尿液常规检验项目的风险管理

Risk management in urine routine tests

目的探讨及评估尿液常规检验项目在临床检测及应用中存在的风险。方法应用故障模式及影响分析(FMEA)方法评估尿干化学12项及尿有形成分7项的风险等级。绘制鱼骨图分析影响蛋白质和管型准确性的所有可能因素并确定其根本原因。利用头脑风暴及经验制定对策进行效果确认。结果尿干化学12项及尿有形成分7项没有不可接受风险项目,可接受风险项目有11项,其他项目为可忽略风险。根据二八法则,蛋白质和管型为本次风险管理需改善项目。鱼骨图分析得到根本原因为:检验人员没有按复检规则复检尿液;镜检显微镜镜头模糊,看不清尿液成分;尿液标本放置时间过长。效果确认蛋白质阳性尿液标本其管型检出率由1.55%上升至6.83%,差异有统计学意义(P<0.01)。结论通过风险管理,可有效地将尿液常规分析中蛋白质和管型检测风险控制在尽可能低的程度。

Objective To evaluate the risk of urine routine tests in clinical application. Methods The risk levels of urine dry chemical analysis and urine sediment analysis were evaluated by failure mode and effect analysis（FMEA）. Fishbone diagram was used to analyze probable factors and identify causes that may affect the accuracy of protein and cast determinations. The effect was con？rmed by brainstorming and experience sharing. Results There was no unacceptable risk in all urine routine tests,and 11 tests were acceptable. The risk of remaining tests was negligible. According to Pareto rule,the determinations of protein and cast were needed to be improved in risk management. The causes obtained from ？shbone diagram analysis were as follows：examiners did not follow the re-test rules when they did urinalysis;the microscope lens was unclear;the time of urine specimens placed was too long. The determination rate of cast in protein-positive urine specimens increased from 1.55% to 6.83% （P〈0.01）. Conclusions The risks of protein and cast determinations in urine routine tests are undercontrol through this risk management.