FACT Introduces New Intermediary Storage Checklist
By Sarah Litel-Smith, BSMT (ASCP), Manager of Accreditation Services
FACT has developed a new Intermediary Storage Checklist in response to the increasing use of temporary storage locations outside the direct oversight of the Clinical Program, Collection Facility, or Processing Facility. The checklist supports review of temporary storage sites—such as pharmacies, blood banks, or laboratories outside the processing facility—that store cellular therapy products between key points in the product lifecycle.
This shortened, targeted checklist is issued within applicable Cellular Therapy Compliance Applications when an intermediary storage site is identified. It supports review and documentation to confirm that cellular therapy products are secure, maintained at appropriate temperatures, traceable, and managed by trained staff. It also supports evaluation of key processes, including product receipt into storage, release from storage, response to storage alarms, temperature excursions, damaged containers, and leaking product containers.
A key focus of the checklist is chain of custody. Cellular therapy products must be continuously accounted for throughout the product lifecycle, including collection, processing, storage, shipment, transportation, and other points of transfer. Documentation must clearly identify the product’s location, status, and the designated party responsible for the product at each applicable step.
Although the checklist questions are derived from the Processing Standards, they should be answered in relation to the storage services performed by the intermediary storage site. Programs should complete the checklist sequentially in the FACT Accreditation Portal, as some questions include logic that will remove non-applicable follow-up items based on prior responses. Many questions also include an option to indicate when a requirement is not applicable. Programs are encouraged to use the optional comment field to provide brief explanations for the FACT office and inspection team.
When completing the Processing Facility Grid, storage-only facilities are required to complete Table 2: Storage Facility Demographics only. The general processing facility demographics and processing activity tables do not apply unless the storage site performs processing activities.
Some requirements may appear similar to items addressed elsewhere in the Compliance Application, such as chain of custody, chain of identity, internal transfer, personnel safety, and use of personal protective equipment. However, these topics apply across multiple areas of operation and must be demonstrated within the context of the specific service being evaluated.
This checklist reflects FACT’s continued commitment to patient safety, product traceability, and documented accountability across the full continuum of cellular therapy.
