No person shall:
(1) Operate, maintain or direct a medical laboratory, as herein defined, which is not exempt under KRS § 333.040, unless a medical laboratory license has been obtained from the cabinet.

Terms Used In Kentucky Statutes 333.240

  • Cabinet: means the Cabinet for Health and Family Services. See Kentucky Statutes 333.020
  • Contract: A legal written agreement that becomes binding when signed.
  • Medical laboratory: means any institution, building, place, or any other facility in which operations and procedures for the microbiological, serological, chemical, hematological, immunohematological, biophysical, cytological, pathological, or other methods of examination of tissues including blood, secretions, and excretions of the human body are performed to obtain information in diagnosing, preventing, or treating disease, or in which the results of any examination, determination, or test are used as a basis for health advice. See Kentucky Statutes 333.020
  • Person: means any individual, firm, partnership, association, corporation, municipality, political subdivision, or any other entity whether organized for profit or not. See Kentucky Statutes 333.020
  • Violate: includes failure to comply with. See Kentucky Statutes 446.010

(2) Conduct, maintain, or operate a nonexempt medical laboratory unless such laboratory is under the direction of an individual authorized by KRS § 333.090.
(3) Accept specimens for tests from and make reports to persons who are not legally qualified or authorized to submit specimens to medical laboratories and to receive such reports. However, this does not prohibit the referral of specimens from one licensed medical laboratory to another laboratory licensed or approved under this chapter providing the report indicated clearly the medical laboratory performing the test and the name of the director of such medical laboratory.
(4) Either personally or through an agent, solicit referral of specimens to his or any other medical laboratory or contract to perform medical laboratory examinations of specimens in a manner which offers or implies an offer or rebates to a person or persons submitting specimens, other fee-splitting inducements, participation in any fee-splitting arrangements, or other unearned remuneration.
(5) Violate or aid and abet in the violation of any provision of this chapter or the rules or regulations promulgated hereunder.
History: Created 1968 Ky. Acts ch. 180, sec. 25.