The clinical laboratory Improvement amendments were established in 1988 as a set of guidelines to specify which drug tests are to be CLIA-waived tests, based on the complexity of the test performed. Tests that meet the requirements are able to be waived from regulatory oversight. Waived tests are defined as simple procedures that are cleared by the FDA for home use and labeled as easy to use and accurate enough that it’s unlikely any mistakes will occur. Another regulatory requirement is that the test must pose no risk to the patient if the test were to be performed incorrectly. Quality standards for laboratories are established by CLIA to ensure reliability, accuracy, and timeliness of the patients test results. CLIA requirements apply to the clinical usage of drug testing. This includes any entity that performs tests on materials derived from the human body in order to provide assessment of the person’s health, information for diagnosis, and treatment or prevention of any impairment or disease. Any company performing tests for these set of purposes are considered by CLIA to be a laboratory and must abide by CLIA regulations, by registering with the CLIA program if they want to receive the benefits.
CLIA testing standards apply nationally and are provided through CMS (Center for Medicare and Medicaid Services). Any laboratory seeking to receive the reimbursement potential from providing CLIA- Waived tests must have a CLIA- waived certificate and use CLIA approved drug screens. CLIA- Waived drug tests reimbursements are provided in accordance with the insurance providers guidelines. For information regarding current CPT codes please reference the American Medical Association’s Coding Resources.
CLIA-Waived Drug Tests (Clinical Laboratory Improvement Amendments – CLIA) utilize very simple and concise procedures that are substantially accurate as to determine the percentages of false or negative results and pose no reasonable risk of harm to the person tested in the vent the drug test were to be erroneously performed. These types of drug tests are approved and cleared by FDA as suitable for home and business use.
Additional details about CLIA-Waived drug test by their type of application are published by the FDA and include information and summary of the data submitted by different manufacturers who have applied to validate the determination that a CLIA-Waived drug test system meets CLIA statutory criteria for waiver, and FDA’s justification for approving their CLIA-Waived application.
These conclusions and decisions by the FDA provide information that is useful for manufacturers preparing future CW submissions and allow the public to be informed.
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