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

Universal Citation: GA Rules and Regs r 111-8-10-.10

Current through Rules and Regulations filed through September 23, 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).

O.C.G.A. § 31-22-1et seq.

Disclaimer: These regulations may not be the most recent version. Georgia may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.