Digital Specimen Tracking- and ISO 15189-Oriented Risk Management in Anatomic Pathology: A Qualitative Study of...

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.