The Quality of Sputum Smear Microscopy in Public-Private Mix Directly Observed Treatment Laboratories in West Amhara Region, Ethiopia

April The Quality of Sputum Smear Microscopy in Public-Private Mix Directly Observed Treatment Laboratories in West Amhara Region, Ethiopia Almaw Manalebh 0 1 Meaza Demissie 0 1 Daniel Mekonnen 0 1 Bayeh Abera 0 1 0 1 USAID-Ethiopia, Private Health Sector Programme, Bahir Dar, Ethiopia, 2 Addis Continental Institute of Public Health , Gondar , Ethiopia , 3 Departments of Medical Microbiology, Parasitology and Immunology, College of Medicine and Heath Sciences, Bahir Dar University , Bahir Dar , Ethiopia 1 Academic Editor: Selvakumar Subbian, Public Health Research Institute at RBHS, UNITED STATES Ethiopia adopted Public-Private Mix Directly Observed Treatment Short Course Chemotherapy (PPM-DOTS) strategy for tuberculosis (TB) control program. Quality of sputum smear microscopy has paramount importance for tuberculosis control program in resourcepoor countries like Ethiopia. A cross-sectional study was conducted to assess the quality of sputum smear microscopy in 37 Public-Private Mix laboratories in West Amhara, Ethiopia. The three external quality assessment methods (onsite evaluation, panel testing and blind rechecking) were employed. Onsite assessment revealed that 67.6% of PPM-DOTS laboratories were below the standard physical space (5 X 6) m2. The average monthly workload per laboratory technician was 19.5 (SD2.9) slides with 12.8% positivity rate. The quality of Acid Fast Bacilli (AFB) staining reagents was sub-standard. The overall agreement for blind rechecking of 1,123 AFB slides was 99.4% (Kappa = 0.97). Reading of 370 AFB panel slides showed 3.5% false reading (Kappa = 0.92). Moreover, the consistency of reading scanty bacilli slides was lower (93%) compared to 1+, 2+ and 3+ bacilli. Based on blind rechecking and panel testing results, PPM-DOTS site laboratories showed good agreement with the reference laboratory. Physical space and qualities of AFB reagents would be areas of intervention to sustain the quality of sputum smear microscopy. Therefore, regular external quality assessment and provision of basic laboratory supplies for TB diagnosis would be the way forward to improve the quality of sputum smear microscopy services in PPMDOTS laboratories. - Competing Interests: The authors declare that they have no competing interests. Tuberculosis (TB) is a chronic infectious disease caused by Mycobacterium tuberculosis [1]. The main source of infection is untreated smear-positive pulmonary tuberculosis patients discharging M. tuberculosis. In Ethiopia, tuberculosis is a major public health problem; therefore, health facility laboratories are integrated in the national TB control program [1, 2]. Ethiopia adopted the Stop TB strategy of World Health Organization (WHO), which is Public-Private Mix Directly Observed Treatment (PPM-DOTS) in 2006 [3], but DOTS was limited only to government sector health facilities. In Ethiopia, private health sectors have employed 55% of general practitioners, 65% of specialists and 79% of laboratory technicians [4]. Expanding TB care services to the private sector has increased access for clients who are reluctant to visit public health facilities due to fear of stigma and perception of unsatisfactory quality of health care services [5]. Sputum smear microscopy is a key component of DOTS in developing countries like Ethiopia [6]. Thus, in countries with a high prevalence of TB, sputum smear microscopy remains the most cost-effective tool for diagnosing and treatment of TB [3]. However, it detects only 20.5% to 74.2% of culture positive TB cases [7, 8], and functions well in quality assured system to produce accurate, reliable and reproducible laboratory results [3]. In Ethiopia, according to the assessment conducted in 2011, 317 PPM-DOTS facilities provide TB diagnosis and treatment services [9]. The highest number of PPM-DOTS facilities (28.4%) was found in Amhara National Regional State, where this study was conducted. In Ethiopia, between August 2006 to and July 2011, 61,525 (9.1%) TB cases were diagnosed in private health facilities [4]. Poor quality sputum microscopy services may result in failure to detect persons with active tuberculosis and unnecessary anti-TB treatment for non-TB cases. In addition, errors in reading sputum microscopy may result in prolonged treatment, or unnecessary treatment termination which predisposes the development of drug resistant tuberculosis (MDR-TB) [6, 10]. Various factors including infrastructure, work experience in sputum smear microscopy and reagents supplies affect the quality of sputum smear microscopy [11]. There is no documented information on the quality of sputum smear microscopy in PPM-DOTS site laboratories in the country especially in the study area. Therefore, this study was conducted to assess the quality of sputum smear microscopy in public-private mix laboratories in West Amhara, Ethiopia. Materials and Methods A cross-sectional study was carried out in six administrative zones in July 2013, West Amhara, Ethiopia. This study included 4 general hospitals, 11 higher clinics and 22 medium clinics. Medium and higher clinics were categorized under primary health care unit in private health sectors. Their service package was mainly basic curative services. Medium clinics were staffed by medium level health professionals, while higher clinics were staffed by higher level medical specialists. From 42 PPM-DOTS sites, 37 were included in this study, but the other 5 sites (4 medium and 1 higher clinics) were excluded using exclusion criteria. The study sites included 37 PrivatePublic DOTS site laboratories that provide TB diagnostic service in Western Amhara. Inclusion and Exclusion Criteria All PPM-DOTS site laboratories providing sputum smear microscopy service were included. However, PPM-DOTS sitelaboratories providing sputum smear microscopy service less than one year were excluded. Slide sample size determination and sampling AFB slide sample size for blind rechecking was calculated using the Lot Quality Assurance Sampling (LQAS) method and the national TB external quality assurance (TBEQA) guidelines [10]. Thus, 1123 AFB slides were determined to run blind rechecking. The numbers of slides from each facility were taken based on annual negative slide volume (ANSV) and slide positivity rate (SPR) [10]. Slides from each PPM-DOTS site laboratory were selected by systematic random sampling method from a list of sputum samples processed between January 1, 2013 and June 30, 2013 in TB laboratory log books. Data Collection tools and procedures External quality assessment methods (blinded rechecking, panel testing and onsite evaluation) were used to assess the quality of sputum smear microscopy in PPM-DOTS sites. Blind rechecking of AFB slides Slides for random blind rechecking were selected according to PPM-DOTS site, AFB positivity slide rate and annual AFB negative slides [10]. Randomly selected slides were kept in slide boxes and then taken to Bahir Dar Regional Health Resear (...truncated)