Malaria diagnostic capacity in health facilities in Ethiopia

Globally, an estimated of 3.4 billion people live in areas at risk of malaria. In 2012 there were 207 million cases of malaria and 627, 000 deaths; 90% of these deaths occurred in sub-Saharan Africa [1]. Approximately 75% of Ethiopia’s landmass is endemic for malaria transmission, with 58 million people at risk of infection and disease [2]. Malaria is one of the top ten causes of morbidity, accounting for 17% of all cases and 8% of health facility admissions in 2012 [3].

Accurate early diagnosis and prompt treatment of malaria is among the core strategies to prevent and control malaria [4]. Despite significant funding for HIV/AIDS, tuberculosis and malaria in the past decade (e. g. through the Global Fund to Fight AIDS, Tuberculosis and Malaria; the U.S. President’s Emergency Plan for AIDS Relief and President’s Malaria Initiative), laboratory systems in developing countries remain weak. Major challenges include poor physical infrastructure and inadequate supplies of materials and reagents, limited human capacity, lack of policies and strategic plans, and limited synergies between clinical and laboratory services [5, 6]. Strong laboratory systems not only ensure that curative interventions are more effective (e. g., by avoiding prescription of artemisinin combination therapy (ACT) to patients with non-malarial causes of fever), but also affect treatment-seeking behaviour (i. e. health facilities with a strong laboratory service tend to experience greater access by patients than facilities with a weak laboratory service) [7].

Following the WHO recommendations of universal diagnostic testing for all suspected malaria cases [8], Ethiopia scaled up diagnostic testing for malaria at all levels of the public sector’s health service delivery system: multispecies rapid diagnostic tests (RDTs) are used at community-level health posts and malaria microscopy is carried out at district-level health centres as well as district-, zonal- and regional-level hospitals [9].

Microscopy requires a functional laboratory set-up with quality diagnostic services and trained laboratory personnel [5]. Published peer-reviewed literature on in-country laboratory capacity, including for malaria, is scarce. Existing data comes almost exclusively from grey literature [10‐13], showing low malaria microscopic diagnostic capacity that ranges from 25% in Uganda, to 33% in Tanzania and 37% in Rwanda. In 2009, assessment of malaria diagnosis capacity in 69 health facilities in Oromia Regional State showed that although most facilities (i. e. 51 (88%)) did provide malaria microscopy services, they faced a myriad of challenges, including limitations in trained personnel, functional laboratory equipment and microscopes, standard operating procedures (SOP) and guideline availability, and continuous supply of necessary reagents and materials [14].

The objective of the survey presented here was to expand the assessment of malaria diagnostic capacity beyond the five administrative zones of Oromia covered in 2009 to facilities within all of Oromia’s 18 zones, as well as Dire Dawa City Administration.

Strong national health laboratory capacity is crucial to prevent, manage and ultimately control diseases such as malaria. In Ethiopia, 4,782,064 (47%) of the 10,088,744 total cases of suspected malaria were diagnosed using microscopy at the health centres or hospitals in 2012 [15]. The findings of the survey reported here confirm major findings from a previous, smaller assessment establishing a laboratory capacity-strengthening programme in Oromia. Although malaria laboratory diagnostic services were available in all facilities surveyed, significant gaps were observed in laboratory infrastructure, equipment, materials and reagent supply chains, human resource capacity, availability of policies, strategic plans and operational procedures, and laboratory services and data recording. This limitation clearly could be one of the main explanations as to why proportion of suspected malaria cases in Ethiopia remain unconfirmed and are treated presumptively.

Availability of water and electricity in assessed laboratories was high (>70%), but laboratory services were reportedly undermined by the frequent interruption of power and water, particularly if a back-up solution (e g, electric generators) was not available. Similarly to the assessment in 2009, a number of laboratories was observed to have gaps in equipment, materials and reagents (Tables 1, 2 nd 3), and some facilities were not able to provide certain services at all or, in the case of shortages, during certain times of the year. Thus, even though the national policy [3] states that microscopy should be used at health centre and hospital levels, more than half of surveyed facilities used RDTs, partially because functional microscopes were not available.

All laboratory personnel had at least diploma level training (i. e., two years). Pre-service training tends to focus on the technical theory of general laboratory skills (e. g., types of diagnostic tests, including haematology, chemistry) rather than developing practical malaria laboratory diagnosis skills (e. g., slide reading, species identification and parasite counting). While in-service training tends to be more practical, there is limited opportunity for in-service training; only a few facilities, had at least one staff participating in malaria microscopy refresher training during the previous year, quarter of the staff were provided with supportive supervision, and 12 (10%) were included in an EQA that involved external re-reading of slides. Although in-service training cannot replace comprehensive pre-service training, a well-thought-out, in-service training curriculum can significantly improve blood slide preparation and accuracy of microscopy [17]. Laboratory test requests are made for suspected malaria cases in all of the 122 health facilities, but against national policy ACT and chloroquine were still prescribed in a significant number of health facilities for suspected patients testing negative. Similar behaviour has been reported in numerous other malaria-endemic countries, including Tanzania and Zambia [18‐21], which clearly undermines malaria prevention, case management and control efforts, as well as being medical malpractice (e. g., delaying treatment of infections of non-malarial aetiology could potentially result in deaths). Importantly, several studies have shown that withholding anti-malarial treatment of RDT-negative patients does not result in increased morbidity and mortality [22, 23]. Generally, the findings indicate that clinicians do not rely on laboratory test results, because of malfunctioning and poorly maintained equipment [24], limited training of laboratory personnel, poor laboratory QA [19], lack of competency in clinical training or practice for malaria case management as shown here and elsewhere [25, 26].

Only a few health facilities had SOPs, guidelines, bench and job aids for reference purposes. Coupled with the abovementioned challenges in infrastructure, equipment, reagents, supervision, and training, it was not surprising that a large proportion of health facilities were ranked as either good or poor when evaluated through the quality of prepared malaria microscopy slides.

Going forward, the malaria laboratory diagnosis and QA programme will focus on addressing needs and gaps identified that can be easily addressed, including supply of equipment (e. g., microscopes), reagents and materials (e. g., gloves, stains, slides), human resource capacity (e. g., through in-service training of laboratory and clinical staff, and supportive supervision), and availability of guidelines and job aids. Additionally, collaboration with EPHI and ORHB to implement an EQA scheme, which is currently being rolled out across Ethiopia, and availability and use of the updated National Malaria Case Management Guidelines at all levels in the health system will be strengthened [4]. Other needs and gaps, including rehabilitation of facilities, provision of continuous water and electricity, and provision of laboratory personnel will need additional financial investment. Together with the continued roll-out of multispecies RDTs at community level, it is hoped that increasing the laboratory capacity of health facilities through QA programmes [27] will ensure that fever cases in Ethiopia are increasingly accurately diagnosed. This should increase health service delivery overall, access of facilities by patients, as well as decrease the total cost of diagnosis and treatment (potentially by up to 46%) [28].

It could be considered that a possible caveat of the study is its design, i.e. a purposefully sampled number of facilities. However, given the number of facilities surveyed over an extensive geographic area, the findings’ likeness to a smaller, earlier study, as well as the study team’s knowledge of the context and infrastructure, the authors do not believe that the study’s outcome would have been different if another random selection of facilities would have been surveyed. Moreover, while they acknowledge that respondent bias may be questioned, the tool included a checklist that directed the study team to directly observe much of the facilities’ infrastructure, services and practices.

The large investment in HIV/AIDS, tuberculosis and malaria has resulted in a dramatic scale-up of disease prevention (e g, long-lasting insecticide-treated nets for malaria) and curative services to remote populations. Unfortunately, laboratory capacity and services have not always kept pace with this expansion. The current standardized assessment provided a snapshot of laboratory capacity across sampled facilities in Ethiopia, showing significant gaps in supplies and equipment, as well as quality assurance and supportive supervision for malaria diagnosis. While baselines such as these are important in order to monitor and evaluate the impact of operational laboratory strengthening programming over time, they also show the multi-faceted challenges that such programming need to address in order to ensure that patients are correctly diagnosed and ultimately treated.