IFCC recommendations for internal quality control practice: a missed opportunity.

Area of Science:

• Clinical Chemistry
• Laboratory Quality Management

Background:

• The IFCC Task Force on Global Lab Quality (TF-GLQ) issued new guidance for internal quality control (IQC) practice.
• This guidance translates ISO 15189:2022 principles into practical recommendations for laboratory professionals.
• The current guidance presents significant inaccuracies and shortcomings, hindering its utility.

Purpose of the Study:

• To critically analyze the IFCC TF-GLQ's new IQC guidance.
• To identify key inaccuracies and areas for improvement in the provided recommendations.
• To advocate for a more systematic, updated, and evidence-based approach to IQC guidance.

Main Methods:

• Critical review of the IFCC TF-GLQ's guidance document.
• Analysis of four specific issues: IQC design in the traceability era, defining acceptance limits, estimating measurement uncertainty from IQC data, and managing inter-analyzer comparability.
• Comparison with established principles and best practices in laboratory quality management.

Main Results:

• The IFCC TF-GLQ guidance contains critical inaccuracies and shortcomings.
• Specific issues identified include challenges in designing IQC strategies, defining acceptance limits, estimating measurement uncertainty, and ensuring inter-analyzer comparability.
• The current recommendations represent a missed opportunity for providing truly updated guidance.

Conclusions:

• A more systematic, updated, and evidence-based approach is essential for developing future IFCC IQC recommendations.
• Addressing the identified inaccuracies is crucial for enhancing the practical utility of IQC guidance for laboratory professionals.
• The findings underscore the need for rigorous evaluation of quality management guidelines to maintain the integrity of laboratory testing.