基于风险管理的统计质量控制策略研究进展

Advances of statistical quality control plan based on risk management

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.