FACT, Foundation for the Accreditation of Cellular Therapy, is a non-profit organization devoted to standards, accreditation, and education in cellular therapy and regenerative medicine. FACT was created by the medical community under the premise that quality cellular therapy and cord blood banking can only be achieved with cooperation among collection, processing, and clinical professionals. In 1996, FACT was formed by the International Society for Cellular Therapy (ISCT) and the American Society for Blood and Marrow Transplantation (ASBMT). Then, in 2004, FACT began to partner with Netcord, an international consortium of cord blood banks, to administer joint standards and accreditation. The voluntary inspection and accreditation process is international.
FACT currently accredits both family and public cord blood banks. In family banking, the collection site can be any clinic that delivers babies, and the collection person may be a doctor, nurse, or midwife. Some public cord blood banks have evolved to also accept mail-in donations collected by labor and delivery professionals who have completed remote training requirements. To accommodate this evolution in banking practices, the FACT Standards adopted since 2010 allow for non-fixed collection sites provided that the bank adequately trains the collectors and confirms that the shipping process protects the cord blood.
The FACT Standards and accreditation process are end-to-end, covering every aspect of cord blood handling from the moment of collection at the site where the baby is delivered, through the cord blood lab, and concluding with patient management at the clinical care site.
FACT Standards for family banks allow for a very small number of relaxed criteria that take into account differences between family and public banking circumstances. For example, family banks have 72 hours after collection to process cord blood, whereas public banks must process cord blood within 48 hours after collection. The majority of the Standards are the same for public and family banking because any successful use of cord blood depends on quality practices.
FACT-accredited cord blood banks demonstrate compliance with Standards by submitting pre-inspection documentation, undergoing a rigorous on-site inspection, and correcting deficiencies found during the inspection. Because of the emphasis on patient care, transplant physicians are included in the review of inspection results before a bank is accredited. FACT-accredited facilities are inspected every three years.
FACT accreditation is recognized as the most relevant and comprehensive cord blood bank accreditation, and the number of accredited banks continues to grow worldwide. Since 2008, the number of accredited banks has more than tripled. Currently, accredited banks represent 23 countries on five continents. The FACT website (www.factwebsite.org) includes a search engine to look up accredited banks by country.