Biosafety and Biocontainment - San Pedro College PDF

SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS Biosafety and 1. Biocontainment JOHN MARKE B. BERNARDO Instructor  L ea r ning O ut come s At the end of the lecture, the learners are able to: 1. di...

SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS Biosafety and 1. Biocontainment JOHN MARKE B. BERNARDO Instructor  L ea r ning O ut come s At the end of the lecture, the learners are able to: 1. discuss the principles of biosafety; 2. describe the purpose and fundamental elements of containment; 3. describe each biosafety level and discuss the corresponding criteria; 4. highlight the recombinant DNA biosafety considerations. SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  Is the laboratory a dangerous place? SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  H az a r ds ev er ywh er e ! SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS Emerging and re-emerging infections in the Philippines 2020 - Guess what? 2019 - Polio 2018 - Measles 2017 - Measles 2016 – Zika 2015 – MERSCoV, Ebola Reston 2014 – Measles, MERSCoV, Henipavirus 2013 – Pertussis, Measles 2012 – Leptospirosis 2011 – Chikungunya 2010 – Dengue 2009 – Pandemic A H1N1 SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B iologic a l Ag ent s Any microbiological entity, cellular or non-cellular, naturally occurring or engineered, capable of replication or of transferring genetic material that may be able to provoke infection, allergy, toxicity, or other adverse effects in humans, animals, or plants SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B iologic a l Ag ent s Microorganisms: Bacteria, viruses, fungi, parasites, prions, and protozoa Toxins: Produced by biological agents Genetically modified microorganisms: Created through genetic engineering Cell cultures: Derived from humans, animals, or insects Products of biological agents: Such as animal dander, pollen, urine, saliva, or sap Animals, arthropods, and plants: Used in research SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B iologic a l M at e r ia l Any material comprised of, containing, or that may contain biological agents and/or their harmful products, such as toxins and allergens. Examples: 1. Blood 2. Tissue 3. Proteins 4. Bacteria, viruses and fungi 5. Toxins SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B ioha z ar d Potential source of harm caused by biological materials. Viruses, such as Coronavirus (COVID-19) and Japanese encephalitis. Toxins from biological sources. Spores. Fungi. Pathogenic micro-organisms. Bio-active substances. SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS Biosafety and Biosecurity SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  L ab ora t or y B ios af e ty Containment principles, technologies, and implemented to practices unintentional pathogens and toxins, or their unintentional prevent exposure to release. SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  L ab ora t or y B ios af e ty PURPOSE Protect users Protect those outside the laboratory Protect the environment SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  L ab ora t or y B ios ec ur it y Institutional and personal security measures designed to prevent the loss, theft, misuse, diversion, or intentional release of pathogens and toxins SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  BIOSAFETY Protecting people from bad bugs. BIOSECURITY Protecting bad bugs from bad SAN PEDRO COLLEGE people. SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  Identify if this is a Biosafety or Biosecurity issue/measure. 1. Recapping of needles 2. Lab technologist is a member of a terrorist group 3. Lab personnel not provided with PPEs 4. Disgruntled staff 5. Work overload 6. Wastes from the lab are not segregated 7. Lack of staff training 8. Staff with a huge debt SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  P ri nci ple s of Bi osaf e t y 1. Practice and procedures Standard practices Special practices and considerations 2. Safety equipment 3. Facility design and construction 4. Increasing levels of protection SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  P ri nci ple s of Bi osaf e t y (1) Standard Microbiological Practices Most important concept/strict adherence Aware of potential hazard Trained and proficient in techniques Supervisors responsible for: Appropriate laboratory facilities Personnel and training Special practices and precautions Occupational health programs SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B ioc ont ai nmen t Physical containment of highly pathogenic organisms or agents usually by isolation in environmentally and biologically secure cabinets or rooms to prevent accidental infection of workers or release into the surrounding community, especially during scientific research Primary or Secondary SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  P ri mar y SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  P ri mar y & S e cond ar y Cont a inme nt Primary Barriers (control hazard at the source) - BSC - Animal Cage Secondary Barriers (structure surrounding primary barrier) - Sealed perimeter (walls, floors, ceiling) SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  P ri nci ple s of Bi osaf e t y (2) Safety Equipment Minimize exposure to hazard Primary containment barrier Engineering controls/equipment Personal protective equipment (PPE) Gloves, gowns, respirator, face shield, shoes SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  P ri nci ple s of Bi osaf e t y (3) Facility Design and Construction Secondary barrier/engineering controls Contributes to worker protection Protects outside the laboratory Environment and neighborhood Ex.Building and lab design, ventilation, autoclaves, cage wash facilities. SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  P ri nci ple s of Bi osaf e t y (4) Increasing Levels of Protection Biosafety Levels 1-4 (BSL) Increasing levels of employee and environmental protection Animal Biosafety Levels 1- 4 (ABSL) and Agricultural (BSL-3-Ag) Laboratory animal facilities Plant, GMO facilities Animal models that support research SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B iosa f et y Le ve l s Combination of laboratory practicesand procedures, safety equipment (primary barriers)and laboratory facilities (secondary barriers) Also referred to as Containment Levels SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B SL 1 Wellcharacterized, non-pathogenic organisms or agents Open bench - no containment Usegood laboratory practices, waste disposal, and aseptic techniques SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B SL 1 SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B SL 2 Builds upon BSL-1 Agents of moderate hazard to personnel or environment Examples: most non-respiratory, non lethal, agents Basic lab, but restricted access Containment during certain processes (i.e. aerosols, large volumes, etc.) Autoclave and Biological Safety Cabinet desired Use good laboratory practices, waste disposal, and aseptic techniques SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B SL 2 Class II Auto SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B SL 2+ Used to describe laboratories where work with microorganisms is conducted in a BSL-2 laboratory with biosafety practices and procedures typically found at BSL-3 NOT a recognized containment level in biosafety guidance documents Allows for research work with microorganisms including viral vectors to take place in an environment where the safety practices are enhanced over and above the practices required at BSL-2 May not always be appropriate for pathogens that are infectious via the inhalation route SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B SL 3 High containment Agents of high hazard to personnel or environment Agents that may cause serious or potentially lethal disease through the inhalation route of exposure Clinical, diagnostic, teaching, research, or production facilities where work is performed with indigenous or exotic agents SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B SL 3 Entry Change room ( ve) ( ve) Class II Minus pressure Auto SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  B SL 4 Maximum containment Dangerous and exotic agents that pose a high individual risk of aerosol transmitted laboratory infections Total containment, airtight labs, “submarine” doors, air pumps, water treatment, HEPA filtration, etc. Positive pressure “moonsuits” SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  R isk Gr oup s Assignment of microorganisms into groups based on: Pathogenicity of the organism Mode of transmission and host range Local availability of effective preventative measures Local availability of effective treatment Pathogen Safety Data Sheets (PSDS) SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  Risk groups correlate but DO NOT equate with Biosafety Levels! SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS L a b o r a t o ry - A c q u i re d I n f e c t i o n s are infections, either symptomatic or asymptomatic, that are acquired through laboratory or laboratory- related activities, as a result of working with infectious agents 20% due to equipment failure 80% related to human factors SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  Biosafety & Recombinant DNA technology Recombinant DNA Technology (Genetic Engineering) was first used to clone DNA segments in bacterial hosts in order to overexpress specific gene products for further studies gene therapy new vectors for gene transfer have also been used to create GMOs such as transgenic plants and animals. SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  Risk Assessments for Genetically Modified Organisms Should consider the characteristics of donor and recipient/host organisms. SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  Hazards Arising Directly from the Inserted Gene (Donor Organism) Assessment is necessary in situations where the product of the inserted gene has known biologically or pharmacologically active properties that may give rise to harm, for example: 1.Toxins 2.Cytokines 3.Hormones 4.Gene expression regulators 5.Virulence factors or enhancers 6.Oncogenic gene sequences 7.Antibiotic resistance 8.Allergens SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  Hazards Associated With the Recipient/Host Susceptibility of the host Pathogenicity of the host strain, including virulence, infectivity and toxin production Modification of the host range Recipient immune status Consequences of exposure SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS  References Biosafety in Microbiological and Biomedical Laboratories, 2009 Canadian Biosafety Standards and Guidelines, 2013 CWA 15793:2011 Global Biorisk Management Curriculum Library by Sandia National Laboratories WHO Biosafety Manual, 2019 WHO Laboratory Biosecurity Guidance, 2006 SAN PEDRO COLLEGE SCHOOL OF MEDICAL LABORATORY SCIENCE MOLECULAR BIOLOGY & DIAGNOSTICS