室内质控与质量管理.ppt

质控习惯 养成好习惯-解决问题 5.3 Control Techniques Using Patient Test Results 使用病人测试结果的质控技术 When patient samples are sufficiently stable and when suitable QC samples are not available for routine monitoring, or when an additional check of repeatability is desirable, retesting of selected patient samples on the same measuring system and/or on multiple measuring systems can verify precision or agreement among results from different measuring systems. Results are evaluated based on the expected agreement among the results. If the difference between results exceeds limits based on the measurement imprecision, an investigation is initiated to determine the cause. Repeat testing of a single patient sample on the same measuring system is a supplementary risk mitigation tool. 当病人样本足够稳定时，并且无法为常规监控提供适当的质控样本、或需要额外的重复性检查时，重复检测已选择的病人样本（在相同的检测系统和/或多种检测系统上选择），能够确认来自不同检测系统的结果的精密度或一致性。在预期的结果一致性基础上评估结果。如果结果相差超出（基于测量不精确度）的限值，则需调查并确定原因。在相同检测系统上重复检测单个病人样本也可辅助降低风险。 质控品质量问题 趋势性变化，过年期间，仅使用1台生化分析仪，质控品使用量减少，造成质控品使用时间过长，更换质控品后好转。 临床案例11 离子校准品质量问题 均值漂移。离子高值校准品剩余瓶底，校准后导致质控偏低，更换新校准品后在控。 临床案例12 TP样本针清洗问题 均值漂移。每日工作结束擦拭加样针，但加样针擦拭后，相邻的两根加样针挨在一起，导致加样针清洗不净，带来交叉污染，针位置复位后解决。 临床案例13 TG清洗机构问题 均值漂移。TG相对应的清洗机构吸废液针堵塞，导致废液吸收不净杯清洗不净，从而引起交叉污染，通吸废液针，冲洗清洗机构后解决。 临床案例14 临床案例15 临床案例15 临床案例15 临床案例16 临床案例16 临床案例16 临床案例16 临床案例16 5.3.1 Repeat Testing of Patient Samples 重复检测病人样本 5.3.2 Monitoring Aggregated Patient Results 监控整体病人结果 Trends in the distribution of patient test results can be monitored over time to detect changes in performance, provided the patient population and distribution of test results are relatively stable. This technique eliminates matrix effects and can detect systematic errors. 只要患者人群和测试结果的分布规律相对稳定，可以随时间变化监控病人检测结果的分布趋势来发现“性能变化”。这个技术消除基质效应并能发现系统误差。 / Weve talked about Westgard Rules for decades, and weve talked about Six Sigma for years. So what happens when we try to talk about both at the same time? Westgard Sigma Rules 八、失控情况处理、原因分析及纠正措施 1、失控情况的处理 纠正失控并及时填写失控报告记录 技术主管签字审核 发放检验报告 质控品开瓶记录-质控品质量 校