Updating proficiency testing regulations

Bacteriology categories for which proficiency testing would be required, include: * Gram stain including bacterial morphology; direct bacterial antigen detection; * bacterial toxin detection; * antimicrobial susceptibility or resistance testing on select bacteria; * detection and identification of bacteria (including detection of growth or no growth in culture media or identification of bacteria to the highest level that the laboratory reports results on patient specimens). Public comments on the proposed rule suggested that this grouping of microbiology needs to provide further details to labs. Better understanding the required coverage for organism sample types, specimen type, and test methods would assist labs in enrolling in annual proficiency testing programs. Given that the U.S. Department of Health and Human Services already has authority to "resolve technical, administrative, and scientific problems" that may arise with proficiency testing program operations, the proposed rule appears to overreach.