A prática da Medicina Laboratorial vem mudando em conseqüência do desenvolvimento tecnológico e regulamentações dos Sistemas de Saúde levando à implantação de Sistemas de Qualidade e monitoramento de indicadores. A aplicabilidade e os potenciais benefícios do Benchmarking como instrumento de análise da qualidade foram testados em um grupo de oito laboratórios hospitalares através do recebimento, análise e devolução aos participantes de Relatórios de Acompanhamento relativos a indicadores diversos dos anos de 2005 e 2006. O método 6 foi utilizado, quando aplicável, para avaliar a qualidade dos processos. Foram colhidos dados de indicadores de produção, produtividade, absenteísmo segurança no trabalho, recoletas e tempo para liberação de laudos. O Benchmarking é uma ferramenta útil e aplicável para a gestão de qualidade nos laboratórios clínicos, principalmente quando associado a instrumento independente de avaliação de qualidade de processos, porém é necessária a definição de mecanismos que garantam a confiabilidade dos dados primários utilizados nos programas / Laboratory Medicine practice is changing as a result of technological development and regulations pressures, letting to the implementation of quality systems and monitoring indicators. This study tested Benchmarking applicability and benefits as a tool for quality analysis in brazilian laboratory medicine services. The study was performed with eight hospital laboratories through the receipt, analysis and return to the participants of Monitoring Reports, relating to several quality indicators for the years 2005 and 2006. 6 Sigma criteria was applied as independent assessment of process quality. Data obtained shows indicators of total production, productivity, absenteeism, safety at work, redraws and turn-around-times. Benchmarking showed to be a useful and feasible tool for quality management in Brazilian clinical laboratories, particularly when associated to independent tools for evaluating the quality of laboratorial processes

Les examens de laboratoire jouent un rôle essentiel dans la pratique médicale. Ils sont utilisés à des fins diagnostique, pronostique, thérapeutique ou encore pour dépister des maladies spécifiques dans des populations présumées en bonne santé (Tietz, 1986). Quotidiennement, les laboratoires de biologie clinique réalisent des millions de tests fournissant autant de données à interpréter. Les responsables des soins de santé ont toujours été préoccupés par la qualité globale du travail réalisé dans les laboratoires. En dépit de procédures de contrôle de qualité interne rigoureuses, les résultats obtenus pour un même échantillon dans deux laboratoires peuvent occasionnellement différer de façon notoire. Il serait inacceptable cependant quun résultat dun test biologique soit considéré comme « normal » dans un laboratoire et « anormal » dans lautre. Les programmes dEvaluation Externe de la Qualité (EEQ) ont précisément comme objectif de contrôler la performance analytique des laboratoires de biologie clinique à une grande échelle et généralement par le biais dun organisme externe. Le but de lEEQ est de sassurer que les résultats des tests soient compatibles quel que soit le laboratoire qui réalise les analyses, en dautres termes de garantir la comparabilité des laboratoires et par là-même dadministrer les meilleurs soins aux patients (Libeer, 1993). Les protocoles EEQ consistent à organiser des enquêtes dans lesquelles les laboratoires participants doivent réaliser des analyses sur un même échantillon contrôle comme sil sagissait danalyses de routine. Il faut ensuite renvoyer les résultats de ces analyses au centre EEQ avec des informations détaillées sur les techniques de dosage utilisées. Les résultats sont alors soumis à une analyse statistique. En réalité, lanalyse statistique poursuit trois objectifs : (1) obtenir une estimation robuste de la concentration du constituant (moyenne) dans léchantillon contrôle et de la variabilité entre les laboratoires (écart-type), une estimation robuste étant nécessaire car les résultats EEQ contiennent souvent des valeurs aberrantes qui peuvent sérieusement affecter la moyenne et de lécart-type ; (2) évaluer la qualité des laboratoires en mettant en évidence les résultats « hors-limites » et les laboratoires « peu performants » et ce, à court et à long termes ; (3) évaluer et comparer la précision analytique des techniques/équipements utilisés par les participants (Albert, 1997). Depuis plusieurs dizaines dannées, des programmes EEQ ont été mis en place dans de nombreux pays et ils contrôlent la plupart des analyses de biologie clinique classiques comme le glucose, le cholestérol ou le calcium, ou encore les enzymes et les hormones. Ce travail a débuté lorsque lélectrophorèse de protéines fut introduite dans le panel des analyses de laboratoire soumises à lEEQ. Contrairement aux autres tests contrôlés jusqualors, lélectrophorèse de protéines fournit non pas une valeur mais cinq fractions, respectivement, lalbumine, les globulines α1, α2, β et , dont la somme fait 100% et dont linterprétation doit se faire globalement. En dautres termes, les données électrophorétiques obtenues dans lEEQ doivent être analysées par des méthodes de la statistique multivariée (Zhang et al, 2008). Ceci nécessite ladaptation à lenvironnement EEQ de méthodes multivariées existantes (telles quon les trouve dans les ouvrages de référence) ou le développement dapproches nouvelles. Dans cette thèse, nous nous sommes fixé comme but dapporter une solution théorique et pratique au problème de lanalyse et de linterprétation des résultats délectrophorèses dans le domaine de lEvaluation Externe de la Qualité. Dans lintroduction de ce travail, un bref rappel est fait des protocoles EEQ et de leur mise en pratique notamment en ayant recours à lInternet. Les méthodes univariées de statistique robuste permettant destimer la moyenne et lécart-type des résultats EEQ sont décrites et la notion de valeur « hors-limites » est définie. Ceci permet dapprécier la qualité dun laboratoire par rapport à ses pairs sur base du résultat quil a fourni. Le concept de coefficient de variation (CV) est aussi présenté comme un moyen de mesurer et de comparer la reproductibilité analytique des techniques de laboratoire. Finalement, on rappelle quelques notions relatives aux électrophorèses de protéines, leur utilité clinique et les méthodes de dosage utilisées. Les bases de données EEQ qui servent à illustrer la méthodologie statistique développée dans ce travail sont décrites en détail. Elles proviennent principalement des enquêtes de lEvaluation Externe de la Qualité réalisées entre 2004 et 2008 en France et en Belgique. La première partie de cette thèse concerne le problème de lévaluation de la performance des laboratoires pour le dosage de lélectrophorèse de protéines. La façon la plus simple consiste à appliquer les méthodes univariées classiques à chaque fraction de lélectrophorèse. Cette façon de procéder cependant ignore que les fractions doivent être interprétées globalement car elles sont corrélées. De plus, elles sont linéairement dépendantes (car leur somme est égale à 100%), ce qui conduit à une matrice de variances-covariances singulière et donc non inversible. La première approche multivariée que nous proposons vise à retirer une des cinq fractions et ainsi éviter le problème de singularité, ensuite à obtenir une estimation robuste du vecteur moyen et de la matrice de variances-covariances par la technique du déterminant de covariance minimum (MCD) publiée par Rousseuw et Van Driessen (1999). On utilise alors la distance de Mahalanobis pour identifier les profils électrophorétiques « hors-limites » et détecter les laboratoires dont la qualité est insatisfaisante (Zhang et al. 2008). Appliquée aux bases de données EEQ, cette méthode simple savère ne pas être optimale car elle donne des corrélations peu fiables et décèle trop de laboratoires « hors-limites ». Cest la raison pour laquelle, une approche nouvelle est proposée dans laquelle une transformation log-ratio (Egozcue et al. 2003) est appliquée aux profils électrophorétiques avant de les analyser statistiquement. Cette méthode transforme les cinq fractions électrophorétiques en quatre variables indépendantes et sans dimension. La technique MCD est alors appliquée pour obtenir des estimations robustes du vecteur moyen et de la matrice de dispersion. Les estimations sont utilisées pour calculer la distance de Mahalanobis et mettre en lumière les laboratoires « hors-limites ». Appliquée aux bases de données EEQ, cette seconde approche est meilleure que la première, non seulement dun point de vue théorique mais aussi pratique, en détectant un nombre plus raisonnable de laboratoires peu performants. Des méthodes de représentations graphiques des profils électrophorétiques sont aussi proposées au moyen du "MCD z-score plot" ou du "star plot" obtenu à partir de lanalyse en composantes principales (ACP) robuste. La seconde partie de la thèse sattache à lévaluation et à la comparaison de la précision analytique des techniques de dosage délectrophorèses utilisées par les laboratoires participants à lEEQ. Ceci nous a conduit à rechercher des méthodes dextension du coefficient de variation (CV) classique au cas multivariée. Les coefficients de variation multivariés publiés dans la littérature sont passés en revue, en ce compris ceux de Reyment (1960) et de Van Valen (1974, 2005). Reyment fut le premier à proposer une définition du CV multivarié et à donner une formule permettant de calculer l'erreur type de l'estimation. Van Valen suggéra une définition plus générale car applicable en toute circonstances mais qui malheureusement ne tient pas compte explicitement des corrélations entre les variables. Par ailleurs, nous avons exploité une idée de Voinov et Nikulin (1996) pour développer un CV multivarié basée sur la distance de Mahalanobis et qui est invariant par rapport à léchelle utilisée. Nous lavons appliqué aux données de lEEQ franco-belge de 2004 et avons ainsi pu classer les techniques électrophorétiques par ordre décroissant de précision analytique (Zhang et al. 2010). Malheureusement, cette approche comme celle du CV de Reyment requiert une matrice de covariance non singulière et nest donc pas applicable pour des groupes deffectif faible (n < 5) de laboratoires utilisant la même technique. Nous avons dès lors proposé une définition originale et tout à fait générale du CV multivarié, notée CVm (Albert et Zhang, 2010). Cette nouvelle formulation jouit de propriétés intéressantes; elle est simple et facile à calculer, ne requiert aucune inversion de matrice (contrairement aux autres techniques) mais uniquement le calcul de formes quadratiques. On nimpose aucune restriction sur le nombre dobservations ni sur le nombre de variables du problème. Nous avons appliqué cette méthode CVm aux bases de données EEQ délectrophorèses et nous avons pu démontrer en pratique sa grande flexibilité. Elle nous a permis de classer toutes les techniques électrophorétiques même pour des groupes de participants de petite taille (n = 2) et de mettre en évidence les plus précises, comme celle de lélectrophorèse capillaire de zone (CZE) complètement automatisée. Nous avons aussi appliqué la nouvelle méthode à des données de cytométrie de flux récoltées dans le cadre dune enquête EEQ réalisée en Belgique en 2010 ainsi quà un échantillon de données de « microarray » publié dans la littérature (Golub et al. 1999), confirmant ainsi son applicabilité à des domaines variés. Enfin, nous présentons quelques développements théoriques personnels sur le CV de Reyment afin de corriger la définition initiale, entachée à notre sens dune erreur de dimension, son estimation ainsi que la formule de lerreur type. En résumé, la méthodologie statistique développée dans ce travail propose une solution complète à lanalyse des données électrophorétiques ou de tout autre profil de tests de laboratoire récoltés dans le cadre denquêtes de lEvaluation Externe de la Qualité.

Submitted by Alexandre Sousa (alexandre.sousa@incqs.fiocruz.br) on 2014-10-21T17:32:24Z No. of bitstreams: 1 Dissertação Josefa.pdf: 1139952 bytes, checksum: a0435a26c74f1153e99f303ba64f898a (MD5) / Made available in DSpace on 2014-10-21T17:32:24Z (GMT). No. of bitstreams: 1 Dissertação Josefa.pdf: 1139952 bytes, checksum: a0435a26c74f1153e99f303ba64f898a (MD5) Previous issue date: 2012 / Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Programa de Pós-Graduação em Vigilância Sanitária. Rio de Janeiro, RJ, Brasil. / Com a descentralização das ações de Vigilância Sanitária, efetivada em fevereiro de 2005,tornou-secompetência da Vigilância Sanitária Municipal do Rio de Janeiro (Visa municipal) a inspeção e orientação de estabelecimentos de saúde, como laboratórios clínicos e postos de coleta extra-hospitalares situados no município do Rio de Janeiro. Atualmente, estes estabelecimentos devem estar cadastrados na Visa municipal e serão objeto de inspeções periódicas por equipe multidisciplinar. Embora a descentralização tenha sido fortalecedora da gestão pública na esfera municipal, veio cercada de problemas, dentre os quais a falta de roteiros de inspeção, fato que leva a questionamentos sobre a qualificação das ações do serviço da Vigilância Sanitária dos municípios e que evidencia a falta de padronização de suas atividades. O roteiro de inspeção, por ser uma lista de verificação objetiva, atua como instrumento técnico norteador das ações sanitárias, permitindo também, que os laboratórios clínicos o utilizem em auto-avaliações, tendo em vista que, deverão adequar-se na íntegra à legislação sanitária vigente englobada nos itens nele contidos. O roteiro a ser proposto neste trabalho, se baseará em legislação sanitária vigente, em normas de Boas Práticas de Laboratórios Clínicos e incluirá informações regulamentares relativas à normas de biossegurança, gerenciamento de resíduos de serviços da saúde, testes de diagnóstico, recepção, aliquotagem, armazenamento, transporte e processamento de amostras biológicas, além de itens de verificação como: organização de pessoal, estrutura física, validação de ensaios, controle da qualidade interno e externo, sistema da informação que garanta a rastreabilidade dos exames, transmissão e arquivamento de dados e gestão de qualidade total. A expectativa é que, o roteiro proposto, possa ser utilizado em futuras inspeções sanitárias em laboratórios clínicos do Município do Rio de Janeiro, pois a promoção da saúde traduz-se na manutenção da qualidade de vida, minimizando e prevenindo riscos ao meio ambiente e à saúde da população de forma individual e/ou coletiva / With the decentralization of health surveillance activities, effective in February 2005, it became the Rio de Janeiro Municipal Health Surveillance's responsibility to inspect and guide health facilities, such as clinical laboratories and collection points outside hospitals located in the municipality of Rio de Janeiro. These establishments must be registered in the Municipal Health Surveillance and will undergo periodic inspections by a multidisciplinary team. Although the decentralization has been empowering to the public administration at the municipal level, it has had its problems, among which the lack of inspection procedures, a fact that leads to questions about the qualification of the Municipal Health Surveillance actions and highlights the lack of standardization of their activities. The inspection procedure, which is an objective checklist, acts as a technical instrument that guides public health activities, allowing also that clinical laboratories use it in self-assessments considering that they must completely conform to the health surveillance) legislation in force. The procedure that is proposed in this paper is based on current health surveillance legislation, on standards of good clinical laboratory practices and include information on biosafety standards, waste management, health services, diagnostic tests, reception, fractionation, storage , transport and processing of biological samples, and on checklist items such as organization of personnel, physical structure, (testing validation), internal and external quality control, information system to ensure traceability of tests, transmission and archiving of data and total quality management. It is expected that there proposed procedure will be used in future health inspections in clinical laboratories in the city of Rio de Janeiro, because health promotion is reflected in the maintenance of quality of life, preventing and minimizing risks to the environment and health of the population, individually and / or collectively.

Submitted by Ana Lúcia Torres (bfmhuap@gmail.com) on 2018-01-08T14:08:56Z No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) DISSERTAÇAO TATIANA BURICHE.pdf: 1357055 bytes, checksum: 4e2d35ab9657b4ced51e5617a84a1770 (MD5) / Approved for entry into archive by Ana Lúcia Torres (bfmhuap@gmail.com) on 2018-01-08T14:09:05Z (GMT) No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) DISSERTAÇAO TATIANA BURICHE.pdf: 1357055 bytes, checksum: 4e2d35ab9657b4ced51e5617a84a1770 (MD5) / Made available in DSpace on 2018-01-08T14:09:05Z (GMT). No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) DISSERTAÇAO TATIANA BURICHE.pdf: 1357055 bytes, checksum: 4e2d35ab9657b4ced51e5617a84a1770 (MD5) Previous issue date: 2015 / Instituto Nacional de Cardiologia / A bioética aplica princípios éticos na tomada de decisão a fim de solucionar dilemas reais ou previstos em diversos campos, principalmente na área da saúde. O laboratório de análises clínicas é parte integrante e primordial nos modelos assistenciais de saúde em todo mundo, na execução de testes laboratoriais para fins de diagnóstico, tratamento e acompanhamento de diversas doenças. O processo de execução dos testes laboratoriais envolve tarefas complexas descritas em três fases: fase pré-analítica, fase analítica e fase pós-analítica. Essas fases envolvem falhas descritas como erros laboratoriais que podem levantar questões éticas e bioéticas. Buscamos, através de uma revisão não sistemática da literatura, com ampla pesquisa bibliográfica em bases de dados conhecidas, trabalhos e artigos científicos, a fim de identificar os erros que ocorrem no laboratório de análises clínicas caracterizando as questões éticas envolvidas. Foi elaborada uma análise bioética dos erros que ocorrem nas diferentes fases do processo laboratorial com ênfase na fase pré-analítica. Ao final da análise bioética construída, esperamos ter contribuído para aumentar a conscientização dos profissionais de laboratório para as questões éticas, aumentar a interface entre análises clínicas e a bioética, diminuir os erros laboratoriais, melhorar as tomadas de decisão e a gestão laboratorial para aumentar a satisfação e a segurança do paciente e de toda sociedade que utiliza os serviços dos laboratórios de análises clínicas / Bioethics apply ethical principles in decision making in order to solve real or anticipated dilemmas provided in various fields, especially in health care. The laboratory of clinical analysis is an integral and primordial part in health care models worldwide, in performing laboratory tests for diagnostic purposes, treatment and monitoring of various diseases. The process of execution of laboratory tests involves complex tasks described in three phases: pre-analytical phase, analytical phase and post-analytical phase. These stages involve failures described as laboratory errors that may raise ethical and bioethical issues. We search through a non-systematic literature review with ample bibliographic research on known databases, scientific papers and articles in order to identify errors that occur in clinical analysis laboratory featuring the ethical issues involved. It was elaborated a bioethical analysis of errors that occur at different stages of laboratory process with emphasis on pre-analytical phase. By the end of the constructed bioethical analysis, we hope to have contributed to raise awareness for laboratory professionals to ethical issues, increasing the interface between clinical analysis and bioethics, decreasing laboratory errors improvement of decision making in laboratory management to enhance satisfaction and patient safety and of all society that uses the services of laboratories of clinical analysis

Laboratórios clínicos são instituições sujeitas a mudanças, guiadas por fatores econômicos e tecnológicos, voltados à redução de custos e à oferta de maior efetividade e segurança ao paciente. Assim, processos automatizados aumentam sua participação no setor. A tomada de decisões laboratoriais deve satisfazer rapidamente a diferentes questões e com o mínimo de erros. O volume de dados gerados nestes sistemas é imenso e pode ser otimizado por procedimentos informáticos e estatísticos. O presente estudo tem como objetivo o desenvolvimento de estrutura de dados, colhidos a partir do servidor de interfaceamento com equipamentos analíticos. Esta estrutura tem como característica o uso de tabelas relacionais e processamento em paralelo à estrutura informática de operação. Para validar este sistema e mostrar a sua eficiência, descrevem-se dois exemplos de aplicação: estudo de interferência do tempo de resposta em relação ao resultado de hormônio paratireoideano (PTH) e avaliação de ritmicidade populacional para ácido úrico, em população do sul do Brasil. Em relação ao PTH, percebeu-se que resultados tendem a diminuir com o tempo, especialmente após 48 horas depois da coleta. Em relação à ritmicidade de ácido úrico, percebeu-se que homens e mulheres a partir de 25 anos de idade apresentam comportamento circanual (12 meses para homens e 13 meses para mulheres), com acrofase nos meses de verão. Adicionalmente, em homens com mais de 50 anos e mulheres com mais de 25 anos, ocorre outro ritmo, de 17 meses (transanual). Os dados apresentados permitem concluir que esta estrutura é útil como ferramenta complementar aos procedimentos tradicionais de controle de qualidade internos e externos, situações que estes podem não discriminar. / Clinical laboratories are subjected to a changing environment, guided by technological and marketing factors, and must be ever commited to cost reduction, better performance and patient´s safety. This drives sector to use more automated processes. Laboratory decision making must answer different questions in a right and fast way. Volume of data generated in this environment is huge, and can be better managed by using informatic and statistics concepts. This study aims to develop a data structure, using information from interfacing server to analytical equipments. This structure uses relational tables and parallel processing with laboratory information system. In order to validate this system, two examples of analysis are described: a study of interference of turnaround time on parathyroid hormone (PTH) results, and an evaluation of rhythmicity of uric acid results based on a population survey on south of Brazil. There are negative correlation between TAT and PTH, especially after 48 hours from sampling. On other side, population uric acid of men and women with more than 25 years old shows circanuallity (12 months for men and 13 months for women), with acrophase in summer months. Another transyear (17 months) rhythm was found for men with more than 50 years old and women with more than 25 years old. Presented data allow to conclude that this structure is useful and suggests that its popularization may improve use in analysis of processes as a complementary tool to traditional quality control procedures.

Introdução: A comunicação na saúde pública é uma ferramenta de promoção da saúde e acesso à informação. A melhoria da comunicação entre o laboratório clínico e os usuários constitui um direito do usuário do serviço público de saúde e também apresenta potencial para a diminuição de erros de análise provenientes da fase pré-analítica e consequente melhoria da segurança do paciente. Este trabalho teve o objetivo avaliar a adequação da linguagem escrita utilizada na comunicação entre o laboratório clínico e os usuários bem como sua influência da qualidade da fase pré-analítica do processo laboratorial. Materiais e Métodos: Foram analisadas instruções de coleta (IC) da Divisão de Laboratório Clínico (DLC) do Hospital Universitário da USP (HU/USP), de setembro de 2014 a agosto de 2016. Na primeira fase, os parâmetros de linguagem e legibilidade das IC foram avaliados pelos índices Fernández-Huerta (IFH), Flesch-Szigriszt (IFS), utilizando os programas de informática TextMeter® e INFLESZ®. Os textos de IC foram traduzidos para o espanhol e utilizados para validação dos índices IFH e IFS para a língua portuguesa. Na segunda fase, as IC foram reestruturadas e os parâmetros de linguagem e legibilidade foram analisados e comparados com as IC anteriores. O perfil sócio educacional dos usuários e uma lista dos problemas relacionados obtenção de amostras de biológicas foram obtidos na DLC. Resultados: Quanto aos parâmetros de linguagem, o número de linhas por IC, de palavras proparoxítonas e polissilábicas foi similar entre as IC anteriores e novas (p>0,05). Enquanto que o número de termos técnicos e de palavras por frase foi menor, e número de orações subordinadas e coordenadas e ordem inversas das palavras foi maior nas IC novas (p<0,05). O escore do IFH (58,4 ± 8,8) foi menor que o do IFS (62,3 ± 6,8, p=0,019) para 27 IC anteriores, mas não diferiu para as 40 IC novas (p=0,162). Os escores de IFS e IFH das IC novas em português foram similares aos das traduzidas para o espanhol, o que é indicativo de que esses índices são validos para a língua portuguesa. Os índices IFH e IFS de textos didáticos usados para avaliar o grau de escolaridade foram similares para o ensino fundamental (EF) I e II, mas foram menores para os dois últimos anos do ensino médio (EM). O número de IC com índices de legibilidade correspondentes aos textos didáticos destinados ao o 3º ano do EF II (32,7%, n=10) foi menor que o número de IC novas (52,5%, n=21), mas a diferença não foi significativa (p=0,280). Os percentuais de gênero e a cor autodeclarada foram similares entre as duas fases do estudo. Entretanto menos jovens (<34 anos), mais idosos (>50 anos) e mais usuários com EF, EM e ensino superior completo foram atendidos, na segunda fase do estudo (p<0,05). Foram identificadas mais falhas de orientação na primeira fase (n=11) que na segunda (n=22) mas sem diferença significativa (p=1,000). Conclusão: Os parâmetros de linguagem e legibilidade melhoraram após a reestruturação das novas IC. A análise de legibilidade contribui para a comunicação do laboratório clinico com os usuários e pode influenciar positivamente a qualidade da fase pré-analítica do processo laboratorial. / Introduction: Communication in public health is a tool to promote health and access to information. The improvement of communication between the clinical laboratory and the users constitutes a right of the public health service user and it is presents potential for the reduction of analytical errors from the pre-analytic phase and consequent improvement of patient safety. This work aimed to evaluate the adequacy of the written language used in the communication between the clinical laboratory and the users as well as its influence on the quality of the pre-analytical phase of the laboratory process. Materials and Methods: Collection instruction leaflet (CIL) from the Clinical Laboratory Division (DLC) of the University Hospital of USP (HU/USP) were analyzed from September 2014 to August 2016. In the first phase, the language and readability parameters of the CIL were evaluated by the Fernández-Huerta indexes (IFH), Flesch-Szigriszt (IFS), using the TextMeter® and INFLESZ® software programs. CIL texts were translated into Spanish and used for validation of the IFH and IFS indexes for Portuguese language. In the second phase, the CIL were restructured and the language and readability parameters were analyzed and compared with the previous CIL. The socioeconomic profile of the users and a list of problems related to obtaining biological samples were obtained in the DLC. Results: Regarding the language parameters, the number of lines per CIL and the proparoxytone and polysyllabic words was similar between the previous and new CIL (p> 0.05). While the number of technical terms and words per sentence were smaller, and number of subordinate and coordinated sentences and inverse order of words was higher in the new CIL (p<0.05). The IFH score (58.4 ± 8.8) was lower than the IFS score (62.3 ± 6.8, p = 0.019) for 27 previous CIL, but did not differ for the 40 new CIL (p = 0.162). The IFS and IFI scores of the new CIL in Portuguese were similar to those translated into Spanish, which is indicative of the fact that these indices are valid for the Portuguese language. The IFH and IFS indexes for didactic texts used to assess the educational level were similar for elementary education (EF) I and II, but were lower for the last two years of secondary education (MS). The number of CIL with readability indexes corresponding to the didactic texts for the 3th year of EF II (32.7%, n=10) was lower than the number of new CIL (52.5%, n=21), but the difference was not significant (p=0.280). The percentages of gender and self-reported color were similar between the two phases of the study. However, young adults people (<34 years), older people (>50 years) and more users with EF, MS and complete higher education were attended in the second phase of the study (p<0.05). More guiding failures were identified in the first phase (n=11) than in the second (n=22) but no significant difference (p=1,000). Conclusion: The language and readability parameters improved after the restructuring of the new CIL. The readability analysis contributes to the communication of the clinical laboratory with the users and can positively influence the quality of the pre-analytical phase of the laboratory process.

Various diseases, including cancer, stroke and heart attack, are associated with disruption of the vascular system. However, lack of a profound understanding of the transcription regulation during vascular development hinders the formation of effective molecular intervention strategies targeting angiogenesis. Here we describe an enhancer of Neuropilin1 (Nrp1) from the second intron of the gene that directs arterial and coronary endothelial cell-specific expression. Mice transgenic for either human or mouse sequences of the Nrp1in2 enhancers drove expression of the LacZ reporter gene specifically in the endothelial cells within the arterial compartment from early in development, while no expression was detected in veins. In addition, the hNrp1in2 enhancer directed expression to the endothelial cells in the developing coronary vasculature, with the initial expansion from around the sinus venosus at E11.5, and eventually contributed to the capillary, venous and arterial compartments of the coronary vessels but not the endocardium. This expression pattern is consistent with that reported in the Apelin-nlacZ line (Red-Horse et al., 2010), making the Nrp1 enhancer the first identified mammalian regulating enhancer of the coronary endothelial cell. Phylogenetic footprinting, and a tissue culture reporter assay suggested that this enhancer contains a 184bp minimal core region hNrp1in2peakA2 that recapitulates the expression profile of the full length enhancer. hNrp1in2peakA2 has conserved and in vitro validated recognition sites for Gata, Ets, and Fox. The validated Fox and Ets sites form a functional FOX:ETS motif, and the FOX:ETS motif is responsible for synergistic activation ofthe enhancer by FoxC2 and Etv2 in reporter assays. Mutation introduction to the functional Ets sites or compound ablation of the Gata and Fox site in hNrp1in2peakA2 result in total loss of vascular expression, in terms of both arterial and coronary expression. The Fox, Ets and Gata recognition sites may be sufficient to achieve arterial- and coronary- specific expression of the hNrp1in2peakA2.

Klinisk kemiska analyser har hög klinisk relevans. I serum/plasma kan olika parametrar kvantifieras. Dessa parametrar kan vara proteiner, enzymer, joner, metaller, lipider och kolhydrater. Med hjälp av referensintervall kan veterinärer ställa diagnos, följa behandling och sjukdomsförlopp. Parametrar detekteras med olika analysprinciper/metoder; kolorimetri, immunturbidimetri, enzymatisk metod och potentiometri. Djursjukhuset, AniCura, i Hässleholm mottagas både hundar och katter. Cirka 120 kemianalyser analyseras varje dag. AniCura har köpt in ett nytt våtkemiiinstrument, Indiko Plus, som ska ersätta Cobas C111. Med Indiko Plus tillkommer fler provpositioner, 8 nya analyser, ökad kapaciteten och underlättad användning.  Syftet med denna studie var att jämföra instrumenten och ta fram eget referensintervall som jämfördes med referensintervall framtaget av Thermo Fisher. Verifiering av det nya instrumentet genomfördes med precisionsstudie och linjäritetsstudie. Provtagning på hundar och katter utfördes av personal på AniCura. Jämförelsen gjordes med patientprover och referensintervall togs fram med hjälp av prover från friska hundar och katter. Jämförelsen visade att 9 av 13 analyser hade statistisk signifikant skillnad. Orsaken till det beror troligen på skillnaden av reagens, instrumentens ålder och tid mellan mätningar. Ett nytt referensintervall utarbetades och skiljde sig inte mycket från Thermo Fishers intervall. Vidare validering på grund av liten population rekommenderades. Precisionen för Indiko Plus blev godkänd. Linjäriteten blev icke linjär och berodde troligen på en dålig pipett och bör göras om. / Clinical chemical analyzes has high clinical relevance. In serum/plasma, different parameters can be quantified. Parameters can be proteins, enzymes, ions, metals, lipids, and carbohydrates. With reference intervals, veterinarians can set diagnosis, follow treatment and development of the disease. Parameters are detected with different analysis principles/methods; colorimetry, immunoturbidimetry, enzymatic method and potentiometry. The animal hospital, AniCura, in Hässleholm accept dogs and cats. About 120 chemical analyzes are analyzed every day. AniCura purchased a new instrument, Indiko Plus, which will replace Cobas C111. Indiko Plus provide, more sample positions, 8 new analyzes, increased capacity, and facilitated use. The purpose of this study was to compare the instruments and produce a new reference interval which was compared to the reference interval provided by Thermo Fisher. To verify Indiko Plus, a precision and linearity study were conducted. Blood sampling of dogs and cats was performed by staff at AniCura. The comparison was made with patient samples and the reference intervals were obtained using samples from healthy animals. The comparison showed 9 of 13 analyzes had a statistically significant difference. The reason for this is probably due to the difference in reagents, the age of the instruments and the time between measurements. A new reference interval was developed and did not differ much from the Thermo Fisher interval. Further validation due to low population was recommended. The precision for Indiko Plus was approved. The linearity study shows not linear trend but was likely due to a bad pipette and should be redone.

Elastinfibrer ger blodkärl och andra vävnader deras flexibilitet. Elastinfärgning är relevant när man misstänker melanom, temporalis artrit, venös invasion och efter blodkärlsoperationer. Syftet var att med hjälp av olika vävnadstyper optimera och implementera den automatiserad elastinfärgningen enligt Hart, för att ersätta den nuvarande manuella elastinfärgning enligt Verhoeff vid patologilaboratoriet på länssjukhuset Ryhov, Jönköping. Colon, njure, hud samt navelsträng färgades med den automatiska metoden enligt Hart för att hitta optimala inställningar. Vävnader från samma områden färgades med den manuella metoden enligt Verhoeff samt den automatiska metoden enligt Hart för att jämföra dem. Snitten bedömdes av en läkare så allt färgades som det skulle. Optimeringen av Harts metod resulterade i en inkubationstid på tolv minuter samt en optimal färgningsbehandling utan xylen. Resultaten av jämförelsen mellan den automatiska metoden enligt Hart och den manuella metoden enligt Verhoeff visar att den automatiska metoden enligt Hart ger bättre kontrast samt bakgrundsinfärgning. Slutsatsen blev att den automatiska metoden enligt Harts var bättre än den manuella metoden enligt Verhoeff, att i framtida studier studera möjligheten att byta ut läskningen mot till exempel ytterligare ett etanoldop samt att byta ut snitten av navelsträngen mot snitt av lever. / Elastic fibres ensure blood vessels and other tissues flexibility. Elastic staining of tissue is relevant when there is suspicion of melanoma, temporalis arteritis, venous invasion and after operations on blood vessels. The aim of the study was with the help of different tissue samples optimize and implement Hart´s elastic staining method as a substitute for Verhoeff’s at pathology lab at county hospital Ryhov, Jönköping. Colon, kidney, skin, and umbilical cord cross section got stained with Hart´s automated elastic staining method to evaluate the optimal staining procedure. Same region of the tissues was stained with Verhoeff´s manual elastic staining method and Hart´s method. All cross section were assessed and compared with the help of a pathologist doctor. Optimization of Hart´s method resulted in an incubation period of twelve minutes and optimal staining procedure without xylene. Result of comparison between Hart´s staining method and Verhoeff´s staining method showed that Hart´s staining method had a better contrast and background. Conclusions of the study was that Hart´s staining method was better than Verhoeff´s staining method, further studies could include research about a substitution of the blotting step with an extra ethanol bath as an example and liver tissue instead of the umbilical cord.

Urinblåsecancer är den sjunde vanligaste cancerformen i Sverige där blåssköljvätska utgör det huvudsakliga provmaterialet vid utredning. ThinPrep® är en vanligt förkommande metod som används inom vätskebaserad cytologi vid analys av blåssköljvätska. Fixering av provmaterialet kan försvåra diagnostiken på grund av förändrad morfologi samt artefakter.  Studiens syfte var att jämföra erhållet preparatinnehåll från blåssköljvätskor som fixerats med fixeringslösning innehållande ättiksyra med CytoLyt® solution. Studien ämnade även jämföra ThinPrep® filtren ”Non-GYN” och ”UroCyte”.  Studien inkluderade 90 patientprover av blåssköljvätska som fixerades med tillsats av ättiksyra samt CytoLyt®, varvid filtren ”Non-GYN” samt ”UroCyte” användes. Preparaten bedömdes av cytodiagnostiker samt cytopatolog utifrån kriterierna: bakgrundsmaterial, cellmängd samt färgbarhet. Resultatet visade att CytoLyt® i kombination med filtret ”Non-GYN” gav ett mer representativt preparat samt lämnade en god bakgrundsbild. Användandet av CytoLyt® resulterade i fler diagnostiska fördelar jämfört med fixering av ättiksyra, vilket även gynnar patienter. / Bladder cancer is the seventh most common form of cancer in Sweden where the main source of material for investigation are bladder washings. A common method within liquid-based cytology for analysis of bladder washings is ThinPrep®. Altered morphology as well as artifacts due to fixation can complicate funkar “the diagnostics of the sample. The aim of this study was to compare the slide content obtained from bladder washings fixed with fixative containing acetic acid with CytoLyt® solution. The study also intended to compare the ThinPrep® filters "Non-GYN" and "UroCyte". A total of 90 samples of bladder washings from patients where included. The samples where fixed with the addition of acetic acid and CytoLyt®, using the "Non-GYN" and "UroCyte" filters. A cytotechnologist and a cytopathologist assessed the preparations based on the criteria background material, cell quantity and the amount of colour change. The results showed that CytoLyt® in combination with the filter "Non-GYN" gave a more representative preparation and provided a good background image. The use of CytoLyt® resulted in more diagnostic benefits compared to fixation with acetic acid, which also benefits patients.