A framework for evaluating biosafety and biosecurity in national network of biosafety level-3 laboratories in India: an initiative under national one health mission

Due to emergence and re-emregence of various infectious diseases across human, animal, wildlife, and environmental sector, there is rapid expansion of high containment Biosafety level 3 (BSL-3) laboratories in India under National One Health Mission. Although, the strong regulatory framework for BSL-3 laboratories exists in India, there is no standard tool to assess the compliance of these laboratories to biosafety and biosecurity parameters, assess staff competencies, sample archival & disposal and reporting processes. In view of this, the critical need was realized to develop a standard assessment tool to periodically assess the performance of BSL-3 laboratories. The tool includes specific sections with reference to a scoring checklist that assesses staff and training, sample handling and transportation, sample processing and testing procedures, data management and reporting, biomedical waste management, emergency preparedness and response, as well as general biosafety. The tool has been developed based on the strategies of the DBT-ICMR guidelines for establishment and certification of BSL-3 laboratories, International Health Regulations and Global Health Security Agenda. It is aimed to evaluate the preparedness of BSL-3 laboratories for safe and prompt testing during outbreaks ensuring the standards of biosafety and biosecurity are followed with the efficient sample processing and reporting. It has a potential to be adopted and used globally by various BSL-3 laboratories and auditors across the world.