ABSTRACT
A pesquisa em que se baseia este artigo apresenta uma discussão de fronteira entre as temáticas comunicação pública e qualidade da informação. Assumiu como objeto de estudo as edições do boletim epidemiológico com dados da transmissão do novo coronavírus, publicadas em um dos canais oficiais digitais da Prefeitura Municipal de Frutal, cidade localizada no Triângulo Mineiro, estado de Minas Gerais. Com os objetivos de analisar não só o conteúdo dos boletins epidemiológicos, para discutir as práticas de comunicação pública empregadas no período estudado, mas também os atributos de qualidade da informação presentes no produto informacional, foi feito um monitoramento das postagens realizadas por ela, no Facebook, de abril de 2020 a abril de 2022.
Subject(s)
Humans , Periodicals as Topic , Information Management , COVID-19 , Quality Control , Communication , Qualitative Research , Quality Improvement , Health CommunicationABSTRACT
Equipos são dispositivos médicos que, ao apresentarem desvios de qualidade, podem ocasionar agravos a elevado número de pessoas. Este estudo objetivou avaliar o perfil das notificações de queixas técnicas realizadas no Sistema Notivisa, desenvolvido pela Agência Nacional de Vigilância Sanitária, para discussão sobre o seu impacto na segurança do paciente. Por meio de metodologia quantitativa foram avaliados equipos comercializados no período de 2016 a 2017, cinco anos após a instituição da certificação metrológica compulsória. As principais queixas técnicas se referiram a problemas na integridade (82,70%): defeito mecânico, vazamentos, problemas no corta-fluxo, oclusão de fluido e descolamento, problemas na embalagem ou rotulagem (8,54%) e presença de corpo estranho e sujidades (7,97%). Tais falhas podem interferir nos procedimentos diagnósticos e/ou de tratamento, como a administração de medicamentos quimioterápicos, de antibióticos e também a realização de transfusões. Assim, a tecnovigilância é fundamental para a segurança sanitária no mercado a partir da identificação dos riscos e da possibilidade de mitigá-los, promovendo a segurança do paciente.
Infusion sets are medical devices that, when presenting quality deviations, can cause harm to a large number of people. This study aimed to evaluate the profile of technical complaint notifications made on the Notivisa System, developed by Anvisa Agência Nacional de Vigilância Sanitária (National Agency for Health Surveillance), so as to discuss its impact on patient safety. By means of quantitative methodology, devices sold from 2016 to 2017 was evaluated, five years after the establishment of compulsory metrological certification. The main technical complaints referred to integrity problems (82.70%): mechanical defect, leaks, flow shutdown issues, fluid obstruction and detachment, packaging or labeling problems (8.54%) and presence of foreign bodies and dirt (7.97%). Such failures can interfere with diagnostic and/or treatment procedures such as the administration of chemotherapy drugs, antibiotics and also the transfusion process. Thus, the technovigilance is essential for health safety in the market, based on the identification of risks and the possibility of mitigating them, thus promoting the patient safety.
Los equipos son aparatos médicos quepueden resultar en daños a un gran número de personas por si acaso presentan desviaciones de calidad. El objetivo de esta investigación ha sido evaluar el perfil de notificacio-nes de quejas técnicasregistradas en el Sistema Notivisa, desarrollado por Anvisa Agência Nacional de Vigilância Sanitária (Agencia Nacional de Vigilancia Sanitaria) con miras a la discusión de su impacto en la seguridad del paciente. Valiéndose de la metodología cuantitativa se evaluaron los equipos comercializadosdesde 2016 hasta 2017, que coincide con los cinco años tras la institución de la certificación metrológica obligatoria. Las principales quejas técnicas (82,70%) se refirieron a problemas de integridad: defecto me-cánico, fugas, problemas en el corta flujo oclusión y despegue de fluidos, dificultades en el embalaje o en la rotulación (8,54%) además de la presencia de cuerpo extraño y suciedades (7,97%). Dichos desperfectospueden obstaculizar los procedimientos de diagnóstico y/o de tratamiento, como la administración de fármacos quimioterapéuticos, antibióticos y también la realización de trasfusiones. De ahí que la tecnovi-gilancia sea fundamental para la vigilancia sanitaria en el mercado a partir de la identificación de riesgos sumada a la posibilidad de paliarlos, fomentando la seguridad del paciente.
Subject(s)
Male , Total Quality Management , Equipment and Supplies , Quality Control , Risk Management , Health Surveillance , Hospital Care , Patient Care , Health FacilitiesABSTRACT
Responsabilização (accountability) em comunicação e editoração científica é um importante tema em ética e integridade em pesquisa, e um dos grandes desafios atuais da ciência. Este artigo apresenta um estudo descritivo sobre a responsabilização e os seus atores na comunicação científica (autores, revisores, editores), partindo da questão da responsabilização desses atores e das más condutas científicas vista por editores de revista SciELO do Brasil e de países da América Latina. Apresenta resultados a partir da visão dos editores em que os autores são responsáveis, e, parcialmente, os revisores e os próprios editores
Accountability in scientific communication and publishing is an important topic in ethics and research integrity, and one of the great challenges of science today. This article presents a descriptive study on accountability and its actors in scientific communication (authors, reviewers, editors), starting from the issue of accountability of these actors and from the scientific misconducts viewed by SciELO journals editors in Brazil and Latin America. Based on the editors' view, it stands that the authors are responsible, and the reviewers and the editors are partially responsible
La responsabilidad (accountability) en la comunicación y publicación científica es un tema importante en la ética y la integridad en la investigación, y uno de los grandes desafíos de la ciencia actual. Este artículo presenta un estudio descriptivo sobre la responsabilidad y sus actores en la comunicación científica (autores, revisores, editores), a partir de la cuestión de responsabilidad de estos actores y de las malas conductas científicas vista por los editores de revista SciELO en Brasil y en países de América Latina. Presenta resultados en la visión de los editores de que los autores son responsables, y los revisores y los propios editores son parcialmente responsables.
Subject(s)
Humans , Publishing , Scientific Misconduct , Duty to Warn , Communication , Ethics, Research , Quality Control , Science , Periodical , Editorial PoliciesABSTRACT
Resumen Se identifican y analizan las principales problemáticas de las publicaciones científicas, estudiando los diferentes componentes del ecosistema en el que se producen, con énfasis en la realidad latinoamericana. A través del relevamiento y análisis bibliográfico, se identifican como problemáticas la forma de acceso, los criterios de calidad y evaluación utilizados, la visibilidad, la barrera de la lengua y la brecha de género. Al mismo tiempo que se conceptualizan, se establecen vínculos entre dichos componentes lo que agrega complejidad al fenómeno y permite visualizar los modelos de comunicación científica vigentes. Dicha identificación pretende abrir espacios para la proposición de propuestas a futuro, que aporten en el sentido de brindar mayor acceso y reducir las inequidades observadas. Al mismo tiempo, la exposición del tema permite a los investigadores contar con mayores elementos a la hora de pensar y hacer visibles sus publicaciones. Desde la perspectiva latinoamericana se observaron ciertas particularidades en relación al crecimiento del movimiento de acceso abierto, sostenido muchas veces por instituciones y editoriales que pugnan por mejorar las formas de circulación, distribución, visibilidad y acceso, aunque cuenten con recursos limitados. Finalmente, se insiste en la necesidad de defender y potenciar el modelo de información científica basado en acceso abierto, como uno de los objetivos a promover para hacer frente a la privatización y comercialización del conocimiento producido por las comunidades científicas.
Abstract Identification and analysis of the main problems of scientific researches by studying the different components of the ecosystems they are produced, emphasising in Latin America's reality. Through surveying and bibliographical analysis, problems such as access ways, quality and evaluation criteria, visibility, language barriers and gender gap are identified. As they are defined, these concepts are also threaded, adding complexity to the matter and allowing to visualize scientific media current's state. Its purpose is to open the field for future proposals regarding greater access and narrowing the inequality gap. Besides, the topic's exposure provides researchers with a wider group of elements when thinking about their work and how to publish it. From a latin american perspective, there is observance of certain aspects linked to the growth of the open access movement, which is mainly sustained by insitutions and publishers that try to improve ways of distribution, circulation, visibilty and access, despite limited resources. Finally, the importance of defending and boosting the scientific information access model based on open access is strongly outlined, as one of the main policies that will allow to keep corporate interests apart from the knowledge scientific communities produce.
Subject(s)
Quality Control , Journal Article , Impact Factor , Health Research Evaluation , Scientific Publication Indicators , Gender EquityABSTRACT
Quality control of ahomeopathic mother tincture begins with the analysis of the raw material. Once the product is obtained, some organoleptic characteristics and Physicochemical properties such as appearance, colour, odour, density, dry residue, alcohol content,and chemicalmarker are evaluated. In Brazil, mother tinctures from different suppliers may have high variability in terms of the specifications described in the homeopathic pharmacopoeia. Objective: The aim of the present study was to compare mother tinctures' quality control from different pharmaceutical suppliers based on Brazilian Homeopathic Pharmacopoeia 3rd edition. Methods: Five mother tinctures were selected according to the high number of requests in the pharmacies, also its monographs are in the Brazilian Homeopathic Pharmacopoeia (FHB) 3rd edition. The report of analysis of the product was provided by three homeopathic pharmacies from the city of Rio de Janeiro. The information in the reports wasevaluated and compared to its monograph. Results and discussion: In this study, it was found that the number of laboratories that provide homeopathic pharmaceutical ingredients is rather low. In addition, in some reports, a number of identification tests werenot described properly when compared to the monograph. Besides that, some information diverges from the pharmacopoeia, for example, absence of dry residue testing, replacement of the part of the plant used to prepare the mother tincture,and results that do not meet pharmacopoeia specifications. As can be seen, the quality and effectiveness of homeopathic medicines prepared from these tinctures may be compromised. Conclusion:In order to guarantee consumer protection and the quality and effectiveness of medicines, governments and regulatory agencies should requirea greater commitment from suppliers in the production of homeopathic inputs.
Subject(s)
Quality Control , Mother TinctureABSTRACT
El control interno de calidad en el laboratorio clínico es una actividad especializada que monitoriza la calidad de los procesos y resultados, a la vez que permite aceptar o rechazar las corridas analíticas de las diferentes determinaciones. A tales efectos, se presentan los elementos de una guía práctica incluida en un software, diseñada con el objetivo de perfeccionar el control interno de la calidad en dichos laboratorios, donde se definen los principios y conceptos claves del tema, los procedimientos y su secuencia, los requisitos de calidad, las reglas de control, los cálculos estadísticos, la interpretación de los resultados, así como algunos de los indicadores novedosos y necesarios para asegurar la calidad.
The internal control of quality in the clinical laboratory is a specialized activity that monitors the quality of the processes and results at the same time that it allows to accept or to reject the analytic runs on the different determinations. To such effects, the elements of a practical guide included in a software are presented, designed with the objective of perfecting the internal control of the quality in these laboratories, where the principles and key concepts of the topic, procedures and their sequence, requirements of quality, control rules, statistical calculations, the interpretation of the results are defined, as well as some of the novel and necessary indicators to assure the quality.
Subject(s)
Total Quality Management , Laboratories, Clinical , Quality ControlABSTRACT
Introducción: a pesar de que la técnica de papanicolaou es el método más eficaz para la prevención y detección del cáncer cervicouterino, la precisión de esta herramienta sigue siendo controversial; debido a esto, existen esfuerzos médicos y científicos para mejorar la calidad del procedimiento. Objetivo: comparar la calidad en la toma de muestra entre la técnica convencional y la modificada. Material y métodos: estudio observacional descriptivo y comparativo en 150 muestras de citología cervical (75 muestras técnica convencional y 75 en técnica modificada) en mujeres de 25 a 64 años. Se analizaron variables emográficas, características del cérvix y calidad de la muestra. Se realizó estadística descriptiva y medidas de asociación. Estudio con riesgo mayor que el mínimo. Todas las participantes firmaron consentimiento informado. Resultados: la calidad de la muestra fue satisfactoria en el 92% para la técnica convencional frente al 89.3% para la técnica modificada. La causa principal de muestras insatisfactorias fue la celularidad insuficiente, la cual se presentó en el 6.7% de las muestras con técnica convencional frente al 12% de la técnica modificada, sin diferencia significativa entre ambas técnicas p = 0.575 (1.37; 0.45-4.1), hallazgos que rechazan la hipótesis de trabajo. Conclusiones: no hubo diferencia significativa al utilizar ambas pruebas, las muestras con calidad satisfactoria fueron similares entre ambas técnicas.
Background: Despite the fact that the Papanicolaou technique is the most effective method of prevention and detection of cervical cancer, the precision of this tool remains controversial; Because of this, there are medical and scientific efforts to improve the quality of the procedure. Objective: Compare the quality of sampling between the conventional and modified technique. Material and methods: Descriptive and comparative observational study in 150 cervical cytology samples (75 conventional technique samples and 75 in modified technique) in women aged 25 to 64 years. Demographic variables, characteristics of the cervix and quality of the sample were analyzed. Descriptive statistics and association measures were performed. Study with risk greater than the minimum. All participants signed an informed consent. Results: The quality of the sample was satisfactory in 92.0% for the conventional technique vs 89.3% for the modified technique. The main cause of unsatisfactory samples was insufficient cellularity 6.7% in conventional technique vs 12% of the modified technique, with no significant difference between both techniques p = 0.575 (1.37; 0.45-4.1), findings that reject the working hypothesis. Conclusions: There was no significant difference when using both tests, the samples with satisfactory quality were similar between both techniques.
Subject(s)
Humans , Female , Adult , Middle Aged , Uterine Cervical Neoplasms/diagnosis , Papanicolaou Test/methods , Quality Control , Prospective Studies , Risk Assessment , Saline SolutionABSTRACT
O objetivo deste trabalho foi analisar e correlacionar os resultados de qualidade do leite cru refrigerado de dez propriedades rurais de Viçosa (MG) obtidos por métodos de referências do Ministério da Agricultura, Pecuária e Abastecimento e por espectrofotômetros de luz infravermelha em três laboratórios (A, B e C) credenciados pelo mesmo órgão de fiscalização. As amostras de leite foram analisadas quanto à contagem bacteriana, contagem de células somáticas (CCS) e teores de gordura, proteína e extrato seco desengordurado (ESD). Não houve discordância de amostras de leite quanto aos teores de proteína e gordura. Porcentagens diferentes de discordância foram observadas entre os resultados dos laboratórios e método de referência quanto à CCS, contagem bacteriana e teores de ESD. Os teores médios de proteína dos laboratórios A e B e os teores médios de ESD de todos laboratórios não foram estatisticamente iguais (p<0,05) aos teores obtidos pelo método de referência. Os teores de gordura obtidos no laboratório B não tiveram correlação estatística (p>0,05) com os teores obtidos pelo método de referência. Observou-se que as CCS e contagens bacterianas médias de todos os laboratórios foram estatisticamente iguais (p>0,05) e correlacionadas (p<0,05) às contagens médias obtidas pelos métodos de referência. Conclui-se que os teores de proteína em dois laboratórios e ESD em todos os laboratórios não são equivalentes com os métodos de referência do MAPA. É importante que os laboratórios revejam a calibração dos seus equipamentos quanto à quantificação dos teores de sólidos do leite.
The objective of this study was to analyze and to correlate the results of refrigerated raw milk quality in ten farms of Viçosa (MG). The milk was analyzed by the Ministério da Agricultura, Pecuária e Abastecimento standard methods and by infrared spectrophotometers in three laboratories (A, B and C) accredited by the same institution. The milk samples were analyzed for bacterial counts, somatic cell count (SCC) and fat, protein and solids not fat (SNF) tenors. There were no disagreement milk samples as the protein and fat tenors. Different percentages of disagreement were observed between the results of laboratory and standard method as the SCC, bacterial count and SNF tenor. The protein mean tenor of A and B laboratories and the SNF mean tenor of all laboratories were not statistically equal (p<0.05) the tenors obtained by standard method. The fat tenors obtained in B laboratory were not statistically correlated (p>0.05) with tenors obtained by the standard method. It was observed that the means of SCC and bacterial counts of all laboratories were statistically the same (p>0.05) and correlated (p<0.05) to the means counts obtained by standard methods. It is concluded that the protein tenors in two laboratories and SNF in all laboratories are not equivalent with the reference methods of MAPA. It is important that laboratories review the calibration of the equipment on the quantification of milk solids tenors.
Subject(s)
Quality Control , Spectrophotometers , Food Quality Standards , Milk/standards , Bacterial Load/standards , Raw Foods/analysisABSTRACT
Esse estudo consistiu em analisar a confiabilidade e a eficácia dos métodos do controle interno da qualidade das bioquímicas em um laboratório privado, a partir da criação dos próprios valores de referência, utilizando como ferramentas o gráfico de Levey Jennings e regras de Westgard. Métodos: Foram estabelecidos nesse estudo os próprios valores de referência para cada analito, dispostos os valores de qualidade diários nos gráficos e realizadas as interpretações para validação do teste. Resultados: Através da implementação dos valores próprios de referência e um controle de qualidade mais rígido, foi possível identificar uma melhor estabilidade dos analitos, melhor percepção dos erros aleatórios, sistemáticos e tendenciosos, obtendo informações mais confiáveis e efetivas perante os controles. Conclusão: Os resultados desta análise indicam uma maior estabilidade e uma menor variabilidade dentro dos valores de referência criados, resultando em exames mais precisos e seguros.
Objective: This study consisted of analyzing the reliability and effectiveness of the methods of internal quality control of biochemists in a private laboratory, from the creation os their own reference values, using the Levey-Jennings chart and Westgard rules as tools. Methods: In this study, the reference values for each analyte were created, the daily quality values were displayed on the graphs, and the interpretations were carried out to validate the test. Results: Through the implementation of proper reference values and stricter quality control, it was possible to identify better stability of the analytes, better perception os random, systematic and biased errors, obtaining more reliable and effective information from the controls. Conclusion: The results of this analysis indicate greater stability and less variability within the created reference values, resulting in more accurate examinations.
Subject(s)
Quality Control , Reference Values , Clinical Decision RulesABSTRACT
Introducción: Para el inicio de las operaciones en el servicio de medicina nuclear del Instituto de Hematología e Inmunología, se realizó el análisis de los riesgos radiológicos. Objetivos: Determinar la contribución individual de las etapas del proceso y de los elementos de control en el riesgo radiológico. Métodos: Se desarrolló el modelo del proceso a partir del método de la matriz de riesgo. Las medidas que se adicionaron estuvieron dirigidas a eliminar las secuencias accidentales con riesgo de nivel medio y consecuencias altas para los pacientes. Se determinaron los elementos de control más importantes por su participación porcentual e incidencia en el cambio del nivel de riesgo al ser eliminados. Resultados: Las etapas más contribuyentes al riesgo fueron por orden de importancia; la preparación de radiofármacos, la adquisición de las imágenes y la administración. Se destacan las medidas siguientes: carga de trabajo moderada, capacitaciones al oficial de protección radiológica y al que realiza las administraciones, el procedimiento de contrastar los datos de la dosis que será administrada al paciente con lo establecido en la prescripción del estudio, las pruebas de control de calidad de radiofármacos, el análisis de los resultados de la dosimetría realizada periódicamente a los trabajadores y las auditorías externas e internas con equipamiento diferente. Conclusiones: Se incluyeron todas las medidas identificadas en la obtención del riesgo residual y en el análisis de sensibilidad en el Plan de mejora de la seguridad y calidad, como garantía de la seguridad radiológica de las operaciones(AU)
Introduction: For the start of operations in the nuclear medicine service of the Institute of Hematology and Immunology, the analysis of radiological risks carried out. Objectives: To determine the individual contribution of the stages of the process and of the control elements in the radiological risk. Methods: The developed process model was from the risk matrix method. The added measures were at eliminating accidental sequences with medium risk and high consequences for the patients. The most important control elements were by their percentage participation and incidence in the change in the level of risk when they eliminated. Results: The stages most contributing to the risk were, in order of importance, the preparation of the radiopharmaceuticals, the acquisition of the images and the administration. Highlighted measures are the following: a moderate workload, the training for the radiation protection officer and the one who performs the administrations and the procedure of contrasting the data of the dose that will administer to the patient against what is in the study prescription. Besides are the tests quality control of radiopharmaceuticals, the analysis of the results of the dosimetry performed on the workers periodically and the external and internal audits with different equipment. Conclusions: All the measures identified in obtaining the residual risk and in the sensitivity analysis, were included in the Safety and Quality Improvement Plan, as a guarantee of the radiological safety of the operations(AU)
Subject(s)
Humans , Quality Control , Radiation Protection , Total Quality Management , Allergy and Immunology , Nuclear MedicineABSTRACT
O objetivodo presente estudo foiavaliar a percepção de acadêmicos de Odontologia quanto àqualidade dos serviços prestados no âmbito da clínicade uma universidade privada do Nordeste brasileiro.Trata-se deuma pesquisa quantitativa, de caráter avaliativo e corte transversal realizada com 201 estudantesmatriculadosdo 4º ao 10º semestre de graduação,que prestaram atendimentoclínicoaospacientes.Realizou-se a coleta de dados no período de abril a setembro de 2019, por meio da aplicação de umquestionário contendo 35 questões objetivas, dividido emtrês blocos relacionados a: infraestrutura; qualidade do atendimento clínico; eações gerenciais. Dos 201 participantes, em quesitos relacionados àinfraestrutura, 187 (93%) apontaram adequadas condiçõesde uso, 198 (98,5%)boascondições de limpeza e 188 (93,5%) afirmaram que as instalações da clínicagarantem condições de acessibilidadee mobilidade. Em relação à qualidadedo atendimento, 102 (50,7%) participantes apontaram que houve orientação ao paciente após o tratamento, porém 200 (99,5%) afirmaram que é realizado o encaminhamento entre as clínicas quando necessário para completar otratamento.Para os aspectos gerenciais, 95 (47,3%)indicaramque são disponibilizadoscanais de comunicação aos pacientes, e 156 (77,6%)afirmaramque existe uma relação democrática e cooperativa com a coordenação. Os aspectos da qualidade relacionados ao âmbito da clínica escola foram considerados satisfatórios, contudo,existe anecessidade de uma análise mais aprofundada no processo de comunicação e monitoramento das ações para contínua melhoria da qualidade (AU).
This study aimed to evaluate the perception of academics regarding the quality of services provided within the clinical school of a Dentistry Course at a private university in Northeastern Brazil. Quantitative, evaluative and cross-sectional research carried out with students from the 4th to the 10th semester of graduation. Data collection was carried out from April to September 2019 with 201 participants who provided care to patients at the clinics. A questionnaire adapted from the Quality Assessment Instrument used in public health services was used. The instrument contained three blocks of aspects to be assessed: infrastructure; clinical care and satisfaction; managerial actions. Most participants indicated satisfactory conditions, highlighting the structural building categories (89.6%), cleanliness (98.5%) and accessibility (93.5%). As for the work process, there were positive responses above 80%, but only 50.7% indicated that there was guidance to the patient after assistance. For managerial aspects, 52.7% indicated that communication channels are available to patients and 77.6% stated that there is a democratic and cooperative relationship with the coordination. According to the perception of the interviewees, the aspects of quality related to infrastructure, work process and management actions of the services provided within the clinic were considered satisfactory, with identification of aspects that signal the need for a more in-depth analysis in the process of communication and monitoring of actions for continuous quality improvement (AU).
Subject(s)
Humans , Male , Female , Quality Control , Students, Dental , Dental Clinics , Dentistry , Social Perception , Cross-Sectional Studies/methods , Surveys and Questionnaires , Quality ImprovementABSTRACT
Abstract The globalization of the pharmaceutical market has enabled access to a considerable number of new medicinal products. Consequently, the circulation of substandard medicinal products has also increased. To minimize this problem, post-marketing quality sampling and testing programs are performed to monitor and confirm that the medicinal products available in the market meet appropriate quality requirements. In this review, the post-approval sampling and testing procedures of six regulatory authorities were compared with the goal of strengthening these market surveillance systems. Similarities were observed between the procedures adopted by different regulatory authorities. However, the agencies were not always transparent about the results of these monitoring procedures. A probable mismatch between the registration procedures and the quality requirements listed in official compendiums was observed, which resulted in dissonance and contradiction between the specifications approved by the regulatory authorities and those required in the pharmacopeias. Therefore, strengthening harmonization projects related to these activities can help minimize such difficulties.
Subject(s)
Pharmaceutical Preparations/analysis , Pharmaceutical Preparations/standards , Sampling Studies , Quality Control , Total Quality Management , MarketingABSTRACT
Abstract There is no biodistribution or imaging data on 99mtechnetium (Tc)-hexamethyl propylamine oxime (HMPAO)-labeled platelets in the literature. The current study aimed to present updated information about the clinical procedures for preparation and use of labeled platelets. Following two-step centrifugation at 1500 and 2500 rpm, the platelets were extracted from whole blood into platelet-rich plasma (PRP) above the buffy coat and then from PRP into a platelet pellet at the bottom of the tube. The 99mTc-HMPAO-labeled platelets were inspected for purity, viability, release of 99mTc from platelets, and sterility. Also, microscopic examination and thin layer chromatography (TLC) were performed. Biodistribution was assessed following necropsy in BALB/c mice and through imaging of New Zealand rabbits. The separation ratio was estimated at 98%, and radiochemical purity was measured to be 80%. The labeling efficiency was above 30% in more than half of the assays (range: 17-43%). The release of 99mTc from platelets was 9% per hour at 37ºC. After 24 hours, stability was estimated at 54% in the human serum. The target organs of mice included the spleen and liver. In rabbits, the imaging results indicated liver as the target organ. Thyroid uptake was negligible up to 90 minutes. Based on the findings, extraction of platelets and labeling them with 99mTc-HMPAO is a feasible and safe approach in routine practice.
Subject(s)
Humans , Animals , Male , Mice , Quality Control , Blood Platelets/classification , Technetium Tc 99m Exametazime , Methods , Spleen , Chromatography, Thin Layer/methods , Efficiency/classification , Platelet-Rich Plasma , LiverABSTRACT
Objetivo: Identificar as causas de não conformidades em Produtos para Saúde distribuídos por um centro de esterilização localizado na região metropolitana de Belo Horizonte, MG, Brasil. Métodos: Estudo descritivo, de natureza quantitativa que foi realizado entre janeiro e dezembro de 2019. Os dados foram coletados através de um instrumento estruturado para avaliação sistemática dos itens e analisados estatisticamente de forma descritiva. Resultados: Foram avaliados 2.944 produtos para saúde, que variou de 66 a 284/mês, com média de 245 (±56). Foram identificados 24 itens inadequados o que gerou uma taxa de não conformidade de 0,96%. As principais causas foram atribuídas à embalagem manchada (20,8%), aos produtos para saúde sem identificação (20,8%), problemas na selagem (16,6%) e embalagem violada (12,5%). Conclusão: As principais causas de não conformidades encontradas sugerem a realização de um controle criterioso de qualidade em cada etapa do reprocessamento de materiais para não comprometer a segurança do paciente.
Objective: To identify the causes of non-conformities in Health Products distributed by a sterilization center located in the metropolitan region of Belo Horizonte, MG, Brazil. Methods: This was a study described, of a quantitative nature that was carried out between January and December 2019. The data were collected through a structured instrument for systematic evaluation of the items and analyzed using the technique of descriptive statistics. Results: A total of 2,944 health products were evaluated during the study period, which ranged from 66 to 284/month, with an average of 245 (± 56). There were 24 inappropriate items that generated a noncompliance rate of 0.96%. The main causes were attributed to stained packaging (20.8%), health products without identification (20.8%), sealing problems (16.6%) and violated packaging (12.5%). Conclusion: The main causes of nonconformities found in this study suggest the performance of a careful quality control at each stage of the reprocessing cycle so as not to compromise patient safety.
Subject(s)
Product Surveillance, Postmarketing , Quality Control , Surgical Instruments , Sterilization , NursingABSTRACT
Background: A national proficiency test (PT) programme is not currently implemented in most low-income countries. However, participation in such PT programmes assists improves test performance and result accuracy.Objective: This study assessed how well 11 government hospital laboratories performed 18 basic clinical chemistry tests and identified areas needing improvement.Methods: A cross-sectional study was carried out by the Division of Laboratories of the Ministry of Health of Togo from 01 July 2016 to 31 December 2016. The test performance was evaluated using panels provided by One World Accuracy, Canada (Vancouver). The Clinical Laboratory Improvement Amendments criteria were used in evaluating the laboratories, and their success rates were compared with the World Health Organization Regional Office for Africa's target of 80%.Results: The overall rate of acceptable results at the laboratories was over 80% for glucose, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, alkaline phosphatase and triglycerides tests. The laboratories using fully automated spectrophotometers had an acceptable results rate of 89% (p = 0.001). The overall performance of the laboratories by cycles varied from 71% to 82%.Conclusion: This national PT programme identified the tests, which laboratories must improve their performance (urea, creatinine, uric acid, bilirubin, cholesterol, total protein, calcium, magnesium, phosphorus). It demonstrated the need for the use of routine appropriate internal quality control in all laboratories. The proficiency test programme should be extended to all clinical laboratories and target all biology disciplines
Subject(s)
Male , Female , Quality Control , Clinical Chemistry Tests , Biochemistry , Clinical Laboratory Techniques , Engineering , Academic PerformanceABSTRACT
Objective: This study aimed to determine the sigma metrics of analytes when using different total allowable error guidelines.Methods: A retrospective analysis was performed on 19 general chemistry analytes at Charlotte Maxeke Johannesburg Academic Hospital in South Africa between January 2017 and December 2017. Sigma metrics were calculated on two identical analysers, using internal quality control data and total allowable error guidelines from the Ricos biological variation database and three alternative sources (the Royal College of Pathologists of Australasia, the Clinical Laboratory Improvements Amendment, and the European Federation of Clinical Chemistry and Laboratory Medicine). Results: The sigma performance was similar on both analysers but varied based on the guideline used, with the Clinical Laboratory Improvements Amendment guidelines resulting in the best sigma metrics (53% of analytes on one analyser and 46% on the other had acceptable sigma metrics) and the Royal College of Pathologists of Australia guidelines being the most stringent (21% and 23%). Sodium and chloride performed poorly across all guidelines (sigma < 3). There were also month-to-month variations that may result in acceptable sigma despite poor performance during certain months.Conclusion: The sigma varies greatly depending on the total allowable error, but could be a valuable tool to save time and decrease costs in high-volume laboratories. Sigma metrics calculations need to be standardised
Subject(s)
Quality Control , Pathology , Total Quality Management , Clinical Chemistry Tests , Diagnostic Errors , LaboratoriesABSTRACT
Lonicerae Japonicae Flos, as common Chinese medicine, has been used for thousands of years in the treatment of inflammation and infectious diseases with definite efficacies. The complex composition of Lonicerae Japonicae Flos results in its extensive pharmacological effects, so the assessment of its quality by only a few index components is not comprehensive. Guided by the quality marker(Q-marker), the present study comprehensively analyzed and predicted the quality connotation of Lonicerae Japonicae Flos based on the chemical composition and component transfer, the phylogenetic relationship, chemical composition effectiveness, measurability, and specificity. Chlorogenic acid, isochlorogenic acids A, B, and C, luteoloside, rutin, sweroside, and secoxyloganin were predicted as candidate Q-markers of Lonicerae Japonicae Flos.
Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/chemistry , Flowers/chemistry , Lonicera/chemistry , Phylogeny , Quality ControlABSTRACT
According to the polarity of different components in Sanpian Decoction, two fingerprints were established. Then the substance benchmark freeze-dried powder of 15 batches of Sanpian Decoction was prepared, followed by the determination of the fingerprints, index component content, and dry extract rates, the identification of attribution of characteristic peaks, and the calculation of similarities between these fingerprints and the reference(R), the content and transfer rate ranges of ferulic acid, sinapine thiocyanate, liquiritin, and glycyrrhizic acid, and the dry extract rate range. The results showed that the similarities of 15 batches of the substance benchmark fingerprints with R were all greater than 0.900.Further summarization of the characteristic peaks revealed that there were a total of 20 characteristic peaks in fingerprint 1, among which, eight were from Sinapis Semen, four from Paeoniae Radix Alba, six from Chuanxiong Rhizoma, and two from Glycyrrhizae Radix et Rhizoma. A total of 16 characteristic peaks were observed in fingerprint 2, including one from Sinapis Semen, three from Paeoniae Radix Alba, eight from Chuanxiong Rhizoma, and four from Glycyrrhizae Radix et Rhizoma. The average dry extract rate of 15 batches of substance benchmarks was 18.25%, with a dry extract rate range of 16.28%-20.76%. The index component content and transfer rate ranges were listed as follows: 0.15%-0.18% and 38.81%-58.05% for ferulic acid; 0.26%-0.42% and 36.51%-51.02% for sinapine thiocyanate; 0.09%-0.15% and 48.80%-76.61% for liquiritin; 0.13%-0.24% and 23.45%-35.61% for glycyrrhizic acid. The fingerprint, dry extract rate, and index component content determination was combined for analyzing the quality value transfer of substance benchmarks in the classic prescription Sanpian Decoction.The established quality evaluation method for the substance benchmarks was stable and feasible, which has provided a basis for the quality control of Sanpian Decoction and the follow-up development of related preparations.
Subject(s)
Benchmarking , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Glycyrrhizic Acid/analysis , Paeonia , Quality Control , ThiocyanatesABSTRACT
The methods for determining the characteristic chromatogram and index components content of Xuanfu Daizhe Decoction were established to provide a scientific basis for the quality evaluation of substance benchmarks and preparations. Eighteen batches of Xuanfu Daizhe Decoction were prepared with the decoction pieces of different batches and of the same batch were prepared respectively, and the HPLC characteristic chromatograms of these samples were established. The similarities of the chromatographic fingerprints were analyzed. With liquiritin, glycyrrhizic acid, 6-gingerol, ginsenoside Rg_1, and ginsenoside Re as index components, the high performance liquid chromatography was established for content determination with no more than 70%-130% of the mass average as the limit. The results showed that there were 19 characteristic peaks corresponding to the characteristic chromatograms of 18 batches of Xuanfu Daizhe Decoction, including 8 peaks representing liquiritin, 1,5-O-dicaffeoylqunic acid, ginsenoside Rg_1, ginsenoside Re, 1-O-acetyl britannilactone, ginsenoside Rb_1, glycyrrhizic acid, and 6-gingerol, and the fingerprint similarity was greater than 0.97. The contents of liquiritin, glycyrrhizic acid, 6-gingerol, and ginsenosides Rg_1 + Re in the prepared Xuanfu Daizhe Decoction samples were 0.53%-0.86%, 0.61%-1.2%, 0.023%-0.068%, and 0.33%-0.66%, respectively. Except for several batches, most batches of Xuanfu Daizhe Decoction showed stable contents of index components, with no discrete values. The characteristic chromatograms and index components content characterized the information of Inulae Flos, Ginseng Radix et Rhizoma, Glycyrrhizae Radix et Rhizoma, and Zingiberis Rhizoma Recens in Xuanfu Daizhe Decoction. This study provides a scientific basis for the further research on the key chemical properties of substance benchmark and preparations of Xuanfu Daizhe Decoction.
Subject(s)
Benchmarking , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/chemistry , Ginsenosides/analysis , Glycyrrhizic Acid/analysis , Quality ControlABSTRACT
The fingerprint of Boenninghausenia albiflora var. albiflora was established by ultra performance liquid chromatography(UPLC), and the content of 12 active components including chlorogenic acid was determined. Multivariate statistical analysis was used to explore the indicator components of B. albiflora var. albiflora and a comprehensive evaluation system was created for the quality of B. albiflora var. albiflora. In this study, 33 batches of B. albiflora var. albiflora with different sources were collected and studied, and the UPLC fingerprint of B. albiflora var. albiflora was developed. There were 37 common peaks, of which 12 components were identified, and the content of these 12 components was measured. In combination of the common peaks and the content of chemical components, multivariate statistical analysis was performed, and the results showed that 6 components [daphnoretin, isoimperatorin, astragalin, imperatorin, neochlorogenic acid, and isoquercitrin(weight coefficient>0.1)] were selected as chemical markers for the quality of B. albiflora var. albiflora. Technique for order of preference by similarity to ideal solution(TOPSIS) analysis and chemometrics revealed that the quality of S32, S28 and S29 were superior, while that of S12, S7 and S16 were inferior. The quality evaluation method of B. albiflora var. albiflora constructed in this study was accurate and reliable, with simpleness and easiness to operate. It is suggested that the 6 above-mentioned active components could be used as indicator components for quality control of B. albiflora var. al-biflora. The samples were harvested during the flowering and fruiting period, which is from the beginning of July to the end of August.