Introduction: Greetings!

The Department of Veterans Affairs National Center for Patient Safety (NCPS) supports and leads the patient safety activities for all the VA medical centers. Since 1999, NCPS has developed tools, training, and software to facilitate patient safety and root cause analysis investigations. This web site functions as a cognitive aid to help teams in conducting a proactive risk assessment using our developed model of the Healthcare Failure Mode and Effect Analysis (HFMEA^SM). We hope your teams will find this web site an effective aid with these activities. We welcome your comments, suggestions, and feedback.

James P. Bagian, M.D., P.E.

Lead Developers:
Joe DeRosier, P.E, C.S.P.	Erik Stalhandske, M.P.P., M.H.S.A.
Additional Contributions:
Jean Alzubaydi	Tina Nudell
Jim Bagian	Janine Purcell
Jeff Lee	Lesley Taylor

Introduction: How To Use This Guide

If you are a PATIENT SAFETY MANAGER Go to Step 1.

If you are on an HFMEA^SM Team Go to Step 3.

Introduction: The Healthcare Failure Mode Effect Analysis^SM Process

Step 1 - Define the Topic *
Step 2 - Assemble the Team *
Step 3 - Graphically Describe the Process
Step 4 - Conduct the Analysis
Step 5 - Identify Actions and Outcome Measures

*Steps to be completed by the Patient Safety Manager

Next Section: Step 1

Throughout this guide there may be unfamiliar terminology. Below is a list of terms and definitions. These definitions are also highlighted in red. You can see the definition by leaving your mouse cursor over the term -- Try it here.

Detectable Hazard:

Something so visible and obvious that it will be discovered before it interferes with completion of the task and activity.

Effective Control Measure:

A barrier that eliminates or substantially reduces the likelihood of a hazardous event occurring (e.g. an anesthesiology machine may prevent cross connection of medical gases through the use of pin indexing and connectors that have different threads).

Failure Mode:

Different ways that a process or sub-process can fail to provide the anticipated result (i.e. think of it as what could go wrong).

Failure Mode Cause:

Different reasons as to why a process or sub-process would fail to provide the anticipated result (i.e. think of it as why it would go wrong).

Hazard Analysis:

The process of collecting and evaluating information on hazards associated with the selected process. The purpose of the hazard analysis is to develop a list of hazards that are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled.

Healthcare Failure Mode & Effect Analysis (HFMEA^SM) :

1. A prospective assessment that identifies and improves steps in a process, thereby reasonably ensuring a safe and clinically desirable outcome.
2. A systematic approach to identify and prevent product and process problems before they occur.

Single Point Weakness:

A step in the process so critical that its failure would result in system failure or in an adverse event (e.g. momentary interruption of the power supply that would result in the loss of CPRS data).

---

Step 1: Define the Scope of the HFMEA^SM along with a clear definition of the process to be studied.

Select the process you want to examine. Define the scope (be specific and include a clear definition of the process or product to be studied).

This HFMEA^SM is focused on ...

Take the time to finish this sentence; it is an important starting point in your HFMEA.

Step 1 Hints:

• Help your team be successful by defining the boundaries of their assignment -- limiting the scope will increase the chance of a successful HFMEA^SM -- the team is more likely to finish on time, identify vulnerabilities, and develop meaningful actions.
• Joint Commission standards for proactive risk assessment require that you choose a high vulnerability area for review. Consider Joint Commission sentinel event alerts, your system's data on risk, as well as information from relevant journals.

Next: Step 2

---

Multidisciplinary Team with Subject Matter Expert(s) plus Advisor

View and save a Printable Template of this form (PDF).

Step 2: Hints

• Include subject-matter experts and those with no knowledge of the process under review.
• Consider appointing two representatives from critical services so that you have coverage at all meetings.
• Some teams at smaller facilities have been successful with fewer team members; when needed, others are called in as consultants.
• Avoid assigning the leader the additional responsibility of being the recorder.

Next Step: Step 3

---

1. Develop and verify the Flow Diagram (this is a process vs. chronological event diagram).
   
2. Consecutively number each process step identified in the process flow diagram.
   
3. If the process is complex, identify the area of the process to focus on (manageable bite).
   
4. Identify all sub-processes under each block of this flow diagram. Consecutively letter these sub-steps.
   
5. Create a flow diagram composed of the sub-processes.

Step 3: Hints

• Fully develop your process and sub-process diagram before proceeding.
• Use recommended numbering convention to keep track of your work.
• You may need to help group narrow scope of area to review.
• Once you think you have an understanding, confirm with the process owners.
• If feasible, take the whole team to actually observe the process under review.
• The team leader can do pre-work of developing an initial draft of the process flow diagram outside of whole group meetings

---

Background information:

Prostate Specific Antigen (PSA) tests are a high volume and potentially high vulnerability process within the Department of Veterans Affairs. The following PSA HFMEA^SM example was developed on PSA testing to provide you with an illustration of what an HFMEA^SM would look like using the tools we have provided. Note that we have continuously refined our scope of work in this example to ensure that all areas of the process are covered in a limited amount of space. In reality the team would investigate all of the process steps, sub-process steps, failure modes and failure mode causes in their scope of work.

We pick up the example for PSA testing at Step 3 of the HFMEA^SM process. The process flow diagram shown depicts completion of Steps 3A, 3B and 3C. The scope of this example is then further limited by focusing on a particular process step for illustrative purposes.

Hints

• You can choose your focus based upon the greatest process vulnerability, and the area where you can have the best chance of a successful improvement.
• It's better to have fewer actions that hit the mark and are implemented than a list of half-addressed or abandoned proposals

Step 3: Part A - Gather information about how the process works - describe it graphically.

Step 3: Part B - Consecutively number each process step.

1		2		3		4		5

Step 3: Part C - If the process is complex, choose area to focus on.

1		2		3*		4		5

Focus (this example)

*In an actual HFMEA^SM, all process steps (1-5) would be addressed by the team.

Step 3: Part D - List Sub-process steps and consecutively number.

1		2		3		4		5
Order Written Entered in CPRS Received in Lab		ID patient Select proper tube/equipment Draw blood Label blood		Review Order Centrifuge Specimen Verify calibration Run QC Run Sample Report Result Enter in CPRS		Report received		Telephone Visit set up Result given

Step 3: Part E - Create a flow diagram composed of the sub-processes

1		2		3		4		5
Order Written Entered in CPRS Received in Lab		ID patient Select proper tube/equipment Draw blood Label blood		Review Order Centrifuge Specimen Verify calibration Run QC Run Sample Report Result Enter in CPRS		Report received		Telephone Visit set up Result given

Sub-Process Flow for Step 3 (Analyze Sample)
3A		3B		3C		3D		3E
		3F		3G
From step 3E (Run Sample)

Next section: Step 4

---

Step 4: Conduct a Hazard Analysis

1. List Failure Modes
2. Determine Severity & Probability
3. Use the Decision Tree
4. List all Failure Mode Causes

Step 4: Hints

• This is the real heart and soul of the analysis.
• Remember - failure modes are different ways the process or sub-process can fail to provide the anticipated result -- they represent what can go wrong.
• We suggest a flip chart and large post-it notes.
• Some will want to jump to fixes or failure mode causes -- groups report more success if they first fully develop failure modes

---

Sub-Process Flow for Step 3 (Analyze Sample)

3A		3B		3C		3D
Failure Mode: wrong test ordered order not received		Failure Mode: equip. broken wrong speed specimen not clotted no power wrong test tube		Failure Mode: instr. not calibrated bad calibration stored		Failure Mode: QC results unacceptable
3E		3F		3G
Failure Mode: mechanical error tech error		Failure Mode: computer crash result entered for wrong pt. computer transcription error result not entered result misread by tech		Failure Mode: CPRS down

For teaching purposes we will focus only on sub-process step 3F.

The team would want to work through ALL of these sub-process steps in an actual proactive risk assessment

 

---

This will lead you to the Hazard Matrix Score.

The Severity and Probability Ratings that follow are the first step in identifying the potential effects of your identified failure modes and failure mode causes . Use the definitions to classify the severity of the failure as minor, moderate, major or catastrophic. Then classify the probable frequency of the failure as remote, uncommon, occasional or frequent. For consistency, remember to use the definitions provided. Once the Severity and Probability are known use the HFMEA^SM Scoring Matrix to determine a numeric value for the mode or cause. When the hazard score is quantified proceed to the HFMEA^SM Decision Tree .

Step 4B: Severity Rating

Event Severity:	Catastrophic Event
FMEA Rating:	(Traditional FMEA Rating of 10 - Failure could cause death or injury)
Patient Outcome:	Death or major permanent loss of function (sensory, motor, physiologic, or intellectual), suicide, rape, hemolytic transfusion reaction, surgery / procedure on the wrong patient or wrong body part, infant abduction or infant discharge to the wrong family
Visitor Outcome:	Death; or hospitalization of 3 or more
Staff Outcome:	A death or hospitalization of 3 or more staff
Equipment or facility:	Damage equal to or more than $250,000
Fire:	Any fire that grows larger than an incipient

Event Severity:	Major Event
FMEA Rating:	(Traditional FMEA Rating of 7 - Failure causes a high degree of customer dissatisfaction)
Patient Outcome:	Permanent lessening of bodily functioning (sensory, motor, physiologic, or intellectual), disfigurement, surgical intervention required, increased length of stay for 3 or more patients, increased level of care for 3 or more patients
Visitor Outcome:	Hospitalization of 1 or 2 visitors
Staff Outcome:	Hospitalization of 1 or 2 staff or 3 or more staff experiencing lost time or restricted duty injuries or illnesses
Equipment or facility:	Damage equal to or more than $100,000
Fire:	Not Applicable - See Moderate and Catastrophic

Event Severity:	Moderate Event
FMEA Rating:	(Traditional FMEA Rating of 4 - Failure can be overcome with modifications to the process, but there is minor performance loss)
Patient Outcome:	Increased length of stay or increased level of care for 1 or 2 patients
Visitor Outcome:	Evaluation and treatment for 1 or 2 visitors (less than hospitalization)
Staff Outcome:	Medical expenses, lost time or restricted duty injuries or illness for 1 or 2 staff
Equipment or facility:	Damage more than $10,000 but less than $100,000
Fire:	Incipient stage or smaller

Event Severity:	Minor Event
FMEA Rating:	(Traditional FMEA Rating of 1 - Failure would not be noticeable to the customer and would not affect delivery of the service or product)
Patient Outcome:	No injury, nor increased length of stay nor increased level of care
Visitor Outcome:	Evaluated and no treatment required or refused treatment
Staff Outcome:	First aid treatment only with no lost time, nor restricted duty injury nor illness
Equipment or facility:	Damage less than $10,000 or loss of any utility without adverse patient outcome (e.g. power, natural gas, electricity, water, communications, transport, heat/air conditioning)
Fire:	Not Applicable - See Moderate and Catastrophic

Step 4B: Probability Rating

Frequent

Likely to occur immediately or within a short period (may happen several times in one year)

Occasional

Probably will occur (may happen several times in 1 to 2 years)

Uncommon

Possible to occur (may happen sometime in 2 to 5 years)

Remote

Unlikely to occur (may happen sometime in 5 to 30 years)

Step 4B: The HFMEA Scoring Matrix

The HFMEA Scoring Matrix

Probability	Severity
	Catastrophic (4)	Major (3)	Moderate (2)	Minor (1)
Frequent (4)	16	12	8	4
Occasional (3)	12	9	6	3
Uncommon (2)	8	6	4	2
Remote (1)	4	3	2	1

 

---

Note: This decision tree is to be used after the HFMEA Hazard scoring matrix.

The HFMEA^SM Decision Tree is the tool that will help you determine whether your failure mode or failure mode cause needs to have corrective actions developed and implemented. Use the hazard score determined in the previous step to start the triaging process. Proceed down the tree answering the questions "yes" or "no". If you end up at the "Stop," no further work is needed on that specific failure mode or failure mode cause. Remember to document why you stopped on the HFMEA^SM Worksheet for thorough documentation of the process.

Full Decision Tree (PDF file) - View a readable and printable version.

 

---

Step 4: Decoding the HFMEA Worksheet

Decode the worksheet by viewing the HFMEA Worksheet Guide (PDF).

Next Section: Step 5

 

---

1. Decide to "Eliminate," "Control," or "Accept" the failure mode cause .
2. Describe an action for each failure mode cause that will eliminate or control it.
3. Identify outcome measures that will be used to analyze and test the redesign process.
4. Identify a single, responsible individual by title to complete the recommended action.
5. Indicate whether top management has concurred with the recommended actions.

Step 5: Sample Worksheet 1 - Computer Crash

This example describes the reasons for a possible failure by a computer crash (Sub-prcoess Step 3F1). View the PDF for an example of how to complete the HFMEA^SM worksheet.

PDF Version

Graphic Version

The worksheet describes the reasons for a Computer Crash failure mode from process 3F1. A computer crash will affect the "Report Result" step, which is a sub-process of "Analyze Sample" that is a primary step in the PSA process.

Step in the PSA Process Sub-process Failure Modes

1	PSA Test Ordered
2	Draw Sample
3	Analyze Sample	[Step 3 Sub-processes] Review Order Centrifuge Specimen Verify Calibration Run QC Run Sample Report Result Enter in CPRS	[Step 3F Failure Modes] Computer Crash Result entered for wrong patient Computer Transcription Error Result not entered Result misread by tech
4	Report to Physician
5	Result Filed (CPRS)

 

Step 5: Sample Worksheet 2 - Tech misreads results

This example describes the reasons for a possible failure by a Technician misreading results (Sub-prcoess Step 3F5). View the PDF for an example of how to complete the HFMEA^SM worksheet. If you cannot view the PDF, view the Graphic Version of the worksheet.

PDF Version

Graphic Version

This example examines the possible causes for a technician to misread results in Sub-process step 3F5. Notice that it is a different failure mode in the same process and sub-process as the previous example.

Step in the PSA Process Sub-process Failure Modes

1	PSA Test Ordered
2	Draw Sample
3	Analyze Sample	[Step 3 Sub-processes] Review Order Centrifuge Specimen Verify Calibration Run QC Run Sample Report Result Enter in CPRS	[Step 3F Failure Modes] Computer Crash Result entered for wrong patient Computer Transcription Error Result not entered Result misread by tech
4	Report to Physician
5	Result Filed (CPRS)

Step 5: Blank HFMEA^SM Worksheets

All of the below versions look the same. You can print them for future use.

HFMEA Worksheet for Excel (best for download and reuse)

HFMEA Worksheet PDF

HFMEA Worksheet as a Graphic

---

Are facilities expected to conduct an HFMEA^SM for an entire healthcare process or can they focus on a sub-part of this process?

• Facilities may focus on a part of the process, especially if it is a major and complex process.
• Our advice would be for the patient safety committee or patient safety manager to give advance thought to the scope of the process that makes the most sense to focus on, and pursue that particular area.

What is the current status of our approach to HFMEA^SM; has Joint Commission concurred with this process?

• We have consulted with Joint Commission leadership on this approach; they have informed us that they view our work as consistent with their requirements. HFMEA^SM has been published in the May 2002 issue of the Joint Commission Journal on Quality Management.

Can the process be applied to worker safety?

• Yes, HFMEA^SM could be used to look at process issues affecting occupational safety and health.

How do you choose an HFMEA^SM topic for evaluation?

• Use available information about sentinel events. Review information sources available within your facility or health care system that identify high risk and high occurring vulnerabilities.

How long does the HFMEA^SM process take?

• Depends upon the scope of the process or sub-process that is examined
• Depends upon the skill of the team advisor
• Depends upon the commitment of the team members to work effectively, and their team skills
• Based upon our experience with similar processes such as RCAs, we have found that as teams become more skilled and facile, the time decreases and the quality of the product increases.

How can individuals outside of the VA access tools used by HFMEA^SM?

• HFMEA^SM materials are available on the NCPS web site

Who is on the HFMEA^SM team?

• Multidisciplinary representation
• One individual serves as a team leader
• Subject matter expert
• One is the team recorder
• Individual naive to the process

Are there any common pitfalls in conducting HFMEA^SM and what are your recommendations for avoiding them?

• Avoid trying to solve world hunger with your team
• Seek buy-in
• Focus in on a manageable part of the process
• Set a timeline
• Select the team carefully
• Choose a leader for the team comfortable in managing a group process

 

---

Step 5: Tips for Developing Effective Actions

Actions are the critical component of pro-active risk assessment -- and present challenges for the teams. Strong and well-crafted actions have a clear link to the vulnerabilities, and are readily understood.

The table below presents some categories and types of actions that might be considered. Stronger actions are viewed as those that are more likely to be successful in accomplishing the desired changes, rendering greater utility for the effort expended. Note: you may need multiple actions to address a single root cause/contributing factor.

Do actions meet the following criteria:

• Address the root cause/contributing factors
• Are specific and concrete
• A cold reader understands and can implement
• Will be tested or simulated prior to full implementation (when feasible)
• Process owners were consulted

Recommended Hierarchy of Actions

Stronger Actions	Intermediate Actions	Weaker Actions
Architectural/physical plant changes New device with usability testing before purchasing Engineering control or interlock (forcing functions) Simplify the process and remove unnecessary steps Standardize on equipment or process or caremaps Tangible involvement and action by leadership in support of patient safety	Increase in staffing/decrease in workload Software enhancements/modifications Eliminate/reduce distractions (sterile medical environment) Checklist/cognitive aid Eliminate look and sound alikes Read back Enhanced documentation/communication Redundancy	Double checks Warnings and labels New procedure, memorandum, or policy Training Additional study/analysis

Step 5: Tips for Developing Effective Outcomes

Outcome measures provide us a confirmation that what we hoped to accomplish did in fact occur. A well-designed measure will document the effectiveness of our change, and serve as a powerful bargaining chip. With this information, those that are responsible for process changes can be shown that they have made a difference. Likewise, managers and leaders that have invested resources in patient safety can be assured that this is a prudent use with demonstrable impact.

Do outcome measures meet the following criteria:

• Measures effectiveness of the action not completion of the action (e.g. measure that falls assessment occurs for x% of new patients admitted, NOT measure the training of staff on falls assessment)
• Quantifiable with defined numerator and denominator (if appropriate)
• Define sampling strategy and the timeframe for the measurement (e.g. random sampling of 15 charts per quarter)
• Set realistic performance threshold (e.g. don't say 100% compliance unless it will be met)

Step 5: Golden Nuggets

• After the team develops the process diagram, have some team members visit the work area.
• Present failure modes as a problem statement that needs to be corrected (e.g. "inadequate printer power supply" vs. "utility failure").
• Think of failure modes as "what could go wrong" that would prevent the process or sub-process step from being successfully completed. Think of failure mode cause as "why" the failure mode would occur.
• Follow the numbering and lettering format for the process and sub-process diagrams.
• Remember to conduct the hazard analysis on the failure mode before identifying failure mode causes. This will prevent you wasting time identifying and assessing causes that don't need to be addressed. Use the arrow on the worksheet as your cognitive aid!
  
• As required on Table 19 for RCA reports, a single individual should be identified as being responsible for follow up on the corrective actions identified on the HFMEA^SM worksheet.

Congratulations! You have reached the end of the HFMEA^SM process. Please continue to the Resources section.

---

Forms and Decision Tools Used In This Aid

Blank HFMEA^SM Worksheet

Guide to using the the HFMEA^SM Worksheet

HFMEA^SM Severity Rating

HFMEA^SM Decision Tree

HFMEA^SM Probability Rating

HFMEA^SM Scoring Matrix

Citations

1. DeRosier, Joseph; Stalhandske, Erik; Bagian, James P.; Nudell, Tina. Using Health Care Failure Mode and Effect Analysis^SM. The Joint Commission on Accreditation of Heathcare Organizations 27: 248-267, 2002.
2. Hazard Analysis and Critical Control Point Principles and Application Guidelines .
3. McDermot RE, Mikulak RJ, Beauregard MR: The Basics of FMEA . Portland, OR: Productivity, Inc, 1996.
4. Joint Commission on Accreditation of Healthcare Organizations: 2002 Comprehensive Accreditation Manual for Hospitals: The Official Handbook (CAMH). Oakbrook Terrace, IL, 2001.
5. Bagian, JP, et al: Developing and deploying a patient safety program in a large health care delivery system; or You can't fix what you don't know about. Jt Comm J Qual Improv 27: 522-532, 2001.