Clinical Laboratory Improvement Amendments (CLIA)   

临床实验室改进法案（Clinical Laboratory Improvement Amendments，CLIA88）是于1988年颁布的一整套联邦管理标准，它适用于所有检测人体标本的临床检测项目。但不包括药物临床试验和基础研究实验室。

CLIA为各种临床实验室检测设定标准和进行认证。CLIA把临床实验室定义为：以诊断、预防或对疾病或损伤的治疗提供信息，以及评价人体健康状态为目的，而对取自人体的标本进行实验室检测的任何机构。CLIA的目标之一是保证检测结果的准确、可靠和及时，而不论这项检测实在哪里完成的。

在美国，由负责CLIA计划的实施。CLIA计划的资金来源是遍布全美的约189,000家临床实验室所缴纳的会员费。

Clinical Laboratory Improvement Amendments (CLIA) of 1988 are  federal regulatory  that apply to all  testing performed on humans in the United States, except clinical trials and basic research.

CLIA Program

In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a  as any facility which performs  testing on  derived from humans for the purpose of providing information (1) for the , , or treatment of disease or impairment, and (2) for the assessment of health. An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.

 (CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, Division of Laboratory Services.

The CLIA Program is funded by user fees collected from approximately 200,000 laboratories, most located in the United States.