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Clinical Laboratory Improvement Amendments (CLIA)   

臨床實(shí)驗(yàn)室改進(jìn)法案（Clinical Laboratory Improvement Amendments，CLIA88）是于1988年頒布的一整套聯(lián)邦管理標(biāo)準(zhǔn)，它適用于所有檢測(cè)人體標(biāo)本的臨床檢測(cè)項(xiàng)目。但不包括藥物臨床試驗(yàn)和基礎(chǔ)研究實(shí)驗(yàn)室。

CLIA為各種臨床實(shí)驗(yàn)室檢測(cè)設(shè)定標(biāo)準(zhǔn)和進(jìn)行認(rèn)證。CLIA把臨床實(shí)驗(yàn)室定義為：以診斷、預(yù)防或?qū)膊』驌p傷的治療提供信息，以及評(píng)價(jià)人體健康狀態(tài)為目的，而對(duì)取自人體的標(biāo)本進(jìn)行實(shí)驗(yàn)室檢測(cè)的任何機(jī)構(gòu)。CLIA的目標(biāo)之一是保證檢測(cè)結(jié)果的準(zhǔn)確、可靠和及時(shí)，而不論這項(xiàng)檢測(cè)實(shí)在哪里完成的。

在美國(guó)，由負(fù)責(zé)CLIA計(jì)劃的實(shí)施。CLIA計(jì)劃的資金來(lái)源是遍布全美的約189,000家臨床實(shí)驗(yàn)室所繳納的會(huì)員費(fèi)。

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.