PRINCIPLE OF RISK MANAGEMENT FOR LABORATORY HANDLING OF DANGEROUS PATHOGENS
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1 PRINCIPLE OF RISK MANAGEMENT FOR LABORATORY HANDLING OF DANGEROUS PATHOGENS Arunee Thitithanyanont, M.D. Department of Microbiology Faculty of Science, Mahidol University (6 th Jul, mins)
2 OUTLINE Principle of biosafety Risk assessment Risk management
3 WHAT IS A BIOHAZARD? A potential hazard to humans, animals or the environment caused by a biological organism, or by material produced by such an organism Examples; Micro-organisms such as viruses, bacteria, fungi, and parasites and their toxins. Blood and body fluids, as well as tissues from humans and animals. Transformed cell lines and certain types of nucleic acids.
4 SAFETY Absence or minimization of risk Occupational safety is not the absence of accidents, but the result of taking positive action to identify accident causes and implement and maintain suitable preventive measures
5 WHAT IS BIOSAFETY? The application of knowledge, techniques and equipment to prevent personal, laboratory and environmental exposure to potentially infectious agents or biohazards.
6 SAFETY ASSESSMENT Determine hazards and evaluate risks Use all relevant available data Determine controls needed to minimise those risks Risk = Hazard x Exposure
7 RISK ASSESSMENT FOR BIOLOGICAL AGENTS Identification of hazards What are you handling? What are the potential consequences? How might you be exposed? Who else might be exposed How likely is exposure? What controls are necessary? Signs and symptoms of infection
8 WHAT ARE THE RISK FACTORS USED FOR CATEGORIZING A PATHOGEN? Pathogenicity/Virulence Route of Infection Mode of Transmission Survival in the Environment Infectious Dose Availability of Effective Preventative and Therapeutic Treatments Host Range Natural Distribution Impact of Introduction and/or Release into the Environment
9 RISK GROUPS (RG) US NIH RG1 not associated with disease in healthy adult humans or animals RG2 associated with disease which is rarely serious and for which preventative or therapeutics is often available RG3 associated with serious or lethal human disease for which preventative or therapeutics may be available RG4 associated with lethal human disease for which preventative or therapeutics are not readily available Canadian Biosafety Standards Risk Group 1 (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 risk, high community risk)
10 PATHOGEN SAFETY DATA SHEETS AND RISK ASSESSMENT Google play: Pathogen Safety Data Sheets (PSDSs) Itunes: Pathogen Safety Data Sheets (PSDSs)
11 CONTROLLING RISK Eliminate - do you have to do/use it? Substitute - is there a safer alternative? Enclose - enclosed process/ventilated enclosure Segregate - keep work away from others Procedures - safe technique, limit exposure time Train/supervise - ensure competence Information - use of signs etc PPE - personal protective equipment
12 ROUTES OF EXPOSURE Percutaneous inoculation Inhalation of aerosols Contact of mucous membranes Ingestion
13 BIOCONTAINMENT The principle of holding or being capable of holding or including within a fixed limit or area Preventing the unintentional release of biological agents through a combination of laboratory practices, containment equipment (primary barrier) and laboratory facility design (secondary barrier)
14 PRIMARY BARRIER Primary barriers contain the agent at the source Equipment/Engineering Control Biological safety cabinet, fumehood, glove box, animal housing, centrifuge, fermenter
15 SECONDARY BARRIER Secondary barrier is the structure surrounding the primary barrier Facility/Engineering Control Rooms, building Types of Facilities Basic laboratory Containment laboratory
16 BIOSAFETY LEVELS (BSL) The Four Biosafety Levels are: BSL1 - agents not known to cause disease BSL2 - agents associated with human disease BSL3 - indigenous/exotic agents associated with human disease and with potential for aerosol transmission. BSL4 - dangerous/exotic agents of life threatening nature
17 CONTAINMENT LEVELS: FACTORS TO BE CONSIDERED Aerosol Generation Quantity Concentration of the Pathogen Type of Proposed Work Shedding (specific to animals)
18 RISK MANAGEMENT: MECHANISMS TO CONTROL A HAZARD Elimination Engineering Controls Administrative Controls PPE
19
20 COMPLETE ALL DATA ENTRY IN THIS SECTION
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