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Biosafety at MUSC

Biosafety at MUSC. IBC website. Michael G. Schmidt, Ph.D., Chair, Biosafety Committee. Biosafety at MUSC. Learning Objectives Understand the role and responsibilities of the PI with respect to Biosafety and Animals

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Biosafety at MUSC

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  1. Biosafety at MUSC IBC website Michael G. Schmidt, Ph.D., Chair, Biosafety Committee

  2. Biosafety at MUSC • Learning Objectives • Understand the role and responsibilities of the PI with respect to Biosafety and Animals • Understand the underlying principles of biosafety as they relate to conducting safe and effective science requiring the use of biohazardous materials on campus • Be able to locate resources that will facilitate the determination of the relative biosafety risk associated with a planned experiment • Recognize the significance and need for conducting experiments at different biosafety containment levels • Understand the differences between BSL1 and BSL2

  3. Biosafety at MUSC • Learning Objectives continued: • Recognize the role each piece of Personal Protective Equipment plays in safeguarding the health and welfare of the laboratorian and community • Be familiar with the proper use of Biological Safety Cabinets (BSC) • Recognize the inherent risk with using centrifuges in the laboratory with a special emphasis on risks associated with infectious agents • Understand the significance of good laboratory housekeeping • Be able to clean up a minor biological spill within a BSC • Understand what is required of you during the bi-annual Laboratory Biological Safety Inspection

  4. Biosafety at MUSC • Learning Objectives continued: • Understand the signficance of working with biohazardous Materials specifically the role of the PI in informing the laboratorian of potential hazards in the workplace as well as the personal responsibility required of each employee and student

  5. Biosafety at MUSC • Unit 1 • The role and responsibilities of the PI with respect to Biosafety and Animals at MUSC

  6. Biosafety in Biomedical Laboratories at MUSC • The role and responsibilities of the PI with respect to Biosafety and Animals • A full-time faculty or professional staff member with an advanced degree must agree to accept responsibility for the project and serve as the PI. • Student researchers, residents, and postdoctoral fellows cannot be identified as principal investigators. • The Principal Investigator (PI) is responsible for full compliance with the federal and state regulations, NIH and CDC Guidelines, and institutional requirements for research involving biohazardous materials. • The PI is also responsible for ensuring that the reporting requirements are fulfilled and will be held accountable for any reporting lapses.

  7. Definition • Biohazard • An agent of biological origin that has the capacity to produce deleterious effects on humans, animals, plants and insects. These include microorganisms, toxins and allergens derived from those organisms; and allergens and toxins derived from insects, animals and plants.

  8. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf

  9. http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm http://www.cdc.gov/od/ohs/biosfty/bsc/bsc.htm PDF PDF Biosafety in Microbiological and Biomedical Laboratories • The role and responsibilities of the PI with respect to Biosafety and Animals • The Principal Investigator (PI) is responsible for full compliance with the federal and state regulations, NIH and CDC Guidelines, and institutional requirements for research involving biohazardous materials.

  10. Biosafety at MUSC • Questions for Unit 1 • The role and responsibilities of the PI with respect to Biosafety and Animals at MUSC

  11. Biosafety at MUSC • Unit 2 • Principles of Biosafety as they relate to the safe conduct of science requiring the use of biohazardous materials at MUSC

  12. Definition • Biohazard • An agent of biological origin that has the capacity to produce deleterious effects on humans, animals, plants and insects. These include microorganisms, toxins and allergens derived from those organisms; and allergens and toxins derived from insects, animals and plants.

  13. Biosafety in Microbiological and Biomedical Laboratories • Principles of Biosafety • Containment • The purpose of containment is to reduce or eliminate exposure of: • laboratory workers, • other persons • the environment • Safe methods for managing infectious agents in the laboratory • Environment • The location where the agent being handled, maintained or stored.

  14. Infectious Agents and the lab worker • Modes of Infection • Infections preceded by overt personal accidents, which include: • Inoculation • resulting from pricking, jabbing or cutting the skin with contaminated instruments such as: • hypodermic needles, scalpels and glassware; • from animal bites or scratches • Ingestion • resulting from mouth-pipetting, eating, drinking and smoking • Splashing into the face and eyes • Spillage and direct contact

  15. Infectious Agents and the lab worker • Infections not preceded by personal accidents: • Aerosols, droplets and fomites. • These are speculated (from Pike’s 1976 data) to be responsible for up to 82% percent of all laboratory-acquired infections. • Aerosols are a cloud of very small liquid droplets produced whenever energy is applied to a liquid, and such liquid is allowed to escape into the environment. • Centrifugation is a good source (plasmid preps)

  16. Infectious Agents and the lab worker • There are many regulations in place to forestall the problem of laboratory-acquired infections. • Responsibility for compliance with the regulations • Primarily to the Principal Investigator • Secondarily, with the laboratory staff. • In general a large number of organisms that would ordinarily be innocuous can be infective in immune compromised persons. • Therefore, additional and more stringent measures must be established by the PI in an effort to prevent the occurrence of lab-acquired infections in such individuals.

  17. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf

  18. Biosafety in Microbiological and Biomedical Laboratories • Primary containment • Protection from exposure to infectious agents, is provided by both good microbiological technique and the use of appropriate safety equipment. • Secondarycontainment • Protection of the environment external to the laboratory from exposure to infectious materials • Facility design • Operational practices

  19. Biosafety in Microbiological and Biomedical Laboratories • Three elements of containment include: • Laboratory practice and technique, • Safety equipment • Bunsen burners vs. Bactincinerators • Cages and other barriers • Facility design • The risk assessment of the work to be done with a specific agent will determine the appropriate combination of these elements.

  20. Biosafety in Microbiological and Biomedical Laboratories • Laboratory practice and technique • Standard microbiological practices and techniques • Persons working with infectious agents or potentially infected materials must be aware of potential hazards, and must be trained and proficient in the practices and techniques required for handling such material safely. • The director or person in charge of the laboratory is responsible for providing or arranging for appropriate training of personnel.

  21. Biosafety in Microbiological and Biomedical Laboratories • A scientist trained and knowledgeable in appropriate laboratory techniques, safety procedures, and hazards associated with handling infectious agents must direct laboratory activities. • Each laboratory should develop or adopt a biosafety or operations manual which identifies the hazards that will or may be encountered, and which specifies practices and procedures designed to minimize or eliminate risks. • All personnel should be advised of special hazards and should be required to read and to follow the required practices and procedures. • Each individual in the laboratory should acknowledge that they have been advised and briefed as to the laboratory’s plan and to the risks that they will be exposed. • There is no such thing as zero risk!

  22. Biosafety at MUSC • Questions for Unit 2 • Principles of Biosafety as they relate to the safe conduct of science requiring the use of biohazardous materials at MUSC

  23. Biosafety at MUSC • Unit 3 • How to determine the relative biosafety risk associated with a planned experiment

  24. Laboratory Containment Levels for Biological Research Involving Potential Biohazards • Questions to Ask ? • Hazard Levels • MSDS for Microbes • Standard Microbiological Practices • Special Practices • Containment Equipment http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/

  25. Laboratory Containment Levels for Biological Research Involving Potential Biohazards • Questions to Ask ? • Hazard Levels • MSDS for Microbes http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/

  26. Laboratory Containment Levels for Biological Research Involving Potential Biohazards • Questions to Ask ? • Hazard Levels • MSDS for Microbes • Issue Aerosol • 150 pfu is infectious intra-nasally • Incubation • 1-10 days • Communicability • Yes http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/

  27. Laboratory Containment Levels for Biological Research Involving Potential Biohazards • Questions to Ask ? • Hazard Levels • Disinfectants • Bleach • Physical Inactivation • Survival outside host • Type 3 survival 10 days on paper • Type 2 survived 3-8 weeks on environmental surfaces at room temperature. http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/

  28. Laboratory Containment Levels for Biological Research Involving Potential Biohazards • Questions to Ask ? • Hazard Levels • 10 case of lab infections • Special Hazards • Contact with feces from infected animals • Spills • Disposal http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/

  29. Laboratory Containment Levels for Biological Research Involving Potential Biohazards • Questions to Ask ? • Hazard Levels • MSDS for Microbes • Standard Microbiological Practices • Special Practices • Containment Equipment http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/

  30. Laboratory Containment Levels for Biological Research Involving Potential Biohazards • Infectious Agents • Work may only be conducted with prior approval of the IBC regardless of the safety classification of the agent • You must follow the requirements as specified in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories Manual • Containment requirements may be subject to modification by the IBC

  31. Laboratory Containment Levels for Biological Research Involving Potential Biohazards • Define the risk • Infectious Agents List • Experimental Protocol • How big ? • Aerosols ? • Animals ?

  32. Laboratory Containment Levels for Biological Research Involving Potential Biohazards • SECTION II - Principles of Biosafety • Recommended Biosafety Levels for Infectious Agents in the Laboratory • Summary of Recommended Biosafety Levels for Activities in Which Experimentally or Naturally Infected Vertebrate Animals Are Used PDF http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s2.htm

  33. Laboratory Containment Levels for Biological Research Involving Potential Biohazards • Section III Laboratory- Biosafety Level Criteria • BSL 1, BSL 2, BSL 3, BSL 4 • Comparison of Biological Safety Cabinets • Section IV-Vertebrate Animal Biosafety Level Criteria • ABSL 1, • ABSL 2, • ABSL 3, • ABSL 4 http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s3.htm http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s4.htm

  34. Laboratory Containment Levels for Biological Research Involving Potential Biohazards • SECTION V - Risk Assessment • SECTION VI- Recommended Biosafety Levels For Infectious Agents and Infected Animals • Section VII- Agent Summary Statements http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s5.htm http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s6.htm http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s7.htm

  35. Recombinant DNA, Gene Therapy and Transgenics Guidelines for Research Involving Recombinant DNA Molecules Or in PDF at this site • Scope • Safety • Experiments Governed • Roles and Responsibilities http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Gdlnes_lnk_2002z.pdf

  36. Recombinant DNA, Gene Therapy and Transgenics Guidelines for Research Involving Recombinant DNA Molecules • Classification of Human Etiologic Agents on the Basis of Hazard • Appendix B-I. Risk Group 1 (RG1) Agents • Appendix B-II. Risk Group 2 (RG2) Agents • Appendix B-III. Risk Group 3 (RG3) Agents • Appendix B-IV. Risk Group 4 (RG4) Agents

  37. Recombinant DNA, Gene Therapy and Transgenics Guidelines for Research Involving Recombinant DNA Molecules • Physical and Biological Containment for Recombinant DNA Research Involving Animals • Appendix Q-I. General Considerations • Appendix Q-I-A. Containment Levels • Appendix Q-I-B. Disposal of Animals (BL1-N through BL4-N) • Appendix Q-II. Physical and Biological Containment Levels • Appendix Q-II-A. Biosafety Level 1 - Animals (BL1-N) • Appendix Q-II-B. Biosafety Level 2 - Animals (BL2-N) • Appendix Q-II-C. Biosafety Level 3 - Animals (BL3-N) • Appendix Q-II-D. Biosafety Level 4 - Animals (BL4-N) • Appendix Q-III. Footnotes and References for Appendix Q http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm

  38. Recombinant DNA, Gene Therapy and Transgenics Guidelines for Research Involving Recombinant DNA Molecules • What’s Exempt? • See section III F (page 20 NIH Guide (April 02)) • Those that are not in organisms or viruses • Those that consist entirely of DNA segments from a single non-chromosomal or viral DNA source, though one or more of the segments may be synthetic • Those that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means. • Those that consist entirely of DNA from a eukaryotic host including its indigenous chloroplasts, mitochondria or plasmids (excluding viruses) when propagated in that host. • Bottom line… PCR and gel running..

  39. Biosafety at MUSC • Questions Unit 3 • How to determine the relative biosafety risk associated with a planned experiment

  40. Biosafety at MUSC • Unit 4 • Specific Requirements for Biosafety Levels 1 to 3 • PPE • Biological Safety Cabinets (BSCs) • Risks associated with centrifugation and proper protocols

  41. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf

  42. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf

  43. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf

  44. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf

  45. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf For more information: http://www.washup.org

  46. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf

  47. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf

  48. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf

  49. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf

  50. http://www.cdc.gov/od/ohs/pdffiles/ Module%202%20-%20Biosafety.pdf

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