Ensuring internal quality control practices in medical Laboratories: IFCC recommendations for practical applications...

Area of Science:

• Medical Laboratory Science
• Quality Management Systems
• Diagnostic Accuracy

Background:

• Medical laboratories require robust internal quality control (IQC) strategies for accreditation.
• ISO 15189:2022 provides updated standards for laboratory quality and competence.
• Effective IQC is essential for ensuring reliable diagnostic results and patient safety.

Purpose of the Study:

• To provide guidance on implementing and monitoring an IQC strategy aligned with ISO 15189:2022.
• To offer practical, user-friendly resources for laboratory professionals.
• To enhance diagnostic reliability through a risk-based approach to IQC.

Main Methods:

• Following the structure and content of the ISO 15189:2022 Standard.
• Applying a risk-based approach to IQC processes for quantitative results.
• Discussing specific IQC aspects: material selection, control frequency, limits, statistical rules, comparability, non-conformities, quality indicators, and uncertainty.

Main Results:

• Detailed discussion on selecting IQC materials and defining control parameters.
• Strategies for applying statistical rules and handling deviations from acceptable limits.
• Integration of IQC into the accreditation process, focusing on risk identification and mitigation.

Conclusions:

• Implementing a comprehensive IQC strategy is crucial for ISO 15189:2022 compliance.
• A risk-based approach enhances the effectiveness of IQC in medical laboratories.
• Proactive risk management in IQC directly contributes to improved patient safety.