CLIA Waived

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) oversee U.S. facilities that conduct laboratory tests on human beings. The main purpose of CLIA is to ensure the accuracy of all lab test results, regardless of location.

There are, however, exceptions to the CLIA regulations for specific testing—including employer drug testing conducted by Substance Abuse and Mental Health Services Administration (SAMHSA)-certified labs.

What Are CLIA Waived Drug Tests?
The CLIA program sets the standards for laboratory testing and issues certificates to facilities across the United States. CLIA Waived drug tests have been granted a waiver based on the seven criteria listed below, approved for home use by the Food and Drug Administration, and included in the CLIA regulations.

How the system works: Each laboratory and examination is evaluated for its level of complexity using a three-point system (with 1 being the lowest level of complexity and 3 being the highest level of complexity).

Criteria for CLIA Waived Drug Tests
Per the test categorization outlined in 42 CFR 493.17, the seven criteria for CLIA Waived status include:

Experience and training
Interpretation and judgment
Knowledge
Reagents and materials preparation
Steps of operation and the corresponding characteristics
System troubleshooting and equipment maintenance
Calibration, quality control, and testing material proficiency

CLIA Waived drug tests are simple and feature a low risk of error. (Please note, however, that this does not make them 100% error-proof.) Drug test dip cards and drug test cups are just two examples of CLIA Waived drug testing solutions.

Are There Requirements for CLIA Waived Drug Screening Kits?
Laboratories that conduct CLIA Waived drug tests require a CLIA certification. There are currently 100 waived tests under the CLIA and over 230,000 laboratories with CLIA Waived status.

Put simply, CLIA Waived facilities help to protect patient safety and meet regulatory compliance. Requirements for CLIA Waived laboratories are as follows:

Enrollment in the CLIA system
Payment of biannual CLIA fees
Adherence to the drug test manufacturer’s screening instructions

Interested in learning more about CLIA Waived drug screening? Please contact us for details.