The Application of Six Sigma to Assess the Analytical Performance of Plasma Proteins and Design a Risk-Based...

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Quality Management

Background:

• Evaluated plasma protein testing performance across six laboratories using the Six Sigma model.
• Implemented customized quality control programs and targeted improvements based on performance data.

Purpose of the Study:

• To apply the Six Sigma model for objective evaluation of plasma protein testing performance.
• To develop and implement customized, risk-based statistical quality control strategies.

Main Methods:

• Collected Internal Quality Control (IQC) and External Quality Assessment (EQA) data for plasma proteins.
• Calculated Sigma values using coefficient of variation (CV), bias, and total allowable error (TEa).
• Utilized Six Sigma performance charts, Westgard rules, and Quality Goal Index (QGI) to develop laboratory-specific quality control schemes.

Main Results:

• Observed significant inter-laboratory variation in Sigma values despite standardized methods.
• Identified performance variations within laboratories across different analyte concentrations.
• Achieved marked performance improvements through tailored quality control for Sigma values below 6.

Conclusions:

• The Six Sigma model offers an objective framework for assessing and enhancing plasma protein test quality.
• Facilitates quantitative evaluation of laboratory management and supports customized SQC strategies.
• Enables targeted improvements in multi-laboratory systems through risk-based quality control.