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Tissue Banking: Regulations, Operations and Medical Oversight
An Interview with Ted Eastlund, M.D., by Robyn Barnes
For most of us in the public, transplantation means organs saving lives of unfortunate patients who would otherwise die. Hidden from the limelight is the widespread generosity of the public donating not just organs but also tissues after death and the widespread ongoing practice of transplanting these tissues such as bone, tendons, corneas, heart valves and skin.
Over 1.5 million human tissue allografts (the transplant of an organ or tissue from one individual to another of the same species with a different genotype) are transplanted annually in the United States. These tissues are used to improve the quality of life for patients, and for some, such as patients with a failing heart or a patient with serious burns, heart valve and skin allografts can be life saving.
Like blood, tissue used in allografts must be held to rigorous safety standards. In an AABB report entitled “Guidelines for Managing Tissue Allografts in Hospitals,” the authors state that there are infectious diseases that can be transmitted by tissue allografts that need to be recognized and investigated.
“Tissues have to be safe and effective,” says one of the report’s authors, Dr. Ted Eastlund, associate medical director at LifeNet Health and a veteran of the blood and tissue industry. “Safety issues usually arise in one of three areas: the evaluation and screening of donors, blood testing, and tissue bank processing where tissues go through disinfection or sterilization.”
Disease Transmission through Tissue Transplantation
Preventing Transmission of Disease
Tissue banks prevent bacterial and fungal contamination of tissues by using aseptic surgical technique, equipment and supplies when removing the tissue from the donor and when processing and storing the tissue at the tissue bank. Tissue banks apply disinfection and sterilization steps to most tissue allografts. Despite careful donor selection steps, disinfection and sterilization steps, the risk of transmitting infection remains. The incidence of transplant- transmitted infection is unknown and the studies needed to determine this have not been performed.
Hospital Tissue Transplantation Services
AABB standards include requirements for hospitals handling tissue allografts and if the hospital blood transfusion service has a role in handling tissue allografts these standards must be followed. AABB requires written procedures, recordkeeping to ensure traceability, proper storage and investigation of reports of adverse outcomes. The Joint Commission (formerly known as the Joint Commission for Accreditation of Health Care Organizations) has accreditation requirements that apply to hospitals that acquire, store and release tissue allografts for transplantation in their facility. The Joint Commission standards require that hospitals assign oversight responsibility for handling tissues within the hospital, use standardized procedures in all tissue handling steps, maintain traceability of all tissues, and have a process for investigating and reporting adverse events. AABB has published guidelines to aid hospitals in interpreting and meeting the requirements of The Joint Commission and AABB.
Federal regulations established by the US Food and Drug Administration (FDA), generally pertain to tissue bank processors and tissue suppliers that recover, process, store and distribute tissue. The FDA requires that tissue banks and tissue suppliers are registered with the FDA and the FDA periodically inspects them. Hospitals can learn about their tissue supplier’s regulatory compliance since FDA inspectional findings, recalls and MedWatch reports of tissue allograft adverse event can be obtained from the FDA.
“There can be failures that threaten safety,” Dr. Eastlund says. “Sometimes the failures are addressed by new government regulations. Sometimes they are addressed by the hospitals or the tissue banks. Failures must be recognized, investigated and prevented because patient safety is at risk.”
Tissue Allograft Traceability and Record-Keeping
“Hospitals handle tissues every day. They acquire, inspect and store tissues; they have a major role in investigating any adverse outcome in the allograft process. During the last ten years, there has been increasing preoccupation with tracing where a tissue came from. Tissue banks need to be able trace the tissue from its storage unit to the hospital that used it and to the patient who received it,” he continues. And if a patient develops an infection that could have been caused by a contaminated allograft, the hospital records need to document where it came from so the complication can be reported to the tissue bank and investigated
In the past, some hospitals have had inadequate record keeping that failed to permit obtaining the identities of allograft recipients. When a tissue allograft causes an infection in a patient, the other allografts produced from the same donor should also be evaluated for contamination. If they have already been transplanted, surgeons and recipients should be notified of the need for an evaluation for infection. It has not always been possible to identify all of the tissue allograft recipients during several previous recalls due transplant-related infections.
“You can see that record keeping and document management are very important in this process. If a patient who received an allograft experiences an adverse event, we need to know everything we can about that tissue to determine if it is the source of the problem. Was there a problem with the donor? Did infection occur at the hospital? Did the patient get the infection from another source, not the allograft? Who transported the tissue and how was it transported? All of this information must be traced and considered,” he says.
In 2005, The Joint Commission set new requirements for hospitals in the USA to maintain traceability records for appropriate storage and for investigation and reporting of adverse outcomes associated with tissue allograft use. It previously had standards for recordkeeping and storing tissues in laboratories but not for operating rooms. These standards now affect all departments of the hospitals regardless of where tissues are handled. The tissue supplier is responsible for traceability from donor to the hospital and the hospital is responsible to ensure traceability from receipt of the tissue to the recipient.
“In my opinion, the hot button in this tissue bank profession revolves around focusing on how hospitals handle tissue and improving this process. They need fool-proof methods of traceability. This is an area of tissue banking that only recently is getting the attention it needs and it is so important to patient safety.”
Dr. Eastlund is Associate Medical Director at LifeNet Health, Virginia Beach Virginia. He was the Chair of the Histocompatibility and Transplantation Committee of the American Association of Blood Banks in the 1990’s and currently is a member of the AABB Tissue Committee and the AABB Standards Committee. He will be a featured speaker in the Tissue Management Track at the AABB Spring Conference, slated for March 28 -29 at the Buena Vista Palace Hotel & Spa in Orlando. For more information or to register, go to http://www.aabb.org/Content/Meetings_and_Events/Spring_Conference/sprconf.htm.
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