Early diagnosis and prompt, effective treatment is the basis for the management of malaria and key to reducing malaria mortality and morbidity. Demonstration of the presence of malaria parasites prior to treatment with antimalarial drugs is fundamental this goal, as clinical diagnosis has poor accuracy and leads to over-diagnosis of malaria with resultant poor management of non-malarial febrile illness and wastage of antimalarial drugs. While microscopy remains the mainstay of parasite-based diagnosis in most large health clinics and hospitals, the quality of microscopy-based diagnosis is frequently inadequate for ensuring good health outcomes and optimal use of resources.

An acceptable microscopy service is one that is cost-effective, provides results that are consistently accurate and timely enough to have a direct impact on treatment. This requires a comprehensive and active quality assurance (QA) programme.

The primary aim of malaria microscopy QA programmes is to ensure that microscopy services are manned by competent and motivated staff, supported by effective training and supervision that maintains a high level of staff competency and performance and by a logistics system that provides and maintains an adequate supply of reagents and equipment.

A programmes must be:

• sustainable
• compatible with the needs of each country
• able to fit into the structure of existing laboratory services.

A QA programme should appropriately recognize and accredit good performance, identify laboratories and microscopists with serious problems which result in poor performance, establish regional or national benchmarks for quality of diagnosis and central reporting of indicators including accuracy, equipment and reagent performance, stock control and workload.

This manual is designed primarily to assist managers of national malaria control programmes and laboratory services to develop and maintain a sustainable malaria microscopy QA programme. It outlines a hierarchical structure based on re-training, validation, and the development of competency standards designed to ensure the quality of diagnosis necessary for a successful malaria programme, while remaining within the financial and personnel resources likely to be available. Without an efficient QA programme, resources spent on diagnostic services are likely to be wasted and clinicians will have no confidence in the results.

The mode of implementation of the QA system outlined in this manual will vary according to the organization of the national laboratory services dealing with malaria, which may fall under the national malaria control programme, or under a separate laboratory structure working closely with the malaria programme. The microscopists may be tertiary trained laboratory technicians performing a range of specialized diagnostic activities, or health workers trained specifically in malaria microscopy without wider laboratory roles. In either case, the principles remain the same.

At a minimum, a malaria microscopy QA programme should include the following.

• A central coordinator(s) to oversee QA.
• A reference (core) group of microscopists at the head of a hierarchical structure, supported by an external QA programme and with demonstrable expertise in overseeing programme training and validation standards.
• Good initial training with competency standards that must be met by trainees prior to operating in a clinical setting.
• Regular retraining and assessment/grading of competency, supported by a well validated reference slide set (slide bank).
• A sustainable cross-checking (validation) system that detects gross inadequacies without overwhelming validators higher up the structure, with good feed-back of results and a system to address inadequate performance.
• Good supervision at all levels.
• Good logistical management, including supply of consumables and maintenance of microscopes.
• Clear standard operating procedures (SOPs) at all levels of the system.
• An adequate budget is required as an essential part of funding for malaria case management.
• The manual describes the essential elements necessary to put this structure in place.