Interpretation of the guidance on the application of accreditation criteria for the medical laboratory quality and competence in the field of gene amplification testing (version 2013)

doi:10.3877/cma.j.issn.2095-5820.2013.01.008

Abstract

Abstract:

The guidance on the application of accreditation criteria for the medical laboratory quality and competence in the field of gene amplification testing (version 2013) was published in 2013 by China National Accreditation Service for Conformity Assessment (CNAS). There are many updates and changes in the version 2013 compared to the version 2007. The post maintenance verification, new test methodology evaluation and inter-laboratory quality control sections are primarily revised and detailed, which is important for the quality and competence improvement of the gene amplification testing in medical laboratories. This article will introduce the gap analysis between the requirements of these two guidance versions.

Key words: Gene amplification, Medical laboratory

Weiwei Liu, Ming Guan. Interpretation of the guidance on the application of accreditation criteria for the medical laboratory quality and competence in the field of gene amplification testing (version 2013)[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2013, 01(01): 38-42.

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References 18

1	中国合格评定国家认可委员会. 2003 ISO 15189 CNAS-CL02. 医学实验室质量和能力认可准则. 北京：CNAS, 2006.
2	中国合格评定国家认可委员会. CNAS-CL34. 医学实验室质量和能力认可准则在基因扩增检验领域的应用说明. 北京：CNAS, 2007.
3	中国合格评定国家认可委员会. 2007 ISO 15189 CNAS-CL02. 医学实验室质量和能力认可准则. 北京：CNAS, 2008.
4	中国合格评定国家认可委员会. CNAS-CL36. 医学实验室质量和能力认可准则在基因扩增检验领域的应用说明. 北京：CNAS, 2012.
5	Vance GH. College of american pathologists proposal for the oversight of laboratory-developed tests[J]. Arch Pathol Lab Med, 2011,135:1432-1435.
6	胡婷婷, 刘维薇, 张心菊, 等. 荧光PCR结合熔解曲线法检测JAK2 V617F突变方法的建立及其方法学验证[J]. 中华检验医学杂志,2013, 36: 796-800.
7	关明，刘维薇. CAP和ISO15189认可对临床分子诊断方法学验证的要求[J]. 中华检验医学杂志, 2013,36:105-108.
8	Jennings L, Van DV, Gulley ML. Recommended principles and practices for validating clinical molecular pathology tests[J]. Arch Pathol Lab Med, 2009,133: 743-755.
9	胡婷婷, 刘维薇, 陈宇明, 等. 运用不同荧光定量PCR系统检测HBV-DNA定量检测的偏差评估[J]. 中华检验医学杂志，2012, 35:856-858.
10	Allen TC. Quality: walk the walk[J]. Arch Pathol Lab Med, 2011,135:1384-1386.
11	Allen TC, Hammond ME, Robboy SJ. Quality and the college of american pathologists[J]. Arch Pathol Lab Med, 2011,135: 1441.
12	Guzel O, Guner EI. ISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory I[J].Clin Biochem, 2009,42: 274-278.
13	Yanikkaya-Demirel G. ISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory II[J]. Clin Biochem, 2009,42: 279-283.
14	Berwouts S, Morris MA, Dequeker E. Approaches to quality management and accreditation in a genetic testing laboratory[J]. Eur J Hum Genet, 2010,18: s1-19.
15	Mattocks CJ, Morris MA, Matthijs G, et al. A standardized framework for the validation and verification of clinical molecular genetic tests[J].Eur J Hum Genet, 2010, 18:1276-1288.
16	Halling KC, Schrijver I, Persons DL. Test verification and validation for molecular diagnostic assays[J]. Arch Pathol Lab Med, 2012,136: 11-13.
17	Raymaekers M, Smets R, Maes B, et al. Checklist for optimization and validation of real-time PCR assays[J]. J Clin Lab Anal, 2009,23: 145-151.
18	李金明，申子瑜. 正确认识临床实验室认可与提高检验质量之间的关系[J]. 中华检验医学杂志，2007,30:136-139.

07版本条款	13版本条款	修改形式	主要内容
N/A	4.1.1	新增	实验室医疗执业许可以及病理诊断资质要求
5.1.3	4.1.5h	修改	技术管理任职要求
N/A	4.6.2	新增	试剂耗材质检要求
5.1.1	N/A	删除	组织结构图和岗位描述
5.1.11	5.1.2	修改	操作人员执证上岗
5.1.3	5.1.4	修改	实验室负责人任职要求
5.1.6、5.1.9、5.1.10	5.1.11	修改	员工能力评审
5.1.7	N/A	删除	人员授权
5.1.8	N/A	删除	管理权限
N/A	5.1.13	新增	保密申明
5.2.1	5.2.1	修改	实验室分区要求
N/A	5.2.2	新增	风险评估
5.2.4	5.2.4	修改	生物安全柜要求
N/A	5.2.5	新增	环境、温度、湿度、水质
N/A	5.2.9	新增	存储空间及记录要求
N/A	5.2.10	新增	环境清洁及记录要求
5.3.2	5.3.2	修改	设备检测要求
N/A	5.3.4	新增	试剂和耗材要求
N/A	5.3.6	新增	稳压电源要求
N/A	5.3.7	新增	设备故障修复后方法学性能验证
5.3.3	5.4.2	新增	样本留取要求
N/A	5.4.10	新增	病理诊断医师确认标本检测要求
N/A	5.5.1	新增	内部程序分析性能验证要求
N/A	5.5.2	新增	定量检测分析性能验证要求
5.5.1	N/A	删除	标本处理要求
5.5.2	N/A	删除	使用试剂批文
5.6.1	5.6.1	修改	室内质量控制程序
5.6.3	5.6.3	修改	定量检测项目溯源性要求
N/A	5.6.4	新增	能力验证/室间质评要求
N/A	6.6.5	新增	能力验证/室间质评替代方案
N/A	5.6.6、5.6.7	新增	不同检测系统比对要求
N/A	附录A.1-6	新增	分析性能标准

07版本条款	13版本条款	修改形式	主要内容
N/A	4.1.1	新增	实验室医疗执业许可以及病理诊断资质要求
5.1.3	4.1.5h	修改	技术管理任职要求
N/A	4.6.2	新增	试剂耗材质检要求
5.1.1	N/A	删除	组织结构图和岗位描述
5.1.11	5.1.2	修改	操作人员执证上岗
5.1.3	5.1.4	修改	实验室负责人任职要求
5.1.6、5.1.9、5.1.10	5.1.11	修改	员工能力评审
5.1.7	N/A	删除	人员授权
5.1.8	N/A	删除	管理权限
N/A	5.1.13	新增	保密申明
5.2.1	5.2.1	修改	实验室分区要求
N/A	5.2.2	新增	风险评估
5.2.4	5.2.4	修改	生物安全柜要求
N/A	5.2.5	新增	环境、温度、湿度、水质
N/A	5.2.9	新增	存储空间及记录要求
N/A	5.2.10	新增	环境清洁及记录要求
5.3.2	5.3.2	修改	设备检测要求
N/A	5.3.4	新增	试剂和耗材要求
N/A	5.3.6	新增	稳压电源要求
N/A	5.3.7	新增	设备故障修复后方法学性能验证
5.3.3	5.4.2	新增	样本留取要求
N/A	5.4.10	新增	病理诊断医师确认标本检测要求
N/A	5.5.1	新增	内部程序分析性能验证要求
N/A	5.5.2	新增	定量检测分析性能验证要求
5.5.1	N/A	删除	标本处理要求
5.5.2	N/A	删除	使用试剂批文
5.6.1	5.6.1	修改	室内质量控制程序
5.6.3	5.6.3	修改	定量检测项目溯源性要求
N/A	5.6.4	新增	能力验证/室间质评要求
N/A	6.6.5	新增	能力验证/室间质评替代方案
N/A	5.6.6、5.6.7	新增	不同检测系统比对要求
N/A	附录A.1-6	新增	分析性能标准

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