UPDATE: 17 March 2020
Program Directors, Medical Directors, and Quality Managers:
The health and safety of our cellular therapy community continues to be our utmost concern as we all work to mitigate the effect of the COVID-19 pandemic. Due to travel restrictions and CDC recommendations for social distancing, FACT has postponed all scheduled on-site inspections through June 30, 2020. Rescheduling of these and additional inspections will resume when an appropriate timeline can be determined. We will continue to follow recommendations from the CDC, health officials, and governmental agencies.
There have been many questions related to delays and postponements of on-site inspections due to travel restrictions and recommendations for social distancing.
Effective immediately, the accreditation expiration date for all FACT-accredited organizations will be extended by six months. This includes all clinical hematopoietic cell transplant programs, immune effector cell programs, apheresis centers, laboratory facilities, and cord blood banks, regardless of the current expiration date. This is our current best estimate of an appropriate timeline, however, if circumstances warrant, additional extensions will be implemented. New accreditation certificates will be prepared and distributed to eliminate confusion. The official list of accredited organizations is available at factwebsite.org.
To the extent possible, programs should continue to submit documents and complete Compliance Applications during this period when on-site inspections are not being scheduled. FACT staff are available by phone or email to receive and review this information, and to provide other assistance as needed.
Published March 13, 2020
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.
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.
In addition, FACT global partner The World Marrow Donor Association (WMDA), has provided international blood and tissue donor guidelines and resources for cord blood banking including:
- Cord Blood Support Service
- Information specified per country (on restrictions on import/export)
- Donor suitability criteria
- European Centre for Disease Prevention and Control
If you have questions, or concerns, please contact the FACT office at 402-559-1950 or firstname.lastname@example.org.