Institute for Safe Medication Practices
Example of a Health Care Failure Mode and Effects Analysis for IV Patient Controlled Analgesia (PCA)
Processes &
Subprocesses
Failure Modes
(what might happen)
Causes
(why it happens)
Effects Severity Probability
Hazard
Score
Actions to Reduce
Failure Mode
Prescribing
Assess patient Inaccurate pain
assessment
Cultural influences; patient
unable to articulate
Poor pain control
2
4
8
Standard scale to help assess
pain; training on cultural
influences
Choose
analgesic/mode
of delivery
Wrong analgesic
selected
Clinical situation not
considered (age, renal
function, allergies, etc.);
tolerance to opiates not
considered; standard PCA
protocols not followed (or not
available); concomitant use of
other analgesics not
considered; drug shortage;
knowledge deficit; improper
selection of patients
appropriate for PCA
Improper dosing;
improper drug; allergic
response;
improper use of
substitute drug
4
3
12
CPOE with decision support,
clinical pharmacy program;
standard PCA protocol with
education on use; point-of-use
access to drug information;
feedback mechanism on drug
shortages with information on
substitute drugs available;
selection criteria for PCA
patients
Prescribe
analgesic
Wrong dose
(loading, PCA,
constant, lock-out),
route, frequency
Proper patient
monitoring not
ordered
Prescribed on wrong
patient
No order received
Knowledge deficit; mental
slip; wrong selection from
list; information about drug
not available
Knowledge deficit; mental
slip
Similar patient names; patient
identifier not clear; name
does not appear on screen
when ordering medications
Unable to reach covering
physician
Overdose; under-dose;
ADR
Failure to detect
problems early to
prevent harm
Wrong patient receives
inappropriate drug and
dose; ADR; allergic
response
Poor pain control
4
4
3
2
3
3
3
2
12
12
9
4
CPOE with decision support;
clinical pharmacy program;
standard PCA protocols
Standard PCA order sets with
monitoring guidelines
Match therapy to patient
condition; alerts for look-alike
patient names; visible
demographic information on
order form or screen
Proper physician coverage and
communication channels
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