[Establishment of the quality management system for occupational diseases diagnosis].

The quality management system of occupational diseases diagnosis is belonged to one part of the hospital quality management system. It must be adhered to the quality management concept of comprehensive, full staff and whole process. To establish and improve the quality management system should be included: (1) Formulated a quality management manual for occupational disease diagnosis, including organization construction, rules and regulations, responsibilities, work flow, operating procedures and clinical pathways, standard instrument, etc. (2) Managed the document of occupational diseases diagnosis. (3) The continuous improvement of quality management. The quality management of occupational diseases diagnosis focuses on the mastery and implementation of the manual by employees, which is reflected in the continuous improvement of daily work, internal assessment and external assessment.

Evaluación de la gestión de calidad en la red de bibliotecas médicas de Villa Clara / Evaluation of quality management in Villa Clara medical library network

La calidad es una exigencia vigente a nivel mundial en el área de la educación, a su vez constituye un indicador fundamental para las instituciones educativas, sujetas a proporcionar un servicio de excelencia. Por ello resulta necesario evaluar la gestión de calidad en las bibliotecas médicas de Villa Clara, de manera tal que se contribuya al mejoramiento de su funcionamiento y lograr un mayor nivel de satisfacción de las necesidades informativas de sus usuarios. Se tomaron como referentes teóricos el modelo de evaluación de bibliotecas universitarias cubanas, y los documentos normativos y teórico-metodológicos del Centro Nacional de Información sobre la temática.

Quality is a worldwide requirement in the education area, and at the same time it is a fundamental indicator for educational institutions which are subjected to provide a service of excellence. For this reason, evaluating the quality management of medical libraries in Villa Clara is a necessity, in order to contribute to the improvement of their functioning and to achieve a higher level of satisfaction of their users' information needs. The evaluation model for Cuban university libraries and the normative, theoretical and methodological documents of the National Information Center of Medical Sciences regarding this subject were taken as theoretical references.

Condition optimization of eco-friendly RP-HPLC and MCR methods via Box-Behnken design and six sigma approach for detecting antibiotic residues.

A precise, Eco-friendly, and highly sensitive RP-HPLC method was employed using quality-by-design principles to concurrently identify cephalexin and cefixime residues in the manufacturing machines using a hypersil BDS C18 column (250 × 4.6 mm, 5 µm) at wavelength 254 nm. The Box-Behnken design was applied to obtain the best chromatographic conditions with the fewest possible trials. Three independent factors viz organic composition, flow rate, and pH were used to assess their effects on the responses' resolution and retention time. Overlay plot and desirability functions were implemented to predict responses of the high resolution and relatively short retention time using a mobile phase composed of acidic water: acetonitrile (85:15, v/v) at pH 4.5 adjusted by phosphoric acid with a flow rate of 2.0 mL/min. The spectral overlapping of the drugs was successfully resolved by the mean centering ratio (MCR) spectra approach at 261 nm and 298 nm for cephalexin and cefixime, respectively. Good linearity results were obtained for the suggested HPLC and MCR methods over the concentration range of (0.05-10 ppm) and (5-30 ppm) with a detection limit of 0.003, 0.004, 0.26, and 0.23 ppm, and quantitation limits of 0.008, 0.013, 0.79, and 0.68 ppm for cephalexin and cefixime, respectively, with a correlation coefficient of ≥ 0.9998 and good swab recovery results of 99-99.5%. A process capability index was accomplished for chemical and micro results, illustrating that both are extremely capable. The suggested method was effectively validated using ICH recommendations.

Quality Management System in Clinical Digital Pathology Operations at a Tertiary Cancer Center.

Digital pathology workflows can improve pathology operations by allowing reliable and fast retrieval of digital images, digitally reviewing pathology slides, enabling remote work and telepathology, use of computer-aided tools, and sharing of digital images for research and educational purposes. The need for quality systems is a prerequisite for successful clinical-grade digital pathology adoption and patient safety. In this article, we describe the development of a structured digital pathology laboratory quality management system (QMS) for clinical digital pathology operations at Memorial Sloan Kettering Cancer Center (MSK). This digital pathology-specific QMS development stemmed from the gaps that were identified when MSK integrated digital pathology into its clinical practice. The digital scan team in conjunction with the Department of Pathology and Laboratory Medicine quality team developed a QMS tailored to the scanning operation to support departmental and institutional needs. As a first step, systemic mapping of the digital pathology operations identified the prescan, scan, and postscan processes; instrumentation; and staffing involved in the digital pathology operation. Next, gaps identified in quality control and quality assurance measures led to the development of standard operating procedures and training material for the different roles and workflows in the process. All digital pathology-related documents were subject to regulatory review and approval by departmental leadership. The quality essentials were developed into an extensive Digital Pathology Quality Essentials framework to specifically address the needs of the growing clinical use of digital pathology technologies. Using the unique digital experience gained at MSK, we present our recommendations for QMS for large-scale digital pathology operations in clinical settings.

A importância do Sistema Único de Saúde para o aprimoramento da Saúde Coletiva / The importance of the Unified Health System for improving Public Health

O artigo pretende resgatar a relevância do Sistema Único de Saúde (SUS) como Política Pública que alicerça a promoção e prevenção da saúde coletiva. A metodologia utilizada foi a revisão integrativa da literatura a partir da busca de artigos em Lilacs, MedLine e Scielo, utilizando os descritores: SUS, Saúde Coletiva e Pública e História da Saúde. Procedeu-se ao cruzamento dos descritores para elucidar as implicações de ações de promoção e prevenção em saúde para o aprimoramento da saúde coletiva.a utilização de escalas como a PUSH na avaliação dos cuidados prestados é essencial para nortear o atendimento.(AU)

This article aims to rescue the relevance of the Unified Health System (SUS) as a Public Policy that underpins the promotion and prevention of collective health. The methodology used was an integrative literature review from the search for articles in Lilacs, MedLine and Scielo databases, using the descriptors: SUS, Collective and Public Health, History of Health. The descriptors were crossed to elucidate the implications of actions with promotion and prevention for the improvement of collective health(AU)

Este artículo tiene como objetivo destacar la importancia del Sistema Único de Salud (SUS) como política pública que sustenta la promoción y prevención de la salud colectiva. La metodología utilizada fue una revisión bibliográfica integradora basada en la búsqueda de artículos en Lilacs, MedLine y Scielo, utilizando los descriptores: SUS, Salud Colectiva y Pública e Historia de la Salud. Los descriptores fueron cruzados para dilucidar las implicaciones de las acciones de promoción y prevención de la salud en la mejora de la salud colectiva.(AU)

Adaptarnos para sobrevivir. Requerimientos de un nuevo paradigma / Adapting to survive. Requirements for a new paradigm

A lo largo de la historia, el rol del bioquímico en el laboratorio clínico ha ido mutando, adaptándose a nuevos paradigmas, consecuencia del avance de la tecnología1 y la informática, de la presión externa ejercida por las empresas proveedoras de reactivos que reducen el tiempo útil de los equipos, aumentando su tasa de recambio, de una medicina más compleja que impone nuevos desafíos diagnósticos y de los cambios sociales que se ven reflejados en una alteración en el orden de los valores adoptado por las nuevas generaciones de profesionales que conviven con otras, provocando "turbulencia generacional" en los lugares de trabajo. Los laboratorios necesitan hoy someterse a una reingeniería de sus procesos, descartar aquellos que no agreguen valor, que causan fugas innecesarias de insumos, personas y tiempo e intervenir la cultura organizacional de manera integral, para adaptarse a las exigencias que la actualidad requiere, donde la calidad, la seguridad y la sostenibilidad son los principales protagonistas )AU)

Over time, the role of the biochemist in the clinical laboratory has been changing, adapting to new paradigms, as a consequence of the advance of technology and informatics, of the external pressure exerted by the companies supplying reagents that reduce the useful time of the equipment, increasing its replacement rate, of a more complex medicine that imposes new diagnostic challenges, and of social changes that are reflected in an alteration in the values adopted by the new generations of professionals who coexist with others, causing "generational turbulence" in the workplace. Laboratories today need to reengineer their processes, eliminate those that do not add value, that cause unnecessary waste of supplies, people and time, and intervene in the organizational culture in a comprehensive manner, in order to adapt to the demands of today's world, where quality, safety, and sustainability are the main drivers (AU)

Gestão do Trabalho em Saúde: experiências na atenção, gestão, participação e educação / Health Work Management: experiences in care, management, participation and education

Este livro é resultado de uma parceria entre OPAS, a Secretaria Estadual de Saúde do Tocantins e a Associação Brasileira da Rede Unida, desenvolvida em 2017. Apresenta diferentes interfaces, todas elas permeando o mundo de trabalho na gestão, no ensino e na atenção, tendo como pano de fundo a produção do cuidado, a organização da gestão do trabalho e da educação que são entrelaçados com processos que constituem sujeitos e subjetivações na construção do Sistema Único de Saúde (SUS), tal como está emoldurado em nossa Constituição Federal, fruto de lutas e conquistas de muitas e muitos por uma atenção integral, universal e com equidade. O debate de gestão de trabalho que este livro propõe, reabre possibilidades, possibilita a construção de uma agenda para nova política de saúde. As experiências desse livro abrem espaços e possibilidades dos novos e inusitados, produtoras de subjetividades conectadas à atenção em saúde que emancipa e que extrapola a dimensão biomédica; traz a micropolítica como espaço de desejos, criatividade e inovações. Espaços que se conectam/entrelaçam em suas vivências, constituindo cola, alicerce para construções de coletivos e outra políticas de vida. Este livro é resultado de uma parceria entre OPAS, a Secretaria Estadual de Saúde do Tocantins e a Associação Brasileira da Rede Unida, desenvolvida em 2017. Apresenta diferentes interfaces, todas elas permeando o mundo de trabalho na gestão, no ensino e na atenção, tendo como pano de fundo a produção do cuidado, a organização da gestão do trabalho e da educação que são entrelaçados com processos que constituem sujeitos e subjetivações na construção do Sistema Único de Saúde (SUS), tal como está emoldurado em nossa Constituição Federal, fruto de lutas e conquistas de muitas e muitos por uma atenção integral, universal e com equidade. O debate de gestão de trabalho que este livro propõe, reabre possibilidades, possibilita a construção de uma agenda para nova política de saúde. As experiências desse livro abrem espaços e possibilidades dos novos e inusitados, produtoras de subjetividades conectadas à atenção em saúde que emancipa e que extrapola a dimensão biomédica; traz a micropolítica como espaço de desejos, criatividade e inovações. Espaços que se conectam/entrelaçam em suas vivências, constituindo cola, alicerce para construções de coletivos e outra políticas de vida.

Improving efficiency and reducing costs in robotic surgery: a Lean Six Sigma approach to optimize turnover time.

Operating room (OR) turnover time (TOT) is the time it takes to prepare an OR for the next surgery after the previous one has been completed. Reducing OR TOT can improve the efficiency of the OR, reduce costs, and improve surgeons' and patients' satisfaction. The objective of this study is to evaluate the effectiveness of an operating room (OR) turnover time (TOT) reduction initiative using the Lean Six Sigma methodology (DMAIC) in the bariatric and thoracic service lines. Performance improvement strategies consist of simplifying steps (surgical tray optimization) and concurrent steps (parallel task execution). We compared 2-month pre-implementation vs. post-implementation. A paired t-test was used to assess whether the difference in the measurements was statistically significant. The study found that TOT was reduced by 15.6% from an average of 35.6 ± 8.1 to minutes 30.09 ± 9.7 min (p < 0.05). Specifically, in the bariatric service line, TOT was reduced by 17.15% and in the thoracic service line, TOT was reduced by 9.6%. No adverse events related to the initiative were reported. The results of this study indicate that the TOT reduction initiative was effective in reducing TOT. The efficient use of operating rooms is crucial in hospital management, as it not only impacts finances but also affects the satisfaction of surgical teams and patients. This study shows the effectiveness of Lean Six Sigma methodology in reducing TOT and improving the efficiency in the OR.

Quality Care in Outpatient Chemotherapy. Design and Validation of the Novel Care Quality Ambulatory Instrument / Cuidado con calidad en quimioterapia ambulatoria. Diseño y validación del nuevo instrumento Care Quality Ambulatory / Cuidado com qualidade em quimioterapia ambulatória. Desenho e validação do novo instrumento Care Quality Ambulatory

Introduction: Neither validated scales nor scales translated into Spanish currently exist to evaluate the perception of quality care in people receiving outpatient chemotherapy, despite their usefulness in evaluating the care provided by nurses and in promoting changes in the delivery of these services. Objective: To design and validate the novel Care Quality Ambulatory-I (CQAMB-I) instrument in outpatient chemotherapy services. Materials and methods: This is an instrument validation study carried out in three stages: literature review, design, and validation of the instrument. Content validation was performed with 14 specialists with at least a master's degree and experience in chemotherapy or quality services; face validation was carried out through a pilot test with 31 participants diagnosed with cancer who received curative chemotherapy, and construct validation was carried out through an exploratory factor analysis with 436 users who received outpatient chemotherapy with curative intent. Results: A total of 15 items were removed in the content validation stage; none were removed in face validation. In construct validation, participants had a median age of 56 years, a median treatment time of 5 months, and breast cancer was the most commonly diagnosed form of cancer. Eighteen models were run, 30 items were removed, 6 factors emerged, and a KMO of 0.80 and a Cronbach's alpha of 0.82 were obtained. Conclusion: The CQAMB-I proved to be valid and reliable for the evaluation of quality care in outpatient chemotherapy services. Additionally, it enabled expanding the conception of such care beyond the attributes of structure, process, and outcome.

Introducción: no existen escalas validadas, ni traducidas al español para evaluar la percepción del cuidado con calidad en personas que reciben quimioterapia ambulatoria, a pesar de su utilidad para evaluar la prestación de servicios enfermeros y generar cambios en la entrega de estos. Objetivo: diseñar y validar el nuevo instrumento Care Quality Ambulatory-I (CQAMB-I) en servicios de quimioterapia ambulatoria. Materiales y métodos: estudio de validación de instrumentos en tres fases: revisión de la literatura, diseño y validación del instrumento. Se realizó validación de contenido con 14 expertos con formación mínima de maestría y experiencia en servicios de quimioterapia o calidad; validación facial a través de prueba piloto con 31 participantes con diagnóstico de cáncer que recibían quimioterapia curativa; y validación de constructo por medio de un análisis factorial exploratorio con 436 usuarios que recibían quimioterapia ambulatoria con intención curativa. Resultados: en la validación de contenido se eliminaron 15 ítems; en la validación facial no se eliminó ninguno; y en la validación de constructo los participantes tuvieron una mediana de edad de 56 años, mediana de tiempo de tratamiento de 5 meses y cáncer de mama como el más diagnosticado. Se ejecutaron 18 modelos, se eliminaron 30 ítems, emergieron 6 factores y se obtuvo un KMO de 0.80 y un alpha de Cronbach de 0.82. Conclusión: el instrumento CQAMB-I demostró ser válido y confiable para evaluar el cuidado con calidad en servicios de quimioterapia ambulatoria y, adicionalmente, permitió ampliar la concepción de este más allá de los atributos de estructura, proceso y resultado.

Introdução: não existem escalas validadas nem traduzidas ao espanhol para avaliar a percepção do cuidado com qualidade em pessoas que recebem quimioterapia ambulatória, apesar de sua utilidade para avaliar a prestação de serviços de enfermagem e gerar mudanças na entrega destes. Objetivo: desenhar e validar o novo instrumento Care Quality Ambulatory-I (CQAMB-I) em serviços de quimioterapia ambulatória. Materiais e método: estudo de validação de instrumentos em três fases: revisão da literatura, desenho e validação do instrumento. Foi realizada validação de conteúdo com 14 especialistas com formação mínima de mestrado e experiência em serviços de quimioterapia ou qualidade; validação facial por meio de teste-piloto com 31 participantes com diagnóstico de câncer que recebiam quimioterapia curativa e validação de constructo por meio de uma análise fatorial exploratória com 436 usuários que recebiam quimioterapia ambulatória com intenção curativa. Resultados: na validação de conteúdo, foram eliminados 15 itens; na validação facial, não foi eliminado nenhum; na validação de constructo, os participantes tiveram uma média de idade de 56 anos, média de tempo de tratamento de 5 meses e câncer de mama como o mais diagnosticado. Foram executados 18 modelos, foram eliminados 30 itens, emergidos 6 fatores e obtido um KMO de 0,80 e um alpha de Cronbach de 0,82. Conclusões: o instrumento CQAMB-I demonstrou ser válido e confiável para avaliar o cuidado com qualidade em serviços de quimioterapia ambulatória e, além disso, permitiu ampliar a concepção deste mais além dos atributos de estrutura, processo e resultado.

Análise do fluxo de valor no processo de alta de uma unidade de terapia intensiva / Analysis of the value stream of the intensive care unit discharge process / Análisis de flujo de valor en el proceso de alta de una unidad de cuidados intensivos

Objetivo: Realizar o mapeamento do fluxo de valor, propondo melhorias no processo de alta da unidade de terapia intensiva para unidade de internação. Métodos: Trata-se de um estudo descritivo, prospectivo e exploratório que comparou o mesmo processo pré e pósintervenção. Utilizou-se a ferramenta de mapeamento de fluxo de valor em uma unidade de terapia intensiva de um hospital de grande porte localizado na cidade de São Paulo com a proposta de identificar pontos críticos e propor ações melhoria. Resultados: A equipe assistencial da unidade realizou o mapeamento do fluxo de valor inicial, identificando oportunidades de melhoria como a implantação de ações de mudanças de fluxos, treinamento e revisão de tarefas. Com a elaboração do mapa de fluxo de valor atual, pode destacar uma redução no tempo da alta da unidade de terapia intensiva em 97 minutos, o que representou aproximadamente 26,7% do tempo total. Conclusão: A utilização da ferramenta Mapa de Fluxo de Valor teve implicações positivas para a gestão por processos pela possibilidade da visão sistêmica de todas as etapas, identificação de oportunidades e melhoria prática assistencial. (AU)

Objective: To realize the value stream mapping proposing improvements of the intensive care unit discharge process. Methods: A descriptive, prospective and exploratory study that compared two moments of a process. The value stream mapping tool was used in an intensive care unit of a hospital located in the city of São Paulo with the purpose of identifying critical points and proposing improvement actions. Results: The unit's care team carried out the mapping of the initial value flow, identifying opportunities for improvement such as the implementation of actions to change flows, training and task review. With the elaboration of the current value flow map, a reduction in the time of discharge from the intensive care unit of 97 minutes can be highlighted, which represented approximately 26.7% of the total time. Conclusion: The use of the Value Stream Map tool had positive implications for process management due to the possibility of a systemic view of all stages, identification of opportunities and improvement in care practice. (AU)

Objetivo: Realizar el mapeo de la cadena de proponiendo mejoras en el proceso de alta de la unidad de cuidados intensivos a la unidad de hospitalización. Métodos: Se trata de un estudio descriptivo, prospectivo y exploratorio que comparó el mismo proceso pre y posintervención. La herramienta de mapeo de la cadena de valor se utilizó en una unidad de cuidados intensivos de un gran hospital ubicado en la ciudad de São Paulo con el propósito de identificar puntos críticos y proponer acciones de mejora. Resultados: El equipo de atención de la unidad realizó el mapeo del flujo de valor inicial, identificando oportunidades de mejora como la implementación de acciones de cambio de flujos, capacitación y revisión de tareas. Con la elaboración del mapa de flujo de valor actual, se puede resaltar una reducción en el tiempo de alta de la unidad de cuidados intensivos de 97 minutos, lo que representó aproximadamente el 26,7% del tiempo total. Conclusión: El uso de la herramienta para mapear el flujo tiene implicaciones positivas para la gestión de procesos debido a la posibilidad de una visión sistémica de todas las etapas, identificación de oportunidades y mejora en la práctica asistencial. (AU)

Streamlining and Consistency in Surgery: Lean Six Sigma to Improve Operating Room Efficiency.

BACKGROUND: Improving perioperative efficiency helps reduce unnecessary surgical expenditure, increase operating room throughput, improve patient safety, and enhance staff and patient satisfaction. Lean Six Sigma (LSS) is a quality improvement model that has been successfully applied to eliminate inefficiencies in the business sector but has not yet been widely adopted in medicine. This study investigates the adaptation of LSS to improve operative efficiency for plastic surgery procedures. METHODS: The authors followed the define, measure, analyze, improve, and control phases to implement LSS. The key outcome measures gathered were operative times, including the cut-to-close time, and the total time the patient spent in the operating room. RESULTS: The study included a total of 181 patients who underwent immediate bilateral deep inferior epigastric perforator flap breast reconstruction between January of 2016 and December of 2019. The LSS interventions were associated with a decrease in total operative time from 636.36 minutes to 530.35 minutes, and a decrease in the time between incision to closure from 555.16 minutes to 458.85 minutes for a bilateral mastectomy with immediate deep inferior epigastric artery flap breast reconstruction. CONCLUSIONS: This study demonstrates that LSS is useful to improve perioperative efficiency during complex plastic surgery procedures. The workflow of the procedure was improved by determining the optimal spatial positioning and distinct roles for each surgeon and preparing surgeon-specific surgical trays. Two process maps were developed to visualize the positioning of the surgeons during each stage of the procedure and depict the parallel workflow that helped improve intraoperative efficiency.

Quality and process improvement of the multidisciplinary Heart Team meeting using Lean Six Sigma.

INTRODUCTION: The Heart Team is a multidisciplinary meeting for shared decision-making in cardiology and cardiothoracic surgery. A quality improvement project to optimise the Heart Team was initiated after the merger of the cardiac centres of Amsterdam University Medical Centre. METHODS: Lean Six Sigma was applied with the purpose of improving efficiency and quality of care. Qualitative and quantitative analyses supported the multidisciplinary team during quality improvement sessions. Lean Six Sigma tools included process mapping, gemba walks, root cause analysis, line balancing, first time right, standardised work and poka-yoke. INTERVENTIONS: Seven areas of improvement were introduced. Key elements were the improvement of the patient referral process, introduction of a structured agenda, task division and balanced planning of patients, better exchange of information, improved availability of diagnostics and supportive tools and information technology. Work agreements were introduced to support a positive work culture and mutual respect. RESULTS: Lean Six Sigma designed an optimised Heart Team to improve efficiency by better resource utilisation, first time right decision-making, patient selection, complete and better access to information and elimination of waste. It leads to higher quality of decision-making by involving physicians in a more structured preparation, attendance of an imaging cardiologist, meeting duration within limits, installation of standard operating procedures, increased involvement of the referring cardiologists and a better engaged team. CONCLUSIONS: Heart Teams are essential to make evidence-based, patient-centred treatment plans for optimal patient outcomes. However, clinical practice and experience showed that it is challenging to have an efficient and effective discussion with complete patient information and to bring together healthcare professionals. The application of Lean Six Sigma resulted in an optimised Heart Team and created a best practice design for patient-centred, evidence-based decision-making. After implementation and process stability, a postintervention analysis could clarify long-term success and sustainability.

Contribuições do núcleo interno de regulação para a segurança do paciente / Contributions of the regulatory inner core to patient safety / Aportes del núcleo interno normativo para la seguridad del paciente

Objetivo: identificar as contribuições do Núcleo Interno de Regulação para a segurança do paciente. Método: pesquisa qualitativa desenvolvida entre agosto a outubro de 2020. Foram realizadas entrevistas audiogravadas junto a 13 profissionais que atuavam nas enfermarias, no pronto-socorro, na gestão da qualidade e no Núcleo Interno de Regulação. Os dados foram analisados com o auxílio do software IraMuteq® e as etapas propostas por Creswell. Resultados: os achados revelaram que o Núcleo Interno de Regulação contribui para a segurança do paciente, entornando as metas instituídas: comunicação efetiva; identificação do paciente; redução do risco de infecções associadas aos cuidados em saúde - a pandemia de COVID-19 foi apresentada como um importante dado; segurança para cirurgia, uma vez que agiliza o acesso ao hospital para procedimento cirúrgico; e diminuição de filas de espera. Ainda, contribui para prevenir complicações decorrentes de quedas, pois o paciente pode ser alocado com agilidade num leito seguro. Por fim, o enfermeiro, no seu papel de liderança do serviço e como elo para a gerência do cuidado seguro, também se mostrou importante. Conclusão: embora algumas fragilidades tenham sido detectadas, a contribuição do Núcleo Interno de Regulação se sobressai por fortalecer as metas da segurança do paciente. Em razão disso, reafirma-se a importância de fluxos regulatórios na perspectiva de gestão de leitos hospitalares, assim como os preceitos da segurança do paciente almejada pelos gestores. Não obstante, o enfermeiro atua como elo entre esses dois cenários.(AU)

Objective: to identify the contributions of the Internal Regulation Core to patient safety. Method: qualitative research carried out between August and October 2020. Audio-recorded interviews were carried out with 13 professionals who worked in the wards, in the emergency room, in quality management and in the Internal Regulation Center. Data were analyzed using the IraMuteq® software and the steps proposed by Creswell. Results: the findings revealed that the Internal Regulation Nucleus contributes to patient safety, bypassing the established goals: effective communication; patient identification; reduction in the risk of infections associated with health care - the COVID-19 pandemic was presented as an important fact; safety for surgery, as it speeds up access to the hospital for a surgical procedure; and reduction of queues. It also helps to prevent complications resulting from falls, as the patient can be quickly allocated to a safe bed. Finally, the nurse, in his role as a leader in the service and as a link in the management of safe care, also proved to be important. Conclusion: although some weaknesses were detected, the contribution of the Internal Regulation Center stands out for strengthening patient safety goals. As a result, the importance of regulatory flows from the perspective of hospital bed management is reaffirmed, as well as the precepts of patient safety desired by managers. Nevertheless, the nurse acts as a link between these two scenarios.(AU)

Objetivo: identificar los aportes del Núcleo Interno Normativo para la seguridad del paciente. Método: investigación cualitativa desarrollada de agosto a octubre de 2020. Se realizaron entrevistas audiograbadas a 13 profesionales que trabajaban en las salas, en el servicio de urgencias, en la Gestión de Calidad y en el Núcleo Interno Normativo. Los datos fueron analizados con la ayuda del software IraMuteq® y los pasos propuestos por Creswell. Resultados: los hallazgos revelaron que el Núcleo Interno Normativo contribuye a la seguridad del paciente, desbordando los objetivos establecidos: comunicación eficaz; identificación del paciente; reducción del riesgo de infecciones asociadas a la asistencia sanitaria - la pandemia COVID-19 se presentó como un dato importante; en la seguridad para la cirugía, ya que agiliza el acceso al hospital para procedimientos quirúrgicos y, en la reducción de las colas de espera. También contribuye a la prevención de complicaciones derivadas de caídas, ya que el paciente puede ser ubicado rápidamente en una cama segura. Y, finalmente, el enfermero, en su papel de líder en el servicio, como enlace en la gestión del cuidado seguro, también resultó ser un resultado importante. Conclusión: aunque se detectaron algunas debilidades, se destaca la contribución del Núcleo Interno Normativo en el fortalecimiento de las metas de seguridad del paciente. Como resultado, reafirma la importancia de los flujos normativos desde la perspectiva de la gestión de camas hospitalarias, así como los preceptos de seguridad del paciente deseados por los gestores. Sin embargo, la enfermera actúa como enlace entre estos dos escenarios.(AU)

Preservation of phenolic compounds on dried leaf infusion of Bauhinia forficata Link

Abstract Bauhinia forficata Link aqueous extract is usually recommended as a phytomedicine to reduce blood glucose levels and its biological activity has been linked to the presence of phenolic compounds from B. forficata preparations. Several drying processes are used in the production of dry herbal extracts, which may influence the chemical composition and efficacy of final herbal medicines. Due to significant chemical changes, defining appropriate drying processes is essential for phytopharmaceutical drug development. In view of this, we analyzed dried B. forficata leaf infusion (BFLI) extracts by HPLC-UV-MSn, followed by molecular networking analysis to evaluate the chemical profiles from dried extracts yielded by freeze-and spray-drying processes. The main metabolites detected included 11 ferulic/isoferulic acid derivatives and 13 glycosylated flavonoids. The qualitative chemical profiles were alike for both drying processes, whereas the relative abundance of some flavonoids was higher using spray-drying. Taken together, our results showed that freeze-and spray-drying preserved the phenolic profile of BFLI and suggested that spray-drying may be the most suitable to obtain its dried products. Along with studying the chemical profiles of dried herbal extracts, evaluating the influence of drying processes on the quality and chemical profiles of final products is pivotal and may benefit future research.

Indicadores de qualidade para otimização da qualidade em farmácia hospitalar / Quality indicators for quality optimization in hospital pharmacy / Indicadores de calidad para la optimización de la calidad en farmacia hospitalaria

Objetivo: identificar, a partir de publicações científicas, indicadores de qualidade para a otimização da gestão em farmácia hospitalar. Método: revisão integrativa com levantamento bibliográfico nas bases de dados Scopus, Web of Science e Medline, entre 2019 e 2023, utilizando os descritores Patient Safety, Quality Indicators e Pharmacy Service. Foram incluídos documentos em português, inglês e espanhol, com os resumos disponíveis nas bases de dados selecionadas e disponíveis na íntegra sem custos. Para análise dos documentos, aplicou-se a ferramenta CASP adaptada. Resultados: foram identificados 15 documentos na Web of Science, 24 na Scopus e dois na Medline com a temática abordada no tópico. Conclusão: as ferramentas de gestão da qualidade mais frequentemente reportadas foram as relacionadas com a definição da causa raiz. Os indicadores de qualidade utilizados para monitorar os resultados foram, principalmente, satisfação da equipe de trabalho, tempo gasto na execução das atividades e redução de erros e custos.

Objective: to identify, from scientific publications, quality indicators for optimizing management in hospital pharmacy. Method:integrative review with bibliographic survey in the databases Scopus, Web of Science and Medline, between 2019 and 2023, using the descriptors Patient Safety, Quality Indicators and Pharmacy Service. Documents were included in Portuguese, English and Spanish, with abstracts available in the selected databases and available in full at no cost. The adapted CASP tool was used to analyze the documents. Results: 15 documents were identified in Web of Science, 24 in Scopus and two in Medline with the theme addressed in the topic. Conclusion: the most frequently reported quality management tools were those related to root cause definition. The quality indicators used to monitor the results were mainly satisfaction of the work team, time spent performing the activities, and reduction of errors and costs.

Objetivo: identificar, a partir de publicaciones científicas, indicadores de calidad para optimizar la gestión en farmacia hospitalaria.Método: revisión integrativa con levantamiento bibliográfico en las bases de datos Scopus, We of Science y Medline, entre 2019 y 2023, utilizando los descriptores Seguridad del Paciente, Indicadores de Calidad y Servicio de Farmacia. Se incluyeron documentos en portugués, inglés y español, con resúmenes disponibles en las bases de datos seleccionadas y disponibles en su totalidad sin costo. Para el análisis de los documentos se utilizó la herramienta CASP adaptada. Resultados: foram identificados 15 documentos na Web of Science, 24 na Scopus e dois na Medline com a temática abordada no tópico. Conclusión: las herramientas de gestión de la calidad más utilizadas fueron las relacionadas con la definición de la causa raíz. Los indicadores de calidad utilizados para monitorizar los resultados fueron principalmente la satisfacción del equipo de trabajo, el tiempo empleado en la realización de las actividades y la reducción de errores y costes.

Statistical process control of manufacturing tablets for antiretroviral therapy

Abstract In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular "Chopin Tavares de Lima" (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.

Development and validation of an analytical method by HPLC-DAD for determination of caffeine in products based on guarana extracts (Paullinia cupana)

Abstract Guarana (Paullinia cupana) is a native plant from the Amazon whose seeds contain a high concentration of caffeine. Aqueous extract of guarana is widely used in the world. In this study, the objective was to develop and validate a High-Performance Liquid Chromatography method for the determination of caffeine in extracts and commercial beverages based on guarana. A sensitive, simple, and viable high performance liquid chromatographic method without the need of an analyte extraction procedure was developed and validated according to Brazilian and international requirements. The method presented high performance, fulfilling Brazilian and international requirements, in addition to allowing product compliance tests. Results confirmed high selectivity and linearity (>0.999) between 5 to 135 ug/mL, with no significant matrix effect. Detection and quantification limits were 0.02 µg/mL and 2 µg/mL, respectively. Precision was less than 4 %, and accuracy varied from 99.9-120 %. Applicability of the method was demonstrated by conducting a limited evaluation in products containing caffeine. Commercial extracts showed quite different caffeine levels, while carbonated drinks follow Brazilian and American recommendations. Our results indicate that the developed method can be used to evaluate the quality of the guarana extract and of products containing caffeine

Chromatographic study of sitagliptin and ertugliflozin under quality-by-design paradigm

Abstract The present study entails the systematic development and validation of a stability-indicating RP-HPLC method for the analysis of sitagliptin and ertugliflozin in a fixed-dose combination. Analytical quality by design (AQbD) concepts were used to define critical method variables, employing Pareto risk assessment and a Placket-Burman screening design, preceded by a Box-Behnken design with response surface analysis to optimise critical method parameters such as % acetonitrile (X1), buffer pH (X2) and column oven temperature (X3). Multiple response optimisation (Derringer's desirability) of variables was accomplished by studying critical analytical attributes, such as resolution, retention time and theoretical plates. The title analytes were separated effectively on a PRONTOSIL C18 column at 37 °C using a mobile phase of acetonitrile:acetate buffer, pH 4.4 (36:64 percent v/v), pumped at a flow rate of 1 mL/min, and UV detection at 225 nm. Linearity was observed over a concentration range of 25-150 µg/mL and 3.75-22.5 µg/mL at retention times of 2.82 and 3.92 min for sitagliptin and ertugliflozin, respectively. The method obeyed all validation parameters of the ICH Q2(R1) guidelines. The proposed robust method allows the study of the selected drugs in pharmaceutical dosage forms as well as in drug stability studies under various stress conditions.

Além das curvas de crescimento: investigando o atendimento pediátrico e as práticas de puericultura na formação em residências médicas / Beyond growth curves: investigating service pediatric care and childcare practices in training in medical residencies

Este Trabalho de Conclusão de Curso (TCC) investiga a prática da puericultura e o atendimento pediátrico por residentes, com foco no aprendizado, confiança e atualizações dos profissionais, proporcionados pelos programas de residência médica. Os resultados revelam que a atualização é crucial para garantir a qualidade do atendimento, considerando as constantes evoluções na área pediátrica. Aspectos como crescimento, desenvolvimento neuropsicomotor, vacinação, diário alimentar e dinâmica familiar são fundamentais na consulta de puericultura e a conscientização sobre a importância da vacinação também é relevante. Promover programas de residência médica com formação teórica sólida e baseada em evidências científicas é essencial para o desenvolvimento de profissionais preparados para uma prática pediátrica de excelência, beneficiando diretamente a saúde das crianças e adolescentes atendidos. Palavras-chave: Medicina baseada em evidências. Puericultura. Hospitais de Ensino. Pediatria. Residência médica.