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Introduction: Although the United States and other countries have implemented comprehensive legislation, regulations, and policies to support biosafety and biosecurity of high- and maximum-containment laboratories, Brazil's legislation has notable gaps and inconsistencies. Objective: To evaluate the Brazilian approach to ensuring nationwide biosafety and biosecurity oversight and governance of high- and maximum-containment laboratories. Methods: A systematic gap analysis was conducted to compare Brazilian biosafety and biosecurity legislation, regulations, and policies with their international counterparts, with a particular focus on the oversight and governance of high- and maximum-containment laboratories. Results: We found that Brazilian biosafety and biosecurity legislation, regulations, and policies have relevant gaps. Governance and regulatory oversight of Brazil's high- and maximum-containment laboratories are decentralized with variable levels of adherence to commonly accepted global biosafety and biosecurity compliance standards. These findings represent a limitation not only to governance but also to the preparedness to face current and future challenges related to emergent infectious diseases in Brazil. Enhancing the Brazilian legal framework on laboratory biosafety and biosecurity is necessary and urgent. Reviewing the lessons learned and regulations applied in the United States and other international frameworks helped identify potential areas for improving Brazil's ability to inventory and manage its diverse biocontainment laboratory capabilities and assure these valuable resources align with national needs and priorities. Conclusion: The Brazilian government has an opportunity to revise and improve upon a national set of legislation, regulations, and policies for its high- and maximum-containment laboratories, taking advantage of legislation and guidelines published by other countries.

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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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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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Introducción: Garantizar la obtención de resultados analíticos de calidad en el trabajo de los laboratorios clínicos resulta de vital importancia, de ahí se infiere la necesidad de formar profesionales competentes que dominen y pongan en práctica la normativa nacional e internacional vigente relacionada con la calidad, el papel de la función calidad es hacer que ésta sea un aspecto inseparable del desempeño y la responsabilidad de cada empleado. Objetivo: Establecer el procedimiento para el desarrollo de la gestión de la función calidad en los laboratorios clínicos docentes. Métodos: Se realizó una investigación en sistemas y servicios de salud, en la cual se aplicaron técnicas y herramientas propias de la ciencia aplicada de la calidad. Resultados: Diseño de un procedimiento, con su representación en forma de diagrama de flujo con la explicación de los pasos incluidos en él, posteriormente se describe el procedimiento para garantizar su adecuación y aplicabilidad en cualquier institución que así lo considere pertinente. Conclusiones: El procedimiento diseñado para el desarrollo de la función calidad establece la secuencia lógica de pasos a seguir para lograr su implementación(AU)

Introduction: Guaranteeing procurement of quality analytical results in the work of clinical laboratories is of vital importance, hence the need to train competent professionals who master and put into practice the current national and international regulations related to quality. The role of the quality function is to make this an inseparable aspect of the performance and responsibility of each employee. Objective: To establish the procedure for the development of quality function management in teaching clinical laboratories. Methods: Research was carried out on health systems and services, in which techniques and tools from applied quality science were applied. Results: Design of a procedure was achieved with representation in the form of a flow chart with the explanation of the steps included in it. Then the procedure is described to guarantee adequacy and applicability in any institution that considers it relevant. Conclusions: The procedure designed for the development of the quality function establishes the logical sequence of steps to follow to achieve its implementation(AU)

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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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Introduction. Brazil was one of the most affected countries by the COVID-19 pandemic. Instituto Adolfo Lutz (IAL) is the reference laboratory for COVID-19 in São Paulo, the most populous state in Brazil. In April 2020, a secondary diagnostic pole named IAL-2 was created to enhance IAL's capacity for COVID-19 diagnosis.Hypothesis/Gap Statement. Public health laboratories must be prepared to rapidly respond to emerging epidemics or pandemics.Aim. To describe the design of IAL-2 and correlate the results of RT-qPCR tests for COVID-19 with secondary data on suspected cases of SARS-CoV-2 infection in the São Paulo state.Methodology. This is a retrospective study based on the analysis of secondary data from patients suspected of infection by SARS-CoV-2 whose clinical samples were submitted to real-time PCR after reverse transcription (RT-qPCR) at IAL-2, between 1 April 2020 and 8 March 2022. RT-qPCR Ct results of the different kits used were also analysed.Results. IAL-2 was implemented in April 2020, just over a month after the detection of the first COVID-19 case in Brazil. The laboratory performed 304,250 RT-qPCR tests during the study period, of which 98 319 (32.3 %) were positive, 205827 (67.7 %) negative, and 104 (0.03 %) inconclusive for SARS-CoV-2. RT-qPCR Ct values≤30 for E/N genes of SARS-CoV-2 were presented by 79.7 % of all the samples included in the study.Conclusion. IAL was able to rapidly implement a new laboratory structure to support the processing of an enormous number of samples for diagnosis of COVID-19, outlining strategies to carry out work with quality, using different RT-qPCR protocols.

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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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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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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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Many inconclusive diagnoses have been reported in studies carried out in veterinary diagnostic laboratories (VDLs). These inconclusive diagnoses are often associated with field veterinarians sending tissue samples and carcasses for histopathological examination. The use of social media in care has the potential as a tool for improvements in animal health. We evaluated the improvement in the rate of conclusive diagnoses in the VDL when using a messaging application for smartphones as a guidance tool for field veterinarians to refer animals and sample tissues for necropsy and histopathology. Veterinarians contacted the VDL team via a messaging app and forwarded videos, images, and clinical-epidemiological history. Based on this information, guidelines were created in real-time for contacting professionals about methods for collecting samples during necropsy and making diagnoses and scheduling visits to properties. The data obtained showed that smartphone messaging applications could be useful tools to expand the performance of VDLs and improve their diagnostic efficiency, especially when sending samples of animals that died is impossible due to certain sanitary conditions.

Muitos diagnósticos inconclusivos têm sido relatados em estudos realizados em laboratórios de diagnóstico veterinário (LDVs). Esses diagnósticos inconclusivos são frequentemente associados a veterinários de campo que enviam amostras de tecidos e carcaças para exame histopatológico. O uso das mídias sociais com cuidado tem potencial como ferramenta para melhorias na saúde animal. Avaliamos a melhora na taxa de diagnósticos conclusivos no LDV ao utilizar um aplicativo de mensagens para smartphones como ferramenta de orientação para veterinários de campo encaminharem animais e amostras de tecidos para necropsia e histopatologia. Os veterinários entraram em contato com a equipe do L por meio de um aplicativo de mensagens e encaminharam vídeos, imagens e histórico clínico-epidemiológico. Com base nessas informações, foram criadas orientações em tempo real para contato dos profissionais sobre métodos de coleta de amostras durante a necropsia e realização de diagnósticos, além do agendamento de visitas às propriedades. Os dados obtidos mostraram que os aplicativos de mensagens para smartphones podem ser ferramentas úteis para ampliar o desempenho dos VDLs e melhorar sua eficiência diagnóstica, principalmente quando o envio de amostras de animais que morreram é impossível devido a determinadas condições sanitárias.

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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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The 1968 Olympic Games in Mexico included innovative practices and technological knowledge of human biology. The first time that cytogenetic techniques had been applied to athletes was in the 1966 European Athletics Championship in Budapest and used on Olympic athletes for the first time in Mexico in 1968. The Genetics and Human Biology Program (Programa de Genética y Biología Humanas, PGBH) was created for this purpose in 1966 in close collaboration with the Local Organizing Committee (Comité Organizador, CO), by Mexican geneticists Alfonso León de Garay and Rodolfo Félix Estrada who led the project. The main objective was to study the genetic and anthropological components which determine an Olympic athlete's abilities. This investigation studied 1,265 game participants and included family studies, cytological analyses, research on single genes, and the study of sex determination. In terms of influence beyond Mexico, this Program was significant as a site of transnational collaboration. It mobilized cognitive and financial resources, scientific practices, and material culture to set up a clinical laboratory in the Olympic Village. The Program also hosted three international seminars in Mexico City, two before the games, to calibrate clinical trials and anthropological tests. One in 1969 to analyze the results and proceed to their publication in 1974. This manuscript will focus on the PGBH to show how its work fits in the larger tapestry of post-1945 human biological studies. Also, to explore how the Olympic athlete populations studied can be considered laboratories of knowledge production or sites of cognition conceived as specific entities for scientific inquiry, standardization of medical practices, and the production or application of medicines. Finally, through the narrative of the different trajectories and collaborations of the leaders of the PGBH, this manuscript will show how contact between their scientific practices brought cytogenetics and sports together.

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The emergence of the COVID-19 pandemic reinforced the central role of the One Health (OH) approach, as a multisectoral and multidisciplinary perspective, to tackle health threats at the human-animal-environment interface. This study assessed Brazilian preparedness and response to COVID-19 and zoonoses with a focus on the OH approach and equity dimensions. We conducted an environmental scan using a protocol developed as part of a multi-country study. The article selection process resulted in 45 documents: 79 files and 112 references on OH; 41 files and 81 references on equity. The OH and equity aspects are poorly represented in the official documents regarding the COVID-19 response, either at the federal and state levels. Brazil has a governance infrastructure that allows for the response to infectious diseases, including zoonoses, as well as the fight against antimicrobial resistance through the OH approach. However, the response to the pandemic did not fully utilize the resources of the Brazilian state, due to the lack of central coordination and articulation among the sectors involved. Brazil is considered an area of high risk for emergence of zoonoses mainly due to climate change, large-scale deforestation and urbanization, high wildlife biodiversity, wide dry frontier, and poor control of wild animals' traffic. Therefore, encouraging existing mechanisms for collaboration across sectors and disciplines, with the inclusion of vulnerable populations, is required for making a multisectoral OH approach successful in the country.

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INTRODUCTION: The first external quality assessment (EQA) in Thrombosis and Haemostasis was elaborated over 20 years ago, and since then, several national and international EQA institutions have been established. AIM: Display the benefits of EQA programs. METHODS: The spectrum of EQA action was evaluated ranges from improving the performance of the local laboratory to highlighting inadequate diagnostic tests that need to be replaced by new technologies. RESULTS: The first result approach is related to a national management of quality in laboratories. In recent years, Brazil has invested in an EQA program to aid public policy in the laboratory area. During this period, a group of haemostasis laboratory specialists were invited to manage the results and help the Ministry of Health with applying these results as a strategy to improve laboratories. Thus, in collaboration with NEQAS-BC, the University of Campinas - UNICAMP, established a Brazilian EQA program for Blood Coagulation. The second result approach is related to FVIII inhibitor assay performance evaluation, which is another type of EQA program benefit. Despite the assay being considered the gold standard to measure neutralised immunoglobulins for FVIII since 1975, over 40 years ago, the test still has a high coefficient of variation. Results from NEQAS-BC and WFH IEQAS program demonstrate the inter-laboratory variation across the United Kingdom over the last years and among emergent countries. CONCLUSION: The EQA programs have an important educational role in helping countries manage their public policy and in the international inquiry regarding the necessity of new technologies in haemostasis.

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BACKGROUND: Both the global incidence and the prevalence of sexually transmitted infections (STIs) continue to increase, affecting hundreds of millions of individuals, particularly in low-to middle-income countries. Although a definitive diagnosis is desirable to inform STI treatment, syndromic management is the most widely used strategy in resource-limited settings. With the development of point-of-care (POC) tests, it is important to discuss how laboratories will need to adapt to new training and supervisory roles in support of testing, which will largely be performed by peripheral clinical staff. OBJECTIVES: To discuss potential applications of STI POC tests, how they could improve existing STI control strategies and the role of clinical and reference laboratories in support of initiatives to improve STI management and control activities. SOURCES: Narrative literature review and expert opinion. CONTENT: The paper outlines the current status of the STI epidemic worldwide and discusses the problems associated with current approaches to control these infections, particularly in low-resource settings. The roles of clinical and reference laboratories will need to change to provide support for POC and near-patient STI testing as these technologies are introduced into clinical as well as laboratory settings. IMPLICATIONS: Laboratories will be expected to play a leading role in the introduction and implementation of POC and near-patient STI testing. They will be required to facilitate training and provide technical and supervisory support to clinical staff on the use of these technologies to augment existing STI management and surveillance programmes. In order to provide quality service, they will need to develop, introduce and maintain sustainable local quality control and external quality assurance systems. Evidence from implementation research for introduction and scale up of STI POC tests in different STI epidemic and laboratory infrastructure settings is required.

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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.

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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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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.

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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.

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