摘要
目的通过国际标准化组织颁布《医学实验室质量和能力的专用要求》(ISO15189)对迪安病理实验室的监督检查活动中,样本管理现场不符合项分析,探讨当前第三方独立医学病理检验前过程质量管理现状。方法搜集2018—2020年38家病理实验室ISO15189监督检查发现的样本管理不符合项,对应CNAS-CL02:2012认可准则条款编号,根据不符合项所涉及的条款进行分类,统计各条款不符合发生的频次。结果38家病理实验室质量监督检查活动现场共检查样本管理418项,发现不符合241项(57.66%),其中提供给患者和用户的信息24项(5.74%)、申请单信息94项(22.49%)、采集前活动的指导27项(6.46%)、样品运送23项(5.50%)、样品接收13项(3.11%)、检验程序文件化35项(8.37%)、结果复核8项(1.91%)和临床样品的储存、保留和处置17项(4.07%)。结论独立医学实验室病理检查前过程质量管理的薄弱环节主要为申请单信息的填写,这是当前独立医学实验室病理检查质量管理中需要持续改进的主要方向。
Objective To explore the current status of quality management of the pre-process of third-party independent medical pathology tests through the analysis of sample management site nonconformities in the supervision and inspection activities of Dean Pathology Laboratory by the International Organization for Standardization promulgating the Medical laboratories-Requirements for quality and competence(ISO15189).Methods The sample management nonconformities found in the ISO15189 supervision and inspection of 38 pathology laboratories from 2018 to 2020 were collected,corresponding to the CNAS-CL02:2012 accreditation guideline clause numbers,classified according to the clause involved in the nonconformities,and the frequency of the occurrence of each clause nonconformity was counted.Results A total of 418 sample management items were inspected at the sites of 38 pathology laboratories'quality supervision and inspection activities,and 241 non-conformities(57.66%)were found,including 24 items(5.74%)for information provided to patients and users,94 items(22.49%)for information on application forms,27 items(6.46%)for guidance on pre-collection activities,23 items(5.50%)for sample delivery,13 items(3.11%)for sample receipt,documentation of test procedures 35(8.37%)review of results 8 items(1.91%)and storage,retention and disposal of clinical samples 17 items(4.07%).Conclusion The weak link in the quality management of the pre-pathological examination process in independent medical laboratories is mainly the filling in of application form information,which is the main direction for continuous improvement in the current quality management of pathological examination in independentmedical laboratories.
作者
张爱龙
李筠
许励
ZHANG Ailong;LI Yun;XU Li(Department of Pathology,Hangzhou Dian Medical Laboratory Center Co.,Ltd.Hangzhou 310013,China)
出处
《中国研究型医院》
2022年第5期61-63,共3页
Chinese Research Hospitals
关键词
医学
实验室
全面质量管理
Medicine
Laboratories
Total quality management
