FACT Standards Available for Public Review and Comment

FACT-JACIE International Standards

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) published the draft Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment. These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, or cord blood.

Description and Instructions for Review and Comment

Summary of Changes

Draft Eighth Edition FACT-JACIE International Standards

Comments regarding the draft Eighth Edition FACT-JACIE International Standards can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.


FACT Standards for Immune Effector Cells

The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Second Edition FACT Standardsfor Immune Effector Cells for inspection and public comment. These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes, but is not limited to, genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

Description and Instructions for Review and Comment

Summary of Changes

Draft Second Edition FACT Standards for Immune Effector Cells

Comments regarding the draft Second Edition FACT Standards for Immune Effector Cells can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.


Ongoing Feedback on Current Standards

Comments from the public regarding the current Standards and/or Accreditation Manuals may be submitted at any time. Intermittently, it is necessary update the Standards or Accreditation Manuals based on changes to applicable laws and regulations, field experience, or other reasons. FACT has a process to accommodate needed changes between editions which can be found in the Establishing and Reviewing Standards policy.

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Accreditation Success Story

Quality is The Standard at M.D. Anderson Cancer Center. M. D. Anderson Cancer Center is recognized as No. 1 in cancer care in U.S. News & World Report's annual "America's Best Hospitals" survey, in part due to our FACT accreditation. Read more