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Example of a Health Care Failure Mode and Effects Analysis for Anticoagulants
Processes &
Subprocesses
Failure
Modes
Proximate Causes
Effects
LD
RPN
Severity
Probability
Likelihood of
Detection
Risk
Priority
Number
a) Diagnosis
incorrect
b) Anticoagulant
contraindicated
Diagnosis inconclusive
Didnt know about
current/prior treatment
Scale 1-10:
Patient receives
anticoagulant
when not
indicated
B, ADR
10
Patient receives
anticoagulant
when contraindicated
B, ADR, D
10
Processes &
Subprocesses
Failure
Modes
Proximate Causes
Severity
interactions, other
contraindications and
incompatibilities
Unreliable patient history
c) Unnecessary use
of anticoagulants,
particularly heparin
(including heparin
flush/heparinized
solutions)
Knowledge deficit
Outdated policies/
procedures
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
Unnecessary
risk of error
B, ADR
2) Choose the
anticoagulant
Scale 1-10:
a) Wrong
anticoagulant
selected for
specific patient
Allergic
response
Patient receives
the wrong
anticoagulant
B, T, ADR, D
10
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
Severity
Mental slip
Standard protocols/
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
a) Failure to
initiate standard
order set/preprinted
orders
Dont exist
Dont know they exist
Not followed/dont agree
with protocols
Therapy may
not meet
standard of care
B, T, ADR, D
10
Therapy may
not meet
standard of care
Wrong
drug/dose/
frequency
B, T, ADR, D
B, T, ADR, D
10
10
B, T, ADR, D
10
Outdated/inaccurate
Numerous individual
modifications
b) Sections of preprinted orders
incomplete
c) Wrong
drug/form of
drug/route of
administration
d) Wrong dose
(e.g., daily dose,
loading dose,
maintenance
infusion, titration)
Scale 1-10:
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
Severity
Mental slip
Variable dosing among lowmolecular weight heparin
products
Non-formulary drug
Wrong selection from list
Calculation error
Inadequate medication
reconciliation process
e) Wrong
frequency
Knowledge deficit
Information about drug not
readily available
Inadequate medication
reconciliation process
f) Unsafe
concomitant
therapy with other
anticoagulants
Failure to adjust
the dose when
receiving
concomitant
therapy
Scale 1-10:
Overdose
B
Subtherapeutic
dose
T
Overdose
B, D
10
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
g) Prescribed on
wrong patient
Proximate Causes
h) Orders for
patient monitoring
omitted, incomplete, or inaccurate
(e.g., wrong lab
test, frequency too
often or not
frequently enough)
i) Accidental
discontinuation of
Scale 1-10:
Severity
Patient receives
anticoagulant
when not
indicated
B, ADR, D
Patient does not
receive
anticoagulant
when indicated
T, D
10
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
Failure to adjust
the dose
properly
Failure to detect
problems early
to minimize
harm
B, T, ADR, D
10
Omitted therapy
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
anticoagulant
Proximate Causes
orders temporarily
Severity
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
Scale 1-10:
a) Order not
received/ processed
in pharmacy
b) Delay in
receiving/process-
unit
Medication used from floor
stock, so order not sent
Verbal order not documented
Omitted therapy
Necessary dose
changes not
implemented
B, T, ADR, D
10
Use of floor
stock before
10
D=Risk of death
ADR=Risk of other adverse drug reaction
B=Risk of bleeding
T=Risk of thrombosis
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
ing order
Proximate Causes
Inefficient process for
a) Order
misunderstood
Illegible order
Use of abbreviations (e.g., U)
Use of trailing zeroes
Absent or ineffective
computer alerts
Scale 1-10:
Severity
pharmacy
screening:
possible error
Delay of drug
therapy
T, D
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
Delay in
therapy
Subtherapeutic
dose
T, D
Allergic
response
Overdose
B, D
10
Wrong therapy
B, T, ADR, D
10
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
c) Wrong
administration
times selected
Proximate Causes
Administration times not
standardized
Administration times not
coordinated with lab tests
Miscommunication between
nursing and pharmacy about
time of administration/start
of infusion
Severity
Delayed
therapy
(medication not
on unit)
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
10
Floor stock
drug given:
possible error
Omission
d) Order entered
into wrong patient
profile or wrong
patient encounter
6) Evaluate
safety/appropriateness of order
Scale 1-10:
a) Order not
evaluated by a
pharmacist/not
Time constraints
Environmental factors (e.g.,
interruptions)
Unnecessary
patient-specific
doses on unit
B, T
Patient receives
anticoagulant
when not
indicated
B, T, ADR
10
Floor stock
drug administered: possible
10
Day
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
(pharmacy
screening)
Failure
Modes
evaluated in a
timely manner
Proximate Causes
Didnt receive the order
Didnt know there was an
order
b) Indication/
appropriateness not
Scale 1-10:
Severity
error
Likelihood of
Detection
Night
Delayed
therapy
B, T, ADR, D
Unsafe/inappropriate medica-
Probability
RPN
Risk
Priority
Number
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
Severity
verified
tions/doses
reach the
patient
B, T, ADR
c) Contraindications, interactions,
unsafe doses and
routes of
administration not
detected
Knowledge deficit
Use of nonformulary drug
Inadequate or absent
Unsafe/inappropriate medications/doses
reach the
patient
B, T, ADR, D
10
Allergic
reaction
Overdose
B, ADR, D
Subtherapeutic
dose
T, D
10
computer alerts
(interpretation biases)
Scale 1-10:
a) Wrong product
or dose/concentration
Likelihood of
Detection
RPN
Risk
Priority
Number
7) Prepare
medication
Probability
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
b) Wrong form of
drug (e.g., not
using preservative-free IV
heparin for
neonates)
c) Incompatibility
not detected (e.g.,
retaplace and
heparin)
Proximate Causes
Knowledge deficit
Computer alerts not available
Alerts not read
Alerts bypassed
Severity
Scale 1-10:
Risk
Priority
Number
ADR
B, T, ADR
available
preparing medications
Admixing when premixed
solutions are available
Knowledge deficit
RPN
Toxicity (e.g.,
benzyl alcohol
toxicity)
(interpretation biases)
Likelihood of
Detection
d) Wrong
preparation,
packaging (e.g.,
wrong bar code
applied or correct
bar code not
applied, if
applicable)
Probability
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
8) Check
medication before
distribution
Failure
Modes
e) Variable
bioavailability of
warfarin
a) Check not
completed
Proximate Causes
Use of different
Severity
B, T
Potential error
not detected
B, T, ADR, D
10
Probability
Likelihood of
Detection
Pharmacist-prepared
Technician-prepared
value
Human factors
Environmental factors (e.g.,
distractions, space, lighting,
noise)
Inefficient workflow
Check does not include
comparison to original order
9) Deliver
medication to
patient care unit
Scale 1-10:
a) Delay in
distribution of
medications
Risk
Priority
Number
manufacturers of warfarin
Inefficient workflow
Check perceived to be of low
b) Check failed to
detect an error
RPN
Potential error
not detected
B, T, ADR, D
Delayed
therapy
Omitted therapy
Use of floor
stock: possible
error
B, T, ADR
Delayed
therapy
Omitted therapy
Use of floor
stock: possible
error
B, T, ADR, D
10
Urgent/stat medication
10
D=Risk of death
ADR=Risk of other adverse drug reaction
B=Risk of bleeding
T=Risk of thrombosis
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
b) Delivered to
wrong unit, or
lost in system
Inadequate, untimely
c) Placed wrong
drug/concentration in usual
anticoagulant
storage area/unit
Look-alike packaging
Look-alike drug names
Label ambiguity
Human factors
No verification of stocking
Placed
anticoagulant in
wrong storage
area/unit
communication or interface
with admission/transfer
information
Human factors
Drug mislabeled as to
location of patient
process
Severity
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
Delayed
therapy
Omitted therapy
T
Use of floor
stock: possible
error
B, T, ADR, D
Unneeded drugs
on wrong unit
(possible
administration
to the wrong
patient)
B
Wrong
drug/dose
B, T, ADR, D
Delay in
therapy
T, D
Omitted therapy
T, D
10
Delay in
therapy
Subtherapeutic
dose
10
a) Order not
processed
b) Written/
electronic (typed)
order misunderstood
Scale 1-10:
Illegible order
Use of abbreviations (e.g., U)
Use of trailing zeroes
Misread decimal doses
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
d) Order not
reconciled
e) Order
transcribed onto
MAR incorrectly
f) Order not
transcribed onto
MAR
Severity
T, D
Allergic
response
Overdose
B, D
Wrong drug
therapy
B, T, D
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
10
Wrong drug
therapy
B, T, D
10
Delay in
therapy
Subtherapeutic
dose
T, D
Overdose
B, D
10
Delay/interrupttion in therapy
T, D
10
recopying MARs
Scale 1-10:
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
g) Order
transcribed onto
wrong patients
MAR
12) Evaluate
appropriateness of
the anticoagulant
Scale 1-10:
a) Signal not
received (nurse
does not know to
administer the
medication at a
particular time)
a) Current lab
values not checked
Proximate Causes
Unclear presentation of
patient demographics on
MAR (e.g., light imprint)
Look-alike patient names
Environmental factors (e.g.,
interruption during
transcription, noise, poor
lighting, cluttered space)
Order transcribed before
patient identifier added to
form
Too many MAR pages
Nonstandard time for
administration
Transcription error
Missing MAR
Thought someone else was
administering the drug
Did not hear verbal order
Failure to communicate that
dose is due during change in
shift or level of care
Lab values not available
Low perceived value
Time constraints
Wrong lab values checked
(e.g., wrong patient, wrong
day/time)
Severity
Patient receives
anticoagulant
when not
indicated
B
10
Dose
omitted/delay in
therapy
T, D
10
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
Dose not
adjusted
appropriately
B, T, ADR
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
13) Obtain
medication
Scale 1-10:
Failure
Modes
Proximate Causes
b) Diagnosis does
not support
administration of
anticoagulant
a) Cannot find
medication/not
available on unit
Severity
Patient receives
anticoagulant
when not
indicated
B, ADR
Delay in
therapy
T, D
10
Use of floor
stock/borrowed
medication
without
pharmacy
review
B, ADR, D
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
delivery)
See 10.f1 (require documentation of all drug
administration on a standard MAR)
13.a1 Include brand and generic names on product
labels when appropriate
13.a2 Notify nursing staff upon delivery of
medications to the unit
13.a3 Establish safe, adequate daily par levels for
appropriate floor stock of heparin and warfarin
13.a4 Notify pharmacy, update current dosing
schedule, resend order if requested for missing
medication
13.a5 Pharmacist and nurse should both determine
that missing medication is still an active order with
no pending safety concerns
D=Risk of death
ADR=Risk of other adverse drug reaction
B=Risk of bleeding
T=Risk of thrombosis
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Scale 1-10:
Failure
Modes
Proximate Causes
a) Wrong drug,
Severity
Overdose
B, D
Allergic
reaction
ADR
Subtherapeutic
dose
Omitted drug
Wrong drug
T
10
Overdose
10
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
Day
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
(if necessary)
15) Obtain
infusion pump (if
necessary)
Failure
Modes
dose, diluent,
concentration
Breach in sterility
a) No pump
available
Proximate Causes
Failure to use premixed
solutions
Unfamiliarity with IV
admixture process
Pharmacy service not
provided 24 hours/day,
7 days/week
Absent or failed double
check
Insufficient environment/
equipment to maintain sterile
work environment for
compounding
Re-entry into a multiple-dose
vial with a contaminated
needle
Scale 1-10:
a) Misprogram the
pump: wrong flow
rate (dose),
concentration,
loading dose
Severity
B, D
Subtherapeutic
dose, wrong
drug
T, D
Allergic
reaction, ADR
Infection
Delay in
therapy
T, D
Inaccurate
administration
without a pump
B, T, D
Overdose
B, ADR, D
Subtherapeutic
dose
T, D
Probability
Likelihood of
Detection
Night
10
10
RPN
Risk
Priority
Number
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
Severity
drug
units/hour and mL/hour
a) Check not
completed
b) Check
inadequate
18) Administer
anticoagulant
Scale 1-10:
a) Wrong patient
Likelihood of
Detection
RPN
Risk
Priority
Number
Confusion between
after a temporary increase to
deliver a bolus dose
Forgetting to restart the
pump after a heparin infusion
has been placed on hold
temporarily
No double check required
Inadequate staffing patterns
Time constraints
Low perceived value of
check
Check process not integrated
into the way care is delivered
Probability
Potential error
not detected
B, T, ADR, D
10
Potential error
not detected
B, T, ADR, D
10
Patient receives
anticoagulant
when not
indicated
B, ADR
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
indication for use
b) Wrong drug,
dose, or flow rate
Failure to review/consider
c) Wrong route
check at bedside
Knowledge deficit
Scale 1-10:
Severity
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
10
10
Toxicity
Hematoma
B, D
10
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Scale 1-10:
Failure
Modes
Proximate Causes
d) Duplicate dose/
dose administered
too soon
e) Interruption of
Severity
Overdose
B, D
10
Subtherapeutic
10
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
therapy
f) Incompatibilities
not detected (e.g.,
retaplace and
heparin)
g) Infiltration/
hematoma at
injection site
Epidural or spinal
hematoma
19) Document
anticoagulant
a) Drug
administration not
documented/
misdocumented
Proximate Causes
administration of another
drug
Failure to restart the
anticoagulant after placed on
hold temporarily
Infiltration
Knowledge deficit
Adequate references not
available
Use of anticoagulation
infusion as the primary
infusion into which other IV
medications are administered
Site not rotated
Drug administered
incorrectly
Failure to immobilize
limb/body part of the access
site
Failure to properly anchor
the catheter hub and tubing
Rubbing injection site
Concurrent use of heparin
and spinal/epidural
puncture/procedures
dose
T, D
Hematoma
Interruption of
therapy
T
Human factors
Environmental factors (e.g.,
Duplicate
therapy
Overdose
B, D
10
distractions)
Time constraints
Inefficient documentation
process
Multiple MAR pages/screens
Documentation required in
multiple locations
Documentation before actual
administration
Scale 1-10:
Severity
ADR
Subtherapeutic
dose
T, D
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
Drug omission
T
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
Severity
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
b) Lab tests
ordered at the
incorrect times and
intervals
c) Current lab
values not checked
Time constraints
Wrong lab values checked
Scale 1-10:
Failure to detect
and treat
thrombocytopenia
B, T, ADR
Failure to detect
and treat
thrombocytopenia
Infrequent or
inaccurate dose
adjustments
B, T, ADR
Failure to detect
and treat
thrombocytopenia
B, T, ADR
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
Severity
d) Failure to
monitor for signs
of bleeding and/or
thrombosis/
communicate
changes to the
physician/treat
condition
e) Failure to
diagnose/treat
thrombocytopenia
Knowledge deficit
Inadequate lab monitoring
Forget to discontinue all
sources of heparin
Scale 1-10:
B, D, T, D
10
process
Knowledge deficit
Time constraints
Difficult to detect occult
bleeding
Reluctance to call prescriber
with assessment information
(intimidation)
Patient not informed to alert
practitioners to signs and
symptoms
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
Thrombocytopenia
T, D
10
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
a) Failure to adjust
the dose properly
in a timely manner
Failure to treat
patient/treat patient
incorrectly when
therapeutic levels
are dangerously
elevated
Scale 1-10:
communicated
Failure to monitor patient lab
values frequently enough
Critical lab values not
flagged for reporting
Critical lab values/
assessment findings not
communicated in a timely
manner
Unable to reach physician
with critical lab
results/assessment
information
No protocols for dose
adjustments
No protocols for treatment of
dangerously elevated
INR/aPTT
Forgot to restart medication
after holding
Interpreter biases
Patient-specific parameters
not known/considered (e.g.,
renal and hepatic function,
allergies, platelet count)
Making dose changes more
or less frequently than
necessary for the desired
clinical outcomes
Failing to consider the
residual blocking effects of
phytonadione if this drug has
been administered before a
procedure (to reverse the
effects of an anticoagulant)
Severity
Labile
anticoagulant
levels
B, T, D
10
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
Severity
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
a) Patient is not
educated about
his/her illness,
medication, and
error/injury
prevention
Language barrier
Literacy barrier
Time constraints
Caregiver not available for
Possible
readmission
B, T, ADR, D
10
Possible
readmission
T, D
10
Possible
readmission
B, T, ADR, D
10
No written educational
material available to give to
patient (in the correct
language/reading level)
Healthcare provider
knowledge deficit
Accountability for educating
patients is not clear
Scale 1-10:
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Scale 1-10:
Proximate Causes
Severity
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
Possible
readmission
B, T, ADR, D
10
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.
Processes &
Subprocesses
Failure
Modes
Proximate Causes
Severity
Probability
Likelihood of
Detection
RPN
Risk
Priority
Number
the appointment
Scale 1-10:
B=Risk of bleeding
T=Risk of thrombosis
D=Risk of death
ADR=Risk of other adverse drug reaction
Severity: 10=most severe effect Probability: 10=very likely to occur Detection: 10=very unlikely to detect RPN=product of three scores
Institute for Safe Medication Practices 2007
Note: Hypothetical FMEA for a typical hospital. Specific hospital issues and hazard scores will differ at each practice location.