Experience report on health regulatory actions in clinical laboratories in Palmas-TO
Autor(a) principal: | |
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Data de Publicação: | 2017 |
Tipo de documento: | Artigo |
Idioma: | por eng |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/815 |
Resumo: | Introduction: The importance and necessity of sanitary surveillance in clinical laboratories and of mechanisms of quality control and promotion throughout the laboratory cycle are well known. Objectives: Due to the importance of clinical laboratories in Palmas, the Municipal Sanitary Surveillance created in 2010 a proposal to improve the regulatory activity in these establishments. Method: The work was developed in four stages in parallel to the Annual Sanitary Licensing. In 2010, the first phase was the re-registration of the establishments and the presentation of the technical dossier in these establishments. In 2011, this was complemented with the analysis, revision, correction and approval of legal and technical documents. In 2012, manuals, pest control plans, waste management, input control and the presence of internal and external quality control were reviewed, as well as the flow for notification of compulsory diseases already in place. In 2013, the presentation and implementation of quality management actions were required and in 2014 the monitoring of the application of these tools was intensified. Results: The results obtained were the acceptance of the regulatory processes, as well as the accomplishment of corrections and inclusion of norms and written procedures in the technical actions and management of the clinical analysis processes. It can be verified that by the requirement of training of technicians, already at the end of 2014, the culture of the training was observed and the need for improvements and corrections of the most probable points of sanitary and analytical problems was verified, mainly having the Sanitary Surveillance as support and partner. Conclusions: It is possible to conclude that the strategy used by the Sanitary Surveillance, associated to Sanitary Licensing and to actions of gradual improvements in search of better management of sanitary risks, culminated in a harmonious relation of advising, in which the action of sanitary surveillance required minimal restrictive measures and several actions of guiding and problem solving in partnership. |
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Experience report on health regulatory actions in clinical laboratories in Palmas-TORelato de experiência sobre as ações de regulação sanitária nos laboratórios clínicos em Palmas-TOLaboratórios ClínicosVigilância SanitáriaRisco SanitárioClinical LaboratoriesSanitary SurveillanceSanitary RiskIntroduction: The importance and necessity of sanitary surveillance in clinical laboratories and of mechanisms of quality control and promotion throughout the laboratory cycle are well known. Objectives: Due to the importance of clinical laboratories in Palmas, the Municipal Sanitary Surveillance created in 2010 a proposal to improve the regulatory activity in these establishments. Method: The work was developed in four stages in parallel to the Annual Sanitary Licensing. In 2010, the first phase was the re-registration of the establishments and the presentation of the technical dossier in these establishments. In 2011, this was complemented with the analysis, revision, correction and approval of legal and technical documents. In 2012, manuals, pest control plans, waste management, input control and the presence of internal and external quality control were reviewed, as well as the flow for notification of compulsory diseases already in place. In 2013, the presentation and implementation of quality management actions were required and in 2014 the monitoring of the application of these tools was intensified. Results: The results obtained were the acceptance of the regulatory processes, as well as the accomplishment of corrections and inclusion of norms and written procedures in the technical actions and management of the clinical analysis processes. It can be verified that by the requirement of training of technicians, already at the end of 2014, the culture of the training was observed and the need for improvements and corrections of the most probable points of sanitary and analytical problems was verified, mainly having the Sanitary Surveillance as support and partner. Conclusions: It is possible to conclude that the strategy used by the Sanitary Surveillance, associated to Sanitary Licensing and to actions of gradual improvements in search of better management of sanitary risks, culminated in a harmonious relation of advising, in which the action of sanitary surveillance required minimal restrictive measures and several actions of guiding and problem solving in partnership.Introdução: São notórias a importância e a necessidade de garantias da normalidade sanitária nos estabelecimentos e de mecanismos de controle e promoção da qualidade em todo o ciclo laboratorial. Objetivo: Pela importância das análises clínicas em Palmas, a Vigilância Sanitária Municipal iniciou em 2010 uma proposta de aprimoramento da atividade regulatória nestes estabelecimentos. Método: O trabalho foi desenvolvido em quatro etapas em paralelo ao Licenciamento Sanitário Anual. Em 2010 foi realizada a primeira fase de recadastramento dos estabelecimentos e a apresentação do dossiê técnico existente nos estabelecimentos. Em 2011, ele se estendeu com a análise, revisão, correção e aprovação dos documentos legais e técnicos. Já em 2012 foram reavaliados os manuais, os planos de controle de pragas, de gerenciamento de resíduos, de controle dos insumos e da presença de controle da qualidade interno e externo além do fluxo para notificação de doenças compulsórias já em aplicação nos estabelecimento. Em 2013 foram exigidas a apresentação e a implementação das ações de gerenciamento da qualidade e, em 2014, intensificou-se o monitoramento da aplicação destas ferramentas. Resultados: Os resultados obtidos foram a aceitação dos processos regulatórios, bem como a realização de correções e a inclusão de normas e procedimentos escritos nas ações técnicas e de gerenciamento dos processos de análises clínicas. Pode-se constatar que, pela exigência da capacitação dos técnicos, já ao final de 2014, observava-se a cultura da capacitação e divulgação da necessidade de aprimoramentos e correções dos pontos de maior probabilidade de problemas sanitários e analíticos, e principalmente tendo a Vigilância Sanitária como um setor de apoio e parceria. Conclusões: Pode-se concluir com esse trabalho que a estratégia utilizada pela Vigilância Sanitária, associada em paralelo com o Licenciamento Sanitário, de ações de melhorias gradativas em busca de melhor gerenciamento dos riscos sanitários culminou em uma relação harmoniosa de assessoramento, na qual a atuação de controle e regulação sanitário necessitou de mínimas medidas impositivas e restritivas e várias ações de orientações e resolução de problemas em parceria.Instituto Nacional de Controle de Qualidade em Saúde2017-08-31info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/81510.22239/2317-269X.00815Health Surveillance under Debate: Society, Science & Technology ; Vol. 5 No. 3 (2017): August; 123-129Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 5 Núm. 3 (2017): Agosto; 123-129Vigil Sanit Debate, Rio de Janeiro; v. 5 n. 3 (2017): Agosto; 123-1292317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (Fiocruz)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/815/392https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/815/538Copyright (c) 2017 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/openAccessTrevisan, Márcio2021-09-30T19:24:59Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/815Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2021-09-30T19:24:59Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (Fiocruz)false |
dc.title.none.fl_str_mv |
Experience report on health regulatory actions in clinical laboratories in Palmas-TO Relato de experiência sobre as ações de regulação sanitária nos laboratórios clínicos em Palmas-TO |
title |
Experience report on health regulatory actions in clinical laboratories in Palmas-TO |
spellingShingle |
Experience report on health regulatory actions in clinical laboratories in Palmas-TO Trevisan, Márcio Laboratórios Clínicos Vigilância Sanitária Risco Sanitário Clinical Laboratories Sanitary Surveillance Sanitary Risk |
title_short |
Experience report on health regulatory actions in clinical laboratories in Palmas-TO |
title_full |
Experience report on health regulatory actions in clinical laboratories in Palmas-TO |
title_fullStr |
Experience report on health regulatory actions in clinical laboratories in Palmas-TO |
title_full_unstemmed |
Experience report on health regulatory actions in clinical laboratories in Palmas-TO |
title_sort |
Experience report on health regulatory actions in clinical laboratories in Palmas-TO |
author |
Trevisan, Márcio |
author_facet |
Trevisan, Márcio |
author_role |
author |
dc.contributor.author.fl_str_mv |
Trevisan, Márcio |
dc.subject.por.fl_str_mv |
Laboratórios Clínicos Vigilância Sanitária Risco Sanitário Clinical Laboratories Sanitary Surveillance Sanitary Risk |
topic |
Laboratórios Clínicos Vigilância Sanitária Risco Sanitário Clinical Laboratories Sanitary Surveillance Sanitary Risk |
description |
Introduction: The importance and necessity of sanitary surveillance in clinical laboratories and of mechanisms of quality control and promotion throughout the laboratory cycle are well known. Objectives: Due to the importance of clinical laboratories in Palmas, the Municipal Sanitary Surveillance created in 2010 a proposal to improve the regulatory activity in these establishments. Method: The work was developed in four stages in parallel to the Annual Sanitary Licensing. In 2010, the first phase was the re-registration of the establishments and the presentation of the technical dossier in these establishments. In 2011, this was complemented with the analysis, revision, correction and approval of legal and technical documents. In 2012, manuals, pest control plans, waste management, input control and the presence of internal and external quality control were reviewed, as well as the flow for notification of compulsory diseases already in place. In 2013, the presentation and implementation of quality management actions were required and in 2014 the monitoring of the application of these tools was intensified. Results: The results obtained were the acceptance of the regulatory processes, as well as the accomplishment of corrections and inclusion of norms and written procedures in the technical actions and management of the clinical analysis processes. It can be verified that by the requirement of training of technicians, already at the end of 2014, the culture of the training was observed and the need for improvements and corrections of the most probable points of sanitary and analytical problems was verified, mainly having the Sanitary Surveillance as support and partner. Conclusions: It is possible to conclude that the strategy used by the Sanitary Surveillance, associated to Sanitary Licensing and to actions of gradual improvements in search of better management of sanitary risks, culminated in a harmonious relation of advising, in which the action of sanitary surveillance required minimal restrictive measures and several actions of guiding and problem solving in partnership. |
publishDate |
2017 |
dc.date.none.fl_str_mv |
2017-08-31 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/815 10.22239/2317-269X.00815 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/815 |
identifier_str_mv |
10.22239/2317-269X.00815 |
dc.language.iso.fl_str_mv |
por eng |
language |
por eng |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/815/392 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/815/538 |
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 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. 5 No. 3 (2017): August; 123-129 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 5 Núm. 3 (2017): Agosto; 123-129 Vigil Sanit Debate, Rio de Janeiro; v. 5 n. 3 (2017): Agosto; 123-129 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 |
_version_ |
1797042047385862144 |