Verification of Assayed Blood Gas Quality Control Ranges.

Area of Science:

• Clinical Laboratory Science
• Medical Diagnostics
• Analytical Chemistry

Background:

• Blood gas quality control (QC) is a mandatory laboratory process.
• Laboratories must verify manufacturer-provided QC ranges, a Clinical Laboratory Improvement Amendment (CLIA) requirement.
• Acceptable QC ranges are typically 2 standard deviations (SD) from the mean.

Purpose of the Study:

• To verify the mean and 2 SD ranges of QC measurements from a blood gas analyzer.
• To assess the agreement between laboratory-measured QC data and manufacturer-provided data.
• To evaluate the clinical acceptability of manufacturer-provided QC ranges.

Main Methods:

• Compared QC data from a blood gas analyzer to manufacturer-provided mean and ranges.
• Calculated the percent difference between measured and manufacturer-provided mean values.
• Determined how many SD the manufacturer ranges were from the measured mean using measured SD.

Main Results:

• The largest mean value difference was 2.27% above the manufacturer mean.
• 48% of mean comparisons showed 0% difference, and 71% were less than 1%.
• Manufacturer ranges (2.4-75 SD) were significantly wider than measured 2 SD ranges and deemed unacceptable for clinical use.

Conclusions:

• Analysis validates the CLIA mandate for QC range verification.
• Laboratories must verify and adjust QC means and ranges to match their specific blood gas analyzer's performance.
• This ensures accurate and reliable blood gas testing in clinical settings.