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Transplant Center Criteria

Criteria

Transplant Centers must meet the following criteria, outlined below, on an ongoing basis in order to request donors from the Gift of Life Marrow Registry. 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 participation agreement with Gift of Life do not need to establish separate transplant center participation agreements. They represent that their member transplant center meets Gift of Life Standards, regulatory requirements, and World Marrow Donor Association Standards

Facility Characteristics

Transplant Centers shall:

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.
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—to reduce the risk of transmission of infectious agents.

Personnel and Transplant Team

Transplant Centers shall:

  • Ensure donors they deem to be suitably matched are requested for recipients for whom allogeneic hematopoietic cell transplantation is a medically acceptable procedure.
  • 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.
  • 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.
  • 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.
  • Have sufficient support personnel possessing relevant experience and qualifications.
  • Have key staff readily accessible via telephone, facsimile pager, and e-mail.
  • Have a transplant team trained in the management of pediatric patients if the transplant center performs pediatric transplants.
  • Obtain IRB approval of any transplant protocols the transplant center's IRB considers necessary.
  • Be responsible for reporting adverse events to regulatory agencies as required by law, applicable accrediting agencies as required by the terms of accreditation, and to GOL in a timely manner.

 Policies and Procedures/Insurance

Transplant Centers shall:

Maintain adequate written policies and procedures relating to their transplant programs and quality assurance and improvement processes.

Ensure that their patients for whom Gift of Life donors are requested to donate HPCs give appropriate informed consent for their procedures and for the use of the particular donor(s) 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.

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.
 

Transport Policy

Transplant Centers and Cooperative Registries are requested to provide and train their own couriers on proper practices and regulatory requirements for the domestic and international transportation of HPC products according to the World Marrow Donor Association’s Transport Guidelines. Click here for full details.