Calidad del informe de resultados de la detección molecular de SARS-CoV-2: necesidad de estandarización.

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Bibliographic Details
Title:	Calidad del informe de resultados de la detección molecular de SARS-CoV-2: necesidad de estandarización.
Alternate Title:	Quality of the SARS-CoV-2 molecular detection report: the need for standardization.
Authors:	Mucito-Varela, Eduardo¹ eduardomucito@gmail.com
Source:	Revista CONAMED. ene-mar2021, Vol. 26 Issue 1, p3-16. 14p.
Abstract (English):	The laboratory report is a communication mechanism between the clinical laboratory and the physicians, so its content must comply with international quality criteria. In the context of the COVID-19 pandemic, the molecular diagnosis carried out in 163 laboratories in Mexico has increased the diagnostic capacity and epidemiological monitoring. Despite having national and international guidelines for the interpretation of this test, the content of the report has not been standardized, increasing the risk of errors that affect patient safety. This study proposes a list of standardized requirements based on the ISO 1589:2012 standard, which was used to evaluate the content of 13 laboratory reports. Some requirements should be improved and others implemented, in order to guarantee the appropriate use of the molecular detection of the SARS-CoV-2 virus, the correct interpretation and the quality assurance of the post-examination phase of the clinical laboratories. A more detailed consensus is needed where participation of societies of clinical laboratory professionals and physicians is needed to generate a report that adds value to patient care. [ABSTRACT FROM AUTHOR]
Abstract (Spanish):	El informe de resultados es un mecanismo de comunicación entre el laboratorio clínico y los médicos, por lo que su contenido debe ajustarse a los criterios de calidad internacionales. En el contexto de la pandemia por COVID-19, el diagnóstico molecular realizado en 163 laboratorios de México ha incrementado la capacidad diagnóstica y monitoreo epidemiológico. A pesar de contar con guías nacionales e internacionales para la interpretación de este examen, no se ha estandarizado el contenido del informe, lo que aumenta el riesgo de errores que afectan la seguridad del paciente. En este estudio se propone una lista de requisitos estandarizados basados en la Norma ISO 1589:2012, con la cual se evaluó el contenido de 13 informes de laboratorio. Se detectaron requisitos que deben ser mejorados y otros implementados, con el objetivo de garantizar el uso apropiado de la prueba de detección molecular del virus SARS-CoV-2, así como la correcta interpretación y el aseguramiento de la calidad postexamen de los laboratorios clínicos. Es necesario realizar un consenso más detallado en el que participen sociedades de profesionales del laboratorio clínico y médicos para generar un informe que agregue valor a la atención de los pacientes. [ABSTRACT FROM AUTHOR]
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Database:	MedicLatina

Description
Abstract:	The laboratory report is a communication mechanism between the clinical laboratory and the physicians, so its content must comply with international quality criteria. In the context of the COVID-19 pandemic, the molecular diagnosis carried out in 163 laboratories in Mexico has increased the diagnostic capacity and epidemiological monitoring. Despite having national and international guidelines for the interpretation of this test, the content of the report has not been standardized, increasing the risk of errors that affect patient safety. This study proposes a list of standardized requirements based on the ISO 1589:2012 standard, which was used to evaluate the content of 13 laboratory reports. Some requirements should be improved and others implemented, in order to guarantee the appropriate use of the molecular detection of the SARS-CoV-2 virus, the correct interpretation and the quality assurance of the post-examination phase of the clinical laboratories. A more detailed consensus is needed where participation of societies of clinical laboratory professionals and physicians is needed to generate a report that adds value to patient care. [ABSTRACT FROM AUTHOR]
ISSN:	14056704
DOI:	10.35366/99123