Goals and objectives: A Global Healthcare Public Foundation (AGHPF) will continue to support laboratory accreditation efforts. A two pronged approach will focus on strengthening the regulatory framework through sensitization and advocacy of high level Ministry of Health and in particular the Dept. of Standards and Regulatory Services (DSRS) and Dept. of Diagnostics and Forensic services (DDFS) and to enable Kenya National Accreditation Services (KENAS) acquire international recognition as a formal ISO accrediting body. In the second and third years of PEPFAR funding, AGHPF took on cumulatively direct strengthening of thirteen laboratories through the WHO stepwise process towards ISO 15189 accreditation. This effort will continue. Additionally, 100 laboratory professional will be trained in quality systems management. Cost-efficiency strategy: AGHPF has instituted all interventions within Ministry of Health systems and garnered significant support from local authorities. This approach will ensure sustainability of this activity. The innovative SLMTA approach espouses laboratory improvements with resources available at facility level. Transition to country partners: AGHPF will work closely with local institutions including MOH-DSRS, MOH- DDFS and KENAS supporting institutionalization of accreditation activities. This partner has not used PEPFAR funds for vehicle purchase in the past and is not requesting funds for vehicle purchase in FY12.This activity supports GHI/LLC.

Under COP 12 AGHPF will continue to give direct support in laboratory quality improvement through SLMTA training and mentorship to nine Ministry of Health (MOH) and four Faith Based laboratories with the goal of attaining accreditation through the WHO-Step-wise process. Specifically, AGHPF staff experienced in laboratory quality systems will work shoulder-shoulder with MOH laboratory quality officers and managers to implement ISO 15189 standards at each laboratory. In addition AGHPF will conduct end term assessment of 10 laboratories, carry out accreditation sensitization and baseline assessments for 3 new laboratories and follow up with requisite SLMTA workshops. To support facility based improvement projects AGHPF will procure stationery items and minor essential laboratory supplies such as thermometers, timers, safety boxes, diamond pencils, signage and safety devices.

AGHPF will train 100 health care workers in biosafety, equipment /method validation, GCLP, internal audits and quality management systems taking a task-based approach at facility or regional level. This will ensure taught skills are implemented and that laboratory workers are not taken away from their routine service delivery duties unnecessarily.

Through support to the MOH Department of Standards and Regulation, AGHPF will strengthen Kenyas regulatory framework for laboratory accreditation. Kenya has up to 400 laboratories all of which cannot benefit from the accreditation initiative unless laboratory accreditation efforts are internalized within MOH structures and systems. AGHPF will work with MOH to facilitate an accreditation supportive environment.

AGHPF will also strengthen Kenya National Accreditation Service (KENAS) to attain international recognition by the International Laboratory Accreditation Cooperation (ILAC) and position itself to confer external objective accreditation of medical laboratories in Kenya. This will involve the conduct joint assessments with a recognized accreditation body such as South African National Accreditation System (SANAS). Prior to full accreditation, KENAS will assess laboratories using the WHO-AFRO checklist and award recognition stars. Specific activities with KENAS will include development of a national application clearing center, training of national laboratory assessors (14), printing and dissemination of the medical Laboratory accreditation services (MLAS) policy guide and checklist.

This cooperative agreement will be monitored by CDC Kenya through regular quarterly meeting to review progress on the work plan, compliance to the Notice of Award and USG regulations. It will be ensured that the MOH- National Laboratory Accreditation Committee guidelines are followed.

This activity will contribute directly to thirteen accredited laboratories in Kenya and training of at least 100 health care workers. The exact cost of improving laboratory quality through the WHO Step- wise accreditation process and of running a quality HIV management laboratory support service are not yet known. This activity will provide critical information for more accurate forecasting, planning and budgeting for laboratory support for program activities. MOH laboratory managers will acquire skills in developing facility budgets and advocating for a fair share of resources both centrally and at facility level.

Please see the partners overview narrative for information on the strategy to transition to local partners.