The facility is licensed by the United States (US) Food and Drug Administration (FDA) 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 the Investigational New Drug (IND) program with the FDA to support Institute clinical trials. We are registered with the Center for Biologics Evaluation and Research (CBER) as a manufacturer of blood and blood products and as a manufacturer of human tissue and cellular products. Print FDA Blood Establishment Registration for DTM Main Campus. Print FDA HCT/P Establishment Registration for CCE. Print FDA Blood Establishment Registration for DTM Fishers Lane.
The laboratories providing donor testing, clinical diagnostics, and transfusion services are Clinical Laboratory Improvement Amendments (CLIA) certified by the Department of Health and Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS), formerly called the Health Care Financing Administration (HCFA). Print CLIA Certificate.
The AABB provides general accreditation of all DTM operations, including the donor center, transfusion service, hematopoietic progenitor cell activities, and immunohematology reference laboratory. Print AABB Certificate.
The Human Leukocyte Antigen (HLA) Laboratory receives accreditation from the American Society for Histocompatibility and Immunogenetics (ASHI). Print ASHI Certificate, ASHI Letter.
The Transfusion Medicine Fellowship Program is accredited by the Accreditation Council for Graduate Medical Education (ACGME). ACGME Letter
The Specialist in Blood Banking (SBB) Training Program is accredited by the Commission on Accreditation of Allied Health Education Programs (CAAHEP) in cooperation with the AABB. Print CAAHEP Certificate.