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

Detalhes bibliográficos
Autor(a) principal: Gonçalves Machado, Deusa Helena
Data de Publicação: 2016
Outros Autores: Martins Machado, José Lúcio, Achar, Eduardo, Dias, Cristiane Bitencourt
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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spelling 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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