Development and application of management functions for internal quality control data of qualitative and semi-quantitative i-tems in laboratory information system
10.13602/j.cnki.jcls.2025.02.09
- VernacularTitle:实验室信息系统定性及半定量项目室内质控数据管理功能的开发和应用
- Author:
Li WANG
1
;
Lu LIU
1
;
Zhenxi YANG
1
;
Wei CUII
1
Author Information
1. 国家癌症中心国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院检验科,北京 100021
- Publication Type:Journal Article
- Keywords:
qualitative and semi-quantitative items;
internal quality control;
data management;
laboratory information system
- From:
Chinese Journal of Clinical Laboratory Science
2025;43(2):120-125
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the application of the Laboratory Information System(LIS)in managing internal quality control(IQC)data of qualitative and semi-quantitative items in each professional group of the laboratories,providing front-end operation and back-end data support to achieve real-time effectiveness,easy operation,perfect functionality,and compliance with the quality control data management in various inspection standards.Methods Referring to the requirements for internal quality control(IQC)data man-agement of qualitative and semi-quantitative items in the health industry standard WS/T 806-2022"Basic technical standard for clini-cal hematology and body fluid analysis"and CNAS-CL02:2023"Accreditation criteria for the quality and competence of medical labora-tories",we developed the functions of IQC data management for qualitative and semi-quantitative items in LIS using PowerBuilder 12.5 development tools and tried to applied these functions in our laboratory.Results The management module for IQC data of qualitative and semi-quantitative items developed in LIS consisted of three parts:"IQC Parameter Setting","IQC and Comparison Data",and"IQC Monthly Summary".In accordance with the routine laboratory operation process,the developed management modules implemented the following functions,such as IQC parameters setting,IQC data in-control ranges setting,automatic judgment of out-of-control data,online filling of out-of-control reports,IQC monthly summary reports template setting,and generating IQC monthly summary reports.The developed module has been applied to qualitative and semi-quantitative items in various professional groups of clinical laboratories in multiple districts of the hospital,such as urinalysis for dry chemical parameters,blood type testing,fecal occult blood test,etc.The module has operated stably and achieves homogeneous management of IQC for multiple districts and multiple test items.Conclusion The developed IQC data management function for qualitative and semi-quantitative items in LIS exhibited a user-friendly interface and performance of easy operation.The generated quality control charts and monthly summary reports have been completed in content and complied with industry standards and ISO 15189 accreditation requirements.It can well meet the management needs of various profes-sional groups for IQC of qualitative and semi-quantitative items in the daily work of medical laboratories setting a good foundation for continuous improvement of intelligent management of clinical laboratory information.The design ideas and application models presented certain reference value.