Analytical performance assessment and improvement by means of the Failure mode and effect analysis (FMEA).
Biochem Med (Zagreb)
; 30(2): 020703, 2020 Jun 15.
Article
em En
| MEDLINE
| ID: mdl-32292281
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 ANDMETHODS:
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Sódio
/
Erros de Diagnóstico
/
Fosfatase Alcalina
/
Análise do Modo e do Efeito de Falhas na Assistência à Saúde
Tipo de estudo:
Diagnostic_studies
/
Etiology_studies
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article