Patient risk management in laboratory medicine: an international survey to assess the severity of harm associated with erroneous reported results.

Abstract

Objectives: Patient risk management is an essential subject for clinical laboratory which is now central in main international laboratory quality standards (e.g., ISO 15989:2022; ISO 22367:2020 and CLSI EP23^2nd). Risk analysis is a necessary part of risk management which requires categorizing the severity of patient harm from a laboratory failure. However, this subjective task is not currently the subject of any recommendation and little literature about this topic. To remedy that, we conducted an international survey of medical biology professionals, asking them to rate a panel of 20 analytes the harm potentially induced by an erroneous reported result.

Methods: The survey was published by Bio-Rad^® to their customers base and the public with a dedicated webpage. The survey proposes to assign for the submitted analytes the amount of harm among five pre-defined categories of harm: negligible, minor, serious, critical, and catastrophic. Participants were also asked to specify their demographic characteristics.

Results: The questionnaires of 267 respondents coming from 43 countries were analyzed to allocate for each analyte a specific harm category. We highlight that almost all parameters (19/20) were categorized with at least a serious harm category and that none were associated with the negligible category.

Conclusions: This study constitutes the first international attempt to investigate how the laboratory community thinks about patient harm from an erroneous reported result. These results provide support to document the laboratory risk management policy which must now be centered on patient risk.