Population Health ManagementAhead of Print Open AccessFuture Role of the Clinical Lab in Population HealthKhosrow R. Shotorbani, Kathleen M. Swanson, and Beth BaileyKhosrow R. ShotorbaniProject Santa Fe Foundation, and Lab 2.0 Strategic Services, LLC, Salt Lake City, Utah, USA.Search for more papers by this author, Kathleen M. SwansonAddress correspondence to: Kathleen M. Swanson, MS, RPh, Pillar 3 Demonstration Projects, Project Santa Fe Foundation, 13612 Ernesto Ct NE, Albuquerque, NM 87112, USA E-mail Address: kathleen.swanson1@outlook.comhttps://orcid.org/0000-0002-8610-9001Project Santa Fe Foundation, Pillar 3 Demonstration Projects, Albuquerque, New Mexico, USA.Search for more papers by this author, and Beth BaileyProject Santa Fe Foundation, Albuquerque, New Mexico, USA.Search for more papers by this authorPublished Online:13 Aug 2021https://doi.org/10.1089/pop.2021.0167AboutSectionsView articleView PDFView PDF Plus ToolsAdd to favoritesDownload CitationsTrack Citations Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleBackgroundThe COVID-19 pandemic has illustrated how today's health care environment and current delivery models are ill-equipped to address community health and public safety. Through the process of “test, trace, treat,” the pandemic has moved public health and clinical diagnostics to the forefront. This collaboration during the pandemic has collectively informed health care policy, care delivery, and community actions, but a multitude of future opportunities still exist. Clinical laboratories can share the same objectives of population health by serving both individuals and populations1 through the 4 interacting concepts or pillars of chronic care management, quality and safety, public health, and health policy.2 This Point of View proposes an advanced role for clinical laboratories as a key partner in population health management by fostering partnerships with a broader group of stakeholders3 and supporting the Quadruple Aim.4Clinical laboratories can serve as the conduit for delivery on the principles of this collaborative model using the Clinical Lab 2.0 model. This model was first published in 2017 in Academic Pathology with an article entitled “Improving American Healthcare Through “Clinical Lab 2.0”: A Project Santa Fe Report.”5 The Project Santa Fe Foundation (PSFF) provided thought leadership and assisted in the development of the evidence base for the Clinical Lab 2.0 movement. The movement defines the future valuation of clinical laboratory services and evolution of the clinical laboratory business model. Using this new paradigm, laboratories can move from a transactional commodity delivering test results for sick care, defined as Clinical Lab 1.0, to an integrative component of value-based care providing clinical insights, defined as Clinical Lab 2.0.5 PSFF today actively supports organizations globally to demonstrate these principles. Publications describing Clinical Lab 2.0 concepts have highlighted the laboratory's role in population health and chronic disease management in support of value-based health care. Authors have demonstrated how laboratory data can contribute to clinical decision support, and actionable patient data,6,7 provide value for health plans monitoring chronic conditions such as diabetes,8 and apply laboratory analytics to support disease surveillance.9 These examples describe how the laboratory can collaborate to create clinical strategies for early disease identification, monitor chronic conditions, and support new disease management methods with clinical interventions to mitigate clinical and financial risk.Clinical Lab 2.0 can augment the reactionary “test, trace, treat” process through longitudinal clinical insights and analytics to promote early risk identification in chronic diseases and identify opportunities for intervention prior to hospitalization. Advantages would include downstream cost avoidance for many chronic and costly conditions. This hidden but measurable value from proactive laboratory insights allows for the recognition of illness before it has advanced and the monitoring of diseases at earlier stages of progression. Examples of this include chronic kidney disease and diabetes.The application of Clinical Lab 2.0 concepts described for chronic diseases also can be adapted for high-prevalence infectious diseases, including COVID-19. Application of the Clinical Lab 2.0 concepts to support the COVID-19 pandemic has the potential to extend collaboration with public health outside traditional infectious disease case count reporting. In this new, advanced role, the laboratory can serve as an essential resource for population health and public safety. Laboratories are first to know and can be the first to respond. Laboratories can provide predictive data analytics and facilitate clinical services to limit the spread of COVID-19, reengage those needing health care after the pandemic, and avoid unnecessary expenses to the health care system both now and after the pandemic.Future Role of Clinical Lab 2.0 in Population HealthUsing the Clinical Lab 2.0 concepts previously published and key partnerships needed in population health, a model for the future role of the Clinical Lab can be created. Key features of the model should include:1. consumer activation through shared decision-making and use of social determinants;2. a data lens for both the individual consumer and the larger population; and3. development of new health care delivery models that include primary care and chronic disease management.The clinical laboratory can support community health in this model by providing risk stratification, closing gaps in care, and facilitating clinical interventions, thus leading to improved outcomes and cost avoidance.This proposed model would have 4 major interlocking components working together to leverage the role of the clinical laboratory:1. Engage – Consumer Activation2. Test – Clinical Lab 1.03. Analyze – Clinical Lab 2.0, and4. Partner – Community HealthComponent 1: engage—consumer activationThe first element in the model is the engaged health care consumer. The consumer activation component identifies the importance of capturing and leveraging determinants of health to design care models of the future and promote improved access to care during the early stages of illness.10 Information and tools available to consumers would include the individual's personal data transformed into actionable insights, tools to address their determinants of health, and population health insights such as gaps in care and comorbidities. Patients ultimately would be connected to a community master patient index containing all health care information and laboratory results to promote an integrated, consumer-driven health care experience. Mechanisms to engage consumers may include comprehensive care patient portals and laboratory result interpretation.Consumer activation also may create opportunities to improve patients' access to care and inform their health care providers. Examples of this in the COVID-19 environment could include engaging specified patients to quarantine when needed or to continue routine health care with confidence during the pandemic for preexisting conditions.Component 2: test—Clinical Lab 1.0The second component of the model's foundation would be the laboratory's backbone of essential health care services: the delivery of timely and accurate test results with high sensitivity and specificity. This is defined as Clinical Lab 1.0. Fundamental attributes of Clinical Lab 1.0 are based in pathology and clinical laboratory science domain knowledge and represent the current focus of clinical laboratories to produce six sigma high-quality results within an actionable time frame for clinical treatment decisions. Other attributes of Clinical Lab 1.0 include appropriate test utilization to ensure the right test at the right time for the right patient, and supply chain management to reduce cost per test. Additional services in this component might include point-of-care testing (POCT), the collection of biometrics and other clinical data in the laboratory, and delivery of phlebotomy services in the patient's home. An example of this with COVID-19 would include the provision of POCT in congregate care living facilities to protect high-risk individuals. Clinical Lab 1.0 activities build a longitudinal record of measurable and actionable laboratory data.The first 2 components – consumer engagement and clinical laboratory testing – generate a comprehensive data platform to support the remainder of the model.Component 3: analyze—Clinical Lab 2.0Atop the foundation of consumer engagement and laboratory testing, the third component of the model would be Clinical Lab 2.0 insights. Clinical Lab 2.0 insights allow laboratories to harness aggregate longitudinal lab data with a patient-centric view to identify, stratify, track, and monitor patients. Use of longitudinal data to develop actionable insights for members of the health care ecosystem (provider, patient, payer, health system) might include identification of clinical risk from comorbidities, gaps in care for chronic conditions, and facilitation of health care interventions using the laboratory's infrastructure. Clinical Lab 2.0 insights have the potential to improve clinical and financial outcomes and decrease disease burden.These actionable insights require several fundamental ingredients: understanding of disease prevalence and the associated clinical and financial burden, active laboratory leadership and lab medicine domain knowledge, and longitudinal laboratory data. Longitudinal laboratory data include not just laboratory results for patients but also metadata gathered from laboratory orders. Examples of metadata include geographic data such as county or zip code, gender, age, location of health care services (ie, emergency room, urgent care, outpatient provider, hospital), concomitant health conditions (both chronic and acute), and social determinants of health. This untapped information coupled with laboratory results offers the advantage of having near zero latency and being regularly updated as a result of frequent touch points with the laboratory.Clinical Lab 2.0 insights also may include the provision of more actionable and understandable laboratory results for the provider, patient, and caregivers. This supports consumer engagement by empowering patients to manage their chronic disease. The value proposition of Clinical Lab 2.0 insights is most notable when used to support early identification of a condition prior to disease progression.When applied to COVID-19, these components can be used to proactively stratify patients at risk after testing positive, identify patients needing isolation and quarantine, provide follow-up for post-COVID care, and support health care systems to deliver chronic disease care to non-COVID patients, thereby supporting revenue generation.Component 4: partner—community healthThe last component of the model activates partnerships with the key stakeholders of population health to create implementation strategies and policies needed in this new era of health care. Lab's alignment with these stakeholders will be essential to make the model effective. Partnerships with community health would leverage the lab's existing relationships, Clinical Lab 1.0 testing results, and Clinical Lab 2.0 insights from data analytics and data platforms. Additional public and private collaborations also could be an important part of this component with providers, payers, and health information exchanges. The domain knowledge of laboratory medicine, its vast patient touch points, physical proximity to patients, and real-time insights all support the clinical action platform.Future ModelsThe potential value of the clinical laboratory does not end at the time the test result is released; rather, this is where the laboratory's value continues. By working together, laboratories and community health groups can become active participants in the design and implementation of future delivery models, quantitatively demonstrate how they contribute to clinical outcomes, and align with financial incentives for health care organizations. The pandemic has clearly demonstrated the role for laboratories and community health to support population health with consumer-driven shared decision-making models focused on improving health outcomes, reducing the overall cost of care, and decreasing prevalence of disease.Authors ContributionsMr. Shotorbani, Ms. Swanson, and Ms. Bailey all made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; and drafting the work or revising it critically for important intellectual content; and final approval of the version to be published. All agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.AcknowledgmentsThe following Individuals are acknowledged for their substantial contributions to the conception or design of the work: Mark K. Fung, MD, PhD and Jill Warrington, MD, PhD from the University of Vermont Health Network, and Michael J. Crossey, MD, PhD from TriCore Reference Laboratories.Author Disclosure StatementMr. Shotorbani declares prior employment, in the last 5 years as CEO of TriCore Reference Laboratories. TriCore Reference Laboratories has supported the Clinical Lab 2.0 movement and has participated in the development and implementation of Clinical Lab 2.0. He currently serves as Founder, CEO of Lab 2.0 Strategic Services, LLC. Ms. Swanson declares prior employment, in the last 5 years, as Director, Diagnostic Optimization with TriCore Reference Laboratories. Ms. Bailey declares current employment, in the last 5 years, as Director, Strategic Development and Communications with TriCore Reference Laboratories.Funding InformationNo funding was received for this article.