The ACBSCT met on May 12, 2009, in Bethesda, Maryland, and unanimously agreed on its fifth consensus recommendation.
ACBSCT recommends the Secretary recognize both the American Association of Blood Banks (AABB) and the Foundation for the Accreditation of Cellular Therapy (FACT) as Accreditation Organizations for the National Cord Blood Inventory (NCBI). Both organizations are expected to adhere to the Health Resources and Services Administration’s (HRSA) Specifications for Accreditation Organizations, and their continued recognition is based on ongoing adherence to HRSA Specifications. ACBSCT will review, three years from the time of the recognition decision by the Secretary, HRSA’s experience with the Accreditation Organizations with regard to meeting the HRSA Specifications.
Public Law 109-129 (The Stem Cell Therapeutic and Research Act) provides for the National Cord Blood Inventory (NCBI), a federally funded program for the collection and maintenance of cord blood units, and authorizes the C.W. Bill Young Cell Transplantation Program. The Act mandates that “the Secretary shall, through a public process, recognize one or more accreditation entities for the accreditation of cord blood banks.” The Act further requires that NCBI banks must be accredited by the organization(s) so recognized.
Prior to formation of the ACBSCT, the Health Resources and Services Administration (HRSA) gave interim recognition to AABB and FACT for initial NCBI competitions. Therefore, all NCBI banks are currently accredited by AABB or FACT, or both. This interim decision was to be followed by a recognition process that allowed for input by the Advisory Council and the public. AABB and FACT are the only organizations accrediting cord blood banks in the United States.
In January 2008, HRSA charged the Advisory Council to formulate a plan for developing recommendations with regard to accreditation to the Secretary, and formed an Accreditation Work Group. Over the past year, this Work Group (WG) has facilitated a series of steps to support an informed decision on recognition: