105 CMR, § 180.395 - Standard - Microbiology: Quality Control

Chemical and biological solutions, reagents, and antisera shall be tested and inspected as specified below for reactivity and deterioration using positive and negative control organisms. The following requirements apply to the specialties of Bacteriology, Mycology, Parasitology, and Virology:

(A) Materials which shall be tested and inspected on each day of use include:

(1) Media and discs used for antibiotic susceptibility testing;

(2) Reagents and solutions used in the performance of conventional biochemical testing;

(3) Stains (exception - Gram Stain).

(B) Materials which shall be tested and inspected each week of use and when a new vial or container is opened include:

(1) Antibiotic discs (exception: antibiotic susceptibility discs);

(2) Chemical strips;

(3) Gram Stain materials.

(C) Materials which shall be tested and inspected each month of use and when a new vial or container is opened include:

Antisera.

(D) Materials which shall be tested and inspected when each new batch or shipment is received include:

(1) Tube and plate media;

(2) Gram negative identification sets.

(E) Bacteriology and Mycology. Staining materials shall be tested for intended reactivity by concurrent application to smears of micro-organisms with predictable staining characteristics. Each batch of medium shall be tested before or concurrently with use with selected organisms to confirm required growth characteristics, selectivity, enrichment, and biochemical response.

(F) Parasitology. A reference collection of slides, photographs, or gross specimens of identified parasites shall be available and used in the laboratory for 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.

(G) Virology. Systems for the isolation of viruses and reagents for the identification of viruses shall be available to cover the viruses for which services are offered. 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. If serodiagnostic tests for virus diseases are performed, requirements for quality control as specified for serology shall apply.

Notes

105 CMR, § 180.395