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![]() «Управление качеством в здравоохранении» № 2 / 2018 15 June 2018 M.A. Murashko, I.V. Ivanov, A.I. Panin The Patient Safety today Annotation: The patient safety, Tokyo Declaration on Patient Safety of April 2018, “the culture of safety”, clinical recommendations, stagnation of health care system, draft of the project on implementation of the proposals of the Federal Service for Supervision in Health Care on the organization of internal quality control and safety of medical activities in a medical organization. Now the public health is one of the most important development streams of the country for a long historical period and for the ensuring stability and well-being in society and national security of the state as a whole. The patient security issue is the global one, whose main ways of solving belong to the field of safe medical activities; monitoring systems in the areas of safety of medical devices and drugs have been created and have been functioning for a long time. The Federal Service conducts such a kind of monitoring for Supervision in Health Care. Key words: patient safety, clinical recommendations, medical care«Управление качеством в здравоохранении» 2 / 2018 15 June 2018 PATIENT SAFETY TODAY Ivanov IV, Minulin I.B. TESTING LISTS (LIST OF CONTROL ISSUES) IN THE WORK OF THE FEDERAL SERVICE FOR SUPERVISION IN HEALTH CARE AND THEIR IMPORTANCE FOR THE MEDICAL ORGANIZATION Annotation: The formation of a transparent and simple system oblogatory requirements for state control (supervision) objects is one of the most important priorities of the reform of control and supervision activities in the Russian Federation, implemented since 2016. The perpose of the carried reform is reducing the level of damage to legally protected values - life and health of citizens, reducing the administrative burden on citizens and organizations - the subjects of control and supervision, increasing the level of maturity and effectiveness of the organization of control and surveillance activities. In order to achieve the target goals the Federal Service for Supervision in Health Care implements the work on the formation of one whole register of normative legal acts regulating compulsory healthcare requirements, ensuring access for citizens and organizations to information on the procedure for conducting inspections, on standardizing verification activities and introducing unified approaches in the implementation of one type of control throughout the country, including training of officials, which put in force state control on the organization of the functioning of a management system of risks for causing harm to the installation according to the procedure of the relevant certification, as well as the development and improvement of the methodology for assessing the effectiveness and efficiency; activities of local bodies, with the development of tools aimed at motivating the activities of both leaders and state civil agents. Key words: control and supervision activities, one whole register, training of officials, improvement of methods procedure.Кто есть кто в медицине №1 2018 8 April 2018 Who is in the Medical Sector? №1 2018 FBGU «Center of Monitoring and Clinical and Economic Inspection» The FBGU “Center of Monitoring and Clinical and Medical Inspection” of Federal Service for Supervision in Health Care is one of three Expert Institutions within the jurisdiction of the Federal Service for Supervision in Health Care. The general director Igor Vladimirovich Ivanov told us about special features of the work of the “Center”. Our organization is the executor of the state order for equality, efficiency and security of medical products, which are going through the process of state registration and coming to the Russian market regardless of whether they are foreign producers or domestic ones. In case, when the already registered medicines and those, which circulate in the territory of the Russian Federation, undergo certain changes on the side of the producer, are updated and implemented, we also conduct an examination of the validity of the changes introduced and the confirmation of their quality, efficiency and safety. Our functions include assistance to state control over the circulation of medical devices. In the course of ongoing activities, products and documentation for them are withdrawn. Next, the examination and expert assessment are held, which demonstrate how much all this corresponds to the documentation for the registered product submitted to the Federal Service for Supervision in Health Care. This mission is very crucial and it allows excluding the circulation of unregistered products on the territory of the Russian Federation and thereby protecting our citizens.Менеджер Здравоохранения № 1 / 2018 6 April 2018 ![]() СТАНДАРТЫ МЕДИЦИНСКОЙ ПОМОЩИ: ОБЯЗАТЕЛЬНЫ ЛИ ОНИ ДЛЯ СОБЛЮДЕНИЯ МЕДИЦИНСКИМИ ОРГАНИЗАЦИЯМИ? Аннотация. В статье рассматриваются вопросы, связанные с организацией работы по установлению и оформлению клинического и предварительного диагнозов в соответствии с требованиями приказа от 10.05.2017 г. No 203н «Об утверждении критериев оценки качества медицинской помощи». Даны практические рекомендации по заполнению утвержденных МЗ РФ форм медицинской документации (медицинской карты пациента, получающего медицинскую помощь в амбулаторных условиях, и медицинской карты стационарного больного) с учетом новых требований, предъявляемых к установлению и оформлению предварительного и клинического диагнозов. Обращено внимание руководителей медицинских организаций на то, что теперь критерием качества медицинской помощи является и выполнение требований к обязательному проведению консилиума врачей в случае затруднения установления клинического диагноза в регламентированные сроки. Ключевые слова: качество и безопасность медицинской деятельности, контроль качества медицинской помощи, медицинская организация, проведение проверок, контроль. Менеджер Здравоохранения № 8 / 2017 27 October 2017 Abstract. In the Federal legislation of public health has stated that «medical care is organized and is … on the basis of standards of medical care…». The phrase «on the basis of standards of medical care» is interpreted differently in medical institutions, in connection with which the question often arises: «do I have to perform the standards of care, or they are Advisory in nature?». In the article the authors substantiate and prove that is currently approved in the prescribed manner the standards of care mandatory for medical organizations and doctors.Вестник Росздравнадзора Выпуск № 4 / 2017 16 October 2017
Вестник РЗН 4-2017.
И.В. ИВАНОВ, Д.Т. ШАРИКАДЗЕ, С.В. БОБРОВА Предложения (практические рекомендации) по организации внутреннего контроля качества и безопасности медицинской деятельности в поликлинике (Полная версия) В статье кратко изложены Предложения по организации внутреннего контроля качества и безопасности медицинской деятельности, разработанные ФГБУ «ЦМИКЭЭ» Росздравнадзора для медицинских организаций амбулаторно-поликлинического звена. Описан уни- фицированный подход к организации внутреннего контроля, как основного элемента системы управления качеством, в поликлинике. Сформулированы 15 базовых разделов внутреннего контроля, по которым определены качественные и количественные критерии. Предложены для использования при проведении внутреннего контроля оценочные листы по каждому из разделов. Разработана система оценки качества и безопасности медицинской деятельности в поликлинике.
Ключевые слова: медицинская организация, поликлиника, внутренний контроль качества Стандарты и качество № 06 / 2017 25 September 2017 Audit as a tool of healthcare quality assessment<br> <br> The authors introduce the results of self-assessment and external audits of medical organizations that participate in implementation of the proposals (practical suggestions) of Roszdravnadzor to arrange inner quality and safety control of medical activity.Вестник Росздравнадзора Выпуск № 4 / 2017 22 September 2017 Ivanov I.V., Kovalishena O.V., Shvabsky O.R. Experience in auditing the quality and safety assurance of medical activities in a healthcare organization within the «Epidemiological safety» section The article summarizes the first results of the audits of the internal quality control and safety of medical activities in the healthcare organizations within the «Epidemiological safety. Prevention of healthcare-associated infections (HCAI)» section to identify outstanding issues and all possible ways to solve such issues, and prospective activities. Keywords: audit; internal quality and safety control of medical activities; epidemiological safety; prevention of healthcare-associated infectionsЗаместитель главного врача № 5 / 2017 7 August 2017 ![]() Игорь Владимирович ИВАНОВ, канд. мед. наук, генеральный директор ФГБУ «Центр мониторинга и клинико-экономической экспертизы» Росздравнадзора, Москва Внутренний контроль качества и безопасности: первые практические шаги ВАЖНОЕ В СТАТЬЕ: 1 Определите ответственных за каждое направление рекомендаций Росздравнадзора 2 Проанализируйте, на какие структурные подразделения распространяются требования рекомендаций 3 Проведите самооценку по направлениям. Любое несоответствие опишите как можно более детально 4 Разработайте план корректирующих мероприятий Вестник Росздравнадзора Выпуск № 3 / 2017 27 July 2017 Murashko M.A., Seregina I.F., Matytsin N.O. Methodological foundations for applying risk-oriented approach in exerting state control in health care Risk-oriented approach emerges in 2017 as the leading concept in reforming state control (surveillance) in the Russian Federation. By assigning activities of legal entities or entrepreneurs to certain risk categories the intensity (type, duration, intervals) of the relevant inspections is defined. Risk-oriented approach is applied in order to increase control mechanism transparency and clarity for those undergoing control. It can also help decreasing their expenses and define integrated approaches to control including introduction of standardised checklists. <br> Keywords: risk-oriented approach, risk category, state control, quality control, quality management, health care system<br> <br> <br>Медицинский алфавит № 20 / 2017 26 July 2017 Methodical aspects of organizing and conducting internal audits in medical organizations A. V. Emanuel, S. M. Tsibina, E..V. Averyanova, A. V. Avramenko, G. A. Ivanov, O. R. Shvabsky, R. Bošković, E. A. Duvanova, A. V. Kalenskaya Scientific and Research Institute of Public Health Service and Medical Management, Moscow; Test — St. Petersburg Co., Saint Petersburg; Consultative and Diagnostic Centre with Polyclinic of the Administration of the President of the Russian Federation, Moscow; Centre for Monitoring and Clinical and Economic Expertise of Roszdravnadzor, Moscow; Bonex Inženjering Co., Belgrade, Serbia; Centre of Laboratory Diagnostics Co., Moscow; Central Scientific and Research Institute for Epidemiology, Moscow; Russia<br> <br> The article considers methodical approaches to the organization and implementation of internal audits in medical organizations. The basic complexities, with which the employees of medical organizations are involved in the creation of services and subdivisions by internal audits, are described. Key words: internal audits, ISO, quality management, quality management system.<br>Контроль качества продукции №7/2017 26 July 2017
Контроль качества в медицинской организации. Интервью с генеральным директором ФГБУ «Центр мониторинга и клинико-экономической экспертизы» Росздравнадзора И.В. Ивановым
• о специфике системы качества в медицинских организациях; Читайте и узнаете: • какие рекомендации по организации внутреннего контроля качества и безопасности медицинской деятельности дает Росздравнадзор; • с какими трудностями могут столкнуться руководители медицинских организаций при внедрении системы качества Теги: Контроль качества продукции Вестник Росздравнадзора Выпуск № 3 / 2017 25 July 2017 Murashko M.A., Krupnova I.V., Ivanov I.V. Risk-oriented approach in planning of control measures By introducing a risk-oriented differentiated approach to the implementation of control measures it is possible to considerably improve the cost efficiency of organisations exerting control and surveillance. This can be achieved by concentrating efforts of state inspectors on most important directions. Keywords: control measures, risk-oriented approach<br> <br> <br>Менеджер Здравоохранения № 5 / 2017 3 July 2017 Piven D. V., Kitsul I. S., Ivanov I. V. A new control tool in healthcare: a control without interacting with legal entities and individual entrepreneurs (Saint-Petersburg, Irkutsk, Moscow, Russia) Abstract. The article deal with the emergence of a new monitoring tool in the health sector – organization and conduct of control measures without the cooperation of legal entities and individual entrepreneurs. The authors note that the legislation of the Russian Federation contains a significant amount of the requirements for medical organizations to embed and provide information. Thus compliance with these requirements will be validated by the Supervisory authorities by carrying out control activities without interaction with legal entities, individual entrepreneurs. All this increases the responsibility of medical organizations and confronts them with new challenges when conducting internal monitoring the quality and safety of medical activity. <br>Keywords: control without interaction with legal entities and individual entrepreneurs, requirements, quality and safety of medical activity, medical organization, caution.Скорая медицинская помощь №2/2017 21 June 2017 This article presents the results of analysis of control activities of the Federal Service for Surveillance in healthcare (Roszdravnadzor) on the organization of emergency medical care in Russian Federation and determined the main typical breach. Discusses recent changes in the legislation in terms of improving the organization of emergency medical care system in Russian Federation. Suggests key areas for further improvement of emergency medical care. <br> Key words: internal quality control, quality management system, control of emergency medical services, improving the organization of emergency medical care and ambulance services, Federal Service for Surveillance in Healthcare, emergency medicine<br> <br>Менеджер здравоохранения №2 / 2017 13 April 2017 Пивень Д.В., Кицул И.С., Иванов И.В.
Новые задачи и направления работы врачебной комиссии в системе обеспечения и контроля качества и безопасности медицинской деятельности Ключевые слова: врачебная комиссия, медицинская организация, качество медицинской помощи, качество и безопасность медицинской деятельности, безопасность медицинской деятельности. Вестник Росздравнадзора Выпуск № 1 / 2017 22 March 2017 Emanuel A.V., Ivanov G.F., Taut D.F., Zimakova N., Averyanova E.V. Quality management systems in health care: myths and reality This article describes the author's approach to understanding the quality management system (QMS) in health care and its major elements. It analyses the most common problems arising out of the QMS introduction into medical organizations (MO), dissects the key mechanisms of QMS: application of quality and risk management indicators. The clinical case shows how QMS elements can be used in practice. The authors express their vision of the main trends in this direction, QMS difficulties most frequently encountered in MO, make an attempt to identify the success and failure factors in the QMS standards application in MO. Keywords: QMS, ISO, risk management, quality indicators<br> <br>Вестник Росздравнадзора Выпуск № 1 / 2017 22 March 2017 Ivanov I.V., Sharikadze D.T., Berseneva E.A., Miroshnikov Yu.V. Methodological approaches to building a risk-oriented control and surveillance model in the health sector At the stage of transition to the risk-control-oriented supervision model, Roszdravnadzor should establish the risk categories (hazard classes), define the criteria for referring activities of legal entities and individual entrepreneurs (objects of supervision and control) to a certain risk category, set the frequency of routine monitoring and classification (ranking) of objects of control (supervision) by the risk categories (hazard class). The article describes the common methodological approaches developed by Roszdravnadzor in building the risk-oriented control and supervision model. Keywords: control and supervision, risk-oriented model, risk categories, hazard classes, RoszdravnadzorУправление качеством в здравоохранении №1 2017 10 March 2017 ![]() И.В. Иванов, канд. мед. наук; Д.Т. Шарикадзе; О.Р. Швабский.
Внутренний контроль качества и безопасности медицинской деятельности в поликлинике: практические рекомендации
Год назад Росздравнадзор выпустил рекомендации по организации внутреннего контроля качества и безопасности медицинской деятельности для стационаров. Подготовлены аналогичные рекомендации и для поликлиник. Правда, официально они пока не утверждены... Однако уже сейчас разработчики рекомендаций описали основные критерии, по которым будет оцениваться качество ведения внутреннего контроля в вашей поликлинике. Если налажен внутренний контроль, то не страшны и внешние проверки! Здравоохранение №03 / 2017 10 March 2017 ![]() И.В. ИВАНОВ.
Внутренний аудит качества и безопасности: как организовать и какие документы требовать от подчиненных.
При каждой плановой проверке Росздравнадзор смотрит, налажена ли в медорганизации система внутреннего контроля качества и безопасности медицинской деятельности. В основе этой системы – внутренний аудит. Порядок внутреннего контроля устанавливает руководитель медорганизации. Источник информации для инспекторов – локальные акты медорганизации по внутреннему аудиту. Утвержденных форм нет. В статье мы описали все этапы организации внутреннего аудита и привели образцы локальных актов, которые устроят инспекторов Росздравнадзора
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