title: Tuberculosis Laboratory Diagnosis Quality Assurance among Public Health Facilities in West Amhara Region, Ethiopia.
abstract: BACKGROUND
  Reliable smear microscopy is an important component of Directly Observed Treatment Scheme (DOTS) strategy for TB control program in countries with limited resources. Despite external quality assessment is established in Ethiopia, there is lower TB detection rate (48%) in Amhara region compared to the World Health Organization (WHO) estimate (70%). This highlights the quality of smear microscopy needs to be evaluated. Therefore, the aim of this study was to assess the quality of sputum smear microscopy performance among health center laboratories in West Amhara region, Ethiopia.
  
  
  METHODS
  A cross sectional study was conducted from July 08, 2013 to July 07, 2014. Data were collected from 201 public health center laboratories using a structured questionnaire. Slides were collected based on Lot Quality Assurance Sampling (LQAS) method and rechecked blindly by trained laboratory technologists. The data were entered into EPI info V.7 and smear quality indicators and AFB results were analyzed by SPSS version 20.
  
  
  RESULTS
  Among 201 laboratories enrolled in this study, 47 (23.4%) laboratories had major errors. Forty one (20.4%) laboratories had a total of 67 false negative and 29 (14.4%) laboratories had a total of 68 false positive results. Specimen quality, smear thickness and evenness were found poor in 134 (66.7%), 133 (66.2%) and 126 (62.7%) laboratories, respectively. Unavailability of microscope lens cleaning solution (AOR: 2.90; 95% CI: 1.25-6.75; P: 0.013) and dirty smears (AOR: 2.65; 95% CI: 1.14-6.18; P: 0.024) were correlated with false negative results whereas no previous EQA participation (AOR: 3.43; 95% CI: 1. 39-8.45; P: 0.007) was associated with false positive results.
  
  
  CONCLUSIONS
  The performance of health facilities for sputum smear microscopy was relatively poor in West Amhara region. Hence, strengthening the EQA program and technical support on sputum smear microscopy are recommended to ensure quality tuberculosis diagnostic service.
authors.affiliation: Bahir Dar Regional Health Research Laboratory Center, Bahir Dar, Ethiopia.
authors.forename: Melashu Balew
authors.initials: MB
authors.lastname: Shiferaw
authors.affiliation: Bahir Dar Regional Health Research Laboratory Center, Bahir Dar, Ethiopia.
authors.forename: Hiwot Amare
authors.initials: HA
authors.lastname: Hailu
authors.affiliation: Walter and Eliza Hall institute of medical research, Melbourne, Australia.
authors.forename: Abebe Alemu
authors.initials: AA
authors.lastname: Fola
authors.affiliation: Bahir Dar Regional Health Research Laboratory Center, Bahir Dar, Ethiopia.
authors.forename: Mulatu Melese
authors.initials: MM
authors.lastname: Derebe
authors.affiliation: Bahir Dar Regional Health Research Laboratory Center, Bahir Dar, Ethiopia.
authors.forename: Aimro Tadese
authors.initials: AT
authors.lastname: Kebede
authors.affiliation: Amhara Regional State Health Bureau, Bahir Dar, Ethiopia.
authors.forename: Abayneh Admas
authors.initials: AA
authors.lastname: Kebede
authors.affiliation: Bahir Dar Regional Health Research Laboratory Center, Bahir Dar, Ethiopia.
authors.forename: Manamnot Agegne
authors.initials: MA
authors.lastname: Emiru
authors.affiliation: Bahir Dar Regional Health Research Laboratory Center, Bahir Dar, Ethiopia.
authors.forename: Zelalem Dessie
authors.initials: ZD
authors.lastname: Gelaw
mesh_terms: D001431:Bacteriological Techniques / Q000592:standards*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D003430:Cross-Sectional Studies; D005002:Ethiopia / Q000453:epidemiology; D006801:Humans; D007753:Laboratories / Q000592:standards*; D059021:Laboratory Proficiency Testing; D055810:Lot Quality Assurance Sampling; D008853:Microscopy; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification*; D011786:Quality Control; D013183:Sputum / Q000382:microbiology*; D014376:Tuberculosis / Q000175:diagnosis* / Q000453:epidemiology / Q000382:microbiology