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Charles Vincent
René Amalberti
Safer Healthcare
Strategies for
the Real World
Safer Healthcare
Charles Vincent • René Amalberti
Safer Healthcare
Strategies for the Real World
Charles Vincent René Amalberti
University of Oxford Haute Autorité de Santé
Oxford, United Kingdom Paris, France
This work is supported by the Health Foundation, an independent charity working to improve
the quality of healthcare.
Open Access This book is distributed under the terms of the Creative Commons Attribution
Noncommercial License, which permits any noncommercial use, distribution, and reproduction in any
medium, provided the original author(s) and source are credited.
All commercial rights are reserved by the Publisher, whether the whole or part of the material is
concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting,
reproduction on microfilms or in any other physical way, and transmission or information storage and
retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known
or hereafter developed.
The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication
does not imply, even in the absence of a specific statement, that such names are exempt from the relevant
protective laws and regulations and therefore free for general use.
The publisher, the authors and the editors are safe to assume that the advice and information in this book
are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the
editors give a warranty, express or implied, with respect to the material contained herein or for any errors
or omissions that may have been made.
Healthcare has brought us extraordinary benefits, but every encounter and every
treatment also carries risk of various kinds. The known risks from specific treatments
are well established and routinely discussed by clinicians. Yet we also face risks
from failures in the healthcare system, some specific to each setting and others from
poor coordination of care across settings. For us, as patients, healthcare provides an
extraordinary mixture of wonderful achievements and humanity which may be
rapidly followed by serious lapses and adverse effects.
Patient safety has been driven by studies of specific incidents in which people
have been harmed by healthcare. Eliminating these distressing, sometimes tragic,
events remains a priority, but this ambition does not really capture the challenges
before us. While patient safety has brought many advances, we believe that we will
have to conceptualise the enterprise differently if we are to advance further. We
argue that we need to see safety through the patient’s eyes, to consider how safety is
managed in different contexts and to develop a wider strategic and practical vision
in which patient safety is recast as the management of risk over time.
The title may seem curious. Why ‘strategies for the real world’? The reason is
that as we developed these ideas we came to realise that almost all current safety
initiatives are either attempts to improve the reliability of clinical processes or wider
system improvement initiatives. We refer to these as ‘optimising strategies’, and
they are important and valuable initiatives. The only problem is that, for a host of
reasons, it is often impossible to provide optimal care. We have very few safety
strategies which are aimed at managing risk in the often complex and adverse daily
working conditions of healthcare. The current strategies work well in a reasonably
controlled environment, but they are in a sense idealistic. We argue in this book that
they need to be complemented by strategies that are explicitly aimed at managing
risk ‘in the real world’.
We are friends who have been passionate about safety for many years. We did not
meet however until we were invited as faculty members to the memorable Salzburg
International seminar on patient safety organised by Don Berwick and Lucian Leape
in 2001.
vii
viii Preface
The story of the book began in late 2013 with René’s observation that the huge
technological and organisational changes emerging in healthcare would have con-
siderable implications for patient safety. Charles suggested that care provided in the
home and community were an important focus and we planned papers addressing
these subjects. We began to speak and meet on a regular basis, evolving a common
vision and set of ideas in numerous emails, telephone calls and meetings. It quickly
became evident that a new vision of patient safety was needed now, and that the
emerging changes would just accelerate the present requirements. We needed a
book to express these ideas in their entirety.
The particular characteristic of this book is that it has been really written by ‘four
hands’. In many jointly written books, chapters have clearly been divided between
authors. In contrast, we made no specific allocations of chapters to either of us at
any point. All chapters were imagined and developed together, and the ideas tested
and hammered into shape by means of successive iterations and many discussions.
The work matured slowly. The essential ideas emerged quite quickly but it was
challenging to find a clear expression, and the implications were much broader than
we had imagined. We were also determined to keep the book short and accessible
and, as is widely recognised, it is much harder to write a short book than a long one.
We completed a first draft in April 2015 which was read by generous colleagues and
presented to an invited seminar at the Health Foundation. We received encourage-
ment and enthusiasm and much constructive comment and criticism which helped
us enormously in shaping and refining the final version which was delivered to
Springer in August 2015.
In the first chapter of this book, we set out some of the principal challenges we face
in improving the safety of healthcare. In the second, we outline a simple framework
describing different standards of healthcare, not to categorise organisations as good
or poor, but suggesting a more dynamic picture in which care can move rapidly from
one level to another. We then argue that safety is not, and should not, be approached
in the same way in all clinical environments; the strategies for managing safety in
highly standardised and controlled environments are necessarily different from those
in which clinicians must constantly adapt and respond to changing circumstances.
We then propose that patient safety needs to be seen and understood from the per-
spective of the patient. We are not taking this perspective in order to respond to pol-
icy imperatives or demands for customer focus but simply because that is the reality
we need to capture. Safety from this perspective involves mapping the risks and
benefits of care along the patient’s journey through the healthcare system.
The following chapters begin to examine the implications of these ideas for
patient safety and the management of risk. In Chap. 5, we build on our previous
understanding of the analysis of incidents to propose and illustrate how analyses
across clinical contexts and over time might be conducted. The role of the patient
and family in selection, analysis and recommendations is highlighted.
Preface ix
We gained great encouragement from the initial responses to an earlier draft of the
book. We also received a host of ideas, suggestions and insightful comments which
illuminated specific issues or identified flaws, infelicities and things that were just
plain wrong. Where we have included specific quotes or examples provided by indi-
viduals we have cited them in the text, but all the comments we received were valu-
able and led to important changes to both the structure and the content of the book.
The book you see today is very different from the draft originally circulated. We
would like to thank the following people for their insights, suggestions and construc-
tive criticism: Jill Bailey, Nick Barber, Maureen Bisognano, Jane Carthey, Bryony
Dean Franklin, John Green, Frances Healey, Goran Henriks, Ammara Hughes, Matt
Inada Kim, Jean Luc Harousseau, John Illingworth, Martin Marshall, Phillipe
Michel, Wendy Nicklin, Penny Pereira, Anthony Staines and Suzette Woodward.
The Health Foundation is remarkable in encouraging the development of new
ideas and giving people the freedom and time to attack challenging problems. We
thank the Health Foundation for their enthusiasm and support for this book. Charles
would in particular like to thank Jennifer Dixon, Nick Barber, Jo Bibby, Helen Crisp
and Penny Pereira for enabling a career transition and for their personal support and
encouragement over many years. Michael Howes brought life and colour to our
tentative figures. We thank Nathalie Huilleret at Springer for her enthusiasm for the
project, her personal oversight of publication and her willingness and encourage-
ment to make this book Open Access and available to all.
Charles Vincent
René Amalberti
Oxford and Paris
August 2015
xi
Contents
xiii
xiv Contents
Risk Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Control of Medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Potential for ‘Go and No-Go’ Controls in Surgery. . . . . . . . . . . . . . . . 80
Placing Limits on Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Monitoring, Adaptation and Response . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Patients and Families as Problem Detectors . . . . . . . . . . . . . . . . . . . . . 82
Team Training in Monitoring, Adapting and Response . . . . . . . . . . . . 83
Briefings and Debriefings, Handovers and Ward Rounds. . . . . . . . . . . 83
Mitigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Support Systems for Staff and Patients . . . . . . . . . . . . . . . . . . . . . . . . . 84
Regulatory and Political Determinants of Approaches
to Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Safety in Context: The Many Hospital Environments . . . . . . . . . . . . . . . . 87
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
8 Safety Strategies for Care in the Home . . . . . . . . . . . . . . . . . . . . . . . . . 93
An Ageing Population and the Expansion of Home Care . . . . . . . . . . . . . 93
The Challenges of Delivering Healthcare in the Home . . . . . . . . . . . . . . . 94
The Hazards of Home Care: New Risks, New Challenges . . . . . . . . . . . . 95
Accidental Injury in the Home . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Adverse Events in Home Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Adverse Drug Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Risk to Family and Other Care Givers . . . . . . . . . . . . . . . . . . . . . . . . . 96
Problems of Transition and Coordination . . . . . . . . . . . . . . . . . . . . . . . 97
Influences on Safety of Healthcare Delivered in the Home. . . . . . . . . . . . 97
Socio-economic Conditions Take on a Much
Greater Importance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
The Home Environment as Risk Factor . . . . . . . . . . . . . . . . . . . . . . . . 98
Increasing Responsibilities of Carers . . . . . . . . . . . . . . . . . . . . . . . . . . 98
The Training and Experience of Home Care Aides . . . . . . . . . . . . . . . 100
Fragmented Approach of Healthcare Professionals . . . . . . . . . . . . . . . 100
Safety Strategies and Interventions in the Home . . . . . . . . . . . . . . . . . . . . 100
Optimization Strategies in Home Care: Best Practice
and System Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Discharge Planning and the Journey from Hospital to Home. . . . . . . . 102
Training of Patients and Carers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Risk Control Strategies in Home Care. . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Monitoring, Adaptation and Response Strategies in Home Care . . . . . . . 104
Detecting Deterioration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Mitigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
The Responsibilities of Carers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Mitigation Strategies in Home Haemodialysis . . . . . . . . . . . . . . . . . . . 107
Reflections on Home Care Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
xvi Contents
xvii
Progress and Challenges for
Patient Safety 1
Twenty-five years ago the field of patient safety, apart from a number of early pio-
neers, did not exist and the lack of research and attention to medical accidents could
reasonably be described as negligent (Vincent 1989). There is now widespread
acceptance and awareness of the problem of medical harm and, in the last decade,
considerable efforts have been made to improve the safety of healthcare. Progress
has however been slower than originally anticipated and the earlier optimism has
been replaced by a more realistic longer-term perspective. There has undoubtedly
been substantial progress but we believe that future progress, particularly in the
wider healthcare system, will require a broader vision of patient safety. In this chap-
ter we briefly review progress on patient safety and consider the principal future
challenges as we see them.
With the massive attention now given to patient safety it is easy to forget how dif-
ficult it was in earlier years to even find clear accounts of patient harm, never mind
describe and analyse them. Medico-legal files, oriented to blame and compensation
rather than safety, were the principal source of information (Lee and Domino 2002).
In contrast narrative case histories and accompanying analyses and commentary are
now widely available. Analyses of incidents are now routinely performed, albeit
often in a framework of accountability rather than in the spirit of reflection and
learning.
Major progress has been made in assessing the nature and scale of harm in many
countries. The findings of the major record review studies are widely accepted
(de Vries et al. 2008) and numerous other studies have catalogued the nature and
extent of surgical adverse events, infection, adverse drug events and other safety
issues. The measurement and monitoring of safety continues to be a challenge but
progress has been made in developing reliable indicators of safety status (Vincent
et al. 2013, 2014).
We agree with those who seek to provide a more positive vision of safety (Hollnagel
2014). The punitive approach sometimes taken by governments, regulators and the
media is, for the most part, deeply unfair and damaging. Healthcare while enor-
mously beneficial is, like many other important industries, also inherently hazard-
ous. Treating patients safely as well as effectively should be regarded as an
achievement and celebrated.
We make no apologies however for continuing to focus on harm as the touch-
stone for patient safety and the motivation for our work. We will put up with errors
and problems in our care, to some extent at least, as long as we do not come to harm
4 1 Progress and Challenges for Patient Safety
and the overall benefits clearly outweigh any problems we may encounter. Many
errors do not lead to harm and may even be necessary to the learning and mainte-
nance of safety. Surgeons, for example, may make several minor errors during a
procedure, none of which really compromise the patient’s safety or the final out-
come of the operation.
Patient safety, particularly the large scale studies of adverse events, has its ori-
gins in a medico-legal concept of harm. We have, for the most part, now separated
the concept of harm from that of negligence which is an important achievement,
though we still tend to think of safety as being the absence of specific harmful or
potential harmful events (Runciman et al. 2009). Harm can also result from loss of
opportunity due to a combination of poor care and poor coordination whether
inside the hospital, at the transition with primary care, or over a long period of
time in the community. Evidence is growing that many patients suffer harm, in the
sense that their disease progresses untreated, through diagnostic error and delay
(Graber 2013; Singh et al. 2014). In some contexts, this would simply be seen as
poor quality care falling below the accepted standard. But for the patient a serious
failure can lead to untreated or unrecognised disease and, from their perspective,
to harm.
All these are reasonable objectives but they are subtly different. We sug-
gest that the central aim must be to prevent or at least reduce harm to patients,
while acknowledging that the concept of harm is difficult to define and other
objectives are also valid. As the book develops we will suggest that the most
productive way to approach patient safety is to view it as the management of
risk over time in order to maximise benefit and minimise harm to patients in
the healthcare system.
Safety Is a Moving Target 5
We believe that the current focus on specific incidents and events is too narrow
and that we need to think about harm much more broadly and within the overall
context of the benefits of treatment. As the book evolves, we endeavour to develop
a different vision which is more rooted in the experience of patients. As patients, the
critical question for us is to weigh up the potential benefits against the potential
harms which may, or may not, be preventable. While we certainly want to avoid
harmful incidents, we are ultimately concerned with the longer term balance of
benefit and harm that accrues over months or years or even over a lifetime.
Patient safety has evolved and developed in the context of hospital care. The under-
standing we have of the epidemiology of error and harm, the causes and contribu-
tory factors and the potential solutions are almost entirely hospital based. The
concepts which guided the study of safety in hospitals remain relevant in primary
and community care but new taxonomies and new approaches may be required in
these more distributed forms of healthcare delivery (Brami and Amalberti 2010;
Amalberti and Brami 2012).
Care provided in a person’s home is an important context for healthcare delivery
but patient safety in the home has not been addressed in a systematic manner. The
home environment may pose substantial risks to patients, greater in some cases than
in the hospital environment. Safety in the context of a patient’s home care is likely
to require different concepts, approaches and solutions to those developed in the
hospital setting. This is because of the different environment, roles, responsibilities,
standards, supervision and regulatory context in home care. Critical differences are
that patients and carers are autonomous and are increasingly taking on professional
roles; they rather than the professional become the potential source of medical error.
Additionally, stressful and potentially hazardous conditions, such as poor lighting,
mean that socio-economic conditions take on a much greater importance.
In both primary care and care at home the risks to patients are rather different
from those in hospital, being much more concerned with omissions of care, failure
to monitor over long time periods and lack of access to care. These areas have not
traditionally fallen within the area of patient safety but are undoubtedly sources of
potential harm to patients. The concept of the patient safety incident, and even of
adverse events, breaks down in these settings or is at least stretched to its limit.
Suppose, to take just one example, a patient is hospitalised after taking an incorrect
dose of warfarin for 4 months. The admission to hospital could be viewed as an
incident or a preventable adverse event. This description however hardly does jus-
tice to 4 months of increasing debility and ill health culminating in a hospital admis-
sion. In reality, the admission to hospital is the beginning of the recovery process
and a sign that the healthcare system is at last meeting the needs of this patient. The
episode needs to be seen not as an isolated incident but as an evolving and pro-
longed failure in the care provided to this person.
‘But we are not like aviation’ someone will inevitably say in any discussion of the
value of learning from commercial aviation and comparing approaches to safety in
different sectors. Well no, healthcare is not like aviation in any simple sense. But
some aspects of healthcare are comparable to some aspects of aviation. An surgical
operation does not have a great deal in common with a commercial flight but the
pre-flight checking process is comparable to the pre-operation checking process and
so learning how aviation manages those checks is instructive.
Our Model of Intervention Is Limited 7
The most dramatic safety improvements so far demonstrated have been those with
a strong focus on a core clinical issue and a relatively narrow timescale. These inter-
ventions, such as the surgical safety checklist and the control of central line infec-
tions, are of course far from simple in the sense that they have only succeeded
because of a sophisticated approach to clinical engagement and implementation.
More general system improvements may extend to an entire patient pathway. For
instance the introduction of the SURPASS system using checklists and other
improvements to communication along the entire surgical pathway and showed a
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