title: External quality assessment of AFB smear microscopy performances and its associated factors in selected private health facilities in Addis Ababa, Ethiopia.
abstract: Tuberculosis (TB) is still a public health problem in sub Saharan African countries. In resource-limited settings, TB diagnosis relies on sputum smear microscopy, with low and variable sensitivities, especially in paucibacillary pediatric and HIV-associated TB patients. Tuberculosis microscopy centers have several weaknesses like overworking, insufficiently trained personnel, inconsistent reagent supplies, and poorly maintained equipments; thus, there is a critical need for investments in laboratory infrastructure, capacity building, and quality assurance schemes. The performance of TB microscopy centers in the private health facilities in Addis Ababa is not known so far. The main objective of the study was to assess laboratory performance of acid fast bacilli (AFB) smear microscopy and its associated factors in selected private health facilities in Addis Ababa, Ethiopia. A cross-sectional study was conducted in 33 selected private health facilities of Addis Ababa, Ethiopia comprising 7 hospitals, 2 NGO health centers, 23 higher clinics and 1 diagnostic laboratory that provide AFB smear microscopy services. The study was conducted from January to April 2014. A total of 283 stained sputum smears were randomly collected from participant laboratories for blinded rechecking, 320 panel slides were sent to 32 microscopy centers to evaluate their performance on AFB reading, staining and reporting. Checklists were used to assess quality issues of laboratories. Data were captured, cleaned, and analyzed using SPSS version 16.0; χ(2) tests, kappa statistics were used for comparison purpose. P value < 0.05 considered statistically significant. Among the 32 participant laboratories, 2-scored 100%, 15 scored 80-95% & the remaining 15 scored 50-75% for overall proficiency test performance. There were 10 (3.15%) major errors and 121 (37.8%) minor errors. The sensitivity, specificity, PPV and NPV of panel reading by microscopy centers were 89%, 96%, 96%, and 90% respectively. Out of 283 randomly selected slides for blind rechecking, 11 (3.9%) slides interpreted falsely for AFB, with overall agreement of 97.5%, sensitivity of 88.4% and specificity of 99.3%. In terms of slide quality assessment, 71.6% of AFB slides were graded as good for evenness, cleanness, thickness, size, staining and labeling. The performance score for AFB slide evenness was 56.9% (161 slides) and for labeling quality was 90.8% (257 slides); having significant difference in slide quality (p value < 0.05). On-site evaluation indicated problems in terms of infrastructure, standard operating procedure, reagent quality; equipment maintenance, data management and training issues. Most of the health facilities had poor maintenance scheme for microscope (53.5%) and poor inventory management (25.0%) system. Microscopy centers that scored a proficiency of 75.5%; which is below the acceptable minimum score of 80% and an overall error rate of 3.9% for blinded rechecking needs attention. Moreover, there are gaps identified through on site assessment including poor SOP, reagent quality, equipment maintenance, data management & lack of updated training on AFB microscopy techniques, requiring a concerted effort to alleviate the bottle neck problems and strengthening the public private partnership to control TB.
authors.affiliation: Addis Abeba University, College of Health Sciences, School of Allied Health Sciences Department of Medical Laboratory Sciences, Addis Abeba, Ethiopia; City Government of Addis Ababa Technical & Vocational Education & Training (TVET) Agency, Addis Abeba, Ethiopia.
authors.forename: Lemi
authors.initials: L
authors.lastname: Mosissa
authors.affiliation: Ethiopian Public Health Institute (EPHI), Addis Abeba, Ethiopia.
authors.forename: Abebaw
authors.initials: A
authors.lastname: Kebede
authors.affiliation: Addis Abeba University, College of Health Sciences, School of Allied Health Sciences Department of Medical Laboratory Sciences, Addis Abeba, Ethiopia.
authors.forename: Tedla
authors.initials: T
authors.lastname: Mindaye
authors.affiliation: Ethiopian Public Health Institute (EPHI), Addis Abeba, Ethiopia.
authors.forename: Muluwork
authors.initials: M
authors.lastname: Getahun
authors.affiliation: Minilik II Referral Hospital, Addis Abeba, Ethiopia.
authors.forename: Sisay
authors.initials: S
authors.lastname: Tulu
authors.affiliation: Addis Abeba University, College of Health Sciences, School of Allied Health Sciences Department of Medical Laboratory Sciences, Addis Abeba, Ethiopia.
authors.forename: Kassu
authors.initials: K
authors.lastname: Desta
mesh_terms: D001431:Bacteriological Techniques / Q000379:methods; D003430:Cross-Sectional Studies; D005002:Ethiopia; D006801:Humans; D007753:Laboratories / Q000592:standards*; D008853:Microscopy / Q000592:standards*; D011237:Predictive Value of Tests; D000072263:Private Facilities; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology; D014376:Tuberculosis / Q000175:diagnosis*
keywords: EQA; blinded rechecking; major error; minor error; onsite evaluation; panel testing