操作过程规范图评价室内质量控制方法的研究.pdfVIP

中华医院管理杂志2004 年 7 月第 20 卷第 7 期　Chin J Hosp Admin ,Jul 2004 , Vol 20 , No. 7 4·37 · ·科室管理· 操作过程规范图评价室内质量控制方法的研究 何进才 　王治国 　刘心亮 　李忠新 　占葆娥 　麻保玉 ( ) 【摘要】　目的 　探讨从分析质量计划模型导出“操作过程规范 OPSpecs ”,并用于评价满足室间质 评性能准则所需的精密度、准确度和质控方法。方法 　常规操作规范以 OPSpecs 图形式表示 ,其描述了 当由特定质控方法提供期望的质量保证水平时 ,不精密度和不准确度的操作限。结果 　OPSpecs 图能用 来比较不同质控方法的操作限和选择适合于特定测定方法精密度和准确度的质控方法。将测定方法的 不精密度和不准确度绘制在 OPSpecs 图上作为操作点 ,然后将其与候选质控方法的操作限相比较。结论 　对所有自动化分析仪试验项目 ,均能采用类似方式进行质控方法的选择和设计。 【关键词】　操作过程规范图 ; 　室内质量控制 ; 　室间质量评价 Study on assessing internal quality control procedures with charts of operational process specifications 　HE Jincai , WANG Zhiguo , LIU Xinliang , et al . Clinical Laboratory Department of Shenzhen Hospital of Traditional Chinese Medicine , Shenzhen 518033 , China ( ) 【Abstract 】　Objective 　To explore the assessment of precision , accuracy , and quality control QC proce ( ) dures needed to satisfy the external quality assessment criteria with “operational process specifications”OPSpecs de rived from an analytical qualityplanning model. Methods 　The routine operating specifications were presented in the form of an OPSpecs chart , which described the operational limits for imprecision and inaccuracy when a desired level of quality assurance was provided by a specific QC procedure. Results 　OPSpecs charts could be used to compare the operational limits for different QC procedures and to select a QC procedure that was appropriate for the precision and accuracy of a specific measurement procedure. The inaccuracy and imprecision observed fo