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Aplicação da Metodologia Seis Sigma na Avaliação Externa da Qualidade de Laboratórios Clínicos dos Parâmetros Colesterol Total, Colesterol LDL e Triglicéridos
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Resumo(s)
A monitorização do Colesterol, Colesterol LDL e Triglicéridos revela-se importante, já que níveis
elevados destes parâmetros estão frequentemente associados a doenças cardiovasculares. Assim,
torna-se fundamental garantir a qualidade dos exames laboratoriais que os incluam e é neste âmbito
que se desenvolve a presente dissertação.
Avaliando os resultados de programas de avaliação externa da qualidade, é possível verificar a
variabilidade presente nos resultados interlaboratoriais. A harmonização e normalização pretendem
minimizar as diferenças entre os resultados de diferentes laboratórios e contribuir para melhorar a
qualidade e prestar um melhor serviço. Este é um dos objetivos do Programa Nacional de Avaliação
Externa da Qualidade (PNAEQ), inserido no Departamento de Epidemiologia do Instituto Nacional de
Saúde Doutor Ricardo Jorge (INSA, I.P.).
O estudo de caso teve como recurso principal a metodologia Seis Sigma e a estrutura do método
DMAIC (Define, Measure, Analyze, Improve, Control) com as respetivas ferramentas da qualidade para
avaliar e melhorar o nível da qualidade Sigma apresentado pelos laboratórios participantes do programa
de Química Clínica em relação aos parâmetros estudados. Foi utilizada a medida Bias para medir a
variabilidade dos resultados do período de 2018 a 2020. Também foi realizado um estudo
complementar para analisar a estabilidade das amostras de controlo e compreender se contribui de
forma relevante para a qualidade dos resultados.
Após definir claramente projeto, os dados foram tratados estatisticamente tendo sido definido o estado
atual calculando o nível da qualidade Sigma por parâmetro e ano. Foram então analisadas possíveis
causas de uma qualidade inferior à desejada e desenvolvidas medidas de melhoria para aumentar o
nível da qualidade Sigma. Foram implementadas as medidas e realizado um teste piloto para verificar
a eficácia das mesmas, sendo que não se identificaram melhorias consistentes. Foi ainda desenvolvido
um plano de controlo contendo medidas que contribuirão para melhorar a qualidade dos resultados dos
laboratórios participantes.
It’s fundamental to monitor Cholesterol, LDL Cholesterol and Triglycerides as high levels of these analytes are commonly associated with cardiovascular diseases. Thus, it’s essential to guarantee the quality of laboratory tests that include these parameters, and this dissertation is developed within this scope. When evaluating the results of external quality assessment programs, it’s possible to identify the variability present in the interlaboratory results. Harmonization and standardization aim to minimize the differences in results from distinct laboratories and contribute to a quality improvement of the service. This presents as one of the goals of the Programa Nacional de Avaliação Externa da Qualidade (PNAEQ), which is part of the Department of Epidemiology of the Instituto Nacional de Saúde Doutor Ricardo Jorge (INSA, I.P.). The main purpose of the case study was to use the Six Sigma methodology and the structure of the DMAIC (Define, Measure, Analyse, Improve, Control) method complemented by quality tools to assess and improve the Sigma quality level presented by the participating laboratories of the Clinical Chemistry program regarding the chosen parameters. Bias was the measure used to quantify the variability of the results from 2018 to 2020. A complementary study was also carried out to analyse the stability of the control samples and ascertain if it contributes in a relevant way to the quality of the results. After clearly defining the project, the data was processed, and the current situation defined by calculating the Sigma quality level by parameter and year. Possible causes of lower quality than desired were analysed and improvement measures were developed and implemented to increase the Sigma quality level. A pilot test was performed to verify their effectiveness, but it wasn’t possible to identify consistent improvements. A control plan was also developed, containing measures to achieve a better quality level by the participating laboratories.
It’s fundamental to monitor Cholesterol, LDL Cholesterol and Triglycerides as high levels of these analytes are commonly associated with cardiovascular diseases. Thus, it’s essential to guarantee the quality of laboratory tests that include these parameters, and this dissertation is developed within this scope. When evaluating the results of external quality assessment programs, it’s possible to identify the variability present in the interlaboratory results. Harmonization and standardization aim to minimize the differences in results from distinct laboratories and contribute to a quality improvement of the service. This presents as one of the goals of the Programa Nacional de Avaliação Externa da Qualidade (PNAEQ), which is part of the Department of Epidemiology of the Instituto Nacional de Saúde Doutor Ricardo Jorge (INSA, I.P.). The main purpose of the case study was to use the Six Sigma methodology and the structure of the DMAIC (Define, Measure, Analyse, Improve, Control) method complemented by quality tools to assess and improve the Sigma quality level presented by the participating laboratories of the Clinical Chemistry program regarding the chosen parameters. Bias was the measure used to quantify the variability of the results from 2018 to 2020. A complementary study was also carried out to analyse the stability of the control samples and ascertain if it contributes in a relevant way to the quality of the results. After clearly defining the project, the data was processed, and the current situation defined by calculating the Sigma quality level by parameter and year. Possible causes of lower quality than desired were analysed and improvement measures were developed and implemented to increase the Sigma quality level. A pilot test was performed to verify their effectiveness, but it wasn’t possible to identify consistent improvements. A control plan was also developed, containing measures to achieve a better quality level by the participating laboratories.
Descrição
Palavras-chave
Seis Sigma Método DMAIC Ferramentas da Qualidade Avaliação Externa da Qualidade Laboratório Clínico PNAEQ