Many New Developments in FACT Standards Development Activities

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

The FACT Standards Committees have been busy reviewing feedback, discussing new developments in cellular therapy, and editing drafts for several different sets of Standards. Updates for each set of Standards are provided below. As progress continues, important updates will be announced via weekly emails and future Just the FACTs newsletters.

FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, 7th Edition

FACT and JACIE are finalizing the 7th edition Hematopoietic Cellular Therapy Standards, which is scheduled for publication in March 2018.  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, and administered by a blood and marrow transplant (BMT) team.

After March 1, 2018, only Compliance Applications under the 7th edition will be accepted and only inspections under this new edition will be conducted after the effective date of May 30, 2018. Programs currently pursuing renewal or initial accreditation under the 6th edition must remain mindful of these dates and ensure timely submission of pre-inspection materials and completion of the inspection.

The FACT Accreditation Services department is contacting accredited and applicant programs who will be beginning the accreditation process at the time of publication to discuss the transition. We understand the effort required to complete the accreditation process and will be ready to assist programs with timely submission of the Compliance Application in accordance with the new edition.

The FACT-JACIE Standards Steering Committee meets in Orlando to review the 7th edition draft Standards.









FACT Standards for Immune Effector Cells, 1st Edition

The FACT Standards for Immune Effector Cells apply to immune effector cellular (IEC) therapy programs that are independent of a transplant program. Standards specific to IEC therapy are also contained within the FACT-JACIE Hematopoietic Cellular Therapy Standards for programs that perform both transplant and IEC therapy. To ensure both sets of Standards include the most up-to-date requirements in this new field, requirements will be published in an interim version of the 1st edition Immune Effector Cell Standards. Once effective, the updated version of the Standards will be the basis of inspections going forward.

A list of the small number of changes to the Immune Effector Cell Standards will be provided at the same time the 7th edition Hematopoietic Cellular Therapy Standards are published in March 2018.

FACT Common Standards for Cellular Therapies, 2nd Edition

The FACT Common Standards for Cellular Therapies is currently undergoing revision. The Common Standards Committee consists of members representing a wide variety of specialties to ensure the Common Standards continue to represent the basic fundamentals applicable to any type of cellular therapy.  This includes hematopoietic progenitor cell (HPC) transplantation, IEC therapy, cardiovascular medicine, cord blood banking, cell collection, and cell processing with minimal and more-than-minimal manipulation. A draft for public review and comment is expected in April 2018.

NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, 7th Edition

The Steering Committee for the 7th edition of NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration will initiate the development process at the 2018 BMT Tandem Meetings in February.

FACT and WMDA-NetCord invite you to complete a short survey focused on general concepts of interest regarding the Standards. The results of this survey will be reported to the Standards Steering Committee for review and consideration as it begins to draft the next edition. Your input helps maintain the clarity, usefulness, and relevance of the Standards. Responses will be accepted through December 29, 2017. The 7th edition is scheduled for publication in October 2019.

Complete the survey