Un acercamiento al devenir histórico de la especialidad de Laboratorio Clínico en Villa Clara / An approach to the historical development of the Clinical Lab specialty in Villa Clara

Introducción: el conocimiento de la historia es necesario para dejar constancia del origen y desarrollo de las diferentes especialidades en Villa Clara. Objetivo: exponer una síntesis de elementos históricos sobre la especialidad de Laboratorio Clínico en Villa Clara, posterior al triunfo de la Revolución cubana y la evolución de dicha especialidad. Métodos: se realizó una revisión bibliográfica con análisis crítico-reflexivo sobre el contenido de los documentos. Fueron revisados los archivos de la especialidad, libros y materiales afines al tema tratado, se realizaron entrevistas al personal de laboratorio clínico para indagar sobre años anteriores y hasta la actualidad; se incluyeron las tesis de doctorado, maestrías, artículos originales y de revisión publicados entre 2005 y 2019 en español e inglés. La búsqueda fue realizada en las bases de datos SciELO y Google académico entre enero y marzo de 2020. Desarrollo: se expuso el devenir histórico de la referida especialidad en Villa Clara y los profesionales que participaron, se mostraron aspectos sobre la formación de los recursos humanos, la evolución de la especialidad y los nuevos retos. Conclusiones: se socializaron algunos elementos históricos sobre la especialidad de Laboratorio Clínico en Villa Clara, en la etapa posterior al triunfo de la Revolución cubana como reconocimiento a todos aquellos que contribuyeron al inicio y desarrollo de dicha especialidad que hoy cumple con los estándares de calidad exigidos.

Introduction: knowledge of history is necessary to record the origin and development of the different specialties in Villa Clara. Objective: present a synthesis of historical elements about the specialty of Clinical Laboratory in Villa Clara, after the triumph of the Cuban Revolution and the evolution of said specialty. Methods: a bibliographic review was carried out with reflective critical analysis of the content of the bibliographies. The files of the specialty, books and materials related to the topic discussed were reviewed, interviews were conducted with clinical laboratory personnel to inquire about previous years and up to the present; Doctoral theses, master's degrees, original and review articles published from 2005 to 2019 in Spanish and English were included. The search was carried out in the SciELO and Google academic databases from January to March 2020. Development: the historical development of the specialty in Villa Clara and the professionals who participated were explained, aspects of the training of human resources, the evolution of the specialty and the new challenges were shown. Conclusions: some historical elements were socialized about the specialty of Clinical Laboratory in Villa Clara, in the stage after the triumph of the Cuban Revolution in recognition of all those who contributed to the beginning and development of said specialty that today meets the required quality standards.

Fundamentos teóricos para un sistema de gestión de la calidad en el Laboratorio Provincial de Biología Molecular

El establecimiento de un sistema de gestión de la calidad es obligatorio para algunas instituciones de salud, entre las que se encuentra el Laboratorio de Biología Molecular, esto queda explícito en la Regulación D 03-21, que plantea la obligatoriedad de su cumplimiento para los laboratorios clínicos que se basan en técnicas de biología molecular. El objetivo del presente texto es exponer los presupuestos teóricos que sustentan un estudio sobre la gestión de la calidad en el mencionado laboratorio. Se realiza una revisión documental a partir de artículos publicados en el período comprendido de 2012-2022. Del total de las fuentes consultadas en las plataformas de acceso a bases de datos de la red de información de la salud cubana Infomed: PubMed, Scopus, SciELo, Redalyc, y Dialnet, se seleccionaron 33 para la revisión al considerar que abordaban el tema con mayor profundidad. La adopción de un sistema de gestión de la calidad garantiza y gestiona el alto nivel de los servicios, aumenta la satisfacción del cliente y el prestigio de la organización.

The establishment of a quality management system is mandatory for some health institutions, among which is the Molecular Biology Laboratory. This is explicit in Regulation D 03-21, which makes compliance mandatory for laboratories. clinical trials that are based on molecular biology techniques. The objective of this text is to present the theoretical assumptions that support a study on quality management in the aforementioned laboratory. A documentary review is carried out based on articles published in the period from 2012-2022. Of the total sources consulted on the database access platforms of the cuban health information network Infomed: PubMed, Scopus, SciELo, Redalyc, and Dialnet, 33 were selected for the review considering that they addressed the topic with greater depth. The adoption of a quality management system guarantees and manages the high level of services, increases customer satisfaction and the prestige of the organization.

Sistema de procedimientos para la formación interdisciplinar de la habilidad diagnosticar en residentes de dermatología / A System of Procedures for the Interdisciplinary Training of the Dill To Diagnose in Dermatology Residents

Introducción: En las prácticas de laboratorio se adquiere la habilidad que permite corroborar el diagnóstico de las enfermedades de la piel y anejos después de un diagnóstico presuntivo, con la utilización del método clínico. Esto se respalda en las exigencias establecidas en los documentos normativos de ese proceso formativo. Objetivo: Proponer un sistema de procedimientos para la formación interdisciplinar de la habilidad "diagnosticar enfermedades dermatológicas en los residentes de dermatología, a partir de insuficiencias detectadas en el programa de la especialidad. Métodos: La investigación fue cualitativa, con un estudio descriptivo en el Hospital Provincial General Docente Dr. Antonio Luaces Iraola, de Ciego de Ávila, desde 2018 hasta 2022. Se trabajó con toda la población conformada por 16 residentes de primer año en dermatología. Se utilizaron métodos de nivel teórico, empírico y estadístico. Resultados: En el sistema de procedimientos propuesto, se concretan fortalezas y debilidades, objetivo general, orientaciones metodológicas, precisión de los objetivos específicos y sistema de acciones para cada procedimiento, y sistema de control y evaluación de la efectividad de las acciones realizadas. La demostración de la formación de la habilidad diagnosticar, a través de un caso clínico real, reveló como esencial la consecutividad lógica de las acciones del residente desde la atención médica del caso y la formulación del diagnóstico presuntivo hasta el establecimiento del diagnóstico corroborativo en los laboratorios de anatomía patológica, microbiología y parasitología médica. Conclusiones: Se aporta un sistema de procedimientos que posibilita la formación de la habilidad "diagnosticar enfermedades dermatológicas en los residentes, con carácter secuencial, interdisciplinar e investigativo(AU)

Introduction: Laboratory practices provide the ability that allows corroborating the diagnosis of skin and adnexal diseases after a presumptive diagnosis, with the use of the clinical method. This is supported by the requirements established in the standardization documents of this training process. Objective: To propose a system of procedures for the interdisciplinary training of the skill to diagnose dermatological diseases in Dermatology residents, based on insufficiencies detected in the specialty program. Methods: The research was qualitative and consisted in a descriptive study carried out in Hospital General Docente Dr. Antonio Luaces Iraola, of Ciego de Avila, from 2018 to 2022. The work was done with the entire population made up of 16 first-year residents in Dermatology. Theoretical, empirical and statistical methods were used. Results: In the proposed system of procedures, strengths and weaknesses are specified, together with general objective, methodological guidelines, precision of specific objectives and system of actions for each procedure, as well as system of control and evaluation of the effectiveness of the actions. Demonstrating the received formation for the diagnostic skill, through a real clinical case, revealed as essential the logical consecutivity of the resident's actions from the medical attention of the case and the formulation of the presumptive diagnosis to the establishment of the corroborative diagnosis in the laboratories of pathological anatomy, microbiology and medical parasitology. Conclusions: A system of procedures is provided that makes possible the formation of the skill to diagnose dermatological diseases in residents, with sequential, interdisciplinary and investigative character(AU)

Sistema de información y gestión de resultados para laboratorios - GestLab

Introducción: Los procesos establecidos para el procesamiento, análisis y resultado final de las muestras de PCR, así como el control de los suministros médicos, aún se realizan de forma manual, trayendo consigo la introducción del error humano y un elevado tiempo en la entrega de los resultados. Objetivo: Presentar un sistema que automatiza los procesos de análisis, procesamiento y resultado final de las muestras de PCR, además del control de los suministros médicos en los laboratorios y centros de toma de muestras. Métodos: Con la utilización de las tecnologías para el desarrollo de programas y las herramientas de código abierto, se obtuvo un sistema automatizado para analizar y procesar las muestras de PCR. Resultados: Se implementó un sistema que automatiza el procesamiento, análisis y resultado final de las muestras de PCR, control de los suministros médicos en los laboratorios y centros de toma de muestras. Conclusiones: El sistema automatizado elimina los procesos manuales de análisis, procesamiento y resultado final de las muestras de PCR, control de los suministros médicos en los laboratorios, centros de toma de muestras y logra mayor rapidez en la respuesta a los pacientes.

Introduction: The processes established for the processing, analysis and final result of the PCR samples, as well as the control of the medical supplies to perform these, are still carried out manually, bringing with it the introduction of human error; and a high time in the delivery of the results. Objective: To present a system that automates the processes of analysis, processing and final result of PCR samples, in addition to the control of medical supplies in laboratories and sampling centers. Methods: With the use of technologies for the development of programs and open-source tools, an automated system was obtained to analyze and process the PCR samples. Results: A system was implemented that automates the processing, analysis and final result of PCR samples, control of medical supplies in laboratories and sampling centers. Conclusions: The automated system eliminates the manual processes of analysis, processing and final result of PCR samples, control of medical supplies in laboratories, sample collection centers and achieves faster response to patients.

Status and Prospect of Management Policy and System for High-level Pathogenic Microorganism Laboratories in China / 中山大学学报(医学科学版)

High-level pathogenic microorganism laboratories are strategic scientific and technological forces of national biosafety， so it is significant to improve the policy and system management and strengthen the safety supervision. This paper reviewed the current status of management policy and system of high-level pathogenic microorganism laboratories， summarized the problems and challenges in terms of safety laws and regulations， supervision mechanism， hierarchical and classified management， standards and norms， legal person responsibility system， occupational access system and personnel training system. This paper also proposed targeted policy suggestions that might underlie the biosafety management of high-level pathogenic microorganism laboratories in China.

Management Practice of Outsourcing Hospital Tests to Independent Clinical Laboratories / 中国医疗器械杂志

With the development of medical technology and the deepening of medical reform, hospital laboratory test continues to expand. Affected by factors such as technology and cost, the business of outsourcing laboratory test to independent clinical laboratories develops rapidly. However, this cooperation mode has not been carried out for a long time and lacks systematic management experience. Through the analysis of the motivation of hospital delivery, this study expounds the classification, judgment basis and requirements for suppliers of third-party clinical laboratory delivery, as well as the operation practice of laboratory test delivery, so as to provide reference for more standardized and effective testing delivery for hospitals.

Hematological parameters: is there a difference between those released by the hematological analyzer and to the customer?

ABSTRACT Objective This study aimed to compare the hematological parameters released by hematological analyzers with those released in customer reports. Methods We conducted a descriptive study in the laboratories of a medium-sized municipality in the state of Minas Gerais registered in the National Register of Health Establishments. Interviews were conducted using a questionnaire to obtain information regarding the parameters released by the analyzers and those available in the customer's report. Results Sixteen laboratories were evaluated, and none of them released all the parameters obtained from the hematological analyzers to customers. The red blood cell distribution width was released in 88% of the laboratories, atypical lymphocytes in 70%, mean platelet volume in 50%, platelet distribution width and platelet count in 20%. No laboratory released information on reticulocytes, fraction of immature reticulocytes and immature granulocytes, nucleated erythrocyte count, immature platelet fraction and reticulocyte hemoglobin, and large platelet rate. Conclusion All evaluated clinical analysis laboratories had at least one parameter that was not released in the customer's report despite being released by the hematological analyzers. The lack of knowledge on the part of professionals about the clinical importance of each parameter of the complete blood count results in a loss in patient assessment, and it is important to include these parameters in the complete blood count report.

Sampling data of fresh frozen plasma, cryoprecipitates and leukocyte-free platelet quality monitoring in Hebei Province from 2015 to 2021: a retrospective analysis / 中国输血杂志

【Objective】 To form the sampling data interval by retrospectively analyzing the sampling data of quality monitoring of fresh frozen plasma, cryoprecipitates and leukocyte-free platelets in all blood stations in Hebei Province during the past 7 years. 【Methods】 The data of blood component sampling from 12 blood station quality control laboratories in Hebei from 2015 to 2021 were collected. The FⅧ content and plasma protein content of fresh frozen plasma, the FⅧ content and fibrinogen content of cryoprecipitates, and the leukocyte residuals, red blood cell mixed and platelet content of leukocyte-free platelets were taken as the objects for discrete point and fitted curve analysis. 【Results】 The FⅧ level of fresh frozen plasma: (1.36±1.1) IU/mL, 5 blood stations showed a representative overall high or low or fluctuated characteristics; Fresh frozen plasm-plasma protein items: overall mean ±SD: (61.13±16.7) g/L, four blood stations showed scattered distribution or continuous high value scattered points; Cryoprecipitates FⅧ: the overall mean ±SD: (134.25±58.7) IU/mL, four blood stations showed the differentiation characteristics of continuous high, low or stable in the middle; Cryoprecipitates-fibrinogen items: the overall mean ±SD: (215.27±83.5) mg, five blood stations showed the overall high or low and fluctuated. Leukocyte-free apheresis platelet-to-leukocyte residual items: overall mean ±SD: 0.37±0.96 (×106/bag), two blood stations showed a relatively high representative overall characteristics, and the rest were concentrated between 0 and 1; The total mean ±SD of platelet-to-red blood cell mixture without leukocyte was 2.45±2.82 (×109/bag), with obvious segmented concentrated distribution, and scattered distribution in 3 blood centers. Platelet content: the overall mean ±SD was 3.14±1.55 (×1011/bag), many deviations were noticed in 3 blood stations, and 1 blood station showed representative overall high characteristics. 【Conclusion】 This analysis shows that the distribution status of each blood station in different items is similar. The distribution status of discrete point groups and the change trend of the concentrated part of the fitting curve show that there are some differences in the monitoring level between the quality control laboratories of each blood station, and the update of detection instruments and reagents and the selection of detection methods greatly affect the test results. The summary data presented the index interval framework formed in the past 7 years, which helped to understand the difference between the results of each laboratory, correct the accuracy of the test results, better play the guiding role of quality monitoring in the blood preparation process, and continue to enhance the standardization of the whole process of blood collection and supply in the province.

Desafios dos laboratórios públicos da área de saúde ambiental para implantação e manutenção dos requisitos de normativas da qualidade para monitoramento da água de consumo humano / Challenges for public laboratories in the environmental health area for implementation and maintenance of quality regulatory requirements for monitoring human consumption water

Resumo Introdução O Ministério da Saúde (MS) é responsável pela vigilância da qualidade da água de consumo humano. A confiabilidade nos resultados do monitoramento de parâmetros analíticos minimiza riscos à saúde pública. Objetivo Retratar aspectos funcionais, a aplicação de ferramentas da qualidade e a aderência dos laboratórios públicos que atuam no monitoramento da água de consumo humano aos requisitos da norma ABNT NBR ISO/IEC 17025. Método A pesquisa foi realizada com 30 laboratórios públicos de todas as regiões do país, respondendo a um questionário elaborado com 49 perguntas sobre a formação e capacidade dos profissionais, garantia da validade dos resultados e sobre a determinação de parâmetros da qualidade da água. Resultados Dos 161 profissionais, 46% possuem mais de 10 anos de experiência e 65% têm formação superior. Capacitações específicas foram requeridas por todos. A validação dos métodos analíticos não foi realizada por 59%. Materiais de referência certificados são acessados por 41% e apenas 18% têm facilidade em adquiri-los. A participação em ensaios de proficiência foi reportada por 68% dos laboratórios, mas com poucos parâmetros avaliados e dificuldades em contratar provedores. Conclusão Evidenciou-se a necessidade de ações para fortalecimento da metrologia em laboratórios públicos que atuam na vigilância da qualidade da água.

Abstract Background The Ministry of Health (MS) is responsible for drinking water quality surveillance. Reliability in the results of monitoring analytical parameters minimizes public health risks. Objective To present functionals aspects and the application of quality tools by public laboratories that work to monitor the quality of drinking water. Method A survey was conducted with 30 public laboratories from all regions of the country, answering a questionnaire elaborated with 49 questions about the training and capacity of professionals, guaranteeing the validity of the results and about the determination of basic parameters of water quality. Results Of the 161 professionals, 46% have more than 10 years of experience and 65% have higher education. Specific training was required by everyone. The validation of the analytical methods was not performed by 59%. Reference materials are accessed by 41% and only 18% can acquire them easily. Participation in proficiency tests was reported by 68% of the laboratories, but with few parameters evaluated and difficulties in hiring providers. Conclusion The need for actions to strengthen metrology in public laboratories that work in water quality surveillance was highlighted.

Evaluación externa de la calidad en laboratorios clínicos del nivel primario de la provincia Camagüey / External quality assessment in clinical laboratories of the primary health care in Camagüey

RESUMEN Introducción: La evaluación externa de la calidad es un procedimiento que compara los resultados de varios laboratorios que analizan la misma muestra, con el propósito de evaluar el desempeño analítico y asegurar la calidad. La provincia Camagüey fue incluida en forma permanente en el programa de evaluación externa de la calidad desde que se inició hasta que por diferentes dificultades nacionales y provinciales dicho programa no pudo continuar. Desde entonces, el comité de calidad de la provincia decidió organizar alternativas de evaluación con este propósito. En el 2016 se aplicó una nueva propuesta de evaluación en los laboratorios clínicos del nivel primario de atención. Objetivo: Evaluar la calidad de los resultados obtenidos en el procesamiento de los componentes de química clínica, en los laboratorios del nivel primario de la provincia Camagüey. Métodos: Se realizó un estudio descriptivo transversal desde septiembre de 2017 hasta julio de 2018, el universo estuvo constituido por todos los laboratorios clínicos de la provincia Camagüey y se trabajó con una muestra no probabilística de 14 laboratorios. Resultados: El desempeño analítico de colesteroles, glucemia y creatinina fue aceptable y los triglicéridos no aceptables, un policlínico del municipio Camagüey mostró el menor por ciento de error de medida de precisión y de exactitud. Conclusiones: Los resultados de los colesteroles mostraron los mejores desempeños analíticos y los resultados obtenidos fueron más exactos que precisos en los componentes evaluados. Fue elevado el por ciento de participación de los laboratorios 04 y 09 durante todo el tiempo que duró el estudio.

ABSTRACT Introduction: External quality assessment is a procedure that compares the results of several laboratories that analyze the same sample, with the purpose of evaluating analytical performance and assuring quality. Camagüey participated constantly in the external quality assessment program from the beginning until, due to different national and provincial difficulties, said program could not continue. Since then, the province(s quality committee decided to organize assessment alternatives for this purpose. In 2016, a new assessment proposal was applied in clinical laboratories al the primary level of care. Objective: To evaluate the quality of the results obtained in the processing of clinical chemistry components in primary level laboratories in the province of Camagüey. Methods: A cross-sectional descriptive study was carried out from September 2017 to July 2018, the universe consisted of all clinical laboratories in the province of Camagüey and a non-probabilistic sample of 14 laboratories was used. Results: The analytical performance of cholesterol, blood-glucose level and creatinine was acceptable and triglycerides were unacceptable. A polyclinic in the municipality of Camagüey showed the lowest percentage of precision and accuracy measurement error. Conclusions: The cholesterols results showed the best performances and the results obtained were more exact than precise in the evaluated components. The participation percentage of laboratories 04 and 09 was high throughout the duration of the study.

Contribuciones teóricas y prácticas a la formación y superación de profesionales vinculados al análisis clínico / Theoretical and practical contributions to the training and improvement of professionals linked to clinical analysis

RESUMEN Fundamento: las actuales condiciones de estudio y trabajo en las ciencias médicas exigen un óptimo trabajo de las instituciones formadoras y asistenciales para garantizar un egresado con profundas convicciones éticas y humanas. Objetivo: expresar las contribuciones teóricas y prácticas de una estrategia implementada para la formación y superación de profesionales vinculados al análisis clínico. Métodos: se realizó un estudio longitudinal retrospectivo y documental en el período enero 2013-diciembre 2019 en la Universidad de Ciencias Médicas de Camagüey. Se utilizaron métodos teóricos y empíricos: la revisión documental que permitió recopilar la información referente a las investigaciones realizadas en el periodo analizado; y de la estadística descriptiva e inferencial para el análisis y expresión de los resultados. Resultados: se corresponden con lo logrado en diferentes proyectos de investigación encaminados al perfeccionamiento de la formación inicial y de posgrado de estos profesionales. Incluyen: el establecimiento de asignatura del currículo optativo y la aplicación de materiales didácticos en la carrera de Bioanálisis Clínico, y asignatura del currículo propio en la de Análisis Clínico y Medicina Transfusional de ciclo corto. En el posgrado, un modelo teórico y una estrategia para la superación profesional del tecnólogo de la salud en Laboratorio Clínico desde la integración ciencias básicas biomédicas-laboratorio, y la implementación y evaluación del impacto del diplomado de Ciencias del Laboratorio. Conclusiones: la estrategia implementada contribuyó a perfeccionar el desempeño de los estudiantes en formación, y de los egresados, al disponer de un sistema de superación posgraduada.

ABSTRACT Background: current study and working conditions in medical sciences require optimal work from educational and care institutions to guarantee a graduate with deep ethical and human convictions. Objective: to express the theoretical and practical contributions of a strategy implemented for the training and improvement of professionals linked to clinical analysis. Methods: a retrospective and documentary longitudinal study was carried out from January 2013 to December 2019 at Camagüey University of Medical Sciences. Theoretical and empirical methods were used: the documentary review that made it possible to collect the information regarding the investigations carried out in the analyzed period; and descriptive and inferential statistics for the analysis and expression of the results. Results: they correspond to what has been achieved in different research projects aimed at improving the initial and postgraduate training of these professionals. They include: the establishment of an optional curriculum and the application of didactic materials in the Clinical Bio-analysis degree, and a subject from the own curriculum in the Short-cycle Clinical Analysis and Transfusion Medicine. In the postgraduate course, a theoretical model and a strategy for the professional improvement of the health technologist in the Clinical Laboratory from the integration of basic biomedical-laboratory sciences, and the implementation and evaluation of the impact of the Laboratory Sciences diploma course. Conclusions: the implemented strategy contributed to improve the performance of students at training, and graduates, by having a postgraduate improvement system.

Satisfacción con la introducción del nuevo procedimiento de evaluación de riesgo biológico en laboratorios clínicos

Introducción: La evaluación de la satisfacción respecto al cambio introducido en el procedimiento de evaluación de riesgo biológico, aporta elementos para valorar su efectividad. Objetivo: Evaluar mediante la Técnica de Iadov el nivel de satisfacción como usuario del procedimiento de evaluación del riesgo biológico en laboratorios clínicos con enfoque en defensa en profundidad. Métodos: Se realizó un estudio descriptivo de corte transversal desde julio a diciembre del año 2021. El universo estuvo constituido por los 82 laboratorios clínicos de atención primaria de salud de La Habana y se trabajó con una muestra no probabilística de tres laboratorios con un total de 37 trabajadores; a partir de los criterios de inclusión: ser trabajador del laboratorio y aceptar participar en la investigación, como criterios de exclusión: personal de otros centros en prestación de servicio y alumnos en formación. Se utilizó el método de investigación empíricos (encuesta) y como método estadístico se utilizó el análisis porcentual. El procesamiento de la información se realizó mediante la Técnica de Iadov. Resultados: La encuesta de satisfacción reveló que el 78,6 % de la muestra expresó una máxima satisfacción, el 24,3 % más satisfecho que insatisfecho. Las preguntas abiertas (dos y cuatro de la encuesta) identificaron como aspecto que más gustaron, el propósito e interés de mejorar la etapa evaluación y gestión de riesgo, las etapas sucesivas del procedimiento permiten obtener una información detallada del estado de la bioseguridad y entre los aspectos que no gustaron se describe el análisis matemático. El índice de satisfacción grupal obtenido fue de 0,87. Conclusiones: El índice de satisfacción grupal de trabajadores de los laboratorios clínicos donde se aplicó el procedimiento de evaluación de riesgo biológico fue alto, lo que refleja la aceptación de la propuesta y reconocimiento de su pertinencia en el proceso de evaluación del riesgo biológico.

Introduction: The evaluation of satisfaction regarding the change introduced in the biological risk assessment procedure provides elements to assess its effectiveness. Objective: To evaluate through the Ladov technique the level of satisfaction as a user of the biological risk assessment procedure in clinical laboratories with a focus on defense in depth. Methods: A descriptive cross-sectional study was carried out in the period from July to December 2021. The universe consisted of the 82 clinical laboratories of primary health care in Havana and a non-probabilistic sample of 3 laboratories with a total of 37 workers; based on the inclusion criteria: being a laboratory worker and agreeing to participate in the research, as exclusion criteria: personnel from other centers providing services and students in training. The empirical research method (survey) was used and the percentage analysis was used as a statistical method. The processing of the information was carried out using the V.A. Iadov. Results: The satisfaction survey revealed that 78.6% of the sample expressed maximum satisfaction, 24.3% more satisfied than dissatisfied. The open questions (2 and 4 of the survey) identified as the aspect that they liked the most, the purpose and interest of improving the risk assessment and management stage, the successive stages of the procedure that allow obtaining detailed information on the state of biosafety y and among the aspects that they did not like, the mathematical analysis is described. The group satisfaction index obtained was 0.87. Conclusions: The group satisfaction index of clinical laboratory workers where the biological risk assessment procedure was applied was high, reflecting acceptance of the proposal and recognition of its relevance in the biological risk assessment process.

The application of sigma metrics in the laboratory to assess quality control processes in South Africa

Objective: This study aimed to determine the sigma metrics of analytes when using different total allowable error guidelines.Methods: A retrospective analysis was performed on 19 general chemistry analytes at Charlotte Maxeke Johannesburg Academic Hospital in South Africa between January 2017 and December 2017. Sigma metrics were calculated on two identical analysers, using internal quality control data and total allowable error guidelines from the Ricos biological variation database and three alternative sources (the Royal College of Pathologists of Australasia, the Clinical Laboratory Improvements Amendment, and the European Federation of Clinical Chemistry and Laboratory Medicine). Results: The sigma performance was similar on both analysers but varied based on the guideline used, with the Clinical Laboratory Improvements Amendment guidelines resulting in the best sigma metrics (53% of analytes on one analyser and 46% on the other had acceptable sigma metrics) and the Royal College of Pathologists of Australia guidelines being the most stringent (21% and 23%). Sodium and chloride performed poorly across all guidelines (sigma < 3). There were also month-to-month variations that may result in acceptable sigma despite poor performance during certain months.Conclusion: The sigma varies greatly depending on the total allowable error, but could be a valuable tool to save time and decrease costs in high-volume laboratories. Sigma metrics calculations need to be standardised

Application of delta checks in clinical laboratories / 中华检验医学杂志

The delta checks are one of the patient-based quality control options to identify the errors and the significant changes in patients′ condition. Compared with the traditional internal quality control method, the delta checks have the characteristics of real-time monitoring, with no additional detecting cost, thus the delta checks are widely used in clinical laboratories. In addition, the delta checks are also useful in the auto-verification system to screen out the abnormal results for manual verification. This article reviewed the delta checks′ development history, parameters selection, application values in quality control and auto-verification.

Major changes will take place on ISO15189 "Medical laboratories: requirements for quality and competence" / 中华检验医学杂志

Since the first edition of ISO15189"Medical laboratories: requirements for quality and competence" was published in 2003, it has been rapidly and widely used in the world under the promotion of the International Laboratory Accreditation Cooperation Organization (ILAC), and has become the basic standard for the quality management, capacity-building and capacity attestation of medical laboratories. The Mutual Recognition Arrangement (MRA) of ILAC for ISO15189 is the most authoritative international permit for examination results, which is accepted by international organizations. Since the establishment of ISO15189 medical laboratory accreditation system in 2004 in China, more than 530 medical laboratories have been accredited, which plays an important role in improving the quality and competence of medical laboratories in China, and improves the influence of Chinese medical laboratories in the world. ISO 15189:2012 is currently being revised by the International Organization for Standardization/Technical Committee on Clinical Laboratory Testing and in vitro diagnostic test systems (ISO/TC212). This revision will bring significant changes and the medical laboratory shall pay attention to these changes. In order to help medical laboratories understand the new ideas in advance, this paper summarizes and analyses the draft of the new international standards, and provides references for users.

Enfermedad por coronavirus 2019 (COVID-19) / Coronavirus Disease 2019 (COVID-19) / Doença Por Coronavírus 2019 (COVID-19)

La infección respiratoria causada por el SARS-CoV-2 fue declarada pandemia por la OMS en marzo 11 de 2020. Este nuevo beta-coronavirus, producto probablemente de la mutación aleatoria de un coronavirus infectante de animales, ha impactado la humanidad, creado una gran mortalidad entre la población, y también ha desestabilizado la interacción entre los seres humanos y su calidad de vida. El trabajo conjunto de investigadores que han analizado los casos de COVID-19, los mecanismos biológicos, los efectos en el ser humano y las posibles vías de intervención conducen a exitosos avances científicos en el entendimiento de la infección, la creación de inmunidad y el uso de ciertos medicamentos, además de una novedosa e histórica forma de creación de nuevas vacunas eficientes y seguras. No se puede olvidar el esfuerzo en medidas de protección personal como el lavado de manos, higiene de superficies, distanciamiento social y equipos de protección, entre otras. En esta revisión narrativa analizamos algunos puntos importantes en el proceso infeccioso, manifestaciones clínicas, diagnóstico, manejo y prevención de la enfermedad por coronavirus 2019, COVID-19.

The respiratory infection caused by SARS-CoV-2 was declared a pandemic by the WHO on March 11, 2020. This new beta-coronavirus, probably the product of the random mutation of a coronavirus infecting animals, has affected humanity, created great mor-tality among the population, and it has also destabilized the interaction between human beings and their quality of life. The joint work of researchers who have analyzed the COVID-19 cases, the biological mechanisms, their effects on human beings, and possible intervention pathways have led to successful scientific advances in the understanding of the infection, the creation of immunity, the use of specific medications, in addition to an innovative and historical way of creating new vaccines that are both efficient and safe. It is also crucial to note that the effort to produce positive results involves the continued used of safety precautions such as handwashing, surface disinfection, social distancing and protective equipment, among others. This narrative review will analyze relevant aspects regarding the process of infection, clinical manifestations, diagnosis, management, and prevention of the disease caused by the 2019 coronavirus, COVID-19.

A infecção respiratória causada pelo SARS-CoV-2 foi declarada pandemia pela OMS em 11 de março de 2020. Este novo beta-coronavírus, provavelmente produto da mutação aleatória de um coronavírus que infecta animais, impactou a humanidade, criou uma grande mortalidade entre a população, e também desestabilizou a interação entre o ser humano e sua qualidade de vida. O trabalho conjunto de investigadores que anali-saram os casos de COVID-19, os mecanismos biológicos, os efeitos no ser humano e as possíveis vias de intervenção conduzem a avanços científicos exitosos na compreensão da infecção, na criação de imunidade e na utilização de certos medicamentos, além de uma forma nova e histórica de criar novas vacinas eficientes e seguras. Não se pode esquecer o esforço em medidas de proteção individual como lavagem das mãos, higiene das superfícies, distanciamento social e equipamentos de proteção, entre outros. Nesta revisão narrativa analisamos alguns pontos importantes no processo infeccioso, manifes-tações clínicas, diagnóstico, manejo e prevenção da doença coronavírus 2019, COVID-19.

Cumplimiento de las normas de bioseguridad en laboratorios de la Universidad Técnica de Machala / Fulfillment of the biosafety norms in laboratories of the Universidad Técnica de Machala

Establecer el cumplimiento de las normas de bioseguridad por parte de los profesionales que laboran en los laboratorios de la Facultad de Ciencias Químicas y de la Salud de la Universidad Técnica de Machala. Materiales y Métodos: La presente investigación es de tipo descriptiva, con enfoque cuantitativo. La modalidad de la investigación es de campo. La población estuvo constituida por 100 estudiantes que usan los diferentes laboratorios de la Facultad de Ciencias Químicas y de la Salud de la Universidad Técnica de Machala. Resultados: El 59% de la población contestó que sí, ha recibido capacitación acerca de las normas de bioseguridad en la institución y el 41% respondieron que no. El 73% de los estudiantes cumplen con las medidas de bioseguridad en el laboratorio. Se realiza el lavado de manos, con un equivalente a un 39% para Después de tener contacto con cualquier tipo de materiales, muestras biológicas, productos sólidos, sustancias o reactivos. Sobre si se cuentan con recipientes de descarte para elementos contaminados, y están debidamente identificados el cual corresponde a un 46,9%. A la pregunta sobre qué materiales se deposita en los guardianes dando un equivalente de 43% para las Jeringuillas, bisturí, sin embargo, las Lancetas, agujas. Conclusiones: Se pudo determinar que la gran parte de la población estudiada si cumplen con las normas de bioseguridad(AU)

To establish compliance with Biosafety standards by professionals working in the laboratories of the Faculty of Chemistry and Health Sciences of the Technical University of Machala. Materials and Methods: This is a descriptive research with a quantitative approach. The modality of the research is field research. The population consisted of 100 students who use the different laboratories of the Faculty of Chemistry and Health Sciences of the Technical University of Machala. Results: 59% of the population answered that they had received training on Biosafety norms in the institution and 41% answered that they had not. Seventy-three percent of the students comply with Biosafety measures in the laboratory. Hand washing is performed, with an equivalent of 39% for after having contact with any type of materials, biological samples, solid products, substances or reagents. Regarding whether there are disposal containers for contaminated items, and whether they are properly identified, this corresponds to 46.9%. To the question about what materials are deposited in the guards giving an equivalent of 43% for syringes, scapel powever, Lancets, needles. Conclusions: It could be determined that the great part of the population studied if they comply with Biosafety standards

Laboratório de habilidades e simulação clínica em época de Covid-19: possibilidades e recomendações práticas / Skills and clinical simulation laboratory in times Covid-19: possibilities and practical recommendations

RESUMO: Este artigo teve por objetivo refletir sobre as possibilidades do laboratório de habilidades e simulação clínica enquanto espaço potencial para o treino e desenvolvimento de competências e habilidades no ensino em saúde, além de compartilhar estratégias para o planejamento docente e para o uso desses espaços em tempos de pandemia pela COVID-19. Estudo descritivo, exploratório e qualitativo realizado a partir da consulta a protocolos de recomendações sanitárias, diretrizes/planejamento de universidades públicas nacionais e internacionais para o retornodas atividades acadêmicas práticas em cursos da área da saúde e a opinião de especialistas em simulação clínica. São compartilhadas orientações específicas e comuns considerando os tipos de simulação propostas, estratégias de apoio às experiências clínicas simuladas, além de diretrizes sanitárias. Trata-se de recomendações que devem ser discutidas e adaptadas conforme as diferentes realidades, atualização de diretrizes sanitárias dos órgãos de saúde e educação, além do monitoramento do comportamento da pandemia causada pelo coronavírus em todo o mundo. (AU)

ABSTRACT: This article aimed to reflect on the possibilities of the skills laboratory and clinical simulation as a potential space for training and development of skills and abilities in health education, in addition to sharing strategies for teaching planning and the use of these spaces in times of the COVID-19 pandemic. A descriptive, exploratory, qualitative study based on the consultation of health recommendation protocols, guidelines/planning of national and international public universities for the return of practical academic activities in health area courses and the opinion of experts in clinical simulation. Specific and common guidelines are shared considering the types of simulation proposed, strategies to support simulated clinical experiences, and health guidelines. These recommendations should be discussed and adapted according to the different realities, updating health and education agencies' health guidelines, besides monitoring the pandemic's behavior caused by the coronavirus world. (AU)

Resistencia a la fractura de coronas dentales fabricadas análogamente vs tecnología cad-cam. Estudio In vitro / Fracture resistance of analogally made dental crowns vs cad-cam technology. In vitro study

Resumen Antecedentes. La resistencia a la fractura de las coronas puede tener influencia en su ocurrencia, de acuerdo con el método de fabricación usado, ya sea análogamente o por medio de tecnología Cad-Cam. Objetivo. Comparar la resistencia a la fractura de las coronas individuales realizadas por dos métodos de fabricación, bajo diseño asistido por ordenador y fabricación computarizada (CAD-CAM) e inyectadas. Método. Estudio in vitro. Tamaño de la muestra 20 coronas en dos grupos: 10 coronas bajo tecnología CAD-CAM y 10 coronas inyectadas. Fueron sometidas a cargas compresivas en una máquina de ensayos universal, con una velocidad de 1mm/min y una carga de celda de 5kN hasta obtener la fractura máxima de estas. Los datos se analizaron estadísticamente utilizando las pruebas Shapiro Wilk, Mann Whitney p=0,05. Resultados. Las coronas fabricadas por Cad-Cam obtuvieron un mínimo de 602,5 Newton y un máximo de 1093 Newton, mientras que las coronas fabricadas análogamente obtuvieron un mínimo de 525,2 Newton y un máximo de 1773 Newton en el experimento con la máquina de ensayo universal para lograr su fractura. Se obtuvo una diferencia significativa en la prueba de resistencia a la factura entre ambos métodos de fabricación (p <0,001). Conclusión. Las coronas de Disilicato de litio Prensadas obtuvieron una mayor resistencia a la fractura que las coronas fabricadas via CAD-CAM.

Abstract Background. The fracture resistance of the crowns may have an influence on their appearance, according to the method of making them, either analogously or by means of Cad-Cam technology. Objective. To compare the resistance to the fracture of the individual crowns made by two manufacturing methods, under computer-aided design and computerized manufacturing (CAD-CAM) and injected. Methods. In vitro study. Sample size 20 crowns in two groups: 10 crowns using CAD-CAM technology and 10 crowns injected. Crowns were subjected to compressive loads in a universal testing machine, with a speed of 1mm / min and a cell load of 5kN until obtaining the maximum bill for these. Data were statistically analyzed using the Shapiro Wilk tests, Mann Whitney p = 0.05. Results. Crowns manufactured by Cad-Cam obtained a minimum of 602.5 Newton and a maximum of 1093 Newton, while the crowns manufactured analogously obtained a minimum of 525.2 Newton and a maximum of 1773 Newton in the experiment with the machine Universal test to achieve their fracture. A significant difference was obtained in the invoice resistance test between both manufacturing methods (p <0.001). Conclusion. Pressed Lithium Disilicate crowns obtained higher fracture resistance than crowns under design and manufacturing by computer (CAD-CAM).

Experiencia organizativa del Centro de Investigaciones Científicas de la Defensa Civil en el diagnóstico de la COVID-19 / Organizational experience of the Civil Defense Scientific Research Center in the diagnosis of COVID-19

El enfrentamiento a la epidemia de la COVID-19 en Cuba, ha requerido el desarrollo de nuevas capacidades para su diagnóstico en los laboratorios de biología molecular de diferentes instituciones científicas y de salud. El objetivo de este trabajo es mostrar la experiencia del Centro de Investigaciones Científicas de la Defensa Civil en la organización del diagnóstico de la COVID-19. Se revisaron documentos rectores del trabajo del centro, su programa de bioseguridad y los reportados por la Organización Mundial de la Salud para el enfrentamiento a la pandemia. Se expone la experiencia de la estructura adoptada por la entidad para asegurar el diagnóstico de forma ininterrumpida, las funciones del grupo de dirección y la secuencia de las actividades desarrolladas. Se destaca la capacitación del personal en la gestión de riesgos biológicos y las medidas de prevención adoptadas. El uso adecuado de los medios de protección colectivos e individuales, la manipulación segura de las muestras biológicas y la cooperación con otras entidades, han permitido el cumplimiento de la tarea encomendada, sin la ocurrencia de accidentes que comprometan la salud del personal que labora en el diagnóstico, ni afectaciones a la comunidad y al medio ambiente(AU)

Facing the COVID-19 epidemic in Cuba has required the development of new capacities for its diagnosis in the molecular biology laboratories of different scientific and health institutions. The objective of this work is to show the experience of the Cuban Civil Defense Scientific Research Center in organizing the diagnosis of COVID-19. Guiding documents for the Center's work, its biosafety program, and those reported by the World Health Organization for dealing with the pandemic were reviewed. The experience of the structure adopted by the entity to ensure an uninterrupted diagnosis, the functions of the Steering Group and the sequence of activities carried out is exposed; highlighting the training of personnel in the management of biological risks and the prevention measures adopted. The proper use of collective and individual protection means, the safe handling of biological samples and cooperation with other entities, have allowed the fulfillment of the entrusted task, without the occurrence of accidents that compromise the health of the personnel working in the diagnosis, nor effects on the community and the environment(AU)