Decentralization of Acid Fast Bacilli (AFB) External Quality Assurance Using Blind Rechecking for Sputum Smear Microscopy in Ethiopia

PLoS One. 2016 Mar 18;11(3):e0151366. doi: 10.1371/journal.pone.0151366. eCollection 2016.

Abstract

Introduction: 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.

Materials and 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.

Conclusion: 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.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Bacteriological Techniques* / standards
  • Ethiopia
  • False Negative Reactions
  • False Positive Reactions
  • Humans
  • Laboratories / organization & administration*
  • Laboratories / standards
  • Microscopy / methods*
  • Microscopy / standards
  • Mycobacterium tuberculosis / isolation & purification*
  • Mycobacterium tuberculosis / pathogenicity
  • Quality Control*
  • Sputum / microbiology*
  • Tuberculosis, Pulmonary / diagnosis*
  • Tuberculosis, Pulmonary / microbiology

Grants and funding

United States Agency for International Development(USAID) supported this work through HEAL TB, under cooperative agreement number AID-663-A-11-00011. The contents of the article are the responsibility of the authors alone and do not necessarily reflect the views of USAID or the US government.