Organização do biorrepositório de amostras de pele e nervos humanos do Laboratório de Hanseníase, Instituto Oswaldo Cruz, Fundação Oswaldo Cruz, Rio de Janeiro, Brasil, em conformidade com o sistema da qualidade

• Autor(a) principal: Ferreira, Helen
• Data de Publicação: 2016
• Tipo de documento: Dissertação
• Idioma: por
• Título da fonte: Biblioteca Digital de Teses e Dissertações da UERJ
• Texto Completo: http://www.bdtd.uerj.br/handle/1/15019
• topic: Biorepository; Biobank; Organization of Human Biological Samples; Samples Cryopreservation; Biorrepositório; Biobanco; Organização de amostras biológicas humanas; Criopreservação de amostras.; Bancos de tecidos; Bancos de espécimes biológicos Normas; Bancos de Espécimes Biológicos Normas; Bancos de espécimes biológicos Legislação e Jurisprudência; Laboratórios Administração e organização; Armazenamento de materiais e provisões; Consentimento livre e esclarecido Ética; Consentimento livre e exclarecido Ética; CNPQ::CIENCIAS BIOLOGICAS

In recent years, regulation of biobanks and biorepositories of human biological samples became essential, leading research and assistance institutions to suit the standards of ethical conduct, legality and operation. This study deals with technical and operational organization of a biorepository for human skin and nerves samples of the Laboratório de Hanseníase, Instituto Oswaldo Cruz, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.The main goal is to meet national guidelines and the institutional policy of quality systems for laboratories, as well as compose the network biobanks Fiocruz. The study was conducted based on the standard technical requirements of quality and safety ISO 15189: 2015. Samples are collected in biopsies from patients treated in the Souza Araújo Ambulatory, an assistance area of Laboratório de Hanseníase after obtaining a informed consent term, intended to aid in the diagnosis and treatment of leprosy, and also in the research projects. Samples are collected, identified and neatly stored in containers with liquid nitrogen and their associated technical information form a database created in the 2010 version Access® software. Operating procedures (SOPs) were developed and implemented in order to standardize the receiving, identification and samples storage, as well as the maintenance of the containers system. The database allows the generation of indicators that show the profile of the samples stored in biorepository, considering the number of positive cases, classification, location of all samples from each patient, and control of the material for use in diagnosis or in the project. It is estimated that, with the system standardization, the biorepository may provide adequate samples with accessible technical and traceable information to the studies, producing reliable and reproducible results, in accordance with the requirements of external regulatory agencies and the need to publish in scientific journals with high impact factor. This work contributes to the biorepository certification, and continual improvement of the scientific quality of the projects developed in the Laboratório de Hanseníase.