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August 2010

Scott Brubaker

Tissue Tracking Failures and Lessons Learned - Hope for the Future

by Scott A. Brubaker
CTBS, Chief Policy Officer, American Association of Tissue Banks

Allograft tissue tracking failures by health care facilities have occurred when tissue banks have issued recalls. In recent years, the expansion of the Joint Commission’s standards for handling tissue, now located in the Transplant Safety Chapter, is helping to close this gap for facilities under their oversight umbrella but it is ultimately up to each facility to comply with Elements of Performance related to complete tracking. Tissue tracking abilities of free-standing, private facilities, such as a number of outpatient surgery centers and physicians’ offices, remains suspect because no regulatory authority requires them to follow tracking protocols for tissue grafts. Tissue banks have historically offered all end users a way to track tissue recipients by issuing implant cards/forms with each distributed graft, but the final step of completion and return has experienced only fair compliance. In modern times, what else can be done to close this gap in allograft recipient patient safety? Use of universal machine-readable labels on allograft tissues is a future possibility but may only occur if this desire is real and expectations are voiced appropriately and effectively.

Imagine for example that you work in the surgical suite of a hospital, in a transfusion service that handles tissue, or possibly in an ambulatory surgery center or in a dentist's office. You are the health care professional receiving a few boxes containing a dozen tissue allografts. Some are refrigerated, some are frozen, and a few are shipped without coolant and stored at ambient temperature. You inspect the different shipping boxes for damage and there is none. You verify that the refrigerated and frozen shipments are received before the date and time posted on the external box label. This is the expected expiration of the refrigerant used to maintain the controlled environmental temperature required for those graft types during transport. Since this expiry was determined using a validated procedure and specific, qualified shipping boxes, you are not obligated to place a thermometer inside these shipments to check the temperature on arrival.

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