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.
As a result, they established provisions for categorizing a test as “waived” which is defined as simple laboratory procedures that are cleared by FDA for home use and that incorporates methodologies that are so easy and accurate that it is unlikely that mistakes would occur, or, if they did occur, there would be no resultant harm.
Essentially using CLIA Waived devices
allows the tester from having to comply with a long list of laboratory requirements such as training, quality control issues, etc.
CLIA requirements are applicable when, “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”.
Are correctional populations exempt from utilizing tests that are CLIA Waived? Until relatively recently it was believed that they were, but this subject has become mildly controversial with some believing that if treatment decisions are to some extent based on the results of a drug test, that they should be CLIA Waived. The majority of testing being conducted within the criminal justice system continues to utilize tests that are not CLIA Waived.