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.
Page last reviewed: September 9, 2020
Content source: Division of Regulatory Science and Compliance