Root Cause Analysis
in Health Care
Tools and Techniques
SIXTH EDITION
Includes Flash Drive!
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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Purpose of This Book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi
CHAPTER 1: Root Cause Analysis: An Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Investigating Patient Safety Events: The Need for Comprehensive Systematic Analysis . . . . . . . . . . . 1
RCA 2 in High Reliability Industries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
When Can a Root Cause Analysis Be Performed? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Variation and the Difference Between Proximate and Root Causes . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Benefits of Root Cause Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Maximizing the Value of Root Cause Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
The Root Cause Analysis and Corrective Action Plan: Doing It Right . . . . . . . . . . . . . . . . . . . . . . . 10
CHAPTER 2: Addressing Sentinel Events in Policy and Strategy . . . . . . . . . . . . . . . . . 17
The Range of Adverse Events in Health Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Signals of Risk: Close Calls and No-Harm Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
The Joint Commission’s Sentinel Event Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Reasons for Reporting a Sentinel Event to The Joint Commission . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Required Response to a Sentinel Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Joint Commission International’s Sentinel Event Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Related Joint Commission International Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Developing Your Own Sentinel Event Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Leadership, Culture, and Patient Safety Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Early Response Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Event Investigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Onward with Root Cause Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
CHAPTER 3: Preparing for Root Cause Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
STEP 1: Organize a Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
STEP 2: Define the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
STEP 3: Study the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
CHAPTER 4: Determining Proximate Causes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
STEP 4: Determine What Happened . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
STEP 5: Identify Contributing Process Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
STEP 6: Identify Other Contributing Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
STEP 7: Measure—Collect and Assess Data on Proximate and Underlying Causes . . . . . . . . . . . . . 69
STEP 8: Design and Implement Immediate Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
CHAPTER 5: Identifying Root Causes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
STEP 9: Identify Which Systems Are Involved—The Root Causes . . . . . . . . . . . . . . . . . . . . . . . . . 76
STEP 10: Prune the List of Root Causes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
STEP 11: Confirm Root Causes and Consider Their Interrelationships . . . . . . . . . . . . . . . . . . . . . 79
CHAPTER 6: Designing and Implementing a Corrective Action Plan
for Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
STEP 12: Explore and Identify Risk-Reduction Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
STEP 13: Formulate Improvement Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
STEP 14: Evaluate Proposed Improvement Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
STEP 15: Design Improvements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
STEP 16: Ensure Acceptability of the Corrective Action Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
STEP 17: Implement the Improvement Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
STEP 18: Develop Measures of Effectiveness and Ensure Their Success . . . . . . . . . . . . . . . . . . . . 105
STEP 19: Evaluate Implementation of Improvement Efforts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
STEP 20: Take Additional Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
STEP 21: Communicate the Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
CHAPTER 7: Tools and Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
What Is RPI? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
What Is Lean Six Sigma? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Affinity Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Brainstorming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Change Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Change Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Check Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Control Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Failure Mode and Effects Analysis (FMEA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Fishbone Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Gantt Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Multivoting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Operational Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Pareto Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Relations Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Run Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Scatter Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
SIPOC Process Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Stakeholder Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Standard Work . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Value Stream Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
iv
Introduction
Patient safety events can cause serious harm or death.
They can affect anyone directly or indirectly involved in
the event. To address and prevent such events, health care
organizations must unearth the root cause(s) underlying
these events and develop solutions that prevent, anticipate,
and avoid the problems from a systems perspective.
Today, quality-of-care issues are a problem for health
care organizations around the world. The World Health
Organization (WHO) estimates that of 421 million
hospitalizations globally each year more than 42 million
patients will suffer an adverse event.3 And the problem is
certainly not limited to developing nations with small or
underfunded health care systems. The WHO also estimates
that on average in the United Kingdom there is an incident
of patient harm every 35 seconds, and that up to 15%
of hospital expenditures in Europe go to treating
safety accidents.4
Despite remarkable advances in almost every contemporary field of health care, system vulnerabilities and process
flaws result in harm to patients. In fact, Sutcliffe, Paine,
and Pronovost assert that “the hallmark of an HRO [high
reliability organization] is not that it is error free but that
errors do not disable it. In a health care context, an HRO
would not be error free, it would be harm free.”1
Although such reports and chart reviews illuminate the
problem, it is impossible to know how many patients suffer
as a result of health care system failures. Even a single
patient safety event is cause for concern. Such events can
result in tragedy for patients and their families, add costs to
an already overburdened health care system, adversely affect
the public’s perception of an organization, and lead to
litigation. They can also deeply impact dedicated health
care professionals concerned for their patients.
System and process weaknesses are not often immediately
apparent and require investigation. This is particularly true
for sentinel events, patient safety events not primarily related
to the natural course of the patient’s illness or underlying
condition that reach a patient and result in death, permanent harm, or severe temporary harm.
The prevalence of patient safety events was thrust into
the limelight with the watershed report To Err Is Human:
Building a Safer Health System, published in 2000 by the
Institute of Medicine (IOM), now the National Academies
of Sciences, Engineering, and Medicine. The IOM report
was just the beginning. More reports followed, emphasizing the need to improve health care quality in the
United States. For example, researchers at Johns Hopkins
Children’s Center and the US Agency for Healthcare
Research and Quality reviewed 5.7 million records of
patients under 19 years old from 27 states who were hospitalized in 2000. The researchers identified 52,000 as being
harmed by unsafe medical care during their hospital stays,
with 4,483 suffering a fatal injury.2
Health care organizations can address flawed systems only
when they consider this question: Why do these failures
continue to occur?
To answer this question, an organization will need to
perform a comprehensive systematic analysis. The most
commonly used form of comprehensive systematic analysis
among Joint Commission–accredited organizations is root
cause analysis (RCA)—a process identifying the basic or
causal contributing factor(s) underlying variation in
performance, including the occurrence or possible occurrence of a sentinel event. Organizations can use root cause
analysis to deliver safer care, uncovering the factors that
lead to patient safety events.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Although health care organizations in the United States
often use root cause analysis to help improve quality and
attain accreditation, such analysis has many broader applications around the world. Whether delivered in New York
City or Dubai or Singapore, organizations can use root
cause analysis to improve processes and provide highquality care.
Pharmacists to institute a mandatory incident reporting
program for all pharmacies in Ontario.7
• In February 2017 the state of Minnesota reported that
106 patients in that state were seriously injured and
another 4 patients died as a result of patient safety events
during 2016.8
• In June 2017 a Pennsylvania jury awarded $870,000 to
a man after a surgeon removed the wrong testicle in a
2013 procedure.9
The Current Health Care Environment
Health care continues to experience dramatic change.
Health care organizations evolve constantly due to
changes in reimbursement, new technology, regulatory
requirements, and staffing levels. These modifications
cause policies and procedures to change often. As health
care organizations become more complex, their systems
and processes are increasingly interdependent. This interdependence increases the risk of failures and makes the
recovery from failure difficult. Clinical and support staff
workloads grow heavier, resulting in greater stress,
fatigue, and burnout for many health care professionals.
Caregivers work in new settings and perform new functions, sometimes with only minimal training. Maintaining
consistency in processes and systems becomes challenging
and leads to variation. Often, this variation results in
increased risk to patients.
The above examples are only a few of the serious patient
safety events that have attracted media attention in recent
years. These events cast a shadow on the public’s trust of
health care. Stakeholders, including patients, justifiably
ask, “What’s going on?” Failure detection, reduction, and
prevention strategies are receiving new impetus as the
health care community recognizes the value of a proactive
approach to reducing risk.
Root cause analysis is one such approach. Historically used
to investigate sentinel events, root cause analysis shows great
promise as a proactive tool. Increasingly, health care organizations are using this methodology to investigate close calls,
no-harm patient safety events, and other signals of risk.
Health care organizations no longer have to wait until after
a sentinel event occurs to perform a root cause analysis.
Media reports about patient safety events occur with
increasing regularity, including the following examples:
• In September 2013 researchers estimated that the
number of premature deaths associated with preventable
harm to patients in US hospitals was more than 400,000
per year. This makes patient safety events the third
leading cause of death in the United States. Incidents
resulting in serious patient harm were estimated to be
10–20 times more common than lethal harm.5
• In May 2016 a New York outpatient surgical clinic
settled for an undisclosed amount and accepted
responsibility in the death of comedian Joan Rivers,
who stopped breathing during a laryngoscopy procedure
in 2014.6
• In October 2016 the parents of an 8-year-old Canadian
boy filed a $4 million lawsuit against an Ontario
pharmacy for its role in a medication error that resulted
in their son receiving a lethal dose of the muscle relaxant
baclofen. The incident and an ensuing petition drive led
by the boy’s mother prompted the Ontario College of
When an adverse outcome, a sentinel event, or a cluster
of less serious incidents or close calls occurs, organizations must develop an understanding of the contributing
factors and protective factors (those factors that allowed a
problem to be identified and corrected or “things that went
right”) and the interrelationship of those factors. Next,
the organization must implement a corrective action plan
that augments and supports protective factors to reduce
system vulnerabilities focusing on how to enable successful
processes more often. An approach that focuses on enabling
successful processes will help improve the system’s resilience,
the degree to which it continuously prevents, detects, mitigates, or ameliorates hazards or incidents.10
Purpose of This Book
Root Cause Analysis in Health Care: Tools and Techniques,
Sixth Edition, is intended to help health care organizations
prevent systems failures by using root cause analysis to do
the following:
vi
Introduction
• Identify causes and contributing factors of a sentinel
event or a cluster of incidents.
• Identify system vulnerabilities that could lead to
patient harm.
• Implement strong and corrective risk-reduction strategies
that decrease the likelihood of a recurrence of the event
or incidents.
• Determine if corrective actions are successful
and sustained.
analysis to minimize the possibility of patient safety events
and thereby to improve the care, treatment, and services
provided at their facilities.
What’s New in This Edition
This sixth edition provides updated statistics and introduces new concepts and tools associated with RCA2:
Improving Root Cause Analyses and Actions to Prevent Harm,
the National Patient Safety Foundation’s in-depth report
focusing on the techniques and processes of how root cause
analyses can best prioritize system flaws and vulnerabilities
and make improvements to successfully improve patient
care in all health care settings. This goal is accomplished
through the implementation and measurement of remedial actions and processes. This book also includes new and
revised tools aligned with The Joint Commission’s Robust
Process Improvement® (RPI®), a set of process improvement
strategies adopted by The Joint Commission to help organizations improve business processes and clinical outcomes.
Root cause analysis is an effective technique most
commonly used after an error has occurred to identify
underlying causes. Failure mode and effects analysis (FMEA)
is a proactive technique used to prevent process and
product problems before they occur.11 Health care organizations should learn both techniques to reduce the likelihood
of adverse events.
Root Cause Analysis in Health Care: Tools and Techniques,
Sixth Edition, provides health care organizations worldwide with information on The Joint Commission’s Sentinel
Event Policy and safety-related requirements. (For the most
up-to-date information on the policy and requirements,
see the “Quality and Patient Safety” section on your Joint
Commission ConnectTM extranet site.) It also describes the
Sentinel Event Policy and related requirements of Joint
Commission International. The book includes examples
that guide the reader through application of root cause
analysis to the investigation of specific types of sentinel
events, such as medication errors, suicide, treatment delay,
and elopement.
Overview of Contents
Root Cause Analysis in Health Care: Tools and Techniques,
Sixth Edition, provides health care organizations with
practical, how-to information on conducting a root cause
analysis and effective corrective action plan. Twenty-one
steps are described in Chapters 3 through 6. Teams
conducting a root cause analysis might not follow these
steps in a sequential order. Often, numerous steps will
occur simultaneously, or the team will return to earlier
steps before proceeding to the next step. It is crucial for
teams to customize or adapt the process to meet the unique
needs of the team and organization.
This publication provides and explains The Joint
Commission’s framework for conducting a root cause
analysis. It also helps organizations do the following:
• Identify the processes that could benefit from root cause
analysis.
• Conduct a thorough and credible root cause analysis.
• Interpret analysis results.
• Develop and implement a strong corrective action plan
for improvement.
• Assess the effectiveness of risk-reduction efforts.
• Integrate root cause analysis with other programs.
Appropriate tools for use in each stage of root cause analysis
appear in each chapter in the form of checklists, matrices,
and more. In the e-book version, internal links allow you to
easily search for terms and navigate across chapters. Links
even take you directly to the downloadable, customizable
tools (in the print version, these tools are delivered on a
flash drive).
A chapter-by-chapter description of the contents follows.
Chapter 1, “Root Cause Analysis: An Overview,” takes a
holistic look at root cause analysis. It describes variation
and developing causal statements, how proximate and root
Even without the occurrence of an adverse event, health
care organizations should embrace the use of root cause
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
causes differ, when root cause analysis can be conducted,
and the benefits of root cause analysis. One of the benefits
involves effectively meeting Joint Commission and Joint
Commission International requirements that relate to the
management of sentinel events. The chapter also provides
guidelines on the characteristics of a thorough and credible
root cause analysis and corrective action plan and emphasizes the role of leadership and its impact on high reliability.
In addition, the chapter describes the process of designing
and implementing interim changes.
Chapter 5, “Identifying Root Causes,” provides practical
­guidance on identifying or uncovering the root causes—
the systems that underlie sentinel events—and the inter­
relationship of the root causes to one another and to other
health care processes. The chapter explores and describes
systems, including human resources, information management, environment of care, leadership, communication,
and uncontrollable factors. The chapter also addresses how
to differentiate root causes and contributing factors.
Chapter 2, “Addressing Sentinel Events in Policy and Strategy,”
describes the types of adverse events occurring in health
care. It lists in full The Joint Commission’s Sentinel Event
Policy and requirements, including The Joint Commission’s
sentinel event definition. The chapter also discusses Joint
Commission International’s Sentinel Event Policy and
related requirements. The chapter provides practical
guidelines on how an organization can develop its own
sentinel event policy, including the role that an organization’s culture and leadership play in risk reduction and
prevention, which is part of a patient safety system. It also
describes the need for root cause analysis and provides practical guidance on the early steps involved in responding to
an adverse or sentinel event.
Chapter 6, “Designing and Implementing a Corrective Action
Plan for Improvement,” includes practical guidelines on how
to design and implement a corrective action plan—the
improvement portion of a root cause analysis. During this
stage, an organization identifies risk-reduction strategies,
designs and implements improvement strategies to address
underlying systems problems, and makes a determination
of the strength of the action. The chapter includes characteristics of an acceptable corrective action plan, as well as
information on how to assess the effectiveness of improvement efforts. The chapter concludes with information on
how to effectively communicate the results in improvement
initiatives.
Chapter 3, “Preparing for Root Cause Analysis,” covers the
early steps involved in performing a root cause analysis. The
first of four hands-on step-by-step chapters, it describes
how to organize a root cause analysis team, define the
problem, and gather the information and measurement data
to study the problem. The chapter provides details about
team composition and ground rules. It also covers how
to use information from The Joint Commission’s Sentinel
Event Database and accreditation requirements to identify problem areas needing root cause analysis. The chapter
provides guidance on recording information obtained
during a root cause analysis, conducting interviews, and
gathering physical and documentary evidence.
Chapter 7, “Tools and Techniques,” presents the tools and
techniques used during root cause analysis. Each tool
profile addresses the purpose of the tool, the appropriate
stage(s) of root cause analysis for the tool’s use, simple steps
for success, and tips for effective use. The chapter profiles
21 tools: affinity diagrams, brainstorming, change analysis,
change management, check sheets, control charts, failure
mode and effects analysis, fishbone diagrams, flowcharts,
Gantt charts, histograms, multivoting, operational definition, pareto chart, relations diagram, run charts, scatter
diagrams, SIPOC process maps, stakeholder analysis,
standard work, and value stream mapping. A discussion of
a performance improvement methodology, Lean Six Sigma,
and change management incorporates many of these tools
and precedes the tool descriptions. References to these
many tools appear in Chapters 3 through 6 in the “Tools
to Use” box appearing in each of these chapters.
Chapter 4, “Determining Proximate Causes,” provides practical guidance on the next stage of root cause analysis—
determining what happened and the reasons it happened.
The chapter describes how to further define the event,
identify process problems, determine which care processes
are involved with the problem, and pinpoint the human,
process, equipment, environmental, and other factors
closest to the problem. The chapter also addresses how to
collect and assess data on proximate and underlying causes.
The Joint Commission’s Framework for a Root Cause
Analysis and Corrective Action Plan appears as the
viii
Introduction
References
Appendix. This framework and its 24 assessment questions,
referenced throughout Chapters 3 through 6, provides
a solid foundation for root cause analyses and corrective
action plans. A downloadable, editable version appears on
the flash drive.
1. Sutcliffe KM, Paine L, Pronovost PJ. BMJ Qual Saf Published
Online First: 21 Mar 2016 doi:10.1136bmjqs-2015-004698.
2. Miller MR, Zhan C. Pediatric patient safety in
hospitals: A national picture in 2000. Pediatrics. 2004
Jun;113(6):1741–1746.
Finally, the Glossary provides definitions of key terms used
throughout the book.
3. Jha AK, Larizgoitia I, Audera-Lopez C, et al. The global burden
of unsafe medical care: Analytic modelling of observational
studies. BMJ Qual Saf. 2013;22:809–815.
A Word About Terminology
4. Patient Safety: Making health care safer. Geneva: World Health
Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.
The terms patient, individual served, and care recipient all
describe the individual, client, consumer, or resident who
actually receives care, treatment, and/or services. The term
care includes care, treatment, services, rehabilitation, habilitation, or other programs instituted by an organization for
individuals served.
5. James JT. A new evidence-based estimate of patient
harms associated with hospital care. J Patient Saf. 2013
Sep;9(3):122–128.
6. The New York Times. Settlement Reached in Joan Rivers
Malpractice Case. Santora, M. May 12, 2016. Accessed Jun 21,
2017. https://www.nytimes.com/2016/05/13/nyregion
/settlement-reached-in-joan-rivers-malpractice-case.html?_r=0.
Acknowledgments
7. Hamilton Spectator. Ontario pharmacists to be required to report
errors after boy’s death. Hudes, S. Jun 20, 2017. Accessed Jun 21,
2017. https://www.thespec.com/news-story/7381446-ontario
-pharmacists-to-be-required-to-report-errors-after-boy-s-death.
Joint Commission Resources is grateful to the many
content experts who have contributed to this publication,
including the following individuals:
8. Minnesota Department of Health (MDH). Adverse Health Events
in Minnesota: 13th Annual Public Report. St. Paul: MDH: 2015.
Accessed Jun 21, 2017. http://www.health.state.mn.us
/patientsafety/ae/2015ahereport.pdf.
Dawn Allbee; Anne Marie Benedicto; Kathy Brooks;
Lisa Buczkowski, RN, MS; Gerard Castro, PhD, MPH;
Patty Chappell; Adam Fonseca, MHA, RPI, BB; Jessica
Gacki-Smith, MPH; Brian D. Patterson, LSS, MBB;
Jennifer Guowen Zhu.
9. International Business Times. Doctor Removes Wrong Testicle
From Pennsylvania Man, Jury Awards $870,000 In Damages.
Ghosh, S. Jun 19, 2017. Accessed Jun 21, 2017. http://www
.ibtimes.com/doctor-removes-wrong-testicle-pennsylvania
-man-jury-awards-870000-damages-2554137.
In addition, JCR would like to thank writer James Foster
for his help in revising this book.
10. World Health Organization (WHO). More Than Words:
Conceptual Framework for the International Classification for
Patient Safety: Final Technical Report, ver. 1.1. Geneva: WHO,
2009. Accessed Jul 12, 2017. http://www.who.int/patientsafety
/taxonomy/icps_full_report.pdf.
11. The Joint Commission. Failure Mode and Effects Analysis in
Health Care: Proactive Risk Reduction, 3rd ed. Oak Brook, IL:
Joint Commission Resources, 2010.
ix
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
x
CHAPTER
1
Root Cause Analysis: An Overview
What Is Root Cause Analysis?
Learning Objectives
Root cause analysis is a process for identifying the basic
or causal factor(s) underlying variation in performance.
Variation in performance can (and often does) produce
unexpected and undesired adverse outcomes, including the
occurrence or risk of a sentinel event. The Joint Commission
defines sentinel event as a patient safety event (not primarily
related to the natural course of the patient’s illness or
under­lying condition) that reaches a patient and results in
death, permanent harm, or severe temporary harm.*
• Understand the need for comprehensive
systematic analysis of sentinel events and other
adverse outcomes
• Learn how leadership and organizational
commitment to constant improvement lead to a
high reliability organization
• Understand the most effective timing for
performing a root cause analysis plan
• Learn the importance of improving systems to
prevent sentinel events or problems
Similarly, Joint Commission International (JCI) defines
sentinel event as an unanticipated occurrence involving
death or serious physical or psychological injury—serious
physical injury specifically includes loss of limb or function. A root cause analysis focuses primarily on systems and
processes, not individual performance. To be successful,
the objective of an RCA must not be to assign individual
blame. Rather, through the RCA process, a team works to
understand a process or processes within the context of a
system, the causes or potential causes of variation that can
lead to error, and identify process changes that would make
variation less likely to recur.
• Learn the basics of root cause analysis (RCA),
the most common method of comprehensive
systematic analysis
• Know how RCA and corrective action plans relate
to The Joint Commission’s Sentinel Event Policy
Investigating Patient Safety Events: The Need
for Comprehensive Systematic Analysis
The Joint Commission’s Sentinel Event Policy requires
accredited health care organizations to conduct a comprehensive systematic analysis in the wake of a sentinel event.
Comprehensive systematic analysis seeks to go beyond
individual performance issues to determine how gaps in
policies and safety systems may have contributed to an
adverse event and to identify strong corrective actions to
policies and procedures that may prevent similar events
from occurring in the future. The Joint Commission
reviews methods of comprehensive systematic analysis on
a case-by-case basis to determine their credibility, thoroughness, and acceptability. The Joint Commission also provides
advice and resources to institutions to assist them in
assessing analytical tools. However, root cause analysis
(RCA) is by far the most common method and is the
method preferred by The Joint Commission.
A root cause is the most fundamental reason (or one of
several fundamental reasons) a failure, or a situation in
which performance does not meet expectations, occurs.
In common usage, the word cause suggests responsibility
* Severe temporary harm is critical, potentially life-threatening harm lasting
for a limited time with no permanent residual, but requires transfer to a
higher level of care/monitoring for a prolonged period of time, transfer to
a higher level of care for a life-threatening condition, or additional major
surgery, procedure, or treatment to resolve the condition. Adapted from
Healthcare Performance Improvement, LLC. The HPI SEC & SSER
Patient Safety Measurement System for Healthcare, rev. 2. Throop C,
Stockmeier C. May 2011. Accessed May 12, 2017. http://www.pressganey
.com/docs/default-source/default-document-library/hpi-white-paper---sec
-amp-sser-measurement-system-rev-2-may-2011.pdf.
1
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
or a factor to blame for a problem. In the context of an
RCA, however, the use of the word cause does not imply an
assignment of blame. Instead, the cause refers to a relationship or potential relationship between certain factors that
enable a sentinel event to occur. The focus in an RCA is
on a positive, preventive approach to system and process
changes following a sentinel event, a close call, or a cluster
of less serious yet potentially harmful incidents.
Sidebar 1-1.
Root Cause Analysis Case Example
A 16-year-old patient came to the hospital to deliver
her baby. During the process of her care, an infusion intended exclusively for the epidural route was
connected to the patient’s peripheral intravenous line
and infused by pump. The patient experienced cardiovascular collapse. A cesarean section resulted in the
delivery of a healthy infant, but the medical team was
unable to resuscitate the mother.
As shown in Sidebar 1-1, root cause analyses can do more
than discover that “A caused B.” The process also can help
an organization determine that “if we change A because
we had a problem with it, we can reduce the possibility
of B recurring or in fact prevent B from occurring in the
first place.”
The media attention surrounding the error accelerated
through the national provider and safety community
when the nurse was charged with a criminal offense.
These events set in motion intense internal and
external scrutiny of the hospital’s medication and
safety procedures.
RCA is a powerful and useful tool that can help health
care organizations around the world reduce errors and
move quality efforts forward. However, health care organization leaders must realize that RCA is not a panacea but
one tool that should be used in conjunction with others
to improve care.
The organization conducted a root cause analysis to
further understanding about latent systems gaps and
process failure modes. A team conducted a one-week
evaluation of the medication use system and the organization’s current environment, systems and processes,
staffing patterns, leadership, and culture to help shape
the recommended improvements. Team members identified performance-shaping factors for each of the four
proximate causes of the event.
RCA2 in High Reliability Industries
As mentioned in the Introduction, the National Patient
Safety Foundation released in 2015 RCA2: Improving Root
Cause Analyses and Actions to Prevent Harm, an in-depth
report focusing on the techniques and processes of how root
cause analyses can best prioritize system flaws and vulnerabilities and make improvements to successfully improve
patient care in all health care settings. Industries that are
regarded as highly reliable, such as nuclear power or the
aerospace industry, employ RCA2 methodology to investigate adverse events. In the nuclear power and aerospace
industries, sentinel events are rare because they have been
anticipated. These high reliability industries have adopted a
systems approach, in which errors are viewed as an expected
part of the workplace, the result of a chance misalignment
of weaknesses in the underlying system.1 (Imagine a stack of
slices of Swiss cheese. Each slice has holes in different
places, thus only if a hole in each slice aligned perfectly
with a hole in all the other slices could an object pass
through the entire stack. The Swiss cheese model shown in
Figure 1-1, page 3, represents how an error could possibly
penetrate multiple layers of barriers, defenses, and safeguards in a system.)
Although the hospital’s organizational learning was
painful, this event offered an opportunity for increasing
organizational competency and capacity for designing
and implementing patient safety. The organization
implemented structures and processes, including safety
nets and fail-safe mechanisms, to promote safer behavioral choices for providers.
The hospital took a number of clinical steps to improve
the safety of medication administration, including
removing the barriers to scanning medication bar
codes, implementing consistent scanning-compliance
tracking, and providing teamwork training for all nursing
and physician staff practicing in the birth suites.
Source: Smetzer J, et al. Shaping systems for better behavioral
choices: Lessons learned from a fatal medication error. Jt Comm J Qual
Patient Saf. 2010 Apr;36(4):152–163.
High Reliability Characteristics
One of the distinguishing characteristics of high reliability
industries and organizations is an organizational commitment to constant improvement. This commitment starts at
the leadership level. Senior managers and boards in these
2
CHAPTER 1
| Root Cause Analysis: An Overview
Figure 1-1. Swiss Cheese Model
Hazards
Losses
The Swiss cheese model shows how an error could penetrate multiple layers of defenses, barriers,
and safeguards in a system.
Source: Reason J.: The Human Contribution: Unsafe Acts, Accidents and Heroic Recoveries, 1st Edition. Farnham, England:
Ashgate Publishing, 2008. Reproduced by permission of Taylor and Francis Books UK.
organizations create a culture of safety by encouraging trust,
reporting, and improvement at all levels of the organization. Leaders lead by example through their commitment
to fairness, accountability, and transparency. By giving individual workers and team members the confidence that the
reporting of errors and relating of their concerns will not
be used against them, that reporting problems will result in
improvements and corrective action, and that they will be
dealt with honestly, leaders can encourage workers to buy in
to changes and create a virtuous cycle. In addition, leaders
in high reliability organizations also ensure that there is
organizational support for performance improvement
learning so that its workforce is able to find solutions to the
improvement opportunities they find, furthering the cycle
of improvement and transformation.
potential dangers, risk factors, and problematic behavior.
In this way, safety becomes a modus operandi. Constant
improvement becomes a cultural norm within the organization. The ongoing search for ways to improve reliability becomes integrated in the organization’s daily work,
becoming simply “how we work.”
Leadership
Again, the role of leadership in this process cannot be
overstated. Leadership sets the goal of zero error or zero
harm and promotes a collective mindfulness of safety and
reliability. However, the commitment to zero harm must
include an honest, transparent accounting of the organization’s current level of reliability. In addition, leaders
must emphasize the value of reporting errors, close calls,
and unsafe conditions because the information and data
collected in the investigation of errors is invaluable to an
organization that seeks to identify, learn from, and correct
its mistakes. A high reliability organization acknowledges
what it does not know and seeks to know as much as it can,
particularly about situations or incidents in which it falls
short of optimal performance. Compiling and analyzing
Performance Improvement
RCA2 methods are also an integral part of the process of
becoming a high reliability organization. Shifting the focus
of investigation from “Who is responsible?” to “What needs
to change?” encourages workers trained in performance
improvement techniques to be on constant lookout for
3
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
information and data across many adverse events, close
calls, and unsafe conditions enables a proactive assessment
of safety policies and procedures. The goal is to become
proactive, to identify potential risks as far upstream as
possible and work to mitigate or eliminate them, rather
than to react to each event after the fact.
analysis.2 The goal of the root cause analysis is to produce
a corrective action plan identifying the strategies the organization intends to implement to improve the likelihood
of favorable outcomes and reduce the risk of similar events
occurring in the future.
Root cause analysis is also used increasingly by organizations as one step of a proactive risk-reduction effort
using failure mode and effects analysis (FMEA). FMEA is
a proactive, prospective approach used to prevent process
and product problems before they occur. It provides a
look not only at what problems could occur—the failure
modes—but also at how severe the effects of those problems
could be. The goal is to improve the likelihood of favorable
outcomes and prevent harm to patients (see chapters 6 and
7 for more information). One step of FMEA involves identifying the root causes of the failure modes.3 At this point in
the process, the FMEA team can use the RCA approach.
Techniques and Strategies
The Joint Commission’s Robust Process Improvement®
(RPI®) system embraces these values. Through RPI, leaders
and workers are trained in Lean Six Sigma analysis and
improvement techniques and Change Management® strategies. Use of these techniques and strategies empowers
workers to identify problems in their daily work. The
tools enable them to analyze those problems and conceive
possible improvements. These improvements are tailored to
the culture and environment of the organization. Finally,
the tools equip individuals with skills and knowledge to
implement improvements and maintain progress.
Sidebar 1-2, pages 5–6, presents a frequency/severity matrix
organization for prioritizing safety-related problems. The
matrix identifies four categories of severity that apply to
both actual patient safety events and to close calls. Use of
the matrix can help the organization decide how to use its
resources to determine which risks to analyze and mitigate
first. This determination can help organizations decide
which adverse events, close calls, or hazards require a root
cause analysis. In this matrix, if a patient safety event gets a
high score in the severity category and a high probability of
occurring again, then a root cause analysis is necessary.4
Commitment to Excellence
An honest and transparent organization builds credibility
both internally and with customers and the public. An
organization committed to zero harm, that seeks to identify
risks and failures at all levels so that it can learn from them,
that doesn’t settle for simple answers to complex questions,
that understands the increased risk that comes with changes
in operations, that is committed to learning from its
mistakes in an open and honest way, and that values
expertise at every level and invests in the development
of its workforce is on its way to becoming a high
reliability organization.
Domestic and International Requirements
Both The Joint Commission, which accredits health care
organizations in the United States, and Joint Commission
International (JCI), which accredits health care organizations in countries other than the United States, have
a Sentinel Event Policy and standards related to sentinel
events. For example, JCI Quality Improvement and Patient
Safety (QPS) standards require each accredited organization
to establish an operational definition of a sentinel event and
a process for the in-depth analysis of such events.
When Can a Root Cause Analysis
Be Performed?
Historically, organizations have most commonly used root
cause analysis retrospectively—to probe the reasons for a bad
outcome or for failures that have already occurred. Root
cause analysis can also be used by organizations to probe
a close call event or pattern of events or as part of other
performance improvement redesign initiatives, such as
gaining an understanding of variations observed in systematically collected data. The best RCAs address the entire
process and all support systems involved in a specific event
to minimize overall risk associated with that process, as well
as the recurrence of the event that prompted the root cause
When developing the definition of sentinel event,
JCI-accredited organizations must include at least those
events that are described in the sentinel event standard
within the JCI standards manuals. Such events include
4
CHAPTER 1
| Root Cause Analysis: An Overview
Sidebar 1-2. Frequency/Severity Matrix for Prioritizing Safety-Related Problems
The Safety Assessment Code (SAC) Matrix
The Severity Categories and the Probability Categories that are used to develop the Safety Assessment Codes (SACs)
for adverse events and close calls are presented in the following, and are followed by information on the SAC Matrix.
1. Severity Categories
a. Key factors for the severity categories are extent of
injury, length of stay, level of care required for remedy,
and actual or estimated physical plant costs. These four
categories apply to actual adverse events and potential
events (close calls). For actual adverse events, assign
severity based on the patient’s actual condition.
b. If the event is a close call, assign severity based on
a reasonable “worst case” systems-level scenario.
NOTE: For example, if you entered a patient’s room
before they were able to complete a lethal suicide
attempt, the event is catastrophic, because the
reasonable “worst case” is suicide.
Catastrophic
Major
Death or major permanent loss of function (sensory, motor,
physiologic, or intellectual) not related to the natural course of the
patient’s illness or underlying condition (that is, acts of commission
or omission). This includes outcomes that are a direct result of injuries
sustained in a fall; associated with an unauthorized departure from an
around-the-clock treatment setting; or the result of an assault or other
crime. Any of the adverse events defined by the Joint Commission as
reviewable “Sentinel Events” should also be considered in this category.
Patients with Actual or Potential:
Permanent lessening of bodily functioning (sensory, motor, physiologic, or
intellectual) not related to the natural course of the patient’s illness or
underlying conditions (that is, acts of commission or omission) or any
of the following:
a. Disfigurement
b. Surgical intervention required
c. Increased length of stay for three or more patients
d. Increased level of care for three or more patients
Visitors: A death or hospitalization of three or more visitors
Visitors: Hospitalization of one or two visitors
Staff: A death or hospitalization of three or more staff*
Staff: Hospitalization of one or two staff or three or more staff experiencing lost time or restricted duty injuries or illnesses
Equipment or facility: Damage equal to or more than $100,000*†
Moderate
Minor
Patients with Actual or Potential: Increased length of stay or increased
level of care for one or two patients
Patients with Actual or Potential: No injury nor increased length of stay
nor increased level of care
Visitors: Evaluation and treatment for one or two visitors (less than
hospitalization)
Visitors: Evaluated and no treatment required or refused treatment
Staff: Medical expenses, lost time, or restricted duty injuries or illness for
one or two staff
Staff: First aid treatment only with no lost time nor restricted duty injuries
nor illnesses
Equipment or facility: Damage more than $10,000 but less than
$100,000†‡
Equipment or facility: Damage less than $10,000 or loss of any utility
without adverse patient outcome (for example, power, natural gas, electricity, water, communications, transport, heat and/or air conditioning)†‡
* Title 29 Code of Federal Regulations (CFR) 1960.70 and 1904.8 requires each federal agency to notify the Occupational Safety and Health Administration
(OSHA) within 8 hours of a work-related incident that results in the death of an employee or the in-patient hospitalization of three or more employees.
Volunteers are considered to be noncompensated employees.
The Safe Medical Devices Act of 1990 requires reporting of all incidents in which a medical device may have caused or contributed to the death, serious
injury, or serious illness of a patient or another individual.
†
The effectiveness of the facilities disaster plan must be critiqued following each implementation to meet The Joint Commission’s Environment
of Care Standards.
‡
continued
5
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Sidebar 1-2. Frequency/Severity Matrix for Prioritizing Safety-Related Problems continued
2. Probability Categories
a. Like the severity categories, the probability categories
apply to actual adverse events and close calls.
b. In order to assign a probability rating for an adverse
event or close call, it is ideal to know how often it
occurs at your facility. Sometimes the data will be easily
available because they are routinely tracked (for
example, falls with injury, adverse drug events (ADEs),
and so forth). Sometimes, getting a feel for the probability of events that are not routinely tracked will mean
asking for a quick or informal opinion from staff most
familiar with those events. Sometimes it will have to be
your best educated guess. Like the severity categories,
the probability categories apply to actual adverse events
and close calls.
c. In order to assign a probability rating for an adverse
event or close call, it is ideal to know how often it occurs
at your facility. Sometimes the data is easily available
because the events are routinely tracked (for example,
falls with injury, ADEs, and so forth). Sometimes, getting
a feel for the probability of events that are not routinely
tracked will mean asking for a quick or informal opinion
from staff most familiar with those events. Sometimes it
will have to be the best educated guess.
(1) Frequent – Likely to occur immediately or within a
short period (may happen several times in 1 year).
(2) Occasional – Probably will occur (may happen
several times in 1 to 2 years).
(3) Uncommon – Possible to occur (may happen sometime in 2 to 5 years).
(4) Remote – Unlikely to occur (may happen sometime
in 5 to 30 years).
3. How the Safety Assessment Codes (SAC) Matrix Looks
Probability and
Severity
Catastrophic
Major
Moderate
Minor
Frequent
3
3
2
1
Occasional
3
2
1
1
Uncommon
3
2
1
1
Remote
3
2
1
1
4. How the SAC Matrix Works
When a severity category is paired with a probability
category for either an actual event or close call, a ranked
matrix score (3 = highest risk, 2 = intermediate risk,
1 = lowest risk) results. These ranks, or SACs, can then be
used for doing comparative analysis and for deciding who
needs to be notified about the event.
5. Reporting
a. All known reporters of events, regardless of SAC score
(one, two, or three), must receive appropriate and
timely feedback.
b. The Patient Safety Manager, or designee, must refer
adverse events or close calls related solely to staff,
visitors, or equipment and/or facility damage to relevant
facility experts or services on a timely basis, for assessment and resolution of those situations.
The matrix and other information above can help organizations decide which adverse events, close calls, or hazards
require a root cause analysis.
Source: Adapted from Department of Veterans Affairs, Veterans Health Administration, VHA Patient Safety Improvement Handbook 1050.01, May 23, 2008.
Accessed March 4, 2017. http://cheps.engin.umich.edu/wp-content/uploads/sites/118/2015/04/Triaging-Adverse-Events-and-Close-Calls-SAC.pdf
6
CHAPTER 1
unanticipated death unrelated to review under JCI standards, such as unanticipated death related to the natural
course of the patient’s illness or underlying condition;
major permanent loss of function unrelated to the natural
course of the patient’s illness or underlying condition;
wrong-site, wrong-procedure, wrong-patient surgery; transmission of a chronic or fatal disease or illness as a result of
infusing blood or blood products or transplanting contaminated organs or tissues; infant abduction; rape, workplace
violence leading to death or permanent loss of function, or
homicide on the organization’s property.
| Root Cause Analysis: An Overview
Sidebar 1-3.
Investigating Multiple Patient
Safety Events
Although root cause analysis (RCA) is associated
frequently with the investigation of a single sentinel
event, the methodology also can be used to determine
the cause of multiple occurrences of low-harm events.
For example, 40 Danish community pharmacies worked
together, using RCA, to gain insight into medication
errors, a problem that can result in serious consequences for patients.
The root cause analysis included investigation of 401
errors, many of which had potential clinical significance,
even though each error did not necessarily result in
harm. Analyzed as a cluster, however, the RCA resulted
in the identification of four common medication
error causes1:
For organizations based in the United States, Joint
Commission standards require the organization to have an
organizationwide, integrated patient safety program within
its performance improvement activities (see the “Patient
Safety Systems” chapter in your program’s Comprehensive
Accreditation Manual).
1. Illegible handwritten prescriptions
2. Similar packaging or names, or misleading presentation of strength and dosage
Particularly, organizations are required to conduct thorough and credible comprehensive systematic analyses (for
example, root cause analyses) in response to sentinel events.
RCA is the most commonly used form of comprehensive
systematic analysis used by Joint Commission–accredited
organizations to comply with this requirement.
3. Ineffective control of prescription label and medicine
4. Lapsed concentration caused by interruptions.
Reference:
1. Knudsen P, et al. Preventing medication errors in community
pharmacy: Root-cause analysis of transcription errors. Qual Saf Health
Care. 2007 Aug;16(4):285–290.
Both JCI– and Joint Commission–accredited organizations
are expected to identify and respond appropriately to all
sentinel events that occur in the organization or that are
associated with services that the organization provides or
provides for. Appropriate response includes conducting a
timely, thorough, and credible comprehensive systematic
analysis; developing a strong corrective action plan designed
to implement improvements to reduce risk; implementing
the improvements; and monitoring the effectiveness and
sustainability of those improvements. (See Sidebar 1-3 for
a discussion of multiple events.)
To meet these challenges, organizations must understand not only the proximate causes, or active failures (the
apparent, seemingly obvious reasons an error occurred) but
also the underlying causes, or latent conditions (the aspects of
a process that can allow an error to occur), and the interrelationship of the two. As shown in Figure 1-2, page 8,
active failures are only the “tip of the iceberg”—that which
is visible or proximal to the patient—while latent conditions lurk unseen “underwater,” posing a hidden potential danger. Root cause analysis helps organizations delve
beneath the proximate causes to find the underlying causes
of a sentinel event.
Variation and the Difference Between
Proximate and Root Causes
Whether addressing a sentinel event or a cluster of less
serious low-harm or close call events, root cause analysis in
all environments provides two challenges:
1. To understand why the event occurred
2. To prevent the same or a similar event from occurring in
the future through prospective process design or redesign
Conducting an RCA has significant resource implications.
A team approach, involving a full range of disciplines and
departments in the process being studied, is mandatory, as
will be described in Chapter 3. Organizations therefore will
want to conduct root cause analysis principally to explore
those events or possible events with a significant negative
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Understand Common-Cause Variation
Figure 1-2. The Relationships Between a
Sentinel Event and Its Causes
Common-cause variation, although inherent in every
process, is a consequence of the way a process is designed to
work. An example might be an organization examining the
length of time required by the emergency department to
obtain a routine radiology report. The time may vary
depending on how busy the radiology service is or by when
the report is requested. On a particular day, the radiology
department may have received many concurrent requests
for reports, making it difficult for the department to fill
one specific request. Or the report may have been requested
between midnight and 6:00 am when fewer radiology
technologists are on duty. Variation in the process of
providing radiology reports is inherent, resulting from
common causes such as staffing levels and emergency
department census.
active failures
A process that varies only because of common causes is said
to be stable. The level of performance of a stable process
or the range of the common-cause variation in the process
can only change by redesigning the process and system.
Common-cause variation is systemic and endogenous
(that is, produced from within). The organization needs to
determine whether the amount of common-cause variation
will be tolerated. If the variation can be accommodated, a
system may be able to reach zero harm.
latent conditions
Active failures, shown as the “tip of the iceberg,”
reveal only the proximate causes of a sentinel
event; latent conditions loom below the waterline,
representing the underlying causes.
Special Cause Variation
Special-cause variation arises from unusual circumstances or
events that may be difficult to anticipate and may result in
marked variation and an unstable, intermittent, and unpredictable process. Special-cause variation is not inherently
present in systems. It is exogenous (that is, produced from
the outside), resulting from factors that are not part of the
system as designed. Mechanical malfunctions, fatigued
employees, and natural disasters such as floods, hurricanes, and earthquakes are examples of special causes that
result in variation. Organizations should strive to identify,
mitigate, and/or eliminate special causes wherever possible.
However, removing a special cause eliminates only that
current abnormal performance in the process. It does not
prevent the same special cause from recurring. For example,
firing an overly fatigued employee who was involved in a
medication error does little to prevent the recurrence of the
same error. Instead, organizations should investigate, understand, and address underlying common causes within their
systems and processes such as shift length, work schedules,
or potentially negative impact on the patient. The criterion
for a sentinel event is generally death, permanent harm, or
severe temporary harm to the patient.
Process Variations
Adverse or sentinel events involve a variation in a process.
When this variation occurs, the probability of a serious
adverse outcome increases. As mentioned previously, RCA
is a process for identifying the basic or causal factor(s)
underlying variation in performance. Variation is a change
in form, position, state, or qualities. Although a sentinel
event is the result of a variation in a process, variation is
inherent in every process. To reduce variation, it is necessary to determine its cause. What’s more, variation can be
classified by its cause.
8
CHAPTER 1
task design, employee education, complacency, information
management, and communication.
| Root Cause Analysis: An Overview
medication procurement process, communication problems, or any number of system issues that set people up to
make a mistake.
Special causes in one process are usually the result of
common causes in a larger system of which the process is
a part. For example, mechanical breakdown of a piece of
equipment used during surgery may indicate a problem
with an organization’s preventive maintenance activities.
Most root causes alone are not sufficient to cause a failure;
rather, the combination of root cause(s) and other contributing factors sets the stage. For example, flaws in the process
for communicating changes in the condition of a patient, a
poorly designed emergency call system, and an inadequate
assessment process can all be root causes of a patient’s fall
from bed. Organizations that are successful in effectively
identifying all the root causes and their interactions can
eliminate a plethora of risks when redesigning processes.5
Elimination of one root cause reduces the likelihood of that
one specific adverse outcome occurring again. However, if
the organization misses two or three other root causes, it
is possible that they could interact to cause a different but
equally adverse outcome.
Understand the Relationships Between
Common and Special Causes
Health care organizations need to delineate and evaluate all
the clinical and organizational processes and subprocesses
associated with an event under review to identify the degree
of common-cause and/or special-cause variation. This
process will help organizations identify whether variation is
due to clinical processes or organizational processes or both.
Any variation in performance, including a sentinel event,
may be the result of a common cause, a special cause, or
both. In the case of a sentinel event, the direct or proximate
special cause could be uncontrollable factors. For example,
a patient death results from a hospital’s total loss of electrical power during a storm. This adverse outcome is clearly
the result of a special cause in the operating room that is
uncontrollable by the operating room staff. Staff members
may be able to do little to prevent a future power outage
and more deaths. However, the power outage and resulting
death can also be viewed as the result of a common cause in
the organization’s system for preparing for and responding
to a utility failure and other emergencies. Perhaps the
backup generator that failed was located in the basement,
which flooded during the storm, and the organization had
no contingency plan for such a situation.
TIP
Organizations must steer clear of the “myth of one
root cause” and expect to find several possibilities.
Benefits of Root Cause Analysis
All health care organizations experience problems of varying
persistence and magnitude. Organizations can improve the
efficiency and effectiveness of their operations and the
quality and safety of care through addressing the roots of
such problems. Individual accountability for faulty performance should not be the focus of a root cause analysis. (See
Chapter 3 for additional discussion of individual accountability.) If a question arises regarding whether an individual
acted appropriately, it should be addressed through the
organization’s employee or physician performance management system. For the purpose of an RCA, the focus should
be on systems—how to improve systems to prevent the
occurrence of sentinel events or problems. This approach
involves digging into the organization’s systems to find new
ways to do things. Root cause analysis helps organizations
identify risk or weak points in processes, underlying
or systemic causes, and corrective actions. Moreover,
information from RCAs shared between and among
organizations can help prevent future sentinel events.
Knowledge shared in the health care field can contribute
to proactive improvement efforts and yield results across
the health care delivery system.
When looking at the chain of causation, proximate or
direct causes tend to be nearest to the origin of the event.
For example, proximate causes of a medication error may
include an outdated drug, product mislabeling or misidentification, or an improper administration technique. By
contrast, root causes are systemic and appear far from the
origin of the event, often at the foundation of the processes
involved in the event. For example, root causes of a medication error might include manufacturer’s production or
labeling of two different types or strengths of drugs so
that one looks too much like the other. Root causes might
also include storage setup that places different dosages of
the same medication too close together, an inadequate
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Maximizing the Value of Root Cause Analysis
The outcome of the root cause analysis is a strong corrective
action plan implemented by the organization to reduce the
risk of similar events occurring and increase the likelihood
of positive outcomes in the future. The plan should address
responsibility for implementation, oversight, pilot testing
as appropriate, time lines, and strategies for measuring the
effectiveness and sustainability of actions.
Root cause analysis is designed to answer the following
three questions:
1. What happened?
2. Why did it happen?
3. What can be done to prevent it from happening again?
The Need for Follow Up
The problem, however, is that health care organizations
frequently use root cause analysis to answer these questions
but never determine whether the risk of recurrence of an
adverse event has actually been reduced. Therefore, some
health care organizations may dedicate resources to root
cause analysis without knowing whether the investment has
any payoff. To make root cause analysis more useful, organizations should utilize follow-up activities that measure
the implementation of process changes and improvements
in patient outcomes. Follow-up activities should become a
standardized component of the process.6
The Root Cause Analysis and Corrective
Action Plan: Doing It Right
Improvement Challenges
Developing a Causal Statement
To ensure that the RCA yields improvement, health care
leaders must address fundamental challenges that can
limit the value of the incident investigation. The literature has highlighted potential challenges and opportunities for improvement with RCA in health care including
the following7:
Being able to focus in on root causes and succinctly define
them sets the foundation for the remainder of the RCA.
The Joint Commission identifies patterns for risk-reduction activities by reviewing root cause analyses of sentinel
events. This information may benefit organizations developing their own corrective action plans. Organizations will
need to establish guidelines when identifying and documenting specific systems flaws that lead to sentinel events.
Table 1-1, page 14, provides organizations with the “five
rules of causation,” as defined in RCA2, along with samples
of incorrect and correct ways to capture root causes in their
documented analyses.
How can an organization ensure that its RCA and corrective action plan represent an appropriate response to a
particular sentinel event? The Joint Commission and
JCI provide guidance to organizations conducting RCAs
in their respective sentinel event policies. These policies
provide criteria that organizations can use to evaluate their
RCA for strength of action, acceptability, thoroughness, and
credibility. Organizations can use the tool in Figure 1-3,
pages 12–13, to review their RCAs based on these criteria.
• Improving how we measure the impact of improvements
made following an RCA with reducing the risk of
future events
• Redesigning the process and the tools used to conduct
an RCA
• Increasing the level of involvement from
organization leadership
• Focusing on stronger corrective actions
• Measuring implementation and impact of corrective
actions on outcomes
• Making room for an abbreviated incident review
when appropriate
Crafting an Acceptable Corrective
Action Plan
The Joint Commission and JCI also provide criteria for
an acceptable corrective action plan within their sentinel
event policies. According to the Joint Commission policy,
a corrective action plan will be considered acceptable if it
does the following:
• Identifies changes that can be implemented to reduce
risk or formulates a rationale for not undertaking such
changes
• Identifies, in situations in which improvement actions
are planned, the following:
The Joint Commission takes this and other feedback and
data into consideration as it continuously adjusts and
improves the way it works with health care organizations
to maximize their response to sentinel events, and it is
reflected in this book on root cause analysis. Consider the
strategies listed in Sidebar 1-4, page 11.
10
CHAPTER 1
| Root Cause Analysis: An Overview
Sidebar 1-4. Strategies for an Effective RCA
►► Repeatedly ask “Why?” Until the analysis identifies
help investigators pinpoint where the root cause of
an event lies they also can provide investigators with
a starting point for improvement planning by allowing
them to track performance before and after changes to
systems and processes occur.
the systemic causal factors associated with each step
in the sequence that led to the sentinel event, keep
asking why. Break down work processes to understand
systemic and process-related causes. Then, follow the
causal chain upstream to find the causative factors and
root cause of the event.
►► Inquire into all areas appropriate to the specific
type of event. The root cause analysis team should
consider where else in the organization or facility the
underlying conditions that led to the incident prevail.
When an effective corrective action is identified, it can
then be applied on an organizationwide basis.
►► Focus the analysis on systems and processes,
not solely on individual performance. Because
root cause analysis is a process focused on finding
out why an adverse event occurred, as opposed to
assigning blame or responsibility for it, keep your focus
on systems and processes, rather than on individual
performance. This focus not only lends clarity to the
work, it also encourages staff to take part in an honest
analysis of the causes of adverse events, which in
turn leads to better results and a reinforcement of the
culture of safety.
►► Identify risk points and their potential contributions
to this type of event. Here again a careful analysis of
processes and systems will help investigators identify
which parts of tasks or processes carry inherent risk
for events such as the one under investigation.
►► Determine potential improvements in processes or
systems that would tend to decrease the likelihood
of such events in the future, or determine, after
analysis, that no such improvement opportunities
exist. Armed with the information gained through the
root cause analysis process, the team should create
a corrective action plan that explains how the organization can decrease the likelihood of a recurrence.
The plan should be specific and include methods for
monitoring implementation, compliance, and maintenance. Data analysis and change management tools
in Chapter 7 can help the team adopt improvements,
monitor whether those changes are being implemented
and having the desired effects, and follow through to
make sure the changes stick.
►► Determine the human and other factors most
directly associated with the sentinel event and the
process(es) and systems related to its occurrence.
Investigators and staff involved in the incident may
have a variety of ideas as to what caused the event,
and investigators should consider each of these ideas.
Using the data collection and analysis tools in this
book, the root cause analysis team can determine
which of the possible causes contributed to the
event. This data-driven approach yields credible,
actionable information.
►► Use the analysis to help determine where redesign
might reduce risk. Data analysis tools can not only
Source: Adapted from The Joint Commission, 2017 Comprehensive Accreditation Manual for Hospitals, Oak Brook, 2017.
TIP
–– Who is responsible for implementation
–– When the action will be implemented (including any
pilot testing)
–– How the effectiveness of the actions will be evaluated
–– The point at which alternative actions will be
considered if improvement targets are not met
An organization can seek clarification of any
questions about The Joint Commission’s
Sentinel Event Policy and the requirements for
a comprehensive systematic analysis by visiting
http://www.jointcommission.org/sentinel_event
_policy_and_procedures/. Note that The Joint
Commission will not give a determination of
reviewability at this point but can answer questions
and provide support (see also the Appendix for
related information).
Table 1-2, page 15, highlights sample questions that might
be used when investigating a medication error, one of the
top reviewed sentinel events by The Joint Commission.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 1-3. Root Cause Analysis Evaluation Checklist
Acceptability
DOWNLOAD
Y
N
N/A
Follow-Up Action
Required?
Follow-Up Action
Completed (Date)
Y
N
N/A
Follow-Up Action
Required?
Follow-Up Action
Completed (Date)
Identifies and implements actions to eliminate or
control systems hazards or vulnerabilities.
Identifies, in situations in which improvement
actions are planned, who is responsible
for implementation, when the action will be
implemented, how the effectiveness of the
actions will be evaluated, and how the actions
will be sustained.
Identifies at least one stronger or intermediate
strength action for each comprehensive
systematic analysis.
Thoroughness
Repeatedly asks a series of “Why?” questions,
until it identifies the systemic causal factors
associated with each step in the sequence that
led to a sentinel event.
Focuses on systems and processes, not solely on
individual performance.
Determines the factors most directly associated
with the sentinel event and the processes and
systems related to its occurrence, including
human factors
Analyzes the underlying systems and processes
through a series of “Why?” questions to
determine where redesign might reduce risk.
Inquires into all areas appropriate to the specific
type of event.
Identifies the risk points and their potential
contributions to this type of event.
Determines potential improvement in processes
or systems that would tend to decrease the
likelihood of such events in the future or a
determination, after analysis, that no such
improvement opportunities exist.
12
CHAPTER 1
| Root Cause Analysis: An Overview
Figure 1-3. Root Cause Analysis Evaluation Checklist continued
Credibility
Y
N
Follow-Up Action
Required?
N/A
Follow-Up Action
Completed (Date)
Includes patients, family, or patient
representatives when appropriate to ensure a
thorough understanding of the facts.
Includes participation by the patient safety
director and by individuals most closely involved
in the processes and systems under review.
Is internally consistent (that is, the analysis does
not contradict itself or leave obvious questions
unanswered).
Provides an explanation for all findings of “not
applicable” or “no problem.”
Considers all relevant literature, guidelines, or
evidence-based best practices.
This checklist includes criteria to help a root cause analysis team assess the quality of their root cause analysis. You can
use it to evaluate whether the analysis is acceptable, thorough, and credible. Answers to all questions should ideally be
Y for Yes (unless they aren’t applicable).
Sidebar 1-5, page 16, outlines the high-level key tasks or
steps involved in performing a thorough and credible root
cause analysis and corrective action plan. (These 21 steps
are explored in Chapters 3 to 6.) Overall, a thorough and
credible root cause analysis should do the following:
• Be clear (understandable information)
• Be accurate (validated information and data)
• Be precise (objective information and data)
• Be relevant (focus on issues related or potentially related
to the sentinel event)
• Be complete (cover all causes and potential causes)
• Be systematic (methodically conducted)
• Possess depth (ask and answer all of the relevant “Why”
questions)
• Possess breadth of scope (cover all possible systemic
factors wherever they occur)
TIP
Use a WWW (What, Who, When): The WWW is
an action planning tool that captures the tasks
that need to be completed, who is responsible,
and when they can get it done. Teams can use a
WWW to keep track of next steps that come out of
team meetings, and/or as an ongoing document.
The tool consists of a simple grid, such as in the
example below. The first column lists the individual
responsible for the action, the second lists the
action itself, and the third indicates a due date.
Columns can be added to track status or capture
notes if necessary. (A WWW template is available
in the e-book DOWNLOAD or on the flash drive.)
WHO
The Joint Commission’s framework for a root cause analysis
and corrective action plan appears as the Appendix. This
framework, referenced in Chapters 3 through 6, provides
a solid foundation for root cause analyses and corrective
action plans. The tool selection matrix, found in Chapter 7
as Table 7-1, page 112, can also be used as a guide to ensure
that an organization considers and selects the most appropriate tools and techniques for root cause analysis. Also,
team leaders can assess the quality of the analysis using an
WHAT
WHEN
evaluation tool such as the Root Cause Analysis Evaluation
Checklist (see Figure 1-3, above).
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Table 1-1. Five Rules of Causation1: Correcting System Issues
Incorrect
Rule
Correct
A resident was fatigued.
Clearly show the cause-and-effect
relationship.
An overworked resident’s fatigue led to
misreading medication dosing orders and
could result in patient overdose.
The pump user’s instructions are not
written well.
Use specific and accurate descriptors
for what occurred, rather than negative
and vague words.
The manual’s close spacing and lack of
graphics led to little use and could result
in incorrect use of a pump.
The resident used a wrong dosage,
resulting in a patient’s overdose.
Human errors must have a preceding
cause.
The computer system’s drug dosage
program leaves little space between
dosage options and could result in a
resident selecting an incorrect dose.
Technicians did not follow proper CT scan
procedures and patient suffered a fatal air
embolism.
Violations of procedure are not root
causes, but must have a preceding
cause.
Area distractions such as noise and
mismanagement led to a skipped step in a
CT-scan procedure and a technician’s use
of an empty syringe injection that resulted
in a patient’s air embolism.
The nurse failed to check STAT orders
in a timely way, resulting in delayed
anticoagulation therapy and a potential
blood clot.
Failure to act is only causal when there
is a pre-existing duty to act.
An incomplete assignment list and
confusion about RN responsibilities could
result in an RN missing a STAT order and
delaying critical patient therapy.
Reference:
1. The Federal Aviation Administration technical report “Maintenance Error Causation.” David A. Marx, Jun 1999.
Source: Adapted from National Patient Safety Foundation. RCA2 Improving Root Cause Analysis and Actions to Prevent Harm. 2015. www.npsf.org.
14
CHAPTER 1
| Root Cause Analysis: An Overview
Table 1-2. Sample Questions to Ask When Reviewing a Medication Error
Potential Root Cause
Sample Questions
Patient Identification Process
Are specific patient identification processes and protocols in place?
Did the providers, clinicians, and staff verify the patient’s identity?
Was the patient identified by a bar-coded wristband or any other means?
Staffing Levels
What are the typical staffing levels on the unit?
How many staff members were working on the unit where the error occurred?
How many patients were assigned to the nurse who was involved in the error?
Orientation and Training of Staff
Does the organization offer medication safety training?
Did the nurse involved in the error participate in medication safety training?
Competency Assessment/Training
Are nurses at the organization required to demonstrate competency in
medication administration?
Did the nurse who was involved in the error demonstrate medication
administration competency?
Supervision of Staff
Who was supervising the nurse who was involved in the error?
How many other nurses was the supervisor responsible for?
Does the supervisor specifically oversee the medication administration process?
Communication Among Staff Members
Are there established processes and protocols in place for nurses to
communicate with physicians and pharmacists about medication orders?
Did all staff members involved properly follow the communication protocols?
Availability of Information
Does the organization routinely supply information about medications?
Did the staff members involved review all information available to them?
Adequacy of Technological Support
Are there any technologies in place to support the medication administration
process?
If “yes,” were these technologies properly used?
If “no,” are there technologies available that would enhance the medication
administration process?
Equipment Maintenance/Management
Were all medication distribution systems (for example, medication cabinets) in
working order?
How often are these systems maintained?
Physical Environment
Did any environmental factors make it difficult for the nurse to properly carry out
medication administration duties?
What environmental factors (for example, lighting, space considerations)
would make it easier for staff members to properly carry out the medication
administration process?
Control of Medications: Storage/Access
Were the medications in question stored in the accepted manner?
Were the medications accessed in the accepted manner?
Labeling of Medications
Were the medications in question properly labeled?
What processes or protocols are in place to verify that the label matched
the medication?
Are there any protocols in place to ensure that “look-alike” prescriptions are
properly identified on the label?
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
References
Sidebar 1-5.
Steps in Conducting a Root
Cause Analysis and Implementing
a Corrective Action Plan
1.
Organize a team
2.
Define the problem
3.
Study the problem
4.
Determine what happened
5.
Identify contributing process factors
6.
Identify other contributing factors
7.
Measure—collect and assess data on proximate
and underlying causes
8.
Design and implement immediate changes
9.
Identify which systems are involved—the
root causes
1. Reason J. Human error: Models and management. BMJ. 2000
Mar 18;320(7237):768–770.
2. Croteau RJ, Schyve PM. Proactively error-proofing health care
processes. In Spath PL, editor: Error Reduction in Health Care:
A Systems Approach to Improving Patient Safety. San Francisco:
Jossey-Bass, 2000, 179–198.
3. The Joint Commission: Failure Mode and Effects Analysis in
Health Care: Proactive Risk Reduction, 3rd ed. Oak Brook, IL:
Joint Commission Resources, 2010.
4. Department of Veterans Affairs, Veterans Health Administration,
VHA Patient Safety Improvement Handbook 1050.01,
May 23, 2008.
5. Knudsen P, et al. Preventing medication errors in community
pharmacy: Root-cause analysis of transcription errors. Qual Saf
Health Care. 2007 Aug;16(4):285–290.
6. Wu AW, Lipshutz AK, Pronovost PJ. Effectiveness and
efficiency of root cause analysis in medicine. JAMA. 2008 Feb
13;299(6):685–687.
10. Prune the list of root causes
11. Confirm root causes and consider their
interrelationships
7. AHRQ Patient Safety Network: Gupta K, Lyndon A. Annual
Perspective: Rethinking Root Cause Analysis. AHRQ Patient
Safety Network. Available at: https://psnet.ahrq.gov/perspectives
/perspective/216. Jan 2017.
12. Explore and identify risk-reduction strategies
13. Formulate improvement actions
14. Evaluate proposed improvement actions
15. Design improvements
16. Ensure acceptability of the action plan
17. Implement the improvement plan
18. Develop measures of effectiveness and ensure
their success
19. Evaluate Implementation of Improvement efforts
20. Take additional action
21. Communicate the results
16
CHAPTER
2
Addressing Sentinel Events in
Policy and Strategy
• What issues should be considered as an organization
develops its own sentinel event policy?
• How should an organization respond after a
sentinel event?
• Who must be notified after a sentinel event occurs?
• What are the legal and ethical considerations of
disclosure to patients?
Learning Objectives
• Become familiar with The Joint Commission’s
Sentinel Events Policy and that of Joint
Commission International
• Understand the differences among types of
patient safety events
• Learn how to develop a sentinel event policy for
the organization
Although the answers to these questions tend to be organization-specific, some general guidelines can be useful. This
chapter provides such guidelines, but organizations should
consult additional sources of information as needed.
• Explore the components and value of leadership
and a culture of safety in reducing variation
in performance and the occurrence of patient
safety events
The Range of Adverse Events in Health Care
• Learn the importance of keeping medical record
documentation of errors or sentinel events for
continuity of care
The Joint Commission’s Sentinel Event Policy is designed
to improve patient safety in all health care organizations
by working with and learning from organizations that
experience serious adverse events in patient care. The
policy encourages the self-reporting of sentinel events to
The Joint Commission that enables it to learn about the
relative frequencies and underlying cause(s) of sentinel
events and to share “lessons learned” with other health care
organizations. This transparency helps reduce the risk of
future sentinel events in other organizations. Organizations
outside the United States accredited by JCI are guided by
a similar Sentinel Event Policy. A comparison of the Joint
Commission and JCI policies appears later in this chapter.
The Joint Commission defines sentinel event as a patient
safety event (not primarily related to the natural course of
the patient’s illness or underlying condition) that reaches
a patient and results in any of the following:
Root cause analysis (RCA) plays a key role in the iden­
tification and prevention of sentinel events. A number
of questions arise in considering sentinel events, such as
the following:
• What is a sentinel event and how does it differ from
other events, incidents, or occurrences that take place
routinely in health care organizations?
• What role does an organization’s culture play in the
identification and prevention of adverse events?
• What do The Joint Commission and Joint Commission
International (JCI) require when a sentinel event occurs?
• What types of events require comprehensive systematic
analysis, such as an RCA?
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
• Death
• Permanent harm
• Severe temporary harm*
Sidebar 2-1.
Classification of Patient Safety Events
►► Patient safety event: an event, incident, or condi-
Responding to a Sentinel Event
tion that could have resulted or did result in harm to
a patient
Sentinel events signal a need for immediate investigation
and response. All sentinel events must be reviewed by
the organization and are subject to review by The Joint
Commission. Accredited organizations are expected to
identify and respond appropriately to all sentinel events
(as defined by The Joint Commission) occurring in the
organization or associated with services that the organization provides. An appropriate response includes all of
the following:
• A formalized team response that stabilizes the patient,
discloses the event to the patient and family, and
provides support for the family as well as staff involved
in the event
• Notification of organization leadership
• Immediate investigation
• Completion of a comprehensive systematic analysis for
identifying the causal and contributing factors
• Strong corrective actions derived from the identified
causal and contributing factors that eliminate or control
system hazards or vulnerabilities and result in sustainable
improvement over time
• Time line for implementation of corrective actions
• Systemic improvement
• Ongoing measurement and assessment that corrective
actions had the desired and maintained effect on
the process
►► Adverse event: a patient safety event that resulted
in harm to a patient
►► Sentinel event: a patient safety event (not primarily
related to the natural course of the patient’s illness
or underlying condition) that reaches a patient
and results in death, permanent harm, or severe
temporary harm
►► No-harm event: a patient safety event that reaches
the patient but does not cause harm
►► Close call*: a patient safety event that did not reach
the patient
►► Hazardous (or “unsafe”) condition: a circumstance
(other than a patient’s own disease process or
condition) that increases the probability of an
adverse event
* Also referred to as a near miss. Close call is the preferred term.
of a defective system or process design, a system breakdown,
equipment failure, or human error.
Signals of Risk: Close Calls and
No-Harm Events
Fortunately, the majority of patient safety events cause no
harm. For example, missed medication dosages or dosages
administered at the wrong time rarely result in death or
serious permanent or temporary harm. However, these
events may signal the presence of a much larger problem.
Organizations should integrate information about such
events as part of their ongoing data collection and analysis.
Sentinel events are one type of patient safety event, which
is an event, incident, or condition that could have resulted
or did result in harm to a patient. Patient safety events also
include adverse events, no-harm events, close calls, and
hazardous conditions. (See Sidebar 2-1 for definitions.) A
patient safety event can be, but is not necessarily, the result
A close call does not result in serious harm, but easily could
have. For example, suppose a nurse was about to administer medication to a patient via the incorrect route, such
as intravenously rather than orally, when she notices the
discrepancy in the order and holds off on giving the patient
the medication so that the issue can be resolved. The patient
could have suffered harm if the nurse hadn’t caught the
discrepancy and perhaps would even be expected to suffer
harm with a similar error.
* Severe temporary harm is critical, potentially life-threatening harm
lasting for a limited time with no permanent residual, but requires
transfer to a higher level of care/monitoring for a prolonged period of
time, transfer to a higher level of care for a life-threatening condition,
or additional major surgery, procedure, or treatment to resolve the
condition. Adapted from Healthcare Performance Improvement, LLC.
The HPI SEC & SSER Patient Safety Measurement System for Healthcare,
rev. 2. Throop C, Stockmeier C. May 2011. Accessed May 12, 2017.
http://www.pressganey.com/docs/default-source/default-document
-library/hpi-white-paper---sec-amp-sser-measurement-system-rev-2
-may-2011.pdf .
18
CHAPTER 2
Responding to Patient Safety Events
| Addressing Sentinel Events in Policy and Strategy
Sidebar 2-2.
Understanding Error
The Joint Commission does not require health care organizations to conduct a comprehensive systematic analysis for
a close call. However, using a root cause analysis or other
investigation methodology to identify the contributing
factors to a close call can help organizations address any
risk points that could lead to patient harm down the road.
This is one example of how RCA can be used proactively to
prevent system failures or process variations from reaching
your patients.
Though not all sentinel events result from errors, many
do. These can include both errors of commission or
errors of omission.
An error of commission occurs as a result of an action
taken—for example, when surgery is performed on
the wrong limb, when a medication is administered
by an incorrect route, when an infant is discharged to
the wrong family, or when a transfusion error occurs
involving blood crossmatched for another patient.
The health care organization determines how it will respond
to patient safety events that do not meet the definition of
a sentinel event. For example, adverse events (which may
or may not result from an error) should result in prompt
notification of organization leaders, investigation, and
corrective actions, according to the organization’s process
for responding to patient safety events that do not meet the
definition of a sentinel event. An adverse event may or may
not result from an error. (See Sidebar 2-2 for a discussion
of error.)
An error of omission occurs as a result of an action not
taken—for example, when a delayed diagnosis results
in a patient’s death, when a medication dose ordered is
not given, when a physical therapy treatment is missed,
or when a patient suicide is associated with a lapse in
carrying out frequent observation.
Errors of commission and omission may or may not
lead to adverse outcomes. For example, suppose a
patient in seclusion is not monitored during the first
two hours. The staff corrects the situation by beginning
regular observations as specified in organization policy.
The possibility of failure is present, however, and the
mere fact that the staff does not follow organization
policy regarding seclusion, and thereby violates acceptable professional standards, signals the occurrence of a
failure requiring study to ensure that it does not happen
again. In this case, the error of omission was insufficient
monitoring. If the patient suffers serious physical or
psychological harm during seclusion, the sentinel event
is the patient’s adverse outcome.
TIP
Track no-harm events, close calls, and hazardous
conditions and use them as opportunities to learn.
(Leadership standards require the scope of the
safety program to include the full range of safety
issues, from potential or no-harm errors [sometimes
referred to as close calls or good catches] to
hazardous conditions and sentinel events.)
By definition, sentinel events require further investigation each time they occur.
Which Events Does The Joint
Commission Review?
The Joint Commission’s Sentinel
Event Policy
The Sentinel Event Policy requires organizations to conduct
a comprehensive systematic analysis, such as an RCA, if a
sentinel event occurs. Reporting the sentinel event to The
Joint Commission is voluntary, but strongly encouraged.
To best develop and implement a sentinel event policy
of their own, organizations should understand The Joint
Commission’s Sentinel Event Policy.
The policy includes a list of patient safety events considered
to be sentinel events regardless of whether they result in
death, permanent harm, or severe temporary harm (see
Sidebar 2-3, page 20). Organizations should respond to
these events the same way they would to any other
sentinel event.
The information provided here is current as of the time of
this book’s publication. The Sentinel Event Policy appears
in the “Sentinel Events” chapter of the Comprehensive
Accreditation Manual for each accreditation program.
The accreditation manuals are updated twice annually,
19
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Sidebar 2-3. Examples of Sentinel Events
All instances of the following types of patient safety
events are considered sentinel, even if the event did not
cause death or severe harm:
►► Severe maternal morbidity (not primarily related to the
natural course of the patient’s illness or underlying
condition) when it reaches a patient and results in
permanent harm or severe temporary harm║
►► Suicide of any patient receiving care, treatment, and
* Sexual abuse/assault (including rape) as a sentinel event is defined as
nonconsensual sexual contact involving a patient and another patient, staff
member, or other perpetrator while being treated or on the premises of
the hospital, including oral, vaginal, or anal penetration or fondling of the
patient’s sex organ(s) by another individual’s hand, sex organ, or object.
One or more of the following must be present to determine that it is a
sentinel event:
• Any staff-witnessed sexual contact as described above
• Admission by the perpetrator that sexual contact, as described above,
occurred on the premises
• Sufficient clinical evidence obtained by the hospital to support allegations
of unconsented sexual contact
services in a staffed around-the-clock care setting or
within 72 hours of discharge, including from the emergency department (ED)
►► Unanticipated death of a full-term infant
►► Discharge of an infant to the wrong family
►► Abduction of any patient receiving care, treatment,
and services
►► Any elopement (that is, unauthorized departure) of a
Invasive procedures, including surgery, on the wrong patient or at the
wrong site or that is the wrong procedure are reviewable under the policy,
regardless of the type of the procedure or the magnitude of the outcome.
†
patient from a staffed around-the-clock care setting
(including the ED), leading to death, permanent harm,
or severe temporary harm to the patient
After surgery is defined as any time after the completion of final skin
closure, even if the patient is still in the procedural area or in the operating
room under anesthesia. This definition is based on the premise that a
failure to identify and correct an unintended retention of a foreign object
prior to that point in the procedure represents a system failure, which
requires analysis and redesign. It also places the patient at additional risk
by extending the surgical procedure and time under anesthesia. If a foreign
object (for example, a needle tip or screw) is left in the patient because of
a clinical determination that the relative risk to the patient of searching for
and removing the object exceeds the benefit of removal, this would not
be considered a sentinel event to be reviewed. However, in such cases,
the organization shall (1) disclose to the patient the unintended retention,
and (2) keep a record of the retentions to identify trends and patterns (for
example, by type of procedure, by type of retained item, by manufacturer,
by practitioner) that may identify opportunities for improvement.
‡
►► Hemolytic transfusion reaction involving administration
of blood or blood products having major blood group
incompatibilities (ABO, Rh, other blood groups)
►► Rape, assault (leading to death, permanent harm, or
severe temporary harm), or homicide of any patient
receiving care, treatment, or services while on site at
the organization*
►► Rape, assault (leading to death, permanent harm,
or severe temporary harm), or homicide of a staff
member, licensed independent practitioner, visitor, or
vendor while on site at the organization
Fire is defined as a rapid oxidation process, which is a chemical reaction
resulting in the evolution of light and heat in varying intensities. A combustion process that results in smoldering condition (no flame) is still classified
as fire. Source: National Fire Protection Association. NFPA 901: Standard
Classifications for Incident Reporting and Fire Protection Data. Quincy, MA:
NFPA, 2015.
§
►► Invasive procedure, including surgery, on the wrong
patient, at the wrong site, or that is the wrong (unintended) procedure†
 Severe maternal morbidity is defined, by the American College of
Obstetrics and Gynecology, the US Centers for Disease Control and
Prevention, and the Society of Maternal-Fetal Medicine, as a patient safety
event that occurs from the intrapartum through the immediate postpartum
period (24 hours), requiring the transfusion of four or more units of packed
red blood cells (PRBC) and/or admission to the intensive care unit (ICU).
Admission to the ICU is defined as admission to a unit that provides
24-hour medical supervision and is able to provide mechanical ventilation
or continuous vasoactive drug support. Ongoing vigilance to better identify
patients at risk—and timely implementation of clinical interventions consistent with evidence-based guidelines—are important steps in the ongoing
provision of safe and reliable care. Appropriate systems improvements can
be informed by identifying occurrences of maternal morbidity, reviewing
the cases, and analyzing the findings. For additional details, see “Update:
Revised Definition of Severe Maternal Morbidity in Sentinel Event Policy,”
June 2015 Perspectives.
►► Unintended retention of a foreign object in a patient
after an invasive procedure, including surgery‡
►► Severe neonatal hyperbilirubinemia (bilirubin > 30
milligrams/deciliter)
►► Prolonged fluoroscopy with cumulative dose > 1,500
rads to a single field or any delivery of radiotherapy to
the wrong body region or > 25% above the planned
radiotherapy dose
►► Fire, flame, or unanticipated smoke, heat, or flashes
occurring during an episode of patient care§
►► Any intrapartum (related to the birth process)
maternal death
20
CHAPTER 2
which may include updates to the Sentinel Event Policy.
Changes to policy are reported in The Joint Commission
Perspectives®, which is accessible via your organization’s
Joint Commission Connect™ extranet site. For more information about The Joint Commission’s Sentinel Event Policy,
visit The Joint Commission’s website at http://www
.jointcommission.org or call the Office of Quality and
Patient Safety at 630-792-3700.
| Addressing Sentinel Events in Policy and Strategy
TIP
For more than 60 years, The Joint Commission
has been a champion of patient safety by helping
health care organizations to improve the quality
and safety of the care they provide. Call the Joint
Commission’s Office of Quality and Patient Safety*
at 630-792-3700 for help with any of the following:
►►Collaborative discussion and general
interpretation of any aspect of the Sentinel
Event Policy
Goals of the Sentinel Event Policy
1. To have a positive impact in improving patient
care, treatment, and services and in preventing
unintended harm
2. To focus the attention of an organization that has
experienced a sentinel event on understanding the
factors that contributed to the event (such as underlying
causes, latent conditions, and active failures in defense
systems or organization culture), and on changing the
organization’s culture, systems, and processes to reduce
the probability of such an event in the future
3. To increase the general knowledge about patient
safety events, their contributing factors, and strategies
for prevention
4. To maintain the confidence of the public, clinicians, and
health care organizations and keep patient safety as a
priority in accredited organizations
►►Collaborative education/guidance regarding the
comprehensive systematic analysis process, of
which the root cause analysis process is the most
frequently used
►►Collaborative education/guidance regarding
the identification of causal factors/root causes,
and the development of strong risk-reduction
strategies and corrective action plans
* The Joint Commission Office of Quality and Patient Safety was
formerly known as The Office of Quality Monitoring.
Reasons for Reporting a Sentinel Event to
The Joint Commission
When an organization reports a sentinel event, The Joint
Commission or JCI is able to help it through the response
process. Self-reporting a sentinel event gives organizations
the opportunity to work with someone who may have
more exposure to and more experience in addressing similar
issues. Joint Commission patient safety specialists work
with a wide spectrum of health care organizations on a
regular basis to address many types of sentinel events. They
lend valuable support to any and every organization that
experiences a sentinel event (see Figure 2-2, page 23, for
more on reporting sentinel events).
How The Joint Commission Becomes Aware
of a Sentinel Event
Each accredited US health care organization is encouraged,
but not required, to report to The Joint Commission any
patient safety event that meets The Joint Commission’s
definition of a sentinel event. Likewise, health care organizations outside of the United States are encouraged to
report sentinel events to JCI.
Alternatively, the accreditor may become aware of a sentinel
event by some other means, such as communication from
a patient, family member, or employee of the organization or via media reports. Sentinel event inquiries may be
directed anonymously to the Office of Quality and Patient
Safety. Reports of possible sentinel events set in motion
The Joint Commission’s sentinel event process, as shown
in Figure 2-1, page 22.
Any organization that experiences a sentinel event can
benefit from this review process. In particular, organizations for which such events are very rare may see the most
benefit. In these organizations, the staff may be experiencing a particular event for the first time or for the first
time in several years (see Table 2-1, page 24, for types of
sentinel events that are reviewed). The Joint Commission
staff is a valuable collaborative resource due to their cumulative knowledge of sentinel events gleaned from working
with many other organizations on similar incidents.
21
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 2-1. Sentinel Event Process Flow*
New sentinel event is reported to The Joint Commission (via voluntary self-report, complaint, referral
from survey, media report, federal or state agencies, and other regulatory bodies).
Patient safety specialist in the Office of Quality and Patient Safety creates an electronic case (incident).
Patient safety specialist contacts the organization to obtain additional details and determine
if safety event meets the sentinel event definition.
No
Yes
Event is reviewed as a patient safety event
requiring analysis (proactive risk assessment) for unsafe or hazardous conditions and
submission of an organization response.
Does the event meet the
criteria for a sentinel event?
Organization selects alternative type for sharing of
a comprehensive systematic analysis within 5 business days and the submission due date is confirmed.
Organization provides the comprehensive systematic
analysis (e.g., RCA) and corrective action plan
information within 45 business days of having
become aware of the event and confirming with the
Office of Quality and Patient Safety, via the selected
alternative type.
Patient safety specialist conducts a scheduled feedback review with the organization to
review analysis findings, root causes/causal factors, and the related corrective action plan.*
No
Yes
Does the plan identify and implement actions to eliminate
or control systems hazards or vulnerabilities?
Organization
revises its plan with
help from patient
safety specialist
as a second set
of eyes sharing
lessons learned.
Does the plan identify, in situations in which improvement actions are planned, who
is responsible for implementation, when the action will be implemented, how the
effectiveness of the actions will be evaluated, and how the actions will be sustained?
Using data
collection the
organization
sustains and
monitors
improvements.
Does the plan identify at least one stronger or intermediate strength action?
* Please refer to the Sentinel Event Policy in the Sentinel Event (SE) Chapter in your Comprehensive Accreditation
Manual for the most up-to-date criteria organizations use to develop root cause analyses and address vulnerabilities
with corrective action plans.
The rewards of reporting sentinel events extend beyond
the organization itself. Reporting sends a message to the
public that the organization is doing all it can to prevent
recurrence of a sentinel event (see Figure 2-3, page 23, for
percentages of self-reported events).
to the reduction of risk for such events in many other
organizations (see Sidebar 2-4, page 25, for a discussion of
government reporting requirements).
How to Report a Sentinel Event
Reporting a sentinel event can be done online with a form
accessible on an organization’s secure and encrypted Joint
Commission Connect™ extranet site. Once logged in, place
the cursor over “Continuous Compliance Tools.” A dropdown list will appear. From this list, select “Self-Report
Further, reporting the event enables the addition of the
“lessons learned” from the event to be added to The Joint
Commission’s Sentinel Event Database, thereby contributing to the general knowledge about sentinel events and
22
17
0
2005
2006
Summary Data of Sentinel Events Reviewed by The Joint Comm
17
2007
2008
2009
Self Reported
2010
Other
2011
2012
Media
12
2013
2014
2015
2016
Total
| The
CHAPTER
2 to
Addressing
Events in is
Policy
and Strategy
Data Limitations: The reporting of most sentinel
events
JointSentinel
Commission
voluntary
and represen
of actual events. Therefore, these data are not an epidemiologic data set and no conclusions should be dra
Sentinel Event O
relative frequency of events or trends2014
in events over
time.
2015
2016
2005 to 2016
Percent Self Reported
through
Type of Sentinel Event
Anesthesia-Related
6The Joint Commission,
7
4
Patient death
Figure
2-2.Event
Sentinel
2005
to 2016108
Total
number
of
SentinelEvents
EventsReported
reviewed by
by47The
Joint Commission
1995
Criminal
Event
47
32 through 2016
442
Permanent harm
Delay In Treatment
79
83
54
1068
Permanent loss of fu
Dialysis-Related Event
2
0
7
19
Severe temporary ha
Reported Sentinel Events by Year by Source, 2005 to 2016
Elopement
6
7
9
103
Psychological impact
1400
Fall
93
95
92
869
Unexpected addition
1246
Fire
10
26
15
150
Unassigned***
1200 Abduction
Infant
0
3
2
29
Unknown
Infant Discharge to Wrong Family
0
0
1
4
Other
960
1000
Infection-Related
Event
12
2 936
170
Total patients impac
900 13 887
831
824 121
Inpatient Drug Overdose
8865
13
13
807
764
748
800
Maternal
Death
11
6
7698
125
664
649
Med Equipment-Related
9
14622
10
238
624
597
577
574
Medication
Error 517
20
47
33
476
600
510
Op/Post-op Complication 447
53
82
45
920
*Other settings includ
369
358Event**
Other
73 326
58
47
632
Imaging, Hospice Care
400 Unanticipated
291
279
275
Perinatal Death/Injury
35
23
362
234 43 253
209
209
207
**Other unanticipated
165
Radiation
Overdose 142
4
4
4
200
128 46
Choked on food, Drow
Restraint Related Event
2
7
7
55
45
42
32 124
29
26
24
22
21
17
17
12
Self-Inflicted
Injury
5
21
17
100
***Category unassign
0
Severe Maternal
9
2005 Morbidity
2006
2007
2008
2009
2010 0 2011
2012 0 2013
2014 9 2015
2016
****Multiple patients
Severe Neonatal Hyperbilirubinemia
0
2
0
8
Self Reported
Other
Media
Total
Suicide
84
98
87
1013
Transfer-Related Event
2
1
2
30
The graph
above reflects
Transfusion
Error top sentinel events between 2005 and72016, the latest 9date for
5
127
which data
is publicly available.
Unassigned***
4
3
70
77
Sentinel Event O
Unintended Retention of a Foreign Body
1231
2014 116
2015 123
2016 120 2005 to 2016
through
Utility SystemType
Failure
0
1
1
9
of Sentinel Event
Ventilator Death
3
3
2
54
Anesthesia-Related Event
6
7
4
108
Patient death
Wrong–patient, wrong-site, wrong-procedure
73
120
104
1281
Criminal Event
47
47
32 2016
442
Permanent harm
Figure
2-3.
Percent
Self-Reported
of
Sentinel
Events,
2005
to
Total Incidents Reviewed
764
936
824
9945
Delay In Treatment
79
83
54
1068
Permanent loss of fu
Dialysis-Related Event
2
0
7
19
Severe temporary ha
Elopement
6
7
9
103
Psychological impact
Fall
93 Events, 200595
92
869
Unexpected addition
Percent Self-Reported of Sentinel
to 2016
Fire 90%
10
26
15
150
Unassigned***
81%
Infant Abduction
0
3
29
Unknown
76% 2 75%
80%
72%
71%
69%
69%
Infant Discharge to Wrong
Family
0
0 70%
1
4
Other
65%
70%
62%
61%
60%
Infection-Related
Event
12
13
2
170
Total patients impac
60%Drug Overdose
Inpatient
8
13
13
121
50%Death
Maternal
11
6
7
125
40%
Med Equipment-Related
9
14
10
238
Medication
20
47
33
476
30% Error
Op/Post-op
53
82
45
920
20% Complication
*Other settings includ
Other 10%
Unanticipated Event**
73
58
47
632
Imaging, Hospice Care
© Copyri
Perinatal
Death/Injury
35
43
23
362
0%
**Other
unanticipated
Radiation Overdose
2005
2006
2007
2008
2009
2010 4 2011
2012 4 2013
2014 4 2015
2016 46
Choked on food, Drow
Restraint Related Event
2
7
7
124
Self-Inflicted Injury
5
21
17
100
***Category unassign
This graph
illustrates
the
percentage of self-reported sentinel events
between 2005
Severe
Maternal
Morbidity
0
0 and 2016. 9
9
****Multiple patients
Severe Neonatal Hyperbilirubinemia
0
2
0
8
Suicide
84
98
87
1013
Sentinel Event” (see a screenshot of this tool in Figure 2-4,
method for sharing the comprehensive systematic analysis
Transfer-Related Event
2
1
2
30
page 26). Transfusion Error
and
plan and will
due date.
7 corrective action
9
5 confirm the127
Unassigned***
4
3
70
77
Unintended
of a Foreign
116
120
1231
The organization
willRetention
be contacted
by a Body
Joint Commission
Addressing123
Concerns About
Reporting
Utility System Failure
0
1
1
9
Concerns
about 3potential legal issues
can give an
organizapatient safety
specialist to determine whether the event
Ventilator Death
3
2
54
tion
pause
before
reporting.
Often
the
chief
concern
is that
meets the definition
of
a
sentinel
event.
After
the
event
is
Wrong–patient, wrong-site, wrong-procedure
73
120
104
1281
Total
Incidents
Reviewed
764
936
824
9945
a comprehensive systematic analysis will be obtained and
identified as a sentinel event, the specialist will confirm the
23
Percent Self Reported of Sentinel
Events, 2005 to 2016
90%
80%
69%
71%
69%
72%
70%
76%
75%
81%
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Table 2-1. Types of Sentinel Events
Type of Sentinel Event
2014
Anesthesia-Related Event
2014
2014
2005 to 2016
6
7
4
Criminal Event
47
47
32
442
Delay In Treatment
79
83
54
1068
Dialysis-Related Event
2
0
7
19
Elopement
6
7
9
103
Fall
93
95
92
869
Fire
10
26
15
150
Infant Abduction
0
3
2
29
Infant Discharge to Wrong Family
0
0
1
4
Infection-Related Event
12
13
2
170
Inpatient Drug Overdose
8
13
13
121
Maternal Death
108
11
6
7
125
9
14
10
238
Medication Error
20
47
33
476
Op/Post-op Complication
53
82
45
920
Other Unanticipated Event
73
58
47
632
Perinatal Death/Injury
35
43
23
362
Radiation Overdose
4
4
4
46
Restraint Related Event
2
7
7
124
Self-Inflicted Injury
5
21
17
100
Severe Maternal Morbidity
0
0
9
9
Med Equipment-Related
Severe Neonatal Hyperbilirubinemia
0
2
0
8
84
98
87
1013
Transfer-Related Event
2
1
2
30
Transfusion Error
7
9
5
127
Suicide
Unassigned
4
3
70
77
116
123
120
1231
Utility System Failure
0
1
1
9
Ventilator Death
3
3
2
54
Unintended Retention of a Foreign Body
Wrong–patient, wrong-site, wrong-procedure
Total Incidents Reviewed
73
120
104
1281
764
936
824
9945
used in a lawsuit against the organization. Organizations
should be aware that it would be very difficult for any
parties to obtain access to that information under any
circumstances. In the event of a subpoena, The Joint
Commission adheres to its Public Information Policy.
Joint Commission becomes aware of the event, the orga­
nization must share relevant information with The Joint
Commission. Almost all organizations experiencing
sentinel events appear to be moving quickly to address
the first tenet. However, among other reasons, The Joint
Commission has been told that serious concerns regarding
the potential discoverability of sentinel event–related
information shared with The Joint Commission have
created a significant barrier to organizations meeting the
second tenet.
Legal Concerns Over Confidentiality
The basic tenets of the Sentinel Event Policy are that an
organization must perform a comprehensive systematic
analysis in response to a sentinel event and that if The
24
CHAPTER 2
| Addressing Sentinel Events in Policy and Strategy
Sidebar 2-4. State and Federal Reporting Requirements
In addition to reporting sentinel events to The Joint Commission, many hospitals are required to report patient safety
events at the state level. Also many hospitals voluntarily report as Patient Safety Organizations that were established with
the passage of the Patient Safety and Quality Improvement Act of 2005 (http://www.pso.ahrq.gov).
The National Academy for State Health Policy (NASHP) collected information about all state adverse event reporting
systems. As of January 1, 2015, the shaded states were found to have reporting systems.
California
Colorado
Connecticut
District of Columbia
Florida
Georgia
Illinois
Indiana
Kansas
Maine
Maryland
Massachusetts
Minnesota
Nevada
New Hampshire
New Jersey
New York
Ohio
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Washington
NASHP made the following findings:
►► The number of adverse event reporting systems has changed for the first time since 2007, with Texas in January 2015
becoming the 28th state to adopt such a system. There continues to be wide variation in the types of individual events
reported to states. In 2014, 15 states have adopted or adapted the National Quality Forum’s list—a slight increase from
2007.
►► Reporting systems are now more technologically advanced. Twenty-two systems are now partially or fully electronic,
compared to nine in 2007.
►► Communication of findings to providers and the public continues to be common, with 22 systems publicly reporting
data and 20 sharing system data with facilities. Eight states have increased the frequency of public reporting
since 2007.
►► Formal evaluations of reporting systems are rare (three states); however officials from most (23) systems have
­ necdotal, survey, or other sources indicating an impact on communication among facilities, provider education, internal
a
agency tracking or trending, and/or implementation of facility processes to address quality of care. Nine states report
increased levels of provider and facility transparency and awareness of patient safety as a result of their reporting
systems.
►► System officials partner with provider, patient safety, and state agency representatives to carry out patient safety
i­nitiatives. Despite potential opportunities in delivery system and payment reform, there are few specific examples
of states integrating adverse event reporting systems with statewide quality improvement or other initiatives that
­demonstrate the importance of patient safety as a crosscutting statewide priority.
Source: Adapted from Hanlon C, et al. 2014 Guide to State Adverse Event Reporting Systems. Portland, ME: National Academy for State Health Policy, 2015.
Accessed Mar 9, 2017. http://www.nashp.org/sites/default/files/2014_Guide_to_State_Adverse_Event_Reporting_Systems.pdf.
25
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 2-4. Sentinel Event Reporting Tool
Accredited health care organizations can use this tool to self-report a sentinel event via their
Joint Commission Connect™ extranet site.
regarding the organization’s response to a sentinel event.
These alternatives are intended to offer methods for sharing
information with The Joint Commission that some lawyers
and organizations may find provide additional comfort
about any potential exposure of sensitive sentinel event–
related information (see Sidebar 2-5, page 27). Questions
regarding legal protections of sentinel event information
can be directed to the Office of the General Counsel.
Contact information under “Legal Issues” can be found
online at https://www.jointcommission.org/contact
_directory/?CategoryId=73.
TIP
If you are uncertain whether a patient safety event
meets the definition of a sentinel event, err on
the side of caution by reporting the event. Selfreporting does not automatically mean that an
incident will be considered a sentinel event.
The Joint Commission’s patient safety specialists
can help the organization make that determination.
The Joint Commission is there to help the
organization through the process, and patient
safety specialists may work with the organization to
identify potential solutions even if the incident does
not meet the definition of a sentinel event.
Sentinel Events That Are Not Reported
by the Organization
The Joint Commission sometimes becomes aware of a
sentinel event through other means besides self-reporting,
such as through media reports or calls from patients or their
families. Whether the organization voluntarily reports the
To meet these concerns, The Joint Commission offers
several alternative ways for a health care organization to
report, and The Joint Commission to review, information
26
CHAPTER 2
event or The Joint Commission becomes aware of the event
by some other means, there is no difference in the expected
response, time frames, or review procedures.
| Addressing Sentinel Events in Policy and Strategy
organization is required to submit or make available an
acceptable root cause analysis and corrective action plan, or
choose an approved comprehensive systematic analysis tool
within 45 calendar days of the event or becoming aware of
the event.
If The Joint Commission becomes aware of a sentinel
event that was not reported to The Joint Commission by
an accredited organization, the chief executive officer of
the organization, or his or her designee, is contacted, and
a preliminary assessment of the sentinel event is made. If
the occurrence meets the definition of a sentinel event, the
Disclosable Information
If, during the 45-day analysis period, The Joint
Commission receives an inquiry about the accreditation
status of an organization that has experienced a sentinel
Sidebar 2-5. Reporting Alternatives
Alternative 3
The organization conducts its comprehensive systematic
analysis and creates a corrective action plan. The organization and a Joint Commission patient safety specialist
discuss the sentinel event and review the corrective action
plan and relevant documentation (including, at a minimum,
any documentation relevant to the organization’s process
for responding to sentinel events). The patient safety
specialist may ask questions regarding the comprehensive systematic analysis, but will not review that document
itself. The corrective action plan serves as the basis for
determining appropriate follow-up activity. This review can
be performed on site at the organization or via web-based
video conferencing with a patient safety specialist who is
located at The Joint Commission.
A health care organization that self-reports a sentinel
event to The Joint Commission (or experiences a
sentinel event that is otherwise made known to The Joint
Commission) must conduct a comprehensive systematic
analysis and create a corrective action plan that describes
the organization’s risk-reduction strategies as well as
how the effectiveness of those strategies will be evaluated. The Joint Commission created several alternatives
for how this information is submitted if the organization
has concerns about waiving confidentiality protections
as a result of sending the comprehensive systematic
analysis documents to The Joint Commission. The Joint
Commission must receive a request for review of a health
care organization’s response to a sentinel event using any
of these options within five business days of the self-report
of a sentinel event or of the initial communication by The
Joint Commission to the organizations that it has become
aware of a sentinel event.
Alternative 4
A specially trained surveyor conducts a standards-based
survey to trace patient care, treatment, and services as
well as the management functions relevant to the sentinel
event under review. The surveyor does the following:
Alternative 1
The organization conducts its comprehensive systematic
analysis and creates a corrective action plan, and organization staff bring the documents to Joint Commission
headquarters for review then take them back to the
organization on the same day. This review can be
conducted at Joint Commission headquarters or
performed via web-based video conferencing with a
patient safety specialist who is located at The Joint
Commission and the organization participants remain at
the health care organization.
►► Interviews staff
►► Reviews relevant documentation (including, if appli-
cable, the patient’s medical record)
►► Evaluates the process the organization uses in
responding to sentinel events
►► Examines the relevant policies and procedures
preceding and following the organization’s own
review of the specific event, making inferences about
the adequacy of the organization’s response to the
sentinel event
Alternative 2
The organization conducts its comprehensive systematic
analysis and creates a corrective action plan and shares
the documents with a Joint Commission patient safety
specialist. This review can be conducted at the health care
organization or performed via web-based video conferencing with a patient safety specialist who is located at
The Joint Commission.
Each of these options will result in a fee to the
hospital to cover the average direct costs of the option.
Inquiries about the fee should be directed to The Joint
Commission’s Pricing Unit at 630-792-5115.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
event, the organization’s accreditation status is reported in
the usual manner without making reference to the sentinel
event. If the inquirer specifically references the sentinel
event, The Joint Commission acknowledges that it is
aware of the event and is working with the organization
through the sentinel event review process. All comprehensive systematic analysis tools including RCAs and corrective
action plans will be considered and treated as confidential
by The Joint Commission in accordance with The Joint
Commission’s Public Information Policy.
The Joint Commission’s website at http://www
.jointcommission.org. The root cause analysis and
corrective action plan are not to include the patient’s name
or the names of caregivers involved in the sentinel event.
Reporting Options
The handling of sensitive documents regarding sentinel
events is restricted to specially trained Joint Commission
staff in accordance with procedures designed to protect the
confidentiality of the documents. An organization that has
experienced a sentinel event has several alternate methods
for sharing information with The Joint Commission.
These sharing options include electronic submission and
on-site interaction:
• Electronic submission. The organization submits its root
cause analysis and corrective action plan via the secure
and encrypted extranet, The Joint Commission Connect™
(also called Alternative 0). The organization will be
contacted by telephone upon completion of The Joint
Commission’s review.
• On-site interaction. This option involves a face- toface dialogue between the organization and The Joint
Commission. It may take place in one of four ways, as
described in previous Sidebar 2-5.
Required Response to a Sentinel Event
If The Joint Commission becomes aware of a sentinel event
in an accredited organization, and the occurrence meets the
definition of a sentinel event, the organization is required to
do the following:
• Prepare a thorough and credible comprehensive
systematic analysis and corrective action plan within
45 business days of the event or of becoming aware
of the event. Root cause analysis is the most common
type of comprehensive systematic analysis used by Joint
Commission–accredited organizations.
• Select and provide information under an approved
alternative protocol within 45 business days of the
known occurrence of the event.
The Joint Commission’s Review of the Root
Cause Analysis and Corrective Action Plan
The Joint Commission will then determine whether the
root cause analysis and corrective action plan are acceptable.
If the determination that an event is sentinel occurs more
than 45 business days following the known occurrence of
the event, the organization will be allowed 15 calendar days
for its response.
An organization that experiences a sentinel event is required
to complete two documents:
1. The root cause analysis, which includes enough detail to
demonstrate that the analysis is thorough and credible
2. The resulting corrective action plan that describes the
organization’s risk-reduction strategies and plan for
evaluating their effectiveness.
Joint Commission staff members assess the acceptability of
an organization’s response to a sentinel event, including the
thoroughness and credibility of any root cause analysis
information reviewed and the organization’s corrective
action plan. A corrective action plan will be acceptable if it
meets the following criteria:
• Identifies and implements actions to eliminate or control
systems hazards or vulnerabilities
• Identifies, in situations in which improvement actions
are planned, who is responsible for implementation,
when the action will be implemented, how the
effectiveness of the actions will be evaluated, and how
the actions will be sustained
• Identifies at least one stronger or intermediate strength
action for each root cause analysis
A framework for a root cause analysis and corrective action
plan (see the Appendix) is available to organizations as an
aid in organizing the steps in a root cause analysis and
developing a corrective action plan. It is also available on
If the root cause analysis or corrective action plan is not
acceptable, The Joint Commission will work with the organization to facilitate development of a thorough and credible root cause analysis and corrective action plan.
Submission of Root Cause Analysis and
Corrective Action Plan
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CHAPTER 2
Follow-Up Activity
| Addressing Sentinel Events in Policy and Strategy
of information sharing. In handling sentinel event–related
documents, The Joint Commission destroys original root
cause analysis documents and any copies, or, upon request,
returns the original documents to the organization. In
accordance with procedures designed to protect the confidentiality of the documents, only specially trained Joint
Commission staff handle these sensitive documents.
Through the completion of the root cause analysis, the
organization is able to identify important contributing
factors to a sentinel event. The organization develops a
corrective action plan to mitigate the possible recurrence of
such an event. The measure of success (MOS) process for all
accreditation and certification programs in response to
requirements for improvement found onsite was discontinued January 1, 2017, as part of the changes to the
post-survey follow-up process under Project REFRESH.
However, the Sentinel Event MOS process is unchanged
and still in effect. The Joint Commission requires that
organizations measure the effectiveness of improvement
activities. This measurement is most frequently accomplished through a Sentinel Event Measure of Success (SE
MOS). An SE MOS is a numerical or quantifiable measure
usually related to an audit that determines if a planned
action was effective and sustained. (In some instances, The
Joint Commission will consider other forms of mutually
agreed-upon follow-up activities to evaluate the effectiveness of a corrective action plan.)
The corrective action plan resulting from the analysis of
the sentinel event is initially retained to serve as the basis for
the follow-up activity. After the organization implements the
corrective action plan to the satisfaction of The Joint
Commission, as determined through follow-up activities, The
Joint Commission also destroys the corrective action plan.
Joint Commission International’s Sentinel
Event Policy
The JCI Sentinel Event Policy, applicable to accredited
organizations outside the United States, has similarities to
that of The Joint Commission.1 (For a comparison of the
two sentinel event policies, see Table 2-2, pages 32–33).
Reporting of sentinel events to JCI is voluntary but encouraged. JCI’s definition of a sentinel event takes into account
a wide array of occurrences applicable to a wide variety
of health care organizations. Sentinel events are unanticipated occurrences that involve death or serious physical
or psychological injury. Such events include but are not
limited to the following, which are subject to review by JCI:
• Unanticipated death, including but not limited to
death unrelated to the natural course of the patient’s
illness or underlying condition, death of a full-term
infant, and suicide
• Major permanent loss of function unrelated to the
natural course of the patient’s illness or underlying
condition
• Wrong-site, wrong-procedure, wrong-patient surgery
• Transmission of a chronic or fatal disease or illness
as a result of infusing blood or blood products or
transplanting contaminated organs or tissues
• Infant abduction
• Rape, workplace violence leading to death or
permanent loss of function, or homicide on the
organization’s property
Upon the organization’s submission of SE MOS data indicating sustainability of the improvement efforts, The Joint
Commission will close the file as complete. The information will be de-identified and entered into the Sentinel
Event Database, as discussed in the following section.
The Sentinel Event Database
To achieve the third goal of the Sentinel Event Policy—to
increase the general knowledge about sentinel events, their
causes, and strategies for prevention—The Joint
Commission collects and analyzes data from the review of
sentinel events, root cause analyses, corrective action plans,
and follow-up activities. These data and information
form the content of The Joint Commission’s Sentinel
Event Database.
The Joint Commission develops and maintains the Sentinel
Event Database in a manner that excludes organization,
caregiver, and patient identifiers.
Aggregate data relating to root causes and risk-reduction strategies for sentinel events that occur with significant frequency form the basis for future error-prevention
advice to health care organizations through Sentinel Event
Alerts, National Patient Safety Goals, and other methods
If, either through voluntary reporting by the accredited organization or through other means (such as
29
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
communications from a patient, a patient’s family member,
employees, the media, or identification by a survey team
during an onsite survey), JCI becomes aware of the occurrence of a sentinel event, then the event becomes subject
to JCI’s Sentinel Event Policy. In that case, the organization is expected to prepare a thorough and credible corrective action plan within 45 calendar days of the event or of
becoming aware of the event and then submit its root cause
analysis and corrective action plan to JCI for evaluation.
JCI then determines whether or not the plans are acceptable. All root cause analyses and corrective action plans are
considered and treated by JCI as confidential.
•
•
A root cause analysis will be considered acceptable by JCI
if it has the following characteristics:
• The analysis focuses primarily on systems and processes,
not individual performance.
• The analysis progresses from specific causes in the
clinical care process to common causes in the
organizational process.
• The analysis repeatedly digs deeper.
• The analysis identifies changes that could be made
in systems and processes (either through redesign or
development of new systems or processes) that would
reduce the risk of such events occurring in the future.
•
•
•
•
Although reporting a sentinel event to JCI is voluntary, an
organization may be required to report sentinel events to a
governmental or private agency within its country.
Related Joint Commission
International Standards
Quality Improvement and Patient Safety (QPS) standards
require that qualified individuals guide the implementation
of the organization’s program for quality improvement and
patient safety and manage the activities needed to carry out
an effective program of continuous quality improvement
and patient safety within the organization.
•
Additional requirements include the following:
• An individual(s) who is experienced in the methods
and processes of improvement is selected to guide the
implementation of the organization’s quality and patient
safety program.
• The individual(s) with oversight for the quality program
selects and supports qualified staff for the program
30
and supports those staff with quality and patient safety
responsibilities throughout the organization.
The quality program provides support and coordination
to department/service leaders for like measures across
the organization and for the organization’s priorities
for improvement.
–– The quality program implements a training program
for all staff that is consistent with staff’s roles in the
quality improvement and patient safety program.
–– The quality program is responsible for the regular
communication of quality issues to all staff.
The organization uses a defined process for identifying
and managing sentinel events.
Organization leadership has established a definition of
a sentinel event that at least includes the occurrences in
the box below (see Standard QPS.7 in the JCI Hospital
Standards, 6th Edition).
The organization completes a root cause analysis of all
sentinel events in a time period specified by organization
leadership that does not exceed 45 days from the date of
the event or when made aware of the event.
Organization leadership takes action on the results of the
root cause analysis.
Those responsible for governance approve the
organization’s program for quality and patient safety and
regularly receive and act on reports of the quality and
patient safety program.
–– Those responsible for governance annually
approve the organization’s program for quality
and patient safety.
–– Those responsible for governance at least quarterly
receive and act on reports of the quality and patient
safety program, including reports of adverse and
sentinel events.
–– Minutes reflect actions taken and any follow-up on
those actions.
Organization leadership communicates quality
improvement and patient safety information to
governance and organization staff on a regular basis.
–– Organization leadership reports on the quality and
patient safety program quarterly to governance.
–– Organization leadership reports to governance
include, at least quarterly, the number and type of
sentinel events and root causes, whether the patients
and families were informed of the sentinel event,
actions taken to improve safety in response to sentinel
events, and if the improvements were sustained.
CHAPTER 2
•
•
•
•
–– Information on the quality improvement and patient
safety program is regularly communicated to staff,
including progress on meeting the International
Patient Safety Goals.
The organization integrates the human subjects research
program (as applicable) into the quality and patient
safety program of the organization.
The research program is a component of the
organization’s processes to report and act on sentinel
events, adverse events of other types, and the processes to
learn from close calls.
The research program is included in the organization’s
programs for hazardous material management, medical
technology management, and medication management.
The evaluation of staff participating in the research
program is incorporated into the ongoing monitoring
processes of professional performance.
| Addressing Sentinel Events in Policy and Strategy
• All unusual events, even though they may result in only
minor adverse outcomes
• All events that must be reported to an external agency
• Events with potential for an adverse public, economic, or
regulatory impact
An organization’s definition should, at a minimum, include
those events that meet the definition of a sentinel event
under The Joint Commission’s Sentinel Event Policy or
for international accredited organizations, the requirements of the sentinel event standard in the JCI standards.
The definition should also apply organizationwide and
should appear in writing in an organization plan or policy.
Through a collaborative process, organization leaders as well
as medical, nursing, and administrative staff should develop
the definitions or categories of events that warrant root
cause analysis.
Developing Your Own Sentinel Event Policy
In developing the organization’s sentinel event policy,
leaders may also address the process for reporting a sentinel
event to leadership, how organizations should handle close
calls, and the process for the ongoing management of
patient safety events and prevention efforts.
Although The Joint Commission requires organizations to
define the term sentinel event and communicate its definition throughout the organization, it does not require
organizations to develop a sentinel event policy. The information provided here is intended to provide advice on how
an organization might develop a sentinel event policy if it
wishes to do so. Both US–based and international health
care organizations should consider developing their own
sentinel event policy. The first step in developing an organization’s sentinel event policy is to determine which patient
safety events warrant in-depth analysis.
Leaders may also wish to identify the following:
• The individual responsible for receiving initial
notification of a sentinel event
• The individual responsible for assessing whether or not
the event warrants an in-depth root cause analysis based
on the organization’s definition of a sentinel event (this
may be the same individual—for example, a physician,
risk manager, quality assurance coordinator, or program
manager)
• How this individual communicates the need for indepth investigation and necessary information to a team
of individuals responsible for performing the root cause
analysis
• The individual responsible for facilitating and overseeing
a team-based root cause analysis process
The Joint Commission expects accredited organizations to
identify and respond appropriately to all sentinel events, as
defined by The Joint Commission and the organization,
occurring in the organization or associated with services
that the organization provides or provides for. Doing so
helps ensure improvement of the organization’s processes.
As outlined earlier, appropriate response includes a thorough and credible RCA, implementing improvements
to reduce risk, and monitoring of the effectiveness of
those improvements.
Safe Reporting
However the organization designs its sentinel event policy,
it is critical that the process be transparent. Transparency
builds trust within the organization and encourages staff to
report errors, adverse events, and dangerous conditions. The
culture of safety propagated by an open, honest reporting
Defining a Sentinel Event
An organization may wish to define a sentinel event as a
serious event involving staff and visitors as well as patients.
Or an organization may wish to include the following:
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Table 2-2. Comparison of The Joint Commission and Joint Commission International
Sentinel Event Policies and Related Requirements
The Joint Commission Sentinel
Event Policy
Joint Commission International (JCI) Sentinel Event
Policy and Related Requirements
Definition of Sentinel
Event
A patient safety event (not primarily related to the
natural course of the patient’s illness or underlying
condition) that reaches a patient and results in any
of the following:
• Death
• Permanent harm
• Severe temporary harm
An unanticipated occurrence involving death or
serious physical or psychological injury. Serious
physical injury specifically includes loss of limb or
function.
Other Information
About Sentinel
Events
Such events are called “sentinel” because they
signal the need for immediate investi­gation and
response. The terms sentinel event and medical
error are not synonymous; not all sentinel events
occur because of an error and not all errors result in
sentinel events.
Such events are called “sentinel” because they
signal a need for immediate investigation and
response. The terms sentinel event and medical
error are not synonymous; not all sentinel events
occur because of an error and not all errors result in
sentinel events.
Goals of the Sentinel
Event Policy
1. To have a positive impact in improving patient
care, treatment, and services and in preventing
unintended harm
2. To focus the attention of a hospital that has
experienced a sentinel event on understanding
the factors that contributed to the event (such as
underlying causes, latent conditions and active
failures in defense systems, or hospital culture),
and on changing the hospital’s culture, systems,
and processes to reduce the probability of such
an event in the future
3. To increase the general knowledge about patient
safety events, their contributing factors, and
strategies for prevention
4. To maintain the confidence of the public, clinicians,
and hospitals that patient safety is a priority in
accredited hospitals
1. To have a positive impact in improving patient care,
treatment, and services and preventing sentinel
events
2. To focus the attention of an organization that has
experienced a sentinel event on understanding
the causes that underlie that event and on
changing the organization’s systems and
processes to reduce the probability of such an
event in the future
3. To increase general knowledge about sentinel
events, their causes, and strategies for prevention
4. To maintain the confidence of the public and
internationally accredited organizations in the
accreditation process
Organization-specific
Definition of Sentinel
Event
Standards require each accredited organization to
define patient safety event and communicate this
definition throughout the organization. At a minimum,
an organization’s definition must encompass sentinel
events as defined by The Joint Commission. An
accredited organization is encouraged to include
in its definition events, incidents, and conditions in
which no or only minor harm occurred to a patient.
The hospital determines how it will respond to
patient safety events that do not meet the Joint
Commission definition of a sentinel event.
Standards require each accredited organization to
establish an operational definition of sentinel event
and a process for the in-depth analysis of such
events.
When developing the definition, accredited
organizations must include at least those events
that are described in the sentinel event standard
within the JCI standards. Such events include
death related to the natural course of the patient’s
illness or underlying condition; major permanent
loss of function unrelated to the natural course of
the patient’s illness or underlying condition; wrongsite, wrong-procedure, wrong-patient surgery;
transmission of a chronic or fatal disease or illness
as a result of infusing blood or blood products or
transplanting contaminated organs or tissues; infant
abduction; rape, workplace violence leading to death
or permanent loss of function, or homicide on the
organization’s property.
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CHAPTER 2
| Addressing Sentinel Events in Policy and Strategy
Table 2-2. Comparison of The Joint Commission and Joint Commission International
Sentinel Event Policies and Related Requirements
The Joint Commission Sentinel
Event Policy
Joint Commission International (JCI) Sentinel Event
Policy and Related Requirements
Self-Reporting a
Sentinel Event
Encouraged but not required
Encouraged but not required
Sentinel Events
All sentinel events must be reviewed by the
organization and are subject to review by The Joint
Commission.
Accredited organizations are expected to identify
and respond appropriately to all sentinel events
occurring in the organization or associated with
services that the organization provides.
Expectations for
an Organization’s
Response to a
Sentinel Event
Prepare a thorough and credible root cause analysis
and corrective action plan within 45 business days of
the event or of becoming aware of the event.
Appropriate response includes conducting a
timely, thorough, and credible root cause analysis;
developing an action plan designed to implement
improvements to reduce risk; implementing the
improvements; and monitoring the effectiveness
of the improvements. When JCI becomes aware
of a sentinel event in an accredited organization,
the organization is expected to prepare a thorough
and credible action plan within 45 calendar days of
the event or of becoming aware of the event and
to submit to JCI its root cause analysis and action
plan or otherwise provide for JCI evaluation of its
response to the sentinel event.
Confidentiality
All root cause analyses and corrective action plans
will be considered and treated as confidential by
The Joint Commission in accordance with the Joint
Commission’s Public Information Policy.
All root cause analyses and action plans will be
considered and treated as confidential by JCI.
Follow-Up to Review
Organizations are required to measure the
effectiveness of the improvement activities outlined
in the corrective action plan accepted by The
Joint Commission. This measurement is done
through a Sentinel Event Measure of Success (SE
MOS) submission. If the SE MOS data indicate
sustainability of improvement efforts, the file will be
closed as complete.
Upon acceptance of the organization’s root
cause analysis and action plan, JCI will assign an
appropriate follow-up activity, typically a written
progress report due in four months.
Staff Orientation and Training
and investigative process, one that focuses on systems
and processes, is a necessary condition for creating a high
reliability organization.
Following the development of the organization’s sentinel
event policy, leaders should ensure that all staff and physicians are knowledgeable about the organization’s sentinel
event policies and procedures. In-service programs and
new staff and physician orientation should address the
organization’s sentinel event policy on a regular and
continuing basis, including regular updates concerning
sentinel events published by The Joint Commission and
additional issues that may be identified through the
organization’s compliance with the National Patient Safety
Goals. Figure 2-5 provides a checklist that outlines the steps
described in this section.
Addressing Discoverability and Disclosure
Leaders should also address confidentiality, discoverability,
and disclosure. Information obtained during the investigation of sentinel events through RCA or other techniques
is often highly sensitive. The organization’s sentinel event
policy should address how confidentiality will be protected.
The policy should also address the procedure for obtaining
legal consultation to protect relevant documents such as
meeting minutes, reports, and conversations from discovery
in the event of a future lawsuit. The policy should be clear
on whether the state in which the organization operates
protects the details of a sentinel event investigation from
discovery under the organization’s quality management,
peer review, or risk management programs.
Leadership, Culture, and Patient
Safety Events
For the sentinel event policy to be effective, the culture of
an organization and the role of its leaders need to support
33
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 2-5. Optional Sentinel Event Policy Evaluation Checklist
Defining
Y
N
N/A
Comments
Y
N
N/A
Comments
Y
N
N/A
Comments
DOWNLOAD
The policy defines the term sentinel event, in
writing, setting specific parameters for what
constitutes unexpected, serious. (Remember that
the general definition must be consistent with The
Joint Commission’s definition.)
The policy determines which events warrant root
cause analysis using a collaborative process
The policy determines how close calls are to
be handled
Reporting
The policy outlines a process for reporting a
sentinel event
The policy determines the process for reporting a
sentinel event to leadership
The policy determines the process for reporting
the event to external agencies
Managing
The policy outlines the management of sentinel
events, including conducting thorough and
credible root cause analysis, implementing
improvements to reduce risk, and monitoring of
the effectiveness of those improvements
The policy addresses how confidentiality
of information related to sentinel events will
be protected
The policy address disclosure and the procedure
for obtaining legal consultation to protect
relevant documents
The policy addresses staff and physician
education about the policy and procedures and
outlines ongoing education
The policy is reviewed annually and revised
as appropriate
This checklist includes criteria that should be a part of an effective organization Sentinel Event Policy, should your
organization decide to have such a policy. You can use it to evaluate whether your policy addresses everything it should.
Answers to all questions should ideally be Y for Yes (unless they aren’t applicable).
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CHAPTER 2
| Addressing Sentinel Events in Policy and Strategy
DOWNLOAD
the prevention and identification of sentinel events,
as described in The Joint Commission’s Sentinel Event
Alert #57 entitled “The Essential Role of Leadership in
Developing a Safety Culture” (see the central tenets of the
Alert in Figure 2-6).
Figure 2-6. 11 Tenets of a Safety Culture
Definition of Safety Culture
Safety culture is the sum of what an organization is
and does in the pursuit of safety. The Patient Safety
Systems (PS) chapter of The Joint Commission
accreditation manuals defines safety culture as the
product of individual and group beliefs, values, attitudes, perceptions, competencies, and patterns of
behavior that determine the organization’s commitment
to quality and patient safety.
Leadership
Leaders must be deeply committed to patient safety and to
ensuring that members of their organization truly embody
their mission, vision, and values. They play a critical role in
fostering an organization culture in which patient safety
event reporting, root cause analyses, and proactive risk
reduction are encouraged. Competent and thoughtful
leaders contribute to improvements in safety and organizational culture. They understand that systemic flaws exist
and each step in a care process has the potential for failure
simply because humans make mistakes. Reporting helps an
organization start the process of both identifying root
causes and developing and implementing risk-reduction
strategies. Leaders who understand that continuous
improvement is essential to an organization’s success must
have the authority and willingness to allocate resources for
root cause analyses and improvement initiatives. They must
ensure that the processes for identifying and managing
patient safety events are defined and implemented. They
must be willing and able to set an example for the organization and empower staff to identify and bring about necessary change. Effective leaders empower staff throughout the
organization to acquire and apply the knowledge and skills
needed to continuously improve processes and services.
1. Apply a transparent, nonpunitive approach to reporting
and learning from adverse events, close calls, and
unsafe conditions.
2. Use clear, just, and transparent risk-based processes for
recognizing and distinguishing human errors and system
errors from unsafe, blameworthy actions.
3. CEOs and all leaders adopt and model appropriate behaviors and champion efforts to eradicate
intimidating behaviors.
4. Policies support safety culture and the reporting of
adverse events, close calls, and unsafe conditions. These
policies are enforced and communicated to all team
members.
5. Recognize care team members who report adverse
events and close calls, who identify unsafe conditions,
or who have good suggestions for safety improvements.
Share these “free lessons” with all team members (i.e.,
feedback loop).
6. Determine an organizational baseline measure on safety
culture performance using a validated tool.
7. Analyze safety culture survey results from across
the organization to find opportunities for quality and
safety improvement.
8. Use information from safety assessments and/or surveys
to develop and implement unit-based quality and safety
improvement initiatives designed to improve the culture
of safety.
Safety Culture
A robust safety culture is a crucial component to becoming
a high reliability organization—a goal for many Joint
Commission–accredited organizations. An organization’s
response to a patient safety event speaks volumes about
its culture. Its response can also significantly influence the
likelihood of similar events in the future. Historically, the
response to sentinel events has been to identify the individual(s) most closely associated with the event and take some
form of punitive action. “Who did it?” has too often been
the first question asked, rather than “Why did it happen?”
9. Embed safety culture team training into quality improvement projects and organizational processes to strengthen
safety systems.
10. Proactively assess system strengths and vulnerabilities
and prioritize them for enhancement or improvement.
11. Repeat organizational assessment of safety culture
every 18 to 24 months to review progress and
sustain improvement.
The list above provides guidelines for leadership
to implement a strong safety culture initiative in
its organization. See Sentinel Event Alert Issue 57,
“The essential role of leadership in developing a
safety culture,” for more information, resources,
and references.
The organization that routinely asks “Why?” rather than
“Who?” will, over time, learn more about the quality and
safety of the care it is providing—as well as its sentinel
events, close calls, and hazardous conditions—and will
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Early Response Strategies
better understand the relationship between its staff
members and the processes, systems, and environment in
which they function.2
An organization has just experienced a sentinel event
leading to a serious adverse outcome. What must be done?
Following the occurrence of a sentinel event, staff members
must simultaneously take a number of actions. An organization’s sentinel event policy should outline early response
strategies. These strategies include the following:
• Providing prompt and appropriate care for the
affected patient(s)
• Containing the risk of an immediate recurrence of
the event
• Preserving the evidence
Performance Improvement
Through commitment to performance improvement,
patient safety, and proactive risk reduction, leaders build
an organization culture that values change, creativity,
teamwork, and communication (see Sidebar 2-6, below).
Teams provide much of the impetus for performance
improvement. Communication and information flow
throughout the organization to foster a barrier-free learning
environment. (See the “Patient Safety Systems” [PS] chapter
in the applicable Comprehensive Accreditation Manual
for information on how standards provide the infrastructure
for these efforts.)
Appropriate Care
The prompt and proper care of a patient who has been
affected by a sentinel event should be the providers’ and
Sidebar 2-6.
Root Cause Analysis Training: Case Example
root cause analysis and contribute to overall patient safety
and quality of care.
DaVita Hospital Services Group provides comprehensive
24-hour inpatient kidney care in more than 980
hospitals nationwide, delivering more than one million
treatments daily.
Curriculum Development
The effort to better educate staff on root cause analysis resulted in the development of a document titled
“Analyzing Root Cause Analysis: It’s a Good Thing!”
introduced in February 2016. The document was created
by DaVita’s Clinical Education and Clinical Services
departments and the Hospital Services Group’s medical
director. The document combines fictional examples
with Joint Commission–recommended processes into a
lesson format that explains root cause analysis, why it is
important, how it is applied effectively, and its importance
within a culture of safety.
In 2015, DaVita’s leadership noticed that its staff members
were increasingly being asked to participate in the root
cause analysis (RCA) process for investigating sentinel
events at the hospitals in which they work as contractors.
According to Miki Smith, national director of operations,
Hospital Services, DaVita Healthcare Partners Inc., DaVita
performs its own root cause analysis when patient safety
events occur. However, she explains, many of the organization’s nursing staff did not understand the process well,
which led to uncertainty and fear about the process.
“The new curriculum makes it very clear that RCA is not
intended to point the finger at an individual person, but
to identify flaws in the process,” Smith says. She explains
that the goal is to shift the staff members’ perception of
root cause analysis from “Oh no, I did something wrong” to
“Let’s figure out what happened so we can fix it.”
“Some of our nurses were afraid to participate in the root
cause analysis process,” Smith says. “They were afraid
of saying the wrong thing, or perhaps being blamed for
an incident.”
Training Needs
DaVita responded by examining its staff education and
training curriculum. All newly hired staff members undergo
training before starting work. Many of the nurses have
chronic dialysis experience but do not necessarily have
experience in a clinical hospital environment. DaVita
recognized that more information was needed to help its
3,000 nurses understand and maximize the benefits of
Smith says that DaVita has partnered with The Joint
Commission to achieve this goal. Joint Commission
speakers have given presentations on a culture of safety
to the organization’s staff. Also, The Joint Commission has
helped DaVita make the most of its existing programs
regarding a culture of safety.
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CHAPTER 2
| Addressing Sentinel Events in Policy and Strategy
Documentation
staff members’ first concern following the event. Care could
involve, as appropriate, stabilizing the patient, arranging
for his or her transportation to a health care facility for
surgery or testing, providing medications, taking actions
to prevent further harm, and reversing the harm that has
occurred, if possible. When appropriate, physicians should
obtain medical consultation related to the adverse event and
arrange to receive necessary follow-up information.
Proper medical record documentation of errors or sentinel
events is critical for the continuity of care. A thorough
incident-reporting form can be very helpful during the early
stages of event investigation and during steps 2 through
4 of root cause analysis (discussed in Chapters 3 and 4).
Health care organizations use a variety of occurrence or
incident-reporting tools and generally have a policy and
procedure covering their use. Forms or questionnaires may
be general in nature, covering all types of adverse events, or
be specific to event types. (See Figure 2-7, page 38, for an
incident tracking form.)
Risk Containment
Following a sentinel event, the organization must respond
by immediately containing the risk of the event occurring again. For example, if a patient suffered a stroke
after receiving an incorrect drug that looked very similar
to the correct drug and was stored in the same area, are
other patients at risk for the same type of incident? If so,
the organization must take immediate action to safeguard
patients from a repetition of the unwanted occurrence. In
the example given, one of the two drugs would immediately be moved to a separate storage area farther away from
the other. Risk management texts, articles appearing in the
literature, and associations such as the American Society
for Healthcare Risk Management (ASHRM) can provide
detailed guidance. Contact ASHRM by phone at 312-4223980 or go online at http://www.ashrm.org.
Communication
With the occurrence of a sentinel event, personnel involved
in the incident should promptly notify those responsible for
error reporting and investigation within the organization.
They should inform supervisors, quality and risk management professionals, and administrators. These individuals
can determine how best to notify other parties, including
the press and external agencies such as federal, state, and
local authorities. The organization should seek legal counsel
early in the process. Counsel can provide guidance on how
to discuss the situation with the patient and family, how to
prevent disclosure of potentially defamatory information,
and how to handle media relations.4
Preservation of Evidence
To learn from a failure and understand why it occurred,
it is critical to know exactly what occurred. Preserving the
evidence is essential to this process. Immediate steps should
be taken by staff to secure any biological specimens, medications, equipment, medical or other records, and any other
material that might be relevant to investigating the failure.3
In medication-related events, syringes of recently used
medications and bottles of medications should be preserved
and sequestered. Because such evidence may be discarded
as a part of routine operations, such as when empty vials
are thrown into trash cans, staff must obtain and preserve it
promptly. Protocols established by the health care organization should specify the steps to be taken to preserve relevant
evidence following a sentinel event.
One recommendation states that organizations maintain
two lists of key people to contact following a sentinel event:
(1) key individuals within the organization and (2) individuals outside the organization.5 Both lists should be kept
up-to-date with current telephone numbers and should be
accessible to managers, supervisors, and members of a crisis
management team. A sample sentinel event contact list
appears as Figure 2-8 on page 39.
Responding to media queries through organization protocols helps avert complications related to patient confidentiality, legal discovery, and heat-of-the-moment coverage.5
Organization policies and procedures should reflect notification requirements. They should include policies for
communication with the patient and family.
Event Investigation
Organizations must consider documentation and appropriate communication and disclosure to relevant parties
immediately following the occurrence of a sentinel event.
A provider’s communication and disclosure with relevant
parties following the occurrence of an event that led to or
could have led to patient injury is critical. Relevant parties
include the following:
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 2-7. Incident Tracking Form
DOWNLOAD
Organization: ________________________________________ Department/Unit: ___________________________
Date of Report: ________________ Reporter: _______________________________________________________
Location
Where did the incident occur?
Date/Time
When did the incident occur?
Status
What is the status of the incident?
Is it ongoing or complete?
Incident
What happened?
Describe the incident.
Basic information is needed to capture and communicate the details of an incident.
38
CHAPTER 2
| Addressing Sentinel Events in Policy and Strategy
Figure 2-8. Sentinel Event Communications Alert
DOWNLOAD
Organization: ________________________________________ Last Updated: ______________________________
Primary Contact Information
Backup Contact
Name
Position
Chief Executive Officer
Office phone and
hours available
Cell phone and
hours available
E-mail
Name
Position
Chief Medical Officer
Office phone and
hours available
Cell phone and
hours available
E-mail
Name
Position
Chief Nursing Officer
Office phone and
hours available
Cell phone and
hours available
E-mail
Name
Position
Risk Manager
Office phone and
hours available
Cell phone and
hours available
E-mail
continued
39
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 2-8. Sentinel Event Communications Alert continued
Primary Contact Information
Backup Contact
Name
Position
Legal Counsel
Office phone and
hours available
Cell phone and
hours available
E-mail
Name
Position
President, Governing Board
Office phone and
hours available
Cell phone and
hours available
E-mail
Name
Position
Chief Nursing Officer
Office phone and
hours available
Cell phone and
hours available
E-mail
Name
Position
Patient Liaison
Office phone and
hours available
Cell phone and
hours available
E-mail
40
CHAPTER 2
| Addressing Sentinel Events in Policy and Strategy
Figure 2-8. Sentinel Event Communications Alert continued
Primary Contact Information
Backup Contact
Name
Position
Office phone and
hours available
Cell phone and
hours available
E-mail
Name
Position
Office phone and
hours available
Cell phone and
hours available
E-mail
Name
Position
Office phone and
hours available
Cell phone and
hours available
E-mail
Name
Position
Office phone and
hours available
Cell phone and
hours available
E-mail
A list of key personnel who need to be made aware of the incident should be kept updated and
in an easily accessible location. Each contact should have a backup.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
• Patients and families affected by the event
• Colleagues who could provide clarification, support, and
the opportunity to learn from the error
• The health care organization’s and individual provider’s
liability insurers
• Appropriate organization staff, including risk managers
or quality assurance representatives
• Others who could provide emotional support or
problem-solving help
physician’s honesty and fallibility as a fellow human being.
One study reports that the risk of litigation nearly doubles
when patients are not informed by their physicians of
moderately serious mistakes.9 Figure 2-9, page 43, pro­
vides a checklist for physicians to follow in disclosing a
Communication and Optimal Resolution (CANDOR)
event to a patient or his or her family—which could be a
sentinel event.10 Please note that these are guidelines about
issues to consider, not Joint Commission requirements.
Organizations should be aware that the disclosure of an
error or event requires individualized handling. They should
involve risk management or legal counsel to help guide
communication with the patient and his or her family.
Conferring with other members of the care team following
an adverse event enables the provider to clarify factual
details and the proper sequence of what occurred. It can
also help identify what needs to be done in response.
Survey Process
Disclosure
In conducting an accreditation survey, Joint Commission
surveyors seek to evaluate the organization’s compliance
with the applicable requirements discussed in Chapter 1
and to score those requirements based on performance
throughout the organization over time (for example, the
preceding 12 months for a full accreditation survey). Under
the sentinel event requirements, accredited organizations
are expected to identify and respond appropriately to all
sentinel events occurring in the organization or associated
with services that the organization provides or provides for.
Good communication between providers and patients is
instrumental in achieving positive care outcomes. Yet health
care professionals often do not tell patients or families
about their mistakes. Fear of malpractice litigation and
the myth of perfect performance reinforce poor provider
communication of errors to patients and their families.
There is little doubt that the current malpractice crisis is
a deterrent to the openness required for quality improvement.6 However, errors not communicated to patients,
families, fellow staff members, and organizations are errors
that do not contribute to systems improvement.
Surveyors are instructed not to seek out specific sentinel
events beyond those already known to The Joint
Commission. The intent is to evaluate compliance with the
relevant Leadership and Performance Improvement requirements—that is, how the organization responds to sentinel
events when they occur. However, if a surveyor becomes
aware of a sentinel event while on site, he or she will take
the following steps:
1. Inform the CEO or the CEO’s designee that the event
has been identified.
2. Inform the CEO or the CEO’s designee that the event
will be reported to the Joint Commission Sentinel
Event Unit for further review and follow up under the
provisions of the Sentinel Event Policy.
Disclosing mistakes to patients and their families is difficult
at best. Yet legal and ethical experts generally advise practitioners to disclose mistakes to patients and their families in
as open, honest, and forthright a manner as possible. One
suggestion is that physicians have an ethical duty to disclose
errors when the adverse event does one of the following7:
• Has a perceptible effect on the patient that was not
discussed in advance as a known risk
• Necessitates a change in the patient’s care
• Potentially poses an important risk to the patient’s
future health
• Involves providing a treatment or procedure without the
patient’s consent
During the on-site survey, the surveyor(s) will assess the
organization’s compliance with sentinel event–related standards in the following ways:
• Review the organization’s process for responding to a
sentinel event.
• Interview the organization’s leaders and staff about
This idea maintains that disclosure of a mistake may foster
learning by compelling the physician to acknowledge it
truthfully and that the physician-patient relationship can be
enhanced by honesty.8 Disclosing a mistake might even
reduce the risk of litigation if the patient appreciates the
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CHAPTER 2
| Addressing Sentinel Events in Policy and Strategy
Figure 2-9. Disclosure Checklist
Complete?
Part I – Initial Disclosure Conversation
Y
N
N/A
Comments
Within 60 minutes after the Communication and
Optimal Resolution (CANDOR) event is identified,
advise the patient and/or family that an adverse
event may have occurred.
Tell the patient/family that the organization will
conduct an event investigation and analysis to
understand what happened and will share the
results.
Affirm that the first priority is to take care of the
patient and meet their health care, social, and
emotional needs.
Ensure that the family is treated compassionately
and provided with the necessary resources to
help support their needs.
Designate an organizational contact person the
patient and family can reach with questions or
concerns.
Activate the Care for the Caregiver support
system to provide support for staff who were
involved in the event.
Complete?
Part II – Initial Disclosure Conversation
Y
N
N/A
Comments
Get Ready
Review the event with team members, as
applicable, so that you are familiar with
relevant information.
Discuss the goal for the disclosure conversation
with other team members that might be involved
in the communication.
Strongly consider including one or more team
members in the disclosure with the patient to help
debrief, remember, and document the discussion.
Anticipate the patient's emotional response, and
plan how you will respond empathetically.
Consider whether a surrogate/family member
should be present.
Anticipate likely questions from the patient/family.
Rehearse (in person or by phone) the discussion
with another CANDOR Disclosure Lead.
Recognize that this is likely to be one in a
series of discussions with the patient/family
about the event.
Consider your own feelings and seek support,
as needed.
43
continued
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 2-9. Disclosure Checklist continued
Set the Stage
Turn off/sign out beepers and phones, if possible
(or silence, if not possible).
Find a quiet, private area for the conversation.
Sit down.
Describe the purpose of the conversation.
Listen and Empathize Throughout
Assess the patient's/family's understanding of
what happened.
Identify the patient's/family's key concerns.
Actively listen to the patient.
Acknowledge and validate the patient's feelings.
Explain the Facts
What happened?
Identify the adverse event early in the disclosure.
Explain what happened in a way that is easy to
understand.
Explain what is known about why the adverse
event occurred; do not speculate.
Tell the patient whether the adverse event was
preventable, if known.
Explain your role in the event to the patient/
family; avoid blaming others or "the system" for
the event.
What are the potential consequences?
Tell the patient/family what will be done now
to care for the patient and how the event may
impact his/her long-term health care.
Tell the patient/family what the organization is
committed to doing to mitigate the impact on the
patient's long-term health.
Apologize
Say you are sorry for the adverse event in a
sincere manner early in the conversation.
If the Event Was Preventable (Due to Error)
Tell the patient/family what should have
happened.
Tell the patient/family what will be done differently
to prevent a similar event from happening to
another patient, or that a plan will be developed
to this effect.
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CHAPTER 2
| Addressing Sentinel Events in Policy and Strategy
Figure 2-9. Disclosure Checklist continued
Close the Discussion
Discuss next steps and plan for a
follow-up conversation.
Ask if there are any final questions and provide
responses; if unable to answer, promise to follow
up with the answers.
After the Conversation
Debrief the conversation with colleagues who
were present and the CANDOR Disclosure Lead.
Review key elements of discussion, and establish
consensus about what was said and next steps.
Discuss what went well and what could be done
going forward to enhance communication.
Document the disclosure conversation in the
medical record, including only the facts of the
conversation and follow-up plans. If you are not
certain what to document, contact a CANDOR
Disclosure Lead or risk manager.
Consider ways to involve patients in
post-event learning.
Key Disclosure Communication Skills
Show empathy
►► ALLOW the patient to express his/her emotions.
►► ACKNOWLEDGE the patient’s emotions.
►► VALIDATE the patient’s emotions by saying that his/her response is understandable.
Be honest
►► EXPLAIN the facts about the adverse event without the patient having to do a lot of probing.
►► GIVE direct answers to the patient’s questions.
If you do not know the answer to the patient’s questions, state this directly and explain your plan to learn
more and keep him/her updated.
Utilize effective communication strategies
►► SHOW sincere interest in the patient’s questions and concerns.
►► USE good nonverbal expression (for example, eye contact).
►► AVOID medical jargon.
►► CHECK for the patient’s understanding of the information throughout the conversation.
►► BE yourself!
This checklist is adapted from The Agency for Healthcare Research and Quality. Its purpose is to prepare health care
organization leadership and staff for disclosing information to patients, their families, and any family surrogates after a
sentinel event occurrence. Part I should be used within an hour of identifying a Communication and Optimal Resolution
(CANDOR) event. Part II is available to assist in follow-up exchanges between parties.
Source: Disclosure Checklist. Content last reviewed February 2017. Agency for Healthcare Research and Quality, Rockville, MD. Accessed Jul 13, 2017.
http://www.ahrq.gov/professionals/quality-patient-safety/patient-safety-resources/resources/candor/module5-checklist.html
45
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
References
their expectations and responsibilities for identifying,
reporting, and responding to sentinel events.
• Ask for and review an example of a root cause analysis
that has been conducted in the past year to assess the
adequacy of the organization’s process for responding
to a sentinel event. Additional examples may be
reviewed if needed to more fully assess the organization’s
understanding of, and ability to conduct, root cause
analyses. In selecting an example, the organization may
choose a previous Joint Commission–reviewed root
cause analysis or a close call to demonstrate its process
for responding to a sentinel event.
1. Joint Commission International. Understanding and Preventing
Sentinel and Adverse Events in Your Health Care Organization.
Oak Brook, IL: Joint Commission Resources, 2008.
2. Croteau RJ. Sentinel events, root cause analysis and the trustee.
Trustee. 2003 Mar;56(3):33–34.
3. Perper JA. Life-threatening and fatal therapeutic misadventures.
In Bogner MS, editor: Human Error in Medicine. Hillsdale, NJ:
Lawrence Erlbaum Associates, 1994, 27–52.
4. Spath P. Avoid panic by planning for sentinel events. Hosp Peer
Rev. 1998 Jun;23(6):112–117.
5. Keyes C. Responding to an adverse event. Forum. 1997
Apr;18(1):2–3.
6. Blumenthal D. Making medical errors into “medical treasures.”
JAMA. 1994 Dec 21;272(23):1867–1868.
Surveyors also review the effectiveness and sustainability
of organization improvements in systems and processes in
response to sentinel events previously evaluated under The
Joint Commission’s Sentinel Event Policy.
7. Cantor MD, et al. Disclosing adverse events to patients. Jt Comm
J Qual Patient Saf. 2005 Jan;31(1):5–12.
8. Wu AW, McPhee SJ. Education and training: Needs and
approaches for handling mistakes in medical training. Paper
presented at the Examining Errors in Health Care Conference,
Rancho Mirage, CA, Oct 13–15, 1996.
Onward with Root Cause Analysis
Having developed and implemented a sentinel event policy,
the organization is now ready to start performing root
cause analyses and developing corrective action plans. The
next four chapters describe step-by-step how to perform a
root cause analysis and develop, implement, and assess an
improvement-driven corrective action plan.
9. Witman A, Hardin S. Patients’ responses to physicians’ mistakes.
Forum. 1997 Apr;18(1):4–5.
10. Agency for Healthcare Research and Quality, Rockville, MD.
Accessed Jul 13, 2017. http://www.ahrq.gov/professionals
/quality-patient-safety/patient-safety-resources/resources/candor
/module5-checklist.html.
46
CHAPTER
3
Preparing for Root Cause Analysis
Learning Objectives
Root Cause Analysis: Step-by-Step
• Prepare for root cause analysis by recruiting
and organizing a team and identifying roles and
responsibilities for each member
STEP 1:
55
STEP 2:
55
STEP 3:
55
• Identify and define the problem to be investigated,
including identifying the systems involved
STEP 4:
STEP 5:
• Learn about the various types of evidence to be
collected and how they may be used to illuminate
the problem
STEP 6:
STEP 7:
STEP 8:
STEP 9:
Now suppose an organization has experienced a sentinel
event or a close call. Staff have informed leadership and,
in the case of an actual sentinel event, the organization
has completed preliminary response procedures, including
ensuring patient safety, risk containment, and preservation
of evidence (as described in Chapter 2). The appropriate
staff members have documented the event and ensured
communication with appropriate stakeholders. What
happens next?
STEP 10:
STEP 11:
STEP 12:
STEP 13:
STEP 14:
STEP 15:
STEP 16:
This chapter explains how to prepare for a root cause
analysis. It covers strategies for organizing a team, defining
the problem, and studying the problem. This includes
examining potential situations such as suicide, elopement,
treatment delay, and medication error. A description of each
of these sentinel events appears in Sidebar 3-1, page 48.
Checklists appear throughout the chapter. A fuller discussion of the tools mentioned at each step of the root cause
analysis process is provided in Chapter 7.
STEP 17:
STEP 18:
STEP 19:
STEP 20:
STEP 21:
Organize a Team
Define the Problem
Study the Problem
Determine What Happened
Identify Contributing Process Factors
Identify Other Contributing Factors
Measure—Collect and Assess Data
on Proximate and Underlying Causes
Design and Implement
Immediate Changes
Identify Which Systems Are Involved—
The Root Causes
Prune the List of Root Causes
Confirm Root Causes and Consider
Their Interrelationships
Explore and Identify Risk-Reduction
Strategies
Formulate Improvement Actions
Evaluate Proposed
Improvement Actions
Design Improvements
Ensure Acceptability of the Corrective
Action Plan
Implement the Improvement Plan
Develop Measures of Effectiveness
and Ensure Their Success
Evaluate Implementation of
Improvement Efforts
Take Additional Action
Communicate the Results
A series of steps comprise the root cause analysis process.
These are listed in the box, above. The process begins
with the selection of a multidisciplinary team, defining the
problem, and then studying it.
47
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
STEP 1: Organize a Team
incident is still fresh in their minds and then examine
the data they have collected to identify obvious
follow-up questions.
The first step involved in conducting a root cause analysis is
to convene a team to assess the sentinel event or potential
sentinel event. After the event occurs, leadership should
immediately organize the team involved to prevent the
delay of the root cause analysis process. The team should
collect information from all the relevant parties while the
The assembled team and work groups should create a
detailed work plan. The work plan must include target
dates for accomplishing specific objectives. Target dates help
Sidebar 3-1. Sentinel Event Examples
Suicide
A 20-year-old male patient is admitted for observation
to the behavioral health care unit of a general hospital.
He has a well-documented history of depression. On his
second day in the unit, he attends a particularly clamorous
group session. Following the session, between 10:00 a.m.
and 11:00 a.m., he commits suicide in his bathroom by
hanging himself with bedding sheets from the showerhead. A registered nurse finds him at 11:05 a.m., calls a
code, and starts unsuccessful resuscitation efforts.
Several weeks later, the woman calls the physician’s
office again, noting that she can feel a hard lump in her
breast and mentioning that it hurts. The physician tells
her to come into the office right away. Upon review of her
record, the physician finds the results and orders another
mammogram with needle localization right away. The test
reveals a change in the size of a nodule from a previous
mammogram. This result requires an immediate biopsy,
which is positive. Subsequent surgery reveals that the
cancer has metastasized.
Elopement
Nursing staff in a long term care facility note that an
80-year-old woman with a history of progressive dementia
is unusually irritable and restless. She is pacing, talking in
a loud voice, and complaining about a number of issues.
The nurses on duty are unable to appease her or to determine the cause of her distress. Staff members frequently
remind the woman to move away from the exit door. In the
evening, staff members discover that the woman is no
longer on the unit nor in the building. The woman left the
facility without warm clothing on during a cold evening with
subzero temperatures. She is found dead the following
morning in a wooded area near the facility. Cause of death
was exposure.
Medication Error
A 60-year-old male patient receiving home care services
complains about a headache to his home health nurse
on each of the nurse’s three visits during a one-week
period. The man indicates that he is tired of “bothering” his
primary care physician about various symptoms. At the
conclusion of the third visit, the nurse offers to discuss
the man’s complaint with his primary care physician upon
return to the agency.
When the nurse discusses the headache with the man’s
physician, the physician instructs the nurse to call the local
pharmacy with the following prescription: “Fioricet Tabs.
#30 Sig: 1-2 tabs q 4-6 hours prn headache Refill x3.” In
error, the nurse telephones the pharmacy and provides
the following prescription: “Fiorinal Tabs. #30 Sig: 1-2 tabs
q 4-6 hours prn headache Refill x3.” The man has a long
history of peptic ulcer disease, which resulted in several
hospitalizations for gastrointestinal bleeding.
Treatment Delay
A 60-year-old female patient goes to an ambulatory health
care organization to receive her annual physical from her
longtime physician. The physician orders a mammogram,
which she schedules for two weeks later. A week after the
mammogram, a nurse in the physician’s office calls the
woman and informs her that additional mammogram
views are required but does not convey any sense of
urgency and then files the x-ray reports in the woman’s
medical record rather than in the proper file for tests
requiring follow-up. When the woman calls the physician’s
office to ascertain whether the repeat mammogram has
been ordered, another office employee tells the woman
not to worry about it if she did not get a call from the
physician directly.
The man takes the Fiorinal, which contains 325 milligrams
of aspirin per tablet. In contrast, the intended medication—Fioricet—contains 325 milligrams of acetaminophen
per tablet. The man completes the entire first prescription
and 15 tablets of the first refill. At this point, he goes to the
emergency department with acute abdominal pain, blood
in the stool, and a hemoglobin count of 4.9. He is immediately admitted to the intensive care unit. Within hours, he
needs life support. After several units of blood and a fourweek hospital stay, the man recovers and is able to return
to his home.
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CHAPTER 3
guide the analysis process and provide a structured game
plan for the team moving forward.1
| Preparing for Root Cause Analysis
ongoing purpose, a team generally meets for shorter
periods to address a specific issue. After a particular project
is completed, the team often disbands—with a sense of
accomplishment.
Team leaders sometimes may experience difficulty when
trying to keep team members focused. A study reported
in the Australian Health Review found that team leaders
can struggle to maintain focus primarily because teams
lack an understanding of the root cause analysis process.
Another significant challenge for team leaders in the
study was organizing a team within seven days after the
incident occurred.2
Why Use a Team?
A team approach brings increased creativity, knowledge,
and experience to solving a problem. Just as a patient’s care
is provided by a team, the analysis of that care should be
carried out by a team that includes representatives of all the
professional disciplines involved. Multidisciplinary teams
distribute leadership and decision making to all levels of an
organization. Teams in health care organizations provide
a powerful way to integrate services across the continuum
of care.3 They also provide successful strategies to effect
systemwide improvement.
Leaders must lay the groundwork by creating an environment conducive to root cause analysis and improvement
through team initiatives. Often, leaders need to assure staff
that the objective of the process is to improve the organization and identify and reduce risks, rather than assign blame
for the incident. Staff may experience guilt, remorse, fear,
and anxiety following the occurrence of a sentinel event.
Leaders must address and discuss these emotions at the
earliest stages of team formation. Putting staff members at
ease will enable them to contribute to risk reduction. The
team will collaborate to recommend changes, and leadership will provide the necessary resources (including time to
do the work). This partnership results in a defined structure and process for moving forward. While developing a
team and selecting team members, ensure that the elements
shown in Checklist 3-1, below, are present in the organization’s leadership.
Who Should Work on the Team?
The core of an appropriate team may already exist in the
form of a targeted performance improvement team representing relevant disciplines or services. The selection of
team members is critical. The team should include staff
members at all levels closest to the issues involved—those
with fundamental knowledge of the particular process
involved. These individuals will likely gain the most from
improvement initiatives. If the organization has a quality
improvement department, it is helpful to include a representative from that department who was not directly
involved with the event to act as a facilitator.
The decision about whether to include the individual(s)
directly involved in the sentinel event can be made by the
organization on a case-by-case basis. For instance, if an
individual is emotionally traumatized by the event, it may
make sense to instead invite another person of the same
discipline with comparable process knowledge to join the
team. Later, during the action planning stage it may make
sense to bring the individual(s) directly involved with the
sentinel event onto the team to make a positive contribution to the system and process redesign. Team members
should bring to the table a diverse mix of knowledge bases,
excellent analytic skills, decision-making authority, and a
commitment to performance improvement. While drawing
up a tentative list of team members, check to ensure
that the team includes the individuals highlighted in
Checklist 3-2, page 50.
Checklist 3-1.
Essential Elements for
a Team Go-Ahead
33Awareness of and support from top leadership
33Leadership commitment to provide necessary
resources, including time
33An empowered team with authority and
responsibility to recommend and implement
process changes
What Is a Team?
The word team implies a group that is dynamic and
working together toward a well-defined goal. In the health
care environment, a team should be interdisciplinary.
Unlike committees that hold recurring meetings for an
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
leadership and areas or functions represented. Realistically,
the selection of all team members cannot take place until
leaders identify the broad aim of the improvement initiatives to be generated by the root cause analysis and corrective action plan.4
Checklist 3-2.
Team Composition
33Individuals closest to the event or issues involved
33Individuals critical to implementation of potential
changes
For example, to investigate the root cause of a medical gas
utility disruption that led to the death of a patient when
his oxygen supply was inadvertently cut off, the core team
should include individuals from multiple disciplines. These
might include physicians, representatives from clinical
staff (nursing and/or respiratory therapy), management,
administration, and information management; someone
who works primarily with medical gases and the utility
management program; and if vendors are a primary part of
the analysis, someone from the purchasing or contracting
services department.
33A leader with a broad knowledge base who is
respected and credible
33A person with decision-making authority
33Individuals with diverse knowledge bases
Participation
Physician participation on performance improvement teams
varies. Improvement initiatives resulting from root cause
analyses often address some aspect of clinical care. In such
cases, medical staff involvement is essential. However, at
times physician involvement is not essential (for example,
in a situation in which a pharmacy stocked an incorrect
drug in a medication drawer and a nurse administered the
drug without noticing the discrepancy). Leaders should
consider carefully whether a physician needs to be involved
in the case at hand. Leaders also must understand the
barriers to physician involvement and take steps to overcome those barriers. Factors might include skepticism about
the purpose of root cause analyses and improvement teams,
concerns about relevance and effectiveness of teams, and
lack of time and incentive to participate. In cases in which
physician participation is vital, leaders need to convince
physicians to take part.
The core team investigating several types of events are listed
in Sidebar 3-2, page 51.
The team should have a leader who is knowledgeable, interested, and skilled at group consensus building and applying
the tools of root cause analysis. This person guides the team
through the root cause analysis process while encouraging
open communication and broad participation. The leader
may function as a facilitator or may assign a separate team
member to play the facilitator role. This individual should
be skilled at being objective and moving the team along. It
is best if the leader and facilitator are not stakeholders in
the processes and systems being evaluated.
Be creative when considering possible team members.
Might a former patient, family member, or other community member be able to provide a unique perspective and
valuable input? For example, perhaps team members could
invite the town’s retired pharmacist or a former patient
who experienced a patient safety event to join the root
cause analysis team. If one of the suspected root causes of a
sentinel event relates to information management, perhaps
the team could invite a member of the local chapter of an
information management association or organization.
The leader should also identify ad hoc members who
can provide administrative support, additional insight,
and resources.
Ground Rules
At the first team meeting, the leader should establish
ground rules that will help the team avoid distractions
TIP
Team composition may need to change as the team moves
in and out of areas within the organization that affect or
are affected by the issues being analyzed. An organization should allow for and expect this change to happen.
However, the core team members should remain as stable
as possible throughout the process, at least in terms of
Core teams limited in size to no more than nine
individuals tend to perform with greater efficiency.
Experts needed at various points can be added
as ad hoc team members and attend only the
relevant meetings.
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| Preparing for Root Cause Analysis
Sidebar 3-2. Sample Root Cause Analysis Core Team Membership
The suicide in a behavioral health care unit might include
the following individuals:
►► Any staff member, such as a psychiatrist, who was
attending the patient at the time of the sentinel
event and can discuss the specific circumstances
of the event
►► The individual responsible for performance improve-
ment (facilitator of the group)
►► A social service worker
►► A unit activity staff member
The core team investigating the treatment delay in an
ambulatory health care organization might include the
following individuals:
►► A nurse from the behavioral health care unit
►► An occupational therapist, physical therapist, or recre-
ation therapist (who has clinical skills and knowledge
but would not necessarily spend much time on the
behavioral health care unit)
►► The director of the ambulatory health care organization
►► A staff physician
►► The medical director
►► A social worker on the unit
►► The appointments scheduler
►► A medical staff leader who understands processes and
has the authority to change medical staff policy
►► A staff nurse
►► The manager of the behavioral health care unit
►► The office manager
►► A representative from quality improvement or risk
►► The manager of the laboratory from which the results
management (who will act as the facilitator)
were delayed
►► An administrative representative at the level of vice
►► The director or manager of quality or
president (such as nursing, patient care, or an associate vice president) who can make changes
performance improvement
The core team investigating the medication error in
a home care organization might include the following
individuals:
►► A safety engineer
►► A safety consultant (on an ad hoc basis)
►► A home health nurse
The core team investigating the elopement of a
resident from a nursing care center might include the
following individuals:
►► A nursing supervisor
►► An agency director or administrator
►► The director of nursing
►► A member of the pharmacy supplier’s staff
►► A unit nurse (regular care provider)
►► A local pharmacist (on an ad hoc basis)
►► A nursing assistant (who regularly cared for
►► The medical director
the resident)
►► The quality or performance improvement coordinator
►► The medical director
►► An information technology or management staff
►► The safety director or person responsible for the
member, as available
safety program
and detours on the route to improvement. The following
ground rules provide a framework that will allow the team
to function smoothly:
• Team mission: The leader should establish the group’s
mission or focus as one of systems improvement rather
than individual fault finding.
• Sentinel event policy: The leader should provide
copies of the organization’s sentinel event policy and
procedures, enabling all team members to become
familiar with expectations.
• Decision making: The group must decide what kind
of consensus or majority is needed for a decision,
recognizing that decisions belong to the entire team.
• Attendance: Attendance is crucial. Constant late
arrivals and absences can sabotage the team’s efforts.
Set guidelines for attendance.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
• Meeting schedule: For high attendance and steady
progress, the team should agree on a regular time, day,
and place for meetings. They should revisit these matters
at various times during the team’s life.
• Time line: The leader should present a time line at the
initial meeting to keep the group on track as it moves
toward its quality improvement goals.
• Opportunity to speak: By agreeing at the outset to give
all members an opportunity to contribute and to be
heard with respect, the team will focus its attention on
the important area of open communication.
• Disagreements: The team must agree to disagree. It
must acknowledge and accept that members will openly
debate differences in viewpoint. Discussions may
overflow outside the meeting room, but members should
feel free to say in a meeting what they say in the hallway.
• Assignments: The team should agree to complete
assignments within the particular time limits so that
delayed work from an individual does not delay the
group.
• General rules: The team should discuss all other rules
that members believe are important. These rules can
include whether senior management staff can drop in;
how electronic devices such as cell phones, pagers, and
the like should be handled to minimize distraction; what
the break frequency should be; and so forth.
an honest, objective assessment of what actually happened.
Team members from the department where the sentinel
event occurred might be defensive about the incident and
try, consciously or otherwise, to minimize or cover up the
role of their department. Some team members also may try
to blame others for the incident in an attempt to deflect
possible criticism away from their coworkers.
See Checklist 3-3 for techniques team leaders or facilitators
can use to ensure high-quality group discussion.
A group leader must continually encourage team members
to talk honestly about the event and provide the details
Checklist 3-3.
Leadership Techniques for
Promoting High-Quality
Group Discussion
33Use small groups to report ideas.
33Offer quiet time for thinking.
33Ask each person to offer an idea before allowing
comments or second turns at speaking.
33Keep the discussion focused on observations rather
than opinions, evaluations, or judgments.
33Keep the discussion moving forward within the
allotted time frame.
33Pull the group together if the discussion fragments
into multiple conversations.
33Encourage input from quiet members.
33Seek consensus or group decisions.
How Can the Group Leader
Facilitate Discussions?
TIP
The goal of root cause analysis is to look at a sentinel or
patient safety event from many angles. However, teams
should complete their root cause analysis in a limited
amount of time. To expedite a root cause analysis, the
team may have to create smaller work groups and coordinate those efforts through detailed work plans and target
dates. For this reason, it is likely more important that a
team leader have expertise as a process facilitator than be an
expert in any particular clinical area. The goal of a leader is
to track all the “moving parts” of a root cause analysis and
collate the team’s findings into a coherent explanation and
corrective action plan.
To create a “no-blame” environment at meetings,
leaders should do the following:
►►Act as a role model by demonstrating a “let’s
learn from this” type of response when a mistake
is made.
►►Give an example of a mistake that the leader
personally has made to show that everyone
makes errors.
►►Provide examples or positive responses to errors
and some of the lessons learned from errors.
►►Thank staff members for speaking up and
offering suggestions.
►►Reward staff members for suggestions that are
shown to result in a measurable, positive impact.
When starting a root cause analysis, the biggest challenge
for a group leader often is ensuring that the team provides
►►Communicate directly and frequently.
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CHAPTER 3
necessary for an effective root cause analysis. An initial step
for the team is to emphasize and maintain the confidentiality of the team’s work. Some organizations require team
members to sign a confidentiality agreement stipulating
that information shared within the team is not transmitted
or disclosed outside of the team’s established communication mechanisms.5
| Preparing for Root Cause Analysis
the problem clearly, they can save time and effort and
avoid frustration.
Often, when using root cause analysis, the team will define
the problem as a single or sentinel event that caused death
or serious injury. However, the team can also use root
cause analysis to address a series of adverse events that do
not carry the significance of a sentinel event but do pose a
serious problem to the health care organization when taken
in aggregate.
Group leaders also can set the stage for open, honest discussions by being aware of group dynamics and keeping team
members focused on the task at hand. Group dynamic
issues that can detract a team from its goals include fear,
dominant personalities, lack of participation, the use of
blaming language, and predetermination of the correct
solutions or changes.
TIP
A well-defined problem statement describes what
is wrong and focuses on the outcome, not why the
outcome occurred.
The group leader should set the ground rules for discussion
and establish that certain behaviors will not be tolerated.
Do not tolerate the use of blaming language. Do not permit
one person or group to dominate the discussion. Group
leaders who establish confidentiality and reinforce the rules
of discussion will find that participation will increase over
time. Team members will feel reassured that the goal is to
address systems issues and not to blame individuals.
Whether the root cause analysis addresses a single incident
or a series of events, it should clearly define the problem.
In response to a sentinel event or a patient safety event, the
team might ask, “What actually happened or what alerted
the staff to a close call?” Initially the team can identify the
problem or event simply:
• Surgery was performed on the incorrect site.
• Patient committed suicide by hanging.
• Patient could have died following overdose of a drug.
• Abductor tried to leave the unit with an infant that did
not belong to him or her.
One way the group leader can help team members relax
and feel more comfortable about expressing themselves is
to start each meeting with an “icebreaker.” An icebreaker is
a tool that helps the group get to know each other and gets
the conversation going at the beginning of the meeting.
The icebreaker may be a brief game or puzzle or simply
having each person in turn answer a general, open-ended,
perhaps even whimsical question unrelated to the business
at hand, for example, “What was your favorite food when
you were a child?” or “If you could take a free vacation
anywhere in the world, where would you go?” A good
icebreaker sets a positive, inclusive tone for the meeting.
Pick one that works for you and your meeting participants.
These simple statements focus on what happened or the
outcome, not on why it happened. During later steps in
the root cause analysis process, the team will focus on the
sequence of events, on the whys, and on causal factors.
For close calls or improvement opportunities, the preceding
problem statements could be restated as follows:
• Surgery was almost performed on the incorrect site.
• Patient attempted to commit suicide by hanging.
• Patient almost received overdose of a drug.
• Abductor was discovered by a nurse before leaving
the unit.
STEP 2: Define the Problem
One of the first steps taken by the root cause analysis team
is to define the problem—that is, to describe, as accurately
as possible, what happened or what nearly happened. The
purpose of defining the problem as clearly and specifically as possible is to help focus the team’s analysis and
improvement efforts. If the team defines and understands
Particularly in the event of a close call, multiple causal
factors may exist. Each team needs to develop ranking
criteria to decide which factor to address first. One option
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
is to rank causal factors by their cost impact, organization
priority, consequence or severity, safety impact, or real or
potential hazard.6 Causal factors should be addressed one
at a time. The team should tackle the highest-ranked factor
and solve it before initiating work on lower-ranked factors.
(Chapter 6 will provide more information on this idea.)
For example, analysis teams frequently cite medication
ordering as a risk-prone system due to organization hierarchies. Nurses and pharmacists may be reluctant to question
physicians writing the orders. Some organization cultures
may create a hierarchical rather than team structure for
the entire medication use process. Similarly, verification
of surgical sites by surgical team members can suffer from
hierarchical pressures. Nurses may be reluctant to question
physicians. The hierarchical mind-set can affect everyday
scenarios as well, as in a situation in which a housekeeper
hesitates to question a respiratory therapist observed
touching patients without first performing hand hygiene.
Language barriers coupled with a hierarchical culture can
present a particularly problematic scenario.
Help with Problem Definition
The information disseminated from the Sentinel Event
Database of The Joint Commission can help an organization identify a problem or area for analysis. The purpose of
this database is to increase general knowledge about sentinel
events, their causes, and strategies for prevention. The Joint
Commission collects and analyzes data from the review
of actual sentinel events, root cause analyses, corrective
action plans, and follow-up activities in all types of health
care organizations. The goal of sharing lessons learned
with other health care organizations is to reduce the risk of
future sentinel events.
Identify High-Risk Processes
Most frequently, sentinel events result from multiple system
failures. They also frequently occur at the point at which
one system overlaps or hands off to another. An organization should be tracking high-risk, high-volume, and problem-prone processes as part of its performance improvement efforts. High-risk, high-volume, problem-prone areas
vary by organization and are integrally related to the care,
treatment, and services provided. For example, to reduce
the risk of infant abductions, a large maternity unit should
focus on its infant-parent identification process. To reduce
the risk of patient suicide, a behavioral health care unit
should focus on its process for suicide risk assessment.
Organizations can learn about sentinel events that occur
with significant frequency, their root causes, and possible
risk-reduction strategies through The Joint Commission’s
publication Sentinel Event Alert (see Sidebar 3-3, page 55)
and the official newsletter The Joint Commission Perspectives®
received by every accredited organization. Sentinel events
reported in the national media, such as the medication
error described in the Introduction, can also serve as a
source of ideas for problem analysis. All organizations can
use the areas or problems outlined here as a starting point
in identifying a problem area for analysis.
A first step to finding such processes includes the list of
frequently occurring sentinel events published by The
Joint Commission; an organization’s risk management
data, morbidity and mortality data, and performance data
(including sentinel event indicators and aggregate data
indicators); and information about problematic processes
generated by field-specific or professional organizations.
Identify Complex Systems
Identifying problem areas such as failure-prone systems
through root cause analysis requires focus. A number
of factors increase the risk of system failures, including
complexity—a high number of steps and handoffs in work
processes. Complex systems may be dynamic, with constant
change and tight time pressure and constraints. The tight
coupling of process steps can increase the risk of failure.
Tightly coupled systems or processes do not provide much
slack or the opportunity for recovery. Sequences do not
vary, and delays in one step throw off the entire process.
Variable input and nonstandardized process steps can
increase the risk of process failure. So can processes carried
out in a hierarchical rather than team structure.
Developing a Preliminary Work Plan and
Reporting Mechanism
After a team has defined the problem, it can develop a
preliminary work plan for investigating the sentinel event
through root cause analysis. The plan should outline the
overall strategy, key steps, individuals responsible for each
step, target dates, and reporting mechanisms. It is essential at this point to define the scope of the plan so team
members can provide a specific answer to the question,
“How will we know if we are successful?”
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| Preparing for Root Cause Analysis
Sidebar 3-3. Sentinel Event Alert
The following topics have been covered in the Joint Commission’s Sentinel Event Alert publication:
►► Inadequate hand-off communication (Sep 2017)
►► Tubing misconnections—a persistent and potentially
deadly occurrence (Apr 2006)
►► The essential role of leadership in developing a safety
culture (Mar 2017)
►► Using medication reconciliation to prevent errors
(Jan 2006)
►► Detecting and treating suicide ideation in all settings
(Feb 2016)
►► Preventing vincristine administration errors (Jul 2005)
►► Preventing falls and fall-related injuries in health care
►► Patient controlled analgesia by proxy (Dec 2004)
facilities (Sep 2015)
►► Preventing and managing the impact of anesthesia
awareness (Oct 2004)
►► Safe use of health information technology (Mar 2015)
►► Managing risk during transition to new ISO tubing
►► Revised guidance to help prevent kernicterus
connector standards (Aug 2014)
(Aug 2004)
►► Preventing infection from the misuse of vials
►► Preventing infant death and injury during delivery
(Jun 2014)
(Jul 2004)
►► Preventing unintended retained foreign objects
►► Preventing surgical fires (Jun 2003)
(Oct 2013)
►► Infection control–related sentinel events (Jan 2003)
►► Exposure to Creutzfeldt-Jakob disease (Sep 2013)
►► Bed rail–related entrapment deaths (Sep 2002)
►► Medical device alarm safety in hospitals (Apr 2013)
►► Delays in treatment (Jun 2002)
►► Safe use of opioids in hospitals (Aug 2012)
►► Preventing ventilator-related deaths and injuries
(Feb 2002)
►► Health care worker fatigue and patient safety
(Dec 2011)
►► Prevention of wrong-site surgery (Dec 2001, Aug 1998)
►► Radiation risks of diagnostic imaging (Sep 2011)
►► Medication errors related to potentially dangerous
abbreviations (Sep 2001)
►► A follow-up report on preventing suicide: Focus on
medical/surgical units and the emergency department
(Nov 2010)
►► Preventing needlestick and sharps injuries (Aug 2001)
►► Medical gas mix-ups (Jul 2001)
►► Preventing violence in the health care setting
(Jun 2010)
►► Exposure to Creutzfeldt-Jakob disease (Jun 2001)
►► Preventing maternal death (Jan 2010)
►► Look-alike, sound-alike drug names (May 2001)
►► Leadership committed to safety (Aug 2009)
►► Kernicterus threatens healthy newborns (Apr 2001)
►► Safely implementing health information and converging
►► Fires in the home care setting (Mar 2001)
technologies (Dec 2008)
►► Mix-up leads to a medication error (Feb 2001)
►► Preventing errors relating to commonly used
►► Infusion pumps (Nov 2000)
anticoagulants (Sep 2008)
►► Fatal falls (Jul 2000)
►► Behaviors that undermine a culture of safety (Jul 2008)
►► Making an impact on health care (Apr 2000)
►► Preventing pediatric medication errors (Apr 2008)
►► Operative and postoperative complications (Feb 2000)
►► Preventing accidents and injuries in the MRI suite
(Feb 2008)
Current and past issues of Sentinel Event Alert are posted
on The Joint Commission’s website at http://www
.jointcommission.org/sentinel_event.aspx.
►► Preventing adverse events caused by emergency
electrical power system failures (Sep 2006)
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Creating a detailed work plan is critical to the process and
will secure management support. The full work plan should
include target dates for major milestones and key activities
in the root cause analysis process. These dates can mirror
the steps of the root cause analysis and corrective action
plan itself, including the following tasks:
• Defining the event and identifying the proximate and
underlying causes
• Collecting and assessing data about proximate and
underlying causes
• Designing and implementing immediate changes
• Identifying the root causes
• Planning improvement
• Testing, implementing, and measuring the success
of improvements
Frequency of communication also varies according to
the actions required in the short term to prevent recurrence of the event. The team needs to weigh communication frequency against the speed with which information
emerges from the investigation. If information merges
rapidly, the team leader should identify the most productive timing for communication. A description of reporting
considerations for each of the sample root cause analysis
investigations follows.
The reporting mechanism for a suicide investigation should
ensure that the psychiatrist on the team provides his or
her colleagues with regular updates on the team’s progress
at clinical department meetings. Such updates prepare the
medical staff for recommended policy changes. Similarly,
at executive staff meetings, the vice president on the team
should provide the CEO, chief operating officer, and
other leaders with regular updates on the team’s progress.
Frequent communication will foster leadership acceptance
of future recommendations, particularly those involving
significant resources. Safety should appear as a standing
agenda item at board meetings as well.
For a sentinel event that meets the sentinel event definition
of The Joint Commission or Joint Commission
International, the root cause analysis must be completed
within 45 days of the sentinel event or becoming aware
of the event.
Figure 3-1, page 57, indicates the key steps to include in
a work plan for a root cause analysis and provides space to
track the milestones. Later chapters describe each activity in
more detail.
The reporting mechanism for the elopement investigation
should ensure that the safety director provides the facility
management and operations staff with regular updates on
the team’s progress. Such updates prepare the staff for any
recommended building alterations to enhance the safety of
the care environment.
A team’s outline of the reporting mechanism aims to ensure
that the right people receive the right information at the
right time. At the beginning of the process, the team leader
or facilitator should establish a means of communicating
team progress and findings to senior leadership. Keeping
senior leaders informed on a regular basis is critical to
management support of the root cause analysis initiative
and implementation of its recommendations. Although it is
difficult to provide guidelines on how a regular basis should
be defined because the time frame varies widely depending
on circumstances, communication with senior leaders
should increase in frequency with the following:
• Serious adverse outcomes
• Repeated patient safety events
• Events requiring solutions from multiple parts of
the organization
• Possible solutions requiring the investment of significant
amounts of money
• Media involvement in the case and its solutions
The reporting mechanism for the treatment delay investigation in an ambulatory health care organization should
ensure that the office manager keeps the physician or
medical director informed of the team’s progress on a
regular basis. This regular communication prepares the
medical director for any possible changes with respect to
staffing levels and staff orientation, training, and ongoing
competence assessment.
The reporting mechanism for the medication error investigation should ensure that the information technology
staff member keeps his or her colleagues informed of the
team’s progress. This information flow facilitates the smooth
integration of any new processes or technology that may
enhance safe medication ordering.
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| Preparing for Root Cause Analysis
Figure 3-1. Tracking Key Steps in Root Cause Analysis
Milestone
Completion Date
Organize a team
Define the problem
Choose area(s) for analysis
Develop a plan
Study the problem
Gather information
Determine what happened and why (proximate causes)
Identify process problem(s)
Determine which patient care processes are involved
Determine factors closest to the event
Extract measurement data
Identify root causes
Determine which systems are involved
Design and implement a corrective action plan for improvement
Identify risk-reduction strategies
Formulate actions for improvement (considering actions, measures, responsible party,
desired completion date, and so forth)
Consider the impact of the improvement action
Design improvements
Implement action plan
Measure effectiveness
Develop measures of effectiveness
Ensure success of measurement
Evaluate implementation efforts
Communicate results
Note: In preparing a root cause analysis in response to a sentinel event remember that
the analysis must be completed no more than 45 days after the event’s occurrence or
becoming aware of the event.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
STEP 3: Study the Problem
Early on, the team should consider the best way to record
information. Some methods are more suitable than others.
For example, audio recording or video recording an interview with someone closely involved with the event will
likely increase an individual’s defensiveness. Note taking is
a more effective and less threatening way to record interviews. Video recordings, drawings, and/or photographs are
effective media to record physical evidence. For instance, if
an organization experiences an accidental death in which an
individual served is strangled after slipping through guard
rails on a bed, a video image or photo of the bed with guard
rails in place provides evidence of the position of the bed
following the event. The team should not rely on anyone’s
memory. Instead, a collection of notes, audio recordings,
video recordings, photographs, and drawings ensures accuracy and thoroughness of information. Drawings can be
particularly helpful for events such as patient falls, in which
the team wants to get a sense of the layout of the room
The team is now ready to start studying the problem. Doing
so involves collecting information surrounding the event
or close calls. Time is of the essence because key facts can
be forgotten in a matter of days. The individual(s) closest
to the event or close call may have already collected some
information that the team can use as a starting point. Often
a written statement provided by individuals involved in the
event and prepared as near the time of the event as possible
can be useful throughout the root cause analysis process. At
times, the individual(s) closest to the event may withhold
critical information due to fear of blame. The team should
consider how to minimize such fear (see Sidebar 3-4, which
provides sample statements for enhancing comfort). It
may be necessary in some instances to obtain an individual’s written statement and then proceed without his or her
contribution in the early stages of the analysis.
Sidebar 3-4. Sample Strategies for Enhancing Comfort
When collecting information about a sentinel event or close call, health care leaders can use statements such as those
presented here to help the staff member(s) involved feel more comfortable about offering information:
►► “Our objective is to learn how to deliver better, safer
►► “We really don’t want to know what you did or what
care at our hospital. We’re not here to punish anyone.”
(Emphasizes learning from the event, not blaming or
punishing anyone.)
your coworkers did during this event because your
individual responses to the situation are not the thing
that matters to us. It’s the overall process that we
are looking at.” (States that the goal of the inquiry is
to look at organizational processes, not at individual
behaviors.)
►► “Last year, when nurses shared details on their medi-
cation administration practices, we found three areas
in which we could make process improvements. As
a result, our drug error rates dropped significantly.”
(Provides examples of mistakes made in the past, how
the organization learned from the mistakes, and how
patients benefited from the subsequent improvements.)
►► “Everyone has an opinion, and we truly value yours.
We realize that in our hectic day-to-day work lives, you
don’t always get a chance to share opinions. Well, here
is your chance: Tell us what needs to be changed.”
(Asks for suggestions on how processes can be
changed.)
►► “Please go ahead and talk freely about the incident.
We’re not interested in assigning blame, we’re only
interested in helping patients. Isn’t that really why we’re
all here in the first place?” (Encourages staff members
to speak freely without fear of retribution from management or peers.)
►► “You are the real expert. You’re on the front line, so
you know what really goes on when you are delivering
care. We’re trying to understand everything you go
through, so we truly want you to share your expertise.” (Reinforces the idea that frontline staff are the
only true process experts—they have the best knowledge and vantage point to help come up with effective
improvements.)
►► “We want to gather insight into what works and what
doesn’t work with our current processes. Therefore,
we are offering a $25 bookstore gift card to anyone
who can point to a process that needs improvement.”
(Rewards staff members for providing insight into
the event.)
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CHAPTER 3
where a fall occurred. These various methods of recording
information can all benefit the team’s progress.
| Preparing for Root Cause Analysis
are not—that is, those that are or are not capable of
breaking automatically in response to a predetermined
external force (for example, the weight of an individual).
• Information to be collected in an elopement
investigation might include an environment of care
inventory of unattended or unmonitored exits;
availability and functionality of wander-prevention
technology such as electric bracelets and wired exits;
data related to the thoroughness and frequency of
initial resident assessment and ongoing reassessment for
elopement risk; and information regarding how data
about individuals at risk for elopement are integrated
into initial and ongoing care plans.
• Information to be collected in a treatment delay
investigation might include data about how test results
are processed within the organization and how staff
members are trained in these processes initially and on a
continuing basis. Data related to competence assessment
testing and staffing levels would also be valuable.
• Information to be collected in a medication error
investigation might include data on how medication
orders are transmitted to local pharmacies and the
percentage of queries and errors due to illegible
physician handwriting, misinterpretation of physician
handwriting, telephone or verbal orders, and order
transcription. Data related to the frequency of nurse
communication about a new medication and patient
education efforts would also be valuable.
TIP
The following media can be used to record
information obtained during a root cause analysis:
►►Written or typed notes
►►Photographs or drawings
►►Audio recording
►►Video recording
It is important that the team obtain legal counsel
on how to protect the organization from being
required to disclose the information in a potential
lawsuit as well as the requirements for consent to
tape or film individuals. The facilitator should collect
all notes and materials to keep in the root cause
analysis file to maintain existing protections from
legal discovery.
In all cases, the team should seek guidance from the
organization’s legal counsel regarding protection of information from discovery through its inclusion in peer review
and other means. The team also should seek guidance
from the organization’s risk management department or
legal counsel along with representatives of the health
information management department concerning patient
confidentiality and the information collected during the
root cause analysis.
Although information or data collection occurs throughout
the root cause analysis process, the team may also want to
gather three key types of information at this early stage6:
Collecting a huge amount of data, much of it unrelated
in any way, can be unproductive and confusing. To focus
collection efforts, examine the problem statement and
collect data along potential lines of inquiry. The list of
questions in Sidebar 3-5, page 60, can provide guidance
for potential lines of inquiry. For example, if a problem
statement such as “Patient was given wrong medication”
suggests an equipment maintenance or human resources
problem, then collect data relevant to medication distribution systems, training, and so forth. A sampling of information that might be collected relevant to the suicide,
elopement, treatment delay, and medication error examples
described back in Sidebar 3-1, page 48, follows:
• Information to be collected in a suicide investigation
might include an environment of care inventory of all
fixtures in the behavioral health care units and data
on which fixtures are breakaway compliant and which
1. Witness statements and observations from those
closest to the event or close call as well as those
indirectly involved
2. Physical evidence related to the event or close call
3. Documentary evidence
The following sections will address each type of
information further.
Witness Statements and Observations
Interviews with staff members can provide a wealth of
information during a number of stages of root cause
analysis. Shortly after an event or close call, interviews with
staff members directly involved can probe for what
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
from each person, without the influence of others in the
room. However, additional group interviews afterward can
encourage greater interplay of ideas and reinforcement of
the process improvement message.
Sidebar 3-5.
Types of Open-Ended Questions
Open-ended questions ensure that the interviewee
provides more than a simple “yes” or “no” answer.
Conducting interviews is both an art and a science. Some
people do it well; some do not. The team should carefully
consider who is best suited to interview each subject and
the best possible timing and sequence of interviews to be
conducted. The goal of the interviews is to identify facts,
possible systemic causes, and improvement opportunities—
not to place blame. The team should identify all likely
interview candidates at each stage and be aware that people
tend to forget information or remember it incorrectly,
rationalize situations, and perceive situations differently.
Three types of open-ended questions that can be used
effectively to gain the depth and breadth of information
needed during interviews follow.
Exploratory Questions
Exploratory questions can be used effectively to begin
the discussion or move to a new topic. They encourage
the interviewee to provide both comprehensive and
in-depth information. Examples include the following:
►► “What can you tell me about . . . ?”
►► “What can you recall about . . . ?”
Four discrete stages of continuous interview process
are preparing for the interview, opening the interview,
conducting the interview, and closing the interview.
Consider the following descriptions7:
Follow-Up Questions
Often, it may be necessary to clarify or amplify information provided by the interviewee. Follow-up questions
can help. Examples include the following:
►► “What do you mean by . . . ?”
Preparing for the Interview
►► “Can you tell me more about . . . ?”
The interviewer plans the interview. Planning involves
reviewing previously collected information and developing
carefully worded interview questions that are open-ended.
Planning also includes scheduling the interview, determining how information will be recorded and documented,
preparing to answer questions that the interviewee is likely
to ask, identifying material that should be available as a
reference during the interview, and establishing the physical
setting. Carefully worded responses to such questions
as “Why do you want to talk with me?” and “What will
you do with the information I provide?” can go a long
way toward reducing the interviewee’s defensiveness,
and so can a neutral setting that ensures privacy and
discourages interruptions.
►► “What is . . . ?”
►► “How did this come about?”
Comment Questions
Comment questions (or statements) encourage elaboration and express interest while not sounding so much
like a question. Examples include the following:
►► “Could you please describe that further?”
►► “I would like to know more about that.”
Source: Adapted from Minnesota Department of Public Health. Root
Cause Analysis Toolkit. Apr 7, 2014. Accessed Mar 4, 2017. http://www
.health.state.mn.us/patientsafety/toolkit/.
Opening the Interview
happened or almost happened and why (proximate causes).
Interviews with staff members indirectly involved can
explore possible root causes. Later in the process, interviews
can provide insight into possible improvement initiatives
and implementation strategies. The team should try to
strike a balance between individual interviews and group
interviews. Individual interviews are important for
obtaining as accurate an account of the situation as possible
The interviewer should greet the interviewee, exchange
informal pleasantries, state the purpose of the interview,
and answer the interviewee’s questions. The goal is to
establish rapport, put the interviewee at ease, establish
credibility, and get the interviewee involved in the interview process as quickly as possible. The interviewer should
indicate at this stage the amount of time the interview is
expected to take.
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Conducting the Interview
| Preparing for Root Cause Analysis
analysis process and do not reflect any suspicion of the
information provided in initial interviews.
• Interviewees should be encouraged to contact the team
leader with any concerns or additional information.
The interviewer poses the open-ended questions developed
during the preparation stage. Open-ended questions elicit
information by encouraging more than a “yes” or “no”
response. Refer back to Sidebar 3-5 for examples of ways to
pose such questions and for examples of question types that
can help ensure the questions sound natural.
Group interviews can be more efficient than individual
interviews, but the interviewer also should consider and
weigh with care any disadvantages. Disadvantages include
dominance by more vocal members of the group and
the emergence of groupthink, which can stifle individual
accounts of an event.
A two-step probing technique, using an open-ended
exploratory question and then a follow-up question asking
“why,” can yield valuable information. For example, the
interviewer might first ask, “What can you tell me about
the administration of medication in the unit?” After the
interviewee responds, the interviewer might follow up
with, “Why do you think that is the case?” This technique
should be used judiciously and reserved for important
areas because its repetition could make the interviewee
feel “drilled.”
When in-person interviews are not possible, telephone
interviews can provide an alternative. However, the telephone has some serious limitations. It is much more difficult to establish and maintain rapport when eye contact is
not part of the interview, and, of course, nonverbal cues are
much harder to detect.
Throughout the interview, the interviewer should listen
well, avoid interrupting the interviewee, avoid talking excessively, ask purposeful questions, and summarize throughout
the interview to confirm a proper understanding of what
the interviewee relates. The interviewer should also be aware
of his or her own body language, as well as of the interviewee’s body language and other nonverbal cues.
Written responses from an observer to specific questions
raised by the team offer another alternative. However, this
method is less likely than either in-person or telephone
interviews to elicit in-depth information. A matter as
seemingly trivial as how much space is provided for answers
on the form can have a significant impact on the quantity
of information provided. In addition, when the observer
must put something in writing, his or her concern about
the privacy and confidentiality of the information may
increase defensive behavior, thereby preventing full disclosure and honesty.
Closing the Interview
The interviewer should check to ensure that he or she has
obtained all necessary information; ask the interviewee if
he or she has any questions or concerns; summarize the
complete interview to ensure that the information accurately reflects the interviewee’s words; and thank the interviewee, expressing appreciation for his or her time, honesty,
and assistance.
TIP
Overcome interviewee defensiveness by doing
the following:
►►Restate the focus and purpose of the interview
and reiterate that information obtained will be
used to help prevent future occurrences of an
adverse event rather than to assign blame.
After the interviewee leaves the interview area, the interviewer should document any further observations and identify follow-up items. The interviewer should communicate
conclusions and results to the root cause analysis team as
appropriate.
►►Send positive, supportive messages through
statements such as “What you have said is
so helpful” and “I understand, and you have
obviously given this a lot of good thought.”
Remember the following points when gathering information from caregivers8:
• The way questions are asked will affect people’s
memories and their willingness to help.
• Interviewers should inform interviewees that followup interviews are a normal part of the root cause
►►Gently ask about a defensive reaction and probe
why the interviewee feels threatened. (Take great
care here to ensure that this inquiry will not do
more harm than good.)
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Physical Evidence
All such evidence should be examined, secured, and labeled
appropriately by the team.
Interviews with personnel closest to the event can help
the team identify relevant physical evidence, including
equipment, materials, and devices. Preserving physical
evidence immediately following the event or close call can
be essential to understanding why an event occurred or
almost occurred. In many instances, individuals may take,
misplace, destroy, move, or alter physical evidence in some
way, inadvertently or even deliberately.
Documentary evidence varies considerably, based on the
actual sentinel event or possible sentinel event. Examples of
documentary evidence for various error types are shown in
Sidebar 3-6. This information is a starting place in considering the kind of documentary evidence needed for any
organization’s root cause analysis.
Literature Review
Physical evidence for a sentinel event involving a medication
error, for example, might include the drug vial, syringe,
prescription, IV drip, filter straws, and medication storage
area. Physical evidence for a suicide in a 24-hour care setting
might include breakaway bars and fixtures in the shower or
elsewhere, a window, a ceiling, and other sites. Physical
evidence for a wrong-site surgery might include the x-rays,
the operative arena, surgical instruments, and so forth.
At this point and throughout the root cause analysis, a thorough review of the professional literature is an important
component of the process. Literature searches can yield
helpful information about the event at hand and other
organizations’ experiences with a similar event. The literature can help identify possible root causes and improvement
strategies. Appropriate professional or industry associations
and societies can provide a good starting point in the review
process. The team can obtain a variety of information on
the subject. A review of other organizations’ practices and
experiences can help the team avoid mistakes and inspire
creative thinking. To investigate causes and improvement
strategies for the sample sentinel events shown previously in
Sidebar 3-1, page 48, team members might obtain information such as the below possibilities.
The evidence should be thoroughly inspected by a knowledgeable team member, ad hoc member, or consultant.
Perhaps equipment was not fully assembled or parts were
missing. Team members should document observations
from the inspection. They should label all physical evidence
with information on the source, location, date and time
collected, basic content, and name of the individual
collecting it and then secure it in a separate area, if feasible.
If not, such as with a large piece of equipment, team
members should tag the item to indicate that it failed and
that its use is prohibited, pending investigation results.
For a suicide event, the team might obtain policies,
procedures, and forms for suicide risk assessment from
other organizations. A team member might conduct an
online literature search to obtain protocols for suicide risk
­assessment from relevant professional journals.
Documentary Evidence
Documentary evidence includes all material in paper or
electronic format that is relevant to the event or close call. It
could include the following:
• Patient records, physician orders, medication profiles,
laboratory test results, and all other documents used to
record patient status and care
• Policies and procedures, correspondence, and meeting
minutes
• Human resources–related documents such as
performance evaluations, competence assessments, and
physician profiles
• Indicator data used to measure performance
• Maintenance information such as work orders,
equipment logs, instructions for use, vendor manuals,
and testing and inspection records
For an elopement event, the team might obtain resident
assessment policies, procedures, and forms from other long
term care organizations and specifically information related
to how they assess at-risk-for-elopement status. The facility
or safety manager might obtain information from other
organizations related to systems used to ensure appropriate
security in the environment of care, such as wanderprevention technology. Assessment protocols from relevant
professional journals might be helpful as well.
For a treatment delay event, the team might obtain policies,
procedures, and protocols for communicating abnormal
test findings from the professional literature and peer
ambulatory health care organizations. Training and
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| Preparing for Root Cause Analysis
Sidebar 3-6.
Sample Documentary Evidence
For a suicide, documentary evidence could include the following:
►► The patient’s history and physical condition on
►► An inventory of items in the patient’s possession on
admission
admission
►► Staff observation notes
►► The patient’s psychosocial assessment
►► Attendance logs for unit activities
►► All physician and nursing notes prior to the incident
►► Policies and procedures for patient observation
For a medication error involving the administration of the wrong medication and the subsequent death
of a patient, documentary evidence could include the following:
►► The patient’s medical record
►► Equipment procedure logs for mixing of solutions
►► Trending data on medication errors
►► The error report to the US Pharmacopeia and state
licensing agency (for Joint Commission customers)
or to the local, regional, or national agency (for Joint
Commission International customers)
►► Procedures for medication allergy interaction checking
►► Pharmacy lot number logs
►► Pharmacy recall procedure
►► Lab test results of drug samples
►► Maintenance logs for equipment repair
►► Interdepartmental and interorganizational memos or
reports regarding the event
►► Downtime logs for computer software
For a mechanical error involving the shutoff of oxygen and the subsequent death of a patient, documentary
evidence could include the following:
►► Procedures for informing patient care areas about
►► Documents related to the utility systems planning
downtime of mechanical or life-support systems
process
►► Construction and technical documents and drawings of
►► Management competence assessment programs
the medical gas distribution system
►► Technical staff training, retraining, and competence
assessment programs in utilities systems processes
►► Inspection, performance measurement, and testing poli-
cies and procedures
►► Incident and emergency reporting procedures
►► Policies and procedures for shutoff of utility systems
►► Maintenance procedures and logs
►► Utility system performance measurement data
References
competence assessment literature could also provide insight
for improvement strategies. Professional organizations
might be a source of information on criteria for calling
in additional specialists.
1. Joint Commission International. Understanding and Preventing
Sentinel and Adverse Events in Your Health Care Organization.
Oak Brook, IL: Joint Commission Resources, 2008.
2. Middleton S, Walker C, Chester R. Implementing root cause
analysis in an area health series: Views of the participants. Aust
Health Rev. 2005 Nov;29(4):422–428.
For a medication error event, the team might contact other
home care organizations to obtain information about the
policies and protocols used to ensure a safe medication use
process. An online literature review could provide improvement strategies recommended by other health care organizations following a sentinel event or close call.
3. Ogrinc GS, et al. Fundamentals of Health Care Improvement: A
Guide to Improving Your Patients’ Care, 2nd ed. Oak Brook, IL:
Joint Commission Resources, 2012.
4. Shaqdan K, et al. Root-cause analysis and health failure mode
and effect analysis: Two leading techniques in health care quality
assessment. J Am Coll Radiol. 2014 Jun;11(6):572–579.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
5. Hoffman C, et al. Canadian Root Cause Analysis Framework:
A Tool for Identifying and Addressing the Root Causes of Critical
Incidents in Healthcare. Edmonton, AB: Canadian Patient Safety
Institute, 2006.
7. Minnesota Department of Health. Root Cause Analysis Toolkit.
Accessed July 14, 2017. http://www.health.state.mn.us
/patientsafety/toolkit/.
8. Boyd M. A method for prioritizing interventions following root
cause analysis (RCA): Lessons from philosophy. J Eval Clin Pract.
2015 Jun;21(3):461–469.
6. Andersen B, Fagerhaug T, Beltz M. Root Cause Analysis and
Improvement in the Healthcare Sector: A Step-by-Step Guide.
Milwaukee: ASQ Quality Press, 2010.
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CHAPTER
4
Determining Proximate Causes
Learning Objectives
Root Cause Analysis: Step-by-Step
• Learn to identify contributing process factors
STEP 1:
• Identify what needs to be measured and learn to
apply a variety of effective measurements
STEP 2:
STEP 3:
• Explore the tools with which a team can search for
proximate or direct causes
STEP 4:
55
STEP 5:
55
STEP 6:
55
STEP 7:
55
Tools to Use
STEP 8:
55
The following tools will help a team determine
proximate causes:
STEP 9:
►► Affinity diagram (see Figure 7-1, page 114)
STEP 10:
►► Brainstorming (see Figure 7-2, page 115)
STEP 11:
►► Change analysis (see Figure 7-3, page 116)
STEP 12:
►► Fishbone diagram (see Figure 7-8, page 124)
►► Flowchart (see Figure 7-9, page 126)
STEP 13:
►► Gantt chart (see Figure 7-10, page 127)
STEP 14:
STEP 15:
STEP 16:
Prior to this point in the process, the team has created a
very simple, one-sentence definition of what happened or
could have happened and has begun studying the problem.
The next step involves creating a more detailed description
or definition of the event (see the Appendix for a sample
event description form).
STEP 17:
STEP 18:
STEP 19:
STEP 20:
STEP 21:
Organize a Team
Define the Problem
Study the Problem
Determine What Happened
Identify Contributing Process Factors
Identify Other Contributing Factors
Measure—Collect and Assess Data
on Proximate and Underlying Causes
Design and Implement
Immediate Changes
Identify Which Systems Are Involved—
The Root Causes
Prune the List of Root Causes
Confirm Root Causes and Consider
Their Interrelationships
Explore and Identify Risk-Reduction
Strategies
Formulate Improvement Actions
Evaluate Proposed
Improvement Actions
Design Improvements
Ensure Acceptability of the Corrective
Action Plan
Implement the Improvement Plan
Develop Measures of Effectiveness
and Ensure Their Success
Evaluate Implementation of
Improvement Efforts
Take Additional Action
Communicate the Results
A series of steps comprise the root cause analysis process.
These are listed in the box above. The process begins with
the selection of the multidisciplinary team.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
piece of information appears on the tool so the source can
be consulted if more information is needed.
The Joint Commission’s Framework for Root Cause
Analysis and Action Plan provides an example of
a comprehensive systematic analysis. Please see
the Appendix for the framework and its 24 analysis
questions. These questions are intended to provide a
template for analyzing an event and an aid in organizing
the steps and information in a root cause analysis.
In creating this more detailed definition of an event, team
members should stick to the known facts and not speculate,
prior to completing the root cause analysis, on what is not
yet known or why things happened. For example, perhaps
the team’s problem statement at this point reads,
“80-year-old female found in room beside her bed,
lying on floor, dead. Sentinel event occurred sometime
between 0200 and 0330, Thursday, March 4.” Did
the patient die because of a fall? Or did the patient
fall after or while dying? A root cause analysis will help
the team identify the cause of death. In this example,
relevant areas or services affected by the event might
include nursing (to investigate monitoring systems and
medication administration), biomedical (to investigate
the type of bed, alarm, and call light system), staffing
office (to investigate whether the type of staff—regular
or float—affected the event), education (to investigate
orientation and training provided to staff and patient),
pharmacy (to investigate patient medications), medical
staff protocols (to investigate medications ordered
for the patient), and policies and procedures (related
to fall risk assessment, interventions, patient education,
and so on).
STEP 4: Determine What Happened
This description provides the when, where, and how details
of the event. It should include a brief description of
the following:
• What happened?
• Where and when did the event occur (place, date, day of
week, and time)?
• What areas or services were affected?
For example, with a sentinel event involving a medication
error, a more detailed definition of the event might state,
“A 60-year-old man receiving home care services
complains about a headache to his home health nurse
on each of the nurse’s three visits during a one-week
period. The man indicates that he is tired of bothering
his primary care physician about various symptoms.
STEP 5: Identify Contributing
Process Factors
At the conclusion of the third visit, the nurse offers
to discuss the man’s complaint with his primary care
physician upon return to the agency. The discussion
results in the physician prescribing a medication. A
transcription error results in the patient receiving
Fiorinal, instead of Fioricet, which results in gastrointestinal bleeding, a trip to the emergency department,
and a four-week hospital stay. The prescription was
delivered on Friday, January 1, and the patient was
admitted to the hospital on Monday, January 4.”
Root cause analysis involves repeatedly asking “Why?” to
identify the underlying root causes of an event or possible
event. At this point, the team asks the first of a series of
“why” questions. The goal of the first “why” question is to
identify the proximate causes of the event. Proximate causes,
or direct causes, are the most apparent or immediate reasons
for an event. They involve factors closest to the origin of
an event, and they can generally be determined by asking,
“Why did the event happen?” (See Sidebar 4-1 for more on
asking “why?”)
The relevant areas for this sentinel event might be nursing,
medicine, home care, and pharmacy.
In most cases, identifying the proximate causes is simple; in
other cases, it might take some digging. For example, in the
case of the patient found dead by her bed, proximate causes
could include “failure to monitor patient,” “bed alarm not
working,” “call light not working,” “patient not properly
Developing a flowchart is often helpful to determine the
sequence of events. Such a tool can help the team retain
focus on seeking the facts of the event (see Figure 7-9, page
126, for a sample flowchart). Ensure that the source of each
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2. What are the steps and linkages between the steps in the
process (a) as designed, (b) as routinely performed, and
(c) as occurred with the sentinel event?
3. Which steps and linkages were involved in, or
contributed to, the event?
Sidebar 4-1.
The Five Whys
The Five Whys is a problem-solving technique that
helps users to get to the root cause of the problem
quickly without statistical analysis. Users commonly
apply this strategy at the beginning of a process
improvement project. However, it can be used at any
time to understand the root cause of any problem.
The team can use a variety of tools to attain a thorough
response to these questions. A flowchart is a useful way to
visualize the response to the questions “What are the steps
in the process?” and “What actually happens?” The team
can use brainstorming to identify processes and to confirm
that all relevant steps are included in the list of process
steps. Change analysis (see Figure 7-3, page 116) and
Fishbone diagrams (see Figure 7-8, page 124) are useful
techniques in analyzing a response to the question
“Which steps and linkages were involved in or contributed
to the event?”
It’s about asking the question “Why?” five times. Instead
of stopping at the symptom, users drill down to the
underlying cause. This technique focuses on finding the
vital root cause that is affecting the overall problem.
►► Begin with your team’s problem statement. Frame
the statement as a question.
Why was the medication dosage for
Patient X missed?
►► As a project team, ask the question “Why?” Reach
consensus on the answer the team would like to
start with. Write that answer down on a Post-It Note
or whiteboard.
The team can then probe further by asking three
more questions:
1. What is currently done to prevent failure at this step or
its link with the next step?
2. What is currently done to protect against a bad outcome
if there is failure at this step or linkage?
3. What other areas or services are affected?
Because Dr. Y was on the floor looking for an
update on Patient Z
►► Ask “Why?” for a second time. Come up with an
answer. Reach consensus and write the next answer
down.
Comparing the flowchart of the process as specified in
written policies and procedures to the flowcharts of the
process as routinely performed can alert the team to staff
actions that circumvent policies and procedure (knowingly
or unknowingly). Staff members who perform the processes
in question should routinely compare their actual actions
to the prescribed policies and procedures to detect any
discrepancies.
Why was Dr Y on the floor? Because he had
surgeries scheduled in the morning.
►► Continue asking “Why?” and documenting each
answer until the root cause to the original problem
has been identified.
This process may require asking the question “Why?”
more than five times.
STEP 6: Identify Other Contributing
oriented to use of call light,” “incorrect sedation dispensed,”
or “incorrect administration of sedation.”
Factors
In health care environments, proximate causes tend to fall
into a number of distinct categories beyond and in addition
to process factors. They include the following:
• Human factors
• Equipment factors
• Information-related factors
• Controllable or uncontrollable environmental factors
Underlying causes in the health care environment may relate
to the provision of care or to other processes. Hence, identification of the patient care processes or activities involved
in the sentinel event or potential sentinel event will help the
team identify contributing causes. At this point, asking and
answering the following three questions will assist the team:
1. Which processes were involved in the sentinel event or
close call?
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
To identify additional proximate causes of an event
involving human factors, the team might ask:
• What human factors contributed to the outcome?
• What information-related factors impacted the outcome?
• What factors directly affected the outcome?
• Were such factors within or truly beyond the
organization’s control?”
Identifying the proximate causes of a patient suicide, as
described in Chapter 3, might lead a team to conclude
the following:
• Human factors such as failure to follow policies on
precaution orders or failure to conduct appropriate staff
education or training
• Assessment process factors such as a faulty initial
assessment process that did not include identification of
a history of suicide attempts or an immediate psychiatric
consultation
• Process or human factors such as a faulty history and
physical assessment that did not identify patient suicide
risk factors
• Equipment factors such as a nonfunctional paging
system that delayed communication with the
patient’s physician
Finally, the team might ask, “Are there any other factors
that have directly influenced this outcome?” Table 4-1,
on page 69, identifies many of the common factors associated with failures related to equipment, environment,
information, staff/people, and others.
Communication-related errors often result in procedurerelated failures. The majority of these errors involve four
types of communication:
1. Communication of relevant patient information among
staff members
2. Communication between physicians and other
physicians or staff members
3. Communication between staff and the patient or family
4. Oral communication problems, such as incomplete
change-of-shift reports; problems with administration,
such as delayed reporting of hazardous conditions; and
electronic communication problems
Brainstorming to identify all possible or potential contributing causes may be a useful technique for teams at this
stage of the root cause analysis (see Figure 7-2, page 115,
for a sample list of contributing factors, developed during a
brainstorming session). Following traditional brainstorming
ground rules—such as not labeling anything a bad idea and
ensuring that team members do not express reactions or
provide commentary as ideas are expressed—is critical to
success. The focus must be on improving patient outcomes
rather than individual performance. The team can use
affinity diagrams to help sort or organize the causes or
potential causes into natural, related groupings (see Figure
7-1, page 114).
Two other common factors in procedure-related failures are
flawed processes and failure to follow a defined process. It is
important to distinguish between the two when analyzing
root causes and developing improvement actions.
While asking questions to uncover causes, the team leader
should keep team members focused on processes, not
people. One individual’s actions generally will not be a root
cause. The team must focus on the systems within which
people are operating. That is the level at which they will
find most root causes. By repeatedly asking “Why?” the
team can continue working until it feels it has exhausted
all possible questions and causes. The importance of this
stage cannot be overstated. It provides the initial substance
for the root cause analysis without which a team
cannot proceed.
A flawed process is a process that can become a root cause
of errors, even when people are following the process
correctly. When the team identifies a flawed process as the
cause of an error, they must analyze and change the process
to eliminate the possibility of more errors.
Failure to follow a defined process occurs when staff
members fail to follow an established process and cause an
error. When the team identifies failure to follow a defined
process as a factor, they must hold an inquiry as to why the
process wasn’t followed: Is it a bad policy or is it that staff
members are not informed about the policy? Does the
organization tolerate shortcuts?
After sorting and analyzing the cause list, the team may
start to determine which process or system each cause is
a part of and whether the cause is a special or common
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Table 4-1. Root Causes
Root Cause Types
Causal Factors / Root Cause Details
Environmental factors
• Noise, lighting, flooring condition, and so forth
• Space availability, design, locations, storage
• Maintenance, housekeeping
Equipment/device/supply/health care
IT factors
• Equipment, device, or product supplies problems or availability
• Health information technology issues such as display/interface issues
(including display of information), system interoperability
• Availability of information malfunction, incorrect selection, misconnection
• Labeling instructions missing
• Alarms silenced, disabled, overridden
Task/process factors
• Lack of process redundancies, interruptions, or lack of decision support
• Lack of error recovery
• Workflow inefficient or complex
Staff performance factors
• Fatigue, inattention, distraction, or workload
• Staff knowledge deficit or competency
• Criminal or intentionally unsafe act
Team factors
• Speaking up, disruptive behavior, lack of shared mental model
• Lack of empowerment
• Failure to engage patient
Management/ supervisory/ workforce factors •
•
•
•
•
Organizational culture/leadership
Disruptive or intimidating behaviors
Staff training
Appropriate rules/policies/procedure or lack thereof
Failure to provide appropriate staffing or correct a known problem
Failure to provide necessary information
• Organizational-level failure to correct a known problem and/or provide resource
support including staffing
• Workplace climate/institutional culture
• Leadership commitment to patient safety
Source: Adapted from the Department of Defense. Patient Safety Reporting System (PSR) Contributing Factors Cognitive Aid, Version 2.0. May 2013.
cause in that process or system. This process, described
fully in the next chapter, helps unearth systems-based root
causes. Table 4-1 lists categories or types of root causes and
provides examples of causal factors within the categories
that lead to process and system breakdowns.
Measurement is the process of collecting and aggregating
data. The process helps assess the level of performance,
determine whether improvement actions are necessary, and
ascertain whether improvement has occurred.
The team must begin gathering data as soon as possible
after the event occurs to prevent loss or alteration of the
data. Data from people are the most easily altered or
destroyed and need to be made a priority. Other forms
of data are more stable; however, the team needs to identify physical data quickly to prevent inadvertent loss
or destruction.
STEP 7: Measure—Collect and Assess
Data on Proximate and Underlying Causes
To get to the heart of uncovering root causes, the team
must explore in depth proximate and underlying causes.
This exploration involves measurement—collecting and
assessing relevant data. Although this exploration is
presented here as step 7, data collection and analysis initiatives may occur throughout root cause analysis and need
not be sequential or follow step 6 and precede step 8.
Purposes of Measurement
Organizations collect data to monitor the stability of
existing processes, identify opportunities for improvement,
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
identify changes that lead to improvement, and
maintain changes.
Sidebar 4-2.
Determining What to Measure
Baseline Data
When choosing what to measure, an organization
may wish to start by defining the broad processes or
systems most likely to underlie proximate causes. For
example, if a team is investigating a medication error
involving the process used to communicate an order to
the pharmacy and the process used by pharmacy staff
to check the dosage ordered, the team may decide to
measure the following for a defined period of time:
►► Time elapsed between when an order is written by
medical staff and when the pharmacy receives the
order by fax, pickup, phone, or e-mail
The first purpose of measurement is to provide a baseline
when little objective evidence exists about a process. For
example, a health care organization may want to learn more
about the current level of staff competence. A dementia
long term care or psychiatric special care unit may want to
know more about the effectiveness of the bed alarm systems
to prevent patient falls and elopement. Specific indicators
for a particular outcome or a particular step in a process
may be used by the organization for ongoing data collection. When assessed, these data can help management
and staff determine whether a process is ineffective and
needs more intensive analysis. Data about costs, including
costs of faulty or ineffective processes, may also be of
significant interest to leaders and can be part of ongoing
performance measurement.
►► Number of calls to prescribers for clarification of
an order
►► Time elapsed between when the dosage is checked
by pharmacy staff and when medication is dispensed
►► Time elapsed between when medication is
dispensed and when medication is administered
Additional Data
The second purpose of measurement is to gain more information about a process chosen for assessment and improvement. For example, a performance rate varies significantly
from the previous year, from shift to shift, or from the
statistical average. Records may indicate that the staff
members on duty during weekend hours do not complete
suicide risk assessments at intake. Or perhaps the data indicate that patient observations are incomplete or infrequent
when specific personnel are present. Perhaps patient assessment methods or other care planning factors are suspected
as root causes of a sentinel event. Such findings may cause
a health care organization to focus on a given process to
determine opportunities for improvement.
needs to establish a baseline performance rate and continue
to measure use. Staff can also use measurement to demonstrate that key processes (for example, the preparation and
administration of medications) are in control. When a
process has been stabilized at an acceptable level of performance, the unit may measure it periodically to verify
sustained improvement.
Choosing What to Measure
Choosing what to measure is absolutely critical at all stages
of root cause analysis—in probing for root causes and
in assessing whether a recommended change or action
represents an actual improvement (see Sidebar 4-2, above).
Measurement requires indicators that are stable, consistent,
understandable, easy to use, and reliable. Indicators, or
performance measures, are devices or tools for quantifying
the level of performance that actually occurs. They are valid
if they identify events that merit review, and they are reliable if they accurately and completely identify occurrences
(see Checklist 4-1, page 71).
The target for further study by the organization should be
time limited and can test a specific population, a specific
diagnosis, a specific service provided, or an organization
management issue. Detailed measurement is then necessary
to gather data about exactly how the process performs and
about factors affecting that performance (see Table A-4 in
the Appendix for an example of this type of measurement).
Process and Outcome Measures
Future Data
A process measure is an intermediate indicator of the success
of an intervention. An outcome measure is a specific,
measurable indicator of the end result of an action. For
example, monitoring the number of speeding tickets
A third purpose of measurement is to determine the
effectiveness of improvement actions. For example, a
nursing unit that begins to use a new piece of equipment
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trigger further investigation each time it occurs. Because
risk managers are very aware of such indicators, they can
ensure that each event is promptly evaluated to prevent
future occurrences.
Checklist 4-1.
Characteristics for Choosing an
Appropriate Indicator or Measure
33 Quantitative—It is expressed in units of
measurement.
Although sentinel event indicators are useful to ensure
patient safety, they are less useful than aggregate data
indicators in measuring the overall level of performance in
an organization. An aggregate data indicator quantifies a
process or outcome related to many cases. Unlike a sentinel
event, the events typically measured by an aggregate data
indicator may occur frequently. Aggregate data indicators
are divided into two groups: rate-based indicators and
continuous variable indicators.
33 Valid—It identifies events that merit review.
33 Reliable—It accurately and completely identifies
occurrences.
33 A measure of a process or outcome—It involves
a goal-directed series of activities or the results
of performance.
a person receives is a process measure of that person’s safety
as a driver. The number of car accidents that person has
is an outcome measure of how safe a driver that person
actually is.
Rate-Based Indicators
Rate-based indicators express the proportion of the number
of occurrences to the entire group within which the occurrence could take place, as in the following examples:
Outcome measures are often misleading in health care. For
example, a root cause analysis could be used to change a
process that theoretically led to a sentinel event. The organization can measure outcomes, and the sentinel event might
not occur again for many years. However, because sentinel
events occur only rarely, it is difficult to make a direct
correlation between the outcome measure and the change.
This is a limitation of the use of outcome measures to assess
the effectiveness of process changes intended to reduce
the incidence of rare events. For example, if a wrong-site
surgery typically occurs in each hospital only once every
four to five years, can a hospital that has gone without a
wrong-site surgery for several years claim that the root cause
analysis has led to improved outcomes?
Patients receiving cesarean sections
All patients who deliver
Total number of elopements
Patients at risk for elopement (wandering and confused)
Patients with central line catheter infections
All patients with central line access devices
Patient falls associated with adverse drug reactions
All patient falls
Examples of an outcome indicator are “catheter-associated sepsis for patients with a central venous access device”
or “percentage of patients at risk for falls who actually
experience falls while in the health care organization.” An
example of a process indicator is “patients older than 65
having medication monitoring for drugs that can decrease
renal function.”
The rate can also express a ratio comparing the occurrences
identified with a different but related phenomenon, as in
the following example:
Patients with central line infections
Central line days
Organizations may categorize indicators as measures of
process or outcome. They can also classify indicators as
single-event indicators and aggregate data indicators. A
special type of single-event, outcome indicator is a sentinel
event. A sentinel event indicator identifies an individual
event or phenomenon that is significant enough to
Continuous Variable Indicators
This type of aggregate data indicator measures performance
along a continuous scale. For example, a continuous variable indicator might show the precise weight in kilograms
of a patient receiving total parenteral nutrition (TPN). Or
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
it might record the number of written pharmacist recommendations accepted by the attending physicians. While
a rate-based indicator might relate the number of patients
approaching goal weights to the total number of patients on
TPN, a continuous variable indicator measures the patient’s
average weight change (that is, the patient’s weight one
month minus the patient’s weight the previous month).
Additional information on measurement, including how
to measure the effectiveness of improvement initiatives and
ensure the success of measurement, appears in Chapter 6.
STEP 8: Design and Implement
Immediate Changes
Even at this early stage, when the team has identified only
proximate causes, some quick or immediate fixes may be
appropriate. For example, in the case of an organization
that experiences the suicide of a patient who is not identified as being at risk for suicide, the organization could
immediately evaluate its current risk assessment tool to
learn whether it meets current standards of practice. The
organization could also address environment of care issues
such as nonbreakaway showerheads and bed linens.
Choosing what to measure is critical, and so is ensuring
that the data collected are appropriate to the desired
measurement. See Figure 4-1, below, for criteria that will
help the team ensure that the measure or indicator selected
is actually appropriate for monitoring performance. See
Checklist 4-2 on page 73 for key questions the team should
ask about measurement throughout the root cause analysis
process.
DOWNLOAD
Figure 4-1. Data Collection Evaluation Checklist
The Measure
Y
N
N/A
Comments
Y
N
N/A
Comments
Y
N
N/A
Comments
The measure can identify the events, patterns, or
trends of performance it was intended to identify.
The measure has a documented numerator and
has a denominator statement or description of the
population to which the measure is applicable.
The measure has defined data elements and
allowable values.
The measure can detect changes in performance
over time.
The measure allows for comparison over
time within the organization or between the
organization and other entities.
The Source
The data intended for collection are available.
The sources of the data and methods of collecting
the data are defined.
Results
Results can be reported in a way that is useful to
the organization and other interested parties.
This checklist includes criteria to help a root cause analysis team ensure the date collected are
appropriate for monitoring performance. You can use it to evaluate whether the data you collect are
appropriate to the desired measurement you desire. Answers to all questions should ideally be Y for
Yes (unless they aren’t applicable).
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CHAPTER 4
| Determining Proximate Causes
• Moving and securing malfunctioning equipment from
the area of care, treatment, or service
Checklist 4-2.
Key Questions About Measurement
33 What will be measured? (This defines what is
Immediate changes may also uncover additional causes that
were previously masked but are critical to the search for the
root cause(s). Immediate changes can be part of a performance improvement cycle to test process redesign before
implementing it organizationwide. For instance, an
organization may wish to test the use of new bathroom
hardware in one room before changing hardware
throughout the facility.
critical to determining root causes.)
33 Why will it be measured? (This verifies the criticality
of what will be measured.)
33 What can be gained from such measurement?
(This describes the incentives of measurement.)
33 Who will perform the measurement?
33 How frequent is the measuring?
33 How will the data be used when measurement
is completed?
In addition, the organization could evaluate the assessment
tool for suicide risk and the process used to check for
contraband, and it could then initiate meetings with the
medical staff to discuss revisions to requirements for
histories and physicals.
33 Is the measure or measurement reliable?
33 Is measurement a onetime event or a periodic or
continuous process?
33 What resources are needed for measurement?
What is available?
33 Do the measures consider dimensions
The organization could start conducting mandatory
in-service training for all staff on suicide risk assessment. It
also could place all patients with psychiatric or substance
abuse diagnoses on suicide precautions. In the case of an
organization that experienced a wrong-site surgery, the
organization could require a second staff member to observe
operating room team procedures to assess compliance with
the Universal Protocol for Preventing Wrong Site, Wrong
Procedure, Wrong Person Surgery™. Figure 4-2, page 74,
provides an example of a poster that can support staff
education on the Universal Protocol.
of performance?
Teams conducting root cause analysis need not wait
until they finish their analysis to start designing and
implementing changes. During the process of asking
“Why?” potential interventions emerge. Immediate
changes may not only be appropriate but necessary. Teams
may need to make these changes to reduce an immediate
risk such as the following:
• Repairing an unsecured window
• Removing an intoxicated employee from
the environment
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 4-2. Data Collection Evaluation Checklist
SpeakUP
TM
Conduct a pre-procedure verification process
Address missing information or discrepancies before starting the procedure.
• Verify the correct procedure, for the correct patient, at the correct site.
• When possible, involve the patient in the verification process.
• Identify the items that must be available for the procedure.
• Use a standardized list to verify the availability of items for the procedure. (It is not necessary to
document that the list was used for each patient.) At a minimum, these items include:
q relevant documentation
Examples: history and physical, signed consent form, preanesthesia assessment
q labeled diagnostic and radiology test results that are properly displayed
Examples: radiology images and scans, pathology reports, biopsy reports
q any required blood products, implants, devices, special equipment
• Match the items that are to be available in the procedure area to the patient.
Mark the procedure site
At a minimum, mark the site when there is more than one possible location for
the procedure and when performing the procedure in a different location could
harm the patient.
• For spinal procedures: Mark the general spinal region on the skin. Special intraoperative
imaging techniques may be used to locate and mark the exact vertebral level.
• Mark the site before the procedure is performed.
• If possible, involve the patient in the site marking process.
• The site is marked by a licensed independent practitioner who is ultimately accountable for
the procedure and will be present when the procedure is performed.
• In limited circumstances, site marking may be delegated to some medical residents,
physician assistants (P.A.), or advanced practice registered nurses (A.P.R.N.).
• Ultimately, the licensed independent practitioner is accountable for the procedure – even
when delegating site marking.
• The mark is unambiguous and is used consistently throughout the organization.
• The mark is made at or near the procedure site.
• The mark is sufficiently permanent to be visible after skin preparation and draping.
• Adhesive markers are not the sole means of marking the site.
• For patients who refuse site marking or when it is technically or anatomically impossible or
impractical to mark the site (see examples below): Use your organization’s written, alternative
process to ensure that the correct site is operated on. Examples of situations that involve
alternative processes:
q mucosal surfaces or perineum
q minimal access procedures treating a lateralized internal organ, whether
percutaneous or through a natural orifice
q teeth
q premature infants, for whom the mark may cause a permanent tattoo
Perform a time-out
The procedure is not started until all questions or concerns are resolved.
• Conduct a time-out immediately before starting the invasive procedure or making the incision.
• A designated member of the team starts the time-out.
The
Universal
Protocol
for Preventing Wrong Site,
Wrong Procedure, and
Wrong Person Surgery™
Guidance for health care professionals
• The time-out is standardized.
• The time-out involves the immediate members of the procedure team: the individual performing
the procedure, anesthesia providers, circulating nurse, operating room technician, and other
active participants who will be participating in the procedure from the beginning.
• All relevant members of the procedure team actively communicate during the time-out.
• During the time-out, the team members agree, at a minimum, on the following:
q correct patient identity
q correct site
q procedure to be done
• When the same patient has two or more procedures: If the person performing the
procedure changes, another time-out needs to be performed before starting each procedure.
• Document the completion of the time-out. The organization determines the amount and type
of documentation.
This document has been adapted from the full Universal Protocol. For specific requirements
of the Universal Protocol, see The Joint Commission standards.
You can support targeted staff and physician education following a sentinel event with visual
reminders, such as with this poster available on the Joint Commission’s website at https://www
.jointcommission.org/assets/1/18/UP_Poster1.PDF.
74
CHAPTER
Identifying Root Causes
Learning Objectives
Root Cause Analysis: Step-by-Step
• Identify which systems underlie the proximate
cause(s) of the event
STEP 1:
• Find the root causes within those systems that
contributed to the event
STEP 3:
STEP 2:
STEP 4:
• Consider how the root causes in different systems
relate to and affect each other
STEP 5:
STEP 6:
STEP 7:
STEP 8:
Tools to Use
STEP 9:
55
The following tools will help a team identify
root causes:
STEP 10:
55
STEP 11:
55
►► Change analysis (see Figure 7-3, page 116)
►► Fishbone diagram (see Figure 7-8, page 124)
STEP 12:
►► Flowchart (see Figure 7-9, page 126)
►► Gantt chart (see Figure 7-10, page 127)
STEP 13:
►► Histogram (see Figure 7-11, page 128)
STEP 14:
►► Multivoting (see Figure 7-12, page 129)
►► Pareto chart (see Figure 7-14, page 132)
STEP 15:
►► Relations diagram (see Figure 7-15, page 134)
STEP 16:
STEP 17:
STEP 18:
The analysis continues. At this point, the team has a
detailed description of the sentinel event or close call, a
description of the patient care processes involved, and a
list of proximate causes and other factors that might have
caused or contributed to the problem or could do so in
the future. The team has also started to collect data on
proximate causes.
STEP 19:
STEP 20:
STEP 21:
75
Organize a Team
Define the Problem
Study the Problem
Determine What Happened
Identify Contributing Process Factors
Identify Other Contributing Factors
Measure—Collect and Assess Data
on Proximate and Underlying Causes
Design and Implement
Immediate Changes
Identify Which Systems Are Involved—
The Root Causes
Prune the List of Root Causes
Confirm Root Causes and Consider
Their Interrelationships
Explore and Identify Risk-Reduction
Strategies
Formulate Improvement Actions
Evaluate Proposed
Improvement Actions
Design Improvements
Ensure Acceptability of the Corrective
Action Plan
Implement the Improvement Plan
Develop Measures of Effectiveness
and Ensure Their Success
Evaluate Implementation of
Improvement Efforts
Take Additional Action
Communicate the Results
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
For a special cause in a process, teams should search for
the common cause in the system of which the process is
a part. Keep asking, “Why did the special-cause variation
occur?” to identify one or more common-cause variations
in the supporting systems that may represent root causes.
The team should review the processes and subprocesses
that compose the system. This examination should include
a review of existing policies and procedures by the process
owners in comparison to the actual practice. The team will
need to evaluate variations for the extent of common-cause
variation and the presence of special-cause variation.
The Joint Commission’s Framework for Root Cause
Analysis and Action Plan provides an example of
a comprehensive systematic analysis. Please see
the Appendix for the framework and its 24 analysis
questions. These questions are intended to provide a
template for analyzing an event and an aid in organizing
the steps and information in a root cause analysis.
STEP 9: Identify Which Systems Are
Involved—The Root Causes
Now the team again asks, “Why did that proximate cause
happen? Which systems and processes underlie proximate
factors?” The goal of asking questions at this stage is to
identify the underlying causes for the proximate causes. For
example, in the case of the elderly patient found dead on
the floor by her bed, questions might include the following:
• Why was the patient not monitored for an hour to an
hour and a half?
• Why was a new graduate nurse assigned to this patient’s
care? Did the nurse have the assistance of ancillary staff?
• How much orientation had the nurse completed?
• Why was the patient given a sedative?
• Why was the call light not by the patient’s hand?
• Was the patient assessed to be at risk for falling?
• Were interventions established? If so, why were they
not done?
For example, a special cause emerges when one group of
surgeons and their assistants do not follow hospital procedures for hand hygiene, resulting in a sentinel event. This
special cause might be part of a common-cause variation
in a larger system: the hospital’s inconsistent education in
sterile techniques and hand washing.
A logical starting point in the team’s effort to determine
the systems involved with the sentinel event or close call is
listing and categorizing the possible causal factors. The team
can categorize common or root causes of a sentinel event
in a health care organization according to the important
functions or processes performed by the organization. They
include processes for the following:
TIP
As in all stages of the process, it is critical to keep the team
focused on searching for system or common-cause problems rather than focusing on human errors. Teams often
have trouble at this stage of the root cause analysis. The
tendency is to stop short after identifying proximate causes
and not to probe deeper. The probing must continue until
the team can no longer identify a reason underlying a cause.
The resulting cause, then, is a root cause.
Clarify all issues. The team must clearly define
the issues regarding the patient safety event and
ensure that team members share a common
understanding of the issues. No matter how
obvious the issues may seem, individual team
members may not understand them in the same
way. For example, a staff member may not
consider identification of the surgical site by all
operating room team members to be worth the
time involved. Or, if a patient suffers a burn during
surgery, surgical team members may not agree
about whether the burn could have been affected
by the proximity of the oxygen cannula to the
cautery or how the cannula was handled during the
cauterizing procedure. It’s critical that such issues
be resolved and defined.
Underlying causes may involve special-cause variation,
common-cause variation, or both. Being “special” or
“common” is not an inherent characteristic of the cause
itself. Rather, it describes the relationship of the cause to
a specific process or system. It is possible for the same
cause to be a special cause in one process and a common
cause in another.
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CHAPTER 5
•
•
•
•
Human resources
Information management
Environmental management
Leadership—embracing organization culture,
encouragement of communication, and clear
communication of priorities
| Identifying Root Causes
Asking concrete questions about each function listed above
can help team members reach the essence of the problem—
the systems that lie behind or beneath problematic
processes (see Table 5-1, below, for a breakdown of causal
factors). At this stage, the team can word questions in the
following form: “To what degree does . . . ?” Follow-up
questions for each could be “Can this be improved, and if
so, how?” See Sidebar 5-1, page 78, for a fuller itemization
of possible questions.
In addition, the team should consider factors beyond an
organization’s control as a separate category. However, it
needs to exercise caution in assigning factors to this
category. Although a causative factor may be beyond an
organization’s control, the protection of patients from
the effects of the uncontrollable factor is within the
organization’s control in most cases and should be addressed
as a risk-reduction strategy.
Other questions may emerge in the course of an analysis.
The team should fully consider all questions; they may
be used to probe for systems that underlie problematic
processes. One team investigating a patient suicide found
that systems involving human resources, information
management, and environmental management issues were
root causes of the sentinel event:
Table 5-1. Causal Factor Category List
Human Factors
•
•
•
•
•
•
•
•
•
•
•
•
Verbal communication: The spoken presentation or exchange of information
Written procedures and documents: The written presentation or exchange of information
Human-machine interface: The design of equipment used to communicate information from the plan to a person
Environmental conditions: The physical conditions of a work area
Work schedule: Factors that contribute to the ability of a worker to perform his or her assigned task in an effective manner
Work practices: Methods workers use to ensure safe and timely completion of tasks
Work organization and planning: The work-related tasks including planning, identifying the scope of, assigning responsible
individuals to, and scheduling the task to be performed
Supervisory methods: Techniques used to directly control work-related tasks; in particular, a method used to direct workers in
the accomplishment of tasks
Training and qualification: How a training program is developed and the process of presenting information on how a task is to
be performed prior to accomplishing the task
Change management: The process whereby the hardware or software associated with a particular operation, technique, or
system is modified
Resource management: The process whereby personnel and material are allocated for a particular task or objective
Managerial methods: An administrative technique used to control or direct work-related plan activities, which includes the
process whereby staff and material are allocated for a particular task objective
Equipment Factors
• Design configuration and analysis: The design layout of a system or subsystem needed to support plan operation
and maintenance
• Equipment condition: The failure mechanism of the equipment that is the physical cause of the failure
• Environmental conditions: The physical conditions of the equipment area
• Equipment specification, manufacture, and construction: The process that includes the manufacture and installation
of equipment in a plant
• Maintenance and testing: The process of maintaining components and systems in optimal condition
• Plant and system operation: The actual performance of the equipment or component when performing its intended function
External Factor
• External: Human or nonhuman influence outside the usual control of the company
Source: Adapted from Ammerman M. The Root Cause Analysis Handbook: A Simplified Approach to Identifying, Correcting, and Reporting Workplace Errors.
New York: Productivity Press, 1998.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Sidebar 5-1.
Probing Questions for Root Cause Analysis
Human Resources
Use the following questions to probe for underlying systems issues within problematic processes. Questions concerning
human resources issues may include the following:
►► To what degree were staff members involved in this
►► What are the plans for dealing with contingencies that
event properly qualified and currently competent for
their responsibilities? Can these qualifications be
improved, and if so, how?
tend to reduce effective staffing levels? Can these
plans be improved, and if so, how?
►► To what degree is staff performance in the operant
processes addressed? Can such staff performance be
improved, and if so, how?
►► How did actual staffing at the time of the event
compare with ideal levels? Can the staffing level be
improved, and if so, how?
►► How can orientation and in-service training
be improved?
Information Management
Questions concerning information management issues may include the following:
►► To what degree was all necessary information avail-
►► How adequate is the communication of information
able when needed in the case of this event? What are
the barriers to information availability and access? To
what degree is the information accurate, complete, and
unambiguous? Can these factors be improved, and if
so, how?
among participants? Can such communication be
improved, and if so, how?
Environmental Management
Questions concerning environmental management issues may include the following:
►► How appropriate is the physical environment for the
►► What emergency and failure-mode responses have
processes being carried out? Can it be improved, and
if so, how?
been planned and tested? Can these responses be
improved, and if so, how?
►► To what degree are systems in place to identify envi-
ronmental risks? Can these systems be improved, and
if so, how?
Leadership
Questions concerning leadership issues may include the following:
►► How conducive is the culture to risk identification
►► To what degree is the prevention of adverse outcomes
and reduction? Can this culture be improved, and if
so, how?
communicated as a high priority? How is such prevention communicated? Can this communication be
improved, and if so, how?
►► What are the barriers to communication of potential
risk factors? Can these barriers be reduced or eliminated, and if so, how?
Uncontrollable Factors
Questions concerning uncontrollable factors may include the following:
►► What can be done to protect against the effects of
uncontrollable factors?
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CHAPTER 5
• In the human resources area, the organization had not
adequately assessed age-specific staff competence, and
staff needed additional training in management of
suicidal patients.
• In the information management area, information
about the patient’s past admission was not available.
Communication delays resulted in failure to implement
appropriate preventive actions.
• In the environmental management area, the team
found that access to the appropriate unit for the patient
was denied.
| Identifying Root Causes
analyze each cause or factor using reasoning skills based on
logic. Asking two questions helps clarify whether each cause
or problem listed is actually a true root cause:
1. If we fix this problem, will the problem recur in the
future?
2. If this problem is a root cause, how does it explain what
happened or what could have happened?
Using three criteria to determine whether each cause is
a root cause or a contributing (or proximate) cause, the
following three questions may then be asked:
1. Is it likely that the problem would have occurred if the
cause had not been present?
2. Is the problem likely to recur due to the same causal
factor if the cause is corrected or eliminated?
3. Is it likely that similar conditions will recur if the cause is
corrected or eliminated?
Finding Multiple Causes
Patient safety events can be very complex and involve
multiple causes. Understanding causes is essential if the
organization is to create lasting improvements. Certain
tools can be particularly helpful in systematically looking
at an event to determine its causes. The tools are designed
to help root cause analysis team members understand
processes and factors that contribute to both good and
problematic performance. Groups can also use the tools to
study a process, without requiring a statistical background.
They may be used singly or in combination to show the
relationship between processes and factors, reach conclusions, and systematically analyze causes.
If the answer to each question is “no,” then the problem is
a root cause. If the answer to any of the questions is “yes,”
then the problem is a contributing/proximate cause. It
may be helpful to develop a checklist with these questions
built in. A sample checklist with the questions appears as
Figure 5-2, page 82.
STEP 11: Confirm Root Causes and
Consider Their Interrelationships
Fishbone diagrams are particularly helpful in categorizing
and visualizing multiple system or process problems that
have contributed to a sentinel event or close call. The standard categories coming off the main “spine” of the diagram
include people, procedures, equipment or materials, environment, and policies. Such categories as communication,
education, leadership, and culture may also be appropriate
(see Figure 7-8, page 124). Subcauses branch off each major
category. Figure 5-1, page 80, provides a handy way to help
ensure that the team has considered selected systems-based
issues.
The team will very likely identify more than one root cause
for a sentinel event or close call. Even in those very rare
instances when a sentinel event results from the intentional
act of an individual, more than one root cause is likely
(for example, personnel screening, communication, and so
forth). Sentinel events in industry tend to have two to four
root causes, and these root causes tend to be interrelated.
To date, The Joint Commission’s Sentinel Event Database
indicates four to six root causes identified by participating
TIP
Ammerman proposed a classification system for causal
factors that is geared more toward a manufacturing environment.1 It may be helpful to review this (see previous Table
5-1) and other classification systems to ensure that the team
has identified all possible causal factors.
Organizations that have conducted a root cause
analysis should consider having their findings
and process reviewed by objective sources. The
Joint Commission uses a criteria-based review
process to assess the quality of data derived from
a root cause analysis. The process assesses
the thoroughness and credibility of a root cause
analysis submitted to The Joint Commission.
STEP 10: Prune the List of Root Causes
The team’s list of causal factors may be lengthy. Regardless
of the list’s length or the technique used, the team should
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 5-1. Problematic Systems or Processes Checklist
DOWNLOAD
Human Resources Issues
Qualifications
Physicians
Staff
¨
¨
¨
Defined
Verified
Reviewed and updated on a
regular basis
¨
¨
¨
Agency staff
Defined
Verified
Reviewed and updated
on a regular basis
¨
¨
¨
Defined
Verified
Reviewed and updated
on a regular basis
Training
Physicians
Staff
¨
¨
¨
Adequacy of training program
content
Receipt of necessary training
Competence/proficiency testing
following training
¨
¨
¨
Agency staff
Adequacy of training program
content
Receipt of necessary training
Competence/proficiency testing
following training
¨
¨
¨
Adequacy of training program
content
Receipt of necessary training
Competence/proficiency testing
following training
Competence
Physicians
Staff
¨
¨
Initially verified
Reviewed and verified on a
regular basis
¨
¨
Agency staff
Initially verified
Reviewed and verified on a
regular basis
¨
¨
Initially verified
Reviewed and verified on a
regular basis
Administration
Supervision of staff
¨
¨
Adequate for new employees
Adequate for high-risk activities
Current staffing levels
¨
¨
Based on a reasonable patient
acuity measure
Based on reasonable
workloads
Information Management Issues
¨
¨
¨
¨
¨
Availability of information
Accuracy of information
Thoroughness of information
Clarity of information
Communication of information between relevant individuals/participants
80
Current scheduling practices
¨
¨
¨
Overtime expectations
Time for work activities
Time between shifts for shift
changes
CHAPTER 5
| Identifying Root Causes
Figure 5-1. Problematic Systems or Processes Checklist continued
Environmental Management Issues
Systems to identify environmental risks
Physical environment
¨
¨
¨
¨
¨
¨
¨
¨
¨
¨
¨
Appropriateness to processes being carried out
Lighting
Temperature control
Noise control
Quality control activities
Adequacy of procedures and techniques
Inspections
Planned, tested, and implemented emergency and
failure-mode responses
Size/design of space
Exposure to infection risks
Cleanliness
Leadership and Communication Issues
Data use
¨
¨
Use in decision making
Use to identify changes in
the internal and external
environments
Planning
¨
¨
For achievement of short-term
and long-term goals
To meet challenge of external
changes
Communication
¨
¨
¨
¨
¨
¨
Design of services and work
processes
¨
¨
¨
Creation of communication
channels
Performance improvement
Introduction of innovation
Staffing
¨
¨
Present, as appropriate
Appropriate method
Sufficient number and mix of staff members
Competent to perform job responsibilities
Understood
Timely
Adequate
Management of change
Use this divided checklist to identify and rank problematic systems or processes. Use
a 1 to indicate a problem that is a primary factor and a 2 to indicate a problem that is a
contributing factor.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 5-2. Evaluation Checklist for Differentiating Root and Contributing Causes
Cause #1: _________________________________
Y
N
N/A
Comments
Y
N
N/A
Comments
Y
N
N/A
Comments
Y
N
N/A
Comments
DOWNLOAD
Would the problem have occurred if this cause had not
been present?
Will the problem recur due to the same causal factor if this
cause is corrected or eliminated?
Will similar conditions recur if this cause is corrected
or eliminated?
Cause #2: _________________________________
Would the problem have occurred if this cause had not
been present?
Will the problem recur due to the same causal factor if this
cause is corrected or eliminated?
Will similar conditions recur if this cause is corrected
or eliminated?
Cause #3: _________________________________
Would the problem have occurred if this cause had not
been present?
Will the problem recur due to the same causal factor if this
cause is corrected or eliminated?
Will similar conditions recur if this cause is corrected or
eliminated?
Cause #4: _________________________________
Would the problem have occurred if this cause had not
been present?
Will the problem recur due to the same causal factor if this
cause is corrected or eliminated?
Will similar conditions recur if this cause is corrected or
eliminated?
This checklist includes questions to ask about each cause identified by a root cause analysis team. You can use it to
differentiate root causes from contributing causes. If the answer is “no” to each of the three questions, the cause is a
root cause. If the answer is “yes” to any one of the three questions, the cause is a contributing cause.
organizations for each sentinel event. Examples of root
causes identified for various types of sentinel events are
provided in Table 5-2, page 83.
interaction of the root causes is likely to be at the root of
the problem. If an organization eliminates only one root
cause, it has reduced the likelihood of that one very specific
adverse outcome occurring again. But if the organization
misses two other root causes, it is possible that those root
causes could interact in another way to cause a different but
equally adverse outcome.
Although this information may provide insight into areas
to explore, organizations should not rely exclusively on
these lists but should work to uncover their own unique
root causes.
The root causes collectively represent latent conditions—
conditions that exist as a consequence of management and
organizational processes and that can be identified and
The identification of all root causes is essential to
preventing a failure or close call. Why? Because the
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CHAPTER 5
Table 5-2. Sample Root Causes Identified in the
Sentinel Event Database
corrected before they contribute to mishaps. The combination of root causes sets the stage for sentinel events.
Effective identification of all root causes and an understanding of their interaction can aid organizations in
changing processes to eliminate a whole family of risks, not
just a single risk.
Organizations that experienced the following types of sentinel
events reviewed by The Joint Commission identified, among
others, the root causes listed below.
Unintended Retention of a Foreign Object
•
•
•
•
•
•
The absence of policies and procedures
Failure to comply with existing policies and procedures
Problems with hierarchy and intimidation
Failure in communication with physicians
Failure of staff to communicate relevant patient information
Inadequate or incomplete education of staff
If a team identifies more than four root causes, a number
of the causes may be defined too specifically. In this case,
the team may wish to determine whether one or more of
the root causes could logically be combined with another to
reflect more basic, system-oriented causes. The team then
should verify each of the remaining root causes. Doing so
involves cross-checking for accuracy and consistency all
facts, tools, and techniques used to analyze information.
Any inconsistencies and discrepancies should be resolved.
Wrong-Patient, Wrong-Site, Wrong-Procedure
•
•
•
•
•
•
Miscommunication by operating room teams
Insufficient orientation and training of staff
Lack of procedural compliance
Lack of available information
Distraction
Leadership issues
How does an organization know whether and when it has
identified all true root causes of a sentinel event?
Patient Falls
•
•
•
•
•
| Identifying Root Causes
Insufficient staff orientation and training
Inadequate caregiver communication
Inadequate assessment and reassessment
Unsafe environment of care
Inadequate care planning and provision
Most root cause analysis teams ultimately reach a point
where they ask themselves, “When can we stop asking
‘Why?’” This question is best answered by considering
whether an identified cause is actionable in a way that will
likely prevent recurrences or otherwise protect patients
from recurrences. If the answer is “yes,” then it might be
acceptable to stop there, but it is by no means necessary to
stop there. Even root causes can have deeper root causes—
they usually do.
Suicides in a 24-Hour Care Setting
• The environment of care, such as the presence of
nonbreakaway bars, rods, or safety rails; lack of testing of
breakaway hardware; and inadequate security
• Patient assessment methods, such as incomplete
suicide risk assessment at intake, absent or incomplete
reassessment, and incomplete examination of patients (for
example, failure to identify contraband)
• Staff-related factors, such as insufficient orientation or
training, incomplete competency review or credentialing,
and inadequate staffing levels
• Communication issues and information-related factors,
such as incomplete communication among caregivers and
information being unavailable when needed
Organizations often struggle to identify root causes because
they are reluctant to confront sensitive, politically charged
issues such as organizational culture, resources, pressure
to produce or to move patients quickly through surgery,
and lack of leadership or support. Employees typically are
reluctant to address the problems they perceive because
they fear that their candor could cause repercussions within
the organization. As a result, for root cause analysis to
be successful, it must be a confidential and nonpunitive
process. There must also be timely, relevant feedback to
personnel reporting the adverse events to help them see that
their input is meaningful.2
Treatment Delays
•
•
•
•
Inadequate communication among caregivers
Insufficient patient assessment
Continuum of care issues
Staff-related factors, such as insufficient orientation
and training and insufficient competency and
credentialing processes
• Inadequate availability of information
Health care employees often struggle with the root cause
analysis process because it requires them to scrutinize not
only one another but also one another’s errors. A recent
study of root cause analysis meetings found that even when
Source: The Joint Commission. Sentinel Event Data: General Information
2Q 2016 Update, Most Commonly Reviewed Sentinel Event Types,
Accessed Jul 16, 2017. https://www.jointcommission.org/assets/1/18/Event
_type_2Q_2016.pdf. (This is the latest date for which this information is
publicly available.)
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
the analysis focused on close-call situations that did not
result in death, staff members were extremely wary about
how they positioned themselves in relation to the issues and
staff involved. The “talk” of root cause analysis work is
difficult in all situations.3
References
A team should report its root cause findings to the leaders
of its organization. Leaders must be informed, as should
the individuals likely to be affected by changes emerging
from the findings, during the next stage of the root
cause analysis. Chapter 6 provides information on
communicating the results of the team’s efforts.
3. Iedema RA, et al. Turning the medical gaze in upon itself: Root
cause analysis and the investigation of clinical error. Soc Sci Med.
2006 Apr;62(7):1605–1615.
1. Ammerman M. The Root Cause Analysis Handbook: A Simplified
Approach to Identifying, Correcting, and Reporting Workplace Errors.
New York: Productivity Press, 1998.
2. Stecker MS. Root cause analysis. J Vasc Interv Radiol. 2007
Jan;18(1 Pt 1):5–8.
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CHAPTER
6
Designing and Implementing a Corrective
Action Plan for Improvement
Learning Objectives
Root Cause Analysis: Step-by-Step
• Identify risk-reduction strategies
STEP 1:
• Set priorities and objectives for improvement in
areas identified as at the root of the problem
STEP 2:
STEP 3:
• Develop, test, implement, and measure the
effectiveness of improvement efforts
STEP 4:
STEP 5:
STEP 6:
STEP 7:
Tools to Use
STEP 8:
The following tools will help a team identify,
implement, and monitor improvement
opportunities:
STEP 9:
►► Affinity diagram (see Figure 7-1, page 114)
STEP 11:
STEP 10:
►► Brainstorming (see Figure 7-2, page 115)
STEP 12:
55
►► Change management (see Figure 7-4, page 117)
►► Failure mode and effects analysis (see Figure
7-7, page 122)
STEP 13:
55
STEP 14:
55
►► Flowchart (see Figure 7-9, page 126)
►► Gantt chart (see Figure 7-10, page 127)
STEP 15:
55
STEP 16:
55
►► Histogram (see Figure 7-11, page 128)
►► Multivoting (see Figure 7-12, page 129)
STEP 17:
55
STEP 18:
55
►► Operational definition (see Figure 7-13,
page 130)
►► Pareto chart (see Figure 7-14, page 132)
STEP 19:
55
►► Relations diagram (see Figure 7-15, page 134)
►► Run chart (see Figure 7-16, page 135)
STEP 20:
55
STEP 21:
55
►► Scatter diagram (see Figure 7-17, page 137)
►► SIPOC process map (see Figure 7-18, page 138)
►► Stakeholder analysis (see Figure 7-19,
page 140)
Organize a Team
Define the Problem
Study the Problem
Determine What Happened
Identify Contributing Process Factors
Identify Other Contributing Factors
Measure—Collect and Assess Data
on Proximate and Underlying Causes
Design and Implement
Immediate Changes
Identify Which Systems Are Involved—
The Root Causes
Prune the List of Root Causes
Confirm Root Causes and Consider
Their Interrelationships
Explore and Identify Risk-Reduction
Strategies
Formulate Improvement Actions
Evaluate Proposed
Improvement Actions
Design Improvements
Ensure Acceptability of the Corrective
Action Plan
Implement the Improvement Plan
Develop Measures of Effectiveness
and Ensure Their Success
Evaluate Implementation of
Improvement Efforts
Take Additional Action
Communicate the Results
The team asks, “So what are we going to do with the problematic systems now that we have identified them?” When
the team has a solid hypothesis about one or more root
causes, the next step is to explore and identify risk-reduction
strategies to help ensure that system flaws are corrected.
►► Standard work (see Figure 7-20, page 142)
►► Value stream mapping (see Figure 7-21,
page 144)
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
for individuals to make mistakes. By compensating for
less-than-perfect human performance, engineering systems
achieve a high degree of reliability through process
standardization, backup systems, and designed redundancy.
A failure rate as low as even 1% is not tolerated. The
emphasis is on systems rather than individuals.
The Joint Commission’s Framework for Root Cause
Analysis and Action Plan provides an example of
a comprehensive systematic analysis. Please see
the Appendix for the framework and its 24 analysis
questions. These questions are intended to provide a
template for analyzing an event and an aid in organizing
the steps and information in a root cause analysis.
Taking Safety to the Next Level
As noted elsewhere in this book, reliability in some other
complex industries, such as aviation and nuclear power,
substantially exceeds that in health care. What lessons can
these industries teach health care professionals that could be
adapted to the health care system in order to move organizations toward high reliability?
STEP 12: Explore and Identify
Risk-Reduction Strategies
Organizations that have root cause analysis experience
should consider conducting data analysis of multiple root
cause analyses. Sentinel and adverse events are not isolated
occurrences—organizations have often identified the
underlying root causes in past root cause analyses as
contributing or root causes of other, similar occurrences.
They often will find, through root cause analysis, dissimilar
events can have certain root causes in common. This kind
of convergence to common root causes by separate root
cause analyses of dissimilar events is a good demonstration
that root cause analyses are delving deeply enough.
The questions root cause analysis teams need to ask
are the following:
• What have we done before?
• What worked?
• What didn’t work? Why not?
• Why are we continuing to have this type of event?
After a team is ready to move forward with a risk-reduction
strategy, it must start by exploring relevant literature on
risk-reduction and error-prevention strategies. Much has
been written by experts in the field about the engineering
approach to failure prevention and how it differs from the
medical approach. Some of the literature’s key points are
described below.
Lucian L. Leape, MD, is a pioneer in comparing riskreduction approaches in various other industries to those
in the health care industry. He suggests four safety design
characteristics from the aviation industry that could, with
some modification, prove useful in improving safety in the
health care industry1:
• Built-in multiple buffers, automation, and redundancy.
Instrumentation in airplane cockpits includes multiple
and purposely redundant monitoring instruments.
The design systems assume that errors and failures are
inevitable and should be absorbed.
• Standardized procedures. Protocols that must be followed
exist for operating and maintaining airplanes.
• A highly developed and rigidly enforced training,
examination, and certification process. Pilots take
proficiency exams every six months.
• Institutionalized safety. The airline industry reports
directly to two agencies that regulate all aspects of flying,
prescribe safety procedures, and investigate all accidents.
A confidential safety reporting system established by
the Aviation Safety Reporting System operated by
the National Aeronautics and Space Administration
enables pilots, controllers, or others to report dangerous
situations, including errors they have made, to a third
party without penalty. This program greatly increases
error reporting in aviation, resulting in enhanced
communication and prompt problem solving.
The pervasive view of errors in the engineering field is that
humans err frequently and that the cause of an error is
often beyond the individual’s control. In designing systems
and processes, engineers begin with the premise that
anything can go wrong—and will. (Recall the Swiss cheese
model discussed in Chapter 1.) Their role is a proactive one:
to design accordingly. Because engineering-based industries
do not expect individuals to perform flawlessly, they
incorporate forcing functions into their designs—that is,
they try to design systems that make it extremely difficult
Organizations planning risk-reduction strategies should
consider three levels of design to reduce the risk of harm
to patients:
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| Designing and Implementing a Corrective Action Plan for Improvement
1. Design the process to minimize the risk of a failure.
2. Design the process to minimize the risk that a failure
will reach the patient.
3. Design the process to mitigate the effects of a failure that
reaches the patient.
patient needs is an essential principle of modern medicine;
variation to meet individual health care organization or
practitioner preferences need not be. Standardization will
get better overall results more safely—even if each practitioner might individually get better results than the others
by using a personally favored but different process than
others. Practitioners do not work alone within health care
organizations; they are members of teams, and those teams
interact with other teams. Thus, assuming each personally
favored practice is a good practice, it matters less which
process is selected as the basis for standardization than that
the process is performed consistently for safety.
These levels are similar to the epidemiological concepts
of degrees of disease prevention, which can be defined
as follows2:
• Primordial prevention: minimizes hazards to health.
• 1° prevention: reduces the risk of disease.
• 2° prevention: reduces the prevalence of disease.
• 3° prevention: reduces the impact of complications.
A Systems Approach to Risk Reduction
Risk-reduction strategies must emphasize a systems
rather than an individual human approach. A system
can be thought of as any collection of components and
the relationships between them, whether the components
are human or not, when the components have been
brought together for a well-defined goal or purpose.3
As Leape writes, “Creating a safe process, whether it
be flying an airplane, running a hospital, or performing
cardiac surgery, requires attention to methods of error
reduction at each stage of system development: design,
construction, maintenance, allocation of resources, training,
and development of operational procedures.”1(p. 1854) If errors
are made, if deficiencies are discovered, individuals at each
stage must revisit previous decisions and redesign or
reorganize the process.
A consideration for the first level of design might be
ensuring a positive interlock between tubes in a ventilator airflow circuit that might prevent a failure such as an
inadvertent disconnection of the tubes. Next, a consideration for the second level of design might be ensuring that
there is an airway pressure alarm that can detect a pressure
drop due to a tubing disconnection and alert staff before a
patient is harmed. Finally, a consideration for the third level
of design is the ready availability of resuscitation equipment
that can mitigate the effect of oxygen deprivation due to a
prolonged tubing disconnection.
It is also critical that error-prevention strategies used include
standardizing tasks and processes to minimize reliance on
weak aspects of cognition, testing professional performance,
and institutionalizing safety through close call and nonpunitive reporting. For example, clinical practice can design
guidelines, organization policies, and protocols to reduce
inappropriate variation in patient care and help reduce the
likelihood of failures. In a general sense, the consistency
with which a process is carried out (or standardized)
diminishes the tendency for a process failure. However, in
recent years practitioners have met with limited enthusiasm
attempts to standardize health care processes, such as
through the introduction of practice parameters, protocols,
clinical pathways, and so forth. Such processes are only
slowly affecting the actual delivery of care.
Designing for safety means making it difficult for humans
to err. However, organizations that design systems must
recognize that failures do occur and build recovery or
correction into the system. If that is not possible, individuals will need to detect failures promptly so they have
time to take corrective actions. For example, as required by
The Joint Commission’s Universal Protocol for Preventing
Wrong Site, Wrong Procedure, Wrong Person Surgery™,
medical staff must use a preprocedure verification process.
For example, they could use a checklist to confirm appropriate documents (such as medical records and imaging
studies) are available. The Universal Protocol also states that
the procedure site must be marked. Ideally, the marking
takes place with the patient involved, awake, and aware, if
possible. Finally, a time-out is performed immediately prior
to starting the procedure so the medical team can confirm
the correct patient, site, positioning, and procedure and, as
Achieving process consistency while recognizing and
accommodating variation in the process (for example, the
patient’s severity of illness, comorbidities, other treatments,
and preferences) is one of the major challenges to health
care standardization. Process variation to meet individual
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applicable, verify that all relevant documents, related information, and necessary equipment are available.
Fail-safe design is also a concept familiar to high reliability
industries, including aerospace and nuclear engineering.
The design may be fail-passive, fail-operational, or failactive. For example, a circuit breaker is a fail-passive device
that opens when a dangerous situation occurs, thereby
making an electrical system safe. A destruct system on a
satellite or an air-to-air missile is an example of a fail-active
device. If the satellite or missile misses its target within a set
time, the destruct system blows the satellite or missile apart
to halt its flight and limit any damage it might cause by
falling to the ground. Checklist 6-1, below, provides the key
risk-reduction strategies suggested in the medical and
engineering literature.
Organizations must eliminate risk points—specific points
in a process that are susceptible to failure or system breakdown—through design or redesign efforts. They generally
result from a flaw in the initial design of the process or
system, a high degree of dependence on communication,
nonstandardized processes or systems, and/or failure or
absence of backup.
For example, risk points during the medication use
process include interpretation of an illegible order by a
pharmacist and the time during which a registered nurse
mixes the medication dose to administer to a patient. In
surgical procedures requiring the use of lasers, a risk
point occurs during the use of anesthetic gases: The high
concentration of oxygen, if not properly synchronized
with use of the laser, can allow tubes, drapes, and
other potentially flammable materials to ignite. During
preoperative procedures, verification of the body side and
site constitutes a risk point.
Risk points and risk-reduction strategies for wrong site
surgery, suicide, and infant abductions or release to wrong
families are also provided in Sidebar 6-1. Not all these
strategies are specific Joint Commission requirements,
but they are presented for consideration by all health
care organizations.
Root Cause Analysis in Proactive
Risk Assessment
Built-in buffers and redundancy, task and process simplification and standardization, and training are all appropriate
design mechanisms to reduce the likelihood of failure at
risk points and elsewhere. For example, prior to the administration of medications, staff can perform multiple and
redundant checks such as asking the patient his or her name
and checking the patient’s armband to confirm that a medication is given to the right patient. See Sidebar 6-1, on page
89, for risk points for medication errors and risk-reduction
strategies to prevent such failures.
Expanding the use of risk assessment has emerged as a
strong trend in health care. Facilities can implement a
Systems engineering literature includes numerous other
design concepts that could be useful tools to prevent
failures and sentinel events in health care organizations.
Redundancy is one such concept familiar to the aerospace
and nuclear power industries, where systems have backups
and even the backups normally have backups.
Organizations can increase system reliability by introducing
redundancy into system design. However, the cost of
designing in redundancy is an issue in most health care
environments. The engineering literature also describes
the benefits of simplification, standardization, and
loose coupling to reduce the possibility of
systems-related problems.
33 Design systems that make the safest thing to do
Checklist 6-1.
Identifying Risk-Reduction
Strategies
33 Use an engineering (proactive, systems-based)
approach to failure prevention.
33 Start with the premise that anything can and will
go wrong.
the easiest thing to do.
33 Design systems that make it difficult for individuals
to err.
33 Build in as much redundancy as possible.
33 Use fail-safe design whenever possible.
33 Simplify and standardize procedures.
33 Automate procedures.
33 Ensure rigidly enforced training and competence
assessment processes.
33 Ensure nonpunitive reporting of close calls.
33 Eliminate risk points.
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Sidebar 6-1.
Risk Points and Risk-Reduction Strategies
for Various Sentinel Events
Medication Errors
Risk points
►► Training/education
►► Medication storage and access
►► Competence (lapses in performance, failure to comply
►► Labeling
with policies and procedures)
►► Nomenclature
►► Supervision
►► Dosage calculation
►► Staffing (excessive workload, incorrect mix)
►► Equipment
►► Communication
►► Abbreviations
►► Distraction due to environmental issues
►► Handwriting
►► Information availability
Risk-reduction strategies
To reduce the likelihood of failures associated with prescribing errors:
►► Implement a system of computerized order entry by
►► Redefine the role of pharmacists to enable them to
physicians (to decrease the likelihood of dosage error,
prompt for allergies, and provide information on drug–
drug and drug–food interactions).
perform daily rounds with physicians, work with registered nurses, and serve as on-site resources.
To reduce the likelihood of failures associated with dispensing:
►► Do not rely on color coding.
►► Support questioning of unclear orders.
►► Remove or separate look-alike/sound-alike medications.
►► Eliminate guessing.
►► Use bar coding if possible.
►► To reduce the likelihood of failures associated with
access to medications:
►► Avoid lethal medications in bolus form.
►► Remove high-alert medications from care units.
►► Use premixed solutions whenever possible.
►► Label high-alert medications as such.
►► Minimize supplier and product changes.
►► Establish and implement policies and procedures for
►► Use auxiliary labels (such as “for IM
use of off-hours pharmacy.
[intramuscular] only”).
To reduce the likelihood of failures associated with medication delivery:
►► Be sure that equipment defaults to the
►► Recognize that polypharmacy equals higher risk.
least-harmful mode.
►► Use automated pharmacy units as a tool for improving
the process, not an inherent solution.
continued
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Sidebar 6-1.
Risk Points and Risk-Reduction Strategies
for Various Sentinel Events continued
To reduce the likelihood of failures associated with human resources and competence factors:
using electronic order entry.
►► Address education and training issues (orientation,
competence assessment, and training with new medications and devices).
►► Discourage use of acronyms and abbreviations in
general and prohibit the use of specific, high-risk acronyms and abbreviations.
►► Support professional ethics and judgment.
►► Implement systems involving double checks.
►► Control availability of high-risk drugs.
►► Make safe staffing choices.
►► Address environmental issues such as distraction.
►► Avoid reliance on illegible handwriting by providing
►► Standardize medication times.
alternatives such as requiring orders to be printed or
►► Use patients as safety partners.
Wrong-Site Surgery
Risk points
►► Communication before reaching operating suite
►► Multiple surgery sites on patient’s body
►► Communication in operating suite
►► Conflicting chart information
►► Hierarchical issues of communication
►► Confused patient
►► Communication with patient and patient’s family
►► X-ray quality, labeling, and accuracy of interpretation
►► Information availability
Risk-reduction strategies
To reduce the likelihood of failures associated with preoperative procedures:
►► Mark the operative site.
►► Personally review x-rays.
►► Require the surgeon to obtain informed consent.
►► Revise equipment setup procedures.
►► Require preoperative verification by the surgeon, anes-
thesiologist/anesthetist, and patient or family.
To reduce the likelihood of failures associated in an operating suite:
►► Verify patient identity, intended procedure, and opera-
►► Obtain verbal verification with a time-out.
tive site before prep and drape.
►► Confirm the level of spinal surgery with
intraoperative fluoroscopy.
►► Make sure site marking is visible after draping.
Suicide
Risk points
►► Suicide risk assessment
►► Interventions for high-risk patients
►► Communication of risk to direct care staff
►► Psychotropic medications
►► Levels of monitoring required for those at risk
►► Contraband
►► Policies for risk assessment and monitoring outside of
►► Physical environment, including such potential
behavioral health care units (for example, in the emergency department)
hazards as door frames, doorknobs, showerheads, and
bedsheets
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Sidebar 6-1.
Risk Points and Risk-Reduction Strategies
for Various Sentinel Events continued
Risk-reduction strategies
To reduce the likelihood of failures associated in a staffed around-the-clock care setting:
►► Revise assessment and reassessment procedures and
►► Redesign or retrofit security measures.
assure adherence.
►► Educate family and friends on suicide risk factors.
►► Update the staffing model.
►► Consider patients in all areas.
►► Educate staff on suicide risk factors.
►► Ensure that staff members ask about suicidal thoughts
every shift.
►► Update policies on patient observation.
►► Monitor consistency of implementation.
►► Be cautious at times of shift change (admission,
discharge, passes).
►► Revise information transfer procedures.
►► Avoid reliance on pacts.
►► Revisit contraband policies.
►► Be suspicious if symptoms lighten suddenly.
►► Identify and remove nonbreakaway hardware.
►► Involve all staff in solutions.
►► Weight test all breakaway hardware.
Infant Abductions
Risk points
►► Mother and infant identification
►► Entry and exit security
►► Staff identification
►► Mother’s education level or ability to comprehend secu-
rity instructions
►► Visitor identification
►► Policy for issuing alarms when an infant is missing
►► Physical layout of the obstetrics unit
►► Public access to birth information
Risk-reduction strategies
►► Develop and implement a proactive infant abduction
►► Require staff to wear up-to-date, conspicuous, color
prevention plan.
photograph identification badges.
►► Include information on visitor and provider identifica-
►► Discontinue publication of birth notices in local
tion as well as identification of potential abductors or
abduction situations during staff orientation and in-service curriculum programs.
newspapers.
►► Consider options for controlling access to the nursery
or postpartum unit, such as swipe-card locks, keypad
locks, entry point alarms, or video surveillance. (Any
locking systems must comply with fire codes.)
►► Enhance parent education concerning abduction risks
and parent responsibility for reducing risk, and then
assess the parents’ level of understanding.
►► Consider implementing an infant security tag or abduc-
tion alarm system.
►► Attach secure identically numbered bands to the baby
(wrist and ankle bands), mother, and father or significant other immediately after birth.
►► Footprint the baby, take a color photograph of the baby,
and record the baby’s physical examination within two
hours of birth.
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strategy of assessing risk proactively by using failure mode
and effects analysis (FMEA) to identify risk-reduction
opportunities. Also known in the literature as failure mode,
effects, and criticality analysis (FMECA), FMEA offers
a systematic way of examining a design prospectively for
possible ways in which failure can occur. This approach
identifies potential failures in terms of failure modes or
symptoms. Organizations study the effect on the total
system or process for each failure mode, and identify factors
that might cause or enable those failures.
Sidebar 6-2.
The Interrelationship Between
FMEA and RCA
Failure mode and effects analysis (FMEA) and root
cause analysis (RCA) differ in critical ways but also
share similarities.
The fundamental difference is timing: RCA is a retrospective approach, while FMEA is designed to keep
sentinel events from occurring in the first place. RCA
asks “Why?” after an event occurred to identify the root
causes of an event. FMEA asks “What if?” to explore
what could happen if a failure occurred at a particular
step in a process or link.
Actions (planned or already taken) can be reviewed by
organizations for their potential to minimize the probability
of failure or to reduce the effects of failure. FMEA’s goal is
to prevent poor results, which in health care means harm
to patients. Its greatest strength is its capability to focus
users on the process of redesigning processes to prevent the
occurrence of failures.
FMEA and RCA have the following characteristics
in common:
►► Nonstatistical method of analysis
►► Goal of reducing the possibility of future patient harm
►► Involves identifying conditions that lead to harm
Although the technique has been used effectively in the
engineering world since the 1960s, its use in the health care
world began as late as the 1990s. FMEA is now gaining
broader acceptance in health care as a tool for prospective
analysis due to the efforts of The Joint Commission, the
Department of Veterans Affairs National Center for Patient
Safety, and the Institute for Safe Medication Practices,
among others. FMEA is discussed further in Chapter 7.
►► Team activity
In addition, the two methodologies can be—and often
are—interconnected. FMEA can be used during an RCA
to help evaluate various improvement strategies that
resulted from the RCA. FMEA can look at where the
various strategies might fail and identify any new failure
modes that have been introduced as a result of new
design processes. RCA can be used to identify the root
causes of failure modes.
FMEA is described here because root cause analysis teams
may also wish to use FMEA to proactively identify risk-reduction opportunities during their root cause analysis of a
sentinel event or close call or to carry out a proactive risk
assessment on a process that is being redesigned in response
to the findings of a root cause analysis. The interrelationship between FMEA and root cause analysis is further
discussed in Sidebar 6-2, right.
root cause analysis, or the organization might select new
members as required by the recommended improvements.
Improvement actions fall into three basic categories:
1. Actions to prevent errors
2. Actions to shield the patient from the effects of an error
3. Actions to mitigate the effects of an error that reaches
the patient
STEP 13: Formulate Improvement
Actions
“Mistake Proofing”
With the list of root causes in hand, the team is now ready
to start devising potential solutions to systemsrelated problems. Known as corrective actions or improvement actions, these solutions are required to prevent a
problem from occurring or recurring due to the same root
cause(s) or interaction of root causes. The team may include
the same members as during the early stages of the
The ultimate goal of a root cause analysis is the development of actions to reduce the potential for recurrence of
a similar event. The initial focus of improvement actions
should be on eliminating the circumstances that allowed
the outcome. If no action can be applied to eliminate the
cause, the team should seek appropriate measures to reduce
the possibility of recurrence.4
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As discussed in step 12, teams can develop and use a
systematic approach to mistake-proofing processes to avoid
human error in care delivery.
Practice guidelines or parameters and other standardized
patient care procedures are useful reference points for
comparison. Whether developed by professional societies
or in-house practitioners, these procedures represent an
expert consensus about the expected practices for a given
diagnosis or treatment. Assessing variation from such
established procedures can help the team identify how to
improve a process.
A more recent attempt to incorporate mistake proofing in
design is the “smart pump” system for medication infusion.
This system prevents errors by “remembering” the organization’s defined dosing limits and other clinical advisories
entered into the medication library and applying those
“rules” during pump programming. This system helps to
ensure that the right dosage of the medication is infused.
The system also alerts clinicians about potential unsafe drug
therapy before the medication is administered.5
Returning to the sentinel events described in Chapter 3,
consider the following examples of how root cause
analysis teams could approach the identification of
improvement actions.
When formulating corrective action plans, teams should
analyze the strength of their proposed solutions. The US
Department of Veterans Affairs National Center for Patient
Safety has devised a hierarchy of corrective actions that can
be used to gauge the effectiveness of improvement actions
based on how likely they are to reduce vulnerability to an
adverse event (see Table 6-1, page 94).6
In the suicide example, the team has completed a fishbone diagram indicating multiple system problems,
including assessment of suicide risk, environment of care,
and emergency procedures. The team might break into
smaller subgroups. One group (including the psychiatrist,
medical staff leader, and nurse) would address the failed
patient assessment process. They might start by reviewing
the current standard for assessment of suicide risk and how
this standard is communicated in the behavioral health care
unit. Another group (including the administrator and plant
safety representative) might start working on environment
of care issues such as nonbreakaway showerheads. Another
group (including emergency department physicians and the
nursing staff) might work on emergency procedures.
Stronger actions typically involve modifications to the physical environment. For example, after a patient attempted
to commit suicide by hanging from an exposed pipe, the
organization removed the pipe. Weaker actions include
changes in policies, procedures, and training. Although
they are necessary components of an improvement action,
they are considered weaker because they do not change the
underlying conditions that lead to errors. They tend to rely
on human cooperation and vigilance to succeed, and they
often show less immediate results. In a study of root cause
analysis corrective action plans reported by the NCPS,
stronger actions were easier to implement and more effective than weaker actions.7
In the elopement example, the root cause analysis team has
identified multiple system problems, including an unsafe
environment of care; inadequate assessment and reassessment; and inadequate staff orientation, training, and
ongoing competence assessment. One subgroup (including
the safety director, a nurse from the unit, and a social
worker) might address possible actions to improve the
long term care organization’s security and safety measures.
Another small group (including the medical director,
director of nursing, activity staff member, and unit staff
nurse) might address opportunities to improve the process
used to assess and reassess patients at risk for elopement.
Another group (including the medical director, the director
of nursing, and the performance improvement coordinator)
might address strategies to ensure that staff know elopement risk factors and who is at risk for elopement and are
assessed regularly for competence in identifying and caring
for at-risk patients.
Improvement actions should be formulated by thinking in
terms of the everyday work of the organization. Work can
be defined in terms of functions or processes. A function
is a group of processes with a common goal, and a process
is a series of linked, goal-directed activities. Improvement
actions should be directed primarily at processes. As stated
earlier in this book, process improvement holds the greatest
opportunity for significant change, whereas changes related
to an individual’s performance tend to have limited effect.
Competent people often find themselves carrying out
flawed processes.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Table 6-1. Action Hierarchy
Action Category
Stronger Actions
(These tasks require
less reliance on
humans to remember
to perform the task
correctly.)
Intermediate
Actions
Weaker Actions
(These tasks require
more reliance on
humans to remember
to perform the task
correctly.)
DOWNLOAD
Example
Architectural/physical plant changes
Replace revolving doors at the main patient entrance
into the building with powered sliding or swinging
doors to reduce patient falls.
New devices with usability testing
Perform heuristic tests of outpatient blood
glucose meters and test strips and select the most
appropriate for the patient population being served.
Engineering control (forcing function)
Eliminate the use of universal adaptors and
peripheral devices for medical equipment and
use tubing/fittings that can be connected only the
correct way (for example, IV tubing and connectors
that cannot physically be connected to sequential
compression devices or SCDs).
Simplify process
Remove unnecessary steps in a process.
Standardize on equipment or process
Standardize on the make and model of medication
pumps used throughout the institution. Use bar
coding for medication administration.
Tangible involvement by leadership
Participate in unit patient safety evaluations and
interact with staff; support the RCA2 process;
purchase needed equipment; ensure staffing and
workload are balanced.
Redundancy
Use two RNs to independently calculate high-alert
medication dosages.
Increase in staffing/decrease in workload
Make float staff available to assist when workloads
peak during the day.
Software enhancements, modifications
Use computer alerts for drug–drug interactions.
Eliminate/reduce distractions
Provide quiet rooms for programming PCA pumps;
remove distractions for nurses when programming
medication pumps.
Education using simulation-based training, with
periodic refresher sessions and observations
Conduct patient handoffs in a simulation lab/
environment, with after action critiques and
debriefing.
Checklist/cognitive aids
Use pre-induction and pre-incision checklists in
operating rooms. Use a checklist when reprocessing
flexible fiber-optic endoscopes.
Eliminate look- and sound-alikes
Do not store look-alikes next to one another in the
unit medication room.
Standardized communication tools
Use read-back for all critical lab values. Use readback or repeat-back for all verbal medication orders.
Use a standardized patient handoff format.
Enhanced documentation, communication
Highlight medication name and dose on IV bags.
Double checks
One person calculates dosage, another person
reviews their calculation.
Warnings
Add audible alarms or caution labels.
New procedure/memorandum/policy
Remember to check IV sites every 2 hours.
Training
Demonstrate correct usage of hard-to-use medical
equipment.
Source: National Patient Safety Foundation. RCA2: Improving Root Cause Analyses and Actions to Prevent Harm. Boston, MA: National Patient Safety Foundation;
2015. Reproduced with permission.
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In the treatment delay example, the team has identified system problems that led to the missed diagnosis of
metastasized breast cancer. They include communication
problems between caregivers, insufficient staff orientation
and training, and inadequate information management.
Subgroups of the ambulatory health care organization’s
team probe each of these areas for improvement opportunities, looking at such issues as care documentation and the
availability of clinical records, the timeliness and thoroughness of initial and regular reassessments, and shift-to-shift
communication of information related to patient needs.
Wilson and colleagues suggest using the scientific method to
develop a list of potential solutions. They restate the scientific method in terms of steps used in developing solutions8:
1. Become familiar with all the aspects of the problem and
its causes.
2. Derive a number of tentative solutions.
3. Assemble as much detail as is needed to clearly define
what is required to implement these solutions.
4. Evaluate the suggested solutions.
5. Objectively test and revise the solutions.
6. Develop a final list of potential solutions.
In the medication error example, the root cause analysis
team has identified communication of medication orders
and the failure to ensure safe medication storage and access
as two key problems, among others. A subgroup (including
the information technology staff member, pharmacist,
medical director, and home health nurse) might investigate possible strategies to improve the accuracy of orders
communicated to local pharmacies. Another subgroup,
including the nursing supervisor, pharmacy supplier, home
health nurse, and medical director, might investigate strategies to guard against medication theft and ensure proper
implementation of the home health agency’s medication
administration policies and procedures.
These steps may assist the team through the process of both
developing and evaluating improvement actions.
STEP 14: Evaluate Proposed
Improvement Actions
When the list of possible improvement actions is as
complete as possible, the team is ready to evaluate the
alternatives and select those actions to be recommended
to leadership.
To begin the evaluation process, the team should rank the
ideas based on criteria defined by the team. Gathering
appropriate data is critical to this process. A simple 6-point
scale ranging from a low rank of 0 for the worst alternative to a high rank of 5 for the best alternative can be used
at this point. To rank the proposed solutions, Ammerman
suggests using criteria such as compatibility with other
organization commitments and the possible creation of
other adverse effects.9
For each root cause, the team should work interactively
either as a whole or in smaller groups to develop a list of
possible improvement actions. Brainstorming can be used
to generate additional ideas. The emphasis at this point is
on generating as many improvement actions as possible,
not on evaluating the ideas or their feasibility. The number
of suggested improvement actions may vary based on the
nature of the root cause and how it relates to other root
causes. To ensure as thorough a list as possible, the team
may wish to review the analyses of information used to
identify root causes. Remember to encourage any and all
ideas without critiquing them. In the hands of a skilled
facilitator, even the seemingly wildest idea can lead to an
effective improvement action during later stages of analysis. Tools used such as flowcharts or fishbone diagrams can
prompt additional solutions. Ask questions of the group,
such as the following:
• What might fix this problem?
• What other solutions can we generate?
• What other ideas haven’t we thought of?
Initially, to prevent groupthink, it is a good idea to ask each
team member to rank the ideas on his or her own. The
rankings can then be consolidated into a team ranking.
FMEA may be a helpful tool at this point in the process.
FMEA involves evaluating potential problems (or improvement actions) and prioritizing or ranking them on a proactive basis according to criteria defined by a team.
At the very least, every improvement action proposed by
the team should be objective and measurable. If it is
objective, implementation is easier and those affected by
the change are more likely to be receptive. If it is measurable, the team can ensure that improvement actually occurs.
See Checklist 6-2 on page 96 for evaluative criteria for
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improvement actions. Before ranking the actions, ensure
that the team reaches a consensus on which criteria are
most relevant to the organization. Ranking the proposed
ideas according to multiple criteria adds critical dimension
to the evaluation.
Checklist 6-2.
Criteria for Evaluating
Improvement Actions
33 Likelihood of success (preventing recurrence or
occurrence) within the organization's capabilities
33 Compatibility with organization's objectives
33 Risk
33 Reliability
33 Likelihood to engender other adverse effects
33 Receptivity by management/staff/physicians
33 Barriers to implementation
33 Implementation time
33 Long-term (versus short-term) solution
33 Cost
33 Measurability
In evaluating potential improvement actions, the team
should consider the impact of the suggested improvement on organization processes, resources, and schedules.
Sentinel events or close calls frequently shake up the organization’s notions of the resources that should be expended
in particular areas. Organizations contemplating a design
or redesign effort will certainly weigh the availability
of resources against the potential benefits for patients,
customers, and the organization.
Asking some key questions helps the team identify the
potential barriers to implementation of each improvement
action. Relevant questions include the following.
• How will implementation of this action affect other
schedules? How can this be handled?
• What initial and ongoing training will be required?
• How will this impact the schedule, and how will its
impact be handled?
Organization Processes
• How does the proposed action relate to other
projects currently under way in the organization? Are
there redundancies?
• How does the action affect other areas and processes?
• What process-related changes might be required?
• Can affected areas absorb the changes or additional
responsibilities?
Potential Negative Consequences
• Could this action cause problems in other areas or have a
negative impact on other processes?
• Is there a process in place to analyze and take action
if there are unintended, negative consequences from
implementing this action?
• Will the amount of resources required for this action
detract from other quality improvement or patient
safety initiatives?
Resources
• What financial resources will be required to implement
the action? (Include both direct and indirect costs—
that is, costs associated with the necessary changes to
other procedures and processes.) How will these
resources be obtained?
• What other resources (staff, time, management) are
required for successful implementation? How will these
resources be obtained?
• What resources (capital, staff, time, management) are
required for continued effectiveness? How will these
resources be obtained?
• What other activities will have fewer resources as a result
of shifting resource allocation for this change?
With answers to these questions in hand, the team can
better gauge whether the pluses outweigh the minuses.
The team then may wish to revisit the ranking exercises
described previously. Doing so can help clarify which
corrective improvement actions should be selected. To
summarize the potential of each proposed action, the
team can ask, “What will result from implementing this
action?” and “What would result from not implementing
this action?”
Schedule
At this point, the team should be ready to select a finite
number of improvement actions. Each action must do
the following:
• In what time frame can implementation be completed?
• Who will be responsible for making sure it happens?
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• Address a root cause.
• Offer a long-term solution to the problem.
• Have a greater positive than negative impact on other
processes, resources, and schedules.
• Be objective and measurable.
• Have a clearly defined implementation time line.
• Be assignable to staff for implementation.
• Be acceptable to staff most directly affected by
the change.
required to meet these expectations? How and what will the
team measure to determine whether the process is actually
performing at the level expected?
The organization or group needs specific tools to measure
the performance of the newly designed or improved process
to determine whether expectations are met. They can derive
these measures directly, adapt them from other sources,
or create new tools, as appropriate. It is important for the
measures to be as quantitative as possible, meaning that
the measurement can be represented by a scale or range
of values. For example, if the team cites improving staff
competence in calculating medication doses as a corrective
solution, the measure should evaluate competence before
and after each training or educational session. If pretraining
competence tests at 80% to 85% proficiency, posttraining
competence might be set at 90% to 95% proficiency. Or, in
the patient suicide example described back in Sidebar 3-1,
page 48, measures might include the percentage of accurately and appropriately completed suicide risk assessments
as determined through peer review and the percentage of
rooms with breakaway shower fixtures.
The next section describes how the team designs improvements and develops a corrective action plan covering each
of these aspects.
STEP 15: Design Improvements
The product of the root cause analysis is a corrective
action plan that identifies the strategies that the organization intends to implement to reduce the risk of similar
events occurring in the future. The team is now ready to
start drafting such a plan. The plan should address the five
issues of what, how, when, who, and where involved in
implementing and evaluating the effectiveness of proposed
improvement actions.
At times, it may be difficult to establish quantitative
measures—the improvement simply seems to lend itself
more to qualitative measures. Quantification of improvement is critical, however, and even when teams measure
solutions only in terms of risk-reduction potential, it is
important they try to quantify such potential as much as
possible through concrete measures.
Issue One: What
Designing what involves determining the scope of the
actions and specific activities that will be recommended. A
clear definition of the goals is critical. To understand the
potential effects of the improvement activity, the organization must determine which dimension of performance—
safety, effectiveness, patient-centeredness, timeliness,
efficiency, and equity10—will be affected. At times, the team
must consider the relationship between two or more dimensions. Redesign in response to a sentinel event most often
focuses on safety, but it may affect any or all of the other
dimensions. What specific activities will organizations need
to achieve the necessary improvement?
Issue Three: When
Next, the team must define when the organization will
meet its improvement goals. What time frame will the
team establish for implementing the improvement action
and its essential steps? What are the major milestones and
their respective dates? A Gantt chart of one organization’s
improvement plan appears as Figure 6-1, pages 98–99.
Issue Two: How
Issue Four: Who
How does the organization expect, want, and need the
improved process to perform? The team carrying out the
effort should set specific expectations for performance
resulting from the design or improvement. Without these
expectations, the organization cannot determine the degree
of success of the efforts. These expectations can be derived
from staff expertise, consumer expectations, experiences
of other organizations, recognized standards, and other
sources. What sequence of activities and resources will be
Who is closest to this process and therefore should “own”
the improvement activity? Who should be accountable at
various stages? To a great extent, the success of an improvement effort hinges on involving the right people from all
disciplines, services, and offices involved in addressing the
process. The process for taking action consists of several
stages, each of which may have different players.
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Figure 6-1. Improvement Plan and Implementation Status
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Figure 6-1. Improvement Plan and Implementation Status (continued)
This Gantt chart shows a detailed plan created by an organization following a sentinel event involving a mechanical
failure. The chart shows the plan’s steps in implementing strategies, priorities, and expected time frames. The
status of each phase is recorded so that everyone involved has a clear idea of the progress being made.
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Issue Five: Where
The group that creates the process should include the
people responsible for the process, the people who carry
out the process, and the people affected by the process. As
appropriate, the group members could include staff from
different units, branch offices, or teams, services, disciplines,
and job categories. When the group needs a perspective not
offered by its representatives, it should conduct interviews
or surveys outside the group or invite new members into
the group. It is important the group consider customers and
suppliers such as purchasers, payers, physicians, referrals,
accreditors, regulators, and the community as a whole.
Where will the group implement the improvement action?
Will its implementation be organizationwide, in a selected
location, with a selected patient population, or with
selected staff members? Are the location, target population,
and target staff of the improvement action likely to expand
with success? These questions must be resolved before
implementation.
Figure 6-2, below, provides a template for the team to
capture the what, how, when, who, and where involved in
implementing proposed improvement actions.
Leaders and managers must take an active role in overseeing
and setting priorities for design and redesign. Generally,
managers are responsible for processes within their areas.
Upper management or a team of managers should oversee
design or redesign of processes with a wider scope. Leaders
must ensure that the people involved have the necessary
resources and expertise. Furthermore, their authority to
make changes should be commensurate with their responsibility for process improvements. Although regular feedback
and contact with management are important, rigid control
can stifle creativity.
Considering the Impact of Change
When designing improvements, the team should also
consider the impact of change on the organization. No
matter how minor, improvements require change, and it is
normal for individuals and organizations to resist change.
Resistance to change can come from inertia, the challenge
of managing the change process, the challenge of obtaining
necessary knowledge to ensure effective implementation of
the change, and resource limitations.
DOWNLOAD
Figure 6-2. Integrating the Improvement Plan
Planned Improvement: ____________________________________________________________________________
Steps to Be Taken
Date of
Implementation
Areas for
Implementation
Individuals
Responsible
Other
Considerations
Define the time lines and responsibilities associated with each of the project steps using this matrix (customizing
the column headers as needed). Questions to consider include: What are the time lines for each step of the
project and for the project as a whole? What will be the checkpoints, control points, or milestones for project
assessment? Who is responsible for each step or milestone? Who is responsible for corrective course action?
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STEP 16: Ensure Acceptability of the
Change comes in two basic forms: physical and behavioral.
A physical change as a result of a root cause analysis
might be the use of new equipment, such as medication
administration carts. Behavioral change occurs when staff
members abandon established processes and procedures for
corrective ones.
Corrective Action Plan
The team has defined the what, how, when, who, and
where in a corrective action plan. How does the team know
whether it is acceptable to The Joint Commission or Joint
Commission International (JCI) as part of a root cause
analysis in response to a sentinel event?
Understanding the underlying rationale and process
whereby people modify their thinking and practice can help
team leaders gain better insight to their behavior, which in
turn can help leaders identify motivators for personnel to
adopt and maintain desired behaviors. Leaders with this
awareness can also direct project resources to areas where
they will have the greatest impact.
As mentioned in Chapter 1, The Joint Commission or JCI
will consider a corrective action plan acceptable if it does
the following:
• Identifies changes to be implemented to reduce risk or
formulates a rationale for not undertaking such changes
• Where improvement actions are planned, identifies who
is responsible for implementation, when the action will
be implemented (including any pilot testing), and how
the effectiveness of the actions will be evaluated
The stages of change theory posits that when individuals attempt to change a behavior, they progress along a
continuum of five phases: precontemplation, contemplation, preparation, action, and maintenance.11 By gauging
where stakeholders are on the continuum, root cause
analysis teams can identify the motivators that encourage
behavioral change.
The corrective action plan also should include resource
considerations, leadership approval, and buy-in by affected
staff. Teams should consider conducting an FMEA of the
proposed corrective action plan and then proceeding with
some pilot testing.
For example, an organization planning to introduce standardized order sets might learn through surveys, interviews, and in-person discussions that cardiologists have not
thought about standardizing their order sets. Each cardiologist uses his or her own set and is content with it that way.
These physicians do not see a need for change; they are in
the precontemplation stage.
Checklist 6-3, page 102 lists the criteria for an acceptable
corrective action plan.
STEP 17: Implement the
Improvement Plan
When an organization establishes the goals for improvement, it can start planning and carrying out the improvements. The team can implement a pilot test of the
improvement on a small scale, monitor its results, and
refine the improvement actions. The pilot test enables the
team to ensure that the improvement is successful before
committing significant organization resources. Pilot testing
also aids in building support for the improvement plan,
thereby facilitating buy-in by opinion leaders. To pilottest an improvement, the team should follow a systematic
method that includes measuring success, evaluating
improvement efforts, taking additional actions (if necessary), and communicating results.
The transition from precontemplation to contemplation is a
difficult one. People who do not recognize a need to change
are less likely to change behavior than people who are
already considering it. In this situation, the team would
have more success implementing standardized order sets
with a group of physicians who already recognize the
potential benefits.
These physicians would be in the contemplation stage, and
when provided with the necessary information, resources
(for example, template order sets, best practices, the latest
evidence and quality measures), and tools (such as content
and process management systems), they will likely be
willing to adopt the new behavior.
A systematic method for design or improvement of
processes can help organizations pursue identified
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DMAIC
Checklist 6-3.
Criteria for an Acceptable Corrective
Action Plan
Another process improvement model goes by the acronym
DMAIC (pronounced duh-MAY-ick), as shown in Figure
6-3 page 103. The letters stand for Define, Measure, Analyze,
Improve, and Control, the five phases of the process. Used
in root cause analysis, DMAIC acts like a funnel, filtering
through the proximate causes to the most likely root
cause(s), as shown in Figure 6-4, page 104.
33 Identifies changes to reduce risk or provides
rationale for not undertaking changes
33 Identifies who is responsible for implementation
33 Identifies when action(s) will be implemented
33 Identifies how the effectiveness of action(s)
Each phase carries with it a key question that must be
clearly answered before proceeding to the next phase. The
questions and the corresponding actions are the following:
will be evaluated
opportunities. A standard yet flexible process for carrying
out these changes should help leaders and others ensure that
actions address root causes, involve appropriate personnel,
and result in desired and sustained changes. Depending on
an organization’s mission and improvement goals, it may
implement a process improvement using either the scientific method or the Define, Measure, Analyze, Improve,
Control (DMAIC) process.
Define: What is the problem? Form and develop a
project charter.
Measure: What is the extent of the problem? Collect baseline
data and determine key measures.
Analyze: Under what circumstances did the problem occur?
Use statistical analysis tools to analyze the data and the process
to determine the root cause(s).
The Scientific Method
The fundamental components of any improvement process
are the following:
• Planning the change
• Testing the change
• Studying its effects
• Implementing changes determined to be worthwhile
Improve: How can the problem be solved? Develop, evaluate,
refine, and implement solutions to the identified problems.
Control: How can the solution be sustained? Document and
monitor improvements and design controls.
Additional RCA Tools
Many readers will readily associate the activities listed—
plan, test, study, implement—with the scientific method.
Indeed, the scientific method is a fundamental, inclusive
paradigm for change and includes the following six steps:
1. Determine what is known now (about a process,
problem, topic of interest).
2. Decide what needs to be learned, changed, or improved.
3. Develop a hypothesis about the effect of the change.
4. Test the hypothesis.
5. Assess the results of the test. (Compare results of the test
before state versus the changed state.)
6. Implement successful improvements, or rehypothesize
and conduct another experiment.
The following tools are useful for taking action to
improve processes:
• Brainstorming can be used to create ideas for
improvement actions.
• Multivoting can help a team decide between possible
improvement actions.
• Flowcharts can help a team understand the current
process and how the new or redesigned process
should work.
• Fishbone diagrams can indicate which changes might
cause the desired result or goal.
• Pareto charts can help determine which changes are likely
to have the greatest effect in reaching the goal.
• Control charts and scatter diagrams can measure the
effect of a process change or variation in processes
and outcomes.
• Histograms can show how much effect each change
has had.
This orderly, logical, inclusive process for improvement
serves organizations well as they attempt to assess and
improve performance.
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Figure 6-3. DMAIC: Getting Others Involved
Change Management
How Will You Get Others Involved?
Acceptance, Accountability, Buy-In
DEFINE
MEASURE & ANALYZE
IMPROVE
CONTROL
What Needs To Be Improved?
How Do You Know?
How Will You Solve It?
How Will You Make It Last?
Problem Statement
Current State, Root Causes
Targeted Solutions
Sustaining the Gains
Lean Six Sigma
Source: RPI® Yellow Belt Companion Guide. The Joint Commission. 2016
This figure illustrates the problem-solving sequence.
These and the other tools shown in Chapter 7 may be used
individually or in some combination as part of a performance improvement strategy such as Lean Six Sigma.
3. Develop a vision and strategy that is
• Easily pictured
• Attractive
• Feasible and clear
• Flexible
• Communicable
Creating and Managing the Change
Some suggested actions the team might take to help
manage and lead the change or improvement process
follow.12 Based on eight sequential stages in the process of
leading change in organizations,13 the steps in creating and
managing the change process are as follows:
1. Establish a sense of urgency:
• Identify the best anywhere and the gap between one
process and another.
• Identify the consequence of being less than the best.
• Explore sources of complacency.
4. Communicate the changed vision in a way that
• Is simple
• Uses metaphor
• Works in multiple forms
• Involves doing instead of telling
• Explains inconsistencies
• Involves give and take
5. Empower broad-based action:
• Communicate sensible vision to employees.
• Make organization structures compatible with action.
• Provide needed training.
• Align information and human resource systems.
• Confront supervisors who undercut change.
2. Create a guiding coalition:
• Find the right people.
• Create trust.
• Share a common goal.
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6. Generate short-term wins:
• Fix the date of certain change.
• Do the easy stuff first.
• Use measurement to confirm change.
• Eliminate unnecessary dependencies.
• Identify linked subsequent cycles of change.
8. Anchor new approaches in the culture:
• Results
• Conversation
• Turnover
• Succession
7. Consolidate gains and produce more change:
• Identify true interdependencies and smooth
interconnections.
Figure 6-4. DMAIC Model for Root Cause Analysis
Problem Defined
Measure Baseline
Analyze for Root Causes
Why?
Cause
Why?
Cause
Investigation
Cause
Why?
Cause
Why?
Why?
Root
Cause
Improvements and
Countermeasures
Control and
Standardize
The DMAIC model for performance improvement includes five phases—Define, Measure, Analyze, Improve, and Control.
Cause investigation occurs during the analyze phase, as the process filters through the proximate causes to reach the
most likely root cause. Then improvements can be made and sustained.
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STEP 18: Develop Measures of
Data collection efforts should be planned and coordinated
by the team. Use a separate sheet to plan and monitor the
indicators selected to measure each improvement goal.
Effectiveness and Ensure Their Success
When a function or process is under way, the team should
collect data about its performance. As described in Chapter
4, measurement is the process of collecting and aggregating
these data, a process that helps assess the level of performance and determine whether further improvement actions
are necessary.
Who should be responsible for measurement? The team,
empowered to study the process and recommend changes,
is usually responsible for designing and carrying out the
measurement activities necessary to determine how the
process performs. After making changes to improve the
process, the team should continue to apply some or all of
its measures to determine whether the change has had the
desired effect. Organizations may have various experts who
can help design measurement activities, including experts
in information management, quality improvement, risk
management, and the function to be measured. The team
can request such contribution on an ad hoc basis. For
example, if the team is investigating a medication error and
has a large amount of data to codify and process regarding
The first step in measuring the success of improvement
efforts is to develop high-quality measures of effectiveness.
The choice of what to measure is critical. Measurement
must relate to the improvement and validate the accomplishment of the goal (or failure to reach the goal). See
Checklist 6-4 for key questions the team should ask
concerning what to measure. An affirmative answer to the
questions in the checklist gives the team a good indication
that it is on the right track with its efforts to measure the
effectiveness of improvement initiatives.
TIP
Some measures or performance indicators may require
specific targets, which should be set by the team prior to
data collection. For example, in the patient suicide case
described previously in Sidebar 3-1, the team should set
100% as the target for bringing rooms in the behavioral
health care unit into compliance with breakaway shower
fixtures. For the treatment delay example in the same
sidebar, the team should set a score of 95% as the target for
all posttraining test scores.
Make every effort to coordinate any ongoing
measurement with data collection already
taking place as part of the organization’s everyday
activities. For example, if nurses are collecting
blood pressure data as part of their normal
duties, these same data should be used when
assessing the impact of a specific drug on patient
blood pressure.
the administration of a frequently ordered medication, the
team may want to seek the help of information management staff with access to statistical software capable of
analyzing a large volume of data.
Checklist 6-4.
Ensuring the Success of
Measurement
Information management professionals and those responsible for carrying out the process being measured are key
players in data collection and analysis. The people involved
vary widely depending on the specific organization, the
function being measured, and the measurement process.
33 Is there a plan for use of the data?
33 Are the data collected reliable and valid?
33 Has ease of data collection been assured?
33 Have key elements required for improvement
been defined?
33 Has a data rich–information poor syndrome
STEP 19: Evaluate Implementation of
Improvement Efforts
been avoided?
33 Has a key point for information dissemination
After data are collected as part of measurement, they must
be translated into information that the team can use to
been designated?
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make judgments and draw conclusions about the performance of improvement efforts. This assessment forms the
basis for further actions taken with improvement initiatives.
performance against reference databases, professional standards, and trade association guidelines.
The team can use numerous techniques to assess the data
collected. Most types of assessment require comparing data
to a point of reference. These reference points may include
the following:
• Internal comparisons, such as unit-to-unit or
time-to-time
• Aggregate external reference databases
• Desired performance targets, specifications, or thresholds
The team may also establish targets, specifications, or
thresholds for evaluation against which to compare current
performance, such as professional literature or expert opinions within the organization.
Desired Performance Targets
STEP 20: Take Additional Action
The team’s assessment of the data collected indicates
whether or not it has achieved established targets or goals.
If it is achieving the goals, the team’s efforts now should
focus on communicating, standardizing, and introducing
the successful improvement initiatives. The team can do
the following:
• Communicate the results, as described in subsequent
step 21.
• Revise processes and procedures so that the improvement
is realized in everyday work.
• Complete necessary training so that all staff members are
aware of the new process or procedure.
• Establish a plan to monitor the improvement’s
ongoing effectiveness.
• Identify other areas where the improvement could
be implemented.
Internal Comparisons
The team can compare its current performance with its past
performance using statistical quality control tools. Two such
tools are particularly helpful in comparing performance
with historical patterns and assessing variation and stability:
control charts and histograms. These tools respectively show
variation in performance and the stability of performance.
External References
In addition to assessing the organization’s own historical
patterns of performance, the team can compare the organization’s performance with that of other organizations.
Expanding the scope of comparison helps an organization
draw conclusions about its own performance and learn
about various methods to design and carry out processes.
Aggregate external databases come in a variety of forms.
Aggregate, risk-adjusted data about specific indicators
help each organization set priorities for improvement by
showing whether its current performance falls within the
expected range.
Organizations frequently falter when continued measurement indicates they are not sustaining improvement goals.
More often than not, efforts tend to provide short-term
rather than long-term improvement. If the team is not
achieving the improvement goals, then it needs to revisit
the improvement actions by circling back to confirm root
causes, identify a risk-reduction strategy, design an improvement, implement a corrective action plan, and measure the
effectiveness of that plan over time.
One method of comparing performance is benchmarking.
Although a benchmark can be any point of comparison,
most often it is a standard of excellence. Benchmarking is
the process by which one organization studies the exemplary performance of a similar process in another organization and, to the greatest extent possible, adapts that information for its own use. Or the team may wish to simply
compare its results with those of other organizations or with
current research or literature.
There are a number of reasons a team’s improvements may
falter and fail.14 If the team is having trouble effecting
improvement, consider the information shown in Table
6-2, page 107.
STEP 21: Communicate the Results
Throughout the root cause analysis process, the team should
be communicating to the organization’s leadership the team
conclusions and recommendations as outlined by the team
early in the process. Hence, the communication process
Assessment is not confined to information gathered
within a single organization. To better understand its
level of performance, an organization should compare its
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Table 6-2. When Improvements Falter:
Reasons and Remedies
Sidebar 6-3.
Possible Content of Report to Leaders
Human Factors
• Failure to hold the gains because the improvement required
major changes, particularly behavioral changes
• Failure to hold the gains because the improvement created
extra work or hassle
• Failure to hold the gains because new staff or leadership
personnel were not trained in the improved process
• Inability to replicate in other settings
• Not enough public or personal attention to improvement
success
• Inadequate institutional and administrative support
• Hidden barriers to needed changes
• A cookie-cutter approach to replicating improvement
Event Description
This section includes a brief description of the sentinel
event or possible event. It includes what, when, where,
who, and how information as articulated in the problem
definition (see step 2 in Chapter 3, pages 53–57).
The emphasis is on facts related to the event and the
areas involved.
Scope of Analysis
This section describes the team’s membership and
purpose as well as the analytical methods used to
investigate the event or possible event.
Remedies
• Big changes are best arrived at one step at a time.
• Design improvements so that the desired task is the easiest
thing do. Design a robust process that makes it easy to do
things right and difficult to do things incorrectly.
• Ensure continued training of all appropriate staff.
• Build a lasting improvement by recognizing that individuals
adopt innovations after passing through a series of stages,
including knowledge (becoming aware that a new idea
exists), persuasion (forming a favorable attitude toward
the new idea), decision (choosing to adopt the innovation),
implementation (putting the idea into use), and confirmation
(seeking further verification of the innovation, leading to
either continued adoption or discontinuance). Consider
and plan for this process when bringing an improvement to
every setting.
• Leaders must ensure that improvement successes are
recognized and celebrated.
• Leaders must provide time and talent.
• Leaders must empower improvement teams to identify
where changes are needed and help them make the
changes happen.
• Process improvements must be reinvented at each new
site, adapted to meet local circumstances, and fingerprinted
by the local owners of the newly improved process.
Proximate Causes and Immediate Responses
This section describes the circumstances leading to the
event, proximate causes identified by the team, and any
response strategies and corrective actions implemented
by individuals immediately following the event.
Contributing Factors
This section describes the circumstances, actions, or
influences thought to have played a part in the origin,
development, or increased risk of an incident.
Root Causes
This section describes the analyses conducted to determine root causes and lists the root causes identified by
the team.
Improvement Actions and Follow-Up Plan
This section describes the improvement actions
recommended by the team for each root cause. It also
describes the measures and time frame recommended
to evaluate the effectiveness of improvement actions.
Source: Splaine ME, et al, editors: Practice-Based Learning and
Improvement: A Clinical Improvement Action Guide, 3rd ed. Oak Brook, IL:
Joint Commission Resources, 2012.
occurs throughout the team’s effort and is critical to the
success of improvement initiatives.
The team should consider with care how and to whom the
report is to be presented. Participants during a formal oral
presentation should include those whose approval and help
is needed as well as those who could gain from the team’s
recommendations. Consider the following questions in
communicating an improvement initiative:
• How will the team communicate the implementation of
this initiative throughout the organization?
• Who needs to know?
• What communication vehicles will the team use
After determining what happened or could have happened
and identifying root causes of the event or possible event,
the team should provide leadership with the recommendations for improvement actions to prevent a recurrence of
the event. Generally, a short written report provides leaders
with the summary they need. An outline of the contents of
such a report appears as Sidebar 6-3, right.
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DOWNLOAD
Figure 6-5. Communication Plan Template
Project: ____________________________________________________________________________
Audience
Message and Goal
Message and
Goal (for example,
memo,e-mail,
face-to-face,)
Where/How
Who
When
This sample communication template encourages you to identify the audience, message, and media for getting
awareness and buy-in for corrective actions.
for various audiences (individuals both directly and
indirectly affected by the improvement)?
report should include information regarding applicability to
other processes, areas, and locations and the lessons learned.
The team also needs to ensure that communication about
the results will be an ongoing activity that reinforces the
reasons for the improvement initiative. Storytelling is
an effective strategy when reporting the results to a wide
audience at various staff meetings. Storytelling humanizes
the event that caused the root cause analysis, which helps
catch people’s interest and get them emotionally invested in
improvement actions. Storytelling also helps safeguard an
organization against communication leaks. Written reports
have a greater tendency than oral accounts do to leak
outside a facility to media outlets. In some cases this leads
to the media publicly portraying organizations in the worst
possible light by taking incident reports and improvement
plans out of context.
A template for planning the communication strategy for
the roll out across your organization is included as Figure
6-5, above.
References
1. Leape LL. Error in medicine. JAMA. 1994 Dec
21;272(23):1851–1857.
2. Last JM, editor. A Dictionary of Epidemiology, 4th ed. New York:
Oxford University Press, 2001.
3. Nash DB, Goldfarb NI. The Quality Solution: The Stakeholder’s
Guide to Improving Health Care. Sudbury, MA: Jones and
Bartlett, 2006.
4. Hoffman C, et al. Canadian Root Cause Analysis Framework:
A Tool for Identifying and Addressing the Root Causes of Critical
Incidents in Healthcare. Edmonton, AB: Canadian Patient Safety
Institute, 2006.
Following implementation of such actions and measuring
and ensuring their success, the team should report to
leadership on the results of the improvement actions. The
5. Keohane C, et al. Intravenous medication safety and smart
infusion systems: Lessons learned and future opportunities. J
Infus Nurs. 2005 Sep–Oct;28(5):321–328.
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| Designing and Implementing a Corrective Action Plan for Improvement
6. National Patient Safety Foundation. RCA2: Improving Root Cause
Analyses and Actions to Prevent Harm. Boston, MA: National
Patient Safety Foundation; 2015.
11. Schulte SK. Avoiding culture shock: Using behavior change
theory to implement quality improvement programs. J AHIMA.
2007 Apr;78(4):52–56.
7. Hughes D. Root cause analysis: Bridging the gap between ideas
and execution. Topics in Patient Safety. 2006 Nov–Dec;6(5):1, 4.
Accessed July 16, 2017. https://www.patientsafety.va.gov/docs
/TIPS/TIPS_NovDec06.pdf
12. Nelson EC, Batalden PB, Ryer JC, editors. Clinical Improvement
Action Guide. Oakbrook Terrace, IL: Joint Commission on
Accreditation of Healthcare Organizations, 1998, pp. 116–117.
13. Kotter JP. Leading Change. Boston: Harvard Business School
Press, 1996.
8. Wilson PF, Dell LD, Anderson GF. Root Cause Analysis: A Tool for
Total Quality Management. Milwaukee: ASQ Quality Press, 1993.
14. James B, Ryer JC. Holding the gains. In Nelson EC, Batalden
PB, Ryer JC, editors: Clinical Improvement Action Guide.
Oakbrook Terrace, IL: Joint Commission on Accreditation of
Healthcare Organizations, 1998, 121–124.
9. Ammerman M. The Root Cause Analysis Handbook: A Simplified
Approach to Identifying, Correcting, and Reporting Workplace
Errors. New York: Productivity Press, 1998.
10. Institute of Medicine. Crossing the Quality Chasm: A New Health
System for the 21st Century. Washington, DC: National Academy
Press, 2001.
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110
CHAPTER
7
Tools and Techniques
What Is Lean Six Sigma?
Learning Objectives
Lean Six Sigma is a term describing an improvement methodology based on the scientific method, statistical methods,
customer values, and flow and pull principles. In his book
The Machine That Changed the World, James Womack
coined the term Lean to describe the methods of the Toyota
Production System, in which all employees work together
to eliminate waste (of resources and time) and to keep the
process focused on the value of the product to the customer.
The term Six Sigma comes from Motorola’s description of
its methods for improving quality in a systematic way. It
refers to a statistical concept in which a process or output
remains within six standard deviations of the mean value
in a normal distribution. Both Toyota and Motorola have
been widely recognized for high quality. For those who
have worked with both companies and have applied their
methods, Lean Six Sigma is an appropriate label because the
Lean and Six Sigma methods are found in both companies
and are considered inseparable.
• Better understand the improvement methodologies
of Robust Process Improvement® and Lean
Six Sigma
• Become familiar with a variety of analytical tools
and processes, when each is best used, and how
best to apply them
• Implement these tools as part of a comprehensive
systematic analysis
Root cause analysis is a key element in an organization’s
efforts toward performance improvement. Numerous
tools exist within various performance improvement
methodologies, including Robust Process Improvement®
(RPI®) and Lean Six Sigma, to facilitate the process of
root cause analysis and specific issues of patient safety
and quality in health care.
What Is RPI?
DMAIC
The Joint Commission has created its own organizationwide plan of RPI®, a set of strategies, tools, methods, and
training programs for improving business processes. This
blended approach uses Lean, Six Sigma (see next section),
and Change Management methodologies:
• Lean removes waste and increases speed.
• Six Sigma reduces deficits and variation in a process and
improves quality.
• Change Management prepares employees to seek, commit
to, and accept change.
Lean Six Sigma often is applied in a five-step problem-solving approach commonly known by the acronym
DMAIC. It is the core of Six Sigma methodology that
describes its problem-solving sequence:
• D, for Define, is a critical first step to have a clear
understanding of the issue or problem to be solved.
• M stands for Measure, wherein the team assesses the
baseline performance of the process and identifies the
potential contributing factors when the process fails to
meet customer expectations. This step also is essential
because without knowing the current state, one cannot
gauge whether the process improved.
• A is for Analyze, in which the team uses a variety
of analytical and statistical tools to determine the
critical few contributing factors impacting the
examined process.
Key components of RPI include building the expertise of
staff and leadership and embedding tools and methods
into everyday work. The Joint Commission has begun
exporting the RPI methodology by providing training
to external organizations through its Center for
Transforming Healthcare.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Table 7-1. Tool Matrix
Tool Name (Alternate
Name)
Affinity diagram
Identifying Proximate
Causes
Identifying Root Causes
X
X
X
X
Change management
Check sheet
Implementing
and Monitoring
Improvements
X
Brainstorming
Change analysis
Identifying Improvement
Opportunities
X
X
X
Control chart
X
X
Failure mode and
effects analysis
(FMEA)
Fishbone diagram
(Cause-and-effect
diagram)
X
X
Flowchart
X
X
X
X
Gantt chart
X
X
X
X
Histogram
X
X
X
X
Multivoting
X
X
X
Operational definition
X
Pareto chart
Relations diagram
X
Run chart
X
X
X
X
X
X
Scatter diagram
(Scattergram)
X
SIPOC process map
X
Stakeholder analysis
X
Standard work
Value stream mapping
X
X
X
X
X
This matrix lists many of the tools and techniques available during root cause analysis and indicates the stages during which
they may be particularly helpful. Each tool is described in greater detail in this chapter.
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| Tools and Techniques
• I stands for Improve, and the team will statistically
validate that the interventions achieve the results.
• C is for Control to ensure sustained gains.
Stages to Use: Identifying proximate causes, identifying
improvement opportunities
(DMAIC is described in greater detail in Chapter 6, pages
102–104.) Earlier problem-solving methodologies often
have shown limited success in creating interventions that
last. The methodologies forwarded by Toyota and Motorola
thus include key tools to better control the process for longterm success.
1. Choose a team.
2. Define the issue in the broadest and most neutral manner.
3. Brainstorm or brainwrite (for example, for contributing
factors or for suggested improvements) and record the ideas.
4. Randomly display sticky notes with the ideas so that
everyone can see them.
5. Sort the ideas into groups of related topics.
6. Create header or title cards for each grouping.
7. Draw the diagram, connecting all header cards with
their groupings.
Simple Steps to Success:
Any employee can learn Lean Six Sigma. One’s level of
expertise is often signified by a “belt” designation: Yellow
Belt, Green Belt, Black Belt, Master Black Belt, or Sensei,
awarded following training at that level.
Effective Use Tips
Green Belts may be taught basic statistical tools as well as
the flow and pull concepts from the Toyota Production
System. Flow (continuous forward movement) in a process
is desired as a sign that the process quality and productivity
are higher than a process that repeatedly stops and starts.
Pull refers to how the inputs of the process are replenished
based on the customer’s demand rather than the organization’s timetable.
Encourage team participation by doing
the following:
►► Keep the team small (four to six people) and
ensure varied perspectives.
►► Generate as many ideas as possible using
brainstorming guidelines.
►► Record ideas from brainstorming on sticky
notes to ensure that all participants have the
opportunity to share their ideas.
This chapter provides information on tools and techniques
that can be used during root cause analysis. The tools and
techniques appear in a uniform format, a tool profile, to
assist readers with their selection and use. Each tool profile
identifies the purpose of the tool or technique, the stage of
root cause analysis during which the tool or technique may
be used, basic usage steps, and tips for effective use. An
example of the tool or technique follows each profile.
►► Consider brainwriting, a strategy in which
participants write their ideas, rather than
delivering them orally, as a strategy to increase
participation and decrease extraneous
conversation.
►► Sort the ideas in silence, being guided in sorting
only by gut instinct.
►► If an idea keeps getting moved back and forth
from one group to another, agree to create a
duplicate note.
When embarking on a root cause analysis, team members
may wish to start by consulting the tool matrix shown
in Table 7-1 on page 112. This matrix lists many of the
tools and techniques available during root cause analysis
and indicates the stages during which they may be
particularly helpful.
►► Reach a consensus on how notes are sorted.
►► Allow some ideas to stand alone.
►► Make sure that each idea has at least a noun
and a verb when appropriate; avoid using
single words.
Affinity Diagram
►► Break large groupings into subgroups with
subtitles, but be careful not to slow progress with
too much definition.
(See Figure 7-1)
Purpose: To creatively generate a large volume of ideas or
issues and then organize them into meaningful groups
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 7-1. Example: Affinity Diagram
Laboratory reports not
on chart at 8 A.M.
Lab routine
Lab results
Lab ordering
Labs designated as daily not drawn
until 10 AM
Lab reports not printed until 10:30 AM
Intensive care unit and stat orders
take precedence
Intensive care unit and telemetry
drawn first
Results available in lab system
before until system
Too many stat orders when
physicans discover no labs
Time to draw certain labs
Lab results not printed by secretary
Increased cost of stat labs
No way to tell if patient is
preoperative
Labs not placed on front of chart
Labs ordered incorrectly
Main secretary ill
Too many types or times to
choose from
This affinity diagram shows how a wide range of ideas—such as those generated from a brainstorming
or brainwriting session—can be arranged in manageable order. This example presents ideas on why
laboratory results are not available as needed in three categories: routine, results, and ordering.
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| Tools and Techniques
3. Set a time limit. Allow enough time for every member
to make a contribution, but keep it short to prevent
premature analysis of ideas.
4. Generate ideas. Use a structured format in which the
group members express ideas by taking turns in a
predetermined order, one idea per turn. The process
continues in rotation until either time runs out or ideas
are exhausted.
5. Clarify ideas. The goal is to make sure that all ideas are
recorded accurately and are understood by the group.
Brainstorming
(See Figure 7-2)
Purpose: To generate multiple ideas in a minimum amount
of time through a creative group process
Stages to Use: Identifying improvement opportunities
Simple Steps to Success:
1. Define the subject. Doing so ensures that the session has
direction.
2. Think briefly about the issue. Allow enough time for team
members to gather their thoughts, but not enough time
for detailed analysis.
Figure 7-2. Example: Brainstorming List
Possible factors contributing to a surgical error may
include the following:
►► No timely case review
►► No mechanism to ensure patient identity
Effective Use Tips
►► Informal case referral process
►► Create a nonthreatening, safe environment for
►► Untimely operative dictation
expressing ideas.
►► Inadequate presurgical evaluation
►► Tell the group up front that any idea is welcome,
no matter how narrow or broad in scope or how
serious or light in nature. All ideas are valuable,
as long as they address the subject at hand.
►► No review of patient care information prior
to surgery
►► Inadequate informed consent
►► Remember that the best ideas are sometimes the
►► Patient care information unavailable for
most unusual.
preoperative review
►► Allow group members to occasionally say “pass”
if they can’t think of an idea when it’s their turn
to speak.
►► Failure to perform surgery in a safe manner
►► Laterality not clearly identified
►► Never criticize ideas. It is crucial that neither the
►► Delay in reporting of incident
leader nor the other group members comment
on any given idea.
►► No multidisciplinary review
►► In thinking briefly about the issue (step 2), do
►► Ignored pathology reports
not give group members time to second-guess
their ideas. Be aware that self-censorship stifles
creative thought.
►► History of inadequate documentation in
medical record
►► Write down all ideas on a chalkboard or easel so
►► Procedures performed without adequate expertise
that the group can view them.
►► Failure to take responsibility for actions
►► Keep it short; enforce a time limit of 10 to
20 minutes.
►► No surgical plan/preoperative findings
►► In organizations where staff may not regularly
This figure shows an excerpt from a list one organization
created using brainstorming to identify possible
contributing factors in a surgical error that occurred. This
list was used to create the fishbone diagram that appears
as Figure 7-8, page 124. As the example shows, the
ideas are widely varied, and some seem more viable than
others. Remember that brainstorming is for generating
ideas, not sorting or judging them.
be in a centralized location, brainstorming can be
done by asking staff to submit as many ideas as
possible about the topic in writing, by voice mail,
or by e-mail.
►► Make a note of deeper root causes that emerge
during brainstorming and place them in a “parking
lot” list for consideration later.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Effective Use Tips
Change Analysis
►► Describe the problem as accurately and in as
(See Figure 7-3; or, a blank template is available in
the e-book DOWNLOAD or on the flash drive.)
much detail as possible. Include in the description
who was involved, what might have been a factor
in causing the event, where the event took place,
and when it took place.
Purpose: To determine the proximate and root cause(s) of
an event by examining the effects of change. This involves
identifying all changes, either perceived or observed, and all
possible factors related to the changes.
►► After a change analysis is performed, additional
questions must be asked to determine how the
changes were allowed to happen.
►► Continue the questioning process into the
Stages to Use: Identifying proximate causes; identifying
root causes
organization’s systems.
►► Remember that not all changes create problems;
rather, change can be viewed as a force that can
either positively or negatively affect the way a
system, process, or individual functions.
Simple Steps to Success:
1. Identify the problem, situation, or sentinel event.
2. Describe an event-free or no-problem situation. Try to
describe the situation without problems in as much
detail as possible. Include the who, what, where, when,
and how information listed in step 1.
3. Compare the two. Take a close look at the event and
nonevent descriptions, and try to detect how these
situations differ.
4. List all the differences.
5. Analyze the differences. Carefully assess the differences
and identify possible underlying causes. Describe how
these affected the event. Did each difference or change
explain the result?
6. Integrate information and specify root cause(s). Identify
the cause that, if eliminated, would have led to a
nonevent situation.
Figure 7-3. Change Analysis Worksheet
Event
Who was involved?
What conditions may have
contributed?
When and where did the
event take place?
Nonevent
Differences
What was the expected or
desired series of events and/
or outcome?
What differences are
apparent?
Analysis
What is the underlying cause
of the variation?
This worksheet shows a simple way of listing and comparing information for change analysis. The worksheet is
arranged in columns to show logically what happened, what did not happen, the difference between them, and
an analysis. The questions included in each column provide starting points for discussion.
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| Tools and Techniques
Effective Use Tips
Change Management
►► Engage the right people early in your initiative
(See Figure 7-4)
to help you build a base of support and identify
points where there may be resistance to change.
Purpose: To encourage organizational acceptance of a
change in process within a system
►► Understand that resistance to change is a natural
human reaction, and assure key stakeholders in
the process that their voices will be heard.
Stages to Use: Identifying improvements; implementing
and monitoring improvements
►► Consider the change’s effect on overall
organizational culture, not just one process.
Simple Steps to Success:
1. Determine the need for the change.
2. Secure leadership buy-in.
3. Anticipate resistance to change from staff who will be
affected by the change.
4. Communicate a vision of the improvement that will result
from the change.
5.
6.
7.
8.
Seek input from staff members in designing the change.
Implement the change.
Gauge the effectiveness of the change.
Modify the change, if necessary, to reach the
desired result.
9. Maintain support for the change.
Figure Change
7-4. ChangeModel
Management
Facilitating
Plan Your
Project
Launch
the
Initiative
Inspire
People
Support
the
Change
Facilitating Change
1
►► Assess the culture.
Plan Your Project
Inspire People
►► Make it personal.
►► Define the change.
►► Solicit support and
►► Assemble a strategy.
►► Engage the right people.
►► Brainstorm barriers to
involvement.
Launch the Initiative
►► Align operations and
infrastructure.
►► Get the word out.
Support the Change
►► Permeate the culture.
►► Monitor progress.
►► Sustain the gains.
►► Look for resistance.
►► Lead change.
success.
►► Build the need for change.
►► Paint a picture of the
future state.
The figure above provides the Facilitating Change Model, which is used to identify, implement, and monitor
improvements and to gain organizational support for process changes in a system.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Effective Use Tips
Check Sheet
►► Determine which data matter for your purpose
(See Figure 7-5; or, a blank check sheet is
­available in the e-book DOWNLOAD or on the
flash drive.)
and include that on the check sheet.
►► Use the data recorded on the check sheet to
create a control chart, histogram, or bar chart for
further analysis.
Purpose: To sort and group data, using hatch marks
or similar symbols, onto a form that can be used with
other tools
►► Investigate findings of process variations, and
identify opportunities for improvement.
Stages to Use: Identifying proximate causes
row could be labeled with an observation or defect while
the columns represent distinct time periods.
3. Train data collectors in the data definitions and use of
the form.
4. Have team members record the data by placing a check
mark, hatch mark, X, or other symbol next to the
appropriate value each time the targeted event or
problem occurs.
Simple Steps to Success:
1. Determine what data are to be collected and develop
operational definitions. Decide when data collection will
start and end.
2. Design a simple form labeling rows and columns
representing the appropriate values. For example, each
Figure 7-5. Example: Check Sheet
Interruptions to Medication Administration Preparation
Reason
Day
Mon
Tue
Wed
Thu
Fri
Total
Info request
||||
||
|
||||
|||| ||
20
Patient call
light
||
||
||
||
||
10
MD
||||
||
|||| ||
|
||||
19
Total
12
6
10
8
13
49
The data in the check sheet can be used to identify process variations and identify
ways to improve those processes.
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| Tools and Techniques
Effective Use Tips
Control Chart
►► Obtain data before making any adjustments to
(See Figure 7-6)
the process.
►► In plotting data points, keep the data in a logical
Purpose: To identify the type of variation in a process and
whether the process is statistically in control
time-ordered sequence.
►► Be aware that special causes of variation,
or causes not inherently present in systems,
must be eliminated before the process can be
fundamentally improved and before the control
chart can be used as a monitoring tool.
Stages to Use: Implementing and monitoring
improvements
Simple Steps to Success:
►► The terms in control and out of control do not
1. Choose a process to evaluate, and obtain a data set.
2. Calculate the average.
3. Calculate the standard deviation. The standard deviation
is a measure of the data set’s variability.
4. Set upper and lower control limits. Typically these are set
by multiplying the standard deviation by 3 and then
adding/subtracting that from the mean.
5. Create the control chart. In creating the control chart,
plot the mean (that is, center line) and the upper and
lower control limits.
signify whether a process meets the desired level
of performance. A process may be in control
but consistently poor in terms of quality, and the
reverse may be true.
►► Charting something accomplishes nothing; it
must be followed by investigation and
appropriate action.
►► Processes as a rule are not static. Any change
can alter the process distribution and should
trigger recalculation of control limits when the
process change is permanently maintained and
sustained (that is, greater than 8 to 12 points on
one side of the process mean, or center line).
TIP
►► Some special causes of variation are planned
Calculating Standard Deviation
Standard deviation is a measure of the variability
of a set of numbers, or data set. Some spreadsheet
software will calculate the standard deviation for
you, but if you need to calculate the standard
deviation for your data set on your own, follow
these steps:
1. Calculate the mean by adding all the members
in your data set together and dividing the sum
by the number of members in your data set.
changes to improve the process. If the special
cause is moving in the right direction toward
improvement, retain the plan. It is working.
►► Use the following four rules to identify out-of-
control processes:
1. One point on the chart is beyond three standard deviations of the mean.
2. Two of three consecutive data points are on
the same side of the mean and are beyond
two standard deviations of the mean.
2. Next, calculate the difference between each of
your data points and the mean by subtracting
the mean from each number in your data set.
3. Four of five consecutive data points are on the
same side of the mean and are beyond one
standard deviation of the mean.
3. Then square each of the results to make them
all positive numbers.
4. Eight data points are on one side of the mean.
4. Calculate the mean of these squared numbers
by adding them together and dividing by the
number of numbers. The resulting number is
called the variance.
6. Plot the data points for each point in time, and connect
them with a line.
7. Analyze the chart and investigate findings including paying
particular attention to any points that lie outside of the
control limits.
5. Finally, take the square root of the variance in
order to cancel out the squaring in step 3. This is
the standard deviation of your data set.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 7-6. Example: Patterns in Control Charts
These two control charts illustrate different patterns of performance an organization is likely to
encounter. When performance is said to be in control (top chart), it does not mean desirable;
rather, it means a process is stable, not affected by special causes of variation (such as
equipment failure). A process should be in control before it can be systematically improved.
When one point jumps outside a control limit, it is said to be an outlier (bottom chart). Staff
should determine whether this single occurrence is likely to recur.
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| Tools and Techniques
Effective Use Tips
Failure Mode and Effects
Analysis (FMEA)
►► Calculate risk and assign priority numbers
(See Figure 7-7 for an FMEA rating scale; or,
an FMEA template is available in the e-book
DOWNLOAD or on the flash drive.)
►► Risk priority numbers (RPNs) may be calculated
relative to frequency of occurrence, severity, and
likelihood of detection.
as a simple product: multiply the ratings for
severity of effect by likelihood of occurrence by
ability to detect.
Purpose: To examine a prospective design for possible ways
in which failure can occur so that actions can be taken to
eliminate the possibility of failure, stop a failure before it
reaches people, or minimize the consequences of a failure
►► Remember that this type of analysis is generally
proactive (used before an adverse event occurs),
although use during root cause analyses to
formulate and evaluate improvement actions is
also recommended and described in this book in
Chapter 6 on pages 86–92.
Stage to Use: Identifying opportunities for improvement
Simple Steps to Success:
►► Ideally, assign an FMEA facilitator with FMEA
1. Select a high-risk process and assemble a team. Pick a
process that is narrow in scope and supported by data or
staff feedback that suggest a high potential failure rate.
2. Diagram the process. Develop either a flowchart or
detailed process flow (outline format) of the process
under analysis.
3. Brainstorm potential failure modes. For each step in
the process, brainstorm or brainwrite a list of things
that could possibly go wrong. These are your potential
“failure modes.”
4. Prioritize failure modes (often accomplished through
calculating a risk priority number or RPN, see Figure
7-7). Determine the effects of the failure modes and
determine the most frequent and potentially most severe.
5. Find root causes of failure modes. Investigate each mode
and attempt to determine its root cause and identify
contributing factors (that is, those factors that allowed a
problem to occur).
6. Redesign the process. Develop a plan addressing how the
root causes and contributing factors of selected failure
modes will be addressed, by whom, when, how the
improvement will be assessed, and so forth.
7. Analyze and test the new process.
experience who is not a direct supervisor, as
the presence of a supervisor may inhibit a frank
discussion of process failures. Team members
should be drawn from all departments that
the process involves and include those who
participate directly in the process and have
first-hand knowledge of how it actually operates
during daily work.
►► Explain the FMEA methodology to the team
and emphasize that it is intended as a proactive
measure to identify and correct or mitigate
potential failures, not to expose wrongdoing or
incompetence by staff. A thorough explanation
of the process will help build trust and a sense
that the organization will follow through with
improvement projects.
8. Implement and monitor the redesigned process. If
performance data must be collected that is not already
being collected by the organization, designate what
data will be collected, how, and by whom. Monitor
performance in the selected process to determine if the
changes are having the desired effect.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 7-7. FMEA Rating Scale
Rating
Severity of Effect
Rating
10
Hazardous without warning
10
9
Hazardous with warning
9
8
Loss of primary function
8
7
Reduced primary function
performance
7
6
Loss of secondary function
6
5
Reduced secondary function
performance
5
4
Minor defect noticed by most
customers
3
Likelihood of Occurrence
Rating
Ability to Detect
10
Cannot detect
9
Very remote chance of
detection
8
Remote chance of detection
7
Very low chance of detection
6
Lower chance of detection
5
Moderate chance of
detection
4
4
Moderately high chance of
detection
Minor defect noticed by
some customers
3
3
High chance of detection
2
Minor defect noticed by
discerning customers
2
2
Very high chance of
detection
1
No effect
1
1
Almost certain detection
Very High: Failure Almost
Inevitable
High: Repeated Failures
Moderate: Occasional Failures
Low: Relatively Few Failures
Remote: Failure is Unlikely
A team conducting an FMEA can be trained to use this rating scale to prioritize how to address failure modes. A simple
calculation for assigning a risk priority number (RPN) is to multiply the ratings for severity of effect by likelihood of
occurrence by ability to detect.
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| Tools and Techniques
Effective Use Tips
Fishbone Diagram
►► Make sure everyone agrees on the problem
(Synonym: cause-and-effect diagram)
(See Figure 7-8)
statement or outcome.
►► Be succinct and stay within the team’s realm
of control.
Purpose: To present a clear picture of the many causal relationships between outcomes and the contributing factors in
those outcomes
►► Gather data to determine the relative frequencies
of the causes.
►► Look for causes that appear continually in the
evaluation process.
Stages to Use: Identifying proximate causes; identifying
root causes
►► Keep asking “Why?” to reach the root cause.
►► Focus on system causes, not on causes
Simple Steps to Success:
associated with individual performance.
1. Identify the outcome or problem statement (that is, the
effect) and write it in a box on the right side of the page,
halfway down, with a horizontal line extending from it
across the page.
2. Determine general or common categories of the problem
(which could be as generic as methods, staffing, training,
environment, and so forth). Draw “ribs” extending
vertically from the horizontal line, or “spine” and label
each rib with a general category.
3. Brainstorm all the possible proximate and underlying causes
under each general category.
4. List proximate (or apparent) causes under each general
category, each with its own subsequent rib.
5. List underlying (or latent) causes related under each
proximate cause.
6. Evaluate the diagram.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 7-8. Example: Fishbone Diagram
PATIENT
PERSONNEL
Medical condition
Denial of suicide ideation
Lack of Education
• Depression assessment education
inadequate
• History alcohol abuse
• No history of prior
psychiatric hospitalization
• DTs (delirum tremens)
• “No Suicide” contract
signed
Inadequate Staff
• Recent alcohol
consumption (24 hr)
• Cost
• Availability
• Psychosis trigger
Admit Status
• Orientation procedures (content,
timeliness)
• Attrition
• EDO (emergency detention
order)
• 15-minute checks
• Unassertive supervision
• Unavailability of staff
• Danger to self and others
• No routine medications
given by law and state statute
Suicide Death
in Mental
Health Unit
Safety Features
Initial Intervention
• Hazard present
• Grab bar 33” from floor not
previously determined to
be hazard
• Direct observation of patient
• No visualization of
bed areas
• Physical layout
• Not an open dorm
• Access not
restricted
ENVIRONMENT
Hazard Rounds
• “No Suicide” contract
• Psychiatric evaluation
not performed
• By persons unfamiliar with
psychiatric needs
Admission Procedure
• Communication with case manager
not thorough
• Written/verbal report incomplete
• Inadequate orientation with community
mental health state
• Assignment of personnel
• Lack of education
• Lack of criteria
Observation Status Inadequate
• Patient denied
• Patient not seen by psychiatrist upon admit
Multiple Admissions
• Personnel not following procedure
• Time of day
• Only provider
• Inadequate assessment by staff
WORK METHODS
This figure illustrates how a generic fishbone diagram can be adapted to specific needs. This detailed diagram breaks
down the contributing factors that led to a sentinel event—the suicide of a patient in a mental health unit. By analyzing
the proximate and underlying causes listed, staff members can identify and prioritize areas for improvement.
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| Tools and Techniques
Effective Use Tips
Flowchart
►► Ensure that the flowchart is constructed by
(See Figure 7-9)
the individuals actually performing the work
being charted.
Purpose: To help teams understand all steps in a process
through the use of common, easily recognizable symbols,
illustrating the actual path a process takes or the ideal path
it should follow
►► Be sure to examine a process within a system,
rather than the system itself.
►► If the process seems daunting and confusing,
create a simple high-level flowchart containing
only the most basic components. Do not include
too much detail; be wary of obscuring the basic
process with too many minor components.
Stages to Use: Identifying proximate causes; identifying
root causes; identifying opportunities for improvement;
implementing and monitoring improvements
►► Use adhesive notes placed on a wall to
experiment with sequence until the appropriate
one is determined.
Simple Steps to Success:
1. Define the process to be charted, and establish starting and
ending points of the process.
2. Brainstorm activities and decision points in the process.
Look for specific activities and decisions necessary to
keep the process moving to its conclusion.
3. Determine the sequence of activities and decision points.
4. Use the information to create the flowchart. Place each
activity in a box, and place each decision point in
a diamond. Connect these with lines and arrows to
indicate the flow of the process.
5. Analyze the flowchart. Look for unnecessary steps and
redundancies, and any other difficulties.
►► Make the chart the basis for designing an
improved process, using spots where the process
works well as models for improvement.
►► Create a separate flowchart that represents the
ideal path of the process, and then compare the
two charts for discrepancies.
►► Keep in mind that difficulties probably reflect
confusion in the process being charted, and work
through them.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 7-9. Example: Medication Administration Flowchart
Prescriber
writes order
Order is entered
into computer
system
Is order
understandable
and compatible
with patient’s
record?
Pharmacy receives
computerized
order
No
Call perscriber to
verify order
Prescriber clarifies
or changes order
Yes
Pharmacy fills
order
Order arrives on
unit
Call physician to
verify correctness
of order
Call pharmacist to
verify correctness
of medication
No
Is the
medication
correct?
Does it match
the patient
chart?
Yes
Nurse administers
medication
This flowchart shows the basic steps in a traditional medication-use system. The process components are arranged
sequentially, and each stage can be expanded as necessary to show all possible steps.
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| Tools and Techniques
Effective Use Tips
Gantt Chart
►► Leave enough space in the time line to write
(See Figure 7-10)
beneath each time period.
Purpose: To graphically depict the time line for long-term
and complex projects, enabling a team to gauge its progress
and track its schedule
►► Write entries in a stair-step fashion, each step
Stages to Use: Identifying proximate causes; identifying
root causes; identifying opportunities for improvement;
implementing and monitoring improvements
►► If the project is very complex and lengthy,
below the one before it, so that overlapping steps
are clearly indicated.
►► Color in the rectangles as each step is completed.
consider creating a Gantt chart for each phase or
each quarter of the year.
Simple Steps to Success:
4. Indicate on the vertical axis where the steps fall. Each step
should be plotted in relation to the projected time line
that appears above, in a bar that spans the appropriate
length of time needed to complete the step beginning
and ending at the time frames identified in step 2.
5. Chart the progress of each process step.
6. Observe the progress and determine if changes should be
made to either the process or the timeline to successfully meet
project requirements.
1. Identify the major steps or processes involved in the project
using a flowchart or other tool. Also identify the sequence
of events and any interdependencies or milestones.
2. Agree on start and stop dates for the project and its
major steps.
3. Draw a time line on a horizontal axis using days or weeks,
depending on the scale most appropriate for your plan.
Figure 7-10. Example: Gantt Chart
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Assess needs
Assess current capabilities
Compile request for proposal
Assess vendor products
Select product
This simple Gantt chart shows a time line for the basic steps an organization might take in the first
phase of selecting a new information system. The chart illustrates the targeted start and end date
for each step in the process.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Histogram
Effective Use Tips
(See Figure 7-11)
►► Data should be variable (that is, measured on
a continuous scale such as temperature, time,
weight, speed, and so forth).
Purpose: To provide a snapshot of the way data are
distributed within a range of values and the amount of
variation within a given process, suggesting where to focus
improvement efforts
►► Make sure data are representative of typical and
current conditions.
►► Use more than 50 data points to ensure the
emergence of meaningful patterns.
Stages to Use: Identifying proximate causes; identifying
root causes; identifying opportunities for improvement;
implementing and monitoring improvements
►► Be sure that the classes are mutually exclusive
so that each data point fits into only one class.
►► Using class intervals of 10 units makes for easier
mental calculations.
Simple Steps to Success:
►► Be aware that the number of intervals can
Number of Occurrences in Third Quarter
1. Obtain the data sets, and count the number of data points.
(You need at least 50 consecutive data points.)
2. Determine the range for the entire data set by subtracting
the smallest value from the largest value.
3. Set the number of classes (or bars) into which the data will
be divided.
4. Determine the class width by dividing the total range of
the data by the number of classes. Use your judgment to
adjust the width to a convenient number, but it must
not have more decimal places than the numbers you are
graphing.
5. Establish class boundaries (or edges). Choose a convenient
number to be the lower edge of the first bar, lower than
any of the data values.
6. Construct the histogram. Place the values for the classes on
the horizontal axis and the frequency on the vertical axis.
7. Count the data points in each class, and create the bars.
Keep adding the class width to find the lower edge of
each successive bar.
8. Analyze the findings.
influence the pattern of the sample.
►► Be suspicious of the accuracy of the data if the
histogram suddenly stops at one point without
some previous decline in the data.
►► The shape of a histogram reflects the statistical
mean and median. If the histogram is skewed
right, the mean is greater than the median. If the
histogram is close to symmetric (that is, the data
are roughly the same in height and location on
either side), then the mean and median are close
to each other. If the histogram is skewed left, the
mean is less than the median.
►► Remember that some processes are naturally
skewed; do not expect a normal pattern
every time.
►► Large variability or skewed distribution may signal
that the process requires further attention.
►► Take time to think of alternative explanations for
the patterns seen in the histogram.
Figure 7-11. Example: Histogram
50
40
30
20
10
0
1–5
6–10
11–15
16–20
21–25
Days
This sample histogram was developed by an infusion therapy service to analyze turnaround time for authenticating
verbal orders from physicians. The irregular distribution suggests that the process is not producing a predictable
result and that improvements to the process may improve predictability and performance.
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Effective Use Tips
Multivoting
►► Ensure that when combining ideas on the lists,
(See Figure 7-12)
the team members who suggested the ideas
agree with the new wording.
Purpose: To narrow down a broad list of ideas (that is,
more than 10) to those that are most important and worthy
of immediate attention
►► Clearly define each idea so that it is easily
understood by everyone voting.
►► Dot voting, a variation of multivoting, involves
writing the choices on sticky notes or paper
stuck to a wall and giving each team member a
number of colored stickers to distribute among
the listed options.
Stages to Use: Identifying proximate causes; identifying
root causes; identifying opportunities for improvement
Simple Steps to Success:
1. Using a brainstorming list or other list, combine any
items on the list that are the same or similar.
2. Determine the number of points each group member can
assign to the list and whether you will use a “passion
vote,” that is, allowing each member to have one vote
that is weighted more heavily (typically 3 to 5 points).
Each member uses a predetermined number of points
(typically between 5 and 10) to vote on the items on
the list.
3. Allow time for group members to assign their
individual points.
4. Tally the votes.
5. Note items with the greatest number of points.
6. Choose the final group, or multivote again.
Figure 7-12. Example: Multivoting
Improvement Opportunities
Number of Votes
A. Facility safety management
3
B. Patient education
7
C. Staff orientation
5
D. Referral (authorization)
3
E. Care coordination and communication
1
F. Laundry
7
G. Medication profile
5
This figure shows the results of multivoting on priorities for improvement at an Indian health center. The team
was able to reach consensus on the need for prioritizing the laundering and patient education processes.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Effective Use Tips
Operational Definition
►► Be as concise as possible.
(See Figure 7-13)
►► If the definition has no numbers in it, it may
not be specific enough and could possibly be
further revised.
Purpose: To remove ambiguity so that everyone has the
same understanding of the issue being defined
Stages to Use: Identifying improvement opportunities
2. Determine the particular means of measurement that
would be appropriate in supporting the definition.
3. Write the definition, including the specific, concrete
measurement criteria to be used in determining whether
the terms of the definition have been met.
Simple Steps to Success:
1. Consider what is to be defined. It may be a project charter,
a customer requirement, or an aspect of data collection.
Figure 7-13. Example: Operational Definition
Medication errors: Number of patient deaths, paralysis,
coma, or other major permanent loss of function
associated with a medical error
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| Tools and Techniques
Effective Use Tips
Pareto Chart
►► If the team is working from a fishbone diagram,
(See Figure 7-14)
the topic is the effect that has been targeted for
improvement. (See the Fishbone Diagram tool
profile, pages 123–124.)
Purpose: To show which events or causes are most frequent
and therefore have the greatest effect. Doing so enables a
team to determine what problems to solve and in what order.
►► When selecting factors for comparison, beware of
grouping several distinct problems together, which
can skew the rank order. Refer to the fishbone
diagram, and use the most specific causes and
factors possible.
Stages to Use: Identifying root causes; identifying oppor­
tunities for improvement
►► Be sure to mark the chart clearly to show the
Simple Steps to Success:
standard of measurement.
1. Decide on a topic of study. The topic can be any
outcome for which several potential causes have
been identified.
2. Select causes or conditions to be compared. Identify the
factors that contribute to the outcome—the more
specific, the better.
3. Set the standard for comparison. In many cases, the
standard is frequency, although factors may be
compared based on their cost or quantity.
4. Collect data. Determine how often each factor occurs
(or the cost or quantity of each, as appropriate). Use a
checklist to help with this task.
5. Make the comparison. Based on the data collected in the
previous step, compare the factors and rank them from
most to least.
6. Draw the chart’s vertical axis. On the left side of the
chart, draw a vertical line and mark the standard of
measurement in increments.
►► When analyzing the chart, keep in mind that
numbers do not always tell the whole story.
Sometimes two severe complaints deserve more
attention than 100 minor complaints.
7. List factors along the horizontal axis. Factors should be
arranged in descending order, with the highest-ranking
factor at the far left.
8. Draw a bar for each factor. The bars represent how
often each factor occurs, the cost of each factor, or its
quantity, as applicable.
9. Include additional features, if desired. By making a
few simple additions to the chart, a team can show
the cumulative frequency, cost, or quantity of the
categories in percentages.
10. Add up the percentages. All the percentages for the
causes need to add up to 100%.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 7-14. Example: Pareto Chart
90%
120
80%
Frequency of Responses
100
70%
60%
80
50%
60
40%
30%
40
20%
20
10%
0
Untimely operative
dictation
Performed procedures
without adequate
expertise
Delay in reporting
incident
Ignored pathology
reports
Inadequate informed
consent
History of inadequate
documentation
Failure to take
responsibility for
actions
Failure to perform surgery
in a safe manner
No surgical plan/
preoperative findings
Inadequate presurgical
evaluation
No review of patient
care information prior
to surgery
0%
Contributing Causes
One organization used a Pareto chart to rank the frequency of responses of selected root causes provided by team
members investigating a sentinel event involving a wrong-site surgery. The resulting graph can be used to direct and
prioritize improvement efforts.
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| Tools and Techniques
Effective Use Tips
Relations Diagram
►► Have team members take turns placing ideas on
(See Figure 7-15)
the paper so that everyone participates.
►► Remembering the rules for brainstorming, do not
Purpose: To generate understanding of how various aspects
of a problem are connected, including cause-and-effect
relationships
criticize any ideas.
►► Use bold markers for drawing the arrows.
Stages to Use: Identifying proximate causes; identifying
root causes; identifying opportunities for improvement
and draw arrows to represent them. For example, if idea
A has an impact on idea B, draw a line with an arrow
pointing from A to B. Origination notes will indicate
possible causes, destination notes possible effects.
Ultimately each note will have one or more arrows
leading toward and/or away from it.
5. For each note, count the number of arrows to and from it,
and write the totals beside each note. For example, three
arrows to and one arrow from could be written as “3/1.”
6. Examine the totals. Notes with the highest totals will
be the most important ideas to address in resolving the
issue. Those with the highest number of arrows out
represent proximate or possibly even root causes; those
with the highest number of arrows in represent the main
effects. Circle these ideas for further analysis.
Simple Steps to Success:
1. Write a definition of the issue (for example, a problem to
be solved or a solution to be achieved) on a sticky note
and put it at the top of a large sheet of paper such as a
flipchart page on an easel.
2. Give each member of the group a pad of sticky notes and
then brainstorm for ideas about the issue, writing down
one idea per note.
3. One at a time, put each idea on the paper. As an idea is
added, discuss whether it seems related to any other
ideas already on the paper; if so, place it nearby (but not
touching; there should be space between the notes).
4. Determine what the relationships are between related ideas
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Figure 7-15. Example: Relations Diagram—Hospital
6 in 1 out
Scheduled
appointments
0 in 1 out
2 in 2 out
Doctors’
pay level
Emergency
appointments
0 in 3 out
3 in 1 out
Equipment
quality and reliability
Administrative
workload
Support functions
availability
Changes in
scheduled appointments
1 in 3 out
4 in 1 out
Nurse
availability
1 in 5 out
Source: Andersen B, Fagerhaug T. Root Cause Analysis: Simplified Tools and Techniques, 2nd ed. Milwaukee. ASQ Quality Press, 2006.
Reproduced by permission.
A relations diagram like the one shown here can be helpful in understanding the relationships between ideas.
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| Tools and Techniques
Effective Use Tips
Run Chart
►► Be sure that the units and scale used in the
(See Figure 7-16)
chart present an accurate picture of the variation
in order to avoid creating a distorted picture of
the problem.
Purpose: To provide an overview of the variation in the
performance of a process
►► Create a hypothesis as to the cause of any
excessive variation.
Stages to Use: Identifying proximate causes; identifying
opportunities for improvement; implementing and monitoring improvements
►► Interview the responsible staff members to
determine the actual cause of excessive variation.
►► Repeat the process and compare performance
and levels of variation on an ongoing basis.
Simple Steps to Success:
1. Select appropriate units by which to measure variation.
This will be your vertical or y-axis.
2. Select appropriate units of time over which to measure the
variation. This will be your horizontal or x-axis.
3. Gather the data—a minimum of 10 data points.
4. Plot variation on the vertical axis along the horizontal time
line in the sequence in which it was collected.
5. Calculate the mean or median (whichever the data set
indicates to be appropriate) and draw a horizontal line at
that value crossing the graph.
Figure 7-16. Run Chart
ED Wait Time: Average per Patient
140
135
Minutes
130
125
120
115
110
105
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
Weeks
Source: Agency for Healthcare Research and Quality. Advanced Methods in Delivery System Research—Planning, Executing, Analyzing,
and Reporting Research on Delivery System Improvement. Webinar #2: Statistical Process Control. Jul 2013. Accessed Jul 12, 2017. http://
www.ahrq.gov/professionals/prevention-chronic-care/improve/coordination/webinar02/index.html.
This run chart depicts the weekly variation in emergency department wait times, a change analysis that compared the
conditions that led to above average and below average wait times might yield opportunities for process improvement.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Effective Use Tips
Scatter Diagram
►► A scatter diagram can be used when trying to
(Synonym: scattergram)
(See Figure 7-17)
determine whether the two variables are related,
such as when identifying potential root causes of
problems, after brainstorming causes and effects
or using a tool such as a fishbone diagram, when
determining whether two effects that appear to be
related both occur with the same cause, or when
testing for autocorrelation before constructing a
control chart.
Purpose: To display the correlation—not necessarily the
cause-and-effect relationship—between two variables
Stages to Use: Implementing and monitoring
improvements
►► Select two variables with a suspected relationship
Simple Steps to Success:
(for example, delays in processing tests and total
volume of tests to be processed).
1. Decide which two variables are to be tested.
2. Gather and record paired samples of each of the variables
on a data sheet.
3. Draw the horizontal (the independent variable) and
vertical axis (the dependent variable).
4. Plot the variables on the graph along the horizontal axis
and the vertical axis. If a value is repeated, circle that
point as many times as necessary.
5. Look at the pattern of points for a relationship. Interpret
the completed diagram and identify the correlation,
or relationship, between the two variables. If the data
clearly form a line or a curve, it strongly indicates
a correlation. If they don’t, further regression or
correlation analysis is needed.
►► Use the horizontal (x) axis for the variable you
suspect is the cause and the vertical (y) axis for
the effect.
►► Construct the graph so that values increase while
moving up and to the right of each axis.
►► The more the clusters form a straight line (which
could be diagonal), the stronger the relationship
between the two variables.
►► If points cluster in an area running from lower left
to upper right, the two variables have a positive
correlation. This means that an increase in y may
depend on an increase in x; if you can control x,
you have a good chance of controlling y.
►► If points cluster from upper left to lower right, the
variables have a negative correlation. This means
that as x increases, y may decrease.
►► If points are scattered all over the diagram, these
variables may not have any correlation. (The
effect, y, may be dependent on a variable other
than x.)
►► Remember, if the diagram indicates a
relationship, it is not necessarily a cause-andeffect relationship.
►► Be aware that even if the data do not appear to
have a relationship, they may be related.
►► Although scatter diagrams cannot prove a causal
relationship between two variables, they can offer
persuasive evidence.
136
This scatter diagram compares two variables associated with self-administration errors—the number of medications prescribed and the ages of the
patients involved. As might be expected, the clustering of points shows that the older the patient, the higher the number of medications involved in care.
Figure 7-17. Example: Scatter Diagram
CHAPTER 7
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| Tools and Techniques
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Effective Use Tips
SIPOC Process Map
►► Use a cross-functional team to create the SIPOC
(See Figure 7-18; or, a SIPOC template is available
in the e-book DOWNLOAD or on the flash drive.)
process map.
►► Follow one of the key rules of brainstorming
while going through the steps to create the
SIPOC process map: Allow ideas to be expressed
without judgment or critique.
Purpose: To identify the basic elements or variables in
a process among suppliers, inputs, process, outputs, and
customers (SIPOC)
Stages to Use: Identifying improvement opportunities
internal (another department in the organization) or
external (patients).
5. Identify and list the inputs—that is, the information,
materials, or personnel—needed for the process to produce
the outputs.
6. Identify and list the suppliers of the inputs—that is,
the individuals or organizational groups that provide
the inputs.
7. If needed, make further refinements, for example, by
rewording, combining, or moving the items listed within
each column.
Simple Steps to Success:
1. Create a table with five columns labeled suppliers, inputs,
process, outputs, and customers.
2. List four or five steps in the process column (center) of the
SIPOC process map.
3. Identify and list the outputs—that is, the products or
services being offered to the customers—that result from
this process.
4. Identify and list the customers—that is, the people who
are to receive and use the outputs. Customers may be
SIPOC Tool
Figure 7-18. SIPOC Tool: Daily Insulin Management
Process: Daily Insulin Management
Supplier
Patient
Admitting physician
Attending physician(s)
EMR
Nurse(s)
Patient
Attending physician(s)
Testing device
Nurse(s)
Tech
Attending physician
Nurse(s)
Pharmacy
Dietary
Nurse(s)
Tech
Patient
Dietary
Nurse(s)
Tech
Patient
Attending physician
Nurse(s)
Pharmacy
Tech
Input
Process Step
Output
Customer
Clinical information
Insulin order set
Confirm existing insulin order set
Orders for patient care
Patient
Attending physician(s)
Nurse(s)
Testing sample
Testing device
Target range
Test patient blood glucose level
Testing sample
Insulin
Insulin dosing level
Order set
Lab
Testing device
EMR
Nurse
Tech
Administer appropriate dose of insulin
Administered insulin dose
Blood glucose change
Patient
Standing orders
Meal
Confirm patient receives appropriate meal
Patient meal
Patient
Patient meal
Meal consumed by patient
Blood glucose change
Completed meal
Patient
Blood glucose readings
Standing orders
Insulin order set
Testing device
Target range
Correctional insulin dosing as necessary
Administered insulin dose
Blood glucose change
Patient
This sample SIPOC chart shows the process of daily insulin management broken into its component steps. At each
step of the process, the chart shows the suppliers, inputs, outputs, and customers associated with that step.
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Effective Use Tips
Stakeholder Analysis
►► Consider stakeholders at all levels, including both
(See Figure 7-19; or, a stakeholder analysis
template is available in the e-book DOWNLOAD or
on the flash drive.)
salaried and hourly employees.
►► If employees involved in the project are unionized,
meet with the union representative to explain the
purpose of the project.
Purpose: To gauge the level of support from key people
involved in a process change
►► Remember that while full support is ideal, not
all stakeholders need to be at the same level of
support for the project as a whole to succeed.
Stages to Use: Implementing and monitoring
improvements
►► On a scale of 1 to 10, a value of 1 represents
low support and 10 represents high support.
Another possible type of scale uses zero (0) as a
midpoint, representing neutral feelings about the
project. A positive 1 or 2 (+1, +2) indicates mild or
strong support, respectively, while a negative 1 or
2 (-1, -2) represents mild or strong resistance.
Simple Steps to Success:
1. Obtain a project charter.
2. Based on the project charter, identify potential
stakeholders—that is, individuals who play a role in the
project. Create a grid with column headings on the left
side for the names and roles of these stakeholders. (Also
allow space in the grid for at least three columns on the
right side, to be filled in during subsequent steps.) Row
by row, enter the name and role of each stakeholder.
3. Through focus groups or interviews, determine the level of
support (also known as buy-in) that each stakeholder shows
for the project. Assign numerical values to reflect each
person’s level of support. In the first of the right-side
columns, fill in the level of support shown.
4. Determine the level of support needed from each
stakeholder for the project to succeed. Assign numerical
values, using the same scale as in the previous step, and
place them in the second of the right-side columns.
5. Calculate the “gap” between actual and needed support.
Subtract the number in the columns from step 3 from
►► Using the 1-to-10 scale, if the gap number is
0, then the interests of the given stakeholder
are perfectly aligned with the objectives of the
process—congratulations! But more likely, the
number will be greater than 0.
the number in the column from step 4 and place it
in the third of the right-side columns. The higher the
number, the greater the discrepancy between support
needed and support shown.
6. Develop a corrective action plan if needed to increase
the level of support based on the stakeholder analysis.
An optional column (shown at the far right in Figure
7-19) may be added to the grid to indicate the strategy
called for.
139
The stakeholder analysis chart above lists the stakeholders in the relevant improvement project, along with their
perceived level of buy-in to the project, the level of buy-in needed for success, and the gap between. At the far right
the project owner has listed strategies for closing the buy-in gap for each stakeholder.
Figure 7-19. Example: Stakeholder Analysis
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
140
CHAPTER 7
| Tools and Techniques
Effective Use Tips
Standard Work
►► Identify individuals who need to be involved.
(See Figure 7-20; or, a standard work template
is available in the e-book DOWNLOAD or on the
flash drive.)
►► Strive for balance in the work required by
each individual.
►► Encourage those involved to think of standard
work as “the right way—every time.”
Purpose: To create a logical work flow with a minimum
of waste
►► Determine necessary tools and
information required.
Stages to Use: Implementing and monitoring
improvements
►► Decide how long the process should take.
►► Identify expected results.
►► Don’t mistake work instructions with standard
Simple Steps to Success:
operating procedures. Simply put, procedures
tell you who does what and when, whereas work
instructions tell you how to do something.
1. Document the existing process steps for each
individual involved.
2. Identify which steps are waste—that is, they are of no
value to the patient.
3. Measure takt time (the rate of patient demand) and
cycle time (the time it takes to complete one cycle of
an operation).
4. Determine the optimum sequence of work steps for each
individual involved in the process.
5. Create a standardized work chart and use it to train staff
to follow the improved process.
6. Implement changes in the process to reflect the
optimum sequence.
7. Monitor the revised process and measure for success.
8. If the changes are deemed successful, standardize the
new process.
141
142
Process Steps
•
Notes
Standard Work
in Process
Key Safety
Step
+
Check
Critical Step
Takt Time:
Key
▼
Recorded By:
Revision
Date:
Add picture(s) that assist
with build – pictures used
can show entire operation
layout or finished service
at this station.
◆♦ Operation Layout
Option Time
Quality
Check
Date:
Dept./Unit:
Cycle Time:
The above worksheet can be used to create a logical work flow with a minimum of waste.
21
20
19
18
17
16
15
14
13
12
11
10
9
8
7
6
5
4
3
2
1
Step
Key:
Process Name:
Figure 7-20. Example: Standard Work
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
CHAPTER 7
| Tools and Techniques
Effective Use Tips
Value Stream Mapping
►► Make sure the team understands the goal
(See Figure 7-21)
(for example, reduce cycle time, reduce resources,
reduce waste, design for better quality and
productivity).
Purpose: To help health care organizations operate successfully by eliminating, or at least minimizing activities that
do not add value—that is, any steps in a process that do not
contribute to a patient’s experience of value
►► Keep the focus on the patient in any attempt to
discern the value of a step in the process.
►► Keep the value stream practical—map at the
highest level possible.
Stages to Use: Identifying proximate causes; identifying
opportunities for improvement; implementing and monitoring improvements
►► Choose and use the correct tools.
►► Provide advanced education to leaders.
►► Explain the purpose of the walk-through to unit,
section, or department staff.
Simple Steps to Success:
►► Communicate progress and results throughout
1. Break down and analyze the entire value chain to calculate
the value delivered by each process area, as perceived by
the patient. This task involves having a cross-functional
team literally walk through each step of the process,
talking with workers in the value stream and taking
measurements of the time it takes to do the work and
the time spent waiting for the next step.
2. Map the various steps in their respective places according
to value delivered. Consider those areas that do not
contribute value waste and either minimize or eliminate
them. The remaining elements form the foundation for
developing a true patient-centric value chain.
3. Create a smooth and efficient process flow between the
value-added steps identified to transform the chain into a
value stream for the organization. The increase in flow will
the organization.
ultimately improve lead times and eliminate “bullwhip”
effects, creating maximum efficiency and productivity.
4. After establishing the true value stream, deliver services in
alignment with actual patient demand (that is, “pulled”
along by the patient according to the patient’s timetable
of need) and not by assumptions or arbitrary forecasts
(that is, “pushed” onto the patient by the organization
on a timetable set by the organization).
5. Apply the principle of continuous improvement to the
initiative. Ongoing process improvement is absolutely
key to sustaining a competitive edge.
143
144
5 minutes
CT=5 minutes
Check In
15 minutes
Wait for Phlebotomist
15 minutes
5 minutes
CT=5 minutes
Draw Sample
Lab tells patient
appointment time
Wait for Phlebotomist
5 minutes
5 minutes
CT=5 minutes
Verify Test
to Perform
for
ime
lab t intment
s
l
l
e
o
T
app
nt's
patie
Lab scheduling
5 minutes
Prepare
sample
to ship
to lab
Patient
4 days
Wait for Results
4 days
This figure shows the current state of a process (a patient driving to the lab and waiting on the result). An organization can
use this to identify and eliminate or minimize activities that do not offer value to a patient’s experience.
35 minutes drive to lab +
10 minutes wait to check in
Wait for Receptionist
10 minutes
Lab
Physician
Requests lab test
for patient
Physician calls patient with results
Value Stream Map of Patient Driving to Lab and Waiting on Lab Result – Current State
Figure 7-21. Example: Value Stream Mapping
20 minutes of valueadded time
4 days + 65 minutes
Non value-added time
CT=5 minutes
Receives Results
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Appendix
Framework for Root Cause Analysis
and Corrective Actions*
Unexpected findings may emerge during the course of the
analysis, or there may be some questions that do not apply
in every situation. For each finding continue to ask “Why?”
and drill down further to uncover why parts of the process
occurred or didn’t occur when they should have. Significant
findings that are not identified as root causes themselves
have “roots.” “Corrective Actions” should be developed for
every identified root cause.
The Joint Commission’s Framework for Root Cause
Analysis and Corrective Action Plan provides an example of
a comprehensive systematic analysis. The framework and its
24 analysis questions are intended to provide a template for
analyzing an event and an aid in organizing the steps and
information in a root cause analysis. (A template for this
framework is available in the e-book DOWNLOAD or on the
flash drive.)
While the online form provides drop-down menus for
many of the form’s cells, the options for these columns are
provided here in the following tables:
• From the Root Cause Analysis section:
–– Root Cause Types: Table A-1 (column 1)
–– Causal Factors/Root Cause Details: Table A-1
(column 2)
• From the Corrective Actions section:
–– Action Strength: Table A-2
–– Measure of Success: Table A-3
–– Sample Size: Table A-4
An organization can use this template to conduct a root
cause analysis or even as a worksheet in preparation of
submitting an analysis through the online form on its
Joint Commission Connect™ extranet site. Fully consider
all possibilities and questions in seeking “root cause(s)”
and opportunities for corrective actions. Be sure to enter a
response in the “Analysis Findings” column for each item.
* Disclaimer: The framework found on Joint Commission Connect™ will
show the most current iteration of this form.
145
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Event Description
When did the event occur?
Date:
Day of the week:
Time:
Detailed Event Description Including Timeline:
Diagnosis:
Medications:
Autopsy Results:
Past Medical/Psychiatric History:
146
Appendix
ROOT CAUSE ANALYSIS
#
Analysis
Questions
Prompts
1
What was
the intended
process flow?
List the relevant process steps as
defined by the policy, procedure,
protocol, or guidelines in effect at the
time of the event. You may need to
include multiple processes.
Examples of defined process steps
may include, but are not limited to:
• Site verification protocol
• Instrument, sponge, sharps count
procedures
• Patient identification protocol
• Assessment (pain, suicide risk,
physical, and psychological)
procedures
• Fall risk/fall prevention guidelines
Note: The process steps as they
occurred in the event will be entered
in the next question.
2
Were there any
steps in the
process that
did not occur as
intended?
Explain in detail any deviation from
the intended processes listed in
Analysis Question #1 above.
3
What human
factors were
relevant to the
outcome?
Discuss staff-related human
performance factors that contributed
to the event.
Examples may include, but are not
limited to:
• Boredom
• Failure to follow established
policies/procedures
• Fatigue
• Inability to focus on task
• Inattentional blindness/
confirmation bias
• Personal problems
• Lack of complex critical
thinking skills
• Rushing to complete task
• Substance abuse
• Trust
Analysis Findings
Root Cause
Types
(Table A-1)
Causal
Factors/
Root Cause
Details
(Table A-1)
continued
147
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
ROOT CAUSE ANALYSIS continued
#
Analysis
Questions
Prompts
4
How did the
equipment
performance affect
the outcome?
Consider all medical equipment and
devices used in the course of patient
care, including automated external
defibrillator (AED) devices, crash
carts, suction, oxygen, instruments,
monitors, infusion equipment,
and so forth. In your discussion,
provide information on the following,
as applicable:
• Descriptions of biomedical checks
• Availability and condition
of equipment
• Descriptions of equipment with
multiple or removable pieces
• Location of equipment and its
accessibility to staff and patients
• Staff knowledge of or education
on equipment, including applicable
competencies
• Correct calibration, setting,
operation of alarms, displays,
and controls
5
What controllable
environmental
factors affected the
outcome?
What environmental factors within
the organization’s control affected the
outcome? Examples may include, but
are not limited to:
• Overhead paging that cannot be
heard in physician offices
• Safety or security risks
• Risks involving activities of visitors
• Lighting or space issues
• The response to this question
may be addressed more globally
in Question #17. This response
should be specific to this event.
6
What
uncontrollable
external factors
influenced the
outcome?
Identify any factors the health
care organization cannot change
that contributed to a breakdown in
the internal process, for example
natural disasters.
7
Were there any
other factors that
directly influenced
this outcome?
List any other factors not
yet discussed.
8
What are the other
areas in the health
care organization
where this could
happen?
List all other areas in which
the potential exists for similar
circumstances. For example:
• Inpatient surgery/outpatient
surgery
• Inpatient psychiatric care/outpatient
psychiatric care
• Identification of other areas within
the organization that have the
potential to impact patient safety in
a similar manner. This information
will help drive the scope of your
action plan.
Analysis Findings
148
Root Cause
Types
(Table A-1)
Causal
Factors/
Root Cause
Details
(Table A-1)
Appendix
ROOT CAUSE ANALYSIS continued
#
Analysis
Questions
Prompts
9
Was staff
properly qualified
and currently
competent for their
responsibilities?
Include information on the following
for all staff and providers involved in
the event. Comment on the processes
in place to ensure staff is competent
and qualified. Examples may include
but are not limited to:
• Orientation/training
• Competency assessment (What
competencies do the staff have
and how do you evaluate them?)
• Provider and/or staff scope of
practice concerns
• Whether the provider was
credentialed and privileged for
the care and services he or
she rendered
• The credentialing and privileging
policy and procedures
• Provider and/or staff
performance issues
10
How did actual
staffing compare
with ideal level?
Include ideal staffing ratios and actual
staffing ratios along with unit census
at the time of the event. Note any
unusual circumstance that occurred
at this time. What process is used to
determine the care area’s staffing
ratio, experience level, and skill mix?
11
What is the
plan for dealing
with staffing
contingencies?
Include information on what the
health care organization does during
a staffing crisis, such as call-ins,
bad weather, or increased patient
acuity. Describe the health care
organization’s use of alternative
staffing. Examples may include, but
are not limited to:
• Agency nurses
• Cross-training
• Float pool
• Mandatory overtime
• PRN pool
12
Were such
contingencies
a factor in this
event?
If alternative staff were used,
describe their orientation to the
area, verification of competency, and
environmental familiarity.
13
Did staff
performance
during the
event meet
expectations?
Describe whether staff performed
as expected within or outside of
the processes. To what extent was
leadership aware of any performance
deviations at the time? What
proactive surveillance processes
are in place for leadership to identify
deviations from expected processes?
Include omissions in critical thinking
and/or performance variance(s) from
defined policy, procedure, protocol,
and guidelines in effect at the time.
Analysis Findings
Root Cause
Types
(Table A-1)
Causal
Factors/
Root Cause
Details
(Table A-1)
continued
149
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
ROOT CAUSE ANALYSIS continued
#
Analysis
Questions
Prompts
14
To what degree
was all the
necessary
information
available when
needed?
Accurate?
Complete?
Unambiguous?
Discuss whether patient assessments
were completed, shared, and
accessed by members of the
treatment team, to include providers,
according to the organizational
processes. Identify the information
systems used during patient
care. Discuss to what extent the
available patient information (for
example, radiology studies, lab
results, or medical record) was
clear and sufficient to provide an
adequate summary of the patient’s
condition, treatment, and response to
treatment. Describe staff utilization
and adequacy of policy, procedure,
protocol, and guidelines specific to the
patient care provided.
15
To what degree
is communication
among participants
adequate?
Analysis of factors related to
communication should include
evaluation of verbal, written, electronic
communication or the lack thereof.
Consider the following in your
response, as appropriate:
• The timing of communication of
key information
• Misunderstandings related
to language/cultural barriers,
abbreviations, terminology, and
so forth
• Proper completion of internal and
external hand-off communication
• Involvement of patient, family, and/
or significant other
16
Was this the
appropriate
physical
environment for
the processes
being carried out?
Consider processes that proactively
manage the patient care environment.
This response may correlate to the
response in Question #6 on a more
global scale. What evaluation tool
or method is in place to evaluate
process needs and mitigate physical
and patient care environmental
risks? How are these process
needs addressed organizationwide?
Examples may include, but are not
limited to:
• Alarm audibility testing
• Evaluation of egress points
• Patient acuity level and setting
of care managed across
the continuum
• Preparation of medication outside
of pharmacy
Analysis Findings
150
Root Cause
Types
(Table A-1)
Causal
Factors/
Root Cause
Details
(Table A-1)
Appendix
ROOT CAUSE ANALYSIS continued
#
Analysis
Questions
Prompts
17
What systems are
in place to identify
environmental
risks?
Identify environmental risk
assessments. Does the
current environment meet
codes, specifications, regulations?
Does staff know how to report
environmental risks? Was there
an environmental risk involved
in the event that was not previously
identified?
18
What emergency
and failure-mode
responses have
been planned and
tested?
Describe variances in expected
process due to an actual emergency
or failure mode response in
connection to the event. Related to
this event, what safety evaluations
and drills have been conducted and
at what frequency (for example, mock
code blue, rapid response, behavioral
emergencies, patient abduction or
patient elopement)? Emergency
responses may include, but are not
limited to:
• Fire
• External disaster
• Mass casualty
• Medical emergency
Failure mode responses may include,
but are not limited to:
• Computer down time
• Diversion planning
• Facility construction
• Power loss
• Utility issues
19
How does the
organization’s
culture support risk
reduction?
How does the overall culture
encourage change, suggestions, and
warnings from staff regarding risky
situations or problematic areas?
• How does leadership demonstrate
the organization’s culture and
safety values?
• How does the organization
measure culture and safety?
• How does leadership address
disruptive behavior?
• How does leadership establish
methods to identify areas of risk
or access employee suggestions
for change?
• How are changes implemented?
Analysis Findings
Root Cause
Types
(Table A-1)
Causal
Factors/
Root Cause
Details
(Table A-1)
continued
151
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
ROOT CAUSE ANALYSIS continued
#
Analysis
Questions
Prompts
20
What are the
barriers to
communication
of potential risk
factors?
Describe specific barriers to effective
communication among caregivers
that have been identified by the
organization. For example, residual
intimidation or reluctance to report
coworker activity.
Identify the measures being taken
to break down barriers (for example,
use of SBAR). If there are no barriers
to communication discuss how this
is known.
21
How does
leadership address
the continuum
of patient safety
events, including
close calls, adverse
events, and
unsafe, hazardous
conditions?
Does leadership demonstrate
accountability for implementing
measures to reduce risk for patient
harm? Has leadership provided for
required resources or training? Does
leadership communicate corrective
actions stemming from any analysis
following reported risks?
22
How can
orientation and
in-service training
be improved?
Describe how orientation and
ongoing education needs of the
staff are evaluated and discuss its
relevance to event (for example,
competencies, critical thinking
skills, use of simulation labs,
evidence-based practice).
23
Was available
technology used
as intended?
Describe variances in the expected
process due to education, training,
competency, impact of human factors,
functionality of equipment, and so on:
• Was the technology designed to
minimize use errors or easy-tocatch mistakes?
• Did the technology work well with
the workflow and environment?
• Was the technology used outside
of its specifications?
24
How might
technology be
introduced or
redesigned to
reduce risks in
the future?
Describe any future plans for
implementation or redesign. Describe
the ideal technology system that can
help mitigate potential adverse events
in the future.
Analysis Findings
152
Root Cause
Types
(Table A-1)
Causal
Factors/
Root Cause
Details
(Table A-1)
Appendix
CORRECTIVE ACTIONS
Root Cause
Types
(Table A-1)
Causal
Factors/
Root Cause
Details
(Table A-1)
Corrective Actions
Action Strength
(Table A-2)
Action Item #1:
Action Item #2:
Action Item #3:
Action Item #4:
Action Item #5:
Action Item #6:
Action Item #7:
Action Item #8:
153
Measure of
Success
(Numerator /
Denominator)
(Table A-3)
Sample Size
(Table A-4)
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
BIBLIOGRAPHY
Cite all books and journal articles that were considered in developing this root cause analysis and action plan.
154
Appendix
TABLE A-1. ROOT CAUSES
Root Cause Types
Causal Factors / Root Cause Details
Communication factors
•
•
•
•
•
•
Environmental factors
• Noise, lighting, flooring condition, and so forth
• Space availability, design, locations, storage
• Maintenance, housekeeping
Equipment/device/supply/
healthcare IT factors
• Equipment, device, or product supplies problems or availability
• Health information technology issues such as display/interface issues (including display of
information), system interoperability
• Availability of information
• Availability of information malfunction, incorrect selection, misconnection
• Labeling instructions, missing
• Alarms silenced, disabled, overridden
Task/process factors
• Lack of process redundancies, interruptions, or lack of decision support
• Lack of error recovery
• Workflow inefficient or complex
Staff performance factors
• Fatigue, inattention, distraction, or workload
• Staff knowledge deficit or competency
• Criminal or intentionally unsafe act
Team factors
• Speaking up, disruptive behavior, lack of shared mental model
• Lack of empowerment
• Failure to engage patient
Management/ supervisory/
workforce factors
•
•
•
•
•
Organizational culture/leadership
• Organizational-level failure to correct a known problem and/or provide resource support
including staffing
• Workplace climate/institutional culture
• Leadership commitment to patient safety
Communication breakdowns between and among teams, staff, and providers
Communication during handoff, transition of care
Language or literacy
Availability of information
Misinterpretation of information
Presentation of information
Disruptive or intimidating behaviors
Staff training
Appropriate rules/policies/procedure or lack thereof
Failure to provide appropriate staffing or correct a known problem
Failure to provide necessary information
Adapted from Department of Defense, Patient Safety Program. PSR Contributing Factors List – Cognitive Aid, Version 2.0. May 2013.
155
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
TABLE A-2. ACTION STRENGTH
Action Strength
Action Category
Example
Stronger Actions
Architectural/physical plant changes
(These tasks require less reliance
on humans to remember to perform
the task correctly.)
Replace revolving doors at the main patient entrance
into the building with powered sliding or swinging
doors to reduce patient falls.
New devices with usability testing
Perform heuristic tests of outpatient blood glucose
meters and test strips and select the most appropriate
for the patient population being served.
Engineering control (forcing function)
Eliminate the use of universal adaptors and peripheral
devices for medical equipment and use tubing/
fittings that can be connected only the correct way
(for example, IV tubing and connectors that cannot
physically be connected to sequential compression
devices [SCDs]).
Simplify process
Remove unnecessary steps in a process.
Standardize on equipment or process
Standardize the make and model of medication pumps
used throughout the institution. Use bar coding for
medication administration.
Tangible involvement by leadership
Participate in unit patient safety evaluations and
interact with staff; support the RCA2 process (root
cause analysis and action); purchase needed
equipment; ensure staffing and workload are balanced.
Redundancy
Use two registered nurses to independently calculate
high-risk medication dosages.
Increase in staffing/decrease in workload
Make float staff available to assist when workloads
peak during the day.
Software enhancements, modifications
Use computer alerts for drug–drug interactions.
Eliminate/reduce distractions
Provide quiet rooms for programming patientcontrolled analgesia (PCA) pumps; remove distractions
for nurses when programming medication pumps.
Education using simulation-based training,
with periodic refresher sessions and
observations
Conduct patient handoffs in a simulation lab/
environment, with after-action critiques and debriefing.
Checklist/cognitive aids
Use pre-induction and pre-incision checklists in
operating rooms. Use a checklist when reprocessing
flexible fiber optic endoscopes.
Eliminate look- and sound-alikes
Do not store look-alikes next to one another in the unit
medication room.
Standardized communication tools
Use read-back for all critical lab values. Use read-back
or repeat-back for all verbal medication orders. Use a
standardized patient handoff format.
Intermediate
Actions
Enhanced documentation, communication
Highlight medication name and dose on IV bags.
Weaker Actions
Double checks
One person calculates dosage, another person
reviews their calculation.
(These tasks rely more on humans
to remember to perform the task
correctly)
Warnings
Add audible alarms or caution labels.
New procedure/memorandum/policy
Remember to check IV sites every 2 hours.
Training
Demonstrate correct usage of hard-to-use
medical equipment.
Reference: Action Hierarchy levels and categories are based on Root Cause Analysis Tools, VA National Center for Patient Safety. Accessed Sep 5, 2017. http://
www.patientsafety.va.gov/docs/joe/rca_tools_2_15.pdf. Examples are provided here.
Source: National Patient Safety Foundation. RCA2 Improving Root Cause Analyses and Actions to Prevent Harm. Boston, MA: National Patient Safety Foundation;
2015. Reproduced with permission.
156
Appendix
TABLE A-3. MEASURE OF SUCCESS
Fraction Part
Defined
Identified
Example
Numerator
The number of events being measured
Ask a specific question—what are
you measuring?
Falls that resulted in hip fractures in
diabetic patients over 70 years of age
Denominator
All the opportunities in which the event
could have occurred
Identify the patient population from
which to collect the information.
The number of diabetic patients on
a unit who are older than 70 years
of age
TABLE A-4. SAMPLE SIZE
Population Size
Sample
Fewer than 30 cases
100% of cases
30 to 100 cases
30 cases
101 to 500 cases
50 cases
Greater than 500 cases
70 cases
The sampling methodology1 was determined using quality assurance sampling methods that determine
the sample size needed to be able to say from a sample of cases that the “defect” rate is less than a
specified amount (here we used 10%) with 95% confidence if no “defects” are found in the sample.2
References
1. Stephens, KS. The Handbook of Applied Acceptance Sampling. ASQ Quality Press Books 2001.
2. Lwanga SK and Lemeshow S. Sample Size Determination in Health Studies: A Practical Manual. World Health Organization, 1991,
15–16
157
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
158
Glossary
A
are allowed to flow freely and participants are asked to
contribute fully and fairly, liberating them to develop a rich
array of creative solutions to the problems they’re facing.
adverse drug event An injury resulting from medical
intervention related to a medication,
adverse event A patient safety event that resulted in harm
to a patient.
C
affinity diagram An illustrative tool used to organize a
large volume of ideas or data into meaningful groups with
logical connections.
care The provision of accommodations, comfort, and
treatment to an individual, implying responsibility for
safety, including care, treatment, service, habilitation, rehabilitation, or other programs instituted by the organization
for the individual served.
aggregate data (measurement data) Measurement data
collected and reported by organizations as a sum or total
over a given time period (for example, monthly, quarterly)
or for certain groupings (for example, health care organization level).
care recipient See patient.
change analysis A study of the differences between the
expected and actual performance of a process. Change
analysis involves determining the root causes of an event by
examining the effects of change and identifying causes.
B
benchmarking Continuous measurement of a process,
product, or service compared to those of the toughest
competitor, to those considered industry leaders, or to
similar activities in the organization to find and implement
ways to improve it. This is one of the foundations of both
total quality management and continuous quality improvement. Internal benchmarking occurs when similar processes
within the same organization are compared. Competitive
benchmarking occurs when an organization’s processes
are compared with best practices within the industry.
Functional benchmarking refers to benchmarking a similar
function or process, such as scheduling, in another industry.
change management A concept that includes many tools
to focus on the human side of change.
check sheet A form used to sort and group data, using
check marks or similar symbols.
close call A patient safety event that did not reach the
patient; also called a near miss or a good catch.
common-cause variation See variation.
complexity A high number of steps and handoffs in
work processes.
brainstorming Brainstorming is a common group
technique for generating many ideas in a short period of
time, where participants have the opportunity to build on
the ideas of others. Brainstorming works best when ideas
comprehensive systematic analysis A process for identifying basic or causal factors underlying variation in performance, including the occurrence or possible occurrence of a
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
sentinel event. A root cause analysis is one type of systematic comprehensive analysis.
error of omission A mistake that occurs as a result of an
action not taken. Examples include a delay in performing
an indicated caesarean section, resulting in a fetal death;
a nurse omitting a dose of a medication that should be
administered; and a patient suicide that is associated with a
lapse in carrying out frequent patient checks in a psychiatric
unit. Errors of omission may or may not lead to adverse
outcomes.
contributing factor A circumstance, action, or influence
that is thought to have played a part in the origin, development, or increased risk of an incident.
control chart A visual representation of tracking progress
over time.
F
corrective action See improvement action.
failure Lack of success, nonperformance, nonoccurrence,
breaking down, or ceasing to function. In most instances,
and certainly within the context of this book, failure is what
is to be avoided. It takes place when a system or part of a
system performs in a way that is not intended or desirable.
corrective action plan The product of the root cause
analysis that identifies the strategies that an organization
intends to implement to reduce the risk of similar events
occurring in the future. The plan should address responsibility for implementation, oversight, pilot testing as appropriate, time lines, and strategies for measuring the effectiveness of the actions.
failure mode and effects analysis (FMEA) A systematic
way of examining a design prospectively for possible ways
in which failure can occur. It assumes that no matter how
knowledgeable or careful people are, errors will occur in
some situations and may even be likely to occur. Synonym:
failure mode, effects, and criticality analysis (FMECA).
coupled system A system that links two or more activities
so that one process is dependent on another for completion.
A system can be loosely or tightly coupled.
direct cause See proximate cause.
fishbone diagram The visual representation to clearly
display the various factors affecting a process. Synonym:
cause-and-effect diagram.
discovery In the legal sense, the required disclosure of
pertinent facts or documents by parties in a legal action or
proceeding.
five whys A problem-solving technique that helps users to
get to the root cause of the problem quickly without statistical analysis by asking the question “Why?” five times.
DMAIC The acronym for Define, Measure, Analyze,
Improve and Control. It is the core of Six Sigma methodology that describes its problem-solving sequence.
flowchart A pictorial summary that shows with symbols
and words the steps, sequence, and relationship of the
various operations involved in the performance of a function or a process.
D
E
function A group of processes with a common goal.
elopement The unauthorized departure of a patient from
a controlled care setting.
G
error of commission A mistake that occurs as a result of
an action taken. Examples include a drug being administered at the wrong time, in the wrong dose, or using the
wrong route; surgeries performed on the wrong side of the
body; and transfusion errors involving blood crossmatched
for another patient.
Gantt chart A graphical depiction of the time frame for a
long-term, complex project, including the numerous phases
of the project, person(s) responsible, and targeted completion dates, used to help the project team gauge its progress.
160
Glossary
H
M
hazardous condition A circumstance (other than a
patient’s own disease process or condition) that increases
the probability of an adverse event.
malpractice Improper or unethical conduct or unreasonable lack of skill by a holder of a professional or official
position; often applied to physicians, dentists, lawyers, and
public officers to denote negligent or unskillful performance of duties when professional skills are obligatory.
histogram A visual representation displaying the
­distribution of the data within a range of values.
measurement The process of collecting and
aggregating data.
I
improvement action A solution required to prevent a
problem from occurring or recurring due to the same root
cause or interaction(s) of root causes. Synonym: corrective
action.
medication error A preventable event that may cause or
lead to inappropriate medication use or patient harm while
the medication is in the control of the health care professional, patient, or consumer. Such events may be related
to professional practice, health care products, procedures,
and systems, including prescribing; order communication; product labeling, packaging, and nomenclature;
compounding; dispensing; distribution; administration;
education; monitoring; and use.
incident report A written report, usually completed by a
nurse and forwarded to risk management personnel, that
describes and provides documentation for any unusual
problem, incident, or other situation that is likely to lead to
undesirable effects or that varies from established policies
and procedures.
multivoting A tool used to narrow down a broad list of
ideas (such as those generated through brainstorming) to
those that the team members collectively find most worthy
of immediate attention.
indicator 1. A measure used to determine, over time,
performance of functions, processes, and outcomes. 2. A
statistical value that provides an indication of the condition
or direction over time of performance of a defined process
or achievement of a defined outcome.
N
no-harm event A patient safety event that did not result
in harm to the patient.
individual served See patient.
operational definition A description of a concept
demonstrated by the process that includes a means of
measurement. An operational definition may be used
during the creation of a project charter, when defining a
customer’s requirements, when collecting data, or when
analyzing capability.
L
latent condition A condition that exists as a consequence
of management and organizational processes and poses
the greatest danger to complex systems. Latent conditions
can be identified and corrected before they contribute to
mishaps.
O
Lean Six Sigma A patient-focused health care management philosophy that promotes various proven methods
of stabilizing, standardizing, and simplifying work processes
to reduce waste and improve quality of care. Lean Six Sigma
practices contribute to reducing adverse events, increasing
patient perception of high-quality care, raising levels of
staff retention and satisfaction, and saving the
organization money.
ordering See prescribing.
outcome measure A tool used to assess data that indicates
the results of performance or nonperformance of a function
or procedure.
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P
process A goal-directed, interrelated series of actions,
events, mechanisms, or steps that transform inputs
into outputs.
Pareto chart A vertical bar graph that displays the data
being studied in order from largest to smallest.
patient The terms individual served, patient, and care recipient all describe the individual, client, consumer, or resident
who actually receives health care, treatment, and/or services.
process measure An intermediate indicator of the success
of an intervention.
proximate cause A system failure that naturally and
directly produces a consequence. It is the superficial or
obvious cause for an occurrence. Treating only the symptoms, or the proximate special cause, may lead to some
short-term improvements but does not prevent the variation from recurring.
patient safety event An event, incident, or condition that
could have resulted or did result in harm to a patient. See
also adverse event, near miss, sentinel event.
policy A principle or method that is developed for
the purpose of guiding decisions and activities related to
governance, management, care, treatment, and services.
A policy is developed by organization leadership, approved
by the governing body of the organization, and maintained
in writing.
Q
quality improvement An approach to the continuous
study and improvement of the processes of providing health
care services to meet the needs of individuals and others.
Synonyms: continuous quality improvement, continuous
improvement, organizationwide performance improvement,
and total quality management.
practice guidelines Tools that describe a specific procedure or processes found, through clinical trials or by
consensus opinion of experts, to be the most effective in
evaluating and/or treating a patient, resident, or individual
served who has a specific symptom, condition, or diagnosis.
Synonyms: clinical practice guideline, practice parameter,
protocol, preferred practice pattern, and guideline.
quality of care The degree to which care, treatment, and
services for individuals and populations increases the
likelihood of desired health outcomes. Considerations
include the appropriateness, efficacy, efficiency, timeliness,
accessibility, and continuity of care; the safety of the care
environment; and the individual’s personal values, practices,
and beliefs.
practitioner Any individual who is licensed and qualified
to practice a health care profession (for example, physician,
nurse, social worker, clinical psychologist, or respiratory
therapist) and is engaged in the provision of care, treatment, or services.
R
prescribing The process of a licensed independent
practitioner or prescriber transmitting a legal order or
prescription to the organization directing the preparing,
dispensing, and administering of a specific medication to a
specific individual. It does not include requisitions for
medication supplies.
referral The act of sending an individual (1) from one
clinician to another clinician or specialist, (2) from one
setting or service to another, or (3) by one physician
(the referring physician) to another physician(s) or other
resource, either for consultation or care.
relations diagram A tool used to generate understanding
of how various aspects of a problem are connected,
including cause-and-effect relationships.
procedure 1. A series of steps taken to accomplish a
desired end, as in a therapeutic, cosmetic, or surgical procedure. 2. A unit of health care, as in services and procedures.
A procedure is not necessarily developed by organization
leadership, approved by the governing body of the organization, and maintained in writing.
relevance The applicability and/or pertinence of the
indicator to its users and customers. For Joint Commission
purposes, face validity is subsumed in this category.
162
Glossary
reliability The capability of an indicator to accurately and
consistently identify the events it is designed to identify
across multiple health care settings.
sentinel event 1. For purposes of Joint Commission
accreditation: A patient safety event (not primarily related
to the natural course of the patient’s illness or underlying
condition) that reaches a patient and results in death,
permanent harm, or severe temporary harm. Sentinel events
are a subcategory of adverse events. 2. For purposes of Joint
Commission International accreditation: An unanticipated
occurrence involving death or serious physical or psychological injury—serious physical injury specifically includes
loss of limb or function.
resilience The degree to which a system continuously
prevents, detects, mitigates, or ameliorates hazards or
incidents.
risk points Specific points in a process that are susceptible
to failure or system breakdown. They generally result from
a flaw in the initial process design, a high degree of dependence on communication, nonstandardized processes, and/
or failure or absence of backup.
services Structural divisions of an organization, its
medical staff, or its licensed independent practitioner staff.
root cause A fundamental reason for the failure or inefficiency of a process.
SIPOC process map A high-level process map that
depicts suppliers, inputs, process, outputs, and customers.
root cause analysis A process for identifying the basic
or causal factor(s) underlying variation in performance,
including the occurrence or possible occurrence of a
sentinel event.
Six Sigma A statistical model that measures a process
in terms of defects. Six Sigma allows an organization
to achieve quality by using a set of strategies, tools, and
methods designed to improve processes so that less than 3.4
defects (that is, errors or unexpected or undesired results)
exist for every million opportunities.
run chart A tool for measuring variation in the performance of a given task or process.
special-cause variation See variation.
S
staff As appropriate to their roles and responsibilities, all
people who provide care, treatment, and services in the
organization, including those receiving pay (for example,
permanent, temporary, and part-time personnel, as well
as contract employees), volunteers, and health profession
students. The definition of staff does not include licensed
independent practitioners who are not paid staff or who are
not contract employees.
scatter diagram A illustration graphically plotting pairs
of numerical data to display the possible relationship—not
necessarily a cause-and-effect relationship—between one
variable and another.
scientific method The systematic process of determining
what is known about a problem, deciding what needs to be
changed, forming a hypothesis for implementing change,
testing the hypothesis, and evaluating the result.
stakeholder analysis A tool used to ascertain the level of
commitment from key people involved in a process change.
seclusion The involuntary confinement of an individual in
a room alone, for any period of time, from which the individual is physically prevented from leaving. Seclusion does
not include involuntary confinement for legally mandated
but nonclinical purposes, such as the confinement of a
person who is facing serious criminal charges or who is
serving a criminal sentence.
standard A principle of patient safety and quality of care
that a well-run organization meets. A standard defines the
performance expectations, structures, or processes that must
be substantially in place in an organization to enhance the
quality of care, treatment, or services.
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
standard deviation The square root of the variance.
Standard deviation shows how much variation or dispersion
from the average exists.
utility systems Building systems that provide support
to the environment of care, including electrical distribution
and emergency power; vertical and horizontal transport;
heating, ventilating, and air-conditioning (HVAC);
plumbing, boiler, and steam; piped gases; vacuum
systems; and communication systems, including data
exchange systems.
standard work Sequence of repeatable tasks that an operator performs. Creating standard protocols, procedures, and
workflow establishes the right way to fulfill customer (or
patient) demand with the least amount of waste or variability. Examples of standard work include standard operating procedures, policies, templates, models, and guides.
V
value stream mapping A tool used to help health care
organizations operate successfully by eliminating, or at least
minimizing, non-value-added activities—that is, any steps
in a process that do not contribute to a patient’s experience
of value.
suicide The act of ending one’s own life voluntarily
and intentionally.
survey A key component in the accreditation process,
whereby a surveyor(s) conducts an on-site evaluation of an
organization’s compliance with Joint Commission or Joint
Commission International accreditation requirements.
variation The differences in results obtained in measuring
the same phenomenon more than once. Excessive variation
frequently leads to waste and loss, such as the occurrence
of undesirable patient health outcomes and increased cost
of health services. The sources of variation in a process
over time can be grouped into two major classes: common
causes and special causes. Common-cause variation (also
called endogenous-cause variation or systemic-cause variation)
in a process is due to the process itself and is produced
by interactions of variables of that process inherent in
all processes, not a disturbance in the process. It can be
removed only by making basic changes in the process.
Special-cause variation (also called exogenous-cause variation
or extrasystemic cause variation) in performance results from
assignable causes. Special-cause variation is intermittent,
unpredictable, and unstable. It is not inherently present in
a system; rather, it arises from causes that are not part of the
system as designed.
surveyor For purposes of Joint Commission accreditation,
a licensed physician, surgeon, podiatrist, dentist, nurse,
physician assistant, administrator, social worker, psychologist, behavioral health care professional, or any other
health care professional who meets The Joint Commission’s
surveyor selection criteria, evaluates compliance with
accreditation requirements, and provides education and
consultation regarding compliance with accreditation
requirements to surveyed organizations or systems.
U
underlying cause The systems or process cause that allows
for the proximate cause of an event to occur. Underlying
causes may involve special-cause variation, common-cause
variation, or both and may or may not be root causes.
164
Index
A
on proximate causes, 65
Breakaway compliant fixtures, 59, 62, 72, 93, 97, 105
Accountability, 9
Accreditation
reporting status during sentinel event review process,
27–28
safety culture in, 35
sentinel event requirements in, 1, 4, 7, 18, 21,
28–29, 31
survey process in, 42, 46
Action plan, 85–108. See also Corrective action plan
Active failures, 7, 8
Ad hoc team members, 50
Adverse drug events, 159
Adverse events, v, 17–18, 159
frequency/severity matrix on, 4, 5–6
range of, 17–18
response to, 19
risk of recurrence, 10, 11
state reporting requirements on, 25
variation as factor in, 8
Affinity diagrams, 65, 68, 85, 112, 113–114, 159
Aggregate data, 29, 71–72, 106, 159
and continuous variable indicators, 71–72
and rate-based indicators, 71
American Society for Healthcare Risk Management, 37
Assessment process factors, 68
Audio recordings, 58, 59
C
Care, ix, 159
in early response to sentinel event, 36–37
quality of, 162
recipients of, ix, 162. See also Patients
Cause-and-effect relationships
fishbone diagrams on, 112. See also Fishbone diagrams
relations diagrams on, 133–134, 163
Change analysis, 65, 67, 75, 112, 116, 159
Change management, 112, 117
in corrective actions, 85, 103–104
definition of, 159
in Robust Process Improvement, 4, 111
Change process, 100–101
resistance to, 100
stages of, 101, 103–104
Check sheets, 112, 118, 159
Clinical practice guidelines, 162
Close calls, 159
contributing and protective factors in, vi
frequency/severity matrix on, 4, 5–6
as learning opportunity, 3–4, 19
policy evaluation checklist on, 34
problem statement on, 53
root cause analysis of, vi, 2, 4, 7, 19, 84
as signal of risk, vi, 18
Comment questions, 60
Commitment to excellence, 4
Common-cause variations, 8, 9, 76, 164
Communication
as causal factor, 68, 81, 155
contact list for, 37, 39–41
on corrective actions, 106–108
disclosure checklist on, 43–45
B
Baseline data, 70, 102, 104
Benchmarking, 106, 159
Blame
and creating no-blame environment, 52, 53, 60, 83
fear of, 58
Brainstorming, 67, 112, 115, 159
on contributing factors, 68
on corrective actions, 85, 95, 102, 115
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
effective strategies in, 45
in interviews, 61
on investigation progress, 37–42, 56
with patients and families, 42, 43–45, 68
storytelling strategy in, 108
in team approach, 52–53, 56
Communication and Optimal Resolution (CANDOR), 42
Complexity, 159
risk for system failures in, 54
Comprehensive Accreditation Manual, 19, 36
Comprehensive systematic analysis, v, 23, 159–160
confidentiality of, 28
requirement for, 1, 7, 18, 19, 24, 27, 28
root cause analysis in, 28
Confidentiality issues
in communication with media, 37
developing policies on, 33, 34
in interviews, 61
Joint Commission and JCI responsibility in, 28, 29,
30, 33
legal concerns in, 24–26, 33, 59
in nonpunitive process, 83, 86
in team approach, 53
Contemplation stage in change process, 101
Continuous quality improvement, 30, 162
Continuous variable indicators, 71
Contributing factors, 9, 11, 160
differentiated from root causes, 79, 82
evaluation checklist on, 82
identification of, 29, 66–69
Control charts, 102, 106, 112, 119–120, 160
Core team members, 50, 51
Corrective action plan, viii, 4, 7, 10–16, 23, 27,
85–108, 160
acceptability of, viii, 10–11, 28, 33, 101, 102
confidentiality of, 28
evaluation of, 95–97
framework for, vii, 13, 28, 66, 76, 86, 145–157
goals, scope, and activities defined in, 97
implementation of, 13, 16, 101–108
requirement for, 28, 30
submission of, 28
time allowed for, 30
what, how, when, who, and where issues in, 13, 97–100
Corrective actions, viii, 85–108
aggregate external databases on, 106
barriers to, 96, 106, 107
benchmarks on, 106
categories of, 92
challenges in, 10, 106, 107
change process in, 100–101, 103–104, 117
communication of results in, 106–108
definition of, 92, 161
DMAIC model in, 102, 103, 104, 111–113
expectations in, 97
failure mode and effects analysis of, 95, 101, 121
follow-up on, 10, 29, 33, 106
hierarchy of, 93, 94
identification of, 93
immediate changes in, 72–73
implementation of, 96, 101–108
individuals responsible for, 97, 100
internal comparisons of, 106
location of, 100
measurements on, 70, 95, 97, 102, 103, 104, 105
mistake proofing in, 92–95
organizational processes in, 96
performance targets in, 106
pilot test of, 101
problems and remedies in, 106, 107
proposed, evaluation of, 95–97, 101
resources required for, 96
risk reduction strategies in, viii, 4, 7, 10, 27, 28, 86–92
scientific method in, 95, 102
strength of, 93, 94, 156
time frame for, 30, 96, 97, 98–99, 100
what, how, when, who, and where issues in, 97–100
Correlation, scatter diagrams on, 136
Costs in sentinel event reporting, 27
Coupled systems, 54, 160
Culture, organizational, 31, 33–35, 36, 69, 77, 155
hierarchies in, 54
safety in, 3, 31, 35–36
D
Data collection. See Information and data collection
Death in sentinel events, 1, 8, 18, 20
in common and special cause variations, 9
in error of omission, 19
frequency/severity matrix on, 5
JCI policy on, 1, 7, 29, 32
review of, 19
Decision making in team, 51
Defensiveness in interviews, 60, 61
Define, measure, analyze, improve, and control (DMAIC),
102, 103, 104, 111–113, 160
166
Index
Direct causes, 9, 66. See also Proximate causes
Disclosable information, 27–28, 33, 37, 42
checklist on, 43–45
Discovery, 33, 59, 160
Disease transmission as sentinel event, 7, 29
DMAIC process, 102, 103, 104, 111–113, 160
Documentation
contact information in, 37, 39–41
as evidence, 37, 59, 62, 63
incident reports in, 37, 38, 161
methods of, 58–59
Drawings for recording information, 58, 59
Ethical issues in disclosure of errors, 42
Event investigation. See Problem investigation
Evidence in sentinel events
documentary, 37, 59, 62, 63
physical, 59, 62
preservation of, 37, 62
Excellence, commitment to, 4
Exogenous-cause (special-cause) variations, 8–9, 76, 164
Expectations in corrective actions, 97
Exploratory questions, 60
Extrasystemic cause (special-cause) variations, 8–9, 76, 164
F
E
Facilitator role in team approach, 50, 52, 56
Fail-safe design, 88
Failure mode, effects, and criticality analysis (FMECA),
92, 160
Failure mode and effects analysis (FMEA), 112, 121–122
of corrective actions, 85, 95, 101
definition of, 160
as proactive process, vii, 4, 92, 121–122
root cause analysis compared to, 92
root causes identified in, 4, 92
Failures, v, 68
active, 7, 8
in complex systems, 54
contributing factors in, 9
definition of, 160
root causes in, 4
Falls
from bed, 9, 58, 66
multiple root causes in, 9, 66, 83
Sentinel Event Database on, 83
Family, communication with, 42, 43–45, 68
Fear of blame, 58
Federal reporting requirements, 25
Fire, 20
Fishbone diagrams, 67, 75, 112, 123–124
on corrective actions, 95, 102
definition of, 160
on multiple problems, 79
on proximate causes, 65
on suicide event, 93, 124
Five whys, 67, 160
Flow, in process, 113
Flowcharts, 66, 75, 112, 125–126, 160
on corrective actions, 85, 95, 102
on medication errors, 126
Elopement, 20, 48, 160
corrective actions in, 93
information collected on, 59
literature review on, 62
reporting mechanism for, 56
team investigation of, 51, 56, 93
Emergency department wait times, run chart on, 135
Endogenous-cause (common cause) variations, 8, 9,
76, 164
Environmental factors, viii, 67, 69, 77, 155
checklist on, 81
in elopement, 59, 62
identification of, 68
in medication errors, 15
questions in analysis of, 78
in suicide event, 59, 79, 93
Equipment factors, viii, 18, 67, 68, 69, 155
categories of, 77
identification of, 68
in medication errors, 15, 59
preservation of evidence on, 37, 62
Errors, 19, 86, 87
of commission, 19, 160
in communication, 68
communication with patient and family on, 42
compared to sentinel events, 32
in high-reliability organizations, v, 2
learning from, 3
medication-related. See Medication errors
of omission, 19, 160
proximate and underlying causes of, 7
root cause analysis of, vii, 1, 2
Swiss chess model of, 2, 3, 86
variation as factor in, 1
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
on process problems, 67
on proximate causes, 65, 125
Follow-up activities, 29, 33
in corrective actions, 10, 29, 33, 106
in root cause analysis, 10, 12–13
Follow-up questions, 60, 61
Forcing functions, 86
Foreign object, unintended retention of, 20, 83
Framework for Root Cause Analysis and Corrective Action
Plan, vii, 13, 28, 66, 76, 86, 145–157
Frequency/severity matrix on safety-related problems,
4, 5–6
Functions
definition of, 93, 160
forcing functions in risk reduction, 86
Improvement actions, 85–108. See also Corrective actions
Incident reports, 37, 38, 161
Indicators
definition of, 70, 161
selection of, 70, 71, 72, 105
Individual served, ix, 162. See also Patients
Infant abductions, 7, 29
problem statement on, 53
risk points and risk reduction strategies in, 54, 88, 91
Information and data collection, 13, 58–63
baseline data in, 70, 102, 104
checklist on, 72, 74
on close calls, 18
confidentiality in, 33, 53, 59
on corrective actions, 105–106
criteria-based review of, 79
in DMAIC model, 102, 103, 104, 111
in high reliability organizations, 3–4
interviews in, 59–61
legal issues in, 59
literature review in, 62–63
measurements in, 69–72. See also Measurement
preservation of evidence in, 37
on proximate and underlying causes, 66–72
recording methods in, 58–59
team approach to, 48, 53, 58–63
Information-related factors, 67, 77
checklist on, 80
identification of, 68
in medication errors, 15
questions in analysis of, 78
in suicide event, 77, 79
team investigation of, 50, 77
Information technology, 56, 69, 155
Institute for Safe Medication Practices, 92
Institute of Medicine, v
Insulin management, SIPOC process map on, 138
International Patient Safety Goals, 31
Interviews, 58, 59–61
G
Gantt charts, 75, 112, 127
on corrective actions, 85, 97, 98–99, 127
definition of, 160–161
on proximate causes, 65, 127
Good catches, 19, 159. See also Close calls
Group interviews, 60, 61
H
Hand hygiene, 76
Hazardous conditions, 18, 19, 161
High-reliability organizations and industries, v, 2–4, 86, 88
safety culture in, 35
Histograms, 102, 112, 128
on corrective actions, 85, 106, 128
definition of, 161
on root causes, 75
Human factors, viii, 11, 18, 67
categories of, 77
in failure of corrective actions, 106, 107
identification of, 68
in medication errors, 15
Human resources issues, 59, 77
checklist on, 80
evidence on, 62
questions in analysis of, 78
risk reduction strategies in, 90
in suicide event, 77, 79
J
The Joint Commission
acceptance of corrective action plan by, 10–11, 101
on comprehensive systematic analysis, 1, 7, 19
on failure mode and effects analysis, 92
Framework for Root Cause Analysis and Corrective
Action Plan of, 13, 28, 66, 76, 86, 145–157
I
Immediate causes. See Proximate causes
Immediate changes, design and implementation of, 72–73
168
Index
Public Information Policy of, 24, 28
reporting of sentinel events to, 17, 19, 21–28
Robust Process Improvement strategies of, vii, 4, 111
Sentinel Event Database of, viii, 22, 29, 54, 79, 83
sentinel event definition of, 1, 21, 23, 27, 28, 31, 32
Sentinel Event Policy of, vii, viii, 10, 11, 17, 18, 19–29,
32–33
Universal Protocol for Preventing Wrong Site, Wrong
Procedure, Wrong Person Surgery of, 87–88
website resources of, 11, 21, 22, 26, 28, 55
The Joint Commission Connect extranet site, vii, 21, 22,
26, 28
Joint Commission International (JCI)
acceptance of corrective action plan by, 10–11, 30,
33, 101
reporting of sentinel events to, 21, 29–30
sentinel event definition of, 1, 4, 29, 30, 31, 32
Sentinel Event Policy of, 4, 10, 17, 29–30, 32–33
standards of, 4, 7, 30–31
The Joint Commission Perspectives, 21, 54
M
Malpractice claims, 42, 161
Management factors, 69, 155
in corrective actions, 100
Measurement, 69–72
checklist on, 72, 105
choice of measures in, 70, 71, 72, 105
of corrective actions, 70, 95, 97, 102, 103, 104, 105
data in, 70, 159
definition of, 69, 161
in DMAIC model, 102, 103, 104, 111
indicators used in, 70, 71, 72, 105, 161
key questions on, 73, 105
outcome measures in, 70–71, 162
process measures in, 70–71, 162
purposes of, 69–70
Measure of success, 29, 157
Media
notification of event, 37
reports on patient safety events in, vi, 2, 21, 26, 30, 54
Medical mistakes and errors, 32, 42
Medication errors, vii, 2, 48
check sheet on, 118
close calls in, 18
common causes of, 7
corrective actions in, 2, 93, 95, 97, 105
definition of, 161
documentary evidence on, 63
evidence in, 37, 62
flowcharts on, 126
histogram on, 128
information collected on, 59
literature review on, 63
media reports on, vi, 2, 54
mistake proofing in prevention of, 93
operational definition of, 130
in ordering, 54
organizational hierarchy as factor in, 54
proximate causes of, 9
questions in investigation of, 11, 15, 66, 67
reporting of, 56
risk containment in, 37
risk points and risk reduction in, 88, 89–90
root causes of, 9, 11, 15
scatter diagram on, 137
team investigation of, 51, 56, 95, 105
variation as factor in, 8
L
Labeling of medications, 15
Laboratory testing
affinity diagram on, 114
value stream mapping on, 144
Latent conditions, 7, 8, 82, 161
Leadership
checklist on, 81
in corrective actions, 10, 100, 107
in high-reliability organizations, 2, 3–4
and organizational culture, 31, 33–35, 36, 69, 77, 155
quality improvement responsibilities of, 30–31
questions in analysis of, 78
reports provided to, 107
sentinel event policy on responsibilities of, 31
standards on, 19
survey process on, 42
of team, 49, 50, 52–53, 56
Lean Six Sigma, 103, 111, 113, 161
and Robust Process Improvement, 4, 111
Leape, Lucian L., 86, 87
Legal issues, 23–26, 33, 34, 37, 42
in confidentiality concerns, 24–26, 33, 59
in malpractice claims, 42, 161
Literature review, 62–63
169
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
Meetings of team members, 49, 51–52
Mistake proofing, 92–95
Motorola, 111, 113
Multivoting, 75, 85, 102, 112, 129, 161
reporting of, 21
response to, 19
as sentinel events, 1, 17–18, 19, 20, 26. See also
Sentinel events
Performance improvement, 36
in high reliability organizations, 3
high-risk processes identified in, 54
immediate changes for, 73
Joint Commission standards on, 7, 42
leadership in, 3, 36
root cause analysis in, 3, 4, 111
team approach to, 36, 49, 50
tools and techniques for. See Tools and techniques
Photographs for recording information, 58, 59
Physicians
change affecting, 101
communication errors of, 68
communication with patient and family, 42
in organizational hierarchy, 54
as team members, 50
Pilot test of corrective actions, 101
Policy, definition of, 162
Practice guidelines or parameters, 93, 162
Practitioner, definition of, 162
Precontemplation stage in change process, 101
Preferred practice patterns, 162
Preparation for root cause analysis, viii, 47–63
Prescribing, definition of, 162
Proactive risk reduction, 19, 86
failure mode and effects analysis in, vii, 4, 92, 121–122
leadership in, 35, 36
root cause analysis in, vi, 4, 19, 88, 92
value of, vi
Problem definition, 53–56, 66
in complex systems, 54
in DMAIC model, 102, 103, 104, 111
identification of high-risk processes in, 54
in multiple causal factors, 53–54
operational definition in, 85, 112, 130, 161
Problem investigation, 58–63
in DMAIC model, 102, 103, 104, 111
in early response, 37–42
evidence in, 37, 59, 62–63
fear of blame in, 58
identifying root causes in, 75–84
immediate changes made during, 72–73
improving staff comfort in, 58
N
National Academy for State Health Policy (NASHP), 25
National Center for Patient Safety (Veterans Affairs), 92, 93
National Patient Safety Foundation, vii, 2
National Patient Safety Goals, 29, 33
National Quality Forum, 25
Near-miss events. See Close calls
No-blame environment, 52, 53, 60, 83
No-harm events, vi, 18, 19, 161
Non-value-added activities, 164
O
Office of Quality and Patient Safety, 21
On-site visits, 27, 28, 42
Open-ended interview questions, 60, 61
Operational definitions, 85, 112, 130, 161
Ordering
changing system of, 101
as risk-prone system, 54
Organizational culture, 31, 33–35, 36, 69, 77, 155
hierarchies in, 54
safety in, 3, 31, 35–36
Organizationwide performance improvement, 162
Outcome measures, 70–71, 162
P
Pareto charts, 75, 85, 102, 112, 131–132, 162
Patients
affected by sentinel event, 36–37, 42, 43–45
communication errors with, 68
identification of, 15
use of term, ix, 162
Patient Safety and Quality Improvement Act (2005), 25
Patient safety events, v
as adverse events, 18, 19. See also Adverse events
as close calls, 18, 19. See also Close calls
definition of, 18, 32, 162
examples of, vi, 20
frequency/severity matrix on, 4, 5–6
investigation of, 1–2
multiple, 7
as no-harm events, vi, 18, 19, 161
170
Index
literature review in, 62–63
questions asked in, 66, 67
recording methods in, 58–59
scientific method in, 95
team approach to, 48–53
witness statements and observations in, 59–61
work plan in, 54–56
written statements in, 58, 61
Procedure
definition of, 162
failures related to, 68
Process
contributing factors in, 9, 66–67, 69
corrective actions in, 93
coupled systems in, 54
definition of, 93, 162
failure to follow, 68
flawed, 68, 93
flow in, 113
high-risk, 54
measures of, 70–71, 162
pull in, 113
risk points in, 88
risk reduction strategies in, 87
root cause analysis of, 11
stable and unstable, 8
variations in, 8, 87
Project REFRESH, 29
Protocols, 162
Proximate causes, viii, 9, 65–74
definition of, 162
identification of, 66–69
immediate changes made in, 72–73
measures on, 69–72
root causes compared to, 7, 79
staff interviews on, 60
underlying causes of, 76–79
Public Information Policy, 24, 28
Pull, in process, 113
R
Rape, 7, 20, 29, 32
Rate-based indicators, 71
Redundancy, in risk reduction strategies, 88
Referrals, 162
Relations diagrams, 75, 85, 112, 133–134, 163
Relevance, definition of, 163
Reliability, 163
Reporting of sentinel events, 33, 37–42, 56
benefits of, 21–22
confidentiality in, 24–26, 28, 29, 30, 33, 37
costs in, 27
developing policies on, 31–33
disclosable information in, 27–28, 33, 37, 42, 43–45
documentation for, 37, 38–41
by electronic submission, 28
incident reports in, 37, 38, 161
to The Joint Commission, 17, 19, 21–28
to Joint Commission International, 21, 29–30
legal issues in, 23–26
methods of, 22–23, 26, 27, 28, 29–30
in on-site interactions, 27, 28
policy evaluation checklist on, 34
state and federal requirements on, 25
in survey process, 42
time allowed for, 28
Research programs, 31
Resilience, vi, 163
Reviewable sentinel events
examples of, 21, 24
JCI policy on, 7, 29–30, 33
The Joint Commission policy on, 11, 18, 19, 28, 33
medication errors as, 11, 15
Risk containment, 37
Risk management, 37
Risk points, 9, 11, 88, 89–91, 163
Risk reduction strategies, 86–92
in commitment to excellence, 4
corrective actions in, viii, 4, 7, 10, 27, 28, 86–92
fail-safe design in, 88
failure mode and effects analysis in, 4, 121–122
follow-up activities in, 10
forcing functions in, 86
framework for, vii
in high-reliability organizations, 86, 88
in high-risk processes, 54
Q
Quality improvement, 4, 30–31, 162
Quality Improvement and Patient Safety (QPS) standards,
4, 30–31
Quality of care, 162
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
identification of, 88
immediate changes in, 72–73
levels of design in, 86–87
in multiple root causes, 9
proactive. See Proactive risk reduction
redundancy in, 88
Sentinel Event Database on, 29
systems approach in, 2, 86, 87–88
Risk signals, vi, 18
Robust Process Improvement (RPI), vii, 4, 111
Root cause
contributing cause compared to, 79, 82
definition of, 1–2, 163
evaluation checklist on, 82
identification of, v, viii, 75–84
multiple, 9, 53–54, 79–84
proximate cause compared to, 7, 79
pruning list of, 79
ranking criteria on, 4, 5–6, 53–54
rules on statement of, 10, 14
Sentinel Event Database on, 29, 79, 83
types of, 69
Root cause analysis, v–vii
acceptability of, 28, 30, 33
benefits of, 9
case studies on, 2
causal statement in, 10, 14
clarification of issues in, 76
confidentiality in, 33, 59, 83. See also
Confidentiality issues
corrective action plan produced in, 4, 10–16, 85–108.
See also Corrective action plan
criteria-based review of, 79
definition of, v, 1–2, 163
effective, strategies for, 11
evaluation checklist on, 12–13
and failure mode and effects analysis, 4, 92
fear of blame in, 58
follow-up activities in, 10, 12–13, 29
framework for, vii, 13, 28, 66, 76, 86, 145–157
in high reliability industries, 2–4
immediate changes made during, 72–73
improvement challenges in, 10
maximizing value of, 10
in multiple safety events, 7, 53–54
overview of, vii–viii, 1–16
performance improvement in, 3, 4, 111
preparation for, viii, 47–63
proactive, vi, 4, 19, 88, 92
problem definition in, 53–56. See also
Problem definition
problem investigation in, 58–63. See also
Problem investigation
proximate causes in, 7, 65–74. See also Proximate causes
questions asked in, 11, 15, 66, 67, 78, 147–152
recording methods in, 58–59
reluctance in, 83–84
retrospective, 4
sharing information from, 9, 17, 29, 54
steps in, 13, 16, 47, 57, 65, 75, 85
submission of, 28
in survey process, 46
systems approach to, 9, 11, 14
team approach to, 7, 48–53. See also Team approach
time allowed for, 27, 28, 30, 56
tools and techniques in, 112. See also Tools
and techniques
work plan in, 48–49, 54–56
Run charts, 85, 112, 135, 163
S
Safety, 86–87
culture of, 3, 31, 35–36
designing for, 87
Safety Assessment Code Matrix, 5–6
Sampling methodology, 157
Scatter diagrams, 85, 112, 136–137, 163
Scientific method, 95, 102, 163
Seclusion, 163
errors in, 16
Sentinel Event Alerts, 29, 35, 54, 55
Sentinel Event Database, viii, 22, 29, 54, 79, 83
Sentinel Event Measure of Success (SE MOS), 29, 33
Sentinel Event Policies
comparison of, 32–33
evaluation checklist on, 34
goals of, 21, 32
of The Joint Commission, vii, viii, 10, 11, 17, 19–29,
32–33
of Joint Commission International, 4, 10, 17, 29–30,
32–33
steps in development of, 31–33
in team approach, 51
Sentinel events, v, viii, 17–46
annual number reported, 23, 24
172
Index
appropriate patient care in, 36–37
communication and disclosure on, 33, 37–42, 54
compared to medical errors, 32
comprehensive systematic analysis of. See Comprehensive
systematic analysis
confidentiality issues in. See Confidentiality issues
criterion for, 8
definitions of, 1, 4, 17–18, 26, 27, 29, 31, 34, 163
documentation of. See Documentation
evidence in. See Evidence in sentinel events
examples of, 20, 48
follow-up activities on, 10, 12–13, 29, 33
framework for response to, 13
investigation of, vi, 1, 37–46. See also
Problem investigation
leadership and organizational culture in, 31, 33–35
legal issues in, 23–26, 33, 37, 42
preliminary assessment of, 27
preparation for root cause analysis in, 47–63
process flow in, 21, 22
proximate cause of. See Proximate causes
reporting of. See Reporting of sentinel events
response to, 7, 18, 19, 27, 28–29, 33, 35, 36–37
reviewable. See Reviewable sentinel events
risk containment in, 37
risk points in, 9, 11, 88, 89–91, 163
and safety culture, 35–36
standards related to, 4, 7
types of, 24
underlying cause of. See Underlying causes
variation as factor in, 1, 8–9. See also Variations
Services, ix, 163
Severe temporary harm, 1, 8, 18, 19
examples of, 20
Severity/frequency matrix on safety-related problems,
4, 5–6
Sexual abuse and assault, 7, 20, 29, 32
Single-event indicators, 71
SIPOC process map, 85, 112, 138, 163
Six Sigma, 111, 163
Lean, 103, 111, 113, 161
Special-cause variations, 8–9, 76, 164
Stable process, 8
Staff, vi, 163
failure to follow process, 68
interviews with, 59–61
medication errors of, 15
orientation and training on sentinel event policy, 33, 34
performance factors related to, 69, 155
in team approach, 49
Stakeholder analysis, 85, 112, 139–140, 163
Standard deviation, 111, 119, 164
Standards, 164
on leadership, 19
on quality improvement and patient safety, 4, 30–31
on sentinel events, 4, 7, 32
Standard work, 85, 112, 141–142, 164
State reporting requirements, 25
Storage of medications, 15
Storytelling as communication strategy, 108
Suicide, 20, 48, 164
corrective actions in, 93, 97, 105
documentary evidence on, 63
fishbone diagram on, 93, 124
immediate changes after, 72–73
information collected on, 59
literature review on, 62
physical evidence on, 62
problem statement on, 53
proximate causes in, 68
reporting mechanism in, 56
risk points and risk reduction strategies in, 54, 88,
90–91
root causes in, 77, 79, 83
Sentinel Event Database on, 83
team investigation of, 51, 56, 68, 77, 93, 105
Suppliers, inputs, process, outputs, customers (SIPOC)
process map, 85, 112, 138, 163
Surgical procedures
brainstorming on, 115
control charts on patterns in, 120
retained surgical item in, 20, 83
risk points in, 88
universal protocol on, 73, 74, 87–88
wrong-site, wrong-procedure, or wrong-patient.
See Wrong-site, wrong-procedure, or
wrong-patient surgery
Survey, 27, 42, 46, 164
Surveyors, 27, 42, 46, 164
Swiss cheese model on errors, 2, 3, 86
Systemic-cause (common-cause) variation, 8, 9, 76, 164
Systems approach
in high reliability industries, 2
in risk reduction strategies, 2, 86, 87–88
in root cause analysis, 9, 11, 14
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ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
T
stakeholder analysis, 85, 112, 139–140, 163
standard work, 85, 112, 141–142, 164
value stream mapping, 85, 112, 143–144, 164
Total quality management, 162
Toyota Production System, 111, 113
Training of staff on sentinel event policies, 33, 34
Treatment delay, 48
corrective actions in, 95, 105
information collected on, 59
literature review on, 62–63
multiple root causes in, 83
reporting mechanism in, 56
Sentinel Event Database on, 83
team investigation of, 51, 56, 95, 105
Team approach, 7, 48–53, 69
ad hoc members in, 50
advantages of, 49
communication in, 52–53, 56
composition of team in, 49–50, 51
confidentiality in, 53
core members in, 50, 51
in corrective actions, 85–108
essential elements in, 49
facilitator role in, 50, 52, 56
failure mode and effects analysis in, 92
icebreaker activities in, 53
identification of underlying causes in, 76–79
leaders in, 49, 50, 52–53, 56
meetings in, 49, 51–52
mission of, 51
no-blame environment in, 52, 53
in performance improvement, 36, 49, 50
in problem identification, 53–56
in problem investigation, 58–63
rules in, 50–52, 53
Telephone interviews, 61
To Err is Human: Building a Safety Health System, v
Tools and techniques, viii, 65, 111–144
affinity diagrams, 65, 68, 85, 112, 113–114, 159
brainstorming. See Brainstorming
change analysis, 65, 67, 75, 112, 116, 159
change management. See Change management
check sheets, 112, 118, 159
comparison of, 112
control charts, 102, 106, 112, 119–120, 160
DMAIC model, 102, 103, 104, 111–113, 160
fishbone diagrams. See Fishbone diagrams
flowcharts. See Flowcharts
FMEA. See Failure mode and effects analysis
Gantt charts. See Gantt charts
histograms. See Histograms
Lean Six Sigma, 4, 103, 111, 113, 161
multivoting, 75, 85, 102, 112, 129, 161
operational definitions, 85, 112, 130, 161
Pareto charts, 75, 85, 102, 112, 131–132, 162
relations diagrams, 75, 85, 112, 133–134, 163
Robust Process Improvement, vii, 4, 111
run charts, 85, 112, 135, 163
scatter diagrams, 85, 112, 136–137, 163
SIPOC process maps, 85, 112, 138, 163
U
Uncontrollable factors, viii, 9, 67, 77
questions in analysis of, 78
Underlying causes, 7, 8
definition of, 164
identification of, 67, 76–79
measures on, 69–72
Universal Protocol for Preventing Wrong Site, Wrong
Procedure, Wrong Person Surgery, 73, 74, 87–88
Unsafe or hazardous conditions, 18, 19, 161
Unstable process, 8
Utility systems, 9, 50, 63, 164
V
Value stream mapping, 85, 112, 143–144, 164
Variations, vi, 8, 159, 164
common-cause, 8, 9, 76, 164
in process, 8
root cause analysis of, 1
special-cause, 8–9, 76, 164
Veterans Affairs National Center for Patient Safety, 92, 93
Video recordings, 58, 59
W
Witness statements and observations, 59–61
Womack, James, 111
Work of organization, functions and processes in, 93
Work plan for sentinel event investigation, 48–49, 54–56
Wrong-site, wrong-procedure, or wrong-patient surgery,
7, 20
in error of commission, 19
evidence on, 62
JCI policy on, 29, 32
174
Index
multiple root causes in, 83
organizational hierarchy as factor in, 54
outcome measures on, 71
Pareto chart on, 132
problem statement on, 53
risk points and risk reduction strategies in, 88, 90
Sentinel Event Database on, 83
universal protocol for prevention of, 73, 74, 87–88
WWW (who, what, when) tool, 13
175
ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition
176