Evaluation of a laboratory quality assurance pilot programme for malaria diagnostics in low-transmission areas of Kenya, 2013

Abstract

BackgroundOne objective of the Kenya National Malaria Strategy 2009–2017 is scaling access to prompt diagnosis and effective treatment. In 2013, a quality assurance (QA) pilot was implemented to improve accuracy of malaria diagnostics at selected health facilities in low-transmission counties of Kenya. Trends in malaria diagnostic and QA indicator performance during the pilot are described.MethodsFrom June to December 2013, 28 QA officers provided on-the-job training and mentoring for malaria microscopy, malaria rapid diagnostic tests and laboratory QA/quality control (QC) practices over four 1-day visits at 83 health facilities. QA officers observed and recorded laboratory conditions and practices and cross-checked blood slides for malaria parasite presence, and a portion of cross-checked slides were confirmed by reference laboratories.ResultsEighty (96%) facilities completed the pilot. Among 315 personnel at pilot initiation, 13% (n = 40) reported malaria diagnostics training within the previous 12 months. Slide positivity ranged from 3 to 7%. Compared to the reference laboratory, microscopy sensitivity ranged from 53 to 96% and positive predictive value from 39 to 53% for facility staff and from 60 to 96% and 52 to 80%, respectively, for QA officers. Compared to reference, specificity ranged from 88 to 98% and negative predictive value from 98 to 99% for health-facility personnel and from 93 to 99% and 99%, respectively, for QA officers. The kappa value ranged from 0.48–0.66 for facility staff and 0.57–0.84 for QA officers compared to reference. The only significant test performance improvement observed for facility staff was for specificity from 88% (95% CI 85–90%) to 98% (95% CI 97–99%). QA/QC practices, including use of positive-control slides, internal and external slide cross-checking and recording of QA/QC activities, all increased significantly across the pilot (p < 0.001). Reference material availability also increased significantly; availability of six microscopy job aids and seven microscopy standard operating procedures increased by a mean of 32 percentage points (p < 0.001) and 38 percentage points (p < 0.001), respectively.ConclusionsSignificant gains were observed in malaria QA/QC practices over the pilot. However, these advances did not translate into improved accuracy of malaria diagnostic performance perhaps because of the limited duration of the QA pilot implementation.Electronic supplementary materialThe online version of this article (doi:10.1186/s12936-017-1856-2) contains supplementary material, which is available to authorized users.

Factors associated with malaria microscopy diagnostic performance following a pilot quality-assurance programme in health facilities in malaria low-transmission areas of Kenya, 2014

“…Another important limitation was that slide preparation quality, including the stain type and adequacy, was not evaluated. Although both NMCP and WHO recommend Giemsa preferentially for malaria microscopy, the use of both Giemsa and Field stains was common in health facilities [ 8 , 10 , 16 ]. Slides were not matched on parasite density either.…”

“…Twenty-one facilities were part of the pilot QA programme from June to December 2013; these facilities were randomly selected from among 45 public-sector pilot QA programme facilities across 4 service-provision levels (i.e., dispensary, health centre, primary hospital, secondary hospital). The pilot QA programme was implemented in 83 health facilities (45 [54%] public-sector and 38 [46%] private-sector); facilities were selected to participate based on capacity to perform malaria microscopy and distance from the QA officers’ primary duty stations [ 16 ]. These facilities are referred to as ‘QA-pilot facilities.’ Twenty-one public health facilities of the same service-provision level and located in the same county as the QA-pilot facilities, but which did not participate in the QA-pilot programme, were also randomly selected to participate in the survey.…”

“…Laboratory QA programmes have been shown to improve the diagnosis of malaria and, in particular, microscopy accuracy [ 13 , 15 ]. Components of the 7-month pilot QA programme included 4 1-day visits by trained QA laboratory officers, who promoted internal QA/quality control (QC) processes, provided supportive supervision and on-job training, and cross-checked at least 10 malaria microscopy slides at each visit [ 8 , 14 , 16 ]. The pilot QA programme implementation is described in detail elsewhere [ 16 ].…”

“…Components of the 7-month pilot QA programme included 4 1-day visits by trained QA laboratory officers, who promoted internal QA/quality control (QC) processes, provided supportive supervision and on-job training, and cross-checked at least 10 malaria microscopy slides at each visit [ 8 , 14 , 16 ]. The pilot QA programme implementation is described in detail elsewhere [ 16 ]. Independently in 2013, there were other laboratory-strengthening activities ongoing in Kenya, such as malaria microscopy refresher trainings and the WHO Stepwise Laboratory Improvement Progress Towards Accreditation (SLIPTA) programme.…”

Performance Outcomes from Africa-Based Malaria Diagnostic Competency Assessment Courses

“…Previous research has demonstrated the effectiveness of malaria microscopy refresher training on improving technician performance, 13,[31][32][33][34][35][36][37] although some studies have not been able to corroborate this effect. [38][39][40][41] This study adds to the evidence base for malaria microscopy assessments by broadening the scale of outcome measures related to the intervention in exploring both slide-and person-level results. The primary outcome evaluates the competence of participating laboratory technicians through assessment of three major malaria microscopy diagnosis areas (i.e., parasite detection, species identification, and parasite quantification).…”