§ 68-29-101. Short Title
This chapter shall be known and may be cited as the “Tennessee Medical Laboratory Act.”
§ 68-29-102. Purpose of Chapter
It is the purpose of this chapter to protect the public health, safety, and welfare of the people of this state from the hazards of improper performance by medical laboratories. Medical laboratories provide essential services to the patient by furnishing the medical practitioner with vital information that is essential to a determination of the nature, […]
§ 68-29-103. Chapter Definitions
As used in this chapter, unless the context otherwise requires: “Analytic testing” means that phase of medical laboratory testing, as defined by the board, that can impact the reliability of the results reported; “Board” means the medical laboratory board, created by § 68-29-109; “Collection station” means any place or entity that has as its primary […]
§ 68-29-104. Application of Chapter
This chapter applies to all medical laboratories and medical laboratory personnel within the state, except: An official medical laboratory operated by the United States public health service, the department of veterans affairs and the armed forces; A laboratory operated by a duly licensed physician or optometrist for the sole purpose of testing samples collected from […]
§ 68-29-105. Rules and Regulations
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: The licensure of all medical laboratories and personnel and/or special analysts meeting the licensure requirements of this chapter; The determination of the […]
§ 68-29-106. Inspection of Medical Laboratories
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 […]
§ 68-29-107. Laboratories to Report Infectious Diseases
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 laws of this state for having violated a trust or confidential […]
§ 68-29-108. Reports of Medical Laboratory Operations
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.
§ 68-29-109. Medical Laboratory Board
There is created the Tennessee medical laboratory board, which shall consist of thirteen (13) members. The governor shall appoint qualified board members on the dates indicated so that the membership of the board shall be as follows: A pathologist who is licensed as a physician and certified in clinical and anatomical pathology by the American […]
§ 68-29-110. Schools for Training Laboratory Personnel — Application Fees
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 staffed by qualified personnel and properly equipped and operated to provide training in medical laboratory techniques adequate to prepare […]
§ 68-29-111. License Required to Operate a Medical Laboratory
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 than one (1) medical laboratory. A separate license shall be obtained for […]
§ 68-29-112. Joint License Where Laboratory Owner Is Not Director — Limitation on Application of License
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 of the laboratory or for any violations of […]
§ 68-29-113. Application for Laboratory License — Fee — Term — Renewal
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 provided by the board; provided, that the laboratory is in compliance […]
§ 68-29-114. Issuance of Laboratory Licenses — Restrictions — Qualifications
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. A license shall not be issued, unless the board determines that the medical laboratory is adequately staffed and equipped to […]
§ 68-29-115. Contents of Laboratory License — Display
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 displayed at all times in a prominent place […]
§ 68-29-116. Licenses Required for Medical Laboratory Personnel — Supervision of Employees
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; provided, that this section shall not apply to pathologists certified or eligible for […]
§ 68-29-117. Applications for Licenses for Laboratory Personnel — Fees — Issuance of License — Temporary Licenses
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. The following fees shall apply to this section: A nonrefundable application fee shall be set annually by the board; and An examination fee in the form of a […]
§ 68-29-118. Minimal Qualifications for Medical Laboratory Personnel and Special Analysts
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, immunohematology and biophysics. The board shall issue a license to any person who meets the minimum qualifications and who demonstrates that such person possesses […]
§ 68-29-119. License Renewal — Fees — Penalties
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 prescribed time, the licensee’s […]
§ 68-29-120. Registration of Laboratory Trainees
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. Registration of a medical laboratory trainee shall not be valid for a period in excess of two (2) years.