Update on FACT Virtual Inspections
FACT has initiated its accreditation renewal process with virtual inspections starting with two programs whose renewal inspections were delayed in March 2020 due to the COVID-19 pandemic. By all accounts, the virtual inspections were successful! The applicant programs were well prepared, the processes were generally effective, inspectors were able to verify compliance with Standards, and both inspectors and program staff continued to learn throughout the process. As a result, FACT is now scheduling virtual inspections for additional programs whose inspections were delayed, followed by those who were in the process of scheduling inspections when the pandemic started. Program Directors, Quality Managers, and primary contact persons at eligible programs should expect direct communications from their FACT Accreditation Coordinators to begin this scheduling.
The FACT Virtual Inspection Task Force developed this virtual process over the past several months to closely mimic the in-person experience to the extent possible, including submission of the same documents to the FACT Accreditation Portal in advance and review of these documents by the Inspection Team. The FACT Accreditation staff participated in training the applicants and inspectors in the technical skills required for the virtual process. Members of the Task Force volunteered their own programs to serve as pilot programs for the virtual inspection process, and volunteered themselves to be the first inspectors. The two pilot programs included clinical transplant and immune effector cellular therapy sites, bone marrow and apheresis collection services, and cellular therapy product processing facilities with minimal and more than minimal manipulation processing. Each pilot inspection took place over two days using individual secure Zoom calls, during which the inspectors were able to view documents and pre-recorded facility video tours and interview various members of the applicant program (including nurses; advanced practice professionals; pharmacists; ICU, ER, and Radiation Oncology staff; data managers; and clinical research associates. Program staff shared records, minutes, policies, SOPs, and other documentation by sharing a computer screen for electronic or scanned documents or by using a cell phone or document camera for other types of documentation such as paper files, logs, and records.
Task Force members and FACT staff observed portions of these pilot inspections and are currently assessing the processes. At least two important themes have been identified to date. First, it is important for the applicant program to be well organized with documentation prepared in the order of the FACT Standards. Use of Microsoft OneNote or other electronic programs to link program documentation to a specific FACT Standard is very helpful to allow efficient location and display of relevant policies and SOPs. Once created, this tool can be used to continuously update documentation and maintain inspection-readiness through the accreditation cycle. Second, the inspection goal is to demonstrate implementation of required policies and SOPs through examples. Identification and organization of these patient records, meeting minutes, validation studies, audit reports, and other quality documents according to the specific standard facilitates demonstration of compliance. While neither of these concepts is new, the virtual process magnifies the importance of careful organization.
Additional details of the inspection process are available on the FACT Virtual Inspection Resource Center at: http://www.factwebsite.org/virtualinspections/. Numerous documents are available, including timelines, sample inspection agendas, applicant and inspector guidelines for the virtual process, organization tips, and technical information related to Zoom and document sharing methodologies.
As the next group of programs is ready for inspection, additional training will be held for currently active cellular therapy program inspectors. A full inspector training course for new inspectors that will include both the in-person and virtual inspection processes is planned for early summer. This virtual inspection process is intended for renewal applications only. Initial accreditation visits will be in person and will be scheduled when it is safe to do so and appropriate inspectors are available to travel. Virtual inspections for cord blood banks will begin this spring. New applicants for initial accreditation will require an in-person inspection that will be scheduled and fulfilled as appropriate inspectors are available.
FACT is grateful for the extra effort on the part of these pilot programs and inspectors. The Virtual Inspection Task Force includes members of the Cellular Therapy Accreditation Committee, the Inspector Development Committee, and the Board of Directors.
