2013版《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》改版解读

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)

中国合格评定国家认可委员会2013版《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》,与既往版本有较大更新和改动,尤其在设备维修后的性能验证、新开项目方法学性能评估和室内质量控制方面,要求更为细化严格,新增内容较多,这对提高基因扩增检验的医学实验室质量和能力具有重要的指导意义。本文对此变化解读如下。

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.