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.
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.
The categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA. This categorization includes the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories based on their potential for risk to public health:
Tests of Moderate Complexity
Tests of High Complexity
In Conclusion, CLIA Waived drug tests are to be used:
When Screening Patients for Diagnosis
When Screening for the Purpose of Disease Prevention
When Screening for the Treatment of Disease
When Screening for the Assessment of Health
When Screening for the Assessment of an Impairment
Be aware, not all in-vitro drug tests are Waived, if the product description does not mention a CLIA Waiver then most likely it is not. 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 drug test is right for you, an established brand with a proven track record will remain the safe choice.
The following drug testing products are classified as CLIA Waived to meet the needs of your testing facility. CLIA Waived drug tests have been cleared through a review process of two U.S. government agencies: the FDA and HCFA, the objective of this is to determine that errors in operation will be minimized and that inaccurate test results will not endanger the life of the patient. A CLIA waiver is specific to the manufacturer and the product. Each test method is individually examined before a waiver is granted.