biosafety levels and risk groups (1)
TRANSCRIPT
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Biosafety Levels and Risk
GroupsUnit I
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Objectives
Discuss the major characteristics of thefour Biosafety Levels.
Define Risk Group and give an example
of each.
Discuss how Risk Groups are used inconjunction with risk assessment to setBiosafety Levels.
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Biosafety Levels
Assignment of agent based on riskassessment
Depends on agent and conditions ofuse
Requires professional judgment
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Biosafety Level 1
Suitable for work involving well-characterized agents notknown to consistently cause disease inimmunocompetent adult humansminimal potential hazard to laboratory personnel and theenvironment.
laboratories are not necessarily separated from thegeneral traffic patterns in the building.Work is typically conducted on open bench tops usingstandard microbiological practices.Special containment equipment or facility design is not
required,Laboratory personnel must have specific training in theprocedures conducted in the laboratory and must besupervised by ascientist with training in microbiology or a related
science.
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Biosafety Level 1
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Biosafety Level 1
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Biosafety Level 2
Builds upon BSL-1BSL-2 is suitable for work involving agents that posemoderate hazards to personnel and the environment.Laboratory personnel have specific training in handling
pathogenic agentsPersonnel are supervised by scientists competent inhandling infectious agents and associated proceduresAccess to the laboratory is restricted when work is beingconducted
all procedures in which infectious aerosols or splashesmay be created are conducted in biological safetycabinets (BSCs) or other physical containmentequipment.
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MandatoryWarning Sign
Designate
Biosafety LevelSpecial EntryProcedures Immunizations
PPEContactInformation
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Biosafety Level 2
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Biosafety Level 3
Is applicable to clinical, diagnostic, teaching, research, orproduction facilities where work is performed with indigenous orexotic agents that may cause serious or potentially lethal diseasethrough inhalation route exposure.Laboratory personnel must receive specific training in handlingpathogenic and potentially lethal agents
Must be supervised by scientists competent in handling infectiousagents and associated procedures.Biosafety Level 2 plus all procedures involving the manipulation ofinfectious materials must be conducted within BSCs, or otherphysical containment devicesPersonnel wear additional appropriate personal protective
equipment including respiratory protection as determined by riskassessmentA BSL-3 laboratory has special engineering and design features. Directional air flow
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Biosafety Level 3
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Biosafety Level 3
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Biosafety Level 4Required for work with dangerous and exotic agents that pose ahigh 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 agentsrequiring BSL-4 containment must be handled at this level untilsufficient data are obtained either to confirm continued work at thislevel, or re-designate the level.Laboratory staff must have specific and thorough training in
handling extremely hazardous infectious agents.Laboratory staff must understand the primary and secondarycontainment functions of standard and special practices,containment equipment, and laboratory design characteristics.All laboratory staff and supervisors must be competent in handlingagents and procedures requiring BSL-4 containment.
Access to the laboratory is controlled by the laboratory supervisor inaccordance with institutional policiesTwo types of laboratory providing absolute separation of the workerfrom the infectious agents Suit Laboratory Cabinet Laboratory
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Biosafety Level 4
osa ety eve ummary a e
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osa ety eve ummary a e
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BSL-2
BSL-3
BSL-1
CDC/NIH GuidelinesBiosafety Levels
(www.cdc.gov)
Lower Risk
Higher
Risk
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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
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Risk Group 2 Agents
Moderate individual risk, low communityrisk
Pathogen causes human or animaldisease but is unlikely to be a serious
hazard to laboratory workers, thecommunity, livestock or the environment
May cause serious infection but effectivetreatments and preventive measures are
availableRisk of spread is limited
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Risk Group 3 Agents
High individual risk, low community risk
Pathogen usually causes serioushuman or animal disease but does notordinarily spread to others
Effective treatment and preventivemeasures are available
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Risk Group 4 Agents
High individual and community risk
A pathogen causes serious human oranimal disease; readily transmitted fromone individual to another
Effective treatment and preventivemeasures are usually not available
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Risk Groups and Biosafety Levels
RiskGroup
BiosafetyLevel
Laboratory Type LaboratoryPractices
SafetyEquipment
1
Basic Biosafety
Level 1
Basic teaching,research
GMT None; openbench work
2
Basic BiosafetyLevel 2
Primary healthservices;diagnostic
services,research
GMT plusprotectiveclothing,
biohazardssign
Open benchplus BSC foraerosols
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Risk Groups and Biosafety Levels
RiskGroup
Biosafety Level Laboratory Type LaboratoryPractices
SafetyEquipment
3
Containment-BiosafetyLevel 3
Specialdiagnosticservices,
research
Level 2 +special clothing,access control,
directed airflow
BSC and/orother primarydevices for all
activities
4
MaximumContainmentBiosafetyLevel 4
Dangerouspathogen units
Level 3 + airlockentry, showerexit, specialwaste disposal
Class III BSC,or positivepressure suiteswith class IIBSCs, doubleendedautoclave
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