Real-life data from standardized preanalytical coding (SPREC) in tissue biobanking and its dual use for sample...

Area of Science:

• Pathology
• Biobanking
• Quality Management

Background:

• The standardized preanalytical code (SPREC) is crucial for tracking warm ischemia time (WIT), cold ischemia time (CIT), and fixation time (FIT) in surgical specimens.
• Its empirical occurrence and impact on biobanked samples are not well understood, despite its importance in regulations like the European in vitro diagnostics regulation and NIH preanalytical programs.

Purpose of the Study:

• To determine the real-world occurrence of SPREC codes in biobanked surgical specimens.
• To analyze the impact of process optimization on SPREC parameters and biobanking workflows.
• To identify actionable insights for improving sample quality and traceability.

Main Methods:

• Collected and analyzed 10,555 CIT, 4,740 WIT, and 3,121 FIT values to establish informative SPREC codes.
• Applied LEAN Six Sigma principles for process optimization.
• Investigated dependencies of preanalytical variables on workload, time of day, and clinical factors.

Main Results:

• Achieved fully informative SPREC codes for a large cohort of surgical specimens across various organs.
• Demonstrated that SPREC coding serves as both a sample characteristic and a traceable process parameter.
• Optimized workflows reduced native tissue processing (CIT) turnaround times from 74.6 to 46.1 minutes under high workload.
• Identified organ-specific differences in WIT, CIT, and FIT values.

Conclusions:

• Real-life SPREC data highlight surgery-specific preanalytical limitations that can impact biomarker transfer.
• SPREC coding is highly beneficial for tissue banks and pathology institutes for process optimization and monitoring.
• FIT data suggest adapting SPREC fixation for specific embedding times and extending categories for weekend delays.