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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
• Medicine• Nursing• Pharmacy• Laboratory• Dietary• Information Technology• Quality Management• Patient Safety Committee Chair• Patient Safety Committee Officer
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DO
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•Review Heparin, LMWH and Warfarin Protocol clinical guidelines (Draft Completed)
•Work plan will be implemented that identifies adequate resources and a timeline for full implementation – (7/08) Joint Commission
•Five Implementation Strategies were identified to commence work on the high RPN’s from the FMEA – (4/08)
•Multidisciplinary Team formed & FMEA Phase I (1/08)
Process/TimelineDO
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Pilot Testing in 8-100 and Anticoagulation Clinic- (10/08) Joint Commission
Full implementation – (1/09) Joint Commission
•Anticoagulation Clinic established
•Adjustment of system for monitoring and follow up appts. in ambulatory and labs.
•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
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3 mthStudy of theRocess Jan - Apr
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Strategies for FMEA Process• Identified issues from the aspect of
– 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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Adverse Outcomes Related to
AnticoagulationTherapy
Equipment Policies & Procedures
Patient Staff
Pt.’s idiosyncratic response
Equipment failure
Lab info not available
Drug reference not available
Order sets incorrect
No monitoring occurs
Barriers to learning
Pt. information notcomplete
No redundancy built into the process
Pt. does not reportSigns and symptoms
Specimen mislabeled
Wrong weight used
Weight not considered
Contraindications not observed
Indication for anticoagulation not present
Contraindications not checkedProtocol not followed
Wrong pt. selected
Duplicate drug therapy
Wrong med ordered/dispensed/administered
Wrong dose, route, rate or diluent
Allergy info not checked
Drug interactions not evaluated
Order not sentOrder not renewed
Labs not checked/wrong lab checkedLabs not ordered
Ignored alerts
Infusion pump programmed incorrectly
No safeguards built into the process
Prescribing errors not identified/corrected
Drug not available
Safety Alerts not functioning
CPOE system not updated
Computer system down
Existing protocol is not easyTo follow
ComplianceCommunication
CAUSE AND EFFECT
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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 follows-up on “no shows”.
9 7 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
8 6 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
Potential Causes of
Failure
Current
Controls
S O D RPN Recommended Actions
Condition and/or comorbidity undiagnosed
Patient does not receive anticoagulant when indicated.
Specimen misidentified.
Two patient identifiers used.
10 4 10 400 Label specimen vial immediately at patient bedside. Two specimens drawn for anticoagulation therapy.
Sub-optimal patient education
Potential harmful patient outcomes
Failure to assess patient’s understanding of the importance of compliance
Stress the importance of medication compliance,
Return demonstration required.
8 5 9 360 Educate/re-educate and monitor compliance. Engage patient/staff in the culture of safety.
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
Potential Causes of
Failure
Current
Controls
S O D RPN Recommended Actions
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.
7 4 8 224 Institute electronic alerts related to Food/Herbal interactions with anticoagulants
Legend: S=Severity O=Occurrence 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 implemented3. 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 Servicesa) 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. Drug Utilization Evaluation (DUE) done on warfarin. Cardiologist reviews every INR value > 5.
7. Educational in-services and Town Hall trainings were held for Physicians, Nurses, Pharmacists and Allied Health Care Providers
8. Competencies were developed and assessed
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Performance MeasuresPer 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) Medicationsb) 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 15– LMWH 65– Warfarin 66
Total cases146
2) Patient’s gender:
-Male 62 (42%)
-Female 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 DVT/PE– LMWH ACS/Unstable
Angina– Warfarin Atrial Fibrillation
4) Patient’s age:– <40 12 (8%)– 40-65 65 (45%)– >65 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 70 (48%)– Hypertension 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 0/15 (0%)– LMWH 1/65 (1.5%)– Warfarin 5/66 (7.6%)
Total 6/146 (4.0%)
*Note: 1 patient INR (5-9) without bleeding5 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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