CDC has an existing central mechanism called the International Laboratory Coalition to provide a broad spectrum of laboratory strengthening activities. The coalition consists of four organizations: Association of Public Health Laboratories (APHL), American Society for Clinical Pathology (ASCP), American Society for Microbiology (ASM), and the Clinical and Laboratory Standards Institute (CLSI). CDC has cooperative agreements with each of the organizations.

During FY 2010, Coalition partners APHL, ASCP, and ASM will provide technical assistance to the Government of Ukraine (GOU) in TB/HIV and laboratory strengthening. It is expected that these Coalition organizations will achieve the following outcomes by the end of the fiscal year:

National TB Reference Laboratory (NHRL) has strategic plans for: QA/QC of TB diagnostic testing and culture and for adequate training of laboratory staff at all levels of the Ukrainian national TB laboratory network; assuming reference laboratory functions for the Ukrainian national HIV laboratory network; and assuring adequate training of laboratory staff at all levels of the Ukrainian national HIV laboratory network

National TB Reference Laboratory has capacity in liquid-media culture

National TB Reference Laboratory has QA/QC and biosafety programs in place

Relevant National HIV Reference Laboratory staff received training in laboratory administration and QA/QC;

National HIV Reference Laboratory QA/QC systems are implemented in all 27 regions and achieve improved quality of laboratory testing; External Quality Assessment Schemes in place

National HIV Reference Laboratory's strategic plan for assuming reference laboratory functions for the Ukrainian national HIV laboratory network is operationalized

The International Laboratory Coalition's program directly contributes the achievement of two of Ukraine's forthcoming Partnership Framework goals and benchmarks: (1) improved quality and cost effectiveness of HIV prevention, care, and treatment services for MARPs; and (2) strengthened national and local ability to achieve Ukraine's National AIDS Program objectives. The International Laboratory Coalition will become more cost efficient over time through the leveraging of Global Fund resources and advocacy with the GOU to increase state funding for laboratory strengthening.

The International Laboratory Coalition also contributes to the USG strategy for health systems strengthening in laboratory systems, and national and regional leadership in health care. This is in line with Ukraine's National AIDS Program strategic goals and objectives, which include the national provision of TB and TB/HIV services as outlined in Ukraine's National TB Control Plan, 2007 -2011. In addition, these activities support the goals outlined in the MOH new strategy on counseling, testing and laboratory diagnosis which was released in July 2009.

Association of Public Health Laboratories (APHL): APHL is composed of leading public health laboratories and through its Global Health Program works to improve laboratory capacity worldwide. APHL has extensive experience and expertise in strengthening national reference laboratories and national laboratory networks, including management and strategic planning. Since 2004, APHL has worked to strengthen national reference laboratories and laboratory networks in multiple PEPFAR countries through successive cooperative agreements with CDC. APHL staff will assess the National HIV Reference Laboratory in H1 2010 (2009 funding) and develop a plan to build the capacity of the National HIV Reference Laboratory (NHRL) through trainings (especially in laboratory management and strategic planning) and the development of capacity in quality assurance/quality control systems, including for rapid testing as well as ELISA HIV diagnostics, CD4, viral load, hematology, and chemistry. APHL will work with the Ukrainian National HIV Reference Laboratory (NHRL) on EQAS (External Quality Assessment Schemes) to develop or purchase panels for proficiency testing on the national level for these tests.

APHL will also assist the NHRL with management training and to develop sound laboratory policies to help strengthen the tiered HIV laboratory system throughout Ukraine.

It is expected that APHL will achieve the following tangible outcomes by the end of the project:

National HIV Reference Laboratory (NHRL) has a strategic plan for assuming reference laboratory functions for the Ukrainian national HIV laboratory network

Train all relevant NHRL staff in laboratory administration

Train all NHRL staff in QA/QC

Implementation of QA/QC systems in all 27 regions

American Society for Clinical Pathology (ASCP): since August 2005, the ASCP Global Outreach Program has partnered with CDC to provide laboratory training and implement laboratory quality improvement initiatives in resource-constrained countries. ASCP provides in-service laboratory training to working laboratorians so that they may update skills in preparation for the use of new technologies that will enhance and improve the diagnosis and laboratory monitoring of HIV/AIDS patients.

Sustainability of this effort is provided through training of trainer (TOT) workshops, which develop master trainers from in-country senior laboratorians. ASCP also works to improve pre-service training for laboratory professionals in these new technologies. ASCP staff will build the capacity of laboratories in the Ukrainian HIV laboratory network through trainings and systems improvements. Based on the results of a laboratory assessment to be completed during the first half of 2010, ASCP staff will develop a strategic plan with leadership of the NHRL to build the capacity of the laboratory staff in the multi-tiered laboratory system through trainings in laboratory techniques, quality control, and other needed areas. ASCP will assist the staff of the NHRL to implement the plan. ASCP will also assess the Ukrainian laboratory technician training system and work the Ministry of Education and Science to develop a consensual workplan for the revision of curriculum to aid in teaching laboratory focused methods and courses.

It is expected that ASCP will achieve the following tangible outcomes by the end of the project:

National HIV Reference Laboratory (NHRL) has a strategic plan for assuring adequate training of laboratory staff at all levels of the Ukrainian national HIV laboratory network

Training of relevant laboratory staff resulting in improved quality of laboratory testing in all 27 regions

American Society for Microbiology (ASM): in Ukraine, tuberculosis is the most common serious opportunistic infection and is the leading cause of death from AIDS. Rapid and accurate diagnosis of tuberculosis is critical to reducing morbidity and mortality from HIV. Through previous USG and international support, the National TB Reference Laboratory has introduced liquid-media TB culture to speed diagnosis; however, major technical assistance needs remain in developing cost-effective liquid media use, quality assurance, and infection control. In FY 2010, the Ukraine program will begin to participate in an existing centrally managed contract with ASM to support development of technical capacity of personnel in the Ukrainian TB laboratory network and especially at the National TB Reference Laboratory. CDC has an existing central mechanism with ASM, whose technical experts strengthen microbiology services in multiple PEPFAR countries.

ASM technical experts (mentors) will provide in-country support for microbiology for tuberculosis, TB laboratory systems and strategic planning, standardization of protocols for cost effective testing, and good laboratory and clinical practices. ASM's major emphasis area will be to support technical and human capacity development in order to establish rapid quality-assured diagnosis of TB, including the introduction of liquid-media and molecular diagnosis, development of cost effective procedures for use of liquid-media, strengthening drug sensitivity testing (DST), and strengthening the TB external quality assurance program.

ASM supports activities designed to strengthen national HIV laboratory networks. The project receives funding in the technical area of laboratory strengthening. ASM will become more cost efficient over time through the leveraging of Global Fund resources and advocacy with the GOU to increase state funding for laboratory strengthening.

It is expected that ASM will achieve the following tangible outcomes by the end of the project:

National TB Reference Laboratory (NHRL) has a strategic plan for QA/QC of TB diagnostic testing and culture and for adequate training of laboratory staff at all levels of the Ukrainian national TB laboratory network

National TB Reference Laboratory has algorithms for cost-effective utilization of liquid-media culture and DST

National TB Reference Laboratory has QA/QC and biosafety programs in place