1. LIST OF RELATED ACTIVITIES This activity relates to activities in HIV Treatment: ARV drugs (#6989) and Laboratory Infrastructure (#6990).

2. ACTIVITY DESCRIPTION This is a follow-up to the JSI activity from FY 2006. This component will continue to strengthen, improve and maintain the national logistics and distribution system for HIV clinical care and support and the prevention of TB. Through system strengthening, training and monitoring, the National Leprosy and Tuberculosis Program (NLTP) will be enabled to improve case detection rates, establish Diagnostic Counseling and Testing (DTC) and provide integrated TB/HIV treatment and referral. Under the KEMSA support, RPM Plus proposes to continue supporting Central NTLP and peripheral NTLP activities and at the same time, develop plans to capacitate NTLP to assume key administrative and operational activities. As with other MOH programs and services which have continued to request technical support for quantification and forecasting, KEMSA has also expressed a need in these areas. Specifically, KEMSA would benefit from greater knowledge and skills in quantification and forecasting so as to move away from annual historical projections for commodities that contribute to perennial stock outs and/or over supply. RPM Plus will work collaboratively with KEMSA and its clients to provide training and tools in quantification to KEMSA's central unit, depots and MOH departments that KEMSA serves. RPM Plus will work with KEMSA to assist in planning for distribution of medicines and supplies needed for key health campaigns and provide support during emergencies as necessary and when requested by the MOH or partners.

In 2005, 108,533 active cases of tuberculosis were notified to the NLTP. National HIV/TB co-infection rate stands at between 50-60%. Provincial and District TB and Leprosy Coordinators need to have access to not only TB drugs but also HIV tests for DCT, and prophylaxis treatment regimes such as cotrimoxazole. These integrated HIV commodities will be added into the TB logistics system so as to provide a fully integrated TB/HIV service. Tight financial management and accountability is the key to the success of the program as can be seen through present efforts as well as the TB program on which this program design was based

2. CONTRIBUTIONS TO OVERALL PROGRAM AREA This activity will support the distribution and logistics systems for equipment, supplies (such as laboratory equipment and pharmaceuticals including cotrimoxazole and isoniazid), and training necessary to implement the National TB program for integrated TB/HIV activities. Targets for patients treated as a result of these activities are listed under the activities funded through the NLTP and other partners collaborating in the implementation of integrated TB/HIV activities.

3. LINKS TO OTHER ACTIVITIES This activity also relates to activities in ARV drugs (#6989) and Laboratory Infrastructure (#6990), which concentrate on improving logistics for the various HIV/AIDS related commodity groups from condoms, home-based care kits, laboratory equipment and reagents to other associated health commodities.

4. POPULATIONS BEING TARGETED The beneficiaries are people living with HIV/AIDS.

5. EMPHASIS AREAS The major emphasis area for this component is logistics serving to enhance the availability of anti-TB drugs. Minor areas of emphasis include quality assurance and support supervision and training.

RPM/PLUS with additional PlusUp funds will continue support to the NLTP related to enhancing MDR-TB surveillance by: 1) Strengthening of the laboratory and clinical infrastructure to better monitor MDR TB; and 2) Supporting the logistics of ensuring specimen collection and delivery to the Central Reference Laboratory and feedback of results to the sending site and also enhancing supervision by PTLCs and DTLCs ($1,000,000).

1. LIST OF RELATED ACTIVITIES This activity relates to HLAB (#6990) and TB/HIV (#8713) services implemented by MSH/RPM+, the ARV procurement contract to be awarded by USAID through a mission competitive procurement (#6997), and HLAB (#8763), MTCT (#8757) and HVCT (#8783) activities by SCMS.

2. ACTIVITY DESCRIPTION Management Sciences for Health/Rational Pharmaceutical Management Plus (MSH/RPM Plus) will do forecasting and quantification of antiretroviral drugs and other pharmaceuticals, as well manage a logistics management information (LMIS) system to track procurement, warehousing, and distribution of these commodities. Specifically, RPM Plus will continue to support overall ART and other HIV/AIDS-related medical and pharmaceutical commodity supply requests from Emergency Plan partners, institutions, and assist the USAID ARV procurement contractor with appropriate procurement requests and distribution planning for ART Sites. RPM Plus will continue to assist with provision of strategic information from ART and other commodity sources including importers and manufacturers. At the national level, RPM Plus will provide technical assistance in commodity management to the USAID ARV procurement contractor, KEMSA, NASCOP and the Department of Pharmaceutical Services to strengthen commodity supply chain systems supporting ART and other medical and pharmaceutical commodities related to HIV/AIDS. To assist in capacity building for commodity management, RPM Plus will continue to implement curricula for training ART healthcare workers at all levels of care. RPM Plus will also strengthen systems by developing and applying Standard Operating Procedures for commodity management tools.

The major change in the 2007 COP implementation period is that RPM Plus will work more directly with KEMSA and its staff at the Logistics Management Unit (LMU) in order to support their activities that were previously supported under the JSI/DELIVER contract. This includes managing the LMIS system of parallel commodities. RPM Plus will maintain this database and help distribute reports to relevant divisions and agencies on stock status until it is ready to be transitioned to and maintained by KEMSA. When this transition happens, it will entail: expansion of the LMIS database to include all products warehoused and distributed by KEMSA, finalization of the LMIS user manual, training KEMSA and users from MOH departments (NASCOP, KEPI, RH, NLTP and essential drug programs) on how to use the LMIS and implementing facility based forms and tools for recording and summarizing commodity usage data. This component is part of the continued development of the national medical and pharmaceutical supply chain system that distributes ARVs and other medical and pharmaceutical commodities from the national warehouses to district warehouses and points of service.

Over 400 points of service - public, private, mission and NGO are served by this system. RPM Plus will work with key partners to update product selection according to MOH standard treatment guidelines, verify registration status, quantify requirements and update forecasts to enable uninterrupted procurement. The LMIS system will enable timely and accurate collection and reporting of ARV drug and other commodities to the National AIDS and STD Control Program (NASCOP), KEMSA, the Mission for Essential Drugs and Supplies (MEDS), divisions of the MOH, and other partners. Another new key component of the RPM Plus activities under COP 2007 is direct technical assistance to KEMSA to develop and implement their business plan, better manage warehouses and distribution schedules, and implement policy changes in procurement being done by the MOH in 2006. These integrated activities will be jointly funded with non-HIV/AIDS funds to support the entire national procurement and distribution system, with a key emphasis on reliable distribution of HIV/AIDS commodities down to the "last mile." Key partners with whom RPM plus will work include: KEMSA, the Kenya Government organization responsible for ensuring medical supplies to government facilities and currently responsible for distribution of all pharmaceuticals procured with resources from the Government of Kenya and the Global Fund, the Supply Chain Management System contract (SCMS), the major procurement and distribution partner of PEPFAR, the National AIDS and STD Control Program (NASCOP), the program with overall responsibility for management of the GOK program; the Mission for Essential Drugs (MEDS), a key distribution agent serving the NGO community with ARV drugs.

RPM Plus will also work with the Department of Pharmaceutical Services and its

institutions to support the policy and practice reform agenda aimed at strengthening national skills and capacity in commodity selection, quantification, procurement, distribution, quality assurance and appropriate use of commodities needed for the treatment and care of PLWHA. RPM Plus will also support activities by the pharmacy professional associations, the NGO/private sector aimed at improving access and use of ARVs and other medicines in support of the national ART programme. These will include implementation of the revised National Drug Policy to include components supportive of the provision of effective ART commodity management services; preparation of the national strategic plan to guide the pharmaceutical sub-sector; implementation of the Strategic Plan for Pharmaceuticals services, support to stakeholders in the development and dissemination of various ART policy guidelines; and advocacy for linkages between the Department of Pharmaceutical Services, NASCOP, PPB , KEMSA, NQCL in cross-cutting issues such pharmaco-vigilance, ART drug procurement and Quality Assurance.

At site level, RPM Plus will continue to provide technical assistance in the development and adaptation of SOPs and forms; use of inventory management tools for patient medication counseling for adherence; commodity management M&E systems, including Drug Utilization Reviews (DUR); the design and implementation of ART Drug Management Information Systems; and training and monitoring for performance improvement at site level employing the MTP methodology.

3. CONTRIBUTIONS TO OVERALL PROGRAM AREA These activities will support forecasting, procurement and tracking of supplies of antiretroviral drugs and other pharmaceuticals for at least 110,000 people. It will also help establish a sustainable national supply chain system capable of managing medical and pharmaceutical supplies in proportion to the national epidemic.

4. POPULATIONS TARGETTED The main populations targeted are people living with HIV/AIDS, health workers in both the public and private sector, and MOH policymakers and managers.

5. EMPHASIS AREAS The major emphasis area is commodity procurement. Minor emphasis areas are logistics, QA/QI/SS, Strategic Information, and Training.

1. LIST OF RELATED ACTIVITIES This activity is related to the HVTB activity (#8713).

2. ACTIVITY DESCRITION Management Sciences for Health (MSH) has worked in Kenya for the last 19 years and in other parts of Africa and the world for 34 years. MSH through its Rational Pharmaceutical Management (RPM) Plus program and other activities (e.g. Gates Funded SEAM Program), has worked at three Mombasa sites and elsewhere in Sub-Saharan Africa including Rwanda, Zambia, Namibia, Ethiopia and Uganda to improve laboratory management and quality of anti-retroviral therapy (ART) services. Under COP 2005, RPM Plus supported the National Public Health Laboratory Services (NPHLS) and the National AIDS and STD Control Programme (NASCOP) to develop a national laboratory policy and strategic plan. The NPHLS is the department of the Kenya Ministry of Health (MOH) charged with providing technical and tactical oversight for all laboratory services in Kenya.

As the lead Cooperative Agreement (CA) mandated by the Ministry of Heath NPHLS to guide laboratory system strengthening efforts through at the head of the Systems Interagency Coordinating Committee (ICC) sub-committee, RPM Plus will continue to apply lessons learnt in Mombasa to support sites' implementation of good laboratory practices as stipulated in the national laboratory policy. This will involve supporting NPHLS and NASCOP to improve existing laboratory management information systems (MIS); strengthen laboratory commodity management systems in support of ART; roll out implementation of Standard Operating Procedures (SOPs) for quality and efficiency of laboratory services; train providers in Good Laboratory Practices (GLP); strengthen management and coordination of the laboratory network; contribute to the development and implementation of a standardized in-service laboratory training curriculum; and implement internal and external quality assurance/control procedures.

RPM Plus will provide technical assistance to strengthen laboratory services in support of ART by working synergistically with the Laboratory ICC and other stakeholders. All RPM Plus laboratory activities will be conducted under the auspices of the NPHLS. This includes support for national-level activities such as those mentioned above as well as the implementation of the national laboratory policy; implementation of a national laboratory policy strategic plan; and development of institutional capacity by institutionalizing laboratory SOPs.

RPM Plus will also support NPHLS activities aimed at strengthening and scaling up laboratory activities at priority ART sites. Activities include: refurbishment of 10 priority laboratories (including the proposed Central Microbiology laboratory at the NPHLS), training laboratory staff in skills for ART, SOPs and good laboratory practices such as improved handling, transportation of specimens and return of results as well as universal precautions, and improved laboratory record keeping and MIS. In addition, this project will assist laboratories by providing guidance on the ART policy, professional and operational information and materials as needed; developing SOPs on equipment maintenance, and strengthening 10 sites to implement internal and external quality assurance procedures. The project will also provide support to laboratory supervisors to strengthen their management and coordination of laboratory services (supervisory check lists, job aids, monitoring tools, operational planning guides), and will help institutionalize laboratory quality assurance procedures including performance of internal quality controls (QCs) and calibration of equipment; training on the laboratory MIS, monitoring and evaluation (M&E) tools and the use of routine laboratory data. Additional activities include maintaining essential activities of the former JSI/DELIVER project, primarily maintaining an LMIS system to track warehousing and distribution of laboratory commodities in collaboration with the MOH and KEMSA. It will also include forecasting and quantification of laboratory procurement commodities as needed.

MSH/RPM Plus will closely collaborate with NASCOP, NPHLS, KEMRI, CDC, KEMSA, UON, AMREF, FHI KMTC, AKMLSO, KMLTTB, CDC, JSI, Clinton Foundation, USG HIV care and support grantees, private sector organizations and other stakeholders comprising the National Laboratory Inter-agency Coordinating Committee (ICC).

3. CONTRIBUTIONS TO OVERALL PROGRAM AREA This activity will result in improving access and use of quality diagnostic laboratory services

through improved laboratory policies and management, including use of SOPs and implementation of QA/QC systems. A total of 300 laboratory technologists will be trained in proper laboratory management, and labs in 10 ART sites will be refurbished and strengthened on requisite quality assurance procedures.

4. LINKS TO OTHER ACTIVITIES This activity links to the HVTB activity (#8713).

5. POPULATIONS TARGETED The populations targeted are laboratory technicians at priority Ministry of Health ART centers, and policymakers and division heads in the MOH.

6. EMPHASIS AREAS The main emphasis area is Training, with minor emphases on Strategic Information and QA/QI/SS.

na

Table 3.3.14: