Control de Calidad de las Plantas Medicinales de la Farmacia Natural del CAMEC

Objectives. To evaluate the quality of twenty medicinal plants that are dispensed in the Natural Pharmacy of the CAMEC of the Hospital III Chimbote - Red Asistencial Ancash - EsSalud. Materials and methods. Analytical-descriptive research. Twenty medicinal plants were analyzed: Berberis vulgaris, Bixa orellana, Chuquiraga rotundifolia, Culcitium canescens, Desmodium mollicum, Equisetum arvense, Eupatorium triplinerve, Gentianella alborosea, Geranium ayavacense, Maytenus laevis, Melissa officinalis, Minthostachys setosa, Muehlenbeckia volcanica, Peumus boldus, Phyllanthus niruri, Senecio tephrosioides, Smallanthus sonchifolius, Tiquilia paranychioides, Uncaria tomentosa, Valeriana officinalis. The samples were selected at random (1 bag of 100 g) to which organoleptic analyses such as smell, taste, color, surface characteristics, and texture were carried out, as well as the physical-chemical analysis (phytochemical test). Likewise, it was carried out the aqueous extraction of each plant (infuse or decoct), according to the dose indicated to the patients. Mayer, Wagner, Dragendorff, Fehling, ferric trichloride, Shinoda, and foam tests were also carried out. Finally, total ashes, moisture content, and the determination of heavy metals (lead and cadmium) were analyzed by the atomic absorption spectrometry method. Results. Each of the twenty plants analyzed has the organoleptic characteristics of its species. In the qualitative phytochemical analysis, the highest presence of phenols was found. In the total ashes, two plants were found to exceed the limits allowed by the WHO (14%), Eupatorium triplinerve "asmachilca" with 22.027%, and Berberis vulgaris "agracejo" with 15.2843%. In humidity, the values obtained are within the limits allowed by the WHO (12%). In heavy metals, none of the samples showed concentrations higher than the limit value: lead (10 mg/kg), cadmium (0.3 mg/kg), proposed for medicinal herbs by the WHO. Conclusions. The medicinal plants dispensed in the Natural Pharmacy of CAMEC Chimbote comply with the quality parameters established by the WHO.

Objetivos. Evaluar la calidad de veinte plantas medicinales que se dispensan en la Farmacia Natural del CAMEC del Hospital III Chimbote - Red Asistencial Ancash - EsSalud. Materiales y métodos. Investigación analítica-descriptiva. Se analizaron veinte plantas medicinales: Berberis vulgaris, Bixa orellana, Chuquiraga rotundifolia, Culcitium canescens, Desmodium mollicum, Equisetum arvense, Eupatorium triplinerve, Gentianella alborosea, Geranium ayavacense, Maytenus laevis, Melissa officinalis, Minthostachys setosa, Muehlenbeckia volcanica, Peumus boldus, Phyllanthus niruri, Senecio tephrosioides, Smallanthus sonchifolius, Tiquilia paranychioides, Uncaria tomentosa, Valeriana officinalis. Las muestras fueron seleccionadas al azar (1 bolsa de 100 g) a las cuales se les realizaron los análisis organolépticos como olor, sabor, color, características superficiales y textura, así como el análisis físico-químico (ensayo fitoquímico). Asimismo, se realizó la extracción acuosa de cada planta (infuso o decocto), según la dosis indicada a los pacientes. También se llevaron a cabo las pruebas de Mayer, Wagner, Dragendorff, Fehling, tricloruro férrico, Shinoda y espuma. Finalmente se analizaron las cenizas totales, el contenido de humedad y la determinación de metales pesados (plomo y cadmio) por el método de espectrometría de absorción atómica. Resultados. Cada una de las veinte plantas analizadas tiene las características organolépticas propias de su especie. En el análisis fitoquímico cualitativo se encontró la mayor presencia de fenoles. En las cenizas totales se encontraron dos plantas que sobrepasan los límites permitidos por la OMS (14%), Eupatorium triplinerve «asmachilca¼ con 22,027 % y Berberis vulgaris «agracejo¼ con 15,2843 %. En humedad, los valores obtenidos están dentro de los límites permitidos por la OMS (12%). En metales pesados, ninguna de las muestras evidenció concentraciones superiores al valor límite: plomo (10 mg/kg), cadmio (0,3 mg/kg), propuesto para hierbas medicinales por la OMS. Conclusiones. Las plantas medicinales que se dispensan en la Farmacia Natural del CAMEC Chimbote cumplen con los parámetros de calidad establecidos por la OMS.

Metas. Avaliar a qualidade de vinte plantas medicinais que são dispensadas na Farmácia Natural CAMEC do Hospital III Chimbote - Red Asistencial Ancash - EsSalud. Materiais e métodos. Pesquisa analítico-descritiva. Foram analisadas vinte plantas medicinais: Berberis vulgaris, Bixa orellana, Chuquiraga rotundifolia, Culcitium canescens, Desmodium mollicum, Equisetum arvense, Eupatorium triplinerve, Gentianella alborosea, Geranium ayavacense, Maytenus laevis, Melissa officinalis, Minthostachys setosa, Muehlenbeckia volcanica, Peumus boldus, Phyllanthus niruri , Senecio tephrosioides, Smallanthus sonchifolius, Tiquilia paranychioides, Uncaria tomentosa, Valeriana officinalis. As amostras foram selecionadas aleatoriamente (1 saco de 100 g) às quais foram realizadas análises organolépticas como odor, sabor, cor, características de superfície e textura, além de análises físico-químicas (teste fitoquímico). Da mesma forma, foi realizada a extração aquosa de cada planta (infusão ou decocção), de acordo com a dose indicada aos pacientes. Também foram realizados testes de Mayer, Wagner, Dragendorff, Fehling, tricloreto férrico, Shinoda e espuma. Por fim, as cinzas totais, o teor de umidade e a determinação de metais pesados ​​(chumbo e cádmio) foram analisados ​​pelo método de espectrometria de absorção atômica. Resultados. Cada uma das vinte plantas analisadas possui as características organolépticas de sua espécie. Na análise fitoquímica qualitativa foi encontrada maior presença de fenóis. Nas cinzas totais foram encontradas duas plantas que ultrapassam os limites permitidos pela OMS (14%), Eupatorium triplinerve "asmachilca" com 22,027% e Berberis vulgaris "barberry" com 15,2843 %. Na umidade, os valores obtidos estão dentro dos limites permitidos pela OMS (12%). Nos metais pesados, nenhuma das amostras apresentou concentrações superiores ao valor limite: chumbo (10 mg/kg), cádmio (0,3 mg/kg), proposto para ervas medicinais pela OMS. Conclusões. As plantas medicinais dispensadas na Farmácia Natural CAMEC Chimbote cumprem os parâmetros de qualidade estabelecidos pela OMS.

Development and validation of an alternative procedure for quantitative quality control analysis of 99mTc-radiopharmaceuticals using a Geiger Müller counter.

BACKGROUND AND OBJECTIVES: In a hospital radiopharmacy with 2a operational level, including the preparation of radiopharmaceuticals from prepared and approved reagent kits, it is common to have a single activimeter or dose calibrator for labeling and fractionation, and to perform the quality controls of the 99mTc-radiopharmaceuticals. In certain cases, the accumulation of radioactive material or accidental contamination of the work area causes the background to exceed the limits to carry out the radiochemical purity analyses and it is necessary to look for viable alternatives. In this work, a Geiger Müller detector (equipped with a probe for measuring surface contamination) frequently used for radioprotection purposes, was validated as an alternative and its performance was compared against the activimeter for 99mTc-radiopharmaceuticals. MATERIALS AND METHODS: Using [99mTc]pertechnetate, systematic studies of error analyses and detector response to activity concentration, activity and measurement time were carried out in liquid matrices and in paper. The results were compared against an activimeter calibrated for [99mTc]Tc. RESULTS: The developed method was used to determine the radiochemical purity of the compounds [99mTc]Tc-MDP and [99mTc]Tc-MIBI by ascending paper chromatography tests, obtaining comparable values to those measured with an activimeter in the same system (within 1% uncertainty) and using the method of vial partitioning in a dedicated equipment. CONCLUSIONS: This work demonstrates that a Geiger Müller detector with a probe for measuring surface contamination can be adequately used to replace other equipment in the control of radiochemical purity in the hospital radiopharmacy.

Assessing and Achieving Quality in Qualitative Research: Clues for Researchers in Training* / Valorar y lograr la calidad de la investigación cualitativa: claves para investigadores en formación / Avaliar e alcançar a qualidade da pesquisa qualitativa: chaves para pesquisadores em formação

This article deals with the particularities of the quality of qualitative research, under the double lens of valuing it and ensuring it. While achieving the quality of qualitative research concerns only those who have opted for this methodology, assessing it is everyone's business because researchers in training will encounter, in the literature reviews, qualitative studies on which they must reflect and estimate their quality. Appreciating the quality of a research work is a complex activity as it is situated within a context and conducted by individuals who use any of the means available to do so. The means they use are criteria as evaluation guides and criteria checklists. For researchers in training, I suggest some guiding criteria to evaluate qualitative publications and ensure quality during the research process, key issues that they must address.

Este artículo trata sobre las particularidades de la calidad de la investigación cualitativa, bajo la doble lente de valorarla y asegurarla. Mientras que alcanzar la calidad de una investigación cualitativa atañe solo a los que han optado por esta metodología, valorarla es asunto de todos, ya que los investigadores en formación se encontrarán en las revisiones bibliográficas con estudios cualitativos sobre los cuales deberán reflexionar y estimar su calidad. Apreciar la calidad de un trabajo de investigación es una actividad compleja ya que está situada en un contexto y llevada a cabo por personas que usan alguno de los medios disponibles para hacerlo. Los medios que usan son los criterios como guías de evaluación y los listados de verificación de criterios. Para los investigadores en formación sugiero unos criterios guía para la valoración de publicaciones cualitativas y para asegurar la calidad durante el proceso de investigación, unas cuestiones claves a las que deben atender.

Este artigo trata das particularidades da qualidade da pesquisa qualitativa, sob a dupla lente de valorizá-la e garanti-la. Embora alcançar a qualidade da pesquisa qualitativa seja do interesse de quem optou por esta metodologia, Avaliar é tarefa de todos, pois os pesquisadores em formação se encontrarão em revisões bibliográficas com estudos qualitativos, sobre os quais deverão refletir e estimar sua qualidade. Avaliar a qualidade de um trabalho de investigação é uma atividade complexa, pois está situada num context e é realizada por pessoas que utilizam qualquer um dos meios disponíveis para o fazer. Os meios que utilizam são critérios como guias de avaliação e listas de verificação de critérios. Aos pesquisadores em formação, sugiro alguns critérios norteadores para avaliar publicações qualitativas e para garantir a qualidade durante o processo de pesquisa, questões chaves que devem ser abordadas.

Detection and reduction of errors in parenteral nutrition compounding through gravimetric and product control. / [Artículo traducido] Detección y reducción de errores en la elaboración de la nutrición parenteral mediante control gravimétrico y de producto.

OBJECTIVE: To analyze the errors in the preparation of parenteral nutrition in a Pharmacy Service, detected through an already consolidated gravimetric and product quality control, and compare them with those detected during the initial years of implementing this quality control. METHODS: All errors detected through quality control in the compounding of pediatric and adult parenteral nutrition between 2019 and 2021 were prospectively analyzed. This quality control consisted of 3 sequential processes: a visual check, a gravimetric control, and a product control. Errors were classified as gravimetric, when the nutrition had a deviation of more than 5% from the theoretical weight, or as product errors when a qualitative or quantitative error was detected upon reviewing the remainder of the components used. These errors were analyzed in terms of type and the component involved. A comparison was made with the errors detected during the implementation phase of this quality control from 2016 to 2018. RESULTS: A total of 41,809 parenteral nutritions were reviewed, and 345 errors were detected (0.83% of the preparations); of these, 59 errors were found in pediatric nutritions (0.68% of them), and 286 in adult nutritions (0.86% of them). Among these errors, 193 were of gravimetric nature, while 152 were detected through product control. The main components involved in product errors were electrolytes, primarily due to the addition of excessive volumes and the use of incorrect components. A significant absolute reduction of 0.71% (p < 0.05) in the total number of errors was observed when compared to the implementation phase. This reduction was consistent in both gravimetric errors (-0.59%) and product-related errors (-0.12%) (p < 0.05). CONCLUSIONS: Comprehensive quality control of parenteral nutrition preparation is an easily implementable tool that effectively detected and prevented significant errors. Furthermore, its widespread adoption contributed to a reduction in the overall error count.

Controles de calidad externos en el diagnóstico molecular de enfermedades genéticas. Impacto sobre la calidad de los estudios genéticos / External quality controls in the molecular diagnosis of genetic diseases. Impact on the quality of the genetic studies / Controles de qualidade externos no diagnóstico molecular de doenças genéticas. Impacto na qualidade dos estudos genéticos

Resumen La participación en programas de evaluación externa de la calidad (PEEC) dirigidos al diagnóstico de enfermedades genéticas permite obtener una medida objetiva del desempeño técnico y analítico de los laboratorios y es un requisito para la acreditación de los laboratorios clínicos bajo la norma ISO 15189. El objetivo de este estudio fue evaluar retrospectivamente el desempeño en los esquemas EMQN (European Molecular Genetics Quality Network) y CF Network (Cystic Fibrosis European Network) en el período 2014-2022. Se participó en un total de 88 esquemas. Se recolectó la información de nuestros puntajes y las medias de los laboratorios participantes en las categorías genotipificación, interpretación y exactitud de la información del paciente/informe. Se informó en forma completa el 90,9% (n=80) de los esquemas. El desempeño en genotipificación mostró puntajes superiores a la media en el 89,3% de los esquemas; 0,8% de los informes correspondieron a falsos negativos. En interpretación, el 66,7% de los esquemas evidenció un desempeño superior a la media y el 33,3% debajo de la media. La exactitud de la información del paciente/informe presentó puntajes superiores a la media en el 97,6% de los esquemas. Se observó una diferencia estadísticamente significativa en el porcentaje de esquemas con puntaje por encima de la media en el año 2022 (10/12 esquemas) respecto al año 2014 (1/6 esquemas) en la categoría interpretación (p=0,0128). En conclusión, la participación regular en PEEC tuvo impacto positivo en la calidad de los estudios y permite realizar mejoras continuas a partir de las recomendaciones sugeridas por estos programas.

Abstract Participation in external quality assessment programmes focused on rare genetic diseases makes it possible to assess the laboratory technical and analytical performance and it is a prerequisite for accreditation according to ISO 15189. The objective of this study was to perform a retrospective evaluation of our performance in the EMQN (European Molecular Genetics Quality Network) and the CF Network (Cystic Fibrosis European Network) programmes in the 2014-2022 period. The laboratory performance on genotyping, interpretation and clerical accuracy and patient identifiers in a total of 88 schemes were assessed. The information of our scores and the mean scores of all participating laboratories in the three categories were collected. A total of 90.9% of the schemes were fully completed. The performance in genotyping showed scores above the mean scores in 89.3% of the schemes; 0.8% of the reports correspond to false negative results. Regarding interpretation category, 66.7% of the schemes presented scores above the mean scores and 33.3% below the mean scores. The clerical accuracy and patient identifiers were above the mean scores in 97.6% of the schemes. A statistically significant difference in the percentage of schemes with a score above the mean for the interpretation category in the year 2022 (10/12 schemes) was observed compared to the year 2014 (1/6 schemes) (p=0.0128). In conclusion, regular participation in external quality assessment programmes had a positive impact on the quality of the studies and allows for continuous improvements based on the recommendations suggested by these programmes.

Resumo A participação em programas de avaliação externa da qualidade (PEECs) voltados para o diagnóstico de doenças genéticas permite obter uma mensuração objetiva do desempenho técnico e analítico dos laboratórios e é requisito para a acreditação dos laboratórios clínicos sob a norma ISO 15189. O objetivo desse estudo foi avaliar retrospectivamente o desempenho nos esquemas EMQN (European Molecular Genetics Quality Network) e CF Network (Cystic Fibrosis European Network) no período 2014-2022. Participou-se em um total de 88 esquemas. Foram coletadas informações de nossos escores e das médias dos laboratórios participantes nas categorias genotipagem, interpretação e precisão da informação do paciente/laudo. 90,9% (n=80) dos esquemas foram informados em sua totalidade. O desempenho na genotipagem apresentou escores acima da média em 89,3% dos esquemas; 0,8% dos laudos corresponderam a falsos negativos. Na interpretação, 66,7% dos esquemas apresentaram desempenho acima da média e 33,3% abaixo da média. A precisão das informações do paciente/laudo apresentou escores acima da média em 97,6% dos esquemas. Observou-se diferença estatisticamente significativa no percentual de esquemas com pontuação acima da média no ano de 2022 (10/12 esquemas) em relação ao ano de 2014 (1/6 esquemas) na categoria interpretação (p=0,0128). Em conclusão, a participação regular em PEECs teve um impacto positivo na qualidade dos estudos e permite fazer melhorias contínuas com base nas recomendações sugeridas por esses programas.

Proyecto DUCMA 2.0. Puesta al día sobre la situación actual de las unidades de Cirugía Mayor Ambulatoria en España / DUCMA 2.0 project: Update on the current situation of the outpatient surgery units in Spain

Introducción: La cirugía mayor ambulatoria (CMA) es un sistema de gestión seguro y eficiente para resolver los problemas quirúrgicos, pero su implantación y desarrollo ha sido variable. El objetivo de este estudio es describir las características, la estructura y el funcionamiento de las unidades de Cirugía Mayor Ambulatoria (UCMA) en España. Métodos: Estudio observacional, transversal, multicéntrico basado en una encuesta electrónica, con recogida de datos entre abril y septiembre de 2022. Resultados: En total, 90 UCMA completaron la encuesta. La media del índice de ambulatorización (IA) global es de 63%. Más de la mitad de las UCMA (52%) son de tipo integrado. La mitad las unidades imparte formación para médicos (51%) y personal de enfermería (55%). Los indicadores de calidad más utilizados son la tasa de suspensiones (87%) y de ingresos no previstos (80%). Conclusiones: Se necesita mayor coordinación entre administraciones para obtener datos fiables. Asimismo, se deben implementar sistemas de gestión de calidad en las unidades y desarrollar herramientas para la formación adecuada de los profesionales implicados.(AU)

Introduction: Ambulatory surgery is a safe and efficient management system to solve surgical problems, but its implementation and development has been variable. The aim of this study is to describe the characteristics, structure and functioning of ambulatory surgery units (ASU) in Spain. Methods: Multicenter, cross-sectional, observational study based on an electronic survey, with data collection between April and September 2022. Results: In total, 90 ASUs completed the survey. The mean overall ambulatory index is 63%. More than half of the ASUs (52%) are integrated units. Around half of the units provide training for physicians (51%) and for nurses (55%). The most frequently used quality indicators are suspension rate (87%) and the rate of unplanned admissions (80%). Conclusions: Greater coordination between administrations is needed to obtain reliable data. It is also necessary to implement quality management systems in the different units, as well as to develop tools for the adequate training of the professionals involved.(AU)

Impacto de retroalimentación integral (debriefing) frente al modelo de enseñanza tradicional en la mejora de la calidad en estudios de ultrasonido obstétrico / Impact of comprehensive feedback (debriefing) vs traditional teaching model on quality improvement in obstetric ultrasound studies

Introducción: El debriefing es una técnica que permite mejorar los resultados en el proceso de aprendizaje a través de un proceso de reflexión y retroalimentación. El objetivo del estudio es comparar la efectividad del debriefing frente al modelo tradicional de enseñanza para mejorar el cumplimiento de calidad en ultrasonido obstétrico. Sujetos y métodos: Se evaluaron los resultados del control de calidad de 45 médicos recién egresados de diplomados de ultrasonido durante tres meses. Los médicos fueron divididos en dos grupos para llevar a cabo la retroalimentación de áreas de oportunidad: el grupo de control sólo recibió educación a través del modelo tradicional y el grupo de intervención recibió retroalimentación con metodología de debriefing. Resultados: Al comparar, ambos métodos mostraron ser efectivos para la mejora global del cumplimiento de calidad (42,9% el tradicional; p = 0,0083; 75% el de debriefing; p = 0,0002). El grupo de debriefing fue significativamente mejor en los rubros de calidad global (el 56,7 frente al 38,1%; p = 0,009 frente a p = 0,0432) y error de medición (el 88,1 frente al 68,7%, con significancia estadística; p = 0,349). Conclusión: Ambas técnicas de retroalimentación tuvieron un impacto positivo para la mejora del cumplimiento de la calidad en estudios de ultrasonido obstétrico, y la técnica de debriefing mostró ventajas significativas sobre el modelo deenseñanza tradicional en la retroalimentación de las áreas de oportunidad detectadas.(AU)

Introduction: Debriefing is a technique to improve learning outcomes through a process of reflection and feedback. The aim of the study is to compare the effectiveness of debriefing vs. the traditional teaching model to improve quality compliance in obstetric ultrasound. Subjects and methods: Forty-five recent graduates of ultrasound diploma courses were evaluated during three months of quality control. The physicians were divided into two groups to carry out feedback on areas of opportunity: the control group only received education through the traditional model and the intervention group, which received feedback with debriefing methodology. Results: When compared, both methods were shown to be effective for the overall improvement of quality compliance (42.9% traditional, p = 0.0083, 75% debriefing, p = 0.0002). The debriefing group was significantly better in the areas of overall quality (56.7% vs. 38.1%, p = 0.0090 vs. p = 0.0432), measurement error (88.1% vs. 68.7%, with statistical significance p = 0.349). Conclusion: Both feedback techniques offered positive results for the improvement of quality compliance in obstetric ultrasound studies, with the debriefing technique showing significant advantages over the traditional teaching model in the feedback of detected areas of opportunity.(AU)

La precisión de las causas de defunción con intervención judicial en Cataluña en el periodo 2015-2020. Efecto de la declaración a través de la aplicación IML-Web / The accuracy of the causes of death with judicial intervention in Catalonia in the period 2015-2020. Effect of declaration through IML-Web application

Fundamentos: a partir del 1 enero de 2020, los institutos de medicina legal y ciencias forenses (imlcf) empezaron a declarar las causas de muerte directamente al instituto nacional de estadística (ine) mediante una aplicación web (iml-web). El objetivo de este trabajo fue evaluar el impacto de la implementación de esta aplicación en la calidad de los datos recogidos. Métodos: se realizó un estudio descriptivo utilizando datos de las defunciones con intervención judicial ocurridas en cataluña. Se comparó la información del período 2015-2018 y de 2019 con la de 2020. Se calcularon los porcentajes, con intervalo de confianza, de las causas de defunción poco específicas, según diferentes clasificaciones, sobre el total de causas por período y división judicial. Resultados: el porcentaje total de causas de defunción poco específicas se redujo, de forma no significativa, 1,6 puntos entre el período 2015-2018 y el año 2020. El mismo indicador entre el año 2019 y 2020 se redujo 13,4 puntos. El porcentaje de defunciones poco específicas de causas externas mostró reducciones estadísticamente significativas entre ambos períodos. En general los indicadores mostraron diferencias territoriales. Conclusiones: la implementación del iml-web en el año 2020 supone, en comparación con 2019, una mejora en la calidad de la información notificada. En cambio, si se compara con el período 2015-2018, los datos muestran una calidad similar. A nivel general se valora que la información proporcionada por el imlcf de cataluña a través del iml-web es precisa, pero todavía tiene margen de mejora.(AU)

Background: on january first, 2020, the institutes of legal medicine and forensic sciences (imlcf) began to inform the causes of death directly to the national statistics institute (ine) through a web application (iml-web). The objective of this study was to evaluate the impact of the implementation of this application on the quality of the data collected.methods: a descriptive study using deaths data with judicial intervention that occurred in catalonia was carried out. The data of the period 2015-2018 and 2019 was compared with 2020. The percentages, with confidence intervals, of the causes of death that were not specific, according to different classifications, were calculated on the total of cases by period and territory.results: the total percentage of non-specific deaths had decreased, not significantly, by 1.6 points between the period 2015-2018 and 2020. The same indicator between 2019 and 2020 had decreased by 13.4 points. The percentage of non-specific deaths from external causes showed significant drops between both periods and 2020. In general, the indicators displayed territorial differences.conclusions: the roll-out of the iml-web implies, compared to 2019, an improvement in the quality of the data. On the other hand, compared to the period 2015-2018, the data show a similar level of quality. Generally, it is assessed that the information provided by imlcf of catalonia through the iml-web is accurate, but still has room for improvement.(AU)

Detection and reduction of errors in parenteral nutrition compounding through gravimetric and product control.

OBJECTIVE: To analyze the errors in the preparation of parenteral nutrition in a Pharmacy Service, detected through an already consolidated gravimetric and product quality control, and compare them with those detected during the initial years of implementing this quality control. METHODS: All errors detected through quality control in the compounding of pediatric and adult parenteral nutritions between 2019 and 2021 were prospectively analyzed. This quality control consisted of 3 sequential processes: a visual check, a gravimetric control, and a product control. Errors were classified as gravimetric, when the nutrition had a deviation of more than 5% from the theoretical weight, or as product errors when a qualitative or quantitative error was detected upon reviewing the remainder of the components used. These errors were analyzed in terms of type and the component involved. A comparison was made with the errors detected during the implementation phase of this quality control from 2016 to 2018. RESULTS: A total of 41,809 parenteral nutritions were reviewed, and 345 errors were detected (0.83% of the preparations); of these, 59 errors were found in pediatric nutritions (0.68% of them), and 286 in adult nutritions (0.86% of them). Among these errors, 193 were of gravimetric nature, while 152 were detected through product control. The main components involved in product errors were electrolytes, primarily due to the addition of excessive volumes and the use of incorrect components. A significant absolute reduction of 0.71% (P < .05) in the total number of errors was observed when compared to the implementation phase. This reduction was consistent in both gravimetric errors (-0.59%) and product-related errors (-0.12%) (P < .05). CONCLUSIONS: Comprehensive quality control of parenteral nutrition preparation is an easily implementable tool that effectively detected and prevented significant errors. Furthermore, its widespread adoption contributed to a reduction in the overall error count.

DUCMA 2.0 project: Update on the current situation of the outpatient surgery units in Spain.

INTRODUCTION: Ambulatory surgery is a safe and efficient management system to solve surgical problems, but its implementation and development has been variable. The aim of this study is to describe the characteristics, structure and functioning of ambulatory surgery units (ASU) in Spain. METHODS: Multicenter, cross-sectional, observational study based on an electronic survey, with data collection between April and September 2022. RESULTS: In total, 90 ASUs completed the survey. The mean overall ambulatory index is 63%. More than half of the ASUs (52%) are integrated units. Around half of the units provide training for physicians (51%) and for nurses (55%). The most frequently used quality indicators are suspension rate (87%) and the rate of unplanned admissions (80%). CONCLUSIONS: Greater coordination between administrations is needed to obtain reliable data. It is also necessary to implement quality management systems in the different units, as well as to develop tools for the adequate training of the professionals involved.

Resumen ejecutivo del documento de consenso para la formación y el desarrollo de la ecografía clínica en Medicina Interna: recomendaciones desde el Grupo de Trabajo de Ecografía Clínica de la Sociedad Española de Medicina Interna (GTECO-SEMI) / Executive summary of the consensus document for the training and development of clinical ultrasound in internal medicine: Recommendations from the Clinical Ultrasound Working Group of the Spanish Society of Internal Medicine (GTECO-SEMI)

Introducción Dada la creciente adopción de la ecografía clínica en medicina, es fundamental estandarizar su aplicación, su formación y su investigación. Objetivos y métodos El propósito de este documento es proporcionar recomendaciones de consenso para responder cuestiones sobre la práctica y el funcionamiento de las unidades de ecografía clínica. Participaron 19 expertos y responsables de unidades avanzadas de ecografía clínica. Se utilizó un método de consenso Delphi modificado. Resultados Se consideraron un total de 137 declaraciones de consenso, basadas en la evidencia y en la opinión experta. Las declaraciones fueron distribuidas en 10 áreas. Un total de 99 recomendaciones alcanzaron consenso. Conclusiones Este consenso define los aspectos más importantes de la ecografía clínica en el ámbito de la Medicina Interna, con el objetivo de homogeneizar y promover este avance asistencial en sus diferentes vertientes. El documento ha sido elaborado por el Grupo de Trabajo de Ecografía Clínica y avalado por la Sociedad Española de Medicina Interna. (AU)

Introduction Given the increasing adoption of clinical ultrasound in medicine, it is essential to standardize its application, training, and research. Objectives and methods The purpose of this document is to provide consensus recommendations to address questions about the practice and operation of clinical ultrasound units. Nineteen experts and leaders from advanced clinical ultrasound units participated. A modified Delphi consensus method was used. Results A total of 137 consensus statements, based on evidence and expert opinion, were considered. The statements were distributed across 10 areas, and 99 recommendations achieved consensus. Conclusions This consensus defines the most important aspects of clinical ultrasound in the field of internal medicine, with the aim of standardizing and promoting this healthcare advancement in its various aspects. The document has been prepared by the Clinical Ultrasound Working Group and endorsed by the Spanish Society of Internal Medicine. (AU)

Resumen ejecutivo del documento de consenso para la formación y el desarrollo de la ecografía clínica en Medicina Interna: recomendaciones desde el Grupo de Trabajo de Ecografía Clínica de la Sociedad Española de Medicina Interna (GTECO-SEMI) / Executive summary of the consensus document for the training and development of clinical ultrasound in internal medicine: Recommendations from the Clinical Ultrasound Working Group of the Spanish Society of Internal Medicine (GTECO-SEMI)

Introducción Dada la creciente adopción de la ecografía clínica en medicina, es fundamental estandarizar su aplicación, su formación y su investigación. Objetivos y métodos El propósito de este documento es proporcionar recomendaciones de consenso para responder cuestiones sobre la práctica y el funcionamiento de las unidades de ecografía clínica. Participaron 19 expertos y responsables de unidades avanzadas de ecografía clínica. Se utilizó un método de consenso Delphi modificado. Resultados Se consideraron un total de 137 declaraciones de consenso, basadas en la evidencia y en la opinión experta. Las declaraciones fueron distribuidas en 10 áreas. Un total de 99 recomendaciones alcanzaron consenso. Conclusiones Este consenso define los aspectos más importantes de la ecografía clínica en el ámbito de la Medicina Interna, con el objetivo de homogeneizar y promover este avance asistencial en sus diferentes vertientes. El documento ha sido elaborado por el Grupo de Trabajo de Ecografía Clínica y avalado por la Sociedad Española de Medicina Interna. (AU)

Introduction Given the increasing adoption of clinical ultrasound in medicine, it is essential to standardize its application, training, and research. Objectives and methods The purpose of this document is to provide consensus recommendations to address questions about the practice and operation of clinical ultrasound units. Nineteen experts and leaders from advanced clinical ultrasound units participated. A modified Delphi consensus method was used. Results A total of 137 consensus statements, based on evidence and expert opinion, were considered. The statements were distributed across 10 areas, and 99 recommendations achieved consensus. Conclusions This consensus defines the most important aspects of clinical ultrasound in the field of internal medicine, with the aim of standardizing and promoting this healthcare advancement in its various aspects. The document has been prepared by the Clinical Ultrasound Working Group and endorsed by the Spanish Society of Internal Medicine. (AU)

Executive summary of the consensus document for the training and development of clinical ultrasound in Internal Medicine: Recommendations from the Clinical Ultrasound Working Group of the Spanish Society of Internal Medicine (GTECO-SEMI).

INTRODUCTION: Given the increasing adoption of clinical ultrasound in medicine, it is essential to standardize its application, training, and research. OBJECTIVES AND METHODS: The purpose of this document is to provide consensus recommendations to address questions about the practice and operation of clinical ultrasound units. Nineteen experts and leaders from advanced clinical ultrasound units participated. A modified Delphi consensus method was used. RESULTS: A total of 137 consensus statements, based on evidence and expert opinion, were considered. The statements were distributed across 10 areas, and 99 recommendations achieved consensus. CONCLUSIONS: This consensus defines the most important aspects of clinical ultrasound in the field of Internal Medicine, with the aim of standardizing and promoting this healthcare advancement in its various aspects. The document has been prepared by the Clinical Ultrasound Working Group and endorsed by the Spanish Society of Internal Medicine.

Aseguramiento y control de la calidad de los datos en un estudio de cohorte en Colombia

Introducción: La calidad de los datos facilita garantizar la fiabilidad de los estudios observacionales. Objetivo: Describir el aseguramiento y el control de calidad para mantener la fiabilidad y la validez del dato en un estudio de cohorte. Métodos: Presentar el manejo de datos implementado dentro de un seguimiento de enfermos renales crónicos cuya exposición fue un programa de protección renal comparado con el tratamiento convencional y su asociación con desenlaces clínicos. Se evaluó el cambio en la frecuencia de errores después de implementar el plan y la reproducibilidad del ingreso de registros a las bases de datos. Resultados: Se documentó una disminución progresiva en los errores cometidos en la captación de datos. El valor de Kappa entre los recolectores de la información para las variables clínicas más importantes fue 0,960 para la depuración de creatinina 150 mg/dL; 0,730 para la alteración del sedimento urinario; 0,956 para la asignación de estadio al ingreso. Los coeficientes de correlación intraclase para la identificación de las cifras de presión arterial sistólica fue 0,996; para la de presión arterial diastólica 0,993 y para los niveles de creatinina sérica al diagnóstico 0,995. Discusión: La calidad de los datos comienza con el reconocimiento de los retos y dificultades que implica su responsable captación, de ahí el aporte de la estandarización de los procesos y el personal que los lleve a cabo en forma idónea. Estudios evidencian que muchos procesos de mejora surgen en el desarrollo de la investigación sin protocolos preestablecidos. Conclusión: La reducción en la proporción y el tipo de error durante el proceso de captación de datos se debe a su identificación temprana y la corrección de instructivos, del instrumento de control de diligenciamiento y de la capacitación continua del personal. El análisis mostró una buena concordancia interevaluador.

Introduction: Data quality makes it easier to ensure that observational studies are reliable. Objective: To describe assurance and quality control to maintain data reliability and validity in a cohort study. Methodology: We present the data management strategies implemented in a study that followed patients of chronic kidney disease who were in a renal protection program and compared them with those undergoing conventional treatment to observe its association with clinical outcomes. We assessed the changes in error frequency after implementing the plan along with the reproducibility of the strategies for entering records into the databases. Results: We documented a progressive decrease of data collection errors. The Kappa values among data collectors for the most important variables were: 0.960 for creatinine clearance 150 mg/dl; 0.730 for urinary sediment alteration and 0.956 for stage allocation upon admission. The intraclass correlation coefficient for the identification of systolic blood pressure was 0.996; for diastolic blood pressure, the coefficient was 0.993 and for serum creatinine levels at diagnosis, the value was 0.995. Discussion: Data quality begins with the recognition of the challenges and difficulties involved in responsible data collection, hence the contribution of standardized processes and personnel to carry them out in a suitable manner. Studies show that many improvement processes arise in the development of research without pre-established protocols. Conclusion: The reduction in error ratio and type during the data collection process are the result of the early identification of erroneously entered or missing data, the correction of the guidelines for completing forms as well as of the instruments for detecting errors and continuous training of the staff. The analysis showed good inter-rater reliability.

Development of blood transfusion external quality assessment program at national scale

Introduction: External quality assessment is a crucial component in ensuring the quality of blood transfusion testing laboratories. Objectives: To develop a procedure for generating external quality assessment items for blood transfusion testing to evaluate participants' performance. Methods: Experimental research was conducted at Quality Control Center for Medical laboratory- University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam. Three items, including red blood cell, serum, and atypical antibody serum samples, were assessed for homogeneity and stability; 5 assessment areas, including ABO grouping, Rh grouping, compatible cross matches, Coombs test, and screening of atypical antibodies, were utilized to evaluate the performance of 38 participants in the 2020-2021 period. Results: Red blood cell and serum samples maintained quality for a specific period at controlled temperatures, while serum samples with atypical antibodies showed stability at different temperatures. The participants demonstrated high satisfactory performance in ABO grouping, Rh grouping, Coombs test, and screening for atypical antibodies. However, the most unsatisfactory performance was reported in crossmatching, with 15% of participants unsatisfactory results. Conclusion: The procedure of production of proficiency testing items has been successfully developed, and its application at the national level is suggested to improve the quality of blood transfusion laboratories.

Introducción: La evaluación externa de calidad es esencial para asegurar la calidad de los laboratorios de pruebas de transfusión sanguínea. Objetivos: Desarrollar un procedimiento para generar elementos de evaluación externa de calidad y evaluar el rendimiento de los participantes en pruebas de transfusión sanguínea. Métodos: Estudio experimental realizado en el Centro de Control de Calidad para Laboratorios Médicos de la Universidad de Medicina y Farmacia en la Ciudad de Ho Chi Minh, Vietnam. Se evaluaron muestras de glóbulos rojos, suero y suero con anticuerpos atípicos para homogeneidad y estabilidad. Se utilizaron 5 áreas de evaluación, incluida la agrupación ABO, la agrupación Rh, las coincidencias cruzadas compatibles, la prueba de Coombs y la detección de anticuerpos atípicos, para evaluar el desempeño de 38 participantes, en el período 2020-2021. Resultados: Las muestras de glóbulos rojos y suero mantuvieron la calidad durante un período específico a temperaturas controladas, mientras que las muestras de suero con anticuerpos atípicos mostraron estabilidad a diferentes temperaturas. Los participantes obtuvieron un alto rendimiento en algunas áreas, como la agrupación ABO y Rh, la prueba de Coombs y la detección de anticuerpos atípicos. Sin embargo, las pruebas de compatibilidad reportaron un rendimiento insatisfactorio en un 15% de los participantes. Conclusión: El procedimiento desarrollado cumple con los criterios de calidad, y se sugiere su aplicación a nivel nacional para mejorar la calidad de los laboratorios de transfusión sanguínea.

Sistema de monitorización del plan de estudio, en función del perfil de egreso, como un mecanismo de contribución a la mejora de la calidad / Study plan monitoring system, based on the graduation profile, as a contribution mechanism to quality improvement

Introducción: El desarrollo universitario y el aumento de la oferta en educación superior han generado la necesidad de incorporar sistemas para monitorizar y asegurar la calidad de las instituciones, las carreras y los programas educativos. Esto ha motivado el interés de generar y fortalecer mecanismos de control de calidad de los procesos formativos. Material y métodos: Se diseñó un mecanismo que utiliza en una primera etapa encuestas que se aplican a docentes y estudiantes para monitorizar el cumplimiento del perfil de egreso de la carrera de Odontología de la Universidad Diego Portales. Posteriormente, en una segunda etapa se realizan grupos focales para enriquecer la información y validar los resultados. Resultados: Los resultados obtenidos avalan que el plan de estudio permite el desarrollo de las competencias declaradas en el perfil de egreso; existe correspondencia interna entre los contenidos, las metodologías, los criterios y los instrumentos de evaluación; se utilizan variadas metodologías educativas; existen criterios de evaluación; y se evalúan la mayoría de los aprendizajes, que se consideran pertinentes. Docentes y estudiantes reconocen parcialmente el nivel de preparación que adquieren después de cursar asignaturas monitorizadas. Conclusiones: Esta monitorización contribuye al diagnóstico de brechas y falencias en el plan de estudio. Permite realizar ajustes de forma oportuna, avalando que estos sistemas son necesarios. La naturaleza del mecanismo de monitorización permite utilizarse por otras carreras.(AU)

Introduction: The academic development and the increase in the offer in higher education, have generated the need to incorporate tools to monitor and to ensure the quality of institutions, careers, and educational programs. Which have motivated the interest in generating quality control mechanisms for these purposes. Materials and methods: it was designed a monitoring tool that uses in a first stage, surveys to teachers and students to monitor the compliance of the graduation profile of the Diego Portales University Dentistry career. Subsequently, in a second stage, focus groups were held to enrich the information and validate the results. Results: The results showed that the study plan allows the development of the competences declared in the graduation profile; correspondence between the contents, methodologies, criteria and evaluation instruments are presents; various educational methodologies are used; evaluation criteria exists and most of the learning is evaluated and considering it as relevant. Teachers and students partially recognize the level of preparation they acquire after completing the monitored subjects. Conclusions: This monitoring contributes to the diagnosis of gaps and shortcomings in the Study Plan. It allows adjustments in a timely manner, and it shows that these monitoring tools are a necessity. The essence of the questionnaire allows it to be used by other careers as well.(AU)

Reporting antimicrobial susceptibilities and phenotypes of resistance to vancomycin in vancomycin-resistant Enterococcus spp. clinical isolates: A nationwide proficiency study / Informe de sensibilidad antimicrobiana y fenotipos de resistencia a vancomicina en aislados clínicos de Enterococcus spp. resistentes a vancomicina: estudio multicéntrico nacional

Introduction: The ability of Spanish microbiology laboratories to (a) determine antimicrobial susceptibility (AS), and (b) correctly detect the vancomycin resistance (VR) phenotype in vancomycin-resistant Enterococcus spp. (VRE) was evaluated. Methods: Three VRE isolates representing the VanA (E. faecium), VanB (E. faecium) and VanC (E. gallinarum) VR phenotypes were sent to 52 laboratories, which were asked for: (a) AS method used; (b) MICs of ampicillin, imipenem, vancomycin, teicoplanin, linezolid, daptomycin, ciprofloxacin, levofloxacin and quinupristin–dalfopristin, and high-level resistance to gentamicin and streptomycin; (c) VR phenotype. Results: (a) The most frequently used system was MicroScan; (b) according to the system, the highest percentage of discrepant MICs was found with gradient strips (21.3%). By antimicrobial, the highest rates of discrepant MICs ranged 16.7% (imipenem) to 0.7% (linezolid). No discrepant MICs were obtained with daptomycin or levofloxacin. Mayor errors (MEs) occurred with linezolid (1.1%/EUCAST) and ciprofloxacin (5.0%/CLSI), and very major errors (VMEs) with vancomycin (27.1%/EUCAST and 33.3%/CLSI) and teicoplanin (5.7%/EUCAST and 2.3%/CLSI). For linezolid, ciprofloxacin, and vancomycin, discrepant MICs were responsible for these errors, while for teicoplanin, errors were due to a misassignment of the clinical category. An unacceptable high percentage of VMEs was obtained using gradient strips (14.8%), especially with vancomycin, teicoplanin and daptomycin; (c) 86.4% of the centers identified VanA and VanB phenotypes correctly, and 95.0% the VanC phenotype. Conclusion: Most Spanish microbiology laboratories can reliably determine AS in VRE, but there is a significant percentage of inadequate interpretations (warning of false susceptibility) for teicoplanin in isolates with the VanB phenotype.(AU)

Introducción: Se evaluó la capacidad de los laboratorios de microbiología españoles para: (a) determinar la sensibilidad antimicrobiana (SA); y (b) detectar correctamente el fenotipo de resistencia a vancomicina (FRV) en Enterococcus spp. resistente a vancomicina (ERV). Métodos: Se enviaron 3 aislados de ERV (E. faecium/VanA, E. faecium/VanB y E. gallinarum/VanC) a 52 laboratorios, a los que se les solicitó: (a) método de SA; (b) CMI de ampicilina, imipenem, vancomicina, teicoplanina, linezolid, daptomicina, ciprofloxacino, levofloxacino y quinupristina-dalfopristina y resistencia de alto nivel a gentamicina y estreptomicina; y (c) fenotipo de resistencia a vancomicina. Resultados: (a) El sistema más utilizado fue MicroScan; y (b) el mayor porcentaje de CMI discrepantes se produjo con las tiras de gradiente (21,3%). Las tasas más elevadas de CMI discrepantes variaron entre el 16,7% (imipenem) y el 0,7% (linezolid). Se produjeron errores mayores con linezolid (1,1%/EUCAST) y ciprofloxacino (5,0%/CLSI) y errores máximos con vancomicina (27,1%/EUCAST y 33,3% CLSI) y teicoplanina (5,7%/EUCAST y 2,3%/CLSI). Para linezolid, ciprofloxacino y vancomicina las CMI discrepantes fueron las responsables de estos errores, mientras que para teicoplanina los errores se debieron a una asignación errónea de la categoría clínica. Se obtuvo un alto porcentaje de errores máximos utilizando tiras de gradiente (14,8%), especialmente con vancomicina, teicoplanina y daptomicina; y (c) el 86,4% de los centros identificaron correctamente los fenotipos VanA y VanB y el 95,0% el fenotipo VanC. Conclusión: La mayoría de los laboratorios de microbiología españoles determinan de forma fiable la SA en ERV, pero existe un porcentaje significativo de interpretaciones inadecuadas (falsa sensibilidad) para teicoplanina en aislados con fenotipo VanB.(AU)

Análisis retrospectivo del diferimiento quirúrgico a un año de la pandemia COVID-19 / Retrospective analysis of the one-year surgical deferral of the COVID-19 pandemic

Resumen: Introducción: El diferimiento quirúrgico desde el inicio de la pandemia COVID-19 representa un riesgo para la salud de los pacientes y un reto para las instituciones sanitarias. La métrica de indicadores de productividad en quirófano, como la tasa de diferimiento quirúrgico, nos brindará información para planear estrategias basadas en evidencia científica que nos permitan mejorar la calidad de la atención. Objetivo: Determinar la tasa de diferimiento quirúrgico durante la pandemia COVID-19. Material y métodos: Se realizó un estudio, retrospectivo, descriptivo y transversal en el que se analizaron 297 pacientes cuyas cirugías fueron diferidas durante el período comprendido del 11 de marzo de 2020 al 10 de marzo de 2021. Para el análisis de variables se efectuó estadística descriptiva, utilizando medidas de tendencia central y dispersión, frecuencias simples y proporciones. Adicionalmente se realizó un diagrama de Pareto. La información fue procesada con SPSS v-25.0. Resultados: La proporción de diferimiento fue de 7.34%; 20.92% de las causas fueron atribuidas al paciente, 31.65% a causas médicas y 47.49% fueron logístico-administrativas. Conclusión: Las causas de diferimiento quirúrgico establecidas son evitables y revelan fracasos en los procesos logístico-administrativos que requieren planes de mejora continua.

Abstract: Introduction: Surgical deferral since the beginning of the COVID-19 pandemic represents a risk to the health of patients and a challenge for health institutions. The metric of productivity indicators in the operating room, such as the surgical deferral rate, will provide us with information to plan strategies based on scientific evidence that allow us to improve the quality of care. Objective: To determine the surgical deferral rate during the COVID-19 pandemic. Material and methods: A retrospective, descriptive and cross-sectional study was carried out in which 297 patients whose surgeries were deferred during the period from March 11, 2020 to March 10, 2021 were analyzed. Descriptive statistics were employed, using measures of central tendency and dispersion, simple frequencies and proportions. Additionally, a Pareto diagram was made. The information was processed with SPSS v-25.0. Results: The deferral rate was 7.34%. 20.92% of the causes were attributed to the patient, 31.65% to medical causes and 47.49% logistic-administrative. Conclusion: The established causes of surgical deferral are avoidable and reveal failures in the logistical-administrative processes that require continuous improvement plans.

Reporting antimicrobial susceptibilities and phenotypes of resistance to vancomycin in vancomycin-resistant Enterococcus spp. clinical isolates: A nationwide proficiency study.

INTRODUCTION: The ability of Spanish microbiology laboratories to (a) determine antimicrobial susceptibility (AS), and (b) correctly detect the vancomycin resistance (VR) phenotype in vancomycin-resistant Enterococcus spp. (VRE) was evaluated. METHODS: Three VRE isolates representing the VanA (E. faecium), VanB (E. faecium) and VanC (E. gallinarum) VR phenotypes were sent to 52 laboratories, which were asked for: (a) AS method used; (b) MICs of ampicillin, imipenem, vancomycin, teicoplanin, linezolid, daptomycin, ciprofloxacin, levofloxacin and quinupristin-dalfopristin, and high-level resistance to gentamicin and streptomycin; (c) VR phenotype. RESULTS: (a) The most frequently used system was MicroScan; (b) according to the system, the highest percentage of discrepant MICs was found with gradient strips (21.3%). By antimicrobial, the highest rates of discrepant MICs ranged 16.7% (imipenem) to 0.7% (linezolid). No discrepant MICs were obtained with daptomycin or levofloxacin. Mayor errors (MEs) occurred with linezolid (1.1%/EUCAST) and ciprofloxacin (5.0%/CLSI), and very major errors (VMEs) with vancomycin (27.1%/EUCAST and 33.3%/CLSI) and teicoplanin (5.7%/EUCAST and 2.3%/CLSI). For linezolid, ciprofloxacin, and vancomycin, discrepant MICs were responsible for these errors, while for teicoplanin, errors were due to a misassignment of the clinical category. An unacceptable high percentage of VMEs was obtained using gradient strips (14.8%), especially with vancomycin, teicoplanin and daptomycin; (c) 86.4% of the centers identified VanA and VanB phenotypes correctly, and 95.0% the VanC phenotype. CONCLUSION: Most Spanish microbiology laboratories can reliably determine AS in VRE, but there is a significant percentage of inadequate interpretations (warning of false susceptibility) for teicoplanin in isolates with the VanB phenotype.