Risk Assessment Flow Chart - Sandia National Laboratories

Risk Assessment FlowChartSAND No. 2009-1579PSandia is a multiprogram laboratory operated by Sandia Corporation, a Lockheed Martin Company,for the United States Department of Energy’s National Nuclear Security Administrationunder contract DE-AC04-94AL85000.

Risk Assessment Modelfor handling BiologicalMaterial/AgentsDoes the biological agent causedisease in humans, animals, orplants?YESNONo need to conduct aformal risk assessmentYESDoes the biological agentimpact the plant population?YESDefine risk to plant community indirect region of laboratoryYESYESDoes the biological agentimpact the animal population?YESDefine risk to animal community indirect region of laboratoryDoes the biological agentimpact the human population?YESDefine risk to humans working in thelaboratory, around the laboratory andthose who live and/or work in directregion of laboratory

For each defined risk:Plant, Human, AnimalDefine factorsabout the biological agent which scale theconsequence of disease to each populationBiological Agent FactorsAgent Characteristics (allergenic,carcinogenic, toxin production,abortogenic)Morbidity (Duration of illness,severity of illness, duration ofinfection, sequelae)Mortality (untreated mortality)Treatment options (diagnostic tests,anti-microbials, vaccines)Define factorsabout the biological agent which scale thelikelihood of infection to each populationBiological Agent FactorsRoute of InfectionInfectious DoseStabilityExistence of prophylaxis

For each research project:Accidental exposure risk toindividuals performing directmanipulation of the agentDefine factorsabout the research which scale thelikelihood for exposureLaboratory FactorsInhalation potential (aerosolgenerating procedures, animal,experiments)Percutaneous or direct contactpotential (animals, needles, othersharps, splashes and spills)Ingestion potential (splashes)Quantity and Quality of infectiousmaterialDefine factorsabout the research which reduce thelikelihood for exposureBiosafety MeasuresManagement oversightPrimary ContainmentPPEProcedural/administrative

For each research project:Risks to human, animal, and orplant communities of accidentalexposureDefine factorsabout the research which scale thelikelihood for exposureLaboratory FactorsInhalation (contaminated air enteringclean space)Percutaneous (contaminated animalsor sharps entering clean space)Contact (contaminated solids/liquids,animals or people entering cleanspace)Ingestion (contaminated solid/liquidentering clean space)Quantity and Quality of infectiousmaterialDefine factorsabout the research which reduce thelikelihood for exposureBiosafety MeasuresManagement oversightSecondary ContainmentProcedural/administrative

Risk of theft of biological materialfrom laboratory for malicious useDefine factorsabout the potential adversaries to thelaboratoryAdversariesInsiders with direct accessInsiders without direct accessVisitorsOutsiders with criminal intentOutsiders with terrorist intentDefine factorsabout the laboratory which can reduce thepotential of the adversaries to acquire thebiological agentBiosecurity MeasuresManagement oversightPhysical securityPersonnel securityTransport securityMaterial controlInformation security

BIOSAFETY RISKFor each defined risk:Plant, Human, AnimalScorelikelihood of infection tothe individual or communityScorelikelihood for exposureOverall score of likelihood ofexposure and likelihood of infectionvia that exposureScore the measures toreduce the likelihood for exposure(subtract this score from the likelihood for exposure score)Scoreconsequence of diseasethe individual or communityOverall score consequence ofdisease

BIOSECURITY RISKFor each defined risk:Plant, Human, AnimalScorelikelihood of infectionof the communityScorethe potential adversaries means, motive tosteal from the laboratoryOverall score of likelihood of targetingand theft of a biological agent fromthe laboratoryScore the factorsabout the laboratory which can reduce thepotential of the adversaries to acquire thebiological agentScoreconsequence of diseaseto the communityOverall score consequence ofdisease

RISKFor each defined risk (biosafetyand biosecurity):Plant, Human, AnimalOverall score oflikelihoodLow Moderate High Extremely HighE.g.ow Moderate High Extremely HighOverall score consequence ofdisease