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

-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

Why use prospective analysis?

Aimed at prevention of adverse events
Doesnt 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

Occasional

12

Uncommon

Remote

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)

NO

YES

HFMEATM Decision
Tree

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

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

3B1e

Didn't hear alarm;

remote location
(doors closed to
isolation room)
Caregiver busy;
alarm does not
broadcast to
backup

16

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

Nurse Manager

Management
Concurrence

Haz Score

Action Type
(Control, Accept,
Eliminate)
C

Unw anted alarms on

floor are reduced by
75% w ithin 30 days of
implementation.

Yes

Yes
Biomedical
Engineer

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.

12

12

Outcome
Measure

Yes
Biomedical
Engineer

Proceed?

Probability

Catastrophi
Severity
c

Frequent
Frequent
Occasional

Actions or Rationale for

Stopping

Biomedical
Engineer

3B1d

Didn't hear; alarm

volume too low

12

Occasional

3B1c

Didn't hear; care

giver left immediate
area

16

Frequent

3B1b

Ignored alarm
(desensitized)

16

Occasional

3B1a

Catastrophic

3B1 Don't
respond to
alarm

Catastrophic Catastrophic Catastrophic Catastrophic

Potential
Causes

Evaluate failure
mode before
determining
potential
causes

Decision Tree Analysis

Single Point
Weakness?
Existing
Control
Measure ?
Detectability

Failure
Mode: First

Scoring

Person
Responsible

HFMEA Step 5 - Identify Actions and Outcomes

HFMEA Step 4 - Hazard Analysis

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