A. Lending Instrument
The lending instrument used was a Specific Investment Loan (SIL). Financing of activities under the regional operation will take place through an IDA credit (Kenya, Tanzania, Uganda) or grant (Rwanda) to each participating country, depending on the financing terms that each country is eligible to receive from IDA.
B.Project Development Objective and Key Indicators
The development objective of the project is to establish a network of efficient, high quality, accessible public health laboratories for the diagnosis and surveillance of TB and other communicable diseases. To this end, the project will: (i) strengthen capacity to diagnose communicable diseases of public health importance and share information to mount an effective regional response (Component I); (ii) support joint training and capacity building to expand the pool of qualified laboratory technicians (Component II); and (iii) fund joint operational research and promote knowledge sharing to enhance the evidence base for these investments and support regional coordination and program management (Component III).
The proposed regional laboratory network aims to: (a) enhance access to diagnostic services for vulnerable groups to contain the spread of diseases in cross border areas; (b) improve capacity to provide specialized diagnostic services and conduct drug resistance monitoring at regional level; (c) contribute to disease surveillance and emergency preparedness efforts through the availability of timely lab data to provide early warning of public health events; and (d) serve as a platform for conducting training and research. The lab network will facilitate the adoption of harmonized policies, strategies, and protocols to ensure prompt and high quality results. Priority attention will be given to networking intermediate or satellite
laboratories that serve cross border and migrant populations, and central public health labs that provide specialized services.
Following broad based consultations, representatives from the participating countries have agreed to function as a community of practice for public health laboratory development, fostering cross country learning and knowledge sharing. The community of practice would become an integral part of the Africa Region‘s Health Systems for Outcome (HSO) initiative and contribute to knowledge sharing with other countries. Countries developed a common vision towards preventing and controlling the spread of communicable diseases in the Eastern Africa Region where heads of state recently signed an agreement to establish a common market which will lead to broader collaboration in all areas, including health. They acknowledged the importance of developing harmonized approaches, promoting specialization, and expanding information sharing about public health issues. The countries have agreed to provide regional leadership in key technical areas where each has a comparative advantage and would serve as a center of excellence, as follows:
Integrated Disease Surveillance and Response & Operational Research Building on its relatively strong IDSR system Kenya will serve as a center of excellence for disease surveillance and operational research. It will lead the development of harmonized tools; promote cross border surveillance and joint outbreak investigations; share lessons from the successful field epidemiology fellowship program and offer training programs to build regional surveillance capacities. Kenya will also lead a regional working group on operational research and work closely with ECSA-HC to develop standardized research protocols.
Lab Networking and Accreditation Uganda will provide leadership in establishing the East Africa public health regional lab network which will involve: (i) development of common standards; (ii) standardization of quality assurance systems; (iii) introduction of peer review mechanisms; and (iv) application of the WHO-AFRO Five-Step Accreditation process to accredit all laboratories in the proposed network to progressively meet the international certification with clearly defined parameters for turnaround time, quality, and proficiency, as described in Annex 3.
Training and Capacity Building Tanzania will provide high quality training in laboratory techniques at its new state of the art National Quality Assurance Laboratory and Training Centre and at the Muhimbili University of Health and Allied Sciences. Tanzania will use a phased approach: (i) initially offering short term courses; (ii) sharing training curricula and programs with other countries; (iii) providing Technical Assistance (TA) to other countries to develop continuing education programs; and (iv) developing e-learning approaches for distance learning.
Information and communication Technologies (ICT), Performance Based Financing (PBF), Multidrug Resistant Tuberculosis (MDR-TB) Rwanda has agreed to take a regional lead in expanding use of ICT and promoting PBF approaches for laboratory services, building on its well recognized successes in these areas. Cross cutting ICT innovations will be promoted to improve the quality of laboratory and surveillance data; facilitate the sharing of information; and promote e-learning and web- based knowledge sharing across countries. Rwanda will: (i) share its tools (e.g. standards and guidelines, reporting forms, request for proposals); (ii) provide related training,
capacity building, and technical support as well as organize site visits; and (iii) take a lead in determining the applicability of the PBF approach to public health laboratories and document and share lessons. Rwanda will also share lessons in MDR-TB as it has been selected by KNCV (Dutch TB Foundation) and will be supported by USAID to become a center of excellence for MDR-TB for the Africa region.
The proposed project focuses on four out of the five members of the EAC, which were ready to participate in the regional project. Burundi, the fifth member, has recently expressed interest to join the project, and will be considered for participation based on the initial implementation performance of the project and completion of the same preparation and appraisal requirements followed with the four other countries. To enhance readiness Burundi will be associated in knowledge sharing activities organized by the EAC and ECSA-HC.
To monitor results a core set of performance indicators has been agreed upon:
• Reduced average turn-around time for TB liquid culture tests (days).
• Satellite laboratories awarded two-star status under regional accreditation program based on WHO-AFRO five-step accreditation process (number, percent).
• Number of beneficiaries (direct and/or indirect; out of which x percent female).
• People receiving TB drug susceptibility tests among Directly Observed Treatment Short
Course (DOTS) treated TB cases not responding to treatment (number, percent).
• Share of reported communicable disease outbreaks having laboratory confirmation of etiological agent (percent).
• Outbreaks for which cross border investigations undertaken (number).
Component I: Regional Diagnostic and Surveillance Capacity (US$44.9 million)
The first component will provide targeted support to create and render functional the regional laboratory network. Uganda, working in close collaboration with ECSA-HC, will lead the establishment of the network. Component I includes three sub-components:
Diagnostic Services for Vulnerable Populations in Cross Border Areas (US$21.2 million) The first sub-component will support five satellite laboratories in each country and six in Tanzania to expand access to diagnostic services for vulnerable groups in cross border areas and to serve as sentinel surveillance sites to monitor hot spots for disease transmission. Bank financing will promote a systems approach to laboratory development and include: (i) support for rehabilitation, expansion, and/or construction of laboratories at existing hospitals; (ii) provision of laboratory equipment and materials, including waste management equipment and protective gear to ensure the safety of laboratory personnel; (iii) acquisition of computer equipment, software, and technical support for integrated laboratory information systems to improve the quality of data generated and videoconferencing capacity to allow personnel across sites to consult each other and to have access to timely information about disease outbreaks; and
(iv) provision of operating funds to render the laboratories functional, including strengthening human resources.
The satellite laboratories are based at regional or district hospitals in strategic cross border areas and/or in densely populated peri-urban areas where poverty is rampant and slum conditions serve as a breeding ground for the spread of diseases. Each country has carefully selected these sites based on the following criteria: (i) hospitals which are located in high transmission areas with large numbers of migrants or refugees; (ii) regional teaching hospitals which can serve as centers of excellence for conducting training and research; and (iii) commitment to collaborate and coordinate efforts within and across countries. The list of satellite laboratories is included in Annex 4. The satellites are essential to optimize surveillance efforts and contain the spread of communicable diseases in the region.
Countries will adopt a phased approach with a results focus based on standardized quality practices. In an initial phase, human resources would be bolstered, training would be conducted, and proficiency testing would be carried out to ensure that basic microscopy and other core lab functions are performed according to set standards. During a second phase, specialized diagnostic services would be introduced once the physical infrastructure has been upgraded. Underpinning the phased approach will be the accreditation of all satellite laboratories using the WHO/AFRO five-step accreditation process, with the goal of reaching a two-star status by project completion. Accreditation instills continuous learning, affords confidence in lab results by clinicians and patients, and provides evidence of quality.
Reference and Specialized Services and Drug Resistance Monitoring (US$22.5 million) The project will bolster the capacities of the Central Public Health Laboratories in the participating countries and network them to share information, conduct joint training and research, and collaborate in harmonizing policies and strategies. This process will focus on the TB laboratory functions (which have been relatively neglected), supporting one of the labs to be upgraded to a Supranational Regional Laboratory (SRL). The project will finance: (i) rehabilitation/construction and lab equipment and materials for central public health laboratories, including TB reference laboratories; (ii) acquisition of computers and videoconferencing capacity to facilitate sharing of information and link into existing telemedicine installations where appropriate; (iii) TA to support accreditation of satellite labs and standardization of procedures and protocols to ensure that diagnostic procedures are performed by appropriately trained technicians against clear regional and international proficiency and quality standards; and (v) provision of operating funds to support inter-laboratory external quality assessments among the four participating countries and recruitment of additional personnel to provide mentorship to personnel at satellite laboratories.
As national capacities are enhanced and the network becomes fully functional, one of the four labs would play the role of a regional laboratory for East Africa, providing services (e.g. quality control; support with drug resistance surveys; higher-level testing, including second line drug susceptibility testing and molecular diagnostics) to other laboratories in neighboring countries, thus reducing the need to ship specimens to laboratories on other continents. The process of accreditation is being led by the WHO and other technical partners. Once a decision is taken on which laboratory will play the SRL role, the project will be used to develop the financial arrangements and operational modalities for the regional lab to provide services and for other countries to acquire those services.
Disease Surveillance and Preparedness (US$1.3 million)The proposed project will complement ongoing regional and global initiatives to improve Integrated Disease Surveillance and Response (IDSR) country systems. It will support the IDSR strategic goals to improve availability of quality information by: (i) strengthening competence of lab and facility personnel to collect, analyze, and use surveillance data; (ii) reinforcing lab networking and district capacity (particularly those in border areas) to report, investigate, and adequately respond to disease outbreaks; and (ii) strengthening communications and data sharing to respond rapidly to outbreaks. Kenya will take a lead in this area and work closely with the EAC health desk to harmonize tools, offer training and technical support, and serve as a center of excellence, documenting and sharing good practices in disease surveillance.
The strategy is to start gradually and prioritize a few diseases for Bank support, including those which are: (a) outbreak prone (cholera, meningitis, hemorrhagic fever), (b) endemic (multi-drug resistant TB), or have (c) pandemic potential (influenza). The project will also provide complementary support to the EAC for the East Africa Integrated Disease Surveillance Network to enhance its effectiveness, and facilitate the production of quarterly regional surveillance bulletins.
Bank funding will assist the countries to comply with their commitments under the International Health Regulations. To this end, the project will support laboratory-based disease surveillance efforts by: (i) strengthening etiological confirmation of pathogens and promoting active participation of laboratory and other health personnel in disease surveillance and disease outbreak investigations; (ii) establishing and maintaining an integrated data management system; and (iii) facilitating sharing of relevant data across the sub-region, including publication of periodic newsletters and quarterly and annual disease surveillance reports. These activities will be funded through the provision of TA, operating costs, ICT services and training.
Component II: Joint Training and Capacity Building (US$9.9 million)
The project will support training in a range of institutions in the four countries and across the region. Tanzania will provide leadership in this area and establish a regional training hub. It will provide practical training at its state of the art National Health Laboratory Quality Assurance and Training Centre and in-service training and post-graduate mentorships at the Muhimbili University of Health and Allied Sciences. Other regional training programs (such as the International Tuberculosis course on TB control organized by the International Union Against Tuberculosis and Lung Disease, The Union, in collaboration with the Tanzanian National Tuberculosis/Leprosy Program) and other training centers like the African Center for Integrated Laboratory Training in Johannesburg will be supported, particularly for training of trainers.
Each country has prepared and finalized a training plan which provides details of short and long term programs, including regional and longer term training in identified areas of laboratory sciences and field epidemiology. It was agreed that the scope of all critical training programs supported under the project such as laboratory management, infection control and bio-safety, and disease outbreak investigation would be nation-wide, ensuring synergies with activities provided by other partners, while training programs linked to specific inputs provided under the project, such as rapid TB diagnosis and cultures, will be limited to staff working at the laboratories supported by the project. In addition, a three-month certificate program with credits on leadership will be developed and introduced for laboratory managers to enhance career prospects. Trainees will include staff from private laboratories. The project will support fellowships in field epidemiology through the flagship Field Epidemiology and Laboratory Training Program (FELTP). By project completion over 2000 laboratory specialists will have received training and a professional cadre of laboratory managers will be established in the sub- region.
The Bank project will finance: (i) attendance at training courses at national and regional institutes; (ii) laboratory attachments, fellowships, and regional exchanges at recognized centers of laboratory excellence; (iii) selective graduate training required to support specialized services; (iv) TA to review and develop standards and training curricula; and (v) regional workshops to facilitate knowledge sharing.
Component III: Joint Operational Research, Knowledge Sharing/Regional Coordination, and
Program Management (US$8.7 million)
Joint Operational Research The project will finance relevant operational research which is related to activities supported under the project. The three main research priorities identified by countries relate to the need to: (i) evaluate the effectiveness of the new TB related diagnostic technologies at the programmatic level, (ii) assess drug resistance patterns for endemic diseases, and (iii) ascertain the feasibility of using mobile phone technologies for weekly surveillance reporting of selected priority diseases. The evidence generated through this joint operational research will help inform public policy and the scale up of these interventions in the participating countries and in the region. As agreed during project preparation, Kenya would set up an operational research working group, and work closely with ECSA-HC. The project will fund: (a) TA to support operational research; (b) operating costs to organize workshops to share results; and (c) training to boost capacities to conduct research.
Knowledge Sharing & Regional Coordination ECSA-HC will play a coordinating and convening role and be responsible for the following activities at the regional level:
•Convene Technical Experts and Policymakers: The organization will support the country-led working groups by providing a forum for discussions and deliberations. The ECSA-HC Secretariat will facilitate the work of technical partners which will assist in harmonizing laboratory operating procedures and quality assurance systems. ECSA-HC will use its existing mechanisms (e.g. conference of health ministers; advisory committee of permanent secretaries) to share results from the regional project, and advocate for policy change at both the technical and policy levels.
•Facilitate Capacity Building and Training: The ECSA-HC will support countries to implement regional studies on human resources (HR) for laboratory services and public/private partnerships7 with a view to identifying options for enhancing the quality
As discussed in Annex 4, the PPP assessment will document innovative approaches and suggest options for expanding these arrangements, including operating specialized lab services in public hospitals, and providing maintenance services.
and efficiency of laboratory services; prepare policy briefs on HR and PPP issues; take stock of training institutions offering higher level training; and facilitate networking of laboratory managers by organizing bi-annual professional meetings.
• Establish a Forum for Learning and Knowledge Sharing: The organization will facilitate exchanges of experiences; document best practices in laboratory networking in the region; work with their health journalist network to report on achievements and lessons; establish a peer review mechanism for reviewing research findings; and drawing policy conclusions to be brought to the attention of policy makers; maintain a repository of information on activities supported under the project which can be shared regionally; and prepare a regional communications strategy for disseminating main lessons from the project, and informing the public on related public health issues.
• Facilitate Regional Surveillance Efforts: The ECSA-HC Secretariat will support the EAC to: implement the strategic plan for developing the East Africa Integrated Surveillance Network as a model regional network and producing quarterly surveillance bulletins; work with country surveillance focal points and technical partners to develop standardized reporting tools and protocols for sharing information on selected communicable diseases (e.g., Cholera, Meningitis, MDR TB, Influenza, Polio) in the region; and facilitate cross border outbreak investigations when satellite laboratories report disease outbreaks.
The project will fund: (i) operating costs to organize regional workshops to share research and programmatic results, and explore policy implications; (ii) establishment of a small team to coordinate activities at the regional level and a focal point at the EAC; (iii) videoconferencing capacity; (iv) development of a website to serve as a platform for sharing of information and results of research; and (v) TA.
Program Management At the national level the project will support program management through the provision of funds for the establishment of project coordinating teams, operating costs, and procurement of office equipment, vehicles, and internet access.
D. Lessons Learned and Reflected in the Project Design
It is well recognized that regional projects are inherently more challenging to design and implement but have the potential to generate results which are not easily attained through national investments. Drawing on the recent review of regional projects by the Quality Assurance Group, the 2009 IDA 15 Mid-Term Review of the IDA Regional Program, and the
2007 Independent Evaluation Group (IEG) review of regional programs, the following key lessons have been incorporated into the design:
• Conduct analytical work Project design has been informed by analytical work conducted during project preparation, including a study on the importance of laboratories (A Weak Link to Improving Health Outcomes in Low-Income Countries: Laboratories); and country specific assessments conducted by the US Center for Disease Control and Prevention which documented gaps, and proposed the rationale for the proposed activities, as noted in Annex 1.
• Ensure ownership Project preparation has benefited from high-level support from ministers, and permanent secretaries who have welcomed this initiative and provided strong leadership; program managers, partners, and civil society groups who have contributed actively to the preparation process. The project builds on long standing cooperation on health issues within the East African Community (EAC), and ongoing collaboration between ECSA-HC, EAC, and participating countries.
• Promote partnerships The preparation of the operation was conducted in close collaboration with key partners involved in lab strengthening and TB control to take advantage of global expertise and country knowledge and to identify opportunities for complementary support.
• Adopt coordinated approaches As seen during the eradication of smallpox, in progress towards elimination of Onchocerciasis, and in control of meningitis, a high level of regional collaboration and collective action is critical to successful public health initiatives. For example, it is widely recognized that stepped up regional surveillance efforts, cross border collaboration, information sharing among laboratories, and regional stockpiling of vaccines have been critical in equipping countries to better cope with frequent meningitis outbreaks.
• Ensure design simplicity The project has three components. It will rely and strengthen existing implementation structures and not create new ones.
• Leverage national institutions Drawing on lessons from successful regional operations, the project promotes the concept of ―design regionally—implement nationally‖ by relying on national institutions for execution and implementation of project interventions at the
country level, and on regional institutions for supportive services that cannot be performed efficiently by national agencies, such as coordination.
• Develop a strong Monitoring and Evaluation framework The project design has a strong focus on M&E which is critical to enhancing the evidence base for rolling out new technologies and approaches. Drawing on lessons from regional projects, the main research topics were agreed up front and a Regional Advisory Panel will be established to facilitate multi-country learning.
• Plan for sustainability The team adopted a health systems approach which focuses attention on how this regional program will add value to service delivery at the country level, what will be required to sustain activities and country commitment, and how the Bank‘s annual sector and budget reviews can be used to foster support. Countries will monitor and report on the availability of resources for laboratories supported under the project and ensure that personnel recruited under the project are absorbed into the civil service or funded by other partners.
E. Alternatives Considered and Reasons for Rejection
A first option considered was to integrate the regional program activities into relevant projects which are on-going or under preparation. While this option was appealing in terms of limiting the number of operations the nature of the proposed activities called for the establishment of a strong regional platform for harmonizing strategies and promoting learning and knowledge sharing. Second, a disease specific program focused only on TB lab strengthening was considered and rejected. While TB lab strengthening will be supported, the project has adopted a systems approach which will involve: (i) introduction of standardized systems (e.g. quality assurance, information and communication) that will have broader benefits; (ii) promotion of an integrated model for providing diagnostic services in border areas that cuts across diseases; and (iii) laboratory based disease surveillance which will focus on diseases which are epidemic prone, endemic, or have pandemic potential.