Annual Inspection Guidance: Other Areas for Consideration for Annual Review

The RO may utilize the internal inspections to ensure compliance with other parts of the regulations such as to:

• Establish a schedule for recertification and service of laboratory equipment (e.g., biosafety cabinets, autoclaves, HEPA filters) to prevent potential biocontainment lapses.
• Conduct an annual inventory check, which may be all-inclusion or spot checks of the inventory. The inventory check should include a review of the entity’s inventory recordkeeping procedures to ensure that individuals with access to inventories follow appropriate procedures for access and recording changes to the inventory.
• Review the biosafety/biocontainment, security, and incident response plans annually to ensure that any changes in facility operations are appropriately captured.
• For entities performing a validated inactivation procedure for removal of viable select agent, review procedures, validation data and certificates.