FACT News

FACT Standards Available for Public Comment #

The draft Eighth Edition FACT-JACIE International Standards and draft Second Edition FACT Standards for Immune Effector Cells are available for review and comment through August 30, 2020.

Read the draft Standards, Summary of Changes, and instructions for submitting comments.

FACT Announces Accreditations in June 2020 #

In June 2020, seven 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.

Please Complete Survey to Support Apheresis Cell Collection Standardization Efforts #

As the fields of cell and gene therapies grow, so may the burdens on both apheresis cell collection centers and industry. Standardization of some common collection parameters may reduce this burden on both. Improved consistency and standardization would also improve product quality and potentially improve patient outcomes while reducing errors and audit fatigue.

The Standards Coordinating Body has convened a working group of experts from industry, apheresis cell collection centers, processing laboratories, accreditation bodies, research centers, and other stakeholders to work towards these goals.

We've developed two surveys to assess current practices, which take approximately 20 minutes to complete:

For Industry: https://cell-collection-for-industry.questionpro.com

For Apheresis/Cell Collection Centers: https://apheresis-center-survey.questionpro.com

On behalf of the subject matter experts who drafted this survey, and the Standards Coordinating Body, thank you for your time and your essential contribution to this standard development initiative.

FACT Announces Accreditations in April and May 2020 #

In April and May 2020, 5 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, alongside ASTCT, CIBMTR, ISCT, and EBMT, issue a joint statement against racism #

Joint Statement from ASTCT, CIBMTR, FACT, ISCT and EBMT

Racism has no place in our society and profession. The American Society for Transplantation and Cellular Therapy (ASTCT), the Center for International Blood and Marrow Transplant Research (CIBMTR), Foundation for the Accreditation of Cellular Therapy (FACT), the International Society for Cell & Gene Therapy (ISCT), and the European Society for Blood and Marrow Transplantation (EBMT) all find these acts of racism reprehensible and inexcusable. This cannot be ignored any longer by the global community and our respective organizations.
Read full statement

FACT Announces Accreditations in March 2020 #

In March 2020, 4 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.

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.




		
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Accreditation Success Story

The University of Utah Blood and Marrow Transplant Program began at the University Hospital in Salt Lake City in 1990. The program has been FACT accredited for 10 years, and offers suggestions for large programs considering FACT accreditation. Read more