Compilation of Rules and Regulations of the State of Georgia › Department 111 - RULES OF DEPARTMENT OF COMMUNITY HEALTH › Chapter 111-8 - HEALTHCARE FACILITY REGULATION › Subject 111-8-10 - LICENSURE OF CLINICAL LABORATORIES › Rule 111-8-10-.04 - License

Current through Rules and Regulations filed through June 27, 2024
(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; or
2. 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.