Root Cause Analysis in Health Care Tools and Techniques

SIXTH EDITION Includes Flash Drive! Senior Editor: Laura Hible Project Manager: Lisa King Associate Director, Publications: Helen M. Fry, MA Associate Director, Production: Johanna Harris Executive Director, Global Publishing: Catherine Chopp Hinckley, MA, PhD Joint Commission/JCR Reviewers for the sixth edition: Dawn Allbee; Anne Marie Benedicto; Kathy Brooks; Lisa Buczkowski; Gerard Castro; Patty Chappell; Adam Fonseca; Brian Patterson; Jessica Gacki-Smith

Joint Commission Resources Mission The mission of Joint Commission Resources (JCR) is to continuously improve the safety and quality of health care in the United States and in the international community through the provision of education, publications, consultation, and evaluation services. Joint Commission Resources educational programs and publications support, but are separate from, the accreditation activities of The Joint Commission. Attendees at Joint Commission Resources educational programs and purchasers of Joint Commission Resources publications receive no special consideration or treatment in, or confidential information about, the accreditation process. The inclusion of an organization name, product, or service in a Joint Commission Resources publication should not be construed as an endorsement of such organization, product, or service, nor is failure to include an organization name, product, or service to be construed as disapproval. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. Every attempt has been made to ensure accuracy at the time of publication; however, please note that laws, regulations, and standards are subject to change. Please also note that some of the examples in this publication are specific to the laws and regulations of the locality of the facility. The information and examples in this publication are provided with the understanding that the publisher is not engaged in providing medical, legal, or other professional advice. If any such assistance is desired, the services of a competent professional person should be sought. © 2017 The Joint Commission Joint Commission Resources, Inc. (JCR), a not-for-profit affiliate of The Joint Commission, has been designated by The Joint Commission to publish publications and multimedia products. JCR reproduces and distributes these materials under license from The Joint Commission. All rights reserved. No part of this publication may be reproduced in any form or by any means without written permission from the publisher. Printed in the USA 5 4 3 2 1 Requests for permission to make copies of any part of this work should be sent to [email protected] ISBN: 978-1-59940-984-9 (soft cover) ISBN: 978-1-59940-985-6 (E-book) ISSN: Pending Library of Congress Control Number: 2009931192 For more information about Joint Commission Resources, please visit http://www.jcrinc.com. 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 RCA2 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

iii 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. Today, quality-of-care issues are a problem for health They can affect anyone directly or indirectly involved in care organizations around the world. The World Health the event. To address and prevent such events, health care Organization (WHO) estimates that of 421 million organizations must unearth the root cause(s) underlying hospitalizations globally each year more than 42 million these events and develop solutions that prevent, anticipate, patients will suffer an adverse event.3 And the problem is and avoid the problems from a systems perspective. certainly not limited to developing nations with small or underfunded health care systems. The WHO also estimates Despite remarkable advances in almost every contempo- that on average in the United Kingdom there is an incident rary field of health care, system vulnerabilities and process of patient harm every 35 seconds, and that up to 15% flaws result in harm to patients. In fact, Sutcliffe, Paine, of hospital expenditures in Europe go to treating and Pronovost assert that “the hallmark of an HRO [high safety accidents.4 reliability organization] is not that it is error free but that errors do not disable it. In a health care context, an HRO Although such reports and chart reviews illuminate the would not be error free, it would be harm free.”1 problem, it is impossible to know how many patients suffer as a result of health care system failures. Even a single System and process weaknesses are not often immediately patient safety event is cause for concern. Such events can apparent and require investigation. This is particularly true result in tragedy for patients and their families, add costs to for sentinel events, patient safety events not primarily related an already overburdened health care system, adversely affect to the natural course of the patient’s illness or underlying the public’s perception of an organization, and lead to condition that reach a patient and result in death, perma- litigation. They can also deeply impact dedicated health nent harm, or severe temporary harm. care professionals concerned for their patients.

The prevalence of patient safety events was thrust into Health care organizations can address flawed systems only the limelight with the watershed report To Err Is Human: when they consider this question: Why do these failures Building a Safer Health System, published in 2000 by the continue to occur? Institute of Medicine (IOM), now the National Academies of Sciences, Engineering, and Medicine. The IOM report To answer this question, an organization will need to was just the beginning. More reports followed, empha- perform a comprehensive systematic analysis. The most sizing the need to improve health care quality in the commonly used form of comprehensive systematic analysis United States. For example, researchers at Johns Hopkins among Joint Commission–accredited organizations is root Children’s Center and the US Agency for Healthcare cause analysis (RCA)—a process identifying the basic or Research and Quality reviewed 5.7 million records of causal contributing factor(s) underlying variation in patients under 19 years old from 27 states who were hospi- performance, including the occurrence or possible occur- talized in 2000. The researchers identified 52,000 as being rence of a sentinel event. Organizations can use root cause harmed by unsafe medical care during their hospital stays, analysis to deliver safer care, uncovering the factors that with 4,483 suffering a fatal injury.2 lead to patient safety events.

v ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Although health care organizations in the United States Pharmacists to institute a mandatory incident reporting often use root cause analysis to help improve quality and program for all pharmacies in Ontario.7 attain accreditation, such analysis has many broader appli- • In February 2017 the state of Minnesota reported that cations around the world. Whether delivered in New York 106 patients in that state were seriously injured and City or Dubai or Singapore, organizations can use root another 4 patients died as a result of patient safety events cause analysis to improve processes and provide high- during 2016.8 quality care. • In June 2017 a Pennsylvania jury awarded $870,000 to a man after a surgeon removed the wrong testicle in a The Current Health Care Environment 2013 procedure.9 Health care continues to experience dramatic change. Health care organizations evolve constantly due to The above examples are only a few of the serious patient changes in reimbursement, new technology, regulatory safety events that have attracted media attention in recent requirements, and staffing levels. These modifications years. These events cast a shadow on the public’s trust of cause policies and procedures to change often. As health health care. Stakeholders, including patients, justifiably care organizations become more complex, their systems ask, “What’s going on?” Failure detection, reduction, and and processes are increasingly interdependent. This interde- prevention strategies are receiving new impetus as the pendence increases the risk of failures and makes the health care community recognizes the value of a proactive recovery from failure difficult. Clinical and support staff approach to reducing risk. workloads grow heavier, resulting in greater stress, fatigue, and burnout for many health care professionals. Root cause analysis is one such approach. Historically used Caregivers work in new settings and perform new func- to investigate sentinel events, root cause analysis shows great tions, sometimes with only minimal training. Maintaining promise as a proactive tool. Increasingly, health care organi- consistency in processes and systems becomes challenging zations are using this methodology to investigate close calls, and leads to variation. Often, this variation results in no-harm patient safety events, and other signals of risk. increased risk to patients. 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: When an adverse outcome, a sentinel event, or a cluster • In September 2013 researchers estimated that the of less serious incidents or close calls occurs, organiza- number of premature deaths associated with preventable tions must develop an understanding of the contributing harm to patients in US hospitals was more than 400,000 factors and protective factors (those factors that allowed a per year. This makes patient safety events the third problem to be identified and corrected or “things that went leading cause of death in the United States. Incidents right”) and the interrelationship of those factors. Next, resulting in serious patient harm were estimated to be the organization must implement a corrective action plan 10–20 times more common than lethal harm.5 that augments and supports protective factors to reduce • In May 2016 a New York outpatient surgical clinic system vulnerabilities focusing on how to enable successful settled for an undisclosed amount and accepted processes more often. An approach that focuses on enabling responsibility in the death of comedian Joan Rivers, successful processes will help improve the system’s resilience, who stopped breathing during a laryngoscopy procedure the degree to which it continuously prevents, detects, miti- in 2014.6 gates, or ameliorates hazards or incidents.10 • In October 2016 the parents of an 8-year-old Canadian boy filed a $4 million lawsuit against an Ontario Purpose of This Book pharmacy for its role in a medication error that resulted Root Cause Analysis in Health Care: Tools and Techniques, in their son receiving a lethal dose of the muscle relaxant Sixth Edition, is intended to help health care organizations baclofen. The incident and an ensuing petition drive led prevent systems failures by using root cause analysis to do by the boy’s mother prompted the Ontario College of the following:

vi Introduction

• Identify causes and contributing factors of a sentinel analysis to minimize the possibility of patient safety events event or a cluster of incidents. and thereby to improve the care, treatment, and services • Identify system vulnerabilities that could lead to provided at their facilities. patient harm. • Implement strong and corrective risk-reduction strategies What’s New in This Edition that decrease the likelihood of a recurrence of the event This sixth edition provides updated statistics and intro- or incidents. duces new concepts and tools associated with RCA2: • Determine if corrective actions are successful Improving Root Cause Analyses and Actions to Prevent Harm, and sustained. the National Patient Safety Foundation’s in-depth report focusing on the techniques and processes of how root cause Root cause analysis is an effective technique most analyses can best prioritize system flaws and vulnerabilities commonly used after an error has occurred to identify and make improvements to successfully improve patient underlying causes. Failure mode and effects analysis (FMEA) care in all health care settings. This goal is accomplished is a proactive technique used to prevent process and through the implementation and measurement of reme- product problems before they occur.11 Health care organiza- dial actions and processes. This book also includes new and tions should learn both techniques to reduce the likelihood revised tools aligned with The Joint Commission’s Robust of adverse events. Process Improvement® (RPI®), a set of process improvement strategies adopted by The Joint Commission to help organi- Root Cause Analysis in Health Care: Tools and Techniques, zations improve business processes and clinical outcomes. Sixth Edition, provides health care organizations world- wide with information on The Joint Commission’s Sentinel Overview of Contents Event Policy and safety-related requirements. (For the most Root Cause Analysis in Health Care: Tools and Techniques, up-to-date information on the policy and requirements, Sixth Edition, provides health care organizations with see the “Quality and Patient Safety” section on your Joint practical, how-to information on conducting a root cause Commission ConnectTM extranet site.) It also describes the analysis and effective corrective action plan. Twenty-one Sentinel Event Policy and related requirements of Joint steps are described in Chapters 3 through 6. Teams Commission International. The book includes examples conducting a root cause analysis might not follow these that guide the reader through application of root cause steps in a sequential order. Often, numerous steps will analysis to the investigation of specific types of sentinel occur simultaneously, or the team will return to earlier events, such as medication errors, suicide, treatment delay, steps before proceeding to the next step. It is crucial for and elopement. 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 Appropriate tools for use in each stage of root cause analysis analysis. It also helps organizations do the following: appear in each chapter in the form of checklists, matrices, • Identify the processes that could benefit from root cause and more. In the e-book version, internal links allow you to analysis. easily search for terms and navigate across chapters. Links • Conduct a thorough and credible root cause analysis. even take you directly to the downloadable, customizable • Interpret analysis results. tools (in the print version, these tools are delivered on a • Develop and implement a strong corrective action plan flash drive). for improvement. • Assess the effectiveness of risk-reduction efforts. A chapter-by-chapter description of the contents follows. • Integrate root cause analysis with other programs. Chapter 1, “Root Cause Analysis: An Overview,” takes a Even without the occurrence of an adverse event, health holistic look at root cause analysis. It describes variation care organizations should embrace the use of root cause and developing causal statements, how proximate and root

vii ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

causes differ, when root cause analysis can be conducted, In addition, the chapter describes the process of designing and the benefits of root cause analysis. One of the benefits and implementing interim changes. involves effectively meeting Joint Commission and Joint Commission International requirements that relate to the Chapter 5, “Identifying Root Causes,” provides practical management of sentinel events. The chapter also provides ­guidance on identifying or uncovering the root causes— guidelines on the characteristics of a thorough and credible the systems that underlie sentinel events—and the inter­ root cause analysis and corrective action plan and empha- relationship of the root causes to one another and to other sizes the role of leadership and its impact on high reliability. health care processes. The chapter explores and describes systems, including human resources, information manage- Chapter 2, “Addressing Sentinel Events in Policy and Strategy,” ment, environment of care, leadership, communication, describes the types of adverse events occurring in health and uncontrollable factors. The chapter also addresses how care. It lists in full The Joint Commission’s Sentinel Event to differentiate root causes and contributing factors. Policy and requirements, including The Joint Commission’s sentinel event definition. The chapter also discusses Joint Chapter 6, “Designing and Implementing a Corrective Action Commission International’s Sentinel Event Policy and Plan for Improvement,” includes practical guidelines on how related requirements. The chapter provides practical to design and implement a corrective action plan—the guidelines on how an organization can develop its own improvement portion of a root cause analysis. During this sentinel event policy, including the role that an organi- stage, an organization identifies risk-reduction strategies, zation’s culture and leadership play in risk reduction and designs and implements improvement strategies to address prevention, which is part of a patient safety system. It also underlying systems problems, and makes a determination describes the need for root cause analysis and provides prac- of the strength of the action. The chapter includes charac- tical guidance on the early steps involved in responding to teristics of an acceptable corrective action plan, as well as an adverse or sentinel event. information on how to assess the effectiveness of improve- ment efforts. The chapter concludes with information on Chapter 3, “Preparing for Root Cause Analysis,” covers the how to effectively communicate the results in improvement early steps involved in performing a root cause analysis. The initiatives. first of four hands-on step-by-step chapters, it describes how to organize a root cause analysis team, define the Chapter 7, “Tools and Techniques,” presents the tools and problem, and gather the information and measurement data techniques used during root cause analysis. Each tool to study the problem. The chapter provides details about profile addresses the purpose of the tool, the appropriate team composition and ground rules. It also covers how stage(s) of root cause analysis for the tool’s use, simple steps to use information from The Joint Commission’s Sentinel for success, and tips for effective use. The chapter profiles Event Database and accreditation requirements to iden- 21 tools: affinity diagrams, brainstorming, change analysis, tify problem areas needing root cause analysis. The chapter change management, check sheets, control charts, failure provides guidance on recording information obtained mode and effects analysis, fishbone diagrams, flowcharts, during a root cause analysis, conducting interviews, and Gantt charts, histograms, multivoting, operational defini- gathering physical and documentary evidence. tion, pareto chart, relations diagram, run charts, scatter diagrams, SIPOC process maps, stakeholder analysis, Chapter 4, “Determining Proximate Causes,” provides prac- standard work, and value stream mapping. A discussion of tical guidance on the next stage of root cause analysis— a performance improvement methodology, Lean Six Sigma, determining what happened and the reasons it happened. and change management incorporates many of these tools The chapter describes how to further define the event, and precedes the tool descriptions. References to these identify process problems, determine which care processes many tools appear in Chapters 3 through 6 in the “Tools are involved with the problem, and pinpoint the human, to Use” box appearing in each of these chapters. process, equipment, environmental, and other factors closest to the problem. The chapter also addresses how to The Joint Commission’s Framework for a Root Cause collect and assess data on proximate and underlying causes. Analysis and Corrective Action Plan appears as the

viii Introduction

Appendix. This framework and its 24 assessment questions, References referenced throughout Chapters 3 through 6, provides 1. Sutcliffe KM, Paine L, Pronovost PJ. BMJ Qual Saf Published a solid foundation for root cause analyses and corrective Online First: 21 Mar 2016 doi:10.1136bmjqs-2015-004698. action plans. A downloadable, editable version appears on 2. Miller MR, Zhan C. Pediatric patient safety in the flash drive. hospitals: A national picture in 2000. Pediatrics. 2004 Jun;113(6):1741–1746. Finally, the Glossary provides definitions of key terms used 3. Jha AK, Larizgoitia I, Audera-Lopez C, et al. The global burden of unsafe medical care: Analytic modelling of observational throughout the book. studies. BMJ Qual Saf. 2013;22:809–815. 4. Patient Safety: Making health care safer. Geneva: World Health A Word About Terminology Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO. patient individual served care recipient The terms , , and all 5. James JT. A new evidence-based estimate of patient describe the individual, client, consumer, or resident who harms associated with hospital care. J Patient Saf. 2013 actually receives care, treatment, and/or services. The term Sep;9(3):122–128. care includes care, treatment, services, rehabilitation, habil- 6. The New York Times. Settlement Reached in Joan Rivers itation, or other programs instituted by an organization for Malpractice Case. Santora, M. May 12, 2016. Accessed Jun 21, individuals served. 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 Joint Commission Resources is grateful to the many errors after boy’s death. Hudes, S. Jun 20, 2017. Accessed Jun 21, content experts who have contributed to this publication, 2017. https://www.thespec.com/news-story/7381446-ontario -pharmacists-to-be-required-to-report-errors-after-boy-s-death. including the following individuals: 8. Minnesota Department of Health (MDH). Adverse Health Events in Minnesota: 13th Annual Public Report. St. Paul: MDH: 2015. Dawn Allbee; Anne Marie Benedicto; Kathy Brooks; Accessed Jun 21, 2017. http://www.health.state.mn.us Lisa Buczkowski, RN, MS; Gerard Castro, PhD, MPH; /patientsafety/ae/2015ahereport.pdf. Patty Chappell; Adam Fonseca, MHA, RPI, BB; Jessica 9. International Business Times. Doctor Removes Wrong Testicle Gacki-Smith, MPH; Brian D. Patterson, LSS, MBB; From Pennsylvania Man, Jury Awards $870,000 In Damages. Jennifer Guowen Zhu. Ghosh, S. Jun 19, 2017. Accessed Jun 21, 2017. http://www .ibtimes.com/doctor-removes-wrong-testicle-pennsylvania In addition, JCR would like to thank writer James Foster -man-jury-awards-870000-damages-2554137. 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.

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x CHAPTER 1

Root Cause Analysis: An Overview

Learning Objectives What Is Root Cause Analysis? Root cause analysis is a process for identifying the basic • Understand the need for comprehensive systematic analysis of sentinel events and other or causal factor(s) underlying variation in performance. adverse outcomes Variation in performance can (and often does) produce unexpected and undesired adverse outcomes, including the • Learn how leadership and organizational occurrence or risk of a sentinel event. The Joint Commission commitment to constant improvement lead to a high reliability organization definessentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or • Understand the most effective timing for under­lying condition) that reaches a patient and results in performing a root cause analysis plan death, permanent harm, or severe temporary harm.* • Learn the importance of improving systems to prevent sentinel events or problems Similarly, Joint Commission International (JCI) defines • Learn the basics of root cause analysis (RCA), sentinel event as an unanticipated occurrence involving the most common method of comprehensive death or serious physical or psychological injury—serious systematic analysis physical injury specifically includes loss of limb or func- • Know how RCA and corrective action plans relate tion. A root cause analysis focuses primarily on systems and to The Joint Commission’s Sentinel Event Policy 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 Investigating Patient Safety Events: The Need understand a process or processes within the context of a for Comprehensive Systematic Analysis system, the causes or potential causes of variation that can The Joint Commission’s Sentinel Event Policy requires lead to error, and identify process changes that would make accredited health care organizations to conduct a compre- variation less likely to recur. hensive systematic analysis in the wake of a sentinel event. Comprehensive systematic analysis seeks to go beyond A root cause is the most fundamental reason (or one of individual performance issues to determine how gaps in several fundamental reasons) a failure, or a situation in policies and safety systems may have contributed to an which performance does not meet expectations, occurs. adverse event and to identify strong corrective actions to In common usage, the word cause suggests responsibility policies and procedures that may prevent similar events from occurring in the future. The Joint Commission * Severe temporary harm is critical, potentially life-threatening harm lasting reviews methods of comprehensive systematic analysis on for a limited time with no permanent residual, but requires transfer to a a case-by-case basis to determine their credibility, thorough- 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 ness, and acceptability. The Joint Commission also provides surgery, procedure, or treatment to resolve the condition. Adapted from advice and resources to institutions to assist them in Healthcare Performance Improvement, LLC. The HPI SEC & SSER assessing analytical tools. However, root cause analysis Patient Safety Measurement System for Healthcare, rev. 2. Throop C, Stockmeier C. May 2011. Accessed May 12, 2017. http://www.pressganey (RCA) is by far the most common method and is the .com/docs/default-source/default-document-library/hpi-white-paper---sec method preferred by The Joint Commission. -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 Sidebar 1-1 . RCA, however, the use of the word cause does not imply an Root Cause Analysis Case Example assignment of blame. Instead, the cause refers to a relation- ship or potential relationship between certain factors that A 16-year-old patient came to the hospital to deliver enable a sentinel event to occur. The focus in an RCA is her baby. During the process of her care, an infu- on a positive, preventive approach to system and process sion intended exclusively for the epidural route was changes following a sentinel event, a close call, or a cluster connected to the patient’s peripheral intravenous line of less serious yet potentially harmful incidents. and infused by pump. The patient experienced cardio- vascular collapse. A cesarean section resulted in the delivery of a healthy infant, but the medical team was As shown in Sidebar 1-1, root cause analyses can do more unable to resuscitate the mother. than discover that “A caused B.” The process also can help an organization determine that “if we change A because The media attention surrounding the error accelerated through the national provider and safety community we had a problem with it, we can reduce the possibility when the nurse was charged with a criminal offense. of B recurring or in fact prevent B from occurring in the These events set in motion intense internal and first place.” external scrutiny of the hospital’s medication and safety procedures. RCA is a powerful and useful tool that can help health The organization conducted a root cause analysis to care organizations around the world reduce errors and further understanding about latent systems gaps and move quality efforts forward. However, health care organiza- process failure modes. A team conducted a one-week tion leaders must realize that RCA is not a panacea but evaluation of the medication use system and the orga- one tool that should be used in conjunction with others nization’s current environment, systems and processes, to improve care. staffing patterns, leadership, and culture to help shape the recommended improvements. Team members iden- RCA2 in High Reliability Industries tified performance-shaping factors for each of the four proximate causes of the event. As mentioned in the Introduction, the National Patient Safety Foundation released in 2015 RCA2: Improving Root Although the hospital’s organizational learning was Cause Analyses and Actions to Prevent Harm, an in-depth painful, this event offered an opportunity for increasing report focusing on the techniques and processes of how root organizational competency and capacity for designing and implementing patient safety. The organization cause analyses can best prioritize system flaws and vulnera- implemented structures and processes, including safety bilities and make improvements to successfully improve nets and fail-safe mechanisms, to promote safer behav- patient care in all health care settings. Industries that are ioral choices for providers. regarded as highly reliable, such as nuclear power or the The hospital took a number of clinical steps to improve aerospace industry, employ RCA2 methodology to investi- the safety of medication administration, including gate adverse events. In the nuclear power and aerospace removing the barriers to scanning medication bar industries, sentinel events are rare because they have been codes, implementing consistent scanning-compliance anticipated. These high reliability industries have adopted a tracking, and providing teamwork training for all nursing systems approach, in which errors are viewed as an expected and physician staff practicing in the birth suites. part of the workplace, the result of a chance misalignment Source: Smetzer J, et al. Shaping systems for better behavioral of weaknesses in the underlying system.1 (Imagine a stack of choices: Lessons learned from a fatal medication error. Jt Comm J Qual slices of Swiss cheese. Each slice has holes in different Patient Saf. 2010 Apr;36(4):152–163. 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 High Reliability Characteristics Figure 1-1, page 3, represents how an error could possibly One of the distinguishing characteristics of high reliability penetrate multiple layers of barriers, defenses, and safe- industries and organizations is an organizational commit- guards in a system.) ment 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, potential dangers, risk factors, and problematic behavior. reporting, and improvement at all levels of the organiza- In this way, safety becomes a modus operandi. Constant tion. Leaders lead by example through their commitment improvement becomes a cultural norm within the orga- to fairness, accountability, and transparency. By giving indi- nization. The ongoing search for ways to improve reli- vidual workers and team members the confidence that the ability becomes integrated in the organization’s daily work, reporting of errors and relating of their concerns will not becoming simply “how we work.” be used against them, that reporting problems will result in improvements and corrective action, and that they will be Leadership dealt with honestly, leaders can encourage workers to buy in Again, the role of leadership in this process cannot be to changes and create a virtuous cycle. In addition, leaders overstated. Leadership sets the goal of zero error or zero in high reliability organizations also ensure that there is harm and promotes a collective mindfulness of safety and organizational support for performance improvement reliability. However, the commitment to zero harm must learning so that its workforce is able to find solutions to the include an honest, transparent accounting of the orga- improvement opportunities they find, furthering the cycle nization’s current level of reliability. In addition, leaders of improvement and transformation. must emphasize the value of reporting errors, close calls, and unsafe conditions because the information and data Performance Improvement collected in the investigation of errors is invaluable to an RCA2 methods are also an integral part of the process of organization that seeks to identify, learn from, and correct becoming a high reliability organization. Shifting the focus its mistakes. A high reliability organization acknowledges of investigation from “Who is responsible?” to “What needs what it does not know and seeks to know as much as it can, to change?” encourages workers trained in performance particularly about situations or incidents in which it falls improvement techniques to be on constant lookout for short of optimal performance. Compiling and analyzing

3 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

information and data across many adverse events, close analysis.2 The goal of the root cause analysis is to produce calls, and unsafe conditions enables a proactive assessment a corrective action plan identifying the strategies the orga- of safety policies and procedures. The goal is to become nization intends to implement to improve the likelihood proactive, to identify potential risks as far upstream as of favorable outcomes and reduce the risk of similar events possible and work to mitigate or eliminate them, rather occurring in the future. than to react to each event after the fact. Root cause analysis is also used increasingly by organi- Techniques and Strategies zations as one step of a proactive risk-reduction effort The Joint Commission’s Robust Process Improvement® using failure mode and effects analysis (FMEA). FMEA is (RPI®) system embraces these values. Through RPI, leaders a proactive, prospective approach used to prevent process and workers are trained in Lean Six Sigma analysis and and product problems before they occur. It provides a improvement techniques and Change Management® strat- look not only at what problems could occur—the failure egies. Use of these techniques and strategies empowers modes—but also at how severe the effects of those problems workers to identify problems in their daily work. The could be. The goal is to improve the likelihood of favorable tools enable them to analyze those problems and conceive outcomes and prevent harm to patients (see chapters 6 and possible improvements. These improvements are tailored to 7 for more information). One step of FMEA involves iden- the culture and environment of the organization. Finally, tifying the root causes of the failure modes.3 At this point in the tools equip individuals with skills and knowledge to the process, the FMEA team can use the RCA approach. implement improvements and maintain progress. Sidebar 1-2, pages 5–6, presents a frequency/severity matrix Commitment to Excellence organization for prioritizing safety-related problems. The An honest and transparent organization builds credibility matrix identifies four categories of severity that apply to both internally and with customers and the public. An both actual patient safety events and to close calls. Use of organization committed to zero harm, that seeks to identify the matrix can help the organization decide how to use its risks and failures at all levels so that it can learn from them, resources to determine which risks to analyze and mitigate that doesn’t settle for simple answers to complex questions, first. This determination can help organizations decide that understands the increased risk that comes with changes which adverse events, close calls, or hazards require a root in operations, that is committed to learning from its cause analysis. In this matrix, if a patient safety event gets a mistakes in an open and honest way, and that values high score in the severity category and a high probability of expertise at every level and invests in the development occurring again, then a root cause analysis is necessary.4 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 When Can a Root Cause Analysis organizations in the United States, and Joint Commission Be Performed? International (JCI), which accredits health care organi- Historically, organizations have most commonly used root zations in countries other than the United States, have cause analysis retrospectively—to probe the reasons for a bad a Sentinel Event Policy and standards related to sentinel outcome or for failures that have already occurred. Root events. For example, JCI Quality Improvement and Patient cause analysis can also be used by organizations to probe Safety (QPS) standards require each accredited organization a close call event or pattern of events or as part of other to establish an operational definition of a sentinel event and performance improvement redesign initiatives, such as a process for the in-depth analysis of such events. gaining an understanding of variations observed in system- atically collected data. The best RCAs address the entire When developing the definition of sentinel event, process and all support systems involved in a specific event JCI-accredited organizations must include at least those to minimize overall risk associated with that process, as well events that are described in the sentinel event standard as the recurrence of the event that prompted the root cause 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 b. If the event is a close call, assign severity based on injury, length of stay, level of care required for remedy, a reasonable “worst case” systems-level scenario. and actual or estimated physical plant costs. These four NOTE: For example, if you entered a patient’s room categories apply to actual adverse events and potential before they were able to complete a lethal suicide events (close calls). For actual adverse events, assign attempt, the event is catastrophic, because the severity based on the patient’s actual condition. reasonable “worst case” is suicide.

Catastrophic Major

Death or major permanent loss of function (sensory, motor, Patients with Actual or Potential: physiologic, or intellectual) not related to the natural course of the Permanent lessening of bodily functioning (sensory, motor, physiologic, or patient’s illness or underlying condition (that is, acts of commission intellectual) not related to the natural course of the patient’s illness or or omission). This includes outcomes that are a direct result of injuries underlying conditions (that is, acts of commission or omission) or any sustained in a fall; associated with an unauthorized departure from an of the following: around-the-clock treatment setting; or the result of an assault or other a. Disfigurement crime. Any of the adverse events defined by the Joint Commission as b. Surgical intervention required reviewable “Sentinel Events” should also be considered in this category. 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 experi- encing 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 Patients with Actual or Potential: No injury nor increased length of stay level of care for one or two patients nor increased level of care

Visitors: Evaluation and treatment for one or two visitors (less than Visitors: Evaluated and no treatment required or refused treatment hospitalization)

Staff: Medical expenses, lost time, or restricted duty injuries or illness for Staff: First aid treatment only with no lost time nor restricted duty injuries one or two staff nor illnesses

Equipment or facility: Damage more than $10,000 but less than Equipment or facility: Damage less than $10,000 or loss of any utility $100,000†‡ without adverse patient outcome (for example, power, natural gas, elec- tricity, 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 at your facility. Sometimes the data is easily available apply to actual adverse events and close calls. because the events are routinely tracked (for example, b. In order to assign a probability rating for an adverse falls with injury, ADEs, and so forth). Sometimes, getting event or close call, it is ideal to know how often it a feel for the probability of events that are not routinely occurs at your facility. Sometimes the data will be easily tracked will mean asking for a quick or informal opinion available because they are routinely tracked (for from staff most familiar with those events. Sometimes it example, falls with injury, adverse drug events (ADEs), will have to be the best educated guess. and so forth). Sometimes, getting a feel for the proba- (1) Frequent – Likely to occur immediately or within a bility of events that are not routinely tracked will mean short period (may happen several times in 1 year). asking for a quick or informal opinion from staff most (2) Occasional – Probably will occur (may happen familiar with those events. Sometimes it will have to be several times in 1 to 2 years). your best educated guess. Like the severity categories, (3) Uncommon – Possible to occur (may happen some- the probability categories apply to actual adverse events time in 2 to 5 years). and close calls. (4) Remote – Unlikely to occur (may happen sometime c. In order to assign a probability rating for an adverse in 5 to 30 years). event or close call, it is ideal to know how often it occurs

3 . How the Safety Assessment Codes (SAC) Matrix Looks

Probability and Catastrophic Major Moderate Minor Severity 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 1 = lowest risk) results. These ranks, or SACs, can then be When a severity category is paired with a probability used for doing comparative analysis and for deciding who category for either an actual event or close call, a ranked needs to be notified about the event. matrix score (3 = highest risk, 2 = intermediate risk,

5 . Reporting a. All known reporters of events, regardless of SAC score adverse events or close calls related solely to staff, (one, two, or three), must receive appropriate and visitors, or equipment and/or facility damage to relevant timely feedback. facility experts or services on a timely basis, for assess- b. The Patient Safety Manager, or designee, must refer ment 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 | Root Cause Analysis: An Overview

unanticipated death unrelated to review under JCI stan- Sidebar 1-3 . dards, such as unanticipated death related to the natural Investigating Multiple Patient course of the patient’s illness or underlying condition; Safety Events major permanent loss of function unrelated to the natural course of the patient’s illness or underlying condition; Although root cause analysis (RCA) is associated wrong-site, wrong-procedure, wrong-patient surgery; trans- frequently with the investigation of a single sentinel mission of a chronic or fatal disease or illness as a result of event, the methodology also can be used to determine infusing blood or blood products or transplanting contam- the cause of multiple occurrences of low-harm events. inated organs or tissues; infant abduction; rape, workplace For example, 40 Danish community pharmacies worked together, using RCA, to gain insight into medication violence leading to death or permanent loss of function, or errors, a problem that can result in serious conse- homicide on the organization’s property. quences for patients.

For organizations based in the United States, Joint The root cause analysis included investigation of 401 errors, many of which had potential clinical significance, Commission standards require the organization to have an even though each error did not necessarily result in organizationwide, integrated patient safety program within harm. Analyzed as a cluster, however, the RCA resulted its performance improvement activities (see the “Patient in the identification of four common medication Safety Systems” chapter in your program’s Comprehensive error causes1: Accreditation Manual). 1. Illegible handwritten prescriptions 2. Similar packaging or names, or misleading presenta- Particularly, organizations are required to conduct thor- tion of strength and dosage ough and credible comprehensive systematic analyses (for 3. Ineffective control of prescription label and medicine example, root cause analyses) in response to sentinel events. 4. Lapsed concentration caused by interruptions. RCA is the most commonly used form of comprehensive Reference: systematic analysis used by Joint Commission–accredited 1. Knudsen P, et al. Preventing medication errors in community organizations to comply with this requirement. 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 To meet these challenges, organizations must under- associated with services that the organization provides or stand not only the proximate causes, or active failures (the provides for. Appropriate response includes conducting a apparent, seemingly obvious reasons an error occurred) but timely, thorough, and credible comprehensive systematic also the underlying causes, or latent conditions (the aspects of analysis; developing a strong corrective action plan designed a process that can allow an error to occur), and the inter- to implement improvements to reduce risk; implementing relationship of the two. As shown in Figure 1-2, page 8, the improvements; and monitoring the effectiveness and active failures are only the “tip of the iceberg”—that which sustainability of those improvements. (See Sidebar 1-3 for is visible or proximal to the patient—while latent condi- a discussion of multiple events.) tions lurk unseen “underwater,” posing a hidden poten- tial danger. Root cause analysis helps organizations delve Variation and the Difference Between beneath the proximate causes to find the underlying causes Proximate and Root Causes of a sentinel event. Whether addressing a sentinel event or a cluster of less serious low-harm or close call events, root cause analysis in Conducting an RCA has significant resource implications. all environments provides two challenges: A team approach, involving a full range of disciplines and 1. To understand why the event occurred departments in the process being studied, is mandatory, as 2. To prevent the same or a similar event from occurring in will be described in Chapter 3. Organizations therefore will the future through prospective process design or redesign want to conduct root cause analysis principally to explore those events or possible events with a significant negative

7 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Understand Common-Cause Variation Figure 1-2 . The Relationships Between a Common-cause variation, although inherent in every Sentinel Event and Its Causes 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 active failures 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.

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 latent conditions 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. Active failures, shown as the “tip of the iceberg,” reveal only the proximate causes of a sentinel Special Cause Variation event; latent conditions loom below the waterline, Special-cause variation arises from unusual circumstances or representing the underlying causes. events that may be difficult to anticipate and may result in marked variation and an unstable, intermittent, and unpre- or potentially negative impact on the patient. The criterion dictable process. Special-cause variation is not inherently for a sentinel event is generally death, permanent harm, or present in systems. It is exogenous (that is, produced from severe temporary harm to the patient. the outside), resulting from factors that are not part of the system as designed. Mechanical malfunctions, fatigued Process Variations employees, and natural disasters such as floods, hurri- Adverse or sentinel events involve a variation in a process. canes, and earthquakes are examples of special causes that When this variation occurs, the probability of a serious result in variation. Organizations should strive to identify, adverse outcome increases. As mentioned previously, RCA mitigate, and/or eliminate special causes wherever possible. is a process for identifying the basic or causal factor(s) However, removing a special cause eliminates only that underlying variation in performance. Variation is a change current abnormal performance in the process. It does not in form, position, state, or qualities. Although a sentinel prevent the same special cause from recurring. For example, event is the result of a variation in a process, variation is firing an overly fatigued employee who was involved in a inherent in every process. To reduce variation, it is neces- medication error does little to prevent the recurrence of the sary to determine its cause. What’s more, variation can be same error. Instead, organizations should investigate, under- classified by its cause. stand, and address underlying common causes within their systems and processes such as shift length, work schedules,

8 CHAPTER 1 | Root Cause Analysis: An Overview

task design, employee education, complacency, information medication procurement process, communication prob- management, and communication. lems, 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 Most root causes alone are not sufficient to cause a failure; a part. For example, mechanical breakdown of a piece of rather, the combination of root cause(s) and other contrib- equipment used during surgery may indicate a problem uting factors sets the stage. For example, flaws in the process with an organization’s preventive maintenance activities. for communicating changes in the condition of a patient, a poorly designed emergency call system, and an inadequate Understand the Relationships Between assessment process can all be root causes of a patient’s fall Common and Special Causes from bed. Organizations that are successful in effectively Health care organizations need to delineate and evaluate all identifying all the root causes and their interactions can the clinical and organizational processes and subprocesses eliminate a plethora of risks when redesigning processes.5 associated with an event under review to identify the degree Elimination of one root cause reduces the likelihood of that of common-cause and/or special-cause variation. This one specific adverse outcome occurring again. However, if process will help organizations identify whether variation is the organization misses two or three other root causes, it due to clinical processes or organizational processes or both. is possible that they could interact to cause a different but equally adverse outcome. 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 TIP special cause could be uncontrollable factors. For example, Organizations must steer clear of the “myth of one a patient death results from a hospital’s total loss of elec- root cause” and expect to find several possibilities. trical 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 Benefits of Root Cause Analysis may be able to do little to prevent a future power outage All health care organizations experience problems of varying and more deaths. However, the power outage and resulting persistence and magnitude. Organizations can improve the death can also be viewed as the result of a common cause in efficiency and effectiveness of their operations and the the organization’s system for preparing for and responding quality and safety of care through addressing the roots of to a utility failure and other emergencies. Perhaps the such problems. Individual accountability for faulty perfor- backup generator that failed was located in the basement, mance should not be the focus of a root cause analysis. (See which flooded during the storm, and the organization had Chapter 3 for additional discussion of individual account- no contingency plan for such a situation. ability.) If a question arises regarding whether an individual acted appropriately, it should be addressed through the When looking at the chain of causation, proximate or organization’s employee or physician performance manage- direct causes tend to be nearest to the origin of the event. ment system. For the purpose of an RCA, the focus should For example, proximate causes of a medication error may be on systems—how to improve systems to prevent the include an outdated drug, product mislabeling or misiden- occurrence of sentinel events or problems. This approach tification, or an improper administration technique. By involves digging into the organization’s systems to find new contrast, root causes are systemic and appear far from the ways to do things. Root cause analysis helps organizations origin of the event, often at the foundation of the processes identify risk or weak points in processes, underlying involved in the event. For example, root causes of a medi- or systemic causes, and corrective actions. Moreover, cation error might include manufacturer’s production or information from RCAs shared between and among labeling of two different types or strengths of drugs so organizations can help prevent future sentinel events. that one looks too much like the other. Root causes might Knowledge shared in the health care field can contribute also include storage setup that places different dosages of to proactive improvement efforts and yield results across the same medication too close together, an inadequate the health care delivery system. 9 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 Root cause analysis is designed to answer the following action plan implemented by the organization to reduce the three questions: risk of similar events occurring and increase the likelihood 1. What happened? of positive outcomes in the future. The plan should address 2. Why did it happen? responsibility for implementation, oversight, pilot testing 3. What can be done to prevent it from happening again? as appropriate, time lines, and strategies for measuring the effectiveness and sustainability of actions. The Need for Follow Up The problem, however, is that health care organizations The Root Cause Analysis and Corrective frequently use root cause analysis to answer these questions Action Plan: Doing It Right but never determine whether the risk of recurrence of an How can an organization ensure that its RCA and correc- adverse event has actually been reduced. Therefore, some tive action plan represent an appropriate response to a health care organizations may dedicate resources to root particular sentinel event? The Joint Commission and cause analysis without knowing whether the investment has JCI provide guidance to organizations conducting RCAs any payoff. To make root cause analysis more useful, orga- in their respective sentinel event policies. These policies nizations should utilize follow-up activities that measure provide criteria that organizations can use to evaluate their the implementation of process changes and improvements RCA for strength of action, acceptability, thoroughness, and in patient outcomes. Follow-up activities should become a credibility. Organizations can use the tool in Figure 1-3, standardized component of the process.6 pages 12–13, to review their RCAs based on these criteria.

Improvement Challenges Developing a Causal Statement To ensure that the RCA yields improvement, health care Being able to focus in on root causes and succinctly define leaders must address fundamental challenges that can them sets the foundation for the remainder of the RCA. limit the value of the incident investigation. The litera- The Joint Commission identifies patterns for risk-reduc- ture has highlighted potential challenges and opportuni- tion activities by reviewing root cause analyses of sentinel ties for improvement with RCA in health care including events. This information may benefit organizations devel- the following7: oping their own corrective action plans. Organizations will need to establish guidelines when identifying and docu- • Improving how we measure the impact of improvements menting specific systems flaws that lead to sentinel events. made following an RCA with reducing the risk of Table 1-1, page 14, provides organizations with the “five future events rules of causation,” as defined in RCA2, along with samples • Redesigning the process and the tools used to conduct of incorrect and correct ways to capture root causes in their an RCA documented analyses. • Increasing the level of involvement from organization leadership Crafting an Acceptable Corrective • Focusing on stronger corrective actions Action Plan • Measuring implementation and impact of corrective The Joint Commission and JCI also provide criteria for actions on outcomes an acceptable corrective action plan within their sentinel • Making room for an abbreviated incident review event policies. According to the Joint Commission policy, when appropriate a corrective action plan will be considered acceptable if it does the following: The Joint Commission takes this and other feedback and • Identifies changes that can be implemented to reduce data into consideration as it continuously adjusts and risk or formulates a rationale for not undertaking such improves the way it works with health care organizations changes to maximize their response to sentinel events, and it is • Identifies, in situations in which improvement actions reflected in this book on root cause analysis. Consider the are planned, the following: 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 the systemic causal factors associated with each step an event lies they also can provide investigators with in the sequence that led to the sentinel event, keep a starting point for improvement planning by allowing asking why. Break down work processes to understand them to track performance before and after changes to systemic and process-related causes. Then, follow the systems and processes occur. causal chain upstream to find the causative factors and ►► Inquire into all areas appropriate to the specific root cause of the event. type of event . The root cause analysis team should ►► Focus the analysis on systems and processes, consider where else in the organization or facility the not solely on individual performance . Because underlying conditions that led to the incident prevail. root cause analysis is a process focused on finding When an effective corrective action is identified, it can out why an adverse event occurred, as opposed to then be applied on an organizationwide basis. assigning blame or responsibility for it, keep your focus ►► Identify risk points and their potential contributions on systems and processes, rather than on individual to this type of event . Here again a careful analysis of performance. This focus not only lends clarity to the processes and systems will help investigators identify work, it also encourages staff to take part in an honest which parts of tasks or processes carry inherent risk analysis of the causes of adverse events, which in for events such as the one under investigation. turn leads to better results and a reinforcement of the culture of safety. ►► Determine potential improvements in processes or systems that would tend to decrease the likelihood ►► Determine the human and other factors most of such events in the future, or determine, after directly associated with the sentinel event and the analysis, that no such improvement opportunities process(es) and systems related to its occurrence . exist . Armed with the information gained through the Investigators and staff involved in the incident may root cause analysis process, the team should create have a variety of ideas as to what caused the event, a corrective action plan that explains how the orga- and investigators should consider each of these ideas. nization can decrease the likelihood of a recurrence. Using the data collection and analysis tools in this The plan should be specific and include methods for book, the root cause analysis team can determine monitoring implementation, compliance, and mainte- which of the possible causes contributed to the nance. Data analysis and change management tools event. This data-driven approach yields credible, in Chapter 7 can help the team adopt improvements, actionable information. monitor whether those changes are being implemented ►► Use the analysis to help determine where redesign and having the desired effects, and follow through to might reduce risk . Data analysis tools can not only make sure the changes stick.

Source: Adapted from The Joint Commission, 2017 Comprehensive Accreditation Manual for Hospitals, Oak Brook, 2017.

–– Who is responsible for implementation TIP –– When the action will be implemented (including any pilot testing) An organization can seek clarification of any questions about The Joint Commission’s –– How the effectiveness of the actions will be evaluated Sentinel Event Policy and the requirements for –– The point at which alternative actions will be a comprehensive systematic analysis by visiting considered if improvement targets are not met http://www.jointcommission.org/sentinel_event _policy_and_procedures/. Note that The Joint Table 1-2, page 15, highlights sample questions that might Commission will not give a determination of be used when investigating a medication error, one of the reviewability at this point but can answer questions top reviewed sentinel events by The Joint Commission. and provide support (see also the Appendix for related information).

11 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Figure 1-3 . Root Cause Analysis Evaluation Checklist DOWNLOAD

Follow-Up Action Follow-Up Action Acceptability Y N N/A Required? 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.

Follow-Up Action Follow-Up Action Thoroughness Y N N/A Required? Completed (Date) 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

Follow-Up Action Follow-Up Action Credibility Y N N/A Required? 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 TIP steps involved in performing a thorough and credible root cause analysis and corrective action plan. (These 21 steps Use a WWW (What, Who, When): The WWW is are explored in Chapters 3 to 6.) Overall, a thorough and an action planning tool that captures the tasks that need to be completed, who is responsible, credible root cause analysis should do the following: and when they can get it done. Teams can use a • Be clear (understandable information) WWW to keep track of next steps that come out of • Be accurate (validated information and data) team meetings, and/or as an ongoing document. • Be precise (objective information and data) The tool consists of a simple grid, such as in the • Be relevant (focus on issues related or potentially related example below. The first column lists the individual to the sentinel event) responsible for the action, the second lists the • Be complete (cover all causes and potential causes) action itself, and the third indicates a due date. • Be systematic (methodically conducted) Columns can be added to track status or capture notes if necessary. (A WWW template is available • Possess depth (ask and answer all of the relevant “Why” in the e-book DOWNLOAD or on the flash drive.) questions) • Possess breadth of scope (cover all possible systemic WHO WHAT WHEN factors wherever they occur)

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 appro- priate tools and techniques for root cause analysis. Also, evaluation tool such as the Root Cause Analysis Evaluation team leaders can assess the quality of the analysis using an Checklist (see Figure 1-3, above).

13 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 An overworked resident’s fatigue led to relationship . misreading medication dosing orders and could result in patient overdose. The pump user’s instructions are not Use specific and accurate descriptors The manual’s close spacing and lack of written well. for what occurred, rather than negative graphics led to little use and could result and vague words . in incorrect use of a pump. The resident used a wrong dosage, Human errors must have a preceding The computer system’s drug dosage resulting in a patient’s overdose. cause . program leaves little space between dosage options and could result in a resident selecting an incorrect dose.

Technicians did not follow proper CT scan Violations of procedure are not root Area distractions such as noise and procedures and patient suffered a fatal air causes, but must have a preceding mismanagement led to a skipped step in a embolism. cause . 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 Failure to act is only causal when there An incomplete assignment list and in a timely way, resulting in delayed is a pre-existing duty to act . confusion about RN responsibilities could anticoagulation therapy and a potential result in an RN missing a STAT order and blood clot. 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?

15 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Sidebar 1-5 . References Steps in Conducting a Root 1. Reason J. Human error: Models and management. BMJ. 2000 Mar 18;320(7237):768–770. Cause Analysis and Implementing a Corrective Action Plan 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: 1. Organize a team Jossey-Bass, 2000, 179–198. 2. Define the problem 3. The Joint Commission: Failure Mode and Effects Analysis in 3. Study the problem Health Care: Proactive Risk Reduction, 3rd ed. Oak Brook, IL: 4. Determine what happened Joint Commission Resources, 2010. 5. Identify contributing process factors 4. Department of Veterans Affairs, Veterans Health Administration, 6. Identify other contributing factors VHA Patient Safety Improvement Handbook 1050.01, 7. Measure—collect and assess data on proximate May 23, 2008. and underlying causes 5. Knudsen P, et al. Preventing medication errors in community 8. Design and implement immediate changes pharmacy: Root-cause analysis of transcription errors. Qual Saf 9. Identify which systems are involved—the Health Care. 2007 Aug;16(4):285–290. root causes 6. Wu AW, Lipshutz AK, Pronovost PJ. Effectiveness and 10. Prune the list of root causes efficiency of root cause analysis in medicine. JAMA. 2008 Feb 13;299(6):685–687. 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 12. Explore and identify risk-reduction strategies Safety Network. Available at: https://psnet.ahrq.gov/perspectives 13. Formulate improvement actions /perspective/216. Jan 2017. 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

Learning Objectives • What issues should be considered as an organization develops its own sentinel event policy? • Become familiar with The Joint Commission’s Sentinel Events Policy and that of Joint • How should an organization respond after a Commission International sentinel event? • Who must be notified after a sentinel event occurs? • Understand the differences among types of • What are the legal and ethical considerations of patient safety events disclosure to patients? • Learn how to develop a sentinel event policy for the organization Although the answers to these questions tend to be organi- • Explore the components and value of leadership zation-specific, some general guidelines can be useful. This and a culture of safety in reducing variation chapter provides such guidelines, but organizations should in performance and the occurrence of patient consult additional sources of information as needed. safety events • Learn the importance of keeping medical record The Range of Adverse Events in Health Care documentation of errors or sentinel events for The Joint Commission’s Sentinel Event Policy is designed continuity of care 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 Root cause analysis (RCA) plays a key role in the iden­ The Joint Commission that enables it to learn about the tification and prevention of sentinel events. A number relative frequencies and underlying cause(s) of sentinel of questions arise in considering sentinel events, such as events and to share “lessons learned” with other health care the following: organizations. This transparency helps reduce the risk of • What is a sentinel event and how does it differ from future sentinel events in other organizations. Organizations other events, incidents, or occurrences that take place outside the United States accredited by JCI are guided by routinely in health care organizations? a similar Sentinel Event Policy. A comparison of the Joint • What role does an organization’s culture play in the Commission and JCI policies appears later in this chapter. identification and prevention of adverse events? The Joint Commission defines sentinel event as a patient • What do The Joint Commission and Joint Commission safety event (not primarily related to the natural course of International (JCI) require when a sentinel event occurs? the patient’s illness or underlying condition) that reaches • What types of events require comprehensive systematic a patient and results in any of the following: analysis, such as an RCA?

17 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

• Death Sidebar 2-1 . • Permanent harm Classification of Patient Safety Events • Severe temporary harm* ►► Patient safety event: an event, incident, or condi- Responding to a Sentinel Event tion that could have resulted or did result in harm to Sentinel events signal a need for immediate investigation a patient and response. All sentinel events must be reviewed by ►► Adverse event: a patient safety event that resulted the organization and are subject to review by The Joint in harm to a patient Commission. Accredited organizations are expected to ►► Sentinel event: a patient safety event (not primarily identify and respond appropriately to all sentinel events related to the natural course of the patient’s illness (as defined by The Joint Commission) occurring in the or underlying condition) that reaches a patient organization or associated with services that the organi- and results in death, permanent harm, or severe zation provides. An appropriate response includes all of temporary harm the following: ►► No-harm event: a patient safety event that reaches • A formalized team response that stabilizes the patient, the patient but does not cause harm discloses the event to the patient and family, and ►► Close call*: a patient safety event that did not reach provides support for the family as well as staff involved the patient in the event • Notification of organization leadership ►► Hazardous (or “unsafe”) condition: a circumstance • Immediate investigation (other than a patient’s own disease process or condition) that increases the probability of an • Completion of a comprehensive systematic analysis for adverse event identifying the causal and contributing factors • Strong corrective actions derived from the identified * Also referred to as a near miss. Close call is the preferred term. causal and contributing factors that eliminate or control system hazards or vulnerabilities and result in sustainable improvement over time of a defective system or process design, a system breakdown, • Time line for implementation of corrective actions equipment failure, or human error. • Systemic improvement • Ongoing measurement and assessment that corrective Signals of Risk: Close Calls and actions had the desired and maintained effect on No-Harm Events the process Fortunately, the majority of patient safety events cause no harm. For example, missed medication dosages or dosages Sentinel events are one type of patient safety event, which administered at the wrong time rarely result in death or is an event, incident, or condition that could have resulted serious permanent or temporary harm. However, these or did result in harm to a patient. Patient safety events also events may signal the presence of a much larger problem. include adverse events, no-harm events, close calls, and Organizations should integrate information about such hazardous conditions. (See Sidebar 2-1 for definitions.) A events as part of their ongoing data collection and analysis. patient safety event can be, but is not necessarily, the result A close call does not result in serious harm, but easily could * Severe temporary harm is critical, potentially life-threatening harm have. For example, suppose a nurse was about to admin- lasting for a limited time with no permanent residual, but requires ister medication to a patient via the incorrect route, such transfer to a higher level of care/monitoring for a prolonged period of as intravenously rather than orally, when she notices the time, transfer to a higher level of care for a life-threatening condition, or additional major surgery, procedure, or treatment to resolve the discrepancy in the order and holds off on giving the patient condition. Adapted from Healthcare Performance Improvement, LLC. the medication so that the issue can be resolved. The patient The HPI SEC & SSER Patient Safety Measurement System for Healthcare, rev. 2. Throop C, Stockmeier C. May 2011. Accessed May 12, 2017. could have suffered harm if the nurse hadn’t caught the http://www.pressganey.com/docs/default-source/default-document discrepancy and perhaps would even be expected to suffer -library/hpi-white-paper---sec-amp-sser-measurement-system-rev-2 harm with a similar error. -may-2011.pdf .

18 CHAPTER 2 | Addressing Sentinel Events in Policy and Strategy

Responding to Patient Safety Events Sidebar 2-2 . The Joint Commission does not require health care organi- Understanding Error zations to conduct a comprehensive systematic analysis for a close call. However, using a root cause analysis or other Though not all sentinel events result from errors, many investigation methodology to identify the contributing do. These can include both errors of commission or factors to a close call can help organizations address any errors of omission. risk points that could lead to patient harm down the road. An error of commission occurs as a result of an action This is one example of how RCA can be used proactively to taken—for example, when surgery is performed on prevent system failures or process variations from reaching the wrong limb, when a medication is administered your patients. by an incorrect route, when an infant is discharged to the wrong family, or when a transfusion error occurs The health care organization determines how it will respond involving blood crossmatched for another patient. to patient safety events that do not meet the definition of An error of omission occurs as a result of an action not a sentinel event. For example, adverse events (which may taken—for example, when a delayed diagnosis results or may not result from an error) should result in prompt in a patient’s death, when a medication dose ordered is notification of organization leaders, investigation, and not given, when a physical therapy treatment is missed, or when a patient suicide is associated with a lapse in corrective actions, according to the organization’s process carrying out frequent observation. for responding to patient safety events that do not meet the definition of a sentinel event. An adverse event may or may Errors of commission and omission may or may not not result from an error. (See Sidebar 2-2 for a discussion lead to adverse outcomes. For example, suppose a patient in seclusion is not monitored during the first of error.) two hours. The staff corrects the situation by beginning regular observations as specified in organization policy. TIP The possibility of failure is present, however, and the mere fact that the staff does not follow organization Track no-harm events, close calls, and hazardous policy regarding seclusion, and thereby violates accept- conditions and use them as opportunities to learn. able professional standards, signals the occurrence of a (Leadership standards require the scope of the failure requiring study to ensure that it does not happen safety program to include the full range of safety again. In this case, the error of omission was insufficient issues, from potential or no-harm errors [sometimes monitoring. If the patient suffers serious physical or referred to as close calls or good catches] to psychological harm during seclusion, the sentinel event hazardous conditions and sentinel events.) is the patient’s adverse outcome. By definition, sentinel events require further investiga- Which Events Does The Joint tion each time they occur. Commission Review? The Sentinel Event Policy requires organizations to conduct The Joint Commission’s Sentinel a comprehensive systematic analysis, such as an RCA, if a Event Policy sentinel event occurs. Reporting the sentinel event to The To best develop and implement a sentinel event policy Joint Commission is voluntary, but strongly encouraged. 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 The information provided here is current as of the time of death, permanent harm, or severe temporary harm (see this book’s publication. The Sentinel Event Policy appears Sidebar 2-3, page 20). Organizations should respond to in the “Sentinel Events” chapter of the Comprehensive these events the same way they would to any other Accreditation Manual for each accreditation program. sentinel event. 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 ►► Severe maternal morbidity (not primarily related to the events are considered sentinel, even if the event did not natural course of the patient’s illness or underlying cause death or severe harm: condition) when it reaches a patient and results in permanent harm or severe temporary harm║ ►► Suicide of any patient receiving care, treatment, and services in a staffed around-the-clock care setting or * Sexual abuse/assault (including rape) as a sentinel event is defined as nonconsensual sexual contact involving a patient and another patient, staff within 72 hours of discharge, including from the emer- member, or other perpetrator while being treated or on the premises of gency department (ED) 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. ►► Unanticipated death of a full-term infant One or more of the following must be present to determine that it is a sentinel event: ►► Discharge of an infant to the wrong family • Any staff-witnessed sexual contact as described above • Admission by the perpetrator that sexual contact, as described above, ►► Abduction of any patient receiving care, treatment, occurred on the premises and services • Sufficient clinical evidence obtained by the hospital to support allegations of unconsented sexual contact

►► Any elopement (that is, unauthorized departure) of a † Invasive procedures, including surgery, on the wrong patient or at the patient from a staffed around-the-clock care setting wrong site or that is the wrong procedure are reviewable under the policy, (including the ED), leading to death, permanent harm, regardless of the type of the procedure or the magnitude of the outcome. 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 ►► Hemolytic transfusion reaction involving administration room under anesthesia. This definition is based on the premise that a of blood or blood products having major blood group failure to identify and correct an unintended retention of a foreign object prior to that point in the procedure represents a system failure, which incompatibilities (ABO, Rh, other blood groups) requires analysis and redesign. It also places the patient at additional risk by extending the surgical procedure and time under anesthesia. If a foreign ►► Rape, assault (leading to death, permanent harm, or object (for example, a needle tip or screw) is left in the patient because of severe temporary harm), or homicide of any patient a clinical determination that the relative risk to the patient of searching for receiving care, treatment, or services while on site at 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* 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 ►► Rape, assault (leading to death, permanent harm, example, by type of procedure, by type of retained item, by manufacturer, or severe temporary harm), or homicide of a staff by practitioner) that may identify opportunities for improvement.

member, licensed independent practitioner, visitor, or § Fire is defined as a rapid oxidation process, which is a chemical reaction vendor while on site at the organization resulting in the evolution of light and heat in varying intensities. A combus- tion process that results in smoldering condition (no flame) is still classified ►► Invasive procedure, including surgery, on the wrong as fire. Source: National Fire Protection Association. NFPA 901: Standard patient, at the wrong site, or that is the wrong (unin- Classifications for Incident Reporting and Fire Protection Data. Quincy, MA: NFPA, 2015. tended) procedure†  Severe maternal morbidity is defined, by the American College of ►► Unintended retention of a foreign object in a patient Obstetrics and Gynecology, the US Centers for Disease Control and after an invasive procedure, including surgery‡ Prevention, and the Society of Maternal-Fetal Medicine, as a patient safety event that occurs from the intrapartum through the immediate postpartum ►► Severe neonatal hyperbilirubinemia (bilirubin > 30 period (24 hours), requiring the transfusion of four or more units of packed milligrams/deciliter) 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 ►► Prolonged fluoroscopy with cumulative dose > 1,500 24-hour medical supervision and is able to provide mechanical ventilation or continuous vasoactive drug support. Ongoing vigilance to better identify rads to a single field or any delivery of radiotherapy to patients at risk—and timely implementation of clinical interventions consis- the wrong body region or > 25% above the planned tent with evidence-based guidelines—are important steps in the ongoing radiotherapy dose provision of safe and reliable care. Appropriate systems improvements can be informed by identifying occurrences of maternal morbidity, reviewing ►► Fire, flame, or unanticipated smoke, heat, or flashes the cases, and analyzing the findings. For additional details, see “Update: § Revised Definition of Severe Maternal Morbidity in Sentinel Event Policy,” occurring during an episode of patient care June 2015 Perspectives. ►► Any intrapartum (related to the birth process) maternal death

20 CHAPTER 2 | Addressing Sentinel Events in Policy and Strategy which may include updates to the Sentinel Event Policy. TIP Changes to policy are reported in The Joint Commission Perspectives®, which is accessible via your organization’s For more than 60 years, The Joint Commission Joint Commission Connect™ extranet site. For more informa- has been a champion of patient safety by helping tion about The Joint Commission’s Sentinel Event Policy, health care organizations to improve the quality and safety of the care they provide. Call the Joint visit The Joint Commission’s website at http://www Commission’s Office of Quality and Patient Safety* .jointcommission.org or call the Office of Quality and at 630-792-3700 for help with any of the following: Patient Safety at 630-792-3700. ►►Collaborative discussion and general Goals of the Sentinel Event Policy interpretation of any aspect of the Sentinel 1. To have a positive impact in improving patient Event Policy care, treatment, and services and in preventing ►►Collaborative education/guidance regarding the unintended harm comprehensive systematic analysis process, of which the root cause analysis process is the most 2. To focus the attention of an organization that has frequently used experienced a sentinel event on understanding the ►►Collaborative education/guidance regarding factors that contributed to the event (such as underlying the identification of causal factors/root causes, causes, latent conditions, and active failures in defense and the development of strong risk-reduction systems or organization culture), and on changing the strategies and corrective action plans organization’s culture, systems, and processes to reduce * The Joint Commission Office of Quality and Patient Safety was the probability of such an event in the future formerly known as The Office of Quality Monitoring. 3. To increase the general knowledge about patient safety events, their contributing factors, and strategies for prevention Reasons for Reporting a Sentinel Event to 4. To maintain the confidence of the public, clinicians, and The Joint Commission health care organizations and keep patient safety as a When an organization reports a sentinel event, The Joint priority in accredited organizations Commission or JCI is able to help it through the response process. Self-reporting a sentinel event gives organizations How The Joint Commission Becomes Aware the opportunity to work with someone who may have of a Sentinel Event more exposure to and more experience in addressing similar Each accredited US health care organization is encouraged, issues. Joint Commission patient safety specialists work but not required, to report to The Joint Commission any with a wide spectrum of health care organizations on a patient safety event that meets The Joint Commission’s regular basis to address many types of sentinel events. They definition of a sentinel event. Likewise, health care organi- lend valuable support to any and every organization that zations outside of the United States are encouraged to experiences a sentinel event (see Figure 2-2, page 23, for report sentinel events to JCI. more on reporting sentinel events).

Alternatively, the accreditor may become aware of a sentinel Any organization that experiences a sentinel event can event by some other means, such as communication from benefit from this review process. In particular, organiza- a patient, family member, or employee of the organiza- tions for which such events are very rare may see the most tion or via media reports. Sentinel event inquiries may be benefit. In these organizations, the staff may be experi- directed anonymously to the Office of Quality and Patient encing a particular event for the first time or for the first Safety. Reports of possible sentinel events set in motion time in several years (see Table 2-1, page 24, for types of The Joint Commission’s sentinel event process, as shown sentinel events that are reviewed). The Joint Commission in Figure 2-1, page 22. staff is a valuable collaborative resource due to their cumu- lative 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 Does the event meet the Organization selects alternative type for sharing of requiring analysis (proactive risk assess- criteria for a sentinel event? a comprehensive systematic analysis within 5 busi- ment) for unsafe or hazardous conditions and ness days and the submission due date is confirmed. submission of an organization response.

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 Using data Does the plan identify, in situations in which improvement actions are planned, who revises its plan with collection the is responsible for implementation, when the action will be implemented, how the help from patient organization effectiveness of the actions will be evaluated, and how the actions will be sustained? safety specialist sustains and as a second set monitors of eyes sharing improvements. lessons learned.

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 to the reduction of risk for such events in many other the organization itself. Reporting sends a message to the organizations (see Sidebar 2-4, page 25, for a discussion of public that the organization is doing all it can to prevent government reporting requirements). recurrence of a sentinel event (see Figure 2-3, page 23, for percentages of self-reported events). How to Report a Sentinel Event Reporting a sentinel event can be done online with a form Further, reporting the event enables the addition of the accessible on an organization’s secure and encrypted Joint “lessons learned” from the event to be added to The Joint Commission Connect™ extranet site. Once logged in, place Commission’s Sentinel Event Database, thereby contrib- the cursor over “Continuous Compliance Tools.” A drop- uting to the general knowledge about sentinel events and down list will appear. From this list, select “Self-Report

22 SE Statistics as of: 1/13/2017

Summary Data of Sentinel Events Reviewed by The Joint Commission

Data Limitations: The reporting of most sentinel events to The Joint Commission is voluntary and represents only a small proportion of actual events. Therefore, these data are not an epidemiologic data set and no conclusions should be drawn about the actual relative frequency of events or trends in events over time.

Total number of Sentinel Events reviewed by The Joint Commission 1995 through 2016 12946

Reported Sentinel Events by Year by Source, 2005 to 2016 1400 1246 Cumulative Percent 1200

960 936 1000 900 887 865 831 807 824 764 800 748 698 649 664 597 624 622 574 577 600 517 510 447 369 358 400 326 291 SE Statistics as of: 1/13/2017 275 279 253 207 209 234 209 165 200 142 128 45 55 21 17 26 42 24 17 12 22 29 32 0 Summary Data of Sentinel Events Reviewed by The Joint Commission 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Self Reported Other Media Total

Data Limitations: The reporting of most sentinelCHAPTER events 2 to| TheAddressing Joint Sentinel Commission Events in isPolicy voluntary and Strategy and represents only a small proportion of actual events. Therefore, these data are not an epidemiologic data set and no conclusions should be drawn about the actual Sentinel Event Outcome 2005 relative frequency of events or trends2014 in events over2015 time. 2016 2005 to 2016 # % through 2016 Type of Sentinel Event Anesthesia-RelatedFigure 2-2 Event. Sentinel Events Reported by 6The Joint Commission,7 20054 to 2016108 Patient death 5536 53.6% CriminalTotal numberEvent of Sentinel Events reviewed by47 The Joint Commission47 199532 through 2016442 Permanent harm 110 129461.1% Delay In Treatment 79 83 54 1068 Permanent loss of function 830 8.0% Dialysis-Related Event 2 0 7 19 Severe temporary harm 398 3.9% Reported Sentinel Events by Year by Source, 2005 to 2016 Elopement 6 7 9 103 Psychological impact 340 3.3% Fall1400 93 95 92 869 Unexpected additional care 2713 26.3% 1246 Cumulative Percent Fire 10 26 15 150 Unassigned*** 52 0.5% Infant1200 Abduction 0 3 2 29 Unknown 6 0.1% Infant Discharge to Wrong Family 0 0 1 4 Other 345 3.3% 960 936 Infection-Related1000 Event 12 900 13 887 2 170 Total patients impacted**** 10330 100.0% 865 Inpatient Drug Overdose 831 807 8 13 13 824 121 764 Maternal800 Death 748 11 6 7 125 698 649 664 Med Equipment-Related597 624 9 14622 10 238 574 577 Medication600 Error 517 510 20 47 33 476 Op/Post-op Complication 447 53 82 45 920 *Other settings include: Disease Specific Care, Diagnostic 369 358 Other400 Unanticipated Event** 73 326 58 47 632 Imaging, Hospice Care 275 279 291 Perinatal Death/Injury 35 234 43 253 23 362 207 209 209 **Other unanticipated event includes: Asphyxiation, Burn, Radiation Overdose 142 4 4 165 4 46 200 128 Choked on food, Drowned, Found unresponsive Restraint Related Event 45 2 55 7 7 124 21 17 26 42 24 17 12 22 29 32 Self-Inflicted0 Injury 5 21 17 100 ***Category unassigned at the time of report. Severe Maternal2005 Morbidity2006 2007 2008 2009 2010 0 2011 2012 0 2013 2014 9 2015 2016 9 Severe Neonatal Hyperbilirubinemia 0 2 0 8 ****Multiple patients may be impacted by a single event. Suicide Self Reported Other84 Media 98Total 87 1013 Transfer-Related Event 2 1 2 30 The graphTransfusion above reflects Error top sentinel events between 2005 and7 2016, the latest9 date for 5 127 which dataUnassigned*** is publicly available. 4 3 70 77 Sentinel Event Outcome 2005 Unintended Retention of a Foreign Body 2014 116 2015 123 2016 120 2005 to 20161231 # % Utility System Failure 0 1 1 9 through 2016 Type of Sentinel Event Ventilator Death 3 3 2 54 Anesthesia-Related Event 6 7 4 108 Patient death 5536 53.6% Wrong–patient, wrong-site, wrong-procedure 73 120 104 1281 Criminal Event 47 47 32 442 Permanent harm 110 1.1% Total IncidentsFigure Reviewed 2-3 . Percent Self-Reported764 of Sentinel Events,936 2005 824to 2016 9945 Delay In Treatment 79 83 54 1068 Permanent loss of function 830 8.0% Dialysis-Related Event 2 0 7 19 Severe temporary harm 398 3.9% Elopement 6 7 9 103 Psychological impact 340 3.3% Fall Percent Self-Reported of Sentinel93 Events, 2005 95to 2016 92 869 Unexpected additional care 2713 26.3% Fire 10 26 15 150 Unassigned*** 52 0.5% 90% 81% Infant Abduction 0 3 76% 2 29 Unknown 6 0.1% 72% 75% 80% 69% 71% 69% 70% Infant Discharge to Wrong Family 65% 0 0 1 4 Other 345 3.3% Infection-Related70% 62% Event 60% 61% 12 13 2 170 Total patients impacted**** 10330 100.0% Inpatient60% Drug Overdose 8 13 13 121 Maternal50% Death 11 6 7 125 Med Equipment-Related40% 9 14 10 238 Medication30% Error 20 47 33 476 Op/Post-op20% Complication 53 82 45 920 *Other settings include: Disease Specific Care, Diagnostic Percent Self Reported Other 10%Unanticipated Event** 73 58 47 632 Imaging, Hospice Care Perinatal Death/Injury 35 43 23 362 © Copyright, The Joint Commission 0% Radiation Overdose 4 4 4 46 **Other unanticipated event includes: Asphyxiation, Burn, 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Choked on food, Drowned, Found unresponsive Restraint Related Event 2 7 7 124 Self-Inflicted Injury 5 21 17 100 ***Category unassigned at the time of report. This graphSevere illustrates Maternal the Morbidity percentage of self-reported sentinel events0 between 20050 and 2016. 9 9 Severe Neonatal Hyperbilirubinemia 0 2 0 8 ****Multiple patients may be impacted by a single event. Sentinel Event”Suicide (see a screenshot of this tool in Figure 2-4, 84method for sharing98 the comprehensive87 systematic1013 analysis Transfer-Related Event 2 1 2 30 page 26). Transfusion Error and7 corrective action9 plan and will5 confirm the127 due date. Unassigned*** 4 3 70 77 The organizationUnintended will Retention be contacted of a Foreign by a Body Joint Commission 116Addressing123 Concerns About120 Reporting1231 Utility System Failure 0 1 1 9 patient safetyVentilator specialist Death to determine whether the event Concerns3 about 3potential legal issues2 can give an54 organiza- meets the definitionWrong–patient, of awrong-site, sentinel wrong-procedureevent. After the event is 73tion pause before120 reporting. Often104 the chief concern1281 is that identified Totalas a sentinel Incidents Reviewedevent, the specialist will confirm the 764a comprehensive936 systematic analysis824 will be obtained9945 and

Percent Self Reported of Sentinel23 Events, 2005 to 2016

90% 81% 76% 72% 75% 80% 69% 71% 69% 70% 65% 70% 62% 60% 61% 60% 50% 40% 30% 20% Percent Self Reported 10% © Copyright, The Joint Commission 0% 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Table 2-1. Types of Sentinel Events

Type of Sentinel Event 2014 2014 2014 2005 to 2016

Anesthesia-Related Event 6 7 4 108 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 11 6 7 125 Med Equipment-Related 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 Severe Neonatal Hyperbilirubinemia 0 2 0 8 Suicide 84 98 87 1013 Transfer-Related Event 2 1 2 30 Transfusion Error 7 9 5 127 Unassigned 4 3 70 77 Unintended Retention of a Foreign Body 116 123 120 1231 Utility System Failure 0 1 1 9

Ventilator Death 3 3 2 54 Wrong–patient, wrong-site, wrong-procedure 73 120 104 1281 Total Incidents Reviewed 764 936 824 9945 used in a lawsuit against the organization. Organizations Joint Commission becomes aware of the event, the orga­ should be aware that it would be very difficult for any nization must share relevant information with The Joint parties to obtain access to that information under any Commission. Almost all organizations experiencing circumstances. In the event of a subpoena, The Joint sentinel events appear to be moving quickly to address Commission adheres to its Public Information Policy. the first tenet. However, among other reasons, The Joint Commission has been told that serious concerns regarding Legal Concerns Over Confidentiality the potential discoverability of sentinel event–related The basic tenets of the Sentinel Event Policy are that an information shared with The Joint Commission have organization must perform a comprehensive systematic created a significant barrier to organizations meeting the analysis in response to a sentinel event and that if The second tenet.

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 New Hampshire Colorado New Jersey Connecticut New York District of Columbia Ohio Florida Oregon Georgia Pennsylvania Illinois Rhode Island Indiana South Carolina Kansas South Dakota Maine Tennessee Maryland Texas Massachusetts Utah Minnesota Vermont Nevada Washington

NASHP made the following findings:

►► The number of adverse event reporting systems has changed for the first time since 2007, withTexas 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 ­anecdotal, survey, or other sources indicating an impact on communication among facilities, provider education, internal 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. TIP These alternatives are intended to offer methods for sharing information with The Joint Commission that some lawyers If you are uncertain whether a patient safety event meets the definition of a sentinel event, err on and organizations may find provide additional comfort the side of caution by reporting the event. Self- about any potential exposure of sensitive sentinel event– reporting does not automatically mean that an related information (see Sidebar 2-5, page 27). Questions incident will be considered a sentinel event. regarding legal protections of sentinel event information can be directed to the Office of the General Counsel. The Joint Commission’s patient safety specialists Contact information under “Legal Issues” can be found can help the organization make that determination. The Joint Commission is there to help the online at https://www.jointcommission.org/contact organization through the process, and patient _directory/?CategoryId=73. safety specialists may work with the organization to identify potential solutions even if the incident does Sentinel Events That Are Not Reported not meet the definition of a sentinel event. by the Organization The Joint Commission sometimes becomes aware of a To meet these concerns, The Joint Commission offers sentinel event through other means besides self-reporting, several alternative ways for a health care organization to such as through media reports or calls from patients or their report, and The Joint Commission to review, information families. Whether the organization voluntarily reports the

26 CHAPTER 2 | Addressing Sentinel Events in Policy and Strategy

event or The Joint Commission becomes aware of the event organization is required to submit or make available an by some other means, there is no difference in the expected acceptable root cause analysis and corrective action plan, or response, time frames, or review procedures. choose an approved comprehensive systematic analysis tool within 45 calendar days of the event or becoming aware of If The Joint Commission becomes aware of a sentinel the event. event that was not reported to The Joint Commission by an accredited organization, the chief executive officer of Disclosable Information the organization, or his or her designee, is contacted, and If, during the 45-day analysis period, The Joint a preliminary assessment of the sentinel event is made. If Commission receives an inquiry about the accreditation the occurrence meets the definition of a sentinel event, the status of an organization that has experienced a sentinel

Sidebar 2-5 . Reporting Alternatives

A health care organization that self-reports a sentinel Alternative 3 event to The Joint Commission (or experiences a The organization conducts its comprehensive systematic sentinel event that is otherwise made known to The Joint analysis and creates a corrective action plan. The orga- Commission) must conduct a comprehensive systematic nization and a Joint Commission patient safety specialist analysis and create a corrective action plan that describes discuss the sentinel event and review the corrective action the organization’s risk-reduction strategies as well as plan and relevant documentation (including, at a minimum, how the effectiveness of those strategies will be evalu- any documentation relevant to the organization’s process ated. The Joint Commission created several alternatives for responding to sentinel events). The patient safety for how this information is submitted if the organization specialist may ask questions regarding the comprehen- has concerns about waiving confidentiality protections sive systematic analysis, but will not review that document as a result of sending the comprehensive systematic itself. The corrective action plan serves as the basis for analysis documents to The Joint Commission. The Joint determining appropriate follow-up activity. This review can Commission must receive a request for review of a health be performed on site at the organization or via web-based care organization’s response to a sentinel event using any video conferencing with a patient safety specialist who is of these options within five business days of the self-report located at The Joint Commission. of a sentinel event or of the initial communication by The Alternative 4 Joint Commission to the organizations that it has become A specially trained surveyor conducts a standards-based aware of a sentinel event. survey to trace patient care, treatment, and services as Alternative 1 well as the management functions relevant to the sentinel The organization conducts its comprehensive systematic event under review. The surveyor does the following: analysis and creates a corrective action plan, and organi- ►► Interviews staff zation staff bring the documents to Joint Commission headquarters for review then take them back to the ►► Reviews relevant documentation (including, if appli- organization on the same day. This review can be cable, the patient’s medical record) conducted at Joint Commission headquarters or ►► Evaluates the process the organization uses in performed via web-based video conferencing with a responding to sentinel events patient safety specialist who is located at The Joint Commission and the organization participants remain at ►► Examines the relevant policies and procedures the health care organization. preceding and following the organization’s own review of the specific event, making inferences about Alternative 2 the adequacy of the organization’s response to the The organization conducts its comprehensive systematic sentinel event analysis and creates a corrective action plan and shares the documents with a Joint Commission patient safety Each of these options will result in a fee to the specialist. This review can be conducted at the health care hospital to cover the average direct costs of the option. organization or performed via web-based video confer- Inquiries about the fee should be directed to The Joint encing with a patient safety specialist who is located at Commission’s Pricing Unit at 630-792-5115. The Joint Commission.

27 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

event, the organization’s accreditation status is reported in The Joint Commission’s website at http://www the usual manner without making reference to the sentinel .jointcommission.org. The root cause analysis and event. If the inquirer specifically references the sentinel corrective action plan are not to include the patient’s name event, The Joint Commission acknowledges that it is or the names of caregivers involved in the sentinel event. aware of the event and is working with the organization through the sentinel event review process. All comprehen- Reporting Options sive systematic analysis tools including RCAs and corrective The handling of sensitive documents regarding sentinel action plans will be considered and treated as confidential events is restricted to specially trained Joint Commission by The Joint Commission in accordance with The Joint staff in accordance with procedures designed to protect the Commission’s Public Information Policy. confidentiality of the documents. An organization that has experienced a sentinel event has several alternate methods Required Response to a Sentinel Event for sharing information with The Joint Commission. If The Joint Commission becomes aware of a sentinel event These sharing options include electronic submission and in an accredited organization, and the occurrence meets the on-site interaction: definition of a sentinel event, the organization is required to • Electronic submission. The organization submits its root do the following: cause analysis and corrective action plan via the secure • Prepare a thorough and credible comprehensive and encrypted extranet, The Joint Commission Connect™ systematic analysis and corrective action plan within (also called Alternative 0). The organization will be 45 business days of the event or of becoming aware contacted by telephone upon completion of The Joint of the event. Root cause analysis is the most common Commission’s review. type of comprehensive systematic analysis used by Joint • On-site interaction. This option involves a face- to- Commission–accredited organizations. face dialogue between the organization and The Joint • Select and provide information under an approved Commission. It may take place in one of four ways, as alternative protocol within 45 business days of the described in previous Sidebar 2-5. known occurrence of the event. The Joint Commission’s Review of the Root The Joint Commission will then determine whether the Cause Analysis and Corrective Action Plan root cause analysis and corrective action plan are acceptable. Joint Commission staff members assess the acceptability of If the determination that an event is sentinel occurs more an organization’s response to a sentinel event, including the than 45 business days following the known occurrence of thoroughness and credibility of any root cause analysis the event, the organization will be allowed 15 calendar days information reviewed and the organization’s corrective for its response. action plan. A corrective action plan will be acceptable if it meets the following criteria: Submission of Root Cause Analysis and • Identifies and implements actions to eliminate or control Corrective Action Plan systems hazards or vulnerabilities An organization that experiences a sentinel event is required • Identifies, in situations in which improvement actions to complete two documents: are planned, who is responsible for implementation, 1. The root cause analysis, which includes enough detail to when the action will be implemented, how the demonstrate that the analysis is thorough and credible effectiveness of the actions will be evaluated, and how 2. The resulting corrective action plan that describes the the actions will be sustained organization’s risk-reduction strategies and plan for • Identifies at least one stronger or intermediate strength evaluating their effectiveness. action for each root cause analysis

A framework for a root cause analysis and corrective action If the root cause analysis or corrective action plan is not plan (see the Appendix) is available to organizations as an acceptable, The Joint Commission will work with the orga- aid in organizing the steps in a root cause analysis and nization to facilitate development of a thorough and cred- developing a corrective action plan. It is also available on ible root cause analysis and corrective action plan.

28 CHAPTER 2 | Addressing Sentinel Events in Policy and Strategy

Follow-Up Activity of information sharing. In handling sentinel event–related Through the completion of the root cause analysis, the documents, The Joint Commission destroys original root organization is able to identify important contributing cause analysis documents and any copies, or, upon request, factors to a sentinel event. The organization develops a returns the original documents to the organization. In corrective action plan to mitigate the possible recurrence of accordance with procedures designed to protect the confi- such an event. The measure of success (MOS) process for all dentiality of the documents, only specially trained Joint accreditation and certification programs in response to Commission staff handle these sensitive documents. requirements for improvement found onsite was discon- tinued January 1, 2017, as part of the changes to the The corrective action plan resulting from the analysis of post-survey follow-up process under Project REFRESH. the sentinel event is initially retained to serve as the basis for However, the Sentinel Event MOS process is unchanged the follow-up activity. After the organization implements the and still in effect. The Joint Commission requires that corrective action plan to the satisfaction of The Joint organizations measure the effectiveness of improvement Commission, as determined through follow-up activities, The activities. This measurement is most frequently accom- Joint Commission also destroys the corrective action plan. plished through a Sentinel Event Measure of Success (SE MOS). An SE MOS is a numerical or quantifiable measure Joint Commission International’s Sentinel usually related to an audit that determines if a planned Event Policy action was effective and sustained. (In some instances, The The JCI Sentinel Event Policy, applicable to accredited Joint Commission will consider other forms of mutually organizations outside the United States, has similarities to agreed-upon follow-up activities to evaluate the effective- that of The Joint Commission.1 (For a comparison of the ness of a corrective action plan.) two sentinel event policies, see Table 2-2, pages 32–33).

Upon the organization’s submission of SE MOS data indi- Reporting of sentinel events to JCI is voluntary but encour- cating sustainability of the improvement efforts, The Joint aged. JCI’s definition of a sentinel event takes into account Commission will close the file as complete. The informa- a wide array of occurrences applicable to a wide variety tion will be de-identified and entered into the Sentinel of health care organizations. Sentinel events are unantici- Event Database, as discussed in the following section. pated occurrences that involve death or serious physical or psychological injury. Such events include but are not The Sentinel Event Database limited to the following, which are subject to review by JCI: To achieve the third goal of the Sentinel Event Policy—to • Unanticipated death, including but not limited to increase the general knowledge about sentinel events, their death unrelated to the natural course of the patient’s causes, and strategies for prevention—The Joint illness or underlying condition, death of a full-term Commission collects and analyzes data from the review of infant, and suicide sentinel events, root cause analyses, corrective action plans, • Major permanent loss of function unrelated to the and follow-up activities. These data and information natural course of the patient’s illness or underlying form the content of The Joint Commission’s Sentinel condition Event Database. • Wrong-site, wrong-procedure, wrong-patient surgery • Transmission of a chronic or fatal disease or illness The Joint Commission develops and maintains the Sentinel as a result of infusing blood or blood products or Event Database in a manner that excludes organization, transplanting contaminated organs or tissues caregiver, and patient identifiers. • Infant abduction • Rape, workplace violence leading to death or Aggregate data relating to root causes and risk-reduc- permanent loss of function, or homicide on the tion strategies for sentinel events that occur with signifi- organization’s property cant frequency form the basis for future error-prevention advice to health care organizations through Sentinel Event If, either through voluntary reporting by the accred- Alerts, National Patient Safety Goals, and other methods ited 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, and supports those staff with quality and patient safety employees, the media, or identification by a survey team responsibilities throughout the organization. during an onsite survey), JCI becomes aware of the occur- • The quality program provides support and coordination rence of a sentinel event, then the event becomes subject to department/service leaders for like measures across to JCI’s Sentinel Event Policy. In that case, the organiza- the organization and for the organization’s priorities tion is expected to prepare a thorough and credible correc- for improvement. tive action plan within 45 calendar days of the event or of –– The quality program implements a training program becoming aware of the event and then submit its root cause for all staff that is consistent with staff’s roles in the analysis and corrective action plan to JCI for evaluation. quality improvement and patient safety program. JCI then determines whether or not the plans are accept- –– The quality program is responsible for the regular able. All root cause analyses and corrective action plans are communication of quality issues to all staff. considered and treated by JCI as confidential. • The organization uses a defined process for identifying and managing sentinel events. A root cause analysis will be considered acceptable by JCI • Organization leadership has established a definition of if it has the following characteristics: a sentinel event that at least includes the occurrences in • The analysis focuses primarily on systems and processes, the box below (see Standard QPS.7 in the JCI Hospital not individual performance. Standards, 6th Edition). • The analysis progresses from specific causes in the • The organization completes a root cause analysis of all clinical care process to common causes in the sentinel events in a time period specified by organization organizational process. leadership that does not exceed 45 days from the date of • The analysis repeatedly digs deeper. the event or when made aware of the event. • The analysis identifies changes that could be made • Organization leadership takes action on the results of the in systems and processes (either through redesign or root cause analysis. development of new systems or processes) that would • Those responsible for governance approve the reduce the risk of such events occurring in the future. organization’s program for quality and patient safety and regularly receive and act on reports of the quality and Although reporting a sentinel event to JCI is voluntary, an patient safety program. organization may be required to report sentinel events to a –– Those responsible for governance annually governmental or private agency within its country. approve the organization’s program for quality and patient safety. Related Joint Commission –– Those responsible for governance at least quarterly International Standards receive and act on reports of the quality and patient Quality Improvement and Patient Safety (QPS) standards safety program, including reports of adverse and require that qualified individuals guide the implementation sentinel events. of the organization’s program for quality improvement and –– Minutes reflect actions taken and any follow-up on patient safety and manage the activities needed to carry out those actions. an effective program of continuous quality improvement • Organization leadership communicates quality and patient safety within the organization. improvement and patient safety information to governance and organization staff on a regular basis. Additional requirements include the following: –– Organization leadership reports on the quality and • An individual(s) who is experienced in the methods patient safety program quarterly to governance. and processes of improvement is selected to guide the –– Organization leadership reports to governance implementation of the organization’s quality and patient include, at least quarterly, the number and type of safety program. sentinel events and root causes, whether the patients • The individual(s) with oversight for the quality program and families were informed of the sentinel event, selects and supports qualified staff for the program actions taken to improve safety in response to sentinel events, and if the improvements were sustained.

30 CHAPTER 2 | Addressing Sentinel Events in Policy and Strategy

–– Information on the quality improvement and patient • All unusual events, even though they may result in only safety program is regularly communicated to staff, minor adverse outcomes including progress on meeting the International • All events that must be reported to an external agency Patient Safety Goals. • Events with potential for an adverse public, economic, or • The organization integrates the human subjects research regulatory impact program (as applicable) into the quality and patient safety program of the organization. An organization’s definition should, at a minimum, include • The research program is a component of the those events that meet the definition of a sentinel event organization’s processes to report and act on sentinel under The Joint Commission’s Sentinel Event Policy or events, adverse events of other types, and the processes to for international accredited organizations, the require- learn from close calls. ments of the sentinel event standard in the JCI standards. • The research program is included in the organization’s The definition should also apply organizationwide and programs for hazardous material management, medical should appear in writing in an organization plan or policy. technology management, and medication management. Through a collaborative process, organization leaders as well • The evaluation of staff participating in the research as medical, nursing, and administrative staff should develop program is incorporated into the ongoing monitoring the definitions or categories of events that warrant root processes of professional performance. cause analysis.

Developing Your Own Sentinel Event Policy In developing the organization’s sentinel event policy, Although The Joint Commission requires organizations to leaders may also address the process for reporting a sentinel define the term sentinel event and communicate its defi- event to leadership, how organizations should handle close nition throughout the organization, it does not require calls, and the process for the ongoing management of organizations to develop a sentinel event policy. The infor- patient safety events and prevention efforts. mation provided here is intended to provide advice on how an organization might develop a sentinel event policy if it Leaders may also wish to identify the following: wishes to do so. Both US–based and international health • The individual responsible for receiving initial care organizations should consider developing their own notification of a sentinel event sentinel event policy. The first step in developing an organi- • The individual responsible for assessing whether or not zation’s sentinel event policy is to determine which patient the event warrants an in-depth root cause analysis based safety events warrant in-depth analysis. on the organization’s definition of a sentinel event (this may be the same individual—for example, a physician, The Joint Commission expects accredited organizations to risk manager, quality assurance coordinator, or program identify and respond appropriately to all sentinel events, as manager) defined by The Joint Commission and the organization, • How this individual communicates the need for in- occurring in the organization or associated with services depth investigation and necessary information to a team that the organization provides or provides for. Doing so of individuals responsible for performing the root cause helps ensure improvement of the organization’s processes. analysis As outlined earlier, appropriate response includes a thor- • The individual responsible for facilitating and overseeing ough and credible RCA, implementing improvements a team-based root cause analysis process to reduce risk, and monitoring of the effectiveness of those improvements. Safe Reporting However the organization designs its sentinel event policy, Defining a Sentinel Event it is critical that the process be transparent. Transparency An organization may wish to define a sentinel event as a builds trust within the organization and encourages staff to serious event involving staff and visitors as well as patients. report errors, adverse events, and dangerous conditions. The Or an organization may wish to include the following: culture of safety propagated by an open, honest reporting

31 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 Joint Commission International (JCI) Sentinel Event Event Policy Policy and Related Requirements Definition of Sentinel A patient safety event (not primarily related to the An unanticipated occurrence involving death or Event natural course of the patient’s illness or underlying serious physical or psychological injury. Serious condition) that reaches a patient and results in any physical injury specifically includes loss of limb or of the following: function. • Death • Permanent harm • Severe temporary harm Other Information Such events are called “sentinel” because they Such events are called “sentinel” because they About Sentinel signal the need for immediate investi­gation and signal a need for immediate investigation and Events response. The terms sentinel event and medical response. The terms sentinel event and medical error are not synonymous; not all sentinel events error are not synonymous; not all sentinel events occur because of an error and not all errors result in occur because of an error and not all errors result in sentinel events. sentinel events. Goals of the Sentinel 1. To have a positive impact in improving patient 1. To have a positive impact in improving patient care, Event Policy care, treatment, and services and in preventing treatment, and services and preventing sentinel unintended harm events 2. To focus the attention of a hospital that has 2. To focus the attention of an organization that has experienced a sentinel event on understanding experienced a sentinel event on understanding the factors that contributed to the event (such as the causes that underlie that event and on underlying causes, latent conditions and active changing the organization’s systems and failures in defense systems, or hospital culture), processes to reduce the probability of such an and on changing the hospital’s culture, systems, event in the future and processes to reduce the probability of such 3. To increase general knowledge about sentinel an event in the future events, their causes, and strategies for prevention 3. To increase the general knowledge about patient 4. To maintain the confidence of the public and safety events, their contributing factors, and internationally accredited organizations in the strategies for prevention accreditation process 4. To maintain the confidence of the public, clinicians, and hospitals that patient safety is a priority in accredited hospitals Organization-specific Standards require each accredited organization to Standards require each accredited organization to Definition of Sentinel define patient safety event and communicate this establish an operational definition of sentinel event Event definition throughout the organization. At a minimum, and a process for the in-depth analysis of such an organization’s definition must encompass sentinel events. events as defined by The Joint Commission. An When developing the definition, accredited accredited organization is encouraged to include organizations must include at least those events in its definition events, incidents, and conditions in that are described in the sentinel event standard which no or only minor harm occurred to a patient. within the JCI standards. Such events include The hospital determines how it will respond to death related to the natural course of the patient’s patient safety events that do not meet the Joint illness or underlying condition; major permanent Commission definition of a sentinel event. 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.

32 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 Joint Commission International (JCI) Sentinel Event Event Policy Policy and Related Requirements Self-Reporting a Encouraged but not required Encouraged but not required Sentinel Event Sentinel Events All sentinel events must be reviewed by the Accredited organizations are expected to identify organization and are subject to review by The Joint and respond appropriately to all sentinel events Commission. occurring in the organization or associated with services that the organization provides. Expectations for Prepare a thorough and credible root cause analysis Appropriate response includes conducting a an Organization’s and corrective action plan within 45 business days of timely, thorough, and credible root cause analysis; Response to a the event or of becoming aware of the event. developing an action plan designed to implement Sentinel Event 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 All root cause analyses and action plans will be will be considered and treated as confidential by considered and treated as confidential by JCI. The Joint Commission in accordance with the Joint Commission’s Public Information Policy. Follow-Up to Review Organizations are required to measure the Upon acceptance of the organization’s root effectiveness of the improvement activities outlined cause analysis and action plan, JCI will assign an in the corrective action plan accepted by The appropriate follow-up activity, typically a written Joint Commission. This measurement is done progress report due in four months. 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. and investigative process, one that focuses on systems Staff Orientation and Training and processes, is a necessary condition for creating a high Following the development of the organization’s sentinel reliability organization. event policy, leaders should ensure that all staff and physi- cians are knowledgeable about the organization’s sentinel Addressing Discoverability and Disclosure event policies and procedures. In-service programs and Leaders should also address confidentiality, discoverability, new staff and physician orientation should address the and disclosure. Information obtained during the investiga- organization’s sentinel event policy on a regular and tion of sentinel events through RCA or other techniques continuing basis, including regular updates concerning is often highly sensitive. The organization’s sentinel event sentinel events published by The Joint Commission and policy should address how confidentiality will be protected. additional issues that may be identified through the The policy should also address the procedure for obtaining organization’s compliance with the National Patient Safety legal consultation to protect relevant documents such as Goals. Figure 2-5 provides a checklist that outlines the steps meeting minutes, reports, and conversations from discovery described in this section. in the event of a future lawsuit. The policy should be clear on whether the state in which the organization operates Leadership, Culture, and Patient protects the details of a sentinel event investigation from Safety Events discovery under the organization’s quality management, For the sentinel event policy to be effective, the culture of peer review, or risk management programs. 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 DOWNLOAD

Defining Y N N/A Comments 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 Y N N/A Comments 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 Y N N/A Comments 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).

34 CHAPTER 2 | Addressing Sentinel Events in Policy and Strategy

DOWNLOAD the prevention and identification of sentinel events, Figure 2-6 . 11 Tenets of a Safety Culture as described in The Joint Commission’s Sentinel Event Alert #57 entitled “The Essential Role of Leadership in Definition of Safety Culture Safety culture is the sum of what an organization is Developing a Safety Culture” (see the central tenets of the and does in the pursuit of safety. The Patient Safety Alert in Figure 2-6). Systems (PS) chapter of The Joint Commission accreditation manuals defines safety culture as the Leadership product of individual and group beliefs, values, atti- Leaders must be deeply committed to patient safety and to tudes, perceptions, competencies, and patterns of ensuring that members of their organization truly embody behavior that determine the organization’s commitment their mission, vision, and values. They play a critical role in to quality and patient safety. fostering an organization culture in which patient safety 1. Apply a transparent, nonpunitive approach to reporting event reporting, root cause analyses, and proactive risk and learning from adverse events, close calls, and unsafe conditions. reduction are encouraged. Competent and thoughtful leaders contribute to improvements in safety and organiza- 2. Use clear, just, and transparent risk-based processes for recognizing and distinguishing human errors and system tional culture. They understand that systemic flaws exist errors from unsafe, blameworthy actions. and each step in a care process has the potential for failure 3. CEOs and all leaders adopt and model appro- simply because humans make mistakes. Reporting helps an priate behaviors and champion efforts to eradicate organization start the process of both identifying root intimidating behaviors. causes and developing and implementing risk-reduction 4. Policies support safety culture and the reporting of strategies. Leaders who understand that continuous adverse events, close calls, and unsafe conditions. These policies are enforced and communicated to all team improvement is essential to an organization’s success must members. have the authority and willingness to allocate resources for 5. Recognize care team members who report adverse root cause analyses and improvement initiatives. They must events and close calls, who identify unsafe conditions, ensure that the processes for identifying and managing or who have good suggestions for safety improvements. patient safety events are defined and implemented. They Share these “free lessons” with all team members (i.e., feedback loop). must be willing and able to set an example for the organiza- tion and empower staff to identify and bring about neces- 6. Determine an organizational baseline measure on safety culture performance using a validated tool. sary change. Effective leaders empower staff throughout the organization to acquire and apply the knowledge and skills 7. Analyze safety culture survey results from across the organization to find opportunities for quality and needed to continuously improve processes and services. safety improvement. Safety Culture 8. Use information from safety assessments and/or surveys to develop and implement unit-based quality and safety A robust safety culture is a crucial component to becoming improvement initiatives designed to improve the culture a high reliability organization—a goal for many Joint of safety. Commission–accredited organizations. An organization’s 9. Embed safety culture team training into quality improve- response to a patient safety event speaks volumes about ment projects and organizational processes to strengthen safety systems. its culture. Its response can also significantly influence the likelihood of similar events in the future. Historically, the 10. Proactively assess system strengths and vulnerabilities and prioritize them for enhancement or improvement. response to sentinel events has been to identify the individ- ual(s) most closely associated with the event and take some 11. Repeat organizational assessment of safety culture every 18 to 24 months to review progress and form of punitive action. “Who did it?” has too often been sustain improvement. the first question asked, rather than “Why did it happen?” The list above provides guidelines for leadership to implement a strong safety culture initiative in The organization that routinely asks “Why?” rather than its organization. See Sentinel Event Alert Issue 57, “Who?” will, over time, learn more about the quality and “The essential role of leadership in developing a safety of the care it is providing—as well as its sentinel safety culture,” for more information, resources, events, close calls, and hazardous conditions—and will and references.

35 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

better understand the relationship between its staff Early Response Strategies members and the processes, systems, and environment in An organization has just experienced a sentinel event which they function.2 leading to a serious adverse outcome. What must be done? Following the occurrence of a sentinel event, staff members Performance Improvement must simultaneously take a number of actions. An organi- Through commitment to performance improvement, zation’s sentinel event policy should outline early response patient safety, and proactive risk reduction, leaders build strategies. These strategies include the following: an organization culture that values change, creativity, • Providing prompt and appropriate care for the teamwork, and communication (see Sidebar 2-6, below). affected patient(s) Teams provide much of the impetus for performance • Containing the risk of an immediate recurrence of improvement. Communication and information flow the event throughout the organization to foster a barrier-free learning • Preserving the evidence environment. (See the “Patient Safety Systems” [PS] chapter in the applicable Comprehensive Accreditation Manual Appropriate Care for information on how standards provide the infrastructure The prompt and proper care of a patient who has been for these efforts.) affected by a sentinel event should be the providers’ and

Sidebar 2-6 . Root Cause Analysis Training: Case Example

DaVita Hospital Services Group provides comprehensive root cause analysis and contribute to overall patient safety 24-hour inpatient kidney care in more than 980 and quality of care. hospitals nationwide, delivering more than one million Curriculum Development treatments daily. The effort to better educate staff on root cause anal- In 2015, DaVita’s leadership noticed that its staff members ysis resulted in the development of a document titled were increasingly being asked to participate in the root “Analyzing Root Cause Analysis: It’s a Good Thing!” cause analysis (RCA) process for investigating sentinel introduced in February 2016. The document was created events at the hospitals in which they work as contractors. by DaVita’s Clinical Education and Clinical Services According to Miki Smith, national director of operations, departments and the Hospital Services Group’s medical Hospital Services, DaVita Healthcare Partners Inc., DaVita director. The document combines fictional examples performs its own root cause analysis when patient safety with Joint Commission–recommended processes into a events occur. However, she explains, many of the organi- lesson format that explains root cause analysis, why it is zation’s nursing staff did not understand the process well, important, how it is applied effectively, and its importance which led to uncertainty and fear about the process. within a culture of safety. “Some of our nurses were afraid to participate in the root “The new curriculum makes it very clear that RCA is not cause analysis process,” Smith says. “They were afraid intended to point the finger at an individual person, but of saying the wrong thing, or perhaps being blamed for to identify flaws in the process,” Smith says. She explains an incident.” that the goal is to shift the staff members’ perception of root cause analysis from “Oh no, I did something wrong” to Training Needs “Let’s figure out what happened so we can fix it.” DaVita responded by examining its staff education and training curriculum. All newly hired staff members undergo Smith says that DaVita has partnered with The Joint training before starting work. Many of the nurses have Commission to achieve this goal. Joint Commission chronic dialysis experience but do not necessarily have speakers have given presentations on a culture of safety experience in a clinical hospital environment. DaVita to the organization’s staff. Also, The Joint Commission has recognized that more information was needed to help its helped DaVita make the most of its existing programs 3,000 nurses understand and maximize the benefits of regarding a culture of safety.

36 CHAPTER 2 | Addressing Sentinel Events in Policy and Strategy

staff members’ first concern following the event. Care could Documentation involve, as appropriate, stabilizing the patient, arranging Proper medical record documentation of errors or sentinel for his or her transportation to a health care facility for events is critical for the continuity of care. A thorough surgery or testing, providing medications, taking actions incident-reporting form can be very helpful during the early to prevent further harm, and reversing the harm that has stages of event investigation and during steps 2 through occurred, if possible. When appropriate, physicians should 4 of root cause analysis (discussed in Chapters 3 and 4). obtain medical consultation related to the adverse event and Health care organizations use a variety of occurrence or arrange to receive necessary follow-up information. incident-reporting tools and generally have a policy and procedure covering their use. Forms or questionnaires may Risk Containment be general in nature, covering all types of adverse events, or Following a sentinel event, the organization must respond be specific to event types. (See Figure 2-7, page 38, for an by immediately containing the risk of the event occur- incident tracking form.) ring again. For example, if a patient suffered a stroke after receiving an incorrect drug that looked very similar Communication to the correct drug and was stored in the same area, are With the occurrence of a sentinel event, personnel involved other patients at risk for the same type of incident? If so, in the incident should promptly notify those responsible for the organization must take immediate action to safeguard error reporting and investigation within the organization. patients from a repetition of the unwanted occurrence. In They should inform supervisors, quality and risk manage- the example given, one of the two drugs would immedi- ment professionals, and administrators. These individuals ately be moved to a separate storage area farther away from can determine how best to notify other parties, including the other. Risk management texts, articles appearing in the the press and external agencies such as federal, state, and literature, and associations such as the American Society local authorities. The organization should seek legal counsel for Healthcare Risk Management (ASHRM) can provide early in the process. Counsel can provide guidance on how detailed guidance. Contact ASHRM by phone at 312-422- to discuss the situation with the patient and family, how to 3980 or go online at http://www.ashrm.org. 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, One recommendation states that organizations maintain it is critical to know exactly what occurred. Preserving the two lists of key people to contact following a sentinel event: evidence is essential to this process. Immediate steps should (1) key individuals within the organization and (2) indi- be taken by staff to secure any biological specimens, medi- viduals outside the organization.5 Both lists should be kept cations, equipment, medical or other records, and any other up-to-date with current telephone numbers and should be material that might be relevant to investigating the failure.3 accessible to managers, supervisors, and members of a crisis In medication-related events, syringes of recently used management team. A sample sentinel event contact list medications and bottles of medications should be preserved appears as Figure 2-8 on page 39. and sequestered. Because such evidence may be discarded as a part of routine operations, such as when empty vials Responding to media queries through organization proto- are thrown into trash cans, staff must obtain and preserve it cols helps avert complications related to patient confiden- promptly. Protocols established by the health care organiza- tiality, legal discovery, and heat-of-the-moment coverage.5 tion should specify the steps to be taken to preserve relevant Organization policies and procedures should reflect noti- evidence following a sentinel event. fication requirements. They should include policies for communication with the patient and family. Event Investigation Organizations must consider documentation and appro- A provider’s communication and disclosure with relevant priate communication and disclosure to relevant parties parties following the occurrence of an event that led to or immediately following the occurrence of a sentinel event. could have led to patient injury is critical. Relevant parties include the following:

37 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.

41 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

• Patients and families affected by the event physician’s honesty and fallibility as a fellow human being. • Colleagues who could provide clarification, support, and One study reports that the risk of litigation nearly doubles the opportunity to learn from the error when patients are not informed by their physicians of • The health care organization’s and individual provider’s moderately serious mistakes.9 Figure 2-9, page 43, pro­ liability insurers vides a checklist for physicians to follow in disclosing a • Appropriate organization staff, including risk managers Communication and Optimal Resolution (CANDOR) or quality assurance representatives event to a patient or his or her family—which could be a • Others who could provide emotional support or sentinel event.10 Please note that these are guidelines about problem-solving help issues to consider, not Joint Commission requirements. Organizations should be aware that the disclosure of an Conferring with other members of the care team following error or event requires individualized handling. They should an adverse event enables the provider to clarify factual involve risk management or legal counsel to help guide details and the proper sequence of what occurred. It can communication with the patient and his or her family. also help identify what needs to be done in response. Survey Process Disclosure In conducting an accreditation survey, Joint Commission Good communication between providers and patients is surveyors seek to evaluate the organization’s compliance instrumental in achieving positive care outcomes. Yet health with the applicable requirements discussed in Chapter 1 care professionals often do not tell patients or families and to score those requirements based on performance about their mistakes. Fear of malpractice litigation and throughout the organization over time (for example, the the myth of perfect performance reinforce poor provider preceding 12 months for a full accreditation survey). Under communication of errors to patients and their families. the sentinel event requirements, accredited organizations There is little doubt that the current malpractice crisis is are expected to identify and respond appropriately to all a deterrent to the openness required for quality improve- sentinel events occurring in the organization or associated ment.6 However, errors not communicated to patients, with services that the organization provides or provides for. 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 Disclosing mistakes to patients and their families is difficult Commission. The intent is to evaluate compliance with the at best. Yet legal and ethical experts generally advise practi- relevant Leadership and Performance Improvement require- tioners to disclose mistakes to patients and their families in ments—that is, how the organization responds to sentinel as open, honest, and forthright a manner as possible. One events when they occur. However, if a surveyor becomes suggestion is that physicians have an ethical duty to disclose aware of a sentinel event while on site, he or she will take errors when the adverse event does one of the following7: the following steps: • Has a perceptible effect on the patient that was not 1. Inform the CEO or the CEO’s designee that the event discussed in advance as a known risk has been identified. • Necessitates a change in the patient’s care 2. Inform the CEO or the CEO’s designee that the event • Potentially poses an important risk to the patient’s will be reported to the Joint Commission Sentinel future health Event Unit for further review and follow up under the • Involves providing a treatment or procedure without the provisions of the Sentinel Event Policy. patient’s consent During the on-site survey, the surveyor(s) will assess the This idea maintains that disclosure of a mistake may foster organization’s compliance with sentinel event–related stan- learning by compelling the physician to acknowledge it dards in the following ways: truthfully and that the physician-patient relationship can be • Review the organization’s process for responding to a enhanced by honesty.8 Disclosing a mistake might even sentinel event. reduce the risk of litigation if the patient appreciates the • Interview the organization’s leaders and staff about

42 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.

44 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

their expectations and responsibilities for identifying, References reporting, and responding to sentinel events. 1. Joint Commission International. Understanding and Preventing • Ask for and review an example of a root cause analysis Sentinel and Adverse Events in Your Health Care Organization. that has been conducted in the past year to assess the Oak Brook, IL: Joint Commission Resources, 2008. adequacy of the organization’s process for responding 2. Croteau RJ. Sentinel events, root cause analysis and the trustee. Trustee. 2003 Mar;56(3):33–34. to a sentinel event. Additional examples may be reviewed if needed to more fully assess the organization’s 3. Perper JA. Life-threatening and fatal therapeutic misadventures. In Bogner MS, editor: Human Error in Medicine. Hillsdale, NJ: understanding of, and ability to conduct, root cause Lawrence Erlbaum Associates, 1994, 27–52. analyses. In selecting an example, the organization may 4. Spath P. Avoid panic by planning for sentinel events. Hosp Peer choose a previous Joint Commission–reviewed root Rev. 1998 Jun;23(6):112–117. cause analysis or a close call to demonstrate its process 5. Keyes C. Responding to an adverse event. Forum. 1997 for responding to a sentinel event. Apr;18(1):2–3. 6. Blumenthal D. Making medical errors into “medical treasures.” Surveyors also review the effectiveness and sustainability JAMA. 1994 Dec 21;272(23):1867–1868. of organization improvements in systems and processes in 7. Cantor MD, et al. Disclosing adverse events to patients. Jt Comm response to sentinel events previously evaluated under The J Qual Patient Saf. 2005 Jan;31(1):5–12. Joint Commission’s Sentinel Event Policy. 8. Wu AW, McPhee SJ. Education and training: Needs and approaches for handling mistakes in medical training. Paper Onward with Root Cause Analysis presented at the Examining Errors in Health Care Conference, Having developed and implemented a sentinel event policy, Rancho Mirage, CA, Oct 13–15, 1996. the organization is now ready to start performing root 9. Witman A, Hardin S. Patients’ responses to physicians’ mistakes. cause analyses and developing corrective action plans. The Forum. 1997 Apr;18(1):4–5. next four chapters describe step-by-step how to perform a 10. Agency for Healthcare Research and Quality, Rockville, MD. root cause analysis and develop, implement, and assess an Accessed Jul 13, 2017. http://www.ahrq.gov/professionals /quality-patient-safety/patient-safety-resources/resources/candor improvement-driven corrective action plan. /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 55STEP 1: Organize a Team responsibilities for each member 55STEP 2: Define the Problem 55STEP 3: Study the Problem • Identify and define the problem to be investigated, including identifying the systems involved STEP 4: Determine What Happened STEP 5: Identify Contributing Process Factors • Learn about the various types of evidence to be STEP 6: Identify Other Contributing Factors collected and how they may be used to illuminate the problem STEP 7: Measure—Collect and Assess Data on Proximate and Underlying Causes STEP 8: Design and Implement Immediate Changes STEP 9: Identify Which Systems Are Involved— Now suppose an organization has experienced a sentinel The Root Causes event or a close call. Staff have informed leadership and, STEP 10: Prune the List of Root Causes in the case of an actual sentinel event, the organization STEP 11: Confirm Root Causes and Consider has completed preliminary response procedures, including Their Interrelationships ensuring patient safety, risk containment, and preservation STEP 12: Explore and Identify Risk-Reduction Strategies of evidence (as described in Chapter 2). The appropriate STEP 13: Formulate Improvement Actions staff members have documented the event and ensured communication with appropriate stakeholders. What STEP 14: Evaluate Proposed Improvement Actions happens next? STEP 15: Design Improvements STEP 16: Ensure Acceptability of the Corrective This chapter explains how to prepare for a root cause Action Plan analysis. It covers strategies for organizing a team, defining STEP 17: Implement the Improvement Plan the problem, and studying the problem. This includes STEP 18: Develop Measures of Effectiveness examining potential situations such as suicide, elopement, and Ensure Their Success treatment delay, and medication error. A description of each STEP 19: Evaluate Implementation of of these sentinel events appears in Sidebar 3-1, page 48. Improvement Efforts Checklists appear throughout the chapter. A fuller discus- STEP 20: Take Additional Action sion of the tools mentioned at each step of the root cause STEP 21: Communicate the Results analysis process is provided in Chapter 7.

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 first step involved in conducting a root cause analysis is the data they have collected to identify obvious to convene a team to assess the sentinel event or potential follow-up questions. sentinel event. After the event occurs, leadership should immediately organize the team involved to prevent the The assembled team and work groups should create a delay of the root cause analysis process. The team should detailed work plan. The work plan must include target collect information from all the relevant parties while the dates for accomplishing specific objectives. Target dates help

Sidebar 3-1 . Sentinel Event Examples

Suicide Several weeks later, the woman calls the physician’s A 20-year-old male patient is admitted for observation office again, noting that she can feel a hard lump in her to the behavioral health care unit of a general hospital. breast and mentioning that it hurts. The physician tells He has a well-documented history of depression. On his her to come into the office right away. Upon review of her second day in the unit, he attends a particularly clamorous record, the physician finds the results and orders another group session. Following the session, between 10:00 a.m. mammogram with needle localization right away. The test and 11:00 a.m., he commits suicide in his bathroom by reveals a change in the size of a nodule from a previous hanging himself with bedding sheets from the shower- mammogram. This result requires an immediate biopsy, head. A registered nurse finds him at 11:05 a.m., calls a which is positive. Subsequent surgery reveals that the code, and starts unsuccessful resuscitation efforts. cancer has metastasized.

Elopement Medication Error Nursing staff in a long term care facility note that an A 60-year-old male patient receiving home care services 80-year-old woman with a history of progressive dementia complains about a headache to his home health nurse is unusually irritable and restless. She is pacing, talking in on each of the nurse’s three visits during a one-week a loud voice, and complaining about a number of issues. period. The man indicates that he is tired of “bothering” his The nurses on duty are unable to appease her or to deter- primary care physician about various symptoms. At the mine the cause of her distress. Staff members frequently conclusion of the third visit, the nurse offers to discuss remind the woman to move away from the exit door. In the the man’s complaint with his primary care physician upon evening, staff members discover that the woman is no return to the agency. longer on the unit nor in the building. The woman left the When the nurse discusses the headache with the man’s facility without warm clothing on during a cold evening with physician, the physician instructs the nurse to call the local subzero temperatures. She is found dead the following pharmacy with the following prescription: “Fioricet Tabs. morning in a wooded area near the facility. Cause of death #30 Sig: 1-2 tabs q 4-6 hours prn headache Refill x3.” In was exposure. error, the nurse telephones the pharmacy and provides the following prescription: “Fiorinal Tabs. #30 Sig: 1-2 tabs Treatment Delay q 4-6 hours prn headache Refill x3.” The man has a long A 60-year-old female patient goes to an ambulatory health history of peptic ulcer disease, which resulted in several care organization to receive her annual physical from her hospitalizations for gastrointestinal bleeding. longtime physician. The physician orders a mammogram, which she schedules for two weeks later. A week after the The man takes the Fiorinal, which contains 325 milligrams mammogram, a nurse in the physician’s office calls the of aspirin per tablet. In contrast, the intended medica- woman and informs her that additional mammogram tion—Fioricet—contains 325 milligrams of acetaminophen views are required but does not convey any sense of per tablet. The man completes the entire first prescription urgency and then files the x-ray reports in the woman’s and 15 tablets of the first refill. At this point, he goes to the medical record rather than in the proper file for tests emergency department with acute abdominal pain, blood requiring follow-up. When the woman calls the physician’s in the stool, and a hemoglobin count of 4.9. He is immedi- office to ascertain whether the repeat mammogram has ately admitted to the intensive care unit. Within hours, he been ordered, another office employee tells the woman needs life support. After several units of blood and a four- not to worry about it if she did not get a call from the week hospital stay, the man recovers and is able to return physician directly. to his home.

48 CHAPTER 3 | Preparing for Root Cause Analysis

guide the analysis process and provide a structured game ongoing purpose, a team generally meets for shorter plan for the team moving forward.1 periods to address a specific issue. After a particular project is completed, the team often disbands—with a sense of Team leaders sometimes may experience difficulty when accomplishment. trying to keep team members focused. A study reported in the Australian Health Review found that team leaders Why Use a Team? can struggle to maintain focus primarily because teams A team approach brings increased creativity, knowledge, lack an understanding of the root cause analysis process. and experience to solving a problem. Just as a patient’s care Another significant challenge for team leaders in the is provided by a team, the analysis of that care should be study was organizing a team within seven days after the carried out by a team that includes representatives of all the incident occurred.2 professional disciplines involved. Multidisciplinary teams distribute leadership and decision making to all levels of an Leaders must lay the groundwork by creating an environ- organization. Teams in health care organizations provide ment conducive to root cause analysis and improvement a powerful way to integrate services across the continuum through team initiatives. Often, leaders need to assure staff of care.3 They also provide successful strategies to effect that the objective of the process is to improve the organiza- systemwide improvement. tion and identify and reduce risks, rather than assign blame for the incident. Staff may experience guilt, remorse, fear, Who Should Work on the Team? and anxiety following the occurrence of a sentinel event. The core of an appropriate team may already exist in the Leaders must address and discuss these emotions at the form of a targeted performance improvement team repre- earliest stages of team formation. Putting staff members at senting relevant disciplines or services. The selection of ease will enable them to contribute to risk reduction. The team members is critical. The team should include staff team will collaborate to recommend changes, and leader- members at all levels closest to the issues involved—those ship will provide the necessary resources (including time to with fundamental knowledge of the particular process do the work). This partnership results in a defined struc- involved. These individuals will likely gain the most from ture and process for moving forward. While developing a improvement initiatives. If the organization has a quality team and selecting team members, ensure that the elements improvement department, it is helpful to include a repre- shown in Checklist 3-1, below, are present in the organiza- sentative from that department who was not directly tion’s leadership. involved with the event to act as a facilitator.

The decision about whether to include the individual(s) Checklist 3-1 . directly involved in the sentinel event can be made by the Essential Elements for organization on a case-by-case basis. For instance, if an a Team Go-Ahead individual is emotionally traumatized by the event, it may make sense to instead invite another person of the same 33Awareness of and support from top leadership discipline with comparable process knowledge to join the 33Leadership commitment to provide necessary resources, including time team. Later, during the action planning stage it may make sense to bring the individual(s) directly involved with the 33An empowered team with authority and responsibility to recommend and implement sentinel event onto the team to make a positive contribu- process changes tion 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 What Is a Team? commitment to performance improvement. While drawing The word team implies a group that is dynamic and up a tentative list of team members, check to ensure working together toward a well-defined goal. In the health that the team includes the individuals highlighted in care environment, a team should be interdisciplinary. Checklist 3-2, page 50. Unlike committees that hold recurring meetings for an

49 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Checklist 3-2 . leadership and areas or functions represented. Realistically, Team Composition the selection of all team members cannot take place until leaders identify the broad aim of the improvement initia- 33Individuals closest to the event or issues involved tives to be generated by the root cause analysis and correc- 4 33Individuals critical to implementation of potential tive action plan. changes 33A leader with a broad knowledge base who is For example, to investigate the root cause of a medical gas respected and credible utility disruption that led to the death of a patient when 33A person with decision-making authority his oxygen supply was inadvertently cut off, the core team 33Individuals with diverse knowledge bases should include individuals from multiple disciplines. These might include physicians, representatives from clinical staff (nursing and/or respiratory therapy), management, Participation administration, and information management; someone Physician participation on performance improvement teams who works primarily with medical gases and the utility varies. Improvement initiatives resulting from root cause management program; and if vendors are a primary part of analyses often address some aspect of clinical care. In such the analysis, someone from the purchasing or contracting cases, medical staff involvement is essential. However, at services department. times physician involvement is not essential (for example, in a situation in which a pharmacy stocked an incorrect The core team investigating several types of events are listed drug in a medication drawer and a nurse administered the in Sidebar 3-2, page 51. drug without noticing the discrepancy). Leaders should consider carefully whether a physician needs to be involved The team should have a leader who is knowledgeable, inter- in the case at hand. Leaders also must understand the ested, and skilled at group consensus building and applying barriers to physician involvement and take steps to over- the tools of root cause analysis. This person guides the team come those barriers. Factors might include skepticism about through the root cause analysis process while encouraging the purpose of root cause analyses and improvement teams, open communication and broad participation. The leader concerns about relevance and effectiveness of teams, and may function as a facilitator or may assign a separate team lack of time and incentive to participate. In cases in which member to play the facilitator role. This individual should physician participation is vital, leaders need to convince be skilled at being objective and moving the team along. It physicians to take part. 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 commu- The leader should also identify ad hoc members who nity member be able to provide a unique perspective and can provide administrative support, additional insight, valuable input? For example, perhaps team members could and resources. invite the town’s retired pharmacist or a former patient who experienced a patient safety event to join the root Ground Rules cause analysis team. If one of the suspected root causes of a At the first team meeting, the leader should establish sentinel event relates to information management, perhaps ground rules that will help the team avoid distractions the team could invite a member of the local chapter of an information management association or organization. TIP

Team composition may need to change as the team moves Core teams limited in size to no more than nine in and out of areas within the organization that affect or individuals tend to perform with greater efficiency. are affected by the issues being analyzed. An organiza- Experts needed at various points can be added tion should allow for and expect this change to happen. as ad hoc team members and attend only the However, the core team members should remain as stable relevant meetings. as possible throughout the process, at least in terms of 50 CHAPTER 3 | 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 individual responsible for performance improve- the following individuals: ment (facilitator of the group) ►► Any staff member, such as a psychiatrist, who was ►► A social service worker attending the patient at the time of the sentinel event and can discuss the specific circumstances ►► A unit activity staff member of the event The core team investigating the treatment delay in an ►► A nurse from the behavioral health care unit ambulatory health care organization might include the following individuals: ►► An occupational therapist, physical therapist, or recre- ation therapist (who has clinical skills and knowledge ►► The director of the ambulatory health care organization but would not necessarily spend much time on the ►► A staff physician behavioral health care unit) ►► 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 asso- performance improvement ciate vice president) who can make changes The core team investigating the medication error in ►► A safety engineer a home care organization might include the following individuals: ►► 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 ►► A nursing supervisor following individuals: ►► 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 procedures, enabling all team members to become ground rules provide a framework that will allow the team familiar with expectations. to function smoothly: • Decision making: The group must decide what kind • Team mission: The leader should establish the group’s of consensus or majority is needed for a decision, mission or focus as one of systems improvement rather recognizing that decisions belong to the entire team. than individual fault finding. • Attendance: Attendance is crucial. Constant late • Sentinel event policy: The leader should provide arrivals and absences can sabotage the team’s efforts. copies of the organization’s sentinel event policy and Set guidelines for attendance.

51 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

• Meeting schedule: For high attendance and steady Checklist 3-3 . progress, the team should agree on a regular time, day, Leadership Techniques for and place for meetings. They should revisit these matters Promoting High-Quality at various times during the team’s life. Group Discussion • Time line: The leader should present a time line at the initial meeting to keep the group on track as it moves 33Use small groups to report ideas. toward its quality improvement goals. 33Offer quiet time for thinking. • Opportunity to speak: By agreeing at the outset to give 33Ask each person to offer an idea before allowing all members an opportunity to contribute and to be comments or second turns at speaking. heard with respect, the team will focus its attention on 33Keep the discussion focused on observations rather the important area of open communication. than opinions, evaluations, or judgments. • Disagreements: The team must agree to disagree. It 33Keep the discussion moving forward within the must acknowledge and accept that members will openly allotted time frame. debate differences in viewpoint. Discussions may 33Pull the group together if the discussion fragments overflow outside the meeting room, but members should into multiple conversations. feel free to say in a meeting what they say in the hallway. 33Encourage input from quiet members. • Assignments: The team should agree to complete 33Seek consensus or group decisions. assignments within the particular time limits so that delayed work from an individual does not delay the group. an honest, objective assessment of what actually happened. • General rules: The team should discuss all other rules Team members from the department where the sentinel that members believe are important. These rules can event occurred might be defensive about the incident and include whether senior management staff can drop in; try, consciously or otherwise, to minimize or cover up the how electronic devices such as cell phones, pagers, and role of their department. Some team members also may try the like should be handled to minimize distraction; what to blame others for the incident in an attempt to deflect the break frequency should be; and so forth. possible criticism away from their coworkers.

See Checklist 3-3 for techniques team leaders or facilitators A group leader must continually encourage team members can use to ensure high-quality group discussion. to talk honestly about the event and provide the details

How Can the Group Leader TIP Facilitate Discussions? The goal of root cause analysis is to look at a sentinel or To create a “no-blame” environment at meetings, patient safety event from many angles. However, teams leaders should do the following: should complete their root cause analysis in a limited ►►Act as a role model by demonstrating a “let’s learn from this” type of response when a mistake amount of time. To expedite a root cause analysis, the is made. team may have to create smaller work groups and coordi- ►►Give an example of a mistake that the leader nate those efforts through detailed work plans and target personally has made to show that everyone dates. For this reason, it is likely more important that a makes errors. team leader have expertise as a process facilitator than be an ►►Provide examples or positive responses to errors expert in any particular clinical area. The goal of a leader is and some of the lessons learned from errors. to track all the “moving parts” of a root cause analysis and ►►Thank staff members for speaking up and collate the team’s findings into a coherent explanation and offering suggestions. corrective action plan. ►►Reward staff members for suggestions that are shown to result in a measurable, positive impact. When starting a root cause analysis, the biggest challenge ►►Communicate directly and frequently. for a group leader often is ensuring that the team provides

52 CHAPTER 3 | Preparing for Root Cause Analysis

necessary for an effective root cause analysis. An initial step the problem clearly, they can save time and effort and for the team is to emphasize and maintain the confidenti- avoid frustration. ality of the team’s work. Some organizations require team members to sign a confidentiality agreement stipulating Often, when using root cause analysis, the team will define that information shared within the team is not transmitted the problem as a single or sentinel event that caused death or disclosed outside of the team’s established communica- or serious injury. However, the team can also use root tion mechanisms.5 cause analysis to address a series of adverse events that do not carry the significance of a sentinel event but do pose a Group leaders also can set the stage for open, honest discus- serious problem to the health care organization when taken sions by being aware of group dynamics and keeping team in aggregate. 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 TIP blaming language, and predetermination of the correct A well-defined problem statement describes what solutions or changes. 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 Whether the root cause analysis addresses a single incident one person or group to dominate the discussion. Group or a series of events, it should clearly define the problem. leaders who establish confidentiality and reinforce the rules of discussion will find that participation will increase over In response to a sentinel event or a patient safety event, the time. Team members will feel reassured that the goal is to team might ask, “What actually happened or what alerted address systems issues and not to blame individuals. the staff to a close call?” Initially the team can identify the problem or event simply: One way the group leader can help team members relax • Surgery was performed on the incorrect site. and feel more comfortable about expressing themselves is • Patient committed suicide by hanging. to start each meeting with an “icebreaker.” An icebreaker is • Patient could have died following overdose of a drug. a tool that helps the group get to know each other and gets • Abductor tried to leave the unit with an infant that did the conversation going at the beginning of the meeting. not belong to him or her.

The icebreaker may be a brief game or puzzle or simply These simple statements focus on what happened or the having each person in turn answer a general, open-ended, outcome, not on why it happened. During later steps in perhaps even whimsical question unrelated to the business the root cause analysis process, the team will focus on the at hand, for example, “What was your favorite food when sequence of events, on the whys, and on causal factors. you were a child?” or “If you could take a free vacation anywhere in the world, where would you go?” A good For close calls or improvement opportunities, the preceding icebreaker sets a positive, inclusive tone for the meeting. problem statements could be restated as follows: Pick one that works for you and your meeting participants. • Surgery was almost performed on the incorrect site. • Patient attempted to commit suicide by hanging. STEP 2: Define the Problem • Patient almost received overdose of a drug. One of the first steps taken by the root cause analysis team • Abductor was discovered by a nurse before leaving is to define the problem—that is, to describe, as accurately the unit. as possible, what happened or what nearly happened. The purpose of defining the problem as clearly and specifi- Particularly in the event of a close call, multiple causal cally as possible is to help focus the team’s analysis and factors may exist. Each team needs to develop ranking improvement efforts. If the team defines and understands criteria to decide which factor to address first. One option

53 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

is to rank causal factors by their cost impact, organization For example, analysis teams frequently cite medication priority, consequence or severity, safety impact, or real or ordering as a risk-prone system due to organization hierar- potential hazard.6 Causal factors should be addressed one chies. Nurses and pharmacists may be reluctant to question at a time. The team should tackle the highest-ranked factor physicians writing the orders. Some organization cultures and solve it before initiating work on lower-ranked factors. may create a hierarchical rather than team structure for (Chapter 6 will provide more information on this idea.) the entire medication use process. Similarly, verification of surgical sites by surgical team members can suffer from Help with Problem Definition hierarchical pressures. Nurses may be reluctant to question The information disseminated from the Sentinel Event physicians. The hierarchical mind-set can affect everyday Database of The Joint Commission can help an organiza- scenarios as well, as in a situation in which a housekeeper tion identify a problem or area for analysis. The purpose of hesitates to question a respiratory therapist observed this database is to increase general knowledge about sentinel touching patients without first performing hand hygiene. events, their causes, and strategies for prevention. The Joint Language barriers coupled with a hierarchical culture can Commission collects and analyzes data from the review present a particularly problematic scenario. of actual sentinel events, root cause analyses, corrective action plans, and follow-up activities in all types of health Identify High-Risk Processes care organizations. The goal of sharing lessons learned Most frequently, sentinel events result from multiple system with other health care organizations is to reduce the risk of failures. They also frequently occur at the point at which future sentinel events. one system overlaps or hands off to another. An organiza- tion should be tracking high-risk, high-volume, and prob- Organizations can learn about sentinel events that occur lem-prone processes as part of its performance improve- with significant frequency, their root causes, and possible ment efforts. High-risk, high-volume, problem-prone areas risk-reduction strategies through The Joint Commission’s vary by organization and are integrally related to the care, publication Sentinel Event Alert (see Sidebar 3-3, page 55) treatment, and services provided. For example, to reduce and the official newsletter The Joint Commission Perspectives® the risk of infant abductions, a large maternity unit should received by every accredited organization. Sentinel events focus on its infant-parent identification process. To reduce reported in the national media, such as the medication the risk of patient suicide, a behavioral health care unit error described in the Introduction, can also serve as a should focus on its process for suicide risk assessment. source of ideas for problem analysis. All organizations can use the areas or problems outlined here as a starting point A first step to finding such processes includes the list of in identifying a problem area for analysis. frequently occurring sentinel events published by The Joint Commission; an organization’s risk management Identify Complex Systems data, morbidity and mortality data, and performance data Identifying problem areas such as failure-prone systems (including sentinel event indicators and aggregate data through root cause analysis requires focus. A number indicators); and information about problematic processes of factors increase the risk of system failures, including generated by field-specific or professional organizations. complexity—a high number of steps and handoffs in work processes. Complex systems may be dynamic, with constant Developing a Preliminary Work Plan and change and tight time pressure and constraints. The tight Reporting Mechanism coupling of process steps can increase the risk of failure. After a team has defined the problem, it can develop a Tightly coupled systems or processes do not provide much preliminary work plan for investigating the sentinel event slack or the opportunity for recovery. Sequences do not through root cause analysis. The plan should outline the vary, and delays in one step throw off the entire process. overall strategy, key steps, individuals responsible for each Variable input and nonstandardized process steps can step, target dates, and reporting mechanisms. It is essen- increase the risk of process failure. So can processes carried tial at this point to define the scope of the plan so team out in a hierarchical rather than team structure. members can provide a specific answer to the question, “How will we know if we are successful?”

54 CHAPTER 3 | 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 ►► Safe use of health information technology (Mar 2015) awareness (Oct 2004)

►► 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 ►► Health care worker fatigue and patient safety (Feb 2002) (Dec 2011) ►► Prevention of wrong-site surgery (Dec 2001, Aug 1998) ►► Radiation risks of diagnostic imaging (Sep 2011) ►► Medication errors related to potentially dangerous ►► A follow-up report on preventing suicide: Focus on abbreviations (Sep 2001) medical/surgical units and the emergency department ►► Preventing needlestick and sharps injuries (Aug 2001) (Nov 2010) ►► 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 ►► Preventing adverse events caused by emergency .jointcommission.org/sentinel_event.aspx. electrical power system failures (Sep 2006)

55 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Creating a detailed work plan is critical to the process and Frequency of communication also varies according to will secure management support. The full work plan should the actions required in the short term to prevent recur- include target dates for major milestones and key activities rence of the event. The team needs to weigh communica- in the root cause analysis process. These dates can mirror tion frequency against the speed with which information the steps of the root cause analysis and corrective action emerges from the investigation. If information merges plan itself, including the following tasks: rapidly, the team leader should identify the most produc- • Defining the event and identifying the proximate and tive timing for communication. A description of reporting underlying causes considerations for each of the sample root cause analysis • Collecting and assessing data about proximate and investigations follows. underlying causes • Designing and implementing immediate changes The reporting mechanism for a suicide investigation should • Identifying the root causes ensure that the psychiatrist on the team provides his or • Planning improvement her colleagues with regular updates on the team’s progress • Testing, implementing, and measuring the success at clinical department meetings. Such updates prepare the of improvements medical staff for recommended policy changes. Similarly, at executive staff meetings, the vice president on the team For a sentinel event that meets the sentinel event definition should provide the CEO, chief operating officer, and of The Joint Commission or Joint Commission other leaders with regular updates on the team’s progress. International, the root cause analysis must be completed Frequent communication will foster leadership acceptance within 45 days of the sentinel event or becoming aware of future recommendations, particularly those involving of the event. significant resources. Safety should appear as a standing agenda item at board meetings as well. Figure 3-1, page 57, indicates the key steps to include in a work plan for a root cause analysis and provides space to The reporting mechanism for the elopement investigation track the milestones. Later chapters describe each activity in should ensure that the safety director provides the facility more detail. management and operations staff with regular updates on the team’s progress. Such updates prepare the staff for any A team’s outline of the reporting mechanism aims to ensure recommended building alterations to enhance the safety of that the right people receive the right information at the the care environment. right time. At the beginning of the process, the team leader or facilitator should establish a means of communicating The reporting mechanism for the treatment delay investi- team progress and findings to senior leadership. Keeping gation in an ambulatory health care organization should senior leaders informed on a regular basis is critical to ensure that the office manager keeps the physician or management support of the root cause analysis initiative medical director informed of the team’s progress on a and implementation of its recommendations. Although it is regular basis. This regular communication prepares the difficult to provide guidelines on how a regular basis should medical director for any possible changes with respect to be defined because the time frame varies widely depending staffing levels and staff orientation, training, and ongoing on circumstances, communication with senior leaders competence assessment. should increase in frequency with the following: • Serious adverse outcomes The reporting mechanism for the medication error inves- • Repeated patient safety events tigation should ensure that the information technology • Events requiring solutions from multiple parts of staff member keeps his or her colleagues informed of the the organization team’s progress. This information flow facilitates the smooth • Possible solutions requiring the investment of significant integration of any new processes or technology that may amounts of money enhance safe medication ordering. • Media involvement in the case and its solutions

56 CHAPTER 3 | Preparing for Root Cause Analysis

Figure 3-1 . Tracking Key Steps in Root Cause Analysis DOWNLOAD

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.

57 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 The team is now ready to start studying the problem. Doing information. Some methods are more suitable than others. so involves collecting information surrounding the event For example, audio recording or video recording an inter- or close calls. Time is of the essence because key facts can view with someone closely involved with the event will be forgotten in a matter of days. The individual(s) closest likely increase an individual’s defensiveness. Note taking is to the event or close call may have already collected some a more effective and less threatening way to record inter- information that the team can use as a starting point. Often views. Video recordings, drawings, and/or photographs are a written statement provided by individuals involved in the effective media to record physical evidence. For instance, if event and prepared as near the time of the event as possible an organization experiences an accidental death in which an can be useful throughout the root cause analysis process. At individual served is strangled after slipping through guard times, the individual(s) closest to the event may withhold rails on a bed, a video image or photo of the bed with guard critical information due to fear of blame. The team should rails in place provides evidence of the position of the bed consider how to minimize such fear (see Sidebar 3-4, which following the event. The team should not rely on anyone’s provides sample statements for enhancing comfort). It memory. Instead, a collection of notes, audio recordings, may be necessary in some instances to obtain an individu- video recordings, photographs, and drawings ensures accu- al’s written statement and then proceed without his or her racy and thoroughness of information. Drawings can be contribution in the early stages of the analysis. particularly helpful for events such as patient falls, in which the team wants to get a sense of the layout of the room

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.” your coworkers did during this event because your (Emphasizes learning from the event, not blaming or individual responses to the situation are not the thing punishing anyone.) that matters to us. It’s the overall process that we are looking at.” (States that the goal of the inquiry is ►► “Last year, when nurses shared details on their medi- to look at organizational processes, not at individual cation administration practices, we found three areas behaviors.) in which we could make process improvements. As a result, our drug error rates dropped significantly.” ►► “Everyone has an opinion, and we truly value yours. (Provides examples of mistakes made in the past, how We realize that in our hectic day-to-day work lives, you the organization learned from the mistakes, and how don’t always get a chance to share opinions. Well, here patients benefited from the subsequent improvements.) is your chance: Tell us what needs to be changed.” (Asks for suggestions on how processes can be ►► “Please go ahead and talk freely about the incident. changed.) We’re not interested in assigning blame, we’re only interested in helping patients. Isn’t that really why we’re ►► “You are the real expert. You’re on the front line, so all here in the first place?” (Encourages staff members you know what really goes on when you are delivering to speak freely without fear of retribution from manage- care. We’re trying to understand everything you go ment or peers.) through, so we truly want you to share your exper- tise.” (Reinforces the idea that frontline staff are the ►► “We want to gather insight into what works and what only true process experts—they have the best knowl- doesn’t work with our current processes. Therefore, edge and vantage point to help come up with effective we are offering a $25 bookstore gift card to anyone improvements.) who can point to a process that needs improvement.” (Rewards staff members for providing insight into the event.)

58 CHAPTER 3 | Preparing for Root Cause Analysis

where a fall occurred. These various methods of recording are not—that is, those that are or are not capable of information can all benefit the team’s progress. breaking automatically in response to a predetermined external force (for example, the weight of an individual). TIP • Information to be collected in an elopement investigation might include an environment of care The following media can be used to record inventory of unattended or unmonitored exits; information obtained during a root cause analysis: availability and functionality of wander-prevention ►►Written or typed notes technology such as electric bracelets and wired exits; ►►Photographs or drawings data related to the thoroughness and frequency of ►►Audio recording initial resident assessment and ongoing reassessment for ►►Video recording elopement risk; and information regarding how data It is important that the team obtain legal counsel about individuals at risk for elopement are integrated on how to protect the organization from being into initial and ongoing care plans. required to disclose the information in a potential • Information to be collected in a treatment delay lawsuit as well as the requirements for consent to investigation might include data about how test results tape or film individuals. The facilitator should collect are processed within the organization and how staff all notes and materials to keep in the root cause members are trained in these processes initially and on a analysis file to maintain existing protections from continuing basis. Data related to competence assessment legal discovery. testing and staffing levels would also be valuable. • Information to be collected in a medication error In all cases, the team should seek guidance from the investigation might include data on how medication organization’s legal counsel regarding protection of informa- orders are transmitted to local pharmacies and the tion from discovery through its inclusion in peer review percentage of queries and errors due to illegible and other means. The team also should seek guidance physician handwriting, misinterpretation of physician from the organization’s risk management department or handwriting, telephone or verbal orders, and order legal counsel along with representatives of the health transcription. Data related to the frequency of nurse information management department concerning patient communication about a new medication and patient confidentiality and the information collected during the education efforts would also be valuable. root cause analysis. Although information or data collection occurs throughout Collecting a huge amount of data, much of it unrelated the root cause analysis process, the team may also want to in any way, can be unproductive and confusing. To focus gather three key types of information at this early stage6: collection efforts, examine the problem statement and collect data along potential lines of inquiry. The list of 1. Witness statements and observations from those questions in Sidebar 3-5, page 60, can provide guidance closest to the event or close call as well as those for potential lines of inquiry. For example, if a problem indirectly involved statement such as “Patient was given wrong medication” 2. Physical evidence related to the event or close call suggests an equipment maintenance or human resources 3. Documentary evidence problem, then collect data relevant to medication distribu- tion systems, training, and so forth. A sampling of infor- The following sections will address each type of mation that might be collected relevant to the suicide, information further. elopement, treatment delay, and medication error examples described back in Sidebar 3-1, page 48, follows: Witness Statements and Observations • Information to be collected in a suicide investigation Interviews with staff members can provide a wealth of might include an environment of care inventory of all information during a number of stages of root cause fixtures in the behavioral health care units and data analysis. Shortly after an event or close call, interviews with on which fixtures are breakaway compliant and which staff members directly involved can probe for what

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Sidebar 3-5 . from each person, without the influence of others in the Types of Open-Ended Questions room. However, additional group interviews afterward can encourage greater interplay of ideas and reinforcement of Open-ended questions ensure that the interviewee the process improvement message. provides more than a simple “yes” or “no” answer. Three types of open-ended questions that can be used Conducting interviews is both an art and a science. Some effectively to gain the depth and breadth of information people do it well; some do not. The team should carefully needed during interviews follow. consider who is best suited to interview each subject and the best possible timing and sequence of interviews to be Exploratory Questions conducted. The goal of the interviews is to identify facts, Exploratory questions can be used effectively to begin possible systemic causes, and improvement opportunities— the discussion or move to a new topic. They encourage not to place blame. The team should identify all likely the interviewee to provide both comprehensive and interview candidates at each stage and be aware that people in-depth information. Examples include the following: tend to forget information or remember it incorrectly, ►► “What can you tell me about . . . ?” rationalize situations, and perceive situations differently. ►► “What can you recall about . . . ?” Four discrete stages of continuous interview process Follow-Up Questions are preparing for the interview, opening the interview, Often, it may be necessary to clarify or amplify informa- conducting the interview, and closing the interview. tion provided by the interviewee. Follow-up questions Consider the following descriptions7: 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 ►► “What is . . . ?” carefully worded interview questions that are open-ended. ►► “How did this come about?” Planning also includes scheduling the interview, deter- mining how information will be recorded and documented, Comment Questions preparing to answer questions that the interviewee is likely Comment questions (or statements) encourage elabo- to ask, identifying material that should be available as a ration and express interest while not sounding so much like a question. Examples include the following: reference during the interview, and establishing the physical setting. Carefully worded responses to such questions ►► “Could you please describe that further?” as “Why do you want to talk with me?” and “What will ►► “I would like to know more about that.” you do with the information I provide?” can go a long way toward reducing the interviewee’s defensiveness, Source: Adapted from Minnesota Department of Public Health. Root and so can a neutral setting that ensures privacy and Cause Analysis Toolkit. Apr 7, 2014. Accessed Mar 4, 2017. http://www .health.state.mn.us/patientsafety/toolkit/. discourages interruptions.

Opening the Interview happened or almost happened and why (proximate causes). The interviewer should greet the interviewee, exchange Interviews with staff members indirectly involved can informal pleasantries, state the purpose of the interview, explore possible root causes. Later in the process, interviews and answer the interviewee’s questions. The goal is to can provide insight into possible improvement initiatives establish rapport, put the interviewee at ease, establish and implementation strategies. The team should try to credibility, and get the interviewee involved in the inter- strike a balance between individual interviews and group view process as quickly as possible. The interviewer should interviews. Individual interviews are important for indicate at this stage the amount of time the interview is obtaining as accurate an account of the situation as possible expected to take.

60 CHAPTER 3 | Preparing for Root Cause Analysis

Conducting the Interview analysis process and do not reflect any suspicion of the The interviewer poses the open-ended questions developed information provided in initial interviews. during the preparation stage. Open-ended questions elicit • Interviewees should be encouraged to contact the team information by encouraging more than a “yes” or “no” leader with any concerns or additional information. response. Refer back to Sidebar 3-5 for examples of ways to pose such questions and for examples of question types that Group interviews can be more efficient than individual can help ensure the questions sound natural. interviews, but the interviewer also should consider and weigh with care any disadvantages. Disadvantages include A two-step probing technique, using an open-ended dominance by more vocal members of the group and exploratory question and then a follow-up question asking the emergence of groupthink, which can stifle individual “why,” can yield valuable information. For example, the accounts of an event. interviewer might first ask, “What can you tell me about the administration of medication in the unit?” After the When in-person interviews are not possible, telephone interviewee responds, the interviewer might follow up interviews can provide an alternative. However, the tele- with, “Why do you think that is the case?” This technique phone has some serious limitations. It is much more diffi- should be used judiciously and reserved for important cult to establish and maintain rapport when eye contact is areas because its repetition could make the interviewee not part of the interview, and, of course, nonverbal cues are feel “drilled.” much harder to detect.

Throughout the interview, the interviewer should listen Written responses from an observer to specific questions well, avoid interrupting the interviewee, avoid talking exces- raised by the team offer another alternative. However, this sively, ask purposeful questions, and summarize throughout method is less likely than either in-person or telephone the interview to confirm a proper understanding of what interviews to elicit in-depth information. A matter as the interviewee relates. The interviewer should also be aware seemingly trivial as how much space is provided for answers of his or her own body language, as well as of the interview- on the form can have a significant impact on the quantity ee’s body language and other nonverbal cues. of information provided. In addition, when the observer must put something in writing, his or her concern about Closing the Interview the privacy and confidentiality of the information may The interviewer should check to ensure that he or she has increase defensive behavior, thereby preventing full disclo- obtained all necessary information; ask the interviewee if sure and honesty. he or she has any questions or concerns; summarize the complete interview to ensure that the information accu- rately reflects the interviewee’s words; and thank the inter- TIP viewee, expressing appreciation for his or her time, honesty, and assistance. Overcome interviewee defensiveness by doing the following: ►►Restate the focus and purpose of the interview After the interviewee leaves the interview area, the inter- and reiterate that information obtained will be viewer should document any further observations and iden- used to help prevent future occurrences of an tify follow-up items. The interviewer should communicate adverse event rather than to assign blame. conclusions and results to the root cause analysis team as ►►Send positive, supportive messages through appropriate. statements such as “What you have said is so helpful” and “I understand, and you have Remember the following points when gathering informa- obviously given this a lot of good thought.” tion from caregivers8: ►►Gently ask about a defensive reaction and probe • The way questions are asked will affect people’s why the interviewee feels threatened. (Take great memories and their willingness to help. care here to ensure that this inquiry will not do • Interviewers should inform interviewees that follow- more harm than good.) up interviews are a normal part of the root cause 61 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Physical Evidence All such evidence should be examined, secured, and labeled Interviews with personnel closest to the event can help appropriately by the team. the team identify relevant physical evidence, including equipment, materials, and devices. Preserving physical Documentary evidence varies considerably, based on the evidence immediately following the event or close call can actual sentinel event or possible sentinel event. Examples of be essential to understanding why an event occurred or documentary evidence for various error types are shown in almost occurred. In many instances, individuals may take, Sidebar 3-6. This information is a starting place in consid- misplace, destroy, move, or alter physical evidence in some ering the kind of documentary evidence needed for any way, inadvertently or even deliberately. organization’s root cause analysis.

Physical evidence for a sentinel event involving a medication Literature Review error, for example, might include the drug vial, syringe, At this point and throughout the root cause analysis, a thor- prescription, IV drip, filter straws, and medication storage ough review of the professional literature is an important area. Physical evidence for a suicide in a 24-hour care setting component of the process. Literature searches can yield might include breakaway bars and fixtures in the shower or helpful information about the event at hand and other elsewhere, a window, a ceiling, and other sites. Physical organizations’ experiences with a similar event. The litera- evidence for a wrong-site surgery might include the x-rays, ture can help identify possible root causes and improvement the operative arena, surgical instruments, and so forth. strategies. Appropriate professional or industry associations and societies can provide a good starting point in the review The evidence should be thoroughly inspected by a knowl- process. The team can obtain a variety of information on edgeable team member, ad hoc member, or consultant. the subject. A review of other organizations’ practices and Perhaps equipment was not fully assembled or parts were experiences can help the team avoid mistakes and inspire missing. Team members should document observations creative thinking. To investigate causes and improvement from the inspection. They should label all physical evidence strategies for the sample sentinel events shown previously in with information on the source, location, date and time Sidebar 3-1, page 48, team members might obtain informa- collected, basic content, and name of the individual tion such as the below possibilities. collecting it and then secure it in a separate area, if feasible. If not, such as with a large piece of equipment, team For a suicide event, the team might obtain policies, members should tag the item to indicate that it failed and procedures, and forms for suicide risk assessment from that its use is prohibited, pending investigation results. other organizations. A team member might conduct an online literature search to obtain protocols for suicide risk Documentary Evidence ­assessment from relevant professional journals. Documentary evidence includes all material in paper or electronic format that is relevant to the event or close call. It For an elopement event, the team might obtain resident could include the following: assessment policies, procedures, and forms from other long • Patient records, physician orders, medication profiles, term care organizations and specifically information related laboratory test results, and all other documents used to to how they assess at-risk-for-elopement status. The facility record patient status and care or safety manager might obtain information from other • Policies and procedures, correspondence, and meeting organizations related to systems used to ensure appropriate minutes security in the environment of care, such as wander- • Human resources–related documents such as prevention technology. Assessment protocols from relevant performance evaluations, competence assessments, and professional journals might be helpful as well. physician profiles • Indicator data used to measure performance For a treatment delay event, the team might obtain policies, • Maintenance information such as work orders, procedures, and protocols for communicating abnormal equipment logs, instructions for use, vendor manuals, test findings from the professional literature and peer and testing and inspection records ambulatory health care organizations. Training and

62 CHAPTER 3 | 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) ►► Procedures for medication allergy interaction checking or to the local, regional, or national agency (for Joint ►► Pharmacy lot number logs Commission International customers)

►► 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 ►► Inspection, performance measurement, and testing poli- assessment programs in utilities systems processes 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 competence assessment literature could also provide insight References for improvement strategies. Professional organizations 1. Joint Commission International. Understanding and Preventing might be a source of information on criteria for calling Sentinel and Adverse Events in Your Health Care Organization. in additional specialists. 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 For a medication error event, the team might contact other Health Rev. 2005 Nov;29(4):422–428. home care organizations to obtain information about the 3. Ogrinc GS, et al. Fundamentals of Health Care Improvement: A policies and protocols used to ensure a safe medication use Guide to Improving Your Patients’ Care, 2nd ed. Oak Brook, IL: process. An online literature review could provide improve- Joint Commission Resources, 2012. ment strategies recommended by other health care organi- 4. Shaqdan K, et al. Root-cause analysis and health failure mode zations following a sentinel event or close call. and effect analysis: Two leading techniques in health care quality assessment. J Am Coll Radiol. 2014 Jun;11(6):572–579.

63 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

5. Hoffman C, et al. Canadian Root Cause Analysis Framework: 7. Minnesota Department of Health. Root Cause Analysis Toolkit. A Tool for Identifying and Addressing the Root Causes of Critical Accessed July 14, 2017. http://www.health.state.mn.us Incidents in Healthcare. Edmonton, AB: Canadian Patient Safety /patientsafety/toolkit/. Institute, 2006. 8. Boyd M. A method for prioritizing interventions following root 6. Andersen B, Fagerhaug T, Beltz M. Root Cause Analysis and cause analysis (RCA): Lessons from philosophy. J Eval Clin Pract. Improvement in the Healthcare Sector: A Step-by-Step Guide. 2015 Jun;21(3):461–469. Milwaukee: ASQ Quality Press, 2010.

64 CHAPTER 4

Determining Proximate Causes

Learning Objectives Root Cause Analysis: Step-by-Step • Learn to identify contributing process factors STEP 1: Organize a Team • Identify what needs to be measured and learn to STEP 2: Define the Problem apply a variety of effective measurements STEP 3: Study the Problem • Explore the tools with which a team can search for 55STEP 4: Determine What Happened proximate or direct causes 55STEP 5: Identify Contributing Process Factors 55STEP 6: Identify Other Contributing Factors 55STEP 7: Measure—Collect and Assess Data Tools to Use on Proximate and Underlying Causes 55STEP 8: Design and Implement Immediate Changes The following tools will help a team determine STEP 9:  proximate causes: Identify Which Systems Are Involved— The Root Causes ►► Affinity diagram (see Figure 7-1, page 114) STEP 10: Prune the List of Root Causes ►► Brainstorming (see Figure 7-2, page 115) STEP 11: Confirm Root Causes and Consider ►► Change analysis (see Figure 7-3, page 116) Their Interrelationships ►► Fishbone diagram (see Figure 7-8, page 124) STEP 12: Explore and Identify Risk-Reduction Strategies ►► Flowchart (see Figure 7-9, page 126) STEP 13: Formulate Improvement Actions ►► Gantt chart (see Figure 7-10, page 127) STEP 14: Evaluate Proposed Improvement Actions STEP 15: Design Improvements STEP 16: Ensure Acceptability of the Corrective Prior to this point in the process, the team has created a Action Plan very simple, one-sentence definition of what happened or STEP 17: Implement the Improvement Plan could have happened and has begun studying the problem. STEP 18: Develop Measures of Effectiveness The next step involves creating a more detailed description and Ensure Their Success or definition of the event (see the Appendix for a sample STEP 19: Evaluate Implementation of event description form). Improvement Efforts STEP 20: Take Additional Action STEP 21: 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.

65 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

The Joint Commission’s Framework for Root Cause piece of information appears on the tool so the source can Analysis and Action Plan provides an example of be consulted if more information is needed. a comprehensive systematic analysis. Please see the Appendix for the framework and its 24 analysis In creating this more detailed definition of an event, team questions. These questions are intended to provide a members should stick to the known facts and not speculate, template for analyzing an event and an aid in organizing prior to completing the root cause analysis, on what is not the steps and information in a root cause analysis. 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, STEP 4: Determine What Happened lying on floor, dead. Sentinel event occurred sometime This description provides the when, where, and how details between 0200 and 0330, Thursday, March 4.” Did of the event. It should include a brief description of the patient die because of a fall? Or did the patient the following: fall after or while dying? A root cause analysis will help • What happened? the team identify the cause of death. In this example, • Where and when did the event occur (place, date, day of relevant areas or services affected by the event might week, and time)? include nursing (to investigate monitoring systems and • What areas or services were affected? medication administration), biomedical (to investigate the type of bed, alarm, and call light system), staffing For example, with a sentinel event involving a medication office (to investigate whether the type of staff—regular error, a more detailed definition of the event might state, or float—affected the event), education (to investigate orientation and training provided to staff and patient), “A 60-year-old man receiving home care services pharmacy (to investigate patient medications), medical complains about a headache to his home health nurse staff protocols (to investigate medications ordered on each of the nurse’s three visits during a one-week for the patient), and policies and procedures (related period. The man indicates that he is tired of bothering to fall risk assessment, interventions, patient education, his primary care physician about various symptoms. and so on).

At the conclusion of the third visit, the nurse offers STEP 5: Identify Contributing to discuss the man’s complaint with his primary care Process Factors physician upon return to the agency. The discussion Root cause analysis involves repeatedly asking “Why?” to results in the physician prescribing a medication. A identify the underlying root causes of an event or possible transcription error results in the patient receiving event. At this point, the team asks the first of a series of Fiorinal, instead of Fioricet, which results in gastroin- “why” questions. The goal of the first “why” question is to testinal bleeding, a trip to the emergency department, identify the proximate causes of the event. Proximate causes, and a four-week hospital stay. The prescription was or direct causes, are the most apparent or immediate reasons delivered on Friday, January 1, and the patient was for an event. They involve factors closest to the origin of admitted to the hospital on Monday, January 4.” an event, and they can generally be determined by asking, “Why did the event happen?” (See Sidebar 4-1 for more on The relevant areas for this sentinel event might be nursing, asking “why?”) medicine, home care, and pharmacy. In most cases, identifying the proximate causes is simple; in Developing a flowchart is often helpful to determine the other cases, it might take some digging. For example, in the sequence of events. Such a tool can help the team retain case of the patient found dead by her bed, proximate causes focus on seeking the facts of the event (see Figure 7-9, page could include “failure to monitor patient,” “bed alarm not 126, for a sample flowchart). Ensure that the source of each working,” “call light not working,” “patient not properly

66 CHAPTER 4 | Determining Proximate Causes

Sidebar 4-1 . 2. What are the steps and linkages between the steps in the The Five Whys process (a) as designed, (b) as routinely performed, and (c) as occurred with the sentinel event? The Five Whys is a problem-solving technique that 3. Which steps and linkages were involved in, or helps users to get to the root cause of the problem contributed to, the event? quickly without statistical analysis. Users commonly apply this strategy at the beginning of a process The team can use a variety of tools to attain a thorough improvement project. However, it can be used at any response to these questions. A flowchart is a useful way to time to understand the root cause of any problem. visualize the response to the questions “What are the steps It’s about asking the question “Why?” five times. Instead in the process?” and “What actually happens?” The team of stopping at the symptom, users drill down to the can use brainstorming to identify processes and to confirm underlying cause. This technique focuses on finding the that all relevant steps are included in the list of process vital root cause that is affecting the overall problem. steps. Change analysis (see Figure 7-3, page 116) and ►► Begin with your team’s problem statement. Frame the statement as a question. Fishbone diagrams (see Figure 7-8, page 124) are useful techniques in analyzing a response to the question Why was the medication dosage for “Which steps and linkages were involved in or contributed Patient X missed? to the event?” ►► As a project team, ask the question “Why?” Reach consensus on the answer the team would like to The team can then probe further by asking three start with. Write that answer down on a Post-It Note more questions: or whiteboard. 1. What is currently done to prevent failure at this step or Because Dr. Y was on the floor looking for an its link with the next step? update on Patient Z 2. What is currently done to protect against a bad outcome ►► Ask “Why?” for a second time. Come up with an if there is failure at this step or linkage? answer. Reach consensus and write the next answer 3. What other areas or services are affected? down. Why was Dr Y on the floor? Because he had Comparing the flowchart of the process as specified in surgeries scheduled in the morning. written policies and procedures to the flowcharts of the process as routinely performed can alert the team to staff ►► Continue asking “Why?” and documenting each answer until the root cause to the original problem actions that circumvent policies and procedure (knowingly has been identified. or unknowingly). Staff members who perform the processes in question should routinely compare their actual actions This process may require asking the question “Why?” to the prescribed policies and procedures to detect any more than five times. discrepancies. oriented to use of call light,” “incorrect sedation dispensed,” STEP 6: Identify Other Contributing or “incorrect administration of sedation.” Factors In health care environments, proximate causes tend to fall Underlying causes in the health care environment may relate into a number of distinct categories beyond and in addition to the provision of care or to other processes. Hence, iden- to process factors. They include the following: tification of the patient care processes or activities involved • Human factors in the sentinel event or potential sentinel event will help the • Equipment factors team identify contributing causes. At this point, asking and • Information-related factors answering the following three questions will assist the team: • Controllable or uncontrollable environmental factors 1. Which processes were involved in the sentinel event or close call?

67 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

To identify additional proximate causes of an event Identifying the proximate causes of a patient suicide, as involving human factors, the team might ask: described in Chapter 3, might lead a team to conclude • What human factors contributed to the outcome? the following: • What information-related factors impacted the outcome? • Human factors such as failure to follow policies on • What factors directly affected the outcome? precaution orders or failure to conduct appropriate staff • Were such factors within or truly beyond the education or training organization’s control?” • Assessment process factors such as a faulty initial assessment process that did not include identification of Finally, the team might ask, “Are there any other factors a history of suicide attempts or an immediate psychiatric that have directly influenced this outcome?” Table 4-1, consultation on page 69, identifies many of the common factors associ- • Process or human factors such as a faulty history and ated with failures related to equipment, environment, physical assessment that did not identify patient suicide information, staff/people, and others. risk factors • Equipment factors such as a nonfunctional paging Communication-related errors often result in procedure- system that delayed communication with the related failures. The majority of these errors involve four patient’s physician types of communication: 1. Communication of relevant patient information among Brainstorming to identify all possible or potential contrib- staff members uting causes may be a useful technique for teams at this 2. Communication between physicians and other stage of the root cause analysis (see Figure 7-2, page 115, physicians or staff members for a sample list of contributing factors, developed during a 3. Communication between staff and the patient or family brainstorming session). Following traditional brainstorming 4. Oral communication problems, such as incomplete ground rules—such as not labeling anything a bad idea and change-of-shift reports; problems with administration, ensuring that team members do not express reactions or such as delayed reporting of hazardous conditions; and provide commentary as ideas are expressed—is critical to electronic communication problems success. The focus must be on improving patient outcomes rather than individual performance. The team can use Two other common factors in procedure-related failures are affinity diagrams to help sort or organize the causes or flawed processes and failure to follow a defined process. It is potential causes into natural, related groupings (see Figure important to distinguish between the two when analyzing 7-1, page 114). root causes and developing improvement actions. While asking questions to uncover causes, the team leader A flawed process is a process that can become a root cause should keep team members focused on processes, not of errors, even when people are following the process people. One individual’s actions generally will not be a root correctly. When the team identifies a flawed process as the cause. The team must focus on the systems within which cause of an error, they must analyze and change the process people are operating. That is the level at which they will to eliminate the possibility of more errors. find most root causes. By repeatedly asking “Why?” the team can continue working until it feels it has exhausted Failure to follow a defined process occurs when staff all possible questions and causes. The importance of this members fail to follow an established process and cause an stage cannot be overstated. It provides the initial substance error. When the team identifies failure to follow a defined for the root cause analysis without which a team process as a factor, they must hold an inquiry as to why the cannot proceed. process wasn’t followed: Is it a bad policy or is it that staff members are not informed about the policy? Does the After sorting and analyzing the cause list, the team may organization tolerate shortcuts? start to determine which process or system each cause is a part of and whether the cause is a special or common

68 CHAPTER 4 | Determining Proximate Causes

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 • Equipment, device, or product supplies problems or availability IT factors • 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 • 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 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 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 Measurement is the process of collecting and aggregating fully in the next chapter, helps unearth systems-based root data. The process helps assess the level of performance, causes. Table 4-1 lists categories or types of root causes and determine whether improvement actions are necessary, and provides examples of causal factors within the categories ascertain whether improvement has occurred. that lead to process and system breakdowns. The team must begin gathering data as soon as possible STEP 7: Measure—Collect and Assess after the event occurs to prevent loss or alteration of the Data on Proximate and Underlying Causes data. Data from people are the most easily altered or To get to the heart of uncovering root causes, the team destroyed and need to be made a priority. Other forms must explore in depth proximate and underlying causes. of data are more stable; however, the team needs to iden- This exploration involves measurement—collecting and tify physical data quickly to prevent inadvertent loss assessing relevant data. Although this exploration is or destruction. presented here as step 7, data collection and analysis initia- tives may occur throughout root cause analysis and need Purposes of Measurement not be sequential or follow step 6 and precede step 8. Organizations collect data to monitor the stability of existing processes, identify opportunities for improvement,

69 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

identify changes that lead to improvement, and Sidebar 4-2 . maintain changes. Determining What to Measure

Baseline Data When choosing what to measure, an organization The first purpose of measurement is to provide a baseline may wish to start by defining the broad processes or when little objective evidence exists about a process. For systems most likely to underlie proximate causes. For example, a health care organization may want to learn more example, if a team is investigating a medication error about the current level of staff competence. A dementia involving the process used to communicate an order to the pharmacy and the process used by pharmacy staff long term care or psychiatric special care unit may want to to check the dosage ordered, the team may decide to know more about the effectiveness of the bed alarm systems measure the following for a defined period of time: to prevent patient falls and elopement. Specific indicators ►► Time elapsed between when an order is written by for a particular outcome or a particular step in a process medical staff and when the pharmacy receives the may be used by the organization for ongoing data collec- order by fax, pickup, phone, or e-mail tion. When assessed, these data can help management ►► Number of calls to prescribers for clarification of and staff determine whether a process is ineffective and an order needs more intensive analysis. Data about costs, including ►► Time elapsed between when the dosage is checked costs of faulty or ineffective processes, may also be of by pharmacy staff and when medication is dispensed significant interest to leaders and can be part of ongoing performance measurement. ►► Time elapsed between when medication is dispensed and when medication is administered Additional Data The second purpose of measurement is to gain more infor- needs to establish a baseline performance rate and continue mation about a process chosen for assessment and improve- to measure use. Staff can also use measurement to demon- ment. For example, a performance rate varies significantly strate that key processes (for example, the preparation and from the previous year, from shift to shift, or from the administration of medications) are in control. When a statistical average. Records may indicate that the staff process has been stabilized at an acceptable level of perfor- members on duty during weekend hours do not complete mance, the unit may measure it periodically to verify suicide risk assessments at intake. Or perhaps the data indi- sustained improvement. cate that patient observations are incomplete or infrequent when specific personnel are present. Perhaps patient assess- Choosing What to Measure ment methods or other care planning factors are suspected Choosing what to measure is absolutely critical at all stages as root causes of a sentinel event. Such findings may cause of root cause analysis—in probing for root causes and a health care organization to focus on a given process to in assessing whether a recommended change or action determine opportunities for improvement. represents an actual improvement (see Sidebar 4-2, above). Measurement requires indicators that are stable, consistent, The target for further study by the organization should be understandable, easy to use, and reliable. Indicators, or time limited and can test a specific population, a specific performance measures, are devices or tools for quantifying diagnosis, a specific service provided, or an organization the level of performance that actually occurs. They are valid management issue. Detailed measurement is then necessary if they identify events that merit review, and they are reli- to gather data about exactly how the process performs and able if they accurately and completely identify occurrences about factors affecting that performance (see Table A-4 in (see Checklist 4-1, page 71). 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 A third purpose of measurement is to determine the of an intervention. An outcome measure is a specific, effectiveness of improvement actions. For example, a measurable indicator of the end result of an action. For nursing unit that begins to use a new piece of equipment example, monitoring the number of speeding tickets

70 CHAPTER 4 | Determining Proximate Causes

Checklist 4-1 . trigger further investigation each time it occurs. Because Characteristics for Choosing an risk managers are very aware of such indicators, they can Appropriate Indicator or Measure ensure that each event is promptly evaluated to prevent future occurrences. 33 Quantitative—It is expressed in units of measurement. Although sentinel event indicators are useful to ensure 33 Valid—It identifies events that merit review. patient safety, they are less useful than aggregate data 33 Reliable—It accurately and completely identifies indicators in measuring the overall level of performance in occurrences. an organization. An aggregate data indicator quantifies a 33 A measure of a process or outcome—It involves process or outcome related to many cases. Unlike a sentinel a goal-directed series of activities or the results event, the events typically measured by an aggregate data of performance. indicator may occur frequently. Aggregate data indicators are divided into two groups: rate-based indicators and a person receives is a process measure of that person’s safety continuous variable indicators. as a driver. The number of car accidents that person has is an outcome measure of how safe a driver that person Rate-Based Indicators actually is. Rate-based indicators express the proportion of the number of occurrences to the entire group within which the occur- Outcome measures are often misleading in health care. For rence could take place, as in the following examples: example, a root cause analysis could be used to change a process that theoretically led to a sentinel event. The organi- Patients receiving cesarean sections zation can measure outcomes, and the sentinel event might All patients who deliver not occur again for many years. However, because sentinel events occur only rarely, it is difficult to make a direct Total number of elopements correlation between the outcome measure and the change. Patients at risk for elopement (wandering and confused) This is a limitation of the use of outcome measures to assess the effectiveness of process changes intended to reduce Patients with central line catheter infections the incidence of rare events. For example, if a wrong-site surgery typically occurs in each hospital only once every All patients with central line access devices four to five years, can a hospital that has gone without a wrong-site surgery for several years claim that the root cause Patient falls associated with adverse drug reactions analysis has led to improved outcomes? All patient falls

Examples of an outcome indicator are “catheter-associ- ated sepsis for patients with a central venous access device” The rate can also express a ratio comparing the occurrences or “percentage of patients at risk for falls who actually identified with a different but related phenomenon, as in experience falls while in the health care organization.” An the following example: example of a process indicator is “patients older than 65 having medication monitoring for drugs that can decrease Patients with central line infections renal function.” Central line days

Organizations may categorize indicators as measures of process or outcome. They can also classify indicators as Continuous Variable Indicators single-event indicators and aggregate data indicators. A This type of aggregate data indicator measures performance special type of single-event, outcome indicator is a sentinel along a continuous scale. For example, a continuous vari- event. A sentinel event indicator identifies an individual able indicator might show the precise weight in kilograms event or phenomenon that is significant enough to of a patient receiving total parenteral nutrition (TPN). Or

71 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

it might record the number of written pharmacist recom- Additional information on measurement, including how mendations accepted by the attending physicians. While to measure the effectiveness of improvement initiatives and a rate-based indicator might relate the number of patients ensure the success of measurement, appears in Chapter 6. approaching goal weights to the total number of patients on TPN, a continuous variable indicator measures the patient’s STEP 8: Design and Implement average weight change (that is, the patient’s weight one Immediate Changes month minus the patient’s weight the previous month). Even at this early stage, when the team has identified only proximate causes, some quick or immediate fixes may be Choosing what to measure is critical, and so is ensuring appropriate. For example, in the case of an organization that the data collected are appropriate to the desired that experiences the suicide of a patient who is not iden- measurement. See Figure 4-1, below, for criteria that will tified as being at risk for suicide, the organization could help the team ensure that the measure or indicator selected immediately evaluate its current risk assessment tool to is actually appropriate for monitoring performance. See learn whether it meets current standards of practice. The Checklist 4-2 on page 73 for key questions the team should organization could also address environment of care issues ask about measurement throughout the root cause analysis such as nonbreakaway showerheads and bed linens. process.

Figure 4-1 . Data Collection Evaluation Checklist DOWNLOAD

The Measure 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 Y N N/A Comments The data intended for collection are available.

The sources of the data and methods of collecting the data are defined.

Results Y N N/A Comments 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).

72 CHAPTER 4 | Determining Proximate Causes

Checklist 4-2 . • Moving and securing malfunctioning equipment from Key Questions About Measurement the area of care, treatment, or service

33 What will be measured? (This defines what is Immediate changes may also uncover additional causes that critical to determining root causes.) were previously masked but are critical to the search for the 33 Why will it be measured? (This verifies the criticality root cause(s). Immediate changes can be part of a perfor- of what will be measured.) mance improvement cycle to test process redesign before 33 What can be gained from such measurement? implementing it organizationwide. For instance, an (This describes the incentives of measurement.) organization may wish to test the use of new bathroom 33 Who will perform the measurement? hardware in one room before changing hardware 33 How frequent is the measuring? throughout the facility. 33 How will the data be used when measurement is completed? In addition, the organization could evaluate the assessment 33 Is the measure or measurement reliable? tool for suicide risk and the process used to check for 33 Is measurement a onetime event or a periodic or contraband, and it could then initiate meetings with the continuous process? medical staff to discuss revisions to requirements for 33 What resources are needed for measurement? histories and physicals. What is available? 33 Do the measures consider dimensions The organization could start conducting mandatory of performance? in-service training for all staff on suicide risk assessment. It also could place all patients with psychiatric or substance Teams conducting root cause analysis need not wait abuse diagnoses on suicide precautions. In the case of an until they finish their analysis to start designing and organization that experienced a wrong-site surgery, the implementing changes. During the process of asking organization could require a second staff member to observe “Why?” potential interventions emerge. Immediate operating room team procedures to assess compliance with changes may not only be appropriate but necessary. Teams the Universal Protocol for Preventing Wrong Site, Wrong may need to make these changes to reduce an immediate Procedure, Wrong Person Surgery™. Figure 4-2, page 74, risk such as the following: provides an example of a poster that can support staff • Repairing an unsecured window education on the Universal Protocol. • Removing an intoxicated employee from the environment

73 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Figure 4-2 . Data Collection Evaluation Checklist

TM Conduct a pre-procedure verification process

Address missing information or discrepancies before starting the procedure. UP • Verify the correct procedure, for the correct patient, at the correct site. Speak • 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 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 The 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. Universal • During the time-out, the team members agree, at a minimum, on the following: q correct patient identity Protocol q correct site q procedure to be done for Preventing Wrong Site, • When the same patient has two or more procedures: If the person performing the Wrong Procedure, and 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 Wrong Person Surgery™ of documentation.

Guidance for health care professionals 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 5

Identifying Root Causes

Learning Objectives Root Cause Analysis: Step-by-Step • Identify which systems underlie the proximate cause(s) of the event STEP 1: Organize a Team STEP 2: Define the Problem • Find the root causes within those systems that STEP 3: Study the Problem contributed to the event STEP 4: Determine What Happened • Consider how the root causes in different systems STEP 5: Identify Contributing Process Factors relate to and affect each other STEP 6: Identify Other Contributing Factors STEP 7: Measure—Collect and Assess Data on Proximate and Underlying Causes Tools to Use STEP 8: Design and Implement Immediate Changes 55STEP 9: Identify Which Systems Are Involved— The following tools will help a team identify The Root Causes root causes: 55STEP 10: Prune the List of Root Causes ►► Change analysis (see Figure 7-3, page 116) 55STEP 11: Confirm Root Causes and Consider ►► Fishbone diagram (see Figure 7-8, page 124) Their Interrelationships ►► Flowchart (see Figure 7-9, page 126) STEP 12: Explore and Identify Risk-Reduction Strategies ►► Gantt chart (see Figure 7-10, page 127) STEP 13: Formulate Improvement Actions ►► Histogram (see Figure 7-11, page 128) STEP 14: Evaluate Proposed ►► Multivoting (see Figure 7-12, page 129) Improvement Actions ►► Pareto chart (see Figure 7-14, page 132) STEP 15: Design Improvements ►► Relations diagram (see Figure 7-15, page 134) STEP 16: Ensure Acceptability of the Corrective Action Plan STEP 17: Implement the Improvement Plan STEP 18: Develop Measures of Effectiveness The analysis continues. At this point, the team has a and Ensure Their Success detailed description of the sentinel event or close call, a STEP 19: Evaluate Implementation of description of the patient care processes involved, and a Improvement Efforts list of proximate causes and other factors that might have STEP 20: Take Additional Action caused or contributed to the problem or could do so in STEP 21: Communicate the Results the future. The team has also started to collect data on proximate causes.

75 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

The Joint Commission’s Framework for Root Cause For a special cause in a process, teams should search for Analysis and Action Plan provides an example of the common cause in the system of which the process is a comprehensive systematic analysis. Please see a part. Keep asking, “Why did the special-cause variation the Appendix for the framework and its 24 analysis occur?” to identify one or more common-cause variations questions. These questions are intended to provide a in the supporting systems that may represent root causes. template for analyzing an event and an aid in organizing The team should review the processes and subprocesses the steps and information in a root cause analysis. 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 STEP 9: Identify Which Systems Are variation and the presence of special-cause variation. Involved—The Root Causes Now the team again asks, “Why did that proximate cause For example, a special cause emerges when one group of happen? Which systems and processes underlie proximate surgeons and their assistants do not follow hospital proce- factors?” The goal of asking questions at this stage is to dures for hand hygiene, resulting in a sentinel event. This identify the underlying causes for the proximate causes. For special cause might be part of a common-cause variation example, in the case of the elderly patient found dead on in a larger system: the hospital’s inconsistent education in the floor by her bed, questions might include the following: sterile techniques and hand washing. • Why was the patient not monitored for an hour to an hour and a half? A logical starting point in the team’s effort to determine • Why was a new graduate nurse assigned to this patient’s the systems involved with the sentinel event or close call is care? Did the nurse have the assistance of ancillary staff? listing and categorizing the possible causal factors. The team • How much orientation had the nurse completed? can categorize common or root causes of a sentinel event • Why was the patient given a sedative? in a health care organization according to the important • Why was the call light not by the patient’s hand? functions or processes performed by the organization. They • Was the patient assessed to be at risk for falling? include processes for the following: • Were interventions established? If so, why were they not done? TIP As in all stages of the process, it is critical to keep the team Clarify all issues. The team must clearly define focused on searching for system or common-cause prob- the issues regarding the patient safety event and lems rather than focusing on human errors. Teams often ensure that team members share a common have trouble at this stage of the root cause analysis. The understanding of the issues. No matter how tendency is to stop short after identifying proximate causes obvious the issues may seem, individual team and not to probe deeper. The probing must continue until members may not understand them in the same the team can no longer identify a reason underlying a cause. way. For example, a staff member may not The resulting cause, then, is a root cause. 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 Underlying causes may involve special-cause variation, surgery, surgical team members may not agree common-cause variation, or both. Being “special” or about whether the burn could have been affected “common” is not an inherent characteristic of the cause by the proximity of the oxygen cannula to the itself. Rather, it describes the relationship of the cause to cautery or how the cannula was handled during the a specific process or system. It is possible for the same cauterizing procedure. It’s critical that such issues cause to be a special cause in one process and a common be resolved and defined. cause in another.

76 CHAPTER 5 | Identifying Root Causes

• Human resources Asking concrete questions about each function listed above • Information management can help team members reach the essence of the problem— • Environmental management the systems that lie behind or beneath problematic • Leadership—embracing organization culture, processes (see Table 5-1, below, for a breakdown of causal encouragement of communication, and clear factors). At this stage, the team can word questions in the communication of priorities following form: “To what degree does . . . ?” Follow-up questions for each could be “Can this be improved, and if In addition, the team should consider factors beyond an so, how?” See Sidebar 5-1, page 78, for a fuller itemization organization’s control as a separate category. However, it of possible questions. needs to exercise caution in assigning factors to this category. Although a causative factor may be beyond an Other questions may emerge in the course of an analysis. organization’s control, the protection of patients from The team should fully consider all questions; they may the effects of the uncontrollable factor is within the be used to probe for systems that underlie problematic organization’s control in most cases and should be addressed processes. One team investigating a patient suicide found as a risk-reduction strategy. 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.

77 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 tend to reduce effective staffing levels? Can these their responsibilities? Can these qualifications be plans be improved, and if so, how? improved, and if so, how? ►► To what degree is staff performance in the operant ►► How did actual staffing at the time of the event processes addressed? Can such staff performance be compare with ideal levels? Can the staffing level be improved, and if so, how? 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 among participants? Can such communication be the barriers to information availability and access? To improved, and if so, how? what degree is the information accurate, complete, and unambiguous? Can these factors 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 been planned and tested? Can these responses be if so, how? 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 communicated as a high priority? How is such preven- so, how? tion 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 elimi- nated, 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?

78 CHAPTER 5 | Identifying Root Causes

• In the human resources area, the organization had not analyze each cause or factor using reasoning skills based on adequately assessed age-specific staff competence, and logic. Asking two questions helps clarify whether each cause staff needed additional training in management of or problem listed is actually a true root cause: suicidal patients. 1. If we fix this problem, will the problem recur in the • In the information management area, information future? about the patient’s past admission was not available. 2. If this problem is a root cause, how does it explain what Communication delays resulted in failure to implement happened or what could have happened? appropriate preventive actions. • In the environmental management area, the team Using three criteria to determine whether each cause is found that access to the appropriate unit for the patient a root cause or a contributing (or proximate) cause, the was denied. following three questions may then be asked: 1. Is it likely that the problem would have occurred if the Finding Multiple Causes cause had not been present? Patient safety events can be very complex and involve 2. Is the problem likely to recur due to the same causal multiple causes. Understanding causes is essential if the factor if the cause is corrected or eliminated? organization is to create lasting improvements. Certain 3. Is it likely that similar conditions will recur if the cause is tools can be particularly helpful in systematically looking corrected or eliminated? at an event to determine its causes. The tools are designed to help root cause analysis team members understand If the answer to each question is “no,” then the problem is processes and factors that contribute to both good and a root cause. If the answer to any of the questions is “yes,” problematic performance. Groups can also use the tools to then the problem is a contributing/proximate cause. It study a process, without requiring a statistical background. may be helpful to develop a checklist with these questions They may be used singly or in combination to show the built in. A sample checklist with the questions appears as relationship between processes and factors, reach conclu- Figure 5-2, page 82. sions, and systematically analyze causes. STEP 11: Confirm Root Causes and Fishbone diagrams are particularly helpful in categorizing Consider Their Interrelationships and visualizing multiple system or process problems that The team will very likely identify more than one root cause have contributed to a sentinel event or close call. The stan- for a sentinel event or close call. Even in those very rare dard categories coming off the main “spine” of the diagram instances when a sentinel event results from the intentional include people, procedures, equipment or materials, envi- act of an individual, more than one root cause is likely ronment, and policies. Such categories as communication, (for example, personnel screening, communication, and so education, leadership, and culture may also be appropriate forth). Sentinel events in industry tend to have two to four (see Figure 7-8, page 124). Subcauses branch off each major root causes, and these root causes tend to be interrelated. category. Figure 5-1, page 80, provides a handy way to help To date, The Joint Commission’s Sentinel Event Database ensure that the team has considered selected systems-based indicates four to six root causes identified by participating issues.

Ammerman proposed a classification system for causal TIP factors that is geared more toward a manufacturing environ- Organizations that have conducted a root cause ment.1 It may be helpful to review this (see previous Table analysis should consider having their findings 5-1) and other classification systems to ensure that the team and process reviewed by objective sources. The has identified all possible causal factors. Joint Commission uses a criteria-based review process to assess the quality of data derived from STEP 10: Prune the List of Root Causes a root cause analysis. The process assesses The team’s list of causal factors may be lengthy. Regardless the thoroughness and credibility of a root cause of the list’s length or the technique used, the team should analysis submitted to The Joint Commission.

79 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Figure 5-1 . Problematic Systems or Processes Checklist DOWNLOAD Human Resources Issues Qualifications

Staff Physicians Agency staff ¨ Defined ¨ Defined ¨ Defined ¨ Verified ¨ Verified ¨ Verified Reviewed and updated on a Reviewed and updated Reviewed and updated ¨ regular basis ¨ on a regular basis ¨ on a regular basis

Training

Staff Physicians Agency staff

Adequacy of training program Adequacy of training program Adequacy of training program ¨ content ¨ content ¨ content ¨ Receipt of necessary training ¨ Receipt of necessary training ¨ Receipt of necessary training Competence/proficiency testing Competence/proficiency testing Competence/proficiency testing ¨ following training ¨ following training ¨ following training Competence

Staff Physicians Agency staff ¨ Initially verified ¨ Initially verified ¨ Initially verified Reviewed and verified on a Reviewed and verified on a Reviewed and verified on a ¨ regular basis ¨ regular basis ¨ regular basis

Administration

Supervision of staff Current staffing levels Current scheduling practices

Adequate for new employees Based on a reasonable patient Overtime expectations ¨ ¨ acuity measure ¨ ¨ Adequate for high-risk activities ¨ Time for work activities ¨ Based on reasonable workloads Time between shifts for shift ¨ changes Information Management Issues

¨ Availability of information ¨ Accuracy of information ¨ Thoroughness of information ¨ Clarity of information ¨ Communication of information between relevant individuals/participants

80 CHAPTER 5 | Identifying Root Causes

Figure 5-1 . Problematic Systems or Processes Checklist continued Environmental Management Issues

Physical environment Systems to identify environmental risks ¨ Appropriateness to processes being carried out ¨ Quality control activities ¨ Lighting ¨ Adequacy of procedures and techniques ¨ Temperature control ¨ Inspections Noise control Planned, tested, and implemented emergency and ¨ ¨ failure-mode responses ¨ Size/design of space ¨ Exposure to infection risks ¨ Cleanliness Leadership and Communication Issues

Data use Planning Design of services and work processes ¨ Use in decision making ¨ For achievement of short-term and long-term goals ¨ Creation of communication ¨ Use to identify changes in channels the internal and external ¨ To meet challenge of external environments changes ¨ Performance improvement ¨ Introduction of innovation

Communication Staffing ¨ Present, as appropriate ¨ Sufficient number and mix of staff members ¨ Appropriate method ¨ 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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Figure 5-2 . Evaluation Checklist for Differentiating Root and Contributing Causes DOWNLOAD

Cause #1: ______Y N N/A Comments 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: ______Y N N/A Comments 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: ______Y N N/A Comments 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: ______Y N N/A Comments 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 interaction of the root causes is likely to be at the root of causes identified for various types of sentinel events are the problem. If an organization eliminates only one root provided in Table 5-2, page 83. cause, it has reduced the likelihood of that one very specific adverse outcome occurring again. But if the organization Although this information may provide insight into areas misses two other root causes, it is possible that those root to explore, organizations should not rely exclusively on causes could interact in another way to cause a different but these lists but should work to uncover their own unique equally adverse outcome. root causes. The root causes collectively represent latent conditions— The identification of all root causes is essential to conditions that exist as a consequence of management and preventing a failure or close call. Why? Because the organizational processes and that can be identified and

82 CHAPTER 5 | Identifying Root Causes

Table 5-2. Sample Root Causes Identified in the corrected before they contribute to mishaps. The combi- Sentinel Event Database nation of root causes sets the stage for sentinel events. Organizations that experienced the following types of sentinel Effective identification of all root causes and an under- events reviewed by The Joint Commission identified, among standing of their interaction can aid organizations in others, the root causes listed below. changing processes to eliminate a whole family of risks, not Unintended Retention of a Foreign Object just a single risk. • The absence of policies and procedures • Failure to comply with existing policies and procedures • Problems with hierarchy and intimidation If a team identifies more than four root causes, a number • Failure in communication with physicians of the causes may be defined too specifically. In this case, • Failure of staff to communicate relevant patient information the team may wish to determine whether one or more of • Inadequate or incomplete education of staff the root causes could logically be combined with another to reflect more basic, system-oriented causes. The team then Wrong-Patient, Wrong-Site, Wrong-Procedure should verify each of the remaining root causes. Doing so • Miscommunication by operating room teams • Insufficient orientation and training of staff involves cross-checking for accuracy and consistency all • Lack of procedural compliance facts, tools, and techniques used to analyze information. • Lack of available information Any inconsistencies and discrepancies should be resolved. • Distraction • Leadership issues How does an organization know whether and when it has Patient Falls identified all true root causes of a sentinel event? • Insufficient staff orientation and training • Inadequate caregiver communication Most root cause analysis teams ultimately reach a point • Inadequate assessment and reassessment where they ask themselves, “When can we stop asking • Unsafe environment of care ‘Why?’” This question is best answered by considering • Inadequate care planning and provision whether an identified cause is actionable in a way that will Suicides in a 24-Hour Care Setting likely prevent recurrences or otherwise protect patients • The environment of care, such as the presence of from recurrences. If the answer is “yes,” then it might be nonbreakaway bars, rods, or safety rails; lack of testing of acceptable to stop there, but it is by no means necessary to breakaway hardware; and inadequate security • Patient assessment methods, such as incomplete stop there. Even root causes can have deeper root causes— suicide risk assessment at intake, absent or incomplete they usually do. reassessment, and incomplete examination of patients (for example, failure to identify contraband) Organizations often struggle to identify root causes because • Staff-related factors, such as insufficient orientation or training, incomplete competency review or credentialing, they are reluctant to confront sensitive, politically charged and inadequate staffing levels issues such as organizational culture, resources, pressure • Communication issues and information-related factors, to produce or to move patients quickly through surgery, such as incomplete communication among caregivers and information being unavailable when needed and lack of leadership or support. Employees typically are reluctant to address the problems they perceive because Treatment Delays they fear that their candor could cause repercussions within • Inadequate communication among caregivers the organization. As a result, for root cause analysis to • Insufficient patient assessment be successful, it must be a confidential and nonpunitive • Continuum of care issues process. There must also be timely, relevant feedback to • Staff-related factors, such as insufficient orientation and training and insufficient competency and personnel reporting the adverse events to help them see that credentialing processes their input is meaningful.2 • Inadequate availability of information Health care employees often struggle with the root cause Source: The Joint Commission. Sentinel Event Data: General Information 2Q 2016 Update, Most Commonly Reviewed Sentinel Event Types, analysis process because it requires them to scrutinize not Accessed Jul 16, 2017. https://www.jointcommission.org/assets/1/18/Event only one another but also one another’s errors. A recent _type_2Q_2016.pdf. (This is the latest date for which this information is publicly available.) study of root cause analysis meetings found that even when

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the analysis focused on close-call situations that did not References result in death, staff members were extremely wary about 1. Ammerman M. The Root Cause Analysis Handbook: A Simplified how they positioned themselves in relation to the issues and Approach to Identifying, Correcting, and Reporting Workplace Errors. staff involved. The “talk” of root cause analysis work is New York: Productivity Press, 1998. difficult in all situations.3 2. Stecker MS. Root cause analysis. J Vasc Interv Radiol. 2007 Jan;18(1 Pt 1):5–8. A team should report its root cause findings to the leaders 3. Iedema RA, et al. Turning the medical gaze in upon itself: Root cause analysis and the investigation of clinical error. Soc Sci Med. of its organization. Leaders must be informed, as should 2006 Apr;62(7):1605–1615. 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.

84 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: Organize a Team • Set priorities and objectives for improvement in STEP 2: Define the Problem areas identified as at the root of the problem STEP 3: Study the Problem • Develop, test, implement, and measure the STEP 4: Determine What Happened effectiveness of improvement efforts STEP 5: Identify Contributing Process Factors STEP 6: Identify Other Contributing Factors STEP 7: Measure—Collect and Assess Data on Proximate and Underlying Causes Tools to Use STEP 8: Design and Implement Immediate Changes The following tools will help a team identify, STEP 9: Identify Which Systems Are Involved— implement, and monitor improvement The Root Causes opportunities: STEP 10: Prune the List of Root Causes ►► Affinity diagram (see Figure 7-1, page 114) STEP 11: Confirm Root Causes and Consider ►► Brainstorming (see Figure 7-2, page 115) Their Interrelationships STEP 12:  ►► Change management (see Figure 7-4, page 117) 55 Explore and Identify Risk-Reduction Strategies ►► Failure mode and effects analysis (see Figure 55STEP 13: Formulate Improvement Actions 7-7, page 122) 55STEP 14: Evaluate Proposed ►► Flowchart (see Figure 7-9, page 126) Improvement Actions ►► Gantt chart (see Figure 7-10, page 127) 55STEP 15: Design Improvements ►► Histogram (see Figure 7-11, page 128) 55STEP 16: Ensure Acceptability of the Corrective ►► Multivoting (see Figure 7-12, page 129) Action Plan ►► Operational definition (see Figure 7-13, 55STEP 17: Implement the Improvement Plan page 130) 55STEP 18: Develop Measures of Effectiveness and Ensure Their Success ►► Pareto chart (see Figure 7-14, page 132) 55STEP 19: Evaluate Implementation of ► (see Figure 7-15, page 134) ► Relations diagram Improvement Efforts ►► Run chart (see Figure 7-16, page 135) 55STEP 20: Take Additional Action ►► Scatter diagram (see Figure 7-17, page 137) 55STEP 21: Communicate the Results ►► SIPOC process map (see Figure 7-18, page 138) ►► Stakeholder analysis (see Figure 7-19, page 140) The team asks, “So what are we going to do with the prob- ►► Standard work (see Figure 7-20, page 142) lematic systems now that we have identified them?” When ►► Value stream mapping (see Figure 7-21, the team has a solid hypothesis about one or more root page 144) causes, the next step is to explore and identify risk-reduction strategies to help ensure that system flaws are corrected. 85 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

The Joint Commission’s Framework for Root Cause for individuals to make mistakes. By compensating for Analysis and Action Plan provides an example of less-than-perfect human performance, engineering systems a comprehensive systematic analysis. Please see achieve a high degree of reliability through process the Appendix for the framework and its 24 analysis standardization, backup systems, and designed redundancy. questions. These questions are intended to provide a A failure rate as low as even 1% is not tolerated. The template for analyzing an event and an aid in organizing emphasis is on systems rather than individuals. 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, STEP 12: Explore and Identify substantially exceeds that in health care. What lessons can Risk-Reduction Strategies these industries teach health care professionals that could be Organizations that have root cause analysis experience adapted to the health care system in order to move organi- should consider conducting data analysis of multiple root zations toward high reliability? cause analyses. Sentinel and adverse events are not isolated occurrences—organizations have often identified the Lucian L. Leape, MD, is a pioneer in comparing risk- underlying root causes in past root cause analyses as reduction approaches in various other industries to those contributing or root causes of other, similar occurrences. in the health care industry. He suggests four safety design They often will find, through root cause analysis, dissimilar characteristics from the aviation industry that could, with events can have certain root causes in common. This kind some modification, prove useful in improving safety in the of convergence to common root causes by separate root health care industry1: cause analyses of dissimilar events is a good demonstration • Built-in multiple buffers, automation, and redundancy. that root cause analyses are delving deeply enough. Instrumentation in airplane cockpits includes multiple The questions root cause analysis teams need to ask and purposely redundant monitoring instruments. are the following: The design systems assume that errors and failures are • What have we done before? inevitable and should be absorbed. • What worked? • Standardized procedures. Protocols that must be followed • What didn’t work? Why not? exist for operating and maintaining airplanes. • Why are we continuing to have this type of event? • A highly developed and rigidly enforced training, After a team is ready to move forward with a risk-reduction examination, and certification process. Pilots take strategy, it must start by exploring relevant literature on proficiency exams every six months. risk-reduction and error-prevention strategies. Much has • Institutionalized safety. The airline industry reports been written by experts in the field about the engineering directly to two agencies that regulate all aspects of flying, approach to failure prevention and how it differs from the prescribe safety procedures, and investigate all accidents. medical approach. Some of the literature’s key points are A confidential safety reporting system established by described below. the Aviation Safety Reporting System operated by the National Aeronautics and Space Administration The pervasive view of errors in the engineering field is that enables pilots, controllers, or others to report dangerous humans err frequently and that the cause of an error is situations, including errors they have made, to a third often beyond the individual’s control. In designing systems party without penalty. This program greatly increases and processes, engineers begin with the premise that error reporting in aviation, resulting in enhanced anything can go wrong—and will. (Recall the Swiss cheese communication and prompt problem solving. model discussed in Chapter 1.) Their role is a proactive one: to design accordingly. Because engineering-based industries Organizations planning risk-reduction strategies should do not expect individuals to perform flawlessly, they consider three levels of design to reduce the risk of harm incorporate forcing functions into their designs—that is, to patients: they try to design systems that make it extremely difficult

86 CHAPTER 6 | Designing and Implementing a Corrective Action Plan for Improvement

1. Design the process to minimize the risk of a failure. patient needs is an essential principle of modern medicine; 2. Design the process to minimize the risk that a failure variation to meet individual health care organization or will reach the patient. practitioner preferences need not be. Standardization will 3. Design the process to mitigate the effects of a failure that get better overall results more safely—even if each practi- reaches the patient. tioner might individually get better results than the others by using a personally favored but different process than These levels are similar to the epidemiological concepts others. Practitioners do not work alone within health care of degrees of disease prevention, which can be defined organizations; they are members of teams, and those teams as follows2: interact with other teams. Thus, assuming each personally • Primordial prevention: minimizes hazards to health. favored practice is a good practice, it matters less which • 1° prevention: reduces the risk of disease. process is selected as the basis for standardization than that • 2° prevention: reduces the prevalence of disease. the process is performed consistently for safety. • 3° prevention: reduces the impact of complications. A Systems Approach to Risk Reduction A consideration for the first level of design might be Risk-reduction strategies must emphasize a systems ensuring a positive interlock between tubes in a venti- rather than an individual human approach. A system lator airflow circuit that might prevent a failure such as an can be thought of as any collection of components and inadvertent disconnection of the tubes. Next, a consider- the relationships between them, whether the components ation for the second level of design might be ensuring that are human or not, when the components have been there is an airway pressure alarm that can detect a pressure brought together for a well-defined goal or purpose.3 drop due to a tubing disconnection and alert staff before a As Leape writes, “Creating a safe process, whether it patient is harmed. Finally, a consideration for the third level be flying an airplane, running a hospital, or performing of design is the ready availability of resuscitation equipment cardiac surgery, requires attention to methods of error that can mitigate the effect of oxygen deprivation due to a reduction at each stage of system development: design, prolonged tubing disconnection. construction, maintenance, allocation of resources, training, and development of operational procedures.”1(p. 1854) If errors It is also critical that error-prevention strategies used include are made, if deficiencies are discovered, individuals at each standardizing tasks and processes to minimize reliance on stage must revisit previous decisions and redesign or weak aspects of cognition, testing professional performance, reorganize the process. and institutionalizing safety through close call and nonpuni- tive reporting. For example, clinical practice can design Designing for safety means making it difficult for humans guidelines, organization policies, and protocols to reduce to err. However, organizations that design systems must inappropriate variation in patient care and help reduce the recognize that failures do occur and build recovery or likelihood of failures. In a general sense, the consistency correction into the system. If that is not possible, indi- with which a process is carried out (or standardized) viduals will need to detect failures promptly so they have diminishes the tendency for a process failure. However, in time to take corrective actions. For example, as required by recent years practitioners have met with limited enthusiasm The Joint Commission’s Universal Protocol for Preventing attempts to standardize health care processes, such as Wrong Site, Wrong Procedure, Wrong Person Surgery™, through the introduction of practice parameters, protocols, medical staff must use a preprocedure verification process. clinical pathways, and so forth. Such processes are only For example, they could use a checklist to confirm appro- slowly affecting the actual delivery of care. priate documents (such as medical records and imaging studies) are available. The Universal Protocol also states that Achieving process consistency while recognizing and the procedure site must be marked. Ideally, the marking accommodating variation in the process (for example, the takes place with the patient involved, awake, and aware, if patient’s severity of illness, comorbidities, other treatments, possible. Finally, a time-out is performed immediately prior and preferences) is one of the major challenges to health to starting the procedure so the medical team can confirm care standardization. Process variation to meet individual the correct patient, site, positioning, and procedure and, as

87 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

applicable, verify that all relevant documents, related infor- Fail-safe design is also a concept familiar to high reliability mation, and necessary equipment are available. industries, including aerospace and nuclear engineering. The design may be fail-passive, fail-operational, or fail- Organizations must eliminate risk points—specific points active. For example, a circuit breaker is a fail-passive device in a process that are susceptible to failure or system break- that opens when a dangerous situation occurs, thereby down—through design or redesign efforts. They generally making an electrical system safe. A destruct system on a result from a flaw in the initial design of the process or satellite or an air-to-air missile is an example of a fail-active system, a high degree of dependence on communication, device. If the satellite or missile misses its target within a set nonstandardized processes or systems, and/or failure or time, the destruct system blows the satellite or missile apart absence of backup. to halt its flight and limit any damage it might cause by falling to the ground. Checklist 6-1, below, provides the key For example, risk points during the medication use risk-reduction strategies suggested in the medical and process include interpretation of an illegible order by a engineering literature. pharmacist and the time during which a registered nurse mixes the medication dose to administer to a patient. In Risk points and risk-reduction strategies for wrong site surgical procedures requiring the use of lasers, a risk surgery, suicide, and infant abductions or release to wrong point occurs during the use of anesthetic gases: The high families are also provided in Sidebar 6-1. Not all these concentration of oxygen, if not properly synchronized strategies are specific Joint Commission requirements, with use of the laser, can allow tubes, drapes, and but they are presented for consideration by all health other potentially flammable materials to ignite. During care organizations. preoperative procedures, verification of the body side and site constitutes a risk point. Root Cause Analysis in Proactive Risk Assessment Built-in buffers and redundancy, task and process simplifi- Expanding the use of risk assessment has emerged as a cation and standardization, and training are all appropriate strong trend in health care. Facilities can implement a design mechanisms to reduce the likelihood of failure at risk points and elsewhere. For example, prior to the admin- Checklist 6-1 . istration of medications, staff can perform multiple and Identifying Risk-Reduction redundant checks such as asking the patient his or her name Strategies and checking the patient’s armband to confirm that a medi- cation is given to the right patient. See Sidebar 6-1, on page 33 Use an engineering (proactive, systems-based) 89, for risk points for medication errors and risk-reduction approach to failure prevention. strategies to prevent such failures. 33 Start with the premise that anything can and will go wrong. Systems engineering literature includes numerous other 33 Design systems that make the safest thing to do the easiest thing to do. design concepts that could be useful tools to prevent failures and sentinel events in health care organizations. 33 Design systems that make it difficult for individuals to err. Redundancy is one such concept familiar to the aerospace 3 Build in as much redundancy as possible. and nuclear power industries, where systems have backups 3 and even the backups normally have backups. 33 Use fail-safe design whenever possible. Organizations can increase system reliability by introducing 33 Simplify and standardize procedures. redundancy into system design. However, the cost of 33 Automate procedures. designing in redundancy is an issue in most health care 33 Ensure rigidly enforced training and competence environments. The engineering literature also describes assessment processes. the benefits of simplification, standardization, and 33 Ensure nonpunitive reporting of close calls. loose coupling to reduce the possibility of 33 Eliminate risk points. systems-related problems.

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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, perform daily rounds with physicians, work with regis- prompt for allergies, and provide information on drug– tered nurses, and serve as on-site resources. drug and drug–food interactions).

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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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:

►► Address education and training issues (orientation, using electronic order entry. competence assessment, and training with new medi- ►► Discourage use of acronyms and abbreviations in cations and devices). general and prohibit the use of specific, high-risk acro- ►► Support professional ethics and judgment. nyms and abbreviations.

►► 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 ►► Make sure site marking is visible after draping. intraoperative fluoroscopy.

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 emer- hazards as door frames, doorknobs, showerheads, and gency department) bedsheets

90 CHAPTER 6 | Designing and Implementing a Corrective Action Plan for Improvement

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 ►► Update policies on patient observation. every shift.

►► 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 newspapers. abduction situations during staff orientation and in-ser- ►► Consider options for controlling access to the nursery vice curriculum programs. or postpartum unit, such as swipe-card locks, keypad ►► Enhance parent education concerning abduction risks locks, entry point alarms, or video surveillance. (Any and parent responsibility for reducing risk, and then locking systems must comply with fire codes.) assess the parents’ level of understanding. ►► Consider implementing an infant security tag or abduc- ►► Attach secure identically numbered bands to the baby tion alarm system. (wrist and ankle bands), mother, and father or signifi- cant 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.

91 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

strategy of assessing risk proactively by using failure mode Sidebar 6-2 . and effects analysis (FMEA) to identify risk-reduction The Interrelationship Between opportunities. Also known in the literature as failure mode, FMEA and RCA effects, and criticality analysis (FMECA), FMEA offers a systematic way of examining a design prospectively for Failure mode and effects analysis (FMEA) and root possible ways in which failure can occur. This approach cause analysis (RCA) differ in critical ways but also identifies potential failures in terms of failure modes or share similarities. symptoms. Organizations study the effect on the total The fundamental difference is timing: RCA is a retro- system or process for each failure mode, and identify factors spective approach, while FMEA is designed to keep that might cause or enable those failures. sentinel events from occurring in the first place. RCA asks “Why?” after an event occurred to identify the root Actions (planned or already taken) can be reviewed by causes of an event. FMEA asks “What if?” to explore organizations for their potential to minimize the probability what could happen if a failure occurred at a particular step in a process or link. of failure or to reduce the effects of failure. FMEA’s goal is to prevent poor results, which in health care means harm FMEA and RCA have the following characteristics to patients. Its greatest strength is its capability to focus in common: users on the process of redesigning processes to prevent the ►► Nonstatistical method of analysis occurrence of failures. ►► Goal of reducing the possibility of future patient harm

Although the technique has been used effectively in the ►► Involves identifying conditions that lead to harm engineering world since the 1960s, its use in the health care ►► Team activity world began as late as the 1990s. FMEA is now gaining In addition, the two methodologies can be—and often broader acceptance in health care as a tool for prospective are—interconnected. FMEA can be used during an RCA analysis due to the efforts of The Joint Commission, the to help evaluate various improvement strategies that Department of Veterans Affairs National Center for Patient resulted from the RCA. FMEA can look at where the Safety, and the Institute for Safe Medication Practices, various strategies might fail and identify any new failure among others. FMEA is discussed further in Chapter 7. modes that have been introduced as a result of new design processes. RCA can be used to identify the root FMEA is described here because root cause analysis teams causes of failure modes. may also wish to use FMEA to proactively identify risk-re- duction opportunities during their root cause analysis of a root cause analysis, or the organization might select new sentinel event or close call or to carry out a proactive risk members as required by the recommended improvements. assessment on a process that is being redesigned in response to the findings of a root cause analysis. The interrelation- Improvement actions fall into three basic categories: ship between FMEA and root cause analysis is further 1. Actions to prevent errors discussed in Sidebar 6-2, right. 2. Actions to shield the patient from the effects of an error 3. Actions to mitigate the effects of an error that reaches STEP 13: Formulate Improvement the patient Actions With the list of root causes in hand, the team is now ready “Mistake Proofing” to start devising potential solutions to systems- The ultimate goal of a root cause analysis is the develop- related problems. Known as corrective actions or improve- ment of actions to reduce the potential for recurrence of ment actions, these solutions are required to prevent a a similar event. The initial focus of improvement actions problem from occurring or recurring due to the same root should be on eliminating the circumstances that allowed cause(s) or interaction of root causes. The team may include the outcome. If no action can be applied to eliminate the the same members as during the early stages of 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 Practice guidelines or parameters and other standardized systematic approach to mistake-proofing processes to avoid patient care procedures are useful reference points for human error in care delivery. comparison. Whether developed by professional societies or in-house practitioners, these procedures represent an A more recent attempt to incorporate mistake proofing in expert consensus about the expected practices for a given design is the “smart pump” system for medication infusion. diagnosis or treatment. Assessing variation from such This system prevents errors by “remembering” the organi- established procedures can help the team identify how to zation’s defined dosing limits and other clinical advisories improve a process. entered into the medication library and applying those “rules” during pump programming. This system helps to Returning to the sentinel events described in Chapter 3, ensure that the right dosage of the medication is infused. consider the following examples of how root cause The system also alerts clinicians about potential unsafe drug analysis teams could approach the identification of therapy before the medication is administered.5 improvement actions.

When formulating corrective action plans, teams should In the suicide example, the team has completed a fish- analyze the strength of their proposed solutions. The US bone diagram indicating multiple system problems, Department of Veterans Affairs National Center for Patient including assessment of suicide risk, environment of care, Safety has devised a hierarchy of corrective actions that can and emergency procedures. The team might break into be used to gauge the effectiveness of improvement actions smaller subgroups. One group (including the psychiatrist, based on how likely they are to reduce vulnerability to an medical staff leader, and nurse) would address the failed adverse event (see Table 6-1, page 94).6 patient assessment process. They might start by reviewing the current standard for assessment of suicide risk and how Stronger actions typically involve modifications to the phys- this standard is communicated in the behavioral health care ical environment. For example, after a patient attempted unit. Another group (including the administrator and plant to commit suicide by hanging from an exposed pipe, the safety representative) might start working on environment organization removed the pipe. Weaker actions include of care issues such as nonbreakaway showerheads. Another changes in policies, procedures, and training. Although group (including emergency department physicians and the they are necessary components of an improvement action, nursing staff) might work on emergency procedures. they are considered weaker because they do not change the underlying conditions that lead to errors. They tend to rely In the elopement example, the root cause analysis team has on human cooperation and vigilance to succeed, and they identified multiple system problems, including an unsafe often show less immediate results. In a study of root cause environment of care; inadequate assessment and reas- analysis corrective action plans reported by the NCPS, sessment; and inadequate staff orientation, training, and stronger actions were easier to implement and more effec- ongoing competence assessment. One subgroup (including tive than weaker actions.7 the safety director, a nurse from the unit, and a social worker) might address possible actions to improve the Improvement actions should be formulated by thinking in long term care organization’s security and safety measures. terms of the everyday work of the organization. Work can Another small group (including the medical director, be defined in terms of functions or processes. A function director of nursing, activity staff member, and unit staff is a group of processes with a common goal, and a process nurse) might address opportunities to improve the process is a series of linked, goal-directed activities. Improvement used to assess and reassess patients at risk for elopement. actions should be directed primarily at processes. As stated Another group (including the medical director, the director earlier in this book, process improvement holds the greatest of nursing, and the performance improvement coordinator) opportunity for significant change, whereas changes related might address strategies to ensure that staff know elope- to an individual’s performance tend to have limited effect. ment risk factors and who is at risk for elopement and are Competent people often find themselves carrying out assessed regularly for competence in identifying and caring flawed processes. for at-risk patients.

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Table 6-1. Action Hierarchy DOWNLOAD

Action Category Example Stronger Actions Architectural/physical plant changes Replace revolving doors at the main patient entrance (These tasks require into the building with powered sliding or swinging less reliance on doors to reduce patient falls. humans to remember New devices with usability testing Perform heuristic tests of outpatient blood to perform the task glucose meters and test strips and select the most correctly.) 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. Intermediate Redundancy Use two RNs to independently calculate high-alert Actions 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 Conduct patient handoffs in a simulation lab/ periodic refresher sessions and observations 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. Enhanced documentation, communication Highlight medication name and dose on IV bags. Weaker Actions Double checks One person calculates dosage, another person (These tasks require reviews their calculation. more reliance on Warnings Add audible alarms or caution labels. humans to remember to perform the task New procedure/memorandum/policy Remember to check IV sites every 2 hours. correctly.) 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 identi- Wilson and colleagues suggest using the scientific method to fied system problems that led to the missed diagnosis of develop a list of potential solutions. They restate the scien- metastasized breast cancer. They include communication tific method in terms of steps used in developing solutions8: problems between caregivers, insufficient staff orientation 1. Become familiar with all the aspects of the problem and and training, and inadequate information management. its causes. Subgroups of the ambulatory health care organization’s 2. Derive a number of tentative solutions. team probe each of these areas for improvement opportu- 3. Assemble as much detail as is needed to clearly define nities, looking at such issues as care documentation and the what is required to implement these solutions. availability of clinical records, the timeliness and thorough- 4. Evaluate the suggested solutions. ness of initial and regular reassessments, and shift-to-shift 5. Objectively test and revise the solutions. communication of information related to patient needs. 6. Develop a final list of potential solutions.

In the medication error example, the root cause analysis These steps may assist the team through the process of both team has identified communication of medication orders developing and evaluating improvement actions. and the failure to ensure safe medication storage and access as two key problems, among others. A subgroup (including STEP 14: Evaluate Proposed the information technology staff member, pharmacist, Improvement Actions medical director, and home health nurse) might investi- When the list of possible improvement actions is as gate possible strategies to improve the accuracy of orders complete as possible, the team is ready to evaluate the communicated to local pharmacies. Another subgroup, alternatives and select those actions to be recommended including the nursing supervisor, pharmacy supplier, home to leadership. health nurse, and medical director, might investigate strat- egies to guard against medication theft and ensure proper To begin the evaluation process, the team should rank the implementation of the home health agency’s medication ideas based on criteria defined by the team. Gathering administration policies and procedures. appropriate data is critical to this process. A simple 6-point scale ranging from a low rank of 0 for the worst alterna- For each root cause, the team should work interactively tive to a high rank of 5 for the best alternative can be used either as a whole or in smaller groups to develop a list of at this point. To rank the proposed solutions, Ammerman possible improvement actions. Brainstorming can be used suggests using criteria such as compatibility with other to generate additional ideas. The emphasis at this point is organization commitments and the possible creation of on generating as many improvement actions as possible, other adverse effects.9 not on evaluating the ideas or their feasibility. The number of suggested improvement actions may vary based on the Initially, to prevent groupthink, it is a good idea to ask each nature of the root cause and how it relates to other root team member to rank the ideas on his or her own. The causes. To ensure as thorough a list as possible, the team rankings can then be consolidated into a team ranking. may wish to review the analyses of information used to identify root causes. Remember to encourage any and all FMEA may be a helpful tool at this point in the process. ideas without critiquing them. In the hands of a skilled FMEA involves evaluating potential problems (or improve- facilitator, even the seemingly wildest idea can lead to an ment actions) and prioritizing or ranking them on a proac- effective improvement action during later stages of anal- tive basis according to criteria defined by a team. ysis. Tools used such as flowcharts or fishbone diagrams can prompt additional solutions. Ask questions of the group, At the very least, every improvement action proposed by such as the following: the team should be objective and measurable. If it is • What might fix this problem? objective, implementation is easier and those affected by • What other solutions can we generate? the change are more likely to be receptive. If it is measur- • What other ideas haven’t we thought of? able, 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 Checklist 6-2 . that the team reaches a consensus on which criteria are Criteria for Evaluating most relevant to the organization. Ranking the proposed Improvement Actions ideas according to multiple criteria adds critical dimension to the evaluation. 33 Likelihood of success (preventing recurrence or occurrence) within the organization's capabilities In evaluating potential improvement actions, the team 33 Compatibility with organization's objectives should consider the impact of the suggested improve- 33 Risk ment on organization processes, resources, and schedules. 33 Reliability Sentinel events or close calls frequently shake up the orga- 33 Likelihood to engender other adverse effects nization’s notions of the resources that should be expended 33 Receptivity by management/staff/physicians in particular areas. Organizations contemplating a design 3 Barriers to implementation or redesign effort will certainly weigh the availability 3 Implementation time of resources against the potential benefits for patients, 33 customers, and the organization. 33 Long-term (versus short-term) solution 33 Cost Asking some key questions helps the team identify the 33 Measurability 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? Organization Processes • What initial and ongoing training will be required? • How does the proposed action relate to other • How will this impact the schedule, and how will its projects currently under way in the organization? Are impact be handled? there redundancies? • How does the action affect other areas and processes? Potential Negative Consequences • What process-related changes might be required? • Could this action cause problems in other areas or have a • Can affected areas absorb the changes or additional negative impact on other processes? responsibilities? • Is there a process in place to analyze and take action if there are unintended, negative consequences from Resources implementing this action? • What financial resources will be required to implement • Will the amount of resources required for this action the action? (Include both direct and indirect costs— detract from other quality improvement or patient that is, costs associated with the necessary changes to safety initiatives? other procedures and processes.) How will these resources be obtained? With answers to these questions in hand, the team can • What other resources (staff, time, management) are better gauge whether the pluses outweigh the minuses. required for successful implementation? How will these The team then may wish to revisit the ranking exercises resources be obtained? described previously. Doing so can help clarify which • What resources (capital, staff, time, management) are corrective improvement actions should be selected. To required for continued effectiveness? How will these summarize the potential of each proposed action, the resources be obtained? team can ask, “What will result from implementing this • What other activities will have fewer resources as a result action?” and “What would result from not implementing of shifting resource allocation for this change? this action?”

Schedule At this point, the team should be ready to select a finite • In what time frame can implementation be completed? number of improvement actions. Each action must do • Who will be responsible for making sure it happens? the following:

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• Address a root cause. required to meet these expectations? How and what will the • Offer a long-term solution to the problem. team measure to determine whether the process is actually • Have a greater positive than negative impact on other performing at the level expected? processes, resources, and schedules. • Be objective and measurable. The organization or group needs specific tools to measure • Have a clearly defined implementation time line. the performance of the newly designed or improved process • Be assignable to staff for implementation. to determine whether expectations are met. They can derive • Be acceptable to staff most directly affected by these measures directly, adapt them from other sources, the change. or create new tools, as appropriate. It is important for the measures to be as quantitative as possible, meaning that The next section describes how the team designs improve- the measurement can be represented by a scale or range ments and develops a corrective action plan covering each of values. For example, if the team cites improving staff of these aspects. competence in calculating medication doses as a corrective solution, the measure should evaluate competence before STEP 15: Design Improvements and after each training or educational session. If pretraining The product of the root cause analysis is a corrective competence tests at 80% to 85% proficiency, posttraining action plan that identifies the strategies that the organi- competence might be set at 90% to 95% proficiency. Or, in zation intends to implement to reduce the risk of similar the patient suicide example described back in Sidebar 3-1, events occurring in the future. The team is now ready to page 48, measures might include the percentage of accu- start drafting such a plan. The plan should address the five rately and appropriately completed suicide risk assessments issues of what, how, when, who, and where involved in as determined through peer review and the percentage of implementing and evaluating the effectiveness of proposed rooms with breakaway shower fixtures. improvement actions. At times, it may be difficult to establish quantitative Issue One: What measures—the improvement simply seems to lend itself Designing what involves determining the scope of the more to qualitative measures. Quantification of improve- actions and specific activities that will be recommended. A ment is critical, however, and even when teams measure clear definition of the goals is critical. To understand the solutions only in terms of risk-reduction potential, it is potential effects of the improvement activity, the organiza- important they try to quantify such potential as much as tion must determine which dimension of performance— possible through concrete measures. safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity10—will be affected. At times, the team Issue Three: When must consider the relationship between two or more dimen- Next, the team must define when the organization will sions. Redesign in response to a sentinel event most often meet its improvement goals. What time frame will the focuses on safety, but it may affect any or all of the other team establish for implementing the improvement action dimensions. What specific activities will organizations need and its essential steps? What are the major milestones and to achieve the necessary improvement? their respective dates? A Gantt chart of one organization’s improvement plan appears as Figure 6-1, pages 98–99. Issue Two: How How does the organization expect, want, and need the Issue Four: Who improved process to perform? The team carrying out the Who is closest to this process and therefore should “own” effort should set specific expectations for performance the improvement activity? Who should be accountable at resulting from the design or improvement. Without these various stages? To a great extent, the success of an improve- expectations, the organization cannot determine the degree ment effort hinges on involving the right people from all of success of the efforts. These expectations can be derived disciplines, services, and offices involved in addressing the from staff expertise, consumer expectations, experiences process. The process for taking action consists of several of other organizations, recognized standards, and other stages, each of which may have different players. sources. What sequence of activities and resources will be 97 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

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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The group that creates the process should include the Issue Five: Where people responsible for the process, the people who carry Where will the group implement the improvement action? out the process, and the people affected by the process. As Will its implementation be organizationwide, in a selected appropriate, the group members could include staff from location, with a selected patient population, or with different units, branch offices, or teams, services, disciplines, selected staff members? Are the location, target population, and job categories. When the group needs a perspective not and target staff of the improvement action likely to expand offered by its representatives, it should conduct interviews with success? These questions must be resolved before or surveys outside the group or invite new members into implementation. the group. It is important the group consider customers and suppliers such as purchasers, payers, physicians, referrals, Figure 6-2, below, provides a template for the team to accreditors, regulators, and the community as a whole. 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, Considering the Impact of Change managers are responsible for processes within their areas. When designing improvements, the team should also Upper management or a team of managers should oversee consider the impact of change on the organization. No design or redesign of processes with a wider scope. Leaders matter how minor, improvements require change, and it is must ensure that the people involved have the necessary normal for individuals and organizations to resist change. resources and expertise. Furthermore, their authority to Resistance to change can come from inertia, the challenge make changes should be commensurate with their responsi- of managing the change process, the challenge of obtaining bility for process improvements. Although regular feedback necessary knowledge to ensure effective implementation of and contact with management are important, rigid control the change, and resource limitations. can stifle creativity.

Figure 6-2 . Integrating the Improvement Plan DOWNLOAD

Planned Improvement: ______

Date of Areas for Individuals Other Steps to Be Taken Implementation Implementation Responsible 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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Change comes in two basic forms: physical and behavioral. STEP 16: Ensure Acceptability of the A physical change as a result of a root cause analysis Corrective Action Plan might be the use of new equipment, such as medication The team has defined the what, how, when, who, and administration carts. Behavioral change occurs when staff where in a corrective action plan. How does the team know members abandon established processes and procedures for whether it is acceptable to The Joint Commission or Joint corrective ones. 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 As mentioned in Chapter 1, The Joint Commission or JCI team leaders gain better insight to their behavior, which in will consider a corrective action plan acceptable if it does turn can help leaders identify motivators for personnel to the following: adopt and maintain desired behaviors. Leaders with this • Identifies changes to be implemented to reduce risk or awareness can also direct project resources to areas where formulates a rationale for not undertaking such changes they will have the greatest impact. • Where improvement actions are planned, identifies who is responsible for implementation, when the action will The stages of change theory posits that when individ- be implemented (including any pilot testing), and how uals attempt to change a behavior, they progress along a the effectiveness of the actions will be evaluated continuum of five phases: precontemplation, contempla- tion, preparation, action, and maintenance.11 By gauging The corrective action plan also should include resource where stakeholders are on the continuum, root cause considerations, leadership approval, and buy-in by affected analysis teams can identify the motivators that encourage staff. Teams should consider conducting an FMEA of the behavioral change. proposed corrective action plan and then proceeding with some pilot testing. For example, an organization planning to introduce stan- dardized order sets might learn through surveys, inter- Checklist 6-3, page 102 lists the criteria for an acceptable views, and in-person discussions that cardiologists have not corrective action plan. thought about standardizing their order sets. Each cardiol- ogist uses his or her own set and is content with it that way. STEP 17: Implement the These physicians do not see a need for change; they are in Improvement Plan the precontemplation stage. When an organization establishes the goals for improve- ment, it can start planning and carrying out the improve- The transition from precontemplation to contemplation is a ments. The team can implement a pilot test of the difficult one. People who do not recognize a need to change improvement on a small scale, monitor its results, and are less likely to change behavior than people who are refine the improvement actions. The pilot test enables the already considering it. In this situation, the team would team to ensure that the improvement is successful before have more success implementing standardized order sets committing significant organization resources. Pilot testing with a group of physicians who already recognize the also aids in building support for the improvement plan, potential benefits. thereby facilitating buy-in by opinion leaders. To pilot- test an improvement, the team should follow a systematic These physicians would be in the contemplation stage, and method that includes measuring success, evaluating when provided with the necessary information, resources improvement efforts, taking additional actions (if neces- (for example, template order sets, best practices, the latest sary), and communicating results. evidence and quality measures), and tools (such as content and process management systems), they will likely be A systematic method for design or improvement of willing to adopt the new behavior. processes can help organizations pursue identified

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DMAIC Checklist 6-3 . Criteria for an Acceptable Corrective Another process improvement model goes by the acronym Action Plan DMAIC (pronounced duh-MAY-ick), as shown in Figure 6-3 page 103. The letters stand for Define, Measure, Analyze, 33 Identifies changes to reduce risk or provides Improve, and Control, the five phases of the process. Used rationale for not undertaking changes in root cause analysis, DMAIC acts like a funnel, filtering 33 Identifies who is responsible for implementation through the proximate causes to the most likely root 33 Identifies when action(s) will be implemented cause(s), as shown in Figure 6-4, page 104. 33 Identifies how the effectiveness of action(s) will be evaluated 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: opportunities. A standard yet flexible process for carrying out these changes should help leaders and others ensure that Define: What is the problem? Form and develop a actions address root causes, involve appropriate personnel, project charter. and result in desired and sustained changes. Depending on an organization’s mission and improvement goals, it may Measure: What is the extent of the problem? Collect baseline implement a process improvement using either the scien- data and determine key measures. tific method or the Define, Measure, Analyze, Improve, Control (DMAIC) process. Analyze: Under what circumstances did the problem occur? Use statistical analysis tools to analyze the data and the process The Scientific Method to determine the root cause(s). The fundamental components of any improvement process are the following: Improve: How can the problem be solved? Develop, evaluate, • Planning the change refine, and implement solutions to the identified problems. • Testing the change • Studying its effects Control: How can the solution be sustained? Document and • Implementing changes determined to be worthwhile monitor improvements and design controls.

Many readers will readily associate the activities listed— Additional RCA Tools plan, test, study, implement—with the scientific method. The following tools are useful for taking action to Indeed, the scientific method is a fundamental, inclusive improve processes: paradigm for change and includes the following six steps: • Brainstorming can be used to create ideas for 1. Determine what is known now (about a process, improvement actions. problem, topic of interest). • Multivoting can help a team decide between possible 2. Decide what needs to be learned, changed, or improved. improvement actions. 3. Develop a hypothesis about the effect of the change. • Flowcharts can help a team understand the current 4. Test the hypothesis. process and how the new or redesigned process 5. Assess the results of the test. (Compare results of the test should work. before state versus the changed state.) • Fishbone diagrams can indicate which changes might 6. Implement successful improvements, or rehypothesize cause the desired result or goal. and conduct another experiment. • Pareto charts can help determine which changes are likely to have the greatest effect in reaching the goal. This orderly, logical, inclusive process for improvement • Control charts and scatter diagrams can measure the serves organizations well as they attempt to assess and effect of a process change or variation in processes improve performance. and outcomes. • Histograms can show how much effect each change has had. 102 CHAPTER 6 | Designing and Implementing a Corrective Action Plan for Improvement

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 3. Develop a vision and strategy that is individually or in some combination as part of a perfor- • Easily pictured mance improvement strategy such as Lean Six Sigma. • Attractive • Feasible and clear Creating and Managing the Change • Flexible Some suggested actions the team might take to help • Communicable manage and lead the change or improvement process follow.12 Based on eight sequential stages in the process of 4. Communicate the changed vision in a way that leading change in organizations,13 the steps in creating and • Is simple managing the change process are as follows: • Uses metaphor 1. Establish a sense of urgency: • Works in multiple forms • Identify the best anywhere and the gap between one • Involves doing instead of telling process and another. • Explains inconsistencies • Identify the consequence of being less than the best. • Involves give and take • Explore sources of complacency. 5. Empower broad-based action: 2. Create a guiding coalition: • Communicate sensible vision to employees. • Find the right people. • Make organization structures compatible with action. • Create trust. • Provide needed training. • Share a common goal. • Align information and human resource systems. • Confront supervisors who undercut change.

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6. Generate short-term wins: • Eliminate unnecessary dependencies. • Fix the date of certain change. • Identify linked subsequent cycles of change. • Do the easy stuff first. • Use measurement to confirm change. 8. Anchor new approaches in the culture: • Results 7. Consolidate gains and produce more change: • Conversation • Identify true interdependencies and smooth • Turnover interconnections. • Succession

Figure 6-4 . DMAIC Model for Root Cause Analysis

Problem Defined

Measure Baseline

Analyze for Root Causes

Why? Cause Why? Cause Why? Cause Cause Investigation Why? Root Why? 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 Effectiveness and Ensure Their Success by the team. Use a separate sheet to plan and monitor the When a function or process is under way, the team should indicators selected to measure each improvement goal. collect data about its performance. As described in Chapter 4, measurement is the process of collecting and aggregating Who should be responsible for measurement? The team, these data, a process that helps assess the level of perfor- empowered to study the process and recommend changes, mance and determine whether further improvement actions is usually responsible for designing and carrying out the are necessary. measurement activities necessary to determine how the process performs. After making changes to improve the The first step in measuring the success of improvement process, the team should continue to apply some or all of efforts is to develop high-quality measures of effectiveness. its measures to determine whether the change has had the The choice of what to measure is critical. Measurement desired effect. Organizations may have various experts who must relate to the improvement and validate the accom- can help design measurement activities, including experts plishment of the goal (or failure to reach the goal). See in information management, quality improvement, risk Checklist 6-4 for key questions the team should ask management, and the function to be measured. The team concerning what to measure. An affirmative answer to the can request such contribution on an ad hoc basis. For questions in the checklist gives the team a good indication example, if the team is investigating a medication error and that it is on the right track with its efforts to measure the has a large amount of data to codify and process regarding effectiveness of improvement initiatives.

Some measures or performance indicators may require TIP specific targets, which should be set by the team prior to Make every effort to coordinate any ongoing data collection. For example, in the patient suicide case measurement with data collection already described previously in Sidebar 3-1, the team should set taking place as part of the organization’s everyday 100% as the target for bringing rooms in the behavioral activities. For example, if nurses are collecting health care unit into compliance with breakaway shower blood pressure data as part of their normal fixtures. For the treatment delay example in the same duties, these same data should be used when assessing the impact of a specific drug on patient sidebar, the team should set a score of 95% as the target for blood pressure. all posttraining test scores.

the administration of a frequently ordered medication, the team may want to seek the help of information manage- Checklist 6-4 . Ensuring the Success of ment staff with access to statistical software capable of Measurement analyzing a large volume of data.

33 Is there a plan for use of the data? Information management professionals and those respon- 33 Are the data collected reliable and valid? sible for carrying out the process being measured are key players in data collection and analysis. The people involved 33 Has ease of data collection been assured? vary widely depending on the specific organization, the 33 Have key elements required for improvement been defined? function being measured, and the measurement process. 33 Has a data rich–information poor syndrome been avoided? STEP 19: Evaluate Implementation of Improvement Efforts 33 Has a key point for information dissemination been designated? After data are collected as part of measurement, they must be translated into information that the team can use to

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make judgments and draw conclusions about the perfor- performance against reference databases, professional stan- mance of improvement efforts. This assessment forms the dards, and trade association guidelines. basis for further actions taken with improvement initiatives. Desired Performance Targets The team can use numerous techniques to assess the data The team may also establish targets, specifications, or collected. Most types of assessment require comparing data thresholds for evaluation against which to compare current to a point of reference. These reference points may include performance, such as professional literature or expert opin- the following: ions within the organization. • Internal comparisons, such as unit-to-unit or time-to-time STEP 20: Take Additional Action • Aggregate external reference databases The team’s assessment of the data collected indicates • Desired performance targets, specifications, or thresholds whether or not it has achieved established targets or goals. If it is achieving the goals, the team’s efforts now should Internal Comparisons focus on communicating, standardizing, and introducing The team can compare its current performance with its past the successful improvement initiatives. The team can do performance using statistical quality control tools. Two such the following: tools are particularly helpful in comparing performance • Communicate the results, as described in subsequent with historical patterns and assessing variation and stability: step 21. control charts and histograms. These tools respectively show • Revise processes and procedures so that the improvement variation in performance and the stability of performance. is realized in everyday work. • Complete necessary training so that all staff members are External References aware of the new process or procedure. In addition to assessing the organization’s own historical • Establish a plan to monitor the improvement’s patterns of performance, the team can compare the orga- ongoing effectiveness. nization’s performance with that of other organizations. • Identify other areas where the improvement could Expanding the scope of comparison helps an organization be implemented. draw conclusions about its own performance and learn about various methods to design and carry out processes. Organizations frequently falter when continued measure- Aggregate external databases come in a variety of forms. ment indicates they are not sustaining improvement goals. Aggregate, risk-adjusted data about specific indicators More often than not, efforts tend to provide short-term help each organization set priorities for improvement by rather than long-term improvement. If the team is not showing whether its current performance falls within the achieving the improvement goals, then it needs to revisit expected range. the improvement actions by circling back to confirm root causes, identify a risk-reduction strategy, design an improve- One method of comparing performance is benchmarking. ment, implement a corrective action plan, and measure the Although a benchmark can be any point of comparison, effectiveness of that plan over time. most often it is a standard of excellence. Benchmarking is the process by which one organization studies the exem- There are a number of reasons a team’s improvements may plary performance of a similar process in another organiza- falter and fail.14 If the team is having trouble effecting tion and, to the greatest extent possible, adapts that infor- improvement, consider the information shown in Table mation for its own use. Or the team may wish to simply 6-2, page 107. compare its results with those of other organizations or with current research or literature. STEP 21: Communicate the Results Throughout the root cause analysis process, the team should Assessment is not confined to information gathered be communicating to the organization’s leadership the team within a single organization. To better understand its conclusions and recommendations as outlined by the team level of performance, an organization should compare its early in the process. Hence, the communication process

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Table 6-2. When Improvements Falter: Sidebar 6-3 . Reasons and Remedies Possible Content of Report to Leaders Human Factors • Failure to hold the gains because the improvement required major changes, particularly behavioral changes Event Description • Failure to hold the gains because the improvement created This section includes a brief description of the sentinel extra work or hassle event or possible event. It includes what, when, where, • Failure to hold the gains because new staff or leadership who, and how information as articulated in the problem personnel were not trained in the improved process definition (see step 2 in Chapter 3, pages 53–57). • Inability to replicate in other settings The emphasis is on facts related to the event and the • Not enough public or personal attention to improvement areas involved. success • Inadequate institutional and administrative support Scope of Analysis • Hidden barriers to needed changes This section describes the team’s membership and • A cookie-cutter approach to replicating improvement 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. Proximate Causes and Immediate Responses • Design improvements so that the desired task is the easiest This section describes the circumstances leading to the thing do. Design a robust process that makes it easy to do event, proximate causes identified by the team, and any things right and difficult to do things incorrectly. response strategies and corrective actions implemented • Ensure continued training of all appropriate staff. by individuals immediately following the event. • 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 Contributing Factors exists), persuasion (forming a favorable attitude toward This section describes the circumstances, actions, or the new idea), decision (choosing to adopt the innovation), influences thought to have played a part in the origin, implementation (putting the idea into use), and confirmation development, or increased risk of an incident. (seeking further verification of the innovation, leading to either continued adoption or discontinuance). Consider and plan for this process when bringing an improvement to Root Causes every setting. This section describes the analyses conducted to deter- • Leaders must ensure that improvement successes are mine root causes and lists the root causes identified by recognized and celebrated. the team. • Leaders must provide time and talent. • Leaders must empower improvement teams to identify Improvement Actions and Follow-Up Plan where changes are needed and help them make the This section describes the improvement actions changes happen. recommended by the team for each root cause. It also • Process improvements must be reinvented at each new site, adapted to meet local circumstances, and fingerprinted describes the measures and time frame recommended by the local owners of the newly improved process. 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 The team should consider with care how and to whom the success of improvement initiatives. report is to be presented. Participants during a formal oral presentation should include those whose approval and help After determining what happened or could have happened is needed as well as those who could gain from the team’s and identifying root causes of the event or possible event, recommendations. Consider the following questions in the team should provide leadership with the recommenda- communicating an improvement initiative: tions for improvement actions to prevent a recurrence of • How will the team communicate the implementation of the event. Generally, a short written report provides leaders this initiative throughout the organization? with the summary they need. An outline of the contents of • Who needs to know? such a report appears as Sidebar 6-3, right. • What communication vehicles will the team use

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Figure 6-5 . Communication Plan Template DOWNLOAD

Project: ______

Message and Goal (for example, memo,e-mail, Audience Message and Goal 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 report should include information regarding applicability to indirectly affected by the improvement)? other processes, areas, and locations and the lessons learned.

The team also needs to ensure that communication about A template for planning the communication strategy for the results will be an ongoing activity that reinforces the the roll out across your organization is included as Figure reasons for the improvement initiative. Storytelling is 6-5, above. an effective strategy when reporting the results to a wide audience at various staff meetings. Storytelling humanizes References the event that caused the root cause analysis, which helps 1. Leape LL. Error in medicine. JAMA. 1994 Dec catch people’s interest and get them emotionally invested in 21;272(23):1851–1857. improvement actions. Storytelling also helps safeguard an 2. Last JM, editor. A Dictionary of Epidemiology, 4th ed. New York: organization against communication leaks. Written reports Oxford University Press, 2001. have a greater tendency than oral accounts do to leak 3. Nash DB, Goldfarb NI. The Quality Solution: The Stakeholder’s outside a facility to media outlets. In some cases this leads Guide to Improving Health Care. Sudbury, MA: Jones and Bartlett, 2006. to the media publicly portraying organizations in the worst 4. Hoffman C, et al. Canadian Root Cause Analysis Framework: possible light by taking incident reports and improvement A Tool for Identifying and Addressing the Root Causes of Critical plans out of context. Incidents in Healthcare. Edmonton, AB: Canadian Patient Safety Institute, 2006. Following implementation of such actions and measuring 5. Keohane C, et al. Intravenous medication safety and smart and ensuring their success, the team should report to infusion systems: Lessons learned and future opportunities. J leadership on the results of the improvement actions. The Infus Nurs. 2005 Sep–Oct;28(5):321–328.

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6. National Patient Safety Foundation. RCA2: Improving Root Cause 11. Schulte SK. Avoiding culture shock: Using behavior change Analyses and Actions to Prevent Harm. Boston, MA: National theory to implement quality improvement programs. J AHIMA. Patient Safety Foundation; 2015. 2007 Apr;78(4):52–56. 7. Hughes D. Root cause analysis: Bridging the gap between ideas 12. Nelson EC, Batalden PB, Ryer JC, editors. Clinical Improvement and execution. Topics in Patient Safety. 2006 Nov–Dec;6(5):1, 4. Action Guide. Oakbrook Terrace, IL: Joint Commission on Accessed July 16, 2017. https://www.patientsafety.va.gov/docs Accreditation of Healthcare Organizations, 1998, pp. 116–117. /TIPS/TIPS_NovDec06.pdf 13. Kotter JP. Leading Change. Boston: Harvard Business School 8. Wilson PF, Dell LD, Anderson GF. Root Cause Analysis: A Tool for Press, 1996. Total Quality Management. Milwaukee: ASQ Quality Press, 1993. 14. James B, Ryer JC. Holding the gains. In Nelson EC, Batalden 9. Ammerman M. The Root Cause Analysis Handbook: A Simplified PB, Ryer JC, editors: Clinical Improvement Action Guide. Approach to Identifying, Correcting, and Reporting Workplace Oakbrook Terrace, IL: Joint Commission on Accreditation of Errors. New York: Productivity Press, 1998. Healthcare Organizations, 1998, 121–124. 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

Learning Objectives What Is Lean Six Sigma? Lean Six Sigma is a term describing an improvement meth- • Better understand the improvement methodologies of Robust Process Improvement® and Lean odology based on the scientific method, statistical methods, Six Sigma customer values, and flow and pull principles. In his book The Machine That Changed the World, James Womack • Become familiar with a variety of analytical tools coined the term Lean to describe the methods of the Toyota and processes, when each is best used, and how best to apply them Production System, in which all employees work together to eliminate waste (of resources and time) and to keep the • Implement these tools as part of a comprehensive process focused on the value of the product to the customer. systematic analysis The term Six Sigma comes from Motorola’s description of its methods for improving quality in a systematic way. It Root cause analysis is a key element in an organization’s refers to a statistical concept in which a process or output efforts toward performance improvement. Numerous remains within six standard deviations of the mean value tools exist within various performance improvement in a normal distribution. Both Toyota and Motorola have methodologies, including Robust Process Improvement® been widely recognized for high quality. For those who (RPI®) and Lean Six Sigma, to facilitate the process of have worked with both companies and have applied their root cause analysis and specific issues of patient safety methods, Lean Six Sigma is an appropriate label because the and quality in health care. Lean and Six Sigma methods are found in both companies and are considered inseparable. What Is RPI? The Joint Commission has created its own organization- DMAIC wide plan of RPI®, a set of strategies, tools, methods, and Lean Six Sigma often is applied in a five-step prob- training programs for improving business processes. This lem-solving approach commonly known by the acronym blended approach uses Lean, Six Sigma (see next section), DMAIC. It is the core of Six Sigma methodology that and Change Management methodologies: describes its problem-solving sequence: • Lean removes waste and increases speed. • Six Sigma reduces deficits and variation in a process and • D, for Define, is a critical first step to have a clear improves quality. understanding of the issue or problem to be solved. • Change Management prepares employees to seek, commit • M stands for Measure, wherein the team assesses the to, and accept change. baseline performance of the process and identifies the potential contributing factors when the process fails to Key components of RPI include building the expertise of meet customer expectations. This step also is essential staff and leadership and embedding tools and methods because without knowing the current state, one cannot into everyday work. The Joint Commission has begun gauge whether the process improved. exporting the RPI methodology by providing training • A is for Analyze, in which the team uses a variety to external organizations through its Center for of analytical and statistical tools to determine the Transforming Healthcare. critical few contributing factors impacting the examined process. 111 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Table 7-1. Tool Matrix • I stands for Improve, and the team will statistically validate that the interventions achieve the results. Implementing • C is for Control to ensure sustained gains. Tool Name (Alternate Identifying Proximate Identifying Improvement Identifying Root Causes and Monitoring Name) Causes Opportunities Improvements (DMAIC is described in greater detail in Chapter 6, pages Affinity diagram X X 102–104.) Earlier problem-solving methodologies often Brainstorming X have shown limited success in creating interventions that Change analysis X X last. The methodologies forwarded by Toyota and Motorola Change management X X thus include key tools to better control the process for long- Check sheet X term success. Control chart X Any employee can learn Lean Six Sigma. One’s level of Failure mode and X effects analysis expertise is often signified by a “belt” designation: Yellow (FMEA) Belt, Green Belt, Black Belt, Master Black Belt, or Sensei, Fishbone diagram X X awarded following training at that level. (Cause-and-effect diagram) Green Belts may be taught basic statistical tools as well as Flowchart X X X X the flow and pull concepts from the Toyota Production Gantt chart X X X X System. Flow (continuous forward movement) in a process Histogram X X X X is desired as a sign that the process quality and productivity Multivoting X X X are higher than a process that repeatedly stops and starts. Operational definition X Pull refers to how the inputs of the process are replenished Pareto chart X X based on the customer’s demand rather than the organiza- tion’s timetable. Relations diagram X X X Run chart X X X This chapter provides information on tools and techniques Scatter diagram X that can be used during root cause analysis. The tools and (Scattergram) techniques appear in a uniform format, a tool profile, to SIPOC process map X assist readers with their selection and use. Each tool profile Stakeholder analysis X identifies the purpose of the tool or technique, the stage of Standard work X root cause analysis during which the tool or technique may Value stream mapping X X X be used, basic usage steps, and tips for effective use. An This matrix lists many of the tools and techniques available during root cause analysis and indicates the stages during which example of the tool or technique follows each profile. they may be particularly helpful. Each tool is described in greater detail in this chapter. 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.

Affinity Diagram (See Figure 7-1)

Purpose: To creatively generate a large volume of ideas or issues and then organize them into meaningful groups

112 CHAPTER 7 | Tools and Techniques

• I stands for Improve, and the team will statistically Stages to Use: Identifying proximate causes, identifying validate that the interventions achieve the results. improvement opportunities • C is for Control to ensure sustained gains. Simple Steps to Success: (DMAIC is described in greater detail in Chapter 6, pages 1. Choose a team. 102–104.) Earlier problem-solving methodologies often 2. Define the issue in the broadest and most neutral manner. have shown limited success in creating interventions that 3. Brainstorm or brainwrite (for example, for contributing last. The methodologies forwarded by Toyota and Motorola factors or for suggested improvements) and record the ideas. thus include key tools to better control the process for long- 4. Randomly display sticky notes with the ideas so that term success. everyone can see them. 5. Sort the ideas into groups of related topics. Any employee can learn Lean Six Sigma. One’s level of 6. Create header or title cards for each grouping. expertise is often signified by a “belt” designation: Yellow 7. Draw the diagram, connecting all header cards with Belt, Green Belt, Black Belt, Master Black Belt, or Sensei, their groupings. 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 Encourage team participation by doing System. Flow (continuous forward movement) in a process the following: is desired as a sign that the process quality and productivity ►► Keep the team small (four to six people) and are higher than a process that repeatedly stops and starts. ensure varied perspectives. Pull refers to how the inputs of the process are replenished ►► Generate as many ideas as possible using based on the customer’s demand rather than the organiza- brainstorming guidelines. tion’s timetable. ►► Record ideas from brainstorming on sticky notes to ensure that all participants have the This chapter provides information on tools and techniques opportunity to share their ideas. that can be used during root cause analysis. The tools and ►► Consider brainwriting, a strategy in which techniques appear in a uniform format, a tool profile, to participants write their ideas, rather than assist readers with their selection and use. Each tool profile delivering them orally, as a strategy to increase identifies the purpose of the tool or technique, the stage of participation and decrease extraneous root cause analysis during which the tool or technique may conversation. be used, basic usage steps, and tips for effective use. An ►► Sort the ideas in silence, being guided in sorting example of the tool or technique follows each profile. only by gut instinct. ►► If an idea keeps getting moved back and forth When embarking on a root cause analysis, team members from one group to another, agree to create a may wish to start by consulting the tool matrix shown duplicate note. in Table 7-1 on page 112. This matrix lists many of the ►► Reach a consensus on how notes are sorted. tools and techniques available during root cause analysis ►► Allow some ideas to stand alone. and indicates the stages during which they may be ►► Make sure that each idea has at least a noun particularly helpful. and a verb when appropriate; avoid using single words. Affinity Diagram ►► Break large groupings into subgroups with (See Figure 7-1) subtitles, but be careful not to slow progress with too much definition. Purpose: To creatively generate a large volume of ideas or issues and then organize them into meaningful groups

113 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 Lab reports not printed until 10:30 AM Intensive care unit and stat orders until 10 AM take precedence

Intensive care unit and telemetry Results available in lab system Too many stat orders when drawn first before until system 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 Labs not placed on front of chart Labs ordered incorrectly preoperative

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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3. Set a time limit. Allow enough time for every member Brainstorming to make a contribution, but keep it short to prevent (See Figure 7-2) premature analysis of ideas. 4. Generate ideas. Use a structured format in which the Purpose: To generate multiple ideas in a minimum amount group members express ideas by taking turns in a of time through a creative group process predetermined order, one idea per turn. The process continues in rotation until either time runs out or ideas Stages to Use: Identifying improvement opportunities are exhausted. 5. Clarify ideas. The goal is to make sure that all ideas are Simple Steps to Success: recorded accurately and are understood by the group. 1. Define the subject. Doing so ensures that the session has direction. Figure 7-2 . Example: Brainstorming List 2. Think briefly about the issue. Allow enough time for team Possible factors contributing to a surgical error may members to gather their thoughts, but not enough time include the following: for detailed analysis. ►► 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. ►► ►► Tell the group up front that any idea is welcome, Inadequate presurgical evaluation no matter how narrow or broad in scope or how ►► No review of patient care information prior serious or light in nature. All ideas are valuable, to surgery as long as they address the subject at hand. ►► Inadequate informed consent ►► Remember that the best ideas are sometimes the most unusual. ►► Patient care information unavailable for ►► Allow group members to occasionally say “pass” preoperative review if they can’t think of an idea when it’s their turn ►► Failure to perform surgery in a safe manner to speak. ►► Laterality not clearly identified ►► Never criticize ideas. It is crucial that neither the leader nor the other group members comment ►► Delay in reporting of incident on any given idea. ►► No multidisciplinary review ►► In thinking briefly about the issue (step 2), do not give group members time to second-guess ►► Ignored pathology reports their ideas. Be aware that self-censorship stifles ►► History of inadequate documentation in creative thought. medical record ►► Write down all ideas on a chalkboard or easel so ►► Procedures performed without adequate expertise that the group can view them. ►► ►► Keep it short; enforce a time limit of 10 to Failure to take responsibility for actions 20 minutes. ►► No surgical plan/preoperative findings ►► In organizations where staff may not regularly This figure shows an excerpt from a list one organization be in a centralized location, brainstorming can be created using brainstorming to identify possible done by asking staff to submit as many ideas as contributing factors in a surgical error that occurred. This possible about the topic in writing, by voice mail, list was used to create the fishbone diagram that appears or by e-mail. as Figure 7-8, page 124. As the example shows, the ►► Make a note of deeper root causes that emerge ideas are widely varied, and some seem more viable than during brainstorming and place them in a “parking others. Remember that brainstorming is for generating ideas, not sorting or judging them. lot” list for consideration later.

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Effective Use Tips Change Analysis (See Figure 7-3; or, a blank template is available in ►► Describe the problem as accurately and in as 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, Purpose: To determine the proximate and root cause(s) of and when it took place. an event by examining the effects of change. This involves ►► After a change analysis is performed, additional identifying all changes, either perceived or observed, and all questions must be asked to determine how the possible factors related to the changes. changes were allowed to happen. ►► Continue the questioning process into the Stages to Use: Identifying proximate causes; identifying organization’s systems. root causes ►► Remember that not all changes create problems; rather, change can be viewed as a force that can Simple Steps to Success: either positively or negatively affect the way a 1. Identify the problem, situation, or sentinel event. system, process, or individual functions. 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 identify possible underlying causes. Describe how and how information listed in step 1. these affected the event. Did each difference or change 3. Compare the two. Take a close look at the event and explain the result? nonevent descriptions, and try to detect how these 6. Integrate information and specify root cause(s). Identify situations differ. the cause that, if eliminated, would have led to a 4. List all the differences. nonevent situation. 5. Analyze the differences. Carefully assess the differences

Figure 7-3 . Change Analysis Worksheet

Event Nonevent Differences Analysis Who was involved? What was the expected or What differences are What is the underlying cause What conditions may have desired series of events and/ apparent? of the variation? contributed? or outcome? When and where did the event take place?

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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Effective Use Tips Change Management (See Figure 7-4) ►► Engage the right people early in your initiative to help you build a base of support and identify Purpose: To encourage organizational acceptance of a points where there may be resistance to change. 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. 5. Seek input from staff members in designing the change. 2. Secure leadership buy-in. 6. Implement the change. 3. Anticipate resistance to change from staff who will be 7. Gauge the effectiveness of the change. affected by the change. 8. Modify the change, if necessary, to reach the 4. Communicate a vision of the improvement that will result desired result. from the change. 9. Maintain support for the change.

FacilitatingFigure Change7-4 . Change Model Management

Launch Support Plan Your Inspire the the Project People Initiative Change

Facilitating Change

1

Plan Your Project Inspire People Launch the Initiative Support the Change ►► Assess the culture. ►► Make it personal. ►► Align operations and ►► Permeate the culture. infrastructure. ►► Define the change. ►► Solicit support and ►► Monitor progress. involvement. ►► Get the word out. ►► Assemble a strategy. ►► Sustain the gains. ►► Look for resistance. ►► Engage the right people. ►► Lead change. ►► Brainstorm barriers to 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.

117 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Effective Use Tips Check Sheet (See Figure 7-5; or, a blank check sheet is ►► Determine which data matter for your purpose ­available in the e-book DOWNLOAD or on the and include that on the check sheet. flash drive.) ►► Use the data recorded on the check sheet to create a control chart, histogram, or bar chart for Purpose: To sort and group data, using hatch marks further analysis. or similar symbols, onto a form that can be used with ►► Investigate findings of process variations, and other tools 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. Simple Steps to Success: 3. Train data collectors in the data definitions and use of 1. Determine what data are to be collected and develop the form. operational definitions. Decide when data collection will 4. Have team members record the data by placing a check start and end. mark, hatch mark, X, or other symbol next to the 2. Design a simple form labeling rows and columns appropriate value each time the targeted event or representing the appropriate values. For example, each problem occurs.

Figure 7-5 . Example: Check Sheet

Interruptions to Medication Administration Preparation

Reason Day Mon Tue Wed Thu Fri Total Info request |||| || | |||| |||| || 20

Patient call || || || || || 10 light

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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Effective Use Tips Control Chart (See Figure 7-6) ►► Obtain data before making any adjustments to the process. Purpose: To identify the type of variation in a process and ►► In plotting data points, keep the data in a logical whether the process is statistically in control time-ordered sequence. ►► Be aware that special causes of variation, Stages to Use: Implementing and monitoring or causes not inherently present in systems, improvements must be eliminated before the process can be fundamentally improved and before the control Simple Steps to Success: chart can be used as a monitoring tool. ►► The terms in control and out of control do not 1. Choose a process to evaluate, and obtain a data set. signify whether a process meets the desired level 2. Calculate the average. of performance. A process may be in control 3. Calculate the standard deviation. The standard deviation but consistently poor in terms of quality, and the is a measure of the data set’s variability. reverse may be true. 4. Set upper and lower control limits. Typically these are set ►► Charting something accomplishes nothing; it by multiplying the standard deviation by 3 and then must be followed by investigation and adding/subtracting that from the mean. appropriate action. 5. Create the control chart. In creating the control chart, ►► Processes as a rule are not static. Any change plot the mean (that is, center line) and the upper and can alter the process distribution and should lower control limits. trigger recalculation of control limits when the process change is permanently maintained and TIP sustained (that is, greater than 8 to 12 points on one side of the process mean, or center line). ►► Some special causes of variation are planned Calculating Standard Deviation changes to improve the process. If the special Standard deviation is a measure of the variability cause is moving in the right direction toward of a set of numbers, or data set. Some spreadsheet improvement, retain the plan. It is working. software will calculate the standard deviation for you, but if you need to calculate the standard ►► Use the following four rules to identify out-of- deviation for your data set on your own, follow control processes: these steps: 1. One point on the chart is beyond three stan- 1. Calculate the mean by adding all the members dard deviations of the mean. in your data set together and dividing the sum 2. Two of three consecutive data points are on by the number of members in your data set. 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 3. Four of five consecutive data points are on the the mean from each number in your data set. same side of the mean and are beyond one standard deviation of the mean. 3. Then square each of the results to make them 4. Eight data points are on one side of the mean. all positive numbers.

4. Calculate the mean of these squared numbers by adding them together and dividing by the 6. Plot the data points for each point in time, and connect number of numbers. The resulting number is them with a line. called the variance. 7. Analyze the chart and investigate findings including paying particular attention to any points that lie outside of the 5. Finally, take the square root of the variance in control limits. order to cancel out the squaring in step 3. This is the standard deviation of your data set.

119 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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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, relative to frequency of occurrence, severity, and an FMEA template is available in the e-book likelihood of detection. DOWNLOAD or on the flash drive.) ►► Risk priority numbers (RPNs) may be calculated as a simple product: multiply the ratings for severity of effect by likelihood of occurrence by Purpose: To examine a prospective design for possible ways ability to detect. in which failure can occur so that actions can be taken to ►► Remember that this type of analysis is generally eliminate the possibility of failure, stop a failure before it proactive (used before an adverse event occurs), reaches people, or minimize the consequences of a failure although use during root cause analyses to formulate and evaluate improvement actions is Stage to Use: Identifying opportunities for improvement also recommended and described in this book in Chapter 6 on pages 86–92. Simple Steps to Success: ►► Ideally, assign an FMEA facilitator with FMEA 1. Select a high-risk process and assemble a team. Pick a experience who is not a direct supervisor, as process that is narrow in scope and supported by data or the presence of a supervisor may inhibit a frank staff feedback that suggest a high potential failure rate. discussion of process failures. Team members 2. Diagram the process. Develop either a flowchart or should be drawn from all departments that the process involves and include those who detailed process flow (outline format) of the process participate directly in the process and have under analysis. first-hand knowledge of how it actually operates 3. Brainstorm potential failure modes. For each step in during daily work. the process, brainstorm or brainwrite a list of things ►► Explain the FMEA methodology to the team that could possibly go wrong. These are your potential and emphasize that it is intended as a proactive “failure modes.” measure to identify and correct or mitigate 4. Prioritize failure modes (often accomplished through potential failures, not to expose wrongdoing or calculating a risk priority number or RPN, see Figure incompetence by staff. A thorough explanation 7-7). Determine the effects of the failure modes and of the process will help build trust and a sense determine the most frequent and potentially most severe. that the organization will follow through with improvement projects. 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 8. Implement and monitor the redesigned process. If problem to occur). performance data must be collected that is not already 6. Redesign the process. Develop a plan addressing how the being collected by the organization, designate what root causes and contributing factors of selected failure data will be collected, how, and by whom. Monitor modes will be addressed, by whom, when, how the performance in the selected process to determine if the improvement will be assessed, and so forth. changes are having the desired effect. 7. Analyze and test the new process.

121 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Figure 7-7 . FMEA Rating Scale

Rating Severity of Effect Rating Likelihood of Occurrence Rating Ability to Detect 10 Hazardous without warning 10 10 Cannot detect Very High: Failure Almost 9 Hazardous with warning 9 Inevitable 9 Very remote chance of detection

8 Loss of primary function 8 8 Remote chance of detection

High: Repeated Failures 7 Reduced primary function 7 7 Very low chance of detection performance 6 Loss of secondary function 6 6 Lower chance of detection

5 Reduced secondary function 5 5 Moderate chance of performance Moderate: Occasional Failures detection 4 Minor defect noticed by most 4 4 Moderately high chance of customers detection 3 Minor defect noticed by 3 3 High chance of detection some customers Low: Relatively Few Failures 2 Minor defect noticed by 2 2 Very high chance of discerning customers detection 1 No effect 1 Remote: Failure is Unlikely 1 Almost certain detection

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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Effective Use Tips Fishbone Diagram (Synonym: cause-and-effect diagram) ►► Make sure everyone agrees on the problem (See Figure 7-8) statement or outcome. ►► Be succinct and stay within the team’s realm Purpose: To present a clear picture of the many causal rela- of control. tionships between outcomes and the contributing factors in ►► Gather data to determine the relative frequencies those outcomes of the causes. ►► Look for causes that appear continually in the Stages to Use: Identifying proximate causes; identifying evaluation process. 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, 3. Brainstorm all the possible proximate and underlying causes halfway down, with a horizontal line extending from it under each general category. across the page. 4. List proximate (or apparent) causes under each general 2. Determine general or common categories of the problem category, each with its own subsequent rib. (which could be as generic as methods, staffing, training, 5. List underlying (or latent) causes related under each environment, and so forth). Draw “ribs” extending proximate cause. vertically from the horizontal line, or “spine” and label 6. Evaluate the diagram. each rib with a general category.

123 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Figure 7-8 . Example: Fishbone Diagram

PATIENT PERSONNEL

Medical condition Lack of Education Denial of suicide ideation • History alcohol abuse • Depression assessment education • No history of prior inadequate psychiatric hospitalization • DTs (delirum tremens) Inadequate Staff • Orientation procedures (content, • “No Suicide” contract • Recent alcohol timeliness) signed consumption (24 hr) • Cost • Availability • 15-minute checks • Psychosis trigger Admit Status • Unassertive supervision • Attrition • EDO (emergency detention • Unavailability of staff order)

• 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 • “No Suicide” contract Admission Procedure • Grab bar 33” from floor not • Psychiatric evaluation • Communication with case manager not performed not thorough previously determined to Hazard Rounds be hazard • Written/verbal report incomplete • By persons unfamiliar with • Inadequate orientation with community • Direct observation of patient psychiatric needs mental health state • No visualization of • Assignment of personnel bed areas Observation Status Inadequate • Lack of education • Patient denied • Physical layout • Patient not seen by psychiatrist upon admit • Lack of criteria Multiple Admissions • Not an open dorm • Personnel not following procedure • Access not • Time of day restricted • Only provider • Inadequate assessment by staff

ENVIRONMENT 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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Effective Use Tips Flowchart (See Figure 7-9) ►► Ensure that the flowchart is constructed by the individuals actually performing the work Purpose: To help teams understand all steps in a process being charted. through the use of common, easily recognizable symbols, ►► Be sure to examine a process within a system, illustrating the actual path a process takes or the ideal path rather than the system itself. it should follow ►► If the process seems daunting and confusing, create a simple high-level flowchart containing only the most basic components. Do not include Stages to Use: Identifying proximate causes; identifying too much detail; be wary of obscuring the basic root causes; identifying opportunities for improvement; process with too many minor components. implementing and monitoring improvements ►► Use adhesive notes placed on a wall to experiment with sequence until the appropriate Simple Steps to Success: one is determined. Define the process to be charted, and establish starting and 1. ►► Make the chart the basis for designing an ending points of the process. improved process, using spots where the process 2. Brainstorm activities and decision points in the process. works well as models for improvement. Look for specific activities and decisions necessary to ►► Create a separate flowchart that represents the keep the process moving to its conclusion. ideal path of the process, and then compare the 3. Determine the sequence of activities and decision points. two charts for discrepancies. 4. Use the information to create the flowchart. Place each ►► Keep in mind that difficulties probably reflect activity in a box, and place each decision point in confusion in the process being charted, and work a diamond. Connect these with lines and arrows to through them. indicate the flow of the process. 5. Analyze the flowchart. Look for unnecessary steps and redundancies, and any other difficulties.

125 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Figure 7-9 . Example: Medication Administration Flowchart

Prescriber writes order

Is order No Order is entered Pharmacy receives understandable Call perscriber to Prescriber clarifies into computer computerized and compatible verify order or changes order system order with patient’s record?

Yes

Pharmacy fills order

Order arrives on unit

Is the No medication Call physician to Call pharmacist to correct? verify correctness verify correctness Does it match of order of medication 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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Effective Use Tips Gantt Chart (See Figure 7-10) ►► Leave enough space in the time line to write beneath each time period. Purpose: To graphically depict the time line for long-term ►► Write entries in a stair-step fashion, each step and complex projects, enabling a team to gauge its progress below the one before it, so that overlapping steps and track its schedule are clearly indicated. ►► Color in the rectangles as each step is completed. Stages to Use: Identifying proximate causes; identifying ►► If the project is very complex and lengthy, root causes; identifying opportunities for improvement; consider creating a Gantt chart for each phase or implementing and monitoring improvements each quarter of the year.

Simple Steps to Success: 4. Indicate on the vertical axis where the steps fall. Each step 1. Identify the major steps or processes involved in the project should be plotted in relation to the projected time line using a flowchart or other tool. Also identify the sequence that appears above, in a bar that spans the appropriate of events and any interdependencies or milestones. length of time needed to complete the step beginning 2. Agree on start and stop dates for the project and its and ending at the time frames identified in step 2. major steps. 5. Chart the progress of each process step. 3. Draw a time line on a horizontal axis using days or weeks, 6. Observe the progress and determine if changes should be depending on the scale most appropriate for your plan. made to either the process or the timeline to successfully meet project requirements.

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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Histogram Effective Use Tips (See Figure 7-11) ►► Data should be variable (that is, measured on Purpose: To provide a snapshot of the way data are a continuous scale such as temperature, time, distributed within a range of values and the amount of weight, speed, and so forth). variation within a given process, suggesting where to focus ►► Make sure data are representative of typical and improvement efforts current conditions. ►► Use more than 50 data points to ensure the Stages to Use: Identifying proximate causes; identifying emergence of meaningful patterns. root causes; identifying opportunities for improvement; ►► Be sure that the classes are mutually exclusive implementing and monitoring improvements so that each data point fits into only one class. ►► Using class intervals of 10 units makes for easier Simple Steps to Success: mental calculations. 1. Obtain the data sets, and count the number of data points. ►► Be aware that the number of intervals can (You need at least 50 consecutive data points.) influence the pattern of the sample. 2. Determine the range for the entire data set by subtracting ►► Be suspicious of the accuracy of the data if the the smallest value from the largest value. histogram suddenly stops at one point without some previous decline in the data. 3. Set the number of classes (or bars) into which the data will be divided. ►► The shape of a histogram reflects the statistical mean and median. If the histogram is skewed 4. Determine the class width by dividing the total range of right, the mean is greater than the median. If the the data by the number of classes. Use your judgment to histogram is close to symmetric (that is, the data adjust the width to a convenient number, but it must are roughly the same in height and location on not have more decimal places than the numbers you are either side), then the mean and median are close graphing. to each other. If the histogram is skewed left, the 5. Establish class boundaries (or edges). Choose a convenient mean is less than the median. number to be the lower edge of the first bar, lower than ►► Remember that some processes are naturally any of the data values. skewed; do not expect a normal pattern 6. Construct the histogram. Place the values for the classes on every time. the horizontal axis and the frequency on the vertical axis. ►► Large variability or skewed distribution may signal 7. Count the data points in each class, and create the bars. that the process requires further attention. Keep adding the class width to find the lower edge of ►► Take time to think of alternative explanations for each successive bar. the patterns seen in the histogram. 8. Analyze the findings.

Figure 7-11 . Example: Histogram 50

40

30

20

10

Number of Occurrences in Third Quarter 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. 128 CHAPTER 7 | Tools and Techniques

Effective Use Tips Multivoting (See Figure 7-12) ►► Ensure that when combining ideas on the lists, the team members who suggested the ideas Purpose: To narrow down a broad list of ideas (that is, agree with the new wording. more than 10) to those that are most important and worthy ►► Clearly define each idea so that it is easily of immediate attention understood by everyone voting. ►► Dot voting, a variation of multivoting, involves Stages to Use: Identifying proximate causes; identifying writing the choices on sticky notes or paper stuck to a wall and giving each team member a root causes; identifying opportunities for improvement number of colored stickers to distribute among the listed options. Simple Steps to Success: 1. Using a brainstorming list or other list, combine any items on the list that are the same or similar. 3. Allow time for group members to assign their 2. Determine the number of points each group member can individual points. assign to the list and whether you will use a “passion 4. Tally the votes. vote,” that is, allowing each member to have one vote 5. Note items with the greatest number of points. that is weighted more heavily (typically 3 to 5 points). 6. Choose the final group, or multivote again. Each member uses a predetermined number of points (typically between 5 and 10) to vote on the items on the list.

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.

129 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Effective Use Tips Operational Definition (See Figure 7-13) ►► Be as concise as possible. ►► If the definition has no numbers in it, it may Purpose: To remove ambiguity so that everyone has the not be specific enough and could possibly be same understanding of the issue being defined further revised.

Stages to Use: Identifying improvement opportunities 2. Determine the particular means of measurement that would be appropriate in supporting the definition. Simple Steps to Success: 3. Write the definition, including the specific, concrete 1. Consider what is to be defined. It may be a project charter, measurement criteria to be used in determining whether a customer requirement, or an aspect of data collection. the terms of the definition have been met.

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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Effective Use Tips Pareto Chart (See Figure 7-14) ►► If the team is working from a fishbone diagram, the topic is the effect that has been targeted for Purpose: To show which events or causes are most frequent improvement. (See the Fishbone Diagram tool profile, pages 123–124.) 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 Stages to Use: Identifying root causes; identifying oppor­ diagram, and use the most specific causes and tunities for improvement factors possible. ►► Be sure to mark the chart clearly to show the Simple Steps to Success: standard of measurement. Decide on a topic of study 1. . The topic can be any ►► When analyzing the chart, keep in mind that outcome for which several potential causes have numbers do not always tell the whole story. been identified. Sometimes two severe complaints deserve more 2. Select causes or conditions to be compared. Identify the attention than 100 minor complaints. factors that contribute to the outcome—the more specific, the better. 3. Set the standard for comparison. In many cases, the 7. List factors along the horizontal axis. Factors should be standard is frequency, although factors may be arranged in descending order, with the highest-ranking compared based on their cost or quantity. factor at the far left. 4. Collect data. Determine how often each factor occurs 8. Draw a bar for each factor. The bars represent how (or the cost or quantity of each, as appropriate). Use a often each factor occurs, the cost of each factor, or its checklist to help with this task. quantity, as applicable. 5. Make the comparison. Based on the data collected in the 9. Include additional features, if desired. By making a previous step, compare the factors and rank them from few simple additions to the chart, a team can show most to least. the cumulative frequency, cost, or quantity of the 6. Draw the chart’s vertical axis. On the left side of the categories in percentages. chart, draw a vertical line and mark the standard of 10. Add up the percentages. All the percentages for the measurement in increments. causes need to add up to 100%.

131 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Figure 7-14 . Example: Pareto Chart

90%

120

80%

100 70%

60% 80

50%

60 40% Frequency of Responses

30% 40

20%

20

10%

0 0% reports actions incident consent dictation expertise to surgery evaluation Failure to take documentation responsibility for No surgical plan/ in a safe manner without adequate Delay in reporting Ignored pathology Untimely operative No review of patient Inadequate informed preoperative findings care information prior History of inadequate Performed procedures Inadequate presurgical Failure to perform surgery

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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Effective Use Tips Relations Diagram (See Figure 7-15) ►► Have team members take turns placing ideas on the paper so that everyone participates. Purpose: To generate understanding of how various aspects ►► Remembering the rules for brainstorming, do not of a problem are connected, including cause-and-effect criticize any ideas. relationships ►► 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 Simple Steps to Success: pointing from A to B. Origination notes will indicate 1. Write a definition of the issue (for example, a problem to possible causes, destination notes possible effects. be solved or a solution to be achieved) on a sticky note Ultimately each note will have one or more arrows and put it at the top of a large sheet of paper such as a leading toward and/or away from it. flipchart page on an easel. 5. For each note, count the number of arrows to and from it, 2. Give each member of the group a pad of sticky notes and and write the totals beside each note. For example, three then brainstorm for ideas about the issue, writing down arrows to and one arrow from could be written as “3/1.” one idea per note. 6. Examine the totals. Notes with the highest totals will 3. One at a time, put each idea on the paper. As an idea is be the most important ideas to address in resolving the added, discuss whether it seems related to any other issue. Those with the highest number of arrows out ideas already on the paper; if so, place it nearby (but not represent proximate or possibly even root causes; those touching; there should be space between the notes). with the highest number of arrows in represent the main 4. Determine what the relationships are between related ideas effects. Circle these ideas for further analysis.

133 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’ Emergency pay level appointments

0 in 3 out 3 in 1 out

Equipment Administrative quality and reliability workload

Support functions Changes in availability 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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Effective Use Tips Run Chart (See Figure 7-16) ►► Be sure that the units and scale used in the chart present an accurate picture of the variation Purpose: To provide an overview of the variation in the in order to avoid creating a distorted picture of the problem. 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 moni- ►► Interview the responsible staff members to determine the actual cause of excessive variation. toring improvements ►► Repeat the process and compare performance Simple Steps to Success: and levels of variation on an ongoing basis. 1. Select appropriate units by which to measure variation. This will be your vertical or y-axis. 4. Plot variation on the vertical axis along the horizontal time 2. Select appropriate units of time over which to measure the line in the sequence in which it was collected. variation. This will be your horizontal orx -axis. 5. Calculate the mean or median (whichever the data set 3. Gather the data—a minimum of 10 data points. 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

130

125

120 Minutes 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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Effective Use Tips Scatter Diagram (Synonym: scattergram) ►► A scatter diagram can be used when trying to (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 Purpose: To display the correlation—not necessarily the or using a tool such as a fishbone diagram, when cause-and-effect relationship—between two variables determining whether two effects that appear to be related both occur with the same cause, or when Stages to Use: Implementing and monitoring testing for autocorrelation before constructing a improvements control chart. ►► Select two variables with a suspected relationship Simple Steps to Success: (for example, delays in processing tests and total 1. Decide which two variables are to be tested. volume of tests to be processed). 2. Gather and record paired samples of each of the variables ►► Use the horizontal (x) axis for the variable you on a data sheet. suspect is the cause and the vertical (y) axis for 3. Draw the horizontal (the independent variable) and the effect. vertical axis (the dependent variable). ►► Construct the graph so that values increase while 4. Plot the variables on the graph along the horizontal axis moving up and to the right of each axis. and the vertical axis. If a value is repeated, circle that ►► The more the clusters form a straight line (which point as many times as necessary. could be diagonal), the stronger the relationship 5. Look at the pattern of points for a relationship. Interpret between the two variables. the completed diagram and identify the correlation, ►► If points cluster in an area running from lower left or relationship, between the two variables. If the data to upper right, the two variables have a positive correlation. This means that an increase in y may clearly form a line or a curve, it strongly indicates depend on an increase in x; if you can control x, a correlation. If they don’t, further regression or you have a good chance of controlling y. correlation analysis is needed. ►► 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-and- effect 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 CHAPTER 7 | Tools and Techniques Example: Scatter . Example: Diagram Figure 7-17 Figure This scatter diagram compares two variables associated with self-administration errors—the number of medications prescribed and the ages As might be expected, the clustering of points shows that older patient, higher number medications involved in care. patients involved.

137 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Effective Use Tips SIPOC Process Map (See Figure 7-18; or, a SIPOC template is available ►► Use a cross-functional team to create the SIPOC in the e-book DOWNLOAD or on the flash drive.) process map. ►► Follow one of the key rules of brainstorming Purpose: To identify the basic elements or variables in while going through the steps to create the a process among suppliers, inputs, process, outputs, and SIPOC process map: Allow ideas to be expressed without judgment or critique. customers (SIPOC)

Stages to Use: Identifying improvement opportunities internal (another department in the organization) or external (patients). Simple Steps to Success: 5. Identify and list the inputs—that is, the information, 1. Create a table with five columns labeled suppliers, inputs, materials, or personnel—needed for the process to produce process, outputs, and customers. the outputs. 2. List four or five steps in the process column (center) of the 6. Identify and list the suppliers of the inputs—that is, SIPOC process map. the individuals or organizational groups that provide 3. Identify and list the outputs—that is, the products or the inputs. services being offered to the customers—that result from 7. If needed, make further refinements, for example, by this process. rewording, combining, or moving the items listed within 4. Identify and list the customers—that is, the people who each column. 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 Input Process Step Output Customer

Patient Admitting physician Patient Clinical information Attending physician(s) Confirm existing insulin order set Orders for patient care Attending physician(s) Insulin order set EMR Nurse(s) Nurse(s) Patient Lab Attending physician(s) Testing sample Testing device Testing device Testing device Test patient blood glucose level Testing sample EMR Nurse(s) Target range Nurse Tech Tech Attending physician Insulin Administered insulin dose Nurse(s) Insulin dosing level Administer appropriate dose of insulin Patient Blood glucose change Pharmacy Order set Dietary Standing orders Nurse(s) Confirm patient receives appropriate meal Patient meal Patient Meal Tech Patient Dietary Blood glucose change Patient meal Meal consumed by patient Patient Nurse(s) Completed meal Tech Patient Blood glucose readings Attending physician Standing orders Administered insulin dose Nurse(s) Insulin order set Correctional insulin dosing as necessary Patient Blood glucose change Pharmacy Testing device Tech Target range

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 (See Figure 7-19; or, a stakeholder analysis ►► Consider stakeholders at all levels, including both template is available in the e-book DOWNLOAD or salaried and hourly employees. on the flash drive.) ►► If employees involved in the project are unionized, meet with the union representative to explain the Purpose: To gauge the level of support from key people purpose of the project. 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. Simple Steps to Success: Another possible type of scale uses zero (0) as a midpoint, representing neutral feelings about the 1. Obtain a project charter. project. A positive 1 or 2 (+1, +2) indicates mild or 2. Based on the project charter, identify potential strong support, respectively, while a negative 1 or stakeholders—that is, individuals who play a role in the 2 (-1, -2) represents mild or strong resistance. project. Create a grid with column headings on the left ►► Using the 1-to-10 scale, if the gap number is side for the names and roles of these stakeholders. (Also 0, then the interests of the given stakeholder allow space in the grid for at least three columns on the are perfectly aligned with the objectives of the right side, to be filled in during subsequent steps.) Row process—congratulations! But more likely, the by row, enter the name and role of each stakeholder. number will be greater than 0. 3. Through focus groups or interviews, determine the level of support (also known as buy-in) that each stakeholder shows the number in the column from step 4 and place it for the project. Assign numerical values to reflect each in the third of the right-side columns. The higher the person’s level of support. In the first of the right-side number, the greater the discrepancy between support columns, fill in the level of support shown. needed and support shown. 4. Determine the level of support needed from each 6. Develop a corrective action plan if needed to increase stakeholder for the project to succeed. Assign numerical the level of support based on the stakeholder analysis. values, using the same scale as in the previous step, and An optional column (shown at the far right in Figure place them in the second of the right-side columns. 7-19) may be added to the grid to indicate the strategy 5. Calculate the “gap” between actual and needed support. called for. Subtract the number in the columns from step 3 from

139 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition Example: Stakeholder Analysis Stakeholder . Example: Figure 7-19 Figure The stakeholder analysis chart above lists the stakeholders in relevant improvement project, along with their At the far right perceived level of buy-in to the project, needed for success, and gap between. the project owner has listed strategies for closing buy-in gap each stakeholder.

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Effective Use Tips Standard Work (See Figure 7-20; or, a standard work template ►► Identify individuals who need to be involved. is available in the e-book DOWNLOAD or on the ►► Strive for balance in the work required by flash drive.) each individual. ►► Encourage those involved to think of standard Purpose: To create a logical work flow with a minimum work as “the right way—every time.” of waste ►► Determine necessary tools and information required. Stages to Use: Implementing and monitoring ►► Decide how long the process should take. improvements ►► Identify expected results. ►► Don’t mistake work instructions with standard Simple Steps to Success: operating procedures. Simply put, procedures 1. Document the existing process steps for each tell you who does what and when, whereas work individual involved. instructions tell you how to do something. 2. Identify which steps are waste—that is, they are of no value to the patient. 6. Implement changes in the process to reflect the 3. Measure takt time (the rate of patient demand) and optimum sequence. cycle time (the time it takes to complete one cycle of 7. Monitor the revised process and measure for success. an operation). 8. If the changes are deemed successful, standardize the 4. Determine the optimum sequence of work steps for each new process. individual involved in the process. 5. Create a standardized work chart and use it to train staff to follow the improved process.

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Revision Date: Recorded By: at this station. Add picture(s) that assist layout or finished service with build – pictures used can show entire operation Operation Layout Date: ♦ Dept . /Unit: Time ◆ Quality Check Cycle Time: Option ▼ Key . Example: Standard Work Takt Time: Takt Check Critical Step + Figure 7-20 Figure Key Safety Step • Notes Standard Work Standard Work in Process Key: Process Steps 1 2 3 4 5 6 7 8 9 11 10 12 13 14 15 16 17 18 19 20 21 Step Process Name: The above worksheet can be used to create a logical work flow with minimum of waste.

142 CHAPTER 7 | Tools and Techniques

Effective Use Tips Value Stream Mapping (See Figure 7-21) ►► Make sure the team understands the goal (for example, reduce cycle time, reduce resources, Purpose: To help health care organizations operate success- reduce waste, design for better quality and productivity). fully by eliminating, or at least minimizing activities that do not add value—that is, any steps in a process that do not ►► Keep the focus on the patient in any attempt to discern the value of a step in the process. contribute to a patient’s experience of value ►► Keep the value stream practical—map at the highest level possible. Stages to Use: Identifying proximate causes; identifying opportunities for improvement; implementing and moni- ►► Choose and use the correct tools. toring improvements ►► Provide advanced education to leaders. ►► Explain the purpose of the walk-through to unit, Simple Steps to Success: section, or department staff. 1. Break down and analyze the entire value chain to calculate ►► Communicate progress and results throughout the value delivered by each process area, as perceived by the organization. the patient. This task involves having a cross-functional team literally walk through each step of the process, ultimately improve lead times and eliminate “bullwhip” talking with workers in the value stream and taking effects, creating maximum efficiency and productivity. measurements of the time it takes to do the work and 4. After establishing the true value stream, deliver services in the time spent waiting for the next step. alignment with actual patient demand (that is, “pulled” 2. Map the various steps in their respective places according along by the patient according to the patient’s timetable to value delivered. Consider those areas that do not of need) and not by assumptions or arbitrary forecasts contribute value waste and either minimize or eliminate (that is, “pushed” onto the patient by the organization them. The remaining elements form the foundation for on a timetable set by the organization). developing a true patient-centric value chain. 5. Apply the principle of continuous improvement to the 3. Create a smooth and efficient process flow between the initiative. Ongoing process improvement is absolutely value-added steps identified to transform the chain into a key to sustaining a competitive edge. value stream for the organization. The increase in flow will

143 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition CT=5 minutes Receives Results 4 days + 65 minutes Non value-added time 20 minutes of value- added time 4 days 4 days Wait for Results Wait Patient to lab to ship sample Prepare 5 minutes An organization can CT=5 minutes Draw Sample 5 minutes Lab tells patient appointment time 5 minutes Wait for Phlebotomist Wait 5 minutes Example: Value Stream Mapping Value . Example: Lab scheduling Verify Test Test Verify to Perform Physician calls patient with results CT=5 minutes Figure 7-21 Figure

15 minutes Tells lab time for for time lab Tells

15 minutes patient's appointment patient's Value Stream Map of Patient Driving to Lab and Waiting on Lab Result – Current State Stream Map of Patient Driving to Lab and Waiting Value Wait for Phlebotomist Wait for patient Requests lab test 5 minutes Check In CT=5 minutes

Lab Physician 10 minutes Wait for Receptionist Wait 35 minutes drive to lab + 10 minutes wait to check in This figure shows the current state of a process (a patient driving to lab and waiting on result). experience. use this to identify and eliminate or minimize activities that do not offer value a patient’s

144 Appendix

Framework for Root Cause Analysis Unexpected findings may emerge during the course of the and Corrective Actions* analysis, or there may be some questions that do not apply The Joint Commission’s Framework for Root Cause in every situation. For each finding continue to ask “Why?” Analysis and Corrective Action Plan provides an example of and drill down further to uncover why parts of the process a comprehensive systematic analysis. The framework and its occurred or didn’t occur when they should have. Significant 24 analysis questions are intended to provide a template for findings that are not identified as root causes themselves analyzing an event and an aid in organizing the steps and have “roots.” “Corrective Actions” should be developed for information in a root cause analysis. (A template for this every identified root cause. 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 An organization can use this template to conduct a root provided here in the following tables: cause analysis or even as a worksheet in preparation of • From the Root Cause Analysis section: submitting an analysis through the online form on its –– Root Cause Types: Table A-1 (column 1) Joint Commission Connect™ extranet site. Fully consider –– Causal Factors/Root Cause Details: Table A-1 all possibilities and questions in seeking “root cause(s)” (column 2) and opportunities for corrective actions. Be sure to enter a • From the Corrective Actions section: response in the “Analysis Findings” column for each item. –– Action Strength: Table A-2 * Disclaimer: The framework found on Joint Commission Connect™ will –– Measure of Success: Table A-3 show the most current iteration of this form. –– Sample Size: Table A-4

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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 Prompts Analysis Findings Root Cause Causal Questions Types Factors/ (Table A-1) Root Cause Details (Table A-1) 1 What was List the relevant process steps as the intended defined by the policy, procedure, process flow? 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 Explain in detail any deviation from steps in the the intended processes listed in process that Analysis Question #1 above. did not occur as intended? 3 What human Discuss staff-related human factors were performance factors that contributed relevant to the to the event. outcome? 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

continued

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ROOT CAUSE ANALYSIS continued # Analysis Prompts Analysis Findings Root Cause Causal Questions Types Factors/ (Table A-1) Root Cause Details (Table A-1) 4 How did the Consider all medical equipment and equipment devices used in the course of patient performance affect care, including automated external the outcome? 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 What environmental factors within environmental the organization’s control affected the factors affected the outcome? Examples may include, but outcome? 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 Identify any factors the health uncontrollable care organization cannot change external factors that contributed to a breakdown in influenced the the internal process, for example outcome? natural disasters. 7 Were there any List any other factors not other factors that yet discussed. directly influenced this outcome? 8 What are the other List all other areas in which areas in the health the potential exists for similar care organization circumstances. For example: where this could • Inpatient surgery/outpatient happen? 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.

148 Appendix

ROOT CAUSE ANALYSIS continued # Analysis Prompts Analysis Findings Root Cause Causal Questions Types Factors/ (Table A-1) Root Cause Details (Table A-1) 9 Was staff Include information on the following properly qualified for all staff and providers involved in and currently the event. Comment on the processes competent for their in place to ensure staff is competent responsibilities? 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 Include ideal staffing ratios and actual staffing compare staffing ratios along with unit census with ideal level? 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 Include information on what the plan for dealing health care organization does during with staffing a staffing crisis, such as call-ins, contingencies? 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 If alternative staff were used, contingencies describe their orientation to the a factor in this area, verification of competency, and event? environmental familiarity.

13 Did staff Describe whether staff performed performance as expected within or outside of during the the processes. To what extent was event meet leadership aware of any performance expectations? 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.

continued

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ROOT CAUSE ANALYSIS continued # Analysis Prompts Analysis Findings Root Cause Causal Questions Types Factors/ (Table A-1) Root Cause Details (Table A-1) 14 To what degree Discuss whether patient assessments was all the were completed, shared, and necessary accessed by members of the information treatment team, to include providers, available when according to the organizational needed? processes. Identify the information Accurate? systems used during patient Complete? care. Discuss to what extent the Unambiguous? 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 Analysis of factors related to is communication communication should include among participants evaluation of verbal, written, electronic adequate? 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 Consider processes that proactively appropriate manage the patient care environment. physical This response may correlate to the environment for response in Question #6 on a more the processes global scale. What evaluation tool being carried out? 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

150 Appendix

ROOT CAUSE ANALYSIS continued # Analysis Prompts Analysis Findings Root Cause Causal Questions Types Factors/ (Table A-1) Root Cause Details (Table A-1) 17 What systems are Identify environmental risk in place to identify assessments. Does the environmental current environment meet risks? 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 Describe variances in expected and failure-mode process due to an actual emergency responses have or failure mode response in been planned and connection to the event. Related to tested? 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 How does the overall culture organization’s encourage change, suggestions, and culture support risk warnings from staff regarding risky reduction? 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?

continued

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ROOT CAUSE ANALYSIS continued # Analysis Prompts Analysis Findings Root Cause Causal Questions Types Factors/ (Table A-1) Root Cause Details (Table A-1) 20 What are the Describe specific barriers to effective barriers to communication among caregivers communication that have been identified by the of potential risk organization. For example, residual factors? 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 Does leadership demonstrate leadership address accountability for implementing the continuum measures to reduce risk for patient of patient safety harm? Has leadership provided for events, including required resources or training? Does close calls, adverse leadership communicate corrective events, and actions stemming from any analysis unsafe, hazardous following reported risks? conditions?

22 How can Describe how orientation and orientation and ongoing education needs of the in-service training staff are evaluated and discuss its be improved? relevance to event (for example, competencies, critical thinking skills, use of simulation labs, evidence-based practice). 23 Was available Describe variances in the expected technology used process due to education, training, as intended? competency, impact of human factors, functionality of equipment, and so on: • Was the technology designed to minimize use errors or easy-to- catch mistakes? • Did the technology work well with the workflow and environment? • Was the technology used outside of its specifications?

24 How might Describe any future plans for technology be implementation or redesign. Describe introduced or the ideal technology system that can redesigned to help mitigate potential adverse events reduce risks in in the future. the future?

152 Appendix

CORRECTIVE ACTIONS Root Cause Causal Corrective Actions Action Strength Measure of Sample Size Types Factors/ (Table A-2) Success (Table A-4) (Table A-1) Root Cause (Numerator / Details Denominator) (Table A-1) (Table A-3) Action Item #1:

Action Item #2:

Action Item #3:

Action Item #4:

Action Item #5:

Action Item #6:

Action Item #7:

Action Item #8:

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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 • 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

Environmental factors • Noise, lighting, flooring condition, and so forth • Space availability, design, locations, storage • Maintenance, housekeeping Equipment/device/supply/ • Equipment, device, or product supplies problems or availability healthcare IT factors • 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/ • Disruptive or intimidating behaviors workforce factors • 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 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 Adapted from Department of Defense, Patient Safety Program. PSR Contributing Factors List – Cognitive Aid, Version 2.0. May 2013.

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TABLE A-2 . ACTION STRENGTH Action Strength Action Category Example Stronger Actions 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. (These tasks require less reliance on humans to remember to perform New devices with usability testing Perform heuristic tests of outpatient blood glucose the task correctly.) 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. Intermediate Redundancy Use two registered nurses to independently calculate Actions 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 patient- controlled analgesia (PCA) pumps; remove distractions for nurses when programming medication pumps. Education using simulation-based training, Conduct patient handoffs in a simulation lab/ with periodic refresher sessions and environment, with after-action critiques and debriefing. observations 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. 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 Warnings Add audible alarms or caution labels. to remember to perform the task correctly) 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 Falls that resulted in hip fractures in you measuring? diabetic patients over 70 years of age

Denominator All the opportunities in which the event Identify the patient population from The number of diabetic patients on could have occurred which to collect the information. 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

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158 Glossary

A are allowed to flow freely and participants are asked to adverse drug event An injury resulting from medical contribute fully and fairly, liberating them to develop a rich intervention related to a medication, array of creative solutions to the problems they’re facing.

adverse event A patient safety event that resulted in harm C to a patient. care The provision of accommodations, comfort, and affinity diagram An illustrative tool used to organize a treatment to an individual, implying responsibility for large volume of ideas or data into meaningful groups with safety, including care, treatment, service, habilitation, reha- logical connections. bilitation, 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 care recipient See patient. over a given time period (for example, monthly, quarterly) or for certain groupings (for example, health care organiza- change analysis A study of the differences between the tion level). expected and actual performance of a process. Change analysis involves determining the root causes of an event by B examining the effects of change and identifying causes. benchmarking Continuous measurement of a process, change management A concept that includes many tools product, or service compared to those of the toughest to focus on the human side of change. competitor, to those considered industry leaders, or to similar activities in the organization to find and implement check sheet A form used to sort and group data, using ways to improve it. This is one of the foundations of both check marks or similar symbols. total quality management and continuous quality improve- ment. Internal benchmarking occurs when similar processes close call A patient safety event that did not reach the within the same organization are compared. Competitive patient; also called a near miss or a good catch. benchmarking occurs when an organization’s processes are compared with best practices within the industry. common-cause variation See variation. Functional benchmarking refers to benchmarking a similar function or process, such as scheduling, in another industry. 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 comprehensive systematic analysis A process for identi- time, where participants have the opportunity to build on fying basic or causal factors underlying variation in perfor- the ideas of others. Brainstorming works best when ideas mance, including the occurrence or possible occurrence of a

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sentinel event. A root cause analysis is one type of system- error of omission A mistake that occurs as a result of an atic comprehensive analysis. action not taken. Examples include a delay in performing an indicated caesarean section, resulting in a fetal death; contributing factor A circumstance, action, or influence a nurse omitting a dose of a medication that should be that is thought to have played a part in the origin, develop- administered; and a patient suicide that is associated with a ment, or increased risk of an incident. lapse in carrying out frequent patient checks in a psychiatric unit. Errors of omission may or may not lead to adverse control chart A visual representation of tracking progress outcomes. over time. F corrective action See improvement action. failure Lack of success, nonperformance, nonoccurrence, corrective action plan The product of the root cause breaking down, or ceasing to function. In most instances, analysis that identifies the strategies that an organization and certainly within the context of this book, failure is what intends to implement to reduce the risk of similar events is to be avoided. It takes place when a system or part of a occurring in the future. The plan should address responsi- system performs in a way that is not intended or desirable. bility for implementation, oversight, pilot testing as appro- priate, time lines, and strategies for measuring the effective- failure mode and effects analysis (FMEA) A systematic ness of the actions. way of examining a design prospectively for possible ways in which failure can occur. It assumes that no matter how coupled system A system that links two or more activities knowledgeable or careful people are, errors will occur in so that one process is dependent on another for completion. some situations and may even be likely to occur. Synonym: A system can be loosely or tightly coupled. failure mode, effects, and criticality analysis (FMECA).

D fishbone diagram The visual representation to clearly display the various factors affecting a process. Synonym: direct cause See proximate cause. cause-and-effect diagram. discovery In the legal sense, the required disclosure of fivewhys A problem-solving technique that helps users to pertinent facts or documents by parties in a legal action or get to the root cause of the problem quickly without statis- proceeding. tical analysis by asking the question “Why?” five times.

DMAIC The acronym for Define, Measure, Analyze, flowchart A pictorial summary that shows with symbols Improve and Control. It is the core of Six Sigma method- and words the steps, sequence, and relationship of the ology that describes its problem-solving sequence. various operations involved in the performance of a func- tion or a process. 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 Gantt chart A graphical depiction of the time frame for a an action taken. Examples include a drug being adminis- long-term, complex project, including the numerous phases tered at the wrong time, in the wrong dose, or using the of the project, person(s) responsible, and targeted comple- wrong route; surgeries performed on the wrong side of the tion dates, used to help the project team gauge its progress. body; and transfusion errors involving blood crossmatched for another patient.

160 Glossary

H M

hazardous condition A circumstance (other than a malpractice Improper or unethical conduct or unrea- patient’s own disease process or condition) that increases sonable lack of skill by a holder of a professional or official the probability of an adverse event. position; often applied to physicians, dentists, lawyers, and public officers to denote negligent or unskillful perfor- histogram A visual representation displaying the mance of duties when professional skills are obligatory. ­distribution of the data within a range of values. measurement The process of collecting and I aggregating data.

improvement action A solution required to prevent a medication error A preventable event that may cause or problem from occurring or recurring due to the same root lead to inappropriate medication use or patient harm while cause or interaction(s) of root causes. Synonym: corrective the medication is in the control of the health care profes- action. sional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, incident report A written report, usually completed by a and systems, including prescribing; order communica- nurse and forwarded to risk management personnel, that tion; product labeling, packaging, and nomenclature; describes and provides documentation for any unusual compounding; dispensing; distribution; administration; problem, incident, or other situation that is likely to lead to education; monitoring; and use. 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 indicator 1. A measure used to determine, over time, those that the team members collectively find most worthy performance of functions, processes, and outcomes. 2. A of immediate attention. statistical value that provides an indication of the condition or direction over time of performance of a defined process N or achievement of a defined outcome. no-harm event A patient safety event that did not result individual served See patient. in harm to the patient.

L operational definition A description of a concept demonstrated by the process that includes a means of latent condition A condition that exists as a consequence measurement. An operational definition may be used of management and organizational processes and poses during the creation of a project charter, when defining a the greatest danger to complex systems. Latent conditions customer’s requirements, when collecting data, or when can be identified and corrected before they contribute to analyzing capability. mishaps. O Lean Six Sigma A patient-focused health care manage- ment philosophy that promotes various proven methods ordering See prescribing. of stabilizing, standardizing, and simplifying work processes to reduce waste and improve quality of care. Lean Six Sigma outcome measure A tool used to assess data that indicates practices contribute to reducing adverse events, increasing the results of performance or nonperformance of a function patient perception of high-quality care, raising levels of or procedure. staff retention and satisfaction, and saving the organization money.

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P process A goal-directed, interrelated series of actions, Pareto chart A vertical bar graph that displays the data events, mechanisms, or steps that transform inputs being studied in order from largest to smallest. into outputs. patient The terms individual served, patient, and care recip- process measure An intermediate indicator of the success ient all describe the individual, client, consumer, or resident of an intervention. who actually receives health care, treatment, and/or services. proximate cause A system failure that naturally and patient safety event An event, incident, or condition that directly produces a consequence. It is the superficial or could have resulted or did result in harm to a patient. See obvious cause for an occurrence. Treating only the symp- also adverse event, near miss, sentinel event. toms, or the proximate special cause, may lead to some short-term improvements but does not prevent the varia- policy A principle or method that is developed for tion from recurring. the purpose of guiding decisions and activities related to governance, management, care, treatment, and services. Q A policy is developed by organization leadership, approved by the governing body of the organization, and maintained quality improvement An approach to the continuous in writing. study and improvement of the processes of providing health care services to meet the needs of individuals and others. practice guidelines Tools that describe a specific proce- Synonyms: continuous quality improvement, continuous dure or processes found, through clinical trials or by improvement, organizationwide performance improvement, consensus opinion of experts, to be the most effective in and total quality management. evaluating and/or treating a patient, resident, or individual served who has a specific symptom, condition, or diagnosis. quality of care The degree to which care, treatment, and Synonyms: clinical practice guideline, practice parameter, services for individuals and populations increases the protocol, preferred practice pattern, and guideline. likelihood of desired health outcomes. Considerations include the appropriateness, efficacy, efficiency, timeliness, practitioner Any individual who is licensed and qualified accessibility, and continuity of care; the safety of the care to practice a health care profession (for example, physician, environment; and the individual’s personal values, practices, nurse, social worker, clinical psychologist, or respiratory and beliefs. therapist) and is engaged in the provision of care, treat- ment, or services. R prescribing The process of a licensed independent referral The act of sending an individual (1) from one practitioner or prescriber transmitting a legal order or clinician to another clinician or specialist, (2) from one prescription to the organization directing the preparing, setting or service to another, or (3) by one physician dispensing, and administering of a specific medication to a (the referring physician) to another physician(s) or other specific individual. It does not include requisitions for resource, either for consultation or care. medication supplies. relations diagram A tool used to generate understanding procedure 1. A series of steps taken to accomplish a of how various aspects of a problem are connected, desired end, as in a therapeutic, cosmetic, or surgical proce- including cause-and-effect relationships. dure. 2. A unit of health care, as in services and procedures. A procedure is not necessarily developed by organization relevance The applicability and/or pertinence of the leadership, approved by the governing body of the organiza- indicator to its users and customers. For Joint Commission tion, and maintained in writing. purposes, face validity is subsumed in this category.

162 Glossary

reliability The capability of an indicator to accurately and sentinel event 1. For purposes of Joint Commission consistently identify the events it is designed to identify accreditation: A patient safety event (not primarily related across multiple health care settings. to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, resilience The degree to which a system continuously permanent harm, or severe temporary harm. Sentinel events prevents, detects, mitigates, or ameliorates hazards or are a subcategory of adverse events. 2. For purposes of Joint incidents. Commission International accreditation: An unanticipated occurrence involving death or serious physical or psycho- risk points Specific points in a process that are susceptible logical injury—serious physical injury specifically includes to failure or system breakdown. They generally result from loss of limb or function. a flaw in the initial process design, a high degree of depen- dence on communication, nonstandardized processes, and/ services Structural divisions of an organization, its or failure or absence of backup. medical staff, or its licensed independent practitioner staff. root cause A fundamental reason for the failure or ineffi- SIPOC process map A high-level process map that ciency of a process. depicts suppliers, inputs, process, outputs, and customers. root cause analysis A process for identifying the basic Six Sigma A statistical model that measures a process or causal factor(s) underlying variation in performance, in terms of defects. Six Sigma allows an organization including the occurrence or possible occurrence of a to achieve quality by using a set of strategies, tools, and sentinel event. methods designed to improve processes so that less than 3.4 defects (that is, errors or unexpected or undesired results) run chart A tool for measuring variation in the perfor- exist for every million opportunities. mance of a given task or process. special-cause variation See variation. S staff As appropriate to their roles and responsibilities, all scatter diagram A illustration graphically plotting pairs people who provide care, treatment, and services in the of numerical data to display the possible relationship—not organization, including those receiving pay (for example, necessarily a cause-and-effect relationship—between one permanent, temporary, and part-time personnel, as well variable and another. as contract employees), volunteers, and health profession students. The definition of staff does not include licensed scientific method The systematic process of determining independent practitioners who are not paid staff or who are what is known about a problem, deciding what needs to be not contract employees. 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 indi- standard A principle of patient safety and quality of care vidual is physically prevented from leaving. Seclusion does that a well-run organization meets. A standard defines the not include involuntary confinement for legally mandated performance expectations, structures, or processes that must but nonclinical purposes, such as the confinement of a be substantially in place in an organization to enhance the person who is facing serious criminal charges or who is quality of care, treatment, or services. serving a criminal sentence.

163 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

standard deviation The square root of the variance. utility systems Building systems that provide support Standard deviation shows how much variation or dispersion to the environment of care, including electrical distribution from the average exists. and emergency power; vertical and horizontal transport; heating, ventilating, and air-conditioning (HVAC); standard work Sequence of repeatable tasks that an oper- plumbing, boiler, and steam; piped gases; vacuum ator performs. Creating standard protocols, procedures, and systems; and communication systems, including data workflow establishes the right way to fulfill customer (or exchange systems. patient) demand with the least amount of waste or vari- ability. Examples of standard work include standard oper- V ating procedures, policies, templates, models, and guides. value stream mapping A tool used to help health care suicide The act of ending one’s own life voluntarily organizations operate successfully by eliminating, or at least and intentionally. minimizing, non-value-added activities—that is, any steps in a process that do not contribute to a patient’s experience survey A key component in the accreditation process, of value. whereby a surveyor(s) conducts an on-site evaluation of an organization’s compliance with Joint Commission or Joint variation The differences in results obtained in measuring Commission International accreditation requirements. the same phenomenon more than once. Excessive variation frequently leads to waste and loss, such as the occurrence surveyor For purposes of Joint Commission accreditation, of undesirable patient health outcomes and increased cost a licensed physician, surgeon, podiatrist, dentist, nurse, of health services. The sources of variation in a process physician assistant, administrator, social worker, psychol- over time can be grouped into two major classes: common ogist, behavioral health care professional, or any other causes and special causes. Common-cause variation (also health care professional who meets The Joint Commission’s called endogenous-cause variation or systemic-cause variation) surveyor selection criteria, evaluates compliance with in a process is due to the process itself and is produced accreditation requirements, and provides education and by interactions of variables of that process inherent in consultation regarding compliance with accreditation all processes, not a disturbance in the process. It can be requirements to surveyed organizations or systems. removed only by making basic changes in the process. Special-cause variation (also called exogenous-cause variation U or extrasystemic cause variation) in performance results from assignable causes. Special-cause variation is intermittent, underlying cause The systems or process cause that allows unpredictable, and unstable. It is not inherently present in for the proximate cause of an event to occur. Underlying a system; rather, it arises from causes that are not part of the causes may involve special-cause variation, common-cause system as designed. variation, or both and may or may not be root causes.

164 Index

A on proximate causes, 65 Accountability, 9 Breakaway compliant fixtures, 59, 62, 72, 93, 97, 105 Accreditation C reporting status during sentinel event review process, 27–28 Care, ix, 159 safety culture in, 35 in early response to sentinel event, 36–37 sentinel event requirements in, 1, 4, 7, 18, 21, quality of, 162 28–29, 31 recipients of, ix, 162. See also Patients survey process in, 42, 46 Cause-and-effect relationships Action plan, 85–108. See also Corrective action plan fishbone diagrams on, 112. See also Fishbone diagrams Active failures, 7, 8 relations diagrams on, 133–134, 163 Ad hoc team members, 50 Change analysis, 65, 67, 75, 112, 116, 159 Adverse drug events, 159 Change management, 112, 117 Adverse events, v, 17–18, 159 in corrective actions, 85, 103–104 frequency/severity matrix on, 4, 5–6 definition of, 159 range of, 17–18 in Robust Process Improvement, 4, 111 response to, 19 Change process, 100–101 risk of recurrence, 10, 11 resistance to, 100 state reporting requirements on, 25 stages of, 101, 103–104 variation as factor in, 8 Check sheets, 112, 118, 159 Affinity diagrams, 65, 68, 85, 112, 113–114, 159 Clinical practice guidelines, 162 Aggregate data, 29, 71–72, 106, 159 Close calls, 159 and continuous variable indicators, 71–72 contributing and protective factors in, vi and rate-based indicators, 71 frequency/severity matrix on, 4, 5–6 American Society for Healthcare Risk Management, 37 as learning opportunity, 3–4, 19 Assessment process factors, 68 policy evaluation checklist on, 34 Audio recordings, 58, 59 problem statement on, 53 root cause analysis of, vi, 2, 4, 7, 19, 84 B as signal of risk, vi, 18 Baseline data, 70, 102, 104 Comment questions, 60 Benchmarking, 106, 159 Commitment to excellence, 4 Blame Common-cause variations, 8, 9, 76, 164 and creating no-blame environment, 52, 53, 60, 83 Communication fear of, 58 as causal factor, 68, 81, 155 Brainstorming, 67, 112, 115, 159 contact list for, 37, 39–41 on contributing factors, 68 on corrective actions, 106–108 on corrective actions, 85, 95, 102, 115 disclosure checklist on, 43–45

165 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

effective strategies in, 45 categories of, 92 in interviews, 61 challenges in, 10, 106, 107 on investigation progress, 37–42, 56 change process in, 100–101, 103–104, 117 with patients and families, 42, 43–45, 68 communication of results in, 106–108 storytelling strategy in, 108 definition of, 92, 161 in team approach, 52–53, 56 DMAIC model in, 102, 103, 104, 111–113 Communication and Optimal Resolution (CANDOR), 42 expectations in, 97 Complexity, 159 failure mode and effects analysis of, 95, 101, 121 risk for system failures in, 54 follow-up on, 10, 29, 33, 106 Comprehensive Accreditation Manual, 19, 36 hierarchy of, 93, 94 Comprehensive systematic analysis, v, 23, 159–160 identification of, 93 confidentiality of, 28 immediate changes in, 72–73 requirement for, 1, 7, 18, 19, 24, 27, 28 implementation of, 96, 101–108 root cause analysis in, 28 individuals responsible for, 97, 100 Confidentiality issues internal comparisons of, 106 in communication with media, 37 location of, 100 developing policies on, 33, 34 measurements on, 70, 95, 97, 102, 103, 104, 105 in interviews, 61 mistake proofing in, 92–95 Joint Commission and JCI responsibility in, 28, 29, organizational processes in, 96 30, 33 performance targets in, 106 legal concerns in, 24–26, 33, 59 pilot test of, 101 in nonpunitive process, 83, 86 problems and remedies in, 106, 107 in team approach, 53 proposed, evaluation of, 95–97, 101 Contemplation stage in change process, 101 resources required for, 96 Continuous quality improvement, 30, 162 risk reduction strategies in, viii, 4, 7, 10, 27, 28, 86–92 Continuous variable indicators, 71 scientific method in, 95, 102 Contributing factors, 9, 11, 160 strength of, 93, 94, 156 differentiated from root causes, 79, 82 time frame for, 30, 96, 97, 98–99, 100 evaluation checklist on, 82 what, how, when, who, and where issues in, 97–100 identification of, 29, 66–69 Correlation, scatter diagrams on, 136 Control charts, 102, 106, 112, 119–120, 160 Costs in sentinel event reporting, 27 Core team members, 50, 51 Coupled systems, 54, 160 Corrective action plan, viii, 4, 7, 10–16, 23, 27, Culture, organizational, 31, 33–35, 36, 69, 77, 155 85–108, 160 hierarchies in, 54 acceptability of, viii, 10–11, 28, 33, 101, 102 safety in, 3, 31, 35–36 confidentiality of, 28 evaluation of, 95–97 D framework for, vii, 13, 28, 66, 76, 86, 145–157 Data collection. See Information and data collection goals, scope, and activities defined in, 97 Death in sentinel events, 1, 8, 18, 20 implementation of, 13, 16, 101–108 in common and special cause variations, 9 requirement for, 28, 30 in error of omission, 19 submission of, 28 frequency/severity matrix on, 5 time allowed for, 30 JCI policy on, 1, 7, 29, 32 what, how, when, who, and where issues in, 13, 97–100 review of, 19 Corrective actions, viii, 85–108 Decision making in team, 51 aggregate external databases on, 106 Defensiveness in interviews, 60, 61 barriers to, 96, 106, 107 Define, measure, analyze, improve, and control (DMAIC), benchmarks on, 106 102, 103, 104, 111–113, 160

166 Index

Direct causes, 9, 66. See also Proximate causes Ethical issues in disclosure of errors, 42 Disclosable information, 27–28, 33, 37, 42 Event investigation. See Problem investigation checklist on, 43–45 Evidence in sentinel events Discovery, 33, 59, 160 documentary, 37, 59, 62, 63 Disease transmission as sentinel event, 7, 29 physical, 59, 62 DMAIC process, 102, 103, 104, 111–113, 160 preservation of, 37, 62 Documentation Excellence, commitment to, 4 contact information in, 37, 39–41 Exogenous-cause (special-cause) variations, 8–9, 76, 164 as evidence, 37, 59, 62, 63 Expectations in corrective actions, 97 incident reports in, 37, 38, 161 Exploratory questions, 60 methods of, 58–59 Extrasystemic cause (special-cause) variations, 8–9, 76, 164 Drawings for recording information, 58, 59 F E Facilitator role in team approach, 50, 52, 56 Elopement, 20, 48, 160 Fail-safe design, 88 corrective actions in, 93 Failure mode, effects, and criticality analysis (FMECA), information collected on, 59 92, 160 literature review on, 62 Failure mode and effects analysis (FMEA), 112, 121–122 reporting mechanism for, 56 of corrective actions, 85, 95, 101 team investigation of, 51, 56, 93 definition of, 160 Emergency department wait times, run chart on, 135 as proactive process, vii, 4, 92, 121–122 Endogenous-cause (common cause) variations, 8, 9, root cause analysis compared to, 92 76, 164 root causes identified in, 4, 92 Environmental factors, viii, 67, 69, 77, 155 Failures, v, 68 checklist on, 81 active, 7, 8 in elopement, 59, 62 in complex systems, 54 identification of, 68 contributing factors in, 9 in medication errors, 15 definition of, 160 questions in analysis of, 78 root causes in, 4 in suicide event, 59, 79, 93 Falls Equipment factors, viii, 18, 67, 68, 69, 155 from bed, 9, 58, 66 categories of, 77 multiple root causes in, 9, 66, 83 identification of, 68 Sentinel Event Database on, 83 in medication errors, 15, 59 Family, communication with, 42, 43–45, 68 preservation of evidence on, 37, 62 Fear of blame, 58 Errors, 19, 86, 87 Federal reporting requirements, 25 of commission, 19, 160 Fire, 20 in communication, 68 Fishbone diagrams, 67, 75, 112, 123–124 communication with patient and family on, 42 on corrective actions, 95, 102 compared to sentinel events, 32 definition of, 160 in high-reliability organizations, v, 2 on multiple problems, 79 learning from, 3 on proximate causes, 65 medication-related. See Medication errors on suicide event, 93, 124 of omission, 19, 160 Five whys, 67, 160 proximate and underlying causes of, 7 Flow, in process, 113 root cause analysis of, vii, 1, 2 Flowcharts, 66, 75, 112, 125–126, 160 Swiss chess model of, 2, 3, 86 on corrective actions, 85, 95, 102 variation as factor in, 1 on medication errors, 126

167 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

on process problems, 67 Improvement actions, 85–108. See also Corrective actions on proximate causes, 65, 125 Incident reports, 37, 38, 161 Follow-up activities, 29, 33 Indicators in corrective actions, 10, 29, 33, 106 definition of, 70, 161 in root cause analysis, 10, 12–13 selection of, 70, 71, 72, 105 Follow-up questions, 60, 61 Individual served, ix, 162. See also Patients Forcing functions, 86 Infant abductions, 7, 29 Foreign object, unintended retention of, 20, 83 problem statement on, 53 Framework for Root Cause Analysis and Corrective Action risk points and risk reduction strategies in, 54, 88, 91 Plan, vii, 13, 28, 66, 76, 86, 145–157 Information and data collection, 13, 58–63 Frequency/severity matrix on safety-related problems, baseline data in, 70, 102, 104 4, 5–6 checklist on, 72, 74 Functions on close calls, 18 definition of, 93, 160 confidentiality in, 33, 53, 59 forcing functions in risk reduction, 86 on corrective actions, 105–106 criteria-based review of, 79 G in DMAIC model, 102, 103, 104, 111 Gantt charts, 75, 112, 127 in high reliability organizations, 3–4 on corrective actions, 85, 97, 98–99, 127 interviews in, 59–61 definition of, 160–161 legal issues in, 59 on proximate causes, 65, 127 literature review in, 62–63 Good catches, 19, 159. See also Close calls measurements in, 69–72. See also Measurement Group interviews, 60, 61 preservation of evidence in, 37 on proximate and underlying causes, 66–72 H recording methods in, 58–59 Hand hygiene, 76 team approach to, 48, 53, 58–63 Hazardous conditions, 18, 19, 161 Information-related factors, 67, 77 High-reliability organizations and industries, v, 2–4, 86, 88 checklist on, 80 safety culture in, 35 identification of, 68 Histograms, 102, 112, 128 in medication errors, 15 on corrective actions, 85, 106, 128 questions in analysis of, 78 definition of, 161 in suicide event, 77, 79 on root causes, 75 team investigation of, 50, 77 Human factors, viii, 11, 18, 67 Information technology, 56, 69, 155 categories of, 77 Institute for Safe Medication Practices, 92 in failure of corrective actions, 106, 107 Institute of Medicine, v identification of, 68 Insulin management, SIPOC process map on, 138 in medication errors, 15 International Patient Safety Goals, 31 Human resources issues, 59, 77 Interviews, 58, 59–61 checklist on, 80 evidence on, 62 J questions in analysis of, 78 The Joint Commission risk reduction strategies in, 90 acceptance of corrective action plan by, 10–11, 101 in suicide event, 77, 79 on comprehensive systematic analysis, 1, 7, 19 on failure mode and effects analysis, 92 I Framework for Root Cause Analysis and Corrective Immediate causes. See Proximate causes Action Plan of, 13, 28, 66, 76, 86, 145–157 Immediate changes, design and implementation of, 72–73

168 Index

Public Information Policy of, 24, 28 M reporting of sentinel events to, 17, 19, 21–28 Malpractice claims, 42, 161 Robust Process Improvement strategies of, vii, 4, 111 Management factors, 69, 155 Sentinel Event Database of, viii, 22, 29, 54, 79, 83 in corrective actions, 100 sentinel event definition of, 1, 21, 23, 27, 28, 31, 32 Measurement, 69–72 Sentinel Event Policy of, vii, viii, 10, 11, 17, 18, 19–29, checklist on, 72, 105 32–33 choice of measures in, 70, 71, 72, 105 Universal Protocol for Preventing Wrong Site, Wrong of corrective actions, 70, 95, 97, 102, 103, 104, 105 Procedure, Wrong Person Surgery of, 87–88 data in, 70, 159 website resources of, 11, 21, 22, 26, 28, 55 definition of, 69, 161 The Joint Commission Connect extranet site, vii, 21, 22, in DMAIC model, 102, 103, 104, 111 26, 28 indicators used in, 70, 71, 72, 105, 161 Joint Commission International (JCI) key questions on, 73, 105 acceptance of corrective action plan by, 10–11, 30, outcome measures in, 70–71, 162 33, 101 process measures in, 70–71, 162 reporting of sentinel events to, 21, 29–30 purposes of, 69–70 sentinel event definition of, 1, 4, 29, 30, 31, 32 Measure of success, 29, 157 Sentinel Event Policy of, 4, 10, 17, 29–30, 32–33 Media standards of, 4, 7, 30–31 notification of event, 37 The Joint Commission Perspectives, 21, 54 reports on patient safety events in, vi, 2, 21, 26, 30, 54 L Medical mistakes and errors, 32, 42 Medication errors, vii, 2, 48 Labeling of medications, 15 check sheet on, 118 Laboratory testing close calls in, 18 affinity diagram on, 114 common causes of, 7 value stream mapping on, 144 corrective actions in, 2, 93, 95, 97, 105 Latent conditions, 7, 8, 82, 161 definition of, 161 Leadership documentary evidence on, 63 checklist on, 81 evidence in, 37, 62 in corrective actions, 10, 100, 107 flowcharts on, 126 in high-reliability organizations, 2, 3–4 histogram on, 128 and organizational culture, 31, 33–35, 36, 69, 77, 155 information collected on, 59 quality improvement responsibilities of, 30–31 literature review on, 63 questions in analysis of, 78 media reports on, vi, 2, 54 reports provided to, 107 mistake proofing in prevention of, 93 sentinel event policy on responsibilities of, 31 operational definition of, 130 standards on, 19 in ordering, 54 survey process on, 42 organizational hierarchy as factor in, 54 of team, 49, 50, 52–53, 56 proximate causes of, 9 Lean Six Sigma, 103, 111, 113, 161 questions in investigation of, 11, 15, 66, 67 and Robust Process Improvement, 4, 111 reporting of, 56 Leape, Lucian L., 86, 87 risk containment in, 37 Legal issues, 23–26, 33, 34, 37, 42 risk points and risk reduction in, 88, 89–90 in confidentiality concerns, 24–26, 33, 59 root causes of, 9, 11, 15 in malpractice claims, 42, 161 scatter diagram on, 137 Literature review, 62–63 team investigation of, 51, 56, 95, 105 variation as factor in, 8

169 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

Meetings of team members, 49, 51–52 reporting of, 21 Mistake proofing, 92–95 response to, 19 Motorola, 111, 113 as sentinel events, 1, 17–18, 19, 20, 26. See also Multivoting, 75, 85, 102, 112, 129, 161 Sentinel events Performance improvement, 36 N in high reliability organizations, 3 National Academy for State Health Policy (NASHP), 25 high-risk processes identified in, 54 National Center for Patient Safety (Veterans Affairs), 92, 93 immediate changes for, 73 National Patient Safety Foundation, vii, 2 Joint Commission standards on, 7, 42 National Patient Safety Goals, 29, 33 leadership in, 3, 36 National Quality Forum, 25 root cause analysis in, 3, 4, 111 Near-miss events. See Close calls team approach to, 36, 49, 50 No-blame environment, 52, 53, 60, 83 tools and techniques for. See Tools and techniques No-harm events, vi, 18, 19, 161 Photographs for recording information, 58, 59 Non-value-added activities, 164 Physicians change affecting, 101 O communication errors of, 68 Office of Quality and Patient Safety, 21 communication with patient and family, 42 On-site visits, 27, 28, 42 in organizational hierarchy, 54 Open-ended interview questions, 60, 61 as team members, 50 Operational definitions, 85, 112, 130, 161 Pilot test of corrective actions, 101 Ordering Policy, definition of, 162 changing system of, 101 Practice guidelines or parameters, 93, 162 as risk-prone system, 54 Practitioner, definition of, 162 Organizational culture, 31, 33–35, 36, 69, 77, 155 Precontemplation stage in change process, 101 hierarchies in, 54 Preferred practice patterns, 162 safety in, 3, 31, 35–36 Preparation for root cause analysis, viii, 47–63 Organizationwide performance improvement, 162 Prescribing, definition of, 162 Outcome measures, 70–71, 162 Proactive risk reduction, 19, 86 P failure mode and effects analysis in, vii, 4, 92, 121–122 leadership in, 35, 36 Pareto charts, 75, 85, 102, 112, 131–132, 162 root cause analysis in, vi, 4, 19, 88, 92 Patients value of, vi affected by sentinel event, 36–37, 42, 43–45 Problem definition, 53–56, 66 communication errors with, 68 in complex systems, 54 identification of, 15 in DMAIC model, 102, 103, 104, 111 use of term, ix, 162 identification of high-risk processes in, 54 Patient Safety and Quality Improvement Act (2005), 25 in multiple causal factors, 53–54 Patient safety events, v operational definition in, 85, 112, 130, 161 as adverse events, 18, 19. See also Adverse events Problem investigation, 58–63 as close calls, 18, 19. See also Close calls in DMAIC model, 102, 103, 104, 111 definition of, 18, 32, 162 in early response, 37–42 examples of, vi, 20 evidence in, 37, 59, 62–63 frequency/severity matrix on, 4, 5–6 fear of blame in, 58 investigation of, 1–2 identifying root causes in, 75–84 multiple, 7 immediate changes made during, 72–73 as no-harm events, vi, 18, 19, 161 improving staff comfort in, 58

170 Index

literature review in, 62–63 R questions asked in, 66, 67 Rape, 7, 20, 29, 32 recording methods in, 58–59 Rate-based indicators, 71 scientific method in, 95 Redundancy, in risk reduction strategies, 88 team approach to, 48–53 Referrals, 162 witness statements and observations in, 59–61 Relations diagrams, 75, 85, 112, 133–134, 163 work plan in, 54–56 Relevance, definition of, 163 written statements in, 58, 61 Reliability, 163 Procedure Reporting of sentinel events, 33, 37–42, 56 definition of, 162 benefits of, 21–22 failures related to, 68 confidentiality in, 24–26, 28, 29, 30, 33, 37 Process costs in, 27 contributing factors in, 9, 66–67, 69 developing policies on, 31–33 corrective actions in, 93 disclosable information in, 27–28, 33, 37, 42, 43–45 coupled systems in, 54 documentation for, 37, 38–41 definition of, 93, 162 by electronic submission, 28 failure to follow, 68 incident reports in, 37, 38, 161 flawed, 68, 93 to The Joint Commission, 17, 19, 21–28 flow in, 113 to Joint Commission International, 21, 29–30 high-risk, 54 legal issues in, 23–26 measures of, 70–71, 162 methods of, 22–23, 26, 27, 28, 29–30 pull in, 113 in on-site interactions, 27, 28 risk points in, 88 policy evaluation checklist on, 34 risk reduction strategies in, 87 state and federal requirements on, 25 root cause analysis of, 11 in survey process, 42 stable and unstable, 8 time allowed for, 28 variations in, 8, 87 Research programs, 31 Project REFRESH, 29 Resilience, vi, 163 Protocols, 162 Reviewable sentinel events Proximate causes, viii, 9, 65–74 examples of, 21, 24 definition of, 162 JCI policy on, 7, 29–30, 33 identification of, 66–69 The Joint Commission policy on, 11, 18, 19, 28, 33 immediate changes made in, 72–73 medication errors as, 11, 15 measures on, 69–72 Risk containment, 37 root causes compared to, 7, 79 Risk management, 37 staff interviews on, 60 Risk points, 9, 11, 88, 89–91, 163 underlying causes of, 76–79 Risk reduction strategies, 86–92 Public Information Policy, 24, 28 in commitment to excellence, 4 Pull, in process, 113 corrective actions in, viii, 4, 7, 10, 27, 28, 86–92 Q fail-safe design in, 88 failure mode and effects analysis in, 4, 121–122 Quality improvement, 4, 30–31, 162 follow-up activities in, 10 Quality Improvement and Patient Safety (QPS) standards, forcing functions in, 86 4, 30–31 framework for, vii Quality of care, 162 in high-reliability organizations, 86, 88 in high-risk processes, 54

171 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

identification of, 88 preparation for, viii, 47–63 immediate changes in, 72–73 proactive, vi, 4, 19, 88, 92 levels of design in, 86–87 problem definition in, 53–56. See also in multiple root causes, 9 Problem definition proactive. See Proactive risk reduction problem investigation in, 58–63. See also redundancy in, 88 Problem investigation Sentinel Event Database on, 29 proximate causes in, 7, 65–74. See also Proximate causes systems approach in, 2, 86, 87–88 questions asked in, 11, 15, 66, 67, 78, 147–152 Risk signals, vi, 18 recording methods in, 58–59 Robust Process Improvement (RPI), vii, 4, 111 reluctance in, 83–84 Root cause retrospective, 4 contributing cause compared to, 79, 82 sharing information from, 9, 17, 29, 54 definition of, 1–2, 163 steps in, 13, 16, 47, 57, 65, 75, 85 evaluation checklist on, 82 submission of, 28 identification of, v, viii, 75–84 in survey process, 46 multiple, 9, 53–54, 79–84 systems approach to, 9, 11, 14 proximate cause compared to, 7, 79 team approach to, 7, 48–53. See also Team approach pruning list of, 79 time allowed for, 27, 28, 30, 56 ranking criteria on, 4, 5–6, 53–54 tools and techniques in, 112. See also Tools rules on statement of, 10, 14 and techniques Sentinel Event Database on, 29, 79, 83 work plan in, 48–49, 54–56 types of, 69 Run charts, 85, 112, 135, 163 Root cause analysis, v–vii acceptability of, 28, 30, 33 S benefits of, 9 Safety, 86–87 case studies on, 2 culture of, 3, 31, 35–36 causal statement in, 10, 14 designing for, 87 clarification of issues in, 76 Safety Assessment Code Matrix, 5–6 confidentiality in, 33, 59, 83. See also Sampling methodology, 157 Confidentiality issues Scatter diagrams, 85, 112, 136–137, 163 corrective action plan produced in, 4, 10–16, 85–108. Scientific method, 95, 102, 163 See also Corrective action plan Seclusion, 163 criteria-based review of, 79 errors in, 16 definition of, v, 1–2, 163 Sentinel Event Alerts, 29, 35, 54, 55 effective, strategies for, 11 Sentinel Event Database, viii, 22, 29, 54, 79, 83 evaluation checklist on, 12–13 Sentinel Event Measure of Success (SE MOS), 29, 33 and failure mode and effects analysis, 4, 92 Sentinel Event Policies fear of blame in, 58 comparison of, 32–33 follow-up activities in, 10, 12–13, 29 evaluation checklist on, 34 framework for, vii, 13, 28, 66, 76, 86, 145–157 goals of, 21, 32 in high reliability industries, 2–4 of The Joint Commission, vii, viii, 10, 11, 17, 19–29, immediate changes made during, 72–73 32–33 improvement challenges in, 10 of Joint Commission International, 4, 10, 17, 29–30, maximizing value of, 10 32–33 in multiple safety events, 7, 53–54 steps in development of, 31–33 overview of, vii–viii, 1–16 in team approach, 51 performance improvement in, 3, 4, 111 Sentinel events, v, viii, 17–46 annual number reported, 23, 24

172 Index

appropriate patient care in, 36–37 performance factors related to, 69, 155 communication and disclosure on, 33, 37–42, 54 in team approach, 49 compared to medical errors, 32 Stakeholder analysis, 85, 112, 139–140, 163 comprehensive systematic analysis of. See Comprehensive Standard deviation, 111, 119, 164 systematic analysis Standards, 164 confidentiality issues in. See Confidentiality issues on leadership, 19 criterion for, 8 on quality improvement and patient safety, 4, 30–31 definitions of, 1, 4, 17–18, 26, 27, 29, 31, 34, 163 on sentinel events, 4, 7, 32 documentation of. See Documentation Standard work, 85, 112, 141–142, 164 evidence in. See Evidence in sentinel events State reporting requirements, 25 examples of, 20, 48 Storage of medications, 15 follow-up activities on, 10, 12–13, 29, 33 Storytelling as communication strategy, 108 framework for response to, 13 Suicide, 20, 48, 164 investigation of, vi, 1, 37–46. See also corrective actions in, 93, 97, 105 Problem investigation documentary evidence on, 63 leadership and organizational culture in, 31, 33–35 fishbone diagram on, 93, 124 legal issues in, 23–26, 33, 37, 42 immediate changes after, 72–73 preliminary assessment of, 27 information collected on, 59 preparation for root cause analysis in, 47–63 literature review on, 62 process flow in, 21, 22 physical evidence on, 62 proximate cause of. See Proximate causes problem statement on, 53 reporting of. See Reporting of sentinel events proximate causes in, 68 response to, 7, 18, 19, 27, 28–29, 33, 35, 36–37 reporting mechanism in, 56 reviewable. See Reviewable sentinel events risk points and risk reduction strategies in, 54, 88, risk containment in, 37 90–91 risk points in, 9, 11, 88, 89–91, 163 root causes in, 77, 79, 83 and safety culture, 35–36 Sentinel Event Database on, 83 standards related to, 4, 7 team investigation of, 51, 56, 68, 77, 93, 105 types of, 24 Suppliers, inputs, process, outputs, customers (SIPOC) underlying cause of. See Underlying causes process map, 85, 112, 138, 163 variation as factor in, 1, 8–9. See also Variations Surgical procedures Services, ix, 163 brainstorming on, 115 Severe temporary harm, 1, 8, 18, 19 control charts on patterns in, 120 examples of, 20 retained surgical item in, 20, 83 Severity/frequency matrix on safety-related problems, risk points in, 88 4, 5–6 universal protocol on, 73, 74, 87–88 Sexual abuse and assault, 7, 20, 29, 32 wrong-site, wrong-procedure, or wrong-patient. Single-event indicators, 71 See Wrong-site, wrong-procedure, or SIPOC process map, 85, 112, 138, 163 wrong-patient surgery Six Sigma, 111, 163 Survey, 27, 42, 46, 164 Lean, 103, 111, 113, 161 Surveyors, 27, 42, 46, 164 Special-cause variations, 8–9, 76, 164 Swiss cheese model on errors, 2, 3, 86 Stable process, 8 Systemic-cause (common-cause) variation, 8, 9, 76, 164 Staff, vi, 163 Systems approach failure to follow process, 68 in high reliability industries, 2 interviews with, 59–61 in risk reduction strategies, 2, 86, 87–88 medication errors of, 15 in root cause analysis, 9, 11, 14 orientation and training on sentinel event policy, 33, 34

173 ROOT CAUSE ANALYSIS IN HEALTH CARE: TOOLS AND TECHNIQUES, Sixth Edition

T stakeholder analysis, 85, 112, 139–140, 163 Team approach, 7, 48–53, 69 standard work, 85, 112, 141–142, 164 ad hoc members in, 50 value stream mapping, 85, 112, 143–144, 164 advantages of, 49 Total quality management, 162 communication in, 52–53, 56 Toyota Production System, 111, 113 composition of team in, 49–50, 51 Training of staff on sentinel event policies, 33, 34 confidentiality in, 53 Treatment delay, 48 core members in, 50, 51 corrective actions in, 95, 105 in corrective actions, 85–108 information collected on, 59 essential elements in, 49 literature review on, 62–63 facilitator role in, 50, 52, 56 multiple root causes in, 83 failure mode and effects analysis in, 92 reporting mechanism in, 56 icebreaker activities in, 53 Sentinel Event Database on, 83 identification of underlying causes in, 76–79 team investigation of, 51, 56, 95, 105 leaders in, 49, 50, 52–53, 56 U meetings in, 49, 51–52 mission of, 51 Uncontrollable factors, viii, 9, 67, 77 no-blame environment in, 52, 53 questions in analysis of, 78 in performance improvement, 36, 49, 50 Underlying causes, 7, 8 in problem identification, 53–56 definition of, 164 in problem investigation, 58–63 identification of, 67, 76–79 rules in, 50–52, 53 measures on, 69–72 Telephone interviews, 61 Universal Protocol for Preventing Wrong Site, Wrong To Err is Human: Building a Safety Health System, v Procedure, Wrong Person Surgery, 73, 74, 87–88 Tools and techniques, viii, 65, 111–144 Unsafe or hazardous conditions, 18, 19, 161 affinity diagrams, 65, 68, 85, 112, 113–114, 159 Unstable process, 8 brainstorming. See Brainstorming Utility systems, 9, 50, 63, 164 change analysis, 65, 67, 75, 112, 116, 159 V change management. See Change management Value stream mapping, 85, 112, 143–144, 164 check sheets, 112, 118, 159 Variations, vi, 8, 159, 164 comparison of, 112 common-cause, 8, 9, 76, 164 control charts, 102, 106, 112, 119–120, 160 in process, 8 DMAIC model, 102, 103, 104, 111–113, 160 root cause analysis of, 1 fishbone diagrams. See Fishbone diagrams special-cause, 8–9, 76, 164 flowcharts. See Flowcharts Veterans Affairs National Center for Patient Safety, 92, 93 FMEA. See Failure mode and effects analysis Video recordings, 58, 59 Gantt charts. See Gantt charts histograms. See Histograms W Lean Six Sigma, 4, 103, 111, 113, 161 Witness statements and observations, 59–61 multivoting, 75, 85, 102, 112, 129, 161 Womack, James, 111 operational definitions, 85, 112, 130, 161 Work of organization, functions and processes in, 93 Pareto charts, 75, 85, 102, 112, 131–132, 162 Work plan for sentinel event investigation, 48–49, 54–56 relations diagrams, 75, 85, 112, 133–134, 163 Wrong-site, wrong-procedure, or wrong-patient surgery, Robust Process Improvement, vii, 4, 111 7, 20 run charts, 85, 112, 135, 163 in error of commission, 19 scatter diagrams, 85, 112, 136–137, 163 evidence on, 62 SIPOC process maps, 85, 112, 138, 163 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

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