A transfusion medicine physician from New England asks how the different aspects of tissue banking is coordinated. In her facility, there are three separate "tissue banks"/"tissue dispensing services": 1) the Blood Bank, responsible for autologous tissue (i.e. bone flaps), frozen allogeneic orthopedic tissue, and vessels that accompany livers for transplantation; 2) the OR, responsible for freeze-dried bone products kept at ambient temperatures; and 3) the Cardiac Center, responsible for heart valves. At her hospital, some believe that the Blood Bank should be responsible for all regulatory issues relating to tissues, while the surgeons (cardiac, orthopedic, etc.) should have "control" of the tissues regarding location and dispensing.

Given that there are a variety of ways to coordinate the process, how are other facilities managing their tissues and ensuring they are in compliance with current regulations? Do other institutions have a designated Operating Room Tissue Coordinator that is responsible for creating, implementing, and maintaining their tissue/quality program? How is the Blood Bank/Transfusion service involved?

The following comments have been received.

ADDENDA Aug. 9, 2006

1. Dr. Brad Eisenbrey, Chairperson of the AABB Tissue Committee and HLA Laboratory Director at Gift of Life Michigan (attribution used with permission) reports that there are a number of current and forthcoming resources for hospitals for managing tissues. AABB members who attended the 2005 AABB Annual Meeting in Seattle can download the presentations from the Tissue Program and the AABB Tissue Management Guide will be available for purchase at the 2006 AABB Annual meeting in Miami. In addition, the Tissue Committee is sponsoring a session on hospital tissue management and regulatory issues at the 2006 AABB Annual Meeting. Furthermore, the AABB Consultation Service has offered their services to help hospitals meet the new JCAHO and updated AABB Standards for tissue management. The AABB Tissue Committee also has subject matter experts from hospitals with "dispensing services," AATB and/or EBAA accredited tissue banks, JCAHO and hospital blood bank directors and tissue coordinators who have dealt with the issues.

Dr. Eisenbrey continues saying that JCAHO requires that there be oversight and responsibility for all the tissues transplanted in the accredited facility but does not dictate a system or identify who should have the responsibility. Tissue distribution can be decentralized but that makes management much more difficult. A centralized system following the blood bank model allows for a single point of entry and distribution for all of the tissues in the facility. Inventory management, tracking and traceability is much easier. This model works whether the single point is the blood bank, pharmacy or operating suite. The obvious advantage of the blood bank is the comfort with regulatory issues, recalls, tracking, inventory management, storing products at room, refrigerator, freezer and liquid nitrogen temperatures, and a pre-existing system (blood products) which can easily be adapted to the new products (tissues).

Finally, he reports that 21CFR1271 treats hospital tissue services as consignees ("end users") of tissues and many regulatory issues do not apply. Everything changes if the hospital collects, processes, and distributes tissues. If the hospital sends tissues (bone flaps, vessels, valves, etc) to other hospitals on anything other than a very rare basis, the institution needs to register with the FDA as a tissue manufacturer and is then subject to full regulatory authority. Another good argument for bringing responsibility for the tissue program to the blood bank.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator