Biorisk Management System |
Oversight by Biorisk Management Committee, with expertise in biosafety, biosecurity, physical security, facility engineering, and occupational health |
Risk Assessment |
Written risk assessments must be developed for each laboratory protocol/method in the containment laboratory; risk mitigation plans |
Poliovirus Inventory and Information |
Accurate inventory of poliovirus infectious materials; periodic review of inventory |
General Safety |
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Personnel and Competency |
Recruitment, training, competence, continuity and succession planning |
Good Microbiological Technique |
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Clothing and Personal Protective Equipment (PPE) |
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Human Factors |
Institutional policies to address risk associated with human behavior |
Health Care |
Occupational health program, proof of poliovirus immunization and proof of immunity (requires neutralization assay) |
Emergency Response and Contingency Planning |
Anticipate all credible emergency scenarios; logistics for specimen collection and testing in the event of a release or laboratory exposure; coordination with local, state/provincial, and national emergency and public health authorities |
Accident/Incident Investigation |
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Facility Physical Requirements |
Facility design and verification; infrastructure and operations: emergency shower, effluent decontamination |
Equipment and Maintenance |
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Decontamination, Disinfection, and Sterilization |
Management of biological waste, inactivation of poliovirus (e.g. RNA extraction for downstream processes) by validated methods |
Transport Procedures |
Material transport within the facility and to/from other facilities |
Security |
Physical security, information security, personnel control, personal security, contractors/visitors/suppliers |