Evaluation of Pre-Analytical Performance Using IFCC Quality Indicators, Six Sigma Metrics and Root Cause Analysis in...

Area of Science:

• Clinical Biochemistry
• Laboratory Medicine
• Quality Management in Healthcare

Background:

• Pre-analytical errors constitute the majority of failures in the total testing process.
• Evaluating pre-analytical performance is crucial for laboratory quality assurance.
• This study focuses on a tertiary-care biochemistry laboratory in Riyadh, Saudi Arabia.

Purpose of the Study:

• To evaluate pre-analytical performance using IFCC-aligned Quality Indicators (QIs) and Six Sigma metrics.
• To identify root causes of pre-analytical errors through structured Root Cause Analysis (RCA).
• To provide data-driven recommendations for quality improvement in a clinical biochemistry setting.

Main Methods:

• Retrospective analysis of biochemistry tests performed between January and December 2024.
• Classification of rejected tests into seven IFCC-aligned QI categories.
• Application of Six Sigma metrics, Pareto analysis, and Ishikawa-based RCA.

Main Results:

• An overall rejection rate of 1.28% (10,783/845,647 tests) was observed, with an overall process capability of 3.89σ.
• Hemolysis was the leading cause of rejection (75.92%), with a performance of 3.97σ.
• Hemolysis and inappropriate tube use were identified as the primary issues, responsible for 83.52% of rejections.

Conclusions:

• The laboratory's overall rejection rate is comparable to international benchmarks.
• Hemolysis represents the main process vulnerability, followed by inappropriate tube selection.
• Recommendations include enhanced phlebotomy training, real-time hemolysis feedback, and targeted interventions for the Emergency Department.