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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 29, 2021 No. 1048

About approval of the Regulations on federal state control (supervision) of quality and safety of medical activities

According to Item 1 of part 2 of article 3 of the Federal law "About the State Control (Supervision) and Municipal Control in the Russian Federation" and part 5 of article 87 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on federal state control (supervision) of quality and safety of medical activities.

2. Recognize invalid:

the order of the Government of the Russian Federation of November 12, 2012 No. 1152 "About approval of the Regulations on the state quality control and safety of medical activities" (The Russian Federation Code, 2012, No. 47, the Art. 6501);

Item of 3 changes which are made to acts of the Government of the Russian Federation, approved by the order of the Government of the Russian Federation of September 14, 2016 No. 923 "About introduction of amendments to some acts of the Government of the Russian Federation" (The Russian Federation Code, 2016, No. 38, the Art. 5567);

the order of the Government of the Russian Federation of July 5, 2017 No. 801 "About modification of the Regulations on the state quality control and safety of medical activities" (The Russian Federation Code, 2017, No. 28, the Art. 4170);

Item of 3 changes which are made to acts of the Government of the Russian Federation regarding establishment of obligation of use of checking sheets (lists of control questions) when conducting the planned inspections approved by the order of the Government of the Russian Federation of July 14, 2017 No. 840 "About introduction of amendments to some acts of the Government of the Russian Federation regarding establishment of obligation of use of checking sheets (lists of control questions) when conducting planned inspections" (The Russian Federation Code, 2017, No. 30, the Art. 4673);

the order of the Government of the Russian Federation of December 16, 2017 No. 1571 "About modification of the Regulations on the state quality control and safety of medical activities" (The Russian Federation Code, 2017, No. 52, the Art. 8148);

the order of the Government of the Russian Federation of November 30, 2018 No. 1447 "About modification of the Regulations on the state quality control and safety of medical activities" (The Russian Federation Code, 2018, No. 50, the Art. 7761);

Item of 3 changes which are made to acts of the Government of the Russian Federation, approved by the order of the Government of the Russian Federation of November 9, 2019 No. 1433 "About introduction of amendments to some acts of the Government of the Russian Federation" (The Russian Federation Code, 2019, No. 46, the Art. 6499);

Item of 2 changes which are made to Regulations on the Federal Service on supervision in health sector and Regulations on the state quality control and the safety of medical activities approved by the order of the Government of the Russian Federation of June 17, 2020 No. 866 "About modification of the Regulations on the Federal Service on supervision in health sector and Regulations on the state quality control and safety of medical activities" (The Russian Federation Code, 2020, No. 25, the Art. 3910).

3. From the date of entry into force of this resolution the scheduled inspections of legal entities and individual entrepreneurs included in the annual plan of the state quality control and safety of medical activities for 2021 and also scheduled and unscheduled inspections within the state quality control and safety of medical activities, the decision on which carrying out is made before entry into force of this resolution, are carried out according to the Provision approved by this resolution.

4. This resolution becomes effective since July 1, 2021, except for the paragraph of the tenth subitem "an" of Item 3 of the Provision approved by this resolution which becomes effective since January 1, 2022.

The paragraph the fourth the subitem "an" of Item 3 of the Provision approved by this resolution is effective till January 1, 2022.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of June 29, 2021 No. 1048

Regulations on federal state control (supervision) of quality and safety of medical activities

I. General provisions

1. This Provision establishes procedure for the organization and implementation of federal state control (supervision) of quality and safety of medical activities (further - the state control (supervision).

2. This Provision does not extend on foreign legal entities and foreign individual entrepreneurs who perform medical activities in the territory of the international medical cluster based on the allowing documentation issued in accordance with the established procedure by authorized bodies and the organizations of foreign state - organization member of economic cooperation and development and the medical activities confirming the right to implementation.

3. Subject of the state control (supervision) are:

a) observance by the medical organizations (including health workers), the pharmaceutical organizations (including pharmaceutical workers), Federal Compulsory Health Insurance Fund and territorial funds of compulsory medical education, the individual entrepreneurs performing medical activities and the individual entrepreneurs performing pharmaceutical activities, mandatory requirements in the sphere of health protection, requirements to the objects used when implementing activities in the sphere of health protection (further - controlled persons), including:

the rights of citizens in the sphere of health protection;

procedure for delivery of health care, regulations on the organization of delivery of health care by types of medical care, rules of carrying out laboratory, tool, pathoanatomical and other types of diagnostic testings, procedure for conducting medical examinations, medical examination, dispensary observation, medical examinations and medical surveys;

standards of medical care;

procedure and conditions of provision of paid medical services, except for the mandatory requirements carried to subject of federal state supervision in the field of consumer protection;

the restrictions imposed on health workers, heads of the medical organizations, pharmaceutical workers and heads of the pharmaceutical organizations when implementing of professional activity by them according to the Federal Law "About Bases of Protection of Public Health in the Russian Federation";

requirements to the organization and carrying out internal control of quality and safety of medical activities;

requirements to provision of social service, stipulated in Item 1 part 1 of article 6.2 of the Federal law "About the Government Public Assistance";

requirements to ensuring availability to disabled people of infrastructure facilities and the provided services in the sphere of health protection;

compliance to the medical care provided by health workers to quality criterions of medical care;

b) observance of licensed requirements when implementing medical activities.

4. The state control (supervision) is exercised by the Federal Service on supervision in health sector.

5. The officials authorized on implementation of the state control (supervision) are:

a) the head (deputy manager) of the Federal Service on supervision in health sector (territorial authority of the Federal Service on supervision in health sector);

b) officials of the Federal Service on supervision in health sector (territorial authority of the Federal Service on supervision in health sector) to whose job responsibilities according to official regulations implementation of powers on implementation of such type of control (supervision), including holding preventive actions and control (supervising) actions belongs (further - inspectors).

6. The inspectors authorized on holding specific preventive action or control (supervising) action are determined by the decision of regulatory (supervising) authority on holding preventive action or control (supervising) action.

7. The officials authorized on decision making about holding control (supervising) actions are:

a) the head of the Federal Service on supervision in health sector (territorial authority of the Federal Service on supervision in health sector);

b) the deputy manager of the Federal Service on supervision in health sector (territorial authority of the Federal Service on supervision in health sector).

8. The officials exercising the state control (supervision) when holding control (supervising) action within the powers and in volume of the carried-out control (supervising) actions have the rights established by part 2 of article 29 of the Federal law "About the State Control (Supervision) and Municipal Control in the Russian Federation".

9. Provisions of the Federal Law "About the State Control (Supervision) and Municipal Control in the Russian Federation" are applied to the relations connected with implementation of the state control (supervision).

10. The Federal Service on supervision in health sector exercises the state control (supervision) for:

a) activities of the medical organizations (including health workers), the pharmaceutical organizations (including pharmaceutical workers), Federal Compulsory Health Insurance Fund and territorial funds of compulsory medical insurance, the individual entrepreneurs performing medical activities and the individual entrepreneurs performing pharmaceutical activities;

b) results of activities of the medical organizations (including health workers), the pharmaceutical organizations (including pharmaceutical workers), Federal Compulsory Health Insurance Fund and territorial funds of compulsory medical insurance, the individual entrepreneurs performing medical activities and the individual entrepreneurs performing pharmaceutical activities, including activities for delivery of health care, conducting medical examinations, medical examinations, medical examinations and medical surveys to which mandatory requirements are imposed;

c) the objects used when implementing activities in the sphere of health protection including buildings, rooms, constructions and the equipment to which mandatory requirements are imposed.

11. Accounting of the objects of control specified in Item 10 of this provision (further - objects of control), is performed by means of collection, processing, the analysis and accounting of data on objects of control based on information containing in the unified register of licenses of the Federal Service on supervision in health sector according to regulatory legal acts, and also information obtained within interdepartmental interaction, and public information.

II. Risk management of damnification (damage) to the values protected by the law when implementing the state control (supervision)

12. The Federal Service on supervision in health sector for the purpose of risk management of damnification (damage) to the values protected by the law when implementing the state control (supervision) refers objects of control to one of the following categories of risk of damnification (damage) (further - categories of risk):

a) extremely high risk;

b) high risk;

c) significant risk;

d) average risk;

e) moderate risk;

e) low risk.

13. Reference of objects of control to certain category of risk is performed based on criteria of reference of activities of the legal entities and individual entrepreneurs performing medical activities to certain category of risk, according to appendix.

14. The following types of holding planned control (supervising) actions concerning objects of control depending on the appropriated category of risk and their frequency are established:

a) for category of extremely high risk - one of the following control (supervising) events:

inspection visit - once in calendar year;

exit check - once in calendar year;

test purchase - once in calendar year;

documentary check - once in calendar year;

b) for category of high risk - one of the following control (supervising) events:

inspection visit - once in 2 years;

exit check - once in 2 years;

test purchase - once in 2 years;

documentary check - once in 2 years;

c) for category of significant risk - one of the following control (supervising) events:

inspection visit - once in 3 years;

exit check - once in 3 years;

test purchase - once in 3 years;

documentary check - once in 3 years;

d) for category of average risk - one of the following control (supervising) events:

inspection visit - once in 5 years;

exit check - once in 5 years;

test purchase - once in 5 years;

documentary check - once in 5 years;

e) for category of moderate risk - one of the following control (supervising) events:

inspection visit - once in 6 years;

exit check - once in 6 years;

test purchase - once in 6 years;

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