A risk assessment is a process to evaluate the probability and consequences of exposure to a given hazard, intending to reduce the risk by establishing the appropriate mitigations and hazard controls to be used. A laboratory site- and activity-specific biological risk assessment should be performed to identify potential scenarios from its activities and procedures that could produce a negative outcome, such as exposure to infectious material. The risk assessment should prioritize the possible negative outcomes or risks based on evaluating the likelihood and consequences of each identified risk. Risk assessments should be performed to determine if additional or enhanced biosafety precautions are warranted based on situational needs, such as high testing volumes and the likelihood of generating infectious droplets and aerosols.
Risk assessments and mitigation measures depend on the procedures performed, identifying the hazards involved in the process and/or methods, the competency level of the personnel who perform the procedures, the laboratory equipment and facility, and the resources available. The risk assessment should determine the most appropriate control measures and how the system will measure their effectiveness.
All laboratories should routinely perform site-specific and activity-specific risk assessments to identify and mitigate risks, especially before introducing new testing, such as SARS-CoV-2 / COVID-19.
16. Gathany, J. (2020). "This Centers for Disease Control and Prevention (CDC) scientist was preparing to test a patient’s sample for SARS-CoV-2, using the CDC 2019 novel coronavirus (2019-nCoV) real-time reverse transcriptase (RT)–PCR diagnostic panel." CDC.gov. https://phil.cdc.gov/Details.aspx?pid=23897
