[1]张金彪,代荣琴.ISO 15189 医学实验室认可标准下血细胞分析仪故障修复后的检验质量验证[J].现代检验医学杂志,2020,35(05):168-172.[doi:10.3969/j.issn.1671-7414.2020.05.043]
 ZHANG Jin-biao,DAI Rong-qin.Verification of Inspection Quality after Repair of Blood Cell Analyzer Failure by ISO 15189 Medical Laboratory Accreditation Standards[J].Journal of Modern Laboratory Medicine,2020,35(05):168-172.[doi:10.3969/j.issn.1671-7414.2020.05.043]
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ISO 15189 医学实验室认可标准下血细胞分析仪故障修复后的检验质量验证()
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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:
168-172
栏目:
质量控制·实验室管理
出版日期:
2020-11-01

文章信息/Info

Title:
Verification of Inspection Quality after Repair of Blood Cell Analyzer Failure by ISO 15189 Medical Laboratory Accreditation Standards
文章编号:
1671-7414(2020)05-168-05
作者:
张金彪1代荣琴2
1. 河北省沧州中西医结合医院实验诊断科, 河北沧州 061001; 2. 沧州医学高等专科学校医学技术系, 河北沧州 061001
Author(s):
ZHANG Jin-biao1DAI Rong-qin2
1.Department of Laboratory Diagnosis, Cangzhou Integrated Traditional Chinese and Western Medicine Hospital, Hebei Cangzhou 061001,China;2.Department of Medical Technology of Cangzhou Medical College, Hebei Cangzhou 061001,China
关键词:
医学实验室认可血细胞分析仪故障修复质量验证
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2020.05.043
文献标志码:
A
摘要:
在ISO 15189 实验室认可管理模式下,医疗设备发生故障时,如何进行修复后验证,实验室应该根据CNASCL02 系列文件的相关规定进行一系列验证操作:更新标识、修复后验证、故障前追溯。对标准文件的理解程度和行为 规范是影响检验质量的重要原因,也是不符合项的主要来源,对CNAS-CL02 和CNAS-CL02-A001 中相关设备维修条 款是否理解透彻,是正确实施验证的前提。如何根据故障原因科学、适宜的选用验证方法是验证成功的关键。以此方可 保证故障修复后的检验质量。
Abstract:
How to perform post-repair verification when the medical equipment failed, by the laboratory accreditation management mode of the ISO 15189, the laboratory should perform a series of verification operations according to the criterions of the CNAS-CL02 refered the series of documents: update identification,post-repair verification and traceability before failure. The understanding of standard documents and codes of conduct were the most important reasons that affected the quality of inspections, and were also the main source of non-compliance. A thorough understanding of the relevant equipment maintenance terms in CNAS-CL02 and CNAS-CL02-A001 was a prerequisite for correct implementation of verification. How to choose the appropriate verification method according to the cause of the failure was the key to successful verification. In this way, the quality of inspection after fault repair could be guaranteed.

参考文献/References:

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相似文献/References:

[1]孟 欣,王 刚,袁 莉,等.Sysmex血细胞分析仪白细胞分类计数校准方法的建立与验证[J].现代检验医学杂志,2016,31(01):101.[doi:10.3969/j.issn.1671-7414.2016.01.029]
 MENG Xin,WANG Gang,YUAN Li,et al.Establishment of Method and Verification for Leukocyte Differential Count of Sysmex Hematology Analyzer[J].Journal of Modern Laboratory Medicine,2016,31(05):101.[doi:10.3969/j.issn.1671-7414.2016.01.029]
[2]洪 俊,饶永彩.XN-9000血细胞分析仪筛查外周血中Sezary细胞的临床价值研究[J].现代检验医学杂志,2017,32(03):92.[doi:10.3969/j.issn.1671-7414.2017.03.025]
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备注/Memo

备注/Memo:
作者简介:张金彪(1982-),男,硕士,副主任技师,主要从事血液病检验及出血与血栓性疾病的预防和诊断,E-mail:zjb7829325@163.com。
通讯作者:代荣琴(1982-),女,硕士,副教授,副主任技师,主要从事检验设备及医学检验教学工作,E-mail:zyx7829325@163.com。
更新日期/Last Update: 2020-10-30