As lab leaders consider consolidation and automation to drive new efficiencies, some have turned to the idea of moving virology testing to the high-volume chemistry environment. After all, many automated immunoanalyzers already closely resemble their molecular neighbors, while the advent of pre-analytic solutions and expanded menus has made it possible to perform a larger variety of tests on a single device.
Yet, this move challenges the traditional molecular lab model, where lab departments— molecular and chemistry—are most often individually siloed and budgeted. This raises the question: If virology testing moves to the chemistry environment, who oversees the testing? Do labs adhere to a traditional hierarchical model, where chemistry would own the tests, or do they apply a matrix model, where testing is shared between chemistry and molecular departments?
Below, lab leaders search for an answer.
With many lab leaders poised for disruption, many feel that moving virology to the lab may just be the next shake-up. So says Dr. Frederick Nolte, professor and vice chair for Laboratory Medicine and director of Clinical Labs and Molecular Pathology at the Medical University of South Carolina: "Because we've already adopted some reflexive testing algorithms where we go right from the immunoassay to the nucleic acid assay, the next step in thinking is, well, if we can do that, why not move the testing site close to where the immunoassay is being generated—and perhaps performed by the same people."
But as with any disruption to the molecular lab, lab leaders need to determine the best method to organize and direct the new system. If chemistry starts to perform virology testing, who owns it—molecular or chemistry?
In a traditional lab model, a hierarchical structure would reign. That is, testing would be overseen by the medical director of the department, which, in this case, would be chemistry. In other words, chemistry would oversee testing, quality assessment, and validation, and in all likelihood receive the commensurate reimbursement for those tests.
Yet, this might be a tough pill to swallow for molecular laboratorians. Dr. John Longshore, director of Molecular Pathology at Carolinas Pathology Group, Atrium Health observes, "Generally speaking, we [in the molecular lab] are generally a bit imperialistic about wanting to hold on to every test that we can perform. If it's a molecular technique, it is ours and we are responsible for it." This may be especially true with regard to chemistry, where there may be more risk for sample contamination.
As a result, in handing over virology to chemistry, it may be preferable for lab leaders to change the paradigm of traditional lab structure. Dr. Longshore, for one, advises a kind of partnership. "I think a model that works is one where you can work with other sections of the lab to bring them into the molecular arena, rather than trying to capture all the work in the molecular lab."
Dr. Nolte tends to agree with this assessment, but goes a step further, suggesting an alternative to the traditional hierarchical structure: the matrix model of management. "The only management that works [in this instance] is a matrix organizational structure, where you might have the same group of technologists performing chemistry, immunoassays, as well as molecular tests. But you, as the expert in that field, still have oversight."
He says that, under a matrix model, molecular tests would still feed into oversight to molecular lab directors for test validation—ensuring that molecular laboratorians "own" those tests, applying their expertise to sustain quality—but that overall management would be shared with other medical directors, such as from chemistry, as part of a management group.
This approach has several advantages. For one, molecular lab leaders can drive efficiencies by handing off viral load tests to chemistry, while still retaining critical ownership over the quality and consistency of tests. For another, lab directors can avoid the financial siloing problem: By partnering with chemistry, they can share reimbursement and avoid losing high-volume viral tests as a profit center. Finally, a working partnership between molecular and chemistry departments could help to foster increased communication, collaboration, and a renewed search for new efficiencies in both labs at large.
The shift of virology testing from the molecular lab to chemistry certainly presents a significant change, and challenge, for lab leaders. Of course, molecular lab leaders need to drive efficiencies of effort by partnering with other lab areas, but they also need to determine how tests will be managed, while retaining control over quality. In this case, a hierarchical management model offers the familiarity of routine, but may leave molecular labs with less reimbursement and quality oversight. On the other hand, a matrix model offers, potentially, the best of both worlds: shared financial and efficiency gains, plus the possibility of productive partnership. As always, lab leaders will need to work diligently to determine which structure best fits the unique particulars of their lab.
Contributing Lab Leader: Jim Ellis
Contributing Lab Leader: Keith Laughman, DBA