2025

Noninterpretive
Skills

Study Guide

This study guide is to be used in preparation for all Diagnostic Radiology Core and
Certifying exams administered through calendar year 2025.
 Table of Contents

Introduction .........................................................................................................................................................4
Chapter 1. Core Elements of Professionalism ........................................................................................................5
1.1 ABIM Physician Charter for Medical Professionalism in the New Millennium .............................................. 5
1.2 Ethical Considerations Specific to Radiology .............................................................................................. 7
Chapter 2. Core Concepts of Quality and Safety ....................................................................................................9
2.1 Core Concepts of Quality........................................................................................................................... 9
2.1.1 Introduction to Quality .................................................................................................................... 9
2.1.2 Quality as a Discipline ...................................................................................................................... 9
2.1.3 2001 Institute of Medicine Report, Crossing the Quality Chasm ...................................................... 10
2.1.4 Core Competencies of the ABMS and ACGME................................................................................. 11
2.2 Core Concepts of Safety .......................................................................................................................... 12
2.2.1 2000 Institute of Medicine Report, To Err is Human........................................................................ 12
2.2.2 2015 Institute of Medicine Report, Improving Diagnosis in Health Care........................................... 12
2.2.3 Human Factors .............................................................................................................................. 14
2.2.4 Human Error ................................................................................................................................. 16
2.2.5 Culture of Safety ........................................................................................................................... 16
Chapter 3. Practical Quality and Safety Applications in Healthcare ..................................................................... 20
3.1 Practical Quality Applications in Healthcare ............................................................................................. 20
3.1.1 Daily Management Systems ........................................................................................................... 20
3.1.2 Project-based Improvement Methods............................................................................................ 21
3.2 Practical Safety Applications in Healthcare .............................................................................................. 27
3.2.1 Periprocedural Care....................................................................................................................... 27
3.2.2 Hand Hygiene................................................................................................................................ 30
3.2.3 Root Cause Analysis....................................................................................................................... 31
Chapter 4. Practical Safety Applications in Radiology .......................................................................................... 33
4.1 MR Safety............................................................................................................................................... 33
4.1.1 Zoning and Screening .................................................................................................................... 33
4.1.2 Implanted Devices ......................................................................................................................... 35
4.1.3 MR and Pregnancy ........................................................................................................................ 36
4.1.4 MR-induced Burns ......................................................................................................................... 36
4.1.5 Quenching .................................................................................................................................... 37
4.2 Management of Intravascular Contrast Media ......................................................................................... 37
4.2.1 Iodinated Contrast Media .............................................................................................................. 37
4.2.2 Gadolinium-based Contrast Media (GBCM) .................................................................................... 45
4.2.3 Treatment of Acute Contrast Reactions.......................................................................................... 49
Chapter 5. Reimbursement, Regulatory Compliance, and Legal Considerations in Radiology............................... 53
5.1 Reimbursement and Regulatory Compliance ........................................................................................... 53
5.1.1 Coding, Billing, and Reimbursement............................................................................................... 53
5.1.2 Patient Privacy and HIPAA ............................................................................................................. 55
5.1.3 Human Subjects Research.............................................................................................................. 56
5.2 Malpractice and Risk Management.......................................................................................................... 57
5.2.1 General Principles of Malpractice................................................................................................... 57
5.2.2 Malpractice Related to Diagnostic Errors........................................................................................ 58
5.2.3 Malpractice Related to Procedural Complications........................................................................... 59

2025 Noninterpretive Skills Study Guide 2

 5.2.4 Malpractice Related to Communications Deficiencies ..................................................................... 59
5.2.5 Discoverability of Communications ................................................................................................ 62
Chapter 6. Core Concepts of Imaging Informatics ................................................................................................63
6.1 Standards ............................................................................................................................................... 63
6.2 The Reading Room Environment ............................................................................................................. 63
6.3 From Order to Report: Workflow Considerations ..................................................................................... 65
6.4 Data Privacy and Security ........................................................................................................................ 65
6.5 Image Post-processing and Artificial Intelligence...................................................................................... 66
6.6 Image Artificial Intelligence ..................................................................................................................... 66

2025 Noninterpretive Skills Study Guide 3

 Introduction
This study guide has been created to assist examinees in preparing for the noninterpretive skills (NIS)
section of the American Board of Radiology (ABR) Core and Certifying exams administered through
calendar year 2025.
The guide has undergone a few changes compared to the 2021 version. The primary changes in this
version are the expansion of Artificial Intelligence concepts in Informatics and additional content on
decision support to the regulatory chapter. Details of contrast safety and MR safety have also been
updated, reflecting new published guidelines.
The determination of whether specific NIS topics merit inclusion in the study guide—and on the
exams—is based primarily on two factors. First, material contained in the NIS section should reflect
knowledge that is needed to perform effectively in a modern radiology practice. Second, the public
interest should be served by expecting the examinee to know the material.
Core Elements of Professionalism were deemed to merit inclusion because they reflect basic principles
to which all physicians, including radiologists, should adhere. Core Concepts of Quality and Safety
were included because they reflect underlying principles that drive quality and safety in any complex
environment. Practical Quality and Safety Applications in Healthcare contain quality and safety
strategies as they are applied to healthcare. Practical Safety Applications in Radiology focus on
radiology-specific topics such as MR safety and management of intravenous contrast material.
Reimbursement, Regulatory Compliance, and Legal Considerations in Radiology reflect mechanisms
that external parties use to ensure quality and safety in radiology practice. Informatics and artificial
intelligence represent a growing area where knowledge is integral to the modern practice of Radiology.
The guide covers the majority of general conceptual and practical NIS information contained in the
Core and Certifying exams. However, questions on important subspecialty-specific quality and safety
knowledge and skills are also included on the exams that are not included in this guide, especially
those related to nuclear medicine and other procedure-based specialties. Examinees should be
knowledgeable in basic quality and safety practices relevant to all subspecialties regardless of whether
they are included in this study guide. Physics topics, including radiation safety, are on the exam but
not included in the NIS section.
Examinees are expected to understand general NIS concepts rather than esoteric details. For example,
examinees should understand regulatory requirements that are relevant to daily radiology practice, as
well as their underlying purpose. Less emphasis is placed on more superficial details, such as the
names of the various regulatory agencies.
This study guide will continue to evolve in future years to reflect continuing changes in the non-
interpretive knowledge and skills needed to practice effectively in a modern radiology practice.
We also draw your attention to the references provided at the end of each chapter. We recommend that
you consult these “deeper” resources, which provide perspective and depth of understanding of the
concepts that are only superficially outlined in this study guide.

2025 Noninterpretive Skills Study Guide 4

Chapter 1: Core Elements of Professionalism

1.1 ABIM Physician Charter for distribution of healthcare resources.

Medical Professionalism in the New Physicians should work actively to
Millennium eliminate discrimination in healthcare.

Merriam-Webster defines a profession as “a The 10 professional responsibilities are

calling requiring specialized knowledge and summarized below:
often long and in- tensive academic 1. Commitment to professional
preparation.” Professionalism, defined as “the competence. Physicians must be
conduct, aims, or qualities that characterize or committed to lifelong learning of
mark a profession or a professional person,” medical knowledge and team skills
has been characterized as the basis of necessary for the provision of quality
medicine’s contract with society. Several care. More broadly, the profession as a
fundamental principles and physician whole must strive to see that all of its
responsibilities that apply to all professionals in members are competent and must
medicine have been specified in a Physician ensure that appropriate mechanisms are
Charter supported by the American Board of available for physicians to accomplish
Internal Medicine (ABIM). Ten professional this goal.
responsibilities support the following three
2. Commitment to honesty with patients.
fundamental principles of medical
Physicians must ensure that patients are
professionalism:
completely and honestly informed
1. Principle of primacy of patient welfare. before the patient has consented to
Physicians must be dedicated to serving treatment and after treatment has
the interest of the patient. Trust is occurred. Medical errors should be
central to the physician-patient communicated promptly to patients
relationship, which must not be whenever injury has occurred.
compromised by market forces, societal Physicians should be committed to
pressures, or administrative exigencies. reporting and analyzing medical
2. Principle of patient autonomy. mistakes to develop appropriate
Physicians must be honest with their prevention and improvement strategies.
patients and empower them to make 3. Commitment to patient confidentiality.
informed decisions about their Physicians are responsible for
treatment. Patients’ decisions about safeguarding patient information.
their care must be paramount, as long as Fulfilling this commitment is more
they are in keeping with ethical practice pressing now than ever before, given
and do not lead to demands for the widespread use of electronic
inappropriate care. information systems. However,
3. Principle of social justice. The medical considerations of public interest may
profession must promote the fair occasionally override this commitment,

2025 Noninterpretive Skills Study Guide 5

 such as when patients endanger others. to harm, decrease health expenses, and
improve access to resources for patients
4. Commitment to maintaining
who need them.
appropriate relations with patients.
Given the inherent vulnerability and 8. Commitment to scientific knowledge.
dependency of patients, certain Physicians should uphold scientific
relationships between physicians and standards, promote research, and create
patients must be avoided. In particular, new medical knowledge and ensure its
physicians should never exploit patients appropriate use. The integrity of this
for any sexual advantage, personal knowledge is based on scientific
financial gain, or other private purpose. evidence and physician experience.
5. Commitment to improving quality of 9. Commitment to maintaining trust by
care. Physicians should not only managing conflicts of interest. Medical
maintain clinical competence, but professionals and organizations can
should work collaboratively with other compromise their professional
professionals to continuously improve responsibilities by pursuing private gain
the quality of healthcare, including or personal advantage, especially
reducing medical errors, increasing through interactions with for-profit
patient safety, improving utilization of companies. Physicians have an
healthcare resources, and optimizing obligation to recognize, disclose to the
outcomes of care. general public, and deal with conflicts of
interest that arise in the course of their
6. Commitment to improving access to
professional duties and activities.
care. Physicians should work
Relationships between industry and
individually and collectively toward
opinion leaders should be disclosed,
providing a uniform and adequate
especially when physicians are
standard of care and reducing barriers
determining criteria for conducting and
to equitable healthcare. These barriers
reporting clinical trials, writing
may be based on education, laws,
editorials or therapeutic guidelines, or
finances, geography, or social
serving as editors of scientific journals.
discrimination. This commitment entails
the promotion of public health and 10. Commitment to professional
preventive medicine, without responsibilities. Physicians have both
promotion of the self-interest of the individual and collective obligations to
physician or the profession. work collaboratively to maximize
patient care, be respectful of one
7. Commitment to a just distribution of
another, and participate in the processes
finite resources. To provide cost-
of self-regulation, including remediation
effective health care, physicians should
and discipline of members who have
work with other physicians, hospitals,
failed to meet professional standards.
and payers to develop evidence-based
The profession should also define and
guidelines for effective use of healthcare
organize the educational and standard-
resources. This includes the scrupulous
setting process for current and future
avoidance of superfluous tests and
members. These obligations include
procedures to reduce patient exposure

2025 Noninterpretive Skills Study Guide 6

 engaging in internal assessment and other matters of policy that affect the
accepting external scrutiny of all aspects quality and safety of care.
of their professional performance.
5. Self-referral. Referring patients to
healthcare facilities in which
radiologists have a financial interest is
1.2 Ethical Considerations Specific to
not in the best interest of patients and
Radiology may violate the Rules of Ethics.
The ABIM professional responsibilities largely
6. Harassment. Radiologists are expected
overlap with the Code of Ethics as described in
to relate to other members of the
the American College of Radiology (ACR)
healthcare team with mutual respect
Bylaws. However, several principles and rules
and refrain from harassment or unfair
of ethics apply specifically to the field of
discriminatory behavior.
radiology, as stated by the ACR.
7. Undue influence. Radiologists should
1. Professional limitations. The Bylaws
seek to ensure that the system of
state that radiologists should be aware
healthcare delivery in which they
of their limitations and to seek
practice does not unduly influence the
consultations in clinical situations where
selection and performance of
appropriate. Any limitations should be
appropriate available imaging studies or
appropriately disclosed to patients and
therapeutic procedures.
referring physicians.
8. Agreements for provision of high-
2. Reporting of illegal or unethical
quality care. Radiologists should not
conduct. To safeguard the public and
enter into an agreement that prohibits
the profession against physicians
the provision of medically necessary
deficient in moral character or
care or that requires care at below
professional competence, radiologists
acceptable standards.
are expected to report any perceived
illegal or unethical conduct of medical 9. Misleading billing arrangements.
professionals to the appropriate Radiologists should not participate in
governing body. billing arrangements that mislead
patients or payers concerning the fees
3. Report signature. Radiologists should
charged.
not sign a report or claim attribution of
an imaging study interpretation that 10. Expert medical testimony. Radiologists
was rendered by another physician, should exercise extreme caution to
making the reader of a report believe ensure that the testimony provided is
that the signing radiologist was the nonpartisan, scientifically correct, and
interpreter. clinically accurate. Compensation that is
contingent upon the outcome of
4. Participation in quality and safety
litigation is unacceptable.
activities. Radiologists who actively
interpret images should participate in 11. Research integrity. Radiologic research
quality assurance, technology must be performed with integrity and
assessment, utilization review, and be honestly reported.

2025 Noninterpretive Skills Study Guide 7

 12. Plagiarism. Claiming others’ intellectual
property as one’s own is unethical. This
includes plagiarism or the use of others’
work without attribution.
13. Misleading publicizing. Radiologists
should not publicize themselves
through any medium or forum of public
communication in an untruthful,
misleading, or deceptive manner.

References
1. American Board of Internal Medicine
Foundation. Medical Professionalism in the
New Millennium: The Physician Charter.
American Board of Internal Medicine
Foundation Website. http://
abimfoundation.org/what-we-do/medical-
professionalism-and-the-physician-charter/
physician-charter. Accessed October 1, 2016.
2. American College of Radiology. Code of
Ethics. American College of Radiology
Website. https:// www.acr.org/Member-
Resources/Commissions-
Committees/Ethics. Accessed June 13, 2018.

2025 Noninterpretive Skills Study Guide 8

Chapter 2: Core Concepts of Quality and Safety

2.1 Core Concepts of Quality “quality” is the patient. Those who wish to
provide quality care must understand and seek
2.1.1 Introduction to Quality
to achieve consistent excellence from the
Merriam-Webster defines quality as “a high perspective of the patient—which may differ
level of value or excellence.” The Institute of from that of the provider.
Medicine has defined quality of care as “the
Fourth, the goal is to consistently achieve
degree to which health services for individuals
desired health outcomes using methods that are
and populations increase the likelihood of
consistent with current professional
desired health outcomes and are consistent
knowledge. Achieving excellent outcomes on a
with current professional knowledge.” As it
consistent basis depends on consistency in the
relates to diagnostic imaging and image-guided
methods, or processes, that are used to achieve
treatment, quality can be considered to be “the
those outcomes. Therefore, a major goal of
extent to which the right procedure is done in
quality is that of decreasing unnecessary
the right way, at the right time, and the correct
variation, both in processes and outcomes. In a
interpretation is accurately and quickly
practice with multiple professionals, this
communicated to the patient and referring
generally requires those professionals to
physician. The goals are to maximize the
collaborate in developing and adhering to
likelihood of desired health outcomes and to
practice standards based on the evidence.
satisfy the patient.”
2.1.2 Quality as a Discipline
Several important concepts are connected to
these statements. Achieving consistent excellence in processes
and outcomes is challenging in healthcare,
First, quality has two important dimensions:
including in radiology. However, healthcare is
excellence and consistency. It is not enough to
by no means the only field in which consistent
provide excellent care; it must be done on a
excellence is desired. Over the past century,
consistent basis. Lack of consistency is a marker
“quality” has emerged as its own discipline of
of poor quality.
study and practice, with a set of broadly
Second, performance must be monitored to applicable definitions, principles, and tools.
ensure consistent quality. It is unlikely for an
Quality control (QC) refers to measuring and
organization to achieve consistent excellent
testing elements of performance to ensure that
performance in the absence of performance
standards are met and correcting instances of
standards or measurements.
poor quality. An example of a QC activity is
Third, the goals are twofold: 1) maximize the when a radiologist reviews and corrects errors
likelihood of health outcomes desired by the in a radiology report before finalizing it.
patient and 2) satisfy the patient. In other
Quality assurance (QA) refers to a process for
words, optimizing health outcomes and patient
monitoring and ensuring performance quality
experience are both important goals of
in an organization. This includes QC activities,
healthcare. Furthermore, while excellence may
but also refers to strategies designed to prevent
be a subjective term, the ultimate arbiter of
instances of poor quality. An example of a QA

2025 Noninterpretive Skills Study Guide 9

activity is the use of standardized report Quality methods and philosophies have
templates to minimize errors in reporting evolved in several other important ways in the
accompanied by verification of appropriate use past several decades:
with audit-based performance metrics.
• Rather than being solely the purview of
Quality improvement (QI) refers to activities a “quality department,” quality has
designed to improve performance quality in an come to be recognized as the
organization in a systematic and sustainable responsibility of everyone in the
way. This requires a deliberate effort within an organization—especially organizational
organization to agree on a measurable leaders.
performance objective, measure the relevant
• The focus has shifted from detecting
performance, understand the causes of poor
and correcting errors that have already
performance, develop and implement strategies
occurred to improving processes and
to improve performance, and ensure that those
systems to prevent errors from
strategies are embedded in the organization
happening or from causing harm.
such that performance will not relapse. An
example of QI is a project whereby radiologists • Frontline staff are increasingly engaged
agree to improve consistency in reporting using to help improve processes.
standardized radiology report templates, • The value of making errors visible
implement those templates, monitor radiology rather than quietly fixing them without
reports and make necessary adjustments, and sharing them with the staff is
ensure that consistency is maintained through increasingly recognized. Exposing
feedback and accountability. errors allows them to be more easily
QC is generally considered to be the most basic detected so they can be corrected and
level of quality-related activities in an their causes addressed.
organization. QA is more comprehensive than 2.1.3 2001 Institute of Medicine Report,
QC and is required to maintain consistently Crossing the Quality Chasm
high performance levels in an organization.
In 2001, the Institute of Medicine (IOM)
However, QA typically is designed to maintain
published a report entitled, “Crossing the
rather than improve performance, implying
Quality Chasm: A New Health System for the
that quality was presumed to be adequate in
21st Century.” In this report, the IOM
the first place. QI, on the other hand, assumes
committee members maintained that all
that quality is not as good as it could be and
healthcare constituencies, including
employs strategies to successfully improve
policymakers, purchasers, regulators, health
quality through a variety of means, including
professionals, health- care trustees and
changes in processes, systems, and even
management, and consumers, should commit
organizational structure. As organizations’
to a shared explicit purpose to continually
focus has transitioned in recent decades from
reduce the burden of illness, injury, and
seeking to maintain the status quo to seeking to
disability, and improve the health and
constantly improve performance, the field of
functioning of the people of the United States.
quality has transitioned from relying solely on a
QA approach to one of continuous quality The committee asserted that healthcare should
improvement (CQI). be:

2025 Noninterpretive Skills Study Guide 10

 • Safe—avoiding injuries to patients from and assimilate scientific evidence, and
the care that is intended to help them. improve the practice of medicine.

• Effective—providing services based on • Patient Care and Procedural Skills: Provide

scientific knowledge to all who can care that is compassionate, appropriate,
benefit and refraining from providing and effective treatment for health
services to those not likely to benefit problems and promote health.
(avoiding underuse and overuse). • Systems-based Practice: Demonstrate
• Patient-centered—providing care that is awareness of and responsibility to the
respectful of and responsive to larger context and systems of
individual patient preferences, needs, healthcare. Be able to call on system
and values and ensuring that patient resources to provide optimal care (e.g.,
values guide all clinical decisions. coordinating care across sites or serving
as the primary case manager when care
• Timely—reducing waits and potentially
involves multiple specialties,
harmful delays for both those who
professions, or sites).
receive and those who give care.
• Medical Knowledge: Demonstrate
• Efficient—avoiding waste, in particular
knowledge about established and
waste of equipment, supplies, ideas, and
evolving biomedical, clinical, and
energy.
cognitive sciences and their application
• Equitable—providing care that does not in patient care.
vary in quality because of personal
• Interpersonal and Communication Skills:
characteristics.
Demonstrate skills that result in
Since its publication, the IOM “Chasm” report, effective information exchange and
which was itself a follow-up to a 2000 IOM teaming with patients, their families,
report on medical error, has provided a road and professional associates (e.g.,
map for individuals and organizations in fostering a therapeutic relationship that
healthcare to focus their improvement efforts. is ethically sound; using effective
listening skills with nonverbal and
2.1.4 Core Competencies of the ABMS and
verbal communication; and working
ACGME
both as a team member and, at times, as
To encourage active physician participation in a leader).
advancing the goals of continuous
• Professionalism: Demonstrate a
improvement, in 1999 the Accreditation Council
commitment to carrying out
for Graduate Medical Education (ACGME) and
professional responsibilities, adhering to
the American Board of Medical Specialties
ethical principles, and being sensitive to
(ABMS), which is composed of subspecialty
diverse patient populations.
boards including the American Board of
Radiology, described six core competencies that By establishing this set of competencies, the
all physicians should attain. ACGME and ABMS assert that the skills
necessary to effectively practice medicine in a
• Practice-based Learning and Improvement:
modern complex healthcare environment
Show an ability to investigate and
extend beyond the traditional domains of
evaluate patient care practices, appraise

2025 Noninterpretive Skills Study Guide 11

medical knowledge and individual practice. It fundamental factors contributing to the errors,
is not enough for professionals to gain adequate including the following: 1) the decentralized
knowledge; they must also continuously nature of the healthcare delivery system (or
improve their knowledge and practice for the “nonsystem,” as the report calls it); 2) the
duration of their careers. They must be not only failure of licensing systems to focus on errors;
technically competent, but also compassionate 3) the impediment of the liability system to
and ethical. They must practice effectively not identify errors; and 4) the failure of third- party
only as individuals, but also as members of providers to provide financial incentive to
teams, organizations, and systems of care. improve safety.
Organizations and leaders who are responsible
The report authors emphasized that most errors
for certifying competence of practitioners must
are multifactorial; most errors can be attributed
demonstrate adequacy of the professional’s
to unsafe systems and processes of care as well
competence in all domains.
as to human error. Therefore, the only strategy
to decrease medical errors that is likely to be
both successful and sustainable in the long run
2.2 Core Concepts of Safety
is to design safety into systems and processes of
2.2.1 2000 Institute of Medicine Report, To Err care. Blaming and “rooting out the bad apples,”
is Human the authors contended, is not a viable strategy
In 1998, the National Academy of Sciences’ to decrease error.
Institute of Medicine (IOM) initiated the 2.2.2 2015 Institute of Medicine Report,
Quality of Health Care in America project to Improving Diagnosis in Health Care
develop a strategy that would result in
In 2015, the IOM issued what it considered to
improved quality of care in the United States.
be a follow-up report to its 2000 report on
To Err is Human: Building a Safer Health
medical error, this time focusing on diagnostic
System, published in 2000, was the first in a
error. In this report, Improving Diagnosis in
series of reports arising from this project. The
Health Care, the IOM committee defined
report’s findings that between 44,000 and
diagnostic error as “the failure to establish an
98,000 in-hospital deaths per year were
accurate and timely explanation of the patient’s
attributable to medical errors made national
health problem(s) or (b) communicate that
headlines, including a suggestion that an
explanation to the patient.” The definition is
epidemic of death from medical errors
purposely patient-focused because, according
exceeded that from motor vehicle accidents,
to the report, patients are considered to be key
breast cancer, or AIDS. The report projected
team members in the collaborative efforts
total societal costs of medical errors to be
required to prevent diagnostic error.
between $17 billion and $29 billion.
Quickly establishing a correct diagnosis is
The report defined medical error as the failure
critical to the provision of safe and effective
of a planned action to be completed as intended
patient care. The problem of diagnostic error
or the use of a wrong plan to achieve an aim,
tends to be underappreciated, for several
with the highest risk for errors occurring in
reasons. Data on diagnostic error are sparse,
high-acuity environments such as the intensive
few reliable measures exist, and often the error
care unit, operating room, and emergency
is identified only in retrospect. The best
department. The report identified several
estimates indicate that nearly all Americans will

2025 Noninterpretive Skills Study Guide 12

likely experience a meaningful diagnostic error 4. Develop and deploy organizational
in their lifetimes. A poll commissioned by the approaches to identify, learn from, and
National Patient Safety Foundation in 1997 reduce diagnostic errors and near
found that approximately one in six of those misses in clinical practice.
surveyed had experience with diagnostic error,
5. Establish a work system and culture that
either personally or through a close friend or
supports the diagnostic process and
relative.
improvements in performance. This
On average, 10% of postmortem exams were may include redesigning payment
associated with diagnostic errors that might structures since fee for service (FFS)
have affected patient outcomes. The report payments lack incentives to coordinate
authors maintained that reducing diagnostic care among team members, such as
error should be a key component of quality communication among treating
improvement efforts by healthcare clinicians, pathologists, and radiologists
organizations. about diagnostic test ordering,
interpretation, and subsequent decision
Similar to the 2000 IOM report, this report
making.
called for objective, nonpunitive efforts to
understand error and to improve systems and 6. Develop a reporting environment and
processes accordingly. This includes learning medical liability system that facilitates
from both errors and near misses on one end of improvement.
the spectrum and from exemplary accurate and
7. Design a payment and care delivery
timely diagnoses on the other end. The report
environment that supports the
authors viewed the diagnostic process as a
diagnostic process. Specifically,
collaborative activity, often between numerous
oversight bodies should require that
professionals and professional groups.
healthcare organizations have programs
Therefore, improving diagnosis often requires
in place to monitor the diagnostic
collaborative efforts between professionals to
process and identify, learn from, and
understand error and improve performance.
reduce diagnostic errors and near
The report authors made eight specific misses in a timely fashion.
recommendations for improvement in the
8. Provide dedicated funding for research
diagnostic processes:
on the diagnostic process and diagnostic
1. Facilitate more effective teamwork errors.
among healthcare professionals,
With respect to radiology, the 2015 IOM report
patients, and their families. Radiologists
identified failures in communication as being a
and pathologists are an integral part of
significant contributor to diagnostic error. The
the diagnostic team.
report authors made several recommendations
2. Enhance healthcare professional for IT professionals and organizational leaders
education and training in the diagnostic to improve communication, including the
process. following:
3. Ensure that health information • Standardize communication policies
technologies support patients and and definitions across networked
healthcare professionals. organizations

2025 Noninterpretive Skills Study Guide 13

 • Ensure clear identification of the Multiple brands of defibrillators exist that differ
patient’s care team to facilitate contact in physical appearance as well as functionality;
by the radiology team a typical hospital may have many different
models scattered around the building,
• Implement effective results
sometimes even on the same unit.
management and tracking processes
Human Factors Engineering
• Develop shared quality and reporting
metrics Human factors engineering as a discipline
attempts to identify and address such problems
2.2.3 Human Factors
in a systematic way. It takes into account
Background human strengths and limitations in the design
of interactive systems that involve people,
An obstetric nurse connects a bag of pain
equipment, technology, and work
medication intended for an epidural catheter to
environments to ensure safety, effectiveness,
the mother’s intravenous (IV) line, resulting in
and ease of use. A human factors engineer
a fatal cardiac arrest. Newborns in a neonatal
examines a particular activity in terms of its
intensive care unit are given full-dose heparin
component tasks and then assesses the human
instead of low-dose flushes, leading to three
physical, mental and skill demands in the
deaths from intracranial bleeding. An elderly
context of team dynamics, work environment
man experiences cardiac arrest while
(e.g., adequate lighting, limited noise, or other
hospitalized, but when the code blue team
distractions), and device design required to
arrives, the team is unable to administer a
optimally perform a task.
potentially life-saving shock because the
defibrillator pads cannot be connected to the In essence, human factors engineering focuses
defibrillator itself. on how systems work in actual practice, with
real—and fallible—human beings at the
Busy healthcare workers rely on equipment to
controls. It attempts to design systems that
carry out life-saving interventions with the
optimize safety and minimize the risk of error
underlying assumption that technology will
in complex environments.
improve outcomes.
Human factors engineering has long been used
But as these examples illustrate, the interaction
to improve safety in many industries, including
between workers, equipment, and the
aviation and nuclear power. Its application to
environment can actually increase the risk of
healthcare is relatively recent; pioneering
consequential errors. Each of these safety
studies of human factors in anesthesia were
hazards ultimately was attributed to a relatively
integral to the redesign of anesthesia
simple, yet overlooked, problem with system
equipment, significantly reducing the risk of
design.
injury or death in the operating room.
The bag of epidural anesthetic was similar in
Standardization
size and shape to IV medication bags, and,
crucially, the same catheter could access both Human factors engineering asserts that
types of bags. Full-dose and prophylactic-dose equipment and processes should be
heparin vials appeared virtually identical, and standardized whenever possible to increase
both concentrations were routinely stocked in reliability, improve information flow, and
automated dispensers at the point of care. minimize cross-training needs. Standardizing

2025 Noninterpretive Skills Study Guide 14

equipment across clinical settings is one basic errors.
example, but standardized processes are
Many healthcare organizations are attempting
increasingly recognized as a requirement for
to adopt high-reliability behaviors and
safety. The use of checklists as a means of
organizational strategies to reduce medical
ensuring that safety steps are performed, and
errors for their patients.
performed in the correct order, has its roots in
human factors engineering principles. According to the authors of the concept, HROs
Establishing an agreed- upon, standardized maintain resilience through stressful situations
approach for the basic elements of a procedure by both anticipating unexpected events and
allows team members to identify when containing their impact when they occur.
unintended variances from that approach occur Anticipation has three elements: preoccupation
(which may represent errors) and frees the team with failure, reluctance to simplify, and sensitivity
members to better focus on the unique aspects to operations. Containment has two elements:
of the case. commitment to resilience and deference to expertise.
These can be described as follows:
Communication
Anticipation
Effective communication is a critical aspect of
quality and safety in any complex environment. 1. Preoccupation with failure. Members of
Communication can be defined as the the organization recognize that even
meaningful exchange of information between minor lapses can have severe
individuals or groups of individuals; it is often consequences and tend to be
bidirectional or multidirectional and is deliberately watchful for clues that
successful when it results in shared indicate trouble. The organizations have
understanding of meaning. Communication processes in place to enable individuals,
consists of two major parts: 1) conveyance— teams, and systems to quickly detect
transmission of information from a sender to a and respond to potential threats before
receiver, and 2) convergence—verification, they result in harm.
discussion, and clarification until both parties 2. Reluctance to simplify. When problems
recognize that they mutually agree (or fail to arise, rather than accept simple
agree) on the meaning of the information. explanations, individuals are expected
Convergence activities are especially critical to dig deeper to understand the source
when information is ambiguous or when the of the problem.
negative impact of a miscommunication would
3. Sensitivity to operations. Members of
be severe.
the organization—especially the
High Reliability Organization (HRO) leaders—continuously understand the
In modern medicine, care delivery is frequently messy reality of the details of what is
performed in a high complexity setting. A so- actually happening in the place of work
called “high reliability organization (HRO)” is rather than what is supposed to be
an organization that, despite operating in a happening and respond accordingly.
high-stress, high-risk, complex environment, Containment
continually manages its environment
1. Commitment to resilience. It is
mindfully, adopting a constant state of
assumed that unexpected trouble is both
vigilance that results in the fewest number of

2025 Noninterpretive Skills Study Guide 15

 ubiquitous and unpredictable. HROs make it hard to perform the wrong action (i.e.,
recognize that they can never fully forcing functions, such as a microwave that
anticipate each unexpected event, so cannot be operated with the door open) and
they empower individuals to adjust and enablers that make it easy to perform the right
innovate as necessary and then seek to action (i.e., affordances, such as installing a
learn from those situations. door handle for pulling and a plate for
pushing). Rules- and knowledge-based errors
2. Deference to expertise. No one
tend to be amenable to increased supervision,
individual ever knows everything about
additional training and coaching, deliberate
any situation. People with greater
practice, and intelligent decision support.
authority often have less useful
knowledge about a situation than those Note that additional training is generally less
with lesser authority. HROs overcome effective for skill-based errors, and behavior
the dangers of hierarchy by enabling shaping constraints are less effective for rules-
leaders to defer to the relevant expertise, or knowledge-based mistakes. For example, a
regardless of its source, while radiologist who accidentally dictates “100 mg”
preserving the organizational structure. instead of “100 μg” is unlikely to benefit from
an educational course on units of measure in
2.2.4 Human Error
the metric system. Conversely, a simple clinical
People are prone to error, but not all errors are decision-support rule that forces a physician to
identical. order ultrasonography when he or she thinks
A commonly used human error classification that magnetic resonance imaging is warranted
scheme is the “skill-rule-knowledge” (SRK) is more likely to be ignored and thus less likely
model. This model refers to the cognitive mode to be successful than education and consensus-
in which the individual is operating when he or building efforts. Thus, in learning from an
she commits an error. Actions that are largely error, it is important to determine the cognitive
performed automatically, requiring little mode in which the individual was operating at
conscious attention, are considered skill-based the time.
actions, such as tying one’s shoes or driving on 2.2.5 Culture of Safety
the open freeway. Actions that require an
Background
intermediate level of attention are considered
rules-based actions, such as deciding which The concept of safety culture originated in
clothes to wear or when to proceed at a four- studies of high reliability organizations. High
way stop. Actions that require a high level of reliability organizations maintain a
concentration, usually in the setting of commitment to safety at all levels, from
situations that are new to the individual, are frontline providers to managers and executives.
knowledge-based actions, such as playing a According to the Agency for Healthcare
sport for the first time or driving in poor Research and Quality (AHRQ), this
visibility conditions in an unfamiliar city. commitment establishes a “culture of safety”
that encompasses the following key features:
Appropriate strategies for ensuring safety in
the face of human error depend on the type of • Acknowledgment of the high-risk
error committed. Skill-based errors tend to be nature of an organization’s activities
amenable to behavior- shaping constraints that and the determination to achieve

2025 Noninterpretive Skills Study Guide 16

 consistently safe operations Just Culture
• A blame-free environment where The traditional culture of individual blame,
individuals are able to report errors or which still dominates some healthcare
near misses without fear of reprimand organizations, impairs the advancement of a
or punishment safety culture. However, while blame is
generally an undesirable approach to safety,
• Encouragement of collaboration across
individuals need to be held accountable for
ranks and disciplines to seek solutions
their actions to a certain degree. In an effort to
to patient safety problems
reconcile the need for reducing a focus on
• Organizational commitment of blame and maintaining individual
resources to address safety concerns accountability, the concept of “just culture” was
Studies have documented considerable proposed by David Marx. The just culture
variation in perceptions of safety culture across model distinguishes between human error (e.g.,
organizations and job descriptions. Historically, slips), at-risk behavior (e.g., taking shortcuts),
nurses have often complained of the lack of a and reckless behavior (e.g., flaunting firmly
blame-free environment and providers at all established safety rules). In this model, the
levels have noted problems with organizational response to an error or near miss is predicated
commitment to establishing a culture of safety. on the type of behavior associated with the
The underlying reasons for the underdeveloped error, not the outcome or severity of the event.
healthcare safety culture include poor For example, reckless behavior, in which firmly
teamwork and communication, a “culture of established safety norms are willfully ignored,
low expectations,” and the presence of steep such as a physician who refuses to perform a
authority gradients. time out before surgery, may merit firm—
Authority Gradient possibly punitive—action, even if no patients
were harmed. In contrast, a person who makes
In an organization with steep authority
an innocent human error, even if this error
gradients, especially where there is fear of
resulted in significant patient harm, would be
punishment for errors, quality and safety
consoled since human errors are considered to
problems are rarely reported to senior
be inevitable and not necessarily the result of
leadership. In this way, such authority
negligence. In the middle ground, those
gradients not only undermine the safety
persons who engage in at-risk behavior— e.g.,
culture, but increase the difficulty of accurately
workarounds of convenience, such as failing to
measuring error rates.
communicate critical results, that could subvert
Measuring and Achieving a Culture of Safety established safety precautions—probably
underestimate the risks of their actions. These
Perceptions by the staff of poor safety culture
persons are counseled or coached in the Just
have been linked to increased error rates. Safety
Culture Model (Table 2.1).
culture can be measured by surveys of
providers at all levels. Available validated A safety coach or champion is a person in the
surveys include the AHRQ’s Patient Safety organization who takes ownership of the
Culture Surveys and the Safety Attitudes processes and fosters the creation and
Questionnaire. maintenance of the safety culture, including
oversight of safety-reporting systems whereby

2025 Noninterpretive Skills Study Guide 17

safety incidents and near-miss events are The term “second victim” has been coined for a
reported and archived. In a safety-reporting healthcare worker who is traumatized by an
system, the primary focus is on the patient, the error or adverse patient event in which they
event, and the processes and systems to were involved.
identify opportunities for sustainable
These individuals often feel an intense sense of
improvement. The individual who made the
guilt, sorrow, and anxiety, and may even
error should not be the focus of the
exhibit signs similar to post-traumatic stress
investigation, as long as the individual was not
disorder. Many hospitals have begun to
acting recklessly. In other words, the reporting
develop internal programs to identify, console,
system should not be used as a means of
and advocate on behalf of such individuals.
instigating punitive action.

Three Manageable Behaviors of the Just Culture Model

Behavior or event Human Error At-risk Behavior Reckless Behavior
Definition A product of our current A choice where the risk A conscious disregard
system design and our is believed to be for a substantial and
behavioral choices insignificant or justified unjustifiable risk
Management Strategies • Modify available • Counsel individual • Remediate or remove
choices • Better incentivize from the environment
• Change processes/ correct behavior • Take punitive action as
workflows • Modify processes, warranted
• Improve training training, etc. as needed
programs
• Redesign system or
facility
Recommended Console Coach Punish/Sanction
approach to the
individual
Table 2.1 Outline of the Just Culture Model. Adapted from Marx 2009.

2025 Noninterpretive Skills Study Guide 18

References
1. Balogh EP, Miller BT, Ball JR, eds. Board on 8. Larson DB, Froehle CM, Johnson ND,
Health Care Services, Institute of Medicine. Towbin AJ. Communication in diagnostic
Improving diagnosis in health care. radiology: meeting the challenges of
Washington, DC: The National Academy of complexity. AJR Am J Roentgenol
Sciences, The National Academies Press, 2014;203(5):957-964.
2015. 9. Larson DB, Kruskal JB, Krecke KN,
2. Committee on Quality of Health Care in Donnelly LF. Key concepts of patient safety
America; for the Institute of Medicine. in radiology. Radiographics 2015;35(6):1677-
Crossing the quality chasm: a new health 1693.
system for the 21st century. Washington, 10. Marx D. Console, coach, or punish? In:
DC: National Academy Press, 2001. Whack-
3. Hillman BJ, Amis ES Jr, Neiman HL,
a-mole: the price we pay for expecting
FORUM participants. The future quality
perfection. Plano, TX: By Your Side Studios,
and safety of medical imaging: proceedings 2009;47–55.
of the third annual ACR FORUM. J Am Coll
Radiol 2004;1(1):33-39. 11. A Trusted Credential: Based on Core
Competencies. American Board of Medical
4. Kelly AM, Cronin P. Practical approaches to
Specialties Website. www.abms.org/board-
quality improvement for radiologists. certification/a-trusted-credential/based-on-
Radiographics 2015;35(6):1630-1642. core- competencies/. Accessed October 1,
5. Kohn LT, Corrigan JM, Donaldson MS, eds. 2016.
Committee on Quality of Health Care in
America,
Institute of Medicine. To err is human:
building a safer health system. Washington,
DC: National Academy Press, 2000.
6. Kruskal JB, Anderson S, Yam CS, Sosna J.
Strategies for establishing a comprehensive
quality and performance improvement
program in a radiology department.
Radiographics 2009;29(2):315-329.
7. Kruskal JB, Eisenberg R, Sosna J, Yam CS,
Kruskal JD, Boiselle PM. Quality initiatives:
Quality improvement in radiology: basic
principles and tools required to achieve
success. Radiographics 2011;31(6):1499-1509.

2025 Noninterpretive Skills Study Guide 19

Chapter 3: Practical Quality and Safety Applications in
Healthcare

3.1 Practical Quality Applications in anticipated in the near future. First-tier huddles
Healthcare are held within local units and involve all
frontline staff on service for the day. Unit
Quality improvement activities can be divided
leaders then attend huddles at a higher tier,
into two aspects: 1) frequent small
whose leaders in turn attend huddles at a
improvement efforts conducted in close
higher tier, up to the executive team. Huddles
association with the management of the day-to-
generally take place at a visibility board (often
day clinical operations and 2) dedicated
simply an organized white board), which tracks
improvement projects to address areas of
important elements of the daily management
performance that generally require more
huddles for all staff members to see.
focused improvement efforts.
Goal and Metrics Review
3.1.1 Daily Management Systems
Organizational goals help focus the members
A daily management system (DMS) provides a
on making tangible progress toward better
day- to-day operating framework for leaders to
fulfillment of the organization’s missions.
engage with staff to solve problems on a
Performance metrics enable members of the
continuous basis. The objective of the DMS is to
organization to objectively determine how well
facilitate communication and coordination
those goals are being met. Ideally such goals
within and across organizational units and
and metrics should be aligned with the stated
roles in the organization. For example, in a
values of the organization, including excellence
radiology department, a DMS allows for
in care, patient safety, patient and family
coordination and communication between 1)
experience, efficiency, etc. A brief review of
radiologists, technologists, nurses, medical
quantitative metrics at the huddle on a regular
assistants, IT professionals, administrators, etc.;
basis helps the organization make iterative
2) front line staff, managers, and leaders; and 3)
improvements to facilitate continued progress
the radiology department and other units such
toward the goals.
as the emergency department, inpatient units,
medical and surgical specialties, etc. Daily Readiness Assessment

A DMS can be implemented in a variety of A daily readiness assessment reviewed at the

ways to meet local organizational needs. huddle helps the staff be aware of the number
However, DMS programs tend to have a few and types of patients to be seen that day and to
core elements that help them achieve the determine whether they are prepared to
programs’ objectives. accommodate their needs. Topics that are
typically reviewed include 1) methods:
Tiered Huddles
ensuring that the proper protocols and plans
A huddle is a brief structured meeting are in place to accommodate patients, especially
occurring in an organizational unit in which those with special needs, 2) equipment:
participants review what has recently occurred, reviewing whether all of the equipment is
the current status of the unit, and what is operational and staff have appropriate training,

2025 Noninterpretive Skills Study Guide 20

3) supplies: ensuring that all needed supplies more amenable to dedicated improvement
are available for use, and 4) associates: ensuring projects. Several well-known improvement
that appropriate staff are in place to meet models exist, including Lean, Six Sigma, and
patient needs and that any staff shortages have the Model for Improvement. Each of these
been accommodated. models uses a similar approach to structuring
improvement projects, though framed in
Problem Management and Accountability Cycle
different ways. The following sections
Continuous problem solving is a critical
summarize the major steps that the models
element of the DMS. Staff are encouraged to
share.
identify problems at the daily huddle. Problems
are documented on the visibility board, along Identifying a Problem
with an “owner” of the problem and an
As it relates to improvement, the term
expected resolution date. Problems that are
“problem” can be interpreted two ways: 1)
more complex often are listed on a separate
something that is difficult to deal with, a source
board along with the owner of the problem, the
of trouble, worry, etc. and 2) something to be
date the issue was first identified, and a date on
worked out or solved, such as an arithmetic
which the owner is expected to make a progress
problem.
report.
The fact that the problem is a source of trouble
Regular Follow-up
is what drives the organization to decide to
The regular cadence of the daily huddles, along focus improvement in a specific area. Before
with the tracking of assignments on the visibility beginning the project, leaders should make sure
board, provides a mechanism to routinely follow that it addresses a problem that is of high
up on assignments. importance to the organization, so that it will
receive needed support when challenges arise.
This visibility and follow-up greatly increases
the likelihood that assignments will be Framing the problem as a challenge to be
completed or revised as needed. solved helps depersonalize the issue and turn it
into an opportunity for improvement. Clearly
Frequent Visits to the Workplace
defining the problem is the first step in solving
A core tenet of effective management is that one the problem, helping to ensure that the project
must see what is happening in the workplace to team remains focused and aligned as team
truly understand it. Managers and leaders are members evaluate causes and consider possible
encouraged to minimize the time spent in solutions.
closed-door meetings in favor of spending time
Forming a Team
where the work is done. When individuals visit
the workplace, they are expected to respectfully To effectively carry out the project, a dedicated
observe and ask questions to learn about the team is organized for a limited period of time
work; they should not give direction, solve and given the guidance, resources, instruction,
problems, or otherwise interfere with the work and authority needed to make process and
during this time. other organizational changes to improve
performance in a sustainable way. Project roles
3.1.2 Project-based Improvement Methods
typically include the following:
Problems that are too difficult to solve using
• Project Sponsor: This individual provides
routine daily problem-solving methods may be

2025 Noninterpretive Skills Study Guide 21

 organizational oversight and support, should avoid encroaching on the role of
removing barriers as they arise. The project leader or performing tasks of the
sponsor should have the organizational project participants.
authority to provide resources and
Assessing Current Performance
resolve interpersonal conflicts. Projects
may have more than one sponsor. Improvement project team members are
While sponsors may provide general expected to visit the workplace and spend at
guidance and suggestions, they least several hours quietly observing and taking
notes. Team members should respectfully ask
should be careful to avoid
questions to deeply understand the process:
overstepping their bounds and
what is done and why it is done that way. They
assuming the project leader’s role. should convene and discuss their observations,
• Project Leader: The project leader’s role is mapping out the process, and then revisit the
to direct and coordinate activities of the workplace to validate their observations. They
project to ensure its success. The leader should, to the extent possible, observe all steps
helps assemble the team, manage the in the process at different times of day and days
project, delegate and follow up on of the week.
assignments, report on progress, alert
Measuring Performance
the project sponsor when more help is
needed, and ensure the timely To be able to assess performance in an objective
completion of the project. Project leaders and repeatable fashion, team members should
should have strong organizational and develop performance measures. These may
leadership skills. include outcome measures, including those of end
outcomes such as morbidity, patient satisfaction,
• Project Participants: Participants should and costs, as well as those of intermediate
be selected from the areas targeted for outcomes, such as service times, error rates, and
improvement; each organizational unit supply utilization. In addition to outcomes
included in the process targeted for measures, process measures can be used such as
improvement must be represented on adherence to standard work, equipment
the team. It is generally more effective to utilization rates, and times for each process
select “front-line” staff who perform the step.
work on a daily basis rather than
supervisors, managers, or other After one or more quantitative measures are
organizational leaders. Participation established, performance should be tracked and
should be voluntary. monitored. Performance can be monitored with
a run chart, which displays data over time. The
• Project Coach: The project coach is an run chart should display the mean before the
expert in improvement methods who beginning of the project and at the end of the
advises and supports the team. The project, as well as the performance goal. An
coach helps guide the project leader and annotated run chart is a run chart that also
team, facilitates communication with the indicates the dates and the nature of
sponsor, and alerts organizational interventions implemented during the project
leaders when the project appears to be (Fig. 3.1).
veering off track. However, the coach

2025 Noninterpretive Skills Study Guide 22

 Figure 3.1 Exampleof an annotatedrun chart. Each pointrepresentsthe mean daily
examination completion time. Dates that interventions were implementedare plotted
on the chart and described in the key. The goal for this hypothetical project was to
decrease mean daily examination completion time from 120 minutes to 30 minutes.
Source: Larson and Mickelsen. AJR Am J Roentgenol 2015.

Establishing a Specific Goal time from 120 minutes to 30 minutes by July 1,

2018.”
The project team should establish a
performance goal (often referred to as an aim Identifying Causes of Problems
statement). A commonly used acronym to
After establishing a measure and a goal and
describe the attributes of the goal is “SMART,”
observing the process in detail, the project team
meaning that the goal should be specific,
should seek to discover and document the
measurable, achievable, relevant, and time-
causes of problems that negatively impact
bound. The goal should state the beginning
performance. A tool for documenting these
performance, the end performance, and the
causes is a cause-and-effect diagram, also known
date (i.e., “from what, to what, by when”). For
as a fishbone diagram (Fig. 3.2).
example, the goal might state, “Our goal is to
decrease mean daily examination completion

2025 Noninterpretive Skills Study Guide 23

 Figure 3.2. Cause-and-effect diagram or fishbone diagram. This diagram lists and
categorizes possible contributing causes to the problem of over-ordering of CT scans
in the emergency department (ED). Source: Kruskal et al. Radiographics 2011.

Prioritizing Problem-solving Efforts prioritized accordingly.

After possible causes of problems are Developing Solutions through Iterative Testing
documented, the frequency of those causes
After the problem has been thoroughly
should be measured in some way. Often this is
investigated, including likely causes, it is the
accomplished with a simple tally sheet, in
project team’s task to develop strategies to
which staff members document every time the
solve the problem by making process changes.
problem occurs over a period of time along
However, such changes are rarely successful in
with the cause for the occurrence. These can
the form in which they are originally conceived
then be plotted in a Pareto chart (Fig. 3.3),
and typically require multiple revisions before
which illustrates which causes occur most
they can be fully implemented. The process of
frequently. The Pareto principle, also known as
iteratively testing, refining, and validating
the “80/20 rule,” states that a few causes are
process changes is known as the Plan-Do-
usually responsible for the majority of the
Study-Act (PDSA) cycle.
problems. Problem-solving efforts can then be

2025 Noninterpretive Skills Study Guide 24

 Figure 3.3. Pareto chart. This chart illustrates which causes are most commonly responsible
for the problem. In this case, the team was seeking to identify the most common types of
unhelpful emergency department (ED) exams. Source: Kruskal et al. Radiographics 2011.

The PDSA cycle is essentially a restatement of try a different approach.

the scientific method. A synonym for a PDSA
Changes are tested on a larger scale only after
cycle is a planned test of change. A cycle starts
they have been proven successful on a smaller
with a hypothesis of how a process change will
scale. The final determination of whether the
lead to a desired outcome. The steps include
changes are effective in practice is if they result
developing a plan to test that hypothesis
in improved performance. Hence, it is critical to
(planning the test), testing the hypothesis
continuously monitor performance throughout
(doing the test), analyzing the data (studying
the life of an improvement project.
the results), and drawing actionable
conclusions and determining next steps (acting Improvement is generally most effective when
accordingly). multiple PDSA cycles are run in parallel or in
rapid succession. With each test, the
Because the effects of process changes are not
improvement team gains greater insight and
known in advance, initial changes are typically
knowledge of how specific changes impact
tested on as small a scale as possible and in a
outcomes—for better and for worse. Only after
relatively protected environment. It is expected
the problems have been worked out and the
that many of these proposed changes will be
team is confident that the changes will result in
unsuccessful. For this reason, the team is wise
the desired improved outcomes are the changes
to generate a number of potential changes
fully implemented. Despite the fact that
through brainstorming. When a test of change
multiple PDSA cycles are needed for most
does not result in the desired outcome, the
successful improvement projects, if they are
project team may wish to modify the approach
executed well and kept as small and brief as
and test it again or abandon it altogether and

2025 Noninterpretive Skills Study Guide 25

possible, the process of testing, refining, and to be done by whom and by when, and
validating changes need not be protracted. following up on each task; 2) progress tracking:
keeping people apprised of project progress,
Sustaining the Improvement
reminding individuals as deadlines approach,
Without deliberate mechanisms to sustain and alerting appropriate individuals when
improvements, performance usually reverts to milestones are missed; 3) conducting effective
the initial state. Strategies to increase the meetings; and 4) avoiding mistakes common to
likelihood that results will be sustained include quality improvement.
1) establishing regular measurement and
feedback, 2) using handoffs to enforce
standards by ensuring that all staff expect the References
same standard, 3) establishing the practice of
1. Donnelly LF. Daily management systems in
stopping the process and summoning
medicine. Radiographics 2014;34(2):549-555.
immediate supervisors whenever a problem is
encountered, 4) embedding checks into the 2. Kruskal JB, Eisenberg R, Sosna J, Yam CS,
process, and 5) using high-reliability solutions. Kruskal JD, Boiselle PM. Quality initiatives:
Quality improvement in radiology: basic
High-reliability Solutions: Process changes may
principles and tools required to achieve
take many forms, including education and
success. Radiographics 2011;31(6):1499-1509.
feedback, standardization of procedures, and
infrastructure and system changes. In general, 3. Kruskal JB, Reedy A, Pascal L, Rosen MP,
processes that rely on education and feedback Boiselle PM. Quality initiatives: lean
tend to result in lower consistency in outcome, approach to improving performance and
or reliability, than those that rely on efficiency in a radiology department.
standardization of procedures, which in turn Radiographics 2012;32(2):573-587.
tend to result in lower consistency of outcome 4. Larson DB, Kruskal JB, Krecke KN,
than those that rely on changes to infrastructure Donnelly LF. Key concepts of patient safety
and organizational culture. As a general rule, in radiology. Radiographics 2015;35(6):1677-
high-reliability process changes are more 1693.
effective and require less effort by the process
owner to sustain than low-reliability solutions. 5. Larson DB, Mickelsen LJ. Project
management for quality improvement in
QI Project Management radiology. AJR Am J Roentgenol
A project is defined as “a temporary group 2015;205(5):W470-W477.
activity, designed to produce a unique product,
service, or result.” Project management is the
“application of knowledge, skills, and
techniques to execute projects effectively and
efficiently.” Effective project management
techniques bring order to what can otherwise
be a chaotic process, to help ensure that projects
meet their objectives.
Examples include 1) task management: defining
each task, clearly setting expectations of what is

2025 Noninterpretive Skills Study Guide 26

3.2 Practical Safety Applications in administration of medications to reduce
Healthcare anxiety, during which the patient
responds to verbal commands. In this
3.2.1 Periprocedural Care state, cognitive function and
Patient Identifiers coordination may be impaired, but
ventilatory and cardiovascular functions
Patient identification is critical to ensure that
are unaffected.
the right patient receives the right treatment,
medication, invasive or noninvasive procedure, 2. Moderate Sedation/Analgesia. A mildly
and blood products, as well as to reduce the depressed level of consciousness,
chance of unnecessary radiation exposure. At induced by the administration of
least two patient identifiers should be used pharmacologic agents, in which the
before every procedure. Identifiers can include patient retains a continuous and
patient name, assigned identification number, independent ability to maintain
telephone number, or other person-specific protective reflexes and a patent airway
identifier (e.g., date of birth, government-issued and to be aroused by physical or verbal
photo identification, and last four digits of the stimulation.
social security number). Transient factors such 3. Deep Sedation/Analgesia. A drug-
as patient’s location or room number cannot be induced depression of consciousness
used. Sources of identifiers may include the during which the patient cannot be
patient, a relative, a guardian, a domestic easily aroused but responds
partner, or a healthcare provider who has purposefully after repeated or painful
previously identified the patient. In the case of stimulation. Independent ventilatory
a discrepancy between identifiers, the function may be impaired. The patient
practitioner should stop and seek additional may require assistance in maintaining a
information to confirm the identity before patent airway. Cardiovascular function
proceeding. is usually maintained.
Patient Assessment 4. General Anesthesia. A controlled state
Before sedation is initiated, a patient must be of unconsciousness in which there is a
assessed and approved for sedation. Recent oral complete loss of protective reflexes,
intake, recent illness, pulmonary status including the ability to maintain a
(including upper airway), cardiac status, patent airway independently and to
baseline vital signs, level of consciousness, respond appropriately to painful
pulse oximetry, capnography (if available), and stimulation.
electrocardiography (when applicable) should It is important to recognize that these “levels”
be obtained and documented. are actually a continuum. Patients may rapidly
Sedation move between the levels and may reach a
deeper level of sedation than desired. Sedation
The Joint Commission and the American
may result in the loss of protective reflexes.
Society of Anesthesiologists have defined four
Thus, all sedated patients require monitoring
levels of sedation, analgesia, and anesthesia:
regardless of the intended level of sedation.
1. Minimal Sedation or Anxiolysis. A
Patients who are candidates for sedation by a
drug- induced state, created by the

2025 Noninterpretive Skills Study Guide 27

non- anesthesia provider such as a radiologist must have intravenous access. Continuous
must be screened to determine if they have risk monitoring should include, at a minimum, level
factors that may increase the likelihood of an of consciousness, respiratory rate, pulse
adverse outcome. Such risk factors include, but oximetry, blood pressure (as indicated), heart
are not limited to, congenital or acquired rate, and cardiac rhythm. Similar monitoring is
abnormalities of the airway, liver failure, lung needed in the recovery period from sedation.
disease, congestive heart failure, symptomatic The supervising physician should have
brain stem dysfunction, apnea or hypotonia, a sufficient knowledge of the pharmacology,
history of adverse reaction to sedating indications, and contraindications for the use of
medications, morbid obesity, and severe sedative agents, including the use of reversal
gastroesophageal reflux. agents. A key point related to reversal agents is
that their duration of effect may be shorter than
The patient’s American Society of
that of the sedating agent, leading to a risk of
Anesthesiologists (ASA) Physical Status
relapse into a deeper level of sedation. It is
Classification should also be assessed. This is a
recommended that consciousness and vital
six-level classification as follows:
signs return to acceptable levels and remain at
• Class I - A normal healthy patient those levels for a period of two hours from the
• Class II - A patient with mild systemic time the reversal agent was administered before
disease monitoring ends and the patient is discharged.

• Class III - A patient with severe Informed Consent

systemic disease Informed consent is required for invasive
• Class IV - A patient with severe image- guided procedures. Apart from legal or
systemic disease that is a constant threat regulatory requirements, patients have the right
to life to be informed about the procedures they
undergo and may request to speak with a
• Class V - A moribund patient who is not
radiologist even when local policy does not
expected to survive without the
require the radiologist to initiate an informed
operation
consent process.
• Class VI - A declared brain-dead patient
Despite the fact that a consent form is often
whose organs are being removed for
used to document the discussion, the ACR-SIR
donor purposes
Practice Parameter on Informed Consent for Image-
Patients in Classes III and IV or with other Guided Procedures states that “informed consent
significant risk factors may require a is a process and not the simple act of signing a
consultation with anesthesiology or the formal document.” Consent can also be
performance of sedation by an anesthesiologist documented by a note in the patient’s medical
or anesthetist. Patients in Class V should not be record, by a recording on videotape, or by
sedated by non-anesthesiologists. another similar permanent modality. Consent
should be obtained from the patient or the
When sedation is performed under the
patient’s legal representative by a physician or
supervision of a radiologist, there must be a
other healthcare provider performing the
separate qualified healthcare professional
procedure. The final responsibility for
whose primary focus is the monitoring,
answering the patient’s questions and
medicating, and care of the patient. The patient

2025 Noninterpretive Skills Study Guide 28

addressing any patient concerns rests with the issue of parental rights versus minors’ rights
physician performing or supervising the vary from state to state. States and courts have
procedure. never allowed children younger than 12 years
to make medical decisions and exercise self-
Elements of informed consent include 1) the
determination, whereas adolescents between
purpose and nature of the intended procedure,
ages 12 and 18 (or 19 in some states) experience
2) the method by which the procedure will be
a gradual transition to self- determination.
performed, 3) likely risks, complications, and
Factors that impact the determination of
expected benefits, 4) risks of not proceeding, 5)
adolescents’ rights include the following:
any reasonable alternatives to the proposed
procedure, and 6) the right to decline the 1. Legal determination of maturity, such
proposed procedure. An exception to these as married status, parenthood, self-
steps exists when a delay in treatment would sufficiency, or active duty in the armed
jeopardize the health of a patient who is unable services.
to provide informed consent (e.g., an
2. Evidence that the child is sufficiently
unconscious trauma patient for whom family
mature to make his or her own
has not yet been identified). Since the patient
decisions, such as age greater than 14
must be able to understand the consent process
years; evidence that the minor has the
for it to be valid, consent must be obtained
ability to understand the implications of
before procedure-related sedation is
treatment, including risks, benefits,
administered.
likely short- and long-term
When the patient is not able to give valid consequences, and alternatives; and
consent because of short-term or long-term evidence that the minor can make an
mental incapacity, whether from pain informed decision without coercion.
medications or otherwise, or when the patient
3. Conditions exempting parental
has not achieved the locally recognized age of
consent, such as seeking testing or
majority, consent should be obtained from the
treatment for sexually transmitted
patient’s appointed healthcare representative,
diseases, included HIV; seeking
legal guardian, or appropriate family member.
contraception, prenatal care, or abortion;
In emergency situations when the patient needs
or seeking mental health treatment,
immediate care, the patient’s predetermined
emergency care, or treatment of alcohol
wishes are not known or appropriately
or drug abuse after the age of 12 years.
documented, and consent cannot be obtained
from the patient’s representative, the physician Universal Protocol
may provide treatment or perform a procedure Universal protocol refers to the three-part
“to prevent serious disability or death or to process of conducting a preprocedure verification,
alleviate great pain or suffering.” marking the procedure site, and performing a
Minors’ Rights in Medical Decision Making Courts preprocedure time out. Note that site marking
in the United States have recognized that may be performed before completing the
children younger than 18 years deserve a voice preprocedure verification.
in determining their course of medical 1. Preprocedure verification. This is an
treatment if they show maturity and ongoing process of information
competence. However, rules that govern the gathering and confirmation before the

2025 Noninterpretive Skills Study Guide 29

 procedure. The purpose is to ensure that cases for which the catheter or
all relevant information and equipment instrument insertion site is not
are 1) available before the start of the predetermined (such as cardiac
procedure, 2) correctly labeled, catheterization), procedures on teeth,
identified, and matched to the patient’s and procedures on premature infants,
identifiers, and 3) reviewed and are for whom the mark may cause a
consistent with the expectations of the permanent tattoo.
procedure to be performed.
3. Preprocedure time out. A standardized
Preprocedural verification may occur at
time out should be conducted
more than one time and place before the
immediately before an invasive
procedure.
procedure is started or an incision is
2. Marking of the procedure site. At a made. The designated member of the
minimum, a procedure site should be team starts the time out. The time out
marked when there is more than one should involve the immediate members
possible location for the procedure and of the team, including the individual
when performing the procedure in a performing the procedure, anesthesia
different location could harm the providers, the circulating nurse, the
patient. If possible, the patient should be operating room technician, and other
involved in the site marking. The site active participants who will be present
must be marked by a licensed throughout the case. During the time
independent practitioner who will be out, all relevant members of the team
present when the procedure is actively communicate and at a
performed. In limited circumstances, minimum agree on the following:
site marking may be delegated to correct patient identity, correct site, and
medical residents, physician assistants procedure to be done. Documentation of
(PAs), or advanced practice registered the time out should be performed
nurses (APRNs), but ultimately the according to the organization’s policy.
licensed independent practitioner is
3.2.2 Hand Hygiene
accountable for the procedure, even
when delegating site marking. Hand hygiene refers to cleaning one’s hands by
using either handwashing (washing hands with
The mark should be made at or near the
soap and water), antiseptic hand wash,
procedure site, and should be
antiseptic hand rub (i.e., alcohol-based hand
sufficiently permanent to be visible after
sanitizer including foam or gel), or surgical
skin preparation and draping. It should
hand antisepsis.
also be unambiguous and used
consistently throughout the Alcohol-based hand sanitizers are the most
organization. An organization should effective products for reducing the number of
have written alternative processes for bacteria on the hands. When hands are not
situations such as procedures on visibly dirty, alcohol-based hand sanitizers are
mucosal surfaces or perineum, minimal the preferred method for cleaning one’s hands
access procedures treating a lateralized in the healthcare setting. Soap and water are
internal organ, interventional procedure recommended when hands are visibly dirty,
before eating, after using a restroom, or after

2025 Noninterpretive Skills Study Guide 30

known or suspected exposure to Clostridium sequence of events leading to the error, with the
difficile, norovirus, or Bacillus anthracis. goals of identifying how the event occurred
(active errors) and underlying conditions that
Hand hygiene should be performed 1) before
contributed to the event (latent conditions). It
eating, 2) before and after having direct contact
should be recognized that serious adverse
with a patient’s skin, 3) after contact with
events are almost never the result of a single
blood, body fluids or excretions, mucous
cause, and often are associated with numerous
membranes, nonintact skin, or wound
contributing factors. The RCA should culminate
dressings, 4) after contact with inanimate
in an analysis of issues that should be
objects in the immediate vicinity of the patient,
addressed to decrease the likelihood of
5) if hands will be moving from a
recurrence and a plan for addressing those
contaminated-body site to a clean- body site
issues, including a timeline and individual
during patient care, 6) after glove removal, and
responsibility.
7) after using a restroom. When hands are
cleaned with soap and water, the soap and In the setting of a serious adverse event,
water should cover all surfaces of the hands immediate interventions may be implemented
and fingers. When alcohol-based hand sanitizer to quickly reduce the risk of recurrence of a
is used, the product should cover all surfaces as similar error. However, such quickly generated
hands are rubbed together. Adequate cleansing solutions typically do not address the root
can be achieved in about 20 seconds via either cause and should only serve as a placeholder
route. until more reliable and sustainable solutions
can be developed, tested, and implemented.
3.2.3 Root Cause Analysis
Root cause analysis (RCA) is a structured
method used to analyze serious adverse events References
to decrease the likelihood of recurrence. The
goal of RCA is to identify both active errors 1. American College of Radiology, Society of
(errors occurring at the point of interface Interventional Radiology. ACR-SIR practice
between humans and a complex system) and parameter for sedation/analgesia. American
latent conditions (the hidden problems within College of Radiology, Society of
healthcare systems that increase the likelihood Interventional Radiology.
of an adverse event). For example, an active https://www.acr.org/-
error occurs when a nurse accidentally /media/ACR/Files/Practice-Parameters/sed-
administers a full dose of heparin rather than a analgesia.pdf. Accessed June 13, 2018.
heparin flush; an associated latent condition 2. Brook OR, Kruskal JB, Eisenberg RL, Larson
might be the fact that the two vials appear DB. Root cause analysis: learning from
virtually identical and both are routinely adverse safety events. Radiographics
stocked near each other in the same cabinet at 2015;35(6):1655-1667.
the point of care.
3. Centers for Disease Control and Prevention.
RCAs should generally begin with data Hand hygiene in healthcare settings.
collection to create an objective narrative of the Centers for Disease Control and Prevention
event based on a review of the medical record Website. http://www.cdc.
and interviews with people involved. A gov/handhygiene/providers/index.html.
multidisciplinary team should then analyze the

2025 Noninterpretive Skills Study Guide 31

 Accessed October 1, 2016.
4. Hickey K. Minors’ rights in medical decision
mak- ing. JONA’s Healthcare, Law, Ethics, and
Regulation 2007;9(3):100-104.
5. The Joint Commission. National patient
safety goals effective January 1, 2016. The
Joint Commission Website.
https://www.jointcommission.org/assets/1/6
/2016_NPSG_HAP.pdf. Accessed October 1,
2016.
6. The Joint Commission. Speak UP. The Joint
Commission Website.
www.jointcommission.org/as-
sets/1/18/UP_Poster1.PDF. Accessed
October 1, 2016.
7. Kohi MP, Fidelman N, Behr S, Taylor AG,
Kolli K, Conrad M, Hwang G, Weinstein S.
Periprocedural Patient Care. Radiographics
2015;35(6):1766-1778.
8. Weick KE, Sutcliffe KM. Managing the
unexpected: resilient performance in an age
of uncertainty. San Francisco, Calif: Jossey-
Bass, 2007.

2025 Noninterpretive Skills Study Guide 32

Chapter 4: Practical Safety Applications in Radiology
4.1 MR Safety emergency procedures are in place and trained
for, education is appropriate and completed,
Three unique magnetic fields in MRI, the static
among other responsibilities. The MRSE,
magnetic field (B0), time-varying
typically an MR physicist, is a resource for the
radiofrequency magnetic field (B1), and time-
MRMD and MRSOs, rendering expertise
varying gradient magnetic field (dB/dt) all
related to the safe use of MR equipment, and
contribute to specific MR safety challenges.
recommendations for appropriate scanning
Because the strong static magnetic field is
conditions for patients with implanted devices,
always on, the MR environment is associated
among other roles.
with unique safety issues. Safety must be
ensured for all in the MR environment, 4.1.1 Zoning and Screening
including patients, research subjects, MRI A key concept in MR safety is the conceptual
personnel, and visitors to the MR environment. division of the MR site into four zones, with
Greater risk can be presumed related to non- progressive monitoring and restriction of entry
MR personnel who do not regularly work in the into the higher numbered, more controlled
MR environment. This includes physicians and zones. These zones are defined as follows:
nurses who rarely enter the MR suite but may
do so in urgent situations related to acute Zone I: Access is unrestricted. This zone
patient decompensation. Improperly trained includes all areas that are freely accessible
and inadequately screened security and to the public. This is the area through which
cleaning personnel may unknowingly bring patients and others access the controlled
ferromagnetic materials into the MR MR environment.
environment. Patients’ family members may be Zone II: This is the interface between the
overlooked in screening programs. To address uncontrolled Zone I and the strictly
these and other issues, the American College of controlled Zones III and IV. Zone II may be
Radiology (ACR) Manual on MR Safety exists used to greet patients, obtain patient
in the form of a free online document which histories, and screen patients for MR safety
will be periodically updated. issues. Patients in Zone II should be under
Management of MR safety is now the supervision of MR personnel.
recommended to include 3 specific roles: a Zone III: This is the area where there is
designated physician MR Medical Director for potential danger of serious injury or death
MR safety (MRMD); MR safety officer (MRSO); from interaction between unscreened
and MR safety expert (MRSE). The MRMD people or ferromagnetic objects and the
assumes ultimate responsibility for a site’s magnetic field of the scanner. The scanner
operational MR safety and the safe execution of control room is typically in Zone III. Access
all MR examinations. They appoint MRSOs and to Zone III must be strictly restricted and
MRSEs, maintain MR safety policies and under the supervision of MR personnel,
procedures, and appropriately investigate any with physical restriction such as locks or
MR safety adverse events. The MRSO role, passkey systems.
typically filled by a technologist, ensures that
Zone IV: This is the MR scanner magnet
policies and procedures are followed,
room and therefore is the highest risk area.

2025 Noninterpretive Skills Study Guide 33

 This zone should be clearly demarcated and and implanted devices information in electronic
marked as potentially hazardous because of medical records. When an object or implant is
the strong magnetic field. Access to Zone IV identified, its MR safety potential should be
should be under the direct observation of assessed specific to the field strength of the
MR personnel. When a medical emergency magnet and specific factors such as RF
occurs, MR trained and certified personnel deposition (e.g., SAR, specific absorption rate).
should begin basic life support or CPR if Objects that are nonhazardous in all MR
required, while urgently moving the patient environments, such as a plastic tube, are
from Zone IV to a magnetically safe deemed “MR Safe,” whereas those
location, and securing the door to Zone IV. contraindicated, such as a ferromagnetic
The ACR Committee on MR Safety now aneurysm clip, are labeled “MR Unsafe.” “MR
recommends that other than when the door Conditional” devices can be safely scanned
is open for personnel and patient transit providing the specific conditions for safe
across the threshold, the door is to be scanning are appropriately adhered to,
closed, or is to be protected by a physical including magnetic field strength (e.g., 1.5T or
barrier, such as a retractable safety strap, 3T), specific coils that are permissible (e.g.,
plastic chain, or specific doorway gate some device conditions require use of a local
device. transmit/receive coil at a distance from a device,
and do not permit use of a receive-only coil
The major transition happens from Zone II to
using the magnet RF coil), and specific RF
Zone III. MR personnel working within Zone III
deposition parameters (e.g. a defined SAR, such
and Zone IV should have specific education on
at 1.0 W/kg). Published information is available
MR safety and pass an MR safety screening
regarding the MR safety of most medical
process. Therefore, there are two safety levels of
implants, and it is essential that the
MR personnel which are characterized as Level
manufacturer’s most up to date MR safety
1 and Level 2. Level 1 personnel have passed
information defining the MR conditions for safe
the facility’s MR safety education requirements
scanning are used, as these change frequently.
to ensure that they would not be a danger to
themselves or others. Level 1 personnel are not Ferromagnetic objects should be restricted from
to be independently responsible for the safety entering Zone III whenever practical. All MR
of others in Zone IV. Level 2 personnel are sites should have a handheld magnet (≥ 1000
more extensively trained, including topics such Gauss) for testing purposes. Ferromagnetic
as radiofrequency (RF)-induced heating, etc. detection devices, either wall mounted or
Level 2 personnel can be independently handheld, can augment safety screening
responsible for the safety of others in Zone IV. processes in helping identify unknown
ferromagnetic objects concealed on a patient,
All other non-MR personnel and patients
and some superficial internal implants, such as
entering Zone III should be appropriately
pacemakers. To minimize risk of unsafe items
screened. MR screening begins with a focused
entering Zone IV, and to minimize risk of burns
history to identify potential metallic foreign
from potential metallic fibers in clothing, the
objects and medical implants. This may be
ACR Committee on MR Safety now
supplemented as needed by reviewing any
recommends that all MR patients are changed
existing radiographs, CT, or MR of the
into MR safe gowns or scrubs.
questioned area as well as operative reports

2025 Noninterpretive Skills Study Guide 34

Occasionally, devices that are determined to be marked on the floors or walls for safety,
ferromagnetic and MR unsafe may be particularly when it extends beyond the walls
permitted into Zone III. These must be of the MR scanner room. It is important to
appropriately secured or tethered at all times remember that the magnetic field is three-
and be under the supervision of trained MR dimensional. Thus, the restricted area may
personnel. extend through the floor and/or ceiling to
adjacent floors.
The strong magnetic field inherent to an MR
scanner can pose a risk for projectile injury if a 4.1.2 Implanted devices
ferromagnetic object (e.g., hospital gurney,
Medical devices contain varying amounts of
scissors, cell phone) is brought too close in
ferromagnetic material and can be subject to
proximity. There have been reports of projectile
translational and rotational forces when
injuries from anesthetic gas or oxygen
interacting with the magnetic field of an MR
cylinders, and even patient deaths. In addition
unit. In addition, presence of any conducting
to injuring patients, projectiles may also cause
metal can result in current generation from the
extensive damage to the MR unit. It is
radiofrequency B1 field and interactions with
important to understand that magnetic
the gradient dB/dt field. All metal-containing
attraction does NOT increase linearly as one
implants are considered either MR unsafe (e.g.,
approaches the magnet. The spatial gradient
a ferromagnetic aneurysm clip), or MR
magnetic field increases very steeply in close
conditional (e.g., a titanium aneurysm clip, a
proximity to the magnet such that in a short
nitinol stent, an MR conditional cardiac
distance one can perceive very little magnetic
pacemaker system). There has been at least one
pull on a ferromagnetic object, and then when
documented case of a fatality due to rotation of
only a short distance closer, the object is
an MR unsafe ferromagnetic aneurysm clip
subjected to a tremendously higher attractive
while the patient was in the MR scanner. If a
force, typically ripping an object from one’s
patient is identified to have an intracranial
grasp in an uncontrolled manner.
aneurysm clip(s), MRI should not be performed
Screening is more difficult when the patient is until the specific manufacturer, model, and
unconscious or otherwise unable to provide a type of (each) aneurysm clip is definitively
reliable history. In such cases, screening should identified, and its MR safety conditions
be performed as effectively as possible from identified. Although a patient may previously
other sources, such as family members and the have undergone an MR examination with an
medical record, and the urgency of the aneurysm clip, that fact alone is not sufficient to
examination should be balanced with the level conclude that the clip is MR Conditional.
of uncertainty of the screening process. An
Cardiac implantable electronic devices (CIED)
examination by trained MR personnel should
similarly can be adversely affected by the B0, B1,
be performed to assess for surgical scars that
and dB/dt fields, potentially leading to
may warrant additional evaluation.
complications, including failure to pace,
Radiography may be required to assess for
induction of ventricular fibrillation, and heating
foreign bodies, implants, or devices.
of cardiac tissue adjacent to the leads; these
The 9 gauss line is the point at which the complications can potentially be fatal. FDA-
magnetic field begins to affect electromagnetic labeled MR Conditional pacemakers became
devices such as pacemakers. This line should be available in February 2011 If MRI is performed

2025 Noninterpretive Skills Study Guide 35

on a patient with a MR conditional CIED, the media, has not been shown to have a
conditions for scanning must be followed in detrimental effect on the developing fetus. For
their entirety, including attention to magnet this reason, no special consideration is
field strength, scanning parameters, and recommended during pregnancy regarding
cardiology programming of the device, and exposure to noncontrast MRI up to 3T at
monitoring the patient throughout the exam in normal operating mode. However, since it is
the presence of ACLS trained personnel, with impossible to completely exclude the possibility
ready availability of a crash cart should of any risk whatsoever, patients and clinicians
resuscitation be necessary. Of note, CIED should consider whether it is safe to delay an
systems not specifically labeled as MR MR examination until the end of pregnancy.
conditional are being scanned at some centers Pregnant healthcare workers may work in an
in an informed consent manner following MRI environment during all stages of
guidelines established by the Heart Rhythm pregnancy, but they should not remain in Zone
Society and the ACR. Some of the specific IV during data acquisition or scanning.
elements that must be in place for this to occur
4.1.4 MR-induced Burns
include: 1) there is to be an institutional
protocol in place with a responsible MRMD and The possibility of thermal injury and burns,
CIED MD using a Radiology / Cardiology team some severe, in MRI is predominantly due to
approach; 2) medical necessity for the exam; 3) the radiofrequency (RF) fields. Physical contact
patient monitoring of ECG and pulse oximetry; alone with the inner surface of the bore can
4) defibrillator/monitor with external pacing produce burns, and insulating pads are
available (outside Zone IV); 5) ACLS personnel necessary to keep skin at least 1 to 2 centimeters
in attendance during exam; and 6) appropriate from the surface. In a large patient, tightly
CIED reprogramming post MRI. wedging a sheet in place of a pad between the
skin and the bore, not maintaining the requisite
The number of active implanted medical
distance, creates a distinct risk of burns, and is
devices (devices that contain an energy source
specifically not recommended in the ACR
such as a battery or can be inductively coupled)
Manual on MR Safety. RF fields can also induce
continues to rapidly increase, including many
currents within the body, particularly when a
types of neurostimulators (e.g., deep brain,
“closed loop” is formed; for example, if there is
spinal cord, hypoglossal nerve, cochlear
skin-to-skin contact at the inner thighs. If there
implants) and medication pumps. It cannot be
is only a small surface area of skin-to-skin
emphasized enough that there must be precise
contact, greater current density and resistive
identification of the make and model of each
heating can lead to burns. Skin-to-skin burns
component of an implanted device system (e.g.,
have also occurred when overhanging
in the case of a spinal cord stimulator system,
abdominal panniculus in an obese patient
this is to include the implanted pulse generator
contacts the upper thigh. Care must be taken to
as well as the leads) and if MR conditional, the
ensure that padding prevents such situations.
conditions for scanning must be strictly
Commercial pads are available that have
adhered to.
notches in them to keep thighs separated,
4.1.3 MR and Pregnancy minimizing this skin-to-skin contact risk.
MRI exposure alone, without the Other sources of heating can be associated with
administration of gadolinium-based contrast metallic fibers in clothing, especially

2025 Noninterpretive Skills Study Guide 36

undergarments, and burns related to this have quench pipe accommodates the explosive force
been reported. To minimize this risk, it is of the rapidly boiling helium gas, by allowing it
recommended that patients change out of street to escape into the atmosphere.
clothes into hospital gowns or similar MR safe
If a quench pipe fails during a quench (due to
attire. Loops of metallic wire (e.g., from
an obstruction or break), the enormous volume
electronic physiologic monitoring equipment),
of cold helium gas flowing into the magnet
patches of metal (e.g., in foil backed medication
room (Zone IV) would be extremely hazardous
patches), and other electrical conduction
because it would displace oxygen toward the
circuits may be rapidly heated by RF pulses
floor, creating a significant risk of asphyxiation.
during normal operation of an MRI system.
Cold helium gas flooding the room would form
Because of the risk of burns, care must be taken
a fog, making it impossible to see. An inward-
to prevent such loops or metallic patches from
swinging door to Zone IV would create the risk
touching patients’ skin during routine
of positive pressure entrapment. Because of
scanning. As the RF resonant wavelength is a
these risks, emergency procedures associated
function of magnet field strength (52 cm at 1.5T
with a quench should always include
and 26 cm at 3T), leads or other conductors can
immediate evacuation of Zone IV. A magnet
have drastically different tendencies to heat in
quench can occur spontaneously due to
different magnets.
equipment failure. In a situation when the
As noted, certain transdermal patches may magnetic field must be shut off immediately
contain aluminum and other conductive metals (e.g., personnel pinned to the magnet by a
that may cause RF burns. If medication patches ferromagnetic hospital gurney), a quench can
are removed for MRI, there must be a clear line be initiated by pressing a quench button.
of communication to ensure medication
replacement after the MRI, particularly for
some critical medications (e.g., clonidine foil 4.2 Management of Intravascular
backed patches). Occasionally, large tattoos Contrast Media
may undergo heating and cause burns; 4.2.1 Iodinated Contrast Media
application of a cold compress or an ice pack
may be necessary to reduce the risk of skin Types of Iodinated Contrast Media
burning. All iodinated contrast media are derived from
4.1.5 Quenching tri-iodinated benzene rings. Iodinated contrast
media can be classified as ionic or nonionic, and
The main magnetic field is maintained by
monomeric or dimeric.
bathing the electromagnetic coils of the MR
scanner in large volumes (typically 1500 to 2000 Ionic contrast media dissociate into two
L) of extremely cold liquid helium (-269°C, particles in solution (an anion, which contains
4°K). A “quench” occurs when heating of a the tri-iodinated benzene ring, and a cation,
segment of the electromagnetic coils makes consisting of sodium or methylglucamine
them no longer superconducting. This produces [meglumine]). Nonionic contrast media are
further heat in the coils, and collectively, these hydrophilic molecules that do not need to be
events produce a rapid change of state of the conjugated with cations to be water soluble.
liquid helium into a gas (with a 760-fold They do not dissociate in solution.
increased volume). A specifically designed Monomeric contrast molecules contain only one

2025 Noninterpretive Skills Study Guide 37

tri-iodinated benzene ring, while dimeric less likely to occur, and when they do occur,
contrast molecules contain two joined tri- they are less likely to be severe when lower
iodinated benzene rings. doses of contrast material are administered.
They are believed to represent direct toxic
At standard iodine concentrations, ionic
effects of the injected contrast media.
monomeric contrast media have the highest
osmolality, roughly four times that of human The mechanism of allergic-like reactions is not
serum. They are referred to as high-osmolality understood in most patients. However, it is
contrast media. These agents are not employed known that in most patients these reactions do
routinely for intravascular injection in the not represent the antigen-IgE antibody
United States as they are associated with higher response characteristic of typical allergic
rates of adverse reactions than are nonionic reactions, such as to penicillin. Therefore,
monomeric or dimeric contrast media. sensitization due to prior exposure is not
required for an allergic-like reaction to contrast
Nonionic monomeric contrast media have
material to occur. Thus, these reactions are
about half the osmolality of high-osmolality
generally considered to be “allergic-like” rather
contrast media, and roughly twice that of
than “allergic.” Nonetheless, allergic-like
serum. Nonionic dimers have similar
reactions present with symptoms similar to
osmolality to that of plasma and are referred to
those of true allergic reactions. These reactions
as iso-osmolality contrast media. Iso-osmolality
are idiosyncratic and can occur from any
media are sometimes used for intra-arterial
administered volume of contrast media.
injection (and uncommonly for intravenous
injection), because they cause less discomfort Acute adverse reactions are categorized as
than do nonionic monomers when injected into being mild, moderate, or severe. Examples of
the arteries. some reactions of different types and severity
as summarized in the ACR Manual on Contrast
Many nonionic contrast media are approved for
Media are as follows:
intravascular use in the United States, including
the low-osmolality agents iohexol Mild Reactions: Signs and symptoms are self-
(Omnipaque®), iopamidol (Isovue®), iopromide limited and without progression.
(Ultravist®), ioversol (Optiray®), and ioxilan
1. Mild Physiologic Reactions: Nausea,
(Oxilan®). Only one iso-osmolality contrast
vomiting, flushing, warmth, chills,
agent has been approved for use: iodixanol
headache, anxiety, altered taste, mild
(Visipaque®).
hypertension, and spontaneously
Adverse Reactions to Iodinated Contrast Media resolving vasovagal reaction
Most patients who receive iodinated contrast 2. Mild Allergic-like Reactions: Few hives,
media have no adverse effects. Adverse pruritus, limited cutaneous edema,
contrast reactions of any type have been itchy/scratchy throat, nasal congestion,
reported in up to 3% of patients injected with repetitive sneezing, stuffy nose
nonionic contrast material, though some series
Moderate Reactions: Signs and symptoms are
have reported a much lower frequency.
more pronounced and commonly require
Acute adverse reactions can be categorized as medical management.
either physiologic or allergic-like. Physiologic
reactions are dose related. These reactions are

2025 Noninterpretive Skills Study Guide 38

 1. Moderate Physiologic Reactions: Risk Factors for Adverse Reactions
Protracted nausea, chest pain, vasovagal
Several factors increase the likelihood of an
reaction that requires and is responsive to
adverse reaction to contrast media. Patients
treatment
with a history of a prior allergic-like reaction to
2. Moderate Allergic-like Reactions: Diffuse the same class of contrast media (iodinated or
hives, diffuse erythema (with stable vital gadolinium-based) are believed to have
signs), facial edema without dyspnea, approximately five times the risk of the general
wheezing with mild or no hypoxia. population for having another allergic-like
reaction to that same class of contrast media.
Severe Reactions: Signs and symptoms are
Patients with other allergies and asthma are
potentially life threatening and can result in
about two to three times as likely to have an
permanent morbidity or death if not managed
allergic-like reaction. Allergies to shellfish or
appropriately.
other iodine-containing products (such as
1. Severe Physiologic Reactions: Vasovagal povidone-iodine [Betadine®]) are not believed
reaction resistant to treatment, arrhythmia, to increase the risk for an allergic-like contrast
seizures, hypertensive crisis, pulmonary reaction beyond that of other allergies. Also, a
edema, cardiopulmonary arrest. history of a prior allergic-like reaction to
2. Severe Allergic-like Reactions: Diffuse gadolinium-based contrast media (GBCM) is
edema or facial edema with dyspnea, not believed to increase the risk of an allergic-
erythema with hypotension, laryngeal like reaction to iodinated contrast agents above
edema with stridor and/or hypoxia, that of other allergies and vice versa.
wheezing with hypoxia, severe Some patients’ underlying diseases may be
hypotension and tachycardia, pulmonary exacerbated by administration of contrast
edema, cardiopulmonary arrest. media. Such disease exacerbations are
As noted above, pulmonary edema and considered to be non-allergic-like reactions.
cardiopulmonary arrest can be symptoms of These can occur in patients with severe chronic
either severe physiologic or severe allergic-like kidney disease (CKD) and acute kidney injury
reactions. (AKI) (see section on postcontrast AKI), cardiac
arrhythmias, congestive heart failure,
Fortunately, a clear majority of acute adverse
myasthenia gravis, and severe
reactions to contrast media are physiologic,
hyperthyroidism.
mild, and self- limiting, often consisting of
warmth, metallic taste, and nausea. Allergic- Additional attention should be paid to the use
like reactions are much less common, of intravascular iodinated contrast media in
encountered in < 1% of injected patients. In one patients with thyroid cancer or
recent series, 0.6% of patients injected with low- hyperthyroidism who are anticipating
osmolality contrast media had allergic-like treatment with radioactive iodine (131I). Such
reactions, most of which were mild. Severe life- patients should not receive iodinated contrast
threatening allergic-like reactions are extremely in the 4 to 6 weeks before anticipated
rare, with the incidence of such reactions radioiodine treatment, because the
estimated to be 0.01% to 0.04% of injected nonradioactive iodine load delivered by the
patients. contrast media will saturate the thyroid gland
and could render treatment ineffective.

2025 Noninterpretive Skills Study Guide 39

Screening of Patients before Contrast Media contrast media injection. While a 12- or 13-hour
Administration oral regimen has been proven effective, and a 1-
or 2-hour oral regimen has been proven to be
Safe administration of contrast media begins
ineffective, the precise minimum effective time
with a focused patient history to identify the
for premedication is not known.
factors that may increase the likelihood of an
adverse reaction to contrast media. Premedication can also be administered to
children who have had prior allergic-like
The likelihood of an allergic-like contrast
contrast reactions. One recommended regimen
reaction may be reduced by premedication.
calls for administration of 0.5-0.7 mg/kg of oral
Premedication prednisone at 13, 7, and 1 hours prior to
Premedication may be considered for patients contrast injection, up to a maximum of 50 mg,
who are at increased risk of an acute allergic- with one dose of oral diphenhydramine
like reaction to contrast media. The ACR (Benadryl ®) one hour prior to injection, at a
Manual on Contrast Media (2020) suggests dose of 1 mg/kg, up to a maximum dose of 50
consideration of premedication only for mg.
patients who have had a prior allergic-like or In some situations, patient health can be
unknown-type reaction to the same class of seriously jeopardized by having the patient
contrast media as that to be administered. wait 12 or more hours before a contrast-
However, policies vary by site, but it is enhanced study. In these situations, “rapid”
generally agreed in the United States that corticosteroid regimens may be utilized, with
premedication is indicated at least in patients the understanding that limited evidence
who have had a previous moderate or severe supports this approach. The ACR Manual on
allergic-like reaction to the same class of Contrast Media (2020) suggests using one of
contrast media. Surveys have shown that some, these regimens in inpatients and Emergency
but fewer, institutions administer Room patients. One of the more commonly
premedication to patients with a history of a used rapid preps consists of intravenous (IV)
mild allergic-like reaction to the same class of administration of 200 mg of hydrocortisone
contrast media, to patients with a history of every 4 hours until the study is performed,
allergies to substances other than contrast preferably deferring imaging until at least two
media, or to patients with a history of asthma. doses of hydrocortisone have been
The most widely accepted premedication administered. In this rapid prep, 50 mg of
regimens, or “preps,” involve the use of oral diphenhydramine is also administered 1 hour
corticosteroids, with the first dose administered before contrast media injection. In the rare
12 to 13 hours before contrast media injection. emergency situation where a contrast-enhanced
One common adult regimen involves oral examination must be performed immediately,
administration of 50 mg of prednisone 13, 7, the contrast media may have to be
and 1 hour(s) before contrast media injection, administered without premedication.
and oral administration of 50 mg of The only proven benefit of corticosteroid
diphenhydramine (Benadryl®) 1 hour before premedication regimens is a reduction in the
injection. Another common regimen involves number of mild reactions. Studies showing the
oral administration of 32 mg of reduction in the number of mild reactions after
methylprednisolone 12 and 2 hours before premedication did not have sufficient numbers

2025 Noninterpretive Skills Study Guide 40

of patients with moderate, severe, or life- hyperglycemia can occur from three doses of
threatening reactions to draw statistically corticosteroids, it is usually mild and is rarely
significant conclusions about the ability of clinically significant. Other complications from
premedication to reduce those reaction rates. a short burst of corticosteroids, such as
Thus while there is no definite evidence that exacerbation of infection and peptic ulcer
premedication protects against moderate, disease, steroid psychosis, and tumor lysis
severe, or life-threatening reactions, it is syndromes, have been reported, but are very
typically assumed that there is a positive effect. rare.
The rarity of severe reactions makes it difficult
Postcontrast Acute Kidney Injury and Contrast-
to prove a benefit of premedication in this
induced Nephropathy
setting.
Postcontrast acute kidney injury (PC-AKI) is a
Premedication likely reduces the risk of a
general term used to describe a sudden
contrast reaction in high-risk patients, but it
deterioration in renal function that occurs after
does not eliminate it. A contrast reaction that
the intravascular administration of iodinated
occurs despite premedication is called a
contrast media (with clinical onset detectable
“breakthrough reaction.”
within 24 to 48 hours as creatinine accumulates
Even with appropriate use of an accepted in the serum). Such injury may occur whether
premedication regimen, breakthrough reactions or not the contrast medium is determined to
occur in a small number of high-risk patients. have caused the deterioration in renal function.
When they do occur, they are of similar severity PC-AKI is a correlative diagnosis, meaning that
to the initial reaction about 80% of the time, less AKI can be correlated to, but not proven to be
severe about 10% of the time, and more severe caused by, the administration of IV contrast.
about 10% of the time.
Contrast-induced nephropathy (CIN) is defined
A patient who has had an allergic-like reaction as a sudden deterioration in renal function
to contrast media despite steroid premedication caused by intra- vascular administration of
can be reinjected in the future after being iodinated contrast media. CIN is a subset of PC-
premedicated again, if clinical circumstances AKI, that is, those cases of PC-AKI in which
require reinjection. Many such patients will not iodinated contrast media is proven or known to
have a repeat reaction, and if a repeat reaction be the cause of the AKI; CIN is more of a
occurs, it will most likely be of the same statistical concept because it is difficult in
severity as the previous breakthrough reaction practice to identify which individual cases of
(e.g., mild subsequent breakthrough reaction if PC-AKI can be proven to be due to the contrast
the previous breakthrough reaction was mild). media. For example, if a group of patients who
are administered iodinated contrast media have
The greatest risk of corticosteroid
a higher rate of PC-AKI than a properly chosen
premedication to patient health is probably the
control group of patients not receiving
delay that it causes in the performance of an
iodinated contrast media, then the excess rate is
imaging study (which can delay disease
due to CIN, but it is not generally not possible
diagnosis, increase cost, and, in inpatients,
to identify which patients have PC-AKI from
expose patients to the additional risk of
CIN and which have PC-AKI from causes other
hospital-acquired infections for longer periods
than contrast media.
of time). For such patients, use of the “rapid”
prep has been recommended. While transient Nearly all papers published on CIN before

2025 Noninterpretive Skills Study Guide 41

2006, and many afterwards, considered all PC- This dose-toxicity relationship has been
AKI to be CIN. This error has led to consistently shown after coronary
substantially inflated estimates of the rate of arteriography, but has not been conclusively
CIN. It is now known that most PC-AKI is not shown for IV administrations.
due to CIN.
The historical definition of PC-AKI refers to an
CIN was previously believed to be common, absolute increase in serum creatinine from
because a clear majority of published studies baseline of at least 0.5 mg/dL, or a 25% to 50%
that came to this conclusion did not include increase in the baseline serum creatinine. The
control groups of patients who did not receive Acute Kidney Injury Network (AKIN) has
contrast media. For this reason, distinction suggested that, regardless of the cause, AKI
between CIN and PC-AKI was not possible in should be diagnosed whenever there is 1) an
these studies. Additionally, many previous absolute serum creatinine increase of at least 0.3
publications studied patients who had mg/ dL; or 2) a percentage increase in serum
undergone arteriography rather than IV creatinine of at least 50% (1.5-fold above
contrast media injections. Catheter angiography baseline); or 3) a reduction in urine output to
may be associated with additional risks to the 0.5 mL/kg/h for at least 6 hours.
patient that could also affect renal function,
The usual clinical course of PC-AKI (including
including catheter manipulation in the
CIN) is a rise in serum creatinine beginning
abdominal aorta (i.e., atheroemboli) and
within 24 hours of contrast media
exposure of the kidneys to more concentrated
administration, peaking at about 4 days and
contrast media.
then usually returning to baseline by 7 to 10
With the recent performance of several large days. Most affected patients do not have
propensity-adjusted controlled retrospective oliguria. Permanent renal dysfunction is
studies, it is now understood that true CIN is unusual.
much less common than previously thought,
In addition to severe renal dysfunction, other
and if CIN occurs at all, it is most likely to
previously identified diseases or conditions
develop in patients who have severe CKD
may predispose patients to develop AKI, but
(estimated glomerular filtration rate [eGFR] <
most likely, in and of themselves, they do not
30 mL/min/1.73 m2) or AKI. CIN occurring in
specifically predispose patients to develop CIN.
patients with an eGFR of 45 mL/min/1.73 m2 or
These include diabetes mellitus, dehydration,
higher is very unlikely, and in patients with an
cardiovascular disease, diuretic use, advanced
eGFR between 30 and 45 mL/min/1.73 m2, it is
age, multiple myeloma, hypertension, and
questionable. As a result, special precautions
hyperuricemia.
for administering intravascular iodinated
contrast media are advised only for patients Although patients with end-stage renal disease
with severe CKD or AKI. Administration of who are on chronic hemodialysis could
large or multiple doses of contrast media within experience additional renal function
24 to 48 hours may also be a risk factor for AKI, compromise (resulting in a further decrease in
although precise risk thresholds are not well any remaining urine output that might be
defined and likely vary by patient condition, helpful for managing electrolyte balance), such
and whether the contrast medium is a risk is theoretical. Many nephrologists agree
administered intra-arterially or intravenously. to inject these patients with intravascular
contrast media if a contrast- enhanced study is

2025 Noninterpretive Skills Study Guide 42

necessary. There is also a possibility that such with severe CKD or AKI —see separate section
patients, if their fluid status is brittle, could on NSF). When iodinated contrast media
develop fluid overload as a result of the administration is deemed necessary in high-risk
administration of even a relatively small patients, the lowest possible dose needed to
volume of hyperosmolality contrast media. perform a diagnostic study should be used.
Because iodinated contrast media have no The most widely accepted strategy for
significant toxicity if retained in the body after minimizing the risk of PC-AKI in at-risk
injection, there is no requirement that chronic patients is IV volume expansion with isotonic
hemodialysis be timed to occur either fluids, such as 0.9% saline or Lactated Ringer’s
immediately before or immediately after solution. Some suggested volume expansion
contrast media administration. protocols have included administration of
volumes of 100 mL/h for 6 to 12 hours before
Some nephrologists advocate more caution in
contrast administration and continued for 4 to
administering potential nephrotoxins such as
12 hours after contrast administration. Volume
intravascular iodinated contrast to patients on
expansion with sodium bicarbonate solution
peritoneal dialysis because the urine output of
instead of saline or Lactated Ringer’s solution
these patients may be more important to their
has been used, but it is not clear that this
well-being than for patients on chronic
solution is any more efficacious.
hemodialysis.
Several other prophylactic agents have been
There is some controversy concerning screening
suggested, but there is no consistent proof that
of patients’ renal function before contrast media
any of these are effective in preventing PC-AKI
administration if no recent serum creatinine
or CIN. Administration of N-acetylcysteine has
level/eGFR level is available. Suggested
been widely studied and is now thought to be
indications for obtaining a serum creatinine,
of no value. Other agents, such as mannitol,
from which an eGFR can be determined, have
furosemide, theophylline, etc., have been
included a history of renal disease (including
discredited.
dialysis, renal transplant, solitary kidney, renal
cancer, or renal surgery), hypertension and It has recently been shown that prophylactic
diabetes mellitus. If a potentially at-risk administration of high-dose statins appears to be
patient’s condition is stable, a creatinine value effective in reducing the risk of PC-AKI after
within 30 days of contrast administration is cardiac catheterization.
generally considered sufficient.
Metformin
In patients with severe CKD or AKI who are
Metformin-containing drugs are prescribed as
considered at increased risk of developing CIN,
oral agents of choice for treating many patients
several prophylactic strategies should be
with diabetes mellitus. Metformin is
considered. Since most iodinated contrast
contraindicated in patients with severe renal
media are currently administered intravenously
dysfunction because a very small percentage of
for CT scans, alternatives include performing
these patients develop lactic acidosis, leading to
only unenhanced scans or using other
a reported 50% mortality rate.
modalities such as ultrasound or MR (note that
contrast-enhanced MR performed with certain There is no direct interaction between iodinated
MR contrast media is associated with a risk of contrast media and metformin; however, if a
nephrogenic systemic fibrosis [NSF] in patients patient receiving metformin develops AKI, the

2025 Noninterpretive Skills Study Guide 43

possibility of developing lactic acidosis exists. adverse effect on the infant. Although it is
The American College of Radiology Committee generally accepted that no precautions need to
on Drugs and Contrast Media currently be taken, it is recommended that a lactating
recommends that no precautions are necessary mother be informed that studies assessing the
in diabetic patients taking metformin, unless risks to an infant are limited. If concerned, the
the patient has CKD and the eGFR is < 30 mother can abstain from breastfeeding for 12 to
mL/min/1.73 m2 (in which case the patient 24 hours after a contrast-enhanced study is
should not be taking metformin anyway), the performed and pump and discard breast milk
patient has AKI, or the patient is undergoing that is produced during this time.
arterial catheterization with the risk of emboli
Extravasation
to the renal arteries. In the latter instances, the
drug should be withheld for 48 hours after Extravasation of IV-administered iodinated
contrast media administration and only contrast media is an occasionally encountered
reinstituted if the renal function is reassessed complication of intravascular contrast media
and found to be acceptable. administration, usually occurring during CT.
The reported overall rate of extravasation with
Thus, metformin itself is not a risk factor for the
power injection for CT ranges from 0.1% to
development of CIN, but patients who develop
1.2%. While extravasations are more likely to
renal failure while taking metformin are at risk
occur when poor catheter insertion technique is
of developing lactic acidosis.
utilized, they can be encountered even when
Iodinated Contrast Media in Pregnancy proper technique is employed.
Although iodinated contrast media cross the Patients are believed to be at increased risk for
placenta, there is no evidence that maternal extravasation when more peripheral access sites
exposure to intravascular iodinated contrast are used (such as the hand, wrist, foot, and
media is harmful to the fetus. Specifically, there ankle) rather than the antecubital fossa, when
is no evidence that fetal exposure to iodinated utilized indwelling lines have been in place for
contrast media increases mutagenesis or fetal more than 24 hours (in which case some degree
cancer risk or affects fetal renal function. of phlebitis may be present), and when there
are multiple punctures into the same vein.
Iodinated Contrast Media in Women Who Are
Certain risk factors are believed to be associated
Breastfeeding
with an increased volume of extravasated
Only 1% of maternally administered contrast contrast, including inability of the patient to
media enters the milk of breastfeeding mothers communicate (as is the case with infants, young
and, of this, only 1% of the contrast media in children, and patients with altered
breast milk is absorbed through an infant’s consciousness), severe illness, and debilitation.
gastrointestinal tract.
Immediately after extravasation of contrast
This represents less than 1% of the media occurs, most patients complain of
recommended infant dose of iodinated contrast swelling or tightness and/or stinging or burning
media that could be used for a contrast- pain at the site of extravasation. Edema,
enhanced imaging study on that infant. erythema, and tenderness may be found on
There is no evidence that this tiny amount of physical examination. Ninety-eight percent of
absorbed iodinated contrast media has any extravasation injuries resolve with no adverse
sequelae. In the remaining 2% of injuries, some

2025 Noninterpretive Skills Study Guide 44

patient morbidity develops because contrast level of the heart is recommended to decrease
media can damage adjacent tissue, likely due to capillary hydrostatic pressure. This may
a combination of direct toxic effects and its promote resorption of the extravasated contrast
hyperosmolality. Adverse effects are usually media. Cold compresses or ice packs can be
self-limited, most commonly consisting of applied to the site of extravasation. Attempted
prolonged pain or swelling. aspiration of the extravasated contrast media
and injection of medications into the
Severe extravasation injuries occur in < 1% of
extravasation site (such as corticosteroids or
patients with extravasations. The most common
hyaluronidase) are ineffective.
and most potentially devastating severe injuries
after extravasation of nonionic contrast media Surgical consultation should be obtained after
are compartment syndromes, which result from an extravasation whenever there is concern for
mechanical compression. Skin ulceration and a developing compartment syndrome or for
tissue necrosis are less commonly encountered. tissue necrosis. Ominous symptoms that
Other complications, including lymphedema indicate the need for prompt surgical
and reflex sympathetic dystrophy, are consultation include progressive swelling or
extremely rare. pain, decreased finger mobility, altered tissue
perfusion (manifested by decreased capillary
Compartment syndromes are more likely to
refill), change in sensation, or skin ulceration or
develop when large volume extravasations
blistering. In some instances, it may be difficult
occur, especially into smaller compartments
to recognize the early signs of a compartment
such as the hand, wrist, or foot, but even large-
syndrome. Symptoms concerning for severe
volume extravasations most often resolve
extravasation injury includeworseningpain or
without any adverse effects. The risk of a severe
failureofexistingpainto improve;decreasingarm,
extravasation injury may also be increased in
wrist, orfingermotion;lossof sensation or
patients with arterial insufficiency or
paresthesia in the affected extremity; and skin
compromised venous or lymphatic drainage.
breakdown.
Severe symptoms may not be evident
In general, however, the earliest and most
immediately after the extravasation occurs.
reliable sign of a severe injury is severe or
They may develop gradually over time. For this
progressive pain. It should be noted that there
reason, patients should be monitored to assure
is no extravasation volume threshold above
that minor symptoms remain stable or that
which surgical consultation is considered
minor or more significant symptoms are
mandatory.
resolving or improving. When a
symptomatically stable or improving patient is 4.2.2 Gadolinium-based Contrast Media
discharged from the radiology department, he (GBCM)
or she must be given clear instructions
Classification of GBCM
concerning what new or recurring symptoms
may indicate a severe injury and where and Most contrast agents used for MRI contain
how to seek prompt additional treatment if gadolinium bound within a chemical moiety
necessary. called a chelate.

Little can be done to mitigate the effects of Gadolinium-based contrast media (GBCM) are
contrast extravasations after they occur. classified as linear or macrocyclic, and ionic or
Elevation of the affected extremity above the nonionic. In general, macrocyclic GBCM, in

2025 Noninterpretive Skills Study Guide 45

which the gadolinium ion is surrounded by a nonionic agents are less stable than the ionic
chelate ring, have more stable binding of the agents. Table 4.1 summarizes the gadolinium-
gadolinium ion within the chelate than do containing contrast agents currently available
linear agents, in which the chelate is not in the for use in the United States.
form of a ring. Among the linear agents, the

Agent Ionicity Linear or macrocyclic

Gadopentetate dimeglumine Ionic Linear

(Magnevist®)1
Gadobenate dimeglumine Ionic Linear
(MultiHance®)2
Gadoxetate disodium (Eovist®)3 Ionic Linear

Gadodiamide (Omniscan®)1 Nonionic Linear

Gadoteridol (ProHance®)2 Nonionic Macrocyclic
Gadobutrol (Gadavist®)2 Nonionic Macrocyclic
Gadoterate meglumine Ionic Macrocyclic
(Dotarem®)2 (Clariscan®)2

Table 4.1. Characteristics of approved gadolinium-containing contrast agents.

1Indicates agents that have a higher risk for nephrogenic systemic fibrosis (NSF)
2Indicates agents that have a lower risk for nephrogenic systemic fibrosis (NSF)
3Indicates agent with limited evidence regarding association with nephrogenic

systemic fibrosis (NSF)

Acute adverse reactions to GBCM occur with or without vomiting, headache, warmth or
approximately two to four times less frequently pain at the injection site, paresthesias, and
than acute adverse reactions to iodinated dizziness. Rash, hives, and urticaria are the
contrast media. In general, the physiologic and most frequent allergic-like symptoms; however,
allergic-like reactions that occur after GBCM respiratory and cardiovascular reactions can
administration are similar to those that occur occur. Fatal contrast reactions have been
after injection of iodinated contrast agents. For reported but are exceedingly rare.
this reason, treatment of contrast reactions to
A unique physiologic side effect of gadoxetate
GBCM is similar to that of contrast reactions to
disodium (Eovist®) is transient tachypnea,
iodinated contrast media (see separate section
which can cause motion artifact on arterial-
on treatment, to follow).
phase MRI. It is more common with high
A clear majority of GBCM reactions are mild volume, off-label administrations.
and non-allergic-like (i.e., physiologic),
Patients at highest risk for adverse reactions to
including coldness at the injection site, nausea
GBCM are those who have had previous

2025 Noninterpretive Skills Study Guide 46

reactions to these agents (even to different of the potentially toxic gadolinium ion (see
GBCM). Lesser risk factors include other separate section on nephrogenic systemic
allergies and asthma. A history of a prior fibrosis, to follow). For this reason, GBCM
allergic-like reaction to iodinated contrast should only be administered to pregnant
media is not believed to increase the risk of an patients in carefully selected situations in which
allergic-like reaction to GBCM above that of the benefit is thought to outweigh the potential
other allergies. risk.
Some preventive measures can be considered in GBCM in Women Who Are Breastfeeding
patients who have experienced previous
Only tiny amounts (0.04%) of administered
adverse reactions to GBCM. This includes using
GBCM are excreted into the milk of
a different gadolinium compound for
breastfeeding mothers, and only a tiny
reinjection. It should be noted that the FDA-
percentage of this (1%) GBCM is absorbed
approved package insert for one GBCM
through an infant’s gastrointestinal tract. This
(gadobenate dimeglumine [MultiHance®])
is much less than the allowed GBCM dose,
states that use of this GBCM is specifically
when a contrast-enhanced imaging study is
contraindicated in patients who have had prior
needed in an infant. There is no evidence that
allergic-like contrast reactions to ANY GBCM.
the tiny amount of absorbed GBCM has any
Another preventive measure is premedicating
adverse effect on a breastfed infant. Therefore,
patients with corticosteroids and antihistamines
there is no need for a mother to stop
(using a regimen identical to that used for
breastfeeding after a GBCM-enhanced study.
prophylaxis of adverse reactions to iodinated
However, as with the administration of
contrast media) before injection. The
iodinated contrast media, if the mother is
effectiveness of premedication before GBCM
concerned, she can stop breastfeeding for 12 to
has not yet been determined, but premedication
24 hours after the study, and pump and discard
is still often performed, based on evidence
any milk produced during this time.
extrapolated from experience with iodinated
contrast media. Nephrogenic Systemic Fibrosis (NSF)

GBCM in Pregnancy Nephrogenic systemic fibrosis (NSF) is a

fibrosing disease most evident in the skin and
GBCM have been classified by the Food and
subcutaneous tissues, but it also may involve
Drug Administration as pregnancy class C
other organs, such as the lungs, esophagus,
drugs (no adequate and well-controlled studies
heart, and skeletal muscles. Initial symptoms
in humans have been performed, although
typically include skin thickening with plaque
animal reproduction studies have shown an
formation. Symptoms and signs may progress
adverse effect on the fetus) and are therefore
rapidly, with some affected patients developing
relatively contraindicated in pregnant patients.
contractures and joint immobility. Occasionally,
These agents pass through the placental barrier
the disease may be fatal. There is no known
and enter the fetal circulation. They are then
effective treatment.
filtered by the fetal kidneys and excreted into
the amniotic fluid, where they may remain for a NSF occurs nearly exclusively in patients with
prolonged period. Prolonged presence of the severe CKD (eGFR < 30 mL/min/1.73 m2) or in
agent in the amniotic fluid could theoretically patients with AKI who have been exposed to
increase the risk of dissociation from the chelate GBCM. Symptom onset can occur from days to

2025 Noninterpretive Skills Study Guide 47

years after GBCM administration. Identification and infection. Unfortunately, no consistent
of the GBCM responsible for the precipitation relationship between these factors and NSF has
of this disease is sometimes difficult, because been identified.
many patients have received multiple different
The mechanism of NSF is unknown, although
MR contrast agents. GBCM agent exposure is
many experts have speculated that it may result
considered to be “confounded” in patients with
from dissociation of the gadolinium ion from its
NSF who have been exposed to multiple
chelate in vivo, with subsequent precipitation
GBCM; the exposure is considered to be
of gadolinium in tissue. This mechanism has
“unconfounded” when a patient with NSF has
been suggested because the three high-risk
only been exposed to one agent.
GBCM have lower stability of gadolinium ion
NSF has been encountered almost exclusively binding to the chelate than do most of the
after patient exposure to several specific linear nonimplicated GBCM. With high-risk GBCMs,
GBCM, with the high-risk agents being a different ion is thought to be able to replace
gadodiamide (Omniscan®), gadoversetamide the gadolinium ion within the chelate more
(OptiMark®, no longer manufactured), and easily, thereby freeing up the toxic gadolinium
gadopentetate dimeglumine (Magnevist®). atom. This replacement process is referred to as
Higher doses and multiple doses of the higher transmetallation.
risk GBCM are believed to increase the
In response to the emergence of NSF,
likelihood of NSF, although cases have
radiologists have instituted a number of
occurred after only a single administration of a
precautions that have been effective in nearly
standard dose of GBCM.
eliminating this disease. The most important
Few, if any, cases of unconfounded NSF have precaution is avoiding the high-risk GBCM
been reported with the lower-risk agents, which (gadodiamide [Omniscan®], gadoversetamide
include gadobenate dimeglumine [OptiMark®], and gadopentetate dimeglumine
(MultiHance®), gadobutrol (Gadavist®), [Magnevist®]) in any patients requiring
gadoterate meglumine (Dotarem® and contrast- enhanced MRI who might have severe
Clariscan®), and gadoteridol (ProHance®). CKD (eGFR < 30 mL/min/1.73 m2) or AKI. At
Gadoxetate disodium (Eovist®) is a newer agent institutions where high-risk GBCM are used,
with limited information about its association patients referred for contrast-enhanced MRI
with NSF; however, the risk of NSF developing should be screened for renal disease (which
after gadoxetate disodium administration is may include obtaining eGFR levels in any
probably very low. patient with a history of a solitary kidney,
kidney transplant, or renal neoplasm; or
Because most patients with severe CKD who
hypertension or diabetes mellitus). The three
are exposed to NSF-associated GBCM do not
high-risk GBCM are absolutely contraindicated
develop NSF, other factors are believed to be
by the Food and Drug Administration when the
required for disease development. Additional
eGFR is less than 30 mL/min/1.73 m2.
suggested risk factors for NSF have included
metabolic acidosis or medications that There is no proof that immediate post-MRI
predispose patients to acidosis; increased iron, dialysis reduces the risk of NSF in any high-risk
calcium, and/or phosphate levels; high-dose GBCM- exposed patients.
erythropoietin therapy; immunosuppression;
vasculopathy; an acute pro-inflammatory event;

2025 Noninterpretive Skills Study Guide 48

Gadolinium Retention The examining radiologist should quickly
determine the level of patient consciousness,
Some administered gadolinium remains in the
the appearance of the skin, the quality of
body after GBCM administration. It has long
phonation, and the presence or absence of
been known that this retention occurs in the
respiratory and cardiovascular symptoms.
skeleton and is greater with linear than
macrocyclic agents. Mild reactions usually resolve within 20 to 30
minutes and do not require medical treatment;
More recently, investigators have found that
however, some patients with moderate and
gadolinium is also retained within the brain
severe reactions may initially develop only
(particularly in the globus pallidus and dentate
mild symptoms. For this reason, all patients
nucleus). This occurs even in patients with
should be monitored until their symptoms have
normal renal function. The amount of
improved.
gadolinium accumulation is proportional to the
amount of GBCM that a patient has received. It The management of a contrast reaction depends
is not clear in what state the gadolinium is on the nature of the reaction and its severity.
retained. As with retention in the bones, Treatments recommended in the ACR Manual
retention in the brain is greater with linear than on Contrast Media (2020) for different types of
with macrocyclic agents. reactions in adults are condensed and
summarized below.
There is no evidence of any adverse neurologic
effects of this accumulation (even after millions Hives (Urticaria)
of GBCM administrations throughout the
• No treatment is needed in most cases.
world); however, further study is necessary to
determine long-term effects, if any, that • If symptomatic, administer
gadolinium deposition in the brain may have. diphenhydramine (Benadryl®), 25 to 50
mg orally (PO), intra- muscularly (IM),
4.2.3 Treatment of Acute Contrast Reactions
or intravenously (IV). Alternatively, use
When an allergic-like reaction occurs, rapid fexofenadine (Allegra®), 180 mg PO.
recognition, patient assessment, and diagnosis
Diffuse Erythema
are important so that appropriate treatment can
be instituted rapidly. • Preserve IV access, monitor vitals, and
use a pulse oximeter.
A responding radiologist should assess the
patient quickly. A brief discussion with the • Give O2, 6 to 10 L/min (via mask).
patient and any present healthcare providers, • If the patient is normotensive, no further
when possible, should provide the following treatment is usually needed; note that
information: the reason for the imaging study, a antihistamines should be administered
description of the patient’s current symptoms, with caution, as they may exacerbate
and a summary of the patient’s health problems existing or developing hypotension.
and medications. Vital signs should be obtained
• If the patient is hypotensive, give 1 L of
promptly. IV access should be secured. A pulse
IV fluids rapidly, either 0.9% normal
oximeter should be available. Oxygen should
saline or Lactated Ringer’s solution.
also be available and, if administered, should
be given at high doses. • If hypotension is profound or does not
respond to IV fluids, consider

2025 Noninterpretive Skills Study Guide 49

 epinephrine IV (1 mg/ 10 mL) adding epinephrine IM (1 mg/mL)
(1:10,000), 1 mL (0.1 mg) slowly into a (1:1000), 0.3 mL (0.3 mg), or IM EpiPen
running infusion of IV fluids. Repeat as or equivalent (0.3 mL, 1 mg /mL 1:1000
needed at 5- to 10-minute intervals up to dilution fixed), or epinephrine IV (1
10 mL total. In the absence of IV access, mg/10 mL) (1:10,000), 1 mL (0.1 mg)
consider epinephrine IM (1 mg/mL) slowly into a running infusion of IV
(1:1000), 0.3 mL (0.3 mg), or IM EpiPen fluids.
or equivalent (0.3 mL, 1:1000 dilution • Repeat epinephrine as needed up to a
fixed). IM epinephrine may be repeated
maximum of 1 mg.
up to 1 mg total.
• Consider calling an emergency response
• Consider calling an emergency response
team or 911 based on the completeness of
team or 911 based on the severity of the
patient response to treatment.
reaction and the completeness of patient
response to treatment. Hypotension, Any Cause (systolic blood pressure <
90 mm Hg)
Laryngeal Edema
• Preserve IV access, monitor vitals, and
• Preserve IV access, monitor vitals, and
use a pulse oximeter.
use a pulse oximeter.
• Elevate legs at least 60 degrees
• Give O2, 6 to 10 L/min (via mask).
(Trendelenburg position).
• Give epinephrine IM (1:1000), 0.3 mL
• Give O2, 6 to 10 L/min (via mask).
(0.3 mg), or IM EpiPen or equivalent (0.3
mL, 1:1000 dilution fixed), or, especially • Consider rapid administration of 1 L of
if hypotensive, epinephrine IV IV fluids, 0.9% normal saline or Lactated
(1:10,000), 1 mL (0.1 mg) slowly into a Ringer’s solution.
running infusion of IV fluids. Hypotension with Bradycardia (pulse < 60 bpm)
• Repeat epinephrine as needed up to a (Vagal Reaction)
maximum of 1 mg. • If mild, no additional treatment is
• Consider calling an emergency response usually needed beyond that listed
team or 911 based on the severity of the above for any cause of hypotension.
reaction and the completeness of patient • If severe (patient remains unresponsive
response to treatment to above measures), give atropine, 0.6
Bronchospasm to 1.0 mg IV, into a running infusion of
IV fluids. (Note: lower doses of
• Preserve IV access, monitor vitals, and
atropine may exacerbate bradycardia.)
use a pulse oximeter.
• May repeat atropine up to a total dose
• Give O2, 6 to 10 L/min (via mask).
of 3 mg.
• Give beta-agonist inhaler albuterol, 2
• Consider calling an emergency
puffs (90 mcg per puff); can repeat up to
response team or 911.
three times. In cases in which
bronchospasm is severe and/or
unresponsive to an inhaler, consider

2025 Noninterpretive Skills Study Guide 50

Hypotension with Tachycardia (pulse > 100 bpm) department.
(Allergic-like Reaction)
• Give hydrocortisone, 5 mg/kg IV over
• If hypotension persists after the basic 1 to 2 minutes ,or methylprednisolone,
treatment listed above for any cause of 1 mg/kg IV over 1 to 2 minutes.
hypotension, give epinephrine IV (1
Hypertensive crisis, pulmonary edema,
mg/10 mL) (1:10,000), 1 mL (0.1 mg)
seizures or convulsions, and hypoglycemia are
slowly into a running infusion of IV
uncommon reactions. If these occur, the
fluids. Can repeat as needed up to 10
radiologist should refer to standard treatment
mL (1 mg) total. Alternately, IM
sources, including the ACR Manual on Contrast
epinephrine (1 mg/mL) (1:1000) could
Media.
be given, 0.3 mL (0.3 mg), or IM
EpiPen or equivalent (0.3 mL, 1 mg/mL Pediatric Dosing
1:1000 dilution fixed). IM epinephrine Pediatric dosing for some of the
may be repeated up to 1 mg total. interventions/medications utilized for treating
• Consider calling an emergency allergic-like contrast reactions are provided as
response team or 911 based on the follows:
severity of the reaction and the • Isotonic fluid: 10-20 mL/kg of 0.9%
completeness of patient response to normal saline or Lactated Ringers up to
treatment. a maximum volume of 500-1,000 mL
Unresponsive and Pulseless • Diphenhydramine (Benadryl ®): 1
• Check for responsiveness. mg/kg up to a maximum of 50 mg

• Activate emergency response team or • Beta agonist inhaler (Albuterol ®): 2

call 911. puffs (90 mcg/puff) for a total of 180
mcg; can repeat up to three times
• Perform CPR per American Heart
Association protocols. • Epinephrine:

• Defibrillate as indicated if equipment o IM dosing: (up to 30 kg):

is available. epinephrine autoinjector (EpiPen
• May administer epinephrine IV 1 Jr®) single dose of (0.15 mg)
mg/10 mL) (1:10,000), 10 mL (1 mg), o IM dosing: (over 30 kg patient
between 2-minute cycles of CPR. weight): use adult autoinjector; or
Reaction Rebound Prevention 0.01 mL/kg (0.01 mg/kg) of 1
mg/mL or 1:1000 dilution
• IV corticosteroids are not useful in
acute treatment of any reaction. (maximum single dose of 0.3 mL
[0.3 mg]); repeated every 5-15
• However, IV corticosteroids help
minutes needed up to a
prevent a short- term recurrence of an
maximum dose of 1 mg (1 mL)
allergic-like reaction and may be
considered for a patient having a o IV dosing: 0.1 mL/kg (0.01
severe allergic-like reaction before mg/kg) of 1 mg/10 mL or 1:10,000
transportation to the emergency

2025 Noninterpretive Skills Study Guide 51

 dilution (maximum single dose of 7. Landigran C. Preventable deaths and
1 mL [0.1 mg]), repeated every 5 injuries during magnetic resonance
– 15 minutes, as needed up to a imaging. N Engl J Med 2001;345:1000-1001.
maximum dose of 1 mg (10 mL) 8. Lasser EC, Berry CC, Mishkin MM,
Williamson B, Zheutlin N, Silverman JM.
Pretreatment with corticosteroids to prevent
References adverse reactions to nonionic contrast
1. American College of Radiology. ACR media. AJR Am J Roentgenol 1994
Manual on Contrast Media (version 10.3). Mar;162(3):523-526.
American College of Radiology Website. 9. Nordbeck P, Ertl G, Ritter O. Magnetic
https://www.acr.org/Clinical- resonance imaging safety in pacemaker and
Resources/Contrast-Manual. Accessed June implantable cardioverter defibrillator
13, 2018. Greenberger PA, Patterson R. The patients: how far have we come? Eur Heart J
prevention of immediate generalized 2015;36(24):1505-1511.
reactions to radiocontrast media in high-
10. Tsai LL, Grant AK, Mortele KJ, Kung JW,
risk patients. J Allergy Clin Immunol. 1991
Smith MP. A Practical Guide to MR
Apr;87(4):867-872.
Imaging Safety: What Radiologists Need to
2. Greenberger PA, Patterson R. The Know. Radiographics 2015 Oct;35(6):1722-
prevention of immediate generalized 1737.
reactions to radiocontrast media in high-
11. Maloney E, Iyer R, Phillips GS, Menon S,
risk patients. J Allergy Clin Immunol. 1991
Lee JJ, Callahan MJ. Practical administration
Apr;87(4)867-872.
of intravenous contrast media in
3. ACR Manual on MR Safety children: screening prophylaxis,
https://www.acr.org/- administration and treatment of adverse
/media/ACR/Files/Radiology-Safety/MR-
reactions. Pediatr Radiol 2019; 49:433-
Safety/Manual-on-MR-Safety.pdf
44.7
4. Kanal E, Gillen J, Evans JA, et al. Survey of
12. Mervak BM, Cohan RH, Ellis JH, Khalatbari
reproductive health among female MR
S, Davenport MS. Intravenous
workers. Radiology 1993;187:395-399.
corticosteroid premedication
5. Klucznik RP, Carrier DA, Pyka R, et al. administered 5 hours before CT
Placement of a ferromagnetic intracerebral
compared with a traditional 13-hour
aneurysm clip in a magnetic field with a
oral regimen. Radiology 2017; 285:425-
fatal outcome. Radiology 1993;187:855-856.
433.
6. Klucznik RP, Carrier DA, Pyka R, et al.
Placement of a ferromagnetic
intracerebral aneurysm clip in a
magnetic field with a fatal outcome.
Radiology 1993;187:855-856.

2025 Noninterpretive Skills Study Guide 52

Chapter 5: Reimbursement, Regulatory Compliance, and
Legal Considerations in Radiology

5.1 Reimbursement and Regulatory The CPT Editorial Panel is composed of

Compliance physicians nominated by national medical
societies, CMS, and other industry leaders. A
5.1.1 Coding, Billing, and Reimbursement
separate committee, the AMA CPT Advisory
Appropriate reimbursement for healthcare Committee, assists the CPT Editorial Panel by
services involves a series of complex and making recommendations regarding new
interconnected steps that often vary depending codes and existing codes. The CPT Advisory
on the payer. A number of generalizable Committee is composed of representatives
principles based on Medicare rules should nominated by national medical societies. For
guide best practice efforts to optimize revenue example, national radiology societies designate
and compliance activities. These principles of representatives to serve on the CPT Advisory
reimbursement are also important to Committee who then advocate for radiologists
understand as they often serve as the basis for by making recommendations for new or
how third-party payors structure their existing radiology CPT codes.
reimbursement. Traditionally, physician
Each CPT code is assigned a value called the
services and procedures are reimbursed on a
Relative Value Unit (RVU) based on the
fee-for-service basis. Although this fee-for-
Resource Based Relative Value Scale. This value
service system of reimbursement forms the
is relative in that each value reflects its relative
basis for physician reimbursement today, it is
value compared to other services or procedures
important to recognize that especially with
within the specialty as well other medical
primary care models, there is a clear shift away
specialties. The AMA RBRVS Update
from a volume-based form of reimbursement
Committee (also known as “The RUC”), makes
(i.e., fee-for -service) towards more value-based
recommendations to CMS for RVU valuation
payments requiring attainment of certain
for each CPT code, and is predominantly
quality measures.
composed of physicians representing various
Each service or procedure that a physician medical societies. The AMA RUC Advisory
provides is given a unique code called a Committee, supports the RUC by making
Current Procedural Terminology code (CPT) recommendations just as the CPT Advisory
that in turn is assigned a specific Committee supports the CPT Editorial Panel.
reimbursement amount. The first step in National medical societies can nominate
obtaining reimbursement for a new service or representatives to the RUC Advisory
procedure is to have it assigned a unique CPT Committee who then advocate for their
code. The American Medical Association membership by recommending specific RVU
(AMA) CPT Editorial Panel, is responsible for valuations to the RUC, which in turn makes its
maintaining the CPT code set, including final recommendations to CMS.
authorizing new codes, modification of existing
Each service or procedure’s total RVUs reflect
codes, and deletion of codes no longer relevant.
the amount of 1) encounter time, intensity,

2025 Noninterpretive Skills Study Guide 53

effort, and skill (the work RVU); 2) costs of service. Terms such as “rule out” or “consistent
maintaining a practice, such as equipment, with” are not capable of being coded by ICD-10,
supplies, and nonphysician staff (practice and therefore do not meet medical necessity
expense RVU); and 3) professional liability criteria.
expenses (malpractice RVU). Work RVU is used
Reimbursement for radiology services is largely
by many practices to track physician
predicated on the adequacy of documentation
productivity. Although the Centers for
within the physician report. Professional
Medicare and Medicaid Services (CMS)
coders, assisted by software tools, extract
ultimately sets the valuation of RVUs, it has
information from radiology reports to assign
historically accepted the AMA RUC
both ICD-10 and CPT codes. The Radiology
recommendations in the vast majority of cases.
Coding Certification Board is the primary
Once an RVU is determined for a specific organization that credentials professional
service or procedure designated by its CPT medical imaging coders. These individuals
code, a multiplier called the Conversion Factor extract ICD-10 information from radiology
(CF) is used to determine the actual reports using any statements 1) about
reimbursement. Thus, to obtain the actual examination indication and clinical history
reimbursement for a specific procedure, the provided by the referring physician or patient
RVU for that procedure is multiplied by the CF. and 2) from any specific diagnostic information
located in the findings section or (preferably) in
Payment = RVU x CF
the impression section of the radiologist’s
The conversion factor is set annually by CMS in report. CPT codes are assigned based on the
Final Rule of the Medicare Physician fee specific details of the described service. For
schedule. For example, the CF for 2020 was set radiography, more views generally translate to
by CMS at $36.09 and in 2021 this fell to $34.89. higher complexity codes. For ultrasound, organ
CMS and private insurers generally pay only inventory “checklists” apply to abdominal,
for services deemed medically necessary. CMS pelvic, obstetrical, and extremity imaging. For
defines medical necessity as “healthcare CT and MRI, details of contrast administration
services or supplies needed to prevent, (i.e., without, with, or without and with
diagnose, or treat an illness, injury, condition, contrast) determine the CPT code for a specific
disease, or its symptoms and that meet body part. Structured template reporting helps
accepted standards of medicine.” In radiologists comply with many of these
practicality, the determination of medical reporting requirements, facilitating appropriate
necessity is usually a rules- based reimbursement and regulatory compliance.
administrative exercise performed at the time a Many private payers, Medicaid plans, and
claim is submitted to a payer, wherein a CPT Medicare Advantage (i.e., not traditional
service code must match a pre-approved Medicare indemnity) payers contract with
diagnosis code list. Those diagnosis codes must radiology benefit management (RBM)
be in the form of the International Classification of companies, and require preauthorization (also
Diseases (ICD) system, established by the World known as precertification) as a condition for
Health Organization, currently in its 10th reimbursement for any elective outpatient
revision (ICD-10). ICD-10 codes describe the advanced imaging service. Before performing
signs, symptoms, or specific diagnosis of a advanced imaging services such as CT, MRI,
patient that form the indication for a healthcare

2025 Noninterpretive Skills Study Guide 54

and PET/CT, radiology facilities should government from being overcharged or sold
determine whether preauthorization is required substandard goods or services. A false claim is
for a particular service for a particular patient generally defined as a request for payment for
and, if so, whether such preauthorization has services that a provider knew or should have
been obtained. Although a necessary condition known was false or fraudulent. While the U.S.
for payment, preauthorization by an Department of Justice does not expect
outsourced RBM does not always guarantee a physicians to be experts in all of these nuanced
subsequent favorable medical necessity matters, it has set an expectation that radiology
determination by the insurer itself when a claim practice processes, structures, and cultures be
is filed. As a general rule, preauthorization oriented toward optimizing the integrity of
requirements do not apply to emergency revenue cycle operations. Best practice
department and inpatient services. techniques call for formal compliance plans,
with a formally designated compliance officer
The consultation of software for imaging
and compliance committee appropriately
Clinical Decision Support software (CDS) is
empowered to oversee these activities. A false
technically required for all Medicare outpatient
claim ruling can result in fines of up to three
and certain ED patients when ordering
times the billed amount plus $11,000 per claim
advanced imaging tests (CT, MRI, and Nuclear
filed, because each single exam or service billed
Medicine), although payment consequences
to Medicare or Medicaid counts as a claim. In
have not yet been defined. This software
2014, the largest radiology practice settlement
further scores appropriateness of imaging
occurred for $15.5 Million based upon
orders in 8 clinical priority conditions;
allegations at a diagnostic testing facility that it
Coronary artery disease (suspected or
falsely billed federal and state health care
diagnosed), Suspected pulmonary embolism,
programs for tests that were not performed or
Headache (traumatic and nontraumatic), Hip
not medically necessary and paid kickbacks to
pain, Low back pain, Shoulder pain (including
physicians. Multi-million dollar settlements
suspected rotator cuff injury), cancer of the
occur almost annually with $5 million being
lung (primary or metastatic, suspected or
paid in 2020 to resolve allegations of
diagnosed) and cervical or neck pain. These
unsupervised radiology services and services
initial 8 clinical priority conditions were
provided at unaccredited facilities.
designated by the CMS in 2016 with scores now
being transmitted on provider claims. The list is 5.1.2 Patient Privacy and HIPAA
likely to grow in future years after the initial
Respect for patient privacy is a core
operations testing period. These software
responsibility of a medical professional. The
systems are to use appropriate imaging
Privacy and the Security rules of the Health
recommendations from Qualified Provider Led
Insurance Portability and Accountability Act of
Entities (QPLEs) which include national
1996 (HIPAA) represent a codification of this
medical societies. The intent is to guide
principle in the law. They provide a set of
ordering physicians to the most appropriate
national privacy standards and bring with them
studies for their patients, and this approach is
the power of law. As such, compliance activities
being attempted by CMS as an alternative to
must prioritize patient privacy. HIPAA rules
the pre-authorization process.
apply to healthcare providers, plans, and
The False Claims Act (FCA) protects the clearinghouses alike.

2025 Noninterpretive Skills Study Guide 55

The Privacy Rule establishes national standards authorization. Exceptions include information
for the protection of individually identifiable disclosed or transmitted when necessary for 1)
health information, referred to as protected the delivery of care or treatment, 2) payment
health information (PHI). The Security Rule activities, and 3) healthcare operations
establishes a national set of security standards involving quality or competency assurance,
for securing PHI when held or transferred in fraud or abuse detection, or compliance. In
electronic form. It operationalizes the addition, when required by law, information
protections contained in the Privacy Rule by can be released 1) to public health authorities,
addressing both technical and nontechnical 2) during investigation of abuse, neglect, or
safeguards that organizations must put in place domestic violence, 3) to oversight agencies, 4)
to secure individuals’ electronic PHI (e-PHI). for judicial and administrative proceeding, 5)
Within the U.S. Department of Health and for law enforcement purposes, and 6) for
Human Services, the Office for Civil Rights worker’s compensation.
(OCR) has responsibility for enforcing these
5.1.3 Human Subjects Research
rules with civil money penalties.
Properly controlled biomedical research
The major goals of the HIPAA rules are to
involving human subjects is essential to
assure appropriate protection of each
advancing medical knowledge and care.
individual’s PHI while still permitting the flow
Unfortunately, human cruelty has occasionally
of information necessary to provide and
been perpetrated in the name of research, and
promote quality healthcare. The following
not all human studies have been either
identifiers are included in the definition of PHI:
justifiable or useful. The discoveries of such
1) names; 2) geographic subdivisions smaller
abuses during Nazi Germany were the basis for
than a state (except for the first three digits of a
the development of the Nuremberg Code,
ZIP code representing a population greater
which represented the first international
than 20,000); 3) all elements of dates (except
codification of minimal expectations for the
year) related to an individual, such as birthdate,
conduct of ethical research involving human
admission date, discharge date, and date of
subjects. The Code’s most important principles
death; 4) phone numbers; 5) fax numbers; 6)
were that experiments involving human
email addresses; 7) Social Security numbers; 8)
subjects should occur only with subjects who
medical record numbers; 9) health plan
have freely chosen to participate, and in the
beneficiary numbers; 10) account numbers; 11)
context of a clear scientific rationale. The
certificate and license numbers; 12) vehicle
subsequent Declaration of Helsinki, now
identification and license plate numbers; 13)
widely regarded as the cornerstone of human
device identifiers and serial numbers; webpage
research ethics, has recommended that all
universal resource locators (URLs); Internet
research protocols be reviewed by an
Protocol (IP) addresses; 16) biometric identifiers
independent committee prior to initiation.
such as finger- and voice-prints; 17) full face or
similar photographs; and 18) any other unique That recommendation led to the development
identifier, characteristic, or code. of the Institutional Review Board (IRB) system
currently in place in the United States, wherein
As a general rule, an individual’s PHI cannot be
appropriately constituted groups, usually at the
disclosed or transmitted to anyone other than
university or health system level, are formally
the individual without that individual’s
designated to review and monitor biomedical

2025 Noninterpretive Skills Study Guide 56

research involving human subjects. In protocol review when a project constitutes a
accordance with Food and Drug quality improvement activity, as long as the
Administration (FDA) regulations, an IRB has primary objective is to improve local practice
the authority to approve, require modifications rather than to create generalizable knowledge.
in order to secure approval, or deny approval IRB approval is not required for studies that do
for proposed research protocols. These review not meet federal definitions of human subjects
groups serve important roles in the protection research (e.g., studies that utilize open source
of the rights and welfare of human research public datasets).
subjects.
IRBs are required to ensure a “diversity of
5.2 Malpractice and Risk Management
members, including consideration of race,
gender, cultural backgrounds, and sensitivity to 5.2.1 General Principles of Malpractice
such issues as “community attitudes” and to Malpractice fears have been cited as a cause of
register with the Department of Health and physician burnout and distress, including in
Human Services (HHS). Institutions engaged in radiology.
research involving human subjects usually have Approximately 7% of all radiologists are named
their own IRBs to oversee research conducted in a medical malpractice lawsuit each year;
within the institution or by its staff. However, radiology indemnity payments in malpractice
institutions without an IRB are permitted to cases average approximately $480,000. The
arrange for an outside IRB to assume oversight average radiologist spends approximately 19
responsibilities. months of his or her career with an unresolved
Because the free choice of research subject open malpractice claim. Malpractice concerns
participation is a fundamental prerequisite to have also been identified as a cause of
ethical research, an IRB carefully scrutinizes all overutilization of services; more than 90% of
aspects of consent. The research informed physicians report that they at least sometimes
consent process involves 1) providing adequate engage in the practice of defensive medicine.
information about a study to potential subjects, Malpractice insurance coverage is usually
2) providing an adequate opportunity for mandated as a condition of state licensure and
subjects to consider all options, 3) responding hospital credentialing. “Claims-made” policies
adequately to all subject questions, 4) ensuring are the most common types of policies and
that the subject comprehends all necessary protect physicians from personal financial
information, 5) obtaining the subject’s liability, up to a predetermined policy cap, but
voluntary agreement to participate, and 6) only while the policy is in effect. Physicians
providing ongoing information as the subject or with claims- made policies thus usually need to
situation so requires. In some situations (such arrange for tail insurance when changing jobs
as many studies involving the retrospective or retiring to ensure continued financial
review of imaging), an IRB may waive the protection. “Occurrence” policies cover any
requirement for informed consent when the claim for an event that took place during the
research involves no more than minimal risks period of coverage, even if a claim is filed after
to participants, and cannot be practically the policy lapses.
carried out without such a waiver. IRBs
typically provide an exemption from formal Medical malpractice lawsuits are based on the
tort of negligence, and require four elements:

2025 Noninterpretive Skills Study Guide 57

1. The physician must have an established errors in diagnosis. Depending on the clinical
duty to a patient. For example, duty indication and modality, the sensitivity of
would exist for a radiologist to provide imaging in detecting disease is highly variable,
treatment for a patient undergoing a and plaintiff lawyers frequently contend that
any false negative interpretation represents
contrast reaction in the radiology
medical negligence. In considering a chest
department but not for interpreting the
radiograph with missed lung cancer, for
contents of a CT scan on a CD in a example, as many as 90% of cancers are
patient’s purse in her ICU room unless identifiable in retrospect; a radiologist’s
those images were submitted for formal potential legal exposure is not insignificant.
review under established hospital Hindsight bias represents the tendency for
policy. people with a knowledge of the actual outcome
of a case to believe falsely that they would have
2. There must have been a breach of duty,
predicted its outcome. This jury bias makes
which usually involves a failure to meet
defending such cases difficult.
the standard of care. The definition of
standard of care varies by jurisdiction, Negligent diagnosis claims can be categorized
as related to 1) failures of perception (i.e., not
but is generally how a reasonable,
identifying a finding), 2) failures of
prudent, or ordinary physician of a
interpretation (i.e., identifying a finding but not
similar specialty would have acted in appropriately appreciating or adequately
similar circumstances. communicating its significance), or 3)
3. Causation must exist, in that the breach combinations of both. Diagnostic errors can also
must have been the proximate cause of be categorized as 1) cognitive errors (e.g., not
injuries. A radiologist, for example, may identifying a lung nodule when interpreting a
chest radiograph), which are usually errors of
have negligently missed a lung mass on
visual perception (scanning, recognition, and
a chest radiograph, but establishing that
interpretation), or 2) system errors (e.g., failure
as the proximate cause of a hemorrhagic to adequately communicate the presence of that
stroke the next day would be difficult. nodule), which are usually attributed to health
4. The negligence must result in damages. system issues or context of care delivery
In many jurisdictions, emotional problems.
distress, pain, and suffering are As in other medical disciplines, errors in
frequently considered remunerative diagnosis in radiology often result from a
damages. combination or interaction between cognitive
and system errors, such as preliminary reports
Claims of negligence against radiologists
by residents that are revised in a final report
generally fall into 3 categories: 1) diagnostic
but not fully communicated to care teams.
errors, 2) procedural complications, and 3)
Certain system factors, such as lighting
communication deficiencies.
conditions, shift length, or pace of
5.2.2 Malpractice Related to Diagnostic Errors interpretation, have been shown to increase the
likelihood of diagnostic errors. Enhanced
The most common cause of malpractice
awareness of these types of errors helps
lawsuits against radiologists is for alleged

2025 Noninterpretive Skills Study Guide 58

radiologists identify areas of diagnostic procedure also helps set realistic expectations.
vulnerability and institute interventions to The doctrine of informed consent has been
improve patient care and mitigate their own codified in the U.S. courts as a basic right of
potential risks. self-determination: “Any human being of adult
years and sound mind has a right to determine
5.2.3 Malpractice Related to Procedural
what shall be done with his body; and a
Complications
surgeon who performs an operation without his
Any invasive procedure has a risk of patient’s consent commits an assault.” Courts
complication. Such complications vary in type have subsequently expanded that decision to
and severity based on the procedure, and can apply to procedures other than open operations
similarly serve as the grounds for medical and those performed by nonsurgeon
negligence claims. Despite what some plaintiff physicians. Necessary elements of informed
lawyers might contend, complications by consent are described in Section 3.2.1 of this
themselves do not indicate negligence. study guide. Although most hospitals have
Lawsuits based on procedural complications, standard consent forms in place, additional
however, are more successfully argued in detailed documentation in procedure reports
scenarios in which a radiologist did not exercise may prove helpful in a claim of negligence.
appropriate care in 1) minimizing the risk of the
5.2.4 Malpractice Related to Communications
complication, 2) identifying complication once
Deficiencies
it occurred, or 3) treating the complication. In
the instance of the very common complication Appropriate communication of actionable
of pneumothorax after a lung biopsy, for information from radiologists to clinical
example, a radiologist’s malpractice risk would caregivers is a critical component of patient
increase if he or she 1) used an overly large care. Both courts and regulatory agencies are
needle or chose a trajectory unnecessarily increasingly holding radiologists to higher
crossing an aerated lung, 2) did not obtain a standards of ensuring prompt communication
postprocedural chest radiograph, or 3) of diagnostic information. In fact, a number of
discharged the patient to home in the setting of court decisions have focused not only on a
an enlarging pneumothorax. radiologist’s duty to communicate important or
critical findings with referring physicians, but
Patients and their families are more likely to
also on communications with patients
sue physicians for damages related to
themselves when their treating physicians may
complications if they believe that details of their
not be available.
care were withheld. As a result, most risk
managers advocate full and prompt disclosure Routine Communication
of any untoward events, and ongoing
In radiology, routine communication refers to
communication about decision-making and
the creation and delivery of written reports. The
treatment. Detailed and contemporaneous
ACR Practice Parameter for Communication of
documentation of events, discussions, and
Diagnostic Imaging Findings outlines
rationale for decisions in the radiology report
suggested formatting for reports, which
and/or elsewhere in the medical record may
includes relevant demographic information
prove helpful in court.
(e.g., patient name and identifying information,
Engaging patients (and their families, when referring physician, facility information),
appropriate) in decision-making before a examination details (e.g., type and time of

2025 Noninterpretive Skills Study Guide 59

examination including contrast administration practice environment (e.g., by a trainee in a
information, time of dictation), and report teaching institution or by a general practice
content recommendations (e.g., findings, radiologist when a subspecialist radiologist is
impressions, limitations, complications). It is not immediately available). Such preliminary
acceptable for demographic information and communications should be archived, since they
examination details to be contained in the may have served as the basis of immediate
metadata associated with the report (rather clinical decisions. Institutions are expected to
than in the dictated report body itself). maintain policies for reconciling discrepancies
Radiology reports are now typically generated between preliminary and final reports and for
and transmitted electronically. discrepancies encountered upon subsequent
review of a final report. Any clinically
The final report represents the definitive
significant variation in findings or impression
documentation of the results of an imaging
between a preliminary and final interpretation
examination or procedure. It should be
should be clearly documented and reported as
proofread to minimize typographical errors and
soon as possible and in a manner that ensures
confusing or conflicting statements. The use of
receipt by the ordering or treating physician.
abbreviations or acronyms should be limited to
avoid ambiguity. The final report should be Clinical situations that may warrant nonroutine
completed in accordance with all appropriate communication include the following:
state and federal requirements (e.g.,
1. Findings that warrant immediate or urgent
Mammography Quality Standards Act). A copy
intervention. These are generally new or
of the final report should be archived by the
unexpected findings on an imaging study
imaging facility as part of the patient’s medical
that suggest life-threatening conditions or
record and be retrievable for future reference.
those that may require an immediate
Retention and distribution must be in
change in patient management. Aside from
accordance with all state and federal
risk management imperatives, The Joint
regulations and facility policies.
Commission (TJC) requires that
Nonroutine Communication professionals “report critical results of tests
and diagnostic procedures on a timely
While routine communication is typically
basis.” TJC-accredited facilities are required
carried out through institutionally established
to define critical tests and critical results
final reporting mechanisms, certain
and monitor performance in reporting those
circumstances dictate alternative
results. A critical result is defined as “any
communication mechanisms to ensure timely
result or finding that may be considered life
receipt of important diagnostic information.
threatening or that could result in severe
These include situations warranting
morbidity and require urgent or emergent
preliminary reports and results of an urgent or
clinical attention.” Examples include
other significantly important nature.
tension pneumothorax, ruptured aortic
Occasionally, a preliminary report is issued aneurysm, acute intracerebral hemorrhage,
before the final report, and may be rendered for and pneumoperitoneum. Each facility has
the purpose of directing immediate patient leeway in defining its own critical tests and
management (e.g., when old comparison critical results; there is no standard list for
images are not yet available but reporting either category. For all critical results,
cannot wait) or to meet the needs of a particular

2025 Noninterpretive Skills Study Guide 60

 communication requires direct contact electronically when electronic messaging
between the radiologist and the requesting tracking mechanisms are in place to make
or responding clinician or another licensed sure that information was successfully
healthcare provider responsible for that received and, when necessary,
patient’s care. In addition, communication supplemented by telephone confirmation.
is generally expected to occur within 60
Documentation of all nonroutine
minutes of the time that the observation is
communication should include the date and
made, and it must be documented. When
time of the communication, the person
the ordering physician or healthcare
reporting the information, the person receiving
provider cannot be contacted expeditiously,
the information, and a summary of or reference
it may be appropriate to convey results
to the information that was conveyed.
directly to the patient, depending on the
nature of the findings. At some institutions, Informal Communication
these critical results are deemed “Level 1 Radiologists may occasionally be asked to
results.” provide interpretations that do not result in a
2. Findings that may not require immediate formal report but are nonetheless used to make
attention but nonetheless may seriously treatment decisions.
impact a patient’s health, worsen over Such communications may take the form of a
time, or result in an adverse outcome. “curbside consult” that may occur informally in
These include the following: 1) New or the reading room or during a clinical
unexpected findings that could result in conference. These circumstances often preclude
mortality or significant morbidity if not immediate documentation and may also occur
treated in a timely manner. Referred to as in suboptimal viewing conditions (e.g., no
“Level 2 results” by some institutions, these comparison studies, no original reports, or
are less dire than critical results and inadequate incomplete history). Informal
generally warrant communication within 12 communications carry additional inherent risk
hours. For such findings, the radiologist since the documentation of the clinician
might call the care team directly, or might initiating the informal consultation may
request a call service or assistant to call on constitute the only written record of that
his or her behalf. Examples include intra- communication. For these reasons, informal
abdominal abscess or impending communications are largely discouraged; when
pathological hip fracture. 2) New or such communications do occur, radiologists
unexpected findings on an imaging study should document them independently from the
that could result in significant but not referring clinician’s documentation.
immediate morbidity if not appropriately
Radiology departments are encouraged to
treated. Deemed “Level 3 results” by some
institutions, communication is not establish processes and policies for reporting
studies performed at outside institutions.
particularly time sensitive but mechanisms
Radiologists who provide consultations of this
must be in place to ensure that these
nature are encouraged to document any
important or potentially important findings
information conveyed, including formal
are not overlooked. Examples include a
newly identified lung nodule or solid renal interpretations. Although formal second
mass. These findings may be reported opinion interpretations are historically non-

2025 Noninterpretive Skills Study Guide 61

payable, Medicare and private payers are
increasingly reimbursing radiologists for them
References
when they are medically necessary and are
billed in accordance with payer rules. 1. American College of Radiology. ACR-SIR-
SPR Practice Parameter on Informed
5.2.5 Discoverability of Communications
Consent for Image-Guided Procedures.
In malpractice lawsuits, most communication American College of Radiology Website.
related to any part of the case—whether written https://www.acr.org/Clinical-
or oral—is considered discoverable and can be Resources/Contrast-Manual. Accessed June
used as evidence at trial. However, certain 13, 2018.
important exceptions apply. The attorney–client
2. American College of Radiology. ACR
privilege is one of the oldest recognized
Practice Parameter for Communication of
privileges for confidential communications. It
Diagnostic Imaging Findings.
encourages clients in all legal matters (not just
https://www.acr.org/-/
malpractice cases) to make full and frank
media/ACR/Files/Practice-Parameters/
disclosures to their attorneys, who should then
communicationdiag.pdf. Accessed June
be better able to provide candid advice and
13,2018.
effective representation. Nearly all
communication between a client and his or her 3. Cooper JA. Responsible conduct of radiology
attorney is protected from discovery. For this research: part II. Regulatory requirements
reason, physicians involved in lawsuits are for human research. Radiology 2005;236:748-
strongly discouraged from speaking with any 752.
parties other than their attorneys about any 4. Lam DL, Medverd JR. How radiologists get
elements of their cases. paid: resource-based relative value scale
Most jurisdictions also protect certain peer and the revenue cycle. AJR Am J Roentgenol
review activities from legal discovery. Peer 2013;201:947-958.
review protection laws are designed to provide 5. Schoppmann MJ, Sanders DL. HIPAA
an incentive for healthcare providers to compliance: the law, reality, and
perform ongoing quality improvement recommendations. J Am Coll Radiol
activities without fear of increased tort risk. As 2004;1:728-733.
a general rule, no person who participates in
any approved peer review process shall be 6. Shields W, Hoffman T. Protecting your
permitted or required to testify in any civil peer-review rights. ACR Bulletin
action as to the findings, recommendations, 2011;66(1):24.
evaluations, opinions, or other actions of the 7. Thorwarth WT, Jr. From concept to CPT code
peer review process. However, to compensation: how the payment system
communications are only protected if they works. J Am Coll Radiol 2004;1:48-53.
occur within established peer review processes;
8. Whang JS, Baker SR, Patel R, Luk L, Castro
informal conversations with colleagues outside
A, 3rd. The causes of medical malpractice
established peer review processes, for example,
suits against radiologists in the United
are typically not protected from legal discovery.
States. Radiology 2013;266:548-554.

2025 Noninterpretive Skills Study Guide 62

Chapter 6: Core Concepts of Imaging Informatics

6.1 Standards primary HL7 standards are the ones most

frequently used to achieve systems
DICOM
interoperability.
The Digital Imaging and Communications in
The HL7 V2 messaging standard is generally
Medicine (DICOM) standard
considered to be the most widely implemented
(http://dicom.nema.org) is the international
healthcare-related standard in the world. This
standard that specifies protocols for display,
text- based standard facilitates the exchange of
transfer, storage, and processing of medical
medical data by enabling interoperability
images. The DICOM standard applies to
between many types of electronic medical
storage of both pixel-based image data and
systems that need to communicate. HL7 V3,
metadata. The metadata, located in the
while more human-readable, has been less
“DICOM header” of the image, contains
widely adopted in the industry because of its
information about the image, series, exam,
increased complexity. The newer HL7 Fast
patient, imaging facility, and scanner. The data
Healthcare Interoperability Resources (FHIR®)
are organized into separate fields, each of
standard allows software developers to use
which has a unique identifier so that it can be
internet transactions to exchange medical data
queried directly. DICOM transactions enable
between systems, increasing the potential for
data to be queried, retrieved, and transmitted
data exchange between systems.
between systems in an organized fashion. They
also allow for information about an order to be Ontologies
transmitted between the radiology information Ontologies are formal collections of terms and
system (RIS) and the modality (e.g., the CT, their inherited or causal relationships. RadLex
MR, or ultrasound machine) rather than having (http://www. radlex.org) is the largest
to be manually entered by the technologist and radiology-specific lexicon. It contains more than
risking incorrect data entry. 68,000 terms that describe imaging anatomy,
Standard DICOM data elements are required to procedures, and pathology. A special portion of
contain specific information while private data the RadLex ontology, the RadLex Playbook,
elements can be defined by the vendor. To defines standard imaging exam names,
enable interoperability between systems, descriptions, and codes. The RadLex Playbook
vendors who implement products that use has been merged with LOINC (Logical
DICOM are expected to provide customers Observation Identifiers Names and Codes), the
with conformance statements that detail their international standard nomenclature for health
use of the DICOM standard. measurements, observations, and documents.

HL7
HL7 (http://www.hl7.org) is the international 6.2 The Reading Room Environment
standards organization responsible for
PACS
developing and maintaining standards for the
exchange, integration, sharing, and retrieval of The PACS (picture archiving and
medical information (i.e., nonimage data). The communications system) is the radiologist’s

2025 Noninterpretive Skills Study Guide 63

primary tool for imaging viewing and recommends that ideal reading room ambient
interpretation. Basic components of PACS lighting fall in the range of 25 to 50 lux. This
include a workstation, display, short-term level of lighting is similar to standing under a
storage, and long-term archive. PACS street light at night in dark surroundings. The
communicates with imaging modalities using maximum gray value luminance for diagnostic
DICOM transactions, and with the RIS and/or monitors is recommended to be at least 350
EMR using HL7 transactions that are translated cd/m2 for nonmammographic interpretation
to and from DICOM. Unlike original PACS and 420 cd/m2 for mammographic
implementations that required a physical interpretation. By way of reference, top-
workstation to run, the modern PACS can be performing flat screen televisions on the market
entirely web-based and accessible on mobile in 2017 have a peak luminance upwards of 400
devices as well as on desktop thin clients. cd/m2.
VNA Compression
The development of the vendor-neutral archive Compression is used to decrease image file size
(VNA) allows data to be stored in a central to speed up transfer and decrease storage
archive that may support viewers for multiple requirements. Lossless compression is achieved
types of DICOM images (e.g., radiology, by decreasing redundant image information
cardiology, operating room, etc.), as well as for (e.g., the black background of a CT image).
non-DICOM data, including photographs and Because image content is preserved, lossless
pathology slides. Enterprise imaging relies compression can only reduce image file size by
heavily on VNA technology to facilitate approximately 3:1. Lossy compression allows
dissemination, viewing, and storage of medical for more substantial image size compression
imaging data beyond radiology. Determining (on the order of 10:1) by irreversibly discarding
how best to format and exchange the metadata unnecessary or minimally important image
(e.g., patient information, body part, date of information without significantly
acquisition, etc.) accompanying a non-DICOM compromising diagnostic quality.
image is a major challenge in enterprise
Ergonomics
imaging.
Like all individuals who spend many hours
RIS
working on a computer, radiologists are
The radiology information system (RIS) is a susceptible to repetitive strain injuries (RSI).
software application that manages all aspects of For example, carpal tunnel syndrome
an imaging exam, including order (involving the median nerve) often occurs due
reconciliation, patient scheduling and tracking, to dorsiflexion of the wrist from upward
communication with modalities and PACS, angulation of the wrist while typing. Cubital
reporting, results notification, and billing. The tunnel syndrome (involving the ulnar nerve)
RIS may be a standalone application or a can occur due to RSI at either the wrist or the
component of the electronic medical record elbow. DeQuervain tenosynovitis occurs
(EMR) application. Both PACS and RIS can be secondary to RSI of the thumb.
used to drive clinical workflow.
Workstation configurations that promote a
Image Displays neutral body position with the forearm, wrist,
and hand parallel to the floor, lumbar support,
The ACR-AAPM-SIIM technical standard

2025 Noninterpretive Skills Study Guide 64

and appropriate distance between the user and Radiology systems are considered to be high-
the display can help to decrease the incidence availability (HA) systems. HA systems must have
of RSI among radiologists. the ability to perform automated recovery and
failover operations in the event of service
disruption. The uptime expectations of an HA
6.3 From Order to Report: Workflow system can be expressed as a “number of nines.” For
Considerations example, PACS is generally expected to perform at
Workflow Steps “four nines”, or 99.99% uptime, which translates to
no more than approximately 50 minutes of
Medical imaging depends on interoperability downtime a year. Fault tolerance (FT) refers to the
between many systems, including PACS, RIS, ability of a system to continue to function if one of
EMR and imaging modalities, as data are its components fails. To avoid single points of
transferred via DICOM and HL7 transactions. failure, redundancy is built into essential
The process begins with an order placed in the components of a system (e.g., servers, network
EMR. HL7 transactions communicate the order connections, data archives, etc.) to achieve a high FT.
to the RIS (if it is a separate system). The RIS
communicates order information to the relevant
imaging modality (meaning the machine) via 6.4 Data Privacy and Security
the DICOM Modality Work List, and the
De-identification of Images
modality communicates with the PACS via
DICOM transactions. The radiologist views the De-identification involves removing protected
images on PACS and dictates the report using health information (PHI), as defined by HIPAA,
voice recognition. The reporting software then from an imaging examination such that the
sends the report to the RIS and EMR via HL7 identity of the patient cannot be directly
transactions. determined based on information contained in
the images or the metadata. However, de-
Downtime Procedures
identified images may contain information that
Downtime procedures include disaster enables an approved entity to identify the
recovery (DR) and business continuity (BC) patient using a key. In contrast, anonymization
procedures. DR policies direct activities that involves removing all PHI and other
should be followed in the event of a disaster, identifiable data from an imaging examination
such as a large-scale, unexpected, highly such that the identity of the patient is not
disruptive event, whether natural or human in revealed and cannot can be re-established in the
origin. future. PHI contained in the metadata can
DR policies typically include a description of typically be removed via automated de-
off-site data backup systems, including the identification processes. In some cases,
frequency of backup cycles, and the steps “burned-in” PHI (such as in ultrasound images)
required to restore critical data in the event of a also must be removed to fully de-identify
disruption. BC policies refer to the necessary medical images. Because the contours of a
systematic precautions, backups, and failover patient’s face can be reconstructed from CT or
routines required to continue to care for MRI of the head, imaging that includes the face
patients when a system failure (such as a power is also considered PHI.
outage) occurs under otherwise routine
working conditions.

2025 Noninterpretive Skills Study Guide 65

De-identification of Report Text region of interest from an image or extracting a
subset of images from an image stack for further
De-identification of report data is less
analysis. For example, segmentation of gray matter
straightforward than de-identification of image
and white matter from MRI of the brain may be the
data, because PHI does not occur in radiology
first step to a more advanced analysis of atrophy in
reports in the same form or with the same
neurodegenerative disorders.
consistency. De- identification of report data
often requires manual review or application of Image registration involves aligning one image set
specialized algorithms. onto the coordinate space of another image set to
allow a more direct comparison of the two image
Tools for de-identification of other medical text,
sets. Deformations can be rigid (e.g., rotation,
such as encounter notes or progress notes,
translation, reflection), affine (e.g., shearing,
generally do not work as well for radiology
scaling), or elastic. Elastic deformation involves
reports, because of the less frequent appearance
local warping of an image to better align the target
of PHI in radiology reports compared to medical
image with the reference image. Elastic
text.
deformation is one type of image registration that
Cybersecurity can accommodate changes such as patient position,
Ransomware attacks occur when bad actors lung expansion, or soft tissue shape changes in
encrypt files and systems and demand a ransom aligning image sets.
in exchange for the decryption key. Such attacks 3-D post-processing is a required component of CT
can be catastrophic to a radiology practice and and MR angiography and can supplement other
its associated hospital or health system. Typical advanced imaging, such as cardiac MRI and brain
downtime procedures may not be sufficient for MRI for tumor analysis. Simple 3-D post-
recovery. Instead, a long-term analog (e.g., processing, such as MPRs, MIPs, and volume
paper-based) workflow may be necessary to rendering, can be performed on most modern
maintain business continuity while versions of PACS. More elaborate analysis such as
compromised files and systems are isolated and curved planar reformats (CPRs), functional
data recovery is attempted. Eventually, any analysis, and cinematic rendering, however, may
recovered data will have to be reconciled with require additional thin-client software and may be
new data collected after the attack. supported by a dedicated team of experts, such as a
3-D lab.

6.5 Image Post-Processing 6.6 Artificial Intelligence

Post-processing refers to image transformations Artificial intelligence (AI) is the field of
performed after acquisition. These computer science that gives computers the
transformations may occur before image ability to mimic human intelligence. Machine
display, interpretation, or quantitative analysis. learning (ML) is a subfield of AI that enables
Post-processing includes techniques such as computers to learn a task without an explicit
image segmentation, registration, and three- set of instructions. Deep learning (DL) uses multi-
dimensional (3-D) post-processing using layered neural networks with weighted connections
maximum intensity projections (MIPs), to analyze data, and works with
multiplanar reformats (MPRs), or volume both images and text. AI serves as an adjunct to the
rendering. human radiologist; at present, few autonomous AI
Segmentation involves isolating or extracting a applications exist for radiology.

2025 Noninterpretive Skills Study Guide 66

Supervised and Unsupervised Learning networks and recurrent neural networks are DL
algorithms often used in radiology applications.
Supervised learning exposes an algorithm
Image data are pre-processed before use for training
to a labeled set of training data and then
or inference to make them suitable for input to an
evaluates how well the resulting model
AI algorithm; this may include rescaling, cropping,
predicts labels on a different set of test
denoising, histogram equalization, and often
data. It is important that the test set data
downsampling (sometimes by as much as 10x). This
not overlap the training data, so that
decrease in image resolution may reduce
model performance is not artificially
the conspicuity of subtle findings in images
exaggerated.
unless sufficient training examples are provided.
Unsupervised learning exposes an
Natural Language Processing
algorithm to a set of data without pre-
defined labels or categories and expects Natural language processing (NLP) is the analysis
the algorithm to organize the data. of human language data. Common uses in
Unsupervised learning models must be radiology reports include detection of critical
validated and may not perform as well as findings or follow-up recommendations,
supervised models without further longitudinal lesion monitoring, assessment of
training. report compliance with practice requirements, or
radiology-pathology correlation. Text documents
Training AI Models
are also pre-processed like images, with removal of
Generating training data for radiology stop words and punctuation, conversion to lower
requires experts to label images or text, case, and tokenization. Text data can be tokenized
which is time- and resource- intensive. A by converting words and phrases to numeric
common pitfall in model training is representations for input into deep learning
overfitting the model to the data, such that models through a process known as embedding.
it performs very well on similar data (e.g.,
Deployment Challenges
at the organization where it was trained),
but does not perform as well on data that Major challenges in deploying AI for radiology
are different in some way (e.g., data from include understanding how the “black box” model
another organization). Labeling images is produces its results, ensuring that the model
task specific and can be as simple as performs reliably in all potential applied settings
assigning a label to an entire image or and conditions, and efficiently integrating the
study (e.g., “normal”, “abnormal”), or it model into the clinical workflow. Once deployed,
may require an expert to use segmentation models should be monitored to identify data drift,
tools to identify an anatomic structure or in which model performance degrades over time
disease process. As with de-identification, due to gradual changes in the data it processes.
labeling text data or workflow data Additionally, the way that radiologists interact
requires different tools than labeling image with AI should be monitored to guard against
data. automation bias, in which the computer is always
assumed to be more correct than the human
Deep Learning for Images
practitioner.
Deep learning models use neural networks
Bias in AI
with an input layer, multiple hidden layers,
and an output layer to perform inference or Bias in AI can occur due to the training data, the
make predictions. Convolutional neural model architecture, or the conclusions drawn by

2025 Noninterpretive Skills Study Guide 67

end users based on model outputs. Statistical 6. Steinkamp J, Cook TS. Basic Artificial
bias results when a model does not represent Intelligence Techniques: Natural
the true features of the population. One Language Processing of Radiology
example of statistical bias is sampling bias, in Reports. Rad Clin N Am 2021; 59: 919-31.
which the data used to train the model do not
represent the patients to whom the model will 7. Obermeyer Z, Powers B, Vogeli
ultimately be applied. Social bias has the C,Mullainathan S. Dissecting racial bias
potential to exacerbate health disparities by in an algorithm used to manage the
adversely affecting underrepresented health of populations. Science 2019;
populations. For example, a model may predict 366(6464): 447-53.
better health outcomes in a patient population
that does not use healthcare resources as
frequently, but it may overlook the fact that the
use or lack thereof is related to access to care
rather than their state of health.

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