Transplant Center & Cooperative Registry Participation Criteria
Transplant Centers must meet the following criteria on an ongoing basis in order to request donors and/or cord blood units 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 or cord blood units 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.
Transplant Centers shall (1) be accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), 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 by the U.S. National Marrow Donor Program; (2) have adequate physical resources to run an HPC transplant programs, 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; (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.
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; (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.
It is requested that transplant centers and cooperative registries provide and train their own couriers on proper practices and regulatory requirements of the countries in which products shall be transported. The World Marrow Donor Association promulgates standards that cover product transport requirements (“World Marrow Donor Association International Standards for Unrelated Hematopoietic Stem Cell Donor Registries”, Section 8). In addition, the article “Special report: Donor work-up and transport of bone marrow
,” provides recommendations for transport. Please visit the website of the World Marrow Donor Association for details (http://www.worldmarrow.org/
). For Gift of Life’s transport standards, contact the Associate Director at 1.561.982.2900.