FACT Update: June 2018

By Content Administrator posted 06-11-2018 18:17


This article appeared in the June 2018 issue of ASBMT eNews. Download the full issue in PDF format here.

By Mikaela VanMoorleghem, Education and Training Coordinator, Foundation for the Accreditation of Cellualar Therapy

FACT Awards First Accreditation Under the New FACT Standards for Immune Effector Cells

FACT awarded accreditation for immune effector cellular therapy under the new FACT Standards for Immune Effector Cells to The University of Texas MD Anderson CARTOX Program, directed by Elizabeth Shpall, M.D., and Sattva S. Neelapu, M.D. This is the first accreditation FACT has awarded to an immune effector cellular therapy program that is independent of a bone marrow transplant program. The program received accreditation on April 19, 2018.

Read the news release

View list of all FACT-accredited immune effector cellular therapy programs 

FACT Webinar: ISBT 128 Labeling and Coding

Full implementation of ISBT 128 labeling and coding is required by the seventh edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards, which becomes effective this month. On Thursday, June 14 at 11 a.m. ET, Dr. Phyllis I. Warkentin will discuss common questions about ISBT 128 terminology, product codes, FACT Standards and regulatory requirements. Webinar participants will have a chance to ask Dr. Warkentin questions at the end of the presentation.

View meeting details and register

Seventh Edition FACT-JACIE Hematopoietic Cellular Therapy Standards Went into Effect May 30

The seventh edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards became effective on May 30. As a reminder, compliance with the new requirements was required by that date. Resources for navigating the new edition of Standards are on the FACT website in the Cellular Therapy Library. Resources include:

FACT-JACIE Hematopoietic Cell Therapy Standards, Seventh Edition

FACT-JACIE Accreditation Manual, Seventh Edition

Purchase Printed Copies

Changes to Seventh Edition FACT-JACIE Standards

FACT-JACIE Cellular Therapy Standards Crosswalk 6th to 7th Edition

FACT-JACIE Cellular Therapy Standards Crosswalk 7th to 6th Edition

A webinar presented by Dr. Paul Eldridge on how to Effectively Transition to the Seventh Edition Hematopoietic Cellular Therapy Standards, was presented on March 14. If you were unable to attend the webinar, you can purchase the recording. FACT inspectors can download the recording for free!

If you have questions related to the seventh edition FACT-JACIE Standards, contact your FACT coordinator or submit your question to askfact@unmc.edu.