Do I Need A CLIA Waived Test?

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.

CLIA Waived Test Kits must be proved “accurate” and “easy to perform”, as hard test procedures seem to produce mistakes that could threaten the life of the patient.

Tests are categorized into three different groups and are classified according to the level of complexity: The three levels are Waived, Moderate and High.

A CLIA Waived drug test is one that has been reviewed by the FDA and the HCFA, to determine that errors in operation will be minimized and protect the life of the patient.

What substantiates a Testing environment that should be only using a CLIA Waived test?

The FDA says that a laboratory is any facility that does laboratory testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

You should use a CLIA Waived Drug Test, when testing for diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

Be aware, not all in-vitro drug tests are CLIA Waived, if the product description does not mention a CLIA Waiver then most likely it is not CLIA WAIVED.

Usually, only certain configurations of a drug testing product line are CLIA Waived, so do not make the mistake in assuming that it is. CLIA Waivers for drug tests are not easy to attain and can be costly and timely. Lots of factors are involved as to the quality and accuracy of the test, making sure that there is no risk to the patient.

The old cliche rings true that “you get what you pay for” so when looking for the right product, keep that in mind. As we all know, liability and risk are standard worries. When wondering which CLIA Waived drug test is right for you, an established brand with a proven track record will remain the safe choice.

A CLIA waiver is specific to the manufacturer and the product. Each test method is individually examined before a CLIA waiver is granted.