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New York State Department of Health
Wadsworth CenterWadsworth Center
Biological Risk AssessmentBiological Risk Assessment
David HillDavid HillDirector, Safety and SecurityDirector, Safety and Security
Wadsworth CenterWadsworth CenterNew York State Department of HealthNew York State Department of Health
Risk Assessment WebinarRisk Assessment WebinarJune 15, 2011June 15, 2011
New York State Department of Health
Wadsworth CenterWadsworth Center
Biohazard Risk AssessmentBiohazard Risk Assessment
•• What is it?What is it?–– AgentAgent--based based qualitativequalitative risk risk estimateestimate..
•• Safe when risk associated with task is considered Safe when risk associated with task is considered to be acceptable.to be acceptable.
•• What needs to be reviewed?What needs to be reviewed?–– From accessioning to waste disposal.From accessioning to waste disposal.
•• Most important component is professional Most important component is professional judgment.judgment.
New York State Department of Health
Wadsworth CenterWadsworth Center
Why do it and document it?Why do it and document it?
Standards & guidelines driving biohazard risk Standards & guidelines driving biohazard risk assessments:assessments:
OSHA Bloodborne Pathogen Standard (29 CFR OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030)1910.1030) ““Exposure control plans shall be update at least annually and Exposure control plans shall be update at least annually and
whenever necessary to whenever necessary to reflect new or modified tasks and reflect new or modified tasks and procedures which affect occupational exposureprocedures which affect occupational exposure..””
““Document annual consideration and implementation of Document annual consideration and implementation of appropriate and effective safer medical devices designed to appropriate and effective safer medical devices designed to eliminate or minimize occupational exposureeliminate or minimize occupational exposure..”” (Needlestick (Needlestick Safety and Prevention Act, 2000)Safety and Prevention Act, 2000)
New York State Department of Health
Wadsworth CenterWadsworth Center
Why do it and document it?Why do it and document it?
Standards & guidelines driving biohazard risk Standards & guidelines driving biohazard risk assessments:assessments:
OSHA Bloodborne Pathogen Standard (29 CFR OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030)1910.1030)
The CDC/NIH Booklet The CDC/NIH Booklet ““Biosafety in Microbiological and Biosafety in Microbiological and Biomedical Laboratories (BMBL)Biomedical Laboratories (BMBL)””, 5th Edition (2007), 5th Edition (2007)
New York State Department of Health
Wadsworth CenterWadsworth Center
Evolution of CDC/NIH BMBL Evolution of CDC/NIH BMBL
New York State Department of Health
Wadsworth CenterWadsworth Center
Why do it and document it?Why do it and document it?
Standards & guidelines driving biohazard risk Standards & guidelines driving biohazard risk assessments:assessments:
OSHA Bloodborne Pathogen Standard (29 CFR OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030)1910.1030)
The CDC/NIH Booklet The CDC/NIH Booklet ““Biosafety in Microbiological and Biosafety in Microbiological and Biomedical Laboratories (BMBL)Biomedical Laboratories (BMBL)””, 5th Edition (2007), 5th Edition (2007)
NYS DOH CLEP NYS DOH CLEP –– Safety Standards (Effective Safety Standards (Effective November 1, 2010)November 1, 2010) Revised to be consistent with BMBLRevised to be consistent with BMBL
CDC/APHIS CDC/APHIS -- Select Agent Regulations: Possession, Select Agent Regulations: Possession, use, and transfer of select agents.use, and transfer of select agents.
New York State Department of Health
Wadsworth CenterWadsworth Center
Risk AssessmentRisk Assessment
New York State Department of Health
Wadsworth CenterWadsworth Center
Biosafety Risk Assessment and Biosafety Risk Assessment and Management ProcessManagement Process
Five step processFive step process::Risk AssessmentRisk Assessment
1)1) Perform comprehensive hazard evaluation and Perform comprehensive hazard evaluation and determine initial biosafety level (BSL).determine initial biosafety level (BSL).
2)2) Identify laboratory procedure hazardsIdentify laboratory procedure hazards1)1) Determining riskDetermining risk2)2) Determining acceptability of riskDetermining acceptability of risk
Risk ManagementRisk Management3)3) Determine final containment (BSL) with any additional Determine final containment (BSL) with any additional
safety enhancementssafety enhancements4)4) Evaluate staff proficiency and safety equipment integrityEvaluate staff proficiency and safety equipment integrity5)5) Review with knowledgeable individualsReview with knowledgeable individuals
New York State Department of Health
Wadsworth CenterWadsworth Center
Biosafety Risk AssessmentBiosafety Risk Assessment
(Agent Hazards)(Agent Hazards) (Lab Procedure Hazards)(Lab Procedure Hazards)
New York State Department of Health
Wadsworth CenterWadsworth Center
Agent HazardsAgent Hazards
•• What are the principle hazardous What are the principle hazardous characteristics of an agent?characteristics of an agent?
–– Its capability to infect and cause diseaseIts capability to infect and cause disease–– The severity of the diseaseThe severity of the disease–– Availability of preventative measures and Availability of preventative measures and
treatments for the diseasetreatments for the disease–– Route of transmissionRoute of transmission
•• Transmission via aerosol is most serious hazard.Transmission via aerosol is most serious hazard.–– Infective dose and agent stability key factors.Infective dose and agent stability key factors.
–– History of LaboratoryHistory of Laboratory--acquired infection (LAI)acquired infection (LAI)
New York State Department of Health
Wadsworth CenterWadsworth Center
Determine the proper risk groupDetermine the proper risk group
RISK GROUP 1:
RISK GROUP 2:
RISK GROUP 3:
RISK GROUP 4:
Agents are not associated with disease in healthy human adults
Agents associated with human diseases that are rarely serious. Effective preventive or treatment options are often available.
Agents are associated with serious or potentially lethal diseases for which effective preventive or treatment options may be available.
Agents are likely to cause serious or lethal disease. Effective preventive or treatment options are not usually available.
New York State Department of Health
Wadsworth CenterWadsworth Center
Section VIIISection VIIIAgent Summary StatementsAgent Summary Statements
•• Good Source of Info:Good Source of Info:–– AgentAgent
–– Occupational InfectionsOccupational Infections
–– Natural Modes of InfectionNatural Modes of Infection
–– Laboratory SafetyLaboratory Safety
–– Containment RecommendationsContainment Recommendations
–– Special IssuesSpecial Issues•• VaccinesVaccines
•• Select AgentSelect Agent
•• Transfer of AgentTransfer of Agent
•• Post Exposure Treatment Post Exposure Treatment
New York State Department of Health
Wadsworth CenterWadsworth Center
Material Safety Data SheetsMaterial Safety Data Sheets
•• MSDSs are available for certain MSDSs are available for certain infectious agents.infectious agents.
•• Health Canada Office of Laboratory SecurityHealth Canada Office of Laboratory Security
•• MSDS content:MSDS content:–– Section 1: Infectious AgentSection 1: Infectious Agent
–– Section 2: Health HazardSection 2: Health Hazard
–– Section 3: DisseminationSection 3: Dissemination
–– Section 4: ViabilitySection 4: Viability
–– Section 5: Medical Section 5: Medical
–– Section 6: Laboratory HazardsSection 6: Laboratory Hazards
–– Section 7: Recommended PrecautionsSection 7: Recommended Precautions
–– Section 8: Handling InformationSection 8: Handling Information
–– Section 9: Miscellaneous InformationSection 9: Miscellaneous Information
New York State Department of Health
Wadsworth CenterWadsworth Center
Agent HazardsAgent Hazards
•• What about clinical specimens with What about clinical specimens with unknown risks?unknown risks?–– Past experiencePast experience
•• Have you seen high risk agents in your lab?Have you seen high risk agents in your lab?
–– Medical data on patient if available.Medical data on patient if available.–– Geographic origin of specimenGeographic origin of specimen–– Ad hoc guidelines during outbreaks (e.g., West Ad hoc guidelines during outbreaks (e.g., West
Nile Virus, SARSNile Virus, SARS--CoV, etc).CoV, etc).
New York State Department of Health
Wadsworth CenterWadsworth Center
Lab Procedure HazardsLab Procedure Hazards
Assess specific tasks within each method or procedure.
Consider all sources and routes of exposure:
Manipulations that produce droplets and aerosols
Pipetting, blenders, centrifuges (without primary containment), sonicators, and vortex mixers
Manipulations involving sharps
Manipulations with high potential for spills and splashes
New/emerging technologies
New York State Department of Health
Wadsworth CenterWadsworth Center
Lab Procedure HazardsLab Procedure Hazards
Assess automated systems and other emerging technology for exposure risks.
New York State Department of Health
Wadsworth CenterWadsworth Center
Lab Procedure HazardsLab Procedure Hazards
•• Important to define what constitutes an Important to define what constitutes an ““exposure incidentexposure incident”” or or ““occupational occupational exposureexposure”” in advance of incidents.in advance of incidents.–– Exposure incidentExposure incident (OSHA BBP): (OSHA BBP): ““means a specific means a specific
eye, mouth, or other mucous membrane, noneye, mouth, or other mucous membrane, non--intact skin, or parenteral contact with blood or intact skin, or parenteral contact with blood or OPIMOPIM…”…”
–– Occupational exposureOccupational exposure (CDC/APHIS Select Agent (CDC/APHIS Select Agent Regulations): Regulations): ““Any event that results in any Any event that results in any personperson…….not being appropriately protected in the .not being appropriately protected in the presence of an agent or toxinpresence of an agent or toxin…”…”
New York State Department of Health
Wadsworth CenterWadsworth Center
Risk ManagementRisk Management
New York State Department of Health
Wadsworth CenterWadsworth Center
Biosafety Risk Assessment and Biosafety Risk Assessment and Management ProcessManagement Process
Five step processFive step process::Risk AssessmentRisk Assessment
1)1) Perform comprehensive hazard evaluation and Perform comprehensive hazard evaluation and determine initial biosafety level (BSL).determine initial biosafety level (BSL).
2)2) Identify laboratory procedure hazardsIdentify laboratory procedure hazards1)1) Determining riskDetermining risk2)2) Determining acceptability of riskDetermining acceptability of risk
Risk ManagementRisk Management3)3) Determine final containment (BSL) with any additional Determine final containment (BSL) with any additional
safety enhancementssafety enhancements4)4) Evaluate staff proficiency and safety equipment integrityEvaluate staff proficiency and safety equipment integrity5)5) Review with knowledgeable individualsReview with knowledgeable individuals
New York State Department of Health
Wadsworth CenterWadsworth Center
•• OSHA Bloodborne Pathogen StandardOSHA Bloodborne Pathogen Standard–– Shall establish a written Exposure Control PlanShall establish a written Exposure Control Plan
•• CDC/NIH BMBLCDC/NIH BMBL–– A laboratoryA laboratory--specific biosafety manual must be prepared specific biosafety manual must be prepared
and adopted as policyand adopted as policy–– Four recommended laboratory practicesFour recommended laboratory practices
•• Biosafety levels 1 Biosafety levels 1 -- 44
•• NYSDOH CLEP StandardNYSDOH CLEP Standard–– Shall describe use of biosafety equipment, practices, Shall describe use of biosafety equipment, practices,
and procedures in laboratoryand procedures in laboratory’’s safety manual.s safety manual.–– Minimally meet biosafety level 2Minimally meet biosafety level 2
•• Describe additional procedures for suspected high risk Describe additional procedures for suspected high risk pathogens.pathogens.
Managing Risks Managing Risks
New York State Department of Health
Wadsworth CenterWadsworth Center
Thank You!Thank You!
David HillDavid HillDirector, Safety and SecurityDirector, Safety and SecurityWadsworth CenterWadsworth Center(518) 486(518) 486--38743874Email:Email: [email protected]@health.state.ny.us