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 government of the Russian Federation decides:

Approve the enclosed changes which are made to the Regulations on the state quality control and safety of medical activities approved by 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, Art. 6501; 2016, No. 38, Art. 5567).

Approved by the Order of the Government of the Russian Federation of July 5, 2017 No. 801

Changes which are made to Regulations on the state quality control and safety of medical activities

1. Add with Item 6 (1) the following content:

"6(1). The Federal Service on supervision in the field of health care 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.".

2. Add with Items 19 - 29 following contents:

"19. For the purpose of application by the Federal Service on supervision in the field of health care risk - the oriented approach when implementing the state control activities of the legal entities and individual entrepreneurs performing medical activities (further - objects of the state control), are subject to reference to certain category of risk according to Rules of reference of activities of legal entities and individual entrepreneurs and (or) used by them production facilities to certain category of risk or certain class (category) of danger approved by the order of the Government of the Russian Federation of August 17, 2016 No. 806 "About application risk - the oriented approach under the organization of separate types of the state control (supervision) and introduction of amendments to some acts of the Government of the Russian Federation" (further respectively - Rules, category of risk).

20. Reference of objects of the state control to certain category of risk is performed based on criteria of reference of the objects of the state control to certain category of risk established according to appendix.

21. Reference of objects of the state control to certain category of risk is performed by the decision of the head (deputy manager) of the Federal Service on supervision in the field of health care about reference of objects of the state control to certain category of risk (further - the decision on reference of objects of the state control to certain category of risk) based on the criteria established by appendix to this Provision.

22. Conducting planned inspections concerning objects of the state control (depending on certain category of risk) is performed with the following frequency:

a) once in calendar year - for category of extremely high risk;

b) once in 2 years - for category of high risk;

c) once in 3 years - for category of significant risk;

d) not more often than once in 5 years - for category of average risk;

e) not more often than once in 6 years - for category of moderate risk.

23. Concerning the objects of the state control referred to category of low risk, scheduled inspections are not carried out.

24. The Federal Service on supervision in the field of health care keeps the list of objects of the state control which are referred to certain category of risk (further - the list). Inclusion of legal entities and individual entrepreneurs in the list is performed based on the decision on reference of objects of the state control to certain category of risk.

25. The list contains the following information:

a) full name of the legal entity and surname, name and middle name (in the presence) individual entrepreneur;

b) primary state registration number;

c) individual taxpayer number;

d) location and place of implementation of activities of the legal entity and individual entrepreneur;

e) details of the decision on assignment to object of the state control of category of risk, specifying on category of risk, and also the data based on which the decision on reference of object of the state control to certain category of risk was made.

26. On the official site of the Federal Service on supervision in the field of health care on the Internet the following information on the objects of the state control referred to categories extremely high containing in the list high is posted and supported in urgent condition and considerable it is risk:

a) full name of the legal entity and surname, name and middle name (in the presence) individual entrepreneur;

b) primary state registration number;

c) individual taxpayer number;

d) place of implementation of activities of the legal entity and individual entrepreneur;

e) category of risk and decision date about reference of object of the state control to certain category of risk.

27. Placement of information specified in Item 26 of this provision is performed taking into account requirements of the legislation of the Russian Federation about the state secret.

28. The Federal Service on supervision in the field of health care submits within the term established by Rules at the request of the legal entity and the individual entrepreneur information on the category of risk appropriated to objects of the state control, and also data used for reference of objects of the state control to certain category of risk.

29. The legal entity and the individual entrepreneur has the right to submit in the procedure established by Rules to the Federal Service on supervision in the field of health care the statement for change of the activities of category of risk appropriated earlier them.".

3. Add with appendix of the following content:

"Appendix

to Regulations on the state quality control and safety of medical activities

Criteria of reference of activities of the legal entities and individual entrepreneurs performing medical activities to certain category of risk

I. General provisions

1. When implementing the state control reference of activities of the legal entities and individual entrepreneurs performing medical activities (further - objects of the state control), to certain category of risk is performed according to criteria of weight of potential negative effects of possible non-compliance with mandatory requirements according to the Section II of this document and taking into account criteria of possible non-compliance with mandatory requirements according to the Section III of this document.

2. Reference of objects of the state control to certain category of risk is performed taking into account information containing in the unified register of licenses for implementation of medical activities which maintaining is performed by the Federal Service on supervision in the field of health care.

II. Criteria of weight of potential negative effects of possible non-compliance with mandatory requirements

3. Objects of the state control taking into account weight of potential negative effects and probability of non-compliance with the mandatory requirements expressed in the hazard rate To determined according to Items 5 and 6 of this document by them (further - hazard rate To), are subject to reference to the following categories of risk:

a) extremely high risk - if hazard rate To makes over 453900;

b) the high risk - if hazard rate To makes from 280901 to 453900;

c) the great risk - if hazard rate To makes from 172301 to 280900;

d) the average risk - if hazard rate To makes from 89101 to 172300;

e) the moderate risk - if hazard rate To makes from 21300 to 89100;

e) the low risk - if hazard rate To makes less than 21300.

4. The hazard rate To for object of the state control is determined by summing of measure value of risk, appropriated to the works (services) constituting medical activities performed by object of the state control taking into account types of medical care and conditions of its rendering.

5. The hazard rates appropriated to works (services) constituting medical activities taking into account types and conditions of delivery of health care are given according to appendix.

III. Criteria of possible non-compliance with mandatory requirements

6. The objects of the state control which are subject to reference according to the Section II of this document to categories high, considerable, average moderate and low it is risk, are subject to reference to categories extremely high, high, considerable, average and moderate it is risk respectively in the presence of taken legal effect within 2 years preceding decision date about reference of object of the state control to certain category of risk, the resolution on administrative prosecution with purpose of administrative punishment in the form of administrative penalty to the legal entity, his officials, the individual entrepreneur for making of the administrative offense provided by part 21 of article 19.5 of the Russian Federation Code of Administrative Offences.

7. The objects of the state control referred to categories extremely high, high, considerable average and moderate it is risk, are subject to reference to categories high, considerable, average, moderate and low it is risk respectively in case of absence within 2 years preceding decision date about reference of object of the state control to certain category of risk, resolutions on administrative prosecution with purpose of administrative punishment to the legal entity, his officials, the individual entrepreneur for making of the administrative offense specified in Item 6 of this document.

Appendix

to criteria of reference of activities of the legal entities and individual entrepreneurs performing medical activities to certain category of risk

The hazard rates appropriated to works (services) constituting medical activities taking into account types and conditions of delivery of health care

 

Works (service) constituting medical activities		Hazard rates
I. The works (service) constituting medical activities, organized and which are carried out when rendering primary, including pre-medical, medical and specialized, medical and sanitary assistance
1.	When rendering primary pre-medical medical and sanitary help in out-patient conditions
	on obstetric case	356
	on anesthesiology and resuscitation	445
	on bacteriology	178
	on vaccination (carrying out preventive inoculations)	312
	on hygiene in stomatology	45
	on hygienic education	45
	on histology	178
	on dezinfektologiya	178
	on laboratory case	178
	on laboratory diagnostics	223

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