Rule 111-8-10-.04 - License(1) Clinical Laboratory License. (a) No clinical laboratory shall be operated without a license issued pursuant to these rules and regulations and without a licensed director. All laboratory activities, which are not specifically exempted by these regulations, must be performed in a license laboratory. Provided, however, a facility or part of a facility in which laboratory testing is done may qualify for exemption from personnel requirements when only specific tests or techniques, designated by the Department and used for screening and monitoring purposes only, are performed, and the facility or part of the facility is under the supervision of the laboratory as outlined in Rule 111-8-10-.16.(b) A license shall be issued by the Department to a clinical laboratory after all requirements for licensure are met.(c) A provisional license may be issued as an authorization to operate a clinical laboratory for a limited and specified period of time under the following conditions: 1. After a review of an application and on-site inspection of a new laboratory has indicated that the laboratory has the potential to meet required standards and appears to be in substantial compliance with the requirements of these rules and regulations; or2. An inspection or review of a licensed laboratory reveals only correctable deficiencies for which an acceptable plan of correction has been provided to Licensure of Clinical Laboratories Chapter 111-8-10 the Department and where the deficiencies do not constitute imminent hazards to patients or to laboratory personnel.(d) A license shall authorize the performance of one or more categories, subcategories and/or test procedures and shall be valid for one year from the date of issue unless sooner canceled, suspended or revoked. Renewal of a license is subject to continued conformance with all rules and regulations.(e) A license shall specify the names of the owner and director, categories and subcategories of tests, and the location of the laboratory. The laboratory license must be displayed at all times in view of the public.(f) A license shall be valid only for the clinical laboratory (as defined at 111-8-10-.03(c)) at the stated location and shall not be subject of sale or transfer to any premises other than those for which it was issued. Should the laboratory change its location, or ownership, a new application shall be made.(g) Laboratory licenses shall be maintained current and changes in categories/subcatogories of tests or off site locations shall not be implemented without prior notification to and approval by the Department.(h) Specimen collection stations which have a parent clinical laboratory which is licensed by the State of Georgia may be considered by the Department to be a part of that laboratory; but subject to all other applicable regulations.(2)Director's License.(a) A director's license shall be issued by the Department to persons meeting the requirements stated in these rules and regulations. Applications for licensure or renewal as a director shall be made on a form provided by the Department accompanied by the non-refundable fee, and provide pertinent information as deemed necessary by the Department.(b) The director's license shall be maintained current and changes in the required information shall be reported to the Department when they occur. Application shall be made and approved by the Department prior to assumption of duties as a laboratory director.(c) Any licensed laboratory director who is convicted, pleads guilty or nolo contendere or receives first offender treatment under the laws of this state, the United States, or any other state of any criminal offense involving the manufacture, distribution, trafficking, sale, or possession of a controlled substance or marijuana shall notify the Department of the conviction within ten days following the conviction, plea or first offender treatment.Ga. Comp. R. & Regs. R. 111-8-10-.04
O.C.G.A. §§ 16-13-111 and 31-22-1et seq.
Original Rule entitled "License" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.