Library
The Project Santa Fe Foundation Team is proud to share updates on our endeavors via Value-Based Care & Population Health Diagnostics Journals, publications, white papers, and press releases. Please browse our library and share with your colleagues as you see fit, at no cost to you. If you feel aligned with our thought leadership and would like to participate in our movement, we would be thrilled to hear from you. Please email us at info@cl2lab.org.
VBC Diagnostics Journal
Clinical Lab 2.0: A Value-Based Care Diagnostic Business Model with Alternative Payment Frameworks for Population Health
Mar 25, 2026
Clinical laboratories are facing significant economic pressure as the Protecting Access to Medicare Act (PAMA) driven reimbursement cuts erode margins and fee-for-service models become unsustainable. At the same time, nearly half of U.S. healthcare payments now flow through value-based arrangements, creating a pivotal opportunity for laboratories to realign with this new paradigm. This paper outlines…
Framing the Movement: Transforming from Reactive Confirmation to Proactive Prediction
Feb 25, 2026
An Architectural Framework for Healthcare Transformation Through Laboratory Medicine The transformation of laboratory medicine from reactive diagnostic confirmation to proactive disease prediction represents a fundamental restructuring. This paper proposes an architectural framework, defined as Framing the Movement, that proposes Clinical Lab 2.0 not as incremental healthcare reform but as a systematic architectural redesign. Drawing upon…
Enhancing Value-Based Care Through Laboratory-Assisted Identification of Care Gaps
Nov 12, 2025
The shift from fee-for-service to value-based care is transforming the role of clinical laboratories. Instead of being transactional providers of test results, the most forward-looking aim for laboratorians is to serve as strategic drivers of patient and population health. This idea is at the core of the Clinical Lab 2.0 movement , , which emphasizes…
Publications
The Role of the Clinical Laboratory in Diagnostic Stewardship and Population Health
Jan 3, 2025
Background: As healthcare identifies new opportunities to provide patient services and moves from volume to value payment models, the clinical laboratory is in an ideal position to serve as a catalyst for these changes. In 2017, the Project Santa Fe Foundation (PSFF) was founded to support the clinical laboratory’s role to promote the objectives of population…
Lab 2.0, Medicare 2030, AI – How they come together
Sep 11, 2024
The term value-based care is spoken of often, but what part do laboratories play in it and how can they be paid for it? What is Medicare 2030, and what does it mean for laboratories? How can AI be used to practice the medicine of tomorrow?
A Retrospective Multi-site Examination of Chronic Kidney Disease Using Longitudinal Laboratory Results and Metadata to Identify Clinical and Financial Risk
Apr 4, 2024
A retrospective, non-experimental, non-interventional study was conducted at 3 health care organizations to identify clinical gaps in care for patients with stage 3 or 4 chronic kidney disease (CKD), and financial opportunity from risk adjustment payment systems. Lack of evaluation for CKD in patients with diabetes was also assessed. Methods: Outpatient longitudinal laboratory results and patient…
White Papers
What We Walked Away With
April 8, 2026
We are all very aware that clinical laboratories and technology are rapidly evolving. From a Lab 1.0 model of confirming disease once symptoms appear to the Lab 2.0 approach of predicting risk earlier using data already generated in routine testing, we are moving the needle toward well-care and population health! At the Public Workshop, participants…
Clinical Lab 2.0 Lab Driven Care Model for Anemia
February 16, 2024
Anemia is a disease with high prevalence, high cost of care, and low quality of life. Through the engagement of clinical laboratories and diagnostic workflows, health systems can help improve the testing strategies, diagnosis, and patient outcomes for anemia. Clinical Lab 2.0, as shown in the model below3, highlights how the use of longitudinal laboratory…
Clinical Lab 2.0 Lab Initiated-Care Model for Chronic Kidney Disease
October 29, 2022
Chronic kidney disease (CKD) affects an estimated one in seven American adults, with about 37 million individuals having some level of CKD and is the ninth leading cause of death. Over 40% of patients with severe renal impairment are unaware that their kidneys are impaired. According to the CDC, $81.6 billion was spent on treating…
Press Releases
DMC Unveils ZetaStorm Platform at CL2.0 Public Workshop
Mar 24, 2026
Diagnostic Medicine Consortium Demonstrates ZetaStorm Platform Integrating Diagnostic Data, Real World Data (RWD), and Clinical Trial Forecasting Salt Lake City, UT — The Diagnostic Medicine Consortium (DMC)—a joint venture nonprofit of the Project Santa Fe Foundation and the Association for Pathology Informatics (API)—unveiled its emerging technology model at the Project Santa Fe Clinical Lab 2.0…
About DMC
Aug 14, 2025
Established March 3, 2025, the DMC is a strategic collaboration between the Association for Pathology Informatics (API) and PSFF, with an intent to include additional diagnostic-focused organizations. A 501(c)(3) non-profit new company is being established.
Clinical Lab 2.0 Signs Letter Demanding CLIAC Reinstatement
Jul 15, 2025
As our esteemed colleagues, you’re probably aware of the disbanding of the Clinical Laboratory Improvement Advisory Committee (CLIAC) by an executive order on March 31, 2025. For background, CLIAC was established in 1992 to allow for public input on the Clinical Laboratory Improvement Amendments (CLIA) regulations and to provide scientific and technical guidance related to…