Sanitary Surveillance Actions in clinical laboratories as to Compliance with Resolution nº 302/2015 of the Collegiate Board of Directors of the Brazilian National Health Surveillance Agency
Autor(a) principal: | |
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Data de Publicação: | 2016 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/680 |
Resumo: | Introduction: This study focused on the effectiveness of municipal Sanitary Surveillance actions carried out in the context of clinical laboratories under the jurisdiction of the Regional Health Superintendence of Patos de Minas, state of Minas Gerais, Brazil. Objective: To verify if the Sanitary Surveillance followed eleven regulations set forth by Resolution No. 302/2015 of the Collegiate Board of Directors of the Brazilian Health Surveillance Agency when issuing sanitary permits to such laboratories. Methods: Data were collected from 181 annual health inspection reports from 2006 to 2013. Simple frequency and cross-checking analyses were carried out to treat data. Results: Sanitary Surveillance actions were still incipient in years 2006 and 2007. From 2008 on, however, there has been a significant increase in such actions, although they have shown to be less effective when it comes to compliance with items that are closely related to accuracy of laboratory tests and to the safety of patients and staff. Conclusion: the lack of effectiveness concerning Sanitary Surveillance actions is serious and brings out problems experienced by its team. Such problems ought to be investigated and resolved in order to improve the quality of the services provided by clinical laboratories. |
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Sanitary Surveillance Actions in clinical laboratories as to Compliance with Resolution nº 302/2015 of the Collegiate Board of Directors of the Brazilian National Health Surveillance AgencyAções de Vigilância Sanitária em laboratórios clínicos em relação ao cumprimento da RDC nº 302/2005/Anvisa no âmbito da SRS/Patos de MinasHealth SurveillanceClinical LaboratoryHealth LegislationVigilância SanitáriaLegislação SanitáriaLaboratório ClínicoIntroduction: This study focused on the effectiveness of municipal Sanitary Surveillance actions carried out in the context of clinical laboratories under the jurisdiction of the Regional Health Superintendence of Patos de Minas, state of Minas Gerais, Brazil. Objective: To verify if the Sanitary Surveillance followed eleven regulations set forth by Resolution No. 302/2015 of the Collegiate Board of Directors of the Brazilian Health Surveillance Agency when issuing sanitary permits to such laboratories. Methods: Data were collected from 181 annual health inspection reports from 2006 to 2013. Simple frequency and cross-checking analyses were carried out to treat data. Results: Sanitary Surveillance actions were still incipient in years 2006 and 2007. From 2008 on, however, there has been a significant increase in such actions, although they have shown to be less effective when it comes to compliance with items that are closely related to accuracy of laboratory tests and to the safety of patients and staff. Conclusion: the lack of effectiveness concerning Sanitary Surveillance actions is serious and brings out problems experienced by its team. Such problems ought to be investigated and resolved in order to improve the quality of the services provided by clinical laboratories.Introdução: Este estudo trata da efetividade das ações de Vigilância Sanitária (VISA) municipal em relação ao cumprimento da Resolução da Diretoria Colegiada (RDC) nº 302/2005 no contexto de laboratórios clínicos (LC) jurisdicionados à Superintendência Regional de Saúde de Patos de Minas, Minas Gerais (SRS/PM/MG). Objetivos: Buscou-se verificar se a VISA, ao liberar o alvará sanitário, tem cumprido as exigências de onze itens da referida RDC. Método: Os dados foram obtidos de 181 relatórios anuais de inspeção sanitária realizados de 2006 a 2013. A análise se deu por meio de frequências simples e por cruzamento de dados. Resultados: As ações de VISA mostraram-se incipientes nos anos de 2006 e 2007. A partir do ano de 2008, constatou-se um aumento significativo dessas ações, que foram menos efetivas em relação ao cumprimento de itens que estão sobremaneira ligados à acurácia dos exames laboratoriais e à segurança dos funcionários e dos pacientes. Conclusão: Essa falta de efetividade das ações de VISA pode ser considerada grave e revela problemas vivenciados pela equipe de VISA que devem ser investigados a fim de que essa situação seja solucionada oferecendo, assim, mais qualidade na prestação de serviços dos LC à população.Instituto Nacional de Controle de Qualidade em Saúde2016-08-30info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/68010.22239/2317-269X.00680Health Surveillance under Debate: Society, Science & Technology ; Vol. 4 No. 3 (2016): August; 42-50Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 4 Núm. 3 (2016): Agosto; 42-50Vigil Sanit Debate, Rio de Janeiro; v. 4 n. 3 (2016): Agosto; 42-502317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/680/334Copyright (c) 2016 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessGonçalves Machado, Deusa HelenaMartins Machado, José LúcioAchar, EduardoDias, Cristiane Bitencourt2023-06-27T15:17:11Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/680Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:17:11Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Sanitary Surveillance Actions in clinical laboratories as to Compliance with Resolution nº 302/2015 of the Collegiate Board of Directors of the Brazilian National Health Surveillance Agency Ações de Vigilância Sanitária em laboratórios clínicos em relação ao cumprimento da RDC nº 302/2005/Anvisa no âmbito da SRS/Patos de Minas |
title |
Sanitary Surveillance Actions in clinical laboratories as to Compliance with Resolution nº 302/2015 of the Collegiate Board of Directors of the Brazilian National Health Surveillance Agency |
spellingShingle |
Sanitary Surveillance Actions in clinical laboratories as to Compliance with Resolution nº 302/2015 of the Collegiate Board of Directors of the Brazilian National Health Surveillance Agency Gonçalves Machado, Deusa Helena Health Surveillance Clinical Laboratory Health Legislation Vigilância Sanitária Legislação Sanitária Laboratório Clínico |
title_short |
Sanitary Surveillance Actions in clinical laboratories as to Compliance with Resolution nº 302/2015 of the Collegiate Board of Directors of the Brazilian National Health Surveillance Agency |
title_full |
Sanitary Surveillance Actions in clinical laboratories as to Compliance with Resolution nº 302/2015 of the Collegiate Board of Directors of the Brazilian National Health Surveillance Agency |
title_fullStr |
Sanitary Surveillance Actions in clinical laboratories as to Compliance with Resolution nº 302/2015 of the Collegiate Board of Directors of the Brazilian National Health Surveillance Agency |
title_full_unstemmed |
Sanitary Surveillance Actions in clinical laboratories as to Compliance with Resolution nº 302/2015 of the Collegiate Board of Directors of the Brazilian National Health Surveillance Agency |
title_sort |
Sanitary Surveillance Actions in clinical laboratories as to Compliance with Resolution nº 302/2015 of the Collegiate Board of Directors of the Brazilian National Health Surveillance Agency |
author |
Gonçalves Machado, Deusa Helena |
author_facet |
Gonçalves Machado, Deusa Helena Martins Machado, José Lúcio Achar, Eduardo Dias, Cristiane Bitencourt |
author_role |
author |
author2 |
Martins Machado, José Lúcio Achar, Eduardo Dias, Cristiane Bitencourt |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Gonçalves Machado, Deusa Helena Martins Machado, José Lúcio Achar, Eduardo Dias, Cristiane Bitencourt |
dc.subject.por.fl_str_mv |
Health Surveillance Clinical Laboratory Health Legislation Vigilância Sanitária Legislação Sanitária Laboratório Clínico |
topic |
Health Surveillance Clinical Laboratory Health Legislation Vigilância Sanitária Legislação Sanitária Laboratório Clínico |
description |
Introduction: This study focused on the effectiveness of municipal Sanitary Surveillance actions carried out in the context of clinical laboratories under the jurisdiction of the Regional Health Superintendence of Patos de Minas, state of Minas Gerais, Brazil. Objective: To verify if the Sanitary Surveillance followed eleven regulations set forth by Resolution No. 302/2015 of the Collegiate Board of Directors of the Brazilian Health Surveillance Agency when issuing sanitary permits to such laboratories. Methods: Data were collected from 181 annual health inspection reports from 2006 to 2013. Simple frequency and cross-checking analyses were carried out to treat data. Results: Sanitary Surveillance actions were still incipient in years 2006 and 2007. From 2008 on, however, there has been a significant increase in such actions, although they have shown to be less effective when it comes to compliance with items that are closely related to accuracy of laboratory tests and to the safety of patients and staff. Conclusion: the lack of effectiveness concerning Sanitary Surveillance actions is serious and brings out problems experienced by its team. Such problems ought to be investigated and resolved in order to improve the quality of the services provided by clinical laboratories. |
publishDate |
2016 |
dc.date.none.fl_str_mv |
2016-08-30 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Peer-reviewed article" "Artículo revisado por pares" "Artigo avaliado pelos pares" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/680 10.22239/2317-269X.00680 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/680 |
identifier_str_mv |
10.22239/2317-269X.00680 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/680/334 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by-nc-nd/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc-nd/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
dc.source.none.fl_str_mv |
Health Surveillance under Debate: Society, Science & Technology ; Vol. 4 No. 3 (2016): August; 42-50 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 4 Núm. 3 (2016): Agosto; 42-50 Vigil Sanit Debate, Rio de Janeiro; v. 4 n. 3 (2016): Agosto; 42-50 2317-269X reponame:Vigilância Sanitária em Debate instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Vigilância Sanitária em Debate |
collection |
Vigilância Sanitária em Debate |
repository.name.fl_str_mv |
Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br |
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1797042044648030208 |