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This chapter provides mechanisms for the evaluation of the components of a biosafety program and gives examples of tools that can be used for this process. A biosafety program may include blood-borne pathogens, infectious materials, diagnostic specimens, recombinant-DNA (rDNA) oversight, management of biosafety cabinet (BSC) certification, and/or the select agent program. The most common method used to evaluate a biosafety program is an audit of the laboratory. Biosafety manager, self-inspection, safety generalist, outside consultant and regulatory agency are explained in this chapter. One logical way to evaluate a component of the biosafety program is through review of records and documentation rather than a site visit. In many institutions the biosafety program manages the BSC certification program. The chapter discusses annual reverification of biosafety level 3 (BSL-3) laboratories. Inspection should be scheduled well in advance to ensure that laboratory experiments are not in progress, since the annual reverification focuses on facility operations and is not a review of laboratory procedures. A BSL-3 facility should be reverified on an annual basis to ensure that it continues to meet the BSL-3 criteria stated in Biosafety in Microbiological and Biomedical Laboratories (BMBL). |
