Healthcare Failure Mode and

Effect AnalysisSM
Edward J. Dunn, MD, MPH
VA National Center for Patient Safety
edward.dunn@med.va.gov
www.patientsafety.gov
 Location in our VA
NCPS Curriculum
Toolkit
Content Instructor Preparation

- Patient Safety Introduction -Swift and Long Term Trust

- “Selling the Curriculum”
- Human Factors Engineering
- Etc…
-HFMEA ppt & exercise

Alternative Education Formats

- Pt Safety Case Conference (M&M)
- Pt Safety on Rounds (Modulettes)
- HFMEA participation
- Etc…
 Why use prospective analysis?

 Aimed at prevention of adverse

events
 Doesn’t require previous bad
experience (patient harm)
 Makes system more robust
 JCAHO requirement
 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
 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
 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)
 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
 HFMEATM Hazard Scoring Matrix
Severity
Probability
Catastrophic Major Moderate Minor

Frequent 16 12 8 4
Occasional 12 9 6 3

Uncommon 8 6 4 2

Remote 4 3 2 1
 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)
HFMEATM Decision
Tree
NO

Is this a single point weakness in the NO

YES process?
(e.g. failure will result in system failure)
(Criticality)

YES

YES
Does an Effective Control Measure exist for the
identified hazard? STOP

NO

Is the hazard so obvious and readily YES

apparent that a control measure is not
warranted?
(Detectability)

NO

PROCEED TO HFMEA
STEP 5
ICU Alarm Example

1
 ICU Alarm Example

3A 3B

Periodically check Respond to

monitor status alarms

Failure Modes Failure Modes

3A1 Did not check status 3B1 Did not respond
3A2 Misread or misinterpret 3B2 Respond slowly or late
3A3 Partially check
 ICU Alarm Example
HFMEA Subprocess Step: 3B1 - Respond to Alarms
HFMEA Step 4 - Hazard Analysis HFMEA Step 5 - Identify Actions and Outcomes
Failure Scoring Decision Tree Analysis

(Control, Accept,
Mode: First

Action Type

Eliminate)

Management
Concurrence
Potential

Responsible
Evaluate failure

Single Point
Actions or Rationale for Outcome

Detectability
Weakness?
Probability

Haz Score

Measure ?
mode before Stopping Measure

Proceed?
Causes

Existing
Severity
determining

Person
Control
potential
causes
3B1 Don't Catastrophi

Frequent
respond to
alarm 16 N N Y
c

3B1a Ignored alarm Reduce unw anted alarms by: Unw anted alarms on Yes

Nurse Manager
(desensitized) changing alarm parameter to fit floor are reduced by
Catastrophic

Frequent

patient physiological condition 75% w ithin 30 days of

16 N N Y C
and replace electrodes w ith implementation.
better quality that do not become
detached
3B1b Didn't hear; care Alarms w ill be broadcast to Alarms w ill be Yes
Catastrophic

Occasional

giver left immediate Central Station w ith broadcast to the

Biomedical
Engineer
area 12 N N Y C retransmission to pagers central station w ithin 4
provided to care staff. months; complete by
mm/dd/yyyy
3B1c Didn't hear; alarm Set alarm volume on isolation Immediate; w ithin 2 Yes
rophic Catastrophic Catastrophic

Occasional

volume too low room equipment such that the w orking days;

Biomedical
Engineer
12 N N Y E low est volume threshold that can complete by
be adjusted by staff is alw ays mm/dd/yyyy
audible outside the room.
3B1d Didn't hear alarm; See 3B1b See 3B1b
Frequent

remote location
(doors closed to 16 N N Y C
isolation room)

3B1e Caregiver busy; Enable equipment feature that Immediate; w ithin 2 Yes
ional

ical
alarm does not w ill alarm in adjacent room(s) to w orking days;

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

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