The facility is licensed by the U.S. Food and Drug Administration to manufacture red blood cells, plasma and platelets for distribution in interstate commerce. In addition to licensed manufacturing, the department provides novel cellular products under IND with the FDA to support Institute clinical trials. We are registered with CBER as a manufacturer of blood and blood products and as a manufacturer of human tissue and cellular products.

The laboratories providing donor testing, clinical diagnostics and transfusion services are CLIA certified by the DHHS Centers for Medicare & Medicaid Services (CMS), formerly called the Health Care Financing Administration (HCFA).

The American Association of Blood Banks (AABB) provides general accreditation of all DTM operations, including donor center, transfusion service, hematopoietic progenitor cell activities, and immunohematology reference laboratory.

The HLA Laboratory receives accreditation from the American Society for Histocompatibility and Immunogenetics (ASHI).

The Transfusion Medicine Fellowship Program is accredited by the Accreditation Council for Graduate Medical Education (ACGME).

The Specialist in Blood Banking Training Program is accredited by the Commission on Accreditation of Allied Health Education Programs (CAAHEP)in cooperation with the AABB.

Contact Information: call 301-496-4506, or E-mail:
nihbloodbank@mail.cc.nih.gov