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First IQCP template set up for molecular tests

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4 microbiology templates revised

Valerie Neff Newitt

April 2022—Drawing on five years of experience and laboratory feedback, a collaborative team has revised the microbiology IQCP templates and created the first template for the quality control of a commercial cartridge-based molecular test system.

“The original [microbiology] templates are perfectly acceptable, and laboratories comfortable with using them can continue to do so,” says Elizabeth Palavecino, MD, professor of pathology and director of the clinical microbiology laboratory, Atrium Health Wake Forest Baptist Medical Center, and director of the Forsyth County Laboratory of Public Health, Winston-Salem, NC.

The new molecular testing template “is something people want and need,” she adds, noting the need became greater during the pandemic when reagents were in short supply. With an individualized quality control plan, “If your risk assessment is good, you can maybe use less QC,” she explains.

The format of the new molecular testing template will be familiar to users of other IQCP templates. “We wanted to use the same format so it would not seem too foreign, too different, too complicated,” says Dr. Palavecino, a member of a joint group of the CAP, American Society for Microbiology, and Clinical and Laboratory Standards Institute that developed the new template and revised the microbiology templates.

“It’s been five years since the templates were first introduced,” and the feedback has been positive, says Laura Filkins, PhD, D(ABMM), a member of the group and assistant professor of pathology at UT Southwestern and clinical microbiology laboratory director, Children’s Health, Dallas. “We didn’t change anything problematic or critical. We didn’t undo anything. Rather our effort was more a matter of embellishing the templates to make them even more user-friendly.”

The revised IQCP templates are for minimal inhibitory concentration-based antimicrobial susceptibility testing, disk diffusion AST, streamlined QC of a commercial identification system, and commercially prepared “CLSI-exempt” media. All are online at https://asm.​org/protocols/individualized-​quality-​control-plan-IQCP.

Sheldon Campbell, MD, PhD, professor of laboratory medicine, Yale School of Medicine, and associate chief of laboratory medicine at VA Connecticut Healthcare, and also a group member, says IQCPs ushered in a more comprehensive approach to the quality management of tests. “These templates are designed to give laboratories as much guidance as possible on how to do risk assessments, what to include, what things to think about for the different types of tests as they prepare to write up their individualized quality control plan.”

Dr. Campbell

In the “Ebola era,” he says, he had no idea how to do a risk assessment. “Those of us who bushwhacked through the wilderness are trying to send a map back to the folks who are getting ready to do the same. IQCPs have made us all come up to speed.”

During the pandemic, Dr. Campbell says, “more and more labs are bringing on molecular tests at a ferocious rate. They’re being put into labs that have never done molecular testing before.” For those labs, he says, “we tried to be as comprehensive as possible in our listing of areas where labs could look for risk and create examples of how to look for it.” Laboratories that already have an IQCP can use the new template to compare and to ask if they’ve left anything out or if they can “steal” any good ideas, he says, adding, “I’m all about stealing good ideas myself.”

There is a lot to consider when developing an IQCP for any test, Dr. Campbell says, but introducing a new molecular test brings with it additional considerations. “For example, contamination risks can be overlooked because that’s relatively unique to molecular test systems,” he says. “And there are things that result not necessarily in inaccuracy but in delays. Delayed reporting is something people sometimes do not think about in their risk assessment, but delayed testing can have clinical consequences too.” Without the type of guidance the template provides, he says, it would be easy to leave out important items.

Dr. Filkins

Dr. Filkins cautions that the template is not one-size-fits-all. “We highly recommend that laboratories modify the templates according to the tests they are running and their own environment, but the template offers a starting point and strong guidance.”

The microbiology IQCP templates and the new QC of Molecular Test System template begin with the five main areas of information needed to conduct risk assessment: regulatory and accreditation requirements, testing personnel, specimen, environment, and test system and reagents. “The major change we provided in the revisions is the inclusion of examples of the type of related data laboratories should collect for each of the five major sources of risk,” Dr. Filkins says.

Some things that were scattered throughout the original templates are now organized in the five subsections, which coordinate with a lab’s standard operating procedure. So it’s clear what information the laboratory needs to get and under what SOP the lab could find the information. “It goes with the flow of the lab, and I think that’s important,” Dr. Palavecino says.

Though the risk assessment is required, Dr. Filkins says, laboratories need not show within the IQCP what data they used to perform the assessment. “Data collection has to be performed, you do have to do it, but you don’t have to keep it in the same IQCP document.” The introductory page on all of the templates provides examples of metrics a laboratory can consider using when performing risk assessment. “Laboratories don’t have to pull the exact documents we are recommending,” Dr. Filkins says, “but they should be doing something equivalent that makes sense for their laboratories.”

Among the many questions laboratory staff have about IQCPs, the question Dr. Campbell hears most often is, What constitutes a test system? “That is still complicated for a lot of module-based test systems,” he says. “You’ve got a central computer connected to eight modules, each of which does a cartridge-based molecular test. How many test systems is that? Defining a test system turns out to be fairly complicated, and I’m not sure we have a complete answer. But one important point is that a test system includes not just the box and hardware, but the reagents, the software, the connection to the laboratory and electronic health records—all those kinds of things.”

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