Founded in 1996, FACT establishes standards and administers a voluntary accreditation for high quality medical and laboratory practice in cellular therapies. FACT is a non-profit corporation co-founded by the International Society for Cellular Therapy (ISCT) and the American Society of Blood and Marrow Transplantation (ASBMT) for the purposes of voluntary inspection and accreditation in the field of cellular therapy.
FACT Standards are evidence-based requirements set by world-renowned experts vested in the improvement and progress of cellular therapy. They are developed by consensus within committees consisting of knowledgeable clinicians, scientists, technologists, and quality experts who represent the entire continuum of cellular therapy product manufacturing and administration. With unparalleled depth and breadth, the Standards trace the entire life of a cell product from donor selection to collection, processing, storage, release, and ultimately administration to a patient. FACT publishes three sets of Standards:
- FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration
- NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration
- FACT Common Standards for Cellular Therapies
The voluntary FACT accreditation program is founded upon a network of peers helping each other improve cellular therapy practices. Rigorous and comprehensive inspections are balanced with a collegial approach that encourages organizations to achieve a required level of quality for the benefit of patients. Inspectors are volunteers who are international experts in their field with current and practical knowledge of the intent of the requirements. Multiple levels of review and oversight ensure accreditation is awarded consistently, thoroughly, and objectively based upon the international standards. Organizations that achieve FACT accreditation have developed and implemented a foundation of high-quality practices that result in cell products and patient care that are sought after by physicians and patients.