Accuracy in clinical laboratories participating in regional quality control programs

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Quality Control

Background:

• Analytic bias (accuracy) in clinical chemistry laboratories is understudied.
• Quality control programs are essential for maintaining laboratory accuracy.

Purpose of the Study:

• To assess the analytic bias of participant "all-methods" results and individual methods for key analytes.
• To evaluate the agreement between "all-methods" results and established benchmark methods.

Main Methods:

• Utilized a six-year dataset from a large regional quality control program.
• Compared participant "all-methods" results and individual methods against United States Bureau of Standards definitive methods and/or United States Centers for Disease Control clinical reference methods.
• Analyzed bias for calcium, cholesterol, glucose, potassium, and sodium at clinically relevant levels.

Main Results:

• "All-methods" bias was found to be +0.1% for calcium, -0.7% for cholesterol, +4.5% for glucose, +0.5% for potassium, and 0% for sodium at specified concentrations.
• Sufficient agreement was observed between benchmark and "all-methods" results for these analytes.

Conclusions:

• "All-methods" results demonstrate acceptable analytic bias when compared to definitive and reference methods.
• "All-methods" results can serve as effective analytic bias benchmarks in future regional quality control programs.
• The findings support the reliability of aggregated laboratory data for assessing accuracy.