Virtual Inspection Resource Center
FACT initiated a virtual inspection
process in January 2021 to enable accredited cellular therapy facilities to
complete their renewal accreditation. We
expect this process to 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.
Priority for virtual inspections
will be given to cellular therapy programs whose on-site inspections were
canceled, then to those who were in the process of scheduling when the on-site
inspections were suspended in March 2020. 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
will be 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 will be 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.
Inspectors
The following is a list of resources to assist inspectors who will be performing virtual inspections:
Applicants
The following is a list of resources to assist applicants preparing for an upcoming virtual inspection: