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The document ceased to be valid since July 1, 2021 according to Item 2 of the Order of the Government of the Russian Federation of June 29, 2021 No. 1048

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

(as amended on 17-06-2020)

According to article 88 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" Government of the Russian Federation decides:

Approve the enclosed Regulations on the state quality control and safety of medical activities.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of November 12, 2012 No. 1152

Regulations on the state quality control and safety of medical activities

1. This Provision determines procedure for the organization and carrying out the state quality control and safety of medical activities (further - the state control).

1(1). This Provision does not extend to the foreign legal entities and individual entrepreneurs performing 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.

2. Tasks of the state control are the prevention, identification and suppression of violation by public authorities and local government bodies, state non-budgetary funds, and also performing medical and pharmaceutical activities by the organizations and individual entrepreneurs of the requirements to quality assurance and safety of medical activities established by the legislation of the Russian Federation on protection of public health (further - mandatory requirements), and acceptance of stipulated by the legislation measures of the Russian Federation for suppression and (or) elimination of consequences of violation of mandatory requirements.

3. The state control is exercised in the way:

a) conducting checks of observance by public authorities and local government bodies, state non-budgetary funds, and also performing medical and pharmaceutical activities by the organizations and individual entrepreneurs of the rights of citizens in the sphere of protection of public health, including availability to disabled people of infrastructure facilities and the provided services in the specified sphere;

b) implementation of licensing of medical activities in accordance with the legislation of the Russian Federation about licensing of separate types of activity;

c) conducting checks of application by the organizations performing medical activities and individual entrepreneurs of procedures for delivery of health care and standards of medical care;

d) conducting checks of observance by the organizations performing medical activities and individual entrepreneurs of procedures for conducting medical examinations, medical examinations, medical examinations and medical surveys;

e) conducting checks of observance by the organizations performing medical activities and individual entrepreneurs of requirements for safe application and operation of medical products and to their utilization (destruction);

e) conducting checks of observance by health workers, heads of the medical organizations, pharmaceutical workers and heads of the pharmaceutical organizations of the restrictions applied to specified persons when implementing professional activity according to the Federal Law "About Bases of Protection of Public Health in the Russian Federation";

g) conducting checks of the organization and implementation:

federal executive bodies and executive bodies of subjects of the Russian Federation stipulated in Article 89 Federal Laws "About Bases of Protection of Public Health in the Russian Federation" of departmental quality control and safety of medical activities of bodies and organizations subordinated to them;

the federal executive bodies, executive bodies of subjects of the Russian Federation and local government bodies performing powers in the sphere of protection of public health, and also performing medical activities by the organizations and individual entrepreneurs the stipulated in Article 90 Federal Laws "About Bases of Protection of Public Health in the Russian Federation" of internal control of quality and safety of medical activities;

h) carrying out test purchases for the purpose of observance check by the organizations performing medical activities and individual entrepreneurs of procedure and conditions of provision of paid medical services.

4. The state control is exercised by the following state control bodies:

a) regarding conducting the checks and test purchases provided by subitems "a", "v" - "z" Item 3 this provision, - the Federal Service on supervision in health sector;

b) regarding the licensing of medical activities provided by the subitem "b" of Item 3 this provision - the Federal Service on supervision in health sector and executive bodies of subjects of the Russian Federation according to the Regulations on licensing of medical activities (except for the specified activities performed by the medical organizations and other organizations entering private health care system, in the territory of the innovative center "Skolkovo") approved by the order of the Government of the Russian Federation of April 16, 2012 N 291;

c) ceased to be valid.

5. When implementing the state control carrying out concerning one legal entity or the individual entrepreneur by various state control bodies of checks of observance of the same mandatory requirements is not allowed.

6. The state control regarding conducting the checks and test purchases provided by subitems "a", "v", "g", "e" - "z" Item 3 this provision, is performed by the following officials of the Federal Service on supervision in health sector and its territorial authorities:

a) the head of the Federal Service on supervision in health sector, his deputies;

b) heads of structural divisions of the Federal Service on supervision in health sector, their deputies whose official regulations provide powers on implementation of the state control;

c) other government civil servants of the Federal Service on supervision in health sector whose official regulations provide powers on implementation of the state control;

d) the head of territorial authority of the Federal Service on supervision in health sector, his deputies;

e) heads of structural divisions of territorial authority of the Federal Service on supervision in health sector, their deputies whose official regulations provide powers on implementation of the state control;

e) other government civil servants of territorial authority of the Federal Service on supervision in health sector whose official regulations provide powers on implementation of the state control.

6(1). The Federal Service on supervision in health sector exercises the state control using risk - the oriented approach, except for the licensing of medical activities provided by the subitem "b" of Item 3 this provision.

7. Provisions of the Federal Law "About Protection of the Rights of Legal Entities and Individual Entrepreneurs when Implementing the State Control (Supervision) and Municipal Control" and the Federal Law "About Bases of Protection of Public Health in the Russian Federation" are applied to the relations connected with implementation of the state control, the organization and conducting checks of the corresponding legal entities and individual entrepreneurs.

8. Terms and the sequence of accomplishment of ministerial procedures when implementing the state control are established by the administrative regulations of execution of the state functions developed and approved according to the order of the Government of the Russian Federation of May 16, 2011 N 373.

9. The state control is exercised by means of scheduled and unscheduled documentary and (or) exit inspections according to the procedure, provided by the Federal Law "About Protection of the Rights of Legal Entities and Individual Entrepreneurs when Implementing the State Control (Supervision) and Municipal Control".

As the basis for carrying out unscheduled inspections by the Federal Service on supervision in health sector the indicators of risk of violation of mandatory requirements approved by the Ministry of Health of the Russian Federation are used.

9(1). The officials specified in Item 6 of this provision when conducting planned inspection shall use checking sheets (lists of control questions).

Use of checking sheets (lists of control questions) is performed when conducting planned inspection of all legal entities and individual entrepreneurs.

Checking sheets (lists of control questions) contain the questions mentioning the mandatory requirements shown to the legal entity and the individual entrepreneur which observance is the most significant from the point of view of non-admission of emergence of threat of damnification of life, to health of citizens.

The subject of scheduled inspection of legal entities and individual entrepreneurs is limited to the list of the questions included in checking sheets (lists of control questions).

10. Concerning the legal entities and individual entrepreneurs performing separate types of activity in health sector, scheduled inspections are carried out with the frequency established by the Government of the Russian Federation.

11. When conducting the checks provided by the subitem "an" of Item 3 this provision the following events are performed:

a) consideration of the documents and materials characterizing activities of the checked bodies, the organizations and individual entrepreneurs for observance of the rights of citizens in the sphere of protection of public health, including availability to disabled people of infrastructure facilities and the provided services in the specified sphere;

b) consideration of the documents and materials characterizing the organization of work on consideration of addresses of citizens;

c) assessment of observance of requirements of the legislation of the Russian Federation to placement and contents of information on the performed activities in the sphere of protection of public health;

d) examination of quality of the medical care provided to the patient.

12. When conducting the checks provided by the subitem "v" of Item 3 this provision the following events are performed:

a) consideration of the documents and materials characterizing the organization of work and delivery of health care according to requirements of procedures for delivery of health care and standards of medical care;

b) consideration and the analysis of claims of the citizens connected with rendering medical care to them, including containing data on failure to provide information on possibility of rendering medical services, availability of the medicines and medical products included in the standard of medical care;

c) survey of the buildings used when implementing medical activities, structures, constructions, rooms and the territories;

d) assessment of observance of procedures for delivery of health care, including in part:

requirements to the organization of organization activity (their structural divisions, doctors), individual entrepreneurs;

standards of equipment;

recommended regular standard rates;

e) assessment of observance of standards of medical care, including in part:

justification of purpose of the medical services having the average frequency of provision less 1, and also completeness of accomplishment of medical services with average frequency of provision of 1;

justification and the completeness of prescription of medicines implanted into human body of medical products, components of blood, clinical nutrition including specialized products of clinical nutrition;

e) examination of quality of the medical care provided to the patient.

13. When conducting the checks provided by the subitem "g" of Item 3 this provision the following events are performed:

a) consideration of the documents and materials characterizing the organization and conducting medical examinations, medical examinations and medical surveys;

b) observance assessment:

procedures for conducting the medical examinations, medical examinations and medical surveys including containing lists of surveys of specialists doctors and medical researches;

rules of entering of records into medical documentation when conducting medical examinations, medical examinations and medical surveys, and also registrations of their results.

14. When conducting the checks provided by the subitem "e" of Item 3 this provision the following events are performed:

a) consideration of the documents and materials characterizing the organization of the work directed to observance of restrictions, the stipulated in Clause 74 Federal Laws "About Bases of Protection of Public Health in the Russian Federation", including consideration:

agreements on performing clinical trials of medicines, clinical testing of medical products, and also on implementation by the health worker of pedagogical and (or) scientific activities;

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