ISO15189：2012与室间质量评价

ISO 1 5 1 8 9：2 0 1 2 and External Quality Assessment

室间质量评价作为一种有效的质量控制工具，可以帮助临床实验室发现检验过程中存在的质量问题，促使实验室采取相应的措施提高检测质量。传统的室间质量评价样品具有一定的基质效应，需要对方法进行分组才能确定靶值。理想的室间质量评价使用具有互换性的样品，具有与患者样品一样的性质，在不同测量程序上的结果具有一致性，通过参考系统建立靶值，可以用来评估与参考系统或指定的比对方法的正确度。在数据统计分析时，可以使用能更真实地反映实验室之间检测结果变异性的稳健统计方法，并采用合适的标准对结果进行评价。如果出现不合格结果，需进行彻底调查，系统地评估检测过程中的每一个方面，找出问题的根源，并采取适当的纠正措施。如果项目没有开展正式的室间质量评价计划，应使用替代性评估程序对这些试验进行性能评估。

External quality assessment （EQA）as an effective tool for quality control can help clinical laboratories to discover quality problems during testing process and prompt clinical laboratories to improve their testing quality.Samples used for traditional EQA frequently have matrix effects which assign the target value by grouping.Ideal samples for EQA are com-mutable which have the same numeric relationship between different measurement procedures as that expected for patients’ samples.And they can assess accuracy against a reference measurement procedure or a designated comparison method.When analyzing,robust statistical method can be used to reflect the variability of testing results between laboratories more truly. And the evaluation standards should be desirable.If unsatisfactory results appear,we should investigate every aspect of tes-ting process,find the root cause,and take corrective action.On condition that no official EQA scheme is launched for some analytes,it is necessary for us to evaluate the performance of analytes by alternative evaluation procedures.