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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of December 18, 2018 No. 1163

About approval of criteria by which the risk degree from implementation of economic activity on medical practice is estimated and frequency of holding planned actions of the state supervision (control) by the Ministry of Health is determined

According to part two of article 5 of the Law of Ukraine "About the basic principles of the state supervision (control) in the sphere of economic activity" the Cabinet of Ministers of Ukraine decides:

1. Approve criteria by which the risk degree from implementation of economic activity on medical practice is estimated and frequency of holding planned actions of the state supervision (control) by the Ministry of Health which are applied is determined.

2. Recognize invalid:

the resolution of the Cabinet of Ministers of Ukraine of October 16, 2014 "About approval of criteria by which the risk degree from implementation of economic activity on medical practice is estimated and is determined No. 543 frequency of implementation of planned actions of the state supervision (control) by the Ministry of Health" (The Official Bulletin of Ukraine, 2014, No. 85, the Art. 2400);

Item of 23 changes which are made to resolutions of the Cabinet of Ministers of Ukraine, approved by the resolution of the Cabinet of Ministers of Ukraine of December 18, 2017 No. 1103 (The Official Bulletin of Ukraine, 2018, No. 17, the Art. 573).

Prime Minister of Ukraine 

V. Groysman

Approved by the Resolution of the Cabinet of Ministers of Ukraine of December 18, 2018 No. 1163

Criteria by which the risk degree from implementation of economic activity on medical practice is estimated and frequency of holding planned actions of the state supervision (control) by the Ministry of Health is determined

1. Criteria by which the risk degree from implementation of economic activity on medical practice is estimated are:

the term of implementation of economic activity on medical practice;

type of medical care which is performed by the subject of managing;

observance by the subject of managing of requirements of the legislation during implementation of economic activity on medical practice;

results of kliniko-expert evaluation of quality of provision by the subject of managing of the medical care which is carried out within the last two-five years preceding planning period;

amount of specialties on which medical practice is performed;

the number of the unplanned events of the state supervision (control) held concerning the subject of managing within the last two-five years preceding planning period on the bases provided by paragraphs to the third, fifth seventh, ninth part one of article 6 of the Law of Ukraine "About the basic principles of the state supervision (control) in the sphere of economic activity".

2. Risks of approach of negative consequences from implementation of economic activity on medical practice are determined by form according to appendix 1.

3. The list of criteria by which the risk degree from implementation of economic activity on medical practice is estimated their indicators and the number of points on each indicator, frequency of implementation of actions of the state supervision (control) are determined by form according to appendix 2.

4. Reference of the subject of managing to one of three risk degrees is performed taking into account score, added by all criteria from implementation of economic activity on medical practice:

from 41 to 100 points - to high risk;

from 21 to 40 points - to average risk degree;

from 0 to 20 points - to insignificant risk degree.

5. Planned actions of the state supervision (control) in the sphere of implementation of economic activity on medical practice are performed concerning activities of subjects of managing which are carried to:

high risk - is not more often than once in two years;

average risk degree - is not more often than once in three years;

insignificant risk degree - is not more often than once in five years.

6. If by results of at least two last planned actions of the state supervision (control) the facts of violation of requirements of the legislation from implementation of economic activity on medical practice are not elicited, the following planned event of the state supervision (control) concerning such subject of managing is held not earlier than through the period established for the corresponding risk degree increased in time 1,5. The specified provision is not applied to the subjects of managing carried to high risk.

Appendix 1

to Criteria by which the risk degree from implementation of economic activity on medical practice is estimated and frequency of holding planned actions of the state supervision (control) by the Ministry of Health is determined

Risks of approach of negative consequences from implementation of economic activity on medical practice

Purposes of the state supervision (control)
(code)

Risk of approach of negative consequences from implementation of economic activity

Criteria by which the risk degree from implementation of economic activity is estimated and frequency of holding planned actions of the state supervision (control) is determined

event which contains risk of approach of negative consequences

negative consequence

1. Life and health of the person (About 1)

inadequate delivery of health care (services)

death of the person 

harm to health of the person

the term of implementation of economic activity on medical practice 

type of medical care which is performed by the subject of managing

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