摘要
目的:通过对遂宁地区25家临床实验室13个常规化学项目的飞行检查结果进行分析,了解该地区这些项目检测结果的整体情况,为该地区常规化学项目检测结果互认提供依据。方法:将5份血清标本以飞行检查的方式发放给遂宁地区25家医疗机构的实验室,参评实验室在收到标本后于规定时间内现场完成检测和结果上报。采用CNAS-GL002推荐的简单稳健统计方法计算各项目在5个标本中的简单稳健Z比分数(Z),并对其进行分析;同时,以该地区A实验室的检测结果为靶值,并以卫生行业标准WS/T 403-2012中总允许误差(TEA)的1/2为可接受标准,分析其余实验室与A实验室检测结果的一致性。结果:简单稳健统计分析显示,各项目在5个飞行检查标本中,其简单稳健Z比分数绝对值(|Z|)≤2的实验室比例均在80%及以上,|Z|≥3的实验室比例不超过16%,但仅总胆红素和总蛋白这两个项目|Z|≥3的比例为0;13个项目的一致性分析显示,遂宁地区其他24家实验室与A实验室的一致率为16%~80%。结论:该地区部分临床实验室常规化学检测不能满足区域检验结果互认的要求,各临床实验室应加强人员、实验用水、试剂、校准品、仪器维护保养等方面的培训与管理工作;同时临床检验质量控制中心应加强质量检查及指导,采用飞行检查、定期比对等方式不断提高区域检验结果的一致性,推动临床实验室结果互认工作。
Objective: The results of 13 routine chemical projects in 25 clinical laboratories in Suining were analyzed through flight inspection, so as to understand the overall test results of these projects in the region, and to provide the basis for mutual recognition of the test results of routine chemical items in this area.Methods: Five serum samples were distributed to the laboratories of 25 medical institutions in Suining area by means of flight inspection.After receiving the samples, the laboratories completed the test and reported the results within the specified time.The statistical method recommended by CNAS-GL002 was used to analyze the simple and robust Z-score(Z) of the results of each project.At the same time, the test results of laboratory A in this area were taken as the target value, and 1/2 of the total allowable error(TEA) in the health industry standard WS/T 403-2012 was taken as the acceptable standard to compare the test results of other laboratories and laboratory a.Results: Statistical analysis of 5 flight examination samples showed that the proportion of laboratories with simple and robust Z-score(| Z |) ≤ 2 was 80% or more, the proportion of laboratories with | Z | ≥ 3 was not more than 16%,but only the proportion of total bilirubin and total protein | Z |≥ 3 was 0,the consistency analysis of 13 projects shows that the consistency rate of other 24 laboratories in Suining area with laboratory A is only 16%~80%.Conclusion: The routine chemical testing of some clinical laboratories in Suining area can not meet the requirements of mutual recognition of regional test results.Clinical laboratories should strengthen personnel training and strictly implement the management of experimental water, reagents, calibrators and instrument maintenance.Meanwhile, the clinical laboratory quality control center should strengthen quality inspection and put forward guidance, continuously improve the consistency of regional test results through flight inspection and regular comparison, and promote the mutual recognition of clinical laboratory results.
作者
张丽
蒲泽晏
肖光军
周波
赵明才
刘艳婷
ZHANG Li;PU Zeyan;XIAO Guangjun;ZHOU Bo;ZHAO Mingcai;LIU Yanting(Daying County People's Hospital,Daying 629300,China;Suining Central Hospital,Suining 629000,China)
出处
《临床医药实践》
2022年第12期920-926,共7页
Proceeding of Clinical Medicine
关键词
飞行检查
检验结果互认
质量控制
flight-inspection-survey
mutual recognition of test results
quality control
