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...
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Sociedade Brasileira de Patologia Clínica
2020-07-01
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| Series: | Jornal Brasileiro de Patologia e Medicina Laboratorial |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442020000100422&tlng=pt |
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| author | Mylner O. F. Souza Keren H. S. Souza Juvanete A. Távora Érika R. G. Costa Rafael L. Resque Madson R. F. Gomes Deyse S. Dantas |
| author_facet | Mylner O. F. Souza Keren H. S. Souza Juvanete A. Távora Érika R. G. Costa Rafael L. Resque Madson R. F. Gomes Deyse S. Dantas |
| author_sort | Mylner O. F. Souza |
| collection | DOAJ |
| description | 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 Macapá, Amapá, 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. |
| first_indexed | 2024-12-20T16:59:31Z |
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| id | doaj.art-391dc13dc7e14f71a307fda8f150cb29 |
| institution | Directory Open Access Journal |
| issn | 1678-4774 |
| language | English |
| last_indexed | 2024-12-20T16:59:31Z |
| publishDate | 2020-07-01 |
| publisher | Sociedade Brasileira de Patologia Clínica |
| record_format | Article |
| series | Jornal Brasileiro de Patologia e Medicina Laboratorial |
| spelling | doaj.art-391dc13dc7e14f71a307fda8f150cb292022-12-21T19:32:35ZengSociedade Brasileira de Patologia ClínicaJornal Brasileiro de Patologia e Medicina Laboratorial1678-47742020-07-015610.5935/1676-2444.20200039Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/AnvisaMylner O. F. Souzahttps://orcid.org/0000-0001-6434-496XKeren H. S. SouzaJuvanete A. TávoraÉrika R. G. CostaRafael L. ResqueMadson R. F. GomesDeyse S. DantasABSTRACT 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 Macapá, Amapá, 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.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442020000100422&tlng=ptclinical analysis laboratoryevaluation studies as a subjectlegislation as a subject |
| spellingShingle | Mylner O. F. Souza Keren H. S. Souza Juvanete A. Távora Érika R. G. Costa Rafael L. Resque Madson R. F. Gomes Deyse S. Dantas Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/Anvisa Jornal Brasileiro de Patologia e Medicina Laboratorial clinical analysis laboratory evaluation studies as a subject legislation as a subject |
| title | Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/Anvisa |
| title_full | Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/Anvisa |
| title_fullStr | Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/Anvisa |
| title_full_unstemmed | Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/Anvisa |
| title_short | Nonconformities in clinical laboratories in Macapá, Amapá, Brazil, based on the RDC no. 302/2005/Anvisa |
| title_sort | nonconformities in clinical laboratories in macapa amapa brazil based on the rdc no 302 2005 anvisa |
| topic | clinical analysis laboratory evaluation studies as a subject legislation as a subject |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442020000100422&tlng=pt |
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