Introduction To Quality Management: Outline

1
Introduction to Quality Management
OUTLINE
Standards, Regulations, and Quality Management, 3 Patient Comfort, 13
History of Quality Management in Diagnostic Imaging, 3 Personnel Performance, 13
Governmental Action, 4 Record-Keeping System, 13
The Joint Commission, 8 Corrective Action, 13
Det Norske Veritas Healthcare, 8 Risk Management, 13
Quality Assurance, 8 Risk Analysis, 14
Quality Control, 9 Policies and Procedures, 15
Continuous Quality Improvement, 9 Radiation Safety Program, 15
Process Improvement Through Continuous Quality Patient Radiation Protection, 16
Improvement, 10 Radiographic Examinations, 16
Key Quality Characteristics, 11 Fluoroscopic Examinations, 17
Key Process Variables, 11 Visitor Protection, 19
Components of a Quality Management Program in Personnel Protection, 20
Diagnostic Imaging, 12 Time, 21
Administrative Responsibilities, 12 Distance, 21
Threshold of Acceptability, 13 Shielding, 21
Communication Network, 13
OBJECTIVES
At the completion of this chapter, the reader should be able • Identify the five steps of a process
to do the following: • List the basic administrative responsibilities of a quality
• Identify the need for quality management in diagnostic management program
imaging • Describe the various components of a risk management
• Discuss the impact of government regulation and The program
Joint Commission accreditation on quality management • Describe the radiation safety protocols for patients and
• Explain the differences between quality assurance, quality radiation personnel
control, and quality management
KEY TERMS
Accreditation Expectation Medicare Improvements for Patients
Achievable dose Health Information Technology for and Providers Act
Action Economic and Clinical Health Act Output
American Recovery and Incident Patient dose tracking
Reinvestment Act Input Patient Protection and Affordable
Appropriateness of care Kerma area product Care Act
As low as reasonably achievable Loss potential Process
Cost of quality Mammography Quality Standards Protecting Access to Medicare Act
Customer Reauthorization Act of 2014
Deficit Reduction Act Meaningful use rules Quality assessment
Diagnostic Reference Levels Medicare Access and Children’s Quality assurance
Dose area product Health Insurance Program Quality care
Dose creep (CHIP) Reauthorization Act Quality control
Error of 2015 Regulation
1
2 CHAPTER 1 Introduction to Quality Management
Risk Safety System

Risk management Standard The Health Insurance Portability and
Safe Medical Devices Act Supplier Accountability Act (HIPAA)

Diagnostic imaging is a multistep process by which informa- 3. Actual quality. This level of quality uses statistical data
tion concerning patient anatomy and physiology is gathered to measure outcomes and considers all factors that can
and displayed with the use of modern technology. Unfortu- influence the final outcome (e.g., the quality of the image,
nately, numerous sources of variability, in both human fac- accuracy of diagnosis, timeliness of report to primary phy-
tors and equipment factors, can produce subquality images sician). It also can compare the quality of the product or
if not properly controlled. This can result in repeat exposures service with that of a competitor. This type of quality is most
that increase both patient dose and department cost and pos- useful in quality management programs because it allows
sibly decrease the accuracy of image interpretation. This in for data-driven decision making that can be used by man-
turn can result in decreased customer satisfaction (customers agement in order to revise or replace business processes and
being physicians, vendors, insurance companies, employees, other management decisions. The success of the data-driven
and patients) that ultimately costs the healthcare provider lost approach is reliant on the quality of the data gathered and
business and revenue. The purpose of a quality management the effectiveness of its analysis and interpretation.
program is to control or minimize these variables as much as In diagnostic imaging departments, we can ultimately
possible. In a diagnostic imaging department, these variables define quality as the extent to which the right procedure is
include equipment; image receptor system; quality of image done in the right way at the right time, and the correct inter-
processing; viewing or display conditions; and competency pretation is accurately and quickly communicated to the
of the technologist, support staff, and the observer or inter- patient and referring physician. Measuring and improving
preter. By reducing these variables, the quality of imaging quality is essential not only to ensure optimum effectiveness
services should increase, inefficiencies that increase the cost of care and comply with increasing regulatory requirements
of these services should decrease, and the satisfaction of the but also to combat current trends leading to commoditization
customer should increase. of radiology services.
In healthcare environments, quality care should be the Since the early 1980s, healthcare delivery in the United
main focus because it will lead to higher customer satisfac- States has undergone dramatic changes that have affected
tion and continued success for the healthcare organization. diagnostic imaging departments and their ability to provide
The National Academy of Medicine (NAM) defines qual- quality care. These changes include the following:
ity care as providing patients with appropriate service in a • Advances in technology, equipment, and procedures. The
technically competent manner, with good communication, digitization of radiography, along with expensive technol-
shared decision making, and cultural sensitivity. In diagnos- ogies such as magnetic resonance imaging (MRI), spiral
tic imaging departments, the quality of patient care and the computed tomography (CT), electron beam tomography,
diagnostic images that are produced is the main outcome. positron emission tomography (PET), digital radiography
When discussing the quality of particular goods or services, and fluoroscopy, and single-photon emission computed
one must keep in mind the three levels on which quality is tomography (SPECT), has increased the cost of equipment
determined: acquisition, installation, and maintenance.
1. Expected quality. This is the level of quality of the product • Legislation and government regulations. Legislation such
or service that is expected by the customer and may be as the Safe Medical Devices Act (SMDA) of 1990, the
influenced by outside factors such as prior word of mouth Mammography Quality Standards Act (MQSA) of 1992,
from friends and relatives. A diagnostic imaging profes- Mammography Quality Standards Reauthorization Act
sional would likely have the least amount of impact on (MQSRA) of 1998, and the Medicare Improvements
this level of quality because it is present before the patient for Patients and Providers Act of 2008 has increased the
comes into the imaging department. responsibility of diagnostic imaging department managers
2. Perceived quality. This is the customer’s perception of the and staff to document proper equipment operation and
product or service. It is based on the customer’s perception procedures. This is in addition to requirements from the
of the product or service and is highly subjective and more Occupational Safety and Health Administration (OSHA),
difficult to measure quantitatively. For patients under- the Environmental Protection Agency (EPA), and the
going diagnostic imaging, their experience (such as how Food and Drug Administration (FDA) that affect matters
long they had to wait or how they were treated) during ranging from blood-borne pathogens to disposal of pro-
the procedures greatly influences their perception of qual- cessing chemicals.
ity. Therefore how well an imaging professional performs • Accreditation Procedures. The accreditation procedures of
his or her respective responsibilities will have the greatest The Joint Commission (TJC) and others have gone from
impact on this level of quality. Because perceived quality the philosophy of quality assurance (QA) to one of total
is often what brings patients back to a hospital or imaging quality management (TQM) (explained in more detail
center, it can be more important than the actual quality. later in this chapter).
CHAPTER 1 Introduction to Quality Management 3
Corporate buyouts and mergers. In the United States over 30% this could be considerable because the result could lead to lost
of all hospitals that were open and functioning in 1980 business at the very least or the injury or death of a patient at
have closed, whereas a relatively few number of new hos- the very worst.
pitals have opened to replace them. Many others have been
purchased by “for profit” healthcare organizations or have STANDARDS, REGULATIONS, AND QUALITY
merged to condense costs or reduce competition, or both.
• Methods of reimbursement for services rendered. The previ- MANAGEMENT
ous method of “fee for service” reimbursement of health- A quality management program has to incorporate standards
care expenses is rapidly being replaced by managed care and regulations that must be met in order for the healthcare
plans such as health maintenance organizations (HMOs) organizations to remain in business. A standard is a statement
and point of service plans such as preferred provider orga- that is defined and promoted by a professional body or organi-
nizations (PPOs). The lower rate of reimbursement from zation, by which the quality of practice or service can be evalu-
these plans has reduced the operating budgets of many ated. Standards are to be viewed as the minimum, rather than
diagnostic imaging departments. In addition, many insur- the maximum, expectation of care. Standards are important
ers are now employing radiology benefits management because all healthcare professions have standards that guide
companies (RBMs) to determine the necessity of various practice. Healthcare organizations also establish standards that
diagnostic imaging orders. Federal legislation such as the apply to their staff and work processes within the organization.
Deficit Reduction Act of 2005, Medicare Improvements Accrediting agencies (such as TJC and DNV-GL, discussed
for Patients and Providers Act of 2008, and the Patient later in this chapter) have standards that must be applied to all
Protection and Affordable Care Act of 2010 (PPACA) all healthcare organizations in order to maintain accreditation.
attempt to cap reimbursements for medical examinations Accreditation is a method that is used to assess organizations
and procedures. The PPACA contains a provision whereby and determine whether they meet minimum established stan-
reimbursement will change from a “fee for service” to a dards. Technologists also must commit to their profession’s
“bundled payment.” This would result in a single payment scope of practice standards (such as those established by the
to a hospital or physician group for a defined episode American Society of Radiologic Technologists [ASRT] and
of care (such as a fractured hip) rather than individual the American Registry of Radiologic Technologists [ARRT]
payments for itemized fees and services. On December for imaging technologists) in order to meet certification and
18, 2015, President Obama signed into law Consolidated licensure requirements.
Appropriations Act of 2016, bipartisan legislation that pro- Standards that have been written into local, state, or federal
vided funding for the federal government for the 2016 fis- law that are employed in controlling, directing, or managing
cal year (October 1, 2015, to September 30, 2016). Within an activity, organization, or system are known as regulations.
this extensive legislation were radiology provisions related Regulations are usually enforced by a regulatory agency (such
to the reimbursement for analog radiography (film), com- as the Center for Devices and Radiologic Health [CDRH],
puted radiography (CR), and digital radiography (DR) which is a part of the Food and Drug Administration).
imaging services. The law is implemented by the Centers Quality management programs can ensure compliance with
for Medicare and Medicaid Services (CMS) and took effect standards and regulations as well as provide data for revision
on January 1, 2017. The rule follows the same framework or replacement of standards when they become obsolete or
that CMS used to implement the CT reimbursement when new technology is developed.
scheme codified in the Protecting Access to Medicare Act
of 2014 designed around NEMA XR 29. HISTORY OF QUALITY MANAGEMENT IN
Medicare reimbursements of the technical component under
the Physician Fee Schedule and the Hospital Outpatient
DIAGNOSTIC IMAGING
Prospective Payment System were reduced by 20% for radio- One of the earliest known methods of evaluating the qual-
logic examinations conducted using a film/screen system. ity of clinical healthcare by assessing patient outcomes was
On January 1, 2018, a reduction of 7% occured for images carried out by Florence Nightingale in the 1860s. She was
obtained with CR systems. one of the first to use a systematic approach to collecting and
These changes have made a quality management program analyzing mortality rates and other data in hospitals, and
essential to the operation and survival of a diagnostic imaging recommending changes based on these data. In 1910 Ernest
department. The cost of such a program in the form of per- Codman, MD (who helped found the American College of
sonnel time and test equipment is more than offset by the sav- Surgeons), proposed the “end result system of hospital stan-
ings from lower repeat rates, less equipment downtime, film dardization.” With this system, a hospital would track patients
and chemical savings in analog departments, greater depart- to determine whether the treatment given was effective. If the
ment efficiency, and increased customer satisfaction because treatment was not effective, the hospital would then attempt
waiting time can be reduced. When assessing the effective- to determine why, so that a more successful treatment could
ness of a quality management program, one must consider be used in future patients.
the cost of quality. This is defined as the expense of not doing The origins of modern quality management can be traced
things right the first time. In diagnostic imaging departments, back to the early 1900s, in the work of an industrial engineer
named Frederick Winslow Taylor. Taylor is considered the (a key component in quality management programs) a profes-
“Father of Scientific Management” because of his philosophy sional responsibility of all healthcare providers and person-
that the planning function and the execution stage of produc- nel as well as a quality of care issue rather than a managerial
tion be separate and that numerous individuals be assigned tactic.
specific tasks within the production process to minimize the
complexity of the task. With complexity minimized, the hope Governmental Action
was to maximize efficiency because, theoretically, fewer mis- The federal government’s first step toward requiring that diag-
takes would occur. Job tasks were broken down into simple, nostic imaging departments implement quality management
separate steps that could be performed over and over again programs came in 1968 with the Radiation Control for Health
(i.e., assembly lines). Only specific persons were assigned the and Safety Act (Public Law 90-602). This law required the U.S.
task of quality control (QC) inspection. This philosophy was Department of Health, Education, and Welfare (now called
common practice, both in American industry and in health- Health and Human Services) to develop and administer stan-
care settings (including diagnostic imaging), until the 1980s. dards that would reduce human exposure to radiation from
During the 1980s, the concept of quality improvement electronic products. The Bureau of Radiologic Health (BRH)
began to gradually replace the concept of scientific manage- (now called the National Center for Devices and Radiologic
ment. This concept is credited to W. Edwards Deming and Health) was given the responsibility for implementing this
Joseph Juran, who used the quality improvement philosophy act. The BRH set forth regulatory action, beginning in 1974,
to revitalize the economy of Japan after World War II. This with several amendments to control the manufacture and
concept combines quality control with an overall manage- installation of medical and dental diagnostic equipment to
ment philosophy that gives input to all persons involved in reduce the production of useless radiation. These regulations
the process of creating the specific good(s) or service(s). (This are contained in the document Title 21 of the Code of Federal
concept is discussed in further detail later in this chapter.) Regulations Part 1020 (21 CFR 1020). Title 21 refers to the
Many diagnostic imaging departments have been systemati- FDA. In 1978 the BRH published the “Recommendations
cally monitoring their equipment and procedures (i.e., quality for Quality Assurance Programs in Diagnostic Radiology
control) since the 1930s, independent of any government reg- Facilities.” Accrediting agencies, along with most state public
ulation or accreditation agency. The main motivations were to health agencies, have adopted these recommendations into
save money and increase efficiency and quality of care. Since their various policies governing diagnostic imaging depart-
then, governmental action and policies mandated by accredi- ments.
tation agencies have all but required that an extensive quality In 1981, the Consumer-Patient Radiation Health and Safety
management program be implemented by diagnostic imaging Act (Public Law 112-90) addressed issues such as unnecessary
departments. In 1992, the Accreditation Manual for Hospitals, repeat examinations, quality assurance techniques, referral
published by TJC, began a multiyear transition to standards criteria, radiation exposure, and unnecessary mass screening
that emphasize performance improvement concepts inspired programs. It also established minimum standards for accredi-
by the work of Deming and Juran. tation of educational programs in the radiologic sciences and
Beginning in the late 1990s, the National Academy of for the certification of radiographic equipment operators. This
Sciences–Institute of Medicine (IOM) began researching law motivated many states to enact licensure laws for radio-
how healthcare is delivered in the United States. In March logic technologists. However, there is no legal penalty for
2016, this group changed its name to National Academy of noncompliance contained within the law, and eight states,
Sciences–Health and Medicine Division (NAS/HMD). This plus the District of Columbia, currently have no minimum
nonprofit agency, based in Washington, DC, is not connected educational or certification criteria for healthcare workers
to the government but serves as an advisory group to the gov- who perform radiologic procedures. As of the writing of this
ernment, businesses, educators, and healthcare professionals. edition, the eight states are Alabama, Alaska, Georgia, Idaho,
This group published two key reports, the first of which was Missouri, North Carolina, Oklahoma, and South Dakota. The
To Err Is Human (1999), which recognized that there was states of Michigan and Nevada license mammographers but
a need to know more about the healthcare delivery system not radiographers, whereas Wisconsin does not license radiog-
and its quality. The second publication, Crossing the Quality raphers but does require American Registry of Radiologic
Chasm (2001), concluded that the U.S. healthcare delivery Technologists certification. In September 2000, the Consumer
system was dysfunctional, with great variety in performance, Assurance of Radiologic Excellence (CARE) Act was first
fragmented and poorly organized, confusing, and complex. introduced in Congress by Rep. Rick Lazio (R-NY) as H.R.
It also noted a need for systematic monitoring of healthcare 5624. In 2006, the CARE bill was retitled the Consistency,
quality in order to better improve care. This led to the cre- Accuracy, Responsibility and Excellence in Medical Imaging
ation of the National Healthcare Quality Report (NHQR), and Radiation Therapy Bill because many of the imaging
which is published annually by the Agency for Healthcare disciplines included in the CARE legislation are not directly
Research and Quality (AHRQ). The AHRQ is an agency in related to radiology. The CARE Act mandates educational and
the Department of Health and Human Services (HHS) and training requirements for all technologists performing imag-
distributes the NHRQ on its website (www.ahrq.gov). The ing procedures (thereby mandating the standards contained
conclusions of these publications made quality improvement in the Consumer-Patient Radiation Health and Safety Act of
1981). In addition to improving the quality of care nation- are designed to place a barrier between the patient with the
wide, enacting the CARE Act also would save considerable disease and everyone else. They are specifically geared toward
money each year. According to the Radiologic Society of North preventing infection by minimizing the three specific modes
America (RSNA) journal, Radiology, approximately 130 mil- of disease transmission: air, droplet, and contact. The com-
lion diagnostic radiology procedures are performed on 36 mil- plete OSHA policy on infection control blood-borne patho-
lion Medicare enrollees per year. Over $10 billion is spent by gens can be found in the Federal Register under Title 29 of the
Medicare on medical imaging procedures each year (according Code of Federal Regulations Part 1910 (29 CFR 1910). OSHA
to the Medicare Payment Advisory Commission [MedPAC]). also is responsible for monitoring the workplace environ-
If the national repeat examination rate is between 4% and 7% ment, including the requirements for occupational exposure
(averaging 5.5%) and the CARE bill can lower repeat rates from to radiation and to chemicals found in processing solutions.
5.5% to 4.5%, enacting education and credentialing standards OSHA also has proposed an ergonomics standard with the
could save Medicare over $100 million a year. As of the printing objective of reducing the rising incidence of work-related
of this text, the CARE Act has yet to be enacted. The CARE bill injury and workers’ compensation claims.
had to be reintroduced in the 113th Congress in March 2013 The Safe Medical Devices Act (SMDA) of 1990 (Public
(the eighth time it has been introduced in the House in the past Law 101-629) was enacted in order to increase the amount
13 years) as H.R. 1146. One week later, it was also introduced of information the FDA and device manufacturers receive
in the U.S. Senate as S. 642. As of the writing of this edition, about problems with medical devices. Under the act, medi-
this bill has not made it to a vote in either branch of congress. cal facilities must report to the FDA and the manufacturer, if
In July 2008, Congress passed the Medicare Improvements known, any medical devices (e.g., malfunctioning bed, non-
for Patients and Providers Act of 2008 (MIPPA), which man- working defibrillator, nonworking pacemaker, malfunction-
dates that any nonhospital institution performing advanced ing radiation therapy unit, or excessive radiation dose during
diagnostic services (such as nuclear medicine and PET) must a diagnostic procedures such as interventional fluoroscopy)
be accredited as of January 1, 2012, in order to receive federal that have caused the death or serious injury of a patient or
funding (Medicare reimbursement). Accreditation must be by employee. Facilities also must report device-related serious
one of three U.S. Centers for Medicare and Medicaid Services injuries to the device manufacturer or to the FDA if the man-
(CMS)–approved agencies. These are (1) American College of ufacturer is not known. In addition, the SMDA requires that
Radiology (ACR), (2) TJC, and (3) Intersocietal Accreditation device user facilities must submit to the FDA, on a semiannual
Commission (IAC). Basic areas of CMS requirements are (1) basis, a summary of all facility records submitted during that
personnel qualifications for nonphysician medical staff, med- period. It also authorizes civil penalties to healthcare workers
ical directors, and supervising physicians; (2) image quality or facilities that do not report defects and failures in medical
standards; (3) equipment performance standards; (4) safety devices. When any incidents of unsafe medical devices are
standards for staff and patients; and (5) quality assurance and reported to the FDA, Form 3500 should be used for voluntary
quality control standards. Should the CARE bill be adopted, reporting, and Form 3500 A should be used for mandatory
the same provisions would be in place for hospital-based reporting. Mandatory reporting requirements for user facil-
services. ities are shown in Table 1.1. A full listing of requirements of
In the mid-1980s, OSHA, in response to the outbreak of the SMDA can be found in the Code of Federal Regulations,
human immunodeficiency virus (HIV) and hepatitis B virus 21 CFR 803.
(HBV), amended the existing federal regulations concerning In 1992, the Mammography Quality Standards Act (MQSA)
infection control in the workplace and mandated a policy on or Public Law 102-539 mandated quality assurance programs
blood-borne pathogens. All workplaces had to implement for all facilities that want to perform mammographic proce-
these new regulations by the spring of 1992. This policy states dures to obtain FDA approval. Specific requirements were
that an exposure control plan must be in place for all indus- designed for dedicated equipment, physicians interpreting
tries in which workers may come in contact with blood and
other infectious materials. Included in this policy are stan-
dard precaution procedures (also known as Tier 1 procedures), TABLE 1.1 Radiography DRL’s and AD’s
education programs for employees, free hepatitis B immu- Examination DRL (mGy) AD (mGy)
nization for staff who might be exposed to blood or body
Adult PA chest (23 cm) with 0.15 0.11
substances, follow-up care to any staff member accidentally grid
exposed to blood or bodily fluids through needle sticks and so Pediatric PA chest (12.5 cm), 0.06 0.04
on, personal protective equipment supplied by the employer without grid
(including gloves, gowns, laboratory coats, face shields, eye Pediatric PA chest (12.5 cm), 0.12 0.07
protection, pocket masks, and ventilation devices), and dis- with grid
posal procedures. These infection control procedures also Adult AP Abdomen (22 cm) 3.4 2.4
must include transmission-based precautions (also known as Adult AP lumbosacral spine 4.2 2.8
Tier 2 or category-specific precautions) that are used in addi- (22 cm)
tion to Tier 1 or standard precautions. They are used when a AD, Achievable dose; AP, anteroposterior; DRL, diagnostic reference
specific communicable disease is suspected or confirmed and level; PA, posteroanterior.
the images, medical physicists, and technologists. Most of TABLE 1.2 Violations and Penalties for
these standards were formulated by or in conjunction with HIPAA
the ACR and were in use by many facilities before enactment
of the MQSA. This law became effective October 1, 1994. The All Such
MQSA was replaced by the Mammography Quality Standards Violation Violations of an
Category— Identical Provision
Reauthorization Act (MQSRA) of 1998, also known as Public
Section 1176 (a)(1) Each Violation in a Calendar Year
Law 105-248. As part of the new law, final FDA regulations
concerning mammographic procedures became effective (A) Did not know $100–$50,000 $1,500,000
(B) Reasonable $1000–$50,000 $1,500,000
April 28, 1999, replacing interim regulations that were used
cause
during the original law. The final regulations emphasize per- (C) (i) Willful $10,000–$50,000 $1,500,000
formance objectives rather than specify the behavior and neglect—
manner of compliance. More specific information on the corrected
MQSA and MQSRA can be found in Chapter 9. (C) (ii) Willful $50,000 $1,500,000
The Health Insurance Portability and Accountability Act neglect—not
(HIPAA) of 1996 (also known as the Kennedy-Kassebaum corrected
Act or Public Law 104-191) was enacted to simplify health-
care standards and save money for healthcare businesses by
encouraging electronic transactions, but it also required new amended HIPAA’s enforcement regulations by adding sev-
safeguards to protect patient security and confidentiality. eral categories of violations and established ranges of penalty
HIPAA established national standards for healthcare e-com- amounts for each category of violation. These regulations
merce that include the following: took effect on February 18, 2009, and include the following
1. Electronic patient record system security requirements categories of violations and their respective penalty amounts
(security standard): This created a new national standard available (Table 1.2):
for the administrative, technical, and physical safety of Further information can be found in the Federal Register/
protected health information (PHI). Vol. 74, No. 209/Friday, October 30, 2009/Rules and Regulations
2. Standard electronic formats for insurance transactions 56127, and complete HIPAA guidelines can be found in
such as enrollment, encounters, and claims (transaction the Federal Register under Title 45 of the Code of Federal
standard): This standard requires the implementation of Regulations Parts 160–164 (45 CFR 160–164).
a uniform set of codes and forms, such as the American This means that healthcare administrators must have poli-
National Standards Institute (ANSI) ASC X12N format cies and procedures including establishing a system of security
for electronic healthcare transactions or professional and and confidentiality, training all personnel in these policies, and
institutional claims. appointing a staff member to act as a security officer to mon-
3. Standard identifiers and codes for institutions, personnel, itor compliance with these policies. This is discussed later in
diagnoses, and treatments (national identifier standard): this chapter. The ARRA of 2009 also requires certain criteria
This created national numbers to identify employers (known as meaningful use rules) that health information tech-
(EIN), health plans (Payer ID), and healthcare providers nology departments must meet in order to receive payment for
(National Provider Identifiers or NPI). It also contains a services from the Centers for Medicare and Medicaid Services
set of codes that are used to encode all healthcare data. The (CMS). Because Picture Archiving and Communication
four categories of these codes are (1) diseases (ICD-9); (2) Systems (PACS) are a part of Electronic Health Records (EHR),
injuries (ICD-10); (3) actions taken to prevent, diagnose, these rules impact diagnostic imaging departments.
treat, or manage diseases (CPT-4); and (4) substances, The current CMS-EHR objectives and measures that eligi-
equipment, and supplies (HCPCS). ble hospitals must meet are:
4. Patient information, confidentiality, and privacy rules 1. Protect electronic protected health information (ePHI)
(privacy standard): This created a new national standard created or maintained by the certified electronic health
for privacy of protected health information. record technology (CEHRT) through the implementation
The Department of Health and Human Services first issued of appropriate technical capabilities.
proposed regulations for these standards in November 1999, 2. Use clinical decision support to improve performance on
with final rules approved in December 2000. The rules took high-priority health conditions.
effect on April 14, 2001, and all healthcare organizations had 3. Use computerized provider order entry (CPOE) for medi-
to comply with and implement them by April 14, 2005. All cation, laboratory, and radiology orders directly entered by
medical records and patient information, whether electronic, any licensed healthcare professional who can enter orders
on paper, or oral, are covered by these final rules. into the medical record per state, local, and professional
Failure to comply with these standards resulted in sig- guidelines.
nificant penalties ranging from as little as $10 to $250,000 4. Generate and transmit permissible discharge prescriptions
dollars and 10 years in prison. The American Recovery and electronically (eRx).
Reinvestment Act of 2009 included the Health Information 5. Health Information Exchange—The eligible hospital who
Technology for Economic and Clinical Health Act that transfers their patient to another setting of care or provider
of care or refers their patient to another provider of care that having more people insured will increase the demand for
provides a summary care record for each transition of care healthcare services, thereby increasing the demand for imag-
or referral. ing professionals in the workplace. Because many provisions
6. Use of clinically relevant information from the CEHRT to are scheduled to become effective gradually between 2014
identify patient-specific education resources and provide and 2020, it will take time to evaluate the impact of the law.
those resources to the patient. The Patient Protection and Affordable Care Act also intro-
7. The eligible hospital that receives a patient from another duced penalties for providers who do not submit qualifying
setting of care or provider of care or believes that an data to the Physician Quality Reporting System (PQRS). The
encounter is relevant performs medication reconciliation. PQRS system is a healthcare quality improvement incentive
8. Patient Electronic Access—Provides patients the ability to program initiated by the Centers for Medicare and Medicaid
view online, download, and transmit their health informa- Service (CMS). In 2015 the program began applying a nega-
tion within 36 hours of hospital discharge. tive payment adjustment to individual EPs and PQRS group
9. Public Health Reporting—The eligible hospital is in active practices who did not satisfactorily report data on quality
engagement with a public health agency to submit elec- measures for Medicare Part B Physician Fee Schedule (PFS)
tronic health data from the CEHRT except where prohib- covered professional services in 2013. Those who report sat-
ited and in accordance with appropriate law and practice. isfactorily for a program year will avoid the PQRS negative
Hospitals must apply these criteria to their health informa- payment adjustment 2 years later.
tion technology departments and connect them to their qual- The election of Donald Trump as president in 2016, along
ity improvement programs. with a Republican majority in both houses of Congress, has
The Deficit Reduction Act of 2005 (DRA), also known pledged to appeal the PPACA. As of the writing of this edi-
as Public Law 109-362, was enacted to help make $11 bil- tion, a replacement has yet to be enacted.
lion in cuts from 2007 (when the DRA went into effect) to To ensure Medicare physician reimbursement rates (and
2015 in Medicare and Medicaid programs. One aspect of the therefore Medicare patient’s access to their physicians), the
program is to reduce payments for freestanding diagnostic Protecting Access to Medicare Act of 2014 or Public Law
imaging centers by capping some current procedural termi- 113-93 (also known as the sustainable growth rate or SGR
nology (CPT) codes that were higher than hospital outpatient patch) was enacted. Some of the provisions in this law that
rates and freezing CPT codes already lower than hospital effects diagnostic imaging departments include requiring
outpatient rates. Current procedural terminology codes were ordering physicians of advanced imaging procedures to pro-
developed by the American Medical Association (AMA) and vide support using appropriate use criteria; improved and
adopted by the federal government and private insurance stricter patient radiation dose safety controls and levels (such
providers to classify medical, surgical, and diagnostic ser- as CT dose index and dose length product); and that all CT
vices. The DRA also requires imaging centers to have quality equipment must meet NEMA standards.
control standards in place in order to receive reimbursement. In April 2015, the Medicare Access and Children’s Health
Having an effective quality management program also Insurance Program (CHIP) Reauthorization Act of 2015
has become necessary as a condition of receiving reim- (MACRA), or Public Law 114-10, was enacted to modify the
bursement for services by the federal government. The U.S. Protecting Access to Medicare Act of 2014.
Department of Health and Human Services, through its • The law repeals the sustainable growth rate (SGR) meth-
subbranch, the Centers for Medicare and Medicaid Services odology for determining updates to the Medicare physi-
(CMS), emphasizes effective quality management procedures cian fee schedule.
be documented in order for healthcare facilities to receive • It establishes annual positive or flat fee updates for 10 years
reimbursement for any healthcare service, and many private and institutes a two-track fee update beginning in 2019.
insurance companies have followed this practice. • It establishes the Merit-based Incentive Payment System
The Patient Protection and Affordable Care Act of 2010, (MIPS) that consolidates existing Medicare quality pro-
commonly known as “Obama Care” or Public Law 111- grams.
148, was enacted to increase health insurance coverage for • It establishes a pathway for physicians to participate in an
Americans as well as reducing the overall cost of healthcare. Alternative Payment Model (APM).
There are far too many provisions of this bill to cover in a This law focuses on quality (both a set of evidence-based,
chapter of a book, and so I will mention only the ones that specialty-specific standards as well as practice-based improve-
should have a direct impact on diagnostic imaging department activities); cost; and use of Certified Electronic Health
ments. One provision (discussed earlier in this chapter) Record Technology (CEHRT) to support interoperability and
would change Medicare reimbursement from “fee for service” advanced quality objectives in a single, cohesive program that
to a bundled payment for a “defined episode of care,” which avoids redundancies.
could lower the reimbursement rate to healthcare provid- In December 2016, Congress passed the Consolidated
ers. Another provision adds a 2.3% excise tax on all medical Appropriations Act of 2016, or Public Law 114-113 (also
devices (such as diagnostic imaging equipment) that is col- known as the 2016 omnibus spending bill). This bill provided
lected at the time of purchase. This could lead to more equip- funding to the federal government through September 30,
ment being leased rather than purchased. It is also thought 2016. The most important aspect of this bill for diagnostic
imaging departments was the incentives for healthcare insti- governance, and support activities. TJC standards also
tutions to convert to digital radiography (DR). The act accom- require that healthcare organizations must perform routine
plished this by reducing reimbursement for plain film x-rays inspections of all equipment, devices, and supplies.
by “20% in 2017 and all subsequent years,” and also reducing Before 1991, TJC used the concepts of quality assurance
computed radiography reimbursement by 7% from 2018 to and quality control requiring systematic monitoring and
2022 and 10% thereafter. evaluation, with the responsibility left to the medical director
or department head. Because these concepts now have been
The Joint Commission incorporated into the newer quality management philosophy,
TJC, formerly known as the Joint Commission for the an understanding of quality assurance and quality control is
Accreditation of Healthcare Organizations, or JCAHO), was still important and is discussed in the following sections.
founded in 1951 and is an independent, not-for-profit orga-
nization that accredits and certifies more than 20,000 health- Det Norske Veritas Healthcare
care organizations and programs in the United States. In the DNV Healthcare, Inc., is part of Det Norske Veritas, a global
1970s, TJC began requiring hospitals and other healthcare foundation that was established in Oslo, Norway, in 1864 and
providers to perform and document specific quality assur- has been operating in the United States since 1898. Their stated
ance procedures in order for these facilities to obtain accred- purpose is to safeguard life, property, and the environment. On
itation. Accreditation is voluntary, but hospitals and medical September 26, 2008, DNV Healthcare was granted authority to
centers that do not have it may not possess Medicaid certi- accredit hospitals by the CMS, and is therefore an alternative
fication, hold certain licenses, have a residency program for to TJC for hospitals to receive accreditation. DNV Healthcare
training physicians, obtain reimbursements from insurance merged with Germanischer Lloyd, a nonprofit association
companies, or receive malpractice insurance. However, some based in Hamburg, Germany, to become DNV-GL. The newly
hospitals may choose not to be accredited by TJC and instead formed DNV-GL Group became operational on September
have inspections by their state public health departments or 12, 2013. DNV-GL accreditation standards combines the
other organizations such as DNV-GL Healthcare (discussed standards created by the National Integrated Accreditation
later in this chapter). These hospitals include many rural for Healthcare Organizations (NIAHO) with those created
hospitals that may be critical access hospitals and would by the International Organization for Standardization (ISO)
still receive Medicaid and Medicare reimbursements. TJC based in Geneva, Switzerland (www.iso.org). These standards
accredits not only hospitals but also facilities for long-term are based on very similar quality management principles as
care, ambulatory care, mental health, and chemical depen- TJC standards, namely:
dency. TJC standards are based on the Medicare Conditions 1. Customer focus
of Participation (CoPs) that must be met in order for insti- 2. Leadership
tutions to receive Medicare and Medicaid reimbursement. 3. Involvement of people
TJC puts the CoPs in context for hospital leaders through 4. Process approach
a larger set of standards that define how high-quality/safe 5. System approach to management
patient care should be delivered. The standards have evolved 6. Continual improvement
over time through the work of healthcare leaders and subject 7. Factual approach to decision making
matter experts, along with input from accredited organiza- 8. Mutually beneficial supplier relationships
tions. There are also leadership standards that focus on align- DNV-GL accreditation requires that institutions achieve ISO
ing the organization around a set of improvement priorities. 9001 certification, or at least ISO 9001 compliance within the
TJC standards also mandate a quality management system be first 3 years. Within the ISO 9001 standards is a major focus
in place as well as consistent process execution. TJC quality on alignment with strategy, a clear and effective quality man-
management procedures are extensive and specific in nature. agement system, and consistent process execution. DNV-GL
For example, any equipment that is inspected daily (Monday accreditation does not supplement the CoPs with any addi-
through Friday) also must be inspected on Saturday and tional patient care standards or patient safety goals that TJC
Sunday if the opportunity exists that a patient would need requires. How care is provided is left up to the individual
that piece of equipment on the weekend. Second, refrigera- healthcare organization and the framework for deciding
tors that contain medical supplies must have a thermometer, which processes to focus on, how to design/improve them,
and a log of the daily recorded temperature (including week- and how to manage their performance lies within the ISO
ends) must be kept. TJC also requires accredited institutions 9001 requirements. The healthcare organization must learn
to have a process in place for correcting customer complaints and be in compliance with these requirements by their third
(a process known as service recovery). This means that proper year of accreditation under DNV-GL.
performance and documentation of quality management
procedures are essential to pass TJC inspections. Standards Quality Assurance
set by TJC to receive accreditation require that healthcare Quality assurance (QA) is an all-encompassing management
organizations have a planned, systematic, and organiza- program used to ensure excellence in healthcare through the
tion-wide approach for monitoring, evaluating, and improv- systematic collection and evaluation of data. The primary
ing the quality of care, as well as those of management, objective of a QA program is the enhancement of patient care;
this includes patient selection parameters and scheduling, Routine performance evaluations are specific tests per-
management techniques, departmental policies and proce- formed on the equipment in use after a certain amount
dures, technical effectiveness and efficiency, in-service edu- of time has elapsed. These evaluations can verify
cation, and image interpretation with timeliness of reports. that the equipment is performing within previously
The main emphasis of the program is on the human factors accepted standards and can be used to diagnose any
that can lead to variations in quality care. Quality assurance changes in performance before becoming radiograph-
should not be confused with quality assessment, which is the ically apparent.
measurement of the level of quality at some point in time with Error correction tests evaluate equipment that is malfunc-
no effort to change or improve the level of care. tioning or not performing at the manufacturer’s speci-
fications and are also used to verify the correct cause of
Quality Control the malfunction so that the proper repair can be made.
Quality control (QC) is the part of the QA program that
deals with techniques used in monitoring and maintaining Continuous Quality Improvement
the technical elements of the systems that affect the quality The older QA/QC program ensured that a certain level of
of the image. Therefore quality control is the part of the QA quality was met; it required monitoring only periodically for
program that deals with instrumentation and equipment. A maintenance. It was segmented in approach because each
quality control program includes the following three levels of department in a facility monitored and evaluated its own
testing: structural outcomes, creating a tendency to view individual
Level I: Noninvasive and Simple. Noninvasive and simple performances rather than the process or system in which that
evaluations can be performed by any technologist and individual was functioning. In turn, the program was exter-
include tests such as the wire mesh test for screen contact nally motivated because its emphasis was on demonstrating
and the spinning top test for timer accuracy. compliance with externally developed standards. As long
Level II: Noninvasive and Complex. Noninvasive and com- as the standards were met, no further work was required to
plex evaluations should be performed by a technologist improve the system.
who has been specifically trained in quality control pro- In 1991, TJC began incorporating the concepts of con-
cedures. This is because more sophisticated equipment, tinuous quality improvement (CQI), which is defined as a
such as special test tools, meters, or the noninvasive eval- structured organizational process for involving personnel in
uation of radiation output (NERO) computerized mul- planning and executing a continuous flow of improvements
tiple function unit, is used. Many educational programs to provide quality healthcare that meets or exceeds expec-
now include this level of competency for graduation, tations, to replace the older QA/QC philosophy into their
and so the number of technologists with these skills is program of accreditation of healthcare organizations. CQI
increasing. The American Society of Radiologic Technol- evolved from total quality management (TQM) concept in
ogists (ASRT) includes quality control and QA duties in the manufacturing industry, also referred to as total quality
its practice standards for radiographers, sonographers, control (TQC), total quality leadership (TQL), total quality
nuclear medicine technologists, CT technologists, MRI improvement (TQI), and statistical quality control (SQC). This
technologists, mammographers, interventional radiogra- concept is based on the “14 Points for Management” devel-
phers, and bone densitometry technologists. The Amer- oped by W. Edwards Deming (Box 1.1) and the Japanese
ican Registry of Radiologic Technologists (ARRT) offers management style.
an advanced-level certification examination for tech- The CQI concept does not replace the concept of QA/QC
nologists wishing to document their knowledge of QA but incorporates it at a higher conceptual level. Instead of just
and quality control procedures and protocols. This can ensuring and maintaining quality, it continually improves
be used to verify qualification for a quality management quality by focusing on improving the system or process in
technologist position. which individual workers function rather than on the indi-
Level III: Invasive and Complex. Invasive and complex eval- viduals themselves. For these processes to improve, it is essen-
uations involve some disassembly of the equipment and tial to focus on the organization as a whole rather than on
are normally performed by engineers or physicists. This individual departments. It is important that each healthcare
book focuses on levels I and II of quality control testing. organization has a clear mission, values, and objectives that
The following are the three types of quality control tests on
various levels:
BOX 1.1 Administrative Procedures
Acceptance testing is performed on new equipment or
equipment that has undergone major repair to demon- Establish thresholds of acceptability.
strate that it is performing within the manufacturer’s Establish an effective communication network.
specifications and criteria. It also can detect any defects Provide for patient comfort.
that may exist in the equipment. The results obtained Ensure accepted performance of diagnostic imaging person-
nel.
during acceptance testing are also used to establish the
Develop a record-keeping system.
baseline performance of the equipment that is used as a Establish corrective action procedures.
reference point in future quality control testing.
performance improvement processes are designed and imple- • A supplier is an individual or entity that furnishes input to
mented to support. It also promotes the need for objective a process (e.g., person, department, organization) or one
data involving statistics to analyze and improve processes who provides the institution with goods or services. For
(known as data-driven or evidence-based analysis). Every diagnostic imaging departments, examples may include
employee should be actively involved in CQI (rather than imaging equipment vendors and referring physicians. An
just management or the quality control technologist) for the organization and its suppliers are interdependent, and a
program to be successful. In this way, CQI can be internally mutually beneficial relationship enhances the ability of
motivating because employees will see that their involvement both to create value for both parties.
is tied to the success of the hospital, creating an atmosphere in • Input is information or knowledge necessary to achieve
which employees are motivated to do better because they are the desired outcome or everything that is used (mostly
participating actively. Management must take the responsibil- as variables) to produce one or more outputs from a pro-
ity to promote this atmosphere, effectively allocate resources cess. For diagnostic imaging departments, examples may
needed for improvement, treat employees as assets and not include patient information, examination requested, tech-
expenses, and work together toward shared goals. Managers/ nologist’s knowledge of procedures, and workload.
leaders should establish unity of purpose and direction of the • Action is the means or activity used to achieve the desired
organization. They should create and maintain the internal outcome or the steps or activities carried out to convert
environment in which people can become fully involved in inputs to one or more outputs. Examples for diagnostic
achieving the organization’s objectives. For healthcare institu- imaging departments may include computer entry and
tions, this should allow the ultimate focus to be on improving form completion and assignment of patients to appropri-
patient care, which should build a satisfied customer base and ate rooms. The action steps are sometimes referred to as
benefit the institution in the long-term. the workflow. A more technical definition of workflow is
the sequence of physical and mental tasks performed by
PROCESS IMPROVEMENT THROUGH various people within and between work environments.
These first three steps are variable factors that influence the
CONTINUOUS QUALITY IMPROVEMENT next portion of the process called the output.
As mentioned earlier, CQI focuses on the process in which • Output refers to the desired outcome, result, product, or
employees operate rather than on the employees themselves. characteristics that satisfy the customer or one or more
The rationale is that problems and variability with the process outcomes or physical products emerging from a process.
are the main cause of poor quality. The concept of process In diagnostic imaging departments, examples may include
improvement through CQI is based on the following premises: completed paperwork, completed diagnostic examination,
• 85/15 Rule—the process or system in place is the cause of and accurate radiologist report. A desired result is achieved
problems 85% of the time, and the people or personnel more efficiently when activities and related resources are
within the process are the cause of problems 15% of the managed as a process.
time. • Customer refers to a person, department, or organization
• 80/20 Rule—80% of the problems are the result of 20% of that needs, uses, or wants the desired outcome or a process.
the causes. According to Deming, the customer determines what con-
• Workers who are closest to the problem probably know stitutes quality. This can be broken down into the following
what is wrong with the process and are better able to fix it. groups:
• Structured problem-solving processes that use statistical • Internal customers: In general, these are individuals or
means to verify performance produce better long-term groups from within the organization such as referring phy-
solutions than processes that are not structured. sicians, hospital employees, departments, and department
• Improving quality is the responsibility of everyone within employees.
an organization because all are a part of the process. Peo- • External customers: These are individuals or groups from
ple at all levels are the essence of an organization, and their outside the organization, such as patients and their fami-
involvement enables their abilities to be used for the orga- lies, third-party payers, and the community.
nization’s benefit. The satisfaction of the customer, both internal and exter-
For healthcare organizations, most of the processes should nal, is the driving force behind CQI because it focuses on
be oriented toward the deliverance of high-quality care and the needs and expectations of customers and the continu-
the achievement of customer satisfaction. A process is an ous improvement of the product or service. By continually
ordered series of steps that help achieve a desired outcome meeting or exceeding customer satisfaction, the process is
or all the tasks directed at accomplishing one particular out- considered to be successful. Both customer satisfaction and
come grouped in a sequence. A system is a group of related health outcomes should be used as performance measures
processes. Identifying, understanding, and managing inter- to evaluate the success of a process in a healthcare environ-
related processes contribute to the healthcare organization’s ment. Organizations depend on their customers and there-
effectiveness and efficiency in achieving its objectives. The fore should understand current and future customer needs,
parts of any process include a supplier, input, action, output, meet customer requirements, and strive to exceed customer
and the customer. expectations.
Improvement projects can be taken up on output or input Protocol selection Standardized protocol:
metrics whenever a performance issue is found and varia- best practice
tions are seen in the process. The improvement efforts should Patient examination Environment of care,
be directed not only internally to improve process capabili- safety, and comfort;
ties but also externally to the suppliers who provide critical protocol complications
inputs. The organization can now establish clear control plans Interpretation (peer- Correct subspecialty
for managing the suppliers, inputs, and processes effectively reviewed credentials) interpretation, accuracy,
to ensure control over the outputs and to satisfy the custom- structured report,
report answers clinical
ers. These plans will typically include actions to be taken, the
question
frequency of the actions, responsibility, status check, and gov-
Finalization errors Timelines, succinctness
ernance on the entire plan by the quality and internal audit Communication of final Referring physician satis-
functions. A comprehensive control plan should include at report faction, query answered
least the following: or addressed
• Data collection trackers such as patient waiting time and Measuring and monitor- Turnaround time in exam-
repeat analysis ing performance inations and reporting,
• Control charts or other information display tools (cov- improvement in patient complications,
ered in the next chapter) for display and analysis of critical quality, safety, and and patient satisfaction
metrics efficiency
• Action plan trackers with responsibility and timelines to
address out-of-control situations Key Process Variables
• Review mechanism (internal with management and exter- Key process variables are the components of any process that
nal with customer) may affect the final output of the process. Variability can have
a negative impact on the quality of the final output, and sys-
Key Quality Characteristics tems must be developed to properly manage any variability
Key quality characteristics are those qualities or aspects that that may arise. Unfortunately, patients, providers, and diag-
have been identified as being most important to the customer, nostic categories found in healthcare are highly variable.
and are sometimes referred to as healthcare metrics. These There are five major categories of key process variables: man-
characteristics must be constantly measured and improved in power, machines, materials, environment, and policies.
order for customer satisfaction to increase. At an organiza- • Manpower refers to the personnel involved in the process.
tional level, healthcare metrics can be classified into the fol- • Machines refers to the equipment used in the process.
lowing basic types: • Materials refers to the type and quality of materials used
• Financial—track the financial performance of the health- in the process.
care system from a business perspective (usually standard • Environment refers to the physical and psychological
financial/accounting data) aspects on people involved in the process.
• Utilization—characterize the number and type of basic • Policies refers to the steps in the procedure or policy man-
services rendered, the resources that are used, and the ual that have been used in the process.
availability of care (e.g., MRI, PET) Key process variables can be divided into two groups—key
• Cost/Productivity—used to reduce supply/labor costs and input variables (KIVs) and key output variables (KOVs).
increase productivity KIVs are process inputs that have a significant impact on the
• Clinical Performance—also known as patient outcome variation found in a key process output variable and are the
data, these measure the quality of patient care, such as most important input(s) to a process. That is, if the key process
mortality rates and accuracy of diagnosis input variables were controlled (e.g., held constant), the process
• Patient Safety—metrics that characterize preventable would produce predictable and consistent outputs. KIVs are the
medical mistakes that are made components of a process that we can directly control to deliver
• Patient Satisfaction—measure satisfaction from a patient’s a quality product or service. KIVs are quick glimpses of the only
perspective real process controls at our disposal. Examples would include
In diagnostic imaging departments, the important metrics entry of the correct examination requested by the ordering
can be found in the imaging process sequence listed in the physician, or the proper patient identification before they are
following table: brought into the examination room. KOVs are measurable on,
within, or about the product or service itself and are the attri-
Event Metrics
butes seen by the customer. They are the process outputs that are
Referring physician Appropriateness guide-
affected by KIVs and are known collectively as quality. The qual-
orders examination lines, intended exam-
ination (ordering error) ity of the diagnostic image and the accuracy of the radiologists
Appointment scheduled Access time report would be examples of KOVs. In short, they are character-
Initial imaging depart- Patient wait time, patient istics that have a big impact on efficiency and/or customer satis-
ment encounter education (preparation) faction. Variation in key process output variables leads to lower
levels of quality and reliability and, ultimately, higher costs.
COMPONENTS OF A QUALITY MANAGEMENT 3. Risk management. The ability to identify potential risks to
patients, employees, and visitors at the healthcare institu-
PROGRAM IN DIAGNOSTIC IMAGING tion and establish processes that would minimize these
A comprehensive quality management program consists of risks is extremely important to healthcare organizations.
many different components, depending on the size and com- Civil litigation and workers’ compensation judgments can
plexity of the healthcare organization. Programs for diag- severely deplete the financial resources of even the largest
nostic imaging departments, regardless of the size, should healthcare organization.
contain at least the following components: 4. Radiation safety program. This is to ensure that patient
1. Equipment quality control. This aspect of a quality man- exposure is kept as low as reasonably achievable (ALARA)
agement program involves evaluation of equipment per- and that department personnel, medical staff, and members
formance to ensure proper image quality, as well as patient of the general public are protected from overexposure to
and operator safety. These procedures are covered exten- ionizing radiation.
sively in Chapters 4 through 13.
2. Administrative responsibilities. This aspect of the quality
management program involves the establishment of vari-
ADMINISTRATIVE RESPONSIBILITIES
ous processes to accomplish the specific departmental tasks Earlier in this chapter a distinction between quality assur-
that are required, such as departmental procedure manu- ance (which deals with human factors) and quality control
als for performing diagnostic examinations or procedures (which deals with equipment factors) is made. Merging these
for scheduling and routing of patients. It also involves data entities in a TQM program requires certain administrative
collection and analysis to continuously improve these pro- procedures (Box 1.1) to be implemented by radiologists,
cesses. Other responsibilities include cost control, manage- department administrators, quality control technologists
ment of personnel, education of personnel (education for (Box 1.2), quality improvement committees, and imag-
newly hired personnel and continuing education for existing ing professionals (because they have direct patient contact
workers), equipment acquisition, communication with vari- and are therefore on the front line in demonstrating qual-
ous vendors, communication with other departments within ity of care). Some of the more important administrative
the healthcare organization, and various other activities. procedures follow.
BOX 1.2 Quality Management Technologist Duties

Data from American Society of Radiologic Technologists: Prac- The scope of practice of the quality management technologist
tice standards for medical imaging and radiation therapy, Albu- also includes:
querque, 2016, ASRT. 1. Coordinating, performing, and monitoring quality control
The scope of practice of the medical imaging and radiation ther- procedures for all types of equipment
apy professional includes: 2. Determining and monitoring exposure factors and/or pro-
• Providing optimal patient care cedural protocols in accordance with ALARA principles and
• Receiving, relaying, and documenting verbal, written, and age-specific considerations
electronic orders in the patient’s medical record 3. Ensuring adherence to federal, state, and local regulatory
• Corroborating a patient’s clinical history with procedure and requirements
ensuring that information is documented and available for 4. Ensuring adherence to accreditation requirements
use by a licensed independent practitioner 5. Providing input for equipment and software purchase and
• Verifying informed consent for applicable procedures supply decisions when appropriate or requested
• Assuming responsibility for patient needs during procedures 6. Facilitating performance improvement processes
• Preparing patients for procedures 7. Providing practical information regarding quality manage-
• Applying principles of ALARA to minimize exposure to ment topics
patient, self, and others 8. Facilitating the department’s quality assessment and im-
• Performing venipuncture as prescribed by a licensed inde- provement plan
pendent practitioner 9. Facilitating change through appropriate management pro-
• Starting, maintaining, and/or removing intravenous access as cesses
prescribed by a licensed independent practitioner 10. Performing physics surveys independently on general ra-
• Identifying, preparing, and/or administering medications as diographic and fluoroscopic equipment (medical physicist
prescribed by a licensed independent practitioner oversight is required)
• Evaluating images for technical quality and ensuring that 11. Supporting and assisting a medical physicist with modality
proper identification is recorded physics surveys
• Identifying and responding to emergency situations 12. Providing assistance to staff for image optimization, includ-
• Providing education ing patient positioning, proper equipment use, and image
• Educating and monitoring students and other healthcare pro- critique
viders 13. Creating policies and procedures to meet regulatory, ac-
• Performing ongoing quality assurance activities creditation, and fiscal requirements
• Applying the principles of patient safety during all aspects of 14. Serving as a resource regarding regulatory, accreditation,
patient care and fiscal requirements
Threshold of Acceptability Payment System must survey recently discharged patients

The threshold of acceptability includes levels of accuracy, on their hospital experience using the Hospital Care Quality
sensitivity, and specificity of diagnosis (see Chapter 2). It also Information from the Consumer Perspective (HCAHPS) sur-
should include such items as the number of radiographs per vey. This survey was developed by the Centers for Medicare
examination, the amount of radiation per examination, and and Medicaid Services and the AHRQ in 2002. The core of
the performance thresholds of the equipment. These should the survey consists of 21 items that ask whether patients expe-
be established according to both external factors (such as fed- rienced a critical aspect of hospital care, rather than whether
eral and state guidelines or professional and accrediting agen- they were “satisfied” with their care. Also included in the
cies) and internal factors, which are based on the needs and survey are four screener items that direct patients to relevant
resources of the individual department. questions, five items to adjust for the mix of patients across
hospitals, and two items that support congressionally man-
Communication Network dated reports. Hospitals may include additional questions
Proper communication among all members of a diagnos- after the core HCAHPS items. Further information can be
tic imaging department is essential for a successful quality found at www.hcahpsonline.org.
management program. Items such as the proper examina-
tion ordered for a particular patient must be supplied to the Personnel Performance
technologist from the ordering physician and office support Policies should be developed to ensure that diagnostic per-
staff. The technologist also must communicate the appro- sonnel are performing their duties within accepted pro-
priate patient history to the radiologist and ensure proper fessional standards for areas such as proper equipment
film identification and marking. Administrative personnel operation, critical thinking, and interaction with patients and
and radiologists must then communicate with technologists other personnel. Information obtained from repeat analysis
about proper procedures and guidelines for patient care and studies and patient surveys can be useful in assessing perfor-
image parameters. Diagnostic imaging departments also mance. Documentation of data, periodic review of these data,
should have proper communication with other departments and any corrective actions that have been taken also should
within the healthcare setting such as the emergency depart- be included. Personnel education programs also should be
ment staff or floor nurses so that the patient can be cared offered and documented to improve performance and main-
for properly. Proper communication also includes report tain staff competency. In addition to continuing education in
dictation, transcription, and distribution to the ordering topics that are specific to each modality (i.e., new equipment
physician and other interested parties. Modern imaging operation, radiation safety, etc.), departments should also
departments rely on electronic reporting and electronic try to educate their personnel in quality management topics
record keeping (i.e., Hospital Information Systems and such as working in interdisciplinary teams, applying quality
Radiology Information Systems), and so a major admin- improvement activities, and using informatics.
istrative responsibility is ensuring that all personnel have
competency in computer usage and knowledge of HIPAA Record-Keeping System
requirements. A record-keeping system is necessary to document that quality
management and quality control procedures are being imple-
Patient Comfort mented and that they are in compliance with accepted norms.
Patient comfort, convenience, and privacy should be provided Items that should be included are processor control charts
within reasonable limits in diagnostic imaging departments. (film/screen departments only), phantom image results, equip-
Factors such as patient scheduling, preparation, waiting time, ment checklists, examination requisitions, equipment service
ambient room temperature, and politeness and consider- records, incident reports, personnel dosimetry reports of radi-
ation of personnel should be monitored regularly. This is best ation exposure, and image interpretation reports.
accomplished by a patient survey or questionnaire, which
should be sent to patients 3 to 7 days after the procedure for Corrective Action
maximum reliability. These can be administered in various If equipment or personnel are not performing to accepted
formats, including comment cards, mail surveys, web-based standards, corrective action must be taken and documented.
or social network surveys (using tools such as SurveyMonkey), Equipment downtime and failure should be documented
or telephone interviews (personal interviews with patients via using established forms and procedures. In-service education
telephone by trained interviewers). Some healthcare organi- or other corrective action procedures may be necessary for
zations may also use point-of-service interviews, which are department personnel. A flowchart is a useful tool in demon-
either self-administered or interviewer-administered ques- strating corrective actions for possible problems.
tionnaires that are usually completed after service delivery at
the clinical site. The method of delivery of patient satisfaction
surveys is usually determined by which method will yield the
RISK MANAGEMENT
greatest response rate. As discussed in Chapter 2, respect and An important aspect of a quality management program for
caring and timeliness of care are key clinical performance diagnostic imaging departments is risk management. This
indicators that require measurement by accrediting agen- is the system or process for the identification, analysis, and
cies. Acute care hospitals subject to the Inpatient Prospective evaluation of risks and the selection of the most advantageous
method for minimizing them. Other names for risk manage- healthcare institutions on their websites. Documentation
ment include safety and loss prevention, total loss control, or of adherence to these guidelines is essential in obtaining
loss control management. Risk can be defined as the chance of and maintaining accreditation.
an event or incident happening that may threaten or damage • Risks to employees and medical staff. Risks to employees
an organization. Measuring risk can take place in the form and professional staff include injuries from falls, back
of either the likelihood of something happening or the con- injury from lifting patients or heavy equipment, repet-
sequences should something actually happen. The purpose itive stress injuries, needle sticks, exposure to infectious
of a risk management program is to maintain quality patient diseases, exposure to ionizing radiation, and exposure
care and a safe environment for employees and visitors, while to toxic chemicals such as processing solutions. Most of
conserving the healthcare institution’s financial resources. the risks to employees and medical staff (like those to the
When studying risk management, it is important to note two patient) also can be reduced by implementing appropriate
important terms, safety and error. Safety is defined as the policies and procedures. Information to better ensure safe
freedom from accidental injury or death, and is a key dimen- labor practices and workplace safety is available from two
sion of healthcare quality. Error is defined as the failure of a federal agencies, namely the National Institute for Occu-
planned action to be completed as intended or the use of a pational Safety and Health (NIOSH) and the Occupational
wrong plan to achieve an outcome. Preventing errors in the Safety and Health Administration (OSHA). NIOSH is a
first place or resolving errors that do occur is a key objec- part of the Health and Human Services Center for Disease
tive of a risk management program. In quality management, Control and Prevention (CDC). Their goals are to (1) con-
blaming individual staff for errors rather than the processes duct research to reduce worker illness and injury and to
and system in place should be avoided. Therefore processes advance worker well-being; (2) promote safe and healthy
need to be in place to reduce the likelihood of an event occur- workers through intervention, recommendations, and
ring (risk reduction) and to minimize the consequences of capacity building; and (3) enhance international worker
an event, should one occur. The overall responsibility for risk safety and health through global collaborations. OSHA is
management may lie with a risk management coordinator, a a part of the U.S. Department of Labor. The function of
risk management team, the individual department manager, this agency is to assure safe and healthful working con-
or the department quality management person, depending on ditions for employees by setting and enforcing standards
the size and structure of the institution. However, all employ- and by providing, training, outreach, education, and assis-
ees must be made aware of their role in the risk management tance. Information concerning work-related employee
process. This includes proper education in both departmental injuries and illness is available in the Occupational and
and institutional policies and procedures, awareness of safety Safety Health Administration (OSHA) 2000 Log. This
issues, and the immediate reporting of incidents and hazard- report must be posted at the work site each year during
ous conditions to the appropriate person. the month of February. These reports may be maintained
by the human resources department, risk manager, or
Risk Analysis employee health department, depending on the insti-
The first step in developing risk management policies and tution. Potential workplace concerns for employees in
procedures for diagnostic imaging departments is to perform diagnostic imaging departments may include infections,
a risk analysis. This means identifying the potential risks to bloodborne pathogen exposure, injuries from lifting or
patients, employees, students, and visitors to the diagnostic moving patients, radiation exposure, chemical exposure,
imaging department. and magnetic field dangers for MRI technologists. Good
• Risks to patients. The potential risks to patients in diag- policies and procedures in place, along with proper train-
nostic imaging departments are considerable. For exam- ing and supervision, should reduce the likelihood of these
ple, patients may slip and fall, be hit by equipment, have a dangers.
reaction to contrast media, have entered the department • Risk to others. This category includes such persons as stu-
with a traumatic injury and be improperly manipulated, or dents, visitors, and volunteers and is probably the most
receive the wrong diagnostic procedure (all are considered difficult category to assess. This is because of the potential
to be sentinel events). Other more subtle risks can include size of this group and the variety of persons that can be
excess radiation exposure (because of failure to adequately included. Another potential difficulty is that the individu-
shield the patient from repeat images), exposure to infec- als within this group probably have little or no knowledge
tious disease (because of failure of the technologist to of the policies and procedures of the healthcare institution.
maintain room cleanliness), and breach of confidential- The greatest potential risks to members of this group are
ity (because of technologists discussing patient informa- injuries from falling, exposure to infectious disease, and
tion near waiting areas or other unauthorized persons). HIPAA violations (such as they may not have knowledge
These potential risks can be reduced by having the appro- of privacy concerns). It is imperative to have appropriate
priate policies and procedures in place and ensuring that policies and procedures in place to address these risks and
employees have knowledge of and follow these procedures. to encourage employees (because they should have been
Accrediting agencies such as TJC and DNV-GL publish educated in risk management) to report any hazardous
extensive safety guidelines for patients for various types of conditions (e.g., liquid spills) immediately.
• O
nce a risk analysis is performed and policies and pro- • P eriodic inspection—to ensure that all policies and procedures
cedures have been created to reduce any potential risks, are being implemented
the next step in a risk management program is to create • Record keeping—to document that all policies and procedures
an investigation procedure for any incidents that may have been implemented
occur. An incident is any occurrence that is not con-
sistent with the routine care of a patient or the normal
course of events at a particular facility. Facilities should
RADIATION SAFETY PROGRAM
have some type of “incident report” form that is to be Diagnostic imaging procedures (with the exception of MRI
completed as soon as possible after an incident. The and sonography) contribute the largest single exposure to
completed reports should be reviewed immediately by artificial radiation (more than 90%) in the United States. The
the department manager and then forwarded to the risk average effective dose equivalent for diagnostic radiographs
manager for additional review. The risk manager should is 39 millirem (mrem) (0.39 millisievert [mSv]) and 14 mrem
then determine whether any follow-up action is neces- (0.14 mSv) for nuclear medicine procedures. This is in addi-
sary. This can include additional investigation, notifica- tion to the 360 mrem (3.6 mSv) per year that is received from
tion of government agencies (e.g., the Food and Drug natural sources such as cosmic radiation (from outer space),
Administration [FDA], OSHA, the Nuclear Regulatory terrestrial radiation (from the earth, air, and drinking water),
Commission [NRC], the Environmental Protection and internal radiation (from our own body tissues). The 360
Agency), or the obtainment of legal counsel. A risk man- mrem (3.6 mSv) per year is an average for the United States
agement program also should include policies and pro- and can vary considerably from one location to the next.
cedures addressing claims prevention and loss potential. Persons who live in areas where the altitude is high or where
Loss potential refers to any activity that costs a facility exposure to radon-222 is common may experience consid-
either money or its reputation. Educating employees erably more than 360 mrem per year. It is therefore imper-
on safety policies and procedures, emphasizing quality ative that patients, visitors, hospital staff, and radiographers
patient care, and communicating effectively within the themselves receive as little radiation exposure as possible. It is
healthcare facility can greatly reduce the occurrence of the primary responsibility of each radiographer to ensure that
incidents and therefore the cost of defending any claims this indeed occurs. A quality management program should
that may result from these incidents. With these policies have radiation safety policies and procedures in place to make
in place and documentation that they are being imple- sure that all employees who administer ionizing radiation to
mented, loss potential can be reduced, first by minimiz- patients are aware of this responsibility. The NRC (or state
ing the chance of an incident and second by showing radiation governing body) and TJC require a radiation safety
that the healthcare facility did all that it could to mini- committee, administered by a radiation safety officer, to
mize risk, which should cast a more favorable opinion if implement these policies. Additional responsibilities of this
litigation becomes necessary. committee would include creating policies and procedures
for the safe handling and disposal of radioactive materials,
Policies and Procedures radiation accidents, and care of patients exposed to radiation.
Finally, if an incident does occur, a risk management Implementation of proper radiation safety protocols is
program should have policies and procedures in place mandated by the federal government and most state gov-
that address responsibility of the healthcare institution ernments. The more important federal laws are described
for the outcome of the incident, for example, paying the in this chapter. The enactment of the laws mentioned earlier
medical bills for a patient or employee who is injured in in this chapter means that diagnostic imaging professionals
a diagnostic imaging department. Having effective poli- may have to interact with one or more regulatory agencies
cies and procedures addressing this type of responsibility that oversee compliance. These federal agencies include the
and loss can often prevent the filing of a claim or reduce following:
the amount of a claim after litigation. As with all quality • The FDA. As mentioned previously, the FDA, through the
management components, keeping proper records of all Center for Devices and Radiological Health, regulates the
incidents, documents, reports, and policies is imperative design and manufacture of x-ray equipment. These regu-
for the process to be successful. The following list sum- lations are contained in the document Title 21 of the Code
marizes the key concepts of an effective risk management of Federal Regulations Part 1020 (21 CFR 1020). Title 21
program: refers to the FDA. The FDA also must certify the admin-
• Risk analysis—to identify all potential hazards and risks istrative, professional, and technical aspects of mam-
that can occur mographic services in order to obtain Medicare and most
• Written policies and procedures—to reduce all risks and private insurance reimbursement. The FDA uses three
deal with incidents as they occur classifications of all medical devices:
• Employee education—to inform employees of all policies • Class I—general controls: Class I devices are subject to
and procedures, as well as seek input from employees the least regulatory control and present minimal poten-
(such as a brainstorming session) to identify and reduce tial for harm to the user. Examples would include image
further risks receptors, grids, and lead aprons.
• Class II—special controls: Class II devices are those for can compensate for overexposure to radiation when it dis-
which general controls alone are insufficient to assure plays the final image on the monitor. This can lead tech-
safety and effectiveness. In addition to complying nologists to become careless in their milliampere-second
with general controls, class II devices also are subject selection; they can overexpose the patient, resulting in
to special controls. Examples would include collima- dose creep. This is an increase in patient radiation expo-
tors, pressure injectors for contrast media, and barium sure that occurs in CR and DR imaging, because these sys-
enema tips. tems can compensate for overexposure up to 500% above
• Class III—premarket approval: Class III is the most the ideal amount but only compensate for underexposure
stringent regulatory category for devices. Class III of about 60% below the ideal value. It is extremely import-
devices are those for which insufficient information ant to adhere to your system’s recommended exposure
exists to ensure safety and effectiveness solely through indicator values (e.g., DI numbers, S-numbers) to avoid
general or special controls. Class III devices are usually overexposure to your patient. The radiographer must keep
those that support or sustain human life; are of substan- in mind that the kilovolt (peak) that is used must be kept
tial importance in preventing impairment of human in an optimum range for the particular part of the body
health; or present a potential, unreasonable risk of ill- that is being radiographed, because excessive kilovolt
ness or injury. Examples include angioplasty catheters (peak) can produce images that may be of poor diagnostic
and cardiovascular stents. quality (especially with film/screen image receptors).
• The NRC. This agency is responsible for enforcing both • Use of high-speed image receptor systems. This is the sec-
equipment standards and radiation safety practices. This ond most effective method of reducing patient exposure,
information is published in Title 10 of the Code of Fed- because a faster-speed system requires a lower mAs value
eral Regulations Part 20 (10 CFR 20). Title 10 refers to to obtain a diagnostic image. With conventional film/
the Department of Energy, which contains the NRC. In screen imaging systems, most departments use rare-earth
some states called agreement states, the NRC allows the phosphors that are high speed and demonstrate acceptable
state to have the responsibility to enforce equipment stan- recorded detail. When deciding which image receptor to
dards and radiation safety practices. As of the writing of use, one must consider that faster-speed film/screen sys-
this edition, there are currently 37 agreement states. The tems can demonstrate poorer resolution than slower-speed
nonagreement states are Montana, Idaho, South Dakota, systems. Most current CR and DR systems possess a sys-
Missouri, Indiana, Michigan, West Virginia, Connecticut, tem speed that is comparable to a 200-speed to 300-speed
Delaware, Alaska, Hawaii, as well as Washington, DC. The film/screen system.
states of Vermont and Wyoming have signed a letter of • Use of proper filtration. Filtration removes lower-energy
intent to become agreement states. x-rays from the primary beam before contact with the
• OSHA. This agency is responsible for establishing stan- patient. This can reduce the patient’s entrance skin dose
dards for safety and monitoring the workplace envi- by as much as 90%. There is usually a certain amount of
ronment, including the requirements for occupational inherent filtration (filtering performed by the window
exposure to radiation, handling and disposal of hazardous of the x-ray tube, as well as any cooling oil) present and
materials, universal precautions (Tier 1) for protection added aluminum or copper between the x-ray tube win-
of employees from infectious diseases, and personal pro- dow and the top of the collimating device.
tective equipment. This information is contained in Title • Use of the smallest field size possible, along with proper
29 of the Code of Federal Regulations Part 1910 (29 CFR collimation. This reduces the amount of the patient’s
1910). Title 29 refers to OSHA. body that is exposed to radiation, thereby reducing the
total dose. The effect of field size can be seen by calcu-
Patient Radiation Protection lating a value known as the dose area product (DAP)
Radiographic Examinations or kerma area product (KAP). These values incorpo-
The federal government recommends that the “as low as rate the total dose of radiation or air kerma value along
reasonably achievable” (ALARA) concept be used during with the area of field that is being used. The units that
all diagnostic x-ray procedures. ALARA is covered in detail can be used to measure DAP can be roentgen × square
in the National Council on Radiation Protection (NCRP) centimeter (R × cm2); coulomb per kilogram × square
Report #107. Some of the main recommendations of the centimeter (C/kg × cm2); or rad × square centimeter
ALARA program for radiographic examinations include the (R × cm2). For KAP measurement, the milligray ×
following: square centimeter (mGy × cm2) or microgray × square
• Use of high kilovolt (peak) (kVp) and low milliampere-second centimeter (μGy × cm2) may be used. For example, a
(mAs) exposure factors. This is the most effective method field size of 5 cm × 5 cm (25 cm2) can receive a dosage
of reducing patient exposure because milliampere-second of 4 R, yielding a DAP of 100 R × square centimeter. A
selection is the primary control of the quantity of radiation field size of 20 cm × 20 cm (400 cm2) can receive a much
emitted by the x-ray source. This is even more critical with lower dose of only 0.25 R but still yield the same DAP of
computed radiographic (CR) systems and digital radio- 100 R × square centimeter because of the increase in the
graphic (DR) systems. With these systems, the computer size of the x-ray field.
• U se of optimum processing conditions. Regardless of whether Fluoroscopic Examinations

one is using film/screen radiography or a digital radio- Fluoroscopic examinations have the potential to deliver
graphic imaging system, proper image processing must a considerable dose of radiation to the patient. Therefore
exist in order to obtain consistent image quality. Automatic ALARA protocols, including the following, should be in place
film processor quality control is extremely important in for these examinations:
lowering the patient dose in conventional film/screen radi- • Ensure that the fluoroscopic system does not exceed max-
ography. For example, if the developer temperature were imum entrance exposure or air kerma rates. Fluoroscopic
too low, the resulting radiographs would appear to lack systems that are provided with automatic exposure rate
optical density. This can lead to a repeat image (increasing control (AERC) shall not be operable at any combination
the dose for that particular patient) or to an increase in of tube potential and current that will result in an expo-
technical factors for subsequent images (increasing patient sure rate (air kerma rate) in excess of 2.58 × 10−3 coulomb
dose for all subsequent patients). For CR and DR systems, per kilogram per minute (C/kg/min) (10 roentgens per
proper manipulation of both preprocessing and postpro- minute [10 R/min] or 100 mGy/min at the point where
cessing software factors by the radiographer is necessary to the center of the useful beam enters the patient). AERC,
obtain proper image quality. also known as automatic brightness control or automatic
• Avoidance of repeat examinations. The ideal overall brightness stabilization (abs), are systems that adjust x-ray
repeat rate for diagnostic imaging departments is no output parameters when moving from various regions of
greater than 4% to 6% (2% for mammographic proce- the body to maintain uniform image brightness. Fluoro-
dures). This figure can vary depending on the patient scopic systems that are not provided with AERC shall not
population and acceptance standards of a particular be operable at any combination of tube potential and cur-
imaging department but should never exceed 10% to rent that will result in an exposure rate (air kerma rate)
12%. Proper patient instructions, along with correct in excess of 1.29 × 10−3 C/kg/min (5 R/min or 50 mGy/
positioning and technique selection by the radiographer, min) at the point where the center of the useful beam
should help reduce the need for repeat examinations. enters the patient. For systems equipped with high-level
Digital radiographic systems can reduce the repeat rate control (HLC), the fluoroscopic system shall not be oper-
attributable to technique error, because postprocessing able at any combination of tube potential and current that
software can yield some correction of image brightness will result in an exposure rate (air kerma rate) in excess
(optical density in film/screen imaging) and image gray- of 5.16 × 10−3 C/kg/min (20 R/min or 200 mGy/min) at
scale (contrast in film/screen imaging). Proper position- the point where the center of the useful beam enters the
ing is extremely important when automatic exposure patient. Special means of activation of high-level controls
control devices are used with both film/screen imaging shall be required. The high-level control shall only be
(to be sure that the correct portion of the anatomy is operable when continuous manual activation is provided
over the cell that has been selected) and with CR and DR by the operator. A continuous signal audible to the fluo-
systems (because the computer must compare the image roscopist shall indicate that the high-level control is being
obtained with its preprogrammed ideal image to obtain employed.
the correct image). • Keep fluoroscopic milliampere (mA) and time as low as
• Use of a posteroanterior (PA) projection instead of an possible when performing fluoroscopy. The mA is usually
anteroposterior (AP) projection for scoliosis series on young kept in a relatively narrow range (0.5 to 3 mA), and so
female patients. Normally, radiographic views of the spine reducing the fluoroscopic time is one of the most effec-
are performed with an AP projection to place the spine tive means of reducing patient dose during fluoroscopic
as close to the image receptor as possible. However, the procedures.
breast tissue in female adolescents is extremely sensitive to • Use high kilovolt (peak) if possible. Fluoroscopic exam-
the development of radiation-induced breast cancer (with inations should be performed in the 85-kVp to 125-kVp
a latent period of 5 to 15 years). When the examination is range (depending on the contrast media being used). The
performed with the PA projection instead of the AP pro- use of a higher kilovolt (peak) reduces the fluoroscopic
jection, the breast tissue receives the exit dose instead of mA required to obtain adequate image brightness, thereby
the entrance dose of radiation. This can reduce the mean reducing the patient’s dose.
glandular dose to the breast tissue by as much as 98%. • Limit field size as much as possible. This is done with the
Shielding of the breast areas with specialized devices also fluoroscopic collimation shutters and with a smaller image
should be used to reduce the dose even further. intensifier. This has the same effect as collimation, which
• Use of gonadal shielding. Gonadal shielding with at least was previously discussed.
0.5-mm lead equivalence should be used whenever the • Use intermittent fluoroscopy (periodic activation of the fluo-
gonads lie within 5 cm of the collimation line and do not roscopic x-ray tube rather than continuous activation). This
interfere with the anatomy of interest. This can reduce can reduce patient dose by as much as 90%. Many depart-
the dose to the reproductive organs by as much as 90%. ments have incorporated a procedure of recording the
Gonadal shielding may be a flat contact, a shaped contact, total fluoroscopic exposure time of a patient in their med-
or a shadow type of shield. ical records or in a department log sheet. This information
also should include the name of the radiologist/physician TABLE 1.3 Fluoroscopy DRL’s and AD’s
who performed the fluoroscopy, along with the patient
case number. Phantom: Adult PA
• Use the last-image-hold feature. This feature holds the last Abdomen with Grid DRL AD
image obtained in digital storage and displays it on the Upper GI fluoroscopy, 54 mGy/min 40 mGy/min
monitor. This can reduce total fluoroscopic time by 50% to without oral contrast
80%. media
• Avoid the magnification mode. The magnification mode Upper GI fluoroscopy, 80 mGy/min 72 mGy/min
with oral contrast
found with multifield tube-type image intensifiers can media
increase patient dose 2 to 10 times that of the standard
mode. This is because the magnification mode reduces the Fluorographic image, without contrast
brightness gain of the image intensifier tube, requiring an Film 3.9 mGy 2.5 mGy
increase in fluoroscopic milliampere to compensate. Digital 1.5 mGy 0.9 mGy
• Keep the patient-to-image intensifier distance as short as Fluorographic image, with contrast
possible during mobile fluoroscopic studies with a C-arm. Film 27.5 mGy 18.7 mGy
Digital 9.9 mGy 5.3 mGy
This reduces the source-to-skin distance to the patient.
• Reduce the number of spot images, and reduce the spot AD, Achievable dose; DRL, diagnostic reference level; GI, gastroin-
image size. Patient dose increases as the number of spot testinal; PA, posteroanterior.
images increases. In addition, larger spot size formats
require more radiation; therefore patient dose is increased. For the values reported in Table 1.4, the 16-cm-diameter
Diagnostic Reference Levels. In addition to these ALARA phantom was used for all head and pediatric abdomen CT
concepts, radiology departments should be aware of Diag- examinations, and the 32-cm-diameter phantom was used for
nostic Reference Levels (DRL). According to the ACR all adult body CT examinations.
and the American Association of Physicists in Medicine, a Patient Dose Tracking. Diagnostic medical imaging per-
diagnostic reference level (DRL) is an investigational level forms over 4 billion studies worldwide each year, which
used to identify unusually high radiation doses for common means that populations are being exposed to increasing doses
diagnostic medical x-ray imaging procedures. DRLs are sug- of ionizing radiation. The majority of this exposure is justi-
gested action levels above which a facility should review its fied, with medical benefits for patients, but reports in a vari-
methods and determine whether acceptable image quality ety of clinical settings have identified a number of radiologic
can be achieved at lower doses. DRLs are based on standard examinations that may not meet appropriateness criteria. The
phantom or patient measurements under specific conditions International Atomic Energy Agency (IAEA) initiated the
at a number of representative clinical facilities. DRLs have Smart Card project in 2006, with the objective of developing
been set at approximately the 75th percentile of measured a flexible template for tracking cumulative radiation exposure
patient or phantom data. This means that procedures per- (number and type of radiologic procedures) and wherever
formed at 75% of the institutions surveyed have exposure possible dose for individual procedure. This program was
levels at or below the DRL. Achievable dose (AD) can be subsequently named as SmartCard/SmartRadTrack. This
used with DRLs to assist in optimizing image quality and was to dispel the myth that the purpose is to develop a card
dose. ADs are set at approximately the median (50th percen- that contains patient dose history and to indicate a mecha-
tile) of the study dose distribution; that is, half of the facili- nism to track procedures and doses. Since that time, efforts
ties are producing images at lower doses and half are using worldwide have begun to require patient dose tracking for
higher doses. The DRL and AD values from these two groups diagnostic imaging examinations and have this information
are as follows: become part of the patient’s electronic health record. Exam-
Radiography. For radiography, including screen-film and ples include:
digital imaging, this practice parameter bases DRLs and ADs 1. Veterans Health Administration—The VHA Handbook
on a measurement of air kerma in milligray at the skin plane dated July 6, 2012, states that “A record must be kept of
(without backscatter) to a standard phantom using the x-ray each fluoroscopic procedure”. The record must list the flu-
technique factors the facility would typically select for an oroscopy unit, date of the procedure, type of procedure,
average size adult or pediatric patient (see Table 1.1). information identifying the patient, and the name of the
Fluoroscopy. For fluoroscopy, the DRLs and ADs are based physician operating or directing the operation of the
on a measurement of air kerma in milligray at the skin plane device. The record must also list the cumulative fluoros-
(with some backscatter caused by the geometry) to a standard copy time, number of static images, total time of dynamic
phantom using the x-ray technique factors the facility would cinefluorography (CINE) series, the cumulative air kerma
typically select for an average size adult patient. Published ref- or skin dose from both fluoroscopy and from static
erence levels are currently not available for pediatric patients image recording, if available, and the dose-area-product,
(see Table 1.3). if available. Dose can be stored as a Digital Imaging and
Computed Tomography. The DRLs and ADs for CT are Communications in Medicine (DICOM) Radiation Dose
based on the volume CT dose index (CTDIvol) in milligray. Structured Report (RDSR).
TABLE 1.4 Computed Tomography DRL’s, AD’s, and CTDI

Patient Lateral Dimension CTDI Phantom Diameter (cm) DRL (mGy) AD (mGy)
Adult head 16 16 75 57
Adult abdomen-pelvis 38 32 25 17
Adult chest 35 32 21 14
Pediatric 5-year-old head 15 16 40 31
Pediatric 5-year-old abdomen- 20 16 20 14
pelvis
AD, Achievable dose; CTDI, computed tomography dose index; DRL, diagnostic reference level.
2. The Joint Commission—Revised TJC requirements also sievert (5 rem), 0.5 sievert (50 rem) to a specific organ
specify that the radiation dose of every CT examination or tissue, and 0.5 sievert (50 rem) shallow dose to the
must be recorded, and that high-radiation-dose incidents skin. The volume computed tomography dose index
must be evaluated against industry benchmarks (found (CTDIvol) or dose length product (DLP) is required to
under the Provision of Care, Treatment, and Services calculate the effective dose equivalent. It also requires
PC.0102.15: that CT departments must be accredited in CT by an
• The [critical access] hospital documents in the patient’s organization that is approved by the Centers for Medi-
record the radiation dose index (CTDIvol, DLP, or care and Medicaid Services (CMS).
size-specific dose estimate [SSDE]) on every study pro- • Texas—Texas Administrative Code 25 TAC 289.227
duced during a diagnostic computed tomography (CT) took effect in May 2013. One provision of the law is for
examination. The radiation dose index must be exam- departments to establish Radiation Protocol Commit-
ination specific, summarized by series or anatomic tees (RPC) for CT systems and fluoroscopically guided
area, and documented in a retrievable format. interventional procedures. These committees are
• The [critical access] hospital reviews and analyzes inci- responsible for establishing diagnostic reference levels
dents where the radiation dose index (CTDIvol, DLP, (DRL) for these procedures, specify methods that are
or size-specific dose estimate [SSDE]) from diagnostic to be used to monitor radiation output for these pro-
CT examinations exceeded expected dose index ranges cedures, and specify actions that are to be taken when
identified in imaging protocols. These incidents are reference levels are exceeded. For fluoroscopy, the RPC
then compared with external benchmarks. must make and maintain a record of radiation output
3. The American College of Radiology—The ACR hosts a information so that the radiation dose to the skin may
Dose Index Registry (DIR) that allows facilities to com- be estimated, and must include cumulative air kerma
pare their CT dose indices to regional and national val- or dose area product (if available on system) and Flu-
ues. The information collected is masked, transmitted to oro mode, cumulative exposure time, and number of
the ACR, and stored in a database. Facilities receive quar- recorded exposures. The RPC for CT systems must
terly feedback reports comparing their results to aggregate make and maintain a record of radiation output infor-
results by body part and examination type. According to mation so that the radiation dose to the skin may be
TJC, the ACR DIR provides benchmark data. The intent estimated using CTDIvol and DLP (if system capable
of Performance Improvement Standard PI.02.01.01 is to of calculating and displaying) or an index described
ensure that the organization is committed to dose optimi- by the American Association of Physicists in Medicine
zation and stays current with standard of practice. Because (AAPM) Task Group 111.
the frequency of data collection and analysis is under the It is expected that more states and the federal government
organization’s purview, participation in the ACR DIR will expand patient dose tracking or dose monitoring require-
would meet compliance with PI.02.01.01. ments in the near future. Luckily, commercial dose-tracking
4. Individual State Requirements—as of the writing of this software packages are available to accomplish this task (see
edition, the states of California and Texas have enacted Table 1.5 for a listing of leading dose management software).
legislation to require patient dose tracking in certain radio- Features of these systems include transmission of dose infor-
logic procedures. The state of Ohio has proposed dose mation from imaging device or PACS, advanced analysis and
tracking of cumulative air kerma or dose area product/ reporting capabilities, and ability to integrate with PACS, RIS,
kerma area product for fluoroscopic procedures involving and HER systems. Problems that have been encountered with
interventional procedures and cardiac catheterization of patient dose-tracking software include no uniform dose met-
pediatric or pregnant patients. rics across all systems and difficulty working on older equip-
• California—Senate Bill 1237 took effect in January ment.
2011, and requires the reporting to the State of Cali-
fornia–Health and Human Services Agency all CT Visitor Protection
scans that are repeated or occurred to the wrong body “Visitors” to diagnostic imaging departments are persons
part that exceeded an effective dose equivalent of 0.05 other than patients or radiology department staff. They may
TABLE 1.5 Various Dose Management/Patient Dose-Tracking Software Vendors and

Products
Company Product URL
Agfa Healthcare Dose Monitor www.dosemonitor.com
Bayer Healthcare LLC Radimetrics Enterprise Platform www.radimetrics.com
GE Healthcare DoseWatch www3.gehealthcare.com
GE Healthcare DoseWatch Explore www3.gehealthcare.com
Medic Vision Imaging Solutions Ltd. SafeCT-29 http://www.medicvision.com/usa/
Medic Vision Imaging Solutions Ltd. SafeCT Dose Report http://www.medicvision.com/usa/
Medic Vision Imaging Solutions Ltd. SafeCT Dose Report http://www.medicvision.com/usa/
Medical Physics Software Solutions Medphys360 http://medphys360.com/
Novarad Novadose https://www.novarad.net/
Numa, Inc. Numa (for nuclear medicine and www.numa-inc.com
positron emission tomography)
Primordial Design Primordial http://www.primordialdesign.com/
Philips Healthcare DoseWise Portal http://www.usa.philips.com/healthcare/
clinical-solutions/dosewise
ScImage, Inc. PICOM365 http://www.scimage.com/welcome-to-
picom365-by-scimage/
Sectra Sectra Dosetrak www.sectra.com/medical/dose_monitoring/index
Siemens Healthineers Right Dose https://usa.healthcare.siemens.com/medical-
imaging/low-dose/low-dose-information-by-
modality/low-dose-in-computed-tomography
Volpara Solutions, Inc. VolparaDoseRT http://www.volparasolutions.com/
Volpara Solutions, Inc. Volpara Analytics http://www.volparasolutions.com/
include relatives or friends of patients, hospital volunteers, These persons should be provided with protective apparel
security personnel, or other hospital employees who do not (such as lead aprons and gloves) to prevent overexposure
normally work in radiation areas (e.g., nurses, patient care to radiation that can occur during the procedure. Avoiding
technicians, respiratory therapists). Although these persons repeat exposure is also important in these instances because
are in the diagnostic imaging department or near mobile repeat exposure increases the patient’s and visitor’s dose.
x-ray equipment in use (e.g., the emergency department or
surgical suite), they are entitled to a safe environment with no Personnel Protection
unnecessary exposure to ionizing radiation. The NCRP lists Personnel who perform diagnostic procedures using ionizing
maximum effective dose equivalent limits for members of the radiation can potentially receive significant amounts of radi-
general population in its report, number 116. For members ation and must therefore follow proper radiation practices.
of the general population who may be exposed to frequent or According to NCRP report number 116, maximum total
continuous exposure from artificial sources other than med- effective dose equivalent for occupational personnel are as
ical irradiation (this includes radiography students younger follows:
than 18 years), the NCRP recommends a maximum effective
dose equivalent limit of 0.1 rad equivalent, man (rem) (1 mSv) Whole-body exposure 5 rem (50 mSv) per year
Eye lens 15 rem (150 mSv) per year
per year. For those who may receive infrequent exposure (e.g.,
All other body parts (such 50 rem (500 mSv) per year
a parent who may be asked to hold a child for an x-ray pro- as hands)
cedure), a maximum of 0.5 rem (5 mSv) per year is recom-
mended. To help minimize exposure to department visitors, Examinations in which mobile equipment, fluoroscopy, car-
radiographers can ensure that all examination room doors diac catheterization, and interventional procedures are used
remain closed during radiographic procedures. pose a greater risk of higher dosages to radiographers and
During mobile radiographic procedures, visitors should radiologists assistants than traditional radiographic proce-
leave the area if possible or move at least 8 ft away from the dures. Occupational radiation dosage should be monitored
source of radiation. Visitors who want to accompany patients with a dosimeter obtained from a licensed provider. The
or observe a radiographic examination (such as a prospective most common of these are film badges, optically stimulated
radiography student or a radiology resident) should remain luminescent dosimeters, and thermoluminescent dosimeters.
behind a protective barrier or wear protective apparel, or These are checked at either 1-month or 3-month intervals
both. In some cases (e.g., pediatric patients), a visitor (nurse, with a report sent back to the institution indicating the dosage
patient care technician, parent, or other relative) may be measured. For whole-body measurement, these dosimeters
asked to help hold a patient during a radiographic procedure. are worn at either the waist or collar area. Finger dosimeters
can also be issued in cases where the hands may receive rela- Distance
tively high dosages (i.e., nuclear medicine technologists and Radiographers should always maintain as large a distance as
interventional technologists). possible between the source of radiation and themselves. The
The embryonic/fetal dose of occupational workers should reason is that radiation continually diverges from its source,
not exceed 0.0025 mrem (0.025 mSv) per day, 0.05 rem and so as distance is increased, less radiation exists per unit
(0.5 mSv) in any 1 month of the 9-month gestation period, area. Reduction in radiation intensity follows an inverse
and 0.5 rem (5 mSv) for the entire gestation period. When a square relationship and can be determined from the follow-
radiographer, radiologist, or radiologist assistant has confir- ing equation:
mation that she is pregnant, she must first declare her preg- New intensity Old distance2
nancy to her employer, or many institutions will not accept =
Old intensity New distance2
liability for proper precautions to protect a pregnant worker
from radiation. Once the declaration is on file, the fetus is For example, if the radiation intensity at 90 cm from a radi-
treated like a member of the general population. Most insti- ation source is 1.3 mGy/min, at 270 cm (3 times the dis-
tutions will also issue a second dosimeter to act as a fetal tance as 90 cm), the radiation intensity is reduced to only
dose monitor. This should be worn at the waist level under a 0.14 mGy/min (nine times less than the amount received at
lead apron. The institution should also provide the pregnant 90 cm). Therefore a small increase in the distance from the
employee a full explanation of the potential risks of fetal radi- source causes a large decrease in the amount of radiation
ation exposure, dose limits, as well as any state, local, or insti- exposure that is received. This factor is especially important
tutional policies. Technologists who become pregnant should in fluoroscopy because it may require the operator of the
not work with patients who have been treated with radionu- x-ray equipment to remain in the examination room. As a
clides because these materials could deliver a dose that would rule of thumb, the occupational radiation exposure during
exceed acceptable limits. tableside fluoroscopy is about 1 mrem/min. Moving back
Medical facilities must have an orientation program on away from the side of the examination table (if possible) can
radiation safety for newly employed technologists and a significantly reduce this amount according to the inverse
continuing education program to update the skills of all square law. Standing on the image receptor side of a C-arm
department personnel. Personnel who work in proximity to fluoroscopic unit rather than the x-ray tube side will also
radiographic and fluoroscopic procedures (e.g., emergency minimize radiation dose.
department, operating room, intensive care unit) also should
have the same in-service training. Shielding
Periodic surveys with properly calibrated instruments Any material that can be placed between a person and a
such as Geiger Müller counters and ionization chambers source of radiation is considered shielding. Materials with
should be performed to assess that radiation in the workplace a high atomic number (such as lead) that are not natu-
does not exceed accepted standards. Warning signs marked rally radioactive are best for shielding because the greatest
“Caution: Radiation Area” should be posted for any areas amount of photoelectric absorption occurs in these mate-
where dosage can exceed 5 milliroentgen (mR)/h or 0.05 rials. Shielded booths are required for protecting the area
milligray (mGy)/h. The cardinal principles of radiation pro- around the control panel of radiographic units. The walls
tection (time, distance, and shielding) should be followed by of the examination room are designed to protect person-
all radiologic technologists to minimize their occupational nel, other hospital employees, and the general public from
exposure. unnecessary exposure. Lead aprons and gloves must be
provided to employees when the possibility of exposure
Time rate could exceed 5 mR/h (i.e., technologists who must be
Radiographers should keep the time of exposure to radiation outside of the control booth during fluoroscopic or mobile
as short as possible because the amount of exposure is directly procedures). Lead aprons must have a minimum lead
proportional to the time of exposure, as indicated by the fol- equivalent thickness of at least 0.25 mm and cover 75% to
lowing equation: 80% of the active bone marrow of the person wearing it.
Protective gloves require a minimum lead equivalent thick-
Total exposure = exposure rate × time
ness of 0.25 mm, with 0.5 mm preferred. Thyroid shields
The exposure rate is the output of radiation from the source are available for general fluoroscopic, angiographic, and
per unit time. For example, if a radiation source creates an interventional procedures and must have a minimum lead
exposure rate of 225 mR/h at a position occupied by an occu- equivalent thickness of 0.5 mm. Protective eyeglasses with
pational worker, and the worker remains at that position for a minimum lead equivalence of 0.35 or 0.5 mm are also
36 min, what is the total exposure? available. Fluoroscopic and cardiovascular/interventional
Total exposure = (225 mR/h) × (36/60h) = 135mR suites can also be equipped with leaded shields made of
either radiation-absorbing acrylic or glass panels that are
The factor of time is especially important during fluoroscopic, mounted on wheels for portability or are suspended from
angiographic, and interventional procedures. the ceiling.
S U M M A R Y
In modern diagnostic imaging departments, the radiologists, program’s effectiveness in meeting the objectives, and the effi-
department administrators and supervisors, technologists, cacy of the program. Having an effective quality management
and support staff should work together to ensure that ade- program also has become necessary as a condition of receiv-
quate processes are in place to properly care for the patient, ing reimbursement for services by the federal government
achieve the highest-quality image possible, and obtain the and many private insurance companies.
correct diagnosis from that image. These processes also are Implementing a quality management program requires
necessary to meet accreditation standards or government considerably more than just equipment monitoring and
requirements, or both. The processes also should be reviewed maintenance. A basic knowledge of administrative respon-
continuously by all parties and modified as the need arises. sibilities, risk management, and radiation safety practices is
Any quality management plan should have specific objectives essential in order for a quality management technologist to
(what the program is intending to achieve), an outline of the implement a successful quality management program.
chain of command and responsibilities within the organiza- Refer to the Evolve website at https://evolve.elsevier.com
tion, the scope of the program, a mechanism for monitoring for Student Experiment 1.1: Attenuation or Transmission of
various aspects of patient management, evaluation of the Radiation.
R E V I E W Q U E S T I O N S
1. Which levels of quality control testing can usually be per- 6. The unit of measure used to express the dose equivalent
formed by a quality assurance/quality management tech- to occupational workers is which of the following?
nologist: level I, level II, or level III? a. Coulomb/kg of air
a. I and II b. Gray
b. I and III c. Sievert
c. II and III d. Relative biological effectiveness
d. I, II, and III 7. Which of the following does not affect patient dose
2. Which government agency mandates a policy on expo- during diagnostic radiography?
sure to blood-borne pathogens? a. Inherent filtration
a. FDA b. Added filtration
b. EPA c. Focal spot size
c. OSHA d. Source-to-image distance
d. CDRH 8. The current U.S. regulatory dose limit to the fetus of a
3. Which of the following terms best describes information radiation worker is:
or knowledge necessary to achieve a desired outcome? a. 0.1 mSv/month
a. Supplier b. 0.2 mSv/month
b. Input c. 0.5 mSv/month
c. Action d. 1.0 mSv/month
d. Output 9. The current U.S. regulatory dose limit for the annual
4. Which of the following terms best describes a person, whole-body effective dose to radiation workers is:
department, or organization that needs or wants a desired a. 1 mSv
outcome? b. 5 mSv
a. Supplier c. 20 mSv
b. Input d. 50 mSv
c. Action 10. Who regulates the use of radioactive materials in the
d. Customer United States?
5. Who is considered to be the “Father of Scientific Manage- a. NAS-BEIR
ment”? b. NRC
a. W. Edwards Deming c. NCRP
b. Joseph Juran d. FDA
c. Raymond Smith
d. Frederick Winslow Taylor

Introduction To Quality Management: Outline

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Introduction To Quality Management: Outline

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