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Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction, Third Edition
Failure Mode and Effects Analysis
in Health Care: Proactive Risk Reduction, Failure Mode and Effects
Third Edition Analysis in Health Care:
Health care professionals around the world can use a proactive technique to reduce the risk of harm to individuals
receiving care, treatment, and services. Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction, Third
Edition illustrates the FMEA method to identify and manage potential risks to individuals in all health care settings. Proactive Risk Reduction
Your organization can adopt this proactive model to identify impending risks and develop strategies to mitigate risks and
find solutions to errors. This book includes the following:
A logical, step-by-step guide through the FMEA process
Processes that can be redesigned and used by health care organizations worldwide
How to prioritize critical factors of effects based on frequency or rarity
How to conduct an analysis of functions, failure modes, effects, and causes in relationship to contributor factors
How to implement and sustain continuous improvement
Online Extras for Failure Mode and Effects Analysis: Proactive Risk Reduction, Third Edition are
available on Joint Commission Resources Web site at http://www.jcrinc.com/FMEA10/extras.
The Online Extras consist of real-world examples from organizations around the world using
FMEA for risk reduction, in addition to links that illustrate examples of how to use some of the
steps involved with FMEA.
About Joint Commission Resources

JCR is an expert resource for health care organizations, providing consulting services, educational services, and publica-
tions to assist in improving quality and safety and to help in meeting the accreditation standards of the Joint
Commission. JCR provides consulting services independently from the Joint Commission and in a fully confidential
manner. Please visit our web site at http://www.jcrinc.com.
About Joint Commission International

Joint Commission International (JCI) is a client-focused, results oriented, premier source of knowledge for health care
organizations, government agencies, and third party payers throughout the world. It provides educational services, con-
sulting services, and publications to assist in improving the quality, safety, and efficiency of health care services. JCI
offers international and country specific accreditation programs and other assessment tools to provide objective evalua-
tions of the quality and safety of health care organizations.
Third
Edition
FMEA10
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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
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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
iii
Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction
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
iv
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
v
vi
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
are increasingly interdependent and are often interlocked or
tightly coupled. Inconsistency, variable input, tight time con-
straints, a hierarchical culture, and the dependence on human
reasonable expectation. Therefore, if health care professionals intervention increase the risk of failure in system processes
just pay attention and work hard, nothing will go wrong. throughout an organization.
Education and training efforts, more extensive in health care Failure mode and effects analysis (FMEA) is one technique for
than in most other fields, focus on teaching health care profes- systems improvement that can enhance safety. FMEA is a
sionals to do the right thing. The assumption is that proper team-based, systematic, proactive, and reasoned-based tech-
education and training will help health care professionals to not nique that is used to prevent process and product problems
make mistakes. Hence, processes in health care organizations before they occur. It provides a look not only at what problems
have historically been designed based on the premise that noth- could occur but also at how severe the effects of the problems
ing will go wrong. When things do go wrong, the individuals could be. FMEA assumes that no matter how knowledgeable or
involved are retrained, punished, or sanctioned. This widely careful people are, failures will occur in some situations and could
held view, however, is seriously flawed. even be likely to occur. The focus is on what could allow the fail-
ure to occur. Ideally, FMEA can be used to help prevent fail-
Improvement in performance, continuous process assessment, ures from occurring. However, if a particular failure cannot be
and a strong culture of safety are key to reduced errors in health prevented, FMEA then focuses on protections that can be put
care. Leaders have a direct responsibility; they are, in effect, in place to prevent the failure from reaching the individual
responsible for the care, treatment, and services that the organ- receiving care, treatment, or services, or, in the worst case, mit-
ization provides to its population. Leaders administer the oper- igate its effects if the failure can cause harm.
ations of a health care organization and direct it on a day-to-day
basis. They keep operations running efficiently so that the Those who are accustomed to an evidence-based approach to
important work of the organization can continue. Therefore, safety may view FMEA with some skepticism, more as a spec-
undertaking a proactive risk assessment must be supported and
led by leadership as defined in Joint Commission Internation-
als Quality Improvement and Patient Safety chapter (see Side- Defining FMEA Key Words
bar A-1, pages 39) and The Joint Commissions Leadership Failure: When a system or part of a system performs
and Improving Performance chapters (see Table A-2, pages in a way that is not intended or desirable.
1018). Mode: The way or manner in which something, such
as a failure, can happen. Failure mode is the manner in
What Is Failure Mode and Effects which something can fail.
Analysis? Effects: The results or consequences of a failure mode.
Health care is an exceedingly complicated system where acci- Analysis: The detailed examination of the elements or
dents, errors, close calls (also known as near misses), sentinel structure of a process.
events*, failures, and adverse events happen. In addition, health
care processes exist throughout health care organizations that
* 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.
1
ulative method than a scientific one. Even incident reporting Joint Commission International accreditation and certification
isnt 100% scientific. FMEA is a ready-made prospective standards, measurable elements, and evaluation methods are
process that has a good track record and a number of benefits. designed to do the following:
It is proactive instead of retrospective. It addresses problems Stimulate and support sustained quality improvement
that people have actually seen happen or errors they have Provide a framework for risk reduction
almost made before it reaches the person receiving care. It is Provide a focus on creating a culture of safety
excellent, then, for capturing incidents that can and do occur
and that generally are not captured any other way. Also, the Developed by health care experts from around the world and
multidisciplinary process pulls several kinds of information tested in every world region, these standards were created by
together (root causes as well as potential effects) and allows staff health care professionals specifically for the health care sector
to target responses in new ways. and applicable to individual health care organizations and
national health care systems.
FMEA can improve the safety for individuals receiving care by
helping to identify failures and close calls and by protecting The Joint Commission Standards
individuals from harm or mitigating harm when, despite an Since 1951, The Joint Commission has offered and maintained
organizations best efforts, failures do occur. It can narrow or state-of-the-art accreditation programs for health care organiza-
eliminate gaps in quality and performance and yield improved tions in the United States. Accreditation today provides organ-
outcomes. It is easy to learn and enhances organizationwide izations with standards, performance improvement tools, and
collaboration and understanding. In short, its use is good busi- an external evaluation of performance. An independent, not-
ness practice. As with any other tool, the more you use FMEA, for-profit organization, The Joint Commission accredits and
the more familiar and comfortable it becomes. certifies more than 17,000 health care organizations and pro-
grams in the United States. Joint Commission accreditation
Purpose of This Book and certification is recognized nationwide as a symbol of qual-
Joint Commission International and The Joint Commission ity that reflects an organizations commitment to meeting cer-
require accredited health care organizations to conduct proac- tain performance standards.
tive risk assessments. The purpose of this book is to provide
health care leaders and staff from around the world with a step- The Joint Commissions standards, rationales, elements of per-
by-step guide to conducting FMEA if it is chosen by your formance, and evaluation method are designed to do the fol-
organization as its proactive risk assessment method. Each lowing:
chapter addresses a different step of the FMEA process. Address the organizations level of performance in key
functional areas, such as care, treatment, and services, med-
This book also offers case studies provided by several organiza- ication safety, and infection prevention and control
tions that have conducted FMEA projects resulting in signifi- Set expectations for an organizations actual performance
cant improvements. As you read through each step in the and for assessing its ability to provide safe, high quality care
FMEA process, you will see how each of these organizations Set forth performance expectations for activities that affect
addressed each step. the safety and quality of care
Joint Commission International How to Use This Book

Standards Throughout this book, FMEA refers to the basic steps in a
As the international arm of The Joint Commission, Joint generic FMEA. Other proactive risk-reduction processes that
Commission International has been working with health care encompass these basic steps may also be used.
organizations, ministries of health, and organizations in more
than 80 countries since 1994. In September 2007, Joint This book provides a place to start and an approach for consid-
Commission International received accreditation by the eration of FMEA. The key task is for each reader to use the
International Society for Quality in Health Care (ISQua). process described here to proactively design or redesign poten-
Accreditation by ISQua provides assurance that the standards, tially problematic health care processes in order to reduce the
training, and processes used by Joint Commission International risk of harm.
to survey the performance of health care organizations meet the
highest international benchmarks for accreditation entities.
2
About This Book
Much variation exists in how health care organizations have mitigation weapons for most high-risk processes in health care.
conducted FMEA to date and how they define the key steps The benefits of FMEA in preventing sentinel events that cause
and terms of a FMEA approach. Health care leaders and staff harm to individuals far outweigh its costs.
around the world can use this book to familiarize themselves
with the concept of FMEA and then creatively design a proac- Acknowledgments
tive risk assessment and reduction process that is most likely to A special thank you is extended to the following organizations
meet the organization-specific needs. More than a few hours or that contributed FMEA processes to this book:
a couple of days are needed to learn to use and conduct a Amerikan Hastanesi, Istanbul, Turkey
FMEA, although the process is not difficult. Advice from Gaylord Hospital, Wallingford, CT
organizations that have conducted a FMEA can speed the Health Care for the Homeless, Inc., Baltimore, MD
process along. The tools and examples provided in this book Miami Valley Hospital, Dayton, OH
can be easily adapted for use in a FMEA process. University of Texas M.D. Anderson Cancer Center,
Houston, TX
In addition, Tip boxes are provided throughout the book
that may be used as a quick point of reference when conduct- We also thank Joint Commission International, The Joint
ing a FMEA. Online Extras are also available on Joint Commission, and Joint Commission Resources reviewers
Commission Resources Web site at http://www.jcrinc.com/ Gerard Castro, Anita Giuntoli, Linda Slepicka, Cherie
FMEA10/extras. When this symbol is found with an Ulaskas, Francine Westergaard, and Paul Reis. In addition,
example, the example can also be found on the Web site. thank you to writer Julie Chyna for updating this important
book.
FMEA is a powerful toolat 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 organizations leadership participates in developing the plan for the quality improvement and patient safety
program.
2. The organizations leadership participates in measuring the quality improvement and patient safety program.
3. The organizations leadership establishes the oversight process or mechanism for the organizations quality
improvement and patient safety program.
4. The organizations leadership reports on the quality and patient safety program to governance.
Standard QPS.1.1 The organizations leaders collaborate to carry out the quality improvement and patient safety
program.
Measureable Elements
1. The organizations 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 organizations quality measuremenr and
control activities.
5. The program employs a systematic approach to quality improvement and patient safety.
(continued)
3
Table A-1. continued

Joint Commission International Standards and Requirements
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 measure-
ment results.
2. The leaders provide technology and support, consistent with the organizations resources, for tracking and com-
paring 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 improve-
ment 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 organizations 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
4
About This Book

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, clin-
ical 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 organizations leaders identify key measures in the organizations struc-
tures, processes, and outcomes to be used in the organizationwide quality improvement and patient safety plan.
Measurable Elements
1. The organizations 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 organiza-
tional leaders and the governance structure of the organization.
Standard QPS.3.1 The organizations leaders identify key measures for each of the organizations clinical struc-
tures, processes, and outcomes.
(continued)
5

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 organizations leaders identify key measures for each of the organizations managerial struc-
tures, 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.
6
About This Book

Standard QPS.3.3 The organizations 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 ana-
lyze 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 organiza-
tion 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)
7

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 patients illness or underlying condition (for
example, suicide)
b) Major permanent loss of function unrelated to the patients 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 hospitals
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)
8
About This Book

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 orga-
nizations leaders.
Measurable Elements
1. The priority areas identified by the organizations 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 organizations 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 organizations 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.
9
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 varia-
tion 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 informa-
tion 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.
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.
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.
10
About This Book

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, individu-
als 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 organ-
ization.
1. Structures for managing change and performance improvements exist that foster the safety of the patient, resi-
dent, or individual served, and the quality of care, treatment, and services.
2. Leaders are able to describe how the organizations 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 suffi-
cient staff, access to information, and training.
5. The management of change and performance improvement supports both safety and quality throughout the
organization.
6. The organizations 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.
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)
11

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.

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 regula-
tions, 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 accredi-
tation, certification, or regulatory bodies.
12
About This Book

Applicable to the ambulatory care program:

15. For ambulatory surgical centers that elect to use The Joint Commission deemed status option: The organiza-
tion 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 inpa-
tient 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 psychi-
atric distinct part unit(s) beds are physically separate from the critical access hospitals 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 hospitals 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.
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

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 pro-
grams:
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 hospitals 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
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

19. The impact of the organizations 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, com-
pleteness 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.
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.
tion, with the participation of the medical staff, collects data on the medical necessity of procedures.
tion, 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, labora-
tory, 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
31. For foster care: The agency collects data on its performance, including the safety of the placement and the
maintenance or improvement of the individuals level of functioning.
32. For foster care: The agency collects data on the permanency of the placement and the permanency of out-
come when they are within the organizations scope of services.
(continued)
15


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.
The hospice collects data on adverse patient events.
35. For DMEPOS suppliers serving Medicare beneficiaries: The organization seeks input from employees, benefi-
ciaries, and referral sources when assessing the quality of its operations and services.
36. For ambulatory surgery centers that elect to use The Joint Commission deemed status option: The ambula-
tory 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 projects 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 num-
ber and severity of fall-related injuries.
39. The hospital collects data on the effectiveness of its response to change or deterioration in a patients condi-
tion. Note: Measures may include length of stay, response time for responding to changes in vital signs, car-
diopulmonary arrest, respiratory arrest, and mortality rates before and after implementation of an early inter-
vention plan.
Standard PI.02.01.01 The organization compiles and analyzes data.

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

Applicable to the behavioral health care and laboratory program: Note: Examples of external sources of infor-
mation 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 organi-
zation (OPO). Note: Conversion rate is defined as the number of actual organ donors over the number of eligi-
ble donors defined by the OPO, expressed as a percentage.
8. The hospital uses the results of data analysis to identify improvement opportunities.
The hospice uses the data collected to monitor the effectiveness and safety of services and the quality of care.
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 ambula-
tory surgical centers services and operations.
Standard PI.03.01.01 The organization improves performance on an ongoing basis.

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.
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 hospices services.
9. For hospices that elect to use The Joint Commission deemed status option: The hospice documents what per-
formance improvement projects are being conducted, the reasons for conducting these projects, and the meas-
urable progress achieved on them.
17


10. For ambulatory surgical centers that elect to use The Joint Commission deemed status option: The ambula-
tory 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.
18
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 profes-
Step 1
Select a high-risk process and
sionals can learn with ease. Offering an extremely powerful approach assemble a team.
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
Step 2
intolerable, then examining and redesigning processes to prevent
Diagram the process.
and/or mitigate the effects of those mistakes. FMEA has been around
for decades because it works.
A Step-by-Step Approach to FMEA Step 3

In brief, FMEA is performed as follows: The responsible team identi- Brainstorm potential failure modes
fies each step in a process or subprocess and the relationships between and determine their effects.
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 Step 4
examines the interrelationship between the process being studied and Prioritize failure modes.
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 min- Step 5
imize the consequences of an error. Then the team reviews and re- Identify root causes of failure
vises, as necessary, the action or actions being taken or implemented to
modes.
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 Step 6
human factors analysis, formal systems analysis, and team training. Redesign the process.
The goal is to achieve optimal performance and proactively eliminate
errors. Such approaches have also been useful and successful in a num-
ber of industriesfor example, the airline industrys development of a
Crew Resource Management (CRM) program. CRM has been used
Step 7
throughout the airline industry to improve the operation of flight Analyze and test the new process.
crews. The concept emphasizes the role of human factors in high-
stress, high-risk environments. It encompasses team training, simula-
tion, and interactive group debriefings, as well as measurement and Step 8
improvement of aircrew performance.1 The goals of effective CRM are Implement and monitor the
increased safety, efficiency, and customer satisfaction. redesigned process.
19
Varying by the sources consulted, FMEA can involve from as RCA and FMEA are interrelated. Each approach can be used
few as four to as many as 10 different steps. The approach during portions of the other approach. FMEA can be used
described in this book has the following eight key steps: during an RCA to help evaluate various proposed improve-
1. Select a high-risk process. ment strategies that resulted from the RCA. FMEA can look at
2. Assemble a team. where the various processes might fail and identify any new
3. Diagram the process and brainstorm potential failure failure modes that have been introduced as a result of new
modes and their effects. process designs. RCA can be used to help identify processes
4. Prioritize failure modes. that need FMEA and can more specifically determine the roots
5. Identify root causes of failure modes. of an identified problem. In such a case, a full RCA is not
6. Redesign the process. required, but a critical look at how a failure could occur and
7. Analyze and test the new process. what actions could be taken to prevent or mitigate the effects
8. Implement and monitor the redesigned process. of the failure is appropriate.
A flowchart that provides more detail on the individual steps Analyzing processes after an event occurs must be done with a
can be found in Figure 1-1 on page 21. prospective look at what could go wrong with processes and
procedures throughout the organization. If both tools are not
The ultimate goal of FMEA, when used in health care, is to used, the organization runs the risk of jumping from one ret-
prevent bad outcomes and ultimately prevent harm. The great- rospective analysis to another, responding to events as they
est strength of FMEA lies in its ability to focus users on the occur rather than prospectively designing or redesigning
process of redesigning potentially problematic processes to pre- processes to prevent bad things from happening. Chapter 5
vent the occurrence of failures. FMEA can be effective at iden- provides more information about RCA as it relates to FMEA.
tifying system vulnerabilities, but it must be used as part of an
ongoing, comprehensive quality improvement or performance Why Use FMEA?
improvement process in order to effect change. In other words, The fundamental reason health care organizations should con-
FMEA is an important tool in a health care organizations per- duct FMEA is that it has been proven to reduce the risk of
formance improvement arsenal. error and increase the successful performance of a process. In
health care, this could mean a decreased likelihood of a mis-
The Difference Between Root Cause take occurring and improved safety. The safety of individuals
Analysis and FMEA receiving care, treatment, or services must be a priority for all
Root cause analysis, or RCA, is a technique that The Joint health care organizations.
Commission and Joint Commission International require an
accredited organization to use after a sentinel event has The Joint Commissions Leadership and Improving
occurred to identify the events underlying causes. Whereas Performance chapters and Joint Commission Internationals
RCA is primarily a reactive approach to systems analysis, Quality Improvement and Patient Safety chapter provide a
FMEA is primarily a proactive approach to the prevention of framework for helping to reduce the risk to and ensure the
systems-related failures. Both are important tools for health safety of individuals who receive care, treatment, or services in
care organizations as both are key to an organizations perform- various health care settings. Through these chapters, leadership
ance. can define and implement a proactive system for identifying
risk and reducing the risk of health care process or system fail-
RCA and FMEA share the following characteristics: ures that cause harm. For more information on the standards
Both must have the support of leadership. and requirements, see the applicable comprehensive or inter-
Both have the goal of reducing the possibility of future national accreditation manual that fits your organizations
harm. needs and population served.
Both involve identifying conditions that lead to harm.
Both are nonstatistical methods of analysis. Enhance Performance
Both are team activities that require people, time, materi- Safety is only one, albeit the most important, of many dimen-
als, and support. sions of performance. Process improvement made possible
with FMEA can enhance numerous and, at times, perhaps all
20
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 3642, Mar. 2009. Used with permission.
21
dimensions of an organizations performance. For example, use Improve Financial Performance

of FMEA to improve the medication utilization process could FMEA involves a relatively small amount of time, resources,
enhance the efficacy and appropriateness of a medication reg- and finance when compared to the potential return on any
imen, the availability of medications needed in emergency sit- investment in this technique.2 Unlike many other tools, FMEA
uations and, thus, the timeliness with which nurses administer can yield significant results and financial savings without
medications to individuals in need. FMEA could lead to requiring complicated tools and statistical analysis.
improved effectiveness of the process by which a medication
order is transcribed; the continuity of a care recipients medica- Evidence in engineering literature indicates that use of FMEA
tion history related to relevant practitioners; the safety of the can help improve an organizations financial performance. As
individual receiving an error-prone, high-alert medication performance data are collected about use of FMEA in health
such as injectable potassium chloride or phosphate concen- care organizations, bottom-line results may also be similarly
trate; and the efficiency with which medications are properly impressive. As health care leaders are well aware, health care
labeled in the pharmacy. Finally, FMEA could be used to has several bottom lines. Financial performance is one;
improve the respect and caring an individual receives through another is the safety of care recipients. It is unrealistic for
effective pain medication management. organizations to expect FMEA to always yield a financial
return on investment. Rather, the goal of proactive risk assess-
Improvement of the safety dimension can sometimes negative- ment is cost avoidance, not cost reduction. If potential process
ly impact other dimensions; for example, timeliness is fre- failures never actually occur, a sentinel event with cost impli-
quently negatively impacted by increased safety, because cations to the organization may be avoided.3
adding safety checks and balances to a system can increase the
time needed to complete a particular task. The time added Enhance Team Approach
may be insignificant in some cases, but in others it can cause a Another key benefit of FMEA is its team orientation. Many
greater impact. When considering changes based on the results health care organizations are growing accustomed to a team-
of an FMEA, leadership will need to consider carefully and based approach in their care areas, and teams that function
weigh the trade-offs between increased safety, timeliness, and well can accomplish more than individuals could separately.
affordability. 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 Teams also provide a powerful and often successful way to effect
quality improvement tool. FMEA narrows or eliminates gaps systemwide improvement. Use of FMEA by teams enhances
in quality and performance by helping identify areas where communication, collaboration, and understanding organiza-
quality improvement is necessary. An organization can benefit tionwide. At the same time, health care leaders need to recog-
when it incorporates FMEA into its quality management and nize that a team-based activity requires people, resources, and
performance improvement programs. The performance time. To realize the benefits of FMEA, leadership must be will-
improvement program of an organization provides the data ing to provide the time and people required to conduct FMEA
and information needed to accurately identify real or potential in a thorough and credible manner.
failure modes and improvement opportunities.
Limitations of FMEA
Regularly conducting proactive risk analysis using a tool such While FMEA is an effective tool, it is by no means perfect.
as FMEA can help shift an organizations culture from one of There are several limitations to the approach, which an organ-
reaction and response to one of interactive risk management ization can overcome if it recognizes them. One of the signifi-
and error prevention. By moving toward multidisciplinary col- cant limitations of the tool can also be seen as an opportunity:
laboration, which yields performance improvement projects significant staff time and resources are typically needed to con-
that result in team-based processes and systems, an organiza- duct FMEA, and organization leadership must be committed
tion can reap the benefits of an open culture, in which errors to providing those resources or the analysis is doomed to fail.
are anticipated and addressed, staff feel valued, and individuals However, by providing the resources, organization leaders can
receive safe, high-quality care. set the stage for collaborative, team-based quality improve-
22
Chapter 1: Failure Mode and Effects Analysis Overview
ment, which, in the long run, can have a huge impact on safe- must be an integral part of an overall quality management
ty and quality in the organization. process or plan. A properly conducted FMEA will be con-
firmed by the measurement system.
Another limitation of FMEA is that it cannot reveal the com- 4. Effective information management. The organization must
plete consequential and causal sets of any singular error or be committed to obtaining, managing, and using infor-
adverse outcome. An FMEA may appear to show that a specif- mation to improve outcomes. Effective FMEA depends
ic error could cause a specific injury, but whether it would on reliable and available data about the performance of
actually cause that injury requires analysis of the actions of all processes and FMEA results. Data must be uniform,
other persons and of all states of all systems and devices that timely, and accurate, and procedures and processes must
might possibly be involved.5 FMEA should be used as a tool to be well documented to reduce unnecessary variation.
anticipate possible problems and address hypothetical situa- 5. Well-trained and qualified personnel. FMEA teams include
tions. In other words, it is not a predictor of failure so much as individuals who are trained in the use of FMEA and other
a formalized process of what if. performance improvement techniques and tools and who
are knowledgeable about the processes under study.
FMEA allows a team to consider only one failure at a time.
There is no logical process in the tool for considering multiple Health care leaders and staff must try to anticipate any barri-
or interacting failures, and adverse events typically are the ers they might encounter when conducting an FMEA and
result of multiple failures and preexisting hazardous condi- determine strategies to remove such barriers. Removing cultur-
tions. Thus, FMEA users will need to consider the interrela- al barriers, such as not viewing FMEA solely as an initiative
tionships of failure modes. To help in this effort, other safety but as a performance improvement initiative, may be harder to
improvement techniques, such as a fault-tree analysis, should address than process information/management barriers, such
be used in conjunction with FMEA. Chapter 5 provides more as having the data needed to analyze processes in depth.
information about fault-tree analysis. Sidebar 1-1, page 24, outlines common pitfalls and barriers to
FMEA success. To this list could be added cultural barriers that
Laying the Groundwork for Success exist when a blame and shame approach to problems exists
Before diving into the FMEA process, it is important to lay the in an organization. In such instances, organizations frequently
groundwork for successful results. The greater the thought focus their efforts on blaming individuals. The result is that
given to relevant issues prior to commencing the FMEA, the staff may be unwilling to participate fully in FMEA, thereby
greater the likelihood of its success. The following are five key limiting the approachs usefulness.
elements to successful FMEA:
1. Leadership support. As mentioned earlier, leaders must be Chapter 2 addresses steps 1 and 2 of FMEAchoosing a
committed to the FMEA process as a proactive risk assess- process and assembling a teamthe beginnings of any process
ment. Leaderships guidance in the importance of FMEA improvement project.
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 lead-
ership must allot include the required people, time, mate-
rials, support (such as data analysis), and money.
2. A focus on and commitment to safety. This ensures the iden-
tification and improvement of processes that could pres-
ent a safety risk to the individuals served by the organiza-
tion. 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
23
References
Sidebar 1-1. Pitfalls to FMEA 1. Pizzi L., Goldfarb N., Nash D.: Making health care safer: A critical
analysis of patient safety practices. Evidence Report/Technology
Following are some of the common pitfalls experienced Assessment. No. 43. AHRQ Publication No. 01-E058, Jul. 2001.
by teams conducting FMEA: Agency for Healthcare Research and Quality, Rockville, MD.
Conducting FMEA just to fulfill a requirement. The http://www.ahrq.gov/clinic/ptsafety/ (accessed Mar. 5, 2010).
desire for improvement should come from within. If it 2. Spath P.: Using failure mode and effects analysis to improve patient
safety: Home study program. AORN J 78(1):1637, Jul. 2003.
is clear to team members that the FMEA is being con-
3. Salas E., et al.: The role of teamwork in the professional education
ducted simply to fulfill an administrative obligation or of physicians: Current status and assessment recommendations. Jt
comply with regulatory requirements, the full benefit Comm J Qual and Patient Safe (31)4:185202, Apr. 2005.
of the analysis will not be realized. Team members 4. Senders J.W.: FMEA and RCA: The mantras of modern risk
should be passionate about the topic and about management. Qual Saf Health Care 13(4):249250, Aug. 2004.
improving safety. 5. Spath P.: Worst practices used in conducting FMEA projects. Hosp
Choosing a process that is too complex. Many health care Peer Rev 29(8):114116, Aug. 2004.
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 devel-
op 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 3642, Mar.
2009; Sheridan-Leos N., Schulmeister L., Hartranft S.: Failure
Mode and Effect AnalysisTM: A technique to prevent chemotherapy
errors. Clin J Onc Nurs 10:393398, Jun. 2006; Spath P.: Worst
practices used in conducting FMEA projects. Hosp Peer Rev
29:114116, Aug. 2004.
24
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
Step 1
assemble a team.
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.
Step 2
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 Step 3
within the health care organization (for example, the process for accu- Brainstorm potential failure modes
rately programming and operating a new infusion device), or they may and determine their effects.
be ongoing ones that potentially or actually are problematic (for exam-
ple, the process for ordering and storing medical gases). They may be
clinical in nature, relating directly to the provision of care, treatment, Step 4
or services (for example, the restraint-use process), or nonclinically ori- Prioritize failure modes.
ented, relating indirectly to the care received by individuals (for exam-
ple, the process used to communicate test results to physicians and
other care providers; or the orientation, training, and competence
Step 5
assessment of staff in identifying individuals at risk for falls). A portion
Identify root causes of failure
of the processor subprocesscould be particularly fraught with risk
and, hence, could benefit from FMEA; for example, the blood unit
modes.
labeling process might warrant FMEA within the overall blood trans-
fusion process.
Step 6
Before a formal analysis has been conducted, organizational experience Redesign the process.
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 asso-
ciated with similar types of sentinel events in health care organizations Step 7
that provide similar care and services. Health care leaders and staff Analyze and test the new process.
should track these processes as part of their performance improvement
efforts.
Step 8
Characteristics of a High-Risk Process Implement and monitor the
High-risk processes generally have one or more of the following char- redesigned process.
acteristics1:
25
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 citys largest health care providers. The organization is the
regions 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.
Wed 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 werent
necessary because the lab system batched these orders and they were waiting for an appropriate batch collection time.
Not only was this an inefcient 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 the steps in a consistent manner. Because health care
require care and services are the principal inputs to a inputs (the individual being served) are so variable and
process. Individuals variability is high: they may be very need to be accommodated, it is very difficult to achieve
sick, have comorbidities, be receiving other treatments, or process consistency. Practice parameters, protocols, and
have differing care preferences. In addition, the staff car- clinical pathways all aim to reduce variation in how indi-
ing for the individuals might be highly variable in terms of viduals perform the tasks in a process.
skill level and approach to the task. Health care processes, Tightly and loosely coupled processes. Tightly coupled
therefore, must accommodate the inevitable and uncon- processes have steps that follow one another in such rapid
trollable variability of their principal inputs. sequence that a variation occurring in one step cannot be
Complexity. Health care processes tend to be highly com- responded to before the next step occurs. In fact, many
plex, with dozens of steps, which means they are particu- times people may not recognize that an error has occurred
larly prone to failure. The greater the number of steps and until they are on the next step.2 In tightly coupled process-
handoffs or step linkages, the greater the probability that es, delays in one step throw off the entire process, inputs
something will go wrong due to the interdependence of generally are variable, and steps are nonstandardized. A
the parts and the whole. failure in one step can lead to a cascade of failures as
Lack of standardization. Lack of standardization diminish- each following step attempts to handle an input it was not
es the likelihood that a process will be performed as designed to handle and fails as a result; for example, in the
desired. Individuals performing a process must carry out operating room, an anesthesiologist works within a tight-
26
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
Inadequate training
Individual develops acute and staffing skills mix
resipiratory distress sydrome Inadequate monitoring
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. Reasons 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 for a specific individual, humans can address and solve
opportunity for recovery if one step in the process fails. unanticipated consequences and adjust the process to
Errors frequently occur at the point where one process or avoid harm. This has been called creating safety at the
step overlaps or hands off to another. Loosely coupled sharp end (also see Figure 2-1 above). For example, the
processes, in contrast, are designed to tolerate process inconsistent use of abbreviations for drug dosages by prac-
delays, permit change in the order of sequences, and pro- titioners can result in dosage-level medication errors.
vide alternative methods to achieve process goals. They However, astute pharmacists, nurses, and other health care
also provide opportunities to identify failures and permit professionals can catch such an error before it reaches the
intervention to correct the problems and protect the indi- care recipient. Their ability to do so depends on proper
vidual receiving care. education and training and on regular assessment of their
Dependence on human factors. A high degree of depend- competence to perform a particular function within a
ence on human intervention within a process can lead to process.
variation that could make the process prone to failure. Not Tight and loose time constraints. Tight time constraints can
all human-factor variation is bad, of course: when a be problematic for all types of processes. As the time
process starts to fail or the process is wrong in some way required to perform a process is shortened, coupling
27
between process steps is tightened even in an otherwise

loosely coupled process. This makes it more difficult for Tip: Leadership Responsibilities
someone to identify and respond appropriately to varia- Leadership is responsible for the following:
tion, thereby increasing the risk of failure. Loose time con- Identifying individuals and services considered
straints can be equally problematic. When processes high risk in the health care organization
require too much time, those performing them may not Prioritizing processes that will be addressed by
be able to retain their focus. Boredom and distraction can FMEA
contribute to process failure. Using a collaborative process to develop relevant
policies and procedures
In addition to the previously mentioned characteristics, high- Training staff in implementing the policies and
risk processes are more likely to fail when conducted within an procedures
environment characterized by a hierarchical rather than team-
oriented culture. A hierarchical culture is one in which staff are
hesitant to communicate and collaborate with staff considered of a failure in the process happening are very low, but the con-
above or below them in the hierarchy. For example, a hierar- sequences of the failure are very high. In health care, these con-
chical culture can make nurses and other bedside care sequences may include death and/or disability; and avoidable
providers reluctant to raise concerns or question physicians deaths are not acceptable, however infrequent. Organizations
and pharmacists about medications, dosages, and other ele- must consider these types of processes when deciding what
ments of care. Medication ordering is frequently cited as an issues they are going to study. In addition, they must consider
error-prone system due to organizational hierarchies. Some low-frequency, high-severity failures when analyzing the failure
organization cultures, in fact, may create a hierarchical rather modes of a particular process. Chapter 4 provides more infor-
than team structure for the entire medication use process. mation on analysis of failure modes.
Similarly, verification of surgical sites by surgical team mem-
bers can suffer from hierarchical pressures. Language and jar- New Equipment or Service
gon barriers coupled with a hierarchical culture can present a In addition to conducting FMEA on processes, organizations
particularly dangerous scenario. The manner and degree to might want to conduct FMEA on new services or pieces of
which staff communicates with each other while performing equipment before they go live. In this way, the organization
complex health care processes can affect the process positively can identify potential issues ahead of time and address them
or negatively. before the care recipient is directly affected. Ultimately, a
health care organization should conduct FMEA or another
Other Risk Areas to Consider similar proactive risk assessment technique any time there is a
High-risk processes are not the only ones that can lead to cat- significant process redesign or introduction of a new service or
astrophic failure and thus should not be the only processes piece of equipment.
examined for potential FMEA use. The following are some
other types of processes to consider. New Building Design
FMEA can be used when designing a new building or unit of
Low-Risk Processes That Add Up to Failure a health care facility. Using FMEA, engineers and architects
Small errors in processes can aggregate to produce catastroph- can literally build safety into the design of a structure.
ic outcomes. A series of small errors can build up to create a Designers can interview facility staff in order to understand the
serious problem. When examined individually, no single error processes staff experience every day in providing care. The
is serious enough to do damage; however, when each error is design should be customized to the people who work in the
taken into consideration, the impact is so great as to cause facility as well as processes conducted there.
irreparable harm. Therefore, it is worth trying to fix minor sys-
tem problems in order to prevent more serious outcomes.3 Most benefits of design are direct and measurable. They
include the following:
Low-Frequency, High-Severity Errors Fewer injuries from falls by installing grab bars, reducing
When examining processes for potential FMEA use, health glare in rooms, and widening doorways
care organizations tend to overlook those processes with low- Reduced infections because of conveniently located hand-
frequency, high-severity outcomes. This is where the chances washing stations and High Efficiency Particulate Air
28
Case Study
Conducting FMEA to Prevent Pressure Ulcers
at Gaylord Hospital
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 respi-
ratory problems.
Although Gaylord has been licensed as a long term acute care hospital for decades, most of their patients were rehabili-
tation 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 complexthey 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 preven-
tion 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.
Because of the scope of this FMEA, the initial project team was large. It included a facilitator from the outcomes manage-
ment 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 direc-
tor 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.
29
(HEPA) Filter systems

Fewer medical and medication errors due to proper light-
ing and reduced noise levels Tip: Sources for Identifying High-Risk
Higher levels of efficiency and morale among staff because
Processes
Internal performance improvement data
of pleasant, bright work areas and convenient workstations
Staff feedback
and equipment
Customer feedback
Data from sister, parent, or similar organizations
Sources for Identifying a Process to
on a local, national, or international level
Analyze
Professional organizations and associations
Organizations can look both internally and externally for ideas
Safety organizations
on what specific processes need attention and study using
Government/ministries of health
FMEA.
Association/society/professional literature
Sentinel Event Alerts
Internal Sources
Liability insurance companies
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
ing again. Leadership should not automatically assume that an
variety of sources, including risk management, utilization incident was caused because of someone being careless. Deeper
management, and quality control activities, as well as from system issues could be present that would be overlooked if
infection prevention and control surveillance and report- blame were assumed. Once data are collected from a reporting
ing. Performance improvement data can help identify high- system, the events should be coded so that problems can be
risk processes. Research data and morbidity and mortality examined in aggregate. This allows the organization to spot
data can also be useful. Using comparisons conducted trends and patterns that need attention.
internally over time with similar processes in other organi-
zations or with external sources of information can help The organization can also use certain quality improvement tools
determine whether excessive variability or unacceptable lev- to help identify processes that are ripe for FMEA. For example,
els of performance exist in processes and outcomes. a Pareto chart is a type of bar chart that can be used to identify
Individual receiving care and staff feedback. Staff in particu-
and call attention to a few vital areas or processes that cause
lar will be very aware of processes that are tedious or error- some of the biggest problems.4 Pareto charts can help reduce a
huge process to a manageable size. High-problem areas would
prone or that they continuously work around because of
be reflected in the Pareto chart and thus provide more focus to
bad design. Encouraging staff to come forward and discuss
the FMEA. Chapter 5 provides more information on Pareto
problem processes can help identify some serious problem
charts.
areas of which leadership is unaware. Sources for staff and
the individual receiving care feedback may include surveys,
focus groups, and leadership walkarounds.
External Sources
Reporting systems. Developing voluntary reporting systems
Information disseminated from The Joint Commissions
in which staff report errors, near misses, or processes that Sentinel Event Database (see Table 2-1, page 31), The Joint
generally did not go according to plan can allow an organ- Commission Sentinel Event Alerts, and Joint Commission
ization to collect data on the potentially problematic issues Internationals Sentinel Event Policy* (see Sidebar 2-1, page 33)
can be helpful in making a proactive choice of a problem or an
that are occurring. For such a reporting system to be effec-
area for analysis.
tive, staff must feel comfortable reporting, and it must be
easy to do. Allowing staff to report via questionnaire, voice
All types of health care organizations can experience sentinel
mail, e-mail, or other simple-to-use formats can help
events, including behavioral health facilities, long term care
encourage staff to report issues.
facilities, home care organizations, ambulatory care organiza-
tions, and clinical laboratories, in addition to hospitals.
In addition to making it easy to report, leadership must commit
to not shooting the messenger, but rather learning from the
Organizations worldwide can learn about sentinel events linked
incident reported in order to prevent the problem from happen-
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.
30
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 equipmentrelated 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 systemsrelated event 25 0.4%
Infant discharge to wrong family 8 0.1%
Other less frequent types 782 11.8%
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 Commissions Sentinel Event Alerts, visit the Joint Commissions web
site: http://www.jointcommission.org.
31
Case Study
Conducting Failure Mode and Effects Analysis on
Medication Request Processes at Amerikan Hastanesi
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 physi-
cians, 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 improvement can also provide particularly well-targeted infor-
Commissions Sentinel Event Alert. For example, one issue of mation.
Sentinel Event Alert focused on reducing the risk of infant
abductions and recommends that large maternity units focus An organizations liability insurance company may also be a
on its infantparent identification process. To reduce the risk good source for information on high-risk processes. By look-
of suicide, a behavioral health unit should focus on its suicide ing at the types of processes that tend to be high risk for litiga-
risk assessment process. tion claims, an organization may be able to identify an issue
that could use improvement.2 In addition, an organizations
In addition, health care organizations that are part of a larger chief financial officer can provide input on which organization
network or system can obtain information about high-risk risks have the greatest financial impact. Addressing the expen-
processes from their colleague organizations and parent organ- sive risks may help gain support of leadership because ulti-
izations. Small organizations can network with other organiza- mately there will be a cost benefit for the organization.
tions locally, nationally, and internationally to obtain relevant
data. Making FMEA Manageable
After processes and systems have been identified that would
Professional associations and organizations can also be an benefit from FMEA, how is it determined which ones are most
excellent source of information on high-risk, problem-prone in need of attention? In an ideal world, FMEA would be con-
processes experienced within specific health care fields. ducted with every process and subprocess that exists within a
Literature available through such organizations and commer- health care organization. In the real world, a choice needs to be
cial publishers frequently includes information on problemat- made. How is this accomplished?
ic health care processes and case studies on how specific health
care organizations have improved processes. Web sites of One critical selection criterion is the processs potential for hav-
organizations specifically addressing safety and performance ing an adverse impact on the safety of the individual being
32
served. Leaders should ask and answer the question Which

process is most likely to affect the safety of the individual being Sidebar 2-1. Joint Commission
served? Two or three candidates may emerge. Continue to win- International Sentinel Event Policy
now the process by asking and answering the questions Which
process has the highest potential volume and, thus, the greatest In support of its mission to improve the safety and quali-
likelihood for safety ramifications? and Which process is most ty of health care provided to the international communi-
interrelated to other health care processes and, thus, if problem- ty, Joint Commission International reviews accredited
atic, is most likely to affect multiple processes? organizations activities in response to sentinel events
during the accreditation process. The following apply to
When deciding which process to tackle, it is also important to sentinel events:
choose one process that staff is interested in fixing. FMEA, while A sentinel event is an unanticipated occurrence involv-
valuable, is a labor-intensive process, so without committed sup- ing death or major permanent loss of function unrelat-
port from staff and leadership, FMEA is doomed to failure. ed to the natural course of the illness or underlying
FMEA is most effective when people are passionate about condition.
improving the process.5 A sentinel event may occur due to wrong-site, wrong-
procedure, or wrong-patient surgery.
In addition, when choosing a process to study, be careful not to Such events are called sentinel because they signal a
take on too much. Targeting a complex process for FMEA might need for immediate investigation and response.
be a mistake because the sheer workload involved may cause The terms sentinel event and medical error are not
inadequate analysis, staff burnout, and even anger among partic- synonymous; not all sentinel events occur because of
ipants. an error and not all errors result in sentinel events.
Some processes may not seem complex until the team begins the Goals of the Sentinel Event Policy
diagramming process (covered in Chapter 3). For example, a
The policy has the following four goals:
FMEA team at a British hospital believed that mapping out its
process for the outpatient parenteral antibiotic therapy service 1. To have a positive impact in improving care, treat-
would be relatively simple and could be accomplished in one or ment, and services and preventing sentinel events.
two meetings. As the team diagrammed the process over the 2. To focus the attention of an organization that has
course of four two-hour meetings, it was discovered that the experienced a sentinel event on understanding the
service consisted of 6 processes, 67 subprocesses, and 217 poten- causes that underlie the event, and on changing the
tial failures.6 organizations systems and processes to reduce the
probability of such an event in the future.
The scope of an FMEA project should be limited and clearly 3. To increase general knowledge about sentinel events,
defined so that everyone has a clear idea of whats being studied their causes, and strategies for prevention.
and the project does not go on forever (define a start and end 4. To maintain the confidence of the public and interna-
point). Limiting an FMEA to a subprocess of a more complex tionally accredited organizations in the accreditation
issue might be a way to reduce the FMEA to a manageable size. process.
Focusing on a specific part of a complex process can keep the
team on track and allow timely completion of the project with- Source: 2010 Joint Commission International: Joint Commission
International Standards for Hospitals, 4th Ed. Oak Brook, IL: Joint
out being overwhelming.7 For example, choosing to study the Commission Resources, 2010.
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 high- Assembling the FMEA Team
risk component of the medication administration process, such Following the selection of a process to study, the FMEA team
as the delivery of oral medications, or choose a particular med- should be assembled. This is one of the most critical steps in the
ication to evaluate. This can bring the FMEA down to a more FMEA process. Without the right team members working
manageable size.5 together, the FMEA might not be effective and potentially
33
might not accomplish its goals. An FMEA team should be mul-

tidisciplinary. This ensures that different perspectives or view- Tip: Team Composition
points are brought to the improvement process. In drawing up a tentative list of team members,
check to ensure that the team includes the following:
Identifying the Right Staff for the Job Individuals closest to the event or issues involved
The selection of team members is critical. Teams limited in size Individuals critical to implementation of potential
to fewer than 10 individuals tend to perform with the greatest changes
efficiency. Four to eight people may be the ideal size, but this A leader with a broad knowledge base, who is
depends on the size of the organization, the process being ana- respected and credible
lyzed, and the areas it affects. The case studies featured in this Someone who has decision-making authority
book include successful FMEA teams between four members Individuals with diverse knowledge bases
and more than 20 members.
Team members should bring to the table a diverse mix of counselor, a social worker, and a performance improve-
knowledge bases and should be knowledgeable about and ment or quality management staff member.
committed to performance improvement. The team should A FMEA team looking at a portion of the medication use
include individuals with fundamental knowledge of the partic- process might include representatives from nursing, med-
ular process involved. These are the subject matter or process icine, administration, the pharmacy or the pharmacy sup-
experts. The team should also include representatives from plier, and information technology or management, as
areas that may be directly affected by changes in the process. available.
These stakeholders will be the ones most affected by changes
and will have the most at stake during the redesign. Areas indi- Give serious consideration to the roles assumed by team
rectly affected by changes in the process should also be includ- members. Successful FMEA teams typically are made up of
ed. For example, a representative from nursing will most like- at least the following roles:
ly be included on most FMEA teams. Team leader. This person is knowledgeable, interested, and
skilled both at group consensus building and using
The team might also include an individual with some distance FMEA. The leader guides the team through FMEA while
from the processperhaps someone who is not at all familiar encouraging open communication and broad participa-
with the process, but who possesses excellent analytical skills. tion. This person does not have the last word, but
Functioning perhaps as an advisor or a facilitator, this person instead leads the group to a consensus.
can provide a fresh perspective, unencumbered by the classic Facilitator. This can be the team leader but does not have
thats how weve always done it mentality. At least one indi- to be. This individual should be skilled at being objective
vidual with decision-making authority (a leader) and individ- and moving the team along. Thus, it is best if the leader
uals critical to the implementation of anticipated process and facilitator are not stakeholders in the process being
changes are needed as well. If several FMEA teams are needed evaluated. The facilitators role is to guide the team
to study portions of a large process, team members can overlap through the process and sort out the less critical input
to facilitate integration of FMEA efforts and results. from the contributions that affect safety. The facilitator
can also help ensure that team members complete each
For example, consider the following process scenarios: step and document the results of the FMEA. Because of
A FMEA team studying the restraint use process for ado- the critical role of the facilitator in keeping the team on
lescents might include a representative from educational track, it may be helpful to have a leader in this role that
services, a child care worker, a nurse, an administrative
staff member, and a performance improvement or quality Tip: Team Member Roles
management staff member. Leader
A FMEA team analyzing the resuscitation process for Facilitator
severe traumatic brain injury in the emergency depart- Recorder or scribe
ment might include a neurosurgeon, an anesthesiologist, a Process experts
trauma specialist, an intensive care unit nurse and manag- Representatives of specific health care disciplines
er/director, a respiratory therapist, a pharmacist, a pastoral
34
Case Study
Conducting FMEA on the Opioid Prescribing
Process at the University of Texas
M.D. Anderson Cancer Center
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 med-
ications; 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 accredi-
tation 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.
With the opioid process narrowed down to the prescribing component, the FMEA project was still a significant under-
taking 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 creatednursing, pharmacy, and prescribersso 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 neces-
sary. Ginger Langley, clinical quality improvement consultant, and Virginia Gonzalez, accreditation coordinator, facilitat-
ed the project and coordinated meetings for all three teams.
When you have a large group of people involved in a project of this scope, its 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 crit-
ical care. The leadership support we had was very important in making this happen.
35
team members feel comfortable with and will also take health care industry, a truly interdisciplinary approach is
direction and input from this person when necessary. essential, including the willingness of physicians and hospi-
Recorder. This person is responsible for taking notes or tal administrators to listen to the ideas and concerns of
minutes during meetings and distributing these following nurses and then act on those that are demonstrated to be
each meeting. Many teams decide to rotate this function logical and evidence-based. Culture can stop things dead in
among all team members so that no one person has to take their tracks. You can have redesigned plans and processes
notes all the time. Taking notes can hamper a persons that work well on paper but implementation may or may
ability to contribute fully to the meeting. not go so smoothly, based on team participation, notes
Process experts. These individuals are particularly familiar Fletcher.
with the process under study. Individuals assuming this
role on FMEA teams must be open to process change. If Leadership must actively support improvements achieved
they are not, they can present barriers or obstacles to effec- through interdisciplinary teams.
tive and efficient team functioning.
Representatives of specific health care disciplines. These indi- Training the Team on How to Conduct
viduals provide the multidisciplinary orientation that is FMEA
critical to the FMEA team. Individuals stand in for their What training should team members have before starting a
discipline. For example, the respiratory therapist on the FMEA? Team members need not be familiar with FMEA prior
FMEA team represents the interests and views of his or to starting the process. A leader or facilitator who is trained and
her respiratory therapy colleagues during team meetings. knowledgeable about how to conduct a FMEA can guide team
Different health care disciplines typically view the process members through the process. He or she may want to give a
from unique perspectives. brief how to lesson during the first meeting of the team.
Although these roles are all important, it is also critical that at Team members should be familiar with how to contribute to
least one member of the team be a champion for the effort. and participate on an improvement team. Familiarity with per-
This individual believes fervently in the cause (in the case of formance or quality improvement tools and techniques, such
FMEA, the improvement of a certain process) and can effec- as flowcharts, brainstorming, cause-and-effect diagrams, mul-
tively motivate others through personal enthusiasm and initia- tivoting, and RCA, is also helpful.
tive. It is most helpful when the champion is an individual
with a measure of influence, such as an individual in a leader- Establishing the Team Mission, FMEA
ship role in the organization. Scope, and Ground Rules
Before the team begins to work, the leaders of the health care
Leadership's Influence in Team Development
organization must establish the teams mission and ground rules.
Leaders lay the groundwork for effective team development by
Sidebar 2-2, page 37, provides a checklist of tips for FMEA team
creating an environment that is conducive to improvement
success.
through team initiatives. Leaders must articulate their com-
mitment to FMEA and empower the FMEA team to make
Consider the following: Is the team charged with the responsibil-
changes or recommendations for improvement.
ity of conducting the FMEA and recommending improvements?
Or is the team charged with the fuller mission of conducting the
In addition, participation of physicians and other medical staff
FMEA, recommending improvements, obtaining approval for
members (as applicable to the care needs setting) on FMEA
the recommendations, and implementing and monitoring the
teams is critical. Leadership must understand the barriers to
approved improvements? Leaders must also determine whether
engaging the medical staff and take steps to overcome those
the FMEA team needs to follow the improvement process used
barriers. In some organizations, this can be a cultural chal-
by other improvement teams.
lenge. In a published case study, Carol E. Fletcher, Ph.D.,
R.N., comments on the challenges the nursing staff of one
It is helpful for the team to know ahead of time whether there are
hospital faced in implementing improvements to reduce the
any limitations to redesign efforts. For example, if the redesigned
risk of heparin administration errors8:
process requires expenditure, such as a new piece of equipment,
For any meaningful reduction in errors involving medica-
is that something leadership is willing to support? If team mem-
tion administration [or other processes] to occur in the
36
bers are not given the parameters within which they must work,
then valuable time can be wasted working on redesigns that are Sidebar 2-2. Checklist of Tips for
not currently possible for the organization. Successful FMEA Teams
As mentioned previously, leaders provide the resources needed by Ensure that the team objective is well defined with
the team, in the form of time, materials, support services, and established scope boundaries.
money. They determine deadlines and outline how results should Obtain a skilled and effective leader and facilitator
be communicated to others in the organization. for the FMEA team.
Before the FMEA team meets for the first time, or at the first Ensure visible top leadership support for team activi-
meeting, it is helpful to ensure that the scope of the FMEA is as ties.
accurately, clearly, and specifically defined as possible. One way Ensure that teams are multidisciplinary and include
leaders can perform this function is by putting in writing a sim- process owners and frontline staff.
ple statement (perhaps only one or two sentences) about the Emphasize, support, and monitor attendance.
FMEAs scope. The leader may work alone or through a team Management must support adequate time off from
process. In either case, the FMEA team reviews the statement and clinical duties for staff to attend FMEA meetings and
discusses it until each team member understands it. If clarifica- compensation for meeting time. Overrecruit front-
tions or revisions are required, they are documented in writing. line staff to ensure that at least one person from every
discipline attends each meeting.
In addition to the scope of the FMEA, the team should be pro-
Assess baseline knowledge of the FMEA process and
the process and/or technology to be evaluated. Train
vided with as much information about the current process as
team members to assure adequate knowledge before
possible. For example, if data on the previous process problems or early in the team process.
are available, it is valuable to share those data with team mem- Inform team members of expected time commitment
bers. This can help them understand why the project is impor- based on FMEA project scope. Long processes and
tant and any aspects of the process that require focused atten- technology evaluations will take months to complete.
tion.2 Plan related technology implementation for months
after the FMEA team has completed its work to
Because a health care process is usually very complex and inter- allow time for needed process and technology
relates with or affects other health care processes, the leader changes.
might want to divide the process into subprocesses, define Encourage and support communication and active
them, and assign subteams to work on each subprocess. For participation among team members. Be aware of
example, it might be done initially for individual subprocesses; grouping and dominating team members.
these results can then be integrated to provide an FMEA for an Monitor progress of FMEA team toward its goal.
entire process comprising many subprocesses. Evaluate outcomes of FMEA team, and develop les-
sons learned for future FMEA teams and similar
team activities.
Tip: Establish the Meeting Time Source: Wetterneck T.B., Hundt A.S., Carayon P.: FMEA team
The meeting time established for an FMEA team can performance in health care: A qualitative analysis of team member
perceptions. J Patient Saf 5:102108, Jun. 2009. Used with
have a major impact on the ability of some team 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 Using a Checklist
staff can come to work early for the meeting, after- Use of a checklist or form can be very helpful during the pre-
noon-shift staff can stay late, and day-shift staff can liminary startup phases of FMEA (see Figure 2-2, page 38). A
return to the organization for the evening meeting. checklist is one of the easiest tools teams can use to identify
This can work only if leadership addresses the various options, needs, or resources. It is most valuable early in
staffing issues associated with this, such as overtime the FMEA process, to ensure that the teams purpose is clearly
pay for extra hours. defined and that the FMEA proceeds smoothly during the cru-
cial 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, check- Does the team include individuals who are critical to imp-
list questions focus on the breadth, scope, mission, and ground lementing potential changes, a leader with a broad knowl-
rules of the assembled team. Relevant questions include the edge base, an individual(s) with decision-making authority,
following: and individuals with diverse skills and knowledge?
Has the scope of the FMEA been clearly defined? Has the team identified the required resources?
Does the team know what its mission is? Is the team aware of the expected time frame for complet-
Is there a team member for each key department or disci- ing the FMEA?
pline affected by the process being analyzed? Does the team know how its results should be communi-
cated and to whom?
38
To create a checklist, your team can do the following: of accountability should be established for team members
Assign a team facilitator or leader to draft a checklist. This so that assignments do not get pushed aside when the
gives the team something to react to. team member returns to his or her regular duties. The
Ask for input in customizing the list and revise it accord- efforts of one team member will directly affect the efforts
ingly. of other team members.
Frame all questions to elicit positive answers as go-ahead Other rules. The team needs to discuss all other rules that
signals. members feel are important. These can include whether
Work through the questions one at a time, until it reach- senior management staff can drop in, whether pagers and
es a consensus on each. cell phones should be checked at the door, what the break
Proceed with the FMEA only when it can answer yes to frequency is, and so on.
each yes/no question.
Setting the tone early on of how the team will interact is
Once a general checklist for FMEA has been created, use it as important to the teams success. Team members should be
a tool to help prepare for future FMEAs. encouraged to openly communicate with each other and dis-
cuss issues and differences in a constructive way. One particu-
Establishing the Rules of the Road lar dynamic that is critical to successful teams is the issue of
At the first team meeting, the FMEA team leader needs to trust. Teams that trust each other are more likely to get things
establish ground rules that will help the team avoid distrac- accomplished than those that do not.
tions and detours on the route to improvement. The following
ground rules provide a framework that allows teams to func- Now that the process and team have been chosen, it is time to
tion smoothly: begin analyzing the process. Chapter 3 will discuss how to con-
Decision making. The group must decide what kind of duct this step of the FMEA.
consensus or majority is needed for a decision, recogniz-
ing that decisions belong to the entire team.
Attendance. Attendance is crucial. Constant late arrivals
and absences can sabotage the teams efforts. It is impor-
tant to set guidelines for attendance. Unlike committees
that meet for a long period of time for an ongoing pur-
pose, an FMEA team meets on an ad-hoc basis for short-
er 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 con-
tinue 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
39
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. 178198.
2. Spath P.: Home study program: Using failure mode and effects
analysis to improve patient safety. AORN J 78:1544, Jul. 2003.
3. Smith M.: To assume is human. Physician Exec pgs. 5658,
May/Jun. 2004.
4. FMEA: A new QI tool to help improve case management processes.
Hosp Case Manag 11:3348, Mar. 2003.
5. Spath P.: Worst practices used in conducting FMEA projects. Hosp
Peer Rev 29:114116, 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 62:177183, 2008.
7. De Rosier J., et al.: Using Health Care Failure Mode and Effect
Analysis: The VA National Center for Patient Safetys proactive
risk analysis system. Jt Comm J Qual Improv 28:248267, 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
3:6672, Feb. 2002.
40
Chapter 3
Diagramming the Process

and Brainstorming Potential
Failure Modes
Step 1
Diagramming the Process Select a high-risk process and
The next step in failure mode and effects analysis (FMEA) is to review assemble a team.
the process in full by describing or diagramming it in a graphical for-
mat. Multidisciplinary participation of FMEA team members and all
others involved in the process is vital to the identification of each and Step 2
every step of the process, which may be more complex than previous- Diagram the process.
ly 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 Step 3
process and other care processes. FMEA teams might want to draw on
Brainstorm potential failure modes
various individuals who have expertise related to selected steps or
and determine their effects.
processes.
Teams might find that the process seems too large and complex to
manage in one diagram. Breaking the process into component sub- Step 4
processes and diagramming each of them may be helpful. Using an Prioritize failure modes.
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. Step 5
When diagramming, team members should ask themselves the follow- modes.
ing 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
Step 6
process, how should it occur?
Redesign the process.
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?
Step 7
Analyze and test the new 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 man-
ner as possible. The more detailed the diagram, the more effective it
will be. Keep in mind that difficulties are likely to be encountered dur- Step 8
ing the diagramming process. These probably reflect confusion about Implement and monitor the
the process. The team can work through conflicting and confusing redesigned process.
points to reach a resolution.
41
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 process as it usually occurs in normal circumstances. By compar-
Flowcharts (or process maps) are perhaps the most commonly ing the two charts, the team can more easily identify redundan-
used tool for helping teams understand the steps in a process. cies, inefficiencies, misunderstandings, waiting loops, and deci-
One of the oldest quality improvement tools, a flowchart is a sion points, all of which can create process failures. During the
graphic representation of the path a process follows (or should process design or redesign stage, a flowchart can also be used to
follow) from start to finish. A flowchart can depict the sequence show the desired path the new or redesigned process is to follow.
of steps as designed and as actually performed. These often are
not the same. The team might want to create two separate flow- Symbols used in traditional flowcharts generally are consistent
charts: one that outlines how the process is intended to occur as (with only minor variations) and easy to learn (see Figure 3-1
defined by policies and procedures, and one that follows the above). Flowcharting software, which is readily available on
42
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 flow-
chart 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
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. Physician writes order 1A. Unable to read orders
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

3A. Order not entered
order into system
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

4A. Paper record not in chart
in out rack
5. Nurse compares paper chart to 5A. Chart order not compared to

computerized record computerized order
5B. Nurse does not view computerized orders
6. Nurse acknowledges orders in computer 6A. Nurse does not acknowledge orders
system properly
7. Lab receives and interprets electronic 7A. Lab tech does not receive intended
order information
8. Nurse or lab collects specimen 8A. Baby is stuck unnecessarily
9. Lab conducts analysis None identified
10. Lab enters results into computer system None identified
44
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 bound-
aries. 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 conclu-
sion. When considering how the process actually is performed, teams should consider caregiver-to-caregiver, unit-to-
unit, 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 Avoiding Common Mistakes
flowcharting process as a whole. Several of the following strategies can help teams avoid com-
mon mistakes when diagramming a process1:
Another type of flowchart teams might want to use is called an Ensure that the flowchart is constructed with help from
event line. This type of flowchart does not use all the symbols the individuals actually performing the work being chart-
found in traditional flowcharts. It consists of boxes that con- ed so that it reflects reality.
tain each of the steps involved in a process with arrows that If the process seems too complicated to be flowcharted on
connect them. one or two pages, break the overall process down into
manageable chunks or subprocesses and create a flowchart
To maximize the time of team participants, leaders can choose for each of these. Teams should recognize, however, that
to develop an initial draft of a flowchart before the first FMEA there are some risks associated with doing this. The link-
team meeting. This gives the team something to react to and ages between the subprocess steps must not be forgotten.
can provide a starting place for discussion. However, regardless For example, a team that diagrams the subprocesses with-
of whether an initial draft of the flowchart is available, the exis- in the medication use process cannot forget the linkages
tence of each and every step must be confirmed and verified, between the medication prescribing process and the
and the draft flowchart should be tweaked, finalized, and preparing and dispensing processes. Failures can occur in
approved by the team as a whole. For more on how to create a numerous ways during this handofffor example, when
flowchart, see Sidebar 3-1 above. An example of a completed the order is entered into the computer system, when the
flowchart is provided in Figures 3-2 and 3-3, pages 4647. pharmacy staff calls the prescriber to verify an order, or
45
Figure 3-2
Example Flowchart: Radiation Treatment Planning Process
Compose Plan
Planning treatment Plan exported
PDFs plan exported into
yes sent to document patient
Place Generate Plan acceptable eChart D&I
calculation treatment to dosimetrist &
points plan M.D.?
PDF Compose
reports treatment Export Associate
no of DRR DRR DRR DRR with
sent to document appopriate
eChart fields
Export
QA data Tx calendar
IMRT setup
dose
plane
M.D.
no reviews final
plan and
prescription
R&V = record and verify; Tx = treatment; IMRT = intensity-modulated
radiation therapy; TP = treatment plan; D&I = diagnosis and intervention; yes
QCL = quality checklists.
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. as blocks connected together by lines that describe how
Be sure that all process and subprocess steps are identified the process components or steps are related. The diagram
before proceeding. If a team fails to identify all the steps, shows the logical relationships between steps and estab-
it will not be successful in identifying failure modes, their lishes a structure around which the FMEA can be devel-
root causes, and relevant process redesign strategies. oped.
Although developing a flowchart is the most common way
of diagramming a process, teams can use other methods. Walk Through the Process
For example, list the steps in a process, place a number by It can be very beneficial to walk through the process under dis-
each step, and organize the steps in order of occurrence. cussion. This exercise allows the team to identify how the
Or create a block diagram of the product or process. A process actually occurs. Walking through the process can help
block diagram shows major components or process steps assist with creating the flowchart, and after the initial flow-
46
Figure 3-3
Example Process Map: Medication Reconciliation Process
chart is created, it can help verify each step, its sequence, and wrong and thereby helps the group start to identify some of
any variations in its day-to-day performance. the failure modes.
Individuals with expertise related to each step can verify the Identify Potential Failure Modes
sequencing of the step, the proximate decision points, and the After the diagram of the process has been created and verified
handoff or linkage to the next step. Walking through the by the team, it is time to begin the task of identifying failure
process as it actually occurs helps identify the difference modes. A failure mode is any event that is the cause of a func-
between the intended process and the actual process. Processes tional failure. This must be distinguished from the failed state
do not necessarily occur as designed. Changes in steps and of a process or system, which is the effect of a failure mode.2
their sequence may occur for any number of reasons, such as Any step in a process can fail, and each failure may have many
staffing, competence, and care population. Walking through failure modes.
the process provides the team with clues about what could go
47
Identifying failure modes requires team members to think

outside the boxbeyond the normal scope of everyday prac- Tip: Brainstorming Ground Rules
tice and vision. It means trying to do such things as generaliz- There is no such thing as a bad idea. All ideas are
ing, broadening, and removing the constraints with which one valuable, as long as they address the subject at
normally approaches a task. It involves thinking of the process hand. The leader should express this as part of his
as a system and focusing on the relationship of the parts to a or her introductory comments.
whole. Although human nature is inclined to break down large Quantity, not quality, is the goal. More ideas are
problems into smaller manageable parts, the challenge is to better. Build on each others ideas.
retain the ability to see the big picture as the focus shifts to Never criticize other peoples ideas. It is crucial
individual processes. that neither the leader nor the other group
members comment on or react to any given idea.
Brainstorming Potential Failure Modes Remember that the best ideas are sometimes the
Brainstorming is a structured and creative process that a group most unusual.
of people use to generate as many ideas as possible in a mini- Only one person should talk at a time.
mal amount of time. Brainstorming stimulates creativity and Do not interrupt someone offering an idea.
encourages many perspectives on an issue. If properly conduct- Post the ground rules on the wall so that no one
ed, brainstorming provides a safe environment for team mem- will feel personally challenged when he or she
bers to express ideas, and it can strengthen the team as a whole. breaks a rule.
Brainstorming is not an end in itself. The ideas generated

through the process have to be assessed and refined. However, Steps in the Brainstorming Process
brainstorming is a starta way of moving toward an identified Effective brainstorming can be accomplished in the following
goal of process improvement. The objective of brainstorming five basic steps:
potential failure modes is to identify, within a finite period of 1. Define the subject of the brainstorming session. This ensures
time, as many ways as possible that a process can fail, both at that the session will have direction and that ideas will not
each step in the process and in the linkages between the steps. be too dispersed to be useful. Make sure that everyone
understands the focus before ideas start flowing. Limit
Establishing Ground Rules brainstorming to one level or process step at a time.
The ground rules for brainstorming sessions should be estab- 2. Think briefly about the issue. Allow enough time for team
lished before the actual session is conducted so that all partic- members to gather their thoughts but not enough time for
ipants will understand them. Some experts suggest that the detailed analysis. Do not give the team time to second-
best way to have meaningful ground rules is to have the team guess their ideas. Be aware that self-censorship will stifle
create its own. Perform a mini-brainstorming session around creative thought.
creating brainstorming ground rules. This should provide an 3. Set a time limit. There should be enough time for every
opportunity to practice the skills necessary for an effective member to make a contribution, but keep it short to pre-
brainstorming session. Then post the rules so that they are vis- vent premature analysis of ideas. A time limit of 10 to 20
ible to all in the room and can be enforced without making minutes for generating a list of potential failure modes with
enforcement feel personal.3 each step and handoff may be appropriate and effective.
4. Generate ideas. A team can use a structured format in which
Planning for a brainstorming session is critical. Poorly planned the members express ideas by taking turns in a predeter-
sessions can be more harmful than helpful. Leaders should give mined order, and the process continues in rotation until
serious consideration to the space in which the brainstorming either time runs out or ideas are exhausted or an unstruc-
session is held. Is it a nonthreatening, safe environment for tured format in which group members voice ideas as they
expressing ideas? Can a door be shut to provide privacy and come to mind. The scribe should write down all ideas on a
minimize distraction or interruption from those passing by? chalkboard or easel so that the group can view them. In
What materials will be needed? Who will be the scribe? This addition to recording the ideas on a chalkboard or easel for
needs to be someone who can write down ideas very quickly, easy viewing, consider recording ideas on a laptop comput-
legibly, and accurately so that the flow of ideas is not ham- er. This allows the scribe to send a document containing all
pered. the ideas to each team member immediately following the
brainstorming session. It also creates a document from
48
Case Study
Conducting FMEA on the Psychosocial Assessment
Completion Process at Health Care for the Homeless
(HCH)
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 dont 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 identifying the steps, the team determined potential failures and found that each of the 13 steps, no matter how simple
one might seem, had one potential failure mode.
49
which the team can work to further refine the FMEA and those specific places in a process or system that are susceptible to
makes the next step of grouping ideas more efficient. error or system breakdown. They generally result from a flaw in
Number the ideas so that the next process of grouping the initial design of the process or system, a high degree of
ideas into categories is easier. Numbering also provides a dependence on communication, nonstandardized processes or
goalfor example, trying to get to 10 ideas about what systems, and failure or absence of backup. For example, during
could go wrong at each step. Record exactly what is said. In preoperative procedures, verification of the body side and part to
organizations where team members may not regularly be in be operated on constitutes a risk point.
a centralized location, brainstorming can be done by ask-
ing team members and other staff to submit as many ideas When considering possible failure modes, teams should remem-
as possible about the topic in writing, by voice mail, or by ber to think about the following active and latent conditions
e-mail. definitions4:
5. Clarify ideas. The goal is to make sure that all ideas are Active failures are defined as errors and violations that occur
recorded accurately and are understood by the groupnot at the point of direct interaction between a human and a
judged or analyzed. Clarifications takes place only after system. These include errors made by all caregivers who are
everyone is out of ideas. Do not attempt to remove dupli- involved in the day-to-day care activities. The effects of
cation, put the ideas in sequence, or rank them at this active failures are generally immediate and readily apparent.
point. When brainstorming is through, the team should Latent conditions are more insidious and can often go
have a varied list, not a refined list. unrecognized. They are the consequences of decisions made
in the leadership levels of an organization and could stem
When brainstorming failure modes, teams can consider the fol- from several sources, including resource allocation, educa-
lowing elements: tion and training, and other managerial decisions.
People (for example, staffing level, training, scheduling,
communication, or competence assessment issues) It is important to consider both types of failure because they can
Materials (for example, issues related to availability of sup- both lead to adverse consequences.
plies or misplaced supplies)
Equipment (for example, issues related to availability of Using Additional Resources
appropriate equipment) Ideas generated by the team through the brainstorming process
Methods (for example, issues related to the processes and provide a starting place for determining failure modes. Yet team
procedures that staff use) ideas need not constitute the only resources tapped. Other inter-
Environment (for example, issues related to the safety of the nal resources include leaders and staff not on the FMEA team,
environment, such as infection prevention and control or individuals receiving care by the organization, and other people
hazardous waste) who come in contact with the organization (such as a family
member or friend of the individual receiving care) that may be
Depending on the complexity of the process chosen for FMEA, able to offer a unique perspective. Diversity of viewpoints can
a series of brainstorming sessions, each devoted to one of these offer valuable insight into what could go wrong at various steps
elements or a defined process step or steps, could be appropri- of a process. Staff and care recipient satisfaction surveys, risk
ate. Things could go wrong in any one of several areas. A focus management reports, and performance or quality improvement
on each one ensures the creation of as thorough a brainstorming data can also provide helpful insight about potential failure
idea list as possible. modes and their effects.
Differences between the intended process and the actual process Grouping Ideas into Categories
may have been identified during the flowcharting process. These After all the ideas about what could go wrong (the failure
provide a way to get started. Some failure modes may already modes) are out on the table, the FMEA team will want to organ-
have occurred within the organization but may not have caused ize or group ideas into relevant categories. This ensures that the
any problems yet. If allowed to persist, they might, in combina- team can stay focused without jumping from one type of failure
tion with other process failures, cause harm. to another. Similar ideas will be categorized according to what-
ever categories make sense to the team. Ideas may overlap and be
Identification of risk points can often yield a good failure mode so similar that they need to be combined or consolidated.
list. Failure modes often occur at risk points. Risk points are
50
Case Study
Process at University of Texas
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 like-
ly to happen when they werent with people from the other areas.
(continued)
An affinity diagram is one tool that can help the team creative- add structure to a large or complicated issue or break down a
ly organize a large number of ideas into relevant groupings. It complicated issue into broad categories. Both functions are
provides structure and organization of issues when chaos seems useful in this case.
to exist. Following the brainstorming session, the FMEA team
might have multiple sheets of paper or chalkboards listing Most descriptions of how to construct an affinity diagram
ideas. An affinity diagram can help shape these into something include seven steps. The first three stepschoose the team,
with which the team can cope. An affinity diagram can either define the issue, and brainstorm the issue and record the
51
Case Study Conducting FMEA on the Opioid Prescribing

M.D. Anderson Cancer Center, continued
ideaswill already have taken place as a part of the brain- Overlapping ideas can be combined. It is appropriate for
storming process described earlier. The team then takes the fol- some ideas to stand alone. A cluster can contain any num-
lowing four steps: ber of cards. Often 7 to 10 clusters or groups will emerge.
1. Transfer all the ideas onto index cards or adhesive notes, Reach a consensus on how cards are sorted.
one idea per card or note. Make sure that each idea is 3. Create header or title cards for each grouping. The team
expressed using more than one word. The idea should should discuss each grouping and create a title or header for
have at least a noun and a verb, when appropriatefor it. The team may want to break large groupings into sub-
example, forms are not submitted in a timely manner or groups with subtitles. However, the team should be wary of
staff does not use consistent hand-washing technique. over-refinement at this point if it slows progress. Titles
Arrange the cards or notes so that everyone can see them. must be concise and make sense even when separated from
Some teams place them on a large table; some affix them the individual ideas in their group.
to the wall. 4. Draw the diagram, connecting all header cards within
2. Sort the ideas into groups of related topics. The sorting is their groupings. The diagram usually looks something
done by the whole team, guided only by gut instinct and like a simple organizational chart. Review the diagram
working in silence most of the time, except to agree on gen- with the team and individuals not on the team who may
eral clusters for groupings. If an idea is repeatedly moved be involved with the issues. It may be helpful to post the
back and forth from one group to another, agree to create a diagram in a public place, providing adhesive notes so
duplicate card or note and place one in each grouping. other staff can add their ideas.
52
Table 3-1. Considering Failure Modes and Generic Effects
Possible Failure Modes Possible Generic Effects
Wrong drug No injury
No injury but increased length of

Wrong dosage
stay to monitor effects
Injury with no permanent loss of

Wrong frequency
function
Injury with permanent loss of

Wrong route of administration
function; death
Affinity diagrams can help reassure team members that a seem- Both effects can be problematic. Consider Table 3-1, above.
ingly amorphous problem really does have a recognizable Any one of the possible failure modes listed on the left side of
shape. Chapter 5 provides more information on affinity dia- the table could lead to any one of the possible generic effects
grams; an example can be found in Figure 5-1, page 85. listed on the right side of the table.
Identifying Potential Effects of Failure Failures that occur in process steps nearest to the individual
Modes receiving care are more likely to result in injury or harm than
The second activity of this FMEA is to identify the potential failures that occur earlier in the process. Likewise, errors that
effects of the identified failure modes. This should occur when occur earlier in the process are more likely to result in process
all team members are satisfied that all potential failure modes disruptions such as delays or additional work. However, in the
have been described.5 absence of sufficient quality control mechanisms, even failures
that occur early in the process can reach the care recipient.5
Effects, the E in FMEA, are the results of failure modes. In
other words, what could happen if a failure mode actually FMEA teams should consider the specific effects of a failure
occurs? Effects of failure modes might be direct or indirect, mode. For example, perhaps the wrong drug is given to the
long term or short term, likely or unlikely to occur. In any wrong individual because the prescribers handwriting was not
case, they are the result of the impact of a particular failure legible and was misinterpreted; the effects on the individual
mode on the stability of the entire process or a portion there- receiving the incorrect drug could range anywhere from a
of. A failure effect is the consequence(s) a failure mode has on minor allergic reaction, such as hives, to anaphylactic shock
the operation, function, or status of a process step. The sever- resulting in death. Or illegible handwriting could result in the
ity of effects can vary considerably. wrong drug dosage; the effects might range from receiving a
lethal dose of chemotherapy to experiencing no injury but suf-
Each failure mode may have one or multiple effects. For exam- fering a bit more pain after receiving only one half the pre-
ple, if the FMEA team has identified selecting the wrong scribed dosage of aspirin.
medication as a potential failure mode in its medication man-
agement FMEA, the following two possible effects could be Use of the brainstorming process will help the FMEA team
identified7: identify as many potential effects as possible. The key question
1. The individual is given the wrong dose of medication. to rise with each failure mode is If this failure occurs, what
2. A delay in treatment could occur because time is taken to might the consequences be to the care recipient? The team
secure the right medication. should take time with this step to ensure the identification of
53
Table 3-2. Workarounds and Potential Failures
Workaround Possible Errors Description or Example Data Sources
Staff are required to check

the medication label and
compare this visually with
1. User scans medication
the electronic medication
from patient drawer with-
Wrong medication, dose, administration record Observation
out visual check of med-
route (eMAR) before scanning. FMEA
ication list, medication
They might, however, rely
name, and dose.
on the alarms from scan-
ning as the sole confirma-
tion of correctness
Physicians may not be

trained on, or have log-ins
for, the barcode medication
administration system
(BCMA), and therefore
eMAR access is difficult. Or
2. Physicians do not review Inappropriate monitoring of eMAR data are not present- Interview
eMAR to verify current medication; wrong medica- ed in a manner usable for FMEA
medications tion, dose, route physicians. Therefore, Meeting participation
eMAR is not routinely
reviewed and physicians
are not aware if medica-
tions are administered, held
or omitted, and do not stop
unneeded medications.
BCMA system cannot show

all administration informa-
tion for a particular medica-
tion on one screen; there-
3. User administers medica-
fore, an icon appears to
tion without reviewing Wrong medication, dose, Observation
click to see additional infor-
parameters for medica- route, time FMEA
mation. However, the icon
tion administration.
fails to reflect it if informa-
tion is present or when
information has been updat-
ed, and is thus missed.
Hospitals often require a

second nurse to confirm
medication name, dose,
and patient for high-risk
4. Users bypass policy for
medications. BCMA may be
medication double Observation
set up to require the docu-
check by second Wrong medication, dose, Interviews
mentation of this confirma-
provider, or second nurse route FMEA
tion. Documentation may be
confirms without review- Meeting participation
bypassed by overriding the
ing medications.
medication in the BCMA
system or by a pro forma
confirmation by another
nurse.
(continued)
54
Table 3-2. Workarounds and Potential Failures, continued
Workaround 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
5. User does not check/veri-
nurse verification, but is not
fy patients new medica- Wrong medication, dose,
final until verified. Staff FMEA
tion orders before admin- route
might not verify order for
istering medication.
change in the medication
(dose change, discontinue,
etc.) before administering
the next medication dose in
the eMAR.
Nurse scans medications

but does not scan patient
before administering. ID
6. User administers medica- Observation
wristband may be missing,
tion without scanning FMEA
Wrong patient damaged (by body fluids or
patient ID to confirm cor- Meeting participation
patient), or inaccessible
rect patient. BCMA logs
because patient is sleeping
(and RN wishes not to
disturb patient).
Medication barcode is pres-

ent but not scanned, so
7. User administers medica-
BCMA cannot verify med- Observation
tion without scanning
Wrong medication, dose, ication and dose. FMEA
medication barcode to
route, time Medication barcode may be Meeting participation
confirm it is correct med-
damaged or torn, soaked, or BCMA logs
ication, time, dose.
crinkled. Scanner may not
be available.
Source: Koppel R., et al.: Workarounds to barcode medication administration systems: Their occurrences, causes, and threats to patient safety.
J Am Med Inform Assoc 15:408423, Jul.Aug. 2008. Used with permission.
all potential effects. It can be helpful to identify all the poten- ure modes based on their seriousness or criticality. Chapter 4
tial effects for one failure mode before moving on to another. provides more information about this process.
Asking non-team members to help identify the consequences
of failure modes can also be very productive. Table 3-2, pages Using an FMEA Worksheet
54-55, shows a portion of a teams list of failure modes creat- The teams use of a worksheet that tracks the progress of an
ed to identify the ways in which staff was working around the FMEA is highly recommended at this point. A worksheet doc-
computerized medication system. uments process steps, failure modes and effects, and subse-
quent steps to rate their criticality, determine their possible
At this point in the FMEA process, the team should resist any causes, and identify and implement redesign recommenda-
inclination to concentrate on any one failure mode because of tions. It provides an easy reference or summary of the teams
the perceived seriousness of its potential effect. The next step progress to date and helps the team stay on track with the next
in the process will provide a methodical way to prioritize fail- FMEA steps. Teams can create their own worksheet or adapt
55
Table 3-3. Example FMEA Worksheet
Process Step Item Issue Action
Identify key elements and frequency of quality audits

Organ donor form in Accuracy of data
12b and devise a plan for random audits of charts as well
chart entry
as how the plan will be implemented
Develop a CHECKLIST and ORGAN MAP to be

Concern about used by abdominal transplant coordinators.
confusion when Previously, a similar method was used that allowed
coordinators are the coordinators to track which recipient was
Donor/ working on multi- assigned each organ.
17
recipient form(s) ple donors, The program manager will bring these documents
assigning organs to the larger coordinator group for input and valida-
to multiple recipi- tion.
ents Ongoing evaluation of the design and utility of
these tools. Report after one year of use.
Time gap between

when transplant
Kidney/pancreas pre- Tissue typing department has reported the match-
coordinator is
selection of recipients run list is available for coordinators to use approxi-
asked by trans-
before match run com- mately two hours in advance of the full cross-
plant surgeon to
23 pletedclarify what match list.
identify a potential
data is available for Manager to educate on-call transplant coordinators
recipient and
transplant coordina- about the availability of the list to facilitate recipient
when the match
tors selection.
run is ready for
review
Currently, a hot list is pulled for liver and pan-

creas recipients, which makes it easier for coordi-
Use of computer
nators to address surgeons questions (previous
Kidney/pancreas pre- queries in trans-
surgeries, body mass index, etc.).
selection of recipients plant database
Preselecting kidney recipients is more difficult
23 before match run com- may make prese-
because the list is much longer. A database query
pletedcreate deci- lection of organ
tool can help coordinators start selecting recipients.
sion support tools recipients more
Program manager will design an in-service training
reliable
session for on-call coordinators to learn about
using this tool.
Plan-Do-Study-Act in progress with organ procure-

ment organization and University of Wisconsin labo-
ratory, with two changes being tested: (1) at hospitals
Specimen labeling in donor service areaimproved guidance (verbal
Known, ongoing
39a organ procurement and written) given to staff about elements of obtain-
issue
organization ing and labeling specimens; (2) information technolo-
gy programming change to require double-verification
of key identifiers by staff from organ procurement
organization.
56
Table 3-3. Example FMEA Worksheet, continued
Process Step Item Issue Action
Per group discussion, to be handled on a case-by-

case basis. Operating room staff should promptly
Operating room check report these occurrences to the administrative pro-
Known, ongoing
36 of three signatures on gram director.
issue
organ verification form Consider use of Patient Safety Net to report these.
Relates to surgeons requirement to lead a preop-
erative 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 19:208214, Sep. 2009. Used with
permission.
one used by other organizations. Whether or not the team cre- Table 3-3, pages 56-57, provides an example of an FMEA
ates its own worksheet or adapts one, the team might want to worksheet with action items included.
consider the following points:
Consider and identify possible FMEA worksheet column Now that the failure modes have been identified, Chapter 4
headers. These could include the following: will teach your team to prioritize those failure modes to help
Steps in a process or links between steps focus your process improvement efforts on those likely to cause
Potential failure modes the most harm.
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 worksheets 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.
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
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):768770, Mar. 2000.
60
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
Step 1
those risks that most exceed acceptable limits.1 Once a team prioritizes assemble a team.
failure modes, it is in a better position to identify which ones are most
important to analyze further and address through redesign.
Step 2
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
Step 3
While this may seem like a subtle distinction, one cannot prioritize a Brainstorm potential failure modes
list of items without first specifically determining how important or and determine their effects.
critical each item is.
Determining Criticality Step 4

Criticality is a relative measure of the importance of a failure mode Prioritize failure modes.
based on its consequences, its frequency of occurrence, and other fac-
tors.2 How critical or important a failure mode is depends on the com-
bined influences of several factors. Severity, probability, detectability, Step 5
cost, and timing all play a part in determining the amount of attention Identify root causes of failure
a failure mode requires. When determining criticality or importance, modes.
teams should consider the following criteria related to the failure mode
and its potential effects:
Failure Mode Criteria Step 6

Probability of occurrence of the failure mode (often referred to as Redesign the process.
frequency or likelihood of occurrence)
Detectability
Step 7
Effects Criteria
Probability of occurrence of the effect (If the failure mode occurs,
Analyze and test the new process.
how likely is it to result in the bad effect?)
Severity (How serious is the bad effect when it occurs?)
Step 8
Other Criteria Implement and monitor the
Cost redesigned process.
Timing
Availability of resources
61
Teams should note that probability of occurrence appears in a subjective one that involves use of judgment, intuition, and,
two instances. The first case of its use answers the question at times, imagination. If the effect has been experienced before
How probable is this failure mode? The second case of its use within the health care setting or other similar settings, the
answers the question Given the occurrence of a particular fail- team may be familiar with its severity, and the rating may not
ure mode, how probable is this particular effect? be difficult to determine. If the effect has not occurred within
the organization, professional judgment and imagination may
Determining Severity be required to determine a severity rating. Table 4-1, below,
In this context, severity relates to the seriousness of the injury provides an example severity scoring scale.
or impact that could ultimately result if an effect of a failure
mode occurs. In rating severity, team members should look at Determining Probability of Occurrence
the effect of the failure mode, not at the failure mode itself. The probability of occurrence is the likelihood that something
will happen. The key question the team asks at this point is
How do failure mode and effects analysis (FMEA) teams judge What is the likelihood that this failure mode or effect will
how severe a consequence of an effect might be? The process is occur? The team might want to frame the answer to that
Table 4-1. Example Severity Scoring Scale
Rating Description Definition
Would not be noticeable to individual served and would not affect

1 Minor effect or no effect
the process
May affect the individual served and would result in some effect
3
on the process
May affect the individual served and would result in a major

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

6 Minor injury
process
Would result in a major injury for the individual served and have
8 Major injury
a major effect on the process
Catastrophic effect; a terminal Extremely dangerous; failure would result in death of the individ-
10
injury or death ual served and have a major effect on the process
62
Chapter 4: Prioritizing Failure Modes
Case Study
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 dont have computerized physician order entry, says Gonzalez. Thats a $5 million expenditure
and another major project. Its not something that this group can address at this time, so we cant 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 awaythis 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 tions cannot be summarily dismissed because of low probabil-
a low probability, or 1 in 100,000 chances that something ity of occurrence. Their interaction with other failure modes
could occur versus a high probability, or 1 in 10 chance that it must be considered.
could occur. An instance of a remote failure is a vial of a med-
ication from a pharmaceutical manufacturer containing a dif- Table 4-2, page 64, is an example probability of occurrence
ferent drug than the label says it does. A more probable failure scale. Tables 4-3 and 4-4, page 65 and 66, provide examples of
mode is that a prescription arrives in the pharmacy with illeg- individual organizations analysis of severity and probability of
ible handwriting. Note that FMEA teams determine the prob- occurrence.
ability of occurrence of both failure modes and effects.
Determining Detectability
When a failure mode or effect has occurred in the past, data As a next step, the team can determine a detectability rating for
may be readily available to assist the team in determining each failure mode. Detectability is the degree to which some-
probability of occurrence. When data are not available, teams thing can be discovered or noticed. The key question that the
have to use their professional judgment in estimating probabil- FMEA team asks is If this failure mode occurs, how likely is
ity of occurrence. it to be detected? A high rating indicates that the failure
would not be noticed, thereby placing the individual receiving
In determining probability of occurrence, teams will want to care at risk of experiencing the effect of the failure because no
consider the interrelationship of possible failure mode and pos- corrective action to protect the individual is likely to occur. A
sible effects. Latent conditions can coincide with active failures low rating indicates that the failure is certain to be noticed or
to allow an adverse effect to occur. Teams need to consider the is highly likely to be noticed, thereby decreasing the likely risk
interrelationship and interdependence of both active failure to the care recipient. How tightly processes are coupled is
modes and latent conditions, their probability of occurrence, inversely related to the detectability of failure modes. As men-
and the probability of creating specific effects. Latent condi- tioned in Chapter 2 on page 2627, failures occurring in tight-
63
Table 4-2. Possibility of Occurrence Scale
Rating Description Probability Definition
No or little-known occurrence; highly unlikely

1 Remote to nonexistent 1 in 10,000
that condition will ever occur
Possible, but no known data; the condition

3 Low likelihood 1 in 5,000
occurs in isolated cases, but chances are low
Documented, but infrequently; the condition

5 Moderate likelihood 1 in 200
has a reasonable chance to occur
Documented and frequent; the condition

7 High likelihood 1 in 100 occurs very regularly and/or during a
reasonable amount of time
Documented, almost certain; the condition will

9 Certain to occur 1 in 20 inevitably occur during long periods
typical for the step or link
10
ly coupled processes, whose steps follow one another in rapid human intervention, through an automated response, or through
sequence, are less likely to be detected than failures occurring in system design, such as fail-safe systems to protect the individual
loosely coupled processes, which provide an opportunity to receiving care. For example, some computerized medication
detect failures and permit intervention to correct the problems ordering systems use a fail-safe design that prevents physicians
and protect from harm. from entering a lethal dose of a drug. This barrier can help pre-
vent overdoses. Chapter 6 provides more information about fail-
If a failure is detected, controls, barriers, or other mechanisms can safe designs.
be used to prevent the effect of the failure from occurring, reach-
ing the individual, or harming that individual. Effective barriers To determine the detectability of a failure mode, an FMEA team
provide an opportunity to intervene in some waythrough asks, What are the current controls or barriers to this failure
64
Table 4-3. Example of a FMEA from an Interventional Pulmonology

Program
Hazard ID and Description Status Severity Probability Recommendation
Procedures require that prior to the

medical procedure, do the following:
001 Lack of oxygen in bottles open tank, record pounds of pressure
Open I* D*
attached to anesthesia machines. available, close tank, and bleed tank
lines. Is it still necessary to teach this
with automated machine checkout?
1. Ensure that swivels are reliably

connected to jet vents.
2. Ensure that no safety catheters
002 Inserting an angiocatheter into are stocked in jet vent bags.
the cricothyroid membrane without a Monitor I D 3. Change label on jet vent bag to
swivel may result in harm or death. state One 14 G and one 16 G non-
safety IV catheter.
4. Provide all OR jet vent bags with
checklist label for contents.
003 Safety catheters cannot be

connected to syringe with fluid in it
for insertion into the cricothyroid
Replace the safety catheter with
membrane to aspirate air bubbles
Monitor I D 14 G and 16 G non-safety angio-
and validate correct position in the
catheters.
trachea. Syringes are not always
present in the jet vent bags. Provide
10-cc syringes in the bags.
* 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 35:7281, Feb. 2009. Used with permission.
mode? and What is the opportunity to intervene if the barrier means. For example, if the team is planning to use a 10-point
detects the failure? Table 4-5, page 69, provides an example scale, the team should discuss and agree on the definitions of each
detectability scale. 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
Choosing a Rating Scale of rating failure modes and their effects. Reminding team mem-
Health care leaders and staff should choose the scale they believe bers of the meaning of the different numbers on the scale is
will be most effective; however, that scale should be used consis- important. Some teams put up posters in the FMEA team meet-
tently. For example, a 10-point scale or a 5-point scale can be ing room that outline the scoring criteria.
chosen. Jurans classic quantitative model uses a 10-point scoring
system to rate the severity of the potential effect, frequency of Choosing the Rating Method
occurrence, and detectability of the failure.3 A simple approach may involve team members assigning a qual-
itative (for example, high, medium, low) rating to each failure
No matter what type of scale a team chooses, team members mode. The following section discusses some other methods
should reach an agreement on what each point on the scale 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
Severity Prob. Hazard Single-Point

Potential Case Detectable? Proceed? Action
Score Score Score Weakness
Patient not asked if

Add question to pro-
he or she had dia-
1 4 4 No No No cedure scheduling
betes at time of
form
scheduling
Educate assistant to
Patient response
1 4 4 Yes Yes Yes document screening
not recorded
response
Patient not asked if

he or she had dia-
Develop checklist for
betes at time of 2 4 8 No No No
phone calls
telephone confirma-
tion
Add question to con-

Diabetes status not sent form, instructions
confirmed on day of 3 1 3 No No Yes for patients with dia-
the procedure betes, and request
form
Add question to con-

Diabetes status not sent form, instructions
confirmed at time of 3 1 3 Yes No Yes for patients with dia-
consent betes, and request
form
If patient had dia- Add question to

betes, he or she scheduling form, pre-
was not instructed 3 4 12 No No Yes procedure screening
to eat prior to pro- checklist, and request
cedure form
If patient had dia- Add question to

betes, he or she scheduling form, pre-
was not instructed 3 4 12 No No Yes procedure screening
to take insulin as checklist, and request
needed form
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 35:7281, Feb. 2009. Used with permission.
66
Case Study
Completion Process at Health Care for the
Homeless (HCH)

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
Long wait times,

clients low frustration
Client would need to
1. Client sees therapist Client leaves tolerance, psychotic
return to clinic as a
case manager before being symptoms, difficulty 5 3 5 75
walk-in and complete
(TCM) for first time seen by the TCM with navigating
process
check-in and
registration
TCM does not

2. Initial mental health
complete initial Client leaves during
assessment complet- Treatment interrupted 2 1 3 6
mental health session
ed
assessment
3. Schedule follow-up
TCM does not Schedule booked up,
appointment to begin Interrupts or delays
schedule follow- TCM forgets, client 1 1 5 5
psychosocial assess- treatment process
up appointment refuses
ment
Transportation, men-
Client does not tal health symptoms, Treatment interrupted
4. Client comes in for
come in for sec- finances, client goes and assessment is 6 1 9 54
second appointment
ond appointment to another source for not begun
treatment
TCM does not

5. TCM copies demo-
copy demo-
graphic data from
graphic data TCM interrupted and Form incomplete and
encounter sheet to 1 1 2 2
from encounter forgets chart data inaccurate
psychosocial intake
sheet to psy-
assessment sheet
chosocial sheet
Client did not show

6. Interviews client to up, TCM does not
TCM does not Assessment does not
gather data to com- have time to com- 8 5 9 360
gather data get completed
plete IPSE plete, other tasks
take priority
(continued)
67
Case Study
(HCH), continued
Step Failure Mode Causes Effects Occ. Det. Sev. RPN
Client crisis, TCM

7. If client needs ben-
schedule overbooked,
efits/insurance, TCM does not Client will not
client mental illness
TCM educates educate client receive benefits and 3 2 2 12
can interfere, lack of
client on the on the process resources
self-efficacy on the
process
part of the client
Referral source not

available, client might
Internal referral
8. If internal referral is refuse, TCM forgets Client would not
not given or
given, appointment to give referral, com- receive needed 2 8 1 16
appointment not
is put into database puter problems, TCM services
put into system
forgets to put into sys-
tem
9. If external referral is
Written informa- TCM forgets, client Client less likely to
given, written infor-
tion not given to crisis, not enough connect to referral 3 8 4 96
mation is given to
client time source
client
TCM overwhelmed by Client may discon-

10. TCM makes fol- TCM does not
client crisis, TCM for- nect from treatment,
low-up appoint- make follow-up 2 2 10 40
gets, client refuses, psychosocial not
ment appointment
client referred out completed
Assessment not
completed, client not
11. TCM provides TCM forgets, client
Diagnosis not properly assessed,
mental health crises take priority,
made, assess- takes longer to com-
diagnosis and clients illness 8 2 10 160
ment not complete assessment,
completes assess- impedes ability to pro-
pleted assessment not use-
ment vide information
ful as a treatment
tool
TCM is distracted and Assessment not

12. TCM signs TCM does not
forgets, assessment completed, out of 2 7 8 112
assessment sign assessment
not completed compliance
13. TCM files assess- Assessment missing

Assessment not Chart unavailable at
ment in assess- and possibly
filed or misfiled time of assessment, 4 2 9 72
ment section of assumed not com-
in chart TCM distracted
chart pleted
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
Almost always detected

1 Certain to detect 10 out of 10
immediately
3 High likelihood 7 out of 10 Likely to be detected
Moderate likelihood of
5 Moderate likelihood 5 out of 10
detection
7 Low likelihood 2 out of 10 Unlikely to be detected
Detection not possible at

9 Almost certain not to detect 0 out of 10
any point
10
Focusing on Severity and Probability attention. A team can also choose to calculate an RPN for each
A simple approach to rating is to focus on two factorsthe effect and then add the RPNs for each effect together to get an
severity (of the effect) and the probability (of the effect). overall criticality value for the failure mode. This is the most
Multiplying the severity of the effect by the probability of the rigorous approach to quantifying risk because it considers each
effect (based on historical data or estimates of frequency, irre- possible effect of each failure mode. This level of detail is pre-
spective of the possible cause) yields a number that indicates sented here to demonstrate the factors that might be consid-
the most critical effects (that is, those with the highest point ered. Table 4-6, page 70, illustrates the process. Failure Mode
value). The team can analyze the failure modes that were iden- 1 has two potential effects whose RPNs are 126 and 196.
tified as potentially causing these effects, as well as other fac- Adding these, Failure Mode 1 has a criticality value of 322.
tors, such as detectability, preventability, and controllability. Failure mode 3, which has the most severe potential effect (one
with a rating of 10) and one other possible effect, has a criti-
Risk Priority Number cality value of 195. The criticality values are used to establish a
Another commonly used method to calculate criticality is to priority ranking for further analysis of failure modes.
calculate a risk priority number (RPN), also called a criticality
index, based on severity, occurrence, and detection ratings. Reaching Consensus
The mathematical calculation is as follows: No matter what rating method and rating scale the team uses,
team members must reach consensus on the ratings assigned.
RPN = Severity Rating x Probability of occurrence rating x This may be challenging because of the different perspectives
Detectability Rating of individual team members. Robin E. McDermott and col-
Or, simplified, RPN = Severity x Occurrence x Detectability leagues recommend the following strategies for reaching con-
sensus4:
A team can choose to calculate an RPN for a failure mode as a Agree as a team on how disagreements will be handled.
whole. Failure modes with high RPNs automatically warrant Structure the process for resolving disagreements.
69
Table 4-6. Determining Risk and Criticality for Priority Ranking
Most critical failure mode
Failure
Effect Sev Prob Det RPN Crit Rank
mode
FM #1 Effect 1a 3 6 7 126
Effect 1b 7 4 7 196 322 1
FM #2 Effect 2a 3 3 2 18
Effect 2b 7 3 2 42 60 2
FM #3 Effect 3a 10 5 3 150
Effect 3b 3 5 3 45 195 2
Most severe effect
When there is disagreement on ratings, the individuals should transfer these numbers to the FMEA worksheet. At this
representing each viewpoint should present their ration- time, the team might choose to consider other factors associat-
ales for a specified and finite period of time. Team mem- ed with the failure mode, such as the cost of fixing it, timing,
bers can then cast their votes for the rating they would related performance or quality improvement initiatives, and
prefer. The leader then calculates the mean rating to deter- availability of resources.
mine a score that represents the average rating. The team
discusses the rating. Prioritizing Failure Modes
If one or more team members still do not agree on the rat- At this point, the team is ready to prioritize the failure modes.
ing, the team might want to invite a process expert who is Failure modes must be ranked to establish priorities for
not currently on the team to join the conversation and pro- actions. With limitless resources, teams could pursue root
vide additional information. This person should not pro- cause analysis (RCA) and improvement or redesign of each and
vide the ranking determination, but rather offer additional every failure mode. In reality, few organizations have the
information that the team might not otherwise have. resources to do this. Because RCA takes time, it makes sense to
Consider the failure modes or effects relative to each other prioritize the failure modes to make the most efficient use of
by placing the modes or effects in order from the highest the time spent by the team on proactive risk reduction. The
severity to the lowest severity. Then indicate the ratings for team must concentrate on those failure modes most likely to
each. result in adverse occurrences, thereby negatively affecting the
Avoid assigning a rating arbitrarily because this could safety of individuals served. These failure modes are ranked
result in a decision not to focus on the failure mode. high on the list of items requiring action because they involve
When the ratings are multiplied, a small point difference the greatest degree of risk.
can have a significant impact on the RPN. Talk out sticky
issues until they are resolved. Several tools can help the team prioritize failure modes. The
If resolution or consensus still cannot be reached, the team team should feel free to use whatever tool is most helpful to
might agree to bias the decision toward the safe side by achieving the objective, which is to identify those failure
assigning the higher rating. modes that are most in need of attention. For example, Pareto
charts illustrate the relative ranking of failure modes in a visu-
Once the FMEA team determines quantitative and/or qualita- al way. In other cases, simple numeric order rankings can pro-
tive values for each failure mode, based on such factors as vide all the help that is needed.
severity, probability of occurrence, and detectability, the team
70
Case Study
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 rst column served as a reminder of the order of the steps in the
overall process.
Risk Analysis
Order Process/Sub- Initial Status
Potential Failure Modes Failure Effects
Rank process/Activities
Sev. Occ.
Porter leaves order at the An emergency order is left There might be a delay in
4 9 9
Pharmacy for later treatment
Orders are controlled and The wrong medication is

Wrong medication might be
5 prepared by Pharmacy sent (dosage, route, name, 9 9
administered
staff formula)
Orders are controlled and

Drug-drug interaction con-
5 prepared by Pharmacy Side effects might occur 10 8
trol is not made
staff
Order is sent to Wrong medication might be

1 Mistake in the repeat order 9 8
chemotherapy nurse administered
Order is sent to chemother- Medication might be admin-

1 Mistake in the repeat order 9 8
apy nurse istered in the wrong dose
Nurse pulls out the original

and first copy of the order
Mistake in an urgent-emer-
2 from the file and the med- Treatment might be delayed 7 10
gency request
ication is put into the
request bag
Drug-food interaction con-

trols are not followed and
5 prepared by Pharmacy Side effects might occur 8 8
orange warning label is not
staff
attached

Medications are not Patient might be adminis-
5 prepared by Pharmacy 8 8
labeled tered wrong medication
staff

Medication label is not Wrong medication might be
attached to medication bag administered
staff
(continued)
71
Case Study
Risk Analysis
Order Process/Sub- Initial Status
Potential Failure Modes Failure Effects
Rank process/Activities
Sev. Occ.

Medication label is not Wrong medication might be
attached to medication bag administered
staff

Medication label is not Wrong dose might be adminis-
attached to medication bag tered
staff
Medication cabinets are Safety of the medication is an

10 Cabinet cannot be locked 8 8
locked issue

Adjust the dosage label is Wrong dose might be adminis-
not attached tered
staff
Porter leaves order at the An emergency order is left

4 Delay during patient discharge 7 9
Pharmacy for later
Porter leaves order at the Discharged patient baskets

4 Delay during patient discharge 7 9
Pharmacy are mixed up
Pharmacist controls and Label is forgotten (high-risk Medication goes out without a
3 7 9
prepares orders medication) label
The dosage amounts Mistake is made in calcula- Medication might be adminis-

2 9 7
requested are written out tions in adjusting dosage tered in the wrong dose
Nurse pulls out the origi-

nal and first copy of the Less medication than was
Colored pencil has not
2 order from the file and the requested might be sent or no 7 8
been used
medication is put into the medication is sent
request bag

Medication label is not Might be administered to
attached to medication bag wrong patient
staff
72
Case Study

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 identied. 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 pro- The safest rule of thumb when using RPNs is to focus on elim-
vide all the help that is needed. inating failure modes associated with severity rankings of 8 or
above and those with high RPNs. Keep in mind that RPN val-
Teams that have quantified the risks involved with particular ues are meaningful only in a comparative sense. They can be
failure modes using RPNs may choose a cutoff point to help compared only within one FMEA, not across multiple
with prioritization. Failure modes with scores below the cutoff FMEAs.
point do not need to be pursued unless time is available.
Failure modes with scores above the cutoff point must be References
explored. While this arbitrary cutoff point is helpful in paring 1. Spath P: Home study program: Using failure mode and effects
down the number of priorities, one risk of using this approach analysis to improve patient safety. AORN J 78:15-44, Jul. 2003.
is that important projects that dont make the cutoff are 2. Dodson B., Nolan D.: The Complete Guide to the CRE. Houston:
ignored and other projects that are less important make the Quality Publishing, 1996. http://www.qualityamerica.com/
cutoff because of the way the RPNs were calculated. For exam- knowledgecente/articles/fmea1.html (accessed Mar. 4, 2010).
ple, if a team established a cutoff point of 50, meaning that 3. Gryna (1988) as cited in Juran J.M., Juran G., Blanton A. (eds):
Jurans Quality Handbook, 5th ed. New York: McGraw-Hill, 1999,
failure modes with RPNs of less than 50 would not be the sub-
pgs. 1926.
ject of further focus, a failure mode with an RPN of 40 would
4. McDermott R.E., Mikulak R.J., Beauregard M.R.: The Basics of
be dropped from focus. Yet any failure mode with a high sever- FMEA, 2nd Edition. New York: Productivity Press, 2009.
ity ranking poses a possible threat to safety. These types of fail-
ure 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.
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.
73
74
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
Step 1
potential failure modes. Root causes are the most fundamental reasons
a problem could occur. Most root causes in and of themselves are not
assemble a team.
sufficient to cause a failure; rather, the combination of root causes sets
the stage for potential failure.
Step 2
Root cause analysis (RCA) is a process for identifying the basic causal Diagram the process.
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 Step 3
with health care processes and systems. An RCA focuses primarily on Brainstorm potential failure modes
systems and processes, not on an individuals performance. and determine their effects.
Using Root Cause Analysis
An RCA approach can be used prospectively to probe a failure mode
Step 4
or a combination of modes that could occur in the future. Through
Prioritize failure modes.
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. Step 5
Although a failure mode is the result of a potential unexpected varia- modes.
tion 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. Step 6
Common-cause variation, although inherent in every process, is a con-
sequence 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 Step 7
how busy the radiology service is or on when the report is requested. Analyze and test the new process.
On a particular day, there may be many concurrent requests for
reports, making it difficult for the radiology department to fill one spe-
cific request. Or the report may have been requested between mid- Step 8
night and 6 A.M. when fewer radiology technologists are on duty.
Implement and monitor the
Variation in the process of providing radiology reports is inherent,
redesigned process.
resulting from common causes such as staffing levels and work load. A
75
process that varies only because of common causes is said to be

stable. Common-cause variation is systemic and endoge- Tip: Effective Root Cause Analyses
nousthat is, produced from within. Common-cause failures (RCA)
occur as a result of the way a process itself is designed. There are several characteristics of an effective
Therefore, such failures can be prevented through redesign of RCA, including the following:
the process. Focuses primarily on systems and processes, not
on individual performance
Another type of variation, special-cause variation, arises from Progresses from special causes in clinical
unusual circumstances or events that may be difficult to antic- processes to common causes in organization
ipate and may result in marked variation and an unstable, processes
intermittent, and unpredictable process. Special-cause varia- Repeatedly digs deeper by asking why?; then,
tion is not inherently present in systems. It is exogenousthat when answered, asks why? again, and so on
is, produced from withoutand results from factors that are Identifies changes that could be made in systems
not part of the system as designed. Mechanical malfunction, and processeseither through redesign or
intoxicated employees, floods, earthquakes, and hurricanes are development of new systems or processesthat
examples of special causes that result in variation or failures. would reduce the likelihood of failure modes
Special causes should be identified and mitigated or eliminat- occurring
ed, if possible. However, removing a special cause will elimi- Is thorough and credible
nate only that current abnormal performance in the process. It
will not prevent the same special cause from recurring.
sent, in effect, latent conditions waiting to happen. The combi-
Special causes in one process are usually the result of common nation of root causes sets the stage for failure modes. Effective
causes in a larger system of which the process is a part. For identification of all the root causes and an understanding of
example, mechanical breakdown of a piece of equipment may their interaction can aid an organization in changing processes
indicate a problem with an organizations preventive mainte- to eliminate a whole family of risks or failure modesnot only
nance activities. Similarly, an intoxicated employee indicates a a single risk or mode.
problem with the organizations screening and hiring practices.
Human resources practices need to be examined for common- Conducting the Root Cause Analysis
cause problems involving personnel screening and interview FMEA teams conduct RCAs to determine why a failure mode
processes. What implications does this have for the FMEA identified by the team as a high-priority one for future atten-
under way within an organization? Because failure modes rep- tion could occur. The analysis involves asking a series of why
resent variation, FMEA teams should ask the question Is this questions that probe deeper and deeper to uncover root causes
failure mode the result of a common-cause variation or a spe- and their relationships. The basic structure of the questioning
cial-cause variation? Failure modes created by a common-cause process is as follows:
variation can be addressed (that is, eliminated or their likeli- What could happen? (the failure mode)
hood reduced) by redesigning the process. Failure modes creat- Why could this happen? That is, what are the most proxi-
ed by a special-cause variation require further analysis through mate causes? These typically involve special-cause varia-
prospective RCA to identify the process or system factors that, tions.
when redesigned, will reduce or eliminate this type of failure. Why could these proximate causes happen? That is, what
systems and processes underlie those proximate causes?
Identify All Root Causes Common-cause variation here may lead to special-cause
The identification of all root causes is essential to preventing a variation in dependent processes.
potential failure. Why? The interaction of the root causes is
likely to be at the root of what led to the problem. If an organ- Teams will note that these are the same questions asked in a ret-
ization eliminates one root cause only, it reduces the likelihood rospective RCA of a sentinel event, except that did is substi-
of that one very specific cause from occurring. But if the organ- tuted for could with retrospective analysis.
ization misses the other five root causes, it is possible that those
root causes could interact in a different way to cause a different Proximate causes are acts or omissions that naturally and direct-
but equally adverse outcome. The root causes collectively repre- ly could produce a consequence. They are the superficial, most
76
Chapter 5: Identifying Root Causes of Failure Modes
Case Study

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, difculties in getting compliance from the client, or a combination thereof.
apparent, or immediate possible reasons for an occurrence. In the health care environment, proximate causes tend to fall
When looking at the chain of possible causation, proximate or into a number of distinct categories beyond, and in addition
direct causes tend to be nearest to the origin of the possible to, process factors. These include human factors, equipment
failure mode. They generally can be gleaned by asking Why factors, controllable or uncontrollable environmental factors,
could the failure happen? and other factors. To identify the proximate cause of a failure
mode involving human factors, the team might ask, What
By contrast, possible root causes are systemic and appear far human factors are potentially relevant to the failure mode? To
from the origin of the potential failure, often at the foundation identify the proximate cause of a failure involving equipment
of the processes involved in the event. For example, possible factors, the team might ask, How does the equipment per-
root causes of a potential medication error might include com- formance potentially affect the failure mode? To identify the
munication problems, staff training, look-alike drug labels, proximate cause of a failure mode involving environmental
ineffective pharmacy recall processes, and so on. Drilling even factors, the team might ask, What environmental factors
deeper, a team might determine that possible root causes of a potentially directly affect the failure mode? and Are such fac-
potential medication error include inefficient information tors within or truly beyond the organizations control? Finally,
technology systems or inadequate resource allocation for staff
education.
In most cases, identifying the possible proximate causes will be Tip: Example Proximate Causes
simple; in other cases, it might take some brainstorming. For Preventing Suicide
example, in exploring possible causes of potential adverse In identifying the proximate causes for a suicide, a
occurrences related to falls, proximate causes could include team might conclude that proximate causes could
failure to monitor individual, bed alarm not working, call include the following:
light not working, individual is not properly oriented to use Human factors involving failure to follow policies
of call light, incorrect sedation dispensed, or incorrect on precaution orders or failure to conduct
administration of sedation. Characteristics of proximate caus- appropriate staff education/training
es include the following: Assessment process factors involving a faulty
Readily apparent initial assessment process that does not include
Appear to be most immediate reasons for a possible occur- identifying a past history of suicide attempts or an
rence immediate psychiatric consultation
Lay closest to the origin of the possible failure mode Equipment factors involving a nonfunctional paging
Typically involve a special-cause variation system that delays communication with the
Often involve human error or equipment malfunction individuals physician
77
ble at this stage because of the tendency to stop short after

Tip: Possible Questions to Uncover identifying proximate causes and not probe any deeper. The
Causes probing must continue until a reason underlying a cause can
To help uncover the reasons behind a particular no longer be identified. Again, in most cases, a special cause of
failure mode, a team might want to start with the variation in one process is often found to be the result of, or
following questions: permitted by, a common cause of variation in a larger system
What safeguards are missing in the process? of which the process is a part. Identifying a special cause is only
If the process already contains safeguards (for an initial step in a full evaluation.
example, double checks), why might they not work
to prevent the failure every time? Looking at Functions or Processes
What would have to go wrong for a failure like this Listing and categorizing the possible causal factors represents
to happen? one way to determine what systems are involved with a poten-
If this failure occurred, why would the problem not tial failure mode. Root causes of a failure mode in health care
be identified before it affected an individual? can be categorized according to the important organization
functions or processes that the organization performs. These
can include processes for the following:
the team might ask, Are there any other factors that could Leadershipembracing a culture of safety, supporting
directly influence this failure mode? performance and quality improvement, and clear commu-
nication of priorities
Probing for Root Causes Human resources
The FMEA team is now ready to identify the root causes of a Information management
possible failure mode. This represents a deeper level of digging Environmental and equipment management
to determine the systemic roots of a potential problem. At this
point, the team has a detailed list of proximate causes that In addition, factors beyond an organizations control should be
describe the care processes and other factors that might con- considered as a separate category. Teams need to exercise cau-
tribute to a failure. The team again asks why?: Why could tion in assigning factors to this category, however. Although a
this proximate cause happen? What systems and processes causative factor may be beyond an organizations control, the
could underlie proximate and other contributing factors? The protection of care recipients from the effects of the uncontrol-
goal of asking questions at this stage is to identify possible lable factor is within the organizations control in most cases
underlying causes for the proximate causes. More questions and should be addressed as a risk-reduction strategy.
the team can ask in the effort to uncover causes include the fol-
lowing: Concrete questions about each function mentioned here can
What safeguards are missing in the process? help teams reach the essence of the problemthe systems that
If the process already contains safeguards (for example, lie behind or underneath problematic processes. At this stage,
double checks), why might they not work to prevent the questions can be worded in the form To what degree is ?
failure every time? Follow-up questions for each could be Can this be improved
What would have to go wrong for a failure like this to and, if so, how? and What are the pros and cons of expend-
happen? ing the necessary resources to improve this? See Sidebar 5-1,
If this failure occurred, why would the problem not be page 79, for a list of possible questions. While this list repre-
identified before it affected the individual receiving care? sents a start to the process, other questions may emerge in the
Is this failure more likely to occur at a specific location or course of an analysis. All questions should be fully considered.
time? Sidebar 5-2, page 81, provides a handy checklist to ensure that
Are particular personnel more likely to experience this the team has considered selected system-based issues.
failure?
The teams list of possible causal factors may be lengthy.
As in all other stages of the process, it is critical for the team to Regardless of its length or the technique used, the team should
focus on probing for system or common-cause problems, consider analyzing each possible cause or factor one at a time.
rather than on human errors. Teams can sometimes have trou- Asking the following two questions will help to clarify whether
78
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 can orientation and in-service training be improved? What are the pros and cons of expending the neces-
sary 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 avail-
ability and access? To what degree is the information accurate and complete? To what degree is the informa-
tion 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,
79
each cause listed is actually a potential true root cause:

1.If we fix this cause, could the failure mode occur in the Tip: Possible Characteristics of Root
future? Causes
2.If this cause is a root cause, does it help explain the possi- Root causes are systemic.
ble failure mode? (Note that if the failure mode were the Root causes appear far from the origin of the
result of a combination of root causes, no one root cause failure.
alone would fully explain the failure mode.) The origins of root causes lie in common-cause
If the answers are yes, then the problem is a root cause. variation of organization systems
It is highly likely that the team will identify more than one
root cause for a possible failure mode. It is important to ask care that are available organizationwide and in the profession-
how the possible root causes are related. Would the potential al literature.
failure mode occur if each possible cause were not present?
Another way to gain information about a process is to look at
If the team identifies more than six root causes, a number of performance measurement data related to that process.
the causes may be defined too specifically. In this case, the Measurement data can provide a baseline when little objective
team might want to review whether one or more of the root evidence exists about a process. For example, a health care
causes could logically be combined with another to reflect organization may want to learn more about the current level of
more basic, system-oriented causes. staff competence. A dementia long term care or psychiatric
special care unit might want to know more about the effective-
The team should verify each of the remaining potential root ness of the bed alarm systems to prevent falls and elopement.
causes. This involves cross-checking for accuracy and consis- Specific indicators for a particular outcome or a particular step
tency all facts and all tools and techniques used to analyze in a process may be used for ongoing data collection. Once
information. Any inconsistencies and discrepancies should be assessed, these data can help the FMEA team determine
resolved. whether a process is ineffective and needs more intensive
analysis. Data about costs, including costs of faulty or ineffec-
How does a team know whether and when it has identified all tive processes, may also be of significant interest to leaders and
the potential root causes of a possible failure mode? Teams can be part of ongoing performance measurement. For more
should resist the temptation to stop drilling down too soon. on effective data collection, see Sidebar 5-4, page 82.
However, if potential root causes fully explain from all points
of view why the failure mode would occur, and the potential Data from performance measurement activities can also be
root causes are logical, make sense, and dispel all confusion, used to gain more information about a process chosen for
then it is likely that the team has analyzed that possible failure assessment and improvement. For example, perhaps a per-
mode fully and correctly. formance rate varies significantly from the previous year, from
shift to shift, or from the statistical average. A team may be
Resources for Root Cause Analysis measuring staff compliance with the organizations restraint
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 Tip: Definition of Measure
brought to the table by current FMEA team members provides An indicator, or measure, is all of the following:
one place to start. The team can turn to individuals who have Quantitative. It is expressed in units of measure-
process expertise but who are not currently on the team to gain ment.
additional insight. Other organizational staff and the care Valid. It identifies events that merit review.
recipient and their families can provide valuable input into the Reliable. It accurately and completely identifies
RCA process. Interviews and surveys can be used to obtain occurrences.
information from such individuals (see Sidebar 5-3, page 82). A measure of a process or outcome. It involves a
Review of the organizations policies and procedures related to goal-directed series of activities or the results of
the process under study can also provide valuable information performance.
for the RCA process, as can review of professional standards of
80
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 Competence of physicians
Corrective actions identified and implemented Initially verified
Risk-reduction initiatives receive priority attention Reviewed and verified on regular basis
Barriers to communication of risks and errors Competence of agency staff
Communication Initially verified
Present, as appropriate Reviewed and verified on regular basis
Appropriate method Supervision of staff
Understood Adequate for new employees
Timely Adequate for high-risk activities
Adequate Current staffing levels
Managerial controls and policies Based on reasonable individual acuity measure
Appropriate controls and policies in place Based on reasonable work loads
Policies enforced Current scheduling practices
Communication regarding policy changes Overtime expectations
Time for work activities
Human Resources Issues Time between shifts for shift changes
Qualifications of staff
Defined Information Management Issues
Verified Availability of information
Reviewed and updated on regular basis Accuracy of information
Qualifications of physicians Thoroughness of information
Defined Clarity of information
Verified Communication of information between relevant indi-
Reviewed and updated on regular basis viduals/participants
Qualifications of agency staff
Defined Environmental Management Issues
Verified Physical environment
Reviewed and updated on regular basis Appropriateness to processes being carried out
Training of staff Lighting
Adequacy of training program content Temperature control
Receipt of necessary training Noise control
Competence/proficiency testing following training Size/design of space
Training of physicians Exposure to infection risks
Adequacy of training program content Cleanliness
Receipt of necessary training Systems to identify environmental risks
Competence/proficiency testing following training Quality control activities
Training of agency staff Adequacy of procedures and techniques
Adequacy of training program content Inspections
Receipt of necessary training Planned, tested, and implemented emergency and failure
Competence/proficiency testing following training mode responses
Competence of staff
Initially verified
Reviewed and verified on regular basis
81
Sidebar 5-3. Tips for Successful Interviews Sidebar 5-4. Criteria for Data Collection
Open the interview by stating the focus and purpose Choosing what to measure is critical. So is ensuring that
of the interview. Reiterate that information obtained the data collected are appropriate to the desired meas-
will be used to help improve processes in order to urement. This checklist includes criteria to help the
enhance safety. team ensure that the data collected are appropriate for
Pose open-ended questions, which elicit more than monitoring performance.
just a yes or no response. Start with an exploratory
question, such as What can you tell me about X? The measure can identify the events it was intend-
and follow up by asking a question such as Why? or ed to identify.
What do you mean by Y? or Can you tell me more The measure has a documented numerator and has
about X? a denominator statement or description of the
population to which the measure is applicable.
Listen well and avoid interrupting the interviewee.
Ask questions with a purpose. Avoid being talkative.
The measure has defined data elements and allow-
able values.
Summarize throughout the interview to ensure a
The measure can detect changes in performance
proper understanding of what the interviewee related.
over time.
Be aware of body language and other nonverbal cues.
The measure allows for comparison over time
Before closing the interview, ask if the interviewee has within the organization or between the organiza-
any questions or concerns, summarize the whole tion and other entities.
interview, and thank the interviewee, expressing The data intended for collection are available.
appreciation for the individuals time, honesty, and Results can be reported in a way that is useful to
assistance. the organization and other interested customers.
policy, for instance. Records may indicate that the staff on duty of tools can be found in Table 5-1 on page 84. The following
during weekend hours did not properly document the monitor- is a discussion of some of these tools and their applicability to
ing of individuals in restraint or obtain appropriate orders for the FMEA process.
restraint use. Or, perhaps the data indicate that restraints are
used with an increased frequency when specific personnel are Brainstorming
present. Perhaps monitoring problems or inappropriate restraint Brainstorming can help identify all potential contributing
use is suspected as a part of a root cause of a failure mode. Such causes to a potential failure. Following the traditional brain-
findings may reveal problematic trends and help an FMEA team storming ground rules (see Chapter 3), such as There is no
identify possible causal factors for failure. bad idea, is necessary in order to generate well-thought-out
and probable causes to issues.
Successful measurement requires indicators that are stable,
consistent, understandable, easy to use, and reliable. Affinity Diagram
Indicators, or performance measures, are devices or tools for An affinity diagram can be used to help identify proximate
quantifying the level of performance that actually occurs. They causes, root causes, and improvement opportunities. As men-
are valid if they identify events that merit review, and they are tioned in Chapter 3, this tool allows teams to organize a large
reliable if they accurately and completely identify occurrences. volume of ideas into meaningful groups. Once the team has
brainstormed and recorded ideas about a process, the team
Tools to Help with Root Cause Analysis facilitator can randomly display index cards or adhesive notes
A team can use a variety of tools to help ensure a thorough with the ideas so that everyone can see them.
RCA. Some of these same tools can be used to help implement
and measure the effectiveness of proposed actions. A matrix list Team members then sort the ideas into groups of related top-
ics and create header or title cards for each grouping. Ideas
82
Case Study
Conducting FMEA on the Opioid Prescribing Process at the
University of Texas M.D. Anderson Cancer Center
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 It is important to gather data to determine the relative frequen-
their gut instinct. If an idea keeps getting moved back and cies of the causes. The team should look for causes that appear
forth from one group to another, the team should agree to cre- continually in the evaluation process. It should place the out-
ate a duplicate card or note. The team may need to allow for comes on the right side of the page, halfway down, and then,
some ideas to stand alone. It may be helpful to break large from the left, draw an arrow horizontally across the page,
groupings into subgroups with subtitles, but be careful not to pointing to the outcome. Everyone should agree on the prob-
slow progress with too much definition. Once the team reach- lem statement or outcome, which should be succinct.
es consensus on the groupings and headers, connect all header
cards with their groupings then draw the affinity diagram. An Change Analysis
example of an affinity diagram can be seen in Figure 5-1, page This tool can be used to help identify proximate causes and
85. root causes by examining effects of change. This involves iden-
tifying all perceived changes and all the possible factors related
Cause-and-Effect Diagrams to the changes. To conduct a change analysis on a particular
Cause-and-effect, or fishbone, diagrams can help present a process, the team must first describe the process as it should
clear picture of the many causal relationships between out- occur, in as much detail as possible. Include the who, what,
comes and the contributing factors to those outcomes. They when, where, and how information of the process. Then
can also highlight which process steps and linkages could be describe how the process actually occurs and compare the two,
involved in a failure. To create a cause-and-effect diagram, a trying to detect any differences. List all the differences and
team should determine general categories for possible causes of analyze them. Carefully assess the differences and identify pos-
a failure mode. It should represent common categories, includ- sible underlying causes. Describe how these affect the process.
ing work methods, personnel, materials, and equipment, on Did each difference or change explain the result? Integrate
the diagram by connecting them with diagonal lines branching information and specify root cause(s). Identify the cause that,
off from the main horizontal line. The team should then list if eliminated, would have led to a perfectly conducted process.
proximate causes under each general category and list underly- Remember that not all changes create problems; rather, change
ing causes related to each proximate cause. Figures 5-2 and 5- can be viewed as a force that can either positively or negative-
3, pages 86-87 offer examples of this tool. ly affect the way a system, a process, or an individual functions.
83
Table 5-1.
Checklist: Problematic Systems or Processes
Identifying Implementing and

Tools Proximate Root Improvements Monitoring
Improvements
Affinity diagram x x x
Barrier analysis x x
Box plot x
Brainstorming x x
Cause-and-effect diagram x x
Change analysis x x
Checksheets x x
Contingency diagram x x x
Control charts x x x
Cost-of-quality analysis x
Critical-to-quality analysis x
Decision matrix x x
Deployment flowchart x x x
Effective-achievable matrix x x
Failure mode and effects analysis x
Fault-tree analysis x x x
Fishbone diagram x x
Flowchart x x x x
Force field analysis x x x
Gantt chart x x x x
Graphs x x
Histogram x x x x
Ishikawa diagram x x
IsIs not matrix x
Kolmogorov-Smirnov test x x
List reduction x x
Matrix diagram x x x
Multivoting x x x
Nominal group technique x x
Normal probability plot x x
Operational definitions x x x
Pareto chart x x
PDSA (plan-do-study-act) cycle x
PMI (plus, minus, interesting) x x
Relations diagram x x x
Run chart x x x
Scatter diagram (scattergram) x x
Storyboard x x
Stratification x
Time line x x
Top-down flowchart x x x
Why-why diagram x
Work-flow diagram x x x
This matrix lists many of the tools and techniques available during root cause analysis and indi-
cates the stages during which they may be particularly helpful. Not all of the tools are profiled in
this chapter.
84
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 dia-
gram 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 work- the variability of a data set. The team then sets upper and
sheet. lower control limits. Control limits should be three times
higher or lower than the standard deviation, relative to the
Control Charts mean. In creating the control chart, plot the mean (that is,
A control chart can illustrate whether a variation in a process center line) and the upper and lower control limits. Plot the
is statistically in control. It can help identify root causes and data points for each point in time and connect them with a
opportunities for improvement. It can also help implement line. In plotting data points, keep the data in the same
and monitor improvements. Control charts are created by cal- sequence in which they were collected. In a control chart, spe-
culating an average of specific data related to a process, such as cial-cause variation appears as points outside the control lim-
the number of residents who experience a fall per month. The its. In contrast, common-cause variation appears as points
team then calculates the standard deviationthe measure of between the control limits. Be aware that special causes of vari-
85
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 eventthe 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.
86
Figure 5-3
Example Cause and Effect Diagram:
Improving Diabetes Screening
People Policy
Potential Failures: Potential Failures:
- Patient not asked if they - Patient diabetic status not
have diabetes at time of confirmed at time of consent
scheduling
Potential Causes:
Potential Causes: - No policy regarding diabetic
- No reminder or question in patient care before interven-
procedure scheduling form tional procedure
Potential Solutions: Potential Solutions:

- Develop specific question in - Make staff aware of policy
the procedure scheduling - Add question to consent
form form, diabetic instructions,
and request form
- Document diabetic status
Improved screening for

diabetes before inter-
ventional procedures
Supply Equipment
Potential Failures: Potential Failures:
- No blood glucose monitoring - Code cart and monitoring
device available equipment not available
Potential Causes: Potential Causes:

- No standard location identi- - No standard location identi-
fied for supplies fied for code cart and moni-
toring equipment
Potential Solutions:
- Develop daily checklist of Potential Solutions:
intervention room supplies - Identify standard location for
- Document daily checklist code cart and monitoring
- Identify standard location for equipment
supplies - 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 252:544550, Aug. 2009. Used with
permission.
87
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 fundamen- may be in control but consistently poor in terms of quality and
tally improved and before the control chart can be used as a the reverse may also be true. While control charts can be help-
monitoring tool. The following four rules for identifying an ful, charting something accomplishes nothing; it must be fol-
out-of-control process include: lowed by investigation and appropriate action. Examples of
1. One point on the chart is beyond three standard devia- control chart patterns can be seen in Figure 5-5, page 89.
tions of the mean.
2. Two of three consecutive data points are on the same side Fault-Tree or Event-Tree Analysis
of the mean and are beyond two standard devtions of the Fault-tree analysis, or a tree diagram, is a graphical, deductive
mean. tool for systematically listing various sequential or parallel
3. Four of five consecutive data points are on the same side events or combinations of faults that must occur for a particu-
of the mean and are beyond one standard deviation of the lar undesired event to occur. A fault-tree diagram resembles a
mean. logic diagram or flowchart.2 Fault-tree analysis, or a tree dia-
4. Seven consecutive data points are on one side of the gram, can be used to help consider multiple, interacting fail-
mean. ures. It can also help identify proximate causes, root causes,
and opportunities for improvement. The following six steps
The terms in control and out of control do not signify whether are involved in fault-tree analysis:
a process meets the desired level of performance. A process 1. Define the top event of interest.
88
Figure 5-5
Patterns in Control Charts
These two control charts illustrate different patterns of performance an organization is likely to encounter. When perform-
ance 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.
89
Case Study
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 identied. 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
elds in the lab orders were printing differently in the lab than they looked on the screen.
When the root causes were identied, 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
1A. Unable to
1. Physician writes
read Physician handwriting illegible 3 1 10 30
order
orders
Assumption that other orders

1B. Previous
are automatically discontinued
order not
Example: Assuming that admit 9 9 7 567
discontin-
labs would discontinue after
ued
writing new labs.
1C. Duplication Physician overlooks previous

4 9 7 252
of orders orders
1D. Write order

for wrong Mix up with multiple births 2 9 10 180
baby
2. Physician returns 2A. Chart not Chart overlooked in

3 8 8 192
chart to desk collected collection
2B. Chart not New resident places chart in

3 8 8 192
returned wrong place
3. Help unit coordi-

nator (HUC) 3A. Order not Overlooked among multiple line
9 10 10 900
enters order into entered items
computer system
(continued)
90
Case Study
Laboratory Test Ordering Process at Miami Valley Hospital,
continued
Process
Failure Mode Cause(s) of Failure Occ. Det. Sev. RPN
Component
3B. Wrong lab entered Human error 5 8 10 400
Misinterpret orderunclear
5 7 9 315
order for nonroutine lab
3C. Enter order for

Human error 2 8 10 160
wrong day
3D. Enter order for

Mix up with multiple births 1 7 10 70
wrong baby
3E. Order not entered Computer system functionality

as written by physi- issueexample: Date/Time 4 2 8 64
cian mismatch
Computer system functionality

3F. Lab order not issuemultiple steps and mul-
5 3 7 105
customized tiple screens make it difficult to
customize the orders
3G. Orders entered dif- No standardization of routine

ferent ways by dif- HUC procedures for entering 10 9 9 810
ferent HUCs orders
3H. Multitasking and NICU environment and work

10 1 10 100
distractions load
4. HUC signs
paper order
4A. Paper record not in Paper record placed in wrong
and places 2 8 7 112
chart chart
chart in out
rack
Order sheet left in fax machine 2 2 5 20
91
Case Study
Conducting FMEA on Medication Requests at Amerikan
Hastanesi, Istanbul, Turkey
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 identied.
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 rst column
serves as a reminder of the order of the steps in the overall process.
Order Rank Process Step Prioritized Failure Modes Main Causes
Mix-up of concepts of Emergency and

Porter leaves order
4 An emergency order is left for later. Urgent.
at the Pharmacy.
Non-detection of state of emergency.
Confusion in division of labor

Heavy telephone traffic
Divisions stemming from technicians
training
Carrying out all procedures at the same
Orders are con-
desk
trolled and pre- Wrong medication is given (dosage,
5 Narcotics not being requested promptly
pared by mode, name, formula)
Magistral medications not being
Pharmacy staff
requested promptly
Illegible order
Placing returned medication on wrong
shelf
Incomplete writing out of order
Orders are con-

trolled and pre- Drug-drug interaction check is not Leaving implementation for later
5
pared by pharmacy made System is not clearly known
staff
2. Construct the fault tree for the top event. List the major 6. Modify the diagram, as necessary. Retest the modified
contributory factors under the top event as thefirst-level diagram.
branches. Generally, the contributory factors can be
grouped under such headings as Personnel, Material or An example of a fault-tree analysis diagram can be found in
Equipment, Procedures/Processes, and so on. Figure 5-6, page 93.
3. Continue the branching process by adding another level
to the tree. These are the factors that might have account- Histogram
ed for the first-level branches. A histogram is used to help identify proximate causes, root
4. Add additional levels of branching, as necessary. causes, and opportunities for improvement, as well as for
5. Validate the tree diagram. Review the visualized events for implementing and monitoring improvements. It provides a
accuracy and completeness. snapshot of the way data are distributed within a range of val-
92
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
Radiation Therapy System. Jt Comm J Qual and Patient Safe 30(12):694, Dec. 2004.
93
Figure 5-7
Example Histogram
This example histogram was developed to analyze the turnaround time for authen-
ticating verbal orders from physicians. The irregular distribution suggests opportu-
nities for improvement.
ues and the amount of variation within a given process, sug- classes on the horizontal axis and the frequency on the
gesting where to focus improvement efforts. To create a his- vertical axis.
togram, teams can take the following eight steps: 7. Count the data points in each class and create the bars.
1. Obtain the data sets and count the number of data 8. Analyze the findings. Remember that some processes are
points. Data should be variable (that is, measured on a naturally skewed; do not expect a normal pattern every
continuous scale, such as temperature, time, weight, or time; however, large variability or skewed distribution
speed). Make sure data are representative of typical and may signal that the process requires further attention.
current conditions. The more data points you have, the
more meaningful the patterns. An example histogram can be seen in Figure 5-7, above.
2. Determine the range for the entire data set.
3. Set the number of classes into which the data will be Multivoting
divided. Be sure that the classes are mutually exclusive so Multivoting can be used to identify proximate causes, root
that each data point will fit into only one class. Using 10 causes, and opportunities for improvement. It is helpful when
class intervals makes for easier mental calculations. the team is trying to narrow down a broad list of ideas (that is,
4. Determine the class width (by dividing the range by the more than 10) to those that are most important and worthy of
number of classes). immediate attention. This involves reaching team consensus
5. Establish class boundaries. about a list frequently generated by brainstorming. The follow-
6. To construct the histogram, place the values for the ing eight steps are involved in the multivoting process:
94
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 launder-
ing process.
1. Combine any items on a brainstorming or other list that Pareto Charts

are the same or similar. Ensure that when combining Pareto charts can help visualize causes of a problem by display-
ideas on the lists, the team members who suggested the ing data comparatively. Pareto charts can be used to help iden-
ideas agree with the new wording. Clearly define each tify root causes and opportunities for improvement. They
idea so that everyone voting easily understands it. show which events or causes are most frequent and therefore
2. Assign letters to items on the new list. Use letters rather have the greatest effect. This enables a team to determine what
than numbers to identify each statement so that the vot- problems to solve and in what order. The following eight steps
ing process does not confuse team members. are involved in creating a Pareto chart:
3. Determine the number of points that will be assigned to 1. Decide on a topic of study. The topic can be any outcome
the list by each group member. Each member will use a for which a number of potential causes have been identi-
predetermined number of points (typically between 5 and fied. If the team is working from a cause-and-effect dia-
10) to vote on the different items on the list. gram, the topic will be the effect that has been targeted for
4. Allow time for group members to assign points independ- improvement.1
ently. 2. Select causes or conditions to be compared. Identify the fac-
5. Indicate each members point allocation on the list. tors that contribute to the outcomethe more specific,
6. Tally the votes. the better. When selecting factors for comparison, beware
7. Note the items with the greatest number of points. of grouping several distinct problems together, which can
8. Choose the final group or multivote again. skew the rank order. Refer to the cause-and-effect dia-
gram, and use the most specific causes and factors possi-
Figure 5-8, page 96, shows an example of multivoting results. ble.
3. Set the standard for comparison. In many cases, this will be
frequency, although factors may be compared based on
their cost or quantity.
95
Figure 5-9
Example Pareto Chart
This Pareto chart was used to rank the frequency of responses of selected root causes pro-
vided by team members investigating a sentinel event involving a wrong-site surgery.
96
Case Study
Conducting FMEA to Prevent Pressure Ulcers at
Gaylord Hospital
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, certied 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 couldnt 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 hospitals computerized documentation system didnt allow users to consider skin as an organ
with potential for decline (Cause #3, above). Therefore, the patient evaluation processes didnt include the cues that
would remind caregivers to consider skin breakdown.
4. Collect data. Determine how often each factor occurs (or A run chart can help identify proximate causes and root caus-
the cost or quantity of each, as appropriate). Use a check- es, as well as implement and monitor improvements. It is
list to help with this task. designed to reflect trends and patterns in a process over a spe-
5. Make the comparison. Based on the data collected in step cific period of time so that teams can identify areas that require
4, compare the factors and rank them from most to least. or are experiencing improvement. The following six steps are
6. Draw the charts vertical axis. On the left side of the chart, involved in creating a run chart:
draw a vertical line and mark the standard of measure- 1. Decide what the chart will measure (that is, what data
ment in increments. On the right axis, mark the cumula- will be collected over what period of time).
tive percentage. 2. Draw the graphs axes. Clearly mark all units of measure-
7. List factors along the horizontal axis. Factors should be ment on the chart. The x-axis should indicate time or
arranged in descending order, with the highest-ranking sequence; the y-axis should indicate what is being stud-
factor at the far left. ied. Make sure that the time period for data display is
8. Draw a bar for each factor. The bars represent how often long enough to show a trend.
each factor occurs, the cost of each factor, or its quantity, 3. Plot the data points and connect them with a line. Use at
as applicable. Include additional features, if desired. By least enough data points to ensure detection of meaning-
making a few simple additions to the chart, a team can ful patterns or trends.
show the cumulative frequency, cost, or quantity of the 4. Plot the center line (that is, the overall average of all
categories, in percentages. measurements). Indicate significant changes or events by
drawing dashed lines through the chart at the appropriate
An example Pareto chart can be found in Figure 5-9, page 96. points on the x-axis.
Run Chart 5. Evaluate the chart to identify meaningful trends. Do not
97
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 ues increase while moving up and to the right of each axis.
chart (that is, wild points); instead, focus on vital changes 4 Plot the variables on the graph. If a value is repeated, circle
in the process. Be aware that a run of six or more points that point as many times as necessary.
on one side of the average indicates an important event or 5. Interpret the completed diagram. The more the clusters
change. form a straight line (which could be diagonal), the stronger
6. Investigate the findings. the relationship between the two variables. If points cluster
in an area running from lower left to upper right, the two
A run chart example can be seen in Figure 5-10, above. variables have a positive correlation. This means that an
increase in y may depend on an increase in x; if you can
Scatter Diagram control x, you have a good chance of controlling y. If points
This tool, also called a scattergram, can be used to help identify cluster from upper left to lower right, the variables have a
root causes, as well as implement and monitor improvements. It negative correlation. This means that as x increases y may
is designed to display the correlationnot necessarily the cause- decrease. If points are scattered all over the diagram, these
and-effect relationshipbetween two variables. The following variables may not have any correlation (the effect, y, may be
five steps are involved: dependent on a variable other than x). Remember that if
1. Decide which two variables will be tested. Select two vari- the diagram indicates a relationship, it is not necessarily a
ables with a suspected relationship (for example, delays in cause-and-effect relationship. Be aware that even if the data
processing tests and total volume of tests to be processed). do not appear to have a relationship, they may be related.
2. Collect and record relevant data. Gather 50 to 100 paired Although scatter diagrams cannot prove a causal relation-
samples of data involving each of the variables and record ship between two variables, they can offer persuasive evi-
them on a data sheet. dence.
3. Draw the horizontal and vertical axes. Use the horizontal
(x) axis for the variable you suspect is the cause and the ver- For an example of a scatter diagram, see Figure 5-11, page 99.
tical (y) axis for the effect. Construct the graph so that val-
98
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 and ask Why again at the next level of the RCA process.
While not all failures will need a complete RCA, every failure
Not every failure mode requires a full RCA. Teams may want
should be studied, and an RCA should be done when necessary.
to cease the RCA questioning process for the following two
Team members may find the same or similar root causes for
reasons:
more than one potential failure mode.1 This should be consid-
1. At the end of the questioning process, it is clear to the
ered when redesigning the process, as discussed in Chapter 6.
team that nothing can be done to solve the root problems
because they are not in the organizations 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.
If the team cannot think of a way to prevent a failure mode at

one stage of the questioning process, it should probe further
99
References
2. Spath P.: Worst practices used in conducting FMEA projects. Hosp
Peer Rev 29:114116, Aug. 2004.
100
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.
Step 1
assemble a team.
When the FMEA team has successfully identified root causes of poten-
tial failure modes and the interaction of causes that are likely to be
problematic, the redesign of the process and its support systems are
Step 2
meant to reduce the risk of occurrence of the potentially problematic
failure modes and their interactions that could cause harm to individ-
uals.
Preparing to Redesign Step 3

Some preliminary work can help teams make the most efficient use of Brainstorm potential failure modes
their time during the redesign stage. One strategy that sets the stage for and determine their effects.
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 Step 4
take a deep breath and concentrate on the task at hand. This requires Prioritize failure modes.
providing the time and space to do so.
Much time can be saved during the redesign process by learning about
Step 5
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-spe-
modes.
cific information. As previously mentioned, professional associations
and organizations focused on safety can provide a wealth of valuable
information. Step 6
Such information can be used to validate the FMEA process steps con-
ducted 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 Step 7
must be committed to not reinventing the wheel. Obtaining informa- Analyze and test the new process.
tion 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. Step 8
redesigned process.
101
The third level of design or redesign focuses on mitigating the

Preparing to Redesign effects of errors that reach the individual receiving care. For
Focus on the most critical elements. example, antidotes and resuscitation equipment would be
Conduct a literature search to gather relevant available to mitigate the effects of transfusion failure. These
information from the professional literature. would effectively reduce the severity of the failures effects.
Network with colleagues.
Each redesign strategy focuses on a different element of the
criticality index described in Chapter 4. The first strategy
Redesign Strategies decreases the probability of the failures occurrence. The sec-
Risk-reduction strategies must emphasize systems rather than ond strategy increases the failures detectability. The third strat-
an individual human approach. If errors are made, if deficien- egy decreases the severity of the failures effects.
cies are discovered, individuals at each stage must revisit previ-
ous decisions and redesign or reorganize the process. Different Methods for Redesign
To redesign processes effectively to prevent harm, FMEA
There are three levels of designing or redesigning for safety. teams need to directly address the characteristics of high-risk
The first level involves designing or redesigning the process to processes, as described in Chapter 2. The goal is to reduce an
eliminate or reduce the occurrence, whenever possible, the aspect of the process that elevates its risk. Redesign approach-
opportunity for failure. This requires team members to start es should directly address the following:
with the assumption that failures will happen and design or Decreasing variability
redesign accordingly. Standardizing processes
Simplifying processes
The second level of redesign recognizes that even with good Optimizing redundancy
preventive design or redesign, failures will occur. Safeguards Using technology to automate
should be built in to prevent the failure from reaching the care Creating fail-safe designs
recipient. This means that redesign efforts should focus on Documentation
increasing the detectability of the failure so that when the fail- Reducing coupling
ure occurs, someone or something recognizes it, sounds an Providing comprehensive education
alarm, and interrupts the process, allowing the failure to be Establishing a culture of teamwork
corrected without an adverse result.1 Design or redesign efforts
should protect the person receiving care from possible failures. Decreasing Variability
For example, a computerized medication order entry system Although health care organizations do not have a lot of control
may identify an unusual dose (perhaps the result of a mis- over variability of the care recipient, there are strategies that
placed decimal point), provide immediate online feedback to address this risk factor. One strategy involves developing and
the ordering practitioner, and accept a corrected order, all implementing criteria for the selection of appropriate candi-
before the person receives the first dose. This represents a dates for elective procedures. Other strategies are to develop
design that includes a means for recognizing an antecedent and implement pretreatment preparation for high-risk care
error, communicating the fact of the error, and modifying recipients, manage comorbidities, and match level of care (for
(temporarily halting) the process to deal with the error while example, intensive care units versus regular medical/surgical
protecting against an adverse outcome.1 units) to risk status.
Standardizing Processes
Redesign Strategies Standardization can reduce the variability of process imple-
Prevent the failure from happening (decrease mentation and the unneeded variety of factors that can lead to
likelihood of occurrence). failures. In other words, standardizing a process can make it
Prevent the failure from reaching person (increase easier for people to do the right thing and harder for them to
the probability of detection). make mistakes. Standardizing drug doses and administration
Protect the person if a failure occurs (decrease the times and limiting unneeded variety in drugs, equipment, sup-
severity of the effects; mitigate the effects). plies, rules, and processes of work is a means to reduce errors
and potential failures.
102
Chapter 6: Redesigning the Process
Clinical practice guidelines standardize the care and treatment Simplifying Processes
of individuals with a particular indication or diagnosis. They Simplification reduces process complexity, which is often at
can improve care and reduce costs and the probability of the root of process failure. It involves reducing the number of
process failure. For example, protocols for use of hazardous or steps and handoffs in work processes as well as standardizing
high-alert drugs can reduce the likelihood of failures at numer- language and tasks.3 Simplification often involves centralizing
ous steps and linkages of steps in the medication use process. activities that are similar but carried out in a variety of loca-
Protocols for identifying individuals at risk for falls or suicide tions and settingsfor example, implementing a pharmacy-
can reduce the likelihood of failures of steps and links in the based IV admixture program.4 Simplification should not be
assessment process. confused with taking shortcuts, however. Shortcuts eliminate
essential process steps or links. Taking shortcuts, including
One standardization activity that organizations should consid- breaking safety rules such as failing to wash ones hands
er is standardizing communication between caregiversin between contact or guessing at the meaning of an illegible
other words, determining a common language that a health medication order, is often without immediate consequences,
care team can use to communicate about care. For example, in and it relieves the perpetrator of the burden imposed by the
the area of electronic fetal monitoring, there has been a call to rules, thus reinforcing the behavior.5
standardize language for fetal heart rate interpretation in order
to decrease the risk of adverse outcomes. Providing definitions Optimizing Redundancy
of standardized nomenclature for use in the documentation of Optimizing redundancy means developing backups and back-
electronic fetal heart rate tracing and in interdisciplinary com- ups to backups to reduce the probability of failure. Building
munication regarding such tracings can help everyone be on redundancy into system redesign can increase system reliabili-
the same page and prevent errors from occurring because of ty by creating a system that accomplishes what the primary sys-
missed cues.2 tem does should the primary system fail.5 The cost of such
redesigns may be an issue in many instances in the health care
One type of activity that can be used to standardize a process environment. However, simple redesign strategies, such as hav-
is the development of a critical pathway (also referred to as ing a second individual check the work of another, are com-
critical path or clinical pathway). The primary objective of a mon in health care and can decrease the chance that a failure
critical pathway is to reduce common-cause variation, thereby may reach the individual. For example, two staff members ver-
reducing the risk of special-cause variation in dependent ifying the name on the armband against the name on the label
processes. Critical pathways offer a systematic, flexible guide on the blood bag at the bedside before a blood transfusion
for standardization of care that can start, for example, before begins is a built-in redundancy that reduces the likelihood of
admission and follow the care recipient across all care settings. transfusion errors. Having nursing or pharmacy personnel do
They are designed by those involved in the processclients, a verbal read-back on verbal medication orders requires some
clinicians, pharmacists, and otherswho come together to additional investment of time but has been shown to reduce
offer their unique perspectives and expertise. interpretation errors.
Using a clinical pathway is an excellent way to redesign an Backups are maximally effective when they are independent of
existing clinical process that needs change. One advantage of the primary system and not subject to the same external influ-
using a critical path is the opportunity to start fresh, cast aside ences.1 For example, having two nurses check the same docu-
traditional but not particularly effective procedures, and ment to verify the care recipients identity may not be as effec-
research and implement the best practices. Many critical path- tive as having them each verify identity by using a different pri-
ways have been developed to date by numerous organizations, mary source. Backup emergency electrical power supply
including professional societies, health care organizations, and involving an emergency generator that kicks in whenever the
governmentuse of predetermined pathways to redesign or to community-supplied power drops below a critical voltage level
enhance existing clinical processes can also be helpful in stan- provides an example of true redundancy. The secondary back-
dardization. up system is independent of the primary and is automatically
activated in response to the detection of a primary system fail-
A summary of the steps involved in critical pathways develop- ure. Both are independent of human intervention.
ment and implementation appears as Sidebar 6-1, page 104.
103
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 Team members must reach consensus on the key activi-
process to standardize. Consider selecting a process that: ties involved in each stage of the care process. Members
Affects a high number of the care population can draw on personal experience and knowledge, exist-
Has a high level of variability in treatment and out- ing clinical literature and practice guidelines, and the
comes care recipients perspective. When varying styles or
Has clear start and end points methods of care ariseand they inevitably willthe
Staff expresses a desire to develop 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 sim- Subsequent outcome measurement may demonstrate an
plify critical pathway development. A process that is advantage of one path over the other. The path need not
too broadly defined will result in a path that is either be limited to clinical activities; it can also include activ-
too complex or too vague; conversely, a process that is ities that surround the clinical process, such as trans-
too narrowly defined can result in a path that applies in portation to the radiology department. Critical path-
only a limited number of cases. ways should also include descriptions of expected out-
comes. Despite the complexity of the processes
Forming a Team involved, teams should attempt to make their paths as
The group that creates the critical pathway must repre- concise as possibleone page is idealso they can be
sent all disciplines involved in the process, with a focus used as practical tools in daily practice. At all stages of
on those who perform the hands-on tasks of the the care process, staff can refer to critical pathways. The
process. The scope of the process will help determine paths should be available to all involved personnel in all
team members. Another valuable perspective can come the relevant work areas and office locations. Critical
from the care recipient and their families or caregivers, pathways are also valuable for the individual receiving
customers, and others, such as representatives from care, treatment, or services; they can increase knowledge
social services agencies. The team should elicit informa- and sense of partnership with providers.
tion from the people the process is designed to benefit.
Sources: Panella M., Marchisio S., Di Stanislao F.: Reducing
Similarly, if other parties are involved but are not team Clinical Variations with Clinical Pathways: Do pathways work? Int J
members, their input must also be elicited. Qual Health Care 15:509521, 2003; Holloway N. M.: Medical-
Surgical Care Planning, 4th Edition. Philadelphia: Lippincott
Williams & Wilkins, 2003, pgs. 1921.
Teams should consider that designing in redundancy almost ent on human intervention. For example, computerized order
always increases the complexity of processes. With increased entry systems can reduce medication prescription failures that
complexity comes an increased risk for failure. The failure of a result from bad handwriting, and they can check the consisten-
redundant system may not be evident until the backup system cy of drug and dosage. Computerized medication order entry
is needed.5 Increased complexity and new potential failures systems can increase the likelihood of intercepting failures,
should be weighed against possible benefits in each case of including drugdrug interactions, allergies, out-of-range
process redesign. Backup processes require regular testing to doses, and contraindications. Electronic medical records can
ensure their continued effectiveness. help reduce the amount of paperwork required by medical
professionals and free up time for care processes. They can also
Using Technology help enhance error prevention by reducing the reliability on
Automation or technology can reduce the likelihood of failures human memory. Checklists and screens for risk assessment,
associated with inconsistent or variable input or failures asso- pop-up menus for physical assessment, and programmed ques-
ciated with processes or process steps that are heavily depend- tions for histories or data collection are just a few of the ways
104
Case Study
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 hospitals 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 an automated order entry system who dislike dealing with mul-
medical professionals ability to remember every step of a tiple error messages may be able to disable the messaging system
process.2 effectively. This can actually increase the risk of harm.
Technology and human intervention should be considered com- Automated dispensing machines can be misused as well as prop-
plementary rather then competitive.1 Good performance erly used. For example, routine overrides, available on some
requires judgment, creativity, the ability to recover from failure, automated dispensing units, allow nurses to retrieve medications
good memory, vigilance, endurance, attentiveness (focus), and without a review of the order by the pharmacist. This represents
patience. Human performance exceeds that of technology in the a significant risk point.
first three of these activities; technology is better at the rest.
Computers and other technologies lack the ability to make Creating Fail-Safe Designs
allowances for incomplete or incorrect information and can A fail-safe design is a design that will tend to revert to a predeter-
therefore avoid possibly problematic situations. Technology is mined safe state with respect to if a failure occurs. It is usually
more consistent and is better at receiving, storing, and analyzing safer to refrain from actingat least for a little whilethan to
information. Technology does not take shortcuts. It is not influ- proceed and act incorrectly. Consequently, a process that detects
enced by emotion.5 However, human judgment is still superior failure and interrupts action is preferable to a process that pro-
to a machine when dealing with an unanticipated contingency ceeds in spite of the failure. This often means pausing the
and adjusting the process to avoid harm.5 process to allow for human intervention to assess and deal with
the contingency that has caused the interruption.5 Built-in free-
The benefits of introducing technological or automated ele- flow protection on an IV infusion pump is an example of fail-
ments in process redesign should be carefully weighed against safe design. One failure mode for older-model infusion pumps
the risk of removing humans from the picture. For example, bar occurs when the cassette dislodges from the pump mechanism.
coding, prescriber order entry systems, and automated dispens- When this happens, the entire contents of the IV solution rap-
ing machines can be used to reduce the likelihood of harm to idly flow into the individual (for example, 3 liters in 10 min-
individuals that results from failures in the medication use utes). Death due to the inadvertent rapid infusion of toxic
process. However, integrating new technologies into existing drugs can occur.
processes requires an understanding of the goals of change. Not To address this failure mode, pump manufacturers have modi-
all change results in the desired improvement. Physicians using fied the design to clamp down, or shut off the flow of medica-
105
Case Study
Conducting FMEA to Prevent Pressure Ulcers
at Gaylord Hospital
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 clin-
ical 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 Documentation
have designed the normal position for the line clamp to be High-quality documentation can reduce the likelihood of fail-
closed. When the cassette is inserted into the pump, the clamp ure at various steps or links between steps in a health care
opens. In this case, designers have determined that no flow is process. The objective of any document, like that of any con-
safer than too much flow, so they have selected no flow as the versation, is communication; the sender and receiver of the
fail-safe mode designed into the system. information must share an understanding of what is being
reported. If time constraints are too tight (or loose), or if steps
The design of anesthesia equipment also provides a fail-safe are tightly coupled, complex, or nonstandardized, documenta-
mechanism. Connectors of cylinders for nitrous oxide and oxy- tion can provide the opportunity for caregivers to check the
gen are now different sizes so that they cannot be mistakenly correctness of the care recipients treatment at a critical point.
connected. Similarly, oral medications can be placed in syringes Sophisticated management information systems and computer-
or other containers that cannot be connected to needles or IV ized clinical records are increasingly used in various health care
tubing. organizations. They are helpful tools but are only as reliable as
the information on which they are based.
Constraints, or forcing functions, are aspects of a design that
prevents a target action from being performed or allows its per- FMEA teams should be aware that multiple entries or duplica-
formance only if another specific action is performed first.6 For tion of documentation increases the failure risk of a process step
example, one of the first forcing functions identified in health or link between steps. Certain technology systems may be able
care was the removal of concentrated potassium from general to overcome this risk. Computerized prescriber order entry, for
hospital wards. This action is intended to prevent the inadver- example, can eliminate many of the problems associated in the
tent preparation of intravenous solutions with concentrated medication use process with multiple entry and duplication of
potassium, an error that has produced small but consistent num- data. Computerized prescriber order entry creates a single
bers of deaths for many years.6 This reduces reliance on human source of information about the prescribed medication so that
memory or attentiveness, which can fail if time constraints are the data need not be reentered numerous times but can be
too loose or too tight or if vigilance is required for a prolonged accessed and formatted by different professionals at different
period of time. locations. For example, the pharmacy staff can use the data for
106
Case Study

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 inter-
preted differently by physicians, nurses, and pharmacists. The order sets needed to be redesigned to make it eas-
ier 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 auto-

Change 7-day ASO to 30-day ASO Short term
matic stop order (ASO)
Suboptimal patient involvement in Promote use of comprehensive

Short term
medication histories Patient Home Medication List
Develop electronic prompt to

Suboptimal medication reconciliation
enhance accuracy of medication Short term
by clinicians
reconciliation
Confusing epidural and patient-

controlled analgesia (PCA) order Revise order sets Short term
sets
Orient current staff to real-time

Lack of electronic medication admin-
Pharmacy folder in electronic Short term and long term
istration record (eMar)
record
Lack of computerized order entry

Implement CPOE Long term
(CPOE)
the pharmacy medication record; the nursing staff can use the and the number of handoffs can be reduced to decrease the risk
data for the medication administration record. With a single of failure; perhaps time constraints can be loosened or an
source for the data, the risk of transcription errors is reduced. alarm system can be introduced to increase detectability of fail-
ure when it does occur. Sending e-mail and mailing letters in a
Reducing Coupling postal box are tightly coupled processes. Once the sender has
Another redesign strategy that deserves consideration is reduc- clicked on the send button or dropped the letter in the mail-
ing the force with which the process steps are coupled, or less box, there is no way to undo the command or reclaim the let-
tightly coupling the process steps. One goal is to reduce the ter. Perhaps an additional step could be added to each process.
speed of step sequencing so that when a variation occurs in one Another redesign strategy involves tightening time constraints to
step or link, it can be responded to before the next step or link help decrease failures that result from boredom, inattentiveness,
occurs. Perhaps the number of steps can be reduced and the or fatigue. Perhaps the basic design of the process steps needs to
process simplified; perhaps the number of persons involved be examined and additional steps considered.
107
Providing Comprehensive Education financial support. If staff members are expected to volunteer
Inadequate processes for orientation and training are the second unpaid time to attend courses, there is likely to be resistance and
most frequently cited root cause for all types of sentinel events. resentment; health care organizations should consider providing
Education and training provide the foundation of professional incentives or paying staff for this training time.
competence. Health care professionals are trained extensively
prior to assuming care functions. Unfortunately, in our society, Establishing a Culture of Teamwork
after initial training, their performance is expected to be flawless. While health care organizations are increasingly focusing on
Training is time limited in its effectiveness and therefore requires teamwork in the care environment, communication problems
ongoing reinforcement, reassessments, and revision to keep pace are still one of the most frequently cited root causes for all types
with evolving health care knowledge. of sentinel events.
Education and training constitute traditional proactive and reac- Teams can be used effectively in improving organization per-
tive initiatives to reduce and prevent errors. Unfortunately, they formance and in delivering safe care. Health care organizations
feed into the notion of perfect performance and the belief that must recognize the importance of groups functioning as teams
flawed human performance is the root cause of failures. Often, and create interdisciplinary teams or task forces charged with
efforts to retrain personnel following the occurrence of errors or improving organization performance. Studies have found that
sentinel events focus on eliminating human error. Such efforts health care organizations with a teamwork orientation tend to
also are often substitutes for a substantive effort to identify, have greater success in their quality improvement efforts.8,9
study, and eradicate systems problems.
Other studies have linked team performance to positive out-
There are effective educational and training approaches that comes.10 Teamwork is important not only in complex and
emphasize systems rather than humans as causative factors for dynamic environments such as operating and emergency
potential or actual failures and the critical preventive role per- rooms but throughout care functions and processes. For exam-
formed by humans. Yet even these approaches are not bullet- ple, rounding teams, including representatives from all disci-
proof. How can one simulate events that have not yet happened, plines, can direct care at the bedside. One way to test an orga-
but could? Or how can one simulate events that have not been nizations teamwork interactions is to conduct a survey among
foreseen?7 staff. Questions for this survey may include the following2:
Are you comfortable discussing issues with the team?
James Reason developed four error management principles that Do you feel you can freely discuss other team members
can be applied to training7: deficiencies and unproductive behaviors?
Training should teach and support an active exploratory Do team members apologize to one another when they
approach. Trainees should be encouraged to develop their say or do inappropriate things?
own mental models of the system. Do team members openly admit mistakes or weaknesses?
Error training should form an integral part of the overall Do team members take a genuine personal interest in each
training process. Trainees should have the opportunity to other?
both make errors and recover from them. Do team discussions end with clear and specific plans?
The heuristics of errors should be changed from mistakes Do team members understand their responsibilities?
are undesirable to it is good to make mistakes; they help Do team members recognize each others contributions
learning. and thank each other for their input?
Error training should be introduced at the appropriate
point; midway through a training program. Early in the Organized teamwork can and should provide the impetus for
learning process, trainees are struggling with every step and the bulk of organizational performance improvement initia-
are unlikely to benefit from error feedback. Later, they are tives. All FMEA teams should consider redesigning problem-
better equipped to learn from such feedback. atic processes to encourage a team focus.
Many organizations face challenges when trying to introduce Taking a Methodical Approach
new kinds of training programs, such as those centered on team When designing strategies it is helpful to take a methodical
coordination or improving communication. The challenges approach. It is also important to remember that existing
derive from the fact that training programs require time and processes likely have many good features. It should be clearly
108
Case Study

Completion Process at Health Care for the Homeless (HCH)
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 doesnt 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 Workability. How doable is the redesign element? Does
problem may be in the implementation phase of the process, the organization have the resources to make the improve-
not in its actual design. Shortcuts may be taken that have the ment happen?
effect of bypassing important redundancies. In these cases, Barriers to implementation. What are the barriers that this
teams should examine why shortcuts are taken and address redesign element will likely face during implementation?
those underlying causes. How receptive will management, staff, physicians, and
others be to the redesign element? What will be involved
Sidebars 6-2 and 6-3, pages 112 and 113, respectively, provide in eliminating barriers to implementation?
some suggestions on how to reduce risks in several high-risk Compatibility. Is the redesign element compatible with
areas. the organizations objectives and mission?
Availability of resources. What will implementation of the
Considering the Impact of Redesign redesign element cost? How much staff time will be
Elements involved? Is the organization prepared to dedicate all the
Once the FMEA team has identified various approaches to resources necessary to implement the project? What type
improving problematic process steps or links, the team is ready of training is involved to bring staff up to speed? Is the
to evaluate the alternatives and select those that are most like- organization willing to invest in staff education?
ly to be successful in preventing failures. The process of evalu- Implementation time frame. How long will the redesign
ating redesign elements begins with the teams consideration of and testing take?
evaluation criteria, including the following: Measurability and objectivity. How objective is the
Chance for success. How likely is the redesign element to redesign element? How will improvement be measured?
succeed in preventing the failure?
Staying power. How likely is the redesign element to effect Asking and answering these key questions and those outlined
a long-term versus a short-term solution? in Sidebar 6-4, page 114, will help the team identify potential
Reliability. How reliable is the redesign element? Will it barriers to implementation with each redesign element.
work all the time? Part of the time? Teams can rank the redesign elements according to all or
Risk. How likely is the redesign element to engender other selected criteria. Having team members perform their own
adverse effects within the process or in another health care ranking and then consolidating the ranking into an overall
process? What would happen if this redesign element were group ranking helps to prevent group think. To summarize
not implemented? the potential of each redesign element, the team can ask,
109
Case Study
Conducting FMEA on Medication Requests at
Amerikan Hastanesi

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 Prioritized Failure

Process Step Main Causes What Can Be Improved?
Rank Modes
1. Clarification of emergency-urgent
Mix-up of concepts of
Porter leaves An emergency concepts
Emergency and Urgent.
4 order at the order is left for 2. Informing
Non-detection of state of
Pharmacy. later. employees
emergency.
3. Transition to pneumatic system
1. Setting up a division of labor bulletin

board
Confusion in division of 2. Separating work spaces at the
labor Pharmacy
Heavy telephone traffic 3. The Pharmacys contacting the
Divisions stemming from floors first
technicians training 4. Sending out reminders or e-mail for
Carrying out all proce- timely requests of narcotics
Orders are con- Wrong medication dures at the same desk 5. Encouraging the accompanying of
trolled and pre- is given (dosage, Narcotics not being physicians on patient visits; adding
5
pared by mode, name, for- requested promptly this to the employees performance
Pharmacy staff mula) Magistral medications not evaluation system
being requested promptly 6. Pharmacy orientation program
Illegible order 7. Contacting the physician in the
Placing returned medica- event of an incomplete order
tion on wrong shelf 8. Checking and arranging shelves
Incomplete writing out of where medication is stored at the
order pharmacy to improve visual display
and make high-risk medications
stand out
1. Review of control system

2. Defining major drug-drug interac-
tions, adding information about
Orders are con-
Drug-drug interac- Leaving implementation interaction on the physician's order,
trolled and pre-
5 tion check is not for later System is not writing of a pharmacist's note
pared by phar-
made clearly known 3. Writing of the pharmacists note in
macy staff
red so that it is better seen
4. Sharing of the interaction table over
Ahnet.
110
Case Study
Amerikan Hastanesi, continued
Prioritized Failure
Order Rank Process Step Main Causes What Can Be Improved?
Modes
1. Pharmacists checking
medications coming from
home in the
Chemotherapy Unit
Writing of orders with- 2. Pharmacists checking
out calculating medications brought in
Physicians using from home by patients on
Order is sent to
Mistake in the repeat their own prescrip- inpatient floors, in accor-
1 chemotherapy
order tions dance with the admissions
nurse
Not checking medica- list sent in daily by Patient
tions coming from Admissions, and writing
home Has been controlled on
and signing the Discharge
Plan form
3. Adding an oncologist to
the team
Order is sent to
Mistake in the repeat
1 chemotherapy
order
nurse
1. Setting up an urgent draw-

Nurse pulls out the
er in every department
original and first
The failure of employ- 2. To set up urgent lists by
copy of the order Mistake in an Urgent-
2 ees to understand the floors
from the file and the Emergency Request
concept 3. Informing employees
medication is put
4. Putting Dext.10% in
into the request bag
Urgent Drawer (5A-5B)
Drug-food interaction
Orders are con-
controls are not followed Not knowing the sys- Informing Pharmacy
5 trolled and prepared
and orange warning tem employees
by pharmacy staff
label is not attached
Interruption in med-
Orders are con- ication information Preparing labels containing
Failure to label medica-
5 trolled and prepared due to termination of the name of the medication
tions (Expiry date, name)
by Pharmacy staff medication adminis- and Expiry Date information
tered in a single dose
Orders are con- Medication label is not

Heavy workload, Medication labeling risks are
5 trolled and prepared attached to medication
writing by hand eliminated
by Pharmacy staff bag
111
Sidebar 6-2. Reducing Medication Errors: Risk-Reduction Suggestions
To reduce the likelihood of failures associated with pre- Establish and implement policies and procedures for
scribing errors: use of an off-hours pharmacy.
Implement a system of computerized order entry by
physicians (to decrease the likelihood of dosage errors, To reduce the likelihood of failures associated with med-
prompt for allergies, and provide information on ication delivery:
drugdrug and drugfood interactions). Be sure that equipment defaults to the least harmful
Redefine the role of pharmacists to enable them to mode.
perform daily rounds with physicians, work with regis- Use automated pharmacy units as a tool for improving
tered nurses, and serve as on-site resources. the process, not as an inherent solution.
Recognize that polypharmacy equals higher risk.
To reduce the likelihood of failures associated with dis-
pensing:
To reduce the likelihood of failures associated with
Do not rely on color-coding. human resources and competence factors:
Remove look-alikes. Address education and training issues (orientation,
Bar code, if possible. competence assessment, and training with new med-
Avoid lethal medications in bolus form. ications and devices).
Use premixed solutions, when possible. Support professional ethics and judgment.
Minimize supplier/product changes. Implement systems that involve double checks.
Use auxiliary labels (such as, for IM [intramuscular] Make safe staffing choices.
only). Tackle illegible handwriting.
Support questioning of unclear orders. Discourage the use of acronyms and abbreviations.
Eliminate guessing. Control the availability of high-risk drugs.
Address environmental issues (for example, tackle dis-
To reduce the likelihood of failures associated with access traction and its impact).
to medications: Standardize medication times.
Remove high-risk medications from care units. Use the care recipient as a safety partner.
Label high-risk medications as such.
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 sus what are going to have to be accomplished in stages or be
What would result from not implementing this action? delayed until resources are available. For example, posting
more signage warning of the dangers of smoking around can-
New Processes Present New Problems ister gas is a solution that can be implemented right away.
FMEA teams must be aware that any process redesign changes Building a new building to house the canister gas is a long-
the inherent risk points. This means that in the new term project that requires board approval, capital outlay, and
several steps in order to be accomplished. Not all problems can
Long-Term Versus Short-Term Plans be solved immediately; leadership should give input on which
Depending on the number and scope of actions the team projects can be tackled now versus which ones should be
develops, it may be necessary to develop long-term and short- delayed. A written long-term plan may be helpful so that team
term plans of implementation. In other words, the team may members see that management is not ignoring problems, just
need to determine what actions can be implemented now ver- prioritizing how the problems get fixed.11
112
Sidebar 6-3. Risk-Reduction Suggestions for Common Risks
Risk-Reduction Strategies for Restraint Use Be cautious at times of change (admission,

Do not restrain the individual in the bed with unpro- discharge, passes).
tected, split side rails. Be suspicious if symptoms lighten suddenly.
Use the appropriate restraint for person, age, and goal. Involve all staff in the solutions.
Never use a towel, bag, or cover over an individuals
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 identifica-
tive 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 signif-
a 24-Hour Care Setting icant other immediately after birth.
Revise assessment/reassessment procedures and assure Footprint the baby, take a color photograph of the
adherence. baby, and record the babys physical examination
Update the staffing model. within two hours of birth.
Educate staff on suicide risk factors. Require staff to wear up-to-date, conspicuous, color
Update policies on observation. photograph identification badges.
Monitor consistency of implementation. Discontinue publication of birth notices in local
Revise information transfer procedures. newspapers.
Revisit contraband policies. Consider options for controlling access to
Identify and remove nonbreakaway hardware. nursery/postpartum unit such as swipe-card locks,
Weight-test all breakaway hardware. keypad locks, entry point alarms, or video surveillance
Redesign or retrofit security measures. (any locking systems must comply with fire codes).
Educate family and friends on suicide risk factors. Consider implementing an infant security tag or
Consider the care recipient in all areas. abduction alarm system.
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).
113
Using Redesign Evaluation and

Redesign Tools Sidebar 6-4. The Impact of Suggested
A number of tools or techniques can be quite helpful to teams Redesign Elements
in identifying possible redesign approaches or strategies and
evaluating and prioritizing these (Chapter 5 gave more details Organization Processes
on these tools). Brainstorming can help a team identify ways How does the proposed redesign element relate to
to redesign a process. Multivoting and selection grids can help other projects currently under way in the organiza-
a team prioritize possible redesign actions. Cause-and-effect tion? Are there redundancies?
diagrams can help indicate which redesign changes might How does the redesign element affect other areas
cause the desired result or goal. Pareto charts can be used to and health care processes?
help determine which redesign elements are likely to have the What process-related changes might be required?
greatest effect in reaching the goal of reducing harm to the Can affected areas absorb the changes/additional
individual. Gantt charts and action plan matrixes can help responsibilities?
teams track the major improvement actions, milestones, and
progress toward meeting the completion time frames. Resources
What financial resources will be required to imple-
In Chapter 7, you will learn how to analyze and test your ment the redesign element? (Include both direct
redesigned processes to find out whether they will bring about and indirect coststhat is, costs associated with
the improvements you want. 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?
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?
114
References
2. Miller L.: Safety promotion and error reduction in perinatal care:
Lessons from industry. J Perinat and Neonatal Nurs 17:128138,
Apr.Jun. 2003.
3. Raouf E.N.: Error reduction in surgical pathology. Arch Pathol Lab
Med 130:630632, 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.
2527, 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:i85i90, 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 18:2126, 2001.
10. Temkin-Greener H., Kunitz S.: Measuring interdisciplinary team
performance in a long-term care setting. Med Care 42:472480.
May 2004.
11. Spath P.: Get more out of your FMEAs. Hosp Peer Rev 29:1316,
Jan. 2004.
115
116
Chapter 7
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
Step 1
effect of an error that does reach someone. The team has evaluated and assemble a team.
prioritized redesign elements. At this point, the team is ready to con-
sider how to put the process redesign in place.
Step 2
Organizing for Implementation Diagram the process.
The FMEA team is ready to start planning for the implementation of spe-
cific 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? Step 3
Brainstorm potential failure modes
How? and determine their effects.
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 Step 4
expectations, the organization will not be able to determine the degree Prioritize failure modes.
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 Step 5
and resources will be required to meet these expectations? How and
what will the team measure to determine whether the process is actu-
modes.
ally performing at the expected level?
The FMEA team needs outcome measuresspecific measures of the

performance of the redesigned or improved processin order to deter- Step 6
mine whether expectations are met. These measures can be taken direct- Redesign the process.
ly 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
Step 7
doses is cited as a corrective solution for one failure mode, the measure Analyze and test the new process.
should evaluate competence before and after each training or education-
al session. The measure might state that all staff should achieve at least a
certain postimprovement test score, for example. Step 8
At times, it might be difficult to establish quantitative measures; the redesigned process.
redesign may simply seem to lend itself more to qualitative measures.
117
Case Study
at Miami Valley Hospital
Step 7: Analyze and test the process.

After identifying the process changes, the FMEA team recalculated the risk priority numbers based on the predict-
ed 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 discrep-
ancies 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 Furthermore, their authority to make changes should be com-
solutions can be measured only in terms of risk-reduction mensurate with their responsibility for process improvements.
potential, it is important to try to quantify such potential as While regular feedback and contact with management are
much as possible through concrete measures. important, rigid control can stifle creativity. Once each step
has a designated responsible party, it is important to emphasize
When? the necessity of completing the assigned actions. If people are
Next, the FMEA team defines when the organization must not aware of the importance of their roles, actions could get
meet its redesign goals. What time frame will be established for delayed, forgotten, or just not done. Responsible parties
implementing the redesign elements? What time line will be should be given the expectation of what needs to be accom-
established for each activity in the steps along the way? What plished and by when, with regular opportunities to report the
are the major milestones and their respective completion dates? status of the activity.
Who? Where?
Who is closest to this process and therefore should own the Where will the redesign element be implemented on a pilot
redesign element? Who should be accountable at various test basis? Will its pilot testing be in a selected location with a
stages? The success of an improvement effort hinges on involv- selected care recipient population or selected staff members?
ing the right people from all disciplines, services, and offices Where will it be implemented organizationwide following
involved in the redesign element being addressed. The group pilot testing success? Is the location, target population, or tar-
that redesigns a process step or link should include the people get staff of the redesign element likely to expand with success?
responsible for the process step or link, the people who will
carry out the step or link, and the people affected by the step, How to Communicate Change
link, and overall process. Hands-on participation in the Throughout the FMEA, the team communicates its conclu-
redesign by end users is critical both to consideration of all rel- sions and recommendations as outlined early in the process
evant end-user issues and facilitation of ultimate end-user buy- when the team determines its scope and boundaries. Thorough
in. Leaders must ensure that the people involved have the nec- communication is critical to success. After the team identifies
essary resources and expertise. the redesign strategies it wishes to pursue, the team should
provide leadership with its redesign recommendations.
118
Chapter 7: Analyzing and Testing the Process
Case Study
Conducting FMEAon the Opioid Prescribing
The processes were rolled out in stages, for two reasons. First, the team wanted to observe the changes in prac-
tice 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) resulting in 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 such as variable input, lack of standardization, hierarchical
information they need. The FMEA team should consider care- interaction, and so on, but in the process it may introduce
fully how and to whom the report is to be presented. It should other risk factors, including the following:
consider the following when communicating about process Input/output mismatch. Each step in a process requires an
redesign: input and yields an output that is often the input for
How will implementation of the redesign be communicat- another step.4 Redesigning a subprocess without paying
ed throughout the organization? Who needs to know? attention to its interrelationships can result in a mis-
What communication vehicles will the team use for vari- matched input from the upstream process or a faulty input
ous audiences (individuals both directly and indirectly to the remaining downstream process.
affected by the redesign)? Oversimplification. An organization may eliminate neces-
Participants during a formal oral presentation should sary safeguards, such as protective redundancies, in trying
include those whose approval and help is needed and to reduce steps.
those who could gain from the teams recommendations. Added complexity. This is the opposite of oversimplifica-
tion. Complex processes are more prone to failure than
Testing the New Process simple ones; additional steps may come with attendant
Once the redesigned process has been planned for, it is impor- failure modes.
tant for the team to test it before full-scale implementation Reliance on unreliable systems. A form of excessive com-
begins. Not only should a team test any new processes that are plexity, this is seen in many technical solutions (for exam-
created, but it should also evaluate the effect of new sub- ple, implementing computerized provider order entry with-
processes on the larger process before implementing changes.1 out adequate decision support software) or in checks that
This can be an instructive process and less expensive than a are not independent and therefore not truly redundant.
premature adoption of a well-intended but faulty design.2 Tight coupling. Failure often occurs at the point of con-
nection (coupling) in a series of actions. If the steps in the
With any significant redesign, unexpected and unintended process follow so tightly that variation cannot be recog-
consequences can occur. In some cases, the new risk may be nized and responded to before the next step begins, the
more serious than the potential risk the process is intended to process eliminates opportunities to identify failures and to
prevent.3 When redesigning a process, the new redesign may intervene to protect.
address one of the several risk factors involved in the process, Variation from usual or intuitive behavior. Changing a
119
Case Study
Gaylord Hospital

During the testing process, the team checked each patient weekly to track the effectiveness of the new proce-
dures 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 intro- Then, to determine whether the proposed redesign will pre-
duce human error. This is particularly dangerous when vent the failure entirely (decrease likelihood of occurrence),
the individuals involved (such as medical staff ) function prevent the failure from reaching the individual (increase the
in different settings that have contrasting policies. For probability of detection), or protect the individual if the fail-
example, a policy of marking the opposite side from an ure occurs (decrease the severity of the effects), the team
intended surgery rather than marking the intended site should calculate a new criticality index or risk priority number
introduces a risk for error. (RPN) for the failure mode. Design improvements should
bring a significant reduction in the criticality index or RPN.
When testing a new process or subprocess, several strategies What is significant? Is a 50% reduction the goal? Or would the
can ensure the highest likelihood of success: conducting a team be willing to implement a redesign with the goal of
paper test FMEA, simulation, and pilot testing. Each of these achieving a 30% lower RPN, for example? Each team defines
strategies must involve input from a multidisciplinary team this for a particular process. Not every process will have the
that has a clear understanding of the problematic process and same goal. Factors such as severity, occurrence, detection, and
the proposed redesigned one. so on affect the risk-reduction goal for the process.
Paper Testing Simulation

The first strategy the team might use may be to analyze the A team may be able to use simulation to test a new design
redesigned process on paper. FMEA again provides an within a risk-free environment. Simulation allows the organi-
approach for doing this. Fault-tree analysis and other analyti- zation to experience the implications of a redesign without risk
cal techniques can also be used to test the redesigned process to the individual receiving care.2 A paper stress test or comput-
on paper. er-based simulation exercise can help a team anticipate the full
range of decision-making and performance issues that might
In applying FMEA to the redesigned process, the team again arise with a new process design. Such a test involves playing
completes steps 3 (diagram the process, brainstorm potential out how the new process will function when several worst-case
failure modes, and determine their effects) and 4 (prioritize conditions or variables converge at the same time. For exam-
failure modes) of the FMEA process. A new flowchart of the ple, a computer-based test on patient-controlled analgesia
redesigned process is appropriate at this point. It should indi- could examine the individual and collective effects when sev-
cate the new steps and links between steps proposed by eral failure modes occur in one patient case, such as a wrong
redesign improvements. Teams can brainstorm about new fail- analgesic or dose selection, errors entering the pharmacy com-
ure modes and effects that might be introduced by the new puter from an illegible order, and an inadequate check of the
design elements. It can consider possible new failure modes in patient-controlled analgesia pump, resulting in the wrong flow
subprocesses and related processes. rate.5 A simulation can reveal potential unanticipated side
120
Case Study
After implementing the process changes, Amerikan Hastanesis 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 severi-
ty 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 col-
umn serves as a reminder of the order of the steps in the overall process.
Prioritized
Order Process
Failure Main Causes What Can Be Improved? Sev. Occ. RPS
Rank Step
Modes
Mix-up of concepts 1. Clarification of emer-

An emer-
Porter leaves of Emergency and gency-urgent concepts
gency
4 order at the Urgent 2. Informing employees 5 2 10
order is left
Pharmacy Non-detection of 3. Transition to pneumatic
for later
state of emergency system
1. Setting up a division of
labor bulletin board
2. Separating work
spaces at the
Confusion in division
Pharmacy
of labor
3. The Pharmacys con-
Heavy telephone
tacting the floors first
traffic
4. Sending out reminders
Divisions stemming
or e-mail for timely
from technicians
requests of narcotics
training
5. Encouraging the
Wrong Carrying out all pro-
accompanying of
Orders are medication cedures at the same
Physicians on patient
controlled is given desk
visits;adding this to the
5 and prepared (dosage, Narcotics not being 9 5 45
employees perform-
by Pharmacy mode, requested promptly
ance evaluation system
staff name, for- Magistral medica-
6. Pharmacy orientation
mula) tions not being
program
requested promptly
7. Contacting the
Illegible order
Physician in the event
Placing returned
of an incomplete order.
medication on wrong
8. Checking and arrang-
shelf
ing shelves where
Incomplete writing
medication is stored at
out of order
the Pharmacy to
improve visual display
and make high-risk
medications stand out
(continued)
121
Case Study
Order Prioritized
Process Step Main Causes What Can Be Improved? Sev. Occ. RPS
Rank Failure Modes
1. Review of control sys-

tem
2. Defining major
drugdrug interactions,
adding information
Orders are Leaving implemen- about interaction on the
Drug-drug inter-
controlled and tation for later Physician's order, writ-
5 action check is 5 3 15
prepared by system is not ing of a Pharmacist's
not made
Pharmacy staff clearly known note
3. Writing of the
Pharmacists note in red
so that it is better seen
4. Sharing of the interac-
tion table over Ahnet
medications coming
from home in the
Chemotherapy Unit
Writing of orders
medications brought in
without calculating
from home by patients
Order is sent Physicians using
on inpatient floors, in
to Mistake in the their own prescrip-
1 accordance with the 9 3 27
Chemotherapy repeat order tions
admissions list sent in
Nurse Not checking med-
daily by Patient
ications coming
Admissions, and writing
from home
Has been controlled
on and signing the
Discharge Plan form
3. Adding an Oncologist to
the team
effects of variations in the process and, in the case of comput- ensure that the redesign is successful before committing signif-
er simulation, has the further advantage of allowing things to icant resources to the redesigned process. This is a good time
play out in compressed time to reveal long-term effects, note to examine any human factors issues present in the new
Croteau and Schyve.4 process. For example, the organization might look at how the
new process intersects with the behaviors, limitations, and skill
Pilot Testing sets of the people who are involved with the process. This is
If the paper-tested or simulated process redesign looks promis- also a good time to gather feedback from staff involved in the
ing, conduct a pilot test to determine the real-world effective- process. Because they are the ones who will be carrying out the
ness of the new process. Through pilot tests, a team imple- process, it is important to get their feedback. Pilot testing also
ments the redesign on a small scale, monitors its results, and aids in building support for the new design, thereby facilitat-
refines the redesign as necessary, without taking the risks asso- ing buy-in by opinion leaders.
ciated with full-scale implementation. This enables the team to
122
Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction Chapter 7: Analyzing and Testing the Process
Case Study

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, Data Collection Strategies
organizations might want to consider a pre-and postsurvey of There are a variety of ways an organization can collect data,
staff involved in the pilot test. This can provide information including the following:
about how the group feels about the process before and after Record review
the revisions. It can help gauge staff approval and buy-in and Pre-and post-survey
identify any potential barriers to implementation. Reporting system
Observation
Measurement is an important aspect of any pilot test. Focus group
Outcome measurement is used to learn about the results of a Attendance at education programs
process, whereas process measurement provides information Competency assessment
about what causes those results. When testing a redesigned
process, a team can use both outcome measures and process It is helpful to coordinate any ongoing measurement with data
measures. However, use of process measures ensures a focus on collection already taking place as part of the organizations
more than just subsequent failures. Measuring factors such as everyday activities.
consistency, completeness, accuracy, and timeliness provides
greater assurance about the effectiveness of the new design In documenting the outcomes of the test, an organization
than simply observing whether an adverse occurrence hap- might use several different tools, such as flowcharts, cause-and-
pened during the pilot test. effect diagrams, Pareto charts, control charts, scatter diagrams,
and histograms. (See Chapter 5 for complete definitions of
An example of a process measure is number or percentage of these tools.) Chapter 8 provides more information on measur-
individuals over 65 years of age having medication monitoring ing outcomes.
for high-risk drugs that can decrease renal function. The
process measured is medication monitoring of high-risk drugs. The Plan-Do-Study-Act (PDSA) Cycle
An example of an outcome measure is percentage of individ- The analysis, testing, implementation, and monitoring of a
uals at risk for skin breakdown who actually experience skin process are all linked, and a problem identified in one phase
breakdown. 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
In developing measures for pilot tests, the FMEA team should consider using a quality improvement tool such as the PDSA
answer the following questions: cycle. A well-established process for improvement that is based
How will we measure whether the change is successful in on the scientific method, the PDSA cycle (also called the
preventing future failure? (Select the indicators.) PDCA cycle, with the word check replacing the word study) is
What will be measured? (Define the data elements.) attributed to Walter Shewhart, a quality improvement pioneer
Who will perform the measurement? (Define the data col- with Bell Laboratories in the 1920s and 1930s, and is also
lection process.) widely associated with W. Edwards Deming, a student and
With what frequency will the measurement be performed?
123
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

Develop or design a new process or redesign or for testing?
improve an existing process Is there knowledge-based information (for example,
Determine how to test the new or redesigned from the literature, other organizations, or other
process external sources) supporting the new or improved
Identify measures that can be used to assess the process?
success of the strategy and whether the objective
What issues in the external environment (such as
was reached
economy, politics, customer needs, competitors, reg-
Determine how to collect the measures of success
ulations) will affect the performance of the new or
Involve the right people in the development and
improved process?
testing
What issues in the internal environment will affect
The data intended for collection are available
the performance of the new or improved process?
Results can be reported in a way that is useful to
Who is (are) the customer(s) of the process?
the organization and other interested customers
What is the current process?
What is the desired process?
Do
Run the test of the new or redesigned process, Who are the suppliers of the process?
preferably on a small scale What changes will have the most impact?
Collect data on the measures of success Is there a plan for testing the design or improve-
ment?
Study Is there a time line for testing?
Assess the results of the test What data will be collected to determine whether
Determine whether the change was successful the test was successful (that is, whether the objective
Identify any lessons learned was met)?
How is it determined that the measures actually
Act address the desired issue?
Implement the change permanently Can the measures used actually track performance?
or How will data be collected?
Modify it and run it through another testing cycle Who will collect data?
or Are systems in place to support planned measure-
Abandon it and develop a new approach to test
ment?
Is benchmarking feasible for this initiative?
Are the right people involved?
later a colleague of Shewhart. Deming made the PDCA cycle
What resources are needed to design or redesign the
central to his influential teachings about quality. The cycle is
process? What resources are available?
compelling in its logic and simplicity.
The plan-do-study-act (PDSA) approach to performance and operation. The list of proposed improvement actions should
quality improvement includes identifying design or redesign be narrowed to a number that can be reasonably testedper-
opportunities, setting priorities for improvement, and imple- haps between two and four.
menting the improvement project.
During the planning stage, several issues should be resolved:
During the plan step, a team creates an operational plan for Who will be involved in the test?
testing the chosen improvement actions. Small-scale testing What must they know to participate in the test?
can help to determine whether the improvement actions are What are the testing timetables?
viable, whether they will have the desired result, and whether How will the test be implemented?
any refinements are necessary before putting them into full Why is the idea being tested?
124
Sidebar 7-3. Key Questions to Consider Sidebar 7-4. Key Questions to Consider
During the Do Stage During the Study Stage
Was the testing plan followed?

Were needed modifications discussed with the appro- How will the test data be assessed?
priate people? What process should be used?
Was data collection timely? Who should be involved in data analysis?
Was data collection reliable? 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?
What are the success factors? Does data analysis lead to an understanding of prob-
How will the process and outcomes of the test be meas- lem areas?
ured and assessed? Is data analysis timely? Are the results available soon
enough to take needed actions?
The do step involves implementing the pilot test and collect- Do the test data indicate that the design or improve-
ing actual performance data. ment was successful?
What lessons were learned from the test?
During the study (or check) step, data collected during the What measures will determine whether to implement
pilot test are analyzed to determine whether the improvement the tested design or improvement on a permanent
action was successful in achieving the desired outcomes. To basis?
determine the degree of success, the team compares actual test How and to whom will the results of assessment activ-
performance to desired performance targets and baseline ities be communicated?
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 stan- Sidebar 7-5. Key Questions to Consider
dard operating procedure. The process does not stop here. The During the Act Stage
team continues to measure and assess the effectiveness of the
action to ensure that improvement is maintained. Should changes be recommended to others (for exam-
ple, for purchasing equipment or implementing specif-
The components of the four-step PDSA cycle as they relate to ic processes)?
designing and improving processes appear in Sidebar 7-1, page How will these changes be communicated to the
124. A single initiative can involve a number of different test- appropriate people?
ing phases or different change strategies and can there Is any education or training needed?
fore require the use of consecutive PDSA cycles. How will gain be maintained and backsliding be pre-
vented?
To help teams and individuals involved in design or improve- What measures should be used to assess the perform-
ment initiatives apply the method effectively, the organization, ance of the new or improved product or process?
depending on the nature of the improvement project, might Should any of the measures identified here be included
want to consider the questions outlined in Sidebars 7-2 in ongoing measurement activities?
through 7-5, pages 124125, at each step of the method.
Now that the redesigned processes have been created, Chapter

8 will teach you how to implement them and monitor their
performance.
125
References
1. Spath P: Home study program: Using failure mode and effects
2527, May 2003.
3. Joint Commission Resources: Taking care not to introduce new risk
in redesigns. The Joint Commission Benchmark 4:8, Nov. 2002.
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).
126
Chapter 8
Implementing and
Monitoring the New
Process Step 1
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
assemble a team.
change into ongoing health care processes.

Step 2
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 process1:
The first action is to establish a sense of urgency about the needed
redesign. This can be accomplished by identifying the best prac- Step 3
tice and the gap between the organizations process and the best- Brainstorm potential failure modes
practice process, identifying the consequence of being less than and determine their effects.
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 with- Step 4
in this group, and establishing a shared goal about the need for Prioritize failure modes.
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. Step 5
The fourth action is to communicate the changed design in a way
that is simple, works in multiple forms, involves doing instead of modes.
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, Step 6
department by department, or discipline by discipline, as appro- Redesign the process.
priate.
The fifth action is to empower broad-based action by communi-
cating a sensible vision to employees involved in the redesign
process, making organization structures compatible with action, Step 7
providing needed training, aligning information and human Analyze and test the new process.
resources systems, and confronting supervisors who undercut
redesign change.
The sixth action is to generate short-term wins by fixing the dates Step 8
of certain components of the process redesign, doing the easy tasks Implement and monitor the
first, and using measurement to confirm process change. redesigned process.
The seventh action is to consolidate gains and produce more
change by identifying true interdependencies and smooth inter-
127
Case Study

Step 8: Implement and monitor the new process.
The FMEA team met frequently when the changes were rst 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 specically 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 Measuring and Monitoring

identifying linked subsequent cycles of change.
As an FMEA team implements a redesigned process, it also
The eighth and final action is to anchor new approaches in
implements the measurement or monitoring plan it developed
the culture with results, conversation, turnover, and suc-
during the pilot testing stage. Continued monitoring and
cession.
measurement helps to ensure that the desired level of perform-
ance of the redesigned process or subprocess will be main-
Implementing the New Process tained. It also answers the questions How is the new or
How do FMEA teams implement the redesigned process?
revised process working? and What impact, if any, is it hav-
They take those actions outlined above. In addition, they
ing on the larger processes of which it is a part? Effectiveness
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 Strategies for Creating and Managing
implementing the overall redesigned process and each compo- the Change Process
nent redesign step. They define the major milestones and their Establish a sense of urgency
respective completion dates, the person responsible for each Create a guiding coalition
step or milestone, and the person responsible for any corrective Develop a vision and strategy
actions that may be needed. They identify barriers to change Communicate the changed vision
and countermeasures to overcome such barriers. Once all of Empower broad-based action
these activities are performed, the team begins the implemen- Generate short-term wins
tation process. Consolidate gains and produce more change
Anchor new approaches in the culture
128
Chapter 8: Implementing and Monitoring the New Process
Case Study
Amerikan Hastanesi
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 rst column served as a reminder of
the order of the steps in the overall process.
Order Process Prioritized What Can Be How Will Performance

Main Causes
Rank Step Failure Modes Improved? be Monitored?
The concept of emer-

gency pertains only to
the medications found in
the emergency bags and
emergency carts on hos-
pital floors; urgent draw-
1. Clarification ers have been developed
of emer- for medications meant to
Mix-up of concepts gency- increase the quality of
of Emergency urgent con- patient care and satisfac-
Porter leaves An emergency
and Urgent. cepts tion on the floors. This
4 order at the order is left for
Non-detection of 2. Informing will reduce errors due to
Pharmacy. later.
state of emer- employees rapid preparation of med-
gency. 3. Transition to ications in the prepara-
pneumatic tion stage (Plan No.
system 1.PL.6140.001
"Medications
Management Plan" has
been added).
Pneumatic system has
begun to be implement-
ed.
(continued)
measures include both outcome and process indicators, as have various experts who can help design measurement activi-
described in Chapter 7. ties, including experts in information management, quality
improvement, and the function to be measured. The team can
The FMEA team is usually responsible for designing and carry- request the input of these individuals on an ad hoc basis.
ing out the measurement activities that are necessary to deter- Information management, quality improvement professionals,
mine how the redesigned process performs. Organizations may and those responsible for carrying out the process being meas-
129
Case Study
Amerikan Hastanesi, continued
Order Process Prioritized What Can Be How Will Performance be

Main Causes
Rank Step Failure Modes Improved? Monitored?
1. Daily division of labor has

1. Setting up a divi- started to ensure that
sion of labor bul- Pharmacist is not distracted
letin board during medication preparation
2. Separating work stage
spaces at the 2. Common work spaces for
Pharmacy drug preparation in the
3. The Pharmacys Pharmacy increases the risk
contacting the of mix-ups. A separate work
floors first space has been developed
Confusion in
4. Sending out for each Pharmacist.
division of labor
reminders or e- 3. Employees have been
Heavy telephone
mail for timely informed that the Pharmacist
traffic
requests of nar- must first contact the person
Divisions stem-
cotics concerned in inappropriate
ming from
5. Encouraging the situations
Technicians
accompanying 4. Employees have been
training
of Physicians on informed about placing timely
Carrying out all
Orders patient visits. requests for narcotics
procedures at
are con- Adding this to 5. Accompanying Physician on
Wrong medica- the same desk
trolled and the employees patient visits is a performance
tion is given Narcotics not
5 prepared performance indicator that is recorded on
(dosage, mode, being requested
by evaluation sys- each floor
name, formula) promptly
Pharmacy tem. 6. As of May 25, 2008, an intra-
Magistral med-
staff 6. Pharmacy orien- departmental orientation pro-
ications not
tation program gram has begun to be imple-
being requested
7. Contacting the mented in the Pharmacy
promptly
Physician in the department
Illegible order
event of an 7. Employees have been
Placing returned
incomplete informed that criteria for
medication on
order. accepting orders have been
wrong shelf
8. Checking and determined and that each
Incomplete writ-
arranging order is to be checked upon
ing out of order
shelves where arrival at the Pharmacy;
medication is Physicians to be contacted in
stored at the the case of inappropriately
Pharmacy to submitted orders
improve visual 8. Incorrectly dispensed medica-
display and tions (2007April 2008) have
make high-risk been determined and the
medications storage areas and packages
stand out at the Pharmacy have been
checked
130
Case Study
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 weve had reduced rates of patients being dangerously over-
sedated and needing to be in the ICU, says Allen W. Burton, M.D. Were not sure yet if this is a short-term observation
or if its a long-term change. We dont have a signicant amount of long-term data. We need more data. Were also still
working on developing some metrics, and were looking at ways to measure some things that seem a little more
intangible. For example, were 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 Change 7-day ASO to 30- No reported omission errors
to automatic stop order day ASO for Schedule II Short term involving opioids since
(ASO) Controlled Substances September 2008
Education Before
Promote use of comprehen-
Suboptimal patient involve- Medication Patient Safety
sive Patient Home Short term
ment in medication histories Campaign launched
Medication List
October 2008
Develop electronic prompt

Suboptimal medication rec-
to increase accuracy of Short term Prompt went online
onciliation by clinicians
medication reconciliation
Revised and implemented

Confusing epidural and order sets online, that
patient-controlled analgesia Revise order sets Short term included more clear and
order sets concise medication
contraindications
Presentation at Clinical
Orient current staff to real- Managers Forum
Lack of electronic medica- Short term
time Pharmacy folder in Faculty Road Show
tion administration record Long term
electronic record Researching EMR capabili-
ties
Lack of computerized Researching CPOE

Implement CPOE Long term
order entry capabilities
131
Case Study
Gaylord Hospital
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 hospitalsalthough
theyve 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 were seeing has increased again. Now patients are staying for many months and
requiring mechanical ventilation for more time, signicant diagnostic testing, and compressor therapy. Along with
that goes the higher rate of skin breakdown.
Currently, the hospitals pressure ulcer prevalence rate is about 8%, which is still signicantly 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.
40
35
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132
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 fol-
lowing steps are involved in creating a Gantt chart:
1. Agree on start and stop dates for the project and outline the projects 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 Have we designated a key point for information dissemi-
involved will vary widely, depending on the specific organiza- nation?
tion, the function being measured, and the measurement
process. Analyzing Data
After data are collected as part of measurement, they must be
A team that is on track with their efforts to measure the effec- translated into information that the FMEA team can use to
tiveness of redesign initiatives should be able to answer the fol- make judgments and draw conclusions about the performance
lowing questions affirmatively: of the process redesign. This assessment forms the basis for fur-
Do we have a plan for use of the data? ther actions taken with, or modifications of, the redesign
Are the data collected reliable and valid? effort. Numerous techniques can be used to assess the data col-
Have we planned for ease of data collection? lected. Most types of assessment require comparing data to a
Have we defined key elements required for improvement? point of reference. These reference points may include, but are
Are we avoiding a data rich/information poor syn- not limited to, the following:
drome? Internal comparisons
133
Case Study

Laboratory Test Ordering Process: Miami Valley Hospital
Past failures in this area were anecdotal; the organization didnt have any formal data on the lab/neonatal intensive
care unit inefciencies. Since the changes, the number of such problems annoted has been signicantly reduced. As
of the third quarter of 2007shortly after the redesigned processes were put into placeno 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 One method of comparing performance is benchmarking.

Practice guidelines/parameters Although a benchmark can be any point of comparison, most
Desired performance targets, specifications, or thresholds often it is a standard of excellence. Benchmarking is the process
by which one organization studies the exemplary performance
Internal Comparisons of a similar process in another organization and, to the greatest
For internal comparisons, a team can compare its current per- extent possible, adapts that information for its own use.
formance with its past performance by using tools such as run
charts, control charts, and histograms. These are helpful in While benchmarking can be very valuable, it is important for
comparing performance with historical patterns and assessing organizations to give special consideration to what is bench-
variation and stability. They show changes over time, variation marked and how data are interpreted.2 When determining
in performance, and the stability of performance. sources against which to benchmark, an organization should
make sure that the definitions of data to be collected are the
External Comparisons same; otherwise, the organization is not comparing apples to
Assessment is not confined to information gathered within the apples. Data can also be deceiving and in fact can actually
walls of a single organization. To better understand its level of paint a picture of a problem when there is not one. Consider
performance, an organization can compare its performance an organization whose data reflect a high number of problem-
against reference databases, professional standards, trade associ- atic incidents. Some organizations may have more sophisticat-
ation guidelines, and other sources. ed cultures of reporting than others, so the higher numbers
might not necessarily mean the organization has more prob-
The FMEA team can also compare the organizations perform- lematic incidents; it may merely reflect the open reporting of
ance with that of other organizations. Expanding the scope of the culture. Likewise, an organization with a low number of
comparison helps an organization draw conclusions about its incidents does not necessarily have more effective safety
own performance and learn about different methods to redesign processes.
and implement redesigned processes. Aggregate external data-
bases take various forms. Aggregate, risk-adjusted data about Practice Guidelines or Parameters
specific indicators help each organization set priorities for Practice guidelines or parameters, critical pathways, and other
improvement by showing whether its current performance falls standardized care procedures are very useful reference points
within the expected range. for comparison. Whether developed by professional societies
134
Sidebar 8-1. Six Sigma
One commonly used, proactive approach to reducing of the project, and a timeline for project completion.
error is Six Sigma, a quality improvement method devel- 2. Measure. This phase uses flowcharts, cause-and-effect
oped by the manufacturing industry that aims to get as diagrams, and other quality improvement tools to col-
close to zero defects as possible. This methodology lect data and identify or measure contributions to a
focuses on enhancing reliability in processes and was process that can cause problems.
heavily inspired by decades of other quality management 3. Analyze. This phase requires teams to analyze the data
programs such as Quality Control, Total Quality to see how a process is currently being performed and
Management, and Zero Defects. Sigma is another word identify potential areas of failure. This stage also
for standard deviation. The higher the sigma number, the involves determining how potential issues should be
fewer the defects. At Six Sigma, the level of defects is 3.4 addressed and how difficult it will be to address them.
in 1 million. As a comparison, most companies operate at
4. Improve. In the improvement phase, teams must show
around three or four sigma. Six Sigma methodology is a
evidence-based improvement as a result of implement-
data-driven, problem-solving approach based on the idea
ed ideas.
that if you can measure how many defects are in a
5. Control. In this phase, any improvements are sustained.
process, you can then figure out how to eliminate them
in a systematic way. A defect can mean you are failing to
meet a customers needs. In health care, this customer Six Sigma helps organizations do the following:
may be a patient, client, resident, a family, or a staff Identify what is most important to the customer
member. See Sidebar 8-2, page 136, for an example Six whether the customer is the individual receiving care,
Sigma project cycle. Six Sigma relies heavily on statistical staff, or leadership of an organization.
analysis of data. The following are the five basic steps Identify process defects.
involved in the methodology: Measure process defects versus opportunities.
1. Define the problem. This step involves identifying the Eliminate process defects.
project, the goals and objectives of the project, the cur-
Yield sustainable change through process design.
rent knowledge about the project, the business benefits
Sources: Six sigma gives leaders tools for improving processes in OR. OR Manager 20:1315, Jun. 2004; Six sigma success: 100%
compliance in 3 months. Healthcare Benchmarks Qual Improv pp. 5255, May 2004.
or in-house, these procedures represent expert consensus about In addition, other commonly used methods of error reduction
the expected practices for a given diagnosis or treatment. that are used in many industries include Six Sigma, Lean
Assessing variation from such established procedures can help Management, and Robust Process Improvement, a process
a team identify how its process varies from the norm. improvement methodology used by The Joint Commission
that combines Six Sigma and Lean Management. Sidebars 8-1,
Desired Performance Targets 8-2, 8-3, and 8-4, pages 135138, describe these strategies in
A team may establish targets, specifications, or thresholds for more detail.
evaluation against which it compares current performance.
Such levels can be derived from professional literature or Results
expert opinion within the organization. The following are results that some organizations have
discovered after analyzing processes post-FMEA:
If the redesign is not achieving its goals, modifications may Massachusetts General Hospital, a 900-bed urban aca-
need to be made. The FMEA team needs to circle back to demic medical center, conducted a FMEA in its radiology
confirm root causes of the failure, identify a risk-reduction department to improve screenings for patients with dia-
strategy, design an improvement, implement the redesign, and betes before interventional procedures and safety monitor-
measure the effectiveness of that redesign over time. ing of inpatients during weekend hours. Six months after
135
Sidebar 8-2. Example Six Sigma Project Cycle
An integral part of the Six Sigma methodology is Define, Analyze

Measure, Analyze, Improve, Control, also called DMAIC. Analyze the system or process to eliminate any gaps between
DMAIC provides a useful framework for conducting Six the current performance of the process and the desired goal.
Sigma projects and is sometimes used for project control for Analyze current performance.
a process or system that is already in place. Criteria for com-
Is the current statistic good or can it be improved?
pleting a particular phase can be defined and the process
Who will help make changes?
can be reviewed to determine if all objectives have been
met. What resources are needed?
What could cause this change to fail?
Define What are the obstacles in completing this project?
Define the goals of the improvement activity. Include at the
top of the goals the strategic objectives of the organization. Improve
The next level should be the operational goals. The project Improve the system or process. Be creative in finding new
level goals might be to reduce the defect level for a particu- ways to do things better. Use project management and
lar process. Obtain goals from direct communication with other management tools to implement the new approach.
the individual receiving care, treatment, or services, project What is the work breakdown structure for this project?
owners, and staff. What activities are necessary to meet goals?
What is the business case for the project? How will we reintegrate the subprojects?
What is the current state of the project or process? Are there any unanticipated consequences?
What will be the future state?
What is the scope of the project? Control
What are the deliverables? Control the new process. Institute the improved process by
What is the due date? modifying policies, procedures, budgets, and other manage-
ment systems. Use statistical tools to monitor stability.
Measure How will we control risk, quality, scope, schedules, cost,
Measure the existing system or process. Establish valid and and changes to the plan?
reliable metrics to monitor progress. Begin by determining What types of progress reports should be sent?
the current baseline, and use descriptive data analysis to How will we assure that the goals were accomplished?
help you understand the data. How will we maintain the progress made?
What are the key metrics?
Are the metrics valid and reliable?
How will we measure progress?
How will we measure success?
136
Sidebar 8-3. Lean Management
Lean management is a method for advancing safety and To grow the teams knowledge of Lean methods and
quality that involves redesigning or designing processes to problem-solving skills through just-in-time training and
achieve reliability through standard work, mitigation, and the experience of the RIE
continuous improvement. Typically, Lean focuses on To effect cultural change over time, with multiple RIEs
speed, elimination of waste, standardization, and flexibili- involving multiple members of the service line.
ty. It involves tapping into the wisdom and motivation of Adherence to standard work and the skills for improve-
the frontline worker to continually learn and improve ment become values and practices that are strengthened
based upon providing value to the customer with the least over time. A learning organization evolves.
amount of waste possible.
For example, a health care organization may want to
A health care organization using Lean principles must improve its process for administering a high-risk medica-
first start with a high-level analysis of the process from tion. First, a team made up of individuals involved in the
the perspective of the population of the processfor process would create a step-by-step map of the process
example, the resident or staff member. The customers and determine which elements warrant a closer review
journey through the process is mapped step by step, from during an RIE. Then during the RIE, the components of
beginning to end. This sequence of process steps is called the process under examination would be standardized and
the value stream, and is recorded in the value stream map. waste eliminated, making the resulting process leaner and
The map is then analyzed, and the sequence of processes more efficient.
is segregated into process groups or chunks, that can
then be improved through a series of rapid improvement
Lean management allows processes to be developed that
events (RIEs). An RIE is a two- to four-day event in
are reliable, safe, and supportive of people in the health
which a process or a component of a process is analyzed
care environment. Waste is reduced, quality is built into
and improved through the work of an integrated team.
the workflow, and efficiencies follow. Health care organi-
zations that provide the leadership commitment to these
The RIE serves the following purposes: methods are experiencing success by improving safety and
To improve and standardize a particular process, reduce supporting their staff in a learning environment.
waste, and improve reliability using Lean principles
implementation, data showed a 54% reduction in the Participants in a medication administration FMEA at
number of patients not properly checked in for proce- Maine Medical Center reported that in addition to
dures and a 92% reduction of patients left unattended patient safety improvements, they also felt improved sat-
in the hallway.3 isfaction with the decision-making process. They felt that
After conducting an FMEA on its near-infrared analyti- they owned the decisions and were committed, as a
cal procedure for screening drugs, a Netherlands-based group, to positive change. In addition, they became more
public health laboratory performed another risk analysis aware of the way organization processes work together.6
to measure the success of the redesigned processes. On St. Louis Childrens Hospital conducted a FMEA to
recalculating the risk priority numbers, the team found review the process for pediatric chemotherapy adminis-
that the six failure modes they addressed all saw risk tration. After implementation of redesigned processes,
reductions of 50% to 80%.4 the prescribing error rate was reduced from 23% to 14%,
Ashwini Kidney & Dialysis Centre, based in Nagpur, and use of preprinted standard order sets increased from
India, conducted an FMEA to review the hemodialysis 22% at the 2001 baseline, to 45% in 2003 (one year after
process. When they recalculated the risk priority numbers the FMEA was conducted), and 76% in the 2005 follow-
four months after redesigning processes, the seven failure up. Dispensing and administration errors also decreased.7
modes had reductions in risk of 50% to 90%.5
137
procedures manual. Documentation provides a tool with

which to educate staff about the process redesign. It also
Sidebar 8-4. Robust Process
provides a tool that can be used in the future to explore
Improvement
the need for further process change.
Robust Process Improvement (RPI) is The Joint 2. Training, retraining, and competence assessment. With sup-
Commissions enterprise-wide systematic methodolo- port provided by leaders, the team ensures that staff are
gy for improving processes that seeks to continuously trained and retrained as necessary about the process
increase the quality and efficiency of products and redesign, how to perform the steps of the new process,
services. The successful adoption of RPI techniques and links between the steps. Competence assessment
can produce substantial improvements in the quality must be regular and ongoing to ensure that staff maintain
of processes and products, as well as more consistent the skills necessary to maintain the redesigned process.
and effective customer service. 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
RPI consists of a set of strategies, tools, methods, and process being redesigned.
training programs aimed at achieving the following: 3. Ongoing monitoring. The team must maintain vigilance
Recognizing and seeking the voice of the customer about monitoring the redesigned process. This requires
Defining factors critical to quality ongoing access to information about how the redesigned
Using data and data analysis to design improve- process is operating. It also requires regular feedback to
ment everyone involved in the implementation of the new
Enlisting stakeholders and process owners in creat- process. The lack of occurrence of a sentinel event or an
ing and sustaining solutions adverse occurrence after a month or a year is not suffi-
Eliminating defects and waste cient evidence of process redesign success. Remember,
the reason for making changes in the first place was to
Drastically decreasing failure rates
reduce the likelihood of an infrequent adverse outcome.8
Simplifying and increasing the speed of processes Ongoing monitoring of the redesigned process can be
Partnering with staff and leaders to seek, commit integrated into the organizations overall performance
to, and accept change improvement program.
The essential ingredient for the teams success with each of

these activities is leadership support. Leaders must provide the
Sustaining the Redesigned Process support needed to bring change in the form of process redesign
The final step for the FMEA team is to establish and imple- directed at reducing harm to individuals. They must set the
ment a plan to monitor the improvements ongoing effective- tone for a culture that supports safety and pursues a preventive
ness. The goal is to maintain the redesigned process over time. approach to failure reduction. The culture must be a nonpuni-
Continuing education and reinforcement of new desired tive one. Designing or redesigning for safety means making it
behaviors are key here. Organizations frequently falter when difficult for humans to err. However, leaders must recognize
continued measurement indicates that improvement goals are that failures will occur and that recovery or correction should
not being sustained. More often than not, efforts tend to probe built into health care processes so that individuals can take
vide short-term rather than long-term improvement. corrective actions and thereby prevent harm. FMEA provides
How can an organization ensure that a redesigned process is a systematic process for doing so. It focuses on the process of
maintained over time? Three activities performed by teams redesigning potentially problematic processes to prevent the
with leadership support are as follows: occurrence of failures, to increase their detectability, or to mit-
1. Documentation. The team must thoroughly document the igate the effect of a failure that does reach the individual being
new process. This means providing both a graphic and served. To achieve success with FMEA, leaders must provide
nongraphic description of how the redesigned process their complete and unflagging support.
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
138
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 11:4952, May 2004.
3. Abujudeh H.H., Kaewlai R.: Radiology failure mode and effects
analysis: What is it? Radiology 252:544550, Aug. 2009.
4. van Leeuwen J.F., et al.: Risk analysis by FMEA as an element of
analytical validation. J Pharm Biomed Anal 50:10851087, 2009.
5. Ookalkar A.D., Joshi A.G., Ookalkar D.S.: Quality improvement in
haemodialysis process using FMEA. Int J Qual Reliability Manag
26:817830, 2009.
6. Riehle M.A., Bergeron D., Hyrks K.: FMEA and medication
administration. Nurs Manag 2833, 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 32:161166, Mar.
2006.
2527, May 2003.
139
140
Index
A Gaylord Hospital pressure ulcer prevention initiative, 29, 97,

Abbreviations, 27 106, 120, 132
Action plan matrixes, 115 Health Care for the Homeless psychosocial assessment
Affinity diagram, 5153, 8283, 85 completion process, 49, 6768, 77, 109, 123, 128
Airline industry, 19 interventional pulmonology program FMEA example, 65
Amerikan Hastanesi (American Hospital) medication request process Maine Medical Center medication administration process, 137
case study, 32, 5859, 7172, 92, 110111, 121122, 129130 Massachusetts General Hospital diabetes screening process, 135,
Analysis and testing of redesigned process, 119125 137
data collection strategies, 123 Miami Valley Hospital neonatal intensive care unit laboratory
documentation of outcomes of tests, 123 test ordering process, 26, 4344, 73, 9091, 105, 118, 134
examples of, 118, 119, 120, 121122, 123 Netherlands-based laboratory near-infrared analytical procedure,
paper testing, 120 137
pilot testing, 118, 122123 St. Louis Children's Hospital pediatric chemotherapy
Plan-Do-Study-Act (PDSA) cycle, 123125 administration process, 137138
simulation, 120, 122 University of Texas M.D. Anderson Cancer Center opioid
Anesthesia equipment, 106 prescribing process, 35, 5152, 63, 83, 107, 119, 131
Antibiotic therapy process, 33 Cause-and-effect (fishbone) diagrams, 83, 8687, 115, 123
Ashwini Kidney & Dialysis Centre hemodialysis process, 137 Change analysis, 83, 85, 88
Assessment checklists, 104105 Change and performance improvement, structures to manage
Associations and organizations, professional, 32, 101, 134 (LD.03.05.01), 11
Chemotherapy administration process, 137138
B Clients. See Patients, clients, and customers
Backup processes, 103104, 119 Clinical practice guidelines and clinical pathways, 5, 103, 104,
Benchmarking, 134 134135
Brainstorming process, 48, 50, 55, 82, 115, 120 Communication
Building design, FMEA use for, 28, 30 of changed process, 118119, 127
documentation as, 106107
C hierarchical cultures and, 28
Canister gas processes, 114 processes related to, root cause analysis of, 78, 79, 81
Cascade of failures, 2627 safety and quality of care, communication of information related
to (LD.03.04.01), 1011
Case studies and examples
with staff
Amerikan Hastanesi (American Hospital) medication request
International Patient Safety Goals, 4
process, 32, 5859, 7172, 92, 110111, 121122, 129130
quality improvement and patient safety program, 4
Ashwini Kidney & Dialysis Centre hemodialysis process, 137
safety and quality of care information, 1011
computerized medication systems
standardization of, 103
design or redesign of to reduce errors, 102, 104, 105
team-based approach to care and, 22
fail-safe designs, 64
verbal orders
workarounds and potential failures, 5455
histogram examples, 94
diabetes screening process, 66, 87, 135, 137
read-back of, 103
Computerized medication systems
141
Toolkit for Preventing Health CareAssociated Infections
design or redesign of processes, 102, 104, 105, 106107, 109 flowcharts (see Flowcharts [process maps])
fail-safe designs, 64 process for, 41
workarounds and potential failures, 5455 walking through the process, 4647
Concentrated potassium, 106 Dialysis process, 137
Constraints (forcing functions), 106 DMAIC (Define, Measure, Analyze, Improve, Control), 136
Control charts, 85, 88, 89, 123, 134 Documentation
Critical pathways and clinical practice guidelines, 5, 19, 103, 104, of analysis and testing of redesigned process, 123
134135 communication through, 106107
CRM (Crew Resource Management) program, 19 of new process, 138
Culture of safety, 1, 138 Drug dosages, abbreviations for, 27
Customers. See Patients, clients, and customers
E
D Electrical power supply, 103
Data collection and analysis. See also Performance measurement data Electronic medical records, 104
analysis requirement (PI.02.01.01), 1617 Environmental management
benchmarking, 134 environmental factors, failures related to, 77
collection requirement (PI.01.01.01), 1316 processes related to, root cause analysis of, 78, 79, 81
comparisons made during analysis (QPS.4.2), 7 Equipment
criteria for, 82 fail-safe designs, 105106
data and information to guide decisions (LD.03.02.01), 10 failures related to, 77
external comparisons, 134 new equipment, FMEA of, 28
FMEA and, 24 processes related to, root cause analysis of, 78, 79
frequency of analysis (QPS.4.1), 7 Event lines, 45
during implementation of redesigned process, 128129, Event-tree (fault-tree) analysis, 23, 88, 9293
133135
individual responsible for (QPS.4), 7 F
internal comparisons, 134 Facility design, FMEA use for, 28, 30
measures Fail-safe designs, 64, 105106
choosing what to measure, 82 Failure mode and effects analysis (FMEA)
definition of, 80 barriers to effective use of, 23, 24, 36
outcome measures, 117, 123, 128129 basis for, 19
process measures, 123, 128129 benefits of, 3, 19, 20, 22
performance improvement data, 30 definition of key words, 1
strategies for, 123 effectiveness of, 2, 3, 19
tools and techniques for (QPS.4), 7 goal of, 20
trends and variations, analysis of (QPS.7), 8 leadership responsibilities during, 28
Data validation leadership support for, 2223, 138139
independent third-party validation process (QPS.5.1), 8 limitations of, 2223
internal process for (QPS.5), 78 pitfalls to, 23, 24
Decision-tree analysis, 66 process for, 23, 1920, 21 (see also specific steps in process)
Define, Measure, Analyze, Improve, Control (DMAIC), 136 purpose of, 12, 19
Diabetes screening RCA compared to, 20
cause-and-effect (fishbone) diagram of, 87 scope of, 33, 3639
hazard analysis and decision-tree analysis, 66 skepticism about, 12
Massachusetts General Hospital diabetes screening process, 135, success of, 2324
137 system and process design and, 20, 22
Diagramming a process team for (see Team for FMEA)
common mistakes, 4546 time and labor needed for, 23, 33
complexity of process and, 33 use of during RCA, 20
differences between intended and actual process, identification worksheet to track progress, 5657
of, 42, 50 Failure modes
event lines, 45 active failures, 50
examples of, 43, 46, 47, 49, 5152, 58 categorizing ideas, 5053, 8283
142
Index
consensus of team members on ratings, 6970 steps for creating, 45

criticality of symbols for, 42, 45
consensus of team members on ratings, 6970 Forcing functions (constraints), 106
determination of, 6162
definition of, 47 G
detectability of, 6365, 69, 102 Gantt charts, 115, 133
effects of, 53, 55, 64, 114 Gaylord Hospital pressure ulcer prevention initiative case study, 29,
identification of, 4748 97, 106, 120, 132
brainstorming process, 48, 50 Generator, emergency, 103
examples of, 44, 59
resources for, 50 H
risk points, identification of, 50 Health Care for the Homeless psychosocial assessment completion
interrelationships of, 23 process case study, 49, 6768, 77, 109, 123, 128
latent conditions and failures, 27, 50, 76 Hierarchical cultures, 28
low-frequency, high-severity failures, 28 High-risk process
multiple failures, 23 characteristics of, 2528
prioritization of, 23, 61, 69, 7073 risk-reduction strategies, 109, 112, 113
examples of, 63, 6768, 7173 selection of for FMEA investigation, 23, 25, 3233
rating scales, 65 case studies, 26, 29, 32, 35
risk priority number (RPN), 69, 70, 73, 120 external sources to identify process to analyze, 30, 32
probability of occurrence, 6263, 64, 65, 66, 6768, 69 internal sources to identify process to analyze, 30
probability of occurrence, reduction of, 102 standardization of, 102103
proximate causes, 7678 Histograms, 94, 123, 134
rating methods, 65, 69 Human-factor variation, 1, 27, 77
rating scales, 65 Human resources processes, 78, 79, 81
RCA approach to, 7576
in redesigned process, 114 I
risk priority number (RPN), 69, 70, 73, 120 Implementation of redesigned process
severity of actions to lead change process, 127128
determination of, 6263 activities for, 128
examples of analysis, 66, 6768 barriers to implementation, 112, 114, 128
reduction of, 102 change process, strategies to manage, 128
severity scoring scale, 62, 64 communication of changed process, 118119, 127
timing of failure during process and injury to individual data collection and analysis during, 128129, 133135
receiving care, 53 documentation of new process, 138
variation and, 7576 examples of, 128, 129132, 134
common-cause variation, 7576, 78, 88 how to implement, 117118
introduction of through process redesign process, 119120 long-term and short-term plans, 114
reduction of, 88 measurement and monitoring during, 128129, 133
special-cause variation, 76, 78, 88 measurement and monitoring of redesigned process, 138139
workarounds and potential failures, 5455, 105 modifications to redesigned process, 135
Fault-tree (event-tree) analysis, 23, 88, 9293 organizing prior to, 117119
Fetal heart rate monitoring, 103 performance targets, specifications, and thresholds, 135
Financial impact of risks, 32, 80 Plan-Do-Study-Act (PDSA) cycle, 123125
Financial performance, 22 resources for, 128
Fishbone (cause-and-effect) diagrams, 83, 8687, 115, 123 shortcuts and workarounds, 109
Flowcharts (process maps) sustaining redesigned process, 138139
analysis and testing of redesigned process, 120 time frame for, 128
diagramming the process with, 42, 45 when to implement, 118
documentation of outcomes of tests, 123 where will it be implemented, 118
event lines, 45 who is responsible for implementation, 118
examples of, 43, 46, 47, 49, 5152, 58 Infant abduction, risk-reduction strategies, 113
of new process, 138
143
Information management communication of information related to (LD.03.04.01),

FMEA and, 24 1011
processes related to, root cause analysis of, 78, 79, 81 focus of individuals who work in organization on
Infusion pumps, 105106 (LD.03.06.01), 1112
International Patient Safety Goals planning activities to support (LD.03.03.01), 10
communication with staff about (QPS.1.4), 4 Leadership processes, 78, 79, 81
implementation of (QPS.1.2), 4 Lean Management, 137
key measures identification for (QPS.3.3), 7 Liability insurance companies, 32
International Society for Quality in Health Care (ISQua), 2 Loosely coupled processes, 27, 64
Interventional pulmonology program FMEA example, 65 Low-frequency, high-severity errors and failures, 28
Interviews and surveys, 30, 80, 82, 108109, 123 Low-risk processes, 28
ISQua (International Society for Quality in Health Care), 2
IV infusion pumps, 105106 M
Maine Medical Center medication administration process, 137
J Managerial structures, processes, and outcomes, key measures
Joint Commission identification for (QPS.3.2), 6
Leadership (LD) standards and requirements, 1, 2, 1013 Massachusetts General Hospital diabetes screening process, 135, 137
Performance Improvement (PI) standards and requirements, 1, Measures. See Performance measurement data
1318 Medical errors and mistakes
purpose of standards and evaluation methods, 2 active failures, 50
Robust Process Improvement (RPI), 135, 138 cascade of failures, 2627
Sentinel Event Alerts, 30, 32 causes of, 1
Sentinel Event Database, 30, 31 FMEA and, 23
Joint Commission International human failure, 1, 27, 77
accreditation and certification standards, 2 latent conditions and failures, 27, 50, 76
ISQua accreditation, 2 leadership response to, 30
purpose of, 2 near-miss events, identification and analysis of (QPS.8), 8
Quality Improvement and Patient Safety (QPS) standards and reduction of
requirements, 1, 39 continuous process assessment and, 1
Sentinel Event Policy, 30, 33 culture of safety and, 1
FMEA use for, 12, 19, 22
L leadership's responsibility for, 1
Laboratory near-infrared analytical procedure, 137 performance improvement efforts and, 1
Laboratory reports affinity diagram, 85 staff education and training and, 27, 108
Laboratory test ordering process case study, 26, 4344, 73, 9091, reporting systems, 30
105, 118, 134 response to, 1, 108
Latent conditions and failures, 27, 50, 76 Swiss cheese model of error occurrence, 27
Laws and regulations compliance (LD.04.4.01), 1213 Medical records, electronic, 104
Leadership Medication processes
error reduction, responsibility for, 1 case studies and examples
incidents, response to, 30 Amerikan Hastanesi (American Hospital) medication
quality improvement and patient safety program, responsibility request process, 32, 5859, 7172, 92, 110111,
for (QPS.1), 3 121122, 129130
resources for FMEA, 2223, 36 Maine Medical Center medication administration process,
responsibilities of during FMEA, 28 137
support for FMEA, 2223, 138139 outpatient parenteral antibiotic therapy service, 33
team for FMEA, influence of leadership on development of, 36 St. Louis Children's Hospital pediatric chemotherapy
Leadership (LD) standards and requirements, 1, 1013, 20 administration process, 137138
change and performance improvement, structures to manage complexity of, 33
(LD.03.05.01), 11 computerized medication systems
data and information to guide decisions (LD.03.02.01), 10 design or redesign of processes, 102, 104, 105, 106107,
laws and regulations compliance (LD.04.4.01), 1213 109
safety and quality of care fail-safe designs, 64
144
Index
workarounds and potential failures, 5455 redesigning a process, evaluation of redesign elements, 115
drug dosages, abbreviations for, 27 selection of process for FMEA investigation through use of, 30
failure mode effects during, 53, 55 Performance improvement. See also Performance Improvement (PI)
FMEA team example, 34 standards and requirements
hierarchical cultures and, 28 achievement and sustainment of, 8, 2324
medication utilization process, design of, 22 change and performance improvement, structures to manage
reconciliation process flowchart, 47 (LD.03.05.01), 11
risk-reduction strategies, 112 error reduction through, 1
Miami Valley Hospital neonatal intensive care unit laboratory test FMEA as tool for, 20, 22
ordering process case study, 26, 4344, 73, 9091, 105, 118, 134 teamwork initiatives, 109
Multivoting, 9495, 115 timeliness of care and safety, 22
Performance Improvement (PI) standards and requirements, 1,
N 1318, 20
Near-miss events, identification and analysis of (QPS.8), 8 data collection and analysis
Netherlands-based laboratory near-infrared analytical procedure, 137 analysis requirement (PI.02.01.01), 1617
collection requirement (PI.01.01.01), 1316
O improvement opportunities and activities (PI.03.01.01), 1718
Online Extras, 3 Performance improvement data, 30
Opioid prescribing process case study, 35, 5152, 63, 83, 107, 119, Performance measurement data
131 benchmarking, 134
Organizational culture choosing what to measure, 82
barriers to effective use of FMEA, 23, 24, 36 clinical practice guidelines and clinical pathways, 134135
culture of safety, 1, 138 external comparisons, 134
hierarchical cultures, 28 implementation of redesigned process, 128129, 133
processes related to, root cause analysis of, 78, 79, 81 internal comparisons, 134
Organizations and associations, professional, 32, 101, 134 measure
Outcome measures, 117, 123, 128129 choosing what to measure, 82
Outpatient parenteral antibiotic therapy service, 33 definition of, 80
Oxygen canister processes, 114 measure, definition of, 80
outcome measures, 117, 123, 128129
P process measures, 123, 128129
Pain medication management, 22 qualitative measures, 117118
Paper testing, 120 quantitative measures, 117118
Parenteral antibiotic therapy service, 33 as RCA resource, 80, 82
Pareto charts, 30, 70, 73, 9597, 115, 123 Pilot testing, 118, 122123
Patients, clients, and customers Plan-Do-Check-Act (PDCA) cycle, 123
assessment checklists, 104105 Plan-Do-Study-Act (PDSA) cycle, 123125
feedback from, 30, 80, 82 Potassium concentrations, 106
timing of failure during process and injury to individual Practice guidelines and clinical pathways, 5, 103, 104, 134135
receiving care, 53 Preoperative procedures, risk points during, 50
PDCA (Plan-Do-Check-Act) cycle, 123 Pressure ulcer prevention initiative case study, 29, 97, 106, 120, 132
PDSA (Plan-Do-Study-Act) cycle, 123125 Proactive risk assessment
Pediatric chemotherapy administration process, 137138 design of, 23
Performance and quality improvement tools financial savings through, 22
data analysis with, 134 FMEA as tool for, 22
documentation of outcomes of tests, 123 leadership support for, 1
familiarity of of team members with, 36 requirement for, 2
interrelationships of failure modes, understanding of through use standards related to, 1018, 20
of, 23 Proactive risk reduction, 70
Plan-Do-Study-Act (PDSA) cycle, 123125 Processes and systems. See also High-risk process
prioritization of failure modes with, 70, 73 analysis and testing of redesigned process (see Analysis and
for RCA process, 8299 testing of redesigned process)
analysis of after sentinel event, 20
145
change and performance improvement, structures to manage timing of failure during process and injury to individual
(LD.03.05.01), 11 receiving care, 53
clinical structures, processes, and outcomes, key measures variable input, 26
identification for (QPS.3.1), 56 variation in
complexity of, 1, 26, 33, 103, 119 common-cause variation, 7576, 78, 88
continuous process assessment, 1 introduction of through process redesign process, 119120
design of reduction of, 88
according to quality improvement principles, 45 special-cause variation, 76, 78, 88
fail-safe designs, 64, 105106 walking through the process, 4647
FMEA and, 20, 22 Process maps. See Flowcharts (process maps)
premise that nothing will go wrong, 1 Process measures, 123, 128129
risk assessment or redesigned processes, 28 Professional associations and organizations, 32, 101, 134
time needed for, 23 Proximate causes, 7678
diagramming of (see Diagramming a process) Psychosocial assessment completion process case study, 49, 6768,
differences between intended and actual process, identification 77, 109, 123, 128
of, 42, 50
financial impact of risks, 32, 80 Q
hand offs during, 27 Quality Improvement and Patient Safety (QPS) standards and
human-factor variation, 1, 27, 77 requirements, 1, 39, 20
implementation of redesigned process (see Implementation of clinical practice guidelines and clinical pathways, use of
redesigned process) (QPS.2.1), 5
input/output mismatch, 119 clinical structures, processes, and outcomes, key measures
latent conditions and failures, 27, 50, 76 identification for (QPS.3.1), 56
loosely coupled processes, 27, 64 data collection and analysis
loose time constraints, 28 comparisons made during analysis (QPS.4.2), 7
managerial structures, processes, and outcomes, key measures data and information to guide decisions (LD.03.02.01), 10
identification for (QPS.3.2), 6 frequency of analysis (QPS.4.1), 7
redesigning a process individual responsible for (QPS.4), 7
documentation of new process, 138 tools and techniques for (QPS.4), 7
effects of elements of redesigned process, 114 trends and variations, analysis of (QPS.7), 8
evaluation of redesign elements, 109, 112, 115 data validation
examples of, 105, 106, 107, 109, 110111 independent third-party validation process (QPS.5.1), 8
failure modes in redesigned process, 114 internal process for (QPS.5), 78
impact of redesigned elements, 114 improvement and safety activities, priority areas for (QPS.10), 9
importance of, 101 improvement in quality and safety, achievement and sustainment
methodical approach to, 109 of (QPS.9), 8
methods for, 102109 International Patient Safety Goals
modifications to redesigned process, 135 communication with staff about (QPS.1.4), 4
preparations for, 101102 implementation of (QPS.1.2), 4
resources for, 101 key measures identification for (QPS.3.3), 7
strategies for, 102 managerial structures, processes, and outcomes, key measures
sustaining redesigned process, 138139 identification for (QPS.3.2), 6
redundancy, 103104, 119 measurement activities, priorities for (QPS.1.2), 4
risk points, 50 near-miss events, identification and analysis of (QPS.8), 8
selection of for FMEA investigation, 23, 25, 28, 3233 quality improvement and patient safety program
case studies, 26, 29, 32, 35 collaborative approach to (QPS.1.1), 3
external sources to identify process to analyze, 30, 32 communication with staff about (QPS.1.4), 4
internal sources to identify process to analyze, 30 keys measures, identification of (QPS.3 through QPS.3.3),
shortcuts and workarounds, 5455, 103, 105, 109 57
simplification of, 103, 119 leadership responsibility for (QPS.1), 3
standardization of, 26, 102103 priorities for (QPS.1.2), 4
tightly coupled processes, 2627, 28, 64, 107108, 119 staff education and training on role in (QPS.1.5), 4
tight time constraints, 2728 systematic approach to (QPS.1.1), 3
146
Index
technological and other support for (QPS.1.3), 4 failure because of, 75

risk management program (QPS.11), 9 identification of all, 7680, 81
systems and processes, design of (QPS.2), 45 number to identify, 80
Quality improvement tools. See Performance and quality probing for, 78, 99
improvement tools sentinel events and, 75, 76
special-cause variation, 76, 78, 88
R time needed for, 70
Radiation administration tools to help with, 8299
fault-tree analysis diagram, 93 use of during FMEA, 20, 70, 7576
treatment planning process flowchart, 46 RPI (Robust Process Improvement), 135, 138
Rapid improvement events (RIEs), 137 RPN (risk priority number), 69, 70, 73, 120
Rating scales, 65 Run charts, 9798, 134
RCA. See Root cause analysis (RCA)
Redundancy, 103104, 119 S
Regulations and laws compliance (LD.04.04.01), 1213 Safety and quality of care
Reporting systems, 30 communication of information related to (LD.03.04.01), 1011
Restraint use data and information to guide decisions about (LD.03.02.01),
performance measurement data on, 80, 82 10
process team example, 34 focus of individuals who work in organization on
risk-reduction strategies, 113 (LD.03.06.01), 1112
run chart example, 98 planning activities to support (LD.03.03.01), 10
Resuscitation, 34, 102 team-based quality improvement, 2223
RIEs (rapid improvement events), 137 timeliness of care and, 22
Risk management Safety improvement tools. See Performance and quality improvement
financial impact of risks, 32, 80 tools
proactive risk assessment St. Louis Children's Hospital pediatric chemotherapy administration
design of, 23 process, 137138
financial savings through, 22 Scatter diagrams, 9899, 123
FMEA as tool for, 22 Sentinel Event Alerts (Joint Commission), 30, 32
leadership support for, 1 Sentinel Event Database (Joint Commission), 30, 31
requirement for, 2 Sentinel Event Policy (Joint Commission International), 30, 33
standards related to, 1018, 20 Sentinel events
proactive risk reduction, 70 definition of, 1
program for (QPS.11), 9 information about, 3032
risk-reduction strategies, 109, 112, 113 root cause analysis (RCA) and, 75, 76
Risk points, identification of, 50 selection of process for FMEA investigation and, 30
Risk priority number (RPN), 69, 70, 73, 120 statistics on, 30, 31
Robust Process Improvement (RPI), 135, 138 suicide
Root cause analysis (RCA) cause-and-effect (fishbone) diagram of contributing factors,
common-cause variation, 7576, 78, 88 86
criteria for use and truncation of, 99 proximate causes of, 77
effective RCA, characteristics of, 76 risk-reduction strategies, 113
FMEA compared to, 20 systems and processes, analysis of after sentinel event, 20
focus of, 75 types of organizations that can experience, 30
process for, 75 wrong-site surgery investigation Pareto chart example, 96
probing for root causes, 78, 99 Services, new, 28
questioning process, 7680, 99 Shortcuts and workarounds, 5455, 103, 105, 109
proximate causes, 7678 Simulation, 120, 122
requirement for, 20 Six Sigma, 135, 136
resources for, 70, 80, 82 Staff
root causes communication with
characteristics of, 80 International Patient Safety Goals, 4
examples of identification of, 77, 83, 9092, 97 quality improvement and patient safety program, 4
147
safety and quality of care information, 1011 hierarchical culture compared to, 28
competence of, 25, 27, 81, 108, 112, 117, 138 performance improvement initiatives for, 109
feedback from, 30, 80, 82, 108109, 123 team-based approach to care, 22
hierarchical cultures, 28 team-based quality improvement, 2223
selection of process for FMEA investigation and, 33 Technology
Staff education and training assessment checklists, 104105
challenges of introducing new training programs, 108 computerized medication systems
error management principles for, 108 design or redesign of processes, 102, 104, 105, 106107,
error reduction through, 27, 108 109
on FMEA process, 24, 34, 36, 80 fail-safe designs, 64
quality improvement and patient safety program, role in workarounds and potential failures, 5455
(QPS.1.5), 4 electronic medical records, 104
on redesigned process, 138 risk reduction through use of, 104105
response to errors and mistakes, 1 support for quality improvement and patient safety program
Standardization, 26, 102103 (QPS.1.3), 4
Suicide Testing of redesigned process. See Analysis and testing of redesigned
cause-and-effect (fishbone) diagram of contributing factors, 86 process
proximate causes of, 77 Tightly coupled processes, 2627, 64, 107108, 119
risk-reduction strategies, 113 Time
Surveys and interviews, 30, 80, 82, 108109, 123 design of systems and processes, time needed for, 23
Swiss cheese model of error occurrence, 27 for FMEA process, 23, 33
Systems. See Processes and systems loose time constraints, 28
tight time constraints, 2728, 107108, 119
T timeliness of care and safety, 22
Team for FMEA Transfusion processes
assignments for members, 39 failures in, 102
attendance at meetings, 39 redundancy in, 103104
checklist of tips for team success, 36, 37
consensus of team members, 6970 U
debates among members, 23, 39 University of Texas M.D. Anderson Cancer Center opioid prescribing
decision process, 39 process case study, 35, 5152, 63, 83, 107, 119, 131
ground rules for, 39
leadership's influence on team development, 36 V
meeting time, 37, 39 Variation
members of team, 23, 3334 common-cause variation, 7576, 78, 88
case studies, 26, 29, 32, 35 failure modes and, 7576
examples of teams, 34 introduction of through process redesign process, 119120
mission and scope of, 3639 reduction of, 88
opportunities to speak, 39 special-cause variation, 76, 78, 88
resources for, 2223, 36 in systems and processes, 75
roles of members Verbal orders
champion, 36 histogram examples, 94
facilitator, 34 read-back of, 103
process expert, 36
recorder, 34 W
representatives of health care disciplines, 36 Workarounds and shortcuts, 5455, 103, 105, 109
team leader, 34 Worksheets
size of team, 3334 team start-up worksheet, 3739
start-up worksheet, 3739 worksheet to track FMEA progress, 5657
training and qualifications of team members, 24, 34, 36, 80 Wrong-site surgery investigation Pareto chart example, 96
Team-oriented culture
error reduction through, 108109
feedback on teamwork interactions, 108109
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FMEA10 cover_8.

5 x 11 Template 6/2/2010 4:03 PM Page 1

About Joint Commission Resources

About Joint Commission International

Joint Commission Resources Mission

Joint Commission International

2010 by The Joint Commission

Printed in the U.S.A. 5 4 3 2 1

About This Book

Chapter 1. Failure Mode and Effects Analysis Overview

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

Chapter 3. Diagramming the Process and Brainstorming Potential Failure Modes

Chapter 4. Prioritizing Failure Modes

Chapter 5. Identifying Root Causes of Failure Modes

Chapter 6. Redesigning the Process

Chapter 7. Analyzing and Testing the Process

Chapter 8. Implementing and Monitoring the New Process

A re errors in care, treatment, and services still attributed to

Joint Commission International How to Use This Book

Table A-1. Joint Commission International Standards and Requirements

Quality Improvement and Patient Safety Chapter Standards and Requirements

Table A-1. continued

Standard QPS.1.5 Staff are trained to participate in the program.

Table A-1. continued

e) Considers relevant risk management information

Table A-1. continued

Table A-1. continued

Standard QPS.5 The organization uses an internal process to validate data.

Table A-1. continued

Table A-1. continued

Standard QPS.9 Improvement in quality and safety is achieved and sustained.

Leadership Chapter Standards and Requirements

Table A-2. continued

3. Communication is designed to meet the needs of internal and external users.

Table A-2. continued

There are no lapses in quality control and proficiency testing.

Standard LD.04.04.01 The organization complies with law and regulation.

Table A-2. continued

Applicable to the ambulatory care program:

Performance Improvement Chapter Standards and Requirements

Table A-2. continued

Table A-2. continued

Table A-2. continued

Applicable to the home care program:

Standard PI.02.01.01 The organization compiles and analyzes data.

Table A-2. continued

Standard PI.03.01.01 The organization improves performance on an ongoing basis.

Table A-2. continued

Applicable to the ambulatory care program:

Failure Mode and Effects

A Step-by-Step Approach to FMEA Step 3

The FMEA technique is based on long-studied engineering principles

dimensions of an organizations performance. For example, use Improve Financial Performance

Conducting FMEA on the Neonatal Intensive Care Unit

Step 1: Select a high-risk process.

Step 2: Assemble the team.

Lack of supervision Transfer guidelines

Improper ventilation technique

between process steps is tightened even in an otherwise

Step 1: Select a high-risk process.

Step 2: Assemble the team.

(HEPA) Filter systems

Table 2-1. Sentinel Event Statistics