of October 16, 2014 No. 543
About approval of criteria by which the risk degree from implementation of economic activity on medical practice is estimated and frequency of implementation of 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 implementation of planned actions of the state supervision (control) by the Ministry of Health which are applied is determined.
2. Bring in appendix to the resolution of the Cabinet of Ministers of Ukraine of September 10, 2008 No. 843 "About approval of criterion on which the risk degree from implementation of activities in health sector for safety of life and health of the population is estimated and frequency of implementation of planned actions of the state supervision (control) is determined" (The Official Bulletin of Ukraine, 2008, No. 72, Art. 2427; 2011, No. 84, Art. 3060), following changes:
The subitem 1 of Item 1 to exclude 1);
Paragraph two of Item 3 to exclude 2).
Prime Minister of Ukraine
A. P. Yatsenyuk
Approved by the Resolution of the Cabinet of Ministers of Ukraine of October 16, 2014 No. 543
1. Treat criteria by which the risk degree from implementation of economic activity on medical practice is estimated:
the term of implementation of economic activity on medical practice;
availability of violations of requirements of the legislation in the sphere of health protection;
type of medical care (emergency, primary, secondary (specialized), tertiary (highly specialized), palliative, medical rehabilitation).
2. According to the established criteria subjects of managing which perform economic activity on medical practice belong to one of three risk degrees - high, average or insignificant.
3. Subjects of managing treat high risk:
term of implementation of economic activity on which medical practice constitutes less than three years irrespective of type of medical care;
which within the last two years previous planned, but it is at least as by results of two last actions of the state supervision (control) allowed violation of requirements of the legislation in the sphere of health protection.
4. Subjects of managing treat average risk degree:
term of implementation of economic activity on which medical practice constitutes from three to five years irrespective of type of medical care;
which within the last three years previous planned, but it is at least as by results of two last actions of the state supervision (control) allowed violation of requirements of the legislation in the sphere of health protection.
5. Subjects of managing with insignificant risk degree:
term of implementation of economic activity on which medical practice constitutes of five years and more irrespective of type of medical care;
which within the last three years previous planned, but it is at least as by results of two last actions of the state supervision (control) did not allow violations of requirements of the legislation in the sphere of health protection.
6. Planned actions of the state supervision (control) of activities of subjects of managing are performed with the following frequency:
with high risk - is not more often than once in two years;
with average risk degree - is not more often than once in three years;
with insignificant risk degree - is not more often than once in five years.
7. If the subject of managing can be carried at the same time to two or more risk degrees, such subject belongs to more high risk.
8. If by results of planned and unplanned actions of the state supervision (control) (in the presence) within the last six years for subjects of managing which are carried to average risk degree and within the last ten years for subjects of managing which are carried to insignificant risk degree, at the subject of managing violations of requirements of the legislation concerning implementation of economic activity on medical practice are not revealed, the following planned event of the state supervision (control) concerning such subject of managing is held not earlier than through the period of time established for the corresponding risk degree, increased in time 1,5.
If from the date of adoption of such decision by results of unscheduled inspections violations by the subject of managing of requirements of the legislation in the respective sphere are revealed, the following planned event of the state supervision (control) concerning such subject of managing is performed in the next planning period.
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The document ceased to be valid since January 4, 2019 according to Item 2 of the Resolution of the Cabinet of Ministers of Ukraine of December 18, 2018 No. 1163