Bridging the Gap Between Biologics & Compliance

1. Bridging the Gap Between Biologics & Compliance

2. Grant Funds Provided by Continuing Nursing Education Credit Provided by

3. Objectives • Define biologics • Describe the regulations & standards related to biologics • Discuss problem prone areas associated with tissue management in the OR setting • Discuss best practices for tissue management

4. Defining Biologics • Autograft • Allograft • Xenograft • Synthetics • Recombinant Human Growth Factors Bioengineered Grafts – biologic tissue that is combined with synthetic material for implantation

5. Regulations and Standards

6. U.S. Food & Drug Administration • Center for Biologics and Research (CBER) • Requirements for human tissue banks (HCT/Ps) • HCT/Ps are Human Cellular and Tissue Based-Products • Must register w/ the FDA (2001) • Requirements for donor suitability • Must follow the Good Tissue Practices (2005) • Rules for record keeping • Authority for FDA to inspect tissue banks • Ability to recall or destroy tissue • Medical Devices…..510(k), PMA

7. American Association of Tissue Banks (AATB) • Voluntary accreditation of human tissue banks • Three areas of accreditation • Retrieval • Processing • Storage/Distribution • www.aatb.org

8. The Joint Commission (TJC)Transplant Safety • Voluntary accreditation of hospitals and ASCs • Apply to human and nonhuman cellular based transplantable & implantable products • Tissues (allograft & autograft) • Medical devices (allograft & xenograft) • Three areas of focus: • Standardized procedures to acquire, store, and issue tissue • Tissue tracking • Investigating adverse events

9. AORN: Recommended Practices for Surgical Tissue Banking • Guidelines for utilization of human tissue in the surgical setting • Recommendations for establishing an optimal level of practice as it relates to allograft tissue • Synthesized recommendations of FDA, AATB and The Joint Commission

10. American Association of Blood Banks (AABB) • Created to assist hospitals in the transition toward centralizing tissue banks and services within blood banks and transfusion centers in the hospital • Utilizes TJC standards as a guide

11. Problem Areas in Tissue Management • Receipt • Storage • Tissue Handling • Other

12. Verification Recommended temp Integrity of package Bar code/serial numbers are accurate Personnel receiving and verifying tissue Receipt • Date & time • Tissue description • Tissue serial number • Expiration date JC Standards: Transplant Safety TS.03.01.01, EP 6,7 JC Standards: Transplant Safety TS.03.02.01 EP 3

13. Receipt • Is the temperature acceptable? • Residual Coolant • e.g. dry/wet ice • Validated shipping container • Documentation from supplier • Within validated timeframe • Package Integrity • Seal intact • No physical damage • Labels/barcodes are present

14. Vendors • Distributors of tissue must register annually with the FDA • Some states require licensure • TJC requires healthcare facilities to verify registration & licensure • Reps carrying allograft into the OR may be a violation of this requirement • Documentation of registration • Documentation of receipt of tissue

15. Storage • Monitoring and recording • Automated delivery • Freezer maintenance

16. Monitoring & Recording Requirements • Maintain daily storage logs for freeze-dried tissues requiring a controlled environment • Continuously monitor the temperature of freezers & refrigerators • Record at least daily • Ensure that all storage equipment has functioning alarms • Alarm to area manned 24/7 • JC Standards: Transplant Safety (TS.03.01.01, TS.03.02.01, TS.03.03.01) • AORN Recommended Practices for Surgical TB. AORN Journal, February 2006. • AABB Guidelines for Managing Tissue Allografts in Hospitals

17. Handling • Check graft & package • Integrity • Expiration date • Use aseptic technique • Follow instructions on package insert

18. Handling • Who handled? • Dates, times & staff • How prepared? • Per manufacturer’s instructions • Save instructions • Solutions used? • Lot # and expiration • Include in patient’s medical record • Tissue type, unique identifiers • Return tissue tracking forms to allograft tissue bank

19. Record Keeping • All records must be stored for minimum of ten years, but may be longer in your state, including: • Tissue supplier • Original numeric or alpha-numeric donor and lot identifiers • Recipient name or the final disposition of each tissue • The expiration dates of all tissues • All tissue usage information cards are completed and returned to the tissue supplier • JC Standards: Transplant Safety (revised TS.03.02.01) • AORN Recommended Practices for Surgical TB. AORN Journal, February 2006.

20. Transporting Between Facilities • FDA registration as a tissue bank is imperative to distribute tissue to another facility • Exceptions • Facilities that are physically adjacent within the same healthcare organization

21. Must be able to trace the tissue From the donor to the recipient From the recipient to the donor Report adverse events to supplier and possibly FDA The Joint Commission requires a policy For more information: FDA Current Good Tissue Practices, 2005 AABB Guidelines for Managing Tissue Allografts in Hospitals, 2006 Steelman & Schlueter (2007). Managing a tissue recall in a large academic hospital. Transfusion. 47(5):927-34. Recalls & Adverse Events

22. Verification of tissue source facilities FDA registration & state licensure Verification of package upon receipt Documentation required Temperature recording & monitoring Recording daily for ambient and refrigerated tissue Continuous temperature monitoring for freezers & refrigerators Continuous recording is not required Top Three Concerns: TJC

23. Algorithm for Tissue Management • Define responsibility • Develop a team • Identify all biologics used • Map the process, “Standardize” • Review the requirements • Create a policy

24. Bridging the Gap • Every Joint Commission accredited facility MUST have a tissue policy • Goal is to standardize tissue management within all areas of the facility • Test by tracking serial numbers / patient implants • Adverse Events • Documentation is the most important piece of this process

25. Tissue Tracking Options • Manual data capture and recording • Hand written paper forms • Excel Spreadsheets • Forms from tissue bank • Automated data capture in automated system • Data transfer or bar coding • Tracking and data storage in automated platform

26. Manual Paper Tracking • Inconsistent staff participation • Hand written data can be difficult to track • Legibility • Searching for old data • Conducting a tissue recall (6 mo. vs. 2 min.) • Stickers or barcode labels can improve accuracy • May fall off manual sheets • Multiple staff involvement • Backing up data • Errors

27. The “Ideal” Tracking Option Tracks allograft, autograft and non-tissue items Integrates with existing health information system Traces product through final disposition Utilizes barcodes, scanners, RFID tracking Prompts for expiring tissue and performs inventory reconciliation Does not burden hospital IT department Adverse event and recall tracking system Automatically completes tissue usage forms

28. Automated Tracking • Real-time • Web-based, automated • Manage and track tissue receipt, transfer, issuance, validation, implantation or disposal • Monitor every person that interacts with the tissue • Most systems allow hospital-specific customization and real-time access from any location within the facility

29. Automated Tracking: Time Savings • May allow self-population of data with a barcode scan • Implantation data transferred electronically to the tissue supplier • Instant identification of all tissue inventory by serial number, code, or type

30. Automated Tracking: Cost Savings • May prevent the use of expired tissue through a notification system • Ordering process is streamlined with the facility-established inventory levels • Labor hours are significantly reduced with automated tracking versus paper tools • Assist with rotation of inventory and notifications for inventory that is about to expire

31. Automated Tracking: Compliance • Automatic tracking from purchasing through implantation • Reports are simplified and customized • Recalls conducted efficiently and completely • Ideal tracking systems will update their platform as The Joint Commission and FDA requirements change

32. Any Questions?

33. Evaluation / Registration Please remember… Complete your registration and evaluation forms in the back of your booklet Return them to your presenter