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1、OfficeofLaboratorySecurityBureaudelasécuritédeslaboratoiresCentreforEmergencyPreparednessandCentredemesuresetd’interventionsd’urgenceResponsePublicHealthAgencyofCanadaAgencedesantépubliqueduCanadaOttawa,ONK1A0K9Ottawa,ONK1A0K9Telephone:(613)957-1779Téléphone:(613)
2、957-1779Fax:(613)941-0596Télécopieur:(613)941-0596FormE-DocumentSubmissionTRequirementsfortheTCertificationPerformanceandVerificationTestingofContainmentLevel(CL)4LaboratoriesinAccordancewiththeLaboratoryBiosafetyGuidelines,T2004,TPublicHealthAgencyofCanada(andwhe
3、reapplicable,ContainmentStandardsforVeterinaryFacilities,1996,CanadianFoodInspectionAgency)ItemRequiredInformationNotes/SuggestionsA.ContactsVProvidethename,title,faxandphonenumbersofakeycontactforinquiriesregardingthesubmissioncontents,alsosupplythoseoftheinstitu
4、tedirector,principalinvestigator(labsupervisor),facilitiesmanager,andbiosafetyofficer.B.ProgramIntentVGiveabriefoverviewoftheagentstobeusedandprocedurestobe♦Informationtoinclude:maximumfollowedinyourfacility,aswellasthegeneralgoal/purposeofthework.volumestobeworke
5、dwith,identificationVAtanytimethereisachangeinagentsusedorasignificantchangeinofanyproceduresthatmayproduceprocedures,youarerequiredtoinformthisofficeimmediately.aerosols,etc.C.DrawingsandSpecificationsVAll“asbuilt”drawingsforthefacilityincludingarchitectural,mech
6、anical♦Drawingsforassociatestructures/services(HVAC,plumbing,piping,drainage),electrical,andcontrolschematics.Ifarealsorequired,forexample:biowaste“asbuilt”drawingsarenotavailable,tenderorconstructiondrawingswithsystem,incinerator,etc.changeordersareacceptable.VSp
7、ecificationsaslistedaboveincludingsequenceofoperations.♦Indicatethecontainmentbarrieronalldrawings.Version1.0–August20051of8ItemRequiredInformationNotes/SuggestionsD.Verification&PerformanceTestingVForeachrequiredtestorverification,describethetestprocedure,accepta
8、ncecriteria,observations,Tresults,pass/failTTdecision,namesT,dates,signatures,witnessesandcorrectivemeasuresrequired.1.RoomIntegrityVVisuallyandwithaTsm
