Assessing Quality Control Strategies for HbA1c Measurements From a Patient Risk Perspective.

Area of Science:

• Clinical Laboratory Science
• Patient Safety
• Risk Management

Background:

• Current laboratory risk management emphasizes assessing quality control (QC) for patient harm risk.
• Practical guidance and examples for this assessment are limited.

Purpose of the Study:

• To develop and demonstrate a method for directly correlating laboratory QC practices with the risk of patient harm.
• To provide a concrete example of risk assessment in laboratory quality control.

Main Methods:

• Combined a patient risk model with an approach to compute the predicted probability of patient harm.
• Developed a risk management index (RMI) to compare predicted vs. acceptable harm probabilities.
• Assessed QC performance for two HbA1c instruments using the RMI.

Main Results:

• The risk management index (RMI) was computed for individual instruments and the laboratory overall.
• The assessment demonstrated the direct correlation between QC practices and patient harm risk.
• Provided a practical example of applying risk assessment to laboratory QC.

Conclusions:

• The developed RMI offers a concrete method for evaluating laboratory QC in terms of patient harm risk.
• This approach enhances the practical application of risk management principles in clinical laboratories.
• Directly links laboratory QC performance to patient safety outcomes.