Note: Programs that perform transplants are accredited under the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration.
Must administer immune effector cellular therapy products to a minimum of five (5) new recipients during the twelve (12) month period immediately preceding accreditation and an average of five (5) new recipients annually within the accreditation cycle.
Must use products collected and processed in facilities which meet FACT-JACIE Standards.
Collection and processing facilities may be part of the same institution and inspected with the clinical program; contracted and inspected in relation to the clinical program; or be independently accredited as a service provider for multiple clinical programs.
FACT maintains a searchable list of accredited organizations that includes accredited services and if applicable, specific collection sites of service providers.
Must be licensed, registered, or accredited as required by appropriate governmental authority for the activities performed (e.g., FDA, Joint Commission, DNV, HFAP, non-U.S. equivalent).
Must have a designated team, including a Clinical Program Director, a quality manager, and at least one (1) other physician trained and experienced in the applicable therapeutic disease area.
A clinical program performing pediatric cellular therapy must have a team trained in the management of pediatric patients.
The clinical program director must:
Be appropriately licensed to practice medicine in the jurisdiction in which the program is located.
Be board certified (or non-U.S. equivalent) in one or more of the following specialties: Hematology, Medical Oncology, Immunology, or Pediatric Hematology/Oncology, or the applicable therapeutic disease area.
Have two (2) years of experience as an attending physician responsible for the direct clinical management of patients in the applicable therapeutic disease area in the inpatient and outpatient settings.
Participate in a minimum of ten (10) hours annually in educational activities related to cellular therapy.
Have authority over and responsibility for ensuring that the overall Quality Management Program is effectively established and maintained.
Be responsible for reviewing annual reports on the effectiveness of the Quality Management Program.
Must meet or exceed all current FACT Standards for Immune Effector Cells.
Peripheral Blood, Marrow, or Tissue Collection
Must collect a minimum of five (5) cellular therapy products, as appropriate for the accreditation being sought, in the twelve (12) months preceding accreditation, and a minimum average of five (5) cellular therapy products annually within the accreditation cycle.
Must use a processing facility that meets FACT standards.
Must be licensed, registered, or accredited as required by appropriate governmental authority for the activities performed (e.g., FDA, Joint Commission, DNV, HFAP, non-U.S. equivalent).
Cellular collection services must be overseen by a medical director, a quality manager, and at least one staff member. This team must have been in place and performing cellular therapy product collections for at least twelve (12) months prior to initial accreditation.
Medical directors of collection services must:
Be a licensed physician with postgraduate training in cellular therapy product collection or the therapeutic disease area.
Have at least one (1) year of experience in performing and/or supervising cellular therapy product collection procedures.
Participate in a minimum of ten (10) hours annually in educational activities related to cellular therapy product collection or the applicable therapeutic disease area.
Have authority over and responsibility for ensuring that the Quality Management Program is effectively established and maintained.
Be responsible for reviewing annual reports on the effectiveness of the Quality Management Program.
For collection facilities collecting cellular therapy products from pediatric donors, physicians and collection staff must have documented training and experience in performing these procedures on pediatric donors.
Must use coding and labeling technologies using ISBT 128 or Eurocode.
Must meet or exceed all current FACT Standards for Immune Effector Cells.
Processing
Must process cellular therapy products.
A processing facility, including a processing facility director, a processing facility medical director, a quality manager, and at least one (1) staff member, must have been in place and performing cellular therapy product processing for at least twelve (12) months prior to initial accreditation.
Must be licensed, registered, or accredited as required by the appropriate governmental authority for the activities performed (e.g., FDA or non-U.S. equivalent).
The processing facility director must:
Have a medical degree, doctoral degree, or equivalent degree in a relevant science.
Be qualified by two years of training and experience for the scope of activities conducted in the processing facility.
Participate in a minimum of ten (10) hours annually in educational activities related to cellular therapy product processing or the applicable therapeutic disease area.
Have authority over and responsibility for ensuring that the Quality Management Program is effectively established and maintained.
Be responsible for reviewing annual reports on the effectiveness of the Quality Management Program.
The processing facility medical director must:
Be a licensed physician.
Have a minimum of two years postgraduate training and practical and relevant experience for the scope of activities carried out in the preparation and clinical use of cellular therapy products.
Participate in a minimum of ten (10) hours annually in educational activities related to cellular therapy product processing or the applicable therapeutic disease area.
Must use coding and labeling technologies using ISBT 128 or Eurocode.
Must meet or exceed all current FACT Standards for Immune Effector Cells.
Organizations that conduct business in a language other than English must translate a minimal set of documents into English prior to the on-site inspection. Refer to the Document Submission Requirements form for Immune Effector Cells.
