by Stacy Freeburg, Accreditation Coordinator
They say the only thing constant is change. This is true for healthcare facilities, which are often rearranged, remodeled, or built new to meet the shifting needs of patients. What does not change, though, is an accredited organization’s responsibility to maintain compliance with FACT Standards throughout a move of cellular therapy-related activities.
FACT used to automatically require an interim inspection of new or relocated facilities so that compliance with Standards could be verified. In 2013, after reviewing several years of relocation inspection results, the FACT Accreditation Committee determined that such inspections are not always required because sufficient information could be provided.
The current policy requires accredited organizations to update FACT within 90 days of a facility relocation and submit specific documentation to demonstrate compliance with FACT Standards. This includes temporary moves. The Chair of the FACT Accreditation Committee reviews the documentation and determines if a relocation inspection is necessary. It is recommended that organizations notify their assigned Accreditation Coordinator in advance if a relocation is planned, and organizations should expect to provide the following information, as applicable:
- A description of the new facility.
- An explanation or reason for the move.
- If the move is temporary, include a timeline for when services will resume at the current location and the revalidation plans for the processes, facilities, and equipment.
- Mailing and physical address of new and old locations, including building, floor, wing, room number.
- Include the distance between the old location and the new location, if applicable.
- Indicate if the new location has been inspected by FACT previously.
- Date operations started at new facility and type of processes.
- The date when the move occurred.
- A risk assessment of the move, including how adequate space and protection from airborne microbial contamination and provision of adequate medications, blood products, and other critical services, were maintained during the relocation.
- A detailed floor plan (with clearly marked rooms, exits, restroom facilities, any isolation rooms, storage areas, irradiators, etc.) and the identification of the new location.
- A summary of any changes to the Quality Management Plan, if applicable.
- A summary of the SOPs that were created or revised because of the relocation, as applicable, and provide an example of a revised SOP.
- A summary of staffing changes, if applicable.
- Include a summary of the validations, revalidations, verifications, or qualifications that were performed due to the relocation.
- Submit a completed example for one of the following: validation, revalidation, verification, or qualification.
- Include a schedule for completing these assessments if not completed at the time of submission.