engleski

Improving clinical outcome - risk management of the preanalytical process in the ISO 15189 accredited medical biochemistry laborator

Background: Improving quality and patient safety in the medical biochemistry laboratory accredited according to the International Standard (ISO 15189:2012) requires patient-centred evaluation of errors based on implementation of quality indicators (QIs) across the total testing process. Our main goal was risk management of the preanalytical process in a emergency laboratory which had the highest error rate. Methods:. Failure Mode and Effects Analysis (FMEA) was applied to analyse predefined preanalytical QIs and score laboratory failures for the Failure Demerit Value (FDV) Probabality of Failure(FDV) and Probabability of Failure Remedy (PFR). Based on obtained scores (on a 10-point scale) risk priority numbers (RPNs) were calculated. Results: A total of 5 failure modes were identified in the pre-analytic phase. The calculated risks were "sample hemolysis" (RPN, 168), " misidentified samples" (RPN, 162), " 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 significant decrease in reevaluated RPNs. Conclusions: Observation of evidence–based QIs and patient-centred evaluation of errors through risk analysis with regular tailored education can effectively reduce preanalytical errors in emergency laboratory and improve clinical outcome.

patient outcome; risk management; FMEA; preanalytical process; quality indicators

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