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-.19 - Quality Control for Cytogenetics

Current through Rules and Regulations filed through June 27, 2024
(1) Each laboratory performing cytogenetics
				procedures shall engage the services of a sufficient number of testing
				personnel who meet the requirements as noted in Rule
				111-8-10-.06. In addition, the
				laboratory must document the competency of testing personnel in the areas of
				collection, handling, preparation and processing of various specimens,
				appropriate culture techniques for specimens submitted, proper techniques for
				setting up cell cultures and harvesting specimens, proper techniques of
				chromosome banding and staining, maintenance and use of microscopes,
				photographic and computer-generated imaging techniques and equipment,
				chromosome analysis including knowledge of normal and abnormal morphology,
				general laboratory skills, quality control, and understanding of general
				principles of genetics.
(2) Each
				cytogenetics laboratory must comply, at a minimum, with ma nfacturers'
				instructions except where applicable regulations are more stringent, when using
				reagents and equipment and must document all quality control activities.
(a) The laboratory must define and follow
				specific criteria for receiving specimens and for handling unacceptable
				specimens.
(b) The laboratory must
				establish and follow a maintenance schedule and must document routine
				maintenance and function checks on all instruments. Microscopes must have a
				sufficiently high resolution for examination of slides. The hoods used for
				processing and handling cultures must be designed to keep contaminants out,
				checked periodically to ensure that the filters are functioning properly and
				that the airflow meets specifications and protect employees.
(c) The laboratory must perform an acceptable
				quality control performance check on routine and fluorescent stains (the method
				must check the timing that is critical to the staining process). Corrective
				action must be documented, if staining time has to be adjusted. Reagents
				(purchased, made in-house or aliquoted) must be properly labeled, and include
				content and quantity, concentration or titer, storage requirements, date
				prepared or received, date placed in service and expiration date.
(d) For in-house culture media, an acceptable
				method of checking the pH, sterility, contamination and ability to support
				growth must be in place. The sterility of each lot or shipment of commercial
				media must be checked when received.
(e) The laboratory must establish procedures
				and follow the appropriate incubation period for cell cultures to achieve
				active cell division. Incubation time may vary for each diagnostic area. There
				must be a monitoring system in place to detect power failure which may affect
				the incubation phase.
(f) The
				laboratory must define and document chromosome analysis failure rates, maintain
				records of causes of failures and investigate cultures that failed.
(g) The laboratory must establish (based on
				standardized methods) the minimum number of cells examined for X and Y
				chromatin counts, fragile X, complete metaphases or other applicable analysis
				performed.
(h) Critical limits must
				be established for appropriate tests and records must identify the appropriate
				person to be notified if results do not fall within established
				limits.