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The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.
CLIA may refer to: Chemiluminescent immunoassay; Clinical Laboratory Improvement Amendments; Cruise Lines International Association This page was last edited on 20 ...
The merged organization, which uses the CLIA name, is located in Washington, D.C. [1] Established in 1975, Cruise Lines International Association (CLIA) is the world's largest cruise industry trade association based on the number of passenger cruise ships operated by its members.
The Individualized Quality Control Plan (IQCP) is a quality management system under the US Clinical Laboratory Improvement Amendments (CLIA) federal regulatory standards. It is designed to enable regulated medical laboratories to manage the frequency of their quality control. [1] [2]
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Laboratories first began receiving CAP accreditation in 1964, [8] and the organization was later given authority to accredit medical laboratories as a result of the Clinical Laboratory Improvement Amendments of 1988. [9] The CAP publishes checklists containing requirements pertaining to the performance of laboratory tests.
Under the CLIA, it is the role of the FDA to assess the complexity of the in vitro laboratory diagnostic tests. [33] Tests are only scored after the FDA has cleared or approved a premarketing request, or upon request. [36] Manufacturers can apply for CLIA waivers during this premarket approval/clearance process.