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

Background: Current laboratory risk management principles emphasize the importance of assessing laboratory quality control (QC) practices in terms of the risk of patient harm. Limited practical guidance or examples on how to do this are available.

Methods: The patient risk model described in a published laboratory risk management guideline was combined with a recently reported approach to computing the predicted probability of patient harm to produce a risk management index (RMI) that compares the predicted probability of patient harm for a QC strategy to the acceptable probability of patient harm based on the expected severity of harm caused by an erroneously reported patient result.