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Updated Versions of FACT-JACIE Hematopoietic Cellular Therapy Standards and Accreditation Manual Available

JACIE Committee
Inspector Committee
Accreditation Committee
Quality Managers Committee

The Eighth Edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration has been updated to Version 8.1, and its accompanying Hematopoietic Cellular Therapy Accreditation Manual has been updated to Version 8.2.

Version 8.1 of the Standards becomes effective on January 14, 2022.  The changes from Version 8.0 to 8.1 are clerical in nature, and organizations accredited under these Standards should already be in compliance. Most of the changes in the Accreditation Manual from Version 8.1 to 8.2 are also clerical.  Substantive content changes to the manual reaffirm and clarify donor screening and donor lymphocyte infusion (DLI) eligibility requirements.  Reference Appendix V in both documents for a summary of the changes.

The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.

The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.