Are definitive (reference) methods and Shewhart's principle the best approach towards accuracy?

Area of Science:

• Clinical Chemistry
• Analytical Chemistry
• Quality Control

Background:

• Current quality control in clinical chemistry is deemed acceptable, necessitating improvement.
• Analytical deficiencies in clinical chemistry methods are highlighted, influenced by sample matrices.
• Over-reliance on statistical methods in quality control is criticized.

Purpose of the Study:

• To evaluate the current state of quality control in clinical chemistry.
• To identify deficiencies in analytical methods and statistical applications.
• To propose improvements for quality control based on historical principles.

Main Methods:

• Analysis of results from quality control programs.
• Critique of statistical methods in quality control.
• Discussion of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method definition.

Main Results:

• Quality control in clinical chemistry is currently only acceptable, not optimal.
• Matrix effects reveal significant analytical deficiencies in current methods.
• Defining definitive methods is challenging due to indeterminate accuracy and true values.

Conclusions:

• Improving analytical method accuracy and precision is crucial for effective quality control.
• The principles of Shewhart's quality control from industry, focusing on eliminating variation sources, should guide clinical chemistry.
• A shift from statistical over-reliance to enhanced analytical performance is recommended for robust quality control.