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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.
A National Provider Identifier (NPI) is a unique 10-digit identification number issued to health care providers in the United States by the Centers for Medicare and Medicaid Services (CMS). The NPI has replaced the Unique Physician Identification Number (UPIN) as the required identifier for Medicare services, and is used by other payers ...
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.
CLIA may refer to: Chemiluminescent immunoassay; Clinical Laboratory Improvement Amendments; Cruise Lines International Association This page was last edited on 20 ...
As a result, the average time since last inspection decreased, and the number of hospices that have gone more than six years since an inspection fell below 800. These numbers fell again on Dec. 30, 2014, with the inclusion more recent data adding more than 1,600 inspections.
Logical Observation Identifiers Names and Codes (LOINC) is a database and universal standard for identifying medical laboratory observations. First developed in 1994, it was created and is maintained by the Regenstrief Institute , a US nonprofit medical research organization.
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.
“The number of bad outcomes, birth defects, miscarriage, and pregnancies was terrible,” says Sandra Kweder, former deputy director of the FDA’s Office of New Drugs, which oversaw the ...