title: Decentralization of Acid Fast Bacilli (AFB) External Quality Assurance Using Blind Rechecking for Sputum Smear Microscopy in Ethiopia.
abstract: BACKGROUND
  Ethiopia achieved a rapid expansion of TB microscopic centers for acid fast bacilli (AFB). However, external quality assurance (EQA) services were, until recently, limited to few regional and sub-regional laboratories. In this paper, we describe the decentralization experience and the result of EQA using random blinded rechecking.
  
  
  METHODS
  The routine EQA quarterly report was compiled and analyzed. A positive result by the microscopic center while the EQA center reported negative result is categorized as false positive (FP). A negative result by the microscopic center while the EQA center reported positive is considered false negative (FN). The reading of EQA centers was considered a gold standard to compute the sensitivity, specificity, positive predictive (PPV) and negative predictive values (NPV) of the readings of microscopic centers.
  
  
  RESULTS
  We decentralized sputum smear AFB EQA from 4 Regional Laboratories (RRLs) to 82 EQA centers and enrolled 956 health facilities in EQA schemes. Enrollment of HFs in EQA was gradual because it required training and mentoring laboratory professionals, institutionalizing internal QA measures, equipping all HFs to perform diagnosis, and establishing more EQA centers. From 2012 to 2014 (Phase I), the FP rate declined from 0.6% to 0.2% and FN fell from as high as 7.6% to 1.6% in supported health facilities (HFs). In HFs that joined in Phase II, FN rates ranged from 5.6 to 7.3%. The proportion of HFs without errors has increased from 77.9% to 90.5% in Phase I HFs and from 82.9% to 86.9% in Phase II HFs. Overall sensitivity and specificity were 95.0% and 99.7%, respectively. PPV and NPV were 93.3% and 99.7%, respectively.
  
  
  CONCLUSIONS
  Decentralizing blinded rechecking of sputum smear microscopy is feasible in low-income settings. While a comprehensive laboratory improvement strategy enhanced the quality of microscopy, laboratory professionals' capacity in slide reading and smear quality requires continued support.
authors.affiliation: Management Sciences for Health, Help Ethiopia Address the Low Performance of Tuberculosis (HEAL TB) Project, Addis Ababa, Ethiopia.
authors.forename: Muluken
authors.initials: M
authors.lastname: Melese
authors.affiliation: Management Sciences for Health, Help Ethiopia Address the Low Performance of Tuberculosis (HEAL TB) Project, Addis Ababa, Ethiopia.
authors.forename: Degu
authors.initials: D
authors.lastname: Jerene
authors.affiliation: Amhara Regional Health Bureau, Bahir Dar, Ethiopia.
authors.forename: Genetu
authors.initials: G
authors.lastname: Alem
authors.affiliation: Management Sciences for Health, Help Ethiopia Address the Low Performance of Tuberculosis (HEAL TB) Project, Addis Ababa, Ethiopia.
authors.forename: Jemal
authors.initials: J
authors.lastname: Seid
authors.affiliation: Oromia Regional Reference Laboratory, Addis Ababa, Ethiopia.
authors.forename: Feleke
authors.initials: F
authors.lastname: Belachew
authors.affiliation: Management Sciences for Health, Help Ethiopia Address the Low Performance of Tuberculosis (HEAL TB) Project, Addis Ababa, Ethiopia.
authors.forename: Yewulsew
authors.initials: Y
authors.lastname: Kassie
authors.affiliation: Management Sciences for Health, Help Ethiopia Address the Low Performance of Tuberculosis (HEAL TB) Project, Addis Ababa, Ethiopia.
authors.forename: Dereje
authors.initials: D
authors.lastname: Habte
authors.affiliation: Management Sciences for Health, Help Ethiopia Address the Low Performance of Tuberculosis (HEAL TB) Project, Addis Ababa, Ethiopia.
authors.forename: Solomon
authors.initials: S
authors.lastname: Negash
authors.affiliation: Ethiopian Public Health Institute, Addis Ababa, Ethiopia.
authors.forename: Gonfa
authors.initials: G
authors.lastname: Ayana
authors.affiliation: Management Sciences for Health, Help Ethiopia Address the Low Performance of Tuberculosis (HEAL TB) Project, Addis Ababa, Ethiopia.
authors.forename: Belaineh
authors.initials: B
authors.lastname: Girma
authors.affiliation: United States Agency for International Development (USAID), Addis Ababa, Ethiopia.
authors.forename: Yared K
authors.initials: YK
authors.lastname: Haile
authors.affiliation: Management Sciences for Health, Help Ethiopia Address the Low Performance of Tuberculosis (HEAL TB) Project, Addis Ababa, Ethiopia.
authors.forename: Nebiyu
authors.initials: N
authors.lastname: Hiruy
authors.affiliation: Management Sciences for Health, Center for Health Services, Arlington, Virginia, United States of America.
authors.forename: Pedro G
authors.initials: PG
authors.lastname: Suarez
mesh_terms: D001431:Bacteriological Techniques / Q000592:standards; D005002:Ethiopia; D005188:False Negative Reactions; D005189:False Positive Reactions; D006801:Humans; D007753:Laboratories / Q000458:organization & administration* / Q000592:standards; D008853:Microscopy / Q000379:methods* / Q000592:standards; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification* / Q000472:pathogenicity; D011786:Quality Control; D013183:Sputum / Q000382:microbiology*; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000382:microbiology