National Laboratory Planning: Developing Sustainable Biocontainment Laboratories in Limited Resource Areas

Abstract

Strategic laboratory planning in limited resource areas is essential for addressing global health security issues. Establishing a national reference laboratory, especially one with BSL-3 or -4 biocontainment facilities, requires a heavy investment of resources, a multisectoral approach, and commitments from multiple stakeholders. We make the case for donor organizations and recipient partners to develop a comprehensive laboratory operations roadmap that addresses factors such as mission and roles, engaging national and political support, securing financial support, defining stakeholder involvement, fostering partnerships, and building trust. Successful development occurred with projects in African countries and in Azerbaijan, where strong leadership and a clear management framework have been key to success. A clearly identified and agreed management framework facilitate identifying the responsibility for developing laboratory capabilities and support services, including biosafety and biosecurity, quality assurance, equipment maintenance, supply chain establishment, staff certification and training, retention of human resources, and sustainable operating revenue. These capabilities and support services pose rate-limiting yet necessary challenges. Laboratory capabilities depend on mission and role, as determined by all stakeholders, and demonstrate the need for relevant metrics to monitor the success of the laboratory, including support for internal and external audits. Our analysis concludes that alternative frameworks for success exist for developing and implementing capabilities at regional and national levels in limited resource areas. Thus, achieving a balance for standardizing practices between local procedures and accepted international standards is a prerequisite for integrating new facilities into a country's existing public health infrastructure and into the overall international scientific community.

Harmonization of Biosafety and Biosecurity Standards for High-Containment Facilities in Low- and Middle-Income Countries: An Approach From the Perspective of Occupational Safety and Health

“…In other words, we question whether there are any scientifically evaluated reasons for requiring installation of all those in the list developed with the view of advanced countries, where different risk assessment standards and factors apply. It is true that we cannot wait until basic conditions in LMICs are ready by themselves under current circumstance where there are no regulations or oversight to determine what should be prepared otherwise than SLIPTA to audit the progress (52).…”

“…This goes beyond the national, organizational borders of biosafety and biosecurity control frameworks, and high-containment laboratory capacity development is an integral part of ensuring early detection of outbreaks for the containment of epidemic-prone diseases in LMICs. However, again, central tracking authorities are currently absent from BSL-4 facilities around the world (52).…”

The Culture of Biosafety, Biosecurity, and Responsible Conduct in the Life Sciences: A Comprehensive Literature Review

“…A few articles focused on risk assessment and governance in new laboratory planning and development. 66,67 Of note, safety culture considerations were raised during the proposal, planning, and construction of the new biosafety level 4 (BSL-4) laboratory at Boston University and elsewhere. 68,69 In contrast to the nuclear domain, self-governance is an important characteristic of the life sciences, especially in regard to dual-use research.…”

Studies of Transgenic Mosquitoes in Disease-Endemic Countries: Preparation of Containment Facilities

“…Cost savings should not be assumed, as, in fact, new builds might more easily be fitted for containment (Crane and Kreitlein 2006 ). Renovation of numerous laboratories working with hazardous organisms and substances has been reported for Former Soviet Union sites and in response to the need for facilities during disease outbreaks in Africa (Yeh et al 2016 ). There has also been a successful short-term use of BSL-2 laboratories prefabricated in shipping containers and/or installed as modular units (Crane and Kreitlein 2006 , Germfree 2016 ).…”