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  

Development and application of management functions for internal quality control data of qualitative and semi-quantitative items in laboratory information system

作　　者：王力 刘璐 阳振曦 崔巍 WANG Li;LIU Lu;YANG Zhenxi;CUI Wei(Department of Clinical Laboratory,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China)

机构地区：[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

出　　处：《临床检验杂志》2025年第2期120-125,共6页Chinese Journal of Clinical Laboratory Science

摘　　要：目的探讨实验室信息系统在管理实验室各专业组定性及半定量项目室内质量控制数据方面的应用,提供前台操作和后台数据支持,实现实时有效、操作便捷、功能完善且符合各项检查标准的质控数据管理。方法参照WS/T806一2022《临床血液与体液检验基本技术标准》和CNAS-CL02:2023《医学实验室质量和能力认可准则》对定性及半定量项目室内质量控制数据管理的要求,利用PowerBuilder12.5开发工具,在实验室信息系统中开发定性及半定量项目室内质控数据的管理功能并进行应用。结果开发后的实验室信息系统定性及半定量项目室内质控数据管理模块包括“质控参数设置”、“质控及比对数据”和“质控月总结”三大部分。按照实验室常规操作流程,实现了质控参数设置、质控数据在控范围设置、失控数据自动判断、失控报告在线填写、质控月总结模板设置和质控月总结报告生成等功能。该模块已应用于医院多个院区实验室各专业组的定性及半定量项目,如尿液干化学分析、血型检测、粪便潜血试验等,运行稳定,实现了多院区、多检验项目的室内质控同质化管理。结论实验室信息系统中开发的定性及半定量项目室内质控数据管理功能,界面友好、操作便捷,绘制的质控图及月总结报告内容完整,符合行业标准及ISO15189认可要求,能够很好地满足医学实验室日常工作中各专业组对定性及半定量项目室内质量控制的管理需求,为实验室信息智能管理的持续改进奠定了良好基础,设计思路和应用模式具有一定的借鉴价值。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 management of qualitative and semi-quantitative items in the health industry standard WS/T 806-2022"Basic technical standard for clinical hematology and body fluid analysis"and CNAS-CL02:2023"Accreditation criteria for the quality and competence of medical laboratories",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 flling 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

关 键 词：定性及半定量项目 室内质量控制 数据管理 实验室信息系统 

分 类 号：R446[医药卫生—诊断学]