[1]刘佳丽,王 薇,陈兵权,等.临床检验定量测定项目统计质量控制程序设计软件的开发与应用[J].现代检验医学杂志,2025,40(05):194-199.[doi:10.3969/j.issn.1671-7414.2025.05.037]
　LIU Jiali,WANG Wei,CHEN Bingquan,et al.Development and Application of the Statistical Quality Control Program Design Software for Clinical Quantitative Measurement Items[J].Journal of Modern Laboratory Medicine,2025,40(05):194-199.[doi:10.3969/j.issn.1671-7414.2025.05.037]
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临床检验定量测定项目统计质量控制程序设计软件的开发与应用()

《现代检验医学杂志》[ISSN:/CN:]

卷:
第40卷
期数:
2025年05期
页码:
194-199
栏目:
质量控制·实验室管理
出版日期:
2025-09-15

文章信息/Info

Title:
Development and Application of the Statistical Quality Control Program Design Software for Clinical Quantitative Measurement Items
文章编号:
1671-7414（2025）05-194-06
作者:
刘佳丽1，王 薇1，陈兵权2，王治国1
1.北京医院国家老年医学中心，国家卫生健康委临床检验中心/北京市临床检验工程技术研究中心，中国医学科学院老年医学研究院，北京 100730;2.北京科临易检信息技术有限公司，北京 100020
Author(s):
LIU Jiali1，WANG Wei1，CHEN Bingquan2，WANG Zhiguo1
1.Beijing Hospital, National Geriatrics Center, National Health Commission Clinical Laboratories Center/Beijing Clinical Laboratory Engineering Technology Research Center, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China;2.Beijing Clinet Information Technology Company, Beijing 100020, China
关键词:
质量控制; 患者风险; 质控规则; 批长度
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2025.05.037
文献标志码:
A
摘要:
目的开发一款统计质量控制（SQC）程序设计软件，帮助实验室设计基于患者风险的全面的SQC程序。方法依据功效函数图、操作过程规范图、基于风险的多级室内质量控制（IQC）方案、IQC频率在线计算工具的模拟原理，整合设计出相应的软件模块，并使用钾项目的数据对软件进行应用。结果在功效函数图、操作过程规范图和IQC频率在线计算工具三个软件模块中，钾项目选择13s/22s/R4s/41s[质控测定值个数（N）=2]进行IQC最佳。在基于风险的多级IQC方案中，可选择13s/22s/R4s/41（sN=2）作为启动规则，同时根据不同的期望报告间隔和最大工作量获得不同的监测规则来达到预期的质量要求。结论临床检验定量测定项目SQC程序设计软件的开发有助于临床实验室评价当前质量水平并选择合适的质控方法，帮助实验室进行质量改进。
Abstract:
Objective To develop a statistical quality control (SQC) program design software to help laboratories design comprehensive SQC programs based on patient risk. Methods Based on the power function diagram, operation process specification diagram, risk-based multi-level internal quality control (IQC) scheme, and online calculator for IQC frequency, corresponding software modules were integrated and designed, and applied the data of potassium project to the software. Results For the power function diagram, operation process specification, and online calculator for IQC frequency, 13s/22s/R4s/41s [Number of quality control measurement values(N)=2] was the best choice for potassium for IQC. In the risk-based multi-level IQC scheme, 13s/22s/R4s/41s (N=2) could be selected as the startup quality control event, while different subsequent bracketing quality control events could be obtained based on different expected reporting intervals and maximum workloads to achieve the expected quality requirements. Conclusion The development of statistical quality control program design soft is proves beneficial for clinical laboratories to assess the current quality level and select appropriate quality control approaches, and assists the laboratories in enhancing quality.

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备注/Memo

备注/Memo:
基金项目：国家自然科学基金委员会（项目编号：81871737）。
作者简介：刘佳丽（1990-），女，本科，主管技师，研究方向：临床实验室质量管理，E-mail：1253480821@qq.com。
通讯作者：王治国（1964-），男，研究员，研究方向：临床实验室质量管理，E-mail：zgwang@nccl.org.cn。
更新日期/Last Update: 2025-09-15