Anderson Nancy
Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Mailstop F-11, Atlanta, GA 30329-4018, Telephone: 404-498-2741.
Clin Microbiol Newsl. 2015 Nov 15;37(22):177-185. doi: 10.1016/j.clinmicnews.2015.11.001. Epub 2015 Nov 6.
As of January 1, 2016, microbiology laboratories can choose to adopt a new quality control option, the Individualized Quality Control Plan (IQCP), under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This voluntary approach increases flexibility for meeting regulatory requirements and provides laboratories the opportunity to customize QC for their testing in their unique environments and by their testing personnel. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process. It includes three main steps, (1) performing a risk assessment, (2) developing a QC plan, and (3) monitoring the plan through quality assessment. Resources are available from the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, American Society for Microbiology, Clinical and Laboratory Standards Institute, and accrediting organizations, such as the College of American Pathologists and Joint Commission, to assist microbiology laboratories implementing IQCP.
自2016年1月1日起,微生物学实验室可以选择采用一种新的质量控制方法,即个性化质量控制计划(IQCP),该计划符合1988年《临床实验室改进修正案》(CLIA)的要求。这种自愿性方法增加了满足监管要求的灵活性,并为实验室提供了机会,使其能够根据自身独特的环境和检测人员,为其检测定制质量控制。IQCP是一种基于风险管理的全面质量方法,用于解决整个检测过程中的潜在误差。它包括三个主要步骤:(1)进行风险评估;(2)制定质量控制计划;(3)通过质量评估监测该计划。医疗保险和医疗补助服务中心、疾病控制和预防中心、美国微生物学会、临床和实验室标准协会以及诸如美国病理学家学会和联合委员会等认证组织,都提供了相关资源,以协助微生物学实验室实施IQCP。