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中华临床实验室管理电子杂志 ›› 2018, Vol. 06 ›› Issue (04) : 229 -233. doi: 10.3877/cma.j.issn.2095-5820.2018.04.009

所属专题: 文献

质量控制

基于风险管理的统计质量控制策略研究进展
曾玉萍1, 黄亨建1,()   
  1. 1. 610041 成都,四川大学华西医院实验医学科
  • 收稿日期:2018-08-02 出版日期:2018-11-28
  • 通信作者: 黄亨建

Advances of statistical quality control plan based on risk management

Yuping Zeng1, Hengjian Huang1,()   

  1. 1. Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, China
  • Received:2018-08-02 Published:2018-11-28
  • Corresponding author: Hengjian Huang
  • About author:
    Corresponding author: Huang Hengjian, Email:
引用本文:

曾玉萍, 黄亨建. 基于风险管理的统计质量控制策略研究进展[J/OL]. 中华临床实验室管理电子杂志, 2018, 06(04): 229-233.

Yuping Zeng, Hengjian Huang. Advances of statistical quality control plan based on risk management[J/OL]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2018, 06(04): 229-233.

实验医学旨为临床提供可靠的实验室检测结果,从而支持医疗决策和改善患者健康状况。为达到这个目的,实验室质量管理策略经历了不断的变化和进展。传统统计质量控制以误差检出率判断质控方案性能,六西格玛质量管理策略引进了西格玛度量作为过程指数,EP23-A提出了基于风险管理的质量控制计划,以及近年来为不断优化风险管理策略而提出了列线图和风险管理指数等图形工具和方法。本文总结以上质量管理工具,为实验室提供基于风险管理的统计质量控制策略及评价。

Laboratory medicine aims to provide reliable laboratory test results in support of medical decision-making and to improve patient health. To achieve this goal, laboratory quality management strategies have undergone constant changes and progresses. Performance of quality control plans was judged by probability of error detection in traditional statistical quality control. Sigma metrics were introduced as a process index in six sigma quality management strategy. Then quality control plan based on risk management was proposed in EP23-A. And recently, to continuously optimize risk management strategies, graphic tools and methods such as nomogram and risk management index were proposed. This paper summarized the above quality management tools to provide statistical quality control strategies based on risk management and evaluations for laboratory.

图1 基于风险管理的QCP
图2 联合SQC与列线图设计QCP
表1 患者伤害的可接受概率
图3 患者伤害的预期概率
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