FACT initiated a virtual inspection process in January 2021 to enable accredited cellular therapy facilities to complete their renewal accreditation. This process will be in place as long as necessary to minimize the coronavirus pandemic risks to our cellular therapy community, volunteers, and patients. We plan to return to in-person inspections when it is safe to do so. A virtual inspection process for cord blood banks will begin in February.
New applicants for initial accreditation will require an in-person inspection. These inspections will occur as inspectors are available.
Virtual inspections will mimic the in-person experience to the extent possible. The platform for the interactive virtual inspections is a FACT HIPAA-compliant Zoom Healthcare account that has been determined to be sufficient to safeguard the virtual process. In addition, all FACT staff and volunteers annually sign Confidentiality and Conflict of Interest Agreements, and FACT has a Business Associate Agreement in place with each accredited and applicant program to cover confidentiality issues, including protected health information that may be viewed but not recorded or retained as part of the accreditation process.
Training in the virtual inspection process was conducted for applicants on February 4, 2021 immediately preceding the annual Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR and for inspectors later in February. These presentations were recorded and remain available on the FACT website. In addition, FACT Accreditation Coordinators will assist each applicant program and inspection team with additional hands-on training as needed prior to the inspection.
Numerous resources are available here to assist applicants and inspectors in preparation for virtual inspections.
The following is a list of resources to assist inspectors who will be performing virtual inspections:
The following is a list of resources to assist applicants preparing for an upcoming virtual inspection: