FACT Accreditation
Eligibility Requirements

Perform at least the following number of transplants for new recipients during the 12 months prior to initial accreditation (application may start earlier) and annually thereafter:

• Allogeneic: minimum of 10 new allogeneic patients

  • For multiple clinical sites, minimum of 3 new allogeneic patients at each site

• Autologous only: minimum of 5 new autologous patients at each site

• For a combined adult and pediatric program, minimum of 5 new patients for each population

• Programs may begin the accreditation application process while actively working to achieve
these minimum numbers. A new program may also be eligible for provisional accreditation

If immune effector cells (IECs) are administered (not required), administer IEC products to at least the following number of new recipients during 12 months prior to initial accreditation (application may start earlier) and annually thereafter:

• Minimum of 5 new recipients at each site

• For a combined adult and pediatric program, minimum of 6 new recipients with at least one in each population

  • For multiple clinical sites, minimum of 3 recipients at each site

Use products collected and processed in facilities that meet FACT-JACIE Standards

Have a team that includes a Clinical Program Director, a Quality Manager, and at least one other physician trained or experienced in hematopoietic progenitor cell therapy. If treating pediatric patients, includes team trained and board certified/eligible for this population

Hold all licenses, registrations, and accreditations as required by appropriate governmental authority for the activities performed (eg, FDA, Joint Commission, DNV, HFAP, non-US equivalent)

Compare 1-year survival outcome to national or international outcome data. Refer to the Clinical Outcomes Resource Center for additional information

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

Comply with all current FACT-JACIE HCT Clinical Program Standards

Licensed to practice medicine in the program’s jurisdiction

Minimum 2 years as attending physician managing HPC transplant patients

Board certified (or equivalent) in Hematology, Medical Oncology, Immunology, or Pediatric Hematology/Oncology

Completes at least 10 hours of continuing education annually in HPC transplantation or cellular therapy

Oversees the Quality Management Program and reviews its effectiveness each year

Perform at least the number of collection procedures for each type during the 12 months prior to initial accreditation (application may start earlier) and annually thereafter:

• Marrow: 1 collection prior to initial accreditation; maintain an annual average of 1 collection thereafter

• Apheresis: 10 collections prior to initial accreditation; maintain an annual average of 10 collections thereafter

• Other tissues: 1 collection prior to initial accreditation; maintain an annual average of 1 collection thereafter

Use a processing facility that meets FACT Standards

Hold all required licenses, registrations, or accreditations

Maintain a Director, Medical Director, Quality Manager, and at least one staff member performing collections for at least 12 months before accreditation (application may begin earlier)

Implement ISBT 128 or Eurocode coding and labeling systems

Comply with current FACT-JACIE Collection Facility Standards

Holds a relevant science degree and ≥2 years’ management experience

Completes ≥10 hours of continuing education annually in HPC transplantation, cellular therapy, or quality management

Oversees and annually reviews the Quality Management Program

Licensed physician with ≥2 years’ postgraduate training and experience in cell collection/transplantation

Performs or supervises required procedures:

Marrow: 10 lifetime and ≥1 per year per accreditation cycle

Apheresis: ≥5 in the prior 12 months and annually thereafter

Other tissues: at least one tissue collection procedure

Completes ≥10 hours of continuing education annually in cellular therapy, transplantation, or quality management

For pediatric donors, ensures all physicians and staff are trained and experienced in pediatric procedures

Conduct cellular therapy product processing under required licenses or registrations (eg, FDA or equivalent)

Hold all required licenses, registrations, or accreditations

Maintain a Director, Medical Director, Quality Manager, and at least one staff member performing processing for >12 months before accreditation (application may begin earlier)

Implement ISBT 128 or Eurocode coding and labeling systems

Comply with current FACT-JACIE Processing Standards

Holds a medical/doctoral degree with ≥2 years’ experience, or an advanced degree with ≥10 years’ relevant experience in cellular therapy management

Performs or supervises ≥5 processing procedures in the prior 12 months and annually thereafter

Completes ≥10 hours of continuing education annually in HPC transplantation, cellular therapy, or quality management

Oversees and reviews the Quality Management Program annually

Licensed physician with ≥2 years’ postdoctoral training and experience in cellular therapy product preparation and use

Performs or supervises ≥5 processing procedures in the prior 12 months and annually thereafter

Completes ≥10 hours of continuing education annually in HPC transplantation or cellular therapy

Administer IEC products to at least the following number of new recipients during 12 months prior to initial accreditation (application may start earlier) and annually thereafter:

• Minimum of 5 new recipients at each site

• For a combined adult and pediatric program, minimum of 6 new recipients with at least one in
each population

  • For multiple clinical sites, minimum of 5 recipients at each site

• Programs may begin the accreditation application process while actively working to achieve
these minimum numbers. A new program may also be eligible for provisional accreditation

Use products collected and processed in facilities that meet FACT-JACIE Standards

Have a team that includes a Clinical Program Director, a Quality Manager, and at least one other physician trained or experienced in cellular therapy or the applicable therapeutic disease area. If treating pediatric patients, includes team trained and board certified/eligible for this population

Hold all licenses, registrations, and accreditations as required by appropriate governmental authority for the activities performed (eg, FDA, Joint Commission, DNV, HFAP, non-US equivalent)

Comply with all current FACT-JACIE IEC Clinical Program Standards or current FACT Community IEC Clinical Program Standards as applicable

Licensed to practice medicine in the program's jurisdiction

Board certified (or equivalent) in Hematology, Medical Oncology, Immunology, Pediatric Hematology/Oncology, or the relevant therapeutic area

Minimum 2 years as attending physician managing patients in the therapeutic area

Complete at least 10 hours of continuing education annually in cellular therapy

Oversees the Quality Management Program and reviews its effectiveness each year

Perform at least the number of collection procedures for each type during the 12 months prior to initial accreditation (application may start earlier) and annually thereafter:

• Marrow: 1 collection prior to initial accreditation; maintain an annual average of 1 collection thereafter

• Apheresis: 10 collections prior to initial accreditation; maintain an annual average of 10 collections thereafter

• Other tissues: 1 collection prior to initial accreditation; maintain an annual average of 1 collection thereafter

Use a processing facility that meets FACT-JACIE IEC Standards

Hold all required licenses, registrations, or accreditations

Maintain a Director, Medical Director, Quality Manager, and at least one staff member performing collections for at least 12 months before accreditation (application may begin earlier)

Comply with current FACT-JACIE IEC Facility Standards

Holds a relevant science degree and ≥2 years management experience

Completes ≥10 hours of continuing education annually in HPC transplantation, cellular therapy, or quality management

Oversees and annually reviews the Quality Management Program

Licensed physician with ≥2 years' postgraduate training and experience in cell collection

Performs or supervises required procedures based on expertise:

• Marrow: 10 lifetime and ≥1 per year per accreditation cycle

• Apheresis: ≥5 in the prior 12 months and annually thereafter

• Other tissues: at least one tissue collection procedure

Completes ≥10 hours of continuing education annually in cellular therapy, transplantation, quality management, or cell collection

For pediatric donors, ensures all physicians and staff are trained and experienced in pediatric procedures

Conduct cellular therapy product processing under required licenses or registrations (eg, FDA or equivalent)

Maintain a Director, Medical Director, Quality Manager, and at least one staff member performing processing for ≥12 months before accreditation (application may begin earlier)

Complies with current FACT-JACIE Processing Standards

Holds a medical/doctoral degree with ≥2 years' experience, or an advanced degree with ≥10 years relevant experience in cellular therapy management

Performs or supervises ≥5 processing procedures in the prior 12 months and annually thereafter

Completes ≥10 hours of continuing education annually in HPC transplantation, cellular therapy, or quality management

Oversees and reviews the Quality Management Program annually

Licensed physician with ≥2 years' postdoctoral training and experience in cellular therapy product preparation and use

Performs or supervises ≥5 processing procedures in the prior 12 months and annually thereafter

Completes ≥10 hours of continuing education annually in cellular therapy product processing or the applicable therapeutic disease area

Doctoral degree in medicine or related scientific field, or post-baccalaureate degree in a relevant science with ≥5 years’ experience in CB processing activities

Training and ≥2 years’ experience in one or more of the following: immunogenetics of transplantation, basic or clinical immunology, immunohematology, basic or clinical hematology, transfusion medicine, blood or tissue banking, or cryobiology

Current medical license

Training in hematopoietic cell transplantation or blood/tissue banking