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
A programmes must be:
- 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.