CLIA Waived Information

Overview

In the United States, all laboratory testing performed on humans, with the exception of research, is regulated by the Centers for Medicare and Medicaid Services (CMS). This testing, including drug testing, is regulated through the Clinical Laboratory Improvement Amendments (CLIA). The objective of CLIA is to ensure accurate, reliable, and quality laboratory testing.

The FDA categorizes commercially marketed tests into one of the three CLIA categories:

• Waived Tests
• Moderately Complex Tests
• Highly Complex Tests

CLIA Waived tests are the least complex and easiest to use. The manufacturer has proven that an untrained person can get accurate results by following the instructions provided with the tests. The advantage of using a CLIA Waived test is that you don’t need a highly trained laboratory technician to administer the test; thus the cost of testing is more economical and can be performed in a timelier manner.

CLIA requires all entities that perform tests on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings” to meet Federal requirements. This includes using a CLIA Waived test. The entity must register with the CLIA program, and is considered by CLIA to be a laboratory. To receive Medicare or Medicaid payments, these clinical laboratories must register and be properly CLIA certified.

Certificate of Waiver Laboratories (COW)

Certificate of Waiver laboratories (COW) are only allowed to perform tests that are determined by the FDA and CDC to be CLIA Waived. This is to ensure the risk of error is low. The COW laboratories must enroll in the CLIA program, pay certification fees, and follow the test instructions supplied by the manufacturer.

Applying for a CLIA Certificate

Visit the Centers for Medicare and Medicaid Services for information on applying for a CLIA Certificate.

Access the Certificate Application here (PDF).

Additional Information

Center for Medicare & Medicaid Services CLIA Waived Information (PDF)

Excellent resource on applying for a CLIA Certificate as well as answering frequently asked questions on the Clinical Laboratory Improvement Amendments.

Certificate of Waiver Laboratory Project Section of the CMC website dedicated to CLIA information

CLIA Waived Drug Tests Our POCTestSupply.com drug tests that are FDA approved and CLIA Waived