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Resumen Los programas de estandarización de creatinina mantienen su vigencia. El objetivo es describir la experiencia adquirida durante el desarrollo de un programa de estandarización de creatinina en una provincia de bajos recursos y mostrar los aspectos que se deben considerar para su escalabilidad en un contexto semejante. El programa se desarrolló en etapas: en la primera (2010) se realizó el relevamiento de 49 laboratorios clínicos (LC) distribuidos en toda la provincia del Chaco, Argentina. En la segunda (2012) se ajustó el error aleatorio (EA) aplicando protocolos internacionales (CLSI EP-5A). En la tercera etapa (2014-2015) se procesaron paneles de sueros con concentraciones asignadas por un método trazable al de referencia y al estándar internacional (CG-IDMS). Se aplicaron protocolos internacionales para evaluar el error total (ET) de la determinación en cada laboratorio (CLSI EP-10A). En 2016, aplicando herramientas de calidad, se evaluaron las barreras en el proceso. Se observó en el EA: para un nivel de 1,00 mg/dL, ningún LC alcanzó los niveles deseables; para un nivel de 2,5 mg/dL solo 9 (23%) los alcanzaron. Concluida la segunda y tercera etapa, solo 18 laboratorios (48,7%) lograron ajustar el EA y/o ET, pero resultó dificultoso sostenerlo en el tiempo. Los reactivos, calibradores y controles son producidos por la industria y depende del estado el control de los mismos. La homogeneidad del equipamiento depende de la accesibilidad económica y del volumen de trabajo. El medio ambiente, la temperatura y la calidad del agua siguen siendo una dificultad para la escalabilidad.
Abstract Creatinine standardisation programmes remain valid. The objective of this work is to describe the experience acquired during the development of a creatinine standardisation programme in a low-resource province and show the aspects that should be considered for its scalability in a similar context. The programme was developed in stages. The first one was carried out in 2010. It consists of a structured survey completed by 49 clinical laboratories (CL) distributed throughout the province. In the second stage (2012) the random error (RE) was adjusted by applying international protocols (CLSI EP-5A). In the third stage (2014-2015), panels of sera were processed with concentrations assigned by a method traceable to the reference and the international standard (CG-IDMS). International protocols were applied to evaluate the total error (TE) of the determination in each laboratory (CLSI EP-10A). In 2016, applying quality tools, the barriers in the process were evaluated. In the RE, it was observed: for a level of 1.00 mg/dL, no CL reached the desirable levels; for a level of 2.5 mg/dL only 9 (23%) CL achieved them. Once the second and third stages were completed, only 18 laboratories (48.7%) managed to adjust the RE and/or TE, but it was difficult to sustain it over time. With respect to materials, reagents, calibrators, and controls, they are produced by the industry depending on the state of their control. The homogeneity of the equipment depends on economic accessibility and volume of work. The environment, temperature, and water quality are a barrier to scalability.
Resumo Os programas de padronização da creatinina permanecem válidos. O objetivo é descrever a experiência adquirida durante o desenvolvimento de um programa de padronização de creatinina em uma província com poucos recursos e mostrar os aspectos que devem ser levados em consideração para sua escalabilidade em um contexto semelhante. O programa foi desenvolvido em etapas: Na primeira (2010), foi realizado um levantamento de 49 laboratórios clínicos (LC) distribuídos em toda a provincia do Chaco, na Argentina. Na segunda etapa (2012) o erro aleatório (EA) foi ajustado através da aplicação de protocolos internacionais (CLSI EP-5A). Na terceira etapa (2014-2015), foram processados paineis de soros com concentrações atribuídas por método rastreável à referência e ao padrão internacional (CG-IDMS). Protocolos internacionais foram aplicados para avaliar o erro total (ET) da determinação em cada laboratório (CLSI EP-10A). Em 2016, aplicando ferramentas de qualidade, foram avaliadas as barreiras no processo. Observou-se na EA: para o nível de 1,00 mg/dL nenhuma LC atingiu os níveis desejáveis; para um nível de 2,5 mg/dL, apenas 9 (23%) os atingiram. Concluídas a segunda e terceira etapas, apenas 18 laboratórios (48,7%) conseguiram ajustar o EA e/ou o ET, mas foi difícil sustentá-lo ao longo do tempo. No que diz respeito aos reagentes, calibradores e controles, eles são produzidos pela indústria. dependendo do estado o seu controle. A homogeneidade do equipamento depende da acessibilidade econômica e do volume de trabalho. O meio ambiente, a temperatura e a qualidade da água continuam sendo uma dificuldade para a escalabilidade.
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Los resultados de los exámenes que se realizan en el laboratorio clínico deben constituir una parte esencial en la evaluación de los sujetos incluidos en los ensayos clínicos para la introducción de nuevos medicamentos. En este artículo se describen los aspectos más importantes del trabajo en el laboratorio durante el desarrollo de un ensayo donde se emplean nuevas tecnologías. Los ensayos clínicos no solo mejoran los indicadores de salud de la población, sino que, además, exigen los mejores estándares de diagnóstico y evaluación del tratamiento, a través de nuevas tecnologías, donde se incluye el laboratorio clínico.
The results of the exams that are carried out in the clinical laboratory should constitute an essential part in the evaluation of people included in clinical trials for the introduction of new medications. In this article the most important aspects of work in the laboratory are described, during the development of a trial where new technologies are used. Clinical trials not only improve health indicators of the population, but also, demand the best diagnosis standards and evaluation of the treatment, through new technologies, where clinical laboratory is included.
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Background: Standardising procedures is the best way to harmonise and strengthen the quality of laboratory-based antimicrobial resistance surveillance. Since 2018, Burkina Faso has developed and disseminated the national manual of procedures for performing antibiotic susceptibility tests in sentinel laboratories within its national antimicrobial resistance surveillance network. Objective: Our study aimed to assess these sentinel laboratories' compliance with good practices for antibiotics susceptibility tests. Methods: Four teams evaluated the antimicrobial resistance sentinel sites laboratories throughout Burkina Faso from 19 to 28 September 2022. Eighteen out of 19 sentinel laboratories were evaluated. A four-member technical committee designed and validated the evaluation tool composed of three Microsoft Excel sheets. The evaluation emphasised quality controls for culture media, antibiotic discs and compliance with antimicrobial susceptibility testing procedures by the laboratories. Excel software was used for data recording and graphs and table design. The free R software version 4.2.0 was used for descriptive statistics. An overall score below 80% was considered noncompliance. Results: Most (83.33%) of the sentinel laboratories conducted at least one quality control activity for culture media, and 66.67% conducted at least one quality control activity for antibiotic discs. Over three-quarters (76.47%) of the laboratories were more than 80% compliant with the modified Kirby Bauer antimicrobial susceptibility testing method. Conclusion: The evaluation revealed the noncompliance of sentinel laboratories with the national procedure manual, particularly in the quality control component. What this study adds: This study has provided baseline data on the sentinel laboratories' compliance with the national antimicrobial susceptibility testing procedures manual, particularly in areas performing quality control checks or meeting quality indicators for culture media and antibiotic discs.
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Humains , Mâle , Femelle , Guides de bonnes pratiques cliniques comme sujetRésumé
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.
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Laboratoires cliniques , Étudiants , Enseignement médical , Corps enseignant , Histoire de la médecineRésumé
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.
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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)
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Humains , Aptitude , Maladies de la peau/diagnostic , Enseignement , Enseignement professionnel , Formation Professionnelle , Stage interdisciplinaire/méthodes , Compétence professionnelle , Plans et Programmes de Santé , Épidémiologie Descriptive , Dermatologie/enseignement et éducationRésumé
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.
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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.
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【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.
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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.
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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.
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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.
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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
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Contrôle de qualité , Anatomopathologie , Management par la qualité , Tests de chimie clinique , Erreurs de diagnostic , LaboratoiresRésumé
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.
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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.
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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.
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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.
Résumé
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.
Sujets)
Stratégies de Santé , Recherche , , Enseignement médical , LaboratoiresRésumé
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.
Sujets)
Humains , SARS-CoV-2 , COVID-19 , Dispositifs de protection , Signes et symptômes , Organisation mondiale de la santé , Vaccins , Désinfection des mains , Mortalité , Coronavirus , Distanciation physique , ImmunitéRésumé
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