CMS SOM App. C, Tag D5519

(b) For antifungal susceptibility tests, the laboratory must check each batch of

media and each lot number and shipment of antifungal agent(s) before, or

concurrent with, initial use, using an appropriate control organism(s).

(b)(1) The laboratory must establish limits for acceptable control results.

Probes §493.1263(b)(1)

Which control strains are used and how did the laboratory establish acceptable control

limits for susceptibility tests?

(b)(2) Each day tests are performed, the laboratory must use the appropriate

control organism(s) to check the procedure.

Probes §493.1263(b)(2)

Are quality control samples tested at the same time specimens are tested?

(b)(3) The results for the control organism(s) must be within established limits

before reporting patient results.

§493.1263(c) The laboratory must document all control procedures performed, as

specified in this section.

Interpretive Guidelines §493.1263(c)

QC records should include lot numbers, date prepared/opened, expiration dates, the actual

measurements, reactions, and/or observations and demonstrate that controls were tested

and acceptable when shipments of reagents, discs, stains, or antisera for identification

systems were opened or when the laboratory prepared these materials.