Construction and validation of an instrument for evaluating Lean Healthcare in healthcare institutions / Construcción y validación de un instrumento para evaluar el Lean Healthcare en instituciones de salud / Construção e validação de instrumento para avaliação do Lean Healthcare em instituições de saúde

ABSTRACT Objective: To build and validate an instrument to evaluate Lean Healthcare in healthcare institutions. Method: Methodological study conducted in three stages: 1) Instrument construction; 2) Content validity using the Delphi technique with 14 experts; and 3) Construct validation using Structural Equation Modeling with sample consisted of 113 professionals with experience in Lean Healthcare. Data collection carried out from October/2020 to January/2021 using a digital form. Data analysis performed with the SmartPLS2.0/M3 software. Results: Items were developed after an integrative review and divided into the dimensions Structure, Process and Outcome, according to Donabedian's theoretical framework. Content validation in two rounds of the Delphi technique. Final instrument, after model adjustment, containing 16 items with Cronbach's alpha of 0.77 in Structure, 0.71 in Process and 0.83 in Outcome. Conclusion: The instrument presented evidence of validity and reliability, enabling its use in healthcare institutions to evaluate Lean Healthcare.

RESUMEN Objetivo: Construir y validar un instrumento para evaluar Lean Healthcare en instituciones de salud. Método: Estudio metodológico realizado en tres etapas: 1) Construcción del instrumento; 2) Validez de contenido mediante técnica Delphi con participación de 14 expertos; 3) Validez de constructo mediante Modelado de Ecuaciones Estructurales con muestra compuesta por 113 profesionales con experiencia en Lean Healthcare. La recopilación de datos se realizó de octubre/2020 a enero/2021 mediante formulario digital. El análisis de datos se realizó con el software SmartPLS2.0/M3. Resultados: Ítems elaborados después de revisión integradora y divididos en las dimensiones Estructura, Proceso y Resultado, según referencial teórico de Donabedian. Validación de contenido en dos rondas de la técnica Delphi. Instrumento final, después del ajuste del modelo, contiene 16 ítems con alfa de Cronbach 0,77 en Estructura, 0,71 en Proceso y 0,83 en Resultado. Conclusión: El instrumento presentó evidencias de validez y confiabilidad, permitiendo uso para evaluar Lean Healthcare.

RESUMO Objetivo: Construir e validar um instrumento para avaliar o Lean Healthcare nas instituições de saúde. Método: Estudo metodológico realizado em três etapas: 1) Construção do instrumento; 2) Validade de conteúdo pela técnica Delphi com 14 especialistas; e 3) Validade de constructo por Modelagem de Equações Estruturais, em amostra de 113 profissionais com experiência no Lean Healthcare. Coleta de dados realizada de outubro/2020 a janeiro/2021 por formulário digital. Análise de dados realizadas com o software SmartPLS2.0/M3. Resultados: Itens elaborados após revisão integrativa e divididos nas dimensões Estrutura, Processo e Resultado, conforme referencial teórico de Donabedian. Validação de conteúdo em duas rodadas da técnica Delphi. Instrumento final, após ajuste do modelo, contendo 16 itens com alfa de Cronbach de 0,77 em Estrutura, 0,71 em Processo e 0,83 em Resultado. Conclusão: O instrumento apresentou evidências de validade e confiabilidade, permitindo seu uso nas instituições de saúde para avaliar o Lean Healthcare.

Protocolos gerenciados por enfermeiros para identificação precoce da sepse: revisão de escopo / Nurse-managed protocols for early identification of sepsis: a scoping review / Protocolos administrados por enfermeros para la identificación temprana de la sepsis: revisión del alcance

Objetivo: mapear os protocolos assistenciais utilizados por enfermeiros para identificação precoce da sepse no ambiente hospitalar. Método: trata-se de uma revisão de escopo ancorada nas recomendações do Joanna Briggs Institute, desenvolvida em sete bases de dados. A busca e seleção ocorreu em 17 de julho de 2021, utilizando os descritores: sepse, protocolos de enfermagem, avaliação de enfermagem e cuidados de enfermagem. Resultados: a amostra foi composta de seis estudos, destacaram-se os protocolos implementados por projetos de melhoria de qualidade e utilização sistemas eletrônicos de alerta para deterioração clínica. Conclusão: protocolos assistenciais impulsionam a aderência dos profissionais às recomendações oficiais para o manejo da sepse no ambiente hospitalar e o desenvolvimento de cuidados de enfermagem baseados em evidências, contribuindo para melhorar os indicadores de qualidade e reduzir a mortalidade entre pacientes com sepse.

Objective: to map the care protocols used by nurses for the early identification of sepsis in the hospital environment. Method: this is a scope review anchored in the recommendations of the Joanna Briggs Institute, developed in seven databases. The search and selection took place on July 17, 2021, using the descriptors: sepsis, nursing protocols, nursing assessment and nursing care. Results: the sample consisted of six studies, highlighting the protocols implemented by quality improvement projects and the use of electronic warning systems for clinical deterioration. Conclusion: care protocols boost professionals' adherence to official recommendations for the management of sepsis in the hospital environment and the development of evidence-based nursing care, contributing to improve quality indicators and reduce mortality among patients with sepsis.

Objetivo: mapear los protocolos de atención utilizados por las enfermeras para identificar de forma temprana la sepsis en el ambiente hospitalario. Método: se trata de una revisión de alcance anclada en las recomendaciones del Instituto Joanna Briggs, desarrollada en siete bases de datos. La búsqueda y selección se realizó el 17 de julio de 2021, utilizando los descriptores: sepsis, protocolos de enfermería, evaluación de enfermería y cuidados de enfermería. Resultados: la muestra estuvo compuesta por seis estudios, se destacaron los protocolos implementados por los proyectos de mejora de la calidad y utilización de sistemas electrónicos de alerta con respecto al deterioro clínico. Conclusión: los protocolos asistenciales impulsan la adherencia de los profesionales a las recomendaciones oficiales para el manejo de la sepsis en el ámbito hospitalario y el desarrollo de cuidados de enfermería basados en evidencias, contribuyendo a mejorar los indicadores de calidad y reducir la mortalidad entre los pacientes con sepsis.

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.

Applying Lean Healthcare in the hospitalization and patient discharge process: an integrative review / La aplicación de Lean Healthcare en el proceso de hospitalización y alta del paciente: revisión integrativa / A aplicação do Lean Healthcare no processo de hospitalização e alta do paciente: revisão integrativa

ABSTRACT Objectives: to identify scientific evidence regarding the use of Lean Healthcare approach in the hospitalization and patient discharge process. Methods: this is an Integrative Review conducted in the PubMed, LILACS, SCOPUS, CINAHL, Web of Science, and Embase databases. Results: out of 904 records identified, three were included in this review. The studies demonstrated that when applied to discharge planning, the Lean philosophy brings favorable results, promoting improvements in the communication process, as well as assisting in workflow organization, with a reduction in length of stay and improvement in the quality of care. Final Considerations: although the Lean methodology presents positive results, it is considered that the application of the philosophy in healthcare institutions is still not sustainable, as it is often restricted to specific departments or services. Thus, to maximize the success of implementation, the Lean philosophy needs to be incorporated into the organizational culture, representing the greatest challenge.

RESUMEN Objetivos: identificar evidencia científica sobre el uso del enfoque Lean Healthcare en el proceso de hospitalización y alta del paciente. Métodos: se realizó una revisión integrativa en las bases de datos PubMed, LILACS, SCOPUS, CINAHL, Web of Science y Embase. Resultados: de los 904 registros identificados, se incluyeron tres en esta revisión. Los estudios demostraron que, cuando se aplica en la planificación del alta, la filosofía Lean produce resultados favorables al mejorar la comunicación y ayudar a organizar el flujo de trabajo, reducir el tiempo de estancia y mejorar la calidad de la atención. Consideraciones Finales: aunque la metodología Lean muestra resultados positivos, su aplicación en las instituciones de salud no es sostenible, ya que a menudo se limita a algunos departamentos o servicios. Por lo tanto, para maximizar el éxito de la implementación, la filosofía Lean debe ser incorporada a la cultura organizacional, lo que representa el mayor desafio.

RESUMO Objetivos: identificar evidências científicas acerca da utilização do Lean Healthcare no processo de hospitalização e de alta do paciente. Métodos: trata-se de uma Revisão Integrativa realizada nas bases de dados PubMed, LILACS, SCOPUS, CINAHL, Web of Science e Embase. Resultados: dos 904 registros identificados, três foram incluídos nesta revisão. Os estudos demonstraram que, quando aplicada ao planejamento de alta, a filosofia Lean traz resultados favoráveis, promovendo melhorias no processo de comunicação, além de auxiliar na organização do fluxo de trabalho, com redução do tempo de permanência e melhoria na qualidade do cuidado. Considerações Finais: apesar da metodologia Lean apresentar resultados positivos, considera-se que sua aplicação nas instituições de saúde não é sustentável, uma vez que, na maioria das vezes, se restringe apenas a alguns setores e/ou serviços. Assim, para maximizar o sucesso da implementação, a filosofia Lean precisa ser incorporada à cultura organizacional, representando o maior desafio.

Content validation of an instrument for medical record audits / Validación de contenido de un instrumento para auditoría clínica de registros médicos / Validação de conteúdo de um instrumento para auditoria clínica de prontuários

ABSTRACT Objective: To build and validate the content of an instrument to conduct medical record audits; to conduct a pre-test. Methods: Methodological study conducted from May/2020 to May/2021 in three stages: 1) development of the instrument by bibliographic survey and benchmarking; 2) content validation using the Delphi technique; 3) application of the instrument and descriptive analysis in a sample of 200 medical records. Results: An instrument was constructed with 11 domains containing sub-items that characterize the quality of care. Two stages of the Delphi technique were necessary to reach a content validity index higher than 0.90. For each domain, a graduated scale with a numerical value from 1 to 4 points was attributed, reflecting the quality of its completion. The average time of application was 35 minutes per record. Conclusions: The tool proved to be viable to support clinical audits to identify the level of excellence and reveal opportunities for improvement in care processes.

RESUMEN Objetivo: Construir y validar contenido de un instrumento para realización de auditoría clínica de prontuarios; realizar pre-test. Métodos: Estudio metodológico, realizado de mayo/2020 a mayo/2021 en tres etapas: 1) construcción del instrumento por análisis bibliográfico y benchmarking; 2) validación de contenido por la técnica Delphi; 3) aplicación del instrumento y análisis descriptivo en una muestra de 200 prontuarios. Resultados: Construido un instrumento con 11 dominios conteniendo subitems que caracterizan la calidad de la asistencia. Para llegar al índice de validez de contenido superior a 0,90, fueron necesarias dos etapas de la técnica Delphi. Para cada dominio, atribuido una escala graduada con valor numérico de 1 a 4 puntos, reflejando la calidad del relleno. El tiempo mediano de aplicación fue de 35 minutos por prontuario. Conclusiones: El instrumento construido se demostró viable para basar la auditoría clínica en la identificación del nivel de excelencia o oportunidades de mejoría en procesos asistenciales.

RESUMO Objetivo: Construir e validar conteúdo de um instrumento para realização de auditoria clínica de prontuários; realizar pré-teste. Métodos: Estudo metodológico, realizado de maio/2020 a maio/2021 em três etapas: 1) construção do instrumento por levantamento bibliográfico e benchmarking; 2) validação de conteúdo pela técnica Delphi; 3) aplicação do instrumento e análise descritiva em uma amostra de 200 prontuários. Resultados: Construiu-se um instrumento com 11 domínios contendo subitens que caracterizam a qualidade da assistência. Para chegar ao índice de validade de conteúdo superior a 0,90, foram necessárias duas etapas da técnica Delphi. Para cada domínio, atribuiu-se uma escala graduada com valor numérico de 1 a 4 pontos, refletindo a qualidade do preenchimento. O tempo médio de aplicação foi de 35 minutos por prontuário. Conclusões: O instrumento construído demonstrou-se viável para embasar a auditoria clínica na identificação do nível de excelência ou oportunidades de melhoria em processos assistenciais.

Lean methodology implementation in the emergency department of a university hospital: management and sustainable development / Implantación de la metodología lean en el servicio de urgencias de un hospital universitario: gestión y desarrollo sostenible / Implementação da metodologia lean na emergência de um hospital universitário: gestão e desenvolvimento sustentável

ABSTRACT Objective: to describe the implementation of the Lean Methodology in an emergency department and its contribution to sustainable and quality management. Method: this is a methodological study carried out between October 2018 and January 2022 in the adult emergency department of a public university hospital in southern Brazil, analyzing the results before and after the implementation of the Lean Methodology. The study followed the model and standards adopted by the Standards for Quality Improvement Reporting Excellence 2.0 (SQUIRE) for the description of improvement cycle standards. Results: with the implementation of this methodology, actions were developed, such as innovations in work routines, both care and management, changes in patient reception with risk classification, construction of units for patient care and allocation, daily interdisciplinary meetings (huddle), full contingency plan, hospital discharge routines, external transfers, changes in the communication process with users and professionals, among other actions. Conclusion: the use of the Lean Methodology has resulted in a reduction in occupancy, which has helped to optimize health resources and ensure quality care and management practices. This reduction is believed to be proof of sustainable management in health services and contributes to reducing socio-economic inequalities.

RESUMEN Objetivo: describir la aplicación de la Metodología Lean en un servicio de urgencias y su contribución a una gestión sostenible y de calidad. Método: se trata de un estudio metodológico realizado entre octubre de 2018 y enero de 2022 en el servicio de urgencias de adultos de un hospital universitario público del sur de Brasil, analizando los resultados antes y después de la implementación de la Metodología Lean. El estudio siguió el modelo y las normas adoptadas por el Standards for Quality Improvement Reporting Excellence 2.0 (SQUIRE) para describir las normas de los ciclos de mejora. Resultados: con la implementación de esta metodología, se desarrollaron acciones como innovaciones en las rutinas de trabajo, tanto asistenciales como de gestión, cambios en la recepción con clasificación de riesgo, construcción de unidades de atención y asignación de pacientes, reuniones interdisciplinarias diarias (huddle), plan de contingencia completo, rutinas de alta hospitalaria, traslados externos, cambios en el proceso de comunicación con usuarios y profesionales, entre otras acciones. Conclusión: la utilización de la Metodología Lean ha dado lugar a una reducción de los efectivos, lo que ha permitido optimizar los recursos de atención sanitaria y garantizar prácticas asistenciales y de gestión de calidad. Se considera que esta reducción es una prueba de gestión sostenible en los servicios de salud y contribuye a reducir las desigualdades socioeconómicas.

RESUMO Objetivo: Descrever a implementação da Metodologia Lean em um serviço de emergência, e a contribuição para uma gestão sustentável e de qualidade. Método: Trata-se de estudo metodológico, realizado entre outubro de 2018 a janeiro de 2022, no serviço de emergência adulto de um hospital público universitário no Sul do Brasil, com análise de resultados antes e após a implementação da Metodologia Lean. O estudo seguiu o modelo e as normas adotadas pelo Standards for Quality Improvement Reporting Excellence 2.0 (SQUIRE) para a descrição dos padrões dos ciclos de melhoria. Resultados: Com a implementação desta metodologia, foram desenvolvidas ações, como inovações nas rotinas de trabalho, tanto assistenciais como gerenciais, mudanças no acolhimento com classificação de risco, construção de unidades para atendimento e alocação de pacientes, reuniões diárias interdisciplinares (huddle), plano de contingência pleno, rotinas de altas hospitalares, transferências externas, mudança no processo de comunicação com usuários e profissionais, dentre outras ações. Conclusão: A utilização da Metodologia Lean resultou na diminuição da lotação e com isto pode-se otimizar recursos de saúde e assegurar práticas assistenciais e gerenciais de qualidade. Acredita-se que esta diminuição seja a comprovação de uma gestão sustentável em serviços de saúde e colabora para a redução de desigualdades socioeconômicas.

Gestión de calidad como herramienta en la evaluación del desempeño organizacional en la universidad médica / Quality management as a tool in the evaluation of organizational performance in the medical university

Fundamento: en el contexto de las instituciones de educación superior, el desempeño organizacional cobra relevancia debido al papel fundamental que estas organizaciones tienen en la formación de capital humano. Su vínculo con la calidad subyace en el mejoramiento organizacional, científico e intelectual. Objetivo: fundamentar la aplicación de herramientas derivadas de los sistemas de gestión de calidad en la evaluación del desempeño organizacional desde el componente científico-investigativo. Métodos: se realizó un estudio descriptivo en la Universidad de Ciencias Médicas de Matanzas, en el periodo 2018-2020. Se aplicaron métodos teóricos para la fundamentación de la investigación, y empíricos: revisión documental de informes de trabajo y el análisis de indicadores de desempeño organizacional. Resultados: el diagnóstico reveló no conformidades asociadas a la eficiencia y eficacia de los procesos académicos, el trabajo científico-metodológico, y los mecanismos de análisis, medición y mejora del funcionamiento del componente científico-investigativo. Consecuentemente se puntualizaron como oportunidades de investigación, el diseño de instrumentos para evaluar el desempeño con la integración de herramientas como las auditorías y los costos de calidad. Conclusiones: el estudio reveló la oportunidad y valor científico de abordar la gestión del desempeño científico-investigativo de la universidad médica, basado en herramientas de gestión de la calidad.

Background: in the context of higher education institutions, organizational performance becomes relevant due to the fundamental role that these organizations have in the formation of human capital. Its link with quality underlies organizational, scientific and intellectual improvement. Objective: to base the application of tools derived from quality management systems in the evaluation of organizational performance from the scientific-researcing component. Methods: a descriptive study was carried out at Matanzas University of Medical Sciences, from 2018 to 2020. Theoretical methods were applied for the foundation of the investigation, and empirical ones: documentary review of work reports and the analysis of organizational performance indicators. Results: the diagnosis revealed non-conformities associated with the efficiency and effectiveness of the academic processes, the scientific-methodological work, and the mechanisms for analysis, measurement, and improvement of the functioning of the scientific-researching component. Consequently, the design of instruments to evaluate performance with the integration of tools such as audits and quality costs were pointed out as research opportunities. Conclusions: the study revealed the opportunity and scientific value of addressing the scientific-researching performance management of the medical university, based on quality management tools.

SWOT analysis to reduce surgical center idleness and increase revenue in a hospital

ABSTRACT Objective To reduce surgical center idleness by analyzing the competitive structure of the surgical center in a hospital, and thereby generate value in operations and increase hospital revenue. Methods The study used qualitative and quantitative methods and an action research approach involving the surgical center leadership of a small private specialized hospital in southeastern Brazil. We used the Strengths, Weaknesses, Opportunities, and Threats or SWOT tool to analyze the competitive structure of the surgical center and then implemented interventions as proposed by the science of improvement method proposed by the Institute of Healthcare Improvement. Results By applying the SWOT tool, we identified a concentration of surgeries in the specialty of Otolaryngology and the need to establish a health management system to reduce the idleness of the operating rooms. Based on subsequent intervention, procedures from other specialties were inserted that increased surgical production by 2.62X, reduced idleness by 67.84%, and increased revenue by over US$ 276,609.87 in 2018 compared to the previous year 2017. Conclusion Investing in quality, surgical schedule management, and inducting new surgeons to the clinical staff resulted in decreased surgical idleness, increased production, better uniformity in scheduling, and increased revenue, while costs remained below the linear trend, allowing for increased profits.

Lean Six Sigma methodology to improve the discharge process in a Brazilian intensive care unit / Metodologia Lean Seis Sigma para melhoria do processo de alta em uma unidade de terapia intensiva / Metodología Lean Six Sigma para mejorar el proceso de alta en una unidad de cuidados intensivos

ABSTRACT Objectives: to describe the Lean Six Sigma implementation process to improve the discharge process in a Brazilian health institution's ICU. Methods: prospective study following the Define-Measure-Analyse-Improve-Control project development method. This method consists of five phases, namely: project definition, measurement of the starting point and data collection, analysis of results, improvement in processes, and statistical control. Results: applying Lean Six Sigma methodology following the Define-Measure-Analyse-Improve-Control in the discharge process from the intensive care unit to the inpatient unit was effective in improving processes. This improvement represented a reduction in the mean patient transfer time to the inpatient unit from 189 minutes to 75 minutes, representing a 61% improvement in discharge time. Conclusions: this article demonstrates the effectiveness of applying Lean Six Sigma methodology to improve the discharge flow in a critical unit, resulting in time and waste reduction.

RESUMO Objetivos: descrever o processo de implementação do Lean Seis Sigma para melhoria do processo de alta em uma unidade de terapia intensiva brasileira. Método: foi realizado um estudo prospectivo, que seguiu o método de desenvolvimento de projetos intitulado DMAIC (Define-Measure-Analyze-Improve-Control). Este método constituiu cinco fases, sendo elas: a definição do projeto, mensuração do ponto inicial e coleta de dados, análise dos resultados, melhoria dos processos e controle estatístico. Resultados: a aplicação da metodologia Lean Seis Sigma foi efetiva para melhoria do processo de alta da unidade de terapia intensiva para a unidade de internação. Esta melhoria representou uma redução no tempo médio de alta de 189 para 75 minutos, totalizando uma melhoria de 61%. Conclusões: este artigo demonstra a efetividade da aplicação da metodologia Lean Seis Sigma para melhoria do fluxo de alta em uma unidade crítica, possibilitando ganhos na redução de tempo e desperdícios.

RESUMEN Objetivos: describir el proceso de implementación de Lean Six Sigma para mejorar el proceso de alta en una unidad de cuidados intensivos brasileña. Métodos: estudio prospectivo siguiendo el método de desarrollo de proyectos denominado DMAIC (Define-Measure-Analyze-Improve-Control). Este método consta de cinco fases, a saber: definición del proyecto, medición del punto de partida y recolección de datos, análisis de resultados, mejora en los procesos y control estadístico. Resultados: la aplicación de la metodología Lean Six Sigma fue efectiva para mejorar el proceso de alta de la unidad de cuidados intensivos a la unidad de hospitalización. Esta mejora representó una reducción en el tiempo promedio de alta de 189 a 75 minutos, totalizando una mejora del 61%. Conclusiones: este artículo demuestra la efectividad de la aplicación de la metodología Lean Six Sigma para mejorar el flujo de descarga en una unidad crítica, lo que resulta en la reducción de tiempo y desperdicio.

Construction and application of total quality management system in pharmacy intravenous admixture service / 中国药房

OBJECTIVE To establish a total quality management system for pharmacy intravenous admixture services （PIVAS）， in order to promote the standardization， accuracy and rationalization of clinical intravenous infusion. METHODS Based on information system in PIVAS， the management system and quality monitoring items of the whole process before， during and after PIVAS infusion preparation were formulated. The quality control and quality improvement were carried out regularly with quality management tools and methods such as PDCA （plan， do， check， process） cycle， quality control circle， and root cause analysis. The main quality control indexes of PIVAS were retrospectively analyzed before （in 2019） and after PDCA cycle management （in 2020 and 2021）. RESULTS The indexes of quality monitoring in the whole process of PIVAS infusion preparation， such as the score of drug quality management， the drug residue qualification rate and the qualified rate of drug content in infusion， were increased from 92 points， 79%， 86.4% in 2019 to 99 points， 92%， 99.8% in 2021， respectively. The indexes of safe and rational drug use， such as the ratio of intravenous irrational medical orders， the rate of drug repercussion， the rate of antibiotics use， and the rate of TCM injection use decreased from 0.98%， 6.1%， 40.55%， 39.70% to 0.23%， 3.2%， 37.18%， 26.00%， respectively. CONCLUSIONS The established total quality management system for PIVAS can improve the quality management level in the infusion preparation process， improve the quality of infusion preparation and promote clinical safe and rational drug use.

Analysis on the results of external quality assessment for quality indicators of clinical laboratory in China / 中华医院管理杂志

Objective:To analyze the implementation of the external quality assessment plan for quality indicators of clinical laboratories in China from 2016 to 2021, as well as that of the external quality assessment of 15 quality indicators in clinical laboratories, in order to provide reference for quality management of clinical laboratory specialties.Methods:The research data was collected from the external quality assessment plan for quality indicators, which was conducted by the National Center for Clinical Laboratories joining the clinical laboratory centers of 31 provinces (autonomous regions and municipalities directly). The essential information reported by each participating clinical laboratory from 2016 to 2021 and the external quality assessment data of 15 quality indicators in clinical laboratories were collected, followed by a descriptive analysis on the number of participating laboratories and the number of returns for each indicator. Median representation was used for the external quality assessment data of 15 quality indicators in clinical laboratories, and the TOPSIS method was applied to comprehensively evaluate the quality of the total testing process of participating clinical laboratories in each year.Results:From 2016 to 2021, the number of laboratories participating in the external quality assessment plan for quality indicators of clinical laboratory increased from 7 704 to 12 142. Quality indicators in pre-analytical phases: the incorrect sample type rate, incorrect sample container rater, and incorrect fill level rate had been decreasing year by year, reaching 0, 0, and 0.005 8% in 2021, respectively. The anticoagulant samples clotted rate had decreased from 0.068 6% in 2016 to 0.042 8% in 2021, and the blood culture contamination rate from 2017 to 2021 had been 0 without exception. The pre-examination turnaround time had been shortened from 28 minutes in 2016 to 2019 to 24 minutes in 2020 and 2021. Quality indicators in analytical phases: the intra-laboratory turnaround time had been extended from 45 minutes in 2016 to 2019 to 50 minutes in 2020 and 2021. Test covered by an IQC rate had been increasing year by year, reaching 60.61% in 2021. Test with inappropriate IQC performances rate was 0 in 2020 and 2021, the test covered by an EQA-PT control rate was 100%, and unacceptable performances in EQA-PT schemes rate from 2017 to 2021 was 0. The inter-laboratory comparison rate had increased from 1.56% in 2016 to 3.00% in 2021. Quality indicators in post-analytical phases: the incorrect laboratory reports rate, critical values notification rate and timely critical values notification rate had been 0, 100%, and 100%from 2016 to 2021 respectively. The comprehensive evaluation results of TOPSIS method showed that the overall quality level of clinical laboratory testing in 2020 was the highest, with Ci value of 0.850 5, while the lowest Ci value in 2016 was 0.143 6. Conclusions:The quality of clinical laboratory testing in China has been effectively improved. Clinical laboratories should continue to strengthen their monitoring of quality indicators, especially the intra-laboratory turnover time and the inter-laboratory comparison rate, for the purposes of identifying errors, analyzing causes and taking corrective measures to improve quality.

Panorama da acreditação (inter)nacional no Brasil / Panorama de la acreditación (inter) nacional en Brasil / Overview of (inter)national accreditation in Brazil

RESUMO Objetivo delinear o panorama da Acreditação nacional e internacional no Brasil. Método estudo descritivo, de abordagem quantitativa e fonte documental. Os campos de inquérito foram as páginas online de acesso irrestrito das seguintes metodologias acreditadoras: Organização Nacional de Acreditação (ONA), Joint Commission International (JCI), Accreditation Canada International (ACI) e QMentum Internacional, além da página do Cadastro Nacional de Estabelecimentos de Saúde (CNES) e/ou sites institucionais. Foram extraídas as variáveis: tipo de instituição/estabelecimento de saúde; regime de gestão setorial; localidade; nível de certificação (em caso de selo concedido pela ONA) e porte (para hospitais). Empregou-se análise estatística descritiva. Resultados apuraram-se os dados de 1.122 certificações, especialmente da ONA (77,2%) e QMentum International (13,2%). Os hospitais prevaleceram na adesão à Acreditação (35,3%), principalmente os de grande porte (60,3%) e do setor privado (75,8%). Houve concentração dos selos de qualidade na região Sudeste do Brasil (64,5%), e a região Norte apresentou menor proporção de estabelecimentos certificados (3%). Conclusões e implicações para a prática as certificações de Acreditação no Brasil remetem à metodologia nacional, com enfoque na área hospitalar privada e na região Sudeste do país. O mapeamento delineado pode sustentar assertividade em políticas de incentivo à gestão da qualidade e avaliação externa no Brasil.

RESUMEN Objetivo delinear el panorama de la Acreditación nacional e internacional en Brasil. Método estudio descriptivo, con enfoque cuantitativo y fuente documental. Los campos de consulta fueron las páginas en línea de libre acceso de las siguientes metodologías de acreditación: Organización Nacional de Acreditación (ONA), Joint Commission International (JCI), Accreditation Canada International (ACI) y QMentum Internacional, además del Registro Nacional de Establecimientos Salud (CNES) y/o sitios web institucionales. Se extrajeron las variables: tipo de institución/establecimiento de salud; régimen de gestión sectorial; localidad; nivel de certificación (en caso de sello otorgado por la ONA) y tamaño (para hospitales). Se utilizó análisis estadístico descriptivo. Resultados se recogieron datos de 1.122 certificaciones, especialmente de ONA (77,2%) y QMentum International (13,2%). Los hospitales prevalecieron en la adhesión a la Acreditación (35,3%), en especial los hospitales grandes (60,3%) y el sector privado (75,8%). Hubo concentración de sellos de calidad en la región Sudeste de Brasil (64,5%), y la región Norte tuvo la menor proporción de establecimientos certificados (3%). Conclusiones e implicaciones para la práctica las certificaciones de acreditación en Brasil se refieren a la metodología nacional, con foco en el área hospitalaria privada y la región Sudeste del país. El mapeo esbozado puede apoyar la asertividad en las políticas de fomento de la gestión de la calidad y la evaluación externa en Brasil.

ABSTRACT Objective to outline the panorama of national and international Accreditation in Brazil. Method a descriptive study, of quantitative approach and documental source. The survey fields were the unrestricted access online pages of the following accrediting methodologies: National Accreditation Organization (ONA), Joint Commission International (JCI), Accreditation Canada International (ACI), and QMentum International, besides the page of the National Registry of Health Establishments (CNES) and/or institutional sites. Variables were extracted: type of institution/health care facility; sector management regime; location; level of certification (in case of a seal granted by ONA), and size (for hospitals). Descriptive statistical analysis was used. Results data from 1,122 certifications was obtained, especially from ONA (77.2%) and QMentum International (13.2%). Hospitals prevailed in the Accreditation adherence (35.3%), mainly the large ones (60.3%) and from the private sector (75.8%). There was a concentration of quality seals in the Southeast region of Brazil (64.5%), and the North region presented the lowest proportion of certified establishments (3%). Conclusions and implications for practice the Accreditation certifications in Brazil refer to the national methodology, focusing on the private hospital area and the Southeast region of the country. The mapping outlined can support assertiveness in incentive policies for quality management and external evaluation in Brazil.

Process-based Management aimed at improving health care and financial results / Gestión basada en procesos visando a mejoría de los resultados asistenciales y financieros en Salud / Gestão baseada em processos visando à melhoria dos resultados assistenciais e financeiros em Saúde

ABSTRACT The limited resources allocated to the health area and the growing demands require leaders' qualified and committed performance in hospital management. In this perspective, the objective of this study is to reflect on the management practices that can be applied to hospital facilities to achieve better care and financial results. Among them, process-based management proposes an approach for continuous process improvement to achieve desired results; the method Lean Six Sigma allows identifying and eliminating waste in production processes; the continuous improvement model combines practical knowledge with the knowledge of how the system to be improved works, through observations and changes that allow its results measurement; and cost management and value-based healthcare provides for care mapping, from beginning to end, to assess what actually adds value to patients. The contributions of implementing these practices are recognized worldwide; using them, processes can be increased, improving efficiency, reducing waste, adding value to the business, increasing its revenue, and resulting in savings that can be passed on to the consumer, by improving quality.

RESUMEN Los recursos limitados destinados al área de Salud y las crecientes demandas exigen la actuación calificada y comprometida de líderes en la gestión hospitalaria. En esta perspectiva, el objetivo es reflexionar sobre las prácticas de gestión que se pueden aplicar a las instituciones hospitalarias para lograr mejores resultados asistenciales y económicos. Entre ellos, la gestión basada en procesos propone un enfoque de mejora continua de procesos para lograr los resultados deseados; el método Lean Six Sigma permite identificar y eliminar los desperdicios en los procesos productivos; el modelo de mejoría continua combina el conocimiento práctico al conocimiento del funcionamiento del sistema que se reta mejorar, a través de observaciones y cambios que permitan la medición de sus resultados; y la gestión de costes y de salud atención médica basada en el valor establece que la atención sea mapeada, desde el principio hasta el final del proceso, para evaluar lo que efectivamente es lo que agrega valor a los pacientes. Las contribuciones de implementación de esas prácticas son reconocidas a nivel mundial; con ellas se pueden incrementar los procesos, aumentando la eficiencia, reduciendo los desperdicios, agregando valor al negocio, aumentando sus ingresos y generando ahorros que pueden transferirse al consumidor, al mejorar la calidad.

RESUMO Os recursos limitados destinados à área da Saúde e as demandas crescentes requerem a atuação qualificada e compromissada dos líderes na gestão hospitalar. Nesta perspectiva, objetiva-se refletir sobre as práticas de gestão passíveis de serem aplicadas às instituições hospitalares visando o alcance de melhores resultados assistenciais e financeiros. Dentre elas, a gestão baseada em processos propõe uma abordagem para melhoria contínua dos processos a fim de alcançar os resultados desejados; o método Lean Six Sigma permite identificar e eliminar desperdícios nos processos produtivos; o modelo de melhoria contínua alia o conhecimento prático ao conhecimento do funcionamento do sistema a ser melhorado, por meio de observações e mudanças que permitam a mensuração de seus resultados; e a gestão de custos e a Saúde baseada em valor preveem que o cuidado seja mapeado, do início ao fim do processo, para avaliar o que, de fato, agrega valor aos pacientes. As contribuições da implementação dessas práticas são reconhecidas mundialmente; utilizando-as, os processos podem ser incrementados, aumentando a eficiência, reduzindo os desperdícios, agregando valor ao negócio, aumentando a sua receita e resultando em economias que podem ser repassadas ao consumidor, pela melhoria da qualidade.

Effectiveness of implementing an improvement cycle in the identification of critically ill patients / Efectividad de la implantación de un ciclo de mejoría en la identificación del paciente crítico / Efetividade da implantação de um ciclo de melhoria na identificação do paciente crítico

ABSTRACT Objective: To evaluate the effectiveness of implementing a quality improvement cycle in the process for identifying critically ill patients in an intensive care center. Methods: The implementation of an observational and interventional improvement cycle, using a before-and-after quasi-experimental design, with a quantitative approach, in an intensive care center. Seven criteria were developed to evaluate the quality of the identification process. The results of the intervention were subjected to statistical analysis. Results: The quality of the identification process showed significant improvement in the values referring to compliance with the conformities in the criteria evaluated. Statistical significance was observed in the evaluations of criteria C1, C2, C3, C4, and C6, with increased compliance values after the intervention. Final considerations: The efficacy of the improvement cycle in the quality of the patient identification process was evidenced. It was possible to involve and encourage the participation of the care team and improve organizational processes.

RESUMEN Objetivo: Evaluar efectividad de implantación de un ciclo de mejoría de calidad en el proceso de identificación del paciente crítico en un centro de cuidados intensivos. Métodos: Implementación de ciclo de mejoría, observacional e intervención, utilizando diseño cuasi-experimental, antes y después, con abordaje cuantitativo, en un centro de cuidados intensivos. Elaborados siete criterios para evaluación de calidad del proceso de identificación. Los resultados de la intervención fueron sometidos al análisis estadístico. Resultados: La calidad del proceso de identificación presentó mejoría significativa en los valores referentes al cumplimiento de las conformidades en los criterios evaluados. Observada significación estadística en las evaluaciones de los criterios C1, C2, C3, C4 y C6, con aumento en los valores de cumplimiento posintervención. Consideraciones finales: Evidenciado la eficacia del ciclo de mejoría en la calidad del proceso de identificación del paciente. Fue posible involucrar y estimular la participación del equipo asistencial y mejorar los procesos organizacionales.

RESUMO Objetivo: Avaliar a efetividade da implantação de um ciclo de melhoria da qualidade no processo de identificação do paciente crítico em um centro de cuidados intensivos. Métodos: Trata-se da implementação de ciclo de melhoria, observacional e de intervenção, utilizando desenho quase experimental, antes e depois, com abordagem quantitativa, em um centro de cuidados intensivos. Foram elaborados sete critérios para avaliação da qualidade do processo de identificação. Os resultados da intervenção foram submetidos à análise estatística. Resultados: A qualidade do processo de identificação apresentou melhoria significativa nos valores referentes ao cumprimento das conformidades nos critérios avaliados. Foi observada significância estatística nas avaliações dos critérios C1, C2, C3, C4 e C6, com aumento nos valores de cumprimento após a intervenção. Considerações finais: Evidenciou-se a eficácia do ciclo de melhoria na qualidade do processo de identificação do paciente. Foi possível envolver e estimular a participação da equipe assistencial e melhorar os processos organizacionais.

Exploration and practice of multiple campuses of one hospital for public hospitals / 中华医院管理杂志

The construction of multiple campuses of one public hospital is an effective way to enlarge supply of high-quality medical resources. On the basis of sorting out the key and difficult problems faced in " multiple campuses" , People′s Hospital of Zhengzhou took " integrated management, homogeneous service, joint logistics support, and high quality development" as the main goal. It followed the guidelines of " Party committee taking overall charge, headquarters taking charge of building, campuses taking charge of routine operations, and orchestrated logistics support" . The hospital took the tactics of " collaborative oriented homogenization management" and " demand oriented and differentiated hospital positioning and discipline layout" . The practice and effect of the hospital included building multiple campuses in terms of management system, medical quality system, outstanding service system, personnel management system, cost management system, cultural construction system, and information management system. By such measures, the hospital has scientifically determined its orientation and discipline layout of every campus, hence offering references for the establishment and management model of " multiple campuses" at public hospitals at large.

Quality management of helicopter emergency medical service for critically ill patients / 中国基层医药

Public health emergencies have occurred frequently in recent years, with the characteristics of difficult rescue and a complex environment. Helicopter emergency medical service is an effective way to deal with catastrophic events. The service can effectively shorten the transfer time taken for patient transfer between hospitals, directly send patients to the hospitals that meet requirements for clinical treatment, and avoid the possible delayed treatment caused by a secondary transfer. Helicopter emergency medical service in China is still in its infancy, and there are various problems in the actual operation. Strict whole process quality management is needed to achieve the expected outcome. The paper reviews the current situation of helicopter rescue for critically ill patients in China and suggests a set of quality management schemes (including base construction, rescue equipment allocation, rescue personnel selection, rescue system construction, and on-site rescue procedure standardization). Findings from this paper hope to provide evidence for the development of aviation rescue in China. This study is innovative and scientific.

Discussions on risk-based quality management of investigator initiated trials / 中华医院管理杂志

Effective supervision of the clinical research management department can guarantee and improve the quality of the investigator initiated trials(IIT). The authors analyzed relevant clinical research regulations and literature and summarized the current situation of risk-based IIT project process quality management. On such basis, they determined the risk-based IIT project process quality management method in combination with the previous research of the research group.From 2021 to 2022, this method was used to implement process quality management for 353 IIT projects in Shanghai′s tertiary hospitals. More than 3 000 risk points were identified through centralized supervision, and then on-site supervision was carried out to correct the problems found. As proven by the results, the method could find existing problems in time and define the risk level of the project, and also formulate an individualized risk supervision plan accordingly, so as to effectively ensure the data reliability and scientific results. It is suggested that the clinical research management department implement risk based management for the whole process of IIT projects, increase funding and staffing, and implement hierarchical management for the projects by research types, so as to promote the sustainable development of IITs.

Discussions on the quality control system of investigator initiated trials in the new circumstances / 中华医院管理杂志

China is stepping up its standardized management of investigator initiated trials(IIT)carried out by medical and health institutions, spotlighting the establishment and improvement of the quality control system of IIT projects than ever before. The authors retrieved official websites of clinical research related units of medical institutions and research institutes at home and abroad, and by means of literature review analyzed the current quality management of IIT projects at home and abroad. They found such setbacks as lack of quality management standards and norms, imperfect quality control mechanism, poor awareness of quality risk, insufficient quality supervision and poor quality control ability of clinical researchers. Based on the above, the paper made the following recommendations for building an IIT project quality control system in China: developing quality management standards and norms, setting up a systematic quality control mechanism(i.e., exploring a three-level quality control mode composed of the project team/department-hospital-national supervision institution/peer review expert team, and implementing the whole process quality control mechanism), strengthening policy guidance and system construction, and strengthening the standardized training of clinical researchers.

CHINA PH ARMACY Volume 33，Number 12，June 30，2022 Semimonthly Table of Contents Construction of total q uality managemen t system of clinica l comprehens ive evaluation of drugs in China / 中国药房

OBJECTIVE To provide reference for scientifi c and standardized development of clinical comprehensive evaluation of drugs in China. METHODS Guided by the theory of total quality management （TQM），drawing lessons from the successful experience of the British and German conducting evaluation ，combining with plan-do-check-act cycle and other quality management methods and tools ，drug clinical comprehensive evaluation of total quality management system was constructed in accordance with the requirements for our country related policy and local practice. RESULTS & CONCLUSIONS To construct total quality management system of clinical comprehensive evaluation of drugs in China from 5 aspects of organization system ，management process，assessment system ，evaluation and supervision platform ，support and guarantee mechanism. The organization system included national ，provincial and medical institutions ；management process should focus on the key links in the 3 stages of theme selection，evaluation and implementation ，and result transformation and application ；assessment system ，evaluation and supervision platform，support and guarantee mechanism should be established together so as to further improve the scientificity ，rationality， practicality and standardization of total quality management of clinical comprehensive evaluation of drugs. The development of total quality management is an effective starting point to promote the continual improvement of the drug clinical comprehensive evaluation；relevant government departments and the implementation of evaluation of medical institutions should further set up quality management consciousness ，establish report quality feedback mechanism and the results co-constructing and sharing mechanism and strengthen professional personnel training and innovation synergy regulation mode to ensure that the authenticity and reliability of evaluation results.