FACT Virtual Inspections Update

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

Virtual inspections are currently being scheduled for those programs whose renewal accreditation process was interrupted in March 2020 due to pandemic-related issues. FACT Accreditation Coordinators have communicated information about the process to the Program Directors, Quality Managers, and the primary contact persons at those Cellular Therapy Programs whose inspections were canceled and those that were being scheduled. The FACT Business Manager Is currently contacting these Programs for potential inspection dates with the goal of completing the renewal process prior to the expiration date of the current accreditation for each Program.

FACT has created a Virtual Inspection Resource page on the FACT website at: http://www.factwebsite.org/virtualinspections/.  Numerous documents have been updated and are available there, including guidelines for applicants and inspectors, technology guides, and examples of timelines and agendas. By popular request, a new OneNote template to organize compliance documentation has been developed for the 7th Edition FACT-JACIE Hematopoietic Standards for Cellular Therapy.  Additional resources will be added to this page as they become available.

Following two successful pilot virtual inspections, participating  program personnel, volunteer inspectors, and FACT staff identified several best practices for a virtual inspection and issues for process improvement.    Several topics were identified as key to the success of the virtual inspection process.  Best practices include:

  1. Organization is key. Using OneNote to organize documents was an extremely helpful tool for both program personnel and inspectors.  In OneNote, SOPs, policies, and other supporting documents and examples are linked directly to the specific FACT Standard and checklist question, making demonstration of compliance efficient and clear.  FACT has created a OneNote template containing the 7th Edition FACT-JACIE Hematopoietic Cellular Therapy Standards that is now available on the Virtual Inspection Resources page.
  2. The pilot inspection teams identified several additional documents that would have been very helpful to review in advance of the inspection. While FACT had not planned to require additional submitted documents, this recommendation is an important process improvement to be implemented immediately. Additional documents should be submitted in the FACT Portal via the Virtual Inspection Documents tab of the Document Library, identified by the relevant Standard number at the beginning of the document title. New documents include:
    • Any policy or SOP specifically referenced in the Quality Management Plan.
    • The most recent Annual Report on the Effectiveness of the Quality Management Program. A list of documents has been added to the Applicant Guidelines in the Virtual Inspection Resource Center.
  3. Be prepared to demonstrate tracking and tracing of products and processes from donor identification through product collection, processing, storage, and administration.
  4. It is recommended that each person participate in the inspection at a separate computer to facilitate efficient responses. Having the applicant team together in one conference room is suitable if all attendees are able to see and hear sufficiently; however, it is easiest if participants are in separate rooms or adequately socially distanced to avoid the need for masks that tend to inhibit communication.
  5. If more than one area (for example, both the adult and pediatric clinical programs, or clinical, apheresis, cell processing) uses the same Quality Management Plan, the applicant program should consider jointly reviewing the Quality Management section with all relevant inspectors. This should be included in the agenda when it is created and shared with the inspection team prior to the inspection.

FACT is pleased that the pilot virtual inspections were successful and the lessons learned can be applied to ongoing renewal inspections.   For initial applicants, or programs with a new service or space being added, an on-site inspection will be required.  FACT continues to monitor inspector availability for travel and will schedule in-person inspections when applicants are prepared and inspectors are available.  Virtual inspections for cord blood banks will begin later this spring.