ABSTRACT
INTRODUCTION: Early warning and objective evidence of systematic errors in laboratory diagnosis ensures evidence based corrective and preventive actions that instill patient safety and confidence. External quality assessment contributes significantly to the above as an essential component of laboratory quality assurance. However, implementation of External Quality Assessment in resource-limited settings is challenged by high costs of enrolling in international schemes. To ensure sustainability, a National External Quality Assessment Program in Armenia was developed using a One Health approach. METHODS: Through engagement of stakeholders from Ministry of Health and Department of Agriculture under Ministry of Economy the government of Armenia started the implementation of the Armenia Laboratory External Quality Assessment (ALEQA) program. Policies and procedures were defined, a web interface for return of results and feedback reporting was created. A training was offered for characterization of simulated samples for bacterial pathogens. Following a pilot survey, the program was successfully scaled up, with later addition of a Brucella serology discipline. RESULTS: The return rate of results was 100% for all surveys. There was an improvement in the performance of the laboratories from the 2015 to the 2019 surveys. The bacterial pathogens EQA survey's, was interrupted between 2017 and 2019. The Brucella Serology survey showed 77% of the 26 participating laboratories had satisfactory performance. CONCLUSION: This is one of the few National EQA Programs that have embraced the One Health approach to improve reach of EQA Programs in resource-limited settings in both human and veterinary laboratories.
ABSTRACT
OBJECTIVE: To describe findings from an external quality assessment programme involving laboratories in Africa that routinely investigate epidemic-prone diseases. METHODS: Beginning in 2002, the Regional Office for Africa of the World Health Organization (WHO) invited national public health laboratories and related facilities in Africa to participate in the programme. Three surveys comprising specimens and questionnaires associated with bacterial enteric diseases, bacterial meningitis, plague, tuberculosis and malaria were sent annually to test participants' diagnostic proficiency. Identical surveys were sent to referee laboratories for quality control. Materials were prepared, packaged and shipped in accordance with standard protocols. Findings and reports were due within 30 days. Key methodological decisions and test results were categorized as acceptable or unacceptable on the basis of consensus feedback from referees, using established grading schemes. FINDINGS: Between 2002 and 2009, participation increased from 30 to 48 Member States of the WHO and from 39 to 78 laboratories. Each survey was returned by 64-93% of participants. Mean turnaround time was 25.9 days. For bacterial enteric diseases and meningitis components, bacterial identification was acceptable in 65% and 69% of challenges, respectively, but serotyping and antibiotic susceptibility testing and reporting were frequently unacceptable. Microscopy was acceptable for 73% of plague challenges. Tuberculosis microscopy was satisfactorily performed, with 87% of responses receiving acceptable scores. In the malaria component, 82% of responses received acceptable scores for species identification but only 51% of parasite quantitation scores were acceptable. CONCLUSION: The external quality assessment programme consistently identified certain functional deficiencies requiring strengthening that were present in African public health microbiology laboratories.
