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Publication
Gestão da análise metrológica em serviços de sangue e de medicina transfusional
| Name: | Description: | Size: | Format: | |
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| 18.68 MB | Adobe PDF |
Abstract(s)
Os requisitos-técnicos do sangue humano e componentes sanguíneos estão estabelecidos no regime jurídico nacional por transposição de Diretivas Europeias, visando a regulação e segurança pós-transfusional, nomeadamente através da implementação de sistemas de gestão da qualidade em Serviços de Sangue e Medicina Transfusional. O guia EDQM recomenda a implementação de práticas metrológicas para os dispositivos clínicos, onde se inserem os recursos de monitorização e medição. A maioria destes serviços, possuem abordagens de gestão certificadas segundo o referencial ISO 9001, que requer a análise metrológica dos recursos de monitorização e medição críticos para a conformidade da produção e conservação dos componentes sanguíneos. Constata-se, contudo, que as abordagens assentes em boas práticas de gestão metrológica carecem de implementação devidamente sistematizada. Os sistemas de gestão da qualidade implementados, devem ser sistemas que combinem critérios metrológicos, regulatórios, clínicos e orçamentais. Com esta dissertação, pretende-se discutir e sugerir um modelo para a gestão da análise metrológica, replicável em Serviços de Sangue e de Medicina Transfusional, baseado em boas práticas, que procurará ser eficiente favorecendo a autonomia parcial da análise metrológica por meios dos próprios serviços, sendo consistente com a regulação e requisitos normativos em vigor. Para a operacionalização deste modelo e ações subsequentes foram desenvolvidos fluxogramas para análise metrológica; por via de ensaio ou de calibração; de alguns dos recursos de monitorização e medição utilizados por estes serviços, e mediante os quais os requisitos metrológicos possam ser verificados de acordo com a adequação ao uso.
Abstract The technical requirements for human blood and blood components are established in the national legal system by transposition of European Directives to regulate and post-transfusion safety through implementing quality management systems in Blood Services and Transfusion Medicine. The EDQM guide recommends implementing metrological practices for clinical devices, including measurement and monitoring resources. Most of these services have management approaches certified according to the ISO 9001 standard, which requires the metrological analysis of the measuring and monitoring resources critical to the conformity of the production and conservation of blood components. However, the approaches based on good metrological management practices must be systematized appropriately. Implementing quality management systems must combine metrological, regulatory, clinical, and budgetary criteria. This dissertation aims to discuss and suggest a management model for metrological analysis, replicable in the Blood and Transfusion Medicine Services, based on good practices, which will seek to be efficient by favoring the partial autonomy of metrological analysis by the services themselves while being consistent with the regulatory and normative requirements in force. Flowcharts have been developed for the metrological analysis to operationalize this model and the subsequent actions, by test or calibration, of some of the measuring and monitoring resources, through which the metrological requirements can be verified according to their fitness for use.
Abstract The technical requirements for human blood and blood components are established in the national legal system by transposition of European Directives to regulate and post-transfusion safety through implementing quality management systems in Blood Services and Transfusion Medicine. The EDQM guide recommends implementing metrological practices for clinical devices, including measurement and monitoring resources. Most of these services have management approaches certified according to the ISO 9001 standard, which requires the metrological analysis of the measuring and monitoring resources critical to the conformity of the production and conservation of blood components. However, the approaches based on good metrological management practices must be systematized appropriately. Implementing quality management systems must combine metrological, regulatory, clinical, and budgetary criteria. This dissertation aims to discuss and suggest a management model for metrological analysis, replicable in the Blood and Transfusion Medicine Services, based on good practices, which will seek to be efficient by favoring the partial autonomy of metrological analysis by the services themselves while being consistent with the regulatory and normative requirements in force. Flowcharts have been developed for the metrological analysis to operationalize this model and the subsequent actions, by test or calibration, of some of the measuring and monitoring resources, through which the metrological requirements can be verified according to their fitness for use.
Description
Trabalho Final de Mestrado para obtenção do grau de Mestre em Engenharia da Qualidade e Ambiente
Keywords
Análise metrológica Incerteza Medição Monitorização Transfusão Measurement Metrological analysis Monitoring Transfusion Uncertainty