May 12, 2009

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.

Background

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:

1. A document, Draft HRSA Specifications for Accreditation Organizations, was reviewed and edited, by the WG, with input from the accreditation organizations and the Council, and approved by Council vote in December 2008.
2. The WG reviewed all documents provided by the two organizations, including their standards and associated accreditation materials and tools, accreditation procedures and policies, and written responses to questions about their ability to meet the Draft HRSA Specifications.
3. AABB and FACT presented overviews of their accreditation programs in public session at the April 2008 Council meeting, and the Council was given the opportunity to ask detailed questions about their respective programs.
4. The WG determined that the Cord Blood Bank Standards of AABB and FACT have no incompatibilities, but acknowledged that the standards of the two organizations have some differences in format, style, and level of detail.  It was concluded that these differences do not impede the ability of both organizations to meet HRSA Specifications.  The HRSA Specifications includes a statement that HRSA may establish additional requirements for NCBI banks, and that the organizations must inspect NCBI banks against these additional requirements.
5. In March 2009, HRSA sent the final Specifications for Accreditation Organizations to AABB and FACT and requested a formal response to the Specifications.  In April 2009, both organizations indicated by formal written response that they are willing and able to meet those Specifications, including the provision that they must inspect NCBI banks against current and future HRSA requirements
6. Based on review of all materials, presentations, and statements of AABB and FACT, the Council believes that both AABB and FACT meet the HRSA Specifications, and are qualified to serve as recognized accreditation organizations for NCBI cord blood banks.