Accreditation Statistics

As of May 2, 2024

Cellular Therapy Entities

  • Accredited: 262
  • Applicants: 30

Cord Blood Banks

  • Accredited: 48
  • Applicants: 10

 

Initial Accreditations

  • Abu Dhabi Stem Cell Center, Abu Dhabi, United Arab Emirates | Cellular Therapy Product Processing with Minimal Manipulation
  • CHN - Complexo Hospitalar de Niterói, Rio de Janeiro, Brazil | Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Marrow and  Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation

     

A complete list of accredited organizations can be found at https://accredited.factglobal.org/.

Responding to Inspection Citations is an Opportunity to Improve

Posted in :: 2023 Volume 2 :: Thursday, April 27th, 2023

The FACT Accreditation Committee reviews each inspection report and determines the outcome and required response from the accreditation applicant. A letter explaining the committee’s findings with instructions for documenting corrections, and the report listing the deficiencies and required responses, is sent to the organization following this determination. Each citation requires submission of the complete required response in the accreditation portal through the Request For Information (RFI).

Complete responses must include:

  • Explanation of correction.
  • Evidence of implementation.
  • Supporting Standard Operating Procedures (SOPs) with changes highlighted.
  • SOP approval documentation (signatures and date).
  • Training documentation.
  • Other identified documentation.

Each identified issue is an opportunity for improvement. The response must include an explanation of the correction and demonstrate how the applicable standard is met. Keep in mind that the reviewer of the submission will be less familiar than you with your organization’s operations or document control system. Walk the reviewer through each step in your process and identify where to find the supporting information in the submitted documents (e.g., list the page number and section or highlight the information). Ensure responses do not include Protected Health Information (PHI).

If you feel your process is sufficient or was misinterpreted during the inspection, explain your process, and submit supporting documentation demonstrating that it was in place during the time of the inspection.

Complete submissions must include a thorough explanation of correction and clearly marked supporting documentation to expedite review. The Applicant Response Template includes response examples. Once all citations have been adequately addressed, accreditation will be awarded.