The focus countries have generally accepted the WHO guidelines on minimal basic laboratory requirements for initiating and monitoring ART (Gilks et al., 2006; WHO, 2006d). All focus countries have at least one functioning laboratory that can provide these essential services in a tertiary site. However, these services are not uniformly available in secondary treatment sites (provincial medical centers), are seldom available in primary sites (district medical centers), and are generally lacking in outlying rural areas in every focus country. This situation further limits the achievement of PEPFAR’s treatment goals.
PEPFAR’s stated goal for laboratory activities and infrastructure is to establish and support national quality-assured networks of tiered laboratory services that provide clear lines of authority and organization for the development of national laboratory policies, quality assurance programs, and standardized training and testing. PEPFAR’s approach is to promote the early establishment and regular reinforcement of local referral networks both within and among implementing partners. According to 2007 PEPFAR planning direction (OGAC, 2006e), the laboratory components of Country Operational Plans should emphasize implementing partner efforts to
Standardize laboratory best practices and provide related training.
Provide for uniform quality assurance measures among laboratories.
Provide for common equipment and supportive maintenance testing.
Support a unified approach to procurement and distribution of laboratory commodities.
A previous Institute of Medicine committee recommended that donors and program managers plan and budget for laboratory activities that can foster more accurate and effective HIV diagnosis and management, using WHO’s 2003 guidelines as the initial template (IOM, 2005). PEPFAR’s Adult Treatment Technical Working Group advised that the focus of PEPFAR-funded laboratory services should be to support ART, and that funding and activities for laboratory services should therefore be related primarily to supporting patients at sites where they are treated. In addition, the working group advised that laboratory services should demonstrate the adequacy of physical infrastructure, trained staff, equipment, supplies, reagents, and quality assurance for diagnosing and treating HIV and opportunistic infections and evaluating drug toxicities. The working group recommended that PEPFAR promote and support a tiered, public health–focused laboratory network as part of the national laboratory strategy (OGAC, 2006h).