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.

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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
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article

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

Valeria Coluccio, Stefano Cordella, Mario Luppi, Vincenzo Nasillo et al.
Clinical Chemistry and Laboratory Medicine (CCLM)
Clinical Laboratory Practices and Quality Control
article

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

Valeria Coluccio, Stefano Cordella, Mario Luppi, Vincenzo Nasillo, Tommaso Fasano, Marco Marietta
article en

Abstract

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.

Clinical Chemistry and Laboratory Medicine (CCLM)
University of Modena and Reggio Emilia (IT), Azienda Unita' Sanitaria Locale Di Modena (IT), Azienda Ospedaliero-Universitaria di Modena (IT)
Good health and well-being
Openalex Percentile: Top 13%
Clinical Laboratory Practices and Quality Control
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