Laboratory tests that can be picked up on the job by people with little training fall under the waived category.
The Clinical Laboratory Improvement Amendments of 1988 govern all facilities in the United States that carry out laboratory testing on human specimens for health evaluation or the diagnosis, prevention, or treatment of disease (CLIA). Tests that have been waived include those that have been approved for home use by the FDA and tests that meet the requirements of the CLIA.
Although the CLIA stipulates that waived tests must be straightforward and have a minimal likelihood of producing inaccurate results, this does not imply that they are fully error-proof. Anywhere within the testing process, errors can occur, but they are more likely to do so when the manufacturer's instructions are not followed and when the testing staff is unfamiliar with all facets of the test system.
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