Sharp Susan E, Miller Melissa B, Hindler Janet
Kaiser Permanente, Department of Pathology, Portland, Oregon, USA
University of North Carolina, School of Medicine, Pathology and Laboratory Medicine, Chapel Hill, North Carolina, USA.
J Clin Microbiol. 2015 Dec;53(12):3719-22. doi: 10.1128/JCM.02385-15. Epub 2015 Oct 7.
The Center for Medicaid and Medicare Services (CMS) recently published their Individualized Quality Control Plan (IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]), which will be the only option for quality control (QC) starting in January 2016 if laboratories choose not to perform Clinical Laboratory Improvement Act (CLIA) [U.S. Statutes at Large 81(1967):533] default QC. Laboratories will no longer be able to use "equivalent QC" (EQC) or the Clinical and Laboratory Standards Institute (CLSI) standards alone for quality control of their microbiology systems. The implementation of IQCP in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown.
医疗保险和医疗补助服务中心(CMS)最近发布了其个性化质量控制计划(IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]),如果实验室选择不执行《临床实验室改进法案》(CLIA)[《美国法规大全》81(1967):533]规定的默认质量控制,那么从2016年1月起,该计划将成为质量控制(QC)的唯一选择。实验室将不再能够仅使用“等效质量控制”(EQC)或临床和实验室标准协会(CLSI)的标准来对其微生物学系统进行质量控制。临床微生物学实验室实施IQCP几乎肯定会增加负担,而其带来的益处目前尚不清楚。