The National Academies of Sciences, Engineering, and Medicine will produce a rapid expert consultation to examine considerations for integrating diagnostic services and systems within integrated, country-led health systems, with the goal of maximizing health impact given constrained resources. The consultation will focus on lessons learned and key trade-offs associated with transitioning from vertically funded disease-specific diagnostic programs toward integrated service delivery and laboratory systems while maintaining health impact, efficiency, and access to care.

Drawing on illustrative examples from HIV, tuberculosis, malaria, outbreak response, and other priority health programs, the consultation will identify evidence and lay out considerations that can inform country-level decision-making regarding the integration, deployment, and use of diagnostic services within integrated country-led, patient centered health systems – with a particular attention to how diagnostic choices translate into improved health outcomes. As the evidence allows, this consultation will address the following:
• Key considerations for integrating diagnostic services within health systems, such as policies, procedures, and guidelines needed to support transition from disease-specific to integrated services and systems, including testing location, service delivery models, workforce capacity, supply chains, quality assurance, efficiency, and access to care. To the extent feasible, considerations may be assessed against their contribution to health impact, including who is tested, for what conditions, and how resource allocation may affect health benefit.
• Operational and system-level trade-offs associated with integration, such as potential impacts on disease-specific diagnostic performance, continuity of care, and the ability to respond to disease-specific needs. To the extent feasible, this may include consideration of the cascade from testing to result to clinical action to treatment/prevention to health outcome.
• Lessons learned and key considerations from efforts to transition from disease-specific diagnostic programs to integrated service delivery and laboratory systems, such as approaches to maintain diagnostic performance, service continuity, and sustainability during transition (e.g., integrated sample transport systems, integrated data and surveillance systems, integrated quality improvement and accreditation systems, integrated supply chain systems, workforce). This will include consideration of what diagnostic capacity may be needed at different levels of the health system and the circumstances under which consolidation, decentralization, integration, retention of disease-specific capacity, or repurposing may yield greater impact, recognizing that integration may create efficiencies but may also perpetuate infrastructure built during a period of greater disease-specific financing. This may also include strategies to support accelerated implementation of existing integration policies and procedures, as well as examples of implementation science approaches that can inform how countries operationalize this transition.
• Emerging technologies and service delivery approaches that may facilitate integration, including decentralized testing, self-testing, multiplex platforms, and digital tools, and considerations for their adoption within country-led systems, including consideration of diagnostic yield, downstream clinical action, cost-effectiveness, and health outcomes.

Where feasible, this consultation should help identify impact-oriented metrics, such as cases detected that would otherwise have been missed, time to appropriate treatment, morbidity and mortality averted, transmission prevented, and cost per meaningful clinical outcome, to guide these considerations in place of volume-based measures.