Help Center / Are there any exemptions that apply to clinical laboratories performing tests under certain auspices?

Yes, S. 483.801 provides that clinical laboratories owned entirely by practitioners licensed under chapters 458, 459, 460, 461, 462, 463, or 466 and performing services only for patients under their respective care, and not patients referred by another health care provider not affiliated with the provider’s work group, are exempt from regulation under Part II.

Other health care providers this exemption applies to are Advance registered nurse practitioners licensed under part I of Chapter 464 performing provider performed microscopy procedures (PPMP) and persons performing testing in laboratories within a physician office for patients who have been referred by a health care provider that is also affiliated with the respective physician office’s practice.