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-.30 - Inspection and Plans of Correction

(1) Employees and agents of the Department shall have the right of entry into the premises of the laboratory during all hours of operation and full access to all records, reports and documents relevant to the licensure status of the laboratory as determined by the Department.

(2) Licensed laboratories shall submit to inspection by CMS or CMS agents as a condition of licensure, and failure to submit to such inspection shall constitute grounds for suspension or denial of the State license.

(3) A laboratory subject to CMS inspection is authorized and required by the Department to release to CMS or CMS agents all records and information required by CMS in the course of the inspection.

(4) The Department shall make periodic inspections of every clinical laboratory, at its discretion. The frequency of inspection shall take into consideration the compliance record of the laboratories, e.g., the laboratory personnel, proficiency testing performance, and the number or seriousness of deficiencies reported on or since the last on-site inspection.

(5) The director or the laboratory supervisor in charge of the laboratory in the director's absence shall be present during each inspection of the laboratory. In the case of hospital laboratories, the hospital administrator or the administrator's designee shall be available for interview at the opening and close of inspection.

(6) None of the inspections performed by the Department nor any reports generated by the Department shall relieve the licensee from its duty to maintain the safety of its equipment, the work place, or to ensure safe and accurate laboratory testing.

(7) Plan of Correction. If as a result of an inspection, violations of these licensing rules are identified; the laboratory will be given a written report of the inspection which identifies the rules violated. The laboratory shall submit to the Department a written plan of correction in response to the report of inspection, which states what the laboratory will do, and when, to correct each of the violations identified. The laboratory may offer an explanation or dispute the findings or violations in the written plan of correction, so long as an acceptable plan of correction is submitted within ten days of the facility's receipt of the written report of inspection. The laboratory shall comply with its plan of correction.