Founding members of the Santa Fe Project discuss the role of pathology in improving population-level health
In a 2020 article in The Pathologist, the founders of the Santa Fe Project introduced the concept of the Clinical Lab 2.0: “a grassroots effort to transform the role of the diagnostic laboratory to better support the objectives of population health and value-based healthcare.”
Six years on, we caught up with members of the Santa Fe Project team to learn more about the principles they are advocating and how much traction the message has gained.
Meet the panel
How has Project Santa Fe – and the Clinical Lab 2.0 movement– evolved since the publication of your 2020 article?
James Crawford: Back then, in May 2020, we were still in the early, uncertain days of the COVID-19 pandemic. Looking back, it’s clear that the clinical laboratory sector played an extraordinary role worldwide in helping us navigate that crisis. That experience reinforced many of the principles we continue to emphasize today.
In terms of progress, we believe the message has landed. There is now broad global engagement – not just in the United States – around elevating the role of diagnostics and delivering healthcare based on value rather than volume.
The laboratory’s role is not simply to produce a data point at the end of a test, but to ensure that the information we provide leads to better patient care. That applies both to patients who are acutely ill and, increasingly, to identifying risk earlier – moving upstream to help prevent or delay chronic and acute disease.
From a more tactical standpoint, the foundation itself has continued to strengthen and accelerate its thought leadership. We see Project Santa Fe as a convening organization– bringing stakeholders together to rethink how diagnostics can optimize its strategic value in healthcare delivery, rather than functioning solely as a results-producing service.
Who are those stakeholders, beyond the laboratory community, and how are you engaging them?
Khosrow Shotorbani: Although the roots of this movement are diagnostic, we are very clear that this is not meant to be another laboratory forum. The people at the table may come from laboratories, but this is fundamentally a healthcare conversation. For Clinical Lab 2.0 to succeed, we have to engage the broader healthcare ecosystem – clinicians, policymakers, and industry partners.
We frame the movement around three core pillars: the science of laboratory medicine, with an emphasis on proactive risk stratification rather than simply reporting test results; healthcare economics, particularly cost avoidance and the efficient use of resources; and policy, focusing on the gaps that exist within it. Without meaningful engagement from policymakers and their constituents, this kind of change simply will not happen.
That framework also allows us to operate globally. While policy and payment systems differ from country to country, the underlying principles of laboratory medicine that we are promoting are universal – whether you are practicing in New Zealand or New Jersey. By anchoring the movement around our three pillars we are able to engage the organizations and individuals who can actually move it forward.
Why do you see the need to fundamentally disrupt the traditional laboratory medicine model on a global scale?
KS: Over the past four or five decades, innovation and technology development in laboratory medicine have been intense – particularly in genomics and genetics. Despite that innovation, we have largely embedded these capabilities into a fee-for-service model that is built around an “order in, result out” workflow. That model is fundamentally flawed in terms of realizing the full potential of what laboratory medicine can offer.
An order leading to a result does not, by itself, deliver a diagnosis or meaningful clinical impact. Our goal is to elevate the role of the laboratory by reengineering that process toward proactive prediction using longitudinal biomarkers. Early detection enables early prevention.
Based on my interations with colleagues in over 30 countries, the foundational model of laboratory medicine is remarkably consistent worldwide. To truly optimize the value of laboratory data, we need to disrupt that foundation in a fundamentally different way. I see this very much as a global issue.
How do you define value-based care in the context of laboratory medicine?
KS: The critical concept is detecting risk proactively – before it manifests as disease – and positioning that insight in a way that meaningfully impacts the healthcare value chain. Pathologists and clinical laboratories are uniquely positioned here; we are often the first to know and, in many ways, the first responders in this process.
As early as 2016, we argued in our manuscript that reducing time to diagnosis is central to diagnostic optimization, which enables care optimization, which in turn becomes the foundation for therapeutic optimization. With a surveillance model, that process becomes a continuous feedback loop: the clinical laboratory is involved at the front end and again at the back end, monitoring outcomes over time.
Surveillance is a critical element because it allows us to measure and manage risk – across populations and at the level of the individual patient. That, to me, is the essence of value-based care. It is about managing risk, not driving volume and being paid simply for producing more tests.
JC: Predictive risk management is not only about identifying who may become ill; it also reveals gaps in the care of patients with existing conditions, and where access to care is limited.
Some might argue that we already address this through population health initiatives – cardio–kidney–metabolic programs, for example. My response is simple: if that’s the case, why aren’t we doing better? By not fully involving the laboratory, we are missing a critical opportunity. Laboratories bring subject-matter expertise, operational expertise, and direct insight into the data itself. We are the ones generating these data, and that perspective matters.
This is a key part of our messaging: the laboratory – both as an entity and as a group of professionals – should be recognized as an asset to healthcare delivery, not treated merely as a commodity.
Can you point to examples where laboratory-led interventions have measurably improved patient outcomes?
JC: At my own institution, my department recognized an opportunity to play a much bigger role in improving patient care. First, as part of the Northwell "Sepsis Initiative", the simple act of ordering a lactate in addition to a blood culture was a critical component of improving patient survival. It meant that a physician was thinking of sepsis as a possibility
Second was acute kidney injury (AKI) testing at the point of hospital admission. By using elevated creatinine as a proactive laboratory-initiated trigger for immediate clinical assessment for AKI, the identification and rapid management of this condition was enhanced.
Recurrent pregnancy loss is another case, where cytogenetic testing for women with repeated losses was transformed into a proactive program to guide pregnancy management.
Antibiotic stewardship is another example – using rapid microbiology results to enable dose adjustment within two to four hours, which can preserve kidney function while treating bacteremia with the appropriately dosed antibiotics.
These are very tactical interventions. They can be measured, documented, and clearly tied to improved patient outcomes. And none of this happens in isolation – it’s always a team sport, working alongside broad clinical and programmatic teams. But the laboratory can step forward and say, “These are the laboratory data that drive better outcomes, and our programs need to be built around them.”
One area where there is still unfinished business is early identification of chronic kidney disease (CKD). In a 2024 BMC Nephrology paper, three leading health systems showed that laboratories already have the data to identify stage 3 and 4 CKD. Yet the proportion of patients who are actually diagnosed and treated remains far lower than it should be. There is significant opportunity there.
Are there real-world examples of laboratories successfully applying this value-based, population-focused approach at scale?
JC: TriCore Reference Laboratories published data showing how the laboratory proactively identified gestational diabetes risk and partnered with the state of New Mexico to reach expectant mothers in rural communities. Working alongside social workers, they ensured these patients received appropriate prenatal care, and the results were striking– a dramatic reduction in neonatal and NICU admissions.
They applied a similar model to managing patients with diabetes, identifying at-risk individuals in the same populations and collaborating with the state to ensure follow-up and treatment. These efforts are published and well documented. They are extraordinary examples of how laboratories can move beyond result reporting to actively improve population health outcomes through partnership, data, and proactive engagement.
What are the risks of not actively engaging in shaping value-based, predictive care models?
KS: If pathologists do not take an active role in this space, others will. And the consequence of that is the commoditization of pathology in a way that I believe will ultimately harm patient care. We can no longer remain confined to the analytical procedures of laboratory medicine and consider that sufficient.
Pathologists need to move beyond the four walls of the laboratory, claim a seat at the table, and help design the care models of the future– models grounded in prediction rather than a simple “order in, result out” mentality. Those days are over. We have to elevate our game.
What barriers exist around reimbursement for innovative pathology services, particularly in the US system?
Ullyses Baylis: The process for establishing new reimbursement codes in the US is extraordinarily Byzantine. Very few pathologists are ever exposed to it or truly understand how it works. As a result, only a small cohort of pathologists participates in shaping how new tests are recognized and reimbursed.
That’s a problem. We need a much larger group of pathologists who are prepared to engage in this process, because appropriate reimbursement models are essential for innovation to be sustainable. Right now, at least in US healthcare, this is a significantly underpowered area for pathology, and it limits our ability to translate new capabilities into routine clinical practice.
Beyond laboratory reimbursement, what broader system changes are needed to support proactive, value-based care?
JC: Payers need to support benefit structures that incorporate screening, proactive healthcare, and wellness, rather than focusing almost exclusively on reactive, sick care.
If benefit plans do not enable or incentivize early detection and prevention, it becomes much harder for laboratories and clinicians to deliver the kind of value-based care we’ve been discussing.
KS: We can no longer operate within isolated reimbursement “swim lanes.” Incentives have to be aligned across all clinicians who are working toward the same goals in patient care. If they are not, something in the system will inevitably break or become disruptive.
Going back to that CKD story, failure to diagnose this condition means that neither care for CKD takes place, nor does reimbursement occur for caring for these higher risk patients under value-based care systems. This is lost opportunity for CKD patients, and lost opportunity for upside benefit to laboratories for identifying CKD early in a patient’s course. That is not what I call aligned. Alignment is that we'll take the risk on the bottom side of incomplete health care, but there also has to be benefit on the upside of providing complete health care. If that doesn't happen, pathology will be cannibalized.
UB: If you look at most health systems – whether community-based or academic – they are still organized largely as silos. That makes the alignment problem especially acute. Consider a scenario in which proactive laboratory testing identifies an early-stage cancer. That patient is then referred to a cancer center, undergoes definitive surgery, and is effectively cured.
In that situation, there is typically no pull-through revenue model that recognizes the laboratory or pathologists as the instigating factor behind all the downstream care. That revenue is attributed entirely to the surgical silo, but the reality is that the laboratory was the catalyst that brought the patient into the system in the first place.
How do patients benefit from the practice of value-based healthcare?
JC: A key benefit for patients is a better understanding of their health. I use the word “health” deliberately, rather than “sickness,” because what enables you to live well is arguably more important than what makes you ill. Being able to coexist with chronic conditions, and understand the medical information that flows between you and your healthcare provider, is empowering.
Beyond managing what is already known, there is also the opportunity to identify risk earlier. That doesn’t have to be paralyzing – learning that your genome confers a future risk shouldn’t define your life. The question is how to live well, with or without existing infirmities.
Everything we’ve discussed points to an important role for the laboratory in that process. Active involvement by laboratory experts can directly support patient well-being. And laboratories can also serve as advocates for broader system changes, including better benefit design that truly supports proactive and preventive care.
What motivates you, personally, to pursue this work?
JC: At the very first Project Santa Fe meeting in April 2016, I invited the senior vice president for risk-based healthcare from my own institution. On the drive back to the Albuquerque airport, he said to me, “Jim, now I get it. To be a successful, integrated delivery network in the risk-based business, you have to have a great laboratory. Your laboratory has to be a must-have, not a nice-to-have.”
The alternative is commoditization. And a commodity, by definition, is the cheapest way to deliver a laboratory result. If you become commoditized, then by the stroke of a pen, the laboratory could cease to exist. The only way to avoid that fate is to act the part of Clinical Lab 2.0. For laboratories that want to be assets in the future, this is existential.
KS: Jim often reminds us that what truly gets us out of bed in the morning is the idea of improving the human condition – and he means that in the singular, not conditions in the plural. To me, that is the perfect mission statement for this movement. How do we improve the human condition? That framing gives real purpose to this work, and it’s why I find it so motivating.
JC: I’d also add that this work is genuinely fun. It’s empowering and nourishing. You get to collaborate with people across the entire house of medicine – clinicians, laboratorians, civic leaders, patient advocates, employers, payers, policymakers. Being in this space takes you far beyond what we were traditionally trained for, but pursuing these strategic objectives is a real joy.
The discussion continues in Part Two, “Value-based Healthcare: How Do We Get There?”
Newsletters
Receive the latest pathologist news, personalities, education, and career development – weekly to your inbox.
