Background:
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 defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

This means if you are a researcher who is personally performing tests on any specimens collected from patients (i.e. pregnancy urine testing) outside of a designated and certified laboratory, you are still subject to CLIA. The level of CLIA regulation your facility may be subject to is dependent upon the category of tests you perform.

Therefore, if you are not using the hospital or clinic labs, you are required to register/enroll your facility with CLIA.


Regulatory Categories for Laboratory tests:  
CLIA established three categories of tests: waived tests, moderate complexity tests, and high complexity tests.

Waived Tests -- simple tests with small chance of error or risk -- are exempt from virtually all CLIA rules, so long as testing is performed in strict compliance with the manufacturers’ instructions. The facility is still required to register/enroll with CLIA .

Waived Tests are defined as simple laboratory examinations and procedures that are:

• cleared by the Food and Drug Administration (FDA) for home use;
• employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or
• pose no reasonable risk of harm to the patient if the test is performed incorrectly.

For more information on CLIA Waivers, click here.

Moderate and high complexity testing, on the other hand, are subject to regulations setting minimum qualifications for all persons performing or supervising these tests, along with corresponding responsibilities for each position in the lab. These laboratories must also participate successfully in approved proficiency testing programs, which provide an external evaluation of the accuracy of the laboratory’s test results.

For more information regarding categorization criteria for tests, click here.