Value-based hemostasis diagnostics: from laboratory information to clinical value

In hemostasis diagnostics, increasing analytical performance and test availability do not automatically translate into improved clinical outcomes. We propose value-based hemostasis diagnostics (VBHD) as a structured framework that links laboratory testing directly with patient-centered value and optimized resource utilization.

VBHD extends traditional appropriateness by considering five interconnected pillars: clinical relevance, analytical excellence, expert interpretation, diagnostic stewardship, and patient-centered value. This framework shifts the hemostasis laboratory's role from a passive testing service to an active clinical consultation partner. In this model, the laboratory consultant supports clinicians across the entire testing pathway - pre-analytical, interpretative, and post-analytical - helping translate complex results into actionable clinical actions. We discuss the clinical and economic implications of VBHD through practical hemostasis examples, including routine preoperative aPTT screening, VTE exclusion with D-dimer, inherited thrombophilia screening before combined oral contraceptive prescription, and steady-state DOAC measurement. We also present a Clinical Value Matrix to guide resource allocation and test prioritization based on clinical impact and diagnostic complexity, as well as a comprehensive ecosystem model mapping stakeholders, enablers, and system-level outcomes.

Moving from test-centered testing to decision-centered laboratory consultation can significantly reduce waste and avoidable harm while improving care quality. Evaluating the impact of VBHD requires a multi-level strategy spanning laboratory processes, diagnostic performance, clinical safety, and healthcare system efficiency.