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-.09 - General Quality Control Requirements
Current through Rules and Regulations filed through September 23, 2024
Each laboratory shall establish and follow written policies and procedures for a quality assurance program, comprehensive in scope and specific to that laboratory. The program shall monitor and evaluate the ongoing and overall quality of the total testing process from specimen collection to reporting of test results. The program shall identify and correct problems, assure the accurate, reliable and prompt reporting of test results and assure adequacy and competency of laboratory staff. Written procedures shall be revised when evaluation results indicate the need. There must be documentation of the ongoing quality assurance program as well as corrective action taken when necessary. The laboratory director is responsible for ensuring that the following quality controls are employed for all clinical testing authorized under the laboratory's license:
(a) Preventive maintenance, periodic inspection or testing for proper operation of equipment and instruments, based on but not limited to manufacturers' instructions. The laboratory must confirm the effectiveness of its preventive maintenance program;
(b) Each quantitative method shall be validated prior to placing into routine use. Such validation shall include reportable range, sensitivity, specificity, accuracy and precision. Documentation of validation shall be maintained for the period the method is used, or for at least two years, whichever is longer;
(c) Evaluation of reagents and volumetric equipment;
(d) Maintenance of documentation verifying that test systems perform according to laboratory specification; such documentation must be available to the authorized persons ordering or receiving test results, and to the Department; the laboratory must establish its reference range for each method before reporting patient test results;
(e) Establishment and employment of policies/procedures for remedial action to be taken in response to quality control outside acceptable limits, equipment or methodology performance outside established operating limits, test results outside acceptable limits, tests not performed within laboratory established time frames, proficiency test results outside acceptable limits or errors detected in reported patient results;
(f) Adequacy of space, ventilation, facilities, equipment, instruments, and methods of performance of the procedures or categories of procedures for which a license application is filed or granted; proper lighting for accuracy and precision; convenient location of essential utilities; monitoring of temperature controlled spaces and equipment to assure proper performance of equipment and storage of specimens, tissues, reagents and supplies; the evaluation of analytical measuring devices, with respect to all critical operating characteristics, and the laboratory shall not report test results unless such operating characteristics are within defined acceptable ranges;
(g) Labeling of all reagents and solutions to indicate identity, and when significant, titer, strength or concentration, recommended storage and preparation or expiration date, and other pertinent information. Material of substandard reactivity, expired, or deteriorated materials may not be used;
(h) Availability at all times, in the immediate bench area of personnel engaged in examining specimens and performing related procedures within a category, of laboratory manuals or other complete written descriptions and instructions (properly designated and dated to reflect an initial and periodic review by the current director) relating to the current analytical methods, specimen processing procedures, reagents, control and calibration procedures, microscopic examinations, remedial action procedures, limitations in methodologies, pertinent literature references and the date each procedure was placed into use. Textbooks may be used as supplements to such written descriptions but may not be used in lieu thereof;
(i) Written approval by the director of any and all changes in laboratory procedures; a copy of each procedure must be retained for two years after the procedure has been discontinued;
(j) Maintenance and availability to laboratory personnel, and to the Department, of records, reflecting dates, and where appropriate, the nature of inspection, validation, remedial action, monitoring, evaluation, and alternative test methods;
(k) Written materials designed to provide instruction for proper collection, labeling, preservation and transportation of specimens to assure accurate results suitable for clinical interpretation.
O.C.G.A. § 31-22-1et seq.
