The surveys on quality indicators for the total testing process in clinical laboratories of Fujian Province in China from 2018 to 2023
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Yao Li
Abstract
Objectives
This study investigates the application of 15 Quality Indicators (QIs) in clinical laboratories in Fujian Province, China, from 2018 to 2023. It identifies the main causes of laboratory errors and explores issues in the application of QIs, providing a reference for establishing provincial state-of-the-art and operational quality specifications (QSs).
Methods
All clinical laboratories in Fujian Province were organized to submit general information and original QIs data through the online External Quality Assessment (EQA) system of the National Clinical Laboratory Center (NCCL) for a survey of 15 QIs. Data from 2018 to 2023 were downloaded for statistical analysis, and the current QSs for the 15 QIs in Fujian Province were compared and analyzed with those published by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Laboratory Errors and Patient Safety (WG-LEPS).
Results
QIs data from 542 clinical laboratories were collected. The survey on data sources showed that the number of laboratories recording QIs data using Laboratory Information Systems (LIS) increased annually, but the growth was modest and the proportion was less than 50 %. Among the laboratories using LIS to record QIs data, 133 continuously participated in this survey for six years, reporting different QIs. Over the six years, all reported QIs showed significant improvement or at least remained stable. The best median Sigma (σ) metrics were for the percentage of critical values notification and timely critical values notification, reaching 6σ, followed by the percentage of incorrect laboratory reports, with σ metrics ranging from 4.9σ to 5.1σ. In contrast, the percentage of tests covered by internal quality control (IQC) (1.5σ–1.7σ) and inter-laboratory comparison (0.1σ) remained consistently low. Compared to the QSs published by IFCC WG-LEPS, the QSs for the 15 QIs in Fujian Province in 2023 were stricter or roughly equivalent, except for the percentage of incorrect laboratory reports (Fujian Province: 0–0.221, IFCC WG-LEPS: 0–0.03).
Conclusions
1. The application of QIs has significantly improved the quality of testing in clinical laboratories in Fujian Province, but the percentage of tests covered by IQC and inter-laboratory comparison remain low; 2. Effective application of QIs requires the establishment of comprehensive LIS, unified calculation standards, and other supporting measures.
Funding source: Joint funds for the innovation of science and technology in Fujian Province
Award Identifier / Grant number: 2023Y9353
Acknowledgments
We appreciate those participant laboratories and institutions that attended the Fujian provincial QIs survey. We also thank the contribution of National Center for Clinical Laboratories (NCCL) made in external quality assessment (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: The authors have accepted responsibility for the entire content of this manuscript and approved submission.
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Competing interests: The authors state no conflict of interest.
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Research funding: Joint funds for the innovation of science and technology in Fujian Province were involved in this study. Grant Number: Fujian province 2023Y9353.
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Data availability: The raw data can be obtained on request from the corresponding author.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0495).
© 2024 Walter de Gruyter GmbH, Berlin/Boston
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Blood self-sampling: friend or foe?
- Reviews
- Blood self-sampling devices: innovation, interpretation and implementation in total lab automation
- Salivary fatty acids in humans: a comprehensive literature review
- Opinion Papers
- EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) recommendations for reinforcing cyber-security and managing cyber-attacks in medical laboratories
- Point-of-care testing: state-of-the art and perspectives
- A standard to report biological variation data studies – based on an expert opinion
- Ethical Checklists for Clinical Research Projects and Laboratory Medicine: two tools to evaluate compliance with bioethical principles in different settings
- Guidelines and Recommendations
- Assessment of cardiovascular risk and physical activity: the role of cardiac-specific biomarkers in the general population and athletes
- Genetics and Molecular Diagnostics
- Clinical utility of regions of homozygosity (ROH) identified in exome sequencing: when to pursue confirmatory uniparental disomy testing for imprinting disorders?
- An ultrasensitive DNA-enhanced amplification method for detecting cfDNA drug-resistant mutations in non-small cell lung cancer with selective FEN-assisted degradation of dominant somatic fragments
- General Clinical Chemistry and Laboratory Medicine
- The biological variation of insulin resistance markers: data from the European Biological Variation Study (EuBIVAS)
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- Performance evaluation of a smartphone-based home test for fecal calprotection
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- Development and validation of a novel 7α-hydroxy-4-cholesten-3-one (C4) liquid chromatography tandem mass spectrometry method and its utility to assess pre-analytical stability
- Establishment of ELISA-comparable moderate and high thresholds for anticardiolipin and anti-β2 glycoprotein I chemiluminescent immunoassays according to the 2023 ACR/EULAR APS classification criteria and evaluation of their diagnostic performance
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- Cardiovascular Diseases
- The role of functional vitamin D deficiency and low vitamin D reservoirs in relation to cardiovascular health and mortality
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- Reviewer Acknowledgment
- Letters to the Editor
- EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) survey on cybersecurity
- Comment on Lippi et al.: EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) recommendations for reinforcing cyber-security and managing cyber-attacks in medical laboratories
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- New generation of Abbott enzyme assays: imprecision, methods comparison, and impact on patients’ results
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