Management System Approach for Addressing Biosafety and Biosecurity of Emerging Pathogens in a Biosafety Level-3 Core Facility.

The biosafety level-3 (BSL-3) core facility (CF) at Yong Loo Lin School of Medicine (NUS Medicine) in National University of Singapore (NUS) has adopted international standards and guidelines to establish a biorisk management (BRM) system that helps to improve its BRM system and consistently minimize the risks to employees, the public, and the environment to an acceptable level while working with SARS-CoV-2. When the NUS Medicine BSL-3 CF started its operations, the Occupational Health and Safety Assessment Series 18001:2007 and the CEN Workshop Agreement 15793:2011 guidelines were used to establish its first BRM framework. The BRM framework provided the roadmap of how to organize, systematically manage, and structure the various biorisk programs that was then modified according to International Organization for Standardization 35001:2019 during the coronavirus disease 2019 pandemic in 2020 to address the specific circumstances. Adopting a management system approach allowed BSL-3 CF to efficiently manage its BRM even during unpredicted emerging pandemic situations. It resulted in integrating a risk management process into daily laboratory operations and ongoing identification of hazards, prioritization of risks, and the establishment of risk mitigation measures specific to SARS-CoV-2. In addition, the implementation of a BRM system in the BSL-3 CF has increased biorisk awareness among BSL-3 CF users and encouraged every stakeholder to take ownership of their activities, and continual improvements in mitigation of biorisks. This article summarizes the systematic approaches and major elements of the BRM systems adopted by NUS Medicine BSL-3 CF for the implementation of biosafety and biosecurity precautions, and control measures to minimize the risk of research activities using various RG3 biological agents including SARS-CoV-2.