Biohazard Considerations
Institutional Biosafety Committee (IBC) Interim Lab Biosafety Guidance for Research with SARS-CoV-2 (COVID-19)
To support the increasing SARS-CoV-2 (COVID-19) research by Einstein investigators, in response to the rapidly evolving coronavirus pandemic, the Institutional Biosafety Committee (IBC) has developed the following guidelines and standard procedures for research with SARS-COV-2 virus or COVID-19 patient-derived materials.
Regulatory Approvals
Before any work can begin, an investigator must obtain all necessary approvals including Internal Review Board (IRB) for patient derived materials and health data, Institutional Biosafety Committee (IBC) for all worker handling biological materials, including virus, patient-derived samples, and recombinant nucleic acids, and Institutional Animal Care and Use Committee (IACUC) for studies performed in animals.
Human tissues, fluids, and other products (including blood, urine, saliva, fecal materials, etc.) that are taken to and analyzed within the Montefiore clinic or pathology laboratory solely for diagnostic purposes only are not subject to Institutional Biosafety Committee (IBC) review. However, any human tissues, fluids, and other products that are to be used for research purposes, and taken to research laboratories or Shared Facilities at Einstein, must receive appropriate IBC approval.
Before committing to receive assumed infectious materials, the investigator must conduct a thorough risk assessment, before defining the risks and controls, and submit a written proposal and SOP to the IBC for approval.
NOTE: All COVID-19 patient derived materials are to be assumed to be infectious until proven otherwise or rendered non-infectious by an IBC approved inactivation technique. SARS-COV-1 is regulated as a Select Agent by the CDC. It is likely that SARS-COV-2 will also be regulated in the research environment as a Select Agent. Therefore the IBC has added guidelines for record keeping and secure storage of archived materials.
Handling and processing samples from convalescent COVID-19 patients
The handling and processing of samples from convalescent patients will require biosafety level (BSL)-2 containment with BSL-3 practices. See page 38, Biosafety in Microbiological and Biomedical Laboratories (BMBL), CDC. Most importantly, this requires strict hand washing and wearing proper personal protective protective equipment (PPE) such as:
- A solid-front, such as tie-back or wrap-around gowns, scrub suits, or coveralls.
- Protective clothing is not worn outside of the laboratory. Reusable clothing is decontaminated before being laundered. Clothing is changed when contaminated.
- Eye and face protection (goggles, mask, face shield or other splash guard) is used for anticipated splashes or sprays of infectious or other hazardous materials.
- Eye and face protection must be disposed of with other contaminated laboratory waste or decontaminated before reuse.
- Mask may be a surgical mask.
- Gloves must be worn to protect hands from exposure to hazardous materials.
- Change gloves when contaminated, glove integrity is compromised, or when otherwise necessary. Wear two pairs of gloves when appropriate.
- Remove gloves and wash hands when work with hazardous materials has been completed and before leaving the laboratory.
- Do not wash or reuse disposable gloves. Dispose of used gloves with other contaminated laboratory waste. Hand washing protocols must be rigorously followed.
Samples should be rendered non-infectious by an IBC approved technique as soon as possible after collection. Samples that cannot be immediately inactivated (blood, plasma, nasopharyngeal swabs) must be tested with RT-PCR to demonstrate that the samples are negative before conducting experiments outside BSL-2 containment. Samples that test POSITIVE by RT-PCR are to be considered infectious. Samples that test POSITIVE must be inactivated by an approved technique or discarded, unless scientific rationale is provided for the need to retain the positive sample. Such samples must be properly identified and logged into secure storage and handled as samples from active COVID-19 patients (below).
Please note, if appropriate is not available due to shortages, then activities must be suspended.
Handling and processing tissue samples from active COVID-19 patients
With the exception of blood and plasma, samples should be rendered non-infectious by an IBC approved technique as soon as possible after collection. Samples such as nasopharyngeal swabs that cannot be immediately inactivated are to be considered infectious and must be processed under BSL-3 containment until rendered non-infectious.
Virus isolation in cell culture and initial characterization of viral agents recovered from cultures of SARS‐CoV‐2 specimens must be conducted in BSL-3 labs. Any research culture or propagation of the virus or propagation of the viral genome (plasmid, BAC clones) must be performed in BSL-3 containment labs. Transfection of cell cultures with recombinant viral gene fragments sufficient to produce infectious virus must be performed in BSL-3 containment. Infection of animal models with patient derived materials or cell cultures or media containing SARS-COV-2 must be done in animal BSL-3 containment.
The IBC makes final determination of containment conditions for research projects and may add or reduce guidance based on available information. Individuals who are immunosuppressed or have medical conditions or are otherwise at higher risk that might contribute to negative outcomes if infected by SARS‐CoV‐2 are strongly discouraged from conducting research on samples from active COVID-19 patients.
Handling and processing blood samples from active COVID-19 patients
Research involving molecular or other types of analyses of human blood, will be permitted using BSL-2 containment with BSL-3 practices as described above. Most importantly, this requires wearing protective personal protective equipment as described above and strict hand washing.
Approved Inactivation Techniques to render biological materials non-infectious.
Direct fixation of tissue, swab samples, or whole blood using fixative such as paraformaldehyde or direct lysis in a detergent-containing extraction buffer.
Heat inactivation of plasma/serum maybe conducted at a minimum of 56 ℃ for 60 minutes. Addition of a mild detergent solution may allow for shortened heat inactivation time (e.g. 56 ℃ for 30 minutes). All inactivation procedures must be validated and approved by the IBC.
For further information, please contact:
Delia Vieira-Cruz
Laboratory Safety Officer 718-430-3560
delia.vieira-cruz@einsteinmed.org