Original scientific paper

https://doi.org/10.11613/BM.2020.020703

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

Leonor Guiñón ; Quality Department, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Barcelona, Spain
Anna Soler ; Quality Department, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Barcelona, Spain
Mónica Gisell Díaz ; Quality Department, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Barcelona, Spain
Rosa María Fernández ; Biochemistry and Molecular Genetics Department, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Barcelona, Spain
Nayra Rico ; Biochemistry and Molecular Genetics Department, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Barcelona, Spain
Josep Lluís Bedini ; Biochemistry and Molecular Genetics Department, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Barcelona, Spain
Aurea Mira ; Direction, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Barcelona, Spain
Luisa Alvarez ; Quality Department, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Barcelona, Spain

Abstract

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 (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.
Results: The 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.
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.

Keywords

risk management; FMEA; sigma metric; analytical performance; quality control

Hrčak ID:

238906

URI

https://hrcak.srce.hr/238906

Publication date:

15.6.2020.

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