This is a new award / mechanism with single eligibility for the Ethiopian Health and Nutrition Research Institute (EHNRI), which has the national leadership role of overseeing laboratory services, coordination, implementation and knowledge transfer for health-related research, survey and surveillance activities and public health emergency management. EHNRI has established a 5 year integrated laboratory master plan (2009-2013). EHNRI will provide standardization of laboratory services, targeted training programs, integrated of services, regional laboratory capacity development, improvement of commodity procurement and distribution, strengthening and expansion of national laboratory quality systems, equipment maintenance services, laboratory networking and sample referral, deployment of data management system, laboratory workforce development, mentorship and evaluation of better technologies. EHNRI also provides the guidance for establishment and implementation of laboratory accreditation including the WHO/AFRO accreditation. EHNRI developed a 5 year (2010-2014) strategy for HIV surveillance which is currently being implemented. EHNRI requires considerable capacity building support from PEPFAR to operationalize this strategy. EHNRI conducts ANC-based HIV surveillance every two years and sample collection has been finalized for this round. EHNRI played an important role in DHS+ and national TB surveillance activities. TB/HIV surveillance has been completed in 60 sentinel sites and preparation is underway to expand to more sentinel sites. Data collection will start soon for MARPS, STI syndromic and etiology based surveillance. The national TB drug resistance survey that is currently underway, is showing good progress and will be finalized in FY 13.

In COP 2012, EHNRI started implementation of the second round of national anti-TB drug resistance surveys at 32 sites. This survey will also determine the prevalence and pattern of anti-TB drug resistance among HIV co-infected TB patients as a sub-component. Currently more than two thirds of the required samples and data have been collected. EHNRI has supported establishment of six TB culture facilities at regional labs and MDR treatment hospitals. Currently two facilities are providing services and an additional two facilities will start providing service early in FY13. In COP 2013, EHNRI will finalize the second round national drug resistance survey, analyze the data and disseminate the findings. EHNRI will make all necessary preparations including site assessment and selection, material procurement, and training to undertake rapid XDR-TB surveillance. In COP 2013 EHNRI will closely monitor and maintain functionality of the existing TB culture and DST, including molecular diagnostic technique services. EHNRI will leverage resources to expand GeneXpert MTB/RIF to high case load facilities and lead validation of new TB diagnostic techniques for adoption for local use. Resources will be coordinated with the Global fund and other non-PEPFAR TB partners to procure GeneXpert equipment, as well as maintenance, calibration and training. EHNRI will work with regional laboratories for quantification, procurement and ensuring uninterrupted supply for AFB and fluorescent microscopy, and culture, DST and molecular diagnostic services. EHNRI will work with regional laboratories to strengthen the laboratory network for TB diagnosis, establish integrated sputum transportation, scale up TB microscopy EQA to more sites in a decentralized approach, prepare panels for TB EQA, and make regional visits. In collaboration with HHS/CDC, EHNRI will introduce AFB microscopy EQA management software for panel and blinded rechecking.

This is a continuing activity from a previously ended Cooperative Agreement. Preventive and curative equipment maintenance plays a critical role in ensuring quality laboratory testing. EHNRI has developed a comprehensive equipment maintenance strategy incorporating issues related to equipment management in line with the Maputo Declaration. In COP 2012, EHNRI maintenance engineers provided curative maintenance services for ART monitoring instruments. Several spare parts have been ordered to be procured for repair and scheduled maintenance of ART equipment. Recently, EHNRI has started to engage RHBs to decentralize equipment maintenance roles to the regions. In COP2013, EHNRI will continue building local capacity for the preventive and curative maintenance of major and ancillary equipment. Capacity for certification of biosafety cabinets will be established at the central level. Purchase of spare parts and tools for local engineers will continue to build regional equipment maintenance capacity and maintenance service agreements will be established with vendors. EHNRI will work with other agencies in MOH to harmonize and implement equipment management policies. EHNRI has supported the implementation of LIS in 19 sites. An evaluation has been conducted and discussions are undergoing to integrate LIS with EMR. In COP 2013, LIS will be expanded to select facilities, and alternative open source LIS systems like basic LIS (BLIS) software will be used in other low-volume sites. Integrated external quality assurance activities have been expanded to more sites. EHNRI will continue to expand the national EQA to more sites with special emphasis on regional capacity building to run regional EQA. WHO/AFRO step-wise laboratory accreditation was implemented in 45 laboratories. In COP 2013, a total of 55 laboratories will be enrolled. For sample referrals, there is an agreement with the Ethiopian Postal System for DBS nationally, for all samples in Addis Ababa city, and also at some select sites in Amhara region. This will be further strengthened with the addition of TB and viral load samples. Microbiology laboratory services will be strengthened and there will be ongoing evaluation of better diagnostic technologies for local adaptation.

In prior years, EHNRI conducted ANC-based HIV surveillance at115 sentinel sites and the report has been recently released. Assessment of PMTCT program data has been completed in 43 selected PMTCT/ANC sites which helped with understanding data quality, uptake of HIV testing and completeness of information. EHNRI has also developed a TB/HIV surveillance system which was successfully implemented in 60 sentinel sites. The system generated important information on seven indicators of TB/HIV and will be expanded to more than 110 new priority sites. The preparation for STI etiologic and syndromic case surveillance system establishment has been finalized and data collection will be started in select pilot sites in Addis Ababa, Amhara and Oromia in COP 2013. Subsequently, data analysis and dissemination will take place. Regarding the STI etiologic agent surveillance, the survey on men with urethral discharge syndrome, female CSWs, and family planning attendees with genital infections assessment, is also expected to be started in COP 2013. EHNRI is implementing the 2012 round of ANC-based HIV surveillance at 116 sites and will also evaluate the BED and serial algorithm assay to estimate recent HIV infection. PMTCT data assessment will also be done at 80 ANC/PMTCT sites immediately after ANC surveillance. This will help track improvements in the uptake and data quality of the PMTCT program. EHNRI will also provide TOT for national and regional TB/HIV and STI surveillance activities with periodic site supervision. Regions and sentinel sites will be supported in data collection, analysis and use. EHNRI will continue to collaborate with HHS/CDC and WHO to strengthen the HIV drug resistance surveillance system. This includes carrying out the early warning indicator survey for patients on ART, a drug threshold survey on HTC/ANC clients, and prevention cohort monitoring on newly enrolled ART clients in at least four sites. In collaboration with Ethiopian Public Health Association, EHNRI will host, lead and guide the surveillance of HIV cases among most at risk (MARP) populations. In collaboration with EPHA and Addis Ababa University School of Public Health, EHNRI will strengthen coordination of EFTP. In collaboration with other PEPFAR partners, EHNRI will conduct service provision assessment (SPA); host and lead advanced clinical monitoring ( ACM).