Clinical Laboratory Improvement Amendments (CLIA)
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 require federal oversight for all laboratories, including physician offices, that examine human specimens for the diagnosis, prevention, or treatment of any disease, impairment of health, or health assessment. The vast majority of obstetrician-gynecologists perform tests in their offices that require the office to register their "laboratory" with the Centers for Medicare and Medicaid of obtain some type of CLIA certificate. Example of tests that fall under CLIA include urine pregnancy tests for visual comparison, wet mounts, including preparations of vaginal, cervical, or skin specimens, and urinalysis. Even if an office is not charging fees for testing, the laboratory must still obtain the appropriate CLIA certificate. For more information about CLIA, including a list of waived tests, click here: http://www.fda.gov/cdrh/CLIA/.