Citation

  • 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.

Authors

  • Rocío Morales Rayas, Ph.D., RBSO, CSA Group
  • Shiyao (Charlotte) Zhou, M.P.H.

Project Advisory Panel

  • Ayoob Ghalami, University of Toronto
  • Carol Cheung, University Health Network
  • Jennifer Robinson, McMaster University
  • Lianna Kyriakopoulou, Hospital for Sick Children
  • Robert Rennie, University of Alberta Hospital
  • Tracy Stockley, University Health Network
  • Anne Marie Martel, CSA Group (Project Manager)
  • Jennifer Teague, CSA Group

Acknowledgements

The authors would like to acknowledge the contributions of Buvaneshwari Balasubramania for her support with the survey. Thank you also to Kim Kordov, Associate Director, Research Ethics at the University of Alberta for her review of this report.

Disclaimer

This work has been produced by the author and is owned by Canadian Standards Association. It is designed to provide general information in regards to the subject matter covered. The views expressed in this publication are those of the author and study participants. The authors and Canadian Standards Association are not responsible for any loss or damage which might occur as a result of your reliance or use of the content in this publication.

Copyright

© 2023 Canadian Standards Association. All Rights Reserved.