Articles with tag: «mandatory requirements»

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  • 2022 № 6 Features of inspection in 2022: what medical organizations need to be prepared for

    The article shows that the decisions adopted in March 2022 on a moratorium on scheduled inspections until the end of 2022 not only do not mean a complete stop of measures for monitoring (supervision) of medical activities carried out by medical organizations, but also actively stimulate the practical implementation of a number of basic provisions of the reform of control and supervisory activities. Medical organizations, despite the moratorium on scheduled inspections announced by the end of 2022, need to ensure strict compliance with the requirements of legislation to ensure and control the quality and safety of medical activities; constant readiness for the implementation by the supervisory authorities of new control (supervisory) measures without interaction with the controlled person, as well as professionallactic events.

    Authors: Piven D. V. [59] Kitsul I. S. [59] Ivanov I. V. [30]

    Tags: control (supervision) without interaction2 controlled person2 mandatory requirements3 moratorium on scheduled inspections1 on-site examination2 quality and safety of medical activity12 reform of control and supervisory activities1 safety monitoring2 unscheduled  inspections2

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  • 2021 № 9 What has changed for medical organization with the adoption of the new regulation on federal state control (supervision) quality and safety of medical activity

    The article analyzes the Regulations on the Federal state control (supervision) of the quality and safety of medical activities, approved by the Decree of the Government of the Russian Federation № 1048 of June 29, 2021. The following is noted: The Regulation defines a broader list of issues that are now the subject of federal state control of the quality and safety of medical activities; The regulation ensures continuity with the Federal Law № 248-FZ of 31.07.2020 «On State Control (Supervision) and Municipal Control in the Russian Federation», on the one hand, and with the Requirements for the organization and Conduct of internal quality control and Safety of Medical Activities approved by the Decree of the Ministry of Health of the Russian Federation № 785n of 31.07.2020, on the other hand; for the first time, the risk profile of causing harm (damage) to the life and health of citizens is fixed for supervisory
    authorities as the most important area of work in the field of state control of the quality and safety of medical activities.

    Authors: Piven D. V. [59] Kitsul I. S. [59] Ivanov I. V. [30]

    Tags: federal state control (supervision)1 mandatory requirements3 medical organization53 quality and safety of medical activities9 supervisory authorities in the field of healthcare1

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  • 2022 № 3 Control (Supervision) without interaction with a controlled person, as a new form of control over the provision of paid medical services: what the heads of medical organizations need to know

    Currently, Roszdravnadzor and Rospotrebnadzor in the established areas of state control (supervision) over the provision of paid medical services are entitled to exercise control (supervision) without interaction with a controlled person, in which the following are carried out: monitoring compliance with mandatory requirements and on-site follow-up. Due to the fact that control (supervisory) measures without interaction with the controlled person are implemented without prior notification of the controlled persons, the conduct of these measures by the supervisory authorities is likely to entail an increase in the number of unscheduled inspections of medical organizations, including
    control procurement. The emergence of a new type of control (supervisory) measures without interaction with a controlled person is one of the significant factors that increase the responsibility of medical organizations in terms of compliance with the requirements established by law for the procedure and conditions for the provision of paid medical services.

    Authors: Piven D. V. [59] Kitsul I. S. [59] Ivanov I. V. [30]

    Tags: control (supervision) without interaction2 controlled person2 mandatory requirements3 on-site examination2 paid medical services22 quality and safety of medical activities9 safety monitoring2

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