CLIA URINALYSIS TESTS IN PHYSICIANS' OFFICES
Urinalysis
CLIA Urinalysis Tests in Physicians' Offices
CLIA regulations cover all laboratory tests conducted medical purposes. Many of these tests no longer require intensive oversight procedures because manufacturers have designed them to be almost foolproof and safe to use. Waived urinalysis tests include those detecting illicit drug use, pregnancy, liver and kidney problems, and blood abnormalities. The ease and speed with which these tests can be performed, and the relatively relaxed CLIA regulations covering their use, are making them increasing popular for use in provider offices.
CLIA Urinalysis Tests in Physicians' Offices
All clinical laboratory services offered in the United States are regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 (Centers for Disease Control and Prevention [CDC], 2005, p. 2). The Centers for Medicare & Medicaid Services (CMS) administers the CLIA program and the CMS, CDC, and FDA are jointly responsible for implementing CLIA regulations.
Waived Laboratory Tests
CLIA regulations draw distinctions between high complexity, moderate complexity, and low complexity tests, due to how error-prone a given test might me and the associated safety concerns (CDC, 2005, p. 2). Low complexity tests are typically...
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