1. Healthcare Failure Mode and Effect AnalysisSM
Edward J. Dunn, MD, MPH
VA National Center for Patient Safety
HFMEA may remain part of this ppt or may be part of another – like alternative teaching formats

2. Location in our VA NCPS Curriculum Toolkit
Content
Patient Safety Introduction
Human Factors Engineering
HFMEA ppt & exercise
Instructor Preparation
Swift and Long Term Trust
“Selling the Curriculum”
Etc…
Alternative Education Formats
Pt Safety Case Conference (M&M)
Pt Safety on Rounds (Modulettes)
HFMEA participation
Etc…

3. Why use prospective analysis?
Aimed at prevention of adverse events
Doesn’t require previous bad experience (patient harm)
Makes system more robust
JCAHO requirement
NCPS developed HFMEA to give facilities a tool that could be used to proactively evaluate our systems before an adverse event or close call occurs. Proactive analysis gives us the opportunity to get upstream of adverse events and close calls. The point is to take an objective look at our systems without guilt and shame being a factor as they sometimes are in retrospective analysis of an adverse event. When done correctly a prospective analysis will identify system vulnerabilities in many parts of the process that when corrected will make our systems more robust and fault tolerant.
The new JCAHO Patient Safety Standards include a requirement for prospective analysis. NEXT SLIDE

4. JCAHO Standard LD.5.2 Effective July 2001
Leaders ensure that an ongoing, proactive program for identifying risks to patient safety and reducing medical/health care errors is defined and implemented.
Identify and prioritize high-risk processes
Annually, select at least one high-risk process
Identify potential “failure modes”
For each “failure mode,” identify the possible effects
For the most critical effects, conduct a root cause analysis
The JCAHO Standard LD.5.2, which can be found in the Hospital Accreditation Program Standards, requires Leaders to ensure that there is an ongoing and proactive program for identifying risks to patient safety
Components of the program include identifying and prioritizing high risk processes, selecting at least one of these high risk processes each year, and performing a prospective analysis on the process. The goal is to identify failure modes and their effects and implement corrective actions.
JCAHO doesn’t come out and use the term Failure Mode Effect Analysis but they do talk in terms of failure modes and their effects.

5. Who uses failure mode effect analysis?
Engineers worldwide in:
Aviation
Nuclear power
Aerospace
Chemical process industries
Automotive industries
Has been around for over 40 years
Goal has been, and remains, to prevent accidents from occurring
FMEA has been in used for over 40 years in a number of industries to evaluate products and processes for making products. In the traditional FMEA multidisciplinary teams, with a clearly identified scope of work. Each identified failure mode is scored using a 10 point scale, for Severity, Occurrence and Detection. These 3 numbers are then multiplied together to create the Risk Priority Number. When all of the RPNs are known the team picks a cutoff and then corrects everything that has scored higher. Once the team is finished and corrections are made the process is repeated. The definitions used in the process are very general in nature. The top or worst score is a 10 and for severity this is anything that could result in death or injury….

6. Healthcare Version - HFMEASM
Combines:
Traditional Failure Mode Effect Analysis
Hazard Analysis and Critical Control Point
VA Root Cause Analysis
Adapted and Tested in Healthcare Settings
163 VA hospitals (with some success)
Still a complex process/time commitment (see NIH)

7. The Healthcare Failure Mode Effect Analysis 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

8. HFMEATM Hazard Scoring Matrix
Probability
Severity
Catastrophic
Major
Moderate
Minor
Frequent 16 12 8 4
Occasional 9 6 3
Uncommon 2
Remote 1

9. HFMEATM Decision Tree Does this hazard involve a sufficient
likelihood of occurrence and severity to
warrant that it be controlled?
(e.g. Hazard Score of 8 or higher)
Is the hazard so obvious and readily
apparent that a control measure is not
warranted?
(Detectability)
STOP NO
YES
PROCEED TO HFMEA
STEP 5
Does an Effective Control Measure exist for the
identified hazard?
Is this a single point weakness in the
process?
(e.g. failure will result in system failure)
(Criticality)
HFMEATM Decision Tree

10. ICU Alarm Example

11. ICU Alarm Example

12. ICU Alarm Example

13. Failure Mode: 3B1a - Crucial Alarm Ignored and Patient Decompensated
“Blow-up” of One Line
Failure Mode: 3B1a - Crucial Alarm Ignored and Patient Decompensated
Failure Mode
Cause
Action
Outcome Measure
Severity
Frequency
Ignored alarm (desensitized)
Catastrophic
Frequent
Reduce unwanted alarms by: changing alarm parameter to fit patient physiological condition and replace electrodes with better quality that do not become detached
Unwanted alarms on floor are reduced by 75% within 30 days of implementation

14. HFMEA & RCA Differences Similarities Preventive v. reactive
Analysis of Process v. chronological case
Choose topic v. case
Prospective (what if) analysis
Detectability & Criticality in evaluation
Emphasis on testing intervention
Interdisciplinary team
Develop flow diagram
Systems focus
Actions & Outcome measures
Scoring matrix (severity/probability)
Triage questions, cause & effect diag., brainstorming