《ISO15189医学实验室认可生化免疫问题三台山2011.11.29.ppt

影响检验程序质量主要因素： 检测系统性能： 正确度（溯源性）；精密度；最低检测限；线性范围（可报告范围）；干扰因素。 检测系统间结果比对： 两个完全不同检测系统？不同批号间？ 标本编号和分样 校准曲线的校准周期与有效性 质控计划： 室内质控、室间质评 异常值提醒与比对： Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. 标本自动编号与分管 双向通讯仪器检测标本的编号？ 手工检测的标本编号？ 一管血标本分管？一管血编两个以上样本号？ Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. 室内质量控制的监控 Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. 室内质控 室内质控目的？ 定值质控品？ 均值确定？ Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. 定性免疫测定质控物浓度的选择 阳性质控标本选择： 可选择S/CO值减去精密度测定中得到的三倍批间CV与该S/CO值的乘积（意即三倍SD）仍大于1的质控血清作监测重复性的室内质控用 S/CO（1-3CV%）=S/CO-3SD ﹥1 S/CO﹥1+3SD S/CO比值可在1.5~4之间 弱阳性质控标本选择： 选择S/CO处于1.0~1.5左右的质控血清以判断每次测定时试剂盒测定下限的有效性。 Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. 异常值提醒与对比 Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. 等级审核制度 化验单签名问题？ 不同职称工作人员审核权限？ 实验室授权签字人评审？ Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. 审核后改动的标本查询 Evaluation only. Created with Aspose.Slides for .NET 3.5 Client Profile . Copyright 2004-2011 Aspose Pty Ltd. 5.7-5.8 检验后程序管理与报告发放 检验后程序质量控制主要内涵： 报告单发放？ 病区？ 门诊？ 检验危急值监控 TAT时间监控与分析 临床反馈与检验咨询 Evaluation only. Created with Aspose.Slides