Experience report on health regulatory actions in clinical laboratories in Palmas-TO

Detalhes bibliográficos
Autor(a) principal: Trevisan, Márcio
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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spelling 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
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