Abstract
Objectives
The identification of reliable quality indicators (QIs) in the total testing process (TTP) is a pivotal step in quantifying laboratory service quality. This study comprehensively evaluated the performance quality and explored the factors affecting laboratory quality in Guangdong Province, China, by analyzing the results of QIs.
Methods
The Guangdong Clinical Laboratory Center organized an external quality assessment program for QIs, and the Clinet-EQA system was used to distribute questionnaires and collect data. The results of the QIs are expressed as percentages, sigma, or minutes. The optimum, desirable, and minimum quality specifications (QSs) were defined based on the percentiles of the QIs. Furthermore, the QIs were evaluated in different disciplines and hospital grades.
Results
A total of 335 laboratories in Guangdong Province reported complete data from 2020 to 2023, and QI performance progressively improved over the years. The performance of 11 QIs attained the minimum acceptable standard (sigma value ≥3), and most QIs across the diverse disciplines and hospital grades exhibited statistically significant differences. Compared to the QSs published by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Laboratory Errors and Patient Safety (WG-LEPS), the QSs for the 15 QIs in Guangdong Province in 2023 were stricter or roughly equivalent, except for the percentage of intra-laboratory turnaround time for emergency potassium tests.
Conclusions
From 2020 to 2023, the QIs in the post-analytical phase achieved the best performance. It is essential for laboratories to reinforce the construction of their information infrastructure, thereby guaranteeing the accurate collection of reliable data and enabling effective long-term monitoring.
Acknowledgments
We appreciate those participant laboratories which participate in Guangdong provincial QIs-EQA program. We also thank the contribution of National Center for Clinical Laboratories (NCCL) made in EQA system for data collection.
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Research ethics: Not applicable.
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Informed consent: Not applicable.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Use of Large Language Models, AI and Machine Learning Tools: None declared.
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Conflict of interest: The authors state no conflict of interest.
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Research funding: None declared.
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Data availability: Not applicable.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2024-1457).
© 2025 Walter de Gruyter GmbH, Berlin/Boston
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