Performance specifications for the extra-analytical phases of laboratory testing: Why and how

Area of Science:

• Clinical Laboratory Science
• Healthcare Quality Improvement
• Diagnostic Error Reduction

Background:

• Laboratory testing errors contribute significantly to overall diagnostic errors in healthcare.
• Past efforts focused on technology and test accuracy but overlooked the comprehensive total testing process (TTP).
• Current data emphasize the need to reassess the TTP for enhancing quality and patient safety.

Purpose of the Study:

• To highlight the importance of quality indicators (QIs) and extra-analytical performance specifications for improving the TTP.
• To address the lack of literature on outcome-based extra-analytical specifications and biological variability calculations.
• To initiate data collection for establishing the state-of-the-art in laboratory quality indicators.

Main Methods:

• Reviewing existing literature on laboratory quality indicators and the total testing process.
• Identifying the need for standardized data collection and reporting methods for QIs.
• Initiating a data collection process to establish current benchmarks for QIs.

Main Results:

• The total testing process (TTP) requires re-evaluation for quality and patient safety improvements.
• There is a lack of established extra-analytical performance specifications based on outcomes or biological variability.
• Data collection for quality indicators is currently underway to establish a state-of-the-art baseline.

Conclusions:

• A harmonized set of QIs, standardized data collection, and reporting are mandatory for clinical laboratory accreditation.
• Implementing standardized QIs will guide improvement processes and ensure quality patient care.
• Focusing on the entire TTP, including extra-analytical phases, is vital for reducing diagnostic errors.