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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.
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 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.
The HEW/HHS exam qualified individuals to serve as high complexity general supervisors under Clinical Laboratory Improvement Amendments(CLIA) 1992 without a degree. [2] The exam was administered a total of 7 times: 4 times between 1975 and 1977, once in 1979 and once in 1983, and one last time on August 28, 1987.
The acronym COLA can stand for different terms depending on the context. In a medical context, COLA may stand for: Clinical Laboratory Accreditation: This is a non-profit organization that ...
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.
Before you can get started, you need to take a pregnancy test at a lab or a CLIA-certified doctor’s office. Then you’ll read through and sign pages of informed consent forms, a standard ...