Detailed Mechanism Funding and Narrative

Details for Mechanism ID: 12063
Country/Region: Kenya
Year: 2010
Main Partner: A Global Healthcare Public Foundation
Main Partner Program: NA
Organizational Type: Implementing Agency
Funding Agency: HHS/CDC
Total Funding: $500,000

"Identified in August 09 Reprogramming". This cooperative agreement with A Global Healthcare Public Foundation (AGHPF) was awarded in FY2009 from FOA PS09-965. (An award to Management Sciences for Health was also made from this same FOA PS-09 965). The activity was written into COP 09 as a TBD for Laboratory Training (mechanism ID: 10243.09, mechanism system ID: 10243). The TBD was declared to OGAC in August 2009 reprogramming with a prime partner name "FOA PS09-988 PRIME PARTNER 2" because the official notice of award to AGHPF had not been issued at that time. This mechanism is now being submitted in COP 10 as a continuing implementing mechanism with request for a new mechanism system ID.

OBJECTIVE: A Global Health Public Foundation (AGHPF) will continue to strengthen the national regulatory framework to institutionalize laboratory accreditation within Kenya government structures including ministries of health, medical regulatory boards and the Ministry of Trade and Industry under which the Kenya Bureau of Standards and Kenya Accreditation Services (KENAS) fall. Laboratory services are an essential component in the diagnosis and treatment of HIV and other related diseases of public health significance, including malaria and tuberculosis (TB). The laboratory infrastructure for HIV, malaria, and TB testing and quality assurance remains weak in Kenya. There is urgent need to strengthen quality laboratory services. Establishment of an accreditation system will help Kenya improve and strengthen the capacity of labs in an integrated manner. Acquiring accreditation through ISO and CAP is expensive and unattainable for most laboratories in developing countries. A recent survey revealed that out of 340 accredited labs in Africa 92% are in South Africa and only 10% of them are in the public sector. WHO-AFRO has established an affordable five-step accreditation process.

PROJECT STATUS: In FY 09, AGHPF began sensitizing ministries of health, medical regulatory boards, external quality assurance providers and accrediting bodies on the WHO step-wise accreditation plan. KENAS will be strengthened to become the national laboratory accrediting body.

KEY ACTIVITIES: In FY10 KENAS will be strengthened to become the national laboratory accrediting body. Other activities will include finalization of the national lab accreditation plan, training and mentorship of eight laboratories and accreditation of six laboratories. AGHPF will strengthen the regulatory framework to support national laboratory accreditation implementation by working with MOHs, WHO, KENAS, Kenya Medical Laboratory & Technologists Board (KMLTTB) and Kenya Medical Practitioners and Dentists' Board (KMP&DB) to establish and monitor national laboratory standards. A system for on-going inspection, continuing professional development and certification of labs will be supported. Refresher training for 20 laboratory assessors for WHO accreditation scheme will be conducted. Key deliverables will include a functional local laboratory accrediting body, trained laboratory assessors, a system for monitoring lab professionals' continuing education and proficiency and government support for laboratory accreditation.

Funding for Laboratory Infrastructure (HLAB): $500,000

The PEPFAR/Kenya laboratory program aims to strengthen sustainable and integrated laboratory network systems in order to provide quality diagnostic tests to meet PEPFAR goals for prevention, treatment, and care of people living with HIV/AIDS. The Government of Kenya (GOK) Medical Laboratory Strategic Plan aims to strengthen quality medical laboratory practice. A long-term goal of technical assistance to national laboratory programs is to develop national laboratory quality assurance programs. Over the past five years, PEPFAR has supported approximately 70 laboratories and about 1,500 HIV testing sites. In FY09 a Quality Management Systems (QMS) plan to ensure that laboratory testing is accessible, accurate, reliable and timely was developed. In FY 10 Kenya will focus on improving quality practices at these laboratories and lead 21 of them to accreditation based on WHO/CDC standards over the next three years. A Global Healthcare Public Foundation (AGHPF) will support GOK to establish a national laboratory accreditation system to implement the QMS plan through a regulatory framework led by the Department of Standards and Regulation (DoR&S) at Ministry of Health. Kenya National Accreditation Services (KENAS) will be strengthened to develop standards and criteria for medical laboratories in conformity with international accreditation standards. Thirty laboratory assessors will be trained. This will facilitate conduct of laboratory assessments and certification of laboratories. KENAS is an autonomous body under the aegis of Ministry of Trade and Industry dedicated to operating a regional wide, broad spectrum accreditation system.

Medical professional regulatory bodies including Kenya Medical Laboratory & Technologists Board (KMLTTB) and Kenya Medical Practitioners and Dentists' Board (KMP&DB) will be strengthened to certify medical laboratory personnel. Programs for continuing professional development and certification will be supported. National standards for laboratory infrastructure, safety, testing, personnel and quality assurance directed toward accreditation of medical laboratories will be developed. Laboratories will be evaluated in a step-wise process towards full laboratory accreditation using scores on the checklist. A measure of number of laboratories accredited will provide critical information for accurate forecasting, planning and budgeting for laboratory support for PEPFAR program activities. Support for KENAS, KMLTTB and KMP&DB and engagement of the MOH will support the PEPFAR II goal of transition of laboratory services to local in- country partners and result in sustainable accredited laboratories.

This activity supports national systems by targeting policy makers at the Ministries of Health (DoR&S, KMLTTB, KMP&DB), and Ministry of Trade and Industry (KENAS). These stakeholders will be instrumental in effecting regulatory requirements for accreditation of laboratories.

The number of accredited clinical laboratories, the progress of a laboratory towards accreditation, and the laboratory's ability to maintain accreditation over time provides documentation that the laboratory has the capability and the capacity to perform quality-assured clinical laboratory testing for HIV diagnostic and care and treatment services. Maintaining accreditation is a continuous process and can serve as a measure of sustainability and Health Systems Strengthening. It is anticipated that quality laboratory systems will lead to improved quality across multiple health departments including clinical care and pharmacy.

AGHPF will support WHO step-wise laboratory accreditation through training of 30 lab assessors, development of CPD certification programs for laboratory professionals, and development of national medical laboratory accreditation standards. These initiatives will build local indigenous capacity, lower marginal costs and promote sustainability.