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Interim Guidelines for Biosafety and COVID-19

What to know

This guidance is intended for clinical laboratory and support staff who handle or process specimens associated with COVID-19.

Summary of recent changes

Updates as of December 13, 2021:

  • Updated waste management guidance

View previous updates

Key points

Keep in mind‎

All clinical specimens may contain potentially infectious materials. Precautions must be taken when handling specimens suspected or confirmed to be positive for SARS-CoV-2, the virus that causes COVID-19. Timely communication between clinical and laboratory staff is essential to minimize the potential risk of handling specimens from patients with possible SARS-CoV-2 infection. These specimens should be labeled accordingly, and the receiving laboratory should be alerted to ensure proper specimen handling. Specific and general biosafety guidelines for handling suspected and confirmed SARS-CoV-2 specimens are provided below.

SARS-CoV-2 specific guidance

To determine appropriate biosafety mitigation measures, laboratories should perform an activity-specific comprehensive risk assessment that evaluates laboratory facilities, personnel and training, practices and techniques, safety equipment, engineering controls, and other risk mitigation measures. Biosafety professionals, laboratory management, and scientific and safety experts should be involved in the comprehensive risk assessment process.

At a minimum, BSL-2 facilities, practices, and procedures are recommended for diagnostic research, anatomic pathology, environmental, and virus propagation activities utilizing SARS-CoV-2. At a minimum, ABSL-2 is recommended for work with these viruses in animal models.

If work involves genetic modifications or large volumes of organisms (≥10 liters), please refer to the NIH Guidelines section II-A-3 for guidance on additional considerations to determine the appropriate Biosafety mitigation measures (https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2/).

For more information on BSL-2 and Clinical Laboratory Biosafety see section IV and Appendix N respectively, Biosafety in Microbiological and Biomedical Laboratories—6th Edition (cdc.gov).

General guidance

All laboratories should perform a site-specific and activity-specific comprehensive risk assessment to identify and mitigate risks. Comprehensive risk assessments and mitigation measures are dependent on:

  • The procedures performed
  • Identification of the hazards involved in the process and procedures
  • The competency level of the personnel who perform the procedures
  • The laboratory equipment and facility

Follow Standard Precautions | Section IV when handling clinical specimens, all of which may contain infectious materials. Standard Precautions include hand hygiene and the use of specific personal protective equipment (PPE) determined by the potential for exposure. PPE, such as laboratory coats or gowns, gloves, eye protection, or a disposable mask and face shield, can help protect the skin and mucous membranes of the eyes, nose, and mouth.

For more information:

For online training courses:

Specimen packing and shipping

Suspected or confirmed SARS-CoV-2 positive specimens, cultures, or isolates must be packed and shipped as UN 3373 Biological Substance, Category B, in accordance with the current edition of the International Air Transport Association Dangerous Goods Regulations and U.S. Department of Transportation's Transporting Infectious Substances Safely publication. Personnel must be trained to pack and ship according to the regulations and in a manner that corresponds to their function-specific responsibilities. See appendix C of the Biosafety in Microbiological and Biomedical Laboratories.

Procedures with a high likelihood of generating droplets or aerosols

Many routine laboratory procedures can generate aerosols and droplets that are often undetectable. For example, the following laboratory procedures have been associated with the generation of infectious aerosols and droplets: pipetting, centrifuging, grinding, blending, shaking, mixing, sonicating, vortexing, opening containers of infectious materials, inoculating animals intranasally, and harvesting infected tissues from animals or eggs.

Procedures with a high likelihood of generating aerosols or droplets should be conducted using either a certified Class II Biological Safety Cabinet (BSC) or other physical containment equipment. If it is not possible to perform a procedure within a BSC or other physical containment device, a combination of appropriate personal protective equipment (PPE) and administrative controls are used, based on a risk assessment.

Decontamination

Decontaminate work surfaces and equipment with appropriate disinfectants. Use EPA-registered disinfectants with a label that claims they are effective against SARS-CoV-2. Follow manufacturer's recommendations for use, such as dilution, contact time, and safe handling. For additional information, refer to EPA Resource Conservation and Recovery Act (RCRA) Regulations. See EPA regulations, State Universal Waste Programs in the United States, and Biosafety in Microbiological and Biomedical Laboratories-appendix B—6th Edition for more information.

Laboratory waste management

All waste disposal must comply with local, regional, state, national, and international regulations. Waste disposal regulations vary at the state and local levels; see Environmental Protection Agency Regulations and State Universal Waste Programs in the United States for more information.

Additional resources

General guidance

Previous Updates

Revisions made on October 26, 2021 include:

  • Added definition for aerosols and droplets
  • Added pneumatic tube guidance
  • Added shipping instructions

Revisions made on June 12, 2021 include:

  • Added new training resource for specimen packing and shipping

Revisions made on September 19, 2020 include:

  • New link under Resources to DLS Preparing and Supporting Laboratories Responding to COVID-19 page

Revisions made on August 7, 2020 include:

  • Standard Precautions

Revisions made on July 16, 2020 include:

  • Added DOT resources to Specimen Packing and Shipping and Resource section

Revisions made on July 13, 2020 to update:

  • Language for virus isolation

Revisions made on June 3, 2020 include:

  • Added anatomic pathology guidance for COVID-19
  • Updated Point-of-Care testing guidance for COVID-19

Revisions made on May 11, 2020 include recommendations for:

  • Point-of-Care testing guidance for COVID-19
  • Added information on PPE to the "General Guidance" section
  • Added Biological Risk Assessment: General Considerations for Laboratories resource to the "General Guidance" section
  • Added Core Infection Prevention and Control Practices for Safe Healthcare Delivery resources to the "General Guidance" section
  • Added OSHA Bloodborne Pathogens Standard resource to the "General Guidance" section
  • Added EPA-approved disinfectant for SARS-CoV-2 resource to the "General Guidance section
  • Added Environmental Protection Agency (EPA) regulations and State Universal Waste Programs in the United States | Hazardous Waste | US EPA resources to the "General Guidance" section
  • Added information on PPE to the "Anatomic Pathology" section
  • Deleted "Decentralized and Point-of-Care Testing" section and provided a link to the updated Guidance for SARS-CoV-2 Point-of-Care and Rapid Testing webpage
  • Added information on N95 respirator and disposable mask to "Procedures with a High Likelihood of Generating Droplets or Aerosols" section
  • Added language on avoiding cross-contamination to the "Environmental Testing" section
  • Add language on Animal Biosafety Level 3 (ABSL-3) practices during inoculation of animals with infectious wild-type SARS-CoV-2 virus to the "Virus Isolation" section
  • Added link for state EPA regulations to the "Laboratory Waste Management" section
  • Added links to the "Additional Resources" section
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Content Source:
National Center for Immunization and Respiratory Diseases; Coronavirus and Other Respiratory Viruses Division