1-0200 biosafety program development presented by: lisa wisser, cih aihce - june 6, 2001
TRANSCRIPT
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Biosafety Program Biosafety Program DevelopmentDevelopment
Presented by:Presented by:
Lisa Wisser, CIHLisa Wisser, CIH
AIHCE - June 6, 2001AIHCE - June 6, 2001
MROE Environmental
Risk Managementand Occupational
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OutlineOutline
Who Needs a Biosafety Program?Who Needs a Biosafety Program? Program ElementsProgram Elements Program ManagementProgram Management
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You Need a Program When...You Need a Program When...
You use Risk Group 3 or 4 agentsYou use Risk Group 3 or 4 agents Otherwise:Otherwise:
– Are you using Risk Group 2 agents or Are you using Risk Group 2 agents or materials?materials?
– ……in high concentrations or large in high concentrations or large quantities? quantities?
– ……in aerosol generating procedures?in aerosol generating procedures?
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You Need a Program When...You Need a Program When...
Regulators insistRegulators insist– OSHA - Bloodborne PathogensOSHA - Bloodborne Pathogens– CDC - Select Agents and ToxinsCDC - Select Agents and Toxins– NIH - Recombinant DNANIH - Recombinant DNA– USDA APHIS - Plant PathogensUSDA APHIS - Plant Pathogens
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You Need a Program When...You Need a Program When...
No matter what agents or No matter what agents or materials are used:materials are used:– One of your employees develops a One of your employees develops a
laboratory-acquired infectionlaboratory-acquired infection– Your researchers disregard standard Your researchers disregard standard
microbiological practices or lack microbiological practices or lack training in microbiologytraining in microbiology
– Your customer requires a program Your customer requires a program
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Biosafety Program GoalsBiosafety Program Goals
Assist laboratory research and Assist laboratory research and support personnel in working safely support personnel in working safely with biological agents and materialswith biological agents and materials
Meet regulatory requirements and Meet regulatory requirements and guidelinesguidelines
Provide a competitive advantage to Provide a competitive advantage to the organizationthe organization
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Go!
Tools
Committee
Needs assessment
Management support
Program DevelopmentProgram Development
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Go!
ToolsCommittee
Needs assessment Management support
Program DevelopmentProgram Development
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Program ElementsProgram Elements
Management supportManagement support– Laboratory managementLaboratory management
Responsible for safety in the laboratoriesResponsible for safety in the laboratories
– Facility managementFacility management Facility maintenance and improvementFacility maintenance and improvement
– EHS managementEHS management Technical supportTechnical support Program coordinationProgram coordination
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Program ElementsProgram Elements
Needs AssessmentNeeds Assessment– Listen to the research staffListen to the research staff– Facility walkthroughFacility walkthrough
Inspection formInspection form Keep records andKeep records and
follow upfollow up Report to CommitteeReport to Committee
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Program ElementsProgram Elements
Needs AssessmentNeeds Assessment– SurveySurvey
Mail, e-mail, in person, etc.Mail, e-mail, in person, etc. Who works with what whereWho works with what where
– Records reviewRecords review Training - identify needs such as emergency Training - identify needs such as emergency
and spill response, waste handling, hazard and spill response, waste handling, hazard identification, and exposure controlidentification, and exposure control
Medical SurveillanceMedical Surveillance
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Program ElementsProgram Elements
Institutional Biosafety Committee Institutional Biosafety Committee (IBC)(IBC)– MembersMembers
Principal Investigators / MicrobiologistsPrincipal Investigators / Microbiologists Occupational PhysicianOccupational Physician Biosafety Specialist Biosafety Specialist EHS Team / Emergency ResponseEHS Team / Emergency Response Other SpecialistsOther Specialists
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Program ElementsProgram Elements
Institutional Biosafety Committee Institutional Biosafety Committee (IBC)(IBC)– ProceduresProcedures– Risk AssessmentRisk Assessment
PathogensPathogens rDNArDNA Select agentsSelect agents Human blood and tissuesHuman blood and tissues Other hazardsOther hazards
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Program ElementsProgram Elements
Institutional Biosafety Committee Institutional Biosafety Committee (IBC)(IBC)– Coordinate with other committeesCoordinate with other committees
Animal Care and Use Animal Care and Use Human Subjects ReviewHuman Subjects Review Radiation SafetyRadiation Safety Laboratory SafetyLaboratory Safety
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Program ElementsProgram Elements
ToolsTools– Biological Use Authorization FormBiological Use Authorization Form
Researcher informationResearcher information Agents/materials usedAgents/materials used rDNA informationrDNA information Work descriptionWork description Others…Others…
– Renewal period - e.g., 2/3 yrsRenewal period - e.g., 2/3 yrs
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Program ElementsProgram Elements
ToolsTools– DatabaseDatabase
Track BUAsTrack BUAs Agents/materialsAgents/materials ResearchersResearchers LaboratoriesLaboratories OthersOthers
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Program ElementsProgram Elements
ToolsTools– Develop standard procedures, such Develop standard procedures, such
as:as: Standard microbiological practicesStandard microbiological practices Sample receipt Sample receipt and handlingand handling Decontamination Decontamination Waste handlingWaste handling Packaging andPackaging and shipmentshipment
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Program ElementsProgram Elements
ToolsTools– More standard procedures...More standard procedures...
Biological safety cabinet use and Biological safety cabinet use and maintenancemaintenance
Spill and emergency responseSpill and emergency response Ventilation requirementsVentilation requirements SharpsSharps PPEPPE
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Program ElementsProgram Elements
Go!Go!– Beta testBeta test– Roll out to all identified on databaseRoll out to all identified on database
Communicate expectationsCommunicate expectations Train on proceduresTrain on procedures
– Offer extensive helpOffer extensive help Resources - person to answer questions, Resources - person to answer questions,
web resources, web site, forms, etc. web resources, web site, forms, etc.
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Program ElementsProgram Elements
Go!Go!– More on trainingMore on training
introductory laboratory biosafetyintroductory laboratory biosafety annual BBP and biosafety refresherannual BBP and biosafety refresher IBC proceduresIBC procedures specialized situations - new lab workspecialized situations - new lab work emergency response emergency response
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Program ManagementProgram Management
ResponsibilitiesResponsibilities– ResearchersResearchers– IBCIBC– Biosafety OfficerBiosafety Officer
ProcessesProcesses– Medical Medical
surveillancesurveillance– TrainingTraining– Safety proceduresSafety procedures– Spill responseSpill response– Emergency Emergency
responseresponse– Periodic program Periodic program
reviewreview
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Program ManagementProgram Management
ElementsElements– Audits and inspectionsAudits and inspections– Quarterly reports to IBCQuarterly reports to IBC– Ongoing communication with other Ongoing communication with other
committeescommittees– Regulatory compliance - BBP, select Regulatory compliance - BBP, select
agents, medical waste, rDNA, BMBLagents, medical waste, rDNA, BMBL
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SummarySummary
Evaluate what you need in a Evaluate what you need in a “program”“program”
Roll out the program in a logical Roll out the program in a logical sequencesequence
Ensure consistent program Ensure consistent program managementmanagement
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Useful ResourcesUseful Resources
http://www.cdc.gov/od/ohs/default.htm (CDC OHS)http://www.cdc.gov/od/ohs/default.htm (CDC OHS) http://www.cdc.gov/od/ohs/biosfty/bmbl4/http://www.cdc.gov/od/ohs/biosfty/bmbl4/
bmbl4toc.htm (BMBL)bmbl4toc.htm (BMBL) http://www.cdc.gov/od/ohs/lrsat.htm (LR/SAT)http://www.cdc.gov/od/ohs/lrsat.htm (LR/SAT) http://www4.od.nih.gov/oba/rdna.htm http://www4.od.nih.gov/oba/rdna.htm http://www.absa.org/ http://www.absa.org/ http://www.hhmi.org/http://www.hhmi.org/ Biological Safety, Principles and PracticesBiological Safety, Principles and Practices. 3rd . 3rd
edition. Ed. by D. O.Fleming and D. L. Hunt. ASM edition. Ed. by D. O.Fleming and D. L. Hunt. ASM Press. Press.