Focus of problem
  • 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. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: control (supervision) without interaction1 controlled person1 mandatory requirements2 on-site examination1 paid medical services17 quality and safety of medical activities9 safety monitoring1

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  • 2020 № 6 What checks are cancelled and which are retained for medical organizations of the country in terms of the situation with coronavirus infection

    The article contains a detailed analysis of the legal acts issued in April 2020 in connection with coronavirus infection and regulating the issues of state control (supervision) in relation to medical organizations until the end of 2020. In the publication, the authors present the main control and Supervisory measures that will be carried out in medical orga- nizations during 2020. A number of issues related to the legal regulation of control and Supervisory activities that require clarification are identified. In terms of the quality and safety of medical activities, the attention of medical organizations is drawn to the expediency of ensuring their own maximum readiness for various scenarios of carrying out certain control and Supervisory measures established before the end of 2020.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: coronavirus  infection5 license  control1 medical organizations21 on-site unscheduled  inspections1 quality and safety of medical activity10 remote  monitoring  tools1 scheduled  inspections1 unscheduled  inspections1

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  • 2020 № 1 Is the medical organization obliged to ask the patient for an identity document when applying for paid medical services?

    The article shows and proves that when a patient applies for paid medical services, a medical organization is obliged to ask him for an identity document. First of all, this is enshrined in the requirements for the maintenance of accounting and reporting documentation established by the legislation of the Russian Federation. At the same time, the authors emphasize that even if the patient does not have an identity document, the refusal to conclude a contract for the provision of paid medical services is unacceptable. The issue of presentation of an identity document by a patient when applying for the provision of paid medical services became particularly relevant after the introduction of such a control tool as the control purchase of paid medical services.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: control purchase2 identity document1 medical documentation2 medical organization48 paid medical services17 patient10 quality control and safety of medical activity2

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  • 2019 № 10 Requirements to internal control of quality and safety of medical activity according to the Оrder of Ministry of health of the Russian Federation of 07.06.2019 № 381n: how to ensure coordination of work of system on internal control and the medical commission

    In the article the authors emphasize the importance of the Requirements for the organization and conduct of internal control of quality and safety of medical activities, approved by the order of the Ministry of health of the Russian Federation of 07.06.2009 № 381n, in terms of ensuring continuity between the content of internal control of quality and safety of medical activities, on the one hand, and the directions of state and departmental control of quality and safety of medical activities, on the other hand. The publication details and substantiates the mechanisms of interaction on internal control between the Commission (service) on internal control and the medical Commission of the medical organization.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: authorized person on quality and safety of medical activity1 commission (service) on internal control1 control of quality and safety of medical activity1 internal control7 medical commission5

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  • 2019 № 6 Control purchase when providing paid medical services: what medical organizations must know

    The article deals with changes in legislation relating to the test purchase in order to verify compliance with the medical organization of the order and conditions of paid medical services. It is emphasized that control purchases in the provision of paid medical services is now one of the areas of state control of quality and safety of medical activity. The authors present the characteristics of the control purchase in conjunction with other forms and methods of control, including unscheduled inspections and control without interaction with legal entities, individual entrepreneurs. It is noted that the control purchase in the provision of paid medical services can be used by the relevant Supervisory authorities not only in the implementation of state quality control and safety of medical activities, but also in the implementation of supervision in the field of consumer protection, as well as in the implementation of the Federal state sanitary and epidemiological surveillance.
    Keywords: control purchase,  paid  medical  services,  medical  organization,  control  without  interaction  with  legal  entities,  unscheduled  on-site  inspections,  quality  control  and  safety  of  medical  activities,  separate  types  of  state  control  (surveillance)
    … Р. 6-10
    Abstract. The article deals with changes in legislation relating to the test purchase in order to verify compliance with the medical organization of the order and conditions of paid medical services. It is emphasized that control purchases in the provision of paid medical services is now one of the areas of state control of quality and safety of medical activity. The authors present the characteristics of the control purchase in conjunction with other forms and methods of control, including unscheduled inspections and control without interaction with legal entities, individual entrepreneurs. It is noted that the control purchase in the provision of paid medical services can be used by the relevant Supervisory authorities not only in the implementation of state quality control and safety of medical activities, but also in the implementation of supervision in the field of consumer protection, as well as in the implementation of the Federal state sanitary and epidemiological surveillance.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: control  without  interaction  with  legal  entities1 control purchase2 medical organization48 paid medical services17 quality  control  and  safety  of  medical  activities3 separate  types  of  state  control  (surveillance)1 unscheduled  on-site  inspections1

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  • 2018 № 9 Does the right health professional to work as a chief physician or his deputy?

    The article provides a detailed legal analysis of the formulation of one of the most important licensing requirements for the presence of a certificate(s) of the head (Deputy head) of a medical organization. The authors provide an unambiguous interpretation of this license requirement, which is that the presence of a certificate of a specialist in the specialty “health care organization and public health”, in the presence of the necessary length of service, gives the doctor the right to fill the position of the head (Deputy head) of a medical organization, regardless of the presence or absence of a certificate of a specialist in any other specialty

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: deputy heads of a medical organization1 health organization and public health1 licensing requirements2 manager of a medical organization1 qualification requirements2

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  • 2018 № 8 Duties of the doctors and the quality control and safety of medical activity: what to consider in a medical organization

    The article deals with the issues of registration and content of duties of a doctor in connection with the implementation of the state control of quality and safety of medical activities on checklists (lists of control issues). The authors pay attention to the direct requirement of the legislation in the field of health care, concerning the obligatory presence of job descriptions of doctors, as well as justify in detail where and how the medical organization should be prescribed job duties and duties of a doctor. The article shows that in the duties of a doctor it is necessary to document the provisions on compliance with the requirements for ensuring the quality and safety of medical activity.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: doctor’s duties1 doctor’s job duties1 employment contract4 job descriptions2 quality and safety of medical activity10

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  • 2018 № 5 Checklists of healthcare quality control and safety of medical activity: new challenges of medical organizations

    The article substantiates the necessity of analysis and careful study by medical organizations Of checklists (lists of control issues), approved by the order of Roszdravnadzor of December 20, 2017 № 10450. To this end, the authors propose to identify in the test sheets four conditional groups of control issues that have certain features that need to be considered by medical organizations. The article contains a reasonable conclusion that the analysis and careful study of the test sheets should be pre-determined by medical organizations as a mandatory component of internal quality control and safety of medical activities, ensuring its real continuity with the state control of quality and safety of medical activities

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: checklists1 lists of control questions1 medical organization48 quality and safety of medical activity10

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  • 2018 № 4 The role and importance of criteria for evaluating the quality of medical care, approved by order of ministry of health of Russia from 10.05.2017 n203n for healthcare organizations working in the mandatory health insurance system

    The article analyzes the regulatory framework governing the quality control of medical care in the system of mandatory health insurance (MHI) and the application of criteria for assessing the quality of medical care in a medical organization. It is noted that the criteria for assessing the quality of medical care are an integral tool for ensuring and controlling the quality of medical care for all medical organizations without exception, including those operating in the MHI system. The authors explain and emphasize that the legislation on compulsory medical insur¬ance in no way limits the use of these criteria medical organizations working in MHI. At the same time application of the specified criteria allows to prevent or reduce number of defects of medical care / violations at rendering medical care, and also number of defects of registration of primary medical documentation

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: control of the quality of medical care1 examination of the quality of medical care2 mandatory health insurance5 medical care11 medical organization48 quality assessment criteria1

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  • 2017 № 10 Criteria for assessing the quality of health care: what to consider and how to ensure compliance in a healthcare organization

    The issue deals with the organization of work on the application of criteria to assess the quality of care in a medical organization. The authors pay attention to a number of characteristics that must be taken into account specified criteria, including note that work on their application not only largely concerned, but also overlap with the functions of the medical Commission of the medical organization. The article shows that the use in a medical organization criteria for evaluating the quality of medical care is one of the tools that ensures the continuity of inter¬nal control of the quality and safety of medical activities with the departmental and state control of the quality and security of medical activity

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: criteria6 medical commission5 medical organization48 quality and safety of medical activity10 quality control3

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  • 2017 № 8 Standards of medical care: whether they are mandatory for compliance with medical organizations?

    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

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: inspections1 medical organization48 monitoring3 quality and safety of medical practice4 standards of medical care4

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  • 2017 № 7 The duty of medical organizations inform about the doctors: what is informing and how to organize it

    The article deals with the responsibility of medical organizations to provide information on doctors, their level of education and qualifications. Presented and substantiated list of specific information about doctors who have to post every medical organization on the official site in a network “the Internet”, as well as on the stands. The authors demonstrated that even if the doctor your consent to the placing of personal data (information about the doctor), which in accordance with legislation, obliged to submit medical organization, the placement of these data on its official site in a network “the Internet”, as well as on the stands should be continued. Stressed that the problem of placing medical organizations and maintaining up to date information about doctors, including their level of education and qualification, necessary water supply amount, and in strict accordance with the established requirements is one of the most important ways of ensuring and monitoring the quality and safety of medical activity

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: certificate of accreditation1 graduate certificate1 information about the doctor1 level of education and qualifications1 medical organization48 medical organization site1 personal data2 the quality and safety of medical practice1

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  • 2017 № 5 A new control tool in healthcare: a control without interacting with legal entities and individual entrepreneurs

    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.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: caution1 control without interaction with legal entities and individual entrepreneurs1 medical organization48 quality and safety of medical activity10 requirements1

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  • 2017 № 2 New tasks and directions of work of the medical commision in the system of providing and controlling the quality and safety of medical activities

    The article deals with the reasons of insufficiently work of medical commissions of medical organizations. It was noted that today the medical Commission, continuing to be the third level of quality control of medical care in medical organization, often is the third level of quality control and safety of medical activities. In the publication of the proposals to improve the efficiency of the medical Commission, including revealed the contents of its work in accordance with the objectives and functions set by law, which often remain outside the purview of heads of medical organizations.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: medical commission5 medical organization48 quality and safety of medical activities9 quality of medical care18 safety of medical activities2

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  • Focus of the problem
  • 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. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: federal state control (supervision)1 mandatory requirements2 medical organization48 quality and safety of medical activities9 supervisory authorities in the field of healthcare1

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  • 2020 № 9 On the implementation of certain “medical” amendments to the constitution of the Russian Federation

    The article suggests legislative implementation of certain “medical” amendments to the Constitution of the
    Russian Federation. The authors propose to add two articles to the Federal law “on the basics of public health protection in the Russian Federation” dated 21.11.2011 N323-FZ. In one article, it is proposed to reveal and specify the
    content of the newly introduced in the Constitution of the Russian Federation concept “unified legal bases of the health
    care system”. Another proposed article reveals the forms and content of work on the coordination of health issues,
    again referred by the Constitution of the Russian Federation to the joint responsibility of the Russian Federation and the
    subjects of the Russian Federation. According to the authors, the proposed changes in legislation will allow to ensure
    in practice the proper implementation of “medical” amendments to the Constitution of the Russian Federation, which in
    turn will ensure the improvement of legal regulation of the organization and activities of health care, and strengthen its
    material and technical base.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: accessibility and quality of medical care1 coordination of health issues1 health care23 joint management1 legislation4 powers in the field of health protection1 public health protection1 quality and safety of medical activities9 unified legal framework of the health system1

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  • 2018 № 10 About terms and order of provision of information constituting a medical secret to the institution of inquiry and investigation, the court, on request of the prosecution and of the criminal-executive system

    The article shows and justifies which bodies in accordance with the legislation of the Russian Federation belong to the bodies of inquiry and investigation. The authors pay attention to a number of important features that need to be taken into account by medical organizations when working with requests for information constituting medical secrecy, the bodies of inquiry and investigation, the court, at the request of the Prosecutor’s office and the body of the penal system, as this activity is regulated not only by the legislation in the field of health, but also by regulatory legal acts regulating the activities of these bodies.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: inquiries of bodies of inquiry and investigation1 medical organization48 medical secrecy2 quality and safety of medical activity10 requests of bodies of prosecutor’s office1 requests of body of penal system1 requests of court1 rights of citizens2

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  • Law
  • 2016 № 8 Guarantee citizens‘ rights while using medical devices

    The article shows that in recent years the requirements in the sphere of medical products circulation not only increased in volume but also become more stringent. So it requires that medical organizations has to do targeting actions to improve the work to ensure the rights of citizens to use medical devices. It is proved that the rights of citizens in the use of medical devices has certain specifics. The proposed measures aimed at improving the provision of these rights of citizens and safety monitoring of medical devices.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: medical devices2 medical organization48 quality and safety of medical devices1 quality control and safety of medical practice1 rights of citizens2 safety monitoring of medical devices1

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  • 2016 № 5 Legal regulation of internal control of the quality and safety of medical activity

    The article shows and proves what the Federal legislation should be analyzed and used in medical organization in the field of internal control of the quality and safety of medical activity. Presents directions for internal control of quality and safety of medical activities with regard to regulation of each Federal legislation.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: internal control7 legislation4 medical organization48 quality and safety of medical activities9

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  • Management in health care
  • 2021 № 5 Methodology of creating Proposals (Practical recommendations) on the organization of internal quality control and safety of medical activity in medical organizations providing care in the profile of nephrology (renal replacement therapy)

    Until 2020 in the Russian Federation there were no general approaches to the quality and safety management system in dialysis centers, which take into account the specifics of the organization of centers and allow to minimize the risks of adverse events associated with the conduct of replacement renal therapy.
    An urgent problem of healthcare organization in the Russian Federation is the creation of a methodology for organizing internal control and approaches to building a quality and safety management system in dialysis units and dialysis centers.
    Purpose is to design and prove the effectiveness of practical recommendations for quality and safety of medical practice in organizations providing care in the field of nephrology by methods of replacement kidney therapy.
    M a t e r i a l s a n d m e t h o d s . Methodology of creation of a system of internal control of quality and safety of medical activity is based on practical recommendations for the organization of internal control of quality and safety of medical activity in a polyclinic and in a hospital.
    R e s u l t s . On September 29, 2020, experts of FGBU “National Institute of Quality” of Roszdravnadzor assessed the system of organization and implementation of internal control of quality and safety of medical activity in separate subdivision № 1 of “B. Brown Avitum Russland Clinics” LLC in Saint Petersburg (Nevsky Nephrological Center).
    According to evaluation results experts made a unanimous decision on correspondence of the system of internal control of quality and safety of medical activity of “B. Braun Avitum Russland Clinic” LLC to standards of the system of voluntary certification “Quality and Safety of Medical Activity”.
    The cooperation of B. Braun Avitum Russland Clinic LLC and FGBU “National Institute of Quality” of Roszdravnadzor resulted in the development and successful practical application of propositions (Practical Recommendations) on the organization of internal control of quality and safety of medical activity in medical institutions providing nephrological care (Renal Assisted Therapy).
    F i n d i n g s . The proposed methodology has proved its practical orientation and can be used in medical organizations irrespective of their geography, size and form of property.

    Authors: Ivanov I. V. [25] Shvabsky O. R. [1] Shilo V. Y. [1] Moshchev A. N. [1] Gogoleva M. N. [1] Minulin I. B. [1]

    Tags: dialysis center1 dialysis unit1 esrd1 hemodialysis1 internal quality control1 nephrology care1 renal replacement therapy2 safety of medical care1 water for hemodialysis1

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  • 2018 № 1 About the requirements of the identification and design of preliminary and clinical diagnoses: what you need to pay attention in a medical organization

    The article discusses issues related to the organization of the identification and registration of clinical and preliminary diagnoses in accordance with the requirements of order of Ministry of Public Health from 10.05.2017 № 203н. Practical recommendations for filling approved by the Ministry of the Russian Federation of forms of medical documents (medical card of a patient receiving medical care in outpatient facilities, and medical card of the inpatient), taking into account new requirements for the establishment and design of the preliminary and clinical diagnoses. Brought to the attention of healthcare leaders that we now have a criterion of quality of medical care is the fulfillment of the requirements for the compulsory consultation of doctors in case of difficulty of establishing a clinical diagnosis within the specified time

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: clinical diagnosis1 criteria for evaluating quality1 doctors6 monitoring of quality of care1 preliminary diagnosis1 quality and safety of medical activity10

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  • Manager of health care consults
  • 2019 № 9 Work with appeals of citizens and satisfaction of separate requirements of the consumer: what to consider medical organizations

    The article deaths with the features of working with citizens and to meet the individual requirements of the consumer, which are required to know medical organizations. The authors show and justify under what conditions the consumer’s demand is a citizen’s appeal, as well as how the terms of consideration of citizens ‘ appeals and the terms of satisfaction of individual consumer requirements are correlated with each other. In the article it is noted that in the medical organization work with citizens‘ appeals should be an integral component of ensuring and controlling the quality and safety of medical activities.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: citizens‘ appeals1 consumer requirements1 control issues1 medical organization48 quality  control  and  safety  of  medical  activities3

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  • 2019 № 2 How to arrange the provision of paid medical services anonymously

    he article proposes specific mechanisms for the implementation of the right of patients to receive paid medical services anonymously. The authors propose and justify the use in the provision of paid medical services anonymously as the patient’s name alias (fictitious name), which should be reflected in the documentation – in the contract, the patient’s medical record, informed voluntary consent to medical intervention, etc. The Implementation of the proposals expressed by the authors of the article will allow to provide medical care anonymously in compliance with all the requirements of the law.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: citizen’s name1 medical organization48 paid medical services17 patient10 patient’s rights1 provision of paid medical services anonymously1 pseudonym (fictitious name)1

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  • Quality of health care management
  • 2016 № 6 Order for examination of quality of medical care

    The article deals with the factors that must be considered when establishing the order of examination of quality of medical care in the Russia with the exception of medical assistance provided in accordance with the Russian legislation on mandatory medical insurance. Analyzed and systematized information on the powers of constituent entities of control of quality and safety of medical activities in feald of examination of quality of medical care. Subject to the authority of constituent entities of control of quality and safety of medical activities proposed to allocate external and internal examination of quality of medical care. The content of examination of quality of medical care carried out by medical organizations.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: examination of quality of medical care1 medical activity5 medical organization48 quality control and safety of medical activity2 the expert of quality of medical care1

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  • Special opinion
  • 2020 № 7 Legal regulation of involuntary hospitalization of persons with coronavirus infection what needs to be done

    The article presents an analysis of legal acts regulating the procedure for hospitalization and / or isolation in cases of
    coronavirus infection. It is shown that currently, in accordance with the law, medical intervention is allowed without the consent of a citizen in respect of persons suffering from diseases that pose a danger to others. At the same time, the authors prove that the concepts of “medical intervention” and “hospitalization” are not identical. In turn, the legislation does not provide for involuntary hospitalization and involuntary isolation of persons suffering from diseases that pose a danger to others. The lack of clear legal regulation of these issues makes it difficult to implement effective measures to prevent the spread of coronavirus infection. The article proposes to define and legislate the procedure for involuntary hospitalization and involuntary isolation in cases of diseases that pose a danger to others.

    Authors: Piven D. V. [50] Kitsul I. S. [50] Ivanov I. V. [25]

    Tags: citizens‘rights1 coronavirus  infection5 diseases that pose a danger to others1 involuntary hospitalization1 isolation1 medical intervention1 medical organizations21 quality and safety of medical activities9

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