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The pervasive nature of infections causing major outbreaks have elevated biosafety and biosecurity as a fundamental component for resilient national laboratory systems. In response to international health security demands, the Global Health Security Agenda emphasizes biosafety as one of the prerequisites to respond effectively to infectious disease threats. However, biosafety management systems (BMS) in low-medium income countries (LMIC) remain weak due to fragmented implementation strategies. In addition, inefficiencies in implementation have been due to limited resources, inadequate technical expertise, high equipment costs, and insufficient political will. Here we propose an approach to developing a strong, self-sustaining BMS based on extensive experience in LMICs. A conceptual framework incorporating 15 key components to guide implementers, national laboratory leaders, global health security experts in building a BMS is presented. This conceptual framework provides a holistic and logical approach to the development of a BMS with all critical elements. It includes a flexible planning matrix with timelines easily adaptable to different country contexts as examples, as well as resources that are critical for developing sustainable technical expertise.

BackgroundThe Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist is used worldwide to drive quality improvement in laboratories in developing countries and to assess the effectiveness of interventions such as the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. However, the paper-based format of the checklist makes administration cumbersome and limits timely analysis and communication of results.Development of e-ToolIn early 2012, the SLMTA team in Vietnam developed an electronic SLIPTA checklist tool. The e-Tool was pilot tested in Vietnam in mid-2012 and revised. It was used during SLMTA implementation in Vietnam and Cambodia in 2012 and 2013 and further revised based on auditors’ feedback about usability.OutcomesThe SLIPTA e-Tool enabled rapid turn-around of audit results, reduced workload and language barriers and facilitated analysis of national results. Benefits of the e-Tool will be magnified with in-country scale-up of laboratory quality improvement efforts and potential expansion to other countries.

Introduction-Thailand conducted a national laboratory assessment of core capacities related to the International Health Regulations (IHR) (2005), and thereby established a baseline to measure future progress. The assessment was limited to public laboratories found within the Thai Bureau of Quality and Safety of Food, National Institute of Health and regional medical science centres.

The Global Health Security Agenda and the International Health Regulations (2005) recommend that countries strengthen the capacity of their national laboratory systems to comply with the International Health Regulations. To efficiently and effectively direct these efforts, the US Centers for Disease Control and Prevention—in collaboration with the Ministry of Health Directorate of Laboratories, the African Society for Laboratory Medicine, and Integrated Quality Laboratory Service—assessed Burkina Faso's national laboratory system using the World Health Organization Laboratory Assessment Tool . Based on gaps observed in biorisk management, the Biosafety and Biosecurity Laboratory Assessment Tool (BSS LAT) was developed to assess 10 public laboratories handling dangerous pathogens. This tool uses a specific scoring matrix with quantitative output. Composite assessment scores for the 9 primary modules (capacity areas) were reported, with the highest scores reported in cleaning, disinfection, sterilization, waste management (42%), and good laboratory practices (40%), and the lowest scores in biosecurity/biosafety (33%), documents/regulations (18%), emergency management (16%), and risk management (5%). To address challenges identified in the assessments, a set of activities was planned with a focus on biorisk management. Results from an evaluation conducted 1 year later, using the BSS LAT, showed an increase in the average score of all indicators from 25% to 45% and an increase in the biorisk management module score from 5% to 35%. This evaluation process was a decisive step toward strengthening the capacity of the laboratory system in Burkina Faso. Global Health Security Agenda investments and activities have made a lasting impact on improving biosafety and biosecurity in public health laboratories. To ensure sustainability, a strong laboratory quality management program based on a mentorship system is greatly needed.