Present law provides that the Tennessee medical laboratory board is responsible for the establishment of the procedures and standards to be used for the proper collection, handling, and preanalytic processing of laboratory samples and may promulgate the necessary rules for such procedures and standards, including licensing. Present law provides that collection stations owned and operated as part of a laboratory licensed in this state do not require an additional license. However, collection stations owned and operated by laboratories in other states are required to have a Tennessee license. This bill revises such licensure provisions to, instead, provide that a collection station operated by a medical laboratory owner that is a licensee of a medical laboratory in this state does not require an additional license, without regard to where specimens collected at the owner's collection stations are transported, as long as the owner of the licensed medical laboratory retains ownership of the medical laboratory and oversight of the collection stations. However, a collection station operated by a person who is not a medical laboratory owner that is a licensee of a medical laboratory located in this state must have a license issued by the board. ON MARCH 17, 2025, THE HOUSE ADOPTED AMENDMENT #1 AND PASSED HOUSE BILL 702, AS AMENDED. AMENDMENT #1 clarifies that the provision requiring the medical laboratory owner of the licensed medical laboratory to retain ownership of the medical laboratory and oversight of the collection stations described in the bill includes maintaining and producing to the Tennessee medical laboratory board, in the event of a complaint investigation, all relevant and non-privileged records associated with the collection stations for purposes of board oversight.

Statutes affected:
Introduced: 68-29-122(c), 68-29-122
Amended with HA0067 -- 03/17/2025: 68-29-122(c), 68-29-122