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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

PLA

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ACT

ST

UD

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DO

PLA

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ACT

ST

UD

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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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ACT

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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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