The evolution of routine PCR testing: insights from the core lab model

Oct. 22, 2015

Clinical laboratories face significant challenges today including decreased reimbursement, a shift from volume-based to value-based healthcare, and labor shortages in the face of increased demand for testing. Molecular labs, in particular, are being asked to increase productivity while decreasing costs, and to demonstrate their value and contribution to institutional success.

But the more things change, as the saying goes, the more they stay the same—in a way. These challenges are strikingly similar to the ones that core chemistry and hematology labs faced a decade ago. While substantive differences exist in test methodologies and complexity, some molecular labs are beginning to look at the evolution of the core lab model and 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 polymerase chain reaction (PCR) testing.

Barriers to efficiency and productivity

There are several components of the conventional molecular testing model that inherently limit the lab’s ability to achieve the types of efficiency, productivity and LEAN operations that are commonplace in today’s core chemistry lab. These limitations also hinder its ability to provide increased value to the healthcare institution or integrated health network it serves.

Decentralized structure and platforms. In sharp contrast to the concept of a centralized core lab, most molecular testing today is highly fragmented—e.g., genetic testing performed in a genetic lab, infectious disease testing in a microbiology lab, STI testing in cytology, etc. In many cases, this silo effect is intensified by physical or geographic separation of the labs. In addition, much routine molecular testing is performed on standalone platforms that are dedicated to a single test and/or are limited in their ability to accommodate mixed runs or consolidated test menus—capabilities that are common in core chemistry labs.

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

Underutilized staff. Some sources estimate that the allocation of a lab’s budget to labor is 70 percent.1 Yet much of the valuable time of molecular laboratorians is often spent on routine activities that do not require their skill level—manual specimen preparation and transport, archived sample retrieval, data entry, etc. These non-technical tasks are neither the occupation they were trained for nor what they enjoy doing.

Using highly trained technologists for routine, mundane tasks is a waste of resources that can negatively impact “technologist ROI” (return on investment)—affecting lab efficiency, staff engagement, retention and, potentially, patient care.

Critical factors for future success

There are four key operational strategies—some of which are hallmarks of the core lab model—that can help molecular labs overcome these challenges and ensure their long-term success. Ideally, they represent the foundation of a clearly defined strategic vision that can help illustrate the molecular lab’s value to the institution.

Consolidation of workflow. Market forces are creating the need for molecular labs, especially those with moderate-to-high testing volume, to consider consolidating their higher-volume routine PCR testing, such as viral loads and women’s health/STI tests, on larger, automated platforms. This shift to centralized testing and a core lab model may initially present physical and logistical challenges, but it can yield improved efficiency, lower overall cost per test, and better utilization of laboratory staff.

Our health network recently consolidated its molecular testing into a system-wide core laboratory to eliminate duplication of services that existed across our hospital system. In addition to greater efficiency and staff utilization, our goal was to improve the experience that physicians and patients have when working with the lab.

It’s important to note that this shift to centralized testing for routine PCR testing does not conflict with the emerging practice of point-of-care molecular testing (POCT) for respiratory infections. They are complementary strategies to manage different types of testing. It would be extremely challenging for a molecular lab to handle the testing volume during respiratory virus season for both inpatients and outpatients. Having near-patient molecular methods available helps labs improve healthcare outcomes and staff adequately for the increased demand for testing in respiratory virus season.

Cross-training staff. In a molecular pathology lab that incorporates testing for genetics, virology, microbiology, women’s health, and oncology markers, there is great value in having laboratorians be cross-trained among the molecular testing disciplines. While it may not be feasible to implement cross-training outside of the molecular lab, training staff on various disciplines within the lab can greatly improve productivity, enhance career development, and optimize the contribution of skills to the success of the lab.

Challenging staff’s skills. The field of molecular pathology is evolving rapidly, and as more automated options emerge for routine IVD tests, it helps free up time to let laboratorians focus on high-value, esoteric testing that is more specialized and labor-intensive, such as lab developed tests (LDTs) or next generation sequencing (NGS). This keeps staff fresh and engaged in the process, and can provide opportunities to expand skill sets in support of the institution’s mission and improve labor ROI, job satisfaction and staff retention.

Controlling utilization. One factor that contributes to lab inefficiency and non-value-added cost is inappropriate test orders and frequency, including duplicated or repeated test orders. For example, a lab may get multiple requests for a cystic fibrosis test or a Factor V test on the same patient. But a patient’s genotype does not change over time, so the result would not be expected to change. In a large practice or integrated health network (IHN), a patient may be seen by several healthcare providers who may inadvertently repeat an order for a test. A reliable way to improve utilization is through a physician champion or multidisciplinary committee that seeks means to control or manage utilization.

Additional considerations

Molecular labs have the potential to realize two other indirect benefits by shifting their routine PCR testing to more of a core lab model.

Improved price-performance ratio. Labs traditionally focus on the reagent cost component of a test, but it’s important to look at the overall operational cost of testing, including hands-on time for staff, instrument time, instrument reliability, and test repeat rate. With platform consolidation and centralized testing, a lab can run multiple routine tests on a single piece of equipment, which helps limit capital expenses and uses labor effectively. Our laboratory assesses the overall price-performance ratio for tests and chooses platforms and tests to get excellent performance while controlling costs.

Consolidated reporting. 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 on the page. In contrast, chemistry and hematology labs typically present a consolidated report. By offering a consolidated report for all of areas of laboratory testing, whether it’s a multi-gene profile for an oncology patient or a cervical biopsy and related tests, putting the information into a single combined format increases the value of the information to the
physician and to the patient.

Demonstrating value in personalized medicine

Molecular labs play an increasingly vital role in personalized medicine, especially in the areas of companion diagnostics and targeted therapies. 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 laboratorians 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, such as pharmacy, oncology, primary care, pediatrics, and internal medicine, and thus redefine the value of the molecular laboratory in the healthcare continuum.


  1. 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(4):467-473.
John W. Longshore, PhD, FACMG, serves as Director of Molecular Pathology for Carolinas Pathology Group and Carolinas HealthCare System, an integrated health network with more than 40 hospitals. He oversees molecular testing for inherited disease, virology, microbiology, hematologic malignancy, and solid tumor analysis.