Digital Specimen Tracking- and ISO 15189-Oriented Risk Management in Anatomic Pathology: A Qualitative Study of Expert Perspectives in Western Austria

TL;DR

Experts in anatomic pathology in Austria discuss challenges and solutions for digital specimen tracking and quality management aligned with ISO 15189 standards.

Contribution

The study provides a pragmatic roadmap for implementing ISO 15189-oriented risk management in specimen tracking.

Findings

Interface management and handovers are critical vulnerabilities in specimen pathways.

Barcode-based identification and closed-loop traceability are essential for quality and risk management.

Interoperable IT systems are needed to reduce paper–digital handoffs and improve data integrity.

Abstract

Background: Breakpoints in the pre-examination processes and at organizational interfaces are a significant source of failures in specimen identification and tracking in anatomic pathology. While ISO 15189 emphasizes end-to-end traceability and risk-based quality management, implementing these principles in complex, multi-actor specimen pathways remains challenging. This study explores expert perspectives on specimen process chains, tracking mechanisms, and ISO 15189-oriented quality and risk management in pathology. Methods: We conducted 10 semi-structured expert interviews across three settings. Interviews were audio-recorded, transcribed, pseudonymized, and analyzed using structured qualitative content analysis (Mayring) supported by MAXQDA. A deductive category system derived from the theoretical framework and interview guide comprised six main categories and twelve subcategories. Results: Across 512 coded text segments, participants identified several factors as critical for effective implementation, including: (i) interface management along the specimen pathway, with recurrent vulnerabilities at handovers between operating theater/ward/transport and accessioning; (ii) the central role of barcode-based identification and the need for closed-loop traceability; (iii) the importance of measurable quality indicators and incident learning systems to operationalize risk management; (iv) persistent paper–digital handoffs and heterogeneous IT landscapes that undermine data integrity; (v) the need for clearly assigned responsibilities, training, and SOP governance; and (vi) implementation barriers including resources, change management, and vendor integration, alongside practical enablers such as incremental roll-out and cross-professional governance. Conclusions: Experts converge on a pragmatic ISO 15189-aligned roadmap: prioritize interface risks, standardize identifiers and handover rules, define a minimal KPI set for tracking and misidentification events, and reduce paper–digital handoffs by interoperable IT. Future work should quantify baseline error rates and evaluate the impact of digital tracking interventions on patient safety and turnaround times.

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