首页|探究POCT凝血检测质量管理策略与实践

探究POCT凝血检测质量管理策略与实践

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目的:评价新投入临床急诊科室便携式凝血仪(LA-100)性能,并与检验科目前使用的全自动血凝分析仪(ACL TOP 300)进行结果比对,探究质量管理策略.方法:通过对2台血凝分析仪检测结果一致性分析,现场质量反馈等方法,全面了解院内临床POCT凝血仪在质量控制与管理存在的问题,并提出针对性纠正措施.结果:便携式凝血仪(LA-100)批内精密度正常、异常水平分别为PT 9.19%和9.29%,ACT 8.97%和8.07%,INR 8.89%和8.87%,APTT 7.47%和8.04%,FIB 8.56%和8.17%,TT 8.21%和8.92%;批间精密度正常、异常水平分别为PT 8.31%和9.77%,ACT 8.31%和8.32%,INR 8.38%和9.45%,APTT 7.20%和8.85%,FIB 9.47%和7.40%,TT 8.79%和9.02%;两台仪器临床样本相关性系数分别为PT r2=0.97、INR r2=0.99、APTT r2=0.92、FIB r2=0.65、TT r2=0.85.22例临床样本分别检测PT、INR、APTT、FIB、TT水平,采用配对t检验比较,差异均无统计学意义(P>0.05).结论:临床投入使用的便携式凝血仪具有良好的重复性与一定的可比性,适用于全血样本.基于实验结果,尝试构建院内POCT凝血同质化管理体系实现人员、仪器、质量、闭环管理,提升一线科室医护人员对POCT质量的实践与认知,保障医疗安全.
Exploring the Quality Management Strategy and Practice of POCT Coagulation test
Objective:To evaluate the performance of a new portable coagulometer (LA-100) put into the clinical emergency department,and to compare the results with the fully automated blood coagulation analyzer (ACL TOP 300) currently used in the laboratory department,and to explore the quality management strategy. Methods:By analyzing the consistency of the test results of the two blood coagulation analyzers and providing on-site quality feedback,the quality control and management problems of the clinical POCT coagulometer in the hospital were comprehensively understood,and targeted corrective measures were proposed. Results:The intra-batch precision of portable coagulation analyzer (LA-100) was normal,and the abnormal levels were 9.19% and 9.29% for PT,8.97% and 8.07% for ACT,8.89% and 8.87% for INR,7.47% and 8.04% for APTT,8.56% and 8.17% for FIB and 8.21% and 8.92% for TT respectively;The normal and abnormal levels of inter-batch precision were 8.31% and 9.77% for PT,8.31% and 8.32% for ACT,8.38% and 9.45% for INR,7.20% and 8.85% for APTT,9.47% and 7.40% for FIB,and 8.79% and 9.02% for TT,respectively;The correlation coefficients of clinical samples between the two instruments are PT r2=0.97,INR r2=0.99,APTT r2=0.92,FIB r2=0.65,TT r2=0.85. 22 clinical samples were tested for PT,INR,APTT,FIB and TT levels respectively,and the differences were not statistically significant when compared by paired t-test (P>0.05). Conclusion:The portable coagulometer put into use in the clinic has good reproducibility and certain comparability,and is suitable for whole blood samples. Based on the experimental results,we try to build a homogenized management system for POCT coagulation in the hospital,realize personnel,instrument,quality and closed-loop management,improve the practice and cognition of the quality of POCT by medical and nursing staff of the first-line departments,and guarantee medical safety.

POCT coagulometerperformance validationcorrelationquality management

金袁苓、潘强龙、蔡啸、涂海霞、朱涛

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南京医科大学附属逸夫医院检验科,江苏南京 211100

POCT凝血仪 性能验证 相关性 质量管理

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(24)