CLIA Waived drug tests were defined as simple laboratory procedures that are cleared by the FDA for home use and that incorporate methodologies that are so easy and accurate that it is unlikely that mistakes would occur. Another requirement is that they would pose no reasonable risk of harm to a patient if they were performed incorrectly.
CLIA requirements do apply to entities that perform drug test on ..."materials derived from the human body for the purpose of providing information for diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain Federal requirements.
If the tests are performed for these purposes, the organization doing so is considered under CLIA to be a laboratory and must register with the CLIA program.
In these instances, the advantage of using a "CLIA Waived" test is that it "waives" you from having to comply with a long list of laboratory requirements (such as quality control, training, etc).
Must note that CLIA regulations do not apply to settings such as Correctional (i.e. jails, prisons, probation, courts, etc.) or even Workplace markets.
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