As of July 21, 2004, all cord blood banks are required to register with the Food and Drug Administration (FDA). In addition to requiring registration, the FDA sets standards for testing the cord blood and provides surprise inspections to ensure proper practices are being upheld.
What Does Accreditation Mean?
Private cord blood banks also get additional accreditation. It is important to note that the processing techniques and technology is not regulated and they vary greatly between banks. Instead, accreditation is more like quality assurance. For example, they may evaluate if the banks have procedures in place and if they are followed. Or if they accurately record data and if those records are safely maintained. Not all cord blood banks are accredited. Review our list of banks to find out which banks are accredited by AABB or FACT.
United States Accrediting Agencies
The two main accrediting agencies for private cord blood banks in the United States are AABB and FACT. As of today, most accredited private cord banks are AABB accredited, but this is because private banks were not available for FACT accreditation until 2009. Below is a brief introduction to the industry leading accreditation and licensing agencies for cord blood labs.
The AABB, which is formerly known as the American Association of Blood Banks, is an international association representing individuals and institutions involved in activities related to transfusion and cellular therapies, including transportation medicine.
- Offers various types of accreditation, including cord blood
- Facilities are inspected every 2 years
- Enforces tests for medical history, mothers blood, and cord blood
Foundation for the Accreditation of Cellular Therapy (FACT) establishes standards for high quality medical and laboratory practice in cellular therapies.
- Began by accrediting only public cord blood banks
- In 2009 began accrediting private cord blood banks
- Inspects process all the way from collection site to clinical patient management