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.

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)

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.

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)

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)

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.

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.

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.

External quality control program in infectious diseases screening at laboratories and blood banks in Latin America: an analysis of the past 5 years / Programa de control externo de la calidad en el tamizaje de enfermedades infecciosas en laboratorios y bancos de sangre de América Latina: análisis de los últimos 5 años / Programa externo de controle de qualidade na triagem de doenças infecciosas em laboratórios e bancos de sangue da América Latina: análise dos últimos 5 anos

ABSTRACT Objective. To evaluate the screening of blood samples for infectious disease markers at laboratories and blood banks in Latin America per the findings of an External Quality Assessment Program (EQAP). Methods. This qualitative analysis used data from the EQAP coordinated by the Fundação Pro Sangue Hemocentro de São Paulo with the support of the Pan American Health Organization to assess the performance of blood screening for infectious diseases from 2014 to 2018 in Latin America. Each participating laboratory or blood bank received an identical blind panel with 24 blood samples with variable reactivity for all the screening parameters. Panels were processed at each participating facility and results were returned to the Fundação Pro Sangue Hemocentro de São Paulo for individual and joint analyses. Two types of discrepant results were potential failures: false positive results (FPRs) and false nonreactive results (FNRRs). Results. A total of 23 136 samples were evaluated. Global rates of FPR, FNRR, and concordant results were 0.3%, 1.0% and 98.7%, respectively. Seven FNRRs were found for HBsAg (1.0%), 12 for syphilis (2.6%), and 21 for Chagas disease (2.9%). No FNRRs were found for the HIV, HCV, and HTLV viruses. The average accuracy of all the laboratories and blood banks participating in the EQAP during the study period was 99.5% (standard deviation, 0.5%). Conclusion. The findings of this qualitative analysis are positive for blood safety in Latin America, with an average accuracy of 99.5% among the participating laboratories and blood banks. This report reflects an important improvement in blood bank serological screening EQAP-PAHO report since the 2003.

RESUMEN Objetivo. Evaluar el tamizaje de muestras de sangre en las que se analizan marcadores de enfermedades infecciosas en laboratorios y bancos de sangre de América Latina según los resultados de un programa de evaluación externa de la calidad (EQAP, por su sigla en inglés). Métodos. Este análisis cualitativo utilizó datos del EQAP —coordinado por la Fundação Pro Sangue Hemocentro de São Paulo con el apoyo de la Organización Panamericana de la Salud— para evaluar la eficacia del tamizaje sanguíneo para la detección de enfermedades infecciosas que se realizó entre el 2014 y el 2018 en América Latina. Cada laboratorio o banco de sangre participante recibió un panel idéntico para análisis a ciegas compuesto por 24 muestras de sangre con reactividad variable para todos los parámetros del tamizaje. Los paneles se procesaron en cada establecimiento participante y los resultados se enviaron a la Fundação Pro Sangue Hemocentro de São Paulo donde se realizaron análisis individuales y conjuntos. Había dos tipos de resultados discrepantes que eran posibles fallas del tamizaje: los positivos falsos (PF) y los negativos falsos (NF). Resultados. En total se evaluaron 23 136 muestras. Las tasas generales de PF, NF y resultados concordantes fueron, respectivamente, del 0,3%, 1,0% y 98,7%. Se obtuvieron siete NF en casos de HBsAg (1,0%), 12 en casos de sífilis (2,6%) y 21 en casos de enfermedad de Chagas (2,9%). No se obtuvieron NF en casos de infección por virus del VIH, el VHC o el VLTH. La precisión promedio de todos los laboratorios y bancos de sangre participantes en el EQAP durante el periodo de estudio fue del 99,5% (desviación típica: 0,5%). Conclusión. Los resultados de este análisis cualitativo son positivos en lo referente a la seguridad sanguínea en América Latina, con una precisión promedio del 99,5% entre los laboratorios y bancos de sangre participantes. Este informe refleja la considerable mejora del tamizaje serológico que se realiza en los bancos de sangre, en comparación con los resultados del informe del EQAP que contó con el apoyo de la OPS y se publicó en el 2003.

RESUMO Objetivo. Avaliar a triagem de marcadores de doenças infecciosas em amostras de sangue realizada em laboratórios e bancos de sangue da América Latina de acordo com os resultados de um Programa Externo de Avaliação de Qualidade (EQAP, na sigla em inglês). Métodos. Esta análise qualitativa usou dados do EQAP coordenado pela Fundação Pró-Sangue Hemocentro de São Paulo, com o apoio da Organização Pan-Americana da Saúde, para avaliar o desempenho da triagem de sangue quanto a doenças infecciosas no período de 2014 a 2018 na América Latina. Cada laboratório ou banco de sangue participante recebeu um painel cego idêntico com 24 amostras de sangue de reatividade variável para todos os parâmetros de triagem. Os painéis foram processados em cada estabelecimento participante e os resultados foram devolvidos à Fundação Pró-Sangue Hemocentro de São Paulo para análises individuais e conjuntas. Dois tipos de resultados discrepantes representavam falhas em potencial: resultados falso-positivos e resultados falso-negativos (não reativos). Resultados. Foram avaliadas 23.136 amostras. As taxas globais de resultados falso-positivos, falso-negativos e concordantes foram de 0,3%, 1,0% e 98,7%, respectivamente. Foram encontrados sete resultados falso-negativos para HBsAg (1,0%), 12 para sífilis (2,6%) e 21 para doença de Chagas (2,9%). Não houve resultados falso-negativos para os vírus HIV, HCV e HTLV. A acurácia média de todos os laboratórios e bancos de sangue que participaram do EQAP durante o período do estudo foi de 99,5% (desvio padrão de 0,5%). Conclusões. Os resultados desta análise qualitativa são positivos para a segurança do sangue na América Latina, com uma acurácia média de 99,5% entre os laboratórios e bancos de sangue participantes. Este relatório reflete uma melhoria importante na triagem sorológica dos bancos de sangue em relação aos resultados do relatório do EQAP apoiado pela OPAS que foi publicado em 2003.

Teores de polifenóis totais e de umidade em amostras de rizomas de Limonium brasiliense / Total polyphenols and moisture contents in samples of Limonium brasiliense rhizomes / Polifenoles totales y contenido de humedad en muestras de rizomas de Limonium brasiliense

O Limonium brasiliense (Boiss.) Kuntze (Plumbaginaceae), chamado popularmente de baicuru ou guaicuru é uma erva perene presente em todo litoral sul do Brasil, sendo indicada tradicionalmente para síndrome pré-menstrual e distúrbios menstruais. Essas atividades são atribuídas à presença dos polifenóis concentrados em seus rizomas, que também apresentam atividades bacteriostáticas, antioxidantes, antivirais e anti-inflamatórias. No desenvolvimento de formulações feitas a partir da droga vegetal são necessários testes de controle de qualidade durante todo o processo a fim de garantir a segurança, eficácia e qualidade da matéria-prima até sua formulação final. As metodologias utilizadas no desenvolvimento deste trabalho foram de análises físico-químicas para o controle de qualidade, análises quantitativas para determinação do teor de polifenóis totais e, por fim, uma análise comparativa entre os resultados obtidos no ano da coleta do material vegetal (2010) e das mesmas características após 13 anos da coleta, utilizando amostras do L. brasiliense com a presença de fungos ou sem nos rizomas. Sendo assim, este trabalho teve como objetivo realizar o controle de qualidade comparativo dos rizomas de Limonium brasiliense coletados em 2010 em relação ao teor de polifenóis totais e de umidade em 2023. Os resultados obtidos evidenciaram a produção de polifenóis pelos fungos na amostra contaminada, além de mostrarem a qualidade de armazenagem da droga vegetal. Com isso, foi possível concluir que o teor de polifenóis totais da amostra com fungo aumentou após 13 anos da coleta, e que neste interim não houve mudanças no teor de umidade da amostra sem fungo, garantindo sua qualidade no desenvolvimento de formulações ou pesquisas futuras.

Limonium brasiliense (Boiss.) Kuntze (Plumbaginaceae), popularly called baicuru or guaicuru, is a perennial herb present throughout the southern coast of Brazil, traditionally indicated for premenstrual syndrome and menstrual disorders. These activities are attributed to the presence of polyphenols concentrated in its rhizomes, which also have bacteriostatic, antioxidant, antiviral and anti-inflammatory activities. When developing formulations made from plant-based drugs, quality control tests are necessary throughout the process to ensure the safety, efficacy and quality of the raw material until its final formulation. The methodologies used in the development of this work were physical-chemical analyzes for quality control, quantitative analyzes to determine the total polyphenol content and, finally, a comparative analysis between the results obtained in the year the plant material was collected (2010) and the same characteristics after 13 years of collection, using samples of L. brasiliense with or without the presence of fungi in the rhizomes. Therefore, this work aimed to carry out comparative quality control of Limonium brasiliense rhizomes collected in 2010 in relation to the content of total polyphenols and moisture in 2023. The results obtained showed the production of polyphenols by fungi in the contaminated sample, in addition to show the storage quality of the plant drug. With this, it was possible to conclude that the total polyphenol content of the sample with fungus increased after 13 years of collection, and that in the meantime there were no changes in the moisture content of the sample without fungus, guaranteeing its quality in the development of formulations or future research.

Limonium brasiliense (Boiss.) Kuntze (Plumbaginaceae), popularmente llamada baicuru o guaicuru, es una hierba perenne presente en toda la costa sur de Brasil, tradicionalmente indicada para el síndrome premenstrual y trastornos menstruales. Estas actividades se atribuyen a la presencia de polifenoles concentrados en sus rizomas, que también tienen actividades bacteriostáticas, antioxidantes, antivirales y antiinflamatorias. Cuando se desarrollan formulaciones elaboradas a partir de medicamentos de origen vegetal, son necesarios ensayos de control de calidad durante todo el proceso para garantizar la seguridad, eficacia y calidad de la materia prima hasta su formulación final. Las metodologías utilizadas en el desarrollo de este trabajo fueron análisis físico- químicos para control de calidad, análisis cuantitativos para determinar el contenido de polifenoles totales y, finalmente, un análisis comparativo entre los resultados obtenidos en el año de recolección del material vegetal (2010) y el mismas características después de 13 años de colecta, utilizando muestras de L. brasiliense con o sin presencia de hongos en los rizomas. Por lo tanto, este trabajo tuvo como objetivo realizar un control de calidad comparativo de los rizomas de Limonium brasiliense recolectados en 2010 en relación al contenido de polifenoles totales y humedad en 2023. Los resultados obtenidos mostraron la producción de polifenoles por hongos en la muestra contaminada, además de mostrar la calidad de almacenamiento de la droga vegetal. Con esto se pudo concluir que el contenido total de polifenoles de la muestra con hongos aumentó después de 13 años de colecta, y que mientras tanto no hubo cambios en el contenido de humedad de la muestra sin hongos, garantizando su calidad en el desarrollo. de formulaciones o investigaciones futuras.

Evaluación de riesgo biológico en el control de calidad de vacunas virales / Biological risk evaluation in the quality control of viral vaccines

Las medidas de bioseguridad son el conjunto de conductas mínimas a ser adoptadas, a fin de reducir o eliminar los riesgos para el personal, la comunidad y el medio ambiente. Los laboratorios veterinarios manipulan materiales biológicos que pueden suponer riesgos biológicos tanto para los animales como para el hombre, por lo que los profesionales de estos laboratorios están expuestos a una variedad de riesgos relacionados con su trabajo que pueden afectar su salud. El objetivo de este trabajo fue evaluar el riesgo en el control de calidad de las vacunas virales mediante el uso del método BIOGAVAL, una forma cómoda y fiable de evaluar el riesgo de exposición a agentes biológicos. El estudio se realizó en la Unidad Empresarial de Base Control de la Calidad de la Empresa Productora de Vacunas Virales y Bacterianas el cual pertenece a LABIOFAM. La muestra de estudio estuvo conformada por 18 trabajadores, distribuidos en tres áreas. En los resultados obtenidos para valores superiores a 12 del nivel de acción biológica se requiere la adopción de medidas preventivas para reducir la exposición en el caso de Avulavirus, Pestivirus y Coronavirus, mientras que para Alphavirus se requieren acciones correctoras inmediatas ya que representa una situación de riesgo intolerable(AU)

Biosafety measures are the set of minimum behaviors to be adopted, in order to reduce or eliminate risks to personnel, the community and the environment. Veterinary laboratories handle biological materials that can pose biological risks for both animals and humans, so that professionals in these laboratories are exposed to a variety of risks to their health related to their work. The objective of this work was to evaluate the risk in the quality control of viral vaccines through the use of BIOGAVAL method, a convenient and reliable way to assess the risk of exposure to biological agents. The study was carried out in the Base Business Unit Quality Control of the Production Company of Viral and Bacterial Vaccines which belongs to LABIOFAM. The study sample consisted was 18 workers, dispersed in three areas. For values above 12 of the biological action level, preventive measures are required to reduce exposure to Avulavirus, Pestivirus and Coronavirus, while for Alphavirus immediate corrective measures actions are required as it represents an intolerable risk situation(AU)

Uso y optimización de una metodología para la priorización de la validación de métodos analíticos basada en la evaluación de riesgos en Servicios de Farmacia Hospitalaria / Implementation and optimisation of a tool for the prioritisation of analytical method validation based in risk management in Hospital Pharmacies

Objetivo: Poner en práctica y optimizar una metodología para evaluar los riesgos implicados en la elaboración de medicamentos en Servicios de Farmacia Hospitalaria con el fin de priorizar la validación de métodos analíticos de control de calidad. Método: Se han diseñado dos métodos para el cálculo del Número de Prioridad de Riesgo. Para el análisis y comparación entre ambos, se seleccionaron 3 parámetros a evaluar en cada medicamento: vía de administración, frecuencia de dispensación y complejidad del proceso de elaboración. A cada uno se asignó 4 niveles de gravedad, siendo 1 el más bajo y 4 el más alto. Se modificaron los criterios para la asignación de la gravedad en cada parámetro evaluado en el Método 2 con respecto al Método 1. Ambos métodos se han ensayado sobre 65 fórmulas. Resultados: El Método 1 segrega las formulaciones en 8 grupos según su Número de Prioridad de Riesgo. El Método 2 las separa en 14 grupos de 16 posibles. La frecuencia, en el Método 1 agrupa el 92,31% de las fórmulas en el primer nivel; la complejidad acumula el 86,15% en los niveles 2 y 4. Mientras el Método 2 separa el 25% de fórmulas en cada nivel según frecuencia, al segregar por cuartiles. La complejidad, al diferenciar las fórmulas asépticas con esterilización final de las elaboradas mediante llenado aséptico, separa las formulaciones en grupos más homogéneos. Conclusiones: El Método 2 es capaz de priorizar de forma más eficaz la validación de los métodos analíticos de las fórmulas analizadas, mejorando la consecución del objetivo propuesto. (AU)

Aim: To implement an optimise a methodology to evaluate the risks involved in the compounding of drug products in Hospital Pharmacy Services with the objective of prioritise the validation of analytical methods for quality control. Method: Two different methods were designed to assess the Risk Priority Number. For their analysis and comparison, 3 parameters were evaluated in each drug product: administration route, dispensing rate and compounding process complexity. To each parameter 4 levels of severity were allotted, being 1 the lowest and 4 the highest. The criteria to assign the level of severity for each parameter differ in both methods used. 65 drug products were evaluated with each method. Results: The use of Método 1 segregates drug products in 8 groups as per the Risk Priority Number, whilst Método 2 separates them in 14 groups out of the 16 feasible ones. Dispensing rate in Método 1 lumps together in the first level 92,31% of the drug products; complexity, by its side, clusters 86,15% in levels 2 and 4. On the other hand, Método 2 divides drug products in groups of 25% per severity level according to dispensing rate, since they are distributed in quartiles. Complexity, since it separates aseptic drug products exposed to final sterilisation from the ones compounded by aseptic processing, sets products apart in a more homogeneous groups. Conclusions: Método 2 is capable to prioritise in a more effective way the validation of analytical methods for quality control of analysed drug products; with a slightly higher convolution, it accomplishes the aim of these methods to a larger extent. (AU)