Panorama de la seguridad del paciente en los laboratorios clínicos de México

Clinical laboratories are a vital component of health services because they approach to patients throughout the entire care process. However, the real impact of laboratory errors on patient safety is unknown, because there is little research and records about errors that occur in the total analysis process of laboratories in Mexico. Compliance with the essential actions for patient safety stated by Mexican government, leads us to analyze the degree to which we can cover the patient’s safety requirements with the Official Mexican Regulations, to detect opportunities for improvement and ensure the safety of patients using laboratory diagnostic services. In this review, a compilation of the most frequent types of laboratory errors in the literature, proposals to address them and some strategies to promote the culture of patient safety in clinical laboratories in Mexico are presented.Los laboratorios clínicos son un componente vital de los servicios de salud, pues abordan a los pacientes durante todo el proceso de atención. No obstante, el impacto real de los errores del laboratorio en la seguridad del paciente es desconocido, debido a que existe escasa investigación y registros sobre los errores que suceden en el proceso total de análisis de los laboratorios en México. El cumplimiento de la NOM-007-SSA3-2011 permite garantizar el cumplimiento de las Acciones esenciales para la seguridad del paciente, aunque es necesario implementar actividades adicionales para prevenir errores y coadyuvar en el proceso de medicación segura. En esta revisión se muestra un panorama sobre la situación de la seguridad del paciente en los laboratorios clínicos de México y se proponen estrategias para abordar los errores de laboratorio y fomentar la cultura de seguridad del paciente

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

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 careEl 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 post examen 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 paciente

Tecnovigilancia en los laboratorios clínicos:: una herramienta para la seguridad del paciente

Health care includes the use of medical devices during its processes, which must comply with the quality and performance characteristics established in the official regulations of each country. Technovigilance is a tool that allows assurance of patient safety by facilitating the notification of adverse events associated with the use of medical devices. Clinical laboratories as users of medical devices are not exempt from technovigilance, so they must align the requirements of this with their particular operational and quality management requirements. This review discusses the importance of technovigilance and analyzes the regulatory framework for its implementation in clinical laboratories of Mexico.La atención sanitaria integra el uso de dispositivos médicos durante sus procesos, los cuales deben cumplir con las características de calidad y desempeño establecidas en la normatividad oficial de cada país. La tecno vigilancia es una herramienta que permite garantizar la seguridad de los pacientes al facilitar la notificación de eventos adversos asociados al uso de dispositivos médicos. Los laboratorios clínicos, como usuarios de dispositivos médicos, no están exentos de la tecno vigilancia, por lo que deben alinear los requisitos de ésta con los requerimientos particulares de funcionamiento y de gestión de la calidad. En esta revisión se discute la importancia de la tecno vigilancia y se analiza el marco regulatorio para la instauración de la misma en los laboratorios clínicos de México

Metallo-beta-lactamase-producing Escherichia coli in the sewage of Mexico City: where do they come from?

While monitoring the presence of antibiotic resistance in municipal wastewater bacteria from Mexico City, five Escherichia coli isolates were detected to be resistant to carbapenems, antibiotics of “last resort” used mostly in hospitals. Further analysis revealed that these carbapenem-resistant isolates carried the gene for a metallo-beta-lactamase, NDM-5. The gene was found to be beared by a large, ~145 kb conjugative plasmid, which also carries putative genes encoding resistance to sulfonamides, trimethoprim, tetracycline, ciprofloxacin, chloramphenicol (although no phenotypic chloramphenicol resistance was detected) and quaternary-ammonium compounds. The plasmid also carried gene mobility determinants, such as an integron integrase, and two transposases. In addition to the direct public health threat posed by the presence of such multi-resistant organisms in wastewater released into the environment and used for crop irrigation; it is particularly concerning that carbapenem-resistant E. coli is rather rare in Mexican hospitals (The accepted manuscript in pdf format is listed with the files at the bottom of this page. The presentation of the authors' names and (or) special characters in the title of the manuscript may differ slightly between what is listed on this page and what is listed in the pdf file of the accepted manuscript; that in the pdf file of the accepted manuscript is what was submitted by the author