FORMER CONTROL OF BIOHAZARDS IN THE CLINICAL & RESEARCH LABORATORY
Educational Objectives.
Dr. Richard Gilpin RBP CBSP SM(NRCM).
Title: Biosafety Sources.
Objectives: Upon completion of this activity, participants should be able to:
Interpret and apply regulations associated with animal pathogens.
Discuss the difference between the American Association for Laboratory Animal Science and the Association for Assessment and Accreditation of Laboratory Animal Care.
Utilize biosafety web links and publications provided by the ABSA International and the American Society for Microbiology (Biological Safety Principles and Practices).
List biosafety-related publications such as: Hot Zone, Biohazard, The Demon in the Freezer, and Outbreak (Cases in Real-World Microbiology).
Discuss the impact of Public law 107-56 (USA Patriot Act) and the Public Health Security and Bioterrorism Response Act on research.
Discuss the Bureau of Industry and Security Export Control program.
Summarize the CDC National Laboratory Response Network.
Review the BMBL-6 and WHO-4 Laboratory Biosafety Manuals.
Review HHS 42 CFR Parts 72, 73 and 1003 Possession, Use and Transfer of Select Agents and Toxins.
Review the USDA 7 CFR Part 331 and CFR 9 CFR Part 121 Agricultural Bioterrorism Protection Act.
Describe the impact of the Citizenship and Immigration Services regulations on microbiological research.
Plan a Department of Defense Biological Defense Safety Program for your institution.
Identify federal and non-profit associations that provide regulations and guidelines for hospital biosafety such as CDC and Joint Commission.
Interpret and apply OSHA law, standards, and directives as they relate to biohazards.
Demonstrate familiarity with agencies & their relationship with biosafety –
WHO, CDC, CDC-NIOSH, CDC-ATSDR, NIH, OSHA, AAALAC, DOT PHMSA, IATA, ICAO, DOD, EPA, Energy, FBI, USDA, & FDA.
Provide and interpret biosafety resource and reference information from the National Institutes of Health and the Public Health Agency of Canada.
List microbiology and biosafety references such as: Lang Series, Jawetz, Melnick & Adelberg’s Medical Microbiology,
Medical Center Occupational Health and Safety, National Academies Guide for the Care & Use of Laboratory Animals,
& Occupational Health and Safety in the Care and Use of Research Animals.
Employ uniform biological material transfer agreements.
Recommend practices for personnel preparing cytotoxic drugs.
Recommend practices for sorting unfixed cells.
Identify and register research with recombinant or synthetic NA, human tissue, pathogens, select agents and toxins, and carcinogenic, highly toxic and hazardous chemicals.
Develop a research tracking database.
Evaluate laboratory survey field checklists.
Discuss COB Abbreviations.
Discuss Organization Acronyms, CDC Public Health Laboratories Abbreviations, Diskgen Desktop Genetics Glossary,
Glossary of Molecular Biotechnology Terms, Glossary of Commonly Used Terms in Human Subject Protection,
& Glossary of Commonly Used Terms in Gene Therapy & Immunotherapy for Cancer.
Title: Airborne Dissemination of Biohazards.
Objectives: Upon completion of this activity, participants should be able to:
Review the discovery of microbial pathogens and parallel reports of laboratory acquired infection.
Review published laboratory acquired infections survey data.
Become aware of laboratory procedures that produce droplets and how to reduce them.
Identify environmental variables that influence microbial survival.
Plan aerosol experiments to demonstrate sampling methods.
Title: Facility Design.
Objectives: Upon completion of this activity, participants should be able to:
Review the role of secondary barriers for prevention of laboratory acquired infection.
Describe the differences between facilities designed for different levels of containment.
Become familiar with parameters to be audited in a maximum containment facility.
Learn the design specifications of containment facilities.
Discuss the costs involved when renovating or building containment facilities.
Be able to find documents describing the design of biological research facilities.
Title: Biosafety Cabinets.
Objectives: Upon completion of this activity, participants should be able to:
Review the role of primary barriers for prevention of laboratory acquired infection.
Describe how HEPA/ULPA filters trap particles.
Identify the classes and types of biosafety cabinets and their applications.
Review NSF 49 Annex 1 guidelines.
Review the activities of NSF international.
Become familiar with performance tests at NSF and in the field.
Describe when BSCs should be certified.
Title: Risk Management Principles.
Objectives: Upon completion of this activity, participants should be able to:
Describe the types of host/parasite relationships.
Summarize pathogen virulence factors and modes of action.
Discuss Koch’s Postulates.
Classify disease causing organisms.
Perform risk analysis of microbial procedures.
Explain natural host defense mechanisms.
Sketch disease modes of transmission.
Develop, evaluate, and document exposure control procedures for biohazardous agents and materials.
Understand and apply monitoring techniques and equipment to determine effectiveness of exposure control measures and to investigate environmental problems.
Demonstrate knowledge of personal risk factors associated with microbial exposure.
Demonstrate familiarity with routes of exposure, modes of transmission, and other criteria that determine the hazard category of a microorganism.
Assess the risk to the community from various work environments where infectious agents or sensitizing materials may be present.
Understand factors that may affect susceptibility, resistance, or consequences of infection.
Discuss differences between screening and surveillance and the principles of surveillance.
Prepare a medical surveillance program for your institution.
Predict the types of issues encountered if the medical surveillance provider is an outside medical clinic.
List federally mandated surveillance programs and the limitations of early biological effect markers.
Discuss biosafety aspects of COVID-19 disease coronavirus , Zika virus, and Ebola virus.
Title: Bloodborne Pathogens Standard.
Objectives: Upon completion of this activity, participants should be able to:
Review the OSHA 29 CFR 1910.1030 standard and the revised needlestick and other sharps injury regulation.
Interpret frequent OSHA bloodborne pathogen-related citations.
Plan a program for management of bloodborne pathogen exposures.
Assure documentation of worker exposure to biohazardous materials and preparation of an incident report.
Report the modes of transmission and microorganisms involved in occupational exposure to bloodborne pathogens.
Identify post exposure prophylaxis and/or treatment for HIV, HBV and HCV.
Provide recommendations for prevention and control of HCV infection.
Discuss the OSHA 300 reporting regulations.
Title: Handling Infectious Waste.
Objectives: Upon completion of this activity, participants should be able to:
Explain the EPA Infectious waste guidelines and the EPA medical waste tracking act.
Review commercial, industrial, medical and education generators of infectious waste.
Plan procedures for infectious waste segregation, transport, packaging and storage.
Summarize current best practices for decontamination of pathological, clinical and research infectious waste.
Propose vendor sources for infectious waste and sharps disposal containers.
Interpret and apply guidelines and state regulations relating to treatment and disposal of infectious and medical waste.
Develop and implement an infectious-medical waste management program.
Title: Biosafety Practices & Techniques.
Objectives: Upon completion of this activity, participants should be able to:
Select and understand use of personal protective equipment.
Select and understand use of respiratory protection equipment.
Develop comprehensive emergency response plan for biohazard areas.
Identify sources of biosafety training videos and programs.
Institute, evaluate, and document biosafety training.
Review architectural and engineering plans and advise on biosafety issues.
Review documented laboratory accidents reported in the news media.
Analyze microbiological practices involving access control, hygienic practices, gloves, eye protection, nose and mouth protection, gowns,
head and foot covers, standard precautions, control of aerosols, housekeeping practices, emergency eyewash/shower systems.
Discuss start up practices before using a biosafety cabinet.
Develop safety practices for sorting unfixed cells.
Recommend emergency procedures for spills inside and outside containment equipment.
Organize an laboratory emergency response plan based on the National Safety Council Emergency Response Plan.
List laboratory-related regulations.
Discuss items often overlooked in the laboratory.
Evaluate relevant codes and standards applicable to research laboratories.
Title: Recombinant or Synthetic NA Guidelines and IBC Programs.
Objectives: Upon completion of this activity, participants should be able to:
Discuss the current NIH Guidelines.
Evaluate the risks associated with recombinant or synthetic NA technology.
Interpret the definitions of recombinant or synthetic NA and apply the NIH Guidelines for research involving recombinant or synthetic NA molecules.
Discuss the roles of the Office of Science Policy, the National Science Advisory Board for Biosecurity,
Institutional Biosafety Committees, Biosafety Officers, and Principal Investigators.
Review the connections between IBCs, Institutional Review Boards, and Institutional Animal Care and Use Committees.
Describe the NIH Guideline reference categories.
Examine the FDA Center for Biologics Evaluation and Research and the Environmental Protection Agency role in recombinant or synthetic NA research.
List molecular biology education and training materials.
Interpret and apply guidelines that classify biohazardous agents according to risk.
Discuss genomic and plasmid isolation and purification methods and the differences between Northern, Southern and Western blots.
Examine prokaryotic cloning vehicles and eukaryotic cell transformation methods.
Illustrate gene transfer vehicles used in gene transfer clinical trials.
Summarize major vectors used in recombinant or synthetic NA research.
List non-viral based gene transfer systems.
Review ex-vivo and in-vivo somatic cell transfer.
Interpret large DNA fragment cloning libraries including YACs, BACs and PACs.
Review documents needed to implement and manage an IBC program.
Review molecular biotechnology terms.
Title: Decontamination & Disinfection.
Objectives: Upon completion of this activity, participants should be able to:
Describe the differences between sterilization, decontamination, and disinfection and the applicability and means of monitoring each of these processes.
Summarize the population dynamics of microbial inactivation and the factors that affect microbial destruction or inactivation.
List the properties of an ideal disinfectant.
Review the gases used for chemical disinfection or sterilization (vapor phase hydrogen peroxide, chlorine dioxide gas, formaldehyde gas,
hydrogen peroxide vapor plasma, ozone, low temperature steam formaldehyde and peracetic acid vapor.
Review the liquids used for chemical disinfection or sterilization (halogens, quaternary ammonium salts, phenolics, aldehydes, alcohols,
heavy metals, iodophors, amphoteric surfactants, organic sulfur compounds, peracetic acid, formic acid and sodium hydroxide.
Evaluate activity levels of germicides for disinfection of surfaces.
Recognize the heat processes for physical decontamination and sterilization (dry heat and moist heat).
Discuss the differences between chemical indicators and biological sterilization indicators.
Propose an autoclave quality assurance program for decontamination of waste.
Demonstrate knowledge of use, applicability, and potential hazards (explosive, flammable, corrosive, carcinogenic, and irritating)
associated with various disinfectants and sterilants.
Discuss the use chemicals, steam, dry heat, irradiation, filtration, ultraviolet (UV) sources, gases, or other agents to kill or inactivate microorganisms.
Predict the shortcomings of germicidal ultraviolet light decontamination of surfaces.
Apply equipment and chemical methods for decontamination of rooms.
Review filtration processes for physical sterilization of liquids.
Summarize the procedures and processes for inactivation of Bacillus spp. Spores.
Describe the procedures for inactivation and safety containment of biological toxins.
Title: Biological Packaging & Shipping.
Objectives: Upon completion of this activity, participants should be able to:
Review the definitions and classes of dangerous goods (hazardous materials).
Discuss US Transportation Security Administration and Public Laws.
List international and US regulations applicable to shipment of dangerous goods.
Review the United Nations regulations promulgated by the International Civil Aviation Organization (ICAO) basis of the International Air Transport Association (IATA) regulations.
Contrast the training requirement differences of the US Department of Transportation (DOT) and IATA.
Locate DOT shipping information on the internet.
Describe the dangerous goods carry on or checked baggage rules.
Discuss Dangerous Goods Excepted Quantities Declaration for carry on or checked baggage.
Review in detail Class 6, Division 6.1 Toxic Substances and Class 6, Division 6.2 Infectious Substances.
Review the Category A table of infectious agents.
Identify the classification of biological products, genetically modified microorganisms and organisms and biological substances exempted from shipping regulations.
Utilize the Infectious Substance Category A Packing Instruction 620 to ship infectious substances.
Apply the supplied template to construct a Dangerous Goods Declaration for shipment of Infectious Substance Category A on dry ice.
Utilize the Category B Biological Substance Category B Packing Instruction 650 to ship biological substances.
Utilize the dry ice packing instruction 954 to ship dry ice.
Utilize the liquid nitrogen packaging instruction 202 to ship materials in liquid nitrogen and the exemption for dry shippers.
Apply the supplied template to construct an Air Waybill to ship non-dangerous goods on dry ice.
Discuss regulations for shipment of select agents and toxins.
Review CDC import permits and APHIS import and transport permits.
Use the Commerce Department list to determine whether an export permit is required for shipments outside the US.
List Division 6.2 container vendors and shipping companies.
Review DOT PHMSA and US Postal Service shipping regulations and their applicability when shipping by air.
Propose guidelines for transporting clinical and biological specimens from outside clinics, labs or homes to a research or clinical laboratory.
Evaluate the containment devices for transport of infected live animals.