Maintaining Accreditation

Cellular Therapy programs and affiliated facilities must:

• Meet or exceed all current FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration.
• Maintain registration with the FDA or non-U.S. equivalent for the activities performed, as appropriate.
• Report significant changes in the program to the FACT office within 90 days of occurrence, including:
  • Physical move of all or part of the program to a new building or to a building that has not been inspected by FACT.
  • Reorganization of previously inspected physical space or annexation of additional contiguous space.
  • Expansion of services offered, including but not limited to:
    • Addition of allogeneic transplant to an autologous program.
    • Addition of adult transplant to a pediatric program or pediatric transplant to an adult program.
    • Addition of new or additional clinical, collection, or processing services.
  • Change of program name.
  • Change in the program director or other facility director.
  • Changes in ownership or mergers between accredited organizations.
  • Changes to the organization as directed by applicable governmental agencies.
  • Changes due to a natural disaster.
• Complete and submit the FACT interim accreditation report provided by the FACT office.
• Submit any documents that were requested by the FACT Accreditation Committee to be submitted at the time of the interim report.
• Meet the following additional requirements for Clinical Programs and Collection Facilities:

Clinical Program

• For allogeneic accreditation, perform allogeneic transplants for at least ten new patients annually. (A clinical program that is accredited for allogeneic transplantation will be considered to have met the numeric requirement for autologous transplantation.)
• For autologous accreditation only, perform autologous transplants for at least five new patients annually.
• For programs utilizing more than one clinical site and/or performing adult and pediatric transplantation, perform allogeneic transplants (autologous transplants if accredited for autologous only) for at least five new allogeneic patients at each site and of each population annually.
• Must use products from collection and processing facilities that meet FACT-JACIE Standards.

Collection Marrow or Apheresis

• Apheresis collection facilities must collect at least 30 products by apheresis within an accreditation cycle.
• Bone marrow collection facilities must perform at least three bone marrow collection procedures within an accreditation cycle.
• Use a facility that meets FACT-JACIE Standards for cell processing.

Cord Blood Bank

• Be actively banking.
• Meet or exceed all current NetCord-FACT International Standards.
• Report significant changes in key personnel, facilities, and/or services to the FACT office within 90 days of the occurrence, including:
  • Change in bank or facility director.
  • Physical move of all or part of a bank to a new facility that has not been inspected by FACT
  • Addition of services, such as addition of private banking if accredited for public banking, or addition of collections performed at non-fixed sites when accredited only for collections at fixed sites.
  • Changes in contractual service providers.
  • Changes due to natural disasters.
  • Expansion of services, including addition of collection sites.
• Complete and submit the FACT interim accreditation report provided by the FACT office.
• Submit any documents that were requested by the FACT Accreditation Committee to be submitted at the time of the interim report.