• Morales-Rayas, R., Zhou, S. (2023). Considerations for the Management of Incidental Findings in Clinical Laboratories. Canadian Standards Association, Toronto, ON.

Executive Summary

Incidental findings are findings that are unrelated to the original purpose of a clinical examination performed as requested on a lab requisition or order form. Clinical laboratory personnel encounter incidental findings during routine tests, examination panels, quality control, training, and method validation and verification. Once a finding is detected, laboratory staff need to know how to manage the finding, whether following an internal standard operating procedure or a guideline indicated in the laboratory quality documents. Current standards offer limited information on how to manage incidental findings in clinical laboratory medicine.

This report aimed to investigate relevant guidance on how to manage incidental findings in clinical laboratories performing routine biochemistry, hematology, coagulation, pathology, cytology, immunochemistry, microbiology, and molecular diagnostic tests. Academic and grey literature searches demonstrate that the disclosure of incidental findings in clinical laboratory medicine as well as research should consider technical aspects of the findings as well as ethical and legal consequences of the disclosure (or non-disclosure). A survey of Canadian clinical care and research laboratory personnel revealed that they came across incidental findings while performing biochemistry, hematology, microbiology, and anatomic pathology examinations. However, the process followed by laboratories when reporting incidental findings varied and most agreed that a national guideline is needed.

Overall, guidelines developed to support the disclosure of incidental findings should address issues of significance and actionability as well as ethical considerations such as autonomy, privacy, interest, beneficence, justice, and fairness. A significant barrier to addressing aspects related to autonomy or interest is the lack of consent or understanding of an individual’s preferences. In these instances, professional judgement is needed to weigh the benefits of disclosing a result versus not disclosing. Guidance developed for clinical laboratory personnel and health practitioners should involve all interested and affected parties, including patient advocacy groups, individuals with lived experience, caregivers, bioethicists, and health professionals.