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.