CLIA Research Paper

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CLIA Research paper On December 5, 1967, the U.S. enacted Public Law 90-174, which included in Section 5 the "Clinical Laboratories Improvement Act of 1967." CLIA '67 set regulations on the licensing of clinical laboratories and the movement of samples in and out of them across state lines. Laboratories would be eligible for a full, partial, or exempt CLIA-67 license, depending on the laboratory's conducted tests. The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct. This is very important so that there are no errors and that proper procedures are followed when dealing with patient’s specimen. A clinical laboratory is defined as any facility where materials derived from the human body are examined for the purpose of providing information for the diagnosis, prevention, or treatment of disease or the assessment of health. Standards applied to …show more content…

In its 2014 document Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff, the U.S. Food and Drug Administration (FDA) advises its staff that a medical testing device originally rated moderately complex could receive a waiver "if the device is simple to use and the sponsor demonstrates in studies conducted at the intended use sites that the test is accurate and poses an insignificant risk of erroneous results. While a waived test is known to have an acceptably low level of risk, the Centers for Disease Control and Prevention (CDC) reminds administrators and recipients of such tests that no test is 100 percent

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