Updated Donor History Questionnaires Now Available #

HPC, Apheresis and HPC, Marrow DHQ Version 2.0, June 2019
The HPC, Apheresis and HPC, Marrow Donor History Questionnaire materials have been updated to version 2.0. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.9.

HPC, Cord Blood DHQ Version 1.7, June 2019
The HPC, Cord Donor History Questionnaire materials have been updated to version 1.7. The changes update some FDA guidance document names, dates, and/or website links, located within the DHQ, to the current version. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.6.

FACT Announces April and May 2019 Accreditations #

During April and May of 2019, 16 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.

Feedback Requested: FACT-JACIE Standards #

Preparation of the Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration will commence this summer. Final publication is expected in March 2021.

FACT and JACIE invite you to complete a short survey focusing on general concepts of interest. You are also encouraged to promote this survey in your national or regional professional society. Responses will be accepted through June 15, 2019.

The results of this survey will be reported to the Standards Steering Committee for review and consideration.

Complete Survey

FACT Announces 2018 Fourth and 2019 First Quarter Accreditations #

During the fourth quarter of 2018 and first quarter of 2019, 40 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.

FACT Submits Comments to CMS Regarding Proposed National Coverage Determination for CAR T-Cell Therapies for Cancer #

The United States Centers for Medicare & Medicaid Services (CMS) released a proposed decision memo that outlines coverage for CAR T-cell therapies for cancer using a National Coverage Determination (NCD) with Coverage with Evidence Development (CED). FACT responded to this proposal on March 15, 2019. Comments were a result of input from a variety of stakeholders, including the FACT Board of Directors and Immune Effector Cell Task Force, FACT-accredited programs, FACT inspectors, professional societies, data registries, manufacturers, and payers. We commend the cellular therapy field for its collaborative efforts to provide feedback that would be helpful to CMS as it seeks to provide beneficiaries access to CAR T-cells, and we appreciated this opportunity to provide feedback.

Highlights of FACT’s comments include:

• Suggestion that coverage is provided based on Food and Drug Administration (FDA)-approved product labels to allow coverage as therapies advance.
• Support for the use of the Center for International Blood and Marrow Transplant Research (CIBMTR) as the data registry, and suggestion to certify the registry prior to finalization of the proposed decision memo.
• Request for clarification on the utility of quality of life data for the stated purposes.
• Clarification regarding the scope of various sets of FACT Standards.
• Agreement that hospitals should meet FACT requirements to promote safety and efficacy of CAR T-cell therapies; increase harmonization across requirements of regulators, payers, and manufacturers; and reduce burden on hospitals.

Read comments

FACT Publishes Second Edition of Common Standards #

The Second Edition FACT Common Standards for Cellular Therapies was published March 15, 2019. Programs accredited under the FACT Common Standards must be in compliance with these Standards by June 15, 2019.

The major objective of these Standards is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in 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.

These Standards apply to:

• Cells collected from non-hematopoietic sources (e.g., adipose tissue).
• Cells collected from hematopoietic sources for non-homologous use (e.g., mesenchymal stromal cells for cardiac repair).

The updated Standards and summary of changes are available on the FACT website for reference. Printed copies of the Standards may be purchased from the FACT store. Read more

FACT Common Standards, Second Edition
Purchase Printed Copies
Summary of Changes to FACT Common Standards, Second Edition
FACT Common Standards Crosswalk First to Second Edition
FACT Common Standards Crosswalk Second to First Edition

Draft Seventh Edition NetCord-FACT International Cord Blood Standards Available for Public Comment #

The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Seventh Edition of the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration and accompanying Accreditation Manual for inspection and public comment for a 90-day period. Comments will be accepted from November 30, 2018 through April 1, 2019.

The Standards apply to all phases of cord blood collection, banking, and release for administration, including donor management, collection, processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, and distribution to clinical programs.

Description and Instructions for Review and Comment
Draft NetCord-FACT Cord Blood Standards
Draft NetCord-FACT Accreditation Manual

Comments regarding the draft Seventh Edition NetCord-FACT Cord Blood Standards can be submitted by accessing the Comment Form. Comments will be accepted through April 1, 2019.