Course Objectives
By the end of the course, participants will:
Understand the purpose of Healthcare FMEA
Have a conceptual understanding of the steps
of the Healthcare FMEA process
Know how to choose an appropriate topic for
analysis
Be able to successfully address the JCAHO
2001 proactive risk assessment standard
10
Intent of LD.5.2
The organization seeks to reduce the risk of
sentinel events and medical/health care
system error-related occurrences by
conducting its own proactive risk assessment
activities and by using available information
about sentinel events known to occur in health
care organizations that provide similar care
and services. This effort is undertaken so that
processes, functions and services can be
designed or redesigned to prevent such
occurrences in the organization.
11
12
16
18
Differences
Process vs. chronological
flow diagram
Prospective (what if)
analysis
Choose topic for
evaluation
Include detectability
and criticality in
evaluation
Emphasis on testing
intervention
19
Identified process
issue;
focus for intervention
20
Production
Pressures
Lack of
Zero fault
Procedures
tolerance
Mixed
Punitive Messages Sporadic
policies
Training
Attention
Distractions
Deferred
Maintenance
Clumsy
Technology
Patient
l
a
t
c
ro
c
en
l
o
P
/
a
n
r
m
l
o
/P
io eam idu ron
l
P
s
o
s
P
C
iv nvi
T
e
f
d
M
A
o
In
E
VA
VH
Pr
DEFENSES
Accident
21
Redundancy
Usability Testing
Simplification
Fail-safe designs
Reduce Reliance on
Memory & Vigilance
Simplify
Standardize
Checklists
Forcing Functions
Eliminate Look and Soundalikes
Simulate
Looser coupling of systems
Organizational
Increase Constructive Feedback
and Direct Communication
Teamwork
Drive Out Fear
Leadership Commitment
22
24
25
26
27
28
29
30
31
32
Date Completed_____________
4.______________________
2.__________________
5.______________________
3.__________________
6.______________________
Team Leader
____________________________________
YES / NO
Are different levels and types of knowledge represented on the team? YES / NO
Who will take minutes and maintain records?____________________________
33
HFMEA Worksheet
HFMEA Subprocess step name and title
HFMEA Step 4 - Hazard Analysis
Action
Type
Actions or Rationale
(Control,
for Stopping
Accept,
Eliminate)
Outcome Measure
Management
Concurrence
Proceed?
Detectability
Single Point
Weakness?
Haz Score
Potential Causes
Severity
Probability
Failure Mode:
Existing Control
Measure ?
Person
Responsible
Scoring
34
NO
YES
NO
YES
YES
STOP
NO
YES
NO
PROCEED TO HFMEA
STEP 5
35
YES
NO
36
NO
YES
37
YES
NO
STOP
38
YES
NO
STOP
PROCEED
39
Hazard Analysis
SEVERITY RATING:
Catastrophic Event
(Traditional FMEA Rating of 10 - Failure could
cause death or injury)
Patient Outcome:Death or major permanent
loss of function (sensory, motor, physiologic, or
intellectual), suicide, rape, hemolytic transfusion
reaction, Surgery/procedure on the wrong patient
or wrong body part, infant abduction or infant
discharge to the wrong family
Visitor Outcome: Death; or hospitalization of 3
or more.
Staff Outcome: * A death or hospitalization of 3
or more staff
Equipment or facility: **Damage equal to or
more than $250,000
Fire: Any fire that grows larger than an incipient
Major Event
40
Hazard Analysis
SEVERITY RATING:
Moderate Event
(Traditional FMEA Rating of 4 Failure can
be overcome with modifications to the
process or product, but there is minor
performance loss.)
Minor Event
(Traditional FMEA Rating of 1 Failure would
not be noticeable to the customer and would
not affect delivery of the service or product.)
Hazard Analysis
PROBABILITY RATING:
Frequent - Likely to occur immediately or within a short
period (may happen several times in one year)
Occasional - Probably will occur (may happen several
times in 1 to 2 years)
Uncommon - Possible to occur (may happen sometime
in 2 to 5 years)
Remote - Unlikely to occur (may happen sometime in 5 to
30 years)
42
Catastrophic
Major
Moderate
Minor
Frequent
16
12
Occasional
12
Uncommon
Remote
43
44
45
Date Completed_____________
4.______________________
2.__________________
5.______________________
3.__________________
6.______________________
Team Leader
____________________________________
YES / NO
Are different levels and types of knowledge represented on the team? YES / NO
Who will take minutes and maintain records?____________________________
46
Teaching Example
Step 3A. Gather information about how the process
works describe it graphically.
Wake Up
Get
dressed
Start the
car
Drive the
car
Park the
car
Walk into
work
47
Teaching Example
Step 3B. Consecutively number each process
Wake Up
Get
dressed
Start the
car
Drive the
car
Park the
car
Walk into
work
48
Teaching Example
Step 3C. If process is complex, choose area to focus
on.
Wake Up
Get
dressed
Start the
car
Drive the
car
Park the
car
Walk into
work
49
Teaching Example
Step 3D. If necessary, list sub-process steps and
consecutively number.
Wake Up
Get
dressed
2A. Get
coffee
2B. Take
shower
2C. Find
clean
clothes
2D. Find
shoes
Start the
car
Drive the
car
Park the
car
4A. Coffee in
cupholder
5A. Notice
and take exit
4B. Bagel on
seat
5B.Negotiate
turn
4C. Listen to
traffic report
4D. Choose
route
Walk into
work
6A. Collect
bag, coffee,
bagel
6B. Close
and lock
doors
6C. Begin
walking
6D. Return
for keys 50
Teaching Example
Step 3D. Wake up (Sub-process flow diagram)
1A. Hit
snooze
button
1B. Again,
hit snooze
button
1C. Get
out of
bed
1D. Look
for fuzzy
slippers
51
Teaching Example
Step 4A. List all failure modes.
1A. Hit
snooze
button
1B. Again,
hit snooze
button
1C. Get
out of
bed
1D. Look
for fuzzy
slippers
Failure Modes
1A(1) Turn off
alarm
1A(2) Unplug
Alarm
1A(3) Break
alarm clock
52
1A(1)
P ro ceed ?
D etectab ility
H az S co re
S in g le P o in t
W eakn ess?
Potential Causes
S everity
P ro b ab ility
Failure Mode:
Action
Type
Actions or Rationale
(Control,
Outcome Measure
for Stopping
Accept,
Eliminate)
P e rs o n
R e s p o n s ib le
Managem ent
C o n c u rre n c e
Scoring
Turn off
alarm
53
HFMEA Worksheet
Hit Snooze Button - 1A
HFMEA Step 4 - Hazard Analysis
1A(1)
Action
Type
Actions or Rationale
(Control,
Outcome Measure
for Stopping
Accept,
Eliminate)
P e rs o n
R e s p o n s ib le
Managem ent
C o n c u rre n c e
P ro ceed ?
H az S co re
S in g le P o in t
W eakn ess?
Potential Causes
S everity
P ro b ab ility
Failure Mode:
D etectab ility
Scoring
Turn off
alarm
54
Major Event
PROBABILITY RATING:
Frequent - Likely to occur immediately or within a short period
(may happen several times in one year)
Occasional - Probably will occur (may happen several times
in 1 to 2 years)
Uncommon - Possible to occur (may happen sometime in 2
to 5 years)
Remote - Unlikely to occur (may happen sometime in 5 to 30
years)
56
Catastrophic
Major
Moderate
Minor
Frequent
16
12
Occasional
12
Uncommon
Remote
57
YES
NO
58
NO
YES
59
YES
NO
STOP
60
YES
NO
STOP
PROCEED
61
Detectab ility
------>
Turn off
alarm
O c c as ional
1A(1)
Haz S co re
S everity
Potential Causes
M ajor
P ro b ab ility
Failure Mode:
P ro ceed ?
E xistin g Co n tro l
M easu re ?
Scoring
Action
Type
Actions or Rationale
Outcome Measure
(Control,
for Stopping
Accept,
Eliminate)
P e rs o n
R e s p o n s ib le
Managem ent
C o n c u rre n c e
62
oc c as ional
------>
P ro ceed ?
H az S co re
S in g le P o in t
W eakn ess?
S everity
Action
Type
Actions or Rationale
(Control,
Outcome Measure
for Stopping
Accept,
Eliminate)
Eliminate
oc c as ional
Turn off
alarm
m ajor
1A(1)
Potential Causes
m ajor
P ro b ab ility
Failure Mode:
D etectab ility
Scoring
------>
P e rs o n
R e s p o n s ib le
Managem ent
C o n c u rre n c e
Purchase by certain
date xx/xx/xx
YOU
Yes
63
PSA test
ordered
Process Step
Draw
sample
Process Step
Analyze
sample
Process Step
Report to
physician
Process Step
Result filed
(CPRS)
64
PSA test
ordered
Draw
sample
Analyze
sample
Report to
physician
Result filed
(CPRS)
65
PSA test
ordered
Draw
sample
Analyze
sample
Report to
physician
Result filed
(CPRS)
66
PSA test
ordered
Draw
sample
Analyze
sample
Report to
physician
Result filed
(CPRS)
Sub-processes:
Sub-processes:
Sub-processes:
Sub-processes:
Sub-processes:
A. Order written
B. Entered in
CPRS
C. Received in
lab
A. ID patient
B. Select proper
tube/equip.
C. Draw blood
D. Label blood
A. Review order
B. Centrifuge
Specimen
C. Verify
Calibration
D. Run QC
E. Run sample
F. Report result
G. Enter in CPRS
A. Report
received
A. Telephone
B. Visit set up
C. Result given
67
3A.
Review
order
3B.
Centrifuge
specimen
3C.
Verify
calibration
3D.
Run QC
3E.
Run
sample
3F.
Report
result
3G.
Enter in
CPRS
68
Centrifuge
specimen
Verify
calibration
Run QC
Run
Sample
Enter
result
(CPRS)
Report
result
Failure Mode:
Failure Mode:
Failure Mode:
Failure Mode:
Failure Mode:
Failure Mode:
1.Wrong test
ordered
2.Order not
received
1.Equip. broken
2.Wrong speed
3.Specimen not
clotted
4.No power
5.Wrong test
tube
1.Instr not
calibrated
2.Bad
calibration
stored
1.QC results
unacceptable
1.Mechanical
error
2.Tech error
1.Computer crash
2.Result entered
for wrong pt.
3.Computer
transcription
error
4.Result not
entered
5.Result misread by tech
69
Detectability
Probability
Haz Score
9
Occasional
------>
Software
license expired
Remote
Occasional
Moderate
3F(1)c
------>
------>
Control
N/A
Ongoing/continuous
program to replace
existing equipment
N/A
Outcome Measure
Chief
IRM
Virus
Major
3F(1)a
Occasional
Severity
Major
Computer
Crash
Moderate
3F(1)
Potential Causes
Action
Type
Actions or Rationale
(Control,
for Stopping
Accept,
Eliminate)
Management
Concurrence
Existing Control
Measure ?
------>
Failure Mode:
First Evaluate failure
mode before
determining potential
causes
Proceed?
Single Point
Weakness?
Person
Responsible
Scoring
Software installed
70
YES
NO
71
NO
YES
72
YES
NO
STOP
73
YES
NO
STOP
PROCEED
74
Detectability
Probability
Haz Score
9
Occasional
------>
Software
license expired
Remote
Occasional
Moderate
3F(1)c
------>
------>
Control
N/A
Ongoing/continuous
program to replace
existing equipment
N/A
Outcome Measure
Chief
IRM
Virus
Major
3F(1)a
Occasional
Severity
Major
Computer
Crash
Moderate
3F(1)
Potential Causes
Action
Type
Actions or Rationale
(Control,
for Stopping
Accept,
Eliminate)
Management
Concurrence
Existing Control
Measure ?
------>
Failure Mode:
First Evaluate failure
mode before
determining potential
causes
Proceed?
Single Point
Weakness?
Person
Responsible
Scoring
Software installed
75
Confusing
readout on
PSA
instrument
Probability
frequent
frequent
frequent
remote
frequent
3F(5)d
------>
------>
------>
------>
------>
Staff increased
Chief
PALMS
New equipment on
site
Chief
PALMS
Outcome Measure
N/A
Control
Hire Tech
N/A
Eliminate
New equipment
Poor lighting
Moderate
3F(5)c
Management
Concurrence
Too busy
Moderate
3F(5)b
Tech fatigue
Moderate
3F(5)a
Haz Score
Severity
Moderate
Moderate
3F(5)
Potential Causes
Action
Type
Actions or Rationale
(Control,
for Stopping
Accept,
Eliminate)
Person
Responsible
Detectability
------>
Failure Mode:
First Evaluate failure
mode before
determining potential
causes
Proceed?
Existing Control
Measure ?
Scoring
76
77
Process Step
Process Step
Medication
ordered
(CPRS)
Auto
electronic
transfer to
Pharmacy
package
Pharmacy
fills script;
sends to
floor
Process Step
Nurse
administers
78
Process Step
Process Step
Medication
ordered
(CPRS)
Auto
electronic
transfer to
Pharmacy
package
Pharmacy
fills script;
sends to
floor
Process Step
Nurse
administers
79
Process Step
Process Step
Medication
ordered
(CPRS)
Auto
electronic
transfer to
Pharmacy
package
Pharmacy
fills script;
sends to
floor
Process Step
Nurse
administers
80
Medication
ordered
(CPRS)
Auto
electronic
transfer to
Pharmacy
package
Pharmacy
fills script;
sends to
floor
Nurse
administers
Sub-processes:
Sub-processes:
Sub-processes:
Sub-processes:
A-Dummy
terminal
B-PCs
A-Check drug
A-Automatically
fills orders
checked
B-Drugs pulled
and script filled
C-Med cart filled
D-Cart sent to
floor
A-Log on to laptop
B-Medcart
C-Medications
scanned
D-Patient band
scanned
E-Medication given to
patient
F-Patient record
updated
81
allergies
B-Check drug
interactions
C-Check proper
dosages
D--Orders Labs
E-order sent to
auto dispensing
Auto
electronic
transfer to
Pharmacy
package
Pharmacy
fills script;
sends to
floor
Nurse
administers
Sub-processes:
Sub-processes:
Sub-processes:
Sub-processes:
A-Dummy
terminal
B-PCs
A-Check drug
A-Automatically
fills orders
checked
B-Drugs pulled
and script filled
C-Med cart filled
D-Cart sent to
floor
A-Log on to laptop
B-Medcart
C-Medications
scanned
D-Patient band
scanned
E-Medication given to
patient
F-Patient record
updated
allergies
B-Check drug
interactions
C-Check proper
dosages
D-Orders Labs
E-order sent to
auto dispensing
82
Get med
cart
Scan
meds
Scan
patient
band
Give
med
Update
record
83
Get med
cart
Scan
meds
Failure Modes:
Failure Modes:
Failure Modes:
1.laptop missing
2.network down
3. No battery power
4.CPRS not functioning
5.forget password
6.Pharmacy pkg down
7.RF system not working
8.Server off line/down
84
Give
med
Update
record
Failure Modes:
Failure Modes:
Failure Modes:
1.Wrong ID
2.Band missing
3.Band not
readable
4.Patient not there
1.Patient wont/
cant take med
85
Get med
cart
Scan
meds
Failure Modes:
Failure Modes:
Failure Modes:
1.laptop unavailable
2. No battery power
3. network down
4.CPRS not functioning
5.forget password
6.Pharmacy pkg down
7.RF system not working
8.Server off line/down
4A(2)b Locked in an
office
Occasional
Management
C oncurrence
Probability
Occasional
Control
Buy backup
Total downtime is
less than or equal to
15 minutes
Chief
IRM
Control
Total downtime is
less than or equal to
15 minutes
Chief
IRM
Action
Type
Actions or Rationale
(Control,
Outcome Measure
for Stopping
Accept,
Eliminate)
Theft
Occasional
4A(1)a
Haz Score
Severity
M oderate
Laptop
unavailable
Moderate
4A(1)
Potential Causes
M oderate
Person
R esponsible
Detectability
Failure Mode:
Proceed?
Existing Control
M easure ?
Scoring
87
Detectability
P robability
Oc casional
No power
Haz S core
S everity
Potential Causes
Battery not
charged up
Oc cas ional
Occ asional
M oderate
4A(2)b
Action
Type
Actions or Rationale
Outcome Measure
(Control,
for Stopping
Accept,
Eliminate)
M oderate
4A(2)
M oderate
P roceed?
E xisting Control
M easure ?
Scoring
Failure Mode:
Person
R esponsible
Management
C oncurrence
Control
Backup battery
Total downtime is
less than or equal to
15 minutes
Chief
IRM
Control
Power available
Chief
ENG
88
89