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& ACTION GRID: RESEARCH ACTIVITIES INVOLVING COVID-19 SPECIMENS & SARS-CoV-2 MATERIALS

Activities/Materials Examples IBC Action Needed Key Biosafety Elements • in cell culture Operational BSL-3 lab with personnel who have Restricted activity. Contact BSL-3 completed BSL-3 lab training through a recognized • Initial characterization of viral Biosafety Officer (BSO) directly for Lab research activities involving the agents recovered in cultures of program and have been deemed proficient by handling of the SARS-CoV-2 virus or information. SARS-CoV-2 experienced BSL-3 laboratorians in conjunction with aerosol-generating procedures with the BSO. viable clinical specimens or tissues • Plasmablast/B cell processing of known to contain the virus large volume specimens known to contain the virus • Centrifugation, vortexing or • Submit completed COVID-19 • Facilities & biocontainment practices will be BSL-2 with Enhanced pipetting of viable clinical Specimen Intake form, IBC commensurate with those outlined in IBC Biocontainment Practices specimens (i.e. blood amendment, all applicable Policy: 2 with Enhanced Aerosol-generating lab activities with components, nasal swabs, SOPs, permits and IRB Practices (BSL-2+) for Basic Research viable/unfixed clinical specimens from sputum) collected from known or approvals to VEHS Biosafety. Applications. known or strongly suspected COVID+ strongly suspected infected • Complete a risk assessment individuals patients for research purposes. with VEHS Biosafety. • Using automated instruments If activities will be carried out in a Vanderbilt research labs and associated activities BSL-2 and analyzers Vanderbilt lab research space, then that need to carry out activities under BSL-2 Lab research activities with materials • Staining and microscopic submit an IBC amendment conditions need the following: that do not involve direct handling of analysis of fixed smears including the following details: • An approved registration with the entity’s viable/unfixed clinical specimens from • What materials will be received Institutional Biosafety Committee (IBC) known or strongly suspected COVID+ • Examination of bacterial cultures and from whom (if RDNA or • Personnel who have completed biosafety individuals • Pathologic examination and -related synthetic training and the PI/lab supervisor has processing of formalin-fixed or RNA, provide details of genetic documented their proficiency at carrying out otherwise inactivated tissues elements and how they will be technical procedures under BSL-2 conditions. • Molecular analysis of extracted used) • Lab space that is: nucleic acid preparations • What activities will take place, o restricted access and physically • Final packaging of specimens for what purpose, and for how separated from carpeted areas and for transport long food/drink areas; Risk assessment grid based on: • Using inactivated specimens, • Where these activities will take o free of fabric furniture, plants and

such as specimens in nucleic place animals not associated with research; • CDC’s Frequently Asked acid extraction buffer o Questions about Laboratory • Who will be doing the work equipped with and handwashing sink in • Performing electron microscopic the space and an eyewash in close Biosafety and SARS-CoV-2 • Identify any aerosol-generating studies with glutaraldehyde- proximity; procedures (centrifugation, • CDC/NIH Biosafety in fixed grids sonication, etc.) and what o equipped with a method for biowaste Microbiological and Biomedical measures will be taken to decontamination; Laboratories, 5th ed. o equipped with a BSC, centrifuge with contain aerosols (i.e., carrying sealed rotors or any other containment Prepared by VEHS Biosafety & the out procedures in a biosafety Vanderbilt Institutional ). equipment as determined through Committees 3/2020 biorisk assessment.