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Trata de nota técnica sobre Práticas Avançadas de Enfermagem (PAE) no Brasil, elaborada por comissão e submetida à aprovação do plenário do Conselho Federal de Enfermagem (Cofen). O documento aborda conceitos, ações, implementação e regulação das práticas avançadas de Enfermagem, expandindo os limites do escopo da atuação do enfermeiro e reforçando a sua prática clínica. (AU)
This is a technical note on Advanced Nursing Practices (ANP) in Brazil, prepared by a committee and submitted for approval by the plenary of the Federal Nursing Council (Cofen). The document addresses concepts, actions, implementation and regulation of advanced nursing practices, expanding the limits of the scope of nurses' work and reinforcing their clinical practice. (AU)
Esta es una nota técnica sobre las Prácticas Avanzadas de Enfermería (PAE) en Brasil, elaborada por un comité y sometida a la aprobación del plenario del Consejo Federal de Enfermería (Cofen). El documento aborda los conceptos, acciones, implementación y reglamentación de las prácticas avanzadas de enfermería, ampliando los límites del ámbito de actuación de las enfermeras y reforzando su práctica clínica. (AU)
Subject(s)
Nursing , Global Health Strategies , Health Care Coordination and Monitoring , Advanced Practice Nursing , Practice Patterns, Nurses' , Strategies for Universal Health CoverageABSTRACT
As the medical insurance system continually evolves,the sustainable development of hospitals necessitates the establishment of an intelligent medical supervision system.With this system,hospitals can strengthen the management of specific outpatient diseases,achieve intelligent,standardized medical insurance management,and enable real-time supervision throughout the entire process.This article first outlines the background for applying the intelligent medical insurance supervision system in the management of specific outpatient diseases.It then delves into the problems in the application of this system and proposes strategies for solving the problem.These strategies include continuation of effective medical insurance cost control and decision-making management,improvement of a payment supervision system for specific diseases,establishment of an intelligent evaluation and review system for specific outpatient diseases,and development of a financial management system for specific diseases.
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Procurement constitutes a cornerstone of daily operations in public hospitals,involving medical equipment,medical materials,pharmaceuticals,infrastructure projects,office supplies,and service-oriented projects.The responsibility for procurement used to rest on various functional departments overseeing business management,a situation that often led to a lack of transparency and standardization due to decisions made by a single department or a few key cadres.To standardize procurement practices,the national policy has introduced a"procurement"and"management"separation model.In public hospitals,pro-curement includes two main aspects:"procurement"entails the actual execution of purchasing activities,including market re-search,price negotiation,tender document formulation,and contract signing;and"management"involves the preliminary re-search,budgeting and project initiation,installation and commissioning,inventory acceptance,maintenance quality control,and usage management of procured items.The separation of"procurement"and"management"is an important part of the procure-ment management unit in the modern hospital administration.This process-based division ensures the functional distinction be-tween procurement and management,fostering interdepartmental collaboration and mutual oversight,thereby mitigating procure-ment integrity while safeguarding procurement quality.
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The performance appraisal of public hospitals is the most official and authoritative assessment and evaluation of tertiary public hospitals in China,and it is an important measure to guide hospitals to improve their internal management level and achieve high-quality development.In this study,a data monitoring management system based on the performance appraisal indicators of national tertiary public hospitals was developed and constructed through intelligent collection and reporting,report in-tegration,visual analysis,data drilling,etc.,which realized the one-stop dynamic management of indicators,optimized the data filling process of national examination indicators,improved the data quality and credibility,and promoted the integration of na-tional assessment and hospital assessment.the intelligent management level of the hospital has been improved,which provides strong support for the hospital's refined operation management and scientific decision-making.
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The disposable sterile urethral catheter was described in terms of the current status of the standards of foreign countries and China and its regulation and registration.The national supervision and sampling inspection and exploratory research of the disposable sterile urethral catheter in 2018,2019 and 2021 were introduced,and the problems found and the causes were analyzed and then the countermeasures were proposed accordingly.References were provided for guiding and standardizing the development of catheter products industry.[Chinese Medical Equipment Journal,2024,45(1):84-88]
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Given the systematic, rigorous, and practical characteristics of medical disciplines, ensuring the teaching quality of online courses has become a significant focus. In traditional teaching models, teaching supervision is an important method to guarantee instructional quality, and introducing teaching supervision into online teaching activities is of great significance. This article systematically reviews and summarizes the domestic and international experience of conducting online medical courses. We explore the instructional supervision of online medical courses from the following perspectives: the meaning of supervision, the necessity of online supervision, online supervision methods and technical approaches, the feedback and application of supervision information, and the establishment of a standardized online supervision process.
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Objective To investigate the current situation,problems and suggestions of pharmacovigilance activities conducted by drug marketing authorization holders(MAH)and pharmacovigilance inspections carried by regulatory authorities.Methods A questionnaire survey was conducted on relevant institutions and personnel responsible for pharmacovigilance inspections in 31 provinces,autonomous regions,municipalities and the Xinjiang Production and Construction Corps.The MAH pharmacovigilance activities were rated from 5 aspects(5 major items and 27 specific items).Results The average overall score for 5 major items was 3.46;The average score for 27 specific activities was 3.50.The MAH scored the highest in terms of pharmacovigilance organization,personnel,and resources,and scored the lowest in terms of drug risk identification and assessment.Conclusion MAH needs to further strengthen their awareness of primary responsibility,gradually improve the pharmacovigilance system,and constantly improve the ability and level of pharmacovigilance;The drug regulatory department should also provide guidance to enterprises,establish and improve the team of inspectors,and systematically advanced various aspects of pharmocovigilance inspection.
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Objective:To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT).Methods:This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management.Results:While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration.Conclusions:Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.
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It is of great significance to construct an information platform for performance appraisal of tertiary public hospitals to realize real-time monitoring and intervention of appraisal indicators, which is conducive to the transmission of responsibility for index optimization to departments and medical groups, and to promote the fine management of hospitals and promote high-quality development.This paper introduced the practice and effect of building a performance appraisal information platform for tertiary public hospitals in four aspects: accurate data filling, timely dynamic monitoring, visual display and safety management since 2022. At the same time, suggestions were put forward for platform optimization from four aspects: data quality control, co-construction and sharing, promotion and application, and system integration, in order to provide reference for other hospitals.
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Human genetic resources are an indispensable part of national natural science and technology resources， as well as an important strategic resource for safeguarding national security， public health， and social public interests. To promote the effective protection and rational utilization of human genetic resources， as well as improve and optimize the local human genetic resources management system in China， this paper summarized the current situation of administrative approval and supervision of national human genetic resources from 2004 to 2021 by sorting out the national human genetic resources management policies and regulations. Furthermore， the current situation and progress of local human genetic resources management in China were understood from three aspects， including development planning and programs of human genetic resources， administrative licensing and penalties， and the construction of management expert committees. The main problems of local human genetic resources management in China were discussed and analyzed， such as unclear supervision， difficulty in supervision and inspection， and capacity for services. Based on the causes of the problems and the local management work， specific countermeasures and suggestions were put forward from the perspective of clarifying the regulatory policies and procedures for human genetic resources， improving the supervision and inspection mechanisms， and improving the management and service capabilities.
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On-site supervision is a risk-based regulatory system that requires the scientific development of supervision plans for quality risks and hidden dangers in pharmaceutical enterprises， the rational allocation of supervision resources based on their risk levels， and the implementation of classified supervision measures. In this study， the quality risk monitoring business support system is set up for pharmaceutical enterprises by establishing the quality risk expert database and quality risk monitoring index system for pharmaceutical enterprises based on the difficulty analysis of on-site drug supervision. Based on this support system， the quality risk classification method， the differentiated spot check strategy and business auxiliary visualization system are established. This support system is used to learn the risk level of pharmaceutical enterprises， so as to innovate supervision methods and optimize monitoring strategies. Taking Jiangxi Province as an example， it is verified that the support system can guide the risk assessment of sample enterprises， can improve the targeting of on-site drug supervision in the process of technical review， scheme editing， on-site implementation and comprehensive evaluation， and can effectively improve the quality and efficiency of supervision.
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In view of the current norms and demands of human gene editing technology at home and abroad, the paper explained that the regulatory difficulties faced by human gene editing technology were due to the conflict between economic interests and moral bottom line by constructing a game model in a hypothetical way. On this basis, the ideas of the supervision mode of human gene editing technology were put forward: establish unified international standards based on the country as the main body, enact more stringent and effective laws, to jointly deal with the behavior of genetic manipulation of human gametes, zygotes and embryos for the purpose of reproductive, and ensure the normalization and legalization of gene editing technology to avoid technology abuse.
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The frequent several ethical events in recent years suggested carry out the construction of ethical governance system involving human health-related research under the background of national governance. The subjects of ethical governance include the government, medical institutions, universities, scientific research institutes, enterprise, ethics committees, researchers, the public, etc., the multiple subjects are interrelated and interact with each other to restrict and standardize ethics through different governance tools. However, there are some problems in China’s ethical governance, such as the relative lag in the construction of ethical governance concept and system, insufficient multi-party participation, the difficulty in sole legislation to solve risk and ethical problems, the specification cannot be met, inadequate supervision, insufficient accountability for violations, researchers lack ethical awareness, ethical education lags behind and insufficient information disclosure to the public. It should be taken such as countermeasures as paying attention to the theoretical research of ethical governance system, strengthening the construction of ethical governance system, pluralistic co governance, agile governance, strengthening legislation, improving norms, implementing supervision, strengthening the construction of ethics committee, talent training, training researchers, ethical education, popular science public, academic self-discipline, information disclosure and public participation, so as to build a scientific and technological ethics governance system in line with China’s national conditions and in line with international standards, and contribute China’s wisdom for world ethical governance.
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This paper took a hospital in Anhui province as an example, aimed at the problems existing in the protection of human subjects’ rights and interests in China, and put forward relevant suggestions from the ethical perspective. The suggestions included shaping the international vision, playing the core role of ethics committee, strengthening the construction of legal and regulatory protection mechanism, setting up the human research protection committee and actively promoting the construction of subject protection system. These measures will effectively promote the construction and improvement of the rights and interests protection system of human subjects in China.
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With the reform of the medical and health system entering a critical period,public hospitals have also exposed new risks and challenges in economic operation.As an important means of hospital standardized management,internal control can better prevent and resolve the risk of hospital economic operation and ensure the sustainable operation of the hospital.By interpreting the requirements of current national policies on hospital internal control,it analyzes the functional positioning of financial and accounting supervision in hospital internal control,shares the internal control implementation path of sample hospitals from the perspective of financial and accounting supervision,and puts forward suggestions on strengthening internal control construction of public hospitals in the new era,in order to lay a good foundation for the high-quality development of hospitals.
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Different from accounting supervision and audit supervision,financial supervision pays more attention to the standardization of economic behavior from the management and governance level,financial supervision has the characteristics of comprehensiveness,foresightedness and guidance,which is very important for the healthy development of public hospital.By analyzing the main problems and challenges faced by the internal financial supervision in public hospitals,it discusses the construction of supervision system,the perfection of working mechanism,the optimization of supervision means and the construction of supervision environment,to explore the concrete ways and suggestions of improving the efficiency of internal financial supervision in public hospitals.
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Objective:To explore the focus of ethical governance in the field of artificial intelligence(Al)in medicine.Methods:By comprehensively reviewing relevant literature to compare the relevant laws and regulations of the field of AI in medicine between China and foreign countries,analyze the governance focus of potential ethical issues,and propose the corresponding governance strategies.Results:At present,the laws,regulations,and regulatory systems related to the field of AI in medicine in China need to be improved.The emphasis of ethical governance should focus on core issues such as protecting privacy rights,ensuring the transparency and fairness of algorithms,clarifying the demarcation and allocation of responsibilities,and clarifying public perceptions and attitudes.Conclusion:The government and all sectors of society should actively learn from international legislative experience,and build an omnidirectional and multi-level ethical governance system from the aspects of policy formulation,legal framework,scientific research,and technological research and development by strengthening top-level design,improving policies and regulations,attaching importance to public feedback,and strengthening interdisciplinary cooperation.
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Taking the reform of DRG payment methods as the background,it discusses how the medical in-surance department uses information technology to achieve refined monitoring and management of medical institu-tions,so as to improve the quality and efficiency of medical services and control the unreasonable growth of medical expenses.The three stages of"precision monitoring-refined supervision-precision governance"of medical insurance DRG based on"refined theory"are proposed;taking Nanjing's"medical insurance high-speed railway"as an example,a DRG refined supervision and governance model framework is constructed,and its analysis is carried out monitoring elements and governance elements,and finally put forward implementation suggestions,including hori-zontal collaboration led by medical insurance,establishing a service and cost evaluation mechanism that combines in-ternal and external services.
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In the management of public hospital,there are many methods to supervise,mainly divided into exter-nal supervision and internal management,aiming to improve the quality of medical management.With the develop-ment and progress of society,many hospitals are not only ensuring medical quality,but also continuously improving patients'humanistic care during medical treatment.As non-medical professionals,external supervisors,from the perspective of bystanders,provide reasonable suggestions to hospitals,which can help them better improve their medical experience during the medical service process.
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Objective To sort out the main subjects of China's medical insurance fund supervision and their change process in different periods,to provide a basis for deepening the reform of the medical insurance fund regulation sys-tem.Methods Social network analysis method is used to quantify the national-level policies and tap the core subjects of China's medical insurance fund supervision.Results A total of 63 policies were included,and 195 regulatory sub-ject codes were obtained.The main regulatory subjects during the embryonic period of medical insurance fund super-vision were mainly insurance operators and relied on medical insurance fund supervision organizations.The main regu-latory subjects during the exploration period were mainly the insurance administration and the insurance agency and began to pay attention to social participation.The main regulatory subjects in the development period were mainly the Healthcare Security Administration and its handling agencies,with the collaboration of relevant departments.The participation of social subjects is obvious,and third-party professional institutions become important subjects.Con-clusion The supervisory subjects of China's medical insurance fund have embodied the logic of change from decen-tralization of responsibilities to centralized and unified functions,from multi-regulation to integrated multi-sectoral linkage,and from government-led to the introduction of social and market forces.The participation of multiple sub-jects is the development trend of medical insurance fund supervision in the future,and the capacity of collaborative governance of medical insurance fund supervision should be continuously improved.