Point: Comprehensive Molecular Testing Functions Best in a Consolidated Model

Healthcare systems face immense pressure to control costs while continuing to deliver high-quality services to patients. Although this cost control affects the entire clinical care delivery spectrum, its effects can be especially challenging for laboratory medicine. The Protecting Access to Medicare Act of 2014 (PAMA)² has left clinical laboratories within these systems searching for the best path forward to continue to deliver highly valued diagnostic information to the medical community (1). To further complicate matters, 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. Integrated healthcare systems have often moved to a consolidated laboratory delivery model to meet these challenges. Core or consolidated laboratories may provide testing services for multiple hospitals, freestanding emergency departments, urgent care clinics, and physician offices. There are substantial advantages to providing clinical laboratory services in a consolidated model, particularly for the delivery of high-complexity testing such as molecular pathology. The core laboratory strategy for molecular testing offers numerous advantages that include standardization of testing processes, consolidation of workflows, utilization of highly skilled laboratory technologists, and access to clinical laboratory directors, which could lead to improvement in the appropriate utilization of testing. All of the advantages offered by a centralized testing model are desirable in an era of increased financial scrutiny due to declining reimbursement on the CLFS.

In the shift from volume-based to value-based healthcare, there is a need for increased efficiency to allow laboratories to continue to deliver high-quality services. To increase productivity while decreasing costs, many integrated health networks have turned to the core laboratory model and implemented Lean processes and management principles. The conventional molecular testing delivery model has been highly fragmented and molecular services may be performed in the microbiology, virology, cytology, chemistry, hematology, or genetic services laboratory sections. This compartmentalization of testing markedly reduces operating efficiency and likely leads to inefficient utilization of testing platforms and staff. A shift to centralized molecular testing begins with consolidation of these service lines into a single molecular laboratory that offers services to support multiple areas of traditional laboratory medicine. Consolidation often allows for the use of highly automated, multiplexed testing platforms with broad menus of available assays, which eliminates reliance on single-test standalone platforms. 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.

A distributed testing model for molecular-based laboratory services would require duplication of costly laboratory equipment, which would be challenging to financially justify in today's environment of declining reimbursement. Additionally, the vast majority of DNA-based tests are performed as moderate- or high-complexity tests requiring on-site medical or technical directors with registered medical technologists, many of whom have additional molecular specialty certifications. Fewer molecular assays require a turnaround time that can't be met with an efficient core laboratory model and express transportation to the testing facility. For those tests requiring STAT results, CLIA-waived point-of-care assays are becoming available with relaxed testing personnel requirements. I do not believe that a centralized testing model is in conflict with the growing use of point-of-care molecular assays in some clinical scenarios. In fact, these testing approaches can be quite complementary. A good example of this is point-of-care or near-patient tests for respiratory infections. During respiratory virus season, it would be extremely challenging for a centralized laboratory to process the increased sample volumes and meet turnaround time needs for both inpatient and outpatient lines of service in an efficient manner. The availability of near-patient testing with a high-quality in vitro diagnostic (IVD) assay offering similar sensitivity and specificity to methods available in a centralized laboratory may lead to improved healthcare outcomes.

A modern integrated molecular pathology laboratory may perform testing within the areas of genetics, microbiology, virology, women's health, oncology, and pharmacogenomics utilizing both US Food and Drug Administration–cleared IVD tests and laboratory-developed tests for more esoteric targets. Cross-training of laboratory staff across these molecular focus areas can greatly improve appropriate utilization of our most valued asset in the laboratory, our technologists. Appropriate cross-training of laboratory staff can greatly improve employee engagement, testing efficiency, and job satisfaction and enhance the opportunity for testing staff to continue to expand their testing skills. As the molecular testing field continues to move toward automated options for high-volume testing, technical proficiency across all of the molecular testing disciplines can be an important asset to improve employee engagement and retention. Automated testing options for routine high-volume testing may offer increased opportunities for staff to focus on highly specialized and labor-intensive laboratory developed tests in oncology and genetics such as next-generation sequencing.

To be successful with molecular testing at the present time and to prepare for the increased utilization of molecular services in the future, there are 4 critical factors: (a), consolidation of the testing workflow for maximum efficiency; (b), cross-training medical technologists inside the molecular laboratory; (c), challenging your staff's skills; and (d), controlling the utilization of laboratory testing (2). Centralized molecular testing offers an opportunity for improved testing efficiency, lower assay costs, and the optimal utilization of testing staff. Having specialized technologists perform work on various molecular techniques across disciplines in genetics, oncology, microbiology, and virology can improve productivity, ease scheduling challenges in a 24/7 workflow, offer career development options, and increase intradepartment collaboration. As more molecular tests are placed on high-throughput automated instruments, laboratory staff have increasing amounts of time to devote to more specialized and labor-intensive tests. These nonautomated assays help to keep laboratory staff engaged in the testing process, improve job satisfaction, and can lead to an increased sense of self-worth in helping to drive the institution toward improved medical outcomes. One of the largest contributors to laboratory inefficiency is unnecessary or inappropriate test ordering. A centralized testing model allows restrictive ordering pathways to help prevent inadvertent duplication of testing by multiple healthcare providers and to decrease the frequency of inappropriate orders. The use of a multidisciplinary committee to control or manage laboratory test utilization may be an effective approach to consider.

In summary, I believe that consolidated molecular testing in a core laboratory environment is the best delivery method for nucleic acid–based tests. This approach allows for the most effective use of testing resources, integrated delivery of services, and appropriate financial stewardship in the current environment of medical economics. Given the present challenges faced by clinical laboratory medicine, our ability to deliver high-quality molecular testing services with decreasing CLFS reimbursement requires a consolidated testing approach.

Footnotes

Author Contributions: All authors confirmed they have contributed to the intellectual content of this paper and have met the following 4 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; (c) final approval of the published article; and (d) agreement to be accountable for all aspects of the article thus ensuring that questions related to the accuracy or integrity of any part of the article are appropriately investigated and resolved.

Authors' Disclosures or Potential Conflicts of Interest: No authors declared any potential conflicts of interest.

Acknowledgments

The author acknowledges Virginia C. Thurston, PhD, FACMG Director of Cytogenetics, Carolinas Pathology Group for her review of the manuscript.

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