血液分析方法的过程能力与性能及其室内质量控制方法的研究

Research on the Process Capability and Performance and the Internal Quality Control Procedure of the Blood Analytical Methods

目的通过研究临床血液常用指标的过程能力与性能,为血液指标检测方法过程能力与性能的改进以及不同项目质控方案的设计提供重要依据,同时能有效降低血液质控经济成本。方法运用两个水平的未定值全血质控品检测8个常用血液指标,依据美国CLIA'88的PT质量要求确定各血液指标的TEa,计算常用血液项目的过程能力与性能指标,同时作过程能力分析图,6σ水平方法决定图,功效函数图及OPSpecs图。结果通过血液指标过程能力与性能的研究获得了常用血液指标的过程能力与性能指数,建立了合适的血液指标检测方法的质控方法;通过查找并解决一些过程能力与性能不恰当的方法的原因,进行持续质量改进,提高各血液项目检测方法的过程能力,达到既保证质量又降低质控成本的目的。结论临床血液常用指标过程能力与性能的研究是其过程能力与性能改进及质量控制方案设计的基础,其方法适用于所有临床实验室定量指标的过程研究,值得推广应用。

Objective To improve the process capabilities and performances of the blood analytic methods and supply the basis on the design of the internal quality control（IQC） procedures of the blood analytic methods and meanwhile minimize the economics costs in the IQC through researching on the process capability and performance of the methods for the usual blood items in clinical hematology. Methods To define the clinical total allowable error of the usual blood items according to the analytic quality requlremnents of CLIA＇88 in USA and to apply the undefined value whole blood controls of 2 different levels to detect the 8 usual blood items to calculate the process capability and performance indices of the methods for the items and draw automatedly the process capability analytic charts, 6 sigma metric decision charts, power functional charts and operational process specification charts simultaneously. Results Acquired the process capability and performance indecis and selected the appropriate quality control procedures of the methods for the usual blood items according to the research on their process capabilities and performances and took the quality improvements to promote the process capabilities and performances through investigating and solving the problems of the unsatisfactory methods in order to meet the clinical quality requirements and save the costs as well. Conclusion The research on the process capabilities and performances of the items is the fundamental on the promotion of the process capabilitis and performances and on the design for the quality control procedures. The methods are suitable for the research on the process capabilities and performances of all the clinical quantitive items and are worth applying and generalizing in clinic.