ISO 15189 认可规范在分子病理检测结果质量保证中的应用
| 作者: |
1管文燕,
1樊祥山,
1陈洁宇,
1杨军,
1叶庆
1 南京大学医学院附属鼓楼医院病理科，南京 210008 |
| 通讯: |
叶庆
Email: qingye1998@126.com |
| DOI: | 10.3978/j.issn.2095-6959.2018.10.038 |
摘要
随着精准医疗的发展，分子病理诊断已越来越多地应用于临床。对检测结果质量的管理是确保分子病理检测结果准确性、科学性的基础。笔者根据ISO 15189 CNAS-CL02：2012《医学实验室质量和能力认可准则》中5.6章节《检测结果质量的保证》内容及其在分子诊断领域的应用说明，探讨涉及检测结果质量保证中的应用实践，以期建立完善的质量保证体系，为临床提供优质的分子病理检测服务。
关键词：
ISO 15189；分子病理；检测结果；质量保证
Application of accreditation criteria published by ISO 15189 in quality assurance for results of molecular pathology detection
CorrespondingAuthor: YE Qing Email: qingye1998@126.com
DOI: 10.3978/j.issn.2095-6959.2018.10.038
Abstract
Recent progress in precision medicine has improved the molecular pathology detection to be increasingly applied to diagnose of diseases. It is important for ensuring the accuracy and scientific of pathological examination results. The quality management for results is the basis for ensuring the accuracy and scientific of molecular pathology detection. According to the Chapter 5.6 headed “Quality Assurance for Detection Results” of accreditation criteria for the quality and competence of medical laboratories (ISO 15189 CNAS-CL02: 2012) and the related guidance on the application in the field of molecular diagnostics, the application of criteria in quality assurance for results is discussed in the hope of establishing a complete system, which is the guarantee for providing quality service to clinic.
Keywords：
ISO15189; molecular pathology; detection results; quality assurance