FAQ

Maintaining Accreditation

The Cellular Therapy Transplant Program and Associated or Independent Facilities:

• Meet or exceed all current FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration.
  FACT current standards page for download or purchase
• Maintain registration with the FDA or non-U.S. equivalent for the activities performed, as appropriate.
• Changes in key personnel, facilities, and/or services must be reported to the FACT office for verification of the appropriateness in regards to meeting FACT standards.
• Complete and submit the FACT interim accreditation report provided by the FACT office.
• At the time of submission of the interim report submit any documents that were requested by the FACT Accreditation Committee to be submitted at the time of the interim report.
• Submit renewal documents at least 6 months prior to expiration date and adhere to the renewal timeline.

 Clinical Program

• Perform autologous and/or allogeneic transplants on adults and/or pediatric patients as appropriate for type of accreditation awarded.
• For allogeneic accreditation, at least 10 new recipients of allogeneic transplant must be transplanted annually. A clinical program that is accredited for allogeneic transplantation will be considered to have met the numeric requirement for autologous transplantation.
• For programs utilizing more than one clinical site and/or performing adult and pediatric transplantations at least 5 new allogeneic patients at each site and of each population must be performed annually, as appropriate for the accreditation granted.
• For autologous accreditation only, at least 5 new recipients of autologous transplant must be transplanted annually.
• Must use products from collection and processing facilities which meet FACT-JACIE standards.

Collection Facility: Bone Marrow or Apheresis

• Collect bone marrow cells or peripheral blood hematopoietic progenitor cell as appropriate for the accreditation granted.
• Cellular therapy products must be processed by a facility that meets FACT standards.

 Processing Facility

• Process cellular therapy products.