2023 Tennessee Code › Title 68 - HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION (§§ 68-1-NEW — 68-221-1319) › HEALTH (§§ 68-1-NEW — 68-6-201) › Chapter 29 - TENNESSEE MEDICAL LABORATORY ACT (§§ 68-29-101 — 68-29-139) › Section 68-29-104 - Application of chapter

This chapter applies to all medical laboratories and medical laboratory personnel within the state, except:
(1)
An official medical laboratory operated by the United States public health service, the department of veterans affairs and the armed forces;
(2)
A laboratory operated by a duly licensed physician or optometrist for the sole purpose of testing samples collected from their own patients; provided, however, that if samples for testing are received from other sources, all of this chapter shall apply;
(3)
Laboratories operated and maintained exclusively for research and teaching purposes, involving no patient or public health services whatsoever. Schools operated to train medical laboratory personnel are not included in this exception;
(4)
Medical laboratory personnel or other persons specifically exempt by rules promulgated under authority of this chapter; provided, that such rules shall specifically exempt each duly licensed physician holding a valid certificate of waiver issued by the United States secretary of health and human services, pursuant to the Clinical Laboratory Improvement Act of 1988 (
42 U.S.C. § 263a
), whenever and wherever the physician is engaged in the performance or supervision of laboratory examinations and procedures included within the scope of the certificate of waiver;
(5)
Any postsecondary school accredited by an agency recognized or approved by the Council on Postsecondary Accreditation (COPA), unless the postsecondary school operates a "medical laboratory" as defined in §
68-29-103
. Postsecondary schools that train medical laboratory personnel are included in the definition. However, this chapter does not apply to schools that teach medical assistants; provided, that such schools teach only basic, simple laboratory tests as one (1) component of the overall curriculum, and the tests are taught by a licensed medical laboratory technologist. The list of tests that can be taught shall be approved by the board and published in the regulations promulgated under the authority of this chapter. The schools shall not include in their advertisement any statement indicating that they train persons for employment in medical laboratories either in this state or any other state; further, the schools shall expressly state in their catalogs that the curriculum does not train the student for employment in medical laboratories either in this state or any other state;
(6)
Screening programs conducted by for-profit hospitals or nonprofit organizations or in conjunction with conferences sponsored by an established or recognized association of elected state government officials, staff of elected state government officials or both officials and staff, or any other group or association that is an umbrella organization for such officials, staff, or both officials and staff and if the state pays membership dues to such conference; provided, that these programs are under the direct supervision of a physician licensed pursuant to title 63, chapter 6 or 9, and a letter of exemption has been issued to the organization by the board. However, screening program test results from conferences, conducted by an established or recognized association of elected state government officials, staff of elected state government officials or both officials and staff, or any other group or association that is an umbrella organization for such officials, staff, or both officials and staff and if the state pays membership dues to such conference, may be submitted to the individual;
(7)
Licensed nurses and licensed respiratory care therapists, technicians and assistants employed by a licensed home care organization, with respect to procedures that:
(A)
Are performed pursuant to the written order of a licensed physician;
(B)
Involve the use of devices approved for home use by the food and drug agency; and
(C)
Are included within the scope of a valid certificate of waiver or other certificate issued to a licensed home care organization by the secretary of health and human services, pursuant to the Clinical Laboratory Improvement Act of 1988;
(8)
Laboratories under the jurisdiction of county health departments in the state of Tennessee and such other laboratories as defined by the board;
(9)
Laboratories operated for the sole purpose of providing medical services in student health programs as approved by the board;
(10)
Laboratories operated for the sole purpose of providing medical services to support employees in the workplace environment, in an occupational health program, as approved by the board;
(11)
Public health laboratory testing personnel employed by the department, while they are performing work at a medical laboratory operated by the state;
(12)
A pharmacy possessing an active Clinical Laboratory Improvement Amendments of 1988 (CLIA) Certificate of Waiver; and
(13)
Medical personnel employed by and performing testing at a private laboratory.
Amended by 2021 Tenn. Acts, ch. 495, s 3, eff. 5/25/2021.
Amended by 2018 Tenn. Acts, ch. 788, Secs.s 1, s 2 eff. 4/20/2018.
Acts 1967, ch. 355, § 4; 1975, ch. 365, §§ 2, 10; 1980, ch. 475, § 2; 1981, ch. 236, §§ 2-6; 1982, ch. 837, § 1; T.C.A., § 53-4104; Acts 1989, ch. 467, § 12; 1993, ch. 295, § 5; 1993, ch. 326, § 1; 1995, ch. 369, § 1; 1996, ch. 647, §§ 3, 4; 1999, ch. 380, § 1; 2002, ch. 588, § 1.