Title 68, Health, Safety and Environmental Protection

(1) The board is authorized to adopt, promulgate and publish rules and regulations to effectuate the purposes and provisions of this chapter, which shall include, but not be limited to, the following subject matters:(1) The licensure of all medical laboratories and personnel and/…

(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 thei…

The board shall require reporting by owners or directors of laboratories of infectious diseases for the protection of the public health. The reports shall not be construed as constituting a diagnosis, nor shall any medical laboratory making such report be held liable under the la…

The board shall require medical laboratory directors to submit such reports concerning medical laboratory operations as may be necessary to administer this chapter, such as, but not limited to, changes of personnel, services or programs.

(a) There is created the Tennessee medical laboratory board, which shall consist of thirteen (13) members. (b) The governor shall appoint qualified board members on the dates indicated so that the membership of the board shall be as follows:(1) A pathologist who is licensed as a …

(a) The board shall approve medical laboratories or medical laboratory training facilities to operate schools for training laboratory personnel and to employ medical laboratory trainees for training purposes, upon presentation of satisfactory evidence that such laboratories are s…

(a) No person shall conduct, maintain, or operate a medical laboratory in this state unless a license has been obtained from the board, except laboratories exempt under § 68-29-104. Unless specifically authorized by the board, an individual shall not be permitted to direct more t…

(a) A license to conduct a medical laboratory, where the owner is not the director, shall be issued jointly to the owner and the director for the purposes stated in the application, and they shall be separately and jointly responsible to the board for the maintenance and conduct …

(a) An application for a medical laboratory license shall be made under oath, by the owner and director of the medical laboratory or public official responsible for the operation of a city or county medical laboratory or institution that contains a medical laboratory, upon forms …

(a) A license shall be issued to a medical laboratory to perform only those medical laboratory procedures and tests that are within the specialties or subspecialties in which the medical laboratory director and supervisors are qualified. (b) A license shall not be issued, unless …

A medical laboratory license shall specify, on the face of the license, the names of the owner and director, the procedures or categories of procedures authorized, the period for which it is valid, and the location at which such procedures must be performed. The license shall be …

(a) No person shall act as a medical laboratory director, supervisor, technologist, technician, laboratory trainee or special analyst and accept a specimen for laboratory examination, unless such person has obtained a license and is registered to act in such capacity by the board…

(a) An application for a license as a medical laboratory director, supervisor, technologist, technician or special analyst shall be made under oath on forms provided by the board. (b) The following fees shall apply to this section:(1) A nonrefundable application fee shall be set …

(a) The board shall prescribe minimum qualifications for medical laboratory personnel, to include generalists, specialty and subspecialty categories as dictated by current laboratory practices, and special analysts in microbiology, serology, biochemistry, hematology, immunohemato…

Each licensee must renew the licensee's license on forms provided by the board and pay a fee as set by the board. The fee, in the form of a check or money order, shall accompany the renewal application. If a licensee fails or neglects to register such licensee's license by the pr…

(a) The board shall register as a laboratory trainee, at no cost, each qualified person who desires trainee status in any laboratory that is approved for training by the board. (b) Registration of a medical laboratory trainee shall not be valid for a period in excess of two (2) y…

(a) No person, except patients who are performing tests on themselves by order of their physician, shall examine human specimens without the written request of a physician, an intern or resident in an American Medical Association approved training program, a duly licensed optomet…

(a) The medical laboratory board shall be 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 and regulations for such procedures a…

(a) No person shall represent, or maintain an office or specimen collection station or other facilities for the representation of any medical laboratory situated in this state or any other state, that makes examinations in connection with the diagnosis and control of diseases, un…

Records involving medical laboratory services and copies of requests and reports of laboratory tests shall be kept for a period of time and in a manner prescribed by the board. They shall be made available to authorized personnel of the board during regular operation hours of the…

Each medical laboratory director shall establish the director's own quality control program acceptable to the board, including use of, where applicable, reference or control sera and other biological samples, concurrent calibration standards, and control charts recording.

(1) The board has the power to suspend or revoke a medical laboratory license or to deny the issuance or renewal of a license or deny approval whenever a medical laboratory owner or director or owner of a medical laboratory training facility commits any of the following offenses:…

(1) The board has the power to suspend or revoke the licenses of medical laboratory personnel or special analysts or to deny the issuance of a license or a registration certificate whenever medical laboratory personnel or special analysts commit any of the following offenses:(1) …

The Uniform Administrative Procedures Act, compiled in title 4, chapter 5, shall govern the hearing and judicial review of all proceedings for suspension or revocation of licenses under this chapter.

(1) It is a violation of this chapter for any person to:(1) Operate, maintain, direct or engage in the business of operating a medical laboratory, unless such person has obtained a medical laboratory license from the board, or is exempt under § 68-29-104;(2) Operate, maintain, di…

The performance of any acts specified in § 68-29-129 by any person is a Class B misdemeanor.

The board, through the attorney general and reporter, in addition to the powers and duties expressed in this chapter with respect to the denial of a license, denial of a certificate of registration, and suspension or revocation of a license, is empowered to petition any chancery …

All fees for licensing and registration provided for under this chapter shall be credited to the board and used by the board for the administration of this chapter in accordance with § 9-4-5117.

The commissioner is authorized to enter into agreements pursuant to the Interlocal Cooperation Act, compiled in title 12, chapter 9, with the commissioner's official counterpart in other states to perform on behalf of another state, examinations or tests upon specimens collected …

The board shall receive administrative support from the division of health related boards of the department of health.

(a) In addition to other persons permitted by law or rule to be a medical laboratory director, a person shall be qualified to serve as a medical laboratory director with a restricted license for a hospital licensed under this title for thirty (30) beds or fewer if the person is a…

(a) The board shall promulgate rules governing the assessment of costs against a licensee or other person found by the board to have violated any provision of this chapter. The costs assessed by the board may include only those costs directly related to the prosecution of the cha…

In addition to other persons permitted by law or rule to be medical laboratory directors, a dentist licensed in this state, certified by the American Board of Oral and Maxillofacial Pathology and certified in oral pathology by the Tennessee board of dentistry shall be qualified t…

(a) Notwithstanding any provisions of official compilation Rules and Regulations of the State of Tennessee, Rule 1200-6-1, or any other rule promulgated by the medical laboratory board to the contrary, a Tennessee medical laboratory shall be licensed in accordance with the rules …

(a) As used in this section:(1) “Accountable care organization” or “ACO” means the term as defined by Section 3022 of the federal Patient Protection and Affordable Care Act (Pub. L. No. 111-148), as amended; and(2) “Clinical laboratory testing” means any test as defined under thi…

(a) Each medical laboratory shall have a medical laboratory supervisor readily available for consultations during all hours when tests are performed. (b) A medical laboratory shall not require a medical laboratory supervisor to be on laboratory premises.