Diagnostic Errors and Laboratory Medicine - Causes and Strategies

Area of Science:

• Clinical Laboratory Science
• Quality Management in Healthcare

Background:

• Laboratory errors vary significantly based on study design and the total testing process (TTP) phases examined.
• Recent research highlights increased vulnerability to errors in the pre- and post-analytical phases compared to the analytical phase.
• Pre-pre- and post-post-analytical steps, often outside direct laboratory control, show a high frequency of errors with potential patient harm.

Purpose of the Study:

• To review the evolving understanding of laboratory errors.
• To emphasize the significance of the pre- and post-analytical phases in laboratory testing.
• To highlight the impact of a patient-centered approach to laboratory errors.

Main Methods:

• Review of published papers over the last two decades.
• Analysis of error frequency across different phases of the total testing process (TTP).
• Consideration of the influence of international standards on laboratory error management.

Main Results:

• The pre- and post-analytical phases are identified as more error-prone than the analytical phase.
• Significant errors and risks to patients are noted in pre-pre- and post-post-analytical steps.
• The International Organization for Standardization's Technical Specification (ISO/TS 22367) has been pivotal in shifting perspectives.

Conclusions:

• Laboratory error management requires a focus beyond the traditional analytical phase.
• A patient-centered approach is essential for improving the safety and reliability of laboratory testing.
• The ISO/TS 22367 standard promotes a comprehensive view of laboratory quality and error reduction.