Example of A Health Care Failure Mode and Effects Analysis For IV Patient Controlled Analgesia (PCA)
Example of A Health Care Failure Mode and Effects Analysis For IV Patient Controlled Analgesia (PCA)
Example of A Health Care Failure Mode and Effects Analysis For IV Patient Controlled Analgesia (PCA)
Example of a Health Care Failure Mode and Effects Analysis for IV Patient Controlled Analgesia (PCA)
Processes & Failure Modes Causes Effects Severity Probability Hazard Actions to Reduce
Subprocesses (what might happen) (why it happens) Score Failure Mode
Prescribing
Assess patient Inaccurate pain Cultural influences; patient Poor pain control 2 4 8 Standard scale to help assess
assessment unable to articulate pain; training on cultural
influences
Choose Wrong analgesic Clinical situation not Improper dosing; 4 3 12 CPOE with decision support,
analgesic/mode selected considered (age, renal improper drug; allergic clinical pharmacy program;
of delivery function, allergies, etc.); response; standard PCA protocol with
tolerance to opiates not improper use of education on use; point-of-use
considered; standard PCA substitute drug access to drug information;
protocols not followed (or not feedback mechanism on drug
available); concomitant use of shortages with information on
other analgesics not substitute drugs available;
considered; drug shortage; selection criteria for PCA
knowledge deficit; improper patients
selection of patients
appropriate for PCA
Prescribe Wrong dose Knowledge deficit; mental Overdose; under-dose; 4 3 12 CPOE with decision support;
analgesic (loading, PCA, slip; wrong selection from ADR clinical pharmacy program;
constant, lock-out), list; information about drug standard PCA protocols
route, frequency not available
Proper patient Knowledge deficit; mental Failure to detect 4 3 12 Standard PCA order sets with
monitoring not slip problems early to monitoring guidelines
ordered prevent harm
Prescribed on wrong Similar patient names; patient Wrong patient receives 3 3 9 Match therapy to patient
patient identifier not clear; name inappropriate drug and condition; alerts for look-alike
does not appear on screen dose; ADR; allergic patient names; visible
when ordering medications response demographic information on
order form or screen
Processes & Failure Modes Causes Effects Severity Probability Hazard Actions to Reduce
Subprocesses Score Failure Mode
Dispensing
Send order to Order not Unaware of order on unit; Drug therapy omitted; 3 3 9 Flagging system for new
pharmacy received/processed medication used from floor Overdose; under-dose; orders; policy to send all orders
in pharmacy stock, so order not sent; order ADR; allergic response to pharmacy; physician review
entered onto wrong form or if wrong drug used of new orders with unit staff;
screen; verbal orders not shift chart checks; standard
documented verbal order receipt/
documentation process
Delay in Order not flagged; inefficient Delay in dispensing 3 4 12 As above; standard, efficient
receiving/processing process for sending orders to drug; use of floor stock process for pharmacy order
order pharmacy; order not before pharmacy order receipt; timely review and
seen/misplaced after reaching screening; delay of triaging of orders received in
pharmacy drug therapy pharmacy
Enter order into Order Illegible order; use of Overdose, under-dose; 3 4 12 CPOE; preprinted orders; pro-
computer misunderstood abbreviations, trailing zeroes, allergic response; hibit dangerous abbreviations,
naked decimal doses; verbal ADR; delay in therapy; dose expressions, non-urgent
orders; look-alike drug poor pain control verbal orders; fax original order
names; order copy unclear to pharmacy; seek clarification
directly with prescriber
Checklist/testing to ensure
Standard directions Use of substitute drug due to Overdose, under-dose; 3 2 6 revisions in electronic/print
(concentration, shortage; overlook default poor pain control when changing processes/
mixing instructions) directions in computer when drugs; quick access to
in computer wrong changing processes information on substitute drugs
Processes & Failure Modes Causes Effects Severity Probability Hazard Actions to Reduce
Subprocesses Score Failure Mode
Dispensing (cont’d)
Produce label Label inaccurate Inaccurate order entry Overdose, under-dose; 3 3 9 As above under “order entered
wrong route; ADR into computer” section
Label unclear Ambiguous information; poor Same as above; delay 3 3 9 High quality laser printer;
quality of printer in therapy; poor pain improve presentation of label
control information with nursing input
Label not printed Equipment malfunction; Missed therapy; delay 2 1 2 Routine equipment
improper interface with in therapy; poor pain maintenance and performance
pharmacy computer control testing
Label lost Inefficient process for Same as above 2 2 4 Reorganize workflow and
printing/retrieving labels; placement of printers to
remote location of printer improve efficiency
Prepare Wrong drug Look-alike products stored ADR; overdose; under- 4 3 12 Separate look-alike products;
medication near each other; drug dose; allergic reaction; PCA protocols; feedback
shortage; knowledge deficit poor pain control mechanism on drug shortages
with information on substitute
drugs available; readily
available mixing protocols;
compounding log of ingredients
with lot numbers; independent
double check
Processes & Failure Modes Causes Effects Severity Probability Hazard Actions to Reduce
Subprocesses Score Failure Mode
Dispensing (cont’d)
Deliver Delay in distribution Inadequate staffing Delay in drug therapy; 3 4 12 Establish dedicated delivery
medication to patterns/equipment used for use of floor stock system under direct control of
patient care unit delivery of drugs; inefficient before pharmacy order pharmacy; use dedicated
drug delivery system; screening staff/equipment for medication
delivery equipment delivery; routine maintenance
mechanical failure; shared and update of equipment
delivery system
Order transcribed Same as above; too many Same as above 3 3 9 Same as above; pharmacy
onto MAR sections/pages of MAR; lack computer-generated MAR; staff
incorrectly of support staff training; training; environment free of
distractions; failure/absence distractions; user-friendly
of double check; knowledge MAR; consistent double check
deficit process
Order transcribed Look-alike patient names; Same as above 2 3 6 Look-alike name alerts; vivid
onto wrong MAR poor presentation of patient demographics on MAR forms;
demographics on MAR; order high quality imprint machines
transcribed before patient
identifier added
Processes & Failure Modes Causes Effects Severity Probability Hazard Actions to Reduce
Subprocesses Score Failure Mode
Administration (cont’d)
Obtain PCA No pump available Inadequate supply; hoarding; Delay in therapy; poor 3 3 9 Purchase adequate supply of
infusion pump bottlenecks with cleaning pain control; use of pumps; central distribution
process improper pump/no center; efficient cleaning
pump; overdose, process
under-dose
Wrong pump As above; knowledge deficit Delay in therapy; poor 2 2 4 As above; staff training
selected pain control
Obtain PCA Cannot find Pharmacy delivery problem; Delay in therapy; poor 2 2 4 Efficient pharmacy delivery
medication dispensed no communication to nurse pain control process and communication
medication that medication delivered
Wrong drug Look-alike products stored ADR; overdose; under- 4 3 12 Separate look-alike products;
near each other (automated dose; allergic reaction; PCA protocols; feedback
dispensing cabinets, floor poor pain control mechanism on drug shortages
stock, refrigerator); drug with information on substitute
shortage; knowledge deficit drugs available; independent
double check
Wrong Same as above; unnecessary Overdose; under-dose; 4 3 12 Same as above; use one
concentration multiple concentrations poor pain control standard concentration (use
available; knowledge deficit; auxiliary warning labels if
calculation error using different concentration
and have pharmacy dispense
the drug); PCA protocols;
independent double check
Error during Unfamiliarity with IV ADR; overdose; under- 4 4 16 Full pharmacy IV admixture
compounding admixture; no pharmacy dose; allergic reaction; service; purchase prefilled
(wrong drug, wrong service at night; failure of poor pain control syringes/cassettes from
diluent, wrong double check manufacturer
concentration)
Processes & Failure Modes Causes Effects Severity Probability Hazard Actions to Reduce
Subprocesses Score Failure Mode
Administration (cont’d)
Program pump Pump mis- Design flaw in pump (e.g., Overdose; under-dose; 4 3 12 Purchase pumps that are easy to
programmed (flow Abbott LifeCare PCA pump) poor pain control program: use FMEA process to
rate, concentration, which makes programming determine potential failure
lock out, loading error-prone; lack of standard modes of pumps to guide
dose) concentrations; failure to limit purchasing decisions; limit
variety of products used; variety of pumps; train staff on
knowledge deficit; confusion use of new pumps; minimize
between units of measure (mg variety of products used for
vs. mcg); mechanical failure PCA; standardize
concentrations used; PCA
protocols; independent double
check at bedside
Check Check not Inadequate staffing patterns; Potential error not 4 3 12 Adequate staffing patterns;
medication/ completed lack of making the check a detected and likely to engaging staff in culture of
pump settings priority; previous successful reach the patient safety; understand causes for
before violations; check process not prior successful violations and
administration integrated into the way care is take action to eliminate barriers
delivered to consistent checks; build
check processes into the care
delivery model in use
Processes & Failure Modes Causes Effects Severity Probability Hazard Actions to Reduce
Subprocesses Score Failure Mode
Administration (cont’d)
Administer PCA Wrong route Catheter attachment ADR; poor pain 4 2 8 As above under
(cont’d) confusion; failure of double control “medication/pump settings
check at bedside checked” section; label
proximal ends of lines near
insertion ports
Processes & Failure Modes Causes Effects Severity Probability Hazard Actions to Reduce
Subprocesses Score Failure Mode
Monitoring
Monitor effects Insufficient Workload; knowledge deficit; Failure to recognize the 3 3 9 Standard order sets with
of medication monitoring of monitoring parameters not consequences of an monitoring guidelines; standard
effects of PCA ordered; ineffective error before patient scale to help assess pain;
communication between harm occurs; inability training on cultural influences;
caregivers; cultural influences to evaluate pain proper staffing patterns and
management; poor pain safe workload; use flow sheet
control at bedside to document PCA
and patient monitoring
parameters
Scoring Guidelines*
Key for Severity Rating:
Severity Score Description
1 Minor patient outcome: No injury, nor increased length of stray, nor increased level of care
2 Moderate patient outcome: Increased length of stay or increased level of care for 1 to 2 patients
3 Major patient outcome: Permanent lessening of bodily functioning (sensory, motor, physiologic, or intellectual), disfigurement,
surgical intervention required, increased length of stay for 3 or more patients, increase level of care for 3 or more patients
4 Catastrophic patient outcome: death or major permanent loss of function (sensory, motor, physiologic, intellectual), suicide, rape,
hemolytic transfusion reaction, surgery/procedure on the wrong patient or wrong part of body, infant abduction or discharge to
wrong family
Failure modes with scores that fall in the gray area (8 and greater) should be given highest priority
Probability Severity of Effect
Catastrophic Major Moderate Minor
Frequent 16 12 8 4
Occasional 12 9 6 3
Uncommon 8 6 4 2
Remote 4 3 2 1
*Scoring method adapted from: VA National Center for Patient Safety, Healthcare Failure Mode and Effect Analysis (HFMEA™)