Tissue oversight in hospitals: the role of the transfusion services (2007)

Several important events have occurred over the past few years that have led hospitals and hospital transfusion services to question the structure, function, and “location” of tissue banks in the hospital environment. These events include nationally publicized recalls,1-6 infectious disease transmissions by tissue,1,7-10 and increased regulatory efforts of the Food and Drug Administration (FDA). These events, in part, also led AABB leadership to add “tissue” as a priority, create a tissue task force,11 expand the Cellular Therapies Steering Committee (now called the HCT/P Committee following the term devised by the FDA—Human Cell, Tissues, and Cellular and Tissue-Based Products), publish Guidelines for Managing Tissue Allografts,12 and support survey investigations into the appropriate role of the hospital blood bank in the tissue arena. In this issue of TRANSFUSION, Kuehnert and colleagues13 report the results of one such survey of AABB institutional hospital members, which leads to a number of important and timely conclusions regarding the “location” of tissue services in hospitals. In effect, hospital administrators and blood bankers are coming to the long considered conclusion that the only way to provide excellent tissue services in a way that mitigates legal, financial, and regulatory liability14 is to centralize tissue banks and/or tissue services under the auspices of the hospital transfusion service. This conclusion, in turn, creates a number of resource challenges for the current transfusion service specifically in terms of human, financial, and physical plant resources. Also, unique considerations as to the definition of a tissue versus organ or cellular elements used for transfusion and cellular therapies create additional challenges, some of which are only recently coming to light. Indeed, according to one noted authority, “most hospital blood bankers were unaware of the volume and extent of human tissue use within their institutions until the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) published updated Standards in 2005, effective in July 2005.”15 Indeed, increased attention has been brought to the tissue arena by the American Association of Tissue Banks (AATB), the FDA and current good tissue practices (cGTP), JCAHO, the Eye Bank Association of America, and now by AABB.16-18 Infectious disease transmission from allogeneic and autologous tissue transplantation is not new or surprising and has occurred in a significant number of patients over the past decade. Infectious agents such as HIV, hepatitis C, Clostridium spp. Group A streptococcus, Candida albicans, and Creutzfeldt-Jakob disease have received wide attention.13 Moreover, infections not historically associated with transfusion, including West Nile virus, rabies, and HHV-8, have been shown to be tissue transmitted and the latter has been associated with carcinogenesis in the recipient.8,20 Recognition of the degree of tissue-transmitted infection has led to medical and regulatory concerns about the standards for organ, tissue and cell processing, manipulation, storage, transportation, and tracking—the latter elements being traditionally associated with the functions and sphere of knowledge of both hospital transfusion services and the AABB. These concerns were highlighted by an apparent lack of adequate accounting and tracking and/or tracing of donor procurement by tissue banks and hospital tissue services that allowed products potentially (if not actually) contaminated to be distributed to US hospitals, thus becoming the subject of a nationally publicized recall.21 Most readers will remember the specific case concerning the release of tissue from a New Jersey dentist now associated with both civil and criminal actions acclaimed in the media in 2005.21 The timing of this infamous tissue release was notable, given that the JCAHO had, on July 1, 2005, approved storage and issuance standards, requiring hospitals to implement specific written procedures, traceability methods, and investigative plans to examine adverse events. The FDA had also provided written regulations that guide tissue banks and tissue processors in the preparation and distribution of all human tissue. Those regulatory initiatives led the AABB to issue specific guidance for hospitals to manage and oversee the use of tissue in accredited facilities. Although the JCAHO and FDA texts do prescriptively delineate what hospitals must do regarding written procedures, traceability, and plans for investigating adverse events to be considered “in compliance,” specific guidance on who should ultimately be responsible for tissue services within an establishment—such as which group and/or department and how tissue oversight and management should transpire within the hospital—were not specifically addressed. Nonetheless, JCAHO standards emphasize that a single entity must track transplanted tissue in JCAHO-accredited facilities.16 Similarly, the FDA provides clear instructions to tissue banks and processors regarding approach to ordering, receiving, and transplanting these types of tissues.18 Finally, although AABB guidelines more specifically address how tissue services shouldbe managed in hospitals, they also do not explicitly identify a specific department within a hospital to be responsible for tissue banking.19 In this month's issue of TRANSFUSION, the article by Kuehnert and colleagues13 reports the diverse responses given by hospital institutional members of AABB surveyed on tissue bank responsibilities and hospital department participation, as well as their opinions and views on the involvement of AABB in this evolving process. The results of the electronic survey revealed that greater than two-thirds of respondents felt that AABB should have a key role in leading the charge to centralize tissue management and oversight within hospital transfusion services. The authors of this editorial assert that the hospital transfusion service should be the primary provider of, and responsible for the oversight of, tissue services in hospitals. We further advocate for AABB involvement in these processes. In this regard, tissue “fits” well into the hospital transfusion service environment and sphere of recognized expertise in the hospital and in AABB's growing realm of activities. Over the past decades, in part due to regulation and in part due to a change in approach to quality and quality systems, blood banks and their personnel have developed the infrastructure to perform: 1) vendor validation and qualification, 2) purchasing, and 3) inventory management, including receiving, storage, transportation, tracking and traceability, and issuance. Consequently, transfusion services have developed the experience and tools, as well as the ability to coordinate with multiple entities such as blood donor centers, hospital purchasing departments, and various hospital departments in the supply and accountability of products to clinics, emergency rooms, and surgical and recovery suites. Additionally, blood banks have become known in hospitals as well equipped to design and implement quality programs, including the ability to track blood components from “donor to patient and back,” and investigate adverse outcomes in patients. Indeed, investigating a transfusion-transmitted infection in a blood recipient requires open communication with physicians, surgeons, and infection control services. Additionally, the blood bank has long-standing relationships with numerous hospital services (surgery, emergency rooms, intensive care units, etc.) around storing, managing, and issuing of blood products in an efficient and expeditious manner. In sum, the infrastructure once created and now fully developed for transfusion services to effectively manage and oversee the issuance of blood components for hospitalwide use can be capitalized upon to more effectively control tissue services in the hospital. In the article by Kuehnert and coworkers, respondents who disagree with the process of centralization into the blood bank environment are concerned that the required resources needed to bring this service to the hospital transfusion service would overextend current capabilities. Although the centralization of tissue services seems to be a logical and natural process, we recognize that the transition will not be a seamless one. It is vital that hospital administrators, blood bank managers, and transfusion medicine specialists assess their institution's particular tissue services for transplantation. Once acquired, this information will provide guidance about: 1) type and amount of equipment, 2) staffing and personnel resources, 3) physical space and the relation of the location of tissue services to surgical suites and other hospital departments receiving human tissue, 4) specific needs of physicians in varying specialties, 5) specialized training for medical technologists on diverse tissue types, and 6) upgrading the laboratory's information system to manage these functions. Thus, it appears likely that hospital administrators will come to realize that successful integration of tissue transplantation services within the facility's blood bank will require additional resources and new strategies may have to be considered. With the depth and breadth of experience and knowledge within the hospital transfusion service, we would suggest that hospital blood banks should embrace the opportunity to establish a formal centralized tissue bank as a natural extension of the services they currently provide. Given the more stringent regulatory guidelines issued by multiple health-care oversight agencies, transfusion medicine specialists and medical technologists are the most capable, skilled, and knowledgeable professionals to fulfill the standards set forth by the FDA, JCAHO, College of American Pathologists, and state and local health-care agencies. Finally, because the ultimate goal of hospitals is to deliver safe healthcare, we support the centralization of hospital tissue services within the transfusion service as an excellent way, not only to come into compliance, but also more importantly, to improve patient safety. We also welcome guidance from AABB to help its members with these evolving requirements.