APHL is a central multicountry CoAg with the Association of Public Health Laboratories, supporting capacity development of the National HIV Reference Laboratory (NRL) and of a regional AIDS laboratory network in Ukraine. The NRL units have not functioned as a reference laboratory, have limited capacity, and are housed in inadequate temporary facilities. APHL assessed the NRL and developed a plan to build NRL capacity and support infrastructure improvements. MOH approval of implementation of the plan has been delayed due to restructuring of MOH and the HIV program; however, in January 2012, approval was given to major components of the plan. Recent steps included provision of international standards for development of new national laboratory standards and laboratory management training for leadership of the NRL and of the national laboratory quality improvement institute. APHL contributes to goals 2 and 3 of Ukraines Partnership Framework to improve quality and cost effectiveness of HIV services for MARPs and strengthened national and local ability to achieve Ukraines AIDS Program objectives. These activities also support the goals of the MOH strategy on counseling, testing and laboratory diagnosis released in 2009. APHL coordinates closely with GF on laboratory strengthening and advocacy for increased national funding for laboratory strengthening. All APHL activities are designed to increase national capacity and ownership. For example, all training plans include steps to lead to adoption of the material into some level of national training. Outcomes by the end of the project include a fully functioning NRL, training of relevant NHRL/network staff in laboratory administration and QA/QC, initiation of QA/QC systems and networking activities in all 27 regions.

In FY12 APHL will continue work to strengthen the HIV laboratory system in Ukraine, including activities to strengthen the National Reference Laboratory (NRL) and to develop the system of regional laboratories into a functional network. APHL has developed a plan based on assessment of the NRL for capacity development, especially in laboratory management, strategic planning, QA/QC systems, ELISA HIV diagnostics, CD4, viral load, hematology, clinical chemistry, network development, and infrastructure improvements. Activities to improve quality management will also include working with the Ukrainian Reference Center (UkRC- lead for introduction of laboratory standards) in the harmonization and implementation of ISO 15189 in Ukraine. FY12 funds will be used to initiate introduction of Laboratory Information Systems (LIS), specifically to develop technical specifications, procure and install Laboratory Information Systems in the NRL and three regional laboratories that have the highest workloads.

PEPFAR II indicators: These indicators (no. of testing laboratories and number of accredited laboratories) provide limited information for programming laboratory support in Ukraine. Currently, the number of testing laboratories in the HIV laboratory system is sufficient; however, quantitative capacity in some assays needs to be augmented and the qualitative capacity, especially human, of all laboratories needs to be strengthened. All laboratories in the system are nationally accredited except for the HIV National Reference Laboratory (due to its lack of adequate physical facilities); however, numerous gaps exist in quality management. APHL activities are addressing these gaps.

Coverage: Currently coverage with laboratory testing is adequate nationwide with the exception of prison populations. CDC is participating in planning for laboratory capacity augmentation under the GF Round 10 funding to cope with anticipated growth in needs and to extend coverage to prison populations; however, addl laboratories are not planned. As additional capacity is developed, APHL activities will include them into quality management and other support activities.

Training in management and quality assurance: these trainings are a major focus for APHL. Directors of the NRL and Ukrainian Reference Center had intensive laboratory management training in Oct-Nov 2011. Plans are being developed to conduct broader laboratory management training for a broader audience in Ukraine with involvement of a national training institute to allow for institutionalization.

All CDC-supported laboratory activities in Ukraine target enhancing the capacity of the MOH laboratory system.