Level 1: Quality and Compliance (Base Level – to achieve normalcy and predictability) with emphasis on analytical accuracy, QC and QA practices and regulatory and accreditation compliance. The focus of these laboratories is on technical excellence and standardization of processes to ensure patient safety and data integrity. The outlook of the laboratory moves from being reactive and correct errors to being proactive in preventing occurrence of errors and hence mitigating risk. 1, 2

Level 2: (Establishing and meeting standards of value) Aim towards operational efficiency with emphasis on optimization of internal processes and utilization of resources through Lean Six Sigma methodologies, Workflow automation and LIS integration, waste reduction and TAT optimization. 3

Level 3: (Delivering value that exceeds expectations) Ensuring Clinical Effectiveness with the laboratories actively contributing to clinical decision making. 4 Until a few decades ago, the role of laboratory test result was to confirm the clinical diagnosis and to monitor disease progress or response to treatment. In the current context of advanced technology, availability of biomarkers and the “omics” revolution however, laboratory medicine plays an increasingly dominant part in influencing clinical decision making. This is a significant step towards value based laboratory medicine and a step away from the volume based transactional model. The primary goal of value-based laboratory medicine is to maximize the effectiveness of laboratory testing by leveraging disruptive technologies and patient based algorithms to improve patient outcomes, optimize resource utilization and minimize unnecessary wastage and costs. This may be achieved by a) providing context-rich, actionable test reports b) Supporting evidence-based diagnosis and therapy monitoring c) Reducing diagnostic errors and unnecessary testing. Smart test reports with interpretative comments by pathologists, advice on reflex testing algorithms, notes explaining how test reports need to be interpreted with knowledge of their utility and limitation in the given clinical situation are other options. Current evidence shows that misinterpretation of laboratory information is the second most common cause of medical errors. 5

Level 4: Healtchare System value (Apex Level – Best in class) – This level embodies transformational leadership where laboratories partner with clinicians, payers and administrators to shape healthcare delivery through a) Population health analysis b) Risk stratification in chronic disease management c) Precision medicine and companion diagnostics d) Public health surveillance and outbreak response. 8