ABSTRACT
【Objective】 To analyze the quality level of the laboratory pre-analytical phase, so as to take effective quality improvement interventions to further standardize the operation and provide basis for ensuring the quality of blood testing. 【Methods】 Pre-analytical phase quality indicators of blood screening laboratory in Shanghai Blood Center were established, and those had serious impact on blood safety were defined as the sentinel indicators. The pre-analytical quality level of our laboratory from 2018 to 2020 was statistically analyzed in terms of four parts including sample collection, preservation and submission, centrifugation and quality inspection, which contained 17 indicators. 【Results】 Eleven sentinel indicators were established, and the order of peak value from high to low in three years was as follows: " label omission" rated at 0.000 62% (2020), " label error" 0.000 57% (2018), " inappropriate storage of samples before detection" 0.007 39 (2018), " unqualified application form for sample detection" 0.007 39 (2018). The causes were analyzed and relevant measures were taken. Six monitoring indicators were established, and the order of peak value from high to low in three years was as follows: " insufficient sample" rated at 0.002 59% (year 2018), " hemolysis" 0.002 80% (year 2020), " pale color of blood supernatant (diluted)" 0.000 86 (2018), " automatic sampling interfered by blood clot" 0.027 02% (2018). 【Conclusion】 The quality indexes of pre-analytical phase in our laboratory have reached the level of domestic and international clinical laboratories. The establishment of pre-analytical quality indicators and sentinel indicators, with effective analysis and application, can fully record and monitor the quality of each link before laboratory testing, which is helpful to timely identify risks, detect deviations, and quickly implement corrective and preventive measures, thus further ensure the safety of clinical blood use.