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Development and Implementation of an Internal Quality Control and External Quality Assessment Information System for
Dayang Chen1,2, Hongmei Mo1,2, Yingying Zhang3
1Department of Medical Laboratory, The Third Affiliated Hospital of Shenzhen University, Shenzhen, China.
JMIR Formative Research
|December 9, 2025
Summary
This study developed an integrated informatics platform, iLab, to standardize internal quality control (IQC) and external quality assessment (EQA) in Regional Medical Laboratory Centers (RMLCs). The system significantly improved QC implementation rates and reduced error rates, enhancing overall laboratory quality.
Area of Science:
- Medical Laboratory Science
- Health Informatics
- Quality Management Systems
Background:
- Regional Medical Laboratory Centers (RMLCs) integrate diverse hospital labs to optimize resources and expertise.
- Ensuring consistent quality control (QC) across RMLCs is challenging due to varied equipment, procedures, and staff expertise.
- An informatics tool, iLab, was developed to manage internal quality control (IQC) and external quality assessment (EQA).
Purpose of the Study:
- To develop and implement an integrated informatics platform for managing IQC and EQA across RMLCs.
- To standardize and enhance laboratory quality management within a regional network.
Main Methods:
- Integrated four software programs: LIS, QCBOX, QCEC, and iLab electronic recording system.
- Centralized QC data processing, with QCBOX/QCEC for workflows and iLab for documentation and analytics.
- Successfully deployed in a pilot network of hospitals and community health stations in Shenzhen's Luohu District.
Main Results:
- Streamlined IQC and EQA processes, including interlaboratory comparisons and electronic documentation.
- Significant improvements observed: IQC implementation rate increased to 99.87%, report error rate decreased to 0.027%.
- Annual EQA unacceptable rate dropped to 0%, and ISO 15189-accredited test items increased.
Conclusions:
- The iLab system provides a scalable framework for standardized IQC and EQA management in RMLCs.
- Demonstrated significant potential to enhance regional laboratory quality and compliance.
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