Current through Rules and Regulations filed through September 23, 2024
(1) The administration and enforcement of these rules and regulations shall be in accordance with Chapters 2, 5 and 22 of Title 31 of the Official Code of Georgia Annotated and Chapter 13 of Title 50 of the Official Code of Georgia Annotated and the Rules and Regulations General Licensing and Enforcement Requirements, Chapter 111-8-25.
(2) A Clinical Laboratory and/or Clinical Laboratory Director License may be denied, revoked, suspended, limited or renewal denied for:
(a) Making false statements of material information on an application for a license or any other documents required by the Department;
(b) Permitting unauthorized persons to perform technical procedures or to issue or sign reports;
(c) Demonstrating incompetence in the performance or reporting of clinical laboratory examination and procedures;
(d) Performing a test for or rendering a report to a person not authorized by law to receive such services;
(e) Referring a specimen for examination to a clinical laboratory in this state which has not been licensed or exempted under Chapter 22 of Title 31 of the Official Code of Georgia Annotated or, if not in this state, certified under all applicable federal law and associated rules and regulations;
(f) Making a report on clinical laboratory work actually performed in another clinical laboratory without designating the director and the name and address of the clinical laboratory in which the test was performed.
(g) Lending the use of the name of the licensed clinical laboratory or its personnel to an unlicensed clinical laboratory;
(h) Violating or aiding in the violation of any provision of Chapter 22 of Title 31 of the Official Code of Georgia Annotated, or these rules and regulations;
(i) Violating any other provisions of law applicable to the proper operation of a clinical laboratory.
(3) Upon being notified of a conviction, plea, or first offender treatment of a licensed laboratory director involving the manufacture, distribution, trafficking, sale, or possession of a controlled substance or marijuana, the Department shall suspend or revoke the license of such individual as follows:
(a) Upon the first conviction, the licensed individual shall have his or her license to direct a clinical laboratory suspended for a period of not less than three months, provided, however, that in the case of a first conviction, plea, or first offender treatment for a misdemeanor the Department shall be authorized to impose a lesser sanction or no sanction upon the licensed individual, and
(b) Upon the second or subsequent conviction, the licensed individual shall have his or her license to direct a clinical laboratory revoked. The failure of a licensed laboratory director to notify the Department of a conviction as required in subsection C of Rule 111-8-10-.04(2) shall be considered grounds for revocation of his or her license to direct a clinical laboratory.
(c) A licensed laboratory director sanctioned under the foregoing subsections (a) or (b) may be entitled to reinstatement of his or her license to direct a clinical laboratory upon successful completion of a drug abuse treatment and education program approved by the Department.
(4) The operation or maintenance of an unlicensed clinical laboratory in violation of Chapter 22 of Title 31 of the Official Code of Georgia Annotated and these rules may be declared a nuisance, inimical to the public health, welfare, and safety. The Commissioner may bring an action for an injunction to restrain such violation or to enjoin the future operation or maintenance of any such clinical laboratory until compliance with Chapter 22 of Title 31 of the Official Code of Georgia Annotated and these rules has been demonstrated to the satisfaction of the Department. (5) Any person who violates any provision of Chapter 22 of Title 31 of the Official Code of Georgia Annotated or any of the rules and regulations promulgated thereto shall be guilty of a misdemeanor.
O.C.G.A. §§
16-13-110et seq., 31-2-8 and 31-22-1et seq.
