SOP â Malaria Microscopy - NVBDCP

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Quality Assurance of Malaria Diagnostic tests4.5.1 Assessment of Human ResourcesA well organized QA programme does not always guarantee improvement oflaboratory work unless there are committed trained and disciplined staff, whounderstand the purpose of QA and do not ignore the results of QA. Training will beprovided to all staff under the network according to national guidelines. Initial basictraining must be supplemented by regular supervision and re-training by refreshercourses. A trained staff should be designated as Quality Control (QC) officer.4.5.2 Standard Operating Procedures (SOP).This operational manual for SOP has been prepared to strengthen the laboratoriesengaged in diagnosis of malaria, in order to bring a qualitative improvement insensitivity and specificity of the techniques being used under the programme. It aimsto meet the norms and criteria laid by WHO for quality laboratory services for malariaand includes all aspects of IQC, EQAS and documentation. NVBDCP envisage thatthese procedures should be followed for each activity pertaining to malaria laboratorydiagnosis and these should be on the laboratory table of the LT. These may also beused as troubleshooting guides for equipment, reagents and methods.4.5.3 Internal Quality Control (IQC) :• all testing laboratories should adhere to IQC procedures within each laboratory in thenetwork with strict control of techniques and equipment as per the National SOP toensure reproducibility and sensitivity of detection.• periodic training and retraining of microscopists/laboratory staff should be ensured.• availability of equipment in functioning state and good quality stains/kits should beensured.• in case of microscopy, the quality of each prepared slide is assessed at the time ofmicroscopic examination. Whenever possible, any slide that is inadequately spreadshould be prepared again until a slide of an acceptable standard is produced.• the Coordinator of each malaria Reference Laboratory at national/ regional/state levelmust ensure systematic compliance with the norms for IQC. In peripheral laboratories(PHC/CHC), the MO I/c / LT must assume this responsibility.• troubleshooting guides for equipment, reagents and methods would be usefuladditions to the more isolated laboratories where instant help is not available.• with a multitude of steps involved in processing of a specimen, errors can occur atany stage. Laboratory management needs to be aware where errors can happen toreduce the possibility of their occurrence and monitoring all stages from thepreparation through the examination up to the results. In case of microscopy,whenever required, reference slides and coloured charts supplied by Dte of NVBDCPshould be followed.• frequency and magnitude of incorrect results may be determined: in case ofmicroscopy by independent cross-checking of the results of a proportion of theroutine slides by some senior staff in the laboratory, if present.4.5.4 External Quality Assurance schemes (EQAS)• EQAS should be carried out at all levels of the national laboratory network forchecking of accuracy of results.• results of each round of EQAS should result in prompt feedback and corrective actionat all levels where problems were encountered.SOP – Malaria Microscopy© Copyright to Dte. NVBDCP Only. Any modification are prohibited
Quality Assurance of Malaria Diagnostic tests• participation of each laboratory in periodic (annual) EQAS organized by the NRL willbe mandatory. In turn, the NRL should be subjected to EQAs by some internationallaboratory.• staff of all laboratories at Regional/state/ district and those at the peripheral level(PHC/CHC) for malaria microscopy will be subject to national assessment by threeprocesses.4.5.4.1. Performance evaluation:4.5.4.1.1 Proficiency testingThis will be carried out through analysis of known but coded panel slides (high qualitystained blood slides), representing all the species present in the region, differentparasite densities, mixed infections and also negative slides. The NRL will preparethese according to standardized procedures and will send them for a fixed number oftimes per year, (not less than twice a year), to each participating laboratory wheremicroscopists are to be assessed. These slides are examined by the same staffusing the same procedures as normal specimens of the same type. The results ofthese tests will be dispatched to the National Reference Centre/ Institutionconcerned, within a specified time, for comparison with the national identities of eachslide after decoding. This method checks the accuracy of the test results. Resultsfrom a laboratory might be highly reproducible but consistently incorrect. Feed backwould be sent promptly to correct the results.Slide banks of unimpeachable quality with their content validated at NIMR would beutilized for training as well as for support assessment of microscopists. Such codedslides prepared according to SOPs, would be acquired by NIMR throughits field stations, as they have access to the required range of Plasmodium species.NIMR should also be capable of providing coded and matching negative slides tomake standardized and high-quality slide sets that can be used for EQAS. Theseslides must be cross-checked to ensure the accuracy of the original diagnosis. Itshould contain the slides of all the three human species of malaria parasites Pf, Pv,Pm (prevalent in India) in thick and thin smears with different parasiteamia level,including rare forms of Pf, mixed infections and negative slides as well.4.5.4.1.2 CrosscheckingQC by cross checking of slides taken routinely by the laboratory services can behighly demanding on human and financial resources. The intermediate or NationalReference Centers will handle the results of the indirect QC of slides prepared,stained and analysed by each laboratory. Earlier all positive and 10% of negativeslides were sent to Zonal/ROH&FW laboratory for cross checking every month. Theproposed scheme would follow revised quantitative criteria of cross checkingof all positive and 5% of negative slides. Feed back of results is sent promptly bythe supervisor in order to take corrective action (see SOP: M 8 for more details)4.5.4.2 SupervisionSupervision of efficiency of laboratory is an important component of the programme.For this, a supervisory LT at district/zonal/state laboratories will be deputed to visitSOP – Malaria Microscopy© Copyright to Dte. NVBDCP Only. Any modification are prohibited
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SOP â Malaria Microscopy - NVBDCP