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Universal Access to Malaria Diagnostic Testing an Operational Manual Access Global Malaria Programme World Health Organization 20 Avenue Appia

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Universal Access to Malaria Diagnostic Testing an Operational Manual Access Global Malaria Programme World Health Organization 20 Avenue Appia UNIVERSAL ACCESS TO MALARIA DIAGNOSTIC MANUAL TESTING OPERATIONAL N A | AN OPERATIONAL MANUAL TESTING DIAGNOSTIC MALARIA TO Universal Access to Malaria Diagnostic Testing An Operational Manual ACCESS Global Malaria Programme World Health Organization 20 avenue Appia ISBN 978-92-4-150209-2 UNIVERSAL 1211 Geneva 27 Switzerland http://www.who.int/malaria/en/ Universal access to malaria diagnostic testing AN OPERATIONAL MANUAL i WHO Library Cataloguing-in-Publication Data: Universal access to malaria diagnostic testing: an operational manual. 1.Malaria – diagnosis. 2.Antimalarials – therapeutic use. 3.Malaria – drug therapy. 4.Diagnostic tests, Routine – utilization. 5.Manuals. I.World Health Organization. ISBN 978 92 4 150209 2 (NLM classification: WC 750) © World Health Organization 2011 All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site (http://www.who.int/ about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publica- tion. However, the published material is being distributed without warranty of any kind, either expressed or implied. The respon- sibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Designed by minimum graphics Printed in Malta Contents Foreword ................................................................................................................................... vii Abbreviations .............................................................................................................................ix Acknowledgments .......................................................................................................................x Glossary .................................................................................................................................... xii Preamble ......................................................................................................................................1 Introduction ................................................................................................................................3 1. Programme planning and management ............................................................................7 1.1 Terms of reference for the national coordination group on malaria diagnosis ..............7 1.2 Situation analysis and gap identification ..............................................................................8 1.3 Roles and responsibilities ........................................................................................................9 2. Policies and technical guidelines ......................................................................................16 2.1 Update relevant national policies.........................................................................................16 2.2 Address regulatory issues .....................................................................................................17 2.3 Prepare national guidelines ..................................................................................................18 2.4 Prepare an implementation plan .........................................................................................30 3. Procurement and logistics of malaria tests ......................................................................39 3.1 Selection of products for malaria diagnosis ......................................................................39 3.2 Quantification and forecasting of requirements for malaria testing ..............................41 3.3 Procurement of supplies for malaria testing ......................................................................45 3.4 Distribution, transport and storage .....................................................................................46 3.5 Stock management .................................................................................................................47 3.6 Maintenance of microscopes and other equipment ..........................................................47 4. Components of the quality management system .............................................................49 4.1 Overview of quality management at different levels .........................................................49 4.2 Quality management activities at central level ..................................................................49 4.3 Quality management activities at subnational level .........................................................56 4.4 Quality assessment at points of care ...................................................................................57 4.5 Action to be taken in cases of nonconformity with malaria testing ..............................63 4.6 Country scenarios ..................................................................................................................67 5. Training of health workers and supervisors ....................................................................70 5.1 Sensitization ............................................................................................................................70 5.2 Organization of in-house training at all levels ..................................................................70 5.3 Integration into pre-service training ..................................................................................77 5.4 Training in integrated management of fever .....................................................................78 6. Supervision at points of care (health facilities and the community) ..............................80 CONTENTS iii 7. Information, education and communication ...................................................................83 7.1 Preparing a communication plan ........................................................................................83 7.2 Roles and responsibilities ......................................................................................................83 8. Monitoring and evaluating the programme ....................................................................85 8.1 Establishing indicators and monitoring .............................................................................85 8.2 Trouble-shooting, investigation and response ...................................................................89 9. Expected impact on malaria surveillance ........................................................................94 10. Diagnostic strategies in particular settings .....................................................................96 10.1 Advanced malaria control and pre-elimination ................................................................96 10.2 Areas in which malaria has been eliminated .....................................................................96 10.3 Non-endemic areas ................................................................................................................97 10.4 Endemic-prone areas .............................................................................................................97 10.5 Complex emergencies ............................................................................................................97 Resource documents .................................................................................................................98 Annexes ...................................................................................................................................103 Annex 1. Standard operating procedures for the use, care and maintenance of microscopes ...........................................................................................................105 Annex 2. Specification sheet for laboratory equipment ........................................................108 Annex 3. Maintenance service report for laboratory equipment ........................................109 Annex 4. Register for maintenance of laboratory equipment .............................................. 110 Annex 5. Standard operating procedures for storage of rapid diagnostic tests at points of care .........................................................................................................
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