Team Leaders: Jen Carlson, Environmental Health & Safety Mike Uribe, Procurement Services

1. Responding to RecallsLUHS uses new tool and team to quickly catch recalled medical devices, products and drugs Team Leaders: Jen Carlson, Environmental Health & Safety Mike Uribe, Procurement Services Anne Porter, Center for Clinical Effectiveness Participating Departments: Pharmacy, Clinical Engineering, Procurement Services, PP&G, Food & Nutrition, Ambulatory Services, Radiology, Lab, Environmental Health & Safety, Information Systems and Center for Clinical Effectiveness Confidential: For Quality Improvement Purposes Only

2. The Opportunity….. • Identify and eliminate multiple sources of entry for recalls and alerts • Enhance communication and collaboration for the recall process across LUHS • Improve documentation and satisfy compliance requirements for alert handling • Active Management Control & Oversight Confidential: For Quality Improvement Purposes Only

3. AIM Statement Develop and implement systematic approach to handling recalls throughout LUHS • Select a single system for recall and alert compliance, documentation and notification for LUHS • Decrease time from notification of the recall to completion of the required recall activities • Establish active management and control of process • Bringing Responsibility Back to the Front Line • Taking responsibility for Recalls to the Top Confidential: For Quality Improvement Purposes Only

4. Solutions Implemented • Developed FMEA Team • Secured funding to purchase web-based tracking system (RASMAS) •  Identify responsible coordinators for each domain: • Biologics • Biomedical Devices • Blood Products • Children’s Consumer Products • Engineering & Facilities • Food • Information Systems • Laboratory Products • Medical Supplies • OR Products • Other Products • Pharmaceuticals • Radiology Products • Tissue Confidential: For Quality Improvement Purposes Only

5. LUHS Implementation Plan • Establish Coordinators for each domain (include 17 offsite locations) • Coordinators assigned responders for specific domain • Trained all domain responders & coordinators on system Do • Implementation- March 3, 2008 Study • Daily reports generated to domain coordinators • Reports are escaladed to facility manager if response is not timely • Reports are monitored monthly by LUHS Safety Sub-Committee Act • Follow-up meeting to discuss feedback and any process improvements recommendations Confidential: For Quality Improvement Purposes Only

6. Reports- Average Number of Alerts Per Week Confidential: For Quality Improvement Purposes Only

7. Alert Volume Within First Month of Implementation Confidential: For Quality Improvement Purposes Only

8. Average Day to Close Confidential: For Quality Improvement Purposes Only

9. Analysis The implementation of RASMAS has resulted in: • More efficient workflow processes • Increased Patient Safety due to the rapid dissemination of alerts • Active Management Control & Oversight Confidential: For Quality Improvement Purposes Only

10. Next Steps • Develop LUHS policy addressing recall procedures & responsibilities for all 11 domains 2. Establish effective communication mechanisms for LUHS patients and staff on “high alert” recalled items (i.e.: heparin) 3. Continue to monitor recall compliance and focus on problematic domains Confidential: For Quality Improvement Purposes Only