Incidents in Molecular Pathology: Frequency and Causes During Routine Testing

Area of Science:

• Laboratory Medicine
• Molecular Oncology
• Patient Safety

Background:

• Errors in laboratory medicine can jeopardize patient safety.
• Effective laboratory practice necessitates identifying and managing nonconformities throughout the total testing process.
• Data on error rates in molecular oncology are limited.

Purpose of the Study:

• To investigate the causes and frequency of incidents within the total testing process at eight European institutes.
• Focus on biomarker testing for non-small cell lung cancer and colorectal cancer.
• Identify critical points for intervention to improve quality and safety.

Main Methods:

• Collection of all documented incidents from 2018 across all hospital services.
• Categorization of incidents into pre-preanalytical, preanalytical, analytical, postanalytical, and post-postanalytical phases.
• Analysis of incident causes, frequency, and resolution times.

Main Results:

• A total of 5185 incidents were collected, with 84.1% occurring in the pre-preanalytical phase, primarily due to missing or incorrect request form information (64.1%).
• Specific incidents within the biomarker testing process showed higher rates in the analytical (33.5%) and postanalytical (23.6%) phases.
• Pre-preanalytical incidents were resolved significantly faster (mean 6 days) than those in the complete process (mean 60 days).

Conclusions:

• A wide variation exists in the number and scope of documented incidents across different institutes.
• Incomplete or incorrect information on request forms and final reports represents a significant source of errors.
• Targeted interventions focusing on the accuracy of pre-preanalytical data are crucial for enhancing patient safety in molecular oncology testing.