For Blood / Biologics

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
The widened availability of tissue allografts has encouraged new clinical uses and brought attention not only to their effectiveness and advantages but also to their drawbacks, side effects, and complications. One of its drawbacks is the potential for disease transmission. Transmission of infectious disease from the tissue allograft to the recipient has been a serious complication of tissue transplantation but new standards have reduced this risk greatly. Bacterial, fungal, and viral infectious diseases as well as Creutzfeldt-Jakob disease have been transmitted by several different types of tissue allografts. These infections can arise from tissue allografts due to infected donors or because of post-mortem contamination acquired during surgical removal of tissue from donors or during tissue processing or packaging.

Preventing Transmission of Disease
Preventing donor-to-recipient viral disease transmission relies heavily on the selection of safe tissue donors by the tissue bank . Tissue donor evaluation selection steps include an extensive medical history and behavioral risk and physical assessment so the selected donors are at low risk of transmissible infections. They also are tested for the same infectious disease agents as are blood donors.

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
In most hospitals tissue allografts are acquired and stored by the operating room staff but in more and more hoapital blood banks have been handling both blood and tissue allografts. A hospital blood transfusion service has special expertise to serve as a hospital tissue transplantation service that acquires stores and issues human tissue allografts. More that at any other site within the hospital, it has experience in providing an adequate supply of human-derived materials that are perishable, potentially infectious, sometimes in short supply and must be stored properly, fully traceable, compatible, safe and effective and used appropriately.

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
Hospital tissue services must maintain records so that all steps are recorded concurrently with the performance of each step when handling tissue. Records must be accurate, indelible, and legible and must identify the person performing the work and the date. Records should be as detailed as necessary to provide a history of the work performed. They provide evidence that the SOPs were followed and link the particular tissue allograft to the patient who received it. Tissue service record keeping should permit bi-directional traceability of all tissues from the donor and tissue supplier to the recipients or other final disposition, including the discard of tissue.

“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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FDA Link

  • FDA Releases Human Tissue Task Force Report
    Link

Additional Publications

  • Eisenbrey B Eastlund T. Guidelines for managing tissue allografts in hospitals Bethesda, MD: AABB. 2006

  • Eastlund T. .Bacterial infection transmitted by human tissue allograft transplantation Cell and Tissue Banking 2006,7: 147-166

  • Eastlund T. Tissue and organ transplantation and the hospital tissue transplantation service. In: Roback J, ed. AABB Technical Manual. 16th edition. Bethesda, MD: AABB. 2008 (in press)

  • Eastlund, Eisenbrey, B. Handbook for Managing Tissue Allografts in Hospitals. Bethesda, MD: AABB. 2008 (in press)