The following is content from Repertoire June’s cover story, “A Red Flag for Waived?” To read the entire article, click here

In the wake of reports of inaccurate results from Pap smears intended to detect cervical cancer, Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to ensure the accuracy and reliability of all laboratory testing. This legislation, for the first time, extended federal regulation to all laboratories that perform testing on human specimens for the purpose of diagnosing or treating a disease, illness, or assessment of the health of human beings.

Although the Centers for Medicare & Medicaid Services (CMS) has primary responsibility under CLIA for regulating laboratories, CLIA oversight extends to testing on patients who are neither Medicare beneficiaries and Medicaid recipients.  

Categories of tests

CLIA established three categories of tests: waived, moderate complexity, and high complexity.

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. Facilities performing only waived tests are required to obtain a Certificate of Waiver and pay biennial certificate fees.

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. Finally, moderate and high complexity laboratories must have systems and processes for monitoring testing equipment, procedures to ensure proper test performance and accurate results, and an overall plan to monitor the quality of all aspects of the laboratory’s operation ongoing.

Moderate and high complexity laboratories must undergo onsite surveys at least every two years. These surveys may be conducted by the federal CLIA program, a state survey agency under contract with CMS, or private CMS-approved agencies, such as COLA, the Joint Commission on Accreditation of Healthcare Organizations, or the College of American Pathologists.

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