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
- Patient Safety Introduction
- Human Factors Engineering
Instructor Preparation
-Swift and Long Term Trust
- “Selling the Curriculum”
- 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
YES
Is this a single point weakness in the
process?
(e.g. failure will result in system failure)
(Criticality)
NO
YES
Does an Effective Control Measure exist for the
identified hazard?
YES
STOP
NO
Is the hazard so obvious and readily
apparent that a control measure is not
warranted?
(Detectability)
NO
PROCEED TO HFMEA
STEP 5
YES
ICU Alarm Example
Monitoring Patient Alarms in ICU Isolation Room
1
2
3
4
Patient is being
Transferred to ICU
Isolation Room
Connect to necessary
physiological monitor
and equipment
Provide care and
monitor Alarms
Intervene as
appropriate
Sub Process Steps
A. Periodically check
monitor status
B. Respond to alarms
Sub Process Steps
A. Verify validity of
alarm
B. Reconnect
equipment (if
necessary)
C. Medically intervene
(if necessary)
D. Silence alarm
E. Readjust alarm
parameters (if
necessary)
Sub Process Steps
A. Apply transfer
acceptance checklist
B. Determine type of
isolation and post
C. Determine
parameters to be
monitored
D. Gather and calibrate
monitor and
accessories (e.g.
transducers)
Sub Process Steps
A. Don Personal
Protective Equipment
B. Connect to ventilator
if appropriate
C. Connect monitoring
devices to patient
D. Set Alarm parameters
as appropriate
E. Test Alarm Broadcast
ICU Alarm Example
3A
3B
Periodically check
monitor status
Respond to
alarms
Failure Modes
3A1 Did not check status
3A2 Misread or misinterpret
3A3 Partially check
Failure Modes
3B1 Did not respond
3B2 Respond slowly or late
ICU Alarm Example
HFMEA Subprocess Step: 3B1 - Respond to Alarms
HFMEA Step 4 - Hazard Analysis
3B1e
Didn't hear alarm;
remote location
(doors closed to
isolation room)
Caregiver busy;
alarm does not
broadcast to
backup
Y
C
N
Y
E
16
N
N
Y
C
N
Person
Responsible
Management
Concurrence
Action Type
(Control, Accept,
Eliminate)
C
N
N
Unw anted alarms on
floor are reduced by
75% w ithin 30 days of
implementation.
Nurse Manager
Y
12
12
Reduce unw anted alarms by:
changing alarm parameter to fit
patient physiological condition
and replace electrodes w ith
better quality that do not become
detached
Alarms w ill be broadcast to
Central Station w ith
retransmission to pagers
provided to care staff.
Yes
Y
Y
C
Alarms w ill be
broadcast to the
central station w ithin 4
months; complete by
mm/dd/yyyy
Set alarm volume on isolation
Immediate; w ithin 2
room equipment such that the
w orking days;
low est volume threshold that can complete by
be adjusted by staff is alw ays
mm/dd/yyyy
audible outside the room.
See 3B1b
See 3B1b
Enable equipment feature that
w ill alarm in adjacent room(s) to
notify caregiver or partner(s).
Immediate; w ithin 2
w orking days;
complete by
mm/dd/yyyy
Yes
Biomedical
Engineer
N
Outcome
Measure
Yes
Biomedical
Engineer
N
N
Proceed?
Haz Score
Probability
Catastrophi
Severity
c
Frequent
Frequent
Occasional
12
N
N
Actions or Rationale for
Stopping
Biomedical
Engineer
3B1d
Didn't hear; alarm
volume too low
16
N
Occasional
3B1c
Didn't hear; care
giver left immediate
area
16
Frequent
3B1b
Ignored alarm
(desensitized)
Occasional
3B1a
Catastrophic
3B1 Don't
respond to
alarm
Catastrophic Catastrophic Catastrophic Catastrophic
Potential
Causes
Evaluate failure
mode before
determining
potential
causes
HFMEA Step 5 - Identify Actions and Outcomes
Decision Tree Analysis
Single Point
Weakness?
Existing
Control
Measure ?
Detectability
Failure
Mode: First
Scoring
Yes
“Blow-up” of One Line
Failure Mode: 3B1a - Crucial Alarm Ignored
and Patient Decompensated
Failure Mode
Cause
Severity
Frequency
Ignored alarm Catastr Frequent
(desensitized) ophic
Action
Reduce unwanted
alarms by:
changing alarm
parameter to fit
patient
physiological
condition and
replace electrodes
with better quality
that do not become
detached
Outcome Measure
Unwanted alarms
on floor are
reduced by 75%
within 30 days of
implementation
HFMEA & RCA
Similarities
Interdisciplinary team
Develop flow diagram
Systems focus
Actions & Outcome
measures
Scoring matrix
(severity/probability)
Triage questions, cause &
effect diag., brainstorming
Differences
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