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      Clinical Laboratory Networks Contribute to Strengthening Disease Surveillance: The RESAOLAB Project in West Africa

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          Abstract

          Sufficient laboratory capacity is essential to effective infectious disease surveillance and control. This is recognized in the current International Health Regulations (IHR), which identify laboratory services as a category of core capacities that all the World Health Organization (WHO) Member States are expected to develop and maintain (1). IHR Core Capacity 8 requires laboratory services for every phase of real-time event management (i.e., detection, investigation, and response), with sample analysis being performed either domestically or through collaboration centers (2). Laboratory services are considered a key component of national health systems, with the Integrated Disease Surveillance and Response (IDSR) utilizing the structures, processes and personnel of national clinical laboratory services for disease surveillance. However, laboratory services for both patient care and disease surveillance remain among the most neglected components of the overall health system in resource-poor countries. Challenges include lack of national laboratory policy and strategic planning, insufficient numbers of trained professionals, poor laboratory infrastructures, and absence of quality management systems (3). Thus, several calls have been put forth to improve laboratory capacity in resource-poor countries. In 2008, representatives of African governments, local and international partners participated in a consensus meeting on clinical laboratory in Maputo, Mozambique. Meeting participants called on national governments to develop national laboratory policies and to provide laboratory support for diseases of public health importance; and they called on donors and development partners to commit to work collaboratively with each other and with coordination from national governments to strengthen laboratory systems (4). The WHO Regional Office for Africa (WHO/AFRO) has also advocated strengthening national public health laboratories (5). Also in 2008, WHO and the US Centers for Disease Control and Prevention (CDC), Atlanta, USA, convened in Lyon, France, an international conference on laboratory quality systems. During that meeting, the need for accurate laboratory testing was stressed, with poor quality laboratory services in resource-constrained countries leading to untold misery in human lives and unnecessary expenditures due to inadequate treatment (6). Eight key interventions were identified: (i) strengthening laboratory management at all levels; (ii) strengthening infrastructure and support systems; (iii) developing human capacity; (iv) establishing a national laboratory referral network; (v) establishing a national quality assurance program; (vi) developing a comprehensive monitoring system including laboratory information management system; (vii) coordinating government and partner support activities; and (vii) mobilizing resources to finance the strategic plan. The need to integrate networks that already exist – mostly those related to malaria, tuberculosis and HIV/AIDS – was also stressed. In response to these calls, several international development partners have been implementing capacity building programs that include the training of laboratory personnel in epidemiology (7), microbiology (8) and quality assurance (9). In 2005, Fondation Mérieux, with the support of the European Commission, launched a national laboratory network initiative in Mali called Action BIOMALI. In just four years, the network grew to cover more than eighty public and private laboratories. In 2009, in response to official demands from the Ministries of Health of two neighboring countries, Burkina Faso and Senegal, and with the support of the French Development Agency (AFD) and Fondation Mérieux, the Mali network was expanded into a three-country regional network called RESAOLAB. This article describes the major activities and accomplishments of RESAOLAB and presents RESAOLAB as an example of how disease surveillance capacity can be built using a regional network strategy. Established in 1967, Fondation Mérieux is an independent family foundation. Recognized as a state-approved charity in Lyon, France, the Foundation works to reduce the impact of infectious diseases that affect developing countries and currently operates in four countries. Fondation Mérieux prioritizes partnerships and catalyzes both local and international initiatives aimed at helping researchers and health care workers in developing countries learn how to use the best available scientific and medical tools so that they can meet their countries’ public health needs in the long term and independently. Based on its long history of expertise in clinical biology and a comprehensive approach to public health, the Foundation's work serves as a model for strengthening local laboratory capacities. RESAOLAB RESAOLAB strengthens the quality of clinical laboratory services through inter-country meetings and workshops that promote the exchange of knowledge and experiences and harmonization of documents and tools. The network focuses on three main areas of activity: training laboratory personnel, setting quality assurance, and strengthening epidemiological surveillance. Training laboratory personnel The three network countries jointly developed a shared national strategic plan for continuous education of laboratory technicians; all three Ministries of Health officially validated the plan. The countries also jointly wrote content for the continuous education program, which includes a total of nine training modules. In each country, four reference structures were set up to organize training sessions, with a focus on use of harmonized equipment. To date, a total of 64 training sessions have been conducted, with 25 participants per session. The training modules are available for self-training through the GLOBE portal (10). Setting quality assurance As with the laboratory technician training, the three network countries jointly developed a shared national plan for laboratory quality management, which was then validated and adopted by all three Ministries of Health. The document defines standards for personnel organization, laboratory equipment, procedures, data processing, and hygiene and security. Additionally, the network identified and equipped four laboratories in each country responsible for maintaining external quality control. To date, the network has conducted more than 350 supervised external quality control assessments to evaluate the quality of diagnostics being used and identify necessary corrective measures. Strengthening the epidemiological surveillance system Improving the management and the quality of laboratory data has a direct impact on the epidemiological surveillance system. RESAOLAB developed an open-source Laboratory Information and Management System (Lab-Book) for monitoring all daily surveillance activities (from requests for analysis to reporting). Based on jointly defined reference terms, Lab-Book contains an epidemiological application for reporting laboratory data; in collaboration with WHO/AFRO, RESAOLAB conducted a regional workshop to discuss use of the new tool, including the role of the laboratory in reporting epidemiological data to surveillance databases. Fifteen laboratories in each country are expected to participate in a pilot launch of Lab-Book. The network also proposed computer and other equipment, Internet services, and training that will be necessary for integrating Lab-Book across the region. Key achievements In addition to the activities described above, three other key achievements are worth noting here. First, after many meetings advocating for laboratory governance and following Burkina's lead, Senegal established a national laboratory department under the Ministry of Health. Second, during a cholera outbreak in Mali in July 2011, RESAOLAB laboratory technicians played a critical role in the collection and preliminary analysis of surveillance data by directly applied procedures they had learned in the “Epidemic-Prone Diseases in the Laboratory” training module. The outbreak affected nine health districts in Mopti and Timuktu. It started on July 5. By August 4,463 cases had been reported, with a case fatality rate of 5.18 percent (24 deaths). Finally, recognizing the value of regional laboratory networking, four other countries in the region – Benin, Guinea, Togo, and Niger – have made requests to their Ministries of Health to join RESAOLAB. Conclusion RESAOLAB grew from national and regional dialogue around the need for harmonized tools and processes. It serves as a model for groups of neighboring countries that would like to strengthen the laboratory component of their disease surveillance infrastructure by jointly developing and implementing trainings and other activities and by harmonizing and linking national databases into integrated regional systems. As described elsewhere in this special issue of Emerging Health Threats, other regions, like South East Europe, are taking similar steps to strengthening disease surveillance laboratory capacity (11).

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          Laboratory Systems and Services Are Critical in Global Health

          Abstract The $63 billion comprehensive global health initiative (GHI) emphasizes health systems strengthening (HSS) to tackle challenges, including child and maternal health, HIV/AIDS, family planning, and neglected tropical diseases. GHI and other initiatives are critical to fighting emerging and reemerging diseases in resource-poor countries. HSS is also an increasing focus of the $49 billion program of the US President’s Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria. Laboratory systems and services are often neglected in resource-poor settings, but the funding offers an opportunity to end the neglect. To sustainably strengthen national laboratory systems in resource-poor countries, the following approaches are needed: (1) developing integrative national laboratory strategic plans and policies and building systems to address multiple diseases; (2) establishing public-private partnerships; (3) ensuring effective leadership, commitment, and coordination by host governments of efforts of donors and partners; (4) establishing and/or strengthening centers of excellence and field epidemiology and laboratory training programs to meet short- and medium-term training and retention goals; and (5) establishing affordable, scalable, and effective laboratory accreditation schemes to ensure quality of laboratory tests and bridge the gap between clinicians and laboratory experts on the use of test results.
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            International Health Regulations (2005)

            On May 23, 2005, the 58th World Health Assembly, consisting of the 192 Member States of WHO, adopted the revised International Health Regulations (IHR), the code of international regulations for the control of transboundary infectious diseases. 1 The spread of severe acute respiratory syndrome illustrated the rapidity with which a new infectious disease can spread and affect today's interconnected world. The deliberate release of anthrax in the aftermath of the events of Sept 11, 2001, highlighted another dimension of microbial threats. Neither event was adequately addressed in the previous IHR of 1969. 2 The key constraints of IHR (1969) were the limited scope of diseases (cholera, plague, yellow fever), the dependence on official notification to WHO by affected countries, the scarcity of mechanisms for collaboration in investigating such outbreaks, and the lack of specific risk-reduction measures to prevent the international spread of disease. Indeed, there was disincentive to reporting under the IHR because unaffected countries applied travel and trade restrictions far in excess of the true risks of the disease. The new IHR 2005 goes some way toward addressing these issues by establishing expert panels to review the risks to international public health and recommend evidence-based control measures. However, even the revised IHR show an inevitable compromise between national sovereignty and the collective international good; of trying to ensure the maximum security against the international spread of disease with minimum interference to travel and trade. New infectious diseases have been emerging at the unprecedented rate of about one a year for the past two decades, a trend that is expected to continue.3, 4 In the past 10 years, new and emerging infectious diseases with a potential threat to international public health include Ebola, Lassa, and Marburg haemorrhagic fevers in Africa, variant Creutzfeldt-Jakob disease in Europe, meningococcal meningitis W135 associated with returning Hajj pilgrims, Nipah virus in Malaysia, West Nile virus in the Americas, severe acute respiratory syndrome, and the pandemic threat from avian influenza H5N1 in Asia. There is clearly a need for new approaches to confront these emerging threats from infectious disease. In 2000, the WHO Department of Communicable Diseases Surveillance and Response in Geneva initiated the formation of the Global Outbreak Alert and Response Network (GOARN), 5 which provides the operational and technical response arm for control of global outbreaks. In 2000–04, GOARN responded to 34 events in 26 countries, and has grown to a partnership of over 120 institutions and networks, including UN and intergovernmental organisations. The Network provided substantial support to affected countries during the outbreak of the severe acute respiratory syndrome and in response to avian influenza. It was clear that the IHR (1969) also needed to change to allow response to contemporary threats to international health. Efforts towards achieving this response began in 1995. 6 The purpose and scope of the IHR (2005) are to prevent, protect against, control, and provide a public-health response to the international spread of disease in ways that are commensurate with and restricted to public-health risks, while avoiding unnecessary interference with international traffic and trade. The IHR (2005) affirm the continuing importance of WHO's role in global outbreak alert and response to public-health events. The revised IHR spell out the responsibilities for WHO, other international agencies with a mandate to protect public health (including radiation health and chemical safety), and the Member States themselves. A decision instrument has been developed to assist countries in determining whether an unexpected or unusual public-health event within its territory, irrespective of origin or source, might constitute a public-health emergency of international concern and require notification to WHO. Criteria include morbidity, mortality, whether the event is unusual or unexpected, its potential to have a major public-health effect, whether external assistance is needed to detect, investigate, respond, and control the current event, if there is a potential for international spread, or if there is a significant risk to international travel or trade. The IHR (2005) explicitly recognise the need for intersectoral and multidisciplinary cooperation in managing risks of potential international public-health importance. Key partners include intergovernmental organisations or international bodies with which WHO is expected to cooperate and coordinate its activities: eg, the UN, International Labour Organization, Food and Agriculture Organization, International Atomic Energy Agency, International Civil Aviation Organization, International Committees and Federations of the Red Cross and Red Crescent Societies, and Office International des Epizooties. The revised IHR set out core capacities of a country's preparedness to detect and respond to health threats—early warning and routine surveillance systems, epidemiological and outbreak investigation skills, laboratory expertise, information and communication technologies, and management systems. WHO will continue its traditional role of providing support for national capacity building to achieve these core capacities. A short list of diseases (figure ) needing mandatory notification to WHO are included in the decision instrument; however, countries are now also required to assess the international public-health threat posed by any unusual health event, including those of unknown causes or sources, and outbreaks caused by agents with the known ability to cause serious public-health effect and to spread rapidly internationally. Importantly, WHO can now use a range of sources of health intelligence to raise an alarm and begin a process of verification with countries that have not voluntarily reported significant health events. Parties capitalised to the IHR are required to inform WHO within 24 h of the receipt of evidence of a public-health risk that might cause international spread of a disease. Finally, if WHO obtains credible evidence that a public-health event of international importance has occurred and fails to obtain disclosure and cooperation by the affected state, it has discretionary power to release the public-health information required to protect global public health. Figure Simplified decision instrument for assessment and notification of events that might constitute public-health emergency of international concern under International Health Regulations (2005) The IHR work on the principle of global public good—protecting public health through early detection and response to public-health emergencies benefits the nation concerned and reduces the risks of spread to other nations. 7 Their impact will be limited unless national governments accept their global public-health responsibilities. Furthermore, because most human emerging infectious diseases are zoonotic in origin, there is a need for close collaboration between the veterinary, human health, and wildlife sectors. 8 The regulations of the Office International des Epizooties, the veterinary counterpart of the IHR, face similar challenges as did the IHR (1969), and perhaps need a similar overhaul. The problems currently faced in confronting the threat to human and animal health posed by the outbreaks of avian influenza A H5N1 in Asia amply illustrate this contention. The IHR (2005) will enter into force in 2007.
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              A shifting paradigm in strengthening laboratory health systems for global health: acting now, acting collectively, but acting differently.

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                Author and article information

                Journal
                Emerg Health Threats J
                Emerg Health Threats J
                EHTJ
                Emerging Health Threats Journal
                Co-Action Publishing
                2001-1350
                1752-8550
                25 January 2013
                2013
                : 6
                : 10.3402/ehtj.v6i0.19960
                Affiliations
                [1 ]Fondation Mérieux, France
                [2 ]Ministry of Health, Mali
                [3 ]Ministry of Health, Burkina Faso
                [4 ]Ministry of Health, Senegal
                [5 ]Agence Française de Développement, France
                Author notes
                [* ] Josette Najjar-Pellet, Email: josette.najjar@ 123456fondation-merieux.org
                Article
                19960
                10.3402/ehtj.v6i0.19960
                3557952
                23362415
                3e597615-d860-4ffe-b8ee-12d9f57cd6d2
                © 2013 Josette Najjar-Pellet et al.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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                Public health
                Public health

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