Public Review and Comment

DRAFT FACT-JACIE Ninth Edition Hematopoietic Cellular Therapy and Third Edition Immune Effector Cell International Standards

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) have published a preliminary draft of both the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Ninth Edition (HCT Standards) and the FACT-JACIE International Standards for Immune Effector Cells, Third Edition (IEC Standards). These drafts are now open for public comments which will be accepted through December 15, 2024.

The field of cellular therapy is continuously evolving, and our goal for each new edition of the Standards is to accurately capture and reflect those changes to remain a relevant and useful resource for programs. The comments, suggestions, and feedback solicited during the public comment period are not only welcome, but vital to ensuring that we achieve this goal. Participating in our public comment survey is a direct way to make your thoughts known because each comment is reviewed by the Standards Committee. Additionally, responses to the comments received during this period will be published alongside the final version of the Standards.

The review for both the HCT and IEC Standards includes multiple structural and content changes for which we are requesting specific comments.  These include:

• A single collection section was created which includes apheresis, marrow, and other tissue sources.  This change was introduced to reflect advances in the field and incorporate evolving cell collection types and practices.
• Standards and edits introduced to standardize practices related to Risk Evaluation and Mitigation Strategies (REMS).
• New audit requirements were added in Clinical, Collection, and Processing Standards 4.8.4 through 4.8.6.
• New Standards recommending use of the hybrid label and the Chain of Identity Identifier as defined by ISBT 128 Standards (C7.1.3, C7.3.2, D7.1.3, and D7.3.2) to be assigned before or at the time of collection to each collection intended for further manufacturing.
• The Standard for Processing Facility Director qualifications (D3.1.1) has not changed.  The committee proposed did propose guidance to consider a pathway for people who do not possess a doctoral level degree to serve as the director.

There are two surveys.  Complete the HCT survey if your comments are related to HCT or HCT and IEC practice. Complete the IEC survey if your comments are related to only IEC practice. Additional instructions can be found in the surveys at HCT and IEC Standards Survey.

Download  the draft HCT 9th Ed. Standards and draft HCT 9th Ed. Redline Standards for review.

Download the draft IEC 3rd Ed. Standards and draft IEC 3rd Ed. Redline Standards for review.

Download the draft Summary of Changes for both HCT and IEC Standards to assist with your review.

Submit your comments on the draft Standards at: HCT and IEC Standards Survey.

There is no limit to the number of comments you can submit. This survey allows you to enter up to thirty (30) comments per section.  If you wish to provide additional comments, please start a new survey.

For questions regarding the survey, please contact Monique Summers-Currington, FACT Standards Development Manager at Monique.Summers@factglobal.org.

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 to 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.

To submit a comment please email Monique Summers, Standards Development Manager at Monique.Summers@factglobal.org.