Beyond counting errors: clinical pathway-specific preanalytical risk profiles in surgical pathology

Abstract

To determine whether clinical referral pathways exhibit distinct preanalytical risk profiles that could complement conventional laboratory-wide quality assessment in surgical pathology. We conducted a retrospective observational study of prospectively recorded preanalytical non-conformities in a tertiary academic pathology department between 2019 and 2024. Pathology requests underwent systematic conformity assessment at reception and were classified into predefined clinical referral pathways according to specimen acquisition workflow. Non-conformity incidence per 1,000 requests was analysed using negative binomial regression, and pathway-specific profiles were explored by hierarchical clustering. Among 68,274 pathology requests analysed over five complete years, 10,421 (15.3%) presented at least one preanalytical non-conformity, corresponding to 14,205 events. Overall incidence decreased from 203.0 to 79.0 non-conforming requests per 1,000 requests between 2019 and 2024. Marked differences persisted across clinical referral pathways. Compared with specialty outpatient clinics, adjusted incidence rate ratios were highest for image-guided procedures (5.40), operating room specimens (4.12), gynaecology and obstetrics (3.95), and medical wards (2.26). Hierarchical clustering identified distinct pathway-specific patterns of documentation, specimen handling and identification-related non-conformities. Preanalytical risk is not uniformly distributed across surgical pathology workflows but follows distinct clinical referral pathway-specific profiles. Incorporating pathway-specific analyses into routine quality assessment may complement conventional laboratory-wide indicators and support more targeted quality improvement strategies.