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Background-aim. The patient-centered evaluation of pre-analytical errors through risk management based on the implementation of harmonized quality indicators (QIs) is an important tool used for pre-analytical quality improvement and patient safety. The aim of this study was to assess the impact of phlebotomy educational activities based on the ISO 15189 requirements and the National recommendations for venous and capillary blood sampling using the Failure Mode and Effects Analysis (FMEA). Methods. From January to December 2018 in the Department of Medical Biochemistry and Laboratory Medicine an retrospective observation analysis of QIs as part of the model of quality indicators (MQIs) was applied. MQI launched by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on „Laboratory Errorrs and Patient Safety” (WG-LEPS) with highest risk priority numbers (RPNs) included followed QIs: Percentage of Number of misidentified samples/Total number of samples (PreMisS), Precentage of Number of samples with free haemoglobin (Hb < 0, 5 g/L) detected by visual inspection/Total number of checked samples for haemolysis (Pre-HemV), Precentage of Number of samples not received/Total number of samples (Pre-NotRec). RPNs before and after QIs implementation of phlebotomy educational activities were calculated and compared to baseline. The goal was to decrease the RPNs at least by 10% from those last year. Results. During a year 1900680 requests and 543828 venous and capillary blood samples were considered. After implementation of harmonized QIs as a part of the patient-centered evaluation of pre-analytical errors their number decreased from 2472 (2017) to 2212 (2018) with the highest rates for Pre-HemV (0, 47%), Pre-Clot (0, 27%), Pre-NotRec (0, 13%) and Pre-MisS (0, 03%) with 4.1, 4.3, 4.6 and 5.0 Six Sigma values respectively. Reevaluated RPNs for hemolized (96 to 72), clotted(72 to 54) and unreceived (16 to 12) samples decreased by 13%, but for misidentification errors did not changed (81 to 81). Conclusions. Phlebotomy educational activities based on the ISO 15189 requirements and the National recommendations as well as implementation of harmonized QIs decreased the number of pre-analytical errors and improved the laboratory pre-analytical process, but the need for risk management based on improving the misidentification errors still exsists. |
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