Performance of a quality control center supporting national antimicrobial resistance surveillance.

Abstract

Introduction: Ensuring the reliability, standardization, and international comparability of antimicrobial resistance (AMR) surveillance data critically depends on the implementation of robust quality assurance frameworks. South Korea established the Korea Global Antimicrobial Resistance Surveillance System (Kor-GLASS), supported by a centralized quality control center (QCC). As Kor-GLASS transitioned from Phase II to Phase III, new bacterial species and antimicrobial agents were incorporated, underscoring the need to evaluate whether quality assurance performance could be sustained during system expansion.

Materials and methods: We analyzed interlaboratory proficiency testing (IPT) and external quality assessment (EQA) outcomes generated by the QCC between 2020 and 2024, covering Phases II and III of Kor-GLASS. Clinical isolates were collected at participating hospitals and transferred to organism-specialized analysis centers for standardized antimicrobial susceptibility testing (AST), while the QCC independently oversees data quality through IPT and EQA. IPT was conducted by comparing AST results between analysis centers and the QCC using subsets of routine clinical isolates, with acceptance criteria defined as categorical agreement (CA) ≥90% and major error rates <3%. EQA involved quarterly distribution of pre-characterized strains to participating centers. Additional evaluations addressed the performance of newly introduced ceftazidime-avibactam susceptibility testing and interlaboratory validation for Haemophilus spp.

Results: Across the study period, overall CA consistently exceeded 97% in IPT, and no EQA failures observed among participating centers. While major errors during Phase II were primarily attributable to AST reading and near-breakpoint discrepancies, their frequency markedly decreased in Phase III following targeted corrective actions and educational interventions. Susceptibility testing for ceftazidime-avibactam showed high concordance between centers, with rare discrepancies limited to near-breakpoint measurements. Interlaboratory validation confirmed acceptable performance for AST of Haemophilus spp., supporting its formal inclusion in Phase III.

Discussion: These findings demonstrate that a centralized, QCC-led quality assurance framework can maintain stable and reliable AMR surveillance performance during periods of system expansion. Beyond routine oversight, coordinated quality assurance activities function as an evidence-based evaluation of how standardized laboratory data are generated and validated, reinforcing their essential role in sustaining the credibility and future development of AMR surveillance systems.