Patient Safety Handbook: Second Edition
Patient Safety Handbook: Second Edition
Patient Safety Handbook: Second Edition
Handbook
Second Edition
Edited by
Barbara J. Youngberg, JD, MSW, BSN, FASHRM
Visiting Professor of Law
Academic Director, On-Line Legal Education
Loyola University Chicago
School of Law
Beazley Institute for Health Law and Policy
Chicago, IL
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Library of Congress Cataloging-in-Publication Data
Patient safety handbook / edited by Barbara Youngberg. -- 2nd ed.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-0-7637-7404-2 (pbk.)
I. Youngberg, Barbara J.
[DNLM: 1. Patient Safety. 2. Medical Errors--prevention & control. WX 185]
610--dc23
2012018525
6048
Printed in the United States of America
16 15 14 13 12 10 9 8 7 6 5 4 3 2 1
Preface xxi
Foreword xxv
Helen Haskell
Contributors xxvii
Chapter 1 Understanding the First Institute of Medicine Report and Its Impact
on Patient Safety 1
Marsha Regenstein, PhD, MCP
Errors, Adverse Events, and Negligence: Some Common Terminology 2
Medical Errors and Patient Safety: What Does the Literature Show? 2
The Harvard Medical Practice Study 3
The Utah and Colorado Study 4
Other Selected Studies 4
To Err Is Human: The IOM Report and Recommendations 5
The Clinton Administration’s Response to the IOM Report 6
Legislative Proposals on Patient Safety 7
Current Reporting Requirements 7
State Requirements 7
Requirements of The Joint Commission 8
The Response from the American Hospital Association 9
Other Responses 9
Reasons for Optimism: Successful Strategies 10
Conclusion 12
Appendix: IOM Recommendations 12
References 15
Chapter 2 Patient Safety Movement: The Progress and the Work That Remains 17
Manisha Shaw, MBA, RCP and Karla M. Miller, PharmD, BCPP 17
Introduction 17
A History of Patient Safety 18
Creating a Culture of Safety 20
Most Common Patient Safety Concerns 21
Medication Errors 21
Hospital-Acquired Infections 22
Surgical-Site Errors 22
Device Malfunctions 23
Error in Diagnosis 23
The Impact of Literacy on Patient Safety 23
Making Care Safer Through Research 24
Emerging Trends 24
Technology 24
Conclusions: Where We Stand Today 25
References 25
Chapter 3 Accelerating Patient Safety Improvement 29
Thomas R. Krause, PhD and John Hidley, MD 29
Introduction 29
Slow Progress 29
Getting in Gear 30
A Universal Metric for Patient Safety 31
Healthcare Worker Safety 34
A Healthcare Culture of Safety 35
Conclusion 36
References 36
Chapter 4 The Importance of Leadership to Advance Patient Safety 39
Barbara Balik, RN, EdD
Definition: Leaders 40
Definition: Healthcare Organization 40
How to Use the Content 40
Another Way 40
Board of Directors Leadership of Quality and Safety 41
Governance Role and Accountability for Safety 41
Assessment of Specific Behaviors to Govern for Safety 42
Questions Designed for Board Members to Understand the Safety
Strategy and Policy Implementation Within the Organization 42
Safety Science and Just Culture
Skills 43
Leadership Behaviors for Safety 44
Model for Leading and Sustaining Transformational Change 45
Personal Characteristics 45
A Single-Brain Organization 48
Knowledge to Lead Complex Organizations Plus Skills in the Science of
Safety, Just Culture, and Team Development 48
Assessment Tool—Individual Leaders or Teams 54
References 54
Additional Resources 55
Chapter 5 An Organization Development Framework For Transformational Change in
Patient Safety: A Guide For Hospital Senior Leaders 57
Raj Behal, MD, MBA
Scenario 58
What Is Culture? 58
Revisiting the Scenario 59
Conclusions 153
References 154
Chapter 12 Admitting Imperfection: Revelations From the Cockpit for the
World of Medicine 157
John J. Nance, JD
The Myth of Medical Infallibility 159
Aviation as a Cautionary Example for Health Care 161
Similarities between Aviation and Health Care 162
The Safety Hazards of the Isolated Omnipotent Leader:
Firing Captain Kirk 163
How Aviation Addressed Teamwork Problems 166
The Picard Method 167
Conclusion 168
Chapter 13 Creating a Just Culture: A Nonpunitive Approach to Medical Errors 169
Laura Ashpole, JD
Introduction 169
What Is a Just Culture? 170
Evaluating and Responding to Medical Errors 171
Building the Foundation for the Introduction of Just Culture Principles 171
One Organization’s Approach to Establishment of a Just Culture 172
The Dana-Farber Cancer Institute’s “Principles of a Fair and Just Culture” 173
A Statewide Effort to Implement the Just Culture Model 175
The Tools Necessary for Effectuation of a Just Culture 176
Conclusion 178
References 178
Chapter 14 Addressing Clinician Performance Problems as a Systems Issue 179
John A. Fromson, MD
References 184
Chapter 15 Improving Health Literacy to Advance Patient Safety 185
Caroline Chapman, JD 185
Introduction 185
Health Literacy Definition 186
Health Literacy and Patient Safety 187
Health Literacy Data 188
Safe Care for Non-English Speakers 190
Interpreters 191
Translation 191
Cultural Competency 192
The Law and Health Literacy 193
Informed Consent 193
Advanced Directives 194
Accreditation 194
Health Literacy Principles and Programs 194
Health Literacy Programs 195
Conclusion 224
References 224
Chapter 18 Reducing Medical Errors: The Role of the Physician 225
Roy Magnusson, MD, MS, FACEP
The Changing Landscape 225
Central Role of the Physician 226
Selecting the Medical Staff 226
The Value of Peer Review and Ongoing Assessment of Clinical Performance 227
Collecting and Using Outcomes Data 227
Identifying and Assisting the Impaired Physician 227
Dealing with Disaster 228
Systems Redesign 229
Matching Resources to Needs: Physicians as Senior Administrators 230
Establishing Standards and Policy 230
Evidence-Based Medicine 231
Conclusion 231
References 232
Chapter 19 Engaging General Counsel in the Pursuit of Safety 233
Barbara J. Youngberg, JD, MSW, BSN, FASHRM
Protection of Medical Error Data 235
Peer Review Protection 236
The Value of Error Data to Plaintiff Attorneys 238
A Defense Attorney’s Strategy 239
References 241
Chapter 20 Growing Nursing Leadership in the Field of Patient Safety 243
Mary L. Salisbury, RN, MSN and Robert Simon, EdD, CPE
The Worst of Times 243
The Best of Times 244
Background: History and Duty of Nursing in Comprehensive Patient Safety 244
Characteristics of a Comprehensive Patient Safety Solution 245
The Form of Patient Safety is Embodied in Vision 246
The Function of Comprehensive Patient Safety is Embodied in Teamwork 247
Teamwork Case Study: MedTeams 248
History 248
Needs Assessment: Teamwork in Emergency Health Care 249
The MedTeams Teamwork Training System 249
Improving the Delivery of Emergency Care: MedTeams Validation 251
Leadership Considerations 251
Teamwork Summary 253
Conclusion 254
References 254
Chapter 21 Teamwork Communications and Training 257
Richard Lauve, MD
Definitions and Initial Thoughts 257
Reducing the Barriers to Collaboration 257
Conclusion 502
References 503
Chapter 35 Moving from Traditional Informed Consent to Shared Patient–Provider
Decision Making 505
Shannon Flaherty
Introduction 505
The Medical and Legal Origins of Informed Consent 506
The Paternalistic Model for Patient–Provider Relationships 506
Informed Consent as a Response to Medical Paternalism 507
Recognition of the Legal Doctrine of Informed Consent in Medical
Practice 509
Developments in Medical Research and Practice: Shifting Toward
Patient Involvement 509
New Patient Decision-Making Models to Achieve Informed Consent 509
The Informed Decision-Making Model 510
The Professional-as-Agent Model 510
The Shared Decision-Making Model 510
Challenges and Benefits of Implementing a Shared Decision-Making Model 512
Challenges Implementing the Shared Decision-Making Model 512
Challenges Related to Communication: The Patient–Provider
Relationship 512
Provider Concerns Regarding Additional Time with Patients 513
Resources Needed to Implement Communication Tools 513
Benefits of Implementing a Shared Decision-Making Model 513
Suggestions for Improved Implementation of Shared Decision Making 515
Improving Provider Education 515
Improving Patient Education 515
Personalizing Patient Consent Forms 515
The Future of Informed Consent and Shared Decision Making 516
References 517
Chapter 36 Trust, Disclosure, Apology: How We Act When Things Go Wrong Has an
Impact on Patient Safety 521
Keith Siddel, MBA, JD, PHD
Trust 522
Disclosure 522
Apology 524
Outcomes 525
Conclusion 527
References 527
Chapter 37 Why, What, and How Ought Harmed Parties Be Told? The Art, Mechanics,
and Ambiguities of Error Disclosure 531
John D. Banja, PhD
Why Error Disclosure Is a Moral Imperative 532
How to Communicate Harm-Causing Error 533
Consideration 1: The Initial Contact 534
Chapter 39 The Role of Ethics and Ethics Services in Patient Safety 551
Erin A. Egan, MD, JD
Principles of Clinical Medical Ethics: Beneficence, Paternalism,
Nonmalificence, Justice, and Fiduciary Duties 552
Ethics Committees and Consultation Services 554
Patient Safety as an Ethical Issue 555
Specific Applications of Ethics in Particular Situations 557
Medical Mistakes 557
Provider Impairment and Incompetence 557
Informed Consent 558
Conclusion 558
Notes 558
Chapter 40 Telemedicine—Risk Management and Patient Safety 561
John Blum, JD, MHS and Doni McCoy, JD, LLM
Definitions 561
Major Variables for Risk Management/Patient Safety 562
Medical Liability 562
Practice Standards and Guidelines 566
Privacy/Security Considerations 566
Key Federal and State Regulatory Concerns 569
Conclusion 575
References 576
Chapter 41 The Criminalization of Medical Malpractice from Past to Present and the
Implications on Patient Safety and Voluntary Error Reporting 579
Laverne Largie, JD, LLM
Introduction 579
History of Criminalizing Medical Malpractice 579
The AMA’s Position on Criminal Prosecution May Limit Appropriate
Accountability 582
How Severe Cases of Medical Malpractice are Handled Today: An Analysis
Surrounding the Medical Care Resulting in the Death of Michael Jackson
and Anna Nicole Smith 583
The Difference Between Civil and Criminal Prosecution 584
Index 605
Tackling the second edition of Patient Safety Yet the ability or the willingness to translate
Handbook initially seemed like a relatively this knowledge into strategies that yield posi-
simple proposal. The first edition, which was tive change seems to lag far behind.
released in 2004, was actually conceptualized I have read the many articles and commen-
shortly after the landmark IOM report To Err Is taries on safety since the release of the IOM
Human made public what many clinicians, ad- report: some suggesting that great progress has
ministrators, and patients already knew: that been made and others (probably equal in num-
healthcare systems were poorly designed, ber) lamenting the fact that little progress has
preventable errors occurred frequently, and been made. In fact, both are probably true. We
people who entrusted their lives to providers know a great deal more about the complexities
and systems that promised a great outcome of the healthcare delivery system that predis-
were too frequently harmed or killed. pose individuals to err, we know that leadership
The science of safety was relatively nascent. is key in setting an agenda for change and in
Early leaders in the field such as Dr. Lucian aligning safety with the core vision and values
Leape and James Reason helped us all to begin of the organization, and we know that change
thinking differently about why the healthcare (even some of the seemingly simple things) is
system was so prone to error and how the sci- extremely hard to bring about and sustain in a
ence of safety (borrowed from other high haz- culture steeped in tradition and hierarchy.
ard industries) might be applied to health care Many providers continue to demand more
to better understand the root causes of error and better data and fail to appreciate that they
and to identify potential solutions for solving probably already have more than is necessary
specific safety problems. Early on, one of the to begin the process of change. We have all
recommendations offered by the drafters of learned that you can avoid the inevitable for a
the IOM report—to fund research to advance long time by simply asking for more proof. In
the science and study of safety—took root, my work with many hospitals, it is clear that it
and research into the most common types of is far easier to continue to study the problem
errors and to their etiology flourished. I would than to actually fix it and it is also easy to jus-
guess there are very few healthcare providers tify the limited effort to focus on safety by de-
who are not familiar with the common causes scribing the current conditions and challenges
of medication errors, the reasons wrong-sided faced by the healthcare industry, which often
procedures continue to happen, and the eco- seem to compete with the safety agenda.
nomic and emotional impact that preventable Clearly, many individuals and organizations
errors have on our healthcare delivery system. have provided great leadership to stimulate the
xxi
safety agenda, but far too often the impetus advocate. Of course, patients must be the rea-
for change is yet another tragic event, another son we rededicate ourselves to changing the
loved one lost, and another group of providers unsafe and overly complex systems that often
devastated by their role in, or proximity to, give rise to error, and we must listen to them
an event where significant harm to a patient so we know what things are of greatest con-
is the result. We must do better, and real and cern to them. But we cannot make patients
lasting change will occur only when healthcare and family members responsible for patient
providers and organizations acknowledge that safety. I find it unnerving when campaigns
they must hold themselves and their peers ac- are launched asking patients to “speak up” to
countable for safety, they must stop making ask their caregivers if they have washed their
excuses as to why safety is not a priority in hands or to challenge patients to know how
their organizations or within their practices, to escalate a concern when their loved one
and they must be willing to change practices seems in peril. It is once again an attempt to
and behaviors that we now know are counter- shift responsibility away from those individu-
productive to a culture of safety. als who are responsible and in the best posi-
As both a clinician and a lawyer, I have been tion to lead the change to someone who is
intrigued by how often I still hear the excuse vulnerable, frightened, and oftentimes too ill
offered that “we can’t be more transparent . . . or too timid to be an advocate. My fear is we
we can’t share information about our own er- might further harm patients and their loved
rors and best practices . . . we can’t hold our ones after an error by intimating that, if only
peers accountable” because the legal system they had been more assertive or more de-
is “so unfair,” “so punitive,” so “likely to de- manding of their care providers, they could
liver an unfair or unjust verdict.” This excuse have avoided or prevented the error. This
continues to inhibit progress in many areas. shifting of our responsibility onto others adds
It also has the impact of allowing providers insult to injury and often fails to allow provid-
to blame someone or something else for the ers to uncover the true root cause of the prob-
problems that really are under the control of lem. Patients should expect that when they
the caregiver and the caregiving organization. entrust their care to a provider or an organiza-
It seems somewhat obvious that most pa- tion that reasonable, safe, and effective care
tients enter the legal system only after harm will be provided and that preventable errors
has occurred or information has been with- will indeed be prevented, without their need-
held. So undoubtedly a better strategy would ing to maintain constant vigilance to protect
be to take control of the environment that is their loved ones. The fact that so many people
under our control and recognize that the only now state they would never leave their loved
way to not be put at risk by the legal system ones alone in a hospital is a testament to how
is to develop strategies for keeping patients little faith the public has in us, and this needs
free from harm. For over 30 years, doing the to change.
opposite has not proven to be the solution. In addition, providers should know that
Some looking at the table of contents of this their role in advocating for patient safety and
book might be concerned that there are no their efforts at creating and sustaining per-
specific chapters representing the patient’s sonal and collective accountability will not
responsibility or the patient’s role in patient only yield benefits for their patient but also
safety. This was actually intentional. My po- for them. Errors are devastating to those expe-
sition on patient safety is that once again it riencing them and to their loved ones, but the
is first and foremost the responsibility of the toll they take on the providers involved is also
provider and of healthcare organizations. It devastating. Working as a provider in our cur-
is a responsibility that we cannot pass off to rent healthcare delivery system is physically
a patient or a concerned family member or and emotionally exhausting, and providers
deserve to be in systems that support them change the way we educate physicians and
and that have processes in place to assure en- nurses so that they develop the competencies
sure both individual and collective success. needed to be safety champions. This recog-
If you read the first edition of Patient Safety nition of the need to create a measureable
Handbook, you will recognize that a number curriculum around safety is reinforced by the
of the chapters were retained because the tools available with this second edition, which
authors were actually ahead of the field and include specific learning objectives for each
the content of those chapters still provides a chapter, questions to test whether the most
necessary framework detailing the science of salient points were understood, and Microsoft
safety, the knowledge of error, and the role PowerPoint slides to review the highlights of
of various members of the healthcare team each chapter and to teach colleagues specific
in advancing a safety culture. More than half aspects of the topics presented.
of the chapters, however, are completely new It is my hope that the material provided
and reflect work that has been done over the in the second edition will enable you to see
past 10 years, along with specific strategies that while we are not yet where we need to
for making our systems, our providers, and be in making our systems safer, we are mak-
most importantly, our patients safer. Two new ing progress toward achieving safer and more
and important chapters address the need to transparent health care for all.
For those outside the medical profession— language used when speaking to us. But the
and to a large extent, those inside it as well— standards they were following came with cav-
the reasons for becoming involved in patient ernous wiggle room, enough to accommodate
safety are most often personal, and not in a even the most egregious errors and then noth-
good way. For my husband and I, this involve- ing was done to catch them after they had oc-
ment was precipitated by the loss of our bril- curred. Not just the process but the structure
liant, vibrant 15-year-old son, Lewis, who died was rife with potential for harm. In this con-
from a cascade of medical errors following text, James Reason’s Swiss cheese metaphor—
elective surgery. another piece of our new knowledge—seemed
I will not go into detail, but suffice it to say little more than a euphemism. The system, so
that a boy we regarded as one of the outstand- implicitly trusted by so many, was simply not
ing young men of his generation was casually set up to accomplish its goal. From our per-
sacrificed to medication error, hierarchy, and spective, there were more holes than cheese.
misplaced arrogance—in short, to all the short- We saw only one way forward from this
comings of the teaching hospital. Lewis en- experience—to bring some good out of the
tered the hospital a healthy, athletic teenager disaster that had befallen us. That was the be-
wearing shorts and sandals in the last days of ginning of a journey of advocacy that has yet
a late South Carolina autumn. Four days later, to end. In many ways, we were typical of fami-
we emerged without him into the first bright, lies affected by medical harm. Like most, we
cold days of winter. His path in those few days sought to bring hope out of despair, and we
can be traced in half a sentence: two hours in thought that the legacy of our son and thou-
surgery, two and a half days in recovery, and a sands of others would be the immediate re-
day and a half in calamitous decline before he form of the system that had taken their lives.
died, unrescued, in his hospital bed. Through Our aspirations seem almost quaint from our
all this, our concerns and pleas for help had current perspective. But we believed that a
gone unheeded. system so out of sync with its own mission
As we worked through Lewis’s medical re- could surely be brought back to its intended
cords to reconstruct the decisions that had path by a small group of determined people
been made, we were taken aback by what we bent on doing the right thing.
found. Most chilling was the gradually dawn- This all took place at the end of 2000, a
ing realization that despite their ultimately le- year after the Institute of Medicine’s report
thal mistakes, most of our son’s caregivers had To Err Is Human. Hope was high in that mo-
acted strictly by the book, even down to the ment. The problem had been delineated, and
xxv
we had both the will and the outline of a plan this. The industry of health care has been al-
to change it. Rereading parts of the 2004 edi- lowed to function with too little accountability
tion of Patient Safety Handbook, one can still to its patients, its practitioners, and its com-
feel that hope. And yet, there and elsewhere, munities and in the process has often lost the
many people were already expressing dismay virtues of openness, honesty, and altruism
at the slow pace of reform. The fifth anniver- that the public thinks should be its hallmark.
sary and then the 10th passed with much Patients will also tell you that fragmentation
soul-searching. Few thought we had shown and high-volume medicine—lack of time with
significant change to be proud of. their providers—are among the most signif-
No one can say we have not made many icant drivers of patient harm. The patient
advances. We have put to rest—in most cir- voice is essential to solving these problems.
cles, at least—the idea that patient harm is Left unaddressed, these difficult, overarch-
not a problem. We have meaningful support ing questions have the potential to negate all
from government entities. We have dedicated that is achieved through other patient safety
champions both within and outside of the sys- programs.
tem. Thanks in large part to the path blazed The bottom line is that much remains to
by consumer advocates in many American be done. Patients and families continue to en-
states, we have the beginnings of a system of trust themselves to systems that are fraught
transparency that has the potential of giving with risks over which they often have no
patients a clearer idea of benefits and risks. power. Technical solutions, standardization,
And yet we still do not have a real-time pic- teamwork, improved communication, culture
ture of the extent of patient harm, and we change—these all are necessary, important,
do not know to what extent our efforts in the and transformative. But they are only parts of
past few years may or may not have helped a larger solution. Above all, we need to take
reduce it. on patient safety as an ethical challenge, one
Patients overwhelmingly see patient harm that pays careful attention to patient concerns
as an ethical issue, and those who think about and aspires to broad and innovative change
it see transparency as the essential underlying at a fundamental level. I urge you to read this
principle of reform. They are not mistaken in volume with that in mind.
xxvii
Emily Rhinehart, RN, MPH, CIC, CPHQ Robert Simon, EdD, CPE
Vice President Education Director
Chartis Insurance Center for Medical Simulation
Atlanta, GA Boston, MA
Gwen Sherwood, PhD, RN, FAAN Barbara J. Youngberg, JD, MSW, BSN,
Professor and Associate Dean for Academic FASHRM
Affairs Visiting Professor
University of North Carolina at Chapel Hill Academic Director On-Line Legal Education
School of Nursing Loyola University Chicago
Chapel Hill, NC School of Law
Beazley Institute for Health Law and Policy
Keith Siddel, MBA, JD, PhD Chicago, IL
Chief Marketing Officer
Health Revenue Assurance Associates Kuo (Frank) Yu, PhD
Plantation, FL Assistant Professor
City University of Hong Kong
Kowloon Tong
Kowloon, Hong Kong