Mind the gap: Improving the performance of the reference laboratory to end-tuberculosis in Armenia

  • Viktorya Cholakyans National Tuberculosis Control Center of Ministry of Health of Armenia, Abovyan, Armenia
  • Eduard Kabasakalyan National Tuberculosis Control Center of Ministry of Health of Armenia, Abovyan, Armenia
  • Olga Denisiuk Alliance for Public Health, Kiev, Ukraine
  • Kristina Akopyan Gerald and Patricia Turpanjian School of Public Health, American University of Armenia, Yerevan, Armenia
  • Karapet Davtyan Tuberculosis Research and Prevention Center NGO, Yerevan, Armenia
  • Maka Akhalaia Program Sciences and Technical Support, Global Health Population and Nutrition, Bishkek, Kyrgyzstan
  • Alvard Mirzoyan National Tuberculosis Control Center of Ministry of Health of Armenia, Abovyan, Armenia
  • Armen Hayrapetyan National Tuberculosis Control Center of Ministry of Health of Armenia, Abovyan, Armenia
  • Rony Zachariah World Health Organization (WHO/TDR), Geneva, Switzerland
Keywords: QMS, Tuberculosis, NRL, Laboratory, GLP, SORT IT

Abstract

Introduction: A one of the step towards achieving TB related targets is to ensure early and quality diagnosis of TB in national laboratories. WHO recommends that all national reference laboratories in TB burden countries strive to reach accreditation by 2025, based on ISO15189:2012 quality management system standard. To identify gaps, progress and evaluated the evolution in implementation QMS we performed a formal assessment of the national TB reference laboratory of Armenia, as well as estimates the specific quality indicators of NRL activity.

Methodology: This is retrospective study cross-sectional study using laboratory data from the National TB Reference Laboratory in Armenia. Quality Management System assessments was conducted twice a year, using TB SLMTA assessment checklist. The sputum rejection and culture rates for quality indicators are calculated and assessed monthly.

Results: Compared to the baseline in 2016, there was a quality improvement reflecting the progress from zero to a “one star” in 2018. Areas that reached half of the target score included document and records, management review and responsibilities, evaluation and audits. Sections as “client management and customer service” and “evaluation and audits” stagnated in terms of progress. In terms of NRL performace, all indicators improved except for culture positivity in smear negative tuberculosis.

Conclusion: Although a quality management system was introduced in the NRL there is now an urgent need to develop and implement an adapted roadmap for Armenia. This will be vital to hasten the much-needed pace towards accreditation.

Published
2019-05-16
How to Cite
1.
Cholakyans V, Kabasakalyan E, Denisiuk O, Akopyan K, Davtyan K, Akhalaia M, Mirzoyan A, Hayrapetyan A, Zachariah R (2019) Mind the gap: Improving the performance of the reference laboratory to end-tuberculosis in Armenia. J Infect Dev Ctries 13:010S-015S. doi: 10.3855/jidc.10935
Section
The Armenian SORT IT Course