FACT News

CBA Study Compares Standards and Accreditations #

The Cord Blood Association (CBA) Quality Standards Committee report is the result of an extensive review and analysis of banking standards, as well as questions posed to AABB and the Foundation for the Accreditation of Cellular Therapy (FACT). The report compares:

  • ways in which the standards are identical, similar, and different
  • each agency’s standards development process
  • methods by which compliance is determined and inspections conducted

The study was requested by the CBA Board of Directors to assist banks that are seeking accreditation from one or both accrediting organizations. Read the full study

Draft 2nd Edition FACT Common Standards Available for Public Comment #

The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft 2nd edition FACT Common Standards for Cellular Therapies for public comment during a 60-day period. Comments will be accepted from June 1, 2018 through July 31, 2018.

These Standards represent the basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials.

The final Standards will be published on March 15, 2019 and will become effective on June 13, 2019.

Description and Instructions for FACT Common Standards
Draft 2nd Edition FACT Common Standards

To submit comments regarding the draft 2nd edition FACT Common Standards, follow the steps below. Comments will be accepted through July 31, 2018.

  1. Access the Comment Form at https://www.surveymonkey.com/r/FACTPublicComment
  2. Type in your contact information and comments on the form. Fill in all fields to ensure the Standards Committee fully understands your position.
  3. Submit the form when you are finished. Once the form has been submitted, it cannot be changed. However, additional comments may be submitted by completing the form again. There is no limit to the number of forms that can be submitted.

FACT Announces Accreditations Awarded in First Quarter of 2018 #

During the first quarter of 2018, 25 entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.

The University of Texas MD Anderson CARTOX Program is First to Achieve Accreditation Under the FACT Standards for Immune Effector Cells #

OMAHA, Neb. — The University of Texas MD Anderson CARTOX Program received accreditation for immune effector cellular therapy by the Foundation for the Accreditation of Cellular Therapy (FACT) at the University of Nebraska Medical Center. The University of Texas MD Anderson CARTOX Program, directed by Elizabeth Shpall, MD, and Sattva S. Neelapu, MD, is the first program to be recognized by FACT for compliance with the new FACT Standards for Immune Effector Cells independent of a bone marrow transplant program. The program received accreditation on April 19, 2018. Read full release

FACT and JACIE Publish Seventh Edition of Hematopoietic Cell Therapy Standards #

The seventh edition of the FACT-JACIE Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration has been published. FACT-accredited hematopoietic progenitor cell (HPC) transplantation programs must be in compliance with these Standards by May 30, 2018. The updated Standards, accompanying Accreditation Manual, and summary of changes are available on the FACT website for reference. Printed copies of the Standards and Accreditation Manual may be purchased from the FACT store.

The major objective of these Standards is to promote quality medical and laboratory practice in HPC transplantation and related therapies using hematopoietic-derived cellular products. These Standards apply to:

  • HPCs, and nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs.
    • For HPCs or mononuclear cells derived from umbilical cord or placental blood, these Standards apply only to the administration of the cellular therapy product. Standards for cord blood collection and banking are available in a separate document, the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, available at www.factwebsite.org.
  • Immune effector cells (IECs) derived from hematopoietic sources, defined broadly as any cells, in vitro modified or not, that are capable of eliciting or modulating an immune response.
    • Stand-alone immune effector cell therapy programs that do not perform HPC transplantation should reference the FACT Standards for Immune Effector Cells

FACT-JACIE Hematopoietic Cell Therapy Standards, Seventh Edition
FACT-JACIE Accreditation Manual, Seventh Edition
Changes to Seventh Edition FACT-JACIE Standards
Purchase Printed Copies

Now Available – Version 1.1 of FACT Standards for Immune Effector Cells #

To promote consistency with the new edition of the FACT-JACIE Standards for Hematopoietic Cell Therapy, Version 1.1 of the FACT Standards for Immune Effector Cells is now available. These requirements will become effective on May 30, 2018. The major objective of these Standards is to promote quality practice in IEC administration. The requirements are for programs that administer IECs on a unit that does not also perform HPC transplantation.  When IECs are administered on a FACT-accredited HPC transplant unit, the program must fully comply with the FACT-JACIE Hematopoietic Cell Therapy Standards.

FACT Standards for Immune Effector Cells, First Edition 1.1
FACT Immune Effector Cell Accreditation Manual, First Edition 1.1
Changes to First Edition FACT Immune Effector Cell Standards
Purchase Printed Copies

FACT Announces Accreditations Awarded in Fourth Quarter of 2017 #

During the fourth quarter of 2017, 37 entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.




		
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Accreditation Success Story

Hoxworth Blood Center Apheresis Collection Facility and its Cellular Therapies Division have been accredited by FACT since 2003. The program values their FACT accreditation and the impact it has had on their program’s continuous quality improvement objectives. Read more