血液筛查实验室检测前哨兵指标的建立与应用  

Establishment and application of sentinel indicators of pre-analytical phase in blood screening laboratory

作　　者：蔡茵[1] 郑岚[1] 翁逸峰 奚珏[1] 邱玲 周国平[1] CAI Yin;ZHENG Lan;WENG Yifeng;XI Jue;QIU Ling;ZHOU Guoping(Shanghai Blood Center,Shanghai 200051,China)

机构地区：[1]上海市血液中心,上海200051

出　　处：《中国输血杂志》2021年第11期1269-1273,共5页Chinese Journal of Blood Transfusion

摘　　要：目的通过分析本实验室检测前环节的质量水平,以采取有效的质量改进措施,进一步规范各项操作,为保证血液检测质量提供依据。方法建立本中心血液筛查实验室检测前质量指标,并定义其中对血液安全存在严重影响的指标为哨兵指标,从标本采集、保存与送检、离心、质量检查4个环节、17项指标对本实验室2018~2020年检测前质量水平进行统计与分析。结果建立哨兵指标11项,3年内出现峰值为:标签遗漏率0.000 62%(2020年)、标签错误率0.000 57%(2018年)、检测前过程中发生标本未妥善保存率0.007 39%(2018年)、标本检测申请单不符合要求率0.007 39%(2018年)。对其发生的原因进行分析,并采取相关措施。建立监测指标6项,3年内出现峰值为:标本量不足率0.002 59%(2018年)、标本溶血率0.002 80%(2020年)、标本上清液颜色淡(标本被稀释)率0.000 86%(2018年)、标本存在凝块影响自动化加样率0.027 02%(2018年)。结论本实验室检测前各项质量指标结果均达到国内及国际临床实验室水平。建立血站血液筛查实验室检测前质量指标,且设立哨兵指标,并有效分析、运用,能够全面记录并监控实验室检测前各环节质量,有助于及时识别风险、发现偏差,迅速实施纠正和预防措施,从而进一步保障临床用血安全。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.

关 键 词：哨兵指标 检测前过程 血液筛查 

分 类 号：R446[医药卫生—诊断学]