FACT News
COVID-19 Update: FACT Accreditation #
The health and well-being of our cellular therapy community, volunteers, staff, and patients is our utmost concern as new cases of Coronavirus are reported across the US and around the world. We are continuing to monitor recent developments surrounding the coronavirus (COVID-19) pandemic and are focused on recommendations from the CDC, health officials, and government agencies.
Numerous institutions have implemented travel policies banning both domestic and international travel for their employees, including our FACT inspectorate. Organizations should anticipate postponements and delays in scheduling. We understand the inconvenience; however, these restrictions represent the best effort to safeguard the health of all involved. We thank you for your
understanding and cooperation as we work together to meet the challenges posed by COVID-19.
Please be assured that organizations’ accreditation will not lapse due to these circumstances. Additional time will be allotted in the accreditation process. Refer to Frequently Asked Questions: FACT and COVID-19.
Our parent society, the American Society for Transplantation and Cellular Therapy (ASTCT) and its Infectious Disease Special Interest Group have developed interim guidelines for COVID-19 management of HCT and cellular therapy patients. These guidelines will be modified as new information becomes available, including more data on epidemiology, clinical outcomes, and efficacy
of drug therapies including clinical trials of novel therapeutics.
COVID-19 Interim Patient Care Guidelines
In addition, FACT’s global partner The World Marrow Donor Association (WMDA), has provided international blood and donor guidelines and resources for cord blood banking including:
For additional resources, please consult the World Health
Organization and the Centers For
Disease Control.
If you have questions, or concerns, please contact the FACT office at 402-559-1950 or fact@unmc.edu.
FACT Announces Accreditations November 2019 - February 2020 #
From November 2019 through February 2020, 27 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.
Comments Requested on Standard Labeling Proposed for Apheresis Collection Products: Due March 20, 2020 #
FACT is pleased to announce that ICCBBA, administrator of the ISBT 128 coding and labeling standard, has released a draft document and label for public review and comment. The document, “Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing,” and the described label applies to collected cells, commonly referred to as “starting material,” intended for further manufacturing in support of clinical cellular therapy trials and commercial cell products. This draft is a result of a multi-stakeholder effort to standardize labeling requirements of apheresis collection facilities, including the Standards Coordinating Body, the Deloitte NextGen Industry Working Group, FACT, and many others.
Variations in sponsors’ labeling requirements have been a notable challenge for apheresis facilities in recent years and introduce risks of errors and misinterpretation of patient data. The use of an ISBT 128-compliant label will reduce manual transcription errors and promote chain of identity, including for autologous cells. Furthermore, the use of ISBT 128 for these collections will allow the use of processes, labels, equipment, and software compatible with those already in use for other types of cellular therapy products collected by apheresis facilities for clinical application.
The next step of this important standardization effort is to solicit input from the entire community. Please review this document and provide comments by March 20, 2020 to Dawn Henke of the Standards Coordinating Body (dhenke@regenmedscb.org). Equally important, please distribute this announcement to your industry, hospital, vendor, and professional colleagues to make them aware of this opportunity and encourage them to review the document and submit feedback.
Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing
Submit Comments (due March 20, 2020)
News Release: Biology of Blood and Marrow Transplantation Publishes Article on FACT Clinical Outcome Review Process #
 | NEWS RELEASE
Issued: November 21, 2019
Contact: Linda Miller |
OMAHA, Neb. - The journal Biology of Blood and Marrow Transplantation (BBMT) published the article, Integration of Publicly Reported Center Outcomes into Standards and Accreditation: The FACT Model (LeMaistre et al, 2019). Combining historical information with aggregate data collated from corrective action plans (CAPs) submitted to FACT, the article provides an overview of FACT’s process for evaluating one-year survival and preliminary themes found in CAPs.
Read full news release
FACT Announces Accreditations - October 2019 #
In October 2019, six 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 Announces Accreditations June - September 2019 #
From June through September 2019, 20 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.
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.