Considerations for Laboratory Biosafety and Biosecurity During the Coronavirus Disease 2019 Pandemic: Applying the ISO 35001:2019 Standard and High-Reliability Organizations Principles.

Risk assessment is a critical tool for evaluating emerging pathogens such as severe acute respiratory syndrome coronavirus 2 because of the limited available information about pathogens and the diseases they cause. Industries adopt unique frameworks for risk assessment, for example, the ISO 35001:2019 biorisk management for laboratories and other related organizations provide tools to identify, assess, control, and monitor risks associated with hazardous biological materials. Industries such as aerospace are known as high-reliability organizations (HROs) because these must balance high-risk operations with minimal catastrophic outcomes. HROs focus on five core principles: preoccupation with failure, reluctance to simplify, sensitivity to operations, resilience, and deference to expertise to evaluate and manage risk. In the present discussion, practices described in the ISO 35001 standard and the HRO model are applied to the current challenges faced by laboratories worldwide. Laboratories processing known or unknown coronavirus disease 2019 (COVID-19) samples, testing COVID-19 vaccine candidates, propagating severe acute respiratory syndromeassociated coronavirus-2, or validating diagnostic assays benefit from implementing such practices. Principles extrapolated from the HRO also help illustrate the importance of the end-to-end processes to ensure successful outcomes. Workplace safety is enhanced by the involvement of all stakeholders, from top leadership to front-line workers. High-quality outcomes as measured by a lack of incidents, accidents, injuries, or near misses are the positive consequences of strictly following standard operating procedures and timely communication of risks and pitfalls. Adopting a systematic framework to identify and manage risks posed by emerging pathogens results in increased workplace safety and higher quality processes and products.