Abstract
IntroductionLaboratories minimize risks through quality control but analytical errors still occur. Risk management can improve the quality of processes and increase patient safety. This study aims to use the failure mode and effect analysis (FMEA) to assess the analytical performance and measure the effectiveness of the risk mitigation actions implemented.Materials and methodsThe measurands to be included in the study were selected based on the measurement errors obtained by participating in an External Quality Assessment (EQA) Scheme. These EQA results were used to perform an FMEA of the year 2017, providing a risk priority number that was converted into a Sigma value (σFMEA). A root-cause analysis was done when σFMEA was lower than 3. Once the causes were determined, corrective measures were implemented. An FMEA of 2018 was carried out to verify the effectiveness of the actions taken.ResultsThe FMEA of 2017 showed that alkaline phosphatase (ALP) and sodium (Na) presented a σFMEA of less than 3. The FMEA of 2018 revealed that none of the measurands presented a σFMEA below 3 and that σFMEA for ALP and Na had increased.ConclusionsFailure mode and effect analysis is a useful tool to assess the analytical performance, solve problems and evaluate the effectiveness of the actions taken. Moreover, the proposed methodology allows to standardize the scoring of the scales, as well as the evaluation and prioritization of risks.
Highlights
Laboratories minimize risks through quality control but analytical errors still occur
In the last few years it has been found that most of the laboratory errors occur in the extra-analytical phases. This is because the vast majority of the strategies adopted to minimize risks have been focused on reducing failures in the analytical phase, such as the design of an internal quality control (IQC) plan or the participation in external quality assessment (EQA) schemes [3]
Alkaline phosphatase and Na presented a σFMEA of less than 3 and only CK was close to the world-class quality
Summary
Laboratories minimize risks through quality control but analytical errors still occur. In the last few years it has been found that most of the laboratory errors occur in the extra-analytical phases This is because the vast majority of the strategies adopted to minimize risks have been focused on reducing failures in the analytical phase, such as the design of an internal quality control (IQC) plan or the participation in external quality assessment (EQA) schemes [3]. Despite these strategies, nowadays the estimated percentage of analytical errors is approximately 23% of the total errors produced in laboratories [4]. This indicates that it is necessary to improve analytical performance, efforts to mitigate these errors should not cease
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