US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1261-1265: Meet the microbiology specialty control requirements: reactivity checks of beta-lactamase, Gram stain, antisera and mycobacterial reagents at the stated frequencies; control organisms for each batch, lot and shipment of susceptibility media and agents with results within established limits before reporting; lactophenol cotton blue checks; a parasitology reference collection, calibrated ocular micrometer and monthly permanent stain checks; and uninoculated cell culture negative controls in virology

What does 1261-1265 require?

In bacteriology the laboratory must check for positive and negative reactivity using control organisms each day of use for beta-lactamase methods other than Cefinase, each week of use for Gram stains, and when each batch, lot number and shipment of antisera is prepared or opened and every six months thereafter; for antimicrobial susceptibility tests it must check each batch of media and each lot and shipment of antimicrobial agents before or with first use using approved control organisms, use the appropriate control organisms each day tests are performed, and confirm that zone sizes or minimum inhibitory concentrations for the controls are within established limits before reporting patient results. In mycobacteriology all identification reagents and procedures must be checked each day of use with a positive and a negative acid-fast organism, and antimycobacterial susceptibility media and agents checked per batch, lot and shipment with established limits and weekly control organisms. In mycology each batch, lot and shipment of lactophenol cotton blue must be checked with a control organism, and antifungal susceptibility media and agents per batch, lot and shipment with daily control organisms within established limits. In parasitology the laboratory must keep a reference collection of slides or photographs and gross specimens for comparison, calibrate and use the ocular micrometer where size is critical, and check permanent stains each month of use with a fecal control. In virology cell culture isolation or identification must include a simultaneously incubated cell substrate or uninoculated negative control. All control procedures must be documented.