WHAT ARE CLIA WAIVED TESTS?
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 to establish quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. For the purposes of CLIA, a laboratory includes any type of facility that performs laboratory tests on specimens collected from humans. CLIA covers approximately 175,000 laboratory entities, including physician offices.
According to the final CLIA regulations, published on February 28, 1992, the more complicated a test is to run, the more stringent the requirements. Under CLIA, there are three test classifications, listed here in order of least to most complex: waived, moderate complexity, and high complexity. Diagnostics Direct, Inc. specializes in CLIA waived tests, defined as laboratory tests that employ methodologies that are so simple and accurate that mistakes are unlikely and negligible; or pose no reasonable harm to the patient if performed incorrectly.
CLIA requires that all entities that perform diagnostics, including CLIA waived tests, meet certain Federal requirements and register with the CLIA program. Laboratories can obtain one of four types of CLIA certificates, and all certificates authorize the use of waived tests. A Certificate of Waiver is issued to facilities that only perform waived tests. A Certificate for Provider-Performed Microscopy Procedures (PPMP) is issued to facilities that perform tests using a microscope. A Certificate of Registration is issued to facilities running moderate-complexity or high-complexity laboratory tests until they are officially determined to be in compliance. Once this determination is made, they are issued a Certificate of Compliance.
List of Waived Tests
How to Apply for a CLIA Certificate
Contact Your State Office