Transplant Center & Cooperative Registry Participation Criteria
Transplant Centers must meet the following criteria on an ongoing basis in order to request donors from the Gift of Life Bone Marrow Foundation. The criteria are outlined below. Centers interested in establishing participation agreements with Gift of Life must contact Barby Sloven at 1-561-982-2900. Centers that request donors through a cooperative registry that maintains a cooperative registry participation agreement with Gift of Life do not need to establish separate transplant center participation agreements, but do represent that their member transplant center(s) meet Gift of Life Standards, regulatory requirements and World Marrow Donor Association Standards.
Transplant Centers shall (1) be accredited by the Joint Commission, the American Osteopathic Association's Healthcare Facilities Accreditation Program (HFAP), or the non-US equivalent for Transplant Centers located outside the United States. Transplant Centers may also be accredited by the Foundation for the Accreditation of Cellular Therapies (FACT) or be a member transplant center of the U.S. National Marrow Donor Program, (2) have adequate physical resources to run an HPC transplant program, including, but not limited to, designated inpatient units that minimize airborne contamination; designated sites for management of search activities; and designated areas for outpatient evaluation and treatment available 24 hours per day and seven days per week, that reduces the risk of transmission of infectious agents.
Personnel and Transplant Team
Transplant Centers shall (1) ensure donors they deem to be suitably matched, are requested for recipients for whom allogeneic hematopoietic cell transplantation is a medically acceptable procedure. (2) have adequate resources to support donor search management activities, including a full time search coordinator who has a strong understanding of the search process, tissue typing methodologies, antigen specificities and HLA nomenclature; (3) have dedicated transplant medical teams, including a full time, licensed medical director with a background in allogeneic HPC transplantation and at least one other attending physician experienced in allogeneic HPC transplantation; (4) have sufficient data management personnel to comply with GOL's data submission requirements and to comply with GOL data and follow up requests in a timely manner; (5) have sufficient support personnel posessing relevant experience and qualifications; (6) have key staff readily accessible via telephone, facsimile and pager (and e-mail); (7) have a transplant team trained in the management of pediatric patients if the transplant center performs pediatric transplants; (8) obtain IRB approval of any transplant protocols for which the transplant center's IRB considers necessary; (9) be responsible for reporting adverse events to regulatory agencies as required by law and applicable accrediting agencies as required by the terms of accreditation, and to GOL in a timely manner.
Policies and Procedures / Insurance
Transplant Centers shall (1) maintain adequate written policies and procedures relating on their transplant programs and related quality assurance and improvement processes; (2) ensure that their patients for whom Gift of Life donors are requested to donate HPCs receive appropriate informed consent for their procedures and the use of the particular donors whose HPCs are intended for transplantation including any unusual donor test results or characteristics that might increase the risk of transplantation related harm to the recipient; (3) procure and maintain, at their sole expense, policies of insurance with minimum limits specified in their participation agreements with Gift of Life, insuring them against any claims, liabilities, damages and judgments that may arise as a result of carrying out their responsibilities under this Agreement.