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/.

Updated Donor History Questionnaires Now Available

Posted in :: 2017 Volume 1 :: Thursday, January 26th, 2017

The interorganizational Donor History Questionnaire materials have been updated to reflect recommendations made by the FDA’s Guidance for Industry: “Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates,” published in November 2016.

The Donor History Questionnaire (DHQ) materials were developed to screen allogeneic HPC donors for communicable disease risk factors in accordance with requirements of the Food and Drug Administration (FDA), AABB, FACT, and the National Marrow Donor Program (NMDP).

The FDA does not mandate use of any particular tool to fulfill donor screening requirements for communicable disease risks and has determined that “official” recognition of DHQ materials in a guidance document is not warranted. The task force believes the DHQ materials, which are harmonized with applicable regulations and guidance documents, will optimize donor comprehension of the questions and provide donor historians with the tools needed to evaluate donor responses. Facilities should read the “User Instructions” carefully before adopting the materials for use.

When a facility implements a new version of these DHQ materials, it should follow its established change control process for the incorporation of the new DHQ materials. The change control process should address validation of the use of the new version with other existing processes and appropriate staff training.

View chart detailing changes

Donor History Questionnaire for Allogeneic HPC, Apheresis and HPC, Marrow – Version 1.6 December 2016

Donor History Questionnaire for HPC, Cord Blood DHQ Version 1.3, December 2016