Also in the mycology section of the microbiology checklist is MIC.42025 Cryptococcal Antigen, which has been revised and says if cryptococcal antigen-detection methods are used on CSF, backup fungal cultures must be performed on all CSF specimens submitted for diagnosis, a change from the previous requirement to perform backup culture only on cryptococcal antigen-positive specimens.
“It’s an attempt to capture more pathogens causing an infection,” Dr. Rauch says.
It doesn’t apply to a reference laboratory that performs the cryptococcal antigen test only without insight into what testing may have been performed at the referring laboratory. It is the latter that must ensure that the CSF specimen includes both cryptococcal antigen and backup culture results. “The responsibility for the backup culture is that of whoever owns that specimen,” she says, noting the laboratory will have to show during an inspection the records of backup CSF cultures performed onsite or in another location.
Not new to the microbiology checklist but worth noting owing to their importance to accuracy and safety are MIC.11380 Antimicrobial Susceptibility Test Interpretation Criteria and MIC.11385 Current Antimicrobial Susceptibility Test Breakpoints. The first of the two is known as the “Know your breakpoints” requirement, Dr. Rauch says.
“A lot of laboratories were doing susceptibility testing, reporting it, and letting the clinicians use that information to care for patients, but they never knew what breakpoints were being used to interpret the test results,” she explains. “The criteria were hidden in a big black box of an instrument.” Now, the MIC.11380 requirement has been regrouped and tweaked but remains unchanged, she says.
She sees MIC.11385 as a companion and calls it the “Know that the breakpoints are current” requirement. “We don’t want a breakpoint from 15 years ago, one that the organisms have evolved far faster than, and for which we never changed any of the settings in our testing. It would be a source of medical error,” Dr. Rauch notes.
In addition, standardized breakpoints are important. “We don’t want a hospital down the street one way using one set of criteria or not knowing what criteria it is using and relying on the instrument to spit it out, and another hospital in the other direction using different criteria. Wherever the patient goes, we want the correct criteria.”
Overall, Dr. Rauch predicts that laboratories will find the reorganization of the checklist to be helpful.
“All of these things together add up to pay attention to how you’re testing, know your breakpoints and use current breakpoints, decide what you’re going to report using your partnership with other people, and be prepared to get more results, in your lab or sent out, when the resistance of the organism requires it.”
“All of that existed before,” she says. “They’ve just been tweaked and moved to where you will see them together.” And though such rearrangements of requirements may be perceived as “bureaucratic” and unnecessary, Dr. Rauch adds, “It’s always in response to a real situation, with the goal of making sure labs don’t miss it and they understand what it is and why.”
Valerie Neff Newitt is a writer in Audubon, Pa.