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Introduction ix
Chapter 4. Determining What Happened and Why: The Search for Proximate Causes 71
Step 4: Determine What Happened 71
Step 5: Identify Contributing Process Factors 72
Step 6: Identify Other Contributing Factors 73
Step 7: Measure—Collect and Assess Data on Proximate and Underlying Causes 76
Step 8: Design and Implement Immediate Changes 79
iii
iv
Chapter 8. Root Cause Analysis Case Studies from the Field 177
Root Cause Analysis of Heparin-Induced Thrombocytopenia (HIT) Leads to
Earlier Identification and Intervention 177
Root Cause Analysis of Surgical Site Infections Spurs Reforms That Improve
Patient Safety and Save Money 179
Removal of Wrong Kidney Triggers Root Cause Analysis Leading to Process Improvement 182
Root Cause Analysis Training Helps Reduce Falls in Rural Health Care Facilities 185
Learning to Improve Safety: False-Positive Pathology Report Results in Wrongful Surgery 193
Using Aggregate Root Cause Analysis to Reduce Falls and Related Injuries 202
Glossary 213
Index 223
vi
vii
Since then, reporting of sentinel events has steadily here: Do root cause analyses of near-miss events produce
increased, root cause analysis has been accepted as the the same patterns of causation as root cause analyses of
appropriate response, and the quality of those analyses events that resulted in harm? Are the patterns of event
has improved dramatically, helped in no small measure causation found in voluntary reporting programs (such
by Root Cause Analysis in Health Care: Tools and Tech- as the Joint Commission’s) representative of the patterns
niques, now in its fourth edition. This is must reading of causation for similar events occurring in the general
for all quality improvement professionals, patient safety population of health care organizations? Do root cause
officers, and risk managers and a valuable resource for all analyses undergoing criteria-based independent review
who aspire to clinical or administrative leadership roles and refinement produce patterns of causation compa-
in any health care organization. rable to those of unsupervised root cause analyses? Will
standardization of processes improve safety in health
In addition to refining the techniques of event analysis, care as it has in other high-risk fields?
improvement planning, and effectiveness measurement
as they have evolved since the first edition of this work As you read this book, I believe you will be persuaded
in 2000, the Fourth Edition broadens the applicabil- both that we have made great progress and that there
ity and usefulness of root cause analysis while directly is much left to do. Root Cause Analysis in Health Care:
addressing the current key questions of the patient safety Tools and Techniques, Fourth Edition is your field guide
movement: With all we have studied and all we have for this next great adventure in patient safety.
learned, why are we still seeing sentinel events in alarm-
ing numbers? Is root cause analysis worth the time and —Richard J. Croteau, M.D.
effort it takes to do it well? Are we asking the right ques- Patient Safety Advisor,
tions? Are we doing the right things? Are we doing them Joint Commission International
correctly? There are important research implications
viii
Indeed, the very presence of medical errors indicates Although these reports and chart reviews illuminate the
a continuing paradox in modern medicine. Despite problem, it is virtually impossible to know how many
ix
patients suffer as a result of medical failures; however, advances and great gains in knowledge, health care
any single failure, error, or sentinel event is a cause for systems are, and will continue to be, appropriately
concern. Sentinel events can result in tragedy for indi- dependent on human intervention. The rigorous finan-
viduals served and their families, add costs to an already cial constraints imposed by managed care and the need
overburdened health care system, adversely affect the to reduce health care expenditures have affected every
public’s perception of an organization, and lead to litiga- type of health care organization. No organization is
tion. They can also deeply affect health care profession- immune. Organization leaders are reassessing their
als who are dedicated to helping individuals receiving workforces. Work loads are heavier, creating increased
care, treatment, or services. stress and fatigue for health care professionals. Caregivers
are working in new settings and performing new
Health care organizations, then, have no choice but to functions, sometimes with minimal training. Skill mixes
answer one key question: Why do these errors or failures are shifting. As life expectancies increase and diseases
continue to occur? become ever more challenging, health care providers are
not only caring for older patients than in the past, but
To get an answer, health care organization leaders need they are faced with more severe diseases and conditions.
to consider root cause analysis—a process for identify- In short, the health care environment is ripe for serious
ing the basic or causal factor(s) underlying variation in problems caused by systems failures.
performance, including the occurrence or possible oc-
currence of a sentinel event—and all of its related tools Health care organizations are constantly evolving
as a means toward safer health care services. That is, root because of changes in reimbursement, new technol-
cause analysis can be used to uncover the underlying ogy, regulatory requirements, and staffing levels. These
factors that lead to errors and failures and subsequently modifications cause policies and procedures to change
move organizations to deliver care without such mis- often and, in most cases, quickly. As a result, it is dif-
takes, which in turn will improve the overall quality of ficult to maintain consistency in processes and systems,
care that patients receive. which leads to variation. Often, this variation results in
increased failure risk.
Although health care organizations in the United States
often use root cause analysis to help improve quality en Instances of errors and sentinel events within health
route to accreditation, such analysis has many broader care organizations have been reported in the media with
applications around the world. After all, high-quality increasing regularity. These events cast a shadow on
care is high-quality care, whether it is delivered in the public’s trust of health care. People justifiably ask,
New York City or Dubai or Singapore. Organizations “What’s going on?” Failure detection, reduction, and
worldwide need to consider how root cause analysis can prevention strategies are receiving needed new impetus
be used to help take quality improvement in the right as the health care industry recognizes the need for a pro-
direction. active approach to reduce the risk of failure. Regulatory
and accrediting agencies have responded to the public’s
The Current Health Care Environment concerns and the data outlining the medical errors by
Health care continues to experience dramatic change. developing and revising standards and survey processes
As health care organizations become more complex, to emphasize that the primary focus is patient safety.
their systems and processes are increasingly interdepen-
dent and are often interlocked and coupled. This The use of root cause analysis is also expanding. Instead
interconnectedness increases the opportunity for failure of merely being seen as a tool to investigate sentinel
and makes the recovery from failure by those involved events, root cause analysis is now being used to delve
more difficult. The rapid explosion of the medical into the causation associated with a series of less-
knowledge base has made it increasingly challenging for serious errors and near misses. In essence, health care
practitioners to stay up-to-date. Despite technological organizations no longer have to wait until a serious,
life-threatening event occurs to enact a root cause Root Cause Analysis in Health Care: Tools and Techniques,
analysis program. Instead, organizations can begin to Fourth Edition provides health care organizations with
improve quality by addressing less-tragic—but still up-to-date information on the Joint Commission’s
important—events as well as the near misses that by Sentinel Event Policy and safety-related requirements. It
good fortune have not done harm but signal the risk of also describes the similar Sentinel Event Policy of Joint
harm in the future. Commission International. The book includes examples
that guide the reader through application of root cause
When an adverse outcome, a sentinel event, or a cluster analysis to the investigation of specific types of sentinel
of less-serious incidents or near misses occurs, organiza- events, such as medication errors, suicide, treatment
tions must develop an understanding of the contribut- delay, and elopement. For ease of access and use by root
ing factors—the fundamental reasons a problem has cause analysis teams, practical checklists and worksheets
occurred—and the interrelationship of those factors. are offered at the end of each chapter.
Next, the organization must implement improvement
or redesign efforts to be more resilient. Resilience is the This publication provides and explains the Joint Com-
degree to which a system continuously prevents, detects, mission’s framework for conducting a root cause analy-
mitigates, or ameliorates hazards or incidents. It is clear sis. It also helps organizations do the following:
that general knowledge about adverse events is limited at • Identify the processes that could benefit from root
best. General knowledge is even more limited in the area cause analysis
of proactive design or redesign of health care processes • Conduct a thorough and credible root cause analysis
and systems. These design aspects aim to prevent or at • Interpret analysis results
least minimize the likelihood of future failures and to • Develop and implement an action plan for improve-
protect individuals from the harmful effects of failures ment
when they do occur. • Assess the effectiveness of risk reduction efforts
• Integrate root cause analysis with other programs
Purpose of the Book
Root Cause Analysis in Health Care: Tools and Techniques, It is our hope that even without the occurrence of an
Fourth Edition is intended to help health care organiza- adverse event, health care organizations will embrace
tions prevent systems failures by using root cause analy- the use of root cause analysis to investigate near misses
sis to do the following: in order to minimize the possibility of future failures
• Identify causes and contributing factors of a sentinel and thereby to improve the care, treatment, and services
event or a cluster of incidents provided at their facilities.
• Implement risk reduction strategies that decrease the
likelihood of a recurrence of the event or incidents Overview of Contents
• Determine effective and efficient ways of measuring Root Cause Analysis in Health Care: Tools and Tech-
and improving performance niques, Fourth Edition provides health care organizations
with practical, how-to information on conducting a
Root cause analysis is an effective technique most root cause analysis. Twenty-one steps are described (in
commonly used after an error has occurred to identify Chapters 3 through 6). Teams conducting a root cause
underlying causes. Failure mode and effects analysis analysis might not follow these steps in a sequential
(FMEA) is a proactive technique used to prevent process order. Often, numerous steps will occur simultaneously,
and product problems before they occur. Health care or the team will return to earlier steps before proceeding
organizations should learn both techniques to reduce to the next step. It is critical for teams to customize or
the likelihood of adverse events. This book on root cause adapt the process to meet the unique needs of the team
analysis and its companion volume on FMEA5 outline and organization. Appropriate tools for use in each stage
both of these approaches of examining systems failures of root cause analysis are identified in each chapter. A
in a step-by-step manner. chapter-by-chapter description of the contents follows.
xi
Chapter 1, “Root Cause Analysis: An Overview,” takes Chapter 4, “Determining What Happened and Why:
a holistic look at root cause analysis. It describes varia- The Search for Proximate Causes,” provides practical
tion, how proximate and root causes differ, when root guidance on the next stage of root cause analysis—de-
cause analysis can be conducted, and the benefits of root termining what happened and the reasons it happened.
cause analysis. One of the benefits involves effectively Organized in a workbook format, the chapter describes
meeting Joint Commission and Joint Commission Inter- how to further define the event, identify process prob-
national requirements that relate to the management of lems, determine which care processes are involved with
sentinel events. The chapter also provides guidelines on the problem, and pinpoint the human, process, equip-
the characteristics of a thorough and credible root cause ment, environmental, and other factors closest to the
analysis and action plan. problem. The chapter also addresses how to collect and
assess data on proximate and underlying causes. It pro-
Chapter 2, “Addressing Sentinel Events in Policy and vides guidance on choosing what to measure, describes
Strategy,” describes the types of adverse events occurring indicators or measures, and guides teams through the
in health care. The Joint Commission’s Sentinel Event process of ensuring that the data collected are appropri-
Policy and requirements are listed in full, including a ate to the desired measurement. In addition, the chapter
description of reportable and reviewable events. Joint describes the process of designing and implementing
Commission International’s Sentinel Event Policy also interim changes.
is discussed. The chapter provides practical guidelines
on how an organization can develop its own sentinel Chapter 5, “Identifying Root Causes,” provides practi-
event policy, including the role that an organization’s cal guidance, through workbook questions, on identi-
culture and leadership play in risk reduction and preven- fying or uncovering the root causes—the systems that
tion. It describes the need for root cause analysis and underlie sentinel events—and the interrelationship
provides practical guidance on the early steps involved of the root causes to one another and to other health
in responding to an adverse or sentinel event. These steps care processes. Systems are explored and described,
include prompt and appropriate care provided to the pa- including human resources, information management,
tient, risk containment to minimize the possibility of a environment of care, leadership, communication, and
similar event recurring immediately with other patients, uncontrollable factors. The chapter also addresses how
event investigation so that the organization can explore to differentiate root causes and contributing factors. The
exactly what occurred and learn from the event, and most frequently occurring root causes identified by orga-
appropriate communication and disclosure to relevant nizations that experienced a medication-related sentinel
parties. event, suicide in a 24-hour care setting, and wrong-site
surgery are provided.
Chapter 3, “Preparing for Root Cause Analysis,” cov-
ers the early steps involved in performing a root cause Chapter 6, “Designing and Implementing an Action
analysis. The first of four hands-on workbook chapters, Plan for Improvement,” includes practical guidelines on
it describes how to organize a root cause analysis team, how to design and implement an action plan—the im-
define the problem, and gather the information and provement portion of a root cause analysis. During this
measurement data to study the problem. Details are stage, an organization identifies risk reduction strategies
provided about team composition and ground rules. The and designs and implements improvement strategies to
chapter also covers how to use information gleaned from address underlying systems problems. Characteristics of
the Joint Commission’s Sentinel Event Database and an acceptable action plan are provided, as is informa-
accreditation requirements to identify problem areas in tion on how to assess the effectiveness of improvement
need of root cause analysis. The chapter provides guid- efforts. The chapter concludes with information on how
ance on recording information obtained during a root to effectively communicate the results in improvement
cause analysis, conducting interviews, and gathering initiatives.
physical and documentary evidence.
xii
Chapter 7, “Tools and Techniques,” presents the • Anita Giuntoli, Associate Director, Office of Quality
tools and techniques used during root cause analysis. Monitoring, The Joint Commission
Each tool profile addresses the purpose of the tool, • Robert Katzfey, Field Director, Division of Ac-
the appropriate stage(s) of root cause analysis for the creditation and Certification Operations, The Joint
tool’s use, simple steps for success, and tips for effective Commission
use. Tools and techniques include affinity diagrams, • Sherri Woods, Sentinel Event Specialist, Office of
brainstorming, change analysis, change management, Quality Monitoring, The Joint Commsision
check sheets, control charts, failure mode and effects • Paul vanOstenberg, Senior Executive Director,
analysis, fishbone diagrams, flowcharts, Gantt International Accreditation and Standards, JCI
charts, histograms, kaizen, multivoting, operational
definitions, Pareto charts, relations diagrams, scatter Huge thanks also to our special consultants:
diagrams, SIPOC process maps, stakeholder analysis, • Diane Rydrych, Assistant Director, Division of
standard work, and value stream mapping. Preceding Health Policy, Minnesota Department of Health
the tool descriptions is a discussion of a performance • Patrice Spath, Consultant, Brown-Spath & Associ-
improvement methodology, Lean Six Sigma, that ates, and Adjunct Assistant Professor, Department
incorporates many of these tools. of Health Services Administration, University of
Alabama, Birmingham
Chapter 8, “Root Cause Analysis Case Studies from the
Field,” presents root cause analyses that resulted from JCR appreciates the valuable contributions made by Rick
real-life incidents at health care organizations. In these Morrow, Lean Six Sigma Master Black Belt, Director
studies, the tools and techniques used to dig down to the of Business Excellence, The Joint Commission, to the
root causes of the events are identified and explained. chapter on tools and techniques. Harold J. Bressler,
General Counsel, The Joint Commission, provided
Finally, the Glossary provides definitions of key terms much-appreciated assistance in clarifying the material
used throughout the book. on legal concerns. And finally, JCR would like to thank
writer John McCormack for his help in updating this
A Word About Terminology book.
The terms patient, individual served, and care recipient
all describe the individual, client, consumer, or resident References
who actually receives health care, treatment, and/or 1. Ornstein C.: Dennis Quaid files suit over drug mishap. Los
Angeles Times, Dec. 7, 2002. http://www.latimes.com/features/
services. The term care includes care, treatment, services,
health/la-me-quaid5dec05,1,1883436.story (accessed Oct. 19,
rehabilitation, habilitation, or other programs instituted 2009).
by an organization for individuals served. 2. CBS News.com: Dennis Quaid recounts twins’ drug ordeal.
60 Minutes, Aug. 28, 2008. http://www.cbsnews.com/stories/
Acknowledgments 2008/03/13/60minutes/main3936412_page3.shtml (accessed
Joint Commission Resources is grateful to the many Oct. 19, 2009).
3. Miller M., Zhan C.: Pediatric Patient Safety in Hospitals: A
content experts who have contributed to this publica-
National Picture in 2000. Pediatrics 113:1741–1746, 2004.
tion. They include our editor, Richard J. Croteau, M.D., 4. Peters G., Peters, B.: Medical Error and Patient Safety: Human
Patient Safety Advisor, Joint Commission International, Factors in Medicine. Boca Raton, FL: CRC Press, 2007.
and the following Joint Commission and JCI reviewers: 5. The Joint Commission: Failure Mode and Effects Analysis:
• Maureen Carr, Project Director, Division of Stan- Proactive Risk Reduction, Second Edition. Oakbrook Terrace,
dards and Survey Methods, The Joint Commission IL: Joint Commission Resources, 2005.
• Gerard Castro, Project Director, Office of Patient
Safety, The Joint Commission
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