2024 Tennessee Code
Title 68 - HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION (§§ 68-1-101 — 68-221-1319)
Health (§§ 68-1-101 — 68-60-101)
Chapter 29 - TENNESSEE MEDICAL LABORATORY ACT (§§ 68-29-101 — 68-29-139)
Section 68-29-106 - Inspection of medical laboratories, accreditation

• (a) The board is authorized to require the inspection of the premises and operations of all medical laboratories subject to licensure under this chapter, for the purpose of studying and evaluating the operation, supervision, and procedures of the facilities, and to determine their effect on the health and safety of the people of this state. For this purpose, authorized personnel of the department have the right to enter upon such premises during working hours. Any person obstructing such entry shall be in violation of this chapter.

• (b) Notwithstanding subsection (a), a rural hospital-based laboratory shall maintain, in addition to a license issued by the board, at least one (1) of the following:
  • (1) An active Clinical Laboratory Improvement Amendments of 1988 (CLIA) license that includes a certificate of accreditation from an approved accrediting organization recognized under CLIA or by the applicable state agency with designated authority to grant CLIA certification;
  • (2) An active certificate of registration;
  • (3) An active certificate of compliance; or
  • (4) A certificate of hospital accreditation as described in subsection (c).

• (c) Hospital accreditation may be obtained from the health facilities commission, the department of health, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), DNV Healthcare, or another organization that is authorized to survey hospitals for medicare enrollment purposes by the United States department of health and human services to comply with a condition of participation in the medicare program in accordance with current requirements of the medicare program.

Amended by 2024 Tenn. Acts, ch. 1046,s 2, eff. 5/28/2024.

Acts 1967, ch. 355, § 6; T.C.A., § 53-4106; Acts 1989, ch. 467, § 3.

See Executive Order No. 36 (5/12/2020), which suspended the provisions of Tennessee Code Annotated, T.C.A. 68-29-106, to the extent necessary to suspend the requirement that the Department of Health conduct inspections for medical laboratory applicants for licensure if the applicant laboratory is physically located in the same location where another licensed medical laboratory was located within the thirty (30) days preceding the submission of the new application.