临床生化定量分析全面质量控制策略的应用

Application of Tatal Quality Control Strategies in Clinical Biochemistry

目的确定实验室每个分析项目的质量要求和性能特征,制定系统化的质量控制总策略,对每个分析项目选择有效的质控方案。方法依据NCCLS C24-A2和CLIA’88建立统计质量控制和非统计质量控制方案,步骤：1根据实验室的不精密度（S）和不准确度（bias）,利用功效函数图和操作过程规范图设计室内质量控制方法,评估误差检出率（Ped）和假失控率（Prf）;2根据误差检出率的大小将分析项目分为三个组：高误差检出率（Ped〉90%）、中等误差检出率（Ped=50%-90%）和低误差检出率（Ped〈50%）;3对高误差检出率（Ped〉90%）的分析项目重点应用统计质量控制,进行最少的非统计质量控制的管理工作;中等误差检出率（Ped=50%-90%）的分析项目,统计质量控制和非统计质量控制的工作都要同等重视;低误差检出率（Ped〈50%）的分析项目,统计质量控制不是质量控制的重点,须重点加强的是非统计质量控制。结论性能良好的分析方法要求较少的质控规则和非统计质量控制的管理工作,性能差的分析方法要求较多的质控规则和更多的非统计质量管理工作。

Objective To define the formulating quality control strategies that are appropriate for the quality requirement and performance characteristics of each testing process and selecte medically useful quality-control procedures for individual test. Methods According to NCCLS document C24-A2 and CLIA＇88（Clinical Laboratory Improvement Act）established a total quality control （TQC）strategies which include statistical quality control and non-statistical quality control,the latter include method performance specification ,preventive maintenance and instrument function checks. The starting for formulating an analytical total quality control strategies is QC planning and QC procedure,then assess its probability of error detection（Ped）and probability of false rejection（Pfr）characteristics. Depend on using of power function graphs and normalized operational process specification chart,the analytical process is then classified into one of three groups based on the Ped ：high Ped〉90% ,moderate Ped：50%-90% and lower Ped〈50%. The process has high Ped 90% for critical systematic error,for these tests the TQC strategy is to rely on statistical QC. And perform the minimun requirements for nonstatistical QC components. Moderate Ped was 50%-90% ,for these tests the TQC strategy is to balance statistical QC with non-statistical QC components. Lower Ped was lower than 50% ,for these tests the TQC strategy is to improve method performance by doing more non-statistical QC components. Conclusion A testing process with better performance require less quality control and non-statistical QC components and one with worst performance require more quality control and more non-statistical QC components.