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 June 27, 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. §
										31-22-1
et
				  seq.