The tracking of allograft tissue from donor to recipient has always been an important part of Northwest Tissue Services activities. At the very start of the program in 1988, we recognized the importance of gathering information about both the uses of transplant tissue and the patients who receive it. Our efforts to educate hospitals to help us have been very successful, and many other tissue banks have similarly patterned their tracking procedures.

The primary instrument used in this tracking is the transplant record that accompanies the tissue. NTC staff encourages each client to return this record following the use of tissue in surgery. Additionally, semiannual requests regarding the disposition of tissues are sent to all clients. The Tissue Services also provides a tracking log to each hospital that facilitates its tracking receipt into and distribution from tissue inventories. Bar-coded stickers on the transplant record can be used in the log to identify the tissue as it is received. Stickers also can be placed in the patient chart to identify the tissue used in the surgery.

EXEMPLARY RECORDS
Thanks to the awareness and cooperation of its hospital partners, the Tissue Services’s return rate has remained high. For 1999 and 2000, it was 95 percent and 91 percent, respectively.

Twenty-five hospitals and surgical centers in Washington, Idaho, and Montana have achieved a 100 percent return rate (see table at right).

NEW FDA REQUIREMENT
Now, the FDA has expressed its expectation that all tissue banks will institute a program to track allografts to the patients who receive them. Indeed, the proposed rule regarding inspection and enforcement states: “FDA considers product tracking to be an essential component of its proposed regulatory system for human cellular and tissue-based products. Should a recipient of such a product contract a communicable disease, tracking would permit appropriate follow-up, such a as an investigation to determine whether the human cellular or tissue-based product transmitted the disease agent and, if so, would permit steps to be taken to prevent the distribution of other similarly infected products. Similarly, if a donor is discovered, post-donation, to have had a communicable disease, tracking would permit an establishment to locate products from that donor. Thus, a tracking system is closely linked to the agency’s regulatory objective of preventing the spread of communicable disease.”*

MORE REASONS TO TRACK
In addition to meeting regulatory requirements, the tracking information allows the Tissue Services to provide some follow-up information to donor families about the types of patients who have benefited from their donations. Donor families gain strength and comfort from the knowledge that many people were helped.

When recipients choose to send thank you letters to their donor families, the Tissue Center is able to easily identify which donors provided the tissues and to send the letters on to the donor families.

Our tracking program satisfies many objectives, not the least of which is compliance with these new regulations that we expect the FDA will finalize. We appreciate the participation of our hospital partners who help us close the loop. Our donor families
appreciate it too.

*Department of Health and Human Services, Food and Drug Administration,  21 CFR Part 1271, [Docket No. 97N-484P], Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement, FDA, HHS, Proposed rule pp36-37]