Evaluation of external quality assessment results of 15 clinical laboratory quality indicators in China from 2019 to 2021.

Objectives

This study analyzed external quality assessment (EQA) results for 15 clinical laboratory quality indicators (QIs) in China from 2019 to 2021 to evaluate error-influencing factors, benchmark performance against international standards and inform preliminary quality specifications.

Methods

Data for 15 QIs were collected via a web-based EQA system from 2019 to 2021. Variations across years were analyzed using descriptive statistics and Kruskal Wallis H test.

Results

Participation rates exceeded 75% for most indicators. Specimen acceptability indicators improved significantly over time. Pre-examination and intra-laboratory turnaround times (TATs) for routine and stat samples remained generally stable over the study period, except for a slight but significant increase in intra-laboratory TAT for stat samples (p < 0.001). The median rate of tests covered by an EQA-proficiency testing (PT) control reached 100%, whereas the rates of tests covered by internal quality control (IQC) and inter-laboratory comparison required improvement. The median rate of unacceptable performances in EQA-PT schemes from 2019 to 2021 was 0%, while the 75th percentile reached nearly 4%. This finding reveals considerable performance variation among individual laboratories. Reporting-related indicators yielded satisfactory results. Most laboratories achieved 100% for timely critical value notification, despite statistically significant inter-annual variations (p < 0.05).

Conclusions

Overall laboratory quality improved from 2019 to 2021. Deficiencies in tests covered by IQC and inter-laboratory comparison require targeted improvements and sustained monitoring of quality indicators.