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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
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
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
YES
Does an Effective Control Measure exist for the
identified hazard? STOP
NO
NO
PROCEED TO HFMEA
STEP 5
ICU Alarm Example
1
ICU Alarm Example
3A 3B
(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
Occasional
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