Failure mode and effects analysis-guided digital redesign of the intraoperative frozen-section specimen pathway: a before-and-after service improvement study

Background Intraoperative frozen-section specimen pathways cross professional and departmental boundaries and are vulnerable to identification, handover, and transport failures. A failure mode and effects analysis (FMEA)-guided closed-loop workflow redesign may provide a structured approach to improving specimen traceability and reducing preventable process failures. Aim To evaluate an FMEA-guided digital redesign program incorporating a dedicated frozen-section pathway, standardized verification procedures, barcode-based handover, repeat-submission registration, targeted training, and real-time workflow monitoring. Methods This single-center, non-randomized before-and-after study was conducted at a tertiary teaching hospital in eastern China. All registered frozen-section specimens from October–December 2025 (pre-implementation; n = 238) and January–March 2026 (post-implementation; n = 247) were included. The intervention included a dedicated frozen-section pathway, standardized verification procedures, a single-record register for repeat submissions, barcode-based handover, role-specific training, and real-time monitoring of workflow deviations. Results Transport timeliness improved from 80.7% (192/238) before implementation to 98.4% (243/247) after implementation, representing an absolute increase of 17.7 percentage points (95% CI 12.5–23.0; risk ratio 1.22, 95% CI 1.14–1.30; p < 0.001). Handover-record accuracy improved from 75.2% (179/238) to 99.2% (245/247), representing an absolute increase of 24.0 percentage points (95% CI 18.4–29.6; risk ratio 1.32, 95% CI 1.23–1.42; p < 0.001). Staff-reported satisfaction increased descriptively from 71.0% (44/62) to 95.2% (59/62).