AST and safety at core of microbiology checklist changes

Clinicians need to know this information to make good therapeutic decisions, Dr. Rauch says, “and to manage that situation from a public health perspective.

“I don’t necessarily mean large public health situations, but even just infection prevention within a hospital. We are bumping up the performance of laboratory testing to make it as clinically relevant and actionable as possible. That’s the intent,” she says.

In the same section is MIC.21950 Inconsistent Antimicrobial Results, which requires a written policy to address unusual or inconsistent antimicrobial testing results and now also requires action be taken to address them. Those actions may include consulting with a medical laboratory director, repeating antimicrobial susceptibility testing by the same or a different method, confirming isolate identification, or referring the isolate to a public health laboratory for confirmation. While results are being confirmed, a lab must consider whether it should inform the treating clinician that the AST results are under investigation.

Says Dr. Campbell: “We have a fairly good understanding of the usual resistance pattern of a lot of organisms. When there’s an exception to that pattern, it tells you there’s something new and interesting and possibly horrible in the resistance world, or, more commonly, that you’ve misidentified the organism, you’ve got a mix, or any one of several technical issues.”

Dr. Wojewoda says the requirement is intended to make sure that the susceptibility testing results laboratories get by whatever method they use correspond with the organism they think they have. “I teach my residents that there is no Klebsiella susceptible to ampicillin. If you believe your organism is a Klebsiella and your susceptibility test system says it is susceptible to ampicillin, you need to make sure the bug you’re dealing with truly is a Klebsiella, or you need to change that susceptible result to resistant because we know that patients clinically will fail treatment if they’re treated with ampicillin.”

Dr. Rauch notes that support systems such as expert computer algorithms and software can help to flag results that might be “weird, new, or implausible.”

“We’re asking laboratories to think about ways they can identify things that might require confirmatory testing,” she says, “and to find any results that are erroneous or represent something new and significant as a resistance marker that they would need to communicate to a lot of people.”

Also in the bacteriology section is MIC.21240 Media QC—Purchased/Acquired, which has been revised to say that laboratories that supply uninoculated media to referring laboratories are responsible for the quality control of the media and must provide records or certification of media QC with every shipment.

“Somebody has to be responsible for quality control when materials are transferred,” Dr. Campbell says. “In the past a supplier might have expected the receiving lab to take that role. But this makes it explicit: The supplying lab must be responsible, and quality control records must be available to the receiving lab.” Among the evidence of compliance are records of reports of media problems/defects provided to manufacturers or referral labs supplying the media.

MIC.11035 Inspection of Media Shipments previously required that a lab maintain records showing it examined each shipment of purchased or otherwise acquired media for breakage, contamination, appearance, and evidence of freezing or overheating. It now requires, in addition, that any such problems be recorded and reported to the manufacturer. “We’ve closed a circle,” Dr. Campbell says. “It’s not enough to just examine the media. Your procedures and your records must define what you do when you find something.”

Requirements in the new dedicated section on safety apply to all areas of the microbiology laboratory, Dr. Wojewoda says. “We made it more global, and we’ve given inspectors ways to go about inspecting laboratory safety across the entire microbiology lab.”

Among the guiding directives for inspectors is one that instructs them to check a laboratory’s infectious waste disposal policy. Another calls for observing use of personal protective equipment. “PPE has always been important, but COVID has made us even more aware of its importance,” Dr. Campbell says.

MIC.19035 Safe Specimen Processing requires written policies and procedures for the safe handling and processing of specimens and now has been revised to say: “including those suspected to contain highly infectious pathogens.”

“We are reminded once again that there is a whole range of pathogens out there,” Dr. Campbell says. “Some are old hazards and some are new. We wanted to point out that labs need specific policies and procedures for a sample that is even suspected of having a highly contagious pathogen.”

Though a note with examples of such pathogens now includes SARS-CoV-2, Dr. Campbell says this requirement was driven by past experience with Ebola and the high risk that handling Ebola specimens presented to laboratory workers. “This requirement doesn’t order labs to handle specimens a specific way. It just says they must create a written plan of their own design.”

In the laboratory general checklist, the section titled “Blood culture specimen collection for referral only” applies to laboratories that perform only blood culture collection using media provided and quality controlled by another laboratory and not other types of microbiology testing requiring the microbiology checklist. It also says the microbiology checklist must be used to inspect laboratories that order blood culture media directly from the manufacturer or supplier and/or labs that perform any level of blood culture testing.

“There are some labs that just collect blood cultures, then send them on to another lab to be incubated and for a full workup if needed. In the past these labs were getting the full microbiology checklist, and that was overkill for them,” Dr. Wojewoda explains. The four requirements in this section are the same as before, but their placement within the laboratory general checklist has changed, affecting these laboratories in particular. For other laboratories that perform additional microbiology testing, the requirements continue to be in the microbiology checklist.

Dr. Campbell says this new section uses checklist customization. “Some labs are collecting blood cultures and sending them off; that’s all the microbiology they do. So this pulls out those items for those labs. It’s much more streamlined for them.”

“What we’ve done with these revisions,” Dr. Wojewoda says in summary, “is improve practice, especially in the realm of antimicrobial susceptibility testing where we’ve asked more of labs in terms of keeping up with changing practices; improve laboratory safety, with increased emphasis on dangerous microbes; and streamline and clarify checklist requirements, which in the end makes compliance easier for labs.”

Valerie Neff Newitt is a writer in Audubon, Pa.