[1]杨佩红,康蓓佩,陈潇,等.临床微生物实验室与ISO15189 医学实验室认可标准常见不符合条款分析及持续改进措施[J].现代检验医学杂志,2020,35(05):159-163.[doi:10.3969/j.issn.1671-7414.2020.05.041]
　YANG Pei-hong,KANG Bei-pei,CHEN Xiao,et al.Analysis of Common Noncompliances between Clinical Microbiology Laboratory and ISO15189 Medical Laboratory Accreditation Standards and Continuous Improvement Measures[J].Journal of Modern Laboratory Medicine,2020,35(05):159-163.[doi:10.3969/j.issn.1671-7414.2020.05.041]
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临床微生物实验室与ISO15189 医学实验室认可标准常见不符合条款分析及持续改进措施()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第35卷
期数:
2020年05期
页码:
159-163
栏目:
质量控制·实验室管理
出版日期:
2020-11-01

文章信息/Info

Title:
Analysis of Common Noncompliances between Clinical Microbiology Laboratory and ISO15189 Medical Laboratory Accreditation Standards and Continuous Improvement Measures
文章编号:
1671-7414（2020）05-159-05
作者:
杨佩红; 康蓓佩; 陈潇; 徐修礼
空军军医大学西京医院检验科，西安 710032
Author(s):
YANG Pei-hong;  KANG Bei-pei; CHEN Xiao;  XU Xiu-li
Department of Laboratory Medicine, Xijing Hospital of Air Force Military Medical University,Xi’an 710032,China
关键词:
临床微生物; 实验室认可; 不符合条款; 持续改进
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2020.05.041
文献标志码:
A
摘要:
目的　回顾总结临床微生物实验室2011~2019 年在ISO15189 医学实验室认可实施过程中发现的不符合条款， 促进质量体系的持续改进。方法　参照《CNAS-CL02:2012 医学实验室质量和能力认可准则》和《CNAS-CL02-A005 医 学实验室质量和能力认可准则在临床微生物学检验领域的应用说明》，总结微生物实验室近十年发现的不符合条款及 采取的纠正、预防措施。结果　在不符合条款构成比中，第一位是CNAS-CL02:2012 条款5.3 设备、试剂和耗材，占 47.37%；第二位是CNAS-CL02-A005 条款5.6 检验结果质量保证，占15.79%；第三位是CNAS-CL02-A005 条款5.5 检 验过程。结论　不断地总结分析不符合条款，持续改进，有利于提高实验室检验质量，保证ISO15189 质量体系的良好 运转，更好地服务于临床。
Abstract:
objective　To review and summarize the noncompliances found in the implementation process of ISO15189 medical laboratory accreditation in clinical microbiology laboratories from 2011 to 2019, and promote the continuous improvement of the quality system. Methods　Refered to“CNAS-CL02: 2012 Medical Laboratory Quality and Competency Accreditation Guidelines”and“CNAS-CL02-A005 Medical Laboratory Quality and Competency Accreditation Guidelines for Clinical Microbiology Testing”, summarized the noncompliances found in the past ten years in the microbiology laboratory and the corrective and preventive measures taken. Results　Among the noncompliances component ratios, the first place was CNASCL02: 2012 clause 5.3 equipment, reagents and consumables, accounting for 47.37%,the second place was CNAS-CL02-A005 clause 5.6 quality assurance of inspection results, accounting for 15.79% ,and the third place was the CNAS-CL02-A005 Clause 5.5 inspection process. Conclusion　 Continuous summary and analysis of noncompliances and continuous improvement are conducive to improving the quality of laboratory tests, ensuring the good operation of ISO15189 quality system and better serving clinical services.

参考文献/References:

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备注/Memo

备注/Memo:
作者简介：杨佩红（1982-），女，本科，主管检验技师，主要从事临床微生物检验质量控制与管理工作。E-mail:yangph329@163.com。
通讯作者：徐修礼，E-mail：xxlxxl@fmmu.edu.cn。
更新日期/Last Update: 2020-10-30