Internal quality control: best practice

Area of Science:

• Clinical Biochemistry
• Laboratory Medicine
• Quality Management

Background:

• Internal quality control (IQC) implementation and review vary widely in laboratory practice.
• Ineffective IQC can lead to incorrect patient result validation or unnecessary rejection of analytical runs.

Purpose of the Study:

• To provide a practical approach for clinical biochemistry laboratories to implement an efficient IQC system.
• To optimize error detection and minimize false rejections in routine laboratory operations.

Main Methods:

• Consideration of each IQC system stage: material selection, rule selection, and post-rejection actions.
• Grouping assays based on performance to assign appropriate IQC rules.
• Utilizing tools to categorize assay performance for IQC rule assignment.

Main Results:

• Assay-specific IQC systems reduce inappropriate sample-run rejections compared to universal rules.
• A limited number of IQC rules (3-4) are sufficient for routine biochemistry assays when grouped by performance.
• Implementation requires time and education but yields significant cost and labor reductions.

Conclusions:

• An optimized IQC system ensures day-to-day analytical consistency and reliable patient result release.
• Tailoring IQC rules to specific analyte performance is more effective than a one-size-fits-all approach.
• Strategic implementation of IQC leads to substantial operational efficiencies and cost savings.