Laboratory malaria diagnostic capacity in health facilities in five administrative zones of Oromia Regional State, Ethiopia

Objectives and methods Quality laboratory services are a requisite to guide rational case management of malaria. Using a pre-tested, standardized assessment tool, we assessed laboratory diagnostic capacity in 69 primary, secondary and tertiary health facilities as well as specialized laboratories in five administrative zones in Oromia Regional State, Ethiopia, during February and March 2009. Results There was marked variability in laboratory diagnostic capacity among the facilities assessed. Of 69 facilities surveyed, 53 provided both comprehensive malaria laboratory diagnosis and outpatient treatment services, five provided malaria microscopy services (referring elsewhere for treatment), and 11 primary care health posts provided rapid diagnostic testing and outpatient malaria treatment. The facilities’ median catchment population was 39 562 and 3581 people for secondary/tertiary and primary health facilities, respectively. Depending on facility type, facilities provided services 24 h a day, had inpatient capacity, and access to water and electricity. Facilities were staffed by general practitioners, health officers, nurses or health extension workers. Of the 58 facilities providing laboratory services, 24% of the 159 laboratory staff had received malaria microscopy training in the year prior to this survey, and 72% of the facilities had at least one functional electric binocular microscope. Facilities had variable levels of equipment, materials and biosafety procedures necessary for laboratory diagnosis of malaria. The mean monthly number of malaria blood films processed at secondary/tertiary facilities was 225, with a mean monthly 56 confirmed parasitologically. In primary facilities, the mean monthly number of clinical malaria cases seen was 75, of which 57 were tested by rapid diagnostic test (RDTs). None of the surveyed laboratory facilities had formal quality assurance/quality control protocols for either microscopy or RDTs. Conclusions This is the first published report on malaria diagnostic capacity in Ethiopia. While our assessment indicated that malaria laboratory diagnosis was available in most facilities surveyed, we observed significant gaps in laboratory services which could significantly impact quality and accessibility of malaria diagnosis, including laboratory infrastructure, equipment, laboratory supplies and human resources. Objectifs et méthodes: Des services de laboratoire de qualité sont une condition nécessaire pour guider la gestion rationnelle des cas de malaria. En utilisant un outil d’évaluation standardisé pré testé, nous avons évalué la capacité de diagnostic des laboratoires dans 69 établissements de santé primaires, secondaires et tertiaires ainsi que des laboratoires spécialisés, dans cinq zones administratives de l’Etat Régional d’Oromia en Ethiopie, en février et mars 2009. Résultats: Il y avait une variabilité marquée dans la capacité de diagnostic des laboratoires entre les établissements évalués. Sur les 69 établissements étudiés, 53 effectuaient à la fois le diagnostic de laboratoire complet de la malaria et des services de traitement ambulatoire, 5 fournissaient des services de microscopie de la malaria (et référaient ailleurs pour le traitement) et 11 postes de soins de santé primaire fournissaient un diagnostic par test rapide et un traitement de la malaria en ambulatoire. Les établissements couvraient des zones médianes de 39.562 et 3.581 personnes pour les établissements de santé secondaire/tertiaire et primaire, respectivement. Selon le type d’établissement, des services de 24 heures par jour, une capacité d’hospitalisation et l’accès à l’eau et l’électricitéétaient disponibles. Les établissements étaient desservis par des médecins généralistes, des agents de santé, des infirmiers ou des agents sanitaires. Sur les 58 établissements offrant des services de laboratoire, 24% (n = 159) du personnel de laboratoire avaient reçu une formation sur la microscopie de la malaria au cours de l’année précédant l’enquête et 72% des établissements avaient au moins un microscope binoculaire électrique fonctionnel. Les établissements avaient des niveaux variables de matériel d’équipement et des procédures de biosécurité nécessaires pour le diagnostic en laboratoire de la malaria. Le nombre moyen mensuel de frottis de sang examinés pour la malaria dans les établissements secondaires/tertiaires était de 225, avec une moyenne mensuelle de 56 confirmés parasitologiquement. Dans les établissements primaires, le nombre mensuel moyen de cas de malaria clinique vus était de 75, dont 57 ont été testés par le test de diagnostic rapide (TDR). Aucun des établissements de laboratoire surveillés n’avaient en place une assurance qualité officielle ou des protocoles de contrôle de qualité ni pour la microscopie ni pour le TDR. Conclusions: Il s’agit ici du premier rapport publié sur la capacité de diagnostic de la malaria en Ethiopie. Bien que notre évaluation indique que le diagnostic de laboratoire de la malaria est disponible dans la plupart des établissements surveillés, nous avons observé des lacunes importantes dans les services de laboratoire qui pourraient considérablement affecter la qualité et l’accessibilité au diagnostic de la malaria, comprenant l’infrastructure des laboratoires, l’équipement, les fournitures de laboratoire et les ressources humaines. Mots-clés: malaria, laboratoire, diagnostic, systèmes de santé, capacité, Ethiopie. Objetivos y métodos: Los servicios de laboratorio de calidad son un requisito a la hora de guiar el manejo racional de los casos de malaria. Utilizando una herramienta estandarizada de evaluación, previamente probada, evaluamos la capacidad diagnóstica de 69 centros sanitarios primarios, secundarios, y terciarios así como laboratorios especializados en cinco zonas administrativas en el Estado Regional de Oromia, Etiopía, durante Febrero y Marzo del 2009. Resultados: Existía una marcada variabilidad en la capacidad diagnóstica de los laboratorios de los diferentes centros evaluados. De 69 centros estudiados, 53 tenían tanto un diagnóstico integral de malaria a nivel de laboratorio como servicios de tratamiento en consultas externas, 5 tenían servicios de microscopía para malaria (refiriendo el tratamiento a otros centros), y 11 centros de atención primaria proveían pruebas diagnósticas rápidas y tratamiento para malaria en consultas externas. La media del área captación de los centros era de 39,562 y 3,581 personas para centros secundarios y terciarios y centros primarios respectivamente. Dependiendo del tipo de centro, se ofrecían servicios 24hrs al día, había posibilidad de ingresar pacientes y acceso a agua corriente y electricidad. Los centros estaban atendidos por médicos generales, enfermeras, responsables sanitarios o agentes de extensión sanitaria. De los 58 centros que proveían servicios de laboratorio, 24% de los 159 empleados de laboratorio habían recibido entrenamiento en microscopía de malaria durante el año anterior al estudio, y 72% de los centros tenían al menos un microscopio binocular eléctrico funcional. Los centros tenían niveles variables de equipamiento, materiales y procedimientos de bioseguridad necesarios para el diagnóstico de malaria en el laboratorio. La media mensual de láminas para malaria procesadas en centros secundarios/terciarios era de 225, con una media mensual de 56 confirmaciones parasitológicas. En centros primarios, la media mensual de casos clínicos de malaria era de 75, de los cuales se les realizó una prueba diagnóstica rápida (PDR) a 57. Ninguno de los centros con laboratorio evaluados tenían protocolos formales de garantía / control de para la microscopía o las PDRs. Conclusiones: Esta es la primera publicación sobre la capacidad de diagnóstico de la malaria en Etiopía. Mientras que nuestra evaluación indica que el diagnóstico de la malaria en laboratorio estaba disponible en la mayoría de los centros evaluados, hemos observado vacíos significativos en los servicios de laboratorio, que podrían impactar de forma significativa sobre la calidad y la accesibilidad del diagnóstico de la malaria, incluyendo la infraestructura de laboratorio, equipos, material de laboratorio y recursos humanos. Palabras clave: Malaria, laboratorio, diagnóstico, sistemas sanitarios, capacidad, Etiopía. Malaria is the most frequent cause of outpatient visits, health facility admissions and inpatient deaths in Ethiopia, accounting for 12% of outpatient visits and 10% of admissions in 2007/2008 (Federal Democratic Republic of Ethiopia Ministry of Health 2008). Rainfall and altitude are the major determinants of malaria epidemiology in the country (Ghebreyesus et al. 2000; Adhanom et al. 2006). Transmission occurs throughout the year in most locations with two distinctive peaks after the short and long rainy seasons in March–May and July–September, respectively (Graves et al. 2009; Peterson et al. 2009). Widespread and large-magnitude epidemics occur every 5–8 years (Negash et al. 2005; Guthmann et al. 2007). In Ethiopia, health services are provided through a four-tiered system comprising specialized referral hospitals, zonal hospitals, district hospitals and primary health care units (PHCUs), with average catchment populations of about 5 000 000, 1 000 000, 250 000 and 25 000 people, respectively. PHCUs consist of district health centres and community-level health posts. The latter focus on preventive services, providing only limited curative services. In 2007, for a total population of 77 million people, there were 143 hospitals [88 and 55 of which were administered by the Federal Ministry of Health (FMOH) and private sector/non-governmental organizations (NGOs), respectively]; 690 health centres (671 FMOH and 15 private sector/NGOs); 1376 health stations; and 9914 health posts. Hospitals and health centres are primarily concentrated in urban areas, whereas health posts are usually situated in rural areas. Hospitals have several cadres of health workers, including physicians (training: 6–7 years), nurses (2–3 years), laboratory technicians (2 years) and technologists (4 years). Health centres are usually staffed by at least one health officer or nurse, laboratory technicians, pharmacists or druggists, and midwives. Health posts are staffed by two female health extension workers (HEWs), i.e. high school graduates with 1-year training on a package of 16 health interventions, including malaria. Most patients with uncomplicated malaria are evaluated and treated at health post and health centre levels. The latter usually has laboratory services providing microscopic examination of blood films, whereas the former relies on malaria rapid diagnostic tests (RDTs). Depending on aeti-ology, malaria cases are treated with the artemisinin-based combination therapy (ACT), artemether-lumefantrine (AL), for Plasmodium falciparum or chloroquine (CQ) for Plasmodium vivax according to national malaria case management guidelines (Federal Democratic Republic of Ethiopia Ministry of Health 2004). Because health centres have inpatient capabilities (albeit limited), they are the first referral point for the health posts for severe malaria cases. Most patients with severe malaria are managed by district and zonal hospitals, where they typically receive systemic quinine therapy. The country’s laboratory services are supported by the Ethiopian Health, Nutrition and Research Institute (EHNRI) through a network of twelve regional reference laboratories (RRLs); currently, the support given is basic and focuses mainly on HIV and tuberculosis, and does not include malaria. EHNRI and its satellite RRLs have a broad mandate ranging from national infectious disease surveillance to public health emergency medicine and, as national reference laboratory, ensuring laboratory services quality control (QC) (EHNRI 2009). Two large grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria [Round 2 (2002–2008) total budget: $73 million and Round 5 (2005–2010) total budget: $140 million], provided funding for Ethiopia to dramatically scale-up malaria prevention and control interventions (Jima & Medhin 2008). This scale-up included the distribution of 12.5 million RDTs and 15.4 million ACT treatment doses to health facilities to increase access and availability of timely malaria diagnosis and effective treatment services (Jima et al. 2010). The initial scale-up of malaria prevention and control efforts in Ethiopia largely focused on the procurement of and access to key malaria commodities, rather than strengthening the support systems (Federal Democratic Republic of Ethiopia Ministry of Health 2006). Currently, no data exist on the reliability of laboratory confirmation of malaria diagnosis in Ethiopia, despite ongoing efforts to strengthen the laboratory quality assurance and quality control (QA/QC) systems. Health workers have variable training in malaria laboratory diagnosis and experience shortages of equipment and supplies that may compromise effective malaria diagnostic and treatment services. Oromia Regional State is the largest of the 11 regional states of Ethiopia, with a population of 27 million people and covering about one-third of the country’s landmass. Because of its malaria burden, Oromia has been the focus state for the US President’s Malaria Initiative (PMI; http://www.pmi.gov). The aim of the survey reported here was to (i) comprehensively assess the capacity of selected health facilities within five zones in Oromia, Ethiopia, to perform malaria laboratory diagnosis and (ii) identify laboratory requirements to develop operational programme activities to support quality malaria case management for patients evaluated at these health facilities. February and March we assessed 69 health facilities within five administrative zones of Oromia, and The surveyed facilities included hospitals, health malaria control centres RRLs and 11 health posts. This of health facilities was selected with the Oromia Regional Health and and distribution of health facilities surveyed in Oromia Regional a pre-tested, The (i) general about the (ii) on type of malaria laboratory services, including availability of human laboratory and clinical equipment and protocols for malaria laboratory of biosafety and and laboratory data from health facility assessment comprising of the for and the and Oromia with and Health malaria the to the survey, the assessment received 1 of on the survey and The survey included key with health and of secondary The data were and in 15 hospitals, health and one provided comprehensive malaria case management and were as referral The RRLs provided laboratory services for and two provided laboratory services patients to or for malaria treatment after laboratory diagnosis by The 11 primary care health posts are typically in rural and these malaria treatment test the data are as clinical referral centres (n = laboratories (n = and health posts (n = The median catchment population of the 53 clinical referral centres was 39 562 people 000 of were 24 h a in of the surveyed facilities and h a for 5 a in the The median number of inpatient was of were 24 h a in of the 58 surveyed facilities with microscopy the laboratories were for h a a was available in facilities, of these reported frequent with at least two Of facilities with access to 16 had a functional Of surveyed had access to with and 5 and well respectively. the facilities reported a either or systems at surveyed at health system at assessed system at one of the assessed health at one of the assessed Health posts surveyed provided clinical services to a median 3581 people not microscopy laboratory services. of of health posts were h a a had water with and two well and respectively. had a with Of the 53 clinical referral facilities, and 53 had general practitioners, health and respectively. reference and guidelines for malaria were available in of surveyed malaria In facilities, health workers had training in RDTs in the total 159 laboratory staff at the 58 microscopy laboratories facilities had at least one laboratory with at least one laboratory and at least one laboratory one laboratory, the in had laboratory with training (n = were available in of the surveyed facilities. staff reported training within the year for malaria microscopy or diagnosis at and 2 of facilities, and 5 training was provided by the in with at the 11 health posts of two (n = one (n = and one (n = at at least one of these health workers had training within 1 Of the surveyed facilities, had at least one electric binocular microscope and 24 had 1 binocular of and were respectively facilities binocular reported microscope observed and in and facilities, respectively. major and laboratory equipment surveyed is in health posts not laboratory services, equipment and supplies are limited to malaria cases with RDTs Of the surveyed facilities with laboratory services, 16 and reported supplies of and microscope respectively. the and RRLs and the Malaria that had supplies and quality of and to and The survey indicated with the of and in 27 and facilities, respectively. facilities reported the capacity to methods of of either or observed on laboratory in 39 of these facilities, laboratory in only five of these facilities. were in equipment in two of these facilities, and laboratory staff were to laboratory management in of these facilities. None of the facilities surveyed had with for equipment of the health posts surveyed had the of at a mean of at the of the In of the health the RDTs had with the mean number of one 25 None of the reported in observed laboratory staff in laboratory a 5 had available not and facilities not have observed of in laboratory at staff not available and at staff not have facilities were available for staff in 27 laboratory facilities observed of and in and facilities, respectively. Of surveyed laboratory facilities, were for and were for in facilities. The primary of for and blood and blood was in and facilities, respectively. of treated blood and blood and of agents was through in and facilities, respectively. health we observed staff in RDTs. materials were and in health posts. Of health one had facilities for and for of Of 58 facilities malaria microscopy laboratory services, microscopy was available at only for of microscopic diagnosis included of functional or of staff in malaria diagnosis was available in 24 of 58 malaria microscopy laboratory centres and of these facilities both microscopy and RDTs for malaria RDTs were in place of microscopy during laboratory microscopy cause in clinical and laboratory staff were not was in 39 facilities, with of and in 27 and of the facilities, respectively. Malaria blood films were in 16 both and blood only blood and one facility only blood surveyed facilities reported for and films, with two facilities for the facilities where blood films were malaria was observed in 39 and reported in facilities, malaria was observed in 11 and reported in facilities. In facilities malaria the system Health was RDTs for malaria were in 16 facilities, we observed of in facilities, a total of 24 facilities. laboratory with laboratory staff in of surveyed facilities, with laboratory personnel usually the malaria tests with the laboratory diagnostic test at and of surveyed facilities treated patients with blood films with and with respectively. the 58 microscopy laboratory facilities, a malaria laboratory in laboratory were at facilities only observed to in of these and the mean monthly number of blood films processed was and the mean monthly number of confirmed malaria cases facility was Of the total confirmed cases at facilities, and 15 were of vivax and the were In assessed health or for malaria test were available in to the mean monthly number of clinical malaria cases seen was health of which a mean 57 were tested by RDTs. None of the surveyed laboratory facilities had formal protocols for either microscopy or RDTs. Of facilities blood films, 25 24 and two for were for in facilities, of these health facility reported of through visits by the Health in the were reported in of surveyed facilities, with only that visits included of malaria microscopy or RDTs as well as on staff by the for malaria blood and was observed in facilities and had for of RDTs. for malaria microscopy were available in had for RDTs. protocols were in health posts surveyed, in health RDTs for tested by were to a for in were at health posts by and in the was reported by health visits included of RDTs in health of which received on from the None of the health posts had or from Global Malaria Malaria and the increase in funding support for malaria prevention and control are malaria prevention and control interventions, including of and of diagnosis and treatment. and both that treatment for malaria and malaria cases in confirmed by laboratory diagnosis Health 2009). the of of malaria after the scale-up of malaria is that only malaria cases receive treatment 2006). exist to malaria diagnosis at et al. requirements for diagnosis may variable for of the health system 2009). is that strengthening malaria diagnosis is for strengthening the of a country’s laboratory services et al. 2009; 2009). on malaria in general diagnostic capacity is with data from assessment available in the & Health of & Institute of Ministry of Health and Ministry of Health & 2008). on malaria diagnostic capacity from in have been by the Malaria from which the for this survey was While our assessment indicated that malaria laboratory diagnosis, either by microscopy or was available in most facilities surveyed the assessment significant gaps in laboratory that could impact on quality and accessibility of malaria diagnosis, as laboratory infrastructure, equipment, laboratory supplies and human resources. as here and to strengthen laboratory capacity to malaria et al. 2007). of the and gaps are of than access to and may of laboratory or and support availability of staff and from this assessment have been to and activities to strengthen laboratory capacity for malaria diagnosis in Oromia, facilities with have been with microscope and laboratories have been provided with of laboratory and supplies to that blood examination is not clinical and laboratory facility staff are in malaria diagnostic laboratory and quality assessment system has been Health and Nutrition Research Institute and is the of EHNRI and in with and the in to from RDTs of falciparum to RDTs of both falciparum and falciparum et al. malaria case While of RDTs at the in or is a to the system in place to the quality of RDTs at Health and Nutrition Research Institute 2010). as or the of & Institute of Ministry of Health and Ministry of Health & are to requirements to strengthen of health services including a country’s capacity for malaria laboratory and health systems strengthening efforts are for malaria and in Ethiopia. are to for for and US for for on the The was supported by the through the US for the Malaria The in this are of the and may not the of organizations of of