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Would molecular diagnostics testing function best in a consolidated or distributed model? In Clinical Chemistry point-counterpoint articles John Longshore, PhD, FACMG, director of molecular pathology at Carolinas Pathology Group, extols the financial and operational advantages of a centralized core lab, while Frederick S. Nolte, PhD, professor of pathology and laboratory medicine at the Medical University of South Carolina, makes the argument that innovative molecular technologies would thrive more effectively under a distributed model.

Longshore asserts that a centralized or consolidated model would go a long way to reduce costs and make testing as efficient as possible. In his view, success of molecular testing depends on four factors:

  1. Consolidating the testing workflow for maximum efficiency;
  2. Cross-training medical technologists inside the molecular laboratory;
  3. Challenging staff skills;
  4. Controlling lab testing utilization.

The consolidated method invokes Lean strategies to create a single molecular lab that streamlines all laboratory services. “Under this method, core or consolidated laboratories may provide testing services for multiple hospitals, free-standing emergency departments, urgent care clinics, and physician offices,” Longshore explained. This approach aims to consolidate workflows, standardize testing methods, and increase access to clinical lab directors and skilled lab technologists, all which lead to improvements in testing utilization. The method also dispenses with single-test stand-alone platforms, using automated platforms that allow for the use of a wide range of assays.

“A significant advantage of the core molecular laboratory is often the expansion of testing to multiple shifts, which may lead to a highly efficient delivery of molecular testing services and decreased turnaround time for test results,” according to Longshore.

From a financial perspective, consolidation would also help to cushion the blows of the Protecting Access to Medicare Act of 2014 (PAMA). “The cuts to the PAMA clinical laboratory fee schedule (CLFS) come at a time when physicians increasingly rely upon expensive and poorly reimbursed molecular profiles to drive personalized medicine initiatives,” Longshore observed. Many healthcare systems have adopted a consolidated lab delivery model as a financial countermeasure against reduced payments under the CLFS.

Compared with a centralized approach, a distributed model for molecular testing would lead to financial stress for labs, requiring duplication of expensive lab equipment, Longshore asserted.

Nolte counters that “centralizing these diagnostic services is more difficult to justify,” given several major developments in molecular pathology. Technology is becoming less complex, and the U.S. Food and Drug Administration has been approving more tests. Nucleic acid-based testing has also become a standard of care.

“Ultimately, in my opinion, a more distributed model for molecular diagnostics is the best way to deliver these services and ensure that the entire laboratory medicine community is actively engaged with this revolutionary technology,” he wrote. The evolution of massively parallel sequencing (MPS) technology, for example, offers an argument for moving toward this model.

“At the time when the MPS technology was introduced, the implementation and running costs were significantly high, and core sequencing laboratories were warranted,” wrote Nolte. These costs have dropped significantly, however, as the technology has advanced, adopting applications in inherited disorders, cancer, infectious diseases, and HLA typing. In Nolte’s view, “MPS is probably best deployed in distributed rather than centralized fashion as it becomes integrated into the workflow of laboratory sections supporting these applications.”

CLIA-waived nucleic acid amplification tests (NAATs) also lend themselves to a decentralized model, suggested Nolte. Healthcare systems have been rapidly adopting these highly sensitive tests, which were approved by the FDA in 2015 and serve multiple purposes, such as detecting at the point-of-care influenza viruses and Streptococcus pyogenes. “Given the largely untapped commercial opportunities in point-of-care molecular diagnostics, the near-term future will likely bring rapid expansion in these test offerings for infectious diseases and other disorders. These tests represent the ultimate in democratization of molecular diagnostics because they are performed in near-patient settings by nonlaboratory personnel,” Nolte offered.

Nolte acknowledged that there was “no one correct way to deliver these services.” Technology improvements and local expertise are two factors that will ultimately drive the decision to centralize or decentralize, Nolte added.

Read Clinical Chemistry’s January special on molecular diagnostics for more insights on structuring molecular diagnostics services.