Chapter 28

1. Chapter 28 Tissue Banking: A New Role for the Transfusion Service

2. Introduction • Hospital Tissue Banks consolidate, standardize, and centralize the handling of human-derived tissue. • Tasks include qualifying tissue vendors, ensuring proper tissue handling and storage, monitoring temperature, record keeping, and issuing procedures to ensure traceability.

3. History and Overview • 1949: U.S. Navy establishes the first tissue bank • First model for tissue harvest, processing, storage and transplant • Many of its standards are still followed today • National Marrow Donor Program (NMDP) • American Association of Tissue Banks (AATB)

4. History and Overview (cont’d) • 1984: National Transplant Act (NOTA) • Established a national, centralized waiting list for organ recipients and outlawed the sale or purchase of organs • 1990s: Increase in the role of the FDA in tissue banking • Included requirements that donors be screened for Hepatitis B, HIV, and behavioral risk factors

5. History and Overview (cont’d) • 1997: FDA regulatory overhaul led to a more comprehensive approach in three key areas • Preventing the unwitting transplant of contaminated tissues that could transmit disease • Preventing improper handling that may contaminate or damage tissue • Ensuring the demonstration of safety and effectiveness of tissue products

6. History and Overview (cont’d) • In 2001, the FDA proposed that establishments follow cGMP, including • Establishment of Standard Operating Procedures • Quality programs • Record keeping standards • Tracking procedures • Manufacturing establishments register with the Agency and list their products

7. The Hospital Tissue Bank • Common tissues used in surgical procedures include bones, ligaments, tendons, heart valves, skin, veins, cartilage, dura mater, hematopoietic stem/progenitor cells, and corneas/eyes. • The majority of these tissues do not require HLA or blood group matching. • Inventory should consider the “off the shelf” utility of a product, its frequency of use,and expiration date.

8. The Hospital Tissue Bank (cont’d) • In general, the scope of the Tissue Bank is limited to non-vascularized tissue. • Excluded from Parts 1270 and 1271 of the CFR are vascularized organs such as liver, kidney, lung, pancreas, and heart. • In general, these tissues are immediately transplanted and storage is not necessary or desirable.

9. Tissue Bank Oversight • Physician-appointed Medical Director investigates adverse outcomes, participates in lookback investigations, approves SOPs with any deviations, and interfaces with end users. • Development of a tissue committee is recommended with the intent to ensure and promote best practices based on evidence-based medicine.

10. Acquisition of Allografts and Inventory • The Tissue Bank should approve tissue vendors and receive all shipments. • Tissue receipt records must contain, at a minimum • Name and address of tissue supplier • Description of tissue and quantity • Date of tissue receipt • Condition of tissue upon receipt • Expiration date (if applicable) • Tissue Identification Number (TIN)

11. Storage • Storage conditions vary between the different tissue types. • Follow the tissue vendor’s recommendations for each specimen. • The Joint Commission and AATB require that tissue storage and distribution be in conformance with guidelines.

12. Record Keeping and Traceability • Good record keeping is essential to • Demonstrate that SOPs are followed • Track the tissue bi-directionally, from donor to recipient or disposal, and back again • Trace tissue during recalls

13. Quality Assurance (QA) • Goal is to maintain safe, functional,and effective products that meet the needs of the patient and the surgeon. • The QA plan must include written procedures, validation of processes, and investigation of deviations and errors. • The QA plan should verify supplier qualifications, ensure proper training of personnel, and monitor compliance in the Tissue Bank.

14. Qualification of Vendors • The Hospital Tissue Bank must have written guidelines and criteria for the acceptance of a vendor/supplier. • Vendors must be registered with the FDA annually. • The JC requires that Hospital Tissue Banks ensure that suppliers are licensed by state agencies as applicable.

15. Autologous Tissue • Autologous tissue is any tissue that is removed from a patient with the intent to re-implant it at a later date. • Within the operating room, the preparation falls under the regulatory standards of the JC, the AATB, and the Association of peri-Operative Registered Nurses (AORN).

16. Regulatory Overview • A number of organizations are involved in tissue banking and their regulations and standards.

17. Adverse Events • Negative changes, unexpected outcomes, or reactions to the tissue implant • Can be due to infectious disease, failure of the allograft to function as expected, or transmission of malignancy • Necessary to report adverse events for the protection of other patients who may receive tissue from the same donor • Vary with the nature of the tissue involved

18. Adverse Events (cont’d) • Similar to blood donation, the first step in ensuring safe tissue is to screen the donor population for individuals with low risk of disease. • Discovery of the source of tissue failure will lead to recall of other products that may have potential to harm other patients.

19. Adverse Events: Reporting and Investigating • The most basic step in the reporting process is recognition of an adverse event by the clinical staff. • The Medical Director of the Tissue Bank should communicate regularly with the surgeons involved. • Every complaint or suspicion should be taken seriously, even if there is a low chance that the event is related to tissue transplant.

20. Adverse Events: Reporting and Investigating (cont’d) • Immediately following a complaint, the personnel in the tissue bank should look for and quarantine any tissue from the same donor, pending outcome of the investigation. • The tissue supplier must be notified so that steps may be taken to quickly sequester other tissue from that donor.

21. Adverse Events: Reporting and Investigating (cont’d) • Other ancillary investigation should include testing of any unused tissue from the same donor and investigation into the post-operative course of other patients who received tissue from the donor. • The results of the investigation must be reported to all parties involved, including the transplanting surgeon, tissue supplier, hospital risk management department, Tissue Committee, the patient, and the JC.

22. Recalls • Recalls are almost always voluntary. • They may be initiated at virtually any step in the process from the donor to the recipient, even if it is months to years after the tissue has been processed. • When a problem is discovered in the course of an investigation, the FDA may compel the establishment to initiate a recall.

23. Classes of Recalls • Class I: reserved for products that may cause serious harm, health problems, or death if used • Class II (intermediate): for products that may cause temporary health problems or less serious injury • Class III (most common): pertains to products in which a manufacturing irregularity or violation in labeling is discovered, but the product is unlikely to cause harm if used

24. Steps Involved in Recalls • Upon receiving notification of a recall, the Hospital Tissue Bank must verify that the product is or was in inventory, determine the disposition of any and all tissue included in the recall, and quarantine any unused tissue.

25. Steps Involved in Recalls (cont’d) • The JC and AABB require that recipients of tissue from donors that are subsequently found to be positive for HIV, Human T-cell Lymphotropic Virus (HTLV) type I or II, viral hepatitis, or other known infectious agents transmissible by tissue must be notified.