室内质量控制失控后患者生化检测结果有效性的评估

摘要

无论是临床实验室管理部门，还是ISO15189，均提出了对室内质量控制（简称室内质控）失控后需对前批次患者样本检测结果进行评估的要求，但都没有提供评估的具体方法。文章以临床化学组的常规生化项目为例，从质控品、质控规则、项目的临床意义等几个方面考虑，以卫生部室间质量评价（简称室间质评）允许总误差的1／2作为最终的评判标准，对室内质控失控后前批次患者生化检测结果有效性的评估进行了初步探讨。通过对2013年全年本实验室临床化学组常规生化共计33个项目进行统计，室内质控失控共计661项次。经过评估，最终需要回收前批次样本检测结果9项次，占全部失控项次的1．3％。由此可见，怎样根据实验室的实际情况合理设置质控规则，节约资源，值得实验室管理者思考。%Although both clinical laboratory administrators and ISO 15189 require to assess determination results from the previous batch of patient specimens after appearing internal quality control out-of-control, they do not provide the detail methods to evaluate them.In this article, we mainly investigate to assess the validity of biochemical determination results after appearing internal quality control out-of-control according to 1/2 allowable total error providing by the external quality assessment of the National Center for Clinical Laboratories ( NCCL ) with considering control materials, the rules of internal quality control, clinical significance and so on.The results of 33 routine biochemical items were analyzed and showed that there were 661 out-of-control cases in 2013.After the assessment, 9 cases required to withdraw the test results in the previous batch of patient specimens, accounting for 1.3%of total out-of-control cases. How to set rational quality control standard and save resources in accordance with the actual situation of the laboratory is worth thinking for clinical laboratory administrators.