个性化质量控制计划及其对临床实验室质量管理的影响

Individualized quality control plan and its impact on quality management of clinical laboratories

个性化质量控制计划(individualized quality control plan,IQCP)是一个基于不同临床实验室风险评估和特定条件而产生的全方位的质量保证方案,由美国联邦医疗保险和医疗补助服务中心(the Centers for Medicare&Medicaid Services,CMS)在42 CFR 493.1256法规条款中颁布,从2016年1月份开始在遵循临床实验室改进法案修正案(Clinical Laboratory Improvement Amendments,CLIA)的临床实验室推行,主要针对非豁免检测项目。本文通过介绍IQCP的内容、使用范围和制定方法,跟进国际上临床实验室和监管机构对IQCP的理解和执行情况,尝试探讨IQCP对中国临床实验室尝试新的质量管理的意义和启发,为进一步探索如何在符合我国国家法律法规的框架下,引导不同地区不同层级检验机构在实验室管理行为上采取针对性的措施和个性化的解决方案提供思路。

The Clinical Laboratory Improvement Amendments （CLIA） individualized quality control plan （IQCP） is a risk-based, objective approach to performing quality control testing. It is based on assessment of the unique laboratory testing in use, patient populations and other aspects （for example, internal quality checks built into new instruments）. IQCP is the implemented under the Centers for Medicare ＆ Medicaid Services （CMS） regulation 42 CFR 493.1256 Standard： Control Procedures, and apply to most CMS-certified current and new non-waived tests. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process, In this article, we introduce the concept of IQCP and discuss the overall situation of IQCP implementation so far. Hopefully, this new idea of quality plan could provide clues on how to improve quality management based on each clinical lab＇s specific situation in China.