JCI FMEA-2010

Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction

Third Edition

Senior Editor: Ilese J. Chatman Project Manager: Meghan Anderson Publications Manager: Diane Bell Production Associate Director: Johanna Harris Executive Director: Catherine Chopp Hinckley, Hinckley, Ph.D. Joint Commission/Joint Commission International/Joint Commission Resources Reviewers: Gerald Castro, Anita Giuntoli, Linda Slepicka, Cherie Ulaskas, Francine Westergaard, Paul Reis Joint Commission Resources Mission The mission of Joint Commission Resources (JCR) is to continuously improve the safety and quality of care in the United States and in the international community through the provision of education and consultation services and international accreditation. Joint Commission International A division of Joint Commission Resources, Inc. The mission of Joint Commission International (JCI) is to improve the safety and quality of care 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 Joint Commission International. 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 services, nor is failure to include an organization name, product, or service to be construed as disapproval. © 2010 by The Joint Commission Joint Commission Resources, Inc. Inc. (JCR), a not-for-profit aff iliate of The Joint Commission, has been been designated by The Joint Joint Commission to publish publications and multimedia products. JCR reproduces and distributes these materials under license from the Joint Commission. All rights reserved. No No part of this publication may be reproduced in any form or by any means without written permission from the publisher. publisher. Printed in the U.S.A. 5 4 3 2 1 Requests for permission to make copies of any part of this work should be mailed to Permissions Editor Department of Publications Joint Commission Resources One Renaissance Boulevard Oakbrook Terrace, Terrace, Illinois 60181 U.S.A. [email protected] ISBN: 978-1-59940-525-4 LCCN: 2010927398 For more information about Joint Commission Resources, please visit htt p://www p://www.jcrinc.com. .jcrinc.com. For more information about Joint Commission International, please visit http://www.jointcommissioninternational.org.

Contents About This Book What Is Failure Mode and Effects Analysis?............................................................................................................................1 Purpose of This Book ............................................................................................................................................................2 Joint Commission International Standards ............................................................................................................................2 The Joint Commission Standards ..........................................................................................................................................2 How to Use This Book ..........................................................................................................................................................2 Acknowledgments ..................................................................................................................................................................3

Chapter 1. Failure Mode and Effects Analysis Overview A Step-by-Step Approach to FMEA......................................................................................................................................19 The Difference Between Root Cause Analysis and FMEA ....................................................................................................20 Why Use FMEA?..................................................................................................................................................................20 Limitations of FMEA ..........................................................................................................................................................22 Laying the Groundwork for Success......................................................................................................................................23

Chapter 2. Selecting a High-Risk Process and Assembling a Team Characteristics of a High-Risk Process ..................................................................................................................................25 Other Risk Areas to Consider ..............................................................................................................................................28 Sources for Identifying a Process to Analyze..........................................................................................................................30 Making FMEA Manageable..................................................................................................................................................32 Assembling the FMEA Team ................................................................................................................................................33 Training the Team on How to Conduct FMEA....................................................................................................................36 Establishing the Team Mission, FMEA Scope, and Ground Rules........................................................................................36

Chapter 3. Diagramming the Process and Brainstorming Potential Failure Modes Diagramming the Process ....................................................................................................................................................41 Walk Through the Process ....................................................................................................................................................46 Identify Potential Failure Modes ..........................................................................................................................................47 Using Additional Resources ..................................................................................................................................................50 Grouping Ideas into Categories ............................................................................................................................................50 Identifying Potential Effects of Failure Modes ......................................................................................................................53 Using an FMEA Worksheet ..................................................................................................................................................57

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Chapter 4. Prioritizing Failure Modes Determining Criticality ........................................................................................................................................................61 Determining Severity ............................................................................................................................................................62 Prioritizing Failure Modes ....................................................................................................................................................70

Chapter 5. Identifying Root Causes of Failure Modes Using Root Cause Analysis ..................................................................................................................................................75 Identify All Root Causes ......................................................................................................................................................76 Conducting the Root Cause Analysis....................................................................................................................................76 Tools to Help with Root Cause Analysis ..............................................................................................................................82 Criteria for Use and Truncation of Root Cause Analysis ......................................................................................................99

Chapter 6. Redesigning the Process Preparing to Redesign ........................................................................................................................................................101 Redesign Strategies..............................................................................................................................................................102 Different Methods for Redesign..........................................................................................................................................102 Taking a Methodical Approach ..........................................................................................................................................109 Considering the Impact of Redesign Elements....................................................................................................................109 Using Redesign Evaluation and Redesign Tools ..................................................................................................................114

Chapter 7. Analyzing and Testing the Process Organizing for Implementation ..........................................................................................................................................117 Testing the New Process......................................................................................................................................................119 The Plan-Do-Study-Act (PDSA) Cycle ..............................................................................................................................123

Chapter 8. Implementing and Monitoring the New Process Implementing the New Process ..........................................................................................................................................128 Measuring and Monitoring ................................................................................................................................................128 Analyzing Data ..................................................................................................................................................................133 Results ................................................................................................................................................................................135 Sustaining the Redesigned Process ......................................................................................................................................138

Index ..............................................................................................................................................................141

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Illustrations List of Figures Figure 1-1. FMEA Flowchart................................................................................................................................................21 Figure 2-1. The Swiss Cheese Model of Error Occurrence ....................................................................................................27 Figure 2-2. FMEA Team Start-Up Worksheet ......................................................................................................................38 Figure 3-1. Flowchart Symbols ............................................................................................................................................42 Figure 3-2. Example Flowchart: Radiation Treatment Planning Process................................................................................46 Figure 3-3. Example Process Map: Medication Reconciliation Process..................................................................................47 Figure 5-1. Example Affinity Diagram..................................................................................................................................85 Figure 5-2. Example Cause and Effect Diagram: Contributory Factors to Suicide ................................................................86 Figure 5-3. Example Cause and Effect Diagram: Improving Diabetes Screening ..................................................................87 Figure 5-4. Change Analysis Worksheet................................................................................................................................88 Figure 5-5. Patterns in Control Charts..................................................................................................................................89 Figure 5-6. Example Fault-Tree Analysis Diagram ................................................................................................................93 Figure 5-7. Example Histogram............................................................................................................................................94 Figure 5-8. Example Multivoting Results..............................................................................................................................95 Figure 5-9. Example Pareto Chart ........................................................................................................................................96 Figure 5-10. Example Run Chart..........................................................................................................................................98 Figure 5-11. Example Scatter Diagram ................................................................................................................................99 Figure 8-1. Gantt Chart......................................................................................................................................................133

List of Tables Table A-1. Joint Commission International Standard Requirements ......................................................................................3 Table A-2. Joint Commission Standards and Requirements..................................................................................................10 Table 2-1. Sentinel Event Statistics ......................................................................................................................................31 Table 3-1. Consideirng Failure Modes and Generic Effects ..................................................................................................53 Table 3-2. Workarounds and Potential Failures ....................................................................................................................54 Table 3-3. Example FMEA Worksheet..................................................................................................................................56 Table 4-1. Example Severity Scoring Scale ............................................................................................................................62 Table 4-2. Example Probability of Occurrence Scale ............................................................................................................64 Table 4-3. Example of a FMEA from an Interventional Pulmonology Program....................................................................65 Table 4-4. Screening for Diabetes: Potential Causes of Failure, Hazard Analysis, and Decision Tree Analysis ......................66 Table 4-5. Example Detectability Scale ................................................................................................................................69 Table 4-6. Determining Risk and Criticality for Priority Ranking ........................................................................................70 Table 5-1. Tool Matrix..........................................................................................................................................................84

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About This Book A

re errors in care, treatment, and services still attributed to individual human failure? This question may assume that humans generally perform flawlessly; perfect performance is a reasonable expectation. Therefore, if health care professionals just pay attention and work hard, nothing will go wrong.

are increasingly interdependent and are often interlocked or tightly coupled. Inconsistency, variable input, tight time constraints, a hierarchical culture, and the dependence on human intervention increase the risk of failure in system processes throughout an organization.

Education and training efforts, more extensive in health care than in most other fields, focus on teaching health care professionals to do “the right thing.” The assumption is that proper education and training will help health care professionals to not make mistakes. Hence, processes in health care organizations have historically been designed based on the premise that nothing will go wrong. When things do go wrong, the individuals involved are retrained, punished, or sanctioned. This widely held view, however, is seriously flawed.

Failure mode and effects analysis (FMEA) is one technique for

Improvement in performance, continuous process assessment, and a strong culture of safety are key to reduced errors in health care. Leaders have a direct responsibility; they are, in effect, responsible for the care, treatment, and services that the organization provides to its population. Leaders administer the operations of a health care organization and direct it on a day-to-day basis. They keep operations running efficiently so that the important work of the organization can continue. Therefore, undertaking a proactive risk assessment must be supported and led by leadership as defined in Joint Commission International’s “Quality Improvement and Patient Safety” chapter ( see Sidebar A-1, pages 3–9) and The Joint Commission’s “Leadership” and “Improving Performance” chapters ( see Table A-2, pages 10–18).

What Is Failure Mode and Effects Analysis? Health care is an exceedingly complicated system where accidents, errors, close calls (also known as near misses), sentinel events*, failures, and adverse events happen. In addition, health care processes exist throughout health care organizations that

systems improvement that can enhance safety. FMEA is a team-based, systematic, proactive, and reasoned-based technique that is used to prevent process and product problems before they occur. It provides a look not only at what problems could occur but also at how severe the effects of the problems could be. FMEA assumes that no matter how knowledgeable or

careful people are, failures will occur in some situations and could even be likely to occur. The focus is on what could allow the failure to occur. Ideally, FMEA can be used to help prevent failures from occurring. However, if a particular failure cannot be prevented, FMEA then focuses on protections that can be put in place to prevent the failure from reaching the individual receiving care, treatment, or services, or, in the worst case, mitigate its effects if the failure can cause harm. Those who are accustomed to an evidence-based approach to safety may view FMEA with some skepticism, more as a spec-

Defining FMEA Key Words Failure: When a system or part of a system performs

in a way that is not intended or desirable. Mode: The way or manner in which something, such as a failure, can happen. Failure mode is the manner in which something can fail. Effects: The results or consequences of a failure mode. Analysis: The detailed examination of the elements or structure of a process.

* Sentinel event Joint Commission International definition: An unanticipated occurrence involving death or major permanent loss of function. The Joint Commission definition: An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.

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ulative method than a scientific one. Even incident reporting isn’t 100% scientific. FMEA is a ready-made prospective process that has a good track record and a number of benefits. It is proactive instead of retrospective. It addresses problems that people have actually seen happen or errors they have almost made before it reaches the person receiving care. It is excellent, then, for capturing incidents that can and do occur and that generally are not captured any other way. Also, the multidisciplinary process pulls several kinds of information together (root causes as well as potential effects) and allows staff to target responses in new ways. FMEA can improve the safety for individuals receiving care by helping to identify failures and close calls and by protecting individuals from harm or mitigating harm when, despite an organization’s best efforts, failures do occur. It can narrow or eliminate gaps in quality and performance and yield improved outcomes. It is easy to learn and enhances organizationwide collaboration and understanding. In short, its use is good business practice. As with any other tool, the more you use FMEA, the more familiar and comfortable it becomes.

Purpose of This Book Joint Commission International and The Joint Commission require accredited health care organizations to conduct proactive risk assessments. The purpose of this book is to provide health care leaders and staff from around the world with a stepby-step guide to conducting FMEA if it is chosen by your organization as its proactive risk assessment method. Each chapter addresses a different step of the FMEA process. This book also offers case studies provided by several organizations that have conducted FMEA projects resulting in significant improvements. As you read through each step in the FMEA process, you will see how each of these organizations addressed each step.

Joint Commission International Standards As the international arm of The Joint Commission, Joint Commission International has been working with health care organizations, ministries of health, and organizations in more than 80 countries since 1994. In September 2007, Joint Commission International received accreditation by the International Society for Quality in Health Care (ISQua). Accreditation by ISQua provides assurance that the standards, training, and processes used by Joint Commission International to survey the performance of health care organizations meet the highest international benchmarks for accreditation entities.

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Joint Commission International accreditation and certification standards, measurable elements, and evaluation methods are designed to do the following: ■ Stimulate and support sustained quality improvement ■ Provide a framework for risk reduction ■ Provide a focus on creating a culture of safety Developed by health care experts from around the world and tested in every world region, these standards were created by health care professionals specifically for the health care sector and applicable to individual health care organizations and national health care systems.

The Joint Commission Standards Since 1951, The Joint Commission has offered and maintained state-of-the-art accreditation programs for health care organizations in the United States. Accreditation today provides organizations with standards, performance improvement tools, and an external evaluation of performance. An independent, notfor-profit organization, The Joint Commission accredits and certifies more than 17,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards. The Joint Commission’s standards, rationales, elements of performance, and evaluation method are designed to do the following: ■ Address the organization’s level of performance in key functional areas, such as care, treatment, and services, medication safety, and infection prevention and control ■ Set expectations for an organization’s actual performance and for assessing its ability to provide safe, high quality care ■ Set forth performance expectations for activities that affect the safety and quality of care

How to Use This Book Throughout this book, FMEA refers to the basic steps in a generic FMEA. Other proactive risk-reduction processes that encompass these basic steps may also be used. This book provides a place to start and an approach for consideration of FMEA. The key task is for each reader to use the process described here to proactively design or redesign potentially problematic health care processes in order to reduce the risk of harm.

About This Book

Much variation exists in how health care organizations have conducted FMEA to date and how they define the key steps and terms of a FMEA approach. Health care leaders and staff around the world can use this book to familiarize themselves with the concept of FMEA and then creatively design a proactive risk assessment and reduction process that is most likely to meet the organization-specific needs. More than a few hours or a couple of days are needed to learn to use and conduct a FMEA, although the process is not difficult. Advice from organizations that have conducted a FMEA can speed the process along. The tools and examples provided in this book can be easily adapted for use in a FMEA process. In addition, “Tip” boxes are provided throughout the book that may be used as a quick point of reference when conducting a FMEA. Online Extras are also available on Joint Commission Resources’ Web site at http://www.jcrinc.com/ FMEA10/extras. When this symbol is found with an example, the example can also be found on the Web site.

mitigation weapons for most high-risk processes in health care. The benefits of FMEA in preventing sentinel events that cause harm to individuals far outweigh its costs.

Acknowledgments A special thank you is extended to the following organizations that contributed FMEA processes to this book: ■ Amerikan Hastanesi, Istanbul, Turkey ■ Gaylord Hospital, Wallingford, CT ■ Health Care for the Homeless, Inc., Baltimore, MD ■ Miami Valley Hospital, Dayton, OH ■ University of Texas M.D. Anderson Cancer Center, Houston, TX We also thank Joint Commission International, The Joint Commission, and Joint Commission Resources reviewers Gerard Castro, Anita Giuntoli, Linda Slepicka, Cherie Ulaskas, Francine Westergaard, and Paul Reis. In addition, thank you to writer Julie Chyna for updating this important book.

FMEA is a powerful tool—at this point, perhaps the most powerful tool in the arsenal of proactive failure prevention and

Table A-1.

Joint Commission International Standards and Requirements

Quality Improvement and Patient Safety Chapter Standards and Requirements Standard QPS.1 Those responsible for governing and managing the organization participate in planning and measuring a quality improvement and patient safety program. Measurable Elements 1. The organization’s leadership participates in developing the plan for the quality improvement and patient safety program. 2. The organization’s leadership participates in measuring the quality improvement and patient safety program. 3. The organization’s leadership establishes the oversight process or mechanism for the organization’s quality improvement and patient safety program. 4. The organization’s leadership reports on the quality and patient safety program to governance. Standard QPS.1.1 The organization’s leaders collaborate to carry out the quality improvement and patient safety program. Measureable Elements 1. The organization’s leaders collaborate to carry out the quality improvement and patient safety program. 2. The quality improvement and patient safety program is organizationwide. 3. The program addresses the systems of the organization and the role of system design and redesign in quality and safety improvement. 4. The program addresses coordination among all components of the organization’s quality measuremenr and control activities. 5. The program employs a systematic approach to quality improvement and patient safety.

(continued)

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Table A-1.

continued


Standard QPS.1.2 The leaders prioritize which processes should be measured and which improvement and patient safety activities should be carried out. Measurable Elements 1. The leaders set priorities for measurement activities. 2. The leaders set priorities for improvement and patient safety activities. 3. The priorities include the implementation of the International Patient Safety Goals. Standard QPS.1.3 The leaders provide technological and other support to the quality improvement and patient safety program. Measurable Elements 1. The leaders understand the technology and other support requirements for tracking and comparing measurement results. 2. The leaders provide technology and support, consistent with the organization’s resources, for tracking and comparing measurement results. Standard QPS.1.4 Quality improvement and patient safety information is communicated to staff. Measurable Elements 1. Information on the quality improvement and patient safety program is communicated to staff. 2. The communications are on a regular basis through effective channels. 3. The communications include progress on compliance with the International Patient Safety Goals. Standard QPS.1.5 Staff are trained to participate in the program. Measurable Elements 1. There is a training program for staff that is consistent with their role in the quality improvement and patient safety program. 2. A knowledgeable individual provides the training. 3. Staff members participate in the training as part of their regular work assignment. Standard QPS.2 The organization designs new and modified systems and processes according to quality improvement principles. Measurable Elements 1. Quality improvement principles and tools are applied to the design of new or modified processes. 2. The following design elements are considered when relevant to the process being designed or modified: a) Is consistent with the organization’s mission and plans b)Meets the needs of patients, families, staff, and others c) Uses current practice guidelines, clinical standards, scientific literature, and other relevant evidence-based information on clinical practice design d)Is consistent with sound business practices

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Table A-1.

continued


e) Considers relevant risk management information f ) Builds on available knowledge and skills in the organization g)Builds on the best/better/good practices of other organizations h)Uses information from related improvement activities i) Integrates and connects processes and systems 3. Measures are selected to measure how well the newly designed or redesigned process operates. 4. Measurement data are used to evaluate the ongoing operation of the process. Standard QPS.2.1 Clinical practice guidelines and clinical pathways are used to guide clinical care. Measurable Elements 1. On an annual basis, clinical leaders determine those priority areas on which to focus the use of guidelines, clinical pathways, and/or clinical protocols. 2. The organization follows the following process in implementing clinical practice guidelines, clinical pathways, and/or clinical protocols: a) Select from among those applicable to the services and patients of the organization (mandatory national guidelines are included in this process, if present); b)Evaluate for their relevance to identified patient populations; c) Adapt when needed to the technology, drugs, and other resources of the organization or to accepted national professional norms; d)Assess for their scientific evidence; e) Formally approved or adopted by the organization; f ) Implement and measure for consistent use and effectiveness; g)Supported by staff trained to apply the guidelines or pathways; and h)Periodically updated based on changes in the evidence and evaluation of processes and outcomes. 3. The organization implements at least two clinical guidelines, clinical pathways, or clinical protocols for each identified priority area per 12-month period. 4. Clinical leaders can demonstrate how the use of clinical practice guidelines, clinical pathways, and/or clinical protocols has reduced variation in processes and outcomes. Standards QPS.3 through QPS.3.3 The organization’s leaders identify key measures in the organization’s structures, processes, and outcomes to be used in the organizationwide quality improvement and patient safety plan. Measurable Elements 1. The organization’s leaders identify targeted areas for measurement and improvement. 2. The measurement is part of the quality improvement and patient safety program. 3. The results of measurement are communicated to the oversight mechanism and periodically to the organizational leaders and the governance structure of the organization. Standard QPS.3.1 The organization’s leaders identify key measures for each of the organization’s clinical structures, processes, and outcomes.

(continued)

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Table A-1.

continued


Measurable Elements 1. The clinical leaders identify key measures for each of the following clinical areas: 1. Patient assessments 2. Laboratory services 3. Radiology and diagnostic imaging services 4. Surgical procedures 5. Antibiotic and other medication use 6. Medication errors and near misses 7. Anesthesia and sedation use 8. Use of blood and blood products 9. Availability, content, and use of patient records 10. Infection prevention and control, surveillance, and reporting 11. Clinical research 2. At least 5 of the 11 required clinical measures are selected from the Joint Commission International Library of Measures. 3. The leaders look at the “science” or “evidence” supporting each of the selected measures. 4. Measurement includes structure, processes, and outcomes. 5. The scope, method, and frequency are identified for each measure. 6. Clinical measurement data are used to evaluate the effectiveness of improvements. Standard QPS.3.2 The organization’s leaders identify key measures for each of the organization’s managerial structures, processes, and outcomes. Measurable Elements 1. The managerial leaders identify key measures for each of the following managerial areas: a) The procurement of routinely required supplies and medication essential to meet patient needs b)Reporting of activities as required by law and regulation c)Risk management d)Utilization management e) Patient and family expectations and satisfaction f ) Staff expectations and satisfaction g)Patient demographics and clinical diagnoses h)Financial management i) Prevention and control of events that jeopardize the safety of patients, families, and staff 2. The leaders look at the “science” or “evidence” supporting each of the selected measures. 3. Measurement includes structure, processes, and outcomes. 4. The scope, method, and frequency are identified for each measure. 5. Managerial measurement data are used to evaluate the effectiveness of improvements.

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About This Book

Table A-1.

continued


Standard QPS.3.3 The organization’s leaders identify key measures for each of the International Patient Safety Goals. Measurable Elements 1. The clinical and managerial leaders identify key measures for each International Patient Safety Goal. 2. International Patient Safety Goal measurement includes the areas identified in IPSG.1 through IPSG.6. 3. Measurement data are used to evaluate the effectiveness of improvements. Standard QPS.4 Individuals with appropriate experience, knowledge, and skills systematically aggregate and analyze data in the organization. Measurable Elements 1. Data are aggregated, analyzed, and transformed into useful information. 2. Individuals with appropriate clinical or managerial experience, knowledge, and skills participate in the process. 3. Statistical tools and techniques are used in the analysis process when suitable. 4. Results of analysis are reported to those accountable for taking action. Standard QPS.4.1 The frequency of data analysis is appropriate to the process being studied and meets organization requirements. Measurable Elements 1. The frequency of data analysis is appropriate to the process under study. 2. The frequency of data analysis meets organization requirements. Standard QPS.4.2 The analysis process includes comparisons internally, with other organizations when available, and with scientific standards and desirable practices. Measurable Elements 1. Comparisons are made over time within the organization. 2. Comparisons are made with similar organizations when possible. 3. Comparisons are made with standards when appropriate. 4. Comparisons are made with known desirable practices. Standard QPS.5 The organization uses an internal process to validate data. Measurable Elements 1.The organization integrates data validation into its quality management and improvement processes. 2.The organization has an internal data validation process that includes the following: a) Re-collecting the data by a second person not involved in the original data collection b)Using a statistically valid sample of records, cases, and other data. A 100% sample would only be needed when the number of records, cases, or other data is very small. c) Comparing the original data with the re-collected data d)Calculating the accuracy by dividing the number of data elements found to be the same by the total number of data elements and multiplying that total by 100. A 90% accuracy level is a good benchmark. (continued)

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Table A-1.

continued


e) When data elements are found not to be the same, noting the reasons (for example, unclear data definitions), and taking corrective actions. f ) Collecting a new sample after all corrective actions have been implemented to ensure the actions resulted in the desired accuracy level 3.The data validation process includes at least the measures selected as required in QPS.3.1. Standard QPS.5.1 When the organization publishes data or posts data on a public Web site, the data are validated by an independent third party. Measurable Elements 1. The organization has a process for obtaining independent third-party validation of its quality measures. 2. The independent third-party data validation process occurs for any performance measures posted publicly. Standard QPS.6 The organization uses a defined process for identifying and managing sentinel events.

Measurable Elements 1.The hospital leaders have established a definition of a sentinel event that at least includes the following: a) Unanticipated death unrelated to the natural course of the patient’s illness or underlying condition (for example, suicide) b) Major permanent loss of function unrelated to the patient’s natural course illness or underlying condition c) Wrong-site, wrong-procedure, wrong-patient surgery 2.The organization conducts a root cause analysis on all sentinel events in a time period specified by the hospital’s leaders. 3.Events are analyzed when they occur. 4.Hospital leaders take action on the results of the root cause analysis. Standard QPS.7 Data are analyzed when undesirable trends and variation are evident from the data. Measurable Elements 1. Intense analysis of data takes place when adverse levels, patterns, or trends occur. 2. All confirmed transfusion reactions, if applicable to the organization, are analyzed. 3. All serious adverse drug events, if applicable and as defined by the organization, are analyzed. 4. All significant medication errors, if applicable and as defined by the organization, are analyzed. 5. All major discrepancies between preoperative and postoperative diagnoses are analyzed. 6. Adverse events or patterns of adverse events during moderate or deep sedation and anesthesia use are analyzed. 7. Other events defined by the organization are analyzed. Standard QPS.8 The organization uses a defined process for the identification and analysis of near-miss events. Measurable Elements 1. The organization establishes a definition of a near miss. 2. The organization defines the type of events to be reported.

(continued)

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About This Book

Table A-1.

continued


3. The organization establishes the process for the reporting of near misses. 4. The data are analyzed and actions taken to reduce near-miss events. Standard QPS.9 Improvement in quality and safety is achieved and sustained. Measurable Elements 1. The organization plans and implements improvements in quality and safety. 2. The organization uses a consistent process for identifying priority improvements that are selected by the leaders. 3. The organization documents the improvements achieved and sustained. Standard QPS.10 Improvement and safety activities are undertaken for the priority areas identified by the organization’s leaders. Measurable Elements 1. The priority areas identified by the organization’s leaders are included in improvement activities. 2. Human and other resources needed to carry out an improvement are assigned or allocated. 3. Changes are planned and tested. 4. Changes that resulted in improvements are implemented. 5. Data are available to demonstrate that improvements are effective and sustained. 6. Policy changes necessary to plan, carry out and sustain the improvement are made. 7. Successful improvements are documented. Standard QPS.11 An ongoing program of risk management is used to identify and reduce unanticipated adverse events and other safety risks to patients and staff. Measurable Elements 1. The organization’s leaders adopt a risk management framework to include the following: a) Risk identification b)Risk prioritization c)Risk reporting d)Risk management e) Investigation of adverse events f ) Management of related claims 2. The organization conducts and documents use of a proactive risk-reduction tool at least annually on one of the priority risk processes. 3. The organization’s leaders take action to redesign high-risk processes based on the analysis. Source: Joint Commission International: Joint Commission International Accreditation Standards, 4th Edition. Oak Brook, IL: Joint Commission Resources, 2010.

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Table A-2.

Joint Commission Standards and Requirements Related to Proactive Risk

Assessment

Leadership Chapter Standards and Requirements Standard LD.03.02.01 The organization uses data and information to guide decisions and to understand variation in the performance of processes supporting safety and quality. Elements of Performance 1. Leaders set expectations for using data and information to improve the safety and quality of care, treatment, or services. 2. Leaders are able to describe how data and information are used to create a culture of safety and quality. 3. The organization uses processes to support systematic data and information use. 4. Leaders provide the resources needed for data and information use, including staff, equipment, and information systems. 5. The organization uses data and information in decision making that supports the safety and quality of care, treatment, or services. 6. The organization uses data and information to identify and respond to internal and external changes in the environment. 7. Leaders evaluate how effectively data and information are used throughout the organization. Standard LD.03.03.01 Leaders use organizationwide planning to establish structures and processes that focus on safety and quality. Elements of Performance 1. Planning activities focus on improving safety and health care quality. 2. Leaders can describe how planning supports a culture of safety and quality. 3. Planning is systematic, and it involves designated individuals and information sources. 4. Leaders provide the resources needed to support the safety and quality of care, treatment, or services. 5. Safety and quality planning is organizationwide. 6. Planning activities adapt to changes in the environment. 7. Leaders evaluate the effectiveness of planning activities. 8. All individuals who work in the organization, including staff and licensed independent practitioners, are able to openly discuss issues of safety and quality. 9. Literature and advisories relevant to safety are available to all individuals who work in the organization. 10. Leaders define how members of the population(s) served can help identify and manage issues of safety and quality within the organization. Standard LD.03.04.01 The organization communicates information related to safety and quality to those who need it, including staff, licensed independent practitioners, patients, residents, the individuals served, families, and external interested parties. Elements of Performance 1. Communication processes foster the safety of the patient, resident, or individual served, and the quality of care. 2. Leaders are able to describe how communication supports a culture of safety and quality.

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Table A-2.

continued

Joint Commission Standards and Requirements Related to Proactive Risk Assessment

3. Communication is designed to meet the needs of internal and external users. 4. Leaders provide the resources required for communication, based on the needs of patients, residents, individuals served, the community, physicians, staff, and management. 5. Communication supports safety and quality throughout the organization. 6. When changes in the environment occur, the organization communicates those changes effectively. 7. Leaders evaluate the effectiveness of communication methods. Standard LD.03.05.01 Leaders implement changes in existing processes to improve the performance of the organization. Elements of Performance 1. Structures for managing change and performance improvements exist that foster the safety of the patient, resident, or individual served, and the quality of care, treatment, and services. 2. Leaders are able to describe how the organization’s approach to performance improvement and its capacity for change support a culture of safety and quality. 3. The organization has a systematic approach to change and performance improvement. 4. Leaders provide the resources required for performance improvement and change management, including sufficient staff, access to information, and training. 5. The management of change and performance improvement supports both safety and quality throughout the organization. 6. The organization’s internal structures can adapt to changes in the environment. 7. Leaders evaluate the effectiveness of processes for the management of change and performance improvement. Standard LD.03.06.01 Those who work in the organization are focused on improving safety and quality. Elements of Performance 1. Leaders design work processes to focus individuals on safety and quality issues. 2. Leaders are able to describe how those who work in the hospital support a culture of safety and quality. 3. Leaders provide for a sufficient number and mix of individuals to support safe, quality care, treatment, and services. Applicable to the home care program: Note: For hospices providing inpatient care in their own facilities: Staffing for all services should reflect the volume of

patients, patient acuity, and the intensity of services needed to achieve the outcomes described in patients’ plans of care and to avoid negative outcomes. Applicable to the hospital program: Note: The number and mix of individuals is appropriate to the scope and complexity of the services offered.

Applicable to the laboratory program: Note 1: The following indicators demonstrate adequacy of technical and support staff to meet the service needs of the patients, including evenings, weekends, and holidays: • Overtime is not significantly high. (continued)

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Table A-2.

continued


• • • •

There are no lapses in quality control and proficiency testing. Performance testing and documentation of equipment maintenance have no lapses. Turnaround time is not prolonged. The quality of specimens, cultures, differential testing methods, or results is not jeopardized. Note 2: The following indicators demonstrate adequacy of supervisory staff to meet the service needs of the patients, including evenings, weekends, and holidays: • The background and experience of supervisory staff are consistent with work assignments and responsibilities. • Quality control, proficiency testing, and maintenance are well performed and evaluated. • Policies and procedures are current and well executed. • Turnaround time is satisfactory. • Record systems are well organized and current. • Quality improvement mechanisms are implemented. • Test analyses and specimen examinations are monitored to ensure that acceptable levels of analytic performance are maintained. 4. Those who work in the organization are competent to complete their assigned responsibilities. 5. Those who work in the organization adapt to changes in the environment. 6. Leaders evaluate the effectiveness of those who work in the organization to promote safety and quality. Standard LD.04.04.01 The organization complies with law and regulation. Elements of Performance 1. The organization is licensed, is certified, or has a permit, in accordance with law and regulation, to provide the care, treatment, or services for which the organization is seeking accreditation from The Joint Commission. Applicable to the ambulatory care, critical access hospital, home care, hospital, laboratory, long term care, and office-based surgery programs: Note: Each service location that performs laboratory testing (waived or non-waived) must have a Clinical Laboratory

Improvement Amendments of 1988 (CLIA ’88) certificate as specified by the federal CLIA regulations (42 CFR 493.55 and 493.3) and applicable state laws. Applicable to the home care, laboratory, and long term care program: Note: Applicable law and regulation include, but are not limited to, individual and facility licensure, certification,

Food and Drug Administration regulations, Drug Enforcement Agency regulations, Centers for Medicare & Medicaid Services regulations, Occupational Safety and Health Administration regulations, Department of Transportation regulations, Health Insurance Portability and Accountability Act, and other local, state, and federal laws and regulations. Applicable to the home care program: Note: For home health agencies that elect to use The Joint Commission deemed status option: If state or local law requires licensure of home health agencies, a home health agency that is not normally subject to licensure must be approved by the licensing authority as meeting the standards established for licensure. 2. The organization provides care, treatment, and services in accordance with licensure requirements, laws, and rules and regulations. 3. Leaders act on or comply with reports or recommendations from external authorized agencies, such as accreditation, certification, or regulatory bodies.

12

About This Book

Table A-2.

continued


Applicable to the ambulatory care program: 15. For ambulatory surgical centers that elect to use The Joint Commission deemed status option: The organization complies with part 493 of the Code of Federal Regulations. Note: Part 493 of the Code of Federal Regulations requires organizations who perform laboratory testing to maintain

compliance with Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). Applicable to the critical access hospital program: 5. The critical access hospital has an agreement with respect to credentialing and quality assurance with at least the following: • One hospital that is a member of the network • One quality improvement organization (QIO) or equivalent entity • One other appropriate and qualified entity in the state rural health care plan 6. Except as permitted for critical access hospitals having distinct part units under 42 CFR 485.647, as of January 1, 2004, the critical access hospital maintains no more than 25 inpatient beds that can be used for either inpatient or swing bed services. 7. The critical access hospital provides acute inpatient care for a period that does not exceed, on an annual average basis, 96 hours per patient. 8. The critical access hospital carries out or arranges for, at a minimum, an annual evaluation of its total program which includes a review of the utilization of its services, a representative sample of active and closed records, and health care policies. 9. For rehabilitation and psychiatric distinct part units in critical access hospitals: The critical access hospital has utilization review standards appropriate to rehabilitation or psychiatric services, or verification that the quality improvement organization (QIO) is conducting review activities. 11. For rehabilitation and psychiatric distinct part units in critical access hospitals: The rehabilitation or psychiatric distinct part unit(s) beds are physically separate from the critical access hospital’s other beds. 12. For rehabilitation and psychiatric distinct part units in critical access hospitals: The critical access hospital provides no more than 10 beds in a distinct part unit. Note: Beds in the rehabilitation and psychiatric distinct part units are excluded from the 25 inpatient bed-count limits

specified in the CoP from 42 CFR 485.620(a). Note: The average annual 96-hour length-of-stay requirement specified under the CoP from 42 CFR 485.620(b) does not apply to the 10 beds in the distinct part units specified in 42 CFR 485.647(b)(1). Admissions and days of inpatient care in the distinct part units are not taken into account in determining the critical access hospital’s compliance with the limits on the number of beds and length of stay in the CoP from 42 CFR 485.620. Performance Improvement Chapter Standards and Requirements Standard PI.01.01.01 The organization collects data to monitor its performance. Elements of Performance 1. The leaders set priorities for data collection. 2. The leaders identify the frequency for data collection. The organization collects data on the following: 3. Performance improvement priorities identified by leaders.

(continued)

13


Table A-2.

continued


Applicable to the ambulatory care, critical access hospital, hospital, and office-based surgery programs: 4. Operative or other procedures that place patients at risk of disability or death. 5. All significant discrepancies between preoperative and postoperative diagnoses, including pathologic diagnoses. 6. Adverse events related to using moderate or deep sedation or anesthesia. Applicable to the ambulatory care, critical access hospital, hospital, laboratory, and office-based surgery programs: 7. The use of blood and blood components. Applicable to the ambulatory care, critical access hospital, hospital, and laboratory programs: 8. All reported and confirmed transfusion reactions. Applicable to the critical access hospital and long term care programs: 9. The use of restraints. Applicable to the critical access hospital program: 10. The use of seclusion. Applicable to the critical access hospital and hospital programs: 11. The results of resuscitation. Applicable to the hospital and long term care programs: 12. Behavior management and treatment. Applicable to the long term care program: 13. Quality control activities. Note: Examples of topics for quality control activities include the delivery and content of food trays and laundry services. Applicable to the ambulatory care, behavioral health care, critical access hospital, home care, hospital, long term care, and office-based surgery programs: 14. Significant medication errors. 15. Significant adverse drug reactions. Applicable to the ambulatory care, critical access hospital, home care, hospital, laboratory, long term care, and office-based surgery programs: 16. Patient, resident (and as needed, the family), or individual served perception of the safety and quality of care, treatment, and services. Laboratory only: Note: The laboratory can use the hospital’s patient satisfaction survey as long as it addresses labora-

tory services. Applicable to the behavioral health care program: 16. The organization collects data on the following: • Whether the individual served was asked about treatment goals and needs • Whether the individual served was asked if his or her treatment goals and needs were met • The view of the individual served regarding how the organization can improve the safety of the care, treatment, or services provided Applicable to the home care program: 17. Patient satisfaction with and complaints about products and services. 18. The timeliness of response to patient questions, problems, and concerns.

14

About This Book

Table A-2.

continued


19. The impact of the organization’s business practices on the adequacy of patient access to equipment, items, services, and information. 20. For DMEPOS suppliers serving Medicare beneficiaries: The frequency of billing and coding errors. 21. Adverse events involving patients due to inadequate or malfunctioning equipment, supplies, or services (for example, injuries, accidents, signs and symptoms of infections, and hospitalizations). Applicable to the laboratory program: 22. Processes or outcomes related to patient preparation, including the provision of patient instructions and preparatory steps for the procedures. 23. Processes or outcomes related to handling specimens, including specimen collection, labeling, preservation, transportation, and rejection. 24. Processes or outcomes related to communication processes, including efficient transfer of information, completeness of test requisition, timeliness of reporting results, and accuracy of reports. 25. The laboratory collects data to determine whether tests it offers meet the needs of the clinical staff and the population served. Note: Data needed to support the review process may include age, disability groups, diagnoses, problems, levels of care,

and treatment. 26. To support the review of clinician practices, the laboratory collects data on test utilization. Applicable to the behavioral health care program: 27. The organization collects data to measure the performance of high-risk, high-volume, problem-prone processes provided to high-risk or vulnerable populations, as defined by the organization. Note: Examples of such processes include the use of restraints, seclusion, suicide watch, and behavior management and

treatment. Applicable to the ambulatory care program: 28. For ambulatory surgical centers that elect to use The Joint Commission deemed status option: The organization, with the participation of the medical staff, collects data on the medical necessity of procedures. 29. For ambulatory surgical centers that elect to use The Joint Commission deemed status option: The organization, with the participation of the medical staff, collects data on the appropriateness of care. Applicable to the ambulatory care, behavioral health care, critical access hospital, home care, hospital, laboratory, and long term care programs: 30. The hospital considers collecting data on the following: • Staff opinions and needs • Staff perceptions of risk to individuals • Staff suggestions for improving patient safety • Staff willingness to report adverse events Applicable to the behavioral health care program: 31. For foster care: The agency collects data on its performance, including the safety of the placement and the maintenance or improvement of the individual’s level of functioning. 32. For foster care: The agency collects data on the permanency of the placement and the permanency of outcome when they are within the organization’s scope of services. (continued)

15


Table A-2.

continued


Applicable to the home care program: 33. For hospices that elect to use The Joint Commission deemed status option: The governing body approves the frequency and detail of the data collection. 34. For hospices that elect to use The Joint Commission deemed status option: The hospice collects data on adverse patient events. 35. For DMEPOS suppliers serving Medicare beneficiaries: The organization seeks input from employees, beneficiaries, and referral sources when assessing the quality of its operations and services. Applicable to the ambulatory care program: 36. For ambulatory surgery centers that elect to use The Joint Commission deemed status option: The ambulatory surgical center documents the improvement projects it is conducting. The documentation includes, at a minimum, the reason(s) for implementing the project and a description of the project’s results. Applicable to the behavioral health care program 37. For opioid treatment programs: The program collects data about treatment outcomes and processes. Note: Examples of data collected include the following: • Use of illicit opioids, illegal drugs, and the problematic use of alcohol and prescription medications • Criminal activities and entry into the criminal justice system • Behaviors contributing to the spread of infectious diseases • Restoration of physical and mental health and functional status • Retention in treatment • Number of patients who are employed • Abstinence from drugs or abuse Applicable to the critical access hospital and hospital programs: 38. The hospital evaluates the effectiveness of all fall reduction activities including assessment, interventions, and education. Note: Examples of outcome indicators to use in the evaluation include number of falls and number and severity of fall-related injuries. 39. The hospital collects data on the effectiveness of its response to change or deterioration in a patient’s condition. Note: Measures may include length of stay, response time for responding to changes in vital signs, cardiopulmonary arrest, respiratory arrest, and mortality rates before and after implementation of an early intervention plan. Standard PI.02.01.01 The organization compiles and analyzes data. Elements of Performance 1. The hospital compiles data in usable formats. 2. The hospital identifies the frequency for data analysis. Applicable to the critical access hospital, hospital, laboratory, and long term care programs: 3. The hospital uses statistical tools and techniques to analyze and display data. Applicable to all programs: 4. The hospital analyzes and compares internal data over time to identify levels of performance, patterns, trends, and variations.

16

About This Book

Table A-2.

continued


Applicable to the behavioral health care and laboratory program: Note: Examples of external sources of information include the following: • Recent scientific, clinical, and management literature, including Sentinel Event Alerts • Practice guidelines or parameters • Performance measures • Reference databases • Other organizations with similar processes (Laboratory program: and standards that are periodically reviewed and revised) 5. The organization compares data with external sources, when available. Applicable to the hospital program: 6. The hospital analyzes data from ORYX core measures that, over three or more consecutive quarters for the same measure, identify the hospital as a negative outlier. Applicable to the critical access hospital and hospital program: 7. The hospital analyzes its organ procurement conversion rate data as provided by the organ procurement organization (OPO). Note: Conversion rate is defined as the number of actual organ donors over the number of eligible donors defined by the OPO, expressed as a percentage. 8. The hospital uses the results of data analysis to identify improvement opportunities. Applicable to the home care program: 10. For hospices that elect to use The Joint Commission deemed status option: The hospice uses the data collected to monitor the effectiveness and safety of services and the quality of care. Applicable to the ambulatory care program: 11. For ambulatory surgical centers that elect to use The Joint Commission deemed status option: The number and scope of distinct improvement projects conducted annually reflects the scope and complexity of the ambulatory surgical center’s services and operations. Standard PI.03.01.01 The organization improves performance on an ongoing basis. Elements of Performance 1. Leaders prioritize the identified improvement opportunities. 2. The organization takes action on improvement priorities. 3. The organization evaluates actions to confirm that they resulted in improvements. 4. The organization takes action when it does not achieve or sustain planned improvements. Applicable to the home care program: 8. For hospices that elect to use The Joint Commission deemed status option: The number and scope of annual performance improvement projects is based on the patients’ needs and internal organization needs. The projects reflect the scope, complexity, and past performance of the hospice’s services. 9. For hospices that elect to use The Joint Commission deemed status option: The hospice documents what performance improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on them.

17


Table A-2.

continued


Applicable to the ambulatory care program: 10. For ambulatory surgical centers that elect to use The Joint Commission deemed status option: The ambulatory surgical center implements preventive strategies throughout the facility targeting adverse patient events and makes certain that all staff are familiar with these strategies. Source: The Joint Commission: Comprehensive Accreditation Manual for Hospitals: The official Handbook. Oak Brook, IL: Joint Commission Resources, 2010.

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Chapter 1

Failure Mode and Effects Analysis Overview A

lthough the words failure mode and effects analysis (FMEA) may initially seem intimidating when strung together, the approach is a very straightforward and common-sense one that health care professionals can learn with ease. Offering an extremely powerful approach to proactive risk assessment and reduction, the technique involves an analysis to identify potential mistakes before they happen to determine whether the consequences of those mistakes would be tolerable or intolerable, then examining and redesigning processes to prevent and/or mitigate the effects of those mistakes. FMEA has been around for decades because it works.

A Step-by-Step Approach to FMEA In brief, FMEA is performed as follows: The responsible team identifies each step in a process or subprocess and the relationships between those process steps. The team then identifies potential failures involved in each process step, in terms of failure modes or symptoms. For each failure mode, the team studies the effect on the total process, as well as examines the interrelationship between the process being studied and other processes that could be affected by change. When potential effects are intolerable (such as those that threaten safety), the team makes plans to eliminate the possibility of error, stop an error, or minimize the consequences of an error. Then the team reviews and revises, as necessary, the action or actions being taken or implemented to minimize the probability or effect of failure. The FMEA technique is based on long-studied engineering principles and approaches to designing systems and processes, which include human factors analysis, formal systems analysis, and team training. The goal is to achieve optimal performance and proactively eliminate errors. Such approaches have also been useful and successful in a number of industries—for example, the airline industry’s development of a Crew Resource Management (CRM) program. CRM has been used throughout the airline industry to improve the operation of flight crews. The concept emphasizes the role of human factors in highstress, high-risk environments. It encompasses team training, simulation, and interactive group debriefings, as well as measurement and improvement of aircrew performance. 1 The goals of effective CRM are increased safety, efficiency, and customer satisfaction.

Step 1 Select a high-risk process and assemble a team.

Step 2 Diagram the process.

Step 3 Brainstorm potential failure modes and determine their effects.

Step 4 Prioritize failure modes.

Step 5 Identify root causes of failure modes.

Step 6 Redesign the process.

Step 7 Analyze and test the new process.

Step 8 Implement and monitor the redesigned process.

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Varying by the sources consulted, FMEA can involve from as few as four to as many as 10 different steps. The approach described in this book has the following eight key steps: 1. Select a high-risk process. 2. Assemble a team. 3. Diagram the process and brainstorm potential failure modes and their effects. 4. Prioritize failure modes. 5. Identify root causes of failure modes. 6. Redesign the process. 7. Analyze and test the new process. 8. Implement and monitor the redesigned process.

RCA and FMEA are interrelated. Each approach can be used during portions of the other approach. FMEA can be used during an RCA to help evaluate various proposed improvement strategies that resulted from the RCA. FMEA can look at where the various processes might fail and identify any new failure modes that have been introduced as a result of new process designs. RCA can be used to help identify processes that need FMEA and can more specifically determine the roots of an identified problem. In such a case, a full RCA is not required, but a critical look at how a failure could occur and what actions could be taken to prevent or mitigate the effects of the failure is appropriate.

A flowchart that provides more detail on the individual steps can be found in Figure 1-1 on page 21.

Analyzing processes after an event occurs must be done with a prospective look at what could go wrong with processes and procedures throughout the organization. If both tools are not used, the organization runs the risk of jumping from one retrospective analysis to another, responding to events as they occur rather than prospectively designing or redesigning processes to prevent bad things from happening. Chapter 5 provides more information about RCA as it relates to FMEA.

The ultimate goal of FMEA, when used in health care, is to prevent bad outcomes and ultimately prevent harm. The greatest strength of FMEA lies in its ability to focus users on the process of redesigning potentially problematic processes to prevent the occurrence of failures. FMEA can be effective at identifying system vulnerabilities, but it must be used as part of an ongoing, comprehensive quality improvement or performance improvement process in order to effect change. In other words, FMEA is an important tool in a health care organization’s performance improvement arsenal.

The Difference Between Root Cause Analysis and FMEA Root cause analysis, or RCA, is a technique that The Joint Commission and Joint Commission International require an accredited organization to use after a sentinel event has occurred to identify the event’s underlying causes. Whereas RCA is primarily a reactive approach to systems analysis, FMEA is primarily a proactive approach to the prevention of systems-related failures. Both are important tools for health care organizations as both are key to an organization’s performance. RCA and FMEA share the following characteristics: ■ Both must have the support of leadership. ■ Both have the goal of reducing the possibility of future harm. ■ Both involve identifying conditions that lead to harm. ■ Both are nonstatistical methods of analysis. ■ Both are team activities that require people, time, materials, and support.

20

Why Use FMEA? The fundamental reason health care organizations should conduct FMEA is that it has been proven to reduce the risk of error and increase the successful performance of a process. In health care, this could mean a decreased likelihood of a mistake occurring and improved safety. The safety of individuals receiving care, treatment, or services must be a priority for all health care organizations. The Joint Commission’s “Leadership” and “Improving Performance” chapters and Joint Commission International’s “Quality Improvement and Patient Safety” chapter provide a framework for helping to reduce the risk to and ensure the safety of individuals who receive care, treatment, or services in various health care settings. Through these chapters, leadership can define and implement a proactive system for identifying risk and reducing the risk of health care process or system failures that cause harm. For more information on the standards and requirements, see the applicable comprehensive or international accreditation manual that fits your organization’s needs and population served. Enhance Performance Safety is only one, albeit the most important, of many dimensions of performance. Process improvement made possible with FMEA can enhance numerous and, at times, perhaps all

Chapter 1: Failure Mode and Effects Analysis Overview

Figure 1-1 FMEA Flowchart

NGT=nominal group technique; RPN=risk priority number; SOD=severity, occurrence, detection; SME=subject matter expert. Source: Ramu G.: FMEA minus the pain. Qual Prog 36–42, Mar. 2009. Used with permission.

21


dimensions of an organization’s performance. For example, use of FMEA to improve the medication utilization process could enhance the efficacy and appropriateness of a medication regimen, the availability of medications needed in emergency situations and, thus, the timeliness with which nurses administer medications to individuals in need. FMEA could lead to improved effectiveness of the process by which a medication order is transcribed; the continuity of a care recipient’s medication history related to relevant practitioners; the safety of the individual receiving an error-prone, high-alert medication such as injectable potassium chloride or phosphate concentrate; and the efficiency with which medications are properly labeled in the pharmacy. Finally, FMEA could be used to improve the respect and caring an individual receives through effective pain medication management. Improvement of the safety dimension can sometimes negatively impact other dimensions; for example, timeliness is frequently negatively impacted by increased safety, because adding safety checks and balances to a system can increase the time needed to complete a particular task. The time added may be insignificant in some cases, but in others it can cause a greater impact. When considering changes based on the results of an FMEA, leadership will need to consider carefully and weigh the trade-offs between increased safety, timeliness, and affordability.

Improve Financial Performance FMEA involves a relatively small amount of time, resources, and finance when compared to the potential return on any investment in this technique. 2 Unlike many other tools, FMEA can yield significant results and financial savings without requiring complicated tools and statistical analysis. Evidence in engineering literature indicates that use of FMEA can help improve an organization’s financial performance. As performance data are collected about use of FMEA in health care organizations, bottom-line results may also be similarly impressive. As health care leaders are well aware, health care has several “bottom lines.” Financial performance is one; another is the safety of care recipients. It is unrealistic for organizations to expect FMEA to always yield a financial return on investment. Rather, the goal of proactive risk assessment is cost avoidance, not cost reduction. If potential process failures never actually occur, a sentinel event with cost implications to the organization may be avoided. 3 Enhance Team Approach Another key benefit of FMEA is its team orientation. Many health care organizations are growing accustomed to a teambased approach in their care areas, and teams that function well can accomplish more than individuals could separately. Additionally, studies show that well-functioning teams make fewer mistakes than do individuals. 4

Improve Quality Another key reason to conduct FMEA is that it is an effective quality improvement tool. FMEA narrows or eliminates gaps in quality and performance by helping identify areas where quality improvement is necessary. An organization can benefit when it incorporates FMEA into its quality management and performance improvement programs. The performance improvement program of an organization provides the data and information needed to accurately identify real or potential failure modes and improvement opportunities.

Teams also provide a powerful and often successful way to effect systemwide improvement. Use of FMEA by teams enhances communication, collaboration, and understanding organizationwide. At the same time, health care leaders need to recognize that a team-based activity requires people, resources, and time. To realize the benefits of FMEA, leadership must be willing to provide the time and people required to conduct FMEA in a thorough and credible manner.

Regularly conducting proactive risk analysis using a tool such as FMEA can help shift an organization’s culture from one of reaction and response to one of interactive risk management and error prevention. By moving toward multidisciplinary collaboration, which yields performance improvement projects that result in team-based processes and systems, an organization can reap the benefits of an open culture, in which errors are anticipated and addressed, staff feel valued, and individuals receive safe, high-quality care.

While FMEA is an effective tool, it is by no means perfect. There are several limitations to the approach, which an organization can overcome if it recognizes them. One of the significant limitations of the tool can also be seen as an opportunity: significant staff time and resources are typically needed to conduct FMEA, and organization leadership must be committed to providing those resources or the analysis is doomed to fail. However, by providing the resources, organization leaders can set the stage for collaborative, team-based quality improve-

22

Limitations of FMEA

Chapter 1: Failure Mode and Effects Analysis Overview

ment, which, in the long run, can have a huge impact on safety and quality in the organization. Another limitation of FMEA is that it cannot reveal the complete consequential and causal sets of any singular error or adverse outcome. An FMEA may appear to show that a specific error could cause a specific injury, but whether it would actually cause that injury requires analysis of the actions of all other persons and of all states of all systems and devices that might possibly be involved.5 FMEA should be used as a tool to anticipate possible problems and address hypothetical situations. In other words, it is not a predictor of failure so much as a formalized process of “what if.” FMEA allows a team to consider only one failure at a time. There is no logical process in the tool for considering multiple or interacting failures, and adverse events typically are the result of multiple failures and preexisting hazardous conditions. Thus, FMEA users will need to consider the interrelationships of failure modes. To help in this effort, other safety improvement techniques, such as a fault-tree analysis, should be used in conjunction with FMEA. Chapter 5 provides more information about fault-tree analysis.

Laying the Groundwork for Success Before diving into the FMEA process, it is important to lay the groundwork for successful results. The greater the thought given to relevant issues prior to commencing the FMEA, the greater the likelihood of its success. The following are five key elements to successful FMEA: 1. Leadership support. As mentioned earlier, leaders must be committed to the FMEA process as a proactive risk assessment. Leadership’s guidance in the importance of FMEA through providing the necessary resources, responding to findings, and encouraging the regular use of FMEA will help staff to view the process as not just extra work required by regulatory organizations. Resources that leadership must allot include the required people, time, materials, support (such as data analysis), and money. 2. A focus on and commitment to safety. This ensures the identification and improvement of processes that could present a safety risk to the individuals served by the organization. Processes that have the greatest potential to cause harm should be the primary focus for risk assessment. 3. Sustained and strategic performance improvement. Leaders must establish and maintain an environment that values performance improvement and uses FMEA results to help direct continuous and future improvement efforts. FMEA

must be an integral part of an overall quality management process or plan. A properly conducted FMEA will be confirmed by the measurement system. 4. Effective information management. The organization must be committed to obtaining, managing, and using information to improve outcomes. Effective FMEA depends on reliable and available data about the performance of processes and FMEA results. Data must be uniform, timely, and accurate, and procedures and processes must be well documented to reduce unnecessary variation. 5. Well-trained and qualified personnel. FMEA teams include individuals who are trained in the use of FMEA and other performance improvement techniques and tools and who are knowledgeable about the processes under study. Health care leaders and staff must try to anticipate any barriers they might encounter when conducting an FMEA and determine strategies to remove such barriers. Removing cultural barriers, such as not viewing FMEA solely as an initiative but as a performance improvement initiative, may be harder to address than process information/management barriers, such as having the data needed to analyze processes in depth. Sidebar 1-1, page 24, outlines common pitfalls and barriers to FMEA success. To this list could be added cultural barriers that exist when a “blame and shame” approach to problems exists in an organization. In such instances, organizations frequently focus their efforts on blaming individuals. The result is that staff may be unwilling to participate fully in FMEA, thereby limiting the approach’s usefulness. Chapter 2 addresses steps 1 and 2 of FMEA—choosing a process and assembling a team—the beginnings of any process improvement project.

23

Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction References

Sidebar 1-1.

Pitfalls to FMEA

Following are some of the common pitfalls experienced by teams conducting FMEA: • Conducting FMEA just to fulfill a requirement. The desire for improvement should come from within. If it is clear to team members that the FMEA is being conducted simply to fulfill an administrative obligation or comply with regulatory requirements, the full benefit of the analysis will not be realized. Team members should be passionate about the topic and about improving safety. • Choosing a process that is too complex . Many health care processes are made up of numerous smaller processes. Be sure that the team has chosen a project that is small enough or the project may become too unwieldy. • Inadequate representation among team members . The FMEA team should include staff who actually do the work being reviewed. It should also include a mix of management levels, departments, and clinical and administrative staff, to ensure that the team can develop a complete picture of the process. • Insufficient support from leadership. Without FMEA champions in leadership, the project may lack the staff and resources necessary to conduct the analysis and make the necessary system changes. • Wasting time on long debates . Some portions of the FMEA process, particularly risk prioritization, tend to spark very long discussions. Group leaders must be prepared to guide the team toward compromise, or table the discussion until another time. • Too little time for process redesign and implementation. FMEA can be a long process, and in the effort to finally make the system changes, team members may get overanxious in the effort to see results. However, process redesign and implementation can be one of the longest segments of the project, often taking months to complete. Be sure to take the necessary time to ensure that system changes are comprehensive and effective. Sources: Ramu G.: FMEA minus the pain. Qual Prog 36–42, Mar. 2009; Sheridan-Leos N., Schulmeister L., Hartranft S.: Failure Mode and Effect AnalysisTM: A technique to prevent chemotherapy errors. Clin J Onc Nurs 10:393–398, Jun. 2006; Spath P.: Worst practices used in conducting FMEA projects. Hosp Peer Rev 29:114–116, Aug. 2004.

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1. Pizzi L., Goldfarb N., Nash D.: Making health care safer: A critical analysis of patient safety practices. Evidence Report/Technology Assessment. No. 43. AHRQ Publication No. 01-E058, Jul. 2001. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/ptsafety/ (accessed Mar. 5, 2010). 2. Spath P.: Using failure mode and effects analysis to improve patient safety: Home study program. AORN J 78(1):16–37, Jul. 2003. 3. Salas E., et al.: The role of teamwork in the professional education of physicians: Current status and assessment recommendations. Jt Comm J Qual and Patient Safe (31)4:185–202, Apr. 2005. 4. Senders J.W.: FMEA and RCA: The mantras of modern risk management. Qual Saf Health Care 13(4):249–250, Aug. 2004. 5. Spath P.: Worst practices used in conducting FMEA projects. Hosp Peer Rev 29(8):114–116, Aug. 2004.

Chapter 2

Selecting a High-Risk Process and Assembling a Team T

he first step in performing failure mode and effects analysis (FMEA) is to select a process to investigate. FMEA can be used to improve many types of processes or subprocesses. Processes can fail if they are not initially designed well to provide the desired objectives or, more commonly, when the linkages between the steps in the process are not designed well or do not relate properly to one another.

So where should leadership focus their attention? High-risk care processes provide the natural starting place. These are processes in which a failure of some type will most likely jeopardize the safety of the individual receiving care. Selected processes may be new processes within the health care organization (for example, the process for accurately programming and operating a new infusion device), or they may be ongoing ones that potentially or actually are problematic (for example, the process for ordering and storing medical gases). They may be clinical in nature, relating directly to the provision of care, treatment, or services (for example, the restraint-use process), or nonclinically oriented, relating indirectly to the care received by individuals (for example, the process used to communicate test results to physicians and other care providers; or the orientation, training, and competence assessment of staff in identifying individuals at risk for falls). A portion of the process—or subprocess—could be particularly fraught with risk and, hence, could benefit from FMEA; for example, the blood unit labeling process might warrant FMEA within the overall blood transfusion process. Before a formal analysis has been conducted, organizational experience with processes can signal their high-risk status. While high-risk processes vary by health care setting or population, they are integrally related to the care and services provided, and therefore, they are associated with similar types of sentinel events in health care organizations that provide similar care and services. Health care leaders and staff should track these processes as part of their performance improvement efforts.

Characteristics of a High-Risk Process High-risk processes generally have one or more of the following characteristics1:









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Case Study Conducting FMEA on the Neonatal Intensive Care Unit Laboratory Test Ordering Process at Miami Valley Hospital Step 1: Select a high-risk process. Miami Valley Hospital, located in Dayton Ohio, is one of the city’s largest health care providers. The organization is the region’s only Level I trauma center and the birthplace of the most babies in the region. The neonatal intensive care unit nurses brought it to the attention of management and the NICU improvement committee that the process for ordering laboratory tests and receiving results in the neonatal intensive care unit (NICU) needed review. “We’d started using a new clinical system and ordering process, and the lab system it feeds used a system of batching that caused some confusion about how results were obtained and communicated back to caregivers,” says Maribeth Derringer, director of quality management. “As a result, labs were frequently being reordered when they weren’t necessary because the lab system batched these orders and they were waiting for an appropriate batch collection time.” Not only was this an inefficient use of staff time and resources, it also resulted in babies receiving more heel sticks than needed. In addition, there were concerns about bruising and whether the products being used for the sticks were the best. The organization decided to analyze the NICU lab process using FMEA. Step 2: Assemble the team. The team at Miami Valley Hospital consisted of the NICU nurse manager, the laboratory director, and some NICU bedside nurses, as well as core members of the NICU improvement committee, a group that oversees all process improvement projects in the NICU.

Variable input . In the health care arena, individuals who require care and services are the principal inputs to a process. Individuals’ variability is high: they may be very sick, have comorbidities, be receiving other treatments, or have differing care preferences. In addition, the staff caring for the individuals might be highly variable in terms of skill level and approach to the task. Health care processes, therefore, must accommodate the inevitable and uncontrollable variability of their principal inputs. ■ Complexity. Health care processes tend to be highly complex, with dozens of steps, which means they are particularly prone to failure. The greater the number of steps and handoffs or step linkages, the greater the probability that something will go wrong due to the interdependence of the parts and the whole. ■ Lack of standardization. Lack of standardization diminishes the likelihood that a process will be performed as desired. Individuals performing a process must carry out ■

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the steps in a consistent manner. Because health care inputs (the individual being served) are so variable and need to be accommodated, it is very difficult to achieve process consistency. Practice parameters, protocols, and clinical pathways all aim to reduce variation in how individuals perform the tasks in a process. ■ Tightly and loosely coupled processes. Tightly coupled processes have steps that follow one another in such rapid sequence that a variation occurring in one step cannot be responded to before the next step occurs. In fact, many times people may not recognize that an error has occurred until they are on the next step.2 In tightly coupled processes, delays in one step throw off the entire process, inputs generally are variable, and steps are nonstandardized. A failure in one step can lead to a “cascade of failures” as each following step attempts to handle an input it was not designed to handle and fails as a result; for example, in the operating room, an anesthesiologist works within a tight-

Chapter 2: Selecting a High-Risk Process and Assembling a Team

Figure 2-1 The Swiss Cheese Model of Error Occurrence Lack of supervision

Transfer guidelines

Improper ventilation technique

Communication

Individual develops acute resipiratory distress sydrome

Inadequate monitoring

Inadequate training and staffing skills mix

Creating safety at the sharp end or the arrow head also requires creating a learning culture supported by leaders whereby both reactive and proactive measures are used to guide continuous process and system improvements. Discrepancies, that are inevitable, occur between what is intended and what actually happens. James T. Reason’s Swiss Cheese Model illustrates that each slice of cheese represents various obstacles to the defense to acute respiratory distress syndrome. The holes in the cheese represent latent errors or a condition that when aligned with each slice creates system failures. Source: Modified from Reason J. T.: The Human Contribution: Unsafe Acts, Accidents, and Heroic Recoveries. England: Ashgate Publishing Limited, 2008, pg. 102. Used with permission.

ly coupled system that does not provide much slack or opportunity for recovery if one step in the process fails. Errors frequently occur at the point where one process or step overlaps or “hands off” to another. Loosely coupled processes, in contrast, are designed to tolerate process delays, permit change in the order of sequences, and provide alternative methods to achieve process goals. They also provide opportunities to identify failures and permit intervention to correct the problems and protect the individual receiving care. ■ Dependence on human factors. A high degree of dependence on human intervention within a process can lead to variation that could make the process prone to failure. Not all human-factor variation is bad, of course: when a process starts to fail or the process is “wrong” in some way

for a specific individual, humans can address and solve unanticipated consequences and adjust the process to avoid harm. This has been called “creating safety at the sharp end” (also see Figure 2-1 above). For example, the inconsistent use of abbreviations for drug dosages by practitioners can result in dosage-level medication errors. However, astute pharmacists, nurses, and other health care professionals can catch such an error before it reaches the care recipient. Their ability to do so depends on proper education and training and on regular assessment of their competence to perform a particular function within a process. ■ Tight and loose time constraints. Tight time constraints can be problematic for all types of processes. As the time required to perform a process is shortened, coupling

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between process steps is tightened even in an otherwise loosely coupled process. This makes it more difficult for someone to identify and respond appropriately to variation, thereby increasing the risk of failure. Loose time constraints can be equally problematic. When processes require too much time, those performing them may not be able to retain their focus. Boredom and distraction can contribute to process failure. In addition to the previously mentioned characteristics, highrisk processes are more likely to fail when conducted within an environment characterized by a hierarchical rather than teamoriented culture. A hierarchical culture is one in which staff are hesitant to communicate and collaborate with staff considered above or below them in the hierarchy. For example, a hierarchical culture can make nurses and other bedside care providers reluctant to raise concerns or question physicians and pharmacists about medications, dosages, and other elements of care. Medication ordering is frequently cited as an error-prone system due to organizational hierarchies. Some organization cultures, in fact, may create a hierarchical rather than team structure for the entire medication use process. Similarly, verification of surgical sites by surgical team members can suffer from hierarchical pressures. Language and jargon barriers coupled with a hierarchical culture can present a particularly dangerous scenario. The manner and degree to which staff communicates with each other while performing complex health care processes can affect the process positively or negatively.

Other Risk Areas to Consider High-risk processes are not the only ones that can lead to catastrophic failure and thus should not be the only processes examined for potential FMEA use. The following are some other types of processes to consider.

Low-Risk Processes That Add Up to Failure Small errors in processes can aggregate to produce catastrophic outcomes. A series of small errors can build up to create a serious problem. When examined individually, no single error is serious enough to do damage; however, when each error is taken into consideration, the impact is so great as to cause irreparable harm. Therefore, it is worth trying to fix minor system problems in order to prevent more serious outcomes. 3 Low-Frequency, High-Severity Errors When examining processes for potential FMEA use, health care organizations tend to overlook those processes with lowfrequency, high-severity outcomes. This is where the chances

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Tip: Leadership Responsibilities Leadership is responsible for the following: • Identifying individuals and services considered high risk in the health care organization • Prioritizing processes that will be addressed by FMEA • Using a collaborative process to develop relevant policies and procedures • Training staff in implementing the policies and procedures

of a failure in the process happening are very low, but the consequences of the failure are very high. In health care, these consequences may include death and/or disability; and avoidable deaths are not acceptable, however infrequent. Organizations must consider these types of processes when deciding what issues they are going to study. In addition, they must consider low-frequency, high-severity failures when analyzing the failure modes of a particular process. Chapter 4 provides more information on analysis of failure modes.

New Equipment or Service In addition to conducting FMEA on processes, organizations might want to conduct FMEA on new services or pieces of equipment before they “go live.” In this way, the organization can identify potential issues ahead of time and address them before the care recipient is directly affected. Ultimately, a health care organization should conduct FMEA or another similar proactive risk assessment technique any time there is a significant process redesign or introduction of a new service or piece of equipment.

New Building Design FMEA can be used when designing a new building or unit of a health care facility. Using FMEA, engineers and architects can literally build safety into the design of a structure. Designers can interview facility staff in order to understand the processes staff experience every day in providing care. The design should be customized to the people who work in the facility as well as processes conducted there. Most benefits of design are direct and measurable. They include the following: ■ Fewer injuries from falls by installing grab bars, reducing glare in rooms, and widening doorways ■ Reduced infections because of conveniently located hand washing stations and High Efficiency Particulate Air


Case Study Conducting FMEA to Prevent Pressure Ulcers at Gaylord Hospital

Step 1: Select a high-risk process. Gaylord Hospital is a not-for-profit, 137-bed, long term acute care hospital based in Wallingford, Connecticut. Admitting more than 1,000 patients per year, the hospital specializes in the care and treatment of medically complex patients, including those with stroke, spinal cord or brain injuries, complex wounds, neuromuscular disorders, and cardiac or respiratory problems. Although Gaylord has been licensed as a long term acute care hospital for decades, most of their patients were rehabilitation patients until a few years ago. “Our patients were mostly young and fairly healthy other than the trauma that brought them to us,” says Donna Trigilia, certified wound care nurse and coordinator of the wound care program. “These patients stayed with us for a few weeks before they were ready to be discharged. Then the population of patients began to change.” Increasingly, the patients being admitted to Gaylord were more medically complex—they were older, had more chronic diseases and multiple comorbidities, and were more likely to be dependent on mechanical ventilation. The population is now more likely to suffer from pressure ulcers. Because the hospital was not accustomed to this patient population, they did not have any formal protocols for prevention of pressure ulcers. In addition, a survey found that more than 40% of the patients were acquiring pressure ulcers during their stay. The organization decided to make changes and to conduct a FMEA to address this issue.

Step 2: Assemble the team. Because of the scope of this FMEA, the initial project team was large. It included a facilitator from the outcomes management department, the nursing director of admissions, a nursing assistant, a dietician, and representatives from pharmacy, physical therapy, infection prevention and control, information technology, and materials management. The medical director and the vice president of patient care services provided leadership support, which is vital to the success of any FMEA. As the project progressed, certain process experts were brought in as needed. For example, when the team worked through most of the system issues, the team was reduced to include clinical staff, and departments such as information technology or materials management were consulted when their expertise was required.

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(HEPA) Filter systems ■ Fewer medical and medication errors due to proper lighting and reduced noise levels ■ Higher levels of efficiency and morale among staff because of pleasant, bright work areas and convenient workstations and equipment

Sources for Identifying a Process to Analyze Organizations can look both internally and externally for ideas on what specific processes need attention and study using FMEA.

Internal Sources As mentioned earlier, organizations can conduct FMEA on just about any process. To determine areas that warrant FMEA, look to the following internal sources: ■ Performance improvement data. These data can come from a variety of sources, including risk management, utilization management, and quality control activities, as well as from infection prevention and control surveillance and reporting. Performance improvement data can help identify highrisk processes. Research data and morbidity and mortality data can also be useful. Using comparisons conducted internally over time with similar processes in other organizations or with external sources of information can help determine whether excessive variability or unacceptable levels of performance exist in processes and outcomes. ■ Individual receiving care and staff feedback. Staff in particular will be very aware of processes that are tedious or errorprone or that they continuously work around because of bad design. Encouraging staff to come forward and discuss problem processes can help identify some serious problem areas of which leadership is unaware. Sources for staff and the individual receiving care feedback may include surveys, focus groups, and leadership walkarounds. ■ Reporting systems. Developing voluntary reporting systems in which staff report errors, near misses, or processes that generally did not go according to plan can allow an organization to collect data on the potentially problematic issues that are occurring. For such a reporting system to be effective, staff must feel comfortable reporting, and it must be easy to do. Allowing staff to report via questionnaire, voice mail, e-mail, or other simple-to-use formats can help encourage staff to report issues. In addition to making it easy to report, leadership must commit to not “shooting the messenger,” but rather learning from the incident reported in order to prevent the problem from happen-

Tip: Sources for Identifying High-Risk Processes • Internal performance improvement data • Staff feedback • Customer feedback • Data from sister, parent, or similar organizations on a local, national, or international level • Professional organizations and associations • Safety organizations • Government/ministries of health • Association/society/professional literature • Sentinel Event Alerts • Liability insurance companies

ing again. Leadership should not automatically assume that an incident was caused because of someone being careless. Deeper system issues could be present that would be overlooked if blame were assumed. Once data are collected from a reporting system, the events should be coded so that problems can be examined in aggregate. This allows the organization to spot trends and patterns that need attention. The organization can also use certain quality improvement tools to help identify processes that are ripe for FMEA. For example, a Pareto chart is a type of bar chart that can be used to identify and call attention to a few vital areas or processes that cause some of the biggest problems. 4 Pareto charts can help reduce a huge process to a manageable size. High-problem areas would be reflected in the Pareto chart and thus provide more focus to the FMEA. Chapter 5 provides more information on Pareto charts.

External Sources Information disseminated from The Joint Commission’s Sentinel Event Database (see Table 2-1, page 31), The Joint Commission Sentinel Event Alerts, and Joint Commission International’s Sentinel Event Policy * (see Sidebar 2-1, page 33) can be helpful in making a proactive choice of a problem or an area for analysis. All types of health care organizations can experience sentinel events, including behavioral health facilities, long term care facilities, home care organizations, ambulatory care organizations, and clinical laboratories, in addition to hospitals. Organizations worldwide can learn about sentinel events linked to high-risk processes that occur with frequency, their root caus-

* All Joint Commission International accreditation manuals (except for the Joint Commission International Accreditation Standards for Medical Transport Organizations) have specific standards that relate to the management of sentinel events. For more information, see your current accreditation manual.

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Table 2-1. Sentinel Event Statistics Type of Sentinel Event

Number of Events

Percentages

Wrong site surgery

890

13.5%

Suicide

785

11.9%

Op/post-op complication

721

10.9%

Delay in treatment

557

8.4%

Medication error

535

8.1%

Falls

423

6.4%

Unintended retention of foreign body

330

5.0%

Assault/rape/homicide

251

3.8%

Perinatal death/loss of function

206

3.1%

Individual death/injury in restraints

200

3.0%

Transfusion error

144

2.2%

Infection-related event

141

2.1%

Medical equipment–related event

130

2.0%

Fire

100

1.5%

Elopement

94

1.4%

Anesthesia-related event

99

1.5%

Maternal death

87

1.3%

Ventilator death/injury

60

0.9%

Abduction

32

0.5%

Utility systems–related event

25

0.4%

Infant discharge to wrong family

8

0.1%

782

11.8%

Other less frequent types

The statistics above represent data that have been collected from 1995 through December 2009. The Joint Commission continually receives new data on sentinel events. For the most up-to-date information, as well as graphs showing trends in sentinel events and The Joint Commission’s Sentinel Event Alerts, visit the Joint Commission’s web site: http://www.jointcommission.org.

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Case Study Conducting Failure Mode and Effects Analysis on Medication Request Processes at Amerikan Hastanesi Step 1: Select a high-risk process. Amerikan Hastanesi, or American Hospital, is a 300-bed hospital in Istanbul, Turkey. In addition to inpatient services, the facility includes a 60-bed intensive care unit and 130,000 square feet of outpatient clinics. The staff includes 500 physicians, as well as 1,000 nurses, technicians, and medical and administrative support staff. The hospital has expanded its facilities and services, and its attention to patient safety issues has increased. Therefore, the hospital decided to conduct a FMEA on the preparation and distribution phases of the medication request process because medication safety is one of the main sources of medical errors, particularly in large facilities.

Step 2: Assemble a team.

The team members chosen for the FMEA project was selected based on the areas involved in the medication request process. Team members included the continuous quality improvement manager and staff, who initially educated the team on the FMEA process, the pharmacy manager and two pharmacists, nursing staff including a charge nurse and head nurse, and the patient safety officer, who served as the team leader and facilitator.

es, and possible risk-reduction strategies through The Joint Commission’s Sentinel Event Alert . For example, one issue of Sentinel Event Alert focused on reducing the risk of infant abductions and recommends that large maternity units focus on its infant–parent identification process. To reduce the risk of suicide, a behavioral health unit should focus on its suicide risk assessment process. In addition, health care organizations that are part of a larger network or system can obtain information about high-risk processes from their colleague organizations and parent organizations. Small organizations can network with other organizations locally, nationally, and internationally to obtain relevant data. Professional associations and organizations can also be an excellent source of information on high-risk, problem-prone processes experienced within specific health care fields. Literature available through such organizations and commercial publishers frequently includes information on problematic health care processes and case studies on how specific health care organizations have improved processes. Web sites of organizations specifically addressing safety and performance

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improvement can also provide particularly well-targeted information. An organization’s liability insurance company may also be a good source for information on high-risk processes. By looking at the types of processes that tend to be high risk for litigation claims, an organization may be able to identify an issue that could use improvement. 2 In addition, an organization’s chief financial officer can provide input on which organization risks have the greatest financial impact. Addressing the expensive risks may help gain support of leadership because ultimately there will be a cost benefit for the organization.

Making FMEA Manageable After processes and systems have been identified that would benefit from FMEA, how is it determined which ones are most in need of attention? In an ideal world, FMEA would be conducted with every process and subprocess that exists within a health care organization. In the real world, a choice needs to be made. How is this accomplished? One critical selection criterion is the process’s potential for having an adverse impact on the safety of the individual being


served. Leaders should ask and answer the question “Which process is most likely to affect the safety of the individual being served?” Two or three candidates may emerge. Continue to winnow the process by asking and answering the questions “Which process has the highest potential volume and, thus, the greatest likelihood for safety ramifications?” and “Which process is most interrelated to other health care processes and, thus, if problematic, is most likely to affect multiple processes?” When deciding which process to tackle, it is also important to choose one process that staff is interested in fixing. FMEA, while valuable, is a labor-intensive process, so without committed support from staff and leadership, FMEA is doomed to failure. FMEA is most effective when people are passionate about improving the process.5 In addition, when choosing a process to study, be careful not to take on too much. Targeting a complex process for FMEA might be a mistake because the sheer workload involved may cause inadequate analysis, staff burnout, and even anger among participants. Some processes may not seem complex until the team begins the diagramming process (covered in Chapter 3). For example, a FMEA team at a British hospital believed that mapping out its process for the outpatient parenteral antibiotic therapy service would be relatively simple and could be accomplished in one or two meetings. As the team diagrammed the process over the course of four two-hour meetings, it was discovered that the service consisted of 6 processes, 67 subprocesses, and 217 potential failures.6 The scope of an FMEA project should be limited and clearly defined so that everyone has a clear idea of what’s being studied and the project does not go on forever (define a start and end point). Limiting an FMEA to a subprocess of a more complex issue might be a way to reduce the FMEA to a manageable size. Focusing on a specific part of a complex process can keep the team on track and allow timely completion of the project without being overwhelming. 7 For example, choosing to study the entire medication administration process may be too broad; the complexity of the medication administration process might overwhelm an FMEA team and squelch any enthusiasm before the project even gets started. Instead, choose a particularly highrisk component of the medication administration process, such as the delivery of oral medications, or choose a particular medication to evaluate. This can bring the FMEA down to a more manageable size.5

Sidebar 2-1.

Joint Commission

International Sentinel Event Policy

In support of its mission to improve the safety and quality of health care provided to the international community, Joint Commission International reviews accredited organizations’ activities in response to sentinel events during the accreditation process. The following apply to sentinel events: • A sentinel event is an unanticipated occurrence involving death or major permanent loss of function unrelated to the natural course of the illness or underlying condition. • A sentinel event may occur due to wrong-site, wrongprocedure, or wrong-patient surgery. • Such events are called “sentinel” because they signal a need for immediate investigation and response. • The terms “sentinel event” and “medical error” are not synonymous; not all sentinel events occur because of an error and not all errors result in sentinel events. Goals of the Sentinel Event Policy

The policy has the following four goals: 1. To have a positive impact in improving care, treatment, and services and preventing sentinel events. 2. To focus the attention of an organization that has experienced a sentinel event on understanding the causes that underlie the event, and on changing the organization’s systems and processes to reduce the probability of such an event in the future. 3. To increase general knowledge about sentinel events, their causes, and strategies for prevention. 4. To maintain the confidence of the public and internationally accredited organizations in the accreditation process. Source: © 2010 Joint Commission International: Joint Commission International Standards for Hospitals, 4th Ed. Oak Brook, IL: Joint Commission Resources, 2010.

Assembling the FMEA Team Following the selection of a process to study, the FMEA team should be assembled. This is one of the most critical steps in the FMEA process. Without the right team members working together, the FMEA might not be effective and potentially

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might not accomplish its goals. An FMEA team should be multidisciplinary. This ensures that different perspectives or viewpoints are brought to the improvement process.

Identifying the Right Staff for the Job The selection of team members is critical. Teams limited in size to fewer than 10 individuals tend to perform with the greatest efficiency. Four to eight people may be the ideal size, but this depends on the size of the organization, the process being analyzed, and the areas it affects. The case studies featured in this book include successful FMEA teams between four members and more than 20 members. Team members should bring to the table a diverse mix of knowledge bases and should be knowledgeable about and committed to performance improvement. The team should include individuals with fundamental knowledge of the particular process involved. These are the subject matter or process experts. The team should also include representatives from areas that may be directly affected by changes in the process. These stakeholders will be the ones most affected by changes and will have the most at stake during the redesign. Areas indirectly affected by changes in the process should also be included. For example, a representative from nursing will most likely be included on most FMEA teams. The team might also include an individual with some distance from the process—perhaps someone who is not at all familiar with the process, but who possesses excellent analytical skills. Functioning perhaps as an advisor or a facilitator, this person can provide a fresh perspective, unencumbered by the classic “that’s how we’ve always done it” mentality. At least one individual with decision-making authority (a leader) and individuals critical to the implementation of anticipated process changes are needed as well. If several FMEA teams are needed to study portions of a large process, team members can overlap to facilitate integration of FMEA efforts and results. For example, consider the following process scenarios: ■ A FMEA team studying the restraint use process for adolescents might include a representative from educational services, a child care worker, a nurse, an administrative staff member, and a performance improvement or quality management staff member. ■ A FMEA team analyzing the resuscitation process for severe traumatic brain injury in the emergency department might include a neurosurgeon, an anesthesiologist, a trauma specialist, an intensive care unit nurse and manager/director, a respiratory therapist, a pharmacist, a pastoral

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Tip: Team Composition In drawing up a tentative list of team members, check to ensure that the team includes the following: • Individuals closest to the event or issues involved • Individuals critical to implementation of potential changes • A leader with a broad knowledge base, who is respected and credible • Someone who has decision-making authority • Individuals with diverse knowledge bases

counselor, a social worker, and a performance improvement or quality management staff member. ■ A FMEA team looking at a portion of the medication use process might include representatives from nursing, medicine, administration, the pharmacy or the pharmacy supplier, and information technology or management, as available. Give serious consideration to the roles assumed by team members. Successful FMEA teams typically are made up of at least the following roles: ■ Team leader. This person is knowledgeable, interested, and skilled both at group consensus building and using FMEA. The leader guides the team through FMEA while encouraging open communication and broad participation. This person does not have “the last word,” but instead leads the group to a consensus. ■ Facilitator. This can be the team leader but does not have to be. This individual should be skilled at being objective and moving the team along. Thus, it is best if the leader and facilitator are not stakeholders in the process being evaluated. The facilitator’s role is to guide the team through the process and sort out the less critical input from the contributions that affect safety. The facilitator can also help ensure that team members complete each step and document the results of the FMEA. Because of the critical role of the facilitator in keeping the team on track, it may be helpful to have a leader in this role that Tip: Team Member Roles • Leader • Facilitator • Recorder or scribe • Process experts • Representatives of specific health care disciplines


Case Study Conducting FMEA on the Opioid Prescribing Process at the University of Texas M.D. Anderson Cancer Center

Step 1: Select a high-risk process. The University of Texas M.D. Anderson Cancer Center, a National Comprehensive Cancer Network member institution, provides care to approximately 85,000 people per year, including 29,000 new patients. Management of cancer pain is a significant element of the care provided at M.D. Anderson Cancer Center and it often includes large doses of opioid medications; in 2008 the pharmacy dispensed 2.8 million doses of opioid medications. Sometimes called opiates, opioids are a class of narcotics that includes morphine, hydrocodone, oxycodone, codeine, and fentanyl, which are used for pain management. Opioids continue to be one of the top reported medications involved in errors. Errors with opioids have led to serious adverse events, such as allergic reactions, failure to control pain, oversedation, and respiratory depression (breathing difficulties leading to a lack of oxygen). The Institute for Safe Medication Practices has identified opioids as high-alert medications for this reason. More importantly, medication errors associated with opioids rank in the top three of all medication errors reported at M.D. Anderson Cancer Center. For these reasons, the department of quality improvement and patient safety accreditation chose the opioid prescribing process for the FMEA in 2008. It should be noted that the team initially chose to evaluate the prescribing, dispensing, administration, and monitoring of opioid therapy, but after team leaders attended an FMEA training workshop, they realized that the scope was far too broad. The team decided to focus on prescribing and made plans to address the other portions of the larger process in future FMEA projects.

Step 2: Assemble the team. With the opioid process narrowed down to the prescribing component, the FMEA project was still a significant undertaking as numerous disciplines are involved in the prescribing of opioids. After orienting such a large group to the FMEA process, the facilitators realized it would be more effective to divide the team into small subgroups specific to discipline. Three teams were created—nursing, pharmacy, and prescribers—so that each sub-team could address its branch of the process. The teams met separately and all three teams met as a whole for team meetings when necessary. Ginger Langley, clinical quality improvement consultant, and Virginia Gonzalez, accreditation coordinator, facilitated the project and coordinated meetings for all three teams. “When you have a large group of people involved in a project of this scope, it’s not a trivial amount of hours,” says Allen W. Burton, M.D., professor and chairman of the department of pain medicine, division of anesthesiology and critical care. “The leadership support we had was very important in making this happen.”

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team members feel comfortable with and will also take direction and input from this person when necessary. ■ Recorder. This person is responsible for taking notes or minutes during meetings and distributing these following each meeting. Many teams decide to rotate this function among all team members so that no one person has to take notes all the time. Taking notes can hamper a person’s ability to contribute fully to the meeting. ■ Process experts. These individuals are particularly familiar with the process under study. Individuals assuming this role on FMEA teams must be open to process change. If they are not, they can present barriers or obstacles to effective and efficient team functioning. ■ Representatives of specific health care disciplines. These individuals provide the multidisciplinary orientation that is critical to the FMEA team. Individuals “stand in” for their discipline. For example, the respiratory therapist on the FMEA team represents the interests and views of his or her respiratory therapy colleagues during team meetings. Different health care disciplines typically view the process from unique perspectives. Although these roles are all important, it is also critical that at least one member of the team be a champion for the effort. This individual believes fervently in the cause (in the case of FMEA, the improvement of a certain process) and can effectively motivate others through personal enthusiasm and initiative. It is most helpful when the champion is an individual with a measure of influence, such as an individual in a leadership role in the organization.

Leadership's Influence in Team Development Leaders lay the groundwork for effective team development by creating an environment that is conducive to improvement through team initiatives. Leaders must articulate their commitment to FMEA and empower the FMEA team to make changes or recommendations for improvement. In addition, participation of physicians and other medical staff members (as applicable to the care needs setting) on FMEA teams is critical. Leadership must understand the barriers to engaging the medical staff and take steps to overcome those barriers. In some organizations, this can be a cultural challenge. In a published case study, Carol E. Fletcher, Ph.D., R.N., comments on the challenges the nursing staff of one hospital faced in implementing improvements to reduce the risk of heparin administration errors 8: “For any meaningful reduction in errors involving medication administration [or other processes] to occur in the

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health care industry, a truly interdisciplinary approach is essential, including the willingness of physicians and hospital administrators to listen to the ideas and concerns of nurses and then act on those that are demonstrated to be logical and evidence-based. Culture can stop things dead in their tracks. You can have redesigned plans and processes that work well on paper but implementation may or may not go so smoothly, based on team participation,” notes Fletcher. Leadership must actively support improvements achieved through interdisciplinary teams.

Training the Team on How to Conduct FMEA What training should team members have before starting a FMEA? Team members need not be familiar with FMEA prior to starting the process. A leader or facilitator who is trained and knowledgeable about how to conduct a FMEA can guide team members through the process. He or she may want to give a brief “how to” lesson during the first meeting of the team. Team members should be familiar with how to contribute to and participate on an improvement team. Familiarity with performance or quality improvement tools and techniques, such as flowcharts, brainstorming, cause-and-effect diagrams, multivoting, and RCA, is also helpful.

Establishing the Team Mission, FMEA Scope, and Ground Rules Before the team begins to work, the leaders of the health care organization must establish the team’s mission and ground rules. Sidebar 2-2, page 37, provides a checklist of tips for FMEA team success. Consider the following: Is the team charged with the responsibility of conducting the FMEA and recommending improvements? Or is the team charged with the fuller mission of conducting the FMEA, recommending improvements, obtaining approval for the recommendations, and implementing and monitoring the approved improvements? Leaders must also determine whether the FMEA team needs to follow the improvement process used by other improvement teams. It is helpful for the team to know ahead of time whether there are any limitations to redesign efforts. For example, if the redesigned process requires expenditure, such as a new piece of equipment, is that something leadership is willing to support? If team mem-


bers are not given the parameters within which they must work, then valuable time can be wasted working on redesigns that are not currently possible for the organization. As mentioned previously, leaders provide the resources needed by the team, in the form of time, materials, support services, and money. They determine deadlines and outline how results should be communicated to others in the organization. Before the FMEA team meets for the first time, or at the first meeting, it is helpful to ensure that the scope of the FMEA is as accurately, clearly, and specifically defined as possible. One way leaders can perform this function is by putting in writing a simple statement (perhaps only one or two sentences) about the FMEA’s scope. The leader may work alone or through a team process. In either case, the FMEA team reviews the statement and discusses it until each team member understands it. If clarifications or revisions are required, they are documented in writing. In addition to the scope of the FMEA, the team should be provided with as much information about the current process as possible. For example, if data on the previous process problems are available, it is valuable to share those data with team members. This can help them understand why the project is important and any aspects of the process that require focused attention.2 Because a health care process is usually very complex and interrelates with or affects other health care processes, the leader might want to divide the process into subprocesses, define them, and assign subteams to work on each subprocess. For example, it might be done initially for individual subprocesses; these results can then be integrated to provide an FMEA for an entire process comprising many subprocesses.

Tip: Establish the Meeting Time The meeting time established for an FMEA team can have a major impact on the ability of some team

Sidebar 2-2.

Checklist of Tips for

Successful FMEA Teams ❑

Ensure that the team objective is well defined with established scope boundaries. ❑ Obtain a skilled and effective leader and facilitator for the FMEA team. ❑ Ensure visible top leadership support for team activities. ❑ Ensure that teams are multidisciplinary and include process owners and frontline staff. ❑ Emphasize, support, and monitor attendance. Management must support adequate time off from clinical duties for staff to attend FMEA meetings and compensation for meeting time. Overrecruit frontline staff to ensure that at least one person from every discipline attends each meeting. ❑ Assess baseline knowledge of the FMEA process and the process and/or technology to be evaluated. Train team members to assure adequate knowledge before or early in the team process. ❑ Inform team members of expected time commitment based on FMEA project scope. Long processes and technology evaluations will take months to complete. Plan related technology implementation for months after the FMEA team has completed its work to allow time for needed process and technology changes. ❑ Encourage and support communication and active participation among team members. Be aware of grouping and dominating team members. ❑ Monitor progress of FMEA team toward its goal. ❑ Evaluate outcomes of FMEA team, and develop lessons learned for future FMEA teams and similar team activities. Source: Wetterneck T.B., Hundt A.S., Carayon P.: FMEA team performance in health care: A qualitative analysis of team member perceptions. J Patient Saf 5:102–108, Jun. 2009. Used with permission.

members to participate and, thus, should be carefully considered. For example, to accommodate multiple shifts in some health care settings, organizations choose to hold meetings in the evening. Night-shift staff can come to work early for the meeting, afternoon-shift staff can stay late, and day-shift staff can return to the organization for the evening meeting. This can work only if leadership addresses the staffing issues associated with this, such as overtime pay for extra hours.

Using a Checklist Use of a checklist or form can be very helpful during the preliminary startup phases of FMEA ( see Figure 2-2, page 38). A checklist is one of the easiest tools teams can use to identify various options, needs, or resources. It is most valuable early in the FMEA process, to ensure that the team’s purpose is clearly defined and that the FMEA proceeds smoothly during the crucial preliminary stages. A checklist can be particularly helpful

37


Figure 2-2 FMEA Team Start-Up Worksheet FMEA Number: ___________________________________________________________ Date Started: _____________________________________________________________ Date Completed: __________________________________________________________ Team Members: __________________________________________________________ ________________________________________________________________________ Leader: _________________________________________________________________ Who will take minutes and maintain records? __________________________________ 1. What is the scope of the FMEA? Include a clear definition of the process or product to be studied. ____________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ 2. Are all affected areas represented? (circle one) YES NO Action:______________________________________________________ 3. Are different levels and types of knowledge represented on the team? (circle one) YES NO Action:______________________________________________________ 4. Are customers or suppliers involved? (circle one) YES NO Action:______________________________________________________ 5. What aspect of the FMEA is the team responsible for? (circle one) FMEA Analysis Recommendations for Improvement Implementation of Improvements 6. What is the budget for the FMEA? _________________________________________ 7. Does the project have a deadline? _________________________________________ 8. Do team members have specific time constraints? ____________________________ _____________________________________________________________________ 9. What is the procedure if the team needs to expand beyond these boundaries? ______ _____________________________________________________________________ 10. How should the FMEA be communicated to others? ___________________________ _____________________________________________________________________ Source: McDermott R.E., Mikulak R.J., Beauregard M.R.: The Basics of FMEA. New York: Productivity Press, 2009, p. 17. Used with permission.

shortly after FMEA teams are chartered. At that point, checklist questions focus on the breadth, scope, mission, and ground rules of the assembled team. Relevant questions include the following: ■ Has the scope of the FMEA been clearly defined? ■ Does the team know what its mission is? ■ Is there a team member for each key department or discipline affected by the process being analyzed?

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Does the team include individuals who are critical to implementing potential changes, a leader with a broad knowledge base, an individual(s) with decision-making authority, and individuals with diverse skills and knowledge? ■ Has the team identified the required resources? ■ Is the team aware of the expected time frame for completing the FMEA? ■ Does the team know how its results should be communicated and to whom? ■


To create a checklist, your team can do the following: ■ Assign a team facilitator or leader to draft a checklist. This gives the team something to react to. ■ Ask for input in customizing the list and revise it accordingly. ■ Frame all questions to elicit positive answers as go-ahead signals. ■ Work through the questions one at a time, until it reaches a consensus on each. ■ Proceed with the FMEA only when it can answer “yes” to each yes/no question. Once a general checklist for FMEA has been created, use it as a tool to help prepare for future FMEAs.

Establishing the Rules of the Road At the first team meeting, the FMEA team leader needs to establish ground rules that will help the team avoid distractions and detours on the route to improvement. The following ground rules provide a framework that allows teams to function smoothly: ■ Decision making. The group must decide what kind of consensus or majority is needed for a decision, recognizing that decisions belong to the entire team. ■ Attendance. Attendance is crucial. Constant late arrivals and absences can sabotage the team’s efforts. It is important to set guidelines for attendance. Unlike committees that meet for a long period of time for an ongoing purpose, an FMEA team meets on an ad-hoc basis for shorter periods. When the FMEA is completed, the team can disband. ■ Meeting schedule. For high attendance and steady progress, the team should agree on a regular day, time, and place for meetings. These matters should be revisited at various times throughout the process. ■ Opportunity to speak. By agreeing at the outset to give all members an opportunity to contribute and to be heard with respect, the team can focus its attention on the important areas for open communication. ■ Disagreements. The team must agree to disagree. It must acknowledge and accept that members will openly debate differences in viewpoint. It is fine for discussions to continue outside the meeting room, but members must feel free to express in a meeting what they articulate in the hallway. Team members should commit to resolving issues or letting them go. Some teams adhere to a 24- to 48-hour deadline for conflict resolution. ■ Assignments. Team members must agree to complete assignments within particular time limits so that delayed work from an individual does not delay the group. A level

■

of accountability should be established for team members so that assignments do not get pushed aside when the team member returns to his or her regular duties. The efforts of one team member will directly affect the efforts of other team members. Other rules. The team needs to discuss all other rules that members feel are important. These can include whether senior management staff can drop in, whether pagers and cell phones should be checked at the door, what the break frequency is, and so on.

Setting the tone early on of how the team will interact is important to the team’s success. Team members should be encouraged to openly communicate with each other and discuss issues and differences in a constructive way. One particular dynamic that is critical to successful teams is the issue of trust. Teams that trust each other are more likely to get things accomplished than those that do not. Now that the process and team have been chosen, it is time to begin analyzing the process. Chapter 3 will discuss how to conduct this step of the FMEA.

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Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction References 1. Croteau R.J., Schyve P.M.: Proactively error-proofing health care processes. In Spath P. (ed.): Error Reduction in Health Care. San Francisco: Jossey-Bass Publishers, 2000, pgs. 178–198. 2. Spath P.: Home study program: Using failure mode and effects analysis to improve patient safety. AORN J 78:15–44, Jul. 2003. 3. Smith M.: To assume is human. Physician Exec pgs. 56–58, May/Jun. 2004. 4. FMEA: A new QI tool to help improve case management processes. Hosp Case Manag 11:33–48, Mar. 2003. 5. Spath P.: Worst practices used in conducting FMEA projects. Hosp Peer Rev 29:114–116, Aug. 2004. 6. Gilchrist M., Franklin B.D., Patel J.P.: An outpatient parenteral antibiotic therapy (OPAT) map to identify risks association with an OPAT service. J Antimicrob Chemother 62:177–183, 2008. 7. De Rosier J., et al.: Using Health Care Failure Mode and Effect Analysis™: The VA National Center for Patient Safety’s proactive risk analysis system. Jt Comm J Qual Improv 28:248–267, May 2002. 8. Fletcher C.E.: The need to address hospital politics in order to reduce medication errors: A case study. Policy Polit Nurs Pract 3:66–72, Feb. 2002.

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Chapter 3

Diagramming the Process and Brainstorming Potential Failure Modes Diagramming the Process The next step in failure mode and effects analysis (FMEA) is to review the process in full by describing or diagramming it in a graphical format. Multidisciplinary participation of FMEA team members and all others involved in the process is vital to the identification of each and every step of the process, which may be more complex than previously thought. Each team member must thoroughly understand the process and its component subprocesses, as applicable. Team members should also understand the interrelationships between the selected process and other care processes. FMEA teams might want to draw on various individuals who have expertise related to selected steps or processes. Teams might find that the process seems too large and complex to manage in one diagram. Breaking the process into component subprocesses and diagramming each of them may be helpful. Using an interrelationship diagram that shows how the selected process relates to other care processes can also be a helpful way to ensure that the team considers process relationships throughout the FMEA. When diagramming, team members should ask themselves the following questions: ■ What are the steps in the process? If it is an existing process, how does it currently occur and how should it occur? If it is a new process, how should it occur? ■ How are the steps interrelated? (For example, are they sequential or do they occur simultaneously?) ■ How is the process related to other care processes? ■ What tools should we use to diagram the process? Allow plenty of time for this process and do not rush this step. Teams need time to illustrate the process in as detailed and complete a manner as possible. The more detailed the diagram, the more effective it will be. Keep in mind that difficulties are likely to be encountered during the diagramming process. These probably reflect confusion about the process. The team can work through conflicting and confusing points to reach a resolution.









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Figure 3-1 Flowchart Symbols

Process

Document

Document

Predefined process

Decision

Manual imput

Data

Manual operation

Connector

Merge

Extract

Flow lines

Symbols that are commonly used in flowcharts.

Commonly Used: The Flowchart Flowcharts (or process maps) are perhaps the most commonly used tool for helping teams understand the steps in a process. One of the oldest quality improvement tools, a flowchart is a graphic representation of the path a process follows (or should follow) from start to finish. A flowchart can depict the sequence of steps as designed and as actually performed. These often are not the same. The team might want to create two separate flowcharts: one that outlines how the process is intended to occur as defined by policies and procedures, and one that follows the

42

process as it usually occurs in normal circumstances. By comparing the two charts, the team can more easily identify redundancies, inefficiencies, misunderstandings, waiting loops, and decision points, all of which can create process failures. During the process design or redesign stage, a flowchart can also be used to show the desired path the new or redesigned process is to follow. Symbols used in traditional flowcharts generally are consistent (with only minor variations) and easy to learn ( see Figure 3-1 above). Flowcharting software, which is readily available on

Chapter 3: Diagramming the Process and Brainstorming Potential Failure Modes

Case Study

Conducting FMEA on the Neonatal Intensive Care Unit Laboratory Test Ordering Process at Miami Valley Hospital

Step 3: Diagram the process and brainstorm potential failure modes. The team discussed the process and then one member created a flowchart based on that information. The flowchart was then presented to the group for critique and fine-tuning. Physician writes order

Physician returns chart to desk

HUC enters order into EPIC

HUC signs paper order and places chart out in rack

RN compares paper chart to EPIC

RN acknowledges orders in EPIC

RN acknowledges orders in EPIC

Lab receives and interprets EPIC order

Lab collects specimen

Lab collect?

Nurse collects specimen

Lab conducts analysis

Lab enters results into EPIC (continued)

43


Case Study

Conducting FMEA on the Neonatal Intensive Care Unit Laboratory Test Ordering Process at Miami Valley Hospital, continued

When the flowchart was finalized, the group went through each step to identify failure modes. Process Component

Failure Mode

1.

1A. Unable to read orders

Physician writes order

1B. Previous order not discontinued 1C. Duplication of orders 1D. Write order for wrong baby 2.

Physician returns chart to desk

2A. Chart not collected 2B. Chart not returned

3.

Health unit coordinator (HUC) enters order into system

3A. Order not entered 3B. Wrong lab entered 3C. Enter order for wrong day 3D. Enter order for wrong baby 3E. Order not entered as written by physician 3F. Lab order not customized 3G. Orders entered different ways by different HUCs 3H. Multitasking and distractions

4.

HUC signs paper order and places chart in out rack

4A. Paper record not in chart

5.

Nurse compares paper chart to computerized record

5A. Chart order not compared to computerized order 5B. Nurse does not view computerized orders

6.

Nurse acknowledges orders in computer system

6A. Nurse does not acknowledge orders properly

7.

Lab receives and interprets electronic order

7A. Lab tech does not receive intended information

8.

Nurse or lab collects specimen

8A. B aby is stuck unnecessarily

9.

Lab conducts analysis

None identified

10. Lab enters results into computer system

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None identified


Sidebar 3-1.

Steps for Creating a Flowchart

Teams can approach the creation of a flowchart in a number of different ways. The following are five possible steps that teams can follow: 1. Establish starting and ending points of the process . This will help the team contain the chart within manageable boundaries. The team may decide, however, to change the boundaries later if the process proves to be two or three processes in one, for example. 2. Brainstorm activities and decision points in the process. Brainstorming should be done by those most familiar with the various steps in the process, usually the direct caregivers, with assistance as necessary from people outside the team. At this stage, the team is looking for specific activities and decisions necessary to keep the process moving to its conclusion. When considering how the process actually is performed, teams should consider caregiver-to-caregiver, unit-tounit, and/or shift-to-shift variations. 3. Determine the sequence of activities and decisions. Once the activities and decision points are gathered, the team must determine their sequence. This is often not as easy as it sounds. Some activities may appear to occur simultaneously, while others may seem disconnected, or certain decisions may cause steps to be repeated; however, these flaws in the process must be included in the flowchart. A valuable exercise is to use adhesive notes placed on a wall to experiment with sequence until the appropriate one is determined. If the sequencing of steps seems daunting and confusing, the team may want to create a simple high-level flowchart containing only the most basic components. Then go back and add in the detail. 4. Use the information to create the flowchart. If creating a traditional flowchart, the team should place each activity in a box and place each decision point in a diamond. Connect these with lines and arrows to indicate the flow of the process. Some teams find it helpful to number each step consecutively (1, 2, 3, and so on) and to do likewise with all substeps (1a, 1b, and so on). 5.Analyze the flowchart. The team needs to look for unnecessary steps, redundancies, barriers, and any other difficulties; team members may notice these issues during the creation of the flowchart, but they should not be discussed in detail until this point. The team may also want to find spots where the process works well and consider these as models for improvement.

the Internet, can facilitate use of appropriate symbols and the flowcharting process as a whole. Another type of flowchart teams might want to use is called an event line . This type of flowchart does not use all the symbols found in traditional flowcharts. It consists of boxes that contain each of the steps involved in a process with arrows that connect them. To maximize the time of team participants, leaders can choose to develop an initial draft of a flowchart before the first FMEA team meeting. This gives the team something to react to and can provide a starting place for discussion. However, regardless of whether an initial draft of the flowchart is available, the existence of each and every step must be confirmed and verified, and the draft flowchart should be tweaked, finalized, and approved by the team as a whole. For more on how to create a flowchart, see Sidebar 3-1 above. An example of a completed flowchart is provided in Figures 3-2 and 3-3, pages 46–47.

Avoiding Common Mistakes Several of the following strategies can help teams avoid common mistakes when diagramming a process 1: ■ Ensure that the flowchart is constructed with help from the individuals actually performing the work being charted so that it reflects reality. ■ If the process seems too complicated to be flowcharted on one or two pages, break the overall process down into manageable chunks or subprocesses and create a flowchart for each of these. Teams should recognize, however, that there are some risks associated with doing this. The linkages between the subprocess steps must not be forgotten. For example, a team that diagrams the subprocesses within the medication use process cannot forget the linkages between the medication prescribing process and the preparing and dispensing processes. Failures can occur in numerous ways during this handoff—for example, when the order is entered into the computer system, when the pharmacy staff calls the prescriber to verify an order, or 45


Figure 3-2 Example Flowchart: Radiation Treatment Planning Process

Place calculation points

yes

Generate treatment plan

Plan acceptable to dosimetrist & M.D.?

no

Planning PDFs sent to eChart

PDF reports of DRR sent to eChart

Compose treatment plan document

Plan exported

Compose treatment DRR document

Export DRR

Export QA data IMRT dose plane

Plan exported into patient D&I

Associate DRR with appopriate fields

Tx calendar setup

M.D. reviews final plan and prescription

no

R&V = record and verify; Tx = treatment; IMRT = intensity-modulated radiation therapy; TP = treatment plan; D&I = diagnosis and intervention; QCL = quality checklists.

yes

M.D. approve TP planning document and prescription

This figure shows the flowchart process for production and handling of digitally reconstructed radiographs (DRR) in the radiation treatment planning process. Source: © 2010 Eric Ford, PhD. Used with permission.

when a prescriber clarifies or changes an order. ■ Be sure that all process and subprocess steps are identified before proceeding. If a team fails to identify all the steps, it will not be successful in identifying failure modes, their root causes, and relevant process redesign strategies. ■ Although developing a flowchart is the most common way of diagramming a process, teams can use other methods. For example, list the steps in a process, place a number by each step, and organize the steps in order of occurrence. Or create a block diagram of the product or process. A block diagram shows major components or process steps

46

as blocks connected together by lines that describe how the process components or steps are related. The diagram shows the logical relationships between steps and establishes a structure around which the FMEA can be developed.

Walk Through the Process It can be very beneficial to walk through the process under discussion. This exercise allows the team to identify how the process actually occurs. Walking through the process can help assist with creating the flowchart, and after the initial flow-


Figure 3-3 Example Process Map: Medication Reconciliation Process

chart is created, it can help verify each step, its sequence, and any variations in its day-to-day performance.

wrong and thereby helps the group start to identify some of the failure modes.

Individuals with expertise related to each step can verify the sequencing of the step, the proximate decision points, and the handoff or linkage to the next step. Walking through the process as it actually occurs helps identify the difference between the intended process and the actual process. Processes do not necessarily occur as designed. Changes in steps and their sequence may occur for any number of reasons, such as staffing, competence, and care population. Walking through the process provides the team with clues about what could go

Identify Potential Failure Modes After the diagram of the process has been created and verified by the team, it is time to begin the task of identifying failure modes. A failure mode is any event that is the cause of a functional failure. This must be distinguished from the failed state of a process or system, which is the effect of a failure mode. 2 Any step in a process can fail, and each failure may have many failure modes.

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Identifying failure modes requires team members to think “outside the box”—beyond the normal scope of everyday practice and vision. It means trying to do such things as generalizing, broadening, and removing the constraints with which one normally approaches a task. It involves thinking of the process as a system and focusing on the relationship of the parts to a whole. Although human nature is inclined to break down large problems into smaller manageable parts, the challenge is to retain the ability to see the big picture as the focus shifts to individual processes. Brainstorming Potential Failure Modes

Brainstorming is a structured and creative process that a group of people use to generate as many ideas as possible in a minimal amount of time. Brainstorming stimulates creativity and encourages many perspectives on an issue. If properly conducted, brainstorming provides a safe environment for team members to express ideas, and it can strengthen the team as a whole. Brainstorming is not an end in itself. The ideas generated through the process have to be assessed and refined. However, brainstorming is a start—a way of moving toward an identified goal of process improvement. The objective of brainstorming potential failure modes is to identify, within a finite period of time, as many ways as possible that a process can fail, both at each step in the process and in the linkages between the steps. Establishing Ground Rules

The ground rules for brainstorming sessions should be established before the actual session is conducted so that all participants will understand them. Some experts suggest that the best way to have meaningful ground rules is to have the team create its own. Perform a mini-brainstorming session around creating brainstorming ground rules. This should provide an opportunity to practice the skills necessary for an effective brainstorming session. Then post the rules so that they are visible to all in the room and can be enforced without making enforcement feel personal. 3 Planning for a brainstorming session is critical. Poorly planned sessions can be more harmful than helpful. Leaders should give serious consideration to the space in which the brainstorming session is held. Is it a nonthreatening, safe environment for expressing ideas? Can a door be shut to provide privacy and minimize distraction or interruption from those passing by? What materials will be needed? Who will be the scribe? This needs to be someone who can write down ideas very quickly, legibly, and accurately so that the flow of ideas is not hampered.

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Tip: Brainstorming Ground Rules • There is no such thing as a bad idea. All ideas are valuable, as long as they address the subject at hand. The leader should express this as part of his or her introductory comments. • Quantity, not quality, is the goal. More ideas are better. Build on each other’s ideas. • Never criticize other people’s ideas. It is crucial that neither the leader nor the other group members comment on or react to any given idea. Remember that the best ideas are sometimes the most unusual. • Only one person should talk at a time. • Do not interrupt someone offering an idea. • Post the ground rules on the wall so that no one will feel personally challenged when he or she breaks a rule.

Steps in the Brainstorming Process Effective brainstorming can be accomplished in the following five basic steps: 1. Define the subject of the brainstorming session. This ensures that the session will have direction and that ideas will not be too dispersed to be useful. Make sure that everyone understands the focus before ideas start flowing. Limit brainstorming to one “level” or process step at a time. 2. Think briefly about the issue. Allow enough time for team members to gather their thoughts but not enough time for detailed analysis. Do not give the team time to secondguess their ideas. Be aware that self-censorship will stifle creative thought. 3. Set a time limit. There should be enough time for every member to make a contribution, but keep it short to prevent premature analysis of ideas. A time limit of 10 to 20 minutes for generating a list of potential failure modes with each step and handoff may be appropriate and effective. 4. Generate ideas. A team can use a structured format in which the members express ideas by taking turns in a predetermined order, and the process continues in rotation until either time runs out or ideas are exhausted or an unstructured format in which group members voice ideas as they come to mind. The scribe should write down all ideas on a chalkboard or easel so that the group can view them. In addition to recording the ideas on a chalkboard or easel for easy viewing, consider recording ideas on a laptop computer. This allows the scribe to send a document containing all the ideas to each team member immediately following the brainstorming session. It also creates a document from


Case Study

Conducting FMEA on the Psychosocial Assessment Completion Process at Health Care for the Homeless (HCH)

Step 3: Diagram the process and brainstorm potential failure modes. To outline the process, the HCH team used an online FMEA tool. “It was much easier than paper and pencil,” says Ed Geraty, director of performance improvement. “It walks you through the steps interactively and helps make sure you don’t leave anything out. I recommend using a computerized tool.” The result is an event line flowchart. Client sees therapist case manager (TCM) for first time

Initial mental health assessment completed

Schedule follow-up appointment to state psychosocial assessment

Client comes in for second appointment

TCM copies demographic data from encounter sheet to psychosocial

Interviews client to gather data to complete assessment

If client needs benefits/insurance, TCM educates client on the process

If external referral is given, written information is given to client

If internal referral is given, appointment is put into database

TCM makes follow-up appointment

TCM provides mental health diagnosis

TCM signs assessment

TCM files assessment in assessment section of chart After identif After identifying ying the the steps, steps, the the team team determin determined ed potentia potentiall failures failures and found found that that each each of the the 13 steps steps,, no matter matter how simple simple one might seem, had one potential failure mode. 49


which the the team can can work to further further refine refine the the FMEA and and makes the next step of grouping ideas more efficient. Number the ideas so that the next process of grouping ideas into categories is easier. Numbering also provides a goal—for example, trying to get to 10 ideas about what could go wrong at each step. Record exactly what is said. In organizations where team members may not regularly be in a centralized location, brainstorming can be done by asking team members and other staff to submit as many ideas as possible about the topic in writing, by voice mail, or by e-mail. 5. Clarify ideas. The goal is to make sure that all ideas are recorded accurately and are understood by the group—not judged judge d or analyz analyzed. ed. Clarif Clarificatio ications ns takes place only after everyone is out of ideas. Do not attempt to remove duplication, put the ideas in sequence, or rank them at this point. When brainstorming is through, the team should have a varied list, not a refined list. When brainsto brainstorming rming failur failuree modes, modes, teams teams can conside considerr the folfollowing elements: ■ People (for example, staffing level, training, scheduling, communication, or competence assessment issues) ■ Materials (for example, issues related to availability of supplies or misplaced supplies) ■ Equipment (for example, issues related to availability of appropriate equipment) ■ Methods (for example, issues related to the processes and procedures that staff use) ■ Environment (for example, issues related to the safety of the environment, such as infection prevention and control or hazardous waste) Depending on the complexity of the process chosen for FMEA, a series of brainstorming sessions, each devoted to one of these elements or a defined process step or steps, could be appropriate. Things could go wrong in any one of several areas. A focus on each one ensures the creation of as thorough a brainstorming idea list as possible. Differences between the intended process and the actual process may have been identified during the flowcharting process. These provide a way to get started. Some failure modes may already have occurred within the organization but may not have caused any problems yet. If allowed to persist, they might, in combination with other process failures, cause harm. Identification of risk points can often yield a good failure mode list. Failure modes often occur at risk points. Risk points are

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those specific places in a process or system that are susceptible to error or system breakdown. They generally result from a flaw in the initial design of the process or system, a high degree of dependence on communication, nonstandardized processes or systems, and failure or absence of backup. For example, during preoperative procedures, verification of the body side and part to be operated on constitutes a risk point. When consid considering ering possib possible le failure failure mode modes, s, teams teams should reme rememmber to think about the following active and latent conditions definitions4: Active ve failu failures res are defin defined ed as errors errors and viola violations tions that occur ■ Acti at the point of direct interaction between a human and a system. These include errors made by all caregivers who are involved in the day-to-day care activities. The effects of active failures are generally immediate and readily apparent. ■ Latent conditions are more insidious and can often go unrecognized. They are the consequences of decisions made in the leadership levels of an organization and could stem from several sources, including resource allocation, education and training, and other managerial decisions. It is important to consider both types of failure because they can both lead to adverse consequences.

Using Additional Resources Ideas generated by the team through the brainstorming process provide a starting place for determining failure modes. Yet team ideas need not constitute the only resources tapped. Other internal resources include leaders and staff not on the FMEA team, individuals receiving care by the organization, and other people who come in conta contact ct with the organ organizatio ization n (such as a fami family ly member or friend of the individual receiving care) that may be able to offer a unique perspective. Diversity of viewpoints can offer valuable insight into what could go wrong at various steps of a process. Staff and care recipient satisfaction surveys, risk management reports, and performance or quality improvement data can also provide helpful insight about potential failure modes and their effects.

Grouping Ideas into Categories After all the ideas about what could go wrong (the failur After failuree modes) are out on the table, the FMEA team will want to organize or group ideas into relevant categories. This ensures that the team can stay focused without jumping from one type of failure to another. Similar ideas will be categorized according to whatever categories make sense to the team. Ideas may overlap and be so similar that they need to be combined or consolidated.


Case Study

Conducting FMEA on the Opioid Prescribing Process at University of Texas M.D. Anderson Cancer Center

Step 3: Diagram the process and brainstorm potential failure modes. Each of the three teams developed a flowchart for their own piece of the process, and the facilitators worked to put those pieces together. The teams then individually considered the failure modes. “It was valuable for the people in each discipline to work with their peers,” says Ginger Langley, clinical quality improvement consultant in medication safety. “People were more open and honest about where the failures were likely to happen when they weren’t with people from the other areas.”

( continued ) continued An affinity diagram is one tool tool that can can help the team creativecreatively organize a large number of ideas into relevant groupings. It provides structure and organization of issues when chaos seems to exist. Following the brainstorming session, the FMEA team might have multiple sheets of paper or chalkboards listing ideas. An affinity diagram can help shape these into something with which the team can cope. An affinity diagram can either

add structure to a large or complicated issue or break down a complicated issue into broad categories. Both functions are useful in this case. Most descriptions of how to construct an affinity diagram include seven steps. The first three steps—choose the team, define the issue, and brainstorm the issue and record the

51


Case Study

Conducting FMEA on the Opioid Prescribing Process at University of Texas M.D. Anderson Cancer Center, continued

ideas—will already have taken place as a part of the brainstorming process described earlier. The team then takes the following four steps: 1. Transfer all the ideas onto index cards or adhesive notes, one idea per card or note. Make sure that each idea is expressed using more than one word. The idea should have at least a noun and a verb, when appropriate—for example, “forms are not submitted in a timely manner” or “staff does not use consistent hand-washing technique.” Arrange the cards or notes so that everyone can see them. Some teams place them on a large table; some affix them to the wall. 2. Sort the ideas into groups of related topics. The sorting is done by the whole team, guided only by gut instinct and working in silence most of the time, except to agree on general clusters for groupings. If an idea is repeatedly moved back and forth from one group to another, agree to create a duplicate card or note and place one in each grouping.

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Overlapping ideas can be combined. It is appropriate for some ideas to stand alone. A cluster can contain any number of cards. Often 7 to 10 clusters or groups will emerge. Reach a consensus on how cards are sorted. 3. Create header or title cards for each grouping. The team should discuss each grouping and create a title or header for it. The team may want to break large groupings into subgroups with subtitles. However, the team should be wary of over-refinement at this point if it slows progress. Titles must be concise and make sense even when separated from the individual ideas in their group. 4. Draw the diagram, connecting all header cards within their groupings. The diagram usually looks something like a simple organizational chart. Review the diagram with the team and individuals not on the team who may be involved with the issues. It may be helpful to post the diagram in a public place, providing adhesive notes so other staff can add their ideas.


Table 3-1. Considering Failure Modes and Generic Effects Possible Failure Modes

Possible Generic Effects

Wrong drug

No injury

Wrong dosage

No injury but increased length of stay to monitor effects

Wrong frequency

Injury with no permanent loss of function

Wrong route of administration

Injury with permanent loss of function; death

Affinity diagrams can help reassure team members that a seemingly amorphous problem really does have a recognizable shape. Chapter 5 provides more information on affinity diagrams; an example can be found in Figure 5-1, page 85.

Both effects can be problematic. Consider Table 3-1, above. Any one of the possible failure modes listed on the left side of the table could lead to any one of the possible generic effects listed on the right side of the table.

Identifying Potential Effects of Failure Modes

Failures that occur in process steps nearest to the individual receiving care are more likely to result in injury or harm than failures that occur earlier in the process. Likewise, errors that occur earlier in the process are more likely to result in process disruptions such as delays or additional work. However, in the absence of sufficient quality control mechanisms, even failures that occur early in the process can reach the care recipient. 5

The second activity of this FMEA is to identify the potential effects of the identified failure modes. This should occur when all team members are satisfied that all potential failure modes have been described.5 Effects, the “E” in FMEA, are the results of failure modes. In other words, what could happen if a failure mode actually occurs? Effects of failure modes might be direct or indirect, long term or short term, likely or unlikely to occur. In any case, they are the result of the impact of a particular failure mode on the stability of the entire process or a portion thereof. A failure effect is the consequence(s) a failure mode has on the operation, function, or status of a process step. The severity of effects can vary considerably. Each failure mode may have one or multiple effects. For example, if the FMEA team has identified “selecting the wrong medication” as a potential failure mode in its medication management FMEA, the following two possible effects could be identified7: 1. The individual is given the wrong dose of medication. 2. A delay in treatment could occur because time is taken to secure the right medication.

FMEA teams should consider the specific effects of a failure mode. For example, perhaps the wrong drug is given to the wrong individual because the prescriber’s handwriting was not legible and was misinterpreted; the effects on the individual receiving the incorrect drug could range anywhere from a minor allergic reaction, such as hives, to anaphylactic shock resulting in death. Or illegible handwriting could result in the wrong drug dosage; the effects might range from receiving a lethal dose of chemotherapy to experiencing no injury but suffering a bit more pain after receiving only one half the prescribed dosage of aspirin. Use of the brainstorming process will help the FMEA team identify as many potential effects as possible. The key question to rise with each failure mode is “If this failure occurs, what might the consequences be to the care recipient?” The team should take time with this step to ensure the identification of

53


Table 3-2. Workarounds and Potential Failures Workaround

1. User scans medication from patient drawer without visual check of medication list, medication name, and dose.

2. Physicians do not review eMAR to verify current medications

3. User administers medication without reviewing parameters for medication administration.

4. Users bypass policy for “medication double check” by second provider, or second nurse confirms without reviewing medications.

Possible Errors

Description or Example

Data Sources

Wrong medication, dose, route

Staff are required to check the medication label and compare this visually with the electronic medication administration record (eMAR) before scanning. They might, however, rely on the alarms from scanning as the sole confirmation of correctness

• Observation • FMEA

Inappropriate monitoring of medication; wrong medication, dose, route

Physicians may not be trained on, or have log-ins for, the barcode medication administration system (BCMA), and therefore eMAR access is difficult. Or eMAR data are not presented in a manner usable for physicians. Therefore, eMAR is not routinely reviewed and physicians are not aware if medications are administered, held or omitted, and do not stop unneeded medications.

• Interview • FMEA • Meeting participation

Wrong medication, dose, route, time

BCMA system cannot show all administration information for a particular medication on one screen; therefore, an icon appears to click to see additional information. However, the icon fails to reflect it if information is present or when information has been updated, and is thus missed.

• Observation • FMEA


Hospitals often require a second nurse to confirm medication name, dose, and patient for high-risk medications. BCMA may be set up to require the documentation of this confirmation. Documentation may be bypassed by overriding the medication in the BCMA system or by a pro forma confirmation by another nurse.

• Observation • Interviews • FMEA • Meeting participation

(continued)

54


Table 3-2. Workarounds and Potential Failures, Workaround

5. User does not check/verify patient’s new medication orders before administering medication.

6. User administers medication without scanning patient ID to confirm correct patient.

7. User administers medication without scanning medication barcode to confirm it is correct medication, time, dose.

continued

Possible Errors

Description or Example

Data Sources


When a new medication order is processed, the BCMA system is updated after pharmacist entry and the order is available for nurse verification, but is not final until verified. Staff might not verify order for change in the medication (dose change, discontinue, etc.) before administering the next medication dose in the eMAR.

• FMEA

Wrong patient

Nurse scans medications but does not scan patient before administering. ID wristband may be missing, damaged (by body fluids or patient), or inaccessible because patient is sleeping (and RN wishes not to disturb patient).

• Observation • FMEA • Meeting participation • BCMA logs

Wrong medication, dose, route, time

Medication barcode is present but not scanned, so BCMA cannot verify medication and dose. Medication barcode may be damaged or torn, soaked, or crinkled. Scanner may not be available.

• Observation • FMEA • Meeting participation • BCMA logs

Source: Koppel R., et al.: Workarounds to barcode medication administration systems: Their occurrences, causes, and threats to patient safety. J Am Med Inform Assoc 15:408–423, Jul.–Aug. 2008. Used with permission.

all potential effects. It can be helpful to identify all the potential effects for one failure mode before moving on to another. Asking non-team members to help identify the consequences of failure modes can also be very productive. Table 3-2, pages 54-55, shows a portion of a team’s list of failure modes created to identify the ways in which staff was working around the computerized medication system. At this point in the FMEA process, the team should resist any inclination to concentrate on any one failure mode because of the perceived seriousness of its potential effect. The next step in the process will provide a methodical way to prioritize fail-

ure modes based on their seriousness or criticality. Chapter 4 provides more information about this process.

Using an FMEA Worksheet The team’s use of a worksheet that tracks the progress of an FMEA is highly recommended at this point. A worksheet documents process steps, failure modes and effects, and subsequent steps to rate their criticality, determine their possible causes, and identify and implement redesign recommendations. It provides an easy reference or summary of the team’s progress to date and helps the team stay on track with the next FMEA steps. Teams can create their own worksheet or adapt

55


Table 3-3. Example FMEA Worksheet Process Step

Item

12b

Organ donor form in chart

17

23

23

39a

56

Issue

Action

Accuracy of data entry

Identify key elements and frequency of quality audits and devise a plan for random audits of charts as well as how the plan will be implemented

Donor/ recipient form(s)

Concern about confusion when coordinators are working on multiple donors, assigning organs to multiple recipients

• Develop a CHECKLIST and ORGAN MAP to be used by abdominal transplant coordinators. Previously, a similar method was used that allowed the coordinators to track which recipient was assigned each organ. • The program manager will bring these documents to the larger coordinator group for input and validation. • Ongoing evaluation of the design and utility of these tools. Report after one year of use.

Kidney/pancreas preselection of recipients before match run completed—clarify what data is available for transplant coordinators

Time gap between when transplant coordinator is asked by transplant surgeon to identify a potential recipient and when the match run is ready for review

• Tissue typing department has reported the matchrun list is available for coordinators to use approximately two hours in advance of the full crossmatch list. • Manager to educate on-call transplant coordinators about the availability of the list to facilitate recipient selection.

Use of computer queries in transplant database may make preselection of organ recipients more reliable

• Currently, a “hot list” is pulled for liver and pancreas recipients, which makes it easier for coordinators to address surgeon’s questions (previous surgeries, body mass index, etc.). • Preselecting kidney recipients is more difficult because the list is much longer. A database query tool can help coordinators start selecting recipients. Program manager will design an in-service training session for on-call coordinators to learn about using this tool.

Known, ongoing issue

Plan-Do-Study-Act in progress with organ procurement organization and University of Wisconsin laboratory, with two changes being tested: (1) at hospitals in donor service area—improved guidance (verbal and written) given to staff about elements of obtaining and labeling specimens; (2) information technology programming change to require double-verification of key identifiers by staff from organ procurement organization.

Kidney/pancreas preselection of recipients before match run completed—create decision support tools

Specimen labeling— organ procurement organization


Table 3-3. Example FMEA Worksheet, Process Step

36

Item

Operating room check of three signatures on organ verification form

continued

Issue

Action

Known, ongoing issue

• Per group discussion, to be handled on a case-bycase basis. Operating room s taff should promptly report these occurrences to the administrative program director. • Consider use of Patient Safety Net to report these. Relates to surgeons’ requirement to lead a preoperative time-out.

Source: Steinberger D.M., Douglas S.V., Kirschbaum M.S.: Use of a Failure Mode and Effects Analysis for Proactive Identification of Communication and Handoff Failures from Organ Procurement to Transplantation. Prog Transplant 19:208–214, Sep. 2009. Used with permission.

one used by other organizations. Whether or not the team creates its own worksheet or adapts one, the team might want to consider the following points: ■ Consider and identify possible FMEA worksheet column headers. These could include the following: ✓Steps in a process or links between steps ✓Potential failure modes ✓Potential effects ✓Probability of occurrence of failure modes ✓Detectability of failure modes ✓Probability of occurrence of effects ✓Severity of effects ✓Risk priority number or criticality index ✓Root causes of failure modes ✓Redesign recommendations ✓Person(s) responsible for the actions ✓Target completion date for test ✓New process implementation date and actions ✓Monitoring mechanism and frequency ■ Determine the worksheet’s scope by selecting column headers. ■ Fill in the worksheet as the team progresses. Make sure to use concise wording. Lengthy sentences will decrease the usefulness of the worksheet as an at-a-glance look at team progress. ■ Use boldface type to highlight key information such as risk priority numbers, criticality indexes, and completion dates.

Table 3-3, pages 56-57, provides an example of an FMEA worksheet with action items included. Now that the failure modes have been identified, Chapter 4 will teach your team to prioritize those failure modes to help focus your process improvement efforts on those likely to cause the most harm.

57


Case Study

Conducting FMEA on Medication Requests at Amerikan Hastanesi

Step 3: Diagramming the Process and Brainstorming Potential Failure Modes Following is the flowchart of the medication preparation and distribution process at Amerikan Hastanesi.

(continued)

58


Case Study

Conducting FMEA on Medication Requests at Amerikan Hastanesi, continued

The failure modes were then identified along with the likely effects of those failures.

(continued)

59


Case Study

Conducting Failure Mode and Effects Analysis on Medication Requests at Amerikan Hastanesi, continued

References 1. Crow K.: Failure mode and effects analysis (FMEA), 2002. http://www.npd-solutions.com/fmea.html (accessed Mar. 4, 2010). 2. Stamatis D.H.: Six Sigma and Beyond: Design for Six Sigma, Vol VI. CRC Press LLC: Boca Raton, FL, 2003. 3. Tischler L.: Seven secrets to good brainstorming. http://www.fastcompany.com/articles/2001/03/kelley.html (accessed Mar. 4, 2010). 4. Reason J.: Error: Models and management. BMJ 320(7237):768–770, Mar. 2000. 5. Spath P.: Home study program: Using failure mode and effects analysis to improve patient safety. AORN J 78:15–44, Jul. 2003.

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Chapter 4

Prioritizing Failure Modes T

he goal of the prioritization effort is to identify those failure modes most in need of further analysis to improve processes and reduce the risk of harm. In other words, prioritization helps identify those risks that most exceed acceptable limits.1 Once a team prioritizes failure modes, it is in a better position to identify which ones are most important to analyze further and address through redesign. FMEA teams can take a variety of approaches to this step. In this book, the step is broken down into two parts: 1. Determine the criticality of each failure mode 2. Prioritize the failure modes

While this may seem like a subtle distinction, one cannot prioritize a list of items without first specifically determining how important or critical each item is.

Determining Criticality Criticality is a relative measure of the importance of a failure mode based on its consequences, its frequency of occurrence, and other factors.2 How critical or important a failure mode is depends on the combined influences of several factors. Severity, probability, detectability, cost, and timing all play a part in determining the amount of attention a failure mode requires. When determining criticality or importance, teams should consider the following criteria related to the failure mode and its potential effects: Failure Mode Criteria ■ Probability of occurrence of the failure mode (often referred to as “frequency” or “likelihood” of occurrence) ■ Detectability Effects Criteria ■ Probability of occurrence of the effect (If the failure mode occurs, how likely is it to result in the bad effect?) ■ Severity (How serious is the bad effect when it occurs?) Other Criteria ■ Cost ■ Timing ■ Availability of resources









61


Teams should note that “probability of occurrence” appears in two instances. The first case of its use answers the question “How probable is this failure mode?” The second case of its use answers the question “Given the occurrence of a particular failure mode, how probable is this particular effect?”

Determining Severity In this context, severity relates to the seriousness of the injury or impact that could ultimately result if an effect of a failure mode occurs. In rating severity, team members should look at the effect of the failure mode, not at the failure mode itself. How do failure mode and effects analysis (FMEA) teams judge how severe a consequence of an effect might be? The process is

a subjective one that involves use of judgment, intuition, and, at times, imagination. If the effect has been experienced before within the health care setting or other similar settings, the team may be familiar with its severity, and the rating may not be difficult to determine. If the effect has not occurred within the organization, professional judgment and imagination may be required to determine a severity rating. Table 4-1, below, provides an example severity scoring scale.

Determining Probability of Occurrence The probability of occurrence is the likelihood that something will happen. The key question the team asks at this point is “What is the likelihood that this failure mode or effect will occur?” The team might want to frame the answer to that

Table 4-1. Example Severity Scoring Scale Rating

Description

Definition

1

Minor effect or no effect

Would not be noticeable to individual served and would not affect the process

2 May affect the individual served and would result in some effect on the process

3

4

5

Moderate effect

May affect the individual served and would result in a major effect on the process

6

Minor injury

Would affect the individual and result in a major effect on the process

Major injury

Would result in a major injury for the individual served and have a major effect on the process

Catastrophic effect; a terminal injury or death

Extremely dangerous; failure would result in death of the individual served and have a major effect on the process

7

8

9

10

62

Chapter 4: Prioritizing Failure Modes

Case Study Conducting FMEA on the Opioid Prescribing Process at University of Texas M.D. Anderson Cancer Center

Step 4: Prioritize failure modes.

.

When prioritizing failure modes, Virginia Gonzalez, accreditation coordinator, says it helped to focus on failures that the group would be able to address through process redesign. “For example, we don’t have computerized physician order entry,” says Gonzalez. “That’s a $5 million expenditure and another major project. It’s not something that this group can address at this time, so we can’t just say, ‘Well, computerized physician order entry would solve this.’ Ginger and I worked to direct the discussion to process breakdowns we could target.” Also, Allen Burton, M.D., notes that the facilitators were important in keeping the failure mode conversations on track. “As caregivers, we tend to want to solve the problem right away—this is especially true of physicians. We want to start coming up with solutions but Ginger and Virginia made sure that we completed this step before moving on to identify process redesigns.” Ideas that could not be addressed in this FMEA project were documented for consideration at a later time.

question in terms of mathematical ratios. For example, there is a low probability, or 1 in 100,000 chances that something could occur versus a high probability, or 1 in 10 chance that it could occur. An instance of a remote failure is a vial of a medication from a pharmaceutical manufacturer containing a different drug than the label says it does. A more probable failure mode is that a prescription arrives in the pharmacy with illegible handwriting. Note that FMEA teams determine the probability of occurrence of both failure modes and effects. When a failure mode or effect has occurred in the past, data may be readily available to assist the team in determining probability of occurrence. When data are not available, teams have to use their professional judgment in estimating probability of occurrence. In determining probability of occurrence, teams will want to consider the interrelationship of possible failure mode and possible effects. Latent conditions can coincide with active failures to allow an adverse effect to occur. Teams need to consider the interrelationship and interdependence of both active failure modes and latent conditions, their probability of occurrence, and the probability of creating specific effects. Latent condi-

tions cannot be summarily dismissed because of low probability of occurrence. Their interaction with other failure modes must be considered. Table 4-2, page 64, is an example probability of occurrence scale. Tables 4-3 and 4-4, page 65 and 66, provide examples of individual organizations’ analysis of severity and probability of occurrence.

Determining Detectability As a next step, the team can determine a detectability rating for each failure mode. Detectability is the degree to which something can be discovered or noticed. The key question that the FMEA team asks is “If this failure mode occurs, how likely is it to be detected?” A high rating indicates that the failure would not be noticed, thereby placing the individual receiving care at risk of experiencing the effect of the failure because no corrective action to protect the individual is likely to occur. A low rating indicates that the failure is certain to be noticed or is highly likely to be noticed, thereby decreasing the likely risk to the care recipient. How tightly processes are coupled is inversely related to the detectability of failure modes. As mentioned in Chapter 2 on page 26–27, failures occurring in tight-

63


Table 4-2. Possibility of Occurrence Scale

Rating

Description

Probability

Definition

1

Remote to nonexistent

1 in 10,000

No or little-known occurrence; highly unlikely that condition will ever occur

Low likelihood

1 in 5,000

Possible, but no known data; the condition occurs in isolated cases, but chances are low

Moderate likelihood

1 in 200

Documented, but infrequently; the condition has a reasonable chance to occur

High likelihood

1 in 100

Documented and frequent; the condition occurs very regularly and/or during a reasonable amount of time

Certain to occur

1 in 20

Documented, almost certain; the condition will inevitably occur during long periods typical for the step or link

2

3

4

5

6

7

8

9

10

ly coupled processes, whose steps follow one another in rapid sequence, are less likely to be detected than failures occurring in loosely coupled processes, which provide an opportunity to detect failures and permit intervention to correct the problems and protect from harm. If a failure is detected, controls, barriers, or other mechanisms can be used to prevent the effect of the failure from occurring, reaching the individual, or harming that individual. Effective barriers provide an opportunity to intervene in some way—through

64

human intervention, through an automated response, or through system design, such as fail-safe systems to protect the individual receiving care. For example, some computerized medication ordering systems use a fail-safe design that prevents physicians from entering a lethal dose of a drug. This barrier can help prevent overdoses. Chapter 6 provides more information about failsafe designs. To determine the detectability of a failure mode, an FMEA team asks, “What are the current controls or barriers to this failure


Table 4-3. Example of a FMEA from an Interventional Pulmonology Program Hazard ID and Description

001 Lack of oxygen in bottles attached to anesthesia machines.

002 Inserting an angiocatheter into the cricothyroid membrane without a swivel may result in harm or death.

003 “Safety” catheters cannot be connected to syringe with fluid in it for insertion into the cricothyroid membrane to “aspirate air bubbles” and validate correct position in the trachea. Syringes are not always present in the jet vent bags. Provide 10-cc syringes in the bags.

Status

Open

Monitor

Monitor

Severity

I*

I

I

Probability

Recommendation

D*

Procedures require that prior to the medical procedure, do the following: open tank, record pounds of pressure available, close tank, and bleed tank lines. Is it still necessary to teach this with automated machine checkout?

D

1. Ensure that swivels are reliably connected to jet vents. 2. Ensure that no safety catheters are stocked in jet vent bags. 3. Change label on jet vent bag to state “One 14 G and one 16 G nonsafety IV catheter.” 4. Provide all OR jet vent bags with checklist label for contents.

D

Replace the “safety” catheter with 14 G and 16 G non-safety angiocatheters.

* I = Category I, the highest level of severity (death, permanent total disability, system loss exceeding $1 million, or severe environmental damage); D = Remote probability (unlikely but can reasonably be expected to occur). Source: Herzer K.R., et al.: A practical framework for patient care teams to prospectively identify and mitigate clinical hazards. Jt Comm J Qual Patient Saf 35:72–81, Feb. 2009. Used with permission.

mode?” and “What is the opportunity to intervene if the barrier detects the failure?” Table 4-5, page 69, provides an example detectability scale.

Choosing a Rating Scale Health care leaders and staff should choose the scale they believe will be most effective; however, that scale should be used consistently. For example, a 10-point scale or a 5-point scale can be chosen. Juran’s classic quantitative model uses a 10-point scoring system to rate the severity of the potential effect, frequency of occurrence, and detectability of the failure. 3 No matter what type of scale a team chooses, team members should reach an agreement on what each point on the scale

means. For example, if the team is planning to use a 10-point scale, the team should discuss and agree on the definitions of each point on the scale, such as how the rating of 1 or 10 is defined. Concise definitions of each point on the scale speeds the process of rating failure modes and their effects. Reminding team members of the meaning of the different numbers on the scale is important. Some teams put up posters in the FMEA team meeting room that outline the scoring criteria.

Choosing the Rating Method A simple approach may involve team members assigning a qualitative (for example, high, medium, low) rating to each failure mode. The following section discusses some other methods organizations can use for rating the importance of failure modes.

65


Table 4-4. Screening for Diabetes (Potential Hypoglycemic Reaction): Potential Causes of Failure, Hazard Analysis, and Decision Tree Analysis Hazard Analysis

Decision Tree Analysis

Potential Case

Severity Score

Prob. Score

Hazard Score

Single-Point Weakness

Detect cta able?

Proceed?

Acti tio on

Patient not asked if he or she had diabetes at time of scheduling

1

4

4

No

No

No

Add question to procedure scheduling form

Patient response not recorded

1

4

4

Yes

Yes

Yes

Educate assistant to document screening response

Patient not asked if he or she had diabetes at time of telephone confirmation

2

4

8

No

No

No

Develop checklist for phone calls

Yes

Add question to consent form, instructions for patients with diabetes, and request form

Yes

Add question to consent form, instructions for patients with diabetes, and request form

Yes

Add question to scheduling form, preprocedure screening checklist, and request form

Yes

Add question to scheduling form, preprocedure screening checklist, and request form

Diabetes status not confirmed on day of 3 the procedure

Diabetes status not confirmed at time of 3 consent

If patient had diabetes, he or she was not instructed to eat prior to procedure If patient had diabetes, he or she was not instructed to take insulin as needed

3

3

1

1

4

4

3

3

12

12

No

Yes

No

No

No

No

No

No

Source: Herzer K.R., et al.: A practical framework for patient care teams to prospectively identify and mitigate clinical hazards. Jt Comm J Qual Patient Saf 35:72–81, Feb. 2009. Used with permission.

66


Case Study Conducting FMEA on the Psychosocial Assessment Completion Process at Health Care for the Homeless (HCH) Step 4: Prioritize failure modes.

When the HCH team discussed the priority of the failure modes, Kennedy and Geraty often deferred to the therapists when there was disagreement. “They have a better understanding of the real-life barriers to getting those assessments done,” says Kennedy. In some instances, the team looked for a compromise to come up with a number that everyone could agree on. The team then used an online tool to help calculate the risk priorities. Step

Failure Mode

Causes

Effects

Occ.

Det.

Sev.

RPN

1. Client sees therapist case manager (TCM) for first time

Client leaves before being seen by the TCM

Long wait times, clients’ low frustration tolerance, psychotic symptoms, difficulty with navigating check-in and registration

Client would need to return to clinic as a walk-in and complete process

5

3

5

75

2. Initia Initiall mental mental health health assessment completed

TCM does not complete initial mental health assessment

Client leaves during session

Treatment interrupted

2

1

3

6

3. Schedule follow-up appointment to begin psychosocial assessment

TCM does not schedule followup appointment

Schedule booked up, TCM forgets, client refuses

Interrupts or delays treatment process

1

1

5

5

4. Client comes in for second appointment

Client does not come in for second appointment

Transportation, mental health symptoms, finances, client goes to another source for treatment

Treatment interrupted and assessment is not begun

6

1

9

54

5. TCM copies demographic data from encounter sheet to psychosocial intake assessment sheet

TCM does not copy demographic data from encounter sheet to psychosocial sheet

TCM interrupted and forgets

Form incomplete and chart data inaccurate

1

1

2

2

TCM does not gather data

Client did not show up, TCM does not have time to complete, other tasks take priority

Assessment does not get completed

8

5

9

360

6. Interviews client to gather data to complete IPSE

(continued)

67


Case Study Conducting FMEA on the Psychosocial Assessment Completion Process at Health Care for the Homeless (HCH), continued Step

Failure Mode

Causes

Effects

Occ.

Det.

Sev.

RPN

TCM does not educate client on the process

Client crisis, TCM schedule overbooked, client mental illness can interfere, lack of self-efficacy on the part of the client

Client will not receive benefits and resources

3

2

2

12

8. If internal referral is given, appointment is put into database

Internal referral not given or appointment not put into system

Referral source not available, client might refuse, TCM forgets Client would not to give referral, comreceive needed puter problems, TCM services forgets to put into system

2

8

1

16

9. If external referral is given, written information is given to client

Written information not given to client

TCM forgets, client crisis, not enough time

Client less likely to connect to referral source

3

8

4

96

10. TCM makes follow-up appointment

TCM does not make follow-up appointment

TCM overwhelmed by client crisis, TCM forgets, client refuses, client referred out

Client may disconnect from treatment, psychosocial not completed

2

2

10

40

11. TCM provides mental health diagnosis and completes assessment

Diagnosis not made, assessment not completed

Assessment not completed, client not TCM forgets, client properly assessed, crises take priority, takes longer to comclient’s illness plete assessment, impedes ability to proassessment not usevide information ful as a treatment tool

8

2

10

160

12. TCM signs assessment

TCM does not sign assessment

TCM is distracted and Assessment not forgets, assessment completed, out of not completed compliance

2

7

8

112

13. TCM files assessment in assessment section of chart

Assessment not filed or misfiled in chart

Chart unavailable at time of assessment, TCM distracted

4

2

9

72

7. If client needs benefits/insurance, TCM educates client on the process

Assessment missing and possibly assumed not completed

Occ: Likelihood of occurrence (1-10); Det: Likelihood of detection (1-10) 1 = Very likely it will be detected, 10 = Very likely it will not be detected; Sev: Severity (1-10); RPN: Risk Priority Number

68


Table 4-5. Example Detectability Scale Rating

Description

Probability of Detection

Definition

1

Certain to detect

10 out of 10

Almost always detected immediately

High likelihood

7 out of 10

Likely to be detected

Moderate likelihood

5 out of 10

Moderate likelihood of detection

Low likelihood

2 out of 10

Unlikely to be detected

Almost certain not to detect

0 out of 10

Detection not possible at any point

2 3 4 5 6 7 8 9

10

Focusing on Severity and Probability

A simple approach to rating is to focus on two factors—the severity (of the effect) and the probability (of the effect). Multiplying the severity of the effect by the probability of the effect (based on historical data or estimates of frequency, irrespective of the possible cause) yields a number that indicates the most critical effects (that is, those with the highest point value). The team can analyze the failure modes that were identified as potentially causing these effects, as well as other factors, such as detectability, preventability, and controllability. Risk Priority Number

Another commonly used method to calculate criticality is to calculate a risk priority number (RPN), also called a criticality index, based on severity, occurrence, and detection ratings. The mathematical calculation is as follows: RPN = Severity Rating x Probability of occurrence rating x Detectability Rating Or, simplified, RPN = Severity x Occurrence x Detectability A team can choose to calculate an RPN for a failure mode as a whole. Failure modes with high RPNs automatically warrant

attention. A team can also choose to calculate an RPN for each effect and then add the RPNs for each effect together to get an overall criticality value for the failure mode. This is the most rigorous approach to quantifying risk because it considers each possible effect of each failure mode. This level of detail is presented here to demonstrate the factors that might be considered. Table 4-6, page 70, illustrates the process. Failure Mode 1 has two potential effects whose RPNs are 126 and 196. Adding these, Failure Mode 1 has a criticality value of 322. Failure mode 3, which has the most severe potential effect (one with a rating of 10) and one other possible effect, has a criticality value of 195. The criticality values are used to establish a priority ranking for further analysis of failure modes.

Reaching Consensus No matter what rating method and rating scale the team uses, team members must reach consensus on the ratings assigned. This may be challenging because of the different perspectives of individual team members. Robin E. McDermott and colleagues recommend the following strategies for reaching consensus4: ■ Agree as a team on how disagreements will be handled. Structure the process for resolving disagreements. 69


Table 4-6. Determining Risk and Criticality for Priority Ranking Most critical failure mode Failure mode

Effect

Sev

Prob

Det

RPN

FM #1

Effect 1a

3

6

7

126

Effect 1b

7

4

7

196

Effect 2a

3

3

2

18

Effect 2b

7

3

2

42

Effect 3a

10

5

3

150

Effect 3b

3

5

3

45

FM #2

FM #3

Crit

Rank

322

1

60

2

195

2

Most severe effect

When there is disagreement on ratings, the individuals representing each viewpoint should present their rationales for a specified and finite period of time. Team members can then cast their votes for the rating they would prefer. The leader then calculates the mean rating to determine a score that represents the average rating. The team discusses the rating. ■ If one or more team members still do not agree on the rating, the team might want to invite a process expert who is not currently on the team to join the conversation and provide additional information. This person should not provide the ranking determination, but rather offer additional information that the team might not otherwise have. ■ Consider the failure modes or effects relative to each other by placing the modes or effects in order from the highest severity to the lowest severity. Then indicate the ratings for each. ■ Avoid assigning a rating arbitrarily because this could result in a decision not to focus on the failure mode. When the ratings are multiplied, a small point difference can have a significant impact on the RPN. Talk out sticky issues until they are resolved. ■ If resolution or consensus still cannot be reached, the team might agree to bias the decision toward the safe side by assigning the higher rating.

■

Once the FMEA team determines quantitative and/or qualitative values for each failure mode, based on such factors as severity, probability of occurrence, and detectability, the team

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should transfer these numbers to the FMEA worksheet. At this time, the team might choose to consider other factors associated with the failure mode, such as the cost of fixing it, timing, related performance or quality improvement initiatives, and availability of resources.

Prioritizing Failure Modes At this point, the team is ready to prioritize the failure modes. Failure modes must be ranked to establish priorities for actions. With limitless resources, teams could pursue root cause analysis (RCA) and improvement or redesign of each and every failure mode. In reality, few organizations have the resources to do this. Because RCA takes time, it makes sense to prioritize the failure modes to make the most efficient use of the time spent by the team on proactive risk reduction. The team must concentrate on those failure modes most likely to result in adverse occurrences, thereby negatively affecting the safety of individuals served. These failure modes are ranked high on the list of items requiring action because they involve the greatest degree of risk. Several tools can help the team prioritize failure modes. The team should feel free to use whatever tool is most helpful to achieving the objective, which is to identify those failure modes that are most in need of attention. For example, Pareto charts illustrate the relative ranking of failure modes in a visual way. In other cases, simple numeric order rankings can provide all the help that is needed.


Case Study Conducting FMEA on Medication Requests at Amerikan Hastanesi Step 4: Prioritize failure modes.

The Amerikan Hastanesi FMEA team conducted a risk analysis, coming up with a risk priority score based on the severity and probability of occurrence of the effect. The failure modes were listed in order of risk priority score, highest to lowest; because some steps repeat in this list (since they have multiple failure modes that received different risk scores) the order number in the first column served as a reminder of the order of the steps in the overall process.

Order Process/SubRank process/Activities

Potential Failure Modes

Failure Effects

Risk Analysis— Initial Status Sev.

Occ.

4

Porter leaves order at the Pharmacy

An emergency order is left for later

There might be a delay in treatment

9

9

5

Orders are controlled and prepared by Pharmacy staff

The wrong medication is sent (dosage, route, name, formula)

Wrong medication might be administered

9

9

5


Drug-drug interaction control is not made

Side effects might occur

10

8

1

Order is sent to chemotherapy nurse

Mistake in the repeat order


9

8

1



Medication might be administered in the wrong dose

9

8

2

Nurse pulls out the original and first copy of the order from the file and the medication is put into the request bag

Mistake in an urgent-emergency request

Treatment might be delayed

7

10

5


Drug-food interaction controls are not followed and orange warning label is not attached

Side effects might occur

8

8

5


Medications are not labeled

Patient might be administered wrong medication

8

8

5


Medication label is not attached to medication bag


8

8

(continued)

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Case Study Conducting FMEA on Medication Requests at Amerikan Hastanesi, continued

Order Rank

72

Process/Subprocess/Activities

Potential Failure Modes

Failure Effects

Risk Analysis— Initial Status Sev.

Occ.

5




8

8

5



Wrong dose might be administered

8

8

10

Medication cabinets are locked

Cabinet cannot be locked

Safety of the medication is an issue

8

8

5


“Adjust the dosage” label is not attached

Wrong dose might be administered

8

8

4



Delay during patient discharge

7

9

4


Discharged patient baskets are mixed up

Delay during patient discharge

7

9

3

Pharmacist controls and prepares orders

Label is forgotten (high-risk medication)

Medication goes out without a label

7

9

2

The dosage amounts requested are written out

Mistake is made in calculations in adjusting dosage

Medication might be administered in the wrong dose

9

7

2


Colored pencil has not been used

Less medication than was requested might be sent or no medication is sent

7

8

5



Might be administered to wrong patient

7

8


Case Study Conducting FMEA on the Neonatal Intensive Care Unit Laboratory Test Ordering Process at Miami Valley Hospital

Step 4: Prioritize failure modes.

The FMEA team began prioritizing the failure modes, considering the relative rates of occurrence, severity, and detectability, and the level of control that staff had over that failure. In addition, those failures that resulted in additional sticks were given higher priority. This is the stage many FMEA teams will assign risk priority numbers, however, the team discovered that some failure modes had more than one potential root cause; therefore, risk priority numbers were assigned at Step 5, after root causes were identified. The failure modes and risk priority numbers can be found in Chapter 5, on page 90.

al way. In other cases, simple numeric order rankings can provide all the help that is needed. Teams that have quantified the risks involved with particular failure modes using RPNs may choose a cutoff point to help with prioritization. Failure modes with scores below the cutoff point do not need to be pursued unless time is available. Failure modes with scores above the cutoff point must be explored. While this arbitrary cutoff point is helpful in paring down the number of priorities, one risk of using this approach is that important projects that don’t make the cutoff are ignored and other projects that are less important make the cutoff because of the way the RPNs were calculated. For example, if a team established a cutoff point of 50, meaning that failure modes with RPNs of less than 50 would not be the sub ject of further focus, a failure mode with an RPN of 40 would be dropped from focus. Yet any failure mode with a high severity ranking poses a possible threat to safety. These types of failure modes must be addressed, regardless of their occurrence or detectability ranking. Similarly, a failure mode with a high occurrence rate could end up with a high RPN, even if it has a very high detectability ranking.

The safest rule of thumb when using RPNs is to focus on eliminating failure modes associated with severity rankings of 8 or above and those with high RPNs. Keep in mind that RPN values are meaningful only in a comparative sense. They can be compared only within one FMEA, not across multiple FMEAs. References 1. Spath P: Home study program: Using failure mode and effects analysis to improve patient safety. AORN J 78:15-44, Jul. 2003. 2. Dodson B., Nolan D.: The Complete Guide to the CRE. Houston: Quality Publishing, 1996. http://www.qualityamerica.com/ knowledgecente/articles/fmea1.html (accessed Mar. 4, 2010). 3. Gryna (1988) as cited in Juran J.M., Juran G., Blanton A. (eds): Juran’s Quality Handbook, 5th ed. New York: McGraw-Hill, 1999, pgs. 19–26. 4. McDermott R.E., Mikulak R.J., Beauregard M.R.: The Basics of FMEA, 2nd Edition. New York: Productivity Press, 2009.

At this point, judgment comes into play, and the team should take a second look at things below the cutoff point to make sure that important processes are not overlooked. Doing so combines a quantitative and qualitative approach to priority ranking, which is very appropriate, given the nature of health care.

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Chapter 5

Identifying Root Causes of Failure Modes B

efore failure mode and effects analysis (FMEA) teams can identify improvement actions to eliminate or reduce potential failures, they must identify and understand the root causes of the prioritized potential failure modes. Root causes are the most fundamental reasons a problem could occur. Most root causes in and of themselves are not sufficient to cause a failure; rather, the combination of root causes sets the stage for potential failure.

Root cause analysis (RCA) is a process for identifying the basic causal factors that underlie variation in performance. RCA is often used after sentinel events occur, to learn how the error(s) happened. However, in the context of FMEA, RCA is used to analyze what could go wrong with health care processes and systems. An RCA focuses primarily on systems and processes, not on an individual’s performance.




Using Root Cause Analysis An RCA approach can be used prospectively to probe a failure mode or a combination of modes that could occur in the future. Through the study and proper design or redesign of processes, future problems can be prevented, or, when the problems cannot be prevented, the individual can be protected from the effects of the problems, or the effects of the problems can be mitigated. Although a failure mode is the result of a potential unexpected variation in a process, variation is inherent in every process. To reduce the variation, it is necessary to determine its cause. In fact, variation can be classified by cause. Common-cause variation, although inherent in every process, is a consequence of the way a process is designed to work. For example, a team is 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 on when the report is requested. On a particular day, there may be many concurrent requests for reports, making it difficult for the radiology department to fill one specific request. Or the report may have been requested between midnight and 6 A .M. 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 work load. A






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process that varies only because of common causes is said to be stable. Common-cause variation is systemic and endogenous—that is, produced from within. Common-cause failures occur as a result of the way a process itself is designed. Therefore, such failures can be prevented through redesign of the process. Another type of variation, special-cause variation, arises from unusual circumstances or events that may be difficult to anticipate and may result in marked variation and an unstable, intermittent, and unpredictable process. Special-cause variation is not inherently present in systems. It is exogenous—that is, produced from without—and results from factors that are not part of the system as designed. Mechanical malfunction, intoxicated employees, floods, earthquakes, and hurricanes are examples of special causes that result in variation or failures. Special causes should be identified and mitigated or eliminated, if possible. However, removing a special cause will eliminate only that current abnormal performance in the process. It will not prevent the same special cause from recurring. Special causes in one process are usually the result of common causes in a larger system of which the process is a part. For example, mechanical breakdown of a piece of equipment may indicate a problem with an organization’s preventive maintenance activities. Similarly, an intoxicated employee indicates a problem with the organization’s screening and hiring practices. Human resources practices need to be examined for commoncause problems involving personnel screening and interview processes. What implications does this have for the FMEA under way within an organization? Because failure modes represent variation, FMEA teams should ask the question “Is this failure mode the result of a common-cause variation or a special-cause variation?” Failure modes created by a common-cause variation can be addressed (that is, eliminated or their likelihood reduced) by redesigning the process. Failure modes created by a special-cause variation require further analysis through prospective RCA to identify the process or system factors that, when redesigned, will reduce or eliminate this type of failure.

Identify All Root Causes The identification of all root causes is essential to preventing a potential failure. Why? The interaction of the root causes is likely to be at the root of what led to the problem. If an organization eliminates one root cause only, it reduces the likelihood of that one very specific cause from occurring. But if the organization misses the other five root causes, it is possible that those root causes could interact in a different way to cause a different but equally adverse outcome. The root causes collectively repre-

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Tip: Effective Root Cause Analyses (RCA) There are several characteristics of an effective RCA, including the following: • Focuses primarily on systems and processes, not on individual performance • Progresses from special causes in clinical processes to common causes in organization processes • Repeatedly digs deeper by asking “why?”; then, when answered, asks “why?” again, and so on • Identifies changes that could be made in systems and processes—either through redesign or development of new systems or processes—that would reduce the likelihood of failure modes occurring • Is thorough and credible

sent, in effect, latent conditions waiting to happen. The combination of root causes sets the stage for failure modes. Effective identification of all the root causes and an understanding of their interaction can aid an organization in changing processes to eliminate a whole family of risks or failure modes—not only a single risk or mode.

Conducting the Root Cause Analysis FMEA teams conduct RCAs to determine why a failure mode identified by the team as a high-priority one for future attention could occur. The analysis involves asking a series of “why” questions that probe deeper and deeper to uncover root causes and their relationships. The basic structure of the questioning process is as follows: ■ What could happen? (the failure mode) ■ Why could this happen? That is, what are the most proximate causes? These typically involve special-cause variations. ■ Why could these proximate causes happen? That is, what systems and processes underlie those proximate causes? Common-cause variation here may lead to special-cause variation in dependent processes. Teams will note that these are the same questions asked in a retrospective RCA of a sentinel event, except that “did” is substituted for “could” with retrospective analysis. Proximate causes are acts or omissions that naturally and directly could produce a consequence. They are the superficial, most

Chapter 5: Identifying Root Causes of Failure Modes

Case Study Conducting FMEA on the Psychosocial Assessment Completion Process at Health Care for the Homeless

Step 5: Identify root causes of failure modes. To identify the root causes of the failure modes, the FMEA team consulted with other therapist case managers to make sure that all of the causes were thoroughly explored. After discussing the failure modes with the group, it became clear that the root causes for many of the barriers to assessment completion were related to overscheduling, forgetfulness of the therapist, difficulties in getting compliance from the client, or a combination thereof.

apparent, or immediate possible reasons for an occurrence. When looking at the chain of possible causation, proximate or direct causes tend to be nearest to the origin of the possible failure mode. They generally can be gleaned by asking “Why could the failure happen?” By contrast, possible root causes are systemic and appear far from the origin of the potential failure, often at the foundation of the processes involved in the event. For example, possible root causes of a potential medication error might include communication problems, staff training, look-alike drug labels, ineffective pharmacy recall processes, and so on. Drilling even deeper, a team might determine that possible root causes of a potential medication error include inefficient information technology systems or inadequate resource allocation for staff education. In most cases, identifying the possible proximate causes will be simple; in other cases, it might take some brainstorming. For example, in exploring possible causes of potential adverse occurrences related to falls, proximate causes could include “failure to monitor individual,” “bed alarm not working,” “call light not working,” “individual is not properly oriented to use of call light,” “incorrect sedation dispensed,” or “incorrect administration of sedation.” Characteristics of proximate causes include the following: ■ Readily apparent ■ Appear to be most immediate reasons for a possible occurrence ■ Lay closest to the origin of the possible failure mode ■ Typically involve a special-cause variation ■ Often involve human error or equipment malfunction

In the health care environment, proximate causes tend to fall into a number of distinct categories beyond, and in addition to, process factors. These include human factors, equipment factors, controllable or uncontrollable environmental factors, and other factors. To identify the proximate cause of a failure mode involving human factors, the team might ask, “What human factors are potentially relevant to the failure mode?” To identify the proximate cause of a failure involving equipment factors, the team might ask, “How does the equipment performance potentially affect the failure mode?” To identify the proximate cause of a failure mode involving environmental factors, the team might ask, “What environmental factors potentially directly affect the failure mode?” and “Are such factors within or truly beyond the organization’s control?” Finally,

Tip: Example Proximate Causes— Preventing Suicide In identifying the proximate causes for a suicide, a team might conclude that proximate causes could include the following: • Human factors involving failure to follow policies on precaution orders or failure to conduct appropriate staff education/training • Assessment process factors involving a faulty initial assessment process that does not include identifying a past history of suicide attempts or an immediate psychiatric consultation • Equipment factors involving a nonfunctional paging system that delays communication with the individual’s physician

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Tip: Possible Questions to Uncover Causes To help uncover the reasons behind a particular failure mode, a team might want to start with the following questions: • What safeguards are missing in the process? • If the process already contains safeguards (for example, double checks), why might they not work to prevent the failure every time? • What would have to go wrong for a failure like this to happen? • If this failure occurred, why would the problem not be identified before it affected an individual?

the team might ask, “Are there any other factors that could directly influence this failure mode?”

Probing for Root Causes The FMEA team is now ready to identify the root causes of a possible failure mode. This represents a deeper level of digging to determine the systemic roots of a potential problem. At this point, the team has a detailed list of proximate causes that describe the care processes and other factors that might contribute to a failure. The team again asks “why?”: “Why could this proximate cause happen? What systems and processes could underlie proximate and other contributing factors?” The goal of asking questions at this stage is to identify possible underlying causes for the proximate causes. More questions the team can ask in the effort to uncover causes include the following: ■ What safeguards are missing in the process? ■ If the process already contains safeguards (for example, double checks), why might they not work to prevent the failure every time? ■ What would have to go wrong for a failure like this to happen? ■ If this failure occurred, why would the problem not be identified before it affected the individual receiving care? ■ Is this failure more likely to occur at a specific location or time? ■ Are particular personnel more likely to experience this failure? As in all other stages of the process, it is critical for the team to focus on probing for system or common-cause problems, rather than on human errors. Teams can sometimes have trou-

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ble at this stage because of the tendency to stop short after identifying proximate causes and not probe any deeper. The probing must continue until a reason underlying a cause can no longer be identified. Again, in most cases, a special cause of variation in one process is often found to be the result of, or permitted by, a common cause of variation in a larger system of which the process is a part. Identifying a special cause is only an initial step in a full evaluation.

Looking at Functions or Processes Listing and categorizing the possible causal factors represents one way to determine what systems are involved with a potential failure mode. Root causes of a failure mode in health care can be categorized according to the important organization functions or processes that the organization performs. These can include processes for the following: ■ Leadership—embracing a culture of safety, supporting performance and quality improvement, and clear communication of priorities ■ Human resources ■ Information management ■ Environmental and equipment management In addition, factors beyond an organization’s control should be considered as a separate category. Teams need to exercise caution in assigning factors to this category, however. Although a causative factor may be beyond an organization’s control, the protection of care recipients from the effects of the “uncontrollable factor” is within the organization’s control in most cases and should be addressed as a risk-reduction strategy. Concrete questions about each function mentioned here can help teams reach the essence of the problem—the systems that lie behind or underneath problematic processes. At this stage, questions can be worded in the form “To what degree is … ?” Follow-up questions for each could be “Can this be improved and, if so, how?” and “What are the pros and cons of expending the necessary resources to improve this?” See Sidebar 5-1, page 79, for a list of possible questions. While this list represents a start to the process, other questions may emerge in the course of an analysis. All questions should be fully considered. Sidebar 5-2, page 81, provides a handy checklist to ensure that the team has considered selected system-based issues. The team’s list of possible causal factors may be lengthy. Regardless of its length or the technique used, the team should consider analyzing each possible cause or factor one at a time. Asking the following two questions will help to clarify whether


Sidebar 5-1.

Possible Root Cause Analysis Questions

The following questions may be used to probe for system problems that underlie problematic processes. Questions concerning leadership issues may include the following: • To what degree is the culture conducive to risk identification and reduction? Can this be improved and, if so, how? What are the pros and cons of expending the necessary resources to improve this? • To what degree can leadership manage change and provide resources for performance improvement? • To what degree is the communication of information among participants adequate? Can this be improved and, if so, how? What are the pros and cons of expending the necessary resources to improve this? Questions concerning human resources issues may include the following: • To what degree are staff members properly qualified and currently competent for their responsibilities? Can this be improved and, if so, how? What are the pros and cons of expending the necessary resources to improve this? • How does actual staffing compare with ideal levels? Can this be improved and, if so, how? What are the pros and cons of expending the necessary resources to improve this? • What are the plans for dealing with contingencies that would tend to reduce effective staffing levels? Can this be improved and, if so, how? What are the pros and cons of expending the necessary resources to improve this? • To what degree is staff performance in the operant processes addressed? Can this be improved and, if so, how? What are the pros and cons of expending the necessary resources to improve this? • How can orientation and in-service training be improved? What are the pros and cons of expending the necessary resources to improve this? Questions concerning information management issues may include the following: • To what degree is all necessary information available when needed? What are the barriers to information availability and access? To what degree is the information accurate and complete? To what degree is the information unambiguous? Can these factors be improved and, if so, how? What are the pros and cons of expending the necessary resources to improve in this area? Questions concerning environmental and equipment management issues may include the following: • To what degree is the physical environment and equipment appropriate for the processes being carried out? Can this be improved and, if so, how? What are the pros and cons of expending the necessary resources to improve this? • To what degree are systems in place to identify environmental risks? Can this be improved and, if so, how? What are the pros and cons of expending the necessary resources to improve this? • What emergency and failure-mode responses have been planned and tested? Can this be improved and, if so, how? What are the pros and cons of expending the necessary resources to improve this?

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each cause listed is actually a potential true root cause: 1.If we fix this cause, could the failure mode occur in the future? 2.If this cause is a root cause, does it help explain the possible failure mode? (Note that if the failure mode were the result of a combination of root causes, no one root cause alone would fully explain the failure mode.) If the answers are “yes,” then the problem is a root cause. It is highly likely that the team will identify more than one root cause for a possible failure mode. It is important to ask how the possible root causes are related. Would the potential failure mode occur if each possible cause were not present? If the team identifies more than six root causes, a number of the causes may be defined too specifically. In this case, the team might want to review whether one or more of the root causes could logically be combined with another to reflect more basic, system-oriented causes. The team should verify each of the remaining potential root causes. This involves cross-checking for accuracy and consistency all facts and all tools and techniques used to analyze information. Any inconsistencies and discrepancies should be resolved. How does a team know whether and when it has identified all the potential root causes of a possible failure mode? Teams should resist the temptation to stop drilling down too soon. However, if potential root causes fully explain from all points of view why the failure mode would occur, and the potential root causes are logical, make sense, and dispel all confusion, then it is likely that the team has analyzed that possible failure mode fully and correctly.

Resources for Root Cause Analysis There are several different resources that provide the level of detail and thoroughness teams need to uncover the root causes of failure modes. The process knowledge and experience brought to the table by current FMEA team members provides one place to start. The team can turn to individuals who have process expertise but who are not currently on the team to gain additional insight. Other organizational staff and the care recipient and their families can provide valuable input into the RCA process. Interviews and surveys can be used to obtain information from such individuals (see Sidebar 5-3, page 82). Review of the organization’s policies and procedures related to the process under study can also provide valuable information for the RCA process, as can review of professional standards of

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Tip: Possible Characteristics of Root Causes • Root causes are systemic. • Root causes appear far from the origin of the failure. • The origins of root causes lie in common-cause variation of organization systems

care that are available organizationwide and in the professional literature. Another way to gain information about a process is to look at performance measurement data related to that process. Measurement data can provide a baseline when little objective evidence exists about a process. For example, a health care organization may want to learn more about the current level of staff competence. A dementia long term care or psychiatric special care unit might want to know more about the effectiveness of the bed alarm systems to prevent falls and elopement. Specific indicators for a particular outcome or a particular step in a process may be used for ongoing data collection. Once assessed, these data can help the FMEA team determine whether a process is ineffective and needs more intensive analysis. Data about costs, including costs of faulty or ineffective processes, may also be of significant interest to leaders and can be part of ongoing performance measurement. For more on effective data collection, see Sidebar 5-4, page 82. Data from performance measurement activities can also be used to gain more information about a process chosen for assessment and improvement. For example, perhaps a performance rate varies significantly from the previous year, from shift to shift, or from the statistical average. A team may be measuring staff compliance with the organization’s restraint

Tip: Definition of Measure An indicator, or measure, is all of the following: • Quantitative. It is expressed in units of measurement. • Valid. It identifies events that merit review. • Reliable. It accurately and completely identifies occurrences. • A measure of a process or outcome. It involves a goal-directed series of activities or the results of performance.


Sidebar 5-2.

Checklist: Problematic Systems or Processes

Use this 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 could be considered a contributing factor. Leadership and Communication Issues • Culture conducive to risk reduction • Corrective actions identified and implemented • Risk-reduction initiatives receive priority attention • Barriers to communication of risks and errors • Communication ❏ Present, as appropriate ❏ Appropriate method ❏ Understood ❏ Timely ❏ Adequate • Managerial controls and policies ❏ Appropriate controls and policies in place ❏ Policies enforced ❏ Communication regarding policy changes Human Resources Issues • Qualifications of staff ❏ Defined ❏ Verified ❏ Reviewed and updated on regular basis • Qualifications of physicians ❏ Defined ❏ Verified ❏ Reviewed and updated on regular basis • Qualifications of agency staff ❏ Defined ❏ Verified ❏ Reviewed and updated on regular basis • Training of staff ❏ Adequacy of training program content ❏ Receipt of necessary training ❏ Competence/proficiency testing following training • Training of physicians ❏ Adequacy of training program content ❏ Receipt of necessary training ❏ Competence/proficiency testing following training • Training of agency staff ❏ Adequacy of training program content ❏ Receipt of necessary training ❏ Competence/proficiency testing following training • Competence of staff ❏ Initially verified ❏ Reviewed and verified on regular basis

• Competence of physicians ❏ Initially verified ❏ Reviewed and verified on regular basis • Competence of agency staff ❏ Initially verified ❏ Reviewed and verified on regular basis • Supervision of staff ❏ Adequate for new employees ❏ Adequate for high-risk activities • Current staffing levels ❏ Based on reasonable individual acuity measure ❏ Based on reasonable work loads • Current scheduling practices ❏ Overtime expectations ❏ Time for work activities ❏ 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 Environmental Management Issues • Physical environment ❏ Appropriateness to processes being carried out ❏ Lighting ❏ Temperature control ❏ Noise control ❏ Size/design of space ❏ Exposure to infection risks ❏ Cleanliness • Systems to identify environmental risks • Quality control activities ❏ Adequacy of procedures and techniques ❏ Inspections • Planned, tested, and implemented emergency and failure mode responses

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Sidebar 5-3.

Tips for Successful Interviews

• Open the interview by stating the focus and purpose of the interview. Reiterate that information obtained will be used to help improve processes in order to enhance safety. • Pose open-ended questions, which elicit more than just a “yes” or “no” response. Start with an exploratory question, such as “What can you tell me about X?” and follow up by asking a question such as “Why?” or “What do you mean by Y?” or “Can you tell me more about X?” • Listen well and avoid interrupting the interviewee. • Ask questions with a purpose. Avoid being talkative. • Summarize throughout the interview to ensure a proper understanding of what the interviewee related. • Be aware of body language and other nonverbal cues. • Before closing the interview, ask if the interviewee has any questions or concerns, summarize the whole interview, and thank the interviewee, expressing appreciation for the individual’s time, honesty, and assistance.

policy, for instance. Records may indicate that the staff on duty during weekend hours did not properly document the monitoring of individuals in restraint or obtain appropriate orders for restraint use. Or, perhaps the data indicate that restraints are used with an increased frequency when specific personnel are present. Perhaps monitoring problems or inappropriate restraint use is suspected as a part of a root cause of a failure mode. Such findings may reveal problematic trends and help an FMEA team identify possible causal factors for failure. Successful measurement requires indicators that are stable, consistent, understandable, easy to use, and reliable. Indicators, or performance measures, are devices or tools for quantifying the level of performance that actually occurs. They are valid if they identify events that merit review, and they are reliable if they accurately and completely identify occurrences.

Tools to Help with Root Cause Analysis A team can use a variety of tools to help ensure a thorough RCA. Some of these same tools can be used to help implement and measure the effectiveness of proposed actions. A matrix list

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Sidebar 5-4.

Criteria for Data Collection

Choosing what to measure is critical. So is ensuring that the data collected are appropriate to the desired measurement. This checklist includes criteria to help the team ensure that the data collected are appropriate for monitoring performance. ❏

The measure can identify the events 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 data intended for collection are available. ❏ Results can be reported in a way that is useful to the organization and other interested customers.

of tools can be found in Table 5-1 on page 84. The following is a discussion of some of these tools and their applicability to the FMEA process.

Brainstorming Brainstorming can help identify all potential contributing causes to a potential failure. Following the traditional brainstorming ground rules (see Chapter 3), such as “There is no bad idea,” is necessary in order to generate well-thought-out and probable causes to issues. Affinity Diagram An affinity diagram can be used to help identify proximate causes, root causes, and improvement opportunities. As mentioned in Chapter 3, this tool allows teams to organize a large volume of ideas into meaningful groups. Once the team has brainstormed and recorded ideas about a process, the team facilitator can randomly display index cards or adhesive notes with the ideas so that everyone can see them. Team members then sort the ideas into groups of related topics and create header or title cards for each grouping. Ideas



Step 5: Identify root causes of failure modes. For this step, the three teams were brought back together. The facilitators noted that there were barriers to getting all members of teams to meet at once; therefore, each team had a representative assigned to ensure that the information discussed in the all-team meetings was communicated to each respective team. Despite the complexity of the process, many of the failure modes had the same root causes, including the following: • Omission errors secondary to automatic stop order • Suboptimal patient involvement in medication histories • Suboptimal medication reconciliation by clinicians • Confusing epidural and patient-controlled analgesia order sets • Lack of electronic medication administration record • Lack of computerized order entry

should be sorted in silence, with team members guided by their gut instinct. If an idea keeps getting moved back and forth from one group to another, the team should agree to create a duplicate card or note. The team may need to allow for some ideas to stand alone. It may be helpful to break large groupings into subgroups with subtitles, but be careful not to slow progress with too much definition. Once the team reaches consensus on the groupings and headers, connect all header cards with their groupings then draw the affinity diagram. An example of an affinity diagram can be seen in Figure 5-1, page 85.

Cause-and-Effect Diagrams Cause-and-effect, or fishbone, diagrams can help present a clear picture of the many causal relationships between outcomes and the contributing factors to those outcomes. They can also highlight which process steps and linkages could be involved in a failure. To create a cause-and-effect diagram, a team should determine general categories for possible causes of a failure mode. It should represent common categories, including work methods, personnel, materials, and equipment, on the diagram by connecting them with diagonal lines branching off from the main horizontal line. The team should then list proximate causes under each general category and list underlying causes related to each proximate cause. Figures 5-2 and 53, pages 86-87 offer examples of this tool.

It is important to gather data to determine the relative frequencies of the causes. The team should look for causes that appear continually in the evaluation process. It should place the outcomes on the right side of the page, halfway down, and then, from the left, draw an arrow horizontally across the page, pointing to the outcome. Everyone should agree on the problem statement or outcome, which should be succinct.

Change Analysis This tool can be used to help identify proximate causes and root causes by examining effects of change. This involves identifying all perceived changes and all the possible factors related to the changes. To conduct a change analysis on a particular process, the team must first describe the process as it should occur, in as much detail as possible. Include the who, what, when, where, and how information of the process. Then describe how the process actually occurs and compare the two, trying to detect any differences. List all the differences and analyze them. Carefully assess the differences and identify possible underlying causes. Describe how these affect the process. Did each difference or change explain the result? Integrate information and specify root cause(s). Identify the cause that, if eliminated, would have led to a perfectly conducted process. Remember that not all changes create problems; rather, change can be viewed as a force that can either positively or negatively affect the way a system, a process, or an individual functions.

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Table 5-1. Checklist: Problematic Systems or Processes

Tools

Proximate

Root

Identifying Improvements

Affinity diagram Barrier analysis Box plot Brainstorming Cause-and-effect diagram Change analysis Checksheets Contingency diagram Control charts Cost-of-quality analysis Critical-to-quality analysis Decision matrix Deployment flowchart Effective-achievable matrix Failure mode and eff ects analysis Fault-tree analysis Fishbone diagram Flowchar t Force field analysis Gantt chart Graphs Histogram Ishikawa diagram Is–Is not matrix Kolmogor ov-Smirnov test List reduction Matrix diagram Multivoting Nominal group technique Normal probability plot Operational definitions Pareto chart PDSA (plan-do-study-act) cycle PMI (plus, minus, interesting) Relations diagram Run chart Scatter diagram (scattergram) Storyboar d Stratification Time line Top-down flowchart Why-why diagr am Work-flow diagram

x x

x

x

Implementing and Monitor ing Impr ovements

x x

x x x

x x x x

x x

x x

x x x

x x x x x x x x x x x x

x x

x x x x x x x x x x x x x x x

x x x x x x x x x

x

x x x x x

x x x x x x x

x

x x x

x x

x x x x

x x x x

x x

x

x x x

x

x

x

x

x x

This matrix lists many of the tools and techniques available during root cause analysis and indicates the stages during which they may be particularly helpful. Not all of the tools are profiled in this chapter.

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Figure 5-1 Example Affinity Diagram

This affinity diagram shows how a wide range of ideas can be arranged in manageable order. Using this type of diagram presents ideas about why laboratory results are not available as needed into three categories: routine, results, and ordering.

Figure 5-4, page 88, shows an example change analysis worksheet. Control Charts

A control chart can illustrate whether a variation in a process is statistically in control. It can help identify root causes and opportunities for improvement. It can also help implement and monitor improvements. Control charts are created by calculating an average of specific data related to a process, such as the number of residents who experience a fall per month. The team then calculates the standard deviation—the measure of

the variability of a data set. The team then sets upper and lower control limits. Control limits should be three times higher or lower than the standard deviation, relative to the mean. In creating the control chart, plot the mean (that is, center line) and the upper and lower control limits. Plot the data points for each point in time and connect them with a line. In plotting data points, keep the data in the same sequence in which they were collected. In a control chart, special-cause variation appears as points outside the control limits. In contrast, common-cause variation appears as points between the control limits. Be aware that special causes of vari85


Figure 5-2 Example Cause and Effect Diagram: Contributory Factors to Suicide

This figure illustrates how the generic diagram can be adapted to specific needs. This detailed diagram breaks down the contributory 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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Figure 5-3 Example Cause and Effect Diagram: Improving Diabetes Screening

People Potential Failures: - Patient not asked if they have diabetes at time of scheduling Potential Causes: - No reminder or question in procedure scheduling form Potential Solutions: - Develop specific question in the procedure scheduling form

Policy Potential Failures: - Patient diabetic status not confirmed at time of consent Potential Causes: - No policy regarding diabetic patient care before interventional procedure Potential Solutions: - Make staff aware of policy - Add question to consent form, diabetic instructions, and request form - Document diabetic status Improved screening for diabetes before interventional procedures

Supply Potential Failures: - No blood glucose monitoring device available

Equipment Potential Failures: - Code cart and monitoring equipment not available

Potential Causes: - No standard location identified for supplies

Potential Causes: - No standard location identified for code cart and monitoring equipment

Potential Solutions: - Develop daily checklist of intervention room supplies - Document daily checklist - Identify standard location for supplies

Potential Solutions: - Identify standard location for code cart and monitoring equipment - Daily check of code cart and monitoring equipment

This is a cause-effect-solution diagram for improvement of screening for diabetes before interventional procedures. Source: Abujudeh H.H., Kaewlai R.: Radiology failure mode and effects analysis: What is it? Radiology 252:544–550, Aug. 2009. Used with permission.

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Figure 5-4 Change Analysis Worksheet

Event

Nonevent

Differences

Analysis

What (conditions, activities) When (occurrence) Where (physical location, step in procedure) How (omission, out of sequence, poor procedure) Individual involved (by title- not name)

This generic worksheet shows a simple way of listing and comparing information for change analysis. The worksheet is arranged in columns and lead logically from what happened and what did not happen, to the differences between them, and an analysis.

ation must be eliminated before the process can be fundamentally improved and before the control chart can be used as a monitoring tool. The following four rules for identifying an out-of-control process include: 1. One point on the chart is beyond three standard deviations of the mean. 2. Two of three consecutive data points are on the same side of the mean and are beyond two standard devtions of the mean. 3. Four of five consecutive data points are on the same side of the mean and are beyond one standard deviation of the mean. 4. Seven consecutive data points are on one side of the mean. The terms in control and out of control do not signify whether a process meets the desired level of performance. A process

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may be in control but consistently poor in terms of quality and the reverse may also be true. While control charts can be helpful, charting something accomplishes nothing; it must be followed by investigation and appropriate action. Examples of control chart patterns can be seen in Figure 5-5, page 89.

Fault-Tree or Event-Tree Analysis Fault-tree analysis, or a tree diagram, is a graphical, deductive tool for systematically listing various sequential or parallel events or combinations of faults that must occur for a particular undesired event to occur. A fault-tree diagram resembles a logic diagram or flowchart. 2 Fault-tree analysis, or a tree diagram, can be used to help consider multiple, interacting failures. It can also help identify proximate causes, root causes, and opportunities for improvement. The following six steps are involved in fault-tree analysis: 1. Define the top event of interest.


Figure 5-5 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). Teams should determine whether such a single occurrence is likely to recur.

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Step 5: Identify root causes of failure modes. Some of the failure modes had multiple potential root causes. The FMEA team assigned risk priority numbers at this stage in the process, after the root causes were identified. One method used was chart audits. “We reviewed more than 30 patient charts and found that more than 16% had discrepancies between physician orders and what the health unit coordinators were entering,” explains Suzette Smith, senior management engineer, quality management. Another method used to uncover root causes was by walking through the process. This is how the team learned that some confusion was caused by the way some information appeared on the computer screen, and that some fields in the lab orders were printing differently in the lab than they looked on the screen. When the root causes were identified, the team assigned a risk priority number to each failure root cause pairing. Process Component

Failure Mode

Cause(s) of Failure

Occ.

Det.

Sev.

RPN

1. Physician writes order

1A. Unable to read orders

Physician handwriting illegible

3

1

10

30

1B. Previous order not discontinued

Assumption that other orders are automatically discontinued Example: Assuming that admit labs would discontinue after writing new labs.

9

9

7

567

Physician overlooks previous orders

4

9

7

252

1D. Write order for wrong Mix up with multiple births baby

2

9

10

180

2A. Chart not collected

Chart overlooked in collection

3

8

8

192

2B. Chart not returned

New resident places chart in wrong place

3

8

8

192

3A. Order not entered

Overlooked among multiple line items

9

10

10

900

1C. Duplication of orders

2. Physician returns chart to desk

3. Help unit coordinator (HUC) enters order into computer system

(continued)

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Case Study Conducting FMEA on the Neonatal Intensive Care Unit Laboratory Test Ordering Process at Miami Valley Hospital, continued

Process Component

4. HUC signs paper order and places chart in out rack

Failure Mode

Cause(s) of Failure

Occ.

Det.

Sev.

RPN

3B. Wrong lab entered

Human error

5

8

10

400

Misinterpret order—unclear order for nonroutine lab

5

7

9

315

3C. Enter order for wrong day

Human error

2

8

10

160

3D. Enter order for wrong baby

Mix up with multiple births

1

7

10

70

3E. Order not entered as written by physician

Computer system functionality issue—example: Date/Time mismatch

4

2

8

64

3F. Lab order not customized

Computer system functionality issue—multiple steps and multiple screens make it difficult to customize the orders

5

3

7

105

3G. Orders entered different ways by different HUCs

No standardization of routine HUC procedures for entering orders

10

9

9

810

3H. Multitasking and distractions

NICU environment and work load

10

1

10

100

4A. Paper record not in chart

Paper record placed in wrong chart

2

8

7

112

Order sheet left in fax machine

2

2

5

20

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Case Study Conducting FMEA on Medication Requests at Amerikan Hastanesi, Istanbul, Turkey

Step 5: Identify root causes of failure modes. This team found the root causes of the failures and effects listed and learned that some failures had the same cause. The following table lists the root causes identified. Note: The failure modes were listed in order of risk priority score, highest to lowest. Because some steps repeat in this list (they have multiple failure modes that received different risk scores), the order number in the first column serves as a reminder of the order of the steps in the overall process. Order Rank

Process Step

Prioritized Failure Modes

4

Porter leaves order An emergency order is left for later. at the Pharmacy.

Mix-up of concepts of “Emergency” and “Urgent.” Non-detection of state of emergency.

5


Wrong medication is given (dosage, mode, name, formula)

Confusion in division of labor Heavy telephone traffic Divisions stemming from technicians’ training Carrying out all procedures at the same desk Narcotics not being requested promptly Magistral medications not being requested promptly Illegible order Placing returned medication on wrong shelf Incomplete writing out of order

5

Orders are controlled and prepared by pharmacy staff

Drug-drug interaction check is not made

Leaving implementation for later System is not clearly known

2. Construct the fault tree for the top event. List the major contributory factors under the top event as thefirst-level branches. Generally, the contributory factors can be grouped under such headings as “Personnel,” “Material or Equipment,” “Procedures/Processes,” and so on. 3. Continue the branching process by adding another level to the tree. These are the factors that might have accounted for the first-level branches. 4. Add additional levels of branching, as necessary. 5. Validate the tree diagram. Review the visualized events for accuracy and completeness.

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Main Causes

6. Modify the diagram, as necessary. Retest the modified diagram. An example of a fault-tree analysis diagram can be found in Figure 5-6, page 93.

Histogram A histogram is used to help identify proximate causes, root causes, and opportunities for improvement, as well as for implementing and monitoring improvements. It provides a snapshot of the way data are distributed within a range of val-


Figure 5-6 Example Fault-Tree Analysis Diagram

This diagram shows a fault-tree analysis constructed for administration of radiation with possible errors included as faults. Source: Israelski E.W., Muto W.H.: Human factors risk management as a way to improve medical device safety: A case study of the Therac 25 Source: Radiation Therapy System. Jt Comm J Qual and Patient Safe 30(12):694, Dec. 2004.

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Figure 5-7 Example Histogram

This example histogram was developed to analyze the turnaround time for authenticating verbal orders from physicians. The irregular distribution suggests opportunities for improvement.

ues and the amount of variation within a given process, suggesting where to focus improvement efforts. To create a histogram, teams can take the following eight steps: 1. Obtain the data sets and count the number of data points. Data should be variable (that is, measured on a continuous scale, such as temperature, time, weight, or speed). Make sure data are representative of typical and current conditions. The more data points you have, the more meaningful the patterns. 2. Determine the range for the entire data set. 3. Set the number of classes into which the data will be divided. Be sure that the classes cl asses are mutually exclusive so that each data point will fit into only one class. Using 10 class intervals makes for easier mental calculations. 4. Determine the class width (by dividing the range by the number of classes). 5. Establish class boundaries. 6. To construct the histogram, place the values for the

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classes on the horizontal axis and the frequency on the vertical axis. 7. Count the data points in each class and create the bars. 8. Analyze the findings. Remember that some processes are naturally skewed; do not expect a “normal” pattern every time; however, large variability or skewed distribution may signal that the process requires further attention. An example histogram can can be seen in Figure 5-7, above. above.

Multivoting Multivoting can be used to identify proximate causes, root causes, and opportunities for improvement. It is helpful when the team is trying to narrow down down a broad list of ideas (that is, more than 10) to those that are most important and worthy of immediate attention. This involves reaching team consensus about a list frequently generated by brainstorming. The following eight steps are involved in the multivoting process:


Figure 5-8 Example Multivoting Results

This figure shows the results of multivoting on priorities for improvement at a health center. The team was able to reach consensus on the need for prioritizing the laundering process.

1. Combine any items on a brainstorming or other list that are the same or similar. Ensure that when combining ideas on the lists, the team members who suggested the ideas agree with the new wording. Clearly define each idea so that everyone voting easily understands it. 2. Assign letters to items on the new list. Use letters rather than numbers to identify each statement so that the voting process does not confuse team members. 3. Determine the number of points that will be assigned to the list by each group member. Each member will use a predetermined predetermin ed number of points (typically between 5 and 10) to vote on the different items on the list. 4. Allow time for group members to assign points independently. 5. Indicate each member’s member’s point allocation on the list. 6. Tally the votes. 7. Note the items with the greatest number of points. 8. Choose the final group or multivote again. Figure 5-8, page 96, shows an example of multivoting results.

Pareto Charts Pareto Pare to charts can help visualize causes of a problem by displaying data comparatively. Pareto charts can be used to help identify root causes and opportunities for improvement. They show which events or causes are most frequent and therefore have the greatest effect. This enables a team to determine what problems to solve and in what order. The following eight steps are involved in creating a Pareto chart: 1. Decide on a topic of study. The topic can be any outcome for which a number of potential causes have been identified. If the team is working from a cause-and-effect diagram, the topic will be the effect that has been targeted for improvement. 1 2. Select causes or conditions to be compared . Identify the factors that contribute to the outcome—the more specific, the better. When selecting factors for comparison, beware of grouping several distinct problems together, which can skew the rank order. Refer to the cause-and-effect diagram, and use the most specific causes and factors possible. 3. Set the standard for comparison. In many cases, this will be frequency, although factors may be compared based on their cost or quantity.

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Figure 5-9 Example Pareto Chart

This Pareto chart was used to rank the frequency of responses of selected root causes provided by team members investigating a sentinel event involving a wrong-site surgery.

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Case Study Conducting FMEA to Prevent Pressure Ulcers at Gaylord Hospital Step 5: Identify root causes of failure modes. Although some FMEA teams can get distracted in identifying root causes, the Gaylord team had a strategy that helped to avoid in-team-arguments, says Donna Trigilia, certified wound care nurse and coordinator of the wound care program. Early on, the team members agreed that the following four issues were true in their organization and needed to be corrected as soon as possible for the good of their patients: 1. Wounds were treated inconsistently 2. Skin assessments at admission were inconsistently done 3. Documentation system couldn’t handle what needed to be documented 4. There was no process for showing progress of the wound “These were essentially our root causes,” Trigilia says. “Almost every problem came back to one of these four problems. Reminding ourselves of these periodically also helped keep our team on track and working toward the same goals.” In identifying these causes, the team frequently consulted the literature to learn more about the common causes of failure. The team found that the hospital’s computerized documentation system didn’t allow users to consider skin as an organ with potential for decline (Cause #3, above). Therefore, the patient evaluation processes didn’t include the cues that would remind caregivers to consider skin breakdown.

4. Collect data. Determine how often each factor occurs (or the cost or quantity of each, as appropriate). Use a checklist to help with this task. 5. Make the comparison. Based on the data collected in step 4, compare the factors and rank them from most to least. 6. Draw the chart’s vertical axis. On the left side of the chart, draw a vertical line and mark the standard of measurement in increments. On the right axis, mark the cumulative percentage. 7. List factors along the horizontal axis. Factors should be arranged in descending order, with the highest-ranking factor at the far left. 8. Draw a bar for each factor. The bars represent how often each factor occurs, the cost of each factor, or its quantity, as applicable. Include additional features, if desired. By making a few simple additions to the chart, a team can show the cumulative frequency, cost, or quantity of the categories, in percentages. An example Pareto chart can be found in Figure 5-9, page 96. Run Chart

A run chart can help identify proximate causes and root causes, as well as implement and monitor improvements. It is designed to reflect trends and patterns in a process over a specific period of time so that teams can identify areas that require or are experiencing improvement. The following six steps are involved in creating a run chart: 1. Decide what the chart will measure (that is, what data will be collected over what period of time). 2. Draw the graph’s axes. Clearly mark all units of measurement on the chart. The x-axis should indicate time or sequence; the y-axis should indicate what is being studied. Make sure that the time period for data display is long enough to show a trend. 3. Plot the data points and connect them with a line. Use at least enough data points to ensure detection of meaningful patterns or trends. 4. Plot the center line (that is, the overall average of all measurements). Indicate significant changes or events by drawing dashed lines through the chart at the appropriate points on the x-axis. 5. Evaluate the chart to identify meaningful trends. Do not

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Figure 5-10 Example Run Chart

2009

2010

This run chart is used to display the frequency of restraint use for psychiatric patients.

be too concerned with any one particular point on the chart (that is, wild points); instead, focus on vital changes in the process. Be aware that a run of six or more points on one side of the average indicates an important event or change. 6. Investigate the findings. A run chart example can be seen in Figure 5-10, above.

Scatter Diagram This tool, also called a scattergram, can be used to help identify root causes, as well as implement and monitor improvements. It is designed to display the correlation—not necessarily the causeand-effect relationship—between two variables. The following five steps are involved: 1. Decide which two variables will be tested. Select two variables with a suspected relationship (for example, delays in processing tests and total volume of tests to be processed). 2. Collect and record relevant data. Gather 50 to 100 paired samples of data involving each of the variables and record them on a data sheet. 3. Draw the horizontal and vertical axes. Use the horizontal (x) axis for the variable you suspect is the cause and the vertical (y) axis for the effect. Construct the graph so that val-

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ues increase while moving up and to the right of each axis. 4 Plot the variables on the graph. If a value is repeated, circle that point as many times as necessary. 5. Interpret the completed diagram. The more the clusters form a straight line (which could be diagonal), the stronger the relationship between the two variables. If points cluster in an area running from lower left to upper right, the two variables have a positive correlation. This means that an increase in y may depend on an increase in x; if you can control x, you have a good chance of controlling y. If points cluster from upper left to lower right, the variables have a negative correlation. This means that as x increases y may decrease. If points are scattered all over the diagram, these variables may not have any correlation (the effect, y, may be dependent on a variable other than x). Remember that 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. For an example of a scatter diagram, see Figure 5-11, page 99.


Figure 5-11 Example Scatter Diagram

This run chart is used to display the frequency of restraint use for psychiatric patients.

Criteria for Use and Truncation of RCA Not every failure mode requires a full RCA. Teams may want to cease the RCA questioning process for the following two reasons: 1. At the end of the questioning process, it is clear to the team that nothing can be done to solve the root problems because they are not in the organization’s control. At this point, it is appropriate for the team to shift its attention to the design and implementation of strategies to protect the individual from harm. 2. At some point early in the questioning process, the team is able to identify specific design changes that will prevent the failure mode from occurring. Such “low-hanging fruit” remedies can then be implemented to reduce the risk of harm or protect the individual when the failure does occur.

and ask “Why” again at the next level of the RCA process. While not all failures will need a complete RCA, every failure should be studied, and an RCA should be done when necessary. Team members may find the same or similar root causes for more than one potential failure mode. 1 This should be considered when redesigning the process, as discussed in Chapter 6.

If the team cannot think of a way to prevent a failure mode at one stage of the questioning process, it should probe further

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Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction References 1. Spath P.: Home study program: Using failure mode and effects analysis to improve patient safety. AORN J 78:15–44, Jul. 2003. 2. Spath P.: Worst practices used in conducting FMEA projects. Hosp Peer Rev 29:114–116, Aug. 2004.

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Chapter 6

Redesigning the Process R

edesigning the process is perhaps the most critical step in failure mode and effects analysis (FMEA). The objective is to prevent possible harm.

When the FMEA team has successfully identified root causes of potential failure modes and the interaction of causes that are likely to be problematic, the redesign of the process and its support systems are meant to reduce the risk of occurrence of the potentially problematic failure modes and their interactions that could cause harm to individuals.

Preparing to Redesign Some preliminary work can help teams make the most efficient use of their time during the redesign stage. One strategy that sets the stage for success is focusing the team on addressing the most critical redesign elements to make the redesign process more manageable. To achieve focus, some teams might need to be encouraged by their leaders to “take a deep breath” and concentrate on the task at hand. This requires providing the time and space to do so. Much time can be saved during the redesign process by learning about what other organizations have experienced with the process in the past. Prior to commencing the redesign process, the team can again turn to the professional literature and conduct research to gather process-specific information. As previously mentioned, professional associations and organizations focused on safety can provide a wealth of valuable information. Such information can be used to validate the FMEA process steps conducted thus far and help move the team through the redesign process in a more efficient manner. Colleagues in other organizations can also provide information that is helpful to the redesign process. A team must be committed to not reinventing the wheel. Obtaining information on best practices from a variety of sources is recommended. A team can use such information to expand their vision; they must not let the information limit redesign opportunities.









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Preparing to Redesign • Focus on the most critical elements. • Conduct a literature search to gather relevant information from the professional literature.

The third level of design or redesign focuses on mitigating the effects of errors that reach the individual receiving care. For example, antidotes and resuscitation equipment would be available to mitigate the effects of transfusion failure. These would effectively reduce the severity of the failure’s effects.

• Network with colleagues.

Redesign Strategies Risk-reduction strategies must emphasize systems rather than an individual human approach. If errors are made, if deficiencies are discovered, individuals at each stage must revisit previous decisions and redesign or reorganize the process. There are three levels of designing or redesigning for safety. The first level involves designing or redesigning the process to eliminate or reduce the occurrence, whenever possible, the opportunity for failure. This requires team members to start with the assumption that failures will happen and design or redesign accordingly. The second level of redesign recognizes that even with good preventive design or redesign, failures will occur. Safeguards should be built in to prevent the failure from reaching the care recipient. This means that redesign efforts should focus on increasing the detectability of the failure so that when the failure occurs, someone or something recognizes it, sounds an alarm, and interrupts the process, allowing the failure to be corrected without an adverse result. 1 Design or redesign efforts should protect the person receiving care from possible failures. For example, a computerized medication order entry system may identify an unusual dose (perhaps the result of a misplaced decimal point), provide immediate online feedback to the ordering practitioner, and accept a corrected order, all before the person receives the first dose. This represents a design that includes a means for recognizing an antecedent error, communicating the fact of the error, and modifying (temporarily halting) the process to deal with the error while protecting against an adverse outcome.1

Redesign Strategies • Prevent the failure from happening (decrease likelihood of occurrence). • Prevent the failure from reaching person (increase the probability of detection). • Protect the person if a failure occurs (decrease the severity of the effects; mitigate the effects).

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Each redesign strategy focuses on a different element of the criticality index described in Chapter 4. The first strategy decreases the probability of the failure’s occurrence. The second strategy increases the failure’s detectability. The third strategy decreases the severity of the failure’s effects.

Different Methods for Redesign To redesign processes effectively to prevent harm, FMEA teams need to directly address the characteristics of high-risk processes, as described in Chapter 2. The goal is to reduce an aspect of the process that elevates its risk. Redesign approaches should directly address the following: ■ Decreasing variability ■ Standardizing processes ■ Simplifying processes ■ Optimizing redundancy ■ Using technology to automate ■ Creating fail-safe designs ■ Documentation ■ Reducing coupling ■ Providing comprehensive education ■ Establishing a culture of teamwork

Decreasing Variability Although health care organizations do not have a lot of control over variability of the care recipient, there are strategies that address this risk factor. One strategy involves developing and implementing criteria for the selection of appropriate candidates for elective procedures. Other strategies are to develop and implement pretreatment preparation for high-risk care recipients, manage comorbidities, and match level of care (for example, intensive care units versus regular medical/surgical units) to risk status. Standardizing Processes Standardization can reduce the variability of process implementation and the unneeded variety of factors that can lead to failures. In other words, standardizing a process can make it easier for people to do the right thing and harder for them to make mistakes. Standardizing drug doses and administration times and limiting unneeded variety in drugs, equipment, supplies, rules, and processes of work is a means to reduce errors and potential failures.

Chapter 6: Redesigning the Process

Clinical practice guidelines standardize the care and treatment of individuals with a particular indication or diagnosis. They can improve care and reduce costs and the probability of process failure. For example, protocols for use of hazardous or high-alert drugs can reduce the likelihood of failures at numerous steps and linkages of steps in the medication use process. Protocols for identifying individuals at risk for falls or suicide can reduce the likelihood of failures of steps and links in the assessment process. One standardization activity that organizations should consider is standardizing communication between caregivers—in other words, determining a common language that a health care team can use to communicate about care. For example, in the area of electronic fetal monitoring, there has been a call to standardize language for fetal heart rate interpretation in order to decrease the risk of adverse outcomes. Providing definitions of standardized nomenclature for use in the documentation of electronic fetal heart rate tracing and in interdisciplinary communication regarding such tracings can help everyone be on the same page and prevent errors from occurring because of missed cues.2 One type of activity that can be used to standardize a process is the development of a critical pathway (also referred to as critical path or clinical pathway). The primary objective of a critical pathway is to reduce common-cause variation, thereby reducing the risk of special-cause variation in dependent processes. Critical pathways offer a systematic, flexible guide for standardization of care that can start, for example, before admission and follow the care recipient across all care settings. They are designed by those involved in the process—clients, clinicians, pharmacists, and others—who come together to offer their unique perspectives and expertise. Using a clinical pathway is an excellent way to redesign an existing clinical process that needs change. One advantage of using a critical path is the opportunity to start fresh, cast aside traditional but not particularly effective procedures, and research and implement the best practices. Many critical path ways have been developed to date by numerous organizations, including professional societies, health care organizations, and government—use of predetermined pathways to redesign or to enhance existing clinical processes can also be helpful in standardization. A summary of the steps involved in critical pathways development and implementation appears as Sidebar 6-1, page 104.

Simplifying Processes Simplification reduces process complexity, which is often at the root of process failure. It involves reducing the number of steps and handoffs in work processes as well as standardizing language and tasks. 3 Simplification often involves centralizing activities that are similar but carried out in a variety of locations and settings—for example, implementing a pharmacybased IV admixture program. 4 Simplification should not be confused with taking shortcuts, however. Shortcuts eliminate essential process steps or links. Taking shortcuts, including breaking safety rules such as failing to wash one’s hands between contact or guessing at the meaning of an illegible medication order, is often without immediate consequences, and it relieves the perpetrator of the burden imposed by the rules, thus reinforcing the behavior.5 Optimizing Redundancy Optimizing redundancy means developing backups and backups to backups to reduce the probability of failure. Building redundancy into system redesign can increase system reliability by creating a system that accomplishes what the primary system does should the primary system fail. 5 The cost of such redesigns may be an issue in many instances in the health care environment. However, simple redesign strategies, such as having a second individual check the work of another, are common in health care and can decrease the chance that a failure may reach the individual. For example, two staff members verifying the name on the armband against the name on the label on the blood bag at the bedside before a blood transfusion begins is a built-in redundancy that reduces the likelihood of transfusion errors. Having nursing or pharmacy personnel do a verbal read-back on verbal medication orders requires some additional investment of time but has been shown to reduce interpretation errors. Backups are maximally effective when they are independent of the primary system and not subject to the same external influences.1 For example, having two nurses check the same document to verify the care recipient’s identity may not be as effective as having them each verify identity by using a different primary source. Backup emergency electrical power supply involving an emergency generator that “kicks in” whenever the community-supplied power drops below a critical voltage level provides an example of true redundancy. The secondary backup system is independent of the primary and is automatically activated in response to the detection of a primary system failure. Both are independent of human intervention.

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Sidebar 6-1.

Developing and Implementing a Critical Pathway

Selecting the Process

Identifying or Creating the Critical Pathway

The initial step in creating a critical path is choosing a process to standardize. Consider selecting a process that: • Affects a high number of the care population • Has a high level of variability in treatment and outcomes • Has clear start and end points • Staff expresses a desire to develop

Team members must reach consensus on the key activities involved in each stage of the care process. Members can draw on personal experience and knowledge, existing clinical literature and practice guidelines, and the care recipients’ perspective. When varying styles or methods of care arise—and they inevitably will—the team should not panic. The resulting discussion can yield important knowledge about care.

Defining the Diagnosis, Condition, or Procedure An appropriately defined process and population will simplify critical pathway development. A process that is too broadly defined will result in a path that is either too complex or too vague; conversely, a process that is too narrowly defined can result in a path that applies in only a limited number of cases. Forming a Team

The group that creates the critical pathway must represent all disciplines involved in the process, with a focus on those who perform the “hands-on” tasks of the process. The scope of the process will help determine team members. Another valuable perspective can come from the care recipient and their families or caregivers, customers, and others, such as representatives from social services agencies. The team should elicit information from the people the process is designed to benefit. Similarly, if other parties are involved but are not team members, their input must also be elicited.

Teams should consider that designing in redundancy almost always increases the complexity of processes. With increased complexity comes an increased risk for failure. The failure of a redundant system may not be evident until the backup system is needed.5 Increased complexity and new potential failures should be weighed against possible benefits in each case of process redesign. Backup processes require regular testing to ensure their continued effectiveness.

Using Technology Automation or technology can reduce the likelihood of failures associated with inconsistent or variable input or failures associated with processes or process steps that are heavily depend-

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Subsequent outcome measurement may demonstrate an advantage of one path over the other. The path need not be limited to clinical activities; it can also include activities that surround the clinical process, such as transportation to the radiology department. Critical path ways should also include descriptions of expected outcomes. Despite the complexity of the processes involved, teams should attempt to make their paths as concise as possible—one page is ideal—so they can be used as practical tools in daily practice. At all stages of the care process, staff can refer to critical pathways. The paths should be available to all involved personnel in all the relevant work areas and office locations. Critical pathways are also valuable for the individual receiving care, treatment, or services; they can increase knowledge and sense of partnership with providers. Sources: Panella M., Marchisio S., Di Stanislao F.: Reducing Clinical Variations with Clinical Pathways: Do pathways work? Int J Qual Health Care 15:509–521, 2003; Holloway N. M.: MedicalSurgical Care Planning, 4th Edition. Philadelphia: Lippincott Williams & Wilkins, 2003, pgs. 19–21.

ent on human intervention. For example, computerized order entry systems can reduce medication prescription failures that result from bad handwriting, and they can check the consistency of drug and dosage. Computerized medication order entry systems can increase the likelihood of intercepting failures, including drug–drug interactions, allergies, out-of-range doses, and contraindications. Electronic medical records can help reduce the amount of paperwork required by medical professionals and free up time for care processes. They can also help enhance error prevention by reducing the reliability on human memory. Checklists and screens for risk assessment, pop-up menus for physical assessment, and programmed questions for histories or data collection are just a few of the ways



Step 6: Redesign the process. The team recommended a number of changes to the neonatal intensive care unit lab ordering process. These included the following: • Additional training for health unit coordinators to ensure that they all use the same format when entering lab orders • Additional training for nurses on features of the hospital’s computer system • Reorganization of the computer screens so that all necessary information is visible • Redesign of order slips printed for the lab to ensure that they include all necessary information that appears on the computer screen • Coordination of multiple blood draws for individual patients so they can be done at the same time To address the computer-related problems, the team created an interdisciplinary team made up of members from the neonatal intensive care unit, lab, information technology, and quality management.

that an electronic medical record can help reduce reliance on a medical professional’s ability to remember every step of a process.2

an automated order entry system who dislike dealing with multiple error messages may be able to disable the messaging system effectively. This can actually increase the risk of harm.

Technology and human intervention should be considered complementary rather then competitive. 1 Good performance requires judgment, creativity, the ability to recover from failure, good memory, vigilance, endurance, attentiveness (focus), and patience. Human performance exceeds that of technology in the first three of these activities; technology is better at the rest. Computers and other technologies lack the ability to make allowances for incomplete or incorrect information and can therefore avoid possibly problematic situations. Technology is more consistent and is better at receiving, storing, and analyzing information. Technology does not take shortcuts. It is not influenced by emotion.5 However, human judgment is still superior to a machine when dealing with an unanticipated contingency and adjusting the process to avoid harm. 5

Automated dispensing machines can be misused as well as properly used. For example, routine overrides, available on some automated dispensing units, allow nurses to retrieve medications without a review of the order by the pharmacist. This represents a significant risk point.

The benefits of introducing technological or automated elements in process redesign should be carefully weighed against the risk of removing humans from the picture. For example, bar coding, prescriber order entry systems, and automated dispensing machines can be used to reduce the likelihood of harm to individuals that results from failures in the medication use process. However, integrating new technologies into existing processes requires an understanding of the goals of change. Not all change results in the desired improvement. Physicians using

Creating Fail-Safe Designs A fail-safe design is a design that will tend to revert to a predetermined safe state with respect to if a failure occurs. It is usually safer to refrain from acting—at least for a little while—than to proceed and act incorrectly. Consequently, a process that detects failure and interrupts action is preferable to a process that proceeds in spite of the failure. This often means “pausing” the process to allow for human intervention to assess and deal with the contingency that has caused the interruption. 5 Built-in freeflow protection on an IV infusion pump is an example of failsafe design. One failure mode for older-model infusion pumps occurs when the cassette dislodges from the pump mechanism. When this happens, the entire contents of the IV solution rapidly flow into the individual (for example, 3 liters in 10 minutes). Death due to the inadvertent rapid infusion of toxic drugs can occur. To address this failure mode, pump manufacturers have modified the design to clamp down, or shut off the flow of medica-

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Case Study Conducting FMEA to Prevent Pressure Ulcers at Gaylord Hospital Step 6: Redesign the process. Because the hospital had no formal protocols or procedures for pressure ulcer prevention, this step required designing new processes. The new processes were based on the research the team had uncovered as well as what was learned about the organization throughout the FMEA. Following are some of the features of the new processes: • An interdisciplinary wound care team was formed that included an advanced practice nurse, a unit manager, off-shift supervisors, the director of nursing, an infection prevention and control nurse, a clinical educator, a clinical manager information specialist, dieticians, physical therapists, staff nurses, and occupational therapists. • Key team members obtained certification in wound care. • Practice guidelines were developed based on the guidelines published by the Wound Ostomy Continence Nurses Society, Paralyzed Veterans Association, American Medical Directors Association, Agency for Healthcare Research and Quality, and National Pressure Ulcer Advisory Panel. • Features were added to the computerized records system that allowed caregivers to assess skin condition, develop care plans for skin, and monitor and measure progress of any wounds. • Staff education was conducted to alert staff to the new processes and care guidelines.

tions whenever the cassette is out of the pump mechanism. They have designed the normal position for the line clamp to be closed. When the cassette is inserted into the pump, the clamp opens. In this case, designers have determined that no flow is safer than too much flow, so they have selected “no flow” as the fail-safe mode designed into the system. The design of anesthesia equipment also provides a fail-safe mechanism. Connectors of cylinders for nitrous oxide and oxygen are now different sizes so that they cannot be mistakenly connected. Similarly, oral medications can be placed in syringes or other containers that cannot be connected to needles or IV tubing. Constraints, or “forcing functions,” are aspects of a design that prevents a target action from being performed or allows its performance only if another specific action is performed first. 6 For example, one of the first forcing functions identified in health care was the removal of concentrated potassium from general hospital wards. This action is intended to prevent the inadvertent preparation of intravenous solutions with concentrated potassium, an error that has produced small but consistent numbers of deaths for many years. 6 This reduces reliance on human memory or attentiveness, which can fail if time constraints are too loose or too tight or if vigilance is required for a prolonged period of time.

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Documentation High-quality documentation can reduce the likelihood of failure at various steps or links between steps in a health care process. The objective of any document, like that of any conversation, is communication; the sender and receiver of the information must share an understanding of what is being reported. If time constraints are too tight (or loose), or if steps are tightly coupled, complex, or nonstandardized, documentation can provide the opportunity for caregivers to check the “correctness” of the care recipient’s treatment at a critical point. Sophisticated management information systems and computerized clinical records are increasingly used in various health care organizations. They are helpful tools but are only as reliable as the information on which they are based. FMEA teams should be aware that multiple entries or duplication of documentation increases the failure risk of a process step or link between steps. Certain technology systems may be able to overcome this risk. Computerized prescriber order entry, for example, can eliminate many of the problems associated in the medication use process with multiple entry and duplication of data. Computerized prescriber order entry creates a single source of information about the prescribed medication so that the data need not be reentered numerous times but can be accessed and formatted by different professionals at different locations. For example, the pharmacy staff can use the data for



Step 6: Redesign the process. One of the first changes that the group identified was in the order sets used to prescribe opioids, specifically epidural and patient-controlled analgesia (PCA), which were very crowded with information, and were being interpreted differently by physicians, nurses, and pharmacists. The order sets needed to be redesigned to make it easier to read and complete, as well as to accommodate changes to the prescribing process. Action items were identified to address each root cause, and then noted as being a short- or long-term plan. See the following table. Root Cause

Action Plan

Short or Long Term

Omission errors secondary to automatic stop order (ASO)

Change 7-day ASO to 30-day ASO

Short term

Suboptimal patient involvement in medication histories

Promote use of comprehensive Patient Home Medication List

Short term

Suboptimal medication reconciliation by clinicians

Develop electronic prompt to enhance accuracy of medication reconciliation

Short term

Confusing epidural and patientcontrolled analgesia (PCA) order sets

Revise order sets

Short term

Lack of electronic medication administration record (eMar)

Orient current staff to real-time “Pharmacy” folder in electronic record

Short term and long term

Lack of computerized order entry (CPOE)

Implement CPOE

Long term

the pharmacy medication record; the nursing staff can use the data for the medication administration record. With a single source for the data, the risk of transcription errors is reduced.

Reducing Coupling Another redesign strategy that deserves consideration is reducing the force with which the process steps are coupled, or less tightly coupling the process steps. One goal is to reduce the speed of step sequencing so that when a variation occurs in one step or link, it can be responded to before the next step or link occurs. Perhaps the number of steps can be reduced and the process simplified; perhaps the number of persons involved

and the number of handoffs can be reduced to decrease the risk of failure; perhaps time constraints can be loosened or an alarm system can be introduced to increase detectability of failure when it does occur. Sending e-mail and mailing letters in a postal box are tightly coupled processes. Once the sender has clicked on the send button or dropped the letter in the mailbox, there is no way to undo the command or reclaim the letter. Perhaps an additional step could be added to each process. Another redesign strategy involves tightening time constraints to help decrease failures that result from boredom, inattentiveness, or fatigue. Perhaps the basic design of the process steps needs to be examined and additional steps considered.

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Providing Comprehensive Education Inadequate processes for orientation and training are the second most frequently cited root cause for all types of sentinel events. Education and training provide the foundation of professional competence. Health care professionals are trained extensively prior to assuming care functions. Unfortunately, in our society, after initial training, their performance is expected to be flawless. Training is time limited in its effectiveness and therefore requires ongoing reinforcement, reassessments, and revision to keep pace with evolving health care knowledge. Education and training constitute traditional proactive and reactive initiatives to reduce and prevent errors. Unfortunately, they feed into the notion of perfect performance and the belief that flawed human performance is the root cause of failures. Often, efforts to retrain personnel following the occurrence of errors or sentinel events focus on eliminating human error. Such efforts also are often substitutes for a substantive effort to identify, study, and eradicate systems problems. There are effective educational and training approaches that emphasize systems rather than humans as causative factors for potential or actual failures and the critical preventive role performed by humans. Yet even these approaches are not bulletproof. How can one simulate events that have not yet happened, but could? Or how can one simulate events that have not been foreseen?7 James Reason developed four error management principles that can be applied to training 7: ■ Training should teach and support an active exploratory approach. Trainees should be encouraged to develop their own mental models of the system. ■ Error training should form an integral part of the overall training process. Trainees should have the opportunity to both make errors and recover from them. ■ The heuristics of errors should be changed from “mistakes are undesirable” to “it is good to make mistakes; they help learning.” ■ Error training should be introduced at the appropriate point; midway through a training program. Early in the learning process, trainees are struggling with every step and are unlikely to benefit from error feedback. Later, they are better equipped to learn from such feedback. Many organizations face challenges when trying to introduce new kinds of training programs, such as those centered on team coordination or improving communication. The challenges derive from the fact that training programs require time and

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financial support. If staff members are expected to volunteer unpaid time to attend courses, there is likely to be resistance and resentment; health care organizations should consider providing incentives or paying staff for this training time.

Establishing a Culture of Teamwork While health care organizations are increasingly focusing on teamwork in the care environment, communication problems are still one of the most frequently cited root causes for all types of sentinel events. Teams can be used effectively in improving organization performance and in delivering safe care. Health care organizations must recognize the importance of groups functioning as teams and create interdisciplinary teams or task forces charged with improving organization performance. Studies have found that health care organizations with a teamwork orientation tend to have greater success in their quality improvement efforts. 8,9 Other studies have linked team performance to positive outcomes.10 Teamwork is important not only in complex and dynamic environments such as operating and emergency rooms but throughout care functions and processes. For example, “rounding teams,” including representatives from all disciplines, can direct care at the bedside. One way to test an organization’s teamwork interactions is to conduct a survey among staff. Questions for this survey may include the following 2: ■ Are you comfortable discussing issues with the team? ■ Do you feel you can freely discuss other team members’ deficiencies and unproductive behaviors? ■ Do team members apologize to one another when they say or do inappropriate things? ■ Do team members openly admit mistakes or weaknesses? ■ Do team members take a genuine personal interest in each other? ■ Do team discussions end with clear and specific plans? Do team members understand their responsibilities? ■ Do team members recognize each other’s contributions and thank each other for their input? Organized teamwork can and should provide the impetus for the bulk of organizational performance improvement initiatives. All FMEA teams should consider redesigning problematic processes to encourage a team focus.

Taking a Methodical Approach When designing strategies it is helpful to take a methodical approach. It is also important to remember that existing processes likely have many good features. It should be clearly


Case Study Conducting FMEA on the Psychosocial Assessment Completion Process at Health Care for the Homeless (HCH)

Step 6: Redesign the process. Ideally, the HCH therapist case manager (TCM) meets with the client the first time to decide whether the patient needs to return or be directed to another care provider. If the client needs to return to HCH, the psychosocial assessment typically begins during that second meeting. However, many clients do not return for the second appointment. The FMEA team decided that when scheduling the second appointment, TCMs should write the time and date of the appointment on the back of a business card and mail it to the client. At this time, the TCM should also add a reminder in his or her calendar to complete the assessment by the date of the second appointment. “Process improvement doesn’t have to be a major organizational intervention,” says Kennedy. “Often, fairly simple changes can make a big difference. Also, if the changes are simple, people are more likely to adopt them.”

understood why each process was designed the way it was. The problem may be in the implementation phase of the process, not in its actual design. Shortcuts may be taken that have the effect of bypassing important redundancies. In these cases, teams should examine why shortcuts are taken and address those underlying causes. Sidebars 6-2 and 6-3, pages 112 and 113, respectively, provide some suggestions on how to reduce risks in several high-risk areas.

Considering the Impact of Redesign Elements Once the FMEA team has identified various approaches to improving problematic process steps or links, the team is ready to evaluate the alternatives and select those that are most likely to be successful in preventing failures. The process of evaluating redesign elements begins with the team’s consideration of evaluation criteria, including the following: ■ Chance for success. How likely is the redesign element to succeed in preventing the failure? ■ Staying power. How likely is the redesign element to effect a long-term versus a short-term solution? ■ Reliability. How reliable is the redesign element? Will it work all the time? Part of the time? ■ Risk. How likely is the redesign element to engender other adverse effects within the process or in another health care process? What would happen if this redesign element were not implemented?

Workability. How doable is the redesign element? Does the organization have the resources to make the improvement happen? ■ Barriers to implementation. What are the barriers that this redesign element will likely face during implementation? How receptive will management, staff, physicians, and others be to the redesign element? What will be involved in eliminating barriers to implementation? ■ Compatibility. Is the redesign element compatible with the organization’s objectives and mission? ■ Availability of resources. What will implementation of the redesign element cost? How much staff time will be involved? Is the organization prepared to dedicate all the resources necessary to implement the project? What type of training is involved to bring staff up to speed? Is the organization willing to invest in staff education? ■ Implementation time frame. How long will the redesign and testing take? ■ Measurability and objectivity. How objective is the redesign element? How will improvement be measured? ■

Asking and answering these key questions and those outlined in Sidebar 6-4, page 114, will help the team identify potential barriers to implementation with each redesign element. Teams can rank the redesign elements according to all or selected criteria. Having team members perform their own ranking and then consolidating the ranking into an overall group ranking helps to prevent “group think.” To summarize the potential of each redesign element, the team can ask,

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Case Study Conducting FMEA on Medication Requests at Amerikan Hastanesi Step 6: Redesign the process. After identifying the root causes, the team then began determining how processes could be improved. In addition, they scheduled completion dates for each, and assigned responsible staff. Note: The failure modes were listed in order of risk priority score, highest to lowest. Because some steps repeat in this list (since they have multiple failure modes that received different risk scores) the order number in the first column served as a reminder of the order of the steps in the overall process. Order Process Step Rank

4

5

5

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Porter leaves order at the Pharmacy.




An emergency order is left for later.


Drug-drug interaction check is not made

Main Causes

What Can Be Improved?


1. Clarification of emergency-urgent concepts 2. Informing employees 3. Transition to pneumatic system


1. Setting up a division of labor bulletin board 2. Separating work spaces at the Pharmacy 3. The Pharmacy’s contacting the floors first 4. Sending out reminders or e-mail for timely requests of narcotics 5. Encouraging the accompanying of physicians on patient visits; adding this to the employees’ performance evaluation system 6. Pharmacy orientation program 7. Contacting the physician in the event of an incomplete order 8. Checking and arranging shelves where medication is stored at the pharmacy to improve visual display and make high-risk medications stand out

Leaving implementation for later System is not clearly known

1. Review of control system 2. Defining major drug-drug interactions, adding information about interaction on the physician's order, writing of a pharmacist's note 3. Writing of the pharmacist’s note in red so that it is better seen 4. Sharing of the interaction table over Ahnet.


Case Study Conducting FMEA on Medication Requests at Amerikan Hastanesi, continued

Order Rank

Process Step


Main Causes


Writing of orders without calculating Physician’s using their own prescriptions Not checking medications coming from home

1. Pharmacist’s checking medications coming from home in the Chemotherapy Unit 2. Pharmacist’s checking medications brought in from home by patients on inpatient floors, in accordance with the admissions list sent in daily by Patient Admissions, and writing “Has been controlled” on and signing the “Discharge Plan” form 3. Adding an oncologist to the team

1



1



2


Mistake in an UrgentEmergency Request

The failure of employees to understand the concept

1. Setting up an urgent drawer in every department 2. To set up urgent lists by floors 3. Informing employees 4. Putting Dext.10% in Urgent Drawer (5A-5B)

5


Drug-food interaction controls are not followed and orange warning label is not attached

Not knowing the system

Informing Pharmacy employees

5


Failure to label medications (Expiry date, name)

Interruption in medication information due to termination of medication administered in a single dose

Preparing labels containing the name of the medication and Expiry Date information

5



Heavy workload, writing by hand

Medication labeling risks are eliminated

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Sidebar 6-2.

Reducing Medication Errors: Risk-Reduction Suggestions

To reduce the likelihood of failures associated with prescribing errors: • Implement a system of computerized order entry by physicians (to decrease the likelihood of dosage errors, prompt for allergies, and provide information on drug–drug and drug–food interactions). • Redefine the role of pharmacists to enable them to perform daily rounds with physicians, work with registered nurses, and serve as on-site resources. To reduce the likelihood of failures associated with dispensing: • Do not rely on color-coding. • Remove look-alikes. • Bar code, if possible. • Avoid lethal medications in bolus form. • Use premixed solutions, when possible. • Minimize supplier/product changes. • Use auxiliary labels (“such as, for IM [intramuscular] only”). • Support questioning of unclear orders. • Eliminate guessing. To reduce the likelihood of failures associated with access to medications: • Remove high-risk medications from care units. • Label high-risk medications as such.

• Establish and implement policies and procedures for use of an off-hours pharmacy. To reduce the likelihood of failures associated with medication delivery: • Be sure that equipment defaults to the least harmful mode. • Use automated pharmacy units as a tool for improving the process, not as an inherent solution. • Recognize that polypharmacy equals higher risk. To reduce the likelihood of failures associated with human resources and competence factors: • Address education and training issues (orientation, competence assessment, and training with new medications and devices). • Support professional ethics and judgment. • Implement systems that involve double checks. • Make safe staffing choices. • Tackle illegible handwriting. • Discourage the use of acronyms and abbreviations. • Control the availability of high-risk drugs. • Address environmental issues (for example, tackle distraction and its impact). • Standardize medication times. • Use the care recipient as a safety partner.

Source: The Joint Commission: Sentinel Event Alert http://www.jointcommission.org/Standards/FAQs/ (accessed Mar. 30, 2010).

“What will result from implementing this redesign?” and “What would result from not implementing this action?”

New Processes Present New Problems FMEA teams must be aware that any process redesign changes the inherent risk points. This means that in the new Long-Term Versus Short-Term Plans Depending on the number and scope of actions the team develops, it may be necessary to develop long-term and shortterm plans of implementation. In other words, the team may need to determine what actions can be implemented now ver-

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sus what are going to have to be accomplished in stages or be delayed until resources are available. For example, posting more signage warning of the dangers of smoking around canister gas is a solution that can be implemented right away. Building a new building to house the canister gas is a longterm project that requires board approval, capital outlay, and several steps in order to be accomplished. Not all problems can be solved immediately; leadership should give input on which projects can be tackled now versus which ones should be delayed. A written long-term plan may be helpful so that team members see that management is not ignoring problems, just prioritizing how the problems get fixed.11


Sidebar 6-3.

Risk-Reduction Suggestions for Common Risks

Risk-Reduction Strategies for Restraint Use

• Be cautious at times of change (admission, discharge, passes). • Be suspicious if symptoms lighten suddenly. • Involve all staff in the solutions.

• Do not restrain the individual in the bed with unprotected, split side rails. • Use the appropriate restraint for person, age, and goal. • Never use a towel, bag, or cover over an individual’s face. Risk-Reduction Strategies for Preventing Infant • Ensure that all smoking materials are removed. Abduction • Continuously observe any individual who is • Develop and implement a proactive infant abduction restrained. prevention plan. • Educate staff on appropriate restraint use and alterna- • Include information on visitor/provider identificative measures. tion, as well as identification of potential abductors/ • Revise the staffing model. abduction situations, during staff orientation and in• Ensure staff competence and training. service curriculum programs. • Use less restrictive measures and increase and stan- • Enhance parent education concerning abduction risks dardize choices. and parent responsibility for reducing risk and then • Revise the policy and procedure regarding assessment. assess the parents’ level of understanding. • Attach secure, identically numbered bands to the baby Risk-Reduction Strategies for Reducing Suicide in (wrist and ankle bands), mother, and father, or signifa 24-Hour Care Setting icant other immediately after birth. • Revise assessment/reassessment procedures and assure • Footprint the baby, take a color photograph of the baby, and record the baby’s physical examination adherence. within two hours of birth. • Update the staffing model. • Require staff to wear up-to-date, conspicuous, color • Educate staff on suicide risk factors. photograph identification badges. • Update policies on observation. • Discontinue publication of birth notices in local • Monitor consistency of implementation. newspapers. • Revise information transfer procedures. • Consider options for controlling access to • Revisit contraband policies. nursery/postpartum unit such as swipe-card locks, • Identify and remove nonbreakaway hardware. keypad locks, entry point alarms, or video surveillance • Weight-test all breakaway hardware. (any locking systems must comply with fire codes). • Redesign or retrofit security measures. • Consider implementing an infant security tag or • Educate family and friends on suicide risk factors. abduction alarm system. • Consider the care recipient in all areas. • Ensure that staff members ask about suicidal thoughts every shift. Source: The Joint Commission: Sentinel Event Alert http://www.jointcommission.org/Standards/FAQs/ (accessed Mar. 30, 2010).

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Using Redesign Evaluation and Redesign Tools

Sidebar 6-4.

The Impact of Suggested

Redesign Elements

A number of tools or techniques can be quite helpful to teams in identifying possible redesign approaches or strategies and evaluating and prioritizing these (Chapter 5 gave more details on these tools). Brainstorming can help a team identify ways to redesign a process. Multivoting and selection grids can help a team prioritize possible redesign actions. Cause-and-effect diagrams can help indicate which redesign changes might cause the desired result or goal. Pareto charts can be used to help determine which redesign elements are likely to have the greatest effect in reaching the goal of reducing harm to the individual. Gantt charts and action plan matrixes can help teams track the major improvement actions, milestones, and progress toward meeting the completion time frames.

Organization Processes

• How does the proposed redesign element relate to other projects currently under way in the organization? Are there redundancies? • How does the redesign element affect other areas and health care processes? • What process-related changes might be required? • Can affected areas absorb the changes/additional responsibilities? Resources

• What financial resources will be required to implement the redesign element? (Include both direct and indirect costs—that is, costs associated with the necessary changes to other procedures and processes.) How will these resources be obtained? • What other resources (staff, time, management) are required for successful implementation? How will these resources be obtained? • What resources (capital, staff, time, management) are required for continued effectiveness? How will such resources be obtained?

In Chapter 7, you will learn how to analyze and test your redesigned processes to find out whether they will bring about the improvements you want.

Schedule

• In what time frame can implementation be completed? • How will implementation of this redesign element affect other schedules? How can this be handled? • What initial and ongoing training will be required? How will this affect the schedule and how can this be handled?

.

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Chapter 6: Redesigning the Process References 1. Croteau R.J., Schyve P.M.: Proactively error-proofing health care processes. In Spath P. (ed.): Error Reduction in Health Care. San Francisco: Jossey-Bass Publishers, 2000, pgs. 179–198. 2. Miller L.: Safety promotion and error reduction in perinatal care: Lessons from industry. J Perinat and Neonatal Nurs 17:128–138, Apr.–Jun. 2003. 3. Raouf E.N.: Error reduction in surgical pathology. Arch Pathol Lab Med 130:630–632 , 2006. 4 Massachusetts Coalition for the Prevention of Medical Errors: Safety First Alert: Errors in Transcribing and Administering Medications. http://www.macoalition.org/documents/SafetyFirst3.pdf (accessed Mar. 4, 2010). 5. Croteau R.: Proactive risk reduction: How it works. Trustee pgs. 25–27, May 2003. 6. AHRQ Patient Safety Network, Glossary. http://www.psnet.ahrq.gov/glossary.aspx (accessed Mar. 4, 2010). 7. Reason J.T.: Human Error. Cambridge, UK: Cambridge University Press, 1990. 8. Leonard M., Graham S., Bonacum D.: The human factor: The critical importance of effective teamwork and communication in providing safe care. Qual Saf Health Care 13:i85–i90, 2004. 9. Stevenson K., et al.: Features of primary health care teams associated with successful quality improvement of diabetes care: A qualitative study. Fam Pract 18:21–26, 2001. 10. Temkin-Greener H., Kunitz S.: Measuring interdisciplinary team performance in a long-term care setting. Med Care 42:472–480. May 2004. 11. Spath P.: Get more out of your FMEAs. Hosp Peer Rev 29:13–16, Jan. 2004.

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Analyzing and Testing the Process T

he failure mode and effects analysis (FMEA) team has identified elements of the process that merit redesign in order to reduce the risk of a failure that would or could harm someone or to mitigate the effect of an error that does reach someone. The team has evaluated and prioritized redesign elements. At this point, the team is ready to consider how to put the process redesign in place.

Organizing for Implementation The FMEA team is ready to start planning for the implementation of specific process redesign elements. The “what” issue has been determined through the prioritization process. Five questions need to be answered at this time: how, when, who, where, and how communicated?

How? How does the team expect, want, and need the improved process to perform? The FMEA team sets specific expectations for performance resulting from implementation of the redesign element. Without these expectations, the organization will not be able to determine the degree of success of the efforts. These expectations can be derived from staff expertise, consumer expectations, experiences of other organizations, recognized standards, and other sources. What sequence of activities and resources will be required to meet these expectations? How and what will the team measure to determine whether the process is actually performing at the expected level? The FMEA team needs outcome measures—specific measures of the performance of the redesigned or improved process—in order to determine whether expectations are met. These measures can be taken directly or adapted from other sources or newly created, as appropriate. It is important for the measures to be as quantitative as possible. This means that the measurement can be represented by a scale or range of values. For example, if improving staff competence in calculating medication doses is cited as a corrective solution for one failure mode, the measure should evaluate competence before and after each training or educational session. The measure might state that all staff should achieve at least a certain postimprovement test score, for example. At times, it might be difficult to establish quantitative measures; the redesign may simply seem to lend itself more to qualitative measures.









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Step 7: Analyze and test the process. After identifying the process changes, the FMEA team recalculated the risk priority numbers based on the predicted occurrence, detectability, and severity of the failure modes under the new processes. Through this analysis, the team estimated that the changes would reduce any risk by 36%. In addition, after implementing the changes, the team conducted additional chart audits to ensure that the discrepancies were being avoided. Also, the team spoke with the lab techs and nursing staff to determine whether staff was receiving all the necessary information to do their jobs. “There was a learning curve,” says Maribeth Derringer, director of quality management, “but overall, the changes went smoothly.”

Quantification of improvement is critical, however. Even when solutions can be measured only in terms of risk-reduction potential, it is important to try to quantify such potential as much as possible through concrete measures.

When? Next, the FMEA team defines when the organization must meet its redesign goals. What time frame will be established for implementing the redesign elements? What time line will be established for each activity in the steps along the way? What are the major milestones and their respective completion dates? Who? Who is closest to this process and therefore should “own” “own” the redesign element? Who should be accountable at various stages? The success of an improv improvement ement effort hinges on involving the right people from all disciplines, services, and offices involved in the redesign element being addressed. The group that redesigns a process step or link should include the people responsible for the process step or link, the people who will carry out the step or link, and the people affected by the step, link, and overall process. Hands-on participation in the redesign by end users is critical both to consideration of all relevant end-user issues and facilitation of ultimate end-user buyin. Leaders must ensure that the people involved have the necessary resources and expertise.

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Furthermore, their authority to make changes should be comFurthermore, mensurate with their responsibility for process improvements. While regular feedback and contact with managemen managementt are important, rigid control can stifle creativity. Once each step has a designated responsible party, it is important to emphasize the necessity of completing the assigned actions. If people are not aware of the importance of their roles, actions could get delayed, forgotten, or just not done. Responsible parties should be given the expectation of what needs to be accomplished and by when, with regular opportunities to report the status of the activity.

Where? Where will the redesign element be implemented on a pilot test basis? Will its pilot testing be in a selected location with a selected care recipient population or selected staff members? Where will it be implemented organizationwid organizationwidee following pilot testing success? Is the location, target population, or target staff of the redesign element likely to expand with success? How to Communicate Change Throughout the FMEA, the team communicates its conclusions and recommendations as outlined early in the process when the team determines its scope and boundaries. boundaries. Thorough communication is critical to success. After the team identifies the redesign strategies it wishes to pursue, the team should provide leadership with its redesign recommendations.

Chapter 7: Analyzing and Testing the Process

Case Study Conducting FMEAon the Opioid Prescribing Process at the University of Texas M.D. Anderson Cancer Center Step 7: Analyze and test the process. The processes were rolled out in stages, for two reasons. First, the team wanted to observe the changes in practice and make revisions if necessary. For example, after staff used the redesigned prescribing order sets, it was decided that the form should include standard dosing to make it easier to complete. Second, the team wanted to identify metrics that could be monitored to make it possible to compare future goals and ensure that goals were still being met. The metrics include the following: 1. Adverse drug events (ADEs) (ADEs) resulting in harm harm related to opioids administration 2. Number of days without harm from an opioid-related ADE 3. Percent of patients receiving opioids who receive subsequent treatment with Naloxone (a medication used to counter the effects of opioid overdose) 4. Number of opioid doses between a subsequent ADE with harm

Generally, a short written report provides leaders with the information they need. The FMEA team should consider carefully how and to whom the report is to be presented. It should consider the following when communicating about process redesign: ■ How will implementation of the redesign be communicated throughout the organization? Who needs to know? ■ What communication vehicles will the team use for various audiences (individuals both directly and indirectly affected by the redesign)? ■ Participants during a formal oral presentation should include those whose approval and help is needed and those who could gain from the team’s recommendations.

Testing the New Process Once the redesigned process has been planned for, it is important for the team to test it before full-scale implementation begins. Not only should a team test any new processes that are created, but it should also evaluate the effect of new subprocesses on the larger process before implementing changes. 1 This can be an instructive process and less expensive than a premature adoption adoption of a well-intended but faulty design. 2 With any significant redesign, unexpected and unintended consequences can occur. In some cases, the new risk may be more serious than the potential risk the process is intended to prevent. 3 When redesigning a process, the new redesign may address one of the several risk factors involved in the process,

such as variable input, lack of standardization, hierarchical interaction, and so on, but in the process it may introduce other risk factors, including the following: ■ Input/output mismatch. mismatch. Each step in a process requires an input and yields an output that is often the input for another step.4 Redesigning a subprocess without paying attention to its interrelationships can result in a mismatched input from the upstream process or a faulty input to the remaining downstream downstream process. ■ Oversimplifica Oversimplification. tion. An organization may eliminate necessary safeguards, such as protective redundancies, in trying to reduce steps. complexity. This is the opposite of oversimplifica■ Added complexity. tion. Complex processes are more prone to failure than simple ones; additional steps may come with attendant failure modes. ■ Reliance on unreliable systems. A form of excessive complexity, this is seen in many technical solutions (for example, implementing computerized provider order entry without adequate decision support software) or in checks that are not independent and therefore not truly redundant. ■ Tight coupling. Failure often occurs at the point of connection (coupling) in a series of actions. If the steps in the process follow so tightly that variation cannot be recognized and responded to before the next step begins, the process eliminates opportunities to identify failures and to intervene to protect. ■ Variation from usual or intuitive behavior. Changing a

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Case Study Conducting FMEA to Prevent Pressure Ulcers at Gaylord Hospital Step 7: Analyze and test the process. During the testing process, the team checked each patient weekly to track the effectiveness of the new procedures to collect data to show staff how their efforts were improving patient safety. During one of the testing weeks, a failure occurred due to staff vacation. That told the team that the design of that process was person-dependent and gave them the opportunity to change it. Before the new processes were implemented, the pressure ulcer rate was over 40%; one month later, it was below 30%; and four months later the rate was under 10%.

process step from accepted guidelines of care can introduce human error. This is particularly dangerous when the individuals involved (such as medical staff) function in different settings that have contrasting policies. For example, a policy of marking the opposite side from an intended surgery rather than marking the intended site introduces a risk for error. When testing a new process or subprocess, several strategies can ensure the highest likelihood of success: conducting a paper test FMEA, simulation, and pilot testing. Each of these strategies must involve input from a multidisciplinary team that has a clear understanding of the problematic process and the proposed redesigned one.

Paper Testing The first strategy the team might use may be to analyze the redesigned process on paper. FMEA again provides an approach for doing this. Fault-tree analysis and other analytical techniques can also be used to test the redesigned process on paper. In applying FMEA to the redesigned process, the team again completes steps 3 (diagram the process, brainstorm potential failure modes, and determine their effects) and 4 (prioritize failure modes) of the FMEA process. A new flowchart of the redesigned process is appropriate at this point. It should indicate the new steps and links between steps proposed by redesign improvements. Teams can brainstorm about new failure modes and effects that might be introduced by the new design elements. It can consider possible new failure modes in subprocesses and related processes.

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Then, to determine whether the proposed redesign will prevent the failure entirely (decrease likelihood of occurrence), prevent the failure from reaching the individual (increase the probability of detection), or protect the individual if the failure occurs (decrease the severity of the effects), the team should calculate a new criticality index or risk priority number (RPN) for the failure mode. Design improvements should bring a significant reduction in the criticality index or RPN. What is significant? Is a 50% reduction reduction the goal? Or Or would the team be willing to implement a redesign with the goal of achieving a 30% lower RPN, for example? Each team defines this for a particular process. Not every process will have the same goal. Factors such as severity, occurrence, detection, and so on affect the risk-reduction goal for the process.

Simulation A team may be able to use simulation to test a new design within a risk-free environment. Simulation allows the organization to experience the implications of a redesign without risk to the individual receiving care. 2 A paper stress test or computer-based simulation exercise can help a team anticipate the full range of decision-making and performance issues that might arise with a new process design. Such a test involves playing out how the new process will function when several worst-case conditions or variables converge at the same time. For example, a computer-based test on patient-controlled analgesia could examine the individual and collective effects when several failure modes occur in one patient case, such as a wrong analgesic or dose selection, errors entering the pharmacy computer from an illegible order, and an inadequate check of the patient-controlled analgesia pump, pump, resulting in the wrong flow rate.5 “A simulation can reveal potential unanticipated side


Case Study Conducting FMEA on Medication Requests at Amerikan Hastanesi

Step 7: Analyze and test the process. After implementing the process changes, Amerikan Hastanesi’s FMEA team conducted another risk analysis and found that the total risk priority score had been reduced by more than 50%. See the following table for the severity and occurrence ratings for the redesigned processes. Note: The failure modes were listed in order of risk priority score, highest to lowest. Because some steps repeat in this list (they have multiple failure modes that received different risk scores), the order number in the first column serves as a reminder of the order of the steps in the overall process. Order Process Rank Step

4

5






Main Causes


Sev.

Occ.

RPS

Mix-up of concepts of “Emergency” and “Urgent” Non-detection of state of emergency

1. Clarification of emergency-urgent concepts 2. Informing employees 3. Transition to pneumatic system

5

2

10


1. Setting up a division of labor bulletin board 2. Separating work spaces at the Pharmacy 3. The Pharmacy’s contacting the floors first 4. Sending out reminders or e-mail for timely requests of narcotics 5. Encouraging the accompanying of Physicians on patient visits;adding this to the employees’ performance evaluation system 6. Pharmacy orientation program 7. Contacting the Physician in the event of an incomplete order. 8. Checking and arranging shelves where medication is stored at the Pharmacy to improve visual display and make high-risk medications stand out

9

5

45

(continued)

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Case Study Conducting FMEA on Medication Requests at Amerikan Hastanesi, continued Order Rank

5

1

Process Step


Orders are Drug-drug intercontrolled and action check is prepared by not made Pharmacy staff

Order is sent to Chemotherapy Nurse


Main Causes


Sev.

Occ.

RPS

Leaving implementation for later system is not clearly known

1. Review of control system 2. Defining major drug–drug interactions, adding information about interaction on the Physician's order, writing of a Pharmacist's note 3. Writing of the Pharmacist’s note in red so that it is better seen 4. Sharing of the interaction table over Ahnet

5

3

15

Writing of orders without calculating Physician’s using their own prescriptions Not checking medications coming from home

1. Pharmacist’s checking medications coming from home in the Chemotherapy Unit 2. Pharmacist’s checking medications brought in from home by patients on inpatient floors, in accordance with the admissions list sent in daily by Patient Admissions, and writing “Has been controlled” on and signing the “Discharge Plan” form 3. Adding an Oncologist to the team

9

3

27

effects of variations in the process and, in the case of computer simulation, has the further advantage of allowing things to play out in compressed time to reveal long-term effects,” note Croteau and Schyve.4

Pilot Testing If the paper-tested or simulated process redesign looks promising, conduct a pilot test to determine the real-world effectiveness of the new process. Through pilot tests, a team implements the redesign on a small scale, monitors its results, and refines the redesign as necessary, without taking the risks associated with full-scale implementation. This enables the team to 122

ensure that the redesign is successful before committing significant resources to the redesigned process. This is a good time to examine any human factors issues present in the new process. For example, the organization might look at how the new process intersects with the behaviors, limitations, and skill sets of the people who are involved with the process. This is also a good time to gather feedback from staff involved in the process. Because they are the ones who will be carrying out the process, it is important to get their feedback. Pilot testing also aids in building support for the new design, thereby facilitating buy-in by opinion leaders.




Step 7: Analyze and test the process. Since the changes were developed, the team has used the Plan-Do-Study-Act (PDSA) reporting form to test the new processes. As each change was introduced, a PDSA was conducted to see if it was working as expected. A review of 20 client charts showed a steady increase in completion of the psychosocial assessments.

To help gauge staff perceptions of the redesigned process, organizations might want to consider a pre-and postsurvey of staff involved in the pilot test. This can provide information about how the group feels about the process before and after the revisions. It can help gauge staff approval and buy-in and identify any potential barriers to implementation. Measurement is an important aspect of any pilot test. Outcome measurement is used to learn about the results of a process, whereas process measurement provides information about what causes those results. When testing a redesigned process, a team can use both outcome measures and process measures. However, use of process measures ensures a focus on more than just subsequent failures. Measuring factors such as consistency, completeness, accuracy, and timeliness provides greater assurance about the effectiveness of the new design than simply observing whether an adverse occurrence happened during the pilot test. An example of a process measure is “number or percentage of individuals over 65 years of age having medication monitoring for high-risk drugs that can decrease renal function.” The process measured is medication monitoring of high-risk drugs. An example of an outcome measure is “percentage of individuals at risk for skin breakdown who actually experience skin breakdown.” In developing measures for pilot tests, the FMEA team should answer the following questions: ■ How will we measure whether the change is successful in preventing future failure? (Select the indicators.) ■ What will be measured? (Define the data elements.) ■ Who will perform the measurement? (Define the data collection process.) ■ With what frequency will the measurement be performed?

Data Collection Strategies There are a variety of ways an organization can collect data, including the following: ■ Record review ■ Pre-and post-survey ■ Reporting system ■ Observation ■ Focus group ■ Attendance at education programs ■ Competency assessment It is helpful to coordinate any ongoing measurement with data collection already taking place as part of the organization’s everyday activities. In documenting the outcomes of the test, an organization might use several different tools, such as flowcharts, cause-andeffect diagrams, Pareto charts, control charts, scatter diagrams, and histograms. (See Chapter 5 for complete definitions of these tools.) Chapter 8 provides more information on measuring outcomes.

The Plan-Do-Study-Act (PDSA) Cycle The analysis, testing, implementation, and monitoring of a process are all linked, and a problem identified in one phase can affect all the other phases. To help teams keep track of the two final steps of the FMEA process, the team might want to consider using a quality improvement tool such as the PDSA cycle. A well-established process for improvement that is based on the scientific method, the PDSA cycle (also called the PDCA cycle, with the word check replacing the word study) is attributed to Walter Shewhart, a quality improvement pioneer with Bell Laboratories in the 1920s and 1930s, and is also widely associated with W. Edwards Deming, a student and

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Sidebar 7-1.

Components of the

Sidebar 7-2.

Key Questions to Consider

PDSA Cycle

During the Plan Stage

Plan

• How was a design or improvement strategy selected for testing? • Is there knowledge-based information (for example, from the literature, other organizations, or other external sources) supporting the new or improved process? • What issues in the external environment (such as economy, politics, customer needs, competitors, regulations) will affect the performance of the new or improved process? • What issues in the internal environment will affect the performance of the new or improved process? • Who is (are) the customer(s) of the process? • What is the current process? • What is the desired process? • Who are the suppliers of the process? • What changes will have the most impact? • Is there a plan for testing the design or improvement? • Is there a time line for testing? • What data will be collected to determine whether the test was successful (that is, whether the objective was met)? • How is it determined that the measures actually address the desired issue? • Can the measures used actually track performance? • How will data be collected? • Who will collect data? • Are systems in place to support planned measurement? • Is benchmarking feasible for this initiative? • Are the right people involved? • What resources are needed to design or redesign the process? What resources are available?

❑ Develop or design a new process or redesign or improve an existing process ❑ Determine how to test the new or redesigned process ❑ Identify measures that can be used to assess the success of the strategy and whether the objective was reached ❑ Determine how to collect the measures of success ❑ Involve the right people in the development and testing ❑ The data intended for collection are available ❑ Results can be reported in a way that is useful to the organization and other interested customers

Do ❑

Run the test of the new or redesigned process, preferably on a small scale ❑ Collect data on the measures of success Study ❑

Assess the results of the test ❑ Determine whether the change was successful ❑ Identify any lessons learned Act ❑

Implement the change permanently

or

❑

Modify it and run it through another testing cycle

or

❑

Abandon it and develop a new approach to test

later a colleague of Shewhart. Deming made the PDCA cycle central to his influential teachings about quality. The cycle is compelling in its logic and simplicity. The plan-do-study-act (PDSA) approach to performance and quality improvement includes identifying design or redesign opportunities, setting priorities for improvement, and implementing the improvement project.

operation. The list of proposed improvement actions should be narrowed to a number that can be reasonably tested—perhaps between two and four.

During the plan step, a team creates an operational plan for testing the chosen improvement actions. Small-scale testing can help to determine whether the improvement actions are viable, whether they will have the desired result, and whether any refinements are necessary before putting them into full

During the planning stage, several issues should be resolved: ■ Who will be involved in the test? ■ What must they know to participate in the test? ■ What are the testing timetables? ■ How will the test be implemented? ■ Why is the idea being tested?

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Sidebar 7-3.

Key Questions to Consider

During the Do Stage

• Was the testing plan followed? • Were needed modifications discussed with the appropriate people? • Was data collection timely? • Was data collection reliable?

What are the success factors? ■ How will the process and outcomes of the test be measured and assessed? ■

The do step involves implementing the pilot test and collecting actual performance data. During the study (or check) step, data collected during the pilot test are analyzed to determine whether the improvement action was successful in achieving the desired outcomes. To determine the degree of success, the team compares actual test performance to desired performance targets and baseline results achieved using the established process. The next step is the act step, which involves taking action. If the pilot test is not successful, the cycle repeats. Once actions have been shown to be successful, they are made part of standard operating procedure. The process does not stop here. The team continues to measure and assess the effectiveness of the action to ensure that improvement is maintained. The components of the four-step PDSA cycle as they relate to designing and improving processes appear in Sidebar 7-1, page 124. A single initiative can involve a number of different testing phases or different change strategies and can there fore require the use of consecutive PDSA cycles. To help teams and individuals involved in design or improvement initiatives apply the method effectively, the organization, depending on the nature of the improvement project, might want to consider the questions outlined in Sidebars 7-2 through 7-5, pages 124–125, at each step of the method.

Sidebar 7-4.

Key Questions to Consider During the Study Stage

•

• • • • • • • • • •

•

How will the test data be assessed? What process should be used? Who should be involved in data analysis? What methods or tools should we use to analyze data? Is training needed on data analysis methods and tools? Is comparative data (internal or external) available? Does data analysis lead to an understanding of problem areas? Is data analysis timely? Are the results available soon enough to take needed actions? Do the test data indicate that the design or improvement was successful? What lessons were learned from the test? What measures will determine whether to implement the tested design or improvement on a permanent basis? How and to whom will the results of assessment activities be communicated?

Sidebar 7-5.

Key Questions to Consider During the Act Stage

• Should changes be recommended to others (for example, for purchasing equipment or implementing specific processes)? • How will these changes be communicated to the appropriate people? • Is any education or training needed? • How will gain be maintained and backsliding be prevented? • What measures should be used to assess the performance of the new or improved product or process? • Should any of the measures identified here be included in ongoing measurement activities?

Now that the redesigned processes have been created, Chapter 8 will teach you how to implement them and monitor their performance.

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References 1. Spath P: Home study program: Using failure mode and effects analysis to improve patient safety. AORN J 78:15–44, Jul. 2003. 2. Croteau R.: Proactive risk reduction: How it works. Trustee pgs. 25–27, May 2003. 3. Joint Commission Resources: Taking care not to introduce new risk in redesigns. The Joint Commission Benchmark 4:8, Nov. 2002. 4. Croteau R.J., Schyve P.M.: Proactively error-proofing health care processes. In Spath P. (ed.): Error Reduction in Health Care. San Francisco: Jossey-Bass Publishers, 2000, pgs. 179–198. 5. Institute for Safe Medication Practices: Example of a Health Care Failure Mode and Effects Analysis for IV Patient Controlled Analgesia (PCA), 2002. http://www.ismp.org/Tools/FMEAofPCA.pdf (accessed Mar. 5, 2010).

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Chapter 8

Implementing and Monitoring the New Process O

nce the process has been successfully tested, it is time to implement it on a larger scale and actively manage the change process. Implementing the redesigned process is all about introducing change into ongoing health care processes. Eugene Nelson and his colleagues suggest the following actions a failure mode and effects analysis (FMEA) team might take to help manage and lead the change process 1: ■ The first action is to establish a sense of urgency about the needed redesign. This can be accomplished by identifying the “best practice” and the gap between the organization’s process and the bestpractice process, identifying the consequence of being less than the best, and exploring sources of complacency. ■ The second action is to create a guiding coalition. This involves finding the right people to effect the change, creating trust within this group, and establishing a shared goal about the need for process redesign. ■ The third action is to develop a vision and strategy about the redesigned process that is easily pictured, attractive, feasible, clear, flexible, and communicable. ■ The fourth action is to communicate the changed design in a way that is simple, works in multiple forms, involves doing instead of telling, explains inconsistencies, and involves give and take. The FMEA team develops and implements plans that address how the redesigned process will be communicated organizationwide, department by department, or discipline by discipline, as appropriate. ■ The fifth action is to empower broad-based action by communicating a sensible vision to employees involved in the redesign process, making organization structures compatible with action, providing needed training, aligning information and human resources systems, and confronting supervisors who undercut redesign change. ■ The sixth action is to generate short-term wins by fixing the dates of certain components of the process redesign, doing the easy tasks first, and using measurement to confirm process change. ■ The seventh action is to consolidate gains and produce more change by identifying true interdependencies and smooth inter-









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Step 8: Implement and monitor the new process. The FMEA team met frequently when the changes were first implemented, then gradually spread out the time between meetings. Now the team conducts a chart audit once a quarter and reports to the performance improvement team. The latest audit found that the completion rate was 96%. However, in the process of that PDSA, the team uncovered some other areas of concern. For example, the team learned that while assessments were being completed at a higher rate, the rate of completion for treatment plans saw a decrease. This issue was discussed in a meeting with TCMs, and without making any process changes, the rates began to increase. This indicates that periodic reminders and involvement from supervisors can be valuable. Staff members also suggested that other types of reminders for patients could be explored, as mailed reminders might not be effective due to client frequency of address changes, if an address is at all. Therefore, the team plans to conduct another PDSA to focus specifically on the effectiveness of the mailed reminder cards. Geraty and his team will continue to monitor assessment completion rates each quarter to determine whether additional adjustments are needed to maintain high levels of compliance.

connections, eliminating unnecessary dependencies, and identifying linked subsequent cycles of change. ■ The eighth and final action is to anchor new approaches in the culture with results, conversation, turnover, and succession.

Implementing the New Process How do FMEA teams implement the redesigned process? They take those actions outlined above. In addition, they define specific activities that will need to be carried out to implement the process redesign. These may or may not involve sequential steps. They determine the resources needed to implement the redesign. They establish the time frame for implementing the overall redesigned process and each component redesign step. They define the major milestones and their respective completion dates, the person responsible for each step or milestone, and the person responsible for any corrective actions that may be needed. They identify barriers to change and countermeasures to overcome such barriers. Once all of these activities are performed, the team begins the implementation process.

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Measuring and Monitoring As an FMEA team implements a redesigned process, it also implements the measurement or monitoring plan it developed during the pilot testing stage. Continued monitoring and measurement helps to ensure that the desired level of performance of the redesigned process or subprocess will be maintained. It also answers the questions “How is the new or revised process working?” and “What impact, if any, is it having on the larger processes of which it is a part?” Effectiveness

Strategies for Creating and Managing the Change Process • Establish a sense of urgency • Create a guiding coalition • Develop a vision and strategy • Communicate the changed vision • Empower broad-based action • Generate short-term wins • Consolidate gains and produce more change • Anchor new approaches in the culture

Chapter 8: Implementing and Monitoring the New Process

Case Study Conducting FMEA on Medication Requests at Amerikan Hastanesi Step 8: Implement and monitor the new process. To ensure that positive progress continues to occur, the Amerikan Hastanesi FMEA team developed guidelines and strategies for monitoring the changes. The table that follows describes those monitoring plans. Note: The failure modes were listed in order of risk priority score, highest to lowest. Some steps repeat in this list due to multiple failure modes that received different risk scores. The order number in the first column served as a reminder of the order of the steps in the overall process. Order Rank

4

Process Step

Porter leaves order at the Pharmacy.


An emergency order is left for later.

Main Causes



How Will Performance be Monitored?

1. Clarification of emergencyurgent concepts 2. Informing employees 3. Transition to pneumatic system

The concept of “emergency” pertains only to the medications found in the emergency bags and emergency carts on hospital floors; urgent drawers have been developed for medications meant to increase the quality of patient care and satisfaction on the floors. This will reduce errors due to rapid preparation of medications in the preparation stage (Plan No. 1.PL.6140.001 "Medications Management Plan" has been added). Pneumatic system has begun to be implemented.

(continued)

measures include both outcome and process indicators, as described in Chapter 7. The FMEA team is usually responsible for designing and carrying out the measurement activities that are necessary to determine how the redesigned process performs. Organizations may

have various experts who can help design measurement activities, including experts in information management, quality improvement, and the function to be measured. The team can request the input of these individuals on an ad hoc basis. Information management, quality improvement professionals, and those responsible for carrying out the process being meas-

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Case Study Conducting FMEA on Medication Requests at Amerikan Hastanesi, continued Order Rank

5

130

Process Step




Main Causes


How Will Performance be Monitored?

Confusion in division of labor Heavy telephone traffic Divisions stemming from Technicians’ training Carrying out all procedures at the same desk Narcotics not being requested promptly Magistral medications not being requested promptly Illegible order Placing returned medication on wrong shelf Incomplete writing out of order

1. Setting up a division of labor bulletin board 2. Separating work spaces at the Pharmacy 3. The Pharmacy’s contacting the floors first 4. Sending out reminders or email for timely requests of narcotics 5. Encouraging the accompanying of Physicians on patient visits. Adding this to the employees’ performance evaluation system. 6. Pharmacy orientation program 7. Contacting the Physician in the event of an incomplete order. 8. Checking and arranging shelves where medication is stored at the Pharmacy to improve visual display and make high-risk medications stand out

1. Daily division of labor has started to ensure that Pharmacist is not distracted during medication preparation stage 2. Common work spaces for drug preparation in the Pharmacy increases the risk of mix-ups. A separate work space has been developed for each Pharmacist. 3. Employees have been informed that the Pharmacist must first contact the person concerned in inappropriate situations 4. Employees have been informed about placing timely requests for narcotics 5. Accompanying Physician on patient visits is a performance indicator that is recorded on each floor 6. As of May 25, 2008, an intradepartmental orientation program has begun to be implemented in the Pharmacy department 7. Employees have been informed that criteria for accepting orders have been determined and that each order is to be checked upon arrival at the Pharmacy; Physicians to be contacted in the case of inappropriately submitted orders 8. Incorrectly dispensed medications (2007–April 2008) have been determined and the storage areas and packages at the Pharmacy have been checked


Case Study Conducting FMEA on the Opioid Prescribing Process at the University of Texas M.D. Anderson Cancer Center Step 8: Implement and monitor the new process. Since implementation, the team has been relying primarily on internal incident reporting to determine whether the redesigned processes are working. “We think that we made a favorable impact because we’ve had reduced rates of patients being dangerously oversedated and needing to be in the ICU,” says Allen W. Burton, M.D. “We’re not sure yet if this is a short-term observation or if it’s a long-term change. We don’t have a significant amount of long-term data. We need more data. We’re also still working on developing some metrics, and we’re looking at ways to measure some things that seem a little more intangible. For example, we’re trying to determine how to track the outcome of the educational plan.” Root Cause

Action Plan

Short or Long Term

Implementation Follow-Up

Omission errors secondary to automatic stop order (ASO)

Change 7-day ASO to 30day ASO for Schedule II Controlled Substances

Short term

No reported omission errors involving opioids since September 2008

Suboptimal patient involvement in medication histories

Promote use of comprehensive Patient Home Medication List

Short term

“Education Before Medication” Patient Safety Campaign launched October 2008

Suboptimal medication reconciliation by clinicians

Develop electronic prompt to increase accuracy of medication reconciliation

Short term

Prompt went online

Short term

Revised and implemented order sets online, that included more clear and concise medication contraindications

Confusing epidural and patient-controlled analgesia order sets

Revise order sets

Lack of electronic medication administration record

Orient current staff to realtime “Pharmacy” folder in electronic record

Short term Long term

Presentation at Clinical Manager’s Forum Faculty Road Show Researching EMR capabilities

Lack of computerized order entry

Implement CPOE

Long term

Researching CPOE capabilities

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Case Study Conducting FMEA to Prevent Pressure Ulcers at Gaylord Hospital Step 8: Implement and monitor the new process. To continue monitoring the new processes, the Gaylord wound care team evaluates the patient documentation on a weekly basis, evaluates any wounds every week, reviews the assessments at admission, and considers the risk assessment scores for patients who come to Gaylord with wounds or develop wounds while in the facility. The pressure ulcer prevalence rate continues to be lower than most other long-term acute care hospitals—although they’ve recently seen a slight uptick for the same reasons the hospital saw the initial rate increase that motivated the FMEA project. “We were down to 3.5% for a long time, and we felt like we could maintain that,” says Trigilia. “But now the severity of illness in the patients we’re seeing has increased again. Now patients are staying for many months and requiring mechanical ventilation for more time, significant diagnostic testing, and compressor therapy. Along with that goes the higher rate of skin breakdown.” Currently, the hospital’s pressure ulcer prevalence rate is about 8%, which is still significantly lower than the average, which is more than 25% for long term acute care hospitals. “Now that we have wound care processes in place and a trained wound care team, we are ready this time to make any changes necessary to keep our prevalence rates down,” notes Trigilia.

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25

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5 5 6 6 6 6 6 0 6 - 0 6 6 6 5 0 6 0 6 0 6 5 0 5 r - 0 e r - 0 r - 0 5 r y - 0 r y - 0 c h - 0 r i l 0 r - 0 e r - 0 r - e r - 0 t 0 y - n e - u l y - s t 0 e e r y e a l e s a a r b b u b b b J u g m b t o b u M u u a o b e J u A p J u u g m m M m O c t v e m e m J a n e b r A p t e O c o v e e c e A p t e c o F N N D S e D e S e

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Figure 8-1. Gantt Chart

This type of chart can be helpful in implementing and monitoring improvements. The purpose of a Gantt chart is to graphically depict the timeline for long-term and complex projects, which enables a team to gauge its progress. The following steps are involved in creating a Gantt chart: 1. Agree on start and stop dates for the project and outline the project’s major steps. 2. Draw a time line. Leave enough space in the time line to write beneath each time period. 3. Write the first step of the project under the appropriate time period. Enclose it in a rectangle that is long enough to stretch across the length of time estimated for completion. Write entries in a stair-step fashion, each step below the one before it, so that overlapping steps are clearly indicated. 4. Follow step 3 for each of the succeeding steps. Color in the rectangles as each step is completed. If the project is very complex and lengthy, consider creating a Gantt chart for each phase or each quarter of the year..

ured are key players in data collection and analysis. The people involved will vary widely, depending on the specific organization, the function being measured, and the measurement process.

Analyzing Data

A team that is on track with their efforts to measure the effectiveness of redesign initiatives should be able to answer the following questions affirmatively: ■ Do we have a plan for use of the data? ■ Are the data collected reliable and valid? ■ Have we planned for ease of data collection? ■ Have we defined key elements required for improvement? ■ Are we avoiding a “data rich/information poor” syndrome?

After data are collected as part of measurement, they must be translated into information that the FMEA team can use to make judgments and draw conclusions about the performance of the process redesign. This assessment forms the basis for further actions taken with, or modifications of, the redesign effort. Numerous techniques can be used to assess the data collected. Most types of assessment require comparing data to a point of reference. These reference points may include, but are not limited to, the following: ■ Internal comparisons

■

Have we designated a key point for information dissemination?

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Case Study Conducting FMEA on the Neonatal Intensive Care Unit Laboratory Test Ordering Process: Miami Valley Hospital Step 8: Implement and monitor the new process. Past failures in this area were anecdotal; the organization didn’t have any formal data on the lab/neonatal intensive care unit inefficiencies. Since the changes, the number of such problems annoted has been significantly reduced. As of the third quarter of 2007—shortly after the redesigned processes were put into place—no duplicate lab orders were reported. The organization continues to monitor the process and plans to conduct another FMEA to ensure that the process is still effective. In addition, the team worked to address some of the other issues that arose during this FMEA project. For example, some nurses expressed concern about the removal of adhesive bandages from patients’ delicate skin and about the bruising caused by the type of lancet used for heel sticks. As a result, a group reviewed available products to ensure that the least amount of discomfort is caused to the babies.

Aggregate external reference databases ■ Practice guidelines/parameters ■ Desired performance targets, specifications, or thresholds ■

Internal Comparisons For internal comparisons, a team can compare its current performance with its past performance by using tools such as run charts, control charts, and histograms. These are helpful in comparing performance with historical patterns and assessing variation and stability. They show changes over time, variation in performance, and the stability of performance. External Comparisons Assessment is not confined to information gathered within the walls of a single organization. To better understand its level of performance, an organization can compare its performance against reference databases, professional standards, trade association guidelines, and other sources.

The FMEA team can also compare the organization’s performance with that of other organizations. Expanding the scope of comparison helps an organization draw conclusions about its own performance and learn about different methods to redesign and implement redesigned processes. Aggregate external databases take various forms. Aggregate, risk-adjusted data about specific indicators help each organization set priorities for improvement by showing whether its current performance falls within the expected range.

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One method of comparing performance is benchmarking. Although a benchmark can be any point of comparison, most often it is a standard of excellence. Benchmarking is the process by which one organization studies the exemplary performance of a similar process in another organization and, to the greatest extent possible, adapts that information for its own use. While benchmarking can be very valuable, it is important for organizations to give special consideration to what is benchmarked and how data are interpreted. 2 When determining sources against which to benchmark, an organization should make sure that the definitions of data to be collected are the same; otherwise, the organization is not comparing apples to apples. Data can also be deceiving and in fact can actually paint a picture of a problem when there is not one. Consider an organization whose data reflect a high number of problematic incidents. Some organizations may have more sophisticated cultures of reporting than others, so the higher numbers might not necessarily mean the organization has more problematic incidents; it may merely reflect the open reporting of the culture. Likewise, an organization with a low number of incidents does not necessarily have more effective safety processes. Practice Guidelines or Parameters Practice guidelines or parameters, critical pathways, and other standardized care procedures are very useful reference points for comparison. Whether developed by professional societies


Sidebar 8-1.

Six Sigma

One commonly used, proactive approach to reducing error is Six Sigma, a quality improvement method developed by the manufacturing industry that aims to get as close to “zero defects” as possible. This methodology focuses on enhancing reliability in processes and was heavily inspired by decades of other quality management programs such as Quality Control, Total Quality Management, and Zero Defects. Sigma is another word for standard deviation. The higher the sigma number, the fewer the defects. At Six Sigma, the level of defects is 3.4 in 1 million. As a comparison, most companies operate at around three or four sigma. Six Sigma methodology is a data-driven, problem-solving approach based on the idea that if you can measure how many defects are in a process, you can then figure out how to eliminate them in a systematic way. A defect can mean you are failing to meet a customer’s needs. In health care, this customer may be a patient, client, resident, a family, or a staff member. See Sidebar 8-2, page 136, for an example Six Sigma project cycle. Six Sigma relies heavily on statistical analysis of data. The following are the five basic steps involved in the methodology: 1. Define the problem. This step involves identifying the project, the goals and objectives of the project, the current knowledge about the project, the business benefits

of the project, and a timeline for project completion. 2. Measure . This phase uses flowcharts, cause-and-effect diagrams, and other quality improvement tools to collect data and identify or measure contributions to a process that can cause problems. 3. Analyze. This phase requires teams to analyze the data to see how a process is currently being performed and identify potential areas of failure. This stage also involves determining how potential issues should be addressed and how difficult it will be to address them. 4. Improve. In the improvement phase, teams must show evidence-based improvement as a result of implemented ideas. 5. Control. In this phase, any improvements are sustained. Six Sigma helps organizations do the following: • Identify what is most important to the customer— whether the customer is the individual receiving care, staff, or leadership of an organization. • Identify process defects. • Measure process defects versus opportunities. • Eliminate process defects. • Yield sustainable change through process design.

Sources: Six sigma gives leaders tools for improving processes in OR. OR Manager 20:13–15, Jun. 2004; Six sigma success: 100% compliance in 3 months. Healthcare Benchmarks Qual Improv pp. 52–55, May 2004.

or in-house, these procedures represent expert consensus about the expected practices for a given diagnosis or treatment. Assessing variation from such established procedures can help a team identify how its process varies from the norm. Desired Performance Targets A team may establish targets, specifications, or thresholds for evaluation against which it compares current performance. Such levels can be derived from professional literature or expert opinion within the organization.

If the redesign is not achieving its goals, modifications may need to be made. The FMEA team needs to circle back to confirm root causes of the failure, identify a risk-reduction strategy, design an improvement, implement the redesign, and measure the effectiveness of that redesign over time.

In addition, other commonly used methods of error reduction that are used in many industries include Six Sigma, Lean Management, and Robust Process Improvement™, a process improvement methodology used by The Joint Commission that combines Six Sigma and Lean Management. Sidebars 8-1, 8-2, 8-3, and 8-4, pages 135–138, describe these strategies in more detail.

Results The following are results that some organizations have discovered after analyzing processes post-FMEA: ■ Massachusetts General Hospital, a 900-bed urban academic medical center, conducted a FMEA in its radiology department to improve screenings for patients with diabetes before interventional procedures and safety monitoring of inpatients during weekend hours. Six months after

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Sidebar 8-2.

Example Six Sigma Project Cycle

An integral part of the Six Sigma methodology is Define, Measure, Analyze, Improve, Control, also called DMAIC. DMAIC provides a useful framework for conducting Six Sigma projects and is sometimes used for project control for a process or system that is already in place. Criteria for completing a particular phase can be defined and the process can be reviewed to determine if all objectives have been met.

Define the goals of the improvement activity. Include at the top of the goals the strategic objectives of the organization. The next level should be the operational goals. The project level goals might be to reduce the defect level for a particular process. Obtain goals from direct communication with the individual receiving care, treatment, or services, project owners, and staff. • What is the business case for the project? • What is the current state of the project or process? • What will be the future state? • What is the scope of the project? • What are the deliverables? • What is the due date?

Measure the existing system or process. Establish valid and reliable metrics to monitor progress. Begin by determining the current baseline, and use descriptive data analysis to help you understand the data. • What are the key metrics? • Are the metrics valid and reliable? • How will we measure progress? • How will we measure success?

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Analyze the system or process to eliminate any gaps between the current performance of the process and the desired goal. • Analyze current performance. • Is the current statistic good or can it be improved? • Who will help make changes? • What resources are needed? • What could cause this change to fail? • What are the obstacles in completing this project?

Improve the system or process. Be creative in finding new ways to do things better. Use project management and other management tools to implement the new approach. • What is the work breakdown structure for this project? • What activities are necessary to meet goals? • How will we reintegrate the subprojects? • Are there any unanticipated consequences?

Control the new process. Institute the improved process by modifying policies, procedures, budgets, and other management systems. Use statistical tools to monitor stability. • How will we control risk, quality, scope, schedules, cost, and changes to the plan? • What types of progress reports should be sent? • How will we assure that the goals were accomplished? • How will we maintain the progress made?


Sidebar 8-3.

Lean Management

Lean management is a method for advancing safety and quality that involves redesigning or designing processes to achieve reliability through standard work, mitigation, and continuous improvement. Typically, Lean focuses on speed, elimination of waste, standardization, and flexibility. It involves tapping into the wisdom and motivation of the frontline worker to continually learn and improve based upon providing value to the customer with the least amount of waste possible. A health care organization using Lean principles must first start with a high-level analysis of the process from the perspective of the population of the process—for example, the resident or staff member. The customer’s journey through the process is mapped step by step, from beginning to end. This sequence of process steps is called the value stream, and is recorded in the value stream map. The map is then analyzed, and the sequence of processes is segregated into process groups or “chunks,” that can then be improved through a series of “rapid improvement events” (RIEs). An RIE is a two- to four-day event in which a process or a component of a process is analyzed and improved through the work of an integrated team. The RIE serves the following purposes: • To improve and standardize a particular process, reduce waste, and improve reliability using Lean principles

implementation, data showed a 54% reduction in the number of patients not properly checked in for procedures and a 92% reduction of patients left unattended in the hallway.3 ■ After conducting an FMEA on its near-infrared analytical procedure for screening drugs, a Netherlands-based public health laboratory performed another risk analysis to measure the success of the redesigned processes. On recalculating the risk priority numbers, the team found that the six failure modes they addressed all saw risk reductions of 50% to 80%. 4 ■ Ashwini Kidney & Dialysis Centre, based in Nagpur, India, conducted an FMEA to review the hemodialysis process. When they recalculated the risk priority numbers four months after redesigning processes, the seven failure modes had reductions in risk of 50% to 90%. 5

• To grow the team’s knowledge of Lean methods and problem-solving skills through just-in-time training and the experience of the RIE • To effect cultural change over time, with multiple RIEs involving multiple members of the service line. Adherence to standard work and the skills for improvement become values and practices that are strengthened over time. A learning organization evolves. For example, a health care organization may want to improve its process for administering a high-risk medication. First, a team made up of individuals involved in the process would create a step-by-step map of the process and determine which elements warrant a closer review during an RIE. Then during the RIE, the components of the process under examination would be standardized and waste eliminated, making the resulting process leaner and more efficient. Lean management allows processes to be developed that are reliable, safe, and supportive of people in the health care environment. Waste is reduced, quality is built into the workflow, and efficiencies follow. Health care organizations that provide the leadership commitment to these methods are experiencing success by improving safety and supporting their staff in a learning environment.

■

■

Participants in a medication administration FMEA at Maine Medical Center reported that in addition to patient safety improvements, they also felt improved satisfaction with the decision-making process. They felt that they “owned” the decisions and were committed, as a group, to positive change. In addition, they became more aware of the way organization processes work together. 6 St. Louis Children’s Hospital conducted a FMEA to review the process for pediatric chemotherapy administration. After implementation of redesigned processes, the prescribing error rate was reduced from 23% to 14%, and use of preprinted standard order sets increased from 22% at the 2001 baseline, to 45% in 2003 (one year after the FMEA was conducted), and 76% in the 2005 followup. Dispensing and administration errors also decreased. 7

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Sidebar 8-4.

Robust Process

Improvement™

Robust Process Improvement™ (RPI) is The Joint Commission’s enterprise-wide systematic methodology for improving processes that seeks to continuously increase the quality and efficiency of products and services. The successful adoption of RPI techniques can produce substantial improvements in the quality of processes and products, as well as more consistent and effective customer service. RPI consists of a set of strategies, tools, methods, and training programs aimed at achieving the following: • Recognizing and seeking the voice of the customer • Defining factors critical to quality • Using data and data analysis to design improvement • Enlisting stakeholders and process owners in creating and sustaining solutions • Eliminating defects and waste • Drastically decreasing failure rates • Simplifying and increasing the speed of processes • Partnering with staff and leaders to seek, commit to, and accept change

Sustaining the Redesigned Process The final step for the FMEA team is to establish and implement a plan to monitor the improvement’s ongoing effectiveness. The goal is to maintain the redesigned process over time. Continuing education and reinforcement of new desired behaviors are key here. Organizations frequently falter when continued measurement indicates that improvement goals are not being sustained. More often than not, efforts tend to provide short-term rather than long-term improvement. How can an organization ensure that a redesigned process is maintained over time? Three activities performed by teams with leadership support are as follows: 1. Documentation. The team must thoroughly document the new process. This means providing both a graphic and nongraphic description of how the redesigned process operates. A new flowchart of the redesigned process is critical, as is a written description of the process steps and links between the steps. This might be appropriate in a

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procedures manual. Documentation provides a tool with which to educate staff about the process redesign. It also provides a tool that can be used in the future to explore the need for further process change. 2. Training, retraining, and competence assessment. With support provided by leaders, the team ensures that staff are trained and retrained as necessary about the process redesign, how to perform the steps of the new process, and links between the steps. Competence assessment must be regular and ongoing to ensure that staff maintain the skills necessary to maintain the redesigned process. The organization may want to consider using the FMEA itself as an internal training tool because it contains important knowledge about the safety of the high-risk process being redesigned. 3. Ongoing monitoring. The team must maintain vigilance about monitoring the redesigned process. This requires ongoing access to information about how the redesigned process is operating. It also requires regular feedback to everyone involved in the implementation of the new process. The lack of occurrence of a sentinel event or an adverse occurrence after a month or a year is not sufficient evidence of process redesign success. Remember, the reason for making changes in the first place was to reduce the likelihood of an infrequent adverse outcome. 8 Ongoing monitoring of the redesigned process can be integrated into the organization’s overall performance improvement program. The essential ingredient for the team’s success with each of these activities is leadership support. Leaders must provide the support needed to bring change in the form of process redesign directed at reducing harm to individuals. They must set the tone for a culture that supports safety and pursues a preventive approach to failure reduction. The culture must be a nonpunitive one. Designing or redesigning for safety means making it difficult for humans to err. However, leaders must recognize that failures will occur and that recovery or correction should be built into health care processes so that individuals can take corrective actions and thereby prevent harm. FMEA provides a systematic process for doing so. It focuses on the process of redesigning potentially problematic processes to prevent the occurrence of failures, to increase their detectability, or to mitigate the effect of a failure that does reach the individual being served. To achieve success with FMEA, leaders must provide their complete and unflagging support.

Chapter 8: Implementing and Monitoring the New Process References 1. Nelson E.C., Batalden P.B., Lazar J.S., eds.: Practice-based Learning and Improvement: A Clinical Improvement Action Guide, Second Edition. Oakbrook Terrace, IL: Joint Commission Resources, 2007. 2. Benchmarking and Safety: Natural fit if you know what to do with data. Healthcare Benchmarks Qual Improv 11:49–52, May 2004. 3. Abujudeh H.H., Kaewlai R.: Radiology failure mode and effects analysis: What is it? Radiology 252:544–550, Aug. 2009. 4. van Leeuwen J.F., et al.: Risk analysis by FMEA as an element of analytical validation. J Pharm Biomed Anal 50:1085–1087, 2009. 5. Ookalkar A.D., Joshi A.G., Ookalkar D.S.: Quality improvement in haemodialysis process using FMEA. Int J Qual Reliability Manag 26:817–830, 2009. 6. Riehle M.A., Bergeron D., Hyrkäs K.: FMEA and medication administration. Nurs Manag 28–33, Feb. 2009. 7. Robinson D.L., Heigham M., Clark J.: Using failure mode and effects analysis for safe administration of chemotherapy to hospitalized children with cancer. J Qual Pat Saf 32:161–166, Mar. 2006. 8. Croteau R.: Proactive risk reduction: How it works. Trustee pgs. 25–27, May 2003.

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140

Index

A

Abbreviations, 27 Action plan matrixes, 115 Affinity diagram, 51–53, 82–83, 85 Airline industry, 19 Amerikan Hastanesi (American Hospital) medication request process case study, 32, 58–59, 71–72, 92, 110–111, 121–122, 129–130 Analysis and testing of redesigned process, 119–125 data collection strategies, 123 documentation of outcomes of tests, 123 examples of, 118, 119, 120, 121–122, 123 paper testing, 120 pilot testing, 118, 122–123 Plan-Do-Study-Act (PDSA) cycle, 123–125 simulation, 120, 122 Anesthesia equipment, 106 Antibiotic therapy process, 33 Ashwini Kidney & Dialysis Centre hemodialysis process, 137 Assessment checklists, 104–105 Associations and organizations, professional, 32, 101, 134 B

Backup processes, 103–104, 119 Benchmarking, 134 Brainstorming process, 48, 50, 55, 82, 115, 120 Building design, FMEA use for, 28, 30 C

Canister gas processes, 114 Cascade of failures, 26–27 Case studies and examples Amerikan Hastanesi (American Hospital) medication request process, 32, 58–59, 71–72, 92, 110–111, 121–122, 129–130 Ashwini Kidney & Dialysis Centre hemodialysis process, 137 computerized medication systems design or redesign of to reduce errors, 102, 104, 105 fail-safe designs, 64 workarounds and potential failures, 54–55 diabetes screening process, 66, 87, 135, 137

Gaylord Hospital pressure ulcer prevention initiative, 29, 97, 106, 120, 132 Health Care for the Homeless psychosocial assessment completion process, 49, 67–68, 77, 109, 123, 128 interventional pulmonology program FMEA example, 65 Maine Medical Center medication administration process, 137 Massachusetts General Hospital diabetes screening process, 135, 137 Miami Valley Hospital neonatal intensive care unit laboratory test ordering process, 26, 43–44, 73, 90–91, 105, 118, 134 Netherlands-based laboratory near-infrared analytical procedure, 137 St. Louis Children's Hospital pediatric chemotherapy administration process, 137–138 University of Texas M.D. Anderson Cancer Center opioid prescribing process, 35, 51–52, 63, 83, 107, 119, 131 Cause-and-effect (fishbone) diagrams, 83, 86–87, 115, 123 Change analysis, 83, 85, 88 Change and performance improvement, structures to manage (LD.03.05.01), 11 Chemotherapy administration process, 137–138 Clients. See Patients, clients, and customers Clinical practice guidelines and clinical pathways, 5, 103, 104, 134–135 Communication of changed process, 118–119, 127 documentation as, 106–107 hierarchical cultures and, 28 processes related to, root cause analysis of, 78, 79, 81 safety and quality of care, communication of information related to (LD.03.04.01), 10–11 with staff International Patient Safety Goals, 4 quality improvement and patient safety program, 4 safety and quality of care information, 10–11 standardization of, 103 team-based approach to care and, 22 verbal orders histogram examples, 94 read-back of, 103 Computerized medication systems

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Toolkit for Preventing Health Care–Associated Infections

design or redesign of processes, 102, 104, 105, 106–107, 109 fail-safe designs, 64 workarounds and potential failures, 54–55 Concentrated potassium, 106 Constraints (forcing functions), 106 Control charts, 85, 88, 89, 123, 134 Critical pathways and clinical practice guidelines, 5, 19, 103, 104, 134–135 CRM (Crew Resource Management) program, 19 Culture of safety, 1, 138 Customers. See Patients, clients, and customers

flowcharts (see Flowcharts [process maps]) process for, 41 walking through the process, 46–47 Dialysis process, 137 DMAIC (Define, Measure, Analyze, Improve, Control), 136 Documentation of analysis and testing of redesigned process, 123 communication through, 106–107 of new process, 138 Drug dosages, abbreviations for, 27 E

D

Data collection and analysis. See also Performance measurement data analysis requirement (PI.02.01.01), 16–17 benchmarking, 134 collection requirement (PI.01.01.01), 13–16 comparisons made during analysis (QPS.4.2), 7 criteria for, 82 data and information to guide decisions (LD.03.02.01), 10 external comparisons, 134 FMEA and, 24 frequency of analysis (QPS.4.1), 7 during implementation of redesigned process, 128–129, 133–135 individual responsible for (QPS.4), 7 internal comparisons, 134 measures choosing what to measure, 82 definition of, 80 outcome measures, 117, 123, 128–129 process measures, 123, 128–129 performance improvement data, 30 strategies for, 123 tools and techniques for (QPS.4), 7 trends and variations, analysis of (QPS.7), 8 Data validation independent third-party validation process (QPS.5.1), 8 internal process for (QPS.5), 7–8 Decision-tree analysis, 66 Define, Measure, Analyze, Improve, Control (DMAIC), 136 Diabetes screening cause-and-effect (fishbone) diagram of, 87 hazard analysis and decision-tree analysis, 66 Massachusetts General Hospital diabetes screening process, 135, 137 Diagramming a process common mistakes, 45–46 complexity of process and, 33 differences between intended and actual process, identification of, 42, 50 event lines, 45 examples of, 43, 46, 47, 49, 51–52, 58

142

Electrical power supply, 103 Electronic medical records, 104 Environmental management environmental factors, failures related to, 77 processes related to, root cause analysis of, 78, 79, 81 Equipment fail-safe designs, 105–106 failures related to, 77 new equipment, FMEA of, 28 processes related to, root cause analysis of, 78, 79 Event lines, 45 Event-tree (fault-tree) analysis, 23, 88, 92–93 F

Facility design, FMEA use for, 28, 30 Fail-safe designs, 64, 105–106 Failure mode and effects analysis (FMEA) barriers to effective use of, 23, 24, 36 basis for, 19 benefits of, 3, 19, 20, 22 definition of key words, 1 effectiveness of, 2, 3, 19 goal of, 20 leadership responsibilities during, 28 leadership support for, 22–23, 138–139 limitations of, 22–23 pitfalls to, 23, 24 process for, 2–3, 19–20, 21 ( see also specific steps in process) purpose of, 1–2, 19 RCA compared to, 20 scope of, 33, 36–39 skepticism about, 1–2 success of, 23–24 system and process design and, 20, 22 team for (see Team for FMEA) time and labor needed for, 23, 33 use of during RCA, 20 worksheet to track progress, 56–57 Failure modes active failures, 50 categorizing ideas, 50–53, 82–83

Index

consensus of team members on ratings, 69–70 criticality of consensus of team members on ratings, 69–70 determination of, 61–62 definition of, 47 detectability of, 63–65, 69, 102 effects of, 53, 55, 64, 114 identification of, 47–48 brainstorming process, 48, 50 examples of, 44, 59 resources for, 50 risk points, identification of, 50 interrelationships of, 23 latent conditions and failures, 27, 50, 76 low-frequency, high-severity failures, 28 multiple failures, 23 prioritization of, 23, 61, 69, 70–73 examples of, 63, 67–68, 71–73 rating scales, 65 risk priority number (RPN), 69, 70, 73, 120 probability of occurrence, 62–63, 64, 65, 66, 67–68, 69 probability of occurrence, reduction of, 102 proximate causes, 76–78 rating methods, 65, 69 rating scales, 65 RCA approach to, 75–76 in redesigned process, 114 risk priority number (RPN), 69, 70, 73, 120 severity of determination of, 62–63 examples of analysis, 66, 67–68 reduction of, 102 severity scoring scale, 62, 64 timing of failure during process and injury to individual receiving care, 53 variation and, 75–76 common-cause variation, 75–76, 78, 88 introduction of through process redesign process, 119–120 reduction of, 88 special-cause variation, 76, 78, 88 workarounds and potential failures, 54–55, 105 Fault-tree (event-tree) analysis, 23, 88, 92–93 Fetal heart rate monitoring, 103 Financial impact of risks, 32, 80 Financial performance, 22 Fishbone (cause-and-effect) diagrams, 83, 86–87, 115, 123 Flowcharts (process maps) analysis and testing of redesigned process, 120 diagramming the process with, 42, 45 documentation of outcomes of tests, 123 event lines, 45 examples of, 43, 46, 47, 49, 51–52, 58 of new process, 138

steps for creating, 45 symbols for, 42, 45 Forcing functions (constraints), 106 G

Gantt charts, 115, 133 Gaylord Hospital pressure ulcer prevention initiative case study, 29, 97, 106, 120, 132 Generator, emergency, 103 H

Health Care for the Homeless psychosocial assessment completion process case study, 49, 67–68, 77, 109, 123, 128 Hierarchical cultures, 28 High-risk process characteristics of, 25–28 risk-reduction strategies, 109, 112, 113 selection of for FMEA investigation, 23, 25, 32–33 case studies, 26, 29, 32, 35 external sources to identify process to analyze, 30, 32 internal sources to identify process to analyze, 30 standardization of, 102–103 Histograms, 94, 123, 134 Human-factor variation, 1, 27, 77 Human resources processes, 78, 79, 81 I

Implementation of redesigned process actions to lead change process, 127–128 activities for, 128 barriers to implementation, 112, 114, 128 change process, strategies to manage, 128 communication of changed process, 118–119, 127 data collection and analysis during, 128–129, 133–135 documentation of new process, 138 examples of, 128, 129–132, 134 how to implement, 117–118 long-term and short-term plans, 114 measurement and monitoring during, 128–129, 133 measurement and monitoring of redesigned process, 138–139 modifications to redesigned process, 135 organizing prior to, 117–119 performance targets, specifications, and thresholds, 135 Plan-Do-Study-Act (PDSA) cycle, 123–125 resources for, 128 shortcuts and workarounds, 109 sustaining redesigned process, 138–139 time frame for, 128 when to implement, 118 where will it be implemented, 118 who is responsible for implementation, 118 Infant abduction, risk-reduction strategies, 113

143


Information management FMEA and, 24 processes related to, root cause analysis of, 78, 79, 81 Infusion pumps, 105–106 International Patient Safety Goals communication with staff about (QPS.1.4), 4 implementation of (QPS.1.2), 4 key measures identification for (QPS.3.3), 7 International Society for Quality in Health Care (ISQua), 2 Interventional pulmonology program FMEA example, 65 Interviews and surveys, 30, 80, 82, 108–109, 123 ISQua (International Society for Quality in Health Care), 2 IV infusion pumps, 105–106 J

Joint Commission Leadership (LD) standards and requirements, 1, 2, 10–13 Performance Improvement (PI) standards and requirements, 1, 13–18 purpose of standards and evaluation methods, 2 Robust Process Improvement (RPI), 135, 138 Sentinel Event Alerts, 30, 32 Sentinel Event Database, 30, 31 Joint Commission International accreditation and certification standards, 2 ISQua accreditation, 2 purpose of, 2 Quality Improvement and Patient Safety (QPS) standards and requirements, 1, 3–9 Sentinel Event Policy, 30, 33 L

Laboratory near-infrared analytical procedure, 137 Laboratory reports affinity diagram, 85 Laboratory test ordering process case study, 26, 43–44, 73, 90–91, 105, 118, 134 Latent conditions and failures, 27, 50, 76 Laws and regulations compliance (LD.04.4.01), 12–13 Leadership error reduction, responsibility for, 1 incidents, response to, 30 quality improvement and patient safety program, responsibility for (QPS.1), 3 resources for FMEA, 22–23, 36 responsibilities of during FMEA, 28 support for FMEA, 22–23, 138–139 team for FMEA, influence of leadership on development of, 36 Leadership (LD) standards and requirements, 1, 10–13, 20 change and performance improvement, structures to manage (LD.03.05.01), 11 data and information to guide decisions (LD.03.02.01), 10 laws and regulations compliance (LD.04.4.01), 12–13 safety and quality of care

144

communication of information related to (LD.03.04.01), 10–11 focus of individuals who work in organization on (LD.03.06.01), 11–12 planning activities to support (LD.03.03.01), 10 Leadership processes, 78, 79, 81 Lean Management, 137 Liability insurance companies, 32 Loosely coupled processes, 27, 64 Low-frequency, high-severity errors and failures, 28 Low-risk processes, 28 M

Maine Medical Center medication administration process, 137 Managerial structures, processes, and outcomes, key measures identification for (QPS.3.2), 6 Massachusetts General Hospital diabetes screening process, 135, 137 Measures. See Performance measurement data Medical errors and mistakes active failures, 50 cascade of failures, 26–27 causes of, 1 FMEA and, 23 human failure, 1, 27, 77 latent conditions and failures, 27, 50, 76 leadership response to, 30 near-miss events, identification and analysis of (QPS.8), 8 reduction of continuous process assessment and, 1 culture of safety and, 1 FMEA use for, 1–2, 19, 22 leadership's responsibility for, 1 performance improvement efforts and, 1 staff education and training and, 27, 108 reporting systems, 30 response to, 1, 108 Swiss cheese model of error occurrence, 27 Medical records, electronic, 104 Medication processes case studies and examples Amerikan Hastanesi (American Hospital) medication request process, 32, 58–59, 71–72, 92, 110–111, 121–122, 129–130 Maine Medical Center medication administration process, 137 outpatient parenteral antibiotic therapy service, 33 St. Louis Children's Hospital pediatric chemotherapy administration process, 137–138 complexity of, 33 computerized medication systems design or redesign of processes, 102, 104, 105, 106–107, 109 fail-safe designs, 64

Index

workarounds and potential failures, 54–55 drug dosages, abbreviations for, 27 failure mode effects during, 53, 55 FMEA team example, 34 hierarchical cultures and, 28 medication utilization process, design of, 22 reconciliation process flowchart, 47 risk-reduction strategies, 112 Miami Valley Hospital neonatal intensive care unit laboratory test ordering process case study, 26, 43–44, 73, 90–91, 105, 118, 134 Multivoting, 94–95, 115 N

Near-miss events, identification and analysis of (QPS.8), 8 Netherlands-based laboratory near-infrared analytical procedure, 137 O

Online Extras, 3 Opioid prescribing process case study, 35, 51–52, 63, 83, 107, 119, 131 Organizational culture barriers to effective use of FMEA, 23, 24, 36 culture of safety, 1, 138 hierarchical cultures, 28 processes related to, root cause analysis of, 78, 79, 81 Organizations and associations, professional, 32, 101, 134 Outcome measures, 117, 123, 128–129 Outpatient parenteral antibiotic therapy service, 33 Oxygen canister processes, 114 P

Pain medication management, 22 Paper testing, 120 Parenteral antibiotic therapy service, 33 Pareto charts, 30, 70, 73, 95–97, 115, 123 Patients, clients, and customers assessment checklists, 104–105 feedback from, 30, 80, 82 timing of failure during process and injury to individual receiving care, 53 PDCA (Plan-Do-Check-Act) cycle, 123 PDSA (Plan-Do-Study-Act) cycle, 123–125 Pediatric chemotherapy administration process, 137–138 Performance and quality improvement tools data analysis with, 134 documentation of outcomes of tests, 123 familiarity of of team members with, 36 interrelationships of failure modes, understanding of through use of, 23 Plan-Do-Study-Act (PDSA) cycle, 123–125 prioritization of failure modes with, 70, 73 for RCA process, 82–99

redesigning a process, evaluation of redesign elements, 115 selection of process for FMEA investigation through use of, 30 Performance improvement. See also Performance Improvement (PI) standards and requirements achievement and sustainment of, 8, 23–24 change and performance improvement, structures to manage (LD.03.05.01), 11 error reduction through, 1 FMEA as tool for, 20, 22 teamwork initiatives, 109 timeliness of care and safety, 22 Performance Improvement (PI) standards and requirements, 1, 13–18, 20 data collection and analysis analysis requirement (PI.02.01.01), 16–17 collection requirement (PI.01.01.01), 13–16 improvement opportunities and activities (PI.03.01.01), 17–18 Performance improvement data, 30 Performance measurement data benchmarking, 134 choosing what to measure, 82 clinical practice guidelines and clinical pathways, 134–135 external comparisons, 134 implementation of redesigned process, 128–129, 133 internal comparisons, 134 measure choosing what to measure, 82 definition of, 80 measure, definition of, 80 outcome measures, 117, 123, 128–129 process measures, 123, 128–129 qualitative measures, 117–118 quantitative measures, 117–118 as RCA resource, 80, 82 Pilot testing, 118, 122–123 Plan-Do-Check-Act (PDCA) cycle, 123 Plan-Do-Study-Act (PDSA) cycle, 123–125 Potassium concentrations, 106 Practice guidelines and clinical pathways, 5, 103, 104, 134–135 Preoperative procedures, risk points during, 50 Pressure ulcer prevention initiative case study, 29, 97, 106, 120, 132 Proactive risk assessment design of, 2–3 financial savings through, 22 FMEA as tool for, 22 leadership support for, 1 requirement for, 2 standards related to, 10–18, 20 Proactive risk reduction, 70 Processes and systems. See also High-risk process analysis and testing of redesigned process (see Analysis and testing of redesigned process) analysis of after sentinel event, 20

145


change and performance improvement, structures to manage (LD.03.05.01), 11 clinical structures, processes, and outcomes, key measures identification for (QPS.3.1), 5–6 complexity of, 1, 26, 33, 103, 119 continuous process assessment, 1 design of according to quality improvement principles, 4–5 fail-safe designs, 64, 105–106 FMEA and, 20, 22 premise that nothing will go wrong, 1 risk assessment or redesigned processes, 28 time needed for, 23 diagramming of (see Diagramming a process) differences between intended and actual process, identification of, 42, 50 financial impact of risks, 32, 80 hand offs during, 27 human-factor variation, 1, 27, 77 implementation of redesigned process (see Implementation of redesigned process) input/output mismatch, 119 latent conditions and failures, 27, 50, 76 loosely coupled processes, 27, 64 loose time constraints, 28 managerial structures, processes, and outcomes, key measures identification for (QPS.3.2), 6 redesigning a process documentation of new process, 138 effects of elements of redesigned process, 114 evaluation of redesign elements, 109, 112, 115 examples of, 105, 106, 107, 109, 110–111 failure modes in redesigned process, 114 impact of redesigned elements, 114 importance of, 101 methodical approach to, 109 methods for, 102–109 modifications to redesigned process, 135 preparations for, 101–102 resources for, 101 strategies for, 102 sustaining redesigned process, 138–139 redundancy, 103–104, 119 risk points, 50 selection of for FMEA investigation, 23, 25, 28, 32–33 case studies, 26, 29, 32, 35 external sources to identify process to analyze, 30, 32 internal sources to identify process to analyze, 30 shortcuts and workarounds, 54–55, 103, 105, 109 simplification of, 103, 119 standardization of, 26, 102–103 tightly coupled processes, 26–27, 28, 64, 107–108, 119 tight time constraints, 27–28

146

timing of failure during process and injury to individual receiving care, 53 variable input, 26 variation in common-cause variation, 75–76, 78, 88 introduction of through process redesign process, 119–120 reduction of, 88 special-cause variation, 76, 78, 88 walking through the process, 46–47 Process maps. See Flowcharts (process maps) Process measures, 123, 128–129 Professional associations and organizations, 32, 101, 134 Proximate causes, 76–78 Psychosocial assessment completion process case study, 49, 67–68, 77, 109, 123, 128 Q

Quality Improvement and Patient Safety (QPS) standards and requirements, 1, 3–9, 20 clinical practice guidelines and clinical pathways, use of (QPS.2.1), 5 clinical structures, processes, and outcomes, key measures identification for (QPS.3.1), 5–6 data collection and analysis comparisons made during analysis (QPS.4.2), 7 data and information to guide decisions (LD.03.02.01), 10 frequency of analysis (QPS.4.1), 7 individual responsible for (QPS.4), 7 tools and techniques for (QPS.4), 7 trends and variations, analysis of (QPS.7), 8 data validation independent third-party validation process (QPS.5.1), 8 internal process for (QPS.5), 7–8 improvement and safety activities, priority areas for (QPS.10), 9 improvement in quality and safety, achievement and sustainment of (QPS.9), 8 International Patient Safety Goals communication with staff about (QPS.1.4), 4 implementation of (QPS.1.2), 4 key measures identification for (QPS.3.3), 7 managerial structures, processes, and outcomes, key measures identification for (QPS.3.2), 6 measurement activities, priorities for (QPS.1.2), 4 near-miss events, identification and analysis of (QPS.8), 8 quality improvement and patient safety program collaborative approach to (QPS.1.1), 3 communication with staff about (QPS.1.4), 4 keys measures, identification of (QPS.3 through QPS.3.3), 5–7 leadership responsibility for (QPS.1), 3 priorities for (QPS.1.2), 4 staff education and training on role in (QPS.1.5), 4 systematic approach to (QPS.1.1), 3

Index

technological and other support for (QPS.1.3), 4 risk management program (QPS.11), 9 systems and processes, design of (QPS.2), 4–5 Quality improvement tools. See Performance and quality improvement tools R

Radiation administration fault-tree analysis diagram, 93 treatment planning process flowchart, 46 Rapid improvement events (RIEs), 137 Rating scales, 65 RCA. See Root cause analysis (RCA) Redundancy, 103–104, 119 Regulations and laws compliance (LD.04.04.01), 12–13 Reporting systems, 30 Restraint use performance measurement data on, 80, 82 process team example, 34 risk-reduction strategies, 113 run chart example, 98 Resuscitation, 34, 102 RIEs (rapid improvement events), 137 Risk management financial impact of risks, 32, 80 proactive risk assessment design of, 2–3 financial savings through, 22 FMEA as tool for, 22 leadership support for, 1 requirement for, 2 standards related to, 10–18, 20 proactive risk reduction, 70 program for (QPS.11), 9 risk-reduction strategies, 109, 112, 113 Risk points, identification of, 50 Risk priority number (RPN), 69, 70, 73, 120 Robust Process Improvement (RPI), 135, 138 Root cause analysis (RCA) common-cause variation, 75–76, 78, 88 criteria for use and truncation of, 99 effective RCA, characteristics of, 76 FMEA compared to, 20 focus of, 75 process for, 75 probing for root causes, 78, 99 questioning process, 76–80, 99 proximate causes, 76–78 requirement for, 20 resources for, 70, 80, 82 root causes characteristics of, 80 examples of identification of, 77, 83, 90–92, 97

failure because of, 75 identification of all, 76–80, 81 number to identify, 80 probing for, 78, 99 sentinel events and, 75, 76 special-cause variation, 76, 78, 88 time needed for, 70 tools to help with, 82–99 use of during FMEA, 20, 70, 75–76 RPI (Robust Process Improvement), 135, 138 RPN (risk priority number), 69, 70, 73, 120 Run charts, 97–98, 134 S

Safety and quality of care communication of information related to (LD.03.04.01), 10–11 data and information to guide decisions about (LD.03.02.01), 10 focus of individuals who work in organization on (LD.03.06.01), 11–12 planning activities to support (LD.03.03.01), 10 team-based quality improvement, 22–23 timeliness of care and, 22 Safety improvement tools. See Performance and quality improvement tools St. Louis Children's Hospital pediatric chemotherapy administration process, 137–138 Scatter diagrams, 98–99, 123 Sentinel Event Alerts (Joint Commission), 30, 32 Sentinel Event Database (Joint Commission), 30, 31 Sentinel Event Policy (Joint Commission International), 30, 33 Sentinel events definition of, 1 information about, 30–32 root cause analysis (RCA) and, 75, 76 selection of process for FMEA investigation and, 30 statistics on, 30, 31 suicide cause-and-effect (fishbone) diagram of contributing factors, 86 proximate causes of, 77 risk-reduction strategies, 113 systems and processes, analysis of after sentinel event, 20 types of organizations that can experience, 30 wrong-site surgery investigation Pareto chart example, 96 Services, new, 28 Shortcuts and workarounds, 54–55, 103, 105, 109 Simulation, 120, 122 Six Sigma, 135, 136 Staff communication with International Patient Safety Goals, 4 quality improvement and patient safety program, 4

147

JCI FMEA-2010

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