
Maurice F. Joyce, Holly E. Careskey, Paul Barach,
and Ruben J. Azocar
22 Enhanced Recovery After Surgery: ERAS�� 349
Jonas Nygren, Olle Ljungqvist, and Anders Thorell
Contents xxxiii
23 The Next Frontier: Ambulatory and Outpatient

Surgical Safety and Quality�� 363
Beverly A. Kirchner
24 Human Factors and Operating Room Design Challenges �� 373
Dirk F. de Korne, Huey Peng Loh, and Shanqing Yin
25 Diagnostic Error in Surgery and Surgical Services�� 397
Mark L. Graber, Juan A. Sanchez, and Paul Barach
26 Preventing Perioperative ‘Never Events’�� 413
Patricia C. Seifert, Paula R. Graling, and Juan A. Sanchez
27 Healthcare-Associated Infections in Surgical Practice�� 449
Scott J. Ellner and Affan Umer
28 Safer Medication Administration Through Design
and Ergonomics�� 461
Sheldon S. Sones and Paul Barach
29 Preventing Venous Thromboembolism Across
the Surgical Care Continuum �� 479
Lisa M. Kodadek and Elliott R. Haut
30 Preventing Perioperative Positioning
and Equipment Injuries�� 493
Lisa Spruce
31 Challenges in Preventing Electrical, Thermal,
and Radiation Injuries�� 519
Mark E. Bruley
32 Improving Clinical Performance by Analyzing
Surgical Skills and Operative Errors �� 555
Katherine L. Forsyth, Anne-Lise D’Angelo, Elaine M. Cohen,
and Carla M. Pugh
Part IV Approaches to Managing Risks

33 Perioperative Risk and Management of Surgical Patients�� 571
James M. Levett, Susan Mellott, Anngail Levick Smith,
James M. Fasone, Stanley S. Labovitz, Jennifer Labovitz,
34 Managing the Complex High-Risk Surgical Patient�� 589
Kevin W. Lobdell, B. Todd Heniford, and Juan A. Sanchez
35 Geriatric Surgical Quality and Wellness �� 613
Daniel J. Galante, JoAnn Coleman, and Mark R. Katlic
36 Patient Transitions and Handovers Across
the Continuum of Surgical Care�� 623
Donna M. Woods and Lisa M. McElroy
xxxiv Contents
37 Failure to Rescue and Failure to Perceive Patients in Crisis �� 635

Christian Peter Subbe and Paul Barach
38 A Quiet Revolution: Communicating and
Resolving Patient Harm�� 649
William M. Sage, Madelene J. Ottosen, and Ben Coopwood
39 It’s My Fault: Understanding the Role of Personal
Accountability, Mental Models and Systems
in Managing Sentinel Events�� 665
Elizabeth A. Duthie
40 Capturing, Reporting, and Learning from Adverse Events�� 683
Juan A. Sanchez and Paul Barach
41 How Not to Run an Incident Investigation�� 695
Bryce R. Cassin and Paul Barach
42 Multi-institutional Learning and Collaboration
to Improve Quality and Safety�� 715
Julie K. Johnson, Christina A. Minami, Allison R. Dahlke,
and Karl Y. Bilimoria
43 Lessons Learned from Anesthesia Registries
About Surgical Safety and Reliability�� 723
Richard P. Dutton
44 Use of Data from Surgical Registries to Improve Outcomes �� 737
Jeffrey P. Jacobs
Part V Regulation, Policy, and the Future of Surgical Care

45 How Regulators Assess and Accredit Safety and Quality
in Surgical Services�� 755
Stephen Leyshon, Tita Listyowarodojo Bach, Eva Turk,
Aileen Orr, Bobbie N. Ray-Sannerud, and Paul Barach
46 The Perioperative Surgical Home: The New Frontier �� 785
Juhan Paiste, Daniel I. Chu, and Thomas R. Vetter
47 Surgical Graduate Medical Education Program
Accreditation and the Clinical Learning Environment:
Patient Safety and Health Care Quality�� 799
John R. Potts III, Constance K. Haan, and Kevin B. Weiss
48 Affordable Care Act, Public Legislation,
and Professional Self-Regulation: Implications
for Public Policy �� 817
Stephen J. Lahey
49 Surgical Quality and Patient Safety in Rural Settings �� 827
Amy L. Halverson and Julie K. Johnson
Contents xxxv
50 Global Surgery: Progress and Challenges in Surgical Quality

and Patient Safety�� 837
Christopher Pettengell, Stephen Williams, and Ara Darzi
51 International Perspectives on Safety, Quality, and Reliability
of Surgical Care�� 849
Sertaç Çiçek and Hişam Alahdab
52 Surgical Safety in Developing Countries: Middle East, North
Africa, and Gulf Countries�� 859
Abdulelah Alhawsawi and Paul Barach
53 Future Directions of Surgical Safety�� 869
Timothy D. Browder and Paul M. Maggio
Epilogue�� 881
Index�� 885
About the Editors
Juan A. Sanchez, MD, MPA, FACS, FACHE is Chair of Surgery at

Ascension Saint Agnes Hospital, Associate Professor of Surgery, and
Associate Faculty at the Armstrong Institute for Patient Safety and Quality at
Johns Hopkins University in Baltimore, Maryland, USA. Dr. Sanchez, a
cardiothoracic surgeon, has a long-standing interest in surgical patient safety
and quality. A Six Sigma Black Belt, he has served on the Board of Examiners
of the Malcolm Baldrige Quality Award and as a founding member of the
Patient Safety Taskforce for the National Board of Medical Examiners.
xxxvii
xxxviii About the Editors
Paul Barach, MD, MPH is a Clinical Professor at Wayne State University

School of Medicine, a practicing clinician and researcher, and internationally
published writer and speaker on surgical safety, systems improvement, and
organizational change. He is interested in the organization and delivery of
healthcare services and in the development and application of strategies for
improving healthcare quality and outcomes, guided by theories and insights
from the fields of implementation science and healthcare quality improvement
research. He is involved in a variety of efforts to further develop and strengthen
the field of implementation science and to facilitate more effective collabora-
tions between researchers and policy and practice leaders interested in improv-
ing healthcare delivery. He is double board certified in Anesthesiology and
Critical care, from the Massachusetts General Hospital affiliated with Harvard
Medical School. He is a trained health services researcher, with advanced post-
graduate training in quality improvement from Intermountain Healthcare, and
in advanced medical education and assessment methods from the Harvard
Medical School Josiah Macy Program. He was inducted into the honorary soci-
ety for Anesthesia leaders (AUA), was Editor of BMJ Quality and Safety in
Healthcare journal, and has coauthored four books and over 400 publications.
About the Editors xxxix
Julie K. Johnson, MSPH, PhD is a professor in the Department of Surgery

and the Center for Healthcare Studies at Northwestern University in Chicago,
Illinois. Dr. Johnson uses qualitative methods to study processes of care with
the ultimate goal of translating theory into practice while generating new
knowledge about the best models for improvement. As a teacher, Dr. Johnson
has a special interest in developing and using serious games as a way to
engage learners around important concepts related to understanding and
improving the quality and safety of healthcare.
Jeffrey P. Jacobs, MD, FACS, FACC, FCCP is Chief of the Division of

Cardiovascular Surgery and Director of the Andrews/Daicoff Cardiovascular
Program at Johns Hopkins All Children’s Hospital. He is Professor of Surgery
and Pediatrics at Johns Hopkins University. He is Surgical Director of the
Heart Transplantation Program and the Extracorporeal Life Support Program
at Johns Hopkins All Children’s Hospital. He is Chair of the Society of
Thoracic Surgeons Workforce on National Databases, Co-Chair of the 2021
World Congress of Pediatric Cardiology and Cardiac Surgery, and Chair of
the Congenital Heart Surgeons’ Society (CHSS) Committee on Quality
Improvement and Outcomes.
Contributors
Gregory A. Aarons, PhD Department of Psychiatry, UC San Diego School

of Medicine, La Jolla, CA, USA
Hişam Alahdab, MD, FCCP Anadolu Medical Center, Pulmonary Diseases,
Istanbul, Turkey
Abdulelah Alhawsawi, MD, FRCSC, DABS Department of Surgery,
Faculty of Medicine and Allied Sciences, King Abdulaziz University, Jeddah,
Saudi Arabia
Ruben J. Azocar, MD, MHCM, FCCM Department of Anesthesiology,
Tufts Medical Center, Boston, MA, USA
Tita Listyowardojo Bach, PhD, DNV, GL, AS Strategic Research and
Innovation, Healthcare Program, Høvik, Norway
Paul Barach, BSc, MD, MPH, Maj (ret.) Children’s Cardiomyopathy
Foundation and Kyle John Rymiszewski Research Scholar, Children’s
Hospital of Michigan, Wayne State University School of Medicine, Detroit,
MI, USA
Lauren E. Benishek, PhD Department of Anesthesiology and Critical Care
Medicine, Armstrong Institute for Patient Safety & Quality, Johns Hopkins
University School of Medicine, Baltimore, MD, USA
Ali Besiso, MHI, BHSc Innovative Clinical Information Management
Systems (iCIMS) Pty Ltd., International Business Centre, Sydney, NSW,
Australia
Karl Y. Bilimoria, MD, MS Department of Surgery, Surgical Outcomes and
Quality Improvement Center, Feinberg School of Medicine, Northwestern
University, Chicago, IL, USA
Timothy D. Browder, MD Department of Surgery, Stanford Hospital and
Clinics, Stanford, CA, USA
Mark E. Bruley, CCE, BSc ECRI Institute, Plymouth Meeting, PA, USA
Charles D. Cadenhead, FAIA, FACHA, FCCM, B. Arch WHR Architects,
Houston, TX, USA
Holly E. Careskey, MD, MPH Department of Anesthesiology, Tufts
Medical Center, Boston, MA, USA
xli
xlii Contributors
Bryce R. Cassin, RN, BA Hons (Class 1) School of Nursing and Midwifery,

Hawkesbury Campus, Western Sydney University, Penrith, NSW, Australia
Ken Catchpole, BSc, PhD Department of Anesthesia and Perioperative
Medicine, Medical University of South Carolina, Charleston, SC, USA
Dave Cella, PhD Medical Social Sciences, Northwestern University,
Feinberg School of Medicine, Chicago, IL, USA
Daniel I. Chu, MD Department of Surgery, University of Alabama at
Birmingham, Birmingham, AL, USA
Sertaç Çiçek, MD, FACC, FCCP Center for Heart and Vascular Care,
Anadolu Medical Center, Cardiovascular Surgery, Istanbul, Turkey
Elaine M. Cohen, MEd Department of Surgery, University of Wisconsin
School of Medicine and Public Health, Madison, WI, USA
JoAnn Coleman, DNP, ACNP, AOCN Sinai Center for Geriatric Surgery,
Department of Surgery, Sinai Hospital, Baltimore, MD, USA
Ben Coopwood, MD, FACS Department of Surgery and Perioperative Care,
Dell Medical School, University of Texas at Austin, Austin, TX, USA
Peter Hani Cosman, BA, MBBS, PhD, FRACS, FICS Upper
Gastrointestinal and Hepatopancreaticobiliary Surgery, Western Sydney
University Clinical School, Liverpool Hospital, Liverpool, NSW, Australia
Richard Champion de Crespigny, AM, HonDUniv, GAICD,
FRAeS Aeronaut Industries Pty Ltd, Northbridge, NSW, Australia
Anne-Lise D’Angelo, MD, MS Ed Department of Surgery, University of
Wisconsin Hospitals and Clinics, Madison, WI, USA
Allison R. Dahlke, MPH Department of Surgery, Surgical Outcomes and
Quality Improvement Center, Feinberg School of Medicine, Northwestern
Dirk F. de Korne, PhD, MSc Medical Innovation & Care Transformation,
KK Women’s & Children’s Hospital, Singapore, Singapore
Ara Darzi, FRS, FMedSci, HonFREng Imperial College Healthcare NHS
Trust, Department of Surgery and Cancer, St. Mary’s Hospital, London, UK
Sidney Dekker, MA, MSc, PhD School of Humanities, Languages and
Social Science, Safety Science Innovation Lab, Griffith University, Brisbane,
QLD, Australia
Douglas B. Dotan, MA, CQIA Patient Safety Evaluation IT, CRG Medical,
Inc., Houston, TX, USA
Elizabeth A. Duthie, RN, PhD Patient Safety Resource Center, Montefiore
Medical Center, Bronx, NY, USA
Richard P. Dutton, MD, MBA US Anesthesia Partners, Park Ridge, IL,
USA
Contributors xliii
Scott J. Ellner, DO, MPH, MHCM, FACS Centura Health Physician

Group, Centura Health, Centennial, CO, USA
James M. Fasone, ARM, RPLU CRG Medical, Houston, TX, USA
Katherine L. Forsyth, MS Department of Industrial and System Engineering,
University of Wisconsin School of Medicine and Public Health, Madison,
WI, USA
Daniel J. Galante, DO Department of Surgery, Sinai Hospital of Baltimore,
Baltimore, MD, USA
Jonathan Gao, PhD Candidate School of Humanities, Languages and
Social Science, Safety Science Innovation Lab, Griffith University, Brisbane,
QLD, Australia
Bhargav Goswami, M. Arch, B. Arch WHR Architects, Houston, TX,
USA
Mark L. Graber, MD Society to Improve Diagnosis in Medicine, RTI
International, Plymouth, MA, USA
Paula R. Graling, DNP, RN, CNOR, FAAN Department of Surgery, Inova
Fairfax Medical Campus, Falls Church, VA, USA
Oliver Groene, PhD, MSc, MA OptiMedis AG, Hamburg, Germany
Department of Health Services Research and Policy, London School of
Hygiene and Tropical Medicine, London, UK
Constance K. Haan, MD, MS, MA Clinical Learning Environment Review
(CLER) Program, Accreditation Council for Graduate Medical Education,
Chicago, IL, USA
Amy L. Halverson, MD, FACS, FASCRS Section of Colon and Rectal
Surgery, Northwestern Medicine, Northwestern University, Chicago, IL,
USA
Helen Haskell, MA Mothers Against Medical Error, Columbia, SC, USA
Elliott R. Haut, MD, PhD, FACS Department of Surgery, The Johns
Hopkins Hospital, Baltimore, MD, USA
B. Todd Heniford, MD Division of Gastrointestinal and Minimally Invasive
Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, NC, USA
Robert S.D. Higgins, MD, MSHA Department of Surgery, Johns Hopkins
Medical Center, Baltimore, MD, USA
Jeffrey P. Jacobs, MD, FACS, FACC, FCCP Division of Cardiovascular
Surgery, Johns Hopkins All Children’s Heart Institute, Johns Hopkins All
Children’s Hospital, Johns Hopkins University, Saint Petersburg, FL, USA
Julie K. Johnson, MSPH, PhD Department of Surgery, Center for
Healthcare Studies, Institute for Public Health and Medicine, Feinberg
School of Medicine, Northwestern University, Chicago, IL, USA
xliv Contributors
Maurice F. Joyce, MD, EdM Department of Anesthesiology, Tufts Medical

Center, Boston, MA, USA
Bassam Kadry, MD Department of Anesthesiology, Stanford Hospitals and
Mark R. Katlic, MD Department of Surgery, Center for Geriatric Surgery,
Sinai Hospital, Baltimore, MD, USA
Beverly A. Kirchner, BSN SurgeryDirect LLC, Highland Village, TX, USA
Lisa M. Kodadek, MD Department of Surgery, The Johns Hopkins Hospital,
Baltimore, MD, USA
Jennifer Labovitz, BS, Manag. Econ. SurveyTelligence, an InfoTool
Company, Riviera Beach, FL, USA
Stanley S. Labovitz, BSBA, JD SurveyTelligence, an InfoTool Company,
Riviera Beach, FL, USA
Stephen J. Lahey, MD Division of Cardiothoracic Surgery, Department of
Surgery, University of Connecticut School of Medicine, UCONN Health,
Farmington, CT, USA
Ira Leeds, MD, MBA Department of Surgery, Johns Hopkins University
School of Medicine, and The Johns Hopkins Hospital, Baltimore, MD, USA
James M. Levett, MD, FACS Department of Surgery, UnityPoint St. Luke’s
Hospital, Cedar Rapids, IA, USA
Stephen Leyshon, MSc, MA, RN, DN, FHEA Strategic Research and
Olle Ljungqvist, MD, PhD Department of Surgery, Faculty of Medicine
and Health, Örebro University Hospital, Örebro, Sweden
Kevin W. Lobdell, MD Sanger Heart & Vascular Institute, Charlotte, NC,
USA
Huey Peng Loh, MHA Operating Theatre, Singapore National Eye Centre
(SNEC), Singapore, Singapore
Tanya Lord, PhD, MPH Patient and Family Engagement, Foundation for
Healthy Communities, Concord, NH, USA
Alex Macario, MD, MBA Department of Anesthesiology, Stanford
Hospitals and Clinics, Stanford, CA, USA
Paul M. Maggio, MD, MBA Department of Surgery, Stanford Hospital and
Lisa M. McElroy, MD, MS Department of Surgery, Medical College of
Wisconsin and Affiliated Hospitals, Milwaukee, WI, USA
Susan Mellott, PhD, RN Department of Nursing, Texas Woman’s University,
Houston, TX, USA
Contributors xlv
James Merlino, MD Press Ganey Associates, Strategic Consulting, Chicago,

IL, USA
Christina A. Minami, MD, MS Department of Surgery, Surgical Outcomes
and Quality Improvement Center, Feinberg School of Medicine, Northwestern
Susan Moffatt-Bruce, MD, PhD, MBA, FACS Quality and Operations,
The Ohio State University Wexner Medical Center, Columbus, OH, USA
Jonas Nygren, MD, PhD Department of Surgery, Ersta Hospital, Stockholm,
Sweden
Aileen Orr, BA (Hons), DNV, GL, AS Healthcare UK, London, UK
Madelene J. Ottosen, PhD, MSN, RN Department of Family Health,
UTHealth-Memorial Hermann Center for Healthcare Quality and Safety,
Houston, TX, USA
Juhan Paiste, MD, MBA Anesthesiology and Perioperative Medicine,
University of Alabama at Birmingham, Birmingham, AL, USA
Jon David Patrick, PhD, MSc, Dip LS, Dip BHPsch Innovative Clinical
Information Management Systems (iCIMS) Pty Ltd., International Business
Centre, Sydney, NSW, Australia
Timothy Pearman, PhD, ABPP Medical Social Sciences and Psychiatry &
Behavioral Sciences, Robert H. Lurie Comprehensive Cancer Center of
Northwestern University, Chicago, IL, USA
Christopher Pettengell, BMBCh, MA (oxon), MRCS Imperial College
Healthcare NHS Trust, Department of Surgery and Cancer, St. Mary’s
Hospital, London, UK
John R. Potts III Division of Accreditation Services, Accreditation Council
for Graduate Medical Education, Chicago, IL, USA
Carla M. Pugh, MD, PhD Department of Surgery, University of
Wisconsin—Madison, Madison, WI, USA
Bobbie N. Ray-Sannerud, PsyD, DNV, GL, AS Strategic Research and
William M. Sage, MD, JD School of Law and Dell Medical School,
University of Texas at Austin, Austin, TX, USA
Juan A. Sanchez, MD, MPA Department of Surgery, Ascension Saint
Agnes Hospital, Armstrong Institute for Patient Safety & Quality, Johns
Hopkins University School of Medicine, Baltimore, MD, USA
Steven D. Schwaitzberg, MD Department of Surgery, University at Buffalo
School of Medicine, Buffalo, NY, USA
Patricia C. Seifert, RN, MSN, CNOR, FAAN Cardiac Surgery Consultation,
Falls Church, VA, USA
xlvi Contributors
Nick Sevdalis, BSc, MSc, PhD Health Service & Population Research,

Institute of Psychiatry, Psychology & Neuroscience, King’s College London,
London, UK
Sara Shaunfield, PhD Medical Social Sciences, Northwestern University,
Chicago, IL, USA
Pramudith Sirimanna, MBBS, BSc General Surgery, Liverpool Hospital,
Liverpool, NSW, Australia
Marisa Sklar, PhD Department of Psychiatry and Human Behavior, Brown
University, Providence, RI, USA
Memorial Hospital of Rhode Island, Pawtucket, RI, USA
Anngail Levick Smith, BA, Soc, MA, Soc Operations, CRG Medical,
Houston, TX, USA
Sheldon S. Sones, BS Pharm, RPh, FASCP Safe Medication Management
& Pharmacy Consulting Services, Newington, CT, USA
Lisa Spruce, DNP, CNS-CP, CNOR, FAAN Association of PeriOperative
Registered Nurses, Denver, CO, USA
Victoria M. Steelman, PhD, RN, CNOR, FAAN College of Nursing, The
University of Iowa, Iowa City, IA, USA
Martha D. Stratton, MSN, MHSA, RN, CNOR, NEA-BC Doctors
Hospital of Augusta, Augusta, GA, USA
Christian Peter Subbe, DM, MRCP Department of Internal Medicine,
Ysbyty Gwynedd, Bangor, UK
School of Medical Sciences, Bangor University, Bangor, UK
Kathleen M. Sutcliffe, PhD Carey Business School, Johns Hopkins
University, Baltimore, MD, USA
Anders Thorell, MD, PhD Department of Surgery, Ersta Hospital,
Stockholm, Sweden
Eva Turk, PhD, MBA, DNV, GL, AS Strategic Research and Innovation,
Healthcare Program, Oslo, Norway
Affan Umer, MD Department of Surgery, Saint Francis Hospital and Medical
Center, Hartford, CT, USA
Graham D. Ungerleider Wake Forest University School of Medicine,
Advance, NC, USA
Jamie Dickey Ungerleider, MSW, PhD Wake Forest University School of
Medicine, Advance, NC, USA
Ross M. Ungerleider, MD, MBA Department of Surgery, Brenner
Children’s Hospital, Wake Forest Baptist Health, Winston Salem, NC, USA
Thomas R. Vetter, MD, MPH Anesthesiology and Perioperative Medicine,
University of Alabama at Birmingham, Birmingham, AL, USA
Contributors xlvii
Sanjana Vig, MD, MBA Department of Anesthesiology, Stanford Hospitals

and Clinics, Stanford, CA, USA
Laurie Tranchina Waggener, BSRC, RRT, BID, CHID, IIDA,
EDAC WHR Architects, Houston, TX, USA
Sallie J. Weaver, PhD, MHS Department of Anesthesiology and Critical
Care Medicine, Armstrong Institute for Patient Safety & Quality, Johns
Hopkins University School of Medicine, Baltimore, MD, USA
Kevin B. Weiss, MD Division of Accreditation Services, Accreditation
Council for Graduate Medical Education, Chicago, IL, USA
Clinical Learning Environment Review (CLER) Program, Accreditation
Council for Graduate Medical Education, Chicago, IL, USA
Department of Medicine and Center for Healthcare Studies, Northwestern
University Feinberg School of Medicine, Chicago, IL, USA
Elizabeth C. Wick, MD Department of Surgery, Johns Hopkins University
School of Medicine, and The Johns Hopkins Hospital, Baltimore, MD, USA
Chandler D. Wilfong, MD Department of Surgery, SUNY University at
Buffalo, Buffalo General Medical Center, Buffalo, NY, USA
Stephen Williams, BMBCh, MA (oxon), MRCS Imperial College
Healthcare NHS Trust, Department of Surgery and Cancer, St. Mary’s
Hospital, London, UK
Donna M. Woods, EdM, MA, PhD Center for Healthcare Studies, Institute
for Public Health and Medicine, Feinberg School of Medicine, Northwestern
Shanqing Yin, PhD, BSc Department of Quality, Safety, & Risk
Management, KK Women’s & Children’s Hospital, Singapore, Singapore
Part I
Fundamentals of Systems and Safety
Science
The Burning Platform: Improving
Surgical Quality and Keeping 1
Patients Safe
Juan A. Sanchez and Kevin W. Lobdell
“It must be considered that there is nothing more difficult to carry out, nor more doubtful
of success, nor more dangerous to handle, than to initiate a new order of things.”
—Niccolò Machiavelli, The Prince
need and others receive less, and yet others get

Introduction little access to care [4]. In this study, approxi-
mately 50 % of those seeking healthcare received
The ability of healthcare to save and extend life the recommended preventive care. For acute care,
and improve the quality of life for the ill is a tes- 70 % received the recommended treatment and
tament to the success of human competencies, 30 % of patients received contraindicated care.
technology and scientific inquiry. Perhaps as a For chronic diseases, 60 % of patients received the
result, most healthcare systems are challenged by recommended care and 20 % received contraindi-
issues of access, quality, and cost. Although most cated care. These studies strongly suggest that,
institutions and systems provide safe and effec- too frequently, care delivered in developed coun-
tive care for the vast majority of patients most of tries does not meet professional standards or best
the time, unwanted variation in quality and safety practices. In fact, the US healthcare system gets it
is common [1, 2]. The causes for this are many “right” only 55 % of the time [5].
and not always well understood but, in general, Adverse events in the course of delivering sur-
they result from [1] an increasingly complex gical care reminds us that “therapy” can harm
healthcare environment, [2] rapidly exploding patients, their families, and even front-line work-
medical knowledge; [3] poor evidence for the ers. The term “nosocomial conditions,” from nos-
treatments available; and [4] an overreliance on ocomium, (nosos, Greek, “disease”), an archaic
subjective judgment [3]. term for hospital, reflects the reality that these
A RAND Corporation analysis highlights conditions are caused by exposure to the health-
opportunities to improve the healthcare system in care system in contrast to the more specific term
which some people receive more care than they “iatrogenesis” (iatros, Greek, “physician”) in
which harm is caused as a result of an individual
physician [6]. This distinction highlights that sub-
J.A. Sanchez, MD, MPA (*)
Department of Surgery, Ascension Saint Agnes standard care and patient harm can no longer be
Hospital, Armstrong Institute for Patient Safety & attributable to one individual but are rooted in the
Quality, Johns Hopkins University School of characteristics of the system which conspires with
Medicine, Baltimore, MD, USA human fallibility to create opportunities for mis-
e-mail: [email protected]
takes, lapses, and unintended events [7].
K.W. Lobdell, MD While the identification of what is substandard
Sanger Heart & Vascular Institute,
PO Box 32861, Charlotte, NC 28232, USA medical care may be open to vigorous debate,
e-mail: [email protected] definitions of medical error and adverse events are
© Springer International Publishing Switzerland 2017 3

J.A. Sanchez et al. (eds.), Surgical Patient Care, DOI 10.1007/978-3-319-44010-1_1
4 J.A. Sanchez and K.W. Lobdell
much more obvious and there is ample evidence Table 1.1 The Institute of Medicine’s six aims for
healthcare system redesign
that the current surgical environment is dangerous
and can unintentionally harm patients [8, 9]. Healthcare should be
It is important to distinguish poor outcomes due • Safe
to the nature and progression of disease and • Effective
expected rates of complications from substandard • Patient centered
medical care. Unfortunately, this distinction is not • Timely
always obvious and poor outcomes are often misat- • Efficient
tributed to patient comorbidity. Additionally, evi- • Equitable
dence-based medicine and tools to standardize
processes of care (care pathways and treatment of patient safety and quality and called for system
algorithms) may not be properly implemented or redesign by defining six major aims for system
may not produce the desired results. This chapter is transformation (Table 1.1) [21].
intended to provide a broad overview of the major
factors contributing to the disparity between the
practices we know are effective and the real-world Threats to Patient Safety
state of surgical care with the intention of helping
perioperative teams “hardwire” optimal processes Progress in science and technology has led to
and practices to close this gap [10]. dramatic, worldwide improvements in health and
Each member of the healthcare team must be longevity. However, this progress is associated
skilled, competent, and unbiased in their ability to with a level of complexity, distractions, and sys-
choose the right therapy for their patients [11]. The tem opacity, which hampers our ability to reli-
healthcare system fails when thoughts, decisions, ably produce optimal and safe outcomes [22].
and actions deviate from this fiduciary and ethical Healthcare can be viewed as a complex adap-
duty. Patient safety can be seen as the “low-hang- tive system and concepts from complexity science
ing fruit” of the quality “tree.” Efforts to improve and engineering will undoubtedly play an increas-
quality must begin with avoiding patient harm ing role in the design of new care delivery systems
[12]. Evaluation and reporting of “near misses” is and models [3]. Numerous studies document the
an essential activity in order to promote organiza- worldwide unacceptable rates of patient harm and
tional learning and continuous improvement [13]. the negative consequences of variations in care
Reporting, however, alone does not appear to cap- [23–29]. In addition, poor quality, i.e., the differ-
ture many of these events [14–18]. Quality cannot ence between optimal outcomes and what actually
be reliably improved when unsafe systems, unmit- exists, is characterized by overuse, underuse, and
igated hazards, and other safety-related issues per- misuse of healthcare resources [30–35]. Although
sist throughout the system. progress to date has been slow, continued efforts to
Numerous studies have concluded that “the understand the root causes of suboptimal levels of
burden of harm conveyed by the collective impact quality will ultimately lead to a more reliable,
of all of our health care quality problems is stag- high-value healthcare system [36, 37].
gering” [19]. In “To Err is Human: Building a Poor quality and errors stem from a frag-
Safer Health System (1999)” and its subsequent mented, multilayered, and “siloed” system of care
publication “Crossing the Quality Chasm: A New with diffuse accountability, staggering amount of
Health System for the 21st Century (2001),” the information, and pressures to function at the mar-
Institute of Medicine highlighted the serious and gins of the system’s capacity [38]. When com-
pervasive nature of the US healthcare quality bined with human fallibility, complexity leads to
problem [20, 21]. These have become clarion process variability and poorly coordinated medi-
calls suggesting that reforms at the margins are cal care as well as inconsistent standards and
inadequate and that a true transformation of the inadequate care transitions (Table 1.2) [7, 39].
healthcare system is required. These and other Other factors such as strong production pressures,
reports raised the public consciousness the issues time constraints, and a rigidly hierarchical culture
1 The Burning Platform: Improving Surgical Quality and Keeping Patients Safe 5
Table 1.2 System threats to safety [39] unately, surgical team members still have low hand
• Complexity washing compliance rates upon entering the operat-
• Variability ing room ranging from 2.9 to 10 %, thus contributing
• Inconsistent standards to surgical infections [43, 44]. Unfortunately, HAIs
• Poor care transitions affect 5–10 % of all hospitalized patients in the USA
• Absence of error traps and barriers (e.g., forcing annually [42]. HAIs such as surgical site infections,
functions) pneumonia, and infections of implanted devices can
• No training to handle the unexpected lead to death or serious chronic disability and are
• Time constraints largely if not entirely preventable.
• Hierarchical culture
In New York City, hospital-acquired staphylo-
• Human fallibility
coccus infections alone cost $400 million. In
2014, a survey by the CDC which described the
also contribute to a system of unreliable, inconsis- burden of HAIs in US hospitals reported that
tent, and too often dangerous care. about 75,000 patients with HAIs died during their
hospitalizations [42]. More than half of these
occurred outside of the intensive care unit. Most
alarming is that many hospital-acquired bacterial
Avoidable Errors infections have developed resistance to, at least,
one of the antibiotics traditionally used to treat
Many patients are injured during the course of them [45]. Antibiotic stewardship and infection-
their treatment and some die from these injuries. reduction programs include discriminate antibi-
In New York hospitals, for example, 3.7 % of otic therapy as well as reliable use of appropriate
patients out of 30,121 randomly selected records infection prevention measures (hand hygiene,
suffered adverse events during their hospitaliza- skin preparation and depilation techniques,
tion and approximately 70 % of these resulted in gloves, gowns, air handling, cleaning, etc.) [46].
disability lasting less than 6 months, 2.6 % caused
permanently disabling injuries, and 13.6 % led to
death [25]. In a study of hospitals in Colorado
and Utah, surgical adverse events accounted for Profiles in Surgical Patient Safety
two-thirds of all events [40].
Serious, entirely preventable surgical events,
known as “never events,” continue to occur despite
extensive efforts to thwart them. Perioperative
mistakes such as retained surgical equipment,
burns and positioning injuries, as well as wrong-
site, wrong-patient, and wrong-procedure events
should never occur in any patients [9, 41]. When
combined with other events such as medication
errors, accidental punctures and lacerations, and
other mistakes, these events constitute consider-
able aggregate risk for the surgical patient.
The US Centers for Disease Control and
Prevention (CDC) estimates that each year 1.7 mil-
lion HAIs occur in US hospitals each year, resulting
in 99,000 deaths and an estimated $20 billion in
healthcare costs [42]. Healthcare- acquired condi-
tions such as infections are a costly plague to patients
and the healthcare system. When patients are admit-
ted to a hospital, they should not suffer a preventable Ignaz Philipp Semmelweis: The Epidemiologic
Approach to Patient Safety [47, 48]
healthcare-associated infection (HAI). Unfort
ogy or methods for which there is no evidence or

Puerperal “(childbed) fever in Vienna dur- wide acceptance. Much practice variation and
ing the 1840s resulted in high rates of mor- many clinical decisions seem to be influenced by
tality for both mother and child following non-patient-related factors such as geographic,
delivery. Dr. Semmelweis, a German- age- related, racial, socioeconomic, and ethnic
Hungarian physician, found that the preva- disparities that have been demonstrated to exist
lence of this condition varied between two for a variety of conditions [52–56].
different obstetrical clinics. By analyzing The rates of many surgical procedures includ-
records at the Vienna General Hospital, he ing vascular surgery, coronary artery bypass oper-
correlated the rise in the rate of this condi- ations, lung surgery, and other types of procedures
tion at the clinic attended by physicians vary as much as tenfold across geographic regions
with the institution of postmortem exami- [1, 2, 49, 52, 57, 58]. Substantial practice varia-
nations at the hospital. The other maternity tion has also been shown to exist between sur-
clinic, which was exclusively staffed by geons, even within the same medical center [59].
midwives, had a threefold lower incidence For example, when selecting patients with pros-
of childbed fever. Semmelweis proposed tate cancer for radical prostatectomy, a study
that the practice of washing hands with demonstrated considerable variability among sur-
chlorinated lime solutions in 1847 reduced geons at a high-volume academic center [60]. The
mortality to below 1 %. The notion that study suggested that publicly reporting individual
physicians could transfer disease from the practice patterns at the surgeon level could poten-
autopsy room to other patients resulting in tially decrease the overtreatment of low-risk pros-
their death was strongly resisted and doc- tate cancer [61]. These phenomena are not due
tors were offended at the suggestion that solely to insurance coverage variations and they
they should wash their hands. His ideas are well found in countries with universal health
earned widespread acceptance only after coverage such as Great Britain and Canada [62].
his death, when Louis Pasteur confirmed In another example, poor adherence to well-
the germ theory and Joseph Lister devel- accepted national guidelines for preoperative
oped other hygienic methods. Semmelweis’ testing has been shown to lead to overuse. Feng
findings laid the groundwork for the sci- et al. found that women undergoing mid-urethral
ence of hospital epidemiology and efforts sling surgery were subjected to unnecessary
to control healthcare-associated infections. testing during preparation for surgery [63]. In
Ignaz Semmelweis 1860 (Copper plate this study, approximately two-thirds of complete
engraving by Jenő Doby) Benedek, István blood counts and coagulation profiles were not
(1983) Ignaz Phillip Semmelweis 1818– indicated. Additionally, 22 % of chest radio-
1865, Gyomaendrőd, Hungary: Corvina graphs and 6 % of electrocardiograms were not
Kiadó ISBN: 9631314596. plate 15. Public obtained despite being indicated. One study dem-
Domain onstrated that 31 % of patients undergoing total
knee arthroplasty did not have an indication for
the procedure and an additional 21 % had incon-
clusive indications [30].
Variation The appropriateness criteria have not been
developed for most common surgical procedures
Research indicates that unnecessary variation and many of the existing ones are outdated [32,
harms patients, leads to poor quality, and results 34, 64–69]. It is anticipated that investments in
in high levels of waste [2, 49–51]. Furthermore, it comparative effectiveness research will yield
appears that much of the current variation in sur- meaningful contributions towards the develop-
gical care reflects inconsistent application of ment of appropriateness criteria and reduce prac-
evidence-based practice standards as applied to tice variation in the future. A broad, coordinated
clinical decision making and the use of technol- effort will be required to ensure adherence to
practice guidelines and other tools which pro-

mote the application of evidence-based practice Probably most known for her work during
standards to address variation in the use of surgi- the Crimean War where Florence
cal procedures. Ultimately, an approach which Nightingale found camp hospitals over-
incorporates a shared decision-making paradigm crowded, undersupplied, and unsanitary.
involving patients and physicians should ensure She transformed hospitals into a healthy
that proper diagnostic evaluation has been done and healing environment resulting in a
and appropriate treatments are offered [67]. drop in mortality from 40 to 2 % [74].
Studies have found that only between 10 and Nightingale’s statistical data analysis of her
20 % of routine medical practice has a basis in sci- experiences led to significant advances in
entific research [70–72]. Much of what is done in public health throughout Britain. Under her
clinical practice is based on tradition or opinion in leadership, nurses helped transform hospi-
the absence of valid clinical knowledge or with tals from places to die to sanctuaries of care.
inadequate evidence for what is best for a given Her influential book “Notes on Nursing:
patient. Quite often, these treatments are effec- What it is, and What it is Not” described
tive, but the lack of concrete data underscores the that hygiene, sanitation, fresh air, proper
need for healthcare organizations and individual lighting, a good diet, quiet, and comfort
practitioners to follow their outcomes and com- were necessary conditions for hospitals.
pare them to other centers. Risk-adjusted surgical Nightingale established a Nursing School at
registries such as the American College of St. Thomas’ Hospital in 1860 to teach her
Surgeons’ National Surgical Quality Improvement principles of nursing practice [75]. Her stu-
Program (NSQIP) allow opportunities for dents went on to staff many hospitals in
improvement to continuously improve the effi- Britain and abroad and spread her nursing
ciency and effectiveness of surgical care [73]. education system to other countries.
Through her work on hospital operations,
sanitation, and other public health issues, as
Profiles in Surgical Patient Safety well as contributions to healthcare statistics,
she is responsible for elevating the profes-
sion of nursing to professional status.
Overuse
Effective care occurs when the benefits of an

intervention outweigh the risks. Overuse occurs
when patients receive treatments, tests, or medi-
cations when there is no evidence that such treat-
ment will improve a patient’s outcome and may
expose the patient to unnecessary risks. The asso-
ciated cost from overuse is staggering, particu-
larly for certain conditions and procedures. It has
been estimated, for example, that the number of
unnecessary hysterectomies in the USA impacts
Florence Nightingale: Nursing Pioneer approximately 80,000 women and adds a cost of
$320 million annually [76].
Underuse to medications with devastating effects [71, 81]. In

culturally and ethnically diverse populations, indi-
Underuse occurs when healthcare providers viduals with limited language skills or literacy are
neglect to give patients medically indicated care also vulnerable to disparities and communication
or to fail to follow accepted practices. Care for failures often occur which potentially lead to mis-
vulnerable individuals such as the elderly and understandings and errors [82–84].
children falls short of acceptable standards for a
wide variety of conditions. Patients do not receive
the appropriate and timely care necessary which Measuring Surgical Quality
often leads to additional and more severe compli-
cations resulting in poor outcomes and adding to Quality can be assessed both explicitly and
healthcare costs needlessly. An in-depth study of implicitly. Explicit quality measures are devel-
lower extremity vascular procedures for critical oped prospectively and are well defined. Explicit
limb ischemia, for example, showed a significant measures are evidence based and their construct
variability of amputation rates when comparing validity and reliability have been verified through
areas with different intensity of vascular care independent observations. Unfortunately, the
suggesting that patients in some areas are far less majority of surgical care currently can only be
likely to receive limb salvage procedures [77]. evaluated implicitly. Implicit measurements of
quality are generally based on subjective evalua-
tion [67, 85–87]. While clinical databases and
disease registries such as NSQIP and the Society
Disparities in Surgical Care of Thoracic Surgery’s National Databases have
developed well-defined process and outcome
The care provided to different segments of the measures, they are only applicable to a limited
population does not appear to be evenly distrib- range of surgical procedures and participation is
uted and many studies have documented racial and voluntary [73, 88]. Much of what constitutes
socioeconomic disparities in both treatments and “surgical care” currently falls outside the range
outcomes [54–56]. For example, in patients with of our ability to objectively compare and mostly
early-stage non-small-cell lung cancer (NSCLC), relies on subjective interpretation. Furthermore,
receiving of curative-intent surgery was signifi- implicit quality measures are based on expert
cantly less for black patients than for whites in judgment by peers or by proxies of quality
every state in the USA [52]. Such unequal care has including processes of care but do not measure
been documented for a number of different surgi- true quality. For example, using the perspective
cal treatments such as obesity surgery, cancer care, of the three domains of quality proposed by
and cardiovascular procedures [2, 62, 78]. Donabedian (structure, process, and outcomes),
Disparities also occur in populations with spe- structural measures such as hospital or surgeon
cial vulnerability to adverse events such as the volume are relatively easy to obtain [85].
very old, mentally ill, trauma patients and the very However, the relationship between volume and
young often due to their inability to participate quality is not always clear. In general, hospitals
actively in their own care mainly due to communi- or surgeons performing large numbers of a par-
cation barriers [53, 79]. Older people, for example, ticular surgical procedure may have lower mor-
may suffer varying degrees of impairment in tality; however, other factors including severity
vision and hearing as well as cognitive deficits and case-mix and other unmodifiable, often, intangi-
may not be able to understand or communicate ble factors also contribute to poor results.
with their caregivers. These problems are com- Adjusting for risk requires the use of sophisti-
pounded when serious illness or trauma occurs cated analytic methods with inherent limitations
contributing to these difficulties and potentially and not all risk factors can be captured.
leading to errors [80]. Infants and children are also Furthermore this approach is currently limited to
at greater risk of serious errors particularly related a narrow range of procedures.
events (i.e., surgical infections) makes a causal

Profiles in Surgical Safety inference difficult in the practitioner’s mind.
Reporting a limited number of process and struc-
ture measures does not provide a true picture of
surgical quality and may not get at the root causes
of poor outcomes [91]. In contrast to structure and
process, measures of outcome provide a more
global assessment of quality and are what ulti-
mately matters most to patients [92]. The use of
outcome measures as indicators of surgical qual-
ity is difficult and complicated by confounding
variables and other factors. Adjusting for risk fac-
tors is not an exact science and insufficient evi-
dence exists as to what specific prognostic factors
actually impact outcomes. Additionally, there are
multiple methodologies for case-mix adjustment
and the use of these different methods can poten-
Ernest Amory Codman and Hospital tially provide differing results [93].
Standardization [89] How does one determine what is an accept-
able outcome in, say, herniorrhaphy? Is it an
A Boston surgeon, Dr. Codman is known absence of hernia recurrence at 30 days? At a
more than anything else for his advocacy of year? Most current surgical outcome measures,
the “End Result Idea,” the premise that as reported to registries and regulatory agencies,
hospital staffs should follow every patient are limited to in-hospital or 30-day mortality and
they treat long enough to determine morbidities [32]. Peer review of other outcome
whether or not the treatment was success- measures such as readmissions, infections, and
ful, and then learn from failures and how to complications, ostensible defects in the provision
avoid them. Although controversial at the of surgical care, may be of some value but is dif-
time, his ideas were the basis for the subse- ficult to collect if patients do not always return to
quent hospital standardization movement the same institution for care particularly if the
advanced by the American College of procedure is done at independent facilities such
Surgeons, and were the precursor to the as free-standing ambulatory surgery centers
Joint Commission in the USA. The Joint (ASC) unless a mechanism exists regionally to
Commission is an organization devoted to capture this information.
setting standards of healthcare quality The importance of accurately collecting clini-
worldwide. Dr. Codman was a crusader for cal indicators of surgical quality cannot be over-
data-driven, evidence-based, and patient- stated. This information is central to improving
centered surgical care. quality and the feedback allows individual hospi-
tals and surgeons to gauge and monitor their own
quality and compare themselves to other centers
Certain process measures, such as the timeli- and practitioners using an “apples-to-apples”
ness and appropriateness of administering prophy- (i.e., risk-adjusted) approach. Public information
lactic antibiotics, are currently in use as an index on relative rankings of surgeons or institutions
of surgical quality for the purpose of payment of may stimulate improvement and the formation of
hospitals in the USA [90]. This approach to ensur- intramural and multiorganizational collaborative
ing quality using vetted, evidence-based metrics groups coalescing around quality and sharing
may address the lowest common denominator but best practices. When data used for analysis is
it relies on a process that is only indirectly related based on information reported following dis-
to outcomes and the infrequency of the adverse charge and abstracted by trained but nonclinical
coders, only the most obvious and direct outcome poor quality, inappropriate variability, and medi-
measures can be reliable. Such use of administra- cal errors is central to delivering value to the sur-
tive data, generated for the purpose of obtaining gical patient. The surgical environment is a
reimbursement by hospitals, may not reflect socio-technical system with great complexity and,
actual clinical quality although this data is often thus, “target rich” for mitigating hazards and
more accessible and less costly to acquire. addressing poor and inconsistent quality.
Meaningful change will require an “all-hands-on-
deck” approach by surgeons, nurses, and others
involved in the care of surgical patients in transi-
Profiles in Surgical Patient Safety tioning to a team-oriented, systems-based work.
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Risk Factors and Epidemiology
of Surgical Safety 2
Oliver Groene
“You cannot swim for new horizons until you have courage to lose sight of the shore.”
—William Faulkner
omission. Others suggest a broader definition that

Framework to Study Errors
A covers patient harm resulting from acts of commis-
and Harm sion (affirmative actions such as incorrectly con-
ducted procedure) or acts of omission (such as
Hundreds of people are admitted to hospitals failure to treat a condition), as well as unintended
every year. In the UK, there are about 17 million complications of healthcare [3]. Preceding harm
hospital admissions annually; about one-third of and adverse events are incidents or near misses,
admissions are for a surgical procedure. In high- unintended or unexpected incident that could have
income countries most procedures are conducted harmed patients, but did not [4].
safely; yet, unfortunately some patients experi- In this chapter we consider harm as an adverse
ence adverse events, resulting in harm or even outcome of structural and process factors within
death. The proportion of patients experiencing hospitals. Brown et al. proposed a framework to
harm remains significant, despite the major focus study these relationships, building on Donabedian’s
on improving patient safety in the last decade [1]. structure-process-outcome model and the work of
There are many ways to define harm. The WHO/ James Reason on latent and active errors [5]. In
World Alliance for Safer Healthcare defines health- the framework, management processes cover for
care-related harm as ‘an injury arising from or example human resource policies: training of new
associated with plans or actions taken during the staff or management of the supply chain. Latent
provision of healthcare, rather than an underlying errors related to such management processes
disease or injury’ [2]. Harm may result in tempo- might expose clinicians to outdated work practices
rary or permanent lessening of body sensory, motor, or indirectly put patients at risk. Clinical processes
physiologic or intellectual function. The definition cover the adoption of particular safety/evidence-
clearly relates harm to actions of healthcare provi- based practices and the quality of procedure.
sion although it fails to capture harm from acts of Active errors in clinical processes directly put
patients at risk and may cause harm or death. The
model is important for an understanding of a sys-
O. Groene, PhD, MSc, MA (*) tems perspective on latent and active errors, and
OptiMedis AG, Burchardtstrasse 17, the complex relationship between wider manage-
Hamburg 20095, Germany ment processes, clinical processes, and patient
Department of Health Services Research and Policy, outcomes [6]. Latent and active errors may lead to
London School of Hygiene and Tropical Medicine, an adverse event (or patient incident), but not all
Tavistock Place 17-19, WC1H 9SH London, UK
e-mail: [email protected]; adverse events also cause a permanent harm to the
[email protected] patient (Fig. 2.1).

16 O. Groene
Fig. 2.1 General and specific interventions across the system and evaluation end points (modified from Brown et al.)
This epistemology of surgical safety is appli- amount of harm caused by surgery remains a
cable to a wide range of settings. In low-income challenge, as the nature of surgery changes and
countries many people don’t have access to safe becomes much more complex, involving an ever-
surgery and the study of surgical safety differs increasing number of team members in surgical
methodologically, because of lack of access to preparation, conducting the procedure and pro-
high-quality data and care. viding complex follow-up care.
Nevertheless, data on surgical safety in low- For example, the number of team members
or middle-income countries is starting to emerge (surgeons, anaesthesiologists, operating room
[7]. It represents a significant problem, especially nurses) directly involved in a typical surgical pro-
considering the global strategy towards universal cedure might be, six, but the total number of staff
healthcare coverage (which currently may imply involved in organising, administering and deliver-
access to unsafe surgical practices). ing the clinical care process leading to, and fol-
lowing from, the surgery might be ten times this
number [9]. Due to the complexity of the care
The Scale of Harm in Surgery pathway, perioperative care processes are becom-
ing more prone to both latent and active errors.
There have been major achievements in surgery Patients may experience severe harm and even
in the last 100 years, made possible through infec- death even if the actual surgical operation is
tion prevention, safe anaesthesia, modern opera- uneventful, because of latent and active errors in
tion theatres and minimal invasive techniques. recognising and effectively managing a major
The World Health Organization (WHO) estimates complication following the surgery [10, 11].
that about 234 million major surgical procedures The United Kingdom’s National Reporting
are undertaken every year worldwide [8]. Despite and Learning System (NRLS), the largest reposi-
improvements in surgical safety, reducing the tory of patient safety incidents worldwide, gives
2 Risk Factors and Epidemiology of Surgical Safety 17
Table 2.1 Selected results of retrospective care record reviews (after deVries [13])
Harvard Quality in
Medical Australian Utah and Adverse events in Canadian
Practice Health Care Colorado Vincent et al. New Zealand Adverse Event
Study study study Study study Public Hospitals Study
Country USA Australia USA England New Zealand Canada
Year 1984 1992 1992 1998 1998 2000
Cases reviewed 30,121 14,179 14,700 1014 6579 3745
Adverse event rate 3.8 % 16.6 % 3.9 % 10.8 % 11.2 % 6.8 %
Preventable 1.0 % 8.5 % 0.9 % 5.2 % 4.8 % 2.8 %
adverse events
an indication of the scope of incidents and harm: individual studies, mainly because the methods
About 1.3 million incidents were reported by and the definition of harm varied.
NHS organisations between July 2011 and June Selected results of seminal retrospective care
2012 in England, although it is recognised that record reviews are presented in Table 2.1.
probably only about 25 % of incidents in hospitals Key areas for surgical safety relate for exam-
are reported. The majority of incidents (875 k) ple to site infections, anaesthesia or retention of
caused no harm, with 7773 causing severe harm instruments [14]. Surgical site infections account
and 3263 resulting in death. The most common for 15 % of all nosocomial infections and in sur-
type of incident reported was a patient accident gery represent the most common nosocomial
(25.8 %), followed by treatment/procedure infection (37 %) [15]. The overall risk of acquir-
(12.7 %) or medication error (12.1 %) [12]. ing a surgical site infection is low (2–5 % of all
The most detailed data on patient harm comes surgical patients); however, considering the vol-
from retrospective care record reviews. This ume of operations the absolute number of surgi-
method traditionally consists of two stages: a cal infections is significant. Patients with a
nurse reviewer identifies patient records where surgical site infection need a longer hospital stay,
certain preset criteria suggests patient harm, fol- have higher rates of readmission and are at high
lowed by a second-stage review by an experienced risk of substantial permanent morbidity, or mor-
clinician who judges whether patient harm indeed tality [16]. The retention of objects after surgery
occurred, and whether it was due to acts of omis- is another rare event, but where it happens it can
sion or commission. Compared to routine data cause major morbidity and mortality. A study at
sources, the method has the advantage of being the Mayo clinic found that in one of every 5500
based on a rich description of the care pathway operations a foreign object was retained, in the
and supported by explicit standards and criteria. majority of cases (68 %) surgical sponges. The
However, the review has also been shown to have greatest risk from retained objects is an infection,
low inter-rater reliability, particularly regarding but surgical instruments can also cause perfora-
the assessment of the causes of patient harm and tions and granulomas [17]. Anaesthesia has
its preventability. become very safe in developed countries. Studies
A meta-analysis of the seminal retrospective vary in suggesting that an adverse event leading
case record reviews, which included 74,485 to death occurs in every 10,000 to every 185,000
patients, found an adverse event rate of 9.2 %. Of patients; that is, even in the worst case an
these nearly half (43.5 %) were deemed prevent- anaesthesia-related death will be a very rare event.
able [13]. Surgery was the largest area where However, in developing countries anaesthesia rep-
adverse events occurred (39.6 % of all cases), fol- resents a tangible risk, leading to a death in every
lowed by drug-related events (15.1 %). The rates 3000 patients (Zimbabwe) or even every 150th
of harm measured differed substantially between patient (Togo). The causes are predominantly
18 O. Groene
related to airway problems or anaesthesia in the

presence of hypovolaemia. Text Box 2.1: Strongly Encouraged Patient
Despite the advances in surgical safety, with Safety Practices (Modified from Shekelle
the increasing volume of operations and the com- et al.)
plexity of procedures and team organisation a sys- • Preoperative checklists and anesthesia
tematic approach towards improving perioperative checklists to prevent operative and post-
safety is needed. Considering the large volume of operative events
surgical procedures and the rates of harm caused • Bundles that include checklists to pre-
by surgery, WHO considers surgical safety as a vent central line-associated bloodstream
public health crisis, particularly in low-income infections
countries. • Interventions to reduce urinary cathe-
ter use, including catheter reminders,
stop orders, or nurse-initiated removal
olutions to Prevent Errors
S protocols
and Harm in the Perioperative • Bundles that include head-of-bed eleva-
Arena tion, sedation vacations, oral care with
chlorhexidine and subglottic suctioning
Since the publication of the influential ‘To Err is endotracheal tubes to prevent ventilator-
Human’ report in the year 2000, there has been associated pneumonia
substantial increase in research on improving sur- • Hand hygiene
gical safety. Early findings on evidence-based • The do-not-use list for hazardous
strategies are summarised in the AHRQ report abbreviations
‘Making Health Care Safer: A Critical Analysis • Multicomponent interventions to reduce
of Patient Safety Practices’ [18]. However, the pressure ulcers
report also identified major gaps in knowledge, in • Barrier precautions to prevent health
particular the limitations in the epistemology for care-associated infections
the study of patient safety, the relevance of con- • Use of real-time ultrasonography for
text factors for the implementation and the impact central-line placement
of the broader health system environment. Since • Interventions to improve prophylaxis for
then a major international effort has focused on venous thromboembolisms
reviewing patient safety practices, supporting
original research and widening the scope of
implementation efforts. An update of strategies
to improve patient safety was published in 2013, to prevent operative and post-operative events
based on a review of strategies contained in (Chap. 26) (Text Box 2.1).
Making Health Care Safer, Joint Commission Six of the recommended patient safety strate-
standards, Leapfrog Group strategies [19]. The gies are very germane to the perioperative area,
report identified 22 strategies ready for adoption, namely obtaining informed consent on potential
with a ‘top ten’ list of patient safety strategies that risk of procedure, team training, computerised
were so strongly recommended for adoption that provider order entry, use of surgical outcome
the authors stated that ‘our expert panel believes measurements and report cards, rapid-response
that providers should not delay adopting these systems, use of complementary methods for
practices’. Of the top ten patient safety strategies, detecting adverse events or medical errors to
recommendation number 1 relates specifically to monitor for patient safety problems, simulation
the perioperative area, namely the introduction of exercises, or documentation of patient prefer-
preoperative checklists and anaesthesia checklists ences for life-sustaining treatment.
This list also demonstrates that in order to launched by the WHO and the Health Care
improve surgical safety, a broader view of the Quality Indicator Project led by the Organization
surgical pathway is needed than encompassed for Economic Co-operation and Development
by the activities and actual procedure conducted (OECD). In Europe, the Safety Improvement for
in the operating theatre. Improving safety and
quality in the surgical domain requires actions Table 2.2 Seven key strategies to improve quality and
that go beyond the responsibility of the surgical safety in hospitals (modified from Groene, Kringos,
microsystem where the problem is observed (for Sunol [25])
example the failure to rescue after high-risk sur- Strategy Evidence
gery) [20, 21]. Aligning internal There is mounting evidence
The international DUQuE Consortium con- organisational from close to 100 scientific
ducted the largest collaborative project investigat- processes with studies to suggest that
external pressure undergoing external assessment
ing the effects and impact of quality management improves the organisation of
systems in European hospitals [22]. It formulated work processes, and promotes
and tested hypotheses regarding the implementa- changes and professional
tion of quality management systems, their asso- development
ciations with other factors known to affect quality Putting quality high Simply put, research suggests
on the agenda that hospitals in which leaders
and their effect on quality of care in various care are involved in quality reach
pathways that reflect the diversity of hospital better quality-of-care
operations [23]. In addition, the consortium con- outcomes. Lack of senior
leadership affects patient care
ducted a series of systematic reviews of the key
even where patient care in
strategies to improve quality and safety in hospi- clinical units is pursued by
tals, extracting information on their effectiveness competent and dedicated
and on contextual factors affecting their imple- professionals
mentation [24]. Based on this body of work, seven Implementing Multiple quality systems
supportive operate within any hospital.
key strategies to improve quality and safety were
organisation-wide These quality systems need to
recommended [25] (Table 2.2). systems for quality be well aligned to maximise
Despite the emerging evidence on the impact of improvement impact and minimise
strategies to improve quality and patient safety, unnecessary bureaucracy or
documentation that takes time
questions have been raised why the progress is so
away from patient care
slow, with some studies even suggesting an
Assuring High-quality care cannot be
increasing incidence of patient harm over time [1]. responsibilities and provided without well-trained
According to Shojania and Thomas this is because team expertise at and motivated professionals. A
(a) the identification of interventions to reduce departmental level key strategy to improve the
quality of care is thus the
patient safety problems has been slower (and
recruitment, retention and
many interventions have been less effective) than development of professionals
expected, (b) the patient safety practices demon- with the right competences
strated to be effective (see above) are not suffi- Organising care The majority of hospital
ciently implemented on a wide scale, and (c) the pathways based on departments still follow a
evidence of quality traditional organising principle
measurement of improvement efforts is much and safety according to the medical
harder than the measurement of problems [26, 27]. interventions specialisation. To better
This is demonstrated by the concerted effort to respond to current patient’s
improve patient safety on the one hand, and an needs, an organisation based
on care pathways should be
assessment of the implementation progress in the pursued in which all clinical
hospital setting of the recommended patient activities are centred on the
safety practices. International patient safety patient’s overall journey
efforts include the Global Patient Safety Alliance (continued)
20 O. Groene
Table 2.2 (continued) delivery of optimal care and indicates substantial

Strategy Evidence room for improvement [28].
Implementing Hospital information systems
pathway-oriented (covering computerised clinical
information systems decision support systems in urveillance and Monitoring
S
hospitals, electronic health
records, computer-assisted of Surgical Safety
diagnosis, reminders for
preventive care or disease The capacity of countries and hospitals to assess
management or drug dosing
the amount of harm caused differs substantially. As
and prescribing) have an
enormous potential to improve referred to above, the majority of studies on adverse
quality and safety of events have used the retrospective case record
healthcare. The effectiveness of review. The method has the advantage that assess-
computerised clinical decision
ments are conducted by clinicians with experience
support systems has been
evaluated by more than 300 in the content area, but has shown to have limited
studies inter-rater reliability between clinicians that are
Conducting regular Audit and feedback are key judging whether an adverse event occurred or
assessment and quality improvement strategies, whether harm was preventable. The method is also
providing feedback which can be applied
costly and time consuming and therefore not well
individually or as part of
multifaceted interventions. suited for routine assessments and monitoring.
Audit and feedback have been Various alternative sources exist to assess adverse
well researched in more than events. For example, in England there are about 50
100 studies to support the
National Clinical Audits that prospectively collect
assumption that professionals
improve their performance national level data for a range of conditions that
when feedback demonstrates involve a surgical procedure, such as cancer sur-
deficiencies in process or gery, cardiac surgery or orthopaedic surgery
outcomes of care
replacement. These National Clinical Audits col-
lect data, for example, on complications during
Patients in Europe (SImPatIE) project estab- index hospitalisation, unplanned admission to ICU
lished a common European vocabulary and a set or return to theatre [29]. However, these National
of indicators and internal and external instru- Clinical Audits do not cover the whole spectrum of
ments to improve safety in healthcare. The patient care delivered and they differ significantly
European Network for Patient Safety (EUNetPaS) in terms of methodological robustness, scope and
created an umbrella network of all European reporting mechanisms [30].
Union (EU) member states and stakeholders to Another source of data is hospital administra-
enhance collaboration in the field of patient tive data, which have been used previously to
safety. The joint action on Patient Safety and construct patient safety indicators in the USA
Quality of Care has identified activities and tools and its use in monitoring healthcare quality and
for mutual learning among all EU member states. safety [31]. The quality of administrative data
In an assessment of the implementation of patient has improved a lot in the last decade. It now
safety practices and the evidence-based organisa- includes more clinically relevant data items,
tions of patient care according to the recommen- coding of data have improved and data on a large
dations of the agencies above, they found in a number of patients can be extracted easily, it
large random sample of EU hospitals that neither provides the statistical power for the study of
patient safety practices nor were routinely fol- rare events that other methods might lack.
lowed with a substantial variation in how care In England, Hospital Episode Statistics (HES)
was delivered between departments and hospi- have been used extensively to assess and monitor
tals. This raises serious concerns regarding the patient safety. For example, an assessment of
Hospital Episode Statistics found that about paring outcomes between hospitals, risk adjust-
2.2 % of all hospital admission records contain ment for patient characteristics is crucial because,
one or more of the 41 adverse events or misad- when patient populations differ between hospi-
venture codes that are used to document surgical tals, differences in outcome may represent differ-
or obstetric harm or other complications [32]. ences in baseline risk rather than in quality of
HES data has been used to explore specific mea- care. Insufficient case-mix adjustment can lead to
sures of patient harm based on the patient safety unfair comparisons. This is of particular rele-
indicators developed by the Agency for Health vance where surgery bears substantial risks [36].
Care Research and Quality (AHRQ) and subse- In the UK, an ambitious surgeon reporting pro-
quently adapted internationally [33]. Examples gramme has been implemented in 2015, brought
of patient safety events that can be monitored on by various high-profile scandals about bad-
using this data include catheter-related blood- quality care. Today, surgeon reports are seen as a
stream infections, post-operative DVT and central tool for quality improvement. Since 2013
pulmonary embolism, post-operative sepsis,
individual surgeons’ outcomes are made public
accidental puncture or laceration, or a foreign via NHS choices. Data is published for 5000 con-
body left in the body during a procedure. These sultant surgeons in 12 specialties (adult cardiac
indicators can be computed by using algorithms surgery, bariatric surgery, colorectal surgery,
that combine the coding of primary and second- endocrine and thyroid surgery, head and neck can-
ary diagnoses with a range of procedure codes cer surgery, interventional cardiology, lung can-
[34]. In addition, HES can be used to identify cer, neurosurgery, orthopaedic surgery and upper
possible proxy measures of harm such as emer- gastrointestinal surgery). Data source and mea-
gency readmissions to a hospital after an index sures vary among specialties, but all include mor-
admission for a surgical procedure. An overview tality rates for their patients (Table 2.3).
of British studies suggested that 15.6 % of read- Whether surgeon reports can be an incentive
missions could be avoided, but estimates vary for quality improvement cannot be easily
largely depending on the clinical condition or answered [37]. From a behavioural economics
type of codes considered [35]. perspective, these reports can be seen as a
Importantly, in deciding how to monitor and ‘nudge’ that provides feedback to intrinsically
assess surgical safety, the level of granularity and motivated surgeons, who will then act accord-
the intended purpose need to be clearly specified. ingly and try to improve. Because of the meth-
Levels of granularity include the health system odological limitations of the underlying data it
level, the institutional (hospital) level, the team is also possible that the data causes more harm
level and the individual surgeon level. It is impor- than good, by unnecessarily alerting surgeons
tant to emphasise that an indicator that is valid and the public, or by creating pressures to avoid
and reliable at one of these levels is not neccesar- particular patient groups [38].
ily valid and reliable at another level. This is first In order to support the improvement of qual-
because of the differences in the underlying ity and safety in surgery, a stronger focus
denominators which impact on the signal-to- should be on the upstream determinants of
noise rate and the possibility to reliably detect the safety, or as in Brown’s framework the manage-
event, and secondly, because of differences in the ment processes leading to active error, rather
attribution of this event to an act of omission or than mortality and morbidity outcomes only [6,
commission, resulting from a latent or active 39]. This should include an assessment of the
error. Most patient safety indicators have been implementation of established patient safety
validated at a fairly high level (health systems or practices and a timely monitoring of team based
institution) and are not fit for reporting at the process measures that are clearly linked to
team or surgeon levels. Furthermore, when com- patient outcomes [40].
22
Table 2.3 Clinical example of the data included on surgical report cards
Number of
Procedures included Total cases included consultants Mean procedures/consultant Outcome measure Mean rate
Cardiac surgery Adult cardiac operations Approximately 248 Unclear In-hospital mortality 3.1 %
100,000
Vascular surgery Infrarenal abdominal 21,266 AAA: 15,751 458 AAA: 429 32 AAA: 31 CEA AAA repair: In-hospital 2.2 % (AAA)
aortic aneurysm repair CEA CEA mortality
(AAA) and carotid CEA: 30-Day stroke/ 2.4 % (CEA)
endarterectomy (CE) mortality
Thyroid and Thyroid operations: 13,233 125 Unclear: Approximately In-hospital mortality; 0.1 % In-hospital
endocrine surgery Lobectomy, 91 re-exploration for mortality
isthmusectomy, and total re-bleeding; 1 % Re-exploration for
thyroidectomy readmission rate; re-bleeding
proportion of patients
2 % re-admission
who developed late
hypocalcaemia; length 9 % Hypocalcaemia
of hospital stay (all
first-time
thyroidectomy)
Orthopaedic Hip replacement, and Unclear Unclear 63 Hip: 54 Knee 90-Day mortality 0.6 % Hip replacement
surgery knee replacement 0.4 % Knee
replacement
Urology Nephrectomy 5449 283 14 30-Day mortality; rate <3 %
of post-operative <9 %
complications;
<15 %
transfusion rate; and
length of hospital stay
Upper GI surgery Oesophagectomy or 2381 163 14 (median) 30-Day mortality rate 2 %
gastrectomy with
curative intent
O. Groene
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Concepts and Models of Safety,
Resilience, and Reliability 3
Jonathan Gao and Sidney Dekker
“This place would be a lot safer if I could just get rid of the nurses who make mistakes”
—Nurse Manager
Introduction Normal Accident Theory
Approaches to safety have often considered the With the rapid advancement of technology, many
“human” factor in an organisation or operation as organisations today are complex systems, and
a major contributor to unwanted outcomes. Most these systems interact with an equally (if not
responses to this “problem” involve trying to exert more) complex environment [3, 4]. Complexity
more control over people [1]. This can happen has been argued to render these organisations
through the generation of policies, guidelines, and accident prone in two ways. First, minor failures
prescriptions, and of course the enforcement of between multiple components within a system can
procedures. While these may make intuitive sense interact in incomprehensible or difficult-to-follow
for some, research suggests that such a view may ways to produce a larger failure. Second, the com-
not be valid as an extensive focus on failures cre- plexity of these systems makes it difficult for any
ates the erroneous impression of humans as a one individual to fully comprehend every single
liability, and ignores the many other instances of process involved in keeping the system functional
humans contributing to success and resilience [2]. [4, 5]. Therefore, when an accident occurs, opera-
Not only are people crucial in the creation of tors within the system may find it difficult to rem-
safety in the messy details of everyday work, edy the situation. Most retrospective responses to
there are also an enormous number of other fac- such issues rely on adding more components or
tors (many of which are beyond control of the layers of defences, such as an extra alarm or
human at the sharp end) that are behind the cre- another backup power generator. However, this
ation of success and the occasional failures. only adds to the system’s complexity and might
lead to even more unintended interactions and
consequences. Given that failures involving com-
plex component interactions are unusual and often
unforeseen, they are not considered when we
J. Gao (*) • S. Dekker, M.A., M.Sc., Ph.D. attempt to determine the probability of an accident
School of Humanities, Languages and Social Science, occurring. Therefore, it is likely that the actual
Safety Science Innovation Lab, Griffith University, probability is much higher than we think.
Macrossan Building (N16), 170 Kessels Road,
Brisbane, QLD 4111, Australia Of course, not all organisations or surgical
e-mail: [email protected]; operations may encounter accidents since they
[email protected] are loosely coupled [3]. In such systems, the

26 J. Gao and S. Dekker
continued functioning of a component is rarely blamed for not having anticipated the outcome.
dependent on the functioning of other compo- Third, it assumes that the linear manner in which
nents [3, 6]. For instance, the performance of a the system operates means that it is possible for
medical faculty in a university is rarely depen- one to reverse the linear process to discover the
dent on the performance of the business faculty. cause of an accident. In other words, since C is
This is not the case for tightly coupled systems only caused by B and B is only caused by A, this
such as the operating room, where the function means that A is the source (or root cause) of the
of the surgeon depends greatly on the function problem. Fourth, it assumes that it is possible for
of another component such as the anaesthesiolo- investigators to collect all the information neces-
gist, and thus an issue with one of them is likely sary to form a true story of what exactly happened
to lead to an issue with the other. In turn, other to give rise to the adverse event.
personnel (e.g. nursing and the recovery room However, these assumptions may not be real-
staff) who rely on them will experience disrup- istic, especially in the domain of healthcare and
tion to their work as well. These disruptions and in highly complex surgical microsystems [11].
issues may interact with one another in an There are many examples which indicate that not
unforeseeable manner, causing an accident. In all systems operate purely in a linear manner. For
sum, organisations that operate using systems instance, the performance of a nurse in a hospital
that are both complex and tightly coupled will is potentially influenced by a plethora of factors
likely experience an accident and numerous like the nurse’s case load, whether there is a staff
near misses at some point in time [3, 7]. These shortage, the type of observation charts used, the
accidents are an expected by-product of a com- noise level and lighting within the wards, and
plex and tightly coupled system, and therefore whether the nurse is interrupted [12–16].
seen as “normal”. Hence the term normal acci- Likewise, the performance of a surgeon can be
dent theory. affected by factors such as disruptions, fatigue,
and stress levels [17–19].
Since the healthcare system operates in a com-
Complexity Science plex manner, it stands to reason that the second
assumption of outcomes being predictable is
Some might still argue that accidents are a result likely to be false. A complex system like health-
of human error [8, 9]. This section discusses care is likely to experience a huge amount of
complexity and explains why blaming accidents interactions, some of which are non-linear, among
on human error alone may be a simplistic all of its components [20–22]. These interactions
approach that misses the bigger picture. We will can take a range of forms, such as the interactions
look at the underlying assumptions, and argue between staffs across multiple disciplines or small
why these assumptions may not be realistic, espe- physiological changes within a patient interacting
cially in a medical or surgical setting. to cause major disruptions in the patient’s health.
The perception of accidents as the simple Systems of such complexity mean that it is impos-
product of human error usually contains at least sible for any one individual to fully comprehend
four underlying assumptions. First, it assumes all the tasks necessary to keep it functional [4, 5].
that the system involved solely operates in a lin- Given the complexity and interactivity involved,
ear manner [10]. In other words, A only causes B, outcome prediction is near impossible.
B only causes C, and so on. Second, it assumes Following from the above, the third assump-
that since the system operates in a linear manner, tion is likely to be false as well. Since the health-
it therefore follows that with sufficient knowl- care system is immensely complex and highly
edge, an operator within the system can or should interactive, finding out the factors contributing to
be able to predict the outcome of their actions. an accident is not as easy as simply reconstructing
Therefore, when an adverse event occurs, such as a linear process [10]. Moreover, not all accidents
a wrong-sided surgery, the surgeon is often have a cause, as discovered during the
3 Concepts and Models of Safety, Resilience, and Reliability 27
investigation into the accidental shooting of two accident investigators to determine which behav-
US Black Hawk helicopters by two US fighter iour or decision led to the accident and wonder
jets. This shooting is thought to have happened why the people involved failed to notice the same
due to the many local units each developing their things. In doing so, the challenges that these peo-
own procedures and routines to manage local ple faced are trivialised and the bigger picture,
demands. The development of local procedures that such accidents are mostly the product of
and routines is a normal occurrence, as the origi- complex and interactive systems, is missed.
nal plans do not always suit the local situation. In summary, attributing adverse events to
However, the differences in procedures and rou- human error hinges on the four assumptions
tines among the various units made it difficult for being valid. However, these assumptions are
these units to act smoothly and successfully in a unrealistic in complex and interactive systems
tightly coupled situation, leading to the shooting like healthcare. Rather than looking at accidents
[23, 24]. Lastly, this assumption also depends on using a linear approach, we should perhaps fol-
the accident investigator being given full access low in the footsteps of high-reliability organisa-
and the ability to gather all the necessary informa- tions (see section “Principles of High Reliability”)
tion to reconstruct an accurate picture of the acci- and adopt a systems approach instead, which is
dent. As will be argued below, it is highly unlikely well suited for complex settings such as in surgi-
for that to happen. cal setting. Essentially, this approach takes the
The fourth assumption regarding an investiga- view that an individual failure is a symptom of a
tor being able to gather all the necessary informa- larger problem within the system, which enables
tion to reconstruct an accurate picture of the organisations to learn from their mistakes and
adverse event is likely to be an invalid assump- improve the system [32–34].
tion, for the following reasons. First, systems that It should be noted that such an approach does
are highly complex and interactive tend to con- not mean that humans are entirely blameless, as
tinuously evolve, thereby retarding any attempts there are scenarios in which pursuing individual
at retrospective analysis especially for an out- responsibility might be necessary [35]. However,
sider unfamiliar with the nuance changes in com- most errors are arguably committed by proficient
plex systems [25]. Second, a huge amount of and well-meaning operators who possess a finite
information might be lost or difficult to obtain in capacity (as do all humans) and who face numer-
the course of accident investigations since one’s ous challenges when carrying out their duties
behaviour can be influenced by a multitude of [31, 36]. Thus, the focus here should not be on
factors, such as unwritten routines or subtle oral punishing them, but to examine the means of
or behaviour influences by other supervisors or improving the system in order to alleviate some
staff members [26]. of their difficulties and attenuate future adverse
Third, research has shown that memory is events [32, 36].
unreliable and highly context dependent [27–30].
The way in which a question is phrased has the
capacity to alter answers and memories. afety Drift and Procedural
S
Furthermore, people are also susceptible to incor- Violations
porating misinformation from various sources
into their memory of an accident. Thus, this Safety Drift
might hinder or at least affect attempts at infor-
mation gathering and increase the chance of Healthcare systems are vastly complex and set in
hindsight bias [31]. an environment that is equally (if not more) com-
Lastly, the process of reconstructing a repre- plex [3, 4]. Besides consisting of a multitude of
sentation of an accident is at risk of succumbing individual components (e.g. doctors and nurses,
to the hindsight bias [31]. Given that the outcome technological artefacts, regulatory pressures), sys-
of an accident is already known, it is easy for tems of such complexity also possess subsystems
(e.g. anaesthesiology team, general surgery team) Scarcity and competition refer to an organisa-
that are working to achieve their own goals [31]. tion experiencing a lack of resources, and facing
These goals are not always compatible, however, intense competition [24]. Rasmussen suggested
resulting in conflicts that need managing. Those that a typical organisation has to work within three
involved would have to make decisions based on boundaries, the first being economic, the second
the situation and some of these decisions might being safety, and the third being workload [41].
require the sacrificing/trade-off of safety to Working beyond the economic boundary means
achieve a particular production goal or to live up that the organisation would not be able to maintain
to other duties [37, 38]. Typically, this trade-off itself financially, while crossing the safety bound-
does not yield any immediate negative conse- ary means that the organisation’s operation is
quences [39]. Therefore, those involved would be highly dangerous (e.g. patient’s well-being may
misled into assuming that the trade-off is accept- be endangered). Lastly, exceeding the workload
able and it becomes part of the normal process. boundary means that the people and/or the tech-
When another conflict emerges and another trade- nologies within the organisation are no longer
off is made with no adverse results, this second capable of carrying out their work. As mentioned
trade-off might be once again be assumed to be earlier, organisations generally drift away from
acceptable and becomes part of the normal pro- the safety boundary to satisfy production pressure
cess. This process (known as normalisation of since the loss of safety is rarely felt while the
deviance) will repeat itself, slowly nudging the reaching (or not reaching) of production pressure
system towards greater risks until an adverse is tangible [37].
event takes place. Decrementalism means that an organisation
Despite the risks involved, those within the moves to the edges of the safety boundary over a
system are unlikely to be aware of this drift to series of small steps (instead of instantaneously),
failure as signs are typically only noticed by as it attempts to meet production pressure, as
those outside of the system (e.g. accident investi- explained earlier [24]. This should not be con-
gators) after an accident has occurred [24]. To fused with normalisation of deviance, which refers
those within the system, seemingly poor deci- to trade-offs made in response to abnormal situa-
sions in hindsight are actually rational, given the tions (e.g. high demands) being seen as the new
contemporaneous circumstances [31]. While norm.
seemingly a bad phenomenon, the drift away Sensitivity to initial conditions (otherwise
from safety is not necessarily a negative indicator known as the butterfly effect) essentially argues
of an organisation’s performance [24]. Rather, it that seemingly small factors in a system’s starting
is simply a by-product of a complex system conditions can lead to large failures, as these factors
adapting to the challenges from both within itself interact in novel ways to give birth to unintended
and the environment. The challenge is to ensure consequences, pushing an organisation towards the
that the clinicians involved understand the role edge of the safety boundary [24]. Unruly technol-
and importance of these trade-offs (i.e. clinical ogy refers to the gap that exists between how
sensemaking) [40]. designers of a technology think it will work, and
how the technology actually works when exposed
to the environment [24, 42]. For instance, the intro-
Features of Drift duction of poorly designed health information
technology in some hospitals has been argued to
So what are the elements that contribute to a sys- cause issues such as (a) making it difficult for phy-
tem drifting towards failure? At present, it is the- sicians to gain a proper understanding of a patient’s
orised that at least five factors are involved, condition, and (b) producing reports that lack infor-
namely (a) scarcity and competition, (b) decre- mation value, due to the technology’s insistence of
mentalism, (c) sensitivity to initial conditions, (d) using standard phrases [43].
unruly technology, and (e) contribution of protec- The last factor is the contribution of protec-
tive structure [24]. tive structure, which suggests that the p rotective
structure that was deliberately created to keep safety methods. However as with the above,
the operation safe can end up contributing to a expecting an organisation to reduce production
drift towards failure [24]. One example is a pressure might be wishful thinking. Even if an
safety or governance department that, through organisation chooses to invest in proven safety
its generation of many different layers of methods, it is highly likely that production
defence and guidelines, actually contributes to pressure will follow this increase as staffs would
complexity, thereby rendering real sources of be expected to produce a greater output with the
risk less visible to the sharp end users. same resources (i.e. be more efficient) [37].
In sum, while there has been several sugges-
tions on ways to diminish an organisation’s poten-
ossible Means to Reduce Potential
P tial for drift, these suggestions each come with
for Drift their own caveat. Nevertheless, this does not mean
that it is impossible to reduce an organisation’s
Despite the potential for drift to result in unwanted drift potential since there may be other solutions
consequences, a definitive solution to reduce an that have yet to be explored. For example, Rochlin
organisation’s potential for drift does not appear and his colleagues have observed that the various
to exist. Nonetheless, this section will be devoted subsystems on board a naval aircraft carrier were
to the exploration of some of the ideas in the able to balance multiple constraints and pressures
hopes that some would find it useful. to consistently produce smooth performances [5].
As suggested earlier, signs of drift are not Perhaps an in-depth study on how these subsys-
always obvious to those within the organisation tems co-operate and negotiate with one another
[24]. Therefore, one plausible approach of reduc- might yield some useful information.
ing an organisation’s potential for drift is to study
how decision makers make sense of the informa-
tion environment (e.g. why they take in certain bits Procedural Violations
of information and ignore others) as well as how
they make and rationalise their decisions [44]. As argued earlier, drift is not an indicator of an
However, this may not be a fruitful endeavour organisation’s failing, but a sign of it adapting
since an organisation’s drift into failure is usually [24]. It can appear in many forms, such as proce-
only known after an accident has occurred and any dural violation (also known as workarounds).
knowledge gleaned might be specific to that acci- Workarounds appear to be frowned upon as it
dent and have little applicability in other deviates from rules and regulations, which some
contexts. consider sacred [46]. Such a viewpoint may have
Arguably, a decision maker must pay atten- its merits, for deviations from rules and regula-
tion to multiple sources of information and invite tions have resulted in unwanted results. For
doubt to make the best possible decisions [45]. instance, it was argued that non-compliance with
But this may be an idealistic notion as decision rules and regulations contributed to an incident
makers may be bombarded with an enormous where the wrong patient was given an invasive
amount of information, which would require a procedure.
long time to process, and immense cognitive However, it might be a mistake to assume that
resources [24]. Furthermore, tell-tale signs of all forms of procedural violations are bad. For
drift may be weak or unbelievable, and hence go example, one form of medical guidelines in the
unnoticed [37]. USA specified the use of levofloxacin for
Another potential approach would be to move community-acquired pneumonia [47]. But others
the organisation away from the safety boundary, have suggested that a physician should not always
reducing the likelihood that it will be crossed and follow these guidelines as levofloxacin is an
produce an accident [41]. Examples include reduc- expensive form of antibiotics that not all patients
ing production pressure or investing in proven can afford, and not having antibiotics could lead
to patients’ conditions worsening [48]. To avoid up with a disruption that has occurred. In the
this outcome, physicians need to deviate from the initial phases of decompensation, the system
rules and regulations and prescribe a different and automatically attempts to compensate when a
more affordable form of antibiotics. Furthermore, disruption takes place and is somewhat s uccessful
each patient has their own unique co-morbidities in doing so, hence masking the problem as it
and medical history, making it near impossible to continues to fester. Eventually, the system’s
create a set of guidelines to address each case. adaptive capacity would be drained, causing a
Under such circumstances, physicians should be sudden collapse and failure.
allowed to act as they see fit instead of being The second issue is one that has been dis-
penalised for not complying with procedures. In cussed earlier, namely the possibility of various
other words, procedural violation may not always subsystems having conflicting goals with one
be a bad thing as it captures the local wisdom of another, leading to each subsystem taking actions
the providers. that may benefit them individually but limits the
system’s adaptive capacity [51]. The final possi-
bility is that the system may persist in using out-
tretching the Limits of Adaptive
S dated practices even though the environment has
Capacity changed and despite the introduction of new
practices.
As argued above, healthcare organisations have to Given the importance of adaptive capacity in
adapt to multiple constraints both within itself and ensuring that a surgical system remains func-
the environment [24, 31]. One way of doing so tional, it is therefore necessary to figure out the
would be to stretch its adaptive capacity. Adaptive means of stretching this finite resource to avoid a
capacity refers to a system’s ability to adjust its system failure [52]. One plausible way might be
actions in response to high production pressure, to stay sensitive to indicators that the system is
such as a hospital temporarily using stretchers or silently compensating for disruptions and to take
chairs in the hallways when there are insufficient remedial actions immediately when these indica-
beds to accommodate a sudden spike in demand tors display abnormal signs [51]. However, this
[49, 50]. When a system attempts to adapt itself to might not be an easy task since it requires one to
handle a particular type of disruption, it will inevi- be able to successfully differentiate between
tably become less adept at handling other types of good adaptive behaviours (e.g. workarounds to
disruptions [51]. When these other disruptions increase efficiency) and bad adaptive behaviours
actually happen, the system’s adaptive capacity (disruptive behaviours that indicate that the sys-
will be tested and failure is a real possibility. Since tem is on the path to failure).
failure is an unwelcome result, it is therefore
important for a system to know where it stands in
terms of its adaptive capacity, the type of prob- Resilience
lems that can arise in an adaptive system, and the
means of stretching this finite resource if neces- A second means of dealing with constraints and
sary [52]. For a system to figure out where it complexities would be to apply the principles of
stands in terms of adaptive capacity, it should pos- resilience engineering. Resilience is defined as
sess at least the following three characteristics: the ability of a system to adapt its functioning
(a) capacity to reflect on how well it has adapted, prior to, during, or following any changes or
(b) awareness to know what it is adapting to, and disruptions to sustain regular operations under
(c) changes within its environment [51]. all conditions [53]. The key term in the defini-
There are three potential ways by which an tion is adapt, meaning that resilience is about
adaptive system can break down [51]. The first is the system’s ability to adjust its functioning to
decompensation, which essentially refers to a meet challenges. A system that is able to sustain
system’s adaptive capacity being unable to keep regular operations under all conditions is not
necessarily resilient, since this can be easily In terms of developing a set of responses, the
achieved via inefficient means such as stockpiling system needs to be able to verify its effectiveness
an absurdly large amount of resources (e.g. hav- as well as consider appropriate means of main-
ing multiple empty wards in a hospital in case of taining such responses [53]. As mentioned above,
an emergency). Hence, adaptation is important. having an absurdly large amount of excess
However, some form of excess resources may resources (e.g. dozens of empty beds) might be
still be necessary for the system to draw upon in an effective response, but it is certainly not effi-
times of need, meaning that not all excess cient and is costly to maintain in the long run.
resources should be removed under the pretext of For a system to have the capacity to monitor
efficiency [52]. Therefore, one possible problem ongoing developments, a list of valid and reli-
with resilience engineering would be the difficulty able indicators needs to be developed and con-
in determining whether a set of spare resources tinuously monitored [53], in other words, an
should be removed for efficiency or retained to organisational dashboard of indicators that can
achieve resilience. Whether a system can success- consistently yield useful information. An exam-
fully manage this is likely to depend on how it ple of a poor indicator would be the number of
implements and sustains the four pillars of resil- human errors committed, since it depends on
ience. For example, if a system is proficient in pre- unrealistic assumptions and misses the bigger
dicting future threats (one of the four essential picture, as argued earlier.
pillars of resilience), it should be able to deter- Additionally, these indicators are unlikely to
mine if the extra resources available would be use- always remain relevant, and thus should be con-
ful in helping it achieve resilience by allowing it to stantly revised and updated [53]. A clear set of
better meet challenges, or if the extra resources guidelines is necessary to guide this revision pro-
are a hindrance as it prevents the system from cess as the typical approach is to simply revise
operating efficiently. the indicators after an accident has occurred.
Such an approach is inadvisable because of two
reasons, namely (a) it holds the unrealistic expec-
Four Pillars of Resilience tation that indicators should be able to predict all
adverse events, which is unlikely to happen due
Given the apparent benefits of resilience (i.e. able to complexity, and (b) revisions based on this
to handle disruptions), healthcare systems might approach usually do not yield effective solutions
consider adopting at least some of its principles. due to a heavy focus on face validity. Aside from
Currently, it is argued that a resilient system the above, the development of suitable monitor-
should possess four key abilities, namely (a) the ing indicators requires the consideration of other
ability to respond to disruptions, (b) the ability to factors as well, such as the predictive value of the
monitor ongoing developments, (c) the ability to indicators, the means by which the indicators are
predict potential threats and opportunities, and measured, and whether the information provided
(d) being able to learn from both failures and suc- by the indicators refer to temporary or permanent
cess [54]. events.
For a system to be able to respond to disrup- To determine if a system is capable of predict-
tions, it should come up with a list of potentially ing both potential threats and opportunities, the
disruptive events and develop a set of possible assumptions that it holds about the future should
responses to these events, so that it may react be examined [53]. If a system perceives the future
appropriately in a timely manner when the dis- to be a replication of the past, or that past events
ruption occurs [53]. For the list to be effective, the can be used to deduce future events, then the sys-
disruptive events that are being included should tem is unlikely to possess the ability to predict
be rigorously examined on a frequent basis to potential threats or opportunities as the past may
ensure their relevance and timeliness. not always be a good indicator of the future [53, 55].
If a system perceives future events to be a phe- Principles of High Reliability

nomenon caused by the complexity and interac-
tions both within itself and the environment, then oncept and Characteristics of High
C
it might be able to successfully predict potential Reliability
threats and opportunities.
Lastly, a resilient system might display the Despite the problems mentioned above, some
willingness to learn from both failures and suc- complex and tightly coupled organisations have
cesses, since both types of events arguably share been able to defy the odds and limit failures, yet
the same underlying processes save for the recov- consistently produce high performance [5]. Such
ery from failure [53]. Academics studying resil- organisations are said to possess high reliability.
ience have argued for the importance of studying In an attempt to understand how these organisa-
success as it provides useful information for the tions managed such a feat, different groups of
occurrence of failures, the rationale being that researchers have studied these organisations and
there are no magical processes that only mani- identified different sets of characteristics which
fests themselves when an accident happens, but they believe might be the key. The lists that these
otherwise remain dormant [54, 56]. Instead, if an researchers came up with share several similari-
accident happens, it is likely that the underlying ties, but possess some differences as well. There
causes have been around for a while and are only fore, this section will first discuss the common
made obvious by the accident. Furthermore, characteristics before looking at the differences
understanding how success happens and invest- observed.
ing in it can not only reduce the possibility of
things going wrong, but can potentially increase
productivity as well. For a system to truly be ommon Characteristics of High
C
resilient, all four components are thought to be Reliability
essential. However, the importance of each com-
ponent in a particular system generally depends The first characteristic of high-reliability organ-
on the system in question and is highly context isation is their proactive approach towards risk
dependent. management. Rather than aiming to prevent fail-
ures, which would be an impossible enterprise,
these organisations choose to make allowances
Limitations of Resilience within their systems for them [33, 34, 57].
Additionally, they obsess over failures and regard
Despite the positive sides to resilience engineer- them as symptoms of a larger problem within the
ing, it still possesses some limitations which organisation. As such, personnel are encouraged
could mitigate its effectiveness. Many of its rec- to (a) report errors (and are rewarded for doing
ommendations are vague and thus hinder attempts so), (b) learn from near misses, (c) avoid being
at implementing them. For example, it recom- overconfident, and (d) be aware of the potential
mends that a resilient system should develop both for small failures to interact and produce an expo-
a list of plausible disruptive events and a set of nentially larger failure.
responses to these disruptions [53]. However, it The second characteristic of high-reliability
may not always be clear as to which events should organisation is their appreciation of the complex-
be included on the list, and which events should ity involved in the daily operations of the organ-
be excluded. isation, and knowing that they can never fully
Moreover, as a system seeks to improve its per- comprehend it [33, 34]. Therefore, they do not
formance in dealing with a particular set of disrup- become overconfident but instead continue to
tive events, it will inevitably experience some form remain hyper-vigilant for possible disruptions.
of setback in dealing with other types of events Furthermore, they understand that the system’s
[51]. Therefore, when these other types of events complexity means that it is impossible for a sin-
do happen, failure becomes a real possibility. gle individual to fully master every single task
needed to keep the organisation operational [5]. required to adapt to changing circumstances on a
Therefore, tasks are broken down into smaller frequent basis in order for the organisation to oper-
tasks, with a specific group attending to each ate safely. Conversely, those who work at the back
smaller task. end are typically temporally and spatially removed
The third characteristic of high-reliability from the front line and hence have a limited under-
organisation is their deference to experts instead standing of what is actually happening at the sharp
of authority [5, 34]. In this case, experts do not end [4]. High-reliability organisations are aware of
refer to those with the most experience, as experi- this and therefore attempt to be sensitive to the
ence may not always be the best indicator of needs of the front line to close this gap.
expertise. Instead, expert here refers to the person
who has the specific set of knowledge needed to
respond appropriately to the situation at hand, Limitations
regardless of the person’s authority [58].
While the works on high-reliability organisations
have produced fascinating and useful informa-
Different Characteristics tion that all organisations can apply, they are not
without flaws. A common criticism of studies on
As mentioned in the introduction to this section, high-reliability organisations is that they have
some differences exist between the two lists of been focusing mainly on unique organisations
characteristics of a high-reliability organisation. like the Navy or air traffic control, and hence the
By differences, we mean that one group of aca- applicability of principles gleaned from these
demics have proposed a particular characteristic organisations to other settings remains to be seen
(e.g. continuous learning) as a contributing factor [59, 60]. Furthermore, these unique organisations
to high reliability, while another group of aca- often do not face production pressure unlike
demics have not. other organisations in domains like healthcare,
The first characteristic is the habit of continu- where medical staff have to attend to a large num-
ous learning. While on board an aircraft carrier, ber of patients in a small amount of time and
Rochlin and colleagues observed that personnel where technology continues to curb their auton-
of high-reliability organisations are continuously omy [61]. Hence, it may be unrealistic to expect
learning, with new methods of work constantly organisations with these constraints to achieve
being introduced, and conventional means always high reliability [62].
being scrutinised for flaws [5]. However, this Such concerns are certainly valid, and while a
does not mean that procedures are always chang- few studies have displayed some level of success in
ing. Rather, new methods are only accepted after applying high-reliability principles in a healthcare
its benefits are proven. setting, many questions remain unanswered and
The second characteristic is constant commu- hence additional empirical research is necessary
nication among personnel, even when there is a [63–65]. For example, Madsen and his colleagues
lull in activities [33]. Such behaviours not only found that although their implementation of high-
keep communication channels open and help reliability principles improved the performance of
everyone to stay updated, but they also permit trust a paediatric intensive care unit, medical staff from
to grow and experienced members of the team to other departments resisted the change. Furthermore,
spot signs that might indicate potential trouble. these improvements were abandoned when the
The third and final characteristic is the display implementers left the unit. Therefore, further
of sensitivity to the needs and requirements of those research could examine the optimal means of
working at the front line [34]. As stated above, introducing high-reliability principles with mini-
healthcare organisations today operate under incred mal resistance, as well as looking at ways of ensur-
ibly complex and regulatory situations, meaning ing that these principles are sustained in the long
those at the front line of the organisation are run. This means addressing the barriers to culture
and organisational change that can get in the way the microsystems are the building blocks of a
of moving towards higher reliability of care [66]. system and thus any attempts at improving the
Besides facing different challenges (e.g. pro- healthcare system to cope with the multitude of
duction pressure), high-reliability organisations constraints should begin at this micro level [70].
and normal organisations may also differ in other
ways, which could make the application of high-
reliability principles difficult. One instance would haracteristics of Surgical
C
be personnel selection. Given the stringent nature Microsystems
of the recruitment practices used by air traffic
control and the Navy, it is plausible that the per- Sanchez and Barach suggest that a good surgical
sonnel within these organisations are not repre- microsystem should possess the following prin-
sentative of the personnel that one might find in a ciples, some of which are similar to the principles
typical organisation [67, 68]. of high reliability [65]. First, there should be an
Also, a study in Germany discovered that indi- acknowledgement of the fallibility of humans,
viduals low in agreeableness, neuroticism, and and the acceptance of accident (or errors) as nor-
openness to experiences were more likely to mal. Instead of pursuing individual responsibility
choose military service over community service when something goes wrong, it should focus on
[69]. This might mean that individuals with par- the complex systemic factors behind the incident.
ticular personality traits are more likely to join the Second, a good microsystem needs to possess
Navy, and these traits in turn make it easier for the chronic unease, a state where an individual (or in
Navy to achieve high reliability. This is purely this case, a microsystem) is concerned that poten-
conjuncture, given that the study was conducted in tial risks are not being properly managed [65,
Germany, whereas the studies on high reliability 72]. It has been suggested that such an unease is
in the Navy were carried out in the USA. Extensive useful as it keeps people alert to possible dangers
empirical studies are needed to determine if there and reduces the potential for complacency. Third,
is any truth to the speculation. it is essential that communication channels
remain open and dissenting views are not swept
aside. Additionally, workers should be provided
Surgical Microsystems with proven tools that can help reduce the poten-
tial for errors. One example might be the redesign
Aside from the teachings of high reliability, the and usage of clinical charts that were specially
idea of surgical microsystems has been touted as designed to be user friendly using applied human
another possible contender for those seeking to factor principles [73].
manage the various constraints in the domain of Fourth, the reporting of errors and near misses
healthcare while maintaining a high level of per- should be encouraged, and the learning value of
formance [65, 70]. According to Sanchez and near misses needs to be appreciated [65]. Fifth,
Barach, the concept of microsystems originated patients should not be excluded from communi-
from Quinn’s works regarding intelligent enter- cation channels and in face communication needs
prises [65, 71]. In the domain of healthcare, a to be designed around the needs of the patient
microsystem refers to a small group of individu- care with the focus on co-producing exceptional
als delivering a service to a particular group of outcomes with the patients [74]. In other words,
patients for a certain purpose. For example, a sur- when a patient is erroneously exposed to danger,
gical ICU can be considered as a microsystem as a good surgical microsystem should pay atten-
it is made up of a group of people (e.g. healthcare tion to the patient’s side of the story in order to
practitioners and the patients’ family) working gain a better understanding and learn from this
together to care for the patient with the goal of safety breach. Lastly, effective microsystems
helping the patient recuperate. It is proposed that need to base their system on proven human factor
principles to optimise performance, support staff 7. Barach PR, Small SD. Reporting and preventing med-
ical mishaps: lessons from non-medical near miss
engagement, and attenuate impact of errors and
reporting systems. Br Med J. 2000;320:759–63.
other constraints such as providing nurses with 8. Levitt P. When medical errors kill: American hospitals
user-friendly clinical charts [65, 73, 75, 76]. have embraced a systems solution that doesn’t solve the
problem. Los Angel. Times [Internet]. Los Angeles;
2014. http://articles.latimes.com/2014/mar/15/opinion/
la-oe-levitt-doctors-hospital-errors-20140316.
Conclusions 9. Topham G. Railway accidents happen because someone
makes a mistake. The Guardian [Internet]. London; 2013.
Rapid technological advancement has led to http://www.theguardian.com/uk-news/2013/jul/25/
railway-accidents-human-error-warning-systems.
organisations becoming complex systems and
10. Dekker S, Cilliers P, Hofmeyr J-H. The complexity of
dealing with a complex environment, making failure: implications of complexity theory for safety
accidents a normal part of operations [3, 4]. investigations. Saf Sci. 2011;49:939–45.
Arguments that these accidents are caused by 11. Mohr JJ, Barach PR, Cravero JP, Blike GT, Godfrey
MM, Batalden PB, et al. Microsystems in health care:
human errors hinge on several unrealistic
part 6. Designing patient safety into the microsystem.
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complexity creates multiple challenges and con- ‘OBS’ chart: an evidence based approach to re-design
of the patient observation chart in a district general
straints for both the system and its subsystems,
hospital setting. Postgrad Med J. 2005;81:663–6.
which forces them to adapt in ways that could 13. Ebright PR, Patterson ES, Chalko BA, Render
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adaptive capacity, attempt to become more resil-
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16. Westbrook JI, Woods A, Rob MI, Dunsmuir WTM,
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Surgery Through a Human Factors
and Ergonomics Lens 4
Ken Catchpole
“Formal accident investigations usually start with an assumption that the operator must
have failed, and if this attribution can be made, that is the end of serious inquiry. Finding
that faulty designs were responsible would entail enormous shutdown and retrofitting
costs; finding that management was responsible would threaten those in charge, but
finding that operators were responsible preserves the system, with some soporific
injunctions about better training.”
—Charles Perrow, 1984, p. 146
[2], combined with understanding of human psy-

Introduction chology, physiology, anthropometry, and biome-
chanics among a range of other disciplines which
Human factors engineering (HFE) is the science emerged in the twentieth century. HFE became a
and practice of understanding and improving the discipline of its own in the 1940s, at a time when
relationship between people and things. It should aircraft were becoming exponentially more com-
generally be considered synonymous with ergo- plicated, and sequences of studies demonstrated
nomics, though there may be subtle differences a range of mismatches between human percep-
in the use of the terms. HFE is based on the prem- tual and cognitive abilities, and what they were
ise of designing work to human abilities, in con- being required to do. It emerged that human
trast to the more traditional concept of adapting errors were predisposed to designs that required
humans (via training) to work requirements. In a human operation and intervention, but did not
complex system, both may be required. The account for their limitations. For example, on
premise of HFE is that training alone is expen- some aircraft the gear and flap levers were located
sive, time consuming, unreliable, and cannot close to each other, and felt the same in the pilot’s
overcome many barriers to performance, and that hand, which made it easy to confuse them [3, 4].
instead we can leverage a knowledge of how The time and visual demands of the tasks in
humans naturalistically understand and respond which they were being used (takeoff and landing)
to the world to enhance their ability to reach meant that pilots used touch to activate them,
goals. Thus, training in conjunction with the with a mistake being recognizable only after the
design of tasks, technologies, and environment to aircraft had subsequently entered a risky state.
support human abilities is more likely to be suc- The solution was to change the shape and feel of
cessful than just training alone. the levers so they could not easily be confused.
The discipline has its origins in the scientific These concepts were extended in the 1950s and
management principles of Gilbreth [1] and Taylor 1960s to the understanding of accidents such as
Three Mile Island, and in the increasing mis-
K. Catchpole, BSc, PhD (*) matches between what humans were required to
Department of Anesthesia and Perioperative do in increasingly complex technological sys-
Medicine, Medical University of South Carolina,
tems, and their abilities to do them [5]. It was
Storm Eye Building, 167 Ashley Avenue, Suite 301,
Charleston, SC 29403, USA recognized that accidents were happening not
e-mail: [email protected] because people were fallible and technologies

40 K. Catchpole
were not, but that failures happened where tech- reducing the need for training, while increasing
nological weaknesses amplified human weak- ease and pleasure of use, even with products that
ness, and vice versa [6, 7]. were otherwise technically inferior. The difference
Acknowledging that systems of work were a was that anyone could use them.
combination of humans, technologies, processes, These examples demonstrate some of the prin-
policies, management, and training became known ciples that HFE science and practice seek to
as socio-technical systems theory. In particular, the spread. All systems require people; and in every
implication was that when things go wrong, to look system, there will be fallible users prone to errors,
only at human failures is to ignore the complexity of whose performance is shaped by things beyond
those accidents, and thus ignore a range of potential their control (and often beyond their awareness
areas for improvement. One core principle of HFE or conception). Yet, it is people who create safety
is to understand and reduce the mismatch between in complex systems by accounting for variations
human and system, and thus, through this socio- that systems designers cannot appreciate [8]. It is
technical understanding, provide more highly func- thus technological systems that are fundamen-
tioning overall performance. tally fallible, and humans the “elastic glue” that
A more modern example of how the under- holds the system together (or the “vehicle sus-
standing of human cognitive process can shape pension” that smooths over the unpredictable and
designs that reduce errors and the need for training, uneven “road” surface) [9]. As our systems of
while nearly invisibly enhancing performance, work become more complex, opportunities for
ability, and satisfaction, is found in windows, icons, mismatches between human abilities and work
menus, pointers (WIMPS) interfaces, upon which demands increase, and the more important HFE
our interactions with personal computers are now becomes. Healthcare systems are no different. In
based. These “direct manipulation” concepts were the next section we explore some of the most
first developed at Xerox-PARC in Palo Alto in the popular and influential HFE concepts in more
early 1970s, and were leveraged by Apple for their detail.
first Macintosh computers a decade later, as a
response to the existing DOS-based command-line
interfaces that were opaque, required expert knowl- Humans and Automation
edge of computer functions, and did not facilitate
human conceptual understanding of natural human There is no question that the increasing complex-
interaction mechanisms. Thenceforth, the idea of ity and sophistication of machines can enhance
“desktops,” “files,” “worksheets,” and “trashcans” human abilities and system performance.
was developed to mimic the office concepts that Machines can do repetitive tasks faster, more reli-
novice users would immediately recognize, and ably, and with more force, and precision, day-in
could directly interact with without needing to day-out than humans generally can. Latterly, they
understand precisely how the computer worked. can process more information in more complex
This opened the use of personal computing to the ways using sophisticated algorithms that humans
general population, which previously had been the are capable of. Yet, at some point, these techno-
preserve of enthusiasts and engineers. The more logical systems need attention and management
recent extension of this has been in touch-screen by humans. They can break down, are inflexible,
interfaces on mobile and tablet devices that add work reliably only within the parameters for
familiar gestures (pointing, pinching, swiping) to which they have designed, and can demonstrate
allow more naturalistic interactions immediately, huge deviations from acceptable performance
flawlessly, and without needing to use or under- when their data inputs become unreliable or cor-
stand menu or icon selections. Once again, moving rupted. Conversely, humans have evolved to work
from an unnatural method of interaction to a more in highly varying circumstances, can still make
natural one Apple (and to a lesser extent Nintendo effective decisions despite uncertainty or lack of
with their Wii games console) reduced the need for data, and can trade speed for accuracy (or vice
a conceptual understanding of an interface, thus versa) at a moment’s notice. In fact, designers
4 Surgery Through a Human Factors and Ergonomics Lens 41
seeking to mimic human activities—such as presumably, in the absence of visual cues at

developing machine vision—have quickly rec- night, over the sea, in adherence to the pilots’
ognized how complex the adaptations and heuristic of “staying high and fast.” However,
judgments that humans are able to make about this caused the aircraft to stall, which sounded a
their environment must be, given the complexity stall warning. As the aircraft slowed, the stall
of the world around them. The way humans inter- warning then stopped automatically, as it was
act with the naturally unpredictable and chaotic programmed to do, when airspeed dropped
world around them is deceptively complex and it below a minimum. This created confusion, as it
is a strength that humans are not purely informa- would then sound again when the pilot pushed
tion processors [9]. These different strengths of the stick forward (which will usually take an
humans and machines—and how we can design aircraft out of a stall). In the absence of reliable
ways for them to work together the best—have speed information, this created further confu-
been of interest in HFE for 50 years. sion. The pilots then became uncertain about
The initial approach to human-machine inte- which instruments to trust, and appeared to uti-
gration was to automate tasks that machines could lize the flight director (one of the main guidance
do, and let the humans do the rest (“take up the displays) even though it was reading incorrectly.
slack”). The approach, pioneered famously by The problem of freezing pitot tubes was known,
Fitts [10], was to produce lists of functions (“Fitts with nine incidents in the previous year, and the
Lists”) that machines should do, and functions that aircraft in question was due to have them
humans should do. However, this had a number of replaced on return to Paris. However, the pilots
disadvantages. In particular, systems designed may not have been aware of this potential threat
around these principles relegated previously [12]. The confusion was never resolved, and the
skilled humans to “passive monitors,” supervising aircraft hit the sea, killing all on board.
the machines and waiting for things to go wrong The idea that “replacing” the human, who is
[11]. When the machines inevitably did go wrong, seen as weak and fallible and only there to support
control was quickly passed to the human who was the technology, has given way to a different phi-
already conceptually and actively distant from the losophy, which recognizes that humans are essen-
situation, and not necessarily at full awareness tial—and indeed create safety in complex systems.
(since passive monitoring is not a task that humans This creates the opportunity for a different
are naturally good at). They were suddenly con- approach, to support humans with automation
fronted with a cascade of complex events and sys- (and not the other way around). Humans should
tem breakdowns beyond their comprehension, stay in control, actively monitor the systems of
with important information either hidden or not work, and be directly involved in delivery by
easy to discern among a huge number of displays, selecting or deselecting automated systems
alarms, warnings, and other environmental cues, according to their experience and knowledge of
and without a mental model of what was happen- the complex components of the tasks which
ing [9]. This set up the human to make bad deci- machines are not engineered for. This allows the
sions and accidents resulted. This can still be seen humans in the system to manage their skills and
in accidents today, such as Air France Flight 447. experience better, and successfully create flexibil-
On the 1st June 2009, an Air France Airbus ity and resilience, while also taking advantage of
A330 flight 447 from Rio de Janeiro to Paris a range of reliable automatic assistive functions.
experienced a high-altitude stall and crashed This is seen on most modern aircraft (for exam-
into the South Atlantic. The event was triggered ple, where an autopilot can make fuel use more
when a pitot tube (which measures airspeed) efficient), software (such as spelling and grammar
froze over and malfunctioned. This caused the checking), and more recently many driving aids
autopilot to disconnect, though the cause of the and automated driving solutions. The mixed suc-
disconnection (conflicting airspeed readings) cess of these approaches means that there is still
was not displayed prominently. The pilot in con- much work to do to understand how best to help
trol pulled back on the stick to raise the nose and humans and machines to work together. These
42 K. Catchpole
surprising and perhaps counterintuitive effects of Human Factors in Device Design

socio-technical systems [13] have generated a
number of themes, collectively referred to as “iro- A resident attending a crash call was the first to
nies of automation,” such as the following [14]: arrive at the bedside. Treatment was started,
and the resident, working closely with a nurse,
• Automation does not simply “replace” decided that IV access was needed. Knowing
humans—instead it transforms work, and cre- that the crash cart contained a intraosseous
ates new roles for people. injection device, the resident asked for this from
• Automation does not always free up mental the nurse. This technique for rapidly obtaining a
resources and attention—instead it can create route for IV drugs is based on a spring-loaded
new mental demands, especially in busy, criti- needle that is fired into the bone from a tube
cal, or time-pressured moments—and usually about 2″ wide and 6″ long. To activate, it is
requires the operator to monitor the technol- placed onto the skin and the tube pressed for-
ogy in addition to the task. ward by the thumb or palm of the hand. The tube
• Instead of requiring less knowledge, it requires is symmetrical with an arrow directing the user
different knowledge and a new set of skills, towards the needle end of the device. The nurse
often in addition to the existing skills (which unwrapped the device, and handed it to the resi-
need to be actively maintained to avoid fading dent. However, as the patient was a below-knee
of those skills). amputee, the resident needed to take more care
• Instead of providing flexibility, automation to locate the appropriate place for the injection.
creates a wealth of new modes and functions He put down the device, found the right loca-
that need to be understood and that require tion, picked it up again, and fired it.
new opportunities for omissions, failures, Unfortunately, in the time pressure, uncertainty,
errors, and misunderstandings. and novelty of the situation, he had unknowingly
• Rather than necessarily increasing safety, the reversed the device, which was now in the wrong
introduction of new technology must pay for direction. The needle went into his hand.
itself by doing things faster and more cheaply Designs can predispose to errors, or can guide
than before, which can place new throughput users towards the right methods and modes of
and economic demands on other, equally operation [19]. The wrong buttons in the wrong
weak, parts of the system. place, displays that are unclear, labels that are
ambiguous, or devices that allow unsafe configu-
Many of these issues have been uncovered in rations can all contribute to an error. In the above
infusion pumps [15], electronic health records example, if this device had been asymmetric or
[16], laparoscopic surgery [17], surgical robots felt different in the resident’s hand the error could
[18], and a range of other clinical and nonclini- have been prevented. For example, similar bone
cal contexts. In essence, we have learned that injection devices have a pistol grip, where the
discussions which focus on replacing the human direction is immediately apparent to the user—
with technology, usually underestimate the who may not have time or be too distracted to
extent and value of human contributions to per- look. Similar to the flaps and gear levers on
formance and safety, and will likely create a 1940s’ aircraft, this resident was set up to fail by
range of new problems. However, if we approach design. Fortunately they were not seriously hurt,
automation design from the point of view of but could no longer lead the crash call, delaying
helping the human to achieve their goals, by treatment initially, but eventually without an
supporting adaptive human sensemaking and obvious effect on outcome. In healthcare, which
decision making within a complex system, we is much more complex than aviation, where inci-
stand a greater chance of avoiding catastrophes dents are much more numerous, and without reli-
and creating success. able objective accident analysis metrics, these
Fig. 4.1 The technology acceptance model [20]
error-inducing designs in healthcare frequently • Design for the user population: The device
go unnoticed. should be designed for a carefully identified
When we think about technology, we usually group of users (not just “experts” or “opinion
think in terms of what it can do (the functional- leaders”). They should be involved at every
ity), rather than what people need to do to make stage of the design process (including concep-
it work (the usability). However, the functional- tion), with testing conducted throughout with a
ity of a device (i.e., what it can do) is only as chosen sample of those anticipated users. One
good as the usability (how we can do it). A good in ten users will be color-blind. Older users may
rule of thumb is that the more functionality a not have the digital dexterity of younger users.
device has the less usable it becomes, but a device • Designs should be adapted to users, not users to
with limited functionality can still be limited by designs. Relying on training, memory, warnings,
poor usability. In effect, usability is always or instructions as a solution to a design problem
important, but dramatically increases as a device is weak, expensive, and error inducing.
becomes more complex. This complex interplay • Affordances: Designs should reflect intended
between functionality and usability also helps to use. For example, a handle on a door that you
consider acceptability—the likelihood that a pull, or a push-plate on a door that you push.
device will be adopted and used. The device must • Consistency: The way users interact with
also be used appropriately, be reliable, fit into devices should, as far as possible, not vary
normal working practices, be accessible and when using similar functions. For example,
understandable, inform decision making, and changing between numeric keypads with “tele-
lead to demonstrably better performance. In 2016 phone” type and “calculator” type will predis-
the FDA released new guidance for the consider- pose a keying error.
ation of HFE in the design and testing of medical • Redundancy: There should be multiple failure
devices [21], which requires the human to be avoidance mechanisms built in. For example,
considered—and users tested—from early con- to make a clear distinction on an important
cept stages to final evaluation. However, HFE is dimension, the color, look, and feel should all
rarely considered in local procurement practices, be different.
and the FDA guidance cannot account wholly for • Control and display compatibility: How you
the complexity of work. The technology accep- change something on a device should reflect
tance model (TAM) [20, 22] illustrates this rela- how it is being changed in the real world.
tionship between ease of use and perceptions of • Functional grouping: Similar functions, dis-
utility (see Fig. 4.1). plays, and switches regularly used together
The key themes in human-centered design are should be located together. Some anesthetic
the following: machines have the power switch located closer
44 K. Catchpole
to the suction container than the suction power • Level 1 SA: Noticing (“What?”): This is the
switch. This predisposes to errors. basic perceptual level of SA where important
• Understand contexts of use: Where the elements in the environment become salient to
device is used needs to be considered within the observer/operator via the basic senses.
a design. The environment, the physical They might register a change in blood pres-
space, interactions with other devices, peo- sure, or a distinctive smell, a vibration or a
ple, or tasks all affect usability. If an item is touch, or the presence of absence of a sound.
to be used while gloved, this may reduce tac- Without awareness of these stimuli, the next
tile cues. level of SA cannot be reached.
• Procurement: The people who purchase • Level 2 SA: Understanding (“So what?”): This
devices for an organization should be the peo- is the interpretative stage, where the operator
ple using them. For many high-cost purchases, applies meaning to the data they have become
user trials would be highly beneficial and cost aware of in stage 1. It is one thing to recognize
effective. a change in the environment, and another to
know what it means for the task at hand.
Technical training is often focused at this stage.
Cognition in Context In air combat, knowing what speed you are at
combined with the optimal turning speed for
Humans make decisions within a broad systems your aircraft helps you to understand how close
context, and problems with decision making to an optimal turning state your aircraft is cur-
are more common than errors in technical skill rently in. In healthcare, for example, this would
[23]. Cognition within work contexts and how be understanding the hemodynamic implica-
it leads to decision making have been of exten- tions of different arterial pressure locations and
sive interest in HFE and applied psychology measurements.
research. Traditional clinical decision making • Level 3 SA: Projecting (“Now what?”): The
tends to focus on which decision from several highest form of SA is being able to predict
is best, often based on comparative evidence- future states of the system you are working in.
based studies. In contrast, HFE focuses on the Noticing and understanding what is happen-
mental processes by which an understanding is ing, and applying your previous expertise to
reached and how a decision is made. It is often make predictions about what will happen next,
focused on process decisions—how we set enable the human to respond in the most
goals and reach them, or how we navigate a appropriate way to move closer to the desired
patient through the complex sequence of care goal. In the original air combat scenario, think-
required to deliver the appropriate care. In this ing ahead allowed the pilot to avoid getting
section we consider three different but domi- into low-energy states that an enemy could
nant paradigms of relevance, situational aware- take advantage of, and instead allowed the
ness, naturalistic decision making, and pilot to move into a firing solution position. In
distributed cognition. cardiac surgery, understanding the trajectory
Of the three paradigms in this chapter, situa- of a patient’s vital signs, and responding early
tional awareness (SA) [24, 25] is perhaps the sim- if the predicted outcome is undesirable, yields
plest to understand. As with much HFE work, SA safer, more responsive care. Projecting is the
research stems from aviation research, where situ- most challenging level of SA.
ational awareness was considered to be a deciding
factor in air combat success. Subsequent studies The more expertise you have, the better able you
arrived at three levels of perceptual and cognitive are to rise up through the levels of SA; while the
processing that can be considered in most higher your workload, the more distractions there
dynamic, rapidly changing high-technology tasks. are, or the more unpredictable or complex the situ-
The three levels are the following: ation is, the more cognition will reside in the lower
levels. The less able we are to project into the tion is presented clearly and understood by some-
future, the more likely we are to arrive at a point one with enough expertise and who has been
that is undesirable, unsafe, or even more error involved in the task long enough to predict what
inducing. This is why experienced pilots may tell is going to happen next and account for it.
you that they will always anticipate where their In situations where the goals, and ways to
aircraft will be in the future, and never aim to fly in achieve them, may not be as straightforward, the
a reactionary way—which means that they can naturalistic decision-making paradigm [27] can
plan more effectively, and will stay out of serious be useful. It helps us understand how human deci-
trouble. When they can no longer do this, they sion making is mediated by technological, organi-
know that they are in a risky situation. zational, and environmental contexts in greater
A simple example of how the three levels of SA uncertainty, and less dynamic or fluid situations.
interact can be found in driving. Imagine you are It has been extremely influential in the science of
driving along a highway and slower moving traffic applied cognition, especially in military opera-
is merging from an on ramp. You see a car on the tions [28], although it has not been widely applied
on ramp moving slower than you (Noticing/Level in healthcare. Decisions are not necessarily logi-
1 SA). You understand that this means that there is cal, linear, and evidence based. Instead, they are
a risk of collision and that you may need to make based on a wider view of multiple patients, exper-
a decision to alter your course (Understanding/ tise, systems complexity, behavioral intention,
Level 2 SA). You recognize that your car and the individual beliefs, and current understanding of
merging car will arrive at about the same time at the system. This research has led to a number of
the point where the ramp merges with the highway conclusions that often run counter to how clinical
(Projecting/Level 3 SA). This means that you need decision making is usually considered, such as the
to decide to speed up, slow down, or change lanes. following [29]:
You look in your mirrors and check your blind
spot seeing, that there are no other cars nearby • Experienced decision makers can draw on pat-
(Level 1 SA). You realize that this means that you terns to handle time pressure and never even
can move into the middle lane (Level 2 SA) and compare options.
that there is time to execute this move in plenty of • Expertise in decision making does not depend
time before your paths cross (Level 3 SA). You upon learning rules and procedures but on
therefore decide to move into the middle lane. The tacit knowledge.
more cars there are on the road with differing • Problems are not always solved by a clear
speeds and locations, the more variant your or the description of goals at the outset, since many
speed of the merging car is, or the worse the visi- projects involve wicked problems and ill-
bility or shorter the timescale, the more difficult defined goals.
this decision will be, and thus the more risk will be • Humans do not make sense of the world as
experienced. This is also affected by driver fatigue, “information processors” by fusing multiple
experience, distractions, alcohol, automation data streams into eventual understanding—
(which often reduces awareness), and even the instead, experience and understanding define
familiarity they have with the vehicle and the road the important data streams, and most data is
on which they are travelling. ignored.
Thus, the concept of situational awareness • Uncertainty is not necessarily reduced
helps us to understand how information is used to through more information—too much data
make accurate decisions; and how the clarity of reduces performance, while uncertainty can
the information, the environment, the training stem from an absence of contextual cues that
and expertise of the human, and their active accompany data.
involvement in the task over time helps us to • Decision making is not necessarily improved
make safe and appropriate decisions within com- by understanding assumptions since we may
plex, unpredictable, changing situations [26]. be unaware of our most flawed
The best decisions are made when key informa- assumptions.
46 K. Catchpole
Moving towards more complex, team-based “how an operating room manages cardio-pulmo-
tasks, studies of human-system relationships in nary bypass.”
socio-technical environments have also led us to
consider that cognition and decision making are
not purely the properties of what occurs in the Performance-Shaping Factors
head of one individual. In fact, cognitive pro-
cesses are often shared between different indi- In this final section, we explore how environ-
viduals working together through communication mental factors often outside the control of the
and shared culture; across material environments human can affect human performance. These
which aid in recall and action through cognitive “performance-shaping factors” include fatigue,
artifacts such as computer displays or hand- noise and vibration, lighting, temperature and
written notes; and across time, where strategies, humidity, and physical constraints of the work-
approaches, protocols, cultures, and artifacts space. A huge number of experimental studies
accumulate over time. This is known as distrib- have explored the effects of these different
uted cognition. The classic text by Hutchins stressors on a variety of tasks. They can also be
(“how a cockpit remembers its speed”) [30] con- considered in terms of staff safety, offering
siders the aircraft cockpit as the cognitive unit, environmental risks. There is a growing interest
and the people, displays, and procedures all com- in these factors and the role they play in patient
ponents of how cognition is successfully distrib- outcomes. Though there are many models, the
uted to achieve an understanding of the world general concept is that these factors adapt cog-
that would be impossible for any one component nitive capacity downwards, increasing errors.
alone. More recently, this approach has been used This creates further opportunities for failure
in anesthesia and other healthcare-related set- that further reduce human capacity, leading to a
tings [31], considering the following: spiral of increased risk. Fatigue, for example,
compromises perceptual abilities, increasing
• How information flows in tasks and between the chances of errors, and decision making,
people. reducing the likelihood of appropriate
• How tools and representations of work (such responses. Noise can mask important commu-
as protocols or checklists) are structured and nication, and can either reduce or exacerbate
how they affect the work. fatigue, depending on the types of noise and
• How the physical layout of a room or environ- individuals experiencing it. Interruptions and
ment affects the distribution of information. distractions divert attention from the primary
• How the social structure—roles, relationships, task, which can reduce hand-eye coordination,
knowledge, and goals—affects the “cogni- create task fragmentation, increasing the
tion” of the whole. chances of forgetting or omitting steps, and
• How the whole changes over time. introduces delays while the human switches
away from, and then back to, the primary task.
This alternative approach to the reductionism Temperature and humidity increase physiologi-
found in more traditional science and engineer- cal stress, can lead to dehydration and fatigue,
ing approaches has yet to be well recognized and can also create interruptions, for example,
within healthcare, but would seem extremely apt while the human wipes their brow or clears fog-
for understanding the complex, highly distrib- ging of a lens or goggles (Fig. 4.2).
uted tasks found in cardiac surgery. In particular, In surgery, there has been considerable interest
perfusion management requires the complex in exploring how task deviations occur through
coordination of people, equipment, information, these performance-shaping factors, and how they
and tasks in order to perform appropriately. No contribute to patient outcomes. The seminal study
one person has full knowledge of every aspect of by Carthey and de Leval in congenital heart surgery
this task. Thus, perhaps we should consider found that enough of these small problems that
Fig. 4.2 A human factor engineering model of threat and error in surgical care [32, 33]
were not appropriately accounted for contributed to and patient—could generate performance-reduc-
increased length of stay and the chance of death in ing problems. They could also generate human
arterial switch operations [34]. Subsequent studies errors—either technical (clinical skills or exper-
video recorded and analyzed in detail the sequences tise) or nontechnical (teamwork, decision making,
of events to allow exploration of how those minor awareness), which would also create performance-
process deviations occurred and the causes [35, reducing problems [37, 38]. In some situations,
36]. This found a model where system threats— they could be resolved with no further effects. In
from organization, environment, task, technology, others, they could combine, especially with
48 K. Catchpole
c ommunication failures, absences of staff, equip- processes and performance-shaping factors in

ment failures, or awareness failures, to create more cardiac operating rooms have allowed us to begin
serious situations. This would set up a cascade of to explore how the human factor lens can help us
events leading to a far more risky and potentially understand why we do what we do, why things
adverse situation [35]. At the same time, in the go right and why things go wrong, and what we
USA, similar studies were being conducted, show- might do—aside from trying harder—to achieve
ing similar effects [39]. Later studies [40] have more of the former, and less of the latter.
explored these work environments, expanding our
understanding of where the interoperative risks to
our patients might lie. This is summarized in the References
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The Relationship Between
Teamwork and Patient Safety 5
Sallie J. Weaver, Lauren E. Benishek, Ira Leeds,
and Elizabeth C. Wick
“The way a team plays as a whole determines its success. You may have the greatest
bunch of individual stars in the world, but if they don’t play together, the club won’t be
worth a dime.”
—Babe Ruth
systems-oriented lens highlights that there are

Introduction likely a number of factors contributing to these
complications, studies demonstrate that the qual-
The publication of the National Academy of ity of teamwork processes—an overarching term
Medicine’s (formerly the Institute of Medicine) for teaming concepts that includes communica-
report To Err is Human in 2000 marked one of the tion, coordination, collaboration, situational mon-
most prominent public acknowledgments of the itoring, backup behavior, planning, debriefing,
error-prone nature of modern medicine. Medical and other behaviors—accounts for significant
errors were estimated to be the attributable cause variation in technical surgical errors [4–7]. For
of death in 50,000–100,000 hospitalized patients example, a study of 300 surgical cases combining
per year [1]. Although surgery-specific error rates observations of teamwork collected by trained
have been difficult to obtain, the magnitude of 50 observers with retrospective chart review found
million surgical procedures in the USA per year that the odds of complication was nearly five
has spurred increasing interest in what leads to times higher (ORadjusted = 4.85, 95 % CI: 1.30–
surgical complications [2]. Importantly, serious 17.87) when fewer teamwork behaviors (e.g.,
complications are thought to occur in two to five information sharing, situation monitoring) were
million cases with up to half of these leading to observed, after controlling for patient characteris-
death within 30 days of surgery [1, 3]. Although a tics [8].
Breakdowns in teamwork and communication
are common risk factors for unintended events,
S.J. Weaver, PhD, MHS (*) • L.E. Benishek, PhD including retained surgical instruments and sponges
Department of Anesthesiology and Critical Care [9]; wrong-side/wrong-site, wrong-procedure, and
Medicine, Armstrong Institute for Patient Safety wrong-patient events [10]; and inadvertent disease
& Quality, Johns Hopkins University School of
Medicine, 750 East Pratt Street, 15th Floor, transmission to transplant recipients [11]. Analyses
Baltimore, MD 21202, USA of 258 closed malpractice claims from multiple
e-mail: [email protected]; [email protected] liability insurers involving surgical errors resulting
I. Leeds, MD, MBA • E.C. Wick, MD in patient injury implicate communication break-
Department of Surgery, Johns Hopkins University downs in 24 % of cases [12]. Studies of claims
School of Medicine, and The Johns Hopkins involving trainees across disciplines implicate
Hospital, 600 N. Wolfe Street Tower 110,
Baltimore, MD 21287, USA teamwork breakdowns in up to 70 % of closed
e-mail: [email protected]; [email protected] cases [13]. Additionally, the Joint Commission, a

52 S.J. Weaver et al.
national accreditation organization tracking senti- efining Teams, Teamwork,

D
nel events, also routinely finds communication in and Multi-Team Systems
the top three persistent root causes of patient safety
issues in US hospitals [14]. Furthermore, team- A team is defined as an identifiable group of two
work and communication processes have also been or more people working interdependently toward
associated with case efficiency [15], OR utilization shared, mutual goals that could not be accom-
and scheduling [16, 17], and burnout [18, 19]. plished effectively, if at all, by a single person.
Also known in the surgical literature as “non- [28, 29]. Teamwork refers to the behaviors (e.g.,
technical skills,” teamwork in the operating room communicating and sharing information, c hecking
and across the perioperative care continuum has for mutual understanding), attitudes (e.g., belief in
been a topic of study for over two decades [20, 21]. the collective ability of the team and need for
This work highlights examples of effective and teamwork), and cognitions (e.g., shared mental
ineffective teamwork in practice (see Table 5.1), models) teams use to communicate, coordinate,
critical teaming skills, and interventions designed and collaborate their efforts to achieve shared,
to strengthen effective teamwork in practice. collective goals. Studies of teamwork in surgery
The evidence across disciplines and settings and other domains of care reflect the heterogene-
identifies multiple hallmarks of effective teams. ity of teams and teaming in practice. Teams can be
These “expert teams” and effective team mem- defined in terms of patient population (e.g., pedi-
bers are committed to (1) actively and transpar- atric surgical teams) [30], disease or procedure
ently sharing unique information; (2) developing types (e.g., colorectal surgery teams, surgical
and maintaining shared similar mental models of oncology teams), professional identity (e.g., sur-
the team’s goals, tasks, and interdependencies; gical ICU nursing teams), setting (e.g., ambula-
(3) backing each other up as appropriate; (4) tory/day surgery team), and crisis scenarios (e.g.,
using strategies that facilitate collective sense- rapid response teams) [31].
making and closing the loop to ensure shared Teams can also vary in the degree to which the
understanding of information and tasks; (5) roles contributing to team goals and the individu-
believing in the importance of the team’s goal, als filling each role remain stable over time. A
believing that teamwork is critical to achieving simple 2 × 2 typology of healthcare team composi-
this shared goal, and taking other’s behavior into tion developed by Pamela Andreatta [32] is help-
account; (6) mutually monitoring the situation ful for understanding and comparing teams with
and team progress in order to adapt or adjust their (1) stable roles and stable personnel; (2) stable
collective strategy or individual contributions as roles, but variable personnel; (3) variable roles,
needed; (7) discussing interdependencies in order yet stable personnel; and (4) variable roles com-
to coordinate their actions and tempos; and (8) bined with variable personnel. For example, surgi-
mutually trusting that their fellow team members cal teams may be static or dynamic (i.e., ad hoc),
will perform their roles and protect the interests with more handoffs occurring among dynamic
of the team [24, 25]. Additionally, the evidence teams that, in turn, demand more explicit commu-
underscores that generalizable teaming skills and nication and coordination to be optimally effec-
attitudes can be developed through well-executed, tive [33]. Different people may switch into and
systems-oriented team training interventions [26, out of the same role during a defined period of
27]. In this chapter we summarize the science time (e.g., a new relief circulator may join a case
examining team effectiveness, offering practical while others go to lunch or break) and different
strategies for optimizing teaming across the peri- roles may join or leave as needed (e.g., a specialist
operative continuum, and also highlighting where may participate in a portion of a case). Across the
empirical evidence remains sparse. perioperative care continuum teams can also
Table 5.1 Three examples of teamwork and communication in practice
Example type Example
Clinical care: Ineffective Scrub technician: Dr. Smith, would you mind confirming what would you like this specimen labeled?
(from Hu et al. [22]) Surgeon: We already talked about it
Clinical care: Effective Surgeon: You guys are going to put in a central line? Or what do you want to do?
(from Hu et al. [22]) Anesthesia attending: Well, we … I need to talk to you about it. Her INR is 1.4. I’m not a big fan of sticking her neck
Surgeon: Sounds fair to me
Anesthesia attending: So if we do … I’m wondering if we can put in a groin, like if you guys put in a groin line in
Surgeon: So I’ll tell you what … Why don’t we see what you get here? This is going to be one of those situations where we could make an
incision and know whether this is going to be hard or not. We wouldn’t want to do anything like a big groin line
Anesthesia attending: Right, and I think that’s right
Surgeon: But we’ll prep everything out and … then if we get in and we decide, “Yeah, this is going to be scarier than we wanted,” we’ll
put in a groin line
Anesthesia attending: That sounds great
Surgeon: Sound good?
Anesthesia attending: I think that’s the perfect plan
Surgeon: Okay, perfect
Improvement: Effective Multiple members of a surgical team have expressed concern at what they feel is an unusually high number of surgical site infections
5 The Relationship Between Teamwork and Patient Safety
being reported for last quarters’ colorectal cases

The institution has in place a comprehensive unit-based safety program (CUSP) team for its colorectal surgery service line [23]
This multidisciplinary surgical improvement team has decided to address the increased surgical site infection rate for this quarter’s project
A round of brainstorming with surgeons, anesthesiologists, nurses, and scrub technicians is used to generate ideas about what may be
contributing to the increased infection rate
Multiple team members mention concerns about “dirty” and “clean” instrument handling
Once surgical instruments are contaminated by stool during the latter half of colon resection, “dirty” items are supposed to be set aside to
reduce wound contamination during skin closure where the risk of surgical site infection is highest
Team members note that perhaps the segregation of contaminated instruments is not occurring 100 % of the time
They then find themselves overwhelmed by the number of possible reasons why instruments are being mishandled, which include lack of
training, a rushed atmosphere, and inadequate spare instruments
Rather than trying to address all of these reasons individually, the team comes up with a simplified solution that should cover all causes
A small, second sterile surgical “closure tray” will be added to these cases to ensure optimal sterility for final skin closure
The team then enlists the help of their administrative champion to demonstrate the potential cost savings of reduced surgical site
infections while advocating for the additional surgical equipment needed for each case
One month later, the closure tray has been added to each colorectal procedure
53
By the next quarter, surgical site infection rates following colorectal cases are below their pre-intervention baseline
address different types of tasks. For example, tors. For example, care transitions across a preop-
team-based work can focus on (1) advice and erative clinic team, a preoperative evaluation or
involvement (e.g., unit, service line, or depart- testing center, a prep area or regional anesthesia
mental patient safety or quality improvement team, an intraoperative team, a PACU team, and a
teams), (2) production and service (e.g., central postoperative floor care team. Intraoperative sur-
sterile processing teams), (3) projects and develop- gical teams depend on teams working in central
ment (e.g., research teams focused on innovation), sterile processing and supply chain teams for the
and (4) action and negotiation (e.g., direct care tools and materials they need to complete their
team involved in a particular case, rapid response work. These teams, in turn, depend on the intraop-
teams) [34]. Surgical teams in the operating room erative team to send back tools and alert them
are most often discussed as action teams, defined when changes in kits or supplies are needed.
as “highly skilled specialist teams cooperating in Collectively, all of these teams are working
brief performance events that require improvisa- toward the shared, mutual goal of providing high-
tion in unpredictable circumstances” ([34], est quality, safe care for each individual patient.
p. 121). However, it is critical to remember that However, the interdependencies among the mul-
direct care is not the only type of team-based work tiple players that must align their efforts to carry
important for safe, high-quality, high-value surgi- out a single case are often underappreciated and
cal care. Clinicians, nonclinical perioperative not clearly understood in practice.
staff, and administrators also participate in project Such complex networks of teams, known as
teams and advice/involvement teams dedicated to multi-team systems (MTSs), are defined by two
improving care safety, quality, and value. or more component teams that work interdepen-
While many generalizable teaming processes dently and interface directly in order to achieve at
are important across different team types and dif- least one overarching shared goal that any one of
ferent types of team-based work, these typologies the individual teams could not achieve on its own
are helpful for considering situations or team [37, 38]. Each component team works toward its
configurations in which some team behaviors, own proximal goals in addition to the overarch-
attitudes, or cognitions may need more (or less) ing, more distal MTS goal(s), and sometimes
attention in practice. For example, teams that team goals may compete with the overarching
vary in roles or personnel must consider allocat- MTS goal [39]. For example, team scientists par-
ing slightly more time and attention to developing simoniously describe the work of an MTS
and reestablishing shared mental models about responding to a car accident, including a fire crew,
the strategies that will be used to coordinate their emergency medical team, surgical team, and
actions compared to relatively more static teams. postsurgical care team as core component teams
Conversely, while highly stable teams working working interdependently to achieve their mutual
together over time can develop the shared cogni- distal goal, survival of the patient, while also
tive structures and behavioral norms that enable working toward their own proximal goals (e.g.,
them to adapt efficiently when needed, they can stabilizing and transporting the injured person)
also become overly reliant on implicit coordina- [37]. The MTS concept is helpful in considering
tion strategies, missing opportunities to explicitly teamwork in surgery given the number of teams
verify information or shared understanding which and players that must align their efforts and infor-
can lead to glitches and unintended errors [35]. mation in order to achieve safe, effective, efficient
While a co-located multidisciplinary team may care for each patient undergoing surgery. Studies
complete a particular surgical procedure, a micro- of MTSs also highlight key teaming processes
systems-oriented lens emphasizes thinking of the that are even more critical in such contexts. For
perioperative continuum of care as the work of a example, boundary spanning—actively reaching
team of teams [36]. Effective, efficient, and safe out and interacting across team boundaries—is a
surgery often requires the collective efforts of five critical skill for teams working as part of an
to six different teams plus individual collabora- MTS. Explicit forms of coordination and
5 The Relationship Between Teamwork and Patient Safety 55
c ommunication also become more important in Building on these conceptual advancements,

MTS settings given that only a few members of Ilgen and colleagues [44] introduced the input-
each component team may ever directly interact mediator-output-input (IMOI) model of team per-
with one another. formance, which differed from IPO models in two
major ways. First, process is replaced with media-
tor, which subsumes both emergent states and
Models of Teams and Teamwork processes as defined by Marks et al. [43]. Second,
the IMOI model acknowledges that team perfor-
Numerous models in the social and organizational mance can be episodic and recursive [43] such
sciences describe teams, their development, pro- that outcomes from past performance periods can
cesses, and factors that influence their effective- influence subsequent performance. Take as an
ness. It is outside the scope of this chapter to offer example an uncommon but critical surgical emer-
a thorough history of team performance models; gency like cardiac arrest during an otherwise
however, understanding the theoretical founda- uneventful low-risk cholecystectomy. The well-
tions of healthcare team processes and perfor- trained operating room team performed all of the
mance is critical for developing the skills and routine portions of the surgical encounter cor-
interventions that support expert teams (for com- rectly (e.g., “time out” to review surgical plan,
prehensive reviews see Mathieu [40] and Cannon- close oversight of the sterile field, good communi-
Bowers [41]). cation between surgeon and anesthesiologist), but
Early thinking about teamwork was largely early into the case it was noted that the patient was
linear, evidenced by conceptual models adopting hypotensive and lost his pulse. Every member of
what is known as an input-process-output (IPO) the team scrambled into action to perform CPR
approach to depicting teamwork performance and reestablish circulation. Although the patient
effectiveness. Inputs were defined as antecedents survived, team members later shared that the dis-
or contextual factors (e.g., characteristics of indi- ruptive event illuminated multiple issues that had
vidual members, the practice environment, or gone previously unnoticed (e.g., the “crash cart”
organization) that impact the affective, behav- was not stored in its appropriate place in a hall-
ioral, and cognitive teaming processes believed to way alcove; roles were not clearly assigned in the
be the mechanisms through which teams achieve transition from routine operating roles to arrest
collective outcomes. team; postarrest infusions were not readily avail-
Although a useful starting point for understandable). In preparation for the next intraoperative
ing and describing teamwork, the traditional IPO arrest, the members of the team initiated a quality
model does not adequately capture the dynamism project with the OR team nurse educator to
and adaptive nature of teamwork over time [42]. develop a daily checklist to ensure that equip-
Furthermore, conceptualizations of teamwork pro- ment, roles, and medications were available at all
cesses were vague, leading Marks, Mathieu, and times. As a result of these efforts, the surgical
Zaccaro [43] to formally define them as “mem- team felt that it was more effectively ready to
bers’ interdependent acts that convert inputs to handle the next intraoperative emergency.
outcomes through cognitive, verbal, and behav-
ioral activities directed toward organizing task-
work to achieve collective goals” (p. 357). Yet, this Healthcare Specific Models
definition still failed to account for the affective
(e.g., trust) and cognitive (e.g., shared awareness) Despite burgeoning interest, well-developed, yet
drivers of teamwork. Marks et al. [43] termed practically relevant models of healthcare team-
these mechanisms emergent states and defined work delineating critical antecedents, processes,
them as “properties of the team that are typically and outcomes across the care continuum are still
dynamic in nature and vary as a function of team rare [45]. One example is the integrative (health-
context, inputs, processes, and outcomes” (p. 357). care) team effectiveness model (ITEM) [31].
This model depicts contextual factors (e.g., team organizational characteristics (e.g., physical lay-
training) as critical inputs that influence elements out, management structure, technology), patient
of team task characteristics, including task type characteristics (e.g., comorbidities, knowledge,
(e.g., project vs. patient care), team features attitudes, and behaviors), task characteristics
(e.g., level of interdependence), and team com- (e.g., interdependencies, procedural steps), and
position (e.g., discipline, tenure), which in turn individual team member characteristics (e.g.,
drive team processes and emergent states. It education, previous experience, personality),
notably includes forces external to the organiza- influence within- and between-team performance
tion, such as social, regulatory, and policy fac- and effectiveness. Although depicted as individ-
tors, that affect mediators of team performance. ual boxes for the sake of parsimony, these charac-
Furthermore, team outcomes are distilled into a teristics should be considered in singularity but
3 × 2 framework that encompasses the level of rather as a constellation of factors that shape the
analysis (e.g., patient, team, and organizational) context in which teamwork occurs. The pattern
and the nature of the measure (e.g., objective vs. of these factors has a much stronger influence
subjective). Reflecting the same limitation of than any one factor by itself.
other IPO models, ITEM is linear in nature and Moderators, such as team training and culture
therefore does not fully represent the progressive (i.e., shared, multidimensional values, believes,
nature of teamwork. This problem would be eas- and perceptions of the work environment), are
ily solved with the inclusion of a feedback loop. also shown to influence the relationship between
Moreover, it seems unlikely that some external inputs and team processes. Moderators are inputs
factors demonstrate a direct relationship to task that can change the nature of a relationship
design characteristics. between two other factors. For example, training
Other healthcare teamwork models are limited team members in generalizable teamwork com-
to specific contexts as a result of the difficulties petencies can help ad hoc teams overcome the
with creating practical models that span the gener- disadvantages associated with a lack of previous
alities of very different healthcare teams. For experience working together [47].
example, after a systematic review of 35 peer- One aspect of Weaver et al.’s model is that
reviewed articles investigating teamwork in the inputs are shown to affect both intra- and inter-
ICU, Reader and colleagues [46] presented a team processes and emergent states, which sub-
framework of ICU team performance. The frame- sequently impact intra- and inter-team outcomes.
work centers on team processes such as communi- The model is one of the first to address care as
cation, leadership, and coordination, and connects the work of an MTS. Weaver et al.’s model dem-
them to patient- and team-focused outcomes. onstrates the complexity of these systems and
Consistent with IMOI models, the authors note showcases inter-team processes (e.g., boundary
that psychosocial factors (i.e., emergent states) spanning, entrainment, collaborative sensemak-
influence team outcomes and include a feedback ing) needed in order for multiple teams to col-
loop linking outcomes to inputs. laborate together successfully.
In an effort to integrate aspects of both within-
and between-team interactions while acknowl-
edging the dynamic, episodic nature of team ractical Principles for Effective
P
performance, Weaver et al. [45] advanced a model Teaming in Surgery
of healthcare teamwork for patient safety (Fig. 5.1).
This model shows how macro (e.g., national, In the surgical suite, patient care requires vigilant
organizational), meso (e.g., department, and unit), synchronization of efforts in a team with fluid
and micro (e.g., individual patients or providers) membership, including highly specialized clini-
level factors, such as environmental characteris- cians with diverse knowledge, skills, and atti-
tics (e.g., social policy and regulatory programs), tudes (KSAs) [48]. Most surgical procedures
Fig. 5.1 An integrated model of team effectiveness for patient safety in healthcare, Weaver et al. [45]. Reprinted with
permission from Oxford University Press, USA
require at least four multidisciplinary team mem- The result was the “Cs of Effective Teamwork,” a
bers: an anesthesia provider, a surgeon, a circu- simple framework describing a set of critical con-
lating nurse, and a scrub nurse or technician [49]. siderations for teamwork. The Cs include processes
Each is responsible for a specific role necessitat- and emergent states (e.g., cooperation, conflict,
ing unique educational background and experi- coordination, communication, coaching, cognition)
ence. Despite these differences, they must be able as well as influencing conditions (e.g., composition,
to effectively perform interdependently to ensure culture, and context) that impact the aforemen-
safe and successful surgery. tioned processes. See Salas et al. [55] for complete
Research on teamwork has amassed a vast body discussion of the framework’s development.
of literature describing a wide array of shared KSAs The Cs heuristic is a useful tool for organizing
necessary for teams to accomplish their task(s) what healthcare leaders and team members need
[50]. Many reviews exist to address the different to know to practice effective teamwork. Adap
factors that can impact teamwork [34, 40, 41, 51, tations of the Cs heuristic has already been
52]. However, few offer practical guidance needed applied to the medical context in order to explain
by surgeons and other medical professionals to team effectiveness for patient safety [45] and as a
enact and optimize effective teamwork [53]. Salas framework for guiding the planning and develop-
and colleagues [45, 54, 55] sought to create a parsi- ment of interprofessional medical education [54].
monious summary of our current knowledge about Table 5.2 defines each component of the frame-
teamwork and package it in a way that would be work and provides an example of how it can
more practically useful than previous frameworks. manifest within a surgical team.
embership and Team Life Span

M with the purpose of completing a single surgical
Considerations procedure before disbanding. Unstable team
membership across cases ensures that team com-
As acknowledged in both the ITEM model [31] position and relative status of individual members
and Weaver et al.’s healthcare teamwork model change [56] from procedure to procedure, creating
[45], team composition can affect the mechanisms additional teamwork challenges for surgical
that determine team effectiveness. Yet, the impli- teams. It may be difficult to establish rules and
cations of ad hoc team membership for patient norms unless some core members remain constant
safety need further consideration. Surgical teams, (cf. Arrow & McGrath [57]), though a core group
particularly in emergency or after-hours proce- of members accustomed to working together can
dures, often are ad hoc; that is, they come together create dysfunctional status hierarchies [56]. Such
Table 5.2 Cs of team performance (adapted from Weaver et al., [45] and Salas et al. [55])
Component Definition Clinical context Example
Cooperation The motivational drivers of Surgeons, nurses, and OR An effort to improve patient
teamwork. In essence, the staff bring unique skill flow in the OR focuses on
attitudes, beliefs, and sets and perspectives to better integrating the
feelings of the team that the care of patients anesthesia, surgical, and
drive behavioral action nursing needs of the patients
from contributions of each
team member
Conflict management Proactively managing Different team members’ While preparing a difficult
perceived incompatibilities unique viewpoints and surgical field involving a
in the interest, beliefs, or training make conflicting patient’s complete upper
views held by one or more beliefs likely in the OR extremity, a surgeon and
team members circulator nurse reconcile
different approaches to sterile
preparation of patients
Coordination The enactment of OR teams maintain An OR completing a case
behavioral and cognitive well-established pages overhead, “OR6 out,
mechanisms necessary to workflows so that moderate turnover” and all
perform a task and standardized processes processes required to clean the
transform team resources proceed with limited room with the appropriate
into outcomes oversight thoroughness, prepare for the
next patient, and obtain any
special equipment occur
automatically within a
prespecified time period
Communication A reciprocal process of OR teams iteratively During a “time out”
team members’ sending share and receive both old procedure, a patient’s
and receiving information information and any new identification, existing
that forms and re-forms a changes while patients are medical problems, surgical
team’s attitudes, behaviors, proceeding through a plan, special precautions, and
and cognitions surgical workflow to team introductions are
ensure that all team formally reiterated to confirm
members remain well full team agreement
informed
Coaching The enactment of Effective OR teams The OR charge nurse
leadership behaviors to include responsive performs further information-
establish goals and set third-party support that gathering with other OR teams
direct that leads to the can intervene when when a circulator nurse
successful accomplishment necessary reports that case carts are
of these goals being sent to rooms without
complete instrument trays
(continued)
Table 5.2 (continued)
Component Definition Clinical context Example
Cognition A shared understanding OR teams have narrowly Anesthesia care of the surgical
among team members that defined roles with patient proceeds with virtually
is developed as a result of minimal overlap to ensure no intervention from the
interactions including focus on critical surgeon because the
knowledge of roles and safety-related activities guidelines for safe anesthesia
responsibilities; team care and triggers for further
mission objectives and intervention have already been
norms; and familiarity with agreed upon at the
teammate knowledge, institutional level
skills, and abilities
Composition Individual factors relevant Roles in the OR are Scrub assistants are assigned
to team performance; what specific and each to cases appropriately based
constitutes a good team representative member of on their experiences with the
member; what is the best the team is specifically instruments and equipment
configuration of member assigned to effectively necessary for a particular case
knowledge, skills, and provide their role in
attitudes; and what role patient care
diversity plays in team
effectiveness
Context Situational characteristics OR design should Cardiothoracic ORs are larger
or events that influence the incorporate purpose-built than average rooms to
occurrence and meaning of spaces for resource- accommodate the additional
behavior, as well as the intensive cases equipment for
manner and degree to cardiopulmonary bypass
which various factors
impact team outcomes
Culture Assumptions about Effective OR teams Administrators encourage
relationships and the should facilitate frontline quality improvement
environment that are continuous quality ideas and champion these
shared among an improvement and proposals through appropriate
identifiable group of prioritize patient safety channels
people and manifest in
individuals’ values, beliefs,
norms for social behavior,
and artifacts
hierarchies can have implications for the integra- While unclear what the implications are for patient
tion of new or rotating team members. safety and other performance effectiveness out-
Though quantitative research into the effects of comes, it certainly seems likely that changing
surgical team membership is somewhat sparse, membership limits team efficiency.
extant literature suggests that surgical team size To reduce the negative impact of these chal-
and continuity of membership may influence per- lenges, all staff participating in operative proce-
formance [58–60]. For example, Xu and col- dures should be competent in transportable or
leagues [61] found evidence that team members’ task-contingent teamwork KSAs. Cannon-Bowers,
familiarity contributed to reductions in operative Tannenbaum, Salas, and Volpe [62] developed a
time, even when controlling for individual sur- 2 × 2 framework of teamwork competencies that
geon experience. Though further research is defines the intersection of competencies related to
needed to understand the precise mechanisms the team (team specific vs. team generic) and those
through which membership dynamics operate, related to the task (task specific vs. task generic).
these findings suggest that changing membership Transportable competencies have the widest range
can be disruptive to some surgical team processes. of applicability as they are both task and team
generic, meaning that they can be generalized to Return on investment analysis has also dem-
any task or team context. TeamSTEPPS 2.0® (http:// onstrated the impact of systematic interventions
www.ahrq.gov/professionals/education/curricu- on teamwork in practice. For example, one large
lum-tools/teamstepps/instructor/index.html) is an academic system implemented a comprehensive
example of a training program that has been created crew resource management intervention, one
to teach transportable teamwork competencies to form of team training, across six perioperative
clinicians. Task-contingent competencies, on the service lines. The system demonstrated 15.6 %
other hand, are only applicable to certain team tasksfewer hospital-acquired surgical site infections
(e.g., knowledge of the steps involved in a particu- than expected over a 3-year evaluation period
lar surgical procedure) but like transportable com- resulting in cost-saving estimates of $895,906 to
petencies, they are team generic. A minimal level over $2.3 million dollars [71].
of proficiency with transportable or procedure- There are multiple types of team training and
contingent (i.e., task-contingent) teamwork compe- examples of their implementation in periopera-
tencies would allow staff to be effective team tive and other clinical settings. These are sum-
members regardless of their rotating memberships. marized in Table 5.3.
However, this existing evidence underscores
that developing and maintaining effective teaming
Interventions to Develop skills and habits go beyond classroom-based team
and Support Effective Teaming training interventions. Effective teaming in prac-
in Surgery tice is maintained by team-oriented mindsets, sys-
tem structures that facilitate communication,
Over three decades of evidence underscores that coordination, and collaboration, and good team-
expert healthcare teams and expert care providers work habits [26]. For example, effective teaming
who are effective at teaming invest time in devel- in practice requires relinquishing an attitude of
oping and practicing teamwork skills [25, 63, 64]. individuality focused on individual expertise, con-
Existing evidence demonstrates that systems- tributions, or leadership that has tended to charac-
oriented team-training interventions that are terize surgical practice to an attitude that recognizes
mindfully implemented with mechanisms to sup- interdependencies and value collaboration. In an
port sustainment can be effective in reducing sur- observational study of complex surgical cases,
gical morbidity and mortality, improving quality teams working with surgeons adopting a transfor-
and safety indices, and can contribute to improve- mational (i.e., team-oriented) leadership style
ments in surgical patient satisfaction [65–68]. For demonstrated 3 times more information-sharing
example, Neily et al. conducted one of the more behavior (p < 0.0001) and were 5.4 times more
robust studies demonstrating both the association likely to speak up (p = 0.00005) [22]. Additionally,
between teamwork and improved healthcare qual- they were 12.5 times less likely to demonstrate
ity, as well as a beneficial teamwork-based inter- poor teamwork behaviors (p < 0.0001). For periop-
vention bundle within the Veterans Affairs hospital erative leaders in particular, it is important to
network [65, 66, 69, 70]. Over 100 sites, totaling emphasize and reinforce that surgical care is the
182,409 procedures, were included. The interven- work of multiple individuals and teams who are
tion group implemented a bundled intervention mutually dependent on one another. This includes
that included team training, operative briefings, recognizing and reinforcing care providers and
and pre-procedure checklists that included a hard support staff across the perioperative continuum
stop that prevented the operation from proceeding that invest in proactively communicating, coordi-
unless all team members actively participated in nating, and collaborating within and across team
the interventions. These hospitals experienced an or disciplinary boundaries.
18 % reduction in surgical mortality versus a 7 % Additionally, system structures (e.g., checklists,
reduction in propensity-matched patients at con- integrated EHRs, interdisciplinary meetings, and
trol hospitals (p = 0.01). rounds) and teaming habits (e.g., briefing,
Table 5.3 Team training strategies (adapted from Salas, Weaver, Rosen, and Gregory [72])
Primary teamwork
Team training strategy Definition competencies targeted Best practices
Assertiveness training Focuses on • Backup behavior • Define training objectives
communication strategies around task-relevant
that support task-relevant assertiveness and differentiate
and team performance- from aggressive behaviors
relevant assertiveness • Closed-loop • Compare/contrast effective
communication and ineffective assertiveness
• Conflict management • Include realistic time pressures
• Mutual trust or other stressors to allow
• Psychological safety practice using and reacting to
appropriate assertiveness
• Leadership
Cross-training Team members learn the • Accurate and shared • Degree of interdependency
roles that comprise the mental models of and specialization should
team and the tasks, duties, team roles and drive the type of cross-training
and responsibilities responsibilities you choose
fulfilled by fellow team • Clarify interdependencies,
members define roles and responsibilities
of other team members
• Provide opportunities to
shadow another role if possible
• Facilitates reasonable
expectations of one another
Error management Active learning strategy • Collective efficacy • Ensure trainees understand
training in which participants are purpose: to encounter errors
encouraged to make and to have opportunities to
errors during training practice managing them in a
scenarios, analyze these safe environment
errors, and practice error • Cue-strategy • Frame errors as positive
recognition and associations opportunities for learning
management skills • Shared mental • Embed the opportunity to make
models errors into training scenarios by
providing minimal guidance
during scenario
• Team adaptation • Follow the scenario with
immediate feedback and
discussion to facilitate learning
Guided team Team training strategy • Backup behavior • Define the targeted teaming
self-correction designed around a cycle skills at the beginning
of facilitated briefings and • Collective orientation • Record positive and negative
debriefings that occur examples of each teaming skill
around a training scenario during team performance
or live event episode
• Closed-loop • Classify and prioritize
communication observations, diagnose
strengths and weaknesses, and
identify goals for improvement
before beginning debrief
• Cue-strategy • Set the stage for team
associations participation and solicit
• Mission analysis examples of teamwork
• Mutual trust behavior during debrief
• Shared mental models
• Team adaptation
• Leadership
(continued)
Primary teamwork
Team training strategy Definition competencies targeted Best practices
Metacognition Teaches strategies for • Cue-strategy • Develop training objectives
training analyzing, updating, and associations around cognitive processes
aligning team mental such as planning, monitoring,
models of the team’s task, and reanalysis
coordination strategy, and • Mission analysis • Structure metacognitive
contingency plans • Shared mental practice tasks around a task or
models subject that trainees have
• Team adaptation preexisting knowledge about
Team adaptation and Develops transportable • Backup behavior • Develop training objectives
coordination training teamwork competencies that target generalizable,
(TACT) and tools (e.g., checklists) transportable teaming skills,
that can support effective team-specific competencies can
team processes. Crew also be incorporated for intact
resource management teams
training is a form of • Closed-loop • Train intact teams together if
TACT communication possible
• Cue-strategy • Create opportunities for
associations guided and unguided practice
• Mission analysis • Develop feedback mechanisms
that engage self-reflection and
team self-correction following
practice opportunities
• Mutual performance • Develop tools that support
monitoring effective teamwork, but
• Leadership recognize that tools alone
• Shared mental (e.g., checklists) cannot
models optimize team performance
debriefing, semi-structured handover processes) implementation. They are mechanisms for strength-
that are mechanisms for facilitating communica- ening effective teamwork habits (e.g., situation
tion and coordination are critical elements of effec- monitoring, and transparent and proactive commu-
tive teamwork in practice [26, 64, 73]. For nication, such as speaking up with concerns or ask-
example, mechanisms for proactively addressing ing for clarity) and are difficult to implement
potential communication breakdowns or differ- effectively. Existing studies demonstrate that brief-
ences in mental models such as preoperative briefings are most effective when implemented in a
ings and postoperative debriefings have been team-oriented environment with a positive safety
associated with improvements in compliance with culture, and benefit from engaged, safety-oriented
evidence-based practices, early detection of poten- leadership [82–84].
tial safety hazards, improved communication
among perioperative personnel, and decreased
complications [74–77]. Their effectiveness, how- Conclusions
ever, is moderated by their implementation [78],
with multiple observational studies often demon- Current evidence suggests that surgical environ-
strating wide variation in participation, topics dis- ments are at high risk for serious medical errors
cussed, and quality [79–81]. Though briefings and and frustration when teaming and communication
debriefings are helpful, they are not a panacea for are poor or break down. Effective teamwork does
eliminating the risk of error and require mindful not happen naturally or magically however. Just
as expert players in team sports must invest time for measuring teamwork behaviour in the operating
theatre. Qual Saf Health Care. 2009;18(2):104–8.
to develop their teaming skills, so too must expert
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Breizat A-HS, Dellinger EP, et al. Changes in safety
29(6):491–8. attitude and relationship to decreased postoperative
81. Weaver SJ, Rosen MA, DiazGranados D, Lazzara morbidity and mortality following implementation of
EH, Lyons R, Salas E, et al. Does teamwork a checklist-based surgical safety intervention. BMJ
improve performance in the operating room? A Qual Saf. 2011;20(1):102–7.
Enterprise Risk Management
in Healthcare 6
James M. Levett, James M. Fasone,
Anngail Levick Smith, Stanley S. Labovitz,
Jennifer Labovitz, Susan Mellott,
“Risk management is a culture, not a cult. It only works if everyone lives it, not if it’s
practiced by a few high priests.”
—Tom Wilson
The American Society for Healthcare Risk

verview of Enterprise Risk
O Management defines ERM in this way: “Enterprise
Management risk management in healthcare promotes a com-
prehensive framework for making risk manage-
All organizations face risk and virtually all activi- ment decisions which maximize value protection
ties of an organization involve risk. Risk can be and creation by managing risk and uncertainty and
defined as an event or a circumstance that can have their connections to total value” [1]. ERM is inte-
a negative impact on the organization, and it cre- grated risk management that recognizes the fact
ates uncertainty in both planning and operations. that risks are not isolated but are interconnected
As a result, organizations manage risk by first and at times cascade to create patient harm.
identifying and analyzing it, and then determining Furthermore, it provides a framework to recognize
whether and how it should be modified. Enterprise and manage all potential threats to the
risk management (ERM) may be thought of as a organization.
process embedded into an organization and is From the standpoint of an operating room envi-
devoted to finding and managing all types of risks. ronment, ERM is looking outward to identify risks
in other areas of the organization, that while not
restricted to the operating room may impact peri-
J.M. Levett, MD, FACS (*) operative patient care. This chapter provides an
Department of Surgery, UnityPoint St. Luke’s overview of risk management principles and
Hospital, 1026 A Ave. NE, Cedar Rapids,
IA 52402, USA
J. Labovitz, BS, Manag Econ
J.M. Fasone, ARM, RPLU 536 Tremont St, Boston, MA 02116, USA
CRG Medical, 9700 Bissonnet Street Suite 2800, e-mail: [email protected]
Houston, TX 77036, USA
S. Mellott, PhD, RN
Department of Nursing, Texas Woman’s University,
A.L. Smith, BA, Soc, MA, Soc 6700 Fannin Street, Houston, TX 77030, USA
Operations, CRG Medical, 9700 Bissonnet Street e-mail: [email protected]
#2800, Houston, TX, USA
D.B. Dotan, MA, CQIA
Patient Safety Evaluation IT, CRG Medical, Inc.,
S.S. Labovitz, BSBA, JD 9700 Bissonnet Street, Suite 2800, Houston, TX
2640 Lake Shore Drive, Riviera Beach, FL 33404, USA 77036, USA
e-mail: [email protected] e-mail: [email protected]

68 J.M. Levett et al.
how risk should be in surgical services. Although isk Management in Healthcare

R
there is certainly some overlap with this chapter, Organizations
surgical and operating room risks are covered in
greater detail in Chapter 33. Risk and patient safety are closely connected in
healthcare organizations, and the disciplines of
safety and risk management are therefore inter-
Principles of Risk Management related. While accreditation organizations such
as The Joint Commission and DNV Healthcare
Principles of risk management have been have definite requirements related to patient
described by various organizations and are well safety and risk, most organizations go beyond
summarized in the ISO 31000:2009 risk manage- these basic requirements and have adopted a
ment standard [2]. The key principles are sum- business or quality management system incorpo-
marized in Table 6.1. rating risk analysis and patient safety as key ele-
The ISO 31000 standard describes a risk man- ments [3]. This approach relies on the Donabedian
agement framework that becomes part of the model of healthcare delivery in which structure is
management system of the organization. The created by the organization to ensure timely, effi-
process of creating this framework is described cient, and safe healthcare process delivery with
in Table 6.2. favorable outcomes for the patients served [4].
The first step in assessing ERM is to identify
where risk resides within the organization.
Table 6.1 Principles of risk management

Identifying Risk
• Create and protect value
• Be part of all processes Risk can be categorized for any organization at the
• Be part of decision making
enterprise level, and commonly used risk domains
• Be used to handle uncertainty
in healthcare are listed in Table 6.3. The domains
• Be systematic and timely
are described with simple definitions and specific
• Be based on the best data
examples. The last column is devoted to key risk
• Be tailored to the environment
• Consider human factors
indicators (KRIs). A KRI is a metric for measuring
• Be transparent and inclusive how risky an organizational process or service line
• Be responsive and iterative is and can be thought of as an early warning indica-
• Support continual improvement tor of a potential event that may harm the process/
organization/patient. Ideally the KRI is a leading
indicator with a predictive value related to the par-
ticular risk identified. The ERM goal is to identify
risks throughout the organization using risk domains
Table 6.2 Creating a risk management framework as a guide, and then to summarize the risks on a risk
• Writing a risk management policy with indicators map/organizational dashboard or domain list as
and objectives shown in Table 6.3. Measuring, quantifying, com-
• Evaluating and describing the external
paring, and prioritizing risks are the next steps.
environment and internal environment
• Identifying risk owners within the organization
with assigned accountability and responsibilities
• Developing an organization-wide risk management plan Measuring Risk
• Allocating resources
• Establishing internal communication mechanisms In Chapter 33 we provide several examples of
• Developing an external communication plan surgical risk and describe the technique of mea-
• Making the risk management process part of the surement for individual risk parameters based on a
organization’s management approach and culture failure mode effect analysis (FMEA). A standard
6 Enterprise Risk Management in Healthcare 69
Table 6.3 Sample risk domains

Risk domains Description Examples Key risk indicators
Operational • Risks resulting from • Failure to diagnose • Number of active lawsuits
failed processes or • Insufficient discharge • Readmission rate
systems planning
• Poor maintenance of • Average age of plant/equipment
equipment or facility
Clinical/patient safety • Risks associated • Inconsistent clinical • Patient satisfaction with clinical
with care delivery appointment process appointments
• Failure to monitor • Reappointment failure rate
reappointment
• Failure to appropriately • Complication rates associated
credential new with new technology
technology procedures
• Failure to monitor • Patient survey—perception of
patient complaints safety within the hospital
Strategic/external • Risks associated • Competition • Market share of major service
with strategy and lines
the direction of the • Relationships with • Physician turnover
organization physicians
• Regulatory changes • Physician and staff satisfaction
survey results
Financial • Risks and decisions • Payment system • Days cash on hand
associated with the changes
financial stability of • Access to capital • Expense per adjusted discharge
the organization • Revenue • Long-term debt to capitalization
enhancement • Operating and total margins
Human capital • Workforce-related • Disruptive behavior • Delinquent chart rate
risks • Hiring and retention • Employee turnover
• Physician shortage • % of RNs contracted through
agencies
• Organizational • State medical school retention
change rate for in-state residencies
• Leadership change/year
Legal/regulatory • Risks associated • ACO issues • Total cost of care
with failing to • HIPAA, FTC issues • Annual legal expenses
understand and • Conflicts of interest
monitor legal and
• ACA issues
regulatory mandates
and laws
Technology • Risks associated • IT/EHR issues • EHR downtime episodes/month
with monitoring,
managing, and • Robotics and • Robotic complication rate
understanding all of certification
the technology used • Multiple vendors • Number of vendors for specific
by the organization service lines/implants/
procedures
Hazard • Risks related to • Natural disaster • Monthly disaster plan review
hazards causing rate
business • Failure to plan for • Number of crisis mock exercises
interruption or crisis contingencies per quarter
major catastrophe • Failure to provide
with effects upon redundancy and
patient care delivery backup systems
and safety
ACA affordable Care Act, ACO accountable care organization, EHR electronic health record, FTC Federal Trade
Commission, HIPAA Health Insurance Portability and Accountability Act, IT information technology
Fig. 6.1 Calculation of Risk Score
Fig. 6.2 Rating scales for calculating Risk Scores
FMEA utilizes three parameters to calculate a risk although various data sources may certainly be
priority number (RPN) for each risk identified. used to improve accuracy in making the esti-
The three factors are frequency of occurrence, mates. Risks with higher Risk Scores, or those
severity, and likelihood of detection. Although above a given threshold value, may then be care-
this rating system works well in the clinical set- fully evaluated and monitored.
ting, most organizations with formal ERM sys-
tems utilize a simpler version with only the
parameters of frequency (likelihood) and severity Culture
(impact) to derive a Risk Score that typically is in
the range of 1–100 (in the case of a scale of 1–5 The culture of an organization is of immense
rather than 1–10 for each factor, the range would importance, and developing a great culture focused
be 1–25). Scales of 1–5 for each parameter are on improving patient safety and quality is para-
easier to use and make decisions while scales of mount to success. A major component of a just
1–10 afford more precision and are preferred in culture in healthcare is trust. Without trust among
engineering work (Figs. 6.1 and 6.2). peers, subordinates, clinicians, providers, and
After the risks have been categorized and administration, many healthcare organizations
listed using a risk domain, a Risk Score is will merely go through the motions and never
assigned to each specific risk identified. For achieve true quality improvements. Healthcare
example, the risk of failure to appropriately cre- organizations, and hospitals in particular, are often
dential new technology procedures may be highly political with poor lines of communication
assigned a frequency score of 2 (since the creden- among various departments, and may harbor ten-
tialing is usually done correctly) and a severity sion between administration and those clinicians
score of 6 (because the patient safety risk and that serve the needs of the patient. Individuals at
liability may be high if a mishap occurs involving varying levels within the organization may have
a provider who has not been credentialed appro- personal agendas that impact honest communica-
priately). The Risk Score in this case would be tion and limit the sharing of information that
12. Risks may be scored using this system and would enhance higher quality and patent out-
they can then be grouped and compared. The comes. One noted hospital turnaround executive,
numbers assigned to each risk are estimates when asked how he had been so successful with
derived by the team performing the assessment, institutions that struggled to provide good results,
stated, “It’s simple. When faced with any decision Avoiding a Culture of Fear
I always ask if this action will improve servicing
the needs of the patient and improve quality. If the One barrier to improved patient outcomes and
answer is no, then we don’t do it.” quality has been the pervasive culture of fear in
Communication and trust must drive culture many organizations that usually stems from a
with an unwavering focus on the needs of the patient combination of a strict clinical hierarchy and the
[5]. If a policy or procedure does not improve threat of litigation. Unfortunately, this culture of
patient outcomes, then it shouldn’t be adopted. In fear has been fairly common in healthcare.
many instances, the larger and more complex the Concerns over patient privacy, reputational risk,
organization, the more the tendency to focus on and cost of litigation in both settlement value
organizational rather than customer (i.e., patient) and impact on medical malpractice premiums
needs. As healthcare moves to increased transpar- have stifled open communication and learning
ency and disclosure of both quality and costs, [9]. Such concerns also inhibit reporting of near
patients will demand higher quality services at a misses, which are critical for an organization to
lower cost in the new retail environment. The orga- study in order to learn and improve [10]. Tort
nizations that can make significant improvements in reform and reduced frequency and severity of
patient outcomes will have the upper hand in attract- claims have improved the market conditions
ing and retaining patients. This will not be accom- and availability of medical malpractice insur-
plished without breaking down the communication ance over the past several years. Consequently,
barriers and increasing trust through a broader there is an opportunity to break this cycle of fear
enterprise-wide risk management structure. and communicate appropriate information in
Risk is inherent in every business, and organi- order to improve both patient experience and
zations that embed risk management practices outcomes.
into business planning and performance manage- Some healthcare organizations avoid any dis-
ment are more likely to achieve their strategic and cussions involving errors or mistakes that take
operational objectives [6]. Healthcare is often place in the hospital setting for fear of discovery
characterized by the statement, “good people, bad in a litigated matter [11]. As a result, they may
system.” Frequently the “system” (administration, not always be forthright with patients and rela-
politics, bureaucracy, regulations) gets in the way tives regarding the specifics of the event that
of individuals doing their job or doing the right occurred. Communicating, studying, and under-
thing when it is needed. The ERM processes standing what went wrong benefit everyone and
should include both identifying issues that get in lead to higher patient quality in the future [12].
the way of better quality and patient outcomes Effective apologies, experts tell us, are those
and documenting situations in which successful that are made as quickly as possible after the
workarounds occurred to avoid a bad outcome. event, and should occur within 24 h to be effec-
Due to incident reporting mandates, there is often tive [13]. There has been interest in such pro-
a focus on bad outcomes with limited learning grams as “Sorry as a strategy,” and related “I’m
about what was done correctly [7]. The true learn- sorry” legislation that has evolved over the last
ing that should be taking place to improve quality 10 years. These strategies have created progress
comes from the avoidance of a bad outcome or towards breaking the culture of fear, but only if
“near miss,” with appropriate recording of the implemented on an enterprise-wide basis, since
events and subsequent follow-up using an organi- they will not be as effective and could poten-
zational structure such as a morbidity and mortal- tially be more damaging when applied inconsis-
ity conference. A number of organizations have tently [14, 15].
utilized various programs supporting a culture of Investing in an enterprise-wide risk manage-
ERM, including Organizing for High Reliability ment strategy can be time consuming and
(HRO), Crew Resource Management (CRM), and involves a significant investment for many orga-
TeamSTEPPS (from AHRQ) [8]. nizations. A comprehensive risk program is a
wise investment for an organization interested in ing a culture of safety is to study the current state
improving quality, lowering costs, and reducing of an organization utilizing a risk assessment. If
risks for the patients it serves. an organization is indeed defined by its culture,
harnessing that culture requires understanding the
culture through two lenses: vertical alignment and
Defining a Culture of Prevention horizontal alignment. That means evaluating
leadership all the way from the CEO down to the
Much has been written about the complexities of managerial level, and then performing a horizon-
understanding and establishing a culture of safety. tal examination of each through a common
This concept is illustrated by the onion model of framework.
Schein adapted as the Helsinki Onion and the The following case study uses a four-dimension
Culture of Prevention [16]. One can immediately framework: just culture, organizational structure,
appreciate the complexity surrounding the path to engagement, and alignment measures. Nested
building a culture that moves “from risk to a zero within the four dimensions are 21 analysis mea-
incident organization.” A safety culture is defined sures, including measures from just culture, ethics,
as “the ways in which safety is managed in the leadership, and staff attitudes and behaviors. The
workplace, and often reflects the attitudes, beliefs, analysis measures provide an assessment of how
perceptions and values that employees share in well the staff feel they are delivering high-quality
relation to safety” [17]. The first step in establish- and safe care to the patients. Figure 6.3 illustrates
fety
Emplo r
Behav
nt Sa
yee
Ju
re
io
Patie
Ca
st
Cu
nt
tie
ltu
Pa
83 69
re
Et 74
hic 68
s
Just gy
Culture ate
70 Str
Contin 73 76
Impro uous
veme
nt 69
Employee
Alignment Organization
Good Processes Survey
72 69 72 I get along
71 76
72
nology
Tech Engagement 66
63
70 Le Sen
ship 66 ad io
er 67
74 er r
ad 65 sh
Le 69 ip
71 77 68 70
s
rtu th
ns
Co
tie
po row
tio
ni
Lin
W
tion
op G
My Iupervis
ica
or
Empoawned
eo
Accounta
organization
S
Pride in the
ke
n
un
ora
vatio
fs
mm or
rs
mm
lab
igh
Co
edia
Inno
t
Col
rment
bility
te
Fig. 6.3 The employee survey and four-dimension framework: just culture, organizational structure, engagement, and
alignment measures
the important cultural measures of this hospital of patient safety. The following two figures
study. The findings of our survey suggest that a illustrate the tangible impact on employee
fundamental set of behaviors must exist before perceptions, culture, and patient safety perfor-
operational actions will have any significant mance when people perceive that there has
impact in implementing a culture of safety and been “A Great Deal” of improvement or
prevention. “Not Really/No Change” (Figs. 6.4 and 6.5).
The 103 respondents that voted “A Great
1. A Culture of Prevention is more easily Deal” of improvement showed remarkable
established when leadership first creates a scoring results (80 and above is green) against
culture of “continuous improvement.” all 21 culture measures (Fig. 6.4). Contrast
The question which was asked in the study: that to the findings illustrated in Fig. 6.5 where
“Compared to last year, we have made 49 respondents voted “Not Really/No
improvements in serving our patients and in Change” to the same question. Scores of 55
patient safety.” and below are red, and it is worth noting the
• 35 % of respondents answered: “A Great low scores on Patient Care and Patient Safety
Deal” in the just culture dimension.
• 36 % of respondents answered: “Somewhat” 2 . A culture of prevention is enhanced when
• 17 % of respondents answered: “Not there is a caring culture.
Really/No change” The question asked in the study: “My immedi-
Continuous improvement could be an impor- ate supervisor cares about my personal growth
tant strategic objective in developing a culture and development.”
fety
Emplo r
Behav
nt Sa
Ju
re
yee
Patie
io
st
Ca
Cu
nt
tie
ltu
Pa
89 87
re
Et
hic 85 87
s
Just gy
ate
88 Culture Str
Contin 92
Impro uous 87
veme 88
nt
Employee
86 Alignment Organization
Good Processes Survey I get along
86 89 89
88
y 84
nolog
Tech 85
85 Engagement
Le Sen
s hip 88
89
87
ad io
er r
er sh
ad 87 87 ip
Le 89 91
s
88 89
Co
rtu th
ns
93
tie
po row
tio
ni
Lin
W
My I ervisor
tion
op G
ica
or
organization
Empowned
eo
Sup
Pride in the
ke
Accounta
n
un
ora
mm
vatio
rs
fs
mm
lab
igh
edia
a
Co
Inno
Col
t
rment
te
bility
Fig. 6.4 Respondents that voted “A Great Deal” of improvement (n = 103)

fety
Emplo r
Behav
nt Sa
yee
Patie
re
Ju
io
Ca
st
Cu
nt
tie
ltu
75 51
Pa
re
Et
hic 45 49
s Just
gy
Culture ate
Contin 47 Str
Impro uous 55 52
veme
nt 40
49 Employee
Good Processes Alignment
Survey Organization
47
49 53
64 I get along
58
no logy
Tech
39 Engagement
ip 43 47 44
rsh
ad
e 44 Le Sen
47 63 ad io
Le 44 51 40 er r
ica s
rtu th
44 45
tie
sh
ion
po row
ip
ni
Co
tion
t
op G
Lin
My Imm isor
Empowerment
organization
Accountability
Pride in the
W
un
n
ora
Superv
eo
vatio
or
m
ke
llab
m
fs
and
rs
Co
Inno
igh
Co
ediate
Fig. 6.5 Respondents that voted “Not Really/No Change” in response to question of making improvements (n = 49)
• 57 % of respondents answered: “Yes” • Our senior leadership manages the

• 25 % of respondents answered: “Not Sure” facility extremely well 67
• 10 % of respondents answered: “No” 2. A Shared Vision
Table 6.4 lists the top ten scores in the study of • Our senior leadership has a clear vision
people who perceive that their managers care that has been articulated and well
about their growth and development. The defined 68
behavior scores that are core to patient care 3. Corporate Culture That Motivates and
and safety rank at the top, and pride of employ- Promotes Change
ment has the strongest score. Managers who • Our facility has an entrepreneurial
care about their workgroups have workgroups spirit-supporting people in coming up
who are proud to work for the organization with new and fresh ideas 69
(Figs. 6.6 and 6.7). • The doctors, nurses, and administration
3 . A culture of prevention is enhanced when work in harmony as a united business
there is leadership excellence. unit 67
The following are six commonly recognized 4. Honest and Timely Communication
leadership qualities that need to be present in • I can speak openly and truthfully about
the minds of the employees for any successful business or patient issues to anyone in
change. In this case study the survey answers the organization 65
are in italics following each of the six leader- • I feel that our senior leadership openly
ship qualities and the numbers in red indicate and honestly works with the staff to
overall scores of the client organization. improve our workplace 68
1. Top Management Sponsorship 5. Ownership of Change by Middle
• I feel that our senior leadership openly Management
and honestly works with the staff to • When something goes wrong, we cor-
improve our workplace 68 rect the underlying reasons, or “root
Table 6.4 Top scores of employees who feel that managers care about their growth and development
No. Factor Item Score
1 Employee behavior Nurses should always question decisions made by an attending if they 93
perceive a problem with patient care or safety
2 Pride in the organization I am proud to work for this facility 93
3 Employee behavior I would report at-risk patient safety behavior from any of my coworkers 92
to my immediate supervisor
4 My immediate supervisor My immediate supervisor values me 92
5 My immediate supervisor My immediate supervisor cares for me 92
6 My immediate supervisor My immediate supervisor constantly promotes patient safety as a core value 90
7 My immediate supervisor My immediate supervisor has the necessary skills to lead me 89
8 I get along I trust and get along with coworkers in my work unit 89
9 Pride in the organization If a friend was seeking employment, I would wholeheartedly recommend 89
this medical center as a great place to work
10 Pride in the organization I have a bright future working in this facility 89
fety
Emplo r
Behav
nt Sa
Ju
re
yee
io
Ca
Patie
st
Cu
nt
tie
ltu
Pa
87 80
re
Et
hic 79 82
s
Just gy
ate
Contin 83 Culture Str
86
Impro uous 82
veme
nt 81
Employee
Good Processes 81 Alignment Organization
Survey I get along
80 84 85
83
gy 79
nolo
Tech
78 Engagement 81
ip Le Sen
85 ad io
rsh 83 er r
a de 80
84 sh
Le 82 ip
84 90
s
s
rtu th
82 90 85
Co
tie
n
po row
tio
ni
Lin
W
My I ervisor
ica
op G
tion
or
organization
Empoand ility
eo
n
Sup
Pride in the
un
ke
Acco
vatio
ora
mm
mm
rs
fs
lab
igh
edia
Co
werm
Inno
untab
Col
t
te
ent
Fig. 6.6 Respondents who felt that their immediate supervisor cares about their personal growth and development
(n = 167)
cause,” so that the problem will not The leadership scores recorded in this
happen again 68 study were low and indicate that leadership
• I believe that leadership and my immedi- must work to improve the scores in order to
ate supervisors are on the same page 67 successfully implement a culture of pre-
6. Employee Involvement vention at this hospital (Table 6.5). Seven
• If I have a great idea and it’s within the senior leadership strategic competencies
facility guidelines, I feel free to act on it 69 were measured in the risk assessment.
ety
Emplo r
Behav
t Saf
yee
n
io
Ju
Patie
st re
Cu t Ca
ltu
re 73 44 t ien
Pa
Ethic 37 49
Just
s
Culture
36 gy
Contin
49 Strate
46
Impro uous 35
veme
nt
Employee
Alignment Survey
Good Processes 43 38 Organization
39
43
56 I get
alon
53 g
y
olog Engagement
Techn 24 33
25 30
ip 32
ers
h 33 36 58 Le Sen
ns
41 29 23 27
ca s
d ad io
n h
un itie
a
tio
er r
rtu wt
Le
tion
sh
po ro
Co
Lin
ip
op G
organization
n
Pride in the
Empowerment
ora
Accountability
vatio
Wo
My Imme or
e of
m
Supervis
llab
m
rke
and
Co
Inno
sigh
Co
rs
diate
Fig. 6.7 Respondents who did not feel that their immediate supervisor cares about their personal growth and develop-
ment (n = 28)
Table 6.5 Senior leadership scores

main responsibilities associated with the posi-
Our senior leadership has a clear vision that has 68
been articulated and well defined tion include:
Our leaders always demonstrate that safety and 76
patient care is their overriding value and priority • Developing the risk framework with risk
I believe that the senior leadership is concerned 71 domains
about the well-being of the employees • Identifying, monitoring, and managing poten-
Our senior leadership manages the facility 68 tial emergent risks
extremely well
• Identifying risk drivers and key risk indicators
I feel that our senior leadership openly and honestly 68
works with the staff to improve our workplace • Utilizing data models to describe and quantify
I believe that leadership and my immediate 66 risk across the organization
supervisors are on the same page • Describing how risk principles fit into and
Senior leadership acts consistently with the 70 affect the overall business strategy and strate-
medical center’s stated values gic plan of the organization
Success of the CRO is measured by demonstrat-

Role of the Chief Risk Officer ing reduced risk throughout the organization
while putting in place mechanisms to change the
Many organizations have established the posi- culture by ensuring more open communication
tion of chief risk officer (CRO) with a responsi- and implementation of a system to support report-
bility for oversight of the entire enterprise. The ing of errors and near misses [18].
edicolegal Aspects of Patient

M incidents in 2015 involved “rogue” employees [20].
Safety Many organizations have resorted to a back-to-
basics approach focused on people, processes, and
Healthcare reform has made population risk man- technology and view the function of security as a
agement a necessity for payers and providers strategic enabler of new initiatives.
[15]. A focus on lower costs and better population
health has created incentives and challenges for
both parties. Health plans and payers face pres- nderstanding Health Information
U
sure to control costs, manage risk, and improve Privacy
quality of care. Today, new value-based health-
care models such as accountable care organiza- The Health Insurance Portability and Accountability
tions (ACOs) are increasing the need for payers to Act (HIPAA) Privacy Rule provides federal protec-
measure provider performance and manage popu- tions for individually identifiable health informa-
lation health at the same time. tion. Currently, the Privacy Rule is balanced to
Payers look at broader, aggregate data to permit the disclosure of health information needed
determine overall pricing on the population they for patient care and other important purposes. The
are insuring and adjust rates accordingly based rule specifies a series of administrative, physical,
on experience and acuity. Although many surgi- and technical safeguards for covered entities and
cal procedures are of higher risk and more costly their business associates to use to assure the confi-
for health insurance companies, the companies dentiality, integrity, and availability of electronic
still rely on actuarial projections for these pro- protected health information [21].
cedures and frequently seek out best practices
from provider networks. To manage populations
and new risk pools effectively, payers as well as Entities and Business Associates
providers will require enhanced clinical capa-
bilities and sophisticated data analytics [19]. The HIPAA Rules apply to covered entities and
business associates. Individuals, organizations,
and agencies that meet the definition of a covered
Information Technology/Security/ entity under HIPAA must comply with the rules’
HIPAA requirements to protect the privacy and security of
health information and must provide individuals
Emerging threats from recent data breaches at major with certain rights relative to their health informa-
US organizations raise questions about the effec- tion. If a covered entity engages a business associ-
tiveness of current security tools and approaches. ate to help it carry out its healthcare activities and
Over the past decade, tens of billions of dollars have functions, the covered entity must have a written
been spent by private and public enterprises to bol- business associate contract or other arrangement
ster security; yet preventing malicious attacks has with the business associate that establishes specifi-
not always been successful. In addition to busi- cally what the business associate has been engaged
nesses, one-third of all Americans have had their to do. It also requires the business associate to
personal health information (PHI) compromised comply with the rules’ requirements to protect the
since 2010. This does not include unreported privacy and security of protected health informa-
breaches. Seven of the ten largest healthcare data tion. In addition to these contractual obligations,
breaches in 2015 were hacker attacks affecting business associates are directly liable for compli-
approximately 92 million individuals. Healthcare, ance with certain provisions of the HIPAA Rules.
at 43 % of reported data breaches, has the highest If an entity does not meet the definition of a cov-
percent for the third straight year. Twenty percent of ered entity or business associate, it does not have
Table 6.6 Examples of covered entities HITECH to perform periodic audits of covered
A healthcare A healthcare entity and business associate compliance with the
provider A health plan clearinghouse HIPAA Privacy, Security, and Breach Notification
Doctors Health Entities that Rules. The HHS Office for Civil Rights (OCR)
insurance process
enforces these rules, and in 2011, OCR estab-
companies nonstandard
health lished a pilot audit program to assess the controls
information and processes covered entities have implemented
they receive to comply with them. Through this program,
from another
OCR developed a protocol, or a set of instruc-
entity into a
standard (i.e., tions, and then used it to measure the efforts of
standard 115 covered entities. As part of OCR’s continued
electronic commitment to protect health information, the
format or data
office instituted a formal evaluation of the effec-
content), or
vice versa tiveness of the pilot audit program [23].
Clinics HMOs
Dentists Company
health plans ase 1: A Children’s Hospital Fined
C
Chiropractors Government $40,000 for Data Breach
programs such
as Medicare,
Medicaid, and
In May 2012, an unencrypted, children’s hospital-
veterans’ issued laptop was stolen from a physician who
programs was presenting at a conference. The physician had
Nursing homes recently received an e-mail from a colleague
Pharmacies containing the protected health information of

Psychologists approximately 2100 patients, 1700 of which were
under 18 years old. The PHI included names,
birth dates, diagnoses, procedures, and dates of
surgery. Although the physician “took steps that
to comply with the HIPAA Rules. See definitions he thought were adequate to remove the protected
of “business associate” and “covered entity” at 45 health information from the laptop,” the informa-
CFR 160.103 [22]. A “covered entity” is defined in tion remained on the computer, according to a
Table 6.6. news release. The children’s hospital agreed to
settle data breach allegations for $40,000 and to
take steps to prevent future security violations,
ffice for Civil Rights Pilot Privacy,
O according to the attorney general of the state
Security, and Breach Notification involved [24].
Audit Program
Use of new health information technologies con- ase 2: Academic Medical Center
C
tinues to expand and provide many opportunities Fined $1,500,000 for Deficiencies
and benefits for consumers. Nevertheless, these in HIPAA Compliance Program
technologies pose new risks to consumer privacy.
Due to these increased risks, HIPAA and the A large urban university recently agreed to settle
Health Information Technology for Economic potential violations of the HIPAA of 1996 Privacy
and Clinical Health Act (HITECH) include and Security Rules, including a $1,500,000 mon-
national standards for the privacy of protected etary settlement and corrective action plan to
health information, security of electronic pro- address deficiencies in its HIPAA compliance
tected health information, and breach notification program. In September of 2010, the HHS OCR
to consumers. The HHS is also required by received notification from the hospital regarding a
breach of unsecured electronic protected health the DOJ for investigation. The OCR reviews the
information (ePHI). On November 5, 2010, HHS information, or evidence, that it gathers in each
notified the hospital of HHS’ investigation regard- case. In some cases, it may determine that the cov-
ing the hospital’s compliance with the Privacy and ered entity did not violate the requirements of the
Security Rules promulgated by HHS pursuant to Privacy or Security Rule. If the evidence indicates
the administrative simplification provisions of the that the covered entity was not in compliance,
HIPAA of 1996. The HHS investigation indicated OCR will attempt to resolve the case with the cov-
that the hospital failed to conduct an accurate and ered entity by obtaining information on voluntary
thorough risk analysis that incorporates all infor- compliance, corrective action, and/or resolution
mation technology (IT) equipment, applications, agreement. Most Privacy and Security Rule inves-
and data systems utilizing ePHI, including the tigations are concluded to the satisfaction of OCR
server accessing NYP-ePHI. It was also alleged through these types of resolutions. When com-
that the hospital failed to implement processes for pleted, the OCR notifies in writing the person who
assessing and monitoring IT equipment, applica- filed the complaint and the covered entity of the
tions, and data systems that were linked to NYP resolution result [26].
patient databases prior to the breach incident and
failed to implement security measures sufficient
to reduce the risks of inappropriate disclosure to Security Risk Assessment
an acceptable level [25].
The Security Risk Assessment is critical. It is one
of the first things Centers for Medicare and
ow the OCR Enforces the HIPAA
H Medicaid Services (CMS) or OCR asks for in an
Privacy and Security Rules audit. Risk assessment should be a fundamental
part of the overall security management program.
The OCR is responsible for enforcing the HIPAA During a Meaningful Use (MU) audit, CMS will
Privacy and Security Rules (45 C.F.R. Parts 160 ask for a copy of the entity’s risk analysis com-
and 164, Subparts A, C, and E). One of the ways pleted before or during the attestation period.
that OCR carries out this responsibility is to However, during a breach of PHI investigation,
investigate complaints filed with it. The OCR OCR will request a copy of the entity’s risk analy-
may also conduct compliance reviews to deter- sis from the previous 6 years. Complying with
mine if covered entities are in compliance, and it HIPAA is serious business. The audits examine key
performs education and outreach to foster com- areas of HIPAA compliance, especially those prob-
pliance with requirements of the Privacy and lem areas pinpointed during OCR’s breach investi-
Security Rules. This office also works in con- gations, such as a lack of comprehensive, timely
junction with the Department of Justice (DOJ) to risk assessment, and mitigation. A comprehensive
refer possible criminal violations of HIPAA. approach to risk assessment controls will help pre-
The OCR may only take action on certain com- vent, identify, and respond to a data breach. There
plaints. If OCR accepts a complaint for investiga- must be thorough vulnerability scanning and pen-
tion, it will notify the person who filed the complaint etration testing. Log and event monitoring and
and the covered entity named in it. Then the com- social engineering data are vital [27].
plainant and the covered entity are asked to present
information about the incident or problem described
in the complaint. The OCR may request specific usiness Associates and Risk
B
information to get an understanding of the facts, and Assessments
the covered entities are required by law to cooperate
with complaint investigations. Business associates (BA) that have not performed
If a complaint describes an action that could be a security risk assessment and do not have an
a violation of the criminal provision of HIPAA (42 appropriate security program in place are a risk to
U.S.C. 1320d-6), OCR may refer the complaint to their organization. Steps to decrease the likelihood
of a breach by an entity’s business associates • Shared IDs and passwords: Many physicians
include the following: and staff don’t truly understand their personal
liability. Problems are passive education, lack
• Prioritize risk of BAs based on services proof awareness, and lack of access to provision-
vided and use/storage of ePHI. ing. Unused legacy or archived systems,
• Request that higher risk BAs provide evidence multiple administrators of websites, and only
of risk assessment. one ID for the hospital are concerns.
• In the absence of a risk assessment, ask BA for a • Personal e-mail: For personal e-mail, all
Service Organization Control report or anything employees and all physicians (employed or not)
that will show that the BA has its own HIPAA should have an exchange account for e-mail.
Security Program in place and would not be Antivirus tools don’t address today’s malware.
found in willful neglect during a breach audit. Problems occur when medical devices sup-
• Consider the policy for BAs that provides ported by clinical engineering are on an old,
high-risk services and does not provide evi- unsupported server. Other concerns are phish-
dence of a current security risk assessment. ing, e-mail harvesting, and ransomware.
• Unattended legacy systems: Include shared
data, open database links related to report
Common CMS Audit Findings writing, and administrative IDs.
• Forgotten items: Forgotten items are old EHRs,
The most common audit findings are lack of dis- financial data, decision support systems, and
seminated policies and procedures. Unencrypted backups. Conversion to data on shared drives,
mobile or removable devices, shared IDs, and pass- a product of hospital IT evolution, may seem
words, texting, e-mail, and mobile apps are common like a good idea but may be hazardous.
vulnerabilities found in audits. Another common • Shared drives: There are often thousands of
issue is unattended legacy systems and shared drives. unencrypted files found on shared Word and
Excel drives that pose a security risk to the
organization.
olicies and Procedures: Problem
P
Areas
he Evolving Role of the Risk
T
• IT risk management program: All facilities Manager
must have an IT risk management program.
Often these are found to be either missing, Once an organization has decided to invest in an
incomplete, or disconnected from the compli- enterprise-wide risk strategy, one of the chal-
ance office. lenges is to identify the appropriate team leader
• Policies: There are currently too many weak for the role. In our experience, the risk manager
or missing HIPAA security policies. Zero tol- has a wide variety of responsibilities, and in
erance is expected for future audits. many instances the role is uniquely defined by
• Procedures: Many procedures still lack peri- the risk profile of the organization or the report-
odic monitoring designed for early detection ing relationship to those having responsibility
of problems. for the function. The healthcare risk manager
• Mobile and removable devices: Lack of can mean different things to different organiza-
encryption is a serious problem and is respon- tions, with the job of managing the following
sible for many security breaches. Encryption three primary functions of risk management:
is important in this area.
• Inventory: RFID and Lo-jack-type firmware • Risk mitigation (safety and loss prevention)
are helpful assets for achieving accurate • Risk financing (insurance procurement)
accounting of your essential inventory and • Claims/litigation management (both insured
change control. and self-insured)
Reporting relationships and position in the organi- shared learning and enhance quality and safety
zational chart directly impact the level of author- nationally. Hospitals and other providers can take
ity, involvement, and trust that these senior risk full advantage of PSOs and the NPSD by:
executives will enjoy. Traditionally, risk managers
have reported through legal, finance, administra- • Joining a PSO to be part of a privileged, pro-
tion, operations, and sometimes even directly to tected, and confidential environment for anal-
the CEO. The position within the organization will ysis of patient safety and quality information
have a direct impact on how “enterprise-wide” the in all healthcare settings
role truly is, since access to information, general • Agreeing to release non-identifiable patient
communication, and accessibility to key senior safety event data for analysis at the national
executives is critical. The actual role of the health- level
care risk manager varies as much as the individual • Using feedback from PSOs and the NPSD to
skills and job description. One overriding common guide patient safety and quality interventions
theme among all healthcare risk managers is that and identify areas for further improvement
each day provides a new challenge. The various
skills required include those of a crisis manager, The Patient Safety and Quality Improvement Act
patient advocate, physician intermediary, accoun- of 2005 and the Patient Safety Rule established a
tant, therapist, and actuary. framework by which information voluntarily
Important and far-reaching changes have been reported or discussed by doctors, hospitals, and
felt throughout the healthcare industry, and the other healthcare providers regarding patient safety
role of the risk manager continues to evolve in events and quality of care is protected from dis-
order to manage these trends. The acquisition of closure. The Act provides specific legal protec-
provider groups by hospitals and the integration tions for privileged and confidential event-level
of provider networks to offer broader population data voluntarily submitted by healthcare provid-
health management to the community have served ers to PSOs and allows shared learning to enhance
as an impetus for further evolution of the risk quality and safety nationally. The Agency for
manager role. Healthcare risk managers must be Healthcare Research and Quality (AHRQ) is
deeply involved with the merger and acquisition establishing the NPSD to serve as a resource for
function not only from a due diligence standpoint, healthcare providers and PSOs to analyze and
but also in supporting the integration of the newly learn about threats to patient safety and how to
acquired organization which often will have dif- avoid them. Patient safety event data go through
ferent systems, policies, procedures, and culture. multiple steps in the processes of de-identification,
In view of the diverse skill sets required of the analysis, and reporting of meaningful results for
risk manager, we believe that the demand for a patient safety improvement. Key players in the
truly qualified healthcare risk manager capable of analysis process are the following:
operating at an enterprise level across the various
functions of an organization will only increase in • PSOs: Entities that can be public or private
years to come. organizations, to collect, aggregate, and ana-
lyze information regarding the quality and
safety of care delivered in any healthcare set-
ormal Risk Reporting and Risk
F ting. The Act extends legal privilege and con-
Data Management fidentiality protections to healthcare providers
who voluntarily submit patient safety event
Patient safety event reporting and quality data can information to PSOs. Hospitals and other
help your organization improve its healthcare healthcare providers may voluntarily submit
delivery. To help healthcare organizations improve patient safety event-level data to PSOs on a
patient safety, Congress established patient safety privileged and confidential basis for the
organizations (PSOs) and the Network of Patient aggregation and analysis of patient safety
Safety Databases (NPSD) as resources to promote events. PSOs analyze the data and provide
feedback to the submitting healthcare provid- the external experts that collect and review patient
ers. PSOs also provide a protected space for safety information [29].
members to discuss patient safety and quality
topics. AHRQ is responsible for officially
listing PSOs. nderstanding Patient Safety
U
• PSO Privacy Protection Center (PSOPPC): Confidentiality
The Patient Safety Act authorizes the creation
of a NPSD to which PSOs can voluntarily The PSQIA establishes a voluntary reporting
contribute patient safety and quality informa- system to enhance the data available to assess
tion. The Patient Safety Act and Rule require and resolve patient safety and healthcare qual-
that information be made non-identifiable ity issues. Patient Safety Work Product (PSWP)
prior to submission to the NPSD. The PSOPPC includes information collected and created dur-
is responsible for ensuring the privacy of facil- ing the reporting and analysis of patient safety
ities, providers, and patients by de-identifying events. The confidentiality provisions will
and aggregating patient safety event data improve patient safety outcomes by creating an
before providing the data to the NPSD. All environment where providers may report and
information identifying individual and institu- examine patient safety events without fear of
tional providers, patients, and provider increased liability risk. Greater reporting and
employees reporting patient safety events is analysis of patient safety events will yield
removed. Hospitals and other healthcare pro- increased data and better understanding of
viders that are members of a PSO can autho- patient safety events.
rize the PSOPPC to submit non-identifiable
patient safety event data to the NPSD. With
the advantage of larger report volumes, data
analysis conducted by the NPSD can more
easily identify trends and patterns in incidents, Enforcement of the confidentiality of
near misses, and unsafe conditions; detect patient safety work product is crucial to
contributing factors; and analyze rare patient maintaining an environment for providers
safety events [28]. to discuss and analyze patient safety events,
identify causes, and improve future out-
comes. The enforcement provisions are
atient Safety and Quality
P found at Subpart D of the Patient Safety
Improvement Act of 2005 Statute Rule [26]. The OCR seeks voluntary com-
and Rule pliance with the confidentiality provisions
by providers, PSOs, and responsible per-
The Patient Safety and Quality Improvement Act sons that hold PWSP. They may conduct
of 2005 (PSQIA) establishes a voluntary report- compliance reviews and investigate com-
ing system designed to enhance the data available plaints alleging that PSWP has been dis-
to assess and resolve patient safety and healthcare closed in violation of the confidentiality
quality issues. To encourage the reporting and provisions. If OCR determines that a viola-
analysis of medical errors, PSQIA provides fed- tion has occurred, the OCR may impose a
eral privilege and confidentiality protections for civil money penalty of up to $11,000 per
patient safety information, called patient safety violation. The OCR provides technical
work product. The PSQIA authorizes the assistance to persons seeking to comply
Department of Health and Human Services (HHS) with the confidentiality provisions and
to impose civil monetary penalties for violations public information regarding the adminis-
of patient safety confidentiality. PSQIA also tration of the enforcement program [26].
authorizes the AHRQ to list PSOs. The PSOs are
Common Formats Value to Providers
PSOs are required to collect and analyze data in a The stage has been set, now that PSOs can aggre-
standardized manner. The AHRQ created the gate event-level data, for breakthroughs in our
Common Formats, which are common definitions understanding of how best to improve patient
and reporting formats to help providers uniformly safety. Hospitals and other providers benefit from
report patient safety events and support efforts to participating because they can:
eliminate harm. Common Formats delineate defi-
nitions, data elements, and reporting formats that • Compare results at the national level, across
allow healthcare providers to collect and submit PSOs, and across a larger group of provider
standardized information regarding patient safety types
events. Their purpose is to promote rapid learning • Discover underlying causes of incidents, near
about the underlying causes of risks and harm in misses, and unsafe conditions in healthcare
the delivery of healthcare and to share those find- delivery
ings widely, thus creating a national learning sys- • Seek additional expertise for decreasing events
tem for quality improvement strategies [30]. and improving quality
The AHRQ Common Formats include: • Identify patterns of rare events, supported by
larger report volume
• Definitions of patient safety events and event
descriptions
• Examples of patient safety population reports Patient Safety Evaluation System
• Technical specifications for use by software
developers, PSOs, and data vendors On March 11, 2014, CMS issued the final rule
• A user’s guide that describes how to use the implementing a number of provisions of the
formats ACA, including the provision that hospitals must
• A metadata registry with data element attributes satisfy certain patient safety and quality improve-
ment requirements to contract with a qualified
health plan (QHP) through health insurance
Report Types from the NPSD exchanges. The ACA requires QHPs to contract
with hospitals that have more than 50 beds only if
Organization submit data to the NPSD, and the they meet certain patient safety standards, includ-
data becomes part of a national database that ing the use of a patient safety evaluation system
reports on incidents, near misses, and unsafe (PSES) and a comprehensive hospital discharge
conditions. Reports can be broken out by spe- program. The date for implementation of PSESs
cific types of events and harm levels, such as by hospitals is January 1, 2017 [31].
medication events, falls, pressure ulcers, device A PSES is not the same as an event reporting
mishaps, and health information technology system. An organization’s reporting system may
errors. The NPSD compiles this information into be incorporated into the PSES but the system
aggregated tables and charts showing the num- needs a separation between what information is
ber of reported events organized by circum- protected as non-disclosable PSWP from discov-
stance, impact, and contributing factors. Based erable and disclosable information that is not
on the NPSD analysis, report users will be able protected under the PSQIA. Disclosable informa-
to compare their organization’s pattern of patient tion is usually that information relating to an
safety events with all events reported nation- event with harm that is reported to risk manage-
wide. As participation grows, the NPSD will be ment where there may be legal requirements
able to provide additional breakouts of results by relating to the event. Nevertheless, a copy of the
provider characteristics such as size, specialty, event can still be sent to the PSO where research
and type of ownership. and analysis can be performed on the event. In
such a case all the work done on the case is pro- see value in reporting because they perceive that it
tected PSWP and cannot be disclosed to inter- will not make a difference and do not want to risk
ested parties who do not have business associate having their reputations tarnished. However,
agreements in place with the PSO or the submit- under the PSQIA, the information will go into the
ting organization. PSES and the identity of the provider will not be
disclosed. Therefore, if more organizations par-
ticipate with a PSO, more information will be col-
eporting Preventable Errors
R lected and organizations will become more
or Preventing Preventable Errors? effective in preventing harm rather than underre-
porting harm.
In surgical practice there are more near-miss
events than harmful events to patients [32]. Some
would argue that there are 40-fold more near ederally Listed Patient Safety
F
misses than there are adverse events. Unsafe con- Organizations
ditions and hazardous situations occur hundreds
of times before a sentinel event occurs and is There are a total of 81 PSOs in 29 states and the
reported. In general, professionals do not take the District of Columbia currently listed by the
time to document no-harm events and they do not AHRQ. A healthcare provider can only obtain
always share them with the organization [33]. the confidentiality and privilege protections of
Ideally, what should transpire once an event the Patient Safety Act by working with a feder-
occurs is immediate documentation of the encoun- ally listed PSO. The “Listed PSO” logo is avail-
ter and sharing it with peers and the C-Suite so the able for use by PSOs that are currently listed by
organization can implement preventive action. the HHS Secretary. Healthcare providers con-
Today when every caregiver has a smartphone sidering working with a PSO are advised to
in their pocket, it is possible to document all review this directory to ensure that the entity’s
observations in seconds and communicate unsafe PSO certifications have been accepted in accor-
conditions by taking a photo and recording a dance with Section 3.104(a) of the Patient
description of what needs fixing. This does not Safety Rule.
disrupt the clinician’s workflow and enables real- The “AHRQ Common Formats” logo may be
time communication and learning within the displayed by any organization that is using the
organization. Of course, this workflow needs to Common Formats developed by AHRQ. An
consider HIPAA guidance and constraints. entity does not need to be listed as a PSO to use
the Common Formats and thus display the logo.
The Formats are available in the public domain to
Event Underreporting facilitate their widespread adoption and imple-
mentation. Entities that display the logo should
The Office of the Inspector General (OIG) pub- use the Common Formats as a whole; however,
lished a report stating that only 14 % of docu- entities that have a limited focus may display the
mented events in the medical record that relate to logo when using Common Formats that pertain
patient safety were actually reported to the quality only to that area [30].
department for analysis and process improvement
action [34]. This suggests that 86 % of what is
documented in the medical record as a quality Summary
issue is never addressed for organizational learn-
ing and the prevention of future harm. It has also Enterprise risk management is an important and
been estimated that less than 10 % of all report- complicated discipline which touches all aspects
able events are reported by physicians [35]. This of a healthcare organization. Important concepts
may be due to the fact that many physicians do not related to risk identification and measurement,
culture, and culture assessment are discussed ini- 13. Joint Commission on Accreditation of Healthcare

Organizations. Disclosing medical error: a guide to an
tially. Patient safety and privacy, HIPAA, and
effective explanation and apology. Joint Commission
other medicolegal aspects of risk in the health- Resources. Oakbridge Terrace, IL; 2007, 36p.
care setting are next reviewed in detail. The chap- 14. Cohen JR. Toward candor after medical error: the
ter concludes with a discussion of issues related first apology law. Harv Health Policy Rev. 2004;
51:21–4.
to government programs such as PSOs, PSESs,
15. Cantor M, Barach P, Derse A, Maklan C, Woody G,
and using Common Formats in risk reporting. Fox E. Disclosing adverse events to patients. Jt Comm
J Qual Saf. 2005;31:5–12.
16. Aaltonen M, Vainio H. Foreward. In: Proceedings of
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The Patient Experience:
An Essential Component of 7
High-Value Care and Service
Sara Shaunfield, Timothy Pearman,
and Dave Cella
“We cannot direct the wind but we can adjust the sails.”
—Author Unknown
Abbreviations HCAHPS Hospital Consumer Assessment of

Healthcare Providers and Systems
AAIM Alliance for Academic Internal Medicine HRQL Health-related quality of life
ACP American College of Physicians HVC High-value care
AHRQ Agency for Healthcare Research and NCCN National Comprehensive Cancer
Quality Network
ARRA American Recovery and Reinvestment PCORI Patient-Centered Outcomes Research
Act Institute
CAHPS Consumer Assessment of Healthcare PRO Patient-reported outcomes
Providers and Systems PROMIS® Patient Reported Outcomes Measure
CER Comparative effectiveness research ment Information System
FACIT Functional Assessment of Chronic PROMS Patient Reported Outcome Measures
Illness Therapy SPORT Spine Patient Outcomes Research
Trial
S. Shaunfield, PhD By the year 2020, healthcare expenditures are pro-

Medical Social Sciences, Northwestern University, jected to reach nearly 20 % of the gross domestic
625 N. Michigan Ave., Suite 27, Chicago, product, a spending rate described as highly unsus-
IL 60611, USA tainable by economists. Approximately 30 % of
healthcare costs (over $750 billion annually) has
T. Pearman, PhD, ABPP been identified as wasteful spending that if elimi-
Medical Social Sciences and Psychiatry & Behavioral
Sciences, Robert H. Lurie Comprehensive Cancer nated would not negatively affect care quality [1].
Center of Northwestern University, 633 N. St. Clair, Examples of waste include preventable hospitaliza-
19th Floor, Chicago, IL 60654, USA tion and rehospitalization, overuse and misuse of
e-mail: [email protected] diagnostic testing, and excessive use of emergency
D. Cella, PhD (*) department services [2]. A myriad of factors are
Medical Social Sciences, Northwestern University, influencing rising healthcare costs, including the
Feinberg School of Medicine, 633 N. St. Clair,
19th Floor, Chicago, IL 60611, USA aging population, novel devices, drugs, tests, and
e-mail: [email protected] procedures. However, healthcare innovations are

88 S. Shaunfield et al.
also contributing to improved patient outcomes; called for an overarching strategy to reduce
thus evaluating the value of healthcare services is of healthcare costs by improving value for patients
great importance and necessary for reducing extra- [6]. Within their seminal works, the authors
neous healthcare spending [3]. defined value as patient outcomes relative to the
For decades, efforts to enhance quality and amount of money spent [7–10]. Since Porter and
safety practices and slow the rate of increasing Kaplan’s initial call for systematic change, many
healthcare costs have been undertaken. Due to the healthcare organizations and national institutes
exorbitant spending projections, scholars, organi- have begun to support value-based initiatives and
zations, and practitioners have endeavored to shift are in the process of developing and implement-
healthcare reform efforts from a fee-for- service ing plans for restructuring healthcare organiza-
model to one that places emphasis on the delivery tions and care processes—the ultimate goal being
of high-value care. Value-based health care is a a reconfiguration of the US healthcare delivery
reform effort that aims to control unnecessary system to reduce costs while simultaneously
healthcare expenditures by focusing on the value enhancing quality and efficiency.
of healthcare interventions and services deter- Growing support for value-based health care is
mined by evaluating the costs in light of benefits evidenced by the American College of Physicians
and risks while considering quality care outcomes (ACP) High-value Care (HVC) initiative, a broad
prioritized by patients [4]. Screening protocols, program that aims to enhance physicians’ ability to
procedures, and interventions are now being cho- provide optimal patient care while simultaneously
sen or disregarded based on their ability to produce reducing unnecessary healthcare costs. The goals
good value (medical benefits commensurate with associated with the HVC initiative involve provid-
costs) based upon patient preferences [4]. An inter- ing recommendations to clinicians regarding best
vention is deemed high value when the health ben- available practice, to notify clinicians when evi-
efits justify the costs. The higher the benefit, the dence is lacking, and to assist clinicians in provid-
more justifiable the cost of the intervention that ing the best possible health care [11], including
delivers that benefit. High- cost interventions in development and dissemination of condition-spe-
which the net benefit outweighs the costs could cific recommendations for high-value diagnostic
therefore be considered a good value. Conversely, services [12]. Increasingly, medical professionals
low-cost interventions that provide little to no net are taking on more responsibility to reduce health-
benefits are considered to have low value, in spite care costs by becoming cost-conscious and
of the low price tag [3]. Although the cost of care is decreasing unnecessary interventions that provide
important, value-based healthcare delivery is orga- little to no benefit. The need for training in value-
nized around the patient by aiming to meet a set of based care is further evidenced by a recent proposal
defined patient needs [5]. In short, the objective of to include medical resident training on practicing
high-value care is to improve health outcomes that high-value, cost-conscious care as a seventh core
are important to patients in a cost-effective and competency for physicians by the Accreditation
efficient manner. This chapter provides an over- Council for Graduate Medical Education [2].
view of high-value care, reviews the patient’s role Likewise, in a joint endeavor, the ACP and the
in value-based care, and outlines the integral role Alliance for Academic Internal Medicine (AAIM)
of patient-reported outcomes (PROs) while high- developed an High-value care (HVC) Curriculum,
lighting specific tools for outcome assessment. which aims to help internal medicine residents in
providing value patient care by teaching them how
to identify system-level opportunities to reduce
What Is High-Value Care? wasted costs and improve patient outcomes. In
addition to learning how to balance benefits with
Considerations of restructuring into a value-based potential harms and costs, medical residents
healthcare system began with Porter and Kaplan’s actively learn methods of practicing evidence-
pioneering work at Harvard Business School, and based shared decision making with patients [13].
7 The Patient Experience: An Essential Component of High-Value Care and Service 89
Further, the American Recovery and Reinvestment terms of process measures (e.g., emergency
Act of 2009 (ARRA) allocated over $1 billion to department visits, hospital admissions, readmis-
support comparative effectiveness research (CER), sion rates, mortality rates), safety measures (e.g.,
defined by the Institute of Medicine as “… the gen- medication errors, central line infection rates,
eration and synthesis of evidence that compares the postoperative complications), and patient-reported
benefits and harms of alternative methods to pre- satisfaction [15, 17]. Current standards for out-
vent, diagnose, treat, and monitor a clinical condi- come assessment cover little breadth in terms of
tion, or to improve the delivery of care.” The goal the outcomes that are actually important to
of CER is to promote informed decision making by patients. To enhance value, outcome measurement
consumers, clinicians, purchasers, and policy mak- must include health circumstances identified by
ers to improve healthcare delivery [14]. patients as most relevant to their quality of life [9].
In order to fully comprehend value-based While the above is important when investigating
care, one must first understand the value equa- organizational process outcomes, in order to assess
tion. The value in high-value care is defined as the true value of health care, clinicians must gain
the following: value equals quality over cost or insight into the outcomes that are of concern to
V = Q/C [15]. Cost (the denominator) refers to the patients [18].
economic cost over the full cycle of care for a This is why one of the most emphasized strate-
medical condition, not simply the cost of indi- gies for implementing a value-based care model
vidual services [9, 15]. When conducting value centers on the measurement of health outcomes
and/or cost assessments, health organizations and and costs for each patient over the full cycle of
providers must consider any and all downstream care. Value-based initiatives support outcome
costs (e.g., subsequent testing, treatment, follow- assessment by medical condition rather than by
up, conditions due to treatment complications) in intervention or specialty. In 2010, Porter recom-
the equation [3, 4]. Quality (the numerator) in the mended a three-tier hierarchy for assessing health
equation represents outcomes of importance to outcomes of concern to patients. The hierarchy
patients (e.g., health status, care cycle and recov- tiers include health status achieved, recovery pro-
ery, health sustainability). cess, and health sustainability [17]. The first level
Porter and Kaplan outline a six-component of recommended outcomes include health status
strategy for the effective implementation of a achieved that involves mortality rates and func-
value-based healthcare system: (1) organize into tional status, which are top concerns for patients.
integrated practice units; (2) assess outcomes and The second outcome tier refers to the cycle of care
costs for every patient; (3) bundle payments for and recovery, which includes the level of discom-
care cycles; (4) integrate healthcare delivery sys- fort during treatment, diagnostic errors, delays in
tems; (5) expand geographic reach; and (6) the treatment process, duration of hospital stay,
develop an information technology platform to treatment-related discomfort, complications, adverse
enable and support the above. This chapter events, and the time required to resume normal
focuses on component two as it relates to the activities, including work. The third tier relates to
scope of this chapter—outcomes of importance the sustainability of health including the nature of
from the patient’s perspective (for further infor- recurrences, level of function maintained, and
mation on the other five components, see [16]). long-term consequences of therapy (e.g., care-
Measurement of outcomes and costs is essen- induced illnesses). For further details on the three-
tial to improving value; without these data, clini- tier outcome hierarchy, see Porter [9].
cians do not have the information required to Ideally, patient outcomes will be measured
validate choices, guide advancement, learn from and publicly reported. Public reporting of out-
others, or encourage collaboration and change [5]. comes provides a level of transparency not cur-
To date, our healthcare system does not measure rently available which will benefit patients and
outcomes and costs by medical condition for indi- providers [19]. The publication of condition-spe-
vidual patients. Instead, outcomes are assessed in cific outcomes enables patients to become
informed healthcare consumers armed with herniation patients revealed that both surgical and
choice in deciding a provider, but it also increases nonsurgical groups improved posttreatment;
pressure on providers to adopt best practices and however, patients who received a discectomy
improve care practices based on what actually recovered more quickly [20]. Results of the spi-
matters to patients. The standardization of out- nal stenosis trial uncovered that surgical interven-
come measures by condition will enable com- tion resulted in better pain and function PROs
parisons to be made across providers and than nonsurgical therapies [21]. Likewise, the
organizations which will then stimulate improve- surgical patients in the degenerative spondylolis-
ments in practice and patient outcomes on both a thesis trial reported greater improvements in pain,
national and global scale [16]. Efforts to develop, function, and disability than those receiving non-
standardize, and distribute efficient outcome surgical therapies [22]. For all three conditions,
measures are currently under way and have made the results of a 4-year follow-up study showed
great progress, and will be highlighted later in that patients maintained the reported gains from
this chapter. surgical intervention 4 years after surgery [20, 22,
In its current state, our healthcare system is 23]. Further cost-benefit analyses of longitudinal
unable to assess condition-specific costs for each PRO data on productivity loss, use of resources,
patient for a full cycle of care. Healthcare organi- and health-related quality of life (HRQL) revealed
zations are currently reimbursed on a fee-for- that when assessed over 4 years, surgery provides
service basis and are department based rather good value for patients in the three diagnostic
than patient or condition based. Moreover, health- groups [24]. Currently, the Spine Center at
care accounting systems based on overall depart- Dartmouth-Hitchcock implements these princi-
ment budgeting are unable to provide accurate ples in the practice of spinal care, by conducting
estimates of service costs on a patient or even detailed intake assessment that incorporates
condition level [16]. To ascertain value, it is rec- PROs and visual decision aids, and engages in
ommended that healthcare providers calculate shared decision making with their patients to
costs based on the medical condition over the full develop a personalized plan of care in light of
cycle of care. Tracking expenses incurred over patient priorities to determine whether patients
the full care cycle involve recognizing all are more likely to benefit from nonsurgical thera-
resources utilized to care for the patient (e.g., pies or surgery [25].
equipment, facilities, personnel), capacity costs
of supplying resources, and care-associated sup-
port costs (e.g., administration, IT). Only then can hat Is the Patient’s Role
W
the actual cost of condition-specific care be com- in High-Value Care?
pared with quality (patient outcomes) to deter-
mine the value of healthcare services [16]. Many efforts at healthcare reform have focused
Research conducted within the Spine Center at the structure and design around physicians and
Dartmouth-Hitchcock is a good example of institutions; however, in these efforts, the patient
value-based health care. Dartmouth’s Spine was commonly left out. In 2001, the Institute of
Center conducted a 5-year, multisite study, Spine Medicine’s landmark report, Crossing the Quality
Patient Outcomes Research Trial (SPORT), to Chasm, presented patient-centered care as a fun-
compare the three most common back conditions damental step towards improving US healthcare
(i.e., intervertebral disc herniation, spinal steno- quality. Patient-centered care is defined as “care
sis, degenerative spondylolisthesis) and PROs to that is respectful and responsive to individual
gain insight into whether surgery produces better patient preferences, needs, and values” [26]. The
outcomes over nonsurgical therapies (i.e., physi- report further recommended that patient values
cal therapy, medication, other noninvasive thera- should be considered as guides to all clinical deci-
pies). Results of the trial in intervertebral disc sions. Patient-centered care involves ensuring
that treatment decisions align with the patient’s needed to obtain more information regarding the
values and preferences. When faced with making impact on surgical utilization.
a decision among treatment options, patients Shared decision making has been championed
often experience a state of heightened uncer- as a successful method of enhancing patient- and
tainty, also known as decisional conflict [27]. The family-centered outcomes while reducing waste—
quality of a decision involves the degree in which and therefore is one method of practicing value-
a patient’s decision is congruent with their values based care [27]. The Agency for Healthcare
and evidence-based knowledge. One way to prac- Research and Quality (AHRQ) and the Patient-
tice patient-centered care and to enhance the Centered Outcomes Research Institute (PCORI)
value of health care is to invite patients and fam- both increased funding for research aimed at
ily members to actively participate in clinical developing shared decision making support tools,
decision making in ways that reduce decisional testing implementation, and reporting results [31,
conflict and enhance decision quality. 32]. Likewise, the Informed Medical Decisions
Foundation provides resources and guides to help
patients understand the importance of engaging in
Shared Decision Making shared decision making and information to assist
them in that process [33].
In order to achieve optimal decisions in line with A well-informed patient is one who is both
the patient’s values and preferences, both provid- aware of and understands the potential risks and
ers and patients must engage in a process of shared benefits of diagnostic and treatment options.
decision making [28]. Shared decision making Patients tend to overestimate benefits and underes-
involves active collaboration among patients and timate harms when faced with a choice of treat-
providers for the development of a mutually agreements [34]. These results support the need for
able plan of care [27]. To enhance patient partici- providers to actively engage patients in healthcare
pation in shared decision making, patients need decisions by clearly communicating the benefits
more information, such as guidance for personal- and potential risks associated with different
ized care planning and self-management, resources choices. Clinicians, therefore, have an important
for decision support, and social support from fam- role in encouraging and inviting patients to actively
ily and peers [29]. When given these resources and participate in healthcare decision making; how-
opportunities for active participation, the result is ever, this is not necessarily a straightforward task.
often better health outcomes and reduced waste, Patient understanding is a fundamental com-
resulting from increased participation, better treat- ponent of value-based care. Patient knowledge
ment adherence, more appropriate use of services, and understanding require that clinicians engage
reduced elections for major surgery, more realistic patients in direct discussions of diagnosis, prog-
risk perceptions, improved knowledge and under- nosis, treatment options, and end-of-life care pref-
standing, enhanced self-management and coping erences (e.g., palliative, hospice care) [35]. In
skills, reduced decisional conflict, and greater order to educate patients and engage them in
match between chosen treatments and patient val- shared decision making, providers must be able to
ues and priorities [27, 29, 30]. In fact, shared deci- effectively communicate with their patients. To
sion making was investigated in the context of implement value-based care by engaging patients
elective surgery—the results revealed that shared in shared decision making, physicians must be
decision making improves patient decisions to effective at not only assessing risks, but also com-
undergo elective surgery and helps reduce deci- municating those risks to patients in an intelligi-
sional conflict and overuse of surgical care [27]. ble manner. However, physician competencies in
While the use of shared decision making in elec- communication skills and risk assessment have
tive surgery appears promising, future research is been described as poor and thus require training
to improve their skills in communicating numeri- and ultimately closing the gap between patient
cal information to patients which is necessary if values and choices [36–38]. When outcome prob-
providers are to effectively discuss risks and ben- abilities are included in decision aids (particularly
efits of different treatment options. Patient per- when presented quantitatively) patients have more
spectives and input should be included in efforts accurate perceptions of risk [38].
aimed at enhancing provider communication Decision aids have received support among
skills, especially the skills needed to intelligibly surgeons, although there has been minimal prog-
discuss risk. Inclusion of patient voices in these ress towards incorporating decision aids into stan-
efforts will reinforce the central role of the patient dards of care. Despite the lack of nationwide
in creating value. In value-based health care, progress for integrating decision aids into health-
medical decision making is inherent to value, and care delivery, a few research hospitals are leading
patient understanding of risks versus benefits is the way [36]. One example is the Spine Center and
essential in these efforts [35]. Adult Reconstruction division of the Department
of Orthopaedics at Dartmouth-Hitchcock Medical
Center. Together, this team is working with the
Decision Aids Center for Shared Decision-Making to implement
the use of shared decision making tools into stan-
Decision aids are useful tools that aid physicians dard care by providing orthopaedic patients
in communicating objective information about opportunities to engage in informed choice by
treatment options, ensuring that the patient under- encouraging them to borrow a DVD and take
stands that a decision must be made, and provid- home a symptom-rating worksheet. The work-
ing the patient opportunities to make decisions sheet asks patients questions about their prefer-
about their care, if desired [36]. Decision aids are ences, values, and decisional conflict to aid them
commonly used when more than one option for in choosing the most appropriate treatment option
screening or treatment exists [28]. In addition to [39]. Decision aids, like those utilized by
helping doctors discuss important information, Dartmouth’s Orthopaedics department, provide a
decision aids are also used to help educate patients structure for discussing the benefits and risks of
by informing them of the risks and benefits of treatment options in light of patient priorities and
treatment options and providing them with tai- values. Use of decision aids provides patients a
lored evidence to consider in light of their particu- voice by enabling them to become informed par-
lar condition. Sometimes, decision aids include a ticipants when choosing care options that provide
section aimed at clarifying patient values, which optimal value. In addition to decision aids, sup-
benefits both patients and providers when dis- portive services should be available to aid patients
cussing and deciding upon the most appropriate and families when communicating with clinicians
options based on patient preferences in light of about their preferences and values while they are
evidence-based knowledge [27]. Decision aids learning about, processing, and deciding among
can be delivered through different modalities (i.e., treatment options [28]. Only through communica-
video, online, paper), and are used to enhance tion and understanding of evidence-based knowl-
patient understanding of treatment options and edge can patients have realistic expectations
the potential outcomes and to further assist patients regarding their healthcare options.
in developing and discussing educated prefer-
ences with their clinicians.
Like shared decision making, decision aids arriers to Shared Decision Making
B
provide many benefits including improvements in and Value-Based Care
patient-provider communication and collabora-
tion, information exchange (i.e., risks, benefits, Despite the vast benefits and avenues for enhanc-
options), treatment adherence, patient satisfaction, ing value in health, there are barriers to shared
decision making and barriers to value-based care erations when making healthcare decisions may
implementation efforts for both clinicians and have heightened anxiety, especially in light of the
patients. An investigation into clinician readiness pervasive rhetoric concerning healthcare ration-
to openly discuss high-value care during patient ing. Research into patient perspectives might pro-
and family consultations revealed that although duce different results if interviews are conducted
physicians held favorable views of high-value following a clinical encounter in which the pro-
care, they commonly chose to avoid explicit ref- vider incorporated cost discussions. More qualita-
erences to value in their interactions with patients tive research is needed to investigate patient
[40]. Likewise, while evidence suggests that perceptions of value-based healthcare initiatives
most patients are open to participating in health- and practices. Qualitative methods are a useful
care decision making [27, 29], some groups may approach for learning about patient preferences to
be less open to the idea. For example, disadvan- aid cost-reduction efforts and enhance the value
taged groups and older adults are less likely than of care based on patients’ lived experiences that
young educated adults to report wanting an active influence outcome priorities [42]. Insights gained
role in shared decision making; however, many through qualitative studies will aid researchers,
of the former claim that they would like the clinicians, and policy makers in developing the
opportunity to learn about choices from their most appropriate decision aids, communication
doctors [29]. On the other hand, evidence sug- training for medical practitioners, and protocols
gests that when patients know that they have for sharing information regarding risks and bene-
treatment options, most want to engage with their fits that are based upon patient values. Moreover,
physicians to make an optimal choice [28]. public perceptions concerning cost considerations
Although open communication and transpar- in healthcare decision making must undergo a
ency regarding a need to weigh benefits in light of significant shift for both patients and providers, in
potential costs are standard recommendations order to set the stage for informed patient-pro-
for implementing value-based care, a qualitative vider value-based decision making in light of
investigation into patient thoughts on discussing risks, benefits, and patient priorities.
cost with healthcare providers as part of making
treatment choices suggests that these conversa-
tions may be more difficult than anticipated. How Do We Measure Quality?
Results from a large focus group study revealed
that insured patients were resistant to the idea of Armed with information and opportunities for
considering costs when deciding among similar open dialogue concerning health decisions, patients
treatment or diagnostic options. Analysis of the can become active participants in their own health
focus group data uncovered four barriers to patients management ensuring that choices made are in line
considering cost when making healthcare deci- with their preferences and priorities and thus
sions: preference for no risk versus minimal risk, obtain value in health care. As previously dis-
assumptions that cost is indicative of quality, a cussed, a key component of high-value health care
belief that choosing a more expensive option is a is patient perspectives of the quality of healthcare
way to get back at insurance companies, and practice and delivery [43]. Value means that the
misperceptions that rising healthcare costs can be medical benefits or outcomes (quality) are com-
reduced through federal budgeting rather than mensurate with economic costs. While qualitative
individual action [41]. methods are important for designing and aiding in
The results of the focus group study are at odds the implementation of value-based care practices,
with numerous reports of the positive outcomes it is not a reasonable approach for assessing, public
associated with shared decision making. One reporting, and comparing quality on a national
potential reason for this discrepancy is that dis- scale. As previously discussed, assessment of patient
cussing hypothetical situations about cost consid- outcomes is vital to the practice of high-value care.
In order to achieve high value, the outcomes of their own health and daily life. PROs include
assessed must represent those prioritized by self-report of symptoms, functional status, and
patients [9], but how do we measure quality? more general perceptions of general health and
well-being. Common PRO domains include
health-related quality of life, functional status,
Patient-Reported Outcomes symptoms and symptom burden, and experience
of care. For an overview of PRO characteristics,
Provision of patient-centered care promotes low see Fig. 7.1 [50]. PROs can be used in a variety of
cost and high-value care [44]. Patient-centered care ways to promote value in health, including, but
is associated with reduced healthcare utilization not limited to, aiding patients and providers in
[45], fewer hospitalizations and readmissions making informed healthcare decisions, monitor-
[46], fewer diagnostic tests and specialty refer- ing outcomes and the progress of care, enhancing
rals [47], and reduced costs. Thus, measurement healthcare service quality, tracking and reporting
and public reporting of PROs is regarded as a performance of healthcare delivery systems, and
necessary means for promoting and enhancing for use when developing policies for health ser-
patient-centered care by advancing accountabil- vice reimbursement and coverage [50].
ity and quality endeavors towards care that is PROs are tools that enable the elicitation, col-
truly centered around its patients [48]. In order to lection, and assessment of PRO information. A
extend assessment of patient outcomes beyond PRO measure, referred to by some as PROM, is
survival, clinical efficacy, and adverse events, we “any standardized or structured questionnaire
must assess PROs to determine the impact of the regarding the status of a patient’s health condi-
disease and treatment upon patient function and tion, health behavior, or experience with health
overall well-being [49]. care that comes directly from the patient” [50].
PROs are representations of how patients feel PRO measures are standardized tools—devel-
and/or their functional abilities within the context oped through qualitative methods to identify top
Fig. 7.1 Characteristics of patient-reported outcomes

patient concerns—that allow comparison of For example, functional status could include
quantitative data across patient groups and/or pro- cognitive function, physical function, and sex-
viders [50]. The use of PRO measures has been ual function [50].
described as critical to enhance understanding of Symptoms and symptom burden are also
how treatments impact patient functioning and important outcome measures for assessing value.
well-being from the perspective of patients them- Symptom assessment should be conducted prior
selves [49]. They show immense promise for to beginning treatment and should be continually
enhancing value in health by strengthening sup- assessed throughout recovery to determine treat-
portive care, improving symptom control, and ment effectiveness. Patient symptoms commonly
enhancing the quality of healthcare delivery [51]. occur in clusters rather than in isolation. Symptom
Moreover, implementation and discussion of burden is a concept that refers to the impact of
actual patient reports during clinic visits can help multiple symptoms on the patient, encompassing
facilitate shared decision making, resulting in both the severity of symptoms and the impact of
improved patient satisfaction with provider com- the symptoms from the patient’s perspective [56].
munication, particularly regarding emotional For example, the PROMIS Pain Interference is a
concerns [51, 52]. highly reliable and valid measure that enables
Health-related quality of life (HRQL) mea- quantification of the impact of pain on function-
sures are multidimensional and commonly encom- ing that can be used across conditions [57].
pass the physical, emotional, and social well-being Likewise, the Functional Assessment of
associated with illness and/or treatment [50]. The Chronic Illness Therapy (FACIT)-Fatigue ques-
Patient Reported Outcomes Measurement Infor tionnaire can be used to accurately measure
mation System (PROMIS®) is a good example of symptoms and symptom burden. The FACIT-F is
an HRQL measurement tool that provides patient- not condition specific, and therefore can be used
reported health status measures for physical, men- for comparisons between a variety of conditions
tal, and social well-being [53]. PROMIS tools are [58, 59]. There are, however, disease-specific
available for use across various conditions and FACIT questionnaires such as FACIT-Dyspnea,
chronic diseases and in the general population. which is a measurement tool that has been spe-
Clinicians can use PROMIS measures to under- cifically tailored to assess dyspnea for chronic
stand how treatments affect patient function and obstructive pulmonary disease [60]. Additional
the symptoms they experience. Such information examples of disease-focused symptom assess-
is useful for enhancing patient-provider communi- ments tools can be obtained from the National
cation, informing treatment plan design, and Comprehensive Cancer Network (NCCN),
improving chronic illness management [53]. Neuro- which catalogues disease-specific symptom
QOL is another HRQL measurement system that indexes for various types of cancer. In collabora-
captures different areas of functioning and well- tion with the NCCN, Cella and colleagues
being in adults and children with neurologic dis- addressed the need for brief and clinically rele-
eases [54]. Neither PROMIS nor Neuro-QOL vant measures by creating a series of 11 disease-
specifies a disease within the item phrasing, mak- specific symptom indexes (bladder, brain, breast,
ing possible a comparison across conditions [54, colorectal, head and neck, hepatobiliary, kidney,
55]. In order to assess the value of healthcare ser- lung, lymphoma, ovarian, prostate) that reflect
vices, patient HRQL must be included in the the highest priority symptoms and concerns of
calculation. patients [61, 62]. While HRQL, functional sta-
Functional status is included in Porter’s tus, and symptom PROs are necessary to assess
three-tier outcome hierarchy. Functional status the quality of health care, the patient experience
measures assess the patient’s ability to perform is another type of PRO that must be included as
basic and advanced activities of daily living. a measure of quality in high-value calculations.
Patient Experience of Care quality of healthcare delivery from the patient’s

perspective. Moreover, enhanced patient experi-
Patient ratings of healthcare experiences are cen- ence is associated with promising outcomes, such
tral to the provision and promotion of patient- as increased adherence, improved clinical out-
centered care, which in turn enhances the value of comes, improved patient safety, enhanced clinical
care. Patient experience involves the perceived effectiveness, and reduced healthcare utilization
needs, care expectations, and actual experience of [48, 72, 73]. In 1995, AHRQ began the Consumer
care received [63–67]. In the past, patient experi- Assessment of Healthcare Providers and Systems
ence and healthcare quality were assessed through (CAHPS) project, a multi-year initiative to pro-
patient satisfaction PROMs. Patient satisfaction mote and support assessment of patients’ health-
is a construct that includes multiple dimensions care experiences through the development of
such as evaluations of patient-provider communi- standardized questionnaires and resources that
cation, level of trust or confidence in physicians, provide both patients and providers with intelligi-
treatment affordability, service availability, qual- ble and comparative information [74].
ity-of-care facilities, and satisfaction with treat- Likewise, in a joint effort, Centers for Medicare
ment explanations and medications [68, 69]. and Medicaid and AHRQ developed the CAHPS
However, in recent years, the construct of patient Hospital Survey (i.e., HCAHPS). HCAHPS is the
satisfaction has been criticized for its lack of clar- first standardized, publicly reported, national sur-
ity in how it is defined and its basis upon subjec- vey of patients’ perspectives of hospital care in the
tive patient experiences, which are largely US. HCAHPS is a 32-item standardized survey of
influenced by patient care preferences and expec- patient perspectives regarding hospital care that
tations [43, 70]. Today, patient-reported experi- enables objective comparisons of hospital perfor-
ence has been distinguished as a more objective mance on topics important to patients. HCAHPS
measure of patient experience and care quality. measures nurse and doctor communication, level
Often, patient satisfaction is conflated with patient of responsiveness to patient needs, pain manage-
experience creating confusion between the two; ment, communication regarding new medications,
yet the two concepts are distinct [43]. provision of critical information at discharge,
Patient experience is a multidimensional con- patient understanding of care needed following
struct that involves patient feedback on what actu- discharge, reports on patient room cleanliness and
ally happened during the course of care including quietness, likelihood to recommend to friends and
observable processes and outcomes, objective family, and an overall hospital rating. HCAHPS
experiences, and subjective experiences [48]. survey results are publicly reported four times per
Patient experience, therefore, involves a range of year on the Hospital Care website, which allows
variables including experiences with scheduling comparisons across national, regional, and local
appointments, wait times, facility cleanliness, hospitals. The website also provides HCAHPS
provision of information, and interactions with all Star Ratings that summarize and legibly report
healthcare staff (e.g., doctors, nurses, assistants, results to make it easier for consumers and patients
receptionists). Thus, patient experience consists to identify and compare hospitals on healthcare
of patient reports of what happened as well as the quality and excellence. HCAHPS is among the
patient’s evaluation or ratings of the experience measures identified in the Patient Protection and
reports [43, 48]. Affordable Care Act of 2010 for use in calculating
Patient-reported experience measures are tools value-based incentive payments in the Hospital
used to evaluate the patient-centeredness and qual- Value-Based Purchasing program [75]. Both the
ity of health care. They obtain patient feedback on CAHPS and HCAHPS are measures that assess
specific care experiences that capture key compo- patient experience on healthcare dimensions for
nents of patient-centered care [48, 71]. Experience which patients are the only or best informational
of care measures yield valuable insights into the source [70].
Measuring Quality in Surgical Care health and healthcare planning. Incorporating

PRO measures into standard care practice will not
To date, no validated measurement system of sur- only help providers assess the impact of treat-
gical care quality exists. In order to align health ments on patients, but it will also give providers
care with efforts to improve quality, Mayer and an opportunity to facilitate shared decision mak-
colleagues (2009) suggested a multidimensional ing and to practice medicine that is centered
approach to assess the quality of surgical care that around the patient. Most of all, the priorities and
incorporates measures of both clinical and PROs preferences of patients must be considered when
over the full cycle of care [76]. Clinical pathway determining the value of screening or treatments,
measures include structured measures (e.g., ratios and PRO measures are valuable tools for achiev-
of doctors to population served, doctors and ing such goals. In sum, high-value care enables
nurses per bed, management capabilities), process the practice of patient-centered care by ensuring
measures (e.g., preoperative, intraoperative, post- that healthcare decision making and choices are
operative facets of care), clinical outcome mea- both responsive and considerate of individual
sures (e.g., procedure-specific outcomes, 30-day patient needs and priorities while simultaneously
mortality, follow-up diagnostics, length of stay, enhancing efficiency and reducing costs.
readmission rates), and economic measures (e.g.,
the amount of cost created per unit of quality-
adjusted output). In addition to measuring clinical References
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Patients and Families
as Coproducers of Safe 8
and Reliable Outcomes
Helen Haskell and Tanya Lord
“We are at our best when we give the doctor who resides within each patient a chance
to go to work.”
—Albert Schweitzer
“The secret of the care of the patient is in caring for the patient.”
—Francis Peabody
an arms-length transaction more than an authen-

Introduction tic partnership.
However much we may struggle with termi-
When describing the optimal relationship nology, most of us know—or think we know—
between doctor and patient, terminology has his- what “it” is supposed to be: a mutually productive
torically been problematic. This is in part due to team of two (or more) working within a system
the fact that the definition of the optimal doctor- that supports their aligned goals in service of the
patient relationship has long been a moving tar- patient’s well-being. The real question is one of
get. The term “patient-centered care,” as used in power dynamics, as the ideal role of the patient
the Institute of Medicine’s Crossing the Quality has evolved from a person gratefully following
Chasm, says little of the role of the patient, who doctor’s orders, to one who is gently encouraged
can thus be interpreted to be the passive recipient to try his or her wings, to an active partner in the
of the doctor’s attentions [1]. “Patient activation,” therapeutic process [3].
in which patients are encouraged to participate in In this slow march toward inclusiveness, the
their own care according to their assessed health next and perhaps most transformative step may
literacy and motivation, conjures up the image of be the theory of co-production. The concept of
a mechanical patient operating on demand [2]. co-production has its roots in the public service
The currently favored term, patient engagement, sector, where it is thought of as a way to make
has a more egalitarian sense, but still can imply public services more efficient and responsive to
the customer, as in, for example, familiar initia-
tives like recycling and neighborhood associa-
tions. Its applicability to healthcare service has
H. Haskell, MA (*) been extensively discussed by Batalden et al. [4],
Mothers Against Medical Error, who point out that it is a deceptively obvious
155 South Bull Street, Columbia, SC 29205, USA term. Co-production puts the emphasis on the
contribution of the beneficiary to the service
T. Lord, PhD, MPH delivery process, and incorporates the concept
Patient and Family Engagement, Foundation for
that greater involvement leads to greater invest-
Healthy Communities, 125 Airport Rd.,
Concord, NH 03301, USA ment on both sides [5, 6]. It includes aspects of
e-mail: [email protected] the parties’ relationship that extend beyond the

102 H. Haskell and T. Lord
immediate interaction, and it has the potential, in ernment services or providing them with stipends
the best of all worlds, to be greater than the sum rather than prepaid services—have become part of
of its parts (Fig. 8.1). Yet co-production is all public policy in many places. Scotland, which has
around us. Like Moliere’s bourgeois gentleman, embarked on a national program of co-production,
who had been speaking prose all his life without uses co-production models in a range of commu-
knowing it, we coproduce whether we intend to nity services, including dementia care, eldercare,
or not. The goal is that we should create the con- and services for children and youth [9].
ditions for coproducing well. Clinical services have been a more difficult
Healthcare support in the community has been nut to crack, both because of their individualized
a ready target for co-production schemes. One of nature and because of long-held attitudes of def-
the best known applications—born, appropriately erence and authority on the part of both patients
enough, in a hospital room—is Edgar Cahn’s con- and clinicians. Yet an increasing number of
cept of Time Dollars, in which individuals “pay” researchers are convinced that the principles of
into a reciprocal web of services using the skills co-production hold the solution to major prob-
they have available. In his account of the genesis lems in our healthcare delivery system, by their
of the Time Dollar theory, Cahn spoke movingly promise of grounding healthcare in the context of
of the power of reciprocity and his sense of need- health, grounding health in the context of com-
ing to “give back” after his feelings of helpless- munity, and informing both with the open
ness as a heart attack patient. Time Dollars are a exchange of ideas [4]. Co-production in health-
successful concept that has been integrated into care services outside the hospital has gained
public services around the world, proving particu- steam with projects such as the UK’s People
larly beneficial in community support of the Powered Health project [10, 11]. Elements of
elderly [7, 8]. Other forms of co-production— co-production undergird the venture philanthropy
involving citizens in planning and design of gov- model of organizations such as the Cystic Fibrosis
Fig. 8.1 Conceptual model

of healthcare service
co-production showing the
interconnectedness of
community, healthcare
system, professionals, and
patients. Reproduced from
BMJ Qual Saf,
Co-production of
healthcare service,
Batalden M, Batalden P,
Margolis P, et al. Epub
2015 Sep 16. © 2015 with
permission from BMJ
Publishing Group Ltd
8 Patients and Families as Coproducers of Safe and Reliable Outcomes 103
Foundation and the community-based model of productive—patient relationships are needed in

the Institute for Healthcare Improvement’s “100 surgery more than anywhere. The theories and
Million Healthier Lives” campaign [12, 13]. methods of co-production do not radically change
Other initiatives, such as Mayo Clinic’s Mini within healthcare. Whether in a surgical situation
mally Disruptive Medicine, use similar principles or other clinical encounter, the concept of includ-
to create a dialogue that takes into account the ing patients and families as equal partners should
toll that medical interventions can exact on apply equally.
patients’ daily lives [14, 15]. Overall, the aim of In Scotland, Bovaird and Loeffler emphasized
co-production in healthcare has been on blurring four aspects of co-production of a public service
the lines between clinic and community and project, as illustrated in Fig. 8.2:
encouraging partnerships that take into account
the lived reality of all sides. Implicit in this is the • Co-commissioning (planning the larger poli-
idea of continuous improvement made possible cies and prioritizing the agenda within which
by feedback and collaboration. the service will take place)
Most thinking around co-production of health- • Codesign (planning the service)
care services has focused on the management of • Co-delivery (managing and performing the
chronic illness. But while it may be true that service)
chronic illness accounts for a sizeable chunk of • Co-assessment (monitoring and evaluation)
healthcare spending, coordination of multiple [5, 17]
chronic conditions is fortunately not yet the expe-
rience of most people [16]. This leaves the prob- While not every one of these aspects is involved
lem of just what co-production should look like in every project, all projects include one or more
for the majority of patients. Envisioning an ideal of them. Taken together, these four parts of the
system is particularly challenging in the episodic whole provide a powerful framework for looking
world of surgery, where relationships may be at co-production in the surgical environment.
fleeting and patients incapable of participating Quality and safety discussions in surgery often
actively during the most significant part of the give short shrift to the complex human context in
interaction. Surgery obviously occupies a central which the surgical process occurs, and the needs,
spot in the house of medicine, however, and a desires, and fears of those involved. Yet the fail-
surgical procedure, even a minor one, is a major ure to give sufficient weight to the human ele-
life event for most patients. Productive—co- ments of culture, judgment, and relationships,
Fig. 8.2 Aspects of co-production. An illustration of four G, Bovaird T, Hine-Hughes F (eds). Co-production of
aspects of co-production as conceptualized by Bovaird T, health and wellbeing in Scotland. Birmingham:
Loeffler E, The role of co-production for better health and Governance International; 2013
wellbeing: Why we need to change. In: Loeffler E, Power
Fig. 8.3 Aspects of co-production in surgery. treatment and co-deliver the healthcare service of surgery
Co-commissioning, the broader social and educational and associated care. Co-assessment allows patient and
framework within which patients and professionals oper- provider to work together to inform and improve the
ate, sets the stage for the personal interaction within other aspects of the surgical process (© 2016 Helen
which patient and professional codesign the patient’s Haskell)
especially as they relate to the patient, is arguably the Internet has been an astonishing leveler in
one reason we have not made more progress in terms of healthcare information. The Pew Internet
improving safety in spite of nearly a generation and American Life Project, which tracked trends
of patient safety efforts. Conscious attention to in Americans’ use of electronic media, reported in
this underlying structure, and use of existing and 2013 that 85 % of all Americans used the Internet,
emerging concepts and programs, can give with many who do not own computers accessing
insights into ways to improve surgical safety by it entirely through their cell phones. Of Internet
facilitating the ability of both patient and doctor users, nearly three-fourths researched health mat-
to engage in effective co-production (Fig. 8.3). ters online. More than half of those used the
Internet to look for an online diagnosis. And in
general, their information was correct: about four
Co-commissioning out of five who took their findings to a physician
had their accuracy confirmed [18].
Co-commissioning in the sense intended here This entree to a wider world of information,
consists of setting the stage for effective collabo- historically unavailable outside medical libraries,
ration through environmental and educational fac- is in itself an upheaval in the doctor-patient
tors that reach beyond the individual doctor-patient dynamic. Of particular interest in this respect is
relationship. Perhaps the most important of these the ePatient movement, begun by health informat-
concepts is access to information. Effective co- ics professor Dr. Tom Ferguson and continued
production means a prepared patient making an after his death in 2006 by a group of his colleagues
informed decision. While not all patients have the calling themselves the e-Patient Scholars Working
resources or the inclination to inform themselves Group. Their 2007 white paper, “e-Patients: How
on medical issues, a remarkable number do so they can help us heal healthcare,” could be consid-
when it concerns their own health. In that respect ered a co-production manifesto [19]. Its premise
was that the disruptive technology of the Internet for eight common surgical procedures [25–29].
had sparked a Kuhnian paradigm change that A similar national surgeon rating system pub-
would lead to greater equality and collaboration lished by Consumers’ Checkbook includes a
between patient and doctor, the synergy of which wider range of procedures and specialties, but
would unleash new potential in medicine. To a restricts its listings to highly rated surgeons [30].
large extent this has come true, as patients, doc- Registries, another potentially invaluable resource
tors, and researchers have begun to work together for patients, now sometimes include not only
to create enhanced technologies, creative data- pooled data but also access to mobile health appli-
bases, and new methods of exchanging informa- cations that allow patients to contribute, receive,
tion. Perhaps most critically, and central to and act upon health information [31]. Registries
Ferguson’s vision, a web of online communities are seldom publicly reported, however. Among a
has sprung up that provides patients with personal handful of notable exceptions are the heart sur-
support, patient-level expertise, and medical ref- gery registries published by Consumer Reports
erences on a myriad of topics, including medical and the Society of Thoracic Surgeons, which
conditions from which people once suffered in include star ratings for adult and pediatric surger-
isolation. One of the more broad based of these ies as well as more detailed underlying numbers
online communities is the ePatient movement on pediatric mortality [32–34].
itself, which lives on as the web-based Society for This data revolution has occurred in the con-
Participatory Medicine, a group that encourages text of an ambitious social and policy agenda set
the use of social media, data sharing, and techno- by government and leaders in the medical com-
logical innovation [20]. munity. Most large public databases in the United
For all its innovation, the ePatient movement States are created from data made available by the
has not concerned itself directly with safety and Centers for Medicare and Medicaid Services
quality. Public transparency on safety measures (CMS) as part of an effort to increase healthcare
is instead derived largely from online databases transparency.2 This effort includes CMS’s own,
and rating services, particularly hospital ratings, usually less detailed, online rating sites: Hospital
created over the past decade by organizations like Compare, Nursing Home Compare, Dialysis
HealthGrades, Consumer Reports, and the Leapfrog Compare, and Physician Compare [41–44]. The
Group.1 Online healthcare measurement has also 2010 Affordable Care Act also specifically
emerged, somewhat unexpectedly, as a journal- includes provisions aimed at enhancing the
istic specialty. Once primarily concerned with patient voice in healthcare. One such initiative is
reporting on accomplishments of local hospitals, the Patient-Centered Outcomes Research Institute
healthcare journalism has transformed itself into a (PCORI), designed to give patients a defining role
rapidly growing investigative field driven by keen in healthcare research, including setting the direc-
interest in big data, patient safety, and perceived tion of research, reviewing proposals, and partici-
conflict of interest [24]. One of the most active pating in grants [45]. The Partnership for Patients,
investigative healthcare journalist groups, the a large patient safety program that included most
nonprofit news organization ProPublica, has cre- American hospitals, made patient engagement a
ated physician-specific public databases including central tenet of its work, with patients an integral
pharmaceutical payments to doctors, Medicare presence in patient safety education, and patient
Part D prescribing patterns, and Medicare Part
B services provided. ProPublica also maintains
This built on earlier reporting by the states. Many state
2
the controversial Surgeons’ Scorecard, which governments still require public reporting of hospital-
analyzes individual surgeons’ complication rates acquired infections, including procedure-related surgical
site infections that are not reported federally [35].
Information on heart surgery outcomes, once much her-
Associated websites are HealthGrades: Find a Doctor
1
alded but now largely superseded by national reporting on
[21]; Consumer Reports: Doctors & Hospitals [22]; and Medicare’s Hospital Compare site, is also still available
Leapfrog’s Hospital Safety Score [23]. on some state websites [36–40].
and family advisory councils becoming part of half were found to reflect inadequate informed
the fabric of hospitals across the country [46]. consent [51].
This was part of a National Quality Strategy with Probably the biggest impediment to open
three aims (better care, healthy people and com- communication is the much-deliberated power
munities, and affordable care) and six priorities, gradient between doctor and patient. Patients are
the top two of which are patient safety and patient often intimidated by a doctor’s medical knowl-
engagement [47]. This is loosely based on the edge, by the doctor’s ability to make decisions
Institute for Healthcare Improvement’s Triple that affect the patient profoundly, and by the alien
Aim, whose three intertwined goals are part of a clinical environment in which the medical
vision of an integrated system emphasizing macro encounter occurs. As a consequence, patients
system integration, value-based financial man- may hesitate to volunteer information, ask ques-
agement, redesigned care models, population tions, or even correct misperceptions, particu-
health management, and close involvement of larly if the doctor seems overly self-assured or
and responsiveness to patients and families [48]. hurried. This can be true even of very experi-
In this age of technological advances informa- enced patients, who may fear antagonizing their
tion may still not be accessible to patients in a healthcare providers if they come across as too
timely manner when surgery is not preplanned or well informed [52, 53]. Alternatively, and coun-
elective. In all cases the sharing and ensuring of ter-intuitively, highly educated professionals may
accurate treatment- or condition-specific infor- be reluctant to ask questions out of what they
mation should still be primarily the responsibility consider the respect due to a fellow professional
of the physician and other hospital staff. [54]. Often, however, the patient and family may
not only have the most complete available knowl-
edge of the patient’s medical history but also the
Codesigning most complete copy of the patient’s medical
record. Most critically, the patient and family
Codesigning—the process through which the alone can transmit information about the patient’s
patient and the surgical team come together for life circumstances and the light they can shed
diagnosis, assessment, and planning of future onto possible diagnoses and the potential effec-
treatment—is the customization of the patient tiveness, ineffectiveness, or even possible harm-
experience within the larger medical and social fulness of specific treatments [55, 56].
framework. This is necessarily about communi- If the problem lies in imbalance of power, then
cation. Analyses of closed claims by the mal- the solution may be to move the fulcrum. In
practice insurer CRICO have demonstrated the the information age, this necessarily begins
critical role of communication in patient care. with improved communication. “ePatient Dave”
While the intricacies of the patient’s role in deBronkart, a kidney cancer patient who has
diagnosis are beyond the purview of this chap- gained notoriety as a blogger and speaker, recently
ter, it is worth repeating that accurate diagnosis wrote about what he considered the nearly ideal
is the foundation of good medicine, and effec- experience of his wife’s knee replacement surgery.
tive communication is the key to diagnostic A major source of satisfaction was his wife’s sur-
accuracy. In an analysis of over 23,000 diagnos- geon’s quick responses to questions sent through
tic errors, CRICO found that 58 % occurred dur- secure e-mail. DeBronkart quoted the surgeon as
ing the assessment phase [49]. In surgical cases saying, “Most people are too afraid to ask ques-
specifically, CRICO found communication tions … so I offer platforms to communicate
breakdown to be a factor in one-fourth of mal- which are less imposing than sitting on a cold
practice payouts between 2009 and 2013, with bench in my office with the clock ticking” [57].
nearly two-thirds of these featuring breakdowns Such strategies are part of what is rapidly turn-
between provider and patient [50]. In another ing into a deluge of communication technologies,
report focused on surgical closed claims, over as patients wake up to the possibilities presented
by greater access to their medical information. providing detailed information on options and
Among these is the highly publicized Open Notes supporting the patient in the decision process—
project, which allows patients to look at doctors’ has gained wide currency in recent years. At the
notes from their office visits, and has received a heart of shared decision making is the clear expla-
thumbs-up from a resounding 99 % of early users nation of harms and benefits using such concepts
[58, 59]. Patient portals, after a rocky start, are as absolute (rather than relative) risk and commu-
becoming an indispensable patient resource as nication strategies like “chunk and check” and
they expand to include such conveniences as teachback [65]. Decision-making tools, an impor-
online prescription refills and scheduling of office tant part of the process, are now available in a
visits, in addition to e-mail communication with variety of media for many common conditions, as
doctors and online test results [60]. Patients are are general decision aids like the Ottawa Personal
also increasingly interested in electronic access to Decision Guide [66, 67]. But while useful, deci-
their entire medical record: nearly 90 % of sur- sion aids can be a relatively facile approach to a
veyed Open Notes patients indicated a desire for topic fraught with complexity. While patients
real-time access to inpatient records, while an may find it easier to absorb information from an
online survey by the research and management electronic or video-based decision tool, most peo-
company Accenture reported that 41 % of (pre- ple also want to have an in-depth discussion with
sumably highly engaged) respondents said that their physician that covers the evidence, patient
they would switch providers to have access to preferences, and patient’s circumstances [64]. If
their complete records [59, 61]. Patients’ and doc- evidence-based options are genuinely equivalent,
tors’ views of the value and challenges of shared patients may benefit from more guidance than
medical records differ substantially, however; many currently receive in balancing available
while doctors worry that attempts to avoid offend- options with their own life situations. On the
ing patients may result in less than candid medical other side of the equation, guidelines that seem
assessments, patients are more concerned about unambiguous on their face may gloss over
being able to correct errors and misperceptions patients’ personal preferences and concerns as in,
and using their knowledge to help bridge commu- for example, the risk of bleeding from warfarin.
nication gaps. More broadly, patients use access Drawbacks of any intervention may loom much
to their notes to refresh their memories, to keep a larger for individual patients than guideline writ-
personal record, and to share their medical infor- ers could foresee, and may also warrant physician
mation with relatives [62]. assistance in exploring the nuances of the deci-
The most difficult topic in presurgical com- sion [68]. Perhaps the key to finding the right bal-
munication remains the perennial issue of ance of information given during a consent for
informed consent. The patient’s right to and surgery discussion lies in the very nature of
interest in informed consent have evolved over co-designing the partnership between the patient
decades as court decisions and changes in public and the physician. Even in a very brief encounter
attitude have gradually eroded the “therapeutic it is possible to assess a patient’s needs and desires
privilege” to withhold information [63]. Informed as they pertain to informed consent.
consent matters to patients: in surveys the vast Other gaps relate to the patient’s experience of
majority of people, even those with limited health surgery. Patients often have an unrealistic image
literacy or poor English-language proficiency, of the benefits of surgery and may have little
say that they want to take an active role in health- understanding of the realities of postsurgical
care decisions. This is true even of patients who recovery or the possibility of a less than optimal
say that they prefer that their physicians make the outcome [69]. In a survey of incoming patients at
final decision [64]. a major teaching hospital, nearly half of patients
The question that continues to swirl around the who were scheduled to go to the intensive care
issue of informed consent is exactly what it unit postsurgically were unaware of that fact,
should consist of. Shared decision making—i.e., while a substantial minority were ambivalent
about undergoing surgery at all. Half did not have only 1 % thought that residents should be allowed
advance directives [70]. A study of Medicare to be on duty over 24 h [75]. In both surveys, more
patients between 2002 and 2006 found that 96 % than 80 % of respondents said that patients should
of patients diagnosed with stage IV cancer under- be informed of residents’ level of supervision or
went invasive procedures, with one in four hav- sleep deprivation and that this information could
ing a procedure in the last month of life [71]. change their decision to consent to surgery [76].
Lilley et al. [72] attribute this to a “fix-it” model This unambiguity of opinion makes it clear that
of surgical success that focuses on the disease at failing to acknowledge the full circumstances of a
the expense of the patient. Diffusion of responsi- patient’s surgery deprives patients of information
bility may also play a role, as patients move they want and need, but may not know that they do
among different specialists who may defer to not have. If patients and providers are to work in
each other until the patient is at a point of crisis. productive partnership, clear explanation of the
Surgeons, to whom almost all these patients contribution made by all partners is an essential
come at some point, may be in a unique position part of the conversation.
to engage the patient and family in critical dis-
cussions around patient goals and quality of life.
Other difficult issues that are of intense interest Co-delivery
to patients are cost (a source of great anxiety in the
USA in the era of narrow insurance networks, In 2012, Leonard Kish described the astonish-
whose enrollees may be left with ruinous bills ingly improved outcomes of patient-centered
from out-of-network providers they did not know medical programs and declared patient engage-
were involved in their care) and infection and ment to be “the blockbuster drug of the century”
complication rates, which have some online avail- [77]. Current patient-centered surgical programs,
ability at state websites and CMS’s Hospital ranging from various degrees of prehabilitation to
Compare, but are generally not specific enough to complete programs like Enhanced Recovery after
be of help to most patients. Genuinely relevant Surgery and the Perioperative Surgical Home,
information is often available only from the health- employ a combination of standardization, per-
care provider. As the pace of healthcare picks up, sonalization, and close attention to patient status
patients are also increasingly concerned about with the intent of controlling variation in care and
working conditions in surgical suites, not least the holding down costs. Common aspects are preop-
issues of resident supervision and fatigue. In spite erative patient screening, education, and condi-
of the Accreditation Council on Graduate Medical tioning; use of standard protocols and guidelines;
Education requirement that residents and faculty personalized care planning; minimal use of opi-
inform patients of their respective roles, the extent oids; early mobilization; and standardized post-
of resident participation in surgery remains pro- discharge communication and care [78–82]. These
foundly unclear to patients [73]. In a 2012 survey programs have largely been developed using
conducted at a tertiary care center, 94 % of respon- standard improvement techniques to combine
dents initially agreed to consent to trainee involve- advances from many different fields, with close
ment in their surgery, a percentage that fell to 18 involvement of the patient and family a key com-
when they learned that residents could operate ponent from planning through post-discharge
without direct supervision [74]. Public opinion on [80, 83]. Comprehensive surgical pathways have
fatigue is also strikingly at odds with that of the had a transformative effect on more easily stan-
medical profession. In a 2010 telephone survey of dardized procedures like joint replacements and
the general public, respondents dramatically some gastrointestinal surgeries. The aim of mini-
underestimated the number of hours that resident mizing disruption of the patient’s normal physiol-
physicians work, with most believing that resi- ogy has mitigated formerly dreaded aspects of
dents’ shifts were 12 h or less. Over 80 % believed surgery like prolonged fasting and opioid-induced
that fatigue correlates with medical errors, and grogginess and nausea, with accompanying
increase in patient satisfaction. At the same time, information, encouragement, and support. This
the combination of individualization of care with includes information about signs and symptoms
standardization of processes has led to reductions that can be expected in a postsurgical patient,
in adverse events, infection rates, lengths of stay, those that are cause for concern, and an explana-
and readmissions, a testament to the interrela- tion of monitors to which the patient may be
tionship of patient engagement and patient safety attached. For hospital inpatients, a constellation
[84, 85]. of well-studied policies including bedside change
Comprehensive surgical programs are founded of shift, scheduled bedside rounding, daily care
on the idea that surgery is a team endeavor includ- plan summaries, and instruction in fall prevention
ing the patient and family and extending beyond can be used to facilitate family involvement. The
the operating room. One obvious barrier to effec- whiteboard is also an invaluable tool for relaying
tive teamwork is disequilibrium of knowledge. In names, contact details, questions, and updates.
the case of patients and families, this applies not Encouragement of journaling by patient and fam-
just to the details of the patient’s medical condi- ily, both in hospital and at home, allows for coor-
tion but to the system within which healthcare is dinated tracking of the patient’s progress by
provided. This topic, a source of intimidation for family and surgical team [80, 93–97].
most patients, is seldom addressed in information The most important transition that a patient
given to patients. For many nonmedical people, makes is from hospital or surgical facility to home
one of the most confusing aspects of medical care or rehabilitation center. While discharge planning
is the sheer multiplicity of members of the health- is an advanced science in some arenas, pitfalls
care team. Although patients may rapidly pick up remain in even the best planned discharges. A
terms like “resident” and “tech,” they often do not successful discharge process involves the patient
really understand the roles or even the identities of and family closely and for elective patients may
the people they meet. Experience suggests that begin as early as the decision for surgery [98]. It
this confusion may be hard to overcome, but iden- is important to have an understanding of the con-
tification of caregivers is a common patient ditions into which the patient will be discharged,
request. Written or visual explanations of the peo- to verify that patients and families have a realistic
ple involved in their care and when they should be understanding of the process of recovery and
called upon can help reduce patients’ sense of expected outcome, and to be sure that they have
helplessness in the unaccustomed world of the information they need to manage home care. Like
hospital or surgery center [86–89]. Simple com- all patient information, discharge instructions
munication strategies for all team members should be in everyday language. Standardized
(“Smile,” “Sit down,” “Introduce yourself”) also processes like AHRQ’s IDEAL Discharge and
go far toward creating good patient relations [90]. Project RED provide checklists for important dis-
The importance of family and other designated charge components, including medication recon-
support people as part of the patient’s care team ciliation, follow-up appointments, and signs and
can hardly be overestimated. Family members symptoms for families to watch for [99, 100].
can and should be deliberately looped in through- Surgical patients, even same-day surgery patients,
out the surgical process, including by telephone if can feel isolated and unprepared after being dis-
necessary in the planning and post- discharge charged to home and often are alarmed by diffi-
periods. On the day of surgery, families are typi- culties in reaching their surgical team. Having a
cally grateful for regular updates delivered via 24-h telephone number they can call with any
electronic tracking boards, nurse liaisons, or concerns and receiving a call from a representa-
mobile device applications that can transmit video, tive of the surgical team soon after discharge do
photographs, or messages from the operating much to alleviate those fears and deal with prob-
room [80, 91, 92]. Especially postoperatively, lems as they arise [101]. Scheduled calls with
families are de facto coproducers who can fulfill specific questions routinely after patient discharge
their roles most effectively if they are armed with inquiring about the patient’s progress may reveal
unexpected minor complications (e.g., lacera- who reported that surveyed spine patients
tions, teeth damage, hair loss, etc), opportunities recorded 40 % more complications than their sur-
for education or intervention to ward off compli- geons did, and that patients and physicians often
cations, as can telephone availability of and on- reported entirely different complications.
call surgeon [80, 102]. A wound care app to allow Franneby et al. [113] found that hernia repair
patients to communicate easily with, and send patients recorded a complication rate 4.5 times
photos to, their surgical team has been enthusias- higher than their surgeons. Basch [114] reported
tically received by early users [103, 104]. that cancer patients recorded more severe symp-
It has long been recognized that patients may toms, earlier and more frequently than their doc-
develop deleterious conditions as a result of hos- tors, and that patients’ reports had a closer
pitalization [105, 106]. In 2013, Harlan Krumholz correlation to their functional status than the doc-
noted that a majority of hospital readmissions tors’ did. This difference of perception has sig-
were for causes other than that of the original hos- nificant implications not only for informed
pitalization. He blamed depersonalization, poor consent but also for treatment decisions and the
nutrition, lack of sleep, excessive blood draws, overall value of interventions to patients [115].
and other disruptions for causing physiologic In addition, patients and providers may have dif-
derangement and depletion of reserves in vulner- ferent measures of surgical success. The goal of
able hospital patients, and called this condition most patients is their own global well-being, a
“posthospital syndrome” [107, 108]. Krumholz fundamentally different concept of success from
suggested that patients be assessed for cognitive many current measures that emphasize process
and physical impairments potentially arising from over outcome and clinical over functional status
their hospitalization and that post-discharge sup- [116]. Patient-reported outcome measures are
port be adjusted accordingly. He also suggested beginning to proliferate, however, and in research,
that, like discharge planning, planning to prevent especially pharmaceutical research, patients have
unneeded readmissions should be pushed back become sought-after partners, as funders and
into the hospital stay, by seeking to minimize researchers have come to recognize that the voice
stressors like sleep disruption, unneeded pain, and of the end user has significant value [117–120]. A
inappropriate use of sedatives [109]. Other mea- similar claim can be made for patient safety and
sures that Krumholz recommends to help prevent quality, where patients also often have very dif-
patient disorientation are reminiscent of those ferent perspectives from healthcare profession-
practiced at hospitals following the Planetree als, a fact that has long been underappreciated
model of patient-centered care. These include [121, 122]. In the face of the new push toward
allowing patients to wear their own clothes, pro- transparency, that wall is beginning to crumble.
viding a cheerful noninstitutional decor, and tailor- One factor that has revolutionized thinking
ing the diet to include healthy appealing foods to around the patient role in the USA is the linking of
which the patient is accustomed [107, 108, 110]. Medicare reimbursement with the Hospital
Consumer Assessment of Healthcare Providers
and Systems patient experience survey (HCAHPS),
Co-assessment now publicly reported by hospital on Medicare’s
HospitalCompare website [123]. Hospitals now
It is a truism that is not often given enough import expend significant resources on improving the
in medicine: the only person who knows the patient experience. While healthcare professionals
actual outcome of the patient’s treatment is the do not always view HCAHPS as quality improve-
patient. The obvious corollary is that any serious ment per se, patient satisfaction has been docu-
review of outcomes must give prominence to the mented to have a positive effect on patient
patient’s experience [111]. There seems to be lit- outcomes, and some if not most HCAHPS ques-
tle question that patients report more, and more tions (e.g., How often did you get help as soon as
severe, symptoms and complications than doc- you wanted it? How often were your room and
tors do. Examples include Mannion et al. [112], bathroom kept clean?) are directly or indirectly
aimed at patients’ perception of safety and quality around. You feel like you’re a bit of meat on a
of care [124–126]. Nevertheless, there is concern conveyor belt.” These sentiments, not surpris-
that patient satisfaction is being used as a proxy ingly, did not emerge on the formal survey [131].
for quality of care and that, in spite of years of The authors proposed that, where interviews are
refinement, surveys may not be the most direct not an option, open comments (similar to the struc-
way to elicit problems with safety and quality. ture of YELP reviews) should be encouraged and
Two recent studies have found good correlation scrutinized on surveys. In open-ended patient com-
between HCAHPS scores and patient reviews of mentary, it is clear that patients and families not
hospitals on the online rating site YELP, best only report aspects of their care not otherwise cap-
known for restaurant and hotel ratings [127, 128]. tured but also place a priority on interpersonal rela-
There are advantages to YELP: YELP reviews are tions and being treated with dignity and respect,
generally easier to find than the HospitalCompare factors not always covered in standard healthcare
website where HCAHPS scores are housed surveys (although they are in HCAHPS) [132].4
(only 6 % of survey respondents had heard of These studies suggest, at a minimum, that there is
HospitalCompare) and they were also found to much to be gained from an expanded role for
address domains of quality that HCAHPS did not, patients in assessment of quality of care and health-
including nuanced aspects of nursing quality and care delivery, but also that patient input could help
staff attitudes. Further blurring the line, YELP reshape the definition of quality and safety.
has since entered into a partnership with the Though not yet supported by research, an
healthcare journalism organization ProPublica, effective method of working with HCAHPS
which has aided them in adding statistics from results is to bring them to the hospital’s patient
HospitalCompare to their hospital listings [129].3 and family advisory council for review. Council
Along the same lines, Tsianakis and col- members are often able to provide insight and the
leagues found that British breast cancer patients additional information necessary to promote
gave differing accounts of their care depending changes.
on whether they were providing the information The issue of data collection methodology has
via survey or interview. This appeared to be at in some ways been overtaken by technology, as
least partly because the surveys did not anticipate hospitals have begun arming nurses with elec-
and therefore did not explicitly cover areas that tronic tablets to use in rounding on patients.
turned out to be of importance to patients. Among Failure to rescue, a significant driver of hospital
the problems that surfaced more often in patient mortality, is associated with miscommunication
narratives than in surveys were concerns about by bedside caregivers and often with failure to
outpatient surgery, including feeling rushed, heed families’ concerns [134–137]. In the UK,
being separated from family too soon, and not nurses collect vital signs on tablets with applica-
having procedures explained beforehand. One tions that track trends and alert them to potential
interviewee was quoted as saying, “A lot of the patient deterioration, an innovation considered to
things are quite brutal and you’re not told they’re have averted many cases of failure to rescue
going to happen. It’s just like, ‘Now we’re going [138]. In the USA, nurse rounding with tablets is
to do this to you,’ and you do begin to feel humili- becoming commonplace for a variety of quality
ated because you’re constantly naked and having improvement and data collection purposes,
horrible things done, injections and poked including routinely inquiring about and resolving
patient concerns and collecting data to compare
trends in quality concerns and patient satisfaction
Although there has also been considerable interest in
3
mining social media for patient opinion, a recent feasibil-

[94, 139, 140]. While the ultimate aim may be to
ity study of Twitter comments had somewhat less robust
results, possibly an indication of the limitations of the
medium. About 1000 English-language patient tweets Even in written complaints to medical boards, patients
4
were identified over a 9-month period, of which 14 % often focus on the issue of doctors’ rude behavior, even
explicitly concerned surgical errors and approximately when it has occurred in the context of severe medical
half expressed an emotional reaction [130]. errors [133].
improve patient satisfaction scores, these prac- profound betrayal of trust; for many people it is
tices embed the patient voice, make patient feed- more traumatic than the medical injury itself
back part of the nurses’ daily operations, and [147]. Providers, too, suffer from this approach,
create the potential to deal with emergencies as which not only shatters the doctor-patient rela-
they occur. Other real-time solutions include tak- tionship but also assails the physician’s essential
ing advantage of existing resources, not necessar- role as benevolent professional. “Communication
ily technological, to prevent adverse events: and resolution” programs now in place at many
critical care outreach nurses who round proac- major medical facilities have shown that the
tively on high-risk patients; patient-activated financial costs of a lawyer-driven system gener-
rapid response systems, a vital “911” safety valve ally exceed those incurred with more humane and
for family members of deteriorating patients; and proactive treatment of both patients and caregivers.
mining rapid response reports, especially patient- The major advantage of communication and
initiated calls, to look for patterns that could shed resolution programs, however, is the ability to cre-
light on patient concerns that might flag potential ate conditions under which relationships can heal
patient safety problems [141–143]. and participants can learn from errors [148–151].
An even more direct way to get the patient per- Research also indicates that patients and fami-
spective is the technique of shadowing, especially lies, by dint of their often-uninterrupted presence
as refined by the University of Pittsburgh’s Patient at the bedside, can provide insights into safety
and Family Centered Care Innovation Center. In events and hazards that otherwise go undetected
this effective, low-tech methodology, shadowers [122, 152, 153]. One clear implication is that
accompany patients through their experience of event reviews or root-cause analyses are likely to
care to look for gaps and deficiencies in the probe incomplete without the patient perspective,
cess. A multidisciplinary workgroup, including whether in the form of interviews with the affected
patients, then “writes the ideal experience” of families or through participation by affected fam-
care and designs solutions [144]. Shadowing can ilies or other patient representatives on the root-
find system flaws that interviewing and surveys cause analysis committee itself. This kind of
do not, and may reveal “touchpoints” of interac- participation is increasingly occurring as hospi-
tion with the system of which caregivers were tals and even practices recognize the importance
unaware. The discovery that total joint patients of the patient point of view. For some families,
often had parking issues, for example, was a the knowledge that learning and improvements
touchpoint leading to the idea of valet parking at have come from their devastating medical experi-
orthopedic centers. One executive commented ence offers comfort and a basis to build trust
after using shadowing for quality improvement, [154–156]. As healthcare moves toward a more
“I am no longer a fan of surveys. Everyone always inclusive and transparent way of engaging and
told us how nice we were, and gave us high caring for families following adverse outcomes it
scores. Shadowing, however, showed us our real is important to recognize the continued need to
opportunities to improve the patient experience” personalize care. Patients and their families come
[145, 146]. Using former patients or other non- into healthcare with varying experiences, thoughts,
hospital employees as shadowers can add another values, fears, and desires. When this individual-
layer of insight that might otherwise be missed. ism is recognized as an asset and seen as the
Probably the most critical moment in patient- key to safer care, then true co-production can be
provider relations is the moment when a patient achieved.
has been seriously harmed by his or her medical
care. Traditionally, many institutions have advised
physicians to withdraw from communication with The Bigger Picture
such families, on the assumption that any situa-
tion involving potential compensation is necessar- These initiatives are all part of a larger trend. If
ily adversarial. For families, the descent of this healthcare facilities are truly to operate in the
curtain of silence is almost invariably seen as a interests of patients, then the voices of patients
need to be heard not just as patients but as col- treatment, and open access to information that is a
laborators, partners, and educators. To a signifi- recurring theme of patient response to the health-
cant extent, this is happening. Patient and family care system. As patients are well aware, disre-
advisory councils, a classic example of co- spect has the power to harm, and depersonalization
commissioning, are now embedded in the culture and lack of transparency can be among the most
of many hospitals [46]. As health systems con- damaging forms of disrespect. Reciprocity, as
solidate, the concept of patient and family advi- Edgar Cahn articulated, is also a fundamental
sory councils is spreading to ambulatory care source of respect and self- respect, and a key
[157, 158]. Nationally, the belief is gaining cur- driver in patients’ desire to be part of the system.
rency that a primary concern of patient advisory Although the disruptive potential of health infor-
bodies should be safety and quality, as is the idea mation technology has opened new avenues for
that the system as a whole can benefit from hav- communication and information sharing, the
ing patients on committees throughout the insti- blueprint for effective co-production, like much
tution. Patients are increasingly serving on in medicine, is not entirely new. What is different
quality committees and governing boards, on now, perhaps, is the accumulating will to act on it.
improvement projects, and as instructors in Every patient who receives and every provider
capacities ranging from employee orientation to who offers healthcare services come with a unique
medical school lecturers. They are involved in set of skills, desires, strengths, and weaknesses
federal research grants and serve on committees that impact their approach to co-production.
that decide policy, endorse quality measures, Improving healthcare cannot be accomplished
approve medications, and more [45, 159–161]. solely by error-proofing processes or by creating
Although a minimum standard has yet to be set for a series of standard work. Safer healthcare and
institutions, the goals of patient engagement are safer surgeries need to rely on the fundamental
clearly based on the principles of co-production. thing that humans are designed to do: build con-
Recent definitions stress the interactive and com- nections and relationships with each other. All
prehensive nature of patient engagement, while improvement methods are made more effective
various frameworks, including an eight- part when patient and families are included in their
Patient Engagement Roadmap, describe strategies development, implementation, and evaluation,
and tactics for creating partnership from the indi- both at the bedside and within the organization
vidual patient encounter up through national pol- [168]. Whatever terminology comes in and out
icy [162–164]. of favor, the concept of partnering, knowing
These ideas are not unprecedented. In fact, patients as individuals, and working together for
they really are the foundation of much of modern healthier lives and communities should never go
medicine before the influx of technology. In the out of style.
past, country physicians knew the patients they
were treating. They often visited them in their
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Tools and Strategies
for Continuous Quality 9
Improvement and Patient Safety
Julie K. Johnson and Paul Barach
“Everyone has two jobs: to do their work and to improve their work.”
—Paul Batalden, M.D.
• The ideas come from the workers themselves;

A History of Quality Improvement thus they are less likely to be radically differ-
ent and, and therefore, easier to implement
Continuous quality improvement (CQI) is both a and less prone to induce resistance.
management philosophy and a management • Small improvements are less likely to require
method. It offers an approach, a set of tools, and a major capital investment than major process
way of thinking about how to transform clinical changes.
flow and operations to achieve better results for • Employees will continually seek ways to
patients and teams [1]. The evolution of CQI in improve themselves by improving their own
health care may be traced to the pioneering work performance while encouraging workers to
of Florence Nightingale in 1850s. Nightingale take ownership for their work, thereby improv-
used empiric observations and robust statistical ing worker motivation and engagement.
methods to link unsanitary conditions with the
high number of preventable deaths during the From Kaizen came “quality function deploy-
Crimean War [2]. In the 1960s, an approach known ment,” which combined quality assurance and
as Kaizen (literally “change good” or “improve- quality control with function deployment in value
ment”) was introduced in Japan [3]. Grounded engineering [4]. Quality function deployment
in local village knowledge and practices, the key (QFD) helped to focus improvement efforts on
features of Kaizen include the following: the customer’s needs by attending to and respect-
ing the voice of the customer (VOC) and by
translating these needs into design and engineer-
J.K. Johnson, MSPH, PhD (*)
Department of Surgery, Center for Healthcare Studies, ing characteristics for a product or service [5].
Institute for Public Health and Medicine, Feinberg QFD is a process of developing customer needs
School of Medicine, Northwestern University, into actionable responses.
633 North St Clair, Chicago, IL 60611, USA The same concepts and activities are now
often referred to as “quality improvement” or
P. Barach, BSc, MD, MPH, Maj (ret.) “quality management” or even sometimes simply
Clinical Professor, Children’s Cardiomyopathy
Foundation and Kyle John Rymiszewski Research as “improvement” [6]. These concepts have now
Scholar, Children’s Hospital of Michigan, spread throughout the world and across multiple
Wayne State University School of Medicine, economic sectors, including health care. What
5057 Woodward Avenue, Suite 13001, Detroit, was originally called total quality management
MI 48202, USA
e-mail: [email protected] (TQM) in the manufacturing industry evolved

122 J.K. Johnson and P. Barach
into continuous quality improvement (CQI) as it CQI is distinguished in health care by the rec-
was applied to healthcare administrative and ognition that service excellence and high-value
clinical processes. outcomes are predicated on meeting the patients’
Cross-disciplinary learning between manufac- needs. Meeting these needs is the key to sustain-
turing and health care was spurred during the ing quality. However, these needs may change
1990s by the increasing awareness that health over time with changes in expectations associ-
care was lagging behind other industries in pro- ated with education, economics, technology, and
viding poor and uneven value [7]. This high- culture. Such changes, in turn, require continuous
lighted the need to focus on reducing waste, improvements in the administrative and clinical
inefficiencies, and harms. This awareness of the methods that affect the quality of patient care.
limitations of traditional methods to improve
patient outcomes and contain costs forced health
care to look to other domains for solutions [8]. pproaches to Quality
A
However, from the perspective of healthcare pro- Improvement
viders, the industrial perspective of quality is lim-
ited in that it (1) ignores the complexities and Several successful, multilevel, broad-based
dynamic nature and nuances of the patient–practi- approaches have evolved across a range of clini-
tioner relationship; (2) downplays the knowledge, cal disciplines. These approaches can be thought
skills, and intrinsic motivation, as well as the ethi- of as an umbrella that encompasses specific
cal obligations of practitioners; and (3) provides change methods. The most notable of these
less emphasis on influencing professional perfor- approaches are the plan-do-study-act (PDSA)
mance through “education, retraining, supervi- cycle, the model for improvement, lean manufac-
sion, encouragement, and censure” [1]. turing, and Six Sigma—each will be described
Avedis Donabedian conceptualized quality as below. Another common approach to quality
a chain linking structure, process, and outcomes improvement—the quality improvement collab-
and [9] suggested that the fundamental sound- orative—is described in Chap. 45.
ness of healthcare quality traditions can be appre- Walter Shewhart, at Bell Laboratories, intro-
ciated and, at the same time, the industrial model duced the iterative approach called plan-do-
of quality calls attention to several important
considerations [8]:
1. The need for even greater attention to con-

sumer requirements, values, and expectations
2. The need for greater attention to the design of
systems and processes as a means of quality
assurance
3. The need to extend the self-monitoring, self-
governing tradition of physicians to others in
the organization
4. The need for a greater role by management in
assuring the quality of clinical care
5. The need to develop appropriate applications
of statistical control methods to healthcare
monitoring
6. The need for greater education and training in
quality monitoring and assurance for all
concerned Fig. 9.1 The plan-do-study-act cycle
9 Tools and Strategies for Continuous Quality Improvement and Patient Safety 123
Fig. 9.2 The model for

improvement, which
incorporates the plan-do-
study-act cycle
study-act (PDSA; Fig. 9.1) [10] (although the that involves elements of defining what a busi-
PDSA cycle is often attributed to Deming, he ness does, assigning responsibilities, identify-
himself referred to it as the Shewhart cycle) [11]. ing performance standards, and deciding how
The model for improvement (Fig. 9.2), which success will be determined (see below). After
was introduced in 1992, integrates the PDSA these critical elements have been defined, Six
cycle as its core method [6]. Central to its appli- Sigma analyzes each through the DMAIC meth-
cation are three key and recurring questions: odology (improve, and control) [13, 14].
“Lean,” also known as “lean manufacturing,”
1 . What are we trying to accomplish? “lean enterprise,” or “lean production,” is a CQI
2. How will we know that a change is an
approach that considers as wasteful any resources
improvement? that are allocated to any goal other than creating
3. What change can we make that will result in value for the customer and that are thus targets
an improvement? for elimination [15]. Value is defined from the
customer’s perspective and includes any action
The wide use of the PDSA cycle and the model or process for which a customer would be will-
for improvement in health care is the direct result ing to pay.
of their elegance and simplicity, as well as the For many, lean is an approach to improvement
transferability and application of these approaches that helps to identify and steadily eliminate waste
across multiple care and nonhealth settings. in processes (or muda, in Japanese). As waste is
In the 1980s the Motorola Corporation devel- eliminated, quality improves and production time
oped the Six Sigma methodology [12]. Six and costs are reduced. Essentially, lean is centered
Sigma starts with a process-mapping activity on preserving value with less work. Lean should
optimize the trade-off between productivity and Safety Checklist. In a little more than 2 years, more
quality and highlights the axiom that improved than 3900 hospitals in more than 122 countries
quality translates to improved profitability, or were registered in the initiative. Of these 3900 hos-
good quality is good business. pitals, more than 1800 have reported using a check-
list in at least one operating room [21, 22].
The Dutch SURPASS study, conducted from
Quality Improvement Tools October 2007 to March 2009, found that hospi-
tals using checklists had surgical complication
Several CQI tools can help understand and rates that were more than one-third lower, and
improve surgical care [16]. The most relevant death rates that were almost one-half lower (from
tools for surgical settings are checklists, process 1.5 to 0.8 %), than they were in hospitals not
flow maps, Ishikawa diagrams (cause-and-effect using checklists [23].
diagram), run charts, and control charts. Researchers at Stanford found that the observed-
to-expected mortality ratio declined from 0.88 in
quarter one to 0.80 in quarter two, with the use of a
Checklists modified version of the WHO Surgical Safety
Checklist [21, 22]. The use of checklists also
Among the basic tools of quality, the checklist has improved communication among the surgical team,
received the most attention (and press) for improv- and thus the quality of care. Quality was measured
ing patient safety. Evidence supports greater adop- by the frequency with which staff reported “Patient
tion of checklists in surgery [17] and in other Safety Never Events” (i.e., the kind of events that
medical specialties [18–20]. In June 2008, the Safe should “never happen”). The number of Patient
Surgery Saves Lives Initiative of the World Health Safety Never Events related to errors or complica-
Organization (WHO) released the WHO Surgical tions decreased from 35.2 to 24.3 %.
Fig. 9.3 A surgical safety checklist template modified from the World Health Organization
The website Safesurg.org provides resources cisely what an individual provider is required to
for implementing the WHO checklist or for do and when, in terms of cognitive processes,
modifying an existing checklist. Modified check- actions, or both, to achieve the system’s goal.
lists created by other institutions can also be Data are collected from observations or inter-
downloaded (Fig. 9.3) [24]. Modifying check- views that carefully break down complex clinical
lists to fit local practices and needs is encour- processes into discrete, measurable, and clear
aged to enhance acceptance. tasks [32]. Team members can gain insights into
Although checklists have been widely adopted, how they and their colleagues perceive the same
their effectiveness has been highly variable if they tasks and hopefully come to a shared understand-
are casually applied only as tick-box forms and in ing of the process.
a top-down approach [25]. Ineffective top-down Ultimately, improving patient outcomes
engagement and inauthentic partnering and requires appreciating the inherent links between
engagement with clinicians inhibit positive process and results. Process maps help focus
behavior change and encourage normalized devi- improvement efforts, not for the individual, but
ance [26]. Introducing a checklist in an environ- for the entire clinical microsystem [33].
ment characterized by a lack of trust causes Visualizing the process can also help identify
clinicians to feel jeopardized professionally and inefficiencies (e.g., parallel or redundant pro-
personally, and encourages gaming of clinical cesses that have emerged for whatever reason),
metrics and measurements [27]. Effective adop- clarify roles, and reduce ambiguity among team
tion requires local championship, sustained clini- members, all of which can help coordinate patient
cian engagement, and a commitment to teamwork care. This process is particularly useful in improv-
[28, 29]. ing surgical patient transitions of care and avoid-
ing readmissions and bounce back to the intensive
care and high-dependency units [34, 35].
Process Maps Process maps show how interactions occur,
uncover variations, and make the invisible process
A process map or flowchart is a visual represen- visible. Process maps can be created at different
tation of the care process that is created with levels of detail to illustrate the major phases or
information provided by team members. The pro- detailed activities in that process. It is important to
cess mapping exercise can help clinicians clarify map the current process, not the desired process,
through visualization what they know about their to identify opportunities for improvement. We
environment and determine what they want to have used process mapping in multiple settings to
improve about it [30]. The process maps use better understand the processes of care, including
common flowchart symbols and can describe the pediatric cardiac surgery (Figs. 9.4, 9.5, and 9.6),
current state or baseline, the improved state in and to summarize the data on near misses and
transition, and the optimal state [31]. The exer- adverse events (Fig. 9.7) [32, 37].
cise helps clinicians make assumptions and
expectations explicit and can provide insights
into reflecting on their current state and, impor- Ishikawa Diagrams
tantly, into how to improve the process of care or
to overcome barriers they perceive to its improve- Ishikawa diagrams, also known as “cause-and-
ment [32]. Working with clinicians to understand effect diagrams,” “fishbone diagrams,” and
their clinical sensemaking is essential if they are “root-cause analyses,” are visual representations
to become and sustain their interest and engage- of the sources of variation in a process [38]. The
ment in long-term continuous improvement [27]. diagram is often created by brainstorming with
A high degree of process awareness often key stakeholders to identify the causes of the
drives the design changes needed to sustain effects of a process. The causes are generally
improvement. Process mapping describes pre- allocated to five general main headers/categories:
Fig. 9.4 A process map of pediatric cardiac and cardiac surgical care. Preoperative processes
Fig. 9.5 A process map of pediatric cardiac and cardiac surgical care. Operative processes
Fig. 9.6 A process map of pediatric cardiac and cardiac surgical care. Postoperative processes
place (environment), equipment, procedures and value. The data can be related to patients, organi-
methods (processes), people (patients and zations, or clinical units. Run charts are particu-
providers), and policies (Fig. 9.8) [39]. Routine larly useful because they can reveal subtle
root cause analysis with Ishikawa diagrams can changes over time that would otherwise go
be very powerful in analyzing surgical adverse noticed. A run chart is a graphic representation of
events. A detailed analysis in one major hospital process performance data tracked over time and
over 4 years (Table 9.1) established the fact that represents continuous data. Important uses of the
excellent surgical outcomes depend on integrat- run chart for improvement are to:
ing individual, team, technical, and organiza-
tional factors [40]. • Display data to make process performance
Reviewing the root cause categories helps the visible
team estimate the resources needed to address the • Determine whether tested changes improve
causes of process variation. These diagrams help the process or endpoints
identify potential improvements and which • Determine whether the changes are lasting
improvements might be transferable to another • Allow for a temporal view of data versus a
setting. static view [43]
For example, a team wanting to improve patient

Run Charts and Control Charts outcomes might measure time to extubation for
patients undergoing closure of an atrial septal
Two of the most powerful CQI tools are run defect or ventricular septal defect. Team members
charts and control charts [10, 41]. These tools are start by plotting the data over time in a run chart
valuable for analyzing variability in clinical pro- for 30 consecutive patients (Fig. 9.9), where the
cesses [42], in part because the data usually does time to extubation ranged from 2 to 48 h after the
not go beyond what is generally collected to meet procedure, with a median of 14 h. As the team
reporting requirements. changes the process, they can continue plotting
The run chart is a simple plot of a measure- data to determine whether the changes decreased
ment over time with a line drawn at the median time to extubation and thus improved overall care.
Fig. 9.7 A process map showing minor and major adverse event data in pediatric cardiac surgery [36]
The control chart was developed by Shewhart Shewhart and Deming defined two types of
in the 1920s to improve industrial manufacturing variation in a process. Briefly, “common cause
[10]. Like run charts, control charts display data variation” is the usual, historical, quantifiable
over time, but control charts provide upper and variation in a system, whereas “special cause
lower control limits of variation that help deter- variation” is unusual, not previously observed,
mine whether a process is stable or unstable nonquantifiable variation [44]. In surgical proce-
(Fig. 9.10). Control limits are calculated using dures, common cause variation might include
median values and the moving ranges of the data. fluctuations in the severity of a patient’s risk fac-
The factors leading to instability must be tors, the skills of operating team members, or
addressed before the process can be improved. changes in equipment settings [45]. Common
Fig. 9.8 An Ishikawa diagram for pediatric cardiac surgery [16]
Table 9.1 Results of a surgical adverse event root cause Theme Issues identified
analysis
Access to emergency • Antepartum hemorrhage
Theme Issues identified operating room and emergency cesarean
Failure to recognize or • Postsurgery • Urgent orthopedic
respond appropriately to complications procedure
the deteriorating patient • Postoperative sepsis • Urological complications
within the required time • Postoperative requiring urgent OR
frame hyponatremia Missed diagnosis • Thoraco-lumbar fracture
Workforce availability • Orientation, training, and in a trauma patient
and skills supervising new or • Brain abscess mistaken
junior members of the for cerebral metastasis
surgical team, • Subarachnoid
especially outside hemorrhage thought to
normal working hours be drug overdose
Transfer of patients for • Difficulty in organizing Unexpected procedural • Airway obstruction after
surgery an OR for surgery complications thyroidectomy
• Failure to hand over • Failed intubation
information about Sentinel events • Wrong-site procedure—
patient acuity spinal fusion at wrong
Trauma management • Coordination and response level
of trauma teams • Retained surgical
• Clinical decision-making products requiring
process for trauma patients surgical removal
• Coordination of care Adapted from Cassin B, Barach P. Making sense of root
between multiple cause analysis investigations of surgery-related adverse
clinicians events. Surg Clin North Am 2012:1–15. doi:10.1016/j.
(continued) suc.2011.12.008
Fig. 9.9 A run chart of time to extubation for patients undergoing closure of atrial septal defect and ventricular septal
defect in the ICU
Fig. 9.10 A control chart of time to extubation for special cause variation. That is, without any changes to
patients undergoing closure of atrial septal defect and ven- the process, the time to extubation will continue to fall
tricle septal defect in the ICU. The chart shows that the within a range that will not exceed the upper control limit
variation is the result of common cause variation and not of 55 h
cause variation suggests that improving outcomes of variation, which can then be eliminated to
will require changing the processes that produced bring the process back under control (Fig. 9.8).
the results. Special cause variation is the result of These data can inform the team about when to
factors extraneous to the process, for example, act, but also, especially in systems that are con-
variation introduced by a new manager, drive for stantly tweaking their systems, when to hold and
more productivity, or equipment breaking during not to act, depending on the cause of the
a procedure. It is not possible to predict (or con- variation.
trol) variation caused by special causes [46]. The control chart illustrates the variation that
If the control chart indicates that the process is is due to a common cause and not to a special
currently under control (i.e., it is stable, with vari- cause variation. What this means in our example
ation only coming from sources common to the about when to extubate the patient is that without
process), then data from the process can be used any changes to the process it will be difficult to
to predict the future performance of the process. predict the time to extubation and if it will con-
If the chart indicates that the process is not under tinue to fall within a range that does not exceed
control, the chart can help determine the sources the upper control limit (of 55 h).
Control charts are appropriate for analyzing 7. Small DS, Barach P. Patient safety and health policy:
a history and review. Hematol Oncol Clin N Am.
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on the development of an overarching strategy to cre-
processes and outcomes of surgical patient care. ate alignment, drive clinician and staff engagement
Detailed descriptions of how to apply the tools for continuous quality improvement and document
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atric cardiac surgery. Prog Pediatr Cardiol.
tools are used but about how these tools can pro-
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members, and track patient progress. Their pur- Breizat AH, Dellinger EP, Herbosa T, Joseph S,
pose is to help people function as a team, as well Kibatala PL, Lapitan MC, Merry AF, Moorthy K,
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Suppl 1:i97–105.
The Future and Challenges
of Surgical Technology 10
Implementation and Patient
Safety
Chandler D. Wilfong and Steven D. Schwaitzberg
“To raise new questions, new possibilities, to regard old problems from a new angle,
requires creative imagination and marks real advance in science.”
—Albert Einstein
Surgery is a rapidly evolving field with advancing Surgical, Sunnyvale CA, USA) is a computer-
techniques and technologies driven by innovation assisted robotic surgical system that is widely
and research. The current state of surgery is chang- employed in various surgical specialties. The da
ing with a focus on robotics, advanced minimally Vinci® Surgical System is not technically a robot,
invasive techniques, new operative equipment, but a computer-assisted telemanipulator. The sur-
and educational techniques including telesurgery geon generally sits at a console within the same
and telementoring, as well as promising fields operating room and directs the robotic arms to
such as tissue engineering and nanosurgery. perform minimally invasive surgical procedures.
The computer system enhances the surgeon’s
abilities by scaling the movements of the sur-
he Current State of Robotic
T geon’s hands to articulating surgical instruments,
Surgery as well as reducing tremor, allowing a full range
of motion that is not possible with current laparo-
Robotics within the field of surgery brings three scopic instruments. These functions theoretically
obvious capabilities to the surgeon. They are allow the surgeon to perform more complex
tremor reduction, scaling, and wristed articulation maneuvers and surgical procedures. A second
at the level of the tissue especially in small spaces. operative console is available to allow surgeons to
These inherent features of robotic should not be work in tandem in a training configuration within
contiguous with product features and options that the same procedure. There are further optional
the various medical devices will feature on the technologies that couple with the platform such as
market. The da Vinci® Surgical System (Intuitive Firefly™ imaging technology. Indocyanine green
(ICG) dye is injected into the bloodstream. A
C.D. Wilfong, MD
near-infrared laser (803 nm) illuminates the tissue
Department of Surgery, SUNY University at Buffalo, where the dye is excited and fluoresces, showing
Buffalo General Medical Center, blood vessels as well as the biliary tree (Fig. 10.1).
100 High Street, Buffalo, NY 14203, USA The da Vinci® Surgical System is widely
employed across multiple surgical specialties to
S.D. Schwaitzberg, MD (*) perform minimally invasive procedures such as
Department of Surgery, University at Buffalo School
of Medicine, 100 High Street, Buffalo, prostatectomy, gynecologic procedures, gastroin-
NY 14203, USA testinal procedures such as Heller myotomy,
e-mail: [email protected] Nissen fundoplication, gastric bypass, colectomy,

134 C.D. Wilfong and S.D. Schwaitzberg
Fig. 10.1 The renal

hilum, Intuitive Surgical
rectal surgery, hepatic, and pancreaticobiliary sur- robotic assisted procedures were performed
gery. The Society of American Gastrointestinal worldwide in 2013; yet despite the widespread
and Endoscopic Surgeons Technology and Value incorporation of robotic procedures, the added
Assessment Committee reviewed the safety and benefit versus cost remains unclear. Insurance
efficacy of robotic assisted surgery in gastrointes- providers generally reimburse robotic procedures
tinal procedures in July 2015. A comprehensive at the same level as laparoscopic cases, despite
review of current available literature demon- the increased cost of using the robot system, such
strated a non-inferiority in all reviewed gastroin- as required service charges by the robotic com-
testinal surgeries; however, a demonstrable benefit pany, as well as increased consumable charges
in improved surgical outcome or decreased length associated with each procedure. Schwaitzberg [1]
of stay was not observed. investigated the financial viability of performing
There are a number of current trials investigating outpatient, robotic assisted procedures on the
the efficacy of robotic surgery, particularly in pelvic current platform and concluded that, depending
surgery, across multiple specialties. The ROLARR on payer source, it is unlikely that robotic assisted
trial is an ongoing international, multicenter, ran- outpatient procedures can be financially viable
domized, controlled, unblended, parallel group trial until such time that acquisition and tooling prices
of robotic total mesorectal excision (TME) versus come down to a lower price point (Fig. 10.2).
laparoscopic total mesorectal excision. The benefits The future of robotic surgery will undoubtedly
of laparoscopic TME compared to open TME have include a variety of platforms outside of the cur-
been evaluated in multiple studies, and there are rently employed console-based platform.
clear short-term benefits to a minimally invasive Miniature robots will most certainly play a role in
approach. The da Vinci® surgical system offers the- advancing minimally invasive surgical tech-
oretical benefits when operating in the confined niques of the future. These robots will be
area of the pelvis, which could translate into a deployed through a small primary incision and
decrease in the technical difficulties associated with will be configured inside of the abdomen or chest
laparoscopic TME. Many centers are employing or specialize functions and controlled wireless
robotic procedures based on these theoretical bene- fully from the exterior. In addition, the opportu-
fits. The ROLARR trial is a practical trial designed nity for non-console robots really functioning as
to evaluate the benefits of robotic TME. specialized hand instruments will bring these
Robotic surgery is associated with an inherent capabilities on an as-needed basis to selected
increase in procedural costs. Over 500,000 portions of the procedure.
10 The Future and Challenges of Surgical Technology Implementation and Patient Safety 135
Fig. 10.2 The future of robotic surgery will undoubtedly include a variety of platforms outside of the currently
employed console-based platform
The ARES, or Assembling Reconfigurable scopic myotomy (POEM) for the treatment of
Endoluminal Surgical system (Scuola Superiore di achalasia and endoluminal mucosal as well as
Studi Universitari e di Perfezionamento Sant’Anna), full-thickness resections are already being per-
is a prototypical, ingestable, component-based min- formed. For instance, in Asia endoscopic resec-
iature robotic platform that the patient ingests in tion of very early malignancies is routinely
multiple components. The components then assem- performed on therapeutic endoscopic platforms.
ble within the fluid-distended gastric lumen to per- Further advancements in endoluminal therapies
form procedures. The theoretical applications for are on the forefront of surgery.
this platform are wide ranging, but could include NOTES or surgery through natural orifices of
pH sampling, biopsies, direct optical vision, and the body, often referred to as “incisionless” sur-
even DNA analysis (Fig. 10.3). gery, has the potential to eliminate complications
The hurdles in implementing newer robotic associated with incisions in surgery. There are
technologies in vivo are many, including the several proposed benefits to patients with these
power source, location monitoring, tool payload, approaches including decreased postoperative
maneuverability, propulsion but also important pain, shorter hospital stays, faster postoperative
human factors and ergonomic aspects addressing recovery, and elimination of surgical site infec-
human limitations [2]. tions and abdominal wall hernias. Performing
surgery via transvaginal, transgastric, and trans-
anal approaches is appealing, but is not a widely
Endoluminal Surgery and NOTES adopted practice at this time. There are many
technical challenges associated with NOTES sur-
Current trends and surgery and therapeutic gery, however, particularly associated with the
endoscopy suggest that these fields are intersect- technical difficulty of the procedures given the
ing to perform certain types of procedures in an current instrument technologies. The majority of
increasingly less invasive fashion. This intersec- NOTES procedures are therefore performed as
tion will require the development of new devices hybrid procedures with laparoscopic assistance.
in order to perform these innovative procedures. There is a large amount of variation present in
Endoluminal techniques such as per oral endo- NOTES procedures at this time. The route of
Fig. 10.3 The hurdles in implementing this technology in vivo are many, including the power source, location monitor-
ing, tool payload, maneuverability, and propulsion
entry: transgastric versus transvaginal, rigid versus Analysis of current NOTES literature does
flexible endoscopes, and the number and site of support a prolonged operative time in both hybrid
access points: True NOTES versus hybrid notes NOTES and total NOTES procedures. Chellali
with laparoscopic assistance. A literature review et al. [3] reviewed a series of NOTES cholecys-
by Chellali et al. [3] showed that 90 % of NOTES tectomies recorded on video and surmise that the
procedures reported are performed with hybrid prolonged operative time is, at least in part, a
laparoscopic assistance, and that a transvaginal result of instrumentation that is not adequately
approach was employed in the majority of cases designed for these newly appointed tasks [4].
(86 %). The most common procedure performed Reviewed the currently available multibranched
was cholecystectomy, comprising 84 % of reported laparoscopic and endoscopic instrumentation in
cases. The Society of American Gastrointestinal light of the criteria suggested by NOSCAR find-
and Endoscopic Surgeons (SAGES) created the ings. Future facilitation of NOTES procedures
Natural Orifice Surgery Consortium for will require the design and implementation of
Assessment and Research (NOSCAR) in order to less cumbersome instruments that will allow the
assess the feasibility and safety of NOTES proce- surgeon to perform more complex bimanual tasks
dures. EURO-NOTES was also established in requiring triangulation, such as intracorporeal
Europe to serve similar purposes. A review of cur- suture tying.
rent literature does not clearly establish the role or POEM is a procedure in which a gastroesoph-
safety for NOTES procedures, although it does ageal myotomy is made using a therapeutic endo-
provide a proof of concept with hundreds of proce- scope via a transmucosal incision in the
dures performed. NOSCAR is currently investi- mid-esophagus for the treatment of achalasia. A
gating the efficacy of NOTES cholecystectomy in submucosal tunnel is made along the length of
a multicenter human clinical trial in the USA. the esophagus and the circular muscle fibers are
incised, performing the myotomy. POEM was real-time advice on the procedure, including
initially described in 2008 by Inoue, and has sub- telestration capabilities. Previous studies have
sequently come to be performed in more than 50 demonstrated equivalent levels of skill acquisi-
centers worldwide. Several studies comprising tion between surgeons that were remotely men-
hundreds of patients have been reported, con- tored and locally mentored in laparoscopic
firming the safety and efficacy of POEM. The nephrectomy, Nissen fundoplication, and laparo-
success rates of achalasia treatment using POEM scopic colectomies. This demonstrates the poten-
are greater than 90 %, generally evaluating the tial of telementoring to provide surgeons with the
symptoms using the Eckhart score. Postoperative ability to further their training throughout their
gastroesophageal reflux symptoms have been career irrespective of the availability of local
reported in patients greater than 1 year postoper- expert mentors. Other questions arise around
atively at rates between 35 and 40 %. These how best to prepare/rehearse given potential evi-
results are consistent with postoperative reflux dence about optimal techniques for performing
rates in laparoscopic Heller myotomy. POEM physical rehearsal and warm-up. Preliminary
represents a minimally invasive, incision-free findings suggest that preoperative rehearsal or
alternative to laparoscopic Heller myotomy that warm-up can improve the performance of opera-
has been reported as successful treatment in tors or operating teams, but there is a paucity of
nearly all types of achalasia, including patients objective evidence and comparative clinical stud-
with previous interventions, as well as patients ies in the existing literature to support their rou-
with sigmoid esophagus. tine use [7].
There is debate about the relationship between
the telementor and practicing surgeon, and there-
Telesurgery and Telementoring fore the liability of the mentor. Some argue that the
mentor is directly involved in intraoperative deci-
The widespread adaptation of minimally invasive sion making, and therefore responsible for patient
techniques faces several hurdles. One of the larg- care. Other parties believe that the responsibility
est hurdles involves the dissemination of tech- lies with the primary surgeon, and the mentor is
niques and skills outside of residency training to only advising the primary surgeon, and not liable
surgeons in the community. Residency training for patient care or outcome [8]. Currently, it is
represents the ideal setting for educating sur- important that the primary surgeon be able to com-
geons under the direct oversight of experienced plete the procedure on his/her own, and that the
surgeons on a day-to-day basis. New technolo- mentor be present for guidance on optimal tech-
gies and techniques are constantly under devel- nique. Regardless, telementoring represents an
opment throughout a surgeon’s career. There is a avenue for continuing education and live intraop-
need to develop robust and validated assessment erative training of surgeons, without regard to geo-
tools for surgical competency given growing graphic boundaries for the future (Fig. 10.4).
potential for patient harm with more advanced Simulation-based training in conjunction with
surgical tools [5]. The current method for a sur- deliberate practice activities such as reflection,
geon to learn a new technique frequently involves rehearsal, trial-and-error learning and feedback
a course or simulation that is insufficient to fully in improving the quality of patient care will
develop the necessary skills. A novel approach to become mainstream in assessing expertise [9].
the continued training of practicing surgeons has
been implemented by a number of groups, includ-
ing Ponsky et al. as described in 2014 [6]. The The Future of the Operating Room
Karl Storz VisitOR1 telementoring robot cart
was used to stream the procedure to a virtual The operating room of the future will revolve
mentor experienced in the procedure. The around integrated technology. Current modern
VisitOR1 robot cart allows the mentor to provide advances present in many operating rooms
signs, documentation, and procedure-related

imaging in real time in the operating room.
Hybrid operating rooms are being widely
employed across the USA in multiple fields,
particularly cardiovascular surgery, vascular sur-
gery, neurosurgery, and orthopedic surgery.
Vascular and cardiovascular surgeons routinely
perform hybrid procedures that involve endovas-
cular interventions with more traditional surgical
procedures to treat disease processes involving
the heart valves as well as peripheral vascular
disease, and others [12]. Hybrid operating suites
have rapidly become the standard of care for vas-
cular surgeons performing stent graft repair of
abdominal aortic aneurysms as well.
Trauma surgery represents an area of growth
for hybrid operating suites in the future. Traumatic
injury remains one of the most potentially pre-
ventable causes of death in modern society, and
exsanguination represents the most potentially
preventable cause of death in traumatically injured
patients who arrive at the hospital. Modern trauma
systems and advances in surgical care means that
the most commons sites of life-threatening hem-
orrhage are extra-abdominal sites, such as the pel-
vis, which often require interventional procedures
in order to obtain hemostasis. Trauma surgeons
are often faced with the difficult decision requir-
ing triage of the exsanguinating patient to either
the operating room or the angiography suite.
Hybrid operating suites designed to treat the
Fig. 10.4 VISITOR1 mobile telementoring system. exsanguinating patient, such as the RAPTOR
®
©2016 Photo Courtesy of KARL STORZ Endoscopy- (resuscitation with percutaneous treatments and
America, Inc. operative resuscitations) suite described by
Kirkpatrick et al. [13], have the potential to offer
revolve around decreased level of invasiveness in life-saving therapy to patients with life-threaten-
surgical procedures [10]. Minimally invasive ing injuries in multiple sites at the same time, and
technologies such as image-guided procedures, will likely grow in number in the future. The
telesurgery, hybrid vascular procedures, robotic RAPTOR operating room is designed to function
surgery, and single-incision or natural orifice as a location for resuscitation, imaging, interven-
laparoscopic procedures are becoming more tional radiology, as well as open surgery.
prevalent, and with them their associated techno- Currently, there are no studies to support the use
logical advancements. Procedures that have of hybrid operating suites in trauma resuscitation;
always required a traditional operating room set- however, despite the high cost of instituting the
ting will now demand advanced imaging capabil- technology, there are select centers around the
ity along with endoscopic technologies [11]. world that are implementing the technology.
Surgeons, OR staff, and anesthesia staff will want However some adjunctive technologies in the
access to up-to-date patient information, vital operating room of the future may be helpful such
as automated sponge counting technology using have shown them to augment wound healing
methods such as RFID tracking or radiofrequency through increased vascularization and cellular
detection of retained surgical sponges in the abdo- infiltration. Preclinical models have shown that by
men/chest. The future of the operating room is harvesting adipose-derived stem cells and seeding
also a future of improved workflows and enhanced acellular meshes prior to hernia repair, the meshes
patients’ safety. Trauma hybrid rooms are going to achieve more rapid vascular and cellular infiltra-
require more awareness and attention to the team tion into the native tissues. Explantation of the
functions, communication and ability to work repaired hernia in a preclinical rat model also
seemlesslly together [14]. These opportunities demonstrated improved tensile strength in com-
have less to do with technological advances as parison to acellular dermal mesh controls. The
they do with human advances. The checklist, pre- ideal mesh would provide tensile strength equal to
operative briefing, and postoperative debriefing the normal architecture of the abdominal wall and
are all examples of needed human engineering also incorporate into the tissues of the patient.
advances in the field of team work and communi- Tissue-engineered meshes may one day provide
cation as noted in other chapters of this book. improved materials for hernia repair.
Stem cell and mature cardiac myocytes have
been investigated in multiple different iterations
Tissue Engineering in conjunction with cardiac patches to repair con-
genital heart defects. The theoretical benefits of a
Tissue engineering is a broad multidisciplinary tissue-engineered patch have the potential to over-
field that originated with the goal of developing come the shortcomings of purely synthetic car-
complex tissues and organs in order to facilitate diac patches. The materials currently used are
patient treatment, particularly those with end- nonliving, noncontractile, not electrically active,
organ failure. Tremendous strides have been and do not have the ability to grow with the
made in the field of transplant surgery; however, patient. The complications associated with these
there remains a much larger need for organ trans- features include potentially fatal arrhythmias and
plantation than there is a supply of donor organs. high re-operative rates as the patients grow lead-
Many advances have been made over the last ing to a risk of sudden cardiac death 25–100 times
two decades in the field of tissue engineering, higher than the normal population. A tissue-
with the potential to have a large impact on the engineered approach to repair of congenital heart
practice of surgery in the future. Surgeons, in par- defects that can contract, integrate electrically,
ticular, possess the skill sets that will allow the and fully incorporate and grow with the patient
implementation of the technology created by tis- has the potential to eliminate these risks. There
sue engineering. are many obstacles to overcome in order to create
Approximately 250,000 ventral hernia repairs such a functional implant.
are performed each year in the USA alone, and Multiple products based on tissue engineering
even with modern techniques employing syn- concepts are available for use in the USA in the
thetic mesh implantation, recurrence rates remain field of wound care. Apligraf and Dermagraft are
as high as 20 %. Synthetic polypropylene-based products based on temporary scaffolding materi-
meshes elicit significant inflammatory response als seeded with human neonatal foreskin fibro-
when incorporated into a hernia repair, however, blasts that are approved by the FDA for treatment
resulting in dense scar and adhesion formation. of burns, diabetic foot ulcers, as well as chronic
Acellular dermal mesh products have been shown venous stasis ulcer disease. OrCel is a skin sub-
to incorporate into the host tissue and result in stitute composed of neonatal keratinocytes and
fewer omental adhesions in preclinical models, fibroblasts on a bovine collagen sheet that has
but have high hernia recurrence rates. Adipose- been shown to improve wound healing and
derived stem cells have been shown to have excel- reduce scarring compared to traditional dress-
lent regenerative capabilities and multiple studies ings. Despite the benefits of using these products,
the neonatal cells only persist on their engineered via various mechanisms. Several immunother-
matrices for a period of weeks. The next genera- apy strategies have evolved over the last decade
tion of biologic wound care dressings are likely targeting these mechanisms within the tumor
to incorporate autologous stem cells into engi- microenvironment.
neered scaffolds to promote skin regeneration. Adoptive cell transfer of tumor-infiltrating
A large number of studies exist confirming the T-lymphocytes has been evaluated in multiple
ability to use stem cells to produce functional cells solid malignancies, particularly melanoma, as
of the body with a range of success. The current described by Rosenburg et al. in multiple studies.
clinical applications of these cells have generally A host tumor is harvested and the tumor-infiltrating
failed to show long-term improvements in out- T-lymphocytes are isolated, and then expanded
comes, largely due to the inability of the cells to ex vivo. The tumor-infiltrating T-lymphocytes are
fully mature and function in the complex system of then infused into the patient, following patient
the human body. Research has turned to utilizing lymphodepletion to enhance tumor response.
scaffolds to provide the stem cells with structure Patients with metastatic melanoma demonstrate
and promote incorporation. Another issue in trans- response rates from 49 to 72 %, with a complete
lating stem cell research from in vitro models to durable response in up to 40 % of patients, extend-
in vivo applications is the issue of vascularity. An ing beyond 3–7 years. Response rates in these
implanted conduit would require a robust blood patients are independent of previous treatment
supply, and the formation of a de novo blood sup- strategies. Solid malignancies other than mela-
ply is poorly understood. The possibility of graft- noma present a challenge in using this strategy,
ing stem cells into a “free flap” has been however, because they demonstrate significantly
demonstrated in preclinical models. Decellularized lower number of tumor-infiltrating T-lymphocytes.
organ scaffoldings have also been examined in car- The ability to genetically engineer T-cells has pre-
diac, lung, and liver models with success in institut- sented the opportunity to apply adoptive cell trans-
ing partial organ function in in vitro models. fer to a wider range of solid malignancies, with
Surgeons will need to develop new skills that ongoing evaluation of colorectal cancers, prostate
needed to implement these technologies in the cancer, sarcomas, and others.
future, indicating a continued need for collabora- Checkpoint blockade therapy including
tion between tissue engineers and surgeons to CTLA-4 inhibitors and PD-1 inhibitors has been
bolster the field of regenerative surgery. shown to be effective in treating metastatic mela-
noma and is currently being evaluated for effi-
cacy in multiple solid malignancies. Combination
Immunotherapy in Surgery therapy involving both CTLA-4 and PD-1 inhibi-
tors in early clinical trials have shown a response
Knowledge of the interaction between cancer and rate of 40 % in advanced metastatic melanoma,
the immune system has increased substantially with an acceptable side effect profile.
over recent years and corresponding improve- Advances in immunotherapy present an
ments in immunotherapy have followed. emerging therapeutic option for patients with
Surgeons play an integral role in these treatment advanced solid malignancies that are resistant to
strategies and knowledge of immunology and conventional therapies. Adoptive cell transfer
immunotherapy treatment options will become represents a treatment option that is limited to
increasingly important in the coming years. large centers, although it is continuing to be
Advanced solid tumors have historically had offered at more institutions. Checkpoint blockade
poor outcomes despite maximal therapy. Despite therapy represents an immune-based chemother-
immune system recognition, as well as surgical apeutic option that can be widely incorporated
and cytotoxic therapies, the tumor microenviron- into multidisciplinary approaches in a wide-
ment represents an immunosuppressed environ- spread setting, with surgeons being an integral
ment that allows tumor growth and progression part of the treatment approaches.
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Part II
Job and Organizational Design
Organizational and Cultural
Determinants of Surgical Safety 11
Kathleen M. Sutcliffe
“Judges possessing outcome knowledge may, for example, tend to reverse their temporal
perspective and produce scenarios that proceed backward in time, from the outcome to
the preceding situation. Such scenario retrodiction may effectively obscure the ways in
which events might have taken place, much as solving a maze backward can obscure the
ways in which one might have gotten lost entering from the beginning.”
—Fischoff, 1975, p. 298
safety literature [2]. This cumulative body of

Introduction research provides some insight into how organiz-
ing and culture might enable safe care. Although
This chapter explores some fundamental ideas health care has enthusiastically sought to craft
about organizational and cultural determinants of interventions based on this research, the enthusi-
surgical safety. We propose that the success of asm for interventions in some cases has out-
individuals and teams involved in providing safe stripped the evidence supporting them ([3]: 1).
and reliable care is more or less fueled by orga- That is, even with respect for the best of intentions
nizing processes and the cultures in which care- this enthusiasm sometimes has led to superficial
givers are embedded. By privileging process and application of particular ideas without a solid
culture we offer a systemic lens on the underpin- grasp either of the underlying concepts or the
nings of safety in complex healthcare systems mechanisms through which they exert their influ-
and move beyond medicine’s prevailing focus on ence [4, 5].
individual excellence and achievement as the In this chapter we aim to remedy this state of
sole means to assuring safe and reliable care. affairs. We are mindful that innovations are best
The ideas discussed in this chapter derive from designed by people who have deep contextual
years of research exploring the problem of safety knowledge and are close to the work. Thus, we
in complex sociotechnical systems in disciplines do not aim to be prescriptive. Rather the intention
such as organization and management theory, is to provide a general and wide-ranging over-
cognitive psychology, sociology, and human fac- view of some basics related to processes of orga-
tors engineering. Research from these disciplines nizing and culture. By enriching understanding
over the past two decades, possibly as a conse- of these essentials, we hope that clinicians will be
quence of the IOM’s To Err is Human [1] advis- better prepared to contextualize these ideas and
ing health care organizations to attend to the more successfully apply them to their own surgi-
wisdom of organizations in high-hazard cal care improvement efforts.
industries, has begun to penetrate the patient
The chapter unfolds as follows. We start by
examining some basic assumptions related to the
challenges of achieving safety in complex,
K.M. Sutcliffe, PhD (*)
dynamic, open systems. We follow with a discus-
Carey Business School, Johns Hopkins University,
100 International Drive, Baltimore, MD 21202, USA sion of two orientations toward safety, essential
e-mail: [email protected] organizational processes and practices, and

146 K.M. Sutcliffe
e vidence linking these to outcomes. We then turn of any entity [9, 10]. Safety is a moving target:
to the concepts of safety culture and safety cli- A good day yesterday does not necessarily mean
mate. We explore how they are defined, how they a good day today.
exert their influence, and how culture and cli- Third, safety is a dynamic non-event [11]. It is
mates are enabled, enacted, and elaborated. We dynamic in the sense that safety is preserved by
follow with some evidence linking safety climate timely human adjustments; that is, problems are
and outcomes. We end with some implications fleetingly under control due to compensating adap-
for practice and concluding comments. tations. It is a nonevent because successful out-
comes rarely call attention to themselves. In other
words because safe outcomes do not deviate from
Open System Assumptions what is expected, safety is in some ways invisible.
When there is nothing to capture people’s attention,
It is important to keep our eye on some key they see nothing and they presume that nothing is
assumptions about complex sociotechnical sys- happening and that nothing will continue to happen
tems and their safety, as they are critical for if they continue to act as they have acted before.
understanding the bounds of organizational and A fourth assumption is that adverse events and
cultural interventions. First, when people in health outcomes in health care sometimes occur because
care refer to systems or systemic error, they often of mistakes in performance and execution, but mis-
have in mind a rational closed mechanical system takes in perception, conception, and understanding
comprised of explicit roles, rules, routines, and more often lead to unsafe conditions and ultimately
relationships intentionally created to achieve to greater harm [12, 13]. This is nicely captured by
some well-defined objective. In closed systems, sociologist Marianne Paget’s [14] observation that
“goals are known, tasks are repetitive, output of medical work unfolds in real time and is “an error-
the production process somehow disappears, and ridden activity … inaccurate and practiced with
resources in uniform qualities are available” ([6]: considerable unpredictability and risk.”
5). But health care systems defy that description. Finally, most accidents and failures in com-
Viewing systems as closed or mechanical misses plex systems are not the result of the actions of
the fact that much medical care is delivered by any single individual (even though there is a ten-
transient, temporary teams, assembled in various dency to blame single individuals). Nor are they
contexts (e.g., the operating room or at the bed- the result of a single cause [15]. Small incidents
side), and often with new or unfamiliar players often link together and expand [10]. This is why
(e.g., rotating interns/residents, floating nurses) it is important to be able to catch and correct
([7]: 169). Transient systems have to be continu- small mistakes and errors before they grow big-
ally reconstituted. Viewing systems as closed also ger. When problems are small, there are often
overlooks the fact of equifinality—meaning that more ways to solve them. When they get bigger,
the same results may be achieved with different they tend to get entangled with other problems
initial conditions and through many different and there are fewer options left to resolve them.
paths or trajectories. Although health care organi- Together these assumptions highlight the chal-
zations are loosely coupled [8] in the sense that lenges of safety and reliability in complex sys-
their various parts work fairly independently, tems (see Box 11.1). Achieving safe and reliable
patient outcomes often are determined by the outcomes in error-ridden, unpredictable open
combined product of these constituent loosely systems such as those found in health care means
coupled parts. accepting the realities of dependence, loose con-
A second important assumption is that sys- nections, keeping up with environmental
tem safety is an illusory concept. There are no demands, redoing processes and structures that
safe systems/organizations if only because past keep unraveling, and expecting the unexpected
performance cannot determine the future safety [16]. But that doesn’t mean that people who
11 Organizational and Cultural Determinants of Surgical Safety 147
afety in Health Care: The Role

S
Box 11.1: Safety Challenges in Complex of Organizing Processes
Open Systems
• There are big differences between closed Researchers have identified a number of proper-
and open systems and these matter for ties of safe and reliable organizations. Although
safe care. Health care systems are open the specific attributes vary between studies, there
and loosely coupled; their various parts are a number of commonalities. Many properties
work independently, but outcomes are such as good technology and task and work
determined by the product of these parts. design, highly trained personnel, well-designed
• In open systems there is equifinality; the reward systems, continual training, frequent pro-
same results may be achieved with dif- cess audits, and continuous improvement efforts
ferent initial conditions and through are ubiquitous. Research outside of health care
many different paths. There is no one for several decades has linked bundles of these
right way to organize in open systems. properties to higher performance [18], and
• System safety is an illusory concept. research in health care also suggests that these
There are no safe systems and organiza- elements matter. For example, in a study of 95
tions because past performance cannot hospital nursing units Vogus and Iacobucci [19]
determine the safety of any entity. found that the use of a bundle of organizational
• Safety is a dynamic nonevent. Safety is work practices that included rigorous selection of
dynamically preserved by timely human employees (particularly for interpersonal skills),
adjustments. Safety is a nonevent extensive and regular training and development,
because successful outcomes do not call and continuous work process improvement activ-
attention to themselves. Just because ities was directly and indirectly associated with
nothing is happening does not mean that fewer medication errors and patient falls. These
nothing is being done to make that hap- basic organizational features, similar to those that
pen. We never have a complete under- one would find in any high-performing organiza-
standing of all the factors that are tion, although necessary to safety and reliability
keeping a unit/organization safe. are not sufficient. Although these properties may
• Medical work is a dynamic unfolding provide the scaffolding for other critical organi-
activity. Mishaps and adverse outcomes zational processes and outcomes [19], in some
may be a result of problems with execution ways we might think of them as contingencies or
and performance, but misperceptions, mis- boundary conditions. Their presence (or absence)
conceptions, and misunderstandings ulti- strengthens (weakens) the effects of other deter-
mately lead to greater harm. minants. Consequently, in this chapter we are
• Most accidents and failures do not result more concerned with the distinctive properties
from a single cause or the actions of a sin- found in what are known as high-reliability orga-
gle individual. Small incidents often link nizations (HROs), prototypical organizations
together and expand. It is important to such as aircraft carriers, air traffic control (and
catch problems in their early stages when commercial aviation more generally), and nuclear
there are more ways to solve them. As they power-generation plants (see [20–22]) that oper-
get bigger the solution space gets smaller. ate complex technologies in complex, dynamic,
interdependent, and time-pressured social and
political environments.
Although diverse, studies have shown that
inhabit those systems are left helpless. In the fol- these high-risk organizations share a set of oper-
lowing section we explore organizational deter- ating commonalities and characteristics that
minants, particularly organizing processes and enable nearly error-free performance in settings
their role in producing dynamic nonevents [17]. in which errors should be plentiful (see Box 11.2).
148 K.M. Sutcliffe
efforts. But, more distinctively, the most highly

Box 11.2: Attributes of Highly Reliable reliable organizations are characterized by orga-
Organizations nizational processes and practices that foster an
• HROs exhibit attributes found in most organization-wide sense of vulnerability; a
high-performing organizations including: widely distributed sense of responsibility and
–– Outstanding technology and task and accountability for reliability; widespread concern
work design about misperception, misconception, and misun-
–– Exquisite selection mechanisms and derstanding that is generalized across a wide set
highly trained personnel of tasks, operations, and assumptions; pessimism
–– Effective reward systems about possible failures; redundancy; and a variety
–– Continuous training of checks and counter checks as a precaution
–– Frequent process audits and continu- against potential mistakes. In part, these distinc-
ous improvement efforts tive capabilities emerge from two complemen-
• HROs have distinctive properties tary logics to which we now turn.
including:
–– An organization-wide sense of
vulnerability wo Approaches to Safety
T
–– A widely distributed sense of respon- Management
sibility and accountability
–– Widespread concern and pessimism Broadly speaking, complex organizations pursue
about misperception, misconception, two basic logics to manage risks and achieve safe
and misunderstanding that is gener- and reliable (i.e., continually error free) perfor-
alized across tasks, operations, and mance. Wildavsky [23] contrasts these logics and
assumptions Schulman [12] analyzes them as they pertain to
–– Redundancy and a variety of checks health care. The first logic is one of anticipation/
and counter checks prevention. The second logic is one of resilience/
–– A climate and culture of trust and containment. We outline these two basic orienta-
respect tions in the following paragraphs.
–– Heedful coordination among people/ Anticipation/prevention. Advocates of antici-
units both upstream and downstream pation suggest that errors can be eradicated or
–– Habits of thought and action aimed precluded—that intolerance (e.g., zero defects)
at: of preventable harm is desirable and achievable
Examining failure as a window on [24] by using tools of science and technology to
the health of the system better control the behavior of organizational
Avoiding simplified assumptions members to perform safely and effectively. This
about the world requires organizational members and other stake-
Being sensitive to current unfolding holders (e.g., public, regulators) to define and
situations identify the events and occurrences that must not
Developing resilience to manage happen, identify all possible causal precursor
unexpected surprises events or conditions that may lead to them, and
Locating expertise and creating then create a set of detailed operating procedures,
mechanisms for decisions to migrate contingency plans, rules, protocols, and guide-
to those experts lines for avoiding or preventing them. A commit-
ment to anticipation and prevention removes
uncertainty; reduces the amount of information
HROs possess highly trained personnel, continu- that people have to process, which potentially
ous training, effective reward systems, frequent decreases the chances of memory lapses, judg-
process audits, and continuous improvement ment errors, or other biases that can contribute to
crucial failures; provides a pretext for learning; dures. Thus, although compliance with detailed
protects individuals against blame; discourages operating procedures is critical to achieving safe
private informal modifications that are not widely and reliable performance in many instances (e.g.,
disseminated; and provides a focus for any checklists for pre- and post-procedural briefings,
changes and updates in procedures [25]. or for reducing infection rates), partly because it
The logic of anticipation/prevention is based on creates operating discipline, blind adherence to
Perrow’s [26] notion of second-order behavioral rules can sometimes reduce the ability to adapt or
controls. Perrow [26] classifies control mecha- to react swiftly to surprises. Assuming that invari-
nisms into first order, second order, and third order. ant operating procedures and routines are the
First-order controls such as direct supervision, only means through which safe outcomes occur
inspection, or surveillance, although they are conflates variation and stability and makes it
expensive and reactive, are straightforward and more difficult to understand the mechanism of
obtrusive means for controlling behavior. Second- safe performance under trying conditions. Safety
order controls (i.e., bureaucratic controls) such as is broader and more far reaching. For a system to
standardization, specialization, and hierarchy are remain safe and reliable, it must somehow handle
more efficient than direct controls and are less unforeseen situations in ways that forestall unin-
obtrusive. In theory, they work by reducing the tended consequences. That is, it must organize
range of stimuli people have to attend to so that for transient reliability [17]. This means that it
they have fewer opportunities to make decisions must continuously manage fluctuations in job
that maximize personal interests rather than the performance, human interaction, and human-
organization’s interests. Third-order controls, also technology interaction, which necessitates capa-
known as control through culture (to be discussed bilities for resilience/containment.
more fully later in this chapter), are fully unobtru- Resilience/containment. A logic of resilience/
sive and work by controlling the cognitive prem- containment focuses on the ability to absorb
ises (e.g., norms, assumptions, values, and beliefs) strain, bounce back, and cope and recover from
that underlie action. challenging or untoward events. It also reflects an
The idea behind second-order control is that ability to learn and grow from previous episodes
consistent error-free outcomes will be produced of resilient action. Capabilities for resilience can
in the future if people repeat patterns of activity be traced to dynamic organizing practices (which
that have worked in the past. In routine, stable, themselves should become habits [28] or routines
certain situations, where tasks are analyzable and [22]). These organizing practices enhance peo-
repetitive actions can be identified and predict- ple’s alertness and awareness to details so that
ably will lead to desired outcomes, a logic of they can detect subtle ways in which contexts
anticipation makes sense. Naturally this descrip- vary and call for contingent responding. In other
tion fits some tasks, work roles, and work settings words, resilience works by increasing the quality
(e.g., laboratories, pharmacies) better than oth- of attention among the members of a unit, organi-
ers. But, it may not fit all. Certainly, recent zation, or system as well as increasing flexibility
research demonstrates the value of behavioral and capabilities to respond in real time, reorga-
routines (e.g., checklists) and standardizing work nizing resources and actions to maintain func-
(e.g., [27]). But, in nonroutine situations it is tioning despite peripheral failures.
sometimes impossible to write detailed operating Particular organizing principles and a micro-
procedures to anticipate all the situations and system of “mindful” organizing practices provide
conditions that shape people’s work. Moreover, the foundation for beliefs and actions in the safest
even if procedures could be written for every sit- and most highly reliable organizations. First,
uation there are costs of added complexity that highly reliable organizations are preoccupied
come with too many rules. This complexity with failures. Through various practices such as
increases the likelihood that people will lose flex- pre- (and post) procedural briefings (see [29]) for
ibility in the face of extensive rules and proce- example, they conduct proactive and preemptive
150 K.M. Sutcliffe
analyses of possible vulnerabilities, and pay ties for containment and recovery by seeking to
close attention to identifying and understanding understand expertise in their organization and
what needs to go right, what could go wrong, develop flexible decision structures. Through
how it could go wrong, and what has gone wrong, understanding and locating pockets of expertise
and why. Second, highly reliable organizations and creating mechanisms to shift decision mak-
avoid simplifying their assumptions about the ing to experts when problems begin to material-
world. They do this through practices that actively ize, highly reliable organizations increase the
seek divergent viewpoints, seek to question likelihood that capabilities will be matched with
received wisdom, uncover blind spots, and detect new problems and that emerging problems will
changing demands, for example through interdis- get quick attention before they grow bigger [31].
ciplinary rounding, purposely seeking additional In combination, these two approaches for
“eyes” for particular actions or procedures, or achieving safe and reliable performance enable
using exacting communication protocols that people and organizations to deal with inevitable
highlight what to look out for during transitions uncertainty and imperfect knowledge. That is, as
[30]. As an aside, it is important to note that we leaders and organizational members pay close
aren’t saying that organizations should not seek attention to the social and relational contexts in
to streamline or reengineer unwieldy processes; which they work; as they continuously and habit-
rather we are highlighting the fact that when peo- ually engage in everyday routines and practices
ple coordinate their actions in order to communi- and interact to develop, refine, and update shared
cate they tend to simplify their observations and understandings of the situations they face; and as
discussions. Thus they miss a lot. To build a more they develop their capabilities to act on those
complicated picture of the situations they face, understandings, they increase the likelihood that
highly reliable organizations try to complicate they will be able to prevent or avoid organiza-
their understandings. Third, highly reliable orga- tional mishaps (e.g., errors, adverse events) or
nizations are sensitive to what is happening right will be able to mitigate and cope with them and
now, how situations are unfolding. Their goal is their consequences as they unfold. In the follow-
to develop and maintain an integrated big picture ing section we explore some recent evidence of
of the current situation through ongoing attention the efficacy of these approaches to safe
to real-time information so that they can make a outcomes.
number of small adjustments to forestall the
compounding of small problems or failures. They
do this, for example, using huddles to preemp- Organizational Determinants
tively assess current situations so as to identify and Safe Outcomes: Some Evidence
vulnerabilities such as inadequate information,
staff, or resource shortages in order to make Research exploring organizational processes and
adjustments before harm is caused [31]. The their effects on outcomes has grown over the past
three principles discussed above focus on antici- several decades. For example, the president and
pation and prevention. Although highly reliable chief executive officer of the Joint Commission,
organizations seek perfection, they know they Mark Chassin, and his coauthor Jerod Loeb [32]
won’t achieve it and develop skills for resilience, have suggested that organizing processes and
recovery, and containment. practices have great purchase for enabling safer
Highly reliable organizations build resilience and more reliable health care. Theory certainly
primarily by enlarging response repertoires, has grown, but empirical research testing theory
through ongoing training and simulation, varied and particular hypotheses such as hypotheses
job experiences, learning from negative feed- related to criterion measures such as employee
back, and ad hoc networks that allow for rapid behaviors (e.g., procedural compliance, report-
pooling of expertise [19]. And finally, the most ing), patient and/or worker injuries, adverse
highly reliable organizations improve capabili- events, or other outcomes (e.g., litigation costs)
has lagged. Still evidence is beginning to accumu- reported extensive use of standardized care proto-
late and we describe some of the findings below. cols. Earlier we mentioned research by Vogus and
Knox and his colleagues [33] studied hospital Iacobucci [19] that showed positive associations
obstetrical units and found that those with better between bundles of organizing practices (e.g.,
safety performance and fewer malpractice claims selective staffing, extensive training, developmen-
were distinguished by particular organizational tal performance appraisal, decentralized decision
practices that included, among other things, spe- making), use of safety organizing processes, and
cific protocols for running shift nursing reports and performance reliability (e.g., reductions in medica-
physician sign-outs and frequent “decision- to- tion misadministration and patient falls). Moreover,
incision” drills (pp. 27–28). Roberts and colleagues engaging in these coordinative practices appeared
[34, 35] conducted a qualitative longitudinal study to enhance levels of trust and respect in communi-
of a pediatric intensive care unit (PICU) and found cations and interactions.
lower levels of patient deterioration in the unit To summarize, the above studies—consistent
were associated with the introduction of particular with findings from industries outside of health
organizing practices such as continual in-service care—support the idea that particular organiza-
training designed to help providers to interpret and tional attributes and organizing processes posi-
question data and working hypotheses and collab- tively influence safety and reliability. Other more
orative rounding by the entire care team that limited studies, for example studies of checklists
enabled increased sensitivity and a clearer under- and preoperative briefings (e.g., [29]: 1115–
standing of evolving patient and organizational 1117), also suggest that with relatively little cost,
situations. Finally, an action research study of five these kinds of processes can have salutary effects
intensive care units by Hales et al. [36] investigated on intermediate outcomes such as surgical flow
linkages between the introduction of particular disruptions, miscommunication events, and even
organizing practices and multiple forms of costs reduced waste.
and found evidence of a decrease in the number of We now turn our attention to safety culture and
negative incidents between a nurse and patient’s climate. Safety culture and climates are, in part,
family, a 50 % reduction in the number of failed by-products of organizational properties and inter-
nurse supervisor inspections, and a slight improve- related organizing processes and practices. Thus it
ment in patients discharged alive. However, for isn’t surprising that culture is frequently men-
other costs (e.g., patient length of stay, cost per tioned in studies emphasizing organizational pro-
patient) there were no effects. Ndubisi [37] found cesses. Still, safety culture is often discussed with
that three processes aimed at care reliability, infor- insufficient richness so that we can understand
mation reliability, and preemptive conflict handling how it works. In the following section we explore
were positively associated with hospital patient ori- culture, how it is defined and shaped, and how it
entation, satisfaction, and, in turn, patient loyalty in exerts its influence, and with what specific effects.
a hospital setting.
Vogus and Sutcliffe [38] in a large-sample study
of inpatient units similarly found positive benefits afety in Health Care: The Role
S
to particular safety organizing practices. Fewer of Culture and Climate
medication errors occurred over the subsequent 6
months on units that proactively and aggressively Just as culture is used to explain the orderliness
engaged in activities aimed at collecting, analyz- and patterning of much of our life experience,
ing, and disseminating information from errors as organizational culture is used to describe aspects
well as proactively checking on the unit’s vital of everyday life in organizations. Culture oper-
signs [38]. The negative association between safety ates as a “medium of lived experience” ([39]: 1),
organizing practices and medication errors was a system of symbols and meanings that both
stronger when registered nurses reported high lev- enables and constrains social practice and action
els of trust in their nurse managers and when units (e.g., [40, 41]).
152 K.M. Sutcliffe
Organizational culture is often defined as that It is used to describe organizational cultures in

which is shared—shared norms, values, beliefs, which there is widespread understanding and
and assumptions—which may serve to guide acceptance that “safety comes first” and in which a
behavior and action. We say may serve to guide majority of organizational members direct their
behavior and action in part because people can attention and actions toward improving it [5].
espouse values, beliefs, and assumptions but not Safety culture has been thought to be a subcompo-
act on them [41, 42]. Consequently, culture is not nent of organizational culture although there is
an infallible form of behavioral control even growing controversy as to whether safety culture
though it is often alleged as a primary cause of and organizational culture are indistinguishable.
myriad organizational accidents and catastrophes Experts recently have argued that safety cultures
(see [43]). Even the strongest culture cannot elim- do not exist separately from their organizations;
inate all untoward events, especially in techno- organizational culture influences safety ([40]:
logically complex and dynamic industries where 2–25). Moreover, some scholars propose that
things are not completely understood [9, 43]. safety culture, like organizational culture, should
If organizational members share behaviors, be normatively neutral and descriptive [43, 46].
beliefs, values, and assumptions, the assumption However, as it is currently defined and used in
is that they tend to adopt similar styles, modes of research and practice, safety culture itself is seen
conduct, and perceptions of how the organization as positive and “lead[ing] to increased safety by
does or should function. But studies show that fostering, with minimal surveillance, an efficient
cultures are not monolithic and can vary widely and reliable workforce sensitized to safety issues”
within a single organization. In fact, there is ([43]: 351). Yet, in doing so, it fails to encompass
extensive evidence that organization-wide inte- the complex relationship between an organiza-
gration, consensus, consistency, and clarity are tion’s culture and its safety performance ([46]: ix).
rare and that it is just as likely that cultures are The related concept of safety climate, defined
fragmented or differentiated ([42]: 537–538, [44]). broadly as organizational members’ socially
These differences are not necessarily bad. They shared perceptions of existing safety policies,
can be important and valuable organizational procedures, and practices, reflects the extent to
resources as they provide a diversity of perspec- which leaders, through their own behaviors and
tives and interpretations of emerging problems. through their organizational policies, value, pro-
Safety culture refers to the shared values, atti- mote, and reward safety relative to other compet-
tudes, and patterns of behavior regarding safety ing priorities [47]. It is generally agreed that
(i.e., concern about errors and patient harm that safety climate is an overt manifestation of safety
may result from the process of care delivery) [10].1 culture: specific, identifiable policies and proce-
dures that capture the surface features of culture.
The concept of safety culture was virtually absent from
1
In other words, safety culture is expressed
the academic and popular literatures until the 1980s through safety climate, which is why in this
(although a reference to safety climate first appeared in a
chapter we use the terms safety culture and safety
1951 study examining an association between psycho-
logical climate and accidents in the automotive industry climate interchangeably.
[45]). The concept of safety culture was given legitimacy Climate research is rooted primarily in a social
by the International Atomic Energy Agency (IAEA) in a psychological framework, whereas organiza-
1986 report on the Chernobyl accident. The US Nuclear
tional culture is rooted in anthropology. Climate
Regulatory Commission in a policy statement on nuclear
plant operations referenced the idea of safety culture researchers generally use more quantitative
again 3 years later. In March 2011, the US Nuclear approaches such as surveys, while culture
Regulatory Commission approved a new “Safety Culture researchers use more qualitative techniques such
Policy Statement” in which the commission defined
as in-depth ethnography. Current approaches to
nuclear safety culture and articulated key traits of a posi-
tive safety culture. assessing safety culture in hospitals and other
health care organizations using questionnaires highlights the fact that culture can be a source of
(e.g., surveys) are more appropriately thought of blind spots [52].
as assessing safety climate [48]. Questionnaire Culture is acquired through social learning
approaches are “only capable of sensing tran- and socialization processes; it is learned over
sient, surface features discerned from the work- time as groups solve problems. Strong cultures
forces’ attitudes to safety at a given point in are also a function of the stability of a group as
time—a snapshot of the prevailing safety cul- well as the length of time that it has existed. From
ture” ([49]: 657). Although safety climate data a vast array of safety culture studies we know that
typically are collected at the individual level, effective cultures are enabled by organizational
some experts claim that climate is only meaning- leaders through their actions and the manage-
fully assessed at the subunit/group level or the ment systems they create, are enacted by organi-
organizational level as these levels reflect the zational members when they put the organization’s
effects supervisors/leaders have on safety [50]. safety policies and procedures into practice, and
are continually shaped and elaborated over time
[5]. Specifically, cumulative research findings
ow Does Culture Control
H suggest that safety cultures are promoted by four
and Develop? factors that we consider below.
First and foremost, safety is thought to be a
If we think about culture as the “frames of refer- function of management actions, particularly the
ence for meaning and action, which encompass commitment to safety demonstrated by senior
the skills, beliefs, basic assumptions, norms, cus- management (top leaders as well as direct super-
toms and language that members of a group visors). This commitment is expressed in the
develop over time” ([40]: 79), we have a better goals leaders set, where they focus their atten-
idea of the mechanisms through which culture tion, and other communications and information
controls and unobtrusively guides behavior. Recall that signal what is and is not important, and how
our earlier description of Perrow’s [26] notion of organizational members should act and interpret
third-order control—control of decision premises. events. Management commitment to safety is
The presumed mechanism is a kind of motiva- also expressed in other management actions such
tional component that relates to expectations about as resource allocations, technology (including
the consequences of particular behaviors (e.g., personal protective equipment availability), train-
such as risk taking, procedure violation, or unsafe ing expenditures, systemic policies and proce-
behaviors such as not washing one’s hands, or not dures (e.g., care pathways), and information and
reporting errors). First-order controls such as reporting system design. Notice that these latter
direct supervision, inspection, or surveillance and behaviors are aimed at creating a more or less
second-order controls such as standard operating comprehensive safety management system,
procedures are conventional means to directly which is a broad dimension that fuels culture.
control behavior. Control through culture, although Second, safety culture is thought to be a function
hard to achieve, is necessary in complex decentral- of widespread shared attention to and concern for
ized systems and organizations, and especially possible hazards and their impacts upon people
when work is nonroutine, less analyzable, and (including work pressure hazards such as lack of
uncertain, as it is for many professional disci- staffing and time to complete tasks) and wide-
plines, such as health care. In organizations with spread information about how these hazards are
strong safety cultures, there is “tight social cou- being handled. Third, safety culture is a function
pling around a handful of core cultural values, and of realistic and flexible norms and rules about
looser coupling around the means by which these handling hazards. And, fourth, culture is enabled
values are realized” [22]. In this way, culture is a through continual reflection upon practice
way of seeing and acting that is simultaneously a through monitoring, analysis, and feedback sys-
way of not seeing and not acting ([51]: 284), which tems, and continuous process improvements.
154 K.M. Sutcliffe
A close examination of the above elements culture, good measurement is critical. The second
might suggest that enabling a safety culture is a is that there is considerable thematic overlap
top-down process, but this ignores the criticality between the instruments used to measure safety cli-
of diffuse, ongoing organizational discourse and mate in health care and instruments used in other
communication regarding the way “safety is han- industries. In other words, the core dimensions
dled around here” ([52]: 188). Shaping safety cul- commonly assessed in health care are consistent
ture is as much a bottom-up process as it is top with how safety culture is studied and assessed in
down. It flows from employee sensemaking of the other industries (and are similar to the dimensions
overall pattern of signals sent by organizational that we discussed earlier). Finally, with just a cou-
leaders as well as their sensemaking of the organi- ple of exceptions (see [55, 56]), few studies have
zation’s operating system (e.g., technology, prac- examined the relationship between work unit safety
tices, sets of rules and policies) to fathom the climate and patient outcomes such as rates of
hidden underlying core values and assumptions adverse events. Still Flin et al.’s analysis provides
that constitute the organization’s culture [53]. As growing evidence of significant associations
employees make sense of discrepancies between between safety climate scores in health care and
espoused and enacted priorities (e.g., differences workers’ safety behaviors (again consistent with
in declared organizational policy and informal studies in industries outside of health care).
supervisory practice), they discern the collective DiCuccio [57] more recently reviewed 17 stud-
unconscious values, beliefs, and assumptions ies exploring associations between safety culture
[41]. The ongoing process of the social verifica- and “nurse-sensitive” patient outcomes (p. 135)
tion of culture shapes role behavior considered (e.g., assessments of patient/family satisfaction or
appropriate and subsequently enacted [53]. Safety assessments of direct patient safety outcomes such
culture then, as we noted earlier, is a dynamic pro- as falls, medication errors, mortality). The findings
cess that is continually supported and shaped, show that progress is being made in terms of mea-
which makes it hard to control. surement and method—both are becoming more
rigorous and systematic. However, studies linking
culture and outcomes still are sparse and there is a
afety Culture and Outcomes: Some
S dearth of evidence supporting statistically signifi-
Evidence cant associations between safety culture and out-
comes. This suggests, all in all, that the state of
We noted earlier that empirical evidence linking safety culture research in health care is in its
organizational attributes and safety outcomes has nascent stages and there is much work to be done.
begun to accumulate, although outcome studies Still research outside of health care suggests that
are relatively uncommon. The same is true for safety culture matters. This state of affairs may
research linking safety culture with safety out- signal that researchers might want to focus their
comes (e.g., patient and organizational outcomes, efforts on developing and testing middle-range
and employee behaviors). Although evidence is theories—that is to develop and test models that
sparse, some exists and below we highlight two aim to better understand the underlying more
reviews of recent findings. proximal mechanisms rather than distal outcomes.
Flin and colleagues [54] reviewed 12 health Given the complexity of health care systems, that
care studies to better understand the dimensions may be where the purchase is.
assessed by safety climate surveys in health care
and their psychometric properties. Three findings
stand out. The first is that researchers have paid Implications
rather limited attention to the psychometric proper-
ties of safety climate measures (e.g., validity and Safety in health care is both elusive and challeng-
reliability). If health care managers are to rely on ing. Safety demands seeing what is not there, an
these indicators as a valid assessment of their safety accident in the making [58]. It is an “ever-
receding chimera, observable only when it ceases Conclusion

to exist” ([43]: 395). This makes it difficult to
manage because people often don’t know how In this chapter we have explored organizing and
many mistakes they could have made but didn’t, culture as two means to attack the safety prob-
which means that they have at best only a crude lem. We have tried to show that although some
idea of what produces safety and how safe they consider these to be all-purpose solutions, they
are. Safe outcomes are also constant, which are not infallible. Thus it is critical to understand
means that there is nothing to pay attention to that you don’t get safety behind you. Still, orga-
[11]. This complicates learning because system nizations, their units, and their members that
safety feedback is often discontinuous and indi- organize in particular ways repeatedly and con-
rect. It is discontinuous because recorded acci- tinually are likely to achieve greater safety and
dents, incidents, and even near misses are reliability than those organizations that don’t, in
relatively rare events and indirect because these part because of the binding safety cultures that
data only reflect a system at a moment in time they create through the enactment of these pro-
rather than necessarily indicating its intrinsic cesses and associated activities. If we take seri-
resistance to operational hazards [59]. As a result, ously the idea that the only realistic goal of safety
safe performance relies on making the unthink- management in complex health care systems is to
able cognizable, the invisible apparent such that develop an intrinsic resistance to its operational
accidents in the making can be more readily hazards, our perspective provides insight into
detected, and producing a “dynamic nonevent” how to foster this intrinsic resistance. Studies
through patterns of practice that shape percep- showing the efficacy of organizing and culture
tions, conceptions, and understanding that permit for medicine and health care are in their nascent
contingent responding. stages, but evidence is building to suggest that
Practically speaking, in health care, just as it is these ideas are worth paying attention to.
the case in just about all organizations, service
and production goals may compete or may be
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The Role of Architecture
and Physical Environment 12
in Hospital Safety Design
Charles D. Cadenhead, Laurie Tranchina Waggener,
and Bhargav Goswami
“Architectural space, however large or small, joins and then bends attention to new
thoughts.”
—Ann Cline, Architect
starting during the Age of Enlightenment. But

Introduction what we think of as modern surgery has largely
been made possible by two significant mid-nine-
Surgical programs vary greatly by size of hos- teenth-century discoveries. The first was alleviat-
pital and type of services provided. A small ing pain and the second was infection control.
rural hospital is very different from a very Without these advances the science of invasive
large, tertiary teaching hospital in an urban set- surgery could not have taken place. Much of the
ting. This chapter attempts to target the middle design of contemporary surgical facilities is
ground—not the rural hospital, and not the about these two topics.
largest hospital. Elements of both are very Pain control, now thought of as anesthesia,
interesting and provide learning opportunities began to change the face of surgery in the 1840s
for each other; however, including the full with the discovery of chemicals such as ether and
range of programs with all subtle differences chloroform. Until this time, surgeries were lim-
would warrant a book unto itself. ited to quick procedures causing terrific pain to
the patient. Indeed, the shock of the procedure
and loss of blood could do more harm than the
Little History and Modern-Day
A act itself. These new chemicals allowed opera-
Statistics (Figs. 12.1 and 12.2) tions to be longer and more invasive, and there-
fore educating the surgeon further in the use of
Surgery, as a topic of healing, is found in ancient surgery to cure certain maladies.
illustrative images and texts from China, India, Some 20 years later, Joseph Lister, a British
and Greece. Early Europe contributed to the field surgeon following research done by the French
chemist Louis Pasteur, found that by cleaning his
instruments with carbolic acid he could reduce
C.D. Cadenhead, FAIA, FACHA, FCCM, B. Arch. (*)
L.T. Waggener, BSRC, RRT, BID, CHID, IIDA, EDAC the incidence of gangrene. Following this, he fur-
B. Goswami, M. Arch., B. Arch. ther realized the importance of using sterilized
WHR Architects, 1111 Louisiana St., Floor. 26, instruments, leading to the use of sterile
Houston, TX 77002, USA instruments and materials in operating theaters.
e-mail: [email protected];
[email protected]; BGoswami@ He introduced the steam sterilizer, and enforced
whrarchitects.com handwashing and, ultimately, the wearing of

160 C.D. Cadenhead et al.
Fig. 12.1 The Old Operating Theatre, London, UK (Photograph by Mike Peel)
Fig. 12.2 New Hybrid Operating Room, Rome, Italy
gloves during surgery. This, combined with anes- procedures performed in US hospitals. The 2011
thesia, made possible the modern surgical pro- average hospital cost for all stays was $10,600
grams we know today. per stay; the average hospital cost for a surgical
In 2012, there were 36.5 million hospital stay was $21,400, about twice that of the overall
stays in the USA. Of these, about 22 % were sur- average. Surgery is an expensive service to pro-
gical stays, or approximately eight million. In vide and requires a disproportionate amount of a
2011, there were over 15 million operating room hospital’s budget. It also has the potential to be
12 The Role of Architecture and Physical Environment in Hospital Safety Design 161
the greatest revenue and profit generator of all northeast and two are located in the south. These
service lines. For this reason, if no other, doing it hospitals vary in when they were built and how
well, doing it safely, is very important to those they have expanded over the years. This compari-
that provide the skills and manage the service. son highlights regional responses to programs and
how programs evolve over time.
With adequate data in planning a new surgical
The Surgical Suite suite, the purpose of comparing numerous similar
surgical programs is to evaluate the overall size of
Program Building Blocks the department and the distribution of spaces
within it against programs offering similar ser-
All surgical suites are made up of the same basic vices. It is a quick way to identify areas that should
programmatic areas. They vary in design approach, be further assessed. In such an exercise, one may
hospital attitude toward space, cost, square footage identify ORs that are smaller than expected, or cir-
allocation, and regulatory interpretation. culation that is inadequate in contemporary surgi-
cal suite planning. These comparisons, when
1. Public areas (waiting, reception/business,
conducted in early planning, illuminate areas war-
family amenities) ranting further discussion or might serve as a final
2. Preoperative area cross-check, validating that all process flow issues
3. Operating and procedure rooms have been addressed sufficiently.
4. Postanesthesia care unit (sometimes referred
to as the PACU or recovery room)
5. Phase 2 recovery area urgical Suite Organization
S
6. Staff support areas (Fig. 12.3) and Design
For preliminary planning, Fig. 12.4 suggests As with complex puzzles, there are numerous
what might be expected in departmental gross organizational plan layouts used in surgical suite
square feet (DGSF) per operating room (OR) for design. Within bounds, there is no wrong or right
different types of hospitals or outpatient surgical plan. Architects and medical planners have pref-
centers. These DGSF figures include all the erences in what they do, as do surgeons and staff
rooms that make up the seven programmatic in their own work. For programs of differing
areas listed above, plus the circulation required to sizes, characteristics, and regional locations, we
connect these areas. Design approach, which will have successfully designed surgical suites using
be discussed further, also affects DGSF/OR. Not virtually all possible configurations. One layout
included in the DGSF area are elevators, stairs, does not fit all, and the designer should take care
outside walls, or engineering systems. not to impose a predisposition on every new cli-
In general, these facility categories differ in ent. Building consensus with multiple users of
expected surgical case acuity and specialties, the surgical suite is very important (physicians,
equipment technology needs, staff numbers, nurses, techs, administration, facility manage-
teaching programs, and, possibly, research activi- ment, and others) [1]. We have found that fre-
ties. Competition between hospitals for physi- quent communications with all involved, and
cians and patients can impact square footage in early participation in option exploration, is criti-
the form of spacious, hospitable lobbies, and cal to completing design with a hospital team that
family-centered amenities. endorses and supports the project. Planning work
Comparing four US hospital surgical depart- sessions, something we call “gaming” (Fig. 12.6),
ments in greater detail, Fig. 12.5 describes the can bring all stakeholders to the table. This
total square footage, distribution of spaces by the method uses nontechnical, non-drawing methods
seven program areas, surgical procedure num- to encourage all to participate in the creation of
bers, and design layout. Two are located in the their future workplace.
Fig. 12.3 Surgical program blocks (courtesy of WHR architects)
Fig. 12.4 Departmental gross square feet per operating room for total departmental size calculation (courtesy of WHR
architects)
Fig. 12.5 Allocation of square footage by function within department (courtesy of WHR architects)
Fig. 12.6 Gaming work session (courtesy of WHR architects)

Suite Layouts moving clean materials to the ORs and return-

ing soiled materials after cases are complete.
There are three conventional suite layouts. Each Preoperative and PACU spaces may be located
has been used, with various changes and combi- to facilitate entering patients presurgery, and
nations over the decades, most with a high degree departing patients postsurgery.
of success. 3. Third, referred to as a sterile core design, or
racetrack, arranges ORs in a loop around a
1. First, and perhaps the one that has been in use sterile supply room. In this manner, sterile
the longest, is called a traditional layout, or a supplies can move directly into the OR as the
double-loaded corridor plan. This is similar, next case is being set up [2]. This reduces the
in concept, to a hotel corridor with doors on movement of sterile carts in congested corri-
both sides (hence “double-loaded”). While dors. In large suites, either the sterile core
currently not seen so often in the USA, this becomes very long or it is broken into several
shape and layout are currently used in Europe sterile cores with fewer ORs around it.
where daylighting regulations require all
rooms where people work to have direct
access to daylight. The wings in European New Layouts and Flow
hospitals are narrow, as compared to the large
treatment blocks seen in the USA, to allow for A somewhat new surgical suite layout has
this daylighting. This does mean that surgical evolved out of healthcare’s interest in “lean
suites can become long, requiring greater process.” Simply described, the patient’s move-
travel distances. ment is one-way, or linear. They do not return to
2. Second, referred to as a pod design, groups a space previously used. In theory, this is to
ORs by specialty. Supporting spaces, such as increase efficiency and throughput, and enhance
sterile supply, may be to the rear of the suite, the patient experience (Fig. 12.7).
Fig. 12.7 Plan of a lean surgical suite (courtesy of WHR architects)

Another change in this plan type is the inclu-

sion of staging rooms. Located outside of each
OR, this allows scrubbed technicians and nurses
to set up tables for the next case while the previ-
ous case continues [3]. This is thought to reduce
room turnover time and improve throughput (see
A, Fig. 12.7). Flow station rooms are also added
outside of each OR as a place for surgeons to do
postoperative documentation and prepare for the
next case (see B, Fig. 12.7). There are still points
of traffic crossings and walking distances may
not actually be shorter than in other layouts.
Suite Layout Characteristics
Surgical suite layout characteristics, or attributes,

generally fall into the following categories. Each
layout organization has advantages and disadvan-
tages, and no layout will be perfect.
1. Flows and circulation (patients, staff, materi-

als; mixed, segregated)
2. Access (by user) and travel distances (sensible
access and connection; short distances from Fig. 12.8 Surgery reception and waiting lounge, Houston
origin to destination) Methodist Hospital, Houston, TX (courtesy of WHR
3. Specialty grouping vs. standardized rooms
architects)
(centralizing alike rooms; standardizing as
many rooms as possible)
4. Flexibility and growth (accommodation for
and is pleasing to the eye, the patient will begin
change; preplanned ability to expand) their personal experience with a better impres-
sion and higher expectation [4]. The same is true
for staff. The environment delivers a message [5]
Public Areas (Fig. 12.8).
Public areas serve many different populations—

the arriving patient and accompanying friend or Preoperative Areas
family member, the hospital staff receiving the
patient, hospital business staff related to financial For those working in hospitals and surgical pro-
and consent matters, seating for those waiting, grams, it is easy to forget how anxious and con-
and amenities ranging from consultation rooms, cerned the patient and family can be. They do
toilets, nourishments, educational resources, and not know what to expect and their image of what
access to computers or workspaces. they are going to experience may be based on
It should be noted that initial impressions popular television shows or movies. If they are
affect the opinion of safety and quality expecta- the patient, they may be whisked off, stripped of
tions of everyone. If the built environment is well their clothes and belongings, poked and exam-
organized, appears clean and well maintained, ined, asked questions by multiple people they
Fig. 12.9 Partial plan of a pre-op suite, Houston Methodist Hospital, Houston, TX (courtesy of WHR architects)
have never seen before, and medicated. If they standing in uncomfortable surgical garb under
are unlucky, all this happens in front of other lights, doing precise work. More frequently now,
unfortunate patients encountering this same they may be sharing the room with a robot and/
experience. or colleagues of different specialties in hybrid
To a large degree, the hospital’s culture and operating rooms. They can rearrange the room,
attitude toward design can mitigate the effect control the intensity and color of lighting, and
of these experiences. Being guided through the speak real time to fellow surgeons or a medical
preoperative path by a caring and empathetic class across the corridor or across the globe.
individual is reassuring. The built environment Pathology reports and images are called up for
can also improve this experience. Private pre- integrated display on large, crystal-clear screens
operative rooms have shown to provide pri- around the room.
vacy, better communications, and comfortable
space for family, providing the patient with
dignity at a time when they are feeling vulner- Operating Room Size
able [6] (Fig. 12.9).
Not very many years ago, operating rooms were
considered large if they exceeded 400 ft2. In recent
Operating Rooms years the size of ORs, while always a point of
much debate in design sessions, has appeared to
To the surgeon and certain members of the OR stabilize with more rational discussion around the
staff, this is the center of the world. The experi- equipment and staff numbers to be accommodated
ence of the provider and the impact on the patient [3]. Today, general ORs range around 550 SF to
are highly influenced by the environment and the 650 SF, while hybrid ORs, containing multiple
human factors under which they perform [7, 8]. fixed equipment setups, may be as large as 1000
It is where they spend long hours, and endure SF [9] (Fig. 12.10).
Fig. 12.10 OR sizes by specialty, based on Advisory Board findings
Fig. 12.11 Houston Methodist

Hospital, OPC OR desk (photograph
courtesy of WHR architects)
Communications in the OR included here. The Methodist desk (Fig. 12.11)

is designed in a curved shape and is same handed
In addition to integrated information system dis- in all ORs within this suite. The second
play, the value of improved communications in (Fig. 12.12) is a tee-shaped desk adapted into a
generating better situational awareness and large OR. The shape allows the occupant to
coordination among OR staff has been identi- slide in and out easily. Designs for two staff
fied [10]. We have designed several approaches members that encourage communication, meet-
to accommodate documentation staff workspace ing, and computer access during surgery [11]
during cases and have seen other designs while create environments that create more collabora-
touring OR suites around the country. Two are tion and trusting settings.
Fig. 12.12 OR desk (courtesy of WHR

architects)
Fig. 12.13 Advantages of universal OR design (WHR architects)
Universal ORs If planned during design, the steps needed for

smart flexibility serve are reasonable anticipation
The increase of OR sizes and rapid changes in sur- of the future. Figure 12.14 illustrates preplanning
gery have led to the concept of developing the uni- the conversion of ORs into interventional imag-
versal OR, one that can accommodate multiple ing rooms, connecting to surrounding ORs. This
equipment arrangements and meet the needs of mul- speeds up the future conversion and reduces cost.
tiple case types. The cost and disruption of renovat-
ing ORs are very expensive. To some, the incremental
initial cost is well worth the while (Fig. 12.13). Postanesthesia Care Unit
This is the critical care unit of surgery. In fact, many

Planning for Change critical care units were originally surgery recovery
rooms. Currently, most recovery rooms continue to
For many of the reasons that universal ORs are of be open bay spaces with curtains providing separa-
interest, preplanning for OR change is beneficial. tion between patients. Primarily this space is the
Fig. 12.14 OR planning for future change (WHR architects)
domain of the anesthesiology care team bringing

the patient out of anesthesia after surgery. Once the
patient is stable, the patient is moved to their hospi-
tal room or to stage 2 recovery until they are ready
to be discharged home.
In large surgical programs, with adequate
numbers of specialty surgery patients,
postsurgical patients may be moved directly from
the OR to a critical care unit for recovery. In
some cases, these are specialty critical units
matching the patient’s type of surgery, e.g., a car-
diovascular or neurosurgical ICU [12]. In this
situation, it is not infrequent that the patient is
cared for in a private ICU room (Fig. 12.15).
Phase 2 Recovery
Most hospital surgical suites perform both inpa-

tient and outpatient surgery. When outpatient sur-
gery is included, a Phase 2 recovery room is
Fig. 12.15 An ICU recovery position (photograph cour-
required. This area is to be connected to the tesy of WHR architects)
PACU, but must be a separately identified area.
The hospital has the choice of using open bays,
cubicles, or private rooms for this use. If the hos- patient and room for a family member to join
pital uses private rooms for preoperative patients, them. The private room brings the same benefits
it is possible to use these same rooms for Phase 2 as described under the preoperative area discus-
recovery. This allows privacy for the recovering sion above.
Fig. 12.16 A Surgical Staff

Lounge, Houston Methodist
Hospital, Houston, TX
(courtesy of WHR architects)
Physician and Staff Support Areas

he Details: Design Thinking,
T
Support space for surgical staff is very differ- Processes
ent, and much improved over the years regard-
ing provisions for quality downtime and access nderstanding the Needs
U
to nature. Creating environments to support this of the Patient
highly skilled group is recognized as important
to staff wellness and improved operations Listening to the voice of the customer, the patient,
(Fig. 12.16). The staff lounge in the photograph today’s hospital administrators, front-line practi-
illustrates many decisions initially not obvious. tioners, and healthcare interior designers learn
It suggests a series of decisions made by hospi- what patients expect in their hospitalization.
tal administration to locate this lounge on an Survey reports reveal that patients need to be
outside window wall with great views to the heard, to rest, to have access to their health infor-
surrounding medical center and natural light, mation, and, understandably, to be discharged
both providing positive distractions and respite without hospital-acquired conditions [13]. Publicly
from the OR. In addition to a delightful envi- available data reveals how patients perceive not
ronment, nourishment is provided and comfort- only the physical environment but also the provid-
able furniture is available for relaxation. ers who work in the healthcare environment based
Adjacent to this lounge, located only steps from on the physical surroundings and the demeanor of
the OR, are education spaces used by all surgi- the front-line practitioner [13]. Never events, a
cal staff, physicians, and fellows. term introduced in 2001 by Ken Kizer, MD, for-
Workspace for surgical staff is another mer CEO of the National Quality Forum (NQF),
opportunity to create positive places for peo- referred to preventable harm episodes such as
ple. The following image illustrates a work wrong-site surgery as episodes which should never
environment located so that those needing occur [14]. This term was introduced in response
quiet, hence the glass, can still have visual to the groundbreaking IOM report, To Err is
access to an outdoor rooftop garden. At first Human [15]. Sixteen years after this report,
glance, you wouldn’t realize that this garden is patients continue to experience preventable harm
located four levels above ground (Fig. 12.17). and often struggle to have their voice heard, and
Fig. 12.17 Entry to administrative

services (photograph courtesy of
WHR architects)
costs continue to rise. Early communication Understanding the systems approach to planning
between hospital leadership and the design team for a safe workspace is essential to fully under-
regarding mission, vision, and goals and process standing the operational as well as the environ-
improvement solutions will empower the architect mental causal factors to adverse events [17].
to plan for the safest and most reliable environ- According to Carayon et al. [18], most errors in
ment [16]. Additionally, early communication is patient care arise not from the solitary actions of
essential for the general contractor to develop a individuals but from conflicting systems in
construction budget with any accuracy, and is cru- which multiple people interact. The built envi-
cial for goals and evidence-based design solutions ronment creates the setting and physical envi-
to be realized in the built environment. ronment to support safer, reliable, and
exceptional service [19]. A poorly designed peri-
operative service-line environment can compli-
nderstanding the Needs
U cate workflow and introduce inefficiencies
of the Perioperative team creating patient harm and dissatisfaction [19,
20]. Application of design thinking in the pre-
Healthcare architects and interior designers must design phase offers the opportunity for innova-
also listen and understand with great depth the tive strategies in addressing safety, efficiency,
voice of the other customer: the multidisci- and value [21].
plinary team of perioperative services.
Architecture firms that are the best equipped to
apply evidence-based design strategies will need Lean Design
the perioperative service-line goals embraced by
the organization. Consequently, the time to Pre-design operational improvement using the
review and revise operational information, Lean Six Sigma process improvement techniques
patient throughput, and workflow strategies can significantly change design requirements for
should be discussed in process improvement dis- spaces and square footage in key departmental
cussions rather than in the design phases of the areas [22, 23]. Engagement in such techniques
physical environment according to the often results in a reduction in square footage which
Commonwealth Fund 2013 publication [17]. results in added value. When reviewing patient
Fig. 12.18 PSH-proposed preoperative goals and recommended design elements
flow from the patient experience perspective, there 2. Patient experience—satisfaction with and
is an opportunity to identify potential bottlenecks positive perception of privacy, noise, commu-
in the patient flow and the identification of break- nication, environmental cleanliness, service,
downs or barriers in the continuum of care. Design and personal safety
optimally will then follow process improvement 3. Human performance—prevention of human
strategies [24]. error through knowledge and specification of
furnishings and surface finishes which support
ergonomics and human factors, facilitating a
Working Definitions level of cognitive and technical performance,
robust communication, and teamwork
For the purpose of addressing patient safety,
patient experience, and human performance, this Using the proposed, patient-centric periopera-
section uses the following working definitions: tive surgical home (PSH) phases as a framework
for design considerations [25], this section will
1. Patient safety—reduction of environmental propose environmental attributes relative to facil-
elements correlated with falls, infection trans- itating service-line issues articulated in the litera-
mission, and medication errors ture [25, 26]. See Figs. 12.18, 12.19, and 12.20.
Fig. 12.19 PSH intraoperative goals and recommended design elements
and facilitating the patient’s readiness for dis-

reoperative Phase: Opportunity
P charge and management for their needs at home
for Enhanced Communication or another level of care facility [27, 28]. This
phase of perioperative services has historically
Admission department processes provide opti- been associated with long wait time and time-
mal time and location for care providers to obtain fragmented admitting processes. In 2003 the
critical information regarding the patient’s cur- Institute for Healthcare Improvement (IHI)
rent medications, language barriers, level of edu- emphasized the need to improve patient flow and
cation, and any functional activity limitations at patient access processes to include smoothing of
home. This important information facilitates the flow of patients in and out of institutions,
clear communication of the patient’s needs which would help to reduce wide fluctuations in
throughout the care continuum and in planning occupancy rates and prevent surges in patient
Fig. 12.20 PSH postoperative goals and recommended design elements
visits that lead to overcrowding, poor handoffs, perioperative patient journey [27]. Responding
and delays in care, thus contributing to safety to these recommended process improvement
and quality of care [29]. Improved communica- strategies has significant implications in plan-
tion at this point in the patient journey has the ning and design of this important front door for
potential for enhanced medical record accuracy patients and families, in particular the unplanned
and continuity of communication throughout the admission.
ultiple Points of Entry: Designing

M I nterior Architecture and Design
for Safety, Efficiency, and Comfort Considerations
Large academic medical centers often struggle Surface performance characteristics during pre-
with managing the multiple ways patients arrive operative phase include the following:
for preoperative services. Given the multiple care
pathways in which patients may enter a hospital,
opportunities to standardize and streamline docu- Patient Safety
mentation, communication, and handoffs can be
accomplished in tandem with new staffing prac- 1. Hard surface flooring—surface texture and
tices in this area. Crucial conversations regarding door thresholds should offer resistance against
integration with robust information technology slips, trips, and falls. Surface gloss finish should
services before expansion renovation and new provide minimal glare and reflectivity from
construction are vital. ceiling-mounted ambient light sources [30].
Multiple points at which patients and families 2. Soft surface flooring—surface density and

can be more engaged for more robust communi- pile height should facilitate use of mobile
cation and documentation preoperatively devices while offering postural stability for
include: elderly gait patterns [31].
3. Lighting—points of medication prep and
1 . Direct admit—unplanned from doctor’s office administration should include task lighting per
2. Admit from the ED—unplanned recommendations of the Human Factors and
3. Admit for elective surgery—planned Ergonomic Society of North America in addi-
4.
Same-day admit for elective tion to design options reducing interruptions of
surgery—planned practitioners during critical processes [32].
5. Admit via ambulance, patient on gurney from 4. High-touch surfaces—should be chemically
another facility—planned and unplanned compatible with facility disinfection and com-
port to the CDC protocols of surface cleaning
Facility design considerations worth noting of high-touch, environmental surfaces [33].
for embedding patient safety at entry points noted 5.
Handwashing sinks—should be located
above include the following: within the sightlines of front-line practitioners
as well as patients and families in waiting
1. What number of offices for enhanced, engag- areas. Additional hand-sanitizing options
ing, and private communication for patients should be offered in waiting areas.
scheduled for elective procedures 6. Furniture—specification of chairs with arms
2. Size and quantity of private spaces and/or
should be considered to facilitate a safe stand-
offices required to accommodate the slower to-sit and safe sit-to-stand access to furniture.
process times for infirmed and elderly while
providing space for engaging patient advo-
cates such as adult children Patient Experience
3. Means for safe boarding of patient arrivals on
gurneys via ambulance (from nursing homes) 1. Flooring—should offer visual and physical

4. Waiting accommodations of the contagious
comfort associated with a welcoming and car-
and noncontagious patients in addition to the ing environment. Soft surface flooring offer-
cycle time associated with the assessment of ing noise-reducing attributes should be highly
the unplanned admission considered in places of patient and family
5. Planning considerations for robust IT for con- waiting.
tinuity of patient information throughout con- 2. Ceilings—noise reduction coefficient should
tinuum of care be ≥0.80 to reduce ambient noise associated
with multiple conversations within waiting pportunities for Efficiency, Patient

O
areas finished with hard surface flooring [34]. Safety, and Patient Experience
3. Walls—should be strategically placed to pro- in Pre-op, Prep/Hold
vide privacy at multiple points of periopera-
tive surgical patient arrival. The pre-op, prep/holding area becomes an
4. Furniture—room configuration for private
adjunct access point, providing an opportunity to
spaces should facilitate furniture layouts that identify any items missed during the admission
enhance eye-to-eye contact between patient process. Anecdotal patient and family feedback
and practitioner [35]. expressed to healthcare administrators reveals
5. Positive distractions should provide stress-
that lack of acoustical privacy coupled with dis-
reducing attributes within waiting areas [36]. cussion of hospital costs, signing of consent
6. Navigation—architectural elements, use of
forms, and exchange of other personal informa-
color, art, or sculpture should provide memo- tion is correlated with patient dissatisfaction and
rable impressions to facilitate ease in naviga- best conducted before this point of care.
tion to destination points throughout the Understanding the operations of these depart-
continuum. Areas of rest including benches ments guides the hospital planner in addressing
with arms are encouraged as respite places for patient concerns as well as the needs of the front-
the patients with dyspnea and other cardiovas- line practitioner in this department. Among the
cular impairments. most pressing:
1. Enhanced visibility of nurse to multiple

Interior Specifications to Facilitate patients
Optimal Human Performance 2. Acoustical privacy for patients and family
3. Spatial accommodations for family presence
1. Floors—should provide the optimal sound- 4. Acoustical design to enhance caregiver recog-

absorbing properties and matte surface gloss nition of alarms and speech recognition
to reduce ambient noise and glare associated 5. Access to supplies for anesthesia services and
with worker fatigue. nursing staff
2. Walls and/or private spaces—should be pro- 6. Appropriate lighting to facilitate patient
vided for enhanced communication, assess- calm and comfort while facilitating safe
ment, and comprehension for both patient and procedures
provider at multiple points of perioperative 7. Immediate access to handwashing sinks
surgical patient arrival.
3. Ceilings—noise reduction coefficient should Designing for high visibility while provid-
be ≥0.80 to reduce ambient noise including ing a calm, supportive, and private space for
loud alarms that lead to alarm fatigue for patients and families remains challenging for
enhanced speech recognition in addition to architectural designers. While one cannot
accuracy in simple and complex tasks [37]. refute the importance of high visibility and
4. Indirect lighting—should be provided to patient safety, anecdotal reports reflect high

enhance accuracy of screen-based tasks. patient satisfaction with private prep/hold
5. Low light reflectance value of surface color rooms with connecting toilet rooms.
and low gloss rating. Establishing a list of priorities in pre-design
6. Adjustable, ergonomic task lighting for paper- regarding operational process flow, safety, and
based tasks. experience will be valuable information to
7. Flooring surface texture which facilitates sur- share with the architectural planners and
face cleaning while reducing ambient glare. designers.
Intraoperative Phase It must be noted that many jurisdictions have

additional governing bodies which have final rul-
ing over interior finishes and the assemblies of
interior finishes. The diagram (Fig. 12.21) illus-
The Details of Human Performance trates these entities. The building type, the num-
ber of people using the building, and how the
he Complex Workspace of Surgical
T building will be used in terms of activities will
and Anesthesia Service also determine products and the proper assembly
of products regarding fire and the health safety
An understanding of the relationship of environ- and welfare of individuals in the building.
mental factors on patient safety, well-being, and Additional regulatory agencies exist at the local
worker effectiveness is crucial [30, 31, 38]. The level in the jurisdiction of the project. Examples
interior designer current with the design research include local municipal ordinances, health codes,
literature should be able to apply the correlation and zoning regulations. Figure 12.1 illustrates the
of illumination levels, ambient noise levels, and examples of such agencies.
flooring surface characteristics relative to human Additionally, owners need to be informed that
fatigue and potential human error [31]. The the final governing publication regarding mini-
workspaces where invasive procedures occur are mal requirements might be the Facility Guidelines
challenging spaces for designers to influence Institute (FGI)’s Guidelines for Design and
human performance relative to high ambient Construction of Health Care Facilities. In a simi-
noise and prolonged time standing. The rigors of lar manner with other code research, one must
cleaning protocols, maintenance of air pressures, inquire regarding the latest adopted publication
required illumination levels, and code require- [34] in the jurisdiction. The latest edition was
ments render this environment quite harsh and published in 2014 with the next publication due
unforgiving as a place of work. Reengineering to be published in 2018 and will be available at
these spaces to accommodate the growing human www.fgiguidelines.org. The FGI guidelines are a
factor literature is key to creating optimal out- valuable reference for the perioperative team to
comes [39, 40]. In this highly regulated environ- review in preparation for renovation and new
ment, there are many protocols of which the construction projects.
architect and interior designer must adhere. The Patient safety/human error literature reveals
most widely used building code in the USA is the that current topics are complex and solutions pro-
International Building Code (IBC) [41]. viding positive outcomes are yet to be realized.
Root-cause investigations of wrong patient,
wrong site, and wrong procedure patient errors
(WSPE) consistently reveal communication and
coordination issues as prominent underlying fac-
tors [42, 43]. Adverse events such as unintended
retention of foreign body rank second to WSPE
according to the Joint Commission sentinel event
2014 report [44]. Kao et al. [45] note that crew
resource management training has positive
impacts on behavior and attitudes in anesthesia,
emergency medicine, and surgical services; how-
ever investigations regarding impact on outcomes
are lacking. Additionally, human factor analysis
provides another approach to learning more
Fig. 12.21 Authorities having jurisdiction over construc- about near misses and errors by examining activi-
tion projects ties in the surgical environment such as technical
and nontechnical demands, mental work load, trasts, which can cause eyestrain and problems
and interaction with the equipment, work envi- seeing clearly, are common in operating rooms
ronment, and team dynamics [46]. due to high illuminance levels from surgical
luminaires and low illuminance in surrounding
areas [51].
bserving for Errors and System
O Surgeons are consistently exposed to high
Factors illumination when focusing on the surgical cav-
ity. It is critical to increase the general lighting in
In an exploratory study using a systems approach, an operating room, especially around the operat-
[47], researchers conducted direct observation ing table, to decrease the luminance contrasts and
during cardiac surgery to identify teamwork prob- facilitate the operating personnel’s visual ability.
lems, equipment factors, extraneous distractions, Scrub nurses are exposed to various levels of illu-
training-related issues, and resource accessibility mination within brief moments as focus shifts
and the association with surgical flow disruption. from the surgical cavity to the nearby instrument
This study observed that operative errors that table. Shifting from high illuminance levels to
occur during cardiac surgery are associated with lower requires an adaptation response which
surgical flow disruptions, specific to teamwork- causes larger cognitive loads and impacts pro-
related disruptions. Moorthy et al. [48] demon- ductivity. The anesthesia services focus on moni-
strated, using motion analysis, that operating tors and can best be served with lower level of
room stress in the form of a competing task, noise, general room illumination. Research identifying
or need for speed all resulted in decreased dexter- the optimum lighting levels from the operating
ity and increased errors. Studies following team table to surrounding areas is needed. Hemphälä
performance after training in simulated environ- demonstrated that surgical caregivers performed
ments report enhanced teamwork but further best when surgical light illuminance and general
research is indicted to correlate this training with lighting illuminance contrasts were minimized
outcomes. Design opportunities to contribute to and when surgical lamps were not on their high-
safe workspace practices during surgery are the est possible setting [52, 53]. Lighting design for
use of floor patterns and change of color material enhanced productivity of all job descriptions
to clearly delineate the functional zones with the needs to be a top priority for insuring productiv-
OR [19]. Defining policy and service research ity in the operating room. To circumvent indirect
outcomes more clearly around the functional glare associated with high illuminance and highly
zones relative to the anesthesia workspace, the reflective surfaces, it is recommended the perim-
perfusion workspace, the sterile field, and the cir- eter walls are painted in a pigment which contrib-
culating field, perhaps nondisruptive workflow utes to a low luminance, such as a 40–60 % light
pathways are needed if we are to make the design reflective value (LRV) [54].
of these spaces more evidence driven [49].
Human Needs
Lighting and Performance
Front-line practitioners require convenient access
Insufficient illumination that increases the risk to water during the course of their shift and the
for eyestrain, musculoskeletal discomfort, and perioperative team is no exception. Research find-
headaches and can negatively affect the individu- ings indicate that dehydration negatively impacts
al’s work performance [50] is another recognized cognition, energy levels, and memory recall in
concern in areas of fine and complex tasks. young adults [55]. Hydration stations are impor-
Surgery is visually demanding and requires a tant considerations in healthcare design and
good visual environment with efficient illumi- should be adjacent to other key support spaces
nance and minimal glare. High luminance con- located within the process flow of staff [24].
Interior Architecture and Design the most appropriate workspace design for this
high-risk environment.
Surface performance characteristics for optimal
human performance in surgery include the
following: Postoperative Phase
1. Floors—should provide the reduction in noise Design research literature is rich with publica-
secondary to impact and footfalls. tions correlating elements in the built environ-
2. Floors—surface gloss should have a matte
ment enhanced recovery, pain tolerance, and
gloss rating to reduce glare associated with sleep quality necessary to avoid readmission.
worker fatigue [54]. The literature reveals that views to nature and
3. Floors—surface visual texture should be min- access to daylight have positive outcomes on
imal, void of aggregates that would hinder the patients and well as the front-line practitioner
identification and retrieval of objects on the [56, 57]. Most importantly the built environ-
floor. ment, including the PACU, ICU, and acute care
4. Flooring surface texture which facilitates sur- patient room in particular, should be planned and
face cleaning while reducing slip and fall. finished with materials that support prompt
5. Walls—surface color should have a light
ambulation, physical therapy, nutrition counsel-
reflectance value of between 40 and 60 % to ing, and visits with social workers. Many institu-
reduce the percentage of reflected incident tions bring all the services to the patient rather
light into the eyes [50]. than transporting patients to the services.
6. Surfaces—should be selected to achieve the Designing rooms that look to nature vs. walls
recommended range for sound in operating can reduce nursing stress levels and improve
rooms (40–50 dBA) [34]. patient services [58].
7. Ceilings—where code permits, gasketed ceil- Flooring surface texture specification not only
ing tiles with an NRC ≥0.80 should be speci- should address ease of surface cleaning but also
fied to reduce ambient noise for enhanced can serve as an element that contributes to safe
speech recognition and intelligibility. ambulation. Other environmental factors include
8. Lighting—reduction in illumination contrast proper illumination from electrical light sources,
between surgical field and circulating field. surface gloss, and elements to support ambula-
tion, such as handrails. There is a paucity of evi-
While there is a great need to improve the evidence regarding design features that minimize
dence around the human factors that contribute to patient falls, in addition to inconsistency in
safe and reliable surgical team performance, reporting findings, diversity of research methods,
knowledge of the current issues should stimulate small sample sizes, and numerous confounding
design thinking to address these potential corre- factors [6, 30, 31]. It is important to note that
lations [20]. There are multiple implications lighting not only supports safe ambulation but
regarding the built environment’s impact on also is necessary to reduce human error during
enhanced sound attenuation for adequate speech medication administration.
recognition, communication and perioperative Handwashing is the single most important
teamwork, improved illumination and visualiza- aspect of preventing transmission of infectious
tion during surgical procedures, and, most impor- diseases and yet evidence suggests highly
tantly, improved surgical flow and utilization of variable rates of handwashing in and around the
physical resources. Only through an enhanced operating room [59]. The literature reveals that
understanding of the underlying issues and pro- the location of sinks in the path of the provid-
cesses that are currently not working in hospitals ers’ workflow process improves handwashing
today that a design team can truly respond with compliance [60, 61]. Despite efforts to achieve
handwashing compliance, infection transmis- Form Follows Safe Surgical Function

sion via hand contact continues to be a promi-
nent adverse event in hospitals today. According Given the persistent adverse events reported by
to Zimring et al., architects and interior design- the Joint Commission, a future of financial
ers should be considering that designing for no- rewards being tied to quality and service in lieu
touch is encouraged moving forward in facility quantity of procedures, the perioperative surgical
design [61]. The inclusion of antimicrobial service line is poised to explore and eradicate the
properties into surfaces results in a reduction of pernicious problems associated with the surgical
microbial loading on surfaces in the laboratory; hospitalization. From bottlenecks in throughput
however the research which correlated to posi- to excessive hunting and gathering of instruments
tive outcomes in the field is minimal to date during a procedure, renovation and new construc-
[62]. Reducing the environmental factors asso- tion is a once-in-a-lifetime opportunity for creat-
ciated with transmission by hand contact ing a surgical workplace that meets the needs of
requires surface products that (1) are chemi- the front-line practitioners.
cally compatible with facility cleaning agents, Focusing on efficiency, effectiveness, and ser-
(2) withstand the contact time of the cleaning vice for both the provider and the patient (a human-
agent, and (3) withstand the friction of surface centered approach) will certainly raise the bar in
rubbing. meeting the triple-aim goals. Using the previous
Finally, family engagement has strong posi- chapters in this book can serve as a checklist in
tive outcomes on reducing stress levels, offering addressing safe surgical care in addition to effi-
social support, and facilitating compliance with cient care. It is wise for physicians and administra-
discharge instructions [63]. Careful consider- tors to be in alignment with a strategic vision for
ation in designing accommodations for family is safe perioperative services before design begins.
a valuable process. Offering the amenities for
comfortable waiting, sleeping, and remote access
to work results in a return on investments as well Key Steps for Pre-design
as healthcare consumer loyalty.
1 . Form a task group.
2. Include front-line practitioner super users.
Patient Well-Being and Family 3. Formulate a strategic action plan to improve
Satisfaction processes based on baseline data.
4. Use design thinking and/or engage Lean Six
1. Ceilings—noise reduction coefficient should Sigma consultants.
be ≥0.80 to reduce ambient noise-associated 5. Test operational changes before architectural
improved sleep quality and stress reduction. programming and planning begins.
2. Furniture—room configuration should facili- 6. Evaluate the likelihood/readiness in adoption
tate furniture layouts that enhance eye-to-eye of processes.
contact between patient, family, and multidis- 7. Keep current quality metrics transparent to
ciplinary postoperative team. influence behavior change.
3. Positive distractions—should provide stress- 8. Engage healthcare-credentialed architects and
reducing attributes associated with pain toler- interior designers.
ance and stress reduction.
4. Wayfinding—architectural elements, use of
A building cannot change culture, and improve
color, art, or sculpture should provide memo- outcomes as one sole intervention to a service
rable impressions to facilitate ease in naviga- line. Architects must now come to the table with
tion to destination points throughout the more than a physical product created in a vac-
continuum. Areas of rest including benches uum. A human-centered approach using a multi-
with arms are encouraged as respite places for disciplinary team can create solutions to new
the patients with dyspnea. processes, services, IT-powered interactions,
ways of communicating, and ways to reduce sys- Hauppauge: Nova Publishers; 2010. p. 1–36. ISBN
978-1-60876-911-7.
tem failures. Through advances in material sci-
7. Galvan C, Bacha EA, Mohr J, Barach P. A human fac-
ence and manufacturing, design professionals are tors approach to understanding patient safety during
now, and will continue to be, equipped with pediatric cardiac surgery. Progr Pediatr Cardiol.
enhanced finish performance characteristics to 2005;20(1):13–20.
8. Barach P, Johnson J, Ahmed A, Galvan C, Bognar A,
enhance human performance and well-being
Duncan R, Starr J, Bacha E. Intraoperative adverse
[64]. It is also hopeful that in the very near future, events and their impact on pediatric cardiac surgery: a
construction regulations will offer the designer prospective observational study. J Thorac Cardiovasc
opportunities to increase the specification of Surg. 2008;136(6):142.
noise reduction materials in order to facilitate
speech recognition and cognitive performance cal practice, part 2. Progr Pediatr Cardiol.
while meeting infection transmission protocols in 2012;33:57–65.
procedure rooms. 10. Schraagen JM, Schouten T, Smit M, Haas F, van der
Beek D, Barach P. Assessing and improving team-
Form must follow well-designed operations,
work in cardiac surgery. Qual Saf Health Care.
operations grounded in safety. Cultural change, 2010;19(6):e29.
teamwork, and coordination augmented by tech- 11. Waring J, Harrison S, McDonald R. A culture of

nology across the continuum must be a system- safety or coping: ritualistic behaviours in the operat-
ing department. J Health Serv Res Policy. 2007;12
wide vision for value-based, evidence-based
Suppl 1:s1–3–9.
design to come to realization. The architect and 12. Barach P, Potter-Forbes M, Forbes I. Designing safe
interior designer must also come to the table with intensive care units of the future, intensive and critical
suggestions and current trends, for augmenting care medicine, World Federation of Societies of
Intensive and Critical Care Medicine. Springer; 2009.
the necessary cultural change by virtue of the
p. 525–41.
built environment. 13. Balik B, Conway J, Zipperer L, Watson J. Achieving
an exceptional patient and family experience of inpa-
tient hospital care. IHI innovation series white paper.
Cambridge: Institute for Healthcare Improvement;
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61–125.
Building Surgical Expertise
Through the Science of Continuous 13
Learning and Training
Peter Hani Cosman, Pramudith Sirimanna,
and Paul Barach
“Coming together is a beginning. Keeping together is progress. Working together is

success.”
—Henry Ford
acquisition; instead, it is building upon, and being

earning and Expert Decision
L shaped by, previously established knowledge,
Making leading to the development of expertise in a par-
ticular domain. Learning in the clinical domain is
Learning is the acquired, relatively permanent or thus facilitated by the principles of adult learn-
persistent change of behavior or behavior poten- ing—or andragogy, as elucidated by Malcolm
tial resulting from instruction, training, and prac- Knowles [2]—in that learning is:
tice (intentional learning) or experience (incidental
learning) [1]. In the context of professional train- • Autonomous and self-directed
ing at a graduate level, it is goal oriented and • Experiential
motivated by progress towards independent prac- • Relevant and goal directed
tice. In this setting, it is more than just factual • Heuristic
P.H. Cosman, BA, MBBS, PhD, FRACS, FICS, In 1984, Kolb described an experiential learn-
FACS (*) ing model, which postulated that learning occurs
Upper Gastrointestinal and Hepatopancreaticobiliary through a cycle of reflective observations of con-
Surgery, Western Sydney University Clinical School,
crete experiences in order to gain an understanding
Liverpool Hospital, Level 2, Clinical Building,
Corner Elizabeth and Goulburn Streets, Liverpool, of what can be learned from each experience [3].
NSW 2170, Australia New ideas are then applied to future experiences,
e-mail: [email protected] renewing the cycle. While this model is readily
P. Sirimanna, MBBS, BSc applicable to many aspects of medical education,
General Surgery, Liverpool Hospital, Corner of the unique necessity to regularly perform technical
Elizabeth and Golburn Streets, Liverpool, NSW
tasks requiring complex motor skills within sur-
2170, Australia
e-mail: [email protected]; psir5541@uni. gery results in the need for an additional approach
sydney.edu.au to learning. In this regard, the three-staged model
P. Barach, BSc, MD, MPH, Maj (ret.) of motor skill acquisition defined by Fitts and
Clinical Professor, Children’s Cardiomyopathy Posner has been suggested as a theoretical frame-
Foundation and Kyle John Rymiszewski Research work uniquely positioned for learning surgical
Scholar, Children’s Hospital of Michigan,
skills [4]. This model initially involves under-
Wayne State University School of Medicine, 5057
Woodward Avenue, Suite 13001, Detroit, MI 48202, USA standing of the relevant task with the aid of instruc-
e-mail: [email protected] tor explanation and demonstration (cognition),

186 P.H. Cosman et al.
followed by practice using instructor feedback to Within the surgical domain, some have defined
identify and eliminate errors (association). Finally, expert status as “experienced surgeons with con-
with repetitive practice, the learner performs the sistently better outcomes than nonexperts” [13].
task with little or no cognitive input. Training to While operative volume has been shown to be an
this “automated” phase can, indeed, result in the important determinant of outcome [14], varia-
development of technical proficiency, but the tions in performance exist between surgeons with
attainment of surgical expertise and decision mak- high and very high volumes making it difficult to
ing requires the development of other cognitive define minimum volume requirements as a sole
attributes [5]. This is supported by the notion of criterion for expertise. Moreover, the number of
“routine” experts that are skilled executors of cer- years of experience has been shown to be a poor
tain tasks but are unable to adequately adapt to predictor of performance [15]. Indeed, for some
“variations from the norm.” As such, many profes- cognitive tasks, more experienced surgeons have
sionals may not attain true expertise. At present, worse performance as a result of decay of previ-
there are no validated tools that reliably distin- ously obtained skills [16]. Recent studies have
guish between or predict those who will and those found that expert surgeons demonstrate greater
who will not attain true expertise [6]. dexterity, consistency, and automaticity of per-
formance, thus freeing up cognitive decision
space [13, 17]. This ability to automate actions
haracteristics of Expertise
C has been demonstrated by the facility to perform
and Expert Behavior tasks seemingly without any attentional effort
and with the cognitive reserve to be able to mul-
Many descriptions of what determines expertise titask without loss of efficiency [17]. Beyond this
are qualitative in nature, with limited concrete mea- capability, experts have a greater ability to moni-
sures available. In the most general terms, the hall- tor and analyze their own performance and,
mark of expert performance is extemporaneous, importantly, identify and correct errors prospec-
reliably reproduced, faster output of a consistently tively [18, 19]. In contrast, nonexperts lack this
higher quality domain-specific product [7]. The key insight and require external evaluators to do
actions of skilled experts in domain-specific tasks this. Experts perform physical rehearsal and
tend to be more fluid than those of novices [8], and warm-up with preliminary findings suggesting
tend not to be under conscious control directly, but that preoperative rehearsal or warm-up can
rather hierarchically, through a higher level archi- improve the performance of operators or operat-
tecture of stratified control, allowing them to divide ing teams [20]. Indeed, experts use forward rea-
their attention between a number of tasks, without soning to rapidly formulate diagnoses and
commensurate loss of performance [9]. Experts are management strategies, making fewer cognitive
better than novices at pattern recognition within errors, but will revert to backward reasoning
their area of expertise, and can more reliably pre- when unusual clinical patterns occur [18, 21–25].
dict forthcoming events and potential problems on This nimbleness is a mark of true expertise and
the basis of limited information [10]. They display allows them to develop reliable mental models to
superior problem- solving skills within their address a wide variety of cognitive challenges.
domain, and have more efficient memory-handling It is well known that individual trainees
algorithms for domain-specific knowledge, as well acquire skills at varying rates and some may not
as measures for qualitative analysis of problems on ever be able to achieve certain proficiencies.
the fly [11], often referred to as “cognition in the Further, surgeons with equivalent operative expe-
wild.” Experts monitor their own performance and rience demonstrate varying levels of skill [26,
are skilled at detecting and correcting errors in their 27]. Equally, some with varying operating expe-
own task execution, whereas novices are dependent rience have been shown to have similar levels of
on external feedback as the principal method of performance [26, 27]. Neurophysiological analy-
error detection [12]. ses have suggested that this disparity may be
13 Building Surgical Expertise Through the Science of Continuous Learning and Training 187
explained by differences in motor learning previously experienced. These task-specific

capability, cortical function, and neuroplasticity, adaptations enable the more effective processing
where experts have been shown to activate a of contextual information [36].
smaller neural networks allowing a more efficient Broadly, clinical decision making involves
control of movement and the development of two types of mental processes that exist on a
automaticity [28, 29]. spectrum, from subconscious, automatic decision
Significant variation in clinical competencies making based on experience and pattern recogni-
exists between individual healthcare providers that tion to a conscious, analytical, thoughtful process
may contribute to a large variation in patient out- [37]. The former is faster and consumes little
comes and inefficient use of resources. Although cognitive energy and is more commonly used by
increasing experience plays an essential role in expert surgeons. However, they are also able to
achieving proficiency, completing more proce- seamlessly switch between these processes pro-
dures does not necessarily ensure that expertise spectively when required. Although the attain-
will be attained if reflection, feedback, and learn- ment of technical proficiency is seen as the
ing are limited. Utilizing examples from sports predominant goal of most surgical trainees,
and music, Ericsson hypothesized that years of achieving status as an expert surgeon requires a
deliberate practice, rather than the mere accumula- more holistic set of competencies. Indeed, it is
tion of experience, is a unifying feature of all clinical decision making that often differentiates
experts [30]. Deliberate practice is defined as a experts from nonexperts more than technical
“structured activity, which is designed to develop a skills per se. These individuals display the ability
critical aspect of current performance.” The devel- to utilize a wide range of conscious and uncon-
opment of expertise is thought to be a consequence scious thought processes to make accurate and
of the amount of domain-specific deliberate prac- rapid clinical decisions consistently, while being
tice accumulated by individuals throughout their able to adapt to the changing demands of the
career, rather than mere exposure to the perfor- patient, the team, and the context. In particular,
mance domain. Deliberate practice provides an they are able to make accurate decisions with
opportunity for error detection and correction, rep- regard to when operative or nonoperative man-
etition, access to feedback, complete concentra- agement is required, ensuring that the right oper-
tion, and full attention. The hallmark of deliberate ation is performed in the right patient with the
practice is a deep desire to receive specific feed- right resources and perhaps, more importantly,
back to identify weaknesses and improve perfor- deciding not to proceed when operating on the
mance [31]. These areas of performance weakness patient is not in the patient’s best interest. Experts
can be practiced “deliberately” by constructing make astute decisions regarding preparing
and seeking out training opportunities in order to patients for surgical procedures, and, importantly,
improve performance. Studies in several domains are able to monitor and detect subtle deviations
have demonstrated that the attainment of expertise from the usual postoperative course, and act
occurs after 10,000 h of a concerted cycle of delib- accordingly to ensure early rescuing of patients
erate practice [30]. while optimizing outcomes.
The relationship between expert performance As mentioned, while the attainment of exper-
and volume of domain-specific deliberate prac- tise is the common goal of all surgical trainees,
tice has been consistently demonstrated across some have controversially suggested that not all
diverse professional domains, including sport trainees have the innate ability to reach such pro-
[32], music [31], business [33], nursing [34], and ficiency and selection of trainees should focus on
academia [35]. These studies suggest that engage- identifying those that are most likely to succeed
ment in structured practice leads to the develop- [38]. Further, becoming a surgical expert requires
ment of task-specific knowledge that helps skilled more than achieving expertise in technical skills
individuals focus their attention on more perti- but in fact requires a suite of both technical and
nent areas of the display, making it easier to sur- nontechnical competencies including the right
mise situational probabilities from events attitudes. Proficiently working within a team is
crucial to efficient and effective delivery of surgi- ongoing staff training and workplace assessment
cal care [39]. These topics are discussed in the of these nontechnical skills will yield dividends
next sections. in terms of improved quality and efficiency in
delivery of care to patients [46]. Given this reli-
ance on continuous training, thought ought to be
earning Within the Surgical
L given to the best way to incorporate training into
Microsystem the microsystem’s schedule, and the various
training needs of its members.
Clinical microsystems provide a conceptual and
practical framework for thinking about the orga-
nization and delivery of care. Formed around a earning at Various Stages
L
common purpose or need and often embedded of Training/Levels of Expertise
within larger organizations, a clinical microsys-
tem is a small, inter-reliant group of people work- Dreyfus and Dreyfus proposed a model of skill
ing together regularly to care for specific patient acquisition [47] that describes how students
groups [40]. It is characterized by a common aim, acquire new skills through formal instruction and
a subpopulation of patients, shared work pro- practicing. The original model proposes that a
cesses, and a shared information environment student passes through five distinct and immer-
[41]. Optimally functioning clinical microsys- sive stages: novice, competence, proficiency,
tems deliver the best quality healthcare services, expertise, and mastery which correspond to four
so understanding what is most important to the binary qualities around: recollection (non-situa-
people who make up the microsystem is key to tional or situational); recognition (decomposed
continuous improvement. The main driver and or holistic); decision (analytical or intuitive); and
facilitator of learning within this environment is awareness (monitoring or absorbed). In the nov-
its internal climate and culture [42]. Awareness of ice stage, a person follows rules as given, without
the presence and support of the microsystem by context, with no sense of responsibility beyond
its members, and support for its activity by the following the rules exactly. Competence devel-
broader organization within which it is embed- ops when the individual develops organizing
ded, is therefore, essential for the function of the principles to quickly access the particular rules
microsystem—a critical factor in its key purpose that are relevant to the specific task at hand;
of continuous quality improvement and the pro- hence, competence is characterized by active
vision of reliably safe clinical care [43]. decision making in choosing a course of action.
This environment socializes the team mem- Proficiency is shown by individuals who develop
bers, and affords the acquisition of unique set of intuition to guide their decisions and devise their
technical, but mainly nontechnical, skills, and own rules to formulate plans. The progression is
some of which can only be attained with great thus from rigid adherence to rules to an intuitive
difficulty outside of the relevant micro-system mode of reasoning based on tacit knowledge.
[44]. General microsystems include doctors, This model leads to five defined roles, through
nurses, other healthcare providers, administrative which learners can progress in either direction
support such as clerks and biomedical engineers, and share elements of two stages at different
and health information technologies that support times in their learning journey [48] (Fig. 13.1).
them. Understanding the interdependent inter- With specific reference to psychomotor skills,
faces and subtleties of communication between learning occurs in three phases [49], although the
staff of differing disciplines is explored by par- entire process of learning is a continuous, not a
ticipation in interdisciplinary learning activities, discrete, phenomenon. The first is the declarative
often enhanced by simulation- based learning stage (composition, cognitive stage), in which
activities. Leadership and teamwork are also the basic rules of a task are articulated and learnt.
important aspects of the microsystem’s success Next is the associative stage (proceduralization
[45], and attention given to providing constant stage), during which the procedures of the task
Fig. 13.1 Dreyfus model of skill acquisition [47]
become more fluent. Finally, during the autono- we do [52–54]. The principles that govern their
mous stage, the procedures become automated, formation and function are common to all humans,
being performed more rapidly and with greater which is why we can agree on many facets of
immunity to disruption by external conditions experience, despite each individual’s complete
such as noise, interruptions, etc. The most dra- ignorance of another’s experience. According to
matic and rapid changes in performance are seen the Gestalt view, our experience of objects in the
in the first phase, and a plateau is reached by the real world consists of a number of facets of each
third stage, although performance slowly contin- object—such as color, texture, odor, and so on—
ues to improve by small increments over long each of which generates a particular stimulus. Our
periods associated with ongoing practice immediate mental state, together with our previ-
(Fig. 13.1). ous experiences, determines the relative value we
The first two stages are associated with the attach to each facet of an object. Although the
evolution of increasingly more appropriate men- sensory abilities of experts do not differ from
tal representations of action [50]. This Kantian those of novices, their perception of entities spe-
representation—also known as a schema— cific to their domains is different. The pattern of
“… is a spatially and/or temporally organized relative importance of the facets of an object in
structure in which the parts are connected on the experience that are pertinent to the expert’s func-
basis of contiguities that have been experienced in tion is—in a manner of speaking—imprinted on
space or time. A schema is formed on the basis of his or her memory. This explains the expert’s
past experience with objects, scenes, or events and
consists of a set or (usually unconscious) expecta- superior cognitive processing in approaching or
tions about what things look like and/or the order performing a task, and this is what training for
in which they occur.” [51] that task must accomplish [55].
Within the schema is housed the action plan
This mental organization is not peculiar to [56], a hierarchy of seven levels of sensorimotor
experts; according to the Gestalt theory of psy- representation postulated by Saltzman [57]. The
chology, schemata underpin all our experience of seven levels are defined in Table 13.1. Experts
the world, and cause us to perceive things the way performing a psychomotor task within their skill
Table 13.1 Saltzman’s levels of sensorimotor representation [57]

Level of representation Characteristics Example
1. Conceptual This level involves highly abstract “Perform a mass abdominal
symbolic components integrated closure,” and “Make a
within a logical or propositional circumareolar incision.” Specific
framework spatiotemporal parameters are
defined only insofar as they relate to
operational components of the
entities to be manipulated
2. Environmental space motion At this level, the interaction space is “Take 2 cm bites, 1 cm apart,” and,
defined, along with quantitative “Start at the 4 o’clock position, and
representations of the relative finish at the 8 o’clock position,”
positions of the objects within it to exemplify this level of control
be manipulated
3. Effector At this level, a particular effector “Pick up the fascia with the forceps
system will be selected to perform in your left hand,” and “Hold the
the task, and its relationship with the scalpel in your right hand”
task objects will be quantitatively
defined
4. Body-space motion At this level, the higher order “Hold the forceps like a pencil,” and
information is translated into specific “Keep your elbows by your sides”
instructions on movement of the
performer’s body within space.
Transformation of the environmental
spatiotemporal action trajectory is
translated into body-relevant terms
5. Joint motion The angle of each joint between the Maintaining a fluid and flexible,
fingertips and trunk is defined for nonrigid posture in those joints not
proper execution of the task, along involved in performing the task
with kinematic changes in the angles
over time, angular velocity, and
angular acceleration. Experts can
ignore the redundant degrees of
freedom in their joints, identifying
only those that are necessary for task
completion; by contrast, novices
cannot predict which degrees of
freedom are redundant for a
particular task
6. Joint torque This is a function of the angular
displacement, velocity, and
acceleration of a joint, and
determines the amount of force
applied to objects in the task.
Adjustments at this level result in
greater or lesser amounts of traction
applied to tissues
7. Muscle At this level, the relevant muscle
groups to be activated are
determined, as is the required neural
input
domain generally operate at the conceptual level and repetitive feedback at most, if not all, levels
of representation, regarded as the highest order or of sensorimotor control.
most abstracted level of control. In contrast, nov- Mental schemata are also responsible for the
ices training to achieve expert-level proficiency general popularity of “mind maps” as an
in a particular skill are likely to require i nstruction aide-mémoire based on the organization of vari-
ous related pieces of information into a structured 5. Indications of difficulty

framework [58]. One aspect which does set Recognizing the signs of potential difficul-
experts apart from the remainder of the popula- ties is the first step in preparing for these con-
tion, however, is that they possess highly devel- tingencies. One feature of expert performance
oped and structured mental representations for is awareness of all contingencies during task
information within their area of expertise [59], performance, and prior preparation of strate-
which facilitates their professional functionality. gies to avoid difficulty [60], or to attenuate its
This ability is specific to their knowledge domain, effects should it eventuate. This suite of skills
but does not extend to general function in com- may explain the benefits of rehearsal before
mon tasks [60]. It is for this reason that correla- procedures.
tions have been found between surgical 6. Cue indications
proficiency and visuospatial ability [61]. Information from the task environment is
Successful execution of a task, then, is predi- necessary for decision making during certain
cated on the presence within the performer’s tasks, and for monitoring performance. These
mind of a schematic model of the task synthe- cues also assist in coordinating task execution
sized during the course of training. Proficiency in by indicating the deployment of subordinate
task performance emerges when the trainee’s processes at the appropriate time [63].
performance matches his or her mental schematic 7. Conditions which initiate and end the task
of the task, as long as the model is sufficiently The operator must be able to correctly
sophisticated to encompass the task parameters match initiation of a task to the circumstances
outlined below [62]: that require it. Similarly, he or she must be
able to recognize the achievement of the goal
1. Task content, type, input, output conditions that the task is designed to fulfil, as
The actions or processes which constitute well as be able to recognize circumstances
the task define the nature of the task itself, that leading to futile pursuit of the goal, under
is, whether it is predominantly sensory, cogni- which it is more prudent to abort the task.
tive, or motor, or a combination of two or 8. Constraints/aids provided by environmental
more abilities. These broad classifications of or technological factors
task type can be further stratified by the type The operator must also know the resources
of activity involved. Knowledge of the mate- available to assist in task completion, as well
rial—the “task substrates”—required to comas the various factors that may limit an aspect
plete the task and a mental model of the end of performance. Taken to its extreme, this prin-
product are essential. ciple directs the operator to be aware of his or
2. Contextual conditions her own limitations, and of any conditions that
Factors beyond the immediate constituents may place successful task completion beyond
of the task which may affect task performance the resources at his or her disposal.
must also be recognized. 9. Alternative means of reaching the desired
3. Frequency and duration outcome
Tasks may involve several iterations of sub- Achieving the goal conditions may occa-
ordinate processes; the operator must know sionally necessitate use of an alternative to the
how to determine the appropriate number of task in question, and the operator must be pre-
repetitions. Timing factors may also play an pared for such strategy changes.
important part in successful task execution.
4. Criticality The scope of the foregoing list of elements
Certain elements of a task may be pivotal which form the mental construct of a task indicates
to its successful execution. Awareness of such that two classes of knowledge are essential to
elements allows the performer to take steps to achieving proficiency in a psychomotor skill.
ensure optimum performance of these Declarative knowledge (semantic knowledge,
elements. conceptual knowledge, or factual knowledge)
relates to the principles underlying the task. number of clinical and nontechnical skill sta-
Procedural knowledge (operational knowledge), tions that aim to assess these competencies. A
on the other hand, relates to the internal task struc- recent study evaluating the predictive validity of
ture. Declarative knowledge does not appear to this process demonstrated that those who
enhance task performance, and its utility depends obtained high score in the CV component of the
on the way it is presented to the learner. Measures selection process did not score higher in any sub-
of this kind of knowledge are not good predictors sequent objective work-based assessments dur-
of task performance [64], and it does not affect ing training. In contrast, referee reports and
skill transfer [65], although it may improve long- interview scores, as well as the overall score,
term retention. Procedural knowledge, on the other positively correlated with performance during
hand, is important for effecting skill transfer [66]. subsequent objective work-based assessments
during the training program [71].
This traditional selection process has been
ecruiting and Training the Surgical
R controversially criticized by some for not includ-
Team ing assessment of abilities that are fundamental to
surgical practice, such as psychomotor skills [68].
Recruiting the most suitable candidates is a task Recent advancements in surgical practice—in the
that has continuously challenged surgical educa- form of endoluminal techniques, complex laparo-
tors worldwide. Indeed, identification of appro- scopic procedures, microsurgery, and robotic sur-
priate selection criteria is an onerous task, often gery—require surgeons to possess a number of
supported by scant evidence [67]. However, this critical abilities across the cognitive, psychomo-
controversial topic has gained much interest in tor, and visuospatial domains beyond those
recent times, particularly given the increased required for traditional surgical modalities [68,
economic pressures, growing cost of training, 72–77]. Further, some of these fundamental abili-
and accountability placed upon training bodies. ties have been considered largely innate, and it is
This, coupled with the reduction in working debated whether these abilities can be acquired
hours available for training, means that selection and mastered through training at all [77]. This
of trainees that are most likely to succeed through clearly has implications for the benefit, cost-effec-
training is vital [68–70]. Traditionally, selection tiveness, and safety of individuals without these
of prospective surgeons into training programs is innate abilities undergoing the lengthy, rigorous,
based largely on three aspects: clinical experi- and expensive process of surgical training. Within
ence and academic achievements, referee other high-risk industries, like aviation and the
reports, and performance at interview. In military, assessments of attributes deemed impor-
Australia and New Zealand, this highly competi- tant for performance are incorporated into the
tive process adheres to the aforementioned prin- selection process [78]. Cuschieri and colleagues
ciples, where a self-reported structured surveyed the opinion of senior surgeons and sur-
curriculum vitae (CV) is scored according to gical leaders from Europe and the USA with
strict criteria with points given for clinical expe- regard to the attributes they considered to be
rience, publications and presentations, teaching, important for selection of surgical trainees [79].
higher degrees, and postgraduate prizes. Further, The authors concluded that innate dexterity
referee reports are collated from nominated clin- including the abilities of spatial perception, hand-
ical supervisors that involve scoring applicants eye coordination, aiming, multi-limb coordina-
according to the Royal Australasian College of tion, and hand-arm steadiness and the ability to
Surgeons (RACS) competencies of medical and interpret and manipulate images is considered by
technical expertise, clinical decision making and this group of expert surgeons to be an important
judgment, collaboration and communication, selection criteria. Indeed, when these fundamen-
professionalism academic, teaching, and leader- tal abilities were present in a trainee, improved
ship aptitudes. Finally, applicants are scored dur- performance correlated with shorter time to profi-
ing a semi-structured interview consisting of a ciency during endoscopic performance [76].
These provocative studies raise questions including communication skills, critical language,
about the reliability and validity of the trainee assertive and closed-loop communication, active
selection process in surgery, as well as identify- listening, and leadership. The scenarios involve
ing those who may require additional training to laparoscopic crisis, laparoscopic troubleshooting,
achieve competence. As a result, tests of techni- latex allergy anaphylaxis, patient handover, pre-
cal skills and fundamental abilities are included operating briefing, as well as trauma team training
in the selection process for Higher Surgical [83]. Performance during the modules is assessed
Training at the Royal College of Surgeons in by specific assessment tools, but other validated
Ireland [80]. Candidates are required to complete nonproprietary instruments can also be used, such
a full day of assessments including a ten-station as the NOTECHS (non-technical skills) scale [83]
surgical skills Objective Structured Clinical and other frameworks [84]. Despite this, it has
Examination (OSCE), where they are tested on been reported that 21 % of 117 surveyed program
skills acquired during basic surgical training. directors were unaware of this curriculum [85].
These include suturing, knot-tying, basic anasto- Further, the implementation rate of Phase III was
mosis, and basic endoscopic and laparoscopic only 16 % [85]; lack of faculty-protected time and
skills. Additionally, candidates undergo a variety personnel, significant costs, and resident work-
of validated assessments of psychomotor skills, hour restrictions were suggested as reasons for this
visuospatial ability, and perception. low figure [85].
Crew resource management (CRM) within
healthcare is a concept that describes the principles
Training the Surgical Team of individual and crew behavior during ordinary
and crisis situations, and aims to optimize available
To meet the demands of increasingly complex health- resources and develop skills in dynamic decision
care associated with delivering high-quality, efficient making, interpersonal behavior, and teamwork that
surgical care, the concept of the surgical team has lead to safe outcomes [86–88]. Emerging from
changed significantly [81]. No longer can the sur- other high-risk industries, such as aviation, CRM
geon operate as a patriarchal figure issuing orders has been successfully applied to healthcare since
with regard to all aspects of patient care. In order to the mid-1980s with a number of variants and
provide the highest quality holistic and efficient care, hybrids being developed [89]. The development of
surgeons must work collaboratively as equals with the Team Strategies and Tools to Enhance
nursing, allied health, other medical, and administra- Performance and Patient Safety (TeamSTEPPSTM)
tive colleagues. Together this group of individuals program, as a variation of CRM, by collaboration
constitutes the surgical team with the shared goal of between the Agency for Healthcare Research and
delivering the best care possible for their patients. Quality and the United States Department of
Working within such an intricate system containing Defence has provided a standardized evidence-
so many moving parts poses another challenge to sur- based curriculum for team training for healthcare
gical trainees beyond the pursuit of technical excel- providers [90, 91]. At its core, TeamSTEPPSTM
lence. Furthermore, traditionally, surgical training aims to teach four fundamental competencies that
programs focus little on training and assessing skills constitute teamwork (leadership, situation moni-
required to be a proficient collaborator. toring, mutual support, and communication) with
In 2008, the American College of Surgeons the aid of patient scenarios, case studies, multime-
(ACS) and Association of Program Directors in dia, and simulation [92]. Having been implemented
Surgery (APDS) united to create Phase III of the in multiple regional training centers around the
ACS/APDS National Curriculum [82]. Contained USA and Australia [93], the TeamSTEPPSTM pro-
within this was a course of team training modules gram has been shown to enhance teamwork within
that incorporated a number of validated simulation the operating room, improving operating room effi-
scenarios to be used with human patient simula- ciency and reducing patient safety concerns in the
tors. These modules were specifically designed to process [94, 95]. Additionally, it has been demon-
teach a wide range of team-related competencies strated to increase perceptions and attitudes with
regard to patient safety culture, teamwork, and still limited due to a lack of appreciation of the
communication [42, 94, 96]. A recent study inves- benefits of training, potential savings in opera-
tigated the use of CRM within the surgical ward tions, harm reduction, and building trust between
environment, in which surgical trainees partici- team members. Recently, virtual reality models
pated in simulated ward-based scenarios of a dete- of the OR have been developed and used for team
riorating postoperative patient before and after training [104], but further research is needed to
CRM training [97]. CRM training improved clini- appreciate the ethical dimension, effectiveness,
cal assessment and decision making and resulted in transfer of training and demonstrate the effect on
improvements in teamwork, communication, and team skills on patient outcomes [105, 106].
leadership [97].
Effective and efficient teamwork within the
operating room (OR) is crucial to prevent process Assessing Expertise
failures and adverse patient events during an
operation [98]. The OR team is further subdi- Surgical expertise encompasses a wide range of
vided into specialized collaborations that include competencies. Holistic analysis of a surgeon’s
the surgical team (surgeon, surgical assistant, and professional and technical performance ideally
scrub nurse), anesthetic team (anesthesiologist incorporates reliable assessments of these indi-
and anesthetic nurse), and theatre nursing staff vidual competencies. Assessment of surgical
(scrub nurse and scout nurse) [81]. Teamwork expertise must start with shared evidence driven
can have a huge impact in the OR on patient definitions and has been compartmentalized into
safety and resulted in development of strategies technical and nontechnical skills, with a variety
to reduce complications such as medication of methodologies developed to do this [107, 108].
errors, positioning errors, and more, and train Some of these are discussed below, but ulti-
individuals to work efficiently and collabora- mately, the most important and relevant measure
tively not only within their own sub-team, but of expertise, using an expert performance and
also within the entire OR team. The development assessment approach, [5] is a robust evaluation of
of simulated ORs that replicate the entire OR patient process and outcomes measures, both at
environment has provided a unique opportunity the level of the individual practitioner [109] and
[44] to cultivate a number of nontechnical skills, at the microsystem level [84]. Just as error detec-
including command, control, and conflict resolution and analysis reflect expert performance by
tion teamwork [99]. Real equipment as well as an individual [110], the same strategy applied to
virtual reality and mannequin simulators are teamwork will yield dividends in terms of the
incorporated into this simulated setting [100]. team’s collective expertise [40, 44].
This allows trainee surgical, anesthetic, and nurs-
ing staff to interact and practice teamwork skills
together, while simultaneously performing tech- Technical Skills
nical tasks, during a variety of routine and crisis
scenarios, just as they would in “real life” [40, There are a multitude of methods for measuring
99, 101]. Indeed, Gettman et al. demonstrated an technical skills in surgery that use varying
improvement of the teamwork, communication, degrees of complexity [111, 112]. These range
and laparoscopic skills of trainees undergoing from measurement of simple metrics, such as
training within a simulated OR [102]. Further, time and dexterity, through to global and
the simulated OR was validated as realistic and procedure-specific rating scales and error-based
representative of actual practice [102]. Other checklists, as well as more complex assessments
studies have similarly shown the benefits of col- of higher level cognitive function using gaze
laborative training within a simulator OR envi- tracking and functional brain imaging.
ronment on trainees’ nontechnical skills including Motion analysis systems, such as the Imperial
teamwork and situational awareness [103]. College Surgical Assessment Device (ICSAD),
Widespread use of simulated ORs for training is use an electromagnetic tracking system that
monitors the motion through space of sensors as gaze tracking and functional brain imaging. By
placed on the dorsum of the surgeon’s hands to using stationary cameras or cameras integrated
record a variety of dexterity parameters, such as into standard eyeglasses to record corneal reflec-
time to task completion and economy of motion tion of infrared light, pupil position can be tracked
[99]. This system has been validated as an objec- to generate a map of the surgeon’s focus of atten-
tive assessment tool, and can distinguish between tion during surgery [84, 123]. Additionally, other
surgeons of differing skill levels [113, 114]. eye metrics can be obtained, including fixation
Likewise, virtual reality surgical simulators pro- frequency and dwell time; these indicate the
vide an opportunity for users to practice tasks of degree of importance ascribed by the surgeon to a
varying complexity and produce similar objec- particular stimulus. In addition, pupillary dilation
tive measures of dexterity, as well as record errors is a surrogate marker of effort and concentration.
made, in real time. Not only have such models Indeed, a recent systematic review concluded that
been validated as accurate assessment tools, but gaze tracking is feasible and valid as an objective
they have also been used to evaluate expert skill measure of ability, and can produce reliable quan-
level to generate performance goals for trainees titative data differentiating between varying levels
to practice within structured curricula [115, 116]. of surgical skill [123].
In contrast to the aforementioned dexterity Similarly, the use of functional brain imaging
assessment tools, direct observational assessment provides a novel approach to measuring surgical
tools utilize rating scales to quantitatively assess proficiency. Functional magnetic resonance
the quality of operative performance. Broadly imaging (fMRI) has been utilized in other highly
classified into global and procedure-specific rat- skilled domains such as sport and music [124,
ing scales, these tools require an observer to eval- 125]. In a recent feasibility study using fMRI,
uate performance. Global rating scales, such as Morris measured the blood oxygen level-
the Objective Structured Assessment of Technical dependent signal changes (BOLD) in specific
Skill (OSATS) scale, assess generic operative brain regions while subjects performed and imag-
skills, such as respect for tissue and instrument ined performing hand tying of surgical knots
handling. The OSATS scale has been demon- [126]. Decreased BOLD activity was observed
strated to be a reliable and valid method of assess- during knot-tying by experts when compared to
ing operative skill in both the simulated and novices. Further, increased BOLD activity was
actual operating room environment [114, 117]. observed in experts when imagining performing
Nevertheless, the lack of ability to provide feed- hand ties compared to novices. This study dem-
back on specific aspects of a particular procedure onstrated that using fMRI to assess surgical skill
has led to the development of procedure-specific was feasible and specific regions of interest were
rating scales. These allow objective assessment identified through brain mapping.
of performance during individual operations to Increasingly, attention has been directed to the
define specific areas of weakness that then can be concept of the learning curve in surgery. As a
practiced deliberately. Such tools have been strategy, preoperative warmup and pre-procedure
developed and validated for a number of opera- rehearsal exercises performed by surgeons at all
tions including cholecystectomy, gastric bypass, levels of expertise lead to improved performance
and colorectal, ear, nose, and throat, and cardiac during the operative procedure [24, 127], but also
surgery [44, 114, 118–122]. In a landmark publi- serve to document a surgeon’s learning curve by
cation, Birkmeyer demonstrated that superior longitudinal analysis of repeated performance.
performance by expert surgeons during gastric
bypass surgery—as assessed by a procedure-
specific rating scale—was associated with fewer Nontechnical Skills
postoperative complications, reoperation rates,
readmissions, and, crucially, mortality [109]. Nontechnical skills (NTS) encompass a range of
More recently, more sophisticated methods of competencies, including communication, team-
assessing surgical skill have been developed, such work, leadership, decision making, situational
awareness, managing stress, and coping with The revised NOn-TECHnical Skills
fatigue. In contrast to methods of evaluating techni- (NOTECHS) rating scale is a validated and reli-
cal skills, the assessment of NTS almost exclu- able instrument adapted from the aviation indus-
sively relies on rating scales and checklists that try by Sevdalis and colleagues [137] for use in the
include specific definitions and examples of behav- operating room, and designed to measure the NTS
iors representing superior or substandard perfor- of both the individual surgeon and the team as a
mance at each measured NTS. These tools can be whole [138]. Categorizing NTS into five domains,
used in both the simulated and actual clinical envi- including communication/interaction, situational
ronment, and rely on direct observation of subjects. awareness/vigilance, cooperation/team skills,
Surgeons have been shown to be reasonably accu- leadership/managerial skills, and decision mak-
rate at self-assessing their technical skill, but lack ing, the NOTECHS rating scale can be used in
sufficient insight to accurately self-assess their own real time and requires minimal prior training for
NTS [128]. Several instruments have been created assessors [138]. Mishra developed the Oxford
to evaluate NTS with considerable overlap, demon- NOTECHS, as a variant of the original scale, with
strating the importance of some of these competen- the aim of assessing the NTS of the entire operat-
cies to a number of academic surgical teams. Some ing room team [139], and a modified, higher reso-
of these instruments are discussed below. lution version was subsequently developed, with
One of the pioneering tools for NTS assess- an increased number of performance indicators,
ment is the Observational Teamwork Assessment particularly in the normal spectrum of behavior
for Surgery (OTAS) tool, which was developed in [140]. Further modifications of NOTECHS
2006 [129] to comprehensively assess the inter- include the trauma NOTECHS (T-NOTECHS),
professional teamwork of an entire operating which allows assessment of NTS that are crucial
room team, including communication, coordina- for effective and efficient management of trauma
tion, cooperation/backup behavior, leadership, [141, 142]. Henrickson Parker and colleagues
and team monitoring/situation awareness. While conducted focus group discussions to identify
it is valid and reliable, OTAS requires real-time leadership characteristics of a surgeon [143].
observation, and raters must be adequately These included maintaining standards, managing
trained to use the scale [130]. resources, making decisions, directing, training,
Non-Technical Skills for Surgeons (NOTSS) supporting others, and coping with pressure.
was also developed in 2006 through cognitive task From this, the Surgeons’ Leadership Inventory
analyses with expert surgeons to identify five cate- (SLI) was developed and subsequently demon-
gories of NTS, including situational awareness, strated to be a reliable means of assessing leader-
decision making, task management, leadership, and ship with the operating room [143].
communication/teamwork [131]. While NOTSS “Failure to rescue” patients whose condition
has been demonstrated as a reliable assessment of deteriorates during the postoperative course has
surgeons’ NTS [132], novice assessors tended to been suggested to be responsible for a large pro-
score lower than expert assessors, again indicating portion of variability seen in patient outcomes
the need for formal training in using NOTSS [133]. within surgery. As stated previously, experts are
Crossley evaluated NOTSS as a real-world assess- able to monitor and detect subtle deviations from
ment tool using a mix of minimally trained asses- the usual postoperative course, and act swiftly to
sors and demonstrated evidence to suggest that the prevent such failures. The ability to develop these
scale is reliable and feasible to be used in the actual skills and conduct an efficient, accurate, and safe
operating room [134]. Developed using a similar ward round requires the same deliberate practice
methodology to NOTSS, the Anaesthetists’ Non- required to master technical skills in the operat-
Technical Skills (ANTS) and Scrub Practitioners’ ing room. Recent development and validation of
List of Intraoperative Non-Technical Skills the Surgical Ward care Assessment Tool (SWAT)
(SPLINTS) rating scales have also been shown to has enabled evaluation of patient assessment and
be reliable and valid in assessing NTS of anesthe- management by surgeons [144]. This instrument
tists and instrument nurses [135, 136]. comprises a checklist of assessment tasks, rang-
ing from reviewing the vital signs chart and labo- time must come for all trainees to practice inde-
ratory test results to performing a physical pendently for the first time, and a number of solu-
examination of the abdomen. Additionally, the tions to this difficult decision have been proposed.
checklist includes a number of management One suggestion is to establish a requirement for
tasks, such as reviewing requirements for analge- trainees to achieve a minimum number of
sia, antibiotics, and fluids. Further, the authors attempts, in order to overcome the learning curve
modified the T-NOTECHS scale to produce and for a particular task, prior to allowing indepen-
validate the W-NOTECHS rating scale. For each dent practice [151]. A counterargument accounts
NTS domain—including leadership, coopera- for the variable learning curves of different train-
tion, resource management, communication and ees and supports the use of careful consideration
integration, assessment and decision making, and individualized assessment of trainee compe-
global awareness, and coping with stress—five- tency, stage of training, and appropriateness of
point Likert scales were used to rate performance. the patient for independent practice [152].
Both the SWAT and W-NOTECHS scales have The term “entrustable professional activity”
been demonstrated to reliably assess performance (EPA), coined by ten Cate [153], describes pro-
during ward rounds and provide structure for the fessional tasks that “together constitute the mass
development of expertise in the art of conducting of critical elements that operationally define a
a ward round through a cycle of objective assess- profession.” Each EPA is defined as a unit of
ment and deliberate practice [145]. work that trainees are required to master during
their training, but necessitate entrustment by their
supervisors once they are deemed competent for
Entrustable Professional Activities independent practice. This concept was used by
ten Cate and Scheele [154] to define five levels of
Judging when trainees are equipped for indepen- responsibility of proficiency. These include:
dent unsupervised practice is a challenging
endeavor for both supervisors and trainees. 1. Has knowledge
Premature unsupervised care can place patients 2. May act under full supervision
at an undue risk of harm, increasing the ethical 3. May act under moderate supervision
and legal accountability for the supervisor and 4. May act independently
healthcare organization. A recent meta-analysis 5. May act as a supervisor and instructor
[146] found that clinical supervision of medical
practitioners performing surgical procedures sig- Further, they suggested the utilization of EPAs
nificantly reduced the operative mortality by one- as the backbone for competency-based curricu-
third, and the risk of complications by two-thirds lum development, by awarding a “statement of
following nonsurgical invasive procedures. awarded responsibility” (STAR) for specific
Further, giving trainees inappropriate respon- EPAs, the threshold at which entrustment of inde-
sibilities can negatively affect their learning. pendent practice can be clearly demarcated and
Conversely, affording capable trainees too little formalized. At least four factors were hypothe-
independence can have a detrimental impact on sized as likely to influence such entrustment deci-
their ability to achieve competence and either sions. Firstly, the type of EPA should be
slow or arrest their development. Educational considered. Supervisors should expect trainees to
psychologists describe both of these conditions have slow learning curves for complex, high-risk
as “destructive friction” [147]. Giving trainees EPAs, whereas those EPAs that are frequently
the responsibility to perform tasks that are only encountered by trainees should be associated with
narrowly beyond the limits of their ability has a steeper learning curve. Secondly, supervisors
been suggested to stimulate learning and is should consider the environment in which the
termed “constructive friction” [147–149]. trainee is practicing: Are there adequate resources
However, there is a lack of evidence to support available should a trainee fail the EPA? Does the
this in clinical practice [150]. Nevertheless, a curriculum demand a STAR for the trainee’s stage
of training? Thirdly, the supervisor must assess decisions. Good supervisor-trainee rapport within
and make a deliberate decision regarding each a collaborative environment was more likely to
individual trainee’s competence with each result in greater trainee autonomy.
EPA. Finally, the supervisor must be comfortable Findings such as those mentioned above can
with the EPA, as well as be able to assess the other aid the development of evaluation tools to provide
factors accurately and competently. structure for entrustment decisions and assess
Allied to this, Choo et al. conducted a qualita- whether trainees are ready to practice unsuper-
tive analysis of the factors that influence how vised. Moreover, recognizing the varying learning
supervisors’ and trainees’ perceptions of trust curves of trainees and utilizing EPAs and STARs
impact decision making [155]. Some supervisors can allow the development of competency-based
reported using perceived trainee confidence as a curricula where training is flexible and learning is
barometer of their true ability and comfort, while not only safe [157] but of maximum benefit to the
others reported overconfidence, as defined by the trainee [158]. Multiple studies have demonstrated
inability to recognize limitations, as a red flag for that the information included in the Performance
the need for increased scrutiny. Indeed, the most Evaluation of surgical trainees moving from rota-
important trainee attribute that led to develop- tion to rotation or from residency to fellowship
ment of supervisor trust was adequate medical and onto jobs, can at times fail to reliably predict
knowledge. Further attributes that contributed to residents/trainees’ future performance [159, 160].
entrustment included demonstration of judge- This faulty transfer of information can lead to
ment and applying evidence-based medicine, harm when poorly prepared trainees fail out of
leadership skills, anticipated specialty, and abil- residency or, worse, are shuttled through the med-
ity to recognize limitations. Additionally, several ical education system without an honest account-
supervisors described the use of an early litmus ing of their performance. Such poor learner
test to determine the degree of entrustment handovers likely arise from two root causes: (1)
throughout the trainee’s rotation. An important the absence of agreed-on outcomes of training
attribute highlighted by supervisors included the and/or accepted assessments of those outcomes,
quality and nature of the trainee’s communica- and (2) the lack of standardized ways to commu-
tion skills. An inability to reliably or effectively nicate the results of those assessments. To improve
communicate patient status or supervisor con- the current learner handover situation, an authen-
cerns was deemed as a reason for closer supervi- tic, shared mental model of competency is needed;
sion. The clinical experience, knowledge base, high-quality tools to assess that competency must
and personal involvement in patient care of the be developed and tested; and transparent, reliable,
supervisor also were demonstrated to play a role and safe ways to communicate this information
in entrusting trainees with independent practice. must be created. The CLASS model includes a
Supervisors deemed that increased case com- description of the learner’s Competency attain-
plexity, presence of legal or ethical issues, and ment, a summary of the Learner’s performance,
greater urgency and severity of the clinical sce- an Action list and statement of Situational aware-
nario were drivers of more supervisor input. ness, and Synthesis by the receiving program.
Decision making with regard to patient discharge This model also includes coaching oriented
and transfer was also seen as requiring greater towards improvement along the continuum of
supervision, regardless of case complexity [156]. education and care [161].
Other important factors with regard to entrusting
trainees to practice independently included those
that relate to the context and environment within Future Directions
which the EPA occurs. This included physical
proximity of the supervisor, institutional culture, Surgical teams make fewer mistakes than do
work load, trainee experience and level, time of individuals, especially when each team member
day, and efficiency pressures. Additionally, team knows his or her responsibilities, as well as
dynamics also play a crucial role in entrustment those of the other team members. However,
simply bringing individuals together to perform example, there is little evidence available to date
a specified task does not automatically ensure that provides insight into the frequency of retrain-
that they will function as a team. The role of the ing or dedicated practice needed to develop and
clinical microsystem as the unit of training and maintain effective teamwork skills. Additionally,
measurement is key. Surgical teamwork there is a need to examine how dynamic team
depends on a willingness of clinicians from composition (i.e., changes in team membership,
diverse backgrounds to cooperate in varied absence of key members) moderates team pro-
clinical settings (i.e., clinic, operating theatre, cesses and the effects of team training.
intensive care unit, surgical wards) towards a Turning surgical care experts into expert
shared goal, communicate, work together effec- teams requires substantial planning and practice.
tively, and improve. There is a natural resistance to move beyond indi-
To achieve high reliability and consistent per- vidual roles and accountability to a team mindset.
formance, each team member must be able to (1) One can facilitate this commitment by (1) foster-
anticipate the needs of the others; (2) adjust to ing a shared awareness of each member’s tasks
each other’s actions and to the changing environ- and role on the team through cross-training and
ment; (3) monitor each other’s activities and dis- other team training modalities; (2) training
tribute workload dynamically; and (4) have a members in specific teamwork skills such as

shared understanding of accepted processes, and communication, situation awareness, leadership,
how events and actions should proceed (shared “follower-ship,” resource allocation, and adapt-
mental model). ability; (3) conducting team training in simulated
Teams outperform individuals especially scenarios with a focus on both team behaviors
when performance requires multiple diverse and technical skills; (4) training team leaders in
skills, time constraints, judgment, and experi- the necessary leadership competencies to build
ence. Nevertheless, most people in healthcare and maintain effective teams; and (5) establish-
overlook team-based opportunities for ing reliable methods of team performance evalu-
improvement because training and infrastruc- ation and rapid feedback.
ture are designed around individuals and incen- The roadmap for future research must include
tives are all individual based. Teams with clear how expertise is developed and sustained and
goals and effective communication strategies how teamwork training should be structured,
can adjust to new information with speed and delivered, and evaluated to optimize patient
effectiveness to enhance real-time problem safety in the perioperative setting. For teamwork
solving. Individual behaviors change on a team skills to be assessed and have credibility, team
more readily because team identity is less performance measures must be grounded in team
threatened by change than are individuals. theory, account for individual and team-level per-
Future work should continue to evaluate the formance, capture team process and outcomes,
selection, upskilling, timing, duration, and impact adhere to standards for reliability and validity,
of sustainability of team training. This includes and address real or perceived barriers to measure-
evaluating the impact of team training on patient ment. The interdisciplinary nature of work in the
safety outcomes, evaluating team training in perioperative environment and the necessity of
other settings (e.g., emergency department, out- cooperation among the team members play an
patient surgical care settings), examining the important role in enabling patient safety and
comparative effectiveness of different methods avoiding errors. Training team leaders and surgi-
for delivering team training, and examining cal teams in this manner will lead to better satis-
implementation methods to support sustaining faction, joy at work, and reduced burnout of
behavior changes achieved through training. For surgical team members.
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Promoting Occupational Wellness
and Combating Professional 14
Burnout in the Surgical Workforce
Ross M. Ungerleider, Jamie Dickey Ungerleider,
and Graham D. Ungerleider
“It matters that life lives through you.”

—Roger Keyes
Hokusai says look carefully. He says it doesn’t matter if you draw, or write
He says pay attention, books. It doesn’t matter if you saw wood, or catch
notice. fish. It doesn’t matter if you sit at home and stare at
He says keep looking, the ants on your veranda or the shadows of the
stay curious. trees and grasses in your garden.
Hokusai says there is no end to seeing. It matters that you care.
He says look forward to getting old. It matters that you feel.
He says keep changing, you just get more who you It matters that you notice.
really are. It matters that life lives through you.
He says get stuck, accept it, repeat yourself as long Contentment is life living through you.
as it is interesting. Joy is life living through you.
He says keep doing what you love. Satisfaction and strength is life living through you.
He says keep praying. He says don’t be afraid. Don’t be afraid.
He says every one of us is a child, every one of us Love, feel, let life take you by the hand.
is ancient, every one of us has a body. Let life live through you.
He says every one of us is frightened. —Roger Keyes
He says every one of us has to find a way to live
with fear. The following is from a Wikipedia page:
He says everything is alive—shells, buildings,
Jonathan Drummond-Webb (29 August 1959–26
people, fish, mountains, trees, wood is alive. Water
December 2004) was a South African pediatric
is alive. Everything has its own life. Everything
heart surgeon. He committed suicide. His suicide
lives inside us.
note indicated professional frustration may have
He says live with the world inside you.
been a factor in his death.
The following is from a The Chicago Sun

Times (July 3, 2010):
A (pediatric cardiac) surgeon apparently shot his
wife and killed himself Friday, a month after she
R.M. Ungerleider, MD, MBA (*) filed for divorce and sought an order of protection
Department of Surgery, Brenner Children’s Hospital, against him, according to police and court records.
Wake Forest Baptist Health, Dr. Hani Hennein, 52, was found dead of a self-
Med Center Blvd, Ardmore Tower, 10th Floor, inflicted gunshot wound at the family home in the
Winston Salem, NC 27157, USA 700 block of South Hillside Avenue just after
e-mail: [email protected] 7 a.m., police said.
J.D. Ungerleider, MSW, PhD • G.D. Ungerleider The following are from stories relayed to us (names
Wake Forest University School of Medicine, withheld and details altered to obscure identities):
431 Riverbend Drive, Advance, NC 27006, USA
e-mail: [email protected]; I’ve been a pediatric cardiologist for 26 years and
[email protected] I’m nearing what should be the most rewarding

206 R.M. Ungerleider et al.
part of my life, but I’ve never been more depressed. they show up at all. Burnout and distress contrib-
Our children are grown and my wife and I find that
ute to absenteeism, which in its most severe form
we have little in common. I feel angry all the time.
I’m overweight, out of shape and on a statin. I’m can lead to suicide.
not sure what has happened to my life. Given this sobering introduction, it might be
Or attractive to change the title of Willie Nelson’s
I was on call the night my mother called me to tell
famous song to “Mommas, don’t let your babies
me my grandfather had died. She had called sev-
eral times during the past hour, but I was busy and grow up to be doctors.” In the pages that follow,
ignored the calls. When I had a break I called her we will provide a brief overview of the current
back. That’s when she told me the news and I state of this problem and its implications for both
snapped back a response: “Mom, I’m on call. I’m
safety and quality. More importantly, we will also
busy. I can’t deal with that right now and I have call
this weekend, too. I can’t get away. I can’t come make suggestions that we hope will help you,
for the funeral.” That was 13 years ago. My grand- personally, find protection, recovery, and, quite
father was one of the most important people in my possibly, renewal for your dreams.
life and I didn’t go to his funeral because I didn’t
Physician distress is not a “new” problem.
think that I had enough control over my life to tell
my boss that I had to go. I still regret that. Every Articles describing “burnout” among physicians,
day. I regret the kind of person I was becoming. I nurses, and even hospital administrators began
hope my grandfather up there understands. I hope appearing in the late 1970s [1–4]. A quick search
someday I will understand. Right now, I just feel
of medical database publications indicates that
really sad that I let that happen.
the appearance of literature related to burnout is
The following could be you: doubling every decade. Although there were only
I remember the day I got into medical school and it a handful (less than 100) of articles on burnout in
was one of the most exciting days in my life. My the 1970s, there were close to 1000 (776) in the
life was so unencumbered back then. Now I just 1980s; over 2000 in the 1990s (2041); and over
feel overwhelmed. My work no longer gives me 4000 (4092) in the first decade of this century and
joy—it feels like a burden—an obligation. I don’t
have any time for myself. I have trouble keeping up halfway through the current decade there have
with my friends. It seems I have to work harder been 3418 referenced papers related simply to
(for less) and between the increasing demands of burnout—predicting over 7000 publications on
my practice, my family and trying to pay off my burnout alone in the decade between 2011 and
education debt I feel like I’m barely making it. I’m
not living my life. I’m enduring my life. 2020. If the search is expanded to include topic
titles such as depression, suicide, marital distress,
How does this happen? It’s not a part of the
dream we had as we entered the profession of med-
compassion fatigue, and substance abuse among
icine. But somewhere in between the excitement of physicians, and even the more hopeful title of
that early dream and the poignancy of the stories wellness, the amount of published material is
above is the reality that many of our colleagues overwhelming. This has become an issue of
find themselves experiencing.
global warming proportions!
In 2008, the American College of Surgeons
(ACS) Committee on Physician Health and
Burnout and Distress Competency conducted a survey of its member-
ship using a validated instrument for burnout,
The literature on burnout and distress in today’s quality of life (QOL), and career satisfaction. The
physicians is disturbing. Over the past decade, sample size was a staggering 7905 surgeons.
articles have begun to avalanche into the medical, Collectively, 40 % of surgeons met the criteria for
business, and social sciences literature about pro- burnout, 30 % screened positive for depression,
fessional “burnout.” Highly trained profession- and 28 % had a mental QOL score at least ½ stan-
als, in what should be the prime of their personal dard deviation below that of the US population
and professional lives, are showing up depressed, [5, 6]. Younger surgeons (our future) and those
anxious, depersonalized, addicted, divorced, and with children between the ages of 5 and 21 were
disillusioned and in various states of disease. If a higher risk as were surgeons whose compensa-
14 Promoting Occupational Wellness and Combating Professional Burnout in the Surgical Workforce 207
tion was based entirely on billing/productivity, who are close to them. Few, if any, medical
and those who spent more nights on call per schools do a credible job of teaching wellness
week. There is an increasing body of evidence skills such as meditation, perspective-taking (a
that burnout, and its related distress factors, can method of valuing the perspective of another as a
have a significant adverse effect on patient safety credible part of the “truth”), self-compassion,
and quality of patient care, and even contribute to stress/self awareness, stress/self management, or
medical errors [5, 7–11]. other forms of self-care, leadership, and personal
Although burnout and related forms of dis- growth. Physicians are taught to be “knowers”
tress (a sense of feeling overwhelmed and of low (they are tested for “knowing” and not for skills
accomplishment, anxiety, depression, deperson- such as willingness to learn, persevere, or think
alization, and health issues related to stress) may differently), and as such they are constantly hard
likely occur in many professions, it does appear on themselves and on their colleagues who might
that healthcare professionals are particularly vul- let them down. This is not really an issue of bal-
nerable, and women may be more susceptible ance as much as it is one of values [14].
than men [12]. Medicine attracts a diverse group Burnout was previously thought to be a late
of individuals, some of whom are genuinely career phenomenon, but more recent studies sug-
altruistic (meaning they value placing the needs gest that young physicians today have nearly
of others above their own), while others have twice the incidence of burnout compared with
self-serving altruism (meaning they need to feel their older colleagues [15]. One recent review
that they have helped others in order to feel good looking at physician satisfaction and burnout at
about themselves). Students applying to medical different career stages [16] suggests that mid
schools are often high achievers, ambitious, com- career appears to be a particularly challenging
petitive, idealistic, and perfectionistic (a combi- time for physicians. However, early career is also
nation that leads to high expectations and a loud a risk period and the appearance of burnout and
internal (and sometimes external) “critical” voice related distress syndromes has been described in
when results are less than desired). Many physi- resident physicians [17–21] and more recently in
cians are by nature comfortable with a life of medical students [22–29]. One explanation for
“delayed gratification” that can contribute to a this might be in the enlightening research from
“suffer now to reap eventual rewards” mentality. Robert Sapolsky who has studied the response of
In our own (now close to 20 years of) work with primates to hierarchical stress. Primates with less
physician and other healthcare professional cli- influence in decisions tend to have the higher
ents, we have noticed the consistency with which level of stress-related cortisol and are more likely
they value teachers or colleagues who “are to withdraw from social interaction. This not
always in the hospital,” who “don’t ever seem to only helps us understand why younger physi-
go home—they are here 7 days a week,” or who cians who generally are lower in the hierarchy
“spend their time writing, teaching and achieving experience burnout and distress from feeling
recognition” beyond what their “normal” col- helpless and having no power, but it might also
leagues do. The type of “role modeling” described help us understand why physicians in general are
above may be detrimental in the long run, as now becoming despondent as they begin to feel
noted by some well-known experts in the field of disenfranchised from healthcare policy decisions
physician well-being, who suggest that these that affect their lives as well as how they are told
“heroes (of our young, emerging healthcare to practice medicine [30]. Other evidence points
workforce) lead lives that are desperately out of to burn-out contributing to acting out in unpro-
balance” [13]. Ultimately, this creates the sad fessional and disruptive manner in and around
irony that the physicians who are respected for the operating room [31]. Furthermore, these pres-
their responsibility to care for others are the ones sures can have a lasting effect on technical and
who seem to most neglect themselves and those non technical aspects of patient care [32].
Beginning in 2012, we began collecting longi- for only a couple of months, we begin recording
tudinal data related to burnout and distress in stu- increasing levels of depression, depersonaliza-
dents enrolled at Wake Forest University School tion, and a sense of feeling overwhelmed. What
of Medicine. We now have 4 years of data and the is particularly notable about the data on our stu-
only longitudinal data of medical student distress dents is the periodic effect of life events on their
that we know of. Previous studies on medical stu- well-being. Although most distress elements
dent, resident, or physician distress have been seem to diminish during breaks and then increase
generated from single time frame evaluations of during times of stress—such as around the time
the study population. Under IRB approval, we of preparation for the ABMLE step exams
obtained information pertaining to burnout and (1 >
2)—depersonalization (question # 2 in
distress using the Medical Student Well-Being Fig. 14.1) does not diminish and continues to
Index (MSWBI) [24]—a validated instrument for increase throughout medical education. This sug-
evaluating burnout, anxiety, depersonalization, a gests that once depersonalized, students remain
sense of feeling overwhelmed, fatigue, and depersonalized, although anxiety, depression,
stress-related health issues. We surveyed all med- and a feeling of being overwhelmed may vary
ical students in every class for 4 years at various depending on other life events. By the time the
periods during their medical education. Our students reach their fourth year, almost half
results were remarkably similar from class to (44 %) are depersonalized. As a whole, males are
class and composite data are displayed in also more likely than females to feel depersonal-
Fig. 14.1. Figure 14.2 displays the rising inci- ized (26 % vs. 21 %; z value = 2.72) and less likely
dence of burnout and “near burnout” as medical to feel depressed (22 % vs. 34 %; z-value = 5.2),
students progress through their education at overwhelmed (24 % vs. 35 %; z-value = 4.9), or
Wake Forest University School of Medicine. anxious (37 % vs. 58 %; z-value 8.6) as they pro-
Our findings indicated that except for anxiety ceed through medical school. In addition,
(approximately 30 % of students at orientation Caucasian (nonminority) students are less likely
report feeling anxious), students begin medical than non-Caucasian (minority) students to
school with a low level of other distress elements. become depersonalized (23 % vs. 29 %; z
However, by the time they have been in school value = 2.2), and are less likely to feel depressed
Fig. 14.1 % Positive responses over time by MSWBI (EE), question 2—depersonalization (DP), question 3—
question (composite of all classes). Percentage (vertical depression (DEP), question 4—fatigue (FT), question 5—
axis) of positive (“yes”) responses to each MSWBI ques- sense of feeling overwhelmed (OVRW), question
tion for all students grouped by collection period (hori- 6—anxiety (ANX), and question 7—major stress-related
zontal axis). Question 1 measures emotional exhaustion health impairments (HEALTH)
Fig. 14.2 % At risk (3 positive responses) and burnout tive response to MSWBI questions on an individual sur-
(≥4 positive responses) over time (composite of all vey and burnout defined as ≥4 positive answers to
classes). Percentage of students (for each collection MSWBI questions. Proportions for burnout were calcu-
period) who are “burned out” or “approaching burnout” lated as total number of yes responses out of seven on a
and consequently “at risk” for serious burnout-related given survey rather than using question-specific
consequences (health impairments, dropping out of parameters
school, suicidal ideation, etc.). “At risk” defined as 3 posi-
(27 % vs. 36 %; z-value 2.89) or overwhelmed Students who provide ≥4 positive answers to
(28 % vs. 34 %; z-value 2.2) as they proceed the questions in the MSWBI meet the criteria for
through medical school. burnout as described in the literature. Previous
Depersonalization invites more than lack of studies have suggested that once someone has
empathy. Depersonalization can contribute to provided a score of 4 or more positive answers,
lack of conscience (with implications for profes- they are also at risk (“15-fold compared to stu-
sional integrity), lack of the ability to perform dents with no distress conditions”) [23] for seri-
self-reflection (a critical quality for leadership ous thoughts of dropping out of medical school
and creating emotionally intelligent relation- [23, 35], having suicidal ideation [23, 25, 27, 28,
ships), lack of imagination, energy, intuition, and 36], poor mental quality of life [35], or high
moral imperative. This can lead to problems in fatigue [26, 33]. In our study, we also considered
building trust, working effectively with others, students with at least three positive answers to be
being skillful in action, and in managing moods an “at-risk” group for burnout. Using this defini-
and emotions—all qualities essential for safe and tion, almost half (46 %—combining those stu-
effective healthcare delivery. In a study of burn- dents who are either “burned out” or “at risk for
out and medical errors among American sur- burnout”) of our students seem to be at risk for
geons, Shanafelt et al. [7] found that whereas a major negative life events by the time they begin
one-point increase in emotional exhaustion their fourth year of school (Fig. 14.2).
resulted in a 5 % increase in the likelihood of The implications of this study are evident.
reporting a medical error, a one-point increase in Medical school literally makes people sick. They
depersonalization resulted in an 11 % increase of don’t come in sick, but by the time they near
reporting a medical error. There is ample evi- completion of their studies they have experienced
dence that feelings of depersonalization are asso- progressive emotional exhaustion, depersonali-
ciated with the risk of non-empathic and morally zation, depression, anxiety, irritability, and a
suspect behaviors, as well as with physical, emo- sense of being overwhelmed. One out of ten stu-
tional, and mental problems [33, 34]. dents report that they have developed stress-
related impairments to their health—a problem create for ourselves a personal culture of well-
that is virtually absent when they begin school. ness. Wellness entails much more than the
Burnout and distress have a negative impact on absence of burnout. That would be like defining
quality of life, and both appear and increase inex- health as the absence of disease [39]. Wellness
orably throughout medical school. embodies energy and vitality. Wellness embraces
These are new, but not surprising data, which joy and playfulness. Wellness promotes resil-
indicate that the conditions that result in burnout ience, learning, self-compassion, creativity, and
and distress occur prior to becoming a doctor, and relationship. Wellness requires a healthy mind,
therefore we believe that they should be urgently body, and heart—and the behaviors consistent
addressed during medical training, across the entire with those. Wellness encompasses all the impor-
spectrum of healthcare. Einstein once famously tant aspects of our lives and exists in numerous
stated “you can’t solve a problem with the same dimensions, including mental, physical, emo-
minds that created it.” We would add that you can’t tional, spiritual, and relational. This section will
solve a problem that you can’t/won’t acknowledge. discuss basic tenets of wellness and suggest ways
Unfortunately, it has been our experience that when that might help you better manage the demands
the very medical leaders who can influence change of your professional life [40].
are presented with these data, they either diminish Medical centers, hospitals, and practices have
or normalize the importance of the information, or become increasingly aware of the challenges their
claim that this is simply pervasive and not some- healthcare workers face, and this has led to
thing they can change, (perhaps due to their own increased efforts to prevent burnout. Some pro-
depersonalization and burnout?) In the early 2000s grams have instituted wellness programs [39],
the ACGME (Accreditation Council for Graduate including coaching, opportunities for encourag-
Medical Education) initiated the Outcomes Project ing and promoting physical exercise (the
that introduced the requirement that physicians Cleveland Clinic provides pedometers to all
become competent in a variety of areas beyond employees and encourages them to take 10,000
medical knowledge and patient care—ironically steps/day—a virtual impossibility for surgeons
this was implemented as a method to cultivate who stand in one place for extended periods of
patient-centered care, reduce medical error, and time), stress management training, and other sup-
move healthcare towards a system that was “safe, port systems [39, 41, 42]. Many medical centers
equitable, efficient, timely, and equitable” [37, 38]. are changing their cafeterias to environments ded-
These competencies, as they were termed, included icated to healthier eating with more transparent
professionalism which required that residents dem- nutritional information and some have gone so far
onstrate “responsiveness to patient needs that as to remove unhealthy items (such as fried foods
supersedes self interest” [39]. This is the conun- or foods with high sugar content) entirely from
drum to which healthcare providers are held their campus. Others have suggested that wellness
accountable. How can they take care of themselves become a quality indicator against which to mea-
when there is always a sick patient in need of atten- sure the successfulness of our organizations [43].
tion that would supersede one’s own needs? Of Despite these efforts, a human dilemma continues
course the patient should always “come first.” And to plague healthcare professionals when they are
we would remind you, “so should you.” In the asked (either directly or indirectly) to strictly
remainder of this chapter, we will suggest ways adhere to the belief that professionalism requires
that this can be possible. placing the patients’ needs above one’s own
needs—creating the unintended consequence of
perpetuating a culture of self-denial (food, rest,
Wellness basic hygiene, self-care) leading to burnout,
depression, depersonalization, and unresolved
If our current medical culture promotes burnout stress with resultant manifestations for our health
and distress, then it becomes incumbent upon and even for our survival. The reality is that we
each of us to take back control of our lives and are not “limitless resources” [44]. This dilemma
summons the challenge of crafting systems of much more productive we could all be, we began
abundance and inclusion that allow for both care our talk with a story about time management as
of patients and caring for the caretakers—our- we see it. If you take a large jar and fill it with
selves. In recent years, this has spawned a prepon- some big river rocks, is it full? “Of course not,”
derance of literature addressing concepts of replied this now well-attuned audience. All right
work–life balance—a curious term since it invites then, what if we then took scoops of pebbles and
us to think that there might be a magical and static poured them into the jar to fill those spaces
formula that will protect both us and our careers between the rocks. Is the jar full? “No,” replied
from unraveling into a loosely recognizable jum- the audience. There is still space. So, what if we
ble of our dreams and hopes. then sifted in a bunch of sand and gently shook
Work–life balance is not possible. There is no the jar to make certain it invaded whatever space
formula that will create a balanced life that fits is left. Is it full? “No.” Apparently the previous
for all of us. Life is challenging, sometimes speaker had made quite an impression. Well, what
messy, and potentially invigorating. if we now fill the jar with water. Is it full? “Yes,”
Decisions about managing the demands of sighed the audience. “We believe you have now
work and life require choice [14, 40]. How we filled the jar.” So, we asked, what is the point of
understand and manage our process for making all this. Our time management guru, who was still
choices contributes to our ability to be “well.” In in the audience, blurted out the obvious: “Just
the sections below, we provide an overview of what I was mentioning. You can get a lot more
some important research that relate to creating a into your day than you imagine.” Well, we replied,
life of intra- and interpersonal wellness. We then that would seem to be the case. We offer another
offer a few suggestions that may help you begin thought that we would like you to consider: If you
this journey. don’t get those big rocks in first, you’ll never get
them in later. Those big rocks are the secret for
being intentional. They are the core elements of
Research Behind Wellness your life. If you lose touch with them, you will
lose your foothold on the foundation that can sup-
Flexibility and Congruence: Choice becomes port and balance your life.
more consistent with wellness (our physical, Achieving balance in professional life has been
mental, emotional, spiritual, and relational well- a hot topic in the past few years at many medical
ness) when it remains connected to our values. meetings. We are frequently asked to speak about
We described this in an article we published sev- this, and we are often in the audience as others
eral years ago, and we have reproduced part of give their views on the subject. Balance, contrary
that article below [40]: to the opinions of some, is not about creating equal
We were once asked to give a talk to a large parts of work and time with the family. Balance is
group of surgeons on how to create a balanced about choice. “Who are you and what do you
life. We followed an expert in time management. want?” These seem like such simple questions, but
His talk comprised an informative sequence of many of us go our entire life and never answer
slides that provided advice on how to be orga- either. The numbing and insatiable addiction to the
nized and efficient from the time you got up in the external validation that comes from performance
morning until you went to bed at night. The audi- recognition can have us lose sight of ourselves.
ence was busy writing notes on every bulleted Begin to believe that you are defined by your per-
point. So were we. Here was a lecture full of use- formance, and at some point in your life, you may,
ful information. We would never again have an having travelled far from who you are and the
excuse for failing to get our tasks done. And we dreams that you held for yourself, become focused
would be able to expect the same efficiency from solely on the performance required for the next
others. What a wonderful prescription for success. award. It’s as if you set out to be some thing, and
With the audience now fully cognizant of how you forgot how to be some one.
There is a classic scene in the movie City for emotional intelligence and many other
Slickers, with Billy Crystal and Jack Palance. important leadership and life management strat-
Palance plays the part of Curly, a wizened cow- egies [48–53]. In order to become skillful in this
boy who takes middle-aged business men on practice, it is critical to develop unflinching
cattle drives to help them get away from the cri- self-awareness, empathic openness to others,
ses of their lives. Billy Crystal (Mitch) is strug- and an ability to be curious, open, and able to
gling with how to handle numerous stresses in his accept without judgment, but rather with the
life and he is riding alongside Curly when he gets ability to simply love what is present (COAL)
a famous dose of Curly’s wisdom. [54–56]. Physicians are acculturated to “know”
answers which leads them typically to judge
(triage, evaluate, interrogate or criticize) and to
take action (cure, treat, offer expert advice, or
Curly: “Mitch, How old are you? 38?”
fix something) much more than they are taught
Mitch: “39.”
to be curious (to “not know”) and simply notice,
Curly: “Yeah, you all come up here about
or explore to understand by asking (without
the same age. Same problems. Spend
interrogating and by exposing the vulnerability
about 50 weeks a year getting knots in
of a “beginner’s mind”) [57–59].
your rope and then you think 2 weeks up
Developing a sense of self is perhaps the most
here will untie them for you. None of you
challenging skill for a physician and yet without
get it. (Pause. They stop riding and just
developing this, wellness is elusive. We are not
look at each other. CURLY continues).
talking here about the “aggrandized sense of
You know what the secret of life is?”
self” that is often wrapped up in the protected
Mitch: “No. What?”
cocoon of grandiosity from our acclaim or
Curly: “This.” (He holds up his index
achievements, but rather the genuine sense of
finger.)
self that sees and accepts all of our self-aspects
Mitch: (Trying to be funny, and dismissive
including our limitations, mistakes, and longings
of his feelings) “Your finger?”
without shame and with compassion and love
Curly: “One thing. Just one thing. You stick
[60, 61]. It’s that part of us that may keep us
to that, everything else don’t mean s**t.”
awake at three in the morning wondering how
Mitch: “That’s great, but what’s the one
our life took the path we now find ourselves on.
thing?”
That sense of self is authentic and it needs to be
Curly: “That’s what you gotta figure out.”
listened to [62]. It is through attuning to your
own voice that you will be able to find and stay
on your path to wellness.
That “one thing” might be to figure out your Our most current thinking about work and life
big rocks, those things that give your life a mean- is what we term, Work Life Flexibility and
ingfulness that you feel somewhere in the middle Adaptability, and is illuminated in a story we pub-
of you. And make choices with them in mind. lished many years ago (when the field around us
Articles by us, and others, have described the still tried to encourage the concept of balance) and
dynamic and often competing energy between we were struggling with better ways to teach skills
the needs (hopes, wishes, demands) of ourselves for achieving something that looks like balance
(our own deep wants that we have frequently but that feels much more congruent with honoring
been taught to suppress as irrelevant), others the needs of self, other, and context [14]. Congruent
(with whom we are in relationship—either at decision making invites and encourages us to stay
home or at work), and our context (the current present and attuned as we explore and hold in
situation, environment, professional expecta- regard the complexity of competing and divergent
tion, etc.) [14, 45–47]. This ability to be aware needs. The consequences of ignoring this informa-
of the needs of self, other, and context and then tion, or suppressing it as irrelevant, enhance the
to be able to manage these needs forms the basis likelihood of living with continually unmet needs
which is a major contributing factor to burnout and I ntegration and the Window

distress [45–47, 58, 63, 64]. When we achieve a of Tolerance
sense of congruence, our choices invite us to have
greater compassion for the difficulty of what we In our work with numerous professionals,
do. This story (and others) [14, 40] has helped including many in highly stressful healthcare
numerous colleagues understand the competing endeavors, a common theme we have observed
variables that must all be valued and honored in among those who are in distress or who are
order to make choices that remain connected to the burned out has been lack of integration. We view
delicate essence of our lives—choices that respond integration as an essential skill for achieving
to what is happening in the now, and that don’t get wellness.
stuck repeating tired patterns that may not serve us Integration is the ability to link differentiated
well any longer. parts into a whole that is flexible, adaptive,
In an address to the International Conference coherent, energized, and stable (FACES) [56,
on Communication in Healthcare [44], Charles 58]. You might want to imagine integration as a
Hatem suggests that attentiveness to wellness can river (as portrayed so elegantly by Dan Siegel)
lead to renewal. Renewal is a hopeful term; and [56]. The river (which symbolizes your life) is
that is appropriate because hope is a key ingredi- constantly flowing past two banks. On the left
ent for change. Renewal invites us to return to our bank is rigidity and on the right bank is chaos—
self, which can be daunting to healthcare workers neither is an integrated or desirable bank to rest
who have been taught to ignore their own needs. on. In order to stay in the river (of integration),
This invitation to return to our self brings to mind one must avoid becoming overly differentiated
the prophetic words of T.S. Elliot: (not allowing the feelings, opinions, or informa-
We shall not cease from exploration, tion from others to influence us)—which leads
And the end of all our exploring to chaos (imagine if your family or team was
Will be to arrive comprised of people who were totally differen-
Where we started tiated and unable to take any influence from
And know the place for the first time.
(link to) each other—theirs was the only opin-
Often referred to as the poet laureate for cor- ion or knowledge that counted—it would be
porate America, David Whyte once wrote [65]: chaos). On the other bank is rigidity, which is
In effect, if we can see the path ahead laid out for us, the result of too much linkage—where people
There is a good chance it is not our path; “fuse” in their beliefs (such as creating proto-
It is probably someone else’s we have substituted cols and policies that apply to all and from
for our own. which there is no room for differentiation). In
Our own path must be deciphered every step of the
way. our healthcare culture, we have been encour-
aged to link to the point of rigidity and deviation
In healthcare, we have been taught to pay (including introduction of wellness programs) is
attention to the needs of others and to the considered irrelevant, at best; and disruptive at
demands of the context, but returning to the worst. When that culture becomes pervasive, we
sanctity of the self is an important theme in the have become grounded on a riverbank and are
“hero’s journey” that many professionals com- no longer able to value differentiated parts.
plete during the course of their career [62]. It is FACES reminds us that to stay in the river, we
a journey of spiritual awakening among physi- need to adopt the seemingly paradoxical abil-
cians, and it is the journey that leads to well- ity to be flexible yet stable [58]. To do this
ness. In this sense, spirituality is defined as the requires we (1) adapt to what is happening
reality of our commitment to a larger set of tran- now (within (self), among (others), and
scendent values as a framework for what we do, between (context)) and treat that information
and properly acknowledged and incorporated, with coherence (harmonious connection of
this becomes a key part of the front-wheel drive equally valuable parts) while appreciating the
in our lives [44, 62, 66]. energy available to us with this awareness.
These skills empower us to consider emerging Table 14.1 Mechanical vs. complex adaptive systems
possibilities and free us to make choices that Mechanical system Complex adaptive system
remain stable (connected to our values and goals) Predictable, routine Unpredictable, variable
while allowing infinite flexibility (potential for Task orientation—valuing Relationship
creativity and non-automaticity). of consistency and orientation—valuing of
checklists differences
If the river of integration symbolizes our jour-
Emergent behavior Emergent behavior
ney through life, obstacles that float towards us
discouraged encouraged
create challenges to which we have a variety of Interrogate, judge, fix Explore, understand, join
responses. On some occasions those challenges Spreadsheets, charts, Collaboration,
become intolerable and we react. One way of graphs, protocols to connection, and
reacting is to fight (akin to throwing an instru- enhance or measure inquisitiveness to
ment, or yelling at someone) or flee (we simply reproducibility and enhance or stimulate
comparability change and growth
leave—perhaps saying who needs to put up with
One correct answer Multiple possibilities
this anymore, I deserve better). Another way that (truth)
we react to a challenge, when it becomes intoler- Linear thinking Systems thinking
able, is we freeze or collapse (simply disengage
or shutdown). This would be similar to avoiding
a conflict or even deciding to quit a job—get a In their first report, To Err is Human (pub-
divorce. Each of us has a window of tolerance lished in 1999) [37], the Institute of Medicine
that we can notice. Our window of tolerance may (IOM) called attention to the difference between
be big for some people or circumstances, and mechanical and complex adaptive systems. Not
very small for other people or circumstances. only is it important to understand this difference
When we get outside our window of tolerance as it relates to patient safety, but it is also criti-
(as manifested by fight, flee, freeze, or with- cally relevant to your own safety and wellness.
draw), it is an opportunity to learn and be curious Table 14.1 compares some of the important
(remember COAL). We insert this to remind you characteristics of each. Mechanical systems are
of the advice from Hokusai (see beginning expected to perform in a predictable and routine
quotes) because the path to wellness doesn’t fashion. An elevator, car, airplane, or heart lung
require perfection; it only requires presence, machine is a mechanical system. When you
including that you simply notice. Life, living push the button for the fifth floor in an elevator,
through you, restores the ability to notice, and depress the accelerator on a car, pull back the
use that awareness to treat yourself as one of throttle in an airplane, or turn up the speed of a
your own best friends. roller head on a pump, you anticipate a predict-
able result. You don’t just anticipate it, you
expect or even demand it. If you don’t get that
echanical vs. Complex Adaptive
M result, you might declare the system to be “bro-
Systems ken” and in need of repair, and a repairperson
would come and interrogate (analyze), judge
As mentioned in the earlier section on burnout (declare the nature of the problem), and fix the
and distress, our cultural demand for perfection- malfunction. Mechanical systems lend them-
ism and our resultant shame when we can’t selves to task orientation and protocols [67].
achieve that impossible goal are factors that con- Emergent (creative or innovative deviations
tribute to our inability to be well. Lack of under- from protocols) behavior is simply discouraged.
standing on the part of healthcare professionals You wouldn’t want to push the button on an ele-
and leaders in distinguishing the difference vator for the fifth floor and have it take you
between mechanical and complex adaptive (bio- instead to the third floor because that has been
logical) systems perpetuates and exacerbates this the more popular floor today. Mechanical sys-
problem. tems work because of consistency—there is one
correct answer—and it is in the owner’s m anual. In medicine, we work with both mechanical
Mechanical systems lend themselves to charts and complex adaptive systems simultaneously. It
and graphs for measuring results because all the is important that we don’t get them confused.
systems are the same and are comparable. All of the above information informs ways we
Mechanical systems are robotic, not human. can choose to utilize for constructing our lives. In
How would you like to be interrogated, judged, the section that follows we will offer numerous
and fixed? Unfortunately, our medical culture ways for you to recover and renew—which tech-
often tries to do this to us. No wonder we niques you choose will be a matter of personal fit
become unwell. and comfort.
Complex adaptive systems are unpredictable
and variable. We hope for a certain range of per-
formance and when we don’t get what we desire, The Healthy Mind Platter
our approach is more often to explore (with genu-
ine, open-minded curiosity) in order to under- In 2012, David Rock, Dan Siegel, and colleagues
stand (learn) so that we can join (connect to) the introduced the concept of the healthy mind plat-
system in a way that can help us better manage ter [71] (see Fig. 14.3), based on substantial
future relationships to it. Farming is an example research in the fields of physiology, neurology,
of a complex adaptive system. The farmer can biology, business, and medicine. These seven
learn all they can about the characteristics of the neurocognitive activities nurture the mind, the
soil, the climate, and other factors that would body, the brain, and our spirit, reconnecting us to
guide them to plant a certain type of crop, and our wholeness and allowing us to renew. Below,
then they have to watch and see what happens. If the items on the platter are briefly described,
they don’t get a desirable result, it won’t help using information and segments from Rock and
them to blame the weather, criticize the soil, or Siegel’s important article.
punish the seeds. They are better served by trying
to understand what happened and how this might Sleep Time
influence what they do the next year. They might Research has shown that sleep is critical for
decide to try something that others in the area homeostatic restoration, thermoregulation, tis-
haven’t tried and this could lead to a remarkable sue repair, immunity, memory processing and
outcome. Errors are understood as opportunities consolidation, learning, and emotion regulation.
to learn rather than failures that create shame Increasing evidence about noisy and disruptive
[68]. How many of you would like to be explored alarms contribute to disrupted sleep by physi-
with genuine curiosity in order to be understood cians, to altered physiological vital signs, ele-
so that your ideas and energy can be connected in vated levels of stress and medical errors [72,
a meaningful and appreciated way to the energy 73]. Accordingly, sleep deprivation can be more
of your group? Complex adaptive systems thrive lethal than food deprivation. Belief that you are
on this type of emergent (innovative) behavior a mechanical system that doesn’t require sleep
for change and growth, and these systems invite is not a path to wellness. Recent studies strongly
multiple possibilities or solutions—they are life point to the fact that sleep is far more important
enhancing, not life restricting. In fact, research than is generally recognized, and though people
has suggested that one of the most powerful in general (and in healthcare specifically) don’t
behaviors for creating vibrant and resonant rela- get enough of it, there are easy steps to start
tionships and teams is the ability of people to remedying this problem. Adding a nap to one’s
accept influence from one another, regardless of day or an extra 20 min to one’s sleep cycle (or
their title or position in the hierarchy [30, 69, 70]. both) can yield major benefits to cognition,
Complex adaptive systems are human and wel- emotional regulation, and general performance
come all that comes with that—including, and for the complex adaptive system called by your
perhaps requiring, wellness. name.
Fig. 14.3 The healthy mind platter
Play Time humans to practice the novel motor and social

Playfulness enhances our capacity to innovate, skills that will prove to be essential for survival
adapt, and master changing circumstance. In in the workplace jungle.
this sense, playfulness is a way to expand our
windows of tolerance and improve our capacity Downtime
to be flexible, adaptive, coherent, energized, and This is the most counterintuitive component of
stable. It is not just an escape. Play can help us the healthy mind platter, and possibly the most
integrate and reconcile difficult or contradictory misunderstood. It is also extremely challenging
circumstances. And, often, it can show us a way for most people in the healthcare profession.
out of our problems. All mammals play; yet it is Downtime does not refer to hobbies (focus time)
ironic how our healthcare culture suppresses or sports (physical time) but rather to a very spe-
that, because what we do, after all, is “serious cific activity: “inactivity,” or “doing nothing that
business.” It turns out that play is also “serious has a predefined goal.” Downtime is actually
business” [71]. Numerous studies have docu- intentionally having no intention, of consciously
mented the impact of positive emotions on team engaging in doing nothing specific. Downtime is
and individual performance [69, 74–77] and simply “hanging out, being with one’s surround-
play invites positive emotions, which have been ings, being spontaneous, having no particular
documented as being critical for optimal perfor- goal or focus.” Unfortunately, most of the words
mance [69, 74–76]. Equally important benefits used by busy/successful professionals to describe
of play is that it can facilitate learning and play downtime have a negative connotation—words
can help in the development of flexible emo- like idling, hanging around, loafing, lazing, goof-
tional responses to unexpected events (our win- ing off, and chilling out. During downtime, we do
dow of tolerance) where individuals experience much more than slumber, rest, and go “off-line.”
a loss of control, and which can be a major form Researchers have shown that insight is preceded
of stress [30, 71, 78]. Play, or “having fun,” is and aided by disconnecting from deliberate, goal-
not healthy when it is structured to tease, belit- directed, conscious thinking and permits the pro-
tle, or in any way deride a team member [58], cess of integration, or the linking of differentiated
but in its pure and spontaneous form, it allows parts, to unfold. Numerous studies have demon-
strated the superiority of unconscious thought vs. dividends in maintaining a healthy physiological
conscious, logical reasoning in creating clearer, and psychological state. Unlike time-out, time-in
and more innovative decisions [79, 80]. In their is time spent paying attention in a particular way,
book The Break-out Principle [81], Herbert on purpose, in the present moment. Many medi-
Benson and William Proctor explain that the best cal schools are now including mindfulness medi-
way for solving thorny issues or complex prob- tation practices as a part of their curriculum in an
lems is first to struggle with it, through problem attempt to enhance wellness. There are a variety
analysis or fact gathering, up to the point where of ways to introduce mindfulness and awareness
one stops feeling productive and starts feeling as an antidote to the automaticity of your life and
anxious and stressed. This is the signal for the these include mindful meditation techniques,
second step: “distracting” oneself from the prob- reflective journaling, or other awareness-inviting
lem. There are many ways of doing this, includ- practices. For more information on some of these
ing visiting a museum, taking a hot shower, you may wish to visit the following websites:
listening to some calming music, or going for a
walk. According to the authors, the key is “to http://ggia.berkeley.edu/practice/expressive_
stop analyzing, surrender control, and completely writing?utm_source=GG+Newsletter+Feb+17
detach (oneself) from the stress producing +2016&utm_campaign=GG+Newsletter+Feb+
thoughts.” This typically leads to what the authors 17+2016&utm_medium=email#data-tab-how
call “the breakout”: a sudden insight or a new (Greater Good at Berkley and J.W. Pennebaker,
perspective that sheds a whole new light on the PhD)
problem at hand. The very fact that unconscious http://homepage.psy.utexas.edu/homepage/fac-
thought and incubation time are conducive to bet- ulty/pennebaker/home2000/WritingandHealth.
ter decision making and insight has profound html (JW Pennebaker, PhD)
implications for self-leadership. Downtime con- http://www.drdansiegel.com/resources/wheel_
nects the left brain’s clutter of facts with the right of_awareness/ (Daniel Siegel, MD)
brain’s ability to synthesize and innovate [82, 83] http://self-compassion.org/category/exercises/
and the result is integration of our cerebral hemi- (Kristen Neff, PhD)
spheres in a way that restores wholeness, and http://marc.ucla.edu/body.cfm?id=22 (Guided
with that, a connection to wellness. Meditations at UCLA)
http://www.simplybeing.org.uk/index.php/
ime-In (Reflection, Attunement,
T weblinks
Mindfulness)
Time-in is characterized by a very particular type Connecting Time
of conscious, focused attention on the inner life Social connection is a basic human need, much
of the self in the here and the now. Time-in like water, food, and shelter, and a sense of
focuses attention on one’s intentions and high- belonging is essential for wellness [84]. From our
lights awareness of awareness itself—the two earliest days of life, our connections to others
fundamental elements of being mindful [55]. provide a source of feeling seen, safe, and secure.
Time-in develops the capacity to be present with It is not surprising that these same feelings of
experience in a way that invites one to simply safety and attunement (seeing and feeling seen
notice (see what Hokusai says at the beginning of by others) describe the sense of belonging that is
this chapter) without judgment while promoting a core element for the ability to form and main-
curiosity and acceptance. This awareness is tain a highly functional medical team [57, 58].
essential for maintaining congruence and for cul- One of the most powerful measures of social sup-
tivating attunement (to self, others, and context). port is whether a person has an intimate, confid-
The literature on mindfulness-based stress reducing relationship, typically a spouse or a lover;
tion (MBSR) is growing rapidly and there is little friends or relatives function similarly but less
argument that mindfulness practices pay great powerfully [85]. In repeated studies, the connec-
tion to another human being has been demon- wide market in 2009 was $295 million dollars, a
strated to relieve stress, improve outlook, and 35 % growth since 2008, and representing an
mitigate the enormity of an impending challenge. annualized growth rate of 31 % since 2005.
Furthermore, it has been shown that individuals According to Aamodt and Wang:
who have diminished social connections may “[a]dvertising for these products often emphasizes
experience higher levels of stress and react more the claim that they are designed by scientists or
negatively to stress (have a narrower window of based on scientific research. To be charitable, we
tolerance). Given that stress is an important cause might call them inspired by science—not to be con-
fused with actually proven by science. One form of
of sleep problems, burnout, and depression, the training, however, has been shown to maintain and
buffering effect of social support on stress is per- improve brain health—physical exercise.”
tinent to our discussion of how the Healthy Mind
And they end their article by stating:
Platter provides the “nutrition” needed for well-
ness. A recent article in Harvard Business Review “So instead of spending money on computer games
on how successful businesses “manage their or puzzles to improve your brain’s health, invest in
a gym membership. Or just turn off the computer
emotional culture” introduces the term compan- and go for a brisk walk.”
ionate love. In organizations where employees
felt and expressed companionate love towards Exercise improves executive function and
one another, people reported greater job satisfac- moderate exercise reduces stress, decreases anxi-
tion, commitment, and personal accountability ety, and alleviates depression [88]—all of the
for work performance [86]. This was contrasted factors that contribute to burnout and deprive us
to cultures of fear (defined by threat rigidity), from wellness. While we sometimes consider
where employees felt intimidated, afraid of doing physical activity to be important for our bodies,
something for which they might be blamed, and the increasing data on how important it is for our
not sure who they could trust. In the latter organi- brains emphasizes why it is a staple in our quest
zations, burnout (manifested by all the distress for wellness.
elements measured and discussed above as well
as by high employee turnover) was high. Focus Time
Organizations that cultivate connections do a lot Focus time is the time we are able to focus, stay
to invite wellness because the need to belong and focused, and refocus efficiently and effectively.
to feel valued is a basic human need. To focus is to pay close attention. There is a direct
relationship between stress, focus, and health.
Physical Time One could even propose that the capacity to focus
There is little that needs to be emphasized here. attention is an ongoing indicator of mental fit-
Most of us are aware of the numerous wellness ness. The ability to remain focused by sustaining
benefits of exercise and other forms of physical attention is a function of self-control, and appears
activity (such as sports, hobbies, or playing). In to depend on a limited resource. Just as a muscle
an article in the New York Times [87], Sandra gets tired from exertion, acts of self-control cause
Aamodt and Sam Wang, respectively, editor in short-term impairments (mental depletion) in
chief of Nature Neuroscience and associate pro- subsequent needs for self-control, even on unre-
fessor of molecular biology and neuroscience at lated tasks. When this happens, we can begin to
Princeton, take a critical look at computer pro- feel overwhelmed and incapable, beginning a
grams to improve brain performance. The digital slide towards distress and burnout. Focus time
brain health and fitness software market is a requires the ability to refocus following distrac-
booming business. According to the 2010 indus- tion or during multitasking (as we continuously
try report called “Transforming Brain Health switch the spotlight of our attention back and
with Digital Tools to Assess, enhance and Treat forth between different stimuli). Performing sur-
Cognition across the Lifespan: The state of the gery is an extreme example of focus time.
Brain Fitness Market 2010” the size of the world- However, many surgeons have told us that after a
particularly challenging procedure that has leading people in our profession—including (but
required them to focus (and block out distrac- not limited to) decision making, vision crafting,
tions) over an extended period of time, they need consistency, knowledge, competent (or better)
to return to the quiet of their office and have some skills, ability to innovate or improvise, manage
“downtime” recovering. To achieve the wellness people, etc. Our second question is similar to the
benefits from focus time, we accept that our cul- one asked in the survey mentioned above: What
ture invites distractions that constantly occupy are the qualities demonstrated by these high per-
our attention and can serve to drain our energy. formers or leaders? The list invariably includes
An example of this is the experience commonly attributes like integrity, courage, resilience, self-
described by people who begin a mindful medita- accountability (absence of blame), perseverance,
tion practice—they become disturbed that their positivity during adversity, creativity, curiosity,
mind is so distractible and they believe that they humility, and compassion. Our third question is
are not succeeding at meditating. They are actu- the more difficult one for people to answer: How
ally noticing what is already there—our minds do you teach (or manifest) these latter qualities?
are in constant movement, attending to the pleth- In a culture that mandates perfection, and evalu-
ora of demands in our life. Simply noticing this is ates us simply by the one-dimensional outcome of
the first gift from meditation. The gift is in notic- patient survival, where do we measure qualities
ing and accepting without judgment [89]. Ability such as perseverance, grit, integrity, or courage?
to enhance and to maintain focus can be practiced How do we reward compassion, innovation, or
with meditation, but also with hobbies that resilience—especially since each of these quali-
require attention to a task. Over time, this helps ties is often associated with failure and struggle
individuals combat the feelings of being over- [90]? And if we can’t find a way to value and cel-
whelmed (burned out) that so often accompany ebrate the emergence of these attributes that are
multitasking and extended needs for focus. essential to wellness and wholeness, why are we
Practicing focus promotes wellness by helping us surprised when they get so suppressed and buried
learn how to minimize the “switching time costs” that the human spirit in us becomes burned out,
from multitasking that tend to deplete us. depressed, discouraged, overwhelmed, and
depersonalized?
In healthcare we are so accustomed to seeking
Additional Wellness Tips the answers “out there.” But to cultivate the qual-
ities mentioned above, the solution lies within us
Practicing wellness extends beyond including [62] and is beautifully illustrated by the words of
exercise, rest, and nutrition as part of our daily Ralph Waldo Emerson:
routine. Wellness affects our entire being and is What lies behind us
accompanied by the qualities we need to not only And what lies before us
prevent burnout, but also thrive—qualities like Are tiny matters
resilience, creativity, courage, and joy. Ironically, Compared to what lies within us.
in a recently published survey of cardiac surgeon
members of the Congenital Heart Surgeons
Society (CHSS) and the European Association of elease Yourself and Others
R
Congenital Heart Surgeons (EACHS), many from Unnecessary Judgements
pointed to these latter qualities as the reason for
their success [59]. When we have conducted lead- Our medical culture can be merciless. Patients
ership and team trainings, we sometimes ask three come to us for solutions to problems that are not
questions. The first is what are the responsibilities always solvable. Our profession demands that we
of a leader or of a high-performing team member? hold ourselves accountable to perfection and yet
We often garner a long list of important tasks and life is so fragile and unpredictable that no one has
performance imperatives that are expected from yet been able to get out of it alive. This creates an
impossible expectation (that with the right skills, that stallion is as fine as any in the land. What
we can prevent the inevitable) and yet most of us a stroke of good fortune!”
have readily embraced and agreed to sign up for the “Who can tell? It is neither good nor bad, it
challenge. When a patient survives, we are happy just is.” The old man said.
to take the credit and use it to exalt the magnifi- Two weeks later the son fell off the stallion
cence of our program (and in some cases, a team while riding and broke his leg. Friends of
member may be happy to adorn themselves with the old man came to him to express their
individual credit). And when a patient dies, we take sympathy. “It’s too bad your son broke his
it personally—which is really hard to do, so in leg, and right before the planting season,
many organizations, the blame for something that too. What bad luck!”
might have been inevitable lands somewhere, and “Who can tell? It is neither good nor bad, it just
often in someone. If this is hard to read, it is even is.” The old man said.
harder to witness, and yet the number of programs Two weeks later, war came to the land, and all
that now get scrutinized, reviewed, and criticized is able-bodied young men were drafted. The
growing annually—and you would be surprised to troop that contained the men from the village
know that many of these are among our nation’s was at the front in a bloody engagement, and
most exemplary sites. It is enough to make you the entire troop was lost. All the men from the
sick—and in fact, it will. No one of us can survive village died in battle.
this type of pressure and remain “well” [91, 92]. The young man with the broken leg stayed home.
So the next time there is an unwanted outcome His leg healed. He and his father bred many
and the “witch hunt” has gotten under way, sim- fine horses, and tended their fields.
ply disengage yourself. It’s “their” stuff and you
simply don’t need to own it. We all do the best we When something happens at work, don’t judge
can, and if we can maintain a hold on wellness, it. Judgment not only invites blame but it can be
we’ll survive to be able to help the next patient. a hallmark for lack of accountability—a deadly
Protect yourself from being the container for dis- trait in a leader. Life experiences provide us with
appointment and simply refuse to take it person- an opportunity to learn. In that way, it is neither
ally. The problems we sometimes are asked to good nor bad, it just is. What you do with it—that
solve are simply bigger than any of us. In fact, is the key to wellness.
they may not even be problems, which invites One technique that helps with this reframe is
this reframe (from a famous Taoist tale): to Tell Another Story. In cases where you find
Once upon a time in a village in ancient China yourself caught up in judgment, remember that
there was an old man who lived alone with his you are a complex adaptive system working in a
son. They were very poor. They had just a small complex profession—and take the invitation to
plot of land outside the village to grow rice and think creatively. What could be an alternative
vegetables and a rude hut to live in. But they also story (stories) that can explain someone’s behav-
had a good mare. It was the son’s pride and joy, ior, or help you understand their perspective?
and their only possession of value. What might be another way of looking at an out-
come as something from which you can gain a
One day the mare ran away. new insight or something positive?
The old man’s friends came to him and commiser-
ated. “What a wonderful mare that was!” They mbrace Joy and Gratitude
E
said. “What bad fortune that she ran off!” You have likely spent many years becoming a
“Who can tell? It is neither good nor bad, it just capable professional in our field and it has taken
is.” The old man said. sacrifice. Years of studying, nights on call, family
Two weeks later the mare returned accompanied events missed, commitment to learning, and con-
by a fine barbarian stallion. Friends and neigh- stantly getting better. You have developed
bors all came around and congratulated the yourself into a precious and valuable resource.
old man. “Now you have your mare back, and Take a moment to breathe and appreciate your-
self for all you have learned and all you have come; but to your real value—the parts of you that
accomplished. Take another breath and appreci- are dear and that need to be embraced and loved
ate yourself for how much you care. Let that in. and protected so that you don’t lose them. This is
Can you allow yourself to feel grateful for all you photographic proof that you are whole and valu-
have learned? Can you find a way to have com- able and preserving the unique and valuable “you”
passion for that part of you that cares so much for in a culture that wants to transform humans into
others? Can you reconnect to that core inside robots is what the rest of this article has been about.
you, that core you know is there, and find joy that Several years ago we were blessed to partici-
you have done something so meaningful with pate in a conference and serve on a panel with
your life. You can take that joy and gratitude with Irish poet, John O’Donohue, whose work we
you wherever you go. It can go a long way have quoted in the past [40]. John died (young) a
towards helping you achieve wellness. few years later of a heart attack, as he was slow-
Some ways to connect to gratitude are to ing down his life, trying to enjoy the fruits of his
spend the first few minutes each morning and labors and embrace his important relationships.
each evening before bed, reminding yourself of We want to end by sharing with you a blessing of
the things for which you have gratitude. You his for your work and we hope you can carry this
might also consider sending a short note or e-mail with you as you move forward.
to someone for whom you are grateful. Even
more powerful is to call them up, or visit them in For Work
person, and read your words to them. John O’Donohue
Photographic Proof
May the light of your soul bless your work
See if you can locate a photograph of yourself With love and warmth of heart
when you were younger. Perhaps you can find sev- May you see in what you do the beauty of your
eral. Take some time and reconnect to that person. soul
There is a lot of information in that photograph. May the sacredness of your work bring light and
renewal
Hokusai says to notice. What can you notice? To those who work with you
Notice your posture or your countenance. Notice And to those who see and receive your work
where you were at the time the photograph was May your work never exhaust you
taken. Who were you with? Who took the photo? May it release wellsprings of refreshment
Inspiration and excitement
Where are those people today? If you could say May you never become lost in bland absences
something to that younger you, what would you May the day never burden
say? If that younger you could say something to May dawn find hope in your heart
you, what would he or she say? What would you Approaching your new day with dreams
Possibilities and promises
imagine some of the real people whose stories we May evening find you gracious and fulfilled
shared at the beginning of this article might have May you go into the night blessed, sheltered and
said to their younger selves, and what might their protected
younger selves have said to them? Imagine if you May your soul calm, console and renew you
shared your photograph with other members of
your team—would they recognize you—the you
that you know is there, still inside you? Would you
feel safe sharing that part of you? Or would it feel References
scary, and perhaps make you feel vulnerable?
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Executive Leadership and Surgical
Quality: A Guide for Senior 15
Hospital Leaders
Susan Moffatt-Bruce and Robert S.D. Higgins
“Quality is never an accident; it is always the result of high intention, sincere effort,
intelligent direction and skillful execution; it represents the wise choice of many
alternatives.”
—William A. Foster
It is with this background that we examine the

Introduction role of department and hospital leadership in the
development and institution of these quality
Since the early 1990s when reports of the Veterans improvement efforts. Historically, the Institute
Administration collaborative efforts to assess and of Medicine has defined the quality as “the
improve surgical outcomes were published, quality degree to which health services for individuals
assessment and process improvement initiatives and populations increase the likelihood of
have gained progressive importance in the daily desired health outcomes and are consistent with
function of the modern department of surgery. In current professional knowledge.” This clearly
1994, the National VA Surgical Quality applies to the field of surgery. In many surgical
Improvement Program (NSQIP) was established in quality programs, however, indicators were and
all 132 VAMC’s performing surgery [1]. In 1998, often continue to comprise the traditional mea-
Khuri et al. presented the first national, validated, sures—complications and deaths reported in a
outcome-based, risk- adjusted report outlining peer review conference setting—rather than
structure, data collection, analysis and reporting of more positive components of quality. In the con-
surgical outcomes. Validation of these process text of the Affordable Care Act, the modern sur-
improvement efforts more than a decade later gical leadership team must develop a vision
suggest that continuous quality assessment in consistent with what CMS has defined patient
NSQIP, and these programs enhance surgical out- safety efforts as “initiatives that go beyond the
comes [2]. current Quality Assessment and Assurance
(QAA) provision, and aim to significantly
expand the intensity and scope of current activi-
ties in order to not only correct quality deficien-
cies (quality assurance) but also to put practices
S. Moffatt-Bruce, MD, PhD, MBA, FACS (*)
Quality and Operations, The Ohio State University in place to monitor all services to continuously
Wexner Medical Center, 130 Doan Hall, 410 West improve performance” (Section 6102 (c) of the
10th Avenue, Columbus, OH 43210, USA Affordable Care Act).
In this chapter, we will define the role and
R.S.D. Higgins, MD, MSHA responsibilities of the surgical quality officer,
Department of Surgery, Johns Hopkins Medical
goals of the program, training and resources
Center, 720 Rutland Avenue, Ross 759, Baltimore,
MD 21205, USA necessary to implement a successful value-
e-mail: [email protected] based quality program, and strategies necessary

226 S. Moffatt-Bruce and R.S.D. Higgins
to achieve departmental and institutional goals CSQO has the privilege and responsibility of
that are deemed successful. The ultimate goal is enthusing and supporting every surgeon, every
to establish a “culture of surgical safety” and nurse, every resident and student to ensure the
“continuous improvement” that systematically best outcomes. The quality and patient safety
ensures in the words of Director Clancy of the field is, out of necessity, developing into a disci-
Agency for Healthcare Research and Quality— pline or expertise in how to truly engage with
”Getting the right care to the right patient at the organizational culture and translate quality and
right time—every time.” patient safety goals and objectives into concrete
aims and metrics that can be tracked using disci-
plined approaches [4].
ole and Responsibilities
R Traditionally, CSQO’s were the chief medical
for Successful Oversight officers in smaller hospitals or the Chair of Surgery
in other hospitals with smaller departmental struc-
Healthcare and the provision therefore is a tures; often the role of the CSQO was perceived as
remarkable combination of skill, clinical judg- something “extra” or as a compliance requirement
ment, and teamwork. Those that work within it to supplement the “real work” of patient care.
are indeed privileged to be a part of the profes- Often, the “safety officer” or “quality assurance
sion of treating the ill, reducing suffering, and person” was little respected nor heeded. In today’s
sometimes, simply supporting the patient and healthcare environment, with public reporting of
family. However, there are times when our care, medical errors and support for the concept that
despite our best intentions, does not produce the most patient injuries are a result of system failures
outcomes we had intended and may even cause and not bad doctors, the role of the CSQO is criti-
harm to the patient. More than a decade ago, the cal [5–7]. The CSQO must have the ability to
Institute of Medicine released its famous report, acknowledge these root causes, develop counter-
“To Err Is Human,” which set an ambitious measures, and impact change. Additionally, the
agenda for the world to reduce the number of CSQO must have essential leadership traits which
patients harmed by medical errors and prevent- include the ability to assess clinical practice gaps,
able adverse events [3]. understand the science of improvement and reli-
ability, foster transparency, engage other physi-
cians and nurses, and set clear outcomes and
ho is the Chief Surgical Quality
W measurable metrics [8–11].
and Patient Safety Officer? Identifying the right CSQO, means finding an
individual that embraces change and values con-
The infamous “call to arms” that started more tinuous performance improvement. The CSQO
than a decade ago has included creating a culture must be able to lead initiatives, address issues,
of safety and accountability. Changing culture is generate support from other surgeons, and engage
hard work and it takes more than a checklist to the right team. Often, these leaders need training
achieve a safe environment for our patients and in process improvement and conflict resolution
surgical teams. Creating a culture of safety means [12]. They need dedicated time to network with
ensuring that the highest quality of care is not just others, attend national conferences in Quality and
a project or flavor of the month, but rather at the Patient Safety, conduct meaningful rounding, and
core of what we do every day for every patient. actively work with other team members on proj-
Creating this environment for a surgical depart- ects and rapid cycle improvement. Experience
ment should ideally be the primary strategic dealing with administrative issues such as
responsibility of the Chief Surgical Quality resource allocation, contracting, finance and bud-
Officer (CSQO). While no one person can be geting, and strategic planning may be very helpful
responsible for all patients and outcomes, the in that these administrative skills may facilitate
15 Executive Leadership and Surgical Quality: A Guide for Senior Hospital Leaders 227
goal setting and outcomes measurement. The time little time to spare for the departmental or organiza-
must be protected and supported by the tional quality agenda. At worst, relationships
Department Chair and hospital administration as become strained when there is a tension between
truly value added and should therefore be appro- the surgeons and the agenda of the department as it
priately compensated [13, 14]. works within the healthcare system. This can be
Lastly, the ideal CSQO should have clinical affected by the various employment models for
experience that has allowed him or her to have surgeons.
achieved a level of clinical expertise that is appre- Since most surgeons have had little training in
ciated and recognized by other surgeons and team just culture development, continuous improve-
members. The CSQO should be at a point in their ment, high reliability or even quality data collec-
career whereby they can still maintain their surgi- tion and analysis, additional and dedicated training
cal skill with a smaller volume of cases. In aca- is highly advantageous. There are different degrees
demic medical center settings, it is unlikely that a to which the CSQO and fellow surgeons can be
junior assistant professor would have achieved this trained and can range from online modules, which
stature within the first few years after residency. take 12 h, to a Master’s in Operational Excellence
Similarly, a surgeon at the end of their career may or Business Administration which can take 2 years.
not be the ideal candidate. The idea of using qual- Table 15.1 lists a number of potential and gradu-
ity and patient safety as an “exit strategy” flies in ated training opportunities. At a minimum, training
the face of having a CSQO that is current, innova- in Six Sigma or Lean concepts is recommended.
tive, and continuously improving [15]. While there is no “one size that fits all,” as training
is completed, the CSQO will find that they are bet-
ter able to address quality issues and are more able
raining and Resources Required
T to engage surgeons successfully because they
for Success understand the failure modes and how to facilitate
the solutions [18]. Additionally, this training will
The CSQO must engage with fellow surgeons and allow the CSQO to represent the Department of
develop a team approach to continuous improve- Surgery more appropriately at the healthcare sys-
ment. Additionally, designing reliable processes tem level with a very sound understanding of
that mitigate human error involves critical assess- national quality metrics and ranking systems,
ment of current processes, careful planning, and such as U.S. News and World Report, which are
the use of the science of reliability. Learning the heavily influenced by surgical performance.
science of reliability is essential to the CSQO role
as well as to fellow team members [16]. Most
healthcare leaders and surgeons did not learn the Reporting Structure
science of reliability; just culture or performance and Administrative Committee
management in their professional training and Support
some may not even know that it exists. The CSQO
is responsible for engaging surgeons in improve- Continuously improving our processes to ensure
ment initiatives which have historically been a safe and high quality care is not only what the
challenge for healthcare organizations because sur- public demands of us; it is now tied to our reim-
geons’ primary professional focus is their own bursement. Authorized by the Affordable Care
practice—the quality of care they personally Act, the Hospital Value-Based Purchasing (VBP)
deliver and the economics associated with that program is the beginning of a historic change in
care. In many instances, the priorities of surgeons how Medicare pays healthcare providers and
can seem out of alignment with the quality issues facilities—for the first time hospitals across the
that face the healthcare system as a whole [17]. At country will be paid for inpatient acute care
best, surgeons have often perceived that they have services based on care quality, not just the
228
Table 15.1 Training and professional development

Programs Details Link
American Society for Quality ASQ delivers Lean Sigma training using http://asq.org/healthcare-use/training/overview.html
Learning Institute D-M-A-I-C methodology with integrated Lean
tools and techniques
STEEEP Academy (safety, The STEEEP Academy teaches healthcare http://www.baylorhealth.edu/STEEEPGlobalInstitute/STEEEPAcademy/Pages/default.aspx
timeliness, efficacy, efficiency, leaders the theory and techniques of rapid-
equity, and patient-centeredness) cycle quality improvement
National Committee for Quality NCQA offers a host of live educational http://www.ncqa.org/EducationEvents.aspx
Assurance seminars and just-in-time webinars
Institute for Healthcare Conferences, In-Person Training, Web-based http://www.ihi.org/education/Pages/default.aspx
Improvement Training, Audio and Video Programs, IHI Open http://www.ihi.org/education/IHIOpenSchool/Pages/default.aspx
School, IHI Fellowship Program
Emory University Lean Six Sigma Certificate Program http://ece.emory.edu/sixsigma/
Health Resources and Services Quality Improvement & Risk Management http://www.hrsa.gov/publichealth/guidelines/qualityimprovement.html
Administration Training
US Department of Health and
Human Services
TeamSTEPPS TeamSTEPPS is a teamwork system designed http://teamstepps.ahrq.gov/
AHRQ for healthcare professionals
World Health Organization WHO Patient Safety has developed a range of http://www.who.int/patientsafety/education/en/
training materials and tools
US Cochrane Center Web course created by the United States http://us.cochrane.org/understanding-evidence-based-healthcare-foundation-action
Understanding Evidence-Based Cochrane Center as part of a project
Healthcare undertaken by Consumers United for
Evidence-based Healthcare (CUE)
• Johns Hopkins Bloomberg
School of Public Health
S. Moffatt-Bruce and R.S.D. Higgins
Johns Hopkins Medicine Workshops and e-Learning http://www.hopkinsmedicine.org/armstrong_institute/training_services/workshops.html
Armstrong Institute for Patient The Armstrong Institute hosts training
Safety and Quality workshops throughout the year targeted to a
wide range of healthcare professionals, from
front line staff to executives
Intermountain Healthcare The Advanced Training Program (ATP) offers http://intermountainhealthcare.org/qualityandresearch/institute/courses/atp/Pages/
a course for healthcare professionals who need home.aspx
to teach, implement, and investigate quality
improvement
Duke University Patient Safety—Quality Improvement http://patientsafetyed.duhs.duke.edu/
EBM workshop http://sites.duke.edu/ebmworkshop/
Six Sigma Green Belt Healthcare Focuses on Six Sigma Green Belt training on http://cpd.engin.umich.edu/professional-programs/six-sigma-greenbelt-healthcare/
University of Michigan healthcare applications index.htm
Masters of Operational An 18-month degree focusing on developing http://fisher.osu.edu/mboe/
Excellence leaders leadership in the emerging, rapid and
Fisher College of Business, The continuous improvement environment found in
Ohio State University leading service, healthcare, and manufacturing
organizations
15 Executive Leadership and Surgical Quality: A Guide for Senior Hospital Leaders
229
q uantity of the services provided. In order to suc- Table 15.2 Department of surgery quality committee
membership
ceed and sustain gains in reducing care-associ-
ated adverse events while continuing to fund our CSQO
mission to provide high quality care, healthcare Divisional or departmental representatives (and
alternate)
institutions must embrace standardized, evi-
Perioperative nursing
dence-based practices as well as purposeful
Surgical intensive care nursing
engagement of the entire healthcare team. Human
Surgical unit floor nursing
factors and in particular, unanticipated events in
Pharmacy
the operating room during high acuity surgery are
Epidemiology
a stark and often unnerving reality [19, 20].
Chief residents
Therefore, we as surgeons, partnering with the
Quality managers
CSQO and hospital administration, must be
Data analysts
responsible to develop a strong safety culture that
Ad Hoc members: risk management, infection control, etc.
demonstrates effective coordination of care, Medical students
identifies gaps and engages caregivers who pro-
actively and thoughtfully bring solutions forward
to provide the highest quality of care for all medical students should always be encouraged to
patients [21]. attend. Risk managers and compliance represen-
Every department of surgery and healthcare tatives may be appropriate at times but should not
institution is structured a little differently. dominate the conversations. Quality managers
Nonetheless, some form of departmental Quality and data analysts that assist with data collection
Committee, that is aligned with the healthcare and process improvement should be considered a
institution is essential. The true north for such a part of the committee and not simply facilitators
committee should be providing the highest qual- of the process. Table 15.2 considering busy oper-
ity of care for all surgical patients, which implies ating schedules, each divisional quality lead
care that is safe, efficient, effective, patient cen- should have an alternate and at a minimum, each
tered, timely, and equitable [22]. It is the respon- divisional lead should complete basic Quality
sibility of the CSQO to ensure that all of these and Patient Safety training prior to being nomi-
Institute of Medicine aims are fulfilled within a nated to the departmental committee. The report-
department and health system so that the delivery ing of the departmental quality committee should
of quality care is given equal attention and priori- be to the Hospital or System level Quality and
tization. To that end, the departmental Quality Patient Safety Committee, and the CSQO should
Committee should have a representative from be an active member of a larger hospital over-
each surgical division within the Department. sight committee. Similarly, the CSQO should
Meetings are typically monthly and often the identify a Co-chair of the Departmental Quality
timing may need to be creative to accommodate Committee to attend the system level meeting
surgical schedules. Additional key members of when he or she is unavailable to ensure a contin-
the committee include representatives from the ued presence at the health system level.
operating room—particularly nursing, the surgi- As each hospital or medical center may be
cal intensive care unit, the surgical care unit, and organized differently, the above Quality commit-
pharmacy. Data managers and/or epidemiologists tee structure should be considered flexible. For
and hospital quality administrative support are example, if a hospital has multiple surgical
essential. Other invited guests should be chosen departments, then a representative of each depart-
depending on the topic being discussed. For ment should be a member of the committee,
example, infectious disease representatives and rather than divisional members. In addition, at
infection control staff would be appropriate when large members are important to help message to
discussing wound infection rates. Residents and the middle part of the organization.
Strategic Alignment and Leadership while he or she is leveraging the institutional

support to render the initiative successful [31].
Although the CSQO charge may vary from Sentinel events often can only be addressed
institution to institution, in addition to elimi- after thorough root cause or common cause
nating adverse events, he or she will often be analysis. To that end, the CSQO may serve as
asked to lead efforts to balance a sometimes the lead physician on these workgroups and be
conflicting set of responsibilities. This list responsible for devising and implementing
includes, but is not limited to, educating sur- countermeasures to prevent them from happen-
geons and trainees about quality and process ing again. Inherent to this process is the shar-
improvement, achieving compliance with a ing of often sensitive data when a surgeon or
growing list of external mandates that may not surgical team has been involved in a “never
always seem rational, standardizing and event” [32]. By focusing on the systems issues
streamlining care pathways, ensuring appropri- and sharing the fixes, the CSQO can further the
ateness, and making difficult decisions about culture of safety and continuous improvement,
resources. The CSQO requires a unique skill without compromising the integrity of the sur-
set, including not only the ability to listen and geon. Using the departmental Quality
a willingness to work for consensus, but also Committee, to share events and patient safety
the authority and fortitude to make some deci- opportunities is an appropriate venue that is
sions that may not always be greeted with safe and productive. Opportunities that have
enthusiasm. Ultimately, the CSQO is respon- been realized through careful analysis could be
sible for aligning the Department of Surgery shared using standardized storytelling which
with hospital or institutional initiatives. Often, could be distributed electronically or in poster
hospital goals or key result areas are signifi- format in resident rooms or the perioperative
cantly impacted by surgical services and out- surgeon’s lounge as seen in Fig. 15.2 [33].
comes. Having the department understand how
their performance impacts the institution as a
whole is vital to sustained improvements. Clear esources and Relationships Critical
R
definition of the reporting structure and quality to Success
oversight is key, and understanding that not
only is the reporting fixed, but that the ultimate Over the past 25 years, measurement of health-
responsibility of the leadership and board can care processes and outcomes has been evolving
be leveraged is often very helpful. An example and rapidly changing. Initially, the focus was on
of one is provided in Fig. 15.1. Impacting mor- data collection and reporting. Of late, there is a
tality and reducing sentinel events, including push from business groups, state and national
retained foreign bodies and wrong site proce- agencies, and most importantly, patients to ask
dures, the CSQO may serve as the project questions about healthcare outcomes, cost, and
leader or champion for programs aimed at pro- patient experience. To address these questions at
cess improvement [23–25]. Approaches such as the surgical divisional or departmental level,
team training or Crew Resource Management there must be good and validated data. According
are really surgically driven programs that have to Provost and Murray, “Data are documented
been shown to improve outcomes [26–30]. observations or results of performing a measure-
Without the leadership and direction of the ment process. Data can be obtained by perception
CSQO and key members of surgical depart- or by performing a measurement process.” [34].
ments and divisions, such programs are unlikely In order to leverage data and create ultra-safe
to be successful and could serve as a source of environments for patients, not only are resources
frustration for all surgeons involved. The CSQO needed, but a relationship between departments,
should be the advocate for the individual sur- clinical and administrative, must be forged and
geon when these initiatives are being rolled out maintained.
Fig. 15.1 Quality oversight structure. An example of a nization and to which the subcommittees responsible for
quality oversight structure is provided, whereby the hospi- quality, resource utilization, evidence-based practice, and
tal or health system board is ultimately responsible for patient experience report. The individual department
quality and patient safety. The Leadership Council com- quality committee would report to the Clinical Quality
prises key clinical and administrative leaders in the orga- and Patient Safety Committee
eveloping a Culture of Safety

D Despite a dedicated interest at many levels to
and High Reliability at All Levels ensure the highest quality of care for patients,
studies have shown that progress in patient safety
The root causes for most events that occur among has been exceedingly slow, secondary to lack of
surgical patients include lack of communication, both clarity regarding the definition and standard
lack of teamwork, lack of patient involvement, methodology to assess iatrogenic patient harm
lack of reliable processes, lack of organizational [37]. Additionally, some researchers believe that
emphasis on safety and reliability, and the inabil- there is a lack of will at the senior leadership level
ity of the department or organization to continu- and consequently a lack of resources and focus on
ously learn from its mistakes [35]. Understanding the hard work necessary to redesign systems for
that a just culture is one of trust, not only a cul- high reliability performance [10, 38]. There con-
ture in which people are encouraged to provide tinue to be reports of fear and intimidation that are
essential safety-related information, but also a still uncomfortably widespread in healthcare, and
culture in which it is clear about where the line in surgical disciplines in particular, which leads to
must be drawn between acceptable and unaccept- an overwhelming reluctance of physicians and
able behavior as defined by James Reason’s five- staff to escalate concerns about safety or reveal
part algorithm for creating accountability [36]. their own errors or near-miss events [10, 38, 39].
÷ Scenarios
A patient in the OR undergoing a facial fracture repair had surgical lubricant placed on a corneal shield
instead of ophthalmic lubricant. The corneal shield was placed in the eye during surgery. Exposure to
surgical lubricant led to chemical injury of the cornea. The cornea injury improved and the patient was
discharged with required follow-up to determine the long-term impact of the chemical injury.
÷ Process Issues
There was a misconception that surgical lubricant is acceptable for use in the eye and could be
placed on a corneal shield.
Ophthalmic lubricant is used every time a corneal shield is inserted, but was not on surgeon
preference cards for procedures.
Ophthalmic lubricant is only located in the anesthesia carts and was not available to the circulating
nurse in the operating room. The item was passed from anesthesia to the surgical resident and did
not follow the policy requiring items passed on the surgical field be handled by the circulating nurse.
÷ My Role
Look Alike Products: Unfortunately many products look similar, read labels and their contents
carefully. Attempt not to locate look alike products together.
Fig. 15.2 Lessons learned poster. When serious safety Posters like this can be used in email alerts or in the sur-
events occur, it is the responsibility of the CSQO to share geons’ lounge to reach a broad audience in a productive
lessons learned and what process issues were addressed. fashion
Nevertheless, there are several examples of safety and consistently good outcomes has been
remarkable and measurable advances in patient consistent and genuine engagement by leadership
safety in individual health systems [39, 40]. A [14, 41]. There is an increasing focus on the impor-
number of notable organizations and programs tance of leadership, specifically with regard to the
were able to achieve and sustain significant reduc- education of physicians, reflected in new require-
tions in preventable adverse events and hospital ments and guidance of the Accreditation Council
acquired infections with a reduction in sentinel for Graduate Medical Education [42]. Nursing
events, reduction in risk-adjusted death rates, leadership has also been highlighted for its critical
improvement in safety attitude/culture throughout role establishing a culture of safety and improving
the organization, and increased reporting with clinical outcomes by directly affecting clinical
more effective investigation into patient safety workflow and patient-care processes at the bedside
incidents [40, 41]. The common theme among all [43]. Effective process redesign focuses on both
of these successes is that improved patient safety the reduction of errors and identification of risks to
metrics have translated into improved staff morale ensure that errors are caught and patients are not
and reduced costs resulting from shorter hospital harmed.
lengths of stay. Much research has been done on what exactly
The most significant characteristic shared by this “culture of patient safety” entails. A robust sur-
organizations that have made progress in patient vey of California hospitals found seven characteris-
tics that were key: (a) commitment to safety at the ing uses crew resource management theory from
highest level, (b) necessary resources for safety are aviation that has been adapted for healthcare [21,
provided, (c) safety is the highest priority, (d) all 31, 47, 48]. The Veterans Health Administration
coworkers communicate effectively about safety (VHA), the largest integrated healthcare system
concerns, (e) hazardous acts are rare, (f) there is in the United States, implemented a national
transparency in reporting and discussing errors, and operating room team training program and stud-
(g) safety solutions focus on system improvement, ied the outcomes [20]. The investigators found
not individual blame [10]. Building and nurturing a that with every additional 3 months of team train-
culture of patient safety is directly correlated with ing completed, mortality was reduced in all types
improved clinical outcomes and reduced errors, such of surgical patients undergoing a variety of cases
as shorter length of stay, fewer medication errors, of differing levels of complexity. Team training,
lower rate of ventilator-associated pneumonia, lower as it currently exists in our operating rooms, relies
catheter-related bloodstream infections, and most heavily on checklists and effective care transition
significantly, a lower risk-adjusted mortality [44]. communications. The use of these checklists has
In order to achieve a culture of safety and these been shown to globally reduce morbidity and
improved outcomes, leaders must demonstrate mortality as made evident by the World Health
that they value transparency and encourage disclo- Organization’s Safe Surgery Saves Lives pro-
sure of adverse events [21]. By analyzing these gram [22]. Since this seminal publication, the
events, organizational learning and system Safe Surgery Checklist, as popularized by Dr.
changes are then possible to prevent similar errors Atul Gawande, has spread from the operating
from occurring. There are several validated admin- room to every aspect of patient care. Dr.
istrative and clinical tools effective in establishing Pronovost’s success in reducing central line
a culture of safety [41]. It is essential to first accu- infections to almost zero in intensive care units
rately measure the safety culture. This will provide using a standardized checklist is another prime
the organization with baseline data important in example of a hardwired “safety tool” improving
assessing the effect of any intervention. The sur- care [49]. However, after considering the find-
vey most frequently used is the Hospital Survey on ings of Hu et al., and Urbach et al., [50], perhaps
Patient Safety Culture that was developed by the we have been overly prescriptive in hard wiring
federal Agency for Healthcare Research and processes without prior engagement of surgical
Quality. This tool has been used extensively to teams, and rather than capitalizing on what sur-
develop patient safety programs in hospitals across geons are traditionally known for- resilience. The
the country and AHRQ now publishes compara- investment in such programs is real, but the
tive data to support continuous improvement and results can be impressive [31, 51].
collaboration [45]. Another powerful leadership The Lucian Leape Institute at the National
tool in the hospital setting is Patient Safety Patient Safety Foundation has endorsed five
Leadership WalkRounds, in which a senior leader overarching principles for transforming hospitals
undertakes walking rounds to discuss patient safety and clinics into high-reliability organizations.
with staff and patients/families. Safety issues are These include transparency in disclosing errors
recorded, prioritized, and addressed with system and quality problems, integration of care across
wide changes at subsequent meetings. This has teams and disciplines, engaging patients in
been an effective tool in demonstrating that senior safety, restoring joy and meaning in work, and
leadership value patient safety and will address reforming medical education to focus on quality
adverse events and vulnerable systems in a nonpu- and safety [41].
nitive manner [40, 46]. Worker satisfaction is critical to get any buy-in
The use of Crew Resource Management across in a patient safety culture. It directly correlates
entire departments and hospitals has been part of with improved patient satisfaction and outcomes.
a culture transformation [26–29, 31]. Team train- Transparency is essential to understand the current
state of patient safety and to develop a learning etric Development and Goal

M
culture in which mistakes inform system-wide Setting
change and there are no punitive consequences
for disclosing medical errors. This will align To measure quality, the CSQO and key surgical
with healthcare providers’ ethical obligation leaders will need to take several steps. First, the
to disclose medical errors and apologize for aims must be set, that is, to make the data collec-
patient harm. Patients and their families should tion relevant, all measurement should be directly
be engaged in their clinical care through connected to the departments, hospital and health
informed medical decisions and self-manage- systems goals. Next, priorities for quality and
ment [52–54]. patient safety efforts for the department must be
established, such as reducing surgical site infec-
tions and these must be in alignment with the
Data Analytics and Validation institutional priorities and efforts. After selecting
the specific measure, there must be consensus on
There are currently many sources of surgical data the operational definition so that when the data is
and analysis that are required to evaluate the per- finally collected and presented there is no “the
formance of surgeons as well as divisions and data is incorrect” mentality [55, 56]. Developing
departments as a whole. The registries that are a data collection plan and the actual acquisition
currently the most developed and are likely to be of data will likely require hospital or health sys-
found within a surgical department can involve tem support. The CSQO needs to understand this
almost any surgical discipline. It is the responsi- process well enough to represent the department
bility of the CSQO to have a sound understand- at health system budget and resource meetings.
ing of the data collection methodology, the Lastly, there must be a plan to analyze the data
analysis and the reporting mechanism associated with the appropriate stakeholders and be trans-
with the registries the Department of Surgery parent with sharing the results, good or bad.
intends on implementing. A dedicated surgeon Taking action to improve outcomes is an inter-
champion should be identified for the different professional process that starts with good data,
registries, separate from the CSQO, and they can appropriate analysis, and being grounded in the
assist in the analysis of results and drive change. aims and goals of the surgeons, divisions, and
Table 15.3 is a listing of the most commonly used department as a whole. Table 15.4 is an example
surgical databases. of metrics and goals set at an institution level.
Table 15.3 Surgical quality improvement registries

Specialty Database Link
All surgical National Surgical Quality http://site.acsnsqip.org/
specialties Improvement Project (NSQIP)
(Essential, small/rural hospital,
procedure targeted version or
pediatric version)
Bari NSQIP (Bariatric Surgery) http://www.mbsaqip.org/
Cardiac and thoracic Society of Thoracic Surgeons www.sts.org
surgery Quality database
Vascular surgery Society of Vascular Surgery http://www.vascularqualityinitiative.org/
Quality Improvement program
Trauma surgery Trauma Quality Improvement http://www.facs.org/trauma/ntdb/tqip.html
program
Transplant surgery Scientific Registry of Transplant http://www.srtr.org/
Recipients
All surgical University Health System https://www.uhc.edu/
specialties Consortium (UHC)
236
Table 15.4 Goals and metrics for success (system level). The goals for quality and patient safety improvement need to be established yearly. The previous year’s success and
the goals need to be clearly defined. The means by which the data will be collected and validated need to be transparent
Baseline year Current
Performance incentive metrics (“threshold”) FY15 FY16 (“target”) goals performance Description (health system)
CAUTI (per 1000 foley days/Standardized 1.156 0.854 0.75 All patients anywhere in the hospital that develops a UTI
Infection Ratio—SIR) with a foley in
CLABSI (per 1000 line days/SIR) 0.577 0.46 0.71 All patients anywhere in the hospital that develops a BSI
from a Central Line
cDiff (per 10,000 patient days/SIR) 0.824 0.75 0.74 All patients anywhere in the hospital that develop C diff
SSI Colon Surgery (per 100 procedures/SIR) 0.982 0.751 0.47 Deep infections after any sort of colon surgery
Hand hygiene 90 % 95 % 93 % Rate from observation program of clean in/clean out
Mortality index 0.64 0.63 0.65 UHC all inpatient mortality index
Sepsis mortality index 0.88 0.89 0.84 UHC mortality index for patients with a sepsis diagnosis
code
PSI 90 0.64 0.62 0.66 Composite measure: PSI 03 Pressure Ulcer Rate; PSI 06
Iatrogenic Pneumothorax Rate; PSI 07 Central Venous
Catheter-Related Blood Stream Infection Rate; PSI 08
Postoperative Hip Fracture Rate; PSI 09 Perioperative
Hemorrhage or Hematoma Rate; PSI 11 Postoperative
Respiratory Failure Rate; PSI 12 Perioperative Pulmonary
Embolism or Deep Vein Thrombosis Rate; PSI 13
Postoperative Sepsis Rate; PSI 14 Postoperative Wound
Dehiscence Rate; PSI 15 Accidental Puncture or
Laceration Rate
PSI 12 Post Op PE/DVT rate 9.18 7.87 6.41 Rate per 1000 discharges
S. Moffatt-Bruce and R.S.D. Higgins
Total falls per 1000 patient days 1.64 1.55 1.44 All falls and benchmarked with NDNQI
Injury falls per 1000 patient days 0.37 0.32 0.35 Falls with injury level 1 or higher benchmarked with
NDNQI
Overall 30 days all cause readmission rate 13.20 % 11.90 % 13.30 % All cause readmissions back to OSUWMC for any reason
HCAHPS overall rating 75.30 % 79.40 % 78.20 % Percent of those surveyed who gave scores of “9” or “10”
if patients would recommend OSUWMC
HCAHPS doctor communication 81.10 % 82.80 % 82.30 % “How well did the doctors treat with courtesy and respect,
listen carefully, explain things”
HCAHPS nurse communication 80.30 % 81.00 % 81.50 % How well did nurses treat with courtesy and respect, listen
carefully, explain things, answer the call button
CGCAHPS 90.80 % 96.00 % 90.80 % Would you recommend this provider’s office
(yes-definitely)
CGCAHPS test results 76.90 % 94.00 % 87.30 % Follow up to give test results (yes)
Medicare spending per beneficiary 0.998 0.98 0.998 Cost for 3 days prior, inpatient stay, and 30 days post
15 Executive Leadership and Surgical Quality: A Guide for Senior Hospital Leaders
237
The data collected by the CSQO and shared Continuous Improvement Training
with divisions and surgeons often rolls up into and Support
national rankings and grading systems.
Therefore, the CSQO must understand, at a Healthcare providers involved in improving our
minimum, how the surgical data and indicators care delivery system must be able to create a just
affect the Joint Commission accreditation sta- and accountable culture, implement highly
tus, the Centers for Medicare and Medicaid reliable systems, and foster transparency.

Value-Based Purchasing program, and the Additionally, designing reliable processes to miti-
U.S. News and World Report rankings. To that gate human error involves critical assessment of
end, division quality and patient safety cards current processes, careful planning, and the use of
need to be formulated, reviewed monthly, and the science of reliability. Learning the science of
be part of the leadership’s compensation as to reliability is essential as understanding the funda-
the success or challenges. Figure 15.3 is an mental cornerstone of all projects is continuous
example of a General Surgery divisional score- process improvement.
card that is in alignment with the institutional Since most healthcare providers have had
metrics and goals. Lastly, as each surgeon little training in just culture development, high
influences the performance of the department reliability or even quality data collection and
and the institution, individual scorecards are analysis, additional and dedicated training in
essential (Fig. 15.4). The metrics that formu- process improvement is highly advantageous.
late these scorecards must be in alignment with There are different degrees to which healthcare
the division and the institutional as a whole team members can be trained, and can range
(Fig. 15.5). from online modules, which take 12 h to
Fig. 15.3 Division level scorecards. Using hospital quality metrics including mortality. Case mix index can be
resources that have access to system level data, scorecards a surrogate marker for appropriate documentation and
can be generated that focus on efficiency metrics includ- clinical documentation programs that may have been
ing length of stay and all-cause readmissions as well as instituted
Fig. 15.4 Surgeon-specific scorecards. Surgeons should NSQIP and STS as well as institutional data. Mortality
be able to see their own performance on a quarterly to and peer review of clinical care should be included in the
semiannual basis. This can be provided through dedi- scorecard. HCAPS and patient complaints should be
cated, secure web sites or in a written format. The data shared through this format. There should always be a peer
should include acceptable quality data bases including comparison and a trend over time that can be reviewed
Master’s in Operational Excellence or Business I nnovation in Process Improvement:

Administration which can take 2 years as men- Engaging the Team
tioned earlier in the chapter (Table 15.1).
Management techniques from business and In traditional healthcare organizations, however,
industry including Lean, Six Sigma and the responsibility and accountability for patient safety,
Toyota Production System (TPS) have often patient satisfaction, staff satisfaction, and opera-
been studied in relation to healthcare process tional efficiency have resided with senior leaders
improvement for many years [7–10, 13, 14, 19]. who are not clinically responsible for the patients.
These techniques share common foundations What is needed, in most instances, is a more grass
such as maintaining respect for people and roots approach that engages those on the front
focusing on continuous improvement. But across lines of healthcare to identify challenges, imple-
approaches there also exists a tension between ment solutions, and sustain change in the areas of
medical and business approaches to process quality, patient safety, resource utilization, patient
improvement [15, 19, 20]. In practice, Lean and experience, and financial responsibility [58].
other process improvement methodologies must Really that should be termed continuous improve-
take into account the context and environments ment rather than process improvement. The tradi-
in which they are applied, with long-term suc- tional model of rapid cycle improvement addresses
cess only possible if organizations can change one issue at a time, but teams outside the clinical
behaviorally and culturally to embrace a focus area are likely to be less successfully sustained.
on continuous improvement [57]. As a perfor- We proposed a more bottom- up, grass roots
mance improvement process, for example, Lean approach that engages those on the front lines of
philosophy calls for value creation through elim- healthcare to identify challenges, implement solu-
ination of waste. These wastes are common in all tions, and sustain change in the areas of quality,
industries and perhaps are most evident in patient safety, resource utilization, patient experi-
healthcare [22, 23]. ence, and financial responsibility.
Fig. 15.5 Quality metrics and incentives. Working with for the success of these goals is listed and includes the
the CEO of the health system, quality, patient safety, and CMO, CQO, CFO, CEO, and department chairs. These
efficiency goals have been established. One year and 3 goals are then used in the compensation and incentive
year goals have been established. The responsible party basis of key leader contracts
As performance and quality improvement are cate time to being trained as a Yellow Belt Lean Six
important elements of all population health Sigma facilitator while still staying clinically
management approaches, we sought to explore active. The facilitators were nurses, pharmacists,
how a performance improvement strategy and technicians. The facilitators completed Lean
focused on patient safety improvement could be Six Sigma Yellow Belt training through Ohio
developed and deployed in a large academic State’s Fisher College of Business in their first year
medical center. Operations councils were cre- of Operations Council deployment. All process
ated that were an extension of the process improvement projects had to be in alignment with
improvement models, including Lean and Six the health system key result areas of Innovation
Sigma, because they employ traditional process and Strategic Growth, Productivity and Efficiency,
improvement techniques with a focus on build- Quality, and Service and Reputation.
ing a collaborative culture that incorporates Overall, Operations Councils have reduced
front line staff in the process. medication harm events, mortality, and patient
Each Operations Council identified a facilitator safety events among patients who arrive with life-
who was part of the front line staff that could dedi- threatening and difficult care issues, contributing to
Fig. 15.6 On time start improvements as a result of front to over 80 %. The number of delay minutes has dropped
line engagement. As a result of countermeasures put in from a peak of 5414 to 1347 min. Sustainability will be
place by the key stakeholders of the process in the periop- ensured by continuous monitoring and establishing
erative arena, the on time start times improved from 35 % accountability
a 22 % reduction in patient safety events across the hospital reimbursement has again changed. The
entire medical center over the past 2 years [31, 34]. Centers for Medicare & Medicaid Services
In the perioperative arena, the Operations (CMS) HVBP program now reimburses hospitals
Councils have been trying to improve on time starts. for an increasing number of patient experience
By approaching this age-old problem from the front elements, including measures of both quality and
line, surgeons and nurse engagement was assured patient satisfaction. This has led to segmentation
and facilitated the preoperative readiness, continu- of the concept of patient experience.
ous measurement and feedback, leveraged infor- For example, US healthcare systems tend to
matics support and continuous cost analysis of have a variety of departments that govern the
delays. As a result of countermeasures put in place patient experience. Although all health system
by the key stakeholders of the process in the periop- leaders are tasked to improve HVBP measures,
erative arena, the on time start times improved dra- the involvement of these different leaders per-
matically across the entire medical system from petuates the problems of a fractured health sys-
35 % to over 80 % (Fig. 15.6). The number of delay tem as each tries to maximize his or her piece of
minutes has dropped from a peak of 5414 to the reimbursement pie. Thus, although the ele-
1347 min. Sustainability will be ensured by contin- ments of patient experience may be intercon-
uous monitoring and establishing accountability. nected, the result of this varied involvement
promotes siloed thinking because of competing
priorities.
Performance Management Despite the ostensible aim of CMS to be inclu-
and Accountability sive of all elements of quality, the result of HVBP
contracts in most health systems is fragmentation
Managing the Tension of the quality goal instead of encouraging consid-
Between Quality, Efficiency, eration of a holistic patient experience.
and Patient Satisfaction The pressures of HVBP have created a tension
among the organizational priorities of safety, effi-
With the passage of the Affordable Care Act ciency, and patient satisfaction. We propose that
authorizing the use of Hospital Value-Based the solution to this problem is to incentivize a
Purchasing (HVBP) contracts, the landscape for cultural shift within healthcare systems toward
patient-centered care (PCC), possibly through success. Lastly, in as much as registry data is
including PCC measures in the CMS HVBP for- clinically validated and within the realm of sur-
mula. There is evidence that PCC improves clini- geon control, it should be used as much as possi-
cal outcomes and patient experiences, and PCC ble in the benchmarking for surgeons relative to
can be justified on the basis of a business case their peers both institutionally as well as nation-
[5]. Yet PCC requires a change in organizational ally. The level of transparency is somewhat
culture from being “provider focused” or “reim- dependent on the state in which the medical cen-
bursement focused” to “patient focused,” and this ter is found, but more transparency drives more
can only occur with the engagement of top lead- improvement in that surgeons are naturally proud
ership and a strategic vision that prioritizes PCC and competitive.
[6]. To make this change within their organiza-
tions, health system managers should focus on
improving meaningful communication between I ncentives and Compensation
patients and hospital staff, including requiring Aligned with Outcomes
staff training in PCC and communication skills.
Additionally, within the healthcare delivery sys- There are many models of incentive and com-
tem there is an opportunity and need to establish pensation and each institution will have their
patient expectations [53, 54]. own. One example of a scorecard that aligns
As healthcare organizations make the transi- institution goals with 1 and 3 year success and
tion to value from volume considerations, we assignment of responsible parties is seen in
must stay true to the core of our missions and Fig. 15.5. While the incentive model of metric
consider the many aspects of patient experience success has long been used, more CEO and
including patient safety, satisfaction, and quality. Chairmen are moving toward at-risk dollars that
By integrating and not segregating these ele- are only captured with successful attainment of
ments, we can keep in mind the true, multidi- goals [61]. Among some key top institutions,
mensional experience of patients [59, 60]. performance-based pay is more prevalent in pri-
mary care than in subspecialties, and the most
consistently identified performance domains are
ash Boarding and Bench Marking
D quality, service, productivity, and citizenship.
for Surgeons and Departments Interviewed organizations tie a relatively low
percentage of total compensation to perfor-
There are many quality and patient safety metrics mance. Procedural specialties often remained
for which surgeons can be held accountable. RVU or adjusted RVU based for all forms of
Ideally, these should be in alignment with the compensation. At the Cleveland Clinic, Mayo
institutional goals, and the targets should be set in Clinic, and Iora Health, for example, physicians
keeping with system expectations (Table 15.4). are 100 % salaried. At Group Health and Kaiser
Each division should have goals as seen in Permanente (Southern California) more than
Fig. 15.3 and then each cardiac surgeon and gen- 90 % of total physician compensation is salary.
eral surgeon should also have goals as detailed in Importantly, even organizations that tie little or
Fig. 15.4. The surgeon-specific metrics must be no compensation to performance attempted to
set in relation to his/her peers and be measured track and encourage performance on a variety of
no more than every quarter. Every surgeon should metrics by conducting internal performance
have access to his/her data and the division head reviews. Furthermore, performance data for indi-
and department Chair should attest to having vidual physicians is transparent in most systems;
reviewed them every 6 months. Surgeons should physicians are able to see their own performance
be able to help influence their metrics to which and rank, as well as that of their colleagues.
they are held accountable, and be part of the pro- At most organizations, senior leaders set over-
cess improvement projects that influence their arching strategic aims, and then work closely
with front line physicians and department chiefs ics for both quality and financial outcomes. As
to develop fair and meaningful performance met- leaders we can only influence what we can mea-
rics. Most organizations use a combination of sure; and measurement and change is the respon-
group and individual metrics to make allocation sibility of the CSQO as well as surgeon-leaders
decisions about compensation. Across large sys- who are facilitating administrative changes
tems, the most consistent performance domains needed for the healthcare of tomorrow.
are quality, service, productivity (generally mea-
sured by RVUs), and teamwork or citizenship.
Most organizations have less than 10 % of total
compensation at risk, with payments distributed uccession Planning for Quality
S
across three to five different domains, each con- Leaders
taining several metrics but that consistently
approaches with many metrics—and little at-risk Despite tremendous advances in healthcare, we
compensation for each metric offers weak incen- continue to fall short in providing the best care
tive to achieve any particular goal [61]. to surgical patients. No one surgeon can fix or
transform healthcare and we are now on a jour-
ney from systems organized around individual
surgeons to a team-based approach focused on
Future Leadership patients and families [14]. Surgeons must be
in Value-Based Care part of this revolution and engage in the shared
purpose of providing value-based care to all
Academic Development patients. Engaging surgeons in change requires
of Administrative Roles and Outcome clarification of goals and defining value-based
Researchers care—ultimately, patients must be first in the
equation. Interprofessional care should be the
Surgeons have the unique ability to influence standard to which the CSQO adheres and should
healthcare. As clinicians, innovators, and really foster the training and development of not
researchers, we can help to formulate how we only faculty but also medical students and resi-
will be measured and set forward standards to dents, so they take away the right attitudes
which we need to adhere. As such, more and towards patient care and how to get to reliable
more surgeons are taking on administrative roles, outcomes [42, 64]. The ACGME has established
both large and small, in hospitals and healthcare the Clinical Learning Environment Review
systems [63]. To that end, surgeons need basic (CLER) program as a key component of the
training in management techniques and tools, as Next Accreditation System with the aim to pro-
well as the support of leadership to enable them mote safety and quality of care by focusing on
to succeed. The time spent in administrative roles six areas important to the care in teaching hospi-
must be seen as important as in the operating tals and to the care residents will provide during
room when these surgeon-administrators are able a lifetime of practice after completion of train-
to influence the outcomes and efficiencies of a ing. The six areas encompass engagement of
healthcare environment. With the current value- residents in patient safety, quality improvement
based care transformation paradigm, the time for and care transitions, promoting appropriate resi-
change is upon us and we must train and enable dent supervision, duty hour oversight and fatigue
our future surgeons and junior faculty to not only management, and enhancing professionalism
understand the changing landscape but to also be [39, 42, 44]. With current medical student cur-
able to influence it. In addition to leadership sup- riculum development and resident requirements,
port for this new type of surgeon-leader, there the CSQO should lead by example; engaging all
must be some basic infrastructure in place in members of the team, both early and late career
every surgical department including data analyt- surgeons, so that our transformation to provide
truly value-based care is sustainable. We should medical errors in intensive care units. N Engl J Med.
2004;351(18):1838–48.
pay special attention to the learns transitions of
6. Campbell EG, Singer S, Kitch BT, Iezzoni LI, Meyer
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7. Leape LL, Berwick DM. Five years after to err is human.
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8. Liao JM, Etchegaray JM, WIliams ST, Berger DH,
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• Medical errors most often evolve as a conse-
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Information Technology
Infrastructure, Management, 16
and Implementation: The Rise
of the Emergent Clinical
Information System and the Chief
Medical Information Officer
Jon David Patrick, Paul Barach, and Ali Besiso
“We are drowning in information, while starving for wisdom. The world henceforth will
be run by synthesizers, people able to put together the right information at the right time,
think critically about it, and make important choices wisely.”
—Edward O. Wilson, Consilience: The Unity of Knowledge
to suit a particular community of users to perform

Introduction specialized tasks such as surgical scheduling,
tracking, and clinical details. These systems get
Over the past 30 years Health information tech- higher rankings from users for usability and effi-
nology (HIT) has been positioned as a battle ciency but create problems for IT departments by
between two classes of technology solutions, that requiring individual maintenance tasks for each
is Clinical Enterprise Resource Planning (CERP installed system, and silo data which is needed for
aka EMR) versus best-of-breed systems. The back office administration and analytics. In the
CERP systems are provided by the largest ven- last 10 years, the best-of-breed solution has been
dors as whole of hospital or whole of organization in retreat with the onslaught of CERP vendors
solutions intended to satisfy all users in the orga- holding sway over the decision makers with a
nization. Experience shows that they fail to fulfil promise of increased revenue for more detailed
that promise. Best-of-breed solutions are tailored billing and common access to all data [1]. At the
same time, the clinicians at the coalface of care
J.D. Patrick, PhD, MSc, Dip LS, Dip BHPsch (*) A. are complaining bitterly about CERP systems,
Besiso, MHI, BHSc which have unsuitable interfaces [1], add more
Innovative Clinical Information Management work, and fail to respond to change requests [2].
Systems (iCIMS) Pty Ltd., International Business We argue there is a distortion in the nature of
Centre, 2 Cornwallis St, Suite 4, Sydney,
NSW 2015, Australia the IT processing requirements in this current
e-mail: [email protected]; [email protected] juxtaposition, and a new paradigm of service
P. Barach, BSc, MD, MPH description and function would significantly
Clinical Professor, Children’s Cardiomyopathy improve the performance of staff and the deter-
Foundation and Kyle John Rymiszewski Research mination of the return on investment (ROI) in
Scholar, Children’s Hospital of Michigan, HIT investment and impact on patient outcomes,
Wayne State University School of Medicine,
5057 Woodward Avenue, Suite 13001, Detroit, staff satisfaction, and revenue optimization.
MI 48202, USA Understanding the value of any IT investment
e-mail: [email protected] requires identifying the usability criteria of the

248 J.D. Patrick et al.
technology, how to evaluate the usability for the which is dominated by the back-office functions
real staff users, and how to determine their of the organization. As many people have to use
improved productivity and subsequently the ROI such a system and the work is less dynamic and
[3]. In this context, we consider usability is a more static, CERP systems is the best way to sys-
general term applicable to all aspects of the tematically define this wide range of activities
acquired HIT and not the narrower sense used in such as billing and supply management enabling
user interface studies [4]. analytics across disparate collection sources of
data and fulfiling all the legal and accounting
record keeping responsibilities of large health
he Three Level Hierarchy Paradigm
T delivery organizations. The CERP has often been
for Healthcare HIT touted as a whole of organization solution with-
out accounting for variable contexts within the
We posit that there are three major levels of HIT organization. This has led to CERP solutions
services that are required in any extensive health being imposed on clinicians at the coalface of
system, and that they need to be served by differ- care with conviction from the administration that
ent technologies having different end users work- it would solve data collection and management
ing for the different outcomes. Each of these problems, but unwittingly creating much extra
levels needs to justify their rationale for a particu- work, so worsening their productivity and quality
lar type of HIT by defining their own usability of patient care [5].
requirements. Level 3. Interorganizational IT for sharing
Level 1. Departmental HIT for coal face clini- data rapidly: The whole of system needs, e.g., a
cal work: this is the context of clinical care where State health department, has to deal with usabil-
the importance of usability lies in screen real ity across multiple hospitals and organizations
estate, data flow, and workflow. The most impor- and can only assess that by enabling the collec-
tant aspect of the HIT is to support staff caring tion of standardized data across all organizations.
for the patient. For the HIT to fulfil basic usabil- Fundamentally, usability for this group is the
ity, it must support work in its most detailed way, interoperability, and their focus is about creating
that is, it must fit closely to the daily operations effective interoperability across all health institu-
of the people using it, acting like a silent col- tions in the jurisdiction. It is true that both levels
league, by never interrupting or dragging the staff 1 and 2 have an interest in interoperability, but it
away from their work, by being available to pro- neither has the core role nor the massive scale for
vide exactly what is needed easily and readily at implementation that is required at Level 3.
the moments of highest crisis. In cognitive sci- When we embrace the varied requirements at
ence terms, HIT needs to reduce the workload of these three contextual levels, we will see real pro-
data collection and analysis on providers so that ductivity emerge from HIT. Otherwise, we will
they can apply their cognitive skills to clinical continue to squander money on lofty business
management and not to user interface navigation. plans serving personal goals and making the
Crucially just as clinical practice changes, so work harder for the clinicians at the coalface of
must this Clinical Information System (CIS) be care while endangering patients.
nimble and change too; otherwise, over time it
will regress away from fulfilling the dynamic
needs of busy clinical providers. n Integrated Architecture for HIT
A
Level 2. Intra-organizational HIT for Data Usability
Management: At the hospital and whole organi-
zation context, the HIT has to support the whole In an assessment of the different requirements
of organization activities and support the sharing between the three levels of HIT, there arises a
of appropriate data across the many departments tension between usability and interoperability.
participating in the organization. The administra- The value of each of these functions to an organi-
tors are interested in whole of hospital usability, zation needs to be assessed to understand the
16 Information Technology Infrastructure, Management, and Implementation... 249
competing tensions between the 3 levels of HIT unexpected disturbances in the environment.
function and to enable a mature discussion about Consequently, adaptability and efficiency are
the trade-offs needed when making informed held to be in opposition in biological and ecologi-
choices about opting to procure significant tech- cal systems, requiring a trade-off, since both are
nology acquisitions. important factors in the success of such systems
Interoperability is undoubtedly valuable in [6]. To determine the adaptability of a process or
many settings and has proven a useful improver a system, it should be validated concerning some
in productivity. Interoperability is wanted criteria [7]. HIT is under constant scrutiny to
because clinicians want to have more reliable deliver better user interfaces and this is often
information by linking clinical care systems with couched in calls for more usability research.
ordering/results systems (pathology and radiol- There is much reference to the academic
ogy) in order to: usability research and its failure to impact deliv-
ered products from vendors [8]. While the ven-
• Interpret the patient’s condition, dors are variously reported as claiming, it is not
• Use most current, up-to-date patient records to needed or they are doing it anyway. We present
save costs on retesting, here a new way to view usability as the impor-
• Understand the decisions of prior carers in the tance of being able to adapt a system rapidly and
patient’s journey, easily. Such a technology would enable the effi-
• Avoid contradictory treatments (including cient and inexpensive means of changing a sys-
contradictory meds). tem when it is needed or a new idea of processing
or workflow is introduced. To our knowledge, it
However, interoperability has a limited effect is not recognized as part of the paradigm of
in clinical care and ROI, even though every clini- “usability” but we believe that is where it is most
cian can give an example of where it would have appropriately positioned.
helped them and it wasn’t available. How do cli-
nicians manage without interoperable systems:
(a) not badly; (b) they haven’t had it for a long Immediate Adaptability (IA)
time; (c) there is no study of the effect of not hav-
ing it but it is likely to show small results only; Most academic researchers on HIT usability and
(d) because clinicians are well trained and con- safety concede that there is little impact of this
scientious; (e) yes, they would like it but its work on vendor product design or thinking [9].
impact would be low; and, (f) yes, everyone has Furthermore, usability research at any point in
examples where it would have helped. time can become moribund or irrelevant because
But, the contribution of interoperability is not technology moves on or the context of use of the
so great that clinicians can’t do without it product changes while it is in situ, e.g., work
because: (a) its scope is very localized to indi- practice changes due to new medical practices
vidual situations; (b) the complexity of providing and government legislation. The literature of pro-
it everywhere is gigantic; (c) the co-operation fessional lists, blogs, and newsletters is replete
required from unwilling vendor partners is mon- with examples of complaints from physicians
strous; and (d) for vendors, it is a large task with that they cannot get change to their user inter-
relatively small value. faces because the vendor will not accept the
changes or it will take inordinate amounts of time
and money to complete [10].
System Adaptability We understand that vendors are reluctant to
make changes because it increases their cost of
One of the major themes across the HIT field is maintenance, potentially increases the complexity
the need for better adaptability of a feature of a of their product, and the financial reward may be
system or of a process. In ecology, adaptability insufficient [11]. While complaints about the
has been described as the ability to cope with usability of interfaces in most publications are
couched as “usability” problems that does not vulnerable to creating unexpected consequences.
address the functional behavior required of the This protest would seem to be entirely valid. It is
software and thus imposes huge cognitive loads on this very scale and complexity that inhibits
nurses and physicians [12]. What are physicians changes to “usability” beyond the minimum, not
implicitly complaining about? That the software is to mention to support IA. The best-of-breed HIT
not adaptable or what is practically the same: that system vendors have done a better job with
adaptations cannot be made immediately or within usability because they do not suffer the same
days, but remarkably takes, months, or years due complexity problem, and their aim is to deliver a
to the complex designs. In short, they are actually smaller range of functionality; however, IA
asking for “immediate adaptability” in the soft- would still be a difficult concern for them.
ware to avoid conditions that facilitate or actually The technical difficulty in delivering IA can
enable errors [13]. be discerned from the process of creating a CERP
system in the first place. The process is a sequence
of tasks consisting of requirements gathering,
Objections to Immediate systems analysis, data modeling, code writing,
Adaptability (IA) systems testing, and deployment. The CERP pro-
viders have escaped part of this process by
EMR systems built by large vendors have code removing the first two steps on the basis that they
development operations similar to Enterprise have built so many systems they know the gener-
Resource Planning (ERP) ventures like the large alizations of clinical requirements and analyses.
multinational company SAP, arguably the most Indeed, they have built large code repositories
successful ERP provider globally. We identify big relying on these generalizations and are unwill-
health vendor EMR technology as Clinical ERP ing to change them because changes will affect
(CERP). Smaller but older vendors no doubt have so many of their products and customers.
similar models. Only recent vendors appearing in Moreover, the code bases are so large that they
the last 10 years are likely to have different soft- are unwilling to risk a large number of unex-
ware approaches. The problems with IA for CERP pected consequences from changes.
are that it ostensibly requires the vendor to: The CERP approach was state-of-the-art in
the general IT industry of the 1980s, but it is now
• Give up control of the design of their CERP to outdated for most modern applications. The
the user community. method suits large volume data transactions with
• Have highly qualified programmers on call to stable patterns of work and processing such as in
respond when users require changes. banking and insurance industries, which may be
• Have built-in mechanisms to manage auto- acceptable for back office work, including health
matic version control, including roll back. organizations. This does not suit the needs of
• Have built-in mechanisms to manage data dynamic clinical workplaces where workflow is
such that data collected before a given change as important as data capture, data volumes are
remains available after the change. relatively low, local data flow and analytics are
• Change their interoperability functions on- crucial for efficiency, and staff need to run con-
demand to send and receive data from dynam- tinuous process improvement capabilities. In
ically changing EMRs. fact, imposing immutable CERPs on patient-
• Have confidence that their technology can facing clinical operations blocks processes to
undergo continuous changes. create clinical efficiencies and productivity, as is
frequently testified in the protests from clinicians
These criteria would not just increase the cost in many fora [14]. These systems encourage
to maintain CERP technology, but also raise “work-arounds,” defeating many of the HIT ben-
protests from vendors that maintaining large sys- efits and opening the door to patient harm.
tems cannot be sustained intellectually as the sys- The professional discussion lists have many
tems are too complex to change rapidly and thus conversations about how different HIT systems
need more cross-consistency because as staff or years! However, the requirements as defined by
move from one clinical site to another, they have the complaints to the professional discussion lists
an extra cognitive load to learn how to use the and elsewhere have a wider ranging scope.
many different systems leading to errors, waste of The first level of the problem is the concept of
time, and potential patient harm [15]. Training for the EMR which describes a medical record as
CERP systems is both highly costly and difficult, placed into an electronic storage bin instead of a
hence the complaints. A system optimized for IA filing cabinet. Such an EMR fits the CERP model
will be customized for its community of use and that is focused on collecting content and storing it
so staff working across multiple communities will on a large scale and then processing the data for
need to train on different IA systems. Would the highly stable requirements, e.g., billing.
same objection apply? Most likely not. CERP Furthermore, the CERP methodology requires
“solutions” that fit the local workflow poorly will deconstructing the data into normalized storage
need significant workarounds in addition to the structures of permanent definition and storage
standard training that still has to be learned by representation. In the CERP paradigm, the “effi-
migratory workers. Claims that the same technol- cient” storage of data is paramount to the pro-
ogy from the same vendor has the same workflow cesses of “capturing” the data and only then
and functions are often spurious—there are cases subsequently “reusing” the data, that is, moving
where two large systems, ostensibly the same, the data from the context in which it is collected
cannot even communicate with each other. to the contexts in which it is reused, which unfor-
Furthermore, locally designed systems custom- tunately blight the storage efficiency criterion by
ized to the needs of the clinical ecology are truly the effort and complexity of programming for the
optimal for the local workflow and so training on internal movement of the data. This involves
them is about learning how the local community elaborate methods for putting data into fixed data
actually works, surely a necessary criteria for suc- structures and reading it back out whenever it is
cessful healthcare [16]. Training on locally called for. Intrinsically, the storage mechanisms
designed systems has little training costs for local are tightly coupled with the data capture and dis-
users and modest costs for new users. Also, they play processes. As an alternative, modern web
are of significant value where senior staff respon- technologies enable a significant loosening of
sible for the training of junior staff use the IA sys- this coupling but the CERP developers have been
tem to train them in the processes of work and slow to embrace these innovations due to their
thus increase reliability and safety. years of investment in older software engineering
It is often the case that a CERP system is train- and data management methods.
ing staff in processes that are considered undesir- The greatest limitation of installed CERP sys-
able, whereas an IA system would enable the tems is the effort, cost, and risk associated with
senior staff to create an ideal training system. This changing the structures by which the data is
over time would lead to better standardization of defined and stored when a new data element
work practices where appropriate, and easier needs to be inserted into a design, or changing
adoption of these better practices as they are the semantic meaning of an existing data item.
defined by the professional community because This requires changing the underlying storage
the IT behavior is immediately adaptable [17]. design and creating the code to store that data
element and to retrieve it at all the points where
it is reused without disrupting anything of the
unctional Specifications of IA
F existing processings. The large vendors, whose
Clinical Information Systems systems have thousands of data tables that are
beyond the scope of any one person or even a
The intrinsic definition of an immediately adaptable team of engineers to comprehend, are aware that
system is in the name: immediate. We consider this their data management is brittle where even a
to be a period of hours or days, not weeks, months, single accident in a new design or coding can
bring down the entire system. This is one of the thing else. This introduces interesting questions
crucial reasons for the very strong resistance to about the protocols for naming data but stable
modifications of CERP systems. solutions are available to solve them [20].
The process of separating the captured data in IA implies real-time design, which requires a
one context, storing it in a rigid data structure, and design toolkit for specifying all the requirements
then moving it for reuse into another context is of the user including, data definition, screen lay-
fundamental to moving away from the idea of an out and behaviors, business rules, data flow, and
EMR model, towards one of a Clinical Information workflow. Underlying these design utilities is a
System (CIS). A CIS is a software technology that need to use a design language universal to all
is integrated into the processes of the users so as CIS designs that become the specification of the
to support their work in the most active and sense- operational system. This has an important conse-
making manner possible [18]. Critically, it is NOT quence: the design of the users’ system is inde-
a system that cements the processes of data col- pendent of the software that manages their data.
lection and dissemination as found in a CERP The benefit is that design can be changed with-
EMR system. A CIS matches the users require- out affecting software code, and code be changed
ments for both the flow of data from one context without necessarily effecting designs. Software
to another, and their movement through activities maintenance is done independently of any CIS
of work that the users have to perform in a seam- design processes. This radically simplifies the
less manner such as when a surgical patient is nature of system maintenance as there is no
moved from admissions to preoperative suite, enmeshment of a given system design and the
operating room, and then to the intensive care program code required to implement it. This is a
unit. A CIS supports both dataflow and workflow radical departure from present system architec-
for the user in a transparent and measurable way. ture and software engineering practice.
The third key benefit of the CIS is the physical Furthermore, it opens the door for usability
screen layout and design. The optimal design of a research to be directly incorporated into an oper-
CIS is a dominant part of clinical usability ational system. To support usability research, the
research, but, due to the nature of the CERP meth- only software engineering requirement is to have
odology, very few usability discoveries have been a library function that performs according to the
incorporated into present CERP systems [19]. usability task being investigated. If the feature to
An IA-CIS has to be easily and readily be investigated is not available in the design tool
changeable and accept real-time changes (or kit, then the only software engineering task is to
nearly so). An underlying architectural conse- enhance the design tool to carry the function as
quence of real-time changeability is that it has to an element of the design toolkit. To create an
have dynamic data structures along with revision executable instantiation of the design as defined
control that does not affect the previous versions in the design language, there needs to be libraries
of storage organization or access to previously for all design functions and auto generation of
recorded data so that real-time use is uninter- data structures that are invoked at the point of
rupted and seamless. real-time system generation.
We have named the data flow requirement of While not an absolute requirement for an
IA-CIS: native interoperability. The idea is that IA-CIS, built-in analytics are needed to achieve
data created or input at one point in a data flow the user demands in order to pursue Continuous
can be referred to by its name wherever else it Process Improvement (CPI) for clinical care [21].
needs to be reused. There should be no need to The role of using a CIS for improving direct
write code to read tables to transfer such data, but operational workflow is fundamental to its con-
rather it should behave more like a link. Thus, ception. However, optimizing the CIS over time
when you invoke the name of the data at a time requires the analysis of the behavior of the CIS
for its reuse in a new context, it appears at that and the users as an integrated entity. This analysis
point of invocation, without needing to do any- is best achieved by having analytical tools built
into the CIS that can actively monitor the CIS and We can achieve better care, more satisfied
its users to establish the value of changes as they users and less expensive outlays by repurposing
are implemented [22]. Omitting analytics func- CERP systems for back office functions and
tionality as an intrinsic part of the CIS will removing them from the clinical coalface loca-
severely limit the ability of the user team to iden- tions where IA-CIS technology can provide bet-
tify behaviors of the microsystem (staff, technol- ter support for work and better efficiency gains
ogy, equipment, etc.) that warrant change and for the relative costs of installing them.
later to measure those changes. Customization of IA-CIS is the most likely path-
way for reducing workarounds, but with the more
important positive benefits of increasing data col-
Generic Architecture for IA-CIS:
A lection completeness, improving patient safety,
Repurposing the EMR Model enabling cultures of continuous process improve-
ment, and, of course, both simplifying and accel-
The IA-CIS methodology is in some ways a erating training [23].
counter positive to the CERP. Over time, the An important extension to the IA-CIS is that it
CERP methodology has diminished the role of is a coherent method for creating a single appli-
requirements gathering and systems analysis to cation for one clinical department that can be
the point, where it serves only to direct system repeated for many clinical departments in the
configuration of fixed data structures and con- organization. Although each department designs
comitant code bases. IA-CIS does the opposite: it their own system as an autonomous community,
treats requirements and design as the primary they all use the same design tools and the same
function of creating a system for the specific instantiation library; hence, the technical imple-
needs of the user community. It then generates an mentation can house them all in the same soft-
implementation process from the choices defined ware installation. This is equivalent to providing
in the design, creating dynamic storage structures multiple customized best-of-breed systems in the
served by an engineered library of adaptabilities. one software installation. This architecture intro-
The value of CERP-engineered systems lies in duces a different type of interoperability, that is,
their capacity to massage large volumes of data CIS to CIS by means of within-system native
for repetitive, infrequently changing processing. interoperability. So while users are operating
The disadvantage is their inability to satisfy the under the belief they are autonomous, they are
needs for representing intricate and different actually all working within one infrastructure
workflows in multiple clinical contexts. Although with a single data management process that
all clinical contexts are ostensibly the same, actu- enables the direct sharing of data (given the
ally they are steeped in subtle and significant dif- appropriate permissions) and introduces an inher-
ferences both between medical specialties and ent cohesion that is not part of the consciousness
across institutional contexts, with the added com- of the different user communities but neverthe-
plication of fast-changing and diverse work that less enables interoperability at a subliminal level.
needs to adapt practices immediately for any Figure 16.1 is a high-level diagram showing mul-
number of social, legislative, or professional rea- tiple systems including clinical care, research,
sons. Using an IA-CIS for clinical care systems and registry systems built on the one software
will reduce the maintenance load on the CERP so platform using native interoperability to share
they don’t have to be continually adaptable and data with each other and a single gateway to com-
hence will lower the costs of managing them. The municate with external systems.
CERP will contribute better to the HIT ecology if IA-CIS do not solve the problems of interop-
it is rightly positioned as the data warehouse erability between different systems supplied by
backbone of the organization fed by the highly various vendors. Hence, it is unavoidable that a
efficient limbs manifest as IA-CISs. CERP system and an IA-CIS will have to use
Fig. 16.1 An architectural diagram of the relationship between clinical care information systems and clinical research
systems and registries as part of the ECIS paradigm
some external coding standard to share data people who collect it, and then appropriate
between each other. Methods for solving this selected pieces passed on to those who have sec-
problem are well established by HL7 or ODBC ondary use purposes. Just as the results of every
direct procedure calls. (ODBC Direct is an alter- research experiment are not required by the back
nate mode of Data Access Objects (DAO) that office so not every action taken by the clinical
accesses ODBC data sources directly, and taking staff needs to be defined by the back office.
full advantage of the remote data source’s pro- Autonomy at the front office with a requirement
cessing capabilities.) But within the IA-CIS para- to deliver the essentials to the back office
digm, the problem is solved at a much more enhances the efficiency of both communities.
efficient level by native interoperability. There is an argument in some circles that there
The IA-CIS also has another significant needs to be a single source of truth which can
advantage in that it eliminates silos of data, and only be provided by a CERP. This is a false
maintenance and support for multiple systems. In assertion when it is claimed. The extensive dis-
this data architecture, it is important not to take a persion of a complex care process delivered by
stance that assumes all data needs to be available many disciplines with many different technolo-
in one place. Most data needs to be usable by the gies has already led to an irreversible distribution
of data across multiple information systems, such improvement. Intra-interoperability with other
as surgery, radiology, pathology, and pharmacy. non-service clinical departments is useful but
Advocates for this position, who already operate not essential in that it enables in-hospital
multiple systems successfully, use this as an information to be provided in a more amena-
argument to exclude evaluating the local systems ble manner, but the care of patients will con-
value. The solution proposed here is to ensure tinue regardless of its absence.
that local systems have appropriate interoperabil- Feature 2. Intra-interoperability between spe-
ity and support. cialty clinical systems and service clinical
The imposition of inefficient and burdensome departments for the Level 1 context is useful
HIT in clinical workers has led to a Stockholm- so that the normal operational care of patients
like syndrome and worse such as: can run smoothly with the service disciplines
“It is well understood in psychology that when which service many of specialties with the
people repeatedly experience unpleasant events same service functions such as pathology,
over which they have no control, they will not only imaging, and pharmacy. This local intra-
experience trauma, but will come to act as if they interoperability has for the most part been
believe that it is not possible to exercise control
over any situation—indeed, that whatever they do solved by the use of certain standards such as
is largely futile. Attempts to remedy the opera- HL7 messaging and DICOM picture stan-
tional and social disadvantage of clinicians sub- dards. Immediate adaptability has not been
jected to inefficient systems depends, strongly advocated by the service clinical
fundamentally, on understanding the effects of past
trauma and its potentially cumulative effects.” [24] departments, probably because of the more
routine nature of their work and smaller extent
In summary to which the information system capabilities
effect their work processes.
• Front-line staff productivity will make greater Feature 3. Analytics is an important function at
gains from immediate adaptability than each of the levels of HIT context, but it is a dif-
interoperability, ferent type of analytics for each. Clinical care
• Organizations will better protect patients with units need analytics to understand the statistical
immediate adaptability technology, profile of their operational activities, while a
• Interoperability, CERP, and best-of-breed sys- health organization needs analytics to under-
tems each represent usability at different types stand the trends of activities aggregated over
of context, and multiple units of activity, that is, what is com-
• ROI needs to be interpreted and assessed at mon between each of their different clinical
their appropriate context, and efforts to con- units. They also have to investigate the relation-
flate them into alternative competitive solu- ships between the costing of activities and the
tions is a misunderstanding of their different resources they put into those activities. Finally,
contributions. they need to develop models of future activities
to support resource planning and allocation.
Feature 4. Inter-interoperability requires the shar-
An Architecture That Supports ing of data within a large Level 3 organization
the Levels of HIT Context such as a multihospital organization or a state
or provincial government with many disparate
A data architecture to satisfy all the requirements health services. These organizations are domi-
of the three levels of health organizations has to nated by the effort at getting data it can stan-
have these features: dardize for predictive analytics and to identify
both acute and long-term health trends, in the
Feature 1. Immediate adaptability for the Level 1 first case to react to public health scares, and
context so that patient-facing clinicians can in the latter case to plan the delivery of health
work within a paradigm of continuous process resources at a society wide scale. These orga-
nizations reduce the health organizations data in the past have used best-of-breed solutions but
to a “common data set” of limited dimensions, now are being swept into the EMR vortex.
as it is too difficult to get data from many dif- Crucially, when they are drawn into an EMR
ferent types of health organizations to do any- solution, they lose the ability to have the system
thing that might be more reliable. The adapted to their needs, and they are provided
interoperability problem at this level is much with workflows that predominantly make their
greater than at the intra-level because there is work less efficient, require more manpower, and
a large number of organizations to deal with lead to much pushback.
and so the complexity of the task is exponen- Effectively, the work of a data warehouse is
tially larger than at the intra-level. Adaptability being harnessed to serve the work of a dynamic
of clinical information systems is of little con- workplace with shifting practices, workforce,
sequence at this level because they are only and demands on the capacity to adapt and change.
dealing with a synthesis of data collected from The need for a CCIS solution is readily defined in
many diverse settings. Often this is the level at a few criteria: Immediate adaptability (and hence
which HIT acquisitions are determined and near real-time adaptation), user-controlled
hence the success of CERP vendors who design, native (in-built) interoperability, and in-
appeal to the HIT problem at this level. built analytics. The software engineering solution
for these criteria produces a very different type of
We are advocating for a new architectural architecture that creates the optimal blending of
configuration that embodies methods for tackling function of levels 1 and 2 systems while over-
these problems. The inherent notion is to change coming most of the drawbacks.
the common architecture of the Level 2 context The software architecture as explained below
so that it has the benefits of the Level 1 architec- has been implemented after a number years of
ture without its drawbacks for Level 2, and the experimentation and has demonstrated the pro-
benefits for the Level 2 context without the disad- posed benefits are real. Underneath these four
vantages it creates for the Level 1 users. criteria is a key architectural requirement that the
Conceptually, this requires a shift to a new view- means of designing such systems has to be sys-
point of CIS architecture in that it inserts the temized [25]. The architecture has at its kernel a
ideas of immediate adaptability, user-controlled design tool that enables a user to create a design
design, native interoperability, and in-built ana- of an information system, this includes screen
lytics into the debate and aligns those ideas with design, data flow design, and workflow design.
the established technology of data warehousing. The design is maintained internally in a design
database in the form of a design language. Adding
new design functions requires adding the capa-
he Architecture in Practice:
T bility of describing them to the design team and
Clinical Care Information Systems developing a formal method of expressing them
(CCIS) and Clinical Services in the design language. Then, the library code
Information Systems (CSIS) needs to be written which is invoked on calling
the feature in a particular CIS. The data modeling
We define two classes of health information function is managed internally by the software
technology (HIT): Clinical care information and is not available for the user to be concerned
systems (CCIS) and clinical services informa- with or to tamper with. It is a basically an object-
tion systems (CSIS). The CSIS are systems orientated strategy using relational stores for the
required by most of the clinical departments in a management process. The critical objects are the
hospital setting such as surgery, pathology, radi- screens or forms into which is embedded the
ology, pharmacy, and EMR. The CCIS are the dataflow, workflow, data management, and busi-
systems required by the clinical specialties that ness rules.
Fig. 16.2 ECIS architecture supporting a variety of clinical information systems within its own paradigm
Years of work since the original publication over time. This in effect enables a system to be
have solved many of the technical problems and not only a mechanism for experimental design
demonstrated that a feasible and practicable with a roll back that can be executed at any
solution can be achieved. Figure 16.2 displays time, but also a strategy for incremental devel-
the basic engineering architecture for creating opment where after completing and operation-
multiple CISs in the one software environment alizing one subsystem the next most suitable
and the access to the data via APIs, HL7 mes- subsystem can be chosen for implementation.
saging, and a clinical data analytics language Property 2. Multisystem design on the one soft-
(CLINIDAL). ware platform: With a functionality to
There are some interesting emergent proper- continuously expand one system, it is entirely
ties from this approach that strengthens its possible to create a different clinical system
merits: on the same platform. There are an unlimited
number of CISs that can be created and oper-
Property 1. Painless expansion and incremental ate from the one software installation. So
design: Firstly, a system runs by invoking the although this architecture is a pseudo-best-of-
design which is executed by a library function. breed technology, it is also a multi-best-of-
A system that is defined entirely by the act of breed solution, effectively allowing users to
design intrinsically means that only the design create systems as if they are wholly autono-
has to be changed to create a new function in mous, but all the while the underlying infra-
the CIS. Subsequently, a design can be pre- structure is using the same code and data
pared to cover a minimally necessary amount management strategies behaving like an enter-
of workflow and then be added to regularly prise architecture.
Property 3. User-controlled design: It is an and the software team does not have the work-
advancement on user-directed design that load of understanding or managing the system
enables the user to specify exactly the design design. They are only required to ensure the
they want. It is often the case that users don’t code computes correctly.
understand what they really want until after
they have been disillusioned by being deliv- Figure 16.3 demonstrates the manner in which
ered something they thought they wanted. the EMR can be repurposed as a data warehouse
With real-time adaptation, the user can experi- and the clinical care and clinical services can ful-
ment with designs to their own knowledge fil their own roles while delivering information to
depth and revert to older designs if new ones each other and to the EMR as each needs.
are proven to be non-optimum. This technology supports a methodology for
Property 4. Rapid prototyping: The ability to mod- creating user designs with an incremental itera-
ify implementations at will means that proto- tive feedback process. We denote the underlying
types can be built rapidly, tested, adapted, and architecture, as Emergent Clinical Information
generally system development be progressed at a Systems (ECIS), which automatically uses a pre-
faster rate than other technologies. defined run-time library of code to directly exe-
Property 5. Automatic version control: The cute the user designs; hence, no programming is
design is implemented in such a way that it required to move from design to implementation.
stores all versions of all designs; this includes The ECIS architecture is defined on the principle
screen designs, embedded business rules, data of Ockham’s Razor of Design, i.e., the principle
flows, and workflows. Hence, all version con- that simplicity is preferred to complexity in
trol is an in-built feature of the design tool, design, so that given the choice between func-
and reversion back to an earlier version of the tionally and simplicity, simplicity will always
system can be achieved by just nominating the take higher consideration. In the ECIS, this
version number. means that the elements of design that are engi-
Property 6. Universal data storage: Because all neered for the designer are a minimum number of
CISs built within this paradigm use the same design objects with maximal generalization [25].
design language and storage management The CIS design is created by a principle of Agile
functions they all use the same data storage to Design where designs are created and tested
preserve patient data. Hence, all systems have incrementally within an iterative process.
access to all other systems data provided With this functionality, the capacity to make
appropriate permissions are set. near real-time adaptation of an implementation
Property 7. Universal attribute coding: To ensure is made available, giving enormous power to the
that data elements can be semantically shared design team to explore alternative designs before
the system has a mechanism for identifying a commissioning a specific implementation. At
variable by its SNOMED CT concept identi- the same time, the underlying data management
fier, or any other useful data standard the user for all CISs built in the ECIS paradigm is the
wishes. In this way, the semantics of data same, and hence it has the unification of the code
fields between systems is well defined making base and data stores in a single application. In
data sharing much more reliable. essence, it is a best-of-breed solution on the user
Property 8. Radically reduced maintenance: An side and an enterprise system on the server side.
interesting emergent property of this paradigm The ECIS model with user-controlled design,
is the significantly reduced software mainte- real-time changeability, native interoperability
nance required for the installed software. This to move data from the collection process to
approach effectively separates the process of where it has to be reused, and in-built analytics
CIS design from the preparation of executable to monitor the effect of change represents a
program code. The design is the responsibility much superior approach to providing effective
of the clinical team and the software that of the methods for Clinical Process Improvement (CPI)
software team. There is very limited overlap in any clinical setting.
Fig. 16.3 An ECIS configuration with an external EMR acting as a data warehouse and other clinical service informa-
tion systems (CCIS)
Case Study Results 1. Assess the capacity of staff to design their

own CIS;
The system development approach espoused in 2. Assess the capacity of the ECIS technology
this chapter has been tested in a practical setting used for the design process to satisfy all the
with the development of a number of oncology demands of the design team;
systems but by far the largest is an Emergency 3. Assess the differences between the NEDIMS
Department Information System (EDIS) at and the CERP for:
Nepean Hospital, NSW, Australia. A prototype (a) Efficiency of operation;
of the idealized technology was built and subse- (b) Cognitive load;
quently the ED staff created their ideal design 4. Assess the effect of the clinicians’ design on:
for an EDIS that was optimized for their envi- (a) Workarounds;
ronment. The system was denoted as Nepean (b) Paper processes;
Emergency Department Information 5. Assess the trainability of NEDIMS;
Management System (NEDIMS). NEDIMS per- 6. Build a model of patient journeys and assess it
formance was compared to the incumbent for differences between NEDIMS and the
CERP, from one of the large international EMR CERP for that model;
providers. A full report on the project has been 7. Identify the processes of interruptions and

prepared and is available on request [26], and consider methods for minimizing them;
some of the results most pertinent to emergency 8. Make a qualitative assessment of the differ-
medicine have been published [27] which is ences between the two systems for patient
followed by an editorial on the merits of the safety, staff productivity, and clinical audit;
technological approach [28]. 9. Assess the costs and ease of modifying the
The evaluation of the NEDIMS system had system and provide an evaluation of the ROI
these objectives: in making those changes.
A process analysis for each of the six activity nal and switched accounts. The first user contin-
centers in the ED is described: Clerking, Triage, ues entering data into a patient record without
CIN (Clinical Initiatives Nurse), Fast Track, realizing they are working under the name of a
Acute Care, and Nurse Unit Manager (NUM). different staff member, which becomes apparent
The process analysis formed the basis of under- when they have to try to save and commit the
standing the design needs of the department. It record and they do not have the password of the
was also used subsequently to identify the task logged on user. As a result, they sometimes need
types that needed to be used in the quantitative to redo potentially long tasks such as ordering
comparison between the two systems. A total of tests after restarting the system with their own
43 task types were identified of which 27 were credentials. NEDIMS implemented a validation
present in the CERP system, 40 were present in step of “signing off” that allowed switching
NEDIMS and 14 were completed on paper. accounts seamlessly.
The department staff were observed for 22 days A model of patient journey through the depart-
where each task instance was measured for time ment consisted of four scenarios of short and
duration and number of mouse clicks in live usage long Fast Track patients and short and long acute
on the CERP and paper forms. A total of 722 task care patients in a proportional ratio of
instances were recorded from 43 task types. 15:15:30:30. The resulting analysis showed that
Subsequently, 374 matched observations of 17 task NEDIMS would provide a staff time saving of on
types were measured for those tasks that could be average 23.9 h per day [26].
repeated in NEDIMS of which 332 were matched A qualitative analysis of opinions from staff
task instances between NEDIMS and the CERP, comparing the two systems on three key perfor-
the remainder being matched to paper forms. mance criteria of patient safety, staff productiv-
The results demonstrated that NEDIMS is ity, and clinical audit over 19 tasks, giving a total
about 40 % more efficient than the CERP using of 57 cases. It showed NEDIMS was ranked
directly measured times and on normalized higher on 39 cases, the CERP for two cases; the
results greater than 50 % more efficient [26]. two systems were equal for 15 cases and one case
NEDIMS was better on 14 out of 16 tasks for non-determinable.
time costs of which 7 were statistically signifi- The time cost of the effort in remodeling the
cant for NEDIMS and 2 were significantly better designs showed that the time-savings were
for the CERP. returned within a few days to a week of opera-
The cognitive load, as represented by click tions in the department; hence, the return-on-
counts, showed that NEDIMS significantly investment indicates a high yield under the ECIS
reduced the cognitive load on users by up to 30 % methodology. The total cost of designing and
overall. In 9 out of 16 tasks, the NEDIMS testing NEDIMS amounted to about 140 person
required fewer clicks to get the same job done, of days, which will be regained by the department
which 5 were statistically significant with 5 sig- after about 50 days of operations.
nificantly fewer for the CERP. Finally, here is the conversation that trans-
A number of workarounds discovered in the pired between the process analyst who helped
process analysis phase of the research were iden- install a cancer CIS using this technology and
tified and the efforts to eliminate or minimize clinical staff at the St. George Hospital, Sydney, a
them in NEDIMS revolved around the current sister hospital to Nepean Hospital in New South
workflow processes of the department. For Wales, Australia, about the impact of the ECIS
instance, terminals were used by multiple staff methodology in supporting their EMR needs:
but they often would leave the terminal due to Senior Nurse: “I am the worst person in the unit
interruptions or to collect other information. for IT, I know nothing about it and if anything will
When they return to the terminal, they assume go wrong it will happen with me.”
that the current session is under their own account Process Analyst: “I spent a lot longer than I
would normally explaining the system, about
when in fact, in the time of their absence from the 10–12 minutes then I got her to go through the
terminal, another staff member needed the termi- whole system and there was not one problem.”
Subsequently after system testing Senior engagement [29]. Hence, the ECIS model is a
Nurse, “you know I think it is so good I could have
new paradigm, a credible alternative to a large-
gone through the whole system without your help.
This is great because it is just the way we imagined scale sudden-death system changeover using
it would be and it is exactly the way we work.” many foreign, impractical workflows. It capital-
izes on local knowledge and wisdom, flexible
work practices and heuristics, and optimizes the
local environment in contrast to clunky, slow
onclusions and Some
C moving enterprise solutions.
Observations About the Future The ECIS technology enables a new HIT
of HIT architecture that propels the needs of the
patient-facing staff to the forefront of the HIT,
Engaging and supporting clinical staff in the which can bring significant advantages in effi-
design and testing processes of HIT, in a man- ciency and ROI for health organizations as
ner that reflects their local workflow processes, well as enhancing workplace satisfaction. The
ensures it is better suited to their needs and will shifting of emphasis on the role and function
be a better aid to their work than an incumbent of HIT requires a shift in perceptions on how
CERP system. Information systems designed to utilize whole-of-organizations CERP instal-
for and by a clinical team using a technology lations. This means being thought of more as a
that enables real-time adaptation provides much data warehouse, something that such systems
greater efficiency for the staff in decreasing the are more akin to and can serve better the needs
time to complete standard tasks. Additionally, of organizational infrastructure.
it creates a continuous process improvement
environment that enables the workflow pro-
cesses to be adapted dynamically to optimize
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Redesigning Hospital Alarms
for Reliable and Safe Care 17
Paul Barach and Juan A. Sanchez
“Even the boy who cried wolf was right about the wolf once.”
—Sherry Thomas
agement; these numbers are likely to be underes-

Introduction timates.1 Many factors contribute to alarm
fatigue, but perhaps most significant is a reported
Noise levels in hospitals have been rising for false alarm rate of as high as 90 % among mil-
decades and are far higher than guideline values lions of alarm signals. These large numbers of
established by the World Health Organization. clinically irrelevant signals directly contribute to
Alarms contribute significantly to noise pollution staff desensitization. In addition, high back-
in healthcare facilities. Alarm safety is one of ground noise levels in critical care and variable
healthcare’s most high-profile and intractable acuity units and in operating rooms contribute to
problems. A phenomenon known as “alarm alarm response failures. They do this by further
fatigue,” including limited capacity to identify increasing the cognitive load on staff; escalating
and prioritize alarm signals, has led to delayed or distraction and irritability; and complicating dis-
failed alarm responses and deliberate alarm deac- cernment, attribution, and communication.
tivations. Alarm fatigue has been implicated, If, however, alarms are intended to maintain a
according to federal agency reports as well as in level of situational awareness, designers need to
the lay press, in patient morbidity and deaths, engineer monitoring devices able to do some or all
some highly publicized. Between 200 and 566 of the following: distinguish artifact from real patient
patient deaths have been reported to have died status changes, determine whether these changes are
from 2005 to 2014 as a result of alarm misman- contextually important, convey the source of the
alarm to the receiver, and allow prioritization when
P. Barach, BSc, MD, MPH (*) operational attention is directed elsewhere (e.g., dur-
Clinical Professor, Children’s Cardiomyopathy ing line placement) or when multiple alarms sound.
Foundation and Kyle John Rymiszewski Research Multiple levels of influence and opportunities
Wayne State University School of Medicine, for system intervention and innovation exist to
5057 Woodward Avenue, Suite 13001, Detroit, facilitate timely and reliable alarm responses.
MI 48202, USA These include addressing the broader acoustic con-
e-mail: [email protected] text, clinician responsibility, deployment and
J.A. Sanchez, MD, MPA
Department of Surgery, Ascension Saint Agnes
Hospital, Armstrong Institute for Patient Safety & 1
ECRI Institute. ECRI Institute releases top 10 health
Quality, Johns Hopkins University School of Medicine, technology hazards report for 2014. November 4, 2013.
Baltimore, MD, USA https://www.ecri.org/Press/Pages/2014_Top_Ten_
e-mail: [email protected] Hazards.aspx Accessed January 3, 2014.

264 P. Barach and J.A. Sanchez
teamwork training, threshold-setting guidelines, Organization (WHO) established hospital noise

improved user interfaces, and algorithms balancing guidelines in the 1999 publication “Guidelines
alarm specificity with sensitivity. Monitoring for Community Noise” to better understand and
devices that process complex data streams should address the negative effects of noise, stating that
produce clinically relevant alarm signals in an envi- perception of sounds is of major importance for
ronment which is optimized for discernment and human wellness [2]. According to WHO, excess
attribution and with user interfaces designed for noise can result in impairment of functional
timely interpretation, prioritization, and prompt capacity or an impairment of capacity to com-
action. Hospitals need a system-wide alarm pensate for stress. The WHO recommended a
management policy and protocols that define the hospital sound level maximum (Lmax) of 40
alarm management strategy for alarmed medical decibels (dB) and 35 dB for patient rooms.
equipment, and delineate how caregivers/nurses Current hospital noise levels significantly exceed
should respond to alarm conditions and signals.2 these numbers by an average of 30–40 dB [3].
Involving patients in the redesign of hospital acous- Hospitals historically have not conformed to rec-
tic environments may also improve patient experi- ommended or legislated sound levels [4]. It is not
ences and satisfaction with their hospital care. unusual for Emergency Departments, operating
rooms (ORs), and intensive care units (ICUs) to
have average noise levels in the 73–77 dB range
he Detrimental Impact of Noise
T with paging and surgical equipment producing
and Alarms on Patients and Providers intermittent noise spikes of over 90 dB [5, 6].
Consequently, noise in healthcare environments
Noise and sound characteristics have been demon- is becoming recognized as a serious health issue,
strate to negatively impact both patients and clini- increasing staff stress and absenteeism, hindering
cians. In the 150 years since Florence Nightingale patient healing, and causing patient injury and
wrote about the adverse effects of noise on hospi- even death [7, 8].
tal patients, others have noted the problem, but it is A growing body of research about the harmful
still not recognized as a major cause of harm. effects of noise in the healthcare environment
Hospital noise is considered pandemic, dan- along with the new financial and regulatory
gerous, annoying, and consistently leads to the incentives has advanced noise control in health-
lowest average HCAPHS (Hospital Consumer care facilities to a top priority. High noise levels
Assessment of Healthcare Providers and in trauma units can also detrimentally affect
Systems) scores and is the lead patient safety short-term memory tasks, mask task-related cues,
goal for the National Patient Safety Foundation impair auditory vigilance (for instance, the abil-
and The Joint Commission.3 Critical, and less ity to detect and identify alarms), and cause dis-
well understood or appreciated, is that the quality tractions during critical periods [9]. A review of
(characteristics) of the physical environment of the literature by Ulrich et al. found more than
sound, more than simply its volume (collectively, 1200 studies linking the physical environment to
the “soundscape”), is significantly detrimental to patient and staff outcomes in areas of stress,
the delivery of medical care and the well-being of fatigue, patient safety, outcomes, costs, and over-
both medical staff and patients. It directly con- all healthcare quality [10]. Dickerman et al. also
tributes to medical error and patient harm. found a direct link between patient care quality,
Hospital noise routinely exceeds international patient health outcomes, and hospital design,
WHO noise acceptable standards and is more supporting the link between hospital environ-
than just an annoyance [1]. The World Health ments as a promoter of stress for patients and
staff [11].
2
See Johns Hopkins Hospitals clinical alarm management Poor acoustic clinical environments are also
policy http://hpo.johnshopkins.edu/hopkins/policies/39/ associated with an excessive cognitive load on
11305/policy_11305.pdf?_=0.231088243942. clinicians [12] and interference with speech and
3
http://www.jointcommission.org/assets/1/18/jcp0713_
communication, both of which can increase the
announce_new_nspg.pdf.
17 Redesigning Hospital Alarms for Reliable and Safe Care 265
risk of medical errors and patient harm [13, 14]. relations, and optimal decision integrity [22].
As an example, alarm fatigue, the clinician More studies to understand these ill effects will
desensitization to incessantly beeping alarms require transdisciplinary work using more sophis-
amounting to hundreds of alerts a day (up to 90 % ticated methods, tools, and techniques.
false or not relevant) is a national problem blamed Like many innovations, alarms were first
for dozens of deaths each year, as overwhelmed developed as safety devices for an exceedingly
staff do not respond or fail to respond with small group of high-risk patients. Because clini-
urgency [15]. Caregivers must exert greater effort cal events and hemodynamic alterations often
to maintain accuracy which, in turn, increases presage harm in this population, alarms have
physiological responses and fatigue [16]. Busch- been highly successful at averting complications.
Vishniac found noise levels at John Hopkins Encouraged by these benefits, the medical com-
University Hospital were high enough to affect munity expanded this model to lower risk popu-
speech comprehension (speech intelligibility) lations. Moreover, innovations in bioengineering
[1]. Reduction in speech comprehension is also and computer science have successfully embed-
known to increase performance errors. Murthy ded all types of alarms into an expanding portfo-
and Rataplan found noise levels interfered with lio of physiologic monitoring equipment with
attending and resident interactions in more than a variable impact on patient care. The consequence
third of shift-change communication [6, 17]. of this well-intentioned technological evolution
Excessive noise levels can induce and exacerbate and generalization is epitomized in the din of
anger, annoyance, displeasure, and staff burnout chirps, beeps, bells, and gongs that typify hospi-
[18]. Excessive noise is a stressor to both patients tals today. It is, thus, not surprising that concerns
and staff. While researchers have noted improved regarding safety have emerged, even in popula-
patient outcomes and staff satisfaction in hospi- tions for whom these protective devices were
tals with perceived good acoustic environments, once considered most valuable.
the reverse has also been demonstrated [19, 20].
Babisch’s work illuminates the physiological
effect of the noise–stress relationship. The impact haracteristics of Systems and Risk
C
of noise on medical errors and patient harm is Management Framework
summarized in Table 17.1 [21].
In addition to documented cardiovascular A surgical healthcare system includes several
responses to stress, there are long-term health subcomponents. Foremost among these are those
effects for individuals exposed to noisy environ- surgical or clinical processes, which are used to
ments. Excessive noise causes problems with treat patients directly. Another component is tech-
concentration, fatigue, uncertainty and lack of nology, medical and nonmedical including infor-
self-confidence, irritation, misunderstandings, mation systems, diagnostic systems, imaging
decreased working capacity, problems in human systems, as well as mundane technologies such as
floor cleaning equipment, supply ordering, and
distribution technologies [23]. Additionally, there
Table 17.1 Impact of noisy healthcare facilities on is organization, the administrative arrangement
patients and providers that includes policies, procedures, strategies and
Medical errors tactics, management tools, business plans, etc.
Impaired communication and concentration Providers are another subsystem. They include
Disorientation and distraction professional, technical, administrative, manage-
Elevated blood pressure and stress levels ment, patient, public, government, and others.
Auditory habituation or ear fatigue Finally, there is the physical environment includ-
Rule breaking behaviors (such as turning off alarms) ing the architecture, engineering, interior design,
Sleep disruption and loss of sleep that is essential for and other environmental conditions which, in
healthy recovery aggregate, impact a large number of organiza-
Startle response tional characteristics [24].
Charles Perrow studied major accidents and technology [28]. These “performance shaping
discovered that systems, rather than individuals, factors” must be understood and incorporated in
were often at fault [25]. Perrow and James alarm design to enhance provider responsiveness
Reason have redefined how we should under- [29]. For example, current medical device inter-
stand the causes of accidents and how we fix faces should be able to minimize false alarms pro-
problems [26]. One of Perrow’s contributions duced by irrelevant signals such as patient
was to describe how the components of systems repositioning, suctioning, and oral care, which
are interrelated. He defined two dimensions, can alter heart and respiratory rates, as well as dis-
complexity and coupling, which predict how sys- locating sensors.
tems function. There are many other subcompo- Human factors research is of great relevance
nents of systems, some of which are hidden, and in designing spaces for managing surgical
require “operators” to use a great deal of short- patients and intensive care patients [30] and in
term memory, cognitive work, or computing considering the impact of the many “perfor-
power. The planning, designing, and construction mance shaping factors” that can degrade
of healthcare facilities involve physical structures human capabilities (Table 17.2). One of the
and processes that are tightly coupled in that most important decision-making skills by
there is no “wiggle room” in the connections. If healthcare teams is to decide which sources of
one component fails, the adjoining components streaming information to devote attention to
are immediately impacted, sometimes in unfore- and what can wait. Where data overload is the
seen ways. rule and the patient’s status changes continu-
Noise engineers and medical personnel generally, the ability to recognize clinical cues
ally have been working separately on noise quickly and completely, to detect patterns, and
issues, with limited progress and implementation to set aside distracting or unimportant data can
of their findings. With increased urgency for be lifesaving. Situation awareness (or situation
quality and performance improvement, multidis- assessment) is a comprehensive and coherent
ciplinary teams have been formed to produce representation of the (patient’s) current state
actionable research and evidence-based design that is continuously updated based on repeti-
initiatives [27]. This collaboration between medi- tive assessment [31].
cine and engineering has produced data on physi- Situation awareness appears to be an essential
ological responses, healthcare outcomes, and prerequisite for the safe operation of any c omplex
economic impact, which have considerable influ- dynamic system. In the case of healthcare, estab-
ence on policies relating to noise, in contrast with lishing and maintaining a “mental model” of the
the historic assumption that noise is nothing more acute patient and the surrounding environment
than an annoyance. including facilities, equipment, and personnel are
essential elements to effective situational aware-
ness [32]. Successful team situational awareness
uman Factors and Situation
H requires constant communication that enables
Awareness in Understanding members to converge around a shared mental
Optimal Alarm Management model of the situation and a course of action to
quickly correct course as needed. Effective teams
Human factors (also known as ergonomics) is the adapt to changes in task requirements, anticipate
study of human interactions with tools, devices, each other’s actions and needs, monitor the
and systems with the goal of enhancing safety, team’s ongoing performance, and offer construc-
efficiency, user satisfaction, interpretability, and tive feedback to other team members [33]. When
ease of action [9]. Nearly half a century of team members share a common mental model of
research and hands-on experience have produced the team’s ongoing activities, each may “instinc-
a substantial body of scientific knowledge about tively” know what each of their teammates will
how people interact with each other and with do next (and why) and often communicate their
Table 17.2 Performance shaping factors affecting surgical carea

Individual factors Clinical knowledge, skills, and abilities
Cognitive biases
Risk preference
State of health
Fatigue (including sleep deprivation, circadian)
Task factors Task distribution
Task demands
Workload
Job burnout
Shiftwork
Team/communication Teamwork/team dynamics
Interpersonal communication (clinician–clinician/
clinician/patient)
Interpersonal influence
Groupthink
Environment of care Noise
Lighting
Temperature and humidity
Motion and vibration
Physical constraints (e.g., crowding)
Distractions
Equipment/tools Device usability
Alarms and warnings
Automation
Maintenance and obsolescence
Protective gear
Organizational/cultural Production pressure
Culture of safety (vs. efficiency)
Policies procedures documentation requirements
Staffing cross coverage
Hierarchical structure
Reimbursement policies
Training programs
a
Modified from Barach, P., Weinger, M. Trauma Team Performance. In: Trauma: Emergency Resuscitation and
Perioperative Anesthesia Management., Vol 1, Wilson, W. C., Grande, C.M. Hoyt, D.B. (Eds.), Marcel Dekker, Inc.
2007, 101–113. NY. ISBN: 10-0-8247-2916-6
intentions and needs nonverbally (sometimes ous injury or death. Physiologic monitors, ventila-
referred to as implicit communication) [34]. tors, infusion pumps, and many other medical
devices contain clinical alarms to alert caregivers
to critical events and to keep patients safe [36].
Medical Device Features Monitoring devices that process complex data
streams should produce clinically relevant alarm
Medical device alarms are deliberately designed to signals in environments optimized for discern-
alert attention [35]. They can make the difference ment and attribution and contain user interfaces
between timely, lifesaving interventions, and seri- designed for timely interpretation, prioritization,
and prompt action. Addressing alarm fatigue stance that results in the failure of staff (1) to be
requires that regulators, manufacturers, and clini- informed of a valid alarm condition in a timely
cal leaders recognize the importance and context manner, or (2) to take appropriate action in
of human factors and staff behavior, with design response to the alarm, can be considered a clini-
and evaluation of devices accomplished through cal alarm hazard [44].
clinical simulations [37]. In simulations, how- Improving the acoustic environments for hos-
ever, most of the noises are false alarms or don’t pitalized patients can have significant positive
require action [38]. The ventilator sounds a warn- effects on patients including decrease rehospital-
ing because a patient coughs. The infusion pump ization rates, improve sympathetic arousal in
beeps after running out of a medication the patients, and raise patient satisfaction as com-
patient no longer needs. The blood pressure mon- pared with noisy hospital environments [45].
itor goes off after a nurse adjusts a catheter in the Reduced noise was the most common item
patient’s artery. reported by hospital executives as a way to
Excessive numbers of alarms—particularly improve Patient-Reported Outcomes Measures
alarms for events that aren’t clinically significant (PROM) [46]. Almost 90 % of these executives
or that could be prevented from occurring in the believed that the primary benefit for patients was
first place—can lead to fatigue or worse ignoring better sleep to help patients recover faster (75 %)
the alarms as a form of tuning out, an unintended and improve stress/anxiety (67 %).
consequence of alarms, and ultimately patient
harm [39]. Alarm fatigue, a condition which can
occur in any hospital, is usually not caused by a Source–Path–Receiver Model
single device but rather to the cacophony of noises
and aggregate conditions under which alarms A simple approach to analyzing noise in surgical
occur [40]. Alarm fatigue results in confusion and areas is by considering three basic elements: the
stress resulting from loud and conflicting signals sound source, the conveying medium, and the
which can lead to dangerous, life-threatening receiver (see Fig. 17.1) [47]. The most appropri-
decisions, and behaviors [41]. Under these condi- ate solutions then require alteration or modifica-
tions, caregivers can easily become overwhelmed tion in any or all of these three components. For
and are unable to respond to any alarm or to dis- instance: (a) to modify the output from source of
tinguish among simultaneously sounding alarms. the noise, (b) to alter or control the sound path to
They can become distracted, with alarms divert- reduce transmission to the recipient, and (c) to
ing their attention from other important patient provide the receiver with personal protective
care activities. Moreover, caregivers can become devices. This cross-disciplinary approach can
desensitized, possibly missing an important alarm provide detailed insights into addressing hospital
because too many previous alarms have “cried noise and alarm fatigue.
wolf” (proved to be insignificant) [42]. For example: (a) Sources, e.g., planning and
In contrast to alarm fatigue, patients can also specification of paging systems, clinical and
be at risk if an alarm does not activate when it monitoring alarm systems; HVAC/ airflow equip-
should, if the alarm signal is not successfully ment and other building mechanical engineering
communicated to staff, or if the alarm is ambigu- (MEP) systems; strategic placement of nursing
ous as to the source or severity of physiologic stations and other dedicated areas where unam-
derangement, that is, does not provide sufficient plified speech occurs; selection of audible moni-
information about the alarm condition. toring alarm systems optimized for sound
Additionally, when the caregiver who recogniz- pressure levels; informational content, audibility,
ing a signal as a valid alarm is unable to respond and their location. (b) Paths, e.g., design and con-
or is unfamiliar with the proper response proto- figuration of the physical plant with attention to
col, patients do not benefit from the value of sound transmission, and specification of sound
these technologies [43]. In short, any circum- absorptive surface materials to limit sound mix-
Fig. 17.1 Noise control procedures are applied to source, path, and receiver (Modified from [46])
ing and reverberation. (c) Receivers, e.g., modi- he Role of Alarm Standards
T
fying traffic flow and other behaviors through and Codes
architectural and equipment layouts to ensure
that caregivers and patients can hear and respond There are three main standards relating to alarm
without being distracted, confused, and fatigued signals as recognized by the U.S. Food and Drug
by high levels of ambient noise. Administration: (a) IEC/ISO 60601-1-8:2006
Numerous case studies demonstrate methods Ed.2: medical electrical equipment, part 1–8: gen-
for reducing noise levels and improving signal- eral requirements for safety—collateral standard:
to-
noise ratios through changes to programs, general requirement, tests, and guidance for alarm
procedures, maintenance, and modifications to systems in medical electrical equipment and medi-
the physical environment [48]. Noise reduction cal electrical systems; (b) ANSI HE75: 2009,
measures found to be effective follow these human factors engineering—design of medical
same three parallel components: eliminating or devices; and (c) IEC62366, medical devices—
reducing noise sources, for example, by replac- application of usability engineering [50].
ing overhead paging with wireless communica- The current international standards for alarms,
tion devices carried by staff; insulating loud IEC 60601-1-8, stipulate that medical device
noise sources such as ice machines and pneu- audible alarms should be priority encoded and
matic tubes, and conducting group conversa- validated for efficacy. Yet, evidence shows that
tions in an enclosed space; and modifying the melodic alarms described in the standard do
transmission by installing sound-absorbent sur- not function in situ as intended [51]. Clinical
faces such as high performance ceiling tiles and urgency information when patients are in distress
providing receiver protection such as in single- needs to be encoded using a human factors para-
bed patient rooms [49]. digm for alarm design via modulation of the
physical characteristics of sounds. New standards or didn’t respond appropriately [60]. Most cur-
should be developed to bring consistency across rent medical device systems, for example, do not
devices and manufacturers [52]. relay information in real time. In typical use, data
There is little evidence, however, that the acquired from medical devices goes to a queue
urgency-encoding standards proposed in IEC that waits for a clinician to validate before it is
60608-1-8 actually works in a complicated and pushed into the chart. Innovative data mining and
noisy operating room environment where task ongoing trend analyses could better indicate
loads and ambient noise can be significant [53]. patient deterioration and facilitate relevant clini-
An important point stressed in the IEC standard is cal action before full ‘rescue’ efforts are initiated.
that any new audible alarm be validated before This level of interoperable connectivity requires
implementation. However, the suggested melo- cooperation between vendors. Medical device
dies and the suggested method for urgency encod- vendors want to control the mechanisms and
ing espoused by the standard were never, alerts associated with their devices to create end-
themselves, validated in clinical real-world—let to-
end proprietary solutions. Without pressure
alone in simulated—clinical settings [54]. from clinicians and purchasers, common busi-
Furthermore, the standard does not offer a valida- ness concerns will keep device and healthcare IT
tion method [55]. manufacturers from collaborating on solutions
Standards and guidelines relating to alarms that could help mitigate persistent alarm prob-
and ambient noise levels in healthcare facilities lems. Healthcare providers can be better technol-
can be found in the Guidelines for the Design and ogy consumers by advocating for what they need
Construction of Health Care Facilities (2014) from vendors. Providers should identify the gaps
from the Facility Guidelines Institute (FGI) [56] in current alarm notification systems and draft
and the Sound & Vibration Design Guidelines 2.0 requirements for future purchases. Vendors,
[57]. These two documents are referenced in the expectedly design equipment and interfaces with
Joint Commission report Planning, Design, and a “device-centric” perspective at the Point of
Construction of Health Care Facilities, 2nd Care (POC). Meaningful improvements in patient
Edition [58], and in the U.S. Green Building safety require that alarms be clinically significant
Council’s new LEED Rating System for Health and are integrated to the sociotechnical environ-
Care [59]. In addition, a new IEC standard is in ment using a “patient-centric” approach [61].
draft: IEC 80001-2-x: application of risk man-
agement for IT networks incorporating medical
devices offering guidance on the integration of dvocating for Change to Improve
A
alarms. Alarm Management (Fig. 17.2)
Addressing alarm fatigue will require changes in

he Role of Medical Device Designers
T how individuals and teams address noise mea-
and Manufacturers sures. Any approach must be grounded in team
theory, account for individual and team-level per-
Medical devices in the operating room often suf- formance, processes and outcomes, adhere to
fer from fundamental flaws in their interface standards for reliability and validity, and address
design and thus impair alarm usability. barriers to measurement. A 2011 summit
Manufacturers are required by the FDA to inves- addressed alarm fatigue focusing on the prag-
tigate deaths when hospitals report them as moni- matic aspects of training staff and offered a num-
tor related, but almost always attribute the patient ber of recommendations for research in the real
deaths to human error, concluding that monitors clinical setting where alarms must function to
worked correctly but staff misprogrammed them help teams deliver safe care [62].
Organizational Environment: uiding Principles in Alarm

G
The Role of Clinical Microsystems Management
in Addressing Alarms
In an April 2013 Sentinel Event Alert, the Joint
Noise and alarm management exist within the Commission cited 98 alarm-related events over a
context of technology, providers, and patients, three-and-a-half-year period, with 80 of those
i.e., a system. A system is a set of interacting, events resulting in deaths [65]. In June 2013, the
interrelated, or independent elements that work Joint Commission announced the creation of a
together in a particular environment to perform new National Patient Safety Goal (NPSG) focused
the functions that are required to achieve a spe- on clinical alarm safety. This NPSG calls on each
cific aim. A clinical microsystem is a group of hospital to understand its own situation and to
clinicians and staff working together with a develop a systematic, coordinated approach to
shared clinical purpose to provide care for a pop- alarm deaths and permanent loss of function.
ulation of patients [63]. The clinical purpose and Addressing clinical alarm hazards requires a com-
setting define the essential components of the prehensive alarm management program involving
microsystem, which include clinicians, patients, stakeholders throughout the organization.
and support staff; information and alarm technol- Best practice goals for hospital alarm manage-
ogy; and specific care processes and behaviors ment programs should include (1) minimizing
that are required to provide care. The best micro- the number of clinically insignificant or avoid-
systems evolve over time, as they respond to the able alarms so that the conditions that truly
needs of their patients and providers, as well as to require attention can better be recognized, and
external pressures such as regulatory require- (2) optimizing alarm notification and response
ments. They often coexist with other microsys- protocols so that the patient receives the appro-
tems within a larger (macro) organization, such priate care at the time it is needed. Institutions
as a hospital [64]. can improve management of cardiac monitor
Fig. 17.2 Alarm management

program. (Modified from ECRI [70]).
Table 17.3 Institutional alarm management strategy Table 17.4 Alarm management guiding principles
• Establish a broad-based multidisciplinary alarm • The organizational complexity of healthcare must
working group be recognized
• Understand the recurrent manufacturer alarm • Patient-centered health services means that the
defaults patient’s perspective and acoustic well-being must
• Extract and evaluate their alarm data be central to all healthcare policy, planning, and
• Observe staff response to alarms, looking for the procurement decision making
barriers to timely response • Quality healthcare includes all aspects of service
• Identify with clinician stakeholders clinically delivery: clinical and nonclinical
insignificant alarms • Patient safety must be the foundation of acoustic
• Remove audible notification for clinically decisions regarding alarm management
insignificant alarms • Systems of care, and facilities, as well as
• Choose an alarm setting that requires staff response individuals, affect the quality of healthcare
for all clinically significant alarms • Learning from error, rather than seeking someone
• Standardize alarm defaults across patient care units to blame, must be the priority of health policy
wherever possible makers in order to improve safety and quality
• Empower nursing staff to eliminate false alarms, • Openness and transparency are crucial to the
appropriately adjusting alarm in real time after development of trust between health facility
validation with second registered nurse procurement and healthcare professionals, patients
and consumers, and the wider public
Table 17.5 Focus on alarm parameters

alarms without requiring additional resources or
technology (Table 17.3). • Implement safety checks on alarm settings
The environment has a significant impact on • Revise default alarm parameters in each unit to
actionable levels—recognize that settings may
the ability of clinicians to build trusting, thera- vary from one unit to another
peutic relationships. The physical structure and • Implement revisions/changes incrementally
design of healthcare buildings must support the • Prioritize and differentiate between actionable
model of care with appropriate physical, social, alarm signals in each unit, e.g., visual vs. auditory
and symbolic environments. The design process (recognize that settings may not be the same from
for healthcare environments needs to be radically one unit to another)
• Define alarm condition types, e.g., false, true,
changed to address the needs of patients, provid-
nuisance, unactionable, etc., and assure that
ers, and the community at large. We are moving definitions are understood by unit staff
from a decade of highly structured top-down pro- • Gather quantitative baseline data to evaluate alarm
grams to local ownership and more transparent conditions
community partnerships. Engagement strategies • Examine logs from the network that track alarm
need to include: (1) get clinicians ‘moving and messages from devices in order to capture the
quantitative data
experimenting’ with their own systems; (2) pro-
• Observe alarm condition patterns and distinguish
vide permission, space, and time for clinicians to between alarm conditions
find purpose and set their own direction in part- • Compare pre- and postdata to measure changes
nership with their patients and consumers; (3)
direct attention through hyper transparent mea- nature which characterizes the cultural and intel-
suring, collating, and sharing of data about ‘what lectual development of so many of our profes-
is happening’ at the service delivery level; and sional and commercial institutions. Designing
(4) facilitate respectful interaction between clini- better methods to learn from adverse events that
cians and managers (Table 17.4). are caused or are part of a larger adverse event is
Creating an environment where a culture of key to changing clinicians’ attitudes towards
patient safety can flourish is a daunting challenge alarm-related events [67]. Designing new train-
[66]. Innovation will not happen if participants in ing programs and assessing learners in a more
the process are not invited or are unable to think holistic and meaningful way will require innova-
outside the constraints of convention especially if tive training and engagement approaches (see
they are unwilling to challenge the risk-averse Table 17.5).
Table 17.6 Training recommendations If, however, alarm function is considered to be

• Undertake risk analysis of patient populations that of maintaining situational awareness, design-
within acute care facilities to develop standards for ers need to engineer monitor devices able to do
monitor assignment and continuation
some or all of the following: distinguish artifact
• Examine indicators of patient deterioration such as
respiration rate, pulse rate/heart rate, systolic blood
from real state changes, determine the importance
pressure, pulse oximetry, to determine which of state changes within context, convey alarm
indicators should be monitored source, and allow prioritization when operating
• Design simulation scenarios from reported harm or attention is directed elsewhere (e.g., during line
near misses with trigger events that link alarm placement) or when multiple alarms sound.
fatigue and teamwork skills to training objectives
and specific competencies Development of more advanced device algo-
• Design a parallel set of scenarios that can be used rithms is needed to balance the sensitivity and
to evaluate the effectiveness of training these specificity in triggering alarm signals, to block
specific competencies artifacts, and to produce clinically relevant alarms.
• Develop and apply measures of success in alarm Real-time trend analyses must be conveyed so
management
care can be delivered before full patient rescue is
• Embed training in alarm management into
multidisciplinary teams so members train in the
required. Hospitals need a system-wide alarm
context in which they will work policy and protocols that define the alarm man-
agement strategy for alarmed medical equipment,
and delineate how caregivers/nurses respond to
Asking the right questions while focusing on alarm conditions and signals. These conditions
the correct parameters that mean the most to pro- produce an “acoustic feedback loop” in which
viders can go a long way to gain trust of provid- noise inevitably and rapidly escalates to intolera-
ers (Table 17.6) [62]. ble levels and interfere with behavior. It is impera-
tive to use a human factors-based approach based
around the hospital’s culture and engage archi-
Conclusions tects, designers, acoustical engineers, facility
engineering, staff, and clinicians to address alarm
Hospital noise routinely exceeds international, fatigue and its implications on the physical built
WHO noise acceptable standards and is more environment [69]. Involving patients in the rede-
than just an annoyance. This failure to provide sign of hospital acoustic environments may also
patients with quiet rooms due to alarms and improve patient experiences and satisfaction with
other ambient noise affects clinical outcomes their hospital care. There is a compelling role for
through several mechanisms, including sleep industry cooperation that will facilitate device
deprivation, cardiovascular derangements linkages to limit alarm redundancy, standardize,
(increased heart rate and blood pressure), poor and scale alarm signals to convey urgency, develop
wound healing, higher incidence of readmis- alternative modalities and sensory channels, and
sions, patient falls, pain, stress, and dissatisfac- enhance options for central oversight.
tion [65]. Moreover, poor acoustic clinical
environments are associated with excessive cog-
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Implementation Science:
Translating Research into Practice 18
for Sustained Impact
Gregory A. Aarons, Marisa Sklar, and Nick Sevdalis
“…translational research refers to translating research into practice; ie, ensuring that
new treatments and research knowledge actually reach the patients or populations for
whom they are intended and are implemented correctly.”
—Woolf, SH. The meaning of translational research and why it matters.
JAMA. 2008; 299(2), 211–213.
While there are new and emerging health tech-

What is Implementation Science? nologies and efficacious health interventions,
there is a gap in the utilization of such interven-
In the past 20 years there has been a growing
tions in public health and healthcare settings
imperative to bridge the gap between scientific
[3–11]. Despite significant taxpayer dollars hav-
discovery and the development of evidence-based
ing been allocated for the basic science discovery
health innovations and practices (EBPs), and the
and the development of EBPs, the public health
effective and efficient delivery of evidence-based
impact of these investments has been limited.
care to those who would most benefit [1, 2].
For basic scientific discovery and develop-
ment of EBPs to have greater public impact,
people must interact in some way with the results
of these research and evaluation efforts. With
practitioners’ busy schedules and the over-
whelming amount of output produced through
G.A. Aarons, PhD (*) research, an unawareness of, and/or a lack of
Department of Psychiatry, UC San Diego School of easy access to, the latest research findings can
Medicine, 9500 Gilman Drive (0812), La Jolla, CA
92093-0812, USA act as a barrier to the spread of knowledge.
e-mail: [email protected] Consequently, there has been a movement in the
M. Sklar, PhD field of scientific publishing toward open access
Department of Psychiatry and Human Behavior, to research results [12]. There is a huge body of
Brown University, Providence, RI 02912, USA knowledge available for discovery, most of
Memorial Hospital of Rhode Island, which is published in scientific journals. The
Pawtucket, RI 02860, USA open access movement suggests that communi-
e-mail: [email protected] cation of research findings could be improved
N. Sevdalis, BSc, MSc, PhD through increasing accessibility and readability
Health Service & Population Research, Institute of of scientific journals. The open access move-
Psychiatry, Psychology & Neuroscience, King’s
College London, David Goldberg Centre (H2.05) De ment seeks to make research articles and scien-
Crespigny Park, Denmark Hill, London SE5 8AF, UK tific journals readily available to anyone, any
e-mail: [email protected] time, free of charge, over the internet.

278 G.A. Aarons et al.
Despite open access to research findings, the implementation efforts are believed to facilitate
gap between what we know to be true and effec- the translation of research into policy and practice.
tive from research and what is actually dictated in The underlying theory is that effective policies
policy and/or applied in practice remains. In 1995, and practices are not being applied due to a lack of
the General Accounting Office proposed that the access to evaluations and evaluation findings and
problem was not in access to research and evalua- a lack of communication and cooperation between
tion findings, but that “available information is not researchers and their intended audiences. If evalu-
organized and communicated effectively” [13]. ation and research results are in a cumbersome
Many theorists suggest evaluation research and report that is too lengthy for relevant stakeholders
evaluation research reports be designed in a man- or uses scientific jargon, it is unlikely the report will
ner which leads to clear communication of find- be read, and unlikely the evaluation and research
ings, easily understood by relevant stakeholders. will be influential [23]. Correspondingly, innova-
The open access movement implies an influ- tion development, implementation, and evalua-
ence or impact of research and evaluation tion are lengthy, costly, endeavors. If practitioners
efforts through passive diffusion. Diffusion is a and policymakers fail to recognize evidence for
relatively passive process wherein new knowl- effectiveness from these efforts, they risk creating
edge is communicated through certain chan- a cycle of reinventing the wheel, or reinventing
nels over time among the members of a social something less effective [24]. Furthermore, the
system [14]. A growing knowledge of evalu- research-to-policy and research-to-practice gaps
ation research implementation has suggested will remain.
that passive diffusion of innovative research Implementation science focuses on decreasing
is largely ineffective and unlikely to result in these gaps through the development of and test-
influence [15–19]. Practitioners have continued ing of frameworks and strategies for improving
to express an uncertainty about where and how the dissemination and implementation of EBPs
they should access the best information [20]. [2, 6]. Implementation research has been defined
Some even suggest that the volume of avail- as “…the scientific study of methods to promote
able information can lead to information over- the systematic uptake of research findings and
load [21]. Even when practitioners have access other evidence-based practices into routine prac-
to various sources of information, there is still tice, and, hence, to improve the quality and effec-
confusion regarding which sources of infor- tiveness of health services. It includes the study
mation are credible, and which ones are most of influences on healthcare professional and
relevant to their work [20]. Some practitio- organisational behaviour” [25, p. 1]. The United
ners even express the lack of time to seek out States National Institutes of Health defines
information that is not targeted directly to them implementation research as “…the scientific
[20]. With regard to the research-to-policy study of methods to promote the integration of
gaps, Weiss [22] has noted that policymakers research findings and evidence-based interven-
are very busy people, with “little time available tions into healthcare practice and policy. It seeks
for reading,” with no “time to study and ana- to understand the behavior of healthcare profes-
lyze.” These findings suggest that it is simply sionals and support staff, healthcare organiza-
not enough for researchers to rely on diffusion tions, healthcare consumers and family members,
of evaluation findings. Rather, the more active and policymakers in context as key variables in
approach of dissemination and implementation the adoption, implementation and sustainability
is necessary. of evidence-based interventions and guide-
Recognition of the failure to translate research lines…” [26]. Some of this research has focused
findings to widespread use via passive diffusion on the development and testing of implementa-
has led to research designed to help the dissemination frameworks and/or models that identify
tion and implementation of knowledge to a wide- structures and processes that can impede or
spread audience. These active dissemination and enhance EBP implementation efforts.
18 Implementation Science: Translating Research into Practice for Sustained Impact 279
Implementation Frameworks tional, provider, and patient levels. Figure 18.2

shows the multiple phases and levels of the EPIS
A recent review catalogued over 60 implementa- framework. Note that some factors (e.g., fidelity,
tion frameworks [27]. Many implementation provider attitudes, interorganizational networks)
frameworks utilize a multilevel approach to enu- are relevant to multiple EPIS phases.
merate different components, structures, and pro- In order to illuminate this complexity, we
cesses of the implementation endeavor [28–30]. provide the following hypothetical example: In
Implementation frameworks may note that char- the exploration phase, a service system, organi-
acteristics of the intervention (e.g., direct costs, zation, (e.g., hospital, clinic, community-based
time demands, specificity, expertise required by provider, etc.) or an individual considers what
the user) and the quality of evidence supporting factors might be important in regard to imple-
the EBP are critical [31]. Others have noted that menting a practice. For a new empirically sup-
the fit of an innovation with the context for imple- ported and approved medication, these might
mentation (e.g., hospital, community health include regulatory and reimbursement con-
clinic, school, public sector health system) is a straints (e.g., FDA approval, health plan formu-
critical consideration [30, 32–34]. laries), training and support for physicians and
pharmacists in appropriate prescribing, and
potential drug interactions. In the preparation
he Exploration, Preparation,
T phase, changes in formularies would be made
Implementation Sustainment (EPIS) and electronic health records would need to be
amended to allow for documenting indications
Implementation framework. A number of frame- and prescribing. Plans would need to be made
works approach implementation as a complex, for physician/pharmacist training including
multiphasic process that involves multiple stake- scheduling, procuring space, and follow-up
holders in service systems, organizations, and coaching and support, if needed. In the imple-
practices [28, 35, 36]. One such framework is the mentation phase, training begins along with
Exploration, Preparation, Implementation, and assuring that the medication is now available in
Sustainment (EPIS) implementation framework. formularies and available for patients to obtain
EPIS considers the implementation process in from pharmacies. In the sustainment phase,
four phases: Exploration (consideration of new ongoing monitoring would involve oversight of
approaches to providing services), Preparation quality of care, appropriateness of prescribing
(planning for providing a new service), practices, patient adherence, and patient out-
Implementation (provision of this new service), comes (including new studies or clinical experi-
and Sustainment (maintaining this new service ence) would be utilized to understand and
over time) [37]. The EPIS model also empha- increase the likelihood of positive outcomes.
sizes the importance of contextual factors in the While this example is oversimplified, it illus-
outer (policy, system) and inner (organizational, trates that there are a number of issues to be con-
work team) contexts [37]. Thus, EPIS attends sidered in order to facilitate effective
to issues both inside the unit providing services implementation of an EBP in each EPIS phase.
(i.e., service organization, surgical team) as well
as those in the larger environment in which the
service unit operates (e.g., policy and funding, Implementation Outcomes
interorganizational networks, relationships with
intervention developers and technical assistance Another important consideration is that of
providers, certification, and regulatory environ- “implementation outcomes” that differ from
ment). Figure 18.1 shows the EPIS framework clinical outcomes. Implementation outcomes
considering outer and inner context, intercon- are unique and distinct from either service sys-
nectedness, and EBP fit at the system, organiza- tem outcomes or clinical treatment outcomes
Fig. 18.1 EPIS framework illustrating outer and inner context, linkages, EBP fit, and intervention developer
Fig. 18.2 Exploration, Preparation, Implementation, Sustainment (EPIS) Framework illustrating the four implementa-
tion phases and outer context and inner context implementation considerations
and have been defined as the “…effects of onsideration of Organizational

C
deliberate and purposive actions to imple- Context in Implementation
ment new treatments, practices, and services”
[38]. Implementation outcomes have multiple There are a number of common organizational
functions including serving as indicators of processes likely to be associated with successful
implementation success, representing imple- implementation [28, 30]. There may be a ten-
mentation processes (e.g., mediators/moderators dency to focus on processes directly involved in
of change), and can be intermediate outcomes healthcare, including the care recipients (e.g.,
in treatment effectiveness and quality-of-care patients, clients) and care providers (e.g., doc-
research [38]. Implementation outcomes may tors, nurses, clinicians). However, it is important
include factors such as acceptability, feasibil- to consider that healthcare and allied health ser-
ity, reach, fidelity, and costs of implementation vices (e.g., mental health, social care) are deliv-
including those above and beyond the cost of the ered to the public within the larger contexts of
clinical intervention [39]. There is often a lack work groups, healthcare organizations and wider
of consideration of the costs of implementation local or regional health economies, and public
that can, in and of itself, limit implementation health systems of various sizes and scopes [42].
effectiveness [38, 40]. Figure 18.3 illustrates Organizational factors involving stakeholders at
this distinction noting implementation outcomes multiple levels impact successful organizational
including constructs such as feasibility, organi- change, such as implementation [29, 43, 44]. In
zation or provider adoption, penetration (i.e., fact, it is becoming increasingly clear that orga-
reach) to providers or patients, and costs. These nizational and cultural factors are likely to have
are distinct from Institute of Medicine Standards more impact on successful implementation of
of Care (e.g., safety, patient-centeredness, etc.) EBP compared to individual factors (e.g., clini-
or patient outcomes (e.g., functioning, symp- cian age or degree) [45, 46]. Characteristics of
tom reduction, etc.). Because it is assumed that implementation settings (e.g., systems, organi-
a given EBP will be less effective if it is not zations) are critical for effective adoption and
well implemented, implementation outcomes use of EBPs and it is often the leaders of systems
are important precursors for attaining changes in of organizations who are responsible for devel-
clinical practice. It is also critically important to oping a context that supports a strategic initia-
distinguish implementation outcomes from other tive such as EBP implementation [47].
outcomes in hybrid design studies that examine It follows that evaluating the context within
both implementation along with clinical effec- which an EBP will be introduced and embedded
tiveness or efficacy within the same study [41]. is becoming increasingly important. Numerous
Fig. 18.3 Implementation
outcomes as distinct from
service outcomes and client
outcomes
current efforts focus on developing measures of and organizational context were important in the
implementation context to better inform, assess, implementation process [44]. Thus, consistent
and facilitate successful EBP implementation. with generalizability in organizational research,
For example, a new measure of implementation such organizational and leadership approaches
leadership identified four distinct leader attributes to implementation are likely to generalize across
likely to be important in the implementation pro- health and allied healthcare settings.
cess [48]. These include the leader being knowl- Given evidence from observational studies of
edgeable about the new practice, supportive of leadership, novel research is being conducted in
team members in implementing the practice, pro- the development and testing of implementation
active problem-solving implementation issues as strategies to improve leader knowledge, skills,
they arise, and persevering through the ups and and effectiveness for implementation and sus-
downs of the implementation process [49]. Other tainment of new innovations. One such approach,
measures capture organizational climate that the Leadership and Organizational Change for
would facilitate EBP implementation and sustain- Implementation (LOCI) intervention, combines
ment. Dimensions include providing educational the training of team leaders in transformational
supports and training for EBP, recognition and leadership and implementation leadership, while
rewards for excellence in EBP delivery, and also working with organizations to provide
selecting team members who are adaptable and appropriate organizational supports to develop a
have experience with EBPs [50]. Another more positive organizational and team climate for
general measure of implementation climate implementation [56, 57].
assesses the degree to which use of the new prac- One of the most well-known and most heavily
tice is expected, supported, and rewarded by the researched approaches to leadership is the full-
organization [51]. Related to these efforts, there range leadership model most closely aligned with
is also interest in, and measures for, assessing transformational leadership. This model captures
organizational readiness for change [52]. leadership behaviors across the dimensions of
Implementation leadership. Connecting individual consideration (understanding the needs
these issues, Aarons and colleagues identify of individual team members), intellectual stimula-
how leaders may facilitate the development of tion (engaging team members in problem solving
organizational climates that support EBP imple- and innovation), inspirational motivation (creating
mentation while enumerating important com- a compelling vision for others to follow), and ide-
ponents of the implementation process [28, 30, alized influence (serving as a role model) [58].
32]. An example that highlights literature on Research has demonstrated that transformational
organizational climate and implementation cli- leadership is associated with increased job satis-
mate, and outlines approaches to leadership that faction [59, 60]; organizational commitment [61];
can support the development of such climates, and performance for leaders [62, 63], teams [64,
involves the implementation of minimally inva- 65], and employees [66]. Of specific relevance to
sive approaches in cardiac surgery teams [53]. this chapter, transformational leadership has been
Amy Edmondson and colleagues conducted a shown to be particularly important for ameliorat-
study of organizational, leadership, and team ing the negative impact of organizational stress on
process among such teams in four different work group climate during large-scale behavioral
hospitals. They found that leaders who moti- health reform [67] and to support positive attitudes
vated their teams and minimized power differ- to EBP in statewide system change efforts [68].
ences created a positive psychological safety Transformational leadership is also associated
climate that enabled effective implementation with successful implementation efforts [69, 70].
and sustainment of minimally invasive cardiac New work on implementation leadership has iden-
surgical procedures [54, 55]. This work is con- tified four additional leader attributes including
sistent with previous work in business settings knowledgeable leadership (having expertise about
demonstrating that both management support the new innovation to be implemented), supportive
leadership (supporting staff in their implementa- levels of leadership and staff to facilitate congru-
tion efforts), proactive leadership (i.e., anticipating ence of mission and process. If not addressed,
and solving problems during the implementation work group leaders (i.e., those who supervise
process), and perseverant leadership (i.e., perse- direct service staff) may not have needed buy-in,
vering through the ups and downs of the imple- organizational support, or an understanding of
mentation process) [49]. For implementation to be the rationale behind the decision to implement
successful, team leaders must be proactive and EBP required to communicate the rationale to
perseverant in communicating their knowledge of their teams [44]. Furthermore, although strategic
and support for EBP while managing resistance to decisions about implementing EBPs are com-
change and communicating the importance of the monly made by upper level leaders, the effective-
change being implemented [49, 71–74]. ness of implementation efforts is driven by
Although much of the literature on leadership first-level leaders and the providers who deliver
has focused on the organizational and work group the actual services [82–84]. Consequently, the
levels, healthcare organizations can be strongly implementation process can be better facilitated
influenced by the decisions and policies made or if led by “first-level” or team leaders [85].
instantiated by leaders at the system level. Although a majority of leadership research
Decisions and policies at the system level can has focused on the individual leaders, studies
impact funding, disbursement of resources at have demonstrated the importance of alignment
state and local levels, and policy making to sup- across multiple levels of leadership [72, 86, 87].
port EBP implementation [75]. Leaders in the Chreim and colleagues [82] examined system-
Veteran’s Health Administration (VHA) devel- level factors that influenced implementation pro-
oped The Uniform Mental Health Services cesses during the transformation of healthcare
Handbook [76] that includes a number of man- service delivery to a new model within one
dates that help create the capacity for medical Canadian province. They found that implementa-
centers and outpatient clinics to deliver EBPs. tion was supported through agreement, participa-
The handbook specifies that each VA medical tion, commitment, and congruence of support at
center have an EBP implementation coordinator all levels of leadership. At the work group level,
responsible for educating providers and upper the degree to which providers agree about the
level management about EBP, encouraging pro- strategy or change being implemented predicts
viders to attend EBP trainings, working with implementation success [88]. Similarly, the
leaders at the organization and work group levels, aggregate of multiple levels of leadership pre-
and with providers to increase delivery of EBPs dicts organizational outcomes as a function of
in clinical care. Consistent with the EPIS multi- strategic implementation efforts [72]. This inter-
level framework, this approach recognizes that play between different leadership levels has been
leaders in the outer context (system) can develop identified as a key factor in the implementation of
policies that impact the inner context (e.g., hospi- a multicenter clinical quality improvement inter-
tals, clinics, workgroups, providers). vention across multiple hospital medical wards in
Leaders at the organization level (e.g., CEOs, the UK [89]. The intervention consisted of team-
presidents, administrators) often are responsible based clinical safety briefings, designed to embed
for decisions regarding implementation of new proactive risk surveillance within routine, daily
practices and organizational strategies [72, 77]. ward work. Through a 20-month implementation
This level of leadership is often involved in secur- and evaluation period, the research team reported
ing funding, which may be related to the decision a shift in focus from the frontline healthcare pro-
to implement new practices as funders are viders to the middle- and higher level organiza-
increasingly requiring the use of EBPs [8, 78– tional management structures, as these emerged
81]. However, congruence or alignment across as critical determinants of the implementation
levels is an important consideration. The chal- effectiveness, and, in turn, its clinical effective-
lenge for executive leaders is to involve other ness on care processes and patient outcomes. We
propose that such congruence and alignment is evaluated the clinical efficacy of a 19-item check-
important because it facilitates a positive imple- list developed to address the Second Global
mentation climate among stakeholders [47]. Patient Safety Challenge: Safe Surgery Saves
Lives, as part of a World Health Organization ini-
tiative [97]. The WHO Checklist consists of three
I mplementation of Surgical parts, the first applied before the patient is anaes-
Checklists thetized (‘Sign-In’), the second immediately
prior to surgical incision (‘Time-Out’), and the
Many, if not all, elements of implementation final one immediately prior to procedure comple-
research and also practice that we outlined earlier tion (‘Sign-Out’). The subsequent evaluation of
are illustrated in the recent trajectory within this checklist across eight countries worldwide,
hospital-based care of checklists in surgical care. including both developed and developing world
The concept of avoidance or reduction in postop- economies, provided startling findings: across
erative complications is likely as old as surgery study hospitals, the WHO Checklist reduced
itself—see for example efforts by Codman [90] mortality by almost 50 %, whereas overall com-
in early twentieth century to systematically plication rate decreased by over a third [98]. The
record and measure surgical outcomes. However, WHO Checklist became an instant success
the political and policy drive to improve the story—within weeks of publication of the study
safety and quality of surgical care via a range of results in the New England Journal of Medicine,
evidence-based interventions flourished in the the National Patient Safety Agency (NPSA) in
past two decades—as it did for all of medicine. England mandated use of a slightly modified ver-
Sparked by the influential report by the Institute sion of this checklist across all surgical proce-
of Medicine ‘To Err is Human’ [91], initial dures [99]. Subsequent patient safety campaigns
efforts to improve safety concentrated on estab- in England (e.g., Patient Safety First campaign
lishing the epidemiology of errors, lapses, and [100]) and internationally included this checklist
patient safety incidents, as well as understanding almost by default, as a flagship intervention for
their nature. We now know that, on average, 1 in improvement of surgical care. Widespread dis-
10 patients admitted to hospital will suffer at semination of surgical checklists was indeed
least one adverse event as a result of their care intended: a checklist implementation manual was
[92]. Although the majority of adverse events are produced by the developer team [97], followed
minor, some lead to serious injury or death [93]. by video-based examples produced by the NPSA
Approximately 60 % of them on average occur in England showing how to do (and not to do) the
within surgical care [94]. The importance of Checklists in the OR [101].
teamwork in healthcare is firmly established,
with recognition that many high-profile failures
were due in large part to substandard teamwork, Fading Evidence
including in the highly complex operating room for Implementation of Surgical
environment [95, 96]. In recent years, the focus Checklists
has shifted from understanding, to intervening
and preventing—and this is when aviation-styled A flurry of studies followed, included random-
checklists were first implemented in surgery. ized trials [102]—using this and other checklists
in surgical pathways. But the findings were not as
unequivocal—reductions in mortality in particu-
arly Support for Implementation
E lar were not found [103]. Explanatory hypotheses
of Surgical Checklists that proposed that checklists achieve their clini-
cal efficacy via improved team and safety culture
The current widespread prevalence and ongoing remain controversial, with some studies support-
discussion of surgical checklists is due in large ing these hypotheses [104], but others not finding
part to a large-scale international study, which evidence for such links [105]. However, the big-
gest ‘upset’ in the checklists evidence base to team withdrew from the clinical areas; further
date is the largest implementation evaluation— underutilization of the intervention was attributed
across the Ontario province in Canada. This to cultural, organizational, and practical barriers.
remains the largest regional implementation of Leadership was recognized as a key strategy for
the WHO Checklist in a study of routine surgical improved implementation, both at organizational
care of over 215,000 patients in Canada, where level but also at the operational level, through
no reduction in mortality or morbidity indicators checklist ‘champions.’ Although qualitative
was found [106]. Surprise was expressed at these implementation analyses such as this one are
results, which were speculatively attributed to the hard to repeat longitudinally for direct compari-
likely nonuse of the checklist in practice [107]—a son, more recent studies using standardized
likely valid explanation but one that does not observational assessments in the OR while the
address the barriers to change of culture and checklist is being carried out have confirmed the
behaviors [108]. same pattern [111, 112].
The problem may in fact have wider implica-
tions. Naïve portrayal of checklists in surgery
Incomplete Plan presents them as the ‘silver bullet’ that can cost
for Implementation of Surgical effectively improve the way a team communi-
Checklists cates and shares information and thus improve
basic care processes (including timely adminis-
What is the catch here? The answer is, at least tration of antibiotics, appropriate deep vein
partly, certainly within incomplete and ineffec- thrombosis prophylaxis, robust patient identity
tive methods for implementation of checklists. As checks and similar) and ultimately patient out-
in many areas of medicine, efficacy evidence nor- comes. This may indeed happen in some cases—
mally stems from research-funded studies, where but it likely will not happen when safety lapses
interventions under scientific scrutiny are given and quality gaps are underlined by deeper team
every chance of being efficacious: their imple- and organizational problems [113, 114]. The nar-
mentation is careful, well thought-out, carried out rative for both the effectiveness and also the
by motivated staff with time dedicated to deploy implementation of checklists in complex clinical
them. Yet, routine clinical practice typically does environments has thus been oversimplified in a
not replicate the resource-rich, highly motivated, manner that is not conducive to enhancing our
expert research setting of a trial. Further, what the understanding of exactly how such interventions
initial success story of the WHO Checklists may actually work when they do, and why they fail to
have caused is a sense of simplicity and hope that bring about improvement when they do not [115.
implementation of an evidently simple interven- The comparison of surgery with commercial avi-
tion such as a checklist is vastly cost effective, as ation, where some of the fascination with check-
the costs are practically zero. Unfortunately for lists in healthcare can be traced, has often been
patients, this view is rather naïve—as it fails to accordingly simplistic: aviation did not become
take into account the vagaries of implementing safer just because pilots and crews started relying
what is, in many ways, a behavior change inter- more on checklists in the past few decades. Other
vention within a highly complex sociotechnical factors contributed to safety, in a synchronized
environment (the OR), rife with professional manner; these include technological improve-
identities, team dynamics, and often competing ment, improved skills training, error and incident
organizational pressures (for safety and pro- reporting structured, and safety data sharing at
ductivity) [109]. The signs of an overall naïve international level, i.e., safety in aviation pro-
approach were there from the start. An early anal- gressed at a systemic, industry-wide level [115,
ysis of how the WHO checklist had been imple- 116]. Checklists can certainly enhance safety but
mented in England revealed significant variations likely not as a single isolated safety intervention
between teams and ORs [110]. Use of the check- [117]. With simplistic views of checklists rather
list in this study diminished when the research prevalent, perhaps not surprisingly detailed

implementation analyses of checklists remain little consensus on optimal scientific method-

scarce—in the largest and most detailed one to ology for implementation science research
date that we are aware of, of the national imple- [120–122]. In fact, there is debate regarding
mentation of the WHO Checklist across English the “best” strategies for successful implemen-
hospitals, a host of factors were identified [118]. tation of EBPs [36]. Recent implementation
These cover the full range of implementation science research has begun addressing this
strategies mentioned in earlier sections of this debate. For example, Brown and colleagues
chapter and reveal interactions between them and [123] directly compared two strategies for
significant contextual influences. implementing one EBP across two states. This
study was also successful through their use of
the Stages of Implementation Change (SIC)
Summary and Challenges measure that enabled the measurement of
and Future Directions implementation process across multiple
for Implementation Science stages, multiple milestones, and multiple lev-
Research els of participants. By using this measure, the
authors assessed progress in EBP implemen-
Implementation science is playing a crucial role tation or lack thereof. The authors introduce
in reducing the research-to-policy and research- plans for future advances toward addressing
to-practice gaps with the ultimate intention of this debate. Through a recently funded R01,
advancing health outcomes. However, significant Saldana will adapt the SIC to evaluate com-
challenges present when completing implementa- mon/universal implementation activities that
tion science research. Consistent with issues fac- are utilized across EBP implementation strat-
ing implementation science globally, The US egies, and to examine whether these items are
National Institutes of Health Fogarty International equally important in achieving implementa-
Center (FIC) [119] has outlined challenges facing tion success, and whether stages of implemen-
the field of implementation science research: (1) tation are stable across EBPs despite
implementation science is a new, developing differences in activities defining SIC stages
field; (2) effective implementation requires a [124]. As Brown et al. [123] have illustrated,
multidisciplinary, collaborative approach; and (3) continued coordination and communication of
implementation strategies requires rethinking sci- efforts for broader dissemination of results,
entific rigor and the importance of mixed meth- best practices, and lessons learned are sug-
odologies. These three challenges are described gested for future implementation science
later. The FIC challenges are followed by a dis- research.
cussion of future directions and global initiatives 2 . Interdisciplinary—multidisciplinary and col-
for the field of implementation science. laborative approach. The FIC highlight the
importance of inter/multidisciplinary collabo-
1 . New, developing field. The FIC recognizes the ration for effective implementation. A number
potential for implementation research in of approaches have been utilized including
improving program quality and performance community-based participatory research
through the use of scientific methods. [125], community-participatory partnered
However, implementation science as a field is research [126], and collaborative approaches
relatively new and still in development. There such as the Institute for Healthcare improve-
are many efforts to improve implementation ment (IHI) Breakthrough Series [127], though
of EBPs that utilize a variety of frameworks, a there are few established communication
number of constructs hypothesized to affect channels and forums for such communication.
successful implementation, and many mea- As discussed in this chapter, alignment across
sures of these constructs. With so many efforts levels within and between organizations is
to improve implementation of EBPs, there is crucial for establishing an organizational
climate in support of EBP implementation. classifying implementation strategies, (2) map-

There is often a gap between the expectations ping the similarities and differences between
of researchers who generate and report imple- implementation science and quality improvement
mentation science results and practitioners research, (3) creating a platform for implementa-
who implement results. Congruence between tion research via the Global Implementation
leaders at the organization level (e.g., CEOs, Initiative, (4) providing training for dissemina-
presidents, administrators), frontline provid- tion and implementation research. These are dis-
ers in the trenches of delivering services, and cussed in the following paragraphs.
the implementation science researchers will
facilitate successful implementation of EBPs. 1. Implementation strategies. Recent work on
3. Rethinking scientific rigor. The FIC and the US identifying and classifying implementation
Office of Behavioral and Social Sciences strategies has helped both researchers and
Research stresses the importance of using mixed practitioners to consider multiple approaches
methodology (qualitative and quantitative meth- to consider to support EBP implementation
ods) [128], and methods from fields such as eco- [130, 131]. Beyond a review of implementa-
nomics and business, to guide implementation tion strategies, Powell and colleagues have
strategies and evaluate the implementation of developed and make recommendations
health interventions [129]. Scientific rigor has regarding methods for identifying, selecting,
traditionally referred to random assignment in and tailoring implementation strategies for
highly controlled laboratory settings. In real- use in various health and allied health settings
world settings where random assignment is not [132, 133]. This approach combined with the
always possible, and highly controlled labora- use of an appropriate implementation frame-
tory settings do not provide the context targeted work can provide guidance in the implemen-
through implementation science research, alter- tation process through progression through
native approaches are needed while balancing the four implementation phases [37].
and maximizing rigor in scientific research. 2. Implementation and quality improvement.
Mixed methodology provides an avenue for The literature and the fields of implementation
conducting rigorous implementation science science have held that there is a distinction
research that can be done in the context of an between the two [134]. Of course this becomes
RCT or other design. Other quasi-experimental even more complex as there is consideration
approaches one may consider in the conduct of of how best to implement quality improve-
implementation science research include regres- ment initiatives [135]. However, there are a
sion discontinuity designs, interrupted time number of similarities in quality improvement
series designs, multiple imputation techniques, research and implementation science and both
and propensity score analyses. Type I, Type II, should be considered in a comprehensive
and Type II hybrid implementation science approach to improve delivery of health inter-
research designs that combine implementation ventions [136].
and effectiveness questions and outcomes in the 3. Global implementation initiative. Several ini-
same study are increasingly being used while tiatives have commenced with the purpose of
maintaining scientific rigor [41]. accelerating the use and influence of practices
and policy with demonstrated effectiveness.
One such initiative is the Global
uture Directions and Global
F Implementation Initiative (GII). The GII was
Initiatives for the Field founded in 2012 with the purpose of “promot-
of Implementation Science ing 1) access to implementation networks,
experts and educational and workforce devel-
There are several considerations of future direc- opment opportunities, 2) influence on research-
tions and global initiatives for the field of imple- ers, policymakers, and organizational leaders
mentation science, including (1) identifying and to increase focus on effective implementation
strategies in applied settings, and 3) impact on each year where they receive individualized
the integration of effective implementation mentoring and visit active dissemination and
practices in human service settings in order to implementation research study sites to gain
improve outcomes for children, families, indi- real-world perspectives on the complexities
viduals, and communities worldwide [137].” involved when conducting dissemination
Major initiatives of the GII are the Global and implementation research.
Implementation Conference, the Global
Implementation Society, and organizing Similar programs have started to appear in
Global Implementation University efforts. The Europe as well. In the UK, the Center for
GII initiatives provide a worldwide platform Implementation Science within King’s College
for collaborative approaches promoting effec- London launched an Implementation Science
tive implementation practice, science, and Masterclass in 2014. A 2-day, intensive course
policy. Since GII inception, other implementa- on implementation methodologies and metrics,
tion science initiatives and networks have the Masterclass offers state of the art lectures on
emerged with similar objectives, such as the core implementation topics, followed by small
European Implementation Collaborative, and group interactive sessions for participants to
the current development of the Canadian hone the implementation strategies and mea-
Implementation Network. sures of their research or clinical implementation
4. Education and training. As the field of projects. Alongside the Masterclass, the same
implementation science is rapidly advanc- group launched a Master’s program in
ing, training programs for dissemination and Implementation and Improvement Science in
implementation research are an important 2016. This is a 1 or 2 year program including
avenue to build the knowledge base and taught modules which bridge implementation
capacity of the field. Several training pro- and improvement sciences, and a final disserta-
grams have been developed with the purpose tion project on clinical implementation. Both
of advancing implementation science. One training programs aim to enhance the implemen-
such program is the National Institute of tation capability within healthcare systems inter-
Health and Veteran’s Health Administration nationally. They have been set up through initial
collaborative Training in Dissemination and funding from England’s National Institute for
Implementation Research in Health Health Research.
(TIDIRH). The TIDIRH is a five-day pro-
gram to maximize opportunities for trainees
and faculty to interact, and for trainees to Conclusion
gain exposure to curriculum that includes
structured large group discussions and inter- Our goal in this chapter was to introduce the con-
active small group sessions. Another train- cept of implementation science along with some
ing program for investigators new to the discussion of frameworks, strategies, and exam-
field of dissemination and implementation ples of some of the experiences and challenges
research is the Implementation Research facing implementation science and those wishing
Institute (IRI). The IRI was established at to implement new practices. The authors had to
Washington University in St. Louis with be selective in what to present as each topic could
support from a grant from the National comprise a chapter in and of itself. We encourage
Institute of Mental Health and additional the reader to delve more deeply into how an
support from the U.S. Department of implementation science approach may help to
Veterans Affairs, and the National Institute accelerate the introduction and effective use of
on Drug Abuse. The IRI is a two-year train- new medical procedures and technologies so that
ing program in implementation science the time from evidence-based intervention devel-
wherein fellows attend a 1-week training opment to effective use in practice can be
reduced. The ultimate goal is to improve patient 6. Institute of Medicine [IOM]. Crossing the quality
chasm: a new health system for the 21st century.
care and patient outcomes. This goal should
Washington, DC: National Academy Press; 2001.
always be first and foremost in implementation 7. McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J,
theory, research, and practice. DeCristofaro A, et al. The quality of health care
delivered to adults in the United States. N Engl
J Med. 2003;348(26):2635–45.
Acknowledgements Preparation of this chapter was sup-
8. National Advisory Mental Health Council. Bridging
ported by United States National Institutes of Health
science and service: a report by the National
(NIH) grants R01MH072961 and R01DA038466 (PI:
Advisory Mental Health Council’s clinical treatment
Aarons) and F32HS024192 (PI: Sklar). The views
and services research workgroup. Bethesda: National
expressed are those of the authors and not necessarily
Institute of Mental Health; 1999. Contract No.: NIH
those of the NIMH.
Publication No. 99-4353.
Dr. Sevdalis’ research was supported by the National
9. Proctor EK, Landsverk J, Aarons GA, Chambers D,
Institute for Health Research (NIHR) Collaboration for
Glisson C, Mittman B. Implementation research in
Leadership in Applied Health Research and Care South
mental health services: an emerging science with
London at King’s College Hospital NHS Foundation
conceptual, methodological, and training challenges.
Trust. NS is a member of King’s Improvement Science,
Adm Policy Ment Health. 2009;36(1):24–34.
which is part of the NIHR CLAHRC South London and
10. U.S. Department of Health and Human Services
comprises a specialist team of improvement scientists and
[DHHS]. Mental health: a report of the surgeon gen-
senior researchers based at King’s College London. Its
eral. Rockville: U.S. Department of Health and
work is funded by King’s Health Partners (Guy’s and St
Human Services [DHHS]; 1999.
Thomas’ NHS Foundation Trust, King’s College Hospital
11. U.S. Department of Health and Human Services
NHS Foundation Trust, King’s College London and South
[DHHS]. Report of the surgeon general’s conference
London and Maudsley NHS Foundation Trust), Guy’s and
on children’s mental health: a national action agenda.
St Thomas’ Charity, the Maudsley Charity and the Health
Washington, DC: U.S. Department of Health and
Foundation. The views expressed are those of the authors
Human Services; 2000.
and not necessarily those of the NHS, the NIHR or the
12. Hardisty DJ, Haaga DAF. Diffusion of treatment
Department of Health.
research: does open access matter? J Clin Psychol.
Disclosure Statement: The authors are not aware of
2008;64(7):821–39.
any affiliations, memberships, funding, or financial hold-
13. United States General Accounting Office. Improving
ings that might be perceived as affecting the objectivity of
the flow of information to the congress. Washington,
this review. Sevdalis is the Director of London Safety &
DC: U.S. Government Printing Office; 1995. Contract
Training Solutions Ltd, which provides consultancy and
No.: GAO/PEMD-95-1.
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Part III
Perioperative Quality and Patient Safety
The Leadership Role: Designing
Perioperative Surgical Services 19
for Safety and Efficiency
Victoria M. Steelman and Martha D. Stratton
“Every system is perfectly designed to get the results it gets.”

—Paul Batalden, MD
Commission. Other frequently reported events

Introduction include delay in treatment, operative/postoper-
ative complication, and wrong patient/site/pro-
Despite continued national and international cedure [4, 5].
efforts focusing on improving the quality and Because of the invasiveness of the proce-
safety of healthcare, adverse events and near dures, high-tech environment, fast pace, and
misses continue to occur at an alarming rate. multidisciplinary work, perioperative care
Recent research using the Institute for involves a high risk for these serious events.
Healthcare Improvement’s Global Trigger Tool Historically, efficiency has been a primary
found that one-third of adults and 40 % of pedi- focus of perioperative services, and quality and
atric patients admitted to hospitals experience safety may not have received the prioritization
an adverse event [1, 2]. For adults, the most fre- needed. This focus is changing, in part, because
quently identified events are well known to of external pressure surrounding public report-
perioperative clinicians, including medication- ing of harmful events and reimbursement tied
related, pressure-related, nosocomial infection, to quality. Of the 27 serious reportable events
pulmonary emboli/DVT, pressure ulcers, device identified by the National Quality Forum, five
failures, and falls [1]. Many of these events focus directly on surgery [6]. The Centers for
(32.5–40 %) were found to be preventable [2, Medicare and Medicaid Services (CMS) will
3]. Results of voluntary reporting also support no longer reimburse for the additional patient
that adverse events continue to occur in periop- care required to treat patients who sustain a
erative care. In 2014, unintended retention of a serious reportable event. CMS also attaches a
foreign body after surgery remained the senti- percentage of reimbursement to performance
nel event most frequently reported to The Joint on quality measures and a penalty to hospital-
acquired conditions and preventable patient
V.M. Steelman, PhD, RN, CNOR, FAAN (*) harm [7]. Clearly, there is an enhanced aware-
The University of Iowa, College of Nursing, ness of the importance of patient safety and
50 Newton Road, Iowa City, IA 52242, USA financial incentives to support implementation
of safety initiatives. The time is right for a con-
M.D. Stratton, MSN, MHSA, RN, CNOR, NEA-BC centrated effort to design perioperative ser-
Doctors Hospital of Augusta,
3651 Wheeler Road, Augusta, GA 30909, USA
vices to enhance the safety and quality of
e-mail: [email protected] patient care.

298 V.M. Steelman and M.D. Stratton
Building a Safety Culture Building a culture of safety begins with

assessment of the existing viewpoints of staff,
The design or redesign of perioperative services departmental leadership, and executive leader-
should start with a commitment to the principles of ship as well as the processes in place to address
safety and the establishment of a culture of safety patient welfare. There are several external
throughout the healthcare system. Components of comparative benchmarking surveys that can be
a safety culture focus on leadership, process and used to assess safety cultures. Tools that mea-
human factors elements, and how the interaction sure both leadership and staff perceptions give
of these elements provides a platform for safe a clearer picture of any disparities between
patient care. A systematic review of the literature policy and practice. The AHRQ Hospital
found that the most frequently identified concep- Survey on Patient Safety Culture measures
tual dimensions of a positive safety culture include: staff perceptions of patient safety culture in
their specific work area/unit, as well as percep-
• Leadership commitment to safety, tions about patient safety culture in the organi-
• Open communication founded on trust, zation as a whole [11]. Comparative database
• Organizational learning, reports are available to perioperative leaders
• A non-punitive approach to event reporting using this survey tool to evaluate progress on
and analysis, the journey to a patient safety culture [12].
• Effective teamwork, and This assessment should be conducted before
• A shared belief in the importance of safety. [8, and after restructuring and periodically to eval-
p. 340] uate the impact of initiatives to promote safety
and quality. It is essential to share the results of
Interventions to improve the safety culture are these surveys with perioperative personnel to
usually multifaceted bundles of interventions or a ensure they develop trust in management’s
program that targets more than one dimension. goals, and encourage their input into strategies
One approach is the Comprehensive Unit-Based to address opportunities for improvement iden-
Safety Program (CUSP) which was developed by tified in the results [13].
a team at Johns Hopkins [9]. This five-step pro-
gram is designed for department-by-department
implementation throughout an organization, but esigning the Infrastructure
D
with the responsibility for execution and program for Safety
maintenance remaining at the unit level. The five
steps of CUSP are: Once baseline information is gained about the
current culture, the next step is to design or rede-
1 . Train staff in the science of safety, sign the infrastructure to promote safety. This
2. Engage staff to identify defects, requires a top-down approach, integrating safety
3. Partner with senior executive leadership, and quality into all aspects of perioperative ser-
4. Learn from defects, and vices, including values, human resources man-
5. Implement tools for improvement. [9] agement, collaboration, and quality measurement
and reporting. Components of an infrastructure
Implementation of a unit-based safety pro- for safety are depicted in Fig. 19.1.
gram requires a team approach and staff mem- The mission of the perioperative care should
bers should have input into the development and be developed or revised to emphasize the impor-
ongoing performance of the team [10]. However, tance of safety and quality. It is essential that this
it remains incumbent upon the perioperative message be in alignment with the healthcare
leadership to assure that appropriate education, organization’s mission. Engaging practitioners to
assessment, and communication are provided as participate in the development or refinement of
the program progresses. the perioperative mission encourages a shared
19 The Leadership Role: Designing Perioperative Surgical Services for Safety and Efficiency 299
Fig. 19.1 Designing
perioperative services for
safety. Designing the
infrastructure for safety
requires integration of safety
into all aspects of the
organization
mental model of the importance of safety and about safety incorporated into job descriptions,
buy-in into subsequent changes. Displaying the which are then used for advertising vacant posi-
mission on the wall or as a screen saver provides tions and communicating during the hiring pro-
ongoing reinforcement of the importance of cess. Candidate interviews should utilize
safety and quality and sustainability of this as a behavioral-based questions that elicit the appli-
shared responsibility [14]. Having these signs cant’s understanding and experience with
visible to the public engages patients and may patient safety scenarios and working within a
also provide a competitive differentiation, inspir- team environment. During the hiring process,
ing patients to select the facility with the stronger the expectations of working within the organi-
commitment to safety and quality [15]. zation’s safety culture need to be clearly articu-
Incorporating patient safety and quality into the lated. While a candidate’s functional skill set is
strategic plan reinforces that this is a priority sup- important, the ability to assimilate successfully
ported by executive leadership, and facilitates into a safety culture is crucial. It is usually eas-
allocation of needed resources. ier to learn a functional skill than to learn team-
work and change attitudes. Integration of patient
safety and quality expectations into employee or
Hiring for Safety partner contracts prior to hiring or renewal is
valuable. Once hired, team members need to
A study conducted by the Health Research and thoroughly understand that safety and quality
Educational Trust found that utilization of high are a priority. Integrating these expectations into
performance work practices can improve patient the onboarding processes for hospital employ-
outcomes in both safety and quality parameters ees and contracted partners is essential. Video
[16, 17]. Building these high performance work clips from senior executive leadership provide
teams requires having the right people in the as strong message about the importance of
right jobs. This begins with having expectations safety and quality.
Promoting Safety Norms and the episodic nature of interactions, it can be

difficult to design a mechanism for meaningful
While executive leaders are responsible for estab- collaborative engagement. Most surgical settings
lishing safety as an organizational priority, unit- have a multidisciplinary committee charged with
based leaders are pivotal in assuring that patient overseeing the functioning of the operating room
safety processes are sustained as an integral part of and facilitating communication between periop-
perioperative care. Frontline leaders are strategi- erative disciplines. Key responsibilities of the OR
cally positioned to set performance standards and Management Committee include:
implement team-centered systems that support an
overall safety culture and meet safety goals. • Ensuring patient safety and high quality of
Providing ongoing reminders during daily hud- care to optimize patient outcomes
dles, and communicating progress toward goals on • Ensuring appropriate and timely access to
a Managing Daily Improvement board integrate perioperative services
safety into daily activities and establish it as a • Maximizing the efficiency of perioperative
norm. Staff meetings provide a valuable opportu- services
nity to discuss challenges and obtain staff input • Utilizing personnel and materials in a safe,
about strategies to overcome these challenges. cost-effective manner
These meetings should contain a standing agenda • Providing a safe work environment that pro-
item to discuss progress toward safety goals. motes collegiality, mutual respect, and effec-
Performance appraisals should include key tive teamwork
expectations of safety. However, addressing non-
compliance in a constructive, timely manner is criti- This committee’s meetings provide a venue
cal. Principles of a just culture should be used to for tracking the progress of safety initiatives and
address inconsistencies between desired behavior other key metrics and dedicated time for sharing
and observed behavior. This also provides input into safety concerns. Balanced scorecards are often
systems changes that promote desired behaviors. used for this purpose. The content of this report is
The perioperative team’s progress toward goals tied to the organization’s strategic plan. Although
should be shared with executive leadership. This these reports vary between facilities, some ele-
integrates perioperative safety into the overall qual- ments of a perioperative score care may include:
ity and safety program and instills a sense of account-
ability. This communication is often in the form of a • The associated strategic objective(s)
scorecard, aligning perioperative safety goals with • Key process measures (e.g., first case on-time
the overall strategic plan for the organization. starts, beta blocker at discharge)
Lastly, developing a safety culture at the surgi- • Incidence of adverse events by type or
cal microsystem is a journey requiring continu- hospital-acquired conditions (e.g., retained
ous reinforcement and support [18]. Progress surgical item, surgical site infection,
toward goals should be recognized and cele- readmission)
brated. Having healthy competition between • Adherence to a safety process goal (e.g., spec-
perioperative teams can serve as an additional imens correctly labeled, surgical procedures
incentive, and may make the journey toward a scheduled correctly)
safety culture more enjoyable. • Patients perceptions of care (e.g., Hospital
Consumer Assessment of Healthcare Providers
and Systems (HCAHPS))
The Role of the Operating Room • Employee metrics (e.g., RN turnover rate,
Management Committee employee satisfaction, use of agency personnel)
• Safety culture (staff perceptions of safety
In perioperative settings, all levels of providers culture)
should be involved in the journey to a safety cul- • Financial metrics (e.g., number of procedures,
ture. Due to the complexity of the departments cost of supplies, productivity)
Although membership of the OR Management gated for a clearer picture of the processes toward
Committee varies somewhat between types of a safety culture [20]. By examining harmful and
facilities and networks, the structure usually potentially harmful patient safety events and trend-
includes the triad of perioperative nursing direc- ing these over time can help pinpoint areas that
tor, anesthesia director, and surgeon director. need improvement in safety protocol adherence.
This oversight requires effective collaboration Information technology can also be utilized to
between members of the committee, sharing data “improve safety by providing decision support to
to and from their respective departments, dis- clinicians during the cares process, assisting pro-
cussing initiatives, and addressing issues with viders with missed diagnoses, and improving
their departments. Incorporating the committee compliance with evidence-based medicine” [21].
members into the ongoing surveillance of safety Robust process improvement is essential to a
initiatives helps to underscore the importance of culture of safety and information technology is
building and maintaining safety initiatives. essential to extract and synthesize data in mean-
ingful ways to provide a basis for examining cur-
rent practices and identifying areas for further
Collaborating for Safety development. Sustainability of a safety culture
requires a continuous focus on the process of
Executive Leadership safety and the resulting outcomes. Keeping rele-
vant safety data highly visible maintains an
The OR Management Committee should not only awareness of where the organization is progress-
manage down, but also manage up, partnering with ing and where opportunities for further progress
the senior executive leadership. This partnership toward safety goals exist toward a safe environ-
should include monthly safety rounds by the senior ment of care. It is best to have dedicated IT sup-
leadership, talking to staff members in each periop- port assigned to perioperative services to facilitate
erative area. This provides an opportunity for two- timely reports and accurate trending.
way communication. The frontline staff members
see the commitment of leadership to safety initia-
tives, and the executive hears from the frontline what uality, Safety, and Risk Management
Q
issues staff members face and recommendations for Departments
overcoming hurdles. This information is valuable
because senior executives have access to resources The role of Quality, Safety, and Risk Management
that can be deployed to address these issues. departments is essential in the investigation of
Effective perioperative leadership also adverse events and the trending of these occur-
requires a strong network of collaboration with rences to determine process failures and opportuni-
other departments, including the Information ties for performance improvement. Engaging these
Technology, Quality, Safety, and Risk departments in the overall oversight of a safety cul-
Management departments. ture is beneficial in aligning the organization’s focus
on the outcome of patient care and the resulting cost
to the patient and the organization of substandard
The Information Technology care [22]. Perioperative leaders should utilize the
Department expertise of these practitioners to enhance the edu-
cation and communication to their team regarding
Provision of data-driven reporting is integral to the efficacy of safe patient care practices.
tracking and trending the actual incidence of
adverse events as well as near miss occurrences
and progress on other patient safety goals [19]. Other Departments
The Information Technology department plays a
vital role in designing data abstraction processes to Building a wide network of collaboration with
capture multiple data elements that can be aggre- other organizational departments promotes a
b etter understanding of the unique characteristics Staffing Plan

of perioperative patient care and maximizes the
resources available to perioperative leaders in the Providing an appropriate number and mix of staff
execution and continuation of a safety program. starts with a staffing plan. The staffing plan should
This facilitates improving access to and timeli- be based on the complexity of patient care, com-
ness of perioperative services, and perioperative petency of staff, and surgical volume. The plan
efficiencies. For example, collaborating with the should set a standard for a minimum safe level of
Emergency Department is essential to promote staffing and have enough flexibility to adjust for
timely surgery for trauma and other emergency unforeseen circumstances. This plan should iden-
patients. Collaboration with the Intensive Care tify number of staff members, staffing mix, and
Unit minimizes issues with bed access. scheduling of personnel to be present in the unit
Collaborating with Material Services supports or on call. This staffing plan should be addressed
the availability of needed supplies and implants. in the perioperative budget [24]. Personnel should
not be required to work more than 12 h in a 24 h
period or more than 60 h in a work week [24]. The
External Partners use of 12 h shifts, compared to 8 h shifts, has been
found to be associated with an increase in fatigue,
Collaboration may also extend to external part- patient care errors, and worker injuries [24, 25].
ners. This can be done through the National Using these extended shifts should be avoided.
Healthcare Safety Network (NHSN), state report- The on-call staffing plan should include strategies
ing, Patient Safety Organizations, or collaborative to minimize extended work hours and provide
learning networks. Collaboration with other facili- relief for personnel working beyond 12 h.
ties allows the use of aggregate data collected from OR in-room staffing is calculated based on the
many facilities to enhance learning and drive number of concurrent rooms at various times of the
changes in safety and quality. By mid-2012, 27 work day, with additional support staff available.
states and the District of Columbia had enacted Minimum staffing for one operating room generally
legislation to establish collective reporting sys- consists of one registered nurse circulator and one
tems for adverse events or errors [23]. The CUSP surgical scrub person per operating room. However,
Learning Network is an example of network-based increasing case complexity and patient acuity indi-
collaborative learning in action. This network cate that this minimum number may not be suffi-
facilitates peer-to-peer learning and coaching [9]. cient for an ever increasing number and types of
procedures. In some settings, it’s not unusual to
have two or three persons in the scrub role due to
Staffing for Safety equipment and technology requirements. It is also
common to have two circulators for high patient
The availability of the perioperative team to man- acuity cases or procedures that require enhanced
age the daily schedule and acute emergencies is patient monitoring (e.g., laser or hybrid proce-
essential for patient safety. Having too few staff dures). The AORN has published guidelines for
for a patient surgery or having personnel who are safe staffing that include a formula for calculating
not competent in the particular aspects of the pro- the number of staff needed for an OR suite [24].
cedure and patient care requirements increases Some states have imposed mandatory staffing
the risk of harm to the patient. requirements based on either nurse–patient ratio or
Planning staffing for an operating room (OR) a facility committee-led approach, with direct care
is considerably different than for an inpatient care providers comprising more than half of the mem-
unit. While staff working in an inpatient unit care bers. An alternate approach used by some states is a
for multiple concurrent patients within a specific requirement to disclose staffing levels to an agency
medical specialty, OR staff care for patients or the public. Perioperative leaders must be knowl-
sequentially for multiple surgical specialties. edgeable and compliant with the laws in their states.
Table 19.1 Staffing requirements by level of trauma center designation [67]

Level I Level II Level III
Nursing OR team must be available OR team must be available OR team must be available
within 15 min (e.g., within 15 min (e.g., within 30 min
in-house 24 h per day). If in-house 24 h per day). If
the trauma OR is in use, the trauma OR is in use,
another team must be another team must be
available available
Anesthesia provider Available in-house 24 h per Available in-house 24 h per Anesthesiologist or CRNA
day. When anesthesiology day. When anesthesiology must be available within
senior residents or CRNAs senior residents or CRNAs 30 min
fulfill this requirement, the fulfill this requirement, the
attending anesthesiologist attending anesthesiologist
on call must be available on call must be available
within 30 min at all times, within 30 min at all times,
and present for all and present for all
operations operations
General surgeon General surgeon or Must be available within Must be available within
appropriate substitute (year 15 min, 24 h per day with 30 min
4 or 5 resident) must be in back-up call
house 24 h a day
Neurosurgeon Immediately available 24 h Must be available within Not required
per day with back-up call 15 min, 24 h per day with
back-up call
Orthopedic surgeon Must be available within Must be available within Must be available within
30 min 30 min 30 min
Other surgical service Must have a full spectrum Must have a full spectrum Not required
coverage of other surgical specialists of other surgical specialists
available (cardiac surgery, available (thoracic surgery,
thoracic surgery, hand hand surgery, microvascular
surgery, microvascular surgery, plastic surgery,
surgery, plastic surgery, obstetric and gynecologic
obstetric and gynecologic surgery, ophthalmology,
surgery, ophthalmology, otolaryngology, and
otolaryngology, and urology). Should provide
urology) cardiac surgery
Perioperative services should also be staffed ners working in perioperative services. Content
in a manner to adequately respond to emergent from perioperative leadership and executive lead-
patient needs. The responsiveness depends on the ership should be included. This can be done by
type of care provided. Hospitals designated as inserting a video clip into presentations. The con-
Level I trauma centers must have immediate tent of this education should include:
availability to provide a range of services.
Hospitals designated as Level II or III have lower • Safety is owned by the system
requirements (see Table 19.1). • Basic principles of safe design (standardization
of work, independent checks (checklists) for
key processes, and learning from mistakes)
ducating and Training in Patient
E • The importance of teamwork in safety [26]
Safety
A culture of safety also requires assurance that
Designing perioperative services for safety healthcare personnel have the knowledge and
requires an understanding of the science under- technical skills to make sound clinical decisions,
pinning safety. Education about safety should be perform tasks needed for their roles, routinely
provided for all personnel and contracted part- function as a team, effectively work together to
manage emergency situations, and maintain these is usually done through annual competency
skills over time. Simulation and spaced education assessment. Traditionally, personnel have been
are two strategies to accomplish this [27]. required to attend annual educational programs
about a set of expected competencies. This is
time consuming, and often dissatisfying to per-
Simulation sonnel that have attended the training multiple
times and believe that they have already mastered
Academic and healthcare facilities are rapidly the content. For these situations, spaced educa-
adopting simulation as a way to prepare healthcare tion (SE) is a valuable alternative. SE is an inno-
professionals for their direct patient care responsi- vative, evidence-based educational method that is
bilities, including care of the surgical patient. This very popular with busy perioperative personnel.
educational strategy provides a risk-free environ- SE involves delivering periodic e-mails or text
ment for individuals to learn how to make clinical messages containing clinical scenarios and test
decisions and develop technical skills for specific questions. Immediately after answering the ques-
tasks. Systematic reviews of surgical simulation tion, the learner receives the correct answer with
have found that the knowledge gained transferred an explanation of the topic. The question is then
to performance during surgery [28, 29]. A recent placed into a cycle, and repeated in 8–42 days, to
meta-analysis found that simulation also has a reinforce the content. When the learner answers a
positive impact on surgical time [30]. question correctly twice, the question is retired.
Multidisciplinary simulation has been effectively SE is based upon educational psychology the-
used to teach teamwork and crew resource manage- ories in which spacing of education and testing
ment in perioperative patient care [31]. In addition to enhance learning and retention. In randomized
providing practice for their skills, the multidisci- trials, SE has been found to improve knowledge
plinary experience teaches personnel what they can acquisition and boost learning, and improve
expect from other team members [32]. retention of knowledge for up to 2 years [38–40].
Multidisciplinary simulation has been found to This methodology is especially appealing
improve communication and teamwork in the oper- because it can be done in a few minutes at a con-
ating room [33]. It is also effective for teaching the venient time, rather than requiring attendance at a
knowledge and skills required for a variety of emer- traditional lecture. Qstream (https://app.qstream.
gency situations, such as managing anaphylaxis com/) has some applications of interest to periop-
[34]. It has been used to enhance preparation for car- erative leaders. Educators may also create their
diac emergencies and response in the operating own courses in Qstream (e.g., fire safety, deep
room to care of a patient with a ruptured aortic aneu- vein thrombosis prophylaxis, perioperative hypo-
rysm [35]. A study of a multidisciplinary simulation thermia, sleep apnea). Although the use of SE in
of an exsanguination emergency and team perfor- perioperative safety is in its infancy, it has enor-
mance found that the simulation resulted in better mous potential, particularly for annual compe-
understanding of team member roles, activation of tency assessment for nurses, surgeons, and
the massive transfusion protocol, and an improve- anesthesia providers.
ment in time spent performing clinically significant
tasks [36]. Simulation has enormous potential to
improve the safety of perioperative care [37]. Designing Processes for Safety
When implementing new programs or processes

Spaced Education or redesigning those in place in the perioperative
setting, it is important to identify potential fail-
It is also important to assure that perioperative ures and, when possible, proactively prevent
personnel maintain knowledge gained about how these from occurring. This strategy is a proactive
to handle unusual events (e.g., surgical fire). This risk analysis. Unlike a root cause analysis that
retrospectively examines a single failure, a proac- Table 19.2 Steps of a healthcare failure mode and effect
analysis (HFMEA)a
tive risk analysis involves a “deep dive” examin-
ing a process and identifying and correcting Step Key elements
potential failures [41]. In this way, the learning is 1. Define the Verify that the process to be
HFMEA topic studied is clear
from what could go wrong, rather than what went
2. Assemble the Should be multidisciplinary
wrong in single event [27]. Two tools to conduct
team Include representatives from all
a proactive risk analysis are: Failure Modes and affected areas
Effects Analysis and the VA Center for Patient Include subject matter expert(s)
Safety’s modification of this tool, a Healthcare and an advisor
Failure Mode and Effect Analysis (see Table 19.2) 3. Graphically Number each step and
[42, 43]. describe the subprocess
Using a proactive risk analysis is ideal when process Create a flow diagram of all
initiating a new type of surgical procedure. For subprocesses
example, an FMEA was used to analyze the pro- Verify that all processes and
subprocesses are included
cesses for intraoperative radiation therapy.
4. Conduct a List all potential failure modes
Starting with planning for the procedure through hazard analysis for all subprocesses
completion of the procedure, 57 different failure Rate the severity of injury should
points were identified. Using the hazard matrix, the failure occur, for each failure
interventions for preventing failures were mode (1–4)
prioritized, and included double checking, inter- Rate the probability of
occurrence of each failure mode
locks, and automation [44].
(1–4)
Using a proactive risk analysis is also valuable Calculate a hazard score by
for investigating current processes that are high multiplying the severity and
risk or have resulted in an adverse event. An probability (score 1–16)
HFMEA of managing surgical sponges to prevent Use the decision tree to
a retained sponge found 57 different potential fail- determine next steps
ure points during the process. Only 14 were asso- 5. Actions and Determine if the failure is to
outcomes eliminated, controlled, or
ciated with final count. The most frequent accepted
underlying causes identified were: distraction Identify action to be taken
(21 %), multitasking (18 %), and time pressure or Identify desired outcome
emergency (18 %). These causes are extremely Identify individual responsibility
difficult or impossible to control. Because knowl- Identify whether top
edge deficit was not identified as an underlying management has concurred
cause, the authors concluded that education would a
Adapted from VA National Center for Patient Safety. The
not be an effective strategy and they recom- basics of healthcare failure mode and effect analysis.
mended considering adjunct technology to assist Washington, DC: VA. http://www.patientsafety.va.gov/
professionals/onthejob/HFMEA.asp
with prevention of retained sponges [45].
approving the change. Although financial projec-

resenting a Business Case
P tions have been used in healthcare for decades,
for Safety the structure of this information into a business
case was first introduced by Leatherman and col-
Any new program or initiative to improve quality leagues in 2003 [46]. Based on modern finance
and safety has an impact on limited resources. theory, organizations will be more likely to
This might be in the form of cost savings, cost undertake and sustain initiatives that can be
avoidance, and/or increased costs of supplies, shown to generate a positive (or at least neutral)
equipment, or labor. Someone will question this financial return on investment. As healthcare
financial impact prior to recommending or resources have become increasingly restricted,
the use of a business case to depict anticipated Information Systems department may be required
costs has gained momentum. It has now become to create new reports, particularly when data are
a standard perioperative leadership strategy needed about patient outcomes.
[47–55]. For calculating some costs, it is useful to use
A benefit–cost analysis is a simplified formula published data sources. Swensen and colleagues
often used as a foundation for presenting a busi- used consensus to develop a list of examples of
ness case. The cost savings and costs avoided sources of financial data for hospital leaders to
(e.g., labor, supplies, length of stay, readmis- consider (e.g., [56]).
sions, drugs) comprise the numerator and are The University Healthsystem Consortium
divided by the cost of the proposed intervention, (UHC) used a combination of facility and pub-
which serves as the denominator. It is important lished data to conduct a benefit–cost analysis of
to assure that the cost savings and costs avoided an intervention to prevent retained sponges. For
are as complete as possible. this comparison, authors used facility data for
duration of surgical procedures and number of
retained surgical sponges. They based the cost of
Sources of Data a minute of operating room time and the cost of
intraoperative radiographs on published data [57].
Developing a business case requires data from At times, costs are difficult to measure and
one or more sources: internal facility data, pub- remain hidden, such as the time required for cer-
lished data, and estimated hidden costs. Examples tain tasks. An example is the time required to rec-
of data routinely available in facility reports to oncile surgical sponge counts. If reconciled, an
perioperative leaders are listed in Table 19.3. event report is not generated. One study mea-
Although many of these data are in existing sured these hidden costs by collecting the num-
reports, collaboration with the Hospital ber of minutes required to reconcile the sponge
count and estimating the percent of this time that
Table 19.3 Sources of data for developing a business was nonproductive operating room time [58].
case When possible, it is best to include an estimate of
Facility reports External data hidden costs. This may mean collecting data on a
Cost of equipment/supplies Operating room small number of events or tasks for inclusion as
time [68] an estimate in the business case.
Types and numbers of procedures Healthcare-
performed acquired
conditions [69]
inimizing and Managing
M
Duration of procedures Legal defense [70]
Legal settlements
Resistance
Length of stay
[71]
Number, frequency, and cost of State penalties for Changing human behavior is inherently difficult,
readmissions serious adverse even in the best facilities with the best teams [59].
events An initial step in promoting any patient safety
Cost of labor initiative is providing rationale for the need to
Types and incidence of hospital- change. This can be done by presenting either
acquired conditions
published evidence supporting the need for the
Types and incidence of adverse
events
practice change or internal data depicting an
Compliance with quality opportunity for improvement. Unfortunately,
performance measures education alone is usually inadequate to influ-
Hospital Consumer Assessment ence behavior [60, 61]. Although physicians,
of Healthcare Providers and nurses, and other perioperative personnel want to
System (HCAHPS) scores provide high quality, safe patient care, they also
Reimbursement face competing priorities. Unless these priorities
are aligned or realigned with patient safety and Maximize Efficiency

quality initiatives, complacency remains a stron-
ger force, passive or active resistance occurs, and The second strategy to minimize resistance is to
the outcome is inadequate adoption of the prac- make the desired behavior easier to do than the
tice change. Effective leadership in perioperative undesired behavior. When designing a practice
quality and safety requires an understanding of change, the processes should be as efficient as
this tension and implementation of successful possible, minimizing the effort required of busy
strategies for minimizing and managing resis- practitioners. Minimizing the steps required and
tance. A bundle of strategies used together maxi- incorporating the steps into current processes is
mize the potential for success [60]. likely to be more successful than the burden of
additional workload. Make the desired behaviors
easier and the undesired behaviors more difficult
Engage Emotionally or inconvenient. This can often be accomplished
by the location of supplies and equipment. For
The first strategy to minimize resistance is to example, if the goal is to eliminate the use of
assure an emotional connection with the safety razors for preoperative hair removal, place hair
initiative. The individuals making decisions that clippers closer to the point of use, and razors fur-
affect patient safety are often not in clinical prac- ther away. Personnel are less likely to walk the
tice and may be emotionally disengaged from additional distance to obtain a razor and will
the patient experience. This may also occur in eventually fall into a pattern of using the clippers
clinicians experience “initiative fatigue” and instead of razors. If the desired behavior is wear-
have become complacent or developed negative ing gowns and gloves when starting central lines,
attitudes. Presenting data alone does not provide placing these items with the central line catheters
the impact necessary to successfully influence encourages the desired behavior. When adding
change. Joseph Stalin said, “The death of one electronic documentation requirements, mini-
man is a tragedy. The death of millions is a sta- mize the number of key strokes required to com-
tistic.” When individuals are emotionally disen- plete the desired documentation. Consistently
gaged, the data are only numbers. When this involving end users in the location of supplies
occurs, leaders need to refocus the attention on and design of processes provides valuable insight
the individual patient experience. This can be into how to effectively maximize efficiency.
accomplished through storytelling, starting a
discussion from the patient experience of an
event, depicting the tragedy, before presenting Leverage Peer Pressure and Support
the data. This emotional engagement is a simple
yet powerful strategy and increases the sense of The third strategy for minimizing resistance is
urgency for the desired change. A classic exam- to leverage the use of peer pressure and support.
ple of storytelling is Josie’s Story, in which a This can be accomplished by engaging opinion
mother discusses the medical mishaps resulting leaders to serve as safety champions. The use of
in her 18-month-old daughter’s death in a hospi- opinion leaders has a strong theoretical founda-
tal [62]. This story is more powerful than dis- tion and is a strategy that has been used for
cussing the number of medical errors that occur many years for implementation of public health
annually. Following the patient story with the promotion programs. These individuals influ-
data extends the impact the single patient experience the opinions and motivations of others,
ence to other patients, making the data seem that change social norms, serve as a communication
much more compelling. Successful leaders in conduit back to change leaders, and accelerate
quality and safety often begin meetings with a the rate of behavioral change [63]. A meta-anal-
patient story, hardwiring this emotional engage- ysis including 19 studies of the effectiveness of
ment into the culture. using opinion leaders to drive evidence-based
practice changes found that alone or in combi- Dealing with Persistent Resistance

nation with other interventions, opinion leaders
may effectively promote practice changes [64]. It would be naive to think that there won’t be some
The selection of individuals to serve as opinion individual(s) who remains resistant to a change
leaders and safety champions should be based even though a bundle of strategies have been
upon their level of influence, with consideration implemented to promote adoption of a safety ini-
given to their position within the organization, tiative. Managing these individuals should prog-
professional expertise, communication skills, ress in a stepwise manner. First, one- on-one
and positive can-do attitude. These individuals discussions with the individual should be able to
should represent the multidisciplinary stake- determine the cause of the resistance. If the indi-
holders involved in the change. vidual does not believe that the practice change is
the right thing to do, providing more evidence is
helpful. However, if the individual just does not
Audit and Feedback want to do the desired behavior, providing more
evidence is likely to escalate the resistance. At this
One strategy to encourage compliance with clin- point it is helpful to listen to the individual’s ratio-
ical practice changes is audit and feedback [65]. nale, identify any barriers to adoption of the
Ivers and colleagues conducted a meta-analysis change, and continue the discussion at a later time.
to assess the effects of audit and feedback on the The second meeting should include a recap of the
practice of healthcare professionals and patient rationale for the resistance, any additional actions
outcomes, and to identify factors that explain taken to make the practice change easier, and then
variation in the effectiveness [66]. Seventy stud- a discussion of the expected behavior. If this is not
ies were included in the analysis. Audit and successful, the next step is reporting the issue to
feedback increased provider compliance with the individual’s immediate supervisor. Problematic
desired practices and improved patient out- behaviors may also be addressed in contracts with
comes. The effectiveness is more significant employees or partners upon renewal.
when baseline performance is low, the feedback
is given by a supervisor or colleague, the feed-
back is given more than once, when this feed- Summary
back is both verbal and written, and clear targets
for improvement are provided in an action plan Patient safety must be the highest priority for peri-
[66]. Written feedback can be provided through operative care. Designing perioperative services
managing daily improvement boards and score- for safety requires a top-down integration of safety
cards. Verbal feedback can be provided during into all aspects of work practices. This starts with
daily huddles or staff or committee meetings. senior leadership committed to safety as a priority.
The Association of periOperative Registered Inclusion of safety initiatives in the strategic plan
Nurses has an electronic audit tool, My and conducting monthly safety rounds demon-
AORNGuidelines (http://www.myaornguide- strates this commitment. Team members must also
lines.com/), that allows data entry at the point of be actively engaged in safety on a consistent basis,
use and real-time reports for feedback. My placing safety as the highest priority, particularly
AORNGuidelines provides an efficient method when faced with pressure for efficiency. A safety
of comparing practices with evidence- based culture requires having the right people in the right
guidelines. This tool can be used proactively for jobs, and starts with the hiring process.
comparing practices with evidence-based prac- Communication is essential. Discussing safety dur-
tice guidelines or to evaluate practices when ing huddles and team meetings keeps safety as a
investigating an adverse event. Progress over priority on a daily basis. Work processes should be
time can be measured as well as benchmarking proactively designed to minimize the risk of fail-
with other teams or facilities. ures, instead of relying solely on root cause analy-
ses after adverse events have occurred. And, 15. Song PH, Robbins J, Garman AN, McAlearney

AS. High-performance work systems in health care,
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safety and quality through human resources practices:
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Operating Room Management,
Measures of OR Efficiency, 20
and Cost-Effectiveness
Sanjana Vig, Bassam Kadry, and Alex Macario
“First rule of leadership: everything is your fault.”

—A Bug’s Life
OR managers (sometimes referred to as site

Introduction directors or schedulers) can potentially come
from surgery, anesthesiology, or nursing depart-
Everyone who works in an operating room (OR) ments and are responsible for making the best
suite sees inefficiencies they think should be cor- possible decision that allows for the most effi-
rected. When correcting for these inefficiencies, cient use of OR time and resources. OR decision-
it is important to keep in mind that the goal for making is an active and challenging process that
any surgical facility is to perform cases safely involves block time assignments, staff schedules,
and expeditiously. Common obstacles in an case duration predictions, and last-minute fluctu-
inefficient OR suite include long turnover times ations such as emergencies and add-on cases.
and unanticipated extended case durations. As a method of illustrating the variety of
Unfortunately, for these types of OR manage- obstacles faced by OR managers, several indi-
ment dilemmas, there is no one single answer viduals from different OR environments were
that applies to every facility. Although a quick asked to describe their day-to-day administrative
and effective solution is desired, a detailed diag- challenges (Table 20.1).
nostic analysis of a facility’s local issues is The goal of this chapter is to address the daily
required. This analysis will lead to corresponding challenges and to summarize key aspects of OR
local interventions to improve the issue at that management. Topics of interest include defining
facility. While gathering and analyzing OR effi- basic OR terminology, discussing case duration
ciency data is important, true success also predictions, addressing OR utilization and staff
depends on many unquantifiable variables, such management, and exploring measures of OR
as quality leadership and the effective manage- efficiency.
ment of human behaviors.
Basic Definitions [1–4]
S. Vig, MD, MBA (*) • B. Kadry, MD Since OR managers can come from different
A. Macario, MD, MBA departments, it is imperative that communication
Department of Anesthesiology, Stanford Hospitals occurs using precise vocabulary to ensure that
and Clinics, 300 Pasteur Drive,
there are no misunderstandings. Below is a list of
Stanford, CA 94304, USA
e-mail: [email protected]; common OR management terms with generally
[email protected]; [email protected] accepted definitions.

314 S. Vig et al.
Table 20.1 Examples of administrative challenges for individuals with OR management responsibilities
What is your biggest daily
Job title Facility type administrative challenge?
OR Schedulera Academic Medical Center Predicting future busy caseload days
to ramp up physician and nursing staff
ahead of time
Anesthesia staffing for emergent cases
outside of the OR
Medical Director Perioperative Academic Medical Center Managing long e-mail queue,
Services answering to all stakeholders
Addressing patient safety reports
(especially MD problem behaviors)
OR Schedulera Academic Medical Center Dealing with last-minute issues getting
patients into OR (e.g., after an
unexpected early case finish—logistics
of getting next case from waiting area
to holding to OR expeditiously)
Nurse Patient Care Manager Academic Medical Center Filling open salaried assistant nurse
manager positions
Filling open OR nurse positions
OR Data Analyst for Strategic Academic Medical Center Redistribution of block time to support
Development institutional growth
Aligning perioperative services to
match hospital priorities
Estimating resource needs to support
strategic vision
Senior Resident Scheduler Ambulatory Surgery Center Dealing with add-on (nonscheduled)
cases
Adjusting the schedule to
accommodate cancellations
Nurse Patient Care Manager Ambulatory Surgery Center Training new RNs for high complexity
cases
Having enough high priced equipment
(e.g., microscopes) readily available
when needed
OR Schedulera Community Hospital Allocating OR time to services and
making time for new surgeons
Scheduling inaccuracies: case booked
for 90 min but takes 3 h causing the
entire schedule to go out of sync
OR Schedulera Community Hospital Retention of staff and having
appropriate staffing levels
Ensuring the entire perioperative
process goes smoothly (e.g., have
every patient go to preoperative clinic)
Medical Director Freestanding Surgery Center Reassigning cases based on daily OR
efficiency
Stopping sick patients from being
inappropriately scheduled when are
better served at a hospital OR
a
OR scheduler: individual running the OR board for the day
20 Operating Room Management, Measures of OR Efficiency, and Cost-Effectiveness 315
Staffing: The process of calculating the num- group during allocated OR time, excluding turn-
ber of OR teams that must be available at each over times, divided by the allocated OR time.
time during the week. For example, there may be Adjusted Utilization: The total hours of elec-
staffing for four ORs Monday through Thursday, tive procedures, including the corresponding turn-
7 AM–3 PM, and 7 AM–12 noon on Fridays. over times, performed within allocated OR time,
Regular Scheduled Hours: The hours that an divided by the allocated OR time. For example, if
OR team member works on the days when not on allocated time is 8 h, case time is 6 h, and turnover
call (e.g., 7 AM–3 PM). is 2 h, then the adjusted utilization is 100 %.
Master Surgical Schedule: A cyclic timetable Underutilization: Reflects how early a room fin-
that defines how many ORs are available, the hours ishes and becomes idle. If OR staff are scheduled to
that the ORs are open, and the specific OR times work from 8 AM to 5 PM and a room finishes at
for individual surgical groups. Many surgical suites 2 PM, then there are 3 h of underutilized time. The
use a schedule that repeats every 1 or 2 weeks. excess staffing cost would be 33 % (3 h/9 h). Excess
Allocated OR Time: Specific OR time slot that staffing cost is one metric for assessing how well a
is assigned to a surgical group. For example, a spe- surgery suite is being managed.
cific group of neurosurgeons may be allocated OR Overutilization: The hours that ORs run beyond
time from 7 AM to 3 PM every Tuesday. This allo- allocated time. For example, if 11 h of procedures
cation does not mean that additional cases would (including turnovers) are performed with staff
be turned away if the group could not finish them scheduled to work 9 h, then there are two overuti-
by 3 PM. Instead, OR time allocation indicates lized hours. Overutilized hours are at least twice as
that the regularly scheduled hours planned for the expensive as regular hours because of the addi-
surgeons are between 7 AM and 3 PM. tional monetary and morale cost of staff staying
Block Time: A category of allocated, pro- late unexpectedly. The excess staffing cost here
tected, OR time. Procedures are electively sched- would equal 44 % (2 h/9 h equals 22 %, then is mul-
uled during a block only if they are predicted to tiplied by 2 to account for the incremental cost).
finish within the block.
Open Time: Hours of unreserved OR time dur-
ing which any service/surgeon can schedule Case Duration Predictions
cases/procedures.
Released Time: Hours of OR time released Predicting case durations is a difficult and frus-
from a service/surgeon’s block time and con- trating task. Even with large amounts of data
verted to open time. This usually occurs when it regarding a surgeon’s case performance history,
is known in advance that block time will be duration predictions for cases that have already
unused e.g., due to vacation or meetings. begun and for those yet to start are still poorly
OR (case) Time: Time span from when a estimated [5]. In fact, when graphing case dura-
patient enters the OR, until he/she leaves the OR. tion data, the distribution is not a standard bell
Turnover Time: The time from when one patient curve as might be expected (Figs. 20.1 and 20.2)1
leaves the OR until the next patient enters the OR. [6]. Unusually long cases will increase the aver-
Early Start: When a patient enters an OR age case duration estimate and skew the results to
before scheduled start time. the right. This occurs because case distributions
Late Start: When a patient enters occurs after do not provide a single point value for how long
scheduled start time. a scheduled case will last but, rather, provide a
Productivity Index: Percent of total elapsed probability estimate [6]. Therefore, when ques-
time that a patient is in the OR during prime time tioning how long a case has left, the answer is
(i.e., the first 8 h of the day) shifts.
Raw Utilization: The total hours of elective 1
Originally printed in “Anesthesia & Analgesia” Vol. 108,
procedures performed by a surgeon or surgical Issue 3, Jan 1, 2009.
316 S. Vig et al.
Fig. 20.1 Case duration data have

non-bell shaped distributions making
it difficult to choose a specific
number for how long a scheduled
case will last. The figure shows
differences in duration of scheduled
Hip procedures (Originally printed in
“Anesthesia & Analgesia” Vol. 108,
Issue 3, Jan 1, 2009)
Fig. 20.2 Case duration data

have non-bell shaped
distributions making it difficult
to choose a specific number
for how long a scheduled case
will last. The figure illustrates
scheduled Whipple
procedures. On the left are
cases in which the operation
was aborted; on the right are
cases that were fully
performed (Originally printed
in “Anesthesia & Analgesia”
Vol. 108, Issue 3, Jan 1, 2009)
better given as a percentage estimate. For exam- sis can transform scheduling by creating real-
ple, “There is a 62 % chance that the case in room time decision support for the OR manager. Such
6 will take another 30 min.” a system may be able to make recommendations
to an OR manager, such as: “Move the last case
from OR 3 to OR 10” or “Have the on call team
How to Make Duration Predictions take over in room 8” [6].
Current real-time estimates can be supple-
One method available to determine the duration mented by maintaining continuous communica-
of a case already under way is through Bayesian tion with OR staff on the status of ongoing cases
analysis. Bayesian analysis refers to the use of [6]. Regular updates are particularly valuable for
previous observations and current information to longer cases and those with few historical
help determine future events. A computerized comparisons [7, 8]. Approximately 20 % of sur-
scheduling system that employs Bayesian analy- geries in the United States are performed fewer
than 1000 times per year and 36 % are performed Inaccuracies may also result from improper
less than once a year per surgical facility [6]. scheduling of the procedure type. Each case is
Therefore, building a database with enough prior defined not only by the type of procedure and the
historical case duration data becomes difficult. surgeon, but also by the facility site. This is
Last 5 Case Estimate is a method of predicting because case times for the same procedure can
durations when there is limited historical data [8]. differ in an ambulatory center versus an inpatient
This procedure-surgeon specific method averages hospital surgery suite. Therefore, understanding
the durations of the last five similar cases per- the terminology used (e.g., are there incomplete
formed. For instance, if the surgeon has com- procedures codes), having an appropriate user
pleted at least five similar cases in the past year, or interface in computer scheduling programs, and
barring that, if any surgeon has performed the adequately training scheduling personnel is
same case, then those estimates are used to make imperative in accurately scheduling cases and
current predictions. Over- or underestimations are producing time estimates.
closely associated with certain factors, such as if Improving surgeon time estimates may occur
the case is an add-on, is performed after 5 PM, or by giving surgeons their own historical summary
is an outpatient procedure [8]. data and ensuring that they understand the termi-
Another method of predicting case durations is nology and the appropriate time frame estimates
to ask the surgeon to generate a time estimate [5]. to use [5].
However, their estimate may be biased due to a
facility’s scheduling policies. For example, at
some hospitals, surgeons may think it is necessary OR Block Time and Utilization
to provide shorter case time estimates to ensure
that scheduled durations do not exceed the end of One of the most important OR management deci-
the regularly scheduled block time. Conversely, at sions is to allocate the right amount of block time to
another institution, a surgeon may be biased to each service on each day of the week. This alloca-
lengthen case estimates to ensure that he/she does tion is based on historical usage by the surgeon and
not lose block time to another surgeon. computer analysis of data from similar cases. The
goal is to minimize the amount of underutilized
time and, the more expensive, overutilized time.
Improving Duration Predictions Figure 20.3 illustrates how allocated OR time
is broken down by cases performed, turnover
One approach to improve inaccurate case duration times, and resulting utilization patterns. In each
predictions is to first identify high volume cases OR, allocated time is 8 h. OR 1 has 1 h of under-
with highly variable case duration estimates (e.g., utilized time. In OR 2, the case time and turnover
spine surgery or sinus surgery) and compute the time lead to an hour of overutilization.
percent deviation of actual time from scheduled Determining causes of this inefficient OR time is
time. The next step is to define the source of this an important method to evaluate how well a sur-
variability. In other words, determine if the vari- gical suite is being managed.
ability occurs due to clinical differences in sur-
gery or if the data is inherently flawed. It is also
imperative to investigate how the data is collected. Surgeon Block Time
Some electronic systems consider incision time to
close time as the case duration, which then leads Generally, block times are given out in half or full
to future predictions based on that time frame. block intervals that can range between 4 and 12 h
However, duration estimates should include a [10]. Block lengths of 8–10 h are recommended,
patient’s room enter to room exit time as well [5]. though, to allow for more cases to be accommo-
Defining the nonsurgical time frames, room in to dated and to improve overall efficient use of OR
incision and surgical closure to room out, can help time [11]. Block time can be given to individual
improve scheduling accuracy. surgeons or surgical subspecialties as a whole
318 S. Vig et al.
Fig. 20.3 Illustration of OR definitions (Modified from [9])
[12]. However, assigning blocks to surgeons Block Time Allocation

instead of whole services can increase efficiency
and give surgeons a sense of ownership that Surgeons, or specialties, that underutilize their
encourages them to utilize their assigned time OR time are typically not given additional OR
efficiently [11]. Other advantages of surgeon- time. Instead, additional OR time is allotted to
specific block times include [10]: those specialties or individuals whose use of OR
time exceeds their allotment [10]. It is important
• The ability to ensure, in advance, that clinic to establish a usage threshold at which block time
days do not conflict with OR time. should be taken from one surgeon/service and
• Availability of appropriate surgical assistant reassigned to another. The next directive is to
staffing for given OR block times. determine to whom this freed up block time
• The ability to book the appropriate number of should be given.
procedures according to case length and Formulating solutions to these issues requires
complexity. aligning block times to the OR’s strategic vision.
The goal is not only to increase efficiency, but
Surgeon-specific block time can also be used also to allow certain specialties or surgeons to
to promote surgical growth by recruiting new sur- grow their practice. Achieving this entails assign-
geons and offering them dedicated block time. ing dedicated time, regardless of initial utiliza-
From a hospital’s perspective, block times for tion percentages. As a result, there is a potential
different surgeons can be spread out during the upstart cost to the facility in the form of hospital
week to accommodate the use of limited surgical and human resource support to get a group or sur-
supplies (e.g., if there is only one robot, then surgeon up and running.
geons who use it can be given blocks on different Viewing a facility’s OR network as an ecosys-
days so there is no conflict in use) [10]. tem can assist with case scheduling and block
allocation. Specifically, if one facility in a net- Impact of High Utilization

work has underutilized OR time, or not enough
case bookings, then it may be prudent to consider Improving utilization overall may help free up
diverting cases from another, busier, center in the additional OR time on any given day, which, in
network to the less busier OR suite. Evenly dis- turn, increases the flexibility of the daily sched-
tributing the workload can offset overutilization ule. This flexibility creates room to accommodate
in one place and help to fill in underutilized time unanticipated scheduling changes and avoid
in another. overutilization [11]. However, attempting to
increase utilization to 100 % can have a negative
impact by removing the ability to schedule cases
Block Time Utilization on short notice. As a result, patient waiting times
increase and may affect patient satisfaction. With
Raw utilization is computed by dividing the total this in mind, utilization should only be increased
hours of elective surgery time by the number of up to a certain point, where use of resources and
hours allocated for the OR block [13]. For exam- revenue are maximized in tandem and align with
ple, if a room finishes after performing cases that a facility’s independent goals [1].
totaled 7 h out of 8 h of block time, then utiliza- Efforts to increase OR utilization by schedul-
tion is 7/8 or 87.5 %. However, this method ing more inpatient surgery cases may not be pos-
penalizes surgeons with many short cases because sible due to other constraints, such as hospital
the turnover times are not included, thus underes- bed availability. Regular communication between
timating utilization. To compensate for this, the OR manager and hospital executives must
adjusted utilization is used: (raw utiliza- occur to determine which OR cases can be
tion + turnover) divided by allocated block time. allowed to proceed. This involves looking at the
Optimum utilization rates vary depending on total hospital census, including patients in the
the facility, the types of procedures commonly emergency room awaiting admission, projected
performed, and the facility’s independent man- direct hospital admissions and discharges, and
agement goals [14, 15]. Any analysis that discov- the limited available capacity in certain inpatient
ers suboptimal utilization in a facility may wards (e.g., ICU or telemetry) [5]. An available
indicate local issues with ineffective manage- countermeasure to optimize OR suite activity is
ment [11]. Low utilization may also be due to to prioritize outpatients or inpatients needing
operating more ORs than needed. Identifying and surgery.
addressing the underlying cause and working
closely with OR physicians is necessary for
developing effective solutions to maximize OR Decision-Making
utilization.
Utilization-Based Decisions
Case Scheduling While many will focus on utilization data to

make OR allocation decisions, it is important to
In general, a service or surgeon should not sched- take into account the individual situation of each
ule a case that runs into overutilized time if they healthcare system in question. Based on local
can place it in another OR without causing over- factors, different decision conclusions may be
utilization [3, 16]. Additionally, nonelective necessary. For instance, a facility that achieves
cases should be performed in a room that is unde- and reports high utilization may be performing
rutilized [3, 16], that is, if it is safe to otherwise cases with low contribution margins. As a result,
wait for one if it is not readily available. the finances for that facility may be negatively
320 S. Vig et al.
impacted. On the other hand, a facility with low Limitation Example

utilization may still have enough revenue stream High utilization may Increasing use of OR time
to make low utilization acceptable. This high- negatively impact increases wait times for
patient waiting time to patients needing surgery,
lights the fact that examining utilization data
have surgery decreasing the ability to
alone cannot accurately drive management deci- book cases quickly within a
sions. Table 20.2 lists limitations, and corre- few days when desired
sponding examples, to only using OR utilization Utilization does not Contribution margin
metrics for OR management decisions. correlate to profitability varies by
contribution margin surgical specialty [12]
Decision-Making Priorities
Table 20.2 Limitations of using only historical OR utili-
zation data for decision-making [10]
In regards to OR decision-making, the following
Limitation Example priorities can be followed as general rules [1]:
Inaccuracies in an Block times are usually
individual surgeon’s assessed every 3–6 months
• Patient safety trumps all other issues. Cases
utilization average [13]. However, longer
estimates intervals are required to should be arranged to maximize OR efficiency
obtain a true average [4] without risking patient harm.
e.g., if 3 months • Provide surgeons with access to OR time on
average = 65 % utilization,
any future workday, provided the cases can be
the Confidence Interval (CI)
is 38–85 % [10] done safely. This allows surgical procedures
Increased Once a long procedure (e.g., to be performed in a timely manner and pro-
underutilization for ENT cancer) is complete, motes flexibility and growth of surgeons’
specialties with longer the amount of block time practices.
procedure case times left may not be sufficient to
schedule a second case
• Maximize OR efficiency, i.e., reducing over-
Some specialties will Specialties with many urgent
utilization. Service-specific staffing is calcu-
not be able to have cases (trauma, cardiac) are lated to maximize expected OR efficiency. OR
high OR utilization less likely to have high time is released only when a service has filled
due to the nature of utilization than specialties its allocated OR time and still has another case
practice with predictable caseloads
months ahead of time (e.g.,
to schedule. The case is scheduled into the OR
joint replacements) time of the service with the most allocated but
Increasing utilization Not enough ICU beds can underutilized OR time.
may not be possible limit performance of certain • Reduce patient wait time on the day of sur-
due to other hospital cases so that OR utilization gery. Generally, patients are given specific
constraints appears low
arrival times based on when their surgeries are
High utilization rates If utilization is 90 %, there is
can inadvertently room for 10 % increase. scheduled. However, updated times may be
reduce overall hospital Hospital decides to accept needed if prior cases are cancelled or delayed.
revenue new, low reimbursement
insurance and adds many
new patients. With increased
waiting times, new patients Staffing
may actually replace full
payers, thus actually Over 60 % of hospital expenses are fixed costs for
decreasing revenues salaries and benefits of caregivers and ancillary
Utilization is not an Historical utilization does staff [1, 17]. This factor is one of the most impor-
indicator for potential not take into account the
future expansion future forecast of a surgical tant in driving up hospital spending [5, 13] and
subspecialty also incentivizes OR managers to maximize labor
(continued) productivity [1, 17]. This means using the least
amount of labor staff for the most OR cases pos-
sible, thus decreasing overall cost while increas- patient safety, and positive clinical outcomes.
ing overall revenue. As a result, maximizing OR Any behavior that disrupts these policies and
utilization and matching staffing with work case- affects these outcomes must be addressed, and
load becomes a priority [3, 17]. the physicians and staff involved must be held
OR allocations for a service, or surgeon, vary accountable [19]. It is important that everyone
by day of the week, and staffing also varies takes responsibility for their actions and is aware
accordingly, e.g., in 8-, 10-, or 12-h blocks [3]. of the consequences when expectations are not
While keeping in mind surgical needs, OR staff- met. Hand-in-hand with this is the need for posi-
ing can theoretically be determined based on cal- tive reinforcement for providers. Being rewarded
culating labor costs. For example, OR staffing for working harder, or taking on more responsi-
costs over a 4-week period, for specific services bility, can make implementation of change a
and day of the week, can be compared for an 8-h much smoother process and also heightens the
block with the cost of a 10-h block. If a surgeon sense of collaboration in the workplace.
or service has more than one OR day per week, Strong communication and listening skills are
then costs of two block time assignments, e.g., also essential. It is not just what is said that is impor-
two 8-h allocations or one 8- and one 10-h block tant, but also how it is said. Being aware of how one
allocation, can be calculated and compared. communicates can make a difference in how mes-
On the other hand, in some community-based sages are received and how effectively leadership
facilities, if utilization is low on a particular day, decisions are carried out [19]. In addition, identify-
shifts for full-time staff can be cancelled or the ing with the constituents, with their concerns or
staff can be sent home early. The challenge is complaints, can assist an OR manager in effectively
doing this fairly. Staff clinical workload and handling any issues that arise. This is particularly
exposure must be taken into account, as it is useful when negotiating the different behaviors and
essential that they are given the opportunity to values of nurses, doctors, and ancillary staff from
maintain their clinical skills. different generational age groups [20].
A driving factor for studying these interac-
tions is the occurrence of human error and the
Managing Staff impact of human behavior in the workplace [21].
Human fatigue, workload, poor communication
Successful management of the OR requires not and decision-making skills, ineffective leader-
only sound organizational structure, but also ship, and inability to work as a team can serve to
strong leadership, and interdisciplinary coopera- negatively affect work ethics and overall work
tion [18]. Common problems that arise when satisfaction and motivation [22].
attempting to lead physicians and ancillary staff While correcting for human error and honing
include [18]: nonclinical skills is important, it is also impera-
tive to realize that one can only correct for human
• Reluctance and lack of motivation to assist in behavior up to a certain point. The rest of the
change. managerial focus should surround the much more
• Placement of blame on others; lack of easily controlled design and flow of the OR work
accountability. environment [22].
• Lack of physician discipline.
Firm institutional policies with clearly defined OR Efficiency

provider roles allow OR managers to handle dis-
ruptive physician behaviors in an objective and Calculating Efficiency
rational manner. In addition, staff must be edu-
cated on these policies and procedures and be When determining how efficient (or ineffi-
kept up to date on any changes that occur. The cient) an OR is on a particular day, under- and
overall goal is to maintain patient satisfaction, overutilized times need to be computed [14].
322 S. Vig et al.
Taking the example mentioned earlier, if 7 out focus on lowering the percentage of patient inju-
of 8 h of a block are used, then 1 out of 8, or ries (e.g., fewer wrong-sided surgeries).
12.5 % of the block, is underutilized. At most A method to measure OR efficiency and per-
facilities, OR nurses are full time hourly or formance is through scorecard rating systems.
salaried. Therefore, the incremental labor cost Table 20.3 is an example of a scorecard that can
from 1 h of underutilized OR time is negligible be used to assess OR efficiency [24]. Suggested
[1]. This is called a “fixed” cost as they are parameters include staffing costs, late start times
paid for that hour regardless of whether or not for elective cases, case cancellations, PACU
they are in a case. delays, turnover times, and case duration predic-
If an OR runs late, for instance by 2 h, then tion biases. For poorly managed OR suites one
2/8, or 25 % of the block, is overutilized. This is would expect a score of 0–5 points (on a 0–16
then multiplied by a fudge factor of “2” to scale) [24]. High scores of 13–16 are especially
account for staffing costs for those additional 2 h achievable with the help of state-of-the-art man-
[13]. As a result, inefficient use of OR time is agement systems. Unfortunately, variations in
related to overutilized block time, which OR data systems, data fields, and data definitions
managers should, therefore, strive to minimize exist between hospitals, which can make external
[23]. A survey of OR directors showed that mov- benchmarking difficult [23].
ing cases from one OR to another to decrease
overutilization was only worthwhile if the time
saved was more than 1 h [1]. Table 20.3 Discussion
Case Cancellations
Goals of Efficiency Case cancellation rates include same day can-
cellations and, depending on the type of facility,
Each facility can, and should, have different must be viewed through different lenses.
goals regarding efficiency that are unique to its Surgeons may be more comfortable with can-
own circumstances. Each facility has its own celling/rescheduling inpatients versus outpa-
unique patient and surgeon population whose tients. Outpatient procedures may be more
characteristics and contributions to a hospital complicated to cancel because the facility does
must be balanced with the overall well-being of not expect, nor is prepared to fill in, for any can-
that facility. cellations. In addition, cancelling outpatient
procedures can have a large impact on patients
themselves. Many take time off from work and
Measures of OR Efficiency ask for special transport assistance. Thus, an
outpatient cancellation can mean a frustrating
Measures of efficient day-to-day scheduling and loss of time and money.
OR managing efforts can vary depending upon Case cancellations can also call into question
whom you ask within the hospital infrastructure. the value of the preoperative patient assessment.
For example, administrators concentrate on effi- If a patient is cleared by the preoperative clinic,
cient use of budgets or measured throughput, then it is assumed that the anesthesiology team
while surgeons aim for fewer cancellations and will proceed with the case.
more accurate first case start times [23, 24].
Nurse managers may focus more on maintaining PACU Delays
the flexibility to move cases around, and having PACU duration is not associated with quality of
adequate reserve capacity for add-on cases or care. Attaining accurate metrics requires obtain-
emergencies. In contrast, risk management may ing measures of when patients are ready to be
Table 20.3 An example of a scorecard that can be used to assess OR efficiency (with permission from Macario, Alex,
“Are Your Hospital Operating Rooms “Efficient”? A Scoring System with Eight Performance Indicators” Anesthesiology
Vol. 105, Issue 2, Aug. 1, 2006)
A scoring system for OR efficiency
Points
Metric 0 1 2
Excess staffing costs >10 % 5–10 % <5 %
Start time tardiness (mean >60 min 45–60 min <45 min
tardiness per OR per day)
Case cancellation rate >10 % 5–10 % <5 %
PACU admission delays (% of >20 % 10–20 % <10 %
workdays with at least one
delay in PACU admission)
Contribution margin (mean) <$1000/h $1000–2000/h >$2000/h
per OR hour
Turnover times (mean setup >40 min 25–40 min <25 min
and cleanup turnover times for
all cases)
Prediction bias (bias in case >15 min 5–15 min <5 min
duration estimates of OR
time)
Prolonged turnovers (% of >25 % 10–25 % <10 %
turnovers that are more than
60 min)
Originally printed in “Anesthesiology” Vol. 105, Issue 2, Aug. 1, 2006
discharged from the PACU and not when they nurses versus patients, surgeons, or anesthesia.
actually leave. Delays are often due to nonclini- Causes due to different groups are presented in
cal reasons, including nursing staff and number different formats to remain relevant based on
of physical beds. Another important measure is user archetype.
the PACU bay to OR ratio. This is especially
relevant with cases of shorter duration, as they
will quickly fill up PACU beds, which can then Conclusion
lead to PACU admission delays from the OR.
People involved in the OR suite need to believe
the data that is presented by OR managers when
OR Summary Data change is being proposed or implemented. This
requires standardized measurements across the
OR data can be summarized for the decision hospital system’s OR suites so everyone is using
makers, as seen in Figs. 20.4 and 20.5. the same data definitions. Often times, data is not
There are multiple factors that determine enough to drive change as there may be organiza-
whether a case will be able to start on time, tional and workplace cultural barriers that need to
including room ready time, and preoperative be addressed. Effective leadership skills are
issues such as difficult intravenous access, com- instrumental to motivate and inspire teamwork
plex patient histories, and patient arrival delay. and ensure cooperation with any new changes or
Having this kind of report allows differentiation updates to OR management processes. Ultimately,
of ownership of the cause of delay, i.e., OR the goal of any OR is to complete its cases in as
Fig. 20.4 This report was created in order to have a sim- Room” time correlates with the beginning of OR time
ple to understand, automated, timely display of late case allocations, which is a driver for staffing support. “Room
starts reported as a percentage relative to total case vol- ready” represents when the OR nurses communicate with
ume on any given day. Prior reporting occurred in general- preoperative staff that the room is ready to receive the
ized statements, such as “13 % of cases were late on patient as defined by having the appropriate supplies,
Monday, October 10,” which were unsatisfying and did equipment, and staff. “In room + 5 min” is the grace
not allow for understanding of the underlying issues. This period, of which, according to the table, includes 88 % of
figure illustrates a detailed service-by-service breakdown, cases. A grace period helps to differentiate cases that are
assigning ownership to late groups and allowing further truly late versus those that have been purposely scheduled
investigation into why any delays were occurring. The “In to start late, e.g., at 8 AM
Fig. 20.5 The idea behind this is to have an overall view ing and attempting to solve any issues with prolonged
of not only how many turnovers are occurring, but also turnovers. Different services have different case require-
how much time they utilize. As can be seen, turnover ments, thus, increased turnover time may be necessary,
times vary greatly amongst different service blocks. It is and accepted, to ensure appropriate preparation for
important to keep these differences in mind when address- surgery
efficient a manner as possible while optimizing 11. The right strategies can help increase OR utilization.
OR Manager [Internet]. 2013;29(5):1–4. http://www.
use of staff and resources and maintaining posi-
ormanager.com. Accessed 4 Nov 2015
tive patient experiences and outcomes. 12. Macario A, Dexter F, Traub R. Hospital profitability
per hour of operating room time can vary among sur-
geons. Anesth Analg. 2001;93(3):669–75.
13. The costs of caring: sources of growth in spending for
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The Science of Delivering Safe
and Reliable Anesthesia Care 21
Maurice F. Joyce, Holly E. Careskey, Paul Barach,
and Ruben J. Azocar
“Patient safety is truly the framework of modern anesthetic practice, and we must
redouble efforts to keep it strong and growing.”
—Ellison C. (Jeep) Pierce, Jr., M.D.; Founding Leader of the APSF
EHR Electronic health records

Abbreviations FDA Food and Drug Administration
FMEA Failure mode and effects analysis
AAR After action review
ICU Intensive care unit
ABA American Board of Anesthesiology
MOCA Maintenance of certification in
AfPP Association for Perioperative Practice
anesthesiology
AIMS Anesthesia information management
MPOG Multicenter Perioperative Outcomes
systems
Group
AIRS Anesthesia incident reporting system
NACOR National Anesthesia Clinical
AORN Association of Perioperative Registered
Outcomes Registry
Nurses
NQF National Quality Forum
APSF Anesthesia Patient Safety Foundation
OSCE Objective structured clinical
AQI Anesthesia Quality Institute
examination
ASA American Society of Anesthesiologists
PPAI Practice performance assessment and
CCAP Closed claims analysis project
improvement
CMS Centers for Medicare and Medicaid
PQRS Physician quality reporting system
Services
PSH Perioperative surgical home
CRM Crisis Resource Management
QCDR Qualified Clinical Data Registry
DISS Diameter index safety system
RCA Root cause analysis
SCIP Surgical Care Improvement Project
SRE Serious reportable events
M.F. Joyce, MD, EdM • H.E. Careskey, MD, MPH
R.J. Azocar, MD, MHCM, FCCM (*)
Department of Anesthesiology, Tufts Medical Center,
800 Washington Street, Box 298, Boston,
MA 02111, USA
Introduction
[email protected];
[email protected] The approach to providing safe perioperative
P. Barach, BSc, MD, MPH, Maj (ret.) care starts with a common goal. The delivery of
Clinical Professor, Children’s Cardiomyopathy anesthesia entails working within several com-
Foundation and Kyle John Rymiszewski Research plex, multifaceted systems. An effective and safe
Scholar, Children’s Hospital of Michigan, Wayne State
system is one that is consistent between patients
University School of Medicine, 5057 Woodward Avenue,
Suite 13001, Detroit, MI 48202, USA and effective at identifying and preventing errors.
e-mail: [email protected] The design and implementation of safe processes

328 M.F. Joyce et al.
is essential to prevent mistakes. Anesthesiologists share about their work environment” as defined
are involved in the care of patients in a myriad of by Zohar [4]. Safety climate is generally the
locations from the preoperative assessment to the accepted term for the collective view of safety
perioperative and postoperative periods. within an organization as manifested by recent or
Additionally, anesthesiologists have a large pres- current events. In other words, the safety climate
ence outside of the operating room including in can be considered an immediate antecedent to
the intensive care unit (ICU), inpatient wards, behavior. An organization’s employees are often
and outpatient pain clinics. Each of these loca- driven to action, or inaction, based on their per-
tions has its own set of standards, protocols, ceptions of reality driven by the safety climate.
safety measures, and cultures. Safety climate is often significantly influenced by
The primary goal of anesthesia care is to recent events. For example, the safety climate of
deliver safe care and avoid process failures which an organization can experience an immediate
lead to never events [1]. These are events defined negative impact if a major workplace event such
as “serious, largely preventable patient safety as a fatality occurs. Although this event may
incidents that should not occur if relevant preven- eventually also impact the safety culture, it could
tive measures have been put in place” [2]. have a significant latency and its long-term
Secondary goals include providing high quality impact may require years to accurately evaluate
care in an efficient manner for every patient. To [5]. This culture can greatly improve the trust
attain these goals there are technical solutions between members and between workers and
including medical device and medication fail- management, and influence willingness to speak
safe measures as well as process solutions includ- up, collaborate, and work more effectively as sur-
ing checklists, crisis resource management gical team members [5].
protocols, and incident investigation. Establishing A “reporting culture” is at the heart of engen-
and following evidence-based standards and pro- dering safety and only really works when work-
tocols, we can attempt to prevent mistakes made ers feel free to report their errors and near misses
by fallible, albeit well-intentioned, providers. to management without punishment [6]. The
Deviation from an established protocol or stan- most important organizational value that sup-
dards should be rare and require justification. ports a reporting and learning culture is when
employees feel psychologically safe, and if they
speak up to report on process or outcome failures,
esigning and Enabling a Culture
D they will not be censured or suffer reprisal [7, 8].
and Climate of Safety In this environment, errors are not only reported
but are also dissected without assigning blame
The phrase “culture eats strategy for breakfast”, a and subsequently steps are taken to prevent them
phrase originated by business guru Peter Drucker, in the future. This type of environment has been
is well known by administrators trying to imple- described as a learning environment and, in con-
ment change. The term “safety culture” was junction with concrete learning processes and
coined after the Chernobyl incident in the town practices, is the first step towards creating a learn-
of Pripyat, in Ukraine in 1987. Although many ing organization [9]. Another key aspect of safety
definitions exist, the definition by Turner et al. is in nonmedical industries is incident reporting
most applicable to healthcare: “the set of belief, systems that focus on near misses. Reporting of
norms, attitudes, roles and social and technical near misses offers numerous benefits over adverse
practices that are concerned with minimizing the events: greater frequency allowing quantitative
exposure of employees, managers, customers and analysis; fewer barriers to data collection; limited
members of the public to conditions considered liability; and recovery patterns that can be cap-
dangerous or injurious” [3]. tured, studied, and used for improvement [10].
Safety climate, however, refers more to “a The final essential component needed to
summary of molar perceptions that employees enable a culture of safety is leadership that
21 The Science of Delivering Safe and Reliable Anesthesia Care 329
reinforces learning. When leaders actively ques- v igilance, unit efficiency concerns, and employee
tion and listen to employees, spend time on prob- empowerment [17]. Limiting the resolution pro-
lem identification, support knowledge transfer, cess to individual vigilance alone may lead to
and reflective post-audits, employees feel reas- solutions for the immediate issue at hand but not
sured to offer new ideas and options [11]. address systemic problems. An excessive focus
Reason in his “Swiss cheese theory” described on efficiency may lead to safety problems, thus it
the negative outcomes that occur when system must be emphasized that safety trumps efficiency
barriers fail, allowing actions to penetrate the [18]. Clinician empowerment is enabled when
organizational barriers, and thus the holes of the the communication from management is authen-
Swiss cheese slices align. Analyzing process and tic and the actions they are asked to undertake
outcome failures in which patients are harmed make sense to them—we call this clinical sense-
can be done using a variety of methods including making [19]. Individuals will only feel empow-
root cause analysis (RCA) sessions, where the ered to maintain open communication with
organizational, cultural, and technical roots of leadership if leadership is fully committed to the
the failure process are discussed and recommen- process and the staff understands why particular
dations for future prevention are generated [12]. actions and interventions are being supported and
Failure mode and effects analysis (FMEA) is deployed [20].
another systematic technique that can be utilized
to assess a complex clinical socio-technical pro-
cess such as a liver transplant operation and iden- quipment and Monitoring
E
tify à priori which steps in the clinical process Advances
are most likely to fail and lead to harm [13].
Organizational psychologists advocate debriefing The administration of anesthesia is predomi-
all critical or high-stakes events. For example, the nantly a complex monitoring task and relies on
U.S. Army After Action Review (AAR) is a struc- an integrated anesthesia workstation that has
tured debriefing process for analyzing what fail- evolved over time through tremendous techno-
ure happened, why it happened, and how it could logical advances [21]. This evolution includes
have been done better by the participants and scientific improvements related to anesthetic
those responsible for the project or event [14]. delivery and patient monitoring as well as the
Healthcare organizations continue to have addition of enhanced safety measures. Multiple
high variation in their patient outcomes and need gases are utilized in the operating room in the
to make significant progress before they can be delivery of anesthetic and surgical care. It is criti-
regarded as learning and high reliability organi- cal that swapping of agents is prevented.
zations [15]. Tucker and Edmonson explain that Unintentional swapping of the gas supply can
in order to create a trustful environment three fac- lead to serious harm in the form of delivery of a
tors must be present: (1) Management support hypoxic gas mixture to a patient, increased risk of
(not only in voice but also demonstrated by a intraoperative fires, and inadvertent expansion of
presence “in the field,” experiencing and witness- closed chambers. The most common gases
ing the problems firsthand); (2) Creation of an required during anesthesia delivery include oxy-
environment where individuals can provide feed- gen, air, and nitrous oxide. Less frequently, addi-
back without fear of embarrassment or punish- tional gases are used including nitric oxide,
ment; and (3) Follow-through based on employee helium, and xenon. Carbon dioxide is often used
observations or suggestions, thus allowing indi- for insufflation during laparoscopic surgeries.
viduals to see the organizational reaction to their The development of several safety measures
participation [16]. The barriers to creating a has made the delivery of an unintended gaseous
learning organization include physician burnout agent less likely to occur [22]. Foremost among
and even practices that are sometimes considered these measures is engineered redundancy includ-
positive, such as an emphasis on individual ing delivery and transport of the correct agent in
color-coded pipelines and cylinders, ventilator ventilation and leak tests. Each anesthesia
gas analyzers, and continued monitoring of agent machine contains an oxygen pressure sensor that
purity in the central gas supply. Medical gases are alarms if the oxygen input is below a set thresh-
delivered to the operating room in two different old. The position of the oxygen control knob is
ways. They are delivered to various locations in a always closest to the breathing circuit. If there is a
healthcare facility from a central supply through a leak from “upstream” gas inlets, the distal posi-
series of pipelines. These pipelines can be tion of oxygen inlet allows for an adequate oxy-
accessed through outlets in each operating room gen supply to reach the patient. Additional safety
suite. The hoses for each of these pipelines are measures built into the ventilator include minimal
color coded according to national standards oxygen flow, end-tidal gas monitoring,
adopted by Bureau of Standards of the US oxygen:nitrous oxide controller, and pressure
Department of Commerce [23]. Connection of the regulators.
pipeline hose to the anesthesia machine is The American Society of Anesthesiologists
achieved with a unique fitting specific to the gas (ASA) initially published standard monitoring
being attached known as the diameter index safety guidelines in 1986. These standards were devel-
system (DISS). These unique fittings prevent the oped to help providers more readily recognize a
wrong hose from attaching to the ventilator. A decompensating patient as well as provide a min-
unidirectional valve at the hose terminal prevents imal universal standard of care. The guidelines
the backflow of gases. An opportunity for error have been updated as medical technology has
exists if gases are interchanged in the central sup- advanced. Today, the guidelines include that an
ply source. The second method of gas delivery is anesthesia provider must be present for the dura-
through the use of gas storage cylinders [1]. These tion of the anesthetic. Monitoring standards are
cylinders, like the pipeline hoses, are color coded such that during all anesthetics, the patient’s oxy-
according to national standards. The cylinders can genation, ventilation, circulation, and tempera-
be attached to the end delivery device (i.e., venti- ture are continually evaluated [24]. Oxygen
lator, insufflator) through a specific fitting known delivery must be measured using an oxygen ana-
as the pin index safety system. The yoke manifold lyzer and an alarm for low oxygen concentration
on each cylinder contains a pin connection that must be used (notably, both are present on mod-
fits into corresponding socket in the delivery ern anesthesia machines). Quantitative measure-
device. The room for error exists should the pins ment of oxygenation, most commonly using
become damaged or the cylinder becomes filled pulse oximetry, is necessary. Monitoring of ven-
with the incorrect agent. Overlapping and redun- tilation is done through qualitative assessment
dant layers of safety measures is a key theme (for example, chest rise and breath sounds) as
within anesthesia safety that is repeated time and well as quantitative assessment of end-tidal car-
again. bon dioxide. End-tidal gas monitoring is included
The ventilator itself contains several mecha- in the standards and provides a means of early
nisms to ensure proper functioning and prevent recognition of esophageal intubation. Circulation
inadvertent delivery of hypoxic mixtures. Before is measured with continuous telemetry and
each patient encounter, an anesthesia machine through frequent blood pressure measurements
checklist must be performed (see Fig. 21.1). This (at least every 5 min). Temperature is to be moni-
checklist includes a minimum set of standards tored when changes in patient temperature are
that are developed and occasionally revised by the anticipated. While the guidelines provide a mini-
U.S. Food and Drug Administration (FDA). The mal standard, there is freedom to employ addi-
checklist includes verification that there are at tional monitoring methods should providers
least two oxygen sources (usually an emergency- deem them necessary for patient care.
cylinder and pipeline from central supply), cali- The development of monitoring guidelines
bration of an oxygen sensor, confirmation of was an early step in automating aspects of care
functional unidirectional valves and simulated so the provider could be quickly alerted to
Fig. 21.1 APSF Pre-Anesthesia Checkout Guidelines. permission from Anesthesia Patient Safety Foundation:
Apsf.org [Internet]. New Guidelines Available for Pre- http://www.apsf.org/newsletters/html/2008/spring/05_
Anesthesia Checkout. [cited 01 Feb 2016]. Reprinted with new_guidelines.htm
changes in a patient’s condition. Unfortunately

the multiple and lack of connected monitoring Anesthesia Information
alarms leads to a phenomenon known as alarm Management Systems
fatigue [25]. This occurs when the provider
becomes desensitized to the monitor alarm and The intraoperative electronic medical records
ignores new onset alarms. Alarm fatigue has that are becoming standard practice throughout
been listed as a top patient safety concern of the the United States are known as anesthesia infor-
Joint Commission as described in the 2014 mation management systems, or AIMS.
National Patient Safety Goals which require Implementation has been influenced by the adop-
hospitals to explicitly address alarm fatigue and tion of electronic health records (EHR) through-
be held accountable from 2016 [26]. Addressing out other aspects of the medical system after
this challenge will require many steps at differ- passage of the 2009 Health Information
ent system levels [27]. Monitoring devices that Technology for Economy and Clinical Health
process complex data streams should produce act. Additionally, governmental incentive pro-
clinically relevant alarm signals, in environ- grams, namely meaningful use from Medicare
ments optimized for discernment and attribu- and Medicaid, are encouraging providers to par-
tion, with user interfaces designed for timely ticipate in meaningful use programs [28]. These
interpretation, prioritization, and prompt action. computer-based documentation records are tak-
Alarm fatigue solutions require regulators, man- ing the place of paper charting of vital signs, pro-
ufacturers, and clinical leaders to recognize the cedures, and medication administration in the
importance and context of human factors and operating room as well as labor and delivery
their effects on staff behavior. anesthesia and acute pain documentation
e lsewhere in the hospital. A proposed benefit of are often not feasible in the operating room. In the
an AIMS is that it allows the provider to focus operating room, prompt medication delivery is
more attention on caring for the patient and less often necessary due to rapidly changing patient
on documentation. Additional benefits include condition, thus precluding these safety measures
the ability to mine data for quality improvement, and leading to medication administration errors.
automated billing, help with compliance mea- Since the same safety measures that are used else-
sures and research capability [29]. where are often unfeasible in this unique environ-
There are certain established concepts that any ment, there must be novel approaches toward
AIMS product should possess in order to be an minimizing medication errors.
effective tool for the anesthetist. These include Nebeker et al. define a medication error as the
automatically uploading data from physiologic inappropriate use of a drug that may or may not
monitors, the ability to take and store records result in harm [33]. An adverse drug event is
throughout the continuum of perioperative care defined as harm caused by the inappropriate use
including preoperative history and physical exam of a drug [33]. When a medication is used prop-
and postoperative recovery, automatic documenta- erly with a subsequent adverse outcome, it is
tion necessary for billing, and automated remind- known as an adverse drug reaction [33]. Examples
ers for quality assurance measures (for example, of common medication errors within the operat-
antibiotic administration timing). Additional func- ing room include incorrect dosage, incorrect
tionality includes clinical decision support, cus- medication, and wrong site administration. These
tomizable templates, automated alerts, and errors are multifactorial in nature and are related
institutional EHR integration. The ability of elec- to poorly designed medication labels and fonts,
tronic records to improve anesthesia safety seems vial sizes, and unaddressed human factors includ-
evident when compared to the tedious task of ing the long history and culture of the anesthetist
paper charting, though future research should working in isolation to draw up, dilute, label, and
investigate this area as AIMS become increasingly administer all medications involved in an anes-
utilized. The system must be optimized with phy- thetic delivery with little to no oversight.
sician workflow in order to be a useful tool and not In one large, single institution prospective
a barrier to care. Perioperative outcomes research study, the most common medication errors were
using anesthesia information management sys- labeling errors, wrong dose errors, and omitted
tems (AIMS) is an emerging research method that medication/failure to act errors [32]. The most
can offer a much better understanding of anesthe- common medications associated with errors in
sia complications [30]. Finally, deploying AIMS the operating room were propofol, phenyleph-
offers examples of unintended consequences rine, and fentanyl. Other studies have shown that
related to errors and security concerns, and issues neuromuscular blocking agents and opioids are
related to alerts, workflow, ergonomics, and qual- the most common associated agents [34]. Other
ity assurance [31]. types of errors include incorrect route of admin-
istration (for example, epidural instead of intra-
venous) or wrong site administration (for
Medication Safety example, bolus through a carrier line). In addi-
tion to the unique environment of the operating
The operating room is a unique environment room, anesthesiologists are also at risk of the
without many of the standard safety protocols that same medication errors and subsequent adverse
exist elsewhere in the hospital. In fact, medication drug events that occur throughout the hospital
errors in the operating room have been reported to due to poorly designed systems and safeguards.
be as high as one in 20 perioperative medications A review of the literature in 2007 concluded that
administered [32]. For example, pharmacy common risk factors for medication errors
approval and preparation of medication and two include the lack of knowledge regarding the
person checks prior to medication administration medication or the patient history by providers,
errors in the clinical chart or nursing documenta- medical care [40]. However, until recently, the
tion, and decentralized pharmacy services [35]. technology in the operating room has lagged
This review estimated that medication errors behind electronic medical record innovations in
occur in about one in 20 episodes of drug admin- the hospital. Systems can print accurate labels for
istration, which is consistent with the previously syringes and also scan those syringes prior to
referenced intraoperative medication error rate medication administration. There is often verbal
[32]. Anesthesiologists, like all providers, must readout of medication as well as accurate docu-
be especially vigilant with regard to high alert mentation of administration into the electronic
medications. These are medications, which, if medical record [40]. The anesthesiologist may
administered in error, are more prone to signifi- find himself or herself giving up some of their
cant or life-threatening adverse drug events. The prior independence in order to improve patient
Institute for Safe Medication Practices publishes safety. It is prudent to carefully assess the dan-
a list of these medications and classes [36]. gers and unintended consequences of highly
Some common medications included on this list automated anesthesia systems which can create
are adrenergic agonists, adrenergic antagonists, new obstacles to delivering safe and reliable care.
anesthetics, antiarrhythmics, anticoagulants,
epidural and intrathecal medications, inotropes,
insulin, sedation agents, opioids, and neuromus- losed Claims Analysis
C
cular blockers. and Associated Anesthesia
Registries
Preventing Medication Errors The Closed Claims Analysis Project (CCAP) is a

longitudinal study of malpractice claims filed
Efforts to improve patient safety, including the against anesthesiologists in the United States. In
prevention of medication-related errors, have 1984, the ASA President, Ellison C. Pierce, Jr,
been a focus of healthcare improvement since the M.D., spearheaded a number of programs to
1999 Institute of Medicine report To err is human improve patient safety and prevent anesthetic
[37]. Optimizing care delivery in the operating injury, the most notable being the CCAP [41].
room in a way that prevents common errors is an The Closed Claims Project data includes detailed
ongoing effort. The incorporation of “smart clinical information on events and outcomes
pumps” into practice helps prevent wrong dose or allegedly causing anesthesia-related injury from
rate of drug administration [38]. However, the 1970 to the present (excluding injury to teeth),
ability to override alerts or a limited drug library regardless of whether the claim was dropped,
makes them only part of the solution. The most settled, or adjudicated [41].
common type of drug error that the anesthesiolo- By analyzing the clinical information that lead
gist is likely to encounter is that of labeling mis- to harm and malpractice legal suits, regardless if
takes [39]. Several innovations have been created the cases had been settled, dropped, or adjudi-
in an attempt to address this problem, including cated in court, the CCAP aimed to enhance
prefilled syringes with standardized packaging, patient safety by learning from each case and
concentration and pharmacy formulation to pre- assessing causes of significant anesthesia-related
vent dilution errors and wrong drug administra- poor outcomes. This project was also framed in a
tion. Additionally, distinct labeling including time when malpractice insurance premiums for
color-coding and high visibility of drug name and anesthesiologists were rising significantly. At
concentration (see Fig. 21.2) is quite common that time, anesthesiologists represented only 3 %
now and may help to reduce, but not eliminate, of insured physicians, but accounted for 11 % of
wrong medication errors [39]. the total dollars paid for patient injury.
Clinical decision support, which is widespread Despite the limitations of this method due to
in current computerized physician order entry, its retrospective nature, the inability to determine
has proved to be effective in other areas of a denominator to calculate the risk, and the fact
Fig. 21.2 Drug Label Examples. Codonics.com [Internet]. SLS Safe Label System. c2005–2016 [cited 01 Feb 2016].
Reprinted with permission from Codonics: http://www.codonics.com/Products/SLS/
that not all injured patients file claims, the project have highlighted patient safety and liability issues
was incredibly successful by providing a snapshot from the data collected by the CCAP [42]. For
of anesthesia liability [41]. From 1998 through example, closed claims findings of major sources
2010, there have been 63 newsletter articles and of anesthesia-related injury, such as death and
33 peer-reviewed manuscripts published which brain damage, have led to the creation of standards
requiring the use of pulse oximetry intraopera- implement changes with the intent of improv-
tively and the use of end-tidal carbon dioxide as ing patient outcomes.
verification of tracheal intubation by the ASA
Committee on Standards. Similarly, data on diffi- The Multicenter Perioperative Outcomes
cult intubation led to the development of the ASA Group (MPOG) and the Anesthesia Quality
Practice Guidelines for Management of the Institute began repositories of anesthetic cases
Difficult Airway in 1993. Data pertaining to fre- which can be searched by participants to examine
quent negative outcomes such as peripheral neu- rare events and outcomes, but these efforts are
ropathies and blindness associated with spine still in their infancy and are far from providing
surgery has also been captured by the CCAP and robust, broadly generalizable incidence estimates
led to the creation of practice advisories in an of the type that CCAP provides.
attempt to prevent such complications.
The CCAP and its registries are strongly
aligned with the Anesthesiology Quality Institute Checklists and Cognitive Aids
(AQI). The institute maintains different registries
with case data as the primary resource for anes- Checklists
thesiologists looking to assess and improve
patient care [43]. These registries include: One of the trickle-down, lasting patient safety
accomplishments that resulted from the publica-

(a) National Anesthesia Clinical Outcomes tion of To Err is Human: Building a Safer
Registry (NACOR): NACOR is a data ware- Health System by the Institute of Medicine is
house that is planning to capture 40 million the World Health Organization surgical safety
of the cases and several million of the pain checklist [37, 44]. Implementation of surgical
clinic procedures that are performed each checklists in hospitals throughout the United
year by anesthesiologists in the United States and world through the use of a periopera-
States. This will allow for the development tive timeout has resulted in significant reduc-
of benchmarks, where practices can compare tions in morbidity and mortality. In the inaugural
their outcomes to national data. NACOR has surgical safety checklist implementation study,
been designated by the Centers for Medicare Haynes et al. found statistically significant
and Medicaid Services (CMS) as a Qualified decreases in both the rate of death (1.5–0.8 %)
Clinical Data Registry (QCDR) for the phy- and inpatient complications (11.0–7.0 %) after
sician quality reporting system (PQRS). introduction of the checklist in eight diverse
PQRS has significant implications for reim- hospitals worldwide [44]. de Vries et al.
bursement, as those who do not report will be described similar significant reductions in
penalized starting in 2016. inhospital mortality (1.5–0.8 %) and overall
(b)
Anesthesia Incident Reporting System complications (27.3–16.7 per 100 patients) with
(AIRS): The first nationwide system for col- implementation of the Netherlands’ Surgical
lecting individual adverse events from anes- Patient Safety System [45]. Several other stud-
thesia, pain management, and perioperative ies have further supported the findings from
care. This online reporting tool can be these inaugural studies [46–48]. Notably, Semel
accessed on the AQI website. et al. found that the use of the surgical safety

(c) The Maintenance of Certification in checklist not only resulted in improvements in
Anesthesiology (MOCA®) Practice morbidity and mortality but also suggested that
Performance Assessment and Improvement it was cost-saving [49]. Utilization of the surgi-
(PPAI): As part of the American Board of cal safety checklist has also been shown to result
Anesthesiology (ABA) recertification pro- in improved operating room team communica-
cess, this tool provides a four-step process tion in addition to improved attitudes regarding
whereby diplomats assess their practices and patient safety [46, 50–53].
Despite these demonstrated improvements Cognitive Aids

in team communication, attitudes towards
patient safety, economic efficiency, and patient Recently, the use of cognitive aids to assist a team
morbidity and mortality, use of the surgical that is facing a critical event has been widely
safety checklist remains inconsistent and the endorsed. The aids make responses to such events
quality of the perioperative timeout is quite more amenable to standardization and provide
variable. In quantitative analysis of 24 video- guidance to ensure all possibilities and alterna-
recorded perioperative timeouts, Rydenfält tives are considered. Two recent reviews shed
et al. found that only 54 % of the total expected light on the use of cognitive aids. In the first, the
checklist items were completed [54]. More spe- authors discuss cognitive aids in healthcare and
cifically, they also found that team introduc- other high-risk industries, and describe why
tions, a vital component of the preoperative emergency manuals have a role in improving
timeout, were completed in only 50 % of the patient care during critical events [65].
observed timeouts. They hypothesized that Additionally, they propose four steps for the suc-
each surgical team member’s conception of risk cessful development and implementation of med-
and the perceived importance of individual ical emergency manuals: create, familiarize, use,
checklist items greatly influenced checklist and integrate. In the other review, Marshal
compliance. In a study of 671 perioperative describes mixed success with the use of an emer-
timeouts, Sparks et al. found similar problems gency manual, but suggests that cognitive aids
with checklist compliance [55]. Most notably, should continue to be developed based around
they found that the accuracy of checklist com- clinical guidelines when such guidelines exist
pletion was poor (54.1 ± 16.9 %). In a recent [66]. He also indicates that the implementation of
study by Urbach et al., implementation of a sur- these aids could benefit from extensive
gical safety checklist did not result in improve- simulation-based usability testing before clinical
ment in surgical mortality or complications due utilization. Arriaga et al. have demonstrated this
to ineffective top-down engagement and inau- technique in the development of surgical-crisis
thentic partnering and engagement with clini- checklists showing that checklist utilization
cians; however, as Leape questions, this lack of improved the management of operating room cri-
improvement could be related to poor checklist ses [67]. The advent of handheld devices and
compliance [56, 57]. It is clear that introducing apps with cognitive aids may make the use of
a checklist in an environment characterized by these tools more common and accepted.
a lack of trust causes clinicians to feel jeopar-
dized professionally and personally, and
encourages gaming of clinical metrics and mea- Patient Transitions and Handoffs
surements [58]. Effective adoption requires
local championship, sustained clinician engage- Anesthesia providers often participate in patient
ment, and a commitment to teamwork [59, 60]. handoffs several times for each patient under
Moreover, even with consistent use of the their care. The process of transferring responsi-
checklist, errors still occur, suggesting that there bility for care of a patient from one healthcare
are always underlying human factor issues at provider or healthcare team to another is referred
play [61–63]. The surgical safety checklist to as the “handoff,” or “handover,” referring to
reduces but does not eliminate the harm due to the act of transmitting information about the
human errors and their associated morbidity and patient and posed known risks and dangers to
mortality. This limitation is important to recog- patient [68]. Such handoffs occur several times a
nize as the role of checklists becomes more day between nurses, between attending physi-
prominent in the entirety of the perioperative pro- cians/nurse practitioners, and between trainees
cess, including transitions of care and periopera- when the patient is admitted to, managed in, and
tive procedures [64]. transferred from the OR to the PACU or the
intensive care unit [69]. Clinicians and research- many operating rooms and post-anesthesia care
ers agree that patient handoffs serve as the basis units continue to use paper forms or parallel elec-
for transferring responsibility and accountability tronic databases as repositories of patient infor-
for the care of patients from outgoing to incom- mation to transmit to incoming colleagues. Other
ing healthcare teams across shifts, across disci- studies demonstrate that distractions during com-
plines, and across care settings [70]. plex patient management tasks and lack of ade-
During a handoff, necessary and critical infor- quate time to complete documentation without
mation about a patient is transmitted from one care- interruptions contribute to key information being
giver to the next, or from one team of caregivers to overlooked, prioritized, or not transferred [78,
another [71]. Such information allows the health 79]. Asynchronous communication practices in
professionals or healthcare team who takes over the which the patient’s status and management plan
patient’s care to gain relevant knowledge about the are written down or audio-recorded by the outgo-
patient, understand the management plan, and ulti- ing professional and the information is ready or
mately ensure that the patient’s care continues in an played back by the incoming team later to gain
uninterrupted, error-free manner. The patient hand- information about the patient can also contribute
off between healthcare providers is a vulnerable to errors and omission of key data [80].
period in the patient’s care journey during which Patient handoff management is rarely taught
vital information may be lost, distorted, or misinter- systematically. Though, several groups have dem-
preted. Unfortunately, the practice of patient hand- onstrated success with standardized handoff sys-
off to, within and from, the OR is often suboptimal tems such as the I-PASS system [81]. In the interest
due to communication barriers and is a major con- in patient safety, it is vital that anesthesiologists
tributor to medical errors and adverse events [72]. either adopt or develop both an intraoperative and
In fact, a recent study suggested that more perioperative standardized handoff system.
operating room anesthesia handoffs are associ- The following principles can help to redress
ated with increased adverse events [73]. Further, this, and should be considered a “starter set” of
the Joint Commission and the World Health principles to be customized based on the specific
Organization have both identified patient handoff contexts of perioperative settings, teams, and
communication as a major patient safety initia- individuals as described above:
tive [74, 75].
A fundamental reason, however, is the lack of • Teach providers to tell a “better story.” More
a common ground to enable interpretation of the effective integration of the quantitative out-
complete handoff content. Common ground refers comes data with the more qualitative contex-
to the pertinent mutual knowledge, beliefs and tual data will enhance the wisdom of health
assumptions of providers that support interdepen- professionals, and capture the complexity of
dent action, and an ongoing process of tailoring, patient stories.
updating, and repairing the mutual understanding • Provide feedback. Sustain the effort by giving
and mind-sets [64]. It is constructed by three feedback about individual performance and by
skills: the ability to share, inform, and request; the setting performance expectations.
ability to jointly share attention and intentions • Couple inexperienced providers with experi-
with each other; and the ability to construct com- enced incoming and outgoing providers. The
mon cultural knowledge. According to Cohen and experienced incoming provider can demon-
colleagues, true handoffs involve a co-construc- strate proper inquiries about patient status and
tion by both parties of the oncoming caregiver’s issues, and the experienced outgoing provider
understanding of the patient, and not a one-way can demonstrate proper “storytelling” and
transmission of information [76]. methods. Capturing the wisdom of a 4–6 h
Poor information storage and retrieval sys- operation is more complex than one might
tems that are not user-friendly also contribute to assume.
compromised handoffs [77]. For example, even • Consider the use of videotaped simulated
with sophisticated electronic medical records, handovers and self-directed videotaping for
reflective learning. Use of these tools can of the other team members. However, simply
improve handover [82]. They can demonstrate bringing individuals together to perform a speci-
the nature of false assumptions and omissions; fied task does not automatically ensure that they
the effects of interruptions; good versus poor will function as a team [87]. Perioperative team-
patient problem descriptions; and the conse- work depends on a willingness of clinicians from
quences of relying only on written information. diverse backgrounds to cooperate toward a shared
• Educate all staff using interactive methods on goal, to communicate, to work together effec-
the importance of effective handoffs and about tively, and to improve. Each team member must
the characteristics of good handoff—include be able to: (1) anticipate the needs of the others;
communication training using a program such (2) adjust to each other’s actions and to the
as TeamSTEPPS or other team training pro- changing environment; (3) monitor each other’s
grams [83]. activities and distribute workload dynamically;
• Provide staff with laminated reminder cards and (4) have a shared understanding of accepted
listing desirable features of handoffs. processes, and the knowledge of how events and
• Use a mnemonic such as IPASS or SIGNOUT actions should proceed [88].
[84]. Traditionally, medical training has not
• Provide a quiet private physical space for included team-building skills, but rather, has con-
handoffs to occur. centrated on the development of individual skills,
• Develop standardized written handoff tools thus leading to the challenge of generating more
and try to import patient information automat- functional teams in the perioperative space. The
ically from the electronic medical record into airline industry, in contrast, was a pioneer in the
these tools (to avoid transcription errors) [85]. evolution of the team paradigm, moving away
from a pilot-centric approach after major airplane
disasters and transitioning to a crew resource
eams Training, Crisis Resource
T management model where emphasis is placed on
Management, and the Role communication, the use of checklists and ensur-
of Simulation ing that all members of the team are empowered
to provide their opinion [89]. Gaba recognized
In high-stakes situations, such as those in the the parallel between the cognitive profiles of
perioperative environment, success is dependent anesthesiologists and airline pilots, in addition to
on high performing and reliable teams. This dic- the similarities of the environments in which they
tum is particularly true in an environment as work [90]. Gaba and his colleagues created
complex, and at times uncertain, as the operating Anesthesia Crisis Resource Management in the
room [86]. In this site, there are additional chal- early 1990s and were one of the pioneers in
lenges as many times operating room team mem- reporting the success of this endeavor when inte-
bers change and are frequently determined almost grated with medical simulation [91, 92]. At its
randomly. Further, there are personnel changes core, crisis resource management (CRM) refers
throughout the day, and even during a single case to the nontechnical skills required for effective
due to shifts and breaks. While the operating team performance during a crisis as well as the
room personnel are well-intentioned and trained recognition and management of factors that affect
individuals who are able to work in difficult con- performance. These factors are outlined in
ditions, the evidence demonstrates these charac- Table 21.1 with further delineation of each of
teristics are insufficient, as errors and underlying these principles in Table 21.2.
system issues continue to plague the operating Assessing team competencies remains chal-
room environment leading to patient harm. lenging and there is a range of reliable methods to
Teams make fewer mistakes than do individu- assess and give feedback to surgical team mem-
als, especially when all team members know bers. Structured observation of effective team-
their individual responsibilities as well as those work in the operating room can identify
Table 21.1 Factors that affect individual and team substantive deficiencies in the system and conduct
performance
of procedures, even in otherwise successful oper-
Factor ations [93].
Individual (HALTS: • Fatigue The key principles of CRM include:
hungry, angry late, • Sleep deprivation
tired, stressed) • Emotional disturbance • Know your environment
(e.g., angry, stressed)
• Anticipate, share, and review the plan
• Ill health
• Ensure leadership, role clarity, and good
• Inexperience
teamwork
• Lack of knowledge
• Communicate effectively
Team • Role confusion
• Call for help early
• High power distance/
authority gradient • Allocate attention wisely—avoid fixation
• Ineffective communication • Distribute the workload—monitor and sup-
techniques port team members
Environment • Interruptions
• Noise Medical simulation has become ubiquitous in
• Handovers healthcare and the use of this technology in team
• Production pressure training and crisis resource management is well
• Equipment failure described and has extended beyond the walls of
• Unfamiliar place and the operating room and into all other areas of the
equipment
hospital [94, 95]. Importantly, simulation is not
Reprinted with permission from Lifeinthefastlane.com only useful for team training and CRM, but also
[Internet]. Crisis resource management: factors affecting
the performance of complex tasks. c2007–2015 [updated can be utilized for the acquisition of clinical
2014 Feb 23; cited 2016 Jan 10]. http://lifeinthefastlane. skills such as history taking and physical exams
com/ccc/crisis-resource-management-crm/ (via standardized patient actors) and technical
Table 21.2 CRM principles

Principle Actions
Know your • Know location and function of equipment, especially for time-critical procedures
environment • Logically structured and well-labeled environment
• Use cognitive aids
• Regular training
• Know the role and level of experience of team members
Anticipate, share, • Think ahead and plan for all contingencies
and review the plan • Set priorities dynamically
• Reevaluate periodically
• Anticipate delays
• Use checklists
• Share the plan with others—sharing the mental model facilitates effective action
towards a common goal
• Think out loud and provide periodic briefings to verbalize priorities, goals, and clinical
findings as they change
• Encourage team members to share relevant thoughts and plans
• Continually review the plan based on observations and response to treatment
(continued)
Principle Actions
Ensure leadership, • Employ the least confrontational approach consistent with the goal
role clarity, and good • Participative decision-making improves team buy in
teamwork • Use an authoritative approach when necessary (e.g., time-critical situations)
• Allocate team roles
• Establish behavioral and performance expectations of team members
• Establish and maintain the team’s shared mental model of what is happening and the
team’s goals
• Monitor the external and internal environments of the team to avoid being caught off
guard
• Team members should show good followership and be active—each observes and
monitors events and advocates or asserts corrective actions
• Leader provides debriefing
• Team members including the Leader need to be able to recognize when they are
affected by stress, and develop appropriate self-care behaviors
• All team members—Leaders and Followers—are equally responsible for ensuring good
patient outcomes
Communicate • Distribute needed information to team members and update the shared mental model
effectively • Use closed loop communication
• Be assertive, not aggressive or submissive
• Avoid personal attacks
• Resolve conflict
• Maintain relationships
• Facilitate collaborative efforts working towards a common goal
• Double check
Call for help early • Be aware of barriers to asking for help (e.g., fear of criticism or losing face)
• Set predefined criteria for asking for help
• Call for help early
• Mobilize all available resources
Allocate attention • Be aware of “fixation error” that reduces situational awareness
wisely—avoid • Prioritize tasks and focus on the most important task at hand
fixation • Delegate tasks to others
• Use all available information
Distribute the • Team Leader stands back whenever possible to maintain situational awareness and
workload—monitor oversee the team
and support team • Assign tasks according to the defined roles of the team
members • Team Leader supports team members in their tasks
Reprinted with permission from Miller RD. Human performance and patient safety. In: Miller’s anesthesia. 6th ed.
Oxford, United Kingdom: Elsevier; 2005. p. 121
skills (airway management, venous access, lapa- In the United States, the ABA introduced a simu-
roscopic training, etc.) with task-trainers [96]. lation experience requirement as part of its
Further, simulation allows practitioners to MOCA process. In the next several years, the
encounter and manage rare events that may never ABA will administer a “hands-on session” as part
be experienced during training or even during an of its Part 2 exam. This assessment will likely be
entire career. Malignant hyperthermia is a prime similar to an Objective Structured Clinical
example of such a rare event. Examination (OSCE), but details have not yet
Finally, many medical and anesthesia educa- been finalized.
tors have considered the use of simulation as an In sum, for practicing clinicians, simulation is
assessment tool for knowledge and skills [97, 98]. a haven for safety—both for trainees, who can
practice, make errors, and learn without harming The Anesthesia Patient Safety Foundation
anyone, and for patients, who will be cared for by (APSF) was established in the mid-1980s in
providers with superior technical and nontechni- order to organize safety campaigns, promote
cal skills. research and education regarding safety, and
serve as a national and international hub for the
exchange of information regarding patient
Perioperative Safety Organizations safety. The APSF is one of the first specialty-
specific organizations to focus on safety. It cir-
The approach toward ensuring safe care should be culates a free and easy-to-read newsletter
organized, sensible, and deliberate. Several orga- which is available on the website (http://www.
nizations have developed a vested interest in apsf.org). The APSF has helped create a cadre
ensuring safe perioperative care. The Association of experts in addition to a culture and an infra-
for Perioperative Practice (AfPP), a working group structure devoted to promoting safety. The
within the UK, defines and analyzes so- called most important feature of the APSF effort may
“never events” [1]. The National Quality Forum be the elevation of patient safety to coequal
(NQF), a nonprofit organization which aims to status with more traditional concerns, such as
improve quality in the United States, has devel- determining the molecular mechanisms of
oped a list of Serious Reportable Events (SRE) anesthesia, developing specialized drugs, or
which are defined as an “unambiguous, largely, if managing critically ill patients. An important
not entirely, preventable, serious, and any of the focus has been around the dangers of conscious
following: adverse; indicative of a problem in a sedation given growing evidence of patient
healthcare setting’s safety systems; and important harm due to inexperienced providers adminis-
for public credibility or public accountability” trating powerful sedation drugs such as propo-
[99]. The Joint Commission released the 2015 fol [103]. Designing safe and reliable sedation
National Patient Safety Goals for hospitals, includ- services for non-anesthesia providers and in
ing the goal to implement a universal protocol for nontraditional locations remains huge chal-
the prevention of wrong surgeries (wrong patient, lenge [104].
wrong site and/or wrong procedure) which con- In addition to these physician-led patient
tinue to occur despite efforts to prevent these safety organizations, the Association of periOp-
adverse events [100, 101]. In 2006, CMS in col- erative Registered Nurses (AORN) plays a vital
laboration with multiple agencies including but role in ensuring safe perioperative care. This
not limited to the Joint Commission, American organization has a mission to promote safety and
Society Anesthesiologists, American College of optimal outcomes for patients undergoing opera-
Surgeons, and the Center for Disease Control tive and other invasive procedures by providing
implemented the Surgical Care Improvement practice support and professional development
Project (SCIP). The SCIP includes multiple qual- opportunities to perioperative nurses.
ity indicators designed to improve patient out-
comes by reducing hospital-acquired infection,
perioperative myocardial infarction, perioperative Caring for the Provider
venous thromboembolism, and other perioperative
morbidity and mortality and ensure that patients A discussion of patient safety would not be com-
receive standardized care [102]. Patients and plete without mention of the central role that the
patient advocates are becoming more and more physical and emotional health of healthcare pro-
interested in seeking high quality care for them- viders plays in the safe care of patients. While a
selves and their families. CMS has published a full discussion of this topic is outside of the scope
website where patients can look at various quality of this chapter, it is important to briefly discuss
indicators (including patient satisfaction) at a several topics which are especially relevant to
regional and hospital-specific level. anesthesiology.
uman Factors and Their Impact

H adverse event [110]. While analysis of adverse
on Performance events is essential to the future prevention of sim-
ilar events, it is important to not place blame on
It is well known that sleep deprivation has significant any one individual or group, as the root causes
impacts on mood, cognitive tasks, and motor tasks are generally multifactorial or systemic in nature
[105]. Further, shifts of 24 h or more have been [111]. It is vitally important for institutions to
shown to result in impairment of psychomotor per- support providers after patients have been harmed
formance equivalent to or exceeding alcohol intoxi- and recognize at-risk personnel following adverse
cation [106]. While trainees and practicing events and provide appropriate support in an
anesthesiologists are educated regarding the effects attempt to prevent this second victim phenome-
of fatigue and sleep deprivation on patient care (both non [112, 113].
from a cognitive and motor standpoint), preventable
errors still occur that are directly attributable to these
human factors [107]. Several organizations, includ- he Future: Coordination of Care
T
ing the Joint Commission, have recommended fur- and the Perioperative
ther enforcement of work-hour limits for both Surgical Home
trainees and attending physicians [107].
Another well-known cause of impairment The ASA has proposed the Perioperative Surgical
amongst anesthesiologists and anesthesia train- Home (PSH) as a way to achieve better and sus-
ees is substance abuse. While the rates of alco- tained patient outcomes along the Institute of
holism and other types of impairment are similar Healthcare Improvement’s “Triple Aim”: enhance
to those of other professions, impairment second- quality, improve patient satisfaction, and decrease
ary to opioids is particularly problematic for cost. Under this conceptual framework, the PSH
anesthesiologists [108]. Additionally, impair- can be defined as a patient-centered and physi-
ment secondary to highly addictive drugs such as cian-led multidisciplinary system that aims to
propofol, ketamine, and nitrous oxide has been prevent variability and fragmentation of care that
described. Possible explanations for the high could result in negative outcomes from the
incidence of drug abuse amongst anesthesiolo- moment the patient is scheduled for surgery up to
gists include proximity to large quantities of 30-days after discharge [114, 115]. This proposal
highly addictive drugs, the relative ease of divert- aims to: standardize care; follow best-practice
ing particularly small quantities of these agents evidence; collect and report quality, safety, and
for personal use, the high stress environment in cost data; improve outcomes; and decrease costs.
which anesthesiologists work, and exposure in The anesthesiologist is the ideal facilitator for this
the workplace that sensitizes the reward path- coordination of care along the perioperative con-
ways in the brain and thus promotes substance tinuum, as they already provide a degree of coor-
abuse [109]. Designing better systems to monitor dination between patients, other medical staff,
providers, peer-to-peer support systems, and con- and healthcare delivery institutions. Additionally,
tinued education of providers about the dangers the specialty has a strong culture of safety and
of impairment in addition to early recognition of healthcare metrics [116]. The PSH will necessi-
impaired providers is vital to the safety of both tate an expanded scope of practice for the anesthe-
the provider and patients. siologist, not to replace the surgeon or abandon
operating room responsibilities, but rather to be a
leader in the perioperative continuum.
The Second Victim There have already been reports of successful
implementation of PSH programs, most of them
Recently, increased emphasis has been placed on aligned by service lines although robust assess-
ensuring the emotional well-being of the care ment of long-term impact are still scarce. The
team, known as the second victim, following an University of California at Irvine experience with
total joint replacements is probably the premier 3. Turner BA, Pidgeon NF. Man-made disasters.
Boston: Butterworth-Heinemann; 1997.
example [117]. Further expansion of the concept
4. Zohar D. Safety climate in industrial organizations:
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Birnbach D, Woods D, Holl JL, Bacha EA. Errors
dency educational curriculums and even increas-
and the burden of errors: attitudes, perceptions, and
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7. Edmondson A. Psychological safety and learning
included within the PSH model include: adoption behavior in work teams. Adm Sci Q. 1999;44(2):
of reliability engineering principles, technologi- 350–83.
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2003;24:7–27.
near miss reporting systems, applying critical
9. Garvin DA, Edmondson AC, Gino F. Is yours a
event analysis tools such failure mode and effects learning organization? Harv Bus Rev. 2008;
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cal mishaps: lessons from non-medical near miss
ing standardized medication, implementing
reporting systems. BMJ. 2000;320(7237):759–63.
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make it practical and sustainable.
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suc.2011.12.008.
Conclusions 13. DeRosier J, Stalhandske E, Bagian JP, Nudell T.
Using health care failure mode and effect analy-
sis™: the VA National Center for Patient Safety’s
Anesthesiologists have been and will continue to prospective risk analysis system. Jt Comm J Qual
be leaders in ensuring safe and reliable patient care. Patient Saf. 2002;28(5):248–67.
Through technological advancements in monitor- 14. Baker DP, Gustafson S, Beaubien JM, Salas E,
Barach P. Medical teamwork and patient safety: The
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evidence-based relation. Washington, DC: American
coordination of care via the perioperative surgical Institute for Research; 2003.
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Enhanced Recovery After Surgery:
ERAS 22
Jonas Nygren, Olle Ljungqvist, and Anders Thorell
“If you can't measure it you can’t manage it.”

—Peter Drucker
formed by a group of surgeons involved in

Abbreviations
research of perioperative care in Europe 15 years
ago [1]. ERAS is an approach to perioperative
CR Colorectal
care where a complex perioperative protocol
EDA Epidural anesthesia
consisting of several evidence-based interven-
ERAS Enhanced recovery after surgery
tions deployed by a multidisciplinary team inter-
GI Gastrointestinal
acts to enhance recovery after major surgical
GNP Gross national product
operations. The ERAS Study group set out to fur-
PCA Patient-controlled analgesia
ther develop perioperative care from the Fast-
PD Pancreaticoduodenectomy
Track surgery work, initially described by the
PONV Postoperative nausea and vomiting
Danish surgeon, Professor Henrik Kehlet.
QoL Quality of life
Professor Kehlet published a case series of ini-
UGI Upper gastrointestinal
tially eight patients in 1995 [2] and later a larger
cohort of patients undergoing open colonic resec-
tions, where half the patients were successfully
discharged 2 days after the operation [3]. The
Background concept used a multimodal approach to improve
recovery [4] using a bundle idea first published in
Prolonged recovery from anesthesia, including cardiac surgery. At the time (and to this day) [2],
longer hospital stay, higher morbidity, and poor this report of such a short stay after major colonic
outcomes, has plagued surgical recovery. In surgery was a sensation as the average length of
response, the ERAS—Enhanced Recovery After postoperative stay was much longer and still
Surgery—was developed as a collaboration remains more than a week in many countries
worldwide.
The ERAS group developed a perioperative
J. Nygren, MD, PhD (*) • A. Thorell, MD, PhD care pathway for colonic and rectal resections
Department of Surgery, Ersta Hospital, based on the available literature on best periopera-
Box 4622, Fjällgatan 44, Stockholm 116 91, Sweden tive care. A consensus paper was published in
2005 [5]. In the paper, 20 perioperative interven-
[email protected]
tions, most with a high level of evidence, were
O. Ljungqvist, MD, PhD
recommended as part of the ERAS pathway. Since
Department of Surgery, Faculty of Medicine and
Health, Örebro University, Örebro, Sweden perioperative care can vary also within institutions
e-mail: [email protected] with a traditional approach to perioperative care,

350 J. Nygren et al.
some of these interventions would be regarded as ERAS [12]. Similarly, the length of stay was
normal practice in parts of the world but not in oth- reduced by 2.3 days, or roughly 25 %.
ers. Some interventions were seldom adhered to In 2010, the enhanced recovery after surgery
such as balanced intravenous infusions or avoiding (ERAS®) Society for Perioperative Care (www.
preoperative fasting by providing a carbohydrate erassociety.org) was registered as a nonprofit
drink [6]. Several joint studies were performed medical society. Surgical units from a growing
over the last decade including surveys showing number of countries are currently included in a
that these practices were not being regularly used worldwide network of professionals employing
[7], and studies on how implementation of the and developing the ERAS pathway. The ERAS
ERAS protocol changed clinical practice [8]. The Society is a multi-professional and multidisci-
ERAS group formed a common database for these plinary medical society with an aim to develop
studies that later developed into an interactive perioperative care by research and education but
audit system (see below). Based on the ERAS pro- also by actively supporting hospitals worldwide
tocol, close audit and in collaboration with the to implement ERAS principles. An important
CBO Kwaliteitsinstituut in the Netherlands, a part of this program involves helping the units to
series of implementation programs were run with get full control over their practice by employing
great success. In the Dutch ERAS implementation an interactive audit tool developed based on the
study, more than 30 hospitals moved from an aver- ERAS Society guidelines [13–18]. To date, there
age compliance with the ideal ERAS protocol of are about 30 surgical centers from 16 countries
44–75 % adherence [9]. This change of practice that are leading the development of the ERAS
was associated with a significant reduction in practice. The ERAS Society has so far held three
recovery time in postoperative length of stay from annual world congresses on ERAS. In some
around 9–10 days to 6–7 days. The basis for this countries, national Societies were formed early
program was not only the ERAS recommenda- such as the ERAS UK, Fast-Track Surgery group
tions but also active coaching of the units using in Spain, ERAS Canada, and ASER in the
new methodology [9]. Another key component USA. Many of these national groups have run
was the multidisciplinary team approach involving events jointly with the ERAS Society.
surgeons, anesthetists, nurses, and also physiother- Part of the success of ERAS relates to the grow-
apists and dietitians. These initial efforts formed ing evidence of not only major improvements in
the basis of the ERAS Implementation Program outcomes for the patients, but also marked savings
run by the ERAS Society (see “Implementation” for the health provider and funders of health care.
section). This is particularly timely given the fast growing
The English National Health Service decided and unsustainable increase in health care costs
to support implementation of Enhanced Recovery worldwide. Several reports in the last few years
in colorectal, orthopedic, gynecologic, and uro- indicate major savings when employing the prin-
logic major elective surgical practice during ciples of ERAS [19]. This is mainly related to less
2009–2012 [10]. An audit conducted after this need for intensive care, reduced complications,
large-scale program of more than 24,000 patients reduced costs for pharmacotherapy and parenteral
demonstrated that improved compliance with the nutrition, and the reduced need for hospital beds
ERAS pathway was associated with reduced [19]. A main mechanism behind the functionality
length of stay in colorectal, orthopedic, urologic of ERAS is the stress reducing effect of the proto-
but not in gynecological surgery [10]. col elements [20]. Many of the ERAS protocols
A 2010 meta-analysis demonstrated reduced dampen the classical stress reaction with stress
length of stay and reduced postoperative compli- hormone release and inflammatory responses
cations in ERAS vs. traditional care [11]. A more thereby reducing the catabolic reactions and insu-
recent meta-analysis showed a reduction in com- lin resistance, otherwise developing as a response
plications of around 40 %, mainly in medical to surgery [21]. By combining several of these ele-
complications in colorectal surgery when using ments using a multimodal approach, the ERAS
22 Enhanced Recovery After Surgery: ERAS 351
Fig. 22.1 Interventions involved in multimodal ERAS protocol in open colorectal surgery. Adopted from Fearon et al.
(2005) [5]
protocol may effectively minimize the stress jects with substantial comorbidity. Thus, in order
response (Fig. 22.1). This maintained homeostasis to reduce risk and to improve clinical outcome in
for metabolism and fluid balance support return of this group of patients, a thorough preoperative
organ function and thus complications are avoided. preparation and optimization is necessary. This
The ERAS protocol has been shown to effectively includes a detailed assessment of comorbidity
reduce complications, as well as symptoms that and multidisciplinary involvement in the optimal
keep the patient in the hospital, such as pain and/or treatment of hypertension, cardiac and respira-
nausea [22]. tory function [20, 23]. Glucose control should be
evaluated using fasting blood glucose or HbA1C
levels [20, 23]. Also in nondiabetic individuals,
The ERAS Protocol: Individual Items an increased or borderline-increased HcA1C was
associated with a threefold increase in postopera-
Items are summarized in Table 22.1. tive complications after colorectal surgery [24].
In case of anemia, the need of iron supplementa-
tion should be considered. Malnourished patients
Preoperative Optimization have a high risk of postoperative complications
and benefit from preoperative nutritional sup-
Advances in surgical and anesthesiological care port, which in most patients is tolerated using
have allowed major surgery to increasingly be the oral route [15]. There is evidence that phar-
offered to the ageing population as well as in sub- maconutrition/immunonutrition (supplements
Table 22.1 Interventions included in ERAS protocol in sooner after surgical stress [20]. A systematic
GI surgery
review evaluated the effects of preoperative exer-
Preoperative Preoperative optimization cise therapy on postoperative complications and
Prehabilitation and exercise length of stay in surgery of all types [26]. In
Cessation of smoking and patients undergoing cardiac, orthopedic, and
alcohol use
abdominal surgery, a meta-analysis indicated that
Preadmission counseling
prehabilitation led to a reduced length of stay and
Intraoperative No oral bowel preparation
improved physical fitness. Although the applica-
Preoperative carbohydrate
loading bility of these studies to patients undergoing spe-
Antimicrobial prophylaxis and cific colorectal or upper GI surgery procedures is
skin preparation unclear, they may be a promising concept.
Avoiding sedative premedication
Balanced fluid therapy
Active warming Smoking and Alcohol Cessation
Minimally invasive surgery
No abdominal drains or Tobacco smoking is associated with an increased
nasogastric drains risk of postoperative morbidity and mortality,
Postoperative Epidural or other regional attributed mainly to reduced tissue oxygenation
anesthesia
(and consequent wound infections), pulmonary
Multimodal analgesia to avoid
opioids complications, and thromboembolism. A recent
PONV prophylaxis Cochrane review concluded that cessation of
Early removal of urinary catheter smoking, preferably at least for 4–8 weeks before
Thromboembolism and surgery, was associated with marked reductions in
antimicrobial prophylaxis postoperative complications (Intensive care unit
Early oral feeding and intense intervention, effects on any postoperative compli-
mobilization cation: RR 0.42; 95 % CI 0.27–0.65) [27]. In addi-
Nutritional supplements tion, hazardous drinking, defined as intake of
No intravenous infusions three alcohol equivalents (12 g ethanol each) or
Support of GI function more per day, has long been identified as a risk
(laxatives/prokinetics)
factor for postoperative complications. Alcohol
Audit
abstinence for 1 month has been associated with
PONV postoperative nausea and vomiting, GI
gastrointestinal
better outcome after colorectal surgery [28].
Available ERAS guidelines for colorectal and
upper GI surgery, therefore, recommend cessation
containing specific nutrients such as arginine, of alcohol for abusers and tobacco use in all
glutamine, Ω-3 fatty acids, and others) may patients 4 weeks prior to surgery. In bariatric and
reduce postoperative infection rates and hospital other benign major abdominal surgery, even lon-
stay in patients undergoing major abdominal surger periods of alcohol abstinence are usually rec-
gery [25]. This intervention may be considered in ommended in patients with history of alcohol
subjects undergoing procedures associated with a abuse.
high risk of postoperative infection regardless of
preoperative nutritional status.
reoperative Information, Education,
P
and Counseling
Prehabilitation and Exercise
Preoperative information and/or a visit to the sur-
Prehabilitation comprises preoperative physical gical ward have been shown to reduce anxiety,
conditioning to improve functional and physiolog- and improve compliance with postoperative
ical capacity in order to enable patients to recover instructions, postoperative recovery, length of
stay, and long-term outcomes after various types orally or intravenously at least 30 min before skin
of surgery [15]. Although data from studies spe- incision [15]. Repeated dosing can be adminis-
cifically evaluating the effect in specific proce- tered depending on the half-life of the drug and
dures such as in upper gastrointestinal surgery the duration of surgery. The skin should be pre-
are sparse, preoperative counseling is part of cur- pared with chlorhexidine–alcohol [15].
rently published ERAS guidelines.
Preanesthetic Medication
Intraoperative Care and Anesthetic Management
Mechanical bowel preparation before colorectal There is no convincing evidence in the literature of
surgery has been extensively evaluated, and gen- the benefits from long-acting sedatives prior to
erally abandoned since it provides no benefit surgery and their use is therefore not recom-
[15]. In patients with a planned diverting loop mended. Short-acting anxiolytics might be used,
ileostomy after low anterior resection, mechani- in particular to facilitate procedures such as inser-
cal bowel preparation is still recommended to tion of epidural catheters. The data from studies
avoid remaining stools in a diverted colon [25]. comparing various anesthetic protocols is sparse.
However, the use of short-acting induction agents
such as propofol and opioids such as sufentanil is
Preoperative Fasting usually recommended and included in available
and Preoperative Treatment ERAS anesthesiological [20], colorectal [15], and
with Carbohydrates upper GI guidelines [20]. In addition, short-acting
muscle relaxants are widely used. In particular in
Fasting from midnight before elective surgery is laparoscopic surgery, deep neuromuscular block is
not supported by evidence, and therefore, in most helpful in order to ensure surgical access. In order
guidelines has been replaced with guidance for to avoid deep sedation, a Bispectral Index (BIS)
fluid intake of clear fluids up to 2 h prior to induc- might be used for titration of anesthetic agents
tion of anesthesia [29]. Solids should, however, although the evidence for its efficacy is limited.
be withheld until 6 h before operation to prevent
risk of aspiration. A preoperative carbohydrate-
rich drink given up to 2 h before anesthesia has Perioperative Fluid Balance
been shown to reduce preoperative hunger, thirst,
and anxiety [30]. In addition, PONV [31] and Near-zero fluid balance, avoiding salt and water
surgical stress as measured by postoperative overload, has been shown to result in improved
insulin resistance and protein catabolism are outcomes [20, 23]. Vasopressors should be con-
improved and length of stay is reduced, with the sidered as first choice to treat hypotension to
most pronounced effect after major surgery [6]. avoid unnecessary fluid overload. Goal-directed
Avoiding preoperative fasting using carbohydrate fluid therapy is recommended to obtain optimal
loading is therefore recommended in current tissue perfusion and in high-risk patients Doppler-
ERAS guidelines for colorectal surgery, gastrec- guided techniques might be used in order to
tomy, pancreaticoduodenectomy [14–16], and improve outcome [32], even though the benefits
bariatric surgery [13]. are unclear in patients already managed within an
ERAS pathway.
ntimicrobial Prophylaxis and Skin

A
Preparation Avoiding Hypothermia
Prophylactic antibiotics reduce infectious com- There is convincing documentation of benefits

plications. Patients should receive a single dose associated with prevention of hypothermia in
terms of reducing complications as well as improv- asogastric Tube and Abdominal

N
ing postanesthetic recovery [33]. This is usually Drains
achieved by the use of active cutaneous airborne
heating systems (Bair-hugger) or circulating-water A Cochrane meta-analysis concluded that routine
garments. Avoidance of hypothermia is of particu- nasogastric intubation following open abdominal
lar importance in surgical procedures with long surgery should be abandoned in favor of selective
operating times such as pelvic procedures or pan- use [39]. A subgroup analysis of nine RCTs with
creaticoduodenectomy, whereas the effects might 1085 patients that underwent gastroduodenal sur-
be less pronounced in, for example, uncompli- gery found increased pulmonary complications
cated laparoscopic bariatric surgery [34]. associated with routine use of postoperative naso-
gastric tube. In addition, intra-abdominal or pel-
vic drains have no advantage in colorectal surgery
Access [15] although the evidence in pelvic procedures
was based on a small number of patients. However,
Minimally invasive surgery reduced damage to a large multicenter RCT of prophylactic pelvic
tissues by changes in surgical access [20]. In drains in low anterior resection (GRECCAR 5,
open surgery, the length and orientation of inci- ClinicalTrials.gov Identifier: NCT01269567) was
sion affect pain and may influence surgical out- recently completed and preliminary data
comes [20]. The extent of the injury to abdominal (Presented by Dr. Denost at ESCP in Dublin, at
wall is further reduced using minimally invasive International Trials Symposium, September 23rd,
techniques such as laparoscopy which has been 2015) show no effect of pelvic drains on the inci-
evaluated for the treatment of colorectal cancer in dence or severity of anastomotic leakage. Peri-
randomized trials [35, 36]. The safety and overall anastomotic drains have not been shown to reduce
value of robotic surgery remains unclear although overall complication rates in pancreatic [40] or
present evidence suggests higher costs and at gastric cancer surgery [41], and are associated
least similar rates of complications [37]. We are with slower recovery [42]. Similarly, no advan-
awaiting results from a large multicenter (RCT: tages were shown by the use of abdominal drain
ROLARR, ClinicalTrials.gov. Identifier: after gastric bypass for morbid obesity. Thus, no
NCT01736072). Other minimally invasive convincing evidence supports the routine use of
options such as Trans-anal TME, SILS, or postoperative drains after upper gastrointestinal
NOTES are still under evaluation. surgery. In contrast, the use of a passive subcuta-
In bariatric surgery, laparoscopy has rapidly neous drain was associated with a reduction in
superseded open surgery due to improved out- superficial surgical site infections in a randomized
come in terms of reduced complications and study of 263 patients undergoing open or laparo-
improved recovery [38]. For distal gastrectomy, scopic colorectal surgery [43].
there is evidence supporting the use of
laparoscopic-assisted surgery in early gastric can-
cer, whereas more data on long-term survival after Urinary Catheter
laparoscopic compared to open surgery in
advanced disease is still awaited [14]. In total gas- The duration of urinary drainage should be as short
trectomy, laparoscopic-assisted approach might be as possible, and the catheter can in most cases be
used if expertise is available, since it has been removed within 24 h after colorectal surgery with-
shown to reduce complication rates and improve out increased incidence of urinary retention [15].
patient recovery [14]. Although laparoscopic Early removal with intermittent urine drainage as
resection of the pancreatic head has been shown to needed has been shown to be safe also in patients
be feasible, too little data is available on oncologi- with thoracic epidural analgesia [15]. When uri-
cal outcomes after laparoscopic pancreaticoduo- nary catheterization of more than 3 days postopera-
denectomy to recommend its routine use. tively is expected (i.e., some pelvic procedures), a
suprapubic catheter seems the better choice [15]. patients at risk of PONV should be treated with a
The optimal duration of ureteral stents and trans- multimodal approach with the use of antiemetics
urethral neo-bladder catheter after radical cystec- according to patient risk factors [20, 23]. This
tomy is still unknown [18]. includes the use of propofol for induction of
anesthesia and avoidance of volatile anesthetics,
opioids, and fluid overload. The recommended
Postoperative Care antiemetics for PONV prophylaxis vary in their
efficacy and include 5-hydroxytryptamine recep-
Postoperative Analgesia tor antagonists, corticosteroids, butyrophenones,
neurokinin-1 receptor antagonists, antihista-
Comprehensive ERAS guidelines for anesthesia mines, and anticholinergics [44].
practice in gastrointestinal surgery have recently
been published [20]. In open abdominal surgery,
epidural analgesia (EDA) has been shown to pro- Antithrombotic Prophylaxis
vide superior postoperative pain control com-
pared with opioids as well as patient-controlled The risk factors for venous thromboembolism
intravenous opioid analgesia (PCA). Moreover, (VTE) include major surgery, malignant disease,
the EDA was reported to be associated with fewer and obesity. Therefore, patients undergoing
episodes of postoperative ileus, pulmonary com- major colorectal and upper GI surgery are at risk.
plications, and improved insulin sensitivity. A Low molecular weight heparin (LMWH) is effec-
thoracic EDA is recommended in ERAS guide- tive at preventing VTE and advantageous com-
lines for open colorectal and major upper GI sur- pared to unfractionated heparin due to its
gery such as pancreaticoduodenectomy and once-daily administration. Mechanical methods
gastrectomy. Studies evaluating the use of EDA in such as intermittent pneumatic compression or
open liver resections are sparse. The EDA in lapa- graduated compression stockings may be used as
roscopic colorectal procedures where skin inci- an adjunct in patients who are at moderate or
sion and abdominal wall injury is kept minimal high risk for VTE. LMWH treatment is usually
has been questioned. In addition, there is no con- initiated either the evening before, or within 6 h
sensus regarding the value of EDA in laparoscopic postoperatively and continued at least until
upper abdominal surgery, such as gastric bypass. patients are fully mobile. After major open
In situations where an EDA cannot be used, a surgical procedures 4 weeks treatment is usually
PCA is the most commonly used alternative after recommended, whereas 7 days is usually consid-
open abdominal surgery although other alterna- ered sufficient after laparoscopic surgery. The
tives, including various techniques for regional risk of spinal or epidural hematoma in patients
anesthesia and intravenous lidocaine infusion, are with EDA should be considered and a 12 h inter-
recommended in ERAS guidelines [20, 23]. After val between LMWH administration and catheter
cessation of EDA or PCA, multimodal systemic insertion or removal should be adhered to.
analgesia should be used including non-opioid
analgesics such as paracetamol and NSAIDs. For
opioids, when necessary, the enteral routes should Early and Scheduled Mobilization
be used as soon as possible.
Major open abdominal surgery is associated
with long recovery time even in the absence of
ostoperative Nausea and Vomiting
P complications. Prolonged immobilization/bed
(PONV) rest is associated with several adverse effects
and should be avoided although scientific data is
Although mainly extrapolated from studies in lacking [20, 23]. Day-to-day targets for mobili-
colorectal surgery, available data suggest that zation should be defined and progress monitored
and documented. Satisfactory pain control is ERAS program. Using the International ERAS
mandatory in order to achieve adequate mobili- database facilitates this process through a detailed
zation. In patients undergoing laparoscopic sur- registration on the perioperative care, and the clini-
gery, early mobilization is normally much easier cal outcome of the patients in combination with a
to achieve, and usually possible within a few clique view statistical ad on that provides an easy
hours after surgery [20, 23]. and immediate feedback and analysis of registered
data (http://www.erassociety.org/).
arly Oral Intake and Stimulation

E
of Bowel Movement I mplementation of an ERAS
Program
Early oral intake has been shown to be safe and
most often feasible after major colorectal as well Given the growing evidence of improved outcomes
as upper gastrointestinal surgery [20, 23] and using the ERAS protocol, it would seem likely that
should therefore be encouraged. However, in the these principles would be adopted without delay.
presence of impaired gut function, enteral or par- However, implementation of ERAS involves over-
enteral nutritional support might be necessary, in coming many barriers to change in care including
particular if complications occur. Return to oral many routines that may have been in use for a very
intake should be aimed for as soon as possible. long time [46]. Many units like to believe that they
The need for motility-enhancing drugs is usually already practice ERAS while in fact a careful study
not required after upper GI surgery compared with of their actual perioperative practice might reveal
after colorectal surgery. Although commonly used that only some elements of the ERAS protocol are
after colorectal surgery, only some fast-track pro- in use and that clinical outcomes are on a level
grams for pancreatic surgery include the use of similar to what is found in traditional care. This
laxatives postoperatively, and there is limited doc- may also be reflected after review of the average
umentation of the effectiveness of such regimens hospital length of stay data. In the UK and Sweden,
after gastrectomy and hepatic surgery. where most surgical units would claim that they are
using ERAS, postoperative stay after resections for
colonic cancer is currently averaging eight days (as
Discharge shown in the national colorectal cancer registries).
In France, these figures are similar or even higher.
Patients can generally be discharged when they Since minimally invasive techniques are gaining
tolerate adequate oral intake, when they are fully momentum, recovery should be earlier also in tra-
mobilized and when pain can be managed with ditional practice. In contrast to these national fig-
oral analgesics. Sufficient time should be pro- ures, surgical units using a more complete ERAS
vided for the patient to independently manage a protocol report postoperative length of stay of
new stoma. After early discharge, patients should around 3–4 days after colonic resections with mini-
be contacted by a nurse after 2–3 days, to assure mal invasive surgery, and as short as 2–3 days in
that rehabilitation is progressing well. Usually the most advanced units [47].
another contact 30 days postoperatively is useful It is often stated that medical practice is very
in order to assure a normal postoperative course slow to change and it may take 15 years for a fully
and to prevent hospital readmissions [45]. established proven novel care to get in full use.
Surgery and anesthesiology are no exceptions to
this [7, 48] rule due to barriers to behavior change
Audit and adoption of new concepts [49]. A very well-
known example is the use of overnight fasting as a
A structured audit on perioperative care and clinical way of protecting patients from aspiration. This
outcome is essential for maintaining a successful routine was introduced in the early days of surgery
and has no scientific backing. When the routine The ERAS Society Implementation Program
was challenged in the 1980s and 1990s, numerous is performed as a series of four workshops over a
studies demonstrated clearly that patients could be period of 8–10 months involving several teams
allowed to drink clear fluids up to 2 h before elec- for each implementation program. In between the
tive surgery [29]. In fact, gastric volumes were workshops the participants make the changes
lower since intake of clear drinks stimulates gas- needed in their practice to improve adherence to
tric emptying. Anesthesia guidelines in the last 20 the ERAS protocol. This requires careful plan-
years have advocated the novel routine of 6 h fast- ning from the team under guidance and coaching
ing after intake of solids and 2 h for clear fluids from ERAS experts with experience in both the
[29]. Nevertheless overnight fasting is still in use ERAS concepts and implementation issues [54].
in many hospitals worldwide. Similarly, some sur- The coaching needs to be individualized to meet
geons still use postoperative drains and nasogas- the specific needs at hand. The ERAS Society has
tric tubes despite grade A evidence that these are developed a web-based IT system for continuous
not useful as prophylactic measures after colorec- Interactive Audit. All ERAS teams use the same
tal surgery [50]. system and record data on all their consecutive
Similar to what have previously been raised patients into the system. The teams can easily
about surgical checklists, Rapid Response teams, review details of their practice, review changes
CLABSI, and more, the methodological chal- over time, and make changes in practice
lenges of evaluating complex social interventions accordingly.
such as the ERAS program are presently been
managed within the ERAS community (http://
www.erassociety.org/). In planning future surgi- Economics of ERAS
cal care, more advanced collaboration between
care providers, medical academia, and clinical Health care is under growing financial and politi-
institutions will provide further optimization on cal pressure worldwide. In some countries, the
perioperative care and a more complete apprecia- cost for health care has risen to 18 % of the GNP
tion of the organizational culture [51] and evalu- and in most countries they are rising [55].
ation of implementation interventions and their Obviously this is not sustainable, and major
outcomes after major surgery [52]. changes to control staggering costs are taking
Although there are currently many units that place, not least in the USA. The demand on
have implemented ERAS, many hospitals are health care is also rising from a growing elderly
still practicing perioperative care in a more tradi- population and increasing demands for better
tional fashion [7, 48]. The ERAS Society has results. So the challenge facing health care pro-
developed a protocol to introduce and fully viders today is to provide better care for an older
implement ERAS. An ERAS Implementation population at a lower cost.
Program may be organized by a national center Several reports demonstrate major cost reduc-
following a careful identification of the imple- tions when employing ERAS [56]. Most of these
mentation strategies [52]. For each hospital a studies have used calculations from ERAS in
multidisciplinary team is gathered and trained to colorectal surgery, but other surgical procedures
work as an ERAS team using robust scientifically such as esophageal resection, liver and pancreas
validated team training methods [53]. The team is surgery, as well as major gynecology are showing
often supervised by a physician, usually a sur- the same trends of substantial savings. In general,
geon or anesthetist, but the ERAS coordinating the savings are in the range of 1500–4500 USD
nurse is also a key person in this team. The ERAS depending on where the study is done and how the
nurse coordinates the group activities and the calculations were made [57]. Most commonly the
continuous audit. The team should have support savings are calculated on the basis of reduction in
from management to get the required resources hospital days or reduced need for ICU stay and
for successful implementation of ERAS. sometimes reoperations and readmissions. Data
from a detailed analysis is available from a group be cured from his/her disease and to recover suffi-
in Switzerland [58] where all costs were calcu- ciently to be able to return home. Thereafter the
lated including the cost of changing from open to focus shifts to being able to go back to normal
laparoscopic surgery, the cost for the ERAS team, function and activity. While it may seem likely
the training, etc. This analysis showed that it took that, if early recovery is improved, recovery in the
20 patients to cover the cost associated with long term would be improved as well, there is no
implementation of the ERAS program. In the first data to confirm this hypothesis. Patient-centered
50 patients the savings were approximately outcomes [63], such as the Patient Quality
USD2000 per patient. The variation in savings is Recovery System, which is available for research
usually dependent on the effect of the implemen- online (www.pqrsonline.org), may provide valu-
tation with regard to length of stay and complica- able information on such outcomes. However,
tions. Thus, pancreatic surgery has been reported these studies still need to be done.
to be more cost-effective with ERAS than gyne- There is also a growing interest in long-term
cologic surgery. Still, surgery of any magnitude is outcomes after ERAS. Reports from large data-
likely to show cost-effectiveness [59–61]. bases in the USA show an association between a
complication occurring after surgery and long-term
morbidity [64]. Patients with a complication have a
esearch Outcomes and Quality
R much lower life expectancy than patients without
of Life complications. This difference remains in patients
surviving the first 30 days postoperatively, and the
The overwhelming majority of studies in ERAS survival curves continue to diverge during a follow-
have focused on short-term outcomes such as up of 10 years after the operation. There is also a
length of stay and complications. However, only a growing interest in the effects of perioperative
few studies have reported data on outcomes treatment on long-term cancer survival rates.
beyond 30 days including quality of life beyond 30 There are only a couple of reports showing
days. These data are urgently needed to help associations between the ERAS protocol and
improve quality of care, public reporting and improved long-term survival. With the introduc-
increased value of surgical care [62]. With the tion of ERAS protocols in hip and knee replace-
proven effects of ERAS in the short term, there is ment, the 2-year survival had improved in 1500
a growing interest in the potential long-term effects consecutive patients compared to 3000 controls
(Summary of research issues related to ERAS in before the introduction of ERAS [65]. In a cohort
Table 22.2). The primary goal for the patient is to of more than 900 patients undergoing colorectal
cancer surgery under the ERAS pathway, a higher
compliance with the ERAS protocol was associ-
Table 22.2 Research issues related to ERAS
ated with improved 5-year overall and cancer-
Short term Recovery specific survival [66]. Although these studies
Hospital stay may not show cause and effect, they raise impor-
Clinical outcomes tant questions about causality and long-term ben-
Cost-effectiveness efits of ERAS.
Medium term QoL
Postdischarge recovery
Need for assistance at home
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The Next Frontier: Ambulatory
and Outpatient Surgical Safety 23
and Quality
Beverly A. Kirchner
“Knowledge and error flow from the same mental sources, only success can tell the one
from the other.”
—Mach, 1905, p. 84
providing care. Therefore, in 2006, healthcare

Introduction and Overview leaders from the ambulatory industry and asso-
ciations with a focus on healthcare quality and
The Centers for Medicare and Medicaid Services safety formed the ASC Quality Collaboration
(“CMS”) defines the Ambulatory Surgical Center (“ASC QC”). The ASC QC has worked closely
(“ASC”) in the Conditions for Coverage that can with the National Quality Forum (“NQF”) to
be found on their website www.cms.gov. The obtain endorsement of quality indicators that are
CMS defines an ASC as “any distinct entity that significant to ASCs. The ASC QC has recently
operates exclusively for the purpose of providing expanded to work with other organizations to
surgical services to patients not requiring hospi- continue assisting in the development of quality
talization and in which the expected duration of indicators for specialties such Gastrointestinal,
services would not exceed 24 h following an Ophthalmic, Pain Management, Orthopedics,
admission. The entity must have an agreement and Anesthesia. To date, CMS has adopted many
with CMS to participate in Medicare as an ASC, of the quality indicators the ASC QC has helped
and must meet the conditions set forth in subparts to develop and ASCs are required to report
B §§ 416.25–416.35 and C §§ 416.40–416.52 of results of the quality indicators if the ASC per-
[42 CFR Part 416 of the CMS Federal Register]” forms 249 or more Medicare cases annually. The
[1]. Note the key phrase in the CMS definition measures developed by the ASC QC include
“distinct entity that operates exclusively for the both outcome and process measures. An “outcome
purpose of providing surgical services” [1, 3]. measure” assesses patients for a specific result
ASCs are highly regulated healthcare facilities of healthcare intervention. A “process measure”
that are focused on the quadruple aim: improv- evaluates a particular aspect of the care that is
ing the patient experience of care (including delivered to the patient” [2].
quality and satisfaction), improving the health of The ASC QC has helped develop the following
populations, reducing the per capita cost of seven outcome measures:
healthcare and improving the experience of
1 . Patient fall in the ASC.
2. Patient burn.
3. Hospital transfer/admission.
B.A. Kirchner, BSN (*) 4. Wrong: site, side, patient, procedure, implant.
SurgeryDirect LLC, 723 County Glen Court,
Highland Village, TX 75077, USA
5. All cause hospital transfer/admission.
e-mail: [email protected] 6. Normothermia.

364 B.A. Kirchner
7. Toxic anterior segment syndrome (“TASS”; a Table 23.1 Measures ASCs are required to report in
ASC Quality Reporting (ASCQR)
rare and devastating complication of intraocu-
lar surgery) [2]. ASC-01 Patient burn
ASC-02 Patient fall
The ASC QC has also helped develop the fol- ASC-03 Wrong site, wrong side, wrong patient,
wrong procedure, wrong implant
lowing two infection control process measures:
ASC-04 Hospital transfer/admission
ASC-05 Prophylactic IV antibiotic timing
1 . Appropriate surgical site hair removal. ASC-06 Safe site surgery checklist use
2. Prophylactic intravenous (“IV”) antibiotic
ASC-07 ASC facility volume data on selected ASC
timing [3]. surgical procedures
ASC-08 Influenza vaccination coverage among
The ASC QC does a great job of keeping its healthcare personnel
website, ascquality.org, current and can be used ASC-09 Endoscopy/polyp surveillance: appropriate
follow-up interval for normal colonoscopy
as a resource for ASCs wishing to perform exter-
in average risk patients
nal benchmarking. The ASC QC also provides ASC-10 Endoscopy/polyp surveillance:
guides and other resources to help ASCs success- colonoscopy interval with a patient with a
fully accomplish the task of tracking and report- history of adenomatous polyps—
ing the quality indicators. avoidance of inappropriate use
The ASC Quality Reporting program ASC-11 [Voluntary reporting] cataracts—
improvement of patient’s visual function
(“ASCQR”) was developed to enact safety mea- within 90 days following cataract surgery
sures that assessed patient outcomes. In the ASC-12 Facility 7-day risk standardized hospital
ASCQR, the ASC is required to report all data visit rate after outpatient colonoscopy [21]
collected. Failure to report data results in a reduc-
tion of the ASC’s Medicare payment amount.
Currently, ASCs are required to track and that has failed. The goal of the QAPI program is
report on 12 measures (see Table 23.1). Each to be able to identify potential process issues
ASC must track and then compare and report the before they actually have caused patient harm.
results to their Governing Board and CMS While it is generally accepted that most ASCs are
through Claimed Base Reporting, Quality Net, excellent at collecting data, the real change hap-
and the National Healthcare Safety Network pens when the ASC begins using the data col-
(“NHSN”). The ASC leadership team must lected to improve processes and decisions.
ensure that the staff member(s) managing the Therefore, the key to a successful QAPI program
Quality Assessment Performance Improvement is knowing how to use the data collected and
program (“QAPI”) receives specialized educa- implementing the correct changes.
tion annually and is given appropriate time and
space to work to accomplish the requirements.
ASCs must be proactive in developing a com- actors That Drive a Culture
F
prehensive, ongoing QAPI program. The proof Safety in an ASC
gram must be data driven and show that the ASC
is improving quality of care and providing a safe Building a culture of safety in an ASC is a team
environment for the patient, visitors, and staff. effort. The ASC is an environment where the staff
The quality improvement program evaluates the members, physicians, guests, and vendors must
processes in which tasks are carried out and iden- all work together to provide safe, quality care for
tifies the potential for future process failures. the patient. The ASC leadership team, overseen
Every member of the staff should be educated on by the Administrator, runs the day-to-day opera-
how to identify a potential process failure and tions. The Administrator is granted the authority
report the problem. In addition, all staff members by the Governing Board to oversee day-to-day
need to be educated on how to evaluate a process operations and make decisions that impact quality
for a potential failure or how to evaluate a process and safety. CMS states that, “The ASC must have
23 The Next Frontier: Ambulatory and Outpatient Surgical Safety and Quality 365
a governing body that assumes full legal responsi- enforce the ASC’s goals addressing patient
bility for determining, implementing, and safety. Team members feel they are valued and
monitoring policies governing the ASC’s total respected when they speak up. Team members
operation.” The governing body has oversight and actively encourage patients and family mem-
accountability for the quality assessment and per- bers to participant in patient care [6].
formance improvement program, ensures that the • The ASC is transparent and discloses to the
facility policies and programs are administered so patient and family what error(s) was made and
as to provide quality healthcare in a safe environ- the potential consequences of the error.
ment, and develops and maintains a disaster pre- Embracing transparency is woven into the
paredness plan” [4]. ethical and moral responsibility of the ASC
Culture begins at the top and filters down to organization. The ASC leadership team com-
every employee, surgeon, and anesthesia pro- municates to the Governing Board errors and
vider working in the ASC. Lucian L. Leape, MD other safety problems. The Governing Board
says, “Management must ‘manage’ for patient provides support to the team to resolve the
safety just as they manage for efficiency and problem and provides resources to prevent
profit maximization. Safety must become part of further errors.
what a hospital or healthcare organization prides • The organization promotes a blame-free
itself on” [5]. The mission of every ASC should environment.
be to encourage the sharing of knowledge freely;
thus optimizing patient safety practices. The staff Typical characteristics found in a blame-free
members must be empowered by leadership to environment:
speak up and support patient safety.
Typical characteristics found in ASCs that • The organization embraces the concept that
embrace a safety culture: most errors occur as a result of flawed systems
or processes, not flawed people.
• The team embraces patient safety goals and • The ASC rewards the team for reporting of
processes. They understand how to implement errors, near misses, and safety concerns.
process and procedural changes that support • The organization educates and reeducates
the delivery of patient care [6]. its staff every time a process change is
• The ASC team establishes a patient safety made.
program that is well defined and supports • Prevention of errors is one of the ASC’s key
communication. Communication should be focus points.
clear and convey a strong commitment to
safety. The ASC safety programs have well- Typical characteristics found in an ASC that
defined objectives. The ASC should have at focuses on safety:
least one person dedicated to collecting and
analyzing safety data. The data and sug- • The ASC is proactive in looking for ways to
gested changes are reported through the improve safety in every process used in the
QAPI Committee to the Medical Executive center.
Committee to the Governing Board. The • The ASC incorporates checklists, protocols,
Governing Board must see and understand and defined work processes.
that the Quality and Safety program are • The ASC embraces the process of “hand[ing]-
essential to patient care. The Governing off” a patient from one caregiver to the next
Board must provide the resources needed to caregiver using a specialized handoff
maintain the program [6]. checklist.
• The ASC team willingly discusses patient • The team encourages the patient to participate
safety. Team members seek out the means to in the handoff by encouraging the patient to
assure communication is appropriate and “speak up” if something said is not accurate.
366 B.A. Kirchner
Resolving conflict among caregivers is imper- ASCs to follow the process by allowing organiza-
ative to the culture of safety. If staff members are tions to keep the information confidential. Some
not trained to deal with conflict, then the environ- healthcare leaders feel that if the QAPI process is
ment has the potential to become toxic with char- not held confidential, many healthcare facilities
acteristics such as bullying, gossiping, and would not fully investigate or report problems.
sabotage becoming the norm. An ASC can be a Without the investigation and reporting of prob-
high-stress area to work. The fast pace of work lems, the ambulatory industry would be setup to
performed in an ASC creates an environment ripe make the same errors over and over again with
for potential conflict. The staff needs to be taught the potential to harm patients. However, most
how to deal with high-stress levels and to com- facilities are afraid to share errors and lessons
municate their needs in a respectful manner. learned for fear the public would find out and
Leadership needs to be held accountable for rec- competitors would use the information against
ognizing issues early on and help the team mem- them. If the ambulatory industry felt safe to share
bers having a conflict deal with the issues openly errors and potential solutions many more errors
and properly [7, 8]. could be prevented.
Building a culture of safety takes an entire CMS says, “The ASC must develop, imple-
team and leadership must be actively involved ment, and maintain an ongoing, data-driven qual-
and support the team. Everyone must be held ity assessment and performance improvement
accountable for their actions and decisions with- (QAPI) program” [10]. The QAPI program must
out resorting to the “blame game.” Policies and be proactive. In order to be proactive, the leader-
procedures must be written clearly and describe ship team must provide time for the QAPI
the how they will be met by the ASC staff. Safety Coordinator and the QAPI committee members to
should not be a topic that is only addressed quar- meet, review, audit, and follow-up on issues identi-
terly when reports are due. Safety needs to be fied. The committee needs to be provided space so
addressed in an ongoing fashion. Reviewing doc- that the group can hold confidential conversations,
uments and processes, auditing for compliance to review and analyze data, make recommendations
policies, and the use of checklists are essential (solutions), and setup studies to test recommenda-
for leadership to be able to identify gaps and tions (solutions) to confirm the validity of the
address them in a timely before a safety issue improvement that it provides a safer process.
actually occurs [9]. The ASC’s Governing Board must identify
QAPI priorities for the center. The priorities must
focus on high risk, high volume, and problem-
uality Assessment Performance
Q prone areas in the ASC such as the preadmission
Improvement process where there is such a high volume of
interviews performed. Then a preadmission pro-
A Quality Assessment and Performance cess analysis is completed each month on the
Improvement (“QAPI”) program is the key to an effectiveness of the interview process. The QAPI
ASC practicing safely. The Risk Management, Committee could look at the analysis and see how
Pharmacy, Safety and Infection Prevention com- many patients canceled on the date of service and
mittees report to the QAPI committee within an how many patients were transferred to the hospi-
ASC. However, QAPI is only somewhat pro- tal after surgery and why. The priorities set by the
tected from discovery in case of a potential or Governing Board must consider how often the
actual malpractice suit or other lawsuit as some ASC could experience an incident and the sever-
states do not honor the confidentiality of the ity of the incident if experienced. The Governing
QAPI process. Other states, including the federal Board is obligated to look at the potential patient
government, see QAPI as important to improving outcomes, patient safety failure opportunities, and
patient care and solving problems and encourage the quality of care the ASC is providing.
The QAPI Committee members need to be Other useful tools at the QAPI committee’s dis-
educated in conducting comprehensive audits, posal: Failure Mode Effects Analysis (“FMEA”)
data analysis, and reviews of errors. If the facility that helps identify potential areas of failure in a
leadership team neglects educating the QAPI process, rank the failures, and correct them before
committee members on how to be effective com- a failure occurs [11]; Impact Analysis that helps
mittee members, the result is a QAPI program the committee explore the possible consequences
that does not meet the CMS requirements for cer- of a change; Kaizen that the idea of small changes
tification and does not promote patient safety. occurring continuously create a better system and
The key to a successful QAPI program is the that the people closest to the process should be
committee members being proactive and taking making the change. The QAPI committee should
their responsibilities seriously. include a cross-section of the segments of care;
The QAPI committee must understand how to thereby assuring people closest to the process are
perform root cause analyses. When performing a making the changes. All of the committees in an
root cause analysis, the committee must avoid ASC report findings and solutions through the
treating the “symptoms” of the problem. By QAPI committee to the Medical Executive com-
using the root cause analysis approach, the committee to the overall Governing Board.
mittee will focus on the origin of the problem and
thereby have the information needed to fix the
problem whether it be process or system related. Risk Management
The goal of using the root cause analysis process
is to determine what happened, why it happened, In an ASC, risk management is closely tied to the
and how to reduce the risk of it happening again. QAPI process. Risk management’s scope includes
What you hope to determine is whether the rea- writing and reviewing incident, occurrence, and
son for the error or near miss was physical (i.e., variance reports; controlling litigation to protect
tangible goods failed), human factors, or a sys- the ASC’s assets; focusing on underlying causes
tem failure; keeping in mind that it could be any for incidents and working with QAPI committee
combination of the three. The end goal is to dis- to reduce potential and actual harm; assisting in
cover what factors truly contributed to the spe- improving quality of care and patient safety; and
cific problem. Keep in mind the root cause working to determine potential risk for harm.
analysis could reveal more than one problem that The risk management process exists to protect
will need to be addressed. the patient, the staff, and the overall organization.
Once the root cause analysis is completed and A good risk management program is fully inte-
the information reviewed, the committee must go grated into QAPI and oversees regulatory com-
one step further and determine how to implement pliance, infection control and prevention, patient
the solution(s). A point person should be assigned safety, and employee safety. The risk manage-
to be responsible for the implementation, educa- ment process is designed to identify, analyze,
tion, and changes required. The committee should plan, and implement change, monitor and respond
determine if there are any risks in implementing to any risk or harm identified. The Risk Manager
the solution. If risks are identified, the committee is also trained to identify risk in the ASC for not
must review the risk(s) and determine if the solu- being or remaining in compliance with CMS and
tion is the proper path forward. The process used state licensure or accrediting body requirements.
to determine the risk of a solution is called the A well-trained Risk Manager can be responsible
cause-and-effect process. Using the cause-and- for billing and coding compliance as well as
effect process the QAPI committee will be able to HIPAA and OSHA. The key to a successful risk
plan ahead and resolve problems before they management program is education for the Risk
occur, thereby making it safer for the patient. Manager.
368 B.A. Kirchner
Environmental and Patient Safety has been approved by the leadership team, the
Safety Officer will begin to identify how to
CMS is very specific about their expectation of a implement the plan.
safe and sanitary environment. “The ASC must Internal emergency preparedness includes, but is
have a safe and sanitary environment, properly not limited to, the crash cart, malignant hyperthermia
constructed, equipped and maintained to protect cart, emergency generator, smoke detectors, and
the health and safety of patients” [12]. An ASC sprinkler systems. Some ASCs like to have an emer-
must comply with CMS requirements. In addi- gency airway cart for lost airways as well as difficult
tion, the ASC must meet state and accrediting intubations and other centers have Anaphylactic
body conditions. Shock boxes ready for use. The QAPI committee
“The ASC must comply with requirements makes recommendations to the Medical Executive
governing the construction and maintenance of committee on the type of emergency carts, supplies,
a safe and sanitary physical plant, safety from and equipment the center needs. The Medical
fire, emergency equipment and emergency per- Executive committee makes recommendations to
sonnel” [13]. In mid-2016, CMS notified the the Governing Board and then the Governing Board
ASC industry of the Federal Register change approves or makes recommendations and the deci-
where National Fire Protection Association sion goes back to the Safety Officer and QAPI com-
(“NFPA”) approved NFPA 101 (2012 Edition) mittee to implement.
A. NFPA 101, Chapter 6—Occupancy Types Internal disasters commonly identified are
NFPA 101, Chapter 8—Fire Protection cardiac arrest, respiratory arrest, patient transfer
Requirements and NFPA 99 (2012 Edition) to the hospital due to an error or other medical
ANSI 170—HVAC System Design. The changes issue, fire, loss of power, and water. It is the
go into effect on July 5, 2016. ASC have 1 year Safety Officer’s responsibility to survey using a
to comply with all changes that were not “grand- checklist based on the ASC’s potential for inter-
fathered.” Any new ASC being built has to have nal disaster or a problem with the building caus-
been permitted and have begun construction by ing a hazard to the patient, guest, and staff.
July 5, 2016, or the ASC will have to comply Holding mock drills quarterly and reviewing the
with the change. Many ASCs will struggle with process using a report card document is required
this change since most states have not adopted by CMS, accrediting bodies, and some states.
this change. If the state has not adopted the The drills must be documented. If gaps are noted
change made by CMS, the ASC will have to in the process during the drill, it is the Safety
work with the state to determine how to comply Officer’s responsibility to address the process
with both the state and CMS requirements. issue with the QAPI committee and Risk
ASCs must have policies and procedures Manager. The QAPI committee, Safety Officer,
describing how to monitor, track, and assess the and Risk Manager will analyze and determine
ASC’s safety plan to confirm the environment is how to eliminate the issue. Communication to the
safe for employees and patients. The safety plan staff is always important. The communication
includes environmental hazards and emergency needs to be clear and provide detailed directions
preparedness. Safety plans must be approved by on how to perform the task correctly.
the Governing Board. The safety plan must Potential external disasters are identified in
address risk and types of internal and external the risk analysis. The staff must be educated by
disasters that could occur based on where the describing their role during each of the potential
ASC is located. The risk assessment should be external disasters. ASCs are required to hold
completed first so that the high-probability risks external disaster drills. The drills need to be held
identified can be addressed in detail. ASCs must at least once annually to be in compliance with
work with the local disaster coordinator/office to CMS, other accrediting bodies, and state
determine the role an ASC will play in the event requirements.
of an external disaster. After the risk analysis is Safety Education will be provided at orienta-
completed and the ASC has written its plan and it tion and at least annually thereafter. The program
Table 23.2 General safety standards used for safety edu-

include documentation that the ASC has consid-
cation at orientation and, at least, annually at ASCs
ered, selected, and implemented nationally recog-
• Review of safety • Hazardous materials nized infection control guidelines” [14]. CMS is
policies and communication
very prescriptive in describing how an ASC must
procedures
• Body mechanics • SDS/hazardous waste
maintain an ongoing infection control and preven-
• Safety risks/ • Equipment safety/ tion program. The infection control and prevention
responsibilities operations manuals program is integrated into the QAPI Program. An
• MSDS/hazardous • Utility systems and ASC has the following national organizations it
waste electrical safety can use to develop and maintain its infection con-
• Infection control and • Reporting of sentinel trol and prevention policies, procedures, protocol,
prevention events, variances in
and surveillance checklist: Centers for Disease
practice, accidents,
injuries, and safety Control and Prevention (“CDC”), the Association
concerns for Professionals in Infection Control and
• OSHA • Fire and life safety Epidemiology (“APIC”), the Society for
• Security • Internal and external Healthcare Epidemiology of America (“SHEA”),
disaster and the Association of periOperative Registered
• Mock codes • Equipment safety Nurses (“AORN”) [14].
Infection control and prevention policies and
will address general safety processes: area- procedures must start with a mission statement
specific safety and job-related hazards. The gen- followed by scope of practice. The mission state-
eral orientation includes the general safety ment tells the staff and anyone surveying the cen-
standards in Table 23.2. ter what infection control guidelines are being
During orientation and annual follow-ups, the followed in the center and stresses the mission to
department/job-specific orientation will include have an infection-free environment. The guide-
specific safety standards related to safe practices lines can include a combination of recommenda-
and the safe use, inspection, cleaning, and main- tions from the national organizations. The
tenance of specialized equipment. At least annu- organizations used should fit with the population
ally, the safety in-service education will provide and type of cases the facility is performing. The
updated information and review concerns with scope of practice further defines the type of
all staff members. A review of all general safety patients, cases, and services being performed in
standards must occur at least annually. the center and must address at least the follow-
The Administrator/Nurse Manager and Safety ing: training provided for the Infection Control
Officer are responsible for assuring that employ- Preventionist Nurse, staff training, policies and
ees are provided with the safety standards per- procedures, risk assessment, establish infection
taining to their area of job responsibilities. All prevention goals, employee health program,
personnel are responsible for obtaining the infor- employee orientation, employee in-service edu-
mation necessary to perform a task in a manner cation program, surveillance methods and docu-
that prevents injury to themselves, patients, and mentation, monitoring for compliance to policies,
others. A review of the safety policies and proce- procedures, and program requirements, develop-
dures is required annually. ing and reporting system, evaluation of program,
Governing Board’s role in the program and
compliance with federal, state, and accrediting
Infection Control and Prevention bodies [15–17].
CMS requires that every center identify with
“The ASC must maintain an ongoing program standards for infection control and prevention.
designed to prevent, control, and investigate infec- Infection prevention and control begins when an
tions and communicable diseases. In addition, the ASC provides a clean and sanitary environment.
infection control and prevention program must The most important place to begin the infection
370 B.A. Kirchner
prevention and control program is with house- gen exposure and develop an exposure control
keeping. A well-trained staff who understands plan. The ASC leadership team must provide
why the area must be maintained (i.e., trash in education on blood-borne pathogens during ori-
appropriate containers, linen hampers emptied entation and procedures. The ASC needs a com-
frequently, clutter at a minimum) and all surfaces prehensive policy concerning Tuberculosis
cleaned properly with the correct product is a (“TB”) and exposure to TB.
staff that helps prevent infections. Training is the The ASC must address standard infection pre-
key to a clean and sanitary environment. Training vention precautions in the policies and proce-
begins during Orientation. Staff should be taught dures as well as in orientation and at least
how to clean surfaces between patients and after annually thereafter. The precautions that must be
patients use a stretcher, bedside table, or any addressed are hand washing, standard universal
other item. The ASC staff is taught to be fast and precautions, employee risk classification, task at
to turn over equipment, areas (i.e., preoperative risk, personal protective equipment (“PPE”),
bays, postanesthesia care unit bays, operating environmental and engineering controls, safe
rooms) leaving no downtime between patients. work practices, management of regulated waste,
Turning rooms quickly is a good practice so long management of contaminated equipment and
as being fast does not mean cutting corners. handling of laundry (i.e., clean, soiled).
Leadership must also be aware of the time needed Transmission-based precautions are addressed in
to properly clean after each patient based on the these policies and procedures. The staff must
type of case and amount of equipment used in the understand how to identify a patient or guest with
case. For example, it takes minutes to turnover a a potentially infectious disease and how they are
Bilateral Myringotomy Tube placement because to address the potential infection exposure to
there are no liquids being used and it is a mini- staff and other patients and guests. One area of
mally invasive procedure versus turning over a difference between older and newer ASCs is iso-
major shoulder case which used at least ten pieces lation rooms. Many new ASCs are building isola-
of equipment, has thousands of milliliters of flu- tion preoperative and PACU rooms. The staff
ids used, and a large number of instrument pans must be trained on how to educate patients and
opened and used. Fast is good… but fast cannot visitors on ways to reduce the transmission of
compromise patient care or patient safety. infections and communicable diseases. Today,
Employee health is addressed under the infec- many ASCs are providing hand-washing bro-
tion prevention and control policies and proce- chures with instructions in the postoperative edu-
dures. The ASC must obtain the immunization cation patient packets. It has been generally
records of all employees, credentialed staff (i.e., accepted that educating patients and families on
physicians, allied health), and vendors. The cen- good hand hygiene reduces the potential for sur-
ter must have policies addressing employee gical site infections [19, 20].
infectious diseases and work restrictions based Identifying and monitoring infections is a
on the disease. All employees, physicians, allied requirement of CMS, state health departments,
health, and anyone working a day in the ASC and accrediting bodies. ASCs must follow up
must show they have been vaccinated for the flu with the surgeon requesting infection informa-
annually during flu season. If anyone working in tion on every patient the surgeon has performed a
the center is not able to take the vaccine for any procedure on in the ASC. The first contact made
reason, the center must have a policy on how to by the ASC concerning infection is 30 days after
address the employee who is not vaccinated for the original date of procedure. ASCs strive to
the flu. The ASC must report annually through obtain 100 % compliance on receiving an infec-
the National Healthcare Safety Network tion report on every patient seen in the ASC. The
(“NHSN”) the ASC’s compliance rate to the flu ASC must track patients for infections if they
vaccination program. Infection plan also received an implant for 90 days. The infection
addresses work injuries and how they are handled control information (data) must be reviewed,
[18]. The center must address blood-borne patho- analyzed, and reported to the QAPI committee,
Medical Executive committee, and Governing 5. Pennsylvania Patient Safety Collaboration. Pervasive
commitment to patient safety. 3.
Board. If an infection is identified, the Infection
6. Pennsylvania Patient Safety Collaboration. Open
Control Preventionist Nurse must investigate the communication. 4.
infection and identify the potential source. It will 7. http://www.forbes.com/sites/mikemyatt/2012/02/22/5-
be the Infection Control Preventionist Nurse’s keys-to-dealing-with-workplace-conflict. Accessed
May 2016.
responsibility to identify the potential gaps in
8. http://money.usnews.com/money/careers/articles/
practice and to educate the staff to eliminate the 2012/07/18/10-tips-for-tackling-the-toughest-workplace-
gaps identified. conflicts. Accessed May 2016.
9. Lebedun J. Managing workplace conflict. Virginia
Beach: Coastal Training Technologies Corp.; 1998.
10. Pennsylvania Patient Safety Collaboration. Blame

Conclusion free environment. 4–6.
11. Healthcare failure mode and effects analysis educa-
The ASC is focused on providing care for patients tion and worksheets. http://www.patientsafety.va.gov/
professionals/onthejob/HFMEA.asp.
needing a surgical or procedural intervention.
12. State operations manual appendix L—guidance for sur-
The ASC can be a very safe place for the patient veyors: ambulatory surgical centers. Interpretive guide-
to receive surgical care so long as the Governing lines: §416.25. Q-0002 (Rev. 95, Issued: 12-12- 13,
Board and leadership team strive to follow the Effective: 06-07-13, Implementation: 06-07-13).
§416.43 Condition for coverage: quality assessment and
rules, regulations, and standards that govern
performance improvement. Q-0101 (Rev. 137, Issued:
ASCs. The key to a successful outcome for a 04-01-15, Effective: 03-27-15, Implementation: 03-27-
patient is a highly trained staff who understands 15) §416.44(a) Standard: physical environment. Q-0241.
the principles of safe practice. The ASC industry (Rev. 56, Issued: 12-30-09, Effective/Implementation:
12-30-09) §416.51(a) Standard: sanitary environment.
began in the mid-1970s and has grown into an
13. State operations manual appendix L—guidance for
industry of over 4500 freestanding facilities that surveyors: ambulatory surgical centers. Interpretive
are licensed and/or accredited and Medicare cer- guidelines: §416.25. Q-0002 (Rev. 95, Issued: 12-12-
tified. The industry is expanding its scope of 13, Effective: 06-07-13, Implementation: 06-07-13).
Q-0104 (Rev. 95, Issued: 12-12-13, Effective: 06-07-
practice taking on more and more complicated
13, Implementation: 06-07-13) §416.44(b) Standard:
cases thanks to advancement in technology and safety from fire.
the demands of the public, thus driving the need 14. State operations manual appendix L—guidance for
for ASCs to track patient outcomes and closely surveyors: ambulatory surgical centers. Interpretive
guidelines: §416.25. Q-0002 (Rev. 95, Issued: 12-12-
assess their practice for quality safe care. The
13, Effective: 06-07-13, Implementation: 06-07-13).
ambulatory industry values quality safe care as Q-0242 (Rev. 56, Issued: 12-30-09, Effective/
proven by the creation of the not-for-profit, self- Implementation: 12-30-09) §416.51(b) Standard:
funded organization that addresses quality and infection control program.
15. Carroll R. Risk management handbook for health care
safety, the ASC QC. organizations. American Society for Healthcare Risk
Management (“ASHRM”); 2010.
16. www.oneandonlycampaign.org. Accessed May 2016.
References 17. Quality Net. http://qualitynet.org. Accessed May 2016.
18. Center for Disease Control and Prevention, Healthcare
Safety Network (“NHSN”). [email protected] include
HPS Flu Summary-ASC in subject line. Accessed
surveyors: ambulatory surgical centers. Interpretive
May 2016.
19. Quality Reporting Center HSAG. http://www.quality-
reportingcenter.com/. Accessed May 2016.
§416.2 Definitions.
20. CMS ASC quality reporting program quality mea-
2. ASC quality collaboration website (measure and sum-
sures specification manuals. www.qualitynet.org.
mary implementation guide). http://ASCQuality.org/
Accessed May 2016.
qualitymeasures.cfm. Accessed June 2016.
3. Federal Register/Vol. 80, No. 219/Friday, November
surveyors: ambulatory surgical centers. Interpretive
13, 2015/Rules and Regulations. http://www.gpo.gov/
fdsys/pkg/FR-2015-11-13/pdf/FR-2015-11-13pdf.
Accessed June 2016.
Q-0040 §416.41 Condition for coverage: governing
4. Leap LL. Pennsylvania Patient Safety Collaboration,
body and management.
quote, 2.
Human Factors and Operating
Room Design Challenges 24
Dirk F. de Korne, Huey Peng Loh,
and Shanqing Yin
“Reliable human-system interaction will be best achieved by designing interfaces that

minimize the potential for control interference and support recovery from errors”.
—Charles Vincent and René Amalberti, from Vincent C, Amalberti R. Safer healthcare:
strategies for the real world. Springer Open, 2016:55.
idea, practice, or objective perceived as new by an

perating Rooms as Socio-technical
O individual, a group, or an organization”, and dif-
Environments fusion is “the process in which an innovation is
communicated, through certain channels over
Diffusion of Innovation time, among the members of a social system”. As
Greenhalgh et al. [14] indicate, diffusion often is
Operating rooms (ORs) are rich and complex
not a passive process but involves negotiating,
socio-technical environments where technology
influencing, and enabling a work staff that can
and human actions are closely interwoven and
enable change and “help it happen”. Examples of
outcomes are co-dependent on the success of this
recent innovations diffused into health care are
interaction. Operating rooms are not unique in
the investigative tool of root cause analysis and
this regard, and diffusion of innovations from
the surgical checklist [15]. The framework to
other complex environments (e.g. high-risk
analyse the diffusion of innovations developed by
industries such as nuclear power, offshore, and
Greenhalgh et al. [14], see Table 24.1, is a useful
aviation) into health care to improve safety has
tool to focus on the factors that determine actual
been advocated by many authors [1–12].
diffusion. In this chapter, we will use the frame-
According to Rogers [13], an innovation is “an
work to analyse the applicability of innovations
from other industries to improve safety and qual-
ity in surgical patient care.
D.F. de Korne, PhD, MSc (*)
Medical Innovation & Care Transformation,
KK Women’s & Children’s Hospital,
100 Bukit Timah Road, Singapore 229899, Singapore
e-mail: [email protected] Risks in the Operating Room
H.P. Loh, MHA
Operating Theatre, Singapore National Eye Centre Operating rooms (ORs) are high-risk areas for
(SNEC), 11, Third Hospital Avenue, preventable patient harm [16–18]. Besides
Singapore 168751, Singapore wrong-
site surgery and medication or instru-
ment-related incidents, surgical site infection
S. Yin, PhD, BSc (SSI) has been reported to be one of its major
Department of Quality, Safety, & Risk Management,
categories [16, 17, 19–21]. For example, bacte-
KK Women’s & Children’s Hospital,
100 Bukit Timah Road, Singapore 229899, Singapore rial air and fomite contamination are generally
e-mail: [email protected] accepted as the main causal risk factor of SSIs

374 D.F. de Korne et al.
Table 24.1 Analysis framework for diffusion of innovations [14]

Feasibility of changing
practice, procedures, and
context of hospital to match
System A (e.g. airline) System B (e.g. hospital) airline
The innovation Salient features currently used Salient features of innovation Could and should System B
in System A? proposed for use in System B? adopt the same innovation
as is used by System A?
The resources What resources were used in What resources in System B? Does System B have the
producing the outcomes (e.g. resources to emulate the
staff time, money, equipment, practice of System A?
space)?
The people What are the salient What are the characteristics of Insofar as there is a
characteristics of the key the key actors in System B? mismatch, would it be
actors in terms of expertise, desirable or feasible to
experience, commitment? recruit different staff, invest
in training, etc.?
Institutional How much were the outcomes To what extent does the Differences? Feasible or
factors dependent on organizational/ organizational structure and desirable to change the
departmental structure, culture of System B determine institutional structures and
organizational cultures? practice? cultures in B?
Environmental How much were the outcomes To what extent is the external Differences? Change the
factors dependent on particular environment of System B external environment of
environmental factors (e.g. comparable to System A? System B?
political, legislative, etc.)?
Measures What baseline, process, Does (or could) System B use Desirable or feasible for
outcome, and other measures the same measures? System B to change the way
were used to evaluate success? it measures and records
practice?
Procedures What was exactly done in Does (or could) System B do Differences? Should System
System A that led to the exactly the same? B change what it does?
outcomes reported?
Outcomes What were the key outcomes, What were the key outcomes To what are the differences
for whom, at what cost, and in System B? Achieve for attributable? Desirable
what are they attributable to? same actors as A? outcomes that System B is
not achieving?
Source: de Korne DF, van Wijngaarden J, Hiddema F, Bleeker FG, Pronovost PJ, Klazinga NS. 2010. Diffusing aviation
innovations in a hospital in the Netherlands. Jt Comm J Qual Patient Saf 36(8):339–347
[19, 20, 22, 23]. Proper ventilation in and near have shown the effects of LAF ventilation on the
the OR coupled with rigorous hand hygiene is number of contaminations of samples in different
key in establishing an environment that stops the OR areas [19, 20, 22].
spread of infection [24, 25]. Since Lidwell et al. In the past 30 years, much attention has been
in 1982 demonstrated a correlation between air- given to the proper installation of LAF systems
borne bacteria contamination levels and the inci- as well as details about its size, position, concen-
dence of postoperative wound infections, the use tration, efficiency, degree of filter, temperature,
of ultraclean ORs with laminar air flow (LAF) and other technicalities [26]. The actual effect of
ventilation has been recommended for many the clean air, however, is largely dependent on
types of surgery [19, 20, 22]. With LAF, cold, the correct positioning of the surgical table and
clean air is blown into the OR from a ceiling sys- instruments in its flow as well as staff traffic
tem and contaminated air is sucked out through behaviour and patterns (e.g. number of people
ventilation grids in the walls. Different studies standing within the flow or against wall vents)
24 Human Factors and Operating Room Design Challenges 375
[22, 23, 25–28]. Energy from movement of designer through embedded affordances and con-
devices and staff decreases the volume of clean straints. In operating rooms, human factor engi-
air and both hinder air flow [25, 28]. neering and design thinking therefore plays an
In most literature on hygiene and infection important role in safety and efficiency improve-
studies, the focus is on teaching, training, and ment. An unacceptable number of avoidable
changing staff behaviour, e.g. appropriate OR patient safety incidents result from the widening
dress or hand hygiene discipline [16, 17, 19, 22, disparity between surgical innovation and the
25, 27]). Adhering to infection prevention recom- environment in which it is applied [43, 44].
mendations like correct positioning of devices Design that aims to minimize the increasing
within the clean air flow is rarely emphasized, problem of patient safety must consider the
despite infection prevalence being dependent on behaviour of staff and patients as well as the
design characteristics of the OR. complex interrelationships between culture; tech-
Most safety improvements in high-risk indus- nology; and achieving reliable, high-quality sur-
tries first focus on work area design—here defined gical outcomes [44]. While OR floor marking is
as ‘creating and developing concepts and specifi- increasingly applied in the design of ORs, little is
cations that optimize the function value and known about its effects on clean air compliance.
appearance of products and systems for the
mutual benefit of both user and manufacturer’
[29]—before attempting to change behaviour. ase Study I: Effects of Operating
C
Many studies performed in industry have con- Floor Marking on the Position
cluded that it is hard to change behaviour; chang- of Surgical Devices1
ing design is probably easier [30–34]. On offshore
oil vessels, for example, the position of all materi- The application of OR floor marking at the
als on decks is marked to support safe behaviour Rotterdam Eye Hospital, The Netherlands (REH)
[35], as are the positions of airplanes and all sur- was part of a safety learning programme between
rounding equipment on the airport tarmac [36]. surgical staff at the hospital and terminal opera-
Human factor engineering, concerned with the tors at Amsterdam’s Schiphol Airport. While the
understanding of interactions among humans and direct purposes of floor marking are obviously
other elements of a system, can help in ‘mistake different for airside and OR (prevention of colli-
proofing’ by changing designs to make processes sions and logistic support in a dynamic environ-
more reliable and effective [21, 37]. Influencing ment versus infection prevention and proximity
users’ behaviour is challenging and smart design for ease of use in a relatively static environment),
can potentially shape behaviour towards sustain- the main goal of doing the right things on the right
able practices and improve teamwork dynamics spot is similar. The hospital used a laminar flow
and situational awareness [38, 39]. Teamwork system with an inflow of 0.27 m/s, from a ceiling
has been defined as ‘skills for working in a group rectangle area of 160 × 220 cm, and with a total
context, in any role, to ensure effective joint task content of 124.5 m3 per OR (See also Fig. 24.1a).
completion and team member satisfaction’ [40]. The relative humidity was 55 % and the tempera-
Situational awareness has been defined for this ture was 19.5 °C. The ventilation rate was calcu-
context as ‘developing and maintaining a lated at 20.5 per hour. An OR workspace analysis
dynamic awareness of the situation in theatre was performed, indicating 42 different items on
based on assembling data from the environment, various positions. The following equipment was
understanding what they mean and thinking routinely used during ophthalmic operations: sur-
ahead what might happen next’ [41]. Behaviour gical table, one (mostly) or two (e.g. for more
steering could be used as a strategy that could be
integrated into product design [33, 42], encour-
1
aging users to behave in ways prescribed by the This case study has been published as de Korne et al.
BMJ Qual Saf 2012; 21(9):746–52, ref. [45].
Fig. 24.1 (a) Position of surgical devices at the operat- 2010). Source: de Korne DF, van Wijngaarden JD, van
ing room (photo: REH). Source: de Korne DF, van Rooij J, Wauben LS, Hiddema F, Klazinga NS. Safety by
Wijngaarden JD, van Rooij J, Wauben LS, Hiddema F, design: effects of operating floor marking on the position
Klazinga NS. Safety by design: effects of operating floor of surgical devices to promote clean air flow compliance
marking on the position of surgical devices to promote and minimize infection risks. BMJ Qual Saf 2012;
clean air flow compliance and minimize infection risks. 21(9):746–52. (d) Provisional surgery floor marking for
BMJ Qual Saf 2012; 21(9):746–52. (b) Overview of the T1 and T2 (photo: REH). (e) Permanent surgery floor
OR floor and space analysis (photo: REH). (c) Airside marking for T3 (photo: REH)
marking at Amsterdam Airport Schiphol (Schiphol
extensive retina surgery) instrument tables, Mayo of virtually all ophthalmic surgeries are required
instrument stand (e.g. for retina surgery and cata- to have an LAF [46]. We studied the potential
racts with general anaesthesia), surgical lamp (for relationships between equipment position and
oculoplastic and strabismus surgery), chair for endophthalmitis (an internal inflammation of
surgeon, chair for assistant (resident or surgical the eye), the most common infection in intraoc-
nurse), medicine and disposable material trolley, ular surgery, particularly cataract surgery, which
anaesthesia instrument, chair for anaesthesiolo- can result in loss of vision or the eye itself [47].
gist, phacoemulsification and vitrectomy machin- A mixed methods study was done including
ery for cataract, respectively, vitreoretinal surgery interviewing providers and doing a detailed
(See Fig. 24.1b). time series analysis to measure compliance (the
The REH is a major referral centre, handling position of devices within the clean air flow) 5
approximately 140,000 outpatient visits and months before marking (T0, n = 180 surgeries),
14,000 surgical cases annually. According to and at 1 month (T1, n = 194 marked, n = 86 not
Dutch infection prevention guidelines, the ORs marked), 6 months (T2, n = 166 marked), and 20
Fig. 24.1 (continued)
departing planes, fuel and luggage devices, and

vehicle and foot traffic (Fig. 24.1c).
During two hospital sessions, OR traffic
flows, position of surgical tables and materials,
safety management, and incident reporting were
discussed. Marking was applied to two of the
four ORs. Red tape (width 2.5 cm) was pasted on
the contours of the laminar flow area
(162 cm × 224 cm) of the OR floor (Fig. 24.1d).
The stop positions of the surgical tables were
indicated by white tape dots. In a second phase a
permanent mark was applied (Fig. 24.1e).
Surgeons, nurses, and other staff were not spe-
cifically instructed to change the positioning of
the devices. After T0 documentation of position-
ing, compliance with laminar flow was deter-
mined based on device positioning at T1–T3. The
results are presented in Table 24.2.
Instrument table. Before marking, the instrument

table was positioned completely within the lami-
nar flow in only 6.1 % of the cases. With floor
marking, this significantly increased to 36.1 %
(T1, p = 0.000), 52.1 % (T2, p = 0.000), and finally
Fig. 24.1 (continued) 53.8 % (T3, p = 0.000). At T1, only 10.7 % of the
instrument tables in the ORs without floor mark-
ing was positioned completely within the laminar
flow. At T2 and T3, in almost half of the cases,
months (T3, n = 199 marked). The positions of the instrument tables were still positioned (partly)
devices, mobile OR table, instrument table, outside of the clean air flow. In interviews, staff
Mayo stand, and surgical lamp were determined indicated that in their view an ergonomically cor-
by four circulating nurses (Fig. 24.1a). rect position is more important than positioning
the instrument table in the clean air flow. For
some operations a diagonal position is necessary,
Floor Marking Effects requiring more space. The size was also criti-
cized: “For retinal surgery, you can’t position a
The marking project was a co-creation of a mul- resident and a scrub tech and all your instru-
tidisciplinary team with hospital surgical staff ments in the flow area. The field is too small”
and tarmac operators from Schiphol airport.2 (ophthalmic surgeon).
Five mutual site visits were included. During
three airport sessions, experience in airside mark- Mayo stand. Mayo stands (above the patient)
ing, position of materials, traffic flows, safety were increasingly positioned within the laminar
rules and regulations, and incident management flow after marking: from 74.2 % (T0) to 82.8 %
were discussed. Different colours and patterns (T1), 84.6 % (T2), and 84.7 % (T3). These
indicate the exact position of approaching and changes were not statistically significant. The
number was expected to approach 100 % because
2 the stand is normally positioned close to the
Benchmarking with aviation was part of a larger safety
focus; for details see de Korne et al. Jt Comm J Qual patient. In certain surgeries, however, it was
Patient Saf 2010;36(8):339–347, ref. [48]. placed at a distance because as one surgeon
Table 24.2 Percentages of surgeries with the instrument table, Mayo instrument stand, and surgical lamp in the
laminar
T0 T1 T2 T3
n = 182 n = 86 n = 195 n = 167 n = 199
Not Not
marked (%) marked (%) Marked (%) Marked (%) Marked (%) p Value
Instrument table Completely in 6.1 10.7 36.1 52.1 53.8 0.000a
Partly out 26.7 72.6 37.6 27.0 27.6
Largely out 67.2 16.7 26.3 20.9 18.6
Mayo Completely in 74.2 82.4 82.8 84.6 84.7 0.080c
instrument Partly out 18.2 8.8 8.7 9.0 15.3
standb 7.6 0.0
Largely out 8.8 8.5 6.4
Surgical lampd Completely in 41.8 35.8 38.7 28.7 48.6 0.000a
Partly out 15.7 22.4 6.5 4.7 0.7
Completely out 42.5 41.8 54.8 66.7 50.7
Source: de Korne DF, van Wijngaarden JD, van Rooij J, Wauben LS, Hiddema F, Klazinga NS. Safety by design: effects
of operating floor marking on the position of surgical devices to promote clean air flow compliance and minimize infec-
tion risks. BMJ Qual Saf 2012; 21(9):746–52
χ test T0not marked − T1marked
a 2
b
Includes only cases where the Mayo instrument stand was used (34 %)
χ test T0not marked − T3marked
c 2
d
Excludes oculoplastic and strabismus cases because the surgical lamp is in use
noted: “Having sufficient space to move and (Table 24.3). Due to very low incidence (0.078 %
position your arms is more important for a suc- in 128,130 cases over previous 11 years), no
cessful surgery than the position in the flow”. significant differences could be found. Notably,
changes in corneal versus corneoscleral inci-
Surgical lamp. In many ophthalmic surgeries sions and the use of prophylactic antibiotics
(with the exceptions of strabismus and oculoplas- probably acted as confounders and it is not sure
tic surgeries) the microscope light is used instead whether besides this associative relation there is
of the surgical lamp. To maximize clean air flow, also a causal relation.
the surgical lamp should then be positioned out- According to interviewed staff, discussions
side the area since its volume and energy disturb and site visits between airside operators and sur-
clean air flow. In such cases, the surgical lamp gical staff resulted in an increased awareness of
was decreasingly positioned in the flow: from the specific risk areas in the OR. Due to the
41.8 % (T0) to 38.7 % (T1, p = 0.000) and 28.7 % exchange sessions, professionals not only
(T2, p = 0.000). However, at T3 (20 months after focused on the position of the surgical table, but
the marking) in 48.6 % of the cases the lamp was were more aware of the complete air flow area,
again positioned in the air flow. In interviews, including the instrument table positions.
staff indicated that they often forgot to reposition Therefore, the surgical table’s stop position was
it because, according to them, there is no clear permanently marked (T3). The surgical team
marking. usually focused on the position of the patient in
“There’s an indication of the clear air flow on the clean air flow. During discussions about risks,
the floor now, but not in 3D. If we were doing however, the focus was on the total risk surfaces.
surgery in a real clean air box, all disturbing Since the wound surface in ophthalmic surgery is
devices could be eliminated” (nurse). very small, the materials used appear to play a
In the 2 years after the marking, the inci- larger role. For example, surgical staff indicated
dence of ophthalmic infections (endophthalmi- that they became aware that donor tissue for a
tis) was lower than in the 4 years before corneal transplant was placed outside of the flow:
380
Table 24.3 Endophthalmitis infection statistics at the case hospital, 2000–2010

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Total surgeries 9701 9955 10,328 10,428 11,199 11,864 12,692 12,610 13,338 13,242 12,773
Postoperative 7 (0.072 %) 9 (0.090 %) 8 (0.077 %) 6 (0.058 %) 12 (0.105 %) 10 (0.084 %) 10 (0.078 %) 14 (0.102 %) 9 (0.067 %) 7 (0.053 %) 8 (0.063 %)
endophthalmitis
infections in all
surgeries
Cataract surgeries 4986 5018 5126 5274 6011 6015 7040 6893 7366 7442 7164
Postoperative 4 (0.080 %) 5 (0.099 %) 7 (0.136 %) 4 (0.076 %) 11 (0.083 %) 7 (0.116 %) 3 (0.043 %) 8 (0.116 %) 5 (0.068 %) 5 (0.067 %) 3 (0.042 %)
endophthalmitis
infections in
cataract surgery
Source: de Korne DF, van Wijngaarden JD, van Rooij J, Wauben LS, Hiddema F, Klazinga NS. Safety by design: effects of operating floor marking on the position of surgical devices
to promote clean air flow compliance and minimize infection risks. BMJ Qual Saf 2012; 21(9):746–52
D.F. de Korne et al.
“The donor cornea is prepared in the laminar flow. needed) but this was not sustained. The marking
When the patient arrives at the OR, we reposition
seemed to have created an initial awareness, but
the instrument table with the donor tissue. Through
the marking, we became aware that the donor cor- perhaps because the marking on the floor and the
nea is not in the clean air flow during heavy traffic lamp hangs on the ceiling, the marking did not
flows (patient arrival, staff entry) at the first part of help to sustain the behaviour to position the lamp
the surgery” (surgeon).
outside the clean air area.
Some ophthalmic surgeons were sceptical

about the marking initiative at the start. Clean air ase Study II: Video Feedback
C
flows were seen as important to prevent infec- to Improve Sensomotor and Non-
tions, but due to low infection rates in ophthal- technical Skills3
mology it was in their view not worthwhile to use
marking and measure compliance. Confronted ensomotor and Non-technical
S
with the compliance results after the marking, Factors in the Operating Room
they indicated that marking seemed to increase
awareness and good positioning. Over the last decade, ORs have consistently been
“Marking not only encourages staff to position the indicated as high-risk areas for preventable harm,
patient and instruments correctly, it also makes yet the factors contributing to complications and
clear that non-sterile visitors have to stay outside surgical confusion within this context are usually
the marked area” (surgeon). multifactorial and remain poorly understood
[43]. Poor surgical outcomes may result from a
The circulating and scrub nurses found that combination of surgical complications resulting
they positioned the instruments increasingly in from poor surgical technique, or suboptimal OR
the laminar flow since the marking project with- support resulting from inadequate communica-
out being aware of any differences. Only when tion among the surgical team, or an interplay and
they saw the results were they convinced that combination of the earlier two major aspects of
positioning had changed. The new design nudges OR safety [50].
for a compliance improvement without a need for Traditional training of surgeons is focused exclu-
specific instructions or even explicit awareness of sively on developing and training technical (surgi-
the staff involved. cal) skills [51]. However, an analysis of the reasons
for surgical adverse events revealed that these events
stem from behavioural or non-technical aspects of
arking Floors as Improvement
M performance (e.g. poor communication among
Design Intervention members of the surgical team) [50, 52]. Surgical
training of new surgeons within this complex envi-
Marking the clean air area on the floor of ORs ronment is highly dependent on a supervisor–
resulted in significantly increased compliance trainee trust and mentorship in a one-to-one training
with the positioning of surgical devices. While model. Objective assessment and monitoring of sur-
the focus was previously on the position of the gical skills with the goals of enhancing learning and
patient, the marking resulted in a focus on posi- improving resident outcomes are crucial [53].
tioning instrument tables within the clean airflow. However, current training schemes have shown to
The change was sustained over time. Drawing a be subjective with significant intersupervisor vari-
simple line created awareness and resulted in disability and significant variation in style and consis-
cussions about the required surface and the cor- tency of feedback [54, 55].
rect position of devices and staff. At first, the
surgical light was more often put in the right 3
Parts of this case study were published as de Korne et al.
position (out of the clean airflow when not J Health Organ Manag. 2014;28(6):731–53, ref. [49].
There is therefore a need to explore more involved in the programme. In the end, 70 % of
objective assessment methodologies to assess sur- the ophthalmologists participated in the training.
gical expertise [56]. Operating room safety has
admittedly improved with measures instituted
such as ‘Time Out’ (to ensure operating on correct
Awareness of Risks
side, site, procedure, etc.), education with regard
to needle stick injuries/lost or flying needles/miss-
Awareness of risks was observed via the video
ing swabs, ensuring the safety and availability of
analysis. From the staff interviews and
surgical instruments, and sterile procedure to
observations, it was clear that anticipation of

name a few. Despite numerous costly measures
approaching safety threats was a recurrent ses-
already in place, reportable incidents still occur,
sion topic. Participants talked about a lack of
some of which are serious [21]. We have therefore
standards and interoperability and requested this
explored the application of video recordings.
be addressed:
“There are no strict protocols for what I do and
what the surgeon does. Continuous evaluation and
ideo Feedback as Means
V
risk assessment depends on the surgeon [alone]”
for Improvement (resident).
The hospital initiated a Team Resource As a result of the discussions, multidisci-

Management (TRM) Programme with top man- plinary, standard operating procedures were
agement participation. Video feedback was to be agreed upon, including a pre-operative briefing
used and is recognized as a very useful approach (with task division) and time out. The importance
in reviewing and understanding work processes of situational awareness and the influence of
as well as a means for quality improvement [57, human factors were a recurrent topic in the video
58]. Inspired by aviation, a ‘black box’ approach feedback items (Table 24.4). The videotapes
was introduced in one of our hospitals. Aviation revealed team-specific differences in performing
safety experts videotaped ophthalmic surgeries the time-out procedure and the variation in using
monthly to give the surgical team feedback on the the safety communication rules agreed on during
application of the safety procedures taught dur- the TRM training. The videos also showed that
ing the classroom TRM sessions. Standard oper- the absence of team members at the pre-operative
ating procedures for the production, use, and briefing resulted in less structure and more com-
distribution of the images were documented. The munication gaps during surgery. As one aviation
aviation black box is automated, but for financial safety expert said,
constraints the hospital used a handheld video “It is a new and inspiring experience for ophthal-
recorder. mologists to see their own performance … within
their environment. It confirms the notion that sur-
Videotaping team activities was not easily
gery is a team activity”.
accepted and the medical staff was initially hesi-
tant, fearing that recorded unexpected outcomes It was difficult for staff to deny teamwork fail-
could be used against them. Only ophthalmolo- ures when they were clearly revealed on tape.
gists who participated in the larger TRM One video showed how a lack of briefing resulted
Programme consented to having their surgeries in indecisive behaviour of a resident and an unex-
videotaped, but with the stipulation that the pected movement of a locally anesthetized
images be taken with a handycam and used solely patient. During the feedback session with staff,
for their own training. The chief ophthalmolo- most ophthalmologists blamed the resident. The
gist, who had declared his willingness in an ear- TRM trainer, however, confronted the ophthal-
lier stage of the programme, consented to make mologist rather than the subordinate resident
the recordings available to all the hospital’s staff, with the situation and focused on a responsible
residents, and nurses, stimulating others to get leadership role.
Table 24.4 Examples of video observations and feedback to surgical team

Item Observation Feedback
Mental preparation Before the patient was on the operating The performing surgeon is not able to prepare
table, who (attending or resident) was mentally and obtain situational awareness
supposed to perform the surgery had not
been agreed on
Briefing After the patient arrived in the operating A “captain” needs to have situational
room, a resident and student received a awareness regarding the competencies of the
medical–technical explanation about the colleague performing the operation. To prevent
procedure. There was no talk about who such errors, he or she briefs him before on
would be performing what actions or what to expect, so the situational awareness of
potential problems. As it turned out, the the “co-pilot” is updated. The co-pilot can ask
resident was prepared to do so questions or be asked to jump in during the
surgery. This was not made clear to the team
Projection The ophthalmologist discussed the This is a good example of correct projection of
surgical schedule for the day and indicated tasks and managing of resources
that the first surgery in the afternoon was
expected to last 2.5 h. He asked the team
to plan their lunch time accordingly
Time out The time out was performed, but there How can we ensure that the time-out
was no check against the information in procedure is performed in a standard manner?
the medical chart
New instrument Halfway during surgery, a scalpel with The fact that surgeons did not know about the
new tip was on the surgical table. The new tip can be observed as a “threat” from the
surgeons did not know why organization. Are the communication
procedures from the organization to surgeons
sufficient, and did the team take responsibility
and sufficient measures to prevent errors from
such threats?
Communication The surgeon asks for an intraocular lens When the IOL is unpacked, it was shown to be
(IOL) and the circulating nurse gets one. the wrong one. Why not close the
Before putting it on the table, she says communication loop before unpacking the IOL
“20” but did not receive a response from or implement a check moment before?
the surgeon. After a while, the surgeon
asks to see the chart to check the IOL
power
Communication Frequently, a task or some material is Communication at surgery is limited (e.g.
required, but is not repeated in a covered face, working hands, not looking at
standardized manner to confirm that it is each other), which every team member should
understood be aware of and try to compensate for. Closing
the communication loop during handovers
(repeating an assignment, saying “check” or
“yes”) seems useful
Assertiveness As the ophthalmologist prepared to wash The circulating nurse’s assertiveness was
the eye, the circulating nurse asked if the perfect, as was the reaction of the
right method and material were used ophthalmologist
Source: de Korne DF, Van Wijngaarden JD, Van Dyck C, Hiddema UF, Klazinga NS. Evaluation of aviation-based
safety team training in a hospital in The Netherlands. J Health Organ Manag. 2014;28(6):731–53
Aversion to Error Reporting was called a complication. Today we say, no,

weather conditions can be anticipated, so don’t
call it a complication”.
Team members were convinced that eye surgery
is highly unpredictable and most complications This seemed to create an awareness and
are not preventable. The trainer responded: resulted in discussions about the differences
“You’re talking about complications like we did in between complications, medical errors, and
aviation 30 years ago. Bad weather, for instance, adverse events. The number of reported near
misses increased by about 300 % (from 78 to “I don’t see myself telling anaesthetists that they
409) in the 3 years following the introduction of have to react to beeps of their equipment. That’s
their responsibility” (ophthalmologist).
the video feedback programme. Some surgeons,
however, indicated that reporting errors was still The aviation expert, however, explained that
difficult. each team member influenced patient outcomes.
“You know that you’re not guilty or being blamed, Staff indicated that the training revealed basic
but it still feels like it” (ophthalmologist). communication (mis)understandings between
professionals:
Only 18 % of the (near) incident reports over the “During medical training you only learn how to be
past 3 years were submitted by ophthalmologists, a technically good ophthalmologist. You learn
while the rest was reported by nursing and admin- from your supervisor. I have never learned any-
istrative staff. This low percentage of physician thing about team communication, other than from
experience” (ophthalmologist).
reporting has been showed before [59]. A retro-
spective analysis of medication incidents reported Team Resource Management training dis-
using an online reporting system showed that 9.1 % cusses the mental models that various team mem-
were reported by doctors, 37.6 % by nursing staff, bers share and has shown to be effectively related
and 51.9 % by pharmacists [60]. to various team skills [62]. It has shown to be
Considering the one-to-one supervision model effective in changing participants’ mental model
in which residents are trained, leading by exam- about errors and risks [63] and thereby can be
ple turned out to be a crucial factor influencing used as a vehicle to stimulate safety culture.
error reporting. “Basically you’re looking at the
work practices of your supervisor and trying to
copy that” (resident). Others indicated that they utomated Versus Handheld Video
A
were highly dependent on the existing leadership Feedback
culture. “You have to take the culture for granted;
you know it’s part of the game when you want to Cataract surgery is one of the most performed
become a specialist” (resident). During the surgeries in the world, uses sophisticated equip-
debriefing sessions, senior ophthalmologists ment and is process fairly uniform. IOL-related
claimed there were no barriers for residents to confusions have been consistently identified as
talk about errors. Residents did not agree: “I can- one of the most common surgical errors.
not comfortably report errors and concerns to my Currently, video recording devices are installed
supervisor” (resident). As a result of the training, in Singapore National Eye Centre (SNEC) (see
seniors and juniors openly discussed about barri- Fig. 24.2a) and in many ophthalmic surgical
ers during the TRM session. Many of them were microscopes around the world. All intraocular
related to the lack of psychological safety and the surgeries are video recorded and reviewed
role of hierarchy [61]. whenever deemed necessary from surgical com-
plication or education perspective. However, the
use of the images is often limited to the retro-
Social Orientation spective ad hoc tracking of interesting cases for
teaching or conference and the systematic anal-
During the video feedback programme, the risks ysis of data is often lacking due to intensive
of the mono-disciplinary focus (both between manual work required in retracing the relevant
ophthalmologists and anaesthesiologists and information.
between physicians and other groups) and their A handheld video camera in the OR is, how-
own rules and behaviour were clearly demon- ever, is still far removed from aviation’s black box
strated. An ophthalmologist spoke about the dif- standard. We developed an ongoing Automatic
ferent worlds of surgery and anaesthesia: Digital Operating Room Assistant (ADORA)
Fig. 24.2 (a) Video recording at the operating room of the case hospital (photo: SNEC). (b) Integrating picture-in-
picture video imaging from microscope and overview (stills: SNEC)
project that targets to develop an integrated device manual work is time consuming and can be
to improve operating room (OR) safety and effi- affected by human bias [66, 67]. While micro-
ciency. The system uses automated computer- scopic video images can be used to assess surgical
assisted recognition of surgical technical performance, images from the overview camera in
performance based on microscopic video images the OR can be used to assess non-technical and
of cataract surgeries. It does this to assist in objec- efficiency aspects within the OR. See Fig. 24.2b.
tive structured assessment of cataract surgical Innovative integrated analyses of views of the
skills and to assess the relationship with non-tech- microscope and the OR overview can support
nical findings in OR patterns and teamwork based analysis of the relationship between the surgical
on OR overview video images [64–66]. skills and the non-technical factors in the context
Video images provide actionable information of the OR (Fig. 24.3) [53, 67]. Application of
that can be processed by image-based analysis these insights will result in better and more effi-
techniques. Automation of the data extraction pro- cient training of surgical trainees and optimize
cess is potentially greatly advantageous because the outcomes of all (human) activities in the OR.
Fig. 24.3 Examples of microscope (A1, A2), OR overview gery (source: SNEC OT). (c) Final ‘time out’ team check on
(B1), and integrated video images for automated assessment correct patient ID, eye, procedure, and instruments before
of cataract surgery performance. (a) Phacoemulsification: surgery starts (source: SNEC OT). (d) Comparative analysis
use and movements during cracking of the nucleus (phase of two-layer video images from microscope and overview:
8–11) (source: SNEC OT). (b) Posterior capsule rupture, OT-door opening and staff movement during lens insertion
one of the most occurring complications during cataract sur- (phase 13) (source: SNEC OT)
reliminary Results in Cataract

P case notes indicate a 100 % time-out involvement
Surgery and acknowledgement by surgeon, anaesthetist,
and scrub nurse (Fig. 24.4a), according to the
Preliminary results of our pilot study conducted protocol requirements, while actual observations
in fifteen cataract sessions, that combine an over- using the ADORA system show that verbal
view, a microscopic image and audio data, dem- acknowledgement of the time out by anaesthetist
onstrated variation wide execution of the surgical was clear in only 27 % of the cases, for scrub
time-out procedure as well as in communication nurse in 53 % of the cases, and for surgeons in
between the staff. Audits of checklist in the paper 73 % of the cases (Fig. 24.4b).
Verbal acknowledgement of time-out?

(prelim data from n=15 surgical sessions)
100% 0%
7%
13% 13% 13%
90%
no, not
80% 13% audible
0% 27% 40%
70%
40%
73% uncertain
60%
7%
0%
50% 100%
0%
40% 2=yes, but
73% not clear
30%
53% 53% 0%
47% 1=yes, clear
20%
27%
10%
0%
resident surgeon scrub nurse circulator anest assistant anesthesist
nurse
Fig. 24.4 Comparing notes in patient records to ADORA observations. (a) Intra-operative nursing records suggest
100 % time-out compliance. (b) ADORA observations on verbal acknowledgement of time out
The ADORA stimulated discussion on who of the OT stakeholders, in particular the scrub
initiates the time out, how it is performed, and nurses. In the longer term, we plan to integrate the
who should be involved. The video observations findings into algorithms that would be able to auto-
showed that in one surgical session the time out matically identify the human activities and relate
was initiated by different circulating nurses as them to potential triggers. Besides the time-out
well as the anaesthesia nurse. See Fig. 24.5. compliance and door openings, the system detec-
As a result the exact execution was reempha- tors can also be related to noise, temperature, and
sized and standardized. As a large area of the OT is other technical distractors. Intelligent fusion with
captured in the ADORA system, we were also able the microsurgical views and segmentation of the
to do a detailed analysis on door openings as ear- phase of surgical could lead to a quantifiable score
lier literature suggests a close connection between that is computed by the ADORA system.
door openings and OR infections [68–70]. During
an average 14.5 min of cataract surgical process,
the doors were opened seven times, with an aver- Computer-Assisted Surgical
age opening time of 19 (±3.5) s (see Fig. 24.6). Systems
This suggests that the door is open during 16 % of
the surgical (knife in–knife out) time. In one of the Computer-assisted surgical (CAS) systems using
observed cases, the ADORA system showed that video imaging technology are being increasingly
the new intraocular lens (IOL) was inserted just at developed, aiming at understanding the current
the time when the door was open. situation and possessing the capability of auto-
As the preliminary findings are promising, we matically adapting the assistance functions
are currently working on the study of a larger set-up appropriately [71]. Being able to automatically
that includes analysis of the situational awareness extract information on surgical phases, times
Who initiates for ‘time out’?
Surgical staff Circulating staff Anesthesia staff

Session Surgery surgeon scrubnurse resident circulator1 circulator2 circulator3 anesthetsist anest nurse
1 1 S1 N1 C1 A1 AN1
am 2 S1 N1 C1 C8 A1 AN1
3 S1 N2 C1 C2 A1 AN1
4 S1 N2 C1 C2 A1 AN1
5 S1 N3 C2 C8 A1 AN1
2 6 S2 N5 C3 A2 AN1
am 7 S2 N6 C4 A2 AN1
8 S2 N7 C5 C8 C4 A2 AN1
9 S2 N6 C6 C8 C7 A2 AN1
10 S2 N7 C5 C8 A2 AN1
3 11 S3 N6 R1 C7 A3 AN1
pm 12 S3 N7 R1 C5 A3 AN1
13 S3 N6 C7 A3 AN1
14 S3 N7 C5 A3 AN1
15 S3 N8 C5 C7 A3 AN1
Fig. 24.5 Overview of different staff types initiating and involved in time out
OR door openings during surgery
light light
off on
surgical progress
(minutes) 0.00 4.49 6.54 7.51 9.38 10.5 12.52 13.59 14.50
door open
25 19 15 16 23 19 18
(seconds)
nos door open:7 IOL

average time open: 19s [+/-3.5] insert
16% of surgical time
Fig. 24.6 OR door openings during surgery
frames, and events would facilitate proactive action vs. information coordination behaviour)
management of the OR processes and further will be assessed based on operating room over-
enables for a structured evaluation of the (varia- view images. After comparison and analysis of
tion in) surgical performance. the activities between new surgeons and expert
There are two video sources for the ADORA surgeons, a quantifiable score for teamwork eval-
system (microscope videos and OR overview uation is computed by ADORA system. Finally,
videos). See Fig. 24.7. For microscope videos, the outcomes of surgical performance evaluation
the first step would be to develop an algorithm to and teamwork evaluation will be compared and
automatically identify the main surgical patterns integrated based on intelligent fusion algorithms.
in a video that are deemed to be inevitably part of This will enable to determine the relation between
the surgical procedure. Once the patterns are technical and non-technical factors that influence
identified, they are assigned labels, e.g. drap- surgical performance in the operating room.
ing—surgical field clear of lashes, lens insertion, Existing systems focus on “live showings” of
adjustment of position, etc. These labels are then high-quality images, not on recording and meta-
integrated into a video signature, which is essen- analysis of historic data. We however propose to
tially a succinct yet complete representation of use real surgical data instead of simulated or oth-
the video. The signatures of videos from trainee/ erwise biased. While simulation for new sur-
new surgeons and expert surgeons are then com- geons can be successful, in our approach
pared and a measure of similarity is derived to surgeons do not need to go through time-con-
determine the quality of trainee surgeons. These suming and expensive simulation sessions. In
measures could be in the form of some ‘distance’ the proposed project, we will create ‘big data’
between signatures, which could then be trans- through the recording of all cases and details
lated into a quantifiable score for surgical perfor- instead of “sample selection for assessment”.
mance evaluation [72]. For OR overview videos, The unique marriage of microscope and over-
the earlier similar algorithm would be applied to view images will create a unique toolbox that is
automatically identify the human activities in the valuable for every hospital. The automatic
OR, in which teamwork (e.g. explicit vs. implicit, assessment and recognition of surgical phases is
Fig. 24.7 Layout of the Automated Digital Operating Room Assistant (ADORA)
very useful for situational and context awareness While simulation for new surgeons can be
of surgeons and surgical staff. The use of (micro- successful, in our approach surgeons might not
scope) videos allows automating the surgeons’ need to go through time-consuming and expen-
assistance without altering the surgical routine sive simulation sessions as with ADORA we may
which will reduce teaching time [73, 74]. be able to create ‘big data’ through the recording
These systems might also support intra- of all cases and details instead of “sample selec-
operative decision-making by comparing situation for assessment” [75]. The unique marriage
tions with previously recorded or known of microscope and overview images will poten-
situations. This would result in a better sequence tially create a unique toolbox that is valuable for
of activities and improved anticipation of possible every hospital and supposed to make cataract sur-
adverse events, which would, on the one hand gical training more standardized and give
optimize surgery, and on the other hand improve resident-surgeons objective feedback on their
patient safety. These systems have the promise to performance. Ultimately it could proactively
reduce complications that potentially result in identify unexpected variation and thereby
blindness or reduced visual acuity. The regular improve communication, teamwork, and effi-
day-to-day data obtained from the numerous cata- ciency in the operating room.
ract surgeries performed at the SNEC can be cat- Aviation has not become a safe industry just
egorized into the ideal, good, and unsafe surgery due to well-willing and transparency oriented
and used by the new software written to assess to pilots. Governmental bodies, like national trans-
what extent each surgical procedure deviates from portation and safety boards played an important
the ideal or normal safe surgery at the 12 pre- role. Sector-wide systems approaches are needed.
identified crucial steps in cataract surgery. If black boxes have proven to be invaluable in
improving safety in aviation, could not black reveals many different influencing factors. Trisha
boxes prove to be invaluable to ensuring safety in Greenhalgh et al. [14] have conceptualized these
the operating room? ideas in their model for ‘Diffusion of innovations
in health service organizations’, based on many
examples and a large literature review, a model
Recommendations 4
for the spread and sustainability of innovations in
service delivery and organization. They showed
Safety and Quality Improvement that diffusion is dependent on the characteristics
in the Operating Theatre Are Not of the innovation itself (and its resource system)
Single Treatment Interventions as well as the ‘user system’ (with system anteced-
But Require Complex Socio-technical ents and readiness for innovation, the adopter,
Interventions to Succeed in Sustained assimilation, the implementation process) and its
Improvement links to the outer context (socio-political climate,
incentives and mandates, interorganizational
The design and the video feedback case studies norm setting and networks).
demonstrate that many aspects of improvement The ‘user system’ is one of the most striking
are related to organizational aspects outside the differences between industrial settings and hospi-
scope of the team, like the autonomous position tal care. The most important resources (physi-
of self-employed medical specialists. Catchpole cians) are often not a formal part of the
et al. [77] measured the effect of aviation-style organization that acts as a threshold for the diffu-
team training on three surgical teams from differ- sion of changes. In our first case study, physicians
ent specialties. They concluded that aviation- cooperate in partnership with the hospital, giving
style teamwork training can increase compliance it few opportunities to require physician involve-
and team performance but that “the effect was ment in quality and safety initiatives. The lack of
reduced by significant latent failures in organiza- physician involvement and thus ability to make
tional and personal management factors such as sense of these changes greatly limits uptake,
the attitude and collaboration of key individuals”. spread, and sustained engagement [79]. The indi-
Safety training is not always translated into sus- vidual, independent physician can have limited
tained improvement in day-to-day care delivery. affinity with a hospital’s ‘performance system’
Assessing the organizational and social contexts perspective. Comparative studies of hospital per-
in which interventions are successful, rather than formance where medical staff are employed by
trying to apply strict and artificial controls, is the hospital are, however, scarce [80]. There is no
thus important to providing widely generalizable evidence for systematic differences in quality of
safety and quality improvement [78]. care between self-employed or hospital-employed
physicians [81, 82] but it is known that financial
incentives could influence it. Fee- for-
service
Diffusion and Learning physicians operate at higher volumes than hospi-
in Professional Organizations tal-employed physicians [81, 83, 84]. In Dutch
general hospitals, even when all were lump-sum
The fact that hospitals are professional organiza- reimbursed, salaried medical specialists spent
tions seems to have implications for how they dif- relatively less time on direct patient care and
fuse innovations. The diffusion of innovations in more time on organizational issues [85]. And a
hospitals takes often more time, requires a longer popular European comparison showed that
term perspective than in other industries, and countries where all doctors are hospital- (or gov-
ernment-) employed, such as Denmark and the
4
Part of these recommendations have been described in U.K., have lower performance scores than the
ref. [76]. Netherlands [86].
ealth Care Teamwork Is Work

H Learning from Others
in Progress
The application of quality and safety methods from
Health care professionals seem to have a differ- other industries can stimulate double-loop learning
ent view on teamwork than peers in other indus- [92]. The results of the video feedback programme
tries. Sexton et al. [87] compared safety attitudes demonstrated that ophthalmologists and other hos-
in aviation and hospitals, finding differences in pital staff had become increasingly aware of safety
team perception. The majority of (resident) sur- issues. The multidisciplinary approach promoted
geons had high scores on cooperation; anaesthe- social (team) orientation and thus learning.
siologists’ and (surgical) nurses’ views were Professionals are disposed to focus on their own
much lower. Surgical consultants agreed more world. Mirroring other industries stimulates critical
often than pilots to statements such as “Even views on one’s own work and simultaneously
when fatigued, I perform effectively during criti- catalyses the diffusion of innovations.
cal times” (60 % vs. 26 %) and “My decision- We showed that design approaches are relevant
making ability is as good in medical emergencies to improve safety behaviour in ORs. The findings
as in routine situations” (76 % vs. 64 %). Despite are also relevant for other hospital units: Birnbach
the surgeons’ disavowal, stressors can have a neg- et al. [93] showed in a small but controlled study
ative effect on surgical performance. that the location of the hand rub dispenser (imme-
How organizational learning takes place in diately adjacent to the patient and clearly visible to
health care is very much influenced by the organi- anyone facing the patient’s bed) increased compli-
zational culture and by the position of the physi- ance with hand washing. Lowe [94] showed the
cians, and the relation between caregivers and contribution of latent conditions to patient safety
others [88]. As shown in the case studies team- in the design of ORs and other hospital areas, find-
work and integration of the sensomotor and non- ing that 27 % of all medical devices were designed
technical issues are important for quality and without adequately addressing human factors
safety improvements in health care; learning issues. Grout [29] argues for ‘mistake proofing’ by
should be a collective process. Strong medical changing designs to make processes more reliable
competences in combination with non-technical and effective. Safety and quality approaches in
skills and teamwork are highly important for effec- hospital care, therefore, should include a human
tive work, productive relations, and realizing orga- factors approach that focuses on system design in
nizational improvements in high-reliability bodies addition to teaching clinical and non-technical
such as hospitals [89, 90]. Highly educated profes- skills [95].
sionals are usually excellent in individual and sin-
gle loop learning: they have had to learn to define
and solve problems by themselves. Since they are Conclusions
good at their jobs, however, they rarely experience
failure and usually react defensively or blame Human factor engineering and design thinking
others when something goes wrong [89].
are useful approaches to improve safety, quality,
Acknowledging and identifying failures is, how- and value in the operating room. Operating room
ever, necessary for ‘double-loop learning’, which (OR) design facilitates and stimulates safety
occurs when error is detected and corrected in awareness and resulted in significantly increased
ways that involve modifying the organization’s compliance with the safety procedures [96]. We
underlying norms, policies, and objectives [91]. demonstrated that simple and inexpensive
As observed in the case studies, there can be a dif- changes in design can improve safety and reduce
ference between individual and collective learning undesirable variation. Safety improvement
in teams. approaches, therefore, should focus on ‘mistake
proof’ designs in addition to human factors and 13. Rogers EM. Diffusion of innovations. New York:

Free Press; 1995.
skills training. Moreover, team exchange and
14. Greenhalgh T, et al. Diffusion of innovations in health
benchmarking with other high-risk industries is services organisations: a systematic literature review.
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the identification of practical safety improve- 15. Cassin B, Barach P. Making sense of root cause

analysis investigations of surgery-related adverse
ments. Video feedback of OR processes and team
events. Surg Clin North Am. 2012;92(1):101–15.
behaviour can generate strong data to show varia- doi:10.1016/j.suc.2011.12.008.
tion and stimulate for improvement. Advanced 16. Haynes AB, et al. A surgical safety checklist to reduce
technology and computer-assisted systems could morbidity and mortality in a global population. N
Engl J Med. 2010;360:12–21.
be useful to support automated analysis of video
17. Langelaan M, et al. Monitor health care related harm
streaming and enable proactive managing of the in Dutch hospitals 2008 [in Dutch]. Utrecht: Nivel;
surgical workflow. 2010.
18. Leape L, et al. Transforming healthcare: a safety

imperative. Qual Saf Health Care. 2009;18:424–8.
19. Mangram AJ, et al. Guideline for prevention of sur-
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Diagnostic Error in Surgery
and Surgical Services 25
Mark L. Graber, Juan A. Sanchez, and Paul Barach
“You’re on the Island of Conclusions.”

“But how did we get here?” asked Milo.
“You jumped, of course,” explained Canby. “That’s the way most everyone gets here. It’s
really quite simple: every time you decide something without having a good reason, you
jump to Conclusions whether you like it or not. It’s such an easy trip to make that I’ve
been here hundreds of times.”
“But this is such an unpleasant looking place,” Milo remarked.
“Yes, that’s true,” admitted Canby; “it does look much better from a distance.”
—From The Phantom Tollbooth, by Norton Juster
growing awareness about the importance of diag-

Introduction nostic error in general and the recently issued
report from the Institute of Medicine on Improving
The surgical environment contains abundant
Diagnosis in Health Care [1], it is appropriate to
opportunities for adverse events, and patients
consider what is known about diagnostic error in
under surgical care are at risk for harm. The moni-
surgery, while acknowledging that the vast major-
toring of surgical safety has focused almost exclu-
ity of knowledge in this domain has evolved from
sively on treatment-related concerns, especially
internal medicine and emergency medicine.
on complications of surgery. Diagnostic errors
There are currently four definitions of diag-
have received little attention. Coincident with the
nostic error (Table 25.1) [5], some of which are
based on diagnosis as the noun (the label we give
to an illness), some of which are based on diag-
M.L. Graber, MD (*)
Society to Improve Diagnosis in Medicine, RTI nosis as the verb (the process of arriving at the
International, 5 Hitching Post, Plymouth, label), and the most recent, IOM definition, “The
MA 02360, USA failure to establish an accurate and timely expla-
e-mail: [email protected] nation of the patient’s health problem(s) or to
J.A. Sanchez, MD, MPA communicate that explanation to the patient,”
Department of Surgery, Ascension Saint Agnes which involves both. These definitions are com-
Hospital, Armstrong Institute for Patient Safety
& Quality, Johns Hopkins University School of plementary, and the choice of which one to use
Medicine Baltimore, MD, USA depends on the purpose and the audience being
e-mail: [email protected] addressed. There are no specific definitions of
P. Barach, BSc, MD, MPH, Maj (ret.) diagnostic errors in surgery, but in the surgical
Clinical Professor, Children’s Cardiomyopathy context the concept of diagnosis extends to all of
Foundation and Kyle John Rymiszewski Research the decisions and choices made before, during,
Wayne State University School of Medicine, 5057 and after surgery. These all involve clinical rea-
Woodward Avenue, Suite 13001, Detroit, soning, and will all entail a risk of error.
MI 48202, USA The IOM report provides a comprehensive
e-mail: [email protected] review of diagnostic error that summarizes the

398 M.L. Graber et al.
Table 25.1 Four definitions of diagnostic error

Box 25.1. A case study of diagnostic error in Definitions of diagnostic error
surgery [1] Author Definition
Pat, a 43-year-old male in good health, Mark Medical diagnoses that are wrong,
experienced progressively severe neck Graber missed, or delayed [2]
pain, and a scan showed a mass on his cer- A diagnosis that was unintentionally
delayed (sufficient information was
vical spine. While removing the mass, the available earlier), wrong (another
neurosurgeon sent a tissue sample to a hos- diagnosis was made before the correct
pital pathologist, who examined the sample one), or missed (no diagnosis was ever
and called back to the operating room to made), as judged from the eventual
appreciation of more definitive
report that it was an atypical spindle cell information (LABEL)
neoplasm. Assuming that this meant a Hardeep A breakdown in the diagnostic process
benign mass, the surgical team completed Singh and a missed opportunity to have made
the operation and declared Pat cured. the diagnosis more accurately or more
Following the operation, however, the hos- efficiently…regardless of whether there
was patient harm [3] (PROCESS)
pital pathologist performed additional
Gordon Any mistake or failure in the diagnostic
stains and examinations of Pat’s tissue, Schiff process leading to a misdiagnosis, a
eventually determining that the tumor was et al. missed diagnosis, or a delayed diagnosis.
actually a malignant synovial cell sarcoma. This could include any failure in timely
Twenty-one days after the surgery, the access to care; elicitation or
interpretation of symptoms, signs, or
pathologist’s final report of a malignant laboratory results; formulation and
tumor was sent to the neurosurgeon’s weighing of differential diagnosis; and
office, but it was somehow lost, misplaced, timely follow-up and specialty referral or
or filed without the neurosurgeon seeing it. evaluation [4] (PROCESS)
The revised diagnosis of malignancy was Institute of The failure to establish an accurate and
Medicine timely explanation of the patient’s health
not communicated to Pat or to his referring problem(s) or to communicate that
clinician. Six months later, when his neck explanation to the patient [1] (LABEL
pain recurred, Pat returned to his neurosur- AND PROCESS)
geon. A scan revealed a recurrent mass that
had invaded his spinal column. This mass using the structure-process-outcome model of
was removed and diagnosed to be a recur- Avedis Donabedian, is that healthcare organiza-
rent invasive malignant synovial cell sar- tions and departments of surgery are familiar
coma. Despite seven additional operations with process improvement, opening the door for
and numerous rounds of chemotherapy and applying these same approaches to improving
radiation, Pat died 2 years later at age 45 surgical diagnosis and outcomes [6]. Many “sur-
years with a 4-year-old daughter and a gical” errors involve the very first step—timely
6-year-old son. access to surgical care. Delays in referring
patients who could benefit from surgical evalua-
tion and interventions are common in many con-
available literature through 2015 and presents a ditions, ranging from cataracts to cancer-related
series of eight recommendations for improving surgery to aortic dissection, to name a few. For
diagnostic performance [1]. In addition to pro- some conditions, these delays can be cata-
viding the new definition of error, the report pro- strophic: in aortic dissection, delays between
vides a helpful framework for understanding and presentation and diagnosis and, once diagnosed,
discussing the diagnostic process (Fig. 25.1). definitive treatment leads to dramatic increase in
The power of describing diagnosis as a process, adverse outcomes [7].
25 Diagnostic Error in Surgery and Surgical Services 399
Fig. 25.1 The dual process

paradigm of decision-making.
Modified from Ref. [1]
leading categories [11]. Most of these cases

he Incidence of Diagnostic Error
T involved patients with cancer, cardiovascular
in Surgery conditions, and various injuries, especially ortho-
pedic injuries. In another study, of 7438 closed
Diagnostic errors are extremely common; one in claims from 2007 to 2013, 1877 were attributed
every ten diagnoses is probably wrong [8]. to diagnostic error [12]. Of the 3963 claims
Fortunately, the vast majority of diagnostic errors involving surgeons, 524 were related to issues in
are inconsequential; the original problem diagnosis. The top five claims in each specialty
resolves, the error is caught in time, the patient is are noted in Table 25.2.
resilient, or the treatment that was provided While data from filed claims can help determine
worked anyway. For some fraction of patients, the relative distribution of surgery-related cases,
however, the error results in harm and death. One the true incidence of diagnostic error in surgery is
estimate places the annual toll of diagnostic error not known because the number of cases with good
in the USA at 40,000–80,000 deaths per year [9]. outcomes is large and not precisely known. A simi-
When timely surgical intervention is critical, lar situation is encountered in internal medicine
misdiagnosing conditions such as spinal cord and emergency medicine—the actual incidence of
compression, necrotizing fasciitis, acute myocar- diagnostic error is not known, and at the present
dial infarction, among many others, is lethal. The time, no organizations report rates of diagnostic
decision whether to operate on patients in whom errors [13, 14]. This reflects primarily the difficulty
these diagnoses are being considered is also a in identifying diagnostic errors, but also the chal-
diagnostic decision, and the pressure and angst lenges physicians encounter in coming to an agree-
inherent in these situations is substantial and ment on what comprises an error, as opposed to the
undeniable [10]. normal evolution of a diagnosis over time, or the
Data compiled from malpractice claims have normal variability from one physician to another in
clarified the relative incidence of surgical errors diagnostic evaluation. Although healthcare has
and what conditions are most commonly encoun- focused on patient safety for almost two decades,
tered. Diagnostic errors are the number one or diagnostic errors have received relatively little
two categories of claims in all of these studies. attention. This has reflected cultural attitudes dis-
More than half of the diagnostic errors originate couraging discussion of misdiagnosis, the chal-
in ambulatory settings. In one recent study of lenges in finding and defining these errors, assump-
2531 cases of diagnostic error in ambulatory set- tions about the impracticality of potential process
tings, 17 % were surgery related, with orthope- or outcome measures of diagnostic quality, and the
dics, urology, and general surgery being the belief that diagnostic errors are less amenable than
Table 25.2 The most common conditions leading to claims involving diagnostic error [12]
General surgery claims (855) Gynecological claims (674)
16 % Diagnosis-related (143) 15 % Diagnosis-related (98)
15.4 % Puncture/laceration during procedure 21.4 % Breast CA
9.8 % Breast CA 12.2 % Puncture/laceration during procedure
8.4 % Post-op infection 9.2 % Uterine CA
6.3 % Colorectal CA 7.1 % Cervical CA
4.2 % Appendicitis 5.1 % Ectopic pregnancy
Orthopedic claims (1647) Obstetrics claims (757)
13 % Diagnosis-related (215) 9 % Diagnosis-related
11.2 % Post-op infections 17.6 % Ectopic pregnancy
5.6 % Bone/soft tissue CA 7.4 % Postpartum hemorrhage
4.2 % Compartment syndrome 4.4 % Puncture/laceration during procedure
3.3 % Fracture malunion 4.4 % Appendicitis
2.3 % Pulmonary embolism 2.9 % Pulmonary embolism
Table 25.3 Examples of case studies of specific surgical

other types of medical errors to systems-level solu-
conditions and their findings relating to diagnostic accu-
tions [15, 16]. racy and timeliness
Although real-time data is lacking, there is a
Appendicitis Graff et al. Retrospective study
wealth of research data that suggests diagnostic (2000) [21] at 12 hospitals. Of
errors are quite common [8]. In internal medi- 1026 patients who
cine, one in every ten diagnoses is believed to had surgery for
suspected
be wrong, based primarily on studies involving
appendicitis, 110
standardized patients with classic presentations patients had no
in real-world settings. A recent study using appendicitis at
chart reviews found that one in every 20 ambu- surgery; Of 916
patients with a
latory care patients will experience a diagnostic
diagnosis of
error every year [17]. Autopsy studies consis- appendicitis, the
tently show major discrepancy rates (discrepan- diagnosis was
cies with a high likelihood to have changed missed or wrong in
170 (18.6 %)
management and treatment) in the range of
Subarachnoid Kowalski Of 482 patients
10–30 % [18, 19]. In programs providing sec- hemorrhage et al. (2004) with subarrachnoid
ond opinions, the likely diagnosis changes for [22] hemorrhage, the
one in seven patients, and treatment recommen- diagnosis was
dations change for one in three patients [20]. initially wrong in
56 (12 %) and 22 of
The surgical specialties differ greatly, however, these patients
in how often the second opinion differs from suffered
the first. In terms of treatment recommenda- neurological
tions, changes are less frequent in surgical complications
before the diagnosis
oncology (19 %) and urology (28 %), and are was confirmed
more frequent in neurosurgery (42 %) and Edlow Review of
obstetrics (42 %) [20]. Finally, retrospective (2005) [23] published studies:
collections of cases are available for many con- approximately
ditions, and invariably report either bad or 30 % are
misdiagnosed at
shocking statistics on diagnostic accuracy and presentation
timeliness. Several examples relevant to surgi-
cal care are listed in Table 25.3. (continued)
Table 25.3 (continued) Table 25.3 (continued)

Ruptured aortic von In patients Tongue cancer Kantola et al. Of 75 cases,
aneurysm Kodolitsch presenting with (2001) [31] referral to specialty
et al. [24] chest pain due to care was delayed in
dissections of the 35 %
proximal aorta, the Cancer-related Levack et al. Of 319 patients, the
diagnosis was spinal cord (2002) [32] median delay in
missed in 35 % compression diagnosis was 18
Lederle et al. Review of all cases days
(1994) [25] at a single medical Bone cancer Goyal et al. Of 103 patients
center over a (2004) [33] with osteosarcoma
7-year period. Of or Ewing’s
23 abdominal sarcoma, delayed
aortic dissections, diagnosis was
the diagnosis was associated with
initially missed in being seen by a
14 (61 %) general practitioner
Gastric cancer Mikulin and Of 83 patients with (vs. ER physician)
Hardcastle gastric cancer, the and in patients
[26] median delay in under 12 years of
diagnosis was 7 age
weeks Testicular Vasudev Of 180 men with
Oral Cancer Schnetler Of 96 cases seen in cancer et al. (2004) testicular cancer,
[27] three oral surgery [34] referral to specialty
departments, the care was delayed in
referring general 60 %
practitioner had
made the correct
diagnosis in only
52 %
Breast cancer Beam et al. 50 accredited he Etiology of Diagnostic Error
T
(1996) [28] centers reviewed in Surgery
blinded
mammograms of
79 women, 45 of Diagnostic errors in surgical patients evolve from
whom had breast the same set of cognitive- and system-related fac-
cancer. The tors as in other clinical settings. A very small
diagnosis would
have been missed
fraction of errors derives from patient-related
in 21 % factors, for example patients with Munchausen’s
Cancer Burton et al. Autopsy study at a syndrome who feign symptoms [35], or patients
detection (1998) [29] single hospital: Of who choose not to undergo diagnostic tests that
250 malignancies, were recommended or attend follow-up appoint-
111 were either
missed or ments. Most errors, however, reflect shortcom-
misdiagnosed, and ings of the clinician’s cognitive processes, in the
in 57 cases the face of one or more breakdowns in the systems of
cause of death was care [2].
cancer related
Cognitive errors involve one of three problems:
Breast cancer Burgess et al. Of 132 patients
(1998) [30] with breast cancer,
referral for 1. A knowledge deficit. For example, the physi-
definitive cian does not know or recognize the disease at
management was hand. There are over 8000 diseases listed in
delayed in 32
(17 %) the National Library of Medicine’s MESH
catalogue, and over 100 new diseases are
(continued)
entered every year.
2. A problem collecting or interpreting diagnos- actions and thoughts derive from this system. In
tic data. For example, the physician fails to practice, both systems may come into play in diag-
appreciate the auscultatory findings of a pneu- nosing a new patient problem, and in theory, the
mothorax, or doesn’t recognize that a patient’s rational system has the opportunity and responsi-
hyperkalemia is from hemolysis, noted at the bility to be constantly monitoring intuitive process-
bottom of the laboratory slip. ing. If some discrepancy is noted or something just
3. An error in “putting it all together,” synthesiz- “doesn’t fit,” the rational pathway takes over and
ing the facts at hand with the physician’s we sense the need to slow down, or look for addi-
knowledge base to arrive at the correct diag- tional data or input to affirm our hunches or heuris-
nosis or differential diagnosis. This is the pro- tics. If there are no such flags, we assume our
cess of clinical reasoning. assessment is correct and proceed. Unfortunately,
the “feeling of right” in these situations is exactly
There is no data on the relative frequency of the same whether our diagnosis is correct or not,
these error types in surgery, but in internal medi- until that unpleasant point that we realize that the
cine, the vast majority of cognitive errors are in the diagnosis may be wrong [37]. Physicians, like all
third category, which entails synthesizing the avail- decision-makers, are generally not accurate in pre-
able information [2]. The current paradigm of clini- dicting which of our diagnoses are correct or not, a
cal reasoning involves the use of two very different problem of calibration [38–40].
cognitive pathways [36] (Fig. 25.2). Except for Both systems are error prone but for different
early trainees, most new problems are recognized reasons. The rational pathway for understanding
immediately, and using a subconscious, intuitive a clinical dilemma in surgery can be degraded by
pathway, the diagnosis is evident within millisec- insufficient knowledge or experience, or by flaws
onds. If the problem is not recognized, we resort to in logical thinking, or reasoning. Intuitive
deliberate, rational consideration of the situation, a decision-making can be degraded by a large
process that takes longer and involves cognitive range of innate cognitive “biases,” of which over
“work.” Humans and probably all animals have 150 have been described, (See Wikepedia’s ever
evolved to take advantage of the intuitive pathway expanding “List of Cognitive Bias”) and com-
whenever we can, and indeed almost all everyday monly encountered examples are shown in
Fig. 25.2 The current dual-process paradigm for “how doctors think”
Table 25.4 Common cognitive biases associated with diagnostic error

Common cognitive biases in medical diagnosis
Cognitive bias Definition Predisposing factors, examples
Premature closure Accepting a diagnosis that “fits” The physician is rushed; failure to
without considering other recognize two conditions
possibilities happening at once (e.g., second or
third fractures after identifying
the first one)
Representativeness bias Missing the correct diagnosis Atypical presentations: an elderly
because of excessive reliance on the woman with fatigue and shortness
presence/absence of classic of breath but no chest pain is not
characteristics worked up for MI
Availability bias Judging a diagnosis to be more A patient with vomiting and fever
likely if it readily comes to mind, from gangrenous bowel is
particularly because of recent diagnosed with gastrointestinal
experience flu because it is “going around”
Framing error Accepting a diagnosis suggested by Referrals, handoffs. The
the patient or another MD consulting surgeon may too easily
accept the diagnostic impression
of the ER physician who first sees
the patient
Context errors Misunderstanding the true context of A patient with vomiting and fever
the problem at hand, a failure of is assumed to have a GI problem,
sense-making but the real issue is sepsis and
diabetic ketoacidosis
Affective bias Negative or positive emotions and Positive—we fail to consider a
feelings that subconsciously detract more serious diagnosis in
from optimal decision-making someone we are close to or
admire or identify with
Negative—we fail to investigate
further in a patient who we
subjectively dislike
Table 25.4 [41]. The IOM report emphasized the from a different perspective. Secondly, the large
importance of the environment and the work sys- amount of task-oriented activities surrounding
tem in determining the quality and outcome of preoperative preparation and the mental rehearsal
diagnosis and clinical decisions. The local cul- a surgeon or anesthesiologist must go through
ture of safety is critical, along with human factors may not leave sufficient cognitive capacity to
that can influence the immediate situation, such avoid diagnostic errors or prevent biases [42]. It is
as stress, distractions, fatigue, and team support. generally acknowledged that cognitive overload
Surgeons face a number of unique cognitive directs cognition away from the rational, deliber-
challenges that may predispose to diagnostic errors. ate pathway and toward the more error-prone
First, patients undergoing surgery have typically intuitive approach. Finally, surgeons require a
been seen by a number of physicians leading up to high level of confidence to lead a team through
the surgical event, creating the unavoidable assump- high-risk operations, raising the question of
tions that all of the requisite diagnostic thinking has whether this may sometimes engender overconfi-
already been completed, and that the diagnostic dence and a tendency to disregard other opinions
conclusions can be trusted (see Box 25.2). or novel information. This requires training sur-
Conversely, patients presenting with condi- geons on becoming team leaders and being aware
tions that are considered primarily surgical, such of how these factors can shape their actions and
as patients with an “acute abdomen,” may not be the actions and outcomes of others [43].
seen by other internists or emergency medicine System-related errors that contribute to diag-
staff, thus losing the opportunity to be assessed nostic error include breakdowns in communica-
nostic error, because physicians generally believe

Box 25.2. Cognitive Challenges of that they are practicing at a very high level, and
Diagnostic Error in Surgery tend to attribute diagnostic errors to other clini-
A patient is being evaluated for upper GI cians who aren’t as experienced or careful. All
bleeding in the Emergency Department. humans and, perhaps, physicians in particular are
The patient has a remote history of an overconfident in their abilities and in the correct-
abdominal aortic aneurysm repair and a ness of their clinical decisions [44] The cognitive
more recent history of peptic ulcer disease. errors made in clinical diagnoses are the same
The diagnosis by the patient’s primary care errors people make in their everyday lives; we
provider, the ED staff, and a consulting jump to conclusions, we trust information given
gastroenterologist is a bleeding ulcer. to us without verifying it, we accept an assigned
When the surgeon is called for persisting diagnosis without rethinking it, and our emotions
bleeding and proceeds with plans for an get in the way of good judgment. All physicians
emergency gastrectomy, the assumption is can improve the quality of their practice by
made that the diagnosis is correct. In the accepting the universal predisposition to error,
OR, the patient is found to have an aorto- understanding the causes of diagnostic error, and
enteric fistula and the patient exsanguinates addressing these problems transparently.
on the table before a vascular surgeon can
be called in to assist.
What factors might have contributed to ddressing Interpretive Diagnostic
A
the cognitive errors in this case? Error in Surgical Pathology
and Cytology
• Knowledge by the surgeon about the
prior history of aortic aneurysm repair Optimal surgical diagnosis and care relies heav-
• Deliberation about the speed of the ily on accurate cyto-pathological diagnosis, and
bleeding ulcer diagnosis errors deriving from the interpretation of cytol-
• Cognitive challenges of preparing for ogy, biopsy, or surgical specimens are important
the technical aspects of the procedure to recognize and address. Errors may arise at any
• Accepting a diagnosis without due con- point in the “total testing cycle” [45], which
sideration of other possibilities leading begins with specimen acquisition, labeling, and
to assuming the diagnosis is correct delivery to the laboratory, where the specimen is
prepared for the analytic phase. The post-ana-
lytic phase begins with a report generation and
tion or coordinating care, reliably transmitting ends with delivery of the report to the clinician,
test results and consults, erroneous laboratory or and the clinician acting on it appropriately.
imaging interpretations, difficulties associated Unlike the other phases of the total testing cycle,
with using an electronic health record, supervis- the analytic phase is substantially different in
ing trainees, and a host of other issues [2]. surgical pathology and cytology (vs. clinical
Cognitive load contributions are identified as the pathology and automated lab testing) in that it
lead cause for most cases of diagnostic error [2]. involves visual interpretation and the judgment
of the pathologist to arrive at the correct inter-
pretation [33, 46, 47]. Compared to automated
ddressing Diagnostic Error
A lab testing, which operates at error rates in the
in Surgery range of 0.01–0.001 %, the error rate in surgical
pathology is orders of magnitude higher, in the
As the old saying goes, the first step in addressing range of 2–5 % [34, 48, 49]. Errors in the post-
any problem is recognizing that you have one. analytical phases of testing are also especially
This is particularly relevant in the case of diag- common [50, 51], and many involve failures to
reliably communicate test results [52], as illus- detailed and specific set of guidance on second
trated in the case vignette above. opinions in cancer diagnosis is available in the
There are many factors that contribute to an 11-part series from Cancer Care Ontario [57].
accurate interpretive diagnosis, including: (1) the
pathologist’s knowledge and experience, (2) clin-
ical correlation, (3) standardized diagnostic crite- Addressing Cognitive Errors
ria and taxonomy, (4) confirmatory ancillary
studies when available, and (5) secondary review Experience and meaningful feedback are the car-
of cases. dinal requirements to acquire expertise, and
Studies have shown the additive value of clin- expertise is probably the most important factor in
ical correlation, standardization of diagnostic cri- determining the ultimate quality of the diagnostic
teria, and taxonomy and confirmatory ancillary process. It is generally accepted that experts
testing to the accuracy of surgical pathology and make the fewest errors, possibly because they’ve
cytology diagnoses [53–55]. Several of these fac- made them all before [58, 59]. Think-aloud ver-
tors contribute to establishing a precise diagno- bal protocols, both concurrent and retrospective,
sis, but the pathologist’s knowledge and have been used to reveal the refined knowledge
experience remain the essential factors in inter- and reasoning strategies underpinning superior
pretive diagnosis such as in neuropathology tis- performance [60]. These techniques are useful to
sue ambiguity. Although numerous studies have identify the domain-specific knowledge that
shown that second opinions help detect interpre- experts utilize to perform the task. For example,
tive diagnostic errors [56], there have been only Lesgold et al. reported that expert radiologists
scattered efforts to formalize and adopt this prac- demonstrate longer reasoning chains with more
tice as a clinical standard. Targeted case reviews of their comments being interlinked and inter-
could be an integral component of a quality connected to at least one other chain. These find-
assurance plan that is aimed proactively at pre- ings highlight how experts store and organize
venting errors before they have a potential knowledge in a more coherent manner, enabling
adverse impact on patients. The College of them to better access and retrieve this informa-
American Pathologist has issued a recent guide- tion to solve simple tasks [61].
line on the use of second opinions in surgical Regardless of one’s level of expertise, there
pathology [49], (see Table 25.5) and a much more are several strategies to improve clinical reason-
ing that have good potential to reduce the likeli-
hood of cognitive errors [62, 63]:
Table 25.5 Guidelines College of American Pathologists
Guidelines for Interpretive Diagnostic Error Reduction in 1. Practice Reflectively. Active reflection allows
Surgical Pathology and Cytology [48] clinicians the rational, deliberate pathway to
• Anatomic pathologists should develop procedures review intuitive decisions, opening the door to
for review of pathology cases in order to detect considering alternative ideas or approaches.
disagreements and potential interpretive errors, and
to improve patient care Although both intuitive and rational cognition
• Anatomic pathologists should perform case reviews are error prone, it is widely believed that most
in a timely manner to have a positive impact on diagnostic errors involve the intuitive path-
patient care way, and that these errors can either be
• Anatomic pathologists should have documented avoided, or recognized more reliably by
case review procedures that are relevant to their
reflective practice and knowing the common
practice setting
• Anatomic pathologists should continuously monitor
biases that arise. “De-biasing” refers to formal
and document the results of case review training on the common cognitive error types,
• If pathology case reviews show poor agreement and has been shown to reduce diagnostic
within a defined area, anatomic pathologists should errors in research settings [64–66]. Because
take steps to improve agreement the most common cognitive errors are prema-
ture closure (accepting a diagnosis without the service of a common and valued team goal
due consideration of other possibilities) and [78]. At its core, TeamSTEPPSTM aims to
context-related errors, it is valuable to be as teach four fundamental competencies that
comprehensive as possible in considering dif- constitute teamwork (leadership, situation
ferent diagnostic possibilities. Always con- monitoring, mutual support, and communica-
struct a differential diagnosis. In a recent tion) with the aid of patient scenarios, case
study of diagnostic error, there was no differ- studies, multimedia, and simulation [79, 80].
ential diagnosis listed in 80 % of the cases Individual surgical team members are highly
[67]. “What else can this be?” is the universal specialized and have their own functional
antidote in these situations and that question task-work (e.g., anesthesia, nursing, surgery,
should be commonly asked by both patients and perfusion), yet come together as a team
and their surgeons [68]. towards the common goal of treating the
2 . Work in Teams. The power of the team to patient. Interventions focusing on teamwork
improve decision-making and performance in have shown a relationship with improved
general is well recognized and amply docu- teamwork and safety climate [81]. The “work-
mented [69, 70]. The Institute of Medicine ing together” of a clinical microsystem is
strongly endorsed the recommendation to accomplished by a complex suite of “nontech-
work in teams as a strategy to reduce diagnos- nical skills” coming together to grow the situ-
tic error, and specifically called for patients ational awareness and interconnectedness [82,
and nurses to be consistently and effectively 83]. Teams that score low on independently
included and empowered as team members observed nontechnical skills make more tech-
[1]. The patient can act as a safety net to detect nical errors and in cases where teams infre-
diagnostic errors, and as the party most inti- quently display team behaviors, patients are
mately affected has both the knowledge and more likely to die or experience major com-
the incentive to monitor the diagnostic pro- plications [84]. There is a significant correla-
cess and its outcomes [71, 72]. tion between subjective assessment of
The concept of the surgical team is well teamwork by team members and postopera-
established in the operating room, where team tive morbidity. Good teamwork (in terms of
behaviors have been shown to correlate with both quality and quantity) is associated with
outcomes and complications [73], especially shorter duration of operations, fewer adverse
in cases of high complexity [74]. The leader- events, and lower postoperative morbidity
ship style of the surgeon has received increas- [85].
ing attention as a determinant of surgical 3 . Get Help—Second Opinions. Second opinions
outcomes; surgeons who score poorly in are a particularly effective method of detecting
transformational leadership styles have worse diagnostic errors, and should be encouraged at
outcomes [75], thought to reflect in part a cli- every opportunity. This should begin by
mate in the surgical theater where there is lim- requesting a second review of all important sur-
ited psychological safety for others to speak gical biopsies, whereas, the diagnosis will
up [76]. The “captain of the ship” approach change in a small but important fraction of
discourages members of the team from point- these cases [49, 86]. Interdisciplinary case con-
ing out findings which may be inconsistent ferences and “tumor boards” are the role model
with the presumptive diagnosis out of fear of for effective ways to obtain second opinions
censure [77]. and learn from others in critical manner [87].
Surgical team training, such as using Working in teams is a very effective way to
TeamSTEPPS, teaches the communication obtain second opinions. Second opinions may
and coordination processes that are required be helpful intraoperatively from other surgeons
to bring together the individual knowledge, or other types of specialists in ensuring a cor-
skills, and attitudes of the team members in rect diagnosis or operative decision.
A second key area where second opinions fied several opportunities to close the system-loop-
may be helpful is when the decision to proceed holes that can become the key factors in producing
with elective surgery is being considered. an error [97]. Communication breakdowns are the
Second opinions were once required by insur- most commonly identified problems in cases of
ance carriers; of 4555 patients who partici- diagnostic error, as they are in all other types of
pated in the Cornell Elective Surgery Second adverse events. Surgical care is particularly sus-
Opinion Program, the second surgeon often ceptible to communication challenges, given the
disagreed with the need for elective surgery, large number of players involved in a typical case,
and disagreement was highest in gynecology involving the patient, family members, the refer-
and orthopedic cases [88]. Disagreement, of ring physicians or ER staff, the anesthesiologists,
course, does not imply that the initial decision the surgical team, and pathologists, just to name a
was wrong, as we lack studies with detailed few [98]. Communication breakdowns, for exam-
and long-term follow-up of patients. ple, are almost always cited in cases of wrong-site
An interesting variant of this approach surgery [99], and in patient handoffs where vital
involves the addition of a nurse practitioner to a information is lost or degraded [100].
pediatric trauma service to specifically review The electronic medical record can improve
and follow all cases. Missed injuries in trauma communication if used appropriately, by making
care average 4–5 % [89], and the involvement tests, notes, consults, impressions, and plans
of this second pair of eyes was effective in readable, and accessible. They can also degrade
uncovering many surgical misdiagnosis cases communication to the extent that the team mem-
that would have otherwise been missed [90]. bers no longer interact verbally, as illustrated by
Web-based decision support tools are read- the “Texas Ebola” case where the ER triage nurse
ily available to assist in differential diagnosis knew that the febrile patient in the ER had been
[91–93], but these resources are generally exposed to Ebola, but the treating clinician failed
underutilized by clinicians [94]. Although not to read her note in the electronic record [101].
yet evaluated in surgical settings, these tools Copy-paste notes seriously degrade the reliability
can improve the accuracy of medical diagnosis, of the medical record [102], as do many features
in addition to being an excellent teaching tool that were designed more for billing than to opti-
for trainees. Checklists and “time out” proce- mize clinical care [103, 104]. The case study pre-
dures have proven to be an important aid in sented in this chapter illustrates a communication
regard to surgical safety, and comparable inter- breakdown, the failure of an amended pathology
ventions could be potentially helpful in pre- report to be effectively communicated to the can-
venting diagnostic error by surgeons if used to cer surgeon in a timely manner.
engage surgical providers in meaningful way Other addressable system-related human fac-
[95]. The tertiary trauma survey, for example, tors problems include workload stress, fatigue,
provides a systematized and reproducible and the constant distractions that are common-
approach to the diagnosis of injuries in these place in surgical environments [105, 106].
patients, and can reduce diagnostic errors [89]. Surgical units should also promote a culture of
safety at every opportunity, eliminating blame
and focusing on learning from cases of diagnos-
Addressing System-Related Errors tic error. Encouraging feedback from patients,
autopsies, and clinical follow-up on discharged
All system-related errors are considered prevent- patients back to discharging clinical staff offer
able, and the original IOM report To Err is Human enormous learning opportunities both to validate
concluded that the repair of system-related flaws the accuracy of diagnosis and to unmask process
would be the most effective approach to improving deficiencies. Most training programs, both under-
safety in healthcare [96]. A recent systematic graduate and postgraduate, offer little or no train-
review of system-related diagnostic errors identi- ing on patient safety in general, or diagnostic
error specifically [107]. Lectures, case studies, in the short term. The recent advances in under-
and morbidity/mortality conferences are all standing the system-based and cognitive factors
appropriate vehicles to expose surgical trainees that contribute to these errors are important, and
and students to the basic concepts relevant to they create an opportunity to redesign the training
diagnostic error: Human factors, the cognitive and feedback to surgeons and consider what inter-
psychology of decision-making, practice-based ventions might be helpful [62, 63, 97]. Surgeons
improvement, communication optimization, and surgical programs should be encouraged to
teamwork, and many other topics would provide consider which of these interventions would have
both a foundation and a vocabulary for improv- the greatest impact on improving diagnostic per-
ing the reliability of clinical reasoning in prac- formance in their own situations and participate
tice [108]. in research programs to evaluate the outcomes of
One of the major recommendations in the IOM these projects. Surgical programs should strive
report on Improving Diagnosis in Health Care for patient-centered approaches that incorpo-
was to make the patient an effective partner in the rate the benefits of working in teams, practicing
diagnostic process (see Chaps. 4–13). There is reflectively, taking advantage of second opinions,
growing evidence that engaged patients have bet- and efforts to address the many other system-
ter health outcomes [109]. Involving patients in related and cognitive factors that underlie diag-
decisions on their elective surgery illustrates that nostic errors.
patients welcome being involved in shared deci-
sion-making. An instructive example is a patient-
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Preventing Perioperative ‘Never
Events’ 26
Patricia C. Seifert, Paula R. Graling,
and Juan A. Sanchez
“Errors will be made, but it is from our mistakes, if we pursue them into the open instead
of obscuring them, that we learn the most”
—Harvey Cushing, New England Otological and Laryngological
Society, 1920, 156, p. 210.
1 . Unambiguous: identifiable and measurable.

Introduction 2. Serious: results in significant patient disability
or death.
In 2001, Kenneth Kizer, M.D., the former Chief
3. Usually preventable.
Executive Officer of the National Quality Forum
(NQF), introduced the term ‘Never Event’ to Another consideration that has become
describe an egregious medical error that should increasingly significant in an era of cost con-
never occur (e.g., wrong-site surgery) [1]. The sciousness is that adverse events are expensive.
initial list published by the NQF in 2002 identi- For hospitals and physicians, never events such
fied 27 events. A revision in 2011 regrouped the as surgical site infection and other adverse com-
events into seven categories: surgical, device, plications can result in a reduction of reimburse-
patient protection, environmental, care management from the Centers for Medicare & Medicaid
ment, radiologic, and criminal [2]. Three impor- Services (CMS) and other payers [3–5].
tant characteristics of never events are as Among the never events that have been identi-
follows: fied during the perioperative period by the NQF
[1] and CMS [3]—and are discussed in this chap-
ter—are the following:
P.C. Seifert, RN, MSN, CNOR, FAAN (*) • Misidentification (wrong patient/procedure/
Cardiac Surgery Consultation, site)
6502 Overbrook Street, Falls Church, VA • Medication errors
22043, USA • Pressure ulcers and related positioning never
events
P.R. Graling, DNP, RN, CNOR, FAAN • Surgical site infections
Department of Surgery, Inova Fairfax Medical
Campus, 3300 Gallows Road, Falls Church, VA • Electrical and other energy-related never events
22042, USA • Retained surgical items (formerly known as
e-mail: [email protected] ‘retained foreign bodies’)
J.A. Sanchez, MD, MPA • Device failures and misuse
Department of Surgery, Ascension Saint Agnes • Difficult airway, failed airway, and air embolus
Hospital, Armstrong Institute for Patient Safety & • Surgical specimen errors
Quality, Johns Hopkins University School of Medicine,
Baltimore, MD, USA • Inadvertent hypothermia
e-mail: [email protected] • Instrument care and reprocessing never events

414 P.C. Seifert et al.
These adverse events are similar to the top Commission’s Universal Protocol™ [31]. The
rated safety issues reported in a study [6] of over checklist also mirrors many of the guideline
3000 perioperative nurses working in both hospi- statements from the American College of
tals and ambulatory surgery centers. The consis- Surgeons’ (ACS) Statement on Ensuring Correct
tency of the issues identified as safety risks Patient, Correct Site, and Correct Procedure
among the health professions is reflected in the Surgery [32] as well as information found on the
surgical [7–9], medical [10], anesthesia [11, 12], Anesthesia Patient Safety Foundation’s (APSF)
nursing [13–19], and interprofessional [20–22] website [33].
literature. In particular, interventions to prevent or
The following discussion of never events reduce never events include:
incorporates information from various profes-
sional sources and describes recommendations, • improving communication (e.g., nurses clari-
strategies, and resources that can be employed to fying scheduled procedures with surgeons’
prevent or minimize these adverse events. office staff as well as the attending surgeon),
• complying with policies mandating the use of
checklists (e.g., team members engaging in
isidentification (Wrong Patient/
M time-outs and surgical briefings and
Procedure/Site) debriefings),
• strengthening teamwork (e.g., engaging in
Over 2/3 of the respondents (68.6 %, N = 2151) in simulation exercises to promote interprofes-
the study by Steelman and colleagues ([6], p. 407) sional behaviors), and
identified the prevention of wrong site/procedure/ • training team members to strengthen nontechni-
patient surgery as the highest priority safety issue cal skills (e.g., situational awareness, flexibility,
in both hospitals and ambulatory surgery centers. adaptability, questioning, leadership) [34–37]
Although preventive tools, such as checklists [23]
have been promoted since the 1998 publication of Additional strategies for reducing the risk of
The Joint Commission’s Sentinel Alert [24], mis- wrong patient/procedure/site surgery are listed in
identification never events persist [25]. Table 26.1.
Studies employing checklists have shown
reductions in surgical complications and mortal-
ity [23, 26]; however, errors and adverse events Medication Errors
continue to occur [14]. The World Health
Organization’s (WHO) original [23, 27] checklist According to Grissinger and Dabliz [38],
addresses three phases of surgery: (1) before Steelman and Graling [19], and others [39, 40],
anesthesia induction (briefing), (2) before the major issues related to medication safety include:
skin incision (time-out), and (3) prior to the
patient’s exit from the operating room (OR) • failure to confirm the identity of the patient
(debriefing). Numerous factors, most notably with the right medication ordered for that
communication failures, lack of compliance with patient
policies and procedures, and lack of collabora- • storage of similar-looking and same-sounding
tion and teamwork [7, 28] contribute to the chal- medications in close approximation (e.g.,
lenges associated with avoiding errors during the placed next to one another in a medication
three phases of surgery. storage unit)
The WHO checklist has undergone numerous • absent, incomplete, or inaccurate labeling of
iterations. One notable example developed by the medications on the surgical field (including
Association of periOperative Registered Nurses those transferred into metal or plastic basins—
[29, 30] (AORN) is a surgical checklist (Fig. 26.1 such as heparin solutions or normal saline)
Checklist) that incorporates the WHO require- • verbal orders (e.g., unclear, inarticulate,
ments [23] as well as components of The Joint incomplete)
26 Preventing Perioperative ‘Never Events’ 415
Fig. 26.1 Comprehensive Surgical Checklist. Reprinted with permission from AORN.org. Copyright © 2016, AORN,
Inc.: Denver, CO. All rights reserved
• lack of standardization (e.g., drug doses, Ambulatory Surgery Centers (ASCs) have
names, routes) additional challenges as they may lack pharma-
• excessive variability in available doses of ceutical resources compared to tertiary care set-
medications tings [19, 38]. One comprehensive review of
• lack of unequivocal differentiation between ambulatory surgery facility-related medication
medications (e.g., geriatric/adult/pediatric/ errors in the State of Pennsylvania ([38], p. 89)
neonatal; look alike/sound alike; packaging found that of 502 events, the predominant medi-
design, coloration) cation error types were as follows:
• lack of clear, direct communication about
(e.g.) drug name/strength/amount between • Drug omission (26.7 %)
medication preparer (e.g., scrub person) and • Wrong drug (22.3)
user (e.g., surgeon) • Monitoring error/administering drug to patient
• failure to fully read medication labels with documented allergy (17.1 %)
• acceptance of nonapproved medication • Extra dose (4.2 %)
abbreviations • Wrong dose/overdose (3.6 %)
• inconsistent processes to remove outdated • Wrong dose/underdose (2.2 %)
medications • Other (14.1 %)
• reliance on use of surgeon’s procedure or pref-
erence card for drug preparation and use Of the classes of medications cited in the
• staff fatigue study ([38], p. 89), antibiotics were most often
Table 26.1 Strategies to prevent wrong patient/proce- ization, electrophysiology, and gastrointestinal
dure/site surgery never events
interventional suites). Grissinger and Dabliz [38]
• Employ checklists not only for the OR, but also for reported on deaths caused by the injection of the
OR schedulers and for Physician office personnel
wrong medication. One event that was discussed
to ensure accuracy, consistency, opportunities for
clarification (“possible” mini, endoscopic, etc.); occurred in an interventional suite where basins
see sample forms from Pennsylvania Patient Safety containing clear, but different, solutions were not
Authoritya labeled. The patient was accidentally injected
• Do not start procedure until all questions, with a topical antiseptic solution rather than the
concerns, and/or confusion about patient/site/
procedure are clarified and resolved
correct contrast material. These types of never
• Ensure all necessary documents (e.g., consents, events can occur in any setting and constant
H&Ps) are available vigilance by all staff is as important as any one
• Minimize interruptions during time-out (e.g., staff member feeling free to question (e.g.) which
music, unrelated chatter, inattention, telephones/ medication is in what container.
pagers) Medication errors can take place in a wide
• Enact policies developed by an interprofessional
variety of settings and clinicians must not limit
team that are evidence based and applicable to
every member of the surgical team; administrative themselves to preconceived notions of where or
executives and other nonclinical leaders must what can happen [43]. Although the focus of
support such policies and foster a culture of medication errors tends to be on drugs, clinicians
responsibility among all team members and
should use caution in relation to infusions of
professional groups
• Engage nurses as active and equal participants in
blood and blood products. Oxygen delivery (e.g.,
strategic and cost decisions related to the use of via nasal cannula) is another related consider-
technologies and tools that can reduce the risk of ation, particularly in patients who may be
errors related to misidentification restricted in their oxygen use (e.g., patients with
Source: Steelman and Graling [19] chronic obstructive pulmonary disease).
a
Pennsylvania Patient Safety Authority. Educational
Strategies for the prevention of medication error
tools. For surgeons’ offices: what can you do to prevent
wrong-site surgery? http://patientsafetyauthority.org/ never events are presented in Table 26.2.
EDUCATIONALTOOLS/PATIENTSAFETYTOOLS/
PWSS/Pages/home.aspx. Accessed 3 May 2016
ressure Ulcers and Related
P
cited—33.9 % of reported errors. Ambulatory Positioning Never Events
facilities that do not have an onsite pharmacy or
pharmacist should have a process for communi- Pressure ulcers occur as a result of skin compres-
cating with pharmaceutical professionals for sion, which impedes blood flow and damages
clarification, information, and education for all underlying tissue; prolonged pressure can cause tis-
staff. It is especially imperative that anesthesia sue decay. Although pressure ulcers are commonly
providers, surgeons, and nursing staff have clear, associated with long-term care, extended periods of
direct, and unambiguous policies and communi- uninterrupted pressure and friction during surgical
cation processes that reduce the risk of error— procedures put patients at risk for these injuries
particularly those related to miscommunication [44–46]. Table 26.3 lists the four stages of pressure
(or lack of effective communication). ulcers according to the degree of tissue damage.
Medication safety applies to all healthcare set- The Braden Scale [44] is the most common
tings—inpatient and ambulatory as well as clin- tool used for assessing risks for acquiring pres-
ics and physicians’ offices [41, 42]. Perioperative sure ulcers; however, the Braden Scale does not
clinicians should consider safety considerations capture all the critical risk factors for the devel-
in the many expanding arenas of practice, nota- opment of injury in surgical patients [45]. The
bly the interventional suites where an increasing Munro [46] scale was created by a perioperative
number of procedures are performed jointly by nurse to capture factors specific to surgical
perioperative/surgical professionals and interven- patients and has demonstrated promise for pre-
tional clinicians (e.g., radiology, cardiac catheter- dicting patients at risk during surgery.
Table 26.2 Strategies to prevent medication error never events

Promote an interprofessional approach to medication safety
• Support a medication safety committee that includes surgeons, anesthesia personnel, nurses, and pharmacists, as
well as risk managers, purchasing personnel, information technology (IT) members, and administrative
champions
• Include patients and community members in medication safety initiatives
Procure and store medications and related supplies in a safe and efficient manner
• Have a contingency plan for ‘back-ordered’ medications
• Ensure that out dates are monitored and out dated drugs are removed
• Monitor temperature and humidity levels of areas where medications are stored
• Consider automated drug dispensing storage systems to restrict and document access
• Promote use of single- versus multidose vials of medications
• Standardize medication carts and separate look-alike and sound-alike drugs
Medication orders should be clear, accurate, and unambiguous
• Limit verbal medication orders; when used, read back, and record
• Computerized-provider order entry (CPOE) systems should be used whenever possible
Actively engage pharmacists in perioperative medication ordering and dispensing
• Have pharmacists review medication orders
• Include pharmacists in grand rounds
Clinicians should review the patient’s health record before medication administration
• Before administering a medication, confirm patient’s identity, metric weight, medication history, current
medication history, and allergies
• Involve the patient (or surrogate), when possible, to identify current medications, allergies, and preferences
(when applicable)
Administer medications in a safe manner
• Verify correct patient, drug, route, amount/dose, time, indications, and contraindications
• Avoid interruptions during medication preparation
• Have available weight-based conversion charts and other tools to ensure correct calculations
• Encourage clarification of all medication orders
• Label all medication containers (e.g., syringes, metal basins, plastic medication cups)
• Make use of safety devices (e.g., infusion pumps, safety needles, sterile transfer devices)
• Collaborate with IT to develop ‘prompts’ in the electronic health record for (e.g.) prophylactic antibiotic
administration
Monitor the patient for intended or unintended reactions to medications
• Document reactions to medications
• Collaborate with surgical colleagues to manage medication-related crises emergencies
Source: Grissinger and Dabliz [38]; Steelman and Graling [19]; Smetzer et al. [39]; AORN [41, 42]
ISMP Guidelines. http://www.ismp.org/Tools/guidelines/default.asp. Accessed 3 May 2016
Primiano and fellow researchers [47] studied • Male sex—twice as many males develop pres-
the prevalence of, and risk factors for, pressure sure ulcers
ulcer development during general, orthopedic, • Positioned on thin (1.5″–2″) foam OR bed
neurological, cardiothoracic, gynecologic, and pads
vascular procedures lasting longer than 3 h. They • Major skin abrasions
and others [48–50] found several risks for the • Older age (less elastic, smaller, more calcified
development of pressure injuries: blood vessels)
Table 26.3 Four stages of pressure ulcers according to the degree of tissue damage
Stage I: Observable pressure-related alteration of intact skin when compared to adjacent tissue and may include one
or more of the following: skin temperature (warm or cool), tissue consistency (firm or boggy), and sensation (pain
or itching). Most pressure ulcers that develop during a surgical procedure are stage I cases
Stage II: Partial skin loss of the epidermis and dermis. The skin is eroded or blistered or has shallow craters
Stage III: Full skin loss, possibly down to, but not through, the fascial layer, causing deep craters
Stage IV: Extensive tissue loss. Muscle, bone, and supporting structures show
National Pressure Ulcer Advisory Panel. Pressure ulcer category/staging. Text and illustrations. http://www.npuap.org/
resources/educational-and-clinical-resources/pressure-injury-staging-illustrations/. Accessed 3 May 2016
• Obesity (more weight and pressure on bony standard OR bed mattresses). Recommendations
prominences); morbidly obese patients (body for the prevention of pressure ulcer never events
mass index/BMI of 30 and above) are particu- are listed in Table 26.4.
larly at risk [50]. Although pressure injuries are often related to
• Malnourishment (increases the risk and can adverse events associated with positioning,
retard healing; albumin levels under 3.0 [nor- another serious adverse event can occur when a
mal albumin = 3.5–4.5 mg/dL] pose a risk for patient falls during transfer from the gurney to
pressure injuries) the OR bed, during positioning on the OR bed,
• Diabetes mellitus or hypertension during Trendelenburg or reverse Trendelenburg
• Length of surgery (susceptible patients can positions, or when the patient becomes agitated,
develop ulcers during procedures that last e.g., during induction or local anesthetic proce-
only one half-hour to 1 h) dures. It is important to ensure that patients are
• Moisture (e.g., pooling of prep solutions; staff secured with safety straps and that there are staff
not allowing prepping solutions to dry members on either side of the patient as well as
completely) the head and the feet during transfers and posi-
• Shearing and friction (when outer layer of tion changes [54]. Additional positioning consid-
skin slides across a surface and the underlying erations are listed in Table 26.5.
tissues shift or move; can also occur if the
patient is pulled or moved without being
lifted) Surgical Site Infections
• Warming blankets (the risk of burns should be
considered. For example, a warming blanket Surgical site infection (SSI) is an infection
under the patient warms the tissue, therefore occurring in an incisional wound within 30
less blood travels to the warmed area, depriv- days of a surgical procedure, according to the
ing the tissue of oxygen) Centers for Disease Control and Prevention
(CDC) [58]. The occurrence of a surgical site
Guidelines for patient positioning in the OR infection during the postoperative period may
from the National Pressure Ulcer Advisory significantly affect patient recovery and hospi-
Panel [51] and the European Pressure Ulcer tal resources leading to longer length of stay,
Advisory Panel [52–54] recommend using a readmission, and possible delay in resumption
pressure redistributing mattress on the OR bed. of normal daily activities and return to employ-
Some organizations report insufficient evidence ment. This surgical complication can be devas-
to recommend a specific pressure redistribution tating to the patient and family, as well as to
intervention or product [55, 56], but a random- healthcare institutions that can be penalized
ized controlled trial [57] did demonstrate that financially for SSI readmissions through
viscoelastic polymer pads reduced the incidence decreased reimbursement and other financial
of pressure ulcer formation (compared to the penalties. There is no single factor which
Table 26.4 Recommendations for preventing pressure ulcer never events

1. Assess the patient’s skin continuously. Before positioning, assess the patient’s overall skin condition.
Immunocompromised patients (e.g., diabetics, patients undergoing steroid, chemotherapy, or radiation
treatments) are especially at risk
2. Use a pressure ulcer assessment scale to measure the patient’s risk. The Braden Scale, the most widely used
assessment tool (available at http://www.bradenscale.com/images/bradenscale.pdf) is made up of six subscales
scored from 1 to 4 that measure a patient’s sensory perception, skin moisture, degree of physical activity, ability
to change and control body position, usual food intake pattern, and amount of assistance they require for
moving. Lower scores (less than 20) indicate higher risks of pressure ulcer development. Reassess these patients
in PACU/ICU to ensure problem areas did not develop or preexisting skin conditions were not exacerbated
during surgery
A perioperative pressure ulcer scale has been developed by Munro [46] who identified a need for an OR-specific
assessment tool
3. Anticipate the patient’s position. The circulating nurse should confirm the patient’s surgical position with the
surgeon and have necessary positioning supplies and devices
4. Use thick gel pads. Thirty percent of patients in one study [47] who were positioned on thin foam table pads
(1.5″–2″) developed pressure ulcers. Surface pads should be 3″–4″ thick to maintain skin integrity
5. Keep OR bed sheets smooth. Wrinkles in sheets can cause skin breakdown; smooth OR bed mattress covers
before placing patients on them
6. Pad bony prominences with cushioning devices. Use appropriate cushioning devices/pads that maintain normal
capillary pressure of 32 mmHg or less, are durable, resist moisture and microorganisms, are fire resistant, are
nonallergenic, and are easy to clean and disinfect
7. Keep pressure off heels. Use the foam heel protectors or place a pillow or positioning under patients’ heels to
keep off the OR bed surface
8. Avoid elevating patients’ ankles (this can actually increase pressure ulcer development risks). Brief periods of
heel/ankle elevation may be required for prepping in certain procedures (e.g., saphenous vein removal during
coronary artery bypass surgery)
9. Apply sacral padding for patients undergoing prolonged procedures (e.g., greater than 2 or more hours) in the
supine position
10. Avoid leaning on patients during surgery. Surgical team members of the surgical team may inadvertently lean
on the patient during surgery in order to improve the view of the surgical site or reach for needed instruments
11. Move portions of the patient’s body when possible. This is challenging for prolonged cases (e.g., cardiac or
other surgeries of 4–5 h or more) but there may be some opportunities to enhance perfusion to certain areas. For
example, a staff person may reach underneath the drapes to gently shift a patient’s extremities several times
throughout a procedure. Anesthesia providers may be able to briefly lift the patient’s head. It does not take long
for circulation to return to potential problem areas and slight movements can reduce the risk of developing
pressure ulcers
12. Document the skin the pre-op and post-op skin condition. Additionally, document the positioning devices used
as well as the protective devices. Observed injuries should be documented per institutional policy
Source: AORN [54]; Braden and Bergstrom [44]; European Pressure Ulcer Advisory Panel [52]; Munro [46]; National
Pressure Ulcer Advisory Panel. Pressure ulcer category/staging. Text and illustrations. http://www.npuap.org/resources/
educational-and-clinical-resources/pressure-injury-staging-illustrations/. Accessed 3 May 2016; Primiano et al. [47];
Sullivan and Schoelles [49]
Table 26.5 Positioning considerations to reduce the risk of pressure ulcers and falls
• Supine Position. In the supine position pressure sores most commonly occur on the heels, sacrum and ischium,
the back of the skull, and the shoulder blades. These areas should be protected with cushioning pads, and heels
should be kept off the OR bed. Avoid elevating the patients’ ankles as this can actually increase pressure ulcer
development risks
• Lateral Position. Cushion the ear, shoulder, thigh, knee, ankle, and foot of patients in the lateral position; place
pillows between legs; secure body with a safety strap
• Prone Position. Place padding under the face, chest, and feet to prevent wounds on the nose, forehead, chest,
feet, and toes
• Lithotomy Position. Pad the lateral or posterior knees and ankles to prevent pressure injuries
Source: AORN [54]
predicts whether a patient may develop a surgi- study by Edmiston et al. [68] provided clear evi-
cal site infection and plans developed to reduce dence for using chlorhexidine gluconate (CHG)
SSIs should embrace a variety of factors along preoperatively to reduce the risk of surgical site
the patient’s continuum of care. infection. In a 2013 study, Graling and Vasaly
Individual patient characteristics may be asso- [69] found that 4 % CHG delivered p reoperatively
ciated with improved surgical outcomes. Four by cloth bath reduced surgical site infections in
preoperative specific factors have been identified general and vascular surgery. A recent study by
by the Strong for Surgery team in Washington Edmiston et al. [70] provides evidence for a stan-
State: adequate nutrition, glycemic control, smok- dardized showering regimen to achieve maximal
ing cessation, and appropriate medications [59– skin surface concentrations of CHG 4 % in surgi-
61]. Strong for Surgery provides a presurgery cal patients preoperatively.
checklist to doctor’s offices to help with educa- The optimal use of preoperative antibiotics
tion, communication, and standardization of best has been a focus in a number of major projects
practices, and hence to improved clinical out- looking to reduce complications of healthcare.
comes. Other preoperative patient factors related These include the Prevention of Surgical Site
to surgical site infection include specific medi- Infection, Institute for Healthcare Improvement,
cation use, such as steroids or immunotherapy 5 Million lives campaign [71], and The Joint
which may naturally c ompromise wound healing, Commission’s Surgical Care Improvement
and colonization with Staphylococcus aureus, Project (SCIP) [72].
increasing chances of developing methicillin- The Centers for Disease Control and
resistant Staphylococcus aureus (MRSA) [62]. Prevention’s (CDC) classic 1999 Guidelines for
Bacteria are becoming increasingly resistant Prevention of Surgical Site Infection [73] provide
to antibiotics making SSI prevention even more category IA evidence for preoperative antibiotic
challenging. The use of intranasal mupirocin prophylaxis. Prophylactic antimicrobial agents
ointment for Staphylococcus aureus decoloni- should be administered only when indicated and
zation has resulted in statistically significant should be selected based on the efficacy against
reduction of S. aureus SSIs [63]. Staphylococcus the most common pathogens causing SSI for a
decolonization is routinely used prior to cardiac specific operation and published recommenda-
surgery and total joint arthroplasty and is tions. Appropriate and timely administration of
becoming more common in other procedures. preoperative antibiotics for routine surgical cases
Bundles comprised of decolonization, preoper- is also a perioperative patient quality measure
ative showers, and antibiotic prophylaxis defined by The Surgical Care Improvement
should be considered [64]. Several protocols Project (SCIP), a national program aimed at
have specifically targeted decolonization of reducing perioperative complications and is a
methicillin-sensitive S. aureus (MSSA) and quality benchmark metric for Centers for
methicillin-resistant S. aureus (MRSA) using Medicare and Medicaid Services [72].
intranasal mupirocin and chlorhexidine washes Antibiotics should be administered by the
and demonstrate [65, 66] effectiveness for intravenous (IV) route and the initial preopera-
reducing MRSA/MSSA colonization. tive dose timed to establish optimal tissue and
Skin is a major potential source of microbial serum concentrations prior to incision.
contamination in the surgical environment. When Therapeutic levels of the antibiotic agent should
implementing a program to reduce SSI, one must be maintained in serum and tissues throughout
look at the patient and the provider to manage the operation and until, at most, a few hours after
reduction of skin flora. Evidence suggests that the incision is closed in the operating room. Team
preoperative antiseptic showers reduce bacterial members should standardize protocols using
colonization and may be effective at preventing national guidelines, using preprinted or comput-
SSIs [67]. No one antiseptic has been found to be erized standing orders, verify administration dur-
better than another for preventing SSI. A 2010 ing time-out processes, and have the preoperative
Table 26.6 Recommendations for reducing surgical site infection never events
Preoperatively
Patient actions
Perform preoperative antiseptic showers with prescribed cleanser
Staff actions
Assess patient predisposing factors; optimize risk reduction strategies for elective surgical procedures
• Nutrition
• Glycemic control
• Smoking cessation
• Steroid and/or immunotherapy
• MRSA colonization
Perform frequent hand hygiene
Optimize incision site preparation with limited to no hair removal, preferably in preoperative area; use clippers
if hair removal required
Administer preoperative antibiotics within time frame to maximize tissue perfusion
Intraoperatively
Maintain optimal surgical environment (temperature, humidity)
Use EPA-approved hospital disinfectant to clean surfaces and equipment; inspect surfaces, equipment prior to
room setup
Minimize operating room traffic (enter/exit through sterile core)
Sterilize instruments according to manufacturer’s instructions
Minimize the use of immediate use steam sterilization
Don clean OR attire and personal protective equipment
Cleanse (prep) skin with appropriate surgical antiseptic
Adhere to standard principles of operating room asepsis and surgical technique (e.g., handle tissue carefully,
eradicate dead space when closing incisions)
Maintain normothermia
Classify wound at end of case (i.e., clean, clean contaminated, contaminated, infected)
Postoperatively
Incision care
Remove drains and catheters as soon as possible
Provide adequate nutrition for wound healing
Source: AORN [67, 74]; Edmiston et al. [70]
nurse or anesthesia professional assign dosing in the OR to prepare their equipment, insert intra-
responsibilities [63]. Team members play impor- venous lines and catheters, etc. [77].
tant roles throughout the perioperative period; Preparation of the surgical incision site may
Table 26.6 identifies actions by patients and staff include hair removal and application of a surgical
in the perioperative, intraoperative, and postop- skin antiseptic. Hair removal should only be per-
erative periods. formed when necessary. When hair removal is
Another safety measure is hand hygiene, performed, clipping hair lowers the risk of SSI
which has been recognized as a primary method development rather than shaving hair with a razor
of decreasing healthcare-acquired infections [67]. The effectiveness of any skin antiseptic
[75]. Hand hygiene, handwashing, and surgical used for the surgical skin prep can be affected by
hand scrubs are the most effective way to prevent a number of factors. The effectiveness of each
and control infections and represent the least solution depends on concentration, temperature,
expensive means of achieving both [76]. Despite particular germ or virus, and contact time.
this, studies have showed remarkably low hand Following manufacturers’ recommendations for
hygiene rates by surgical providers as they enter use optimizes results. Skin antiseptics should be
chosen for the individual patient based on patient areas and reduces the risk of healthcare-associated
assessment, the procedure type, and a review of infections [73]. All surgical instruments should
the manufacturer’s instructions for use and con- be sterilized according to published guidelines
traindications [78]. and manufacturers’ instructions. Instruments
Preparation of the surgical site is one factor in should be prepared using immediate use steam
creating a safe environment. The physical envi- sterilization (formerly called “Flash” steriliza-
ronment within a surgical suite should support tion) only if they are required for immediate use
patient care to reduce the risk of developing a and not for convenience, or to avoid purchasing
surgical site infection. The AORN Guidelines for additional instruments, or to save time.
a safe environment of care provide guidance for Implementing sterile techniques when preparing,
the design and maintenance of building struc- performing, or assisting with surgical procedures
tures to accommodate a perioperative procedure is the cornerstone of maintaining sterility and
as well as guidelines for hazardous waste and preventing microbial contamination. Studies
storage conditions [79–81]. looking at colorectal surgery have shown that iso-
Another environmental concern is the move- lation techniques and the use of closing trays dis-
ment of people and supplies. Traffic patterns should courage the seeding of enteric contents to the
facilitate movement of patients, personnel, sup- incision site has been reported to reduce the inci-
plies, and equipment through the OR suite, with dence of SSI [83, 84].
restriction levels intended to provide the cleanest Additional clinical trials have shown that
environment possible. The number and movement hypothermia increases the incidence of serious
of individuals during an operative procedure should adverse consequences including surgical site
be kept to a minimum. Evidence suggests that bac- infections [85]. Several recent studies have
terial shedding increases with activity and that air shown the use of evidence-based surgical care
currents may pick up contaminated particles shed bundles in patients undergoing colorectal surgery
from patients, personnel, and drapes and distrib- significantly reduced the risk of SSI; included in
ute them to sterile areas [82]. Additionally, an these bundles is maintaining normothermia [61,
optimal surgical environment maintains tempera- 84, 86]. Perioperative personnel should evaluate
ture and humidity to deter microbial growth. a patient’s risk for unplanned, inadvertent hypo-
Perioperative personnel should use an thermia and implement strategies such as tem-
Environmental Protective Agency-registered dis- perature monitoring and patient warming in order
infectant to clean surfaces and equipment, and to adjust environmental conditions according to
physically inspect surfaces and equipment prior to patient needs [87].
preparing the OR for surgery [74]. Postoperative care considerations should be
There are several practices that reduce the reviewed at the conclusion of the procedure by
spread of transmissible infections when prepar- the surgical team using a debriefing process [23].
ing for surgery or working in the OR [83]. Additionally, determining the surgical wound
Perioperative personnel should don clean scrub class assists clinicians in gauging the risk for
attire and wear personal protective equipment infection. Surgical wound classification is deter-
(PPE) to protect both the patient and provider mined using the wound classification scheme
from microbial contamination and blood borne from the CDC. The CDC recommends four surgi-
pathogen exposure. To deter passage of microor- cal wound classifications:
ganisms, particulates, and fluids between sterile
and unsterile areas, PPE should be resistant to 1. Clean,
tears, punctures, and abrasions [83]. Sterile 2. Clean-contaminated,
drapes provide a barrier that minimizes the pas- 3. Contaminated, and
sage of microorganisms from unsterile to sterile 4. Dirty or infected wounds [73].
This classification scheme reflects the proba- (ESU) through a delivery device (i.e., the electro-
bility of infection and should be determined by cautery pencil) to the patient’s tissue, where the
the surgeon at the end of the surgical procedure. tissue is either ‘cut’ or coagulated. Two modes
AORN has developed the Surgical Wound can be employed:
Classification Decision Tree (Fig. 26.2) to assist
in decision making for surgical wound classifica- • Monopolar, wherein electricity flows from the
tion [88]. source of energy through the ESU pencil to a
Wound classification is subject to change; specific area on or in the patient where heat is
therefore, it should be assigned in consultation generated, producing coagulation or cutting.
with the surgeon at the end of the procedure and The electrical energy then passes through the
documented in the perioperative record ([89], patient to a dispersive electrode (i.e., the
p. 491–511). Postoperative incision care is a ‘Bovie’ pad) where the energy is returned to
significant factor in reducing SSIs; practices the generator and the electrical circuit is
include sterile dressing changes as needed and completed.
removal of drains (e.g., chest tubes) and cathe- • Bipolar, wherein electricity flows between
ters (e.g., urinary drainage catheters) as soon as one tip of an electrical device that looks like a
possible [90]. pair of forceps, into the patient’s tissue, and
returns to the other tip of the device, thereby
completing the electrical circuit; a dispersive
lectrical and Other Energy-Related
E pad is not required because the electrical
Never Events energy returns directly to the generator from
the electrosurgical device itself [91].
A variety of energy sources and modalities are
employed during surgery. Considerable informa- It is not unusual to employ both monopolar
tion is available about energy modalities, their and bipolar devices during one surgery—for
mechanism of action, their unique characteris- example, performing simultaneous endoscopic
tics, and their safety risks. Ball [91] offers an vein harvesting with a bipolar device while dis-
extensive description (with illustrations) of the secting the mammary artery with a monopolar
many modalities employed in the perioperative device during coronary bypass grafting. Patients
setting. Additionally, the Society of American undergoing a procedure that employs monopolar
Gastrointestinal and Endoscopic Surgeons energy would require the application of a
(SAGES) created the Fundamental Use of dispersive pad, regardless whether other, bipolar,
Surgical Energy™ (FUSE) curriculum in 2010 to devices are also employed. When applying a
address the safe use of endoscopic energy sources dispersive pad, commonly performed by the cir-
[92–94]. Table 26.7 (Surgical Energies and culating nurse, the clinician should place the pad
Considerations) lists various types of energy on clean, dry skin overlying healthy muscular tis-
sources and considerations for their safe use. sue (which conducts electricity better than adi-
These energy sources may be employed in the pose tissue), and as near as possible to the surgical
traditional ‘open’ surgical manner as well as the site. Areas on the patient’s skin with excessive
video-assisted, endoscopic, and interventional hair, scar tissue, tattoos, or over bony promi-
routes. Although there are extensive available nences or distal to a tourniquet should be avoided
information and initiatives developed by profes- for pad placement because hair, scar, bone, or
sional organizations such as SAGES [92] and poorly vascularized (e.g., distal to the tourniquet)
AORN [96, 97], energy-related patient injuries can increase impedance of electrical energy flow,
continue to occur [98]. create heat, and potentially burn tissue [96, 99].
One of the oldest and most common sources If needed, hair can be clipped to access a suitable
of energy is electrosurgery, which directs the site for the pad. Surgery performed on more than
flow of electrons from an electrosurgical unit one site may require the use of two dispersive pads.
Fig. 26.2 Surgical Wound Classification Decision Tree. Reprinted with permission from AORN.org. Copyright ©
2016, AORN, Inc.: Denver, CO. All rights reserved
Table 26.7 Surgical energies and safety considerations

Energy type Safety considerations
General considerations: all • Confirm that energy source is in proper working order
energies • Have backups available if there is energy failure
• Employ the appropriate energy for its intended effect
• Be aware of energy-specific risks to patients and staff (e.g., ESU—burns;
cryo—cold injury)
• Never silence alarms
• Maintain in good working order with regular scheduled checkups
• Know how to trouble shoot problems, or, whom to contact
• Remove from service when not functioning; send for repair promptly
Electrosurgery • Conduct risk assessment for fire triangle (i.e., fuel, oxidizer, ignition source)
elements
• Attach appropriate size dispersive pad; avoid placing pad over metallic
implants (e.g., prosthetic hip replacement, pacemaker generator)
• Unless certain that only bipolar energy to be employed, apply a dispersive pad
onto the patient’s skin
• Check instruments for insulation integrity
• Ensure flammable prepping agents are completely dry before draping
• During head and neck surgery, ensure that moist sponges can be made
available promptly to surgical team members (including anesthesia personnel)
• Holster active electrode (ESU pencil) when not in use
• Do not wrap cords around metal towel clips or clamps
• Keep electrode tip clean and free of eschar
• Ensure that appropriate personnel are available to reprogram implanted
devices (e.g., ICDs, pacemakers) as needed
• Evacuate plume
Argon beam coagulator • All ESU precautions
• Vent laparoscopic entry sites
• Monitor intraabdominal pressure
• Be alert for gas embolism
LASER (light amplification by • Ensure eye protection for surgical team members (including patient)
stimulated emission of • Place moist towels around surgical field
radiation) • Place laser on standby mode when not in use
• Place ‘laser alert’ signs (on OR door) when in use
• Evacuate plume
Cryo energy • Specify activation time
• Have saline available to facilitate release of freezing probe to tissue
Radiofrequency ablation (RFA) • Need multiple dispersive electrodes; 90° angle to current flow
• Manage patient temperature
Endoscopy with monopolar • Assess bowel prep; want ↓methane gas
devices (snare, hot biopsy • Remove jewelry
forceps, sphincterotome, argon • Assess presence of CIED
plasma probe)
• Concern for perforation and bleeding
• Use standby mode when not in use
• Ensure proper cleaning and sterilization of endoscopic devices and instruments
Endoscopy with bipolar • May use needle for sclerosing agent
(MPEC gold probe) • Ensure proper cleaning and sterilization of endoscopic devices and instruments
• Avoid placing cables with light activated on patient drapes
(continued)
Energy type Safety considerations
RF array for GERD • Need dispersive electrode required
Ultrasonic energy • No dispersive pad needed
• Handle blade carefully, holds residual heat
• Do not place on drapes
Microwave • Often used with ultrasound guidance
• No dispersive electrode required
• Monitor patient temperature
Pediatric considerations • Choose pads according to weight
• Place pad as close to surgical field as possible
• Neonate pads often placed on back
• Always protect pad from fluid exposure
Electromagnetic interference • Have defibrillation and pacing equipment available
(EMI) (most commonly comes • Use bipolar or ultrasonic over monopolar sources if possible
from a CIED) • Place pad nearest surgical site, do not cross CIED
• ECG lead placement does not affect EMI
• Pacer dependent patients most at risk
• May use magnet to go asynchronous
• Interrogate for proper function postprocedure
Source: Ball [91]; Feldman et al. [93, 94]; Lindsey et al. [95]; Society of American Gastrointestinal and Endoscopic
Surgeons (SAGES) [92]; Strong for Surgery [59]
CIED Cardiovascular Implantable Electronic Device, ECG electrocardiogram, EMI electromagnetic interference, ESU
electrosurgical unit, GERD gastroesophageal reflux disease, ICD Implantable cardioverter Defibrillator, MPEC multi-
polar electrocoagulation, RF radiofrequency, RFA radiofrequency ablation
A common site that allows the placement of two (ICD); reprogramming of the device(s) may be
pads is the buttocks; a pad on each thigh may required and the perioperative staff should have
also be feasible when performing surgery on contact information for the device manufactur-
both legs [96]. er’s representative. Shortly after surgery, the
Electrical devices can cause burn injuries to pacemaker and/or ICD function should be evalu-
both patients and staff. Patients undergoing head ated by the responsible implanting physician (or
and neck surgery (where there may be accumu- surrogate) and the manufacturer’s representative.
lated oxygen under the patient’s drapes) are at A bipolar, or a battery-powered, cautery device
especial risk for upper body and airway burns may be feasible if more extensive cautery is not
that can be triggered by the electrical energy needed. Precautions related to interference with
device [100]. Electrical and other energy sources device function are applicable to many additional
can also lead to fires that can threaten not only implanted electronic devices [101] (e.g.):
the immediate surgical team but also surrounding
units. The subject of fire is only briefly men- • Deep brain stimulators
tioned in this section; the topic is more fully dis- • Spinal cord stimulators
cussed by Bruley (see Bruley, Chap. 10). • Bone growth stimulators
Electrosurgical energy also presents nonther- • Other nerve stimulators
mal risks to patients. For example, the use of • Cochlear implants
electrosurgical energy can interfere with a • Ventricular assist device
patient’s electrocardiogram (ECG) and poten-
tially adversely affect the performance of a pace- Ultrasonic devices employ mechanical vibra-
maker or implantable cardioverter defibrillator tion of high-frequency sound waves (greater
than 20,000 Hz) that enable the user to cut and and technique may create additional safety chal-
coagulate tissue. The tip of the hand piece comes lenges. For example video-assisted laparoscopic
in various shapes: blade, ball, and hook [91]. and other endoscopic procedures differ from tradi-
Some of the advantages of ultrasonic devices are tional ‘open’ surgeries in a number of ways. One is
as follows: that when emergencies occur—e.g., sudden hem-
orrhage—there needs to be a prompt and efficient
• Adjacent tissue is damaged less than it might transition in technique and access in order to con-
be with laser or electrosurgical energy trol the bleeding; this may require a new incision,
• Nerve or muscle stimulation does not occur a new set of instruments, and different mecha-
(due to the absence of electrical current in the nisms for controlling bleeding (e.g., placing a
tissue) hand on the bleeding site cannot be achieved
• Absence of surgical smoke (plume) laparoscopically).
Additional considerations include the use of
Surgical smoke has become increasingly scru- fluids or gases to distend the abdomen via the
tinized for the hazards found within the plume— laparoscopic route and the potential risks to the
viruses; toxic gases; cellular (living and dead) patient that an overdistended abdomen may pose.
contaminants; and vapors such as benzene, form- These potential complications may not them-
aldehyde, and hydrogen cyanide [95, 96, 102]. selves constitute a never event but one’s aware-
Evacuation of surgical smoke increasingly is ness of risks and preparation for contingency
seen as a safety practice [91]. planning to address complications is consistent
Another form of energy, radiation, is generally with Kizer and Stegun’s [1] definition of an event
employed as a diagnostic imaging modality but that should never occur.
is increasingly used as an integral component of
therapeutic interventions performed in hybrid ORs
and endovascular suites for repair of aneurysms Retained Surgical Items
and other cardiac and vascular abnormalities.
Radiologic energy/fluoroscopy is employed in The study by Gawande and colleagues pub-
a growing array of imaging-based procedures lished in 2003 [105] was one of the first to illus-
that carry their own inherent risks but also as a trate the serious consequences of retained
diagnostic tool to look for, and identify, possible surgical items (RSI, formerly called retained
retained surgical items. Radiation safety remains foreign bodies); these included infection, pro-
an important component of these newer, innova- longed hospital stay, reoperation, fistula, and
tive technologies. Tracking and documenting death. The study authors reviewed medical-
radiation exposure levels as well as ensuring that malpractice claims by patients with retained
surgical team members protect themselves (and surgical sponges or instruments to identify the
the patient’s body parts not requiring radiation following major risk factors for RSI:
exposure) with lead barriers, glasses, and cover-
ings (e.g., tops, skirts, gloves, and thyroid shields) • Emergency surgery
is an important safety consideration [103]. • Procedures with unplanned changes, and
Perioperative colleagues should also be consid- • Patients with higher body mass index (BMI)
ered by posting signs on the OR door(s) alerting
staff members that radiologic procedures are Interestingly, the patient’s sex, changes in
being performed [104]. nursing personnel, the presence of multiple
Although the various energies themselves (e.g., teams, and the amount of blood loss were not
electricity, laser, microwave, radiofrequency) pose associated in this study with an increased risk
their own inherent safety risks, the surgical route of RSI.
Lincourt et al. [106] and Wang et al. [107] Related causes of failure to prevent RSI were the
confirmed the study’s [105] findings of signifi- focus of a healthcare failure mode and effect analy-
cant increased risk for RSI in: sis by Steelman and Cullen [110]. They identified
the following as the most frequently cited reasons:
• Procedures performed on an emergency basis
• Procedures with unexpected changes during • Distraction
the surgery • Multitasking
• Noncompliance with the facility’s ‘count’
Increased BMI was not a significant finding in policy
the Lincourt [106] and Wang [107] studies, and • Time pressure ([110], p. 682)
Rowlands [108] actually found an inverse rela-
tionship between increased BMI and risk of Several recommendations address the under-
RSI. Rowlands also found that complex proce- lying issues and risks:
dures, an increased number of personnel, and a
greater number of specialty teams posed higher • Members of the perioperative surgical team
risks for RSI. None of these findings is surprising should participate in team training that pro-
to clinicians who have participated in a trauma or motes active communication and collabora-
emergency procedures—and it would not be sur- tive practice [111–114].
prising if a blood-soaked, compressed sponge was • All members of the surgical team have a respon-
not visualized in the retroperitoneum or pleural sibility for preventing RSIs [111–113, 115].
cavity of a patient with a small or large BMI—if • When an RSI event occurs, an investigation
surgical team members failed to follow policies or should be carried out that reflects human factors
guidelines, or, if behavioral or environmental fac- considerations, e.g., communication failures,
tors adversely affect team function. lack of situational awareness, mental fatigue [8].
Three behavioral and environmental catego- • Distractions should be minimized and team
ries were designated by Rowlands and Steeves members alerted that the count is about to
[109], who reviewed the perioperative stories of commence; interrupted counts should be
perioperative registered nurses (RNs) and surgi- restarted [19, 111–113].
cal technologists (STs) relating the counting pro- • Team members should verbally verify the
cedures during surgery. These general areas and final count as part of a checklist [111–113].
examples included: • The RN circulator should record the count
immediately after each item is counted (e.g.,
1. Bad behavior blades, cautery tips, sutures), on a surface
(a) Lack of respect (e.g., ‘white board’ placed on the wall in the
(b) Sloppiness (e.g., sponges in disarray, counted OR) visible to all team members [111–113]; if
items thrown into trash, inattention) the count occurs away from the ‘board’ (i.e.,
(c) Inconsistent practice next to the surgical table where the countable
2. General chaos items are located), then the Circulator should
(a) Loud noise document the count on paper and transcribe
(b) Lack of preparation the numbers onto the white board. It is impor-
(c) Assignment changes tant for the counted items to be fully visual-
(d) A fast pace ized when counting.
3. Communication difficulties • Create a no-interruption zone that prohibits non-
(a) Idle chit-chat essential conversation when counting [113].
(b) Lack of proper equipment
(c) Resistance to sharing information Additional recommendations are listed in
(d) Difficulty working together ([109], p. 413) Table 26.8.
Table 26.8 Recommendations for preventing retained surgical items

All surgical team members
• When possible, limit soft (e.g., cloth, plastic) items used to those that are radiopaque; items that are not
radiopaque should be counted and documented
• When counting, separate items (e.g., sponges) and visualize each item
• When counting, verbalize that the count is starting
• When performing ‘closing’ counts, avoid counting in a loud voice, but ensure that every counted item has been
visualized
• The process of selecting and purchasing products developed to prevent RSIs should include all members of the
surgical team
• Employ adjunct technologies (e.g., RF devices) per manufacturer’s instructions
Surgeons and assistants
• Be aware of items employed
• Before the closing count begins, explore the wound methodically and completely
• Notify team members when items that remained within the wound (e.g., for hemostasis) at the start of the final
count have been removed and returned to the scrub person
• If a suture needle or instrument breaks during use, retrieve broken parts and pass to the scrub person
• Inform patients that a ‘never event’ occurred
Scrub personnel (RN or ST)
• Perform a baseline count
• Be aware of items employed by surgeon and assistant
• Whenever possible, engage in ‘exchange’ (e.g., hand new suture to surgeon after receiving used suture)
• Arrange items on the field and back table, mayo tray near end of procedure in order to facilitate more efficient
count
• In situations where there is persistent, copious bleeding, initiate a count in order to be aware of the number of
sponges used and remaining
• Avoid altering counted items
• Count the components of instruments with multiple pieces (e.g., retractors)
• Upon verification of all counts being correct, clearly verbalize to the surgeon and team that there is a ‘correct
count’
Circulating RN
• Perform a baseline count
• Maintain an awareness of the stage of the procedure and be alert to possible needs for (e.g.) extra sponges (with
persistent bleeding); suture (for repairs or suture reinforcement
• Avoid loud music
• Request that pagers or other communication devices are off, on silent mode, or on standby
• Provide dressing sponges only after the final count
• Keep up with sponges that have been passed off the field; do not allow an excessive number of sponges to
accumulate (prolonging the final count)
• Employ sponge bags or other mechanism for separating and visualizing sponges
Anesthesia personnel
• Do not hesitate to speak up if there is uncertainty about removal of sponges or other items
• Maintain ‘situational awareness’
• Do not use counted items for (e.g.) line insertions or other anesthesia procedures
Other staff (e.g.)
• Cardiovascular Technologists: may assist with insertion of monitoring lines. Should not use “countable”
sponges and should keep these and other items separate from counted items
• Radiologists: if required to have an x-ray for RSI, inform the radiologist and/or technologist of the item to be
identified, the surgical site, and the best position; provide radiology protection for staff and patient during x-ray;
provide a sample of the item being looked for (e.g., “pill” sponge)
Source: AORN [111, 112]; AORN. RP summary: recommended practices for prevention of retained surgical items.
AORN J. 2012;95(2):220–21; Goldberg and Feldman [115]
RN Registered Nurse, ST Surgical Technologist’, RF radiofrequency
Device Failures and Misuse Table 26.9 Food and Drug Administration (FDA) clas-
sification of medical devices with examples. According to
the FDA, device classification depends on the intended
Surgery requires the use of numerous supplies, use of the device and also upon indications for usea
instruments, and devices. According to the Food
CLASS I: low-risk devices
and Drug Administration (FDA), a ‘device’ is
• Tongue depressors
defined as, “an instrument, apparatus, imple-
• Bandages
ment, machine, contrivance, implant, in vitro • Handheld surgical instruments
reagent, or other similar or related article, includ- CLASS II: intermediate risk devices
ing a component part, or accessory which is: • Computed tomographic scanners
• Intravenous infusion pumps
• recognized in the official National Formulary, CLASS III: high risk devices
or the United States Pharmacopoeia, or any • Pacemaker leads and generators
supplement to them, • Internal cardioverter defibrillator leads and
• intended for use in the diagnosis of disease or generators
other conditions, or in the cure, mitigation, • Joint implants (e.g., hip, knee)
treatment, or prevention of disease, in man or • Heart valves
other animals, or • Coronary artery stents
• intended to affect the structure or any function • Ablation catheters (e.g., radiofrequency,
cryothermia)
of the body of man or other animals, and
• Robots
which does not achieve its primary intended
• Endoscopic instruments
purposes through chemical action within or on
Source: Jin [117]; Food and Drug Administration (FDA)
the body of man or other animals and which is [116]; Food and Drug Administration (FDA). Device
not dependent upon being metabolized for the product classification (search database). 2015. https://
achievement of any of its primary intended www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classi-
purposes” [116]. fication.cfm. Accessed 3 May 2016
a
Food and Drug Administration (FDA). Classify your
medical device. 2014. http://www.fda.gov/MedicalDevices/
The FDA distinguishes between chemical DeviceRegulationandGuidance/Overview/Classify
(i.e., pharmacologic) devices and those that alter YourDevice/. Accessed 3 May 2016
the structure or function of the body. It is this lat-
ter category that is discussed in this section. Although these hazards are seemingly ‘soft’ (and
Medical devices used in surgery are classified relate to software) they play an important role in
by the FDA according to the potential injury that the proper function of many devices (hardware)
may occur as a result of their use or misuse [117, that increasingly rely on electronic accuracy,
118]. Table 26.9 lists the FDA’s three classifica- maintenance, and safety [119]. Some specific
tions with examples of devices within each considerations for different devices are listed in
category. Table 26.10, Preventing Device-Related Never
Given the wide array of devices—some with Events.
associated energies (discussed earlier)—it is not It is not within the scope of this chapter to
difficult to see the associated risks, hazards, and present information on all the possible devices
dangers. The ECRI Institute publishes the ‘Top used in an OR, interventional suite, or other loca-
Ten Health Technology Hazards’ on an annual tion where operative and invasive procedures are
basis; the hazards published for 2015 [119] address performed, but there are general guidelines that
endoscope reprocessing, ventilator misconnec- apply to most, if not all situations.
tions, and insufficient training in robotics surgery. Part of the challenge clinicians face daily is the
Other hazards include alarms, missing data in elec- ever-changing technology. The key requirements
tronic health records, insufficient data security, and for the prevention of never events are to support
insufficient attention to updating software. and strengthen a culture that embraces continual
Table 26.10 Recommendations for preventing device-related never events

Device/risks Safety considerations
General recommendations for all • Adequate training of clinicians in OR technologies to reduce risk of
devices harm (ECRI 2016)
• Confirm that device is in proper working order
• Have backups available if there is device failure
• Employ the device for its intended purpose
• Use only FDA-approved devices
• Never silence device alarms
• Maintain in good working order with regular scheduled biomedical
engineering maintenance checks
• Know how to trouble shoot problems, or, whom to contact
• Remove from service when not functioning; send for repair or
replacement promptly
• Provide education material to patients and family members
• Install manufacturer’s software updates promptly and verify that most
current update is installed
• For implants stocked on consignment (and may not be documented in
the purchase history), ensure that they can be identified if there is a
product recall
Light sources (endoscopic):
• Burns • Connect light cable before activating light (applies also to surgical
head lights)
• Use standby mode when not in use
• Avoid placing cables with light activated on patient drapes
Endoscopic instruments
• Infection • Keep scopes wiped free of gross blood and body fluid during surgery
(inner and outer surfaces)
• Ensure initial cleaning in the OR suite
• Ensure adequate reprocessing
• Communicate actively and clearly with reprocessing staff about the
precise steps required for cleaning and reprocessing
Defibrillator
• Failure to discharge (e.g., due to • Ensure adequate 1) battery or 2) in-line power. If defibrilating, ensure
depleted battery power) that the device is NOT in the synchronous mode (device will look for a
nonexistent QRS and will not discharge); if cardioverting, ensure that
the ECG waveform is in the synchronous mode (will not discharge
without linking to a QRS waveform)
• Joules setting too high or too low • Confirm defibrillation setting depending on whether internal (e.g.,
10–20 Joules) or external (e.g., 400 Joules), and times of discharge
• Failure to defibrillate due to • Apply defibrillation external patches so that energy crosses the heart
external pad misplacement (e.g., (e.g., one padplaced on upper right chest above clavicle, and second
energy does not cross heart) pad placed on lower left chest in mid-axilary line)
Implantable Cardioverter-Defibrillator
• Inadvertent shocks • Check leads, generator, and accessories for integrity of the components
(e.g., no insulation tears or fractures, tight connections)
• Malfunction or cessation of function • Coordinate use of electrosurgery with pacer testing
• Be prepared to defibrillate with external defibrillator (apply external
defibrillator pads to chest preoperatively)
• Fractured leads or broken • Avoid injuring devices with surgical instruments (e.g., knives, forceps)
insulation
(continued)
Device/risks Safety considerations
Pacemaker
• Interference or injury from ESU • Check leads, generator, and accessories for integrity of the components
(e.g., no insulation tears or fractures, tight connections)
• Coordinate use of electrosurgery with pacer testing
• Fractured leads or broken • Avoid injuring devices with surgical instruments (e.g., knives, forceps)
insulation
Prosthetic Implants (e.g., joint prostheses, heart valves, ophthalmic implants, cosmetic [e.g., breast], other)
General recommendations for all • Store in conditions approved by manufacturer
prosthetic implants • Verbally confirm type, size, model, and other specific identification
aspects of implant requested before opening product
• If implant/prosthesis is in storagesolution (e.g., glutaraldehyde), rinse
solution and prepare prosthesis according to manufacturer’s
instructions
• Document device lot number, size, type, and other information
required per policy
Robots
• ESU burns • Collaborate with biomedical engineering to ensure regular maintenance
checks of the robot
• RSI • Engage in training simulations to develop practices to avoid RSI
• Organ puncture • Be aware of the possibility of injury occurring outside the field of
vision; scan the entire field often
Infection • Collaborate with sterile processing personnel to ensure proper cleaning
of robot and accessories
General recommendations • Surgeons, nurses, anesthesia personnel, and other team members
should receive interprofessional and collaborative education and
training
• Employ simulation technologies forinitial training
Saws (bone) • Ensure that saw blade is inserted properly and securely; test to confirm
• After inserting blade, place battery powered saw in ‘safety’ mode and
confirm mode with another member of sterile team; if another kind of
power source (e.g., electrical) is used, ensure that saw is in safety mode
• When handing saw to surgeon, verbalize whether saw is “on” or in
“safety” mode
• Have backup saw available
Tourniquet • Pad tourniquet site
• Document and track time that tourniquet is employed
• Verbalize predetermined time periods elapsed under the tourniquet to
surgeon
X-Ray machines
• Excessive radiation • Monitor and document radiation exposure
• Use lead shields during procedures employing radiation
• Have qualified staff members use radiation devices (e.g., C-arms,
portable X-ray machines)
Source: AORN [101]; Hauser [118]; ECRI Institute. Top 10 Health Technology Hazards for 2015. A Report from Health
Devices. 2014. (The ‘Hazards’ for more current years are also available at the website). https://www.ecri.org/Pages/
SearchResults.aspx?k=top%20technology%20hazards%202015&Page=1&PageSize=20&Sort=relevance&mo=false.
Accessed 3 May 2016 (available for free; registration required); ECRI Institute. Top 10 Health Technology Hazards for
2016. A Report from Health Devices. 2015. (The ‘Hazards’ for more current years are also available at the website).
https://www.ecri.org/Pages/2016-Hazards.aspx. Accessed 6 May 2016 (available for free; registration required)
ESU electrosurgical unit, FDA Food and Drug Administration
learning, active communication (including solici- Other types of devices include implants.
tation of probable questions related to knowledge Prosthetic implants (e.g., joints, cardiac valves,
deficits about new devices), and team training. A or blood vessels) often have implant-specific
study by Pisano, Bohmer, and Edmondson pub- accessories and instrumentation that cannot be
lished in 2001 [120] showed that the successful exchanged with other device accessories.
introduction of that new technology (with signifi- Selecting the appropriate sizing obturators,
cantly new and different devices) relied not only gauges, or other measuring instruments for the
on cumulative experience (i.e., the volume/num- surgeon to use in determining the most appropri-
ber of cases performed), but also on organiza- ate implant is not only a crucial safety factor but
tional, collective learning. The amount of also an important factor in the successful out-
experience was necessary but it was not sufficient. come of the procedure for the patient. The proper
Other factors played a key role. Successful inno- function of the device is the responsibility of the
vators in the study illustrated the attributes of entire surgical team—not just the surgeon per-
team cohesion, the importance of previous posi- forming the procedure and using the device.
tive interactions among team members, a high
degree of communication and cooperation among
departments before and during the learning ifficult Airway, Failed Airway, Air
D
period, frequent and robust communication and Embolus
explanation of the surgery and the techniques by
the surgeon as well as by other team members, Adverse events affecting the airway are not only
and standardization of the terms to be used during of primary concern to anesthesia personnel, but
surgery [120]. These actions served not only to to all members of the surgical team [121–126].
educate the staff about the specific technology, Events that affect the patient’s airway and gas
but also to provide a clear framework for discus- exchange were among the top ten priority safety
sion and clarification, and a strong foundation for issues identified by perioperative nurses [6, 19]
creating a cohesive team. and were cited among the most critical crises by
Initiating new techniques employing new Arriaga et al. [121] in their series of operating
devices is challenging, but device safety is appli- room crises. Some specific considerations for air-
cable also to the more mundane daily aspects of way difficulties and air embolus are listed in
surgery. Not to be underappreciated is the impor- Table 26.11, Recommendations for Reducing
tance of ensuring, for example, that the tips of Difficult Airway and Failed Airway Never
forceps (‘pick-ups’) meet, that scissors cut Events.
cleanly, and that needle holders hold needles Airway difficulties may be especially chal-
securely. The scrub person plays a vital role in lenging in small hospitals, ambulatory surgery
checking the working order of instruments. One centers (ASCs), and physicians’ offices where
need not assume that dull scissors will go unno- there are fewer resources (e.g., emergency air-
ticed by the surgeon; the value of the scrub per- way supplies and devices, medications, person-
son’s scrutiny of instruments cannot be nel) [19]. Unfortunately, not all airway
overstated. difficulties can be anticipated and are not treated
Confirming that devices such as laparoscopic appropriately in the absence of a coordinated
insufflators, electrosurgical units (ESU), defibril- response, specialized airway equipment, and clini-
lators, and saws are working properly is one of cal expertise. Additionally, there may be an
the crucial safety roles of the circulating RN as assumption that ‘ambulatory’ patients are other-
well as the scrub person. Nonworking ESUs (and wise healthy and low-risk surgical candidates
instruments) are important examples of device- [19]; such a presumption may prevent adequate
related events that are unlikely to occur with contingency planning and preparation for an
proper examination of these devices. adverse event.
Table 26.11 Recommendations for reducing difficult vocal cords during multiple attempted laryn-
airway and failed airway never events
goscopies, and being unable to intubate the tra-
• Identify potential risks for difficult or failed airway chea after multiple attempts. Additional
• Assessment patient preoperatively for potential interventions may include repositioning the
airway-related risks: (e.g., short, thick neck; large
tongue; patient unable to extend neck; shape of
patient, checking the equipment (e.g., confirm-
palate; inability to visualize palate or uvula; past ing the integrity of the anesthesia circuit),
airway issues) changing laryngoscopic blades, performing
• Review emergency policies and procedures, nasal intubation, or using additional intubating
including a failed airway protocol devices (e.g., stylet, light wand, video laryn-
• Create Difficult Airway Cart or other mobile goscopy) [122, 123, 126]. If, after these maneu-
storage container
vers and attempting to employ a supraglottic
• Provide imaging resources (e.g., video
laryngoscopy, bronchoscopy, echocardiography) airway device, [126–128] the patient’s oxygen-
• Identify personnel to support perioperative teams ation status remains abnormal, the anesthesiol-
• Practice emergency scenarios that include all ogist can consider the following actions:
members of the surgical team
• Develop annual (or more frequent) hands-on • Awaken the patient to resume spontaneous
displays for all team members of emergency breathing.
airway devices, imaging equipment, techniques of
emergency airway management, and related • Create a surgical airway.
activities
Source: American Society of Anesthesiologists [124];
Mort [127]; Wadlund and Seifert [128] Failed Airway
Preparing to create a surgical airway indicates

In addition to specific interventions described there is a failed airway. This situation may be
later, it is important to promote collaborative reflected by the following anesthetic consider-
practices, develop specific procedural interven- ations [123]:
tions and policies, and have necessary equipment
and supplies available—ideally in a ‘difficult air- • Unable to intubate on three attempts by a
way cart’ or tool case. Adverse outcomes include skilled and experienced provider.
death, neurologic injury, and cardiac arrest, as • Unable to maintain SaO2>90 % with bag ven-
well as trauma to the airway, damage to the teeth, tilating mask (BVM) after failure to achieve
and the creation of an unnecessary surgical air- oral intubation.
way [126]. • “Can’t intubate, can’t oxygenate” situation.
At this point (or earlier) there would likely have

Difficult Airway been a call to the surgeon as well as a call for addi-
tional help; emergency airway supplies and instru-
There is no standard definition of a ‘difficult ments would have been brought into the OR. While
airway’ according to the American Society of the tracheostomy instrument set is opened, the cir-
Anesthesiologists (ASA). However, difficulty culating nurse (or resident or other available staff
with facemask ventilation of the upper airway member) would cleanse the neck and upper chest
or difficulties intubating a patient—with result- while the surgeon scrubbed and gowned in prepa-
ing inadequate oxygenation—are defining ration for performing the tracheostomy.
components of a ‘difficult airway,’ according to After resolution of the patient’s emergency,
the ASA [126]. Early considerations include it can be useful to engage in a debriefing con-
determining if there is an inadequate facemask ference, a formal root cause analysis, or some
seal or excessive resistance to gas flow (in or other standardized method of reviewing what
out) in the patient, being unable to visualize the occurred, the patient’s outcome, what could
have been improved (or not), and what recom- an intravenous (IV) line or a central venous pres-
mended changes result from close scrutiny of sure (CVP) line, or during laparoscopic insuffla-
the event. Emergencies cannot always be pre- tion [129–131]. Conditions required for this to
vented; each team member’s duty is to prepare occur include (1) an open pathway between the
to respond to emergencies in a competent, col- source of air and the venous system, and (2) a
laborative, and proactive manner, which can pressure gradient of higher atmospheric pressure
reduce the number of potential subsequent favoring the passage of air into the lower pressure
never events. Table 26.11 describes additional venous circulation [129]. Of special concern is
recommendations related to difficult airway during neurosurgery when the venous anatomy
and failed airway events. poses some risk for VAE because the major cere-
bral venous sinuses, for example, do not collapse
and may remain ‘open,’ thus creating a pathway
Air Embolus for air movement down the pressure gradient.
A VAE also can migrate to the right ventri-
Airway emergencies affect oxygenation. Air cle and into the pulmonary circulation increas-
emboli—venous or arterial—also risk adequate ing pulmonary artery (PA) pressure; this can
oxygenation via the introduction of atmospheric produce pulmonary outflow tract obstruction.
air or surgical gases (e.g., carbon dioxide/CO2, Subsequently, pulmonary venous return is
nitrous oxide, nitrogen, helium) into the circula- reduced to the left side of the heart, resulting in
tory system where the embolus becomes wedged reduced cardiac output [130, 131]. In patients
in an artery or vein, thereby obstructing distal with suspected air emboli originating from an IV
flow [129]. or CVP line, anesthesia personnel, surgeon, and/
Signs and symptoms of air embolus, which or circulating nurse would check the intravascu-
may include decreased end-tidal CO2 and lar catheter(s) for possible entry sites of air and
reduced oxygen saturation are commonly first close off the entry point. Aspiration of air from a
noted by anesthesia professionals. Additional CVP line may be attempted; closing the source of
signs and symptoms include shortness of breath; air entry may require filling the surgical site with
pain in the chest, back, or shoulders; mental sta- irrigation. The scrub person can provide irriga-
tus changes; seizures; hypotension; acute pul- tion to the surgeon for sealing off the entry point
monary shunting producing hypoxemia and of air within the surgical wound [131–134].
hypercarbia; tachy- or bradyarrhythmias; and Placing the patient with the left side down and
cardiac arrest [129, 130]. in slight Trendelenburg will allow air to collect in
After recognizing the early signs of an air the apex of the right ventricle where it can be
embolus (e.g., decreased end-tidal CO2 and aspirated if the chest is open (e.g., during cardiac
lower oxygen saturation), the anesthesiologist surgery). Another action is to increase venous
would call for assistance: personnel and emer- pressure with IV volume, thereby reducing the
gency supplies and equipment. Transesophageal air pressure gradient favoring air entry. Lowering
echocardiography (TEE) and precordial the surgical site below the level of the heart also
Doppler ultrasound may be used also to detect has been used to prevent further air entry.
air emboli. Restoring hemodynamic stability
and restoring normal oxygen saturation is the rterial Air Embolus
A
goal and the anesthesia provider will increase An arterial air embolus (AAE) can occur during
the FiO2 to 100 % and stop nitrous oxide anes- cardiac surgery when air bubbles remain in the
thetic (if used) [130]. arterial inflow line or the cardiac chambers after
the heart resumes contractions, or, as a result of
enous Air Embolus
V chest trauma when air from, for example, the
A venous air embolus (VAE) is produced when bronchial veins can enter the left atrium. An AAE
gas enters the venous circulation, commonly via can also occur when venous air passes through a
cardiac defect such as a patent foramen ovale and lead to a possible failure to receive appropriate
enter the arterial circulation; this can occur when therapy. Ultimately these errors may create a lack
right atrial pressure is higher than left atrial pres- of confidence in the quality of the facility and in
sure, producing a right-to-left shunt [129, 130, the providers who are delivering care [19].
132, 133]. Arterial air emboli going to the func- One of the challenges in developing improve-
tional end arteries of the coronary circulation or ment strategies is that there is currently no
the brain can be especially dangerous because national database for evidence about incidence of
these organs are highly susceptible to injury after specimen error. Makary and colleagues [137]
only brief periods of hypoxia [130, 132]. reviewed surgical patient encounters in a large
Administering 100 % oxygen can improve east coast academic hospital and identified 91
oxygen saturation and increase the partial pres- surgical specimen errors in a 6-month period.
sure of oxygen and nitrogen within the blood, Surgical specimen identification errors were
causing the nitrogen to separate from the embolus defined as specimens not labeled; empty speci-
and move into the bloodstream. It is important to men container(s); no patient name; missing tissue
minimize the nitrogen content in the blood site; and incorrect or missing documentation of
because nitrogen can increase the size of the air laterality, tissue site, or patient identification.
bubbles; turning off a nitrous oxide anesthetic (if In 2013, Steelman, Graling, and Perkhounkova
used) is an important component of treatment [6] surveyed AORN members to identify high
[131]. Infusing vasopressors (e.g., dobutamine, priority patient safety issues. Of the over 3000
norepinephrine) to strengthen myocardial con- respondents, 35 % rated specimen errors as high
tractility and performing chest compressions priority. Percentages were similar across settings
(even when the patient is not in cardiac arrest) and hospital type but higher in larger hospitals
can break up large blocks of air and facilitate (over 100 beds); these findings may reflect the
their dispersal. Hyperbaric oxygen therapy may complexity of surgery and number of specimens
be provided in more severe cases once the patient per procedure in tertiary care centers.
is stabilized [135, 136]. A plan for transferring a Accurate specimen management requires
patient to a hyperbaric chamber should be part of effective multidisciplinary communication, mini-
any emergency protocol. mizing distractions, and an awareness of oppor-
The most effective way to avoid arterial (or any) tunities and risks for error. Barriers to optimal
air embolus is to be observant of entry sites into the specimen management include communication
vascular system and prevent the introduction of air. issues, time pressure, interruptions, and using
This is an obvious but important recommendation preprinted labels from another patient (e.g., left
that should be emphasized often. For example, the in the OR from a previous patient) for the patient
scrub person and surgical assistant(s) participating currently undergoing surgery. Although specific
in establishing cardiopulmonary bypass play an steps for handling various types of specimens
important role in observing for air bubbles when may differ, the management process is similar
arterial tubing connections are made, or, when and the basic requirements (correct identification
clearing air bubbles from any line before infusing of patient and specimen site) are essentially the
fluids into the arterial system. same ([138], p. 560).
Although there are few national guidelines and
other resources to help prevent specimen errors,
Surgical Specimen Never Events one exception is AORN’s Guideline for Specimen
Management [139], which provides a number of
Errors in the management of surgical specimens robust resources. The guideline addresses the fol-
are important never events because they can lead lowing critical specimen processes:
to delays in care due to inaccurate or incomplete
diagnosis, require reoperation to retrieve a new –– Conducting a needs assessment
specimen to replace one that has been lost, and –– Site identification
Table 26.12 Recommendations for reducing specimen tion, coagulopathy, and possible cardiac injury
never events
related to preoperative shivering (in patients with
• Ensure communication, assess need for obtaining heart disease) which increases myocardial oxy-
specimen, utilize processes such as check back for
gen demand [85, 140]. Additionally, hypothermia
confirmation (e.g., Teamstepps)
• Eliminate distractions and multitasking during
has been associated with altered drug metabo-
receipt, description, and confirmation of specimen lism, prolonged recovery after surgery, and gen-
• Label specimens accurately; use two unique eral discomfort [141–143]. Complications related
identifiers (e.g., patient’s name, medical record to hypothermia cannot only cause suffering and
number, and/or date of birth) severe complications but also extend length of
• If using a preprinted label, verify accuracy of stay and increase costs [144].
information as it is used; ensure unused labels are
removed at end of procedure The use of surgical care bundles in certain
• Utilize debriefing or Sign-Out time before patient patient groups (e.g., undergoing colorectal sur-
leaves the OR for identifying specimens with gery) [145] that include measures to maintain
surgeon, confirming specimen is correctly labeled, normothermia has shown a significantly
with correct patient’s name, and—if required—in
reduced risk of SSI. Perioperative personnel
appropriate fixative ([23], p. 492)
• Before removing specimens from the OR, two
should evaluate patients at risk for unplanned
people should identify the label and contents hypothermia and implement strategies such as
• Follow facility policies for documentation (e.g., temperature monitoring and patient warming to
surgeon confirms specimen list, signs specimen adjust environmental conditions according to
request form) patient needs [87].
Source: Haynes et al. [23]; Steelman and Graling [19]; A growing number of evidence-based
TeamSTEPPS. Agency for Healthcare Research and
resources are available to clinicians. These
Quality. http://www.ahrq.gov/professionals/education/
curriculum-tools/teamstepps/index.html. Accessed 3 May include AORN’s Guideline for Prevention of
2016; Van Wicklin [138] Unplanned Perioperative Hypothermia [87] and a
recently developed ‘Tool Kit’ [146, 147] that
contains templates for electronic medical record
–– Collection and handling documentation and Healthcare Failure Mode
–– Transfer from the sterile field Effect Analysis (HFMEA), an educational slide
–– Containment show on ‘best practices,’ a 10-Step implementa-
–– Specimen identification and labeling tion plan, references, and other components.
–– Preservation Recommendations include ‘prewarming’ the
–– Transport patient before the start of surgery; Vanni and col-
–– Disposition of the specimen leagues’ work [148] demonstrated benefits of
–– Documentation both prewarming (before surgery) as well as
warming during surgery. In an editorial discuss-
The guideline also addresses special care and ing perioperative temperature management, the
management (e.g., optimizing fixation and pres- author [149] cited studies [150, 151] as well as
ervation) of specific specimens: breast cancer personal experience supporting the efficacy of
specimens, forensic specimens, radioactive spec- preoperative warming.
imens, and orthopedic hardware. Some specific The mechanism of warming (e.g., passive or
recommendations for reducing specimen never active warm air) and the delivery method (e.g.,
events are listed in Table 26.12. mattress, air tube) has been studied more inten-
sively with the increasing ability to exert more
control over body temperature and the increased
Hypothermia scrutiny given to temperature thermally related
complications. Bender et al. [152] compared
Numerous studies have shown that hypothermia newer methods of passive warming to traditional
(less than 36.00 °C; normal, 37.00 °C) increases methods. Use of the newer devices, which employ
the incidence of complications: surgical site infec- nylon and polypropylene material that is wrapped
around the patient’s extremities and support the Table 26.13 Recommendations for reducing hypothermia-
related never events
head and body, showed improved maintenance of
core body temperature. The authors showed that General considerations
the newer passive devices complemented active • Educate staff about the pathophysiology of
inadvertent hypothermia
warming devices [152].
• Differentiate (e.g., indications, methods of
It is important to understand how and why promotion or prevention, techniques) between the
perioperative hypothermia can occur. Steelman need for intentional hypothermia (associated with
and Graling [19] stress that the goal is to focus on cardiac surgery) and avoidance of unintentional
patient outcomes; although compliance with pro- hypothermia
cess measures and metrics is not unimportant, the • Make patient outcome metrics an integral part of
the quality improvement program
primary concern is the result of the patient’s sur-
• To prevent burns, use extreme caution with forced
gical experience. Additional recommendations warm air devices; ensure that temperature of the air
for maintaining perioperative normothermia are is within acceptable limits
presented in Table 26.13. Preoperatively
• Employ active prewarming procedures (for at least
30 min)
I nstrument Care and Reprocessing • Do not rely on warm blankets to prevent
hypothermia (but do not deny a patient’s request
Never Events for a “warm blanket”)
Intraoperatively
The complexity of current instruments and • Prewarm fluids (e.g., intravenous, irrigating);
devices challenges the most scrupulous clinicians exception: during cardiac surgery, if irrigating
and sterile processing professionals. The design during period of induced cardiac arrest, ensure that
of many instruments—especially those with mul- temperature of irrigating fluid is cold; when
patient’s temperature is normothermic, use warm
tiple lumens—makes thorough cleaning even irrigation.
more difficult. In facilities with fewer human • Employ active prewarming procedures (before
resources, there are additional challenges. The induction of anesthesia)
Top 10 Health Technology Hazards for 2015, • When employing forced air warming (FAW)
published by ECRI ([119], p. 2), lists “inadequate through a hose, ensure that air is going into the
FAW blanket and not directly onto the patient’s
reprocessing of endoscopes and surgical instru- skin in order to prevent patient burns
ments” as the number #4 hazard. Postoperatively
Greater public awareness of reprocessing dif- • Maintain active warming procedures
ficulties and shortcomings has encouraged • Do not rely on warm blankets to prevent
greater oversight by a number of organizations, hypothermia (but do not deny a patient’s request
most notably the Association for the Advancement for a “warm blanket”)
of Medical Instrumentation (AAMI) [153], the Source: Steelman and Graling [19]; AORN [87]; AORN.
Centers for Disease Control and Prevention Prevention of perioperative hypothermia (PPH) tool kit.
AORN. https://www.aorn.org/aorn-org/guidelines/clinical-
(CDC) [154], the Association for Professionals in resources/tool-kits/prevention-of-perioperative-hypothermia-
Infection Control and Epidemiology (APIC) pph-tool-kit. Accessed 3 May 2016
[155], and AORN [156–158].
There is also a greater incentive for peri- Recommendations for the care, cleaning, and
operative clinicians to actively partner not reprocessing of endoscopes and other instru-
only with their sterile processing colleagues, ments and devices are available from many
but also with Infection Preventionists and sources: ECRI [119], CDC [154], AORN [156–158],
Risk Management personnel. Perioperative and individual experts [159]. Effective strategies
staff who may have been hesitant in the past for preventing reprocessing never events are
to invite Infection Prevention colleagues into listed in Table 26.14.
the OR setting, can benefit by collaborating to There are multiple resources available for infor-
solve issues jointly and effectively. mation and guidance related to never events; these
Table 26.14 Strategies for preventing reprocessing never events

Before surgery starts (setup)
• Scrub person confirms sterility of instruments sets, individually sterilized instruments, and supplies
• Scrub person checks instrument lumens, teeth, box locks, security of screws, and freely moving parts to ensure
no bio burden or other material on/in instruments
During surgery
• Scrub person keeps instruments clean (e.g., with moistened sponge); bioburden and debris that is allowed to dry
may be very difficult to remove; sterile H2O is recommended for cleaning instruments (scrub person must
ensure that container with water is labeled)
• Assistant may use moist sponge to keep personal forceps and suture scissors clean and free of debris
At the completion of surgery
• Perform initial cleaning of instruments before leaving OR
• ‘Tag’ and remove damaged and/or nonworking instruments
• Presoaking with appropriate product is recommended
After surgery
• Use only approved cleaning solutions (do not place instruments in chlorine bleach!)
• Rearrange instruments in order on stringers
• Protect delicate instruments
Sterile processing
• Instruments that are not ‘clean’ cannot be disinfected or sterilized
• Follow manufacturer’s instructions for cleaning, disinfecting, and sterilizing
• Have tools appropriate for cleaning (e.g., lumens, jaws, teeth)
• Reorganize instruments and prepare for sterilization with care to avoid injury to instruments
• Have instrument cleaning accessories recommended by the manufacturer
• Protect delicate instruments
Source: ECRI Institute. Top 10 Health Technology Hazards for 2015. A Report from Health Devices. 2014. (The
‘Hazards’ for more current years are also available at the website). https://www.ecri.org/Pages/SearchResults.
aspx?k=top%20technology%20hazards%202015&Page=1&PageSize=20&Sort=relevance&mo=false. Accessed 3
May 2016; ECRI Institute. Top 10 health technology hazards for 2016. https://www.ecri.org/Pages/2016-Hazards.aspx.
Accessed 3 May 2016; ECRI Institute. Top 10 patient safety concerns for 2016. https://www.ecri.org/Pages/Top-10-
Patient-Safety-Concerns.aspx. Accessed 3 May 2016; AAMI [153]; APIC [155]; AORN [156, 158]; Cowperthwaite and
Holm [157]; Seavey [159]
are listed in Table 26.15. These resources reflect events, but clinicians should appreciate even more
organizations as well as specific publications the importance of sharing information, helping
related to never events in particular and safe, effec-
others to succeed, and always looking for better
tive care in general. ways to improve and to measure—in other words
engaging in effective communication.
Although the Institute of Medicine’s report,
Conclusions To Err is Human [10], became a landmark publi-
cation that focused the public’s attention on the
A recent systematic review [9] looking at three prevention of error and the promotion of safety,
never events occurring during surgery—wrong- there were earlier, notable attempts to identify
site surgery, retained surgical items, surgical errors and initiate methods to prevent repeating
fires—found limited evidence of effective inter- those errors. Almost 100 years ago, Harvey
vention other than improved communication. The Cushing, MD, Johns Hopkins neurosurgeon, cat-
results may seem disconcerting to those wishing alogued and analyzed his mistakes in one of the
for a magic ‘silver bullet’ that will prevent never earliest examples of documenting, reporting,
Table 26.15 Resources to address perioperative never events
Resources to address the highest priority perioperative patient safety issues
Safety issue Resources
1. Patient 1. AORN, http://www.aorn.org
misidentification: • Correct Site Surgery Tool Kit, http://www.aorn.org/guidelines/clinical-resources/
preventing wrong tool-kits/correct-site-surgery-tool-kit
site/procedure/ • Position statement on preventing wrong-patient, wrong-site, wrong-procedure events,
patient surgery https://www.aorn.org/aorn-org/guidelines/clinical-resources/position-statements
• Webinars, https://www.aorn.org/search#q=webinars
2. Joint Commission, http://www.jointcommission.org/
3. World Health Organization, http://www.who.int/en/
4. Institute for Healthcare Improvement, http://www.ihi.org/Pages/default.aspx
5. Agency for Healthcare Research and Quality, https://psnet.ahrq.gov/
6. National Guideline Clearinghouse, http://www.guideline.gov/
7. National Quality Forum, http://www.qualityforum.org/Home.aspx
2. Preventing 1. AORN, http://www.aorn.org
medication errors • Guideline for medication safety. In: Guidelines for perioperative practice. Denver,
CO: AORN, Inc.; 2016:289–328
• Clinical FAQs, http://www.aorn.org/aorn-org/guidelines/clinical-resources/
clinical-faqs
3. Institute for Healthcare Improvement, http://www.ihi.org/Pages/default.aspx
6. Anesthesia Patient Safety Foundation, http://www.apsf.org/
7. Institute for Safe Medication Practices, http://www.ismp.org/
8. US Food and Drug Administration, http://www.fda.gov/
9. US Pharmacopeia, http://www.uspharmacopeia.com/
pressure injuries • Guideline for positioning the patient. In: Guidelines for Perioperative Practice.
Denver, CO: AORN, Inc.; 2016:649–668
• AORN Tool Kit. Safe patient handling and movement in the perioperative setting.
https://www.aorn.org/aorn-org/guidelines/clinical-resources/tool-kits/
safe-patient-handling-tool-kit
2. American College of Surgeons (ACS), Statement on older adult falls and falls
prevention, https://www.facs.org/about-acs/statements/73-older-falls
5. Wound Ostomy and Continence Nurses Society, http://www.wocn.org/#
surgical site • Guideline for environmental cleaning. In: Guidelines for Perioperative Practice.
infection Denver, CO: AORN, Inc.; 2016:7–28
• Guideline for hand hygiene. In: Guidelines for perioperative practice. Denver, CO:
AORN, Inc.; 2016:29–40
• Guideline for preoperative patient skin antisepsis. In: Guidelines for perioperative
practice. Denver, CO: AORN, Inc.; 2016:41–64
• Guideline for sterile technique. In: Guidelines for perioperative practice. Denver, CO:
AORN, Inc.; 2016:65–94
4. Association for Professionals in Infection Control and Epidemiology (APIC), http://
www.apic.org/
5. Surgical Care Improvement Project (SCIP), http://www.jointcommission.org/
surgical_care_improvement_project/
(continued)
electrical and • AORN Guideline for environment of care, Part 1. In: Guidelines for perioperative
other energy- practice. Denver, CO: AORN, Inc.; 2016:237–262
related injuries • AORN. Guideline for electrosurgery. In: Guidelines for perioperative practice.
• AORN. Guideline for laser safety. In: Guidelines for perioperative practice. Denver,
CO: AORN, Inc.; 2016:137–150
• AORN. Guideline for minimally invasive surgery. In: Guidelines for perioperative
practice. Denver, CO: AORN, Inc.; 2016:589–616
• Ball KA. Surgical modalities. In Rothrock JC, editor. Alexander’s care of the patient
in surgery. 15th ed. St Louis: Elsevier Mosby; 2013. p. 211–252
• Seifert PC, Peterson E, Graham K. Crisis management of fire in the OR. AORN J.
2015;101(2):250–263
• Fire Safety Tool Kit, https://www.aorn.org/aorn-org/guidelines/clinical-resources/
tool-kits/fire-safety-tool-kit
3. ECRI Institute, https://www.ecri.org/
5. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Fundamental
use of surgical energy (FUSE). (Registration [free] required). http://www.fusedidactic.
org/. Accessed 2 May 2016
retained surgical • Guideline for prevention of retained surgical items. In: Guidelines for perioperative
items practice. Denver, CO: AORN, Inc.; 2016:369–415
• Goldberg JL, Feldman DL. Implementing AORN recommended practices for
prevention of retained surgical items. AORN J. 2012;95(2):205–216
• Steelman VM, Cullen JJ. Designing a safer process to prevent retained surgical
sponges: a healthcare failure mode and effect analysis. AORN J. 2011;94(2):132–141
7. Preventing device 1. AORN, http://www.aorn.org
failures and • Guideline for environment of care, Part 1. In: Guidelines for perioperative practice.
misuse Denver, CO: AORN, Inc.; 2016:237–262
• Guideline for electrosurgery. In: Guidelines for perioperative practice. Denver, CO:
AORN, Inc.; 2016:119–136
• Guideline for laser safety. In: Guidelines for perioperative practice. Denver, CO:
AORN, Inc.; 2016:137–150
2. National Quality Forum, http://www.qualityforum.org
3. ECRI Institute, https://www.ecri.org
4. Individual manufacturer’s instructions
5. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Fundamental use
of surgical energy (FUSE). (Registration [free] required). http://www.fusedidactic.org/
(continued)
8. Responding to 1. AORN, http://www.aorn.org
difficult • Wadlund DL, Seifert PC. Crisis management of failed airway in the OR.
intubation/airway AORN J. (2015);102(4):413–423
emergencies, air • Seifert PC, Yang Z, Munoz R. Crisis management of air embolism in the OR. AORN
embolus J. (2015);101(4):471–481
2. American Society of Anesthesiologists, http://www.asahq.org/
3. American Association of Nurse Anesthetists, http://www.aana.com
9. Preventing 1. AORN, http://aorn.org
specimen • Guideline for specimen management. In: Guidelines for perioperative practice.
management Denver, CO: AORN, Inc.; 2016:441–470
never events 2. Department of Veterans Affairs, National Center for Patient Safety, Healthcare Failure
Mode and Effect Analysis (HFMEA)
• The Basics of Healthcare Failure Mode and Effect Analysis. Washington, DC:
Veterans Health Administration; 2001. http://www.patientsafety.va.gov/professionals/
onthejob/hfmea.asp
perioperative • Guideline for prevention of unplanned perioperative hypothermia. In: Guidelines for
hypothermia perioperative practice. Denver, CO: AORN, Inc.; 2016:531–554
• Prevention of Perioperative Hypothermia Tool Kit https://www.aorn.org/aorn-org/
guidelines/clinical-resources/tool-kits/
prevention-of-perioperative-hypothermia-pph-tool-kit
• Clinical FAQs, http://www.aorn.org/clinicalfaqs
2. Anesthesia Patient Safety Foundation, http://www.apsf.org
3. American Society of PeriAnesthesia Nurses, http://www.aspan.org/
• Hooper VD, Chard R, Clifford T, et al. ASPAN’s evidence-based clinical practice
guideline for the promotion of perioperative normothermia: second edition.
J Perianesth Nurs. 2010;25(6):346–365
4. National Quality Forum, http://www.qualityforum.org
6. Surgical Care Improvement Project (SCIP), http://www.jointcommission.org/
surgical_care_improvement_project/
11. Preventing 1. AAMI, http://www.aami.org
failures in • FDA beefs up reprocessing guidance. September 2015. http://www.aami.org/
instrument care productspublications/articledetail.aspx?ItemNumber=2735
and reprocessing 2. AORN, http://www.aorn.org
• Guideline for cleaning flexible endoscopes and endoscope accessories. In: Guidelines
for perioperative practice. Denver, CO: AORN, Inc.; 2016:675–758
• Guideline for high-level disinfection. In: Guidelines for perioperative practice.
• Guideline for instrument cleaning. In: Guidelines for perioperative practice. Denver,
CO: AORN, Inc.; 2016:773–808
• Sterile processing webinar series for ambulatory surgery centers, presented in
partnership with International Association of Healthcare Central Service Material
Management. https://www.aorn.org/Member_Apps/Product/Detail?productID=9452
• Clinical FAQs, http://www.aorn.org/aorn-org/guidelines/clinical-resources/
clinical-faqs
(continued)
5. ECRI Institute, https://www.ecri.org
6. Association for Professionals in Infection Control and Epidemiology (APIC), http://
www.apic.org/
7. Individual manufacturer’s instructions
Source: Steelman et al. [6]; Steelman and Graling [19]
All websites accessed 3 May 2016
7. Lingard L, Reger G, Orser B, Reznick R, et al.

improving, and innovating one’s practice by rec- Evaluation of a preoperative checklist and team
ognizing a human tendency to err and to learn briefing among surgeons, nurses, and anesthesiolo-
gists to reduce failures in communication. Arch
from those very errors [160]. In an address to the Surg. 2008;143(1):12–7.
New England Otological and Laryngological 8. Thiels CA, Lal TM, Nienow JM, Pasupathy KS,
Society in 1920, Cushing stated that “Errors will et al. Surgical never events and contributing human
be made, but it is from our mistakes, if we pursue factors. Surgery. 2015;158(2):515–21. doi:10.1016/j.
surg.2015.03.053.
them into the open instead of obscuring them, 9. Hempel S, Maggard-Gibbons M, Nguyen DK,
that we learn the most” ([161], p. 210). Cushing’s Dawes AJ, et al. Wrong-site surgery, retained surgi-
advice is as pertinent today as it was in 1920. cal items, and surgical fires: a systemic review of
surgical never events. JAMA Surg. 2015;150(8):796–
805. doi:10.1001/jamasurg.2015.0301.
10. Kohn LT, Corrigan JM, Donaldson MS. To err is
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Healthcare-Associated Infections
in Surgical Practice 27
Scott J. Ellner and Affan Umer
“One sometimes finds what one is not looking for.”

—Sir Alexander Fleming
belief is no longer compatible with modern medi-

Introduction cal practice. Federal institutions have tracked
HAI data through the National Nosocomial
Healthcare-associated infections (HAIs) pose a Infections Surveillance (NNIS) System since
significant burden to healthcare delivery systems, 1970, later succeeded by the National Healthcare
representing an active inefficiency in healthcare Safety Network (NHSN) [3]. Their impact on the
today. HAIs can be acquired during treatment sustainability of our healthcare delivery model
within any healthcare setting, be it acute care has brought our practice under considerable scru-
hospitals or post-acute rehabilitation centers tiny. In response, the Center for Medicare and
(http://health.gov/hcq/prevent-hai.asp). The Medicaid Services (CMS), starting October 1,
Center for Disease Control (CDC) 2011 surveil- 2008, pushed stringent measures to enforce its
lance data reports that 1 in 25 hospitalized vision of quality in healthcare. This shift in pol-
patients will acquire a HAI (http://www.cdc.gov/ icy meant that hospitals would claim limited
HAI/surveillance/#progress). To put this in per- reimbursement on HAIs such as catheter-
spective, it amounts to an estimated 722,000 associated urinary tract infections (CAUTIs),
HAIs in US acute care hospitals (http://www.cdc. catheter-related bloodstream infections
gov/HAI/surveillance/#progress) [1]. Not only (CRBSIs), ventilator-associated pneumonia
does this have a significant economic impact, (VAPs), and surgical site infections (SSIs), etc.
amounting to billions of dollars, it also represents As a result, institutions have been circuitously
one of the leading causes of preventable morbid- pressured into prioritizing reduction in HAIs.
ity and mortality [2]. Over the last few years, hospitals have aligned all
HAIs were historically perceived as an tiers of healthcare delivery to the value-based
inevitable consequence of patient care. This model by adopting evidence-based guidelines
from the CDC, for HAI reduction (http://www.
S.J. Ellner, DO, MPH, MHCM, FACS (*)
cdc.gov/HAI/prevent/prevent_pubs.html; http://
Centura Health Physician Group, Centura Health, www.cdc.gov/HAI/prevent/top-cdc-recs-
9100 Mineral Circle, Centennial, CO 80112, USA prevent-hai.html), and the results have been
e-mail: [email protected]; encouraging. Recent data from the Agency for
[email protected]
Healthcare Research and Quality (AHRQ) led by
A. Umer, MD the US Department of Health and Human
Department of Surgery, Saint Francis Hospital
and Medical Center, 114 Woodland Street,
Services (HHS) demonstrate a 17 % reduction in
Hartford, CT 06105, USA hospital-acquired conditions (HAC), including
e-mail: [email protected] HAIs (https://psnet.ahrq.gov/primers/primer/7).

450 S.J. Ellner and A. Umer
Quality is the new dictum in all specialties of 25 % in those who are colonized [9]. CAUTIs
healthcare. The American College of Surgeons cause unnecessary discomfort in patients, pro-
National Surgical Quality Improvement Program long hospital length of stay, and can be fatal,
(ACS-NSQIP) is in the forefront in its efforts to especially in the setting of urosepsis or systemic
prevent postsurgical complications, including bacteremia. Although CAUTIs are a relatively
HAIs. Although ACS-NSQIP reported data is inexpensive adverse event, with an average cost
confidential and available only to participating of $758 per infection [10], its high frequency of
institutions, there is increasing advocacy for pub- occurrence translates into a cumulative cost of
lic reporting of HAIs. The effect of measures millions of healthcare dollars [11]. Reduction in
such as public reporting remains unknown [4] but CAUTIs is a top priority for federal and state
some evidence suggests that it helps increase regulatory bodies, but despite a nationwide effort,
implementation of preventive protocols [5, 6]. there has been a 6 % increase in CAUTI rates
Therefore, the future will most likely mandate between 2009 and 2013 (http://www.cdc.gov/
greater transparency and could be critical to HAI/surveillance/#progress). Per NHSN data,
patient autonomy in choosing their healthcare CAUTI rates are highest in general surgery and
providers. To hospitals, this may sound counter- trauma ICU patients. Not surprisingly, these fig-
intuitive, but there is a strong belief among focus ures are congruent with high-indwelling urinary
groups, payers, and policymakers that account- catheter usage rates in surgical units (http://www.
ability in outcomes will accelerate improvement cdc.gov/nhsn/PDFs/dataStat/2010NHSNReport.
processes, as well as serve as an impetus for their pdf). The best preventive strategies, therefore, are
continuance. based around modifying catheter usage.
Surgeons, who historically have been most Risk factors for CAUTI include older age,
resistant to change, are rapidly embracing patient female sex, malnutrition, diabetes mellitus, renal
safety. They are aggressively addressing postop- insufficiency, ureteral stents, and inappropriate
erative HAIs, thus decreasing both hospital management of catheter draining system [7, 12].
length of stay and hospitalization costs. Most The microbiology of uncomplicated CAUTI con-
HAIs can be addressed through relatively inex- sists of gram-negative bacteria such as
pensive process improvement measures. Further Escherichia coli (most common), Klebsiella
innovation in Electronic Health Records (EHR) pneumoniae, and Proteus mirabilis [13]. A recent
systems, modification of nursing protocols, and analysis of HAIs found Enterococcus species as
patient education will assist preventive strategies the third most common cause of UTI [1]. Other
already in place. The responsibility lies with all prevalent organisms causing CAUTI include
healthcare providers to develop a patient centric Pseudomonas and various fungi; both found
culture in our dominion, meeting all benchmarks more commonly in postsurgical patients [14].
of quality. Only 10 % of patient with a CAUTI will have
symptoms, thereby making CAUTI diagnosis
difficult [15]. Bacteriuria is often present with
Catheter-Associated Urinary Tract indwelling catheter use, though it may not neces-
Infection (CAUTI) sarily mean an infection is present. The CDC
defined criteria for CAUTI diagnosis is shown in
Urinary tract infection (UTI) is the second most Table 27.1. Once a diagnosis is established, treat-
common type of HAIs. Approximately 80 % of ment revolves around targeted antibiotic therapy
UTIs are related to an indwelling urinary catheter and catheter removal. If the catheter cannot be
or instrumentation [7, 8]. After the first 48 h, the removed, it should be changed. However, with
risk of bacterial colonization increases by 5 % ongoing catheterization, a longer course of anti-
with each continuous day of catheterization. microbial therapy will be required and infections
Subsequent infection rates can reach as high as will likely recur despite adequate treatment [16].
27 Healthcare-Associated Infections in Surgical Practice 451
Table 27.1 Hospital-acquired infection (HAI) criteria

Hospital-acquired
infections (HAIs) Criterion
Catheter-associated 1. Patient has a urinary catheter in place for >48 h and was either;
urinary tract • Present for any duration on the day of infection OR
infection (CAUTI) • Removed the day before the date of event
(requires 1, 2, and 3) 2. Patient has at least one symptom or sign of UTIa
3. A positive urine culture (with no more than two species) of >105 colony forming units
(CFU)
Catheter-related 1. A positive blood culture with the same organism cultured from the catheter tip OR
blood stream Culture of the same organism from at least two blood samples (one from a catheter hub
infection (CRBSI) and the other from a peripheral vein or second lumen) meeting criteria for quantitative
blood cultures or differential time to positivity
2. Central line-associated bloodstream infection (CLABSI) is defined separately as a
laboratory-confirmed bloodstream infection in a patient with a central line within a 48-h
period
Surgical site • Infection occurs within 30 days (90 days for organ space infection) after the operation
infection (SSI) • Diagnosis is made by the surgeon (attending physician)
• Sign and symptoms of infection should be present on physicalb, radiological, or
histopathologic (positive culture) examination
• Superficial: only one is required
1. Purulent drainage, with or without laboratory confirmation, from the superficial incision
2. Organism is isolated from an aseptically obtained culture of fluid or tissue from the
superficial incision
3. Incision is deliberately opened by surgeon, unless incision is culture negative
• Deep: only one is required
1. Purulent drainage from the deep incision but not from the organ/space component of
the surgical site
2. A deep incision spontaneously dehisces or is deliberately opened by a surgeon
• Organ space: only one is required
1. Purulent drainage from a drain that is placed into the organ/space
2. Organisms isolated from an aseptically obtained culture of fluid or tissue in the organ/space
3. An abscess or other evidence of infection involving the organ/space that is found
Pneumonia • Hospital-acquired (or nosocomial) pneumonia (HAP) is pneumonia that occurs 48 h or
more after admission and did not appear to be incubating at the time of admission
• Ventilator-associated pneumonia (VAP) is a type of HAP that develops more than
48–72 h after endotracheal intubation
• Healthcare-associated pneumonia (HCAP) is defined as pneumonia that occurs in a
nonhospitalized patient with extensive healthcare contact
• Diagnosis requires appropriate clinical (fever, leukocytosis or leukopenia, or altered
mentation), radiological (chest X-ray or CT), and histopathological (blood, pleural
fluid, or bronchoalveolar lavage cultures) signs and symptoms
Clostridium difficile 1. The presence of diarrhea, defined as passage of 3 or more unformed stools in 24 or
infection (CDI) fewer consecutive hours AND/OR
2. A stool test result positive for the presence of toxigenic C. difficile or its toxins or
colonoscopic or histopathologic findings demonstrating pseudomembranous colitis
a
Fever (>38.0 °C), suprapubic tenderness, costovertebral angle pain or tenderness, urinary urgency, urinary frequency,
and dysuria
b
Pain or tenderness, localized swelling, redness, heat or fever (>38 °C), localized pain, or tenderness
catheters in operative candidates are used only

Prevention when necessary. It also includes aseptic inser-
tion techniques and vigilant assessment of
Effective CAUTI reducing strategies are necessity and removal of indwelling catheter
focused on minimizing catheter usage. This [17–19]. Additionally, there is strong evidence
involves staff education and training, so urinary in favor of maintaining closed drainage systems
and intermittent catheterization in non-ICU Table 27.2 Risk factors for catheter-related bloodstream
infection (CRBSI)
patients to minimize CAUTI risk [20]. However,
measures such as antibiotic prophylaxis during Operator Insertion circumstances and site,
operator experience, appropriate barrier
prolonged catheterization, bladder irrigation, or
precautions, skin antisepsis, duration of
external catheterization (in males) have shown catheter use, appropriate catheter
little benefit in reducing CAUTI, if none at all maintenance
[4]. Variable success has been reported with Host Age, comorbidities, malnutrition
silver-coated or medicated catheters, and rou- Device Multi-lumen CVCs, multiple CVCs,
tine use is not recommended at the moment. tunneled catheters
With over 30 % of catheters inserted for wrong Other Parenteral nutrition, prolonged
hospitalization, use of blood products,
indications, CAUTI reduction is still an uphill cardiac surgery
battle. Unfortunately, very often the females,
elderly, and disabled, who are all more likely to
develop an infection, are victims of this over- dine skin preparations [24]. The diagnosis of
sight. Preliminary 2014 data from the CDC CRBSI requires a positive blood culture with the
shows improvement in CAUTI incidence. same organism isolated from the catheter tip
Hopefully, a detailed look will shed light on what (gold standard) or a differential period of 2 h
measures were effective and enable infection between the initial positive blood culture and the
stewards to focus efforts in the proper direction. subsequent CVC culture which grew the same
organism (http://www.apic.org/Resource_/Elimi
nationGuideForm/259c0594-17b0-459d-b395-
Catheter-Related Bloodstream fb143321414a/File/APIC-CRBSI-Elimination-
Infection Guide.pdf). CLABSI is defined separately as a
laboratory-confirmed bloodstream infection in a
Approximately 3–16 % of intravascular catheter- patient with a central line within a 48-h period.
ization, depending on site of intervention and Additional details regarding diagnosis criteria are
type of catheter, can result in CRBSI [21]. These listed in Table 27.1.
infections can cause increased morbidity, excess It is important to note, as quality measures
hospitalization, and can be potentially fatal [22, are being adopted with greater frequency espe-
23]. The CDC data estimates 15 million central cially in ICUs, majority of the CRBSI/CLABSIs
venous catheter (CVC) days annually in US are occurring outside the ICU setting [27, 28].
intensive care units, 250,000 CRBSI (92,000 However, treatment remains the same. Systemic
central line-associated bloodstream infections— antibiotics and catheter removal are the key ele-
CLABSI) resulting in 62,000 deaths. The esti- ments in the management of CRBSI.
mated cost of treating a CRBSI ranges from Vancomycin is the recommended antibiotic for
$3000–$56,000 [24]. Bloodstream infections, empiric therapy [29]. This can be further tai-
especially those associated with CVC, are the lored depending on blood culture speciation.
costliest among HAIs; hence, a lot of quality Femoral catheters in critically ill patients
improvement work has been directed toward should receive empiric treatment for gram-neg-
their reduction. ative bacilli and fungi as well [30]. The dura-
Risk for CRBSI and CLABSI can be multifac- tion of treatment varies depending on severity
torial depending on the operator, host, and device, and pathogen. Uncomplicated infections gener-
Table 27.2. Majority of CRBSI are caused by ally require 5–14 days of antibiotics, while
gram-positive organisms (Staphylococcus spp., treatment for complicated CRBSI can stretch to
Enterococcus spp.) followed by gram-negative as much as 8 weeks. Multidrug-resistant organ-
bacilli and fungi (Candida spp.) [24–26]. Recent isms remain a serious issue; until recently 50 %
trends have showed lower rates of gram-positive of all S. aureus isolates in ICUs were methicil-
CRBSI owing to the commonly used chlorhexi- lin resistant.
Catheter removal should always be the prior- als continues regarding whether a benchmark of
ity in CRBSI unless unusual circumstances occur, 0 % is realistic or sustainable. A multidisciplinary
and an alternative site is not available [31]. Short- approach is favored with a focus on minimizing
term catheters should be removed in CRBSI due variability, zero tolerance for noncompliance,
to the presence of Staphylococcus aureus, and a commitment to internal accountability.
Enterococci, gram-negative bacilli, and fungi.
Long-term catheters should be removed in the
setting of severe sepsis, endocarditis, suppurative Surgical Site Infections (SSI)
thrombophlebitis, or persistent infection after
72 h of antimicrobial therapy [31]. According to a recent surveillance survey, surgi-
cal site infections are tied with pneumonia as the
most common HAI [1]. Despite over a decade of
Prevention effort to reduce surgical site infections, they still
remain a common occurrence. Approximately 40
Among all the HAIs, measures to reduce CRBSI million surgical procedures take place in the
have shown the most promise. Successful imple- United States annually and SSIs are expected to
mentation of catheter management protocol in occur in 2–5 % of postsurgical patients [38]. SSIs
both the Michigan Keystone ICU Project and the constitute 14 % of the total burden of HAIs and
Pittsburgh Regional Health Initiative has shown a 38 % of HAIs in surgical patients [39]. These
decrease of up to 70 % in CLABSI rates. Most of infections result in excess morbidity, hospital
these protocols adhere to best practice guidelines length of stay, and increased risk of readmission,
and are cost-effective, sustainable, and replica- and unlike CRBSI, their occurrence has a well-
ble. Generally, preventive algorithms are geared established link to increased mortality [40–42].
toward staff education for insertion and mainte- The risk of death is 2–11 times higher in infected
nance of catheters. The emphasis is on using patients as compared to those who are not
maximum barrier precautions [32], chlorhexidine infected. The cost of an average SSI is estimated
skin preparation [33], weekly dressing changes to cost between $6000 and $10,000 [43]. The
for central lines, and daily inspections for signs total cost of hospitalization can be up to 70 %
of infection. Scheduled simulation-based training higher in an admission with an SSI depending on
and educational modules are paramount to reiter- its severity [44].
ating these practices among healthcare person- The CDC has standardized definitions for
nel. In addition, checklists and electronic health SSIs, which vary depending on the depth of the
record system hard stops can aid in compliance. infection. They are further classified into superfi-
Recent data suggests promising results with anti- cial incisional, deep incisional, and organ space
microbial lock solutions [34, 35], antimicrobial SSI. Details of each are available in Table 27.1.
impregnated catheters [36], and chlorhexidine Multiple risk factors exist which can be host
dressings [37]. Use of antimicrobial ointments, dependent (extremes of age, obesity, diabetes
frequent catheter manipulation, and replacement mellitus, malnutrition, MRSA carriers, cigarette
increase colonization at the insertion site and are smoking, steroid use, and remote site infection)
best avoided. [45–52] or operation dependent (heavily depen-
The most important intervention is to assess dent upon the inherent risk of infection deter-
the need for intravascular access daily and mined by the class of wounds). Clean wounds
remove the catheter as soon as its purpose is have an SSI rate of 2 %, while dirty wounds can
served. have infection rates as high as 40 % [53].
CLABSIs have decreased by 56 % between Additional risk factors, depending on operative
2001 and 2009 and another 46 % by 2013. The choices, include preoperative shaving, chlorhexi-
gains have been remarkable, but the goal is to get dine skin preparation, preoperative showering,
to zero. The debate among healthcare profession- antibiotic prophylaxis, maintaining sterility,
operative room ventilation, intraoperative trans- Table 27.3 Preventive measures to reduce surgical site
infections (SSI)
fusions, and ultimately on the type and duration
of surgery [53–64]. Postoperative wound care Preoperative Tight glycemic control, treat
remote infections, optimize
provides additional opportunity to prevent infec-
nutrition, shorter preoperative
tions. Various risk stratification models for SSI hospital stay, preoperative
exist, such as the SENIC index predicted SSI risk antiseptic showering
and the NNIS basic risk index, but their actual Intraoperative Antimicrobial prophylaxis,
use in surgical practice has been limited. maintain normothermia, optimize
tissue oxygenation, use of
The majority of SSIs are secondary to endoge-
alcohol-based skin preparation,
nous flora occupying the surgical site. plastic wound protectors for
Staphylococcus aureus is still the most common biliary and GI surgery, use of
organism overall, followed by K. pneumoniae, surgical checklist, avoid blood
transfusions, asepsis, meticulous
E. coli, and Enterococcus [1]. Variations may
surgical technique, proper
exist depending on the type of surgery. instrument sterilization
Immunocompromised patients can have SSIs from Postoperative Proper incision care, appropriate
a variety of less common organisms, including discharge planning, patient
fungi. Treatment focuses around meticulous wound education
care and antimicrobial therapy. Some superficial
and deep SSIs can be successfully treated with rates outside the operating room has been refuted
suture removal, draining any collections, debriding [68] and needs to be coupled with decolonization
the fibrinous exudate, and frequent dressing strategies in order to be effective. We need to
changes. Deeper infections, especially those asso- standardize and bundle our efforts in a similar
ciated with cellulitis, will require oral or systemic fashion, as they are most effective when used in
antibiotics and a strategy to heal by secondary conjunction.
intention if the wound is opened. Negative pressure Best practice bundling through Comprehensive
dressings or daily wound care with moist saline Unit Safety Program (CUSP) has been an
gauze will aid in wound maintenance and acceler- extremely effective strategy in curbing various
ate healing. In some cases, flap coverage may be HAIs. The AHRQ plans to reinvigorate efforts for
necessary to close the infected site. Normothermia SSI reduction by implementing the Comprehensive
and euglycemia are equally important in mitigating Unit Safety Program in operating rooms called
risk of infection both pre- and postoperatively. Surgical Unit-Based Safety Program (SUSP). In
addition to prevention, proper surveillance is vital
to the efforts. Multiplicity of platforms such as the
Prevention ACS-NSQIP and NHSN collect and report SSI
data. Depending on the veracity of data, 16–84 %
In 1999, the CDC released comprehensive guide- of SSI’s will occur after discharge [69]. The ACS-
lines, focusing on pre-, during and postoperative NSQIP quality assessment improvement tool
phases of surgical wound care, for SSI reduction, attempts to follow complications, such as SSI, in
Table 27.3. Although strong evidence exists to the post-acute phase. Accurate data collection will
suggest effectiveness of these strategies, compli- be critical to improving quality of care provided
ance has been less than ideal [65, 66]. A parallel to surgical patients.
initiative by CMS, the Surgical Care Improvement
Project (SCIP), was implemented nearly a decade
ago. Despite increasing adherence, there has not
been a remarkable improvement in SSI rates Pneumonia
[67]. This brings into question our understanding
of effective strategies and surveillance programs Pneumonia can be defined as community acquired
in place. For example, a popular opinion that or nosocomial. Nosocomial or hospital-acquired
hand washing, by its own, can reduce MRSA SSI pneumonias (HAPs) can be further subdivided
into ventilator-associated pneumonias (VAPs). support and surgical intervention where necessary.
Definitions vary in literature, but in general, HAP Antibiotic therapy should be of adequate dosage,
occurs 48 h after admission and is not present at covering the causative agent, and be tailored or de-
admission [70]. VAP occurs 48–72 h after endotra- escalated once cultures and sensitivities are avail-
cheal intubation. Healthcare-associated pneumo- able to avoid multidrug resistance. Inadequate
nia (HCAP) is another entity, which includes therapy is associated with higher mortality in VAP
nonhospitalized patients with extensive healthcare [78]. Along with adequate antimicrobial therapy,
contact preceding the infection [70]. Pneumonia is complications of pneumonia (abscess, empyema
the most frequently encountered HAI [1]. or effusions) can require tube thoracostomy or
Mortality associated with HAP is estimated decortication for adequate treatment.
between 27 and 50 % [70]. Higher mortality rates
are considered attributable to VAP, though this
remains controversial [71]. The NHSN reports Prevention
VAP rates of 0.0–4.4 per 1000 ventilator days [72].
Incidence is among highest in surgical, burn, and Standard measures for preventing HAP include
trauma units. hand hygiene, aerosol and contact precautions,
Risk factors for HAP include extremes of age, and other infection control measures. More spe-
underlying respiratory condition (COPD, ARDS, cific interventions focus on avoiding or mini-
etc.), impaired consciousness, aspiration, and mizing endotracheal intubation. Noninvasive
mechanical ventilation [73]. Surgery [74] and positive pressure ventilation can be a suitable
trauma [75] are independent risk factors for alternative in select patients. If mechanical ven-
developing VAP. Mechanical ventilation is the tilation is necessary, risk can be minimized
most important risk factor; the risk of developing through sedation breaks, daily assessment for
pneumonia increases with each day of intubation extubation, early mobility, and use of secretion
[73, 76]. Almost every diagnostic criterion relies ports for subglottic drainage. Oropharyngeal
on a combination of clinical, radiological, and and digestive decontamination have shown to
microbiological evidence. Fever, leukocytosis, minimize VAP risk. Similarly, use of prophylac-
hypoxemia, or purulent sputum needs to be asso- tic antibiotics has shown promise in ventilated
ciated with a new infiltrate viewed on a chest patients. No concrete evidence for VAP reduc-
radiograph. The diagnostic accuracy increases tion exists for head-of-bed elevation and stress
when these signs are coupled with a positive ulcer prophylaxis, but these measures are read-
gram stain and positive sputum culture (sensitiv- ily employed in the ICU setting.
ity: 69 %, specificity: 75 %) [77]. The diagnostic In addition to employing these best prac-
approach for VAP is similar but may be strength- tices, any success in preventing HAP is hostage
ened with sampling of respiratory secretion with to the same principles that have been discussed
bronchoalveolar lavage. Bacteria are the most in other HAIs. These include bundling of pro-
commonly isolated pathogens. Viruses and fungi cesses (e.g., CUSP), monitoring, regular sur-
are more likely to be isolated from immunocom- veillance, compliance, and ultimately, internal
promised hosts (lung transplant, steroid use, neu- and external accountability. Multidisciplinary
tropenic patients). In a recent multipoint survey, teams led by quality champions are critical to
Staphylococcus aureus was the most common sustaining a dynamic safety culture. These not
bacterial organism, followed by Pseudomonas only include physicians and hospitals but also
aeruginosa and Klebsiella pneumoniae [1]. managers and administrators in nursing homes,
Traditional gram-negative bacilli account for the post-acute facilities, and rehabilitation centers.
majority of the infections. Finally, engaging and educating patients
Therapeutic algorithms for pneumonia depend regarding HAP and HCAP will further catalyze
on prompt but judicious antibiotic use, pulmonary decline in rates.
Clostridium difficile Infection may include fever, leukocytosis, dehydration asso-

ciated with progression to septic shock, and multi-
Nosocomial gastrointestinal infections are gar- system organ failure.
nering increased public health focus. Chiefly Diagnosis of CDI should be suspected in
among these is Clostridium difficile infection patients with more than three episodes of diar-
(CDI) which contributes to as many as 70.9 % of rhea within 24 h or ileus in the setting of appro-
all gastrointestinal illnesses. Clostridium difficile- priate risk factors (recent antibiotic use, prolonged
associated diarrhea or CDAD is an emerging hospitalization). Confirmation of diagnosis
problem in healthcare due to improper antibiotic requires demonstration of the C. difficile organ-
use and the spread of hyper-virulent strains. ism or its toxin in the sample. Stool culture,
Incidence of CDAD has grown steadily since although being most sensitive, is rarely preferred
2000, plateauing only recently [79]. In 2011, over PCR. Radiographic imaging and endoscopy
453,000 cases were reported in the United States, are adjunctive to diagnosis. Treatment with anti-
out of which 65.8 % were healthcare associated microbials is not warranted for asymptomatic
[80]. A recent epidemiological report found C. carriers. Accordingly, the inciting antibiotic
difficile to be the most prevalent causative organ- should be discontinued. Symptomatic disease
ism for HAIs [1]. With the potential to cause will require oral or intravenous antibiotic therapy
severe disease, prolonged hospitalization, and or both depending on the severity of illness.
death [81], reduction in CDIs has been a top pri- Recurrent disease can be treated with combina-
ority for state and federal healthcare regulatory tion therapy which includes vancomycin, fidax-
and oversight bodies. omicin, and fecal transplantation [86]. Surgical
Clostridium difficile is a spore-forming, gram- treatment involving total abdominal colectomy
positive, strict anaerobic bacillus that is part of with end ileostomy is reserved for progressive
the normal intestinal flora. Spores are spread rou- disease not responding to medical therapy.
tinely through the fecal-oral route. Both patients
and healthcare personnel are frequently colo-
nized, acting as reservoirs for transmission [82]. Prevention
Colonization is not synonymous with infection;
hospitalized patients who are colonized are Clostridium difficile infection in US surgical
offered some immunity from developing CDAD patients, especially those undergoing intestinal
[83, 84]. Bacterial overgrowth and toxin produc- resections, is a major problem [88]. CDIs are an
tion by colonized strains will lead to diarrhea and independent predictor for increased hospital length
any subsequent systemic consequences. of stay, cost, and mortality in surgical patients [88].
Risk factors for infection include extremes of Reporting of CDI events is mandatory as part of
age (tenfold higher in age >65) [85], prolonged CMS vision to improve quality in healthcare since
hospitalization, and antibiotic use. Secondary risk 2013. This initiative is reinforced by active surveil-
factors include comorbidities (obesity, diabetes), lance programs (NHSN and Emerging Infection
factors that affect gastrointestinal integrity (inflam- Program) managed by the CDC to monitor our
matory bowel disease, gastric acid suppression, progress in prevention. The National Action Plan
enteral feeding), or cause immunosuppression for prevention of HAIs has targeted a 30 % reduc-
(HIV, malnutrition, stem cell transplantation, che- tion in healthcare-associated CDIs by 2015.
motherapy) [86]. Clinical manifestations of CDIs Reducing CDI rates require strategies that pre-
vary widely. Most patients are asymptomatic carri- vent horizontal transmission, minimize exposure,
ers. Others may develop CDAD, colitis (with or and decrease risk factors for those exposed, as
without the presence of pseudomembrane), or ful- detailed by the Society for Healthcare
minant disease [87]. Mild disease will usually pres- Epidemiology of America (SHEA) (http://www.
ent with abdominal pain and cramping, frequent cdc.gov/HAI/pdfs/cdiff/Cohen-IDSA-SHEA-
passage of unformed stool. More severe CDAD CDI-guidelines-2010.pdf). Appropriate hand
hygiene, contact precautions, early detection and With over 60 % of operations taking place in
isolation of patients, dedicated equipment, and ambulatory surgery centers, quality measures
environmental disinfection will minimize trans- need to be extended outside the traditional hospi-
mission and exposure [89, 90]. Antibiotic steward- tal setting. Similarly, invasive and critical medi-
ship is essential. Stricter hospital policies regarding cal therapies are now routinely being administered
the type and duration of antibiotic use can mitigate in nursing homes, dialysis centers, etc. There is
risk in exposed individuals [90]. Restricting use of growing concern that attention to infection con-
clindamycin and fluoroquinolones is directly trol maybe lacking [91, 92] in centers outside of
related to fewer outbreaks of C. difficile. Analogous the hospital. Aggressive infection control in out-
themes such as multidisciplinary involvement at side centers needs to be addressed.
hospital level, staff and patient education, and Further research and innovation in the field
internal reporting including measuring compli- will help us understand the problem, minimize
ance are synergistic to preventive efforts. Statewide variability in our approach, and accurately mea-
collaborates from Illinois, Massachusetts, and sure our successes.
New York report 15–25 % reduction in CDI rates
by implementing aforementioned approaches.
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Safer Medication Administration
Through Design and Ergonomics 28
Sheldon S. Sones and Paul Barach
“Do the right thing. It will gratify some people and astonish the rest.”
—Mark Twain
regulatory setting are now being applied in the

Part I: Introduction broader context of quality improvement in health-
care delivery systems [9]. As might be expected,
Since the early 1990s, adverse drug events have the expanding role of these terms has been coupled
received significant attention from researchers in with their use in contradictory ways, even within
quality and patient safety [1]. Nationally recog- the same discipline [4, 7, 10–14]. In this chapter,
nized quality experts have identified adverse drug we use a case of an actual patient as a framework
events as a top safety priority [2] because these to explain the recognition, treatment, documenta-
events are the most common type of iatrogenic tion, and reporting of drug-related harm.
injury [3]. Studies have indicated that adverse In the rapidly evolving shift from hospital-based
drug events occur almost daily in medium-sized surgery to ambulatory surgery centers (ASC), the
hospitals and outpatient, ambulatory clinics [4–6]. management of medications in both a safe and effi-
However, despite the high morbidity and mortal- cient manner is a key focus of overseers from fed-
ity, physicians often do not recognize or appropri- eral, state, and accrediting organizations. It
ately treat instances of drug-related harm [7, 8]. continues to be, year after year, an enunciated
We believe that inadequate recognition and national patient safety goal of the Joint Commission.
treatment of drug-related harm are, in part, a result Clearly, an effective program is a complex chal-
of what has been called a Tower of Babel of termi- lenge that calls for proactive efforts on the part of
nology [1]. Terms originally developed in the nar- the facility’s staff, leadership, and, importantly,
row context of drug effects in a clinical and support from the medical staff. Additionally, the
role of the pharmacist and medication management
S.S. Sones, BS Pharm, RPh, FASCP (*) oversight programs in these facilities are key fac-
Safe Medication Management & Pharmacy tors in the overall success of achieving these goals.
Consulting Services, 18 Deming Farm Drive, In this chapter, we review some basic elements of
Newington, CT 06111, USA
e-mail: [email protected] performance (EOP) for medication management
safety and regulatory compliance.
P. Barach, BSc, MD, MPH
Foundation and Kyle John Rymiszewski Research
Scholar, Children’s Hospital of Michigan, Patient Story
Woodward Avenue, Suite 13001, Detroit,
MI 48202, USA A 15-year-old boy underwent elective right knee
e-mail: [email protected] arthroscopy and debridement under general anes-

462 S.S. Sones and P. Barach
thesia with a laryngeal mask airway (LMA). Table 28.1 When to suspect wrong drug administration
in the operating room
He was otherwise healthy with no allergies to
medications. After uneventful induction of anes- (a) Unusual response or lack of response to drug
administration: pounding heart, mental status
thesia, the surgeons requested antibiotic prophy-
changes, apnea, muscle weakness and visual
laxis with cefazolin 1 g, which the anesthesiology disturbances
team administered. Just before the surgical inci- (b) Extreme or unexpected increase or decrease in
sion was made, 50 mcg of fentanyl was adminis- blood pressure or heart rate
tered. About 2 min later, spontaneous respirations (c) Unexpected or persistent muscle relaxation
slowed, and the patient became apneic. The sur- (d) Unexpected change, or lack of change, in level of
geon and anesthesiologist assumed the patient’s consciousness
(e) Incorrect ampule found to be open in work area
apnea was due to opiate sensitivity and assisted
ventilation by hand for 30 min. However, despite
a rise in the end-tidal CO2 to 70 mmHg, sponta-
Table 28.2 Checklist: steps to determine drug
neous respirations did not return.
administered
(a) Check the syringes and ampules used during the
case
Case Commentary (b) Check to see if low volume unexpectedly remains
in syringe
hen to Suspect Wrong Drug
W (c) Inspect open ampules
Administration in the Operating (d) Impound the “sharps” container to allow
Room inspection of ampules and syringes at later time
(e) Consider drawing blood levels to ascertain drug
given
The patient experienced an adverse event while
under anesthesia care. Apnea during anesthesia
has several etiologies, including anesthetic agents
themselves, as well as opiates, barbiturates, or Clinical Management of Apnea
benzodiazepines, and hypocarbia-induced respira-
tory depression. Prolonged apnea occurs more The most common drugs that may lead to apnea
often in hyperventilated patients; neonates; elderly in the operating room include muscle relaxants or
patients; patients with compromised renal, pulmo- highly potent opiates (such as sufentanil, which
nary, or hepatic function; hypothermic and aci- is ten times as potent as fentanyl). Alternatively,
dotic patients; patients receiving neuromuscular the patient may have a previously unrecognized
blockade, aminoglycosides, or intravenous mag- metabolic disorder such as a neuromuscular dis-
nesium; and patients with neurological impair- ease (i.e., myasthenia gravis) or a structural
ment or injury. Assuming this patient is healthy, abnormality (i.e., stroke or embolism) that needs
normothermic, and not acidotic or hypocarbic and to be evaluated. Treatment of medication-induced
assuming he did not receive neuroaxial anesthetic respiratory depression adverse event varies by
blockade (such as spinal or epidural regional anes- cause (see Table 28.3). When respiration is
thesia), clinicians should be concerned that the depressed by opiates, as evidenced by miotic,
patient received an unplanned drug due to a unresponsive pupils, naloxone (Narcan) in
syringe or an ampule “swap” (see Table 28.1). 0.04 mg increments may be titrated to reverse the
While maintaining cardiovascular and respira- condition. In the case of persistent peripheral
tory functions, clinicians should attempt to ascer- muscle blockade, typically due to residual mus-
tain whether a wrong drug was administered and, cle relaxants, reversal with neostigmine is initi-
if so, which drug (see Table 28.2). ated. Other interventions include discontinuation
28 Safer Medication Administration Through Design and Ergonomics 463
Table 28.3 Clinical management of apnea There are few accurate measures of the
(a) Ensure adequate oxygenation and ventilation morbidity and mortality associated with anes-
(b) If the error in drug administration is recognized thesia [15]. It has been estimated that between
immediately after injection: 2000 and 10,000 patients die each year from
a. Stop the IV carrying the drug
b. Attempt to aspirate or drain the IV tubing to
causes at least partially related to anesthesia, but
point of injection those estimates are based on circumstantial data
c. If there is blood pressure cuff on the arm of and include all patients regardless of age or
IV, inflate to slow down entry of drug to physical status [16]. A recent study in the United
central circulation
Kingdom found that only one patient in 185,000
(c) Maintain normocarbia or slight hypercarbia
died solely as result of anesthesia, although 1 in
(d) Increase O2 flow to breathing circuit to enhance
elimination of inhalation anesthetics 1351 deaths was in part related to anesthesia
(e) Check neuromuscular function with nerve [17]. An estimated 44,000–98,000 Americans
stimulator die in hospitals each year as a result of prevent-
(f) If residual blockade is present: able medical errors [18]. Bates and colleagues
a. Give reversal medication to max of have shown that medication errors were the
neostigmine dose of 70 mcg/kg along with
glycopyrrolate up to 1 mg to reverse blockade
number one cause of adverse and preventable
b. Reassure the patient and continue short-acting patient events that 6.5 % of admitted patients
sedation suffered an adverse drug event, and they lead to
c. Consider potential synergistic effects of more than 7000 deaths annually [19]. Of these
muscle relaxants and aminoglycosides—if so
give 1 g calcium chloride to promote reversal
events, 28 % were due to errors, and an addi-
of neuromuscular blockade tional 5.5 % involved near misses caught due to
(g) Review the doses of medication administered and interception of the error. In the Harvard Medical
check for syringe or ampule swap of opiates, Practice Study, adverse drug events accounted
hypnotics, muscle relaxants, anticholinergics for 19.4 % of all disabling adverse events, 45 %
(h) Consider reversal of specific drugs such as opiates of those events were caused by errors [20]. In a
(check the pupils), benzodiazepines,
anticholinergics large insurer’s study, injuries due to drugs were
(i) Send blood samples for ABG and serum the most frequent cause of procedure-related
electrolyte levels malpractice claims [21]. The prevalence of med-
(j) Conduct a neurological examination to exclude ication errors in the operating room is not accu-
focal CNS injury as cause of failure to breathe rately known. A recent study demonstrated that
about half of all surgeries involve some kind of
medication error or unintended drug side effects,
of anesthetics, determination of arterial blood a rate calculated by researchers who observed
gases, and appropriate adjustment of ventilation. 277 procedures and found that 1 in 20 periopera-
Because the apneic episode lasted longer than tive medication administrations included a drug
30 min, the anesthesia team began to question error and/or an adverse drug event [22].
their initial assumption that the apnea was due to Perioperative areas are among the only remain-
opiate sensitivity. They had obtained the cefazo- ing patient care areas that have not had rigorous
lin from the medication drawer of the anesthesia assessments of medical errors to guide proposed
cart. The anesthesia team examined the drawer solutions. Reductions in MEs in other patient
and found vials of cefazolin and vecuronium (a care areas, including inpatient units and outpa-
long-acting paralytic agent) in adjacent medica- tient clinics, have occurred because error rates
tion slots. The vials were of the same size and were measured, errors were categorized to deter-
shape, with similar red plastic caps (see Fig. 28.1). mine their root causes and potential for harm,
The team realized that the patient had received solutions were designed and implemented, and
vecuronium 10 mg, not cefazolin 1 g, and that the error rates were then systematically measured
observed apnea was therefore due to unrecog- again to show a reduction. This process has
nized muscle relaxation. occurred with solutions such as computerized
Fig. 28.1 Look-alike drug vials
physician order entry systems, bar-code scan- Medication Errors in Operating Room
ning systems for medication administration in
hospital pharmacies, and outpatient electronic Documenting errors at the administration stage is
prescribing systems [4, 23–25]. difficult, because it requires direct observations
Wrong medication administration in the oper- and reliable, robust near-miss and adverse-event
ating room is due to failure to label syringes, reporting systems. Currie and colleagues found
incorrect matching of labels on syringes and 144 incidents related to drugs, of which 58 were
drug ampules, failure to read the label on the related to syringe or drug swaps [28], among the
vial/ampule, misuse of decimal points and first 2000 incidents of the Australian Incident
zeroes, and inappropriate abbreviations. What Monitoring System. Of those 58 events, 71 %
happened to this patient illustrates an example of involved muscle relaxants. Implementing a red
faulty drug identity checking, where two drugs syringe color change for all succinylcholine drug
were packaged in similar vials, so that one was administration in Australia has helped to reduce
easily mistaken for the other. Poor system design drug and syringe swap by 70 % [29]. A large, ret-
also makes errors difficult to intercept before rospective study of anesthesiologists’ self-
injury occurs. Leape and colleagues discovered reported incidents found that of a total of 1089
that failures at the system level were the real cul- incidents, 71 were related to either syringe or drug
prits in more than three-fourths of adverse drug ampule swap (7 %) [30]. Leape and colleagues
events [26]. Reason and colleagues suggested found that 40 of 334 errors (12 %) at the stage of
that some complex healthcare systems are more drug ordering and delivery were due to imperfect
vulnerable and therefore more likely to experi- dose and identify checking [26]. Studies in inten-
ence adverse events [27]. sive care units have produced similar results [31].
Administrative medication errors in the between potent drugs used in operating rooms.
operating room and intensive care unit are For years muscle relaxants such as pancuronium
believed to be more common in unfamiliar set- vials were very similar to those of heparin. Some
tings, when drug packaging or ampules have manufacturers continue to package ephedrine in
changed, when similarly appearing ampules are ampules similar to those of oxytocin and epineph-
stored close together in the medication carts, rine. This problem also occurs with different doses
when syringes are prepared by other personnel, of the same drug—the vials for at least three con-
when handwritten labels are used, and when centrations of atropine sulfate from one manufac-
lighting conditions are poor [32]. There is an turer are similar. This results in inadvertent
exponential relationship between the number of over- and underdosing.
drugs administered to a patient and the preva- Any medication drawn into a syringe for later
lence of adverse drug events [33]. use should be labeled immediately. Unlabeled and
incorrectly labeled syringes invite errors in drug
administration and dosing and should be discarded.
ystem Theory and System Checks
S Routine use of approved, commercial color-coded
to Prevent Wrong Drug labels may reduce these errors. The labels should
Administration conform to the standards of the American Society
for Testing and Materials (ASTM) [36].
Although there is no excuse for failing to read A cluttered and disorganized workspace also
medication and syringe labels, the occasional fail- predisposes to medication errors and searches
ure to do so represents an expected “slip,” more that can delay administration of emergency medi-
likely to occur with fatigue, distraction, or other cations. All anesthesia and resuscitation medica-
causes of momentary lapses in concentration and tion carts should be standardized (see Fig. 28.2),
failures in automatic behaviors [34, 35]. Not until by applying a systematic method for stocking
recently did the pharmaceutical industry realize new and discarding outdated medications.
the importance of packaging medications to easily To understand the causes of errors, we must
facilitate rapid identification of and discrimination examine what happened, what was the root cause,
Fig. 28.2 A well-organized anesthesia cart that keeps similar-looking and/or similar-sounding drugs well separated
Table 28.4 System checks to prevent wrong drug tions utilized in the facility are FDA approved, are
administration
appropriate for the size and scope of the facility,
(a) Check for correct patient, drug name, and will be safely managed using required equip-
concentration, dose, route, time
ment where necessary (such as calibrated pumps)
(b) Use drug labels that conform to ASTM standards
and that the nursing staff has a pathway to assure
(c) Label syringes carefully—use preprinted
color-coded adhesive labels safe handling of these medications.
(d) For emergency drugs, use “ready-to-use” syringes Specifically, in addition, the committee
that are prepared according to ASTM standards should endorse the contents of the emergency
(e) Standardize location of medications “code cart” as well as, where applicable, the
(f) Discard unlabeled vials, syringes drugs required for reversal such as the malignant
hyperthermia requirements and reversal agents
availability, such as naloxone and flumazenil. It
and what were the underlying system failures. In is in the purview of this committee to assure that
a system analysis, people are viewed as an impor- the list is reviewed annually, as is the entire for-
tant safety resource, not only a source of errors. mulary, to assure continuing appropriateness
Designing robust transparent systems, with built with an eye toward contemporary and published
in feedback control strategies, is important given guidelines and standards. Not only identified
human flexibility and fallibility. This was a case drugs, but the quantities of the agents in the
of unintentional administration of a paralytic “code cart” should be memorialized in the min-
agent in place of an antibiotic due to similar utes of the meetings.
packaging. System checks that could be imple-
mented here to avoid inadvertent drug swaps
include color-coded labeling and reorganization Controlled Drug Management
of the anesthesia cart (see Table 28.4).
Training all healthcare professions in the six Perhaps the most focused area to review is the sta-
rights—patient, drug, dose, route, time, and con- tus of controlled drug management in the hospital
centration—is critical to effective and safe medi- or ASC. The management of controlled drugs rep-
cation administration. Recognizing environmental resents significant challenges. The system has to
factors that predispose and distract clinicians is afford easy access for both the nursing and anes-
paramount. These include noise, interruptions, thesia staff, be in compliance with state and fed-
fatigue and lack of adequate rest, poor lighting, eral laws and regulations, as well as being managed
and poor information systems. in such a way as to limit unauthorized access.
There are several interested parties who may
present themselves with inquiry into the manage-
art II: Organizational Medication
P ment of controlled drugs. The external parties might
Safety Management include the Department of Health, Board of
and Procurement Medicine, Centers for Medicare and Medicaid
Services (CMS), accrediting bodies such as The
Formulary Management Joint Commission or DNV GL (Det Norske Veritas),
the federal Drug Enforcement Administration
While the hospital setting historically has a formal (DEA), the Accreditation Association for
pharmacy and therapeutic committee that over- Ambulatory Health Care (AAAHC) which oversees
sees the approved drugs endorsed by the medical a majority of ASCs, as well as sections of the state
staff, such structure usually does not exist in the government, which may have responsibilities on the
ambulatory surgery centers (ASC). This function state level for medication compliance.
is traditionally incorporated into the responsibili- Controlled drug records should reveal, in detail,
ties of the “Medical Executive Committee” or basic documentation of drug, dose, and time adminis-
similarly named committee. The charge to this tered, who administered, and, importantly, attestation
committee should be to assure that the medica- of drug discard of partial doses. It is this latter require-
ment that is most vulnerable to review and, if not done istration could cause serious adverse outcomes
properly, subject to inquiry as to the authenticity of the including central nervous system side effects,
discarding providers’ procedures. Controlled drug speech and visual disturbances, mental depression
discards should be done in real time and not at the end and confusion, respiratory depression, and sedation
of the workday. Drugs should be rendered “non- [37]. While in the case of MH preparedness, an
recoverable,” which by definition, and may vary from annual presentation is expected/required; the facil-
state to state. Facilities could avail themselves of ity must also train new employees who have joined
commercial products for such purpose, or, if allow- the facility after such a presentation.
able by individual states, discard to absorbable prod- When new drugs enter into the formulary, the
ucts and then to traditional waste systems. physician who has asked for inclusion as well as
One of the challenges in controlled drug man- the consultant pharmacist should be prepared to
agement is to meet the needs of the anesthesia pro- present to the staff the guidelines on the manage-
viders and, at the same time, assure that they are in ment of the new entity as well as their untoward
step with the facility’s overall responsibility of effects. This is an important part of the formulary
documentation and safe medication management. management system, to assure that not only safe
Regarding the latter, it is imperative that single- and effective drugs are accepted into the formu-
dose products be preferentially utilized as indicated lary, but importantly, they are safely managed.
and not for multiple patients. This extends to other Safe medication management education can be
products, which at this writing are not “controlled” provided through appropriate textbooks, videos,
except in a few states, such as propofol, but are and access to the Internet.
clearly designated as single patient use only.
The recording of retention of control drugs
may vary from state to state, but it is recom- Drug Procurement
mended that a three-year retention be a minimal
standard practice in hospitals and ASC. The selection of a vendor for supply of medica-
Finally, as facilities move toward computer- tions is important part of the medication system
ized medical records, as well as automated drug that must be relied on for a seamless continuum of
dispensing systems, the maintenance of control medication supply. Drug shortages and recalls
drug records will be less of a challenge. We will over recent years have complicated the challenge
address automatic drug dispensing systems in to assure adequate resources on a day-to-day basis
another section of this chapter. for the facility, for key drugs such as propofol.
Traditionally, facilities have aligned with a
single vendor, which is either selected by the
afe Medication Management
S facility or orchestrated by the purchasing section
Education of larger multi-facility companies. In either case,
we have seen drug wholesalers fall short in meet-
One of the contemporary expectations of the phar- ing the demands of their clients. This points,
macist as well as the medical staff leadership is to therefore, to the need to have several wholesalers
assure that the nursing, surgical, and anesthesia engaged as suppliers to the facility.
staffs have access to drug information as well as Wholesale providers should have the ability
presentations that are stipulated in accreditation to assume responsibility for prompt notification
standards. In fact, one such stipulation is in the area of drug recalls as enunciated either on the FDA
of malignant hyperthermia preparedness. It is website and/or directly from the manufacturer.
imperative that the staff be well acquainted with the The economics of medication supply, as well
management of this sudden and life-threatening as all supplies, cannot be overstated in this pres-
challenge. Further complicating this initiative is ent climate. Prudent purchasing practices require
that the dantrolene sodium used for reversal tends “benchmarking” cost experience for high-vol-
to be difficult to manage under a time-dependent ume and/or high-cost drugs. This is enabled
scenario that could have negative outcomes if drug when the consulting pharmacist has established
management falls short. Likewise, incorrect admin- a system that draws information from the facili-
ties they serve. Drug costs which fall outside of has prompted states and regulators on a federal
the normal experience are highlighted on this level to focus on monitoring and regulating com-
form for the facility to review with their pro- pounding pharmacies to a degree heretofore
vider. Finally, it is suggested that the wholesaler unprecedented.2 In selecting a compounding
establishes a representative who can communi- pharmacy as a provider, the facility must be
cate routinely and effectively with the facility to explicit in drawing attestations from proposed
resolve issues as well as opportunities for effec- providers to best assure insulation from poor or
tive/cost-containing initiatives. mediocre practice. The consultant pharmacist
should be relied on to help navigate this very
important decision and help orchestrate the deci-
Injection Practices sions based on a number of elements.
While it would be ideal for on-site visits of the
The literature is replete with guidelines and posi- compounding pharmacy to be conducted by the
tion statements on safe injection practices (http:// facility and its leadership, this is not always fea-
www.cdc.gov/injectionsafety/). The Association sible nor can all visitations be conducted by indi-
for Professionals in Infection Control and viduals with the knowledge base of this complex
Epidemiology (APIC) has led the way in provid- specialty. Accordingly, it would be prudent to
ing educational outreach, materials, and stan- employ some tools such as the “contractor assess-
dards, which also reflect positions defined by the ment tool” produced by the American Society of
Centers for Disease Control. These are presented Health-System Pharmacists (ASHP) Research
as an addendum to this chapter. and Education Foundation. Another resource is
It is always a challenge to move practitioners away generated by the International Academy of
from habits of the past, which in their minds have Compounding Pharmacists (IACP) with their
been successful. However, contemporary healthcare “Compounding Pharmacy Assessment
providers should acknowledge the clear evidence that Questionnaire” (CPAQ®).
safe injection practices are a mandatory element of Both of these instruments afford the phar-
performance that can significantly improve outcomes macy the ability to issue a signed “attestation”
and minimize untoward effects. Additionally, the regarding their commitments to established stan-
proper labeling of drawn syringes, handling of multi- dards. This is an important part of the due dili-
ple-dose vials, restriction of single-dose vials for sin- gence process. While each state will have its own
gle use only, handling of IV solutions, and prudent guidelines and regulations regarding sterile com-
due diligence in selecting a compounding pharmacy pounding pharmacies, most facilities engage a
for the facility are all mandatory steps, which the Food and Drug Administration (FDA)-registered
facility should not waiver from in assuring the entire 503B human drug outsourcing facility. These
spectrum of safe injection practice expectations. facilities are registered with the FDA, enlist their
awareness of potential FDA inspection, and
adhere to such standards. Facilities should also
Compounding Pharmacy Selection1 be vigilant on FDA recalls related to compound-
ing pharmacies.3
Tragic events over the past several years in places
such as in Massachusetts and elsewhere reflect
deficits in compounding pharmacy practices,
which provided subpar or, even worse, inatten-
tion to current Good Manufacturing Practices
2
http://theincidentaleconomist.com/wordpress/new-
(cGMP). This newly uncovered gap in oversight
massachusetts-law-on-compounding-pharmacies/
3
http://www.fda.gov/Drugs/GuidanceCompliance
1
Adapted from APIC Position Paper: Safe Injection, RegulatoryInformation/PharmacyCompounding/
Infusion, and Medication Vial Practices in Heathcare. ucm339771.htm
Drug Recalls formance review and, more importantly, should

be readily accessible to the facility’s own staff
It is imperative that when drugs are recalled by including medication reconciliation documents,
the manufacturer or FDA that it be promptly physician order sets both preoperatively and post
sequestered by the facility to eliminate the pos- procedure, medication documentation forms,
sibility of administration to patients. It is an discharge instructions, and the anesthesia record.
implicit expectation that suppliers promptly The anesthesia record should be explicit as to
notify facilities when they have determined that which drugs were administered, when they were
the facility has received lot numbers of recalled administered, and in what dosage. It continues to
items. While this obviously applies to all prod- be a routine challenge when the anesthesia record
ucts, certainly, the recall takes on a higher level is maintained manually and how to decipher the
of importance when it pertains to contaminated, required elements given illegible handwritten
sub- or superpotency, or other manufacturing records.
deviations. The facility should have a recall sys- Of particular interest is the ongoing assessment
tem that affords easy access, such as facsimile or of antibiotic administration times in relation to the
other electronic means, to assure recall alertness. start of the procedure/incision. Reference is rou-
Proper documentation of action taken by the tinely made to the standard of the start of adminis-
facility is a reasonable expectation of overseers. tration of the antibiotic within 60 min of surgical
incision or procedure start [38]. Correct adminis-
tration of antibiotics has drawn the attention of
Drug Defect Reporting both the American Society for Gastrointestinal
Endoscopy (ASGE) and the Society of
An ethical and regulatory obligation to our Gastroenterology Nurses and Associates (SGNA).
patients is a prompt communication to regula- In 2007, the Centers for Medicare and Medicaid
tory depots regarding suspected drug defects. Services (CMS) listed antibiotics administered for
The mechanism in place is to complete the prophylactic purposes prior to surgery/procedure
“MedWatch” forms and submit them for further as part of its quality reporting program. For 2013,
investigation where warranted. MedWatch is it became a “G-Code” entry. The measure indi-
the FDA’s Safety Information and Adverse cated was “within 1 h prior to surgery” [39]. The
Event Program.4 Medical Letter [2] called for “60 min or less prior
to incision.”
Clarity of the Medical Record

Role of the Pharmacy Consultant
While electronic medical records may well miti-
gate current concerns regarding the clarity of the Each facility should secure the services of quali-
patient record/medical record, currently, most fied pharmacy consultant. Hospitals have a con-
facilities still maintain what we would refer to as tinuum of service from their own pharmacy
a “manual record.” Regardless of the status of department; surgical centers have to draw on out-
the facility’s movement toward the electronic side consultants to oversee pharmacy systems in
medical record (EMR), it is imperative that all general and medication management in specific.
stakeholders have access to the detail contained Each state has either very specific requirements
in this document. That would include physician, or duties enlisted in regulation or are vague or
nursing, and financial information that is perti- mute regarding this role. It is interesting to note
nent to the care and administrative management that accrediting agencies allow for a qualified
for the patient. Within the medical record, there physician to oversee the services. However, this
are several elements of probable regulatory per- often tends to fall short and does little to provide
substantial input and guidance to medication
4
http://www.fda.gov/Safety/MedWatch/ safety and will most likely not provide the proper
guidance to avoid medication misadventures and/ medical staff and has the pharmacist as a member
or regulatory criticism. in addition to nursing leadership. As noted earlier
The duties of the consultant pharmacist should in this chapter, most ambulatory surgical facilities
include a physical inspection of the facility on the move this committee’s function to the Medical
frequency based on the scope and size of the Executive Committee (MEC).
facility, educational outreach, easy accessibility The infection control committee is a committee
to respond to questions as they arise, controlled that considers strategies to minimize exposure of
drug system development and monitoring, and patients, and/or staff, to infection-prone practices
clinical review of the medical record and should or other professional missteps. In addition to the
be followed by signed dated reports. These medical and nursing staff of the facility, the infec-
reports should be problem-oriented with suggestion control prevention asked, as well as the phar-
tions for improvement and should be validated as macist, who are key members of this committee.
resolved on the consultant’s next scheduled visit. The third committee is the quality assurance
A signed contract, which delineates the responsi- committee. The broad mission of this committee
bilities of the consultant as well as that of the is to assure that proper mechanisms are in place
facility, is provided as an example, at the end of to assess and respond to quality assurance com-
this chapter (see Appendix 1). pliance. The committee should also evaluate
untoward events when they relate to medication
management, infection prevention, or other expo-
harmacy and Medication Safety
P sures to unwanted and unexpected occurrences.
Committees
Three important committees, which oversee Emergency Preparedness

medication management or make decisions that
affect medication management in the facility, are The facility, depending on the scope and mission of
usually part of the administrative oversight and the facility, and its area of specialty must assure all
ambulatory surgical center. of the stakeholders that they are adequately pre-
The pharmacy and therapeutics committee pared for unanticipated natural or human-made
(P&T), or a similarly named group, is responsible disasters and events [40]. Implicit in this prepared-
for the policies and procedures that are staged to ness is adequate educational training for the staff
assure safe medication management. In addition to that is ongoing and part of the new employee orien-
policies and procedures, this committee is respon- tation. All employees should be aware of the tools
sible for the organization and management and and resources that are available within the facility
ongoing focus of the facility formulary. This docu- to respond appropriately to a medical event, nega-
ment is a formal endorsement of various drugs tive outcomes from administered drugs, or a com-
used in the facility and considers drugs for addi- bination of both [41]. The expectations are that the
tion or deletion as appropriate. Physicians who facility has adequate resuscitation and cardio con-
want to support the addition or deletion of a drug version equipment, and as mentioned above, there
should present the facility with detailed informa- is a high level of workable knowledge among the
tion, through this committee, regarding its use, staff to employ these resources [42, 43].
contraindications, financial impact, and distinctive The “code cart” and its appropriate contents of
features of the proposed drug that warrants consid- both drugs and equipment is a basic requirement in
eration for adoption. Conversely, when drugs fall all facilities. Regarding the drugs, the contents
out of use in the practice setting, due to replace- should be listed based on the size and scope of the
ment with a newer agent, or concerns about its facility and include as a minimum, all medications
continued appropriateness or safety, proposals for required in ACLS protocols. Routinely, code cart
removal of the drug from the formulary are simi- contents are staged beyond the ACLS group of
larly considered by this committee. The commit- drugs and will include drugs for ATLS and PALS
tee is usually made of the executive group of the protocols. Reversal agents, appropriate intravenous
fluids, antihistamines, corticosteroids, as well as Practices (ISMP) of Horsham, PA, and include
the full battery of cardiac drugs are rather standard newsletters, alerts, research, and educational and
contents. Of major concern, as previously men- consulting services. Valuable guidelines and
tioned, is the facility level of capability to treat charts such as drugs with confusing names, high-
malignant hyperthermia (MH). For codes in gen- alert drugs, as well as numerous other resources
eral, as well as MH-specific protocol, the facility are provided through their exceptional staff.
should conduct routine mock drills usually directed
by an anesthesiologist in conjunction with the
pharmacy consultant. The contents of the cart Conclusions
should be reviewed regularly by the medical staff
committee. This committee needs to assure that the Erroneous medication orders continue to maim
contents reflect contemporary practice standards and harm thousands of Americans annually and
and that appropriate educational processes are in millions of people around the world. Medication
place on an ongoing basis. management is a high priority of all of the stake-
holders and those who oversee the facility with
regulatory responsibilities. Medication manage-
Additional Resources ment touches every physician, every nurse, and
every patient, and all of these participants who
There are several resources which facilities are share the mission of safe effective outcomes must
encouraged to pursue to provide a continuum of remain vigilant on both preparedness, as well as
information and strategic steps to maximize the on the part of the patients, assuring reasonable
effectiveness and safety of the medication man- compliance.
agement program in hospitals and ambulatory Adverse drug reactions are injuries caused by
surgical centers. drugs administered at usual doses; they are the pri-
One of the valuable services that pharmacists mary focus of regulatory agencies and post-
can provide is to enable the facility to compare, or marketing surveillance. Medication errors are the
benchmark, their performance to other similar number one cause of preventable adverse events,
facilities. Quality measures or metrics, when prop- including death. Causes of wrong drug administra-
erly applied, can afford the facility insight into tion include failure to label medications, mislabel-
opportunities for improvement or, conversely, ing of syringe or ampules, or failure to confirm
validate excellent trending. Since most consulting identification of the medication by reading label
pharmacists serve a variety of facilities and within carefully. To reduce drug administration errors in
those clients, a variety of specialties, they are well the OR, label syringes carefully with color-coded,
positioned to gather and bring forth comparative preprinted labels that conform to ASTM stan-
performance measures. We call this a “VBP” or dards; use “ready-to-use” easily identified syringes
value-based program. Benchmarking has been to administer emergency drugs; standardize loca-
done for ophthalmology (i.e., vitrectomies), gas- tion of medications on the anesthesia cart; and
troenterology (i.e., perforation and adenoma always review the six rights (patient, drug, dose,
detection rates), antibiotic administration (i.e., route, time, concentration). System checks should
conformance with the 1 h guideline), orthopedics, be designed into the medication administration
patient satisfaction, hospital transfers, slips and process to prevent or reduce chances of inadver-
falls, and importantly the pharmacoeconomics of tent drug/vial swap. While putting pharmacists in
surgical care. Regarding the latter, there are bench- hospitals, in all patient care areas, and ensuring
marks for high-cost and/or high-volume drugs and there is pharmacy expertise, overseeing all medi-
have been immensely successful in significantly cation administration is central to delivering reli-
decreasing costs once the facility is aware of the able and safe patient care [44]. In the ASC,
benchmark of specific drug acquisition. however, collaboration of the entire surgical team,
Details beyond the scope of this chapter are including the consulting pharmacist, is essential to
available by the Institute for Safe Medication delivering high-quality and safe care.
ppendix 1: Contract Pharmacy and Medication Management Consultation

A
Services
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Preventing Venous
Thromboembolism Across 29
the Surgical Care Continuum
Lisa M. Kodadek and Elliott R. Haut
“The disconnect between evidence and execution as it relates to DVT prevention amounts
to a public health crisis.”
—American Public Health Association
PCORI
Patient-Centered Outcomes Research
Abbreviations Institute
PE Pulmonary embolism
AAOS The American Academy of Orthopedic SC Subcutaneous
Surgeons SCDS Sequential compression devices
ACCP The American College of Chest TEDS Thromboembolic deterrent stockings
Physicians US United States
AHRQ The Agency for Healthcare Research V/Q Ventilation/perfusion scan
and Quality VTE Venous thromboembolism
APHA The American Public Health Association
CDS Clinical decision support
CPOE Computerized provider order entry
DVT Deep vein thrombosis
EAST The Eastern Association for the Surgery Background
of Trauma
INR International normalized ratio Prevention of venous thromboembolism (VTE)
IVC Inferior vena cava is a critical patient safety practice as well as an
LMWH Low molecular weight heparin important measure of healthcare quality. VTE
refers to deep vein thrombosis (DVT), pulmonary
embolism (PE), or the presence of both. As many
as 350,000–900,000 people each year in the
United States (US) will be harmed by VTE, and
over 100,000 people will die from VTE each year
[1]. National annual expenditures for treatment
L.M. Kodadek, MD
of VTE may be as high as $10 billion [2]. While
Department of Surgery, The Johns Hopkins Hospital, high-quality evidence-based guidelines for VTE
600 N. Wolfe Street, Tower 110, Baltimore, MD prevention are available and strongly encouraged
21287, USA for adoption, studies continue to show that hospi-
talized patients are not routinely provided with
E.R. Haut, MD, PhD, FACS (*) risk-appropriate VTE prophylaxis [3, 4]. One
Department of Surgery, The Johns Hopkins Hospital,
1800 Orleans Street, Sheikh Zayed Tower, Suite
study has demonstrated that only 42 % of patients
6107C, Baltimore, MD 21287, USA diagnosed with DVT during hospitalization had
e-mail: [email protected] received VTE prophylaxis [5]. Another showed

480 L.M. Kodadek and E.R. Haut
that <60 % of surgical patients worldwide As public reporting and pay-for-performance

received appropriate prophylaxis [4]. initiatives have developed as effective tools to
Numerous groups have recognized VTE as a improve the quality of healthcare, it is prudent to
public health and safety problem. The American recognize that even when patients are prescribed
Public Health Association (APHA) issued a and administered VTE prophylaxis according to
White Paper in 2003 stating, “The disconnect guidelines, VTE may still not be preventable in as
between evidence and execution as it relates to many as 50 % of cases [17]. VTE prevention is
DVT prevention amounts to a public health crisis” quite effective but cannot drive the event rate to
[6]. The US Surgeon General recognized VTE as zero without undue risk of bleeding [17–19].
“a major public health problem” and issued “A National bodies, including the Centers for
Call to Action to Prevent Deep Vein Thrombosis Medicare and Medicaid Services, impose finan-
and Pulmonary Embolism” in 2008 [1]. The cial penalties when hospitalized patients develop
Agency for Healthcare Research and Quality VTE, despite the fact that many of these VTE
(AHRQ) has identified VTE prophylaxis as “the events are truly not preventable with current best-
number one patient safety practice” to prevent in- practice prophylaxis [19]. Policy changes at the
hospital death [7–9]. Most recently, AHRQ has regional and national level should focus on a
placed “Strategies to increase appropriate prophy- more impactful approach. A true benchmark of
laxis for VTE” on the list of top 10 “Strongly patient safety and quality care should not focus
Encouraged Patient Safety Practices” [3, 10]. The on the incidence of VTE (outcome measure),
collective attention from these groups has raised without considering how frequently patients are
awareness that passive strategies to improve VTE prescribed and administered VTE prophylaxis
prophylaxis are not as likely to be impactful as according to best-practice guidelines (process
active strategies, especially since well-done evi- measure). Rather than measuring incidence of
dence-based guidelines for VTE prophylaxis are VTE alone, some experts argue for a pure process
widely disseminated and available [11]. measure approach or combined process and out-
Closer evaluation of the VTE example reveals come measure instead [12, 13, 20, 21].
that the outcome measure of interest (decreased
incidence of VTE) is best improved by critically
evaluating the system of care and improving the Definitions
component process measures involved in preven-
tion of VTE [12]. For example, risk-appropriate DVT is the partial or complete occlusion of the
VTE prophylaxis is a process including assessment venous system from formation of venous thrombi,
and prescription by a provider, administration by a typically in the lower extremities. A proximal
nurse, and acceptance by the patient. Active strate- DVT involves thrombosis at the popliteal vein or
gies, including a reminder to providers to assess above, while a distal DVT is confined to the deep
individual patient risk for VTE and prescribe pro- veins of the calf. The “superficial femoral vein”
phylaxis as part of a standard electronic order set, is part of the deep venous system, and any throm-
are more likely to improve outcomes than passive bus identified within this vein must be treated as
dissemination of guidelines [10, 13–15]. Similarly, a deep, true DVT. PE refers to occlusion of the
active attempts to understand nursing practices and pulmonary vasculature and is thought to result
beliefs can identify barriers to the administration of from embolism secondary to DVT. More recent
prescribed prophylaxis [16]. Finally, since many data suggest that primary thrombosis of the pul-
patients are not aware of VTE or its potential con- monary vasculature may be the cause of some PE
sequences, patients may not recognize the impor- events [22]. The severity of PE determines mor-
tance of accepting prescribed prophylactic tality risk and is typically stratified according to
medications [6]. A cohesive approach to decreas- hemodynamics and assessment of right ventricu-
ing the incidence of VTE must address all aspects lar cardiac function. Massive or high-risk PE is
of the system of care. associated with hypotension, signs of cardiogenic
29 Preventing Venous Thromboembolism Across the Surgical Care Continuum 481
shock, and/or cardiac arrest. Submassive or changes and in 5–10 % of cases skin ulcerations
intermediate-risk PE is associated with preserved and chronic wounds [29]. Chronic thromboem-
hemodynamics but evidence of right ventricular bolic pulmonary hypertension may occur in
dysfunction or myocardial necrosis. These imme- 2–4 % of patients after acute PE and can result in
diately life-threatening PE events mandate imme- dyspnea both at rest and with exertion [23]. Some
diate intervention to salvage life. of these patients will ultimately succumb to right
heart cardiac ventricular failure and/or sudden
cardiac death. One group has recognized the need
Incidence and Cost to provide rehabilitation services to patients after
PE to improve dyspnea and functional capacity
Each year in the USA, there may be as many as [30]. Risk of recurrent VTE is highest during the
350,000–900,000 cases of VTE [1]. More than first 6–12 months after the initial episode, but the
100,000 people will die from VTE, making VTE cumulative risk of recurrence at 10 years may be
the most common cause of death from cardiovas- as high as 30 % [31, 32].
cular disease after heart attack and stroke [23]. Anticoagulation remains the mainstay of
Over one third of patients with DVT will experi- treatment for VTE to prevent recurrence and
ence PE [24]. Autopsy studies have identified PE associated sequelae, but clinically relevant or
in 7–27 % of patients postmortem, and in most of major bleeding can occur with any anticoagulant,
these cases, there was no clinical suspicion of PE especially at the beginning of treatment.
before death [25]. A single DVT or PE event has Furthermore, VTE may recur even with appropri-
been estimated to cost an additional $7700– ate anticoagulation treatment. The RIETE
$10,800 or $9500–$16,600, respectively, for Registry, a prospective, ongoing, multicenter
treatment in the hospital setting during the initial international registry, documents consecutive
event [9, 26]. As many as 5–14 % of these patients patients with confirmed symptomatic acute VTE
with VTE will require readmission to the hospi- [33]. In this series of over 19,000 patients with
tal, the readmission cost may vary from $11,000 VTE, 2.4 % had major bleeding after anticoagu-
to $16,000 [26]. Post-thrombotic syndrome, the lation was started, and one of every three cases of
most common long-term complication affecting major bleeding proved fatal.
patients with DVT, has been estimated to cost at
least $200 million annually in the USA [27].
National annual expenditures for treatment of Risk Factors
VTE in total may be as high as $10 billion [2].
While the costs of VTE are high and in many Virchow described the basic etiology of venous
cases represent preventable expenditures, the true thromboembolism as vascular endothelial injury,
cost of VTE to patients and society is consider- venous stasis, and hypercoagulability. This clas-
ably higher when considering the harm to sic framework can be used to understand the eti-
patients. ology of risk factors that predispose patients to
VTE. Vascular endothelial injury may be iatro-
genic (e.g., central venous catheter, surgery) or
Harm to Patients traumatic. Venous stasis results from factors
causing immobilization such as bed rest, pro-
Post-thrombotic syndrome, chronic thromboem- longed sitting, stroke, immobilization (i.e., long-
bolic pulmonary hypertension, recurrent VTE, bone stabilization for trauma), pharmacologic
and risks of anticoagulation treatment are only paralysis, or traumatic paralysis (e.g., spinal cord
some of the harms associated with VTE [9, 28, injury). Hypercoagulability may be inherited
29]. Post-thrombotic syndrome may affect as (e.g., factor V Leiden) or acquired (e.g., malig-
many as 23–60 % of patients with DVT [27]. nancy, hormone/contraceptive use). Specific
Symptoms include chronic calf swelling and skin major and minor risk factors are listed in
Table 29.1 Risk factors for venous thromboembolism complex but is derived from a relatively small
Major VTE risk factors study in a single Italian hospital [36].
• Malignancy
• Personal history of previous VTE
• Family history of VTE
• Prolonged surgical procedure (>2 h)
Prevention
• Major general surgery
• Major traumatic injury Pharmacologic Prophylaxis
• Hip or leg fracture
• Hip or knee replacement
• Acute spinal fracture
Guidelines for VTE prophylaxis are available and
• Acute spinal cord injury (<1 month) widely disseminated. The guidelines from the
• Acute stroke (<1 month) American College of Chest Physicians (ACCP)
• Pregnancy/postpartum (up to 6 weeks) are often considered the definitive resource [11].
• Known thrombophilia (e.g., factor V Leiden, lupus
anticoagulant, anticardiolipin antibodies, antithrombin
This group has specific recommendations for pro-
deficiency, protein C or S deficiency, etc.) phylaxis in non-orthopedic surgery patients [39].
• Central venous catheter Guidelines for specific populations at risk, such as
• Respiratory failure/mechanical ventilation trauma patients and orthopedic surgical patients,
Minor VTE risk factors are available from specialty societies such as the
• Older age Eastern Association for the Surgery of Trauma
• Bed rest
• Immobility from prolonged sitting (e.g., airplane (EAST) and the American Academy of Orthopedic
travel or prolonged car travel) Surgeons (AAOS), respectively [40, 41].
• Laparoscopic surgery Most protocols use subcutaneous (SC) injection
• Inflammatory bowel disease of unfractionated heparin or low molecular weight
• Obesity
• Pregnancy/antepartum heparins (LWMH) such as enoxaparin, dalteparin,
• Acute infection or fondaparinux for VTE prophylaxis. Trauma and
• Varicose veins orthopedic literature typically supports the use of
• Arteriovenous malformations LMWH over unfractionated heparin [40]. Patients
• Tobacco use
• Estrogen/selective estrogen receptor modulators with unstable renal function or creatinine clearance
(e.g., tamoxifen) less than 30 mL/min should receive unfractionated
• Contraceptives heparin instead of LMWH due to risks associated
VTE venous thromboembolism with bioaccumulation of some LMWHs in patients
with reduced renal clearance. Newer oral antico-
agulants are being promoted for VTE prevention,
although at this time, the only well-studied indica-
Table 29.1. The AHRQ recently published an tion is for patients undergoing hip or knee replace-
updated report “Preventing Hospital-Acquired ment surgery.
Venous Thromboembolism - A Guide for VTE prophylaxis should generally be pro-
Effective Quality Improvement” which promotes vided throughout the inpatient hospitalization,
accepted approaches for VTE prevention in hos- but some literature also supports extending pro-
pitalized patients [9]. This report summarizes phylaxis to the outpatient setting for a limited
numerous risk assessment models that have been duration after discharge from the hospital. This
created to stratify patient risk for acquiring VTE may be of particular use in patients at high risk
during hospitalization. University of California for perioperative VTE including orthopedic sur-
(UC) San Diego and Johns Hopkins employ a gery patients, or those with major abdominopel-
bucket model, while others use a point allocation vic oncologic resections. Dosing of unfractionated
system (e.g., Caprini, Padua, Rogers, IMPROVE) heparin is typically 5000 units SC every 8 h for
[14, 34–38]. The Caprini model is a complex many patients, while less frequent dosing (5000
scoring system but has been validated in surgical units SC every 12 h) may be appropriate for some
patients [35]. The Padua model is somewhat less patients at lower risk. Dosing for a common
LMWH, enoxaparin, is typically once daily with This recommendation may apply to patients with
40 mg SC for most surgical patients yet should be both increased bleeding risk and an injury pattern
30 mg twice daily for trauma patients [42]. VTE rendering them immobile for a prolonged period
prophylaxis is typically administered 1–2 h (e.g., severe closed-head injury, spinal cord
before any major surgical procedure and resumed injury with paraplegia or quadriplegia, or multi-
12–24 h postoperatively. Contraindications to ple long-bone fractures). However, there is con-
pharmacologic prophylaxis include active bleed- siderable disagreement on this topic, and the
ing, high risk of bleeding, systemic anticoagula- ACCP states that “for major trauma patients, we
tion, coagulopathy with international normalized suggest that an IVC filter should not be used for
ratio (INR) ≥1.5, or thrombocytopenia (platelet primary VTE prevention (Grade 2C)” [39].
count <50,000). While the trauma literature has identified a
potential benefit, IVC filters may also be associ-
ated with increased morbidity and mortality in
Mechanical Prophylaxis other patient populations. In the bariatric surgery
literature, prophylactic IVC filters are associated
Mechanical prophylaxis may include sequential with higher mortality and higher risk of DVT
compression devices (SCDS) and thromboem- [46]. Further research is needed to truly under-
bolic deterrent stockings (TEDS). SCDS are pre- stand the implications and safety considerations
ferred over TEDS alone, and TEDS may be for IVC filter use in different patient populations.
associated with ulcers or skin breakdown, espe- If a retrievable IVC filter is used, it is impor-
cially in patients with stroke, peripheral vascular tant to remove the IVC filter as soon as the
disease, or chronic lower extremity wounds [43]. patient’s acute risk of VTE decreases. In many
Compliance with these devices in surgical cases, patients do not return for IVC filter
patients is poor even without any specific contra- removal. One study of 446 trauma patients who
indications, and efforts to improve compliance by received retrievable IVC filters demonstrated that
addressing misconceptions will be discussed only 22 % actually had their IVC filter removed
later in the chapter. Although very little data sup- [47]. Filter endothelialization may occur as soon
port its use, ambulation has been suggested as an as 3 weeks after placement, yet many can still be
effective adjunct to VTE prophylaxis when fea- recovered years later. Patients may experience
sible [44]. However, this should not be consid- complications from prolonged indwelling IVC
ered an acceptable replacement to pharmacologic filters, including perforation of the IVC noted on
and/or mechanical prophylaxis in hospitalized subsequent CT imaging and strut fracture and
patients at risk for VTE. embolization [48, 49].
Numerous efforts are underway to identify
strategies to ensure better rates of filter retrieval.
rophylactic Inferior Vena Cava
P One group has applied the DMAIC (Define,
Filters Measure, Analyze, Improve, Control) methodol-
ogy of the Six Sigma paradigm and increased
Inferior vena cava (IVC) filters have been used as filter retrieval rates from a baseline of 8 to 52 %
prophylaxis in certain high-risk patients without by employing automated clinic visit scheduling
VTE who are unable to receive pharmacologic for 4 weeks after IVC filter placement [50]. A
prophylaxis. The strongest data for this indica- group in New Zealand implemented an “IVC fil-
tion come from the trauma literature [45]. EAST ter pathway” and increased retrieval rates from
offers a level III recommendation (based on ret- 63 to 100 % [51]. Focused efforts to improve
rospective data and/or expert opinion) that a pro- poor IVC filter removal rates in trauma have
phylactic IVC filter may be considered in very been successful and increased rates to 59 % at
high-risk trauma patients who are unable to one US hospital and 87 % at a Canadian trauma
receive pharmacologic VTE prophylaxis [40]. center [52, 53].
ystems of Care to Improve

S TE Risk Assessment and Prescription
V
Prevention of Prophylaxis
While guidelines for VTE prevention are widely One approach to improve documentation of VTE
available, VTE prophylaxis remains underuti- risk status and compliance with evidence-based
lized in a significant proportion of hospitalized guidelines is to utilize a mandatory computerized
patients [11, 40, 41]. One study included over provider order entry (CPOE) clinical decision
68,000 hospitalized patients at risk for VTE in support (CDS) tool, as suggested by the AHRQ
32 countries and determined that only 59 % of [8, 9]. Computer order entry system requires the
surgical patients and 40 % of medical patients prescribing provider to complete a checklist of
received guideline-recommended VTE prophy- VTE risk factors and contraindications specific
laxis [4]. As with most quality improvement for the patient. Based on this checklist, the patient
interventions, improved outcomes are best is risk stratified, and the appropriate prophylaxis,
achieved by evaluating the system of care and according to current guidelines, is determined.
identifying the component process measures. By The provider is then prompted to order the appro-
improving specific process measures, better out- priate prophylaxis regimen. This approach has
comes may follow. VTE presents an important demonstrated dramatic improvements in both pre-
example of how to improve healthcare quality scription of risk-appropriate VTE prophylaxis for
and patient safety through active interventions medical and surgical patients and an associated
targeting specific aspects of the system of care. decrease in the rate of preventable harm from
A basic framework for the VTE prophylaxis sys- VTE [14, 15]. When this strategy was imple-
tem of care includes risk assessment and pre- mented at the Johns Hopkins Hospital, compli-
scription of appropriate prophylaxis by a ance with guideline-appropriate prophylaxis in
provider, administration of all prescribed pro- trauma patients increased from 66.2 to 84.4 %
phylaxis doses by a nurse, and acceptance of all (p < 0.001), and the rate of preventable harm from
doses by the patient (Fig. 29.1). VTE decreased from 1.0 to 0.17 % (p = 0.04).
Fig. 29.1 VTE prophylaxis system of care and strategies for improvement (VTE, venous thromboembolism)
It is important to ensure that interventions patients who missed no doses of prophylaxis

designed to improve prescription of VTE prophy- (p < 0.01). A 2015 study examined 128 medical
laxis are targeted at the appropriate individuals. and surgical patients with hospital-acquired VTE
At many academic institutions, quality measures and determined that 72 % (92 patients) of these
attributed to attending physicians (e.g., rate of VTE events were potentially preventable [17].
compliance with appropriate VTE prophylaxis) The VTE events that were not preventable were
may actually reflect the average performance of attributed to the presence of a central venous
both highly compliant and noncompliant resi- catheter [57]. Of the 92 patients who experienced
dents. One study compared the proportion of potentially preventable VTE events, 79 (86 %)
risk-appropriate VTE prophylaxis orders written were prescribed optimal prophylaxis, yet only 43
by each resident and attributed to attending phy- (47 %) received defect-free care. Of the 49
sicians [54]. While there was no difference in patients (53 %) who were noted to have defects in
proportion of risk-appropriate VTE prophylaxis their care, 13 (27 %) were not prescribed risk-
when attributed to attending physicians, there appropriate VTE prophylaxis, and 36 (73 %)
was a significant difference among residents. missed at least one dose of appropriately pre-
Over half of the residents prescribed optimal pro- scribed prophylaxis. A retrospective review
phylaxis for every patient they admitted, but there examined the medication administration record
was a minority of residents (9.3 %) who failed to for patients prescribed VTE prophylaxis over a
prescribe optimal prophylaxis for any of the 7-month period at one academic medical center
patients they admitted. This study demonstrates [58]. Over 100,000 doses of VTE prophylaxis
the importance of targeting the providers actually were ordered, but 12 % of these doses were not
responsible for entering the prophylaxis orders. actually administered to patients. Patient refusal
Furthermore, this suggests that an educational was the most commonly documented reason for
intervention with the limited number of residents nonadministration in about 60 % of cases. This
not prescribing appropriate prophylaxis might be study also demonstrated that a small group of
most effective. Accordingly, a system designed patients (approximately 20 %) constituted the
to audit resident compliance with VTE prophy- majority (80 %) of all nonadministered doses.
laxis and provide individualized performance Heterogeneity in terms of administration of VTE
feedback was implemented and has been shown prophylaxis across nursing floors was noted
to significantly improve compliance with guide- which suggests that targeting interventions to
lines, reduce incidence of VTE, and improve resi- specific nursing floors, individual nurses, or indi-
dents’ satisfaction with their education [55]. vidual patients may be effective.
Administration of VTE Prophylaxis Patient Engagement and Education
Once risk-appropriate VTE prophylaxis is Many patients are not aware of VTE or its poten-
ordered, it does not necessarily mean that all tial consequences, which may lead some patients
ordered doses of prophylaxis will actually be to refuse VTE prophylaxis without a clear under-
administered. Even missing one dose of VTE standing of the risks and benefits of this decision.
prophylaxis is associated with VTE events as An APHA telephone survey established that
demonstrated by a 2014 analysis of 202 trauma fewer than one in ten Americans know about
and general surgery patients [56]. This study DVT and are familiar with its symptoms or risk
showed an overall incidence of DVT of 15.8 %, factors [6]. Recently, for World Thrombosis Day
and 58.9 % of patients had missed at least one (October 13, 2014), Wendelboe surveyed 7233
dose of prescribed VTE prophylaxis. DVT participants in nine countries to determine the
occurred in 23.5 % of patients who missed at awareness of VTE. They found awareness to be
least one dose of prophylaxis and in 4.8 % of lowest for DVT (44 %) and PE (54 %) compared
to other common conditions such as breast can- requires education of a broader multidisciplinary
cer (85 %), stroke (85 %), prostate cancer (82 %), group including nursing assistants, physical ther-
and heart attack (88 %) [59]. Initiatives to increase apists, occupational therapists, and transport
awareness among patients and the public are also teams. A common misconception held by some
important to decrease the incidence of VTE. For hospital staff and contributing to noncompliance
example, US Congress has designated the month is that SCDS may cause patient falls. A retro-
of March as DVT Awareness Month to help high- spective study examined the incidence of SCD-
light the symptoms of this common disease. related falls and determined that only 0.45 % of
Ongoing efforts must incorporate patient- falls in the hospital are related to SCDS and
centered interventions to ensure that patients SCD-related falls are not more harmful than
understand the importance of VTE prophylaxis other types of falls [63].
and the inherent risks associated with refusal of Active attempts to understand nursing prac-
prophylaxis. Recently, our group has been funded tices and beliefs identified barriers to administra-
to address this problem by the Patient-Centered tion of prescribed VTE prophylaxis in a mixed
Outcomes Research Institute (PCORI) for a proj- methods study published in 2014 [16]. The study
ect titled “Preventing Venous Thromboembolism: revealed a nursing belief that nurses are respon-
Empowering Patients and Enabling Patient- sible for assessing individual patient risks and
Centered Care via Health Information benefits of prescribed pharmacological VTE pro-
Technology” [60]. Patient educational materials phylaxis before administering the medication to
are readily available in both paper (http://www. the patient. One nurse who participated in a focus
Hopkinsmedicine.org/Armstrong/bloodclots) group during this study stated “We make the clin-
and video (http://bit.ly/bloodclots) formats, ical decision all the time as to whether a patient
which can be used for this purpose. needs VTE prophylaxis every day, based on how
much the patient is ambulating.” This study was
able to identify misconceptions held by many
Overcoming Hospital Culture nurses and introduced an opportunity to provide
Obstacles additional education to this group.
Efforts to improve VTE prophylaxis in accor-

dance with best-practice guidelines may require Public Reporting of VTE Outcomes
addressing obstacles attributed to hospital culture
[61]. For example, mechanical VTE prophylaxis Public reporting and pay-for-performance initia-
with SCDS is often prescribed but commonly tives are effective tools to improve the quality of
underutilized in about 50 % of patients [62]. healthcare [64, 65]. National bodies, including
Noncompliance may be largely related to patient the Centers for Medicare and Medicaid Services,
discomfort and the ease with which these devices impose financial penalties when hospitalized
may be removed by the patient. Another well- patients develop VTE, despite the fact that many
known contributing factor is lack of available of these VTE events are truly not preventable
SCD equipment at the time of patient admission. with current best-practice prophylaxis [19].
Some hospitals have addressed this issue by Furthermore, the incidence of VTE is related to
assigning SCD equipment to each hospital bed, screening practices and therefore subject to sur-
ensuring that the patient will be provided with veillance bias [66]. Providers who screen more
clean SCD equipment at the time the bed is made aggressively by performing more Duplex ultra-
available. There may be a tendency for multidis- sounds on asymptomatic patients at risk for VTE
ciplinary staff members to remove SCDS to help may identify more cases of VTE and will appear
a patient out of bed without reapplying the SCDS to provide lower-quality care than providers who
when returning the patient to bed. This problem do not screen or order fewer screening tests.
creening of Asymptomatic Patients

S suring incidence of VTE alone, some experts
and Surveillance Bias argue for a pure process measure approach or
combined process and outcome measure instead
There is no consensus regarding DVT screening [12, 13, 20, 21]. Outcome measures are of consid-
of high-risk asymptomatic patients, and practices erable interest and have been commonly used to
among surgeons may vary significantly [66]. determine the quality of care [70]. However, poor
ACCP does not recommend routine screening for outcomes provide no information about how to
DVT in critically ill patients [11]. EAST recog- actually address the underlying problem.
nizes that some patients at high risk may benefit Interventions to improve the quality of care must
from routine screening for DVT [40]. However, be directed at the process of care [71]. Using the
the clinical importance of asymptomatic DVT VTE and Outcome Measures example, linking the
detected by routine screening remains unclear. process measures (prescription and administra-
Supporters of routine screening see benefit in tion of risk-appropriate VTE prophylaxis) and the
performing a relatively inexpensive and noninva- outcome measure (incidence of VTE) estimates
sive test (Duplex ultrasonography), in order to one of the most valuable markers of patient safety
diagnose and treat asymptomatic DVT before it and excellent care: the true rate of preventable
progresses to symptomatic or fatal PE. Others harm [20, 21].
feel that increased medical testing, associated
costs, and treatment of asymptomatic DVT
(which may never have come to clinical attention uality and Safety Aspects
Q
otherwise) incur not only the risk associated with of Diagnosis and Treatment
anticoagulation but also unnecessary costs.
Surveillance bias (“the more you look, the DVT was historically diagnosed with invasive
more you find”) is a common concern when contrast venography, but in current practice, DVT
screening asymptomatic patients for VTE. Studies is almost exclusively diagnosed with Duplex
have clearly shown that increasing screening is ultrasonography. Duplex ultrasound is safe, non-
associated with increasing rates of VTE, primar- invasive, and relatively inexpensive. Similarly,
ily in trauma patients [20, 67, 68]. However, this invasive pulmonary angiography via right heart
phenomenon has also been shown in a large sam- catheterization was historically employed to
ple of nearly one million Medicare patients diagnose PE. This invasive, risky, and costly pro-
undergoing a wide range of surgical procedures cedure has been replaced with contrast-enhanced
[69]. While national and regional bodies recog- computed tomography (CT) angiography for the
nize low incidence of VTE as a marker of quality, diagnosis of PE. Current multidetector helical
this is a biased measurement since hospitals that CT angiography allows highly accurate diagnosis
less commonly screen patients for VTE are going of PE [72]. Furthermore, improvements in imag-
to identify fewer VTE events regardless of asso- ing modalities allow visualization of segmental
ciated healthcare quality. and subsegmental pulmonary arteries, although
the clinical importance of treating peripheral pul-
monary emboli is not certain.
inking Process Measures
L Other modalities utilized in the diagnosis of PE
and Outcome Measures may include ventilation/perfusion scan (V/Q scan)
or D-dimer assay. V/Q scan is a nuclear medicine
The standard of patient safety and quality care test sometimes used to diagnosis PE in patients
should not only focus on the incidence of VTE who are unable to undergo contrast-enhanced CT
(outcome measure) alone but also consider how secondary to renal insufficiency or severe contrast
frequently patients are prescribed and adminis- allergy. D-dimer assay is commonly used in emer-
tered VTE prophylaxis according to best-practice gency department patients and outpatients to rule
guidelines (process measure). Rather than mea- out VTE due to its high sensitivity. Fibrin D-dimer
measures the final product of the plasmin-mediated • National annual expenditures for treatment of
degradation of fibrin and is often elevated in VTE may be as high as $10 billion.
patients with acute VTE. However, D-dimer is also • Post-thrombotic syndrome is the most com-
common in many other conditions associated with mon long-term morbidity associated with
fibrin production including malignancy, trauma, VTE and may affect over half of patients with
infection, inflammation, and the postoperative VTE.
state. A negative D-dimer can help rule out the • Evidence-based guidelines for VTE prophy-
diagnosis, but a positive test is certainly not confir- laxis using pharmacologic and/or mechanical
matory for VTE, especially in hospitalized surgical prophylaxis are available and widely
patients. Both V/Q scan and D-dimer assay must disseminated.
be utilized in conjunction with a pretest probability • Not all VTE events are preventable, even with
assessment such as the Wells score or the Geneva optimal prescription and administration of
score to be clinically useful. risk-appropriate prophylaxis.
The Choosing Wisely campaign from the • Improved VTE prophylaxis decreases prevent-
American Board of Internal Medicine aims to able harm to patients.
decrease unnecessary healthcare expenditures • A true benchmark of patient safety and quality
and improve patient care [73]. Various medical care should not focus on the incidence of VTE
societies identify the top five tests or treatments alone, without considering how frequently
that are often ordered inappropriately or too fre- patients are prescribed and administered VTE
quently. The ACCP, in conjunction with the prophylaxis according to best-practice
American Thoracic Society, has encouraged pro- guidelines.
viders to “choose wisely” when ordering CT
angiography to screen for PE. They caution: “Do
not perform chest CT angiography to evaluate for
possible pulmonary embolism in patients with References
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Preventing Perioperative
Positioning and Equipment 30
Injuries
Lisa Spruce
“Injuries may be forgiven, but not forgotten.”

—Aesop Fables
• Provide optimal exposure for the surgeon

Introduction • Minimize patient risk
• Provide optimal physiologic monitoring and
Positioning the patient for surgery is an important IV access
aspect of patient care, and proper positioning • Keep patients safe and secure, avoiding injury
keeps patients safe. New types of surgery and • Maintaining patient dignity
innovative technologies continue to grow; in par- • Allowing for optimal ventilation and
ticular, robotic procedures and minimally inva- circulation
sive surgery pose unique challenges to safe
positioning practices. Research has shown that Many factors come into play when deciding
perioperative personnel can be implicated in what position to place the patient in; the surgeon
patient injury cases when a breach of the standard preference is one such factor, and other factors
of care is determined to be a causative factor [1]. may depend on the patient’s preexisting condi-
The Centers for Medicare and Medicaid Services tions such as arthritis, or joint problems, previous
(CMS) considers pressure ulcers to be a hospital surgery, decreased range of motion, fractures, or
acquired condition (HAC) and will not reimburse patient height, weight, and age [2]. These condi-
the facility’s related costs. tions should be identified prior to the com-
Prevention of injury requires anticipating the mencement of the surgical procedure. Positioning
needs of the patient along with the planned oper- requires precision and attention to detail as the
ative or invasive procedure and application of the possibility of patient injury exists at any time
principles of body mechanics, knowledge of during the surgical procedure.
anatomy and physiology, and assessment of the
patient’s body systems. Positioning requires the
skills and knowledge of every team member and Anatomy and Physiology
teamwork to prevent patient harm. The main
objectives for positioning patients are to: Many patients undergoing surgery require general
anesthesia. General anesthesia and the use of anes-
thetic gases depress the autonomic nervous system
causing some degree of vasodilation which
L. Spruce, DNP, CNS-CP, CNOR, FAAN (*)
reduces the mean arterial pressure [3]. All of the
Association of PeriOperative Registered Nurses,
2170 S Parker Rd, Denver, CO 80238, USA volatile anesthetic agents cause a dose-dependent
e-mail: [email protected] decrease in blood pressure [4]. The decrease in

494 L. Spruce
blood pressure with halothane and enflurane is will result in an occlusion of blood flow, thereby
mainly due to a decrease in stroke volume and car- inhibiting tissue perfusion with resultant ischemia
diac output, while the anesthetic agent’s isoflu- to the tissue [7]. Patients are immobile during sur-
rane, desflurane, and sevoflurane decrease gery and are not able to shift or change position
systemic vascular resistance but maintain cardiac and cannot voice discomfort therefore cannot play
output [4]. Other factors such as diuretic and anti- a role in prevention of injury and depend on peri-
hypertensive medication use, the use of bowel operative nurses and team members to be their
preps, nausea, vomiting, and a poor nutritional advocates. Patients are most often not positioned
state can further impact the drop in blood pressure in such a way that their body weight is evenly dis-
[2]. These physiological effects leave the patient tributed, and an increased risk of tissue damage is
vulnerable to pressure effects. Pressure is exerted present [8]. Areas of skin over bony prominences
on the body by the patient’s weight against the bed are particularly vulnerable to injury and are
surface and is exerted on the bone, muscle, soft enhanced in those patients who are thin or
tissue, and skin [3]. underweight.
Anesthesia has a profound effect on position- Patients must be positioned in such a way that
ing, and the anesthesia care provider will play an diaphragmatic movement and airway are not
important role in positioning the patient [5]. compromised. When lying supine, the anteropos-
Anesthesia, no matter the type, general, regional, terior diameter of the chest and abdomen
or local, blocks the patient’s response to pressure decreases, and the tidal volume and residual
and pain [2]. Careful questioning and examina- capacity of the lungs are decreased, thus there
tion of the patient are required to implement a should be no constricting devices around the
comprehensive plan of care for the patient, and chest or neck [6].
the patient should have an understanding of the Pressure injuries (see also Chap. 18) are the
impact of pressure on his or her body [2]. Patients most common cause of injury to patients fol-
with chronic conditions such as cardiac disorders, lowed by nerve injury. Most nerve injuries occur
diabetes, cancer, neurological disorders, respira- at the ulnar nerve and the plexus brachialis nerve
tory disease, and peripheral vascular disease are [8]. Other nerves that can be injured include the
particularly vulnerable to positioning injury and radial, perineal, and facial nerves which can all
will need extra caution. Older patients whose skin be stretched or compressed against bone or com-
is less elastic, thin with less muscle and fatty tis- ponents of the OR bed. Caution and awareness
sue are also more susceptible to pressure, bruis- must be taken when positioning body parts in
ing, skin tears, and infections. These patients need various holders or when manipulating them.
careful assessment by anesthesia care providers
and nursing team members to provide adequate
protection from these injuries [2]. Positioning Equipment
Positioning equipment should be designed for that

Risk Factors purpose and should protect, support, and maintain
the patient’s position in surgery. Additional pad-
One of the most significant risk factors that impact ding is used to protect bony prominences. Tape
patients who are positioned for surgery is the should never be used to secure a patient in surgery;
amount of time they spend on the operating room tape is not approved as a positioning device and
(OR) bed. Pressure and time are inversely related. using it in such as way could compromise the
Patients can tolerate a large amount of pressure patient’s safety and place the healthcare team at
for a very short period of time or a low amount of risk for liability should an injury occurs.
pressure for a longer period of time [6]. External Operating room mattresses provide a support
pressure that is consistently exerted on patient tis- surface (Fig. 30.1); these surfaces should be
sue at capillary pressures greater than 32 mm Hg designed in alignment with the recommenda-
30 Preventing Perioperative Positioning and Equipment Injuries 495
Fig. 30.1 Operating room mattress.

Reprinted with permission from Hill-Rom
Services, Inc
tions from the National Pressure Ulcer Advisory self-contouring copolymer gel and a bottom
Panel which states that “support surfaces should layer of high-density foam and a fluid immer-
be specialized devices for pressure redistribu- sion simulation surgical surface [12].
tion and design to manage tissue loads, micro- Perioperative team members should always
climate and other therapeutic functions” [9]. follow equipment manufacturer’s instructions for
Decisions on purchasing mattresses should be use including weight limits for beds and equip-
made by individual organizations based on the ment. There should be advanced preparation for
healthcare population of patients, current overweight and obese patients so there will be no
research, and equipment design and safety fea- delay in the planned procedure.
tures. The primary safety feature is that the sur- When planning care for patients, perioperative
face should redistribute pressure, especially at team members should review the patient’s plan of
the patient’s bony prominences [10]. A system- care and anticipate the positioning equipment
atic review done by Reddy looked at mattresses that will be required for each patient. This will be
or mattress overlays such as air, water, gel, determined by the procedure, surgeon’s prefer-
foam, or a combination of these or dynamic sup- ence, and the condition of the patient. Optimum
port surfaces (those that mechanically vary the positioning will allow exposure to the surgical
pressure under the patient) and found the site and access to all IV lines and monitoring
dynamic support surfaces decreased the inci- devices. The room should be set up appropriately
dence of pressure ulcer development [11]. A before the patient arrives, and the correct patient
study done by Kirkland-Walsh et al. compared position and equipment should be verified during
pressure mapping of four OR surfaces. The best the time-out process [10].
surfaces are those that provide not only efficient Perioperative team members should select
pressure redistribution but should also have surfaces that will minimize pressure over patient’s
low-peak interface pressure (pressure at the skin bony prominences [10]:
surface), low-average interface pressure, and the
highest skin contact area. The researchers deter- • Rolled sheets and towels should not be used
mined that the air-inflated static seat cushion beneath the procedure mattress or overlay.
had the best pressure redistribution properties in They do not reduce pressure and can in fact
the sacral region, compared to standard three- contribute to friction injuries.
layer viscoelastic memory foam, with two lay- • Pillows, blankets, and molded foam devices
ers consisting of a top layer of non-powered may only provide a minimum amount of
496 L. Spruce
ressure relief and are less effective for longer

p Table 30.1 Preoperative assessment
procedures. Preoperative assessment checklist
• Foam may be effective when not heavily Age
compressed. Weight
Height
Body mass index
Equipment and Positioning Injuries Nutritional status (decreased muscle mass,
dehydration, albumin level)
Often equipment injuries happen because periop- Blood pressure
erative team members fail to read the manufactur- Range of motion or physical limitations
er’s instructions for use [13]. In a classic study by Presence of internal or implanted devices such as
artificial joints or pacemakers
Reason, it was determined that there are 12 com-
Presence of external devices such as a colostomy bag
mon contributing factors to a mistake; the most or urinary catheter
common was misjudgment, followed by [13]: Presence of jewelry or piercings (remove before surgery)
Medical history including history of a previous injury
• Failure to check equipment preoperatively or pressure ulcer
• Faulty technique Results of lab and diagnostic tests
• Other human factors Psychological and or cultural issues
• Other problems with equipment AORN. Guideline for positioning the patient. In:
• Inattention Guidelines for Perioperative Practice. Denver, CO:
AORN, Inc; 2015:563–581
• Haste
• Inexperience
• Communication problems ough interview, a review of records, and a head-
• Inadequate assessment preoperatively to-toe assessment. Preexisting conditions should
• Problem with a monitor be identified as well as joint issues or implants,
• Inadequate preoperative preparation decreased range of motion, current or previous
fractures, neck or back problems, and any issues
Most mistakes are usually organizational in with numbness in the hands or arms [2]. The peri-
nature (i.e., the origin of the mistake can be traced operative nurse should have a thorough discus-
to a decision made before the mistake happened). sion with the patient and family if any of these
Therefore, it is up to individual institutions to conditions are present and how positioning may
understand the behaviors and risk reduction strat- impact those conditions and discuss how mea-
egies that can be implemented in each unique sures will be taken to minimize impact on those
situation [13]. Facilities can focus on teamwork conditions [2]. The preoperative assessment
and communication, issues with equipment and checklist is listed in Table 30.1 [10].
maintenance, and coordination and planning
among perioperative team members [14] (for
detailed discussion, refer to other chapters on Skin Assessment
teamwork, communication, or human error).
A skin assessment should be part of the routine
assessment of all patients; additional precautions
Preoperative Assessment should be taken to decrease the risk of pressure
ulcers in patients who [10]:
A comprehensive preoperative assessment should
take place prior to the patient being sedated. The • Are more than 70 years of age
process should involve the patient and family • Require a procedure lasting longer than 4 h or
members present and should consist of a thor- undergoing a vascular procedure
• Are thin, of small stature, or who have poor In all positions, padding should be used to
nutrition protect the patient’s bony prominences, and the
• Have vascular disease or are diabetic limbs should be positioned to protect them from
nerve damage. Most injuries to the nerves are
When assessing the skin, assess for the fol- caused by improper patient positioning [15].
lowing [9]: There are different types of nerve injuries and
they are listed in Table 30.3 [15].
• Skin temperature One of the most common positioning injuries
• Edema is to the brachial plexus (Fig. 30.2) and can occur
• Change in tissue consistency in relation to the from several etiologies. The use of a shoulder
surrounding tissue brace can cause this type of injury when a patient
• Redness is placed in steep Trendelenburg. If the shoulder
• Pain brace is placed too lateral, a stretch injury can
occur. If placed too proximal, a compression
Document any areas that meet the conditions injury can occur due to the shoulder brace press-
above and take additional steps as needed such as ing the brachial plexus against the first rib.
placement of extra padding and other pressure- Therefore, the use of a shoulder brace is not rec-
relieving devices and try not to position patients ommended [15]. There has not been any proven
on areas of redness if possible. method of preventing this type of injury when a
patient is placed in steep Trendelenburg. A sys-
tematic review done by Codd et al. stated that
Surgical Positions: Safety stretching was the principal mechanism of injury,
Considerations and minimizing the amount of time that a patient
remained in the position may help reduce the risk
With any position, perioperative team members of injury to the brachial plexus. If necessary,
should provide the patient with privacy and dig- returning the OR table to the neutral position
nity while transporting, transferring, and posi- when head down may help to reduce the pressure
tioning. The entire team is responsible for patient on the nerve [16]. Improper positioning of the
safety and privacy. Safety and privacy consider- upper extremities on arm boards can also cause
ations by team members are listed in Table 30.2. this type of injury. There is risk of a compression
The entire perioperative team should be or stretch injury because the brachial plexus runs
involved in moving and positioning the patient. posterior to the humeral head. If the arm is
Care should be taken not to slide or pull the patient abducted greater than 90°, then a stretch injury
which can result in shearing forces or friction on can occur. Patients experiencing this type of
the patient’s skin. Shearing can happen when the injury can experience numbness and tingling or a
patient’s skin stays stationary and the underlying complete inability to move the arm; wrist drop
tissues shift or move which can happen if a patient may also occur [15].
is dragged or pulled without support or if using a Another common injury that can occur is an
drawsheet. Friction occurs when skin surfaces rub injury to the ulnar nerve (Fig. 30.3). The ulnar
over stationary surfaces [10]. The team should be nerve is located in the olecranon groove as it
communicating at all times throughout the pro- crosses the elbow. The groove is located posteri-
cess, and patient needs should be identified. Tubes, orly between the medial condyle of the humerus
drains, catheters, and other devices should be and the olecranon process of the ulna. The ulnar
secured prior to transferring or positioning the nerve is covered by soft tissue leaving it vulner-
patient. Make sure the patient’s body is maintained able to injury. An ulnar injury can occur when the
in alignment and is supported at the extremities arms are tucked at the patient’s side. If the arms
and joints and the patient’s airway is maintained. are not correctly positioned and secured, the arm
Make sure there are enough people present to can migrate down and press against the edge of
transfer and position the patient safely [10]. the table causing the nerve to be compressed.
498 L. Spruce
Table 30.2 Safety considerations by team member

Circulator Surgeon Anesthetist
Restrict access to patient care areas Expose only the areas of the patient’s Airway is positioned correctly and is
to designated personnel only body that are necessary to access the patent; patient is ventilating
surgical site or provide care adequately
Keep doors closed Provide care without prejudice Monitors are in place, and IV lines
are patent
Limit traffic in and out of the Communicate with team when a Patient’s eyes are closed and
procedure room position change is necessary protected
Provide care without prejudice Participate in moving and positioning Tubes, lines, and catheters are
the patient secure
Keep conversation to a minimum Verify position and placement of Conversation is kept to a minimum
extremities
Assess position and function of all Provide care without prejudice
equipment
Implement precautions to decrease Assure adequate staff is present
the risk of pressure ulcers before moving or positioning the
patient
Make sure safety straps are secure
but not too tight
AORN. Guideline for positioning the patient. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc;
2015:563–581
Knight D, Mahajan R. Patient positioning in anaesthesia. Continuing Education in Anaesthesia, Critical Care & Pain.
2004;4(5):160–163
Table 30.3 Types of nerve injuries prevent compression of the ulnar nerve, and extra
Neurapraxia Axonotmesis Neurotmesis padding can be applied to the elbow.
A mild injury A more severe The most severe Other safety considerations are presented in
which may cause injury that injury caused by Table 30.4.
a conduction damages the a transection or
block across a axon of the ligation of the Injury to a patient’s eyes is of particular con-
small area of the nerve and is nerve and is a cern; direct pressure on the eye should be avoided
nerve and is caused by complete to reduce the risk of central retinal artery occlu-
caused by profound interruption of sion and other damage to the eye such as a cor-
external compression or the nerve and
compression to traction on the supporting neal abrasion. Patients who are at increased risk
the nerve nerve structures for developing postoperative visual loss are those
Bradshaw A, Advincula A. Postoperative Neuropathy in that are undergoing prolonged procedures greater
Gynecologic Surgery. Obstetrics and Gynecology Clinics than 6.5 h and those who experience a blood loss
of North America. 2010;37(3):451–459 greater than 44.7 % of estimated blood volume or
those who are positioned prone [10].
Patients at risk for this injury should be posi-
Before tucking a patient’s arms, the forearm tioned with their heads level with or higher than
should be pronated so that the olecranon groove their hearts, and the head should be maintained in
is rotated both outward and lateral which will a neutral forward position without significant
protect the nerve from compression. Placing flexion, rotation, or extension. The use of a horse-
extra padding at the elbow before the arms are shoe headrest may increase the risk of injury [10].
tucked will add additional protection [15]. To reduce the risk of injuries to the extremi-
Additionally when placing the patient’s arms on ties, the safety precautions that should be fol-
arm boards, the forearm should be supinated to lowed [10] are shown in Table 30.5.
Fig. 30.2 Brachial plexus nerve
Fig. 30.3 Ulnar nerve
Supine Position is initially placed in the supine position for induc-

tion and then repositioned as necessary. Many
The supine position is the most commonly used surgeries performed in this position are general
surgical position (Fig. 30.4). Almost every patient surgery; reconstructive or plastic surgery; proce-
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Table 30.4 Safety considerations resistance, heart rate, functional residual capac-
There is a risk of injury to the patient’s fingers, and ity, and total lung capacity. There is an advantage
therefore the location of them should always be to patients positioning themselves in the supine
confirmed before repositioning the bed or raising and
position as they can verbalize any discomfort,
lowering the feet
and adjustments can be made as needed such as
Safety restraints should be applied in such a way so
there is not compression or interference with blood flow placing a pillow under the knees. As noted previ-
Make sure the patient does not come into contact with ously, there is an increased pressure on the
metal on the OR bed elbows, heels, and sacrum. The ligaments of the
Make sure the patient’s heels are elevated and are not spinal column relax with induction agents and
touching the underlying surface of the bed can result in back pain. Additionally, the back of
Align the patient’s head and upper body with the hips; the head is under pressure, and patients can expe-
legs should be parallel and not crossed at the ankles
rience pressure alopecia [2].
Position the head in a neutral position on a head rest; a
pillow may be placed under the patient’s knees to If patients do not walk back to the procedure
relieve pressure on the low back room but are transported on a stretcher, a lateral
Pregnant patients should have a wedge inserted under transfer will be performed. Use a lateral transfer
the right side to displace the uterus to the left and device such as a slider board or air-assisted trans-
prevent compression of the aorta and vena cava fer device (Figs. 30.5, 30.6, and 30.7). The fol-
causing supine hypotensive syndrome
lowing recommendations should be followed
AORN. Guideline for positioning the patient. In:
Guidelines for Perioperative Practice. Denver, CO:
regarding team members required to safely trans-
AORN, Inc; 2015:563–581 fer patients [10]:
Patients up to 52 lbs: one perioperative team

member and one anesthesia care provider
Table 30.5 Safety precautions for the extremities Patients up to 104 lbs: two perioperative team
members and one anesthesia care provider
Padded arm boards should be used and attached to the
bed at less than a 90° angle for patients who are Patients up to 157 lbs: three perioperative team
positioned supine members and one anesthesia care provider
Place the patient’s palms facing up with the fingers
extended when on arm boards Patients who weigh more than 157 lbs:
When the arms are placed at the sides, they should be three perioperative team members and one
in a neutral position with the elbows slightly flexed,
wrists neutral, and palms facing inward
anesthesia care provider and use a mechanical
Keep shoulders neutral and avoid abduction or lateral lifting device such as a mechanical lift with a
rotation supine sling (Fig. 30.8), mechanical lateral
Prevent extremities from dropping below the bed transfer device, or air-assisted lateral transfer
Adequate padding should be provided when a patient device.
is positioned laterally or in lithotomy to prevent injury When moving a patient in and out of a sitting
to the saphenous, sciatic, and perineal nerves or modified-sitting position (Fig. 30.9), three
When a patient is positioned on a fracture table, a healthcare providers should work together to
well-padded perineal post should be placed against the
perineum between the genitalia and the uninjured leg move a patient up to 67 lbs and use a mechanical
lifting device with three team members if a
patient weighs 68 lbs or more [10].
dures involving the anterior chest, pelvis, or epi- The areas prone to pressure (Fig. 30.10)
gastrium; orthopedic procedures on the knees, should be adequately padded, and the patient’s
feet, hands, and forearms; and some neurosurgi- arms should either be extended on arm boards or
cal procedures such as anterior cervical or cranial secured at the patient’s sides. When tucking the
procedures [2]. When a patient walks back to the arms close to the body, the palms should face the
procedure room and then lies down in the supine body, and the drawsheet is brought up over the
position, they experience a decrease in vascular arms and tucked smoothly under the patient’s
Fig. 30.4 Supine position
Fig. 30.5 Slider board.

Reprinted with permission
from Hill-Rom Services, Inc
body not the mattress (Fig. 30.11). This method If the arms are placed on arm boards, they
helps to prevent the patient’s arms from falling should be extended no more than 90° to prevent
down outside the mattress. Arms are tucked in an injury to the brachial plexus (Fig. 30.13). Arm
this manner because the combined weight of the boards should be padded, and the pad level
mattress and the patient’s body could impair cir- should be equal to the OR bed. Palms should be
culation and cause nerve torsion and increase the facing up to prevent pressure on the ulnar nerve.
risk for compartment syndrome. Compartment Wrist restraints should be used to secure the arms
syndrome is caused from excessive pressure but should be padded and loosely applied. The
inside an enclosed space in the body. Blood flow safety strap should be placed across the thighs
is impeded and causes damage to the underlying approximately two inches above the knees with a
tissues which may require surgery and could blanket or sheet between the strap and the
result in permanent damage (Fig. 30.12). patient’s skin. The patient’s heels should be ele-
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Fig. 30.6 Slider board in use.

Reprinted with permission
from Hill-Rom Services, Inc
Fig. 30.7 Air-assisted transfer

device. Reprinted with
permission from Hill-Rom
Services, Inc
vated. From the supine position, patients can be tions from the supine position, changes should be
positioned into the lawn or beach chair position made slowly to allow for hemodynamic compen-
which is oftentimes used with shoulder sation to prevent hypotension. Additionally, after
procedures because it allows anterior and poste- every patient movement, reposition, or changing
rior access to the shoulder joint (Fig. 30.14). positional devices, the perioperative team should
When transitioning patients into different posi- reassess the patient, making sure that there is still
Fig. 30.8 Mechanical lift with supine sling.

Reprinted with permission from Hill-Rom
Services, Inc
Fig. 30.9 Sitting position

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Fig. 30.10 Areas prone to pressure
Fig. 30.11 Tucking the arms
good body alignment and a recheck of all pres- began placing patients in this position because it
sure points [17]. allowed better access to the organs of the pelvis.
Today the position is used often in robotic sur-
gery during gynecological, urogynecological,
Trendelenburg Position and gynecology-oncology procedures. Patients
placed in this position are at risk for injuries
This position can be defined as one where patients involving the eyes, nerves, and extremities (i.e.,
are positioned with the head down 15°–30° or compartment syndrome and rhabdomyolysis (the
30°–40° in steep Trendelenburg and feet down in breakdown of muscle tissue that leads to muscle
reverse Trendelenburg (Figs. 30.15 and 30.16). fiber contents being released into the blood-
The position is named after a German surgeon stream)). One study found that there is a low
Friedrich Trendelenburg who in the mid-1800s incidence of complications related to this posi-
Fig. 30.12 Compartment
syndrome
shift in fluids into the thoracic cavity with an

increase in central venous pressure; [19] this is
quickly followed by an increase in stroke volume
and cardiac output and results in a decrease in
heart rate and blood pressure. The addition of a
pneumoperitoneum can cause other circulatory
problems such as decreased venous return,
increased systemic vascular resistance, and
increased mean arterial pressure. These may have
an adverse effect on patients who are elderly or
have preexisting cardiac disease [19].
Positioning injuries can occur due to various
mechanisms such as neural-mediated injuries and
vascular mechanisms of injury. As discussed
above, peripheral nerve injuries range from mild
Fig. 30.13 90° arm placement
to severe and are caused by stretching, compres-
sion, or ischemia. Upper extremity injuries can
occur due to high body mass index (BMI) and
tucking of the arms. Oftentimes, if a robot is
tion; however, when complications do arise, they being used, the view of the patient can be blocked,
place a huge burden on facilities as well as and the robotic arms may compress the patient or
increase the patient’s length of stay [18]. the patient may slip down. Bean bag devices are
Oftentimes, patients are placed in steep sometimes used to prevent slippage, but there is
Trendelenburg as well as the lithotomy position controversy over whether using this type of
and also have the induction of a pneumoperito- device increases or decreases the risk of nerve
neum for prolonged periods. Changes in both the damage [20]. There are products on the market to
sympathetic and parasympathetic nervous sys- prevent patient slippage, and facilities should
tems occur immediately following placing the evaluate them on the risk and benefit to determine
patient in the steep Trendelenburg position. The which product to use (Fig. 30.17). Shoulder
body’s initial response is that there is an instant braces should not be used because they contrib-
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Fig. 30.14 Lawn or beach chair position
Fig. 30.15 Trendelenburg’s
position
Fig. 30.16 Reverse
Trendelenburg’s position with
foot rest
Fig. 30.17 Products used to prevent

slipping. Reprinted with permission from
Hill-Rom Services, Inc
ute to stretching of the brachial plexus and Modifiable Risk Factors

median nerves. Pressure from shoulder braces and Prevention
increases the mechanical loading on the brachial
plexus and can cause injury [20]. Patient Factors
Compartment syndrome is a vascular-
mediated injury that can be seen in this position. Elevated BMI is one risk factor for all types of
Due to the extreme positioning and a decrease in injuries. If time allows, patients should be
blood pressure, tissues may become hypoper- instructed to lose weight prior to undergoing sur-
fused. Ischemic conditions can occur such as gery. Optimal medical management should also
when the calves are compressed in stirrups. be in place for patients who are diabetic or have
Pressure increases on the calves, and blood flow peripheral vascular disease as these patients are
is decreased causing muscle and nerve damage. at increased risk of nerve damage [20].
As the dying muscle cells release particles, more
water is attracted into the area increasing the
pressure even more. Once the area is reperfused, Padding
toxic intracellular contents are released into the
patient’s bloodstream causing rhabdomyolysis Adequate padding of all pressure points as dis-
which can lead to renal failure [20]. cussed previously applies to this position as
Postoperative vision loss can also occur related well. Patients with a high BMI can have their
to steep Trendelenburg and in prone positioning arms padded using a well-padded arm sled.
[21]. The gravitational forces encountered in the Avoidance of extreme extension, flexion, or
steep head down position may cause venous sta- abduction should also be a high priority. Padding
sis, facial edema, and increased intraocular pres- the occiput such as with a gel donut will help to
sure leading to ischemic optic neuropathy which avoid ischemic necrosis of the scalp and subse-
can result in permanent vision loss [20]. quent hair loss.
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Positioning Devices During robotic procedures, a robotic time-out

and checklist can be completed after the robot
Use padded arm boards and limit arm abduction has been docked but prior to the start of the pro-
to 90°, or arms should be tucked. A padded foot cedure. This will allow the team to assure that
board should be used in the reverse trendelenburg standard positioning requirements are met such
position (Fig. 30.17). Using a non-sliding mat- as position of the extremities, type and location
tress under the patient should help to prevent of padding and restraints, any planned position
movement. One study found that the degree of changes during the procedure, and the proxim-
slope could be decreased to an average of 16° ity of the robotic arms to the patient. A checklist
versus 30°–40° and was sufficient to provide ade- such as this may aid the team to recognize risk
quate surgical exposure [22]. factors and prevent injury [20]. Song and col-
leagues conducted a literature review to deter-
mine complications associated with extended
Team Communication robotic operations that required prolonged time
in the OR. The study team developed a checklist
Communicating with all members of the team is for a second time-out that included nursing,
a high priority [23]. Patients who are at increased anesthesia, surgeon, and patient factors [24].
risk for positioning injuries oftentimes have The second time-out takes place after about
mild to severe systemic illness and all team 3–4 h and is beneficial to the surgeon who is not
members should be aware of the patient’s under- at the bedside and who may become unaware of
lying medical condition. Patients who have operative time and what is happening at the bed-
severe illness should be in the steep side. This time-out gives the entire team a
Trendelenburg position the shortest time possi- chance to evaluate the progression of the sur-
ble and should be frequently rechecked to make gery, identify potential risk to the patient, and
sure their position has not been compromised. understand what factors are contributing to the
Anesthesia providers should make sure these extended OR time. Team considerations are pre-
patients have optimal fluid management [22]. sented in Fig. 30.18.
Fig. 30.18 Surgical safety checklist

Prone Position patients is postoperative vision loss (POVL)

[21]. Patients can experience brachial plexus
The prone position is required for many surger- and cervical spine injuries as well. The main
ies such as laminectomy in the prone position, mechanism of injury for POVL is the effect of
or surgeries that require access to the back or hemodynamic changes on intraocular perfusion
rectal area. Sometimes, these patients are pressure (IOPP) [25]. Agah et al. conducted a
placed into a form of the prone position called study that measured the intraocular pressure
the jackknife or Kraske’s position (Figs. 30.19 under general anesthesia and in the prone posi-
and 30.20). Positioning a patient prone has tion and found that there was a linear relation-
many safety considerations. One of the most ship between IOP rise and the duration of the
devastating injuries that can occur in these prone position [25].
Fig. 30.19 Prone position with pressure points
Fig. 30.20 Jackknife or

Kraske’s position
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To prevent injury in the prone position, the peri- • Male genitalia should be protected by making
operative team should make sure that the patient’s sure they are free from pressure.
eyes are protected, avoiding pressure on the eyes • Pendulous skin folds should be checked to
and avoiding the use of a horseshoe headrest. The assure they are not trapped under the patient.
patient’s eyes should be assessed on a regular basis. • Pad the knees.
Risk factors associated with eye injuries include • The patient’s toes should be elevated off of the
being in the prone position, the length of the proce- bed by placing padding under the shins.
dure, and significant blood loss during the proce- • Place the arms at the patient’s sides or on arm
dure [26]. To reduce the risk of injury, the following boards placed at less than 90° at the shoulder
precautions should be taken [26]: with elbows flexed and palms facing down.
• Hands and wrists should be kept in normal
• Place a headrest under the patient’s head to alignment.
provide access to the airway and prevent eye, • Avoid placing the patient’s arms above the
forehead, and chin injury by decreasing exces- head.
sive pressure. • A stretcher or cart should be immediately
• Cervical alignment should be maintained by available in case emergency repositioning to
keeping the head in a neutral forward position the supine position is required such as with
without significant neck flexion, extension, or cardiopulmonary resuscitation.
rotation.
• Place two large chest rolls from the patient’s
clavicle to the iliac crest. This raises the weight Lithotomy Position
of the body off of the thorax and abdomen and
allows for free expansion of the lungs. The lithotomy position is most often used for
• Female breasts should be protected by apply- procedures of the pelvis and genitourinary tract
ing soft ventral supports on the lateral sides of and for combined abdominal and perineal proce-
the breasts diverting them toward the midline. dures (Fig. 30.21). There are varying degrees of
Fig. 30.21 Lithotomy
position
Fig. 30.22 Types of stirrups
lithotomy (low, standard, and exaggerated) and members must be diligent in positioning patients
different stirrup types, depending on type of pro- correctly in stirrups, making sure that the thighs
cedure and surgeon preference (Fig. 30.22). All are not overly abducted or rotated so the hips are
degrees of this position require repositioning of not hyperflexed beyond 80° or 90°. Assistants
the legs. When the legs are raised above the heart, must also be educated about the danger of lean-
blood will be directed to the central circulation ing against the patient’s lower extremities [15].
which will result in an increase in cardiac output The perineal nerve crosses laterally over the
and venous return. Intra-abdominal pressure will knee joint and then wraps around the fibular head
be increased limiting the movement of the dia- as it enters the lower leg. Compression of the
phragm resulting in decreased lung volumes [2]. nerve can occur from incorrect positioning. If a
Because of this, when the patient’s legs are patient’s knees or lower legs are allowed to press
raised, move them slowly and simultaneously to against a hard surface such as the candy cane stir-
allow the body to physiologically adjust to the rups, the nerve can press against the fibular head
sudden shift in circulatory volume. The nerves at and be compressed. It is important to inspect the
risk for injury are the femoral, saphenous, obtu- lower legs when the patient is placed in the stir-
rator, and perineal nerves (Fig. 30.23). Candy rup and pad the knee to prevent an injury [15].
cane stirrups can cause injuries to the femoral When patients are placed in the exaggerated
nerve due to excessive hip flexion or extreme lithotomy position, the pelvis is elevated and the
abduction and external rotation of the thighs legs extend higher than the body. This position
(Fig. 30.24). The femoral nerve may become puts stress on the lumbar spine and can cause the
angulated and compressed against the inguinal ligaments and muscles of the lower back to
ligament causing injury [15]. Another mecha- stretch. The legs and feet have a dramatic
nism of injury to the femoral nerve is when surgi- decrease in perfusion as well as an increase in
cal assistants have leaned on the patient’s inner pressure in the abdomen. Careful and controlled
thighs during the procedure. Perioperative team intubation and ventilation are required [2].
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Fig. 30.23 Nerves at risk for

injury
Fig. 30.24 Candy cane stirrups
Procedures lasting a long time put the patient at careful protection of the fingers is required. The
risk for compartment syndrome of the legs. fingers can migrate over the edge of the bed, and
The arms may be positioned as noted above on there is a significant risk of trauma to them as the
either arm boards or tucked. If tucking the arms, foot of the bed is raised. Protecting the hands and
Fig. 30.25 Mechanical device

with support sling
fingers can be achieved by using a foam heel pro- rax (Fig. 30.26). After anesthesia induction, the
tector to prevent the fingers from slipping out [2]. patient is carefully turned so that the operative
Other safety considerations for this position side is facing up. The patient is at risk for injury
[10]: of the spine due to misalignment as well as pres-
sure injury to the ears, acromion process, lateral
• Place stirrups at even height. knee, iliac crest, greater trochanter, and malleo-
• Position the patient’s buttocks at the lower lus (Fig. 30.27) [10]. Three caregivers should
break in the procedure bed that securely sup- help with turning the patient to avoid injury to
ports the sacrum. Confirm this position prior the suprascapular nerve. The anesthesia pro-
to starting the procedure. vider and one caregiver should support the head
• Position the patient’s heels in the lowest posi- and neck and maintain the airway during lateral
tion possible. positioning [10]. Place a small roll below the
• Support should be over the largest surface axilla so that the chest is lifted and there is ade-
area of the patient’s legs. quate blood flow to the arm and the axillary
• The legs should not rest against the posts of nerves are not compressed [2]. A pillow placed
the stirrups. under the patient’s head will help to keep the
• Exercise care to avoid shearing when reposi- thoracic and cervical vertebrae aligned, make
tioning the patient. sure the ear is not folded and is well padded.
• A minimum of two caregivers should be used The eyes must also be free from pressure and
to lift the legs. If needed, use mechanical protected [2]. The lower leg should be flexed
devices such as support slings to assist with with a foam pad placed under the fibular head to
lifting (Fig. 30.25). protect the perineal nerve; the upper leg is
extended and a pillow should be placed between
the legs [2]. The lower knee, ankle, and foot
Lateral Position should be padded. The arms can be placed on
either one or two arm boards. If two are used,
The lateral position is most often used for ortho- the lower arm should be placed palm up, and the
pedic procedures that involve the hip and the upper arm should be on the same plane as the
modified lateral position for the kidney and tho- shoulder with the wrist and forearm in a neutral
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Fig. 30.26 Lateral position
Fig. 30.27 Lateral position with pressure points
position. If one lower arm board is used, a pil- positioned in a modified lateral position such as
low should be placed between the arms to keep when exposure to the thorax or kidneys is
them aligned [2]. When transferring the anes- required, the following safety strategies should
thetized patient into and out of the lateral posi- be followed [2]:
tion, three caregivers plus the anesthesia care
provider can safely position a patient weighing • Stabilize the torso with padded braces.
115 lbs; if more than 115 lbs, lateral positioning • Flex the lower part of the bed to expose the
devices should be used [10]. When patients are thoracic area.
• For kidney exposure, the upper and lower Obese patients have special issues that need to
parts of the bed are flexed, and the kidney rest be considered when positioning them, these
is raised. include [10]:
• Position the patient so the kidney rest is under
the dependent iliac crest. If the kidney rest is • Airway may be compromised due to a short,
under the patient’s flank, the lower lung will thick neck.
be severely compromised. • Possibility of a difficult intubation.
• Use compression stockings to minimize the • Increased intra-abdominal pressure on the
systemic effect of the lowering of the lower diaphragm.
extremities below the heart. • Increased risk of aspiration and hypoxia.
• Increased risk of compression of the vena cava.
• Increased pulmonary artery pressure and car-
Positioning the Obese Patient diac output.
The Centers for Disease Control and Prevention

(CDC) defines obesity as weight that is consid- Safety Considerations
ered higher than a healthy weight with a body
mass index of greater than 30 kg/m2 [27]. In addition to all of the precautions noted thus
Obesity has been increasing in incidence, and it far, there are additional safety considerations for
is now estimated that more than one third of US the obese patient. First and foremost is the oper-
adults are obese [27]. Morbidly obese patients ating or procedure bed. The beds should be capa-
typically have comorbid conditions such as dia- ble of supporting and moving obese patients.
betes type II, hypertension, and arthritis of Beds should be capable of managing patients
weight-bearing joints, sleep apnea, atheroscle- weighing up to 800–1000 lbs. Specialized
rosis, alveolar hypoventilation, gastroesopha- hydraulics should be available and capable of
geal reflux disease, and urinary stress lifting these patients (Figs. 30.28 and 30.29).
incontinence [10]. Obese patients have been Mattresses should provide sufficient padding and
shown to have higher complication rates and support, and extra wide and long safety straps
longer hospital stays following surgeries than should be used to secure the patient. Two safety
normal weight patients [28]. straps can be used if necessary, one placed across
Obese patients require a careful preoperative the thighs and the other across the lower legs
assessment to identify issues that may adversely (Fig. 30.30) [31]. When placing the patient’s
affect them such as the inability to tolerate cer- arms on arm boards, it may be difficult to deter-
tain positions, joint or range of motion issues, mine if they are positioned at less than 90°, there-
and conditions of the skin or circulatory system fore padded arm sleds or toboggans may be used
[29]. Perioperative team members should estab- to allow the patient’s arms to be secured at the
lish a plan when caring for this population; addi- side of the body. Precaution should be taken to
tional staff members will need to be available to make sure these devices do not cause excessive
help move and position the patient and ensure pressure on the patient’s arms. Safety consider-
that all equipment necessary is available and ations for obese patients based on position are
checked for safety [29, 30]. noted in Table 30.6.
Fig. 30.28 Bariatric assist
device
Fig. 30.29 Bariatric assist device
Fig. 30.30 The use of two safety straps

Table 30.6 Safety considerations for obese patients

Supine position Prone position Trendelenburg Reverse trendelenburg Lithotomy
It may be difficult for Support the upper Avoid if possible Patient’s feet should Stirrups may be
obese patients to chest and pelvis to because the abdominal be placed on a foot used and should
tolerate this position free the abdominal contents press against board be designed for
due to additional viscera to reduce the diaphragm and can the obese patient
weight on the the pressure on the cause respiratory
respiratory and inferior vena cava compromise
circulatory systems, and the diaphragm
and patients may have
to be repositioned into
a sitting or lateral
position
Placing patients Increased blood flow Care should be taken Several staff
laterally allows the from the lower to make sure the feet members should
panniculus to be extremities to the are flat against the be available to lift
displaced off of the pulmonary and central board and the patient’s legs
abdomen circulation causes maintained in into stirrups. A
vascular congestion alignment to prevent single team
rotation and member should
increased ankle not attempt to lift
pressure the legs alone
If placed supine, a roll Leg holders may
or wedge should be be used to hold
placed under the right patient legs while
flank to decrease prepping or doing
compression on the other activities.
vena cava See image
Graling P, Elariny H. Perioperative Care of the Patient with Morbid Obesity. AORN Journal. 2003;77(4):801–819
4. Kaplan J. Kaplan’s cardiac anesthesia. Philadelphia,

PA: Elsevier Saunders; 2006.
Conclusion 5. Barach P. The impact of the patient safety movement
on clinical care. Adv Anesth. 2003;21:51–80.
Positioning and equipment injuries can occur in 6. Phillips NF, Berry EC, Kohn ML. Berry & Kohn’s oper-
perioperative patients, and it is the responsibility of ating room technique. Louis, MO: St. Mosby; 2007.
7. Primiano M et al. Pressure ulcer prevalence and risk
all perioperative team members to minimize risk to
factors during prolonged surgical procedures. AORN
patients. Surgical positions and equipment pose J. 2011;94(6):555–66.
specific challenges that should be prepared for 8. Nilsson UG. Intraoperative positioning of patients
prior to the procedure. Good team communication under general anesthesia and the risk of postoperative
pain and pressure ulcers. J Perianesth Nurs.
and preparation as well as following safety princi-
2013;28(3):137–43.
ples are key to providing the safest patient care pos- 9. National Pressure Ulcer Advisory Panel. European
sible and to preventing the risk of injury. pressure ulcer advisory panel and pan pacific pressure
injury alliance. Prevention and treatment of pressure
ulcers: quick reference guide. Haesler E, editor. Perth,
WA: Cambridge Media; 2014.
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Challenges in Preventing
Electrical, Thermal, and Radiation 31
Injuries
Mark E. Bruley
“When you have eliminated all which is impossible, then whatever remains, however
improbable, must be the truth.”
—Arthur Conan Doyle
radiation (including light, x-rays, and intense

Introduction MRI magnetic fields)—presents risks of injury if
those risks are not recognized and care not taken
Patients continue to suffer inadvertent skin and to prevent harm.
tissue injuries in the perioperative setting from This chapter addresses the etiologies of intra-
mundane (such as from heated solution bags used operative skin and tissue injuries from medical
for positioning) to highly advance therapeutic and technologies that are the source of electrical,
monitoring technologies (electrosurgery; fluoros- thermal, and radiation energy. A procedure for
copy) that employ electricity, heat, or radiation. investigating such injuries is presented along
This occurs despite a great deal of care and con- with guidance on their prevention. Additional
cern for patient safety by surgeons, anesthesia guidance on incident investigation techniques is
professionals, nurses, and clinical engineering presented in Chaps. 27 and 28.
personnel. Such injuries can prolong morbidity Preventive recommendations that target various
and extend hospitalization, appreciably increas- potentials for patient skin and tissue injury,
ing medical costs to the patient and hospital. The including prevention of surgical fires, are not
healthcare facility and surgical team may also intended as standards, guidelines, or absolute
face associated costs if litigation ensues. requirements. Adoption, modification, or rejec-
Therapeutic and monitoring technologies and tion of the recommendations may be considered
medical devices that employ electricity, heat, or based on clinical assessment of individual patient
radiation present a multitude of hazards that can needs and are not presented with the intent of
injure skin or tissues if adequate attention is not replacing local institutional policies.
paid to their safe use. With these devices various
forms of energy are necessarily applied to surgi-
cal patients in the perioperative setting. Surgical Background
fires on (or in) the patient, although rare, can also
cause potentially devastating tissue injuries. Medical technologies and devices used for peri-
Each type of energy—electricity, heat, and operative treatment or monitoring of patients
have tremendously advanced our practice of sur-
gery since the 1920s with the introduction of the
M.E. Bruley, CCE, BSc (*) first electrosurgical unit (ESU) by William Bovie,
ECRI Institute, 5200 Butler Pike, Plymouth Meeting,
PA 19462, USA MD [1, 2]. In addition to electrosurgical devices,
e-mail: [email protected] there have been advances in other technologies

520 M.E. Bruley
Table 31.1 Technology in which significant advances Keeping the surgical patient safe from periop-
have vastly improved surgical patient care
erative skin and tissue injury caused by electrical,
1. Monitoring (e.g., ECG, capnometry, pulse thermal, or radiation emitting medical technologies
oximetry, nerve monitoring)
is enhanced by surgical team members under-
2. Patient warming and cooling
standing potential etiologies of skin and tissue
3. Surgical drills
injury related to the involved technologies, knowing
4. Lasers
how to investigate such adverse events in order to
5. MR imaging
6. Fluoroscopy
develop and employ measures to prevent some of
7. Fiberoptic light sources.
the more common causes of such injuries.
8. Monitoring (e.g., ECG, capnometry, pulse
oximetry, nerve monitoring)
9. Patient warming and cooling tiologies of Intraoperative Tissue
E
10. Surgical drills Injury
11. Lasers
There are many potential etiologies of accidental
injury to skin and tissues during surgery.
deployed during surgery have vastly improved Intraoperative injuries that are suspected of having
our ability to provide care (see Table 31.1). been caused by a medical device and its related
The discussions of intraoperative tissue injury energy may, however, not be related to a technol-
mechanisms from such electrical, thermal, or ogy. In many cases, the injury may be an abnormal
radiation emitting surgical devices highlight and or idiosyncratic physiologic response to otherwise
point to the types of information that should be normal conditions of device use and performance.
collected and considered during an investigation. Alternatively, the injury may be due to pressure
Historically, the dissemination of innovation in necrosis, tissue chemical sensitivity, an adverse
healthcare has been a slow process [3]. Patient drug reaction, or a disease process that happens to
safety initiatives, as a facet of the process of develop in the area where a device was applied.
healthcare delivery, also suffer from a slow pace The causes and prevention of tissue and nerve
of adoption, especially related to the safe use of injuries related to pressure and patient positioning
medical technologies. For electrical, thermal, or [7–12] are addressed in Chap. 17 in broader detail.
radiation based surgical technologies, the reality In this regard, alternative etiologies beyond those
is that the recommendations for safe application of energy emitting technologies need to be recog-
of the technologies have been in the medical lit- nized and considered to determine the nature of
erature and equipment user manuals, for decades the injury, appropriate treatment, and develop rec-
in many cases, but the understanding and adop- ommendations for preventing recurrence. While
tion of those safe practices by members of the these may appear obvious in particular cases, the
surgical team has lagged [4–6]. Clinical residen- seemingly obvious explanation for a skin injury is
cies serve critical purposes for the surgical team often not the correct one.
members to become proficient in the use of tech- Although certain medical procedures (e.g.,
nology. However, such didactic training rarely electrosurgical procedures) are known to present
stresses the need for users to read the device’s the risk of causing device-related burns or other
user instructions or to understand how the device accidental tissue injuries, it is important to not
functions. This is remarkably different than rush to judgment about the nature or cause of
industry safety standards. Understandably, time such injuries. Over a period of 45 years of inves-
available for medical and nursing training is lim- tigating patient injuries and deaths from errors
ited. However, safety of the surgical patient and accidents involving healthcare technology,
related to the technologies applied to them is instruments, devices, and systems, ECRI Institute
enhanced by clinicians having an understanding has observed that perioperative skin and tissue
of how a device functions along with the associ- injuries are usually much more complex than
ated warnings and precautions. what they seem [4, 13–16]. Table 31.2 lists the
31 Challenges in Preventing Electrical, Thermal, and Radiation Injuries 521
Table 31.2 Etiologies of suspected energy-related perioperative tissue injuries [17]

• Electrical
– Radiofrequency (RF): electrosurgical units (ESUs), RF prostate heating probes, intrauterine ablation probes.
– Direct Current (DC): nerve and muscle stimulators, pacemakers, batteries, ESU circuit continuity monitors
– AC (60 Hz line voltage): OR table, general electro-medical equipment in the OR.
• Thermal
– Direct contact: heating pads, cooling pads, electrocautery, diathermy, heated irrigation solution bag, heated
cotton blanket, powered surgical handpieces (drills, saws) unlubricated, flash-sterilized surgical instruments,
heated prostate or intrauterine probes
– Irradiant: (radiant warmers, exam and operating lights, fiberoptic light cables, lasers, high intensity aiming
lights in mobile X-ray heads)
• Chemical
– Povidone-iodine prep solutions (problems with lot-specific formulations; solution pooled under a patient that
reacts with other solutions or with residual laundry chemicals in linens; mixing with alcohol or hydrogen
peroxide)
– Ethylene oxide (EtO; improper aeration of EtO-sterilized devices)
– Improper electrode (ECG) plating components reacting with conductive paste
• Mechanical
– Constant high pressure in excess of two to three hours (e.g., positioning contours, supports, straps, worn OR
table mattresses pinching); time may be shorter with very high pressure
– Pneumatic tourniquets
– Tenacious electrode adhesive
• Radiation
– Diagnostic imaging
– Therapeutic treatment
• Pharmacologic Adverse Reactions
– Warfarin therapy (e.g., Coumadin)
– Intra-arterial injection of Bicillin (penicillin G)
– Drug infiltration at a catheterization site
– High-dose injected barbiturates injection in subcutaneous or fat layer
• Physiologic/Medical/Disease
– Allergic reaction (e.g., to adhesives, electrode gel, ointment, and skin prep solution)
– Aplasia cutis (neonates)
– Chronic chilblain (pernio)
– Ecthyma gangrenosum
– Disseminated intravascular coagulopathy (DIC)
– Lesions secondary to lupus erythematosus or Hodgkin’s disease
– Lichen sclerosus et atrophicus
– Livedo reticularis
– Livedo reticularis (including idiopathica)
– Purpura fulminans
– Necrotizing fasciitis (“flesh eating bacteria”)
– Ischemic lesions resulting from:
⚬ Peripheral vascular disease
⚬ Venous stasis
⚬ Diabetes mellitus
⚬ Cryoglobulinemia
⚬ Arterial emboli of atherosclerotic plaque (blue-toe syndrome)—iatrogenic, intraoperative, or otherwise
⚬ Anterior-compartment syndrome
522 M.E. Bruley
potential etiologies to consider when presented Investigation Guidelines

with a skin or tissue injury that is suspected of for Perioperative Skin and Tissue
having been caused by a medical technology or Injuries
device. The major etiologies include electrical,
thermal, radiation, chemical, mechanical, phar- When an accidental injury is suspected to have
macologic adverse or allergic reactions, and occurred during surgery, healthcare facilities
physiologic/medical (including diseases). Within typically initiate an investigation to determine
these categories are listed the subordinate mecha- both the nature of the injury and the cause.
nisms of injury and the more common involved While these may appear obvious in particular
devices. cases, the seemingly obvious explanation for a
Medical devices are frequently blamed for skin injury is not always the correct one [17,
perioperative accidental skin and tissue injuries, 24]. The guidelines presented here will help
particularly for those that have the appearance of healthcare personnel organize and conduct a
a full- or partial-thickness burn. However, ther- thorough skin injury investigation to identify
mal or electrical sources are not always involved. the cause of an accidental skin injury. The ques-
It is therefore misleading—and in many cases tionnaire in Appendix 1 facilitates the investiga-
inaccurate—to refer to such an injury as a “burn.” tion process (see page 538).
For these injuries, “lesion” is a more appropriate When approaching the problem of tissue
term because it enables a more deliberate discus- injury, the questions listed in Table 31.3 need to
sion about the consideration of other causes when be addressed in addition to the questions con-
analyzing the root causes of the lesion [18]. tained in Appendix 1.
An understanding of the possible causes and
effects of perioperative skin and tissue injury,
Histology and Etiology combined with an effective investigation proce-
dure, enables investigators to identify the actual
Histologic examination of specimens from the cause of a particular injury and recommend
injured tissue can potentially be revealing as to the precautions, thereby helping to minimize future
type of energy insult that caused the injury, includ- risks to patients and to healthcare facilities.
ing differentiating between an electrosurgical
injury and a thermal injury. Guidance for undertak-
ing histologic analysis has been published specific Table 31.3 Questions to consider when investigating
perioperative skin and tissue injuries suspected of having
to electrosurgical injuries [19, 20] and is available been caused by a medical technology
in a well-known pathology reference text [21]. The
1. What are the various kinds of skin and tissue
pathology and pathogenesis of cutaneous thermal injury, and where in the hospital do they occur?
burns is addressed in the seminal works on the 2. What procedures should be followed immediately
study of thermal injury in humans [22, 23]. after discovery of an injury?
If tissue specimens can be obtained without 3. Who should be involved in an investigation?
stress to the patient, such analysis can go a long 4. What information should be gathered?
way in understanding the root cause of injury, 5. What measures should be implemented to prevent
including the devices truly involved in the cause, future occurrences?
and aid in understanding how to prevent recur- 6. How and when should the hospital communicate
with the manufacturer of implicated devices?
rence. It can also prevent rancorous debate
7. What are the various kinds of skin and tissue
between departmental clinical staff and prevent injury, and where in the hospital do they occur?
legal challenges. Unfortunately, tissue specimens 8. What procedures should be followed immediately
are not typically available for histologic analysis. after discovery of an injury?
Nevertheless, awareness of the ability of histo- 9. Who should be involved in an investigation?
logic examination to assist in differentiating 10. What information should be gathered?
between an electrosurgical insult and a thermal 11. What measures should be implemented to prevent
insult should be part of the investigative approach. future occurrences?
Injury Prevention Incident Report Documentation

and Management: Pre- and Post-
Operative Considerations Completion of an incident report and record of
immediate observations of all involved person-
Perioperative Steps: nel is indicated. To avoid premature or inaccu-
A few routine clinical steps and recorded infor- rate conclusions, the incident report should
mation, listed in Table 31.4, will facilitate the inves- include only facts, not speculation or supposi-
tigation of any skin injury that develops afterward. tion. For example:
• Incorrect: “Patient received electrosurgical

Finding an Injury burns on right buttock and heel.”
• Correct: “Postoperative skin check revealed
If an injury is found or suspected, the steps detailed lesions on the patient’s right buttock and
in Table 31.5 will help in determining the cause: heel.”
Table 31.4 Clinical steps and recorded information that facilitate the investigation
Skin condition Before a procedure, surgical nursing and/or medical personnel should thoroughly examine the
patient’s skin. A description of the general skin condition, as well as any unusual conditions—
rashes, reddened or discolored areas, contusions, cuts, abrasions, or other abnormalities—
should be recorded in the patient history, perioperative record, or surgical notes. Information
obtained during a preoperative skin check will allow staff to identify changes that might have
occurred during or after the procedure
Perform a As soon as possible following a surgical procedure, personnel should examine the patient’s
postoperative skin skin and record any observed changes or abnormalities. In some cases, the patient’s physical
check condition may not permit an immediate and thorough postoperative skin check, but accessible
areas (e.g., buttocks, heels, thighs, elbows, head, electrode sites) should be checked. The
nursing staff should check other areas as soon as possible. Pictures should be taken
immediately and in regular intervals to follow the progressing of the skin injury
Medical The surgical notes for each patient should also include information on the manufacturer, lot
technology numbers, and expiration (or “use before”) dates of prepping solutions, electrodes, and
information electrode gels, as well as information on manufacturers, models, hospital control numbers, and
serial numbers of equipment. However, because it is impractical to expect operating room
personnel to record all this information, the available information should be collected at the
first sign of an injury by the investigative team
Table 31.5 Clinical steps and recorded information that facilitate the investigation
Evidence Preserve and document the evidence. When a suspected device-related lesion is discovered,
preservation personnel should preserve and thoroughly document the evidence, especially all disposables
and packaging. Contaminated disposables or other instruments should be stored in appropriate
biohazard containers
Delayed injury Be aware that injury to internal organs, e.g., bowel, from electrosurgical current may not
onset manifest until several days post-op. Nevertheless, upon discovery, efforts need to be made to
obtain relevant information on the electrosurgical devices and instruments used
Photographs of In collaboration with risk management personnel, and if practical, take color photos of the
injury injury immediately after discovery and 24 and 48 h afterward (permission from the patient or
family may be necessary). Photographs should provide some indication of the scale of the
lesion (e.g., using a coin or ruler)
Medical If possible, surgical and medical personnel should not move or disconnect the equipment,
equipment except as necessary to care for the patient or to prevent further injury or equipment damage.
handling When it is not possible to preserve the physical setup of the involved equipment and devices,
personnel should record the scene with photographs or sketches. Color photographs should be
taken before inspection of devices that may be damaged when examined, such as a disposable
electrosurgical dispersive electrode used with an ESU
Maintaining Ensure that no involved materials or devices are released to the manufacturer or other outside
evidence parties until completion of the internal incident investigation or until approval has been given
possession by risk management or administration
524 M.E. Bruley
Patient and Family Discussion ommend appropriate preventive measures—not

to assign blame. This should be explained to all
Institutional policy will guide the discussion with personnel involved in the incident. To aid the
the patient and family. The discussion with the patient safety process during investigation of a
patient and family about the injury should be hon- perioperative skin or tissue, the questionnaire
est with full disclosure while being cautiously in Appendix 1 can be used by investigators to
diplomatic [17, 25]. The actual cause of the injury collect information during staff interviews and
probably will not be known before the incident is to summarize needed baseline patient and
discussed with the patient and their family. As equipment data.
such, offering specific theories can be misleading
and provoke litigation. For example, if a patient
develops a palm-sized lesion over the sacrum on The Investigation Team
the day following a lengthy cardiovascular surgi-
cal procedure, pressure necrosis is the probable The investigation team should include staff
cause with many potential underlying co-morbidly members who are familiar with the equipment
factors that contributed to the lesion development. used and the environment in which the incident
Unfortunately, in many such cases, the nursing, occurred. The team might include a clinical
medical, or surgical staff has told the patient, engineer, a surgical or critical care nurse, a
“The electrosurgical machine accidentally burned physician, an equipment technician, and the
you during the surgery.” A more productive and risk manager. The risk manager will help
factual approach is to tell the patient that there is ensure that proper steps are taken to preserve
“an injury” or “an area of skin breakdown” and confidentiality and maintain legal compliance.
that it will be treated. In some cases, it may be The chosen coordinator should understand the
suitable to mention that the cause is being investi- various mechanisms of skin injury, the surgical
gated in open and transparent matter [26]. setting, and the investigative process. To ensure
objectivity, no one who had primary responsi-
bility for the patient before or after the injury
omponents of a Thorough
C should be included in the team. Also, the team
Investigation must be careful to fairly represent different
interpretations of the incident: what one person
Skin or tissue injuries sustained—or suspected of calls operator error may be interpreted by
having been sustained—by patients in the operat- someone else as inadequate equipment design
ing room are often initially mistaken for thermal or or a device failure [27].
electrical burns, with medical devices immediately It may be beneficial to deploy qualified,
blamed as the cause. However, such a hasty con- independent external investigators in some
clusion can overlook the actual cause of the injury cases including experts in human factors and
(see Table 31.1 for the list of potential etiologies) accident investigation in the healthcare setting
and delay the implementation of measures to pre- [28]. For example, the hospital may lack the in-
vent future occurrences. Below is a thorough house expertise to investigate the incident; also,
investigation process to help clinical investigators the potential for bias or concealment exists in
uncover the real cause of an accidental skin injury. any in-house investigation. External investiga-
tors can be helpful in exploring both technical
and legal issues, especially when litigation is
The Investigation Process likely. External investigators are usually objec-
tive and cooperative, rather than defensive or
An investigation need not be a threatening adversarial. With in-house investigators, there
experience for anyone. The goal of the investi- may also be the risk of damaging long-term
gation is to determine what happened and rec- working relationships.
Identifying the Cause Table 31.6 Causal factors to consider in the investigation

Device Device failure
When trying to ascertain the cause of any accident factors Design or labeling error
involving healthcare technology, instruments, Manufacturing error
devices, and systems, the investigation should Packaging error
consider the five broad categories listed below Software deficiency
[13, 29]. Within each of these categories are listed Random component failure
the relevant subcategories that may need to be Failure of an accessory
considered when investigating suspected periop- Device interactions
Improper maintenance, testing, repair,
erative device-related skin or tissue injuries or
or lack or failure of pre-use incoming
burns. To ensure thoroughness and accuracy, each inspection
of the factors and issues listed in Table 31.6 must Improper modification
be considered in any investigation. External Power supply failure
It helps to remember that a patient may have factors Medical gas/vacuum systems
specific physiologic sensitivities, abnormali- Electromagnetic or radiofrequency
ties, or diseases. As such, a patient’s suspected interference (EMI or RFI)
“burn” or tissue injury may ultimately be deter- Environmental conditions: temperature,
humidity, light
mined to be an abnormal or idiosyncratic physi-
Water supply (especially temperature)
ologic response to otherwise normal conditions
Tampering/ Family member
of use and performance for that device. It may sabotage Patient
also be determined a technology was not at all
Healthcare worker: doctor, nurse, aide
involved. Enemy
Time is also a significant factor in starting Random act
an investigation. The longer it takes to mount Supplier
and complete an investigation, the greater the Support Poor device evaluation during trial
probability that the cause will grow elusive as system process
evidence is lost, memories dim, defensive failure Lack or failure of incoming and pre-use
rationalizations crystallize, and speculation inspections
clouds the process. Using inappropriate devices
Improper storage
Failure to train and credential
Poor incident/recall reporting system
The Investigation Format
Lack of competent accident
investigation
A thorough investigation of accidental skin injury Failure to sequester incident devices
should include the following: Error in hospital policy
User or use Abuse of the device
• Consideration of the incident report and col- error Accidental misconnections
lected evidence, such as photographs Improper (“bad quality”) connection
• Collection of baseline patient and equipment Device misassembly
information Failure to monitor
• Documentation and assessment of the lesion’s Labeling ignored
appearance and progression Inappropriate reliance on an automated
• Inspection and testing of equipment used feature
• Interviews with involved personnel. Incorrect clinical use
Incorrect control settings
Maintenance or incoming inspection
Before performing equipment inspections and error
interviews the investigation team should review Pre-use inspection not performed
and be familiar with the clinical and surgical
526 M.E. Bruley
p rocedures and conditions surrounding the inci- Table 31.7 Criteria for lesion or skin injury assessment
dent as well as understand the lesion’s clinical Onset When was the lesion discovered? Get
appearance and collect the baseline information. the precise time and date
When did surgery occur?
How long was the patient immobile in
the recovery room or intensive care
Lesion Assessment unit after surgery?
At what time was the last heat therapy
Details about a lesion’s clinical appearance and device or heated product used on the
progression are important to determining its patient and how long was it applied?
cause. A guide for collecting critical informa- Where was discovery made and by
whom?
tion about the lesion can be remembered by the
Progression After discovery, did lesion get larger,
mnemonic OPALSS—Onset, Progression, deeper?
Appearance, Location, Shape, and Size. These Did blister(s) form? When?
six descriptive criteria are central to assessing Did an eschar form?
the cause of a lesion and the potential involve- Appearance What did the lesion look like upon
ment of a medical device. For example, pressure discovery and as it progressed?
necrosis injuries (decubitus ulcers) from intra- Note the color and texture of both the
operative pressure may show up several days central area and the surrounding areas
after the insulting event, whereas electrosurgi- Cation Where was lesion on the body?
cal burns are visible immediately at the end of Record the lesion location in relation
to electrodes, high pressure areas of
surgery and do not suddenly appear days later. contact, positioning devices
The following list illustrates how the OPALSS Is there a clearly definable electrical
criteria can be applied to obtain needed details current path through the area of injury?
about a lesion. The list is not intended to be all- Specify the validity of the alleged
inclusive, but rather to stimulate thinking during electrical current path in collaboration
with engineering staff
the investigation (Table 31.7).
Shape Note the geometry of the lesion
Are there patterns of devices or
electrodes within the lesion?
Baseline Information Does the shape correspond to heat
therapy devices or electrodes?
Baseline information should be collected from Size Measure the injury dimensions
both the patient and the equipment as required What is the area of the injury,
for the investigation. Much of the patient base- including ALL affected tissue area
(e.g., perimeter halos)?
line information will come from the patient’s
If there are multiple lesions, what is
chart. Before conducting any interviews, the the combined area?
patient’s chart should be thoroughly reviewed
because it will indicate the hospital personnel
most appropriate to be interviewed. The investi- Lesion Assessment
gation team should make sure that equipment
information is recorded for all devices involved Characteristics of the lesion itself are frequently
in the incident, including disposables. For the best indicators of its cause. They include the
devices that are routinely inspected, the date of following:
the “last” inspection and the “due” date must be
recorded. If available, equipment inspection, • Time of lesion discovery in relation to the
preventive maintenance, and repair history patient’s surgery or application of a suspect
records should also be reviewed. device (the actual elapsed time is very important).
Lesions from thermal or electrical sources No one who ordinarily maintains suspect
(e.g., ESUs) typically show up right away. equipment should inspect it following an inci-
Lesions due to chemical exposure or pressure dent, as he or she may not recognize past errors
necrosis will take longer to appear, often hours or may even try to conceal them. If alternate
or days after a procedure. technical personnel are not available, an out-
• Shape and dimensions at the time of discovery. side, independent examination of equipment
• Color and texture at discovery. may be most effective. The manufacturer may
• Location on the body and relation to place- want to witness equipment inspections, and it is
ment of suspect devices. usually in everyone’s best interest that this be
• Injury depth estimation upon discovery (i.e., permitted. Inspections are best undertaken by
first, second, or third degree). the hospital’s risk manager and clinical engi-
neer, an outside investigator, and the manufac-
Changes in any of these characteristics should turer simultaneously. Consider videotaping
be noted as the injury progresses. Color photo- these investigations to avoid further confusion
graphs are the best way to document changes in and legal challenges.
the condition of the injury. The time, date, and
scale should be recorded for each photograph.
The use of the same lighting conditions should be sing the Investigation
U
maintained when taking photographs. Questionnaire
The questionnaire in Appendix 1 is a guide for

Equipment Inspection collecting information during interviews, as well
as for summarizing baseline patient data and
After discovery of a suspected device-related skin or recording necessary details about each device
tissue injury, all equipment that may be involved, involved in the investigation [13]. Although it is
including disposables should be sequestered until it designed for skin injuries that occur in the OR,
has been inspected. While rarely possible, due to the the questionnaire may also be used to investigate
need for use of equipment and instruments that were skin injuries that occur in the recovery room and
obviously not involved in an accident, it may also be special care areas or skin injuries noticed on any
helpful to cordon off the operating room or physical patient exposed to heating and illumination
location in which the adverse event happened to devices, tenacious tape or electrode adhesives, or
reduce change of contaminating the accident location prepping and degreasing agents. The completed
and preventing advertent or inadvertent tampering. questionnaire should be filed with the incident
Most equipment can be immediately returned to ser- report and not with the patient’s record. Most
vice because it will be obvious that it played no role information can be recorded directly on the ques-
in the injury. However, no suspect device should be tionnaire form. Lengthy answers to questions and
returned to service until it has been eliminated as a device identification details should be recorded
possible cause of patient injury. on a separate sheet of paper with the numbers
The manufacturer should not be permitted to corresponding to the questions.
remove equipment or disposables from the hospi- The questionnaire is divided into five main
tal because the hospital then loses ready access to sections:
them. The hospital should not send such devices
to their manufacturers or distributors, nor should . Baseline Patient Information
A
vendors be permitted unwitnessed access to the B. Baseline Equipment Information
devices for inspection or repair. In many cases, C. The Surgical Procedure
evidence that might protect the hospital is lost or D. The Injury
compromised. E. The Equipment
528 M.E. Bruley
These sections are discussed below. Additional C. The Surgical Procedure

sections for the interviewer’s and the interview- Patient surgical and medical records typi-
ee’s summary comments are also provided. cally provide information that is only margin-
ally useful in determining the cause of a
device-related injury. The investigation team
Instructions must interview all surgical, medical, and nurs-
ing staff involved in the procedure and post-
• Record the baseline patient and equipment operative care of the patient. It may also be
information (Lists A and B). necessary to question technicians and other
• Make a separate copy of the partially com- personnel responsible for cleaning, sterilizing,
pleted questionnaire for each person who is to inspecting, and maintaining the equipment
be interviewed. and supplies used for the injured patient.
Investigators should pay special attention
Note: Each person involved in the incident should to information concerning any unusual occur-
be interviewed. Relevant questions should be rences during the procedure. For example,
directed to all appropriate people because multiple they should ask about occurrences such as
responses will help corroborate data on the time and those listed in Table 31.8.
sequence of events. Although it is unlikely that any Investigators must also determine how
one person will be able to answer all the questions, solutions, degreasers, and prepping agents
everyone can provide useful information based on were applied during the procedure. During
his or her general observations and discussions with routine surgery, there is usually enough
other personnel involved in the incident. time to apply these substances carefully.
During emergency surgery, however, some-
• Record the interviewee’s answers to all rele- times not enough care is taken and too much
vant questions in Lists C through E. prepping agent is applied. This can result in
pooling beneath the patient. After exposure
Note: Most information can be recorded for several hours to these substances, a sen-
directly on the questionnaire form. If needed, sitive patient may develop skin lesions. A
lengthy answers to questions or device identifica- patient may be sensitive to the prepping
tion details can be recorded on a separate sheet of agent itself, and the application of heat from
paper with the numbers corresponding to the a hyperthermia blanket, for instance, may
questions. Be sure to record the interviewee’s increase that sensitivity. Even the wetness
name and your name on all attached sheets. alone can compromise skin tone and make it
more susceptible to developing pressure
• File the completed questionnaires with the necrosis.
incident report. The questionnaires should not D. The Injury
be filed with the patient’s record. The anatomical drawing on the question-
naire enables interviewers to locate lesions in
A. Baseline Patient Table 31.8 Unusual occurrences to ask about during

The need for baseline information is interviews
self-evident. Changes in device performance
B. Equipment Information Unattended devices
Information about each involved device, Peculiar sounds, monitor displays, smells, or alarms
including disposables, will also be needed for Sudden changes in the patient’s condition or physical
a thorough investigation to be conducted. position
relation to the incision site, dispersive elec- radiation emitting surgical devices used dur-
trosurgical electrodes (“grounding pads”), ing surgery. These technology-specific discus-
stimulation electrodes, ECG electrodes, and sions will aid in determining whether the
all associated cables. Any contact between suspect device truly caused the patient injury.
the patient and metal (e.g., drape supports on
the side of the operating table, mechanical
supporting instruments such as retractors) lectrosurgical and Electrocautery
E
should also be recorded. Technology
Lesion patterns can help identify the
causes. When an ESU is used, incomplete lectrosurgery vs. Electrocautery:
E
contact of an electrosurgical dispersive elec- Untangling the Terminology
trode with the patient may produce a lesion
identical to a section of the electrode’s Electrosurgery and electrocautery are similar in
perimeter. Or when a hypo/hyperthermia that both apply electric current for therapeutic
blanket is used, lesions that conform to the purposes, but they are distinct technologies with
blanket’s ridges or internal connectors may some fundamental differences. The most signifi-
appear on the sacral areas, while no other cant of these is that electrosurgery incorporates
area of the skin that was touching the blan- the patient as part of the electrical circuit, whereas
ket shows any injury. In such a case, the electrocautery does not. Although staff may
blanket was probably not hot enough to sometimes use the terms “electrosurgery” and
cause thermal injury from simple contact. “electrocautery” interchangeably, the terms are
As such a possible cause to consider is pres- not synonymous, and the distinction between the
sure necrosis (perhaps in combination with two is important. For example, the use of the
mild heat). incorrect term can hinder efforts to investigate
The investigation team should pay atten- and address adverse surgical incidents.
tion to when the injury was discovered and Both technologies are inherently hazard-
any subsequent changes. While a lesion on ous—they are intended to cut, coagulate, or
the patient’s back or sacral area may have destroy human tissue and can do so not only at
been discovered several hours postopera- the target operative site, but also in alternate
tively in the recovery room or intensive care sites if care is not taken during equipment and
area, it may have actually occurred in the OR, accessory setup and use. However, electrosurgi-
but was aggravated by the patient’s position cal units are much more likely than electrocau-
during postoperative care. The patient’s treat- tery to cause injuries based on the physics of the
ment and medication and other comments technology [13, 30–38].
regarding the progression and prognosis of Electrosurgery is used for a wide variety of
the lesion should also be recorded. applications, from removing skin lesions to per-
As previously mentioned, determining forming thoracic, abdominal, orthopedic, and
the etiology of an injury may be aided by brain surgery. The technology concentrates a
histological examination of skin or tissue high-density, radiofrequency electric current at
pathology specimens [16, 19, 20]. Such the tip of an active electrode, enabling the active
specimens may have been taken during electrode to cut and/or coagulate tissue [39]. The
debridement. Pathology findings may be therapeutic current for electrosurgery is generated
able to reveal whether the injury was caused by an ESU and then conducted through a com-
by a disease, electrosurgical current, or ther- pleted electrical circuit that comprises the follow-
mal injury. ing: the ESU itself, insulated cables, an active
E. The Equipment electrode (which delivers the electrosurgical cur-
Following are discussions specific to the injury rent to the target tissue), the patient, and one or
mechanisms from electrical, thermal, and more dispersive return electrodes (which collect
530 M.E. Bruley
the current from the patient and return it to the open-circuit activation), a properly operating
ESU). The dispersive return electrode is fre- isolated-output unit could cause an alternate-site
quently called by the colloquial term of “ground- burn from current originating at the return elec-
ing pad,” although they are no longer grounded trode. Alternate-site burns have been reported
with modern ESUs. Thus, the current generated with the use of needle electrodes used for EEG or
by the ESU passes through the patient’s body. ECG monitoring and at the site of an esophageal
ESUs operate only on AC line power. temperature probe [40, 41]. The current pathway
Electrocautery is typically used for minor sur- for alternate-site burns can be complicated to
gical procedures in dermatology, ophthalmology, determine: outside assistance is frequently
and gynecology. The technology uses electric needed in reviewing such cases.
current to heat a high-resistance wire or scalpel Poor electrical continuity in either the return
blade at the tip of the electrode. However, unlike electrode or cables usually results in a request by
with electrosurgery, the technology does not pass the surgeon for more power (higher dial settings)
current through the patient’s body. Electrocautery because the desired surgical effect is not achieved.
units, which are available in reusable or dispos- However, increasing the power setting under con-
able versions, can operate either with DC (i.e., ditions of poor continuity usually does not result
battery) or AC line power. in the expected increase in ESU performance,
and the surgeon may again request more power.
Staff education and the use of a return electrode
Electrosurgical Units (ESUs) contact-quality monitor can minimize the risk of
and Accessories: Overview injury from a partially detached return electrode.
If a lesion is found beneath the electrosurgical
Information obtained from interviews about the dispersive electrode, surgical personnel should
performance and control settings of the ESU, its inspect the electrode immediately for discoloration,
electrodes, and cables should be compared with obvious damage, wetness of the gel, evidence of
the results from equipment inspections. If the ESU contact with fluids, and those other characteristics
unit itself meets proper performance specifications listed in the questionnaire. Comparison with a new
(e.g., the manufacturer’s), it can be returned to ser- electrode is helpful in determining subtle differ-
vice. In most cases of skin injury involving ESUs, ences in the suspect electrode. The investigator
the cause of the injury is related to the electrodes, should also observe whether the entire conductive
cables, or other accessories, rather than improper or capacitively coupled surface had been in contact
functioning of the unit itself. Insufficient contact, with the patient’s skin. It should also be noted
improper electrode placement or size, an inade- whether straps were placed over the electrode or
quate amount of gel, pressure on the pad, or a whether a member of the surgical team leaned on it
defective electrode can contribute to lesions or stepped on its cable and caused partial dislodg-
beneath the dispersive electrode. Defective cables ment. Pressure on a disposable return electrode or
and connectors may cause electrosurgical currents partial dislodgment may cause localized high cur-
to seek alternate return pathways through the rent densities, which can cause burns. Later inspec-
patient, resulting in injuries at locations other than tions should be performed to determine if there are
the incision or return electrode sites. any discontinuities or separations of the connector
The type of ESU can be a factor in the cause and/or of the conductive substrate (usually made of
of alternate-site burns. Typically, ground- foil) or whether a part of the electrode is missing.
referenced ESUs will more likely be associated Hand-switched active electrodes (“pencils”),
with an alternate-site burn than isolated-output both disposable and reusable, must also be
units, although very few units of such design are inspected. A defective switching mechanism of a
in use in North America. However, the investiga- hand-switched active electrode can cause inad-
tor should be aware that isolation can fail and vertent activation of the ESU and result in burns.
that, under certain operating conditions (e.g., Insulation failure can also cause a burn where the
section of the electrode with missing or poor the use of energy emitting medical devices the
insulation contacted the patient. Determining Society of American Gastrointestinal and
where the active electrode was placed between Endoscopic Surgeons (SAGES) has created an
uses is essential to discover the mechanism of educational initiative called the Fundamental
injury. Injury from inadvertent activation would Use of Surgical Energy (FUSE) program (www.
be more likely if the electrode was not placed in fuseprogram.org) [52]. The FUSE program was
a well-insulated safety holster. established to ensure that surgeons and others in
Burns at the dispersive return electrode site the perioperative setting who handle energy-
have historically been related to due to poor elec- based devices have a more comprehensive
trode site preparation or pad dislodgement [33, understanding of how to use them safely. It
42, 43]. More recently, the increased use of elec- focuses on providing education about devices
trosurgical devices and techniques that apply that apply energy to tissues in many different
high currents to the patient for long periods of ways, including electric current at radiofre-
time has led to an increased risk of skin burns at quency wavelength (e.g., electrosurgery), ultra-
the return-electrode site [44–47]. To protect sonic energy, and microwave- based, water
patients, clinicians and other personnel need to jet-based, and plasma-based energy. The pro-
be alert to the situations that are most likely to gram is designed to certify that successful candi-
lead to such injuries during surgical procedures date licensed physicians, nurses, and surgical
that may demand greater activation times of the technicians have demonstrated knowledge fun-
ESU. Patient injuries have resulted from damage damental to the safe use of surgical energy-based
to active electrosurgical instruments and chords devices in the operating room, endoscopic suite,
[43] as well as from performance or design limi- and other procedural areas.
tations of specific makes and models of electro- The FUSE program attempts to bridge a gap
surgical active electrodes [48–50]. in patient safety as it relates to best practice in the
Misconnecting a bipolar electrosurgical for- use of surgical and endoscopic energy devices by
ceps to the monopolar sockets has caused inad- addressing the most common types of energy
vertent activation of the ESU and burns to emitting devices, their impact on surgical fire
non-target tissues [51]. The plugs for many third- prevention, the safety of implantable electronic
party bipolar forceps can be readily plugged into devices, and safe use of such devices within the
the monopolar sockets. More recently, dedicated operative field.
molded plug designs on bipolar electrodes pre-
vent such misconnection.
erve Monitoring Units
N
and Electrosurgery
he Clinical Knowledge Base
T
About Electrosurgery Burns from electrosurgical current interacting
with nerve monitoring equipment may result in
Surgeons are typically expert users of electro- skin or tissue injuries. Needle electrodes used with
surgical technologies, but may have much less such monitors have a very small surface area and,
understanding about how it actually works, how therefore, a potentially high current concentration
it can cause accidental skin or internal organ if electrosurgical current passes through them.
injury, or how to investigate an injury suspected One manufacturer, Medtronic, provides the warn-
of having been caused by electrosurgery. ings on their website to prevent such injuries [8].
Recently published research has shown that sur- For example, warnings for the Medtronic NIM 3.0
geons, regardless of their years of experience, nerve monitor the websites state that:
have knowledge gaps regarding the safe use and “To avoid patient burns:
effective use of electrosurgical technology [6,
52]. Of note in the attempts to address the knowl- • Do not activate the electrosurgical instruments
edge gaps related to surgical patient safety and while stimulator is in contact with tissue.
532 M.E. Bruley
• Do not leave stimulating electrodes or probes sive should not be folded over on themselves.
in surgical field. Rather, they should be applied to a nonstick
• Do not store stimulating electrodes or probes material, such as the backing material with which
in electrosurgical instrument holder. the electrode was packaged. If necessary, a new
• Do not allow a second surgeon to use electro- electrode can be opened and its nonstick backing
surgical instruments while stimulator is in use.” can be applied to the suspect electrode. Doing so
will help prevent the electrode from drying out
and makes subsequent testing easier and more
Direct Current Injury likely to produce useful results.
Low voltage (3–14 V) of direct current (DC) can

cause surprisingly serious lesions to the patient if Endoscopes and Laparoscopes
the offending current is in contact with the skin or
tissue for sufficient time [53]. An application of Endoscopes, laparoscopes and their accessories,
DC to the tissues results in an electrochemical trocars and sleeves are frequently used in combina-
lesion due to electrolysis. The errant DC may tion with electrosurgery and have the potential to
come from overly aggressive application of the be a pathway for stray electrosurgical currents to
therapeutic current levels, a device malfunction, cause injury to internal organs [34, 44, 60, 61]. The
or from interaction with another technology. investigation team should be familiar with the
Nerve stimulators/locators and nerve monitors, as basics of the safe use of laparoscopes and their
well as at least one pacemaker, have been associ- instruments, as well as any special connectors that
ated with such lesions [54–58]. The investigation are required, before investigating an incident in
of a suspected DC lesion must consider interac- which these devices were involved. Errors made in
tions between the suspect DC device and electro- the setup and operation of endoscopes and their
surgical equipment. Testing to determine if a accessories may not be evident when the equip-
device is performing according to specification is ment is examined later. However, deficiencies in
typically insufficient to assess the potential their insulation may be revealed during an inspec-
involvement of a device in the cause of an injury. tion. Endoscopes are exposed to repeated steriliza-
Pulse oximeters have been reported to cause a tion by steam or EtO or by cold sterilizing or
DC burn due to exposed conductors in the sensor disinfecting chemicals. This exposure can result in
[59]. Disposable adhesive oximeter sensors are insulation breakdown on the active electrode or on
potentially more prone to damage during use such components of the endoscope itself. If this type of
that the conductors can become exposed. The con- deterioration is observed, the possibility of alter-
ductors carry DC and contact the skin directly. The nate electrosurgical current pathways as a cause of
long duration of application of pulse oximeter the injury should be considered. Under certain con-
probes on the patient sensing site (e.g., finger, ear ditions, internal burns can occur without observ-
lobe, foot, toe) can result in an electrochemical DC able damage to insulation. The risks of patient
burn despite the low DC current levels present. injury resulting from capacitive coupling of elec-
trosurgical energy to endoscopic accessories should
be thoroughly understood by the investigators.
Handling Electrodes
During Investigations
Thermal Injuries
Care should be taken when handling electrodes
(e.g., electrosurgical, nerve stimulation, and EEG Experimental research into the temperature and
electrodes) used during a procedure in which an duration of application of heat to cause cutaneous
injury may have been sustained. Suspect elec- burns in humans from contact or a radiant heat
trodes with adhesive borders or conductive adhe- source has been published in only a few studies
[22, 23, 62–65]. Since human physiology and the Hypothermia Pads
pathophysiology of burned skin has not changed, Cooling patients during surgery to slow body and
these seminal studies remain valid for assessing the especially brain metabolism, such as during sur-
time and temperature required to cause a thermal geries involving cardiopulmonary bypass, involves
injury from contact with a hot object or heating withdrawing energy from the patient. If the inves-
from an irradiant source. Investigators of a periop- tigation of a postoperative skin lesion on a patient’s
erative injury suspected of being thermal in origin back, for example, finds that the machine is per-
are directed to these references to gain a functional forming to specification, systemic physiologic
understanding of the time and temperature rela- conditions or diseases need to be considered as the
tionships that may impact on determining whether cause, but as they may be related to the cool tem-
a specific surgical device may have been hot peratures applied to the skin. An initial perspective
enough for long enough to cause a thermal injury. may be that the patient suffered frostbite, which
occurs from freezing of the skin. However, human
skin does not freeze until at least 30.7 °F
Hypo/Hyperthermia Units (−0.53 °C), which is below the freezing point of
water at 32 °F (0 °C) [67]. Further, the hypother-
Hyperthermia Pads mia cooling pads cannot deliver water at that
In most cases of intraoperative skin injury attrib- freezing temperature: they operate by circulating
uted to hyperthermia warming blankets, the unit chilled water through a blanket at a temperature of
proves to be operating properly: other causative approximately 36 °F (3 °C). Nevertheless, at the
mechanisms must then be considered (e.g., pres- temperatures around 36 °F (3 °C), skin lesions can
sure necrosis) or misuse [17, 24, 66]. With both occur from condition of cryoglobulinemia [17,
of these devices, it is important to inspect the 24]—a reaction to systemic infections that released
units in all possible operating modes, both with cryolobulin into the blood stream—wherein the
and without the actual temperature probe used on cold compromises venous blood flow by solidify-
the patient plugged into the machine. Primary ing the cryolobulin at leading to venous stasis
and redundant thermostat failure, misadjustment, lesions. Cryoglobulin precipitates at 50 °F (10 °C).
or faulty calibration may not be discovered Similarly, patients with pernio [17, 24], an inflam-
except under very specific, abnormal operating matory skin condition presenting after exposure to
conditions. cold that can lead to skin lesions, may present
In addition to general information on the use postoperatively with lesions that mirror the geom-
of the equipment, the investigation team should etry of the cooling pad.
review cleaning and sterilization procedures for
the hypo/hyperthermia blanket if it was reusable. orced Air Hyperthermia Blankets
F
Latent cleaning and disinfecting chemicals may Patient burns have occurred from use of forced
be the cause of what appears to be a thermal burn. air warming blanket systems [68–70]. Although
Also reviewed should be the placement of the these systems are intended for surgical use, incor-
temperature probe on the patient. Manipulation rect use can cause the heated air delivered to the
or repositioning of the patient after insertion or table and the blanket to be inadequately distrib-
placement of the temperature probe (rectal, uted resulting in localized heating to the extent of
esophageal, or skin) can dislodge the probe. causing burns to the surgical patient. Specifically,
Depending on the operating mode, this may using the units by placing the hose under the sur-
cause a hypo/hyperthermia unit to heat even gical drapes without using the associated air dis-
though it was set to cool the patient. tribution blanket can cause injury [68].
534 M.E. Bruley
Phacoemulsifiers Table 31.9 Surgical technologies that have caused ther-

mal burns during surgery
Scleral and corneal burns have been reported dur- High intensity surgical light sources, including
fiberoptics [75–80]
ing phacoemulsification—a delicate and com-
Hot surgical instruments due to flash sterilization [62,
plex surgical ophthalmic procedure performed to 81–83]
remove cataracts. During extended use of the Laryngoscope bulbs [84] or heating from battery
probe, the rapid oscillation of the ultrasonic failure [84]
probe tip and the friction generated can cause Overhead surgical lights [85]
excessive heating. The thermal injuries can occur Infant radiant warmers [86]
at the location where the probe entered the eye Surgical drills [87, 88]
and are caused by overheating of the probe tip. Surgical microscopes [79]
Such injuries are less common today, but the Transilluminators [89, 90]
potential is still present. The cause of the heating Bags of solution or irrigation fluids from solution
warming cabinets [91–94]
is multifaceted, relating primarily to insufficient
Blankets from blanket warming cabinets [92–95].
irrigation and aspiration flow, the use of more
aggressive techniques, and the use of smaller Of these, infant radiant warmers and warming cabinets are
discussed in greater detail below
incisions and smaller diameter probe tips [71].
Radiant Warmers
Pulse Oximeters
Surgery on neonates is being performed more
Thermal burns and other skin injuries have been frequently in the neonatal intensive care unit with
associated with the use of pulse oximeters, which the patient in the infant radiant warmer bassinet.
are used during most surgical procedures (i.e., These procedures include, among others, repair
during electrosurgery) [59, 72]. Pulse oximeter of patent ductus arteriosus and pyloric stenosis,
probes have provided alternate path—ways for and virtually all of which involve the use of elec-
electrosurgical currents. Also, skin injuries have trosurgery. Neonatal skin is highly vulnerable to
occurred at pulse oximeter probe sites from pres- heat and a postoperative skin lesion on a neonate
sure necrosis, and mismatching of pulse oximeter may be suspected of having been caused by the
probes and monitors has resulted in excessive ESU or the radiant warmer. Lesions resulting
heating of the probe LEDs. Burns involving the from exposure to radiant warmers are commonly
leads from pulse oximeters have also occurred caused by operator error, device malfunction, or
during MRI procedures [72–74]. If pulse oxime- poor device design [86]. As with hyperthermia
ter involvement is suspected, carefully inspect pads, a dislodged probe on a radiant warmer can
the probe and its cabling, note the location of the cause it to constantly heat, even if it was set to
probe and how the cable was draped, and note cycle on and off. Differentiating between ESU
whether the probe site was changed during the versus radiant heat as the cause of the injury
procedure. Because pulse oximeter and probe especially requires defining the onset, progres-
compatibility is a potential cause of injury, note sion, appearance, location, shape, and size of the
whether the probe was used with the appropriate lesion as described earlier.
pulse oximeter monitor and compatible cable.
lanket and Solution Warming

B
Irradiant and Other Heat Sources Cabinets
A variety of surgical technologies have resulted Burns have occurred to surgical patients from
in perioperative thermal burn injuries, including overheated blankets removed from warming cab-
those listed in Table 31.9. inets set to excessive temperatures, as well from
heated solution bags used as positioning aids. in addition to reviewing the citations provided.
The ECRI Institute recommends that temperature Many of these lesions appear similar to conven-
settings on blanket warming cabinets be limited tional radiation injuries and require expert sup-
to 130 °F (54 °C) and that solution warming cabi- port to manage the acute and potentially lasting
nets be limited to 110 °F [92–95]. Warming cabi- injuries to tissue [98].
nets are used to heat blankets and solutions (e.g.,
for surgical irrigation and intravenous infusions)
for patient comfort. Warmed blankets are often MR Imaging
placed on patients to make them feel more com-
fortable in cool ambient temperatures or when Patient burns during MR imaging, along with
sedation or anesthesia has disturbed the body’s recommendations for preventing them, have been
thermal regulation. Warmed solutions are used to reported for many years [72–74, 99–104].
prevent hypothermia caused by infusion of lower- Perioperative MR imaging is a growing field.
temperature liquids into a patient’s body. Most Although burns in this setting have yet to be
warming cabinets have separate compartments reported, investigators should be cognizant of the
and temperature settings for blankets and solu- possibility.
tions. In response to customer demands, suppli-
ers have designed some cabinets so that they can
be set to a wide range of temperatures. Thermal Injury from Surgical Fires
Unfortunately, this allows the cabinets to heat
blankets and solutions to temperatures that can The risk of a fire on or within a surgical patient
cause contact burns to patients’ skin. continues to be present in modern surgery [5,
Surgical patients have received burns during 10, 14, 75, 78, 105–129]. Surgical fires were
surgery because warmed blankets or solutions ranked among the top ten health technology
were too hot. Such thermal injuries typically hazards from 2007–2012 by the ECRI Institute
occur with patients who are unconscious or who [130–136]. Fires can result in severely disfigur-
have been given regional (e.g., spinal) anesthesia ing or fatal skin, tissue, or lung injuries—and
and are therefore insensate to temperature. Most take an emotional toll on surgical team mem-
incidents have involved solution containers (e.g., bers. The current recommendations in the peri-
IV bags) that have been heated to unsafe tempera- operative setting make virtually all surgical
tures and then used inappropriately as positioning fires preventable. Unfortunately, the sensitivity
aids during surgery or as “hot water bottles” to of surgical, anesthesia, and operating room
provide local heat. In other incidents, overheated (OR) nursing staff members to these fire haz-
solutions have been used for surgical irrigation, ards has waned since the cessation of the use of
causing severe internal injury. Also, blankets that flammable anesthetic agents in the late 1970s
have been excessively heated and placed on or [5, 11, 20, 118, 137]. It is encouraging, how-
under the patient have caused burns; in some ever, that during the last ten years, the surgical,
cases, the blankets were folded in layers. anesthesia, and nursing communities have
experienced the beginnings of a resurgence in
the awareness of this continuing risk as well as
Fluoroscopy an understanding of the need for a surgical team
approach to the prevention of surgical fires.
The use of interventional radiological imaging Preventive measures to minimize the risk of a
has been reported to cause radiation burns [20, surgical fire have existed for decades, but only
96, 97]. Investigators of suspected perioperative in recent years have they begun to diffuse
radiation burns are advised to seek assistance in across professional boundaries and to be put
their inquires from medical radiation physicists, into wider practice.
536 M.E. Bruley
Aiding in this diffusion have been initiatives fires per year in the USA, but it cites the
by a variety of medical professional societies and Pennsylvania data as being the most accurate
health care organizations including the American estimate of the incidence of surgical fires cur-
College of Surgeons [10, 105], the American rently available. About 70 % of surgical fires
Society of Anesthesiologists [10, 135], the involve electrosurgical equipment as the igni-
Anesthesia Patient Safety Foundation [10, 138], tion source with another 10 % involving surgi-
the Association of periOperative Registered cal lasers [75]. A variety of other ignition
Nurses [9, 108, 125, 128, 129, 135, 139, 140], the sources account for the remainder of fires,
Pennsylvania Patient Safety Authority [120– including:
122], and The Joint Commission [110, 127]
which now hosts the surgical fire prevention and • Electrocautery (hot wire cauterization), either
education Internet resources compiled by the US battery operated or line powered
Food and Drug Administration (FDA) between • Fiberoptic light sources
2011 and June 2015. • High-speed burs (which can produce sparks),
Fire requires three things: The principal con- but only if an oxygen-enriched atmosphere is
tributing factor to surgical fires has historically present.
been the use of open oxygen supplied at 100 %
concentration from an anesthesia machine or Most laser ignited fires occur during tracheal or
wall oxygen outlet to a disposable mask or nasal bronchoscopic surgery where the beam or laser
cannula on the face during surgery of the head, fiber is in extremely close proximity to the endo-
neck, and upper chest with monitored anesthesia tracheal tube or bronchoscope when fired [123,
care [4, 10, 14, 24, 75, 108, 137, 139]. Oxygen- 124]. Laser safe, ignition resistant endotracheal
enriched atmospheres account for approximately tubes are available, but must be selected specifi-
70 % of surgical fires [75, 114] with oxygen cally for the wavelength of the laser being used.
enrichment as a major contributing factor to sur- However, the bronchoscopes are not protected
gical fires [105, 119, 126, 141]. Administration against ignition—if the laser is fired while inside
of supplemental oxygen has typically been per- the scope or if the energy strikes the outside of the
formed without consideration of the true need of scope it can ignite, especially if there is oxygen
the patient for such a high concentration. enrichment present in the pulmonary tree.
Enrichment of the facial hair, including the fine Over the past decade, refined recommended
vellus hair on the face, nose, cheeks, and fore- techniques for prevention of surgical fires have
head of both men and women, and of the surgical been begun to change practice and are freely
towels and drapes results in an easily ignitable available on the Internet, including posters, and
condition. Alcohol-based surgical skin prep have videos [10, 75, 107, 120, 138]. Appendix 2
had a resurgence in use over the past 20 years reproduces the free posters from ECRI Institute
and have also contributed to the incidence of sur- that summarize the still current recommenda-
gical fires [75, 114, 122, 142, 143]. tions for minimizing the potential for a surgical
The estimated number of surgical fires has fire and for extinguishing a surgical fire burning
ranged from 550 to 650 per year in 2007 [75, on or in a patient [144–146].
139] to a more recent estimate incidence of The key points promoted in these initiatives
200–240 [113] based on this chapter’s author’s include a major change in the recommenda-
scaling of newer data from the Pennsylvania tions regarding the control of oxygen delivery
Patient Safety Authority [109] to the US popu- during surgery of the head, face, neck, and
lation. ECRI receives reports from healthcare upper chest [10, 75, 107, 138]. This recom-
institutions and other sources on about 100 mendation, with certain limited exceptions, is
that the traditional practice of open delivery of injury will help ensure effective determination
100 % oxygen should be discontinued for these of the etiology of the injury, appropriate treat-
surgeries. If supplemental oxygen is needed to ment, and help develop preventive
maintain the patient’s blood oxygen saturation, recommendations.
the airway should be secured through intuba- Perioperative injuries that are suspected of
tion or the use of a laryngeal mask airway to having been caused by a medical device and
prevent oxygen-enriched gases from venting its related energy may not be related to a tech-
under the surgical drapes. The need to assess nology: consideration of all possible device
the range of human factors [147] that contrib- and/or solution interactions is essential. In
ute to surgical fire risks as a component of the many cases, the injury may be an abnormal or
preoperative “time-out” is an innovative addi- idiosyncratic physiologic response to other-
tion to the present standard [10, 75, 109, 138]. wise normal conditions of device use and
Tools for assessing the surgical fire risks dur- performance.
ing the “time-out” were first published in 2006 While it is easy to assume that a certain
[148] and are available at www.christianacare. medical device caused the injury simply
org/FireRiskAssessment. because it was used, such assumptions are
often incorrect and may preclude consider-
ations of other possibilities. Hasty conclusions
Summary that a device or operator was at fault may bias
the investigation, cause ineffective treatment
The hazard of electrical, thermal (including of the injury, delay development of effective
surgical fires), and radiation related periopera- preventive recommendations, mislead the
tive skin and tissue injuries to patients continue patient into bringing suit, and unjustly impugn
to present risks of injury to patients. Care must personnel, equipment, service organizations,
be taken by clinical staff to understand the or manufacturers.
mechanisms of potential injury from the Development of effective preventive recom-
healthcare technologies they use in surgery, mendations is promoted and surgical patient
including understanding the warnings and pre- safety enhanced when all possibilities of an
cautions presented in the user manuals. injury are explored and everyone involved in
Following careful forensic guidelines for con- the incident has provided input to the
ducting an effective investigation of a patient investigation.
538 M.E. Bruley
ppendix 1: Questionnaire for Investigating Accidental Perioperative Skin or

A
Tissue Injury [51]
Accidental Skin Injury

Investigation Questionnaire
Date of Interview: _______________________________________________________________________
Interviewee:
Name ____________________________________________________________________________________
Title/department ____________________________________________________________________________
Job function during incident __________________________________________________________________
Interviewer:
Name ____________________________________________________________________________________
Department________________________________________________________________________________
A. Baseline Patient Information

1. Name __________________________________________________________________________________
2. Hospital ID No. __________________________________________________________________________
3. Sex ____________________________________________________________________________________
4. Age ____________________________________
5. Race ___________________________________ Instructions
6. Skin color and skin description (e.g., mottled)

Record the baseline patient information (Section A) and
__________________________________________ baseline equipment information (Section B). Note that Sec-
tion B will need to be completed for each involved device,
__________________________________________ including disposables; thus, it may be necessary to make
multiple copies of that page.
__________________________________________
Make a separate copy of the partially completed question-
naire for each person who is to be interviewed.
7. Weight _________________________________
Record the answers to all relevant questions in the remain-
ing sections. Attach additional sheets, if needed; be sure to
8. Diagnosis _______________________________
record the interviewee’s name and your name on all at-
__________________________________________ tached sheets.
__________________________________________ File the completed questionnaires with the incident report.

The questionnaires should not be filed with the patient’s
record.
9. Known allergies __________________________
__________________________________________
Source. This form was developed by ECRI. A detailed dis-
10. Known circulatory problems _______________ cussion of how to use this questionnaire is included in the
December 2005 issue of ECRI’s monthly journal Health
__________________________________________ Devices.
B. Baseline Equipment Information

Copy this page and record the following information for each involved device (including disposables). Attach all
completed copies to the questionnaire.
1. Device type __________________________ 1. Device type __________________________

2. Manufacturer _________________________ 2. Manufacturer _________________________
3. Model ______________________________ 3. Model ______________________________
4. Serial and/or Lot No.___________________ 4. Serial and/or Lot No.___________________
5. Hospital Equipment Control No.__________ 5. Hospital Equipment Control No.__________
6. Expiration date or “use before” date _______ 6. Expiration date or “use before” date _______
____________________________________ ____________________________________
7. “Last” and “due” inspection dates_________ 7. “Last” and “due” inspection dates_________
____________________________________ ____________________________________
8. Any outstanding recalls or Action Items 8. Any outstanding recalls or Action Items
regarding this device* __________________ regarding this device* __________________
____________________________________ ____________________________________
9. If reusable, method of sterilization or 9. If reusable, method of sterilization or
cleaning _____________________________ cleaning _____________________________
10. For endoscopes and endoscopic instruments, 10. For endoscopes and endoscopic instruments,
also record the following: also record the following:
a. Generic type (e.g., laparoscope or a. Generic type (e.g., laparoscope or
laparoscopic forceps, resectoscope, laparoscopic forceps, resectoscope,
colonoscope) _______________________ colonoscope) _______________________
b. Endoscope type b. Endoscope type
i. Operating or diagnostic (circle one) i. Operating or diagnostic (circle one)
ii. Direct viewing or video (circle one ii. Direct viewing or video (circle one
or both) or both)
c. Trocar sleeve type—metal, plastic, c. Trocar sleeve type—metal, plastic,
other______________________________ other______________________________
__________________________________ __________________________________
d. Light source and fiberoptic cable d. Light source and fiberoptic cable
used ______________________________ used ______________________________
__________________________________ __________________________________
e. Special connectors or e. Special connectors or
adapters ___________________________ adapters ___________________________
__________________________________ __________________________________
540 M.E. Bruley
C. The Surgical Procedure

1. Procedure ________________________________________________________________________________
2. Date performed and OR No. _________________________________________________________________
3. Time duration _____________________________________________________________________________
4. How many procedures of this type are performed per month? _______________________________________
5. Was this an elective or emergency procedure? ___________________________________________________

________________________________________________________________________________________
6. Who was present during the procedure? ________________________________________________________

________________________________________________________________________________________
7. Who performed the following tasks? When?
a. Applied degreasing and prepping agents _____________________________________________________
b. Applied ESU dispersive electrode ___________________________________________________________
c. Applied surgical drapes ___________________________________________________________________
d. Inserted hypo/hyperthermia temperature probe ________________________________________________
e. Set up ESU and connected cables ___________________________________________________________
f. Set up endoscope and accessories ___________________________________________________________
g. Applied any other electrodes, temperature probes, etc. __________________________________________
8. Was a skin check performed before the procedure? By whom? Results? _______________________________
________________________________________________________________________________________
9. Was the patient wearing jewelry or any other items during the procedure? _____________________________
10. What degreasers, prepping agents, and ointments were used?________________________________________

________________________________________________________________________________________
11. How were they applied to the patient? Were they poured onto the skin? _______________________________
________________________________________________________________________________________
12. Was there pooling of fluids beneath the patient? __________________________________________________
13. Were prepping agents dry before draping? ______________________________________________________
14. What was the patient’s initial position on the operating table? For how long? ___________________________
________________________________________________________________________________________
15. In what position(s) was the patient placed for surgery? For recovery? _________________________________
________________________________________________________________________________________
16. Were any changes made in the patient’s position during surgery? Describe. ____________________________
________________________________________________________________________________________
17. What types of restraint straps or positioning pads were used to position the patient?
Describe their location. _____________________________________________________________________
________________________________________________________________________________________
18. What, if anything, occurred during the procedure that was out of the ordinary? Any alarms or unusual noises?
________________________________________________________________________________________
________________________________________________________________________________________
19. How well does the user understand the equipment controls, functions, and safety features? ________________
________________________________________________________________________________________
D. The Injury
1. Mark on the anatomical drawing the position and shape of the following items:
a. Skin injuries
b. ESU dispersive electrode
c. ECG electrodes and cables
d. Extent of prepping
e. Incision (or site of active electrode)
f. Restraint straps
g. Patient/metal contacts
h. Conductive masks and tubing
2. When and where was the lesion noticed

(e.g., during surgery, postop, or recov-
ery; in the patient’s room)?
By whom? ______________________
_______________________________
_______________________________
_______________________________
3. Did the lesion correspond to the position

of an electrode, a cable, or patient/metal
contacts? ________________________
_______________________________
4. Does the patient have any metal implants (e.g., hip, knee)? __________________________________________
5. Sketch the shape of the lesion in the space provided.

542 M.E. Bruley
6. Give the dimensions. _______________________________________________________________________
7. Extent: Full or partial thickness? First degree? Second? Third? ______________________________________
8. Describe lesion tissue color, texture, size, and location when first noticed
and as healing progressed. ___________________________________________________________________
________________________________________________________________________________________
9. Were photographs taken? Record the dates and times, and note the scale. ______________________________
________________________________________________________________________________________
10. Were skin or tissue specimens from the injury retained? Pathology findings? ___________________________
________________________________________________________________________________________
________________________________________________________________________________________
11. Describe the treatment and medication applied to the injury. ________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
12. Did infection of the lesion occur? How soon? ____________________________________________________

________________________________________________________________________________________
13. Comments by patient regarding the level of pain at the injury site. ___________________________________
________________________________________________________________________________________
E. The Equipment
1. Sketch the positions of equipment, cables, and leads relative to the patient. Do this for operative, recovery room,
and general care settings, as appropriate. Use separate sheets if needed, and attach them to the questionnaire. If
known, indicate where equipment was plugged in and the relative distance from the patient and other
equipment.
2. Describe the condition of all cables, leads, and connectors. _________________________________________

________________________________________________________________________________________
________________________________________________________________________________________
3. Document all switch, control, and indicator settings on all devices used. Were these settings typical
for the procedure? _________________________________________________________________________
________________________________________________________________________________________
4. If a device that was EtO sterilized was touching the lesion, how was the device aerated? __________________
________________________________________________________________________________________
5. Who had contact with the suspect equipment after the incident? _____________________________________
________________________________________________________________________________________
6. Were any inspections or repairs performed? Results? ______________________________________________
________________________________________________________________________________________
7. Have there been any recent malfunctions of devices used in this procedure or similar procedures?
Does the injury possibly relate to device malfunctions recently experienced? Were there any
malfunctions during the procedure? (Review equipment service records for possible information.) __________
________________________________________________________________________________________
________________________________________________________________________________________
8. Was the packaging from suspect disposables saved? ______________________________________________
9. Electrosurgery
a. Determine the following:
i. What was the mode of operation (cut, coag, blend, bipolar)? ___________________________________
ii. What were the control settings for each mode? _____________________________________________
___________________________________________________________________________________
iii. What electrode adapters were used? ______________________________________________________
___________________________________________________________________________________
iv. Does the ESU have a ground-referenced or isolated output? ___________________________________
v. Does the ESU have a return-electrode contact-quality monitor
(e.g., return electrode monitor)? If so, was it used? __________________________________________
___________________________________________________________________________________
b. Was the condition of the ESU cables and connectors checked before surgery? ________________________
c. Was electrosurgery effective at normal settings? _______________________________________________
d. Were ESU settings changed during the procedure? To what? When?
Why? By whom? ________________________________________________________________________
______________________________________________________________________________________
e. Describe the condition of dispersive and active ESU electrodes after the procedure.
Discolored? Charred? Evidence of fluid contact? _______________________________________________
______________________________________________________________________________________
10. ESU Dispersive Electrode
a. Describe the gel condition before and after use. Dry to touch? Viscous or runny? Color? Odor? __________
______________________________________________________________________________________
b. When was the dispersive electrode package opened? ____________________________________________
c. At the time of removal, was the entire electrode surface in contact with the patient? ____________________
______________________________________________________________________________________
d. Were there separations or discontinuities in the foil substrate? ____________________________________
______________________________________________________________________________________
e. Was the electrode checked for proper placement after patient repositioning or checked at
any other time during the procedure? ________________________________________________________
______________________________________________________________________________________
f. Did anyone lean on the dispersive electrode or put tension on the associated cable during the
procedure? _____________________________________________________________________________
______________________________________________________________________________________
g. If injury occurred beneath the dispersive electrode, was the electrode saved? _________________________
544 M.E. Bruley
11. ESU Active Electrode

a. Where was the active electrode placed when not in use during the procedure? Was it placed in a
safety holster? __________________________________________________________________________
______________________________________________________________________________________
b. Was the active cable draped next to any other cables, leads, or conductive tubing
or across the patient? Was it clamped to the drapes? How? _______________________________________
______________________________________________________________________________________
12. Hypo/Hyperthermia Units and Radiant Warmers
a. Record the following:
i. Placement of temperature probes (rectal, esophageal, skin) ____________________________________
___________________________________________________________________________________
ii. Times unit was turned on and off ________________________________________________________
___________________________________________________________________________________
iii. Set temperatures and times _____________________________________________________________
___________________________________________________________________________________
iv. Mode of operation (manual, automatic, warm-up) ___________________________________________
b. Was the temperature of the unit routinely checked? How? Results? ________________________________
______________________________________________________________________________________
c. Was the patient’s temperature routinely checked? How? Results? __________________________________
______________________________________________________________________________________
d. Describe the cleaning/sterilization procedure for the hypo/hyperthermia blanket. _____________________
______________________________________________________________________________________
13. Blanket and Solution Warming Cabinets
a. Were blankets that were warmed in a warming cabinet placed on the patient? Where were they placed? ____
______________________________________________________________________________________
b. Were irrigation solution bags taken from a warming cabinet and placed on or under the patient?
Where were they placed? _________________________________________________________________
______________________________________________________________________________________
c. What was the set temperature on the warming cabinet for both the blanket and the solution chambers?
Was it above 110°F? _____________________________________________________________________
14. Endoscopes and Accessories
a. Is there visible damage to or deterioration of the insulation of the electrosurgical handpiece? ____________
______________________________________________________________________________________
b. Describe the method of cleaning and sterilization of the endoscope and its accessories. _________________
______________________________________________________________________________________
c. Is the fiberoptic cable appropriately matched to the light source? __________________________________
d. Are there damaged fibers within the fiberoptic cable? ___________________________________________
e. Was the fiberoptic cable or endoscope removed while the light source was still powered on? ____________
______________________________________________________________________________________
f. Note the placement of the light source and fiberoptic cable in relation to the patient. ___________________
______________________________________________________________________________________
15. Pulse Oximeters

a. Describe the condition of the pulse oximeter probe and cable. _____________________________________
______________________________________________________________________________________
b. Was the probe used with the correct pulse oximeter? ____________________________________________
c. Was the probe moved during the procedure? __________________________________________________
16. Other Equipment
a. Could other equipment have contributed to the problem? Describe. ________________________________
______________________________________________________________________________________
b. Were difficulties experienced with other devices used? Describe. __________________________________
______________________________________________________________________________________
F. Summary (Interviewee)
1. Other comments?
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
2. Given your observations, how do you think the injury occurred?
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
G. Summary (Interviewer)
1. Highlight salient points gained from the interview.
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
546 M.E. Bruley
Reprinted with permission. Copyright 2005 questionnaire for each person interviewed. If
ECRI Institute. www.ecri.org. 5200 Butler Pike, needed, attach additional sheets to answer ques-
Plymouth Meeting, PA 19462. 610-825-6000. tions. Be sure to record the interviewee’s name
Note: For a detailed discussion of how to use and your name on all attached sheets.
this questionnaire, refer to the text in Chap. 19 To ensure objectivity, no one who had primary
above. responsibility for the patient before or after the injury
Do not file the completed questionnaires with should be included on the team investigating the
the patient’s medical records. incident, but they may well contribute to the investi-
When beginning the investigation of a peri- gation during the interview process. Similarly, engi-
operative skin or tissue injury, record the base- neering or other staff who had responsibility for the
line patient and equipment information first. most recent performance inspection, repair, or cali-
Then, copy the partially completed question- bration of the medical devices suspected of having
naire, and record answers to the remaining been involved in the cause of the injury should not be
questions during each interview. Complete one included on the team.
ppendix 2: Posters—Preventing Surgical Fires and Extinguishing Fires
A
Burning On or In a Patient [41, 42]
Reprinted with permission. Copyright 2009 14. Institute ECRI. Fires during surgery of the head and
ECRI Institute. www.ecri.org. 5200 Butler Pike, neck area [update]. Health Devices. 1980;9(3):82.
15. Koenig TR, Wolff D, Mettler FA, et al. Skin injuries
Plymouth Meeting, PA 19462. 610-825-6000. from fluoroscopically guided procedures: part 1,
Downloadable copies of these posters on pre- characteristics of radiation injury. AJR Am
vention and extinguishment of surgical fires are J Roentgenol. 2001;177(1):3–11.
16. Tucker RD, Platz CE, Landas SK. Histologic charac-
available online at www.ecri.org/surgical_fires.
teristics of electrosurgical injuries. J Am Assoc
For all fires, save involved materials and Gynecol Laparosc. 1997;4(2):201–6.
devices for later investigation. 17. Barach P, Cantor M. Adverse event disclosure: ben-
efits and drawbacks for patients and clinicians. In:
Clarke S, Oakley J, editors. The ethics of auditing
and reporting surgeon performance. Cambridge:
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Improving Clinical Performance
by Analyzing Surgical Skills 32
and Operative Errors
Katherine L. Forsyth, Anne-Lise D’Angelo,
Elaine M. Cohen, and Carla M. Pugh
“Every time a human being touches something it’s likely to go wrong.”

—James Reason
several recommendations surrounding patient

Introduction safety including understanding the reasons for
errors and how to prevent them. While most of
Operative errors play a major role in the safety
the errors noted were attributed to poor communi-
and quality for surgical patients. In 1999, the
cation and team skills, it remains clear that indi-
Institute of Medicine (IOM) released a report esti-
vidual errors still play a role and need to be
mating that between 44,000 and 98,000 patients
addressed. For example, a recent study by
die each year in US hospitals as a result of pre-
Birkmeyer et al. [2] revealed that the technical
ventable medical errors [1]. This report lead to
skills of bariatric surgeons were variable and sur-
geons with the poorest skills had the highest num-
ber of complications. This study and others
support the use of technical skills assessment as
this may be the first step to identifying and learn-
K.L. Forsyth, PhD
Department of Industrial and System Engineering, ing from errors and making a difference in the
University of Wisconsin School of Medicine and safety and quality of surgical care. This chapter
Public Health, 600 Highland Ave, K6/135 CSC, reviews the current skills assessment methods in
Madison, WI 53792-1960, USA surgery, error analysis frameworks, and how we
can improve patient safety through the assess-
A.-L. D’Angelo, MD, MS Ed ment of technical skills and increasing our under-
Department of Surgery, University of Wisconsin
Hospitals and Clinics, 600 Highland Ave, K6/135 standing of errors.
CSC, Madison, WI 53792-1960, USA
E.M. Cohen, MEd
Department of Surgery, University of Wisconsin Surgical Assessment
School of Medicine and Public Health,
600 Highland Ave, K6/135 CSC, Madison, Surgical trainees are required to master a variety
WI 53792-1960, USA of technical skills upon certification [3, 4].
Numerous methods of formal skills assessments
C.M. Pugh, MD, PhD (*) have been developed in order to demonstrate
Department of Surgery, University of Wisconsin—
Madison, 600 Highland Ave, G4/701A, Madison, those competencies. Technical skill was once
WI 53792-7375, USA evaluated through subjective assessment by
e-mail: [email protected] senior surgeons but has transitioned along with

556 K.L. Forsyth et al.
the rise of technology to task-specific checklists into question the ability for the OSATS to differ-
and global rating scales [5]. These methods entiate performance on some operative tasks and
examine surgical performance to evaluate sur- between higher-level performers. Moreover, our
geons’ consistency and patient outcomes. previous research with general surgery chief resi-
Currently, the two most prominent techniques are dents showed variable performance as measured
through observation and technology-based per- by task-specific checklists on three procedures—
formance measures [6, 7]. laparoscopic ventral hernia repair, hand-sewn
bowel anastomosis, and pancreaticojejunos-
tomy—despite relatively high mean OSATS rat-
Observation-Based Methods ings across procedures [13]. In addition, resident
OSATS scores were considerably high in contrast
bjective Structured Assessment
O to low completion rates (range, 25–100 %), sug-
of Technical Skills gesting that individual OSATS global rating scale
Observation-based methods are most frequently items may not be sensitive to variant performance
used to assess surgical technical skills, with the across different procedures. Some also question
Objective Structured Assessment of Technical the objectivity of the tool [12–14], which sug-
Skills (OSATS) at its cornerstone [5]. OSATS gests multiple assessment methods and further
merges task-specific checklists with global rating characterization of errors may be needed during
scales and generic pass/fail judgments to provide certain types of performance assessment.
stronger validity and reliability than the previous
Objective Structured Clinical Examination Checklists
(OSCE) [8, 9]. During an OSATS evaluation, a Task- and procedure-specific checklists are also
participant attempts a number of standardized commonly used to assess surgical skills. A major-
surgical procedures while being observed by an ity of the published performance checklists focus
expert. The expert evaluator uses a checklist to on laparoscopic procedures [11, 15–20]. Eubanks
address specific surgical techniques fundamental et al. (1999) created a checklist for the laparo-
to the procedure, and the global rating scale typi- scopic cholecystectomy procedure that incorpo-
cally focuses on broader surgical behaviors, such rates a raw performance score with an error score
as economy of motion and use of assistants. to provide a more accurate assessment of perfor-
The OSATS (1997) has received mixed mance [15]. While it produced reliable and valid
reviews, as validity evidence is variable. General data, the checklist was inferior to the generic and
surgery residents were evaluated across eight sta- modified OSATS global rating scales when
tions, with OSATS scores improving with each Aggarwal et al. (2008) compared the assessment
postgraduate year [10]. In another study, gyne- tools on a benchmark laparoscopic cholecystec-
cology residents and faculty performed open and tomy procedure [19]. The use of checklists in iso-
laparoscopic tasks for OSATS evaluation and lation has been criticized as there is a tendency to
showed increasing scores on a majority of tasks reward thoroughness and not necessarily compe-
as surgical experience progressed from resident tence [9].
to faculty [11]. On the remaining tasks, there was
no significant difference between resident and lobal Rating Scales
G
faculty scores, with junior residents outscoring Global rating scales are another tool used to eval-
faculty on one task. Another evaluation of gyne- uate technical skill [21, 22]. While checklists are
cology residents in the United Kingdom demon- specific to a procedure or task, global rating
strated that senior house officers scored lower on scales address general surgical skills and trans-
OSATS skills than specialist registrars and con- late easily across procedures. Most scales involve
sultants; however there was no difference in using the Global Operative Assessment of
scores between the higher-level specialist regis- Laparoscopic Skills (GOALS) consists of a
trars and consultants [12]. These studies bring five-item global rating scale that focuses on depth
32 Improving Clinical Performance by Analyzing Surgical Skills and Operative Errors 557
perception, dexterity, efficiency, tissue handling, 34] and the operating room [28]. Additional
and autonomy [22]. Doyle et al. (2007) created validity evidence comes from correlations
the Global Rating Index for Technical Skills between motion metrics and global rating scales
(GRITS) with nine items focusing on respect for [26, 35] and outcome variables [31].
tissue, time and motion, instrument handling/ Of interest is how these motion metrics can
knowledge, flow of operation, knowledge of spe- identify errors in technical performance or even
cific procedure, use of assistants, communication decision-making. Recently, our laboratory has
skills, depth perception, and bimanual dexterity been using motion-tracking technology to inves-
[21]. The seven-item Global Rating Scale (GRS), tigate what occurs when surgeons’ hands are not
initially created for OSATS, though, has received moving [29]. We theorize that periods when sur-
the most attention because ACGME gave GRS an geons’ hands are not moving, termed idle time,
overall Class 1 grade [5, 23]—deeming it a core may represent phases of decision-making or
component for evaluation—and has been operative planning. Recent work demonstrated
assessed across multiple studies [19]. that participants of all experience levels had
greater idle time when suturing on more friable
tissue [29]. Additionally, surgical experience
Technology-Based Performance played a significant role in the distribution of idle
Measures times during the suturing task. Attending sur-
geons had fewer idle periods during the portion
Compared to observer-based assessments, of the task related to placing the needle through
technology-based performance measures may the simulated tissue and greater idle periods
provide more objective methods for assessing while tightening the knot on the suture [29]. This
hands on surgical skill [24]. The integration of combination of video and motion-based assess-
technology during assessment allows for mea- ment can provide information regarding surgical
sures of motion, visual attention, and physiologic skill that may demonstrate differences in techni-
stress during the performance of surgical tasks cal errors not clearly evident with observation
[24]. These measures may provide information alone. The further development and use of optical
integral to evaluating surgical performance that and magnetic motion-tracking technology may
cannot be captured through traditional observer- afford the increased applicability of this assess-
based measures. ment method in the skills lab and the operating
room.
Motion Analysis
Motion analysis relies on electronic sensors or Attention Monitoring Technology
optical systems to capture the movement of sur- Attention monitoring takes into consideration the
geons’ hands or surgical instruments [16, 24, 25]. amount of information that can be processed at a
Surgical efficiency relates to the conservation of given time. Related to cognitive load theory,
time and motion during an operation. Tracking attention levels and characteristics have been
the motion of surgeons’ hands or instruments considered a fundamental limit for human perfor-
provides multiple motion parameters related to mance because it influences the amount of infor-
surgical efficiency: time taken to complete the mation that can be processed at a given time [36].
procedure [26] or subtask [27], the number of Eye tracking technology allows for evaluation of
movements made by each hand [26], the path where surgeons are placing their visual focus and
length of each hand [25, 28, 29], and the three- attention during a task [37]. Recent work by Tien
dimensional working volume of each hand [30]. et al. [38] found differences in expert and novices
These studies [26, 28, 29, 31–33] have demon- visual focus during open inguinal hernia repairs
strated the ability of motion metrics to differenti- performed in the operating room. Experienced
ate performance based on expert versus novice surgeons had greater fixation frequency (rate of
differences both in the simulation laboratory [31, fixed steady eye gaze on an object) and dwell
time (total duration of fixations and saccades on include following procedural steps, dexterity, and
an object) on the operative site during particular instrument and tissue manipulation. The methods
portions of the procedure than less experienced addressed the consistency and outcomes of a sur-
surgeons [38]. This follows from prior work that gical performance. We also discussed the weak-
has demonstrated expert-novice differences in nesses inherent in the current assessment
visual focus during laparoscopic surgery [39]. In methods, such as assessing completeness rather
the future it is possible that this technology could than competence. Surgical skill and surgical
be integrated into error-based assessments by error, though, differ. Incorporating error analysis
providing information regarding visual focus and into surgical skill assessment may provide rigor
attention during specific procedural steps or that current methods lack and identify additional
when errors are occurring. This type of data may areas for improvement. The following section
enhance our ability to study a wide variety of will detail how error analysis has been utilized in
errors and error types including attention. As other fields.
attention serves as a limit to our ability to per-
form information processing including percep-
tion, working memory, decision, and action [36], Error Analysis in Other Fields
further work in this area is necessary.
Errors occur across all fields and can have vary-
hysiologic Stress Monitoring
P ing impact based on the risk level of the area.
Physiologic stress or arousal can contribute to High-risk fields such as aviation, mining, and
increased performance up until a certain point at anesthesia have previously investigated the
which stress becomes excessive, and perfor- nature of errors because they are considered
mance decreases [40]. The operating room is a high-risk fields. They operate in dynamic envi-
high-stakes environment, and the impact of phys- ronments at some level of uncertainty with the
iologic stress on performance is critical to assess- loss of human life as the ultimate consequence of
ing operative errors. Physiologic stress can be failure. Understanding how error assessment has
monitored with contact sensors (measuring heart been performed in these fields will shed light on
rate, respirator rate, sweat gland activation) or the importance of including similar methods into
thermal imaging (measuring blood flow, sweat the previously discussed surgical performance
gland activation, and breathing) [24]. During a assessments. This section will highlight how
suturing task using perinasal thermal imaging, errors have been investigated, identified, and
Pavlidis et al. [41] found that novices demon- characterized in these fields.
strated multiple elevations of thermo-
physiological stress with an increased number of
operative task errors and task attempts. In con- Aviation
trast, experienced surgeons had a low and
unchanging thermo-physiological stress levels In many ways, aviation is seen as the field to first
and higher performance. Ongoing work in this promulgate the notion of error and its role in
field is investigating the role of thermo- accidents. One of the more widely known analy-
physiological stress in surgical performance sis methods, the Human Factors Analysis and
assessment [42]. This technology may prove to Classification System (HFACS) [43], compre-
be a valuable adjunct for assessing performance hensively categorizes human failure based on the
both in the simulation laboratory and the operat- “Swiss cheese” model of human error [44].
ing room with a particular focus on the contribu- Reason (1990) identified four levels of failure:
tion of stress to technical errors. (1) organizational influences can bring about
The performance assessments discussed in the events of (2) unsafe supervision that set in motion
previous sections focused on various methods of any (3) preconditions of unsafe acts that may
surgical skill evaluation. Surgical skills typically result in the (4) unsafe acts of operators [44].
While HFACS includes all levels of Reason’s (7) execution of procedure as intended. The CET
model and presents a systems perspective on provides more in-depth analysis on the previ-
error and accidents, the last level pertaining to ously described unsafe acts identified in the
unsafe acts is most relevant to our discussion. HFACS taxonomy. O’Hare and colleagues (1994)
Unsafe acts of operators are considered errors were able to code 261 of 373 aviation mishaps,
or violations [43]. Where violations require the with procedure errors (26 %) and strategy errors
willful disregard of the rules, errors occur when (19 %) occurring most frequently. A more recent
an individual’s mental or physical activities fail study on military mishaps found action errors
to achieve the intended outcome [44]. In the (30 %) were most common [52].
HFACS taxonomy, an individual can commit By identifying underlying causes of errors,
three fundamental error types: decision, skill- trends in errors can be analyzed to help provide
based, and perceptual errors. insight into interventions and mitigation strategy
Decision errors can occur for various reasons. development. O’Hare et al. (1994) studied avia-
Aviation is highly proceduralized, with explicit tion accidents that involved intermediate-level
processes for nearly all aspects of flight [45]. pilots and found goal-setting errors were com-
Procedures can be misapplied or inappropriately mitted more frequently than procedure or action
used in certain circumstances, and sometimes errors [53]. Wiggins [54] suggests this is due to
situations do not have associated procedures. the culture of aviation. The experience necessary
During these instances, experience, time, and to evolve from an intermediate-level to expert is
external pressures can influence decision-making not obtained from instructional systems, but
and lead to error. Skill-based errors typically rather from repeated exposure; in gaining experi-
occur when a pilot’s attention or memory failures ence, novel situations will occur that require
impact basic flight skills. Perceptual errors hap- knowledge intermediate pilots do not yet possess.
pen during “visually impoverished conditions,” Wiegmann and Shappell [55] identified addi-
such as night flying or inclement weather, where tional trends using multiple cognitive models to
the pilot responds incorrectly to the disorienting analyze over 4000 aircraft accidents. Minor
conditions [45]. trends were associated with procedural and exe-
HFACS has been used in commercial and gen- cution errors, while errors surrounding decision-
eral aviation [45–48] and abroad [49–51]. making, setting goals, and choosing strategies
Multiple causal factors for aviation accidents in were linked with major accidents. For licensed
China were identified with perceptual, skilled- pilots with over 2000 h of flight time, reported
based, and decision errors present in 22.2, 43.2, accidents associated with goal selection were
and 42.6 % of events, respectively [51]. An inves- most common at 27 %, while information errors
tigation into civil aircraft accidents in India also were most prevalent (28 %), partially supporting
identified skill-based and decision errors as the the previous claim [56].
most frequent in unsafe acts [50]. US investiga-
tions also support this finding, with skill-based
errors associated with 79.2 % of general aviation Mining
accidents [45].
Cognitive failure analysis presents another The mining industry remains one of the highest-
perspective to analyze aviation errors [52, 53]. risk professions [57]. Despite significant
The Cognitive Error Taxonomy (CET), modified improvements in safety, human error still plays a
from Rasmussen (1982), describes six steps in role in 85 % of mining accidents [58]. Using inci-
information processing: (1) opportunity for inter- dent and accidents reports, an analysis on the
vention, (2) detection of cues from change in sys- causal factors of the events was performed using
tem state, (3) diagnosis of system state, (4) setting HFACS-MI, a modified HFACS framework for
of an appropriate goal, (5) selection of suitable the mining industry (MI) [59]. Unsafe acts were
strategy, (6) adoption of a suitable procedure, and prevalent and identified in almost all cases, with
skill-based and decision errors occurring more incorrect observations [63]. Anesthesiologists
frequently than perceptual errors. Skill-based must also prioritize problems based on severity
errors identified included omitting operations or and urgency and consistently reevaluate the cur-
inadvertently including operations and errors in rent environment. Prior to taking any action, they
technique. Decision errors that occurred fre- must weigh the options against preexisting
quently involved misapplying procedures for a patient conditions, side effects, efficacy, and
given task and identifying hazards and taking reversibility. All of these decisions have the
appropriate measures. Interestingly, decision potential for error.
errors varied significantly by mine type (p < 0.05), The procedural level in anesthesia consists of
suggesting that the setting influenced the infor- observation, verification, and problem recogni-
mation available or knowledge necessary to make tion. Incorrectly assessing or misdiagnosing
correct decisions [59]. abnormalities is a common error at this level
[65], as well as leaving out steps. At the sensory/
motor level, anesthesiologists choose and per-
Anesthesia form actions skillfully and with intention. Skill-
related errors can occur at this level when
In medicine, the field of anesthesia has also technique is poor or an action is unintentionally
sought to address the issues surrounding human performed.
error. Similarly to aviation, understanding error Each field experiences unique issues pertain-
in anesthesia has been analyzed with multiple ing to their area, but the methods of analysis and
approaches. Anesthesiologists described mis- types of errors can carry over across domains.
takes previously committed or observed and The next section will address how errors are cur-
identified many events, including issues in equip- rently assessed and analyzed in the field of
ment, unintentional overdose of drugs due to surgery.
technical or judgment errors, and misuse of mon-
itoring equipment [60, 61]. By identifying these
critical incidents, it provides context to where Errors in Surgery
errors occur.
Others have looked into the role of decision- As a surgeon, performance in the operating room
making and cognition in error [62] because of the (OR) requires the balance of an already complex
high cognitive demands placed on anesthesiolo- environment. The elements of the OR—staff,
gists. A framework based on the work of procedural complexity, equipment, environment,
Rasmussen (1982) and Reason (1990) recognizes and the patient—are interconnected [66], each
four levels of work performed by an anesthesiol- with their own level of uncertainty or unpredict-
ogist: (1) sensory/motor, (2) procedural, (3) ability. On top of it all, the life of the patient
abstract, and (4) supervisory control [44, 63, 64]. imparts a high level of risk that affects each ele-
The first three levels map onto Rasmussen’s ment in its own way. Making mistakes or com-
skills-rules-knowledge framework (1982), while mitting errors in everyday life can sometimes
the supervisory control level addresses coordi- have significant negative consequences; in the
nating between the anesthesiologist and others OR, that likelihood is tenfold. The following sec-
and appropriating attention between different tions discuss the identification and understanding
problems [63]. of errors in surgery.
At the supervisory level, anesthesiologists
tackle multiple streams of data, including the
patient, surgical field, multiple monitors, and any Malpractice Claims Studies
conversations or alerts, in order to identify and
assess any problems that arise. These data streams One of the initial methods to understanding the
increase the possibility of faulty perception and operative errors began with malpractice claims
investigations. In a major study investigating Joice et al. [70] used human reliability assess-
technical errors across surgical specialties, gen- ment (HRA) to evaluate task performance on
eral and gastrointestinal surgeries were most com- video-recorded laparoscopic cholecystectomies,
monly associated with error (31 %) [67]. The demonstrating the feasibility of this type of analy-
study considered technical errors as failures in sis in the surgical domain. Error modes, describing
execution (i.e., manual performance) or planning the different ways in which an error could occur,
(i.e., decision-making and judgment), with execu- were identified in the procedure along with any
tion errors occurring most frequently (91 %). The consequences. Errors were later separated into
most common execution errors included inciden- errors of procedure or execution. Procedural errors
tal injuries to internal anatomy, breakdowns of the involved performing a step correctly with step(s)
repair, and hemorrhage, while recurrent planning reordered or omitted, while execution errors were
errors included delay or error in intraoperative considered when the step(s) was physically per-
diagnosis/management. Like the above studies formed incorrectly. Approximately 190 errors
mentioned, Regenbogen et al. [67] also recog- were identified in 20 procedures, with a majority
nized the interplay between execution and plan- of them identified as execution errors. Gallbladder
ning errors and found 26 % of errors were perforation was the most common consequence,
characterized by both execution and planning occurring in 15 of the 20 procedures.
issues. Numerous errors occurred in routine oper- The HRA method was later developed into a
ations (84 %) by experienced surgeons (73 %) but larger system called Observational Clinical
also involved complicating factors such as patient Human Reliability Assessment (OCHRA). Tang
complexity or systems issues (69 %), suggesting et al. [71] used OCHRA to understand errors in
even the most experienced surgeons are still sus- laparoscopic cholecystectomy procedures based
ceptible to error. Others investigated trainees and on whether the error’s impact was consequential
their role in surgical error. One study identified or not. Consequential errors were considered
similar cognitive errors between surgical trainees events that required corrective measures, while
and non-trainees, with flaws and failures in judg- inconsequential errors only increased the possi-
ment as one of the most prevalent contributing bility of undesirable consequences. Of 20 proce-
factor to errors [68]. In another study, residents dures observed, 30 % of the errors identified were
self-reported complications and the potential for with consequence, with diathermy burns to the
errors, identifying up to five error types per com- liver and perforation of the gallbladder classified
plication [69]. Residents reported errors of tech- most frequently. Inconsequential errors usually
nique most frequently (63.5 %) while cognitive involved inappropriate tissue grasping, over-
errors in judgment (29.6 %), inattention to detail shooting instrument movement, and not visual-
(29.3 %), and incomplete understanding (22.7 %) izing an instrument’s tip during dissection. While
were still commonly reported. a majority of the surgeons were first-year resi-
dents, the study shows propensity to commit
errors varies widely.
Observational Studies Lien et al. [72] used a different approach to
error analysis. Recognizing a high incident rate
Observational studies can provide a different per- of common bile duct (CBD) injury during LC
spective in characterizing surgical error by procedures, videos were retrospectively analyzed
including the visual layer sometimes necessary to to understand the events that led to a CBD injury
truly understand the context and underlying etiol- [72]. Surgeons frequently committed errors by
ogy of errors. A majority of studies focused on omitting or incorrectly performing procedure
minimal access surgery because laparoscopy steps, such as not fully exposing Calot’s trian-
involves the additional challenge of remote visu- gle—a critical step in performing LCs—causing
alization and limited tactile feedback during surgeon’s to misidentify anatomical structures.
surgery. The study also broadened beyond the surgeon’s
technical performance and identified two addi- completed the procedure successfully on the
tional factors that contribute to the injury—the following day with fewer decision-making
patient, such as concomitant diseases, and envi- errors.
ronmental factors of the OR and surgical field, Our laboratory further investigated the surgical
such as poor lighting or inexperience of assis- performance of the senior residents and catego-
tants. Once these factors were identified, a check- rized errors committed using video recordings of
point system was developed to encourage each procedure [76]. A cognitive error taxonomy
reviewing performance at critical procedure steps [53, 64] identified error levels and omission-
in order to prevent these errors leading to a sig- commission categories characterized each error.
nificant reduction of CBDs in the second half of Combining classifications further clarified the
their study. understanding on the residents’ performance, by
Utilizing video-recorded procedures for error identifying how a resident failed to understand the
analysis was popular in the literature with few environment or make incorrect diagnosis or strat-
assessing surgical performance in the OR. egies (cognitive errors), or failed to include proce-
Mishra et al. [73] observed laparoscopic chole- dural steps or performed them incorrectly
cystectomies to understand the relationship (technical errors). Procedure steps were also iden-
between nontechnical teamwork skills and tech- tified and used to compare error types and levels
nical error. The HRA and error modes described across the entire LVH repair procedure (see
previously were used in the study [70]. Technical Fig. 32.1). Residents struggled on the first day
errors were identified approximately three times during the mesh preparation steps and made more
per procedure on average and were strongly cognitive errors in mesh sizing, mesh suture
negatively correlated to the surgical team and placement, and mesh insertion. On the following
surgeon’s subteam situational awareness [73]. day, error-type prevalence changed, as resident
These findings highlight the important role cog- remembered or learned to include more steps of
nitive skills play in surgical errors. the procedure and committed more commission
Simulation provides additional opportunity (86 %) than omission (14 %) errors (see
for error analysis without risk to patient mortal- Table 32.1). Our findings show that our error
ity. Using an error-enabled laparoscopic ventral assessment method was able to detect changes in
hernia (LVH) simulator [74], senior general sur- performance after receiving feedback and addi-
gery residents were assessed on their surgical tional training, even at the level of a novice.
performance using a scored sheet created based Additionally, our findings support the previously
on Rasmussen’s skills, rules, and knowledge discussed studies showing current assessment
framework [64, 75]. Residents received feed- methods, and the more broadly understood surgi-
back and returned the following day to reat- cal performance, should be expanded to evaluate
tempt a non-equivalent simulated LVH intraoperative knowledge and skill.
procedure. On the first day, 75 % of residents The studies previously discussed demon-
failed to complete the LVH procedure success- strate how broadly errors and surgical perfor-
fully. Common errors involved improper visual- mance have been understood. Using multiple
ization of the suture passer, preparing the mesh methods of investigation (malpractice claims,
incorrectly prior to insertion, and omitting video-r ecorded surgical procedures, and sim-
anchoring sutures. After receiving feedback, ulation), these studies defined errors as inci-
residents committed fewer decision-making dents in physical skill and technique, failures
errors during port placement and mesh prepara- in procedural understanding, and higher-level
tion on the following day, which enabled them issues in judgment and decision-making. The
to progress and complete the procedure. This following section will address what these
suggests incorrect decision-making and judg- findings mean for the future understanding of
ment can be highly impactful to progressing surgical performance and surgical assessment
through a surgical procedure, as all residents as a whole.
Fig. 32.1 Proportion of cognitive versus technical errors during each step of the procedure
Future Directions discussed. In order to move forward, an error

nomenclature needs to be further developed.
efining “Error” and Understanding
D Evaluating the applicability of errors assessments
Error Management employed in other fields provides a broad frame-
work for assessing errors in surgery. This will
Humans, across all fields, regardless of their allow for easier methods of comparing across
expertise are fallible, yet there is not one consis- studies and identifying areas of improvement not
tent definition of surgical errors across the studies only for senior surgeons but residents as well.
Table 32.1 Details of intraoperative errors on Day 1 and cal skill. These methods, however, fail to provide
Day 2
a more thorough understanding of the underlying
Day 1 Day 2 p-value causes and characteristics of surgical perfor-
Total LVH completion mance failures [76, 87]. Incorporating error anal-
No. (%) of residents 1/7 7/7 0.001 ysis into future assessment methods may
with complete repairs (14 %) (100 %)
highlight areas for improvement so that surgeons
Total number of errors 121 146
can identify their weaker surgical skills, whether
Mean (SD) participant 17.3 20.9 0.26
errors (4.3) (5.8)
that be in technique or judgment and decision-
Error type making, and address them through intentional
No. (%) of omission 40 20 <0.001 and deliberate practice [88, 89].
errors (33 %) (14 %)
No. (%) of commission 81 126
errors (67 %) (86 %) Integrating Technology
Error level and Observation-Based Methods
No. (%) of cognitive 45 35 0.019
errors (37 %) (24 %)
There is promise in some of the newer technolo-
No. (%) of technical 76 111
errors (63 %) (76 %)
gies that are currently in development. Sensor
technology has been applied to multiple clinical
exams, including the pelvic and breast exams, to
Studies have shown that surgical performance assess the role of palpation in performance.
and patient outcomes are related [2, 77–80] and Sensor technology demonstrated that differences
also that the operative environments in which in palpation force and the technique used plays a
surgeons work impact surgical performance in role in exam accuracy and proficiency [24, 90].
decision-making and technique [81–83]. By Pixel-based motion tracking is another promising
developing a more concise definition of surgical area that could be used to identify trouble areas
error, understanding the relationships between or skills for improvement. Pirsiavash and col-
errors and patient outcomes and the surgical leagues (2005) have used this method in combi-
environment could improve and aid in interven- nation with video-recorded performances to
tion development to reduce possible disruptions. predict performance scores for Olympic athletes
While these studies focused on understanding [91]. A similar approach could be used in surgery
and defining surgical errors, there was little dis- to predict patient outcomes based on surgical per-
cussion in how residents and senior surgeons formance. Additionally, progress is currently
compensated for their actions or decisions once being made to automate the understanding of
an error was committed. Aviation, nuclear power, human behavior [92]. Using methods such as
and various other industries have identified error cognitive task analysis, similar research could be
management as an important, if not critical, skill performed to automate the understanding of sur-
to have. While the traditional method of surgical gical behavior and identification of surgical error.
education pushes error avoidance, studies have Ultimately, using technology-based assessment
demonstrated that those trained in error manage- methods in complement with observational
ment fair better [84]. Incorporating this skill set methods can provide additional understanding in
into future resident training and continuing edu- surgical performance that has not yet been
cation for established surgeons may not eliminate addressed.
the errors committed intraoperatively, but possi- Regardless of how surgical errors may be
bly improve their consequences and more impor- defined or what methods we use to assess and
tantly patient outcomes [85, 86]. analyze performance, without a shift in the cul-
The current assessment methods described ture of the surgical community, we will fail to pro-
previously primarily focus on procedure time and vide valuable and much needed error-based
both subjective and objective measures of techni- assessment knowledge to the medical community.
In addition, HIPPA laws and regulations must be 8. Harden RM, Stevenson M, Downie WW, Wilson
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Part IV
Approaches to Managing Risks
Perioperative Risk
and Management of Surgical 33
Patients
James M. Levett, Susan Mellott,
Anngail Levick Smith, James M. Fasone,
Stanley S. Labovitz, Jennifer Labovitz,
“The major difference between a thing that might go wrong and a thing that cannot
possibly go wrong is that when a thing that cannot possibly go wrong goes wrong, it
usually turns out to be impossible to get at or repair.”
—Douglas Adams
surgeon’s schedule from the office listed patients in

Overview of Risk Management the order 1,3,2, while the anesthesia and OR sched-
ules listed the patients as 1,2,3. On the day of sur-
Clinical Case gery, the patients were admitted to the pre-op area
of the hospital and the registered nurse (RN) com-
pleted a verification process between the surgical
A busy orthopedic surgeon scheduled two cases for consent and consult notes from the physician.
knee replacement surgery on the same day. His Patients 2 and 3 were in rooms next to one another.
office later added a third knee replacement case to The pre-operative area contains a white board and
the middle of the string rather than at the end of the the RN places a check by the surgeon’s name and
string as is customary when additional cases are anesthesiologist’s name when they each see the
added in this setting. Patients 2 and 3 had different patients. After finishing surgery on patient 1, the
laterality and were not in the same order on the sur- surgeon saw his next patient, patient 3, on his
geon’s schedule compared with the planned operat- schedule, and informed the nurse that he had seen
ing room (OR) and anesthesia schedules. The and marked his next patient. The RN then placed a
J.M. Levett, MD (*)

Department of Surgery, UnityPoint
St. Luke’s Hospital, 1026 A Ave. NE, Cedar Rapids,
IA 52402, USA
e-mail: [email protected] S.S. Labovitz, BSBA, JD
S. Mellott, PhD, RN SurveyTelligence, an InfoTool Company,
Department of Nursing, Texas Woman’s University, 2640 Lake Shore Drive, Riviera Beach,
6700 Fannin Street, Houston, TX 77030, USA FL 33404, USA
A.L. Smith, BA, MA J. Labovitz, BS
Operations, CRG Medical, 9700 Bissonnet Street, 536 Tremont St, Boston, MA 02116, USA
Suite 2800, Houston, TX 77036, USA e-mail: [email protected]
e-mail: [email protected] D.B. Dotan, MA, CQIA
J.M. Fasone, ARM, RPLU Patient Safety Evaluation IT, CRG Medical, Inc.,
CRG Medical, 9700 Bissonnet Street, Ste 2800, 9700 Bissonnet Street, Suite 2800, Houston,
Houston, TX 77036, USA TX 77036, USA

check mark by patient 2’s name (when the surgeon • Risk must be identified before it can be mini-
had actually seen patient 3). The OR circulator
mized/prevented [4, 5]
checked the board, determined that both the anes-
thesiologist and surgeon had seen the patient, and
proceeded to interview patient 2. The circulator In the surgical setting, risk is a fact of life and
noticed that the patient had not been marked and must be considered in everything that touches and
informed the supervisor who went to the lounge to
interacts with a patient. All policies, procedures,
talk to the surgeon. The surgeon informed the
supervisor that he is sure he had just marked the and processes must be designed and developed
patient and instructed the nurse to have the patient with the idea of identifying risk and minimizing it
taken to the OR. The nurse followed this directive when feasible. This means that measures must be
and the patient was taken to the OR where anesthe-
adopted to standardize workflow, order sets, and
sia was induced and the patient was intubated. The
surgeon scrubbed, entered the room and noticed procedures as much as possible [6]. Success
that the patent was not marked. He then broke depends upon many factors, but the development
scrub, called his office to obtain an imaging study, of and experience gained by a surgical team that
reviewed the chart, noted the name discrepancy,
works together, learns from its experiences, and
reviewed the radiology report, and verified the
patient’s name with anesthesia. The circulator then supports team members is probably most impor-
asked the charge RN to verify the site with the fam- tant [7]. Communication among team members is
ily, and the surgeon proceeded with the knee of course critical in any perioperative environment
replacement on the correct side.
and is greatly facilitated by a culture of transpar-
ency and safety, as well as structural elements such
This case study illustrates a near miss and raises as checklists and a governing council [8].
important questions about risk and how one thinks
about it in the surgical setting [1]. The order of the
cases was not the same on the surgeon’s schedule Individual Risk
as it was on the OR and anesthesia schedules which
led to a series of miscommunications that were The calculation of individual risk relies upon
only discovered because enough safeguards were assessment of inherent procedure difficulty,
in place to eventually correct the error. It is clearly comorbidities, urgency, and the experience of
important to have a system with standardized poli- the OR team, anesthesiologist, and surgeon. The
cies and procedures, trained personnel, and a cul- structure or setting may also contribute to risk in
ture of communication among all caregivers [2]. the sense that an outpatient facility may not be
Joseph Juran, one of the quality gurus of the appropriate to handle cases that would normally
twentieth century, is quoted as saying: “A principal be performed in a hospital operating room.
finding has been that…quality problems are The actual measurement of risk is not usually a
planned that way, which means that the quality simple proposition, and for the individual patient,
problems are largely traceable to deficiencies in several risk calculators have been developed to
the methods used to plan for quality. Those defi- assist surgeons and anesthesiologists in assessing
ciencies are still in place. To get rid of those defi- risk. In 2013, the American College of Surgeons
ciencies we must revise the quality planning and its National Surgical Quality Improvement
process and then learn how to acquire mastery over Program (NSQIP) developed a web-based surgical
that revised process.” [3] risk calculator that is designed to take those indi-
Juran made the point that planning for quality is a vidual data and calculate the surgical risk for com-
necessity for any organization, and although this has plications and possible death [9]. This tool was
many facets, risk and safety planning are certainly at a compiled from statistical data collected from 1.5
high level of importance for any healthcare organiza- million patients, allowing the surgeon to adjust the
tion. While risk has been defined in many ways, the risk factors for each patient utilizing 21 preopera-
definitions usually contain the following elements: tive factors. The tool contains a feature where the
surgeon, based on the surgeon’s experience and
• Risk involves potential harm or loss evaluation of the patient, can adjust the score for a
• Risk can be costly patient. There are similar surgery risk calculators
• Risk can be traumatic developed by other healthcare organizations [10].
33 Perioperative Risk and Management of Surgical Patients 573
These include risk calculators for large bowel overriding theme is the importance of culture both
obstructions, lymph node harvesting, colorectal within the perioperative environment and through-
laparoscopic conversion, ileal pouch failure, car- out the organization. This is discussed in detail in
diothoracic surgery (Society of Thoracic Surgeons Chap. 6 within the section entitled, Overview of
risk calculator), and several others. Practitioners Enterprise Risk Management.
can find information on surgical risk calculators on
the internet [11, 12].
Phases of Care
Process Risk
Patients move through different care settings or
Process risk can be thought of as the inherent risk of phases of care within the perioperative environment
the procedure or the risk of a particular process in a and the goal is to quantify risk at the process level
phase of perioperative care [13]. It has to do with for each of these phases of care. The methodology
the complexity and difficulty of the surgery, but also described in this section may not be practical for
includes the following types of variables that can patients in all care settings, but it provides a frame-
affect the outcome either directly or indirectly [14]. work in which to think about providing care for
Examples of process risk are listed in Table 33.1. each patient in a way that minimizes risk. Having a
We consider the inherent risk of the process for system allows all providers to communicate and
the “average” patient, and then compare this risk share information within the clinical setting at the
to the risk for the patient under consideration with point of care. Although risk factors can produce
various comorbidities. In this way, we are able to complications in any care setting, it is often unclear
determine if there are specific steps or processes how these risk factors are linked to specific care
within the overall care experience that are particu- processes. Each setting is associated with processes
larly risky for this patient and that should be noted that are common to the care setting and others that
by the providers caring for the patient. are unique to the particular disease or diagnosis.
Examples of common processes include:
• Hemodynamic management process

Risk Engineering • Imaging/testing process
in the Perioperative Environment • Medication process
• Nutrition process
There are many ways to think about risk in the • Ventilation process
perioperative setting, and we have summarized the
general concepts in the section below entitled, These common processes could involve virtu-
Other Factors in Managing Patient Safety Risk. In ally all areas (phases of care) the patient pro-
this section we discuss a methodology to quantify gresses through during an episode of illness. The
risk using analyses based on the phases of care. An phases of care are listed in Table 33.2.
Table 33.1 Examples of process risk Table 33.2 Phases of care

Communication complexity/dissemination Initial visit/consult
IT/information needs Preoperative work-up and testing, imaging, consults
Program management Preoperative day of surgery
Resource management Intraoperative
Service structure Immediate postoperative in PACU or ICU
Service area issues Postoperative in hospital
Team size and makeup Discharge planning
Team skill and stability Follow-up post-discharge
Each phase of care may contain a few steps/ Quantifying Risk in the Care Setting
processes or many, and each step may present a
risk if it is not executed properly. Something as The next step is to quantify risk in each phase of
simple as placing an order for laboratory tests care by mapping the overall process and identi-
has inherent risk since the wrong test may be fying each step in the phase of care. The risk
ordered, review of the test result may not hap- may then be quantified using the tool Failure
pen, or the test may be ordered on the wrong Mode Effects Analysis (FMEA). A FMEA is a
“Mr. Smith.” The system described in the fol- well-described and proven methodology used by
lowing subsection is a methodology for quanti- industrial engineers and quality managers. It can
fying risk for each process and at each process be adapted to the surgical setting in order to
step if desired. It is based upon making a judg- assess and quantify patient risk. The FMEA uti-
ment about how often something goes wrong, lizes three parameters to calculate a Risk Priority
how bad the outcome may be when it does, and Number (RPN) for each risk that has been identi-
how easy it is to detect or predict the adverse fied (Figs. 33.1 and 33.2). The three factors are:
event or mistake. While many steps in many frequency of occurrence, severity, and likelihood
processes may indeed be the same for most of detection. Each of the three factors is usually
patients, some steps have risks that are higher given a scale range of 1–10 with the RPN being
for some patients than others, and the increased the product of the three factors, ranging from 1
risks are usually due to comorbidities. After to 1000. Risk factors that are low frequency or
looking at the processes and steps, we deter- low severity or have a high likelihood of detec-
mine which aspects of this episode of care are tion would be assigned low numbers, while
particularly important/risky for this patient. higher numbers would be assigned to risk factors
Another way of looking at the issue of risk is with high frequency, or high severity, or a low
to understand that there is an inherent risk for likelihood of detection. We prefer this methodol-
any procedure—the process risk or “being in ogy in the clinical setting since the ability to
the hospital” risk. Additional risks are pro- detect or predict the risk is important from a
duced by comorbidities and risk factors associ- safety standpoint. Most organizations with for-
ated with an individual patient, their care mal enterprise risk management (ERM) systems
providers, and the hospital or environment of utilize a simpler version with only the parame-
care [15, 16]. ters of frequency (likelihood) and severity
The questions listed in Table 33.3 may be used (impact) to derive a risk score in the range of
to assess these risks. 1–100 (in the case of a scale of 1–5 rather than
1–10 for each factor, the range would be 1–25).
For both RPN and risk score numbers, the scales
of 1–5 for each parameter are easier to use and to
Table 33.3 Questions to assess process risk make decisions, while the scales of 1–10 afford
How is the process/phase of care evaluated for risk more precision and are preferred in engineering
and safety issues? work.
How do these relate to the individual patient? The FMEA methodology may be utilized to
Does an individual patient have specific, unique risk
assess risk for each process/step in each phase of
factors that need to be taken into account?
care for an individual patient. This is done by
Which care processes/steps are affected by the risk
factors? comparing the risk of an average patient to the
If risk is identified, how is it quantified in order to risk of the specific patient being treated. It is
determine if it’s significant or not? important to keep in mind that the numbers
How is the information reported and communicated to assigned to each risk factor are estimates derived
the care team? by the team performing the assessment, data from
Is decision support provided by the system? registries, databases, or published journal articles
Fig. 33.1 Risk Priority Number (RPN)
Obese, albumin <3.5 g/dL 7 × 5 × 1= 35
In this example, we estimated that without obe-

sity, the severity (S) of wound dehiscence would
rate 5 on a scale of 1–10, the frequency (F) would
rate 3, and the detectability (D) would rate 1,
amounting to an RPN value of 15. For the obese
patient with a low albumin, the severity rate is 7,
frequency 5, and detectability 1, leading to an
Fig. 33.2 Risk rating scales for calculating RPN RPN of 35. The risk for this patient having a
wound dehiscence is therefore over twice as high
as the average patient, so using retention sutures
utilized to assist in making the estimates. Although might be a good idea.
the risk is the same most of the time in the pre-op A second example involves a morbidly obese
phases of care, it could certainly be increased for patient undergoing a colon resection:
a patient with complex problems who requires
dialysis and imaging studies for staging prior to • Colon resection: Instrument, needle,
lung resection. Planning each step in the pre-op sponge count
time period would be very important for the –– Disease entity: Colon resection for cancer
patient, and knowing where to look for potential –– Complication: Retained sponge
problems is the value of this methodology. –– Risk factor: Morbid obesity
Another example is the intraoperative phase –– Care setting: Operating room
of care in an obese patient with an albumin 1.9 g/ –– Process: Instrument, needle, and sponge
dL undergoing an exploratory laparotomy for count
small bowel obstruction. The RPN for the wound –– RPN:
closure process is calculated twice: Not obese (S × F × D) 2 × 3 × 2 = 12
Obese 3 × 5 × 4 = 60
• Exploratory laparotomy for bowel obstruc-
tion: Wound closure process The obesity in this case increases the fre-
–– Disease entity: Small bowel obstruction quency of a retained sponge as well as reducing
–– Complication: Wound dehiscence the detectability, so that the RPN is 5× higher in
–– Risk factors: Obesity, albumin <3.5 g/dL the obese patient.
–– Care setting: Operating room A third example involves mapping out the key
–– Process: Wound closure processes in a coronary artery bypass operation
–– RPN: (CABG) during the intraoperative phase [17, 18].
Not obese, albumin >3.5 g/dL (S × F × D) The 15 processes listed in Table 33.4 each include
5 × 3 × 1 = 15 several different steps.
Table 33.4 Key processes in a coronary artery bypass Table 33.5 Summary of using FMEA methodology in
operation the perioperative setting
Anesthesia process Determine which care settings or phases of care are of
Non-anesthesia medications process interest or concern
Chest-opening process Map process steps within each care setting and
calculate the RPN for each key step for the average
Conduit preparation process
patient without known risk factors or comorbidities
Cannulation process
List risk factors/comorbidities for an individual patient
Cardiopulmonary bypass (CPB) process
Determine which care processes/steps are affected by
Myocardial protection process the risk factors
Distal/proximal anastomosis process FMEA analysis of each process step
Weaning CPB process FMEA combined with known risk factors and
Decannulation process comorbidities
Determination of most important and risky process
Checking conduit process
steps based on RPNs with differences between
Hemostasis process patient being treated and average RPN
Drainage process Assess RPN values based upon
Sternal closure process Absolute values of RPN
Transfer process Percent changes in RPN after risk factor
adjustment
Number of RPN values affected by risk factors
One could list all steps in each of these pro- Provide decision support to care team within each care
setting
cesses and develop a RPN number for each step.
Effect of combining risk factor analysis with FMEA
In this example, we choose to evaluate protamine Quantify processes
administration to reverse heparin that is part of Quantify risk
the hemostasis process. Giving protamine can Understand system of care
produce a reaction resulting in acute pulmonary Information available at point of care
Improve patient safety and prevent errors
hypertension and right ventricular failure in
patients with risk factors including insulin-
dependent diabetes mellitus, history of previous P ractical Applications of the FMEA
cardiac surgery, previous vasectomy, and/or fish Methodology
or seafood allergy. The calculations would be as
follows: The FMEA methodology is a powerful tool to use
in assessing risks, and it can result in improved
• Cardiac surgery using cardiopulmonary patient safety and fewer errors. The recommended
bypass: Protamine administration process method is summarized in Table 33.5.
–– Disease entity: Coronary artery disease
–– Complication: Protamine reaction
–– Risk factor: Insulin-dependent diabetes Other Factors in Managing Patient
–– Care setting: Operating room Safety Risk
–– Process: Protamine administration
–– RPN: The risks to patient safety in surgical care come
No diabetes (S × F × D) 6 × 4 × 1 = 24 from individual practitioners, equipment failures,
Insulin-dependent diabetes 9 × 7 × 1 = 63 lack of having correct supplies, and many other
factors. All organizations that provide surgical ser-
The history of insulin-dependent diabetes in vices should conduct a patient safety risk assess-
this patient increases the RPN by a factor of 2.6, ment at least annually to identify opportunities for
thereby alerting the team to be cautious in giving improvement. Once these opportunities are identi-
protamine and not removing the cannulae until fied, an action plan must be developed and imple-
later in the process of giving the protamine. mented, and the results must be sustained.
Process Oliveria [26] concluded that 38 % of the articles

reviewed showed a relationship between the use
The high complexity of performing surgery and of the surgical checklist and a reduction in surgi-
the increasing need for complicated device tech- cal morbidity and complications, while 46 % of
nology increase the potential for medical errors the articles suggested a need for surgical safety
and adverse events to occur. Safety systems must improvement. Urbach et al. showed clearly that
be in place to help reduce the chance of these without engagement of the surgical team, the
errors occurring [19]. One method to determine benefits of the surgical checklist are greatly
the current state of patient safety in the surgical diminished [27] and despite great efforts, only
arena is through a patient safety culture assess- minimal gains are achieved [28].
ment. There are some assessment tools developed Another potential risk in the surgical arena is
explicitly for surgery, and there are tools devel- the risk of fire (see Chap. 20). Seifert et al. [29]
oped that include the surgical area of care [20]. state that the surgical team must be aware of the
Two of the best-known tools were created by the potential for fires and complete an assessment to
Agency for Healthcare Research and Quality determine that the three elements of fire—fuel,
(AHRQ) [21]. The safety culture survey is given oxygen, and ignition source—are controlled.
to the staff to complete and is then analyzed with The Association of periOperative Registered
the facility receiving a report benchmarking it Nurses (AORN) has developed a five question
with similar facilities. The data in the report may perioperative fire risk assessment that can be uti-
be utilized to make improvements in the patient lized to evaluate the location of the surgery,
safety culture of the organization. types of anesthesia, antiseptic cleansers, and
Unfortunately, it is not possible to predict and energy sources which could lead to a fire [30].
prevent errors in the surgical arena, but there are Seifert et al. also stress that education of the sur-
many educational and process changes that can gical team is essential in not only knowing how
help to reduce the likelihood of harm occurring to prevent a fire but also in knowing the role of
[22]. There has been a movement in healthcare to each team member should a fire occur.
put processes in place which will provide redun- These examples include a large element of
dant checks prior to and during a surgical proce- human factors that greatly influence the risks
dure. The Joint Commission (TJC) developed the that are present in the surgical environment
Universal Protocol for use in all surgical settings [31]. Adverse events in surgery commonly
in facilities that they accredit [23]. The Universal occur due to a lack of communication, a delay
Protocol includes verification of information in diagnosis or failure to diagnose, or a delay
when the patient arrives for the procedure through in treatment [32]. The entire team must adopt a
the start of the procedure, the marking of the culture of safety and be ever vigilant prior to,
operative site, and a time-out before the proce- during, and after the procedure. Everyone must
dure begins to assure that all the necessary infor- work as a team and be willing to speak up
mation, equipment, and supplies are ready in the should a team member determine that some-
operative area. Surgical checklists have been thing is not as it should be [33]. If the culture
developed from TJC Universal Protocol, or from of the organization is not a patient safety cul-
the World Health Organization (WHO), for all ture, members of the team may not feel com-
areas where procedures are performed [24]. fortable speaking up if a person of perceived
Although these checklists have been in place for power is about to make a mistake. The patient
many years, they are not always utilized in the safety culture in the surgical arena is character-
correct manner [25]. A study by Araujo and ized by the elements listed in Table 33.6.
Table 33.6 Characteristics of a patient safety culture dangers with HIT interconnectedness. Through
Reporting culture without fear of reprisal the use of the EHR and other electronic com-
Learning culture where team members learn from their munication devices, practitioners can select
successes and failures hyperlinks and in some cases QR codes that
Flexible culture that changes and adapts to meet new will lead them to more information concerning
demands
any topic. A QR code (abbreviated from Quick
Engaged culture where everyone does their part
Response code) is the trademark for a type of
Just culture where every team member is treated fairly
matrix barcode, made up of black square dots
arranged in a square grid on a white back-
Dangers of Technology ground. Any imaging device, such as a scanner,
camera, or smartphone, can read the QR code
Advances in healthcare technology have and open or link to information or connect to a
improved the accuracy and minimized the risk to database. The barcode idea has also been uti-
patients through the use of new technology. lized in the administration of medications,
However, the introduction of new technically where every medication has a barcode that is
advanced equipment also comes with added or scanned in conjunction with a barcode for the
different risks. For example, there is currently patient who is to receive the medication. This
concern about the adequate cleaning of endo- use was intended to eliminate medication errors
scopic retrograde cholangiopancreatography and has been very successful. However, none of
(ERCP) endoscopes, based on reports of a fatal these technological systems are infallible, with
drug-resistant pathogen and inadequate steriliza- common “workarounds,” which negate the
tion of these scopes [34]. Endoscopes are fre- purpose of the safety system [37]. Identification
quently utilized throughout the United States, of work-arounds to determine why current poli-
with an estimated 15,000 operations performed a cies and procedures fail to work is therefore an
year with contaminated ERCP scopes [35]. essential element of safety [38].
Ineffective cleaning and sterilization is more than
a personnel competency issue. Manufacturing
design of equipment has parts that are inaccessi- Supply Issues
ble for cleaning and allow for the retention of tis-
sue and other debris from the operation. If such The operating room contains a large quantity of
problems are attributed to personnel competency supplies, stock, and instruments needed to per-
issues, they are often related to not following the form the surgical procedures. However, there are
standardized or recommended procedure for several issues with surgical supplies that are
cleaning the equipment. Furthermore, developing challenging. One of the largest supply issues is
an ongoing system for assessing technical com- the use of the wrong implant or equipment dur-
petency of invasive procures using rehearsal and ing the procedure [39]. Procedures are delayed if
warm up is valuable [36]. the correct supplies are not available, or if a sur-
Many procedures have been standardized, gical instrument is dropped or is missing from
and other technology is utilized to minimize the the surgical pack. Such problems can potentially
potential for errors to occur. The use of elec- cause harm to the patient [40]. Another issue is
tronic health records (EHR) has increased the that in some cases the supplies being utilized are
standardization of documentation, including expired, a situation in violation of the Food and
order sets for patient conditions and treatment. Drug Administration requirement that all drugs
The EHR has provided an electronic intercon- and medical materials administered to humans
nectedness among practitioners who can now be used within their expiration date [41].
readily review the documentation of other prac- Another issue is the use of counterfeit medical
titioners. However, as the recent MedStar data- supplies. The Veterans Administration (VA)
hacking event suggests, there are inherent received counterfeit surgical devices and supplies
when they started utilizing reverse auctions Table 33.7 Issues addressed by the perioperative gov-
erning council
where sellers compete to provide goods or ser-
vices at the lowest price to fulfill their contracts Add-on classification
[42]. This resulted in unauthorized distributers Behavior issues
utilizing counterfeit supplies, some of which may Block scheduling
have been stolen from other hospitals. These Capital requests
products may not have been stored at proper tem- Care coordination with physician offices
peratures, maintained in appropriate packaging, Credentialing in difficult areas such as robotics
and so forth. Expensive implants
On-time starts
Quality oversight and reporting
Staffing, workforce issues
Governance
Surgical products and vendors
Throughput
Reducing risks in the perioperative environment
Time-outs
requires management and leadership from hospital
administration, surgeons, and anesthesiologists.
An effective way of providing structure for this and type of healthcare organization is a very
goal is to establish a perioperative governing coun- important variable in the topic of scope of practice
cil comprised of leaders from all three areas. The issues. Each of the care settings may have differ-
goals of the council are to build trust among the ent types of procedures and different types of
medical staff, keep physicians abreast of periopera- practitioners on their surgical rosters. The settings
tive initiatives, identify opportunities to increase where the surgical procedures are conducted will
physician satisfaction and ease of practice, and have different support services available, depend-
support initiatives to improve the efficiency and ing upon the particular type of healthcare organi-
effectiveness of the operating room. The governing zation. Thus, an acute care hospital is capable of
council should establish a set of bylaws and written performing more complex surgeries than an
policies and procedures dealing with the kinds of ambulatory surgery center while the ambulatory
perioperative issues listed in Table 33.7. surgery center is capable of performing more
In many institutions, other committees such as complex procedures than a physician’s office.
a surgical executive committee, an operations
committee, and a quality committee complement
the governing council. Surgeons, nurses, anesthe- Credentialing and Privileging
siologists, and administrators are represented on
each of these committees so that all points of Every team member must have his/her creden-
view are represented and communication with tials verified at the time of employment and on
peers and other staff is optimized. an ongoing basis. For Licensed Independent
Practitioners (LIPs), which includes physicians,
advanced practice nurses, physician assistants,
Scope of Practice Issues and dentists, the credentialing is completed at
the time of initial hiring/approval to work at an
The surgical team must work together with trust organization. Recredentialing normally occurs
and good communication skills to ensure that all every 2 years. The LIP may also be granted
the team members are competent within their additional privileges that are based on the prac-
roles and are willing to speak up when something titioner’s education and experience with the
is wrong or suboptimal. An important part of this privilege. The criteria to grant privileges are
trust is the competency of each practitioner and determined by the medical staff, and there are
team member, which must be established by the many guidelines developed by medical profes-
organization where they are practicing. The size sional organizations that can be used to identify
the required competency. An example is the use at a facility and not just a general robotic
Guidelines for Laparoscopic Ventral Hernia proficiency. The surgeon must also have the
Repair, established by the Society of American ability to intervene if something goes wrong
Gastrointestinal and Endoscopic Surgeons with the robot during the procedure. In 2013,
(SAGES) in 2014 [43]. At the time of reappoint- the FDA conducted a survey of physicians who
ment, the practitioner must produce evidence of utilize robotic systems, examining the prob-
having performed a minimum number of ventral lems encountered with using these devices [46].
hernia repairs over the past 2 years without Among their findings was a patient whose colon
harm to patients. was punctured during prostate surgery with the
Professionals make errors, but a pattern or da Vinci robot, a robotic arm that would not let
trend of errors may indicate an unsafe practitio- go of tissue grasped during colorectal surgery,
ner, an issue that must be examined at the time of and one woman who was hit in the face by the
reappointment. If a LIP currently on staff wishes robot during a hysterectomy. Alemzadeh, Iyer,
to add a new privilege, the LIP must demonstrate Kalbarczyk, Leveson, and Raman reported in
the education and experience level determined by 2015 the results of a retrospective study of 14
the medical staff before the LIP is awarded the years of FDA data. The authors examined
privilege. For example, when bariatric surgery 10,624 robotic system adverse events and found
was first introduced, physicians were asked to that over 8061 events (75.9 %) were caused by
take didactic and clinical courses to learn how to device malfunctions [47].
perform the procedure. The medical staff deter- The lawsuits resulting from these types of
mines the number of cases the practitioner has to errors have found the surgeon liable for some of
perform and whether or not proctoring by a senior the errors. It is therefore important for the cre-
practitioner is required before the privilege will dentialing committee and medical staff at all
be awarded to the practitioner. facilities using robotics to carefully determine
Robotic surgery is a major technological the requirements for an individual to receive
advancement. As one might imagine, this tech- robotic privileges. Privileges may be granted for
nology represents a complicated piece of specific procedures rather than across the board,
machinery and there is a risk of malfunction and many institutions have established a robotic
during the procedure as well as several unin- committee to oversee robotic practices and the
tended consequences. The da Vinci Surgical credentialing process.
System was approved for use by the FDA in Once a LIP is granted clinical privileges, the
2000, and was rapidly adopted and widely used list of those privileges should be sent to the surgi-
in hospitals within a few years [44]. In this sys- cal department and to the schedulers who post the
tem, the surgeon controls the robotic arms cases. Ideally, both the surgical department and
while sitting at a computer console. Although the schedulers should be checking the privilege
the robotic system enhances flexibility, preci- list of all practitioners who schedule a procedure
sion, and control during the procedure, the sys- to ensure that the practitioner has privileges to
tem is not without its inherent problems and perform the procedure. If the LIP does not have
issues. For surgeons to have clinical privileges privileges, the case should not be scheduled and
to use the robotic system, they must have spe- the practitioner notified of the reason.
cific training with the use of the particular sys-
tem and model [45]. The different units
available for robotic surgery are controlled in
different ways by robotic arms working from a Staff Competency
predetermined program to the point of com-
plete control of the robotic instruments by the When members of the surgical team are first
surgeon. The surgeon must have education and employed by the healthcare organization, they go
experience with the type of robotic system in through an orientation period which includes a
competency checklist. The skills on the compe- critical for the surgical team. If the surgical team
tency checklist are determined by the individual’s does not communicate well with one another, a
role on the surgical team. For example, the circu- medical error is more likely to occur [51].
lating nurse does not have to possess the skills of Situational awareness refers to an individual’s
the surgical technician assisting the physician, ability to maintain attention and to be able to
unless that nurse may also assist the physician in respond to changes in the environment and
a role similar to the technician. The timeframe for changes in a patient’s condition [52]. This aware-
this orientation varies based on the type of facil- ness may in some cases require the individual to
ity and the types of procedures performed, as speak up or stop the line and prevent the proce-
well as the experience level of the team member. dure from continuing [53]. As the surgical team
goes about their job during a procedure, they are
concentrating on what they are doing and may
Association of periOperative become less aware of what is actually happening
Registered Nurses in the room around them. It is at these times that
a sponge can be left in the patient or the proce-
The Association of periOperative Registered dure can be initiated at the wrong site. All team
Nurses (AORN) has established various practices members must be able and willing to speak up
for the nurses within the surgical environment, and stop the procedure to prevent an error from
Guidelines for Perioperative Practice [48]. This occurring [54]. It is critical that the culture of the
document contains revised and new evidence- organization support this type of communication
based guidelines for perioperative nurses and and team approach to surgical procedures.
other team members in an effort to standardize
practice and promote patient and worker safety.
The AORN has also developed a Perioperative Surgical Setting
Patient Focused Model to be utilized in surgical
settings to help RNs document and describe peri- The healthcare physical setting where the surgi-
operative patient care [49]. This model puts the cal procedure is performed also has a high
patient at the center of the framework with all impact on the scope of practice of the surgical
practice designed to meet the needs of the patient team [32, 55]. Many of the outpatient service
and family. The model, similar to the clinical sites, other than an outpatient surgery center, for
microsystem model [50], is an outcomes-driven example, do not have the capability to perform
model focusing on perioperative nursing prac- advanced life support on patients in extremis.
tices as they relate to patient outcomes. The There is not always a crash cart with emergency
model has four domains: safety, physiologic supplies present in many office settings used for
responses, behavioral responses (family and indi- surgical procedures. The only way to get assis-
vidual), and health system. The first three tance is to dial 911 and perform cardiopulmo-
domains are patient focused and the last domain, nary resuscitation (CPR) until the paramedics
health system, refers to administrative, opera- arrive with emergency equipment. The surgical
tional, and structural data. The model addresses team members in an outpatient facility may not
74 nursing diagnoses, 153 nursing interventions, have experience and training with rare, but
and 38 nurse-sensitive patient outcomes. potentially fatal events, and they could lack sup-
port personnel. Additionally, office-based sur-
gery, such as cosmetic surgery, is often performed
Nontechnical Skills under monitored anesthesia or conscious seda-
tion care, which is different than general anes-
Nontechnical skills such as situational aware- thesia [56] and requires careful planning for safe
ness and effective interpersonal relationships are and reliable sedation [56].
In 2010, almost 70 % of all cosmetic surgery Table 33.8 Emergency equipment for sedation and
analgesia
was performed in doctors’ offices [57]. A con-
cern in performing office surgery is the lack of Appropriate emergency equipment should be available
whenever sedative or analgesic drugs capable of
regulatory oversight. Office-based procedures,
causing cardiorespiratory depression are administered.
such as liposuction, have been found to be sever- The lists below should be used as a guide, which
alfold more risky than when done in hospital set- should be modified depending on the individual
ting [58]. The facility must be accredited by the practice circumstances. Items in brackets are
recommended when infants or children are sedated
American Association for Accreditation of
Intravenous equipment
Ambulatory Surgery Facilities, the Accreditation
Gloves
Association for Ambulatory Health Care, the
Tourniquets
Joint Commission on Accreditation of Healthcare
Alcohol wipes
Organizations, a state-recognized entity such as
Sterile gauze pads
the Institute for Medical Quality, or Medicare
Intravenous catheters (24–22 gauge)
certified under Title XVIII.
Intravenous tubing [pediatric “microdrip” (60 drops/
ml)]
Intravenous fluid
Equipment Assorted needles for drug aspiration, intramuscular
injection (intraosseous bone marrow needle)
The facility should be outfitted with the appropri- Appropriately sized syringes (1-ml syringes)
ate medical equipment, materials, and drugs nec- Tape
essary to provide anesthesia, recovery Basic airway management equipment
ministration, cardiopulmonary resuscitation, and Source of compressed oxygen (tank with regulator
provisions for potential emergencies. or pipeline supply with flowmeter)
Furthermore, the operating facility should have Source of suction
the basic patient safety devices, such as “humidi- Suction catheters (pediatric suction catheters)
Yankauer-type suction
fiers, oximeters, capnography, warming blankets,
Face masks (infant/child)
and pneumatic/compression leg garments.” It
Self-inflating breathing bag-valve set (pediatric)
must also have appropriate “fire-fighting equip-
Oral and nasal airways (infant/child sized)
ment, signage, emergency power capabilities,
Lubricant
and lighting.” All operative equipment should be
Advanced airway management equipment (for
inspected, maintained, and tested on a regular practitioners with intubation skills)
basis as recommended by the manufacturer. Laryngeal mask airways (pediatric)
The personnel, equipment, and procedures must Laryngoscope handles (tested)
be adequate to handle potential medical and other Laryngoscope blades (pediatric)
emergencies [59]. Table 33.8 lists emergency Endotracheal tubes
equipment for sedation and analgesia Cuffed 6.0, 7.0, 8.0 mm ID (Uncuffed 2.5, 3.0, 3.5,
recommended by the American Society of
4.0, 4.5, 5.0, 5.5, 6.0 mm ID) stylet (appropriately
Anesthesiologists [56, 60]. sized for endotracheal tubes)
In some cases, there is a limit to the amount of Pharmacologic antagonists
equipment and support services available, and Naloxone
most likely no anesthesiologist is available to Flumazenil
provide assistance if needed. In these cases, the Emergency medications
Epinephrine
surgical team must be extra vigilant to ensure that
Ephedrine
the equipment is working properly and that there
Vasopressin
are backup supplies and surgical instruments.
Atropine
The entire surgical team must be well prepared
Nitroglycerin (tablets or spray)
for any situation that may arise during or after the
(continued)
procedure.
Table 33.8 (continued) the error. In his article, Dr. Wu sets forth the
Amiodarone basic elements of the second victim scenario,
Lidocaine ranging from the unduly high expectation of the
Glucose, 50 % (10 or 25 %) physician to the reaction of peers about the
Diphenhydramine feelings of the practitioner:
Hydrocortisone, methylprednisolone, or … technological wonders, the apparent precision
dexamethasone of laboratory tests, and innovations that present
Diazepam or midazolam tangible images of illness have in fact created an
From the American Society of Anesthesiologists’ expectation of perfection. Patients, who have an
“Practice Guidelines for Sedation and Analgesia by Non- understandable need to consider their doctors
Anesthesiologists” (Anesthesiology 96: 1004, 2002) infallible, have colluded with doctors to deny the
existence of error. Hospitals react to every error as
an anomaly, for which the solution is to ferret out
Another practice issue is the use of equip- and blame an individual, with a promise that ‘it
will never happen again.’
ment and implants that have not been approved
by the FDA for the intended use. The Code of Paradoxically, this approach has diverted
Federal Regulations (CFR) Title 21 Parts 800– attention from the kind of systematic improve-
898 establishes approved uses for all devices, ments that could bring a more systems aware-
drugs, nutrition, and biologicals. The law states ness and help to decrease harm [64]. Many errors
that FDA-approved equipment is not to be uti- are built into existing routines and devices, set-
lized for non-approved use [61]. Utilizing ting up the unwitting physician and patient for
approved devices for unapproved use can result disaster. Although patients are the first and obvi-
in harm to the patient and/or others in the surgi- ous victims of medical mistakes, doctors are
cal area [62]. In a transplant hospital that is part wounded by the same errors—they are the sec-
of a seven-hospital system, a female patient went ond victims [65].
to surgery to receive a kidney transplant from a Wu elaborates by noting that there are no for-
family member. The donor suffered a massive mal mechanisms for providing support to the
hemorrhage that resulted in her death. This sen- provider for the emotional impact of serious
tinel event was investigated with a root cause patient harm. In many instances the physician
analysis, and it was discovered that the FDA did feels guilty and technically incompetent. These
not approve a clamp that was used in the surgery. feelings are then combined with the fear of dis-
The clamp was not the cause of the bleeding, but covery, all of which can lead to an atypical reac-
because the facility was not in FDA compliance, tion to the family, ranging from being overly
they were found at fault for the death. attentive to distress over disclosure [66].
Scott in 2009 applied a consensus definition
developed by the University of Missouri Health
The Second Victim Care (UMHC) in a study performed by their
Office of Clinical Effectiveness (OCE) [67]:
This chapter would not be complete without Second victims are healthcare providers who are
addressing the role of error disclosure and the involved in an unanticipated adverse patient event,
second victim of a medical mistake or untoward in a medical error and/or a patient-related injury
outcome not caused by a mistake—the practi- and become victimized in the sense that the pro-
vider is traumatized by the event. Frequently, these
tioner. In the year 2000, Dr. Albert Wu wrote individuals feel personally responsible for the
about a difficult period during his residency, patient outcome. Many feel as though they have
when a resident’s failure to diagnose led not failed the patient, second guessing their clinical
only to the patient’s deterioration, but also to skills and knowledge base.
condemnation by his peers [63]. Dr. Wu The following case studies serve to illustrate
described this resident as the second victim of and expand the concept of the second victim.
Case #1: The Almost Event On their website, K.U. Leuven Second Victims

in Health Care summarizes the impact as fol-
The telephone rings in the cabin in Central lows [68]:
Texas at 2 a.m. Sunday. Answering it, I hear a
female who cannot talk above a whisper. “Are • The healthcare professional can experience a
you the risk manager?” “Yes,” I reply, thinking professional impact, such as:
that she must not work for our main hospital or –– Different attitude within the team
she would know that. “I’m Sally Field, a nurse –– Insecure feeling in the presence of the team
at Disney Hospital, a newly affiliated hospital. I –– Different attitude in the presence of patients
almost took the wrong patient to surgery” and their families
“Almost? Did the wrong patient have surgery?” –– Uncertainty, which elevates the chance in
“Oh no, it was caught by the nurse in holding.” making other mistakes
“That’s good, isn’t it?” “Yes, it is but I’m so –– Burnout
upset. So embarrassed. Now people will know • The healthcare professional can also experi-
what I did.” The nurse is not new to the job, she ence a personal impact, such as:
is not inexperienced, and she knows the proce- –– Post-traumatic stress
dures. So why did she call? She is worried that –– General stress symptoms
it will happen again. She is mortified. We debrief –– Anger
the event. The patients had similar names and –– Insomnia
were on the same floor. She is used to doing her –– Nervousness
tasks without any aids—no notes, nothing to –– Effect on family life
assist her memory—but at age 55 she finds that –– Depression
her system isn’t working anymore. Being that
age myself, we discuss simple tools such as a
small spiral pad for n ote-taking. The procedures Case #2: The Angry Physician
worked properly and tomorrow we will debrief
again to see if any steps done on the unit could A physician is angry. Really angry. Yelling at me
have prevented this near miss. angry. Standing in the hallway smoking a cigarette,
In the UMHC study, six stages were identified absolutely livid. The physician review committee
that occur in response to a serious mistake [67]. has considered a surgical case that may possibly
These stages included: become a claim and found her care appropriate.
The physician feels totally blindsided—that the
• Chaos and accident response review was a whitewash. A highly respected physi-
• Intrusive reflections cian, she believes the committee failed to note
• Restoring personal integrity treatment options that could have led to a different
• Enduring the inquisition outcome out of deference to her. This person is a
• Obtaining emotional first aid detail-oriented practitioner. She is, like many phy-
• Moving on sicians, someone who came to medicine through
science. She doesn’t want to repeat the event. She
The sixth stage, moving on, led to one of doesn’t want to defend an indefensible case. Most
three outcomes: dropping out, surviving, or of all, she wants to know why this happened. That’s
thriving. At the time of the event, the physician what science teaches—if you do this, that will hap-
may be having two types of thoughts: how to pen. If this, then that. If we cannot assist her to
care for the patient combined with an immediate determine why the case had a poor outcome, she is
reaction to the event as an error. In many cases doomed to repeat it, and this is her biggest fear.
clinicians are able to describe almost complete One liability review chairman taught that we
recall of the event, which could be triggered by have all killed a patient. We have all faced this
outside stimuli, with continual self-questioning. awful experience. But what did we learn? How
did we handle it? How may we help our fellow cians, this means a referral to EAP; however, many
physicians in the future? Another liability review physicians refuse to go and turn to their peers.
chairman taught that no one comes to work to They meet with the liability review committee
hurt a patient. Everyone wants to leave work with chairman. For this reason a provider support group
a smile on his face, jangling his keys, happy may be needed to provide counseling, support, and
about the day. But what happened? And even in some cases mentoring and proctoring.
more important: If we can determine what hap- Just as organizations face risk on a daily
pened, we can establish a routine to prevent it. basis, the day-to-day life of a healthcare practi-
tioner also involves risk. Virtually all activities
of a physician involve risk. An unexpected out-
ase # 3: A Different Type
C come produces personal and professional fears
of Impairment for the practitioner and legal, regulatory, and
reputation fears for both the practitioner and the
A physician appears in the office and sits down. institution. How the institution supports the
“I think I killed that woman.” A physician practitioner sets the stage for an environment of
appears in the office and sits down. “I think I trust and is a signal to other practitioners about
misdiagnosed that child.” A physician appears in the true culture of the institution.
the office and sits down. “I missed an abnormal Fear of litigation is as paralyzing as the fear of
lab.” A physician appears in the office and sits repeating the (possible) mistake or damaging
down. “I operated on the wrong side. What do I one’s reputation. The laws and regulations under
tell the patient? How do I meet the family? How the Patient Safety and Quality Improvement Act
do I go back to work? How do I face my peers?” of 2005 established the creation of Patient Safety
Practitioners in these situations call the risk Organizations (PSOs) that should allow for a
manager for help. Certainly, many call because the patient safety review process without fear of legal
risk manager is the liaison to their malpractice discovery [69].
company or because they were mandated to call. Several elements are essential in providing
Others call because it is the route to an unbiased support for the second victim:
peer review process. Some will not call the risk
manager and will only call a peer. A common con- • The physician often wishes a formal peer review
cern is whether they can return to practice. Some of the event in order to determine the adequacy
physicians called to report but could not come to of the care rendered to the patient and ways of
the office. Their voices spoke of fear and stress. preventing the type of event in the future.
Risk management requires neutrality. Rule • The physician often requires personal support
number one for the risk manager—be fair. from a peer, through formal or informal chan-
Physicians, nurses, and allied health practitio- nels. Note this is not a onetime meeting but
ners—anyone who could cause harm—called the ongoing as the clinician travels through vari-
office and were offered a chance to tell their story ous emotional stages of grief.
and to be informed about the procedures. For • The physician may request a monitoring
many, the risk management office is a safe place period for support and feedback during simi-
to report an event and hear the worst. For others, lar circumstances.
it carries potential censure. • The physician may wish to or be directed to
Physicians often express gratitude that some- meet with the patient and family for purposes
one else shared their burden, would point the way, of disclosure.
would provide and arrange support, and would
help them return to practice. Nevertheless, risk There is tension between the fact-finding inves-
management is not the employee assistance pro- tigative mission, the legal defense considerations,
gram (EAP). For nursing this can mean a referral and the physician support teams. The trajectory of
to an established nursing support team. For physi- these three paths requires a clear policy and
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Managing the Complex High-Risk
Surgical Patient 34
Kevin W. Lobdell, B. Todd Heniford,
and Juan A. Sanchez
“Risk comes from not knowing what you’re doing.”

—Warren Buffett-Business Magnate and Investor
of a coin, in which the potential outcomes and

Risk and Risk Registries probability are known. In contradistinction to a
coin flip, the uncertainty of surgical risk does not
Risk, hazards or threats that an outcome might be allow us to know all possible outcomes or the
different than expected, implies that choice rather probability of occurrence of each outcome.
than fate is involved. The word risk is thought to The evolution of risk, and risk management
have evolved from Italian, circa 1600s, where programs parallels progress in mathematics. It is
“risicare” meant “to dare” has evolved to suggest noteworthy that developments in mathematics
that, in accepting risk in the hope of a favorable related to risk include Pascal and Fermat’s theory
outcome, a different result may occur. Risk has of probability in 1654 resulting from a challenge
various modern definitions that include, but are to divide the stakes of an unfinished game
not limited to: (1) the possibility of injury or loss; between two players when one player was ahead.
(2) a person or thing that creates a hazard; and (3) By 1725, mathematicians devised life expectancy
the financial chances of loss, whether in insurance tables for the English government which became
or investing. Additionally, to risk is to (1) expose the genesis for annuities. Bernoulli described the
injury or loss, and (2) incur the danger of injury or “Law of Large Numbers” in 1703 and subse-
loss. A practical example of risk would be the flip quent, noteworthy concepts were developed by
de Moivre, who described the Law of Averages in
1730, Galton who related Regression to the Mean
in 1875, and Markowitz who advanced the con-
K.W. Lobdell, MD (*) cept of “diversification” in 1952.
Sanger Heart and Vascular Institute, The computer era has accelerated data manage-
PO Box 32861, Charlotte, NC 28232, USA
ment, analysis, and risk-modeling. Governments,
military, and financial institutions utilize informa-
B.T. Heniford, MD
Department of Surgery, Carolinas Medical Center,
tion technology advancements to communicate,
1025 Morehead Medical Center Suite 300, Charlotte, optimize efficiency, and improve the efficacy of
NC 28204, USA resource allocation, all central to mitigating risk.
e-mail: [email protected] Similarly, data has accumulated in healthcare lead-
J.A. Sanchez, MD, MPA ing to the development of modeling techniques
Department of Surgery, Ascension Saint Agnes and simulation models, allowing comparison of
Hospital, Armstrong Institute for Patient Safety &
Quality, Johns Hopkins University School of Medicine,
process compliance, death, complications, length
Baltimore, MD 21229, USA of stay, readmissions, and cost per case for various
e-mail: [email protected] procedures and maladies.

590 K.W. Lobdell et al.
The Society of Thoracic Surgeons National mated to be 0.4 % and morbidity 3–17 % [3–11].
Cardiac Database (STS-NCD) and its risk models, Surgical and anesthesia perioperative complica-
first established in 1989, is the archetype of a risk- tions can be categorized as local/specific or gen-
adjusted clinical registry [1]. Similarly, the eral either by providers or by patients [12].
American College of Surgeons has developed the Temporal categorization of outcomes can be
National Surgical Quality Improvement Program early, intermediate, and late. The rate of compli-
(NSQIP) and aims to improve quality in breast dis- cations correlates well to clinical risk. For exam-
ease, cancer, pediatric surgery, trauma, as well as ple, the NSQIP analysis of over 105,000 patients
via a surgeon specific reporting (SSR) program suggests that the occurrence of any one of the 22
[2]. Additionally, the United States’ Medicare pro- complications reduced the median life expectancy
gram has developed Hospital Compare (https:// by 69 % [13]. This risk of death and morbidity is
www.medicare.gov/hospitalcompare/search.html) always borne by the patient; however, other par-
with the aim of allowing the program’s subscribers ticipants in the healthcare system (surgeon, facil-
and the general public to compare the quality and ity, and payer) bear other types of risks including
value of health care delivery institutions. reputational, regulatory, and financial [14].
The “volume-to-value” evolution in health- Although statistical models for death and com-
care with its inherent reward and granular defini- plications are useful, the statistician George E. P.
tions of quality is generally expected to result in Box reminds us that “all models are wrong, some
improved measures of clinical and financial out- are useful.” The American College of Surgeons
come as well as enhanced level of patient satis- National Surgical Quality Improvement Program
faction. Domains of quality and value in calculator (available at https://www.facs.org/qual-
healthcare converge in Medicare’s Value-Based ity-programs/acs-nsqip) is one example of an
Purchasing program. Proprietary datasets, such accessible, simple to use, and validated surgery
as Premier, Truven, US News & World Report, risk assessment tool that applies to numerous pro-
utilize administrative data and their own method- cedures and can assist the patient’s and clinician’s
ologies to rate health care facilities. Although decision making (https://www.facs.org/quality-
this plethora of information should assist indi- programs/acs-nsqip/about/businesscase).
viduals, employers, and payers to make wiser Computerized risk models have also been vali-
informed choices, the result is confusing and dated by comparing results with experienced sur-
unhelpful to many consumers of healthcare as a geons [15]. Risk scoring systems can be used as a
result of major differences between these sources snapshot of a patient’s risk at a point in time prior
of information and their analyses. As such, the to operative intervention or be more dynamic
natural evolution of efforts to derive actionable where the risks evolve with a patient’s clinical
information with regard to clinical risk resides in course in general or organ specific terms, associ-
programs, such as NSQIP and STS. These types ated with specific phases of care (e.g., periopera-
of registries provide for concurrent data abstrac- tive or critical care phase). Table 34.1 shows
tion by clinicians as well as transparent, continu- examples of surgical risk models which can be
ously adjusted risk models to assess disease or specialty-specific (http://www.riskpre-
patient-specific risk as well as meaningful com- diction.org.uk/; http://riskcalc.sts.org/stswebrisk-
parisons of clinical outcomes between providers. calc/#/; http://www.euroscore.org/) [16–22].
Risk-model characteristics include, but are not
limited to, calibration-observed and expected rate
High-Risk Surgery of agreement, discrimination-ability to separate
high and low risk or those that have event or dis-
The Global Burden of Surgery (GBS) comprises ease from those that do not, accuracy, precision,
11–28 % of the Global Burden of Disease (GBD) etc. [19] (http://riskcalc.sts.org/stswebriskcalc/#/).
and the worldwide estimate is 234 million opera- High-risk surgery (HRS) is generally defined
tions per year. Overall surgical mortality is esti- as mortality greater than two standard deviations
34 Managing the Complex High-Risk Surgical Patient 591
Table 34.1 Surgical and organ dysfunction risk models Table 34.2 Examples of low, intermediate, and high-risk
[16–22] procedures
Acute physiology and chronic health evaluation High risk Open aortic and major vascular,
(APACHE) urgent intra-thoracic, or intra-
American society of anesthesia (ASA) abdominal surgery
Charlson co-morbidity index (CCI) Intermediate Elective abdominal, carotid,
risk endovascular, major neurosurgical
EuroScore 1 and 2
procedures, arthroplasty,
Lee revised cardiac risk (RCRI) pulmonary resections, and major
Mortality probability model (MPM) urological operations
Multiple organ dysfunction score (MODS) Low risk Breast, dental, thyroid, ophthalmic,
Physiologic and operative severity score for the plastic, and minor gynecologic,
enumeration of mortality and morbidity (POSSUM, orthopedic, and urologic surgery
P-POSSUM)
Sequential organ failure assessment (SOFA)
Simplified acute physiology score (SAPS) vice, teamwork and communication, long term
Society of thoracic surgeons (STS-NCD) morbidity, patient report of morbidity (PROM),
Surgical risk outcome tool (SORT) etc. Additionally, cost-containment measures
Vascular study group cardiac risk index (VSG-CRI) such as lengths of stay, readmissions, cost per
case, for example, are increasingly used mea-
sures to gauge the effectiveness and value of care.
from the mean mortality for a procedure as deter- Numerous investigations have evaluated and cor-
mined by analyses using accurate, statistically related risk with cost (http://www.ahic.nihi.ca/
acceptable datasets [23]. Similarly, a projected ahic/docs/IBV%20Study%20Redefining%20
mortality over 5 % may be defined as high risk the%20Value%20of%20Healthcare.pdf) [24–26].
and greater than 20 % very high risk. The physi- Studies have linked lower quality and complica-
ologic assessment of risk is an increasingly use- tions with additional costs [27]. For example,
ful method of risk analysis including anaerobic Dimick et al. evaluated the economic impact of
threshold quantification, functional capacity and complications in high-risk surgical procedures
frailty, and biomarkers (e.g., BNP for heart fail- (935 hepatic and esophageal operations) [28].
ure or TIMP-2 and IGFBP-7 for acute kidney The observed mortality was 6.1 %, while 38.4 %
injury). Examples of procedures with different patients had complications, and the median cost
levels of risk are shown in Table 34.2. increase for patients with complications was
31 % when compared to patients with no compli-
cations. Acute renal failure (ARF) was associated
Economics of High-Risk Surgery with an incremental increase in cost of $25,219,
septicemia $18,852, and myocardial infarction
In the USA, health care consumes approximately $9573. Because of variation in the incidence of
18 % of the Gross Domestic Product (http://data. complications, the attributable fraction of total
worldbank.org/indicator/SH.XPD.TOTL.ZS). resource costs was highest in ARF (19 %), septi-
Global waste in healthcare is estimated to be cemia (16 %), and surgical complications (16 %).
$4.27 trillion annually, making it the least effi- Speir and colleagues report from the Virginia
cient and unsustainable system in the world. This Cardiac Surgery Quality Initiative (VCSQI) ele-
staggering inefficiency, with questionable effi- gantly quantified the additive costs of complica-
cacy in many areas, impedes meaningful impact tions associated with 14,780 coronary artery
and progress in relieving the Global Burden of bypass operations between 2004 and 2007 [29].
Disease (GBD). Surgical care has evolved from a These costs ranged from $62,773 for mediastini-
focus on technical proficiency in anesthetic and tis (240 % greater costs than without this
procedural refinement, to a “360°” view that complication), $49,128 with renal failure,

includes patient and family perceptions of ser- $40,704 with prolonged ventilation, $34,144
with postoperative stroke, $20,000 for reopera- increased metabolic rate, oxygen consumption,
tion for hemorrhage, and $2744 (10.3 %) for and muscle loss [41]. Many researchers have fur-
atrial fibrillation. The average length of stay ther elucidated and characterized the physiology
(LOS) of 7.4 days was also significantly impacted of the stress response to include neuroendocrine
costs and ranged from 37.8 days for mediastinitis changes, catabolic degradation of muscle pro-
to 9.6 days for isolated atrial fibrillation. teins, the release of a multitude of inflammatory
Additional large cardiac surgery studies have mediators, alteration in intravascular, intracellu-
also demonstrated a strong correlation between lar, and extracellular fluids (commonly described
poor quality and increased cost [30–32]. as “third-spacing”), coagulopathy, etc. [42].
Birkmeyer and colleagues found that federal Modulation of the stress response has been
payments for kidney transplantation to low-quality intensely investigated with the aim of mitigating
centers exceed that of high-quality centers [33]. A the associated risks. Common examples include
2012 investigation demonstrated that centers in the anabolic agents such as growth hormone and tes-
highest quintile for complications versus the low- tosterone and anti-catabolic agents such as amino
est quintile required greater cost payments for acids like glutamine, arginine, and branched
coronary artery bypass surgery ($5353), colec- chain amino acids [43]. Beta-blockade has been
tomy ($2719), abdominal aortic aneurysm repair demonstrated to reverse the catabolic effects of
($5279), and hip replacement ($2436) [34]. The burns [40] and has also been studied in various
utility of incorporating risk models in determining conditions demonstrating a reduction in mortality
provider reimbursement for a variety of alternative and cardiovascular morbidity [44, 45]. A better
payment models is often the source of contentious understanding is needed about the manifold
and bipartisan debate [35]. effects of these commonly utilized agents as well
as the more recent additions to our pharmaco-
logic armamentarium such as lipid lowering
Host Risk Factors agents [46]. Neuraxial anesthesia, deep opioid
anesthesia, peri-procedural sedation, and other
A systematic and disciplined approach to mitigat- anesthetic techniques have also been proposed to
ing modifiable risk across the health system is the reduce risk and improve outcomes due to their
goal of risk management systems [36]. Each mitigating effects on the stress response [47, 48].
patient’s evaluation should include a history,
physical exam, review of medical records, appro-
priate testing and specialty consultation as indi- Thermoregulation
cated, and all available information used in the
assessment of specific risks [37, 38]. A keen Thermoregulation is commonly disturbed as a
understanding of the response to injury and surgi- result of low ambient temperatures in the operat-
cal trauma is fundamental to caring for surgical ing room as well as the effects of anesthesia.
patients especially in high-risk patients and proce- Thermoregulation is important in maintaining
dures [39]. Risk is increased in high-physiologic hemostasis by reducing coagulopathy and the
demand procedures, low physiologic reserve amount of surgical blood loss, thereby avoiding
patients, and when a mismatch occurs between the risk of blood transfusions and products.
the physiologic demand and the patient’s reserves. Hypothermia is associated with lower metabolic
Cardiopulmonary exercise testing (CPET) can rates, immunologic changes that increase the risk
provide valuable insight into a patient’s reserve of surgical site infections, delays in recovery, and
but is not commonly utilized due to patient limita- separation from mechanical ventilation [49–51].
tions, resource utilization, and the inability to The incidence of hypothermia can be reduced
consistently predict outcomes [40]. with accurate temperature measurement and
Cuthbertson is credited with early insights assiduous attention to ambient room temperature,
into the “stress response” characterized by fever, patient draping, warming intravenous solutions
and blood products, warming ventilator circuits, non-bariatric general surgical patients using the
and the use of warming blankets. NSQIP database and observed that BMI’s influ-
ence on mortality exhibited a reverse J-shaped
relationship, with the highest rate of death in
Age underweight and extremely morbidly obese
patients while the overweight and moderately
Age is an independent risk factor for poor out- obese had the lowest mortality rates [54]. These
comes and knowledge of age-specific risks creates observations are in contrast to mortality in the
an opportunity to anticipate and mitigate these “general medical” population in which obesity
risks (https://www.facs.org/~/media/files/qual- reduces longevity, hence the “paradox." The
ity%20programs/geriatric/acs%20nsqip%20geri- study also demonstrated a direct correlation
atric%202016%20guidelines.ashx). Postoperative between BMI and complications particularly sur-
delirium is an example of a frequent, insidious gical site infections (SSI). The authors also dem-
complication which is observed in 30–50 % of onstrated that obesity is not a risk factor for
patients after major surgery and as high as 75 % postoperative mortality or major complications
in patients over age of 70. It is commonly seen in after major intra-abdominal cancer surgery while
the older age group and is associated with short underweight patients experienced a fivefold
and long term increased mortality, morbidity, increased risk of postoperative mortality [55].
and LOS. Mitigation strategies include vigilant Ramsey and Martin have suggested that elevated
monitoring, careful analgesia, vision and hear- BMI increases operative complexity in pancre-
ing aids, mobility, quiet and reassuring surround- atectomy but that the increased risks associated
ings, and an active effort to maintain circadian with BMI may be reduced with modifications in
day–night schedules where possible. Adding a techniques and meticulous perioperative care
clock to patient’s rooms has been shown to [56]. Underweight and extremely high BMI
reduce delirium and confusion. Jung determined patients experience greater risk while mild obe-
that the incidence of delirium in frail cardiac sur- sity wasn’t found to be a risk factor for 30-day
gery patients was 3–8-fold higher [52]. outcomes after vascular surgery and actually
Additionally, increased risks in the elderly appeared to confer an advantage [57]. Studies
include falls, infection, and pulmonary compli- examining the influence of BMI on spine surgery
cations accounting for 40 % of postoperative outcomes have produced mixed results. There
complications and 20 % of potentially prevent- appears to be an increased risk in high BMI
able deaths [53]. patients undergoing revision spine surgery but
not cervical fusion [58, 59]. Cardiac surgery
patients are similarly impacted by weight, where
Mass and BMI low BMI and extremely high BMI confer an
increased risk. Although an increased BMI may
Lower than normal body mass index (BMI) con- adversely alter some recovery processes while
sistently confers a surgical risk, while overweight simultaneously reducing hemorrhage and trans-
patients may have an increase in wound compli- fusions [60]. Stamou demonstrated that over-
cations and deep venous thrombosis. These weight cardiac surgery patients have lower
patients, however, are not at increased risks of operative mortality and a better 5-year survival
death and other major complications. In fact, than patients with a normal BMI supporting the
some higher and BMI patient populations appear “obesity paradox” phenomenon [61]. Johnson
to exhibit fewer perioperative complications, et al. corroborated these findings in 78,762 car-
operative mortality, and better long term survival. diac surgery patients where overweight and
This phenomenon is often referred to as the “obe- mildly obese patients had better outcomes than
sity paradox.” Mullen et al. reviewed 118,707 the underweight and the morbidly obese did [62].
Neurologic System ment which takes into consideration age, oxy-

gen saturation, and other clinical factors as well
A history of a stroke, seizure, movement disorders, as the location of the surgical incision, the dura-
and other neurological conditions confer addition of surgery among other elements [74].
tional risks and can adversely affect outcomes in ARISCAT categorizes risk as follows: 0–25
surgical patients. The ability to assess pain accu- points low risk and is associated with a 1.6 %
rately is important in providing patient comfort, pulmonary complication rate, 26–44 points
preventing immobility and atelectasis. Several intermediate risk, and a 13.3 % pulmonary com-
useful pain scoring systems may be u tilized [63– plication rate, while 45–123 points suggests
65]. The use of neuraxial and opioid anesthesia has high risk and is associated with a 42.1 % pulmo-
been shown to reduce operative mortality by 30 % nary complication rate (http://www.uptodate.
in a meta-analysis comparing neuraxial blockade com/contents/calculator-ariscat-canet-preoperative-
with general anesthesia [47, 48]. pulmonary-risk-index?source=search_result&s
earch=risk+calculator&selectedTitle=7~150).
Mechanical ventilation can be a contributory
Pulmonary System factor in the development of postoperative acute
lung injury and acute respiratory distress syn-
A history or evidence of chronic respiratory drome (ARDS) [76]. It is associated with
insufficiency or other respiratory conditions can mechanical ventilation, inspired oxygen fraction,
impact perioperative care and elevate operative the administration of crystalloid volume intrave-
risks [66]. It is essential that we develop and nously, as well as transfusion of homologous
agree on common definitions across different dis- blood components [77]. In contradistinction to
ciplines treating the patient [67]. Spirometry and pulmonary barotrauma in which pulmonary dam-
formal pulmonary function testing, arterial blood age is the result of excessive airway pressures,
gases, and chest radiography should be obtained the mechanism of injury from volutrauma is
in the evaluation of these high-risk patients par- likely to over distention of alveoli from excessive
ticularly in patients undergoing thoracic and excessively high tidal volume settings and injury
abdominal procedures. Smoking cessation 30 to the alveoli epithelium. Early extubation after
days prior to operation is strongly recommended surgery, particularly in patients with pre-existing
and is often coupled with counseling and nicotine lung disease, may reduce the incidence of both
replacement; however, smoking cessation of barotrauma and volutrauma and has been corre-
seven or less days can actually increase pulmo- lated with improved outcomes [78, 79].
nary secretions and pulmonary complications Intraoperative alveolar recruitment using PEEP,
[68, 69]. Pulmonary rehabilitation appears to be maintenance of tidal volumes of 6–7 ml/kg, and
beneficial in reducing pulmonary risk although postoperative utilization of non-invasive positive
its impact needs more intensive study [70–72]. pressure ventilation are protective ventilator
Postoperative respiratory complications strategies known to reduce the incidence of post-
occur in approximately 3–6 % of surgical operative respiratory complications [80, 81].
patients and most risk models commonly Hypercapnia is another lung protective strategy
include respiratory data such as active smoker that has been proven meritorious [82, 83].
status, chronic obstructive pulmonary disease, In thoracic surgery, dependent, bedridden
dyspnea, and active pneumonia. In addition, living correlates with 7–8-fold increased risk of
assessing functional status, ASA class, renal mortality, nine fold prolonged ventilation rate,
insufficiency, and other cardiopulmonary condi- and three fold more likely to require reintuba-
tions are important elements of a comprehensive tion [84]. The predicted postoperative lung
evaluation in patients undergoing major surgery function after lung resection is typically greater
[73–76]. As an example, ARISCAT provides than what is witnessed clinically by at least
preoperative pulmonary-specific risk assess- 30 % and is most disparate on the first postop-
erative day with subsequent progressive The Vascular Study Group of New England
improvement [85, 86]. (VSGNE) studied the vascular surgery popula-
The Thoracoscore, a convenient and useful tion’s risk of adverse cardiac events and has
risk scoring system in thoracic surgery, was the developed the Vascular Study Group Cardiac
result of an in-depth analysis of 15,183 thoracic Risk Index (VSG-CRI) [17]. Additional investi-
surgery patients where in-hospital mortality gations utilizing the American College of
correlated with ASA classification, age, gender, Surgeons’ NSQIP database reinforces the impor-
dyspnea score, performance status, priority of tance of surgery type, ASA classification, func-
surgery, diagnosis group, procedure class, and tional status, age, as well as renal dysfunction
comorbid disease. Modifiable risk factors to [92]. CAC score improves preoperative assess-
reduce the risk of complications include weight ment and is able to assign patients to various risk
loss, smoking cessation, and a multidisciplinary categories in order to modify processes and care
approach towards optimizing lung functions plans accordingly [93].
including exercise, patient education, as well as The impact of drugs to mitigate cardiovascu-
the treatment of bronchorrhea and broncho- lar risk has been well-studied, albeit controver-
spasm [87, 88]. sial, and continues to evolve. For example, the
PeriOperative ISchemic Evaluation (POISE)
trial evaluated metoprolol in patients at increased
Cardiovascular System risk for perioperative cardiovascular events
(death, myocardial infarction, and nonfatal car-
The preoperative evaluation of the high-risk diac arrest) [94]. While significantly fewer car-
patient with cardiovascular disease should focus diovascular events were noted in the treatment
on assessing the risk of perioperative myocardial group, metoprolol was associated with an
ischemia and infarction and the identification of increased risk of death and stroke potentially
significant cerebrovascular disease, congestive related to the observed perioperative hypoten-
heart failure and ventricular dysfunction, rhythm sion. Clonidine has also demonstrated similar
abnormalities, and pulmonary hypertension [89]. hypotensive effects and nonfatal cardiac arrest
Lab testing may include biomarkers such as BNP. and failed to reduce the risk of death or myocar-
Treadmill exercise testing is readily available and dial infarction [95]. Aspirin has been shown to
well-studied [90]. Additional imaging can include have no beneficial impact on a composite mea-
many variations of echocardiography, nuclear sure which includes death and myocardial infarc-
testing, computerized axial tomography, coro- tion and increases the risk of bleeding [96].
nary artery calcium (CAC) score, magnetic reso- Combinations of these strategies have been
nance imaging (MRI), and coronary angiography reported including the use of neuraxial blocks
with or without ventriculography and, more with general anesthesia which wasn’t associated
recently, fractional flow reserve-FFR, as with an increase in adverse cardiovascular out-
indicated. comes in the POISE-2 study [97].
In 1977, Goldman developed the eponymous Valvular heart disease is increasingly recog-
cardiac risk scoring systems for patients under- nized in our aging patient population. The effects
going non-cardiac surgery which was revised by of volume loading on left ventricular function
Lee et al. (RCRI) in 1999 making it simpler and occurring in mitral regurgitation as well as the
more predictive [91]. The risk factors are tallied pressure load in aortic stenosis, particularly in the
and are correlated with the risk of major cardiac setting of depressed myocardial contractility,
complications. Zero risk factors has a 0.4 % risk carry considerable risk. These conditions must be
of death, 1.0 % with one risk factor, 2.4 % with recognized during the preoperative evaluation and
two risk factors, three or more risk factors carry a anesthetic as well as surgical techniques modified
risk of 5.4 % [16]. to optimize outcomes [98]. Atrial fibrillation
Table 34.3 Stroke risk using the CHA2DS2-VASc score Splanchnic System
0 points 0.2 % per year
1 point 0.6 % per year The history and physical exam should be focused
2 points 2.2 % per year (looking for jaundice, signs of portosystemic
3 points 3.2 % per year shunting, ascites, encephalopathy, etc.) to eluci-
4 points 4.8 % per year date liver dysfunction as well as altered bowel
5 points 7.2 % per year and pancreatic dysfunction. A patient with
6 points 9.7 % per year advanced hepatic cirrhosis is simple to identify,
7 points 11.2 % per year but less pronounced degrees and other hepatic
8 points 10.8 % per year disorders may be overlooked with considerable
9 points 12.2 % per year consequence(s). It is vital to elucidate the amount
and limits of the functional reserve. Timing of
operation and avoiding hepatic insults (pharma-
commonly accompanies valvular heart disease cologic and hemodynamic) are central to suc-
although non-valvular atrial fibrillation (AF) is cessful anesthesia and perioperative care.
more common. Regardless of its underlying cause The Model for End-Stage Liver Disease
AF can affect cardiac performance especially (MELD) is clinically valuable and relevant, cate-
with a poorly controlled heart rate and pose gorizing patients via bilirubin, creatinine,
thromboembolic risk. The CHA2DS2-VASc International Normalized Ratio (INR), and the
(Congestive heart failure, Hypertension, Age >75, etiology of underlying liver dysfunction [101].
Diabetes, prior Stroke/transient ischemic attack, MELD scoring has also been compared favorably
VAScular disease) risk stratification score for esti- with others systems, such as the Child-Turcotte-
mating stroke risk in non-valvular AF ranges from Pugh classification [102]. Common problems in
0 to 9 points as shown in Table 34.3 (http://www. patients with liver dysfunction include coagulop-
uptodate.com/contents/calculator-cha2ds2-vasc- athy 2–28 % and hemorrhage, immuno-
risk-stratification-score-for-estimation-of-stroke- incompetence and sepsis 9–58 %, malnutrition,
risk-for-nonvalvular-atrial-fibrillation?source= cardiomyopathy with systolic dysfunction and/or
search_result&search=risk+calculator&selectedT diastolic dysfunction, and peripheral vasodila-
itle=5~150). Appropriate perioperative anticoag- tion, pulmonary dysfunction 6–29 %, and renal
ulation strategies can mitigate the risk of atrial dysfunction 5–79 % [103].
fibrillation associated emboli. Liver dysfunction increases mortality of
Aortic surgery and other major vascular pro- patients undergoing cardiac surgery, where coag-
cedures are frequently associated with a high ulopathy and hemorrhage are commonplace, and
risk for adverse cardiac events and mortality. progressively increases with the severity of liver
Investigation of this subset of patients highlights dysfunction. The MELD score has proven useful
importance of ASA class, age, and preoperative for risk assessment and planning in the cardiac
organ dysfunction as essential elements of risk surgery population [104]. Liver resection also
assessment and mitigation strategies [99]. In poses a discrete and identifiable risk to patients
patients undergoing left ventricular assist device with liver dysfunction. Four independent risk
(LVAD) implantation postoperative right ven- predictors include ASA class, aspartate amino-
tricular dysfunction can be a vexing problem. A transferase level, extent of liver resection (>3 vs
right ventricular failure risk score (RVFRS) has <3 segments), and the need for an additional
been developed which attributes points to preop- hepaticojejunostomy or colon resection [105].
erative vasopressor requirements as well as to Intestinal and pancreatic exocrine deficiency
elevated serum levels of aspartate aminotrans- may emanate from a variety of diseases, have a
ferase, bilirubin, and creatinine to predict the myriad of signs and symptoms, but the greatest
need for postoperative inhaled nitric oxide, ino- functional risk relates to malnutrition.
tropic support, and mechanical support of the Gastrointestinal, colon, and rectal surgery are
right heart [100]. common procedures, where ASA class, age,
BMI, prolonged and open procedures (vs. laparo- mortality and longer LOS and these risks are
scopic techniques), active smoking, chronic documented extensively in adult cardiac surgery
obstructive pulmonary disease (COPD), kidney [114–118]. Various risk models have been devel-
dysfunction, corticosteroid use, and sepsis have oped and commonly include age, BMI, hyperten-
been correlated with increased risk [106]. sion, peripheral vascular disease, chronic
Pancreaticoduodenectomy is a high-risk proce- pulmonary disease, serum creatinine concentra-
dure and significant predictors of morbidity tion, anemia, previous cardiac surgery, emer-
include functional status, increased age, obesity, gency operation, and operation type [119–121]
COPD, kidney disease, corticosteroid use, hypo- (http://riskcalc.sts.org/stswebriskcalc/#/calcu-
albuminemia, hemorrhagic diathesis, and leuko- late). AKI risk mitigation strategies include
cytosis. Significant predictors of 30-day mortality avoidance of nephrotoxic drugs—e.g., aminogly-
included COPD, hypertension, neoadjuvant radi- cosides, amphotericin B, and ionic contrast.
ation therapy, elevated serum creatinine, and Pretreatment with sodium bicarbonate and
hypoalbuminemia [107]. fenoldopam haven’t stood the test of time. Delay
Perioperative bowel prep regimens can be after ionic contrast administration appears impor-
beneficial with recent studies suggesting that tant, though many details remain to be under-
mechanical bowel prep should be accompanied stood. More recently, high-chloride intravenous
with oral antibiotics in colon and rectal surgery to fluids are thought to be associated with a signifi-
reduce the risk of surgical site infections, anasto- cantly higher risk of acute kidney injury [122].
motic leak, and ileus. The use of mechanical Goal directed therapy (GDT), also known as
bowel prep and oral antibiotics may also reduce goal directed hemodynamic management, is well
length of stay and readmissions [108–110]. The studied and maintains considerable promise as a
use of H2-blockers and proton pump inhibitors modifiable risk in AKI and renal failure [123–
can markedly reduce the risk of stress induced 125]. A prospective study is underway to further
gastrointestinal hemorrhage, but may increase define the utility of this strategy [126].
the risk of hospital acquired pneumonia [111].
Endocrine System
Renal System
The targeted history and physical should elucidate
The targeted history and physical, searching of risks which include thyroid dysfunction, adrenal
renal dysfunction is commonly accompanied by insufficiency, and pancreatic endocrine abnormali-
urinalysis, serum creatinine, and calculation of ties, most commonly diabetes mellitus, which also
glomerular filtration rate. Imaging is less com- adds considerable, additional risk. Considerable
monly utilized than for cardiac and pulmonary controversy exists, despite extensive research, in
evaluations, but ultrasonography, radiography, the management and risk mitigation of periopera-
and endoscopy may be useful in certain tive hyperglycemia. Hyperglycemia is linked with
circumstances. death, surgical site infection, and atrial fibrillation
Perioperative renal dysfunction is common in the cardiac surgery patient and various proto-
and often unrecognized [112]. Patients may suf- cols have been developed to provide glycemic
fer various degrees of acute kidney injury (AKI), control [127].
without the need for dialysis, and incur increase
short and long term risk. Ableha et al. reported on
1597 patients and found ASA classification, Skin and Wounds
emergency and high-risk surgery, age, ischemic
and congestive heart disease, and RCRI score The history and physical must elucidate risks
significant predictors for the development of (malnutrition, vitamin, and trace mineral defi-
AKI, in patients needing intensive care after sur- ciency central to wound healing, diabetes melli-
gery [113]. AKI is linked with increased risk of tus, immunosuppression, infection, peripheral
occlusive vascular disease, immobility, genetic wounds more comfortable for patients, and accel-
defects, radiation therapy and chemotherapy, erates wound healing. The archetype for this
smoking, etc.) which can impair recovery, either growing use and experience is the infected ster-
through development of problems such as pres- nal wound, where topical negative pressure is
sure sores/ulcers or non-healing wounds. Tests commonly thought to be superior to traditional
such as ankle-brachial indices, transcutaneous methods of irrigation and packing [128, 129].
oxygen saturations, and quantitative wound cul- “Wound vacs” are also commonly utilized to
tures may augment expert evaluation and deci- assist in preventing wound infections associated
sion making. with delayed sternal closure.
Proper planning, positioning, and padding are
imperative during operative procedures to pre-
vent pressure sores. Considerable investigation Metabolism and Nutrition
has been devoted to wound closure and includes
type of suture, monofilament vs. braided, perma- The comprehensive history and physical will
nent vs. absorbable, skin closure with sutures and include special attention to metabolic and nutri-
staples, and a multitude of dressings. In cardiac tional signs and symptoms that increase the risk of
surgery, various techniques for sternal closure recovery. Wound healing may be impaired with
after median sternotomy have been investigated various metabolic maladies and commonly with
and the role of “rigid sternal fixation” to prevent malnutrition—where attention should focus on
dehiscence and/or infection is currently unre- weight loss, loss of muscle and subcutaneous fat,
solved. Skin cleansing, wound closure, and sup- and edema. Laboratory tests to be considered
port have been vigorously marketed, but evidence include electrolytes, BUN, Cr, etc. Markers of pro-
for value is scarce. A complete review of adjuncts, tein status (albumin, transferrin, and pre-albumin)
such as wound healing factors and hyperbaric may be valuable in select patients. Malnutrition
oxygen, is beyond the scope of this text. can increase the risk of infection related to impair-
Comprehensive, postoperative care will include ment of cellular and humoral immunity, poor
attention to skin, dressings, mobility, nutrition, etc., wound healing, pressure ulcers, etc. Nutritional
in order to reduce the risk of pressure sores and intervention has been shown to be valuable in vari-
wound problems. Skin can be assessed in combina- ous areas. Enteral, parenteral, and targeted reple-
tion with the Braden Scale, with special attention to tion of vitamins and trace metals have been studied
sensory perception, moisture, activity, mobility, and should be considered when appropriate to
nutrition, and friction or shear. Glucose control is mitigate surgical and perioperative risk [130, 131].
thought to be important in preventing sternal
wound infections after sternotomy and various
other surgical site infections as well. Wound evalu- Hematologic and Immune System
ation should also be included in the comprehen-
sive, postoperative routine (http://www.uptodate. The history and physical must elucidate risks
com/contents/calculator-p ressure-ulcer-risk- associated with anemia, coagulopathy, infec-
stratification-braden-score?source=search_result& tions, and related factors that would suggest
search=risk+calculator&selectedTitle=8~150130; increased risk of intraoperative and postoperative
http://www.uptodate.com/contents/wound- problems. Anemia is commonly associated with
healing-and-risk-factors-for-non-healing?source= surgical patients and will often lead to increased
search_result&search=wound+closure&selectedTi use of blood products although with unclear ben-
tle=9~95). efits. In fact, according to the STS-NCD in 2014,
Negative pressure wound therapy has a long 43.2 % of coronary artery surgery patients
history, is well studied, and commonly utilized. received blood transfusions. Much has been writ-
The use of “wound vacs” has simplified wound ten about the considerable, negative impact
care, makes management of open and infected (death and complications as well as cost) of this
phenomenon. Consideration should be given to the risk associated with blood product transfusion.
preoperative diagnosis and correction of anemia Acquired coagulopathy is increasing with the use of
with iron, vitamin B12, folate supplementation, various anticoagulants for atrial fibrillation, coro-
or administration of recombinant human erythro- nary and cerebrovascular disease, as well as side
poietin [132]. Investigations continue to refine effects of nontraditional medical remedies. The
our understanding of the risks of anemia and HAS-BLED bleeding risk score is useful and
transfusion and aim to optimize our management includes age, liver dysfunction, renal dysfunction,
of these common and vexing issues [133]. bleeding tendency, warfarin and antiplatelet drug
Coagulopathy is important, albeit less com- use, and alcohol excess [136]. The risk is tallied
monly recognized than anemia. Hypercoagulable with 0–9 points and bleeds range from 1.13 per 100
states can lead to deep venous thrombosis (DVT), patient-years to 8.7 bleeds per 100 patient-years
which has a lower clinically recognized incidence with four points, with greater than or equal to three
than when imaging is routinely utilized for screen- points suggesting high risk. Insufficient data for 5–9
ing. DVT is associated with pulmonary thrombo- points precludes forecasting, but the risk remains
embolism, which is low incidence, but potentially high (http://www.uptodate.com/contents/calculator
catastrophic. The DVT Geneva risk scoring sys- -clinical-characteristics-comprising-the-has-bled-
tem suggests the following risks: heart failure, bleeding-risk-score?source=search_result&search=
respiratory failure, stroke, MI, infection, rheu- risk+calculator&selectedTitle=10~150; http://
matic disease, cancer or myeloproliferative disor- www.uptodate.com/contents/perioperative-
der, nephrotic syndrome, prior thromboembolic management-of-patients-receiving-anticoagulants?
disorder, hypercoagulable state, immobility, travel, source=search_result&search=perioperative+antic
age, increased BMI, venous insufficiency, preg- oagulation&selectedTitle=1~150).
nancy, hormonal therapy, and dehydration. Points A complete review of pharmacologic agents
attributed to the presence of each risk correlate that impair coagulation is beyond the scope of
with incidence: 0–2 lower risk—0.8 % 30-day risk this text, but the clinician should be familiar with
of symptomatic VTE or VTE-related mortality, characteristics of common drugs, including half-
3–30 points higher risk—3.5 % 30-day risk of life of effect, bridging and reversal strategies, etc.
VTE or VTE-related mortality (http://www.upto- This includes warfarin, direct thrombin inhibi-
date.com/contents/calculator-geneva-risk-score- tors, antiplatelet agents, and also the use of antifi-
for-venous-thromboembolism-in-hospitalized- brinolytics which are valuable and recommended
medical-patients?source=search_result&search=ri in cardiac surgery guidelines and also in trauma
sk+calculator&selectedTitle=6~150). Caprini has patients at high risk of hemorrhagic shock [137].
investigated postoperative venous thromboembo- Immunologic disorders may contribute to sur-
lism and also categorized patient’s risk with 20 gical risk. Clinicians should seek relevant infor-
variables: low (0–1, 34.5 %), moderate (2–4, mation about congenital and acquired immune
48.5 %), or high-risk (more than 4, 17.2 %) catego- deficiencies and mitigate risks as they associate
ries. DVT prophylaxis wasn’t utilized as com- with perioperative infections (and also wound
monly as guidelines would recommend and healing).
mechanical prophylaxis with sequential compres-
sion devices was utilized more frequently than
chemoprophylaxis [126, 134–135]. Non-host Factors
Hemorrhagic diathesis is less common than ane-
mia and DVT. Hemophilia and platelet disorders Surgeon Factors
must be elucidated and an appropriate plan for safe
intraoperative management and postoperative care Karamichalis et al. and Nathan et al. have exten-
coordinated with a hematologist and anesthesiolo- sively investigated the operative phase of care in
gist. Increasingly, genetically engineered coagula- congenital cardiac surgery and developed a technical
tion factors and concentrates are available, limiting performance score. The final technical performance
score has the strongest association with patient out- The Michigan Keystone Project collaboration
comes [138–143]. Additional work with this techni- targeted the critically ill, where Pronovost et al.
cal performance concept should be developed in demonstrated decreased catheter related blood-
other technical, high-risk procedures to identify risk, stream surgical infections (CLABSI) by 66 %
learn, improve, and mitigate risk [143]. [154, 155]. Others like Dixon-Woods have demon-
strated greatly reduced benefits of CLABSI efforts
when clinicians are not actively championing and
Team Factors privy to all change efforts [156]. Additional inves-
tigation in this area is aimed at understanding how
Growing evidence from TeamSTEPPS and other to sustain the gains achieved and diffuse them
training programs suggest that surgical teams across other clinical units [157]. More recent, US
that train together, develop surgical leadership government sponsored efforts include Hospital
skills, and use briefing and debriefing can pro- Engagement Networks (HEN) and the Partnership
duce better outcomes [144, 145]. Neily et al. for Patients (PfP) (https://innovation.cms.gov/
reviewed 182,409 surgical cases from 108 VHA Files/reports/PFPEvalProgRpt.pdf.). Both HEN
facilities, using the VHA Surgical Quality and PfP have demonstrated success in reducing
Improvement Program (VASQIP) in years 2006– some complications and cost savings although
2008, and showed that briefings and debriefings some question remains whether this approach
in the operating room, surgical checklists and actually improves care on the whole [158].
quarterly coaching interviews, led to a remark- Geographic regionalization efforts in high risk,
able 18 % reduction in mortality compared with low incidence procedures such as head and neck
the year before and with non-training sites [146]. surgery, cancer surgery, and pediatric cardiac
Furthermore, observation and feedback to surgi- surgery are noteworthy [159–161]. In Maryland,
cal teams of effective teamwork in the operating mortality from pancreaticoduodenectomy, LOS,
room can identify substantive deficiencies in the and costs all appeared to be favorably impacted
system and conduct of procedures, even in other- by regionalization [162, 163]. Birkmeyer et al.
wise successful operations, and lead to improve- have studied the impact of volume on quality
ments in surgical team performance [147]. and suggest that in the USA, operative mortal-
ity with high-risk surgery has decreased [164].
Furthermore, market concentration increased and
ollaboratives and Quality
C hospital volume have contributed to declining
Improvement Programs mortality with some high-risk cancer operations
(pancreatectomy, cystectomy, and esophagec-
Many efforts have improved the quality, safety, tomy), but mortality reduction with other proce-
and value of healthcare, thereby mitigating risk. dures (carotid endarterectomy, abdominal aortic
Cardiac surgery mortality was reduced by 24 % aneurysm repair, coronary artery bypass, and aor-
by the prototypical learning collaborative, the tic valve replacement) are largely attributable to
New England Cardiovascular collaborative, and other factors.
by 20 % in the Michigan surgical collaborative
[148, 149]. Stamou et al. pioneered the use of a
Quality Improvement Program (QIP) in cardiac Failure to Rescue
surgery and witnessed a 40 % reduction in mortal-
ity, improved morbidity and process compliance, “Failure to rescue” (FTR) from complications,
as well in leading key performance indicators another form of risk to patients, was endorsed by
such as early extubation [78, 79, 150–152]. Culig NQF as a core quality measure in 2012 and is
et al. utilized the Toyota Production System in a quantified for acute care facilities (https://www.
new program and found the risk-adjusted mortal- qualityforum.org/News_And_Resources/Press_
ity was 61 % less than expected and the cost per Releases/2012/NQF_Endorses_Surgical_
case was also decreased by $3497 [153]. Measures.aspx). The study of FTR has elucidated
a 2.5 fold difference, variation in institutional This finding reinforces the risk mitigation poten-
procedural mortality, and strong correlation with tial for centralization of high-risk procedures.
FTR (range 6.8–16.7 %) [165]. Ferraris et al. uti-
lized NSQIP data for nearly 2,000,000 patients
and found that 20 % of the high-risk patients Pharmacology
account for 90 % of FTR and two thirds of the
FTR patients had multiple complications [166]. The archetype risk prevention drug efficacy and
Elderly patients are at significant risk of FTR safety is aprotinin. While utilized for years in
from pulmonary and infectious complications cardiac surgery, and markedly reducing the risk
and differences are also witnessed between facili- of hemorrhage and transfusion, various studies
ties competence in rescuing the elderly [167]. ultimately led to discontinuation of its use [174].
Considerable variation in FTR rates appear to be Aprotinin has been linked with risk of myocardial
prominent in the highest risk patients, pointing to infarction, cardiac arrest, heart failure, renal dys-
the need to identify high-risk patients [168]. function, stroke, encephalopathy, and even long
Additional insight will accrue from the related term survival [175]. A complete review of the risks
pursuit of failure to arrest complications (FTAC), and benefits of various pharmacologic agents is
by not limiting our analyses to deaths, but impor- beyond the scope of this text, but each has a ther-
tant complications. apeutic index, small or wide, as well as favorable
Prager et al. demonstrated that the FTR rate in characteristics and various risks. Antibiotics are
cardiac surgery was significantly better in the low another example, having markedly reduced the
mortality facilities for the majority of complica- risk of various infections, but increased use and
tions (11 of 17) with the most significant findings abuse has led to the proliferation of drug resistant
for cardiac arrest, dialysis, prolonged ventilation, infections and maladies such as C. difficile colitis
and pneumonia. Furthermore, low mortality hos- and Carbapenem-Resistant-Enterobacteriaceae.
pitals are found to have lower FTR rates [169].
Novick et al. also investigated FTR in the cardiac
surgery population and found a 3.6 % mortality Blood Management
rate, complications in 16.8 % of patients, and
19.8 % FTR. FTR in patients with acute renal fail- Intraoperative transfusion of red blood cells and
ure was 48.4 % while septicemia was 42.6 %. other blood products increases the risk of mor-
They recommend that FTR should be monitored tality and several types of morbidities in surgi-
as a quality-of-care metric, in addition to mortal- cal patients [176]. This risk has been described
ity and complication rates, and utilized to identify in cancer surgery, cardiac surgery, and surgical
opportunities to improve quality and value [170]. critical care affecting both short and long term
FTR rates in lung surgery have also been found to outcomes [177]. An NSQIP database interroga-
be higher at high mortality hospitals [171]. tion related risk to a single unit appears after
adjustment for transfusion propensity [177].
Readmission Risk Factors

Systems of Care
A 10-year review of Medicare data, including
9,440,503 patients undergoing one of 12 major Peri-Surgical Home
operations determined that the readmission to the
index hospital was associated with 26 % lower Early patient and family engagement has been
90-day mortality than when a patient was read- utilized and incorporated into care for many
mitted to a non-index facility [172]. Additionally, years. For example, Ergina et al. believed in the
the effect was significant for all procedures, but merit of engagement and published the seminal
most pronounced for hospital readmissions after investigation on preoperative patients with COPD
pancreatectomy and aortobifemoral bypass [173]. [178]. They promoted appropriate perioperative
strategies to mitigate risk, which included smok- menting effective strategy, leveraging information
ing cessation, education, exercise training, and technology, and embedding other performance-
weight reduction. Jones et al. demonstrated the enhancing practices into the service delivery pro-
value of education in joint replacement via cess [186]. The evolving redesign of healthcare
improvement in LOS (without changing compli- delivery around service lines mirrors that of
cations) [179]. Additional studies at proactive “focus factories” (smaller number of offerings of
risk mitigation strategies include exercise and high-quality products) in other industries [187].
inspiratory muscle training [180–182]. Arora and This trend in value creation represents a migration
colleagues have investigated the positive merits away from “solution shops” (viz. traditional hos-
of combating the risk of frailty with 8 weeks of pitals) creating considerable opportunities to opti-
“prehabilitation” on 3 and 12 month outcomes mize quality improvement activities.
[183, 184].
More expansive programs include surgical
preparedness aimed at the continuum of care, or Process
the “surgical home,” and detailed pathways
developed to promote early recovery after sur- Various methods have been used to promote the
gery (ERAS). ERAS protocols have been devel- sharing mental of models, mitigating risk, and
oped for gastrectomy, cystectomy, colonic and improving patient care. Most noteworthy are goal
rectal surgery, and pancreaticoduodenectomy sheets, shown by Pronovost et al. to correlate
(http://www.erassociety.org/). ERAS protocols with improved communication of goals and
are proactive, including counseling, neuraxial resulting in shorter ICU LOS [188]. Gawande
anesthesia, avoidance of hypothermia, non- et al. have shown reduced mortality and morbid-
opioid oral analgesics, early mobilization, ity with checklist utilization [5, 189]. Patient
removal of urinary catheters, and challenge hand-off tools have been utilized and been shown
entrenched practices such as nasogastric tubes to reduce complications and readmissions to sur-
(See Chap. 23). The American Society of gical ICU’s and back to hospitals [173, 190] and
Anesthesiologists maintains standards, guide- Quality Function Development (QFD) has been
lines, and practice parameters for pre-anesthesia used to reduce waste and improved clinical sup-
care, post-anesthesia, and perioperative care port Managed Care Organizations [191].
(http://www.asahq.org/quality-and-practice- Multidisciplinary rounds have been shown to
management/standards-and-guidelines). engage the team providers and patients and may
mitigate the risk of death for critically ill patients
and provide value and efficacy, despite some
Organizational Structure inefficiency [192–194]. Organizational staffing
of critical care units with “closed” management
Porter suggested altering the traditional structure by dedicated critical care trained providers vs
of care into the integrated practice unit (IPU). The “open” model of non-critical trained providers
IPU is a dedicated team comprised of both clini- has been shown to reduce risk (lower mortality,
cal and nonclinical personnel providing the full morbidity, and LOS) [195], as have the use of
care cycle for the patient’s condition (https://hbr. tele-ICU technology [196, 197]. Similarly, oper-
org/2013/10/the-strategy-that-will-fix-h ealth- ational risk can be assessed and mitigated with
care). This model is similar to the clinical micro- the insight gathered from improved data manage-
system. Microsystems, based on work of ment and analysis paired with computer decision
intelligent enterprises by Quinn, apply systems support. For example, high acuity, an increased
thinking to organizational design and represent number of admissions, inexperienced teams, and
the smallest replicable organizational unit of staffing ratios can present various opportunities
change [185]. Microsystems are key to imple- for risk mitigation [198]. Weick and Sutcliffe
have studied complex industries and found that Conclusions

they share an extraordinary capacity to discover
and manage unexpected events resulting in The global burden of surgery, staggering costs,
exceptional safety and consistent levels of per- and inefficiencies coupled with an exponential
formance despite a fast-changing external envi- improvement in data management, analytics, and
ronment [199]. These high reliability decision support create an epic opportunity to
organizations (HROs) have characteristics that revolutionize healthcare. Systematic and meticu-
parallel many features of the surgical environ- lous risk assessment and mitigation of modifiable
ment, including the use of complex technologies, risks should be incorporated into all aspects of
a fast-paced tempo of operations, and a high level surgical care. Future risk assessment and mitiga-
of risk, yet they manifest spectacularly low error tion will certainly be built on a foundation of
rates [200]. improved bid data minding including data man-
Goal directed therapy (GDT) is a process agement, analytic capability, computer decision
where a variety of physiological goals and actions support, and the widespread utilization by
are utilized to mitigate risk in high-risk patients clinicians and insurers.
(e.g., trauma, sepsis, cardiac surgery, etc.) [201]. Parallel improvements in technology and
Shoemaker is commonly recognized as the inves- communication will burnish multidisciplinary
tigator who perceived the merit of GDT, studied teamwork and accelerate the transformation of
its use, and demonstrated its value [202, 203]. networked, decentralized surgical care. Wearable
While controversy persists around specific biosensors are evolving rapidly and will provide
parameters, goals, and associated therapeutic health care with data across the continuum. These
strategies, representative positive effects have biosensors and the “Internet of Things” will facil-
been demonstrated in femoral fractures and car- itate the development proactive strategies and
diac surgery [204, 205]. increasingly provide early warning systems to
Various other epidemiological modifiable mitigate risk. Parallel changes in the processes of
risk factors for processes of care have been care will also occur as will learning by clinicians
emerged such as late in day cardiac operations and compliance with protocols and pathways.
have been correlated with adverse outcomes IBM’s Watson is an example of massive data
[206]. The day of week may correlate with risk mining project aimed at harnessing healthcare
with 36 % increased mortality risk for non- data and revolutionizing healthcare data manage-
emergency, major operations on Friday to ment, analytics, and decision making (http://
Sunday vs. rest of the week [207] as well as the www.ibm.com/smarterplanet/us/en/ibmwatson/
month of year may affect patient outcomes watson-oncology.html).
[208] and weekend patient admissions of cervi-
cal spine fractures have worse outcomes than
those admitted on weekdays [209]. Outpatient References
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Geriatric Surgical Quality
and Wellness 35
Daniel J. Galante, JoAnn Coleman,
and Mark R. Katlic
“It’s a poor memory that only works backwards”

—White Queen to Alice; Lewis Carroll, 1980
what different from that in the general

Introduction population. This may lead to delay in
diagnosis.
The surgical treatment of the geriatric patient II. The elderly handle stress satisfactorily but
does not require special training, but rather car- handle severe stress poorly because of lack
ing for the older adult patient demands and man- of organ system reserve.
dates following six simple, and common sense, III. Optimal preoperative preparation is essen-
principles. While the Principles are quite basic, tial, because of Principle II. When prepara-
there are many aspects of geriatric care that they tion is suboptimal, the perioperative risk
affect, and failure to recognize their importance increases.
not only puts older patients at risk for preventable IV. The results of elective surgery in the elderly
harms but also does not provide these patients are excellent in some centers; the results of
with the highest quality of care possible. emergency surgery are poor though still bet-
First described by Katlic [1], the Principles are: ter than nonoperative treatment for most
conditions. The risk of emergency surgery
I. The clinical presentation of surgical prob- may be many times that of similar to elective
lems in the elderly may be subtle or some- surgery because of Principles II and III.
V. Scrupulous attention to detail intraopera-
tively and perioperatively yields great bene-
D.J. Galante, DO fit, as the elderly tolerate complications
Department of Surgery, Sinai Hospital of Baltimore,
2401 W. Belvedere Ave, Baltimore, MD 21215, USA
poorly (because of Principle II).
e-mail: [email protected] VI. A patient’s age should be treated as a scien-
J. Coleman, DNP, ACNP, AOCN
tific fact, not with prejudice. No particular
Sinai Center for Geriatric Surgery, Department of chronologic age, of itself, is a contraindica-
Surgery, Sinai Hospital, 2401 West Belvedere tion to operation (because of Principle IV).
Avenue, Baltimore, MD 21215, USA
The Principles concisely describe how older
M.R. Katlic, MD (*) surgical patients differ from their younger
Department of Surgery, Sinai Hospital,
2401 West Belvedere Avenue, Baltimore,
counterparts. Here we present ten common geri-
MD 21215, USA atric syndromes and relate them to the Principles.
e-mail: [email protected] While there are many more syndromes and

614 D.J. Galante et al.
p roblems that affect surgical patients, these are organ system reserve, and be unable to handle the
the most common, with the greatest incidence. severe physical stress of a major procedure or
Much like the Principles, the syndromes are not complication (Principle II). In order to counteract
singular problems. Rather, they typically occur in the effects of frailty on patients, preoperative
concert with each other. By relating them to the preparation, or “prehabilitation,” is a developing
Principles, the surgeon is provided with a com- field. This may allow patients to both reduce their
mon sense guide for caring for all patients, but in frailty, and thus their potential for complications
particular the older surgical patient. and adverse outcomes, and increase their system
reserves to counter severe stressors (Principle III).
Unfortunately, frailty, if not identified and
Frailty investigated, may not become apparent until it is
too late. Patients may tolerate elective procedures
Frailty is a syndrome that is associated with falls, due to compensation mechanisms and “prehabili-
increased risk for disability, and ultimately tation” programs, but when an emergency arises,
increased mortality. The work of Fried and col- the lack of reserve and preparation can leave
leagues has defined frailty as a syndrome with elderly patients at increased risk for complica-
multiple components and varying levels of sever- tions and adverse outcomes (Principle IV). In
ity. Unintentional weight loss, poor self-reported order for patients to appropriately handle compli-
endurance, decreased walking speed, and low lev- cations and major stressors, scrupulous attention
els of physical activity are included in the deter- to detail in the perioperative setting is required
mination of a patient’s degree of frailty. Patients (Principle V).
with at least three of the criteria are considered Ultimately, frailty is a factor that must be
“frail” and are considered to be at increased risk taken into account to provide the highest quality
for falls, decreasing/worsening mobility, ability to care to patients, regardless of their age (Principle
perform activities of daily living, hospitalization, VI). Some patients who are well above the elderly
and death. Patients with one or two of the frailty cutoff will fare far better than those many years
criteria are considered at “intermediate risk” and below.
were also at increased risk of becoming frail over
the next 3–4 years [2].
The “frailty phenotype” has been applied to Problems with Cognition
older patients around the world, with reproduc-
ible results. Frailty has been identified as an inde- As patients increase in age, their risk for develop-
pendent predictor of postoperative events, ing problems with cognition increases. Cognitive
increased length of stay, and likelihood of dis- impairment affects a large percentage of the popu-
charge to a skilled nursing or assisted-living lation, to a greater extent than dementia. The
facility. While frailty has been associated with Aging, Demographics, and Memory Study
worse outcomes following large surgical proce- (ADAMS) [4] reported that over 20 % of the pop-
dures to a greater extent than smaller ones, the ulation older than 71 years of age suffered from
fact remains that frail patients do not do as well some degree of cognitive impairment without
postoperatively. By identifying those patients dementia. The presence of preoperative cognitive
who are “frail” and “intermediate frail” or “pre- impairment is correlated with postoperative delir-
frail,” further work to decrease the level of frailty ium, which is further associated with poor surgi-
can be accomplished [3]. cal outcomes, longer length of stay, and increased
When examining frailty using the Principles, it risk for perioperative morbidity and mortality [4].
can be noted that the topic arises in all. A patient’s An easy method for assessing cognitive
frailty may mask or delay the clinical presentation impairment is the Mini-Cog assessment. This
of a condition (Principle I). Additionally, due to a simple assessment consists of providing three
frail state, elderly patients may have decreased words to remember, instructions to draw a clock
35 Geriatric Surgical Quality and Wellness 615
face with a set time, and repeating the three-item Table 35.1 Risk factors for delirium (modified from
optimal perioperative management of the geriatric surgi-
recall. Patients are scored on the number of cor-
cal patient, ACS NSQIP/AGS best practices guideline,
rect words recalled and the clock face. If all words 2016)
are recalled and the clock is normal, the patient
Preoperative risk Intraoperative and
receives five points. An abnormal clock scores factors postoperative risk factors
zero points and each recalled word scores one • Age greater than 65 • Infection
point. Zero to two points is indicative of impaired • Visual or hearing • Surgical stress
cognition and three to five points suggests there is impairment
no cognitive impairment [5]. It is recommended • Preexisting • Cardiopulmonary
that those patients whose scores are suggestive of cognitive complications
impairment
cognitive impairment be referred for evaluation
• Severe illness • Procedure complications
by a specialist. Studies have shown that abbrevi-
• Presence of • Inadequate pain control
ated testing, like drawing the clock face in the infection
Mini-Cog, are more effective at detecting demen- • Depression • Sleep deprivation
tia than other, more complicated tests. This speaks • Alcohol abuse • Hospital-acquired
to the ability of many patients to compensate and conditions
mask their symptoms, be they mental or physical • Current hip fracture • Medication toxicity/
(Principles I, II, III, V, VI) [6]. sensitivity
While this is just one method of assessing cog- • Renal insufficiency • New pressure ulcers
nition, there is no “best test” to be used. Other • Anemia • Malnutrition
validated tools are just as efficacious in the assess- • Poor nutrition • Use of physical restraints
ment of a patient’s cognition [7]. • Poor functional • Greater than 3 new
status medications added
Problems with postoperative delirium are also
• Limited mobility • Inappropriate medications
extremely common in the older surgical patient (per Beers Criteria)
and have been associated with increased morbid- • Unintentional • Indwelling bladder
ity. Defined as an acute decline in a patient’s cog- injury (falls) catheter
nitive function and attention, anywhere from 5 % • Polypharmacy
to 50 % of patients older than 65 will experience • Aortic procedures
postoperative delirium, with an estimated cost of • Frailty
$150 billion. The American Geriatrics Society
Expert Panel on Postoperative Delirium in Older
Adults, in its 2015 Best Practices Statement, to the prevention of delirium and maintenance of
gives evidence-based recommendations for both cognitive function [8].
the diagnosis and treatment of postoperative
delirium. While there are many risk factors for
postoperative delirium (Table 35.1) (6), ulti- Polypharmacy
mately having as few as two risk factors places a
patient at a significantly increased risk of devel- A complete medication reconciliation should be
oping postoperative delirium. completed for every patient undergoing a surgi-
In the treatment of delirium, the consensus of cal procedure, regardless of age. As patients age,
the AGS is that healthcare providers (physicians, the potential for medication interactions
nurses, therapists, etc.) be properly trained in the increases. In order for the surgeon to adequately
evaluation and diagnosis of delirium, in an effort prepare a patient for a surgical procedure, a full
to create multidisciplinary, multicomponent pro- list of medications, including over-the-counter
grams to combat delirium and increase cognitive and herbal supplements should be reviewed
function. Avoidance of polypharmacy and psy- (Principle V).
choactive medications, environmental modifica- The American Geriatrics Society and
tions, and rapid and consistent diagnosis is vital American College of Surgeons recommend all
nonessential medications that may increase sur- to both prevent falls and promote the completion
gical risk be discontinued prior to surgery, as of daily activities. Two studies showed that
well as medications that pose the potential to patients undergoing immediate cataract surgery
interact with anesthetics. Herbal medications experienced a lower rate of falls, compared to
should be stopped at least 7 days prior to any those undergoing delayed surgery. However,
procedure, due to the unstudied (or understud- other studies that included vision correction in
ied) nature of their interactions with anesthetics their programs experienced mixed results, includ-
and other medications administered in the peri- ing one study showing an increased risk of falling
operative period. with vision correction interventions. Ultimately,
The AGS/ACS also relies on the use of the vision problems should be formally addressed,
Beers Criteria for Potentially Inappropriate but the data supporting the various available
Medications to identify medications that may interventions is mixed [12].
cause issues in the perioperative period. The A thorough medication reconciliation and
Beers Criteria is the product of a systematic review should be performed to help eliminate
review that examines medication-related events medication-related fall risk. Elimination of cer-
and adverse reactions in the United States and tain classes of medications has been shown to
creates a list of medications to completely avoid have a significant effect on fall risk reduction.
in older adults, medications to avoid when Specifically, the removal of psychotropic medica-
patients have particular syndromes or disease tions from a patient’s regimen has been shown to
states, and medications to use with caution in have a positive effect on fall risk reduction.
older patients. New to the 2015 update, the Beers Additionally, if a medication cannot be com-
Criteria now also provide a list of drug-drug pletely eliminated, reduction in dose should be
interactions that are associated with medications considered.
other than anti-infectives, as well as non-anti-
infective medications that should be avoided or
dose reduced due to kidney function (creatinine Nutrition
clearance) [9].
Malnutrition is one of the most common conditions
to affect the older population [13]. A sad truth is
Decreased Mobility/Falls that a malnourished state may exist in an individual
for a significant period of time before physical
Approximately 30 % of the population over the manifestations appear. Despite the multitude of
age of 65 falls each year. Multiple studies have screening tools available to the clinician, the Mini
investigated different interventions to prevent Nutritional Assessment (MNA) was developed for
falls, particularly in the postoperative popula- assessing older patients and is the recommended
tion. The programs investigated with both home- assessment as part of the comprehensive geriatric
and group-based exercise programs, as well as assessment [13]. In a multinational retrospective
home safety interventions and modifications study of older patients, the MNA was able to iden-
aimed at decreasing falls. Guidelines from the tify that more than two-thirds of the 4507 patients
American and British Geriatric Societies recom- identified were either malnourished or at risk for
mend an exercise component fall prevention malnutrition. Additionally, the study showed that a
programs [10]. patient’s nutritional state declines as their need for
Whenever possible, environmental modifica- care increases [13].
tions should be performed as part of a fall risk The European Society for Parenteral and
assessment [11]. These modifications should be Enteral Nutrition (ESPEN), in their guideline
made to allow patients to safely perform their statement for enteral nutrition in geriatric
activities of daily living (Principles III and V). In patients, recommends a complete nutritional
addition, visual impairment should be addressed assessment of all geriatric patients. Additionally,
a nutritional plan should be developed that pro- ferring) and developing new deficits while hospi-
vides adequate supplementation of necessary talized. A study of 2293 patients, all 70 years and
nutrients. Generally speaking, patients require older, showed that 35 % of the cohort experienced
1 g/kg/day of protein and approximately 30 kcal/ a decline in functional status over the course of a
kg/day of energy (calories from carbohydrate and hospitalization. Of this group, 23 % failed to
fat) daily. Micronutrient deficiencies should be recover back to their baseline function [15].
supplemented appropriately, based on individual Patients who are at increased risk for functional
needs and deficiencies (Principles II, III) [14]. decline are those of advanced age, deemed “frail,”
Patients should be evaluated for their ability to suffering from cognitive impairment, of poor
tolerate oral intake. Some patients, while they can mobility or suffer a functional impairment, suffer
eat and drink, are at increased risk for aspiration. from depression, or suffer –from another “geriatric
Patients with coughing or choking, difficulty initiat- syndrome” (e.g., falls, pressure ulcers, malnutri-
ing swallowing, a globus sensation (perception of tion, etc.) (Principle II). Hospitals and extended
something being stuck in the throat), drooling or care facilities have implemented programs to help
inability to handle oral secretions, noted regurgita- prevent functional decline in older patients.
tion, or any other problem should be formally evalu- Special nursing and rehabilitation units have been
ated for their ability to take oral nutrition. Some developed particularly for older patients. The
older patients may be in a physical state that simply Nurses Improving Care of Health System Elders
does not permit adequate independent oral intake. (NICHE) program [16] has been developed to pro-
Current guidelines recommend against initiating vide tools that allow for specialized care of elderly
supplementary enteral nutrition via a nasogastric or patients. These tools help address specific prob-
gastrostomy tube purely due to financial or time- lems that affect the patient experience and patient
saving means. If enteral nutrition is appropriate for outcomes. Families are engaged to help prevent a
a patient, but they are unable to tolerate oral intake, further decline in function and ultimately help pro-
percutaneous access is superior to nasogastric feed- vide the best care possible to patients.
ing. In an analysis by the Cochrane group, it was As part of a geriatric preoperative evaluation,
shown that while enteral feeding and supplementa- determination of functional status is important.
tion (via any means) is superior regarding increas- This helps track, and prevent, a loss of function.
ing energy and nutritional intake, due to The Karnofsky performance score (KPS) is a 100-
formulations, taste alterations, and other side effects point scale that allows quantification of a patient’s
(nausea, diarrhea, cost), percutaneous feeding tubes functional status. The continuum spans from a
have greater compliance and tolerability [14]. score of 100 (totally independent, no care needs)
Ultimately, if a patient is competent to make to 0 (dead). In addition to grading a patient’s func-
their own medical decisions (see: goals of life/ tional status, the score is also helpful in identifying
care), there should be a thorough discussion those patients who are at risk of loss of functional
regarding nutritional status and how it affects the status (Principles I, II, III, V, VI) [17].
disease process, surgical treatment and healing, A similar scale that is used to evaluate a
and possible placement of a feeding tube. patient’s functional status has been developed by
the Eastern Cooperative Oncology Group
(ECOG). Used in many research trials, the ECOG
Function (Activities of Daily Living) score is a 0–5 scale that, similar to the Karnofsky
performance score, ranges from 0 (fully active, at
Patients are at an increased risk for decline in pre-disease performance status) to 5 (dead)
function and disability following a hospitaliza- (Table 35.2) [18]. Studies have shown that the
tion. Prospective data has shown that older two scores are similar in their utility, assessment,
patients are at risk for suffering both a decline in and prognosis [19]; however, the ECOG score
their ability to perform their activities of daily has been shown to better evaluate a patient’s gen-
living (dressing, eating, bathing, toileting, trans- eral prognosis [20].
Table 35.2 Comparison of ECOG and Karnofsky per- as a necessary discussion. Surgeons must incorpo-
formance status scores
rate the conversation into their preoperative plan-
Karnofsky performance ning, including not only the quantity of life desired
ECOG performance status status
but also the quality of life. This conversation
0—Fully active; able to 100—Normal, no
should include patients, as well as their families/
carry on all pre-disease complaints; no evidence
performance without of disease significant others. Conflicting opinions should be
restriction 90—Able to carry on discussed and reconciled (Principles IV and VI).
normal activity; minor There are many tools to help document these
signs or symptoms of
conversations, and some of these documents and
disease
tools are widely accepted across the country. In the
1—Restricted in physically 80—Normal activity
strenuous activity but with effort; some signs state of Maryland, the Maryland Orders for Life-
ambulatory and able to or symptoms of disease Sustaining Treatment (MOLST) is a variant of the
carry out work of a light or 70—Cares for self but Physician Orders for Life-Sustaining Treatment
sedentary nature, e.g., light unable to carry on
(POLST) [21]. These tools are not “Do Not
housework, office work normal activity or to do
active work Resuscitate” (DNR) forms, but rather they con-
2—Ambulatory and 60—Requires cisely state the extent to which medical providers
capable of all self-care but occasional assistance should attempt life-sustaining and resuscitating
unable to carry out any but is able to care for efforts. There is an element of choice in complet-
work activities; up and most of personal needs
about more than 50 % of 50—Requires
ing these orders, where the patient may select the
waking hours considerable assistance entire spectrum, from DNR to “full code” to any
and frequent medical combination of treatments in between.
care An additional tool that is widely used around
3—Capable of only limited 40—Disabled; requires the country is the “Five Wishes” living will tool
self-care; confined to bed special care and
or chair more than 50 % of assistance
kit. This document allows patients to clearly state
waking hours 30—Severely disabled; who is to make medical decisions for them in the
hospitalization is event the patient cannot, the types of medical
indicated although death treatments they want and do not want, the level of
not imminent
comfort they wish to maintain, how the patient
4—Completely disabled; 20—Very ill;
cannot carry on any hospitalization and wishes to be treated, and what the patient’s fam-
self-care; totally confined active supportive care ily is to be told or informed of. The ultimate goal
to bed or chair necessary of this tool is to remove any ambiguity or confu-
10—Moribund sion when a patient is unable to speak for him- or
5—Dead 0—Dead herself or found to be in extremis and requires
Reprinted with permission from Karnofsky D, Burchenal medical care.
J, the clinical evaluation of chemotherapeutic agents in
cancer. In: MacLeod C, ed. Evaluation of Chemotherapeutic
The ultimate goal of any of these tools is to
Agents. New York, NY: Columbia University Press; stimulate an honest and frank discussion between
1949:191–205 the physician, the patient, and the patient’s family
Zubrod C, et al. Appraisal of methods for the study of che- about the quality and quantity of remaining life
motherapy in man: comparative therapeutic trial of nitro-
gen mustard and thiophosphoramide. Journal of Chronic
desired. It is important for the physician to be
Diseases; 1960;11:7–33 honest with the patient and their family regarding
diagnosis and prognosis. It is acceptable for the
surgeon to recommend against a procedure.
Goals of Life/Care However, a patient’s age should not be the only
factor taken into account (Principle VI).
Components of surgical care of the older patient The utilization of vetted risk stratification
seldom discussed are goals of care and end-of-life tools, like the ACS/NSQIP risk calculator [22],
wishes. While many may feel that this is a morbid is helpful in removing subjective bias from the
topic to discuss, it is a topic that, post hoc, is seen conversation (Principles II, IV, VI). Once the
perceived risk that is associated with age is persons. The tool contains 30 questions that are
removed, and these tools are implemented, a true aimed at assessing a patient’s gestalt level of depres-
conversation can be held between the surgeon sion. This is a well-validated and vetted tool that
and the patient. allows clinicians to assess a patient’s overall mood
and (depressed) state. The 30 questions are bino-
mial (yes/no), and the number of yes/no answers is
Depression/Seclusion tallied and converted to a “level” of depression—
from normal to severe depression [27].
Depression in the older population is seen mainly If the GDS is too complicated for regular
in those patients who suffer from chronic medical use, the Patient Health Questionnaire (PHQ)-2
problems and those with cognitive impairment. tool is a significantly shorter screening tool.
Depression can lead to suffering, family prob- While this is not intended to diagnose or moni-
lems and increased levels of disability and may tor depression and its severity, it is an initial
worsen a patient’s morbidity and ultimately cause step in evaluating patients for depression.
mortality. There is documented evidence that Those patients who screen “positive” on the
medical illness is associated with depression, and PHQ-2 should then be further evaluated for
the greater the medical burden a patient suffers, major depressive disorder. The PHQ-2 asks two
the greater the risk for depression. Depression questions on a 0–3 scale. The questions are
may be associated with dementia or cognitive based off the same root but relate to 1,anhedo-
decline, as well as a risk factor for dementia later nia, and 2, mood (Table 35.3) [28]. Patients
in life [23]. with a score of 3 or greater had an 83 % sensi-
Low socioeconomic status, poor physical con- tivity and 92 % specificity for major depression
dition, disability, isolation, and seclusion are all The PHQ-2 tool has also been shown to relate
linked to depressed mood and may cause worsen- to a decline in functional status; as scores
ing depression. Of extreme concern is the risk for increase, functional status decreases [29].
suicide. Depression is present in nearly 80 % of
elderly patients who commit suicide, and depres-
sion has been identified as a major risk factor for
suicide attempts. Not just major depressive disor- Comorbid Conditions
der but also minor depression, dysthymic disor-
der, psychotic disorder, and anxiety disorders all Part of the preoperative assessment of any
raise the risk for suicide. Those patients who suf- patient is consideration of underlying comorbid
fer from seclusion and broken social bonds are at conditions as they relate to a patient’s overall
risk for suicide outside of a diagnosis of depres- outcome. This is necessary for any patient,
sion [23]. regardless of their age, but it is of particular
Social isolation is associated with the mainte- importance in older patients. Older patients may
nance of health and a deterrent to cognitive not be able to handle severe stress as well as
decline (Principles I and II). Studies have shown younger patients; therefore, optimal preopera-
that those patients who do not maintain social ties tive preparation is essential, and attention to
are at increased risk for cognitive decline over detail intra- and perioperatively is essential to
time [24]. Additionally, a robust social network reduce risk (Principles I, II, III, IV, V). There
has been shown to have protective effects against are many tools to evaluate the affect that comor-
dementia and cognitive decline [25]. Patients bid conditions have on surgical risk and out-
who are socially engaged have been shown to comes, and risk calculators are essential to take
have an improved subjective quality of life when these conditions into account.
compared to their age-adjusted counterparts [26]. One such tool is the Charlson Comorbidity
The Geriatric Depression Scale (GDS) was Index. While this scoring system was originally
developed as a screening tool for older patients or developed for women being treated for breast
Table 35.3 Patient Health Questionnaire-2: initial screening test for depression
If a patient has a positive response to either question, then further evaluation is needed. For older adults consider the
Patient Health Questionnaire-9 or the Geriatric Depression Scale. A negative response to both questions is considered
negative for depression
Modified from Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depres-
sion screener. Med Care 2003; 41:1284–92
cancer, many studies have shown validity and Table 35.4 lists the components of the Charlson
applicability to both genders and many different Comorbidity Index and the scores for each
medical and surgical conditions [30]. condition.
The Charlson Comorbidity Index takes the Ultimately, it is the sum of a patient’s comor-
following conditions into account: myocardial bid conditions that affect their overall health and
infarction, congestive heart failure, peripheral well-being. Surgeons must take all comorbidities
vascular disease, cerebrovascular accidents, into account when planning a procedure. As the
hemiplegia, pulmonary disease (asthma, COPD, Principles state, scrupulous attention to details
chronic bronchitis), diabetes, organ damage pre-, intra-, and postoperatively will help prevent
from diabetes, moderate to severe renal disease, complications.
liver disease, ulcer disease, cancer, metastatic
disease, dementia, rheumatic disease, and HIV/
AIDS. Each condition/situation is given a value
(1, 2, 3, or 6). The sum of the score is then cal- Caregiver Burden
culated. In the initial studies, patients with a
score of 0 showed a 12 % rate of mortality As patients age and they become more reliant on
within 1 year; 1–2, 26 %; 3–4, 52 %; and >5, others to help with both simple and complex
85 %. In their 10-year follow-up, the mortality tasks, there comes a second (or third) party into
had changed to 0, 8 %; 1, 25 %; 2, 48 %; and >3, the conversation regarding care and planning of
59 % [30]. More recently, studies have linked a surgical procedures. A patient’s caregiver (if
higher Charlson Comorbidity Index score with applicable and appropriate) must be taken into
hospitalization and age-related mortality [31]. consideration. The Zarit Caregiver Burden
Table 35.4 Charlson comorbidity index conditions Conclusion

Assigned score/
Condition value All are capable of providing high-quality care.
• Myocardial infarction 1 While the care of the older surgical patient does
• Congestive heart failure
not require any particularly novel or different
• Peripheral vascular disease
• Dementia skills, it does require attention to the Principles.
• Chronic pulmonary disease By taking these seemingly commonsense con-
• Connective tissue disease cepts and integrating them into daily practice,
• Ulcer disease
patients will benefit from the highest quality and
• Mild liver disease
• Diabetes safest care available.
• Hemiplegia 2
• Moderate or severe renal
disease References
• Diabetes with end-organ
damage
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• Any tumor
RA, Zenilman M, Katlic MR, editors. Principles and
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development and validation. J Chron Dis. a predictor of surgical outcomes in older patients.
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emotional and physical stress that is placed upon cog as a screen for dementia: validation in a
population- based sample. J Am Geriatr Soc.
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Originally developed for those taking care of 6. Borson S, Brush M, Gil E, et al. The clock drawing
patients suffering from dementia, it has been test: utility for dementia detection in multiethnic
applied to other medical diagnoses with consis- elders. J Gerontol A Biol Sci Med Sci.
1999;54(11):M534–40.
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come from the Zarit Caregiver Burden quality indicators for elderly surgical patients. Ann
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Patient Transitions and Handovers
Across the Continuum of Surgical 36
Care
Donna M. Woods and Lisa M. McElroy
“Life is pleasant. Death is peaceful. It’s the transition that’s troublesome.”

—Isaac Asimov
Care transitions and communication are also a

Introduction contributing factor to 91 % of medical errors
reported by residents [2]. In surgical care, events
Transitions Overall and Their Risks related to surgical care transitions represent 24 %
of malpractice claims [3], 29 % of physician
The goal of surgery is total recovery—for the sur- reported adverse events (http://www.ahrq.gov/
gical patient to come out better than before. One professionals/prevention-chronic care/improve/
key challenge to safe and effective surgery are the coordination/index.html. Accessed 26 Sept 2015),
numerous and complex transitions of care involved and 46 % of surgical care-related sentinel events
in the process of providing surgical care to a [4]. Care transitions, while not a technical aspect
patient. The effective transfer of responsibility for of surgical care, are clearly an important contribu-
the care of the patient from one healthcare pro- tor to positive and negative patient outcomes [5].
vider to another is crucial to providing safe, high- Care transitions in healthcare are defined “as the
quality patient care. Ineffective transition movement of a patient from one healthcare pro-
processes lead to fragmented communication and vider or setting to another” (http://www.jointcom-
clinical understanding and can result in delays, mission.org/assets/1/6/toc_hot_topics.pdf.
errors, and substantial patient harm. Overall, care Accessed 26 Sept 2015). These transitions can
transitions and clinical communication have occur (1) within a setting (e.g., hand-offs at shift
emerged as the root cause of 75–89 % of sentinel changes), (2) between settings (e.g., OR to ICU,
events in 2014–2015, the most serious high-harm hospital to home or skill nursing facility), and (3)
events, reported to The Joint Commission [1]. between types of providers (e.g., primary care to a
specialist or surgeon). Care transitions are a set of
actions designed to ensure coordination and conti-
D.M. Woods, EdM, MA, PhD (*) nuity of patient care. There are key identified transi-
Center for Healthcare Studies, Institute for Public
Health and Medicine, Feinberg School of Medicine,
tions in the care of the surgical patients that include
Northwestern University, 633 N. St. Clair Street, (1) preoperative transitions into the operating room
20th Floor, Chicago, IL 60611, USA (OR) (a) surgery is scheduled, (b) sign in, time-out,
e-mail: [email protected] sign out, (2) postoperative transitions (a) OR to
L.M. McElroy, MD, MS intensive care unit (ICU) or postanesthesia care unit
Department of Surgery, Medical College of (PACU), (b) ICU or PACU to the floor), and (3) (a)
Wisconsin and Affiliated Hospitals,
9200 West Wisconsin Avenue, Milwaukee,
discharge transitions and (b) outpatient follow-up
WI 53226, USA (see Fig. 36.1). Clinician shift and service changes
e-mail: [email protected] also play a role in each of these environments.

624 D.M. Woods and L.M. McElroy
Fig. 36.1 Transitions across surgical care. Figure reprinted with permission from the American Society of
Anesthesiologists (asahq.org/psh)
Each transition of care, from one phase in the planning information to the scheduling of sur-
surgical pathway to another, presents an opportunity gery. Errors in surgical case scheduling result in
for medical error. For surgical patients, the process incorrect room and equipment preparation, as
from diagnosis to surgery involves numerous transi- well as inappropriate planning on the part of the
tions in care. From the time of diagnosis, the patient surgeon and surgical team. Although some vari-
encounters a variety of clinicians, from primary care ability between scheduled and actual procedures
to diagnostic specialists. The surgical referral and due to progression of disease or unexpected
scheduling process may be arduous and can occur intraoperative findings cannot be avoided, accu-
over weeks to months. Following surgery, care may rate case scheduling is integral to OR efficiency,
be provided in many different settings, including the and errors have the potential to lead to increases
PACU, the ICU, rehabilitation, long-term care facil- in OR time, wasted supplies, and opened but
ities, and finally the patient’s home. There are often unused surgical instruments, ultimately dimin-
numerous caregivers helping with recovery, but the ishing patient and staff satisfaction and increas-
care teams are frequently not well integrated [6]. ing costs [7, 8].
This chapter will discuss recent advances and A recent study by Pariser et al. analyzed the
remaining challenges in improving the quality of delays in start time and changes in total case time
surgical care transitions to ensure patient safety associated with incorrectly scheduled surgical
during the major phases of surgical care, from sur- cases [9]. The authors analyzed 14,970 surgical
gical scheduling to discharge and in the period of cases, 3.3 % of which were found to be incor-
recuperation and recovery following discharge. rectly scheduled. Incorrectly scheduled cases
were shown to lead to OR delays, longer turnover
times, and cases going beyond scheduled length
The Transition (mean 26 min). For those surgeons who have
into the Operating Room high heterogeneity of practice, the implementa-
tion of a more robust, multilayered scheduling
The Surgery Is Scheduled process allows more detail to be conveyed in the
OR scheduling system and increases scheduling
Whether initially encountered in the hospital or reliability [9].
clinic, one of the first hurdles encountered is One of the most significant consequences of
accurate translation of surgical diagnostic and incorrectly scheduled cases is their connection to
36 Patient Transitions and Handovers Across the Continuum of Surgical Care 625
surgical errors, such as wrong-site surgery. Sign In/Time-Out/Sign Out

Several studies have linked the surgical schedul-
ing process to the downstream occurrence of The WHO Surgical Safety Checklist
wrong-site surgery [10–14]. Wu et al. looked at
over 17,000 scheduled surgeries and found that According to The Joint Commission, wrong-site
wrong-side errors were the most common surgery was the most common sentinel event
(N = 55, 36 %). In plastic surgery wrong-side reported between 2004 and 2010 [15]. The Joint
errors were most common, whereas general sur- Commission has been working for decades to
gery had mostly wrong-approach booking errors standardize and implement guidelines known as
(N = 16, 43 %). Most surgical booking errors the Universal Protocol as a verification step to
were caught in the holding area or the OR ensure the accuracy of all patient information at
(N = 122, 81 %). The remaining errors were the transition to the OR prior to the start of the
caught in the admitting or assessment areas procedure [15]. The World Health Organization
(N = 28, 18 %) [10]. Abecassis et al. [11] per- (WHO) developed and implemented a surgical
formed a systematic review of the literature safety checklist that contains three components,
reporting root causes of wrong-site surgery, and the sign in, time-out, and sign out, which apply to
surgical scheduling was found to be the most vul- three phases of surgery, respectively: before
nerable aspect of the process with reports of 39 % induction of anesthesia, before skin incision, and
of wrong-site surgeries attributable to errors in after the completion of surgery before the patient
surgical scheduling [15]. leaves the OR. Each phase involves a verification
Despite these challenges, many of the surgi- process with all members of the surgical team,
cal scheduling processes are amenable to opera- who must be in agreement with one another
tional interventions to reduce communications before the procedure can continue. Use of the
errors and improve surgical scheduling accuracy WHO surgical safety checklist has been linked to
[16]. Effective application of lean processes and improvements in patient outcomes, compliance
root cause analyses have been shown to assist with standard processes of care, and the quality
with the identification of key drivers in the proof teamwork in the OR [20, 21]. Although the
cess and in the implementation of interventions WHO provides informational materials on how
to reduce surgical listing errors and improve the to conduct the safety checklists, OR teams are
accuracy of scheduled operative times, such as frequently not provided with this information in a
centralized scheduling [5, 16–18]. Simon structured educational format. Instead, individual
describes the transition from paper to electronic centers and surgical specialties decide for them-
surgical scheduling for orthopedic procedures. selves how to use the checklists, including who
The development and implementation of the new will lead them, when they are initiated, and what
scheduling system was guided by lean problem- measures are in place to ensure compliance [22].
solving and facilitated by a multidisciplinary The result is wide variability. Observational
work group [19]. The new system saw a reduc- studies of surgical time-outs and sign outs in the
tion in lag time between surgical planning and United States, United Kingdom, and Australia
the patient notification that surgery would be have demonstrated that the sign in, time-out, and
needed from three days to less than one day. Site/ sign out are often abbreviated, with absent or
side discrepancies went from 4 % for clinic pro- non-participating team members. Time-out
cedures and 2 % for operative procedures to zero checks are often completed after commencement
for each [19]. Patient satisfaction also increased, of the procedure or are skipped entirely [23–25].
with Press Ganey scores increasing by 20 %. Additionally, current approaches to ensuring
Even with an electronic system, several checks compliance with the WHO checklists are often
need to be in place to prevent surgeons or office executed in a yes/no manner, and team members
staff from clicking or selecting the wrong sur- rarely actively participate checklists in comple-
gery [19]. tion of the process [26].
Adherence to a presurgical checklist, along transfer involves cross-disciplinary staff with

with the time-out, has been shown to reduce mor- varied experience; the delivering team members
bidity and mortality [20, 27]. Though effective with their diverse yet important perspectives of
when performed correctly, in our studies, we con- the course of surgery; and the receiving team
ducted a multi-site study of video observations of concurrently stabilizing, assessing, and making
the use of the surgical safety checklist in the OR care plans for the patient [32]. It is not surpris-
prior to donor hepatectomies [28] and found that ing, under these circumstances, that postopera-
sign-in was performed 83 % of the time and the tive transitions are plagued by technical and
complete sign-in protocol was performed for only communication errors with deleterious effects
20 % of the procedures. The elements most fre- on patient outcomes [33–38].
quently omitted were antibiotics given (75 %) fol- Transitions involving the ICU lead to more
lowed by team introduced (50 %) and procedure to errors and adverse events when compared to
be performed (50 %). The full team was focused other hospital units, and a significant percent-
on the sign-in 80 % of the time. The time-out age of these adverse events occurring in the
occurred in 100 % of the videoed procedures; ICU are potentially life threatening to the
however adherence to the institutional protocol patient [39].
occurred 38 % of the time. The most frequently Our group investigated risks of patient harm
omitted were procedural equipment (62 %) and during OR-to-ICU handoffs, using liver trans-
patient positioning 50 % followed by site marked plant recipients as a model for a failure modes,
(32 %). The full team was focused on the time-out effects, and criticality analysis (FMECA). We
for 75 % of the procedures [28]. Other studies identified 37 individual steps in the OR-to-ICU
have demonstrated use in only 70 % of procedures handoff process. In total, 81 process failures
and large variation in their use [29]. The result is were identified, 22 of which were determined to
the surgical team having incomplete patient infor- be critical and 36 of which relied on weak safe-
mation and surgical errors leading to harm in sur- guards, such as informal human verification.
gical patients. Dixon Woods et al. have shown that Process failures with the greatest risk of harm
unless surgical team members are engaged in the were lack of preliminary OR-to-ICU communi-
surgical checklist process, little to no gain may be cation, team member absence during handoff
achieved with surgical checklists [30]. communication, and transport equipment mal-
function [40]. Post hoc analysis revealed the
need for early OR-to-ICU communication, the
Postoperative Transitions challenge of the competing demands and relative
prioritization of clinical care versus participation
The transfer of care after surgery to the PACU or in handoff communication, and the role of inter-
ICU presents special challenges to providers on personal relationships within and between OR
both the delivering and receiving teams. The OR and ICU teams. The limited common ground
anesthesia and surgical team must physically reduced the likelihood of correct interpretation
transport the patient, along with any monitoring of important handover information, which may
equipment from the surgical procedure. The contribute to adverse events [6]. Institutional
physical transition occurs, while team members culture and interdepartmental relationships were
also simultaneously provide continuous moni- also reported to greatly influence behavior dur-
toring, perform additional therapeutic tasks, and ing this transition [41]. Members of the OR and
avoid potential pitfalls such as physical hallway ICU teams described different priorities for a
obstructions [31]. Upon arrival at the receiving high-quality handoff process, including the opti-
unit, the technology and support are transferred mal timing and content of handoff communica-
to stationary equipment, while knowledge of the tion, as well as whether handoff communication
patient is transmitted, in an environment that is should take priority over initiation of clinical
often chaotic and busy, and to a team largely care in the ICU. The varied opinions among par-
unfamiliar with the patient. This knowledge ticipants demonstrate the potential success of
interventions that clarify roles, responsibilities, information and may result in increased rates of
and expectations [42]. This study also deter- complications.  A recent prospective analysis of
mined attributes of high-quality OR-to-ICU PACU transfers found that critical aspects of
transitions to include the following: care such as fluid and pain management were
transferred in less than 20 % of the transitions
– Communication from the OR to the ICU of [44, 45]. The shortest handover lasted only 1 s.
the start time of the surgery. Although it is difficult to define exactly what
– Communication of the start time of closing by constitutes adequate length of time for a hando-
the anesthesia resident following first instance ver, the longest was only 300 s.
of counts.
– The ICU charge nurse calls the ICU resident
and charge respiratory therapist. he Transition of the Postoperative
T
– The charge respiratory therapist assigns the Patient from the ICU or PACU
respiratory therapist to bring the vent to the ICU. to the General Floor
– The primary surgeon, fellow, anesthesiologist,
and resident conduct a huddle. An ICU-to-ward patient transfer consists of
– The OR nurse communicates to the ICU that several steps, beginning with a consult request
the procedure has ended and that they are pre- for patient transfer from the ICU service and
paring to transfer to the ICU. with the initial patient assessment by the
– The surgical and ICU teams perform the ver- receiving physician(s) following the patient’s
bal transfer. arrival on the ward. During the transfer pro-
– The surgical fellow completes the surgical/ cess, there is often conflict between the need to
ICU transition note [43]. physically settle the patient and the need to
receive information, and the perceived needs of
Finally, interpersonal dynamics between team the postoperative patient may supersede the
members were reported to affect care transition need for information exchange [46, 47]. There
quality, and there was a general recognition that is also frequently confusion as to who is
even a single “difficult” team member could responsible for receiving which specific infor-
compromise patient safety by discouraging open mation. Physician-to-physician and nurse-to-
communication [43]. nurse communications occur at different
phases of the transition, with respective groups
communicating different aspects of the care
Postanesthesia Care Unit (PACU) plan, and the overall transition process,
whether from the ICU or PACU to the general
ICU and PACU have different challenges in floor or from the hospital to home, may take
safely transitioning care of a surgical patient. several hours, further contributing to frag-
The PACU is the standard location for the initial mented care [48].
recovery of the postoperative patient. The con- Li et al. conducted a prospective observational
cept of the PACU was first introduced in 1923, study of physician handoff for 112 ICU-to-ward
yet far less research has been done examining patient transfers and showed a significant defi-
transfers to the PACU than transfers to the ciency in physician-to-physician communication
ICU. Postoperative patients are at higher risk for despite overall satisfaction with the handoff pro-
complications or death when their surgical cess by involved providers and patient families
teams exhibited less briefing and information [49]. Helling et al. recently examined incidents of
sharing during the transition [44]. Studies of unexpected clinical deterioration in surgical
postoperative transitions to the PACU have patients on standard nursing units. Of 111 of these,
repeatedly demonstrated that the process is 90 % had been recently discharged from an ICU or
largely informal, unstructured, and incom- PACU, overall mortality was 27 %, demonstrating
plete. This involves the risk of losing relevant the potential severity of these issues [50].
While ICU staff typically notified and teams, medical emergency teams, critical care
explained to patients and families that a trans- outreach teams, or ICU nurse liaison programs
fer to the general ward was pending, there was that provide follow-up for patients discharged
a general lack of interactive physician commu- from the ICU. CCTPs appear to reduce the risk of
nication during the patient transfers, and ICU readmission in patients discharged from
physician-to- physician communication was ICU to a general hospital ward. A meta-analysis
largely unstandardized. In addition, during of studies on CCTP demonstrated a reduced risk
transfers there was ambiguity with regards to of ICU readmission (risk ratio, 0.87 [95 % CI,
physician responsibility for patient care. 0.76–0.99]; p = 0.03; I2 = 0 %); however, no sig-
Finally, 35.7 % of these transfers took place nificant reduction in hospital mortality (risk ratio,
during night and weekend shifts, despite an 0.84 [95 % CI, 0.66–1.05]; p = 0.1; I2 = 16 %) is
increased incidence of physician cross cover- associated with a CCTP. The rarity of the out-
age duties and reduced numbers of residents come (unexpected mortality) may have resulted
and ancillary staff. Important information that in insufficient power to detect a significant differ-
was often missing in handoff documents ence. The risk of ICU readmission was similar
included pending investigations, recommenda- whether the transition program was included
tions arising from specialist consultations, and within an outreach team or a nurse liaison pro-
changes of important medications [49]. gram and did not depend on the presence of an
The length of time that a patient stays in the intensivist [52].
PACU is variable. While it is common practice
for PACU discharge policies to stipulate a mini-
mum length of stay, beyond that, a surgical Shift and Service Handoff Transitions
patient’s readiness for discharge traditionally
relies upon a nursing assessment of the appropri- Communication, teamwork, and shift and ser-
ateness of physiological parameters. Recently, vice change transitions are a major challenge in
guidelines for the management of patients in the healthcare and require a mention in the context
PACU and assessing their readiness for transfer of care transitions [53]. Transitions in patient
have been proposed. Twenty-four essential crite- care also involve the transfer of responsibility
ria were identified through expert consensus [51]. between work shifts in the contexts of the ICU,
In Canada, criteria considered essential for PACU, and the general floor. These interactions
assessing when a patient is clinically stable and are particularly error prone due to a multitude
ready for transition from PACU included those of factors [54, 55]. Incomplete information
related to (1) cardiac and respiratory function, exchange, nonstandardized formats, time pres-
such as blood pressure, pulse, respiratory rate, sures and other human factors, fragmented
oxygen saturation, end-tidal CO2, arrhythmia, teams, and environmental distractions and con-
shortness of breath, respiratory stability, and ditions contribute to the overall failures of com-
tachycardia; (2) mental status, such as alertness, munication at the root of the problem. Missing,
level of consciousness, sedation level, and coor- incorrect, or incomplete patient care infor-
dination; and (3) postsurgical factors, such as mation exchange is common in handoffs and
pain, surgical bleeding, temperature, postopera- includes medications, labs and tests to be per-
tive urinary retention, urine output, nausea and formed and results, information regarding diag-
vomiting, and functional status. No corollary has noses, and the patient’s plan of care. Physicians,
been proposed in the United States, and there are nurses, and other care providers report direct
currently no widely accepted professional guide- patient harm due to handoffs and cite competing
lines for PACU transition [51]. demands, frequent interruptions, and the lack of
Critical care transition program (CCTP) is an transfer of critical information as contributing
overarching term which includes rapid response factors [54–56].
The Discharge Transition operative care quality. The surgical discharge is a

critical transition of care, as effective discharge
he Discharge Transition Process:
T failure often results in an emergency room visit
What Is Involved? or readmission, both of which are care quality
concerns.
Patients who have undergone surgical procedures A recent Cochrane review investigated the
often have self-care concerns and information effectiveness of planning the discharge of indi-
needs in the preparation for the discharge transi- vidual patients from the hospital [60]. They found
tion from the hospital. The most common con- that although discharge planning may lead to
cerns are related to the incision/wound care, pain increased satisfaction with healthcare for patients
management, activity level, monitoring for com- and professionals, a discharge plan brings only a
plications, symptom management, elimination, small reduction in hospital length of stay or risk
medications, and quality of life. Because of their of readmission at 3 months follow-up, for older
clinical knowledge of the perioperative experi- people with a medical condition. This difference
ence, advanced practice nurses have a critical in risk has not been shown in surgical patients,
role in the development of discharge-educational and there is little evidence that discharge plan-
programs for postoperative patients and caregiv- ning reduces costs to the health service. Care
ers. Because unmet discharge needs can contrib- coordination that provides more than just dis-
ute to poor patient outcomes and readmission, it charge planning appears to be needed.
is critical that clinical staff nurses and social Care coordination as defined on the AHRQ
workers accurately identify patients’ informa- website “involves deliberately organizing patient
tional needs and find ways to meet these needs, care activities and sharing information among all
especially with aging populations, new/advanced of the participants concerned with a patient’s care
surgical procedures, vulnerability/poverty, and to achieve safer and more effective care. This
literacy and health literacy levels of patients [57, means that the patient’s needs and preferences
58]. Patient understanding of and adherence to are known ahead of time and communicated at
discharge instructions and appropriate follow-up the right time to the right people, and that this
care are critical to successful discharge transition information is used to provide safe, appropriate,
and recovery [59]. However, there are key chal- and effective care to the patient” [61].
lenges in the postoperative discharge transition In a survey study of the impact of patient and
including, coordination with others of the provider coordination across the continuum of
patient’s care providers and ensuring the restora- care on outcomes for surgical patients, knee-
tion of any home medications that may have been replacement surgery patients were asked about
discontinued during the surgical admission. the coordination of their discharge care. Patients
identified serious communication breakdowns
between providers, as well as between providers
Risks Associated and patients. Measured 6 weeks postsurgery,
with the Postoperative Discharge coordination of care problems were associated
Transition with adverse health outcomes—greater joint
pain, lower functioning, and reduced satisfaction.
There is no universally accepted definition of The average patient reported problems on 42 %
recovery after surgery, and it is well accepted of the indicators related to coordination of dis-
that the recovery process is variable and depen- charge. Widespread problems included not being
dent on many patient and operative procedural told what problems related to surgery to watch
factors. While this variation is acceptable for for (46 %) and not being informed about medica-
long-term recovery after surgery, short-term tion side effects. More than a third (39 %) said it
recovery is often marked by discharge from the was not easy to find someone to talk to about
hospital and is an important benchmark of post- their concerns [62].
trategies to Improve
S have already been tested in multiple large-scale
the Postoperative Discharge healthcare systems such as the National Health
Transition Services in the United Kingdom for colorectal
surgery [69]. ERAS has been shown to decrease
Care coordination is a key component of a safe the incidence of postoperative complications and
and effective postoperative discharge transition. decrease the LOS in the hospital, without the use
As readmission rates after surgery become a of new equipment [70].
more prominent metric of quality, increased
attention has been paid to the quality of the dis-
charge transition and coordination of care after Perioperative Surgical Medical Home
surgery [63]. A few care models have been
advanced: the Transitional Care Model, the Similar but distinct from ERAS protocols is the
RE-Engineered Discharge Model, and specifi- perioperative surgical home (PSH) [71]. The PSH
cally for surgery the Care Coordination for Care is a much larger conceptual framework that
Improvement Initiative [41]. includes coordination of care from the minute the
The Care Coordination for Care Improvement decision to operate was made until 30 days after
Initiative was developed to improve the quality discharge. PSH assures continuity of care and
of patient care while easing the transitions that treats the entire perioperative episode of care as
happen before, during, and after surgery. The one continuum rather than discrete preoperative,
initiative is designed to follow patients through intraoperative, postoperative, and post-discharge
their continuum of care, from surgical decision episodes (see Fig. 36.2).
through 90 days after discharge. This initiative In this model the interdisciplinary team is
involves the use of a nurse navigator, that is headed by anesthesiologists, who manage all
assigned at the time of the decision that surgery isaspects of care across this continuum. The PSH
necessary who will provide ongoing care coordi- involves the following components of care: the
nation through the entire surgical episode (https://importance of preoperative nutrition and hydration,
www.sosbones.com/services/care-coordination- focus on pain control with minimal opioid use,
for-care-improvement-initiative/). aggressive postoperative ambulation, as well as the
prominent role the patient plays in their recovery. A
nurse coordinator can be added to the team as well.
Enhanced Recovery After Surgery In one study, this model resulted in reduction of 30
(ERAS) readmission from 17.3 % to 9.2 %, surgical site
infections from 21 % to 7 %, and UTIs from 3 % to
Kehlet, a renowned colorectal surgeon from 0, satisfaction with pain control was increased from
Copenhagen University Hospital in Denmark, 43rd to 98th percentile on the Press Ganey survey,
was the first to describe the concept of ERAS in and “the extent that the patient felt ready for dis-
the 1990s [64, 65]. The ERAS protocol is a wide- charge” increased from 41st to 99th percentile
reaching collection of about 20 specific clinical (https://www.google.com/?gws_rd=ssl#q=Periope
practices aimed at reducing length of stay after rative+Surgical+home+University+of+Virginia.
surgery. These include reduced preoperative fast- Accessed 16 Jan 2016). PSH protocols will vary
ing, preoperative carbohydrate loading, avoidance significantly across institutions, as they will depend
of premedication, and others. When originally on the surgical services, the local perioperative
introduced, the ERAS protocol was used environment, and active participation of all stake-
specifically for patients undergoing colorectal holders. Although both ERAS and PSH have the
surgery, but subsequently the use of this protocol same goals of better outcomes, better service, and
has expanded to other surgical subspecialties [66– lower cost, the route that these two methodologies
68]. To date, ERAS protocols have been embraced are taking to achieve these goals may be different
in several European and Canadian institutions and but complementary [72]. Widespread use of the
Fig. 36.2 Perioperative surgical home. Figure reprinted with permission from the American Society of Anesthesiologists
(asahq.org/psh)
ERAS protocols and PSH will depend on further istics of a transition of care and outcomes [74].
demonstration of their effectiveness, both in The authors found that care transition research is
improving patient outcomes and containing costs. highly diverse and as such presents a serious chal-
Future studies investigating the effectiveness of lenge to researchers and practitioners. Because it
these interventions should focus on higher-level is unclear what they can gain with certainty from
outcomes, such as functional status, which encom- previous studies to use when designing future
pass the multidimensional nature of recovery, as research and improvement initiatives. Even inter-
well as on the validation of instruments and mea- ventions that have been shown to improve surgi-
sures for these outcomes [73]. cal care and outcomes and reduce adverse events
(e.g., surgical safety checklist) are inconsistently
performed. Even when interventions are well
Conclusions and Implications defined, they are idiosyncratically and unreliably
implemented. It can be hard to copmpare results
Prior research has identified specific causes of and detrmine the generalizable impact of the
medical error and harm in the context of transi- results. Additionally, given variability of proto-
tions of care. Literature review and consensus cols and inconsistent implementation for many of
panels have been used to elucidate essential ele- the interventions that are recommended in the lit-
ments of the challenges and methods for reliable, erature to improve outcomes, makes the effect of
improved patient transitions across the surgical any one or a combination of best practices on out-
care continuum. A recent systematic review has comes, their replicability, and broad implementa-
taken the implications of transition of care quality tion a challenge [75].
one step further, by assessing the empirical evi- New more comprehensive models involving
dence for the relationships between the character- multimodal interventions (e.g., ERAS, PSH, CCTP)
are emerging that will redefine the way surgical care 13. Blanco M, Clarke JR, Martindell D. Wrong site sur-
gery near misses and actual occurrences. AORN
is delivered. These are largely focused on improv-
J. 2009;90(2):215–8, 221–2.
ing the many patient care transitions across the con- 14. Seiden S, Barach P. Wrong-side, wrong procedure,
tinuum of surgical care and will require a more and wrong patient adverse events: are they prevent-
comprehensive approach to the improvement of able? Arch Surg. 2006;141:1–9.
15. Clark C. Joint commission unveils wrong site surgery
surgical services [76]. Therefore, to be successful in
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patient safety and outcomes must be cultivated.
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Failure to Rescue and Failure
to Perceive Patients in Crisis 37
Christian Peter Subbe and Paul Barach
“Failure isn’t fatal, but failure to change might be.”

—John Wooden
coded complications following surgical complica-

ailure to Rescue and the Context
F tions and subsequent mortality and morbidity [2].
of Surgical Patient Management Failure to rescue is an important metric from the
point of view of patients, health care professionals,
Definition and health care organizations. Efforts have been
focused on reducing complications of surgical pro-
The hallmark of a safe and reliable hospital is the cedures by improving the awareness and perfor-
ability to identify, address, and prevent a compli- mance of the surgical microsystem while optimizing
cation from leading to lasting patient harm and infection risk through better hygiene and preventa-
suffering with safety defined as “freedom from tive measures and optimizing team related pro-
accidental injury” [1]. Failure to rescue surgical cesses through usage of checklists [3] and changes
patients is defined as mortality after a complica- in the team culture [4]. At the same time variability
tion occurring in patients who are hospitalized in patients, surgical performance, human errors,
after a surgical procedure or with surgical disease. unpredictable and preventable technical faults, and
Initially limited to surgical patients the term has simple bad luck may mean that a percentage of
subsequently been used more broadly in the con- patients will suffer complications even in a vastly
text of patients who suffer avoidable complica- improved system [5]. In these circumstances
tions despite visible and early warning signs. The patients need to be reassured that every effort is
original work on failure to rescue focused on being made to detect the complication, treat it and
restore them to their full health [6]. Health care pro-
fessionals would like to be reassured that their
C.P. Subbe, DM, MRCP (*) errors do not result in fatal outcomes or impact on
Department of Internal Medicine, Ysbyty Gwynedd,
the chronic health of their patients, both for their
Penrhosgarnedd, Bangor, Gwynedd LL57 2PW, UK
own peace of mind and their standing amongst their
School of Medical Sciences, Bangor University,
peers [7]. Healthcare organizations need to reassure
Bangor LL57 2AS, UK
e-mail: [email protected] themselves that a single error or mishap does not
lead to long-term cost implications and legal and
Clinical Professor, Children’s Cardiomyopathy professional consequences.
Foundation and Kyle John Rymiszewski Research The management of failure to rescue has been
Scholar, Children’s Hospital of Michigan, seen as the hallmark of the best performing health
systems. A 2009 analysis of US Medicare data from
Woodward Avenue, Suite 13001, Detroit,
MI 48202, USA the 20 % hospitals with the best adjusted mortality
e-mail: [email protected] rates and the 20 % hospitals with the worst mortality

636 C.P. Subbe and P. Barach
rates demonstrates that the corresponding complica- hierarchical gradients perhaps due to the lack of psy-
tion rates in major surgical cases between these two chological safety and the inability to assuredly speak
hospital groups seems to be much less different than up about concerns [15]. Even within healthcare sys-
one would expect [8]. While the difference in mor- tems and between different procedures significant
tality was 3 % vs. 8 % (i.e., a factor of nearly 3) the differences in the rate of failures exist [8, 16].
small differences in coded complications was only Variation in failure to rescue in a detailed study from
3.7 % (32.7 % vs. 36.4 %). While the quality assur- New South Wales, Australia, was largest in hip
ance of the coding was not part of the study’s objec- replacement, knee replacement, and cholecystec-
tives it is reasonable to assume that the best hospitals tomy patients [17]. Larger organizations fared worse
also code better and therefore capture more of their in this study in contrast to other previously published
complications, and that the real difference might be work on single disease groups [18–20]. How might
even smaller. The difference in failure to rescue rates the hospital or unit size affect the ability to identify,
was, however, 6.8 % vs. 16.7 %, with an odds ratio of address, and recover from system failures?
2.43 (O.R. = 2.30–2.58). This difference persisted
for different types of patients and complications
such as pneumonia, post-operative myocardial urgical Clinical Microsystem
S
infarction, and surgical site infections. and Implications for Rapid Response
Success and Impact
Epidemiology
The seminal report “To Err is Human” is seen as Several models of care delivery have emerged as
the document that empowered healthcare profes- health care institutions face challenges in provid-
sionals to open up about the preventable flaws of ing safe, reliable, and effective health care in a
their work and was key in addressing the impor- complex regulatory and financially burdened
tance of creating a culture of safety [1]. The environment [21]. Microsystems, small team of
acknowledgement that in hospital patients come providers, based on work of intelligent enter-
to harm as often as 10 % of all admissions is evi- prises by Quinn applies systems thinking to orga-
dent from studies in many developed health care nizational design and represent the smallest
systems. The Health Foundation’s literature replicable organizational unit of change and can
review on “Levels of harm” demonstrated this be applied to assessing Rapid Response Team
prevalence [9]. The authors concluded that “peo- (RRT) impact and uptake [22].
ple receive only half of the appropriate care for The goals of the microsystem are as follows:
their condition.” Unsurprisingly, the highest rates
of adverse events are being experienced by older The five essential goals (5 Ps) of the microsystema
patients, patient with mental health issues, and in 1. Purpose. What is the purpose of the clinical
microsystem and how does that purpose fit within
those requiring a longer hospital stay. The latter the overall vision?
might be simply due to the fact that their exposure 2. Patients. Who are the people served by the
time to risk is longer and that there are therefore microsystem?
more opportunities to “get things wrong.” 3. Professionals. Who are the staff who work together
in the microsystem?
4. Processes. What are the care-giving and support
processes the microsystem uses to provide care and
Impact of Culture and Climate of Care services?
5. Patterns. What are the patterns that characterize
Failure to rescue has been measured in a number of microsystem functioning?
studies from the USA [1], Canada [10], New Zealand
[11, 12], Netherlands [13], and the UK [14]. a
From Barach P, Johnson JK. Understanding the complex-
Organizational culture and the working relation- ity of redesigning care around clinical microsystem. Qual
ships of those caring together might be a key ingredi- Saf Health Care 2006;15(Suppl 1);10–6; with permission
ent for improved rate of failure to rescue. Failure to Quinn studied companies that achieved con-
rescue is more common in organizations with steep sistent growth, high quality, and high margins
37 Failure to Rescue and Failure to Perceive Patients in Crisis 637
as well as exceptional reputations with their impact, to enhance patient safety in microsystems
customers. He found that these smallest repli- (Box 37.2).
cable units were the key to implementing effec-
tive strategy, engendering loyalty, leveraging
information technology, and embedding other Rapid Response Systems
performance-enhancing practices into the ser-
vice delivery process. Health care microsys- Rapid Response Systems (RRS) were introduced
tems consist of a small group of people who in order to reduce the failure to rescue when
provide care to a defined set of patients and for patients had a cardio-pulmonary arrests and pre-
a particular purpose, such as the peri-operative ventable admissions to critical care units [29].
care continuum. Microsystems have both clini- Much of the literature on failure to rescue has
cal and business aims, tightly coupled pro- been published in the context of these clinical
cesses, and a shared information platform. conditions. A short introduction is therefore
Clinical, service, and financial outcomes are necessary.
measured systematically and with a view RRS consist of several parts [30]: The affer-
toward continuous improvement [23]. ent limb of the system records physiological
A microsystem’s developmental journey abnormalities and escalates care when signifi-
toward maturation and improved performance cant pre-defined abnormalities in a patient’s vital
entails five stages of growth [24] (Box 37.1). signs are evident. The efferent limb responds to
The clinical microsystem approach empha- calls from the afferent part. The third part, the
sizes identifying and promoting the strengths of system is usually supplemented by an adminis-
both the team and individuals. It maintains a trative limb and structures supporting education
focus on continuous improvement rather than (Fig. 37.1).
externally imposed targets and initiatives that The afferent limb relies on assessments of
members think do not directly have an impact vital signs such as blood pressure, heart rate,
on their work. In addition, the microsystem respiratory rate, oxygen saturations, temperature,
incorporates the experience and perceptions of and level of consciousness. Alerts triggered by
patients and their families in the strategic devel- abnormalities in some of all of these parameters
opment to deliver the most desirable service are complemented by alerts related to “nurse
from the end user’s point of views. A surgical concerns” acknowledging the fact that not all
microsystem can involve, for example, a pediat- deterioration is proceeded by measurable abnor-
ric cardiac surgical team that includes the cor- malities and the intuition, experience, and “gut
responding critical care team, wards, or perhaps feeling” is hugely important, and can supplement
a large surgical critical care unit providing ser- the quantifiable abnormalities.
vices in a defined geographic space [25]. The The efferent limb responds to calls for help
microsystem includes patients and their family from the afferent part. The efferent limb can take
members given the need for real co-production different forms in different health systems. In
convergence between patients and providers to Australia, this consisted mainly of a team of doc-
achieve a patient’s full recovery [26–28]. tors from intensive care and general wards sup-
Characteristics of high-performing microsys- ported by nurses with critical care skills (Medical
tems applied to assessing RRT teams include— Emergency Team (MET) [29]). In the UK,
leadership, organizational support, staff focus, however, critical care trained nurses would

education and training, interdependence, patient respond (Critical Care Outreach [31]), and while
focus, community and market focus, perfor- in the USA, a teams of doctors, nurses, and respi-
mance results, process improvement, and infor- ratory therapists might respond (RRT [30]). This
mation and information technology—and can be diversity and heterogeneity creates immense
linked to specific design concepts, actions and challenges in making meaningful comparisons
Fig. 37.1 Structure for a Rapid Response System
about the relative effectiveness of each of these Modernisation Agency published recommenda-
staffing models. tions on the make up of services and funding
Hospitals analyze complications as a means to from the Department of Health following the
reduce failure to rescue and improve their patient report “Comprehensive Critical Care” that lead to
outcomes [32]. The resulting discussions led rapid spread prior to detailed evaluation [37].
quickly to changes in health policy in several The largest interventional trial, a cluster ran-
countries with RRS becoming a new standard of domized study of 23 hospitals created massive
care, despite many remaining questions about interest and the majority of Australian hospitals
how best to deploy RRS and their effectiveness. adopted METs with limited follow-up. This fur-
In the USA, the 100,000 Lives Campaign chose ther impacted objective assessment [38]. The
RRTs in 2005 as one of five interventions to patient safety movements inspired by the IHI
reduce preventable mortality in hospitals. The have led to spread of national programs through
campaign run by the Institute for Healthcare Denmark and the Netherlands. Interestingly these
Improvement (IHI) resulted in some measurable have been often without attempted standardiza-
changes in hospital mortality; however, some tion of the tools used to assess patients at risk or
controversy remains regarding its generalizabil- the format of the responding team structure, lead-
ity and lasting impact [33, 34]. Subsequent spread ing to further confusion as to the effectiveness of
to the UK (supported by the IHI) resulted in ini- these interventions.
tial pilot projects in small groups of hospitals
(Safer Patients Initiative I and II) that followed
the pattern of the US campaign. Published results Chain of Survival
came to mixed conclusions [35, 36]. While there
was clear evidence of improvement in processes Principles of Reliable and Safe Care
of care and clinical outcomes in the participating
units, these improvements were in line with other Failure to rescue patients in hospital is often due
organizations that did not take part in the initia- to a systems failure and breakdown in care at a
tive. The UK’s Intensive Care Society and the number of levels which we have described as a
appropriate and timely response, and more often

Box 37.1: Clinical Microsystems: Five than not a repeat cycle to check whether interven-
Stages of Growth tions have had the desired effects (Fig. 37.2). All
elements of the chain need to function seamlessly
1. Awareness as an interdependent group in order to provide reliable and safe care [41]. The
with the capacity to make changes following sections will describe the elements of
2. Connecting routine daily work to the the chain of survival, the reasons for failure and
high purpose of benefiting patients possible mediating mechanisms.
3. Responding successfully to strategic

challenges
4. Measuring performance as a system Failure to Record
5. Juggling improvements while taking

care of patients Deterioration of patients is often clear in hind-
sight from the characteristic changes in vital
signs [42, 43] or pathology results [44]. The
majority of patients admitted to Intensive Care
Box 37.2: Questions to Ask When Units or suffering cardio-pulmonary arrests
Assessing an RRT Team’s Performance demonstrate signs of deterioration for a mini-
[39] mum of 6 h prior to the “event” [45]. In the
majority of patients failure to rescue is therefore
• Is the team the right size and not due to a failure to record vital signs but fail-
composition? ure to recognize the trend in the patient status. It
• Are there adequate levels of comple- is unclear how many patients have cardiac arrests
mentary skills? without physiological abnormalities purely due
• Is there a shared goal for the team? to the fact that no observations or no complete
• Does everyone understand the team set of observations were recorded in the hours
goals? prior to the event. In general terms, a full set of
• Has a set of performance goals been vital signs could comprise respiratory rate, oxy-
agreed on? gen saturations, blood pressure, heart rate, tem-
• Do the team members hold one another perature, level of consciousness, and possibly
accountable for the group’s results? urine output. The most powerful parameter pre-
• Are there shared protocols and perfor- dicting patient deterioration, and at the same
mance ground rules? time the most often missed vital sign, is the
• Is there mutual respect and trust between respiratory rate [46]. Respiratory rate (RR)
team members? changes with thoracic cage and lung conditions,
• Do team members communicate metabolic acidosis, infection, fever, etc. RR is
effectively? measured manually and not electronically like
• Do team members know and appreciate other key measured parameters and is more time
each other’s roles and responsibilities? consuming. The optimal frequency of observa-
• When one team member is absent or not tions for acutely unwell patients is not clear from
able to perform the assigned tasks, are the literature. A report about “Standardising the
other team members able to pitch in or assessment of acute-illness severity in the NHS”
help appropriately? by the Royal College of Physicians [47] recom-
mended at least 4 h vital signs on general wards.
In Dutch hospitals the frequency is often less
“chain of survival” [40]. Safe care of deteriorating [48]. In many other systems vital signs might
patients depends on robust and reliable recording only be assessed by healthcare providers once or
of vital signs, recognition of abnormalities, report- twice per day and consist of blood pressure,
ing of patient deterioration as soon as detected, an heart rate, and temperature only, thus potentially
Fig. 37.2 The chain of survival for the deteriorating patient on a general ward
missing opportunities to capture deterioration we usually are unaware of their effect.

through a full set of vital signs. Powerful, because they determine what we pay
Standardization of vital sign recordings might attention to, and therefore what we do. For
improve the number of opportunities for inter- example, if a young patient “looks well” with
vention. Standardization of vital sign recordings red cheeks and a smile despite a systolic blood
and analysis of abnormality is described in the pressure of 70 mg than the nursing staff is
literature as Medical Emergency Criteria [49] much less likely to trip the alarm than in an
(Table 37.1. Medical Emergency Team criteria) elderly patient who has been unwell for several
and as Early Warning Scores [50] (Table 37.2. days with the same vital signs. The perception
Modified Early Warning Score). Triggers of that young patients are usually well and can’t
abnormal physiological signs are complemented really be that ill remains an ongoing recog-
by nurse concerns as an important safety net for nized risk and a form of normalized deviance
those patients who do not or not yet exhibit gross [57]. Recognition of physiological abnormali-
abnormalities [51]. ties is often in the context of what is expected:
Validation of Early Warning Scores has been it is easier to spot “abnormal” in a patient in
undertaken predominantly in acutely unwell whom staff expect this abnormality. For exam-
medical patients [47] and to a lesser extent in sur- ple, in a post-operative patient hypotension
gical patients [52]. Standardization can be might be expected; a patient with chronic
anchored in clinical teams through training using obstructive pulmonary disease might post-
a common model to describe severity of illness operatively be more short of breath because of
[48]. Automated monitoring can also improve metabolic acidosis or volume overload but his
monitoring of post-surgical patients [53–55]. or her respiratory rate will be interpreted in the
context of their previous condition.
Furthermore, we know that elderly patients’
ailure to Recognize
F physiological response to acute illness is atten-
Pathophysiological Changes uated [58]. This might make it more difficult
for staff to classify changes in vital signs as
Perception of “illness” and mental models of “critical” and requiring further action. Age
providers about the disease severity can have a might, however, not be the defining factor for
major influence on behavior and decisions of prognosis. Crucial to the understanding of
healthcare professionals. In the words of Peter acute physiology is the underlying degree of
Senge [56]: “Mental models are deeply held frailty. Frailty is a syndrome with measurable
internal images of how the world works, metrics [59] based on pathophysiological mod-
images that limit us to familiar ways of think- eling and epidemiological data from large
ing and acting. Very often, we are not con- cohorts of aging patients (Fig. 37.3).
sciously aware of our mental models or the Increased levels of frailty are associated with
effects they have on our behavior.” Mental higher mortality, higher levels of complications
models are subtle but powerful. Subtle, because after surgery, and higher mortality after admission
Table 37.1 Modified Early Warning Score

3 2 1 0 1 2 3
Systolic blood <70 71–80 81– 101–199 ≥200
pressure (mmHg) 100
Heart rate (bpm) <40 41–50 51–100 101–110 111–129 ≥130
Respiratory rate <9 9–14 15–20 21–29 ≥30
(bpm)
Temperature (°C) <35 35–38.4 ≥38.5
AVPU score Alert Reacting to Reacting to Unresponsive
Voice Pain
Table 37.2 The Medical Emergency Team is activated phone because of real or perceived pressures of
according to the following criteria work. The failure to report can be “simple forget-
Acute physiology change in fulness” when workflow pressures and conflicting
• Airway Threatened priorities over-ride the need to escalate care. It can
• Breathing All respiratory arrests be a conscientious decision that the reporting of
• Respiratory rate ≤5 abnormalities is not a priority for the patient or
• Respiratory rate ≥36 workflow. Nursing staff might judge abnormali-
• Circulation All cardiac arrests ties to be within the expected range for a given
• Pulse rate ≤40 patient or hope that they are transient and resolve
• Pulse rate ≥140 without further intervention.
• Systolic blood pressure ≤90 mmHg
• Neurology Sudden fall in level of consciousness
• Fall in GCS Failure to Treat
• ≥2 points
• Repeated or prolonged seizures Failure to treat can be the consequence of a fail-
• Other Any patient who you are seriously worried ure to record or recognize or equally a failure
about that does not fit into the above criteria
despite recording and recognizing. Correct treat-
ment will depend on the clinical competencies
(i.e., knowledge, skills, and attitudes) of the treat-
to ICU. The majority of patients with physiologi- ing clinician and their mental model of the
cal deterioration and those experiencing failure to patient’s disease and situation [62]. Reliability of
rescue are frail [60] (Fig. 37.4). treatment can be enhanced by using “care
bundles” [63] and by making available a RRT
with critical care skills [64].
Failure to Report Complications from surgery fall into a small
number of distinct groups which have been
Reporting on patient abnormalities or staff con- labeled MET syndromes [65]. Common compli-
cerns are an important function of communication cations of surgical care are sepsis, acute kidney
between professional groups. Real or perceived injury, and hypovolemic shock. Sepsis is the
hierarchy plays a major role in acting on available combination of suspected or confirmed infection
warning signs [61]. Professionals might hesitate and Systemic Inflammatory Response Syndrome
to discuss abnormalities if they fear and lack psy- [66]. Reliability of sepsis treatment can be
chological safety or have a non-supportive recipi- enhanced using a “sepsis-bundle” that combines
ent of the information. In the context of activation key elements of diagnostics (cultures and serum
of RRS nurses might be hesitant to call a physi- lactate level) with key treatments (fluids, antibi-
cian if they fear that the physician will not take otics) and monitoring (urine output) [67]
their concerns seriously or will be short on the (Table 37.3. “Sepsis six” response bundle).
Fig. 37.3 Clinical frailty scale (reprinted with permission from CFS©)
Fig. 37.4 Breakdown of

patients who trigger a National
Early Warning Score by
degree of frailty
Table 37.3 “Sepsis six” response bundle according to units utilizing RRS [64]. However, it is not clear
[68]
whether certain sub-groups of patients or certain
The sepsis six to be delivered within 1 h hospital specialties benefitted more or less from
1. Deliver high-flow oxygen the RRS interventions.
2. Take blood cultures Properties of track-and-trigger systems in sur-
3. Administer empiric intravenous antibiotics gical patients have been described: The Modified
4. Measure serum lactate and send full blood count Early Warning Score (MEWS) was originally
5. Start intravenous fluid resuscitation created for deteriorating surgical patients [76]. In
6. Commence accurate urine output measurement a cohort of patients from a UK university hospital
the reliability of an Early Warning Score for iden-
tifying patients at risk on surgical wards is com-
Implementing these tools facilitates education parable to that described in medical cohorts [52].
and improves clinical results [68]. The United Kingdom’s National Early Warning
Checklists have been widely accepted for peri- Score [47] was found to have similar sensitivity
operative care. Similarly check lists could be used and specificity in surgical and medical patients
for antibiotic choice [69]. The World Health (G. Smith, personal communication).
Organization (WHO) checklists represent a “nor- Two studies have reported data on the effect of
mal checklist” [3]: “Normal” checklists in aviation these interventions: The impact of implementing
are performed as routine procedures to anticipate an Early Warning Score coupled to an RRT and a
complications. Peri-operative checklists can antic- call-out algorithm has been evaluated in a
ipate complications and improve mortality and 6-month before and after study [77]: An RRT saw
peri-operative morbidity. The impact of surgical 273 patients on four surgical wards. The author
checklists is likely to be mediated through engag- reports a reduction in the proportion of emer-
ing the staff’s attention and changes in their safety gency admissions to intensive care from 58 % to
culture: Improved communication, flattening of 43 % with a reduction of mortality in this patient
hierarchies, and better social functioning within group from 29 % to 24 % during the study period.
teams rather than the mechanical ticking of boxes However, detailed data about the patient cohort
[70]. The absence of these social changes in short and inclusion criteria was not reported.
term studies might explain why some trials have A second interventional study of surgical
found little to no improvement in clinical outpatients comes from Australia: A single center 4
comes despite checklist usage [71]. months control and intervention period with just
Adaptive lists can be further used for the over 1000 patients each were compared [78]. A
majority of surgical patients [72]. Crisis check- reduction in both mortality and a broad range of
lists are “emergency checklists” that are only complications including myocardial infarction,
applied during an expected impending catastro- stroke, and acute renal failure were reported.
phe. Experience is currently limited to compli- The rational for the reduction in complications
cations in the operating room [73, 74]. The is not clear. Better renal outcomes might be due
concept can be further developed to improve to more pro-active peri-operative fluid therapy,
standardization or harmonization of care for and this would be expected to be associated with
patients experiencing “MET syndromes” in an increased rate of pulmonary edema and pos-
general wards. sibly myocardial infarction which was not
observed. The complication rate decreased from
vidence for Impact of Rapid Response
E 1 in 3–1 in ten patients. It would be unusual to
Teams in Surgical Patients associate all of these with abnormal MET trig-
The impact of RRTs on outcomes in surgical gers. It is therefore possible to hypothesize that
patients has been largely part of generic evaluation the presence of a Rapid Response practitioner
of RRS [75]. A meta-analysis of published might have triggered discussions about management
literature suggests a reduction in cardio-pulmonary of non- crisis patients with improvements in
arrests and a trend toward improved mortality in complications.
Failure to Repeat care admission. In VITAL I [79] the admission to

ICU increased in US units and fell in Australian
Failure to rescue in clinical practice often occurs units when employing the seemingly same inter-
after an initial successful activation of the chain vention. Decisions to admit to an intensive care
of survival and a transient improvement in unit are variable [86] and might depend on the
patient status. Notably, in patients with complex numbers of intensive care beds and providers
surgical pathology sustained monitoring and re- available [87] and on the availability to provide
evaluation is required. Electronic systems might high levels of care such as ventilation and inotro-
provide more reliable ways to remind clinicians pic support outside intensive care. On the other
of unstable patients. There is some indication hand, it is comparatively easy to time processes
that this might lead to a safer patient environ- from first physiological deterioration to clinical
ment [79–81]. outcomes such as admission to critical care
(“Score-to-Door time” [88]) and this can be used
as a marker of functional processes [89]. The
Failure to System Design financial cost of failure to rescue is often difficult
to measure for individual patients and might only
The design and human factors of systems in hospi- be evident in the comparison of systems with dif-
tals frequently do not follow principles of safe ferent levels of adverse events.
design [82, 83]. High reliability industries rely on There are some limitations to the metrics of
the fact that safety critical steps rely on redundant failure to rescue: cardio-pulmonary arrests might
systems [84]. In case one component or a system not be relevant outcomes for the majority of
(or a member of a team) commits an error other patients. Failure to rescue in patients with
components are able to fully compensate for this advanced cancer or those nearing the expected
error and thus prevent catastrophe [83]. Most high end of life might take different priorities that are
reliability industries employ systems that have in- less easy to measure. It is therefore essential that
built redundancy: safety critical interventions patients at risk of catastrophic deterioration
always exist in duplicate or triplicate [84]. receive a robust assessment by an experienced cli-
Important parts of procedures are being performed nician and a frank and open discussions of likely
by a least two operators following a scripted pro- outcomes of the range of available interventions.
cess of call and re-call [39]. The principle of redun- In this chapter we have focused on the detec-
dancy can be introduced into hospitals on a number tion and prevention of deterioration by analysis
of levels. Computerized alerts for abnormal labora- of abnormal vital signs. These are more difficult
tory tests and vital signs in electronic patient to gauge in patients with chronic conditions such
records can alert staff to deteriorating patients that as chronic obstructive pulmonary disease or con-
were missed by the primary care team [85]. gestive cardiac failure. These patients will often
suffer with abnormal vital signs even in times of
being well. As a consequence reliable care is
Failure to Measure more difficult to define and might require more
complex monitoring interventions. In patients
Establishing safe systems requires defining what with multiple conditions the correct course of
safety “looks like.” The literature on RRS has treatment is also often not immediately obvious.
often focused on reduction of cardio-pulmonary The failure to identify protocols for conditions
arrests (CPA). These have been significantly such as sepsis that work in randomized
reduced over the last decade. While a reduction controlled trials illustrate the importance of clini-
of admissions to intensive care has also been cal decision makers in deciding which treatments
attempted it is less clear whether this is achiev- might be beneficial for a given patient.
able given the variation in judgment on what is an Consultation with colleagues might reduce the
appropriate, bed availability, and timely intensive risk to administer treatments that are harmful.
Conclusions incidence of adverse events among hospital patients in

Canada. Can Med Assoc J. 2004;25:1678–86.
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A Quiet Revolution:
Communicating and Resolving 38
Patient Harm
William M. Sage, Madelene J. Ottosen,
and Ben Coopwood
“Truth never damages a cause that is just.”

—Mahatma Gandhi
Imagine falling ill or being injured, but with a cur- Fortunately, serious injuries from errors in
able condition. You are referred to a successful, surgical care are uncommon. Unfortunately, they
confident, and experienced surgeon. He presents a happen more often than should be the case for an
clear, compelling plan of treatment, which you industry that aspires to high reliability in safe-
gratefully accept. Imagine entering the hospital guarding patients’ lives and health [1–3].
for your operation: the majestic facility, the cut- Inexcusably, their occurrence not infrequently
ting-edge technology, and the skilled, compas- leads to the nightmarish scenario of abandon-
sionate personnel there to care for you. Afterwards, ment described above, a through-the-looking-
however, things are not as you had been led to glass experience reminiscent of buying cheap
expect. But what went wrong, why it happened, consumer goods or taking fraudulent investment
or how to make things better again are withheld advice far removed from how health profession-
from you. There are whispers but no answers. als see themselves and their work. Surveys of
Some people don’t look you in the eye; others physicians confirm that many medical errors,
have simply vanished. Now imagine the same even those causing significant injuries, are not
thing happening to your parent, spouse, or child. disclosed to patients [4–6]. But that is finally
changing—a significant trend in medical practice
and professional ethics that this chapter describes,
W.M. Sage, MD, JD (*) explains, and celebrates.
School of Law and Dell Medical School, University Consider the following not-so-hypothetical
of Texas at Austin, 727 E. Dean Keeton St., Austin, cases:
TX 78746, USA
Case #1 A right hepatic lobectomy for hepato-
M.J. Ottosen, PhD, MSN, RN
Department of Family Health, UTHealth-Memorial cellular carcinoma. The OR shift change occurs
Hermann Center for Healthcare Quality and Safety, during the uneventful, 3-h case, and a new scrub
6410 Fannin, Suite #1100.45, Houston, TX 77030, USA tech and circulating nurse relieve the original
e-mail: [email protected] team. Once the specimen is removed and hemo-
B. Coopwood, MD, FACS stasis achieved, the attending surgeon scrubs out
Department of Surgery and Perioperative Care, Dell to start another case while the surgical fellow
Medical School, University of Texas at Austin, 1501
Red River Street, Austin, TX 78712, USA closes. Sponge and instrument counts are per-
e-mail: [email protected] formed and documented as correct. However, a

650 W.M. Sage et al.
chest x-ray obtained as part of a fever work-up 4 leaders, safety experts, and patient advocates
days later reveals a retained laparotomy sponge. began roughly 20 years ago to change practice
norms to prioritize honesty and transparency fol-
Case #2 A surgical consultation for a patient lowing medical error and are now developing
complaining of intermittent right upper quadrant standards and procedures for comprehensive
pain. The history and exam are consistent with strategies of patient and professional engagement
biliary colic. The patient brings an ultrasound called Communication and Resolution Programs
that was ordered by her primary care physician; (CRPs). In late 2014, the American College of
the accompanying report documents cholelithia- Surgeons adopted a statement on medical liabil-
sis. A laparoscopic cholecystectomy is recom- ity reform concluding that “on balance, disclo-
mended and performed, but the pathology report sure and offer programs, otherwise known as
reveals a normal gallbladder without evidence of communication and resolution programs, show
gallstones. Upon investigation, it is discovered the most promise for promoting a culture of
that the ultrasound had been mislabeled and in safety, quality, and accountability; restoring
fact was that of another patient. financial stability to the liability system; and
requiring the least political capital for implemen-
Case #3 Operative fixation of a right ankle frac- tation” [9].
ture 4 days after admission following a highway-
speed motor vehicle accident. The case had been
delayed to allow resolution of pulmonary contu- Public Policy Underpinnings of CRPs
sions noted on an admission CT scan. Near the
completion of the case, the patient becomes pro- The overarching goal of CRPs is to provide good
foundly hypotensive with a significant rise in patient care, both by reducing the frequency of
peak airway pressure. An emergent transthoracic unanticipated, adverse outcomes and by remedi-
echocardiogram reveals a dilated right ventricle. ating preventable harm that has already occurred.
Despite resuscitative efforts the patient dies in Patients and families should be treated no
the OR, and autopsy shows a saddle pulmonary worse—clinically, emotionally, and financially—
embolus as the cause. Peer review determines after a medical error than before it. Plausibly,
that DVT prophylaxis with low molecular weight they should be treated better. Physicians, nurses,
heparin had not been started on post-injury day and other health professionals also require sup-
one as specified in the institution’s guidelines. port and guidance when things go wrong.
Although they differ in terms of cause, fault, and Improving safety cannot and will not occur
perceptibility by patients and families, these cases all unless all concerned—whether technical experts,
involve serious preventable harm. They also all merit ancillary personnel, or laypeople—have confi-
prompt investigation and full explanation to the indi- dence that the organizations in which they pro-
viduals affected by them [7]. How this communica- vide or receive care are capable of dealing
tion occurs should reflect a deliberate organizational humanely with error.
strategy—informed by research—regarding what Saving money is not a fundamental objective
patients and families need and want, what supports for CRPs. CRPs are designed to be proactive when
the members of the health-care team, and what keeps injuries occur and therefore may end up compen-
patients safe in the future. sating a larger number of patients than has been
The need for a team approach to resolving the case historically. The analytic and communica-
errors is particularly pressing for modern surgery, tion functions of CRPs must happen quickly and
which captures perhaps better than any other spe- must be performed correctly, which often requires
cialty the importance of centering health care on a substantial investment of personnel and other
both individuals and systems, and of delivering resources. On the other hand, cost savings can be a
services that are timely, compassionate, and welcome by-product of CRPs, particularly for
effective [8]. After a long and seemingly inexpli- organizations that self-insure their liability risk,
cable lapse in addressing these issues, clinical because compensation payments tend to be smaller
38 A Quiet Revolution: Communicating and Resolving Patient Harm 651
and more predictable and because total adminis- tors and the public in the form of validated
trative costs tend to be lower. processes and measurable outcomes.
CRPs respond to three major changes in the Third, the structure and financing of health care
public policy context for accountability in health have moved rapidly to an industrial model in
care. First, policymakers understand patient which physicians are increasingly employees or
safety very differently now than two decades close affiliates of hospitals, large practice groups,
ago. Research on medical errors conducted HMOs, or emerging organizational forms such as
mainly in the 1980s and 1990s was brought to the accountable care organizations (ACOs). This shift
attention of the broader public in the Institute of has been characterized by both integration of com-
Medicine’s seminal reports, To Err Is Human and plementary components of production into coordi-
Crossing the Quality Chasm. In addition to nated units and consolidation of small producers
exposing significant lapses in safety and quality, into larger entities. Correspondingly, payment sys-
the IOM reports asserted the centrality of systems in health care are changing to reward “value”
tems thinking and the need for human factors based on cost, performance metrics, and improve-
engineering, which substantially reoriented the ments in population health. CRPs are consistent
established, individually oriented paradigm for with this move toward organized systems of care,
medical quality assurance even if it did not many of which emphasize interprofessional prac-
wholly supersede it. CRPs embody this commit- tice and shared accountability, and the more inno-
ment to safety redesign, including gathering vative of which offer bundled treatment at a unit
information, analyzing it, and feeding it back to price, sometimes with a warranty against addi-
those who can use it to improve care. tional costs should unanticipated problems arise.
Second, informational accountability has pro-
liferated not only in health care but also generally
as a regulatory strategy for government [10]. In Communication-and-Resolution
medicine, ethical and legal requirements of infor- Essentials
mation disclosure respond to asymmetries that
have long skewed treatment relationships to Designing and implementing a successful CRP
favor health-care providers and health insurers requires a committed institution, actively engaged
and that often have compromised both patient health-care professions, and a suitable legal and
autonomy and consumer sovereignty. regulatory environment. There are seven core
Information-based regulation is even more com- commitments for organizations and their clini-
mon today because the Internet and mobile com- cians [11]:
munications have so dramatically expanded and
democratized information and because our • Being transparent with patients around risks
increasingly partisan political process regards and adverse events
disclosure as a palatable compromise between an • Analyzing adverse events using human factors
unrestrained market and direct government con- principles
trol. We therefore rely more on informed consent • Supporting the emotional needs of the patient,
to empower individuals in their treatment deci- family, and care team
sions, impose more obligations for providers and • Proactively and promptly offering financial
insurers to report information to regulators, and and nonfinancial redress when care was
enact broader mandates for direct disclosure to unreasonable
the consuming and voting public—all under the • Educating patients about their right to seek
umbrella term “transparency.” CRPs honor this legal representation
movement by offering patients and families • Working collaboratively with other providers
information that dignifies their personhood and and liability insurers when adverse events
facilitates their decision-making, while building involve multiple parties
a knowledge base of professional and institu- • Assessing continuously the effectiveness of
tional experience that can be conveyed to regula- the CRP program
Assuming these commitments are in place, patient and family, usually represented by coun-
one can specify a basic sequence of steps that sel, to discuss the overall experience, finalize
are necessary to the resolution of medical injury compensation where appropriate, and discuss
[11]. safety improvements that have been instituted or
The CRP process begins with an initial that are anticipated. The final step in successful
response to the patient (or family) and the care- CRP engagement is to obtain feedback about the
giver when an unanticipated outcome of care process from all of the individuals who were
occurs. This includes reporting the event to the involved in it.
organization and meeting each party’s immediate
medical and emotional needs. The initial response
is followed by early collaboration among the I nvolving Patients and Families
health professionals and institutional representa- in Safety Improvement
tives to access and organize the available infor-
mation and to formulate a plan for discussing the Patients and families who experience preventable
situation with the patient and family [12]. harm generally have a desire to partner with their
These two steps lead promptly to an initial clinicians and the health-care organization in
communication with the patient and family understanding what happened and preventing
regarding what is already known, what is not yet recurrences [16, 17]. However, they are often left
known, what their emerging needs are and how out of the process [18].
they might be met, and what the next steps in the Eliciting patient and family perspectives on
process will be. Apologies of sympathy or of the harm supports the CRP process in three ways:
responsibility may be offered, as appropriate; (1) by helping identify causes that only the
however, compensation for injury may or may patient and family may know, (2) by offering rec-
not be discussed. Overall, the conversation ommendations to improve patient-centered qual-
should be factual, sensitive to patients’ and fami- ity of care, and (3) by promoting their emotional
lies’ circumstances, and customized to match healing. In surveys, patients and families who
their preferences [13]. Patients and families need suffered harm reported that knowing that their
time to process news of the harm, reflect with one narrative would be acknowledged in the event
another, and deal with feelings of loss. Depending analysis and would help guide preventative
on the severity of the harm, patients and families efforts made them feel valued [19–22]. They
may be angry or disbelieving and may feel par- described interaction with the hospital as
ticularly vulnerable if they are still receiving care fundamental to emotional healing, post-event

from the organization where the harm occurred support, and maintaining confidence in their
[14, 15]. Nonetheless, patients and families want medical care [23].
to have open conversations with their clinicians, The CRP process can be designed to align
usually with multiple interactions. patient and family communication with formal
Having initiated the CRP, the next phase con- safety analysis of the harmful event (Fig. 38.1).
sists of event review, employing the investigative When the patient and family are initially given
and analytic tools of the organization but also the news that harm occurred, they can be invited
maintaining active communication with the to think about what transpired. Eliciting patient
patient and family, eliciting their perspectives, and family input on multiple occasions and by
and incorporating their ideas into the patient multiple persons lets them know that the desire to
safety workflow. Event review should lead obtain their feedback is real. Because patients
directly into quality and safety improvement and families may not remember the specific
actions to be taken both by the individual profes- things said to them during the emotion of the ini-
sionals who were involved and by the system of tial disclosure conversation, repeated attempts
care. After this has been done, the timing may be for follow-up should be made unless they ask not
right for a resolution conversation with the to be approached, and they should always have
current information about whom to contact in the options available and have patients and family
health-care organization if they wish. members choose among them.
Patients and families can be interviewed infor- An interview is preferable to a written survey
mally, be sent a written survey about the events because it allows an exchange of information and
they experienced, be included in the formal root ideas. In developing a set of structured questions
cause analysis, be invited to discuss their for patients and families, institutions should
experiences during patient safety training pro- choose a format that allows them to tell their sto-
grams, or be asked to join a patient and family ries, identify specific causative factors they
advisory council on quality improvement. observed that might be prevented, and share rec-
Institutions with strong patient and family ommendations they may have for improving
engagement programs may make several of these health care in the institution. Beginning with
Fig. 38.1 Opportunities for patient and family engagement after a harmful event
open-ended questions gives patients permission alized and costly [24]. The legal domain
to share the things most impactful to them. principally responsible for erecting barriers to
Following up with more focused questions helps effectively communicating and resolving medi-
patients remember other issues they may have cal errors is medical malpractice law, which con-
identified, such as staff attitudes or handwashing tinues to influence physician perception and
practices. behavior to a far greater extent than an unbiased
The best person to carry out the interview observer would predict given its actual frequency,
depends on the situation. An objective facilitator outcomes, or expense [25].
who is trusted by the patient and family is often An overtly adversarial system that targets indi-
advisable. If the harm was serious, such as a vidual physicians and thrives on secrecy, expense,
patient’s death, this role may be best filled by a and delay, medical malpractice litigation does
mental health professional trained in critical none of the things that CRPs seek to accomplish
incident management or in the support of per- [26]. Civil liability for medical negligence has
sons experiencing such events. Interviewers always represented an imperfect solution to the
should be aware that patients and families may problem described years ago by Gold of “holding
not be ready to tell their full story during a first experts accountable to non-experts” [27]. In an
interview, may need to stop or take a break, and unmeasured world of professional judgment and
may need to have someone with them for emo- discretion, contextual decisions by local judges
tional support. and juries based on a “standard of care” that was
determined by professional custom and intro-
duced into evidence by the testimony of other
he Long Shadow of Medical
T physicians seemed reasonable. Almost from the
Malpractice Liability outset, however, this approach evoked visceral
opposition from the medical profession because
CRPs represent a significant advance over cur- the setting and language suggested a criminal pro-
rent practice with respect to medical injury, ceeding, monetary damages with a hefty cut paid
which is seldom timely, compassionate, transpar- to plaintiffs’ lawyers smacked of blackmail, both
ent, or preventative. The United States expends patients and their testifying experts seemed to be
over $3 trillion annually on health care, far more engaged in acts of betrayal, and final decisions on
per capita than any other nation, and the high sta- clinical matters rendered by laypeople lacked
tus and economic prosperity of American physi- legitimacy in physicians’ eyes.
cians reflect their careful selection, intense As medicine grew in sophistication and expense,
training, and ethical commitment. Why this mas- malpractice lawsuits became a greater threat to
sive investment has yielded so few dividends in physicians and a more formidable obstacle to hon-
terms of effectively responding to avoidable esty about error [28, 29]. Fragmentation of care
injury is an important question, which could also delivery among professional and institutional pro-
be asked about the safety, quality, and value of viders led plaintiffs’ lawyers in search of defen-
US health care more generally. If the goals are dants with deep pockets, to which potential
self-evident, and the methods for reaching them defendants responded with concealment or finger-
relatively clear, why have we not already pointing. As “captains of the ship,” physicians were
achieved greater success? forced to bear considerably greater financial
Surprisingly often, the answer to such appar- responsibility for health system failings than their
ent paradoxes is that a century-long accumula- earnings could reasonably support. The solution,
tion of legal and regulatory constraints that third-party liability insurance, in many ways com-
originally were intended to reinforce physician pounded the failings of the malpractice system by
professionalism has ended up frustrating sound regarding patients as both strangers and adversar-
policy design as health care became more techni- ies, as well as by creating a new political interest
cally sophisticated and necessarily more industri- group to question the veracity of malpractice plain-
tiffs and lobby for legislative restrictions (“tort an ethical and legal obligation in advance of sur-
reform”) whenever insurance premiums rose. gery or other procedures. If physicians are obli-
Protecting and managing personal informa- gated to tell patients about bad things that might
tion has always been a central aspect of preserv- happen, how can physicians conceal information
ing reputation [30]. Because allegations of about bad things that did happen? Yet informed
medical malpractice were so entwined with phy- consent is not generally understood to encompass
sicians’ professional and personal reputations, error disclosure. Even worse, some physicians
publicity about possible errors (which often took incorrectly believe that informing a patient about
the form of malicious gossip rather than objective a potential complication absolves them from
proof) was fraught with peril. Silence when error fault if that complication occurs, regardless of
was unsuspected by patients, and quiet settlement whether the particular occurrence was prevent-
when error was self-evident, therefore became able. Fourth is confidentiality in the settlement of
the modus operandi of many malpractice defen- malpractice lawsuits. Settlement was only in
dants. This resistance to sharing information physicians’ reputational interest if it was done
about medical errors has carried over to the mod- quietly (something that the National Practitioner
ern era of clinical practice in several ways, each Data Bank and mandatory reporting to state
of which CRPs must confront and overcome if licensing boards has made more difficult). As a
they are to succeed. result, settlement agreements typically prohibit
First is the increased diversity of parties in claimants and their lawyers not only from publi-
whose good graces physicians must remain, cizing the amounts received or disparaging the
which used to be limited to colleagues who physicians involved but also from discussing the
referred them patients, malpractice insurers, and circumstances of the care received—a bitter pill
state licensing boards. Relevant constituencies for patients and family members seeking valida-
now include hospitals, health insurance networks, tion of their experiences and protection for future
and various other contracting partners, as well as patients [31].
Internet-based rating systems which patients and On the other hand, the dark cloud that hangs
competitors can manipulate instantly and cost- over effective communication and resolution of
lessly to harm physicians’ reputations. Second is errors because of medical malpractice contains a
the paradoxical way in which some physician few silver linings for CRPs. Physicians fear mal-
groups and malpractice insurers have responded practice suits in part because they feel unable to
to new knowledge about the frequency of medical control them; tort reform, for example, requires
errors. After decades hearing such groups assert sustained political engagement and costly cam-
that lawsuits should be curtailed because few phy- paign contributions and can be undone by state
sicians committed errors, one might have expected constitutional courts even if legislatures and
revelations that errors are in fact common to cause governors remain sympathetic. By contrast, the
some backpedaling. To the contrary, many of decision to be honest with a patient, and quite
these stakeholders redoubled their efforts to possibly to defuse a potential lawsuit, is fully
secure tort reform, arguing that only if physicians within each physician’s individual control.
are protected from litigation and its associated Transparency coupled with early resolution has
publicity will they report problems internally and even greater advantages relative to conventional
work collectively to improve patient safety. When litigation: less anxiety and hostility, less time
Pennsylvania in 2003 became the first state to away from one’s medical practice, quicker anal-
mandate disclosure of serious adverse events, for ysis with greater opportunity to implement
example, many health-care providers and mal- safety improvements, and perhaps the chance to
practice insurers dismissed it as a trick of the trial avoid mandatory reporting of a settlement to a
lawyers designed to gin up additional business. licensing board or the national data bank, with
Third is informed consent, which is well its associated blemish on one’s professional
accepted by recent generations of physicians as reputation.
From Error Disclosure to CRPs (averaging $190,113 per year), and the average
payment per claim was $15,622. Compared to 35
The move toward CRPs began voluntarily in a similar VA hospitals, disclosure and apology sug-
few institutions as early as the 1980s, expanded gested a financial advantage for full disclosure
and acquired support from professional associa- [35]. A follow-on study with 12 years of data
tions and regulatory bodies in the early 2000s, showed an average of 14 settlements per year
and became more systematic following the enact- totaling $215,000 – averaging roughly $15,000
ment of the ACA in 2010. Leaders in early settle- per settlement, compared to the mean VA system
ment models include the Veterans Health System, settlement in 2000 of $98,000 [36].
several self-insured academic institutions Based largely on the Lexington VA experi-
(Michigan, Illinois, Harvard, Stanford), and ence, the Department of Veterans Affairs adopted
some nonprofit hospital groups (Catholic in 1995 a policy requiring all its medical centers
Healthcare West, Ascension Health), while non- to inform patients or their families when medical
captive liability insurers (COPIC, Coverys, West errors result in injury, to offer appropriate medi-
Virginia Mutual) have pioneered limited com- cal treatment, and to advise them of their right to
pensation models not requiring release of legal file a claim. In 2005, the Veterans Health System
claims or reporting to the National Practitioner issued a national directive titled “Disclosure of
Data Bank [32–34]. Patient advocacy groups also Adverse Events to Patients.” This policy has been
embraced transparency following error, notably renewed and improved several times [12, 37].
the SorryWorks! Coalition, which urged hospi- The Veterans Health System has important
tals to be honest with patients as a compassionate advantages in its CRP operations, including
obligation and a sound customer relations strat- employed physicians, “enterprise liability” for
egy more than for litigation risk management or malpractice defined and limited by federal stat-
patient safety. With leadership from the federal ute, exemption from many state laws, and the
Agency for Healthcare Research and Quality ability to enter into memoranda of understanding
(AHRQ), which began funding demonstration with other federal agencies and to define its own
projects and developing consensus standards in legal standards for evaluating the cause of patient
2010, the focus shifted from simple disclosure of injuries and reporting individual but not system-
error, often with apology, to a structured process based settlements to the National Practitioner
of patient engagement, compensation, and safety Data Bank [37].
improvement.
arly Resolution: University of Michigan
E
and University of Illinois – Chicago
Pioneers and Early Adopters In 2002, the University of Michigan Health System
(UMHS) launched a comprehensive claims man-
isclosure and Apology: Veterans
D agement model with disclosure as its centerpiece.
Health System Its core principles, articulated by system counsel
In 1987, the Veterans Affairs Medical Center in Richard Boothman, were as follows: “We will pro-
Lexington, Kentucky, in response to losing two vide effective and honest communication to
malpractice judgments totaling more than $1.5 patients and families following adverse patient
million, instituted a radical policy of apologizing events; we will apologize and compensate quickly
to patients as soon as possible after the occur- and fairly when inappropriate medical care causes
rence of a medical error, giving a full explanation injury; we will defend medically appropriate care
of the cause and the steps taken to prevent future vigorously; and we will reduce patient injuries and
harm and, when appropriate, offering a fair set- claims by learning from the past.” The model,
tlement. Between 1990 and 1996, 88 malpractice which applies an expert construct of “reasonable”
suits were filed of which only one proceeded to care rather than a legal standard of negligence, was
trial (and was won by the government). A total of associated with a sharp decline in the number of
$1,330,790 was paid out over the 7-year period new claims against UMHS from 121 in 2001 to
61 in 2006 [38, 39]. The model also reduced the Program (“Recognize, Respond, Resolve”) [42].
average claim processing time from 20.3 months Within 72 h of a complication or injury to a
to roughly 8 months. This had the effect of decreas- patient, the 3Rs Program enables the physician
ing the number of open claims from 262 in 2001 to and patient to engage in open, honest, empathic
83 in 2007, dropping required insurance reserves conversation. In cases in which no lawyer is
by two thirds and more than halving litigation involved and which are unlikely to incur large
expenses. damages, COPIC offers patients immediate,
Drawing on the Michigan approach, the unconditional compensation for out-of-pocket
University of Illinois Medical Center at Chicago losses, which are capped at $50,000. Within 5
(UIMCC) in 2004 began to implement a compre- years, 65 % of COPIC-insured physicians in pro-
hensive process for responding to patient safety cedurally based specialties and 28 % of other
incidents with “seven pillars”: physicians were enrolled in the program. As of
Report incidents that could harm patients; investi- October 2006, 2853 Colorado physicians had
gate those cases and fix problems before an error enrolled, and the program had handled 3200
happens; communicate when an error occurs, even events involving disclosure of medical errors. Of
if no harm was done; apologize and ‘make it right’ these events, 25 % of patients received payments
by waiving hospital and doctors’ fees; fix gaps in
the system that can cause things to go wrong; track at an average of $5400 per case. Of the cases in
data from patient safety reports and see if changes which compensation was paid (roughly 800
make things safer; and educate and train staff how cases), seven cases proceeded to litigation with
to make care safer. [40] two resulting in tort compensation. Of the cases
without compensation paid (roughly 2400 cases),
UIMCC emphasized teaching young physi- 16 proceeded to litigation with six resulting in
cians to report and analyze unsafe conditions and tort compensation.
providing “care for the caregiver” when injuries
occur. In the first 2 years, the process doubled the
number of safety incidents reported, prompted Broadening Consensus
more than 100 investigations with root cause
analysis, generated nearly 200 system improve- elf-Regulatory and Professional
S
ments, and served as the foundation of 106 dis- Bodies
closure conversations and 20 full disclosures of Organizations directly concerned with the quality
inappropriate or unreasonable care causing harm of medical care became supportive of error com-
to patients. A 2012 UIMCC communication to munication early in the 2000s. In 2001, The Joint
AHRQ updating the program’s results showed a Commission adopted a standard requiring a lim-
continued increase in patient safety reporting to ited form of error disclosure, involving “unantici-
7500 incidents per year, with a 50 % decrease in pated outcomes of care,” as a condition of facility
new claims filed by patients and a reduction in accreditation. The Institute of Medicine offered
median resolution time from 55 months prior to liability reform based on CRP principles as a
program implementation to 12 months afterwards “Rapid Advance” recommendation to the
[32]. A later article noted that the initiative Department of Health and Human Services in
seemed to have significantly slowed the practice 2002 [43]. The Joint Commission’s Tort
of defensive medicine, reducing the rate of Resolution and Injury Prevention Roundtable
growth in clinical lab orders by 24 % and radiol- issued a white paper endorsing transparency in
ogy orders by 18 % [41]. conjunction with a CRP-type approach to com-
pensation and safety improvement [44]. In 2006,
imited Compensation: COPIC
L the National Quality Forum included full disclo-
In 2000, the physician-owned medical profes- sure of “serious unanticipated outcomes” among
sional liability insurer in Colorado, COPIC its 30 “safe practices” for health care and promul-
Insurance Company, launched a post-incident gated disclosure standards as guidance for
risk management program called the 3Rs physicians and hospitals [45].
Medical professional associations were some- event, occurrence or situation involving the clini-
what slower to follow because of the difficulty cal care of a patient in a medical facility that
disentangling commitments to honesty and results in death or compromises patient safety
improvement from concerns over malpractice and results in an unanticipated injury requiring
liability, particularly during the liability insur- the delivery of additional health care services to
ance crisis of that time. In 2003, the AMA’s the patient” (Pennsylvania MCARE Act, 2002 40
Council on Ethical and Judicial Affairs issued a P.S. § 1303).
report explaining physicians’ ethical obligations The Pennsylvania statute triggered efforts by
to study and prevent error and harm [46]. Opinion the state medical society and hospital association
8.21 of the AMA’s Code of Medical Ethics reads: to provide communication guidance to their
Physicians must offer professional and compas- members, as well as a substantial research effort
sionate concern toward patients who have been funded by the Pew Charitable Trusts. The
harmed, regardless of whether the harm was researchers recommended four measures to cre-
caused by a health care error. An expression of ate a culture that supports candor, the free
concern need not be an admission of responsibility.
When patient harm has been caused by an error, exchange of information, fair outcomes for
physicians should offer a general explanation patients and physicians, and improved patient
regarding the nature of the error and the measures safety—all mainstays of CRPs today [48]. These
being taken to prevent similar occurrences in the were to provide communication skills training to
future. Such communication is fundamental to the
trust that underlies the patient-physician relation- physicians and other health-care professionals to
ship, and may help reduce the risk of liability. prepare them for disclosure conversations, to cre-
ate a consult service of expert communicators
The American College of Surgeons has not among the hospital’s professional staff who can
included error disclosure in its code of ethics but help plan and conduct disclosure conversations
stated in a recent report on medical liability with patients and families and provide debriefing
reform and safety improvement that “Adverse and emotional support to the health-care provid-
events should be approached with open commu- ers involved, to apologize when appropriate and
nication and recognition that an unfortunate attend to the form of apology (sympathy versus
outcome is not synonymous with negligence.
responsibility) most likely to be helpful in restor-
Compensation for injured patients, monetary or ing trust between the patient and physician, and
otherwise, should be fair and timely without the to use facilitative mediation techniques to resolve
unnecessary delay commonly associated with the claims promptly, possibly before a lawsuit is filed
current tort process” [9]. Similarly, the Institute [49, 50].
of Medicine has renewed its endorsement of error Simultaneously with the Pennsylvania law,
disclosure and specifically recommends that Tennessee required disclosure to patients of
states encourage the development of CRPs [47]. “unusual events” that were made reportable to
the state department of health. Shortly thereafter,
tate Laws
S Nevada, New Jersey, and Florida imposed
State laws requiring disclosure to patients of requirements that patients be notified in person
medical errors were a novel and important part of (rather than in writing) by the medical facility
the legislative response to surging malpractice after any event that causes serious injury [51].
insurance premiums nationally in the early 2000s, The Florida statute specified that notification of
not long after the IOM reports thrust patient adverse incidents did not constitute an admission
safety onto the national health policy agenda. In of liability and could not be introduced as evi-
2002, Pennsylvania enacted a heavily negotiated dence (Fla. Stat. § 395.1051, Nev. Rev. Stat. §
set of malpractice reforms, including the first 439.835, N.J. Stat. § 26:2H-12.25). Over the next
state law duty on hospitals to notify the patient or few years, laws mandating error disclosure were
patient’s family in writing within 7 days of a also enacted in Oregon, Vermont, California, and
“serious event,” which the statute defines as “(a)n Washington, while South Carolina, Connecticut,
and Maryland instituted limited disclosure obli- and about 2000 caregivers, in a malpractice cli-
gations by administrative rule. A significantly mate that is relatively favorable to health-care
larger number of states shield medical apologies providers [13].
from being used in court as evidence of fault, Ascension Health System’s Excellence in
although the scope and impact of these laws vary. Obstetrics Project has enrolled more than 23,000
mothers and infants at five demonstration project
sites to test the effects on clinical outcomes and
Recent Developments liability claims of improved obstetrician and nurs-
ing teamwork, a standardized electronic fetal
AHRQ Demonstration Projects monitoring curriculum, a shoulder dystocia best
Policy proposals advocating disclosure as a key practice “bundle,” and a coordinated open commu-
element of patient safety and dispute resolution nication and resolution process known as CORE
moved into the national political arena slowly [57]. University of Illinois Hospital’s Improving
[52]. Early in the Obama administration, the Communication with Patients Project entails fur-
President announced in a speech to Congress ther refinement of the “seven pillars” approach
intended to generate bipartisan support for health along with implementation of the program at ten
reform that the Department of Health and Human private Chicago-area hospitals with open medical
Services would fund the liability demonstration staffs and multiple liability carriers, also in a chal-
projects that the IOM had recommended to the lenging malpractice climate. Building on earlier
Bush administration in 2002 [53]. As a result, work at the Harvard hospitals, the Massachusetts
AHRQ awarded $23.2 million in 2010 for nine Alliance for Communication and Resolution
large efforts to combine patient safety improve- Following Medical Injury (MACRMI) created a
ment with innovations to reduce liability costs, road map for transforming the state’s medical lia-
five of which involved CRPs, and for two smaller bility system, established a statewide model
planning grants [54, 55]. The AHRQ demonstra- known as the Communication and Resolution
tions partner leading academic researchers with (CARe) Program, and launched CRPs in eight
other stakeholders in order to expand CRPs to Massachusetts hospitals that have handled more
broader community settings, encourage public- than 850 patient safety cases [58, 59].
private collaborations, and engage patients in
safety improvement. CandOR Toolkit and Collaborative
Launched in a volatile malpractice environ- for Accountability and Improvement
ment, the New York State Patient Safety and Although empirical results from the AHRQ
Medical Liability Reform Project works with the demonstration projects are still forthcoming,
state’s Office of Court Administration (OCA) and AHRQ decided to build on the positive momen-
five New York City hospitals to provide commu- tum by awarding a $3 million contract to the
nication training, establish a CRP for general sur- American Hospital Association’s educational
gery, and implement a judge-directed settlement arm, HRET, to develop a CRP toolkit akin to
program for all malpractice lawsuits [56]. In the the toolkits it has developed in other quality
Washington State “HealthPact” project, a liabil- and safety areas such as TeamSTEPPS. The
ity insurer and 11 health-care institutions are toolkit, named Communication and Optimal
attempting to implement CRP models statewide, Resolution (CandOR), was piloted at 14 hospi-
working with plaintiff attorneys, patient advo- tals in three large health systems (MedSTAR,
cates, and regulators such as the state medical Dignity Health, and Christiana Care). As with
licensing board. The Project on Patients as the demonstration projects, implementation
Partners in Learning from Unexpected Events is and evaluation proved challenging given the
being conducted in the University of Texas short time frame. The toolkit was released to
System, which consists of six health campuses the public in the spring of 2016.
After 2 years of planning, the Collaborative omnipresent risk. Therefore, leadership is the key
for Accountability and Improvement was attribute of successful CRPs from an institutional
launched in December 2015. The Collaborative perspective—operational leadership from the
brings together pioneering CRP institutions and general counsel or chief quality/safety officer and
key stakeholders such as liability insurers, patient unequivocal endorsement by the chief executive,
advocates, and researchers to pursue three pri- deans/department chairs, and board of trustees.
mary goals: to accelerate the adoption of CRPs Strong leadership is also necessary to assure suf-
nationally and internationally by identifying and ficient resources. In conventional litigation, risk
disseminating best practices, to foster a support- management, fact-finding, analysis, outreach,
ive state and federal policy environment, and to reconciliation, and improvement are either done
create a shared space for learning and innovation. slowly or not done at all. CRPs must perform
The Collaborative applies a “Just Culture” frame- these functions not only well but also quickly,
work to CRP design, integrating multiple princi- which requires a substantial investment in per-
ples from ethics, management, and safety science sonnel and support services.
to create a framework and algorithms that link Institutions that self-insure malpractice risk or
institutional response to the level of clinician use a captive liability insurer are better posi-
responsibility for adverse events. Just Culture is tioned to launch a CRP, as are institutions that
based on the core human factors observation provide coverage to their employed and affiliated
from high-reliability industries that the first prin- physicians, because they can more easily present
ciple of safety improvement is driving out fear a unified response to injury, integrate patient care
[60, 61]. Although the application of Just Culture and legal functions, and capture savings directly
requires complex, value-laden judgments, the within clinical departments. Even in these orga-
preferred response to human error is to console nizations, however, it is important for risk man-
and the preferred response to at-risk behavior to agement and billing practices to be coordinated
coach, leaving punishment only for behavior that with the CRP process. For example, patients may
is deliberate or reckless. need encouragement and assistance finding legal
counsel to represent them, which seems counter-
intuitive but benefits CRPs in the long run.
Individual, Institutional, Settlement should be consistent with the goals
and Environmental Optimization and ethics of CRPs, with confidentiality provi-
sions limited to the parties’ legitimate interests in
CRPs operate successfully in many geographic avoiding disparagement and not attracting merit-
locations, organizational settings, and clinical less claims [31]. In addition, institutions should
situations, but implementing a CRP is not easy. develop systems that ensure that all medical bills
Experience to date suggests important lessons for from care that resulted in injury are waived or
health-care institutions, individual health profes- held pending resolution; ideally, these efforts
sionals, and state and federal policymakers, should extend to bills from unaffiliated physi-
attention to which can help CRPs accomplish cians who were not at fault.
their goals [62].
Individual Professionals
Institutions
Physicians, nurses, and other professionals must
Because many health-care organizations are large have sufficient confidence in an organization’s
bureaucracies with habituated practices, over- commitment to Just Culture to overcome their
coming inertia requires dislodging long-held fears of reprisal and reputational damage. Indeed,
assumptions and prejudices regarding medical causing harm to one’s patient is a traumatic event
injury and its aftermath, and backsliding is an for every health-care professional, and “care for
the caregiver” is a core function of any successful cases to refer to CRPs because they are admitting
CRP. As with the patient and family, these inter- fault. Because safety improvement is a critical
ventions should begin promptly but may be aspect of CRPs, an important issue in all jurisdic-
needed over a protracted period. Health profes- tions is whether information gathered and shared
sionals should recognize that CRP engagement is by CRPs receives legal protection from discovery
a process, not a single, discrete event. and use in litigation—either because of immuni-
Having individual physicians participate fully ties granted patient safety organization under
in communication and resolution activities federal law or because of state-specific legal
encompasses four key responsibilities, which can standards.
serve as indicators of a smooth transition from The professional disciplinary response from
conventional approaches to a CRP. First, physi- state licensing boards is the most important
cians in a CRP should promptly and fully report source of potential regulatory incompatibility for
to their organizations any unanticipated clinical CRPs. Physicians and nurses involved in avoid-
events that may occur (both injuries and near able injuries and even near misses worry that
misses). Second, physicians should proactively licensing boards will take a punitive approach to
access available training in how to communicate cases resolved by CRPs rather than adhering to
with patients and families should the need arise, Just Culture principles. Mandatory reporting of
as well as regarding other aspects of the CRP settlement payments, both to state boards (some
[63]. Third, physicians who find themselves in a of which make information publicly available)
situation requiring communication should seek and to the National Practitioner Data Bank
assistance from the CRP’s disclosure support (access to which is limited to government enti-
team before engaging patients or families in ties), also raises concerns among physicians.
detailed conversation. Finally, once the CRP has Some CRPs assert that their payments are not
assumed primary responsibility for resolving a based on individual fault and therefore need not
patient’s situation, the physicians involved in the be reported, but legal authority for that position is
event should not disengage, but should remain questionable. In terms of payment rules, increas-
part of the settlement process. ingly stringent standards and complicated pro-
cesses allowing Medicare to recoup care costs
relating to malpractice settlements can alter the
Legal and Regulatory Environment economics of CRPs for both patients and provid-
ers, as might the continued expansion of insurer
In addition to institutional and individual attri- nonpayment policies for care associated with
butes, the legal and regulatory environment is a harm.
significant predictor of CPR success [64]. The Several states have changed their laws to facili-
legal and regulatory environment relevant to tate CRP implementation. The AHRQ demonstra-
CRPs has three parts: the civil justice system, tion project in Massachusetts spearheaded the
which sets the rules for private accountability; adoption in 2012 of CRP-enabling legislation that
the professional disciplinary system, which sets established a 6-month pre-litigation notification
the rules for public oversight; and the payment requirement, with sharing of all pertinent medical
system, which sets the financial incentives. records, enhanced apology protections, and set
CRPs have been implemented successfully in guidelines for disclosure of unanticipated out-
states with a range of litigation environments, comes. Iowa passed comprehensive CandOR leg-
although both extremes can be challenging. In islation that took effect July 1, 2015, conferring
Texas, with strict tort reform, it is harder to inter- extensive protections on CRP processes and
est health-care providers in trying CRPs because declaring payments made through the CRP
the background risk of litigation is low. In exempt from reporting to the Iowa Board of
New York, with virtually no tort reform, health- Medicine. In Washington, the Medical Quality
care providers tend to be cautious about which Commission issued guidelines affirming Just
Culture principles and endorsing a certification 2. Classen DC, et al. ‘Global trigger tool’ shows that
adverse events in hospitals may be ten times greater
program that would enable CRP resolutions to be
than previously measured. Health Aff. 2011;30:
regarded favorably by the licensing board [65, 581–9.
66]. Perhaps the most important statewide initia- 3. James JT. A new, evidence-based estimate of patient
tive has occurred in Oregon, which launched a harms associated with hospital care. J Patient Saf.
2013;9:122–8.
statewide early disclosure and resolution program
4. Blendon RJ, DesRoches CM, Brodie M, Benson JM,
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Practitioner Data Bank recently reaffirmed its Herrmann MJ, Steffenson AE. Views of practicing
established position that all settlements, including physicians and the public on medical errors. N Engl J
Med. 2002;347:1933–40.
in CRPs, that involve a written demand for pay-
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ment are reportable and failed to clarify whether Levinson W. Patients’ and physicians’ attitudes
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Campbell EG. Survey shows that at least some physi-
cians are not always open or honest with patients.
Conclusion Health Aff. 2012;31(2):383–91.
7. Gallagher TH, Bell SK, Smith KM, Mello MM,
McDonald TB. Disclosing harmful medical errors to
Communication and Resolution Programs repre-
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medical error. Closer to the bedside, farther from and drawbacks for patients and clinicians. In: Clarke S,
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more focused on system improvement, more 9. American College of Surgeons. Statement on medical
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It’s My Fault: Understanding
the Role of Personal Accountability, 39
Mental Models and Systems
in Managing Sentinel Events
Elizabeth A. Duthie
“Accountability for decisions without understanding the context is a form of blame.”
ignoring individual accountability [6–9]. They

Introduction propose that answering the question “is it the sys-
tem or the individual?” as essential to ensuring
The Institute of Medicine (IOM), in 2000, advo- individual accountability is appropriately
cated shifting the focus from the individual to the invoked [10]. The prevailing wisdom is that if the
system when managing adverse events [1]. individual’s actions are the source of the adverse
Healthcare’s embrace of a systems approach for event, individual accountability or sanctions are
managing human error has proven a heavy lift for warranted. If the system is at fault, focusing on
a multitude of reasons. One of those reasons is the individual’s performance isn’t necessary and
physicians and nurses strongly value individual may be counterproductive [9]. The focus for this
autonomy and accountability [2, 3]. Personal chapter is on understanding the impact of sys-
responsibility and the emphasis on error-free care tems on decision-making and the role of root
(first do no harm) are deeply embedded in the cause analyses in achieving sustainable safety
educational preparation for both professions. and reliable progress. The following composite
Experts have noted that professionals, with case is presented to illuminate the issues.
expectations of nothing less than perfection in
their own performance, are prone to self-assign
blame when patient harm occurs [2–5]. Long The First Story: What Happened
after the IOM’s pronouncement, these entrenched
beliefs are contributing to an ongoing struggle to On Tuesday the ORs start an hour later than usual
find the right balance between system redesign to allow time for learning from grand rounds. But
and individual accountability [6–9]. for the staff in OR 3M at The Continually
Within a decade of the IOM report, patient Improving Medical Center (TCIMC), there would
safety experts began asking if a system focus was be no learning. The risk management team had
degrading patient safety by inappropriately summoned them to a root cause analysis (RCA)
meeting. Dr. Kelly Stone had never attended one
of these sessions before but he knew they had a
bad reputation. The RCA was frequently referred
E.A. Duthie, RN, PhD (*) to as root canal without anesthesia. He had been
Patient Safety Resource Center, Montefiore the anesthesiologist in OR 3M when catastrophe
Medical Center, 111 East 210th St, Bronx,
NY 10467, USA had struck. It was now being called a sentinel
e-mail: [email protected] event. The OR 3M team was living in the land of

666 E.A. Duthie
uncertainty as hope that the patient would recover fully intubated Evelyn but only on the third
still loomed large. But Kelly was less hopeful. It attempt using a glide scope. The surgical proce-
had been 18 min between Evelyn’s own breath dure was uneventful and the surgeon left the OR
and the one supplied through the surgical airway. to speak with Evelyn’s husband, while the resi-
The surgeon, surgical resident, scrub technician, dent completed the case.
circulating nurse, the nurse manager, the resusci- When Kelly extubated Evelyn, she immedi-
tation team physician, and the otolaryngology ately started thrashing around, grasping her
resident joined Kelly in the small windowless throat while attempting to sit up. Kelly struggled
conference room. The risk manager, Catherine unsuccessfully to assist her. He told the nurse to
Parker, arrived with the surgical critical care get a stretcher. It arrived in an instant from the
intensivist, the designated expert, and the team corridor immediately outside of the OR door.
leader. There weren’t enough chairs so Catherine Evelyn followed the directions to move onto it,
stood at the front of the room. She announced the inadvertently disconnecting the monitoring
meeting goal was to create a time line of what had leads. Sitting upright did nothing to relieve her
happened to the patient. The follow-up meetings distress. In less than a minute Evelyn stopped
would ascertain why, despite everyone’s best breathing and lost consciousness. Kelly
efforts, things had gone so terribly wrong. instructed the staff to summon the resuscitation
Catherine said: “The focus isn’t on any one indi- team. He couldn’t reach Evelyn to intubate her
vidual, but rather the systems that allowed the as the robot blocked his way. He asked everyone
event to transpire. There will be no blame. The to help return her to the OR table. The four of
starting place is in the telling of the story.” them couldn’t move Evelyn’s body off the
Evelyn Couch was a 43-year-old mother of stretcher. To get more help, the circulating nurse
two adolescent sons, scheduled for a robotic- hit the blue panic button; a blaring sound outside
assisted hysterectomy. At 5′10″ and 319 lbs in the corridor announced disaster. Staff came
(145 kg), she had a body mass index (BMI) of charging into OR 3M. It took six people to move
45.8. Evelyn had no medical history, but this Evelyn to the OR table. Reconnecting the moni-
might be attributed to the fact that the last time toring equipment revealed asystole. Manual
she had seen a physician was 13 years prior, after chest compressions were initiated and medica-
the birth of her youngest son. Evelyn only sought tions to restart her heart were administered. Bag
out her gynecologist after months of persistent mask ventilation was attempted and abandoned
vaginal bleeding. The dysfunctional uterine in the absence of the reassuring rise of her chest.
bleeding was associated with a large fibroid and Kelly unsuccessfully attempted intubation. The
the gynecologist recommended a hysterectomy. screeching monitoring alarms created an audible
Evelyn was found to be hypertensive (189/98) reminder of the dire circumstances and sharp-
and diabetic (Hgb A1C 12.4) during her preop- ened the team’s edgy apprehension. The resusci-
erative assessment. The newly assigned internist tation team arrived breathless from running,
delayed surgery for 6 weeks, while he brought 8 min after the call went out, as Kelly was pre-
both conditions under control. Evelyn’s only paring for a percutaneous airway insertion. The
other noteworthy medical issue was a history of responding anesthesiologist and Kelly worked
snoring. She had never been sent for a sleep together to insert the percutaneous tracheostomy
study. The screening anesthesiologist in the pre- tube, but the internal swelling and external adi-
admission testing center designated her at risk for pose tissue made it impossible. They called for a
obstructive sleep apnea and a difficult 3 of 4 intu- tracheostomy set and Otolaryngology stat. For
bation level. She was scheduled for the minimally the first time, luck worked in their favor as the
invasive surgical suite (MISS) where gyneco- on-call ENT resident was in an adjacent suite.
urological procedures were performed. The He arrived at the same time as the trach set and
MISS was connected to the main hospital through successfully established a surgical airway. It was
two blocks of internal corridors. Kelly success- 18 min since the resuscitation team had been
39 It’s My Fault: Understanding the Role of Personal Accountability… 667
summoned and within another 3 min Evelyn’s mance for a year to determine if the event repre-
heart began beating on its own. Evelyn was taken sented a pattern of substandard performance.
to the surgical intensive care unit late on that And with that pronouncement, his blameless 12
Friday afternoon to start brain cooling. years of dedicated service slid into oblivion. The
The entire event unfolded over 21 min but the RCA team approved the report. Catherine
retelling and responding to questions required informed them there was no need for more meet-
55 min of the RCA time. Catherine informed the ings. The report would be sent to the mandated
team that they had all the details they needed for committees and regulatory agencies. A newly
today. They would continue meeting to identify appointed Chief Medical Officer (CMO)
the root causes and develop plans for correction. reviewed the RCAs prior to presentation at the
At the next meeting, she would present the time Quality Committee. He rejected it as he said
line. Kelly knew what the root cause was and he human error was unacceptable. When human
didn’t need another meeting or an official time error is the root cause, the only thing to fix is the
line. He spoke up—“Before we go, I think you human. James Reason, the father of human error
need to know I recognize this event occurred as a theory, tells us “we can’t change the human con-
result of my judgment. I removed the tube and dition we can only change the conditions under
failed to immediately establish an airway. We lost which humans work” [11, p. 73]. The failure to
valuable time placing her on a stretcher and then identify the systems meant no organizational
back onto the OR table. Everyone pulled together learning. Catherine felt strongly that the RCA
as a team to support me after that bad decision. I team had determined there were no systems
don’t think we need another meeting to establish issues and reconvening them would be futile. The
that this was my fault. Time lines and meetings team had approved the report, it should be
won’t change what we all know to be true.” The accepted. The CMO instructed the Patient Safety
overcrowded, poorly ventilated meeting room Manager, Megan Carter, to meet with Dr. Stone
was now oppressively hot. The adrenalin fueled to ascertain the systems issues.
retelling of the event had been replaced with an Megan had been at the hospital for more than
overwhelming exhaustion. Kelly’s pronounce- two decades in varied administrative nursing
ment sucked what little oxygen was left, out of positions and 3 weeks as the Patient Safety
the room. Everyone averted their eyes as silence Manager. Through intensive study, she had
descended upon them; no one knew what to say. gained a respectable knowledge about patient
It filled the team with admiration for his courage safety. She had never led an RCA. Megan knew
and sadness for a wonderful professional. And that reading about RCAs didn’t necessarily make
then there was the fear. If this could happen to you ready to do one, leaving her anxious about
someone as good as Dr. Stone it could happen to how to proceed. She called Dr. Stone and he was
anyone. What would this mean for his career? unpleasantly surprised to hear a request for fur-
After all, they knew he spoke the truth. Catherine ther discussion. He had been notified that the
finally broke the silence saying “We appreciate report was complete. The facts were clearly laid
your honesty and insights Dr. Stone. We will out and he had admitted it was his fault. What
review all the information from today’s meeting else did they expect to find? Megan explained
and let the team know the next steps within a few that while they appreciated his acceptance of
days. We thank everyone for coming to the meet- responsibility, it would be useful to know if there
ing and for your cooperation. The honest, forth- was anything the hospital could do better to pre-
right explanations are critical to understanding vent future cases. Kelly reluctantly agreed to
what needs to be done to prevent this type of meet with her, largely as he felt he had no choice.
event in the future.” Megan knew that if you asked the question
Catherine wrote up the report identifying five times, you would arrive at the root cause in
human error as the root cause. Her corrective need of remediation [12]. That approach was a
action recommended monitoring Kelly’s perfor- huge failure. Every time Megan asked about why
668 E.A. Duthie
something happened, or why Kelly had per- have had to justify my decision about why a low-
formed a certain action, it led to a dead end. He risk patient was being left intubated.” Megan
would say that it was his judgment or he just responded “well you just described about half a
shrugged. And Megan didn’t disagree with him. dozen system issues that need to be fixed so that no
Even as she was asking him why he extubated the one else needs to face the same hard decision you
patient she was thinking in her head “because I had to make.” Kelly looked startled. Before he could
thought she was ready to be extubated.” And in respond, Megan asked a clarifying question. “You
fact that was the answer she got. It all seemed so mentioned low-risk patients are treated in
lame. She didn’t even bother to ask the next “why MISS. Was Evelyn low risk?” Kelly said “actually
did you think she was ready to be extubated?” as no, she was an ASA 3. Come to think of it she didn’t
it seemed insulting and challenging to his judg- meet our criteria for a MISS case. There must have
ment. Maybe the risk manager was right; some- been a scheduling error. She should have been done
times it’s just human error. Or maybe Megan just in the main OR.” Megan confirmed that this was
didn’t know how to ask “why” questions cor- another systems issue for investigation. The RCA
rectly. The entire process took less than 5 min team had agreed the event was attributable to per-
and Megan had learned nothing new. The atmo- sonal accountability. The follow-up interview sug-
sphere was tense and awkward and Megan gested organizational systems in need of
wanted to bring it to a close. She decided to ask investigation. A workgroup of clinicians not
one final question and call it a day. involved in the event was convened to better under-
“What would have happened if you had left her stand why the adverse outcome occurred.
intubated?” Kelly looked up in surprise and gave a
rapid-fire response. “Are you kidding me? We can’t
leave patients intubated in the MISS. It would have The Second Story: Why It Happened
taken the OR out of service as the nurses in the
MISS post-anesthesia care unit (PACU) aren’t What happened is called the first story and why it
trained to care for ventilated patients. Every minute happened is the second story [13, 14]. The time
the OR is delayed is analyzed and charged to some- line (Fig. 39.1) summarizes what happened based
one’s budget. If we are obtaining a patient consent on the group RCA meeting (many of the times
while the OR is ready, that would be charged as lost assigned to the event are based on participant
time to the Anesthesiology budget, and I would be guesses about how long between events and may
personally assessed. If we need to send a patient to not be technically accurate).
the main PACU we have to beg the nursing manager The second meeting to ascertain why the event
to help us. I would have had to recover the patient in occurred never happened as Kelly’s self-
the OR until they found us space. In the old days assignment of blame was accepted as the root
when we took a patient to the main PACU, the wait- cause. Table 39.1 lists the systems issues identi-
ing times were outrageous. There are no respiratory fied by the RCA team in the group meeting as
therapists covering the MISS as our patients are all compared to Kelly’s interview.
low-risk and shouldn’t need coverage. If I have to The change to the operative location for high-
transport an intubated patient to the main PACU, I risk patients uniquely contributed to the event.
need to talk to the respiratory therapy supervisor for The hospital had one robot for urology and one
a special authorization and then wait for a therapist for gynecology. The MISS performed robotic
to be deployed. This all came down on a Friday procedures for low-risk patients and the main OR
afternoon. If I had left her intubated we could have performed the higher-risk patients (i.e., ASA
been in that OR well beyond the scheduled OR clo- class 3–4 patients). The robots were moved
sure time of 1700. Now in addition to the lost OR between MISS and the main OR to accommodate
time there would have been nursing overtime. Do the cases. Transporting this expensive equipment
you know how popular that would have made me two blocks on and off elevators resulted in dam-
with the nursing staff on a Friday afternoon? There age with costly repairs and equipment downtime.
would have been hell to pay. Afterwards, I would Cases were reassigned to a non-robotic approach
Fig. 39.1 RCA time line of event
as the equipment malfunctioned or was found committee made recommendations for the clini-
damaged at the start of the case. The surgeons cians’ consideration. In reality, the power bro-
submitted a request to the Resource Analysis kers who sat on the committee viewed challenges
Committee (RAC) for more robots to eliminate to their decisions as a lack of commitment to the
the need for cross campus relocation. The com- organization’s fiscal viability. The word on the
mittee was comprised of financial and adminis- street was to comply rather than engage in a
trative staff that reviewed the fiscal implications futile argument. The two surgical chairs from
for new programs, expensive equipment pur- urology and gynecology notified the affected
chases, processes that met outlier criteria for surgeons that going forward all robotic urology
higher-than-expected costs and any other high- and gynecology cases would be performed in the
cost problems referred for review. There were no MISS. The anesthesiologists weren’t included in
clinicians on the committee as the focus was this communication. The anesthesiologist who
financial rather than clinical. The resource com- screened Evelyn in preadmission testing indi-
mittee referred the request for the purchase of the cated on the form that the procedure was to be
two additional robots to the capital strategic plan- performed in the main OR, unaware that the OR
ning committee which meets annually to align assignment would be ignored.
the purchase of expensive technology with pro-
grammatic mission. The strategic capital com-
mittee wouldn’t be considering the purchase for The Role of Mental Models
several months and if approved, it would be sev-
eral more months before it arrived. It was 2 weeks from decision to impact. The
In the interim, the resource committee recom- screening anesthesiologist had refined the MISS
mended that the equipment be permanently triage criteria to accurately identify low-risk
located in the MISS where all cases would be patients with exquisite precision. In post-event
performed. This would reduce the costs associ- reviews no one could recall the last time a
ated with repairs, lost equipment time, and patient was sent to the main PACU for extended
rescheduled procedures. In theory, the resource ventilation or other problems. Kelly’s knowl-
670 E.A. Duthie
Table 39.1 Comparison of factors from RCA and the patients had surgery in the MISS, production
clinician interview
pressures with punitive enforcement, and an
Contributing factors Factors identified from organizational culture that valued financial pri-
identified during RCA clinician interview
orities. His mental model was deeply entrenched
Inadequate space in the Financial decision changes
in his subconscious and gave rise to a pre-com-
ORs with robots operative location for
high-risk patients piled response [20].
Patient is moved off OR Anesthesiologists aren’t A pre-compiled response has been described
table in acute distress informed of the change for as “recognition-primed decision-making”
high-risk patients acquired through personal experience [21]. In
Inadequate resources Forms for assignment of other words, our prior interactions build patterned
for moving obese patient’s operative location
patients aren’t changed
responses in similar situations. Pre- compiled
No established process Intubated patients in MISS
responses are quick, intuitive, carry a low cogni-
for patients that can’t be PACU are recovered in OR tive burden and are highly effective in familiar
ventilated or intubated situations [21]. Evelyn was successfully intubated
Distance for hospital Lack of respiratory therapy and her procedure was uneventful. Kelly reflex-
resuscitation team to support for MISS patients ively extubated her just as he had in hundreds of
reach the MISS is
excessively long patients before. His recognition-primed decision-
Cricoid insertion fails Lack of access to main making was for low-risk patients seen every day
when excessive neck PACU level of care in MISS, unaware that Evelyn didn’t fit this pic-
adipose tissue and ture. When Evelyn struggled to sit up Kelly’s
internal swelling are response was to assist her. Because Evelyn’s dis-
present
tress was so immediate, he had no time to process
Need to justify clinical
decisions which impact a change to his mental model. Once the new,
financial outcomes unexpected reality of the situation registered how-
Charges assigned to ever, critical thinking kicked in. He deployed the
individuals for lost resuscitation team and summoned help. Given the
productivity
limitations of the MISS environment, his manage-
Production pressures
ment of Evelyn’s distress was appropriate. To
achieve a different outcome, Evelyn should have
edge that only low-risk patients had surgery in remained intubated until her airway swelling
MISS supported his mental model in care deliv- resolved, or clinicians skilled in surgical airway
ery to Evelyn. Mental models are formed by the procedures should have been present during her
individuals’ professional knowledge, the experi- extubation. This would have required an aware-
ence, and the systems in which they work (i.e., ness of Evelyn’s risk status and collaborative pre-
group dynamics, organizational rules, manage- planning prior to her surgery. This form of system
rial implementation of work practices, and insti- redesign is intended to create a new mental model.
tutional culture) [2, 15–19]. They constitute a Successful system redesign requires detecting the
person’s beliefs about how to respond in a given contributory faulty systems and thinking about
situation, converting organizational policies and how the new system will confer a different metal
procedures into a functional reality. Mental model on the providers.
models are incomplete, unstable, dynamic, and
evolving and contain gaps as clinicians cope
with the messy, uncertain complexities of clini- Discovering Flawed Systems
cal practice [2, 15–19]. Components of Kelly’s
mental model included the organization’s Systems are the foundations of our mental mod-
emphasis on efficient throughput, the lack of els dictating how clinicians respond in a given
resources to manage patients on a ventilator, the situation [2, 15–19, 21]. Organizational learning
screening process that ensured only low-risk about how to prevent future harm emerges from
the discovery of how individuals transform sys- evance [2, 11, 14, 23, 26, 34, 35]. When deci-
tems “from work as imagined to work as actually sions are lost to the subconscious, clinicians
performed” (i.e., their mental models) [21]. can’t tell you why they performed an action [29–
Uncovering how clinicians navigate the systems 34, 36], rendering the “five why questions”
that the organization designed requires a nonjudg- mostly ineffective. A better approach is to recon-
mental approach [2, 13, 14, 22, 23]. While organi- struct the real world with its competing demands
zations articulate that they are seeking systems and and barriers that conspired to derail success [13,
avoid blaming individuals, frequently they miss 14, 23]. Seeking to determine what went wrong
the mark sending subtle signals of liability and by challenging clinicians as to why they didn’t
implied censure under the guise of accountability. follow the correct course of action transforms
An unintended consequence of accountability is to the investigation into a blaming event and clini-
drive blame underground making it more difficult cians recoil in defense [13, 14, 23]. Information
to recognize and avoid. A physician who served on sharing quickly shuts down which may shape
the serious adverse event reporting committee at future behaviors for clinicians, especially trainees
his hospital commented in 2015 that “we’ve really [31]. Instead patient safety practitioners should
made progress with our RCAs. We now ask why consider guiding the frontline clinicians through a
five times until we find who did it.” When serious detailed story telling while avoiding drawing con-
harm has transpired, self-blame and fear are inevi- clusions. These investigators tirelessly pursue, in
table [2–5]. The investigator’s approach to clini- exhaustive detail, the circumstances surrounding
cians will determine if these feelings are intensified the incident in order to understand why the clini-
or abated. Using non-blaming language and clari- cians acted as they did [13, 14, 23].
fying the goal are intended to reduce the anxiety of The real challenge is to reconstruct the reality
the interview process [24]. Designating it as an of the world at the time of the event without intro-
event debrief, rather than incident investigation, ducing the new post-event reality [32]. This form
may be less threatening [25]. Articulating that the of incident investigation seeks the perspective of
investigation is seeking flawed systems transfers the clinicians by looking forward through their
the focus from the individual to the organization. eyes, reconstructing the assumptions and thought
One researcher has suggested that renaming the processes before disaster struck, instead of look-
individuals investigating adverse events as organi- ing backward from the error [13, 14, 23].
zational learning specialists may reduce fear and The flawed systems reside in the mental mod-
improve information sharing [26]. els that made so much sense before life fell apart.
Uncovering system flaws starts with under- Seeking one absolute version of the event forces
standing the perceptions of the participants and a decision about who is lying and who is telling
why they responded as they did. Reliance on the the truth when in reality this determination is not
clinicians’ acknowledgment of responsibility or only rarely possible, but creates more fear and
explanation of the event is an error-prone silence. Mental models are imperfect and are
approach as the involved practitioners frequently designed to be more functional than technically
don’t understand or misremember what hap- accurate [15, 18, 19, 21]. In addition, they may
pened [13, 14, 27–33]. Research has shown that differ between individuals, creating inconsistent
40 % of all decisions are habits that occur with- viewpoints of what transpired. Discrepant stories
out conscious input [30]. Workers constantly can be a rich source of organizational learning as
make decisions, frequently unaware that they are they frequently represent goal conflicts experi-
responding to the systems in which they them- enced during the unfolding event. Varied
selves are embedded [21, 23, 25, 30–36]. The accounts, like a Rashomon-like investigation,
context of the surrounding events matter, but the should be viewed as clues that can advance
involved individual may not recognize their rel- understanding and learning [13, 14, 23].
672 E.A. Duthie
The Story Continues manage patients who can’t be intubated and can’t
be ventilated would move to the forefront of care.
Evelyn never regained cognitive function. She Evelyn’s case is yet another example of clinical
was weaned off the ventilator and able to breathe practice changing faster than the science to sup-
on her own. Tube feedings sustained her life. port it. And yet, the clinicians on the front lines
After 3 months in an acute care setting, she was are expected to perform within the highest stan-
sent to a traumatic brain injury unit to enhance dards that will ensure a positive outcome. Only
cognitive recovery. After 9 months with no appre- years later was the significance of Evelyn’s case
ciable change, she was sent to a nursing home. recognized and practice guidelines developed.
The hospital negotiated a multimillion dollar
settlement. Evelyn’s heartbroken family remained
devoted to her and at the time of settlement con- Accountability
tinued to harbor tremendous anger. The event
triggered the purchase of two new robots that Does this case study illustrate that if the systems
arrived within 3 months. High-risk patients were are at fault that individual accountability doesn’t
scheduled only in the main OR and the robots matter? That depends. Accountability is about
remained in MISS. There was a hiatus of high- how rule breaking is perceived and managed. To
risk robotic cases while awaiting the arrival of the answer this question requires an understanding of
new equipment. A new senior leadership team, the beliefs and values surrounding rule breaking.
knowledgeable about patient safety concepts, In the wake of an adverse event, it is common to
arrived just a few months prior to Evelyn’s sur- identify a missed step in the process or a broken
gery. They began changing the organizational rule as the cause. Invoking sanctions for omis-
culture. The resource allocation committee was sions or rule breaking is seen as holding individu-
disbanded and a new patient safety finance com- als accountable. Rule enforcement effectively
mittee was convened. It consisted of financial, communicates high standards when an individual
clinical, and administrative senior leaders as well purposely disregards a good rule [9, 29, 37].
as board members from the quality and finance When the rule breaking is unintentional, the same
committees. Clinicians were invited to make pre- process is a blaming behavior [29, 37]. If only
sentations and financial decisions became patient Kelly had been more careful in following the
centered and collaborative. The monitoring of basic rules of airway management, Evelyn might
clinicians for wasted OR time was suspended not have sustained brain damage. Holding him
pending reassessment. It was reinstated after 6 accountable for following a rule he never intended
months with a focus on organizational systems to break is punishing human error.
(i.e., barriers clinicians encountered that inter- A strongly held belief supporting sanctions is
fered with meeting productivity targets). the myth of personal control [27–29]. This view
Monitoring to identify outlier performers sees the individual’s actions as separate from and
resumed but financial charges to individuals and independent of the surrounding environment. It is
departments did not. Kelly Stone continued his consistent with the traditional view of the practi-
distinguished career in anesthesiology. tioner as solely responsible for the care and out-
Clinical practice lagged behind the other orga- comes of the patient [2, 38–42]. Responsibility
nizational changes. Evelyn’s weight was the har- for decision-making is seen as a personal choice
binger of an emerging era in healthcare that went [2, 23, 25–28], and there is a lack of appreciation
unappreciated. The organization attributed her that practitioners are responding to the context in
extreme obesity as a “one off” and processes to which they work [2, 11, 13, 14, 16, 19, 22, 27, 28,
manage it weren’t developed. It would be another 42]. The myth of personal control is a form of
5 years before the anesthesiology’s guidelines for denial that deflects the responsibility away from
obstructive sleep apnea would be published. It the organization, thereby limiting learning [2, 11,
would be closer to a decade before the need to 13, 14, 27, 28]. If the RCA had ended with the
monitoring of Kelly’s performance, many key rule is that the attending must remain in the OR
systems for this adverse event would have been until the count has been reconciled. Since the sur-
missed including the inadequate number of geons left the OR in violation of the rule, should
robots, the role of the resource allocation com- they be punished? The answer requires under-
mittee in decision-making about clinical care, standing the context of their decision. In one
and the emphasis on financial priorities. These case, the attending left the OR to assist in rescu-
flawed systems might never have been identified ing a patient with a vascular injury during robotic
and corrected. When the story begins and ends surgery. His prompt response saved the other
with the person, there is nothing to be learned or patient’s life. In the second case, the surgeon left
improved. for the airport to meet his family for vacation.
But doesn’t this support that it is always the When the procedure ran later than anticipated, he
system and never the person? The answer is no in failed to arrange coverage with a colleague. In a
a just culture. A just culture is an open and fair just culture the first surgeon shouldn’t be sanc-
approach to human error that supports learning tioned, but the second surgeon should be. The
after an adverse event [27–29, 37]. Sanctions are first surgeon’s rule breaking was intended to
rarely invoked in healthcare as workers almost improve care while the second surgeon’s was not.
never break rules with malevolent intent. In both instances changing the system to ensure
Intentional rule breaking is commonplace to an attending radiologist reviews the film when
accommodate variation in care delivery [43]. the attending surgeon is unavailable would ensure
For example, dual identifiers using the patient timely detection of the retained sponge. Even
identification bracelet are mandated at the time of when rule breaking occurs, systems should be
medication administration. Anesthesiologists assessed for improvement opportunities.
during operative procedures, and resuscitation
teams during a cardiac arrest, omit patient identi-
fication as the risk of misidentification is elimi- Root Cause Analysis
nated when caring for one patient. This intentional
rule breaking is intended to save time by elimi- Is the RCA process capable of transforming the
nating a non-value-added activity. Clinicians that tragedy of Evelyn’s harm into system redesign
save time by omitting the intravenous line port that would save the next patient? Understanding
disinfection are exposing patients to a possible what the research has to say about the strengths
blood stream infection. In this situation, the and weakness of the RCA process informs the
intentional rule breaking isn’t intended to answer. The RCA process begins with the notifi-
improve patient care and sanctions will commu- cation about the event and the interviews of par-
nicate organizational value for this activity. The ticipants [12, 44, 45]. It has been noted that “You
worker, who forgets to sanitize his hands and only have 24 hours to uncover the naked truth.
does so in response to a colleague’s prompt, After that, it will be all dressed up and ready for
shouldn’t be punished. Clinicians, who refuse to the party that is about to begin” [46, p. 3]. Stories
perform hand hygiene in response to a prompt, evolve with repetitive telling [23].
should be sanctioned. Intentionality matters and As the horror of the event unravels within the
is integral to determining when punishment is caregivers’ minds, their perceptions are altered
appropriate. In a just culture, human error (i.e., and reshaped [47]. Interviewing staff as close to
unintentional rule breaking) isn’t punished but the event as possible, is crucial to the discovery
egregious rule breaking is. of the mental models in play at that time [23, 45].
Two separate surgeons left the operating room In addition, TCIMC often did group interviews
when the sponge count was wrong and the film such as the one where Kelly accepted responsi-
was still pending. The resident misread the X-ray, bility for the adverse outcome. The goal was to
the retained sponge went undetected and both understand the shared mental models during the
patients had a second procedure to remove it. The event. After the group interview, the involved
674 E.A. Duthie
clinicians were invited to participate in the RCA Once the RCA team is satisfied they under-
to identity the systems issues and develop correc- stand what happened, their next mission is to
tive action plans. Attendance was optional and a find problems to fix. How RCA teams success-
clinician’s decision to participate or not was fully achieve this mission is drawn from this
respected. The group interview was very helpful author’s experience in close to two decades of
in clarifying issues and completing gaps in the working with RCAs across a broad range of
individual interviews. There were no records of organizations. RCA teams seek out problems by
attendance at the RCAs so it isn’t possible to searching the time lines for failure points. In
know how often the clinicians accepted the invi- Evelyn’s case the clinicians determined placing
tation to participate. Those who did participate her on a stretcher in response to her respiratory
said that they attended in the hopes that some- distress was a fixable problem. The corrective
thing good could come out of the event so that it action plan was to develop a protocol with an
would never happen again. Anecdotally, these algorithm to guide the anesthesiologist’s
clinicians reported that action plans were very response. The protocol is a short-term solution
important to them. that allowed TCIMC to submit an achievable
The current literature recommends excluding plan within the regulatory deadline of 30–45
clinicians who were involved in the adverse out- days. Quickly developing a practical solution
come from participating in the RCA to avoid communicates to the public and regulators that
introducing those clinicians’ biases into the pro- organizations are concerned and take the event
cess [45, 48]. Evidence supporting improved out- seriously [26]. It also creates a sense of closure
comes from this recommendation and discussion for clinicians and that normalcy has been
about unintended consequences could not be restored. The downside of an aggressive dead-
located. There are several adverse consequences line is that it only allows time to remediate sim-
to this recommendation, including that the shared ple problems rather than the broader systems
mental models of the team and the accompanying changes that take months to accomplish and that
systems may not be fully understood without the underlie the mental models.
input of the individuals making the decisions that RCA teams are usually comprised of frontline
led to the adverse event. More importantly, decid- clinicians without training in systems theory [48,
ing to proceed with RCA without active and con- 50–52]. When developing solutions they most
tinuous input and participation from involved typically employ strategies with which they have
clinicians can lead to further fear, obstruction and familiarity, such as writing new procedures or
lack of trust [49]. protocols [26] instead of trying to understand the
The opportunity to clarify the issues during the events that transpired using concepts from human
RCA is lost. Ensuring that the depth and breadth factors engineering [53]. The solutions frequently
of the interviews are adequate becomes even more address what went wrong (e.g., moving Evelyn
crucial to ensure that the RCA teams are equipped off the OR table) instead of why the adverse
with complete and accurate information. Kelly event occurred (i.e., Kelly’s mental model).
didn’t know that the location for the high-risk Consequently they fail to detect that their pro-
patients had been changed but the surgeon did. If posed solution is ineffective. Kelly’s decision to
the two are sharing information during a group move Evelyn into a sitting position wasn’t driven
interview, the discrepant knowledge might be dis- by a lack of knowledge about how to clinically
covered in a timely manner. Without this vital manage her care. His pre-compiled response was
information, the ability to reconstruct the mental to manage Evelyn as he did every other MISS
models is lost or misunderstood, and the accom- patient. A second time line (see Fig. 39.2), from
panying flawed systems may not be recognized. Kelly’s interview after the group meeting, makes
RCA teams, which are unaware of mental models it apparent that effective solutions would need to
and the connection to faulty systems, will focus correct factors beyond what happened in MISS
instead on what happened. that day.
Fig. 39.2 Interview time line of events
Research has shown that RCA teams pursue in play that day. They comprise the systems that
fixes within their reach [26, 54, 55]. The produc- collided in the OR resulting in patient harm.
tivity issues were politically charged and outside Flawed systems will not be found in time lines.
of their scope. The CMO presented the informa- To improve detection of faulty systems, experts
tion from Kelly’s interview to the newly appointed recommend using a causal tree to visually dis-
senior leadership team. They changed the finan- play antecedent events (i.e., the why answers)
cial decision-making process and eliminated [57]. There are many different versions of causal
punitive productivity targets. Their decisions trees and all involve time-consuming analysis. To
would have far-reaching positive implications for meet mandated deadlines, RCA teams avoid the
patient safety across the organization but were in-depth analysis required to understand why an
too late to help Evelyn. But realistically would an adverse outcome occurred. Instead they focus on
RCA team be capable of such system redesign? responding to what went wrong which represents
The realities of regulatory mandates and the pres- a more achievable workload burden.
sure to reassure the public create the mental mod- Writing a protocol for the management of
els where RCA teams avoid system-level fixes patients who can’t be intubated is designed to
outside of their reach [26, 45]. But durable, manage the complication (i.e., reactive).
meaningful improvements reside in system-level Preventing the complication (i.e., proactive)
change [2, 11, 13, 14, 27, 28, 42, 56]. This means involves creating a shared mental model [58] for
RCA teams need more information than what is the entire team at the start of Evelyn’s surgery. A
available from the time line depicting the event. handoff from the screening anesthesiologist
Table 39.2 lists the omitted contributing factors about her risk for obstructive sleep apnea and dif-
from both of the time lines. ficult intubation could generate a revised and
The contributory factors in Tables 39.1 and improved mental model and include a conversa-
39.2 are the building blocks of the mental models tion about equipment selection to maximize a
676 E.A. Duthie
Table 39.2 Factors omitted in time lines pected by creating agility in their reasoning [2,
Anesthesiologists aren’t notified of a change in the 13, 14, 16–19, 21, 22, 27, 28, 42, 58]. TCIMC
operative location for high-risk patients created stronger systems for financial decision-
Forms for assignment of patient’s operative location making but not for clinical processes. The RCA
aren’t changed
team did the best they could, given the state of the
Intubated patients in MISS PACU are recovered in OR
patient safety science at the time. Looking back
Lack of respiratory therapy support for MISS patients
we can see a better way and this has implications
Lack of access to main PACU level of care
for managing RCAs.
Focus on financial concerns over clinical issues
The retro-scope provides a clear vision of how
Lack of clinical input into financial decision-making
events could have been better managed. When
Production pressures
the retro-scope is applied to a single adverse
Charges assigned to individuals for lost productivity
event, it may introduce hindsight bias which
Need to justify clinical decisions which impact
financial outcomes superimposes knowledge about the outcome to
assign blame and identify how clinicians got it
wrong. When the retro-scope is applied to multi-
successful intubation on the first attempt. If mul- ple RCAs for aggregate analysis, it can provide a
tiple attempts at intubation occur, proactively rich source of information about common organi-
planning for a prolonged intubation, finding a zational themes [25]. Patient safety experts are
monitored ICU-like bed, or a surgical airway at questioning the wisdom of creating system rede-
the time of extubation would be considered [59]. sign based on a single event [26]. Instead aggre-
Had Evelyn’s procedure been performed in the gate analysis is being advocated to identify
main OR, the decision to leave her intubated flawed processes involved in multiple RCAs [54,
would have been easier as the barriers present in 61]. Effective system redesign remediates the
the MISS didn’t exist. But without the preplan- faulty systems creating the potential for a new
ning conversations, the mental models remain ending in Evelyn’s story.
unchanged and the potential of the same event
occurring in the main OR is very high. Unless the
unexpected is explicated, mental models won’t Writing a New Story
be reset [58]. Changing mental models to build
resilience for coping with the unexpected has The lessons learned from any adverse event are
begun to emerge in healthcare. useful only if they allow a new narrative to be
Simulation for hard-to-intubate patients is an written. Creating a new story begins with under-
example of a program intended to build clinical standing the behaviors during the adverse events
expertise for rare and unpredictable events [60]. and the two factors shaping them. The first factor
When clinicians participate in drills for rarely consists of core values and beliefs. The second is
occurring events where reaction time is critical, the clinician’s response to the systems in which
they are building pre-compiled responses that they work (i.e., the mental models). Mental mod-
will maximize performance under difficult cir- els have been explored in this chapter but to fully
cumstances. Well-intentioned RCA teams seek to understand how the organization responded to
control the unexpected with more rigid and pre- the event requires an examination of the beliefs
scriptive procedures. They erroneously believe and values.
that if they spell out how to respond in a given Kelly’s acceptance of responsibility for his
situation, that clinicians won’t err. A well-written decision was based upon deeply held profes-
procedure supports practice in routine, predict- sional values. If his excellent work ethos was
able situations. But when the unpredictable attributable to him, when things went wrong, he
occurs that isn’t covered by the procedure, trou- needed to own that as well. His acknowledge-
ble arrives. The goal should be to build resilience ment of responsibility during the group RCA
that allows clinicians to respond to the unex- meeting was courageous, ethical, completely
understandable, and yet totally misguided. ultimately channeled through relationships

between human beings (such as in medicine), or
Drawing on his education and professional
through direct contact of some people with risky
experience, he believed he was solely responsi- technology. At this sharp end, there is almost
ble for the outcome. Megan, the patient safety always a discretionary space into which no system
manager, drew on his professional altruism to improvement can completely reach. Rather than
individuals versus the systems, we should begin to
reset his mental model. Introducing the idea he
understand the relationship and roles of individuals
could prevent his colleagues from traveling the in systems. [29, pp. 131–132].
same path he had, she persuaded Kelly that
making changes beyond his own practice would
be valuable. But the other RCA team members
shared his viewpoint and changing their belief Closing Thoughts After 20 Years
systems would need to occur as well.
Catherine Parker, the risk manager, admired Finding the balance between systems and indi-
Kelly’s courage and supported his perspective as vidual performance continues to be an ongoing
it was consistent with her own personal values. challenge 20 years after the Joint Commission’s
She frequently spoke about how the systems sentinel event guidelines. The concern that indi-
approach was protecting staff from punishment vidual accountability may get lost is valid. I have
and would ultimately lead to careless practitio- taught new nurses systems theory with the goal
ners and lower standards. As human error of emphasizing the importance of event reporting
involves rule breaking [11, 27], she passionately for the identification of flawed systems for reme-
believed that the answer to errors was for workers diation to improve safety. When interviewing a
to follow the rules. She viewed her perspective as new nurse about a medication error, she reported
holding individuals accountable and not a blam- that it was a result of a bad system design.
ing approach. Catherine’s blame-based mental I remember thinking “I’ve died and gone to
model never changed and had implications for heaven, at last, here is someone who gets the
her and the organization. She guided RCA teams importance of systems issues.” When I asked
to add more rules, educate clinicians to follow what the flawed systems were in need of fixing,
the existing rules or enforce rules (see Table 39.3). she responded, “I have no idea. I went to a class
Yet Her system fixes were a subtle form of on medication errors and they told me that errors
blame that went unrecognized. When Catherine’s aren’t my fault, it’s from bad systems.” And at
fixes are compared against system redesign that moment, I went from heaven to the seventh
(Table 39.3), it becomes evident that she sought circle of hell. The lack of accountability and
to enlist staff in doing a better job instead of seek- insight was appalling. In the course of the inves-
ing how systems could support clinical practice. tigation, it became clear that she was a scattered,
The hallmark of a well-designed system is that it disorganized practitioner frequently over-
makes life faster, easier, and safer for the staff whelmed by her patient care assignment.
[27]. Catherine’s mental model of focusing on Although the interview with this young nurse did
human performance didn’t include system reveal the flawed systems, she wrongly assumed
improvements. She believed finding fault with she had no responsibility whatsoever. The
the system meant individual accountability didn’t systems were redesigned and the nurse manager
matter. Her values reflect the fears expressed in and educator intervened with the nurse to improve
the literature [7–9] and underscore why the sys- her performance. Both outstanding and incompe-
tems and individuals must be considered as inte- tent clinicians may be involved in adverse events
grally connected. Sidney Dekker eloquently and their beliefs matter.
explains the concept in Chap. 2 and below: In addition the beliefs and values of the senior
Systems are not enough. Of course we should look leaders are important. The resource allocation
at the system in which people work and improve it committee believed that ensuring fiscal viability
to the best of our ability. But safety critical work is for the organization was the most important goal.
678 E.A. Duthie
Table 39.3 Approaches to system redesign

Comparison of rule-based and system redesign fixes
Event Analysis of error Rule-based system fixes Redesigned systems
RN administers a tenfold Cognitive flip Implement an independent Unit dose dispense the
overdose of oral methadone confusing mg with mL dose calculation by a volume in an oral syringe
when she draws up 20 mL (dose was 20 mg) second clinician (add more eliminating the need to
from multidose bottle instead steps to intercept the error) calculate and draw up
of 2 mL (10 mg/mL) medication (eliminates the
cognitive flip)
Anesthesiologist delays Mental model expects Write a procedure to Proactively identify at risk
intubating a patient in acute low-risk patient who ensure a prompt response patients & engage the team
distress will not need (add more rules to guide in developing a plan
re-intubation practice) during a pre-procedure
briefing (reset the mental
model)
Patient sustains fatal cardiac The 24 h fluid balance Educate RNs about the Change the 24 h time to
arrest from fluid overload sheets are to be importance of fluid balance midnight providing a 5 h
associated with 10 L (+) fluid completed in the final sheets and monitor window to complete the
balance over 3 days. RNs are hour of the night RN’s compliance with totals before rounds
not completing the totals for shift when there isn’t completion (rule (redesigns workflow to a
fluid balance sheets and adequate time. The enforcement) more convenient time)
physicians aren’t checking it timing is after Computerize the fluid
morning rounds so balance sheet w an
physicians don’t see auto-add feature (automate
the totals the task)
Physicians inserting CVLs The items for the line Require physicians to use a Provide a kit that contains
forget some items insertion are stored in checklist for selecting the all of the items except for
necessitating the RN leave the different locations on supplies prior to the the size-specific items
bedside to retrieve missing every nursing unit procedure (add an (e.g., sterile gloves and
items during the procedure requiring physicians to additional step to reduce catheter) and store the
rely on memory for reliance on memory) size-specific items
the required items and adjacent to the kits
the location (eliminates need for recall
and a checklist)
The razor-thin margins, clinically important pro- challenged went unspoken. The new leadership
grams that were underfunded, and reduced reim- team recognized the futility of trying to change
bursements shaped their mental models. Removed the process with the current members. They dis-
from clinical care, they didn’t understand the banded the committee in favor of a collaborative
impact of their decisions and didn’t hear about structure to better align senior leaders with front-
adverse events. This was the first time a financial line clinicians. Academic medical centers that
decision had been connected directly to an place patient care first in the tripod mission of
adverse outcome, but in informal conversations education, research, and patient care have better
with clinicians, many will draw a direct line safety profiles than hospitals that value education
between adverse events and financial decisions to or research above patient care [61]. TCIMC used
cut clinical services. The resource committee’s Evelyn’s story to place patient safety at the top of
response was to hold the clinicians accountable. their agenda.
They correctly asserted that they weren’t quali- The path from a flawed financial decision to a
fied to make clinical judgments and the clinicians delayed intubation is arduous, exhausting, and
needed to inform them if the recommendations politically charged. To achieve a different out-
were inadvisable. Yet they clearly communicated come the resource committee members needed to
they were right and the clinicians were wrong. change their beliefs about decision-making. The
The message that they weren’t receptive to being new leadership team had suffered the conse-
quences of poor fiscal decisions, motivating them nizing their mental models, the systems driving
to restructure the decision-making process. them, and the science behind system redesign.
System redesign requires thoughtful consider- Clinicians, frontline workers, patient safety prac-
ation of the political ramifications. Presenting titioners, and organizational power brokers need
information that reflects negatively on the organi- to form a shared mental model of how to manage
zation requires extraordinary diplomacy. Chances rule breaking and how to transform the tragedy of
of success are enhanced when the patient safety patient harm into durable patient safety
practitioner sits at the table with senior leaders advancements. To develop a shared mental model
and has a profound knowledge of the organiza- means learning, not just about the adverse event
tional culture. Challenging the culture when you and how clinicians navigate faulty systems, but
are an accepted and valued member of the leader- what it communicates about organizational val-
ship team improves the chances of success. ues. Because competing goals are both valued,
Patient safety practitioners are educated about balancing them is difficult. Production pressures
human error theory, systems engineering, root are tremendous in operative settings as ineffi-
cause analysis, and failure modes and effects ciency represents waste in the system that can
analysis, but courses in diplomacy and organiza- impact the bottom line. Lost OR time is easy to
tional politics are lacking. An organizational measure and assign to individuals who can make
mentor is invaluable for patient safety practitio- improvements. Many believe that the impact of
ners navigating the dangerous, uncertain political productivity pressures on patient safety is signifi-
waters. If organizational politics had supported cant and yet hard to definitively measure.
the RAC decision-making model, the risk of Competing priorities may contribute to adverse
recurrent patient harm would have persisted, outcomes [2, 11, 27]. They are all too common in
illustrating how values may negatively impact the healthcare and present a serious conundrum for
patient safety mission. So how do we effectively patient safety practitioners trying to improve
advance patient safety? patient safety.
Learning from adverse events can transform In closing, if we are to rewrite Evelyn’s and
knowledge into meaningful safety advancements Kelly’s life stories, we would need to rewrite the
but is extraordinarily difficult. Kelly viewed the approach to adverse events. Instead of seeking
adverse event as a result of his clinical judgment. problems to be fixed, we should seek to under-
He was an expert clinician but lacked familiarity stand why life unfolded as it did. Understanding
with mental models and their influence on why Kelly couldn’t leave Evelyn intubated gen-
decision-making. The risk manager attributed the erated a wealth of knowledge. Helping her onto a
event to human error despite limited knowledge stretcher makes sense. The faulty systems reside
about human error theory. The frontline staff in the mental models and sense-making capabili-
implemented a system fix despite a lack of under- ties of the clinicians. Skilled and humble investi-
standing about systems theory. The patient safety gators are required who have the patience to elicit
manager had a broad knowledge of human error them during interviews. Simulating interviews is
and systems theory but was politically inept. The one approach for ensuring competent investiga-
original leadership team believed in patient safety tors. From the mental models, the faulty systems
but had limited knowledge about how to make it emerge. Individuals skilled in systems or human
happen. The resource allocation committee truly factors engineering training are critical in effec-
believed they were saving the organization from tively remediating these systems to truly prevent
financial ruin and that their decisions didn’t affect the patient harm from recurring. Leaders across
clinical outcomes. These knowledge deficits may all levels need to understand the organizational
explain the glacial progress in patient safety. patient safety values, recognize the difference
Advancing patient safety requires skilled indi- between blame and accountability, and have a
viduals with knowledge about systems theory rudimentary understanding of systems theory.
that can guide the frontline clinicians in recog- Seeking to understand their own values and what
680 E.A. Duthie
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Capturing, Reporting,
and Learning from Adverse Events 40
Juan A. Sanchez and Paul Barach
“… The value of history lies in the fact that we learn by it from the mistakes of others, as
opposed to learning from our own which is a slow process.”
—W. Stanley Sykes, 1894–1961
nities to understand how the process failed and

Introduction how to improve the delivery of care.
The increasing emphasis on value, outcomes,
Efforts to reduce rates of errors and adverse and quality should motivate organizations to
events have not yielded the results desired in part focus attention on preventable events as a strat-
as a result of the complex nature of healthcare [1, egy with the highest priority. In one study, the
2]. Unsafe patient care, however, continues to be majority of consumers surveyed indicated an
widespread and recurrence of the same errors and expectation that all healthcare workers should
harm are common. Each preventable “defect” in report all errors [4]. However, while incident
care, whether causing harm or not, is an opportu- reporting systems are being increasingly used,
nity to learn and redesign processes of care in there is a tendency to focus on reporting rather
order to create a safer system. For every major than on learning and on effectively responding to
incident that causes a patient actual harm, there the events detected. The healthcare system has an
are many other events such as “near misses,” obligation to the public to learn from process
unsafe acts, and precursor events, from which failures and adverse events. The failure to learn
learning and adaptation can occur [3]. The ability from mistakes is, unfortunately, a common char-
to capture and examine both harmful and “non- acteristic of the complex healthcare environment.
harm” incidents can provide enormous opportu- Mishaps and errors, even when reported, often do
not lead to the changes necessary to prevent their
J.A. Sanchez, MD, MPA (*)
recurrence and often miss the deep-seated sys-
Department of Surgery, Ascension Saint Agnes tems issues that enabled the adverse event to hap-
Hospital, Armstrong Institute for Patient Safety pen. Furthermore, when learning occurs as a
& Quality, Johns Hopkins University School result of an investigation, it is often not shared
of Medicine, Baltimore, MD, USA
within the institution or externally [3]. Root
cause analyses are often done in secrecy, and
even those involved in the incident being investi-
Foundation and Kyle John Rymiszewski Research gated are not privy to all the documents and
Scholar, Children’s Hospital of Michigan, learnings [5]. As a result, the same mistakes recur
Wayne State University School of Medicine, and patients continue to be harmed by prevent-
5057 Woodward Avenue, Suite 13001, Detroit,
MI 48202, USA
able errors. Providers become more jaded and
e-mail: [email protected] cynical and learning opportunities can be missed.

684 J.A. Sanchez and P. Barach
Incident reporting systems (IRS) have been consideration is to what degree the information
developed and used effectively in many other collected is structured, which facilitates the anal-
high-risk, safety-critical industries (see below). ysis of aggregate data, versus a narrative-based
The Institute of Medicine, in its report on patient approach which provides more contextual and
safety, To Err is Human, called for the widespread granular information but more difficult to aggre-
adoption of voluntary reporting systems through- gate data [10].
out healthcare in order to capture adverse events, In this emerging field of study, many defini-
near misses, and unsafe acts to improve quality tions are used and a common terminology has yet
and safety [6]. A robust IRS is an essential com- to emerge. For example, iatrogenic injury origi-
ponent of any patient safety program. It allows nates from or caused by a physician (iatros,
organizations to identify and learn from failures Greek for “physician”) [11]. However, the term
and share learning with others. The ultimate goal, has come to have a broader meaning and is now
however, is to actually improve care, and collect- generally considered to include unintended or
ing information without affecting change is itself unnecessary harm or suffering arising from any
an unsafe act for an organization. The main pur- aspect of healthcare management. Problems aris-
pose of any reporting system is to learn from ing from acts of omission as well as from acts of
experience and ensure process and outcome fail- commission are included. One of the more diffi-
ures do not recur [7]. To be sustainable, all IRS cult problems in discussing patient or medication
must trigger visible, useful responses to events. safety is imprecise taxonomy, since the choice of
Reporting incidents are only of value if useful terms has implications for how the problems
information is obtained and if the findings are related to patient safety are addressed [12]. This
able to be generalized in order to prevent similar makes the comparison of different studies and
harms in the future. Moreover, findings should be reports problematic. The lack of standardized
analyzed in aggregate for sensemaking to occur nomenclature and a universal taxonomy for med-
and to guide smart resource allocation decisions ical errors complicates the development of a
[8]. Identifying areas of concern, commonalities response to the issues outlined in the IOM report.
in causation, and following trends can help The National Research Council defines a
expand opportunities to redesign operational pro- safety “incident” as an event that, under slightly
cesses, workflows, and organizational structure. different circumstances, could have been an acci-
From this learning, a wide range of possible solu- dent. The word “accident” is intertwined with the
tions can emerge to mitigate or eliminate hazards notion that human error is responsible for most
and prevent the recurrence of incidents [2]. injuries [13]. This notion can be challenging since
judgments about human behavior retrospectively
are strongly influenced by hindsight bias. As such,
Types and Definitions of Incident the ability to classify events into a safety frame-
Reporting Systems work requires a standard set of definitions to facil-
itate the analysis of events and the aggregation of
The technology enhancements afforded by web- data [14–17]. There remain major variations in
based information systems make it an ideal plat- nomenclature with no fixed and universally
form for incident reporting. A number of different accepted definitions [18]. The International
types of electronic systems have been designed Classification for Patient Safety, developed by the
which take advantage of the ubiquitous nature of World Health Organization’s World Alliance for
the internet and of systems that interface with Patient Safety, offers definitions and concepts
each other in order to share data [9]. The goals consisting of ten major levels which are listed in
and objectives of a patient safety program deter- Table 40.1. Such a classification system facilitates
mine the design of a specific reporting system. learning across disciplines and organizations and
Factors such as whether reporting is voluntary or should be more widely adopted.
mandatory and whether anonymous reporting is Reporting systems may extend beyond the
allowed are crucially important. Another design boundaries of a single hospital or organization.
40 Capturing, Reporting, and Learning from Adverse Events 685
Table 40.1 Definitions Multicenter specialized systems have been

Safety Freedom from accidental injuries developed for settings such as critical care units
Error The failure of a planned action to and those which capture surgical and anesthesia-
be completed as intended (i.e., error related errors [19–21]. Some systems are limited
of execution) or the use of a wrong
to certain types of events such as the one from the
plan to achieve an aim (i.e., error of
planning). Errors may be errors of Institute for Safe Medication Practices and may
commission or omission and restrict access to certain types of clinical or
usually reflect deficiencies in the administrative personnel. Nationwide systems
systems of care
including the Sentinel Event system of the Joint
Adverse event An injury related to medical
Commission in the USA and the National
management, in contrast to
complications of disease. Medical Reporting and Learning System in the UK aim to
management includes all aspects of improve patient safety using a population-based
care, including diagnosis and approach.
treatment, failure to diagnose or treat,
and the systems and equipment used
to deliver care. Adverse events may
be preventable or non-preventable I deal Characteristics of Hospital-
Preventable An adverse event caused by an Based Reporting Systems
adverse event error or other types of systems or
equipment failure
Successful reporting and learning systems which
“Near miss” or Serious error or mishap that has the
“close call” potential to cause an adverse event
enhance patient safety have the characteristics
but fails to do so because of chance outlined in Table 40.2 [22]. A “reporting culture”
or because it is intercepted. Also is one which creates the psychological safety for
called potential adverse event individuals to timely report any incident without
Adverse drug A medication-related adverse event fear of reprisal and maintains the confidentiality
event
of patients and staff to the greatest extent possi-
Hazard Any threat to safety, e.g., unsafe
practices, conduct, equipment, ble. Individuals who report must be aware that
labels, names their reporting makes a difference. As events are
System A set of interdependent elements reported and validated, a response should be ini-
(people, processes, equipment) that tiated even if reporting is anonymous. It is pos-
interact to achieve a common aim sible to learn from even seemingly insignificant
Event Any deviation from usual medical
incidents and all events should be reported. The
care that causes an injury to the
patient or poses a risk of harm. awareness that reports are taken seriously by the
Includes errors, preventable adverse organization promotes an environment in which
events, and hazards (see also frontline workers are more likely to increase the
incident)
level of surveillance and reporting [23].
Incident (or Any deviation from usual medical
The analysis of reported events provides
adverse care that causes an injury to the
incident) patient or poses a risk of harm. insight into how all factors causing the event
Includes errors, preventable adverse converge so that steps can be taken to make the
events, and hazards system safer. Granular clinical information
Potential A serious error or mishap that has regarding events, particularly using a combina-
adverse event the potential to cause an adverse
event but fails to do so because of
tion of narrative and structured data, provides
chance or because it is intercepted fertile ground for identifying major categories of
(also called “near miss” or “close defects in the system. Additionally, the reporting
call”) system must be capable of disseminating its find-
Latent error (or A defect in the design, ings in a comprehensive and understandable way
latent failure) organization, training, or
maintenance in a system that leads
and make recommendations for change by
to operator errors and whose effects addressing the systems issues rather than target-
are typically delayed ing on individual or group performance [24].
Table 40.2 Characteristics of successful incident report- essential component of a patient safety program
ing and learning systems whether national or institutional
[25, 26]. The absence of such protection may
(Leape)
stifle the desire to report, even if reporting is
Nonpunitive Reporters are free from fear of
anonymous.
retaliation against themselves or
punishment of others as a result of In addition to the attributes noted in Table 40.1,
reporting good hospital-based reporting systems allow
Confidential The identities of the patient, reporting by anyone in the organization, includ-
reporter, and institution are never ing patients. Multiple sources of reporting pro-
revealed
vide richer, more granular contextual information
Independent The reporting system is
independent of any authority with
as opposed to a single source. Good systems par-
power to punish the reporter or the ticularly value the important role patients and
organization their family members play in improving safety.
Expert analysis Reports are evaluated by experts These systems also gain invaluable information
who understand the clinical regarding a patient’s experience and the needs of
circumstances and are trained to
recognize underlying systems
the community directly from the “voice of the
causes customer” perspective [25–27].
Timely Reports are analyzed promptly, and
recommendations are rapidly
disseminated to those who need to Fostering a Reporting Culture
know, especially when serious
hazards are identified
Systems Recommendations focus on As noted, there is pervasive underreporting of
oriented changes in systems, processes, or adverse events and near misses thereby perpetu-
products rather than being targeted ating the risk to patients and missing opportuni-
at individual performance ties to learn. In a completely open and just
Responsive The agency that receives reports is culture, incidents and failures are honestly dis-
capable of disseminating
recommendations. Participating cussed by all staff, patients, and families enabling
organizations commit to the causes of serious events to be established and
implementing recommendations lessons to be learned. Organizations with the best
whenever possible reporting culture go to great lengths to ensure
Resourcing Expertise and adequate financial
that reports and investigations carry no blame or
resources are available to allow for
meaningful analysis of reports liability. Top management in these healthcare
Legal protection When deidentified information is systems vigorously promotes the message of a
reported to a national incident “blame-free and nonpunitive” reporting environ-
reporting system, it is important to ment [28]. Additionally, feedback is given to
ensure that the information be
individuals who report on the outcome of an
given legal protection
investigation and what measures have been taken.
Data entry The need to optimize ease of use
interface and ensure relevant and adequate High reporting rates in organizations with a
data submission strong reporting culture do not necessarily indicate
inferior quality but, rather, an environment that
encourages the reporting of errors and adverse
To get the maximum benefit, events must be events. This “reporting paradox” gives the appear-
evaluated, categorized, and analyzed by individ- ance that the incidence of safety events is higher in
uals with expertise who understand both clinical these organizations. On the contrary, higher levels
context and are additionally trained to recognize of reporting allow an institution to integrate the
underlying systemic issues. Clinical personnel learnings derived into quality and safety improve-
with additional training in human factors, sys- ment efforts, focusing on system- level changes
tems engineering, patient safety, and other related leading to a safer healthcare environment [29].
fields are excellent candidates for these activities. It is essential to introduce norms in profes-
Legal protection for reporting should also be an sional schools and graduate training programs
that inculcate learning and nonpunitive safety barriers and incentives to reporting is the first step
reporting to have a sustainable impact on the (Fig. 40.1) [31]. Each healthcare organization has
future workforce so that a reporting culture its own unique set of characteristics, values, prac-
becomes second nature. In addition, heightened tices, and culture, all of which contribute to the
expectations from consumers, patient advocacy degree by which its workforce is willing to report
groups, regulators, and accreditors that errors and safety-related events [32]. As noted earlier, fear of
near misses are to be reported as a professional punishment or retribution is a particularly strong
obligation will contribute to the necessary culture factor, especially in rigidly hierarchical organiza-
change. tions. Reluctance to report may be bred at the
clinical microsystem, mesosystem, and even mac-
rosystem level depending on the group dynamics
I ntegrating Reporting Systems and culture of an organization as well as its lead-
with Other Patient Safety ership structure [33].
Surveillance The high-paced, high-tempo, and intense
nature of delivering high-quality healthcare cre-
No single approach to address patient safety will ates limitations in time as well as physical and
detect all adverse events. Incident reporting sys- emotional energy. Time constraints, pervasive in
tems are one of many ways to monitor and collect healthcare, are compounded by an absence of
information. Each approach by itself may not be communication with staff when safety issues are
sufficient to create significant change. As such, reported and by a general lack of acknowledge-
the ability to integrate the entire set of patient ment, encouragement, and positive feedback ulti-
safety activities in an organization allows for a mately demotivating frontline providers from
more robust, safety-focused approach. For exam- reporting. In one study, most respondents
ple, the abstraction of clinical data for purposes believed that lack of feedback was the greatest
of generating insurance claims may be also used deterrent to reporting [31]. At a minimum, feed-
to identify adverse events and possibly near back based on the findings from investigations
misses which can then be investigated. Analysis and analysis should occur. Ideally, it also should
of these data may allow an organization to moni- include recommendations for changes which are
tor and view events across different dimensions developed in collaboration with great input from
using AHRQ Patient Safety Indicators (PSI) and the staff. This approach emphasizes the impor-
with the addition of ICD-10 hospital discharge tance of open, honest, and timely communication
codes specific to medical errors [30]. and feedback [34].
An organization’s patient safety portfolio may The main reasons for not reporting events are
include such activities as direct observation related to fear of collegial reputation and blame, a
through routine “patient safety walk-rounds,” high workload, and a lack of clarity as to whether
medical record audits and focused reviews, work- an event should be reported [35]. Measures to
force safety attitude surveys, failure modes and increase the reliability of reporting include pro-
effects analysis (FMEA), and the use of the Global viding clear definitions of incidents (Table 40.1),
Medication Trigger Tool [30]. Additionally, a peri- simplifying the ease of reporting, and providing
odic review of an institution’s malpractice claims, ongoing education and feedback. In general, dif-
although subject to selection bias, may be useful in ferent types of IRS have inherent conflicts and
focusing attention on specific areas of concern. trade-offs (Table 40.3) which should be under-
stood in order to make the best use of the informa-
tion obtained.
Barriers to Reporting Reporting is only of value if it leads to mean-
ingful change. Failure to do anything about events
How can we transform the current culture of instills a sense of futility and discourages workers
blame and resistance to one of learning and at all levels from reporting. Safety awareness
increasing safety? Understanding the balance of becomes integral to providers’ work when an
Fig. 40.1 Barriers and incentives to reporting. Modified from Ref. [20]
organization is visibly willing to make fundamen- responsibilities and do not make patients safer.
tal changes in response to reported events [36]. Additionally, inabilities to access the reporting sys-
On the other hand, delays or a lack of response tem either by physical access, cumbersome com-
from supervisors and hospital leaders will dis- puter program rules and incompatibilities, or
courage an already beleaguered workforce from simply poor usability of the software interface also
reporting events, particularly near misses [37]. serve as impediments to reporting [38].
Meaningful analysis, learning, and dissemina-
tion of lessons learned require expertise in safety
systems, accident investigation, and human factors. Participation Bias
Faulty, incomplete, or lax analysis and interpreta-
tion and the application of ineffective, misguided, The rate of reporting and the types of error
or potentially unsafe processes may result in reluc- reported vary depending on job function. While
tance by frontline workers to report in the future nurses report a large proportion of all events,
particularly when ineffective fixes add burdensome these tend to focus predominantly on nursing
administrative tasks which detract from clinical processes. Physicians are much less likely to
Table 40.3 Common conflicts in reporting systems [20] it is important to recognize that aggregate data and
• Sacrificing accountability for information— trends generated from IRS may provide only a
Negotiating moral hazards in choosing between selective view depending on which type of health-
good of society compared with needs of
care workers actually report. For incident report-
individuals
ing to be useful, it must collect a representative
• Near-miss data compared with accident data—
Near-miss data plentiful, minimizes hindsight bias, account of all errors from a broad range of health-
proactive, less costly, no indemnity care workers regardless of role or status. This
• A change in focus from errors and adverse events approach is more likely to result in more accurate
to recovery processes—Recovery equals resilience; information and effective learning [40].
emphasis on successful recovery, which offers
learning opportunity
• Trade-offs between large aggregate national
databases and regional systems—National offers Anonymity Versus Confidentiality
longer denominators, capture of rare events;
regional offers potentially more specific feedback Anonymously reported data may be less reliable
and local effectiveness
and potentially less useful than its counterparts
• Finding right mix of barriers and incentives—
Supporting needs of all stakeholders; ecological
due to the limited ability to obtain more informa-
model tion and to ask specific questions of the reporter.
• Safety has up-front, direct costs; payback is This lack of accountability and transparency in
indirect—Spending “hard” money to save larger anonymous reporting, however, may be a neces-
sums and reduce quality waste sary trade-off during the early phases of institut-
• Safety and respect for reporters as well as ing a reporting system in an organization until
patients—A just culture that acknowledges
pervasiveness of hindsight bias and balances trust is established and reporting becomes habit-
accountability needs of society ual. Unless staff feel safe to report, it is likely that
• The need for continuous timely feedback that reporting of adverse event will only capture a
reporters find relevant; changing bureaucratic small number of process and adverse events.
culture—Critical to sustain effort of ongoing Confidential reporting, on the other hand, where
reporting
the reporter is identified but protected from any
reprisals, can yield more valuable information for
report except in cases of serious events [31]. analysis at the expense of underreporting by
Interestingly, a survey by Wilson et al. demon- those individuals who have not reached sufficient
strated that, although nearly all physicians levels of trust to report. Ideally, all reporting
believed that reporting should occur when a should be confidential and not anonymous, but
patient gets the wrong treatment, only about half this depends greatly on organizational culture,
thought that a report should be generated when a safety attitudes, and the risk of being blamed for
patient does not receive necessary treatment. reporting. Whether an anonymous or a confiden-
This difference is concerning since acts of omis- tial approach to reporting is employed, the suc-
sion are twice as common as acts of commission cess of a reporting schema ultimately depends on
in medical errors [39]. The contrast in reporting obtaining sufficient information to conduct a full
rates between nurses and physicians may indicate investigation in order to effect change [41].
different perceptions of what is an adverse event
as well as differing mental models and attitudes
regarding their professional roles and responsi- he Importance of Near Misses
T
bilities as part of a healthcare system. for Learning and Recovery
Other categories of healthcare workers may be
also unwilling to participate in incident reporting Most accidents are preceded by warnings or
depending on their level of involvement in direct events that forewarn of an impending system fail-
patient care and where they stand in the hierarchy ure resulting in patient harm [42]. However,
of the organization. Therefore, given the wide vari- because many responses to safety events are
ation of participation in reporting by job function, reactive and not proactive, it is not uncommon for
organizations to wait for events to occur before marked decreases in reporting [50]. Billings, a
taking steps to prevent a recurrence. physician who led the effort to create the ASRS
Near misses and other precursor events occur in 1976, stresses the value of learning with mini-
much more frequently than actual harm and, as mal indemnity [51].
such, offer ample opportunities for learning. We Risk management in aviation illustrates how
define a near miss as any event that could have had organizations learn by applying near-miss infor-
adverse consequences but did not and was indis- mation to augment the sparse history of crashes
tinguishable from fully fledged adverse events in and injuries. Data from IRS have been used
all but outcome. There exists a continuous cascade effectively to redesign aircraft, air traffic control
of adverse events from apparently trivial incidents systems, airports, and pilot training programs
and near misses to full-blown adverse events [43]. reducing human error. An overarching lesson
The same etiological patterns and relationships from 35 years of aviation experience is that the
exist which precede both adverse events and near data collection methods and structures can be
misses [44]. Only the presence or absence of used to simultaneously maximize confidentiality
recovery or blocking mechanisms determines the and optimize bidirectional information flow [52].
actual outcome. It could be argued that focusing Schemes for reporting near misses, close
on near-miss data can add significantly more value calls, or sentinel (i.e., “warning”) events have
to quality improvement than a sole focus on been institutionalized in aviation, nuclear power,
adverse events [45, 46]. petrochemicals, steel production, and military
Near misses are ripe learning opportunities operations [51, 53–55]. In healthcare, efforts are
and reporting them can have a considerable now being made to create medical near-miss
impact on the safety of patients. Although near- incident reporting systems to supplement the
miss events are often ignored, reporting incidents limited data available through mandatory report-
not resulting in harm may be easier to report from ing systems focused on preventable deaths and
a psychological perspective if the learning oppor- serious injuries.
tunities are recognized. Reporting these types of
events also helps to promote an open reporting
culture whereby everyone shares and contributes Nuclear Power Safety Systems
information to enhance patient safety.
In the highly charged political, financially
accountable, and legal environment of the nuclear
viation Near-Miss Reporting
A power industry, no penalties are associated with
Systems reporting non-consequential events, or “close
calls,” to the Human Performance Enhancement
The decade-long aviation effort to improve safety System. In the nuclear power industry, near
through system monitoring and feedback holds misses are referred to as “accident precursors”
many important lessons for healthcare [47]. [56]. Feedback from the Accident Precursor
Public accident investigation and confidential Program is felt to greatly contribute to a strong
near-miss analyses have been complementary safety record for the nuclear industry over past 25
elements in the remarkably successful effort to years [57]. This has been achieved by mapping
improve air safety [48]. After three decades, over events on fault trees using probabilistic risk
500,000 confidential near-miss reports (currently assessment analysis (PRA) [58, 59].
over 30,000 reports annually) have been logged The Three Mile Island disaster led to the
by the Aviation Safety Reporting System (ASRS) emergence of industry-wide norms which sup-
[49]. Eligibility for limited immunity for non- ported a communitarian approach to regulation
criminal offenses is a powerful incentive to [60, 61]. The dread of even a single potential
report. Cracks in the framework of trust among catastrophe and its implications for all industry
aviation stakeholders have been associated with members outweighed any objection to
IRS. Backed by public and communal pressures, petrochemical processing, for example, uses
local proactive safety methods were institutional- seven quality indicators to assess the effective-
ized and put into effect across the industry. The ness of reporting systems while also highlighting
intensified approach to process improvement the fairness, the revenue optimization, and the
through a focus on safety led to financial gains as cost-effectiveness of the program [62, 63].
a result of better power production (i.e., fewer Reporting system leaders believe that these sys-
power outages, shutdowns, and reductions in tems not only reduce waste but are highly cost
capacity) [61]. As in aviation, nuclear power inci- effective [64]. This is similar to the implementa-
dent reporting has evolved to capture the subtlest tion of new worker safety climate laws where
information using a nested systems approach companies required to embrace the safety rules
with confidentiality and other protections increas- of the occupational safety health administration
ing in proportion to the sensitivity, value, and dif- have discovered the profits which accompany a
ficulty of obtaining necessary information. healthy workforce [65].
Near-miss analyses follow the same proce- Evidence-based medicine and improvement in
dures as actual harm investigations and should be outcomes are accelerating the translation of les-
subjected to the same rigorous root cause analy- sons learned in other domains to the healthcare
sis methodology in order to identify the system field over the past decades. Studies of IRS from
and human factors which contribute to events. It nonmedical domains hold promise for catalyzing
is important to note that, since they occur much a shift in the healthcare culture from a punitive to
more frequently, reporting and thus investigating a collaborative mindset that seeks to identify the
these types of events may overwhelm the capac- underlying system failures [66, 67].
ity of an organization to respond fully. Reporting
these incidents without having the capacity to
respond is a waste of an organization’s time and Conclusions
resources.
Analysis of near misses over adverse events The systematic identification of defects in pro-
offers advantages: (1) near misses occur three to cesses of care that lead to medical harm and their
three hundred times more frequently enabling systematic evaluation allow healthcare systems
quantitative analysis; (2) fewer barriers exist to to understand and develop corrective strategies
data collection allowing the in-depth analysis of for reducing harm. Incident reporting systems
interrelationships in small failures; (3) recovery that capture these events and allow an under-
strategies can be studied to enhance proactive standing of the root causes of errors, particularly
interventions and to de-emphasize the culture of if they include “near misses,” are the hallmarks of
blame; and (4) hindsight bias is more effectively successful patient safety programs and key to
reduced. Near-miss events offer powerful remind- meaningfully improving safety. Nonpunitive,
ers of system hazards and retard the process of protected, voluntary incident reporting systems
forgetting to be afraid and reinforce a continuous in high-risk nonmedical domains have grown to
preoccupation with failure [31, 45]. produce large amounts of essential process infor-
mation unobtainable by other means. Reporting
systems across industries have evolved over the
Costs Versus Benefits of IRS past three decades to emphasize identification
and analysis of near misses in addition to adverse
Many high-risk fields such as nuclear power events. They encourage confidentiality over ano-
technology, aviation, and petrochemical process- nymity and a move beyond traditional linear
ing have shown that implementing incident thinking about human error toward a multiple
reporting systems for near misses is essential causation understanding at the level of systems.
because they benefit their organizations much These programs offer important and timely les-
more than they cost. The system developed for sons for healthcare.
For healthcare reporting systems to function 10. Barach P. The impact of the patient safety movement
on clinical care. Adv Anesth. 2003;21:51–80.
well, incentives must exist which promote volun-
11. Cited in the Oxford Dictionary, Oxford University
tary reporting—completely, confidentially, and Press, London, 1989.
objectively. Reporting should be the right, easy, 12. Nebeker J, Samore M, Barach P. Clarifying adverse
and safe policy for all healthcare professionals drug events: a clinicians guide to terminology, docu-
mentation, and reporting. Ann Intern Med.
regardless of outcome. To maximize the usefulness
2004;140(10):1–8.
of IRS, there will be a need to balance account- 13. National Research Council, Assembly of Engineering,
ability, system transparency, and protections for Committee on FF Airworthiness Certification
reporters. To ease implementation, all stakeholders Procedures. Improving aircraft safety: FAA certifica-
tion of commercial passenger aircraft. Washington:
in the healthcare community must be involved in
National Academy of Sciences; 1980.
system oversight, support, and advocacy. The top 14.
Runciman WB, Williamson JA, Deakin A,
priority must be to design systems geared to pre- Benveniste KA, Bannon K, Hibbert PD. An inte-
venting, detecting, and minimizing the effects of grated framework for safety, quality and risk man-
agement: an information and incident management
undesirable combinations of physical design, orga-
system based on a universal patient safety classifica-
nizational performance, and circumstances. tion. Qual Saf Health Care. 2006;15 Suppl
1:i82–90.
15. World Alliance For Patient Safety Drafting Group,
Sherman H, Castro G, Fletcher M; World Alliance for
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How Not to Run an Incident
Investigation 41
Bryce R. Cassin and Paul Barach
“If you don’t inquire in a way that respects the intelligence of the other person, you
probably won’t find many insights.”
—Gary Klein, Seeing What Others Don’t, 2013
from everyday practice in the perioperative set-

on’t Let the Investigation Get
D ting but a functional tool for discovering fresh
in the Way of Learning from People insights about the challenging aspects of the local
clinical workplace in context [1]. Local experi-
Incident investigation is an integral feature of ence and expertise are important factors in shap-
perioperative surgical safety programs and is ing a culture of good clinical judgment and
likely to be fundamental in directing future initia- decision-making [2]. However, clinicians remain
tives. Advances in clinical practice and biomedi- ambivalent about incident investigation pro-
cal technology make the challenge of doing cesses and tend to find more value in the informal
effective incident investigation more complex debriefing conversations that start up after an
and nuanced. There is a palpable distance adverse event across the organization. Perhaps
between the stable incident investigation activi- the establishment of local review meetings and
ties of quality and safety departments and the departmental debriefings is the most vital aspect
continually evolving scope of surgical practice of any incident investigation process. A good and
necessitating increasingly risky and complex timely debrief shifts the conversation from a ret-
procedures, requiring clear communication rospective search for isolated causes to a pro-
across clinical disciplines, and ongoing adjust- spective exploration of patterns and cues in the
ment to the subtle changes in workplace local clinical workplace that emerge from every-
conditions. day activity over time [3–6].
Incident investigation should not be a remote Nonetheless, it is commonplace for hospitals
activity of senior management disconnected and health service providers to use structured
methods for the analysis of adverse events, the
determination of contributing factors, and the
B.R. Cassin, RN, BA Hons (Class 1) (*) implementation of corrective actions to improve
School of Nursing and Midwifery, Hawkesbury the safety and performance of clinical systems
Campus, Western Sydney University,
Locked Bag 1797, Penrith, NSW 2751, Australia
(e.g., root cause analysis in combination with
e-mail: [email protected] human factors engineering). Incident investiga-
tion typically involves a broad range of tech-
Clinical Professor, Children’s Cardiomyopathy niques for gathering and arranging the facts that
Foundation and Kyle John Rymiszewski Research relate to adverse events into a report that catego-
Scholar, Wayne State University School of Medicine, rizes areas of breakdown and vulnerability in the
5057 Woodward Avenue, Suite 13001, Detroit,
MI 48202, USA
interactions within a clinical micro-system [7, 8].
e-mail: [email protected] Investigation methods have become systematized

696 B.R. Cassin and P. Barach
and organized over time around a predetermined lessons they learned from the case and will apply
set of procedures to produce the required data going forward. Notably, the trauma physician
[9]. However, it does not follow that incidents was more interested in improving the quality of
need to be investigated according to a fixed insights generated from the local conversations
scheme. Above all, clinicians need to have the between respected clinicians about the case than
authority and inclination to shape the investiga- the investigation process and its detailed methods
tion process to achieve the ends that they most and regulatory requirements.
value in their particular workplace [10, 11]. In retrospect, the measure of each investiga-
tion at the facility was the personal qualities and
approach of the investigation team and the col-
A Surgical Trauma Case lective wisdom of the local clinicians. Over the
last two decades various techniques and meth-
The insights drawn from the experience of facili- ods for incident investigation have been tested in
tating nearly 200 incident investigations in a the acute clinical settings of surgical depart-
medium sized health service in the outer suburbs ments (e.g., root cause analysis, common cause
of a large urban center in Australia underpin the analysis, cognitive human factors, failure modes
observations presented in this chapter [10, 11]. and effect analysis, critical incident review, risk
One particularly illuminating investigation dem- analysis, and review of morbidity data). None
onstrates how the ideas and setting for an inci- should be viewed as a prescription or a system,
dent investigation evolved from a top-down to a but a set of tools to be adapted, updated and
bottom-up process. revised with each new adverse event by well-
The case concerned a 25 year-old male informed clinicians. Perhaps the best advice to a
brought into the emergency department by ambu- prospective investigation team is not to see the
lance following a high speed motorbike accident. adverse event in isolation but a group of clini-
The patient was assessed by the trauma team on cians busily going about their work as they
arrival to be in profoundly shock with a bleeding would on any given day. This is the art of inci-
wound to the left upper thigh and chest. Chest dent investigation, no matter the method selected
tubes were inserted and intravenous fluids com- to analyze the event [12].
menced. The patient was transferred to the oper- The experience of working with different inci-
ating room for surgical management of internal dent investigation teams highlights the impor-
injuries and pelvic vascular injuries. During sur- tance of good governance, transparency and
gery the patient deteriorated and required resus- authentic leadership within the surgical depart-
citation, which was unsuccessful, and the patient ment and hospital. This will enable a department
expired. The case involved clinicians across dis- to move away from the zealous insistence on a
ciplines and departments from various special- particular system for investigation and direct
ties. The initial response, preparation for surgery, attention to the thoughtful and timely triage of
and overall management were discussed at a events, the selection of an appropriate team, and
multi-department Trauma Meeting. The case was combination of methods, according to the goals
referred for a root cause analysis (RCA) investi- and needs determined by the local conditions and
gation. The investigation team included a trauma context. Validation of the incident investigation
surgeon, general surgeon, intensive care special- will be demonstrated by the relevance of the find-
ist, orthopedic surgeon, a perioperative nurse, ings to local clinicians and managers (What
and trauma nurse. The trauma physician led the Weick refers to as their “clinical sensemaking”
team and the patient safety manager facilitated [13, 14]). For the investigation of an adverse
the investigation. What makes the case interest- event to be rendered meaningful the findings
ing is the broad representation of clinicians from need to relate to a concrete situation where pat-
the perioperative setting, and the leadership from terns of action are recognizable [1]. This is
the trauma physician who used the opportunity to crucial for the construction of a legitimate expla-
get clinicians around the table to talk about the nation that has integrity in the local workplace.
41 How Not to Run an Incident Investigation 697
An investigation report that makes sense to cratic search for the root causes or a single
people in context is more likely to stimulate fur- explanation has the tendency to give investiga-
ther conversation and action over time [1]. tion teams and health care administrators the
The dynamic conditions of the surgical envi- imp ression that a description of specific
ronment and the human factors related to the per- causative factors must and can reliably be

formance of surgical teams warrant specific applied to the health system as a whole (e.g., the
attention. Incident investigation tools and meth- establishment of classification systems and tax-
ods need to be assessed and constantly adjusted onomies of serious adverse events; [18]). The
for their fit and applicability to local conditions. contrasting reality is that the safety and perfor-
The skill of commissioning an investigation is a mance of a perioperative environment is the
matter of clear perception of the character of the product of the continuous flow of small everyday
people selected for the investigation team, and an adaptations and course corrections from multi-
appreciation of the available resources given the ple people within the surgical workplace in
organizational climate. It requires a developed response to the ongoing technological pressures,
capacity for understanding the human predica- transformations and system level developments,
ment of clinical work, and an ability to assess an such as introduction of new electronic medical
unexpected event on a continuum, as a set of cir- record systems, that shape the level of complex-
cumstances in the ongoing flow of activity in the ity and inherent patient risks [6, 19].
clinical workplace [15]. Even though the situa- There is an acute need to move away from the
tion was not personally encountered, a senior cli- Newtonian assumption that the investigation of a
nician who knows their department and staff will past event will arrive at a stable explanation, or
seek to understand the challenges the situation that the perioperative environment operates in a
presented to the people involved, when tasked stable state according to an automated set of
with commissioning an investigation team. He rules [8]. Commonly used investigation tech-
will first and foremost work to establish trust in niques such as root cause analysis may create an
the process and create a sense of safe space that appearance of order, but the findings of a single
allows open and uninhibited conversations about investigation are rarely, if ever, indicative of
how best to learn from the adverse event [16]. safety and performance at a systems level [8].
This is due to the properties of system complex-
ity and the difficulty of reconstructing events
Define Your Purpose post hoc in the clinical setting using the standard-
ized language of incident investigation models.
The investigation of adverse events should be Organizational life is continually being shaped
organized around the surgical workplace culture, by unintended, unexpected and unknown factors
the organization of surgical space and schedules, that result in both positive and negative outcomes
the impact of perioperative work on human per- [14]. A comparison of the common assumptions
formance, and the potential for learning from the behind the US Veterans Affairs National Centre
adaptations that surgical teams and perioperative for Patient Safety (NCPS) RCA process [20, 21]
staff make in order to recover from unexpected and the human factors approach described by
events [15, 17]. The extent to which local adap- Dekker [8] highlights the impact that contrasting
tation and the fitness of the selected investiga- mental models can have on event perception (see
tion method impact on the meaningfulness of the Table 41.1).
inquiry for making sense of surgical adverse Developing insight into the way complex
events should not be under-estimated [10, 11, 14]. human systems interact and making connections
Living with uncertainty and ambiguity contrasts within perioperative environments requires a
the demand from administrators to account for shift in mindset about the knowledge generated
the facts related to an adverse event with a plau- from incident investigations [19]. Techniques
sible explanation [15]. The misguided bureau- like root cause analysis originate from industrial
Table 41.1 The level of event reconstruction possible in the local work context can vary somewhat from the assump-
tions made in formal incident investigation models
Common assumptions in RCA The local reality
The investigation team displays a thorough The information gathered by the investigation team is partial
understanding of the event through the rational and incomplete
presentation of information
The purpose of an investigation is to establish a There is no single authoritative account of an event as the
reliable account of what happened and why it analysis of what happened is influenced by the emerging
happened mental models of the people involved and interpreted through
the collective wisdom of the investigation team
The investigation team’s task is to demonstrate The findings of an investigation team are tentative and
cause and effect relationships and develop recommendations need to be confirmed in the local setting
corrective actions that address each root cause because it is not possible to capture all possible consequences
or contributing factor of an event or anticipate all future possible situations where a
similar event may occur
The incident investigation system takes into The consequences of an event are related to subjective factors
consideration the concerns of frontline personnel that operate deep within the workplace independent of rational
and is a tool for learning through the statements in incident investigation reports. Therefore, all
dissemination of positive actions that reduce or conclusions remain open to review and require ongoing
eliminate vulnerabilities identified dialogue in the workplace
settings where, typically, the contributory fac-

tors to a defect in a stable system can be attrib-
Cautionary Word About Methods
A
uted to a limited number of physical causes. The
of Inquiry
nature of clinical adverse events is such that it is
Most of the frustration with adverse event data
near impossible or exceedingly rare to frame an
and the slow progress with making changes in
investigation around a single procedure or
response to incident investigations can be related
device. Human error is even more problematic as
to either relying too heavily on a particular
it is hard to link individual actions to discrete
investigation technique to draw conclusions, or
properties of a broken system [6, 8]. Rather than
to making incorrect assumptions about the pur-
argue for a best method of incident investigation,
pose of an inquiry. The trajectory of a serious
the chapter presents a number of related proposi-
adverse event is unique and unlikely to occur
tions that can be used to make decisions about the
again in exactly the same pattern. Meta-analyses
most appropriate combination of tools that will
of RCA report data make the assumption that
help make sense of an adverse event. In contrast
common factors can be categorized and aggre-
to the assumptions of Newtonian rationality about
gated across multiple (often high risk) clinical
the universal application of methods, the guiding
adverse events without due regard for the contex-
premise is that an investigation team needs to
tual factors that were particular to individual
understand an event within the context of the
cases on a given day in a specific perioperative
operating environment and adapt the selection of
setting with a particular surgical team [23].
tools and techniques accordingly [22]. The
Aggregated RCA data, consequently, has little
approach represents a shift away from assuming
predictive value for future adverse events. This is
that there are broken properties to fix, to shaping a
challenging for regulators, risk managers, and the
perspective of the event that best fits the nature of
public to appreciate. Separated from the original
the problematic situation, and directs sparse orga-
context of action, system level aggregations of
nizational attention and resources towards the
event data become a “cumulative mess” through
methods of inquiry that will provide a useful
the multiplication of known causes and effects [18].
explanation.
When external governing bodies make these

assumptions they tend to work from a basic set of
definitions for the purpose of systematically
organizing the consequences of multiple adverse
events into categories within a measurable body
of knowledge (e.g., incident management and
reporting systems). At a universal level, the ques-
tions posed by regulators relate to what can be
known generally about adverse events and clini-
cian’s performance.
In contrast, clinicians deal with everyday
interactions in context and relate knowledge con-
struction to the dynamic of particular situations
[5]. In order to address what is known or unknown
about the risks and vulnerabilities in the periop-
erative setting methods are needed that enable
Fig. 41.1 Different inquiry methods produce different
the discovery of previously unrecognized prob- types of knowledge
lems (e.g., failure modes effect analysis, fault
tree analysis, and probabilistic risk assessment)
[24]. Questions at a contextual level relate to ation, is highly context dependent, and mediated
gaining a better understanding of operational through a process of translation by multiple peo-
matters across a department. When making sense ple at different levels across the organization (For
of an adverse event it is important to find out a thorough analysis of knowledge transfer, see
what was known about the particular problematic [25]. Cook and Woods [19], discuss the impact of
situation by the people involved. An incident resources and constraints on knowledge at the
investigation draws on the experience of people point of care delivery in complex systems).
working on the frontline in the clinical setting in
order to reconstruct the event.
In summary, the three different ways of know- uilding a Body of Knowledge
B
ing represent three basic approaches to construct- About Adverse Events
ing knowledge about adverse events:
Although root cause analysis was introduced into
1. Knowledge as transferring data. Policy mak- health care for the investigation of serious clinical
ers and regulators look for what is known gen- adverse events, it uses causal reasoning from sta-
erally, from aggregated reports, ble categories to deduce what happened (i.e., root
2. Knowledge as learning about systems. Peri cause analysis works from categories of what is
operative suite quality and safety programs generally known to break an event into knowable
seek to discover what is unknown or better parts). The view of the system is drawn from a pro-
understand known risks, and cess of deduction from known factors. Curiously,
3. Knowledge as an ongoing dynamic. Local the root cause analysis checklist of questions used
incident investigation teams work with what is by the US Veteran’s Administration (and adopted
knowable about an event from the circulating by other countries such as Australia) is labeled as a
information about everyday clinical actions. set of human factors questions, but the method is
unlike most human factors investigations due to a
The points of intersection in the diagram focus on identifying specific causation and apply-
(Fig. 41.1) represent the current state of knowl- ing fixed categories in relation to multiple aggre-
edge about actual or potential problems. In gated events [23, 26]. Without knowing the
practice, knowledge varies from situation to situ- consequences for the local clinical workplace, and
how the people involved defined the situation, error within health care systems need to be chal-
there can be no meaningful understanding of the lenged due to an over reliance on rational analy-
event and the depth of analysis is limited [18, 19]. sis as a basis for understanding breakdowns in
In terms of the way knowledge is produced, care delivery [29]. The initial implementation of
most adverse event investigations fit between two safety improvement programs introduced struc-
antithetical positions: either there is a specific tured processes for thinking about the causes and
“root” cause to find and sort into causal statements contributing factors to adverse events. As health
for corrective action according to a standardized departments and jurisdictions accumulated data
hierarchy imported from other industries [9], or about findings from RCAs assumptions were
they opt for the alternative, that a clinical adverse made about the transferability of what was known
event is the outcome of multiple contributory fac- about past events from generalized data aggre-
tors that are open to explanation from different gated from multiple RCA reports [23]. Informal
perspectives particular to the complexity and con- corridor conversations about care lack the appar-
text of the situation [15]. The separation of human ent rigor of rational management sanctioned inci-
factors in an event from system issues, under the dent investigations. The inherent risk in the
label of “human error” is arbitrary, reflecting a pursuit of more reliable adverse event data is the
misguided commitment to investigation methods paralysis of knowledge transfer at the local level
adopted from engineering without regard for the which is the most important level for developing
interplay between expertise and situational conan understanding of how people manage con-
straints in complex clinical environments [4, 6, straints and regain control of unexpected events
9, 19]. The selection of method often says more [6, 30]. A philosophical commitment to the pre-
about the purposes and philosophy of the investi- vention of adverse events feeds into a belief that
gation team and the sponsor of the investigation systems are generally consistent and reliable. The
than the event itself [26]. The choice of response reality is rather different in complex clinical sys-
to an adverse event will to a large extent deter- tems. Accepting that good people sometimes
mine whether the investigation team seeks to make poor judgments and decisions is more
replace broken components of a system, identify likely to lead to an understanding of the inconsis-
a barrier to prevent recurrence, consider the rede- tencies that are common in everyday human
sign of particular tasks, or to optimize workplace interaction with complex clinical and organiza-
systems by developing a better understanding of tional systems [30].
what people do at the local level [27]. In order to manage this dilemma it is neces-
sary to consciously reflect on the models that the
perioperative department selects to guide inci-
n Overreliance on Rational
A dent investigation [26]. If the department is pri-
Analysis Paralyzes Local Knowledge marily concerned with external reporting there is
likely to be a focus on identifying the organiza-
Top-down quality and safety processes have been tional factors related to adverse events. A limi
implemented in all major health care systems for tation of this risk averse approach is that
the management of adverse events. The situation perioperative care directly depends on what
in health care a decade ago was that decision humans do each day in the operating room envi-
makers needed to be mobilized to turn the idea of ronment where only the indirect impact of orga-
the patient safety movement into an organiza- nizational decisions are seen. Health care is quite
tional reality [28]. There is a growing body of different to other industries and trying to identify
literature that documents the implementation of a rational explanation for interaction in human
the resultant processes such as root cause analy- systems can be problematic and over reaching.
sis (RCA) for the investigation of serious adverse Clinical work involves a level of complexity not
events [5]. However, the assumptions about using encountered in stable closed systems where inci-
retrospective approaches to locate patterns of dent investigation heuristics such as the “Swiss
cheese model” originate [26, 31]. It is a constant decisions about the process for engaging staff
challenge to resist the management imperative to and providing feedback, and how to support the
produce normative incident investigation data clinicians involved in the adverse event. It will
about what happens in the operating room. A also shape the type of information gathered from
contrasting focus on the original concerns that investigation reports. These factors are important
guided local clinicians to initiate an inquiry into in shaping the debriefing session format with
an adverse event will enable the development of local perioperative staff following the adverse
measures that are the most meaningful and most event and its investigation. Questions should
likely to gain the trust of clinicians in the findings relate to a specific context where particular cues
[26]. Incident investigation models that aim to and patterns make sense and are recognizable [2,
develop insights about an adverse event that 26]. This approach will help guide future
inform the local clinical operating system look at decision-making and judgments when faced with
all aspects of human and technological interac- similar situations and also engender trust in pres-
tion with the perioperative suite. Asking how ent and future deliberations by management.
local systems fit together and the nature of local
constraints on perioperative care will provide a
more dynamic and contextually sensitive How to Run a Local Investigation
approach to guiding incident investigation [26].
A systemic model of investigation shifts attention The decisions about the process and techniques
from what is already generally known to identify- for analyzing adverse events are best made at the
ing what is knowable within the organization at local level where investigation teams reflect the
the time of the event [27]. This is a hugely impor- workplace culture of the surgical center, its
tant distinction that is often lost on regulators. human resources, and the mix of perioperative
The selection of an incident investigation activities [32]. Many health facilities and their
model will inform how the organization chooses surgical centers will have established structures
the types of incidents to be investigated, makes for clinical governance and processes for the
Table 41.2 Triage questions and key decision points to consider when setting up an investigation that will facilitate
and support the team process within the facility
Triage questions Key decision making points
What is the political landscape Evaluate the existing process for the investigation of adverse events, and the
for inquiry? track record at the facility
Is the inquiry within the scope Select techniques from the available toolkit at the facility and for which there is
of your facility? local expertise and experience
Who will commission a team? Establish a core group of experienced investigators/senior clinicians to appoint
a team leader and the advise team
Who will lead the team? Identify a senior clinician with clinical currency in the facility who is not
involved in the event under review
Who needs to be on the team? Appoint an investigation team with the requisite knowledge of the clinical area,
balancing representation across disciplines and clinical specialties, from staff
not involved in the event under review
Who is responsible and Determine the number of investigation team meetings required and the
accountable for which actions available time for each meeting
during the investigation? Define the internal and external team reporting requirements, including who
signs off on the final report
Identify who will endorse the investigation team findings, allocate resources
and support the implementation of the team recommendations across the
organization
Set a timeframe to evaluate the effectiveness and impact of any proposed
changes to practice
Organize debriefing sessions with different groups of staff at regular intervals
to provide timely feedback
investigation of clinical adverse events. A partic- Framing the Investigation Process

ular method of inquiry (e.g., root cause analysis)
is not prescribed here. Table 41.2 describes a The investigation needs to be flexible with the
commonplace approach (based on ref. [26]) that amount of time allocated tailored to the complex-
could be adapted as a triage tool for use in a range ity of the event, recognizing if similar events
of settings to investigate different events: have been investigated in the past. This may
shorten the current inquiry. Key tasks include
establishing a timeline or chronology, analyzing
Risk Assessment and Triage contributing factors to the event, and taking
existing and related care delivery problems in the
Standard incident risk matrices rate an event in facility into account. It is not always possible to
terms of the severity of injury to the patient and identify specific causal factors. The team needs
the likelihood of recurrence of the event type. to consider where the greatest benefit might be
There is a need for some level of triage beyond obtained in making recommendations. This was
the risk assessment stage where experienced evident in the trauma case, where the trauma
local senior clinicians not involved in the event physician leading the investigation team had the
determine what aspects of the situation warrant foresight to recognize that there would be consid-
the most attention. The emphasis when making erable benefit in having the senior clinicians on
the decision is the knowledge of previous and the investigation team interviewing local staff
current relevant challenges in the perioperative and reflecting with their peers on recent practices.
environment. In the trauma case above this was
particularly relevant. The trauma physician at the
facility had the foresight to convene an investiga- sking Questions and Gathering
A
tion team with the necessary senior expertise and Information
experience to evaluate the trauma call system, the
escalation process for medical review, the roles Beyond establishing a basic chronology of an
and responsibilities of the trauma team once the event it is useful to identify what activities people
patient arrived in the operating room, and high- were engaged in at the time of the event (see
lighted the importance of the trauma team leader Table 41.3). It is essential to gather information
in setting care priorities [33]. directly from people involved in the event close to
Table 41.3 Asking key questions that help to analyze the constraints on normal operations at the time of the event
helps to situate the actions of people in a specific and naturalistic context
Constraint Questions to unfold everyday thinking
Expectations What was the expected outcome of the clinical intervention or activity for the patient
in the perioperative environment?
Professional standards What were the normal parameters or standards that clinicians were expected to follow?
Expertise and experience What were the reasonable limits on human performance at the time? Were people
working outside of their usual roles?
Work environment How did the people who were involved in the event identify cues and make sense of
their work environment?
Protocols and procedures Were there any obvious adaptations of the normative care protocols that were deemed
necessary at the time?
Teamwork Were people working independently or did the activity require some level of teamwork
and cooperation?
Attention Where did people focus their attention and what was pointedly ignored by people in
the situation? What competing demands did people need to negotiate in order to
participate in the activity?
Perception What perception did people have of evolving changes in the immediate physical
setting as the event unfolded?
the time of the event as this will increase the uncertainties of why actions made sense at the
opportunity to capture the immediate perceptions time of an event. Making assumptions based on a
of what happened and what operational con- standardized checklist of trigger questions [9, 21]
straints needed to be negotiated [26]. The delivery runs the risk of not allowing the team to capture
of perioperative care is increasingly complex and the nuanced perceptions of people and the variety
contingent on the interaction between multiple of valid perspectives that can be derived directly
team members and departments that make many from contextual information about the unfolding
adjustments to routine everyday activity and con- unexpected situation [14].
tinually adapt to less than optimal conditions in Notably, during the trauma case, the senior
order to provide safe and quality care. clinicians on the team considered that the task of
A more nuanced and tacit understanding of categorizing the relevant factors was the remit of
what the people involved were thinking at time the patient safety manager facilitating the pro-
can be obtained by asking them to retrace their cess. The majority of the team conversation was
actions while speaking out loud their assump- dedicated to a detailed analysis of local systems
tions and their perceptions of the situation as it and the development of insights based on com-
developed [34]. This “think aloud” approach parison with the team’s broad experience with
enables people to talk about things they usually similar problematic trauma presentations.
would not verbalize (e.g., thoughts, feelings, rea-
soning, and expectations) [35]. Thinking out
loud can provide useful information about how Identifying Contributing Factors
people interpret their environment and the con-
straints operating in the workplace at a specific Consulting senior management at the facility
point in time. Moreover, it situates events back early and often in the investigation process and
into the messy flow of workplace activity [6]. developing a formative picture of what type of
practical recommendations could realistically be
implemented as an outcome of the investiga
Facilitating Team Meetings tion increases the likelihood that recommended
changes will be taken seriously and implemented.
The investigation team will need to consider how Talking with management also reduces the risk
information will be shared in face-to-face meet- that an adverse event might be investigated in
ings as well as online in a secure manner. isolation from other safety improvement activity
Clinician demands need to be weighed carefully in the department or across the hospital. If con-
when determining where and how often the teams trols and corrective actions were put in place for
need to meet and for how long. The team meeting a similar event, this is vital information for the
ideally will have a facilitator of the investigation investigation team. Arbitrary systems for decid-
process and a senior clinical team leader to guide ing whether a risk is to be mitigated or removed
the clinical conversation. The individual team are too disconnected from the complex and con-
members each bring their own set of experiences tinually changing nature of the perioperative
and levels of expertise to the investigation. clinical setting. It is a false and dangerous assum
Rather than the team engage in a retrospective ption that risks in health care can be removed or
flow charting process that is prone to hindsight errors completely prevented [29]. The nature of
bias due to knowledge of the outcome of the working in human systems is such that this level
event, it is more productive for the investigation of predictability does not exist in a reliable form.
team to put the available information from people Recommendations that result from an incident
involved in the adverse event back into the con- investigation must be tested and trialed in the
text of the unfolding situation as it was experi- clinical setting [36]. This can be via formative
enced [6, 8, 26]. This approach directs the feedback from the frontline clinicians or through
inquiry toward capturing the complexities and simulation prior to implementation, depending
on the level of complexity of the activity [37]. as investigating the process failures that led to
Simulation is an incredibly useful and visual the adverse event. Feedback following an investi
form of event analysis. Whether using desktop, gation and the implementation of strategies to
task trainer or a high fidelity surgery simulator, it implement change is not well managed [5].
can highlight the breakdowns in human perfor- Providing ongoing feedback to staff in a com-
mance and errors in the use of technology during pletely transparent manner with an interest in the
the event [38, 39]. The simulation helps ensure event at strategic points during the investigation
all members of the investigation team as well as and debriefing after the completion of the inves-
management understands what actually occurred tigation is essential if the analysis is to penetrate
during the event and how the team performed [40]. the local clinical workplace culture and lead to
entrusting future communications [15, 17, 42]. It
is additionally important to evaluate the process
The Investigation Report followed by the investigation team and to mea-
sure how effective the recommendations made
The team report describes the process and out- by the investigation team were in addressing the
comes of the event, contributing factors, recom- challenges related to the original situation. The
mendations, and strategies for implementation, debriefing needs to focus on the aspects of the
with timeframes for review and evaluation. It problematic situation that warrant the most
should be acknowledged that the team’s view is a attention in order to reduce the interference of
limited perspective based on the available infor- competing agendas. An adverse event will
mation at the time of the investigation [41]. involve many potential problems that could
A meeting to debrief and discuss the team’s find- potentially consume large amounts of time and
ings with local staff across discipline and depart- resource. It is useful for debriefing sessions to
ment boundaries is the single most important look beyond the event and consider the patterns
step. In the example of the trauma case above, and trends from similar events within the context
there was significant email conversation between of the facility.
clinicians about drafting recommendations out- In the trauma case above, after the investiga-
side of the scheduled team meetings. The investi- tion was completed, members of the investiga-
gation reporting process became a vehicle for the tion team participated in an open interdepartmental
articulation of patterns and the identification of Trauma Meeting where people involved in the
potential solutions to the issues raised by the dis- adverse event and their clinical peers were able to
cussion of the case. Constructing the investiga- make sense of the investigation team’s findings
tion report provided the team with a medium for through the debriefing process. The debriefing
inter-professional dialogue and debate that did brought together in one room key people who
not previously exist in the perioperative culture were loosely connected with the case. If the
of the facility. larger feedback meeting had not been held, there
was a risk that opinion and rumor would impede
the impact of the investigation. The Trauma
Staff Debriefings Meeting proved an effective forum to produce
insight, synthesize bits of information, and con-
Translating investigation reports into meaningful ceptualize improvements in perioperative care
actions is a challenging task. In fact, in our 35 delivery. Intelligently, the trauma physician had
years of combined experience in being part of recognized that routine organizational networks
over 400 adverse event investigations, the inves- were not able to resolve the workplace tensions
tigation process is largely disconnected from related to the case due to the impact of a death in
everyday clinical practice and thus imposes a the operating room. A different mode of thinking
huge administrative burden on individuals who was required that would be a “springboard into
have ongoing operational responsibility as well action” for the local clinicians [14]. The coordi-
nated response to the case piqued the interest of The analysis conducted by the investigation
staff and helped to embed the Trauma Meeting as team usually consists of a combination of propo-
a respected clinical forum. Attention to how staff sitions about characteristics of the event based on
conceived the adverse event in the perioperative standardized language contained in checklists of
setting in retrospect was a key feature of the coor- human factors categories [9]. Interpretation is
dinated response to the case. drawn from what is knowable about the event and
Reflection on the outcomes of incident inves- the report should provide a reader with a clear
tigation requires careful handling and this applies picture of what was happening at the time of the
directly to the way the investigation report and its adverse event. The investigation team report goes
recommendations are disseminated and shared in beyond the experience of people involved in the
the local clinical environment. The report needs event and includes statements drawn from the
to be seen as part of an ongoing process of mak- collective knowledge of the team, use of elec-
ing sense of clinical work and not a fixed defini- tronic medical records about similar events in the
tive statement. Socializing the report (and the perioperative setting, as well as global experi-
ongoing place of the adverse event in the local ence with similar events. This is the process of
workplace culture) is a collective thinking task understanding at work. Investigation teams are
that requires a coordinated response, with due not able to present an objective interpretation, as
regard for differing standpoints, acknowledge- both authors and readers of an investigation
ment of hindsight biases, recognition of familiar report, bring with them subjective perspectives
cues, an emphasis on plausible explanation rather based on their own experiences and understand-
than root causes, and provision for people to ing of the clinical workplace [30]. However, if
adjust to the impact and changes that result from the characteristics of the event described in the
the investigation [6, 14]. report are not recognizable the readers are likely
to dismiss the report as unrepresentative of the
event as experienced or a simple white wash of
ow to Interpret an Investigation
H the events by management [43].
Report
The nature of an investigation report will depend What Is in a Name?

to a large extent on the selection of methods and
techniques for the investigation of an adverse It is appropriate to mention the role of the word
event and the leadership style of the person in “event” at this point in understanding the investi-
charge of the investigation [41]. Regardless of gation report process. A word like “event” is an
the particular method of inquiry chosen, the approximation of something that has happened in
investigation report should contain deductions the clinical setting for the purpose of making it
from the known facts about the event and a set of knowable [6, 18]. The adverse event described by
proposed recommendations or corrective actions the investigation team is not the same as the
that address the problematic situation surround- experience of that event by the people involved.
ing the adverse event in a particular time and While this may seem self-evident it is an impor-
place. It is important to note how the experience tant distinction about the process of interpreta-
and expertise of the investigation team is position. Clinical operations in the perioperative
tioned relative to the perioperative workplace. environment are a dynamic ongoing activity.
The stance adopted by the investigation team, its When an investigation report speaks of an event
demeanor and credibility, and the selection of it represents a moment in time when something
methods of inquiry directly shape the strength of changed [6]. An event does not come packaged
the statements made in the report and the range of as an organic whole. The beginning and end of
possible conclusions that readers of the report the event described in the investigation report
can make as they interpret the report. chronology is a convenience. Put simply, the
investigation team sets up the conditions for demands of external administrative control [44].
interpretation. If it is not made clear to the read- The investigation report is a vital part of the pro-
ers of the report that the event is an approxima- cess by which local staff in the perioperative suite
tion of what happened, the risk is run that people deal with the experiences and outcomes of an
will feel that what they personally know has been adverse event. A report needs to be written in an
left out of the picture or erroneously modified. accessible form in order for different readers to
The reporting process, therefore, is concerned find ways to discriminate what they know from
with making the adverse event knowable. There is the knowledge gathered by the investigation
considerable potential for the investigation report team. It may be helpful to consider three types of
to be interfered with by distracting factors and the report formats: a one page executive summary, a
final version may be altered due to the introduc- three page summary, and a more detailed report
tion of different perspectives to those captured by with all the key investigation findings. The report
the investigation team [41]. Unwittingly, clinical is not a final statement but a transition document
leaders, senior management and health facility that identifies the problems that require ongoing
administrators may impede the interpretation of attention in the perioperative setting. Report find-
the event due to their concerns about the wider ings are more likely to be made known when they
implications within the organization and beyond relate to how the perioperative workplace is
if and when the report is shared with external experienced.
stakeholders. The investigation report is not New knowledge about an event takes on
intended to cover all related clinical situations meaning when it is considered in the context of
and possibilities. The investigation team report the familiar circumstances and conditions in the
deals with a specific problematic situation in a local environment where problems are experi-
particular perioperative workplace setting such as enced and managed. Finding points of identifica-
an operating room at the time of the event. It is tion with the report will enable resolution of the
important to clarify that the investigation report issues raised by the adverse event. People with
must be understood within these parameters. local knowledge need to come together and talk
The testing of what is recommended in the often several times about the report in order to
investigation report will follow. It is important make progress beyond the approximations of the
that senior management can make decisions about investigation team. This is rather different from
what changes to implement based on a clear pic- essential explanations that reduce an adverse
ture of what was knowable from the event based event to an allocation of root causes. What moves
on the characteristics of what was happening at an event forward is when a cogent narrative is
the time of the adverse event [26]. The descrip- conceived in terms of a specific perioperative set-
tion of the event in the investigation report pro- ting where new knowledge about the operational
vides a structure or framework for interpretation problems can be differentiated from existing
by different audiences. The report needs to con- knowledge and corrective steps can be imple-
tain information that will enable readers to con- mented [41].
struct a meaningful picture of the event that
relates to the reality of everyday experience [14].
Care must be taken when reducing an event to ngaging Staff in Learning
E
essential or abstract terms in an investigation Through Feedback and Debriefing
report (e.g., human factors categories, incident
classification systems, and risk management con- Studies of investigation reports and the imple-
trols). The selection of investigation methods mentation of investigation team findings follow-
directly impacts the way a report is written and ing surgical adverse events commonly report that
interpreted [18]. The guiding principle when the team has “no power to enforce any recommen
reading a report should be determining local dation or ensure compliance” and that learning is
operational utility more than satisfying the limited to the clinical unit involved in the event
[45, 46]. Publishing aggregated RCA data may assessment in health care over the last decade
improve the dissemination of knowledge, but it [50]. Incident management systems and adverse
does not follow that this is an effective strategy to event investigations work hand-in-hand. How
engage staff in meaningful learning at the level of ever, despite improvements in reporting and data
the perioperative suite in individual facilities collection, progress with changes in the reliability
[47]. Despite a sustained response in the litera- of clinical operations as an outcome of adverse
ture to the category of “wrong surgery” and the event investigations has been less convincing in
implementation of checklists and time-out proto- the literature [51]. This is because reliability is a
cols by surgical teams, meta-analyses of RCA local dynamic property within clinical micro-
reports are limited to confirming that incorrect systems (i.e., in this case, the perioperative set-
surgeries continue to occur at a rate not much dis- ting) and not a stable property of the health
similar to before checklists were required [48]. system [52]. Tools and techniques that test the
Aggregating data from multiple RCA reports reliability of local clinical systems and the effi-
does not make the clinical workplace environ- cacy of local system design provide a useful
ment more predictable; rather it creates a false adjunct to incident investigation. Indeed, they
impression of an ordered world waiting for its may be integral to the testing and evaluation of
causal links to be identified [6]. The reality is that recommendations arising from adverse event
adverse events take place within a flow of investigation reports.
dynamic activity not isolated in discrete and
context-free repeatable actions. The meta-
analysis of wrong surgery events suggests that Applying Probabilistic Risk
“errors upstream and downstream” to the imple- Assessment (PRA)
mentation of universal checking protocols in the
perioperative suite require attention [48, 49]. The national and international professional stan-
However, what might be happening upstream in dards for the regulation of perioperative environ-
one perioperative setting may well be rather dif- ments provide a useful guide to the boundaries of
ferent to other surgical departments. Activity safe operation in the operation room. In contrast
downstream today in a given facility may be due to perioperative risk assessment with a clear
to rather contrary factors tomorrow. focus on the patient and procedural risk for dif-
The metaphor of the stream of activity is a ferent patient groups, PRA is concerned with
step in the right direction [6]. However, to effec- assessing and evaluating the safety of the operat-
tively engage staff in making sense of adverse ing room environment [53]. Adverse event inves-
events in the continuous flow of clinical experi- tigation identifies problems in the current system
ence, a strategy for workplace learning is required and regulatory standards indicate optimal operat-
that can be tailored to the dynamic conditions of ing room practices. In anesthesiology in particu-
local clinical culture [15]. This process is impor- lar there are checking procedures for multiple
tant for making sense of investigation team find- items of equipment and the related processes. It
ings in everyday operations [10, 11]. is routine to run safety drills and simulations to
identify how best to recover from conditions that
threaten patient safety in the operating room.
Building an Adaptive Workplace Individual investigations of adverse events
Culture include some level of commentary on the chro-
nology of actions, or sequence of events that
There are activities that can augment or even were precursors to the event. Identifying these
replace the need for an incident investigation by factors can help inform where redundancies need
focusing attention on the analysis of the clinical to be built into clinical practices to promote
workplace. Considerable attention has been surgical safety [54]. In the root cause analysis
given to near miss reporting and clinical risk methodology, for example, this is referred to as
barriers and controls. In order to determine which pplying Failure Modes and Effects
A
interventions are critical for perioperative safety, Analysis (FMEA)
a process such as probabilistic risk assessment
(PRA) can be applied to measure specific thresh- FMEA is a useful tool to analyze workflows
olds of safe operating practice within the bound- through the perioperative suite following an
aries of the relevant professional standards [45]. adverse event. An investigation may identify that
Considerable attention to safety in the surgical an aspect of operations within the perioperative
environment has identified a need to balance suite is not performing as intended. Investigation
effective utilization of perioperative resources teams can also use FMEA to develop and evalu-
and operating room time with strategies and tech- ate recommendations for corrective action in a
niques to reduce risk and promote patient safety. final report. The analysis of the failure modes and
An adverse event investigation can highlight effects involves identifying the elements and
areas needing attention in the current design of their sequence in the procedure under review, the
operational systems, the configuration of equip- conditions that could result in failure at each step,
ment, or the physical layout of the perioperative the effects of each failure on the performance of
space. In determining priorities, a PRA will pro- the procedure, the likelihood that the failure
vide an estimation (based on current operations) could occur under local conditions, the impact of
of the safety measures that reduce the frequency the failure on patient safety, and, what remedial
and likelihood of future adverse events at differ- action could reduce the risk of failure [27, 57].
ent levels of utilization for the particular opera- Measurable activities in the perioperative set-
tion, operating room and the dedicated surgical ting include standardized processes with multiple
procedures within a perioperative facility. steps performed in sequence. As an adjunct to an
The limitation of PRA is that it is less able to adverse event investigation it useful to break a
predict future risks that may produce unexpected procedure or protocol into separate steps using a
events and the uncertainties that a change in pro- process mapping methodology, and consider the
cedures may introduce [55]. Maintaining real stages where something unexpected happened or
time activity within the perioperative setting there is potential for the sequence to break down.
within the boundaries of safe practice is mostly Rather than look at the prevailing conditions in
dependent on clinician expertise and experience the perioperative suite, the FMEA looks specifi-
in observation and interpretation of the available cally at human interaction with technology or
information on a given day. Local adverse event equipment and the potential for procedural fail-
data, however, can be used to inform ongoing ure at a systems level [27].
risk assessment. PRA when used in combination An example of an adverse event where the
with and adverse event investigation report pro- consequences of a procedural failure needed to
vides information about problem identification be mapped out involved a patient who had a spi-
and resolution within the boundaries of safe nal fusion performed at the incorrect level [58].
operation [24]. Clinicians and managers must The local neurosurgical practice for sighting and
make the decisions about how the investment in marking of spinal levels was a contributing factor
resources, changes to operating room schedules, to the adverse event. FMEA identified that the
and introduction of new procedures will impact timing of access to radiological images was criti-
current levels of system safety in the periopera- cal as was the ability of the members of the surgi-
tive suite. One method available to determine the cal team to visualize and confirm the spinal level
duration of a cases or how changes already under with the radiology team. A key finding was that
way might impact current safety is through the position of the surgeon relative to the patient
Bayesian analysis. Bayesian analysis refers to the and the position of the assisting surgeon on the
use of previous observations and current infor- opposite side of the operating table could give the
mation to help determine future events [56]. perception of different spinal levels depending
on the viewing angle. Visualization of the radio- perioperative settings). The retrospectively con-
logical image was not always completed at the structed chronology of an adverse event needs to
same time by each surgeon due to movement make sense in terms of everyday operations, as
within the operating room relative to the position they are currently experienced, not at some imag-
of the viewing box. In the adverse event, this was ined point in the past. When it comes to interpre-
compounded by the fact that the two surgeons did tation, it is important to acknowledge that all
not provide clear verbal confirmation to each arguments about adverse events cannot be sepa-
other or to others on the team in the room about rated from the current experience of the clinicians
the spinal level. An experienced neurosurgeon doing the interpreting. The determination of the
not involved in the adverse event used the infor- beginning and end of an adverse event is con-
mation available to the investigation team to ana- structed through the process of an adverse event
lyze the practice for spinal marking at the facility investigation, as it is easier for the investigation
and developed specific insights to reduce the team to deal with a finite bounded set of circum-
chances of similar events. The high probability of stances. How an event is then put back into
recurrence suggested by the FMEA led to a the continuous flow of perioperative activity
change in the local procedure whereby both sur- is a separate but crucial task to the actual
geons had to provide clear verbal confirmation investigation [6].
citing specific anatomical markers and read-back An adverse event is but one moment in the
their interpretation of the radiology image to the continuous flow of activity in the perioperative
entire OR team. The agreed position was recorded setting. This flow of action is essentially local,
by a third person prior to the marking of the spi- making it necessary that the event be examined
nal level for the surgery. Before the investigation, and interpreted via a range of thinking processes
the neurosurgeons at the facility had varying that enable the construction of a composite pic-
individual practice for sighting and marking spi- ture that can be translated by local clinicians and
nal levels. The FMEA provided an opportunity to managers into everyday operations where there
develop a consistent and reliable practice. are ongoing interrelated problems in motion that
relate to and continue to inform the interpretation
of the adverse event and the resolution of prob-
ooking Beyond the Investigation
L lems raised at different levels of operations
Phase within the perioperative clinical micro-system
[7]. The various processes recommended that
Following the incident investigation there is the might help to manage what might be distorted or
interpretation phase. Different groups will inter- limited in defining and discussing the event from
pret the findings of an investigation team, and the particular preferred perspectives of dominant
therefore, there is a need to create opportunities clinicians in the clinical workplace culture.
for making sense of the event back in the clinical
setting of the perioperative workplace [6, 14].
Adverse events have a context around which var- ranslate Insights into Everyday
T
ious arguments are constructed and perceptions Operations
are shaped by different groups of people. The dis-
cussion of a particular event must become sensitive Translating knowledge involves more than the
to operations in the local clinical setting, taking formal feedback of the findings by the investiga-
into account the impact of the relative distance of tion team in the form of a report. What is involved,
the event in time and space. The treatment of in knowing even what the investigation team dis-
individual adverse events in terms of how they covered, is more than what is now known about
are experienced by different groups facilitates the adverse event, there is also the knowledge that
discrimination of what is relevant from a range of each discipline and practitioners of differing lev-
possible explanations (that might apply to other els of expertise seek and how various people
make sense of the event according to their ctively Explore the Problematic

A
particular set of relations within the perioperative Situation with the People Involved
setting [25]. It is important to acknowledge who
wants to know about an adverse event, how it has Formal feedback following an adverse event
impacted different people psychologically, and investigation is often limited to summary state-
what variations on the story have accumulated in ments of the investigative team’s findings and rec-
the workplace about the event. Translation, in ommendations. This is not adequate for frontline
contrast to unilateral forms of feedback f ollowing clinicians and risks undermining the credibility of
an adverse event, seeks to integrate and take into the investigative team on this and future
consideration these various perspectives [25]. investigations. The outcome of the team’s event
The everyday operations at the local periopera- analysis and the proposed solutions to the original
tive workplace are the basic setting for trans problematic situation need to make sense in rela-
lating event analysis into different levels of tion to what is already known about the periopera-
organizational knowledge. It is the place where tive setting, for the different groups of people who
the explanation for an adverse event is grounded want to know about the adverse event, incorporat-
and the process of sense making is translated into ing the current state of knowledge about the vari-
genuine insights. ety of actions and human factors the investigation
This does not mean that inquiry is reduced to team identified as pertinent to the adverse event
the level of opinion. Rather, in selecting appro- under review (outlined in Table 41.4).
priate methods, the subjective is viewed as guid- Safe practice and adverse events exist on a
ing the human factors analysis. The selection of continuum and learning comes from seeing the
an appropriate means whereby an investigation tension between interruptions to normal periop-
team’s findings can be translated into the erative activity and routine activity in the same
functioning of the local workplace should be
organizational space [18]. In order to extract the
supplied. The process of translation involves
most value from the investigation of an adverse
activities such as simulating and testing knowl- event the local managers and clinicians need to
edge and skills, analyzing the components of a step back and look at the event in the wider con-
task, reviewing communication channels, and text of the continuous flow of perioperative activ-
evaluating resource constraints and utilization [25]. ity while constantly evaluating the impact of the
Suitable methods for the translation of the inves- proposed policy or service interventions [61].
tigation team findings include but are not limited
to process mapping [7], common cause analysis
[59], implementation mapping [60], probabilistic est Alternative Actions
T
risk assessment (PRA) and failure modes effect and Hypotheses
analysis (FMEA) as discussed previously. These in the Perioperative Setting
devices need not be applied in isolation from
everyday activity, but facilitate ongoing discus- How do the various recommendations made by
sion and meaning construction. The analysis of the investigation team fit together? The dynamic
any adverse event should not be viewed in isola- nature of activity in the perioperative setting
tion from the particular nuances of the workplace needs to be taken into consideration when evalu-
environment and the people who do the periop- ating the applicability of the investigation team’s
erative work. The findings of the investigation recommendations. The formalized standard lan-
team are basic working hypotheses or approxi- guage of investigation techniques such as RCA
mations that require testing in real situations (e.g., mitigating actions and quantifiable outcome
where they can be made meaningful to the people measures) can give an impression that the recom-
who use the workplace. mended actions that result from the investigation
Table 41.4 The problems that investigation teams identify bring the (human) factors related to different types of
knowledge together around a variety of human actions
Types of knowledge Variety of human actions
The experiences of What is pertinent to the perioperative setting that was not evident prior to the
individual people involved interpretation of the adverse event? And conversely, what aspects of the event are
in the adverse event relevant to prior experience in the local workplace? What do people pay attention to
and what do they ignore?
The habits and routines of In some accident models these problems are referred to as “latent” or “system” level
the organization issues. Activity in the clinical workplace is determined by local systems as defined
by the particular perspectives of people working at the time
User perspectives on Techniques such as PRA and FMEA can assist in identifying local definitions and
technology and work perceptions of human–machine interfaces in particular situations and practices.
Simulation and thinking aloud can be very useful here in stepping through the use of
technology by the people involved in the event, and any proposed changes to the
application of technology following the investigation
The varying bodies of A clinical workplace problem concerns not only interdisciplinary and
knowledge among the intradisciplinary communication about clinical work but the beliefs and practices at
clinical disciplines different levels of expertise within each clinical discipline
are stable and reliable and ready to be imple- respected. Knowing how normal work is done
mented [9]. This could not be further from the will make the interventions of the investigation
truth. The recommendations presented in an team less arbitrary and more trustworthy.
investigation team report are vulnerable to many
distortions and intrusions and as such require
careful interpretation before being considered for evelop Effective Strategies
D
implementation [41]. It is well reported that rec- for Insight into Local Systems
ommendations from RCA investigations have an
uneven record of effective implementation [5, The investigation team’s stable recommendations
46, 62, 63]. This may in part be due to a lack of need to be distinguished from the ambiguity of
processes to test the viability and feasibility of everyday operations in the perioperative setting.
proposed changes to action in the clinical The distinction involves identifying the differing
workplace. The different groups that constitute frames of reference that are an integral part of
the perioperative workforce have varied levels working relations and the arguments people
and awareness of knowing about surgical work express in support of certain recommendations
and its processes, and differing experiences of over other changes proposed by the investigation
working in the perioperative setting (e.g., the per- team. There is no objective stance apart from the
spective of the surgeon will vary to that of the world of experience. Experiences bring together
circulating nurse on the team in the same operat- those who want to know and what is known about
ing theater on a given day). an adverse event. The insights that are produced
The recommendations made in the investiga- as a result of an investigation process make sense
tion report need to be tested with surgical teams to people as the new knowledge enters into circu-
at different levels engaged in everyday work- lation within the workplace [25].
place activity, or simulations of that activity Statements about zero tolerance for error in
where real time testing would either be unethical health care and preventing harm are at best wishful
or not feasible [37]. The perspectives of all peri- thinking and at worst create cynicism, anger, dis-
operative team members on the surgical pro- trust and contribute to clinician burnout (Compare
cesses are needed in order to facilitate practical [29] with [64]). Turning error management into a
testing. Well-designed team based simulations bureaucratic activity stifles local attempts to take
enable the necessary actions that underpin any risks and develop insights [16]. For example, it is
surgical situation to be better understood and common to label the causes of adverse events as
quality and safety activities (e.g., retrospective

investigations that produce hypothetical recom-
mendations to reduce errors) and looking at what
people actually do to recover from a breakdown
in care delivery (by strengthening informal oppor-
tunities for local conversations about p erioperative
team experiences using qualitative methods such
as interviews, focus groups, observations and
more) [68]. Both systems are necessary but they
require different approaches, in order to continue
general strategies that reduce errors and to also
Fig. 41.2 The desire to pursue system stability is com- develop strategies that enable local system
pelling in health care organizations (arrow #1). What can insights to be brought to light [3]. These systems
be known about the perioperative suite exists on a contin- help to create resilience that allows people to con-
uum between stable predictions about the system on the duct hundreds of operations a week with few to no
left and significant breakdowns in the system on the right
adverse events.
The evaluations of incident investigation pro-
“communication failure,” but this practice simply
cesses such as RCA consistently identify that
generates another cycle of event classification
health care organizations need to prioritize time
rather than exploring the systemic vulnerabilities
and offer some productivity slack for clinicians
in the local clinical context [19, 65]. Likewise, and
and managers to reflect on their learning, share
importantly for the present discussion, adverse
information and insights about everyday care
event investigations are a quality and safety activ-
delivery problems [5, 31, 46, 63]. Existing review
ity and a product of system stability that often con-
meetings within the perioperative workplace
stitute the immediate response to system failures
environment could profitably be redesigned to
(Fig. 41.2). In contrast to the stable activities pro-
meet regularly to explore and discuss the lessons
duced by the left hand side of the diagram, rich
learned and patterns identified from incident
information about perioperative communication
investigations. A single incident investigation is
pathways generated through everyday clinical
simply not adequate to capture the insights that a
work provides an opportunity for robust local dis-
complex problematic situation entails. Shifting
cussion and interpretation (middle column of the
the emphasis from stable system processes to
diagram). Real insight comes from exploring
thinking about the ambiguous and unexpected
ambiguous and novel situations (arrow #2).
opens the team up to a variety of responses and
Unlocking system insight involves building a local
sets up the conditions for mindfulness in the local
workplace culture for learning from experiences in
perioperative workplace culture [15].
a supportive environment where clinicians and
managers feel safe to experiment with new ways
of doing things [3, 15, 66]. Developing system References
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Multi-institutional Learning
and Collaboration to Improve 42
Quality and Safety
Julie K. Johnson, Christina A. Minami,
Allison R. Dahlke, and Karl Y. Bilimoria
“If you want to go fast, go alone. If you want to go far, go together.”

—African Proverb
Introduction waiting times, and improved management of peo-

ple with chronic illness [3]. Along with reports of
A quality improvement collaborative (QIC) is a measurable success, several authors question
broad-based approach to identifying and adopting whether the QIC model is an effective mechanism
best practices and implementing rapid organiza- for improving patient care [4]. Others argue that
tional change [1, 2]. The term is now commonly the methods of evaluation are lacking and have
used to describe different multifaceted interven- failed to capture the unique complexity of improv-
tions that focus on accelerating better outcomes for ing care in complex organizational settings [5].
a targeted topic [2] and, while focused in a number This chapter outlines the history of quality
of areas, are understood to use similar methods for improvement collaboratives and describes the
clinician engagement as well as a relentless focus role of the collaborative model in improving sur-
on continuous quality improvement. gical quality of care. We discuss core structural
Clinical outcomes attributed to QICs include components of a collaborative and research iden-
reduced inpatient mortality rates associated with tifying key success factors. Finally we consider
coronary artery bypass graft procedures, decreased the challenges in evaluating the effectiveness of a
neonatal infection rates, decreased C-section collaborative. Research on teamwork, leadership,
rates, less costly prescription practices, improved and communities of practice can inform the
patient safety, decreased emergency department development of future collaboratives.
J.K. Johnson, MSPH, PhD (*)

Department of Surgery, Center for Healthcare Studies, istory of the Quality Improvement
H
Institute for Public Health and Medicine, Feinberg Collaborative
School of Medicine, Northwestern University,
633 North St Clair, Chicago, IL 60611, USA
A quality improvement collaborative is simply
defined as multidisciplinary teams from various
C.A. Minami, MD, MS • A.R. Dahlke, MPH
health care departments or organizations that join
K.Y. Bilimoria, MD, MS
Department of Surgery, Surgical Outcomes and forces for a period of time to work in an agreed
Quality Improvement Center, Feinberg School of upon structured way to improve care or a defined
Medicine, Northwestern University, population of patients [4, 6]. In essence a quality
633 N. St. Clair Street, 20th Floor,
improvement collaborative acts as a “temporary
Chicago, IL 60611, USA
e-mail: [email protected]; learning organization” [7] with the goal of shar-
[email protected]; [email protected] ing and spreading of ideas.

716 J.K. Johnson et al.
In his work on social learning systems, Wenger munity of practice which are relevant for QIC:
recognized the potential power of “communities (1) design for evolution, (2) open a dialogue
of practice” within and across organizations that between inside and outside perspectives, (3)
resulted in not only the sharing of information but invite different levels of participation, (4) develop
also the generation of information through their both public and private community spaces, (5)
interactions. A community of practice is “a group focus on value, (6) combine familiarity and
of people who share a concern, a set of problems excitement, and (7) create a rhythm for the com-
or a passion about a particular topic, and who munity [8].
deepen their understanding and knowledge of this Thus, a QIC is a community of practice.
area by interacting on an ongoing basis.” [8]. Introduced initially in the USA in the mid-1980s,
Communities of practice are characterized by the QICs are now used in many countries with varying
domain (an identity defined by shared interest, health care financing systems, including Canada,
commitment, and shared competence), the com- Australia, and European countries, where several
munity (joint activities and discussions to help national health authorities support nationwide
members of the community and to share informa- quality improvement programs based on this strat-
tion), and the practice (the shared repertoire of egy. A similar approach has been used in the UK
resources, experiences, stories, and tools). The through its National Health Service Modernization
combination of these three elements, as well as Agency; it is call the Beacon Model and focuses on
the development of these elements in parallel, transfer of best practices, derived from Beacon
creates the community of practice. organizations “that have achieved a high standard
According to Wenger and colleagues, a com- of service delivery and are regarded as centers of
munity of practice can be distinguished from for- best practice” [6].
mal departments and project teams along the The earliest well-documented QICs are those
following five dimensions [8]: of the Northern New England Cardiovascular
Disease Study Group, established in 1986, and
1. Purpose: to create, expand, and exchange knowl- the Vermont Oxford Network, established in
edge, and to develop individual capabilities; 1988. Another well-known approach is the
2. Membership: self-selection based on exper- Breakthrough Series developed by the Institute of
tise or passion for the topic; Healthcare Improvement in 1995 [10].
3. Boundaries: Communities of practice have
Participants share a commitment to making
fuzzy boundaries (in contrast to a business or small, rapid tests of change that can be expanded
organization with distinct boundaries); to produce breakthrough results in a specific clin-
4. What holds them together: passion, commit- ical or operational area [11]. There is evidence of
ment, and identification with the group and its effectiveness in improving targeted topics [10]
expertise; and, together with evidence of positive spill-over
5. Life cycle: communities of practice evolve effects on participating teams in other areas of
and end organically; they last as long as there care and enthusiasm for improvement [12, 13].
is relevance to the topic and interest in learn-
ing together.
I mproving Surgical Quality
A community of practice is an umbrella term via the Collaborative Model
for a number of different organizational group-
ings that are characterized by the support for for- QICs have become particularly prevalent in sur-
mal and informal interaction between novices gical care, especially at the state-level [14–17].
and experts, the emphasis on learning and shar- Michigan Perioperative Transformation
ing knowledge, and the investment to foster a Network, Tennessee Surgical Quality Collaborative,
sense of belonging among members [9]. Wenger Washington State’s Surgical Care and Outcomes
suggests seven principles for cultivating a com- Assessment Program, and the Illinois Surgical
42 Multi-institutional Learning and Collaboration to Improve Quality and Safety 717
Quality Improvement Collaborative are described data to do surgeon specific reporting. A central
in the following paragraphs. website, managed by the Tennessee Center for
The Michigan Perioperative Transformation Patient Safety, allows data to be shared between
Network (MPTN) is unique in that it is a collec- all participating hospitals. In turn, lessons in
tion of collaboratives. It includes the Michigan applying this data to quality improvement
Surgical Quality Collaborative (MSQC), which efforts are shared at in- person meetings.
focuses on improving surgical quality, the Because the Tennessee ACS chapter was heav-
Anesthesiology Performance Improvement and ily involved in the initiation of the collabora-
Reporting Exchange (ASPIRE), which incorpo- tive, there was a preexisting camaraderie
rates anesthesiology to improve perioperative between the participating surgeons that facili-
care as a whole, and the Michigan Value tated open discussions regarding surgical qual-
Collaborative, which seeks to optimize the cost- ity early in the collaborative. Since the inception
efficiency of surgical episodes. As one of the of the collaborative, post-operative complica-
“value partnerships” that Blue Cross Blue Shield tion rates have markedly declined throughout
of Michigan created with physicians, organiza- participating hospitals: postoperative acute
tions, and hospitals in order to accelerate quality renal failure has been reduced by 25 % and sur-
improvement, MSQC was one of the first surgical gical site infection by 19 % [18].
quality collaboratives in the nation and exempli- Washington state’s Surgical Care and
fies a successful partnership between payer and Outcomes Program (SCOAP) was started in 2005
hospitals. MPTN emphasizes (1) culture change, after significant variability in surgical outcomes
(2) data sharing, and (3) best practice implemen- were noted by the University of Washington’s
tation. Culture change is addressed at quarterly Surgical Outcomes Research Center. Funded in
meetings, where performance, data assessment, part by a grant from Washington state’s Life
and implementation of best practices are dis- Science Discover Fund, SCOAP is also sup-
cussed. Data sharing not only includes a focus on ported by hospital-paid subscription fees. With
driving change guided by hospital-specific 50 participating hospitals, SCOAP is a large
reports, but also includes sharing information state-collaborative that has, like Tennessee, lever-
regarding collaborative learning and details spe- aged the state chapter of the ACS to enhance par-
cific to hospitals’ areas of exceptional perfor- ticipation and support. SCOAP generates
mance. Best practices are identified from quarterly risk-adjusted hospital-specific data and
high-performing hospitals from the collaborative creates a community that shares best practices in
registry and shared after being modified for local a transparent fashion. This collaborative has
contexts. For instance, one hospital that had notably achieved broad adoption of collaborative-
markedly low blood transfusion rates, shared wide instruments; a modified surgical checklist,
their protocol, which was then modified and which included process metrics on which
adopted by the network hospitals. This resulted Washington was underperforming (e.g., glyce-
in a collaborative-wide 22 % drop in periopera- mic control in diabetic patients), and a checklist
tive transfusions [18]. initiative to reduce preoperative risk (known as
The Tennessee Surgical Quality Collaborative Strong for Surgery), have been successfully
(TSQC) was established in 2008 and, similar to deployed in recent years [18].
MSQC, was born of a partnership between Blue The newcomer to the field of surgical collab-
Cross Blue Shield of Tennessee and local hospi- oratives is The Illinois Surgical Quality
tals. In addition, the collaborative was supported Improvement Collaborative (ISQIC) which was
by the Tennessee chapter of the American developed in late 2014. ISQIC is a payer-funded
College of Surgeons (ACS) and the Tennessee initiative and includes 57 diverse Illinois hospi-
Hospital Association. The Tennessee collabora- tals that agreed to adopt the widely recognized
tive emphasizes data-driven change and TSQC American College of Surgeon’s National Surgical
was the first known collaborative to use their Quality Improvement Program (ACS NSQIP) as
the common data sharing platform. In addition, he Nuts and Bolts of a Quality

T
ISQIC includes 21 components to facilitate qual- Improvement Collaborative
ity improvement that target the hospital, the sur-
gical QI team, and the perioperative microsystem. The common characteristics of QI Collaboratives
The components were developed from available have been well described [2, 10] and emphasize
evidence, a detailed needs assessment of the hos- collaborative learning, support, and exchange of
pitals, reviewing experiences from prior surgical insights among different health care organizations
and nonsurgical QICs, and interviews with qual- [11]. Ayers and colleagues identified guidelines
ity improvement (QI) experts. The components for developing a successful learning collabora-
comprise five domains: guided implementation tive, based on qualitative interviews with key
(e.g., mentors, coaches, statewide QI projects), informants from ten established learning collab-
education (e.g., process improvement curricu- oratives [1]. Table 42.1 outlines their findings
lum), hospital- and surgeon-level comparative which could be used as structural guidelines for
performance reports (e.g., process, outcomes, developing a successful learning collaborative.
costs), networking (e.g., forums to share QI expe- In the simplest terms, the ultimate goal of a
riences and best practices), and funding (e.g., for collaborative is learning. Beyond the structural
the overall program, pilot grants, and bonus pay- components outlined in Table 42.1, Gauthier
ments for improvement) [19–22]. [24] suggests several conditions for successful
Figure 42.1 illustrates the conceptual model collaborative learning across organizational
that we developed to guide the implementation boundaries:
and evaluation of ISQIC. The overarching influ-
ence of the collaborative (purple) is depicted as • Participants should have similar maturity level
operating on the Hospital, Surgical QI Team, on the learning continuum (e.g., with some
and Perioperative Microsystem levels of surgi- experience of quality improvement techniques
cal QI [23]. and vision building);
Fig. 42.1 ISQIC conceptual model

• Senior executives and line managers need to work together over a number of months to share
commit to a multiyear program and to involve ideas and knowledge. They set specific goals and
themselves personally in the learning sessions; measure progress toward meeting those goals.
• Participants agree to a noncompetitive envi- Through facilitated sessions, participants share
ronment to create a safe setting for sharing all techniques for creating organizational change
relevant experiences; and implementing rapid-cycle, iterative tests of
• A core team of facilitators combining general change at the microsystem level [6, 26].
and specialized skills should be involved in The functioning of a QIC can be tied to an
and between the meetings to help structure a effective team structure and strong leadership.
cumulative learning experience and increas- For example, in describing the successful appli-
ingly involve the participants in designing and cation of a QIC using the IHI Breakthrough series
co-leading the sessions; in 40 US hospitals to reduce adverse drug events
• There must be a willingness to experiment in Leape et al. (2000) identified strong leadership
content and format from session to session, and and team work among their most important suc-
a commitment to dialogue and collaboration; cess factors: “Success in making significant
• Participants should be encouraged to take time changes was associated with strong leadership,
for exchanges between the learning sessions effective processes and appropriate choice of
(social networking, site visits, etc.) intervention. Successful teams were able to
• A focus on personal development and on chal- define, clearly state and relentlessly pursue their
lenging one’s mental models should be aims, and then chose practical interventions and
adopted from the beginning and sustained moved early into changing a process” [27]. As
throughout the multiyear program. the leader of the collaborative team, the Champion
has a unique role in the QIC. Champions persis-
Similarly, [25] describes four general catego- tently support new ideas; and have persistence to
ries of collaborative success factors: topics cho- fight both resistance and/or indifference to pro-
sen for improvement, participant and team mote the acceptance of a new idea or to achieve
characteristics, skills of facilitator and expert project goals [6]. A different type of leader—the
advisors, and ensuring ways to maximize spread boundary spanner—have influence across orga-
of ideas. Greenhalgh et al. elaborate that these nizational and other boundaries, acting as bridges
success factors result from: to connect people and ideas [6, 28].
1. Clearly focused important topics that address

clear gaps between current and best practice. Evaluation
2. Highly motivated participants who clearly

understand individual and corporate goals in a Intuitively, the collaborative model seems to be
supportive organizational culture. an effective way to learn and engage front line
3. Effective teams and team leadership whose goals clinicians in designing and implementing change.
are in alignment with those of the organization. What’s the catch? Mainly, creating and running a
4. Facilitation by credible expert, who provide collaborative is expensive and difficult to mea-
adequate support outside as well as through sure using traditional epidemiological methods.
the learning events. Mittman and others note that QICs are arguably
5. Maximizing the spread of ideas through net- the most important response yet to the health
working between teams and other mecha- “quality chasm,” and call for rigorous mixed-
nisms ([6], p. 167). method evaluation to identify factors which
determine their success [29].
Once the collaborative is established, there is The evaluation of QI collaboratives poses sub-
a general process of that guides the flow of stantial challenges given the multitude of changes
collaborative work in which participants agree to occurring simultaneously and the existence of
Table 42.1 Key components of a successful learning collaborative

Component Description
Mission and Clear and achievable mission
target Tangible goals
population
Membership Strategies for membership (application, invitation, etc.)
Defined roles • Clinical Leader or “Champion” (e.g., knowledgeable of improvement processes, ability to
integrate spirit of collaborative learning with everyday practice, willingness to share)
• Project Manager (e.g., coordinates communication, organizes and facilitates meetings,
project expertise)
• Data Analyst (e.g., transforms data into useful information)
Technology Develop data management and communication systems across member organizations to enable
collection, aggregation, and analysis of the data
Funding Identify and select sources (e.g., membership dues, private organizations, research institutions)
Governance Establish multidisciplinary decision-making body to guide Collaborative process
Contractual Establish and articulate policies addressing confidentiality, data ownership by organization
issues submitting data, publication/presentation process and rights, and participant responsibilities
Meetings Convene regular, formal face-to-face meetings
Modified from Ayers LR, Beyea SC, Godfrey MM, Harper DC, Nelson EC, Batalden PB. Quality improvement learning
collaboratives. Qual Manag Health Care. 2005;14:234–47
concurrent external and internal stimuli to pleted) which influence implementation effec-
improve care [30]. Further knowledge of the basic tiveness and interact in complex ways [32].
components of effectiveness, cost effectiveness,
and success factors is crucial to determine the
value of quality improvement collaboratives [10]. Conclusion
Comprehensive evaluation of a QIC requires
using mixing qualitative and quantitative data Working across institutions to improve quality
and methods to gain insight into the specific pro- and safety will be an important strategy for the
cesses and mechanisms by which the QIC future as we continue to improve quality of
method and its individual components operate patient care at the front lines as well as at the sys-
and to gain insights into the situational factors tem level. An effective collaborative requires
that facilitate or impede its acceptance, imple- acceptance of shared goals among all stakehold-
mentation, and effects including what service ers, measurement of processes and outcomes,
interventions end points to choose [29, 31]. The and sharing of best practices. The success and
Consolidated Framework for Implementation widespread adoption of the collaborative meth-
Research (CFIR) offers one potential method for odology is directly related to the growing trust in
evaluating a QIC [32]. CFIR was recommended transparent data sharing among like-minded
by the 2014 NIH-sponsored Conference on the health care professionals. This trust leads to
Science of Dissemination and Implementation meaningful exchanges and insights among
[33] and addresses the question of “Under what experts and peers who then apply best practices
conditions does the intervention work?” [34] to improve their care.
CFIR, validated in 51 studies, is a meta-theoreti-
cal framework comprising 19 other theories and
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Lessons Learned from Anesthesia
Registries About Surgical Safety 43
and Reliability
Richard P. Dutton
“A point of view can be a dangerous luxury when substituted for insight and
understanding”
—Marshall McLuhan, Canadian Communications Professor
data and broad rather than focused patient and

Introduction case populations. This history leads to different
strengths and weaknesses when compared to sur-
The Information Age has created the opportunity gical registries organized around narrow popula-
for new advances in surgical quality improve- tions, something that is explored below in detail.
ment, based on the ability to aggregate large Finally, the chapter prognosticates on the future
quantities of clinical and administrative data. of anesthesia registries, the potential for interac-
Anesthesiology, with a long history of self- tion with surgical registries and learning plaforms
inquiry to promote quality, has embraced the and what will become possible with the continued
development of multi-institutional registries. development of information technology.
Participation in these efforts enables anesthesi-
ologists to improve business efficiency, meet fed-
eral regulatory requirements, benchmark local The Regulatory Environment
outcomes to national norms, and conduct obser-
vational and comparative effectiveness research Since the 1999 publication of To Err is Human
spanning millions of anesthetics. by the Institute of Medicine, there has been
This chapter reviews the development of anes- increasing public scrutiny about the quality of
thesia registries over the past three decades, health care [1]. Federal programs have increas-
focusing on the accelerated growth of recent ingly focused on “pay for performance” as an
years, and describe the data captured, the feed- incentive to measure outcomes and continuously
back provided and the lessons learned. Use of reg- improve. The Physician Quality Reporting
istry data to meet “pay for performance” System (PQRS) was launched by the US govern-
requirements is described, along with the scien- ment as an incentive program in 2005 [2].
tific potential of registries in the years to come. Providers billing Medicare could report addi-
Anesthesia registries have evolved differently tional codes for eligible cases, demonstrating
from other registries in perioperative care, empha- compliance with evidence-based best practices.
sizing automatic rather than manual collection of In the early years, good performers were
rewarded with additional payment on their
Medicare claims; today, any physician not suc-
R.P. Dutton, MD, MBA (*)
cessfully reporting on at least nine measures is
US Anesthesia Partners, 12222 Merit Drive, Dallas,
TX 75225, USA penalized −2 % on future Medicare payments.
e-mail: [email protected] The physician’s practice group will be penalized

724 R.P. Dutton
an additional −4 % under the Value Modifier sys- going away but will likely increase signifi-
tem if fewer than half of the group are successful cantly given growing awareness to the escalat-
in PQRS. The Merit-based Incentive Payment ing costs and continued evidence of variable
System (MIPS) authorized by the Medicare value and patient harm. [4, 5] This is a major
Access and CHIP Reauthorization Act (MACRA) driver for registry development in anesthesia—
of 2015 replaces PQRS in 2019 with penalties as it has been in other domains of health care.
ranging up to 10 % of all Medicare income for Recognizing this, quality improvement profes-
low-performing groups [3]. Rather than continu- sionals not only embrace the collection and
ing to reward volume of services regardless of aggregation of data, but work behind the scenes
the quality of care delivered, the goal of the to make regulatory requirements for reporting
Department of Health and Human Services is to complimentary to the data desired for practice
increase the proportion of Medicare value-based improvement and scientific advance. The
purchasing from 30 % by the end of 2016 to 50 % American Society of Anesthesiologists (ASA)
by the end of 2018. has successfully advocated for development of
The evolution of the regulatory environ- the Qualified Clinical Data Registry (QCDR)
ment has been rapid enough that few physi- mechanism for group reporting of PQRS and
cians or health care administrators have a clear specialty-specific measures, with the intention
understanding of the rules and implications. of advancing multiple safety, value and aca-
Table 43.1 shows the changes in pay for perfor- demic agendas under the same umbrella [6].
mance systems over the past few years, with a Table 43.2 lists the currently approved PQRS
projection into the future. One safe assumption and non-PQRS measures for anesthesiologists
is the necessity to gather and report data is not under this system.
Table 43.2 PQRS and non-PQRS Measures supported

Table 43.1 Evolution of American federal Pay for
by the National Anesthesia Clinical Outcomes Registry
Performance programs affecting anesthesiologists
(NACOR)
1999 Publication of To Err is Human by the
PQRS measures Non-PQRS measures
Institute of Medicine
2005 Medicare Physician Group Practice incentive Beta-blockers for cardiac Transfer of care
program launched as a 3-year demonstration surgery patients checklist: OR to ICU
project Use of a bundle of sterile Prevention of
2006 Physician Quality Reporting System (PQRS) techniques for central postoperative nausea
launches, providing incentives to those venous catheterization and vomiting (adult)
reporting on quality events Assessment of pain in Prevention of
2008 Medicare eliminates hospital payments for osteoarthritis patients postoperative nausea
care resulting from “never events” and vomiting (pediatric)
2011 Affordable Care Act modifies PQRS, and Medication reconciliation Transfer of care
calls for transition from incentives to checklist: OR to PACU
penalties Pain assessment and Composite anesthesia
2013 Value Modifier system phase-in begins; follow-up safety
applied to groups of providers Perioperative temperature Perioperative cardiac
2014 Medicare endorses the first Qualified Clinical management arrest rate
Data Registries Tobacco cessation Perioperative mortality
2015 PQRS incentives all replaced by penalties; counseling
PQRS antibiotic measure retired; anesthesia Pain management in PACU reintubation rate
practice participation in QCDRs begins; first palliative care
announcement of Merit-based Incentive Patient-centered surgical Postoperative pain
Payment System to take effect in 2019 risk communication management
2016 Most claims-based reporting mechanisms for Central line placement
anesthesia quality eliminated in favor of safety
registry-based reporting (continued)
43 Lessons Learned from Anesthesia Registries About Surgical Safety and Reliability 725
Table 43.2 (continued) recording and comparing the details of care [7].

PQRS measures Non-PQRS measures In the 1930s pioneering anesthesiologist Emery
Measurement of patient Rovenstine recorded each of his cases on a
experience punch card, for tabulation by the precursor of a
Timely administration modern computer [8]. Beecher and Todd in 1954
of antibiotics
published a landmark paper on surgical out-
New perioperative
comes calling out the risks of anesthesia, based
temperature
management on the aggregation of case records from a con-
Aspirin for patients with sortium of university hospitals [9]. The earliest
cardiac stents automated record keeping systems were devel-
Use of a surgical safety oped in the 1970s, but the real acceleration of
checklist these efforts began in about 1990 with wide-
Smoking abstinence spread deployment of microprocessors. This
before surgery
coincided with a series of breakthroughs in mon-
Perioperative corneal
injury itoring, leading to the present day capture in
Timely extubation after electronic anesthesia records of simultaneous
cardiac surgery output from more than a dozen different mea-
Stroke after cardiac sures of patient status, including heart rate and
surgery rhythm, blood pressure, oxygen saturation, tem-
Renal failure after perature, inspired and expired gas concentra-
cardiac surgery
tions and even cerebral function [10]. A single
Stroke or death after
anesthetic can thus generate thousands of data
carotid stenting
Stroke or death after
points per hour of intraoperative care.
carotid surgery Before the tools of the Information Age made
Mortality after aortic the collection and manipulation of big data fea-
aneurysm stenting sible there were a number of anesthesia data
Venous thrombosis collection projects based on understanding spe-
prophylaxis after total cific populations of patients. The most useful of
knee replacement
these was without doubt the ASA Closed Claims
Antibiotics prior to
tourniquet during total Project [11]. This repository was based on the
knee replacement manual abstraction of data by expert anesthesi-
Unplanned hospital ologists from the medical and legal records of
admission after a patients who filed malpractice claims following
surgical procedure adverse outcomes. The Closed Claims research-
Rate of surgical site
ers worked behind the scenes with malpractice
infection
insurance providers to confidentially review a
OR operating room, ICU intensive care unit, PACU post-
anesthesia care unit sample of records from cases which have been
resolved in the legal system. The reviewers cap-
tured dozens of objective data elements such as
The History of Anesthesia Registries the surgical case, the type of anesthesia, the
patient age and the outcome of the legal pro-
Anesthesia is a data-rich medical discipline, ceedings, and combine this information with a
with a history of systematic capture of vital narrative describing the course of the case and
signs, medications and fluids that goes back to the complication. The Closed Claims review
the early days of surgery. Harvey Cushing and began in the mid-1980s and has continued to the
E.A Codman famously competed as medical stu- present, with more than 10,000 total records in
dents in 1895 to see who could produce the the repository. The project has generated two to
smoothest anesthetic; this rivalry depended on five papers a year in the anesthesia literature
726 R.P. Dutton
since 1990, and has provided an excellent and specialty. More information regarding AIRS,
ongoing description of the most serious anesthe- including the library of published case reports,
sia complications, beginning with an overview can be found at https://www.aqihq.org/airsIntro.
of morbidity and mortality related to anesthesia aspx.
(dominated in the 1980s and 1990s by failed air-
way management) [12]. Recent topics have
included unintended awareness under anesthe- Wake Up Safe
sia [13], injuries in the course of chronic pain
management [14] and malpractice related to A similar, but more focused, effort was launched
acute hemorrhage [15]. While not quantita- in about 2000 by the Society for Pediatric
tive—Closed Claims reports cannot provide the Anesthesia (SPA). Wake Up Safe (WUS) is a
true incidence of complications because the registry of case reports from adverse events
denominator is not usually known—these occurring during pediatric anesthesia [17].
papers provide guidance for how to change and Participating institutions commit to recording
evolve present practice and what are key risk each event from a mutually agreed list of serious
areas in present practices. The Closed Claims complications, using a standardized data capture
reports have been highly influential in changing form which draws heavily on objective informa-
the practice of care in these areas. tion from the medical record. Forms are then
The Closed Claims Project is limited by the sent to a central clearinghouse for entry into the
expense involved in expert review of charts, by registry, analyzed by a SPA workgroup, and
the inability to measure the risk of the complica- translation into public knowledge through infor-
tions seen (because the denominator informa- mal and formal academic channels. Each institu-
tion—the number of patients at risk—is tion also provides the registry with background
unknown), and by the time lag between the information on the numbers and types of pediat-
occurrence of the adverse event and the com- ric anesthesia performed, enabling estimation of
plete resolution of the malpractice case. This last risk rates for common complications. For the
limitation means that Closed Claims information represented demographic segment—children
lags current clinical practice by 3–5 years. The having major surgery in specialty hospitals—
Anesthesia Quality Institute (AQI) launched the WUS is an important source of information on
Anesthesia Incident Reporting System (AIRS) in the safety of pediatric anesthesia [18].
2011 to address these limitations. The AIRS
enables any anesthesia provider, anywhere in the
world, to submit confidential case reports regard-
ing unsafe conditions, near misses or anesthetic ediatric Regional Anesthesia
P
complications [16]. Each case report captures Network (PRAN)
similar objective information to the Closed
Claims reports, as well as a narrative from the The Pediatric Regional Anesthesia Network
provider themselves. While AIRS reports are (PRAN), captures data on all regional anesthesia
more variable in quality than those generated by cases completed in 22 participating facilities
the small pool of closed claims experts, they [19]. A standard case report form is filled out for
benefit from much greater proximity of the every case, usually by the anesthesiologist. The
reporter to the actual event. The AQI AIRS registry is maintained by the Colorado Children’s
Steering Committee actively reviews all col- Hospital, in collaboration with the University of
lected reports. Emerging trends in patient safety Washington. This registry now includes more
are examined—e.g., complications related to than 110,000 cases, and has been used for a num-
robotic surgery—and exemplary cases are “fic- ber of descriptive papers and comparative effec-
tionalized” and then presented as teaching exer- tiveness studies in the subspecialty of pediatric
cises in the ASA Monitor, for the education of the anesthesia [20].
The MPOG Registry Table 43.3 Papers published using data from the
Multicenter Perioperative Outcomes Group (MPOG)
The Multicenter Perioperative Outcomes Group • Bender SP, Paganelli WC, Gerety LP, Tharp WG,
Shanks AM, Housey M, Blank RS, Colquhoun DA,
(MPOG) is a consortium of anesthesia depart-
Fernandez-Bustamente A, Jameson LC, Kheterpal
ments working to aggregate clinical anesthesia S. Intraoperative lung-protection ventilation trends
data for research and quality improvement [21]. and practice patterns: a report from the multicenter
Each participating institution uses an Anesthesia perioperative outcomes group. Anesth Analg. 2015
Information Management System (AIMS) to dig- • Kheterpal S, Healy D, Aziz M, Shanks A,
Freundlich RE, Linton F, Martin LD, Linton J, Epps
itally capture electronic anesthesia records. JL, Fernandez-Bustamante A, Jameson LC,
Idiosyncratic local data are translated into a com- Tremper T, Tremper KK. Incidence, predictors, and
mon registry format that permits uniform aggre- outcomes of difficult mask ventilation combined
gation of records from multiple information with difficult laryngoscopy: a report from the
Multicenter Perioperative Outcomes Group.
technology (IT) platforms. While setting up and Anesthesiology. 2013
maintaining the IT mapping can be a challenge, • Bateman BT, Mhyre JM, Ehrenfeld J, Kheterpal S,
the end result is the ability to automatically trans- Abbey KR, Argalious M, Berman MF, Jacques PS,
fer information on every case to the registry, Levy W, Loeb RG, Paganelli W, Smith KW,
without the need for additional human abstrac- Wethington KL, Wax D, Pace NL, Tremper KK,
Sandberg WS. The risk and outcomes of epidural
tion but maintaining common definitions of hematomas after perioperative and obstetric
important variables. MPOG began as a collabora- epidural catheterization: a report from the
tion of academics but has recently received fund- Multicenter Perioperative Outcomes Group research
ing to promote anesthesia quality improvement in consortium. Anesth Analg. 2012
the state of Michigan, which it has used to begin • Freundlich E, Kheterpal S. Perioperative
effectiveness of research using large databases. Best
data collection from community hospitals. To Pract Res Clin Anaesthesiol. 2011
facilitate regulatory reporting for participants, • Kheterpal S. Clinical research using an information
MPOG has created a QCDR based on measures system: the multicenter perioperative outcomes
of intraoperative anesthesia process which can be group. Anesthesiol Clin. 2011
automatically calculated from the registry data. • Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D,
Brambrink AM. Routine clinical practice
Table 43.3 shows the publication dates and topics effectiveness of the Glidescope in difficult airway
of scholarly papers based on MPOG data. management: an analysis of 2004 Glidescope
intubation, complications, and failures from two
institutions. Anesthesiology. 2011
he National Anesthesia Clinical
T
Outcomes Registry (NACOR)
The easiest of these to obtain—and the starting
The Anesthesia Quality Institute (AQI) was cre- point for any participating practice—are the
ated by action of the ASA House of Delegates in group’s “administrative data,” or billing records.
2008, to “become the primary source for quality Far from being too simple to be useful, anesthesia
improvement in the clinical practice of anesthesi- billing records include about 20 consistently
ology.” The specific mission of the AQI was to defined data points for every anesthetic. These
create and maintain a registry of anesthesia cases data provide an important source of truth about
and outcomes, using modern information tech- the demographics of the practice, and anesthesia
nology [22]. NACOR was announced in 2009, nationally. This layer of information in NACOR
with the early participation of six pioneering provides a backdrop for subsequent assessment
anesthesia practices, and case data collection of outcomes—gathered by about 25 % of partici-
began on January 1, 2010. Since that time, growth pating practices—by providing the denominator
and penetration of NACOR has been rapid needed for calculation of risk and occurrence
(Fig. 43.1). NACOR was created on a model of rates. Definitions of administrative data elements
automated harvest of existing electronic records. are generally quite uniform, although gathered
728 R.P. Dutton
Fig. 43.1 Growth of the

National Anesthesia
Clinical Outcomes
Registry (NACOR) from
2010 to 2014. Top
panel = growth in cases in
the registry; Bottom
panel = growth in number
of participating practices
through dozens of different billing companies ing (e.g., the time of antibiotic administration)
each with its own proprietary software system. but many admirably exceed this baseline by cap-
Fortunately, the needs of the end-users of this turing the occurrence of anesthetic complications
data—Medicare and private insurance compa- such as postoperative pain, nausea and vomiting,
nies—force consistency in defining otherwise corneal abrasion, or serious safety issues such as
complex elements such as surgical case type, intraoperative cardiac arrest, pneumothorax after
facility type, and mode of anesthesia. central line placement, major medication error,
Once an automated reporting routine has been and anaphylaxis. Anesthesia quality capture sys-
created to harvest a group’s administrative data, tems are generally limited to the time of direct
the quest for outcome information begins. More contact with the patient, from preoperative
than half of all practices in the USA have mecha- assessment through PACU discharge. This fea-
nisms in place to digitally record the short-term ture necessarily limits the outcomes which can be
outcomes of each case, and case-by-case reports transmitted to NACOR to those which are readily
can be automatically transmitted to NACOR on a observed in this time frame: data on intraopera-
regular basis [22]. Many of these systems are tar- tive cardiac arrest are likely complete and accu-
geted directly at the data needed for PQRS report- rate, whereas capture of myocardial
infarction—typically diagnosed 3–5 days post- anesthesiologists themselves. Larger facilities

operatively—is not realistic. A second limitation tend to follow the first model, but with a steady
is that events are self-reported and thus unveri- rise in outpatient anesthesia there are now cloud-
fied. While the clinician involved is obviously the based stand-alone AIMS customized specifically
best situated to record a complication, doing so for use in offices, surgery centers and other
requires time and energy. Further, as pay for per- remote locations [25]. As anesthesia practice
formance systems advance there may be signifi- groups become larger, many find themselves
cant financial incentives to avoid reporting working with different software in different
serious adverse events due to fear of loess of locations, making aggregation of case informa-
income and professional prestige [23]. In prac- tion for practice- wide quality improvement a
tice, the accuracy of self-reported outcomes var- significant challenge.
ies with the culture of safety in the group, and Although only 6 years old, NACOR has already
these data must be taken with a grain of salt by inspired a number of investigators studying both
users of registry data [24]. narrow and broad topics in American anesthesia.
A third level of participation in NACOR is Table 43.4 shows a sample of publications based
achieved by the groups able to transmit clinical on NACOR data.
information from their AIMS. (Fig. 43.2 shows
the relative quantities of data available at each
level.) Electronic anesthesia records are used in
30–50 % of cases nationwide, supported by a NACOR vs. Surgical Registries
dozen different software platforms. These vary
from modules of enterprise-wide electronic The model for data aggregation followed by
health care records (EHRs) such as Epic and NACOR is substantially different from that fol-
Cerner to stand-alone products designed by lowed by the Society for Thoracic Surgeons
Fig. 43.2 Quantities of

data of different types in
NACOR, as of April 1,
2015
730 R.P. Dutton
Table 43.4 Papers published using data from the National Anesthesia Clinical Outcomes Registry (NACOR)
• Whitlock EL, Feiner JR, Chen LL. Perioperative mortality, 2010 to 2014: a retrospective cohort study using the
National Anesthesia Clinical Outcomes Registry. Anesthesiology. 2015
• Pollak KA, Stephens LS, Posner KL, Rathmell JP, Fitzgibbon DR, Dutton RP, Michna E, Domino KB. Trends
in pain medicine liability. Anesthesiology. 2015
• Schonberger RB, Dutton RP, Dai F. Is there evidence for systematic upcoding of ASA physical status coincident
with payer incentives? A regression discontinuity analysis of the National Anesthesia Clinical Outcomes
Registry. Anesth Analg. 2015
• Flood P, Dexter F, Ledolter J, Dutton RP. Large heterogenuity in mean durations of labor analgesia among
hospitals reporting to the American Society of Anesthesiologists’ Anesthesia Quality Institute. Anesth Analg.
2015
• Gabriel RA, Lemay A, Beutler SS, Dutton RP, Urman RD. Practice Variations for carotid endarterectomies and
associated outcomes. J Cardiothorac Vasc Anesth. 2015
• Chang B, Kaye AD, Diaz JH, Westlake B, Dutton RP, Urman RD. Complications of non-operating room
procedures: outcomes from the National Anesthesia Clinical Outcomes Registry. J Patient Saf. 2015
• Dexter F, Dutton RP, Kordylewski H, Epstein RH. Anesthesia workload nationally during regular workdays and
weekends. Anesth Analg. 2015
• Nunnally ME, O’Connor MF, Kordylewski H, Westlake B, Dutton RP. The incidence and risk factors for
perioperative cardiac arrest observed in the National Anesthesia Clinical Outcomes Registry. Anesth Analg.
2015
• Dutton R, Lee L, Stephens L, Posner K, Davies J, Domino, K. (2014, September). Massive hemorrhage: a
report from the anesthesia closed claims project. Anesthesiology. 2014
• Shapiro FE, Jani SR, Liu X, Dutton RP, Urman RD. (2014, June). Initial results from the National Anesthesia
Clinical Outcomes Registry and overview of office-based anesthesia. Anesthesiol Clin. 2014
• Deiner, S., Westlake, B., Dutton, RP. Patterns of surgical care and complications in elderly adults. J Am Geriatr
Soc. 2014
• Fleischut PM, Eskreis-Winkler JM, Gaber-Baylis LK, Giambrone GP, Faggiani SL, Dutton RP, Memtsoudis
SG. Variability in anesthetic care for total knee arthroplasty: an analysis from the Anesthesia Quality Institute.
Am J Med Qual. 2014
• Wanderer, J. Infographics in anesthesiology: resident anesthetic case types: what types of cases do
anesthesiology residents spend their time performing? Anesthesiology. 2014
(STS) registry of cardiac surgery cases [26] or case in every participating facility, NSQIP is
the National Surgical Quality Improvement forced to sample both surgical case types (only
Project (NSQIP) of the American College of certain operations are included) and patients
Surgeons [27]. These surgical registries obtain (only the first few in any month are included).
data through the efforts of an army of abstrac- Considering that any single type of surgical pro-
tors—usually experienced nurses—who comb cedure, e.g., total knee replacement, represents at
through medical records to find the data elements most 3 % of the volume of anesthetics for a prac-
desired by the registry. This model results in tice for a year, the use of hand abstraction would
greater completeness and consistency of records, be prohibitively expensive if any kind of a com-
especially when the abstractors can be centrally prehensive view of anesthesia care was desired.
trained and supported, but comes at a substantial Indeed, one of the limitations of NSQIP data may
cost. The estimated “throughput” of a nurse be a relative bias towards cases performed in
abstractor is from 300 to 1000 cases per year, large, academic institutions which can afford the
depending on the number of fields in each record, costs of participation.
at a cost of about $100,000 per abstractor per In practice, the data aggregation models of
year. Most large hospitals require two to three NACOR (accepting everything available in elec-
abstractors to meet the load of cases. While STS, tronic form) and NSQIP (specifically abstract
focused on the low-volume but high importance the desired fields) are converging. NSQIP is
domain of cardiac surgery, can abstract every seeking ways to reduce the manual abstraction
burden by importation of data directly from the facilities and vendors that might otherwise be
medical record, while NACOR is seeking greater tempted to promote parochial outcome defini-
consistency and completeness of data submis- tions [5]. Harmonization of common definitions
sion supported by the increased penetration and for perioperative antibiotic dosing, for example,
complexity of AIMS. Over time, more university is a development priority of the National Quality
and large private hospital systems are creating Forum because of the need for multiple special-
their own “data warehouses” to integrate clinical ties to collect and report this information to
and administrative records from across the enter- CMS (National Quality Forum, personal
prise, for the purpose of generating reports to communication).
multiple stakeholders, including clinical regis- The need for a universal patient identifier—
tries [28]. currently unavailable because of patient privacy
concerns in the USA, but standard practice in
many progressive health care systems. Australia,
The Digital Future UK and Norway have been doing this for over a
decade. With the mobility of the US consumer, not
One way in which clinical registries can advance to mention the shifting landscape of hospital and
is by ongoing visualization of the desired future surgery center affiliations, the clinical need to link
state. This is especially productive in the IT today’s record with the patient’s past and future
arena because, in general, what is actually being care has never been greater. The ability to link
accomplished in health care lags behind what is patients and encounters across multiple registries
possible in other industries. Future registries will will unlock a trove of new scientific advances. For
be built on a common language of medical ter- example, linking anesthesia process data from
minology that stretches across all specialties and NACOR to surgical outcomes from NSQIP would
disciplines, meaning that “myocardial infarc- allow us to understand the role of pain manage-
tion” in one registry will have the same defini- ment in hospital length of stay or link the type and
tion in all others. Initiatives such as SNoMed quantity of fluid resuscitation to the potential for
(Standard Nomenclature in Medicine) and adverse cardiac events a week later.
RxNorm are efforts in this direction, and the The registries of the future will benefit from
recent implementation in the United States of collaborative design and implementation. One
International Classification of Diseases, version example is the Maternal Quality Improvement
10 (ICD-10) coding of patient conditions and Project (MQIP), jointly sponsored by the ASA
procedures will help. In perioperative care the and the American Congress of Obstetricians and
International Organization for Terminology in Gynecologists (ACOG) [30]. This new registry
Anesthesia (IOTA) meets on a regular basis to project (currently enrolling a first wave of pilot
develop the fundamental linguistic building sites) is based on the implementation of common
blocks for all terminology [29]. These terms can clinical documentation software templates across
be assembled to describe any condition or proce- multiple sites, such that routine documentation of
dure required, at a degree of specificity that can care by doctors and nurses is easy to translate
be shared across different facilities, software directly into the data fields in the national regis-
systems and national borders. try. This will enable collection of homogeneous
Macro political forces including government data across sites, without the expense of abstrac-
reimbursement programs and regulatory agen- tors reviewing every record.
cies are adding pressure from above. The rise of Linkage of registries will lead naturally to
Pay for Performance in the USA is creating an collaborative registry projects, like MQIP. These
industry in the development of rational, vali- will support the next important quality improve-
dated clinical measures. When these appear, and ment initiative in health care: the idea of shared
are linked to payment incentives, they will create accountability with hypertransparency. Any
standardization and uniformity of data across health care experience, even a simple outpatient
732 R.P. Dutton
surgery, involves complex coordination of mul- Table 43.5 Core anesthesia data collected for every case
in the National Anesthesia Clinical Outcomes Registry
tiple professionals, from surgeons to anesthesi-
(NACOR)
ologists to nurses and therapists and technicians
• Case identifier
delivered by the surgical microsystem [31].
• Facility (supported by metadata: facility type,
Attempting to measure the performance of any location, size)
single individual in this effort misses the fact • Patient sex
that the patient’s outcome will be driven more by • Patient age
their ability to coordinate as a team than by the • Patient ZIP code (can be linked to median family
individual efforts of any of them [32]. In a per- income and other descriptors)
formance measurement system driven by shared • ASA Physical Status
accountability, the patient’s outcome (e.g., mor- • Date of procedure
tality after cardiac surgery) would be “owned” • Start time of procedure
by all of the participants in the patient’s care, • Stop time of procedure
including the surgical team, the anesthesia team • Surgical procedure(s) (expressed as CPT code)
and the hospital [33]. The ASA has made an • Anesthetic procedure(s) (expressed as CPT code)
early effort in this direction by listing measures • Anesthesia type
• Anesthesia provider(s) (supported by metadata:
developed by surgical societies (e.g., wound
provider age, training, board certification status)
infection after total knee replacement, time to
ASA American Society of Anesthesiologists, CPT Current
extubation after coronary artery bypass) as Procedural Terminology
reportable by anesthesiologists participating in
the NACOR QCDR (see Table 43.5). The logical
next step—working directly with the surgical amounts of clinical data in a common format.
societies to develop shared measures—has not Further, leveraging this data for ongoing quality
yet occurred. Potential targets for collaboration improvement is a competitive advantage that
might be the incidence of metastasis after cancer large group practices use to win hospital con-
surgery (influenced by both surgical technique tracts, negotiate better rates from payers and
and anesthetic modification of the inflammatory attract groups for acquisition or partnership.
response) and long-term cognitive function after Many large group practices, like the most-
pediatric cardiac surgery [34]. technologically savvy university systems, cur-
rently support their own clinical data warehouses.
While the primary purpose of these registries is to
linical Data Warehouses and Large
C support billing and collections, they are also the
Group Practices ideal destination for process and outcome data
elements used for regulatory reporting (PQRS)
The future of data-driven quality improvement and internal quality improvement. These regis-
in the USA may soon shift from the traditional tries are used by the most progressive practices to
university systems and national organizations to benchmark providers, develop hospital quality
a new entity: the large group practice. These are dashboards and support scientific research. Large
umbrella corporations incorporating multiple group warehouses suffer from the same informa-
anesthesia practices, created to bring economies tion technology challenges as national registries,
of scale to the increasingly complex business of including the cost of building interfaces, the need
surgical care. The largest of these now include for homogeneous data definitions, the lack of
thousands of providers, care for patients in hun- methodological expertise, and the willingness of
dreds of hospitals—often over wide geographic hospitals and providers to contribute [35].
areas—and perform in excess of a million cases However, large group practices have strong finan-
a year. One of the efficiencies delivered by these cial incentives for success, central control of data
businesses is a unified billing and practice man- formats, the resources to hire information tech-
agement approach that inevitably unites large nology professionals and the agility to make and
execute decisions quickly. The future of anesthe- system (including both facilities and physicians) a
sia quality improvement may well be driven more single global bundle payment for a given proce-
by these organizations than by specialty-society dure, rather than the current fragmented fee-for-
sponsored registries. service collections. The PSH experiments are
One area in which the private sector is clearly being deployed in hundreds of sites across the
outpacing public organizations is in the collec- USA, in service lines ranging from total joint
tion, analysis and utilization of patient experience replacement and coronary artery bypass grafting
data. “Patient centered outcomes” are a national (the most common) to colorectal surgery, urology,
goal advanced in the USA by the Affordable Care and even pediatric spinal procedures. Overall
Act and promoted by the Patient Centered patient outcome, e.g., rate of return to work or
Outcomes Research Institute (PCORI), a new— school within 30 days of knee replacement, will
and well-funded—federal agency [36]. While be one of the metrics by which the success of
CMS, the American Medical Association and to these experiments is judged, but gathering and
some degree the specialty societies have been analyzing these data will require the creation of
locked into the Healthcare Consumer Assessment new, collaborative registries in the perioperative
of Hospitals and Provider Survey (HCAHPS) and arena.
the monopolistic private company which runs it
[37], large group practices have had the agility to
leap a technical generation ahead, deploying ther National Anesthesia Registry
O
anesthesia-specific patient satisfaction surveys— Projects
sometimes within hours of the anesthetic in ques-
tion—that interact with the patient through Most of this chapter has focused on US registries,
smartphone and internet based technology [38]. and the influences of America’s unique reim-
In contrast, HCAHPS surveys are administered bursement and incentive environment. Anesthesia
by phone, 60–90 days after discharge, and do not registry efforts are also underway in many other
include detailed questions regarding the patient’s countries, and include both focused collections of
experience with anesthesia. Large group practices adverse events and comprehensive census regis-
that have deployed their own surveys, and pro- tries capturing data from routine care.
vided the results as periodic feedback to their pro- The Scandinavian countries, with a long his-
viders, have seen substantial improvement in tory of organized national health care, have the
patient satisfaction (US Anesthesia Partners, per- most general experience with health care regis-
sonal communication). This trend, in turn, has tries, facilitated by national level patient identifi-
been advantageous in winning hospital contracts ers that enable tracking of individuals across
and favorable insurance contracts. Patient cen- different hospitals. Denmark and Sweden have
tered outcomes, because of their holistic nature notable national surgical registries described in
and high face validity, fit naturally into the con- numerous publications, yet neither has a national-
cept of shared accountability described above. level registry focused specifically on anesthesia
They will also be one key measure of another care. Anesthesiologists in Sweden are working to
emerging trend in perioperative care: the concept create such a system now, building on the exist-
of enhanced recovery (ERAS—see Chap. 22 ing surgical project, and will likely have central-
above) and the perioperative surgical home ized data within a few years [40].
(PSH—see Chap. 46 above). This idea, strongly The Japanese Society of Anesthesiologists is
advanced by the ASA, espouses close coordina- just beginning work on a national census registry,
tion of the entire surgical episode under one team based on automated data extraction from elec-
[39]. The intent is to design and manage the flow tronic records [41]. Beginning with those institu-
of routine perioperative care to enable effective tions—largely urban university hospitals—that
and efficient delivery, consistent with a near- currently have AIMS, the Japanese Registry has
future payment model that assigns the health care been growing rapidly as the enabling health care
734 R.P. Dutton
information technology penetrates into every challenged on the premise that data about a par-
hospital. ticular surgery occurring on a particular day
The Swiss maintain the Critical Incident could be easily reassociated with a particular
Reporting System (CIRS), which is open to all patient. The German federal high court, in keep-
European nations as a central repository of ing with a strong public culture protecting patient
adverse events and unusual complications in confidentiality, ordered the registry closed and
anesthesia [42]. Reporting is through the internet, the existing 18 months of data destroyed. It
using a standard form that is completed by the remains to be seen if this same argument will
anesthesia provider. This system has been used to compromise other anesthesia registries main-
generate a number of reports and alerts regarding tained in the European Union.
complications in anesthesia.
The British conduct National Anesthesia
Practice Survey (NAPS) audits on a regular basis Summary
focused on particular high risk topics as part of a
national requirement of clinical audit and quality Anesthesiology, as a specialty, is as data inten-
improvement [43]. All hospitals in the National sive as any other in the house of medicine. It is
Health Service complete reports of total cases not surprising, therefore, that registry efforts in
(denominator) and the occurrence of the compli- anesthesia are flourishing in the Information Age.
cation (numerator) for defined audit periods. Anesthesia registries are already providing a
Data are gathered and analyzed centrally, and greatly expanded understanding of the scope and
findings are published and widely distributed to scale of anesthesia care today. Whether this
affected providers. Recent efforts have examined understanding will lead to improvements in
difficult airway management (NAPS 4) [44] and patient care remains to be clearly demonstrated;
the occurrence of unintended awareness during collecting data is easy, but transforming it into
anesthesia (NAPS 5) [45]. clinical knowledge is the hardest challenge of all.
The Australian Anesthesia Incident Monitoring Many methodological questions about validity
Study began in the early 1990s as a project similar and reliability of the day including how general-
to the ASA’s Closed Claims Project or AIRS, but izable are the data remain to be worked out.
became a rapidly adopted standard for collecting
complications of anesthesia care [46]. In the
2000s, this registry was expanded to all medical References
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Use of Data from Surgical
Registries to Improve Outcomes 44
Jeffrey P. Jacobs
“So I am called eccentric for saying in public that hospitals, if they wish to be sure of
improvement:
• must find out what their results are
• must analyze their results …
• must compare their results with those of other hospitals
• must welcome publicity not only for their successes, but for their errors
Such opinions will not be eccentric a few years hence.”
—Ernest Amory Codman, Surgeon. Massachusetts General Hospital, 1917
medicine: Structure, Process, and Outcome [6],

Introduction and this conceptual model became known as
Donabedian’s Triad (Fig. 44.2). In 2010, Michael
The art and science of outcomes analysis, quality E. Porter, Ph.D. defined value in healthcare as
improvement, and patient safety continue to evolve “health outcomes achieved per dollar spent” [7].
at an increasingly rapid pace, and surgery leads Although this definition is often quoted as:
many of these advances (Fig. 44.1) [1, 2]. The “value = quality/cost” (Fig. 44.3), the original
American College of Surgeons National Surgical manuscript written by Porter published in The
Quality Improvement Program® (ACS NSQIP®) [3] New England Journal of Medicine describes the
and The Society of Thoracic Surgeons (STS) following equation: “value = outcome/cost,” per-
National Database [4] exemplify this leading role, haps demonstrating that the key component of
as they each provide a platform for the generation of Donabedian’s Triad is outcome!
important new knowledge in all of these domains. This chapter is titled: “Use of Data from Surgical
In order to better care for patients and to be Registries to Improve Outcomes.” In reality, most
successful in today’s rapidly evolving healthcare surgical registries and databases serve multiple pur-
environment, understanding these topics is an poses: the analysis of outcomes, the improvement
essential professional responsibility of all sur- of quality, and research (Fig. 44.4). And it is a fact
geons. According to the Merriam-Webster dic- that the border separating the domains of quality
tionary, quality is defined as “how good or bad and research may be blurred and vary across institu-
something is” [5]. In 1966, Avedis Donabedian tions and Institutional Review Boards (IRBs) [8].
(7 January 1919 to 9 November 2000) published Nevertheless, in order to perform meaningful multi-
the theory that three domains of quality exist in institutional analyses of outcomes, any database
should strive to incorporate the following seven
essential elements [1, 2, 9, 10]:
J.P. Jacobs, MD, FACS, FACC, FCCP (*)
Division of Cardiovascular Surgery, 1 . Use of a common language and nomenclature,
Johns Hopkins All Children’s Heart Institute, 2. An established uniform core dataset for col-
Johns Hopkins All Children’s Hospital,
lection of information,
Johns Hopkins University, 601 Fifth Street South,
Suite 607, Saint Petersburg, FL 33701, USA 3. Incorporation of a mechanism to evaluate and
e-mail: [email protected] account for case complexity,

738 J.P. Jacobs
Fig. 44.1 This figure depicts the intersecting domains of Fig. 44.4 This figure depicts three goals of surgical reg-
outcomes, quality, and safety istries: the intersecting domains of outcomes, quality, and
research
4. Availability of a mechanism to assure and

verify the completeness and accuracy of the
data collected,
5. Collaboration between medical and surgical
subspecialties,
6. Standardization of protocols for lifelong fol-
low-up, and
7. Incorporation of strategies for quality assess-
ment and quality improvement.
Fig. 44.2 In 1966, Avedis Donabedian (7 January 1919
to 9 November 2000) published the theory that three This chapter briefly describes two of the lead-
domains of quality exist in medicine: Structure, Process, ing surgical databases in the world: ACS NSQIP
and Outcome [6], and this conceptual model became and the STS National Database. This chapter
known as Donabedian’s Triad
then examines the seven elements described
above, using ACS NSQIP and the STS National
Database to exemplify important principles.
Examples of Surgical Databases
he American College of Surgeons

T
Fig. 44.3 In 2010, Michael E. Porter, Ph.D. defined value
National Surgical Quality
in healthcare as “health outcomes achieved per dollar Improvement Program® (ACS NSQIP®)
spent” [7]. Although this definition is often quoted as:
“value = quality/cost”, the original manuscript written by The American College of Surgeons National
Porter and published in The New England Journal of
Surgical Quality Improvement Program (ACS
Medicine describes the following equation: “value = out-
come/cost”, perhaps demonstrating that the key compo- NSQIP®) is the only nationally benchmarked,
nent of Donabedian’s Triad is outcome! clinical, risk-adjusted, outcomes based program
44 Use of Data from Surgical Registries to Improve Outcomes 739
in the USA that is designed to measure and cardiac surgical database in the world and con-
improve care across the surgical specialties [3, tains data from over 90 % of the hospitals that per-
11]. ACS NSQIP is a nationally benchmarked, form adult cardiac surgery in the USA. STS-CHSD
peer-controlled database that allows hospitals to is the largest pediatric cardiac surgical database in
compare 30-day patient outcomes to hospitals the world and contains data from over 95 % of the
of all sizes and types across the country. ACS hospitals that perform pediatric cardiac surgery in
NSQIP uses data that are: the USA. STS-GTSD is the largest clinical regis-
try of general thoracic operations in the world. All
• From the patient’s medical chart, not insur- three component database of STS National
ance claims Database function as platforms for outcomes
• Risk-adjusted analysis, quality improvement, and research.
• Case-mix-adjusted
• Based on 30-day patient outcomes
ey Components of Surgical
K
Databases
he Society of Thoracic Surgeons
T
National Database se of a Common Language
U
and Nomenclature
The STS National Database was established in
1989 as an initiative to enhance the quality and The first step in creating a surgical registry is
safety of cardiothoracic surgery and to provide an developing a standardized nomenclature so that
accurate and valid basis for measuring perfor- all diagnoses and procedures are coded uniformly
mance in our specialty [4, 12, 13]. The STS across centers. Ample data exists demonstrating
National Database has thus far had five chairs: the limitations of administrative systems of
Richard E. Clark (1989–1997), Frederick nomenclature that were designed for billing and
L. Grover (1997–2004), Fred H. Edwards (2004– not for the analysis of outcomes [14–18]. A uni-
2010), David M. Shahian (2010–2015), and versal clinical system of nomenclature is the
Jeffrey P. Jacobs (2015– ). The STS National foundation of any surgical registry.
Database has three major component databases,
each focusing on a different area of cardiothoracic
surgery: the STS Adult Cardiac Surgery Database n Established Uniform Core Dataset
A
(ACSD), the STS Congenital Heart Surgery for Collection of Information
Database (CHSD), and the STS General Thoracic
Surgery Database (GTSD) (Fig. 44.5) [4, 12, 13]. Once a system of nomenclature is established,
Table 44.1 documents the size and penetration of the next step is creating a platform of data collec-
the three major component databases of the STS tion with a shared minimal dataset and standard-
National Database. STS-ACDS is the largest adult ized definitions for fields of data.
Fig. 44.5 The STS National Database has three major Database (ACSD), the STS Congenital Heart Surgery
component databases, each focusing on a different area Database (CHSD), and the STS General Thoracic
of cardiothoracic surgery: the STS Adult Cardiac Surgery Surgery Database (GTSD)
740 J.P. Jacobs
Table 44.1 Society of Thoracic Surgeons (STS) National Database participation [12]
Society of Thoracic Surgeons (STS) National Database Participationa
STS Congenital STS General
STS Adult Cardiac Heart Surgery STS Congenital Cardiac Thoracic
Surgery Databasea Databasea Anesthesia Modulea,b Databasea
Participantsc in USA 1113 116 50 301
Hospitalsd in USA 1105 127 59 353
Surgeons in USA 2937 361 441 (anesthesiologists) 883
e
Operations in USA 5,142,262 345,108 64,506 416,984
States in USA 50 39 27 43
Estimated penetrance at >90–95 % of >95 % of 31.2%g ?h
the Hospital level in hospitals that hospitals that
USAf,g,h perform adult perform pediatric
heart surgeryf heart surgeryg
Percentage of Programs 44 % 33 % Public reporting is not Public reporting is
in USA that voluntarily available not yet available.
publicly report Voluntary public
reporting with
GTSD is planned
for 2017
Total countries 9 5 1 4
(including USA)i
Participants outside 13 6 0 3
USA
Hospitalsd outside USA 18 6 0 3
Surgeons outside USA 39 15 0 9
Operationse outside 5594 10,655 0 0
USA
Total Participants 1126 122 50 304
Total Hospitalsd 1123 132 59 356
Total Surgeons 2976 376 441 892
Total Operationse 5,741,489 355,763 64,506 416,984
a
Data updated on September 25, 2015
b
The STS Congenital Cardiac Anesthesia Module was developed jointly by STS and Congenital Cardiac Anesthesia
Society (CCAS)
c
An STS Database Participant is either a “practice group of cardiothoracic surgeons” or, uncommonly, an individual
cardiothoracic surgeon. In the majority of instances, an STS Database Participant is a hospital cardiac or thoracic sur-
gery program
d
In most situations, one STS Database Participant is linked to one hospital; however, in some instances, one STS
Database Participant is linked to more than one hospital or one hospital is linked to more than one STS Database
Participant. Therefore, the number of STS Database Participant and the number of hospitals is slightly different
e
Total number of operations refers to the total number of operations in each database since the databases began storing
data at Duke Clinical Research Institute (DCRI) in 1998. DCRI is the data warehouse and analytic center for ACSD,
CHSD, and GTSD
f
Center-level penetration (number of CMS sites with at least one matched STS participant divided by the total number
of CMS CABG sites) increased from 45 % in 2000 to 90 % in 2012. In 2012, 973 of 1081 CMS CABG sites (90 %) were
linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations done at STS sites divided by
the total number of CMS CABG hospitalizations) increased from 51 % in 2000 to 94 % in 2012. In 2012, 71,634 of
76,072 CMS CABG hospitalizations (94 %) occurred at an STS site. Completeness of case inclusion at STS sites (num-
ber of CMS CABG cases at STS sites linked to STS records divided by the total number of CMS CABG cases at STS
sites) increased from 88 % in 2000 to 98 % in 2012. In 2012, 69,213 of 70,932 CMS CABG hospitalizations at STS sites
(97 %) were linked to an STS record. (Reference: Jacobs JP, Shahian DM, He X, O'Brien SM, Badhwar V, Cleveland
JC Jr, Furnary AP, Magee MJ, Kurlansky PA, Rankin JS, Welke KF, Filardo G, Dokholyan RS, Peterson ED, Brennan
JM, Han JM, McDonald D, Schmitz D, Edwards FH, Prager RL, Grover FL. Penetration, Completeness, and
(continued)
Representativeness of The Society of Thoracic Surgeons Adult Cardiac Surgery Database. Ann Thorac Surg. 2016
Jan;101(1):33–41. doi: 10.1016/j.athoracsur.2015.08.055. Epub 2015 Nov 3. PMID: 26542437.)
g
The 2010 Society of Thoracic Surgeons Congenital Heart Surgery Practice and Manpower Survey estimates that 125
hospitals perform pediatric cardiac surgery in the USA and eight Hospitals perform pediatric cardiac surgery in Canada
(Jacobs ML, Daniel M, Mavroudis C, Morales DLS, Jacobs JP, Fraser CD, Turek JW, Mayer JE, Tchervenkov C, Conte
JV. Report of the 2010 Society of Thoracic Surgeons Congenital Heart Surgery Practice and Manpower Survey. Ann
Thorac Surg. 2011 Aug; 92:762–9.).
h
The penetration of the STS General Thoracic Surgery Database cannot be calculated because the number of General
Thoracic surgical programs in the USA (the denominator of penetration) is not known. (Reference [13] provides graphs
documenting the number of participants [the numerator of penetration] and surgeons in the STS General Thoracic Surgery
Database.)
i
Countries participating in the STS Adult Cardiac Surgery Database are: USA (50 states), Australia, Brazil, Canada,
India, Israel, Italy, Turkey, and United Arab Emirates. Countries participating in the STS Congenital Heart Surgery
Database are: USA (39 states), Canada (3 Canadian Provinces), Columbia, Turkey, and Saudi Arabia. Countries partici-
pating in the STS General Thoracic Database are: USA (43 states), Saudi Arabia, Singapore, and United Arab Emirates
In ACS NSQIP [3], each hospital assigns a the STS National Database are reported back to
trained Surgical Clinical Reviewer (SCR) to col- participants in Feedback Reports that include the
lect preoperative data through 30-day postopera- types of procedures performed; demographics
tive data on randomly assigned patients. The and risk factors of the patients; details about the
number and types of variables collected differs conduct of the surgical procedure; and outcomes.
from hospital to hospital, depending on the size In each database, individual institutional out-
of the hospital and the population of its patients, comes are benchmarked against aggregate data
and its quality improvement focus. The ACS pro- from all programs in the given database. Data in
vides SCR training, ongoing educational oppor- each of the STS National Database are either
tunities, and auditing, to ensure data reliability. entered by a trained abstractor (database manag-
Data are entered online in a HIPAA-compliant, ers) or entered by caregivers and carefully
secure, Web-based platform that can be accessed reviewed by the database manager. These data-
24 h a day. A surgeon champion assigned by each base managers work with surgeons, physician
hospital leads and oversees program implementa- assistants, nurse practitioners, and others to
tion and quality initiatives. Blinded, risk-adjusted ensure that that data entered into the STS National
information is shared with all hospitals, allowing Database adhere to the definitions established by
them to nationally benchmark their rates of com- STS and that they are supported by documenta-
plications and surgical outcomes. ACS also pro- tion in the patient’s medical record. These data
vides monthly conference calls, best practice managers have many resources available to them
guidelines, and many other resources to help hos- including:
pitals target problem areas and improve surgical
outcomes. • the detailed written database specifications
In each of the three STS National Databases • a teaching manual that expands upon the for-
[4], data are collected regarding patient demo- mal specifications and often includes clinical
graphics, preoperative factors that may impact examples
the outcomes of surgery, details of the specific • advice of colleagues in regional collaboratives
disease process that led to the surgery (e.g., around the nation
degree of coronary artery stenosis in each vessel • bi-weekly telephone calls with leaders of the
[19], etiology and severity of valvar lesions, type STS National Database and Duke Clinical
of thoracic aortic pathology, stage of lung cancer, Research Institute (DCRI), the data warehouse
or esophageal cancer, type of congenital cardiac and analytic center for all STS databases
lesion); technical details of the conduct of the • e-mail alerts
operation that was performed; detailed clinical • newsletters and
outcomes; and disposition of the patient (e.g., • a four-day annual national meeting attended
home, rehabilitation facility, or dead). Data from by hundreds of data managers from around the
742 J.P. Jacobs
country (at which data managers and surgeon ite performance metrics may be utilized that
leaders present educational sessions on chal- combine the outcome domains of mortality and
lenging coding issues and new developments morbidity [26]; this strategy is important because
in data specifications). of progressively decreasing mortality rates and
because survival is only one measure of the qual-
Standardization of definitions of all fields in the ity of care. For example, consider two patients
database is essential [19]. For example, Operative who undergo the same surgical repair of an
Mortality is defined in all STS databases as (1) all abdominal aortic aneurysm. Patient one recovers
deaths, regardless of cause, occurring during the with no complications. Patient two survives but
hospitalization in which the operation was per- has a postoperative stroke, develops dialysis
formed, even if after 30 days (including patients dependent renal failure, and needs a gastrostomy
transferred to other acute care facilities); and (2) because of an inability to swallow after the stroke.
all deaths, regardless of cause, occurring after dis- These two patients will both count as survivors in
charge from the hospital, but before the end of the a model that only measures mortality; however, a
30th postoperative day [20, 21]. multi-domain composite that includes postopera-
tive morbidity will differentiate the outcomes of
these two patents. Such composite measures pro-
vide more end points and also a much more com-
I ncorporation of a Mechanism prehensive assessment of quality of care, because
to Evaluate and Account for Case such composites include both risk-adjusted mor-
Complexity tality and risk-adjusted morbidity.
After standardizing nomenclature and establishing

a database with defined fields of data, the next step
is the incorporation of a mechanism to evaluate and vailability of a Mechanism to Assure
A
account for case complexity. Case mix can vary and Verify the Completeness
between surgeons and hospitals. Risk adjustment is and Accuracy of the Data Collected
essential when assessing and comparing healthcare
performance among programs and surgeons, as this Once one has a developed a standardized nomen-
adjusts for differences in the complexity and sever- clature, a core database, and a system to adjust for
ity of patients they treat. Reliably accounting for variations in case mix, the next step is to assure
the risk of adverse outcomes mitigates the possibil- the completeness and the accuracy of the data.
ity that providers caring for sicker patients will be Three potential strategies may ultimately allow
unfairly penalized because their unadjusted results for optimal verification of data:
may be worse simply because of case mix. A vari-
ety of strategies exist to adjust for variations in case 1. Intrinsic data verification (designed to rectify
mix [22]. Risk models can adjust for variations in inconsistencies of data and missing elements
the preoperative status of patients and the overall of data)
case mix of a given provider. 2. Site visits with “Source Data Verification” (in
Three fundamental issues in health care per- other words, verification of the data at the pri-
formance measurement must be addressed when mary source of the data)
comparing the performance of providers and hos- 3. External verification of the data from indepen-
pitals: selection of a homogeneous target popula- dent databases or registries (such as govern-
tion, risk adjustment, and assignment of quality mental death registries).
rating categories [22]. Differences in provider
classification may result from these methodo- Data quality in all STS databases is evaluated
logic decisions [22–25]. Multi-domain compos- through intrinsic data verification by DCRI
(including identification and correction of miss- comparative effectiveness research. Several

ing/out of range values and inconsistencies across potential strategies will allow longitudinal fol-
fields). In addition to intrinsic data verification by low-up with the surgical registries, including
DCRI, each year, approximately 10 % of partici- the development of clinical longitudinal fol-
pants in all STS databases are randomly selected low-up modules within the surgical registry
for audits of their center. The audit is designed to itself, and linking the surgical registry to other
complement the internal quality controls, with an clinical registries, administrative databases,
overall objective of maximizing the integrity of and national death registries:
the data in all STS databases by examining the
completeness and accuracy of the data. STS has 1. Using probabilistic matching with shared

selected Telligen (http://www.telligen.com/) to indirect identifiers, surgical registries can be
perform these independent, external audits. As linked to administrative claims databases
the state of Iowa’s Medicare Quality Improvement (such as the CMS Medicare Database [8, 30]
Organization (QIO), Telligen partners with health and the Pediatric Health Information System
care professionals to assure high quality, cost [PHIS] database [31]) and become a valuable
effective health care. As a QIO, Telligen is source of information about long-term mortal-
HIPAA compliant and performs audits adhering ity, rates of rehospitalization, long-term mor-
to strict security policies. bidity, and cost [34].
2. Using deterministic matching with shared
unique direct identifiers, surgical registries can
be linked to national death registries like the
ollaboration Between Medical
C Social Security Death Master File (SSDMF)
and Surgical Subspecialties [32, 33] and the National Death Index (NDI) in
order to verify life-status over time.
It is often stated that caring for surgical patients is 3. As described in the preceding section, through
a “team endeavor,” bringing together a variety of either probabilistic matching or deterministic
professionals to maximize the outcomes [27, 28]. matching, surgical registries can link to multi-
The harmonization of nomenclature and database ple other clinical registries, such as the National
standards between medical and surgical databases Cardiovascular Data Registry (NCDR) of the
can enhance the science of outcomes analysis and American College of Cardiology (ACC), in
quality improvement and benefit our patients [29]. order to provide enhanced clinical follow-up.
Medical and surgical databases can be linked 4. Surgical registries can develop clinical longi-
through a variety of strategies including linkage tudinal follow-up modules of their own to pro-
based on indirect identifiers using probabilistic vide detailed clinical follow-up.
matching [8, 30, 31] and linkage with direct iden-
tifiers using deterministic matching [8, 32, 33].
I ncorporation of Strategies
tandardization of Protocols
S for Quality Assessment and Quality
for Lifelong Follow-up Improvement
One weakness of most surgical registries is A major goal of all surgical registries is to func-
their inability to provide longitudinal outcomes. tion as a platform for quality improvement. The
The transformation of a surgical registry into a simple act of benchmarking individual institu-
platform for longitudinal follow-up will ulti- tional data to national aggregate data can facili-
mately result in higher quality of care for all tate quality improvement. Multi-institutional
surgical patients by facilitating longitudinal registries can identify high performing outliers
744 J.P. Jacobs
and low performing outliers. Quality improve- endorsement is the gold standard for health care
ment initiatives can be initiated in “low perform- quality measures, and NQF-endorsed measures
ing centers” and best practices can be identified are recognized by the national healthcare com-
by studying structure and processes of care at munity as “best in class,” evidence-based, and
“high performing centers.” valid. Both ACS and STS (Table 44.2) have
The National Quality Forum (NQF) [http:// developed quality measures that are endorsed
www.qualityforum.org/Home.aspx] is a multi- by NQF (Table 44.2), and both specialty based-
stakeholder, nonprofit, membership-based orga- medical professional organizations are stewards
nization that aims to improve the quality of for more NQF-endorsed measures than any
healthcare through the preferential use of only other professional surgical society (Table 44.3).
the most valid performance measures. NQF
Table 44.2 NQF endorsed measures of STS [12]

NQF # Measure title Domain
1 0113 Participation in a systematic database Adult
for cardiac surgery
2 0114 Risk-adjusted postoperative renal Adult
failure
3 0115 Risk-adjusted surgical re-exploration Adult
4 0116 Anti-platelet medication at discharge Adult
5 0117 Beta blockade at discharge Adult
6 0118 Anti-lipid treatment discharge Adult
7 0119 Risk-adjusted operative mortality for Adult
CABG
aortic valve replacement (AVR)
mitral valve (MV) Replacement
mitral valve (MV)
Replacement + CABG Surgery
aortic valve replacement
(AVR) + CABG surgery
12 0126 Selection of antibiotic prophylaxis for Adult
cardiac surgery patients
13 0127 Preoperative beta blockade Adult
14 0128 Duration of antibiotic prophylaxis for Adult
cardiac surgery patients
15 0129 Risk-adjusted postoperative prolonged Adult
intubation (Ventilation)
16 0130 Risk-adjusted deep sternal wound Adult
infection
17 0131 Risk-adjusted stroke/cerebrovascular Adult
accident
18 0134 Use of internal mammary artery (IMA) Adult
in coronary artery bypass graft (CABG)
(continued)
NQF # Measure title Domain
19 0455 Recording of clinical stage prior to Thoracic
surgery for lung cancer or esophageal
cancer resection
20 0456 Participation in a systematic national Thoracic
database for general thoracic surgery
21 0457 Recording of performance status prior Thoracic
to lung or esophageal cancer resection
22 0459 Risk-adjusted morbidity: length of stay Thoracic
>14 days after elective lobectomy for
lung cancer
23 0460 Risk-adjusted morbidity and mortality Thoracic
for esophagectomy for cancer
24 0696 STS CABG composite score Adult
25 0732 Surgical volume for pediatric and Congenital
congenital heart surgery: total
programmatic volume and
programmatic volume stratified by the 5
STAT Mortality Categories
26 0733 Operative mortality stratified by the 5 Congenital
STAT Mortality Categories
27 0734 Participation in a national database for Congenital
pediatric and congenital heart surgery
mitral valve (MV) repair
mitral valve (MV) repair + CABG
surgery
30 1790 Risk-adjusted morbidity and mortality Thoracic
for lung resection for lung cancer
31 2514 Risk-adjusted coronary artery bypass Adult
graft (CABG) readmission rate
32 2561 STS aortic valve replacement (AVR) Adult
composite score
33 2563 STS aortic valve replacement Adult
(AVR) + coronary artery bypass graft
(CABG) composite score
34 2683 Risk-adjusted operative mortality for Congenital
pediatric and congenital heart surgery
Graphical Depiction of Outcomes Data Multiple examples of thoughtful graphical

depiction of clinical data can be seen in The
Thoughtful graphical depiction of clinical data American College of Surgeons National Surgical
will serve multiple purposes and enhance com- Quality Improvement Program (ACS NSQIP®)
munication [35]. Such enhanced communication and The STS National Database. Figures 44.6 and
is important on multiple levels including com- 44.7 are caterpillar plots derived from NSQIP®
munication amongst health care professionals (Fig. 44.6) [41] and The STS National Database
and communication between health care profes- (Fig. 44.7) [24]. Figure 44.8 is a funnel plot [42]
sionals and our patients [36–40]. derived from The STS National Database [43].
746 J.P. Jacobs
Table 44.3 Stewards of NQF endorsed measures [12]
# NQF endorsed
Steward measures
1 Centers for Medicare & Medicaid Services 118
2 National Committee for Quality Assurance 81
3 Agency for Healthcare Research and Quality (AHRQ) 55
4 American Medical Association (AMA)-convened Physician Consortium for 37
Performance Improvement (PCPI)
5 The Society of Thoracic Surgeons 34
6 The Joint Commission 32
7 American College of Cardiology 26
8 The Child and Adolescent Health Measurement Initiative 18
9 Centers for Disease Control and Prevention 14
10 American Society of Clinical Oncology 13
11 American College of Surgeons 11
12 MN Community Measurement 9
13 American Dental Association on behalf of the Dental Quality Alliance 7
14 American Gastroenterological Association 7
15 American Medical Association 7
16 Focus on Therapeutic Outcomes, Inc. 7
17 RAND Corporation 7
18 University of Minnesota Rural Health Research Center 7
19 American Academy of Neurology 6
20 American College of Rheumatology 6
21 Society for Vascular Surgery 6
22 American College of Emergency Physicians 5
23 College of American Pathologists 5
24 University of North Carolina-Chapel Hill 5
25 American Academy of Ophthalmology 4
26 American Nurses Association 4
27 Health Resources and Services Administration—HIV/AIDS Bureau 4
28 Pharmacy Quality Alliance 4
29 American Society of Hematology 4
30 Ambulatory Surgical Centers Quality Collaborative 3
31 American Health Care Association 3
32 American Urogynecologic Society 3
33 Boston Children’s Hospital 3
34 Bridges To Excellence 3
35 Leapfrog Group 3
36 Oregon Health & Science University 3
37 Virtual PICU Systems, LLC 3
(continued)
# NQF endorsed
Steward measures
38 Renal Physicians Association 3
39 American Academy of Dermatology 2
40 American Association of Cardiovascular Pulmonary Rehabilitation 2
41 American Medical Directors Association 2
42 American Podiatric Medical Association 2
43 American Society of Anesthesiologists (ASA) 2
44 ASC Quality Collaboration 2
45 California Maternal Quality Care Collaborative 2
46 CREcare 2
47 Department of Health Policy, The George Washington University 2
48 HealthPartners 2
49 Kidney Care Quality Alliance 2
50 Massachusetts General Hospital 2
51 National Hospice and Palliative Care Organization 2
52 Optum 2
53 Philip R. Lee Institute for Health Policy Studies 2
54 American Thoracic Society 2
55 The Children’s Hospital of Philadelphia 2
56 Vermont Oxford Network 2
57 Center of Excellence for Pediatric Quality Measurement 2
58 Heart Rhythm Society 2
59 American Heart Association/American Stroke Association 1
60 American Society for Radiation Oncology 1
61 American Urological Association 1
62 Brigham and Women’s Hospital 1
63 Christiana Care Health System 1
64 City of New York Department of Health and Mental Hygiene 1
65 Deyta, LLC 1
66 Health Benchmarks-IMS Health 1
67 Henry Ford Hospital 1
68 Hospital Corporation of America 1
69 National Assoc. of State Mental Health Program Directors Research Instit., 1
Inc. (NRI)
70 American Society of Addiction Medicine 1
71 Uniform Data System for Medical Rehabilitation, a division of UB Foundation 1
Activities, Inc. and its successor in interest, UDSMR, LLC
72 University of Colorado Denver Anschutz Medical Campus 1
73 Department of Veterans Affairs/Hospice and Palliative Care 1
74 University of Pennsylvania, Center for Health Outcomes and Policy Research 1
Total 626
748 J.P. Jacobs
Fig. 44.6 This caterpillar plot demonstrates program- estimate and the vertical bar representing the 95 % confi-
matic observed-to-expected (O/E) ratios for prolonged dence interval. More successful performers lie to the left.
ventilation greater than 48 h for general surgical patients. Better than expected outliers have Confidence Interval
The bold arrow indicates a hypothetical program that is [CI] entirely below the mean [horizontal black line].
interested in comparing its performance to aggregate data. Worse than expected outliers have Confidence Interval
For this hypothetical institution, the O/E ratio is 1.5. [CI] entirely above the mean [horizontal black line].
(Each vertical line corresponds to the result of one par- Shaded green and pink are outliers [41]
ticular hospital, with the orange dot representing the point
Fig. 44.7 This caterpillar plot demonstrates program- cal bar representing the 95 % confidence interval. Outliers
matic observed-to-expected (O/E) ratios for risk adjusted with lower than expected Operative Mortality have
Operative Mortality using the STS Congenital Heart Confidence Interval [CI] entirely below the mean [hori-
Surgery Database Mortality Risk Model. (Each vertical zontal dashed line]. Outliers with higher than expected
line corresponds to the result of one particular hospital, Operative Mortality have Confidence Interval [CI] entirely
with the dot representing the point estimate and the verti- above the mean [horizontal dashed line] [24]
References
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Fernandez FG, Wright C, Fann JI, Paone G, Sanchez Work Force: clarifying the definition of operative
JA, Cleveland Jr JC, Brennan JM, Dokholyan RS, mortality. World J Pediatr Congenit Heart Surg.
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Patient Safety. Ann Thorac Surg. 2015;100(6):1992– SM. Issues in quality measurement: target population,
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of state administrative databases for surveillance of 23. O’Brien SM, Jacobs JP, Pasquali SK, Gaynor JW,
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Mol Teratol. 2003;67:597–603. Shahian DM, Jacobs ML. The Society of Thoracic
15. Frohnert BK, Lussky RC, Alms MA, Mendelsohn NJ, Surgeons Congenital Heart Surgery Database Mortality
Symonik DM, Falken MC. Validity of hospital dis- Risk Model: part 1-statistical methodology. Ann
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MD, Mahle WT, Botto LD, Tolbert PE, Jacobs ML, Jr JE, Karamlou T, Welke KF, Filardo G, Han JM, Kim
Lacour-Gayet FG, Tchervenkov CI, Mavroudis C, S, Quintessenza JA, Pizarro C, Tchervenkov CI, Lacour-
Correa A. The importance of nomenclature for con- Gayet F, Mavroudis C, Backer CL, Austin 3rd EH,
genital cardiac disease: implications for research and Fraser CD, Tweddell JS, Jonas RA, Edwards FH, Grover
evaluation. In: Jacobs JP (editor) 2008 Cardiology in FL, Prager RL, Shahian DM, Jacobs ML. The Society of
the young supplement: databases and the assessment Thoracic Surgeons Congenital Heart Surgery Database
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vol 18, Issue S2 (Suppl. 2), pp 92–100; 2008. JW, Gaies MG, Peterson ED, Hirsch-Romano JC,
17. Pasquali SK, Peterson ED, Jacobs JP, He X, Li JS, Mayer JE, Jacobs JP. Impact of patient characteristics
Jacobs ML, Gaynor JW, Hirsch JC, Shah SS, Mayer on hospital-level outcomes assessment in congenital
JE. Differential case ascertainment in clinical registry heart surgery. Ann Thorac Surg. 2015;100(3):1071–7.
versus administrative data and impact on outcomes doi:10.1016/j.athoracsur.2015.05.101. Epub 2015
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athoracsur.2012.08.074. Epub 2012 Nov 7.h. Badhwar V, Cleveland Jr JC, Fazzalari FL, Filardo G,
18. Jantzen DW, He X, Jacobs JP, Jacobs ML, Gaies MG, Normand SL, Furnary AP, Magee MJ, Rankin JS,
Hall M, Mayer JE, Shah SS, Hirsch-Romano J, Welke KF, Han J, O’Brien SM. The Society of
Gaynor JW, Peterson ED, Pasquali SK. The impact of Thoracic Surgeons Composite Measure of Individual
differential case ascertainment in clinical registry ver- Surgeon Performance for Adult Cardiac Surgery: a
sus administrative data on assessment of resource uti- report of The Society of Thoracic Surgeons Quality
lization in pediatric heart surgery. World J Pediatr Measurement Task Force. Ann Thorac Surg.
Congenit Heart Surg. 2014;5(3):398–405. PMID: 2015;100(4):1315–25. doi:10.1016/j.athorac-
24958042, [Epub ahead of print]. sur.2015.06.122. Epub 2015 Aug 29.
19. Barach P, Lipshultz S. The benefits and hazards of 27. Cohen M, Jacobs JP, Quintessenza JA, Chai PJ,
publicly reported quality outcomes. Progr Pediatr Lindberg HL, Dickey J, Ungerleider RM. Mentorship,
Cardiol. 2016;42:45–9. doi:10.1016/j.ppedcard. learning curves, and balance. In 2007 Supplement to
2016.06.001. Cardiology in the Young: Controversies and Challenges
20. Jacobs JP, Mavroudis C, Jacobs ML, Maruszewski B, Facing Paediatric Cardiovascular Practitioners and
Tchervenkov CI, Lacour-Gayet FG, Clarke DR, Yeh their Patients, Anderson RH, Jacobs JP, and Wernovsky
T, Walters 3rd HL, Kurosawa H, Stellin G, Ebels T, G, editors. Cardiol Young. 2007;17 Suppl 2:164–74.
Elliott MJ. What is operative mortality? Defining doi:10.1017/S1047951107001266.
death in a surgical registry database, a report from the 28. Jacobs JP, Wernovsky G, Cooper DS, Karl
STS Congenital Database Task Force and the Joint TR. Principles of shared decision-making within teams.
EACTS-STS Congenital Database Committee. Ann Cardiol Young. 2015;25(8):1631–6. doi:10.1017/
Thorac Surg. 2006;81(5):1937–41. S1047951115000311. Epub 2015 Aug 18.
21. Overman D, Jacobs JP, Prager RL, Wright CD,
29. Jacobs JP, editor. 2008 Supplement to Cardiology in
Clarke DR, Pasquali S, O’Brien SM, Dokholyan the Young: databases and the assessment of compli-
RS, Meehan P, McDonald DE, Jacobs ML, cations associated with the treatment of patients
Mavroudis C, Shahian DM. Report from The with congenital cardiac disease, prepared by: the
Multi-societal Database Committee for Pediatric of pediatric cardiac surgery. Progr Pediat Cardiol.
and Congenital Heart Disease. Cardiol Young. 2011;32:147–53.
2008; 18(suppl S2):1–530. 36. Jacobs JP, Cerfolio RJ, Sade RM. The ethics of

30. Jacobs JP, Edwards FH, Shahian DM, Haan CK,
transparency: publication of cardiothoracic surgical
Puskas JD, Morales DLS, Gammie JS, Sanchez JA, outcomes in the lay press. Ann Thorac Surg.
Brennan JM, O’Brien SM, Dokholyan RS, Hammill 2009;87(3):679–86.
BG, Curtis LH, Peterson ED, Badhwar V, George 37. Shahian DM, Edwards FH, Jacobs JP, Prager RL,
KM, Mayer Jr JE, Chitwood WR, Murray GF, Grover Normand SL, Shewan CM, O’Brien SM, Peterson
FL. Successful linking of The Society of Thoracic ED, Grover FL. Public reporting of cardiac surgery
Surgeons Adult Cardiac Surgery Database to Centers performance: part 1-history, rationale, consequences.
for Medicare and Medicaid Services Medicare Data. Ann Thorac Surg. 2011;92(3 Suppl):S2–11.
Ann Thorac Surg. 2010;90:1150–7. 38. Shahian DM, Edwards FH, Jacobs JP, Prager RL,
31. Pasquali SK, Jacobs JP, Shook GJ, O’Brien SM, Hall Normand SL, Shewan CM, O’Brien SM, Peterson
M, Jacobs ML, Welke KF, Gaynor JW, Peterson ED, ED, Grover FL. Public reporting of cardiac surgery
Shah SS, Li JS. Linking clinical registry data with performance: part 2-implementation. Ann Thorac
administrative data using indirect identifiers: imple- Surg. 2011;92(3 Suppl):S12–23.
mentation and validation in the congenital heart sur- 39. Shahian DM, Grover FL, Prager RL, Edwards FH,
gery population. Am Heart J. 2010;160:1099–104. Filardo G, O’Brien SM, He X, Furnary AP, Rankin
32. Jacobs JP, Edwards FH, Shahian DM, Prager RL, JS, Badhwar V, Cleveland Jr JC, Fazzalari FL, Magee
Wright CD, Puskas JD, Morales DL, Gammie JS, MJ, Han J, Jacobs JP. The Society of Thoracic
Sanchez JA, Haan CK, Badhwar V, George KM, Surgeons voluntary public reporting initiative: the
O’Brien SM, Dokholyan RS, Sheng S, Peterson ED, first 4 years. Ann Surg. 2015;262(3):526–35.
Shewan CM, Feehan KM, Han JM, Jacobs ML, doi:10.1097/SLA.0000000000001422.
Williams WG, Mayer Jr JE, Chitwood Jr WR, Murray 40. Lopez C, Hanson C, Yorke D, Johnson J, Mill M,
GF, Grover FL. Successful linking of the Society of Brown K, Barach P. Improving communication with
Thoracic Surgeons Database to Social Security Data families of patients undergoing pediatric cardiac
to examine survival after cardiac operations. Ann surgery. Progr Pediatr Cardiol. Accepted 9 July
Thorac Surg. 2011;92(1):32–9. 2016.
33. Jacobs JP, O’Brien SM, Shahian DM, Edwards FH, 41. McNelis J, Castaldi M. The National Surgery Quality
Badhwar V, Dokholyan RS, Sanchez JA, Morales Improvement Project” (NSQIP): a new tool to increase
DL, Prager RL, Wright CD, Puskas JD, Gammie patient safety and cost efficiency in a surgical inten-
JS, Haan CK, George KM, Sheng S, Peterson ED, sive care unit. Patient Safe Surg. 2014;8:190.
Shewan CM, Han JM, Bongiorno PA, Yohe C, 42. Spiegelhalter DJ. Funnel plots for comparing institu-
Williams WG, Mayer JE, Grover FL. Successful link- tional performance. Stat Med. 2005;24:1185–202.
ing of the Society of Thoracic Surgeons Database 43. Jacobs JP, O’Brien SM, Pasquali SK, Jacobs ML,
to Social Security data to examine the accuracy of Lacour-Gayet FG, Tchervenkov CI, Austin 3rd EH,
Society of Thoracic Surgeons mortality data. J Thorac Pizarro C, Pourmoghadam KK, Scholl FG, Welke
Cardiovasc Surg. 2013;145(4):976–83. doi:10.1016/j. KF, Mavroudis C, Richard E. Clark paper: variation
jtcvs.2012.11.094. in outcomes for benchmark operations: an analysis
34. Barach P, Lipshultz S. Readmitting children with heart of the Society of Thoracic Surgeons Congenital
failure: the importance of communication, coordina- Heart Surgery Database Richard Clark Award recipi-
tion, and continuity of care. J Pediatr. 2016;177:13–6. ent for best use of the STS Congenital Heart Surgery
PII: S0022-3476(16)30562-5. Database. Ann Thorac Surg. 2011;92(6):2184–92.
35. Johnson J, Barach P. Quality improvement meth-
44. Barach P. The end of the beginning. J Legal Med.
ods to study and improve the process and outcomes 2003;24:7–27.
Part V
Regulation, Policy, and the Future
of Surgical Care
How Regulators Assess and
Accredit Safety and Quality 45
in Surgical Services
Stephen Leyshon, Tita Listyowarodojo Bach,
Eva Turk, Aileen Orr, Bobbie N. Ray-Sannerud,
and Paul Barach
“The spectacles of experience; through them you will see clearly a second time.”
—Henrik Ibsen
inpatient surgical procedures. It is estimated that

Background 0.4–0.8 % of these major complications result in
permanent disability or death [2].
Systems Thinking and Surgical Safety Despite research and global safety initiatives
over the past decade demonstrating that surgical
With an estimated annual 234 million surgeries
complications can be preventable, reports suggest
performed worldwide, surgery has become an
that adverse events continue to occur at alarming
inherent part of health care [1], corresponding
rates [4]. In an attempt to mitigate risk, there is an
to one operation for every 25 people alive [2].
increased global recognition on the need to
Performing surgical procedures is risky [3].
develop standards, requirements, and recommen-
For example, in industrialized countries, major
dations within surgical centers. The World Health
complications are estimated to occur in 3–16 %
Organization (WHO) launched the Safe Surgery
Saves Lives campaign in January 2007 to improve
consistency of surgical care and adherence to
S. Leyshon, MSc, MA, RN, DN, FHEA (*)
T.L. Bach, PhD, DNV, GL, AS
safety practices. The Surgical Safety Checklist
E. Turk, PhD, MBA, DNV, GL, AS was created through an international consultative
B.N. Ray-Sannerud, PsyD, DNV, GL, AS process. The checklist is a 2-min tool, much like
Strategic Research and Innovation, Healthcare the checklist a pilot uses before takeoff, and is
Program, Veritasveien 1, Høvik, Oslo 1363, Norway
designed to help operating room staff improve
[email protected]; teamwork and ensure the consistent use of safety
[email protected]; processes [5]. In the U.S., as an example, national
[email protected] regulatory groups have been established to focus
A. Orr, BA (Hons), DNV, GL, AS on integrating and advocating a quality standard
Healthcare UK, Palace House, 3 Cathedral Street, for health care. These regulatory groups include
London SE1 9DE, UK
for example DNV GL, Joint Commission on
P. Barach, BSc, MD, MPH, Maj (ret.) Accreditation of Health Care Organizations, the
Foundation and Kyle John Rymiszewski Research
National Quality Forum, the Agency for
Scholar, Children’s Hospital of Michigan, Healthcare Research and Quality, the National
Wayne State University School of Medicine, Committee on Quality Assurance, and the
5057 Woodward Avenue, Suite 13001, Detroit, Leapfrog Group [2, 6]. More recently in 2014, the
MI 48202, USA
Surgical Never Events Taskforce developed a

756 S. Leyshon et al.
series of recommendations for new standards and able information maintained or collected by these
systems to further develop and improve the safety agencies differs greatly. Therefore, it is difficult to
of surgery in UK hospitals [7]. reach overall conclusions about the relative
quality of care provided across all categories of
outpatient and inpatient surgical settings, for gen-
Quality of Care in Surgery Settings eral surgery or for subspeciality procedures.
The ideal way to ensure quality of care is to have

internal quality assurance processes within each omparison of Current Assurance
C
individual setting, and to have an external means Schemes in Surgical Safety: National
of measuring quality of care across settings, for and International
similar procedures. If each provider is vigilant in
benchmarking/tracking quality indicators and is Many clinicians and hospital administrators won-
engaged in continuous efforts to improve patient der how regulators assess safety and quality in sur-
outcomes, patient health and safety will be better gical services. Accreditation is a process of review
protected [8]. State licensing, federal certifica- that health care organizations participate in to dem-
tion, and accreditation standards all require some onstrate their ability to meet predetermined criteria
level of internal quality assurance. and standards of accreditation established by a pro-
However, from an external perspective, quality fessional accrediting agency. The health care orga-
of care is most often measured through determin- nization or ambulatory surgery center pays a fee to
ing compliance with minimum state, federal, or the accreditation organization (AO) for the costs
accreditation standards. Compliance is determined related to oversight of the setting.
through periodic surveys or complaint investiga- A quality assurance scheme of surgical ser-
tions. Data on compliance trends is collected by the vices can be in the form of a mechanism to ensure
state and federal government and accreditation that the end-users are going through a safe and
organizations, but there is very little data or analy- the least risky journey within the health care
sis that is routinely made available to the public organization, pursuing an outcome acceptable
about the quality of care in surgery settings. Further, by certain standards (http://www.asianhhm.com/
the data collected by external entities varies greatly surgical-speciality/quality-assurance). To date,
in its rigor and requirements, and quality compari- there are very few assurance schemes targeting
sons across all setting categories for the same pro- surgical safety. In Table 45.1, we document
cedures are not possible at the current time. examples of assurance schemes related to surgi-
Other mechanisms for measuring quality may cal safety. These examples show that surgical
include research studies or quality indicators. assurance schemes are still patchy and vary
However, there have been very few published stud- highly from one practice to another, and from one
ies, articles, or analysis about the quality of care in country to another. The examples are categorized
surgery and especially outpatient settings readily into the following types [9]: (1) national or inter-
available to the public. A growing public concern national, (2) Statutory regulation and institutional
relates to the question of how increased volumes of licensing, (3) or voluntary system (e.g., peer
specific procedures can minimize negative patient review and health care accreditation).
outcomes. This is consistent with other studies and The advantage of statutory regulations and
practices for other types of surgical procedures. institutional licensing as forms of assurance
Indeed, some state and federal standards require schemes is their visibility in that they mandate
minimum numbers of procedure as a condition of health care providers to change the way surgery
qualifying to perform those procedures. is organized and practiced. For example, the sur-
While each of these methods of measuring gical checklists introduced by the World Health
quality of care has benefits, they are often under Organization (WHO), which were designed and
the oversight authority of different agencies or implemented throughout the globe to help reduce
organizations (both public and private). The avail- surgical mortality and complications, have been
Table 45.1 Overview of international regulatory and quality assurance schemes
Statutory Year of
regulations and Regulators/ publication
Institutional organizations (between
National/ licensing/ Country, providing the 2000 and
international voluntary system if national requirements Keywords 2015) Brief description of assurance schemes Focus of assurance
Internationally Voluntary system ISO ISO 1988 Surgical
7151:1988 instruments—Non-
cutting, articulated
instruments—
General requirements
and test methods
Internationally Voluntary system ISO ISO 1991 Contains a survey and a selection of stainless Surgical
7153-1:1991 steels available for use in the manufacture of instruments—
surgical, dental and specific instruments for Metallic materials—
orthopedic surgery. It takes into account steel Part 1: Stainless steel
grades and chemical compositions
Internationally Voluntary system ISO ISO/DIS Under Standardization in the field of surgical Surgical
7153-1 development instruments such as forceps, scissors, scalpels instruments—
and retractors Materials—Part 1:
Metals
Internationally Voluntary system ISO ISO 1999
7153-1:1991/
45 How Regulators Assess and Accredit Safety and Quality in Surgical Services
Amd 1:1999
Internationally Voluntary system ISO ISO 1985 Lays down the dimensions of two sizes of Instruments for
7740:1985 fitting features for detacheable scalpel blades surgery—Scalpels
and the handles with which they are used. It with detachable
secures a good fitting and interchangeability of blades—Fitting
detachable blades for scalpels manufactured in dimensions
different countries or by different
manufacturers. The transitional period for a
gradual adaption of the fitting dimensions
specified in this standard should end with the
year 1990
757
(continued)
758
Statutory Year of
Internationally Voluntary system ISO ISO 1986 This standard deals with materials, heat Instruments for
7741:1986 treatment and hardness of component parts, surgery—Scissors
corrosion resistance, workmanship and cutting and shears—General
ability of scissors and shears used in the surgery requirements and test
and defines the test methods methods
Internationally Voluntary system ISO ISO 1995 Describes test methods to determine the Surgical and dental
13402:1995 resistance of stainless steel surgical and dental hand instruments—
hand instruments against autoclaving, corrosion Determination of
and thermal exposure resistance against
autoclaving,
corrosion and
thermal exposure
Internationally Voluntary system ISO ISO 2014 ISO 8828:2014 specifies the recommended Orthopedic implants
8828:2014 procedures for handling orthopedic implants,
hereafter referred to as implants, from receipt at
the hospital until they are implanted or
discarded.
This guidance applies to implants (such as
currently used metal, ceramic, or polymeric
implants) and also to acrylic resin and other
bone cements.
This guidance does not apply to the implant
manufacturer. However, it contains references
to the stocking of implants that can be useful
for manufacturers and especially for third-party
suppliers
S. Leyshon et al.
Statutory Year of
Internationally Voluntary system ISO ISO 2015 ISO 12891-1:2015 specifies the method to be Retrieval and
12891- followed for the retrieval and handling of surgical analysis of surgical
1:2015 implants and associated tissues and fluids. In implants—part 1:
particular, it specifies the essential steps to be retrieval and
followed for the safe and proper obtaining of the handling
clinical history, pre-explantation checks and
examinations, collection, labelling, cleaning,
decontamination, documentation, packing and
shipping. It also provides guidance on infection
control.
Note National or other regulations, which can be
more stringent, can apply.
ISO 12891-1:2015 does not apply in cases of
explantation where there is no intention to collect
retrieval data. However, many clauses give useful
information which can apply in these cases also.
ISO 12891-1:2015 specifies the method to be
followed for the retrieval and handling of surgical
implants and associated tissues and fluids. In
particular, it specifies the essential steps to be
followed for the safe and proper obtaining of the
clinical history, pre-explantation checks and

examinations, collection, labelling, cleaning,
decontamination, documentation, packing and
shipping. It also provides guidance on infection
control.
Note National or other regulations, which can be
more stringent, can apply.
ISO 12891-1:2015 does not apply in cases of
explantation where there is no intention to collect
retrieval data. However, many clauses give useful
information which can apply in these cases also
(continued)
759
760
Statutory Year of
Internationally Voluntary system ISO ISO ISO 12891-2:2014 specifies methods for the Retrieval and
12891- analysis of retrieved surgical implants. analysis of surgical
2:2014 ISO 12891-2:2014 describes the analysis of implants—part 2:
retrieved metallic, polymeric and ceramic analysis of retrieved
implants. The analysis is divided into three surgical implants
stages which are increasingly destructive.
ISO 12891-2:2014 can also be applied to other
materials, e.g. animal tissue implants.
ISO 12891-2:2014 can be applied in accordance
with national regulations or legal requirements
regarding the handling and analysis of retrieved
implants and tissues and associated biological
material
Internationally Voluntary system ISO ISO/TR ISO/TR 14283 provides fundamental principles Active or non-active
14283:2004 for the design and manufacture of active or implants
non-active implants in order to achieve the
intended purpose
Internationally Voluntary system ISO ISO/CD TR Under Implants for surgery
14283 development
Internationally Voluntary system ISO ISO 2007 ISO 14607:2007 specifies particular Non-active surgical
14607:2007 requirements for mammary implants for clinical implants—mammary
practice. implants
With regard to safety, ISO 14607:2007 specifies
requirements for intended performance, design
attributes, materials, design evaluation,
manufacturing, sterilization, packaging and
information supplied by the manufacturer
Internationally Voluntary system ISO ISO/WD Under Non-active surgical
14607 development implants—mammary
implants
S. Leyshon et al.
Statutory Year of
Internationally Voluntary system ISO ISO 2012 ISO 14630:2012 specifies general requirements for Non-active surgical
14630:2012 non-active surgical implants. ISO 14630:2012 is implants
not applicable to dental implants, dental restorative
materials, transendodontic and transradicular
implants, intra-ocular lenses and implants utilizing
viable animal tissue.
With regard to safety, ISO 14630:2012 specifies
requirements for intended performance, design
attributes, materials, design evaluation,
manufacture, sterilization, packaging and
information supplied by the manufacturer, and tests
to demonstrate compliance with these requirements
Internationally Voluntary system ISO ISO 2000 Minimum data sets for surgical implants Implants for surgery
16054:2000
Internationally Voluntary system ISO ISO 2015 ISO 16061:2015 specifies general requirements Instrumentation for
16061:2015 for instruments to be used in association with use in association
non-active surgical implants. These requirements with non-active
apply to instruments when they are manufactured surgical implants
and when they are resupplied after refurbishment.
This International Standard also applies to
instruments which may be connected to
power-driven systems, but does not apply to the

power-driven systems themselves.
With regard to safety, this International Standard
gives requirements for intended performance,
design attributes, materials, design evaluation,
manufacture, sterilization, packaging, and
information supplied by the manufacturer.
This International Standard is not applicable to
instruments associated with dental implants,
transendodontic and transradicular implants,
and ophthalmic implants
761
(continued)
762
Statutory Year of
Internationally Voluntary system ISO ISO/WD Under Non-active surgical
17327 development implants—implant
coating
Internationally Voluntary system ISO ISO/CD Under Cleaning of
19227 development orthopedic
implants—general
requirements
Internationally Voluntary system ISO ISO 2014 ISO 10282:2014 specifies requirements for Single-use sterile
10282:2014 packaged sterile rubber gloves intended for use rubber surgical
in surgical procedures to protect the patient and gloves
the user from cross-contamination. It is
applicable to single-use gloves that are worn
once and then discarded. It does not apply to
examination or procedure gloves. It covers
gloves with smooth surfaces and gloves with
textured surfaces over part or the whole glove.
ISO 10282:2014 is intended as a reference for
the performance and safety of rubber surgical
gloves. The safe and proper usage of surgical
gloves and sterilization procedures with
subsequent handling, packaging, and storage
procedures are outside the scope of ISO
10282:2014
Internationally Voluntary system ISO ISO 1994 Specifies the dimensions and mechanical Implants for
10334:1994 properties and gives test methods. The surgery—malleable
mechanical properties specified are tensile wires for use as
strength, elongation, and resistance to damage sutures and other
in bending and in torsion. Surface finish is not surgical applications
covered
S. Leyshon et al.
Statutory Year of
National Voluntary system The UK Association Quality 1992 (first The guidelines are addressed principally to Breast cancer
of Breast assurance publication), surgeons working in the screening program for screening program
Surgery guidelines updated in breast cancer, who will use the guidelines in a
(ABS) at for surgeons 1996, 2003, personal capacity to audit their own activity
BASO in breast 2009
cancer
screening
National Voluntary system Australia Queensland VLAD VLAD charts provide an effective, easily
Health, system visualized display of surgical performance and
Governmental can be applied to pediatric cardiac surgery.
organization Early detection of change, whether
improvement or deterioration, is important for
ongoing quality assurance within a cardiac
surgery program
National Voluntary system The UK Quality The implementation of a QAP improved quality
assurance of care in terms of consistency of patient
program selection and outcomes of surgery during a
(QAP) period of major reorganization of cancer
services in London. The QAP framework
presented could be adopted by other
organizations providing complex surgical care
across a large network of referring hospitals

International Voluntary system WHO Surgical The checklist identifies three phases of an
safety operation, each corresponding to a specific
checklists: period in the normal flow of work: Before the
induction of anesthesia (“sign in”), before the
incision of the skin (“time out”) and before the
patient leaves the operating room (“sign out”).
In each phase, a checklist coordinator must
confirm that the surgery team has completed the
listed tasks before it proceeds with the
operation
763
(continued)
764
Statutory Year of
National Voluntary system USA Accreditation Handbook
Association for small
for office-based
Ambulatory surgery
Health Care practices
(AAAHC)
National Statutory The UK Care Quality CQC inspection is based on the following In general clinics but
regulation and Commission questions: (1) are services safe, (2) are services include surgical
institutional (CQC) effective, (3) are services caring, (4) are practices
licensing services responsive to people’s needs, (5) are
servies well-led
International Voluntary system EU European European
Union guidelines
for quality
assurance in
breast cancer
screening
and
diagnosis
National Voluntary system USA American American Various surgical quality assurance programs Various surgical
College of College of within surgery, using four key principles services e.g. National
Surgeon Surgeons required to measurably improve quality of care Accreditation
National and increase value: (1) Standards, (2) Right Program for Breast
Surgical Infrastructure, (3) Rigorous data, (4) Centers (NAPBC),
Quality Verification Metabolic and
Improvement Bariatric Surgery
Program® Accreditation and
(ACS Quality Improvement
NSQIP®) Program
(MBASAQIP)
S. Leyshon et al.
Statutory Year of
National Voluntary system UK The Association Guidance on a number of perioperative issues Perioperative
for Periope e.g. best practice for safe handling of surgical
rative Practice sharps, PCC perioperative support worker, safer
(AfPP) surgery checklist, etc.
National Voluntary system UK The Royal Develop a range of guidance aimed to provide a
College of robust framework for promoting good practice
Surgeons of in surgery, professional development and
England effective delivery of surgical services e.g.
guidance for individual surgeons and for the
surgical team on professinalism and good
practice, guidance on day-to-day working
practices that facilitate and promote the
delivery of effective services, and guidance and
tools on appraisals and revalidation
National Voluntary system UK The Royal RCSEd develops a range of guidance aimed to
College of provide a robust framework for promoting good
Surgeons of practice in surgery, professional development
Edinburgh and effective delivery of surgical services
(RCSEd)
National Statutory Canada Accreditation Accreditation Canada’s sector and service-
regulation and Canada based standards help organizations assess
institutional quality at the point of service delivery. They are

licensing based upon five key elements of service
excellence: clinical leadership, people, process,
information, and performance.
These standards contain the following sections:
Investing in surgical care services.
Engaging prepared and proactive staff.
Providing safe and appropriate services.
Maintaining accessible and efficient clinical
information systems.
Monitoring quality and achieving positive
outcomes
765
(continued)
766
Statutory Year of
National Statutory France The Haute Provides practice guidelines in general that also
regulation and Autorité de include surgery services
institutional santé
licensing (HAS)—or
French
National
Authority for
Health
International Voluntary system EU The European The main activities of the EUMS can be
Union of summarized in four headings: Surgical training
Medical Standard of the Certificate of Completion of
Specialists Specialist Training (CCST)
(Union Continuing Medical Education in Surgery
Européenne (Continuing Professional Development)
des Médecins Surgical Quality Control
Spécialistes—
UEMS)
National Statutory USA Centers for Include conditions of participation for hospitals
regulation and medicare and with surgical services, for example: (1) If the
institutional medicaid hospital provides surgical services, the services
licensing services must be well organized and provided in
(CMS) accordance with acceptable standards of
practice. If outpatient surgical services are
offered the services must be consistent in
quality with inpatient care in accordance with
the complexity of services offered. (2) Surgical
procedures must be performed in a safe manner
by qualified physicians who have been granted
clinical privileges by the governing body of the
ASC in accordance with approved policies and
procedures of the ASC
S. Leyshon et al.
Statutory Year of
National Voluntary system USA Joint Include standards on Surgical Site Infection Hospital acquired
Commission (SSI) infections
(JC)
National Voluntary system USA Joint Include Surgical Care Improvement Project National quality
Commission (SCIP) partnership of
(JC) organizations
interested in
improving surgical
care by significantly
reducing surgical
complications
National Voluntary system USA Joint Office-based surgery accreditation Smaller surgical
Commission practices
(JC)
International Voluntary system Joint None found specific related to surgical services
Commission
International
(JCI)
International Voluntary system Accreditation None found specific related to surgical services
Canada
International
National Voluntary system Canada Accreditation Accreditation Canada’s sector and service-
Canada based standards are based upon five key
elements of service excellence: clinical
leadership, people, process, information, and
performance
National Voluntary system Canada Royal College Among their core functions is to accredit Residency programs
of Physicians medical education under two broad categories: and learning
and Surgeons (1) the residency programs sponsored by activities pursued by
of Canada Canada’s 17 medical schools, (2) and the physicians for
learning activities pursued by physicians who professional
engage in continuing professional development development
767
part of many national regulations in the USA and document provides guidance to surgeons wishing
Australia [10, 11]. Since 2012, the US Centers to perform robotic surgery to fulfill specific train-
for Medicare & Medicaid Services (CMS) ing prior to performing it.
requires ambulatory surgery centers (ASC) to Most surgical assurance schemes have a focus
conduct quality reporting that includes the use of mainly on prescriptive, rather than performance-
surgery checklists for all, not only Medicare, based frameworks. Whereas health care prac
patients [12, 13]. titioners need assurance schemes that are
Within voluntary schemes, it is worth noting performance-based to help them put systems
that non-governmental, private sector regulators thinking into practice. This is crucial to ensure
are rapidly gaining their influence in the way that that end-users receive the necessary treatment
surgery is practiced, billed and supervised [6]. with the desired outcome. There remains an evi-
For example, the Leapfrog Group [13] has dence gap forcing regulators to be ever vigilant
become one of the most powerful forces in the about the safety and reliability of surgical
private regulatory sector and provides excellent services [9].
evidence on the impact of this sector on surgical
care. Furthermore, specialty colleges or board
and professional licensing bodies are key players Outpatient/Ambulatory Surgery
in developing assurance schemes based on con-
sensus into more uniform, regulated schemes. National and international professional associa-
For example, there is a global trend in developing tions have published information about the qual-
and implementing a scheme for physicians’ con- ity of care provided in outpatient settings for
tinuous professional development such as schemes their own specialties, there have been very few
to maintain physicians’ competence [14]. In published studies, articles, or analyses about the
Australia, as an example, the Royal Australasian overall quality of care in outpatient surgery set-
College of Surgeons requires surgeons to maintain tings. In addition, there is little information about
their skills, knowledge and competence by self- the relative quality and safety of specific outpa-
directed learning, teaching, researching, publishing tient surgical procedures across the range of set-
scientific articles, and attending educational gath- tings in which these surgeries are performed.
erings such as scientific meetings, workshops, and Quality of care is most often measured by
seminars. In most of western countries, surgeons internal facility quality assurance processes, and
must retain records to verify their competence and by information collected by oversight agencies
professional development [14]. through determining compliance with minimum
The specialty colleges or boards can also state, federal, or accreditation standards. Data
potentially be the champions in closing the gap in may be collected by the state and federal govern-
the areas in need of regulations such as robotic ment, accreditation organizations, and internal
surgery. Technology advancements in surgery are facility quality assurance processes, but this data
growing rapidly, for example, the scale and is not analyzed in such a way as to reach a deter-
spread of 3-D organ and prosthetic printing. This mination about the quality of care, nor is this
growth creates an urgent need for assurance information readily available to the public.
schemes to ensure the quality and safety of In order to protect public health and safety,
patients not being harmed from the technology. and to provide more information about health
Currently, there are no standards, nationally care being provided in outpatient surgery set-
or internationally, for assuring patients are not tings, a fresh look at the oversight, transpar-
harmed during the use of robotic surgery. ency, and quality of care across all settings is
However, there is a growing consensus in this warranted. Some of the opportunities will
field, such as a consensus document produced by require additional analysis and stakeholder
The Society of American Gastrointestinal and involvement to develop and will take more time
Endoscopic Surgeons [15, 16]. This consensus than others.
45 How Regulators Assess and Accredit Safety and Quality in Surgical Services 769
uture Challenges in the Assessment

F accreditation in surgical centers, there is little
and Regulation of Surgical Safety research to empirically support this claim.
and Quality Recently two studies were published that exam-
ined the impact of accreditation in bariatric and
The Surgical Never Events Taskforce standards ambulatory surgical centers [19, 20]. The out-
provide an overarching framework with high comes of bariatric surgery performed compared
level descriptions of what should constitute stan- between those done at accredited versus non-
dard practice for peri-operative procedures that accredited centers using a nationally representa-
can be developed locally to create standardized tive database evaluated a total of 277,068
practices within organizations [7]. For surgical bariatric operations performed within a 3-year
centers that are required to meet specific stan- period. Results of the study indicated that accred-
dards or requirements that promote quality assur- itation in bariatric surgery was associated with
ance and improve the processes by which their more than a threefold reduction in risk-adjusted
services are held accountable to the public, in-hospital mortality [19]. The results, however,
accreditation and/or regulation models provide were not as favorable toward accreditation in a
the means of ensuring the correct environment study that examined the impact of accreditation
for clinical practice has developed into a form of in ambulatory surgical centers (ASC) suggesting
public regulation [17]. In brief, the regulatory no systematic differences in the quality of care
model is driven by the government in which stan- between ASCs that were accredited or and those
dards are set and the inspection of health care that were not accredited. This aligns with the
organizations within these standards produce most comprehensive meta-analysis of accredita-
verification for continued operation, often a con- tion and certification studies and which demon-
dition for receiving public funding. Accreditation strated little to no evidence supporting any lasting
is often characterized by a model driven by self- positive outcomes of these efforts given the way
regulation or voluntary participation, where the accreditation is presently conducted [21].
compliance of standards are both defined and In light of the limited evidence comparing the
assessed by an independent body [18]. This safety and outcomes of accredited and non-
external validation of standards in safe practices accredited surgical centers, a very important
can provide the patient and relevant stakeholders contribution to accreditation is the process of
with information about surgical center’s commit- assessment and regulation that allows for organi-
ment and progress toward quality improvement zations to understand the range of risks that are
and safety, with benchmarking performance present, their ability to control them, the probabil-
against other accredited facilities. An organiza- ity of occurrence and its potential impact—
tion’s motivation for accreditation can stem from Fig. 45.1. If risks are properly assessed and
a number of different areas, all of which are sub- managed then it stands to reason that, with appro-
ject to the model adopted. As a result, these local priate controls in place, the safety and quality of
standards and their oversight are highly dictated surgical outcomes can be increased. As surgical
by local country specific policies. centers are moving towards a greater emphasis on
establishing standards and requirements that miti-
gate and potentially eliminate risks to the patient,
Developing and Applying Surgical accreditation systems have the potential to address
Standards the reliability of this process. Fortes and col-
leagues [22] describe the development of accredi-
The growing interest in the development and tation as a tool “to evaluate the risks that occurred
application of standards for surgical centers is in the hospital environment, with the objective of
due to the presumption that accreditation may protecting the professional that worked at these
provide surgical centers the advantage of improv- units.” These good intentions, however, come
ing outcomes of surgical practices. However, with various challenges for accreditation survey-
given the only recent growth of regulation and ors related to implementing approaches that
Fig. 45.1 Enterprise Risk Management approach and its impacts on patients, families, providers, managers and society
accurately assure that the surgery center policies safety outcomes in capturing all the salient fea-
and procedures designed to aid clinical practice tures of surgical operation [24]. Vincent et al.
are reflected in safe patient outcomes and are [24] suggests including factors such as equip-
internalized by the providers doing the surgery. ment design and use, communication, team coor-
Specifically, the activities related to the assess- dination, human factors affecting individual
ment of surgical safety centers, which are often performance, and the working environment [25,
characterized as having dynamic and complex 26]. Others who have conducted and analyzed
infrastructures, can be a daunting process for over 100 surgical RCA point to the need to better
external accreditors. This is especially the case understand what the employees and staff feel is
when properly identifying the unique risks spe- important and relevant to the investigation [27].
cific to the center being assessed. This is mostly The broad competencies expected by assessors
due to a process that is dependent on the willing- can be difficult to achieve and presents a chal-
ness of the organization to report and disclose lenge in both recruiting and training surveyors,
past, current, and anticipatory errors. Unfor and in providing an objective evaluation by third
tunately, the culture of fear of punishment and party agencies.
litigation leads hospital personnel to avoid dis-
closing or to shading this information [23]. As a
result, in order to gain an accurate understanding Building Safety
of the center’s adherence and performance to Through Accreditation and Risk-
mitigating risk, the assessor must rely on a deep Thinking: Responsibility
knowledge of the domain, have the skills to tact- and Accountability
fully navigate the political challenges, using nim-
ble risk management approaches and tools. Researchers are identifying strategies in auditing
Assessors must additionally use their time and that ensure risks are being accurately assessed.
resources wisely to provide a wider assessment For a successful adaptation strategy, this demands
of the factors that may be relevant to surgical a more dynamic approach that focuses on the
s ystem as a whole by including all levels of the professional autonomy, merely a replacement of
organization from top leadership to workers at pure individual autonomy by more collective
the coal face [28]. Yet for decades, auditing and autonomy [31]. Results should be fed back to the
safety improvements have been driven by the ret- pathway owners, whose task is to continuously
rospective review of incident reports, errors, and improve the performance and thus the quality of
violations. The problem with these approaches is care. Information technology (IT) plays a vital
that they mean a negative event has already role in measuring outcomes and improving pro-
occurred. A more proactive approach is to assess cesses. However, some of the most impressive
the likelihood and consequence of something breakthroughs have occurred in organizations
going wrong within a process and the system in where the IT infrastructure was still unsophisti-
which it takes place and to put in place controls cated, so technological limitations are no reason
to prevent or mitigate the negative event [29]. for inactivity [32].
Such a risk-based approach underpins the nature
of accreditation.
Designated individuals should be responsible Culture Devoted to Quality
A
for the clinical and financial outcome of patient and Reliability
pathways and accountable to senior management.
All information should be distilled as it flows Health care can be thought of as hypercomplex,
upwards, to keep leaders informed but not over- involving interacting processes, systems and peo-
whelmed with data, with appropriate levels of ple (Table 45.2). Risk based approaches offer a
detail for each audience. In some of the best exam- way to tackle the way in which people and socio-
environmental factors interact. Risk thinking
ples, quality and safety are built into the strategic
goals and become a central part of all board meet- encompasses cyclical, continuous and dynamic
ings, supported by robust internal audits to verify processes of assessing hazards and selecting,
the established high standards of governance, as implementing and evaluating controls to reduce
the potential of those hazards from becoming
with financial audits, are consistently applied [30].
harm [33]. It offers a means to create safer, high
quality care by addressing in structured, scientific
Optimizing and Standardizing ways human, technical and organizational issues,
Clinical and Organizational Processes i.e. the nexus of factors and circumstances where
preventable harm most often arises [8]. In doing
Doctors have typically been deeply resistant to so, it supports the spread and sustainability of
standardization, believing that every patient is good practice, by enabling people to understand
unique. However, such an individual-by- their local context; the nature of any innovation;
individual approach actually increases the likeli- and its planned cause and effect (including fore-
hood of errors. Leading providers have achieved seeable positives and negatives).
dramatic results by implementing standard Learning from other high risk sectors supports
guidelines and operating procedures, increasing this [34]. Responding to major disasters such as
patient survival rates and cutting the cost of care Flixborough and Piper Alpha [35], other sectors
significantly. The path to standardization can, have made great strides in improving safety at a
however, be slow and painful, with staff at all system level by using risk based approaches [36].
levels reluctant to change behavior, resulting in a They have been able to think ahead about what
frustrating lack of compliance. Clinical leaders the obstacles and hazards might be; how those
must be relentlessly vigilant in checking and obstacles and hazards might prevent improve-
double-checking adherence to protocol, making ments or become harmful outcomes; and how
those on the front line directly accountable and systems can then best be designed to prevent or
stressing that guideline adherence is not a loss of mitigate unintended results [34].
Table 45.2 Dimensions and attributes of the hyper complex nature of health care
Dimensions Attributes
Vulnerability and involvement • Unwell, fearful, impaired communication
of “end user” • Variable knowledge—information asymmetry and vulnerability to quackery
and fraudulent information
• End user is also a component but non-standardized (genetics, social
circumstances, choices = life course)
• Most processing is “off plant”
Leadership and culture • High degree of professional autonomy and power
• Silo working with emphasis on specialization
• Ambiguous and ambivalent relationship to management
• Poor history of safety education and culture—implicit rather than explicit
Highly politicized • Constant wholesale change
• Evolution rather than system design
• Conflicting goals
• Regulatory tensions—centralism vs. localism
• Ideological toy
• Almost daily media coverage
Activity patterns • Large numbers
• Difficult to impossible to shut down
• Lots of predictability but episodes of uncertainty (new diseases, major
incidents)—not just emergencies but immediate sustained changing needs
Technical/competence • Differentiated workforce with varying education and competence—from no
post-compulsory education to post-doctoral
• Research to practice gap—information overload and varying competence in
critique and application
• Tendency towards pseudo-invention and pseudo-understanding
• Guidance/guideline multiplicity and (in)coherency
• Diversity of providers and equipment—lack of standardization and
evolutionary introduction/adoption
Geography • System orbiting and overlap in patient pathways
• Patient movement within and across systems and organizations (primary,
secondary, tertiary health care; social care; voluntary sector)
• Regulation behind the curve—often different for primary, secondary, tertiary
health care; social care; voluntary sector—reflected by being “under” different
government departments
Accreditation provides a framework for Table 45.3 Iterative best practices in risk management
o rganizations to put risk thinking into practice Step 1: Map processes (including how processes
and address the hypercomplexity of health care. connect within and between organizations)
It is a program of activity in which trained exter- Step 2: Identify and assess risks to human,
nal peer reviewers evaluate an organization’s technological and organizational safety and
performance
compliance with preestablished standards [37,
Step 3: Establish prevention and mitigation controls
38], that can be applied to specific areas (such as to deliver safe and reliable results
managing infection risk or wrong site surgery Step 4: Continuously monitor to evaluate the efficacy
[39]) or across an organization’s services. The of those controls
iterative processes build on risk thinking by help-
ing an organization to drive best practices in risk Baldrige Model [13]—Fig. 45.2. By supporting
management (Table 45.3). organizations to identify, prioritize, and manage
The risk thinking inherent in accreditation risks accreditation tackles the key dimensions of
supports wider models of improvement, such as the quality.
Fig. 45.2 Risk-based thinking underpinning accreditation and other quality improvement models, such as the Malcolm
Baldrige National Quality Award
rong-Site Surgery: A Dynamic Risk

W changes. Prevention of WSPEs requires new and
Management Model innovative technologies, reporting of case occur-
rence, and learning from successful safety initia-
One way to bring accreditation to life is to use an tives (such as in transfusion medicine and other
example of how the risk thinking that underpins high-risk nonmedical industries), while reducing
it can be applied to practice. The problem of the shame associated with these events.
wrong-site surgery is a useful illustration. Wrong- Organizations that want to deliver highly
site surgery includes operations performed on the reliable and patient centered outcomes based
wrong side or site of the body, the wrong proce- around the model in Fig. 45.3 can assure regula-
dure performed, and surgery performed on the tors and accreditors that they are managing their
wrong patient [40]. Wrong-site surgery is classi- risks, constantly vigilant at what could go
fied as a never-event [13] because it is both pre- wrong, assessing the likelihood and conse-
ventable and can be devastating for patients and quences, and developing robust yet proportional
professionals alike. controls at each stage of the surgical patient
Wrong-side/wrong-site, wrong-procedure, and pathway [44].
wrong-patient adverse (WSPE) events, although
rare, are more common than health care provid-
ers and patients appreciate [41]. Wrong-site sur- earning from Experience:
L
gery is associated with failures in communication The Accreditation Process and How
(70 percent), procedural noncompliance (64 per- to Ensure Effective Implementation
cent), and leadership (46 percent) [42]. Other
system and process causes are listed in Table 45.4. Accreditation programs vary extensively as do
Risk factors associated with wrong-site surgery the organizations that carry out accreditation vis-
are emergency cases, multiple surgeons, multiple its. There is however one constant across all
procedures, obesity, deformities, time pressures, accreditation programs and that is the need for
and unusual equipment or setup, and room organizations to undertake a deep and authentic
Table 45.4 Causes of wrong-site surgery [43]

System factors Process factors
• Lack of institutional controls/formal system to verify • Inadequate patient assessment
the correct site of surgery • Inadequate care planning
• Lack of a checklist to make sure every check was • Inadequate medical record review
performed • Miscommunication among members of the
• Exclusion of certain surgical team members surgical team and the patient
• Reliance solely on the surgeon for determining the • More than one surgeon involved in the procedure
correct surgical site • Multiple procedures on multiple parts of a patient
• Unusual time pressures (e.g., unplanned emergencies performed during a single operation
or large volume of procedures) • Failure to include the patient and family or
• Pressures to reduce preoperative preparation time significant others when identifying the correct site
• Procedures requiring unusual equipment or patient • Failure to mark or clearly mark the correct
positioning operation site
• Team competency and credentialing • Incomplete or inaccurate communication among
• Lack of complete information members of the surgical team
• Organizational culture • Noncompliance with procedures
• Orientation and training • Failure to recheck patient information before
• Staffing starting the operation
• Environmental safety/security
• Continuum of care
• Patient characteristics, such as obesity or unusual
anatomy, that require alterations in the usual
positioning of the patient
Fig. 45.3 Risk-based process mapping

reflection process to learn from their experiences. already required by law, professional guidelines,
By undergoing accreditation, organizations have etc. They serve rather as a framework within
multiple opportunities to learn from experience which organizations can guide, co-ordinate and
and influence positive change; the challenge implement their quality and safety improvement
is identifying these learning opportunities and activities. Unfortunately, in the years between
ensuring their effective implementation. initial and re-accreditation visits, many organiza-
Accreditation is not and should never be a tions focus on other priorities and let their atten-
one-off process that organizations only engage tion drift from the accreditation requirements. By
with in the run up to and during the actual accred- drifting from the accreditation program organiza-
itation visit. The evidence shows that these types tions also find that their quality and safety
of accreditation approaches rarely if ever lead improvement activities also drift and have highly
to lasting change in quality, outcomes or value variable outcomes.
[21]. Accreditation must be viewed as a contin- So how do organizations ensure continual
ual learning process taking place at every level buy-in to an accreditation program and use it as
of the organization and supported by the accredi- an on-going performance improvement tool?
tation journey. All accreditation programs have There are several key factors to be
two key stages: preparation and accreditation. considered:
The first covers the key actions that an organi-
zation should undertake before an accreditation 1. Selection of the right accreditation program is
visit—Table 45.5. crucial. Accrediting organizations must have
The second stage, the accreditation process a clear remit and that must be understood by
itself, varies from program to program, and nor- the organization being accredited. The accred-
mally includes the requirement for an on-site itation program itself should include a require-
visit. This will be followed by either an accredi- ment for self-assessment and on-site visits.
tation award or the need to implement improve- The length of these visits should be propor-
ment actions prior to accreditation being awarded. tional to the size of the organization to allow
Organizations that achieve accredited status may adequate time to understand the organiza-
then be required to undergo periodic visits prior tion’s processes. The accreditation program
to a full re-accreditation visit. The nature and must be cyclical and must be used to drive
timing of these visits again varies extensively continuous improvement and therefore the
between programs but all will require a full restructure and content of any program should
accreditation visit 2, 3 or even 4 years after the drive this.
initial visit. 2. Accreditation programs must allow for
A good accreditation program will not require improvement action to be taken when a prob-
an organization to develop systems that are not lem is identified. There is much merit in
having an improvement process to enable

Table 45.5 Actions to undertake prior to an accreditation organizations with identified problems the
visit opportunity to put into place improvement
Key actions: actions. The process should not end with the
• Understanding the accreditation program and production of the action plan but must involve
standards/requirements;
review of plan implementation and follow up
• Establishing governance arrangements for the
by the accreditation agency. Reports on
accreditation;
• Pulling together and briefing a team;
accreditation outcomes must be shared with
• Identifying what help is available from the staff and the organizations so that they have a
accreditation body; clear action plan to work from.
• Conducting a self-assessment; 3. The team sent to audit an organization must
• Producing an action plan with clear roles and have experience and deep domain knowledge
responsibilities; the organization’s field. They needs to under-
• Implementing the action plan and reviewing progress. stand how clinical teams work, how to assess
and capture optimal team performance actions. Any improvement work should be
designed around surgical microsystem system based on standard quality improvement meth-
properties [45, 46]. This will help to ensure odology such as “Plan, Do, Study, Act” to
understanding of the organization and buy-in ensure that improvement actions are embed-
from those that they are auditing. The provided within the organization [50].
sion of support in the form of education and
guidance is essential for organizations going
through accreditation. Accreditation pro- Does Accreditation
grams need to be conceptual with guidance on and Certification Make
practical implementation. a Difference?
4. Senior managers must however ensure that
the mark of success of any accreditation pro- Accreditation and certification have been pro-
gram is not merely the achievement of an posed as interventions to support patient safety
award, but the learning and improvement and high quality health care. Guidelines recom-
opportunities associated with accreditation. mend accreditation but are cautious about the
The way in which senior managers engage evidence, judged as inconclusive. The push for
with clinicians and hospital staff and promote accreditation continues despite sparse evidence
the accreditation program will have a direct to support its efficiency or effectiveness.
effect on the program and quality improve- Greenfield and Braithwaite identified the effects
ment. Without senior management buy in and of accreditation on promoting change and profes-
support it is unlikely that staff will wholly sional development, indicating that the effects
commit to, and engage with the process and were probably due to accreditation and certifica-
opportunities for improvement may be lost tion, but lacking firm evidence [51]. A systematic
[47]. Senior managers who react positively to review by Nicklin et al. [52] found several posi-
the accreditation process and proactively tive benefits of accreditation; however, the study
respond to improvement recommendations lacked rigor to support their conclusions. Shaw
will demonstrate to staff that accreditation can et al. [53] found evidence for positive effects
be used as a learning opportunity rather than between accreditation, certification and clinical
as a “stick to beat” the organization [48]. leadership, systems for patient safety and clinical
5. Authentic communication within organiza- review, but was fell short of endorsing accredita-
tions and the establishment of multidisci- tion, and concluded with recommending further
plinary teams, in which clinicians actively analysis to explore the association of accredita-
participate, are also essential. Clinicians may tion and certification with clinical outcomes.
be reluctant to participate in accreditation pro- Furthermore, Ho et al. [54] have demonstrated an
grams if the lack of transparency and their unintended negative impact on the learning envi-
lack of awareness of what the program is try- ronment of medical students and trainees, includ-
ing to achieve or if they have little or no input ing decreased clinical learning opportunities,
to the preparation process [49]. Gaining their increased non-clinical workload, and violation of
input to resultant quality improvement activi- professional integrity in preparation and during
ties will therefore be challenging. Nominating accreditation and certification.
clinical leads, developing communication A recent extensive meta-analysis literature
plans and sharing knowledge within teams review [21] uncovered three systematic reviews
will all help with learning. and one randomized controlled trial. The lone
6. Finally, it is vital that organizations set realis- study assessed the effects of accreditation on
tic expectations. Accreditation milestones and hospital outcomes and reported inconsistent
deliverables should be established at the outset results from one controlled study, the random-
and actively discussed and agreed upon. These ized trial from South Africa from 2003. The
should not impose unrealistic expectations on study [55], however, is weak scientifically, and
staff and should allow time for improvement does not address morbidity or patient safety
measures well enough to support any conclusions organization to take corrective actions prior to
across a wide range of safety systems examined. reassessment. It should not be seen as a one-off
The methodological challenges of measuring event or as an end in itself. Rather it is a continu-
the effects of accreditation/certification are incre ous process that provides a structure for organi-
ased by the complexity of the hospital organiza- zations to manage their risks, improve the quality
tions and their heterogeneous components. Lessons of their services and to realize the benefits out-
can be learned from non-controlled studies such as lined in Table 45.6. A health care organization
cross-sectional studies [56]. Comparison between can prepare for an accreditation visit be follow-
accredited and non-accredited hospitals yields ing the steps in Table 45.7. Ideally and learning
important information about potential differences from other high risk domains, healthcare accredi-
between these hospitals, but cannot provide infor- tation will be a continuous process of assessment
mation about the observed variations, and whether and learning akin to high reliable nuclear power,
the results are transferable to other settings. aviation and maritime industries [36, 59].
The review by Brubakk et al. [21] provides a
comprehensive overview of the effects of accred-
itation and/or certification of hospitals on quality Conclusions
and patient safety outcomes and concludes that
due to scant evidence, no conclusions could be Accreditation continues to grow internationally
reached to support its effectiveness. Accreditation despite inconclusive evidence to support its
programs require substantial financial and labor effectiveness. The surgical space, by nature, is a
investments, and distract health care teams from high-risk hypercomplex environment where haz-
their primary clinical goals. Accordingly further ards lurk around every corner and for every
research about the clinical impact of these pro- patient. Health care institutions continue to face
grams is needed, and it is important to weigh the challenges in providing safe patient care in
transactional opportunity and financial costs of increasingly complex and demanding technical,
accreditation against other financial investments organizational, and regulatory environments.
in quality improvement interventions. Real, sustainable change comes from the organi-
Before planning further studies to evaluate zations and hardworking staff that deliver care to
impact of accreditation and certification efforts, a patients. It is odd that something so important
more thorough and nuanced analysis of the and personal as health care does not have widely
available evidence about which components of
acknowledged or adopted “industry standards” of
accreditation/certification seem to be most effec- inspection, reporting, and improvement.
tive in enabling patient centered, high quality and Both high reliability theory and systems the-
safer outcomes should be performed [57]. These ory provide conceptual and practical frameworks
conclusions need to be considered given the impact for supporting accreditation driven approaches
of how accreditation is managed and executed, and towards delivering safe and reliable care.
the varied political, financial and organizational Although many ambiguities and conflicts arise
macro- and meso-health care constraints [58]. from the implementation of these theoretic con-
structs, they should guide the development
of work processes and stimulate innovation in
ow Best to Prepare
H designing ways to provide safe and effective care
for Accreditation Visit? within health care systems. Organizing surgical
care around the pursuit of safety and reliability as
Accreditation typically occurs over a 3-year an overarching priority is a professional obliga-
cycle—Fig. 45.4. During the accreditation asses tion for all members of the health care team. This
sment, assessors are looking for evidence of goal can be accomplished by organizing around
effective risk assessment and controls. Where and shaping a culture focused on reliable perfor-
these are absent or inadequate the assessors will mance but requires substantial investments in
identify them as non-conformities to enable the human capital.
Fig. 45.4 Virtuous and continuous accreditation cycle
Table 45.6 The benefits of accreditation for an organization

Positive impact Evidence
Improved organization and coordination ?????
More systematic management practice ????
Improved professional practice and compliance with expected standards of care ???
Compliance with QI mechanisms and achievement of other quality indicators ?
Perception amongst health professionals ?
Greenfield D, Braithwaite J. Health sector accreditation research: a systematic review. Int J Qual Health Care.
2008;20(3):172–83
HAS. What is the impact of hospital accreditation? International literature review. Saint-Denis La Plaine Cedex: HAS;
2011
Greenfield D, et al. (2012) The standard of healthcare accreditation standards: a review of empirical research underpin-
ning their development and impact. BMC Health Serv Res. 2012;12:329
Table 45.7 Steps to prepare for an accreditation visit
1. Form team (a) Designate responsibilities for ensuring that preparatory work is addressed and that all staff within the organization understand and own the accreditation process
2. Review previous survey (a) Ensure previous requirements/non-conformities have been addressed and action plans implemented
results where they exist
3. Complete a self- (a) Survey or interview key stakeholders (leadership/management staff, clinicians, support and ancillary staff, patients and carers, representatives from organizations that
assessment within units connect along care pathways)
and across the (b) Observe practice—use tracer methodologies to follow patients along pathways and processes to identify if appropriate controls are in place and working (Fig. 46.3)
organization
4. Identify areas for (a) Based on the self assessment identify and share strengths and weaknesses
improvement (b) In DNV GL’s Standards, areas for improvement are categorized as:
1. Non-conformities Category 1 (Major):
i. An absence of one or more required system elements or a situation which raises significant doubt that the services will meet specified requirements
ii. A group of category 2 non-conformities indicating inadequate implementation or effectiveness of the system relevant to a requirement of the standard
iii. A category 2 non-conformity that is persistent (or not corrected as agreed by the hospital) shall be up-graded to category 1
iv. A situation that on the basis of available objective evidence may directly lead to unacceptable risk of patient harm or does not meet minimum standards of care
2. Non-conformities Category 2 (Minor):
i. The hospital has a lapse of either discipline or control during the implementation of system/procedural requirements but which does not indicate a system
breakdown or raise doubt that services will meet requirements
3. Observations:
i. An observation is not a non-conformity, but something that could lead to a non-conformity if allowed to continue uncorrected
4. Opportunities for improvement:
i. An opportunity for improvement relates to areas and/or processes of the hospital which may meet the minimum requirements for accreditation but which could be
improved to reach best practice
5. Develop action plans (a) Engage stakeholders for each area of improvement and create a specific, measurable, achievable, relevant and time-bounded action plan that should address:
to address areas for 1. What needs to be changed
improvement 2. Why
3. How it will be changed (the steps to be taken)
4. Who will be responsible
5. When the change should be completed
6. The measures that will be used to show that the change has been implemented, is having the desired effect (or not) and that the change can be sustained over time
6. Implement action plans (a) Use the Plan, Do, Study, Act cycle of improvement to implement, revise and sustain change
to deliver necessary
improvements
779
(continued)
780
7. Prepare for the site (a) Keep in mind that the value of accreditation is in helping your organization to improve by providing an independent, structured, constructively critical review of your
visit by the accreditation pathways and processes. It will only deliver this value if you and the staff within your organization are committed to accreditation as a learning opportunity and are
audit team honest with the accrediting body as to your strengths and weaknesses. To this end, organizations should have in place mechanisms to ensure that staff and service users
are able to share openly their experiences of what works and what does not.
(b) The emphasis of the accreditation visit will be on observing practice in real-time—how patients are treated and processes put into practice. To support this, the auditors
will need access to supporting documentation that shows how the hospital is organized, how care is delivered and how care ought to be delivered according to the
hospital’s own polices and procedures. You should typically expect to provide the audit team with:
1. Organizational charts for the organization as a whole and broken down by service areas
2. A map showing the locations of patient care and treatment and other services
3. A list of current in-patients with room number, age, diagnosis, attending physician, primary nurse, admission date and any other significant information
4. Patient census for the last 12 months including patient acuity/case mix
5. Current surgical schedule where applicable
6. Most recent accreditation and/or ISO certification where applicable
7. Bylaws of the Governing Body
8. Minutes of the Government Body
9. Medical staffing bylaws, rules and regulations
10. Minutes of the Medical Executive Committee
11. Organizational plan for patient care/scope of service for each department and patient care unit
12. Terms of reference for the Quality Oversight/Management Review Committee
13. Minutes of the Quality Oversight/Management Review Committee—including performance improvement data for the last 12 months, complaints data for the last 12
months (showing complaints received and response), incident data for the last 12 months (showing incidents reported and response), root cause analysis for the last 12
months
14. Minutes from Environment of Care/Safety Committee
15. Risk management policy and procedures
16. Risk assessment—organizational wide and unit specific as applicable including risk management plan
17. Management plans for the physical environment and annual evaluations
18. List of contracted services, companies and individuals—surveyors will select a sample for review
19. List of other organizations with whom you share care for patients (including organizations that refer patients and accept patients on discharge)—surveyors will select a
sample to contact for feedback
20. Nursing service plan of administrative authority/delineation of responsibilities for delivery of patient care
21. Infection Control Plan with risk assessment/hazard vulnerability analysis
22. List of employees including name, title, unit, and hire date
23. Skill mix of staff
24. List of current patients who have had restraint (chemical or physical) or seclusion used during hospitalization
25. List of patients discharged with the past 6 months who had restraint (chemical or physical) or seclusion used violent or self-destructive behavior during their
hospitalization
26. Policies and Procedures, typically including but not necessarily limited to:
i. Autopsies
ii. Blood and Blood Product Administration
iii. History and Physical Examination
iv. Informed Consent
v. Medication Security
vi. Moderate Sedation
S. Leyshon et al.
8. Site visit by audit team vii. Patient Assessment (Nursing, respiratory, nutritional services, etc.)
viii. Pain Management
ix. Patient Care Planning/Interdisciplinary Treatment Plan
x. Patient Grievance
xi. Procedural Verification Process (Practices ensuring the correct patient, site & procedure)
xii. Restraint or Seclusion
xiii. Verbal/Telephone Orders
(a) The audit team will focus on reviewing how care and other processes are delivered in real-time. To do this, you will need to:
1. Receive the audit team and show them around the premises
2. Provide the audit team with a dedicated room that they can use for the duration of their visit
3. Present a summary of your services and be prepared to answer questions on recent, current and foreseen threats to quality
4. Provide the audit team with access to the resources outlined in step 7 as well as access to patient records to enable them to use the tracer methodology in following
patients through their care pathways
5. Provide the audit team with access to staff and, through clinical staff, access to patients and their families to interview and follow
6. Provide the audit team with access to telephone numbers and contact details so that they can follow-up with contractors, partner organizations and former patients and
their families
9. After the site visit (a) Review the audit report, which will outline the findings including whether or not the organization has reached the necessary standard for accreditation or if corrective
actions are needed before additional assessment
(b) Where a corrective action plan is needed your organization will typically have 30 days from receipt of the audit report to submit their action plan to the accrediting body
for review
(c) The corrective action plan should address:
1. Each of the specific unmet elements in turn
2. A full explanation of the actions take to address the unmet elements
3. When the actions were completed
4. The impact of the actions including how they will be maintained
5. Measurement criteria and methods that are in place to monitor the elements
(d) Moving forward, your organization should use the standards you are assessed against as a way to make risk management and quality improvement a continuous process.
The standards reflect best practice in health care quality and patient safety and should be part of every employees day to day work—incorporated into their unit and
personal objectives
781
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The Perioperative Surgical Home:
The New Frontier 46
Juhan Paiste, Daniel I. Chu, and Thomas R. Vetter
“First comes thought; then organization of that thought, into ideas and plans; then
transformation of those plans into reality. The beginning, as you will observe, is in your
imagination.”
—Napoleon Hill, 1883–1970
Introduction (3) reducing per capita costs of health care [3, 4].
The Perioperative Surgical Home, using rigorous
The Perioperative Surgical Home has been standardization and integration of care, can
promoted as a novel, clinician-championed yet achieve the IHI Triple Aim for the surgical popu-
institution-
supported, well-coordinated and very lation, by optimizing quality, safety, and satisfac-
patient-centered, interdisciplinary model of care. tion while decreasing costs—thereby adding
The highly collaborative Perioperative Surgical measurable value to the highest cost segment of
Home more consistently and effectively guides the health care [5].
patient through the entire surgical continuum, from Because of its intentionally broad initial defi-
the initial decision to undergo surgery to the post- nition, and its equally broad array of stakeholders,
hospital discharge and rehabilitation phase [1, 2]. there will undoubtedly be multiple effective vari-
Berwick, Nolan, and Whittington, along with ants of the Perioperative Surgical Home, based
the Institute for Healthcare Improvement (IHI), upon institutional infrastructure and resources, as
have promulgated the “Triple Aim” of health care well as internal and external economic and politi-
reform, which is comprised of three interdependent cal forces [6]. The Perioperative Surgical Home
goals: (1) improving the individual experience of can also be conceptualized as an umbrella, under
care, (2) improving the health of populations, and which its variants or components are positioned.
These include service line or procedure-specific
integrated care pathways, Enhanced Recovery
J. Paiste, MD, MBA
Anesthesiology and Perioperative Medicine, After Surgery protocols (see Chap. 23), and
University of Alabama at Birmingham, Perioperative Risk Optimization and Planning
JT 845, 619 19th Street South, Birmingham, Tools (Fig. 46.1).
AL 35249, USA
Integrated care pathways are rigorously stan-
dardized, task-orientated care plans that detail all
D.I. Chu, MD
the essential steps or elements in the care of all
Department of Surgery, University of Alabama at
Birmingham, 1720 2nd Avenue South, KB427, patients undergoing a specific surgical procedure
Birmingham, AL 35294, USA [7]. Integrated care pathways (for coronary artery
e-mail: [email protected] bypass graft surgery, chest pain, etc.) link
T.R. Vetter, MD, MPH (*) evidence to practice to optimize clinical outcomes
Anesthesiology and Perioperative Medicine, while maximizing clinical efficiency [8, 9].
University of Alabama at Birmingham,
Enhanced Recovery After Surgery (ERAS®) is
JT 862, 619 19th Street South, Birmingham,
AL 35249, USA an evidence-based, fast-track approach to surgery
e-mail: [email protected] (e.g., colorectal), which relies upon perioperative

786 J. Paiste et al.
cost sharing, whereby patients are encouraged to

use providers, health care services and delivery
systems, and medications, which offer better
value than other available options [17].
The chapter first frames the Perioperative
Surgical Home as a value-based proposition.
After providing a definition and an inventory of
the drivers of health care value, specifically in the
USA as a representative developed country, this
discussion focuses on the fundamental determi-
nants of value, namely, appropriate care and
Fig. 46.1 The Perioperative Surgical Home conceptual-
quality, safety, satisfaction, and cost. It concludes
ized as an umbrella, under which its variants or compo- with a brief review of the literature supporting
nents are positioned the effectiveness and implementation of a
Perioperative Surgical Home model [18].
care protocols designed to attenuate the stress
response during the entire perioperative period,
so as to facilitate the maintenance of bodily com- he Perioperative Surgical Home
T
position and organ function, and in doing so to as a Value-Based Proposition
achieve early recovery [10–12].
A Perioperative Risk Optimization and Expanded health insurance coverage under the
Planning Tool (PROMPT™) amalgamates the 2010 Patient Protection and Affordable Care Act,
evolving published evidence with equally valued more robust economic growth, and an aging popu-
local clinicians’ expertise, to arrive at consensus, lation (the “Silver Tsunami”) are expected to result
thereby increasing the applicability and accep- in a continued greater demand for health care
tance of the resulting condition-specific, decision goods and services in the USA. Thus by 2023, a
support tool [5]. A PROMPT™ is not a static projected 19.3 % of the USA gross domestic prod-
document but instead is subject to an iterative uct will be spent on health care [19]. Furthermore,
series of Plan-Do-Study-Act (PDSA) cycles, surgical care currently accounts for an estimated
which incorporate newly published evidence, 52 % of hospital admission expenses in the USA
concurrent institutional-level outcomes data, and [20]. Fragmentation and inefficiency in surgical
continued local clinician innovations and feed- care delivery, defensive medicine, discordant
back [5, 13, 14]. incentives between stakeholders who deliver ver-
Globally, increasing health care costs are con- sus those who pay for this care, and a lack of
suming a larger and disproportionate share of emphasis on value are contributing to excessive
national budgets [15]. This has resulted in strate- surgical harm and expenditures [21, 22].
gies being implemented to control health care Leading health economist, Michael Porter,
delivery costs, through the more efficient use of has asked the fundamental question, “What is
health care resources, not only in the USA but value in health care?”—defined it as the ratio
also in Canada, England, France, and Germany of health outcomes achieved per dollar spent
[15]. In England, recent reductions in health care [23, 24]. However, Porter observed that value
expenditure (i.e., budget cuts) have also included in health care remains largely unmeasured and
decreasing the rate of certain surgical procedures, misunderstood, partly because its “stakehold-
deemed to be ineffective, overused, or inappro- ers have myriad, often conflicting goals,
priate [16]. Efforts are likewise underway in the including access to services, profitability, high
USA and several other member countries of the quality, cost containment, safety, convenience,
Organization for Economic Cooperation and patient-centeredness, and satisfaction” [23].
Development (OECD) to implement value-based Therefore, despite the current contentious
46 The Perioperative Surgical Home: The New Frontier 787
health care environment, all stakeholders must tive health care value is the Bundled Payment
embrace a value-based framework, given its Initiative for Care Improvement (BPCI) [13].
unifying primary goal of improving outcomes The BPCI has been introduced by the Centers
while doing so as efficiently as possible [25]. for Medicare and Medicaid Services (CMS) to
Like the Patient-Centered Medical Home [26], break existing health care system silos down
upon which it was patterned [2], the Perioperative and to improve patient care through innovated
Surgical Home essentially seeks “to improve value payment models that promote coordination of
for patients, where value is [specifically] defined as care and quality through a more patient-centered
patient outcomes achieved relative to the amount approach [31, 32]. Under the initiative, organi-
of money spent” [27]. This basic quotient translates zations enter into payment arrangements that
into a health care value equation (Fig. 46.2) that is include financial and performance accountabil-
applicable to the Perioperative Surgical Home, ity for episodes of care.
whose numerator includes perioperative quality, In Model 4 (final phase of its BPCI), “CMS
safety, and satisfaction and whose denominator is makes a single, prospectively determined bun-
the total costs of perioperative care [13]. dled payment to the hospital that encompasses all
Rather than continuing to reward the volume services furnished by the hospital, physicians,
regardless of quality of care delivered, the goal of and other practitioners during the episode of care,
the Department of Health and Human Services is to which lasts the entire inpatient stay. Physicians
increase the proportion of Medicare value-based and other practitioners submit “no-pay” claims to
purchasing from 30 % by the end of 2016 and to Medicare and are paid by the hospital out of the
50 % by the end 2018 [28, 29]. The Health Care bundled payment” [32, 33]. On April 1st, 2016
Transformation Task Force, a new coalition of the CMS started the Comprehensive Care for Joint
country’s largest health care systems and commer- Replacement (CJR) model, which will hold hos-
cial insurers, is similarly committed to transitioning pitals accountable for the quality of care they
the way providers and hospitals are paid from the deliver to Medicare fee-for-service beneficiaries
traditional volume-based, fee-for-service contracts for hip and knee replacements. Through this pay-
to one predominately linked to the patient centered ment model, hospitals in 67 geographic areas will
value of care. This task force is committed to shift- receive additional payments if quality and spend-
ing 75 % of non-governmental health care payments ing performance are strong or, if not, potentially
to value-based arrangements by 2020 [30]. have to repay Medicare for a portion of the
There are a number of drivers of health care spending for care surrounding a lower extremity
value, which collectively represent a “burning joint replacement procedure.
platform” that will necessitate a fundamental The Perioperative Surgical Home care model
change—a “New Frontier”—in perioperative can respond successfully to such bundled payments
care delivery and payment models in the USA, where historically, hospitals, surgeons and other
all being closely watched by many health care physicians, and post-acute care providers have
systems internationally (Fig. 46.3) [13]. Likely been paid separately for services occurring during
the most pressing of these drivers of periopera- and after hospital admissions.
Fig. 46.2 The health care

value equation applicable to
the Perioperative Surgical
Home
Fig. 46.3 The drivers of health care value necessitating a fundamental change—a “New Frontier”—in perioperative
care delivery and payment models in the USA
Quality Many of the continued challenges in achiev-

ing high quality care arise from the underuse,
Quality in health care describes the extent to which misuse, and overuse of health services, including
health services provided to individual patients and surgery [37, 38]. Variations in these practice pat-
patient populations improve desired health out- terns can lead to undesired measures of quality,
comes and are consistent with the current body of including increased mortality, morbidities,
knowledge [34]. In 2001, the Institute of Medicine lengths-of-stay, readmissions, and cost [39, 40].
(IOM) defined quality health care as “safe, effec- Modern efforts in quality improvement (QI)
tive, patient-centered, timely, efficient and equita- focus on minimizing variations in care by using
ble” [35]. The Agency for Healthcare Research and best-available evidence to standardize care path-
Quality (AHRQ) defined quality simply “as doing ways for patients. Successful results from stan-
the right thing for the right patient, at the right time, dardizations of care have been repeatedly
in the right way to achieve the best possible results” demonstrated in disciplines ranging from cancer
[36]. While significant strides in quality have been care [41] and geriatrics [42] to obstetrics [43] and
made in the last century, “doing the right thing” is outpatient ambulatory medicine [44]. Surgical
no longer expected to just improve traditional met- patients are particularly amenable to QI efforts as
rics, such as mortality, but to also improve patient- these patients require complex care in a surgical
centered metrics such as health-related quality of microsystem defined by multiple providers in
life and patient-reported outcomes. These new chal- varying environments, and attendant quality met-
lenges of the modern era necessitate more resource- rics are readily measurable [45]. A deliberate
ful approaches for continued improvement in health method in standardizing the continuum of care
care. As a more comprehensive yet integrated, for the surgical population and reliably measur-
value-based, and patient- centered model, the ing its outcomes has the potential to achieve sig-
Perioperative Surgical Home is anticipated to nificant, far-reaching gains in quality of care and
provide a modern framework to achieve these goals. health outcomes [46].
The Perioperative Surgical Home aims to Importantly, this engagement provides a unique
improve quality by standardizing patient care in and meaningful opportunity for stakeholders to
every phase of the perioperative continuum. While address other top priority issues in health care such
the Perioperative Surgical Home is a relatively as health-related disparities and patient safety.
new concept and direct practical examples are lim- Disparities, as an example, are caused by a conflu-
ited, evidence from the Patient-Centered Medical ence of patient, provider, and systemic factors [56]
Home [47] and Enhanced Recovery After Surgery and the ability to detect, understand and reduce
(ERAS) pathways [48, 49] demonstrate that stan- health-related disparities requires a comprehen-
dardization of care can positively impact quality sive approach. Factors such as poor health literacy
with significant reductions in length-of-stay, read- and inconsistent patient–provider communication
missions, morbidities, and cost. Standardization [57] contribute to disparities and could be better
studies have also demonstrated significant gains in targeted with more patient-centered, standardized
less-traditional, but equally if not more important, delivery of care as championed by the Perioperative
quality metrics including short-term quality-of- Surgical Home. While future studies will begin
life [50], reduced patient readmission [51] and validating its positive effects on traditional quality
other health-related quality measures [52]. These metrics, the Perioperative Surgical Home is posi-
studies suggest that high-quality care in the mod- tioned to make its most groundbreaking impact on
ern era is best achieved not by the lone practitioner adjoining, quality-associated frontiers such as
at a single patient encounter but by a cross-disci- health-
related disparities and patient–provider
plinary, collaborative, and consistent delivery of communication.
care by all stakeholders across the entire patient
experience [53].
The development and implementation of the Patient Safety
Perioperative Surgical Home is gaining momen-
tum, and studies of individual elements of the Patient safety is the foundation upon which quality
Perioperative Surgical Home show promising care is based [35], and both concepts are inextrica-
results in supporting their effectiveness in improv- bly linked when building a trustworthy health care
ing many measures of quality [54]. The organiza- delivery system. While the definition of patient
tion of these elements under one comprehensive safety is constantly evolving, the World Health
system produces a powerful construct that may Organization (WHO) defines patient safety as the
gain more in quality than any one component by “prevention of errors and adverse effects to patients
itself. Recently, the Perioperative Surgical Home associated with health care” [58]. The Institute of
has been successfully implemented in the Veteran Medicine (IOM) considers patient safety “indistin-
Health Administration (VHA) with positive, col- guishable from the delivery of quality health care”
laborative effects on health care delivery at a single [59]. Effecting changes in quality therefore has
institution [55]. These results parallel the well-rec- repercussions on patient safety. The Perioperative
ognized effects of the Patient-Centered Medical Surgical Home aims to provide not only the highest
Home on quality improvement in both patient and quality of care but also the greatest level of patient
provider-centered measures of quality [47]. safety by comprehensively standardizing perioper-
While the definitions and measures of quality ative processes based on the best clinical care and
will undoubtedly continue to grow, the Perioperative safety practices.
Surgical Home appears well-positioned to facili- Improving patient safety is an international pri-
tate patient engagement through preoperative risk ority. The landmark 1999 IOM report “To Err is
optimization of chronic diseases management, Human” estimated that as many as 98,000 people
patient education and post-acute care coordina- die every year from preventable medical errors
tion—all anticipated to improve outcomes and that occur in hospitals [60]. These examples
overall quality of care. include wrong-site surgeries, hospital- acquired
infections, and adverse drug events [61]. The 1999 health care structures and processes, which is a
IOM report sparked a remarkable series of events, principle goal of the Perioperative Surgical Home,
including Senate bill 580 (Healthcare Research may therefore provide the greatest gain in patient
and Quality Act of 1999) that renamed the Agency safety and related quality.
for Health Care Policy and Research to the Agency As the discipline of safety science continues to
for Healthcare Research and Quality (AHRQ). In evolve, our ability to identify, understand and
2004, the Institute for Healthcare Improvement reduce harm necessitates innovative strategies
(IHI) implemented the “100,000 Lives Campaign” [69]. The Perioperative Surgical Home provides
with the goal of saving 100,000 lives by challeng- the platform to engage and target key determi-
ing hospitals to improve health care quality and nants of patient safety at all points of care from
patient safety through six goals: develop rapid the preoperative assessment to the postoperative
response teams, provide evidence-based care for debriefing and hospital stay. The Perioperative
acute myocardial infarctions, prevent adverse drug Surgical Home is furthermore aligned with the
events, administer appropriate perioperative anti- central tenet of patient safety which posits that
biotics, and use central line and ventilator bundles systemic change is far more productive in reduc-
[62]. While this campaign succeeded in catalyzing ing medical harm than targeting individuals.
institutions to focus on patient safety, significant Exacting these changes in the perioperative con-
variations in institutional effort and heterogeneous tinuum alters habits and expectations for all stake-
results suggested that there was a need for more holders, from patients to providers, and allows the
comprehensive, reproducible, and effective safety Perioperative Surgical Home to change not only
strategies that targeted how best to implement our perspective towards safety but also the culture
these solutions while addressing the barriers to in providing the safest and reliable care for all sur-
uptake and behavior change. gical patients.
The complex nature of modern health care
invites errors to occur, and efforts to mitigate these
risks require innovative approaches. The 2007 Patient Satisfaction
Joint Commission’s Annual Report on Quality and
Safety identified significant determinants of errors Patient satisfaction has garnered greater attention
and reported that inadequate communication was as a metric of health care provider performance
the most common root cause of sentinel events and an important dimension of value-based health
from 1995 to 2005 [63]. Additional causes of med- care. While defined in a number of ways, patient
ical errors included inadequacies in patient assess- satisfaction is now publicly reported to help
ments, organizational culture, care planning, patients choose more discernibly among available
continuum of care, and training. Few would refute providers [13, 70].
that better communication and coordination of There are numerous demonstrated benefits to
care can improve patient safety and resultant keeping patients satisfied [71]. Satisfied patients
health outcomes. While the direct effects of the are more likely to adhere to prescribed treat-
Perioperative Surgical Home on patient safety ment plans, to maintain an ongoing relationship
have yet to be fully validated or realized, studies with a health care provider, and to realize subse-
have consistently demonstrated that standardiza- quent benefits related to health care outcomes
tion of care, from patient hand-offs [64] and pre- [72]. Providers’ interests are also well served by
operative surgical checklists [65] to insulin satisfied patients, as they may realize increased
regimens [66, 67], leads to higher levels of patient patient volume, an enhanced community reputa-
safety [68]. Models like ERAS and the Patient- tion, reduced malpractice claims, more satisfied
Centered Medical Home have also suggested that staff, decreased staff turnover, and improved
the delivery of consistent care and communication efficiency [72].
across the entire care continuum improves both Patient satisfaction is widely recognized to be
safety and quality [47–49]. Reducing variability in multidimensional and highly personalized, but at
its core is based upon delivering patient-centered The Perioperative Surgical Home seeks to
care [73]. Research shows that how patients per- improve patient satisfaction, by promoting shared
ceive their health care experience reflects socio- decision-making, earlier and greater engagement in
demographic characteristics, such as education patient education and preoperative optimization,
level, age, race/ethnicity, income, and health status standardized and thus likely better pain and postop-
[74]. Studies have observed that patients with erative nausea/vomiting management, shortened
younger age, better health, higher income, and stay in hospital and ultimately, improved outcomes
greater education tend to be less satisfied as com- and experience with the total care episode [83].
pared to the older patients and those who are sicker From the surgeon’s prospective, the Perioperative
or have a lower socioeconomic status [75–77]. Surgical Home seeks to improve satisfaction by cre-
However, it is no longer enough for patients to be ating more efficient operating room scheduling and
merely satisfied with their health care [78]. Patients’ patient throughput. The sustained success of these
expectations and perceptions of their experience operational changes must be based upon data (e.g.,
may vary widely, but ultimately, they seek health key performance indicators) and preferably con-
care that is patient-centered and yields the out- firmed using “Six Sigma” or “Lean” methodolo-
comes that they value and thus expect most [79]. gies. Appropriate patient preoperative optimization
Although patient-centered care and patient decreases delays and cancellations on the day of
satisfaction have been the central focus, there has surgery, assuring that surgeons are able to use their
been inadequate attention paid to surgeon and operating room (OR) block time with maximum
other providers satisfaction [80]. It is well known efficiency. Finally, patients satisfied with their care
that surgical services (the operating rooms) drive are less likely to initiate malpractice claims and are
hospital financial performance. The contribution the best advocates to endorse their physicians [54].
margins per hour of OR time, although rather
variable, can reach up to $2500.00 [81, 82]. Due
to this significant financial impact, effective and Cost
efficient operating room utilization is paramount
not only to surgeons but to all stakeholders. The health care value equation for the Perioperative
The Perioperative Surgical Home supports Surgical Home cannot be defined without includ-
multispecialty teams that design and implement ing the costs associated with the optimal care in
patient-centered, data-driven, surgical service- the equation. The Healthcare Cost and Utilization
specific workflow processes, starting from when Project estimates that about 15 million hospital
the decision for surgery is made. These pro- stays each year involve an operating room (OR)
cesses include comprehensive preoperative procedure and these hospital stays are 2.5 times
patient preparation, intraoperative management, more expensive than admissions without an OR
and postoperative care. Surgical service-specific procedure [84]. The OR is a significant cost center
teams develop standardized care and workflow and revenue generator for the hospital. The major-
plans to address (a) all components of the preop- ity of costs associated with surgery are incurred
erative assessment and optimization; (b) all on the day of surgery. The economic definition of
intraoperative elements of the “day of surgery” cost is the value of opportunity forgone as a result
patient encounter and experience; and (c) all of engaging resources in an activity. From the
postoperative care, starting with minimizing health care providers’ prospective, there are four
postoperative nausea and vomiting and pain in basic reasons to measure costs: (a) to make eco-
post-anesthesia care unit (PACU) and ending nomic decisions for resource allocation; (b) as
with long-term plans for rehabilitation. justification for reimbursement; (c) to encourage
Standardized care plans are based on evidence- or discourage use of services; and, (d) for income
based-medicine, but take into consideration and asset measurement for external parties [85].
institutional and surgical procedure, and local However, the reality in health care is that mea-
surgical team-specific variations. surement of these economic variables has been
extraordinarily challenging and controversial. relationship between outcome and cost or, more
Lead health economists have observed, “an almost specifically, the health outcome per dollar
complete lack of understanding of how much it expended. Our existing Fee-For-Service and
costs to deliver patient care” [86]. DRG-based payment model does not focus on
From payers’ perspective, the “unit” of cost is value—and for that reason is arguably unsus-
the price paid for each unit of service multiplied tainable. The Perioperative Surgical Home can
by the frequency of services. The mix of services, offer significant cost reductions by improving
and the variation in price per unit paid to different care coordination, minimizing unnecessary
providers, makes it difficult to assemble the rea- testing, consistently applying standardized best
sonable cost of providing care for an individual practice surgical and anesthesia care pathways,
plan member for a specific procedure. All above decreasing length of stay in the hospital and
makes it difficult for consumers, employers, and ultimately improving patient outcomes and sat-
health plans to understand and agree on the total isfaction with care [54].
price paid for an episode of care and to transpar-
ently compare that price paid from one provider
to another [87]. vidence to Support
E
Deming wrote that you can only improve a the Perioperative Surgical Home
process that you measure [88]. Information
enables decision-making and, ultimately, empow- In an effort to analyze the evolution of the ele-
ers change. However, with the paradigm shifting ments of the Perioperative Surgical Home and
from “fee for service” (FFS) and “Diagnoses- similar care models, in the USA and other coun-
Related Group” (DRG) to the “accountable care tries, researchers from Texas A&M University
organization” (ACO) model, hospital systems are and the American Society of Anesthesiologists
faced inevitably with major adjustments to their performed a comprehensive systematic review of
payment system. 152 studies published between 1980 and 2013
Hospital cost accounting software systems inte- [54]. They summarized the published findings
gration with multiple hospital information systems related to (a) clinical outcomes and (b) cost
has enabled a bottom-up cost method otherwise and efficiency, in a variety of preoperative,
known as Activity-Based Cost Accounting [85]. intraoperative, or postoperative settings. The

This method aims to establish the actual of specific studies predominantly reported positive quality
resources consumed to provide each service and is and cost outcomes across the perioperative con-
presently used to price surgical services by mea- tinuum (Table 46.1). These authors concluded:
suring expense at the patient care level and work- “The potential for … cost savings and quality
ing upward. Activity Based Costing (ABC) improvement is apparent across the perioperative
method maps all surgical procedure related activi- continuum of care, especially for integrated care
ties, calculates the cost associated with each activ- organizations, bundled payment, and value-based
ity and the unit cost for each procedure. Although purchasing” [54].
this approach appears to be the most accurate, it is It should be noted while the majority of these
still complex and requires tremendous resources 152 identified studies reported a significant
for implementation. As cost basis is the integral effect of a given perioperative intervention on a
component of any accountable care organization, measured outcome, one should not equate (a)
hospital administrators are recognizing the impor- such observed statistical significance with sub-
tance of correct and timely cost accounting prac- stantial association, (b) such observed simple
tices as a prerequisite to the institution financial association with definitive causation (causality),
success [89]. and (c) statistical precision (i.e., small P-values
Health care’s various stakeholders are on a and narrow confidence intervals) with scientific
quest to achieve value—which is defined as the validity [90].
Table 46.1 Summary of the results of a comprehensive systematic review of 152 perioperative care-related studies that
were published between 1980 and 2013 [41]
Significantly positive Significantly positive cost
clinical outcomes and efficiency
Phase of perioperative care Results were reported Results were reported
Preoperative initiatives 82 % 82 %
Intraoperative Initiatives 86 % 77 %
Postoperative Initiatives 87 % 75 %
I dentifying and Overcoming groups of highly engaged participants, in a con-

Barriers to Implementation trolled setting, seeking to secure demonstrable
“early wins [80].” Many of the possible strategies
The implementation of a PSH model will be pred- are derived from other business sectors and include
icated on successful, often large-scale change frameworks such as Knowledge-to-Action (KTA)
management [13]. We have noted at our institu- and Plan- Do-Check-Act (PDCA). The KTA
tion that an early implementation barrier can be a framework, in particular, has been used to success-
lack of engagement and buy-in necessary for the fully implement ERAS by McLeod et al. [93].
project’s success [91]. The perspectives of the key Using a “ground-up” approach, McLeod et al.
stakeholders—surgeons, anesthesiologist, nurs- [93] implemented ERAS in 15 provincial hospi-
ing, and hospital administration—are likely not tals and found that the path to success started
innately and initially aligned. Furthermore, criti- with the involvement of ground-level providers
cal but often initially limited resources are avail- from the very beginning of program development
able to collect and to report real-time data that (knowledge). Constant feedback and wide inclu-
demonstrate meaningful improvements in clinical sion of stakeholders from all disciplines during
outcomes, efficiency, safety, and patient satisfac- program rollout (action) ensured continued buy-
tion, thereby fostering greater buy-in and larger in and momentum in overcoming barriers.

scale education and implementation activities Implementation of PSH will likely face similar
[92]. Lastly, another prerequisite yet potential barriers at the patient, provider and hospital-level,
barrier for successful PSH implementation is but experience with ERAS suggests that with the
development of an institutional funding mecha- right people, these barriers are surmountable.
nism to compensate providers for the value-added
services rendered that will not be directly reim-
bursed by payers. Conclusions
Engagement of every stakeholder in the change
management process is paramount for success if Health care in the USA is rapidly evolving from
the above and other implementation barriers are to being a volume-based to a value-based proposi-
be overcome. ERAS pathways can represent one tion. There are a number of major drivers of
component of an institutional PSH model. Studies increased health care value, including for the sur-
of ERAS have identified many barriers to success- gical patient, which collectively represent a “burn-
ful implementation, including the above noted ing platform” that will necessitate a fundamental
resistance to change among personnel, time change—a “New Frontier”—in perioperative care
restrictions, limited hospital resources, lack of delivery and payment models in the USA. The
data, and organizational environment [93, 94]. highly collaborative Perioperative Surgical Home
Overcoming these barriers requires a coordinated, model represents a new approach to surgical
sustained and multipronged approach. This patient care, which can increase quality, safety and
includes starting the focused project with one or satisfaction, while decreasing costs, thereby maxi-
two physician champions, working with smaller mizing perioperative value for all stakeholders.
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Surgical Graduate Medical
Education Program Accreditation 47
and the Clinical Learning
Environment: Patient Safety
and Health Care Quality
John R. Potts III, Constance K. Haan,

and Kevin B. Weiss
“As to diseases, make a habit of two things — to help, or at least, to do no harm.”

—Hippocrates, Epidemics, 460 BC–377 BC
(AMA) [1]. In 2000, ACGME became an inde-

Introduction pendent organization. As of 2014–2015, ACGME
was accrediting 692 sponsoring institutions (SI)
The Accreditation Council for Graduate Medical and 9645 residency and fellowship programs,
Education (ACGME) was established in 1981 as who are training 121,599 residents and fellows
a “council” in the American Medical Association [2]. It is the largest private regulatory organiza-
tion over graduate medical education (GME) in
J.R. Potts III the USA.
Division of Accreditation Services, Accreditation Its mission is to “improve health care and
Council for Graduate Medical Education,
401 N. Michigan Avenue, Chicago, IL 60611, USA
population health by assessing and advancing
e-mail: [email protected] the quality of resident physicians’ education
C.K. Haan, MD, MS, MA
through accreditation.” [3].
Clinical Learning Environment Review (CLER) Its principle program is that of accredita-
Program, Accreditation Council for Graduate tion. However it also has a major education
Medical Education, 401 N. Michigan Avenue, program serving the GME community. More
recently it has established two new programs:
the GME resident milestones and the Clinical
K.B. Weiss, MD (*)
Division of Accreditation Services, Accreditation
Learning Environment Review Program
Council for Graduate Medical Education, (CLER).
401 N. Michigan Avenue, Chicago, IL 60611, USA The ACGME has increasingly emphasized
Clinical Learning Environment Review (CLER) patient safety and quality improvement in its
Program, Accreditation Council for Graduate requirements. This chapter reviews the main evolu-
Medical Education, 401 N. Michigan Avenue, tion of the ACGME standards in patient safety and
health care quality and presents an overview of the
Department of Medicine and Center for Healthcare CLER program. The focus of this chapter is how
Studies, Northwestern University Feinberg School of
Medicine, 633 St. Claire Street, Chicago, IL 60611, USA
these standards and the CLER program seek to
e-mail: [email protected] impact the quality of GME for surgical training.

800 J.R. Potts III et al.
atient Safety, Health Care Quality,

P AMA added specificity regarding quality assur-
and Accreditation of Surgical ance. “Institutions … must conduct formal qual-
Training ity-assurance programs and review complications
and deaths. All residents should receive instruc-
The ACGME sets it standards in three levels of tion in quality-assurance/performance improve-
detail. These include requirements specific to ment. [Residents] should participate in
each specialty and subspecialty, the requirements appropriate components of the institution’s per-
that are common to all residency and fellowship formance improvement program” [7]. In 2001,
training (Common Program Requirements), and the ACGME became independent of the
standards that are at the level of the institution AMA. Closely following that important structural
that sponsors one or more ACGME accredited change, the ACGME promulgated six “General
training programs (Institutional Requirements). Competencies” to be demonstrated by residents
(Table 47.1) [8].
Largely in response to concerns for patient
pecialty, Subspecialty, and Common
S safety, the ACGME implemented duty hour restric-
Program Requirements tions in all programs in 2003. These generally lim-
ited resident duty hours to 80 per week (although
The earliest ACGME requirements held that, minor exceptions for sound education purposes
“Resident physicians are expected to participate could be granted to individual programs) [9]. In
in safe, effective and compassionate patient care addition, the standards called for residents to be pro-
under supervision, commensurate with their level vided 1 day in seven free from all educational
of advancement and responsibility.” They also responsibilities, in-house call no more frequently
called for hospitals participating in resident edu- than every third night, continuous duty not to exceed
cation to be accredited by The Joint Commission 24 h, plus 6 additional h, “to participate in didactic
(or an equivalent external regulator) and that the activities, maintain continuity of medical and surgi-
program director and faculty members be appro- cal care, transfer care of patients, or conduct outpa-
priately certified and licensed. Initially there was tient continuity clinics.” Importantly, the 2003
a most rudimentary requirement regarding qual- standards also clearly stated that, “All patient care
ity improvement that all deaths be reviewed and must be supervised by qualified faculty. The pro-
that autopsies be performed in sufficient number
to enhance the quality of patient care [4].
Table 47.1 ACGME/ABMS general competencies for
Requirements regarding patient safety and specialty-based graduate medical education
quality assurance advanced only slowly over the
• Patient care that is compassionate, appropriate, and
next two decades. The 1992 Requirements stated effective
that, “Institutions … must conduct formal quality • Medical knowledge of biomedical, epidemiologic, and
assurance programs and review complications socio-behavioral sciences as applied to patient care
and deaths. Residents must be informed of the • Practice-based learning and improvement that
institution’s organization for, and methods of, involves investigation and evaluation of their own
patient care, appraisal and assimilation of scientific
providing quality assurance. They should partici-
evidence, and improvements in patient care
pate in the quality assurance activities of the clin- • Interpersonal and communications skills that result in
ical services to which they are assigned” [5]. effective information exchange and collaboration with
In 1995, the requirement was added that, patients, their families, and other health professionals
“Institutions must provide residents with an • Professionalism as manifested through a
opportunity to participate in institutional commit- commitment to carrying out professional
responsibilities, adherence to ethical principles, and
tees and councils, especially those that relate to sensitivity to a diverse population
patient care review activities and to develop an • Systems-based practice as manifested by actions that
understanding [of] how to apply cost containment demonstrate an awareness of and response to the larger
measures in the provision of care” [6]. The last context and system of health care and effectively call
requirements of the ACGME as a council of the on system resources to provide optimal care
47 Surgical Graduate Medical Education Program Accreditation and the Clinical… 801
gram director must ensure, direct, and document for physicians to appear for duty appropriately
adequate supervision of residents at all times” [10]. rested, the need of the [residency] program to be
The next major revision of the ACGME both committed to and responsible for promoting
Requirements occurred in 2007 [11]. That change patient safety and the active participation of resi-
further refined some of the requirements regard- dents in interdisciplinary clinical quality improve-
ing patient safety and introduced the term “qual- ment and patient safety programs. The program
ity improvement” into ACGME requirements. director and the institution were charged with
They stated that residents are expected to, “sys- ensuring a culture of professionalism that supports
tematically analyze practice using quality patient safety and personal responsibility. This
improvement methods, and introduce changes requires the residents and the faculty members to
with the goal of practice improvement,” “work demonstrate an understanding and acceptance of
effectively as a member or leader of a health care their roles in assuring patient safety, provision of
team or other professional group,” be accountable patient-centered care, and their fitness for duty. It
“to patients, society and the profession,” “coordi- requires their management of their time during,
nate patient care within the health care system but equally importantly, before and after clinical
relevant to their clinical specialty, advocate for assignments, recognition of impairment from any
quality patient care and optimal patient care sys- cause in themselves and their colleagues and mon-
tems, work in interprofessional teams to enhance itoring of their patient care performance improve-
patient safety and improve patient care quality ment indicators. It also emphasizes the need for
and participate in identifying system errors and residents and faculty members to demonstrate
implementing potential systems solutions.” responsiveness to patient needs that supersedes
In 2009, the ACGME convened a “Duty Hours self-interest.
Task Force” to reexamine ACGME resident duty A new section on “Transitions of Care” was
hour requirements [12], partly in response to the also added. It emphasized the need to minimize
2009 Institute of Medicine report on resident duty the number of transitions, resident competency in
hours [13]. Based on Task Force recommenda- the handover process and the need for programs
tions, the ACGME added several requirements and institutions to ensure and monitor hand-over
regarding resident duty hours to those in place process that facilitate both continuity of care and
since 2003. Notably, PGY-1 residents were limited patient safety [15]. A third section was added titled,
to 16 h of continuous duty and a minimum of 8 h “Alertness Management/Fatigue Mitigation.” It
between scheduled on-duty periods. Other resi- underscored the importance of educating faculty
dents were limited to 24 continuous h plus 4 h for members and residents regarding signs of fatigue
transitions in care. Intermediate-level residents and sleep deprivation, alertness management and
were given a minimum of 8 h between scheduled fatigue mitigation strategies. It also required pro-
duty periods and at least 14 h free of duty after grams to have processes to ensure continuity of
24 h of in-house duty. Residents in the final years patient care in the event that a resident was unable
of education were allowed somewhat more flexi- to perform his/her duties. Prior to 2011, the
bility within the context of the 80-h per week limit. ACGME Requirements said only that the [train-
Strategic napping was encouraged. Finally, the ing] program must ensure that qualified faculty
2011 requirements mandated that all moonlighting provide appropriate supervision of residents in
be counted toward the maximum weekly hour patient care activities [11]. The 2011
limit of 80 [14]. Requirements “Supervision of Residents” con-
What began as a Duty Hours Task Force tains nearly two pages of specific requirements.
expanded its mission to encompass quality care Among other things, these requirements address
and professionalism. Their recommendations in the need for the patient to be informed of the role
these areas are also reflected in the 2011 of the resident, codify the levels of supervision
Requirements [14]. An entire section was added that residents should have based on their abilities,
titled, “Professionalism, Personal Responsibility, and call for programs to set guidelines regarding
and Patient Safety,” which emphasized the need circumstances under which the attending

p hysician must be informed of a patient’s condi- he Clinical Learning Environment

T
tion [16]. They also set specific limits on the (CLE)
degree of autonomy granted to PGY-1 residents.
The previous section highlighted the evolution
that ACGME has taken to increasingly address
atient Safety and Quality
P the issues of patient safety and quality improve-
for Institutions Seeking to Sponsor ment through its regulatory function, specifically
ACGME-Accredited GME (Institutional its accreditation process for sponsoring institu-
Requirements) tions and residency and fellowship programs. As
noted at the beginning of this chapter, the
Beyond the Common Program Requirements, ACMGE has recently added a new program,
the recommendations of the 2009 ACGME Duty CLER, to further address the issues of patient
Hours Task Force were also manifested in the safety and health care quality in the graduate
ACGME Institutional Requirements and in the medical education community.
ACGME Policies and Procedures. Notable addi- The program was an additional outcome of
tions to the Institutional Requirements included the 2009 ACGME-convened “Duty Hours Task
requirements that the Sponsoring Institution and Force” to reexamine ACGME resident duty hour
its ACGME-accredited programs to assign resi- requirements [10]. This new program has a direct
dents only to sites that facilitate patient safety link to the accreditation process; specifically that
and health care quality; that residents have each ACGME-accredited sponsoring institution
access to systems for reporting errors, adverse must complete a CLER site visit every
events, unsafe conditions and near misses in a 18–24 months. Failure to meet that single require-
protected manner; and that residents have oppor- ment places the sponsoring institution and all of
tunities to contribute to root cause analysis or its residency and fellowship programs at risk for
other risk- reduction processes [17]. Quality an adverse accreditation decision, including
improvement was also emphasized by requiring withdrawal of ACGME accreditation. It is impor-
that residents have access to data to improve sys- tant to note that as a formative learning activity
tems of care, reduce health care disparities and each CLER visit concludes with a summary
improve patient outcomes and opportunities to report of findings specific to that CLE and not a
participate in quality improvement initiatives summative judgment that influences accredita-
[18]. Also added were requirements that tion decisions. The findings are confidential,
Sponsoring Institutions must facilitate profes- shared only with the leadership of the sponsoring
sional development for faculty members and resi- institution and the CLE that was visited. In
dents regarding effective transitions of care and designing the CLER program, the assessment
ensure that residents utilize standardized transi- assumes that the basic issues at that sponsoring
tions of care consistent with the setting and type institution and its training programs are compli-
of care. The revised Institutional Requirements ant with ACGME standards. ACGME standards
also required the addition of a quality improve- set the basis for patient safety and quality
ment/safety officer to the Graduate Medical improvement, whereas the CLER program seeks
Education Committee which oversees the quality to drive continual learning and systems
of the GME learning and working environment improvement.
[14]. Like the ACGME Institutional Requirements, A full description of the CLER program is
the first major revision to the ACGME Policies beyond the scope of this chapter and can be found
and Procedures following the report of the Task elsewhere [20]. In short, each CLER visit con-
Force became effective 1 July 2013. That docu- sists of 2–3 days that include structured group
ment provided the policy structure for the Clinical interviews with CLE and GME leadership, qual-
Learning Environment Review (CLER) [19] ity and patient safety leadership, residents and
(Fig. 47.1). fellows, faculty members, and program directors.
Fig. 47.1 Quality improvement

CLER findings
Also a series of walking rounds through the clini- experience and life-long patterns of care. A study
cal areas that are managed by the site visitors in by Asch and colleagues assessing obstetrics resi-
an effort to have a series of interviews with other, dency programs and their graduates demonstrated
non-physician, members of the clinical teams. that women treated by obstetricians trained in
Each visit ends with an exit interview where a residency programs in the bottom quintile for
summary of the findings is presented and that is risk-standardized major maternal complication
followed up in approximately 8 weeks with a rates had an adjusted complication rate approxi-
written summary of the visit. mately one-third higher than that for women
Currently the CLER program does not have a set treated by obstetricians from programs in the top
of published guidance or recommendations on the quintile [22]. Similarly a study by Chen, et al,
clinical learning environment specifically designed compared the regions of residency training and
for the surgical community. It is first worth consid- found that the way trainees were trained corre-
ering why ACGME establishes a program that lated with subsequent expenditures for care pro-
examines the clinical learning environment. vided by practicing physician spending patterns
associated with Medicare expenditures [23].
hy Is the CLE Important
W
in the Training of Residents hy the Current Need for Attention
W
and Fellows? to the Clinical Learning Environment
for Surgeons in Training?
The clinical learning environment (CLE) repre-
sents the structural space in which knowledge he Surgical Health Care Environment
T
and skills are transferred by experiential learning The rapidly evolving needs of the US health care
in the course of patient care. The CLE also repre- system, the current skills of surgical faculty, and
sents the community of colleagues in which expectations of surgical residents all are important
learners are exposed to attitudes and behaviors reasons to examine the clinical learning environ-
related to teamwork [21], communication, and ment. The health care environment is undergoing
professional interactions. Two recent studies significant evolution, and factors outside of the
underscore the importance of the clinical learn- surgical CLE are presenting surgeons and surgical
ing environments and their impact on the resident training with new challenges. Clinicians face the
need to manage a rapidly changing body of [30], with deference to expertise and an environ-
knowledge and dramatically changing technolo- ment that encourages all on the team to speak up
gies as well as integration of the electronic health and contribute fully to the team’s approach to
record in daily practice. There are also changing patient safety and quality [31].
technologies for learning, such as increased use
of simulation for training and assessment and Surgical Learners
just-in-time audiovisual learning (e.g., watching The young surgeon learners are also different—
a video on a new or unfamiliar procedure is inquisitive, yet very oriented toward instant com-
replacing the former practice of reading about the munication, and with greater expectations for
procedure in a textbook). attention to their learning, as well as to work–life
The health care environment calls for clini- balance and wellness [32, 33]. Young surgical
cians to have leadership skills that include team learners are also coming into surgical training as
dynamics management to a greater extent than natives to computers and gaming skills. In the
ever before [24]. Clinicians are also increasingly advancing implementation of the electronic
expected to focus on clinical efficiency and Lean health record, it is frequently seen that the stu-
[25] production methods, which at times may dents and trainees are quick to identify the issues
seem to physicians to be in conflict with time for with functionality and connectivity across health
patients and for teaching. There is a heightened care settings, and they are also quick to contrib-
emphasis on clinical accountability and transpar- ute to problem-solving and improving design
ency. Expectations for public reporting of patient [34]. Their comfort with gaming skills puts them
care quality and outcomes continues to grow and at a significant advantage for rapid adaptability to
is increasingly accompanied by changes in the new technologies in health care—such as mini-
reimbursement model to one based on value— mally invasive, robotic, and catheter-based pro-
i.e., quality and safety metrics—that are attrib- cedures—and often with faster and more adept
uted to the surgeon of record and the health care acquisition of skills than those who are responsi-
system in which surgical care was delivered [26]. ble for training them.
urgical Faculty: Teaching Clinicians,

S
Clinical Educators Challenges and Barriers for Surgeons
Historically, surgical training has focused on the
quality of care of individual patients; and very It is relatively easy and straightforward for clini-
few faculty were formally trained in population- cians to be strongly in favor of patient safety, high
based care management and health systems quality health care, and professionalism. However
design and performance [27]. While working simply identifying these and other focus areas in the
hard to maintain proficiency or expertise in the clinical environment, then implementing policies,
knowledge and skills of their own surgical spe- staff roles, and didactic curriculum does not guaran-
cialty, surgeon educators are also challenged to tee a quality CLE [35]. There are numerous chal-
have or gain mastery in systems thinking and lenges and barriers to improving the clinical
design, by which to improve patient flow, infor- learning environment [36], a few of which are noted
mation flow, and surgical team productivity [28]. here.
Additionally, there is a need to manage team One challenge for surgeon faculty in their
dynamics effectively. For example, new team assessment of the CLE is to separate themselves
management techniques, such as crew resource and their reputation from the way surgeons have
management [29], were not likely part of the traditionally viewed their own educational pro-
training of most of the surgical faculty. High cesses. Surgical faculty may consider that their
functioning teams require a change from the tra- many years of hard work and lost sleep invested in
ditional hierarchical model of surgeon as leader education and training is the principal link to the
to a flatter, more horizontal culture of teamwork quality of work that each delivers on behalf of his
or her patients. Thus, any critique of this model for team are working hard, but not learning how to
training surgeons cannot help but be taken person- make a meaningful impact on the health of the
ally and interpreted as an attack on the individuals population served [42–44].
themselves. Rites of passage and longstanding tra-
ditions that view the ability to power irrespective
of patient complexities, competing obligations, Focus Areas and Key Questions
and extreme exhaustion are deserving of reexami-
nation in light of increasing literature in the fields The ACGME Board of Directors recognized in
of quality improvement and patient safety. developing the CLER program, the necessity of
Another challenge or barrier to improved surgi- signaling the need for improvement that would
cal training has been the often times absent or lead to higher quality and reliability of care. For
inconsistent availability of relevant measures with this new effort they chose to employ a formative
meaningful definitions of quality of surgical care learning effort rather than a summative, regulatory
for both processes and outcomes. If surgeons do assessment built on requirements. In establishing
not find the measures relevant to delivery of qual- what would become the CLER program, the Board
ity care or the definitions reflecting meaningful identified six areas within the CLE that at the time
activity of the surgical team, then it is difficult to they thought were of highest priority to assess.
engage surgeons in contributing to improving the These focus areas included: patient safety, health
metrics [37]. If the data sources are not perceived care quality and quality improvement, transitions
by the practicing surgeon as valid and reliable, of care, supervision, fatigue management and mit-
then the data that are provided will not be trusted, igation, and professionalism. Within health care
much less acted upon, except under mandate or quality and quality improvement, there is an
duress. opportunity to consider vulnerable populations
The use of data for improvement has and the risk for and improvement of health care
advanced with use of data registries such as the disparities [45]. These focus areas are not unique
National Surgical Quality Improvement Project to surgical specialties, but within the surgical
(NSQIP) [38], or data shared among members learning environment, there are specific and/or
of the University Health System Consortium special characteristics and functions to be called
[39]. Trauma registries and tumor registries out for practical application. Also, these six areas
have added data and information for improving may evolve overtime as the ACGME Board of
practice. There are some surgical specialty Directors identifies new priorities within CLEs to
societies (such as the Society of Thoracic target for improvement.
Surgeons) that have demonstrated the value in The CLER program has been built on a frame-
use of such national databases to improve work of both the six focus areas as well as five
patient care outcomes at the local, regional and key questions related to each clinical learning
national levels [40, 41]. environment for GME, as shown in Fig. 47.2.
Surgeons who regularly review data on their These focus areas and questions help assess
patient care processes and their patients’ clinical the CLE to provide formative feedback to
outcomes and demonstrate use of data to better teaching medical centers and hospitals across
understand the patient population served and to the USA, as they consider how their strategies
improve their processes of care, model important and priorities translate to patient care at the
attitudes and behaviors that residents and fellows bedside. This approach may help the GME
will begin to incorporate into their practice. This community begin to learn and apply what inno-
is particularly true of efforts to reduce health care vative surgeon educators and health care orga-
disparities—i.e., if the efforts to provide access to nizations are doing to integrate the surgical
care regardless of ability to pay or other popula- learners and faculty into the system approach to
tion characteristics are not analyzed for the patient safety and health care quality and qual-
impact on outcomes, then the surgeon and his/her ity improvement. As patterns and practices are
Fig. 47.2 Central questions for the CLER evaluation. Modified from the AGME CLER executive summary, 6/10/2012
identified to improve both patient care out- elsewhere [46]. The next section explores some of
comes and GME outcomes, such assessments the findings in light of how surgical residents and
will begin to influence and inform the accredi- fellows experience their CLE as compared with
tation standards for GME institutions and their those residents and fellows in medical specialties
clinical sites. or other hospital-based specialties.
When asked if they, as residents or fellows,
experienced a patient safety event in the past year
Early CLER Findings while training at the hospital or medical center;
71 % of surgical learners reported such an experi-
The first cycle of ACGME clinical learning envi- ence, compared to 68 % of medical learners and
ronment review (CLER) site visits in 2012–2015 64 % of hospital-based learners (p < 0.0001). Forty-
visited the primary clinical participating site for six percent of the surgical residents and fellows
each of 297 sponsoring institutions that sponsored reported that they reported an adverse event through
three or more core programs. These CLER visits their hospital or medical centers patient safety sys-
included group interviews with 111,482 resident tem. This was less frequent than medical specialty
and fellow physician representatives, of which learners with 51 % (p < 0.0001).
21.8 % were in surgical specialty programs, Patient safety is enhanced when providers and
57.4 % in medical specialty programs, and 20.8 % systems learn from near misses, rather than focus-
in hospital-based specialty programs. These visits ing only on the post hoc learning when the patient
also included interviews with hundreds of CEOs, has already suffered harmed and in morbidity and
executive leadership teams from the hospitals and mortality conferences [47]. Of the physician
medical centers, as well as hundreds of other clin- learners interviewed, surgical residents and fel-
ical staff, primarily nursing. A full report of the lows who had reported a near miss event was
findings from this first cycle of visits can be found 19 %, compared to 22 % for medical specialty
learners and 17 % for hospital-based specialties dent and fellow physicians reported that they
(p < 0.0001). would power through to handoff, rather than
Beyond the reporting of patient safety events notify someone and be taken off duty, if placed in
to help the system learn and improve, the per- a situation in which they are maximally fatigued
centage of PGY3 and above resident and fellow and impaired in spite of caffeine and a nap.
physicians who reported participating in a hospi- Forty-two percent of the surgical specialty
tal- or medical center-led patient safety investiga- learners reported having documented a history or
tion, such as a formal root cause analysis, varies physical finding in a patient chart that they did
by specialty group, with surgical learners reporting not personally elicit—e.g., copying and pasting
greater participation—45, 40, and 37 % for surgi- from another note without attribution—com-
cal, medical, and hospital-based specialty learn- pared to 40 % of medical learners and 39 % of
ers, respectively (p < 0.0001). In discussions, hospital-based learners (p = NS). Though not
these activities were primarily through depart- found to show a statistically significant differ-
mental morbidity and mortality conferences with ence between surgical specialty learners and the
infrequent interprofessional participation and other specialty groups, 16 % of the surgical resi-
variable system-based problem solving [18]. dent and fellow physicians reported to have been
Surgical learners report lower participation in a pressured to compromise their honesty or integ-
quality improvement (QI) project, either of their rity to satisfy an authority figure during training
own design or one designed by their program or at the clinical site.
department—66 % as compared with 81 % and
73 %, for surgical, medical, and hospital-based
specialty learners, respectively (p < 0.0001). A ractical Approach to the Surgical
P
higher percentage (59 %) of surgical learners, ver- CLE Focus Areas
sus 52 % of medical learners and 45 % of hospital-
based learners, believed their project linked to one In 2014, the CLER evaluation committee, which
or more of the clinical site’s QI goals (p < 0.0001). provides oversight for the CLER program devel-
Ninety percent of medical and surgical specialty opment and then published the CLER Pathways
group learners reported following a standardized to Excellence: a set of expectations for an optimal
process for handling transitions of care during clinical learning environment [48]. The docu-
handoffs between shifts, compared with 80 % of ment was based primarily on the observations
hospital-based specialty learners (p < 0.0001). Of from the approximately first hundred CLER site
those who reported following a standardized pro- visits, along with the clinical experts on the eval-
cess, 84 % of medical learners, 76 % of surgical uation committee and what little published infor-
learners, and 63 % of hospital- based learners mation existed on CLEs in the literature. That
reported using a standardized written template for document describes in each of the six focus areas
communication during change-of-shift handoffs a series of paths by which a clinical learning
(p < 0.0001). Of note, the use of a standardized environment might seek self-improvement based
handoff process at change-of-shift was not cur- on the findings from the CLER visit.
rently maintained by surgical residents as they pro- This next section of the chapter provides some
gressed through training: 92.7 % for PGY2s, informal, select thoughts of the authors on where
91.7 % of PGY3s, and 87.5 % for those PGY4 and improvement strategies might be gain perched in
above (p < 0.01). clinical learning environments for the surgical
Twenty percent of surgical learners reported community.
that they had been placed in a situation or wit-
nessed one of their peers placed in situations Patient Safety
where they believed there was inadequate super- Physician leaders, along with practice and orga-
vision (e.g., the attending physician was not nization leaders, serve as role models by the way
available). Thirty-four percent of surgical resi- in which they recognize patient safety events
(adverse events, near misses, unsafe conditions), ment or skill and system errors and processes in
and use the reporting systems of the hospitals and need of improvement [51–53].
medical centers that serve as a their CLE. The structure and process for conduct of
The full range of reportable events includes patient safety investigations generally has five
near misses, events without harm, unsafe condi- components: review by an interprofessional team
tions, unexpected deteriorations, delays in diag- (physicians, nurses, pharmacists, administrators,
nosis and care, and procedural complications, as etc.), detailed analysis of systems and processes,
well as events with harm [49, 50]. Common identification of potential systems changes,
understanding among all members of the team implementation of an action plan, and follow-up
and organization about what constitutes a report- evaluation of the actions [54]. There are several
able event provides an important context for situ- methodologies that may be used for systematic
ational awareness while delivering patient care analysis of patient safety events—the five whys
and for system improvements. Patient event method, Ishikawa or fishbone diagramming, flow
reporting should drive the follow-up system for mapping, and cause-and-effect diagramming, to
event investigation and identification of cause, name a few [55]. There are numerous resources
with focus on reporting events and processes, for assisting physicians as they conduct and lead
rather than reporting as a means of retaliation or a patient safety event investigation, but it is just as
assigning blame to people. The patient safety important to include and involve the interprofes-
reporting system will be most likely used if it is sional team and to be sure that action plans and
perceived as adding value to patient care. If a follow-up are outcomes of the investigation [50].
hospital or medical center’s leadership is not It is imperative to disseminate the lessons
aware if its physicians are reporting patient safety learned in order to maximize the shared learning
events, there is the risk of having a significant across the organization or practice for transpar-
component of the health care workforce not see- ency and shared learning. This must, and can, be
ing the reporting of patient safety concerns as a done without HIPAA-violating patient details—
valuable contribution to system improvement. the focus is on the lessons learned and actions
Surgeons have long been mindful of the applied.
importance of tracking and trending patient out- Another aspect of transparency that is vital to
comes. To create a culture of safety means that a patient safety is disclosure of patient safety
CLE exists where all members of the clinical events to patients and families. As Dr. Donald
team are equally willing to speak up and report Berwick, former Administrator of the Centers for
patient safety concerns without fear of retalia- Medicare and Medicaid Services, and former
tion. Meaningful discussion and analysis of CEO of the Institute for Healthcare Improvement,
patient deaths and complications is essential to has put forward the useful guiding phrase to help
learning and improvement. Such discussions usu- clinicians remember the patient’s perspective,
ally take place in a venue known as a morbidity “Nothing about me, without me” [56].
and mortality (M&M) conference. There are dif- While the specific process for disclosure in a
fering views across US teaching medical centers practice or organization is in large part dictated
as to whether morbidities and mortalities as pre- by the pertinent state laws, the team is well served
sented in M&M conferences should be reported to understand the process that applies locally, and
and analyzed as patient safety events. From the to support one another in consistent application
patient’s perspective, a morbidity or mortality of that process. Preparing surgeon learners to
would very likely be considered a patient safety apply these tools and methodologies in their daily
concern, with great desire that the clinicians also practice as part of their professional commitment
do their due diligence in assessing for both indi- to their patients will benefit their patients
vidual error due to inadequate knowledge, judg- throughout their career [57] (Fig. 47.3).
Fig. 47.3 Patient safety CLER findings
ealth Care Quality and Quality

H that immediately apparent. Microsystems of sur-
Improvement gical care involve interprofessional teams work-
Patient safety and quality improvement are part ing together in a coordinated way to deliver and
of a continuous spectrum of interrelated clinical improve care. That means that quality improve-
activities. Efforts to improve patient safety ment initiatives involve multiple interprofes-
require knowledge and skills in quality improve- sional stakeholders [27].
ment tools and methodologies. Essential to learn- Clinicians who are immersed in a quality
ing quality improvement is to encounter it as improvement culture are supported by ready
experiential learning through practice and appli- access to data for regular review as well as for ad
cation. Just as physicians learning surgical skills hoc queries in order to better understand their
in the operating room need practice with the clinical effectiveness. Hospital and practice qual-
instruments and technical skills of the specialty, ity improvement leaders are generally immersed
they need practice in applying the tools and skills in data and performance measures, particularly as
of designing, leading and facilitating quality required for externally required reporting.
improvement [58]. These include the ability to However, it is important for surgical faculty and
construct a well-defined, measurable aim, iden- their clinical teams to have regular access to valid
tify a balanced set of measures by which to iden- and reliable data, presented in a manner that pro-
tify that patient care is actually improved (clinical vides relevant information in order to measure,
and functional outcomes, costs, and satisfaction), monitor and improve processes and outcomes.
and apply a systematic approach to serial cycles Significant surgical faculty development may be
of change that include evaluation of follow-up required to know how to make good use of the
action for progressive or continuous quality data provided to identify information for
improvement [59, 60]. improvement and to lead by example.
Clinical teams and their leaders are well Quality improvement is often applied to under-
served to be familiar with and practiced in sys- use of evidence-based care, such as efforts to
tems thinking, particularly about their surgical increase hand hygiene, cancer screening, and med-
microsystem(s) of care [61], to consider the ication adherence [62]. Opportunity also lies in
impact of a change in the system and its pro- addressing overuse and misuse of evidence-based
cesses that may have a ripple effect far beyond care that includes excess or unnecessary use, such
as decreasing excess imaging, unnecessary sur- with the surgical team, including in and out of the
gery, and inappropriate antibiotic usage. Many operating room, change of duty, team to team,
surgeons and clinical sites are familiar with service to service (including consultations), unit
addressing underuse through efforts such as to unit, admissions (outpatient to inpatient), and
increasing preoperative use of beta blockade for discharges (inpatient to outpatient or transfer to
cardiac patients and improving intraoperative glu- another facility or level of care). It is helpful to
cose control and normothermia [63, 64]. Surgeons identify which transitions pose the greatest risk
and clinical sites are also likely to be familiar with or vulnerability for patient safety issues, and par-
efforts to address overuse and misuse, such as cur- ticularly those that present the greatest risk of
rent examples of limiting the course of prophylac- patient transition with incomplete or inaccurate
tic antibiotics [63] and the overuse of urinary information, to identify key opportunities for
catheters. This area of improving evidence-based quality improvement in care transitions [68].
care continues to be an important foundation for A common language and systematic approach
other endeavors using surgical databases and within the handoff process that is most helpful to
improvement practices. the team members—with inclusion of key infor-
Another important use of quality improve- mation, if/then plans, opportunity for clarifying
ment tools and skills is through a systematic questions, and read-back to check for under-
approach to identifying variability in the care standing. Verbal communication can be enhanced
provided or the clinical outcomes of the patients and facilitated by use of a written tool, printed or
cared for in the surgeon’s department or practice, electronic, and access to a single electronic health
particularly for patients known to be vulnerable record (EHR) across the outpatient and inpatient
to having poorer clinical outcomes due to their continuum is ideal.
social or economic background. But by review of In that care transitions are team efforts, it is
aggregate data, especially outcomes data, with a also worthwhile to consider how to make hand-
breakdown by population characteristics (such as offs as interprofessional as possible. This helps
age, gender, race, ethnicity, socioeconomic sta- assure inclusion of the information handoff from
tus, etc.) for physicians and their clinical teams, other key members of the team, as available, such
there is an opportunity to better understand the as nursing, anesthesiology, critical care, and phar-
health and needs of the community served and macy. It also helps to make sure that team mem-
the impact of efforts to provide equitable access bers have a consistently understood plan of care.
and care. It is also important to consider inclusion of the
patient and/or family in key transition points [69].
ransitions of Care
T
Communication breakdowns have long been rec- Supervision
ognized as a root cause in approximately two- As educators, surgeons must extend their skills
thirds of sentinel events and are critical to the beyond the competency to perform the proce-
patient’s experience with transitions (handoffs or dures of their surgical specialty. In the task of
handovers) across the continuum of care [65, 66]. supervising they must exercise the very different
While handoffs of patients and their information skill set of teaching competency and assessing
has often been viewed by physicians as an oppor- competency while staying at an appropriate dis-
tunity for information to be lost, inaccurate, or tance to allow learners to process patient infor-
incomplete. However, a handoff can also be an mation and develop a treatment plan. But in the
opportunity for fresh eyes and ears to catch some- tactile world of surgery, supervision in surgical
thing that may have been overlooked or under- training also means assuring that the patient is
appreciated prior to the handoff [67]. safe and appropriate decisions are made while
There are numerous types of transitions of the supervisor’s hands are not holding the instru-
care for a patient in the course of the experience ments—i.e., from the other side of the table. That
fine art of providing guidance to someone else’s their patients. Yet there has been an ongoing
eyes and hands requires trust in one’s own abili- debate that patients are no safer and surgical train-
ties and judgment as well as progressive trust in ing has been compromised because of duty hours
the skills and judgment of the surgical learner. limitations [72–74]. Studies continue to evolve in
Such guidance comes in the form of a systematic this area, including a recent non-blinded cluster-
approach to the diagnostics, the procedure itself, randomized trial to better study this important
and to the treatment plan for recovery following a issue [75].
procedure. Increasingly, simulation education It therefore it is important faculty, residents,
offers a valuable resource for conveying a struc- and fellows, and other members of the health care
tured approach to teaching and learning skills, team, become familiar with the signs of fatigue,
judgment, and interprofessional teamwork for and then to have sensible mechanisms to assist
the learner, while ensuring patient safety [70]. the fatigued individual to protect them and their
The next aspect beyond the teaching of skills patients. For surgical faculty it would benefit the
and judgment is the assessment of learning and program to continually scan the environment for
competency. This can be very difficult for sur- situations in the clinical setting that pose greatest
geons at times, in that while appreciating the risk for fatigue and impairment, especially related
preference for objective assessment tools and to patient safety vulnerabilities. Beyond fatigue
methods, surgical skills assessment often is recognition training, it is beneficial for surgeons
described as subjective judgment or “I know it within a practice group or clinical site to be
when I see it.” familiar with the available resources and strate-
Meaningful assessment of competency there- gies at that site for fatigue management and miti-
fore requires that surgeon educators be willing and gation. This is particularly helpful, as it is worth
able to deconstruct their good judgment into com- noting that there are additional reasons to be
ponent parts, identifying what he/she is looking fatigued beyond the number of hours on duty as a
and listening for, and in what sequence and to what clinician. For example, personal or family illness
degree the process is complete. The Entrustable or financial stressors, and other obligations can
Professional Competencies (EPA) approach offers drive acute and chronic fatigue, as well as burn-
one approach for establishing objective, observable out, in both learners and faculty [76–79].
performance criteria. This approach to supervision Another aspect of physician wellness worthy
can then be turned into an objective assessment of attention is physician burnout, which has been
tool and applied in serial fashion to progressive noted to affect learners and physicians of all lev-
responsibility with feedback, as well as used to test els and specialties [80–82]. Distinct from fatigue,
for proficiency and provide documentation of com- burnout may be characterized as emotional
petency [71]. In addition, a systematic methodol- exhaustion—losing enthusiasm for work, deper-
ogy for assessment of competency can be useful sonalization—treating people as if they were
for evaluating maintenance of skills after achieving objects, and/or a sense of low personal accom-
proficiency, as well as providing utility in the cre- plishment—having a sense that work is no lon-
dentialing and privileging process [16]. It should be ger meaningful [83]. Rather than waiting until
noted that simulation is an effective tool for con- the painful signs of burnout in hindsight after a
ducting assessment and providing feedback. crisis—or worse, following physician death by
suicide—surgeons have an important opportu-
atigue Management and Mitigation,
F nity to identify situations of greater risk for burn-
and Fitness for Duty out, be more attentive to and less willing to
The duty hours in residency and fellowship were explain away signs of burnout in self and others,
introduced to begin to address the impact of and to think proactively about and model well-
fatigue on physician learners and the safety of ness behaviors.
Professionalism or have a concern or question about the patient’s

When considering what it means to be a profes- care plan [84].
sional, the descriptors and definitions center on One practical way to improve teamwork,
values, attitudes, and behaviors. As the ACGME especially under stress, is to consider the impor-
considers professionalism in the CLE, it is diffi- tance of interprofessional team training. If we
cult to be comprehensive, so special attention is work as we drill, then appropriate training in
placed on honesty, integrity (including scientific and reinforcement of communication skills for
integrity), and professional interactions—how all in the organization (leaders, staff, physicians,
professionals treat each other and their patients learners) is worthy of drills that reinforce cohe-
and families. sive team functioning with respect and a shared
Significant professionalism issues arise that mental model, which enhances patient safety
require training and/or remediation during the [34]. This is particularly important for the often
course of residency and/or fellowship, and in ad hoc teams that are present in emergency
practice. One might like to assume that honesty, departments and operating suites [24]. It may
integrity and respectful treatment of others are also be beneficial to practice de-escalation and
present in all who would seek to apply to medical conflict management training to improve and
school. But if that is not a safe assumption, how promote respectful interpersonal interactions,
might a more appropriate filter and assessment be thus providing constructive means for managing
applied to those who seek to enter the profession, situational stresses and enhancing skills for
and how are high standards of professionalism working out differences of opinion without
kept as the norm among those who have attained compromising integrity [85].
positions of influence and accomplishment?
Practical consideration for what honesty
looks like in a surgical practice includes truthful ummary and Future
S
reporting of data and outcomes in surgical regis- Considerations
tries and databases, in accurate clinical docu-
mentation, and reporting on duty hours. So what does the surgical learning environment of
Scientific integrity may include whether an indi- the future look like? Practicing surgeons and sur-
vidual (regardless of level of training or rank) geon educators are urged to consider the assess-
has fulfilled a role sufficient and appropriate for ment suggested by Marshall Goldsmith’s book
inclusion in manuscript authorship, or whether title, “what got you here won’t get you there” [86].
the study materials utilized in preparation for Health care leaders for the future of health care are
in-training or board certification exams are of best served by understanding how to lead a learn-
legitimate sources. ing organization. Surgeon leadership involves car-
As to interpersonal interactions, there are ing about what matters to staff and to patients, and
those who have do not feel the need to manage being willing to work on system design for care
their emotions such that their temper flares that is both evidence-based and patient-centered.
when upset with a situation, and in the extreme, Moreover, surgeon educators have a special oppor-
individuals who gain a reputation for “tough- tunity to be leaders not only in the advancement of
ness.” Chronic or persistent disruptive behavior surgery, but also in the advancement of surgical
can likely influence the willingness and timeli- education, through data-driven, outcomes-focused
ness of physician learners and/or nursing staff care of individuals and of the various population
to contact the surgeon or call for assistance, groups within the community served.
which may result in a delay in care or otherwise The culture and motivations of a surgical team
impact patient safety. Dismissive or disrespect- or practice are critical to determining how the
ful behavior also likely has an impact on mem- team functions. Appreciating, studying, and apply-
bers of the care team, causing them to be less ing aspects of an effective organizational culture in
willing to speak up if they see something unsafe optimizing the health care delivery and learning
environment that include: a heightened situational 6. Essentials of accredited residencies in Graduate

Medical Education. In: Graduate Medical Education
awareness of the opportunity for error (rather than
Directory 1994–1995. Chicago, IL: American
assume that errors are rare and should be pun- Medical Association; 1994. P. 14.
ished); emphasis on interprofessional respect and 7. Essentials of accredited residencies in Graduate
value; interprofessional team communication and Medical Education: Institutional and Program
Requirements. In: Graduate Medical Education
improvement; openness and transparency for
Directory 1997–1998. Chicago, IL: American Medical
reporting errors, near misses, and unsafe condi- Association; 1997. P. 29.
tions, with emphasis on shared learning; motiva- 8. ACGME common program requirements effective. 1
tion from what matters to the patients and families; July 2002.
9. Philibert I, Barach P. Residents’ hours of work: we
and empowerment to make local improvements
need to assess the impact of the new US reforms.
that align with organizational goals. BMJ. 2002;325:1184–5.
Rethinking the learning environment compels 10. ACGME common program requirements effective. 1
surgeons to deconstruct and critically analyze July 2004.
11. ACGME common program requirements effective. 1
and enhance the good judgment that helps them
July 2007.
assess competency in a more objective manner. 12. Nasca TJ, Day SH, Amis ES. The new recommendations
Surgical system redesign can take greater advan- on duty hours from the ACGME Task Force. N Engl
tage of data and outcomes measurement to better J Med. 2010;363:e3.
13. Ulmer C, Wolman D, Johns M, editors. Resident
understand and optimize processes for improving
duty hours: enhancing sleep, supervision, and
patient flow and information flow, and assess for safety. Washington, DC: National Academies Press;
health care disparities. Finally, rethinking the sur- 2008.
geon stereotype involves critically considering 14. ACGME common program requirements effective.

1 July 2011.
the professional behavior and the how best to
15. Hesselink G, Schoonhoven L, Barach P, Spijker A,
socialize surgeons in training to model and build Gademan P, Kalkman C, Liefers J, Vernooij-Dassen
appropriate expectations from practicing sur- M, Wollersheim W. Improving patient handovers
geons and surgical learners alike. from hospital to primary care. A systematic review.
Ann Intern Med. 2012;157(6):417–28.
16. Sterkenburg A, Barach P, Kalkman C, Ten Cate O.
Disclaimer The views and opinions expressed in this Entrustable educational agents and patient safety.
chapter are those of the authors and do not necessarily Acad Med. 2010;85:1408–17.
reflect the official policy or position of the ACGME. 17. ACGME requirements for sponsoring institutions.

1 July 2013.
18. Vohra P, Daugherty C, Mohr J, Wen M, Barach P.
Housestaff and medical student attitudes towards
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Affordable Care Act, Public
Legislation, and Professional 48
Self-Regulation: Implications
for Public Policy
Stephen J. Lahey
“America’s health care system is neither healthy, caring, nor a system.”

—Walter Cronkite
Introduction companion agency: Medicaid for low income

individuals and the disabled) as a government-
A manufacturing expansion, unlike anything seen financed health care insurance plan to be overseen
before, was required to keep pace with demands by the Health Care Financing Administration
of the US war effort. Following the war, the sud- (HCFA) later to become the Centers for Medicare
den manufacturing boom would look to the thou- and Medicaid Services (CMS). The retired
sands of returning GIs to provide the workforce American would now have the means to maintain
necessary to fuel the largest industrial revolution access to health care for the remainder of his/her
in the history of the world. These emerging com- life. In this newly created health care system, phy-
panies saw health insurance as an enticement to sicians would be reimbursed by the federal gov-
attract and keep loyal employees. Literally over- ernment for every encounter with a patient, be it
night, the manufacturing industry entered and an interpretation of a laboratory value or perform-
became a dominant figure in US health care. ing major surgery. More importantly, there was no
Two decades later, a new question became evi- limit to the number of times that a physician could
dent: what was to become of the worker who left submit a claim for services provided, for which
the ranks of the employed and was entering the the federal government, through Medicare, duti-
ever-growing demographic niche of the retired fully reimbursed the clinician. The so-called “Fee
American? No longer would these citizens have for Service” reimbursement system took root.
health insurance. Responding to this looming Although not appreciated at that time, the seeds
health care crisis, President Lyndon Johnson were sewn for the current US health care crisis.
signed into law the Social Security Act of 1965. The World War II returning GIs not only pro-
As part of this remarkably progressive legislation, vided the manpower for this modern manufactur-
the US Government created Medicare (and its ing revolution, they also created a new societal
demographic: the “Baby Boomers.” Through the
late 1960s, 1970s, and 1980s, health care costs to
the federal government expanded at an alarming
rate (Fig. 48.1). The Medicare beneficiaries were
S.J. Lahey, MD (*) becoming older, sicker and their health care more
Division of Cardiothoracic Surgery, Department of costly. With no limits on the Fee for Service
Surgery, University of Connecticut School of system and with the specter of the largest demo-
Medicine, UCONN Health, 263 Farmington Avenue,
Farmington, CT 06030-3955, USA graphic population, i.e., Baby Boomers, looming
e-mail: [email protected] on the economic horizon, it became evident to

818 S.J. Lahey
Fig. 48.1 Per Capital Health Care Spending since 1980 by country [1]
health planners and strategists, that the current publication of the Medicare Fee Schedule (MFS)
reimbursement methodology was not sustainable in the early 1990s.
by the US economy. The staggering economic bur- As the harsh realities of financial catastrophe
den of an 11.4 % annual increase in Medicare associated with out-of-control health care costs/
spending from $36.4 billion in 1980 to $120.2 bil- spending became accepted as inevitable by
lion in 1991 [2], pushed HCFA, Congress and the forward- thinking health care strategists in the
entire federal government to appreciate the critical late 1980s, several isolated “demonstration proj-
need for health care cost containment. Legislation ects” appeared on the health care landscape. The
soon followed that attempted to cap hospital reim- rationale behind the development of these proj-
bursements and codify all short-term, acute care ects was that hospital and physician reimburse-
hospital Medicare reimbursements under an ment could be effectively contained by a system
In-patient Prospective Payment System (IPPS), of “bundled” payments. These projects tended to
which fundamentally changed the method by be focused on surgical procedures with one of the
which hospitals were reimbursed. Previously, hos- most notable early projects started by Dr. Denton
pital reimbursement was retrospective, based on Cooley at the Texas Heart Institute in 1984. At
hospital costs in a fee-for- service manner. The the core of their claim of success was that they
IPPS ushered in a reimbursement methodology were able to reduce costs without compromising
that was prospective and based on known costs their traditional high quality [3].
associated with a series of Diagnostic Related Perhaps the most ambitious, early project was
Group (DRG) classifications. These DRG pay- conducted by HCFA in 1991. Out of a possible
ments allowed Medicare to reimburse hospitals 209 pre-applications for participation in this
not according to costs incurred but rather based on study, four US hospitals were chosen to take part
patient diagnosis and comorbidities. Not surpris- in a demonstration of the feasibility of bundled
ingly, an attempt to contain the enormous increase Medicare payments for both the hospital (Part A)
in physician reimbursement was initiated with the and the physicians (Part B) at a predetermined,
48 Affordable Care Act, Public Legislation, and Professional Self-Regulation: Implications for Public Policy 819
negotiated rate. The demonstration project was began with the Social Security Act of 1965. What
later extended to three additional hospitals in started as a reasonable method of assuring appro-
1993. A final report of the project findings were priate physician and hospital reimbursement while
published in 1998 [4] in which HCFA realized a guaranteeing full access to medical care for
savings of $42.3 million on coronary artery Medicare beneficiaries had, now, become the very
bypass surgeries, which was approximately 10 % mechanism responsible for out-of-control health
of the $438 million that had been expected as care spending and a serious drag on the entire US
Medicare payouts. Several other interesting find- economy. In addition, the Fee-For-Service method
ings were gleaned from this study: of reimbursement fostered fragmentation of care,
poor coordination amongst caregivers, and no
• The seven demonstration hospitals were found incentive to limit resource utilization. The impend-
to have significantly lower in-patient mortality ing US health care crisis was becoming likely and
rates than what was seen in risk factor con- the financial ramifications of rising health care
trolled rates in Medicare participating but costs were starting to be appreciated as threat to the
non-demonstration hospitals. entire national economy. For the first time, the mat-
• Multivariate analysis also demonstrated a sig- ter of financial solvency of the entire Medicare pro-
nificant reduction in complication (e.g., post gram began to enter the national health care
operative renal failure) rates and lengths of stay. dialogue. The current trend in health care spending
by the federal government would not be sustainable
It should be noted that Medicare, as a federal and the USA began to look for ways stop, or at
agency, whose original charge was to devise a least, abate this serious downward economic spiral.
method of health care cost containment, was now A new direction in governmental health care policy
very much interested in quality outcomes and pro- began to emerge as the realization that costs and
cess of care. It was apparent that control of health quality were irrevocably linked. Policy makers
care costs would not only require some form of understood that the pillars needed to strategically
bundled payment arrangement with hospitals and support this effort would be based on (see Fig. 48.2)
physicians but, also, would be permanently linked
to clinical outcomes. 1. Clinical data and subsequent reliance on

One other important notion becomes apparent evidence-based decision making
when reviewing the findings of this early demon- 2. Improvement in patient safety and quality

stration project: HCFA was keenly aware of the outcomes
“asymmetry of financial incentives faced by hos- 3. Congressional legislation that would ensure
pital managers versus physicians.” The physician the viability of the Medicare program
bears absolutely no financial down-side risk. The
fact that a patient requires an intensive care unit
for 2 days or 20, is irrelevant to the physician. In Evidence-Based Decision Making
addition, the pre-procedure negotiated payment
to surgeons increases with the complexity of the Accurate, reliable clinical data must be the bedrock
operation. These more complex surgeries may be of any legitimate effort to contain costs through
associated with a higher cost of care, which is better clinical outcomes. Substandard care is
essentially borne by the hospital. This has proven extraordinarily expensive. Early efforts in the
to be a rather vexing problem to this day. 1990s to introduce “Fast Track” cardiac surgery
As US health care, in particular, and the US brought to light an interesting revelation: the ability
economy, in general, limped into the twenty first to reduce hospital lengths of stay in a “Fast Track”
century, a consistent theme began to emerge: The program was predicated on improved processes of
enemy of cost containment efforts and simultane- care [5]. For example, limiting amounts of intraop-
ous maintenance of high quality of care was the erative intravenous fluid in the operating room
Fee-For-Service model of reimbursement that translated into shorter times to extubation, shorter
820 S.J. Lahey
Fig. 48.2 Factors impacting quality and costs
ICU lengths of stay and shorter overall hospital ical results. It is a remarkable example of
lengths of stay. Better care meant reduced costs. institutional transparency and cooperation and,
Efforts to boldly change the processes of care as such, has had an enormous effect on health
in cardiac surgery require: (a) the total commit- policy for many years.
ment of organizations to submit and share their The link between health care costs and quality
own clinical data with that of other institutions, of care was coming into sharp focus as a matter
(b) the organizational structure to provide robust of government public policy. Academic research
statistical analysis, and (c) a method of consistent in health policy, numerous private health care
feedback to the participation institutions so as to consulting firms, and government-sponsored
encourage data-driven changes in the care deliv- demonstration projects began to become com-
ered. The effectiveness of this exercise is directly monplace in the American health care environ-
related to the accuracy, completeness and trans- ment. One of the most interesting and
parency of data submitted. This truly innovative revolutionary projects, The Virginia Cardiac
approach to cardiac surgery (and medicine, in Surgery Quality Initiative (VCSQI) introduced
general) began with the pioneering efforts of many cardiac surgeons to the phrase “Pay-For-
organizations such as the Northern New England Performance” which started in 1994. These true
Cardiovascular Disease Study Group (the health care innovators, led by Dr. Jeffrey Rich,
“NNE”), the New York State Cardiac Surgery dedicated themselves to the notion that improved
Reporting System, and the Society of Thoracic outcomes and quality of care would necessarily
Surgeons National Database. All three organiza- evolve from a state-wide system of clinical out-
tions have provided valuable insights into con- come analysis, data sharing amongst its members
cepts such as the existence of significant and subsequent process of care change and
variability in clinical outcomes, procedural vol- improvement. The VCSQI, in effect, created a
ume statistics as a surrogate for quality in highly global pricing model based on rewards for
complex surgeries, and the linkage between pro- superior performance and, more importantly,

cess and outcome. The “NNE” represents the physician and hospital incentives were aligned by
voluntary cooperation of several institutions in a series of common objectives. Much later
the northern New England region, which rou- (2013), in his testimony to The House Committee
tinely collect, analyze and collectively share clin- on Energy and Commerce, Subcommittee on
Health, Dr. Rich stated that VCSQI collaborators In 1989, the STS National Database was created to
“point out that a road map of short-term next collect clinical data on every cardiac case per-
steps is needed to create an adaptive payment formed at participating institutions (currently in
system tied to the national agenda for reforming excess of 90 % of US cardiac surgery hospitals),
the delivery system. VCSQI has demonstrated provide robust risk-adjustment based on pooled
that improving quality reduces cost. For example, national data, and to provide critical data analysis
using evidence- based guidelines, VCSQI has feedback to participating hospitals (see Chap. 44).
generated more than $43 million in savings This remarkably powerful data registry has
through blood product conservation efforts and allowed for the creation of accurate risk predicting
more than $20 million by providing the best models that are used throughout the world [8]. The
treatment to patients with atrial fibrillation at the obvious importance of these risk models to shape
right time” [6]. public health care policy by agencies such as
In the state of New York, the Cardiac Surgery Medicare cannot be overstated.
Reporting System was created in 1989 and to this Numerous other clinical data registries have
day is an extremely active arm of the New York emerged across the country. Data analysis from
Department of Health. Unlike many other clinical all of these databases has become increasingly
databases, the NY CSRS is a statewide data regis- more sophisticated and has allowed for more
try for cardiac surgery and percutaneous coronary accuracy in risk modeling. The importance of
interventions. Participation by all New York insti- data registries is evident when considering the
tutions performing cardiac surgery is mandatory. critical utility of the STS database in activities
Risk adjusted mortality data, at the institutional such as setting reimbursement rates within the
and surgeon-specific levels, is publically reported. Resource Based Relative Value Scale (RBRVS)
These data are reviewed quarterly and alert letters for cardiothoracic surgical procedures (as defined
are routinely sent out to institutions should they by Current Procedural Terminology codes) at the
be found trending towards statistically significant American Medical Association/Specialty Society
increases in mortality rates. Those institutions Relative Value Scale Update Committee meeting
that are demonstrating significantly worse out- (RUC). Data from the STS database has allowed
comes have in-depth review of individual mor- the STS to offer an accurate assessment of physi-
talities by CSRS staff. The institutions are cian work based on time and intensity of each
required to provide clinical summaries of cases procedure as part of the relative value unit (RVU)
under review and action plans for process valuation by the RUC. These values are then for-
improvement. Occasionally site visits by CSRS warded to CMS for consideration, as mandated
staff and consultants are required. These efforts by Congress.
have resulted in dramatic improvements in risk Congressional agencies have noted the
adjusted mortality rates in the hospitals of power of the STS data registry and CMS has
New York State. Through robust efforts at aca- designated it as a Quality Clinical Data
demic literature production, the New York State Registry (QCDR). Clinical data submission to
CSRS has contributed significantly to both the the STS National Database satisfies the require-
fund of knowledge in outcomes research, but has, ment of CMS that eligible professionals must
also, demonstrated the power of public policy as participate in a Physician Quality Reporting
an effective agent of improving clinical outcomes System to avoid negative payment adjustments
and patient safety. Currently, approximately one- in the future. There is also general acceptance
third of state governments in the USA require that the STS Database is, perhaps, one of the
mandatory reporting of clinical data [7]. oldest, most mature and accurate of extant
The Society of Thoracic Surgeons was estab- databases. The future of cost containment mea-
lished in 1964 and currently is an international, sures and alternative payment methods may
nonprofit organization representing over 6600 sur- rely heavily on similarly constructed specialty
geons, researchers and allied health professionals. society databases.
822 S.J. Lahey
I mproved Patient Safety One of the most effective methods employed

and Quality Outcomes by process improvement experts in any field is the
development of performance protocols. In medi-
As efforts to create powerful clinical databases cine, clinical protocols aim specifically at reducing
to guide process improvement projects and more variability of care delivered. Variability has long
favorable clinical outcomes intensified, CMS been known to negatively impact clinical out-
and other government agencies began to focus comes and make systems of care more prone to
on initiatives that addressed growing concerns medical errors. Government sponsored clinical
over patient safety. In 1999, the United States protocols and practice guidelines became a major
Institute of Medicine (IOM) issued a report enti- focus of US health policy in the 1990s. Between
tled “To Err is Human. Building a Safer Health 1992 and 1996, the Agency for Health Care Policy
System.” This landmark publication estimated and Research (now known as AHRQ) developed
that as many as 98,000 patients suffer entirely multiple clinical practice guidelines ranging from
preventable deaths in American hospitals each topics such as “urinary incontinence in adults” to
year as a result of medical errors. As shocking as “management of heart failure.” Because of the dis-
this sobering statistic was, it was not lost on turbing results of the “To Err is Human” report,
health policy experts that the additional costs health care policy makers understood that evi-
associated with these errors reached the stagger- dence-based decision making and protocol driven
ing amount of $17 to $29 billion dollars per year care would be major factors in reducing the dan-
in hospitals nationwide. One of the reasons pos- gerous variability thought to be a primary contrib-
ited by the report to account for this epidemic of utor to unnecessary deaths and complications.
devastating medical errors was a health care Today, these protocols and many more have been
delivery system (such as it is) that was hope- updated and expanded and are available for down-
lessly fragmented with no coordination of care load through the Department of Health and Human
by the multiple caregivers for any given patient Services website: www.ahrq.gov.
[9]. To make matters worse, a health care system
based on a Fee-for-Service method of reim-
bursement provides no incentive for caregivers Congressional Legislation
to centralize and coordinate care—in essence,
clinicians are perversely rewarded for their mis- The single-most important health care-related leg-
takes because every patient encounter is islation passed in the twenty first century was the
billable. Patient Protection and Affordable Care Act
With the gauntlet (the IOM Report) thrown (ACA). This sweeping health care reform bill has
down, the government’s response by both the dominated public policy discussion since its stun-
Clinton Administration and Congressional com- ning passage by Congress in 2010. At its core, the
mittees with medical jurisdiction, began to hold ACA, together with Health Care and Education
hearings on this patient safety crisis. The govern- Reconciliation Act amendment, attempt to drasti-
ment and CMS clearly understood the critical cally reduce the ranks of the under- and uninsured
implications of this game-changing report and in the USA and to dramatically expand access to
needed to address the issue definitively and health care to as many Americans as possible.
quickly. One year later, in 2000, $50 million dol- However, if full implementation of ACA is ever to
lars was appropriated for the Agency for Healthcare be realized, policy makers cannot disregard the
Research and Quality (AHRQ) to investigate new fact that health care, as we know it, must undergo
technologies to reduce medical errors, conduct radical change to derail the “freight train” that is
large scale demonstration projects to address error out-of-control health care costs. In its current
reduction and patient safety, and fund research to form, US health care is not financially sustainable
develop provider education tools to help mitigate and threatens the solvency of critical entitlement
medical error rates [10]. programs such as Medicare and Social Security.
With this sobering fact as a backdrop, health care would provide the Medicare Payment Advisory
policy in this country has attempted to focus Commission (MedPAC) a budget report consist-
efforts to promote care coordination, decrease ing of total physician reimbursement expenditure
resource overutilization, and encourage evidence- versus the previous year’s target expenditure
based medical decision-making through data reg- estimation. A conversion factor was used to
istries and clinical protocols. This is being adjust the proposed expenditure budget for the
accomplished through a series of CMS mandates following year up or down based on the previous
and health care legislation to gradually shift health year’s performance. If expenditures exceeded
care away from traditional Fee-for-Service meth- estimates, reimbursement for the next year would
ods to alternative models of reimbursement in be scaled down to account for the loss. However,
which incentives of the many clinicians and hos- with no significant reduction in physician reim-
pitals, participating in a particular episode of bursement and Medicare spending, it very
patient care, are all aligned. It would follow, then, quickly became evident that Medicare would be
that this can only happen if (1) all stakeholders operating at a significant deficit each year and,
have the ability to share in financial gains achieved more importantly, that this deficit was, by for-
by cost efficient care and (2) all stakeholders share mula, cumulative and had to be reconciled. The
in the down-side financial risk if the cost of care total dollar amount, incurred by physician reim-
exceeds the predetermined and pre-negotiated, bursement overages each year was projected to
“lump sum” reimbursement rate for the given epi- reach staggering proportions. What ensued was
sode of care. Through public policy and national several pieces of Congressional legislation (the
dialogue, Medicare and governmental health so-called “Doc Fix”) aimed at delaying imple-
strategists have attempted to force a shift away mentation of these mandated cuts. In Washington,
from Fee-for-Service which encourages more and D.C. parlance, this amounted to “kicking the can
more volume with little incentive to reduce unnec- down the road” since it allowed Congress to
essary clinical testing, complications, or readmis- avoid a very unpopular mandate (for yet another
sions, to one of bundled costs with bundled year) and, in so doing, failed to address the fun-
payments. To understand the rationale and logis- damental issue that the accumulating SGR debt
tics of such an enormous shift in health care pol- was something that would eventually have to be
icy, one must understand five key concepts: paid but who was going to pay it and where was
the money going to come from. The price tag
1 . Sustainable Growth Rate (SGR) was in the hundreds of billions of dollars at a
2. Merit-Based Incentive Payment System (MIPS) time when other important financial burdens
3. Medicare Access and CHIP Reauthorization such as the US Department of Defense budget
Act (MACRA) was also growing at an alarming rate with active
4. Alternative Payment Models conflicts in Iraq and Afghanistan. Relief from the
5. Hospital Value-Based Purchasing steadily increasing SGR debt finally came in the
form of the Medicare Access and CHIP
Reauthorization Act (MACRA) of 2015, which,
Sustainable Growth Rate among other things, summarily repealed the
SGR formula.
In 1997, the US Congress passed the Balanced
Budget Act within which was an amendment
known as the Medicare Sustainable Growth Rate. edicare Access and CHIP
M
This was a method used by Medicare to contain Reauthorization Act (MACRA)
yearly health care costs by mandating that
Medicare costs per beneficiary were tied to, and Signed into law by President Barack Obama in
could not exceed, growth of the national Gross 2015, MACRA was created to repeal the physi-
Domestic Product (GDP). Each year, CMS cian reimbursement methodology of SGR and
824 S.J. Lahey
allow physicians to choose one of two distinct • Quality = 50 %

pathways to future reimbursement: • Advanced Care Information = 25 %
• Clinical Practice Improvement Activities = 15 %
1. Merit-Based Incentive Payment System (MIPS) • Cost = 10 %
2. Alternative Payment Models (APM)
Beginning in 2019, physicians failing to meet
predetermined performance thresholds estab-
Merit-Based Incentive Payment lished by CMS, will be subject to a negative 4 %
System (MIPS) Medicare reimbursement penalty. In the 3 suc-
ceeding years, this penalty for performance fail-
The MIPS program offers clinicians a schedule ure increases to negative 5, 7, and 9 %. Success in
of reimbursement that is a less radical change to meeting the performance thresholds will be asso-
what they have traditionally been accustomed ciated with a 4 % bonus in 2019, and 5, 7, and 9 %
since it represents a modification of the Fee-for- positive bonus in the subsequent 3 years.
Service model. The program allows for bonus
payments to eligible physicians who can be mea-
sured on certain domains of performance: Alternative Payment Models (APM)
• Quality—similar to the Physician Quality A second pathway to physician reimbursement is

Reporting System (PQRS) previously in use. the voluntary participation of clinicians or groups
Eligible physicians can choose six quality mea- of clinicians in APMs. At present, an APM can
sures to report to CMS (one of which must be accommodate a fee-for-service construct with par-
an outcome measure or a high value measure). ticipants willingly accepting “down side” finan-
• Advanced Care Information—eligible physi- cial risk with the hopes of realizing significant
cians will document use of key measures of positive revenue through gain sharing if care is
information technology interoperability and efficient, coordinated, patient-centered, and linked
information exchange. to quality. However, in the future in its simplest
• Demonstration of Clinical Practice form, CMS would agree to pay out one “lump
Improvement Activities, e.g., population man- sum” payment to a group of participating caregiv-
agement, care coordination, care plans/shared ers for a given episode of care. It would be the
patient decision making, and patient safety participants themselves who would determine dis-
checklists. Clinicians can choose from a list of tribution of reimbursed revenue and, in so doing,
90 proposed activities. enhance transparency of care delivered. It is
• Cost—This will be a measure efficiency of believed that this method of reimbursement would
resource utilization and will replace the Value- strongly encourage coordination of care and curtail
based Modifier program. This will be calcu- resource over utilization. Some notable examples
lated by CMS and will be based on claims data. of APMs are Accountable Care Organizations
Unlike the previous three domains that require (ACOs) and Patient-Centered Medical Homes. A
physician data input, the Cost domain will be separate category of APM, the “Advanced
provided to the physician entirely by CMS. Alternative Payment Model” also exists. This
expanded form of APM is intended to be more rig-
Based on the performance score achieved in each orous in its requirements for eligibility. In addition
of these four performance categories, a MIPS to the MIPS-type performance measures that are
Composite Performance Score (CPS) will be required, the Advanced APM requires that partici-
calculated. pants utilize Certified Electronic Health Record
Each of the performance categories are not technology, receive payments based on the MIPS
equally weighted in calculating the overall MIPS quality measures and, finally, that participants
Composite Performance Score (CPS): either construct their APM in the form of a
Medical Home or agree to accept “more than a completely borne by CMS and the federal
nominal amount of financial risk.” As can be government?
expected, the financial bonuses awarded to suc- • Alternative Payment Models, as envisioned by
cessful Advanced APMs will be greater than that the federal government, appear to be ideally
which will be paid out to the conventional suited for population health and primary care
APM. As yet, it has not been determined what services. How can subspecialty practitioners
constitutes “nominal” risk. effectively participate in APMs of the future?
Physician and hospital organization across the
country are actively attempting to create efficient Intense efforts are currently underway between
and high quality APMs that can manage the chal- CMS contracted consulting firms, medical spe-
lenge of providing the highest quality care possi- cialty societies, and numerous health care organi-
ble while assuming both the up-side financial zations to assess feasibility, practicality and
risks (i.e., bonuses) and the down-side financial organizational structure of the “ideal” Alternative
risks (i.e., penalties). This is proving to be a sur- Payment Model. Clearly, the challenges facing a
prisingly difficult task [11]. Several specific, medical home proposed APM, which has, as its
important impediments to creation of these APMs major focus, primary care and preventative medi-
are emerging: cine, are quite different for APMs, which would
include subspecialty surgical practices.
• How do APM participants deal with issues
affecting outcome that are beyond their con-
trol and are not specific to the episode of care Hospital Value-Based Purchasing
for which the patient is being treated? For
example, dialysis dependent renal failure in a While much of the focus has been on methods of
patient admitted for coronary artery bypass physician reimbursement, CMS has also insti-
surgery. tuted the Hospital Value-Based Purchasing
• Who determines what constitutes an episode (HVBP) program, which attempts to link reim-
of care? For example, a patient admitted to the bursements to the hospitals for in-patient services
hospital for the DRG: Mitral Insufficiency. to the overall quality of care delivered rather than
The treatment, resource use, and overall work volume of care delivered. In this methodology, a
of treating a patient with mitral insufficiency certain percentage of Medicare reimbursement to
are completely different depending on the eti- the hospital is withheld and used as incentive to
ology. A patient with “floppy mitral valve syn- provide the highest quality care possible. The
drome” causing insufficiency is usually healthy HVBP program has established 20 quality mea-
and the surgery is relatively uncomplicated. sures whose performance enables CMS to esti-
On the other hand, a patient with mitral insuf- mate quality of care. The hospital is scored on
ficiency from a massively dilated, low ejection either achievement of the quality measures or
fraction left ventricle is extraordinarily diffi- demonstration of improvement from the previous
cult to treat with very different resource use year. Adjustments in Medicare reimbursement to
and quality outcome expectations. hospitals, relative to historical payouts for indi-
• How are issues of medical malpractice liabil- vidual Diagnosis-Related Group codes, can be
ity to be adjudicated? Will all members of the made and are based on score achieved.
APM be liable for the failure of one participat-
ing consultant who fails to recognize a critical
laboratory test value? Conclusion
• How will newly formed APMs pay for conver-
sion to an acceptable electronic health infor- The history of US government public policy as it
mation technology that will be extraordinarily relates to health care in America is one of
expensive? Should this cost be partially or remarkable evolution from the simple concept of
826 S.J. Lahey
governmental agencies created to assure all citi- 3. Liu CF, Subramanian S, Cromwell J. Impact of global
bundled payments on hospital costs of coronary artery
zens access to consistent health care for life to
bypass grafting. J Health Care Finance.
complex strategies to contain out-of-control 2001;27(4):39–54.
health care costs while maintaining the highest 4. Cromwell J, Dayhoff DA, McCall NT, Subramanian
quality care delivered. The sheer enormity of S, Freitas RC, Hart RJ, Caswell C, Statson W.
Medicare participating heart bypass demonstration.
medical spending in the twenty first century has
Executive summary. Final report. Waltham, MA:
made health care a major political factor as it Health Economics Research, Inc.; 1998.
began to assume larger and larger percentages of 5. Lahey SJ, Borlase BC, Lavin PT, Levitsky S.
the national Gross Domestic Product. This fact Preoperative risk factors that predict hospital length
of stay in coronary artery bypass patients over 60
can no longer be ignored by any of the stake-
years of age. Circulation. 1992;86(5 Suppl
holders: physicians, hospitals, patients, medical II):181–5.
industry (including device and pharmaceutical 6. House Committee on Energy and Commerce,
industries), politicians, and the US Government Subcommittee on Health. Hearing: reforming SGR:
prioritizing quality in a modern physician payment
through its many medical agencies and legisla-
system. 5 June 2013.
tive bodies. We are in the midst of a seismic shift 7. Barach P, Lipshultz S. The benefits and hazards of
in US health care—how it is delivered and how it publicly reported quality outcomes. Prog Pediat
is paid for. Health care in this country is extraor- Cardiol. 2016;42:45–9. doi:10.1016/j.ppedcard.2016.
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dinarily complex and so are the many strategies
8. Jacobs JP, Edwards FH, Shahian DM, Haan CK,
proposed to make it better, more cost effective Puskas JD, Morales DL, Gammie JS, Sanchez JA,
and safer. Going from where health care was 50 Brennan JM, O’Brien SM, Dokholyan RS, Hammill
years ago to where it will ultimately end up, will BG, Curtis LH, Peterson ED, Badhwar V, George
KM, Mayer Jr JE, Chitwood WR, Murray GF, Grover
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Surgical Quality and Patient Safety
in Rural Settings 49
Amy L. Halverson and Julie K. Johnson
“A physician is obligated to consider more than a diseased organ, more even than the
whole man – he must view the man in his world.”
—Harvey Cushing, MD
Access to surgical services is an essential com- acute lower respiratory tract infection and measles
ponent of medical care and is indispensable as immunization. The authors also emphasized the
part of a functioning health care system [1]. In a importance of developing sustainable infrastruc-
2011 article in the World Health Organization tures for surgical care rather than focusing
Bulletin, Bae and coauthors discussed the failure efforts on short-term medical missions [2].
of international organizations to recognize sur- The report from an international symposium
gery as a fundamental component of global held in November 2014, the “Amsterdam
health [2]. The authors explained that failure to Declaration on Essential Surgical Care,” states that
embrace surgery, a public health intervention, is surgical diseases kill more individuals worldwide
due in part to the misconception that surgery than HIV, tuberculosis, and malaria combined [3].
treats only a small portion of the burden of dis- Essential surgical care is defined as “Basic surgi-
ease. The shift of the burden of disease is from cal procedures that save lives and prevent perma-
communicable diseases to noncommunicable nent disability or life-threatening complications.
conditions and injuries, with injuries accounting Such surgery should be of appropriate quality and
for approximately 10 % of deaths globally. safety, accessible at all times and affordable to the
Noncommunicable diseases and injuries require community.” At the 2015 World Health Assembly,
more surgical interventions. A second miscon- the World Health Organization (WHO) detailed
ception is that surgical care is disproportionately the need for surgical and anesthetic services in
expensive, yet surgical and obstetric care are low-resource areas of the world, and passed a res-
comparable to the cost effectiveness of other olution to strengthen emergency and essential sur-
public health interventions, such as vitamin A gical care and anesthesia as a component of
distribution, detection and home treatment of universal health coverage.
There has been much needed attention regard-
ing access to surgical care in resource-poor coun-
A.L. Halverson, MD, FACS, FASCRS (*)
Section of Colon and Rectal Surgery, Northwestern tries; however, there are also millions of individuals
Medicine, Northwestern University, in the USA who lack access to surgical services.
Chicago, IL, USA Twenty to 25 % of US citizens reside in rural areas
but only 10–15 % of physicians practice in these
J.K. Johnson, MSPH, PhD areas [4]. Thompson and coauthors calculated the
Department of Surgery, Center for Healthcare Studies,
ratio of surgeons in rural areas to be 4.67 general
Institute for Public Health and Medicine, Feinberg
School of Medicine, Northwestern University, surgeons per population of 100,000 compared to
633 North St Clair, Chicago, IL 60611, USA 6.53 per population of 100,000 in urban areas [5].

828 A.L. Halverson and J.K. Johnson
Nakayama and Hughes cite data that 18 % of Rural Urban Commuting Areas codes (RUCAs) to
federally designated hospital service areas have no classify the rural nature of a community. The clas-
surgeon of any specialty and 30 % of the service sification system was initially developed in 1999
areas have fewer than three general surgeons per and subsequently revised to include data on travel
100,000 [6]. The relative lack of surgeons in rural time and distance to more urban areas in addition to
areas is expected to worsen over the next decade. the population of a community [7]. Critical access
Many surgeons currently practicing in rural areas hospitals (CAH) are a subset of rural hospitals that
are older and there is concern that as they retire, it meet specific criteria. In 1997, the US Congress
will be difficult to recruit younger surgeons to take established the Medicare Rural Hospital Flexibility
their place. Furthermore, rural surgeons, compared Program. The goals of this program were to support
to their urban colleagues, face unique challenges states in establishing rural health care networks.
including professional isolation and lack of access This program designated certain hospitals as
to professional development activities. “Critical Access Hospitals.” Hospitals seeking des-
This chapter discusses the implications of sur- ignation of a CAH must meet several criteria: (1) be
gical programs in rural USA, how rural hospitals located in rural areas and be at least 35 miles from
and Critical Access Hospitals are defined, chal- any other hospital (exceptions may apply); (2) have
lenges facing rural surgeons, and how patients liv- no more than 25 acute care beds; (3) offer 24-h
ing in rural communities make decisions about emergency services, and (4) not exceed an average
seeking surgical care. We discuss rural hospitals annual length-of-stay of 96 h [8]. The size and
as a system, including issues facing rural hospitals length of stay limitations were established to
concerning regionalization of surgical programs encourage treatment of common conditions and
and measures of quality and value. We conclude outpatient care while referring patients with other,
with a series of potential research questions that more complex conditions to larger hospitals. As of
could help us better understand the role, vitality, March 2016, there were 1331 CAHs in 45 of the 50
and context of rural surgical health care. United States (see Fig. 49.1). CAH have limited
financial and human resources and are paid by the
Centers for Medicare and Medicaid (CMS) on a
Definition of a Rural Hospital hospital cost basis rather than the diagnostic related
group based payment that is used for inpatient care
Rurality may be defined by the population of a covered by CMS at other hospitals. This reimburse-
community and the distance of that community ment system was instituted to prevent the closure of
from a metropolitan area. In addition to geo- small hospitals that were losing money. Despite this
graphical distance, the remoteness of a commu- effort, many small rural hospitals, including CAH
nity is a function of the functional relationship of continue to close [10]. States that chose to not
a community, as measured by working commut- expand Medicaid as part of the Affordable Care Act
ing flows with larger cities and towns. For exam- feel the most financial pressure. Since 2010 more
ple, a small community that has limited economic than 70 rural hospitals have closed. (Source = http://
development and is 50 miles from an urban cen- www.ivantageindex.com/vulnerability-index/)
ter via a two-lane highway is much different from
a community of similar size that is connected to a
larger city via interstate highways with high he Rural Surgeon: Challenges
T
speed limits and a large number of citizens who and Solutions to Practicing
commute to the larger city on a daily basis. in a Rural Setting
In a collaborative effort, the Office of Rural
Health Policy, the United States Department of Rural surgeons often serve several clinical and
Agriculture Economic Research Service and the administrative roles within the hospital. Their
Washington, Wyoming, Alaska, Montana, and responsibilities may include medical director of
Idaho (WWAMI) Rural Health Research Center the operating room, managing trauma systems
and the University of Washington developed the and overseeing critical care. In the majority of
49 Surgical Quality and Patient Safety in Rural Settings 829
Fig. 49.1 Location of Critical Access Hospitals. flexmonitoring.org/wp-content/uploads/2013/06/CAH_

Permission to reprint confirmed from location of critical 031816.pdf. Updated 2016. Accessed 03/24, 2016 [9]
access hospitals. Flex Monitoring Team. http://www.
rural hospitals, anesthesia is provided by nurse upper and lower endoscopy, including both diag-
anesthetists and the surgeon is the supervising nostic and therapeutic procedures [12–15].
physician depending on individual state laws. Many rural surgeons are in solo practice.
Several studies have suggested this greatly Without partners, rural surgeons have frequent, if
increased the overall risk of anesthesia care. Silber not continuous, call responsibilities, lack of
et al., found 2.5 excess deaths within 30 days of highly skilled assistance for difficult cases, and
admission and 6.9 excess failures-to-rescue lack of coverage for time away. Professional iso-
(deaths) per thousand cases when an anesthesiol- lation has been singled out as the most important
ogist was not involved [11]. Clinically rural sur- challenge faced by surgeons in rural practice
geons have a broader scope of practice than their [16]. Often rural surgeons are in solo practice and
urban counterparts. In addition to cases com- therefore have limited opportunities to discuss
monly under the domain of general surgery, such surgical problems with colleagues. Another com-
as cholecystectomy, appendectomy, colectomy monly cited challenge is a relative lack of access
and hernia repair, rural surgeons may perform to continuing medical education that matches the
other oncologic, otolaryngology, vascular, uro- scope of practice of the rural surgeon and
logic and orthopedic procedures. In some com- specifically addresses problems in the context of
munities rural surgeons also perform gynecologic a rural practice [17]. These barriers exacerbate
procedures and cesarean sections. A significant the ability of rural hospitals to attract and retain
portion of the rural surgeon’s practice consists of surgeons.
Various solutions to address the problem of Table 49.1 Rural surgery learning modules
work burden and professional isolation have been Leadership and communication
described in recent literature, including forming Advanced endoscopy
group practices of two to three surgeons to pro- Emergency gynecology
vide dependable coverage [16]. The Gunderson Emergency urology
Lutheran system in LaCrosse, Wisconsin has Facial plastic surgery—lesion excision
created a model consisting of 25 regional sites Facial plastic surgery—laceration repair
that are supported by an academic, full-service Breast ultrasound
tertiary care center. All regional sites in the sys- Ultrasound for central line insertion
tem share a single integrated electronic medical Management of fingertip amputation
record. All surgeons in the system are members Laparoscopic common bile duct exploration
of a single Department of Surgery within the Anesthesia skills
Vascular surgery skills
Gunderson Health System and the surgeons at
regional centers participate in patient-focused
conferences and educational courses. The with rural surgeons, both one-on-one and in
regional surgeons have developed a coverage sys- groups, to brainstorm potential topics for course
tem based on geographical locations of the content. The initial discussions were followed by
regional practices. conducting a needs assessment of rural surgeons
Another unique approach is the University of as well as a literature review and review of rural
North Dakota’s rural surgery support program. A surgeons’ case logs [19]. In a flipped classroom
full-time faculty member of the medical school’s approach, course faculty provide participants with
Department of Surgery provides coverage to Web-based learning materials to review prior to
regional hospitals in 2-week increments. The billing attending the in-person session to maximize the
for all services provided by the covering surgeons is time spent in hands-on, mentored skills practice.
the responsibility of the regional health care facility. Each course module is developed with and taught
In addition to coverage, the University offers con- by content experts. The course is held annually.
tinuing education and consultation services. The curriculum consists of 12 modules that rotate
Recently the problem of professional isolation year-to-year [20] (Table 49.1).
has been addressed through creating an electronic
listserv, developed by Dr. Tyler Hughes, for rural
surgeons to communicate about various topics he Rural Hospital in the Context
T
related to rural life and surgical practice. Rural of a Care System
surgeons have an opportunity to present clinical
scenarios in order to obtain the advice, and some- A successful rural health care network relies on
times just empathy, of their surgeon colleagues. rural hospitals to provide readily accessible, high-
The overwhelming success of the listserv quality care. Additionally, there must be estab-
prompted the American College of Surgeons to lished, formal relationships between small rural
establish “Communities” for various interest hospitals and regional hospitals to facilitate the
groups among its members [18]. transfer of patients when they require a higher
To address the rural surgeons’ lack of access to level of care [21]. Considering the effectiveness of
continuing medical education that matches their a health network raises this issue of how to measure
learning needs, the American College of Surgeons quality, safety, and value of surgical care provided
established the course, “Advanced Skills Training at rural hospitals. A second consideration is deter-
for Rural Surgeons.” A team consisting of rural mining which clinical conditions warrant transfer
surgeons, academic surgeons, and individuals to a regional center based on the facilities and pro-
with expertise in adult education developed the fessional resources of the local hospital. A third,
course to be offered as part of the Nora Institute often neglected component to consider is the
for Surgical Patient Safety. The initial planning patient’s resources and preferences in obtaining
for the course involved numerous discussions care at a regional versus a local hospital.
Measuring Quality in Rural Hospitals difficult to interpret. The first is that CAHs were
not required to report the same quality measures
Casey and coauthors reported the efforts of an as other hospitals. Second, payment systems for
expert panel to identify quality measures relevant CAH may take away a financial incentive to
to critical access hospitals [22]. The panel evalu- improve quality and efficiency. Third, CAH have
ated CMS inpatient and outpatient quality report- not kept pace with improved technologies that
ing and electronic health record meaningful use improve patient outcome. Finally, patients at
measures as well as the Joint Commission and CAHs have higher comorbidities and a higher
other National Quality Foundation endorsed burden of social and financial problems.
measures. Surgical quality measures that were In contrast to a gap in outcomes for medical
identified as potentially useful and cost effective admissions, subsequent studies have found no
included perioperative antibiotic prophylaxis, such difference in outcomes for surgical admis-
venous thromboembolism, measures to reduce sions in CAH and non-CAHs. Gadzinski and
UTI and perioperative temperature control. coauthors utilized data from the American
Additionally, the panel supported the reporting of Hospital Administration and the National
Hospital Consumer Assessment of Healthcare Inpatient Sample (NIS) to compare CAH and
Providers and Systems (HCAHPS) data. The non-CAHs in terms of surgical outcomes [24].
expert opinion panel recommended that future Although CAHs comprised 26.2 % of patients
surgical quality measure developments include a included in the study, only 1.3 % of the opera-
surgical checklist measure and additional mea- tions were performed at CAHs. Patients admitted
sures focused on high-volume outpatient proce- for surgery at CAHs were generally younger and
dures such as gastrointestinal endoscopy [22]. had fewer measured comorbidities compared to
Prior studies have shown disparities in the patients at non-CAH facilities. The authors found
quality of medical care in rural vs. urban hospi- that operative caseload at CAHs consists of
tals. Joynt and coauthors evaluated quality pro- mostly general surgery, OB/GYN, and orthope-
cess measures for Medicare beneficiaries dic procedures. These classes of procedures com-
admitted between 2002 and 2010 with pneumo- prised nearly 96 % of procedures in CAHs,
nia, acute MI and congestive heart failure in 1268 compared with 77 % of non CAHs. The most
CAHs [23]. In 2002 the mortality rates for these common procedures performed included appen-
conditions at critical access hospitals were simi- dectomy cholecystectomy, colectomy, cesarean
lar to noncritical access hospitals. However, over section, hysterectomy, hip fracture repair, hip
the study interval, the mortality rates increased in replacement and knee replacement. Mortality
critical access hospitals resulting in a significant rates for these procedures were similar for CAHs
gap for all three conditions compared to noncriti- and non-CAHs. The exception was hip fracture
cal access hospitals. Even when compared to repair. The mortality risk for this procedure was
other rural noncritical access hospitals of similar higher compared with non CAHs in patients with
size, increased mortality rates were again Medicare as the primary payer (adjusted odds
observed at the critical access hospitals. The ratio [AOR] = 1.37; 95 % CI, 1.01–1.87) and for
authors compared critical access hospitals that patients with elective admissions (AOR = 2.65;
improved over the study interval (414/857 95 % CI, 1.20–5.82). The authors opine that
(48 %)) to critical access hospitals that did not increased mortality for hip fracture repair may
improve. The only observed difference was a reflect the urgent treatment of older patients with
slightly higher median resident income in the more comorbidities. An additional finding was
critical access hospitals that had a decreased that despite shorter lengths of stay, (p < .001 for
mortality rate. The authors proposed several pos- four procedures), costs at CAHs were 9.9–30.1 %
sible explanations for why mortality rates wors- higher (p < .001 for all eight procedures).
ened at the majority of critical access hospitals Natafgi and coauthors also found similar rates
aside from smaller sample sizes making results of complications in CAHs compared to other small
(fewer than 50 beds) hospitals without critical geon play several roles in the hospital, a hospital
access designation. The authors evaluated hospitals quality leader may also have several other clini-
on six patient safety indicators: death, postoperative cal and administrative responsibilities to compete
hemorrhage and hematoma, respiratory failure, for their time and attention. A third challenge is
deep venous thrombosis or pulmonary embolism, the low volume of surgical procedures performed
sepsis and postoperative wound dehiscence. After at rural hospitals which makes it difficult for a
adjusting for patient and hospital characteristics, single hospital to track meaningful outcome mea-
the authors found that critical access hospitals per- sures [26].
formed the same or better than the small community
hospitals in all indicators [25].
A recent study by Ibrahim and coauthors add Regionalization of Care
more evidence that critical access hospitals pro-
vide high quality and cost effective care. The A well-functioning rural health network depends
authors conducted a retrospective review of more upon a predictable and reliable interaction
than one million Medicare beneficiary admis- between rural hospitals and larger regional hospi-
sions for one of four common surgical proce- tals. The role of the rural hospital in a health net-
dures including appendectomy, cholecystectomy, work is to provide local care for basic procedures.
colectomy and hernia repair. The authors found Patients with conditions requiring more complex
that critical access hospitals had mortality and treatment will be transferred to regional centers.
morbidity rates that were comparable to noncriti- With this approach, it is important to determine
cal access hospitals. Critical access hospitals had what cases are appropriate for local care and
significantly lower rates of serious complications which patients should be transferred. Hospitals
(6.4 % vs. 13.9 %; OR, 0.35; 95 % CI, 0.32–0.39; may determine a priori that certain conditions
p < 0.001). Furthermore, Medicare expenditures necessitating complex surgery should be man-
adjusted for patient factors and procedure type aged at a larger hospital with appropriate
were lower at critical access hospitals than non- resources. Challenges to developing and main-
critical access hospitals. ($14,450 vs. 15.845, taining the smooth functioning of such a system
p < 0.001). for surgical patients include managing patients
In addition to outcome measures, the Hospital with acute conditions that warrant emergent
Consumer Assessment of Healthcare Providers intervention and managing patients with routine
and Systems (HCAHPS) scores provide another surgical problems who have significant medical
measure of quality of care. A 2011 report showed comorbidities. Rural residents have higher rates
that 41 % of CAHs reported HCAHPS scores. of diabetes, cardiac failure, mental health,
These results from these hospitals demonstrated tobacco use and obesity. Additionally, an increas-
significantly higher HCAHPS scores compared ing proportion of rural patients are elderly [27].
to all other hospitals [8, 22]. There is the argument that regionalization of
The majority of studies of quality in rural hos- care equals better care. However, regionalization
pitals are based on large administrative databases. may unduly restrict the surgeons providing care.
There is a paucity of studies utilizing risk- This is a complex issue that must take into
adjusted, abstracted data such as that used in pro- account many factors, including the complexity
fessional databases, e.g., the National Surgical of a procedure, the surgeon’s annual volume and
Quality Improvement Program (NSQIP). Many the surgeon’s cumulative experience. In a sys-
rural hospitals operate on a narrow financial mar- tematic review of the effect of volume and expe-
gin and do not have the financial resources to rience on outcome, Marruthappu and coauthors
cover the cost of participation in these programs. found that the relationship between volume and
Additionally, hospitals may lack personnel to outcome is not consistent. Also, determining ade-
abstract data and to develop and implement qual- quate volume to reach a level of mastery varies
ity improvement programs. Just as the rural sur- widely among surgeons and procedures studied.
The authors found that experience as measured areas (HR 1.038, 95 % CI, 1.007–1.071; p = 0.016)
by years in practice and annual case volume cor- even after adjustment for stage and other patient,
relate to health outcome and are not related to tumor, and treatment factors. Given the limita-
specific procedures [28]. tions of their database, the authors could not
Procedures most commonly performed in adjust for hospital factors or surgeon factors such
rural hospitals include endoscopic procedures, as hospital case volume, surgeon specialty, or
cholecystectomy, breast procedures, hernia repair surgeon case volume [30].
and colectomy. Complex operations such as pan- While regionalization may be important in
creaticoduodenectomy and esophagectomy are providing care in sicker patients and those
not being performed at small rural hospitals. patients needing complex procedures, regional-
Markin and colleagues studied 20 oncologic pro- ization has the potential to limit access to care
cedures performed in rural hospitals from 1998 for some patients. For example, Dr. Arnold Hill
to 2009 and showed that throughout the study commented on the efforts of the Republic of
period, the most common oncologic procedures Ireland to regionalize cancer treatment. In 2006
performed at rural hospitals were resections of Ireland introduced a program to consolidate can-
the colon, rectum, breast, or uterus. The propor- cer treatment from 32 hospitals throughout the
tion of oncologic procedures performed at rural country to eight designated cancer centers. This
hospitals decreased from 12 % in 1998 to 6 % in system left patients in some areas having to
2009. Multivariate analysis showed that, overall, travel increased distances for care. In response to
undergoing an oncologic procedure at a rural the new system, surgeons at non-cancer center
hospital did not confer an increased risk for post- hospitals either retired or transitioned a portion
operative mortality (OR of mortality, 0.93; of their practice to the cancer center hospitals or
p = 0.08). However, surgery at rural hospital moved their practice entirely. There did not seem
increased the risk of mortality following complex to be a reciprocity on the part of the cancer
operations including resection of lung, pancreas, center hospital surgeons to transfer out patients
esophagus or bladder compared to other gastroin- with uncomplicated, benign conditions requir-
testinal procedures, (mortality following coming surgery. There was a resulting disincentive
plex procedure compared to gastrointestinal for surgeons to practice outside of the eight des-
procedure in rural hospital OR 2.10 (1.67–2.64), ignated cancer centers.
in non rural hospital OR 1.49 (1.40–1.59)) [29]. In summary, a system of regionalization
More recently, Chow and colleagues com- should be built upon solid relationships between
pared colon cancer treatment in rural and urban rural hospitals and regional centers. The role of
hospitals using a California state-wide database. the regional center should be to provide support
The authors assessed four quality indicators: to the smaller outlying hospital and their sur-
stage at diagnosis, number of lymph nodes har- geons. This relationship may be facilitated by
vested, receipt of chemotherapy for stage III dis- surgeons at different hospitals agreeing on which
ease and mortality. Patients living in rural areas types of operative cases and patient conditions
were more likely to be diagnosed with stage III are appropriate for transfer to a higher level of
and IV disease (OR 1.037, 95 % CI 1.001–1.075, care. The agreed upon patterns of care should
p = 0.043). Rural patients with stage I to III dis- weigh the burden of travel for the patient with the
ease were less likely to have ≥12 lymph nodes clinical benefit of more specialized care. The sys-
evaluated compared with their urban counterparts tem should allow routine operative procedures to
(OR 0.808, 95 % CI 0.777–0.840, p < 0.001). remain at the outlying hospitals to maintain job
Rural patients were less likely to receive adjuvant satisfaction for the surgeons. Additional support
chemotherapy (OR 0.863, 95 % CI 0.799–0.932, for the outlying surgeons may be providing the
p < 0.001). Additionally patients living in rural opportunity for the outlying surgeons to partici-
areas had a 4 % higher risk of death from their pate in multidisciplinary conferences related to
cancer compared with patients living in urban cancer care.
Patient Preferences and Resources have surgery include a surgeon’s technical skills

and experience, professional reputation and inter-
Studies addressing the regionalization of care have personal skills. Participants often expressed estab-
primarily focused on process measures and clinical lishing a good rapport with their surgeons helped
outcomes. Relatively few studies have considered them feel more comfortable about the surgery and
the patient’s values when weighing the benefits of perioperative care plan. Hospital factors that
regionalization of care. Studies that evaluate influenced where participants chose to have sur-
patient preferences for care consistently demon- gery included the hospital’s reputation, the exper-
strate that patients prefer to seek care at a more tise of other specialist and hospital resources. A
local facility. In 1999 Finlayson and coauthors third theme affecting patient’s choice of treatment
conducted a study in which 100 patients were location was personal factors such as finances,
given a hypothetical scenario of undergoing a employment issues, and social support. While
Whipple procedure locally or at a hospital 4 h these were not the primary deciding factors, the
away by car. The patients were asked where they personal issues contributed to the burden that the
preferred receiving care if the operative mortality care entailed. Many patients travel several hours
risk was equivalent at both hospitals. Through an for treatment. They had to contend with the cost
iterative process, patients were then asked whether of transportation, the necessary time away from
their preference changed with increasing mortality work and the cost of accommodations to have sur-
risk at the local hospital. All patients indicated that gery in a location where they did not have existing
they would prefer to have surgery at the local insti- social support mechanisms [32].
tution if operative mortality risk were 3 % at both Tai and colleagues used administrative
the local and regional hospitals. If operative mor- Medicare data to show that among Medicare
tality risk at the local hospital was doubled, 45 of enrollees residing in rural areas, 56 % of hospital-
100 patients would still prefer to undergo surgery izations were at the patient’s closest rural hospi-
locally. If local risk were 9 percentage points tal. Patients with complex medical conditions,
higher (four times the regional risk), 23 of 100 surgical and psychiatric diagnoses were more
patients would prefer to undergo surgery locally. If likely to bypass the closest rural hospital to seek
local risk were 15 percentage points higher (6 treatment. Additionally those with greater eco-
times the regional risk), 18 of 100 patients would nomic resources were more likely to bypass
still prefer local surgery [31]. nearby hospitals. Patients with a local primary
In a qualitative study, Nostedt and colleagues care physician and those older than 85 years of
interviewed patients from rural areas undergoing age were less likely to bypass the closest hospital
surgical treatment at regional center in Winnipeg [33]. The findings of this study are consistent
[32]. Factors that affected patient’s decision to with prior studies that showed travelling long dis-
seek care at an urban center were categorized tances is a deterrent to hospital choice and indi-
according to three main themes. First, patients viduals with a greater complexity of illness
have varying levels of input regarding the deci- tended to choose larger rural and urban hospitals
sion of where to seek surgical care. Some patients over smaller rural hospitals [34].
do not perceive that they have a choice in deter- A more recent study done by BCBS of
mining treatment location and they follow recom- Tennessee found that 69.9 % of patient stays were
mendations by primary care doctors, not at the member’s closest geographic facility.
gastroenterologists, oncologists or other surgeons After eliminating procedures that were not
without discussion treatment options. Second, offered at a closer facility, still, 43.4 % of patient
patients consider treatment factors, including sur- visits were at a more distant facility. Patients trav-
geon factors and hospital factors when consider- eled on average 23 miles farther than the closest
ing treatment location. Surgeon factors that facility. The authors opine that patients are more
contribute to a patient’s decision about where to likely to travel for health care due to mobility
including helicopter transfer, technology— 1. What are the financial and social burdens to
regional centers have technology that the smaller patients when they are referred outside their
hospitals cannot afford, and capacity or regional community for surgical care and in what ways
hospitals to accept more patients Distance from a can portions of their care such as preoperative
facility did not affect adherence for mammo- optimization and postoperative follow-up care
grams or whether individuals with back pain had be kept within the local community?
surgery. This study does not apply to the unin- 2. How can rural and regional hospitals improve
sured or those with Medicaid or Medicare [35]. collaboration and how can communication
optimize the coordination of care for patients?
3. How do we best support rural hospitals in
Conclusion quality improvement efforts?
4. What strategies can be employed to support
This chapter addresses three essential compo- surgeons in rural practice and recruit new sur-
nents to providing quality surgical care in rural geons to impede the growing shortage of sur-
areas: the patient, the hospital in the context of a geons in rural areas?
health care system and the surgeon. Further
research on quality improvement in rural surgical
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Global Surgery: Progress
and Challenges in Surgical Quality 50
and Patient Safety
Christopher Pettengell, Stephen Williams,
and Ara Darzi
“Of all the forms of inequality, injustice in health care is the most shocking and inhumane.”
—Dr. Martin Luther King, Jr.
contexts. The World Health Organisation (WHO),

Introduction define patient safety as
… the absence of preventable harm to a patient
A provision of care for surgical disease should during the process of healthcare. The discipline of
be a prerequisite for all health systems in all patient safety is the coordinated effort to prevent
countries, worldwide. The delivery of this surgi- harm, caused by the process of healthcare itself,
from occurring to patients [3].
cal care should be high quality and safe. The
international recognition and propagation of We consider health care quality in terms of
landmark works, such as To Err is Human [1], three core areas: clinical effectiveness, patient
and involvement in quality reporting databases experience, and patient safety [4]. Hence, there
(e.g. the American College of Surgeons National are extensive links between a health system that
Surgical Quality Improvement Program, ACS is considered safe and one that is considered of
NSQIP) [2] has brought the topics of quality and high quality—as we discuss further below.
safety to the fore in the minds of health leaders In this chapter we discuss surgical care provi-
and policy makers. sion globally, making reference to the limited
While there is an ever growing body of peer- progress that has been made to date in the fields of
reviewed literature on both patient safety and sur- quality and safety, while isolating the ongoing
gical quality, neither holds a uniform definition, challenges we all must look to address in the
presenting something of a dichotomy, since we future.
must firmly establish what we mean by “quality”
and “safety” before if we are to consider these
attributes in a robust manner across diverse health The Donabedian Model
In 1988, Donabedian published a model that con-

ceptualizes quality in health care as three interre-
C. Pettengell, BMBCh, MA (oxon), MRCS
S. Williams, BMBCh, MA (oxon), MRCS lated components, namely “structure,” “process,”
A. Darzi, FRS, FMedSci, HonFREng (*) and “outcome” [5]. While a plethora of other
Imperial College Healthcare NHS Trust, Department of quality of care frameworks have been proposed
Surgery and Cancer, St. Mary’s Hospitalm, Praed Street,
over the subsequent years, Donabedian’s work
London W2 1NY, UK
e-mail: [email protected]; remains the dominant paradigm over a quarter of
[email protected]; [email protected] a century later.

838 C. Pettengell et al.
While quality and safety have two distinct parison only 14.9 % of the population of HICs
definitions, there are considerable overlaps when lack access. This estimate is over double previous
applied to health care. It has been stated “high- reports [14] but is important when thinking about
quality systems are safe systems” and indeed, the the challenges facing LMICs in supplying safe
two concepts should not be considered mutually and effective surgical care as it recognizes that
exclusive [6]. These similarities are echoed in access is about more than capacity alone. It is the
the work of Provonost, and others, who have lack of timely, safe and affordable access that
developed models for patient safety that use results in the majority of the world’s population
Donabedian’s original quality paradigm as a having to forego appropriate surgical care.
skeleton structure [7–9]. In a similar vein, we A major hurdle then is that of national infra-
consider the facets of quality and patient safety structure to enable patients to reach the hospital
under the headings of Donabedian. in a timely manner. We know that where appro-
priate surgical and intensive care facilities exist
these can prevent morbidity and mortality in the
Structure sickest patients however, these patients are often
presenting late to hospital resulting in poor out-
The term “structure” is better phrased as “infra- comes [15]. The reasons for this are complex and
structure” as it comprises all the physical equip- multifaceted since not only are health care facili-
ment, levels of staffing, training and, obviously, ties in LMICs often vast distances away from
the financial situation of a health care system. where patients require them but those that are
Since it measures finite, definite things, it is eas- able to reach the door of the hospital can find
ily quantifiable and is seen as the base upon lengthy queues ahead of them owing to over-
which other components of quality build. It is crowding, poor facilities, and a lack of adequately
also something that, we, as practicing surgeons in trained staff [16, 17]. In the face of limited
high-income countries (HICs), take for granted. resources and huge demand, providing high-
Globally, the greatest burden of surgical dis- quality care is extremely challenging [18].
ease is found in low-income and middle-income Patients are often also discouraged from seek-
countries (LMICs), yet these countries are exactly ing surgical care due to the direct and indirect
those whose infrastructure is often severely lim- costs associated with it. The World Bank esti-
ited. This is borne out when considering that while mates three billion people earn less than US $2.5
more than 200 million operations are performed per day which makes even modest hospital fees
across the globe each year, only 3.5 % are for the of US $133 unaffordable [16] added to this in
poorest third of the world’s population and there- some places the lack of hospital supplies requires
fore accessing surgical care remains a major chal- patients to provide their own [19].
lenge [10]. Indeed, it has previously been estimated For those that do access appropriate care it has
that approximately two billion people lack access long been recognized that outcomes are influenced
to an adequate level of surgical care [11]. by the complex interplay of multidisciplinary
The Lancet Commission on Global Surgery teams and the systems that they work within [20].
[12] defines access to surgery in any country as At its simplest level this can be broken down into
the existence of four components, capacity in four parts: the staff, the equipment, the buildings
terms of staff and infrastructure and ability to they use and the systems that allow the staff and
access it in a timely, safe and affordable way. By equipment to effectively work together in the
applying this stepwise model to the global popu- shared space [13]. Access to all of these compo-
lation it is possible to estimate the probability nents is limited in resource-poor settings and will
that an individual has access to surgical care. therefore impact on a nation’s ability to provide
Unbelievably the Commission found at least 4.8 effective surgical care to its population.
billion people do not have access to surgery In many LMICs the equipment and space to
worldwide, a figure that represents almost 95 % work is woefully inadequate. An analysis of the
of the population of many LMICs [13]. By com- number of operating theaters available in 792 hos-
50 Global Surgery: Progress and Challenges in Surgical Quality and Patient Safety 839
pitals participating in the WHO’s safe surgery it also requires a large body of willing volun-
saves lives campaign showed gross disparities [14]. teers—though surveys confirm that there are
Low-income countries, which accounted for over increasing numbers of surgeons and surgical
2.2 billion people, had on average less than two trainees from HICs, especially those from Europe
theaters per 100,000 people and in the worst and North America, expressing a desire to pro-
affected, such as west sub-Saharan Africa, only one vide such services in LMICs [26].
operating theater per 100,000. Compare this with Many of the international organizations pro-
the global average of 14 or 25.1 per 100,000 in viding surgical care in LMICs do so in response
Eastern Europe and you get an idea of the scale of to acute health care crises: as a result of natural
the problem. Even if a patient is fortunate enough disasters, conflict, famine, or sudden disease out-
to have access to an operating theater around breaks. This generates considerable overlap
77,700 of these worldwide do not have access to between the “routine” work these organizations
basic equipment necessary to provide safe surgical provide and more wide-ranging acute humanitar-
care such as pulse oximetry [14]. ian relief projects. It is difficult to fully appraise
Basic infrastructure gaps such as unreliable elec- the burden of surgical disease treated by such
tricity and water supplies will further hamper efforts mission work as there is little by way of data
and impact on outcomes [15]. In 12 sub-Saharan reporting outside of their organizations [27].
countries reliable electricity was fully available in However, a recent survey across 99 such organi-
only 35 % of health facilities [21]. In Sierra Leone zations showed provision of care across the entire
the situation is even direr with a lack of electricity, breadth of surgical specialties though it also
running water, oxygen and fuel at the government revealed considerable variation as to the scale of
run hospitals, only 20 % had running water [19]. care provided—with a third of organizations per-
The final barrier limiting access to surgical forming less than 200 operations a year and only
care is a drastic shortage of trained surgical pro- five performing more than 1000 surgeries [28].
viders, with general surgeon density ranging from One of the largest of these international organi-
0.13 to 1.57 per 100,000 population in LMICs zations is Médecins Sans Frontières (Doctors with-
[22], contrasting with an equivalent figure of 5.8 out borders, MSF) which, despite being a
per 100,000 population in the USA [23]. French-based organization, recruit surgeons inter-
Recent estimates suggest that, by 2030, an nationally and coordinate projects both in response
additional 806,352 surgical providers will be to emergency crises and in other areas of desperate
required in LMICs [24]. This is an ever worsen- need [29]. Over four decades, MSF have provided
ing surgical workforce crisis and somewhat cru- surgical care in Afghanistan, Angola, Cambodia,
cially, the question remains as to how this can be Chad, Ethiopia, Haiti Libya, Sierra Leone, Somalia,
solved. Current approaches have broadly been and Sudan to name but a few, and in 2006 alone
either short term humanitarian based projects or they performed over 64,000 procedures across 20
“missions” (where international surgeons from countries worldwide [30].
HIC provide work in LMICs) or, more challeng- While the efforts of HIC surgeons on these
ing, longer term projects focused on increasing short-term missions have undoubtedly improved
levels of training for both existing and new the lives of countless individuals in LMICs, their
practitioners. ability to confer any long term effects on the
actual infrastructure within these countries is
somewhat more limited [31, 32]. Some authors
HIC Surgeons Practicing in LMICs have also expressed concerns that, as the cost of
health care worldwide continues to increase, that
An estimated 55 % of all surgical care in LMICs the funding needed by these charitable organiza-
is delivered through international charitable orga- tions will increase concurrently and that there is
nizations and, for the years 2008–2013, this therefore an acute need to move towards sustain-
required funding to the tune of $3.3billion [25]. able health care in LMICs—without such a reli-
Not only does this require considerable financing ance on international aid [33].
Enhanced Training for LMIC Surgeons also increase opportunities for surgeons working
in LMICs, further increasing workforce retention
The majority of long-term projects have taken a and going against the clinician “brain drain” cur-
particular interest in workforce initiatives to rently seen all too frequently within these coun-
expand surgical and perioperative training for tries [40, 41].
surgical providers in LMICs. Much progress on It has been suggested that if the WHO publish
this front has been made since it has been adopted surgical workforce data (in the way it already
by the World Health Organization (WHO), does for other specialities within health care), to
though there are some who have chastised the allow recognition of the global shortfalls in surgi-
WHO for not recognizing the inadequacies of cal personnel as only by delineating the problem
surgical care in LMICs until this point [34]. can we begin to plan and direct targeted initia-
In 2004, the WHO launched the Emergency tives in the future [22].
and Essential Care Programme. This program pro- Unfortunately, the dearth of qualified sur-
vides a basic training package for surgical provid- geons and anesthesists is not the only problem
ers in LMICs based around the Integrated faced globally. Another neglected issue is the
Management of Emergency and Essential Surgical lack of equipment to permit surgical practice in
Care toolkit and the text “Surgical Care at the many LMICs. Simply increasing the funding for
District Hospital” [35, 36]. A key facet of this health care in these settings is not a viable
project is a strong emphasis on “Training the train- option in most circumstances and so we must
ers” courses, where local staff are empowered to approach this problem more creatively to find
propagate this training program elsewhere, lead- more innovative solutions. This is what provides
ing to large scale dissemination. While the avail- the catalyst for frugal innovation.
ability of longer term data is limited by the
implementation date of the programme in individ-
ual settings, Henry et al. reported its impact within Frugal Innovation
Mongolia over a 6-year period, noting its adoption
in over half of all health care centers during this Increasingly, there is a recognition that the dis-
time and a conferred 74 % increase in the number semination, or “flow,” of ideas does not have to
of emergency procedures performed [37]. be one-way traffic from HICs to LMICs. The
The WHO is also able to lead on aims to concept of reverse of frugal innovation is a rela-
improve infrastructure through its influence on tively new one within the sphere of health care,
global health policymakers and the coordination where we often tend to focus on the refinement of
and integration of stakeholders at multiple levels established practices in developed countries with
within LMICs, including the relevant Ministry of a trickle-down effect to the developing world, but
Health, international partners and non-government it has been an accepted phenomenon within other
organizations [34]. The clearest path to long-term fields for some time [42].
solutions is through sustained dialogue and col- LMICs are continually seeking to expand and
laboration within each country. improve the quality of health care for their popula-
Those in HICs can also have an effect on the tions but they do so under considerable restraints
number of trained surgeons in LMICs through in terms of physical and financial resources. The
international recruitment strategies. Indeed, the coupling of these limited resources with their,
net shortage of 4.3 million health professionals often acute, health needs drives innovation at
across 57 LMICs prompted the WHO to issue a levels not seen in HICs. Furthermore, often
formal code of practice for the responsible working from a blank slate, without an established
recruitment of health care workers by HICs [38]. health care framework, they can be considered
What health care organizations in HICs must freer to experiment and innovate [43].
rather do is establish links with their counterparts There are countless occasions one can recall
in LMICs for the exchange of training and expe- where surgical equipment we now see as common-
rience [39]. Collaborations such as these would place was conceived by colleagues working under
the confined of restricted resources. For example, action that a patient could be exposed to during
the use of a polyethylene urine bag to temporarily their health care episode, including unsafe care.
cover large laparostomy wounds was first employed
by Borraez in 1984, while working in a hospital in
a deprived area of Bogotá, Columbia [44]. The use urgical Quality Improvement
S
of the “Bogotá bag” for abdominal wall closure is in LMICs
now a recommended technique and is considerably
cheaper than alternate methods [45]. Changes in these processes, usually referred to as
The city of Bogotá was also the birthplace of exercises in quality improvement, should confer
another frugal surgical innovation in the creation downstream beneficial changes in measured out-
of the first unidirectional valve for the drainage of comes. It is important that we define processes in
cerebrospinal fluid in patients with normal- terms of their associated outcomes as they are
pressure hydrocephalus by Hakim [46]. As with what allow us to quantify the effect of a given
the Bogotá bag, this device can also be produced improvement initiative. Quality improvement
at low cost and, indeed, the Indian company (QI) itself is a term becoming increasingly com-
Surgiwear produces the Chhabra Micro Precision monplace in health care parlance. One of the best
ventriculo-peritoneal shunt system, based on the definitions of QI was phrased by Batalden and
original Hakim mechanism, for only $35 [47]. Davidoff who state QI is the:
Ilizarov developed his eponymous frame for … combined and unceasing efforts of everyone—
the external fixation of a fracture while working healthcare professionals, patient and their families,
as an orthopedic surgeon in a remote part of west- researchers, payers, planners and educators—to
ern Siberia in the 1950s with very limited make the changes that will lead to better patient out-
comes (health), better system performance (care)
resources [48]. It was only some 25 years later, and better professional development (learning) [52].
when Ilizarov present his work at a conference in
Italy, that his frame began to be adopted by sur- This, and in essence all definitions of QI, views
geons globally and it continues to be utilized in health care as a series of processes within a sys-
operative fracture management today [49, 50]. tem. The isolation and fine-tuning of these pro-
These are but three of the innovations con- cesses is what QI is principally concerned with.
ceived and developed in the context of subopti- QI has long been accepted as a vital part of the
mal resources. Each was designed to meet a manufacturing industry and a number of specific
specific need and by the simplest, and so cheap- methodologies have been developed in this sector
est, way possible. Not only are such frugal inno- to reduce variation and error while increasing
vation low cost but also they are often more reliability, thus improving not only quality for the
suited to their environment, utilizing the materi- customer but reducing cost for the manufacturer
als or resources that are present. More work is [53]. Many of these methodologies have been
needed to make sure that frugal innovations can adopted by the health care sector including:
be recognized and their benefit shared among the
health care providers that need them the most. • Plan-Do-Study-Act (PDSA) cycles, which
A current project, based in the USA and consist of four stages in an iterative cycle.
supported by the Commonwealth Fund is In the “plan” stage the change for improve-
attempting to advance this very issue and we ment is determined, the “do” stage comprises
await its results eagerly [51]. the testing of this change, the “study” stage
examines the effects of the change, in compari-
son to what was before, and the “act” stage
Process analyses these difference to inform a further
cycle of improvement [54, 55]. PDSA cycles
“Process” refers to the actions of health care have been used successfully in endovascular
delivery itself, including not only all diagnostics surgery to reduce atrial closure complications
and treatment but also every conceivable event or in the UK [56], and in trauma surgery in a large
study to reduce operative waiting times in Excellence (SQUIRE) which will permit more
Finland [57]. rigorous assessment [68].
• Six Sigma (SS) was developed by the Motorola As discussed above, the principal issue affect-
Corporation in the USA in 1986 and aims to ing quality in many LMICs is a lack of access to
generate QI through the identification and cor- adequate surgical care and other problems relat-
rection of errors at source—to reduce the rate ing to the existing health care infrastructure. This
of errors to a six sigma level of 3.4 defects per does not, however, mean that improving the pro-
million opportunities. SS methodology has cesses within the health care system in LMICs is
been used to reduce morbidity in rectal cancer not an ongoing challenge.
surgery in India [58], to reduce infection in the There is evidence that a raft of QI projects
surgical ICU in the USA [59] and to improve take place within LMICs, especially within the
efficiency in theater in both the Netherlands topic of trauma care, but there is a recognized
and the USA [60, 61]. need to strengthen system improvements in these
• Lean methodology evolved from the Toyota settings [69].
Production system in 1988 and is a continual Qualitative research, carried out among surgeons
QI process where all sources of waste from a practicing in LMICs, has suggested that that the first
process are systematically eliminate, leaving priority should be to move towards standardized
only the steps which confer value [62]. outcome data collection, to establish current quality
Published studies successfully utilizing baselines and thereby allow the impact of subse-
Lean methodology in surgery include a signifi- quent QI initiatives to be assessed [70, 71].
cant reduction in mortality in patients with frac- Given that many health care professionals in
tured neck of femur following introduction of LMICs have differences in exposure to the field
Lean academy meeting and the standardization of QI and development [69], we must also look to
of care with dedicated daily theater slots [63]. increase training in this field and promote aware-
ness of QI, especially among hospital leadership
It should be noted that, despite numerous success levels [70, 71].
stories of QI methodologies from the manufac- To further advance this cause, the establishment
turing industry conferring benefit when applied of formalized working-groups, such as the Asia-
to processes in surgery, the results of each are Pacific Trauma Quality Improvement Network
context dependent and so it is not possible to (APTQIN), can only further elevate the QI on the
make definitive evidence-based recommenda- agenda within LMICs [70].
tions. Recent systematic reviews exploring the
impact of PDSA, SS and Lean methodology
make reference to the striking heterogeneity I mplementing Surgical Safety
between different interventions preventing any Processes in LMICs
kind of meta-analysis of data [64, 65].
While there is considerable evidence to support The challenges to reducing adverse events in
the use of QI methodology in health care, we LMICs are substantial. They face all of the diffi-
should recall that the initial step in any QI project culties found in HICs, where there has been only
is a full and thorough determination of the pro- limited improvement and avoidable adverse
cesses and systems already in place locally [66]. events remain a persistent problem [72]. In addi-
Thereafter any innovation, no matter its strategy tion LMICs lack essential resources and have dis-
should, ideally, be configured specifically for the proportionately low levels of funding for health
setting in which it will be implemented [67]. The services research, which further exacerbates
limitations encountered when reviewing reports of financial difficulties. There is an assumption that
QI in the peer-reviewed literature have been noted access to care and basic public health issues
previously and it is hoped that future reports con- remain the most pressing needs of low-income
form to standardized reporting frameworks, such countries. This explains why over the decade
as Standards for QUality Improvement Reporting between 1998 and 2007 the Bill and Melinda
Gates foundation awarded 36.5 % of its total fund- fied challenges to implementing the checklist in
ing to basic science research and 24.1 % on health these settings including infrastructure, resources,
care delivery but only 4.7 % on health services safety culture, and social norms. For example, in
research [73]. While lack of access is of course a Thailand, lack of equipment affects the use of pulse
priority and will cause significant harm the safety oximeters and surgical site marking [78]. This is
of the care being offered must not be overlooked. also impacted by the societal norm that you should
To address this ongoing issue the WHO have not make a mark on another person. Similarly, in
launched several campaigns focused on patient Thai culture people only introduce themselves upon
safety. The most well known of these is the “Safe first meeting and are reluctant to do so subsequently
Surgery Saves Lives” which not only assessed the which impacts on surgical team members introduc-
global volume of surgery and issues with access, ing themselves during the timeout period [78].
but developed the Surgical Safety Checklist (SSC) When tackling these local issues, particularly
[74]. This came from an understanding that in LMICs, it is important to develop focused
merely implementing protocols from high-income solutions, which may require the modification of
countries was unlikely to improve patient safety the SSC, training and feedback, all while taking
and so was devised by a group of clinicians from cultural variations into account. A team in
around the world, representing the full range of Uganda was able to increase the compliance rate
environments in which surgery is practiced. from 29.5 to 85 % with relatively simple inter-
This team, led by Dr. Atul Gawande, was ventions of a stepwise incremental change and
faced with the challenge of how to devise a low- standardizations of practice to address societal
cost, universally applicable intervention to reduce and cultural norms [79]. PDSA cycles informed
the harm associated with surgery. Taking inspira- regular structured feedback to generate improve-
tion from other industries such as aviation [75] ment in health care through changing the local
and construction they developed a checklist to behaviors. They were able to do this with
prompt routine checks at three critical stages in minimal external input and instead relied on

the operation: before the induction of anesthesia strong local leadership and staff engagement
(sign in), before the skin incision (time out) and with the project. Understaffing and lack of equip-
before the patient leaves the operating room (sign ment remain challenges and areas where external
out). The checklist was trialed in eight hospitals input by way of training programs and funding
around the world and reduced errors and conse- would be beneficial.
quently improved outcomes. Mortality overall A recent interview study with surgeons from
fell from 1.5 to 0.8 % and complications fell from both HICs and LMICs (within an international
11 to 7 % following implementation of the SSC collaborative of surgeons working in LMICs) sug-
[76]. These figures included both HIC and LMIC gested that, while the majority of surgeons
and the effect was even greater when low-income expressed an emphasis on cultural sensitivity and
sites were looked at in isolation [76], which respect for local traditions, they also highlighted a
would suggest that the SCC is particularly useful need to change the existing surgical culture within
and relevant to LMIC where it has the greatest LMICs [80]. Proposed changes included increased
impact. Unlike HIC where operative lists are lim- personal accountability and responsibility, greater
ited and surgeons subspecialize; in LMIC sur- advocacy for patients and the introduction of mor-
geons may have to perform higher numbers of tality and morbidity meetings to foster an environ-
operations that are not in their areas of expertise. ment of healthy reflection and learning [80].
In these settings it is perhaps not surprising that Fostering a healthy culture within a health care
simple steps are forgotten given the increased system has been described as “the key to quality
workload and lack of familiarity. improvement” [81], but discussions around health
Despite the remarkable success of the WHO care culture and organizational health can be
SSC its usage worldwide remains as low as 12 % in challenging since both are abstract constructs
some studies [77] and there is clearly room to which can be complex to define, before one even
improve compliance. Studies in LMIC have identi- considers their measurement with any degree of
certainty. That being said, the need to forge a ity data such that the research was only able to look
healthy and productive organizational culture has at seven different adverse events despite having
long been recognized in the world of business and previously identified 20 topics of importance to
can be found in the management literature as far patient safety. They were unable to include clini-
back as 1958 [82]. Healthy organizations have a cally important and common adverse events related
culture promoting trust, openness and engagement to surgery due to the paucity of data available. The
and enabling continuous learning and improve- GBD from just these seven adverse events ranked
ment [83]. The link between healthy organiza- unsafe medical care as the 20th leading cause of
tional culture and health care quality and patient DALY loss worldwide. Furthermore, when includ-
safety is being increasingly recognized and it is ing estimates for unsafe injection practices the
something that all health care providers, globally, resultant GBD would be placed as 14th, compara-
can look to in the future to imprint long term high- ble to tuberculosis or malaria [85]. Thus prevent-
level care [84]. able adverse events are a leading cause of morbidity
and mortality worldwide.
While measuring the outcomes of surgery can
Outcomes be straightforward as an exercise, being able to
establish causality between specific processes and
“Outcome” relates to the downstream effect of outcomes can often prove fraught with difficulties,
health care delivery and so can be considered a requiring large sample sizes and c onsiderable time
more intuitive indicator of quality and safety. periods of observation [86]. Indeed, the recogni-
Unfortunately, within LMICs the challenges are tion of a need for outcome monitoring has
not just related to access to surgical care but also increased dramatically over the last few decades.
unsafe care—where patients are harmed by the We have come a long way since the turn of the
care they receive—is a major cause of poor patient twentieth century when Ernest Codman, a surgeon
outcome. This also generates waste in an already then based at Massachusetts General Hospital,
poorly resourced setting and will affect patient vocalized his ideas around the collection of patient
confidence in the system. In these settings it is outcomes for quality improvement purposes [87].
suggested that patients may even opt out of formal While his ideas were originally shunned, now, a
health care systems, thus creating a further barrier century later, those of us practicing in HICs find
to accessing surgical care. For these reasons ourselves inundated with an incredible range of
patient safety is not just an issue for HIC although datasets on surgical quality and safety. Determining
the degree to which unsafe medical care is a prob- the value, and indeed limitations, of specific data-
lem for developing countries is not well known. sets and the extrapolations that can than can be
The WHO has estimated the global burden of made from each can remain a daunting task.
unsafe care for both high and low-income countries The challenge now is to develop methods of
using disability adjusted life-years (DALYs). This data collection that will identify the different needs
provides a standard metric with which to compare and priorities that LMICs have when trying to
how much suffering is caused by a specific disease improve patient safety. Simply adopting best prac-
or other public health danger such as road traffic tice from HICs is unlikely to address the underly-
accidents. The global burden of disease (GBD) can ing causes and may even cause harm. Given that
be used by policy makers at all levels to direct resources are lacking, these methods need to be
funding and resources. The WHO’s estimates sug- inexpensive and therefore should be independently
gest that there are approximately 12.7 adverse assessed for their cost-effectiveness.
events for every 100 hospitalizations in low-income Since the Harvard Medical Practice Study in
countries which is 25.9 million per year. This 1991 [88] unsafe care has been extensively stud-
equates to 15.5 million DALYs lost per year in ied in high-income countries. This was based on
these countries, the majority of which were due to a retrospective case note review and identified the
premature death [85]. These estimates, however, incidence of adverse events in New York State
are limited by the lack of availability of high-qual- hospitals. An adverse event is defined as an unin-
tended injury or complication caused by health current inpatient case note review, staff interviews,
care management, rather than the disease pro- nominal group meetings and direct observations
cess, leading to prolonged admission, disability across 13 different countries. The key was to
at discharge or death [88]. An error is the failure assess how relevant, feasible, acceptable, and valid
of a planned action to be completed or the use of the tools were. Following this they produced a
a wrong plan to achieve an aim and may be errors “Methodological Guide for Data Poor Hospitals”
of commission or omission [89]. These need not to allow institutions to choose which method is
necessarily cause harm and are therefore distinct most suitable to meet their individual needs includ-
to adverse events. Some literature refers to these ing the availability of good quality medical records
as potential adverse events [90]. and to facilitate its use and understanding [92].
Measuring these events is challenging and even
Codman was subject to criticism for his methods,
predominantly as his data did not account for vari- Conclusions
ation in case-mix. Data collection requires a robust
infrastructure and well-defined metrics to measure Many global health improvement efforts in LMICs
outcomes. Although retrospective case note review focus on infectious disease, maternal and neonatal
has been the most widely used methodology for disease and nutrition [93]. However, access to
assessing harm in HICs there are many other safe, affordable surgical care is essential for a
methods including incident reporting or clinical “functional, responsive and resilient health care
surveillance, routine administrative data, malprac- system” [12]. Furthermore surgical care is now
tice claims and national or regional audits. accepted to be cost-effective relative to other med-
LMICs do not routinely have access to much ical interventions when it can be applied safely
of the data required for these methods because of and effectively [77]. Unfortunately accessing sur-
the variation in the detail and quality of the case gical care in LMICs remains a major challenge
notes. Furthermore current strategies employed due to severe limitation in infrastructure at multi-
in HIC such as clinical surveillance, observation ple levels. Further challenges exist around issues
of patient care and retrospective chart review are of appropriate staffing, and a lack of funding
expensive and require trained observers [91]. A which remains the largest hurdle for the majority
lack of trained personnel affects not just access LMICs. The engagement and involvement of a
and ability to deliver safe surgical care but also a number of international organizations has been a
health care system’s ability to adequately assess welcome boost for many patients in LMICs but
outcomes. Alternatives including administrative long-term sustainable strategies are required to
data analysis and electronic medical records are meet spiralling health needs.
equally unfeasible because of high implementa- The ability of LMICs to implement interna-
tion costs and rudimentary medical record sys- tional, well-validated programs given these chal-
tems. Finally strategies such as malpractice lenges is not clear but studies have not been
claims analysis and national or regional audits do optimistic. It is suggested that less that 2 % of
not have equivalents in LMICs. providers in Africa have the resources available
To address this, the WHO have studied whether to implement some international health care
standard retrospective case note review was feasi- guidelines [94]. There are clearly severe short-
ble in LMICs and found that while it is possible it ages in all aspects of access for the populations of
is only useful in the main flagship hospitals of LMICs and these will not be filled with generic
these countries. Elsewhere, the cost, organization, efforts or guidelines. In these resource-poor set-
and limited information contained in the notes tings targeted or modified solutions need to be
made the methodology unsuitable. Having identi- devised to achieve safe and affordable surgical
fied a need for new methodologies they developed care when needed. There are a number of success
modified tools for research into unsafe care in hos- stories we make reference to in this chapter, and
pitals with low resources and variable data quality their progress should not go unmentioned, but
[92]. They tested retrospective case note review, without the coordinated efforts of all invested
parties to improve capacity, infrastructure, and 16. Grimes CE, Bowman KG, Dodgion CM, Lavy

CB. Systematic review of barriers to surgical care in
ability to access it in a timely, safe, and afford-
low-income and middle-income countries. World
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are scarce? BMJ Qual Saf. 2015;24(7):432–4.
18. Wall AE. Ethics in global surgery. World J Surg.

2014;38(7):1574–80.
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International Perspectives
on Safety, Quality, and Reliability 51
of Surgical Care
Sertaç Çiçek and Hişam Alahdab
“Surgeons can cut out everything except cause.”

—Herbert M. Shelton
have demonstrated that the increased cost for

Background complications was $1398, $7789, $52, 466, and
$1810 for infectious, cardiovascular, respiratory,
It is universally accepted that safety and quality are and thromboembolic complications, respectively.
critical dimensions in the provision of surgical care. More importantly, Khuri and colleagues demon-
Evidence shows that services that are unsafe and are strated that, independent of preoperative patient
of low quality lead to diminished health outcomes, risk, the occurrence of a complication 30 days in
increased cost and more importantly harm to the duration reduced the median patient survival by
patient. Surgical interventions have continued to be 69 % [6]. Among the most common complica-
the gold standard treatment for many disease pro- tions after surgery are surgical site infections
cesses. It has been estimated that one operation is (SSI), postoperative sepsis, respiratory, cardio-
being performed on every 25 person alive and over vascular, and thromboembolic complications. It is
234 million operations are performed annually evident that most of these complications are pre-
worldwide [1]. Although millions of lives are being ventable in nature by applying safety science and
saved by surgery, surgical outcomes vary widely the well-established standards of care [3, 4, 7].
across hospitals, surgeons, and countries [2]. Up to Considering the over 200 million surgical proce-
30 % of patients undergoing surgery have been dures performed each year globally, even small
reported to have either minor or major complica- improvements would be associated with substan-
tions ending with unwanted outcomes [3, 4]. tial savings at the population level. Although
Patients who experience surgical complications clear data regarding surgical complication rates
have increased hospital length of stay, readmission, are available in industrialized countries, this is
morbidity and mortality rates. Dimick et al. [5] not the situation for developing countries and
there might be a lot of room for improvement that
could save lives with only simple measures.
Many quality improvement projects have been
S. Çiçek, MD, FACC, FCCP (*)
Center for Heart and Vascular Care, Anadolu Medical launched worldwide aimed at reducing surgical
Center, Cardiovascular Surgery, Anadolu Caddesi, complications and providing safe surgery. In
Bayramoglu, Istanbul 41400, Turkey 2008, the World Health Organization (WHO)
created an initiative and published guidelines
H. Alahdab, MD, FCCP identifying multiple recommended practices to
Anadolu Medical Center, Pulmonary Diseases,
ensure the safety of surgical patients worldwide
Anadolu Caddesi, Bayramoglu, Istanbul 41400,
Turkey [8]. This broad-based initiative defines ten essen-
e-mail: [email protected] tial objectives for safe surgery (Table 51.1).

850 S. Çiçek and H. Alahdab
Table 51.1 Essential objectives of safe surgery high and there are significant opportunities for
• Correct patient, correct site operation prevention [11].
• Avoiding harm related to anesthesia while Surgical site infections (SSI) continue to
controlling pain represent a significant portion of health care-
• Recognition and effective preparation for life- associated infections. The SSI rate in developed
threatening loss of airway or respiratory function
countries is around 1–3 % for elective clean sur-
• Recognition and effective preparation for risk of
high blood loss gery [12]. However, some limited data available
• Avoidance of known allergic and adverse drug from developing countries shows a SSI rate rang-
reactions ing from 1.2 to 23.6 % and higher [12, 13]. Patients
• Minimizing the risk for surgical site infection with SSI infections have a higher mortality and an
• Prevention of foreign body retention in surgical increased length of stay in the hospital and in the
wounds ICU and higher risk of hospital readmissions. The
• Accurate identification of all surgical specimens impact on morbidity, mortality, and the cost of
• Effective communication of critical information
care has resulted in SSI reduction being identified
necessary to conduct a safe surgery
• Routine surveillance of surgical capacity, volume
as a top priority worldwide. The majority of SSIs
and results by hospitals and public health systems are largely preventable and evidence-based strate-
gies have been available and implemented in many
hospitals, as recognized by the SCIP and Society
Health quality improvement programs focused for Healthcare Epidemiology of America (SHEA)
on these ten simple and easily attainable objec- in the US. Worldwide attention to safer surgery
tives may be an effective strategy for improving including the prevention of SSI led to the develop-
patient care and reducing cost globally. This ment of the WHO Surgical Safety Checklist dem-
chapter aims to address surgery related safety and onstrating the importance of teamwork and
quality issues from the international perspective communication in addition to evidence-based care
and shed light on the best practices for prevention for preventing SSI. With the SSIs becoming an
and mitigation of surgical risks. integral issue of patient safety not only in the
operating room, but also up to hospital discharge
and beyond; multimodal, multicenter or global
How Safe Is Surgical Care? preventive intervention programs based on guide-
lines, bundles or safety checklists are gaining
Despite major advances in surgery, anesthesia momentum on a global scale [13]. Table 51.2 lists
and improvements in perioperative care, patients the WHO recommendations to prevent SSIs. Some
continue to have variations in their surgical out- other recommendations include effective hand
comes [5]. The incidence of postoperative com- hygiene throughout the care period, smoking ces-
plications ranges from ∼6 % for patients sation 30 days before surgery, optimal glycemic
undergoing noncardiac surgery to >30 % for control of diabetic patients during the periopera-
patients undergoing high-risk surgery [9, 10]. tive period and active surveillance for SSIs.
When surgeons are asked, if they practice safe Growing evidence demonstrated that surgical hand
surgery, the unanimous answer will be “yes”; hygiene upon coming to the operating room ranges
however, the definition of “safe” surgery will from 3 to 10 % [14]. These interventions do not
most likely vary for each, and it is out of scope of require new and sophisticated technology. An
this chapter to address the whole range of surgi- improved adherence to established basic princi-
cal safety and quality issues. We focus on four ples such as surgical hand preparation, skin anti-
broad areas as suggested by the surgical care sepsis, adequate antibiotic prophylaxis, less
improvement project (SCIP): prevention of SSIs, traumatic, less invasive and shorter surgery dura-
prevention of adverse cardiovascular events, pre- tion, improved hemostasis and avoidance of hypo-
vention of venous thromboembolism, and pre- thermia or hyperglycemia will remain cornerstones
vention of respiratory complications. The for SSI prevention. Raising awareness at different
incidence and cost of complications in surgery is levels, including local/national authorities and
51 International Perspectives on Safety, Quality, and Reliability of Surgical Care 851
Table 51.2 WHO recommendations to prevent SSIs Venous thromboembolism (VTE) occurs in
• Prophylactic antibiotic usage ∼25 % of all major operations if appropriate
• Robust sterilization process for surgical instruments prophylaxis has not been started and almost a
• Redosing of prophylactic antibiotics when needed one-fourth end up with pulmonary embolism
• Discontinuation of prophylactic antibiotics after 24 h which appears as sudden death [18]. Cohen et al.
• Avoiding hair removal unless it interferes with the found that nearly three quarters of VTE-related
operation technique. If needed clipping rather than
deaths were from hospital acquired thrombosis,
shaving should be practiced
• Meeting the individual requirements of oxygen for
but only seven percent were diagnosed ante-mor-
each patient during the perioperative period tem; 34 % were caused by sudden fatal PE, and
• Maintaining normothermia through the 59 % were undiagnosed pulmonary embolism
perioperative period [19]. In a recent report, VTE associated with hos-
• Skin preparation with appropriate antiseptic pitalization, in addition to increased hospital
solutions before incision costs, was the leading cause of disability-adjusted
• Surgical hand antisepsis by scrubbing the hands and
life-years in low-income and middle-income
forearms for 2–5 min using antiseptic soap and
water countries, and the second most common cause in
• Covering the hair of the operating team and wearing high-income countries [20]. Surgical procedures
sterile gowns and gloves associated with a high risk of VTE include neuro-
surgery, major orthopedic surgery of the leg,
renal transplantation, cardiovascular surgery, and
thoracic, abdominal, or pelvic surgery for cancer.
especially inviting the public to assist, may trigger Obesity and poor physical status according to
efforts for reporting SSIs and international bench- American Society of Anesthesiology criteria are
marking, and possibly contribute towards a further risk factors for VTE after total hip arthroplasty
decrease of current infection rates. This goal [21]. Observational studies continue to report
requires multidisciplinary, multifaceted commit- underuse of prophylaxis for postoperative pul-
ment, dedicated infection control teams and monary embolism/deep vein thrombosis despite
efforts, and institutional and behavioral elements, the long- standing evidence-based guidelines
all of which could be achievable with education, [22]. The Institute of Medicine considers failure
determination and minimal cost. Active and direct to provide appropriate VTE prophylaxis to hospi-
feedback is at least equally as effective in reducing talized at risk patients a medical error, and yet the
SSIs without even further precautions. In 1985, the use of prophylaxis is nonuniform and often varies
Study on the Efficacy of Nosocomial Infection by physician within a given institution, leading to
Control (SENIC) demonstrated that the presence variability in types and complication rates. A
of a dedicated infection control team, together VTE prophylaxis protocol was implemented at
with surveillance and feedback of observed data to Anadolu Medical Center in 2011 to decrease
the team, resulted in a 38 % decrease of SSIs VTE complications, based on standardized
among participating hospitals [15]. However, this electronic physician orders that specify early

required not only implementing a structural mech- postoperative mobilization and mandatory VTE
anism but as also a behavioral and cultural change risk stratification for every patient, using the
package of interventions which were deployed “Caprini” grading system [18]. The derived
gradually and after deep consultation. Another scores dictate the nature and duration of VTE
speculative issue is will public/mandatory report- prophylaxis. Both mechanical (pneumatic com-
ing of outcomes and transparency initiatives influ- pression boots) and pharmacologic prophylaxis
ence SSI incidence [16]. The supporting data for (unfractionated or low molecular weight heparin)
such public reporting benefits are scarce and a are used, as indicated by risk level. Data has been
recent review could not identify any studies show- analyzed every 3 months, feedback was given to
ing public reporting benefits that investigated SSI physicians individually and adherence rate to
reduction as an outcome, as well as compared VTE prophylaxis protocol was defined as a
associated costs [17]. performance criteria. The adherence rates to VTE
prophylaxis protocol for low, medium, high, and associated with these events make prevention an
very high risk groups were 51, 67, 47, and 41 %, important priority and has been the subject of
respectively, for 2011 and 79, 81, 71, and 87 %, many quality improvement projects [28]. Many
respectively, for 2012. The total adherence rate to recent studies suggest that perioperative use of
protocol increased from 48 % in 2011 to 76 % in beta blockers may reduce risk of adverse cardio-
2012 and reached to a record breaking 98 % in vascular events in patients undergoing surgery
2015. With the increasing number of sicker [27–29]. Evidence from these papers has led to
patients and more complex procedures augment- initiatives for cardiovascular adverse event pre-
ing the risk of postoperative VTE, there is a clear vention becoming a priority.
need to establish and implement risk assessment Delivering surgical care is complex, complicated
tools and thromboprophylaxis guidelines in an and requires multidisciplinary collaboration, and
effort to curb rising rates of postoperative VTE. interdisciplinary action. Complicated procedures
Ventilator associated pneumonia (VAP) is and advanced technology increases complexity;
among the most common health care infections concomitantly, sophisticated organizational struc-
occurring in 9–27 % of all intubated patients and is tures emerge. All these factors make team-based
associated with significant morbidity and mortal- approach a necessity [30]. Many years of psycho-
ity [23]. It has been reported that between 10 and logical research in organizational behavior has
20 % of patients receiving >48 h of mechanical shown that individuals possessing high levels of
ventilation will develop VAP; critically ill patients expertise, technical knowledge and resources might
who develop VAP appear to be twice as likely to easily fail unless a teamwork environment is created
die compared with similar patients without VAP and maintained [31]. The essence of a multidisci-
and patients who develop VAP incur ≥ $10,019 in plinary team (MDT) is a common commitment,
additional hospital costs [23]. Considering the which in medical practice, amounts to the provision
huge economic and clinical burden and prevent- of optimal care by as many specialists as the indi-
able nature, lowering the incidence of VAP would vidual case requires, who not only are experts in
be an important goal to achieve patient safety. The their field, but communicate effectively among
National Quality Forum [24], and the Institute for themselves as well [32]. A team-based approach has
Healthcare Improvement 100,000 Lives Campaign become the standard of practice in fields such as
[25] were among the firsts to include VAP preven- oncology and organ transplantation, where it has
tion as a quality indicator. They used a so-called been observed that decisions made by MDTs are
ventilator bundle consisting of four key compo- more likely to conform to evidence-based guide-
nents: elevation of the head of the bed to 30–45°, lines than those made by individual clinicians [33–
daily “sedation vacation,” peptic ulcer prophy- 35]. These teams were established after evidence
laxis, and deep venous thrombosis prophylaxis. showed better outcomes and less variability in sur-
The bundle was an all-or-nothing measurement vival among participating hospitals. Kesson et al.
(process indicator). However, difficulties remain recently reported that introduction of teams provid-
in reporting and benchmarking VAP rates due to ing multidisciplinary care for the treatment of breast
very heterogeneous patient case mix, and variabil- cancer was associated with 18 % lower mortality at
ity in diagnosis and surveillance protocols. 5 years, compared with the outcomes in neighbor-
Adverse cardiac events such as myocardial ing areas, where similar patients were treated over
infarction and cardiac death are common compli- the same period of time [36]. In “Crossing the
cations of surgery occurring in 1–5 % of patients Quality Chasm: A New Health System for the 21st
undergoing noncardiac surgery, and in as many Century,” teamwork is recognized as an integral
as 30 % of patients undergoing vascular surgery part of medical practice, cited as essential in caring
[26]. These events are associated with increased for patients with complex problems, and strongly
mortality as high as 60 % per event, and result in recommended as a practice that must be created and
longer hospitalizations and high costs of treat- maintained [37]. These and numerous similar
ment [27]. The prevalence and high mortality examples provide convincing evidence that
MDTs strengthen the ability to provide higher qual- incorporate best practices and evidence based
ity and more efficient care. Although a multidisci- standards into medical schools and resident/
plinary heart team is considered a standard practice fellow training program curricula [43, 44].
in many countries, access to such care still shows
high variability among neighboring institutions
[38]. Such variability can definitely be reduced, if Cultural Barriers
not prevented altogether, by reinforcing a variety of
measures such as implementing joint learning and Health care providers come from different cul-
debriefing arrangements, linked reimbursement or tural and educational backgrounds and try to mix
bundle strategies, administrative policies, quality up and work as one team for the best of patients.
and transparency reporting guidelines [39]. The The difference in cultures might lead to problems
Public Hospitals Association (KHB) of Turkey related to communication during the care process
recently implemented an obligatory heart team [45]. It is not uncommon to hear surgeons say
decision for any elective myocardial revasculariza- “I’ve been doing it like that for years,” “this is
tion procedure. Concurrently, the Ministry of how we do it over here,” underscoring the deep
Health (MOH) started an appropriateness control set challenges to culture change and the chal-
program, in which all myocardial revascularization lenges leaders face in these organizations [46].
data are sent to a group of surgeons and cardiolo- The importance of standardized communication
gists who are blinded as to the data source with tools, care plans and written communication
feedback provided to the participating centers. The tools cannot be over emphasized [47]. Moreover,
final goal is linking of reimbursement to the appro- the diversity of cultural backgrounds of patients
priateness of the procedure. Although the program and their careers can have a significant impact on
is still in its infancy, it is well received and is being their needs, understanding and compliance with
closely monitored. One very important factor to medical and surgical care team instructions [52].
facilitate implementation of a multidisciplinary The social, cultural and psychological evaluation
approach is to educate patients and accept them as of each patient is essential to achieve optimal
members of the team during the decision making patient centered care [48].
process. This approach, in which the patient is at
the center of the clinical microsystem has been
shown to create many benefits and suggested Language/Communication Barriers
improved outcomes [40, 41].
Health care is highly influenced by widespread
globalization, migration and increased
Challenges in International Practice international travel. Minorities with language

barriers live in many places and care providers
Lack of Education should be equipped to meet the language needs
and address the communication barriers of such
Abundant data suggests wide variation in the patients who are particularly vulnerable for
training, oversight, assessment, and success of handover problems [49]. Interpreters should be
surgical training in different countries. Until widely available either in person or by phone to
recently most of the medical education and prevent misunderstandings [50].
training programs lacked the necessary education
to enable patient safety and clinical quality of
care. There have been many efforts in the recent Patient and Family Involvement
years to incorporate such education in the medical
curricula, but the vast majority of practicing phy- Evidence has shown that involving patients and
sicians have not undergone formal safety and their families in the decision making and all other
quality education [42]. There is an urgent need to critical steps helps to improve outcomes and
reduce adverse events and medical errors [51]. risk patients to not worsen their performance
Tools have been developed to be used in shared numbers, leading to problems with access to care
decision-making [52]. Educated patients can for complicated patients.
improve hand hygiene, correct any errors during
handoffs and participate actively in their own
identification and site markings [41]. Status Hierarchy Barriers
Surgical teams have inevitable hierarchical com-

Health Tourism and Travelling position and this is much more marked in prac-
tices outside the USA. This can easily lead to
The number of travelling patients seeking undesired outcomes. People might easily “fear”
health care in different parts of the globe is to speak up with overbearing surgeons and when
increasing. Health care providers have to cope something goes wrong will stay quiet due to con-
seamlessly with a versatile group of patients cerns about being censured [53]. The safety cul-
with different needs, cultures, and languages. ture should be established so as to encourage
The system should be ready to meet the needs team members to speak up and if need me become
and communicate well with them. Within this “whistleblowers” and raise the flag and stop the
segment of the market, the focus of patient operations when they feel there is something
safety is upon the institution or physician who missing or wrong [54]. This can be an effective
is carrying out the treatment. Although majority antidote the pervasive normalized deviance in
of institutions providing care continuously is surgical care [55]. This culture needs strong lead-
making efforts to meet highest quality and ership support and a commitment from the
patient care standards; lack of oversight and C-suite and board to a transparent culture of
transparency is an important challenge. safety and high reliability principles [7].
roblems with Benchmarking
P Culture of Safety
and Data Reliability
A safety culture is an essential platform and cur-
The main drawback in comparing and bench- rently for safe and reliable practice. The main
marking data in health care is the difficulty of principle of culture of safety is a just and fair cul-
validation. Involving third parties in data collec- ture that transparently explores and discusses the
tion and validation increases the reliability of warts and challenges along with celebrating the
data. Another challenge is the difficulty to homog- successes [56]. There is a need for a nonpunitive
enize the cases. Every organization has different approach where fingers are not pointed at people
case-mixes and it is difficult to compare those but the system is held responsible for creating
doing surgery for highly complicated patients to conditions for mistakes and efforts are made to
those doing the same surgeries for relatively sta- continuously improve the system to prevent harm.
ble ones. On the other hand with the development
of electronic systems and the support of informa-
tion technologies, data is being collected easily, Conclusions
but a pernicious twist: an obsession with numbers
arise. With the increasing trend of metrics linked Health care institutions continue to face challenges
and value-based reimbursements, the risk of the in providing safe patient care in increasingly com-
organizations working on improving their “num- plex and demanding technical, organizational, and
bers,” in effect gaming the system, rather than regulatory environments. Both high reliability the-
actually measuring and improving their real per- ory and clinical microsystems provide conceptual
formance has dramatically increased [39]. For and practical frameworks for approaching the
instance, surgeons might prefer to operate on low delivery of safe care. This chapter explores the
applicability of high reliability and microsystems 3. Gawande AA, Thomas EJ, Zinner MJ, et al. The inci-
dence and nature of surgical adverse events in Colorado
theories to the surgical environment. Safety is a
and Utah in 1992. Surgery. 1999;126:66–75.
fundamental property of both. It might be argued 4. Kable AK, Gibberd RW, Spigelman AD. Adverse
that improving safety in surgical systems does not events in surgical patients in Australia. Int J Qual
require an entire restructuring of organizations and Health Care. 2002;14:269–76.
5. Dimick JB, Chen SL, Taheri PA, et al. Hospital costs
workflow; however, despite intense attention to this
associated with surgical complications: a report from the
subject over the past decade, incremental improve- private-sector National Surgical Quality Improvement
ment in safety has not been forthcoming with the Program. J Am Coll Surg. 2004;199:531–7.
existing models of care. Moreover, current systems 6. Khuri SF, Henderson WG, DePalma RG, et al.
Determinants of long-term survival after major sur-
have failed to address the patients’ overall needs.
gery and the adverse effect of postoperative complica-
Organizing surgical care around the pursuit of tions. Ann Surg. 2005;242:326–41.
safety as an overarching priority is a professional 7. Sanchez J, Barach P. High reliability organizations
obligation for all members of the health care and surgical microsystems: re-engineering surgical
care. Surg Clin North Am. 2012;92(1):1–14.
team. This goal can be accomplished by organiz-
doi:10.1016/j.suc.2011.12.005.
ing around and shaping a culture focused on reli- 8. World Alliance for Patient Safety. WHO guidelines
able performance but requires substantial for safe surgery. Geneva: World Health Organization;
investments in human capital. Readily accessible 2008.
9. Khan NA, Quan H, Bugar JM, et al. Association of
communication and information sharing are
postoperative complications with hospital costs and
essential components for creating high reliability. length of stay in a tertiary care center. J Gen Intern
A clinical microsystem concept involving surgi- Med. 2006;21:177–80.
cal personnel can be an effective vehicle for 10. Dimick JB, Pronovost PJ, Cowan Jr JA, et al.

Variation in postoperative complication rates after
achieving these goals.
high-risk surgery in the United States. Surgery.
It is impossible to establish a culture of safety 2003;134:534–40.
without leadership support and commitment. 11. Bratzler DW, Hunt DR. The surgical infection preven-
Leadership should protect and support “speak tion and surgical care improvement projects: national
initiatives to improve outcomes for patients having
up” attitudes where people stop the practice when
surgery. Clin Infect Dis. 2006;43:322–30.
they believe something wrong is going on. The 12. Mangram AJ, Horan TC, Pearson ML, et al. Guideline
leadership should adopt a nonpunitive approach for prevention of surgical site infection, 1999. Hospital
and provide the resources to improve the system. Infection Control Practices Advisory Committee.
Infect Control Hosp Epidemiol. 1999;20:250–78.
The challenge in getting the leadership on board
13. Prevention and treatment of surgical site infection.
is to involve them in the practice of safety and NICE guideline CG74. London (UK): National
provide them with evidence and data about qual- Institute for Health and Clinical Excellence, London,
ity and safety. Linking payment to patient safety UK, 28 October 2008 infection: prevention and treat-
ment of surgical site infection. www.nice.org.uk/
and clinical quality metrics will help draw leader-
CG74.
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Barach P. Hand-hygiene practices in the operating
Acknowledgement The authors would like to thank Dr. theatre: an observational study. Br J Anesth.
Paul Barach for his invaluable insights as well as his con- 2011;1–6. doi:10.1093/bja/aer162.
tributions to the chapter’s final edits. 15. Haley RW, Culver DH, White JW, et al. The efficacy
of infection surveillance and control programs in pre-
venting nosocomial infections in US hospitals. Am
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Surgical Safety in Developing
Countries: Middle East, North 52
Africa, and Gulf Countries
Abdulelah Alhawsawi and Paul Barach
“A known mistake is better than an unknown truth.”

—Arabic Proverb
tems to be able to treat the disorders of affluence.

ealth-Care Systems in MENA
H These countries have seen considerable
Region socioeconomic and health development in the
region over the past decades.
The World Health Organization (WHO) has cat- Group 2 consists mainly of middle‐income
egorized the countries of the Eastern countries which have developed extensive public
Mediterranean Region (EMR) into three groups health infrastructure but continue to face resource
based on population health outcomes, health sys- constraints. Group 2 countries include the follow-
tem performance, and level of health expendi- ing list: Egypt, Islamic Republic of Iran, Iraq,
ture. Group 1 comprises the Gulf Cooperation Jordan, Lebanon, Syria, Palestine, Libya, Tunisia,
Council (GCC) countries—namely, Bahrain, and Morocco. Group 3 consists of countries which
Kuwait, Oman, Qatar, Saudi Arabia, and the face constraints in improving population health
United Arab Emirates—will face an unparalleled outcomes as a result of lack of resources, political
and unprecedented rise in demand for health care instability, and other complex development chal-
over the course of the next two decades. It is esti- lenges. Group 3 countries include the following:
mated that total health-care spending in the Afghanistan, Pakistan, Yemen, Djibouti, Somalia,
region will reach US$60 billion in 2025, up from and Sudan [1].
US$12 billion today. No other region in the world Recently, many countries in the Eastern
faces such rapid growth in demand with the Mediterranean Region have recognized Quality
simultaneous need to realign its health-care sys- Improvement (QI) and Patient Safety as a priority
in their national health policy agendas. For exam-
ple, patient safety has been selected as a priority
A. Alhawsawi, MD, FRCSC, DABS (*)
Department of Surgery, Faculty of Medicine and by 14 out of 22 EMR countries for the opera-
Allied Sciences, King Abdulaziz University, tional planning 2016–2017.
Abdullah Sulayman Street, Jeddah 21589, Between 2006 to 2008, a region-wide patient
Saudi Arabia safety study was carried out in which a number of
hospitals from six EMR countries participated.
P. Barach, BSc, MD, MPH The aim of the study was to assess the magnitude
Foundation and Kyle John Rymiszewski Research and the scope of adverse events in Hospital set-
Scholar, Children’s Hospital of Michigan, Wayne tings in the region [2]. The objective of the study
State University School of Medicine, was not to compare countries or regions. Instead,
5057 Woodward Avenue, Suite 13001, Detroit, it was to obtain broad-based data on the magni-
MI 48202, USA
e-mail: [email protected] tude of patient harm, the most frequent harmful

860 A. Alhawsawi and P. Barach
incidents and their severity, when they had within hospital stays of 30 days. Length of stay is
occurred, what their causes were, and their shown as average for index admission in sample
preventability and contributing factors. record per hospital (Fig. 52.1).
The study showed that: on average, health In addition, the study also showed which proce-
care-related harmful incidents affected eight in dures and areas of activity are most likely to lead to
100 patients in the region. According to the study, adverse outcomes: For example, 34 % of the
four out of five incidents were preventable. This observed incidents resulted from therapeutic errors.
speaks to the considerable human and financial Other causes of adverse events were as follows:
costs that could have been averted. Added to diagnostic errors, surgical mistakes, obstetrics
these costs are the erosion of trust among patients causes, neonatal procedures, drug-related incidents,
and the unnecessary surcharge on the health-care fractures, anesthesia causes, and falls (Fig. 52.2).
system, which may lower the overall quality of In response to the health-care quality and
care (Table 52.1). patient safety challenges in the region, WHO—
The study also showed that rate of adverse EMRO (Eastern Mediterranean Regional Office)
events increased with increased length of stay. have suggested several improvement initiatives
Rates of adverse events went up from 4 to 25 % for the regional governments:
Table 52.1 Frequency of adverse events (AEs), % of preventable adverse events, and % of admissions associated with
adverse events that resulted in death in six EMR countries
AEs rate/100 admissions % admissions resulting in
Country (CI 95 %) % preventability (CI 95 %) death
Egypt 6.0 (4.7–7.3) 72.5 (62.8–82.2) 1.25
Jordan 2.5 (2.0–2.9) 83.3 (75.7–90.9) 0.61
Morocco 14.8 (12.6–17.0) 85.6 (79.9–91.3) 3.58
Sudan 8.2 (6.4–10.0) 55.1 (43.9–66.3) 0.75
Tunisia 8.3 (6.5–10.1) 85.7 (77.9–93.5) 1.29
Yemen 18.4 (16.5–20.3) 92.8 (89.9–95.7) 4.28
Total 8.2 83.0 1.85
Fig. 52.1 Rate of adverse events by length of stay, indicated as average for index admission in sampled records, per
hospital. Modified from Wilson RM et al. BMJ. 2012;344:BMJ.e832
52 Surgical Safety in Developing Countries: Middle East, North Africa, and Gulf Countries 861
Fig. 52.2 Type of error related to occurrence of adverse event shown as percentage of 890 adverse events with codes
for this classification. Modified from Wilson RM et al. BMJ. 2012
The clean care safer care initiative: The goal of health-care facilities are using the checklist is
Clean Care is Safer Care is to ensure that around 450 [4].
infection control is acknowledged universally Patient safety education: The World Health
as a solid and essential basis towards patient Organization (WHO) developed the Multi-
safety in the region. Such initiative also helps professional Patient Safety Curriculum Guide to
support the reduction of health care-associated accelerate the incorporation of patient safety teach-
infections (HAI) including the importance of ing into higher educational curricula. Many recent
hand hygiene and the consequences when pro- studies have highlighted that patient safety educa-
viders dont attend to prevention steps [3]. In tion needs to be more explicit and better integrated
EMR, the number of registered health care into health care curricula [5, 6]. Taking advantage
facilities through the “Clean Care Safer Care” of the global trends opening up for educational
website is only 1317 hospital (out of 9000 reforms, and the need to introduce patient safety
hospitals in EMRO). By comparison with the into health-care professionals’ curricula, the WHO
other WHO regions, almost every EMRO Multi-professional Patient Safety Curriculum
country has representation but efforts should Guide uses a health system-focused, team-
continue to increase the number of registered dependent approach, which impacts healthcare
health care facilities and improve commitment professionals and students learning in an integrated
to promote prevention and control of HAI. way how to operate within a culture of safety [7].
The safe surgery saves lives initiative: The goal of The patient safety-friendly hospital initiative
the “Safe Surgery Saves Lives Initiative” is to (PSFHI): The objective of the PSFHI is to
improve the safety of perioperative care around enhance patient safety by developing univer-
the world by ensuring adherence to proven stan- sal standards to which hospitals adhere to and
dards of care in all countries. The WHO Surgical by encouraging the participation of hospital
Safety Checklist has improved compliance with executives, clinicians and patients to collabo-
standards and decreased complications from rate in such effort. Furthermore, this initiative
surgery in eight pilot hospitals where it was encourages national health authorities and
evaluated. Only three countries from the EMR medical and nursing schools to participate in
out of 26 countries worldwide have mobilized the process of safe health-care delivery to
resources to implement the WHO Surgical complement national, regional, and global
Safety Checklist on a national scale. Globally health-care accreditation programs [8].
4132 hospitals were registered for the “safe sur- Recognizing the need to develop a valid and
gery saves lives” challenges; out of them 1790 reliable instrument for the assessment of patient
are actively using the checklist. The number of safety adapted to developing countries, WHO
EMRO embarked on a process of developing a Institutions (CBAHI) in Saudi Arabia, and

patient safety assessment manual. The develop- Health Care Accreditation Council (HCAC) in
ment of the assessment manual was followed Jordan. Tunisia has recently established a
by its implementation in representative hospi- national accreditation organization but is still
tals in seven countries (namely Egypt, Sudan, working on building the infrastructure (policies
Pakistan, Morocco, Jordan, Tunisia, and and procedures, quality standards, surveyors
Yemen) in mid-2009. See Fig. 52.3. This served training, etc.) to become operational.
two purposes—first, to assess the adequacy of International accreditation programs in EMR:
the patient safety program; and second, to pilot There are mainly three international accredita-
and further refine the PSFHI before rolling out tion bodies assessing the quality of EMR.
to other countries [9]. These are: (1) Joint Commission International
The safe birth checklist: Considering the impor- (JCI), (2) Accreditation Canada International
tance of both maternal and Child health, WHO (ACI), and (3) Australian Council on
has developed the Pilot Edition of the Safe Healthcare Standards (ACHS). The JCI is the
Childbirth Checklist, to support the delivery of most widely known international accredita-
essential maternal and perinatal care practices tion organization in the region, with the major-
[10]. The WHO Safe Childbirth Checklist con- ity of its activities taking place in group 1
tains 29 items addressing the major causes of EMR countries.
maternal death in low and middle-income coun-
tries. It is expected that many health care facili- Since the establishment of the Ministry of
ties will be using the Safe Birth Checklist during Health in 1950, the Saudi government has achieved
its pilot implementation in various settings, some important milestones in its journey towards
before the release of the clinical trial that is being reducing medical harm and improving patient
conducted in India to assess its impact [11]. safety situation in the Kingdom. In 1992, the Saudi
National accreditation programs in EMR: Commission for Healthcare Specialties (SCFHS)
Currently, Saudi Arabia and Jordan are the only was established as the body that regulates the licen-
two countries in EMR that have functioning sure of health-care professionals. In 2001, national
national accreditation organizations, namely: health accreditation started by the creation of
Central Board for Accreditation of Healthcare Makkah Region Quality Program (MRQP), which
Fig. 52.3 Achievement of critical standards across domains of patient safety. Modified from Siddiqi S et al. Int J Qual
Health Care. 2012;24:144–51
Fig. 52.4 Patient safety

milestones in Saudi Arabia
Fig. 52.5 Nation-wide sentinel events (2010–2014) based on the MOH reporting system, Saudi Arabia
later was expanded to include all the regions in the pidemiology of Harm in Saudi
E
Kingdom resulting in the creation of the Central Arabia
Board of Accreditation for Healthcare Institutions
(CBAHI) in 2005. In 2003, the Saudi FDA was Adverse events are not infrequent in the Saudi
established as the main regulator for Food, Drugs, health-care system, but the exact magnitude of
and Medical Equipment (Fig. 52.4). the problem have yet to be determined because
All the abovementioned activities have only a few studies in Saudi Arabia have addressed
shown the Saudi government’s commitment to medical errors. Currently, CBAHI is conducting
improving the patient safety situation in the a study with the WHO to assess the country’s
country, which culminated this year by announc- nationwide prevalence of adverse events. The
ing the establishment of the Saudi Patient Safety preliminary results of this study should be avail-
Center (SPSC). This center will play a pivotal able by December, 2016.
role in promoting patient safety by coordinating The ministry of health has a reporting system
with all stakeholders (Regulators, Providers, for sentinel events where hospitals, both ministry
and Public) to minimize preventable harm to of health (MOH) and private hospitals are required
patients. to report on a list of sentinel events within 48 h of
their occurrence (Fig. 52.5). Despite the problems bureaucratic and take a long time, resulting in
with underreporting, this program provides value providers losing their ability to attract clinical
by drafting corrective action plans and strategies staff from overseas. Second, the criteria for
to minimize harm and promote safety. The MOH licensure and renewal can be weak when com-
requires that each hospital that suffers a sentinel pared with international best practice, result-
event (SE) submits a Root Cause Analysis (RCA) ing in substandard professionals practicing
within a week from the incident (Fig. 52.6). medicine.
In the small GCC states, regulatory bodies
may also choose to guide the strategic capital
Quality Standards investments of providers regardless of owner-
ship. Because a critical threshold of patient vol-
Today, GCC and to a certain extent, MENA patients ume is required for specialty services in order to
make their private health-care decisions based on maintain quality, it is important that investment
word-of-mouth, advertising, and the physical in these specialties is carefully monitored to
external appearance of the institution. Quality stan- prevent excess supply relative to case volume
dards of providers are neither transparent nor (and, therefore, a decline in quality). A regulator
understood by patients, thus high-quality providers has the unique ability to manage capacity in
can struggle to distinguish themselves in the mar- these services by deciding whether to grant a
ket. Even worse, patient safety can be compro- provider a license [12]. Conversely, it can
mised by the lack of effective regulation of the encourage providers to offer services in areas
health-care sector. with the greatest unmet needs, such as the man-
Policymakers will have to undertake compre- agement of primary-care facilities and hospitals,
hensive regulatory reform in order to weed out low- long-term care, home healthcare, rehabilitation,
quality providers and protect patients. Currently, to and dialysis.
the extent that standards exist, they, for the most
part, apply to the private sector only and are not
applied to public health-care institutions. Moreover, Saudi Arabia Major Health Reform
the content of the standards and their enforcement,
tends to be weak and haphazard. The Saudi government has undertaken many ini-
In order to raise the quality level of the health- tiatives to improve the quality of the health-care
care sector and to allow competent private play- services in the Kingdom. One of the main quality
ers to thrive, policymakers must create regulatory improvement strategies the Saudi government
bodies that will define a set of comprehensive has introduced is accreditation.
operational quality and facility standards for all Health-care accreditation in Saudi Arabia
public and private providers. This body would be dates back two decades. In 1994, Saudi Aramco
responsible for licensing, inspecting, and enforc- established the Saudi Medical Services
ing these standards. Because this regulatory body Organization Standards. These standards
must equally apply and enforce standards to pub- worked as a quality assurance for health-care
lic and private health-care institutions, it should providers accepted by Aramco for its employ-
ideally be independent of the ministry of health. ees. Private and governmental hospitals had to
In addition, this regulatory body would also be meet Aramco standards to be accepted as a
responsible for the licensing and renewal of med- referral health-care institution for Aramco’s
ical professionals such as doctors, nurses, and employees.
allied staff. In 2001, Makkah Region Quality Program
Although processes do exist today in GCC (MRQP) was established. MRQP was a
countries for this function, they tend to suffer voluntary health-care accreditation program for
from two problems. First, they can be very health-care providers in the Makkah region.
This program involved written standards to be because of cultural reasons (e.g., excessive
met by governmental and private hospitals respect for superiors, fear of losing their job, etc.)
working in the Makkah region (57 hospitals). could compromise patient safety [14].
These standards were based on The Joint When it comes to perioperative patient safety,
Commission and ARAMCO standards. In the Saudi health-care system has introduced sev-
October 2005, the minister of health, in his eral structures and processes to try to guarantee
capacity as the chairman of the former Health safety but the outcome of these measures remain
Service Council (currently the Saudi Health variable depending on the setting. The Saudi
Council), established the Central Board for Commission for Healthcare Specialties (SCFHS)
Accreditation of Healthcare Institutions is the regulatory body for health-care p rofessionals
(CBAHI) in Saudi Arabia. International accred- and helps improve perioperative patient safety by
itation bodies have been participating in quality two main mechanisms: (1) Certification of
improvement activities in the Kingdom since Surgeons, Anesthesiologists, Nurses and Anesthesia
early 2000. Those include organizations like Technicians, and (2) Accreditation and oversight
the Joint Commission International (JCI), of residency and fellowship training programs in
Accreditation Canada, and The Australian surgery and anesthesia [12]. Despite these efforts,
Council on Healthcare Standards (ACHS). many patients continue to face potential periop-
Health-care accreditation, both national and erative harm for a variety of reasons. Some of
international, has definitely helped raise the these causes include:
awareness about the subject of quality improve-
ment amongst health-care professionals in the (a) Unqualified OR staff (surgeons, anesthesiol-
Kingdom. But despite variable and fragmented ogists, and/or nurses). This issue is a real
individual successes here and there, the nation- problem in smaller towns where many hospi-
wide overall impact of accreditation on patient tals are suffering from chronic shortages in
safety has yet to be determined. quantity and quality of human resources.
There’s a unique challenge that countries like (b) Lack of standardization: e.g., Surgical

Saudi Arabia and GCC face in providing health Safety Checklists, Time Out, Perioperative
care, the multiethnicity and multilingualism of Normothermia, VTE, and Antibiotic
health-care workers. Knowing the central role prophylaxis.
nurses play in the quality and safety of patient
care, it is very important that health-care work- The MOH has introduced a reporting system
ers, especially nurses, are both culturally and lin- for SE but it is still far from perfect and many
guistically competent to be able to address the adverse events go unreported (Fig. 52.6). To
patients’ daily needs. Nurses in the Kingdom understand the magnitude of the medical errors
come from several countries and speak different in the country, CBAHI, in partnership with the
languages [13]. The English language is the lan- WHO, will conduct the first nationwide study
guage used for communication amongst health- of its kind in the Kingdom to assess the preva-
care workers and knowing that English is not the lence and types of adverse events in a represen-
native language for the majority of the health- tative sample of hospitals. This will kick off in
care workforce poses an added communication early 2016 and should take around 1 year to fin-
challenge in the Saudi health-care facilities. ish. The results of this study will help support
Many nurses don’t speak Arabic very well, which the patient safety efforts in Saudi Arabia.
makes it more challenging for safe and effective Recently, the Saudi government under King
communication between nurses and their patients. Salman’s directives has announced a big strategic
Also, patient safety is very much dependent on initiative called Vision 2030. This represents
advocacy from health-care workers and having Saudi Arabia’s vision for the coming 15 years.
some nurses not speak up for their patients’ rights The Council of Economic and Development
Fig. 52.6 Root causes of the sentinel events between 2012 to 2015, MOH, Saudi Arabia
Affairs (CEDA) announced this strategic national world travel to the Kingdom to perform the hajj.
transformation plan to accelerate economic During the 2009 season, there were 2.3 million
growth and diversification in the Kingdom. pilgrims, 69.8 % of whom came from foreign
This initiative entails proposals by all govern- countries [15].
ment sectors. Each ministry has a component to Hosting such an event annually is a major
play in shaping the outlook of this major initia- logistical challenge that requires a planned and
tive. As a consequence, the Saudi health-care organized effort across numerous government
market will see major changes in areas like agencies and departments to ensure the fulfill-
health-care finance reform and a bigger role for ment of adequate essential services such as hous-
the private sector in service delivery. Time will ing, transport, safety and health care [16].
tell if such initiative will have a positive impact
on the Saudi health-care sector, specifically in the
area of quality and patient safety. Conclusions
In April, of 2016, the MOH announced the
establishment of the Saudi Patient Safety Center Health care demand and spending are rising
(SPSC). This SPSC’s vision is to eliminate sharply in the GCC and MENA countries. The
preventable harm in health-care facilities in the public is expecting more transparency, better
kingdom. The Center will focus on building the services, and more health care service
patient safety improvement capacity through accountability. Policymakers want the private
training, research, and collaboration with all sector to play a bigger role in their health-care
stakeholders including regulators, providers and systems, in both the provision and the financing
patients and their families. of care. The GCC/MENA governments must
make major regulatory and policy changes—
above all, using public funds to reimburse
Health Services nationals for the private health-care services they
During the Pilgrimage (Hajj) Season consume, and defining and enforcing a single set
of quality standards for both public and private
One of the main challenges that Saudi Arabia has providers. Recent increases in awareness of sur-
to deal with on an annual basis is the Hajj season gical morbidity in developing countries has
(Pilgrimage) as it embraces the two holiest cities placed greater emphasis on strategies to improve
of Islam, Mecca and Medina. Every year, between surgical safety in resource-limited settings. The
two and three million pilgrims from all over the implementation of surgical safety checklists in
GCC and MENA countries has specific barriers roundtable experience. Teac Learn Med. 2009;21(1):
52–8.
related to resources and culture. By establishing
7. World Health Organization. http://www.who.int/
strong regulatory bodies to define and firmly patientsafety/education/curriculum/en/.
enforce higher-quality standards for health-care 8. Siddiqi S, Elasady R, Khorshid I, Fortune T, Leotsakos
providers and medical professionals, policy- A, Letaief M, et al. Patient Safety Friendly Hospital
Initiative: from evidence to action in seven developing
makers will build the confidence of patients in
country hospitals. Int J Qual Health Care.
the surgical quality of health care, no matter who 2012;24(2):144–51.
provides it. 9. World Health Organization. http://www.emro.who.
int/entity/patient-safety/index.html.
10. Sarel D, Rodriguez B, Barach P. Childbirth hospital
selection process: are consumers really in charge?
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Future Directions of Surgical
Safety 53
Timothy D. Browder and Paul M. Maggio
“The most important question a modern professional can ask is not ‘What do I do?’ but
‘What am I part of?’”
—Donald Berwick, from Berwick D. Era 3 for Medicine
and Health Care. JAMA. 2016;315(13):1329–30
Product (GDP). As a share of GDP, it is expected

Introduction to rise from 17.4 % in 2013 to 19.6 % by 2024.
This rate of growth is unsustainable [7].
In 1999, the Institute of Medicine (IOM) report Surgical care is complex, driven by advances
To Err Is Human: Building a Safer Health in medical science and new technologies,
System concluded that 44,000–98,000 multidisciplinary care teams, and care that
Americans die each year as a result of prevent- must be coordinated through health care
able medical errors [1]. This was followed in systems. Not surprisingly, the majority of
2001 by the IOM report Crossing the Quality adverse events in surgical care are not related
Chasm [2]. Crossing the Quality Chasm focused to technical errors that occur in the operating
more broadly on the health care system and pro- room, but from errors that occur throughout
vided a practical framework for improving the the perioperative course [8, 9]. As a result,
delivery of care. In the report, six dimensions of quality improvement efforts in surgery have
quality care were defined as care that is safe, focused less on the surgeon and more on the
effective, patient-centered, timely, efficient, and health care delivery system [10]. Today organiza-
equitable. Although the IOM reports led to dra- tions such as The Joint Commission and the
matic policy recommendations, in the 15 years Agency for Healthcare Research and Quality
since their publication, there have been only (AHRQ) promote the use of systems tools and
limited improvements in patient safety, quality, methods to improve quality and safety and
and value. Patients continue to experience pre- national global initiatives such as the Surgical
ventable harm through errors that result in sig- Care Improvement Project (SCIP), the
nificant morbidity and mortality, while the Universal Protocol, and the WHO surgical
delivery of care remains costly and inefficient safety checklist focus on processes and coordi-
[3–5]. Medical errors have recently been identi- nation of care [11–14]. For surgeons this has
fied as the third leading cause of death in the led to greater emphasis on their nontechnical
USA [6], and health care spending continues to skills that facilitate performance within a com-
outpace growth in the US Gross Domestic plex system [15]. Nontechnical skills encom-
pass behaviors such as situational awareness,
decision-making, communication and team-
T.D. Browder, MD • P.M. Maggio, MD, MBA (*) work, and leadership [8]. Unfortunately, these
Department of Surgery, Stanford Hospital and skills have not been part of a traditional
Clinics, 300 Pasteur Drive, Stanford,
medical training, and it is failures in these
CA 94305-5106, USA
e-mail: [email protected]; areas that frequently contribute to adverse
[email protected] events. Donald Berwick, prior President and

870 T.D. Browder and P.M. Maggio
Chief Executive Officer of the Institute for were supported by the development of thresholds
Healthcare Improvement, stated it is more of acceptability by organizations such as The
important for care providers today not to ask Joint Commission on Accreditation of Hospitals
“What do I do?” but “What am I part of?” [16]. (now The Joint Commission) and Medicare [19,
Important advances have been made to improve 20]. This approach tends to be reactive, retro-
quality and safety in surgery, but the improvements spective, and frequently viewed as punitive. It
have been largely driven by incentives established was not until Avedis Donabedian and other care
by external organizations. They have been estab- providers championed a systems-based approach
lished by various payers, governmental organiza- to measuring quality that the science of health
tions, and consumer groups; not by surgeons. As a care improvement advanced dramatically. In a
result, the outcomes from these efforts have been 1966 article, Evaluating the Quality of Medical
limited. There has been a lack of significant physi- Care, Donabedian argued that quality should not
cian engagement and support, and physicians have be measured solely by the consequences of care
not invested in understanding and applying (Outcomes); quality must also take into consid-
improvement science to their practice [16]. Most eration who provides the care and where
physicians today do not know how to interpret a sta- (Structure), and how the care is provided
tistical process control chart (SPC) or perform rapid (Process) [21]. Although each component can be
tests of change using a plan-do-study-act (PDSA) measured individually, Donabedian emphasized
cycle [17]. For this to change, surgeons must learn that integration of all three components of the
to be effective leaders in providing collaborative triad are essential in assessing the delivery of
patient care; a surgeon’s nontechnical skills, such as care. Today, Donabedian’s Structure–Process–
communication and teamwork, will be as equally Outcome model continues to serve as the pre-
important as their technical skills. Only by embrac- vailing framework for assessing the quality of
ing systems-based improvement methods and sup- health care (Fig. 53.1).
porting a culture of safety will surgeons transform Which measures best assess surgical quality con-
and improve the delivery of surgical care [18]. tinues to be debated, but in general they can be cat-
egorized into one of Donabedian’s three domains.
Examples of structural measures include a hospital’s
Measuring Health Care Quality procedural volume and status of its ICUs. Better
patient outcomes have been reported for certain
During the second half of the twentieth century, complex procedures when performed at high-vol-
quality in American health care was largely ume centers, and organizations such as the Leapfrog
focused on quality assurance (QA). Outcomes Group have encouraged patients to seek care at cen-
such as morbidity and mortality were studied as ters with high procedural volumes and closed ICUs.
a means to monitor and eliminate errors, and Process measures are a focus of The Surgical Care
Fig. 53.1 The Donabedian

Quality Triad. Donabedian
theorized that the
integration of all three
elements of the triad
is essential in assessing
the delivery of care [21]
53 Future Directions of Surgical Safety 871
Fig. 53.2 Recommendations for when to focus on struc- quality of surgical care: structure, process, or outcomes? J
ture, process, or outcome metrics. Modified from Am Coll Surg. 2004;198(4):626–32
Birkmeyer JD, Dimick JB, Birkmeyer NJ. Measuring the
Improvement Project (SCIP). SCIP is a collabora- Although quality improvement efforts have
tion initiated in 2003 by the Centers for Medicare focused on perioperative care, there has been recent
and Medicaid Services (CMS) and the Centers for interest in assessing the surgeon’s performance in
Disease Control (CDC) to decrease surgical compli- the operating room. Historically this has been dif-
cations through adherence to certain perioperative ficult to measure, and surrogate measures such as
processes. Outcome measures are exemplified by procedural volume have been used as proxies.
the risk adjusted surgical outcomes provided by the Work by Birkmeyer et al. using intraoperative
ACS National Surgical Quality Improvement video have demonstrated that greater surgical skill
Program (NSQIP). NSQIP is the most widely rec- is associated with fewer postoperative complica-
ognized data collection, analysis, and reporting pro- tions and lower rates of reoperation, readmission,
gram for noncardiac surgery. Participating hospitals and visits to the emergency department [24, 25].
are provided surgical outcomes data that are How measures of surgical skill relate to measures
expressed relative to other hospitals as observed to of perioperative care and surgical outcomes requires
expected (O/E) ratios. An ACS NSQIP Surgical further study, but there is little doubt that surgical
Risk Calculator has also been developed as a clinical skill in addition to measures of the delivery system
decision support tool based on multi-institutional will influence future quality improvement efforts.
clinical data. By estimating the risks of most opera-
tions, surgeons and patients can participate in the
shared decision making process [22]. Health Care Systems Engineering
Each measurement domain with the Donabedian
framework has its strengths and weaknesses. Safety does not reside in a person, device or
department, but emerges from the interactions of
Recommendations for choosing the best measure components of a system
based on the procedure have been provided by (Institute of Medicine, 1999 To Err is Human:
Birkmeyer et al. [23] (Fig. 53.2). Building a Safer Health System) [1]
Systems engineering is a comprehensive approach entitled Better health Care and Lower Costs:
to analyze, design, and manage complex sys- Accelerating Improvement through Systems
tems. It incorporates a broad range of methods Engineering [4, 11]. The report to the President
and tools to integrate and coordinate personnel, called for systems-engineering know how to be
information, materials, and financial resources propagated throughout all levels of health care
[4, 26]. The origins of systems engineering delivery and recommended that the USA build a
date back to quality improvement initiatives at health care workforce equipped with systems
Bell Laboratories during the 1930s and 1940s engineering competencies to enable system rede-
and the work of Walter Shewhart and sign. Despite these efforts and data suggesting
W. Edwards Deming. Shewhart is regarded as that systems engineering techniques have been
the father of statistical process control and associated with significant improvements in
developed the first statistical process control health care quality and efficiency, these tools
(SPC) chart. W. Edwards Deming promoted remain underutilized. Their adoption has been
Shewhart’s work and was later known for the hindered by multiple barriers, including inade-
Deming Plan-Do- Study-Act (PDSA) Cycle. quate access to relevant data and analytics, health
During the post-World War II period systems professionals not trained to think analytically
engineering methodologies became widely about the delivery of health care, and industrial
adopted in industries outside of health care, and systems engineers without sufficient knowl-
where it has been used to successfully improve edge of the health care industry. Most significant
quality, efficiency, safety, and customer satis- is a fee-for-service payment system. A fee-for-
faction [27, 28]. Only recently have systems service system rewards the performance of pro-
engineering tools and models for quality cedures and not quality. It favors volume over
improvement been applied to health care. value and does not provide an incentive for effi-
Commonly used management models include cient or coordinated care [29].
Total Quality Improvement, Lean, and Six In recognition of the shortcomings of a fee-for-
Sigma. Where Lean identifies and eliminates service payment system, the Patient Protection and
waste (non-value added processes), Six Sigma Affordable Care Act, commonly known as the
identifies and eliminates sources of variability. Affordable Care Act (ACA) was passed in 2010.
Frequently used tools adopted from systems The ACA called for the creation of a pilot program
engineering include statistical process controls, to improve the coordination, quality, and efficiency
queuing theory, root cause analysis (RCA), of services by restructuring Medicare reimburse-
failure-mode effects analysis (FMEA), and ments from a fee-for- service model to bundled
human-factors engineering [4, 10] (Fig. 53.3). payments. Under a bundled-payment system hos-
The application of systems engineering tools pitals and providers will no longer be reimbursed
to improve health care has been advocated by for individual services (pay for volume). Instead, a
several organizations. In 2005, collaboration single payment is divided among hospitals and care
between the National Academy of Engineering providers for each episode of care (pay for value).
(NAE) and the Institute of Medicine promoted a An episode of care is based on a specific condition
framework for a systems approach in their land- and typically includes the initial inpatient stay plus
mark publication, Building a Better Delivery the post-acute care and all related services up to
System: A New Engineering/Health Care 90 days after hospital discharge. The Medicare
Partnership [26]. This was later followed in 2009 Bundled Payments for Care Improvement (BPCI)
by a report from the Agency for Healthcare pilot program began in 2013 [30], and it is antici-
Research and Quality (AHRQ) entitled Industrial pated that 50 % of Medicare payments will be tied
and Systems Engineering and Health Care: to alternative payment models by the end of 2018.
Critical Areas of Research, and in 2014 by a Alternative payment models include Accountable
report to the President of the USA from the Care Organizations (ACOs) or bundled payment
Council of Advisors on Science and Technology arrangements.
Fig. 53.3 Overview of systems engineering. Better PsCoAoSa. Better health care and lower costs: acceler-
health care and lower costs: accelerating improvement ating improvement through systems engineering.
through systems engineering. Modified from Technology Washington, DC; 2014
The implementation of new payment models organizations to maintain their financial viability.
that focus on episodic care is just beginning to In surgery, this has led to the development of
drive hospitals and providers to develop a more models for perioperative care such as Enhanced
coordinated care model. Increasingly, health care Recovery After Surgery (ERAS®) protocols and
organizations are incentivized to focus on value the Perioperative Surgical Home (PSH) [31–33].
by providing higher quality care at lower cost. ERAS is an evidence-based care protocol with
Health systems will need to deliver care more recommendations for patient care throughout the
efficiently and effectively through the evidence- perioperative care pathway. Approximately 20
based and standardized processes. Costly com- elements have been shown to influence outcomes
plications, such as length of stay and readmissions, such as length of stay, morbidity, and complication
will need to be avoided in order for health care rates. Key components include:
• Preadmission information and counseling that reinforce the focus on patient safety” [35].
• Nutrition: limited fasting, reduced use of Four key features of a safety culture provided by
nasogastric tubes, early oral nutrition the AHRQ Patient Safety Network include:
• Multimodal pain management: spinal or epi-
dural anesthesia/analgesia, NSAIDs, minimal • Acknowledgment of the high-risk nature of an
narcotic use organization’s activities and the determination
• Antibiotic and venous thromboembolism (VTE) to achieve consistently safe operations
prophylaxis • A blame-free environment where individuals
• Avoidance of salt and water overload, goal- are able to report errors or near misses without
directed therapy fear of reprimand or punishment
• Early removal of lines, drains, and urinary • Encouragement of collaboration across ranks
catheters and disciplines to seek solutions to patient
• Early mobilization safety problems
• Organizational commitment of resources to
The Perioperative Surgical Home represents a address safety concerns [36].
fully integrated perioperative care model. It applies
a patient-centered approach and promotes stan- Trust, reporting, and improvement are three
dardization, coordination, transition, and value of mutually reinforcing imperatives for achieving
care throughout the perioperative period (preoper- and maintaining a culture of safety [20]. Trust
ative, intraoperative, immediately postoperative, among staff can only be achieved within a
and post-hospital discharge) [34]. While the PSH blame-free environment where behaviors that
incorporates certain components of ERAS, it is a prohibit error reporting have been removed
broader concept that uses systems engineering [37]. Staff will then be empowered to report
methods and management strategies (Lean and Six risks, errors, and near misses in order to learn
Sigma) to optimize care [32]. Although the PSH and drive improvement. Ideally, within a cul-
remains in its operational nascence, there is little ture of safety early reporting identifies prob-
doubt there will be multiple future iterations of lems before serious harm has occurred.
this concept. At this time published outcomes are Unfortunately, this has not been the case in
sparse and data-based documenting and reporting health care. In health care unsafe conditions
of institutional experiences will be critical in shap- and adverse events are typically not reported
ing future efforts (Fig. 53.4). until after harm has occurred. A recent study
[38] identified five key challenges for why inci-
dent reporting in health care has not reached its
Culture of Safety full potential:
A culture of safety is an essential part of prevent- • Reports were inadequately processed. This is
ing or reducing errors and improving quality. As largely a result of inadequate resources to
defined by The Joint Commission, a culture of manage the volume of reports. As a result,
safety within health care represents “the sum- reports are inadequately triaged, analyzed, or
mary of knowledge, attitudes, behaviors and acted upon.
beliefs that staff share about the primary impor- • Lack of adequate medical engagement. The
tance of the well-being and care of the patients most successful improvements in patient safety
they serve, supported by systems and structures are accomplished with physician input. Without
Fig. 53.4 The perioperative surgical home. A fully integrated Modified from Desebbe O, Lanz T, Kain Z, Cannesson
perioperative care model that applies a patient- centered M. The perioperative surgical home: an innovative, patient-
approach and promotes standardization, coordination, transi- centred and cost-effective perioperative care model. Anaesth
tion, and value of care throughout the perioperative period. Crit Care Pain Med. 2016;35(1):59–66
physicians submitting adverse events, the OR clinicians and staff suggest that communica-
majority of events are reported by nursing staff. tion and teamwork in the OR are suboptimal [46].
• Insufficient visible action after an adverse This is based on perceptions of teamwork that
event was reported. Lack of feedback from the vary widely among members of the OR teams.
analysis to the reporters and relevant people in Surgeons believe their style of leadership is col-
the organization negatively influences front- laborative and respectful, and that teamwork in
line workers in reporting adverse events [39]. the operating room is good [47]. This is in con-
• Inadequate funding and institutional support. trast to other members of the OR team who
• Failure to capture evolving health informa- perceive the surgeon’s style of leadership as auto-
tion technology developments. Organizations cratic, and view the communication and team-
do not take full advantage of the electronic work in the OR less favorably [48, 49]. The largest
health record to support auditing and dissemi- discrepancy among members of the OR team was
nation of adverse event information. the establishment of a shared understanding of the
procedure. For complex operations, a shared
Although a great deal of attention has been understanding by all participating team members
focused on the technical aspects of incident is essential for optimal team performance, patient
reporting in health care such as data collection, safety, and outcomes [50].
online reporting systems, and analytic tools,
future efforts need to focus on engaging frontline
workers in the process. Physicians, in particular, Team Training
must feel safe reporting errors and should be
encouraged to be as proactive in reporting risks Based on evidence that better teamwork is associ-
and near misses as they are for sentinel events ated with fewer errors in the operating room, meth-
[40]. Reports must be handled in a transparent odologies such as Crew Resource Management
process and appropriate feedback provided to the (CRM) and Team Strategies and Tools to Enhance
reporters and relevant people within the organiza- Performance and Patient Safety (TeamSTEPPS)
tion [41]. Additional strategies to improve the cul- have been adopted to facilitate team communica-
ture of safety outside of the operating room tion and teamwork [51]. Originally developed in
include executive walk rounds and unit-based the aviation industry, CRM focuses on interper-
safety teams. During executive walk rounds senior sonal communication, leadership, and decision-
leaders can informally discuss safety issues and making [52]. TeamSTEPPS was formed in 2006
demonstrate the organization’s commitment to from the collaborative efforts of AHRQ and the
building a culture of safety. Unit-based safety Department of Defense and provides an evidence-
teams frontline staff, physicians, managers, and based framework to optimize team performance
senior leaders affiliated with one unit to provide that is specifically designed for health care pro-
sustained engagement and consistent follow fessionals. It is based on five principles: team
through in driving quality and safety [42, 43]. structure, communication, leadership, situation
Operating rooms are complex systems, and monitoring, and mutual support [53]. Improved
communication and teamwork are essential to operating room efficiency and diminished patient
establish and maintain a reliable culture of safety safety events have recently been shown to be asso-
[44]. Patients are cared for by multiple providers ciated with implementation of the TeamSTEPPS
in different locations, the procedures are invasive program [54].
and often technologically complex, and the
patients are sedated or anesthetized so they cannot
participate in the procedure. As a result, nearly Checklists and Team Briefings
50 % of hospital errors occur in the OR, and fail-
ures in communication represent the most com- Two tools used to sustain a culture of safety are
mon cause for these errors [45]. Recent studies of checklists and team briefings. In 2009, the World
Health Organization (WHO) published the Surgical Together, these principles produce a collective
Safety Checklist. Adapted from the aviation indus- state of mindfulness. To be mindful is to have an
try, use of the Surgical Safety Checklist has been enhanced alertness and awareness to details so
associated with decreased morbidity and mortality errors can be discovered and corrected before
[13, 14]. How checklists improve outcomes is less they escalate into a crisis [42]. The first three
clear, but evidence suggests that in addition to principles maintain high levels of safety through
ensuring that critical tasks are addressed they also anticipation, while the last two principles
improve communication and teamwork [39]. address containment once an unexpected event
Checklists are frequently used to encourage and has occurred [44].
direct preoperative briefings. Briefings involve the High reliability science has not yet been
entire operating team and promote a shared under- widely adopted in health care, and future studies
standing of the procedure. The use of briefings has will be required to understand the best frame-
been associated with decreased mortality in a work for its successful adoption. In the interim,
recent Veteran Affairs study [55]. a model proposed by Chassin and Loeb [58] for
the Joint Commission involves a series of incre-
mental changes in three essential areas: leader-
High Reliability Organizations ship, safety culture, and process improvement.
In order to progress towards a high reliability
High reliability organizations (HROs) are health care organization, leadership must be
industries that operate under hazardous condi- committed and support the ultimate goal of zero
tions and are exceptionally consistent in accom- patient harm, a culture of safety must be main-
plishing their goals and avoiding potentially tained throughout the organization, and robust
catastrophic errors [56]. Recent studies of HROs process improvement tools such as lean, six
such as the nuclear power industry, the Federal sigma, and change management must be widely
Aviation Administration’s Air Traffic Control adopted.
system, and aircraft carriers have provided
insight into how industries outside of health
care have been able to achieve and sustain high Resilience Engineering
levels of safety. High reliability science has
only recently been applied to health care, but it Resilience is the ability of a system to adjust its
offers the prospect that similar levels of quality operations before, during, or following a distur-
and safety, comparable to other HROs, can be bance; a resilient system is able to sustain safe
achieved. Work by Weick and Sutcliffe [57] and efficient operations in both expected and
identified five attributes of HROs: unexpected conditions. As described by
Hollnagel [59], a resilient system is characterized
• Preoccupations with failure. Regarding minor by four qualities:
errors or near misses as a symptom that some-
thing is wrong. • Ability to monitor conditions and performance
• Sensitivity to operations. Paying attention to • Ability to respond to both expected and unex-
what is happening on the front lines. pected condition in an effective and flexible
• Reluctance to simplify interpretations. Avoid manner
overly simple explanations and encourage diver- • Ability to anticipate future events and
sity in experience, perspective, and opinion. conditions
• Commitment to resilience. Training and prep- • Ability to learn from failures and successes
aration to respond when system failures occur.
• Deference to expertise. Decision making Resilience engineering (RE) is a relatively new
down to the people with the most expertise discipline to identify and value behaviors and
and related knowledge. resources that contribute to a system’s ability to
respond to the unexpected [60, 61]. Whereas and shape future quality and safety improvements
traditional approaches to safety focus on identi- in health care.
fying factors that contribute to adverse outcomes,
RE focuses on a systems ability to succeed in the
event of an adverse outcome [39]. In contrast to Conclusions
root cause analyses where the focus is on con-
tributors to what went wrong, in RE the focus is Health care in the USA is complex, and its out-
on contributors to what went well. comes are less dependent on the individual pro-
Resilience engineering is an important consid- vider and more dependent on the entire delivery
eration when carrying out performance improve- system. It has been over 10 years since the NAE
ment in health care. As we focus on improving and the IOM called for a systems approach to
efficiency and eliminating waste, we must take improve the delivery of health care, yet systems-
care not to undervalue and eliminate factors that based improvement strategies have not been
contribute to resilience. Resources that at first widely adopted. This is likely to change as CMS
appear to be unnecessary under normal operating begins to implement alternative payment strate-
circumstances may have value that is recognized gies such as bundled payments; there will be a
only during a crisis [60]. How to assess the latent greater incentive to provide coordinated, safe,
value of resources that contribute to resilience and efficient care. Surgeons are a natural fit to
under normal operating conditions has yet to be lead these efforts, but in order to do so they must
determined, but will certainly be a valuable con- embrace systems-based improvement strategies.
tribution to future efforts in quality and safety. Frameworks such as systems engineering have
been successfully applied in industries outside of
health care to improve quality and safety. In
Improvement Science health care, they offer the promise to transform
and improve the delivery of care.
Improvement science is a relatively new term that
has yet to be entirely defined. Influenced by the
Institute of Healthcare Improvement (IHI), for References
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Epilogue
“It always seems impossible until it’s done.”

—Nelson Mandela
Despite spectacular progress in the diagnosis and policy, and process improvement with the over-
treatment of surgical diseases over the past cen- arching goal of creating a vital resource for all
tury, real-world surgical care remains suboptimal individuals involved, directly or indirectly, in
and is characterized by considerable variation in providing surgical care. By outlining the cogni-
outcomes, persistent disparities, and too often, tive, social, technical, and operational elements
preventable defects causing harm to patients. The which contribute to variable outcomes, the
complexity, cultural, and system design issues of Editors hope that frontline practitioners, health-
contemporary healthcare delivery result in care care leaders, and all who design and manage sur-
that is often fragmented, unnecessarily costly, gical tools, implements, and workflow systems
and often not based on evidence. Additionally, it can re-engineer the surgical environment to opti-
is clear that patients are exposed to preventable mize outcomes, improve patient and workforce
harm as a result of poor coordination and com- satisfaction, and reduce costs. From concepts and
munication, inconsistent processes and practices, models of safety and reliability to practical chap-
and poorly designed systems. In addition, surgi- ters on preventing perioperative injuries, and a
cal team members—surgeons, anesthesiologists, focus on global challenges in surgical care, these
nurses, technicians, and other healthcare profes- pages provide a vast source of information for all
sionals—are increasingly disappointed with stakeholders in the surgical space to improve
healthcare reform and are uncertain about the quality and value in surgery. They introduce
future of their professions. In order to achieve organizational and cultural determinants of qual-
high reliability in surgical care, the existing para- ity and safety using a human factors lens and
digm must shift toward a systems-based and advance contemporary thought on managing
transparent approach that engages providers workforce wellness, designing more supportive
every step of the way and delivers reliable health- and nurturing culture, capturing and reporting
care services across the entire spectrum of care. adverse events, as well as considering the physi-
Moreover, credible clinical data must be used to cal design of surgical devices and facilities in
continuously measure and improve outcomes in a order to achieve consistent and optimal
manner that nurtures trust and cohesiveness outcomes.
among all stakeholders, not the least of which is Surgical care can be a model for healthcare
the patient and their caregivers. reform because of its many successes in fostering
This book brings together a wide array of cross-disciplinary and multidisciplinary collabo-
experts on quality, patient safety, systems, health ration. In fact, surgery pioneered the collection

J.A. Sanchez et al. (eds.), Surgical Patient Care, DOI 10.1007/978-3-319-44010-1
882 Epilogue
and sharing of risk-adjusted data over 100 years advocated. In Codman’s day, the suggestion was
ago when Ernest Codman, a forerunner in the particularly inflammatory since he proposed that
modern search for medical excellence, chal- outcomes rather than seniority should determine
lenged his surgical colleagues to share their out- whether surgeons should be promoted.3
comes with their colleagues and patients in 1916.1 Major changes are needed in the current model
Codman “walked the walk” as well as “talked the of surgical care delivery. In order to thrive,
talk.” He openly admitted his errors in public and healthcare institutions must focus on the quality
in print. In fact, he paid to publish reports so that of the care they provide, including cost-efficiency,
patients could judge for themselves the quality of through innovations that align the incentives of
his care. He sent copies of his annual reports to payers, patients, and providers. Engaging clinical
major hospitals throughout the country, challeng- staff in a forthright manner is critical to accom-
ing them to do the same. From 1911 to 1916, he plishing this realignment. With the changes in
described 337 patients who were discharged from medical care delivery and the focus on popula-
his hospital. He reported 123 errors. He measured tion health has come an uneasy and increased
the end results for all. Codman passionately pro- scrutiny and public oversight of surgical practice
moted transparency in order to raise standards. and outcomes. Should we pay huge amounts of
Codman said, “Let us remember that the object money for surgical procedures if they fail to
of having standards is to raise them.” However, improve quality of life? Improving the reliability
perhaps owing to his insistent nature, he often of care will require accepting this forced trans-
irritated his colleagues. One of them, Dr. Edward parency and embracing the opportunities inher-
Martin, wrote to Codman in 1914: ent in these new models of care. In 2016, the
“Dear Codman: thirst of the public for transparency, coupled with
God bless you! I suppose I should hate you if I payers and regulators seeking safer and higher
lived in the same town, but my feeling, being value care, has led the UK, the USA, Australia,
remote, is quite other. Indeed the very enemies Norway, and the Netherlands, for example, to
who lurk in second story windows with muffled broadly expand programs of public reporting of
rifles are waiting your passing, are the ones who surgical data about outcomes. The release of such
take off their hats in deepest respect as your cold, data is only the beginning of a major interna-
but beautiful, corpse is carried away.”2 tional revolution in public policy to make out-
Codman was obsessed with quality and comes data on patients and populations as well as
believed it was at the heart of surgical profession- cost publically available.
alism. “The idea was simple, “The common At the heart of a sustainable, generative, and
sense notion that every hospital should follow continuously improving organizational culture of
every patient it treats, long enough to determine healthcare is a system with three interlinked aims
whether or not the treatment has been successful, centered around trust and transparency that can
and then to inquire, ‘If not, why not?’ with a view lead to4:
to preventing similar failures in the future” (ital-
ics from Codman). While today not a very con-
troversial position, it is obvious few hospitals or
medical practices follow their patients as he
3
Brand R Ernest Amory Codman, MD, 1869–1940. Clin
1
Codman EA. A Study in Hospital Efficiency. Reprinted Orthop Relat Res. 2009 Nov; 467(11): 2763–2765.
by the Joint Commission on Accreditation of Healthcare Published online 2009 Aug 19. doi: 10.1007/s11999-009-
Organizations Press, 1 Renaissance Blvd, Oakbrook 1047-8, PMCID: PMC2758958
Terrace, Illinois 60181, 1996 4
West E. Organisational sources of safety and danger:
2
Mallon B. Ernest Amory Codman: The End Result of a sociological contributions to the study of adverse events.
Life in Medicine. Philadelphia, PA: WB Saunders; 2000. Qual Health Care. 2000;9(2):120–6.
Epilogue 883
• better outcomes (e.g., for individuals and safe practices.5 Avoiding difficult conversations
populations), keeps us from becoming more reliable. Without
• better performance of the system (e.g., higher trust, clinicians tend to resist intentional change,
quality, safety, value), and partly because competing commitments and
• better professional development (e.g., improved assumptions effectively keep the “status quo” in
work-related competence, joy, and pride). place. Moreover, the inability to implement
change can be exacerbated by patterns of behav-
How does the present punitive and secretive ior that incorporate “normalized deviance,” in
culture and style of management of hospitals and which some processes of care have evolved over
other healthcare environments which provide time to fit established work flow and systems
surgical care support these three interlinked even when these practices are “unsafe” and not
aims? Organizations and communities, including permitted.6 A culture of fear contributes to nor-
those in healthcare, respond to positive and affir- malized deviance and keeps clinicians from
mative thoughts and information: “Energy flows doing the right thing. The cognitive dissonance
where attention goes.” that clinicians and executives feel when con-
Real quality improvement requires bringing fronted by organizational opaqueness is predict-
together multiple systems of knowledge. If done able and can lead to a lack of sharing of
effectively, this combination could guide other information, lack of learning, and ultimately dis-
fields in healthcare down a bold path on “how to” ruptive behaviors, frustration, burnout, and high
think differently, be transparent, and emotionally “churn” rates.7
and intellectually engage all stakeholders. Additionally, important strategic decisions
Surgery can lead the way for the house of medi- must be made to accelerate the scale-up of surgi-
cine using the same innovative and forward- cal services in low-resource settings both in
looking leadership and passion that has made developed countries and in others. A robust
surgical care a modern marvel. accounting framework that disaggregates health
Mistrust in healthcare systems and providers expenditure by intervention, such as surgery, may
has contributed to cynicism and disengagement be necessary for systematic, safe, and efficient
by clinicians with rates as high as 45 % of provid- scale-up of surgical interventions. Increasing dia-
ers reporting symptoms of classical burnout and logue between surgical providers and political
depression. The growing pressures of an expen- leaders can increase the power of stakeholders to
sive and laborious system of medical liability can advocate for cost-effective and safe surgical care.
ultimately harm patients. This system focuses on Greater emphasis on the importance of surgical
blame and shame and drives defensive and some- care in achieving national health goals can
times perverse actions by providers and institu- strengthen internal and external framing of these
tions. Meaningful change through learning issues. Increasing and improved tracking and
happens at the level of discourse, through educa- public reporting of peer-reviewed, vetted surgical
tion, management, and training, and not through
courts of law. The best clues to changing the cul-
ture of healthcare come from listening to how 5
Edmonson A. 1999. Psychological safety and learning
clinicians and staff talk about their work, their behavior in work teams. Administrative Science Quarterly.
organizations, their colleagues, and their future. 1999;44(2):350–83.
Trust must be built around efforts to ensure 6 Vaughan D. 1999. The dark side of organizations: mis-
hierarchical and organizational transparency. take, misconduct, and disaster. Annu Rev Sociol.
1999;25:271–305.
When clinicians feel unsupported and threatened or 7
Amalberti R, Auroy Y, Berwick DM, Barach P. Five sys-
do not feel safe, they will not speak up about ongo- tem barriers to achieving ultrasafe health care. Ann Intern
ing and emerging consequences that undermine Med. 2005;142(9):756–64.
884 Epilogue
indicators could increase the priority given to perioperative care and coproducing with
surgery internationally. patients the best possible outcomes. In doing so,
This book is the product of a long-standing the contributing authors have provided a frame-
friendship and camaraderie fueled by a desire work as well as practical knowledge from a
by the Editors, seasoned clinicians, and health patient-centered, systems perspective which
services researchers, to bring together the most includes the view that patients and their families
current quality improvement science and inno- can also contribute to safe, reliable, and excep-
vative ideas with a specific focus on improving tional surgical outcomes.
Index
A requirements, 800, 801

Accountability sponsoring institutions (SI), 799
beliefs and values, 677 Accreditation organization (AO), 756
fiscal viability, 677 Achalasia, 136
just culture, 673 ACS NSQIP Surgical Risk Calculator, 871
OR, 673 Activity Based Costing (ABC) method, 792
RCA, 672 Acute kidney injury (AKI), 597
responsibility, decision-making, 672 Acute renal failure (ARF), 591
robotic surgery, 673 Acute respiratory distress syndrome (ARDS), 594
rule breaking and enforcement, 672, 673 Adaptive capacity, 30
Accountable Care Organizations (ACOs), 737, 824, 872 Administrative data, 20
Accreditation Advanced Alternative Payment Model, 824
actions, 775 Adverse cardiovascular events, 852
adaptation strategy, 770 Adverse events, 684, 699–700
benefits, 777, 778 deep-seated systems, 683
and certification, 776–777 healthcare system, 683, 689
clinical and organizational processes, 771 insurance claims, 687
cycle, 777 IRS (see Incident reporting systems (IRS))
factors, 775, 776 and ‘near misses’ activity, 686
health care organization, 777, 779–781 report safety-related events, 687
hypercomplexity of health care, 771, 772 Affordable Care Act (ACA), 822, 872
learning, experience, 773–776 Agency for Healthcare Research and Quality
proactive approach, 771 (AHRQ), 21, 81, 449, 480, 577,
quality and reliability, 771–773 788, 822, 869, 872
risk management, 772, 773 Aging, Demographics, and Memory Study
robust internal audits, 771 (ADAMS), 614
Accreditation Association for Ambulatory Health Care AHRQ report ‘Making Health Care Safer, 18
(AAAHC), 466 Air embolus
Accreditation Canada International (ACI), 862 AAE, 435, 436
Accreditation Council for Graduate Medical Education VAE, 435
(ACGME), 210 Alarm fatigue
ABMS general competencies, 800 alarm standards and codes, 269–270
accreditation, 799 federal agency reports, 263
AMA, 799 hospitals need, 264
culture of professionalism, 801 human factors and awareness, 266–267
duty hours, 801 influence and opportunities, 263
hospitals participating, resident education, 800 management, 270–271
institutional committees and councils, 800 medical device designers and manufacturers, 270
patient safety, 800 medical device features, 267–270
health care quality, CLER program, 799 monitoring devices, 264
practice improvement, 801 noise levels, 263
quality-assurance/performance improvement, 800, organizational environment, 271
801 principles, 271–273
quality for institutions, 802 source–path–receiver model, 268–269

J.A. Sanchez et al. (eds.), Surgical Patient Care, DOI 10.1007/978-3-319-44010-1
886 Index
Alertness management/fatigue mitigation, 801 NACOR, 727–729

Alternative payment models (APM), 824–825 NACOR vs. surgical registries, 729–731
Ambulatory surgery centers (ASC), 9, 461, 466, 768, 769 National Anesthesia Registry Projects, 733–734
ASCQR, 364 National Quality Forum, 731
CMS, 363 pay for performance, 723, 731
employee health, 370 performance measurement system, 732
environmental and patient safety, 368–369 perioperative care, 723
healthcare, 363 PRAN, 726
infection control and prevention, 369 The Regulatory Environment, 723–725
infections and communicable diseases, 370 self-inquiry, 723
leadership, 370 SNoMed, 731
monitoring infections, 370 universal patient identifier, 731
national organizations, 369 wake up safe, 726
outcome measures, 363, 364 Anesthesiology Performance Improvement and
QAPI, 364 Reporting Exchange (ASPIRE), 717
quality improvement program, 364 Anesthetists’ Non-Technical Skills (ANTS), 196
staff, 370 Anonymity vs. confidentiality, 689
tuberculosis (TB), 370 Antithrombotic prophylaxis, 355
American Board of Anesthesiology (ABA), 335 Appendectomy, 829
American College of Cardiology (ACC), 743 Aprotinin, 601
American College of Surgeons (ACS), 193, 206, 341, Arterial air embolus (AAE), 435, 436
414, 717 ASA Closed Claims Project, 725, 734
American College of Surgeons National Surgical Quality ASC Quality Collaboration (“ASC QC”), 363
Improvement Program (ACS-NSQIP), 450, ASC Quality Reporting program (“ASCQR”), 364
590, 717, 737–739, 745 Asia-Pacific Trauma Quality Improvement Network
American Congress of Obstetricians and Gynecologists (APTQIN), 842
(ACOG), 731 Assembling Reconfigurable Endoluminal Surgical
American Medical Association (AMA), 799, 821 system (ARES), 135
American Recovery and Reinvestment Act of 2009 Association for Professionals in Infection Control and
(ARRA), 89 Epidemiology (APIC), 438, 468
American Society of Anesthesiologists (ASA), 330, 434, Association for Perioperative Practice (AfPP), 341
724 Association of perioperative registered nurses (AORN),
American Society for Gastrointestinal Endoscopy 341, 369, 414, 577, 581
(ASGE), 469 Association of Program Directors in Surgery
American Society of Health-System Pharmacists (APDS), 193
(ASHP), 468 Australian Council on Healthcare Standards
American Society for Testing and Materials (ASTM), (ACHS), 862
465 Australian Incident Monitoring System, 464
Anesthesia Crisis Resource Management, 338 Automated sponge counting technology, 139
Anesthesia Incident Reporting System (AIRS), 335, 726 Aviation near-miss reporting systems, 690
Anesthesia Information Management Systems Aviation Safety Reporting System (ASRS), 690
(AIMS), 331–332, 727 Awareness, 40, 41, 45, 48
Anesthesia Patient Safety Foundation’s (APSF), 341, 414
Anesthesia Quality Institute (AQI), 335, 726
Anesthesia registries, 731 B
cancer surgery, 732 Baby Boomers, 817
clinical data warehouses and large group practices, Bacteriuria, 450
732–733 Baldrige Model, 772
Closed Claims Project, 725, 726 Bariatric surgery, 580
collaborative design and implementation, 731 Bayesian analysis, 316
data-rich medical discipline, 725 Big data, 725
emerging trends, 726 Bispectral Index (BIS), 353
harmonization, 731 Blanket and Solution Warming Cabinets, 534–535
health care experience, 731 Block time allocation and utilization, 318–319
information age and technology, 723, 725 Body mass index (BMI), 593, 666
macro political forces, 731 Brachial plexus nerve, 497, 499
microprocessors, 725 British conduct National Anesthesia Practice Survey
mobility, 731 (NAPS), 734
The MPOG Registry, 727 Bundled payment initiative for care improvement
myocardial infarction, 731 (BPCI), 787
Index 887
Burnout and distress Catheter-associated urinary tract infection (CAUTI)

absenteeism, 206 CDC, 450
ACGME, 210 gram-negative bacteria, 450
ACS committee, 206 HAIs, 450
anxiety, 208, 209 prevention, 451–452
articles and publications, 206 risk factors, 450
career stages, 207 urosepsis/systemic bacteremia, 450
competencies, 210 Catheter-related bloodstream infection (CRBSI)
delayed gratification, 207 chlorhexidine skin preparations, 452
depression and depersonalization, 208, 209 CLABSI, 452
healthcare professionals, 207 HAIs, 452
hierarchical stress, 207 multidrug-resistant organisms, 452
longitudinal data, 208 prevention, 453
MSWBI, 208, 209 risk factors, 452
progressive emotional exhaustion, 209 short-term and long-term catheters, 453
QOL, 206 systemic antibiotics and catheter removal, 452
responsiveness, self-interest, 210 vancomycin, 452
teaching wellness skills, 207 Centers for Disease Control (CDC), 341, 369, 418, 420,
Business associates, 77–80 438, 449, 515, 871
Business case, 305–306 Centers for Medicare and Medicaid Services (CMS),
105, 297, 335, 363, 413, 449, 493, 787, 817,
828, 871
C Central Board for Accreditation of Healthcare
Capital strategic planning committee, 669 Institutions (CBAHI), 862, 863, 865
“Caprini” grading system, 851 Central line-associated bloodstream infections
Cardiac Surgery Reporting System (CSRS), 821 (CLABSI), 452
Cardio-pulmonary arrests (CPA), 644 Central venous catheter (CVC), 452
Cardiopulmonary exercise testing (CPET), 592 Central venous pressure (CVP), 435
Cardiopulmonary resuscitation (CPR), 581 CERP. See Clinical enterprise resource planning (CERP)
Cardiovascular system, 595–596 Chain of survival
Care transitions, 624–626 failure to record, 639–640
and clinical communication, 623 failure to repeat, 644
definition, 623 failure to report, 641
discharge transition, 629–631 failure to system design, 644
medical errors, 623, 624 failure to treat, 641
operating room principles, reliable and safe care, 638–639
sign in/time-out/sign out, 625–626 recognize pathophysiological changes, 640–641
surgical scheduling processes, 624, 625 Charlson comorbidity index, 619, 621
postoperative transitions (see Postoperative Check list, CQI, 124–125
transitions) Checkpoint blockade therapy, 140
root cause, sentinel events, 623 Chief Medical Officer (CMO), 667
surgical care, 624 Chief Surgical Quality Officer (CSQO), 226, 227
Caregiver burden, 620–621 Child-Turcotte-Pugh classification, 596
Case duration predictions Chlorhexidine gluconate (CHG), 420
Bayesian analysis, 316 Cholecystectomy, 636, 829
computerized scheduling system, 316 CIS. See Clinical information system (CIS)
continuous communication, OR staff, 316 Clinical care information systems (CCIS), 257, 258
frustrating task, 315 APIs and HL7 messaging, 257
high volume cases, 317 best-of-breed solutions, 256, 258 (see also Clinical
improper scheduling, 317 services information systems (CSIS))
improving surgeon time, 317 data modeling function, 256
non-bell shaped distributions, 316 data warehouse, 256, 258
procedure-surgeon specific method, 317 ECIS, 258
scheduled hip procedures, 316 EMR vortex, 256
scheduled Whipple procedures, 316 engineering architecture, 257
time estimate, 317 implementation, 258
Catastrophic deterioration, 644 model, 258
Catherine’s blame-based mental model, 677 properties
Catheter draining system, 450 automatic version control, 258
Catheter related bloodstream surgical infections multisystem design, software platform, 257
(CLABSI), 600 painless expansion and incremental design, 257
888 Index
Clinical care information systems (CCIS) (cont.) goals, 636

radically reduced maintenance, 258 modified early warning score, 641
rapid prototyping, 258 peri-operative care continuum, 637
universal attribute coding, 258 RRT, 636, 637
universal data storage, 258 service delivery process, 637
user-controlled design, 258 stages of growth, 639
software architecture, 256 Clinical services information systems (CSIS)
superior approach, 258 data warehouse, 258
Clinical communication, 623 hospital setting, 256
Clinical decision-making, 403, 404 Clonidine, 595
Clinical enterprise resource planning (CERP) Closed Claims Analysis Project (CCAP), 333, 335
limitation, 251 Clostridium difficile infection (CDI)
methodology, 251, 253 bacterial overgrowth and toxin production, 456
model, 251 diagnosis, 456
paradigm, 251 gastrointestinal illnesses, 456
Clinical information system (CIS), 248 prevention, 456–457
dataflow and workflow, 252 risk factors, 456
design processes, 252 Clostridium difficile-associated diarrhea (CDAD), 456
designs, 252 CMS Medicare database, 743
IA, 251–253 Code of federal regulations (CFR), 583
microsystem, 253 Cognition problems, 614–615
operational workflow, 252 Cognitive error taxonomy (CET), 559
physical screen layout and design, 252 Cognitive impairment, 614
real-time changeability, 252 Communication and optimal resolution (CandOR), 659
software technology, 252 Communication and resolution programs (CRPs
system native interoperability, 253 broadening consensus
Clinical Initiatives Nurse (CIN), 260 self-regulatory and professional bodies, 657–658
Clinical learning environment (CLE) state laws, 658–659
accreditation process, 802 commitments, organizations, 651
ACGME standards, 802 developments
challenges and barriers, surgeons, 804–805 AHRQ demonstration projects, 659
CLER evaluation, 805, 806 CandOR toolkit, 659
core programs, 806 collaborative, accountability and improvement,
description, 802 659–660
fatigue management, mitigation and fitness, 811 error disclosure, 656
GME community, 805 event review, 652
group learners, 807 individual professionals, 660–661
health care disparities, 805 initial communication, 652
health care environment, 803–804 initial response to patient, 652
health care quality and quality improvement, legal and regulatory environment, 661–662
809–810 patient and family perspectives, 652
higher quality and reliability of care, 805 pioneers and early adopters
hospital/medical center, 806 COPIC insurance company, 657
hospital-based specialties, 806 UIMCC, 657
patient safety, 806–809 UMHS, 656
professionalism, 812 veterans health system, 656
QI, 807 public policy underpinnings, 650–651
self-improvement, 807 quality and safety improvement, 652
supervision, 810–811 resolution conversation, 652
surgical community, 803 Comorbid conditions, 619–620
surgical resident and fellow physicians, 807 Compartment syndrome, 501, 505, 507
teaching clinicians and clinical educators, 804 Complex systems, 699
teaching medical centers and hospitals, 805 Complexity science
training of residents and fellows, 803 attributing accidents, 27
transitions of care, 810 healthcare system, 26
young surgical learners, 804 human error, 26
Clinical Learning Environment Review Composite Performance Score (CPS), 824
(CLER), 243, 799, 802 Compounding Pharmacy Assessment Questionnaire
Clinical microsystems (CPAQ®), 468
approach, 637 Comprehensive Care for Joint Replacement (CJR), 787
Index 889
Comprehensive Critical Care, 638 research, 112

Comprehensive Unit Safety Program (CUSP), 298, 454 co-commissioning
Computer-assisted surgical (CAS) systems accurate treatment, 106
ADORA system, 389 CMS, 105
automatic assessment and recognition of surgical consumers’ checkbook, 105
phases, 389 environmental and educational factors, 104
cataract surgeries, 390 e-patient movement, 104, 105
high-quality images, 389 making decision, 104
human activities, in OR, 389 patient safety program, 105
intra-operative decision-making, 390 The Pew Internet and American Life Project, 104
OR processes, 389 physician-specific public databases, 105
time-consuming and expensive simulation sessions, registries, 105
390 co-delivery
transparency, 390 comprehensive surgical programs, 109
Congenital Heart Surgeons Society (CHSS), 219 degrees of prehabilitation, 108
Congressional legislation, 822–823 discharge planning, 109
Consolidated Framework for Implementation Research families, 109
(CFIR), 720 hospitalization, 110
Continuous process improvement (CPI), 252 patient-centered medical programs, 108
Continuous quality improvement (CQI) and patient people support, 109
safety Planetree model, 110
approaches, 122–124 rehabilitation center, 109
checklists, 124–125 wound care app, 110
concepts and activities, 121 community support, 102
Crimean War, 121 community-based model, 103
customer, 131 conceptual model, 102
evolution, 121 conditions, 102
industrial model, 122 designing
Ishikawa diagrams, 125 communication, 106
Kaizen approach, 121 cost, 108
“lean enterprise and production, 123 CRICO, 106
management philosophy and method, 121 decision-making tools, 107
manufacturing and health care, 122 informed consent, 107
PDSA cycle and the model, 123 medical records, 107
person’s evaluation, 131 Open Notes project, 107
perspectives, healthcare providers, 122 presurgical communication, 107
plan-do-study-act cycle, 122, 123 surgery, 107
process map/flowchart, 125 elements, 102
run and control charts, 127–131 facilities, 112
service excellence and high-value outcomes, 122 impact, 113
six sigma methodology, 123 management, chronic illness, 103
surgical adverse event root cause analysis, 129 minimum standard, 113
TQM, 121 patient activation, 101
Contract Pharmacy and Medication Management patient-centered care, 101
Consultation Services, 472–477 power dynamics, 101
Control chart, CQI, 128, 130, 131 principles of patient-centered care, 113
Controlled drugs, 466 productive team, 101
Co-production in healthcare, 104–112 public service project, 103
advisory councils, 113 quality and safety, 103
applications, 102 relationship, 101
clinical services, 102 role, 103
co-assessment service delivery process, 101
“communication and resolution” programs, 112 surgery, 103, 104
electronic tablets, 111 theories and methods, 103
HCAHPS, 110, 111 theory of, 101
patient perspectives, 112 Time Dollar theory, 102
patient’s treatment, 110 Cornell Elective Surgery Second Opinion Program, 407
patients report, 110 Coronary artery bypass operation (CABG), 575, 576
quality concerns and patient satisfaction, 111 Cost, 791–792
890 Index
Costs vs. benefits, IRS, 691 Diagnoses-related group (DRG), 792

Council of Economic and Development Affairs (CEDA), Diagnostic error
865–866 addressing system-related errors, 407–408
Covered entity, 77–79 aortic dissection, 398
Crew resource management (CRM), 60, 193, 234, 876 cancer-related surgery, 398
Crisis resource management (CRM), 338 “captain of the ship” approach, 406
Critical access hospital (CAH), 828 clinical microsystem, 406
acute MI and congestive heart failure, 831 cognitive- and system-related factors, 401
classes of procedures, 831 cognitive challenges, 404
CMS, 828 current dual-process paradigm, 402
comorbidities, 831 decision-making, 398
criteria, 828 definitions, diagnostic error, 397
financial and human resources, 828 domain-specific knowledge, 405
HCAHPS scores, 832 incidence, 399–401
mortality rates, 831 interdisciplinary, 406
payment systems, 831 intuitive decision-making, 402
rates of complications, 831 IOM report, 397
rural hospitals, 828 leadership style, 406
social and financial problems, 831 level of confidence, 403
surgical admissions, 831 Munchausen’s syndrome, 401
A Critical Analysis of Patient Safety Practices, 18 nontechnical skills, 406
Critical care transition program (CCTP), 628 practice reflectively, 405
Critical incident reporting system (CIRS), 734 rational pathway, 402
Cultural determinants of safety. See Organizational reliability and assurance, surgical diagnosis, 408
determinants of safety spindle cell neoplasm, 398
Culture of safety, 232–235 structure-process-outcome model, 398
ASC leadership team, 364 surgery, 404
characteristics, 365 surgical environment, 397
communication, 365 surgical pathology and cytology, 404–408
conflict, 366 surgical team training, 406
leadership, 366 system-related errors, 403
organization, 365 task-oriented activities, 403
patient safety, 365 training, 403
QAPI, 366, 367 web-based decision, 407
quality assessment and performance improvement work in teams, 406
program, 365 Diagnostic related group (DRG), 818
risk management, 367 Diameter index safety system (DISS), 330
root cause analysis, 367 Diffusion of innovations, ORs, 373
transparent and discloses, 365 Disability adjusted life-years (DALYs), 844
Current Good Manufacturing Practices (cGMP), 468 Discharge transition
care coordination, 630
ERAS, 630
D perioperative surgical medical home, 630–631
da Vinci® Surgical System, 133, 580 postoperative strategies, 630
D-dimer assay, 487 process, 629
Decision making, 45, 679 (see also Learning) risks associated, postoperative, 629
Deep venous thrombosis (DVT), 479, 480, 599, 851, 852 Dissemination, 278, 284, 287, 288
Deliberate practice, 187 Diversification, 589
Deming Plan-Do-Study-Act (PDSA) Cycle, 872 Donabedian model, 837–838, 871
Department of Health and Human Services, 724, 822 Dreyfus model, 189
Departmental gross square feet (DGSF), 161 Drug Enforcement Administration (DEA), 466
Depersonalization Drug procurement
burnout, 207, 208, 210 compounding pharmacy selection, 468
culture of self-denial, 210 drug defect reporting, 469
lack of conscience, 209 drug recalls, 469
risk of non-empathic, 209 emergency preparedness, 470–471
stress, 208 high-volume/high-cost drugs, 467
Depression/seclusion, 619 injection practices, 468
Design thinking. See Human factor engineering medical record, 469
Deterioration of patients, 639 medication management, 471
Index 891
medication system, 467 Endocrine system, 597

pharmacy and medication safety committees, 470 Endoluminal surgery, 135–137
pharmacy consultant, 469–470 Endoluminal techniques, 192
shortages and recalls, 467 Endoscopic procedures, 833
VBP, 471 Endoscopic retrograde cholangiopancreatography
wholesale, 467 (ERCP), 578
Duke Clinical Research Institute (DCRI), 741 English National Health Service, 350
Duty Hours Task Force, 801 Enhanced recovery after surgery (ERAS), 349, 630, 785,
789, 873
access, 354
E antimicrobial prophylaxis and skin preparation, 353
Early recovery after surgery (ERAS), 602 carbohydrates, 353
Early warning scores, 640 economics, 357–358
Eastern Cooperative Oncology Group (ECOG), 617 growing evidence, 350
Eastern Mediterranean Region (EMR), 859 hypothermia, 353
ECIS. See Emergent clinical information system (ECIS) implementation programs, 350, 356–357
Electrical injuries interventions, 351
bipolar, 423 intraoperative care, 353–355
electrical devices, 426 meta-analysis, 350
electrosurgery, 423 multidisciplinary team approach, 350
energy sources and modalities, 423 multi-professional and multidisciplinary medical
fluids/gases, 427 society, 350
monopolar, 423 nasogastric tube and abdominal drains, 354
radiation, 427 perioperative fluid balance, 353
surgical energies and safety considerations, 423, preanesthetic medication and anesthetic management,
425–426 353
surgical smoke, 427 prehabilitation and exercise, 352
ultrasonic devices, 426, 427 preoperative information, education, and counseling,
video-assisted laparoscopic and endoscopic 352–353
procedures, 427 preoperative optimization, 351–352
Electrocardiogram (ECG), 426 research outcomes and quality of life, 358
Electronic health records (EHR), 331, 450, 469, 578, 810 smoking and alcohol cessation, 352
Electrosurgical and electrocautery technology urinary catheter, 354–355
Blanket and Solution Warming Cabinets, 534–535 Enterococcus, 450
clinical knowledge, 531 Enterprise resource planning (ERP), 250
direct current injury, 532 Enterprise risk management (ERM), 70–80, 574
electrodes, 532 AHRQ formats, 83
electrosurgery vs. electrocautery, 529–530 calculation of risk score, 70
endoscopes and laparoscopes, 532 culture
ESU, 530, 531 avoiding, culture of fear, 71–72
fluoroscopy, 535 communication and trust, 71
forced air hyperthermia blankets, 533 function, chief risk officer (CRO), 76
heat sources, 534 organizations and hospitals, 70
hyperthermia pads, 533 patient safety and quality, 70
MR imaging, 535 planning and performance management, 71
nerve monitoring units and electrosurgery, 531–532 prevention, 72–76
phacoemulsifiers, 534 programs, 71
pulse oximeters, 534 employee survey, 72
radiant warmers, 534 entities, 78
thermal injury, surgical fires, 532–533, 535–537 event underreporting, 84
Electrosurgical unit (ESU), 423, 530–531 Federally Listed Patient Safety Organizations, 84
Elements of performance (EOP), 461 framework, 68
Emergency checklists, 643 function, chief risk officer (CRO), 76
Emergency Department Information System (EDIS), 259 healthcare organizations, 68
Emergency surgery, 613 identification, 67, 68
Emergent clinical information system (ECIS) information technology
architecture, 257 business associates (BA), 79
Ockham’s Razor of Design, 258 common audit findings, 80
run-time library of code, 258 entities and business associates, 77–78
Employee assistance program (EAP), 585 fine, Academic Medical Center, 78–79
892 Index
Enterprise risk management (ERM) (cont.) health care professionals and organizations, 635
fine, data breach, 78 management, 635
HIPAA privacy and security rules, 77, 79 metrics, 644
opportunities and benefits, consumers, 78 organizational culture, 636
personal health information (PHI), 77 RRS, 637, 638
pilot audit program, 78 surgical clinical microsystem, 636–637
policies and procedures, 80 Federally Listed Patient Safety Organizations, 84
security risk assessment, 79 Fee for service (FFS), 792, 817
managers care, 75 Feedback. See Video feedback
measuring, 68–70 Firefly™ imaging technology, 133
organization, 67 Fishbone diagrams, 125, 129
patient safety confidentiality, 82–83 Flawed systems, 670–671, 677
patient safety evaluation system, 83–84 Flexible, adaptive, coherent, energized, and stable
population, 77 (FACES), 213
preventable errors, 84 Frailty
principles, 68 compensation mechanisms, 614
PSES, 83 criteria, 614
rating scales for calculating risk scores, 70 disability, 614
report types, NPSD, 83 intermediate risk, 614
risk manager functions, 80–81 mortality, 614
sample risk domains, 69 phenotype, 614
senior leadership scores, 76 prehabilitation programs, 614
value to providers, 83 principles, 614
Entrustable professional activity (EPA), 197, 811 quality care, patients, 614
ERP. See Enterprise resource planning (ERP) severity, 614
Error analysis Frugal innovation, 840–841
anesthesia, 560 Functional Assessment of Chronic Illness Therapy
aviation, 558, 559 (FACIT), 95
high-risk fields, 558 Functional magnetic resonance imaging (fMRI), 195
mining industry, 559, 560 Fundamental Use of Surgical Energy™ (FUSE),
Errors in surgery 423, 531
malpractice claims studies, 560–561 Future of robotic surgery, 134, 135
observational studies, 561, 562
European Association of Congenital Heart Surgeons
(EACHS), 219 G
European Network for Patient Safety (EUNetPaS), 20 Gas delivery, 330
European Union (EU), 20 GCC. See Gulf Cooperation Council (GCC)
Evidence-based decision making Geriatric depression scale (GDS), 619
CSRS, 821 Geriatric syndromes
“fast track” cardiac surgery, 819 cognition problem, 614–615
NNE, 820 comorbid conditions, 619–620
STS, 821 decreased mobility/falls, 616
VCSQI, 820, 821 depression/seclusion, 619
Evidence-based health innovations and practices (EBPs), frailty, 614
277 function and disability, daily living activities, 617
Exploration, preparation, implementation sustainment life/care goals, 618–619
(EPIS), 279 nutrition problems, 616–617
polypharmacy, 615–616
Gestalt theory of psychology, 189
F Global burden of disease (GBD), 590, 591, 844
Failure mode and effects analysis (FMEA), 68, 329, 367, Global burden of surgery (GBS), 590
574, 687, 708–709, 872 Global implementation initiative (GII), 287, 288
Failure modes, effects, and criticality analysis (FMECA), Global medication trigger tool, 687
626 Global Operative Assessment of Laparoscopic Skills
Failure to arrest complications (FTAC), 601 (GOALS), 556
Failure to rescue (FTR), 600 Global patient safety alliance, 19
cancer, 644 Global Rating Index for Technical Skills
catastrophic deterioration, 644 (GRITS), 557
climate of care, 636 Global surgery
definition, 635–636 direct and indirect costs, 838
epidemiology, 636 HICs, 838
Index 893
Lancet commission, 838 Health Care Quality Indicator Project, 19

surgical and intensive care, 838 Health care reform, 88, 90
Goal directed therapy (GDT), 597, 603 Health care safety
Governing Board, 365, 366 culture control and development, 153–154
Graduate medical education (GME), 799 hospital nursing units, 147
health care disparities, 813 HROs, 147, 148
learning environment and organization, 813 implications, 154–155
Gross domestic product (GDP), 823, 869 medication errors and patient falls, 147
Guidelines for community noise, 264 organizational culture, 152
Gulf Cooperation Council (GCC), 859 organizational determinants and safe outcomes,
Gunderson Lutheran system, 830 150–151
properties, 147
safety climate, 152
H safety culture and outcomes, 152, 154
Hajj season (pilgrimage), health services, 866 safety management, 148–150
Handover, 627 Health care systems, 777
Handwashing, 179 ACA, 872
Harm ACOs, 872
anaesthesia, 17 AHRQ, 872
clinical processes, 15 comprehensive approach, 872
complexity, 16 coordinated care model, 873
epistemology, surgical safety, 16 FMEA, 872
healthcare, 15 payment models, 873
hypovolaemia, 18 PDSA cycle, 872
interventions, 15, 16 perioperative care model, 874
management processes, 15 PSH, 873
meta-analysis, 17 quality and efficiency, 872
nosocomial infection, 17 quality improvement initiatives, 872
perioperative areas, 18–20 RCA, 872
retrospective care record reviews, 17 SPC chart, 872
surgical safety, 16 total quality improvement, 872
team members, 16 Health Care Transformation Task Force, 787
HCAHPS. See Hospital consumer assessment of Health care-associated infections (HAI), 861
healthcare providers and systems (HCAHPS) Health information technology (HIT)
Health care CERP, 247, 261
administrative data analysis and electronic medical design and testing processes, 261
records, 845 ECIS model, 261
components, 837 features, levels, 255–256
financial situation, 838 immediate adaptability (IA), 249–250
infrastructure, 842 integrated architecture, usability, 248–249
LMICs, 842, 844 investment, 247
QI methodology, 842 levels hierarchy paradigm, 248
quality and safety, 838, 840, 844 ROI, 247
Health Care Accreditation Council (HCAC), 862 system adaptability, 249–250
Health Care Financing Administration (HCFA), 817 Health Information Technology for Economic
Health care microsystems, 637 and Clinical Health Act (HITECH), 78, 331
Health care professionals, 635 Health quality improvement programs, 850
Health care quality, 94–96 Health services, Hajj season (pilgrimage), 866
experiences Healthcare complexity, 4
CAHPS, 96 Healthcare Consumer Assessment of Hospitals and
HCAHPS, 96 Provider Survey (HCAHPS), 733
healthcare quality, 96 Healthcare failure mode and effect analysis (HFMEA),
patient feedback, 96 305, 437
patient ratings, 96 Healthcare safety network (NHSN), 449
patient reports, 96 Health-care systems in MENA region, 861–863
tools, 96 adverse events, EMR countries, 860
health decisions, 93 EMR countries, 859
PRO (see Patient-centered care (PRO)) GCC, 859
qualitative methods, 93 harmful incidents, 860
surgical care, 97 human and financial costs, 860
894 Index
Health-care systems in MENA region (cont.) HVC Curriculum, 88

improvement initiatives, regional governments innovations, 87
clean care safer care initiative, 861 measurements, 89
international accreditation programs, medical conditions, 90
EMR, 862, 863 organizations and national institutes, 88, 90
national accreditation programs, EMR, 862 patient perspectives, HVC, 90–93
patient safety education, 861 decision making, 91
PSFHI, 861 patient-centered care, 90
safe birth checklist, 862 values, 90
safe surgery saves lives initiative, 861 PRO data, 90
middle‐income countries, 859 public reporting, 89
patient safety challenges, 860 quality (see Health care quality)
preventability and contributing factors, 860 recommendations, 88
QI and patient safety, 859 reduction, healthcare cost, 88
rate of adverse events, 860 screening protocols, procedures and interventions, 88
Healthcare-associated infections (HAIs), 5 SPORT, 90
ACS-NSQIP, 457 support, 88
acute care hospitals/post-acute rehabilitation three-tier hierarchy, 89
centers, 449 value, 89
aggressive infection control, 457 HIT. See Health information technology (HIT)
CAUTI, 450–451 Hospital-acquired conditions (HAC), 449, 493
CRBSI, 452–453 Hospital-based reporting systems, 685–686
criterion, 450, 451 Hospital consumer assessment of healthcare providers
hospitalization costs, 450 and systems (HCAHPS), 110, 264, 300,
pneumonia, 454–455 831, 832
prevention, 455 Hospital engagement networks (HEN), 600
quality, 450 Hospital episode statistics, 21
SSI, 453–454 Hospital safety design
Healthcare-associated pneumonia (HCAP), 455 administrative services, 170, 171
Hepatic lobectomy, 649 alleviating pain and infection control, 159
Hepatocellular carcinoma, 649 anesthesia, 159
High reliability organizations (HROs), 227, 232–235, communications, OR, 167–168
603, 877 DGSF/OR, 161, 162
concept and characteristics, 32 gaming work session, 161, 163
constant communication, 33 Houston Methodist Hospital, 167
continuous learning, 33 ICU recovery position, 169
healthcare organisations, 33 lean design, 171–172
high-reliability organisation, 32 lean surgical suite planning, 164, 165
limitations, 33–34 new hybrid operating room, 159, 160
High-income countries (HICs), 838 new layouts and flow, 164–165
High-reliability organizations (HROs), 147, 148 old operating theatre, 159, 160
High-risk surgery (HRS) operating rooms, 166
complications, 590 OR desk, 167, 168
economics, 591–592 OR size, 166–167
NSQIP analysis, 590 patient needs, 170–171
risk and risk registries, 589–590 perioperative team, 171
risk examples, 591 phase 2 recovery, 169
risk scoring systems, 590 physician and staff support areas, 170
surgical and organ dysfunction risk planning for change, 168, 169
models, 590, 591 postanesthesia care unit, 168–169
High-value care and services, 90, 91, 93–97 preoperative areas, 165–166
ARRA, 89 program building blocks, 161, 162
components, 89 PSH intraoperative goals, 172, 173
cost-conscious care, 88 PSH postoperative goals, 172, 174
costs, 88, 89 PSH-proposed preoperative goals, 172
degenerative spondylolisthesis trial report, 90 public areas, 165
delivery system, 88 robust communication and documentation, 175
efforts, 90 square footage allocation, 161, 163
healthcare expenditures, 87 sterilized instruments, 159, 160
HRQL, 90 suite layout characteristics, 164, 165
Index 895
surgery reception and waiting lounge, 165 socio-technical environments

Surgical Staff Lounge, 170 behaviour steering, 375
surgical suite organization and design, 161–164 clean air compliance, 375
universal ORs, 168 diffusion of innovation, 373
working definitions, 172–173 high-risk areas, 373
Hospital value-based purchasing (HVBP), 825 interactions, 375
Host risk factors LAF systems, 374
age, 593 safety improvements, 375
anabolic agents, 592 skills, 375
anesthetic techniques, 592 teaching, training, and changing staff behaviour,
beta-blockade, 592 375
cardiovascular system, 595–596 socio-technical systems theory, 40
CHA2DS2-VASc score, 596 surgical care, 47
CPET, 592 technology acceptance model, 43
endocrine system, 597 time and visual demands, 39
hematologic and immune system, 598–599 touch-screen interfaces, 40
mass and BMI, 593 video feedback (see Video feedback)
metabolism and nutrition, 598 Human performance
neurologic system, 594 human needs, 178–180
pulmonary system, 594–595 interior architecture and design, 179
renal system, 597 lighting and performance, 178
risk management systems, 592 observing errors and system factors, 178
skin and wounds, 597–598 patient well-being and family satisfaction, 180
splanchnic system, 596–597 postoperative phase, 179–180
stress response, 592 pre-design, 180–181
thermoregulation, 592–593 safe surgical function, 180–181
Human error, 665, 667, 668, 673, 677, 679 workspace, surgical and anesthesia service,
Human factor engineering, (ORs), 373–376, 378, 379, 177–178
381–388 Hypothermia, 437–438
CAS (see Computer-assisted surgical (CAS) systems) Hysterectomy, 666
cognition, 44–46
design thinking, 392
device design, 42–44 I
diffusion and learning, 391 IA. See Immediate adaptability (IA)
“direct manipulation” concepts, 40 IA-CIS, generic architecture
DOS-based command-line interfaces, 40 advantage, 254
double-loop learning, 392 CERP methodology, 253
floor marking clinical care systems, 253
application of OR, 375 coherent method, 253
awareness, 379 design tools, 253
corneal transplant, 379 HIT ecology, 253
design intervention, 381 interoperability, 253, 255
equipment, ophthalmic operations, 375 support for work, 253
hospital sessions, 378 system native interoperability, 253
instrument table, 378 user community, 253
laminar flow system, 375 The Illinois Surgical Quality Improvement Collaborative
Mayo stands, 378 (ISQIC), 717
nurses, 381 Immediate adaptability (IA)
ophthalmic surgery, 379 best-of-breed HIT system, 250
position of the patient, 379 CERP, 250, 251
project, 378 CIS, 251–253
REH, 376 clinical requirements and analyses, 250
surgical lamp, 379 EMR systems, 250
ventilation rate, 375 HIT systems, 250
health care teamwork, 392 real-time design, 252
humans and automation, 40–42 training, 251
performance-shaping factors, 46–48 Immunotherapy, 140
safety and quality improvement, 391 Imperial College Surgical Assessment Device (ICSAD),
Safety and Quality Improvement, 391 194
scientific management principles, 39 Implantable cardioverter defibrillator (ICD), 426
896 Index
Implementation science, 279, 878 patient safety program, 684

definition, 278 reporting system, 684
developing field, 286 types, 684–685
education and training, 288 web-based information systems, 684
effective and efficient delivery, 277 Indocyanine green (ICG), 133
EPIS, 279 Infection control committee, 470
evaluation research implementation, 278 Infection Control Preventionist Nurse, 371
General Accounting Office, 278 Infection control process measures, 364
Global Implementation Initiative (GII), Information technology (IT), 727, 771
287, 288 Injury, skin and tissue injuries, 528, 529
implementation strategies, 287 In-patient Prospective Payment System (IPPS), 818
interdisciplinary, 286, 287 Input-mediator-output-input (IMOI) model, 55
open access movement, 277, 278 Input-process-output (IPO) approach, 55
outcomes, 279–281 Institute for Healthcare Improvement (IHI), 173, 297,
practitioners, 278 420, 638, 785, 790, 878
public health and healthcare settings, 277 Institute for Safe Medication Practices (ISMP), 471
and quality improvement, 287 Institute of Medicine (IOM), 226, 665, 788, 789, 869
research and evaluation efforts, 277 Integrated care pathways, 785
rethinking scientific rigor, 287 Integrated Management of Emergency and Essential
translate research, 278 Surgical Care, 840
Improving diagnosis in health care, 397 Integrated practice unit (IPU), 602
Inadvertent hypothermia, 413, 422, 437–438 Integrating reporting systems, 687
Incident investigation Interdisciplinary team, 60
adverse events, 699–700, 705 International Academy of Compounding Pharmacists
clinical micro-system, 695 (IACP), 468
clinical operations, 705 International accreditation programs, EMR, 862, 863
clinical practice and biomedical technology, 695 International Atomic Energy Agency (IAEA), 152
definition, purpose, 697–698 International Building Code (IBC), 177
develop effective strategies, 711–712 International DUQuE Consortium, 19
engaging staff, 706–707 International Organization for Terminology in Anesthesia
FMEA, 708–709 (IOTA), 731
framing, investigation process, 702 International practice challenges, surgery
hospitals and health service, 695 benchmarking and data reliability, 854
identifying contributing factors, 703–704 cultural barriers, 853
inquiry, 698–699 health tourism and travelling, 854
investigation phase, 709 lack of education, 853
investigation report, 704–706 language/communication barriers, 853
investigation team report, 706 patient and family involvement, 853–854
local experience and expertise, 695 status hierarchy barriers, 854
local knowledge, 700–701 Internet of things, 603
perioperative setting, 710–711 Interoperability, 248, 249
perioperative surgical safety programs, 695 Interpretive diagnostic error, 404–408
PRA, 707–708 Interviews, 111
problematic situation, 710 Intra-interoperability, 255
quality and safety departments, 695 Intraoperative phase. See Human performance
questions and gathering information, 702–703 Intraoperative tissue injury
risk assessment and triage, 702 accidental injury, 520
staff debriefings, 704–705 histologic examination of specimens, 522
surgical trauma case, 696–697 medical devices, 522
team meetings, 703 medical procedures, 520
translating knowledge, 709, 710 potential etiologies, 522
Incident reporting systems (IRS) Investigation, skin and tissue injuries
characteristics, 686 accidental skin injury, 525
costs vs. benefits, 691 clinical steps and recorded information, 523
definitions, 684–685 components, 524
harms prevent, 684 equipment inspection, 527
high-risk and safety-critical industries, 684 factors, 525
monitor and collect information, 687 process, 524
multicenter specialized systems, 685 questionnaire, 527
Index 897
questionnaire, 527–528 team training, 199

team, 524 technical skills, 194–195
Ishikawa diagram, pediatric cardiac surgery, 129 training, 186
ISO, 757 training, surgical team, 193
ISO 31000, 68 training/levels of expertise
associative stage, 188
autonomous stage, 189
J declarative and procedural knowledge, 192
Jackknife/Kraske’s position, 509 declarative stage, 188
Japanese Society of Anesthesiologists, 733 Kantian representation, 189
JCI. See Joint Commission International (JCI) professional functionality, 191
Joint Commission, 51, 264, 341 schema, 189
Joint Commission International (JCI), 862, 865 sensorimotor control, 190
Joint Commission, American Society Anesthesiologists, skill acquisition, 188
341 stages, 188
Joint Commission’s sentinel event guidelines, 677 tacit knowledge, 188
The Joint Commission’s Universal Protocol™, 414 task parameters, 191
Just culture, 673 Length of stay (LOS), 592
Licensed independent practitioners (LIPs), 579
Linking process measures, 487
K Liver dysfunction, 596
Karnofsky performance score (KPS), 617, 618 Low- and middle-income countries (LMICs)
Kelly’s mental model, 670 challenges, 838, 845
Kidney transplantation, 592 data collection, 844, 845
Knowledge, skills, and attitudes (KSAs), 56, 59 enhanced training, surgeons, 840
Knowledge-to-action (KTA), 793 frugal innovation, 840–841
health care facilities, 838
HIC surgeons practicing, 839
L operating theaters, 838
Laparoscopic cholecystectomy, 650 retrospective case note review, 845
Laparoscopic Heller myotomy, 137 surgeon density ranging, 839
Laparoscopic ventral hernia (LVH) simulator, 562 surgical disease, 838
Laryngeal mask airway (LMA), 462 surgical providers, 839
Leadership, 212, 219 surgical quality improvement, 841–842
Leadership and Organizational Change for surgical safety processes, 842–844
Implementation (LOCI), 282 unreliable electricity and water supplies, 839
“Lean” methodologies, 791 Low molecular weight heparin (LMWH), 355
Lean Six Sigma process, 171
Learning, 188–192
adult learning/andragogy, 185 M
adverse events, 679 The Maintenance of Certification in Anesthesiology
assessing expertise, 194 (MOCA®), 335
characteristics, 686 Makkah Region Quality Program (MRQP), 862, 864
characteristics, expertise and expert behavior, Malignant hyperthermia (MH), 471
186–188 Master surgical schedule, 315
commitment, 199 Maternal Quality Improvement Project (MQIP), 731
entrustable professional activities, 197–198 MBSR. See Mindfulness-based stress reduction (MBSR)
experiential learning model, 185 Measuring health care quality, 870–871
goals and effective communication, 199 Mecca, 866
medical education, 185 Mechanical ventilation, 455
microsystem, 188, 199 Mechanical vs. complex adaptive systems,
motor skill acquisition, 185 214–215
NTS, 195–197 Medical emergency team (MET), 637, 641, 643
organization, 715 Medical error, 400
patient safety, 685 honesty and transparency, 650
perioperative environment, 199 medical malpractice law, 654
population-based approach, 685 research, 656
professional training, 185 sharing information, 655
recruiting and training, surgical team, 192–193 surging malpractice insurance, 658
team member, 199 Medical executive committee (MEC), 365, 470
898 Index
Medical malpractice liability Model for end-stage liver disease (MELD), 596
adversarial system, 654 Modern surgery, 650
CRPs, 650 Modified Early Warning Score (MEWS), 643
effective communication and resolution of Morbidity and mortality (M&M) conference, 808
errors, 655 MSWBI. See Medical Student Well-Being Index
informed consent, 655 (MSWBI)
internet-based rating systems, 655 The Multicenter Perioperative Outcomes Group
legal and regulatory constraints, 654 (MPOG), 335, 727
modus operandi, 655 Multidisciplinary team (MDT), 852
physicians, 655 Multi-team systems (MTSs), 54
protecting and managing personal information, 655 Myocardial revascularization procedure, 853
reinforce physician professionalism, 654
standard of care, 654
transparency, 655 N
Medical Student Well-Being Index (MSWBI), 208 National Academy of Engineering (NAE), 872
Medicare Access and CHIP Reauthorization Act National Academy of Medicine, 51
(MACRA), 724, 823–824 National accreditation programs, EMR, 862
Medicare Fee Schedule (MFS), 818 National Anesthesia Clinical Outcomes Registry
Medicare Payment Advisory Commission (MedPAR), (NACOR), 335, 727–729, 732
823 National Cardiovascular Data Registry (NCDR), 743
Medicare’s Value-Based Purchasing program, 590 National Clinical Audits, 20
Medication errors, 414–416 National Comprehensive Cancer Network (NCCN), 95
Medication management, 471 National Death Index (NDI), 743
Medication safety management. See Safe medication National Fire Protection Association (“NFPA”), 368
management National Healthcare Safety Network (NHSN), 302, 364,
MENA. See Middle-East and North Africa (MENA) 370
Mental models National inpatient sample (NIS), 831
adverse event, 665 National Nosocomial Infections Surveillance (NNIS)
building blocks, 675 System, 449
Catherine’s blame-based, 677 National Patient Safety Agency (NPSA), 284
decision-making, 679 National Patient Safety Foundation, 264
Evelyn’s risk status and collaborative preplanning, National Patient Safety Goal (NPSG), 271, 331, 341
670 National Quality Forum (NQF), 170, 341, 363, 413, 731,
faulty systems, 674, 679 744
flawed systems, 671 National Reporting and Learning System (NRLS), 16
interviewing staff, 673 National Surgical Quality Improvement Program
Kelly’s knowledge, 669–670 (NSQIP), 572, 590, 805, 832, 871
learning, 679 Nation-wide sentinel events, 863
MISS, 670 Native interoperability, 252
pre-compiled response, 670 Natural Orifice Surgery Consortium for Assessment and
RCA teams, 675 Research (NOSCAR), 136
recognition-primed decision-making, 670 Natural orifice transluminal endoscopic surgery
resilience, coping, 676 (NOTES), 135–137
screening anesthesiologist, 669, 675 ‘Near misses’ activity, 683, 690–691
screening process, 670 advantages, 691
Merit-based incentive payment system (MIPS), 724, 824 analyses, 691
Methicillin-resistant Staphylococcus aureus (MRSA), insurance claims, 687
420 learning and recovery
Methicillin-sensitive S. aureus (MSSA), 420 aviation near-miss reporting systems, 690
Michigan approach, 657 nuclear power safety systems, 690–691
Michigan Perioperative Transformation Network patients safety, 690
(MPTN), 717 quality and safety, 684
Michigan Surgical Quality Collaborative (MSQC), 717 reporting, 690
Middle-East and North Africa (MENA), 864 reporting systems, 690
Mindfulness-based stress reduction (MBSR), 217 ripe learning opportunities, 690
Mini-Cog assessment, 614 voluntary reporting systems, 684
Minimally invasive surgical suite (MISS), 666 Nepean Emergency Department Information
Mining industry (MI), 559 Management System (NEDIMS), 259, 260
Ministry of health (MOH), 853, 863 Network of Patient Safety Databases (NPSD), 81
Misidentification, 414 Neurologic system, 594
Index 899
‘Never events’ Office of clinical effectiveness (OCE), 583

adverse events, 414 Office of Court Administration (OCA), 659
characteristics, 413 Open system assumptions
device failures and misuse, 430–433 accidents and failures, 146
difficult airway, 434 adverse events and outcomes, health care, 146
failed airway, 434–435 dynamic nonevent, 146
hospitals and physicians, 413 health care systems, 146
hypothermia, 437–438 organizational and cultural interventions, 146
instrument care and reprocessing, 438–439 rational closed mechanical system, 146
medication errors, 414–416 safety challenges, 147
misidentification, 414 system safety, 146
pressure ulcers and related positioning, 416–418 transient systems, 146
surgical specimens, 436, 437 Operating room (OR), 302, 304, 306, 319–320
The New England Journal of Medicine, 737 adjusted utilization, 315
New York State Cardiac Surgery Reporting System, 820 administrative challenges, 314
Noise allocated OR time, 315
cardiovascular responses, 265 block time allocation, 315, 318–319
caregivers, 265 block time utilization, 319
clinical environments, 264 calculating, 321–322
healthcare environments, 264 case cancellation, 322
intensive care units (ICUs), 264 case scheduling, 319
medical community, 265 data, 323
operating rooms (ORs), 264 day-to-day administrative challenges, 313
patient and staff outcomes, 264 decision-making
physiological effect, 265 priorities, 320
and sound characteristics, 264 utilization-based decisions, 319–320
systems and risk management framework, 265–266 efficiency data, 313
Noncardiac surgery, 852 goals, 322
Non-host factors high utilization impact, 319
blood management, 601 limitations, decision-making, 320
collaboratives and quality improvement programs, management committee, 300–301
600 management dilemmas, 313
FTR, 600–601 managers, 313
pharmacology, 601 managing staff, 321
readmission risk factors, 601 master surgical schedule, 315
surgeon factors, 599–600 measures, 322
team factors, 600 open time, 315
Non-small-cell lung cancer (NSCLC), 8 overutilization, 315
Nontechnical skills (NTS), 195–197, 581 PACU delays, 322–323
Non-technical skills for surgeons (NOTSS), 196 productivity index, 315
Normal accident theory, 25–26 raw utilization, 315
Northern New England Cardiovascular Disease Study regular scheduled hours, 315
Group (NNE), 716, 820 released time, 315
Nosocomial/hospital-acquired pneumonias (HAPs), 454 scoring system, 323
Nuclear power safety systems, 690–691 staffing, 315, 320–321
Nurse Unit Manager (NUM), 260 surgeon block time, 317–318
time and resources, 313
turnover time, 315
O underutilization, 315
Obesity paradox, 593 Operative fixation, 650
Objective Structured Assessment of Technical Skills Operative/postoperative complication, 297
(OSATS), 195, 556 Organization for Economic Cooperation and
Objective Structured Clinical Examination (OSCE), 193, Development (OECD), 19, 786
340, 556 Organizational context
Observational Clinical Human Reliability Assessment business settings, 282
(OCHRA), 561 characteristics, 281
Observational Teamwork Assessment for Surgery factors, 281
(OTAS), 196 healthcare, 281
Observation-based methods, 564–565 healthcare and health services, 281
Observed to expected (O/E) ratios, 871 implementation leadership, 282
900 Index
Organizational context (cont.) characteristics, 577, 578

intervention, 283 comprehensive process, 657
leaders, 283 dangers of technology, 578
leadership, 282 definitions of incidents, 685, 687
measurements, 282 Donabedian’s original quality paradigm, 838
numerous current efforts, 281–282 educating and training
transformational leadership, 282 knowledge and technical skills, 303
Organizational culture, 152 perioperative services, 303
Organizational determinants of safety presentations, 303
health care organizations, 145 simulation, 304
safe and reliable care, 145 spaced education, 304
safety culture and climate, 146 executive leadership, 299
sociotechnical systems, 145 failure to rescue, 645
state of affairs, 145 governance, 579
Outcome measures, VTE, 487 health care providers, 844
Overutilization, 315 health care quality, 837
HIC, 844
human error and systems theory, 679
P IHI, 638
PACU. See Postanesthesia Care Unit (PACU) implementing protocols, 843
Pancreaticoduodenectomy, 597 individual accountability, 665
Participation bias, 688–689 individuals making decisions, 307
Partnership for patients (PfP), 600 integrating reporting systems, 687
Pascal and Fermat’s theory, 589 international classification, 684
Patient care team. See Teamwork IRS, 684
Patient-centered care (PCC), 242, 791 LMICs, 844
assessment, 94 manager, 667, 677
characteristics, 94 medical education and training programs, 853
FACIT questionnaires, 95 microsystems, 637
functional status measures, 95 organizations, 302
HRQL measures, 95 patient safety walk-rounds, 687
implementation, 95 perioperative care, 300, 308
low cost and high-value care, 94 population-based approach, 685
measurement and public reporting, 94 practices, 18
measures, 94 process, 577–578
NCCN, 95 PSI, 687
PROMIS®, 95 quality of care, 300
promote value in health, 94 reporting and learning systems, 685
symptom assessment, 95 safety protocol adherence, 301
tools, 94 SSIs, 850
Patient Centered Outcomes Research Institute (PCORI), supply issues, 578–579
733 surgical care, 624
Patient engagement. See Co-production in healthcare system redesign, 677, 678
Patient handoff systems theory, 679
communication, 626 TCIMC, 678
ICU-to-ward patient, 627 training programs, 653
OR-to-ICU, 626 VAP, 852
transitions, 628 VTE, 487
Patient harm, 689 VTECurrent multidetector helical CT, 487
Patient perspectives, HVC, 91–92 VTEDuplex ultrasound, 487
decision aids, 92 VTEDVT, 487
shared decision-making (see Shared VTEtests, 488
decision-making) VTEventilation/perfusion scan (V/Q scan), 487
2010 Patient Protection and Affordable Care Act, 786 WHO, 843
Patient safety, 207, 214, 259, 260, 303, 304, 399, 407, Patient Safety and Quality of Care, 20
737, 749, 789–790, 822 Patient safety evaluation system (PSES), 83
adverse events, 687 Patient safety indicators (PSI), 687
AHRQ, 298, 687 Patient safety organizations (PSOs), 81, 585
blame and accountability, 679 Patient safety-friendly hospital initiative (PSFHI), 861
Index 901
Patient satisfaction, 790–791 Postanesthesia care unit (PACU), 168–169, 627,

Patient-Centered Medical Home, 787 668, 791
The Patient Reported Outcomes Measurement Postoperative complications, 850
Information System, 95 Postoperative delirium, 593, 615
The Patient Safety and Quality Improvement Act of 2005 Postoperative nausea and vomiting (PONV), 355
(PSQIA), 81, 82 postoperative period, 418
Patients and families in safety improvement, 652–654 Postoperative transitions
Pediatric health information system (PHIS) errors and adverse events, 626
database, 743 ICU-to-ward patient transfer, 627, 628
Pediatric intensive care unit (PICU), 151 OR-to-ICU handoff process, 626
Pediatric Regional Anesthesia Network (PRAN), 726 OR-to-ICU transitions, 627
Peptic ulcer prophylaxis, 852 PACU, 626, 627
Per oral endoscopic myotomy (POEM), 135 shift and service handoff transitions, 628
Performance management Postoperative vision loss (POVL), 509
dash boarding and bench marking, 242 Practice Performance Assessment and Improvement
incentives and compensation, 242–243 (PPAI), 335
quality, efficiency and patient satisfaction, 241–242 Pre-compiled response, 670, 674, 676
Perioperative care, 871 Preoperative cognitive impairment, 614
anesthesia, 355 Preoperative phase
antithrombotic prophylaxis, 355 communication, 173–174
audit, 356 facility design considerations, 175
bowel movement, 356 patient experience, 175–176
discharge, 356 patient safety, 175
mobilization, 355–356 safety, efficiency and comfort, 175
patient safety, 308 specifications, optimal human performance, 176
PONV, 355 Preoperative preparation, 613
safety and quality, 298 Pressure ulcers, 416–418
Perioperative ischemic evaluation (POISE), 595 Prevention of surgical site infection, 420
Perioperative risk optimization and planning tool Prevention of venous thromboembolism (VTE).
(PROMPT™), 786 See Venous thromboembolism (VTE)
Perioperative skin and tissue injuries Principles of high reliability, 27
etiologies, 521 Proactive risk analysis, 305
investigation guidelines, 522, 523 Probabilistic risk assessment (PRA), 707–708
Perioperative surgical home (PSH), 172, 342, 630, Procedural violations, 29–30
631, 873 Process mapping, CQI, 125–128
comprehensive systematic review, 792, 793 minor and major adverse event data, 128
ERAS®, 785 operative processes, 126
health care resources, 786 postoperative processes, 127
health care value equation, 787 preoperative processes, 126
implementation, 793 Professionals in Infection Control and Epidemiology
integrated care pathways, 785 (APIC), 369
interdependent goals, 785 Prophylactic inferior vena cava filters, 483
post-hospital discharge and rehabilitation Prophylaxis, 851
phase, 785 PSFHI. See Patient safety-friendly hospital initiative
PROMPT™, 786 (PSFHI)
value-based proposition, 786–787 PSO Privacy Protection Center (PSOPPC), 82
variants/components, 785, 786 Public policy
Personal protective equipment (PPE), 370, 422 bundled payments, 818
Pharmacist, 461, 467 evidence, 817
The pharmacy and therapeutics committee (P&T), 470 factors impacting quality and costs, 819, 820
Physician quality reporting system (PQRS), 335, 723, federal government, 817
821, 824 fee-for-service model, 819
Physiological deterioration, 641 HCFA, 818, 819
Plan-Do-Check-Act (PDCA), 793 health care, 817
Plan-Do-Study-Act (PDSA), 786, 841, 870 health care cost containment, 819
Pod design, 164 Medicare program, 819
Polypharmacy, 615–616 per capital health care spending, 817, 818
Population-based approach, 685 policy makers, 819
Positioning errors, 416–418 progressive legislation, 817
902 Index
Public policy (cont.) burns, 535

societal demographic, 817 emitting medical technologies, 520
US economy, 819 energy, 519
Public reporting of VTE outcomes hazard, 537
linking process measures, 487 surgery, 529
national bodies, 486 devices, 520
pay-for-performance, 486 technologies, 520
screening , asymptomatic patients, 487 Rapid response systems (RRS)
screening practices, 486 administrative limb and structures supporting
surveillance bias, 487 education, 637
Pulmonary artery (PA), 435 afferent limb, 637
Pulmonary embolism, 851 care and clinical outcomes, 638
Pulmonary system, 594–595 CPA, 644
efferent limb, 637
failure to rescue, 637
Q generic evaluation, 643
QI. See Quality improvement (QI) health policy, 638
Qualified Clinical Data Registry (QCDR), 335, 724 IHI, 638
Quality structure, 638
AHRQ, 788 Rapid response team (RRTs), 636
factors, 789 critical care skills, 641
health care, 788 early warning score, 643
IOM, 788 impact, 643
measurement, 788 microsystems, 637
preoperative risk optimization, 789 mortality, 638
PSH, 789 performance, 639
QI, 788 surgical patients, 643
surgical microsystem, 788 Regionalization
Quality Assessment and Assurance (QAA), 225 complex surgery, 832
Quality Assessment Performance Improvement program pancreaticoduodenectomy and esophagectomy, 833
(QAPI), 364, 366 postoperative mortality, 833
Quality assurance (QA), 470, 870 quality indicators, 833
Quality assurance committee, 470 rural hospitals and regional centers, 833
Quality Clinical Data Registry (QCDR), 821 surgeons providing care, 832
Quality improvement (QI), 54, 718, 788, 801–803, Registered nurses (RNs), 428
807, 841 Regular scheduled hours, 315
Quality improvement collaborative (QIC) The Regulatory Environment, 723–725
clinical outcomes, 715 Relative value unit (RVU), 821
communities of practice, 716 Renal system, 597
complex organizational settings, 715 Reporting, 684
definition, 715 barriers, 687–688
evaluation, 719–720 culture, 685–687
evidence of effectiveness, 716 IRS (see Incident reporting systems (IRS))
ISQIC conceptual model, 718 prevent harms, 684
multifaceted interventions, 715 systems, 684, 689
nuts and bolts, 718–719 Resilience, 210, 219
quality improvement (QI), 718 benefits, 31
social learning systems, 716 definition, 30
surgical quality, 716–718 efficiency, 31
Quality improvement interventions, 484 limitations, 32
Quality Improvement Project (QIP), 600 Resilience engineering (RE), 877, 878
Quality metrics, 227, 238, 240 Resistance, minimizing and managing
Quality of life (QOL), 206 audit and feedback, 308
Quality standards, 864 desired behavior, 307
Quick response code, 578 effective leadership, perioperative quality and safety, 307
emotional connection, 307
engage emotionally, 307
R maximize efficiency, 307
Radiant warmers, 534 peer pressure and support, 307
Radiation persistent resistance, 308
Index 903
Resource Analysis Committee (RAC), 669 Root cause analysis (RCA), 329, 696, 864, 872
Resource Based Relative Value Scale adverse outcome, 674
(RBRVS), 821 blame, 676
Respiratory complications, 850 clinician interview, 670
Respiratory rate (RR), 639 CMO, 667
Resuscitation with percutaneous treatments and operative contributing factors omitted, time lines, 676
resuscitations (RAPTOR), 138 corrective action plan, 674
Retained surgical items (RSI) decades, 674
bad behavior, 428 decision making, 667
behavioral and environmental categories, 428 depth and breadth, interviews, 674
communication difficulties, 428 Evelyn’s harm, 673
factors, 427 factors, 670
general chaos, 428 faulty systems, 675
healthcare failure mode and effect analysis, 428 flawed processes, 676
perioperative surgical team, 428 frontline clinicians, 674
recommendations, 428 high-risk patients, 674
retroperitoneum/pleural cavity, 428 human error, 667, 668
RN circulator, 428 in-depth analysis, 675
Return on investment (ROI), 247 Kelly’s self-assignment, blame, 668
Risk-based process mapping, 773, 774 meeting, 668
Risk-based thinking, 773 (see also Accreditation) mental models, 673, 676
Risk domain, 68–70, 76 MISS, 668, 674
Risk management, 574–576, 690 OR 3M team, 665, 666
assess process risk, 574 organization’s fiscal viability, 669
clinical case, 571–572 PACU, 668
FMEA methodology, 576 personal accountability, 668
individual, 572–573 remediation, 667
phases of care, 573–574 respiratory therapy, 668
process, 573 retro-scope, 676
quantify risk risk management team, 665
factors, 574 screening anesthesiologist, 675
FMEA, 574 system-level fixes, 675
instrument, needle and sponge count, 575 TCIMC, 676
protamine administration process, 576 Royal Australasian College of Surgeons (RACS), 192
RPN, 574 Run charts, CQI, 127, 130
wound closure process, 575 Rural community, 828, 835
Risk manager, 677 Rural hospital, 831–835
challenges, 80 anesthesia, 829
changes, 81 barriers, 829
merger and acquisition, 81 CAH, 828
primary, 80 care system
reporting and risk data management, 81–82 measuring quality, 831–832
reporting relationships and position, 81 patient preferences and resources, 834–835
skills, 81 regionalization, 832–833
Risk priority number (RPN), 574, 575 definition, 828
Robotic surgery, 580 functional relationship, 828
ARES, 135 procedures, 833
computer-assisted telemanipulator, 133 rural health policy, 828
efficacy, 134 Rural surgeons, challenges
hurdles, 135, 136 advanced skills training, 830
laparoscopic instruments, 133 assessment, 830
miniature robots, 134 clinical and administrative roles, 828
minimally invasive procedures, 133 flipped classroom approach, 830
renal hilum, 133, 134 geographical locations, regional practices, 830
robot system, 134 integrated electronic medical record, 830
ROLARR trial, 134 mentored skills practice, 830
TME vs. laparoscopic TME, 134 professional isolation, 829, 830
tremor reduction, scaling and wristed regional health care facility, 830
articulation, 133 rural hospitals, 829
ROLARR trial, 134 upper and lower endoscopy, 829
904 Index
Rural surgeons, challenges (cont.) cognitive aids, 336

work burden and professional isolation, 830 conceptual dimensions, 298
Rural surgery continuous reinforcement and support, 300
learning modules, 830 crisis resource management (CRM), 338
life-threatening complications, 827 culture and climate, 328–329
noncommunicable diseases and injuries, 827 CUSP, 298
professional development activities, 828 departmental leadership, and executive
short-term medical missions, 827 leadership, 298
Rural urban commuting areas codes (RUCAs), 828 design and implementation, 327
effective and safe system, 327
equipment and monitoring, 329–331
S external comparative benchmarking surveys, 298
Safe medication management, 462, 465–467 healthcare system, 298, 876
adverse drug reactions, 471 high-stakes situations, 338
anesthesia, 465 human factors and performance, 342
checklist, drug administration, 462 intensive care unit (ICU), 328
clinical management, apnea, 462–464 interventions, 298
healthcare delivery systems, 461 malignant hyperthermia, 340
iatrogenic injury, 461 medical and anesthesia educators, 340
LMA, 462 medical device and medication fail-safe
look-alike drug vials, 463, 464 measures, 328
medication errors, 464–465 medical simulation, 339
reporting systems, 464 medical training, 338
wrong drug administration medication errors, 333
controlled drug management, 466–467 medication safety, 332–333
education, 467 operating room environment, 338, 876
formulary management, 466 patient care, 301
OR, 462 patient safety incidents, 328
system theory and checks, 465–466 patient transitions and handoffs, 336–338
Safe Surgery Checklist, 234 perceptions of teamwork, 876
Safety, 301, 302 perioperative safety organizations, 341
business case, 305–306 perioperative services, 298
climate, 152, 153 perioperative settings, 300
collaboration Perioperative teamwork, 338
executive leadership, 301 principles, CRM, 339
external partners, 302 PSH, 342
information technology department, 301 quality care, 328
organizational departments, 301 robust process, 301
quality and risk management departments, 301 second victim, 342
data sources, 306 strategies, 876
designing processes, 304–305 survey, 577
executive leadership, 300 sustainability, 301
hiring, 299 team competencies, 338
infrastructure designing, 298–299 team training, 876
performance appraisals, 300 team-centered systems, 300
perioperative care, 300 teams, 338
promoting norms, 300 unit-based safety program, 298
staffing plan, 302 Safety drift, 27–29
trauma center designation levels, 303 Safety Improvement for Patients in Europe (SImPatIE),
Safety culture, 152, 854 19–20
achieving and maintaining, 874 Safety management
AHRQ patient safety network, 874 anticipation/prevention, 148, 149
AIMS, 331–332 HROs, 150
airline industry, 338 proactive and preemptive analyses, 149–150
anesthesiologists, 328 resilience/containment, 149
candidate’s functional skill, 299 social and relational contexts, 150
CCAP, 333, 335 Saltzman’s levels, sensorimotor representation, 190
challenges, 874, 876 Saudi Arabia major health reform
checklists, 335–336 adverse events, 865
checklists and team briefings, 876–877 ARAMCO standards, 865
Index 905
communication challenge, 865 positive outcomes, 93

health-care accreditation, 864, 865 qualitative methods, 93
JCI, 865 research, 93
Kingdom 2030, 865 Situational awareness (SA), 44
Makkah region, 864 Six Sigma (SS), 791, 842
MRQP, 864 Skilled nursing facilities (SNF), 603
multiethnicity and multilingualism, 865 Skin and tissue injuries, 520–522, 524, 528–537
perioperative patient safety, 865 baseline information, 526
potential perioperative harm, 865 causes, 525
Saudi Aramco, 864 costs, 519
Saudi health-care market, 866 didactic training, 520
Saudi medical services organization standards, 864 dissemination of innovation, 520
SPSC’s vision, 866 electrosurgical (see Electrosurgical and electrocautery
Saudi Commission for Healthcare Specialties (SCFHS), technology)
862, 865 equipment inspection, 527
Saudi health-care system, 863 incident report documentation, 523
Saudi Patient Safety Center (SPSC), 863, 866 instructions, 528, 529
SCIP. See Surgical care improvement project (SCIP) baseline patient, 528
Scope of practice equipment information, 528
AORN, 581 injury, 528
credentialing and privileging, 579–580 patient surgical and medical records, 528
emergency equipment, sedation and analgesia, questionnaires, 528
582–583 record the interviewee’s answers, 528
equipment, 582–583 surgical procedure, 528
healthcare organization, 579 intraoperative (see Intraoperative tissue injury)
nontechnical skills, 581 intraoperative tissue injury mechanisms, 520
staff competency, 580–581 investigation (see Investigation, skin and tissue
surgical setting, 581–582 injuries)
trust and good communication skills, 579 lesion assessment, 526–527
Scrub Practitioners’ List of Intraoperative Non-Technical patient and family discussion, 524
Skills (SPLINTS), 196 perioperative setting, 519
The second victim perioperative treatment/monitoring, 519
angry physician, 584–585 preventive recommendations, 519
elements, 585 questionnaire, 538–546
error disclosure, 583 surgical patient safety, 520
impairment types, 585–586 technology, 520
OCE, 583 therapeutic and monitoring technologies, 519
personal impact, 584 thermal injuries, 532–533
practitioner, 583 warnings and precautions, 520
professional impact, 584 Social Security Death Master File (SSDMF), 743
systematic improvements, 583 Society of American Gastrointestinal and Endoscopic
thoughts, 584 Surgeons (SAGES), 136, 423, 580
UMHC, 584 Society of Gastroenterology Nurses and Associates
Sensemaking, 684 (SGNA), 469
Sentinel event (SE), 864, 866 Society for Healthcare Epidemiology of America
Sepsis six, 643 (SHEA), 369, 456, 850
Serious reportable events (SRE), 341 Society of Thoracic Surgeons (STS), 821
Shared decision-making, 92, 93, 791 Society of Thoracic Surgeons National Cardiac Database
clinicians function, 91 (STS-NCD), 8, 590, 739, 820
guidance, 91 Spaced education (SE), 304
implementation, value-based care, 91 Splanchnic system, 596–597
patient- and family-centered outcomes, 91 SPSC. See Saudi Patient Safety Center (SPSC)
patient knowledge and understanding, 91 Staff meetings, 300
patient participation, 91 Staffing, 302, 315, 320–321
physician competencies, 91 Standard Nomenclature in Medicine, 731
treatments, 91 Standardization of vital sign, 640
and value-based care Staphylococcus aureus, 420, 454
barriers, 92 Statement of awarded responsibility (STAR), 197
interactions with patients, 93 Statistical process control (SPC) chart, 870, 872
open communication and transparency, 93 Status hierarchy barriers, 854
906 Index
Steep Trendelenburg, 497 Surgical complications, 849

Sterile core design, 164 Surgical database
STS Adult Cardiac Surgery Database (ACSD), 739 common language and nomenclature, 739
STS Congenital Heart Surgery Database (CHSD), 739 data collection, 742–743
STS General Thoracic Surgery Database (GTSD), 739 graphical depiction of outcomes data, 745–749
Study on the Efficacy of Nosocomial Infection Control lifelong follow-up, 743
(SENIC), 851 mechanism, 742
Surgeon block time, 317–318 medical and surgical subspecialties, 743
Surgeon specific reporting (SSR), 590 quality assessment and quality improvement,
Surgeons’ leadership inventory (SLI), 196 743–745
Surgery uniform core dataset for collection of information,
complications, 849 739–742
decision-making, 399 Surgical microsystems, 34–35
definitions, diagnostic error, 398 Surgical performance
operating room, 137–139 assessments, 558
tissue engineering and nanosurgery, 133 causes and characteristics, 564
Surgical care, 850 observational methods, 564
adverse cardiac events, 852 OR, 562
anesthesia, 850 scored sheet, 562
avoidable errors, 5, 6 surgeons’ consistency and patient outcomes, 556
certain process measures, 9 thermo-physiological stress, 558
disparities, 8 traditional observer-based measures, 557
evidence-based medicine and tools, 4 Surgical positioning
healthcare systems, 3 air-assisted transfer device, 500, 502
healthcare team, 4 anatomy and physiology, 493–494
iatrogenesis, 3 areas prone to pressure, 500, 504
Institute of Medicine’s, 4 90° arm placement, 501, 505
MDTs, 852 bariatric assist device, 515, 516
medical error and adverse events, 3 candy cane stirrups, 511, 512
multidisciplinary approach, 853 equipment and positioning injuries, 496
multidisciplinary collaboration, 852 factors, 493
nosocomial conditions, 3 lateral position, 513–515
numerous studies, 4 lawn/beach chair position, 502, 506
outcome measures, 9 lithotomy position, 510–513
overuse, 7 mechanical device with support sling, 513
patient comorbidity, 4 mechanical lift with supine sling, 500, 503
patient safety, 4–5 nerve injuries types, 497, 498
psychological research, 852 nerves, risk for injury, 511, 512
quality, 4, 8 obese patient, 515
RAND Corporation analysis, 3 objectives, patients, 493
safe surgery, 850 operating room mattress, 494, 495
safety and quality, 849 padding, 507
SCIP, 850 patient factors, 507
SSI (see Surgical site infections (SSI)) positioning devices, 508
surgical patient safety, 10 positioning equipment, 494–496
surgical safety, 9 preoperative assessment, 496
system threats, 5 prevention, 493
underuse, 8 products, slipping prevention, 505, 507
VAP, 852 prone position, 509–510
variation, 6–7 reverse Trendelenburg position, 504, 506
VTE, 851 risk factors, 494
Surgical Care and Outcomes Program (SCOAP), 717 safety considerations, 497–500, 515–517
Surgical care improvement project (SCIP), 341, 420, safety straps, 515, 516
454, 850, 869–871 sitting position, 500, 503
Surgical checklists skin assessment, 496–497
early support, 284 slider board, 500–502
evidence, 284–285 stirrups types, 511
implementation, 284 supine position, 499–504
incomplete plan, 285–286 surgery and innovative technologies, 493
Surgical Clinical Reviewer (SCR), 741 surgical safety checklist, 508
Index 907
team communication, 508–509 active and direct feedback, 851

Trendelenburg position, 504–507 antibiotics, 420
tucking the arms, 501, 504 antimicrobial therapy, 454
Surgical quality, 841, 842 AORN guidelines, 422
CAHs, 831 awareness, 850
clinical effectiveness, 837 bacteria, 420
components, 835 classification, 453
HICs, 844 effectiveness, 421
high-volume outpatient procedures, 831 evidence-based strategies, 850
measures, 831 global preventive intervention programs, 850
patient experience, 837 HAIs, 453
patient safety, 837 health care-associated infections, 850
QI hypothermia, 422
definitions, 841 mortality and morbidity, 850
methodologies, 841, 842 normothermia and euglycemia, 454
variation and error, 841 optimal surgical environment, 422
regional health system, 835 patient characteristics, 420
regionalization, 828 patients and staff, 421
Surgical quality officer physical environment, 422
administrative roles and outcome researchers, 243 postoperative care, 422, 423
alignment and leadership, 231 PPE, 422
continuous improvement training and support, preoperative patient factors, 420
238–239 prevention, 454, 850
culture of safety, 232–235 preventive measures, 454
culture of surgical safety, 226 prophylactic antimicrobial agents, 420
data analytics and validation, 235 risk factors, 453
innovation, 239–241 risk stratification models, 454
metric development and goal setting, 235–238 safety measure, 421
Patient Safety Officer, 226–227 SCIP, 850
process improvement, 225 skin antiseptics, 420, 421
quality assessment, 225 strong for surgery team, 420
quality leaders, 243–244 surgical complication, 418
reporting structure and administrative committee surgical incision site, 421
support, 227–230 surgical instruments, 422
training and resources, 227 surgical wound classifications, 422
Surgical registry data team members, 421
ACS NSQIP and the STS National Database, 738 transmissible infections, 422
healthcare, 737, 738 WHO recommendations, 850
outcomes, quality, and safety, 737, 738 WHO surgical safety checklist, 850
structure, process, and outcome, 737, 738 wound classification, 423
Surgical safety Surgical skills assessment, 556–558
health care delivery system, 869 observation-based methods
multidisciplinary care teams, 869 global rating scales, 556, 557
nontechnical skills, 869 OSATS, 556
surveillance and monitoring, 20–21 task- and procedure-specific checklists, 556
WHO checklist, 625–626 technology-based performance measures
Surgical Safety Checklist (SSC), 843 attention monitoring technology, 557–558
Surgical scheduling accuracy, 625 motion analysis, 557
Surgical services physiologic stress monitoring, 558
assessment and regulation, 769 Surgical specimen errors, 413, 436, 437
development and application, 769–770 Surgical technologists (STs), 428
international regulatory and quality assurance Surgical Unit-Based Safety Program (SUSP), 454
schemes, 756–767 Surgical Ward care Assessment Tool (SWAT), 196
National vs. International current assurance schemes, Surgical Wound Classification Decision Tree, 423
756–768 Surveillance bias, VTE, 487
outpatient/ambulatory surgery, 768 Sustainability, 299, 301
quality of care, 756 Sustainable growth rate (SGR), 823
risk and impacts, 769 System insight, 712
systems thinking and surgical safety, 755–756 System redesign, 678, 679
Surgical site infections (SSI), 593, 849 Systemic inflammatory response syndrome, 641
908 Index
Systems of care U
organizational structure, 602 Ulnar nerve, 497, 499
peri-surgical home, 601–602 Underuse, 8
process, 602–603 Underutilization, 315
Unit-based safety program, 298
United States Institute of Medicine (IOM), 822
T United States of International Classification of Diseases,
Team briefings, 876–877 version 10 (ICD-10), 731
Team effectiveness model (ITEM), 55 United States’ Medicare program, 590
Team resource management (TRM) Programme, 382 University Healthsystem Consortium (UHC), 306
Team Strategies and Tools to Enhance Performance and University of Michigan Health System (UMHS), 656
Patient Safety (TeamSTEPPS), 876 University of Missouri Health Care (UMHC), 583
Team training, 338, 339, 343, 876 Urinary Catheter, 354–355
Team-based approach, 852 Urinary tract infection (UTI), 450
TeamSTEPPS 2.0®, 60 U.S. Army After Action Review (AAR), 329
TeamSTEPPS™, 193, 406 US Centers for Disease Control and Prevention (CDC), 5
Teamwork, 715, 755 US Department of Health and Human Services (HHS),
cognitive structures and behavioral norms, 54 449
communication, 51–53 U.S. Food and Drug Administration (FDA), 330
definition, 52 US National Institutes of Health Fogarty International
effective teaming, 56–60 Center (FIC), 286
effective, efficient and safe surgery, 54 Use of Surgical Registry Data to Improve Outcomes, 737
expert teams, 52 Utilization-based decisions, 319–320
healthcare-specific models, 55–56
interventions, 60–62
intraoperative surgical teams, 54 V
medical errors, 51 Value-based health care, 790
membership and team life span considerations, 58–60 Value-based program (VBP), 471
multidisciplinary team, 54 Valvular heart disease, 595
multi-team systems (MTSs), 54 Vancomycin, 452
nontechnical skills, 52 VAP. See Ventilator associated pneumonia (VAP)
surgical teams, 54 Vascular Study Group Cardiac Risk Index (VSG-CRI),
systems-oriented lens, 51 595
team-based work, 54 Vascular Study Group of New England (VSGNE), 595
and teams, 55–56 Venous air embolus (VAE), 435
teaming processes, 54 Venous thromboembolism (VTE), 355, 482–486, 851
Telementoring, 137 AHRQ, 480
Telesurgery, 137 chronic thromboembolic pulmonary hypertension,
Tennessee Surgical Quality Collaborative (TSQC), 717 481
The Joint Commission (TJC), 577 DVT, 479, 480
Thermal burn injuries, 534 guidelines, 480
Thermoregulation, 592–593 healthcare quality and patient safety, 479, 488
Thromboembolic complications, 849 incidence and cost, 481
Thromboembolism, 850 outcome measure, 480
Thromboprophylaxis, 852 patient safety and quality care, 480
Tissue engineering, 139–140 post-thrombotic syndrome, 481
TJC Universal Protocol, 577 prevention
Top-down approach, 298 administration, 485
Total mesorectal excision (TME), 134 computer order entry system, 484
Tower of Babel of terminology, 461 framework, 484
Traditional layout, 164 guideline-appropriate prophylaxis, 484
Training, 193–194 inferior vena cava (IVC) filters, 483
Transesophageal echocardiography (TEE), 435 interventions, 485
Transitions of Care, 801 mechanical prophylaxis, 483
Transparency, 651, 655, 656 obstacles, hospital culture, 486
healthcare, 105, 110 patient engagement and education, 485–486
safety measures, 105 pharmacologic prophylaxis, 482–483
Traumatic injury, 138 risk-appropriate VTE prophylaxis, 485
Triple aim of health care, 785 risk status and compliance, 484
Tumor-infiltrating T-lymphocytes, 140 prophylaxis, 479, 480
Index 909
public health and safety problem, 480 healthy mind platter

Public reporting and pay-for-performance (see Public connecting time, 217–218
reporting of VTE outcomes) downtime, 216–217
pulmonary embolism (PE), 479 focus time, 218, 219
quality and safety, 487–488 physical time, 218
RIETE registry, 481 play time, 216
risk factors, 481–482 sleep time, 215
submassive/intermediate-risk PE, 481 time-in (reflection, attunement and mindfulness),
tools, 480 217
Ventilation, 330 human dilemma, 210
Ventilator-associated pneumonias (VAPs), 455, 852 integration and window of tolerance, 213–214
Ventilator bundle, 852 intra- and interpersonal, 211
Veteran Health Administration (VHA), 234, 283, 789 joy and playfulness, 210
Veterans Administration (VA), 578 leadership and team trainings, 219
Veterans Affairs Medical Center, 656 mechanical vs. complex adaptive systems, 214–215
VHA Surgical Quality Improvement Program (VASQIP), programs, 210
600 release yourself and unnecessary judgements
Video feedback embrace joy and gratitude, 220–221
automated vs. handheld video feedback, 384–387 photographic proof, 221
aversion to Error Reporting, 383–384 witch hunt, 220
awareness of risks, 382 research behind wellness, 211–213
preliminary outcomes, cataract surgery, 387–388 resilience, 210
sensomotor and non-technical factors, 381–382 self-denial, 210
social orientation, 384 thrive—qualities, 219
TRM programme, 382 work–life balance, 211
videotaping team activities, 382 WHO Surgical Safety Checklist, 625–626, 861
Virginia Cardiac Surgery Quality Initiative (VCSQI), WHO/World Alliance for Safer Healthcare, 15
591, 820 Windows, icons, menus, pointers (WIMPS), 40
VISITOR1® mobile telementoring system, 137, 138 Work–life balance, 211
VTE prophylaxis protocol, 851–852 Work life flexibility, 212
Workplace learning, 707
Workstation, 329
W World Health Organisation (WHO), 16, 263, 264, 577,
Wake Up Safe (WUS), 726 755, 756, 789, 827, 837
Washington, Wyoming, Alaska, Montana, and Idaho ‘Wound vacs’, 598
(WWAMI), 828 wrong patient, 413, 414, 416
Wellness, 215–221 Wrong procedure patient errors (WSPE), 177
burnout and distress, 210 Wrong-site surgery, 773, 774

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Surgical

Julie K. Johnson Jeffrey P. Jacobs

ISBN 978-3-319-44008-8 ISBN 978-3-319-44010-1 (eBook)

Library of Congress Control Number: 2016956252

© Springer International Publishing Switzerland 2017

Printed on acid-free paper

This Springer imprint is published by Springer Nature

hospital within 30 days with postoperative complications. Of the readmis-

Healthcare is highly regulated by government agencies, insurers, and vol-

Sir Liam Donaldson

the discussions of governance, culture, safety management systems, safe-

Just as we measure the voice of the patient to understand how we are

Fig. 1 High-reliability organizations and their organizational culture*

that appreciates the relationships among a variety of organizational and tech-

PART II PART III PART IV

Fig. 2 Conceptual model.

the impact of human factors and systems effects in improving outcomes in

In addition, the evolving regulatory environment employs strategies

To my parents David and Marilyn Jacobs for giving me the opportunity, to my

Part I Fundamentals of Systems and Safety Science

1 The Burning Platform: Improving Surgical Quality

Part II Job and Organizational Design

Part III Perioperative Quality and Patient Safety

23 The Next Frontier: Ambulatory and Outpatient

Part IV Approaches to Managing Risks

37 Failure to Rescue and Failure to Perceive Patients in Crisis ���� 635

Part V Regulation, Policy, and the Future of Surgical Care

50 Global Surgery: Progress and Challenges in Surgical Quality

Juan A. Sanchez, MD, MPA, FACS, FACHE is Chair of Surgery at

Paul Barach, MD, MPH is a Clinical Professor at Wayne State University

Julie K. Johnson, MSPH, PhD is a professor in the Department of Surgery

Jeffrey P. Jacobs, MD, FACS, FACC, FCCP is Chief of the Division of

Gregory A. Aarons, PhD Department of Psychiatry, UC San Diego School

Bryce R. Cassin, RN, BA Hons (Class 1) School of Nursing and Midwifery,

Scott J. Ellner, DO, MPH, MHCM, FACS Centura Health Physician

Maurice F. Joyce, MD, EdM Department of Anesthesiology, Tufts Medical

James Merlino, MD Press Ganey Associates, Strategic Consulting, Chicago,

Nick Sevdalis, BSc, MSc, PhD Health Service & Population Research,

Sanjana Vig, MD, MBA Department of Anesthesiology, Stanford Hospitals

need and others receive less, and yet others get

© Springer International Publishing Switzerland 2017 3

ogy or methods for which there is no evidence or

practice guidelines and other tools which pro-

Effective care occurs when the benefits of an

Underuse to medications with devastating effects [71, 81]. In

events (i.e., surgical infections) makes a causal

omission. Others suggest a broader definition that

© Springer International Publishing Switzerland 2017 15

related to airway problems or anaesthesia in the

Table 2.2 (continued) delivery of optimal care and indicates substantial

References 17. Cima RR, Kollengode A, Garnatz J, et al. Incidence

Introduction Normal Accident Theory

© Springer International Publishing Switzerland 2017 25

If a system perceives future events to be a phe- Principles of High Reliability

57. La Porte TR. A strawman speaks up: comments

[2], combined with understanding of human psy-

© Springer International Publishing Switzerland 2017 39

seeking to mimic human activities—such as presumably, in the absence of visual cues at

1 The Burning Platform: Improving Surgical Quality

23 The Next Frontier: Ambulatory and Outpatient

37 Failure to Rescue and Failure to Perceive Patients in Crisis �� 635

50 Global Surgery: Progress and Challenges in Surgical Quality

Underuse to medications with devastating effects [71, 81]. In

Introduction Normal Accident Theory

If a system perceives future events to be a phe- Principles of High Reliability

surprising and perhaps counterintuitive effects of Human Factors in Device Design

c ommunication failures, absences of staff, equip- processes and performance-shaping factors in

national accreditation organization tracking senti- efining Teams, Teamwork,

c ommunication also become more important in Building on these conceptual advancements,

embership and Team Life Span

how risk should be in surgical services. Although isk Management in Healthcare

edicolegal Aspects of Patient

Common Formats Value to Providers

Abbreviations HCAHPS Hospital Consumer Assessment of

Patient Experience of Care quality of healthcare delivery from the patient’s

Measuring Quality in Surgical Care health and healthcare planning. Incorporating

Foundation and the community-based model of productive—patient relationships are needed in

afety in Health Care: The Role

receding chimera, observable only when it ceases Conclusion

Suite Layouts moving clean materials to the ORs and return-

Suite Layout Characteristics

Communications in the OR included here. The Methodist desk (Fig. 12.11)

Universal ORs If planned during design, the steps needed for