Download Failure Mode Effect Analysis on Anticoagulation Across the Continuum

Failure Mode Effect Analysis
on Anticoagulation Across
the Continuum
May 2, 2009
Anthony Nolosco, MS., R.Ph.
Associate Director, Pharmacy
Woodhull Hospital
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RATIONALE FOR SELECTING
THIS PROJECT
National Patient Safety Goal (NPSG)
03:05:01
• Reduce the likelihood of patient harm
associated with the use of
anticoagulation therapy.
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MULTIDISCIPLINARY
TEAM
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Medicine
Nursing
Pharmacy
Laboratory
Dietary
Information Technology
Quality Management
Patient Safety Committee Chair
Patient Safety Committee Officer
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DO
PLA
N
DO
PLA
N
STUDY
N
Full implementation – (1/09)
Joint Commission
Pilot Testing in 8-100 and Anticoagulation
Clinic- (10/08) Joint Commission
•Adjustment of system for monitoring and follow up
appts. in ambulatory and labs.
ACT
STUDY
PLA
ACT
3 mthStudy of the
Rocess Jan - Apr
•Work plan will be implemented that identifies adequate resources
and a timeline for full implementation – (7/08) Joint Commission
DO
ACT
STUDY
Process/Timeline
•Review Heparin, LMWH and Warfarin Protocol clinical guidelines (Draft Completed)
•Five Implementation Strategies were identified to commence work on the high
RPN’s from the FMEA – (4/08)
•Responsibility for oversight, coordination and implementation of Requirement 03:05:01 was assigned to Dr.
Gregorio Hidalgo – (4/08) Joint Commission
•Additional safety measures implemented
•Anticoagulation Clinic established
•Multidisciplinary Team formed & FMEA Phase I (1/08)
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Strategies for FMEA Process
• Identified issues from the aspect of
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Item and Functions involved for each discipline
Potential Failure Mode
Potential Effect(s) of Failure
Potential Cause(s) of Failure
Current Controls
Rate Potential causes of failure based on Severity,
Occurrence, Detection and assigned a Risk Priority
Number
– Recommended Actions for improvement
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CAUSE AND EFFECT
Patient
Staff
Ignored alerts
Compliance
Barriers to
learning
Communication
Specimen mislabeled
Wrong pt. selected
Wrong med ordered/dispensed/administered
Wrong weight used
Wrong dose, route, rate or diluent
Weight not considered
Pt.’s idiosyncratic
response
Allergy info not checked
Contraindications not observed
Drug interactions not evaluated
Pt. does not report
Signs and symptoms
Indication for anticoagulation not present
Pt. information not
complete
Order not sent
Order not renewed
Labs not checked/wrong lab checked
Labs not ordered Adverse Outcomes
Related to
Anticoagulation
Therapy
Order sets incorrect
Contraindications not checked
Protocol not followed
Duplicate drug therapy
Infusion pump programmed incorrectly
Equipment failure
Drug not available
Drug reference not available
No monitoring occurs
Safety Alerts not functioning
Existing protocol is not easy
To follow
Lab info not available
CPOE system not updated
No redundancy built into the process
Computer system down
No safeguards built into the process
Prescribing errors not identified/corrected
Equipment
Policies & Procedures
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Analysis: High (Risk Priority Number)
Potential
Failure Mode
Potential
Effects of
Failure
Potential
Causes of
Failure
Current
Controls
S
O
D
RPN
Recommended
Actions
Failure to
keep follow-up
appointment
Incomplete
management
and treatment
with
anticoagulation
Therapy
Communication
not received by
provider
Appointment provider
cards provided in clinic.
Staff tracks and followsup on “no shows”.
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8
504
Post Discharge
patient
appointment in
CPOE system
to alert provider.
Inappropriate
Dispensing
Inappropriate
Anticoagulation
Contraindication
not evaluated
and labs not
checked
Lab and pharmacy
computer system
interface
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9
432
Institute an
interactive
criteria engine
that will force
“hard stop”
based on
certain values.
Legend:
S=Severity
O=Occurrence
D=Likelihood of Detection
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Analysis: High (Risk Priority Number)
Potential
Failure Mode
Potential
Effects of
Failure
Condition
and/or
comorbidity
undiagnosed
Patient does
not receive
anticoagulant
when
indicated.
Specimen
misidentified.
Sub-optimal
patient
education
Potential
harmful
patient
outcomes
Failure to
assess
patient’s
understanding
of the
importance of
compliance
Legend:
Potential
Causes of
Failure
S=Severity
Current
Controls
S
O
D
RPN
Two patient identifiers
used.
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4
10
400
Label specimen
vial immediately at
patient bedside.
Two specimens
drawn for
anticoagulation
therapy.
Stress the importance of
medication compliance,
Return demonstration
required.
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5
9
360
Educate/reeducate and
monitor
compliance.
Engage
patient/staff in the
culture of safety.
O=Occurrence
Recommended
Actions
D=Likelihood of Detection
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Analysis: High (Risk Priority Number)
Potential
Failure Mode
Potential
Effects of
Failure
Potential
Causes of
Failure
Current
Controls
S
O
D
Drug, food or
herbal
interactions
not
addressed
Patient
experiences
Signs and
Symptoms of
interaction
No electronic
alerts/ did not
check
references
Active patient list is reconciled with
home med list.
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4
8
Legend:
S=Severity
O=Occurrence
RPN
224
Recommended
Actions
Institute
electronic alerts
related to
Food/Herbal
interactions with
anticoagulants
D=Likelihood of Detection
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Recommended Actions
Safety Measures Implemented
In order to provide standardized care:
1.
Interdisciplinary treatment guidelines/ protocols for anticoagulation
were developed and implemented.
2.
Policy and Procedure was developed and implemented
3.
A comprehensive anticoagulation information package was
developed for patients as well as providers.
4.
CPOE Updated:
a) Typical orders were built for heparin, warfarin and enoxaparin.
b) A “hard stop” was designed as a forced function to obtain
patient weight prior to prescribing anticoagulation therapy
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Safety Measures Implemented
(cont’d)
Safety Measures Implemented
5. Enhancement of Pharmacy Services
a) 2 clinical pharmacists were certified in
Anticoagulation Therapy.
b) A dedicated clinical pharmacist was assigned to the
Emergency Department to monitor enoxaparin.
c) A dedicated clinical pharmacist was assigned to the
Anticoagulation Clinic.
d) All pharmacists in OPD are trained to monitor and
document INR values prior to dispensing warfarin.
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Safety Measures Implemented
(cont’d)
Safety Measures Implemented
6.
7.
8.
Drug Utilization Evaluation (DUE) done on warfarin.
Cardiologist reviews every INR value > 5.
Educational in-services and Town Hall trainings were
held for Physicians, Nurses, Pharmacists and Allied
Health Care Providers
Competencies were developed and assessed
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Performance Measures
Per Protocol
1.
Anticoagulation initiated based on diagnosis indication and
laboratory values.
– Baseline lab performed.
– If patient is on warfarin, therapeutic INR achieved within
2 weeks.
– Patient and family education/counseling on:
a) Medications
b) Diet
– Compliance to follow-up visits in Anticoagulation Clinic.
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Results of the Pilot Project
[ October 1, 2008– November 17, 2008]
1) Number of cases analyzed:
– Unfractionated Heparin
– LMWH
– Warfarin
Total cases
2) Patient’s gender:
-Male
-Female
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65
66
146
62 (42%)
84 (58%)
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Results of the Pilot Project
[ October 1, 2008– November 17, 2008]
3) Most common indication for initial anticoagulation:
– Unfractionated heparin
– LMWH
– Warfarin
DVT/PE
ACS/Unstable Angina
Atrial Fibrillation
4) Patient’s age:
– <40
– 40-65
– >65
12 (8%)
65 (45%)
69 (47%)
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Results of the Pilot Project
[ October 1, 2008– November 17, 2008]
5) Condition(s) that potentially increases the
risk of bleeding
– Age >65
– Hypertension
70 (48%)
74 (51%)
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Results of the Pilot Project
[ October 1, 2008– November 17, 2008]
6) Adverse drug reactions to medication*
– Unfractionated heparin
– LMWH
– Warfarin
Total
*Note:
0/15 (0%)
1/65 (1.5%)
5/66 (7.6%)
6/146 (4.0%)
1 patient INR (5-9) without bleeding
5 patients with epistaxis, therapeutic INR
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JCA’s timeline
• Followed Joint Commission timeline for
implementation of NPSG 03:05:01 by
January 1, 2009
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Next Steps
• Conducted a 3 month study (mid- January to
mid-April) to identify the success of the
processes implemented
• Continue to train staff to reach 100% compliance
• Data is being analyzed and will be presented to
the appropriate committees
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THANK YOU
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