根据RDC no. 1,巴西macapap临床实验室不符合项。302/2005 / Anvisa的

Q4 Medicine
Mylner O. F. Souza, Keren Hapuque da Silva Souza, Juvanete A. Távora, É. Costa, R. Resque, Madson R F Gomes, D. S. Dantas
{"title":"根据RDC no. 1,巴西macapap<e:1>临床实验室不符合项。302/2005 / Anvisa的","authors":"Mylner O. F. Souza, Keren Hapuque da Silva Souza, Juvanete A. Távora, É. Costa, R. Resque, Madson R F Gomes, D. S. Dantas","doi":"10.5935/1676-2444.20200039","DOIUrl":null,"url":null,"abstract":"ABSTRACT Introduction: Clinical analysis laboratories are health care facilities that provide resources for outpatient and/or emergency diagnoses; they are regulated in Brazil by the Resolution of the Collegiate Board of Directors (RDC) no. 302, of October 13, 2005, of the Brazilian National Agency of Sanitary Surveillance (Anvisa). Objective: The aim of this study was to perform a normative evaluation in clinical analysis laboratories, based on RDC no. 302, of October 13, 2005. Material and method: This is a cross-sectional and descriptive study. Twelve clinical laboratories participated in the study. The data were obtained through a structured questionnaire and answered by the technical leaders of the participating laboratories, in the municipality of Macapa, Amapa, Brazil. Results: The average nonconformity found among the participants was 9.64%, which allowed an overall evaluation among them as satisfactory, in relation to the minimum requirements demanded by the standardization recommended by Anvisa. When the participants were analyzed individually, there was a variation from 4.82% to 21.69% of the nonconformities index. Other studies agree with the results, however there is disagreement in a research carried out in Porto Alegre, Rio Grande do Sul, Brazil, possibly due to the fact that the laboratories present in this study do not have a quality management system in their processes. Conclusion: Laboratories 2, 3, 4, 6, 9, 11, and 12 were rated as satisfactory. Laboratories 1, 5, 7, 8 and 10 were rated as partially satisfactory. No laboratories were rated as unsatisfactory.","PeriodicalId":35397,"journal":{"name":"Jornal Brasileiro de Patologia e Medicina Laboratorial","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/Anvisa\",\"authors\":\"Mylner O. F. Souza, Keren Hapuque da Silva Souza, Juvanete A. Távora, É. Costa, R. Resque, Madson R F Gomes, D. S. Dantas\",\"doi\":\"10.5935/1676-2444.20200039\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"ABSTRACT Introduction: Clinical analysis laboratories are health care facilities that provide resources for outpatient and/or emergency diagnoses; they are regulated in Brazil by the Resolution of the Collegiate Board of Directors (RDC) no. 302, of October 13, 2005, of the Brazilian National Agency of Sanitary Surveillance (Anvisa). Objective: The aim of this study was to perform a normative evaluation in clinical analysis laboratories, based on RDC no. 302, of October 13, 2005. Material and method: This is a cross-sectional and descriptive study. Twelve clinical laboratories participated in the study. The data were obtained through a structured questionnaire and answered by the technical leaders of the participating laboratories, in the municipality of Macapa, Amapa, Brazil. Results: The average nonconformity found among the participants was 9.64%, which allowed an overall evaluation among them as satisfactory, in relation to the minimum requirements demanded by the standardization recommended by Anvisa. When the participants were analyzed individually, there was a variation from 4.82% to 21.69% of the nonconformities index. Other studies agree with the results, however there is disagreement in a research carried out in Porto Alegre, Rio Grande do Sul, Brazil, possibly due to the fact that the laboratories present in this study do not have a quality management system in their processes. Conclusion: Laboratories 2, 3, 4, 6, 9, 11, and 12 were rated as satisfactory. Laboratories 1, 5, 7, 8 and 10 were rated as partially satisfactory. No laboratories were rated as unsatisfactory.\",\"PeriodicalId\":35397,\"journal\":{\"name\":\"Jornal Brasileiro de Patologia e Medicina Laboratorial\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Jornal Brasileiro de Patologia e Medicina Laboratorial\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5935/1676-2444.20200039\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Jornal Brasileiro de Patologia e Medicina Laboratorial","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5935/1676-2444.20200039","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0

摘要

摘要简介:临床分析实验室是为门诊和/或急诊诊断提供资源的医疗机构;它们在巴西受到巴西国家卫生监督局(Anvisa)2005年10月13日第302号大学董事会决议的监管。目的:本研究的目的是根据2005年10月13日第302号RDC,在临床分析实验室进行规范性评估。材料和方法:这是一项横断面和描述性研究。12个临床实验室参与了这项研究。数据是通过结构化问卷获得的,由巴西阿马帕州马卡帕市参与实验室的技术负责人回答。结果:参与者中发现的平均不合格率为9.64%,相对于Anvisa推荐的标准化所要求的最低要求,这使得他们的总体评估是令人满意的。当对参与者进行单独分析时,不合格指数的变化范围从4.82%到21.69%。其他研究与结果一致,但在巴西南里奥格兰德州阿雷格里港进行的一项研究中存在分歧,可能是因为本研究中的实验室在其过程中没有质量管理系统。结论:实验室2、3、4、6、9、11和12被评定为合格。实验室1、5、7、8和10被评定为部分令人满意。没有任何实验室被评为不合格。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/Anvisa
ABSTRACT Introduction: Clinical analysis laboratories are health care facilities that provide resources for outpatient and/or emergency diagnoses; they are regulated in Brazil by the Resolution of the Collegiate Board of Directors (RDC) no. 302, of October 13, 2005, of the Brazilian National Agency of Sanitary Surveillance (Anvisa). Objective: The aim of this study was to perform a normative evaluation in clinical analysis laboratories, based on RDC no. 302, of October 13, 2005. Material and method: This is a cross-sectional and descriptive study. Twelve clinical laboratories participated in the study. The data were obtained through a structured questionnaire and answered by the technical leaders of the participating laboratories, in the municipality of Macapa, Amapa, Brazil. Results: The average nonconformity found among the participants was 9.64%, which allowed an overall evaluation among them as satisfactory, in relation to the minimum requirements demanded by the standardization recommended by Anvisa. When the participants were analyzed individually, there was a variation from 4.82% to 21.69% of the nonconformities index. Other studies agree with the results, however there is disagreement in a research carried out in Porto Alegre, Rio Grande do Sul, Brazil, possibly due to the fact that the laboratories present in this study do not have a quality management system in their processes. Conclusion: Laboratories 2, 3, 4, 6, 9, 11, and 12 were rated as satisfactory. Laboratories 1, 5, 7, 8 and 10 were rated as partially satisfactory. No laboratories were rated as unsatisfactory.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Jornal Brasileiro de Patologia e Medicina Laboratorial
Jornal Brasileiro de Patologia e Medicina Laboratorial Health Professions-Medical Laboratory Technology
CiteScore
1.30
自引率
0.00%
发文量
0
审稿时长
20 weeks
期刊介绍: The Jornal Brasileiro de Patologia e Medicina Laboratorial (Brazilian Journal of Pathology and Laboratory Medicine), a continuation of Jornal Brasileiro de Patologia (Brazilian Journal of Pathology), and published quarterly (March, June, September and December) is directed towards the publication of scientific articles that contribute to the development of the area of Laboratory Medicine (Clinical Pathology, Pathology, Cytopathology). It accepts the following categories of articles: original articles, review articles, case reports, short communications, updating articles, letters to editors and reviews.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信