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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.
Summary Description CLIA - Brochure 1 - Updated Regulations Brochure How do they affect my laboratory?.pdf English: A brochure outlining the changes for the 2003 Clinical Laboratory Improvement Amendments (CLIA) regulations.
Summary Description CLIA - Brochure 8 - Proficiency Testing DOs and DON'Ts.pdf English: Clinical Laboratory Improvement Amendments (CLIA) brochure for Proficiency Testing
The Centers for Medicare & Medicaid Services (CMS) is a federal agency within the United States Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children's Health Insurance Program (CHIP), and health insurance portability standards.
In some cases, Medicare may require testing within a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Additionally, further criteria may apply to each type of genetic test ...
CLIA may refer to: Chemiluminescent immunoassay; Clinical Laboratory Improvement Amendments; Cruise Lines International Association This page was last edited on 20 ...
The regulations set out specific requirements for "nonidentification." Research — This exception allows disclosure to researchers conducting certain types of research projects. If protected health information is involved, the HIPAA privacy and security rules also apply. Food and Drug Administration (FDA) — PSWP may be disclosed to the FDA
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.