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Physician Office Laboratory
Evaluation Program (POLEP)

The federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) require that all entities performing laboratory procedures register with the Centers for Medicare and Medicaid Services (CMS), and meet quality control, quality assurance, testing personnel, record keeping and other technical requirements. Every entity that tests or examines specimens for the diagnosis, prevention or treatment of any disease or impairment, or for the assessment of the health of a human being is considered a clinical laboratory. The federal law applies to any clinical laboratory even if only a few basic tests are performed and even if the entity does not charge for its services.

In order to qualify as a physician office laboratory (POL), the practice must be operated by individual health care providers or be part of a legally constituted, independently owned and managed partnership or group practice. Laboratories that are owned, managed and/or operated by managed care organizations, hospitals or consulting firms do not qualify for the POL exception and should apply for a clinical laboratory permit through the Clinical Laboratory Evaluation Program.

If the ownership of your practice has changed since the time of original application for a CLIA certificate, please follow change notification process. For additional questions about ownership or CLIA certification of a POL, please contact the Physician Office Laboratory Evaluation Program.