Cellular Therapy Accreditation Eligibility

Clinical Program

  • Must perform autologous and/or allogeneic transplants on adults and/or pediatric patients as appropriate for type of accreditation sought.
  • Must use products collected and processed in facilities which meet FACT-JACIE Standards.
  • If applying for allogeneic accreditation, a minimum of ten new allogeneic patients must have been transplanted during the twelve month period immediately preceding accreditation and and at a minimum, an average of ten annually within the accreditation cycle. A clinical program that is accredited for allogeneic transplantation will be considered to have met the numeric requirement for autologous transplantation.
  • A program that utilizes more than one clinical site for allogeneic transplantation must have transplanted a minimum of five new allogeneic patients at each site in the 12 months immediately preceding accreditation and at a minimum, an average of five annually within the accreditation cycle.
  • If applying for combined adult and pediatric allogeneic accreditation, the clinical program must have performed a minimum of five allogeneic transplants for each population.
  • For a clinical program requesting accreditation for only autologous transplantation, a minimum of five new recipients of autologous transplant must have been transplanted at each site during the twelve month period immediately preceding accreditation and at a minimum, an average of five annually within the accreditation cycle.
  • A dedicated transplant team including a Program Director and at least one other physician trained or experienced in hematopoietic progenitor cell therapy 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.
  • A 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, Pediatric Immunology, or Pediatric Hematology/ Oncology, and participate regularly in educational activities related to the field of HPC transplantation.
  • Must meet or exceed all current FACT-JACIE International Clinical Program Standards.

Collection Facility: Marrow or Apheresis

  • Must collect marrow cells or peripheral blood hematopoietic progenitor cell as appropriate for the accreditation being sought.
  • Must use a processing facility that meets FACT standards.
  • A collection facility, including the medical director and at least one staff member, must have been in place and performing cellular therapy product collections for at least twelve months prior to being eligible for initial accreditation.
  • For apheresis collection facilities, a minimum of ten apheresis collection procedures must have been performed in the twelve months preceding accreditation.
  • For marrow collection facilities, a minimum of one marrow collection procedure must have been performed in the twelve months preceding accreditation.
  • For renewal accreditation of apheresis collection facilities, at a minimum, an average of ten apheresis collection procedures must have been performed per year within the accreditation cycle.
  • For renewal accreditation of marrow collection facilities, at a minimum, an average of one marrow collection procedures must have been performed per year within the accreditation cycle.
  • Where required, the apheresis collection facility must be registered with the FDA or non-U.S. equivalent for the activities performed.
  • The collection facility director must have a medical degree or degree in a relevant science, qualified by postgraduate training or experience for the scope of activities carried out in the collection facility, and participates regularly in educational activities related to cellular therapy product collection and/or transplantation.
  • The collection facility medical director must be a licensed physician with postgraduate training in cell collection and/or transplantation, have at least one year of experience in cellular therapy product collection procedures, have performed or supervised at least ten such collection procedures within the last 3 years for apheresis and/or within his/her career for marrow, and participate regularly in educational activities related to cellular therapy product collection and/or transplantation.
  • 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 meet or exceed all current FACT-JACIE International Standards for Cellular Therapy Product Collection.

Processing Facility

  • Must process cellular therapy products.
  • The processing facility and staff, including a processing facility director and processing facility medical director, must have been in place and performing cellular therapy product processing for at least twelve months preceding accreditation.
  • The processing facility director must have a medical or doctoral degree in a relevant science, and be qualified by training or experience for the scope of activities carried out in the processing facility.
  • The processing facility medical director must be a licensed physician with postgraduate training and/or one year of experience in the preparation and clinical use of cellular therapy products.
  • Meet or exceed all current FACT-JACIE International Standards for Cellular Therapy Product Processing.
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Accreditation Success Story

Hoxworth Blood Center Apheresis Collection Facility and its Cellular Therapies Division have been accredited by FACT since 2003. The program values their FACT accreditation and the impact it has had on their program’s continuous quality improvement objectives. Read more