1,722,294 research outputs found
Unique training and compliance with ISO 15189 technical requirements in hospital clinical laboratories in Ecuador
No full textIntroducción: La acreditación ISO 15189 garantiza resultados analíticos técnicamente válidos y comparables; imprescindible en la seguridad y calidad de vida del paciente, sin embargo, no muchos laboratorios clínicos han conseguido acreditar. Objetivo: Evaluar el cumplimiento de los requisitos técnicos ISO 15189 posterior a una capacitación única en laboratorio clínico de un hospital básico Ecuador, en el año 2023. Metodología: Se realizó un estudio con enfoque empírico analítico de corte cualitativo y longitudinal, aplicándose antes y después de una capacitación única sobre la lista general de verificación de cumplimiento de acreditación del Sistema de Acreditación Ecuatoriano según la norma ISO 15189:2012. Se midió el cumplimiento de los requisitos técnicos:preanalíticos, analíticos, aseguramiento de la calidad de resultados del análisis, postanalíticos, notificación de resultados, comunicación de resultados y gestión de la información del laboratorio. Resultados: Los porcentajes de cumplimiento medidos antes y después de la capacitación única, evidenciaron incremento en todos los requisitos técnicos. El aseguramiento de la calidad mostró el menor porcentaje de cambios, del 29,41 al 41,18% ISSN: 0121-7577 e-ISSN: 2462-8425 de cumplimiento, el correspondiente a “comunicación de los resultados” experimentó el porcentaje de cambio mayor, del 33,33 al 100% de cumplimiento. Conclusiones: La capacitación demuestra ser una herramienta eficaz en el cumplimiento de requisitos que conforman la ISO 15189, no obstante, aún requieren especial atención algunos requisitos técnicos para alcanzar la acreditación, cons iderando que, para este proceso bajo la actual ISO 15189:2022, intervienen múltiples factores que van más allá de la capacitación y la implementación de sistemas de gestión de calidad.Introduction: ISO 15189 accreditation guarantees technically valid and comparable analytical results, which are essential for patient safety and quality of life. However, not many clinical laboratories have achieved accreditation. Objective: To evaluate compliance with ISO 15189 technical requirements following a single training programme in a clinical laboratory at a primary hospital in Ecuador in 2023. Methodology: A qualitative, longitudinal, empirical, analytical study was conducted before and after a single training session on the general accreditation compliance checklist of the Ecuadorian Accreditation System, in accordance with ISO 15189:2012. The following technical requirements were measured for compliance: preanalytical, analytical, quality assurance of analytical results, post-analytical, notification of results, communication of results and management of laboratory information. Results: Compliance percentages measured before and after the training session increased for all technical requirements. Quality assurance showed the lowest percentage change in compliance (from 29.41% to 41.18%), while communication of results showed the highest (from 33.33% to 100%). Conclusions: Training has proven to be an effective tool in meeting the ISO 15189 requirements. However, special attention is still required for some technical requirements to achieve accreditation. This is because multiple factors beyond training and the implementation of quality management systems intervene in the current ISO 15189:2022 process
Benefits of accreditation under ISO 15189 standard for clinical laboratories
No full textEl laboratorio clínico es un proceso de gran importancia para realizar un adecuado diagnóstico y tratamiento en los pacientes. Por tal motivo, es necesario lograr resultados confiables y de calidad con el fin de garantizar la prestación de servicios de salud que cumplan con las necesidades y expectativas de los clientes. En aras de fortalecer la calidad de los servicios de salud, una de las mejores opciones es la implementación de la acreditación bajo los requisitos de la norma ISO 15189:2014. En el presente artículo se realizó una investigación mediante la revisión de fuentes bibliográficas como bases de datos, revisión de modelos de incentivos de acreditación, páginas del sector público y bases de datos nacionales. Se identifican los principales beneficios que obtienen los laboratorios clínicos que se acrediten bajo la norma ISO 15189:2014, la situación actual de la acreditación en Colombia y los incentivos que pueden motivar al sector para aumentar el número de laboratorios clínicos acreditados en Colombia.The clinical laboratory is a high importance process to carry out an appropriate diagnostic and treatment for patients. Thus, it is needed to achieve reliable results with high quality, aimed to ensure a service delivery that fulfills customers’ necessities and expectations. Therefore, regarding strengthening health services, one of the best options is to apply the accreditation under the requirements of the standard ISO 15189:2014. This paper shows research developed through review of different bibliographic sources such as databases and incentive accreditation models, public sector webpages and national databases were considered. Hence, it has been possible to identify the main benefits that obtain the clinical laboratories accredited under the standard ISO 15189:2014, as well as the current Colombian accreditation circumstances, and the incentives which can encourage the public sector to increase the number of accredited clinical laboratories in Colombia.Especializació
Symposium NGS 2016 - Accreditation of NGS within ISO 15189
No full textAccreditation of NGS within ISO 15189</p
Importancia de la aplicación de las normas ISO 15189 en los laboratorios clínicos
Get PDF Legal precept 15189 of the International Organization for Standardization is the one that is used in clinical laboratories to obtain the accreditation of the laboratories, since this accreditation is what supports the reliability of the activities carried out in the laboratory. The objective of this research is to raise awareness of the importance of the application of ISO 15189 standards, thus demonstrating comprehensive quality in clinical laboratories.
Specific objectives: Evaluate the degree of adoption and compliance with ISO 15189 standards in clinical laboratories. Investigate the impact of the application of ISO 15189 standards on the quality of analytical results issued by clinical laboratories, focusing on the precision, accuracy and reproducibility of the analyses. Analyze the influence of ISO 15189 standards on the continuous improvement of operational processes in clinical laboratories, examining efficiency, resource management and satisfaction of internal and external users.
The methods used in this research are based on various bibliographic documents in which extremely relevant information for the research was found, some of them are: articles, research and journals, all approved by the scientific community.
The result is that the comprehensive quality of clinical laboratories is based on the application of the ISO 15189 standard, the importance of the adoption of integrated management systems, continuous training of personnel, implementation of information management technologies and audits. periodically guarantees compliance with this standard.
El precepto legal 15189 de la Organización Internacional de Normalización es aquel que se emplea en los laboratorios clínicos para así obtener la acreditación de los laboratorios, ya que esta acreditación es la que respalda la confiabilidad de las actividades que se realizan en el laboratorio. El objetivo de esta investigación es dar a conocer la importancia de la aplicación de las normas ISO 15189, demostrando así la calidad integral en los laboratorios clínicos.
Objetivos específicos: Evaluar el grado de adopción y cumplimiento de las normas ISO 15189 en laboratorios clínicos. Investigar el impacto de la aplicación de las normas ISO 15189 en la calidad de los resultados analíticos emitidos por los laboratorios clínicos, centrándose en la precisión, exactitud y reproducibilidad de los análisis. Analizar la influencia de las normas ISO 15189 en la mejora continua de los procesos operativos de los laboratorios clínicos, examinando la eficiencia, la gestión de recursos y la satisfacción de los usuarios internos y externos.
Los métodos utilizados en esta investigación se basan en diversos documentos bibliográficos en los que se encontró información sumamente relevante para la investigación, algunos de ellos son: artículos, investigaciones y revistas todas aprobadas por la comunidad científica.
Se obtiene como resultado que la calidad de integral de los laboratorios clínicos se basa en la aplicación de la norma ISO 15189, la importancia de la adopción de sistemas de gestión integrada, capacitación continua del personal, implementación de tecnologías de gestión de la información y auditorías periódicas garantiza el cumplimiento de esta norma
Normas ISO 15189 y la calidad integral en los laboratorios clínicos.
Get PDFStandard 15189 of the International Organization for Standardization is the one used by clinical laboratories to obtain the accreditation that supports the performance of their activities, which contains the functional technical guidelines in relation to correct performance, these group the necessary requirements in the analysis and interpretation of biological samples from human origins. For this reason, the main objective of the investigation is directed to demonstrate the application of the ISO 15189 standards for the integral quality of the clinical laboratory, the specific objectives for their part are structured as follows: Determine the importance of the application of the ISO standard 15189 in the pre-analytical, analytical and post-analytical phases of the clinical laboratory; Establish the criteria that support comprehensive quality in clinical laboratories according to ISO 15189; Identify errors due to the lack of comprehensive quality in clinical laboratories. The applied methodology corresponds to a descriptive documentary design of an explanatory level, taking articles and research published in scientific databases and indexed journals in English and Spanish as a source of information. In this context, having as a result that integral quality is a mechanism which supports the functionality and applicability of the ISO 15189 standard, reducing the lack of quality in clinical laboratories. It is concluded that the application of the ISO 15189 standard is necessary for the proper functioning of the laboratory in an effective and efficient manner, determining its integral quality parameters based on it.La norma 15189 de la Organización Internacional de Normalización es aquella empleada por los laboratorios clínicos para conseguir la acreditación que respalde la realización de sus actividades, donde constan los lineamientos técnicos funcionales en relación con el correcto desempeño, estas agrupan los requisititos necesarios en el análisis e interpretación de muestras biológicas procedentes de orígenes humanos. Por ello el objetivo principal de la investigación se direcciona a demostrar la aplicación de las normas ISO 15189 para la calidad integral del laboratorio clínico, los objetivos específicos por su parte se estructuran de la siguiente manera: Determinar la importancia de la aplicación de la norma ISO 15189 en las fases preanalítica, analítica y post-analítica del laboratorio clínico; Establecer los criterios que sustentan a la calidad integral en los laboratorios clínicos según la normativa ISO 15189; Identificar errores por la falta de calidad integral en los laboratorios clínicos. La metodología aplicada corresponde a un diseño documental de descriptivo de nivel explicativo tomando como fuente de información a artículos e investigaciones publicados en bases de datos científicas y revistas indexadas en inglés y español. En este contexto, teniendo como resultado que la calidad integral es un mecanismo el cual fundamenta la funcionalidad y aplicabilidad de la norma ISO 15189, disminuyendo la falta de calidad en los laboratorios clínicos. Se concluye que la aplicación de la norma ISO 15189 es necesaria para el correcto funcionamiento del laboratorio de manera efectiva y eficiente determinando sus parámetros de la calidad integral basados en la misma
Going Beyond Counting First Authors in Author Co-citation Analysis
Get PDFThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Investigating the suitability of ISO 15189:2007 for medical research
Get PDFM.Tech. (Operations Management)Accreditation allows people to make an informed decision when selecting a laboratory. It demonstrates competence, impartiality and capability. Most South African medical laboratories are accredited or aim to be accredited to the ISO 15189 standard. Medical research laboratories are using ISO 15189 with some resistance. Nonmedical research laboratories utilise ISO 17025, which has specifically been designed for testing and calibration laboratories. The purpose of this study was to assess whether ISO 15189 is suitable for the function performed by medical research laboratories. A literature review was used to determine the current quality process in medical laboratories. A qualitative research approach was followed with one-on-one semi-structured interviews with senior laboratory personnel (N=20) and a focus group (N=1) conducted with a group of senior laboratory personnel to assess the suitability of standards in medical laboratories in South Africa and address the future needs of these laboratories with regard to quality management and accreditation. The purposeful sample included interviews with personnel who were sourced from 20 diverse South African medical laboratories that perform diagnostic, surveillance and research testing. The questions were divided into three sections. The first section dealt with the interviewee’s demographics. The second section focused on the activities of the laboratories regarding accreditation and quality management systems. The third section dealt with the opinions of managers regarding the benefits, strengths and weaknesses of being accredited to a standard, and the necessity for this. The results were evaluated with a group of specialists
Requirements for quality and competence according to EN ISO 15189 for medical virological laboratory diagnostics. A field report
No full textIn der internationalen Norm DIN EN ISO 15189 (kurz ISO 15189) sind für medizinische Laboratorien besondere Anforderungen an die Qualität und Kompetenz festgelegt. Die ISO 15189 gilt für alle medizinischen Laboratorien. Sie wurde für den Bereich der Virologie durch eine gemeinsame Arbeitsgruppe der Gesellschaft für Virologie (GfV) und der Deutschen Vereinigung zur Bekämpfung der Viruskrankheiten (DVV) in Form von fachspezifischen Checklisten konkretisiert.
Viele medizinische Laboratorien lassen sich im Rahmen einer Akkreditierung bestätigen, dass sie die Anforderungen der ISO 15189 erfüllen. Wesentlicher Bestandteil der Akkreditierung ist eine Begutachtung in den Laboratorien. Die Begutachtungen in der Virologie werden von Experten durchgeführt, die von der GfV benannt werden.
Gründe der Laboratorien für eine Akkreditierung können sehr unterschiedlich sein. Sie reichen von der Verbesserung der internen Abläufe und Ermittlung sicherer/richtiger Untersuchungsergebnisse bis zu einer besseren Positionierung am Markt.
Der Artikel stellt die Anforderungen und Probleme virusdiagnostisch tätiger Laboratorien, basierend auf der ISO 15189, als Erfahrungsbericht vor. Dabei wird auf die Infektionsserologie, die molekularbiologische Diagnostik und die Virusisolierung auf Zellkulturen eingegangen.The International Standard EN ISO 15189 (in short ISO 15189) provides requirements for competence and quality that apply to medical laboratories. The ISO 15189 applies to all medical laboratories. For virology this standard has been established by a joint working group of the German Society of Virology (GfV) and the German Association Against Virus Diseases (DVV) in the form of check lists. Numerous medical laboratories get the fulfilment of the requirements of ISO 15189 confirmed by accreditation. A substantial part of the accreditation process is the onsite assessment in the laboratories. In the case of virology, this assessment is performed by experts appointed by the GfV.
Laboratories may have very different reasons for accreditation. These range from the improvement of the internal processes and determination of reliable examination results to better positioning at the market.
The article presented here is a field report outlining the requirements and problems for laboratories in medical virology – based on ISO 15189 – thereby addressing the issues of serology, molecular-biological diagnostics and virus isolation on cell cultures
Variations on the Author
Get PDF“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
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