Must perform autologous and/or allogeneic transplants on adults and/or pediatric patients as appropriate for type of accreditation sought.
May or may not administer immune effector cellular therapy products. There is no minimum number of products administered required when accredited for transplant.
Must use products collected and processed in facilities that 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 transplant at least the following number of new recipients during the twelve months prior to initial accreditation and annually thereafter:
If seeking allogeneic* accreditation at a single clinical site, a minimum of ten (10) new allogeneic patients.
If seeking allogeneic* accreditation at multiple clinical sites, a minimum of five (5) new allogeneic patients at each site.
If seeking allogeneic* accreditation for a combined adult and pediatric program, a minimum of five new allogeneic patients for each population.
If seeking autologous only accreditation, a minimum of five new autologous patients. *A clinical program that is accredited for allogeneic transplantation will be considered to have met the numeric requirement for autologous transplantation.
Must have a dedicated transplant team, including a Clinical Program Director, a quality manager, and at least one other physician trained or experienced in hematopoietic progenitor cell therapy. The designated team must be in place for at least twelve months preceding accreditation.
A clinical program performing pediatric transplantation must have a transplant team trained in the management of pediatric patients, and at least one attending physician who is board certified/eligible (or non-U.S. equivalent) in Pediatric Hematology/Oncology or Pediatric Immunology.
The clinical program director must:
Be appropriately licensed to practice medicine in the jurisdiction in which the program is located.
Have a minimum of two (2) years of experience as an attending physician responsible for the direct clinical management of HPC transplant patients throughout the continuum of care.
Be board certified (or non-U.S. equivalent) in one or more of the following specialties: Hematology, Medical Oncology, Immunology, or Pediatric Hematology/ Oncology.
Participate in a minimum of ten (10) hours annually in educational activities related to the field of HPC transplantation and other cellular therapies.
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 compare one-year survival outcome to national or international outcome data. Refer to the Clinical Outcomes Resource Center for additional information.
Must collect, maintain, and submit data in the Transplant Essential Data Forms of the CIBMTR or the Minimum Essential Data-A forms of the EBMT to a national or international database. Refer to the Data Management Resource Center for additional information.
Must meet or exceed all current FACT-JACIE International Clinical Program Standards.
Marrow or Peripheral Blood Collection
Must collect marrow cells or peripheral blood hematopoietic progenitor cells as appropriate for the accreditation being sought.
For marrow collection facilities, a minimum of one (1) marrow collection procedure must have been performed in the twelve (12) months preceding accreditation and a minimum average of one (1) marrow collection annually thereafter.
For apheresis collection facilities, a minimum of ten (10) apheresis collection procedures must have been performed in the twelve months preceding accreditation, and annually thereafter.
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. Refer to B1.3.1 in the HCT Accreditation Manual.
A collection facility, including the collection facility director, medical director, quality manager, and at least one staff member, must have been in place and performing cellular therapy product collections for at least twelve months prior to initial accreditation.
The apheresis collection facility director must:
Must have a medical degree or degree in a relevant science with two (2) years of postgraduate training and experience in cellular therapy product collection procedures at a minimum.
Must have two (2) years of postgraduate training and experience for the scope of activities conducted in the collection facility.
Must have performed or supervised a minimum of five (5) cellular therapy product apheresis collection procedures in the twelve (12) months preceding accreditation and annually thereafter.
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 Quality Management Program is effectively established and maintained.
Be responsible for reviewing annual reports on the effectiveness of the Quality Management Program.
The collection facility medical director must:
Be a licensed physician.
Have at least two (2) years postgraduate training and experience in cell collection and transplantation.
Have performed or supervised the minimum number of collection procedures.
For marrow, the collection facility medical director must have performed or supervised ten (10) marrow collection procedures within their career.
For apheresis, the collection facility medical director must have performed or supervised a minimum of five (5) cellular therapy product apheresis collection procedures in the twelve (12) months preceding accreditation and annually thereafter.
Participate in a minimum of ten (10) hours annually in educational activities related to cellular therapy.
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-JACIE International Standards for Cellular Therapy Product Collection.
Processing
Must process cellular therapy products.
The processing facility and staff, including a processing facility director, a processing facility medical director, a quality manager, and at least one staff member, must have been in place and performing cellular therapy product processing for at least twelve 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 or doctoral degree in a relevant science.
Be qualified by a minimum of two (2) years training and experience for the scope of activities conducted in the Processing Facility.
Performed or supervised a minimum of five (5) cellular therapy product processing procedures in the 12 months prior to initial accreditation and annually thereafter.
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 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 (2) years combined postdoctoral training and practical relevant experience in the preparation and clinical use of cellular therapy products.
Performed or supervised a minimum of five (5) cellular therapy product processing procedures in the 12 months prior to initial accreditation and annually thereafter.
Participate in a minimum of ten (10) hours annually in educational activities related to cellular therapy.
Must use coding and labeling technologies using ISBT 128 or Eurocode.
Meet or exceed all current FACT-JACIE International Standards for Cellular Therapy Product Processing.
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 Hematopoietic Cellular Therapy.
