Title XXVI, Occupations and Professions

Application for a medical laboratory license shall be made under oath by the director of the medical laboratory. The license shall be issued only for the performance of those medical laboratory procedures which the particular laboratory, by virtue of the educational and experienc…

A medical laboratory license shall specify, on the face thereof, the names of the director and the owner, 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 pro…

A medical laboratory license shall be valid for the calendar year for which it is issued. The cabinet shall promulgate administrative regulations to establish fees, not to exceed the administrative costs to the program, for the initial application for a license and license renewa…

transferable. A license to operate a medical laboratory shall be issued to the director for the purposes stated in the application, and he shall be responsible to the cabinet for the maintenance and conduct thereof including any violations of the provisions of this chapter and th…

(1) Except as otherwise provided in subsections (2) and (3) of this section, the director of a medical laboratory shall be a physician licensed to practice medicine in Kentucky. (2) The director of a medical laboratory may be the holder of an earned doctoral degree, with a chemic…

The cabinet may prescribe minimal qualifications for medical laboratory personnel including but not limited to microbiology, serology, chemistry, hematology, immunohematology, biophysics, cytology, or pathology.

No person shall construct, acquire, maintain or operate a school for training medical laboratory personnel and/or medical laboratory trainees in this state unless approval has first been obtained from the cabinet. Approval shall be contingent upon presentation of satisfactory evi…

The cabinet is authorized to inspect the premises and operations of all medical laboratories for the purpose of studying and evaluating the operation, supervision, and procedures of such facilities and to determine their effect upon the health and safety of the people of this sta…

The cabinet may require reporting by medical laboratories of selected test results for the protection of the public health. The cabinet may furnish forms for this purpose. Such reports shall not be construed as constituting a diagnosis nor shall any medical laboratory or medical …

The cabinet may require medical laboratory directors to submit such reports concerning medical laboratory operations as may be reasonably necessary to administer this chapter, such as changes of personnel, services or program.

persons -- Transmission of medical laboratory results -- Compliance with HIPAA -- Contents of lab report. (1) A medical laboratory shall examine human specimens only at the request of a licensed physician, podiatrist, dentist, or other person authorized by law to use the findings…

(1) Notwithstanding any other provision of law to the contrary, except as provided by subsection (2) of this section, a health care provider requesting that a medical laboratory test for a patient is performed shall not engage in information blocking as described in 42 U.S.C. sec…

Only a licensed physician, dentist or other person authorized by law shall manipulate a patient for the collection of specimens, except that qualified personnel authorized by him may collect human blood or materials for smears or cultures.

Shipment through mails regulated. (1) No person shall represent, or maintain an office or specimen collection station or other facility for the representation of any medical laboratory situated in this state unless the medical laboratory so represented is licensed pursuant to the…

(1) Records involving medical laboratory services and copies of reports of laboratory tests shall be kept for the period of time and in a manner prescribed by regulation of the secretary. They shall be made available to representatives of the cabinet for inspection during regular…

A medical laboratory license may be denied, revoked, suspended, limited, annulled, or renewal thereof denied for any of the following reasons: (1) Making false statements on an application for medical laboratory license or any other documents required by the cabinet. (2) Permitti…

order -- Appeal. (1) In every proceeding for suspension or revocation of a license, the cabinet shall afford the medical laboratory director the opportunity for an administrative hearing to be conducted in accordance with KRS Chapter 13B. A license may be temporarily suspended th…

The secretary shall adopt reasonable rules and regulations to effectuate the purposes and provisions of this chapter, which may include, but not be limited to, the following subject matters: licensure of medical laboratories; qualifications of medical laboratory personnel; standa…

The secretary for health and family services shall appoint an advisory committee to advise the cabinet in the fulfillment of its responsibilities under this chapter. The committee shall be composed of nine (9) appointed members. The secretary for health and family services or his…

All fees collected under the provisions of this chapter shall be credited to a trust and agency fund to be used by the cabinet for defraying the costs of administering this chapter.

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. (2) Conduct, maintain, or operate a nonexempt medical laboratory unless such la…

(1) The operation or maintenance of an unlicensed medical laboratory in violation of this chapter is declared a nuisance, inimical to the public health, safety and welfare. The cabinet may, in addition to other remedies herein provided, bring an action for an injunction to restra…

KRS 333.010 to 333.260 and 333.990 may be cited as the "Kentucky Medical Laboratory Act."

The performance of any of the acts specified in KRS 333.240 or for violation of any other provision of this chapter or of any rules and regulations of the board adopted hereunder shall constitute a misdemeanor punishable, upon conviction, by a fine of not less than $300 nor more …