Risk analysis of the preanalytical process based on quality indicators data.

Background: Improving quality and patient safety in the medical biochemistry laboratory accredited according to the International Standard Organization (ISO 15189:2012) requires the patient-centered evaluation of errors based on the implementation of quality indicators (QIs) across the total testing process. Our main goal was to achieve quality improvement of the preanalytical process in an emergency laboratory which had the highest error rate using risk management principles.

Methods: Failure mode and effects analysis (FMEA) was applied to analyze predefined preanalytical QIs and score laboratory failures for the failure demerit value (FDV), probability of failure (PF) and probability of failure remedy (PFR). Based on obtained scores (on a 10-point scale) risk priority numbers (RPNs) were calculated.

Results: A total of five failure modes were identified in the preanalytic process. The calculated risks were "sample hemolysis" (RPN, 168),"misidentified samples" (RPN, 108),"samples clotted" (RPN, 90),"sample volume error" (RPN, 72) and "samples transported at inappropriate temperature" (RPN, 24). The activation of corrective risk-reducing measures for failure modes with RPN≥30 resulted in quality improvement with the significant decrease in reevaluated RPNs.

Conclusions: The implementation of a preanalytical quality monitoring system based on observation of evidence-based QIs and patient-centered evaluation of errors through risk analysis with regular tailored education as well as implementing process improvements can effectively reduce preanalytical errors in the emergency laboratory and improve patient safety.