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Module 3 biosafety principles & microbiologycal risk group 21 1-18
- 1. Biosafety Principles & Microbiological Risk group 2018
- 2. Principle of Biosafety Biosafety Levels 1-4 describe combinations of: – Laboratory Practices and Techniques – Safety Equipment including PPE (Primary Barriers) – Laboratory Facilities (Secondary Barriers) Biosafety Levels 1-4 Provide – Increasing levels of personnel and environmental protection – Guidelines for working safely in laboratories using biological agents
- 3. Principle of containment • Used to describe safe methods for managing infectious agent in the laboratory environment where they are being handle or maintained.
- 4. Elements of containment • Primary containment - Protection of personnel and the immediate laboratory environment - Use of laboratory practices, technique, safety equipment • Secondary containment - Protection of environment external to immediate laboratory
- 5. Selection of containment measures ( the biosafety level) • Knowledge of containment mechanisms( theKnowledge of containment mechanisms( the laboratory)laboratory) - understanding of the mechanisms of- understanding of the mechanisms of containment and measures used to controlcontainment and measures used to control the potential for escape, transmission andthe potential for escape, transmission and exposureexposure • Match containment to riskMatch containment to risk • Source of assistanceSource of assistance - National/ international guidelines and- National/ international guidelines and professional biosafety personnelprofessional biosafety personnel
- 6. Biosafety Level 1 (BSL-1) • Suitable for work involving well-characterized agents not known to consistently cause disease in immuno competent adult humans • Minimal potential hazard to laboratory personnel and the environment • Laboratories are not necessarily separated from the general traffic patterns in the building e. g biological lab in secondary school or college working with e coli
- 7. Biosafety Level 2 (BSL-2) • Builds upon BSL-1 • BSL-2 is suitable for working involving agents that pose moderate hazards to personnel and the environment • Laboratory personnel have specific training in handling pathogenic agents • Personnel are supervised by scientists competent in handling infectious agents an associated procedures • Access to the laboratory is restricted when work is being conducted
- 8. Biosafety Level 2 ( BSL-2) • All procedures in which infectious aerosols or splashes may be created are conducted in biological safety cabinets (BSCs) or other physical containment equipment • Mandatory warning Sign - Designate Biosafety Level - Special Entry Procedures - Immunizations - PPE - Contact Information • E. g Hospital Lab, Universities working with Streptococci
- 9. BSL 2 (WHO 3rd Ed)
- 10. Biosafety Level 3 (BSL-3) • Is applicable to clinical, diagnostic, teaching, research or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through inhalation route exposure. • Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents • Must be supervised by scientists competent in handling infectious agents and associated procedures
- 11. Biosafety Level 3 ( BSL-3) • Biosafety Level-2 plus all procedures involving the manipulation of infectious materials must be conducted within BSCs, or other physical • Personnel wear additional appropriate personal protection equipment including respiratory protection as determined by risk assessment • A BSL-3 laboratory has special engineering and design features - Directional air flow
- 13. Biosafety Level 4 (BSL-4) • Required for working with dangerous and exotic agents that pose a high individual risk of life-threatening disease, aerosol transmission, or related agent with unknown risk of transmission • Agents with a close or identical antigenic relationship to agents requiring BSL-4 containment must be handled at this level until sufficient data are obtained either to confirm continued work at this level, or re-designate the level • Laboratory staff must have specific and thorough training in handling extremely hazardous
- 14. Biosafety Level 4 (BSL-4) • Laboratory staff must understand the primary and secondary containment functions of standard and special practices, containment equipment and laboratory design characteristics • All laboratory staff and supervisors must be competent in handling agents and procedures requiring BSL-4 containment • Access to the laboratory is controlled by the laboratory supervisors in accordance with institutional policies • Two types of laboratory providing absolute separation of the worker from the infectious agents (suit Laboratory & cabinet laboratory)
- 15. Biosafety Level 4 (BSL-4)
- 16. Microbiological Practices Classification of Risk Group Agent
- 17. WHO Classification of infective microorganisms by risk group Risk Group 1 (no or low individual and community risk) Risk Group 2 (moderate individual risk, low community risk) Risk Group 3 (high individual risk, low community risk) Risk Group 4 (high individual and community risk)
- 18. Risk Group 1 No or low individual and community risk - A microorganism that is unlikely to cause human diseases or animal disease e.g. E.coli K12 Bacillus subtilis, Staphylococcus epidermidis
- 19. Risk Group 2 Moderate individual risk, low community risk Pathogen causes human or animal disease but it unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment May cause serious infection but effective treatments and preventive measures are available Risk of spread it limited e.g. Herpes viruses , VSV …… Escherichia coli Staphylococcus aureus
- 20. Risk Group 3 High individual risk, low community risk Pathogen usually cause serious human or animal disease but does not ordinarily spread to others Effective treatment and preventive measures are available E.g Mycobacterium tuberculosis, Burkholderia pseudomallei Rickettsia spp.
- 21. Risk Group 4 High individual and community risk A pathogen cause serious human or animal disease; readily transmitted from one individual to another Effective treatment and preventive measures are usually not available Eg: Ebola, Marburg, and Nipah viruses
- 22. Risk groups & biosafety levels BSL Laboratory type Laboratory practices Safety equipment 1 Basic teaching, research Good microbiological techniques None Open bench work 2 Primary health services; diagnostic services, research Good microbiological techniques, protective clothing, biohazard sign Open bench PLUS biological safety cabinet for potential aerosols 3 Special diagnostic services, research As BSL 2 PLUS special clothing, controlled access, directional airflow Biological safety cabinet and/or other primary devices for all activities 4 Dangerous pathogen units As BSL 3 PLUS airlock entry, shower exit, special waste Class III biological safety cabinet, positive pressure suits, double ended autoclave (through the wall), filtered air
- 23. Risk groups HIV 2 or 3? Burkholderia pseudomallei 2 or 3? Mycobacterium tuberculosis 2 or 3? Hantavirus 2 or 3? Rabies virus 2 or 3? SARS virus 3 or 4?
- 24. Factors to consider in Classification Pathogenicity of the agent Modes of transmission and host range of organism Local availability of preventive measures Local availability of effective treatment
- 25. In summary There is no internationally accepted list of microorganisms classified according to risk groups - Different microorganisms may pose different risks in different countries. WHO recommends each country (region) to draw up a national (region) classification of microorganisms by risk group The choice of biosafety level and practices should be the result of a comprehensive risk assessment
- 26. Thank you for your attention
Notas do Editor
- To know a little bit about biosafety principle & that are risk group of Mibrobiology
- The goal of preventing injuries and diseases from occurring among students, scientists, laboratory staff and the community
- The term containment describes safe methods for managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure to potentially hazardous agents. Exposure could involve not only laboratory workers but also other individuals working close by and the outside environment.
- Element containment Primary containment Is the protection of personnel and the immediate laboratory environment from exposure to infectious agents and also provided by both good microbiological technique and the use of appropriate safety equipment. For example, produce vaccines may provide an increased level of personal protection. For the secondary containment Is the protection of the environment external to the laboratory from exposure to infectious materials So the facility design, operational practices. Ventilation systems, controlled access, airlocks, and other facility design features must be part of any biosafety program.
- Knowledge of agent characteristics - virulence and pathogenicity - Experimental procedures and manipulations that influence escape, transmission and exposure Risk assessment to evaluation of hazards and the potential for laboratory-associated disease Sources of assistance National/international guidelines and professional biosafety personnel
- Level 1 for agents that are “defined and characterized strains of viable microorganisms not known to consistently cause disease in healthy adult humans.”B. subtilis, E. coli K12, S. cervasiae Containment relies on “standard microbiological practices, no special…barriers other than a sink for hand washing.”
- Level 2 for the “broad spectrum of indigenous moderate-risk agents that are present in the community and associated with disease of varying severity.” S. aureus, B. anthracis, HIV, Hep B Containment relies primarily on “good microbiological technique…” provided the potential for producing splashes and aerosols is low. Primary hazard is by accidental percutaneous or mucous membrane exposure. Careful with sharps!!!
- This moderate-risk agents that pose a danger if accidentally inhaled, swallowed or exposed to the skin. Safety measures include limited access, biohazard warning signs, sharps precautions, class I or II BSCs The use of PPE such as gloves and eyewear as well as hand washing sinks and waste decontamination facilities such as an autoclave.
- BSL-3 laboratories are used to study agents that work is done with indigenous or exotic agents with a potential for respiratory transmission, and which may cause serious and potentially lethal infection Laboratory personnel must receive specific training and equipment in handling pathogenic agents. Supervision by a competent scientist who is experienced in working with these agents.
- Biosafety Level 3, more emphasis is placed on primary and secondary barriers to protect personnel in this areas All laboratory manipulations should be performed in a BSC Personnel wearing appropriate personal protective clothing Secondary barriers for this level include controlled access to the laboratory and ventilation requirements to minimize the release of infectious aerosols from the laboratory Biosafety Level 3
- Biosafety Level 4 should be under the control of national or other appropriate health authorities. Required for working with dangerous and exotic agents that pose a high individual risk of aerosol transmitted laboratory infections and life threatening disease. Which there is no available vaccine or therapy Agents with a close or identical antigenic relationship to Biosafety Level 4 agents also should be handled at this level When sufficient data are obtained, work with these agents may continue at this level or at a lower level The laboratory worker's complete isolation from aerosolized infectious materials is accomplished primarily by working in a Class III BSC or in a full-body, air-supplied positive-pressure personnel suit
- Personnel must receive specialized training in handling extremely dangerous infectious agents, containment equipment and functions All laboratory staff and supervisors must be competent in handling agents and procedures requiring Access to the laboratory is controlled by the laboratory supervisors in accordance with institutional policies Two types of laboratory providing absolute separation of the worker from the infectious agents
- The World Health Organization (WHO) developed a Risk Group classification of infective microorganisms handled in laboratories that emphasizes the importance of assessing both individual and community risks. The Risk Group classification describes four risk groups 1, 2, 3 and 4
- A pathogen that can cause human or animal disease but is unlikely to be serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventative measures are available and the risk of spread of infection is limited.
- Pathogenic, cause serious disease Effective treatment and preventive measures usually available Little person-to-person spread
- pathogenic agent Readily transmittable direct, indirect Effective treatment and preventive measures not usually available
- influenced by existing levels of immunity in the local population and movement of the host population, presence of appropriate vectors and standards of environmental hygiene. - prophylaxis by immunization or administration of antisera (passive immunization) - sanitary measures, e.g., food and water hygiene control of animal reservoirs or arthropod vectors Local availability of effective treatment - passive immunization, pot-exposure vaccination and use of antimicrobials, antivirals and chemotherapeutic agents - the possibility of the emergence of drug-resistant strains