Risk analysis of the preanalytical process based on quality indicators data

Area of Science:

• Clinical Laboratory Science
• Medical Diagnostics
• Quality Management in Healthcare

Background:

• Accreditation to ISO 15189:2012 necessitates patient-centered error evaluation using quality indicators (QIs).
• Emergency laboratories often exhibit high error rates, particularly in the preanalytical phase.
• Risk management principles are crucial for improving laboratory quality and patient safety.

Purpose of the Study:

• To enhance the preanalytical process quality in an emergency laboratory.
• To reduce the highest error rates identified within the laboratory setting.
• To apply risk management principles for systematic error reduction.

Main Methods:

• Failure Mode and Effects Analysis (FMEA) was employed to assess preanalytical QIs.
• Laboratory failures were scored for failure demerit value (FDV), probability of failure (PF), and probability of failure remedy (PFR).
• Risk Priority Numbers (RPNs) were calculated based on these scores to quantify risk levels.

Main Results:

• Five key preanalytical failure modes were identified: sample hemolysis (RPN 168), misidentified samples (RPN 108), clotted samples (RPN 90), sample volume error (RPN 72), and improper sample transport temperature (RPN 24).
• Corrective actions targeting failures with RPN ≥ 30 led to significant quality improvements.
• Reevaluated RPNs demonstrated a substantial decrease, indicating effective risk reduction.

Conclusions:

• A preanalytical quality monitoring system utilizing evidence-based QIs and risk analysis is effective.
• Patient-centered error evaluation and tailored education are vital components.
• Implementing process improvements and risk analysis demonstrably reduces preanalytical errors and enhances patient safety in emergency laboratories.