Amends TCA Title 4 and Title 68, Chapter 29.

The present law Tennessee Medical Laboratory Act generally requires that a person be licensed in order to operate a medical laboratory. The Act also generally requires licensure for any person who acts as a medical laboratory director, supervisor, technologist, technician, laboratory trainee, or special analyst and accepts a specimen for laboratory examination. Present law specifically exempts at least 11 classes of laboratories or laboratory personnel from the Act's licensure requirements.<br /> <br /> This bill adds the following exemptions from the Act's licensure requirements:<br /> <br /> (1) A Tennessee-licensed pharmacy possessing an active Clinical Laboratory Improvement Amendments of 1988 Certificate of Waiver; and<br /> <br /> (2) Medical personnel employed by and performing testing at a medical laboratory that is required to be licensed under present law performing patient tests not affiliated with state government and owned by a private entity (a "private laboratory").<br /> <br /> Present law requires that persons who collect specimens or report the results of an examination for a medical laboratory be under the supervision of a licensed medical laboratory director, medical laboratory supervisor, medical laboratory technologist, or other person designated under the medical laboratory board's rules. This bill adds authorization for medical laboratory directors to monitor medical laboratory personnel remotely.<br /> <br /> Present law authorizes the board to promulgate rules for the definition and performance of waived tests. Present law defines "waived” to mean laboratory tests that may be performed by unlicensed individuals, and that pose no reasonable risk of harm if performed incorrectly. This bill redefines "waived" to mean laboratory tests systems cleared by the U. States food and drug administration for home use and those tests approved for waiver under the federal Clinical Laboratory Improvement Amendments of 1988.<br /> <br /> ON APRIL 12, 2021, THE SENATE ADOPTED AMENDMENT #1 AND PASSED SENATE BILL 982, AS AMENDED.<br /> <br /> AMENDMENT #1 includes hospital-based laboratories within the bill's definition of "private laboratory" and adds to this bill that the following present law provisions apply to medical personnel employed by and performing testing at a private laboratory:<br /> <br /> (A) Notwithstanding item (2) in the above bill summary, the present law provision governing the examination and reports of examination of human specimens under the Act; and <br /> <br /> (B) The present law prohibition on soliciting the referral of specimens to the person's or another medical laboratory or contracting to perform medical laboratory examinations of specimens in a manner that offers or implies an offer of rebates to a person or persons submitting specimens, other fee-splitting inducements, participation in any fee-splitting arrangements, or other unearned remuneration. <br />