Pathology experts press for closed-loop specimen tracking and ISO 15189 discipline
Failures in specimen identification rarely begin in the microscope room. They start earlier, at the handoff between ward, operating theater, transport, and accessioning, where labels can be mismatched, paper slips can outpace digital records, and responsibility can become diffuse enough to hide the point of failure.
A qualitative study from western Austria places those breakpoints at the center of an anatomic pathology safety agenda shaped by ISO 15189. Across 10 semi-structured expert interviews spanning three settings, participants converged on a simple clinical truth: specimen safety depends less on one perfect device than on a well-controlled chain of custody that survives every interface.
Handover failures and barcode discipline define the highest-risk points
The strongest consensus in the interview data centered on interface management along the specimen pathway. Recurrent vulnerabilities appeared at the transfer points between clinical teams, transport personnel, and accessioning staff, where a single lapse can create a misidentification event or a delay that contaminates the integrity of the entire case. In pathology, those moments matter because the specimen itself cannot be reconstructed once the chain breaks; the tissue is the evidence, and the label is the patient.
Barcode-based identification emerged as the operational anchor for that chain. Experts described closed-loop traceability as essential, not optional, because the value of a barcode system lies in its ability to connect collection, transport, receipt, processing, and reporting without forcing staff to re-enter data by hand. Manual re-entry creates a second opportunity for error and a first opportunity for drift between what was collected and what the information system believes was collected.
Persistent paper-digital handoffs stood out as a recurring structural weakness. When documentation moves back and forth between handwritten forms and electronic systems, the result is not simply inefficiency; it is a degradation in data integrity that complicates risk management and can obscure the root cause of a specimen event. Heterogeneous IT environments made that problem worse, especially when vendor systems did not integrate cleanly across the pre-analytical and analytical phases.
Qualitative coding turned expert opinion into a map of operational risk
The investigators used 10 semi-structured expert interviews, audio recording, transcription, pseudonymization, and structured qualitative content analysis with MAXQDA. A deductive category system, built from the theoretical framework and interview guide, organized the findings into six main categories and twelve subcategories. Across 512 coded text segments, the interviews produced a coherent view of where pathology workflows fail and what would be needed to harden them.
This design does not measure event rates, but it does do something important for patient safety work: it identifies the places where measurement should begin. Qualitative studies are often strongest when they expose the hidden architecture of a process, and in this case the architecture is a specimen pathway with multiple actors, fragmented responsibilities, and uneven digital maturity.
Quality indicators and incident learning move risk management from theory to practice
Experts consistently pointed to measurable quality indicators as the bridge between abstract risk management and day-to-day operations. Without a defined set of metrics, ISO 15189 can become a certification framework rather than a safety engine. With the right indicators, it can support routine surveillance for misidentification events, near misses, and workflow failures before those problems reach diagnostic reporting.
Incident learning systems were treated as equally important. In a high-reliability specimen chain, near misses carry as much practical value as confirmed errors because they reveal where the process nearly failed and where staff workarounds have started to substitute for standard procedure. A robust reporting culture allows pathology services to detect patterns early, whether the issue is a recurring handover weakness, an unclear naming convention, or a transport step that routinely relies on informal knowledge.
One clear conclusion emerged from the interviews: risk management cannot be bolted on after digitalization. It has to be built into the digital workflow itself.
Responsibility, training, and SOP governance determine whether systems hold
Technology alone did not solve the problems described by the experts. Clear assignment of responsibility, staff training, and standard operating procedure governance were repeatedly described as prerequisites for successful implementation. If no one owns the handover, the barcode scan, or the response to a discrepancy, then the system may look organized on paper while remaining fragile in practice.
The interviews also pointed to change management as a practical barrier. New workflows require buy-in from operating room teams, ward staff, transport personnel, accessioning teams, and laboratory leadership. Each group works under different time pressures, and each may see specimen tracking as one more administrative step unless the process is designed to fit the clinical reality of specimen collection and transport.
Incremental rollout and cross-professional governance emerged as practical enablers. That combination matters because specimen tracking succeeds when the people who generate the specimen, move the specimen, receive the specimen, and validate the specimen all help define the rules.
Interoperable IT is the most direct path to fewer weak links
The study’s most actionable digital insight concerns interoperability. Heterogeneous systems and vendor silos create redundant work, force paper-digital workarounds, and weaken the end-to-end audit trail that ISO 15189 expects. Interoperable IT reduces those weak links by allowing identifiers, timestamps, and custody changes to move through the system once rather than being recreated in separate places.
That technical goal has a bedside consequence. When specimen identity is stable, diagnostic turnaround can improve, delays from clarification calls can fall, and the laboratory can spend less time repairing metadata and more time delivering results that clinicians can trust. In anatomic pathology, speed without traceability is not a gain; it is exposure.
The authors’ practical roadmap is straightforward: prioritize interface risks, standardize identifiers and handover rules, define a minimal KPI set for tracking and misidentification events, and reduce paper-digital handoffs through interoperable IT. Future work will need to quantify baseline error rates and test whether digital tracking changes patient safety outcomes and turnaround times in measurable ways. Until then, the value of this study lies in where it points the next audit, the next process redesign, and the next investment in specimen-chain reliability.