Lab Matters Spring 2020 | Page 16

FROM THE BENCH Risk Assessment in Action: Applying Risk Assessment Concepts to Safely Test Patients with COVID-19 By Drew Fayram, MS, RBP(ABSA), biological threat coordinator and biosafety officer, State Hygienic Laboratory at the University of Iowa Laboratory science, especially in the clinical and public health diagnostic laboratory, includes inherent and unavoidable risk to the health and safety of staff performing the work. The ongoing COVID-19 pandemic presents a new risk to laboratory staff, one which causes uncertainty in even the most seasoned of scientists. While risk can never be nullified, performing a biosafety risk assessment can help minimize the risk as much as possible and facilitate communication of risks and expected biosafety behaviors in the laboratory. Here is an overview of the risk assessment process to identify and mitigate risks for handling specimens from patients with COVID-19. Identify Hazards Laboratorians working with specimens that potentially contain SARS-CoV-2 should be aware of the characteristics of the virus, including sources of virus, persistence in the environment, and susceptibility to chemical disinfectants, among others. They should also be aware of the symptoms of COVID-19 so they can effectively self-monitor after working with these specimens. Note: it is important to also assess other biological and non-biological hazards associated with the work being performed, but for conciseness I’m focusing only on SARS-CoV-2. Evaluate Risk When evaluating risk, discuss the likelihood that the scientist will be exposed based on the procedures that will be performed, as well as the consequence of that exposure. For SARS-CoV-2, exposure to infectious droplets produced during specimen manipulation, testing and waste handling is thought to be the primary route of laboratory exposure. This may occur during routine procedures, like vortexing, mixing, centrifuging and other common laboratory tasks, or during an unforeseen incident like a splash or spill. Implement Controls Review Risk Assessment The severity of COVID-19 can range from asymptomatic infection to severe illness and, in a small percentage of cases, death. In this case, it is essential to consider the health status of staff who will be performing testing and tailor the risk evaluation to the needs of that group or individual. Mitigate Risk BIOSAFETY RISK ASSESSMENT CYCLE Mitigate Risk Figure 1. Biosafety Risk Assessment Cycle Identify Hazards Evaluate Risk Biosafety risk assessment is a subjective process that looks different at every organization, with different personnel, and when performing different procedures. While risk assessment guidance is helpful, it is impossible for anybody outside your laboratory unit to independently do a risk assessment for you. Every organization must perform its own site-specific and activity-specific risk assessments to determine whether enhanced biosafety precautions are warranted. Reduce risk as much as possible by developing a risk mitigation strategy to help identify the safety precautions and control measures needed to mitigate the risk. The National Institute for Occupational Safety and Health’s (NIOSH) Hierarchy of Controls shows how to prioritize the most effective mitigation strategies, to ensure we are implementing the most effective strategies first. Importantly, elimination and substitution are almost never realistic mitigation strategies in clinical and public health diagnostic laboratories. For specimens containing SARS-CoV-2, it is considered best practice to perform specimen manipulations in a certified Class II Type A2 biological safety cabinet, or to use a combination of other engineering controls (e.g., splash screen) and PPE to protect the scientist from exposure via the mucous membranes. Also, don’t overlook the importance of administrative controls, which emphasize biosafety behaviors and habit, like performing hand hygiene before leaving the laboratory. Implement Controls Controls may need to be procured or otherwise made available to staff for implementation. When preparing to implement controls, it is first essential to identify whether staff have sufficient knowledge and training to use the controls effectively. For this reason, it is best to assess the biosafety competency of staff. APHL and CDC’s Guidelines for Biosafety Laboratory Competency is a great resource for learning more about biosafety competency assessment. If competency is found to be inadequate, training should be conducted prior to implementing controls to ensure all staff are prepared to practice good safety behaviors. Review Effectiveness of Controls and Overall Risk Assessment Once controls have been implemented, the effectiveness of the risk mitigation strategy should be discussed. How effective does the group feel the strategy will be? Risk will most commonly be reduced by decreasing the likelihood of an exposure, as it is more difficult to reduce the consequence (severity of disease). Provide a mechanism for staff 14 LAB MATTERS Spring 2020 PublicHealthLabs @APHL