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Universal access to malaria diagnostic testing; an operational manual
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    Foreword -- Abbreviations -- Acknowledgments -- Glossary -- Preamble. -- Introduction. -- 1. Programme Planning and Management. -- 1.1 Terms of reference for the national coordination group on malaria diagnosis. -- 1.2 Situation analysis and gap identification. -- 1.3 Roles and responsibilities. -- 2. Policies and Technical Guidelines. -- 2.1 Update relevant national policies -- 2.2 Address regulatory issues -- 2.3 Prepare national guidelines. -- 2.4 Prepare an implementation plan -- 3. Procurement and Logistics of Malaria Tests. -- 3.1 Selection of products for malaria diagnosis . -- 3.2 Quantification and forecasting of requirements for malaria testing. -- 3.3 Procurement of supplies for malaria testing. -- 3.4 Distribution, transport and storage -- 3.5 Stock management -- 3.6 Maintenance of microscopes and other equipment. -- 4. Components of the Quality Management System -- 4.1 Overview of quality management at different levels -- 4.2 Quality management activities at central level. -- 4.3 Quality management activities at subnational level -- 4.4 Quality assessment at points of care -- 4.5 Action to be taken in cases of nonconformity with malaria testing. -- 4.6 Country scenarios. -- 5. Training of Health Workers and Supervisors -- 5.1 Sensitization. -- 5.2 Organization of in-house training at all levels. -- 5.3 Integration into pre-service training. -- 5.4 Training in integrated management of fever -- 6. Supervision at Points of Care (Health Facilities and the Community) -- 7. Information, Education and Communication -- 7.1 Preparing a communication plan -- 7.2 Roles and responsibilities. -- 8. Monitoring and Evaluating Tte Programme -- 8.1 Establishing indicators and monitoring -- 8.2 Trouble-shooting, investigation and response -- 9. Expected Impact on Malaria Surveillance -- 10. Diagnostic Strategies in Particular Settings -- 10.1 Advanced malaria control and pre-elimination. -- 10.2 Areas in which malaria has been eliminated -- 10.3 Non-endemic areas. -- 10.4 Endemic-prone areas -- 10.5 Complex emergencies. -- Resource documents -- Annex 1. Standard operating procedures for the use, care and maintenance of microscopes -- Annex 2. Specification sheet for laboratory equipment. -- Annex 3. Maintenance service report for laboratory equipment. -- Annex 4. Register for maintenance of laboratory equipment -- Annex 5. Standard operating procedures for storage of rapid diagnostic tests at points of care. -- Annex 6. Standard operating procedures for management of wastes from malaria diagnostic tests -- Annex 7. Testing for proficiency in reading blood slides against reference slides -- Annex 8. Checklist for supervision of laboratories performing malaria testing -- Annex 9. Checklist for direct observation of laboratory technicians performing malaria microscopy -- Annex 10. Checklist for direct observation of health workers performing rapid diagnostic tests for malaria -- Annex 11. Case scenarios for training in use of rapid diagnostic tests in clinical management -- Annex 12. Checklist for supervision of malaria diagnostic testing in health facilities -- Annex 13. Checklist for supervision of clinical management of febrile children at health facility level.

    The aim of this interagency manual is to provide policy, strategy, technical and operational guidance to countries wishing to strengthen or set up routine malaria diagnostic services. These services include the use of both microscopy and rapid diagnostic tests (RDTs) at all levels for the management of febrile patients by health workers and are integrated within other national programmes for strengthening laboratory services. This operational guide is primarily for national, provincial and district health and laboratory managers in ministries of health and malaria control programme and for the managers of other health agencies, nongovernmental organizations and faith-based organizations working with national health authorities to strengthen malaria diagnostic services. The manual starts with a section on programme aspects (section 1), followed by descriptions of the policies and guidelines that are needed in a programme to strengthen malaria diagnostic testing (section 2). The various activities are then described (sections 3-7), with the different aspects of monitoring and surveillance (sections 8 and 9). Strategies for particular settings are briefly proposed in section 10. Although the general approach is directed to programme management, some sections and tools might be useful for designing training materials and standard operating procedures for health professionals (doctors, nurses and health officers) and laboratory staff (scientists, technicians and microscopists) working in programmes for the diagnosis and treatment of patients with malaria. Most of the tools are described in the annexes to this manual. This manual is a synthesis of important issues published previously, presented in an accessible format, and is intended to give a practical approach to establishing a reliable system for malaria diagnostic testing. References to WHO publications available online, which provide more detailed information, are listed throughout this manual and in the annexes. The manual is intended to provide general guidance, which may help countries to prepare or revise their operational manuals by involving national health authorities and technical partners active in this area of work. For example, the manual makes reference to health facility support to community health workers in conducting malaria diagnostic testing at community level. These sections might not be relevant to all countries. The aim of the manual is to stimulate the development of malaria diagnostic testing and management, not as a vertical programme but integrated with activities at various levels of the health system. A key condition for its success is that malaria diagnostic testing not be practised on its own but as one component of the management of febrile patients, including causes of fever other than malaria. Experience in several countries (Burkina Faso, Ghana, Nigeria, Papua New Guinea, Uganda, the United Republic of Tanzania (including Zanzibar) and Zambia) has shown that, with good training and support, health workers adhere to the results of malaria tests and treat only positive patients. This manual provides technical guidance on who should be tested for malaria and how. This is a major shift from other criteria for deciding who should be treated for malaria. It aligns the management of malaria with that of any other disease for which a reliable diagnostic test is universal access to malaria diagnostic testing: An operational manual available. When the terms 'RDT' and 'microscopy' are used in a recommendation, it is considered as implicit that the tests are quality assured and therefore that they provide reliable, reproducible results in line with their technical characteristics. When not explicitly mentioned, the statements in the manual apply to all Plasmodium species (falciparum and non-falciparum). This manual is intended to be read comprehensively, although some sections and tools given in the annexes can stand alone.

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