Tissue Transplantation Services: Coming into Compliance

1. Tissue Transplantation Services: Coming into Compliance Phillip J. DeChristopher, MD, PhD, Chair Anne Link, MT(ASCP), Tissue Coordinator Meg Kim, RN, OR Manager Committee Representatives from: Russo Operating Room Ambulatory Surgery Center Oral Health Center for Clinical Effectiveness Clinical Laboratories Hospital Administration Materials Management Patient Safety and Risk Management Purchasing Confidential: For Quality Improvement Purposes Only

2. Aim Statement • Tissue Transplantation is a common practice in Loyola’s OR, ASC, and Oral Health Center. • In July 2005, the FDA and The Joint Commission (TJC) introduced new regulations and standards to ensure safe practices for tissue management. • New systems were required to: • Acquire, receive, store, and issue tissue • Trace the use of tissue bi-directionally • Investigate and follow-up on adverse events related to tissue use and donor infections • The goal of this project was to standardize processes for tissue management at Loyola to ensure compliance with federal regulations and TJC standards. Confidential: For Quality Improvement Purposes Only

3. Project Measures of Success To achieve a minimum of 90% compliance with the following measures: Tissue Receipt • Package integrity and transport temperature are documented for incoming tissue Tissue Tracking • Tissues received are documented on the incoming tissue log Tissue Storage • Daily temperatures for equipment and storage spaces are documented and corrective action is taken when temperatures are out of range Tissue Preparation • Materials used to prepare and/or process tissue are documented Confidential: For Quality Improvement Purposes Only

4. The program manages over 70 different types of tissue products from 40 vendors. Services that regularly use tissue include: • Cardiovascular • Neurology • Ortho • Burns / Plastics • General Surgery • Ophthalmology • Oral Surgery Confidential: For Quality Improvement Purposes Only

5. Solutions Implemented • Formed a multi-disciplinary Tissue Services Committee • Created/hired a new position - Tissue Coordinator • Consolidated tissue storage in the main OR, ASC and Oral Health • Replaced an OR freezer • Installed and validated an electronic, continuous-temperature monitoring and alarm system • Developed and implemented a Tissue Services Policy Manual • Implemented standardized processes permitting traceability and auditing of tissue transplanted, including ongoing reporting of incidents or non-conformances Confidential: For Quality Improvement Purposes Only

6. Jan 07: All tissue is checked July 07: Packing slips for 26 items were not scanned/saved Confidential: For Quality Improvement Purposes Only Prior to 2007: Data applies only to certain frozen bone Jan 07- Present: Data applies to all tissue

7. Jan 07: All tissue is logged Confidential: For Quality Improvement Purposes Only Confidential: For Quality Improvement Purposes Only Confidential: For Quality Improvement Purposes Only Prior to 2007: Data applies only to certain tissue Jan 07-Present: Data applies to all tissue

8. June 07: Implementation of the Rees Temperature Monitoring System Jan 07: Began temperature monitoring for all tissue storage devices Confidential: For Quality Improvement Purposes Only Prior to 2007: Data applies only to refrigerated and frozen tissue Jan 07-Present: Data applies to all tissue

9. Jan 07: Began monitoring for all tissue Confidential: For Quality Improvement Purposes Only Prior to 2007: Data applies only to autologous bone Jan 07 – Present: Data applies to all tissue

10. Analysis & Outcomes • The program has achieved a ≥ 90% target for all measures of success • LUHS Tissue Services had a successful 2007 Joint Commission survey with no recommendations! Confidential: For Quality Improvement Purposes Only

11. What’s Next? • Acquire a tissue tracking software system which will enable us to effectively and efficiently document, manage, track and trace our tissue inventory usage • Continued oversight of tissue management by the Tissue Services Committee. Thanks to all those involved in making our tissue program a success and in full compliance with Joint Commission Standards! Confidential: For Quality Improvement Purposes Only

12. Tibia Femoral Head Cervical Spacers Achilles Tendon

13. Injectable Bone Putty Cancellous Bone Chips Crushed Cancellous Bone

14. Pulmonary Valve Allograft Aortic Valve Allograft Aortic and Mitral Valves – bovine or porcine source

15. Regenerative Tissue Matrix – derived from human skin Cornea Tympanic Membrane