Value-based hemostasis diagnostics: from laboratory information to clinical value
BACKGROUND: 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. CONTENT: 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. SUMMARY AND OUTLOOK: 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.
Authors
- Valeria Coluccio
- Stefano Cordella (ORCID: https://orcid.org/0009-0007-2953-7193)
- Mario Luppi (ORCID: https://orcid.org/0000-0002-0373-1154)
- Vincenzo Nasillo (ORCID: https://orcid.org/0000-0001-5122-5574)
- Tommaso Fasano (ORCID: https://orcid.org/0009-0001-4549-9031)
- Marco Marietta (ORCID: https://orcid.org/0000-0002-8966-6567)
Institutions
- University of Modena and Reggio Emilia (IT)
- Azienda Unita' Sanitaria Locale Di Modena (IT)
- Azienda Ospedaliero-Universitaria di Modena (IT)
Publication Details
- Journal
- Clinical Chemistry and Laboratory Medicine (CCLM)
- Published
- 2026-10-16
- DOI
- https://doi.org/10.1515/cclm-2026-1382
- Primary Topic
- Clinical Laboratory Practices and Quality Control
- Type
- article
- Field-Weighted Citation Impact
- 0.00