Risk analysis of the preanalytical process based on quality indicators data

Clinical Chemistry and Laboratory Medicine - Tập 55 Số 3 - 2017
Zlata Flegar-Meštrić1, Sonja Perkov2, Andrea Radeljak2, Mirjana Marijana Kardum Paro2, Ingrid Prkačin3, Ana Devčić-Jeras4
1Department of Medical Biochemistry and Laboratory Medicine, "Merkur" University Hospital, 10 000 Zagreb, Zajčeva 19, Croatia, Phone/Fax: +385 1 2431 397
2Department of Medical Biochemistry and Laboratory Medicine, University Hospital Merkur, Zagreb, Croatia
3Department of Internal Medicine, University Hospital Merkur, Zagreb, Croatia
4Department of Integrated Management System, Andrija Štampar, Teaching Institute of Public Health, Zagreb, Croatia

Tóm tắt

AbstractBackground: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.

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Tài liệu tham khảo

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2014, Harmonization of pre-analytical quality indicators, Biochem Med, 24, 105

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2013, Inpatient preanalytic process improvements, Arch Pathol Lab Med, 137, 1753, 10.5858/arpa.2012-0458-OA

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2014, Quality indicators to detect pre-analytical errors in laboratory testing, Clin Chim Acta, 15, 44

2015, Capillary blood sampling: national recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Biochem Med (Zagreb), 25, 335

2014, Practical, transparent prospective risk analysis for the clinical laboratory, Ann Clin BiochemBiochem, 51, 695, 10.1177/0004563214521160

2016, Working Group for Preanalytical Phase (WG-PRE), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Patient identification and tube labelling – a call for harmonisation, Clin Chem Lab Med, 54, 1141

2013, Quality indicators in laboratory medicine: a fundamental tool for quality and patient safety, Clin Biochem, 46, 1170, 10.1016/j.clinbiochem.2012.11.028

2009, The reporting, classification and grading of Quality failures in the medical laboratory, Clin Chim Acta, 404, 28, 10.1016/j.cca.2009.03.023

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Clinical Chemistry and Laboratory Medicine

Tập 55 Số 3

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