A Multilingual Tool for Standardized Laboratory Biosafety and Biosecurity Assessment and Monitoring.

Control of infectious diseases requires the handling of infectious materials by both clinical and public health laboratories with exposure risks for laboratory personnel and environment. A comprehensive tool for assessing the capacity to manage these risks could enable the development of action plans for mitigation. Under the framework of the Global Health Security Agenda action package for biosafety and biosecurity, the authors developed a tool dedicated to assessing laboratory biosafety and biosecurity. The Biosafety and Biosecurity Laboratory Assessment Tool (BSS LAT) assesses the status of all laboratory biosafety core requirements across 10 different modules. It consists of a standardized spreadsheet-based tool that provides automatic scoring. It is designed to support national, regional, and global efforts to strengthen biosafety in clinical, public health, and veterinary laboratories. The BSS LAT was first used in Burkina Faso in collaboration with the African Society for Laboratory Medicine and the US Centers for Disease Control and Prevention to support the country in strengthening their biorisk management system. Since then, it has been successfully used in other countries (ie, Armenia, Burundi, Cameroon, Ghana, Guinea, Kazakhstan, Liberia), various settings (medical and veterinary laboratories), and translated into several languages (eg, English, French, Russian). The BSS LAT is a multipurpose tool that assists with standardization of biosafety and biosecurity requirements for all laboratories working with infectious materials, serves as a self-assessment guide for laboratories to develop improvement plans and reinforce capacities, and serves as a training guide for individual laboratories and networks or at the national level. The BSS LAT can also be used as a monitoring tool for the assessment of biosafety and biosecurity across all laboratories working with infectious materials at the national, regional, and global levels.

National Biosafety Management System: A Combined Framework Approach Based on 15 Key Elements.

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.

Field Epidemiology and Laboratory Training Program, Where Is the L-Track?

Background: Modifications of the Field Epidemiology Training Program (FETP) curricula to include a laboratory track (L-Track), to become Field Epidemiology and Laboratory Training Program (FELTP), began in 2004 in Kenya. The L-Track offered candidates training on laboratory competencies in management, policy, quality systems, and diagnostic methods as well as epidemiology, disease surveillance and outbreak response. Since then several FELTPs have discontinued the L-Track and instead offer all candidates, epidemiologists and laboratorians, a single FETP curriculum. Reasons for these changes are reported here. Methods: A questionnaire was sent to directors of 13 FELTP programs collecting information on the status of the programs, reasons for any changes, basic entry qualifications, source institutions and where residents were post enrollment or after graduation. Data from previous CDC internal assessments on FELTP L-Track was also reviewed. Results: Out of the 13 FELTPs included, directors from 10 FELTPs sent back information on their specific programs. The FELTPs in Kenya, Mozambique, Cameroon and Kazakhstan and Mali have discontinued a separate L-Track while those in Ghana, Georgia, Nigeria, Rwanda, and Tanzania continue to offer the separate L-Track. Reasons for discontinuation included lack of standardized curriculum, unclear strategies of the separate L-Track, and funding constraints. Two countries Kenya and Tanzania reported on the career progression of their graduates. Results show 84% (Kenya) and 51% (Tanzania) of candidates in the FELTP, L-Track were recruited from national/regional medical health laboratories. However post-graduation, 56% (Kenya) and 43% (Tanzania) were working as epidemiologists, program managers, program coordinators, or regulatory/inspection boards. Professional upward mobility was high; 87% (Kenya) and 73% (Tanzania) residents, reported promotions either in the same or in new institutions. Conclusions: The FELTP L-Track residents continue to offer critical contributions to public health workforce development with high upward mobility. While this may be a reflection of professional versatility and demand of the FELTP graduates, the move from core laboratory services underscores the challenges in filling and retaining qualified staff within the laboratory systems. Results suggest different strategies are needed to strengthen laboratory management and leadership programs with a clear focus on laboratory systems and laboratory networks to meet current and future clinical and public health laboratory workforce demands.