Accepted for/Published in: JMIR Formative Research
Date Submitted: May 6, 2025
Date Accepted: Nov 20, 2025
Development and Implementation of an Internal Quality Control and External Quality Assessment Information System for a Regional Medical Laboratory Center: Pilot Study
ABSTRACT
Background:
Background:
The Regional Medical Laboratory Center (RMLC) integrates laboratory departments from hospitals with different levels to optimize resource allocation, enhance testing efficiency, and promote the sharing of professional expertise. Despite these benefits, ensuring consistent quality control (QC) across the RMLC presents a significant challenge due to diverse equipment, procedures, and staff expertise levels. To address these challenges, this study provided an information tool called iLab for managing Internal Quality Control (IQC) and External Quality Assessment (EQA).
Objective:
Objective:
This study aims to develop and implement an integrated informatics platform for standardized quality control management within the RMLC. Through this platform, we hope to achieve the unification and standardization of the IQC and EQA workflow in multi-layer laboratories, and better implement laboratory quality management.
Methods:
Methods:
We integrated four software programs: LIS, Quality Control Box (QCBOX), Quality Control EQA Center (QCEC) and iLab electronic recording system (iLab) to manage IQC and EQA. The platform centralizes QC data processing, with QCBOX and QCEC handling operational workflows, while iLab manages documentation, analytics, and approval processes.
Results:
Results:
The QC system was successfully deployed in August 2023 across five district-run hospitals, one central laboratory, and four community health stations in Luohu District, Shenzhen. As of September 2024, the system had 114 registered users, 133 QC instruments, and 895 active QC items. The system generated 1,900 total QC reports, including 12 IQC failure reports, 1,323 monthly IQC analysis reports, 262 EQA multi-rules analysis reports, 8 EQA failure analysis reports, and 295 measurement uncertainty calculation reports.
Conclusions:
Conclusion: The iLab system establishes a scalable framework for standardized IQC/EQA management in RMLC, demonstrating significant potential to enhance regional laboratory quality. Its success in achieving ISO 15189:2022 accreditation for 206 tests underscores its value as a model for integrated QC informatics. Clinical Trial: Not applicable.
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