[1]王 晟a,段小勇b,刘兴态a,等.临床POCT检测项目质量管理体系的建立与实践[J].现代检验医学杂志,2019,34(02):147-152.[doi:10.3969/j.issn.1671-7414.2019.02.038]
　WANG Shenga,DUAN Xiao-yongb,LIU Xing-taia,et al.Establishment and Practice of Quality Management Systemfor Clinical POCT Testing Project[J].Journal of Modern Laboratory Medicine,2019,34(02):147-152.[doi:10.3969/j.issn.1671-7414.2019.02.038]
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临床POCT检测项目质量管理体系的建立与实践()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第34卷
期数:
2019年02期
页码:
147-152
栏目:
质量控制·实验室管理
出版日期:
2019-05-11

文章信息/Info

Title:
Establishment and Practice of Quality Management Systemfor Clinical POCT Testing Project
文章编号:
1671-7414(2019)02-147-06
作者:
王 晟a; 段小勇b; 刘兴态a; 童红斌a
(三峡大学第三临床医学院葛洲坝集团中心医院a.检验科; b.急诊医学科,湖北宜昌 443002)
Author(s):
WANG Shenga; DUAN Xiao-yongb; LIU Xing-taia; TONG Hong-bina
(a.Department ofClinical Laboratory; b.Department of Emergency Medical,Gezhouba Group Central Hospital,the Third Clinical Medical College of Three Gorges University,Hubei Yichang 443002,China)
关键词:
即时检测(POCT);  质量管理体系;  室内质控;  室间质评;  性能验证;  比对试验
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2019.02.038
文献标志码:
A
摘要:
目的 通过临床即时检测(POCT)检测项目质量管理体系建立与实践,保证其结果的准确性与及时性。方法 成立临床POCT管理小组,制定覆盖临床POCT检测全过程的质量管理办法,包括项目的申请与审批、制定操作标准和质量管理规范,检测人员的资质确定与授权并定期考核评价,对全院各POCT仪实行准入制与档案化管理以及定期综合评价等方式。结果 质量管理体系运行首月取消了开展不合适的2台POCT仪器及相应的检测项目,随后及时淘汰了5台性能不合格的POCT仪器,并在运行一年后将全院POCT仪器的室内质控、室间质评开展率和合格率及比对试验合格率均提升至100%。结论 通过建立并实施临床POCT检测项目质量管理体系,有效地保证了检测结果的准确性与及时性,保障了检测质量和医疗安全。
Abstract:
Objective Through the clinical testing projectof POCT quality management system establishment and practice,to ensure the accuracy and timeliness of their results.Methods Established aclinical POCT management team to formulate quality management measures coveringthe whole process of clinical POCT testing,including application and approvalof projects,formulation of operational standards and quality management norms,qualification determination and authorization of testing personnel and regular assessment and evaluation,implementation of access system,archival management and periodic comprehensive evaluation of all POCT instruments in the hospital.Results In the first month of the operation of the quality management system,two inappropriate POCT instruments and corresponding testing items were cancelled,and then five unqualified POCT instruments were eliminated in time.After one year of operation,the indoor quality control,the rate of carrying out the external quality assessment and the rate of passing the comparative test were all raised to 100%.Conclusion By establishing and implementing the quality management system of clinical POCT testing project,the accuracy,timeliness of testing results,the testing quality and medical safety can be effectively guaranteed.

参考文献/References:

[1] 龙伟清,陈渡波,詹晓霞,等.即时检测血糖仪与全自动生化分析仪血糖检测结果的比对研究[J].中国卫生检验杂志,2017,27(15):2410-2412. LONG Weiqing,CHEN Dubo,ZHAN Xiaoxia,et al.Comparison of blood glucose detection results between point of care testing blood glucose meter and automatic biochemical analyzer[J].Chin J Health Lab Tec,2017,27(15):2410-2412.
[2] 汪露,肖迪,李辉.POCT血糖仪医院站点管理的质量控制探索[J].当代医学,2016,22(12):58-59. WANG Lu,XIAO Di,LI Hui.Quality control of P-OCT glucose meter hospital site management[J].Contemporary Medicine,2016,22(12):58-59.
[3] 张妍,王薇,何法霖,等.床旁即时检测(POCT)的质量控制[J].现代检验医学杂志,2014,29(3):162-165. ZHANG Yan,WANG Wei,HE Falin,et al.Quality control and quality assurance in point-of-care testing[J].J Mod Lab Med,2014,29(3):162-165.
[4] 高玉琴,范明亮,王浩,等.POCT血糖仪在临床科室全面质量管理中的实践与研究[J].中国卫生检验杂志,2015,25(9):1476-1478. GAO Yuqin,FAN Mingliang,WANG Hao,et al.The research and practiceof POCT blood glucose meter in total quality management in clinical departments[J].Chin J Health Lab Tec,2015,25(9):1476-1478.
[5] 汪怀周,陈燕,岳展伊,等.C反应蛋白测定两种检测系统间结果的比较[J].现代检验医学杂志,2016,31(3):127-130. WANG Huaizhou,CHEN Yan,YUE Zhanyi,et al.Comparison of differentassay system for C-reactive protein detection[J].J Mod Lab Med,2016,31(3):127-130.
[6] 中华医学会检验医学分会,国家卫生和计划生育委员会.2016便携式血糖仪临床操作和质量管理规范中国专家共识[J].中华医学杂志,2016,96(36):2864-2867. Chinese Society of Laboratory Medicine,National He-alth and FamilyPlanning Commission of China.The portable blood glucose meter clinical operation and quality management standard Chinese expert consensus[J].Natl Med J China,2016,96(36):2864-2867.
[7] 宋国威,李立新,秦英军,等.便携式血糖仪质量管理体系建立的探讨[J].河北医科大学学报,2015,36(12):1467-1470. SONG Guowei,LI Lixin,QIN Yingjun,et al.Establishment of qualitymanagement system for portable glucose meter[J].Journal of Hebei Medical University,2015,36(12):1467-1470.
[8] 杨艳,袁蓉,唐旭,等.便携式血糖仪与生化分析仪血糖检测结果的比对及其质量控制分析[J].实用医院临床杂志,2015,12(5):144-147. YANG Yan,YUAN Rong,TANG Xu,et al.The co-mparison of testing results between point-of-care testing glucose meters and biochemical analyzer andanalysis of quality control[J].Practical Journal of Clinical Medicine 2015,12(5):144-147.
[9] 何谦,杨锐华,王琪.非配套脂蛋白试剂的使用性能验证[J].现代检验医学杂志,2016,31(1):125-127. HE Qian,YANG Ruihua,WANG Qi.Performance ve-rification of LP(a)reagents in clinical laboratory[J].J Mod Lab Med,2016,31(1):125-127.
[10] 黄迪,尚陈宇,万泽民,等.强生干化学分析仪开放通道检测血清淀粉样蛋白A的性能验证[J].现代检验医学杂志,2018,33(5):137-141.HUANG Di,SHANG Chenyu,WAN Zemin,et al.Performance verification of themeasurement of serum amyloid A using the open channel of johnson dry chemistry analyzer[J].J Mod Lab Med,2018,33(5):137-141.
[11] 中华人民共和国国家卫生和计划生育委员会.WS/T 406-2012:临床血液学检验常规项目分析质量要求[S].北京:中国标准出版社,2012.National Health Family Planning Commission of the People's Republic of China.WS/T 406-2012:Analytical quality specifications for routine tests in clinical hematology[S].Beijing:China Standard Publishing House,2012.
[12] 周林,许爱萍,刘毓玲,等.PDCA循环在POCT血糖检测中的应用[J].国际检验医学杂志,2017,38(8):1102-1104.ZHOU Lin,XU Aiping,LIU Yuling,et al.Application of PDCA cycle in POCTblood glucose test in[J].Int J Lab Med,2017,38(8):1102-1104.
[13] 朱人杰,邱俊,吴伟华,等.POCT设备网络化实时在线管理系统的建设及应用[J].临床检验杂志,2018,36(6):459-461.ZHU Renjie,QIU Jun,WU Weihua,et al.The construction and application ofPCOT equipment network on-line management system[J].Chin J Clin Lab Sci,2018,36(6):459-461.

备注/Memo

备注/Memo:
作者简介:王 晟(1980-),男,大学本科,副主任检验师,从事临床化学及质量管理,E-mail:11423144@qq.com。 收稿日期:2018-10-23 修回日期:2019-03-02
更新日期/Last Update: 2019-04-30