Laboratory risk management for INR alert values.

Area of Science:

• Clinical Laboratory Science
• Medical Diagnostics
• Patient Safety

Background:

• The International Normalized Ratio (INR) is crucial for monitoring vitamin K antagonist therapy.
• Efficient management of laboratory INR alert values is essential for optimal patient care.
• Evaluating risk levels associated with INR alert values is vital for quality improvement in clinical laboratories.

Purpose of the Study:

• To assess the risk levels of International Normalized Ratio (INR) alert values in a tertiary care hospital's laboratory.
• To compare observed INR alert value risks with established benchmarks.
• To identify underlying causes and failure modes contributing to INR alert values.

Main Methods:

• Analysis of 42,799 plasma samples for INR values over a 12-month period (September 2023 - August 2024).
• Assessment of risk levels for INR values > 4.5 using a risk assessment matrix.
• Calculation of daily probability for INR alert value occurrence.
• Evaluation of the sample journey and documentation practices within the clinical laboratory.

Main Results:

• 347 out of 42,799 samples (0.81%) exhibited INR alert values (>4.5).
• INR alert values > 4.5 were classified as an unacceptable risk level due to high frequency (0.95 daily occurrence) and critical consequences.
• Potential failure modes included incomplete communication documentation and significant resampling delays (>6 hours in 30% of cases).

Conclusions:

• INR alert values > 4.5 represent a significant and unacceptable risk in the clinical laboratory setting.
• The study identified specific failure modes, such as documentation gaps and sample handling delays, that contribute to unacceptable INR values.
• Implementation of stringent control measures is recommended for laboratories to mitigate the risks associated with critical INR alert values.