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The  Foundation for the Accreditation of Cellular Therapy (FACT)  establishes standards 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, including bone marrow transplantation, cord blood banking, regenerative medicine, and immune effector cell therapy. The mission of FACT is to improve the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients.

The core of FACT is its active Board of Directors, comprised of an equal number of representatives from ISCT and ASBMT, the Presidents-elect of these two parent organizations, the FACT Medical Director, and the Chairperson of the Standards Committee, who represents ASBMT, ISCT, or both. Standing committees of the Board oversee the activities of the Foundation.

FACT Inspectors perform on-site inspections of cellular therapy programs who are seeking accreditation or re-accreditation, including clinical programs, cellular collection facilities, and cell processing laboratories and facilities. FACT Inspectors are active participants in the field of cellular therapy and are experts with the most current knowledge of the field. Many are those providing cellular therapy services to patients or are the researchers and innovators who are responsible for advancing cellular therapies. FACT Inspectors volunteer their time to review program compliance with FACT Standards and to travel to perform on-site inspections. FACT does not use paid inspectors or FACT employees as inspectors. FACT Inspectors are are required to be employed at a program that is either FACT accredited or is an active applicant for FACT Accreditation.

Incorporation
FACT was founded in 1995 to promote quality patient care and laboratory practice in hematopoietic cell transplantation through its program of professional standards and voluntary accreditation for the procurement, processing, and transplantation of hematopoietic cell products. FACT was formally known as “FAHCT” (The Foundation for the Accreditation of Hematopoietic Cellular Therapy) until it expanded operations into other cellular therapies beyond hematopoietic cells.

FACT is the accreditation arm of two professional societies dedicated to improvement and progess in cellular therapy: the American Society of Blood and Marrow Transplantation (ASBMT) and the International Society of Cellular Therapy (ISCT). ISCT is a global association driving the translation of scientific research to deliver innovative cellular therapies to patients. Since 1992, ISCT has been the leading global forum for developing and supporting innovative cellular therapies through communication, education and training. ASBMT is an international professional association that promotes the advancement of the blood and marrow transplantation field. ASBMT members are both in clinical practice and in research.

Believing that quality care can only be achieved if both clinical and laboratory issues are effectively addressed, these two organizations merged their standards into a single document covering all aspects of hematopoietic cell therapy (collection, processing, and transplantation), which formed the foundation for the first edition of FACT Standards. The two societies established FACT in order to develop a voluntary inspection and accreditation program based on the joint Standards.

Recognizing the importance of developing consensus Graft Processing Standards, in 1994 the North American Task Force (NATF) was formed consisting of all the major professional organizations interested in hematopoietic cell therapy, including ISCT, ASBMT, and FACT. There was general consensus that the FACT Standards were of sufficiently high quality to serve as a template for the other organizations involved in this field.

The FACT inspection and accreditation program was developed by Dr. Phyllis Warkentin, FACT Medical Director, in conjunction with the FACT Board of Directors and the ISCT and ASBMT regulatory and standards committees.

International Expansion
Cellular transplantation is an international effort. Because the best donor for an unrelated donor transplant is often in a country other than that of the recipient, international standards for cellular therapy products are important in facilitation of these transplants. To address this issue, FACT representatives worked with colleagues from the European Group for Blood and Marrow Transplantation (EBMT) and ISCT-Europe to establish the Joint Accreditation Committee of ISCT-Europe and EBMT (JACIE). The primary aim of JACIE is to improve the quality of hematopoietic cell transplantation in Europe through its accreditation and education programs, and to work toward international harmonization of standards and regulations. JACIE adopted the first edition of FACT Standards in 1999. The second edition of the Cellular Therapy Standards was jointly reviewed by FACT and JACIE, with the third and fourth editions jointly developed by the two organizations.

The first edition of FACT Standards for Hematopoietic Progenitor Cell Collection, Processing and Transplantation (1996) did include a few general standards related specifically to the collection of cord blood. However, it became apparent that the field of placental and umbilical cord blood banking is more complex than addressed in the first edition. Representatives of FACT, ISCT, and ASBMT collaborated with members of NetCord, an international network of independent cord blood banks, to draft comprehensive international standards for cord blood and to establish an accreditation program parallel to the FACT accreditation program for cellular therapy.

The Standards have also been adopted as the official standards for HPC by the Canadian and Australian governments.