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

Malaria Journal Wanja et al. Malar J (2017) 16:221 DOI 10.1186/s12936-017-1856-2 Open Access RESEARCH Evaluation of a laboratory quality assurance pilot programme for malaria diagnostics in low‑transmission areas of Kenya, 2013 Elizabeth Wanja1, Rachel Achilla1,2, Peter Obare1,2^, Rose Adeny1,2, Caroline Moseti1,2, Victor Otieno1,2, Collins Morang’a1,2, Ephantus Murigi3, John Nyamuni3, Derek R. Monthei1, Bernhards Ogutu1,2 and Ann M. Buff4,5* Abstract Background: One 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. Methods: From 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. Results: Eighty (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. Conclusions: Significant 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. Keywords: Malaria, Microscopy, Quality assurance, Accuracy, Laboratory, Kenya *Correspondence: ^ Posthumously 5 U.S. President’s Malaria Initiative, United Nations Avenue, Village Market, P. O. Box 606, Nairobi 00621, Kenya Full list of author information is available at the end of the article © The Author(s) 2017. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/ publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Wanja et al. Malar J (2017) 16:221 Background In Kenya, malaria accounts for more than 20% of outpatient visits, 19% of hospital admissions, and 3–5% of hospital deaths and is a leading cause of mortality in children less than 5 years of age [1, 2]. Approximately 70% of the population in Kenya lives in areas at risk of malaria transmission [3]. Prompt and accurate diagnosis of malaria is an important component of malaria case management. In 2010, the World Health Organization (WHO) recommended that all patients with suspected uncomplicated malaria should receive a parasitological test prior to treatment [4]. Correct diagnosis of malaria reduces unnecessary treatment with expensive artemisinin-based combination therapy (ACT), helps prevent the development of drug resistance and increases the likelihood of correct treatment for other febrile illnesses [4, 5]. Both the WHO policy on malaria diagnostics and the Kenya National Malaria Strategy 2009–2017 recommend the use of microscopy and quality-controlled malaria rapid diagnostic tests (RDT) for parasitological diagnosis of malaria [3, 4]. Microscopy has been the primary method for malaria diagnosis historically and was available in 56% of health facilities in Kenya in early 2013 [6]. Microscopy requires well-trained microscopists as well as functional equipment, supplies and electricity [5]. Training of staff in centres of excellence can improve the capacity of individual microscopists; however, when trained microscopists return to health-facility laboratories, they often face many challenges such as poor-quality reagents, non-functional equipment, heavy workloads and lack of trust in results by clinicians [5, 7]. These challenges can contribute to the marginal improvements in the performance observed after training. The lack of institutional laboratory quality assurance programmes and structured periodic supportive supervision to identify problems and take corrective actions also contribute to the slow progress toward improving access to quality malaria diagnostics [5, 8]. Malaria RDTs are recommended by WHO due to affordability, availability and accuracy [9, 10]. In early 2013, only 31% of health facilities in Kenya had malaria RDTs, but 76% of health facilities had either functional microscopy or RDTs available [6]. One objective of the Kenya National Malaria Strategy 2009–2017 is scaling and sustaining access to prompt diagnosis and effective treatment to the entire population [3]. Part of the implementation of the national strategy has been to strengthen laboratory diagnosis of malaria across all levels of the health care system and in all epidemiological zones. Beginning in June 2013, the National Malaria Control Programme (NMCP), Ministry of Health (MOH), implemented a pilot malaria diagnostics quality assurance (QA) programme. The QA programme was implemented Page 2 of 13 first in health facilities in low-transmission areas because routine health data showed that over-diagnosis of malaria was common despite a low prevalence of parasitaemia [11, 12]. The trends in improvements and challenges after the pilot phase of the QA programme implementation in low-transmission areas from Jun (...truncated)