All articles by Ivanov I. V.
-
2022 № 8 Professional standards: the role and importance in ensuring the quality and safety of medical activities, the main tasks
The article deals into detail with the application of professional standards in the activities of medical organizations and in the training of medical personnel. The authors substantiate that the application of professional standards in the regulation of labor relations of medical workers, as well as in the development and implementation of both professional educational programs and additional professional programs is an essential tool for ensuring the quality and safety of medical activities. The main tasks facing today in the field of the application of professional standards, the implementation of which will contribute to improving the quality and safety of medical activities, are identified: the creation of legal mechanisms for the effective application of professional standards by educational organizations; ensuring continuity in the application of professional standards between the training of medical personnel and the regulation of labor relations in the process of medical activity; the need to constantly maintain professional standards up to date
-
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. -
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.
-
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.
-
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.
-
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. -
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
-
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.
-
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
-
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
-
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
-
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
-
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
-
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. -
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.
-
2023 № 7 New rules of paid medical services: is a medical organization required to have an official website.
The Rules for the provision of paid medical services by medical organizations, approved by Government Decree No. 736 dated May 11, 2023, significantly expand the requirements that provide for an increase in the amount of information about the contractor and the paid medical services provided by him, which the medical provider must provide to the consumer. organization. Taking into account these requirements, the article considers in detail the question of whether medical organizations providing paid medical services are required to have their own official website. The authors substantiate that all medical organizations providing paid medical services, but not participating in the implementation of the State Guarantees Program, are required to post the information provided by law about themselves and about
the paid medical services they provide on the Internet. At the same time, the specified information may be posted on the official website on the Internet and (or) in other information systems on the Internet. At the same time, all medical organizations providing paid medical services must take into account the risks associated with the use of information systems owned by foreign legal entities and citizens, the use of which is subject to the prohibitions established by Part 8 of Art. 10 of the Federal Law “On Information, Information Technologies and Information Protection”. One way to account for these risks is to create or develop your own official sites on the Internet. -
2023 № 4 Problematic issues of contractual relations between a medical worker and a medical organization: what needs to be paid attention to the head of a medical organization and a medical worker
The “Guidelines for Compliance with Mandatory Requirements in Carrying Out Medical Activities” approved by Roszdravnadzor on November 11, 2022, noted that the most common violations include the licensee’s lack of employment contracts with employees performing work (services) permitted by the license. In this regard, the article substantiates in detail the need to conclude an employment contract with every medical worker working in a medical organization, regardless of whether this organization is his main place of work or not.
The authors show that when a medical organization engages a medical worker from another medical organization to consult patients on a regular basis, it is also necessary to conclude an employment contract with him. At the same time, when a medical organization engages a medical worker of another medical organization on a paid basis for one-time/separate consultations, a civil law contract can be concluded with him. The article emphasizes that the concepts of “consultant” and “medical consultation” require their disclosure in the legislation, which determine the legal status of specialists involved in consultations and give a detailed description of medical consultations. -
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.
-
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. -
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. -
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.
-
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.
-
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.
-
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. -
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
-
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.
-
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.
-
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.
-
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.