In response to the COVID-19 pandemic, FACT initiated a virtual inspection process in lieu of an on-site visit for those cellular therapy and transplant programs seeking to renew their accreditation. As travel conditions and personnel availability allowed, in-person inspections were maintained for programs seeking initial accreditation or adding new services. Since virtual inspections began in January 2021, FACT has completed over 50 virtual and 20 in-person inspections. We extend sincere thanks and congratulations to the outstanding volunteer inspectors and diligent applicant program personnel who have worked together to accomplish these accreditations, learn from the experience, and make lasting improvements in the accreditation processes.
Overall, the virtual inspection process has been successful. Although most inspectors and applicant programs prefer the in-person process, inspectors have been able to virtually review the necessary documents and observe physical facilities as well as adequately assess standards compliance. FACT acknowledges there have been challenges for all involved, including learning new technologies and methodologies, and accommodating scheduling delays. Program personnel have worked diligently to update documents in their compliance application to the current versions and to submit newly required documents that facilitate inspector preparation. The requirement for the program to submit to the Accreditation Portal all policies and Standard Operating Procedures (SOPs) referenced in the Quality Management Plan has enhanced inspector understanding of the applicant program. The value of inspector review of these documents in advance is an important lesson learned from the virtual inspection process. This practice is an accreditation process quality improvement that will be retained when in-person inspections resume.
Inspection Requirement: OneNote or the Equivalent
A second lesson learned through the virtual inspection process is not new, but its importance has been amplified in the virtual setting. Organization is key to a successful inspection! Since July 2021, FACT has required the use of OneNote or an equivalent system for organizing documents in preparation for a virtual or on-site inspection. OneNote is a tool that allows linkage of the documents used to demonstrate compliance to the specific FACT Standard, thereby facilitating rapid accessibility for review. To assist applicants in preparation, FACT has created a OneNote template corresponding to each edition of Standards. These can be found on the FACT website under Applicant Resources. Applicants can also refer to the “How to Prepare for a FACT Virtual Inspection” video in the Virtual Inspection Resource Center for additional tips on using OneNote to prepare for the inspection and maintain compliance.
Other software programs are available that permit similar linkage of the Standard to appropriate documentation and are appropriate for the inspection process. Alternatively, applicants could use a completed Self-Assessment Tool or Compliance Application checklist exported from the Accreditation Portal, with the addition of a column that links to the appropriate document and a description of where in the document compliance is found. A comment added to the Compliance Application when it is completed will facilitate this process. When inspections are in-person, paper binders could be assembled that include all relevant documentation. The important point is that the standards must be linked to documentation of compliance, and those documents must be readily available for inspector review. Simple storage apps or programs such as Box, are not adequate to meet this requirement.
FACT does not anticipate further accreditation expiration date adjustments. We are currently working diligently to schedule and complete cellular therapy program inspections that have applications submitted under the seventh edition Standards and begin those inspections to be conducted under the eighth edition. In addition, cord blood bank virtual inspections will begin in March. Scheduling takes into account the date the application was complete and the accreditation expiration date; however, some programs may experience additional delays. Applicant programs are welcome to contact their FACT Accreditation Coordinator with any questions. Programs approaching their accreditation expiration date due to delays from the pandemic or inspection scheduling will not be at risk of losing accreditation. The accreditation status of each program and cord blood bank is official as listed on the FACT website.