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-.10 - Quality Control for Microbiology

Current through Rules and Regulations filed through June 27, 2024
Chemical or biological solutions, reagents, and antiserum
				  shall be tested and inspected as prescribed by the Department for reactivity
				  and deterioration. Discs and systems used in antibiotic susceptibility testing
				  are checked for deterioration and proper reactivity, using approved reference
				  organisms.
(a)
Bacteriology,
				Mycobacteriology and Mycology.
Staining material shall be tested for
				intended reactivity by weekly application to smears of microorganisms with
				predictable staining characteristics, with the exception of fluorochrome acid
				fast stains, which must be checked each day of use. Each batch of media shall
				be tested before or concurrently with use with selected organisms to confirm
				required growth characteristics selectivity, enrichment, and biochemical
				response. The laboratory may use commercial manufacturers' quality control
				checks of media if the laboratory has documentation to verify that the
				manufacturer meets the National Committee for Clinical Laboratory Standards
				(NCCLS) requirements for media quality control. Each day of use the laboratory
				must test direct antigen detection systems using positive and negative control
				organisms that evaluate both the extraction and reaction phases.
(b)
Parasitology.
A reference
				collection of slides, photographs, or gross specimens of identified parasites
				shall be available in the laboratory for the appropriate comparison with
				diagnostic specimens. A calibrated ocular micrometer shall be used for
				determining the size of ova and parasites, if size is a critical factor.
				Staining material shall be tested for intended reactivity, using a fecal sample
				control that will demonstrate staining characteristics, whenever a new lot
				number of reagent is opened or once a month, whichever comes first;
(c)
Virology.
1. Systems for the isolation of viruses and
				reagents for their identification shall be available to cover the entire range
				of viruses that are etiologically related to clinical diseases for which
				services are offered.
2. Records
				shall be maintained which reflect the systems used, and the reactions observed.
				In tests for the identification of viruses, controls shall be employed which
				will identify erroneous results.
3.
				Physical facilities and safety cabinets must be adequate and appropriate for
				the extent of testing offered.
4.
				There must be a written procedure in place and utilized by the laboratory for
				the proper disposal of infectious materials and biohazardous waste.
5. Host systems must be checked for
				sensitivity to viral agents and sterility.
6. Continuous cell lines must be checked for
				bacterial/fungal contamination as appropriate.
7. Storage requirements and expiration dates
				must be observed and recorded.
8.
				Diluents must be checked for sterility and pH.
9. Records must be kept of cell types,
				passage number, source, lot numbers and media used for growth and
				maintenance.
10. In tests for the
				identification of viruses, the laboratory must simultaneously culture
				uninoculated cells or cell substrate controls as a negative control to detect
				erroneous identification results.
11. Inoculated cultures must be checked for
				cytopathic effect at appropriate intervals.
12. Records must be kept of all quality
				control and quality assurance for as long as required under current federal
				regulations or not less than two years, whichever is more stringent.
13. If serodiagnostic tests for viral
				diseases are performed, requirements for quality control as specified for
				serology and immunology shall apply as listed at
				111-8-10-.09(4).