参考文献/References:
[1] 王治国 . 临床检验方法确认与性能验证 [M]. 北京 : 人民卫生出版社 ,2009: 91-92. WANG Zhiguo. Clinical test method validation and performance validation[M]. Beijing: People’s Health Publishing House,2009: 91-92.
[2] Clinical and Laboratory Standards Institude. User evaluation of between-reagent lot variation;Approved Guideline [S]. Wayne: PA, CLSI EP26-A, 2013.
[3] Clinical and Laboratory Standards Institude. Validation of comparability of patient results within one health care system;Approved Guideline(Interim Revision)[S]. Wayne: PA, CLSI EP31-A, 2018.
[4] 王治国 .临床检验生物学变异与参考区间 [M].北京 : 人民卫生出版社 ,2012: 215-232. WANG Zhiguo. Clinical test biological variation and reference interval [M]. Beijing: People’s Health Publishing House, 2012: 215-232.
[5] 国家卫生健康委员会临床检验中心 .2021年内分泌第 2次室间质评统计结果表(2020标准) : 计划编码 NCCL-C-07 [EB]. [2021-11-03].https://www.nccl. org.cn/maincn 00900842346327.pdf. National Center for Clinical Laboratories. Table of statistical results of the second endocrine interventricular quality assessment in 2021 (2020 criteria) : Planned code NCCL-C-07[EB]. [2021-11-03]. https://www.nccl.org.cn/maincn 00900842346327.pdf
[6] 中国合格评定国家认可委员会 . CNAS-CL02-A003: 医学实验室质量和能力认可准则在临床化学检验领域的应用说明 [S]. 北京 : 中国标准出版社 ,2018. China National Accreditation Service for Conformity Assessment . CNAS-CL02-A003: Guidance on the application of accreditation criteria for the medical laboratory quality and competence in the field of clinical chemistry[S]. Beijing: China Standard Press, 2018.
[7] 康凤凤 ,张传宝 ,王薇 . 等 . 正确度验证计划在六西格玛性能评价中的应用 [J]. 临床检验杂志 , 2014, 32(2): 130-132. KANG Fengfeng, ZHANG Chuanbao, WANG Wei, et al. Application of trueness verification scheme in six sigma metric analysis [J]. Chinese Journal of Clinical Laboratory Science,2014,32(2):130-132.
[8] 王治国 . 临床检验质量控制技术 [M]. 2版 . 北京 : 人民卫生出版社 , 2008: 62-63. WANG Zhiguo. Clinical inspection quality control technology [M]. 2nd Ed. Beijing: People’s Health Publishing House, 2008: 62-63.
[9] 中华人民共和国国家卫生健康委员会 .WS/T 407-2012:医疗机构内定量检验结果的可比性验证指南 [S].北京 : 中国标准出版社 .2012. National Health Commission of the People’s Republic of China. WS/T 407-2012: Guidelines for comparability verification of quantitative results with in one health care system [S]. Beijing: China Standard Press, 2012.
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