FDA approved tests done in a clinical laboratory have gone through a rigorous validation process for a specific purpose (a specified disease or condition). Medicare and other agencies or insurers may deem tests that have not undergone this process as "experimental" or without proven clinical utility, even though such tests may be widely used. For example, one may obtain a plasma TNF-alpha, but it is not FDA approved for any purpose and therefore deemed experimental and likely not to be reimbursed.
A Physician's Office Laboratory (POL) may not be subject to the rigorous licensing and inspection requirements as a regular hospital or commerical laboratory. However, the POL may only perform certain "CLIA" waived tests (Clinical Laboratory Improvement Amendments of 1988), typically those tests that serve a purpose for "point of care" (POC) testing and are not complex to perform.
What is a "CLIA-waived" test? As currently defined in the regulation, waived tests are 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.
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The highest volume CLIA-waived tests are:
- Urinalysis (usually dipstick)
- Pregnancy test (qualitative)
- Glucose
- Fecal occult blood
- Lipid panel (cholesterol)
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Provider-performed microscopy procedures may include moderately complex microscopy including vaginal wet mounts, cervical mucus, and urine microscopic examination. Complex testing, including cytopathology and tissue biopsy specimens, goes to an approved laboratory.
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