Like most clinicians, I have considered the clinical laboratory as an important partner in the care of my patients during my 35 years of primary care internal medicine practice, but I always believed that the value of the lab ended when the results were released. Today, I am happy to report that a grassroots national movement termed Clinical Lab 2.0 takes this notion and turns it on its head.1 The laboratory leaders spearheading Clinical Lab 2.0 state that the value of the laboratory does not end when the results are released; rather, this is where the journey begins. I will translate what this is all about for our readership.
Clinical Lab 2.0 is a project of the Santa Fe Foundation, led by its charismatic founder, Khosrow Shotorbani. I first met Khosrow more than a decade ago when he was at the University of Utah in the Department of Clinical Pathology running their large clinical laboratory. I was intrigued by his vision of the laboratory of the future then, and I believed he was way ahead of his colleagues in articulating a future clinical action platform for academic pathologists.
This clinical action platform of Clinical Lab 2.0 has 4 quadrants: analyze, partner, engage, and test. I will first describe each quadrant and then circle back to the vision for Clinical Lab 2.0. The clinical action platform, to some extent, is their own quadruple aim but with a laboratory focus.
The “analyze” quadrant means that the laboratory will go beyond individual testing and will become a source for a center for clinical surveillance and high-risk identification of people who may need additional care. In other words, the laboratory will be a source of risk stratification for patients with serious comorbidities. In a world focused on value-based payment, a strategy to risk-stratify and close the feedback loop with providers sounds like a good idea to me!
The “partner” quadrant is unabashedly supportive of a population-health agenda. Coupled with a private–public partnership, the laboratory could be the first setting for chronic disease management, implementation of public health policies, and an early warning system as it relates to the health of the public (eg, widespread screening for COVID-19).
The “engage” quadrant is novel and seeks new ways and models of care for patients to engage directly with the clinical laboratory directly. It is a new world where patients can indeed look up their laboratory tests at any time and engage in an online conversation with multiple providers, something that was not possible even a few years ago.
The “test” quadrant is the cornerstone of what a clinical laboratory is really all about. In Clinical Lab 2.0, we are urged to go beyond the pathology domain and give feedback to clinicians about appropriate test utilization and application of clinical practice guidelines. In a world of value-based care and bundled payments, Clinical Lab 2.0 may become a true testing partner, helping me as a clinician to navigate complex laboratory testing options.
Beyond the clinical action platform and the 4 quadrants, however, a broader vision is articulated by Shotorbani. I had the privilege of participating at the Fifth Annual Clinical Lab 2.0 Workshop: Convergence of Laboratory Diagnostics and Population Health in the winter of this year in Chicago. At the workshop, I witnessed the enthusiasm of many attendees whom I once disparagingly said were basement dwellers in departments of pathology. Shame on me for that troglodyte attitude.
Key tenets of the new vision include the following: The laboratory is the best bargain and is yet to be leveraged to its fullest potential. The laboratory can facilitate intervention for early care management strategies—in essence, going upstream to shut off the faucet rather than mopping up the floor. The laboratory can identify gaps in care and high-risk patients at early stages, thereby practicing high-quality, low-cost care. The laboratory can stratify, track, and monitor clinical risk and escalate key issues early on, involving the appropriate clinicians in both primary care and specialists.1
The laboratory is the “first to know” and with zero latency can practice clinical surveillance. The laboratory has longitudinal touchpoints, meaning each touchpoint is measured by structured, actionable data. When we accumulate all of these touchpoints, we have a robust data set that provides insight into the health of large populations. The laboratory is a “first responder” and a powerful catalyst that can help amplify the population-health agenda for an integrated delivery system.1
Clinical Lab 2.0 calls for laboratorians to take a leadership role outside of the laboratory and, in their own way, pull up a seat at the “value-based payment table.” Clinical Lab 2.0 contends that laboratorians have reached—and even crossed—a strategic inflection point, or convergence, bringing together their traditional analytic work with a future focused on improving the health of specific populations. I can embrace this vision.
In Chicago this past winter, I saw the energy of the leaders that gathered around Khosrow Shotorbani. In the breakout sessions during the conference, these leaders described ongoing health services research projects that practically made me want to stand up and cheer. Clinical pathologists from highly rated organizations, such as Northwell Health in New York, the University of Vermont Health Network, and Geisinger Health System to name a few, described projects worthy of publication in a population-health journal. The projects included risk stratification, closing the gaps in care, and creating a dashboard showing measures of health for broad populations. These leaders viewed themselves as true “data whisperers” who can connect with clinicians in ways that I never thought were possible during my long career in primary care.
Kudos to the leaders of Clinical Lab 2.0 as they emerge from the basement and become full participants in the teamwork necessary to care for large populations. Personally, I never thought that the clinical laboratory could be the source of such massive innovation. I believe that the pandemic has accelerated the acceptance of the tenets put forth by Shotorbani and colleagues. I am confident that the clinical action platform, the 4 quadrants, and the key tenets will garner greater attention in the months ahead.
- Santa Fe Foundation: Clinical Lab 2.0. www.cl2lab.org. Accessed August 15, 2022.