An external quality assessment scheme for total bilirubin

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Quality Assurance

Background:

• Accurate total bilirubin measurement is critical for diagnosing and monitoring conditions like jaundice.
• Existing quality assessment schemes may lack timely feedback or comprehensive performance metrics.
• Standardization of bilirubin assays across laboratories is essential for reliable patient care.

Purpose of the Study:

• To describe a novel regional quality assessment scheme for total bilirubin methods.
• To evaluate the stability of liquid sera materials used in the assessment.
• To introduce innovative data presentation for rapid and informative participant feedback.

Main Methods:

• Development of a quality assessment scheme utilizing liquid sera at three distinct concentrations.
• Assessment of serum material stability over the evaluation periods.
• Implementation of a feedback system providing weekly deviation reports and 6-monthly performance summaries.
• Facilitation of participant dialogue regarding all scheme aspects.

Main Results:

• The liquid sera demonstrated adequate stability for the assessment periods.
• The scheme successfully provided quick feedback on comparative performance within and between laboratories.
• Novel data presentation included weekly deviation from weighed-in values and intra/inter-laboratory variation.
• A 6-monthly summary reported achievable precision based on the best-performing laboratories.

Conclusions:

• The described quality assessment scheme is effective for evaluating total bilirubin methods.
• The scheme's stability, rapid feedback, and novel data reporting enhance laboratory performance monitoring.
• Continuous dialogue with participants ensures scheme relevance and material suitability.