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Biosafety Program Development

Biosafety Program Development. Presented by: Lisa Wisser, CIH AIHCE - June 6, 2001. Outline. Who Needs a Biosafety Program? Program Elements Program Management. You Need a Program When. You use Risk Group 3 or 4 agents Otherwise: Are you using Risk Group 2 agents or materials?

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Biosafety Program Development

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  1. Biosafety Program Development Presented by: Lisa Wisser, CIH AIHCE - June 6, 2001 1-0200

  2. Outline • Who Needs a Biosafety Program? • Program Elements • Program Management 1-0200

  3. You Need a Program When... • You use Risk Group 3 or 4 agents • Otherwise: • Are you using Risk Group 2 agents or materials? • …in high concentrations or large quantities? • …in aerosol generating procedures? 1-0200

  4. You Need a Program When... • Regulators insist • OSHA - Bloodborne Pathogens • CDC - Select Agents and Toxins • NIH - Recombinant DNA • USDA APHIS - Plant Pathogens 1-0200

  5. You Need a Program When... • No matter what agents or materials are used: • One of your employees develops a laboratory-acquired infection • Your researchers disregard standard microbiological practices or lack training in microbiology • Your customer requires a program 1-0200

  6. CDC Maximum Containment Laboratory, Atlanta 1-0200

  7. 1-0200

  8. Biosafety Program Goals • Assist laboratory research and support personnel in working safely with biological agents and materials • Meet regulatory requirements and guidelines • Provide a competitive advantage to the organization 1-0200

  9. Program Development Go! Tools Committee Needs assessment Management support 1-0200

  10. Go! Tools Committee Needs assessment Management support Program Development 1-0200

  11. Program Elements • Management support • Laboratory management • Responsible for safety in the laboratories • Facility management • Facility maintenance and improvement • EHS management • Technical support • Program coordination 1-0200

  12. Program Elements • Needs Assessment • Listen to the research staff • Facility walkthrough • Inspection form • Keep records and follow up • Report to Committee 1-0200

  13. Program Elements • Needs Assessment • Survey • Mail, e-mail, in person, etc. • Who works with what where • Records review • Training - identify needs such as emergency and spill response, waste handling, hazard identification, and exposure control • Medical Surveillance 1-0200

  14. Program Elements • Institutional Biosafety Committee (IBC) • Members • Principal Investigators / Microbiologists • Occupational Physician • Biosafety Specialist • EHS Team / Emergency Response • Other Specialists 1-0200

  15. Program Elements • Institutional Biosafety Committee (IBC) • Procedures • Risk Assessment • Pathogens • rDNA • Select agents • Human blood and tissues • Other hazards 1-0200

  16. Program Elements • Institutional Biosafety Committee (IBC) • Coordinate with other committees • Animal Care and Use • Human Subjects Review • Radiation Safety • Laboratory Safety 1-0200

  17. Program Elements • Tools • Biological Use Authorization Form • Researcher information • Agents/materials used • rDNA information • Work description • Others… • Renewal period - e.g., 2/3 yrs 1-0200

  18. Program Elements • Tools • Database • Track BUAs • Agents/materials • Researchers • Laboratories • Others 1-0200

  19. 1-0200

  20. Program Elements • Tools • Develop standard procedures, such as: • Standard microbiological practices • Sample receipt and handling • Decontamination • Waste handling • Packaging and shipment 1-0200

  21. Program Elements • Tools • More standard procedures... • Biological safety cabinet use and maintenance • Spill and emergency response • Ventilation requirements • Sharps • PPE 1-0200

  22. 1-0200

  23. Program Elements • Go! • Beta test • Roll out to all identified on database • Communicate expectations • Train on procedures • Offer extensive help • Resources - person to answer questions, web resources, web site, forms, etc. 1-0200

  24. Program Elements • Go! • More on training • introductory laboratory biosafety • annual BBP and biosafety refresher • IBC procedures • specialized situations - new lab work • emergency response 1-0200

  25. Responsibilities Researchers IBC Biosafety Officer Processes Medical surveillance Training Safety procedures Spill response Emergency response Periodic program review Program Management 1-0200

  26. Program Management • Elements • Audits and inspections • Quarterly reports to IBC • Ongoing communication with other committees • Regulatory compliance - BBP, select agents, medical waste, rDNA, BMBL 1-0200

  27. Summary • Evaluate what you need in a “program” • Roll out the program in a logical sequence • Ensure consistent program management 1-0200

  28. Useful Resources • http://www.cdc.gov/od/ohs/default.htm (CDC OHS) • http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm (BMBL) • http://www.cdc.gov/od/ohs/lrsat.htm (LR/SAT) • http://www4.od.nih.gov/oba/rdna.htm • http://www.absa.org/ • http://www.hhmi.org/ • Biological Safety, Principles and Practices. 3rd edition. Ed. by D. O.Fleming and D. L. Hunt. ASM Press. 1-0200

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