Kara Wacker, Strategic Planning Administrator
Foundation for the Accreditation of Cellular Therapy
Omaha, NE USA
The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) have published for public comments drafts of both the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Ninth Edition (HCT 9 Standards) and the FACT-JACIE International Standards for Immune Effector Cells, Third Edition (IEC). These documents are now open for public comments which will be accepted through December 15, 2024.
We encourage you to review these draft Standards and to submit your comments and recommendations. This is an important way to make your opinions known to the Standards Committee. Each comment will be reviewed, and the results of the Standards Committee discussion will be published with the final editions.
To facilitate your review, the published drafts include a redlined document intended to highlight the changes made to these Standards. Comments on any Standards are welcome; however, we are specifically requesting your comments on the following structural and content changes:
- A single collection section was created in the HCT Standards that includes collection of peripheral blood by apheresis, marrow, and other tissues. This change was introduced to reflect advances in the field and incorporate evolving cell collection types and practices.
- Revisions introduced to standardize practices related to Risk Evaluation and Mitigation Strategies (REMS), incorporating the recommendations from the efforts of the ASTCT (American Society for Transplantation and Cellular Therapy) 80/20 Task Force and the changes to many FDA-mandated REMS programs.
- For each cell collection intended for further manufacturing, new Standards (C7.1.3, C7.3.2, C7.3.5, D7.1.3, and D7.3.2) were introduced recommending the use of the Hybrid label as well as the standardized Chain of Identity Identifier to be assigned before or at the time of collection.
- The Standard for Processing Facility Director qualifications (Standard D3.1.1) has not changed; however, the Standards Committee proposed guidance to consider a pathway for people who do not possess a doctoral level degree to serve as the director.
- New audit requirements were added in Clinical, Collection, and Processing Standards 4.8.4 through 4.8.6.
Download a copy of the draft HCT and IEC Standards at: https://factglobal.org/standards/public-comments/
There are two surveys. Complete the HCT survey if your comments are related to HCT and/or IEC practice. Complete the IEC survey if your comments are related ONLY to the IEC Standards. Additional instructions and access to the surveys can be found at:
https://redcap.link/HCT9_IEC3_public_comments
There is no limit to the number of comments you can submit or the number of surveys you can complete. Up to thirty (30) comments per section are allowed on the survey. If you wish to provide additional comments, please start a new survey.
The draft HCT and IEC Standards have been significantly harmonized and efforts are currently being made to harmonize the Accreditation Manuals for both documents. For this reason, the decision was made not to publish the IEC second edition Accreditation Manual. The manual for the third edition IEC Standards will be published with the third edition Standards.
For questions regarding the Public Comment Survey or the IEC Accreditation Manual, please contact Monique Summers-Currington, FACT Standards Development Manager, at Monique.Summers@factglobal.org.
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