Objective: To estimate the prevalence of technical errors in the total testing process of pathology tissue specimens.
Design: A systematic review and Meta-analysis of Observational Studies in Epidemiology was performed. Extracted data were pooled using a random-effects model and Grading of Recommendations, Assessment, Development and Evaluation approaches.
Data sources: PubMed, CINAHL, Cochrane Library and Science Direct databases were searched on 29 May 2025 for eligible studies.
Study selection: Peer-reviewed studies published after 2003 that reported technical error prevalence in any aspect of routine tissue collection and processing.
Results: The search returned 30 articles (31 studies), including data from 2 794 987 surgical pathology cases. Pooled effect sizes were calculated for pre-analytic errors at 16.71 per 1000 cases (95% CI 6.42 to 31.67), actively identified errors in the laboratory at 40.17 per 1000 (95% CI 7.04 to 97.61) and reported surgical pathology specimen errors at 4.94 per 1000 (95% CI 1.33 to 10.80). Subgroup analysis showed an occult error prevalence of 2.54 per 1000 cases (95% CI 1.63 to 3.64), and surgical pathology case contamination was 62.23 per 1000 (95% CI 8.22 to 159.33).
Conclusion and relevance: The analysis suggests that tissue processing technical errors are more prevalent than reported. A lack of standardised methods for defining and detecting errors contributes to undocumented and unidentified errors, leaving the true error prevalence unknown. The majority of clinical decisions are based on laboratory results; however, without reliable detection and reporting, errors in vulnerable processes risk compromising patient diagnoses.
Prospero registration number: CRD42024600518.
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