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Analytical performance assessment and improvement by means of the Failure mode and effect analysis (FMEA)

INTRODUCTION: Laboratories 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 t...

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Autores principales: Guiñón, Leonor, Soler, Anna, Gisell Díaz, Mónica, Fernández, Rosa María, Rico, Nayra, Bedini, Josep Lluís, Mira, Aurea, Alvarez, Luisa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Croatian Society of Medical Biochemistry and Laboratory Medicine 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7137999/
https://www.ncbi.nlm.nih.gov/pubmed/32292281
http://dx.doi.org/10.11613/BM.2020.020703
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author Guiñón, Leonor
Soler, Anna
Gisell Díaz, Mónica
Fernández, Rosa María
Rico, Nayra
Bedini, Josep Lluís
Mira, Aurea
Alvarez, Luisa
author_facet Guiñón, Leonor
Soler, Anna
Gisell Díaz, Mónica
Fernández, Rosa María
Rico, Nayra
Bedini, Josep Lluís
Mira, Aurea
Alvarez, Luisa
author_sort Guiñón, Leonor
collection PubMed
description INTRODUCTION: Laboratories 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 METHODS: The 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 (σ(FMEA)). A root-cause analysis was done when σ(FMEA) 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. RESULTS: The FMEA of 2017 showed that alkaline phosphatase (ALP) and sodium (Na) presented a σ(FMEA) of less than 3. The FMEA of 2018 revealed that none of the measurands presented a σ(FMEA) below 3 and that σ(FMEA) for ALP and Na had increased. CONCLUSIONS: Failure 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.
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spelling pubmed-71379992020-04-15 Analytical performance assessment and improvement by means of the Failure mode and effect analysis (FMEA) Guiñón, Leonor Soler, Anna Gisell Díaz, Mónica Fernández, Rosa María Rico, Nayra Bedini, Josep Lluís Mira, Aurea Alvarez, Luisa Biochem Med (Zagreb) Original Papers INTRODUCTION: Laboratories 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 METHODS: The 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 (σ(FMEA)). A root-cause analysis was done when σ(FMEA) 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. RESULTS: The FMEA of 2017 showed that alkaline phosphatase (ALP) and sodium (Na) presented a σ(FMEA) of less than 3. The FMEA of 2018 revealed that none of the measurands presented a σ(FMEA) below 3 and that σ(FMEA) for ALP and Na had increased. CONCLUSIONS: Failure 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. Croatian Society of Medical Biochemistry and Laboratory Medicine 2020-04-15 2020-06-15 /pmc/articles/PMC7137999/ /pubmed/32292281 http://dx.doi.org/10.11613/BM.2020.020703 Text en Croatian Society of Medical Biochemistry and Laboratory Medicine. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Papers
Guiñón, Leonor
Soler, Anna
Gisell Díaz, Mónica
Fernández, Rosa María
Rico, Nayra
Bedini, Josep Lluís
Mira, Aurea
Alvarez, Luisa
Analytical performance assessment and improvement by means of the Failure mode and effect analysis (FMEA)
title Analytical performance assessment and improvement by means of the Failure mode and effect analysis (FMEA)
title_full Analytical performance assessment and improvement by means of the Failure mode and effect analysis (FMEA)
title_fullStr Analytical performance assessment and improvement by means of the Failure mode and effect analysis (FMEA)
title_full_unstemmed Analytical performance assessment and improvement by means of the Failure mode and effect analysis (FMEA)
title_short Analytical performance assessment and improvement by means of the Failure mode and effect analysis (FMEA)
title_sort analytical performance assessment and improvement by means of the failure mode and effect analysis (fmea)
topic Original Papers
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7137999/
https://www.ncbi.nlm.nih.gov/pubmed/32292281
http://dx.doi.org/10.11613/BM.2020.020703
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