Detailed Mechanism Funding and Narrative

Years of mechanism: 2012 2013 2014 2015 2016 2017 2018

Details for Mechanism ID: 13919
Country/Region: Kenya
Year: 2012
Main Partner: Clinical and Laboratory Standards Institute
Main Partner Program: NA
Organizational Type: NGO
Funding Agency: HHS/CDC
Total Funding: $300,000

1. Goals and objectives:Since 2008 Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB) has achieved considerable progress in the areas of regulating training of medical lab sciences, setting standards for examination and/or of medical lab practitioners, and regulating best lab practices and QA measures. As a result, the KMLTTB was recently given additional mandate of validating and registering medical lab equipment and reagents before they are put to use in Kenya. KMLTTB will also to establish an inspectorate for HIV testing labs to help in consolidating and reviewing/revising existing documentation for registration of HIV diagnostic and treatment related reagents. To enhance the on-going scale up of quality testing systems and accreditation of medical labs in Kenya, CDC Kenya has identified the CLSI to assist KMLTTB develop and implement guidelines and standards for validation and registration of laboratory equipment and reagents. This activity will capacity-built the KMLTTB secretariat and reference laboratories for validation activities. A mechanism to monitor continued vendor compliance to established standards will also be instituted. CLSI will provide technical assistance through training and technology transfer to KMLTTB to enhance their regulatory/registration functions in Kenya. 2. Coverage:This is a national activity that will ensure that Kenya has a competent medical laboratory workforce capable of providing quality laboratory services.3. Transition to country partners:The technical assistance will equip the KMLTTB competencies to sustain the regulation of both training and practice of medical laboratory science in Kenya. 4. Vehicles:There are no plans to purchase vehicles. This activity supports GHI/LLC.

Funding for Laboratory Infrastructure (HLAB): $300,000

Goals:

The Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB) was created in 1999 to ensure quality medical lab services by regulating training in medical laboratory sciences in all relevant training institutions. Through PEPFAR support, starting FY 08, KMLTTB has made significant achievements including: assessment of all relevant training institutions, establishing a national database for laboratory workforce, review of training curricula for professional training institutes and setting of standards for examination and registration of all practicing laboratory technicians and technologists. Through a recent subsidiary legislation by the Kenya parliament, the KMLTTB has been mandated to establish a system to register and ensure validation of equipment and reagents before they are put to use in Kenya. Related to this, KMLTTB is also mandated to establish an inspectorate for HIV testing laboratories that will review, consolidate, and revise existing documentation for registration of HIV diagnostic and treatment related reagents.In order to support the KMLTTB achieve its laboratory regulatory function and ensure quality laboratory practices, including HIV/AIDs diagnosis and management, CDC Kenya has identified the Clinical Laboratory Standards Institute(CLSI)-one of the HHS/CDC/International Laboratory Branch Co-Ag partners as a suitable partner, starting FY 2012. CLSI is known to support the development and application of easy-to-use guidelines and standards for laboratory testing and quality systems development. In addition, CLSI have demonstrated capacity to provide information, technical assistance, training and technical transfer for individuals and organizations to enhance effective service delivery in PEPFAR countries.

Objectives: In COP 2012 CLSI will implement the following activities:

Support development of policies for registration of medical laboratory reagents, test kits and equipment including HIV diagnostics.Support establishment of a system for validation and registration of all medical laboratory equipment and reagents in Kenya.Assist in identification and capacity building of local institutions to support validation activities and related tasks.Strengthen regulatory function of KMLTTB through training of laboratory inspectors and streamlining of application, verification and licensing processes.Establish systems for surveillance and monitoring of effectiveness of regulatory activities.

KMLTTB registered laboratory personnel are deployed at public and private health care facilities serving HIV-infected patients in all parts of the country. They deliver services related to HIV testing, monitoring of anti-retroviral and opportunistic infection therapy, assuring safe blood supplies, measuring the burden of HIV infection in populations and monitoring trends of the epidemic (surveillance). These functions are essential for the implementation and sustenance of all HIV /AIDS prevention strategies such as Counseling and Testing (HVCT), Prevention of Mother to Child Transmission (MTCT) and ARV treatment programs. The activity will also enhance the on-going laboratory accreditation process. The activity will have an in-built M&E component to inform progress and way forward.

Key Issues Identified in Mechanism
enumerations.Malaria (PMI)
Tuberculosis
Workplace Programs