DECRETO Nº 95721, DE 11 DE FEVEREIRO DE 1988. Regulamenta a Lei 7.649, de 25 de Janeiro de 1988, que 'estabelece a Obrigatoriedade do Cadastramento Dos Doadores de Sangue Bem Como a Realização de Exames Laboratoriais No Sangue Coletado, Visando a Prevenir a Propagação de Doenças'.
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DECRETO N° 95.721, DE 11 DE FEVEREIRO DE 1988
Regulamenta a Lei n° 7.649, de 25 de janeiro de 1988, que "estabelece a obrigatoriedade do cadastramento dos doadores de sangue bem como a realização de exames laboratoriais no sangue coletado, visando a prevenir a propagação de doença".
O PRESIDENTE DA REPÚBLICA, no uso das atribuições que lhe confere o artigo 81, item III, da Constituição,
DECRETA:
Os órgãos, entidades e profissionais médicos habilitados na forma da lei, que executem atividades hemoterápicas, no território nacional, estão sujeitos, obrigatoriamente, à licença concedida pelo órgão de vigilância sanitária competente das Secretarias de Saúde dos Estados, do Distrito Federal e dos Territórios.
As licenças ficarão condicionadas à satisfação, dentre outras, das seguintes exigências, conforme o tipo de serviço, organização ou estabelecimento:
I - apresentação dos atos constitutivos e comprobatórios da representação legal, no caso de órgãos e entidades;
II - comprovação da habilitação legal dos responsáveis técnicos pelo órgão ou entidade ou do médico que exerça a atividade hemoterápica;
III - disponibilidade de pessoal qualificado, em número suficiente, para o desempenho das diversas tarefas a que se proponha;
IV - apresentação de condições ambientais e de infra‑estrutura operacional satisfatórias;
V - capacitação para realizar exames e análises de laboratório necessários;
VI - atribuição da direção técnica a um médico com o título de especialização em hemoterapia, hematologia, ou que tenha realizado estágio correspondente, devidamente comprovado;
VII - existência de técnico responsável pelo recebimento e conservação do material destinado à coleta e à manipulação do sangue;
VIII - existência de locais, equipamentos e materiais reservados à coleta de sangue e à garantia do tratamento asséptico do...
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