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      Evaluating Quality Management and Diagnostics Microbiology Performance Within an International External Quality Assessment (EQA) Program Serving National One Health Sector Reference Laboratories Across Asia: Experience Amid the Coronavirus Disease 2019 (COVID-19) Pandemic

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          Abstract

          Background

          Strengthening external quality assessment (EQA) services across the One Health sector supports implementation of effective antimicrobial resistance (AMR) control strategies. Here we describe and compare 2 different approaches for conducting virtual laboratory follow-up assessments within an EQA program to evaluate quality management system (QMS) and procedures for pathogen identification and antimicrobial susceptibility testing (AST).

          Methods

          During the coronavirus disease 2019 (COVID-19) pandemic in 2021 and 2022, 2 laboratory assessment approaches were introduced: virtual-based and survey-based methodologies. The evaluation of 2 underperforming Animal Health laboratories through a virtual-based approach occurred between May and August 2021. This evaluation encompassed the utilization of 3 online meetings and document reviews, performed subsequent to the execution of EQA procedures. Within a distinct group of laboratories, the survey-based assessment was implemented from December 2021 to February 2022, also following EQA procedures. This phase encompassed the dissemination of an online survey to 31 participating laboratories, alongside a sole online consultation meeting involving 4 specific underperforming laboratories.

          Results

          The virtual-based assessment post-EQA aimed to identify gaps and areas for improvement in the laboratory's practices for pathogen identification and AST. This approach was, however, time-intensive, and, hence, only 2 laboratories were assessed. In addition, limited interactions in virtual platforms compromised the assessment quality. The survey-based post-EQA assessment enabled evaluation of 31 laboratories. Despite limitations for in-depth analysis of each procedure, gaps in QMS across multiple laboratories were identified and tailored laboratory-specific recommendations were provided.

          Conclusions

          Reliable internet and plans for efficient time management, post-EQA virtual laboratory follow-up assessments are an effective alternative when conducting onsite evaluation is infeasible as observed during the COVID-19 pandemic, although the successful implementation of remediation plans will likely require in person assessments. We advocate application of hybrid approaches (both onsite and virtual) for targeted capacity building of AMR procedures with the ability to implement and oversee the process.

          Abstract

          External quality assessment (EQA) is crucial for quality assurance in antimicrobial resistance (AMR) surveillance and effective control interventions. Optimized capacity-building approaches are needed post-EQA for different scenarios, including pandemics with travel restrictions.

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          Most cited references12

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          External quality assessment of national public health laboratories in Africa, 2002-2009

          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.
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            Implementation of quality management for clinical bacteriology in low-resource settings.

            The declining trend of malaria and the recent prioritization of containment of antimicrobial resistance have created a momentum to implement clinical bacteriology in low-resource settings (LRS). Successful implementation relies on guidance by a quality management system (QMS). Over the past decade, international initiatives were launched towards implementation of QMS in HIV/AIDS, tuberculosis and malaria.
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              Global antimicrobial resistance and use surveillance system (GLASS) report: 2021

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                Author and article information

                Contributors
                Journal
                Clin Infect Dis
                Clin Infect Dis
                cid
                Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
                Oxford University Press (US )
                1058-4838
                1537-6591
                15 December 2023
                20 December 2023
                20 December 2023
                : 77
                : Suppl 7 , Capturing Data on Antimicrobial Resistance Patterns and Trends in Use in Regions of Asia (CAPTURA)
                : S588-S596
                Affiliations
                International Vaccine Institute , Seoul, Republic of Korea
                The Technical University of Denmark , National Food Institute, WHO Collaborating Center for Antimicrobial Resistance in Foodborne Pathogens and Genomics and European Union Reference Laboratory for Antimicrobial Resistance, FAO Reference Laboratory for Antimicrobial Resistance, Kgs. Lyngby, Denmark
                International Vaccine Institute , Seoul, Republic of Korea
                International Vaccine Institute , Seoul, Republic of Korea
                International Vaccine Institute , Seoul, Republic of Korea
                International Vaccine Institute , Seoul, Republic of Korea
                International Vaccine Institute , Seoul, Republic of Korea
                The Technical University of Denmark , National Food Institute, WHO Collaborating Center for Antimicrobial Resistance in Foodborne Pathogens and Genomics and European Union Reference Laboratory for Antimicrobial Resistance, FAO Reference Laboratory for Antimicrobial Resistance, Kgs. Lyngby, Denmark
                Research Unit for Microbial Food Safety and Antimicrobial Resistance , Faculty of Veterinary Science, Chulalongkorn University, Bangkok, Thailand
                Research Unit for Microbial Food Safety and Antimicrobial Resistance , Faculty of Veterinary Science, Chulalongkorn University, Bangkok, Thailand
                National Institute of Health , Bangkok, Thailand
                Research Unit for Microbial Food Safety and Antimicrobial Resistance , Faculty of Veterinary Science, Chulalongkorn University, Bangkok, Thailand
                International Vaccine Institute , Seoul, Republic of Korea
                Cambridge Institute of Therapeutic Immunology and Infectious Disease , University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom
                Heidelberg Institute of Global Health , University of Heidelberg, Heidelberg, Germany
                Madagascar Institute for Vaccine Research , University of Antananarivo, Antananarivo, Madagascar
                The Technical University of Denmark , National Food Institute, WHO Collaborating Center for Antimicrobial Resistance in Foodborne Pathogens and Genomics and European Union Reference Laboratory for Antimicrobial Resistance, FAO Reference Laboratory for Antimicrobial Resistance, Kgs. Lyngby, Denmark
                International Vaccine Institute , Seoul, Republic of Korea
                Author notes
                Correspondence: F. A. Abegaz, International Vaccine Institute, SNU Research Park, 1 Gwanak-ro, Gwanak-gu, Seoul 08826, Republic of Korea ( Freshwork.abegaz@ 123456ivi.int ).

                Potential conflicts of interest. The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.

                Article
                ciad569
                10.1093/cid/ciad569
                10732555
                38118017
                47220e84-957f-488e-a969-9d01d110267b
                © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Page count
                Pages: 9
                Funding
                Funded by: Fleming Fund Regional Grant;
                Award ID: FF64-474
                Categories
                Supplement Article
                AcademicSubjects/MED00290

                Infectious disease & Microbiology
                external quality assessment,remote assessment,antimicrobial resistance,one health,quality management system

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