Failure Mode Effect Analysis on Anticoagulation Across the Continuum

1. Failure Mode Effect Analysis on Anticoagulation Across the Continuum May 2, 2009 Anthony Nolosco, MS., R.Ph. Associate Director, Pharmacy Woodhull Hospital

2. 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. 2

3. MULTIDISCIPLINARY TEAM • Medicine • Nursing • Pharmacy • Laboratory • Dietary • Information Technology • Quality Management • Patient Safety Committee Chair • Patient Safety Committee Officer 3

4. Process/Timeline 3 mthStudy of the Rocess Jan - Apr 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. • Work plan will be implemented that identifies adequate resources and a timeline for full implementation – (7/08) Joint Commission • 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) 5

5. 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

6. CAUSE AND EFFECT 4

7. Analysis: High (Risk Priority Number) Legend: S=Severity O=Occurrence D=Likelihood of Detection 6

8. Analysis: High (Risk Priority Number) Legend: S=Severity O=Occurrence D=Likelihood of Detection 7

9. Analysis: High (Risk Priority Number) Legend: S=Severity O=Occurrence D=Likelihood of Detection 8

10. Recommended Actions Safety Measures Implemented In order to provide standardized care: • Interdisciplinary treatment guidelines/ protocols for anticoagulation were developed and implemented. • Policy and Procedure was developed and implemented • A comprehensive anticoagulation information package was developed for patients as well as providers. • CPOE Updated: • Typical orders were built for heparin, warfarin and enoxaparin. • A “hard stop” was designed as a forced function to obtain patient weight prior to prescribing anticoagulation therapy 9

11. Safety Measures Implemented(cont’d) Safety Measures Implemented 5. Enhancement of Pharmacy Services • 2 clinical pharmacists were certified in Anticoagulation Therapy. • A dedicated clinical pharmacist was assigned to the Emergency Department to monitor enoxaparin. • A dedicated clinical pharmacist was assigned to the Anticoagulation Clinic. • All pharmacists in OPD are trained to monitor and document INR values prior to dispensing warfarin. 10

12. Safety Measures Implemented(cont’d) Safety Measures Implemented • 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 11

13. Performance MeasuresPer Protocol • 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: • Medications • Diet • Compliance to follow-up visits in Anticoagulation Clinic. 12

14. Results of the Pilot Project [ October 1, 2008– November 17, 2008] 1) Number of cases analyzed: • Unfractionated Heparin 15 • LMWH 65 • Warfarin 66 Total cases 146 2) Patient’s gender: -Male 62 (42%) -Female 84 (58%)

15. Results of the Pilot Project[ October 1, 2008– November 17, 2008] • Most common indication for initial anticoagulation: • Unfractionated heparin DVT/PE • LMWH ACS/Unstable Angina • Warfarin Atrial Fibrillation • Patient’s age: • <40 12 (8%) • 40-65 65 (45%) • >65 69 (47%)

16. Results of the Pilot Project[ October 1, 2008– November 17, 2008] • Condition(s) that potentially increases the risk of bleeding • Age >65 70 (48%) • Hypertension 74 (51%)

17. 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 bleeding 5 patients with epistaxis, therapeutic INR

18. JCA’s timeline • Followed Joint Commission timeline for implementation of NPSG 03:05:01 by January 1, 2009 13

19. 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

20. THANK YOU 14