Responding to Recalls LUHS 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

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

AIM Statement Develop and implement systematic approach to handling recalls throughout LUHS 1. 1.Select a single system for recall and alert compliance, documentation and notification for LUHS 2. 2.Decrease time from notification of the recall to completion of the required recall activities 3. 3.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

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

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

Reports- Average Number of Alerts Per Week Product DomainVolume Food11.2 Medical Supplies8.6 Pharmaceutical Products8.1 Laboratory Supplies5.6 Children’s Consumer Products4.4 Bio-Medical Devices4.2 Engineering and Facilities3.2 Radiology Products3 Tissue1.44 Veterinary Products.77 OR Products.66 Biologics.33 Blood Products.11 Information Systems.11 Other Products/Supplies.11 Total52.11 Confidential: For Quality Improvement Purposes Only

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

Average Day to Close Confidential: For Quality Improvement Purposes Only

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

Next Steps 1. 1.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