Evaluation of the laboratory assessment process for A Clinically Oriented Antimicrobial Resistance Surveillance Network (ACORN-LAP) in low-income and middle-income countries: a multicountry, cross-sectional analysis with longitudinal quality monitoring.

BACKGROUND: High-quality microbiology laboratory data underpin effective antimicrobial resistance (AMR) surveillance. Laboratory assessments are useful for ensuring the quality of microbiology data used for AMR surveillance, especially in low-income and middle-income countries where accreditation might not be feasible. In this study, we aimed to evaluate the microbiology laboratory assessment and quality monitoring tools developed to assess laboratories participating in A Clinically Oriented Antimicrobial Resistance Surveillance Network 2 (ACORN2).

METHODS: We conducted a multicountry observational study of microbiology laboratories participating in the ACORN2 surveillance project, including a baseline cross-sectional laboratory assessment process (ACORN-LAP) with longitudinal quality monitoring and follow-up. Between Sept 21, 2021, to Nov 25, 2024, all laboratories of hospitals identified as ACORN2 sites identified through investigator networks were invited to complete the ACORN-LAP. These laboratories were from nine countries across Asia and Africa. The assessment included an online REDCap-based assessment, and document-based and video call-based reviews by two selected ACORN assessors. The laboratories participated in quarterly quality monitoring processes, including the review of internal quality control (IQC) and external quality assessment (EQA) results. Anonymous feedback was collected, and an in-person feedback session was conducted during the study. The primary evaluation outcome was the findings of the ACORN-LAP, including the number of key and non-key recommendations identified. Secondary evaluation outcomes included quality monitoring performance, laboratory feedback on the ACORN-LAP and quality monitoring processes, and comparison of the ACORN-LAP and quality monitoring processes with existing laboratory assessment tools.

FINDINGS: 20 laboratories completed the ACORN-LAP. The median time from initial contact with the laboratory to issuing recommendations was 3 months (IQR 3-4; range 1-8). The assessors identified 144 recommendations (median 6 per laboratory [IQR 3-8·5]; range 2-21), including 46 key and 98 non-key recommendations. Non-accredited laboratories received more recommendations per laboratory than accredited laboratories (median difference 5 [95% CI 1-11]; p=0·0062 and incidence rate ratio (IRR) 2·5 [95% CI 1·56-4·09]; p=0·0002). Non-accredited laboratories also received more key recommendations per laboratory (median difference 2 [95% CI 1-5]; p=0·0030) and IRR 4·75 [95% CI 2·11-11·84]; p=0·0003). 116 quality monitoring forms were completed (median 6 per laboratory [IQR 4-7]; range 2-9). 115 IQC and 59 scored EQA events were reported. Review of such quality monitoring data identified previously undetected IQC failures and led to improved IQC recording in some laboratories. Feedback showed that laboratories considered the assessment process useful although some laboratories found the assessment process labour intensive.

INTERPRETATION: The findings support the use of structured laboratory assessment with ongoing quality monitoring to strengthen AMR surveillance, particularly in non-accredited laboratories. A simple, harmonised global online tool with integrated quality monitoring that assesses against a minimum standard could improve the quality and comparability of AMR surveillance data in low-income and middle-income countries.

FUNDING: Wellcome Trust.