Tuberculosis Laboratory Diagnosis Quality Assurance among Public Health Facilities in West Amhara Region, Ethiopia

• Published in: PloS one 2015-09, Vol.10 (9), p.e0138488-e0138488
• Main Authors: Shiferaw, Melashu Balew, Hailu, Hiwot Amare, Fola, Abebe Alemu, Derebe, Mulatu Melese, Kebede, Aimro Tadese, Kebede, Abayneh Admas, Emiru, Manamnot Agegne, Gelaw, Zelalem Dessie
• Format: Article
• Language: English
• Subjects: Acids; Acquired immune deficiency syndrome; AIDS; Bacteriological Techniques - standards; Clinical Laboratory Techniques - standards; Cross-Sectional Studies; Diagnosis; Diagnostic systems; Ethics; Ethiopia - epidemiology; Health care facilities; Health facilities; Humans; Laboratories; Laboratories - standards; Laboratory Proficiency Testing; Lot Quality Assurance Sampling; Medical diagnosis; Medical research; Microscopy; Multivariate analysis; Mycobacterium tuberculosis - isolation & purification; Nutrition research; Precision medicine; Public health; Quality assessment; Quality assurance; Quality Control; Smear; Solution strengthening; Sputum; Sputum - microbiology; Stains (Microscopy); Technical services; Technologists; Testing; Tuberculosis; Tuberculosis - diagnosis; Tuberculosis - epidemiology; Tuberculosis - microbiology
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0138488

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. 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. 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. 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.