As used in this chapter, unless the context otherwise requires:

(1) “Analytic testing” means that phase of medical laboratory testing, as defined by the board, that can impact the reliability of the results reported;

Terms Used In Tennessee Code 68-29-103

  • Board: means the medical laboratory board, created by §. See Tennessee Code 68-29-103
  • Commissioner: means the commissioner of health. See Tennessee Code 68-29-103
  • Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
  • Council: means the public health council, as defined in §. See Tennessee Code 68-29-103
  • Department: means the state department of health, including the public health council [repealed]. See Tennessee Code 68-29-103
  • Medical laboratory: means any institution, building, or place in which operations and procedures for the microbiological, serological, chemical, hematological, immunohematological, or biophysical examination of specimens taken from the human body are performed to obtain information for diagnosis, prophylaxis, or treatment or where any examination, determination, or test is made on any sample used as a basis for health advice, or where any sample is collected for the purpose of transfusion or processing of blood or blood fractions, or for the training of medical laboratory personnel. See Tennessee Code 68-29-103
  • Medical laboratory director: means a person who is responsible for the administration of the technical and scientific operation of a medical laboratory, including supervision of procedures for testing and the reporting of results. See Tennessee Code 68-29-103
  • Medical laboratory personnel: includes the medical laboratory director, supervisor, technologist, or technician, but does not include medical laboratory assistants, trainees, or other persons employed by a medical laboratory to perform clerical or other administrative responsibilities involving no laboratory test. See Tennessee Code 68-29-103
  • Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
  • Person: means any individual, firm, partnership, association, corporation, municipality, political subdivision, or any other entity whether organized for profit or not. See Tennessee Code 68-29-103
  • Pharmacy: means a pharmacy licensed by the board of pharmacy pursuant to title 63, chapter 10. See Tennessee Code 68-29-103
  • Record: means information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in a perceivable form. See Tennessee Code 1-3-105
  • State: when applied to the different parts of the United States, includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
  • United States: includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
(2) “Board” means the medical laboratory board, created by § 68-29-109;
(3) “Collection station” means any place or entity that has as its primary purpose either the collection of specimens directly from patients or the bringing together of specimens after collection for the purpose of referral to a medical laboratory where testing is performed;
(4) “Commissioner” means the commissioner of health;
(5) “Council” means the public health council, as defined in § 68-1-501 [repealed];
(6) “Department” means the state department of health, including the public health council [repealed];
(7) “Designated Entity” means an entity that performs actions or functions on behalf of the provider, payer or patient for the purposes of creating an electronic health record;
(8) “Independent laboratory” means a medical laboratory performing patient tests that is independent both of attending and consulting physicians’ offices and independent of a hospital;
(9) “Medical laboratory” means any institution, building, or place in which operations and procedures for the microbiological, serological, chemical, hematological, immunohematological, or biophysical examination of specimens taken from the human body are performed to obtain information for diagnosis, prophylaxis, or treatment or where any examination, determination, or test is made on any sample used as a basis for health advice, or where any sample is collected for the purpose of transfusion or processing of blood or blood fractions, or for the training of medical laboratory personnel;
(10) “Medical laboratory director” means a person who is responsible for the administration of the technical and scientific operation of a medical laboratory, including supervision of procedures for testing and the reporting of results;
(11) “Medical laboratory evaluation program” means a program of evaluating the proficiency of medical laboratories by the department;
(12) “Medical laboratory owner” means a person or agency in whom is vested the rights of control, possession, and dominion of a medical laboratory, and, for the purposes of this chapter, includes a county, municipality, or any other owner of an institution operating a medical laboratory;
(13) “Medical laboratory personnel” includes the medical laboratory director, supervisor, technologist, or technician, but does not include medical laboratory assistants, trainees, or other persons employed by a medical laboratory to perform clerical or other administrative responsibilities involving no laboratory test;
(14) “Medical laboratory supervisor” means a person who, under the general supervision of a medical laboratory director, supervises technical personnel, performs tests requiring special scientific skills, and, in the absence of the director, is held responsible for the proper performance of all medical laboratory procedures and the reporting of results;
(15) “Medical laboratory technician” means any person other than the medical laboratory director, supervisor, technologist, or trainee who functions under the supervision of a medical laboratory director, supervisor, or technologist and performs only those medical laboratory procedures that require limited skill, responsibility, and a minimal exercise of independent judgment;
(16) “Medical laboratory technologist” means a person who performs tests that require the exercise of independent judgment and responsibility with minimal supervision by the director or supervisor, in only those specialties or subspecialties in which the technologist is qualified by education, training, and experience;
(17) “Medical laboratory trainee” is a person enrolled in a program accredited by an accrediting agency accepted by the board; or who, in a limited laboratory specialty or specialties for which there is no accredited program available, works and trains under the supervision of a director, supervisor or technologist qualified in the specialty or specialties. A trainee may perform procedures only under direct and responsible supervision of a duly licensed director, supervisor or technologist, but may not report test results;
(18) “Person” means any individual, firm, partnership, association, corporation, municipality, political subdivision, or any other entity whether organized for profit or not;
(19) “Pharmacy” means a pharmacy licensed by the board of pharmacy pursuant to title 63, chapter 10;
(20) “Physician” means any doctor of medicine or doctor of osteopathy duly licensed to practice the doctor’s profession in Tennessee;
(21) “Point of care laboratory testing” means those tests performed by health care professionals, not licensed by this chapter, upon approval by the board; provided, that the testing is performed outside the duly licensed laboratory, and under the auspices of a laboratory required to be licensed by the division of health care facilities in the department of health, pursuant to this chapter;
(22) “Private laboratory”:

(A) Means a medical laboratory that is required to be licensed under this title performing patient tests not affiliated with state government and owned by a private entity; and
(B) Includes hospital-based laboratories;
(23) “Special analyst” means any person performing a singular or limited type of medical laboratory test or group of tests, such as, but not limited to, blood gases or pH tests, on human specimens, but who is not trained to perform the broad range of tests required of licensed medical laboratory personnel; and
(24) “Waived” means those laboratory tests systems cleared by the United States food and drug administration (FDA) for home use and those tests approved for waiver under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. § 263a).
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