Efectos de la COVID-19 en la calidad de la atención de los servicios de salud en Colombia: Revisión de literatura / Effects of COVID-19 on the quality of health care services in Colombia: a literature review / Efeitos da covid-19 na qualidade dos serviços de saúde na colômbia: revisão da literatura

Introducción: La pandemia por COVID-19 ha afectado significativamente la calidad de los servicios de cuidado de la salud. Objetivo: Analizar los efectos en los atributos de la calidad en salud de los servicios de atención de enfermedades diferentes a la COVID-19 en Colombia, durante el periodo 2020-2022. Materiales y métodos: Se analizaron 24 artículos de alcance nacional y otros específicos de departamentos como Antioquia, Córdoba, Santander y Cundinamarca. Resultados: La pandemia por COVID-19 impactó la calidad de los servicios en la atención de enfermedades como cáncer, accidentes cerebrovasculares y de eventos como la interrupción voluntaria del embarazo. Conclusión: La calidad de la salud se vio afectada en todas sus dimensiones durante las fases de la pandemia, especialmente en la población con enfermedades crónicas y relacionadas con la salud infantil y materna. Además, se destacaron respuestas como el uso de la telemedicina y de la atención domiciliaria para contribuir a la calidad de la salud en Colombia.

Introduction: The COVID-19 pandemic has significantly affected the quality of health care services. Objective: To analyze the effects of COVID-19 on the quality of health care services focused on treating diseases other than COVID-19 in Colombia during the 2020-2022 period. Materials and methods: 24 articles were analyzed, which included some studies focused on national issues and others specific to the departments of Antioquia, Cordoba, Santander, and Cundinamarca. Results: The COVID-19 pandemic affected the quality of health services caring for diseases such as cancer, strokes, and critical circumstances like voluntary termination of pregnancy. Conclusion: All dimensions of health care were affected during the pandemic, especially impacting populations with chronic diseases and diseases related to child and maternal health. It is important to highlight that telemedicine and home care contributed to improving the quality of health in Colombia.

Introdução: A pandemia de COVID-19 afetou significativamente a qualidade dos serviços de saúde. Objetivo: Analisar os efeitos da COVID-19 nos atributos de qualidade em saúde dos serviços de atenção a outras doenças além da COVID-19 na Colômbia, durante o período 2020-2022. Materiais e métodos: foram analisados 24 artigos de âmbito nacional e outros específicos de departamentos como Antioquia, Córdoba, Santander e Cundinamarca. Resultados: A pandemia da COVID-19 impactou a qualidade dos serviços no cuidado de doenças como câncer, acidente vascular cerebral e eventos como a interrupção voluntária da gravidez. Conclusão: A qualidade da saúde foi afetada em todas as suas dimensões durante as fases da pandemia, especialmente na população com doenças crônicas e doenças relacionadas à saúde infantil e materna. Além disso, foram destacadas respostas como o uso da telemedicina e do atendimento domiciliar para contribuir para a qualidade da saúde na Colômbia.

Progress in quality management and control of donor organ procurement in foreign countries / 器官移植

Since the 20th century, organ transplantation has become a breakthrough technology to effectively save the lives of patients with end-stage organ failure, which has significantly enhanced the quality of life of patients. Organ donation is an important source of organ transplantation. Improving the quality of donor organ procurement is the key to promote the translation of donor organs and improve the prognosis of organ transplantation recipients. The United States, Spain and other countries have put forward a series of policies and standards in the quality management and control of donor organ procurement and achieved positive results. In this article, related concepts of medical quality management and control, advanced strategies and models of international donor organ procurement quality management, and quality control measures of Organ Procurement Organization, donors and donor organs were reviewed, aiming to provide reference for establishing a quality management and control system of donor organs with "Chinese characteristics" and advancing high-speed and high-quality development of donor organ procurement.

Internal auditing risk analysis for medical laboratories seeking accreditation through the Hong Kong Laboratory Accreditation Scheme (HOKLAS)

Objectives@#The primary aim of this study was to determine quantitatively the extent of coverage of the Hong Kong Laboratory Accreditation Scheme (HOKLAS 015) requirements by guidance checklists (HOKLAS 016‑02 and HOKLAS 021). @*Methods@#The level of conformance requirement coverage of HOKLAS 015 by HOKLAS 016‑02 and HOKLAS 021 was calculated by an evaluation checklist based on conformance requirements in HOKLAS 015. A distribution analysis of conformance requirements relating to the International Standard ISO 15189:2012 process‑based quality management system model was also performed to elicit further coverage information. @*Results@#HOKLAS 016‑02 was found to provide coverage of 76% while HOKLAS 021 was found to provide coverage of 11%. HOKLAS 015 was also found to have a distribution coverage of 78% relating to the International Standard ISO 15189:2012 process‑based quality management system model.@*Conclusion@#The results of this analysis should be of value to medical laboratories wishing to maintain the internal auditability required by HOKLAS 015 by gaining an awareness of the extent of coverage provided by HOKLAS 016‑02 and HOKLAS 021.

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(AU)

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(AU)

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(AU)

Fundamentos teóricos para un sistema de gestión de la calidad en el Laboratorio Provincial de Biología Molecular

El establecimiento de un sistema de gestión de la calidad es obligatorio para algunas instituciones de salud, entre las que se encuentra el Laboratorio de Biología Molecular, esto queda explícito en la Regulación D 03-21, que plantea la obligatoriedad de su cumplimiento para los laboratorios clínicos que se basan en técnicas de biología molecular. El objetivo del presente texto es exponer los presupuestos teóricos que sustentan un estudio sobre la gestión de la calidad en el mencionado laboratorio. Se realiza una revisión documental a partir de artículos publicados en el período comprendido de 2012-2022. Del total de las fuentes consultadas en las plataformas de acceso a bases de datos de la red de información de la salud cubana Infomed: PubMed, Scopus, SciELo, Redalyc, y Dialnet, se seleccionaron 33 para la revisión al considerar que abordaban el tema con mayor profundidad. La adopción de un sistema de gestión de la calidad garantiza y gestiona el alto nivel de los servicios, aumenta la satisfacción del cliente y el prestigio de la organización.

The establishment of a quality management system is mandatory for some health institutions, among which is the Molecular Biology Laboratory. This is explicit in Regulation D 03-21, which makes compliance mandatory for laboratories. clinical trials that are based on molecular biology techniques. The objective of this text is to present the theoretical assumptions that support a study on quality management in the aforementioned laboratory. A documentary review is carried out based on articles published in the period from 2012-2022. Of the total sources consulted on the database access platforms of the cuban health information network Infomed: PubMed, Scopus, SciELo, Redalyc, and Dialnet, 33 were selected for the review considering that they addressed the topic with greater depth. The adoption of a quality management system guarantees and manages the high level of services, increases customer satisfaction and the prestige of the organization.

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.

Elaboración e implementación de un protocolo para la Hora Dorada de recién nacidos prematuros utilizando ciencia de la implementación / Elaboration and implementation of a protocol for the Golden Hour of premature newborns using an Implementation Science lens / Elaboração e implementação de protocolo para Hora Ouro do recém-nascido prematuro utilizando ciência da implementação

Objetivo: describir el proceso de diseño e implementación de un protocolo de atención para la primera hora de vida del recién nacido prematuro. Método: investigación participativa, que utilizó el marco de la ciencia de la implementación y los dominios del Consolidated Framework for Implementation Research. Estudio realizado en un hospital escuela del sureste de Brasil, con la participación del equipo multidisciplinario y de los gestores. El estudio se organizó en seis etapas, mediante del ciclo de mejora continua (Plan, Do, Check, Act): diagnóstico situacional; elaboración del protocolo; capacitaciones; implementación del protocolo; relevamiento de barreras y facilitadores; seguimiento y revisión del protocolo. Los datos fueron analizados mediante estadística descriptiva y análisis de contenido. Resultados: el primer protocolo de la Hora Dorada de la institución fue organizado por el equipo multidisciplinario a partir de un enfoque colectivo y dialógico. El protocolo priorizó la estabilidad cardiorrespiratoria, la prevención de hipotermia, hipoglucemia e infección. Después de cuatro meses de capacitación e implementación, el protocolo fue evaluado como una intervención de calidad, necesaria para el servicio, de bajo costo y de poca complejidad. La principal sugerencia de mejora fue realizar actividades educativas frecuentes. Conclusión: la implementación generó cambios e inició un proceso de mejora de la calidad de la atención neonatal, es necesario que la capacitación sea continua para lograr mayor adherencia y mejores resultados.

Objective: describe the process of designing and implementing a care protocol for the first hour of life of premature newborns. Method: a participatory research study using an implementation science framework, the Consolidated Framework for Implementation Research (CFIR) was employed to determine drivers and facilitators of implementation success of the Golden Hour protocol for newborns at a large university hospital in southeastern Brazil. A multi-professional team, including first line providers and managers participated in six stages of quality improvement: situational diagnosis; protocol elaboration; training protocol implementation; barrier and facilitator assessment; and protocol monitoring and review. Qualitative and monitoring data collected across these six stages were analyzed using descriptive statistics and content analysis. Results: the institution's Golden Hour protocol was organized by the multi-professional team based on a collective and dialogical approach. The protocol prioritized the infant's cardiopulmonary stability, as well as prevention of hypothermia, hypoglycemia and infection. After four months of implementation, the care team was evaluated the protocol as a good quality intervention, necessary for the service, low-cost and not very complex. One suggested improvement recommended was to carry out refresher training to address staff turnover. Conclusion: implementation of the Golden Hour protocol introduced an appropriate and feasible neonatal care quality improvement process, which requires periodic refresher training to ensure greater adherence and better neonatal results.

Objetivo: descrever o processo de elaboração e implementação de protocolo assistencial para a primeira hora de vida do recém-nascido prematuro. Método: pesquisa participativa, que utilizou referencial da ciência da implementação e os domínios do Consolidated Framework for Implementation Research. Estudo realizado em hospital universitário no sudeste do Brasil, com participação da equipe multiprofissional e gestores. O estudo foi organizado em seis etapas, por meio do ciclo de melhoria contínua (Plan, Do, Check, Act): diagnóstico situacional; elaboração do protocolo; treinamentos; implementação do protocolo; levantamento de barreiras e facilitadores; monitoramento e revisão do protocolo. Os dados foram analisados por estatística descritiva e análise de conteúdo. Resultados: o primeiro protocolo Hora Ouro da instituição foi organizado pela equipe multiprofissional a partir de uma abordagem coletiva e dialógica. O protocolo priorizou a estabilidade cardiorrespiratória, prevenção de hipotermia, de hipoglicemia e de infecção. Após treinamento e implementação por quatro meses, o protocolo foi avaliado como uma intervenção de qualidade, necessária ao serviço, de baixo custo e pouco complexa. A principal sugestão de melhoria foi realizar ações educativas frequentes. Conclusão: a implementação provocou mudanças e iniciou um processo de melhoria da qualidade da assistência neonatal, sendo necessária a manutenção dos treinamentos para maior adesão e melhores resultados.

El valor de estar acreditados / The value of accreditation

Los laboratorios clínicos desempeñan un papel cada vez más central en el proceso de atención siendo líderes en el campo de la gestión de la calidad de la salud. Desde hace algunos años hay un creciente interés en la mejora de la calidad de aquellas actividades que tienen un alto impacto en la seguridad del paciente. En este contexto la acreditación constituye un recurso estratégico para garantizar un sistema de calidad. En el año 2020 el laboratorio obtiene la acreditación por norma IRAM ISO 15189, siendo el segundo laboratorio público acreditado por un estándar internacional en el país y el primero de un Hospital Pediátrico. Con un alcance inicial que involucra a las áreas de Química, Hematología, Serología, Endocrinología y Biología Molecular, continuamos trabajando para sostener y ampliar este alcance incluyendo entre otras, el área de Microbiología. Nuestra fortaleza más grande: el trabajo en equipo (AU)

Clinical laboratories play an increasingly central role in the care process and are leaders in the field of healthcare quality management. For some years now there has been a growing interest in improving the quality of those activities that have a high impact on patient safety. In this context, accreditation is a strategic resource to warrant the quality of the system. In 2020 the laboratory was granted accreditation by IRAM ISO 15189, being the second public laboratory accredited by an international standard in the country and the first in a pediatric hospital. With an initial coverage involving the areas of Chemistry, Hematology, Serology, Endocrinology, and Molecular Biology, we continue working to sustain and expand this coverage to include, among others, the area of Microbiology. Our greatest strength: teamwork (AU)

Gestión de calidad en equipos de gases en sangre POCT. Expandiendo las fronteras del laboratorio / Quality management in POCT blood gas equipment. Expanding the frontiers of the laboratory

La realización de pruebas de laboratorio en el lugar de atención del paciente (POCT) de equipos de gases en sangre representa un desafío continuo tanto para los usuarios como para el laboratorio. La vulnerabilidad al error y la amenaza del riesgo que rodea esta forma de trabajo obliga a establecer un sistema de trabajo robusto para la obtención de un "resultado confiable" cerca del paciente crítico. La formación de un grupo interdisciplinario, la capacitación de usuarios externos al laboratorio, el aseguramiento de la calidad analítica y la conectividad, son los cuatro pilares sobre los cuales se sostiene el éxito de esta nueva era de laboratorio clínico. Además es necesaria la reinvención de la imagen bioquímica, asumiendo un rol de líder, comunicador, asesor e integrado al sistema de salud (AU)

Point of care laboratory testing (POCT) with blood gas equipment is an ongoing challenge for both the users and the laboratory. The vulnerability to error and the threat of risk that surrounds this way of working necessitates the establishment of a robust working system to obtain "reliable results" for the critically ill patient. The creation of an interdisciplinary group, the training of external users, analytical quality assurance, and connectivity are the four pillars on which the success of this new era of clinical laboratories is based. It is also necessary to reinvent the biochemical image, assuming the role of leader, communicator, and advisor integrated into the health system (AU)

Patient satisfaction in ambulatory anesthesia assessed by the Heidelberg Peri-anaesthetic Questionnaire: a cross-sectional study

Abstract Background: Service quality in anesthesiology has been frequently measured by morbidity and mortality. This measure increasingly considers patient satisfaction, which is the result of care from the client's perspective. Therefore, anesthesiologists must be able to build relationships with patients, provide understandable information and involve them in decisions about their anesthesia. This study aimed to evaluate the peri-anesthetic care provided by the anesthesia service in an ambulatory surgery unit using the Heidelberg Peri-anaesthetic Questionnaire. Methods: This cross-sectional study used the Heidelberg Peri-anaesthetic Questionnaire to evaluate 1211 patients undergoing ambulatory surgery. We selected questions that showed a greater degree of dissatisfaction and correlated them with patient characterization data (age, sex, education, and ASA physical status), anesthesia data (type, time, and prior experience), and surgical specialty. Results: Questions in which patients tended to show dissatisfaction involved fear of anesthesia and surgery, feeling cold, the urgent need to urinate, pain at the surgical site, and the team's level of concern and speed of response in relieving the patient's pain. Conclusion: The Heidelberg Peri-anaesthetic Questionnaire proved to be a useful tool in identifying points of dissatisfaction, mainly fear of anesthesia and surgery, feeling cold, the urgent need to urinate, pain at the surgical site, and the team's level of concern and speed of response in relieving the patient's pain in the population studied. These were correlated with patient, anesthesia, and surgical variables. This allows the establishment of priorities at the different points of care, with the ultimate goal of improving patient satisfaction regarding anesthesia care.

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)

Reflections on Research and Development Institutions Becoming Medical Device Registrants / 中国医疗器械杂志

As the special subject of the applicant for registration of medical device, the research and development institutions have insufficient conditions and abilities to become medical device registrants, and there are certain difficulties in the actual registration application process, such as not clearing the certification path for the research and development institutions to hold the certificate. In view of the existing problems, by comparing the path of medicine research and development institutions to become medical device registrants and combining with the actual medical device industry to give relevant suggestions, including improving quality management over the whole life cycle of medical devices, quality and safety responsibility ability of research and development institutions, establishing the registration and certification path of research and development institutions, supporting laws and regulations, etc., so as to ensure that the research and development institutions become medical device registrants successfully.

Analysis for Key Points of Registration Applications and Difficulties of Process Control of 3D Printed Customized Dentures / 中国医疗器械杂志

With the highlighted advantages of 3D printing technology in the field of dental prosthodontics, there is increasing in the numbers of registration applications for additive manufacturing customized dentures. However, there is still a lack of unified analysis in the core elements of process control, the key points of registration and the safety production quality control. Based on the current research status of the industry, the study is intended to clarify confusion and difficulties, deeply analyse the mechanism of the product defects, sort the core elements of process control, then try to establish a systematic evaluation system from product performance research, key process verification, production quality control and the description of registration files, so that it can provide help for practitioners to clarify research direction, establishing quality management system, improving the efficiency of registration and ensuring product quality.

Conformity evaluation of afinion 2 analyzer maintainability: Compliance practicality for Philippine National Standard PNS ISO 15189:2013 Accreditation

Objectives@#The implementation of Philippine National Standard PNS ISO 15189:2013 to support the medical laboratory to produce competent results is a recognised challenge. It is apparent that the approach of ensuring the equipment availability can be specifically optimised. No known research has focused on exploring on the conduct of conformity evaluation of Afinion 2 Analyzer maintainability for the PNS ISO 15189:2013 accredited medical laboratory. The aim of the current study was to develop a practical tool for the medical laboratory to support the internal audit process by determining the compliance status of Afinion 2 Analyzer maintainability. @*Methods@#The relevant conformance requirements in Clauses 4 (Management requirements) and 5 (Technical requirements) of PNS ISO 15189:2013, manufacturer requirements and specific requirements for accreditation from 70/101 (69%) accreditation bodies in 80/249 (32%) countries were identified as specific audit criteria for Afinion 2 Analyzer conformity evaluation checklists for the maintenance and reference equipment.

Practice of structured electronic medical record design and quality management / 中华医院管理杂志

In order to assist in the standardization and maturity evaluation of national hospital information interconnection, and further standardize the application and management of hospital medical record data, a hospital carried out the practice of design of structured medical records and the corresponding quality management from April 2021. Based on the six sigma quality management method, the hospital had developed universal templates for electronic medical records and a list of candidate electronic medical record templates. The problems faced by medical record data had been analyzed, and improvement strategies had been proposed from three levels: template design, software functionality and management services. The clinical departments were guided to design and develop various structured electronic medical record templates for specialties and specialized diseases, and established a medical record template design and quality management method. The hospital had ultimately designed a total of 614 structured electronic medical record templates that met the actual needs of the hospital. This practice enhanced the scalability of structured templates and quality of the data, and achieved localization and specialization of medical record templates while meeting the requirements of information interconnection and sharing, providing reference for promoting the interconnection and sharing of electronic medical records of hospitals in China.

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.

Current situation of Investigator-Initiated Clinical Trial quality management: A scoping review / 中华医学科研管理杂志

Objective:To systematically identify and summarizes the weaknesses of the key aspects of Investigator-Initiated Clinical Trial (IIT) quality management in China, and quantitatively assess these weaknesses with a synthesis of relevant evidence, thereby providing references for the subsequent establishment of a complete IIT quality management system in China.Methods:According to the Scoping review report checklist (PRISMA-ScR statement), we conducted a systematic literature retrieval and screening, data extraction, and result synthesis of IIT quality management issues after defining the research questions.Results:73 eligible studies were eventually included. It was found that the most frequently explored issues were a lack of guidance and support from methodological and statistical experts at the project initiation stage (60.9%), a lack of research funding or improper funding management at the project implementation stage (49.3%), mismanagement of archival materials at the project completion stage (70.0%). Meta-analysis results showed that after evidence synthesis, the incidence of irregular informed consent signing, untraceable raw data, delayed study progress, and protocol violation were all above 40%, but there was heterogeneity in the results.Conclusion:Some outstanding issues in IIT quality management need to be addressed. Future studies should conduct more practical research to obtain quantitative data, undertake demonstrative application of management protocols, further carry out pioneering exploration and research in the field of IIT quality management, and propose effective solutions and strategies to improve IIT quality.

Development and management of clinical mass spectrometry in laboratory medicine / 中华检验医学杂志

Clinical mass spectrometry plays an increasingly important role in the analysis of hormones, drugs, vitamins, amino acids,etc. The analysis of large molecular peptides and proteins by mass spectrometry has also attracted wide attention. The development of clinical mass spectrometry technology still faces many challenges. With continuous efforts, clinical mass spectrometry technology will have a better future.

Research on mixed teaching platform of pediatric clinical laboratory practice teaching based on the Laboratory Quality Management System / 中华医学教育探索杂志

Objective:To explore application of mixed teaching platform in the clinical practice teaching of the laboratory medicine in Children's hospitals.Methods:We constructed a mixed online and offline teaching platform based on the Laboratory Quality Management System (LQMS) in the Children's Hospital of Chongqing Medical University. The undergraduates from Batch 2016 ( n=15) and Batch 2018 ( n=12) of College of Laboratory Medicine of Chongqing Medical University were taken as control group and experimental group respectively. Traditional teaching method was adopted by the control group, and the mixed teaching method was adopted by the experimental group. The results of two groups' clinical practice assessment, rate of outstanding students (total score ≥ 90) and rate of satisfaction (score ≥ 90) were compared to evaluate the teaching effect. SPSS 17.0 was used to conduct t-test and Chi-square test. Results:The database of teaching platform includes 68 teaching cases, 198 pieces of courseware, 305 clinical cases and 3 036 atlases. The test bank has accumulated 4 657 tests, covering clinical laboratory, immunology, biochemistry, microbiology and blood transfusion. The results of students in experimental group were significantly better than those of the control group [the score of clinical practice assessment: (85.90±5.04) vs. (78.90±6.75)( P<0.05); rate of outstanding students: 33.3% (4/12) vs. 6.7% (1/15), P>0.05; rate of satisfaction: 86.7% (13/15) vs. 100.0% (12/12) ( P>0.05). Conclusion:The mixed online and offline teaching platform based on the LQMS is highly recognized by students and can significantly improve the effect of clinical practice teaching, which can provide typical medical case teaching at any time and make up for limited case type in children's hospital.