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Chapter 25 : Measuring Biosafety Program Effectiveness

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Measuring Biosafety Program Effectiveness, Page 1 of 2

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Abstract:

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 (BMBL).

Citation: Peterson J, Hashimoto R. 2006. Measuring Biosafety Program Effectiveness, p 445-457. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch25

Key Concept Ranking

Hepatitis B
0.625
Bacillus subtilis
0.57269615
0.625
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References

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1. Animal and Plant Health Inspection Service. 2005. Agricultural Bioterrorism Protection Act of 2002; Possession, Use and Transfer of Biological Agents and Toxins; final rule (7 CFR Part 331 and 9 CFR Part 121). Fed. Regist. 70:1327813292.
2. Centers for Disease Control and Prevention. 2005. Possession, Use, and Transfer of Select Agents and Toxins; final rule. (42 CFR Part 73). Fed. Regist. 70:1331613325.
3. Centers for Disease Control and Prevention and National Institutes of Health. 1999. Biosafety in Microbiological and Biomedical Laboratories, 4th ed. U.S. Government Printing Office, Washington, D.C.
4. National Institutes of Health. 2002. NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), 59 FR 34496 (July 5, 1994), as amended. [Online; the current amended version can be accessed athttp://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.]
5. Occupational Safety and Health Administration. 1991. Occupational exposure to bloodborne pathogens (29 CFR 1910.1030). Fed. Regist. 56:6417564182.

Tables

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TABLE 1

Factors to consider when selecting inspectors

Citation: Peterson J, Hashimoto R. 2006. Measuring Biosafety Program Effectiveness, p 445-457. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch25
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APPENDIX A

BSL-2 CHECKLIST

Citation: Peterson J, Hashimoto R. 2006. Measuring Biosafety Program Effectiveness, p 445-457. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch25
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APPENDIX B

SAMPLE rDNA AMENDMENT FORM

Citation: Peterson J, Hashimoto R. 2006. Measuring Biosafety Program Effectiveness, p 445-457. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch25
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APPENDIX C

SAMPLE RE-VERIFICATION CHECKLIST

Citation: Peterson J, Hashimoto R. 2006. Measuring Biosafety Program Effectiveness, p 445-457. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch25

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