Ga. Comp. R. & Regs. R. 111-8-10-.19 - Quality Control for Cytogenetics

(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.

(3) The laboratory must maintain records that indicate the media used, reactions observed, number of chromosomes counted for each metaphase spread, quality of banding, and resolution to support the final results and number of karyotypes for each individual. Records must also be maintained of confirmatory testing on all atypical results, of at least two cells karotyped for each use, and two cultures for each specimen type.

(4) The laboratory must establish guidelines, based on appropriate standards for setting time limits on signing out final reports. Preliminary reports must be submitted within a reasonable length of time as established by the laboratory. Laboratory reports must include type of banding used, number of cells counted and analyzed microscopically, number of cells from which photographic or computerized karotypes were prepared, band resolution, preliminary report results, a narrative report of clinical pathology interpretation of the laboratory findings, diagnosis and identification of testing personnel. The current International System of Human Cytogenetic Nomenclature (ISCN) or other standard nomenclature recognized industrywide, must be used correctly in the final report. The results of tests performed must be reviewed and signed out by the director.

Notes

Ga. Comp. R. & Regs. R. 111-8-10-.19

O.C.G.A. § 31-22-1et seq.

Original Rule entitled "Quality Control for Cytogenetics" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.