Root Cause Analysis and

Failure Mode and Effects

Analysis
 Learning Objectives

• Discuss the utility of the root cause analysis

(RCA) process in health care
• Describe the steps of performing a failure mode
and effects analysis (FMEA) in a health care
setting
• Explain the benefits of drawing from a
multidisciplinary team to complete these
evaluations
 RCA of Medication Errors
• Analytically identifies critical underlying reasons for the
occurrence of an adverse event or close call (near miss)
• Answers these questions:
– What happened?
– Why did it happen?
– What usually happens?
– What should have happened according to policies and procedures?
– What will prevent it from happening again?
– What actions need to be taken?
– How will outcomes be measured?
• Any event has multiple root causes
– Evaluating root causes can lead to changes that will break the chain
of events and avoid the final breakdown
 RCA of Medication Errors

• Can be applied to one event or a series of

events
• Involves:
– Presenting data clearly
– Generating practical recommendations
– Implementing appropriate corrective action
– Establishing systemic controls to avoid
recurrence
 Consider the Environment
• The reporting environment or culture in the workplace
determines the RCA
• “The medical imperative is clear: To make health care
safe we need to redesign our systems to make errors
difficult to commit, and create a culture in which the
existence of risk is acknowledged and injury prevention is
recognized as everyone’s responsibility.”*
• People will not speak up if:
– They fear punishment
– They are accustomed to unsafe situations
• A nonthreatening environment that fosters an open
culture of reporting errors facilitates RCA
*Leape LL, et al. JAMA. 1998;280:1444–7.
 Steps in RCA

1. Charter the team

2. Document and research
3. Identify root causes
4. Develop actions
5. Establish outcome measures
 Charter the Team
• People
– Multidisciplinary
– Include those versed in the process but not directly involved
with the incident
• Places, tools, and time
– Provide adequate meeting space, computer access, and
time
• Management support
– Brief management
– Obtain written consent for the allocation of assets necessary
to complete the RCA
 Document and Research
• Use the preliminary report to write a description of
the event
• Collect data relevant to the event
– Policies, photographs, equipment involved, etc.
• Interview key participants in the event
• Gather credible references that may assist in
understanding the event
• Rewrite the event description, adding the new
information
 Identify Root Causes
• Create a diagram of the flow of events
– Trace the chronology of events that led to the adverse event or
close call (see Figures 5-1 and 5-2 in the textbook for examples)
– Examine the process to find weaknesses:
• Include what really happened, not what was supposed to happen
• At each step of the event flow ask “Why?”
• Provide the RCA teams with easy-to-use tools to increase the
probability that all teams will be equally rigorous over time
• Table 5-1 illustrates questions for an “initial understanding” that a
team must consider to discover what happened and how to prevent
a recurrence
– Figure 5-3 shows a sample cause-and-effect fishbone diagram for
analyzing events
– Write a concise cause-and-effect statement based on the findings
in the diagram
 Event Flow Diagram of
“Initial Understanding”

• A hospitalized patient was treated with heparin and warfarin

• The patient’s therapy was changed and restarted, and eventually
he experienced fatal bleeding
 Event Flow Diagram of
“Final Understanding”

• RCA team conducted interviews and uncovered several processes

that contributed to the high level of anticoagulation
• The final understanding diagram contains information that was
discovered through investigation of system-level causes
 Fishbone Diagram of
Anticoagulation Events

• The Ishikawa fishbone diagram is used in aggregated RCA of

anticoagulation-related events
• Notations on branches indicate the portions of the process
associated with an adverse event
 Develop Actions
• Team should state the actions members took to address the root
cause(s) of the errors
– Action statement should be readily understood (specific and
concrete)
– Conduct a trial of the actions to address the problems, if possible
– Action statement should have buy-in from process owners
• Goal is to prevent a recurrence of the same close call or
adverse event or at least to minimize it
– Actions should be permanent and physical, not temporary and
procedural
– Actions should not be asking providers to “pay more attention next
time”
– Avoid unnecessary training or new policies
– Table 5-2 in textbook lists examples of actions proposed in RCA
 Establish Outcome Measures
• Include measures for evaluating whether the actions
prevent future events
• Outcome measures should:
– Not only measure whether the action was completed but
whether the action was effective
– Be quantifiable and, when appropriate, include clear
numerators and denominators
– Clearly define the strategies and include the frequency and
time frame for monitoring
– Include a threshold or goal, and ensure it is realistic
 Aggregated RCA
• Some types of events occur fairly often but do not always result in
serious harm
• A facility may not have the resources for individual analysis of
every event, and batch analysis of these events may be
advantageous
• The process for aggregated review is similar to the individual RCA
except a subset of events is chosen for more review and action
planning
• RCA team members often serve for 1 year to provide efficient use
of resources and consistency among analyses
• Aggregated review teams can be more creative in their approach
to the analysis because there is no single event
• Teams should ensure that RCA does not become routine; employ a
variety of tools (e.g., floor plans, diagrams, bar charts)
Aggregated RCA at VHA Facilities
• Aggregated review required for potentially serious events (e.g.,
patient falls, missing patients, parasuicidal events, adverse drug
events)
• VHA determines severity using the matrix shown in Table 5-3
• Key factors in determining severity of events
– Extent of injury
– Length of stay
– Level of care required for remediation
• Actual events with a score of 3 require RCA
• For potential adverse events, severity is assigned on most likely
worst-case systems scenario
• Potential medication events with a score of 3 can be analyzed
individually or in quarterly aggregate RCA
• Visit the Department of Veterans Affairs (VA) Web site for details of
the process: www.patientsafety.gov
 System-Level Vulnerabilities
• Primary tasks of RCA team
– Identify the system-level features and processes
• Ask the correct questions to uncover the causes
• See Table 5-1 of textbook for questions to assess system-level
vulnerabilities
– Shore up systems and processes that contribute to safety
– Eliminate or control those that make things more dangerous
• RCA team can utilize tools efficiently and comprehensively
determine the flow of events
– Revisit the “initial understanding” event flow diagram (Figure 5-1)
• RCA team should state the findings clearly and with sufficient
detail for easy identification of the system-level vulnerabilities
(root causes or contributing factors) that need to be fixed
 System-Level Vulnerabilities

• Helpful guidelines in writing statements about root

causes and contributing factors
– Show cause and effect (e.g., nearly identical packaging)
– Phrase findings to avoid negative statements about people or
things
– Focus on system-level problems, not individual performance
– Get to the norms behind procedural violations
– Remember that failure to act is causal only when there is a
preexisting duty to act
 Human-Factors Engineering
• Human-factors engineering: the study of how people interact and
work successfully with other people and things in their world, and how
to increase success or improve human performance by “designing-in”
physical or environmental cues or processes
• Examples of the actions proposed in RCA using design-in safety
– Physically separate look-alike and sound-alike products
– Build in redundancy, double checks, and fail-safe features
– Test usability
• Institute for Safe Medication Practices (ISMP) maintains that the
failure of device manufacturers to consider principles of human-
factors engineering can contribute to user error
– See textbook pages 75–7 for detailed description of need for focus on
human factors in device design

Gosbee L, et al. In Manasse H, et al., eds. Medication Safety: A Guide for Health Care
Facilities. Bethesda, MD: American Society of Health-System Pharmacists; 2005.
 Human Factors in Device Design:
Medtronic SynchroMed Infusion Pumps
• Reports to the Food and Drug Administration (FDA) describe
accidental intrathecal injections of concentrated morphine during
attempts to refill Medtronic SynchroMed infusion pump, resulting in
fatal overdosages
• The pump is titanium and described as the size of a hockey puck
• The pump is surgically implanted under the skin of the abdomen or
flank and has a catheter that resides in the intrathecal space
• The small injection port on the front allows the drug supply to be
replenished via passage of a thin needle through the skin into the
port and thus into the drug reservoir
• A template to help locate this reservoir is included in the kit
• The problem arises because there is also a catheter access kit for
the device and its template is similar looking
• Identical-looking kits are the problem
Human Factors in Device Design:
SynchroMed Implantable Infusion Pump

Implantable infusion pump Refill kit template (above left) and catheter
access kit template (above right)
Human Factors Recommendations
• Use patient-controlled analgesia (PCA) pumps that read bar
codes to automatically set the concentration
– Strive to use a single concentration of analgesics
– Avoid stocking and using multiple concentrations of the same
drug that differ by a factor of 10 (e.g., 0.5 mg/mL and 5 mg/mL of
morphine)
• Carefully position syringe labels so important drug information
can be seen readily during pump setup and infusion
• Monitor patients frequently and have antidotes readily available
• Consider using oximetry and capnography for PCA patients
and those on continuous narcotic infusions
Human Factors Recommendations
• When new devices are purchased, use failure mode and effects
analysis (FMEA) to proactively identify design flaws and all points
at which user error might occur
• Establish a system of independent double checks when high-
alert medications are administered
• Avoid using pumps with a priming function that can deliver a
bolus during infusions
• If patients or family members will be using medication delivery
devices, provide them with clear spoken and written instructions;
alert them to potential user error with the devices; require return
demonstrations with sufficient practice to ensure competency
• Report drug-related device failure and user error to the USP-
ISMP Medication Errors Reporting Program and to FDA so timely
action can be taken to alert others to problems
 Actions and Outcomes
• Obstacles can derail the RCA team’s work
– Lack of information about exactly why things happened
– Too broad or too narrow a focus
– Frequently recurring events
• Events happen again before corrective action implemented
• Ways to work through obstacles
– Collecting additional information through interviews with a broad
range of staff, patients, and families
– Simulating the event
– Focusing on the situation at hand
– Focusing on what can be done to prevent a similar situation rather
than becoming “hypnotized” by the event
– Researching what has been done in similar situations by using
research tools such as the Web and professional colleagues
 Utility of RCA in the
Medication-Use Process
• Example Case: patient received a large dose of phenytoin
suspension, resulting in mild toxicity
– Immediate reaction, blame the nurse
– The RCA team, instead, found that system-level issues existed
– The resident who ordered the drug was confused about how to
express the dose in the order entry software
– The pharmacist finishing the electronic order was distracted
– The medication was supplied to the nurse in bulk bottles instead
of unit-dose packaging
• Fixing these system-level issues yields larger benefits
because more than one patient and more than one nurse
could be affected
 Utility of RCA in the
Medication-Use Process
• Example Case: an RCA team looked at an event related to
the use of floor-stock IV solutions
– Blaming the nurse for selecting the wrong IV solution would
have been easy
– The RCA team, instead, looked into how the products were
replenished and the process for oversight of the items in
automated dispensing machines
– Systems-level improvements were implemented:
• Dispensing IV solutions with additives through the pharmacy
– Patients benefited from this action and nurses were freed from
some materials management activity
 Tracing System-Level Vulnerabilities:
Case Report by the ISMP
• Partial patient identifier
– A handwritten order for carbamazepine 400 mg twice daily for an adult
patient was received by the pharmacist
– The patient profile was retrieved by typing the last name only
– The pharmacist inadvertently entered the medication into the profile of a
4-year-old child with the same last name
• Computer system weaknesses
– The pharmacist did not recognize that the dosage would be an overdose
for a small child
– The patient’s age was not in a prominent location on the order entry
screen
– The pharmacist could not match the prescribed medication to the patient’s
medical condition because the patient’s diagnoses and comorbid
conditions were not listed on the pharmacy profile
– Computer system did not require entry of a weight for pediatric patients
– No functional dose alerts in the system
 Tracing System-Level Vulnerabilities:
Case Report by the ISMP (continued)
• Nonstandard medication administration record (MAR) checks
– The MAR was delivered to the patient care unit that night, but the nurse did
not notice the error
– MAR verification was not standardized in the hospital; different nurses doing
it different ways, if done at all
– No official policy requiring MAR verification, no written procedures, and
process not addressed during nursing orientation
• Adult dose and dosage form for a child
– The next morning, the nurse crushed the pills and gave the 4-year-old patient
the erroneous dose, failing to recognize it as too high for a child
– Nurse did not question why tablets were sent for a 4-year-old child
– Nurse did not inquire about a more suitable dosage form; the drug is
available in chewable tablets and as a liquid suspension
• Unverified patient history
– Nurse who administered the first dose assumed the child was receiving
carbamazepine because he had a history of seizures
 Tracing System-Level Vulnerabilities:
Case Report by the ISMP (continued)
• Unverified patient history (continued)
– The child did not have history of seizures, but the nurse verbally passed that
erroneous information to the nurses on the next shift, and so on the
information was passed
– The child received three more doses in error, from three different nurses
• Language barrier
– The child’s parents were present when one dose was given
– The nurse tried to tell the parents the medication was used to control
seizures
– The parents and the child had a limited understanding of English and could
not intervene to correct the erroneous seizure history
• Poor physician access to MAR
– The physician did not detect the error during routine rounds
– The nursing MAR was not readily accessible for review
– No electronic or pharmacy computer-generated summary of prescribed
therapy on the chart
 Tracing System-Level Vulnerabilities
Case Report by the ISMP (continued)
• Poor physician access to MAR (continued)
– The physician did not notice that the child was not receiving the
medication he prescribed
– The error was detected when the child became lethargic, developed
nausea and vomiting
– At this point the nurse suspected a problem with the dose and contacted
the physician
– The physician stated he had not prescribed carbamazepine for the patient
– The child’s carbamazepine level was 18 mcg/mL (normal therapeutic
range is 4–12 mcg/mL)
– This error delayed the child’s discharge, although he recovered without
further problems
• Errors are almost never caused by the failure of a single element in
the system
• Underlying system failures lead to errors that often can be identified
through RCA
 No maximum
Ambiguous dose warnings Verbal
drug order Poor physician reporting Language
access to MAR barrier

Communication Drug Environmental Staff

information factors education Patient
education

Latent Failure Model of Complex System Failure

Modified from James Reason, 1991.
 ISMP Case Report Discussion
• Use two patient identifiers (e.g., full name, identification
number, date of birth) to verify patient identity when entering
orders
• Ask the pharmacy system vendor to build “look-alike patient
name” alerts into the order entry system for activation when
more than one patient has the same last name
• Use a computerized prescriber order entry (CPOE) system that
is interfaced with the pharmacy computer system to eliminate
the need for pharmacy order entry
• Post a daily electronic or computer-generated summary of
prescribed medications on each patient’s chart
 ISMP Case Report Discussion
• Standardize, document, and require the use of an MAR
verification process whenever new MARs are distributed (or
rewritten)
• Teach nurses to compare the pharmacy label (on dispensed
medications) with the initial MAR entry before the first dose is
administered to ensure that the pharmacist’s and nurse’s
interpretation and transcription of a medication order is correct
• Require documentation of medical history (including comorbid
conditions) on order entry screens, MARs, and other records
used during change-of-shift reports
• Require recalculation of all doses of pediatric medications
before the drug is dispensed (pharmacists) and during initial
order transcription/verification onto the MAR (nurses) to ensure
the dose is appropriate
 ISMP Case Report Discussion
• Require the entry of weight in computer systems before orders
for pediatric patients can be processed
• Build and test maximum and subtherapeutic dose alerts in the
order entry system (based on patient age and weight when
applicable)
• Encourage nurses to investigate the possibility of an error if
drugs for pediatric patients are dispensed in adult dosage forms
• Provide translators or written information for teaching patients
and families about diagnoses, treatment plans, and newly
prescribed medications
• Establish a process for thoroughly investigating all “missing”
medications before asking nurses to resend an order or before
dispensing the medication again
Health Care Failure Mode
and Effects Analysis
 Introduction to Failure Mode
and Effects Analysis
• Failure mode analysis (FMA)
– Used to find potential risks in a system or product by identifying all the
ways it could possibly fail
– Analyzes why failures occur
– May refer to specific types of failure or to degrees of failure
– Outgrowth of quality control concerns
• Failure mode and effects analysis (FMEA)
– A risk assessment method
– Based on simultaneously analyzing failure modes, their consequences,
and associated risk factors
– Useful in the design stage as well as in the post hoc analysis
– Used most extensively in high-risk areas or by high-cost industries
• FMA and FMEA have been used to reduce the frequency and
consequences of failures
 Failure Analysis
• Historically
– Failures were retraced in a sequential, linear narrative until the
fault was found
• Today
– Many subsystems at play, thus a linear perspective is not always
effective in finding the failure
– More complex systems require systemic analyses of both
production and product failures
– Both FMA and FMEA use systemic analyses
• Systemic analysis does not require that events follow a
single story, but simultaneous examination of all stories
• FMA asks, “What has failed, what could fail, and how?”
• FMEA asks, “Given the various possibilities for failure,
what are the potential consequences of each?”
 Human Error and FMEA
• An estimated 70% to 90% of all accidents are a result of
human error
• Human failures are often equated with blame, which is more
suited to the linear narrative
• The assumption
– Human error is unpredictable, therefore the systemic analysis
approach is often not utilized to find the source of the problem
• The reality
– Human errors are drawn from the limited set of meaningful things
that an individual can do in any defined situation
• Theoretically, human errors are capable of a priori discovery
and analysis because the spectrum of errors is limited

Denning PJ. Human error and the search for blame. RIACS Technical Report TR-89.46; 1989.
 Applying FMEA to
Medication Error Prevention
• FMEA asks what will happen if a health care provider:
– Mistakes one medication for another because of the packaging
– Administers the wrong drug or dose
– Gives a drug to the wrong patient
– Administers a drug by the wrong route or at the wrong rate
– Omits a dose
– Gives a drug at the wrong time
– Takes any action that may produce a medication error
• FMEA may reveal in some cases that:
– The patient can tolerate the error
– The error will be intercepted by the checks and balances built into the health
system’s quality improvement processes
– Specific steps must be put in place to address potential errors that are
intolerable
Designing Error Traps Can Prevent
Errors From Becoming Accidents
Knowledge Performance
Error Error

Safety System
(Error Trap)

Accident
Prevention
 Learning About Potential Failure
Modes From Reported Errors
• Essential to develop a database of error modes by creating a
uniform and rational system of reporting errors and including
those that have not resulted in patient injury and near misses
– Locally (within a facility) or through larger databases
• ISMP is collecting this information in the United States, Canada,
and Spain
• A standard approach to reducing failures in mechanical and
electronic systems is the introduction of redundancy in critical
subsystems
• Multisensory channels could be used to prevent errors
– Example: changing the feel of packaging by making the syringe
rough or square
 Application of FMEA
• FMEA utilizes before-the-fact evaluation rather than RCA
performed after an error
• RCA is essential, but analyzing processes and products before
problems occur is equally important to an organization’s
comprehensive medication error reduction strategy
• FMEA proactively identifies ways in which products or processes
can fail, why they might fail, how they can be made safer
• FMEA must employ an interdisciplinary team approach
• The Joint Commission requires a proactive risk assessment tool
and many organizations have chosen FMEA

Joint Commission on Accreditation of Healthcare Organizations. Failure Mode and Effects

Analysis in Health Care: Proactive Risk Reduction; 2002.

Institute for Healthcare Improvement. Failure mode and effects analysis tools. Available at
www.ihi.org
 An Application of FMEA
• Quantitative steps for FMEA approach
– Choose a high-risk process or product vulnerable to error
– Assemble an interdisciplinary team including those who prescribe,
dispense, administer, and monitor
– Describe and document the process
– Determine potential areas where errors may occur by looking at why
errors might happen considering areas such as the patient’s age,
tolerance to certain drugs, physician knowledge about the medication
– Decide if the potential errors are unacceptable by looking at
consequences for the patient and domino effect on the process
– Prioritize and take action to eliminate or reduce unacceptable errors
– Make sure the actions have been successful
• Table 21-1 illustrates the use of FMEA for analyzing PCA
• Table 21-2 illustrates the quantitative measure for the FMEA
 VA Approach to FMEA
• Healthcare FMEA (HFMEA) was developed by the VA National
Center for Patient Safety (NCPS)
• HFMEA combines FMEA and the FDA’s hazard analysis and
critical control point (HACCP) concepts and decision tree with
definitions and tools from the VA’s RCA process
• NCPS found FMEA systems used successfully in industry
needed modification for use in evaluating health care processes
– Table 21-3 in textbook outlines the sources of concepts used in
HFMEA
– Table 21-4 in textbook compares HFMEA and RCA
– Specific terms used in HFMEA are defined on pages 577–8 in the
textbook
 HFMEA Steps
1. Select a topic
2. Assemble the team
3. Graphically describe the process
4. Conduct a hazard analysis
5. Develop actions and outcome measures
 HFMEA Steps: Selecting a Topic
• Topic should not be too broad or too narrow
• Patient safety officer (PSO) or medication safety officer along with
the quality or risk manager should select the topic
• The Joint Commission advises the use of available information
about sentinel events known to occur in health care institutions
that provide similar care and services
• Topic should have value to the institution and be justifiable to
auditors
• PSO should complete a rough flow diagram, using topic selected,
to outline the primary process steps as used in that hospital
• PSO should then select five or six steps that will be the narrow
focus of the HFMEA
• Sample flow diagram of HFMEA is shown in Figure 21-2 of
textbook
 HFMEA Steps: Forming a Team
• The HFMEA team should be multidisciplinary
– Ensures multiple viewpoints are considered
• Including people who do not know the process ensures
critical review of the accepted standards and practices
and identification of potential vulnerabilities that others
might miss
– Reduces disciplinary bias
• Having at least two subject matter experts on the team
improves chances that the analysis has technical merit
• Designate a team leader and a team recorder
• PSO usually serves as an advisor and consultant
 HFMEA Steps: Graphically
Describing the Process
• Develop the process flow diagram and verify it
• Number the process and subprocess steps on
the flow diagram
– A sample of subprocess steps is illustrated in
Figure 21-3 in the textbook
 HFMEA Steps: Conducting a
Hazard Analysis
• Select a part of the process and conduct a hazard analysis,
listing and numbering all potential failure modes for each part
• Teams should employ different methods for identifying potential
failure modes
– NCPS triage cards for RCA
– Brainstorming
– Cause-and-effect diagramming
• Determine severity and probability and resulting hazard score
– Table 21-2 provides the hazard score matrix
– Table 21-5 presents the HFMEA definitions of severity
• Use a decision tree to determine course of action
– Figure 21-4 shows a hazard analysis decision tree
• Complete a separate worksheet for each failure mode
– Table 21-6 provides a sample failure mode worksheet
 HFMEA Steps: Conducting a
Hazard Analysis
• The team completes the scoring for each failure mode before
moving on to failure mode causes
• Assess the failure mode if the hazard score is 8 or higher
• Team does not need to determine causes for low hazard failure
modes
– Low hazard failure modes are prioritized for action if the hazard is
a single-point weakness
• High hazard scores are de-emphasized if the failure mode has
an existing control measure or if it is detectable before the
event would occur
– Example of detectable hazard: a missing patient wristband
HFMEA Steps: Developing Action
and Outcome Measures
• Team develops a description of actions for each failure mode
selected for remediation
– Identifies outcome measures
– Designates a single person responsible for completing each
action
• Outcome measures for these actions could include setting a
date for checking to ensure that the module has been
activated and setting a date for testing the system
• A critical step is ensuring the system functions effectively and
new vulnerabilities have not been introduced elsewhere
• Leadership of the organization needs to be committed to each
recommended action
– If management does not concur, the team should revise the
action
 The VA Experience
• VA used HFMEA with the topic: assessment of hospitals’
contingency processes for failure of the electronic bar code
medication administration (BCMA) system
– All VA facilities are required to have up-to-date and well-tested
contingency plans for medication administration
– NCPS staff prepared supporting documents and guidelines
– All VA facilities submitted HFMEA reports to NCPS in the fall of 2002
– An HFMEA project reviewed the best ideas from around the country
– Software to help facilities nationwide be in constant readiness
during BCMA downtimes was released
– Disasters, such as hurricanes and power failure, tested this but no
facility reported any major problems
• VA has found that staff now using HFMEA on more projects
 Tips for Performing HFMEA
• Think of failure modes as “what could go wrong”
• Think of the failure mode cause as “why” the failure would occur
• Present failure modes as a problem statement that needs to be
corrected
• Ensure that the team diagrams the flow diagram steps that actually
occur, not the ideal process
• Once the team has diagrammed a process, post the flow charts in the
work area because staff not serving on the team may have ideas for
additional steps that have been forgotten or failure modes that no one
has suggested
• After the team develops the process diagram, have team members
visit the work area to observe staff performing the process and verify
that their assumptions are correct
• Follow the numbering and lettering format for the process and
subprocess diagrams
 Tips for Performing HFMEA
• Chronological event flow diagrams used in RCAs are different
from process flow diagrams used in HFMEA
– RCA event diagrams show what actually happened on the day of
the event
– HFMEA process diagrams depict the usual activities
• For a failure mode or failure mode cause to be classified as
“detectable” on the HFMEA decision tree, it must be so visible
and obvious that it will be discovered before it interferes with
completion of the task or activity
• A single individual should be identified for follow-up on the
corrective actions identified on the HFMEA worksheet
• Use the most recent HFMEA worksheet; for the current version
visit to the VA Web site: www.patientsafety.gov
 Tips for Performing HFMEA
• Conduct a hazard analysis on the failure mode before
identifying failure mode causes, so time is not spent
identifying causes when it is not necessary
• Pick projects of manageable size
• Failure modes can be tough to brainstorm
– Teams can use the literature, the facility’s own events, ISMP
medication safety reports, similar failures from other industries,
and the experience of team members
– If teams get stuck, they should take a break or use creativity-
building exercises to improve the flow of information
– Cause-and-effect diagrams can help by constantly raising the
question “Why?”
 References
Denning PJ. Human error and the search for blame. Research
Institute for Advanced Computer Science. Technical Report TR-89.46;
1989.

Gosbee L, Burkhardt M. Application of human factors engineering in

process and equipment design. In: Manasse H, Thompson K, eds.
Medication Safety: A Guide for Health Care Facilities. Bethesda, MD:
American Society of Health-System Pharmacists; 2005.

Institute for Healthcare Improvement. Failure mode and effects

analysis tools. Available at: www.ihi.org

Joint Commission on Accreditation of Healthcare Organizations.

Failure Mode and Effects Analysis in Health Care: Proactive Risk
Reduction. Oakbrook Terrace, IL: Joint Commission Resources; 2002.

Leape, LL, Woods DD, Hatlie MJ, et al. Promoting patient safety by
preventing medical error [editorial]. JAMA. 1998;280:1444–7.