Lessons in the Core Lab Model

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Vol. 25 • Issue 7 • Page 14

Molecular Diagnostics

Today’s changing healthcare landscape has introduced significant challenges to clinical laboratories, such as decreased reimbursement and an increased demand for testing, despite ongoing labor shortages. Molecular labs, in particular, are being asked to increase productivity while decreasing costs, and to demonstrate their contribution to their institution’s success.

Rewind the lab industry about a decade, and today’s molecular lab challenges look strikingly similar to the ones that core chemistry and hematology labs were facing. Some of the hallmarks of today’s core lab model-consolidated chemistry and hematology lab operations, integrated chemistry and immunoassay platforms with expanded menus and sample in-result out automation-played a key role in the success of their evolution. Some molecular labs are beginning to ask if a similar paradigm shift may be one of the keys to long-term success for the molecular lab-especially in the area of routine or high-volume PCR testing.

Lean Operations and Staff Optimization

The dynamic healthcare environment is creating the need for molecular labs to consider consolidating and centralizing their higher volume routine PCR testing, such as viral loads and women’s health/STI tests, on larger, automated platforms.

Moving to more of a core lab model for routine testing can help address some of the inherent reasons that the conventional molecular testing model creates barriers to achieving the efficiency, productivity and Lean operations common in today’s core chemistry lab. For example, in contrast to the concept of a centralized core lab, most molecular testing today is highly fragmented, both by geographic location and type of testing (e.g., infectious disease testing is performed in the micro lab, STI testing in cytology, etc.). In addition, many routine molecular tests are performed on standalone platforms that are dedicated to a single test or can’t accommodate mixed runs or consolidated test menus-all normal capabilities of today’s core chemistry lab.

The net impact of these factors is significantly reduced operating efficiency with diminished ­utilization of equipment and staff. Labs also have a decreased ability to provide a comprehensive and coordinated test profile to help physicians make informed, timely decisions that improve patient care.

The impact of underutilized staff is particularly relevant to the molecular lab. Some sources estimate that the allocation of a lab’s budget to labor is 70%.1 Yet much of the valuable time of molecular medical technologists is often spent on routine activities that do not require their skill level (e.g., manual specimen preparation and transport, archived sample retrieval, data entry). Using highly trained technologists for routine, mundane tasks is a waste of resources that can negatively impact lab efficiency, staff engagement, retention and, potentially, patient care.

While the shift to centralized testing and a core lab model may present physical and logistical challenges, the potential benefits clearly justify the pain of change-improved efficiency, lower overall cost per test, better personnel utilization and improved patient care.

Beyond Silos

Automation is also moving beyond its traditional borders in the centralized testing arena by crossing over lab types. For example, our company just introduced a modular connection system for the chemistry lab to enable the automated online connection of pre-analytical systems to a broad range of analyzers and post-analytical units-including components in the molecular lab and, potentially, blood banks as well. This kind of connected lab model has the potential to deliver improved testing efficiency and better utilization of staff resources, and to streamline the delivery of consolidated patient reports and actionable data as well.

Another critical component of this automation evolution is integrated IT and workflow management systems. Specimen tracking and workflow management programs can be combined with highly automated pre-analytical, analytical and post-analytical ­systems to address inefficient, time-consuming manual processes that still dictate the work set of many areas of the clinical molecular lab.

Direct and Indirect Benefits

These emerging trends in automation are making it easier for labs to increase efficiency and productivity, lower operating costs and make better use of staff and resources. Just as important, this shift toward an automated environment is also helping labs demonstrate and redefine the value they provide in delivering actionable diagnostic information that contributes to improved patient outcomes and a better overall experience for physicians working with the lab.

There are also several indirect benefits of automating routine PCR testing to adopt more of a core lab model. In terms of price-to-performance ratio, labs often focus on the reagent cost component of a test, but it’s also important to look at the overall operational cost of testing. With platform consolidations and centralized testing, a lab can run multiple routine tests on a single piece of equipment, which helps limit capital expenses and uses staff and resources more effectively. This enables a lab to achieve excellent performance while controlling costs.

Additionally, adopting a more centralized structure for routine molecular testing can facilitate the development of integrated, comprehensive patient test reports. In the traditional molecular model, patient test reports are often sent with only one result per page. In contrast, chemistry and hematology labs typically ­present a consolidated report. Combining the information for related tests into a single report increases the value of the information to the physician and the patient.

Finally, several of the benefits of adopting a core lab model for routine PCR testing-such as increased efficiency, consolidated patient reports and more time for technologists to focus on specialty testing-can significantly enhance a molecular lab’s ability to demonstrate the value of test results in improving patient care. They can also make it easier for labs to collaborate effectively with other disciplines and help reinforce the value of the molecular laboratory in the healthcare system.


References:

Valenstein PN, Souers R, Wilkinson DS, College of American Pathologists. Staffing benchmarks for clinical laboratories: a College of American Pathologists Q-probes study of staffing at 151 institutions. Arch Pathol Lab Med. 2005;129:467-473

The author would like to thank John W. Longshore, PhD, FACMG, director of molecular pathology, Carolinas Pathology Group and Carolinas HealthCare System; and Paul Lambert, vice president, IT Commercial Operations, Roche Diagnostics, for their contributions to this article.

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About Author

John McCune

John McCune is group marketing manager, Systems and Automation, Roche Diagnostics.

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