April 10, 2009
Health Resources and Services Administration
5600 Fishers Lane
Parklawn Building, Room 12C-06
Rockville, Maryland 20857
ATTN: Mr. Remy Aronoff, ACBSCT Executive Secretary
RE: Response to HRSA specifications for accreditation of cord blood banks
Dear Advisory Council Chair and Members:
AABB appreciates the opportunity to respond to the HHS Advisory Council on Blood Stem Cell Transplantation’s (ACBSCT) request for additional information regarding AABB’s standards and accreditation programs. AABB is able and willing to meet HRSA’s current specifications and any additional requirements that HRSA may establish. Attached you will also find AABB’s response to HRSA’s specifications for accreditation of Cord Blood Banks.
AABB is a well established association that has been developing standards and assessing institutions for over 50 years. The association’s experience in the field of cellular therapies, including cord blood, spans close to two decades. AABB’s assessment and accreditation program for cellular therapies, including cord blood, is based on the AABB Standards for Cellular Therapy Product Services. In the event that HRSA should establish additional requirements for CBBs participating in the National Cord Blood Inventory program or wish to require a change in AABB’s accreditation process with respect to NCBIs, AABB can accommodate the incorporation of these requirements into the assessment and accreditation program. AABB is willing to work with HRSA to ensure that all of HRSA’s concerns are adequately addressed.
AABB is pleased to report that since our last communication with HRSA, the AABB Accreditation Program has been granted accreditation by the International Society for Quality in Health Care. AABB joins the Joint Commission International and the Accreditation Council of Canada as the only ISQua accredited programs in North America. ISQua is a non-profit, independent organization with members in more than 70 countries. ISQua works to provide services to guide health professionals, providers, researches, agencies, policy makers and consumers to achieve excellence in health care delivery to all people, and to continuously improve the quality and safety of care.
We thank you for the opportunity to provide this additional information about our organization, and its standards and accreditation programs. Your committee and HRSA play an important role in evaluating the status of cord blood therapies in the US. AABB looks forward to continued collaboration with all parties to continually improve and provide the safest possible products and services for the patients we all serve. Should you need any additional information, please feel free to contact me (email@example.com, 301.215.6501) or Jean Otter, Division Director, Standards, Accreditation and Educational Programs (firstname.lastname@example.org, 301-215-6585).
Karen Shoos Lipton, JD Jean Otter, MT(ASCP)SBB
Chief Executive Officer Division Director
Standards & Accreditation
cc: E.J. Read, MD