Abstract
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. 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. 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. 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.
Highlights
A one of the step towards achieving TB related targets is to ensure early and quality diagnosis of TB in national laboratories
The Sustainable Development Goals (SDGs), adopted in September 2015, and the World Health Organization (WHO) End TB Strategy, have a common goal with respect to TB to end the Global TB Epidemic [1,2] An integral component is the 90-(90)-90 TB diagnostic and treatment targets [3,4] diagnose and treat at least 90% of all people with TB; diagnose and treat at least (90%) of the key populations with TB; achieve at least 90% treatment success for all people diagnosed with TB [4]
Since 2016, Armenia has been making efforts towards improving the quality of its national TB reference laboratory (TB NRL). This was done through introduction of the TB Strengthening Laboratory Quality Management Toward Accreditation (TB SLMTA) [7]
Summary
The Sustainable Development Goals (SDGs), adopted in September 2015, and the World Health Organization (WHO) End TB (tuberculosis) Strategy, have a common goal with respect to TB to end the Global TB Epidemic [1,2] An integral component is the 90-(90)-90 TB diagnostic and treatment targets [3,4] diagnose and treat at least 90% of all people with TB; diagnose and treat at least (90%) of the key populations with TB; achieve at least 90% treatment success for all people diagnosed with TB [4]. A first step towards achieving these TB related targets is to ensure early and quality diagnosis of TB in national laboratories [5]. This would foster rational TB treatments and build confidence of health workers, and the community in the TB control program. Since 2016, Armenia has been making efforts towards improving the quality of its national TB reference laboratory (TB NRL) This was done through introduction of the TB Strengthening Laboratory Quality Management Toward Accreditation (TB SLMTA) [7]. In the TB NRL of Armenia, we assessed the evolution of a) the QMS score (points) in relation to TB SLMTA targets and b) sputum specimen rejection rates and specific quality indicators for culture
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