Increasingly, lab leaders are approaching the problem of growing testing volumes through platform consolidation. With the aid of expanded test menus, automated track lines, and pre-analytic solutions, lab leaders can accomplish more with less. Yet, with such high-throughput devices, many traditional virology tests are beginning to look a lot like their chemistry-based counterparts.
For this reason, a number of lab leaders are considering the logical next step: to move high-volume virology testing into the chemistry or immunoassay core lab, generating economies of effort and scale, while enabling molecular laboratorians to focus on more time-intensive testing. However, two major obstacles need to be overcome: ensuring sample integrity and breaking down the financial silos that can inhibit such change.
Here, lab leaders explore how molecular labs can approach this change.
Due to increasing workloads, it's become appealing for molecular leaders to hand off some degree of routine testing to other areas of the lab. Dr. John Longshore, director of Molecular Pathology at Carolinas Pathology Group, Atrium Health, says, "The problem is that the field is growing so quickly that we're going to overburden ourselves. This lends the potential to make routine mistakes, if we don't come up with ways to mitigate this risk, by turning over more routine testing to the other departments."
For many, the chemistry department is an obvious choice, where automated platforms increasingly resemble high-volume molecular counterparts. Yet, the chemistry environment can be rife with potential contaminants. A study in Clinical Chemistry, for example, found that background contamination with hepatitis B and C can be routine in total lab automation environments, which also suggests the possible presence of other blood-born pathogens like ebola and HIV in the chemistry lab.
Dr. Frederick Nolte, professor and vice chair for Laboratory Medicine and the director of Molecular Pathology at the Medical University of South Carolina, says that the challenge resides in sharing the same platforms, sample tubes, and receiving areas for both viral load and molecular tests. "Although they look similar and have total lab automation, many of the chemistry immunoanalyzers weren't designed with a molecular test in mind. So you have issues, in terms of sample to sample and environmental contamination."
What can lab leaders do to mitigate this threat? In many cases, the solution will depend on the particulars of the lab. Dr. Longshore—who houses molecular testing in the same Atrium facility as chemistry—takes a conservative approach. "We still require a pristine, virgin sample for all molecular tests. If something is a shared specimen, I really have to think long and hard about accepting it." Still, he believes that molecular and chemistry will need to learn to share more samples, and that solutions are possible.
Dr. Nolte, meanwhile, recommends that lab leaders take stock in the unique potential sources of contamination for their lab. "Look where there's an opportunity to introduce [contamination] into specimens—for example, in our chemistry lab, where the tubes are percolating on an automation lab without any caps on them." He says that when lab leaders carefully assess and understand their risks, they can then build robust safeguards to mitigate the possibility of contamination. He also recommends cross- training medical technologists who perform immunoassays and traditional biochemical tests on molecular tests—to both ensure their understanding of risks and guarantee that they can follow guidelines appropriately.
"I think it's possible [to mitigate these risks]. I really do," he says.
Of course, another challenge of moving viral tests to chemistry is that, in many cases, molecular labs depend on high-volume tests for revenue. As a result, lab leaders must determine how to convince administrators to either de-silo their operations or retain management of virology, after it moves to chemistry. In both these cases, the goal is simple, explains Dr. Pam Ward associate professor of Clinical Pathology and scientific director of Molecular Pathology at the Keck School of Medicine of UCS.
"What administrators look at most carefully are dollars. If you can show that you've saved money from changing the paradigm, then you are saving X amount of dollars for the health system." In other words, the key to change management is to clearly demonstrate the overall economy of effort and scale achieved by consolidating virology with chemistry.
Dr. Nolte agrees. "At the end of the day, it's the bottom line for all the laboratories that matters. That means holding section directors and managers accountable for that individual budget piece—remembering that it is largely arbitrary and can be changed."
For many lab leaders, the consolidation of high-volume virology testing into the chemistry lab is a logical next step and an appealing way to manage growing workloads. To accomplish this, however, lab leaders must carefully assess the risk involved, before demonstrating to administrators that the move helps to achieve more with less.
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