About FACT

 

Founded in 1996, 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.  The major objective of FACT is to promote high quality patient care and laboratory performance in the belief that a valid accreditation must assess both clinical and laboratory aspects.

In 2000, recognizing the global impact of cord blood banking and transplantation, FACT partnered with NetCord to develop international standards for cord blood collection, processing, testing, banking, selection and release. The NetCord foundation is an international network of non-profit public cord blood banks created to promote the establishment of high quality cord blood banks and improve the quality of cord blood products through study and research.

In 2006, FACT, in collaboration with the Joint Accreditation Committee–ISCT & EBMT (JACIE), developed international standards in the field of cellular therapy.  JACIE was founded by the European Group for Blood and Marrow Transplantation (EBMT) and the International Society for Cellular Therapy (ISCT), the two leading scientific organizations involved with cellular transplantation in Europe.

FACT accredits facilities under the two sets of international standards developed in cooperation with JACIE and NetCord:

FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration. These Standards apply to hematopoietic progenitor cells isolated from bone marrow or peripheral blood and to all phases of collection, processing, and administration of these cells.

NetCord-FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release. These Standards apply to facilities and individuals performing cord blood collection, processing, testing, banking, selection and release of cord blood units. 

These standards were developed by international teams of experts in the field of cellular therapy and cord blood banking. The standards contain the minimum guidelines for facilities and individuals performing cellular therapy product transplantation, cord blood banking, or providing support services for such activities. 

Accreditation is awarded after successful documentation of compliance with the current standards.  Compliance is determined by evaluation of written documents provided by the facility and by on-site inspection.  On-site inspections are carried out by a team of inspectors who are qualified by training and experience, have attended inspector training and who have a working knowledge of FACT-JACIE Cellular Therapy Product Standards or NetCord-FACT Cord Blood Banking Standards, as appropriate, and of their application to various aspects of the facilities being inspected.  The inspection process is quality-oriented and follows the FDA’s rules for current Good Tissue Practice (cGTP).