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Registered by the

Ministry of Justice of Ukraine

November 29, 2012

No. 2001/22313

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of September 28, 2012 No. 751

About creation and implementation of medico-technological documents on standardization of medical care in system of the Ministry of Health of Ukraine

(as amended on 26-09-2018)

According to Items 5. 3, 5.4 Programs of economic reforms for 2010-2014 "Prosperous society, competitive economy, the effective state", Ukraine approved by the Presidential decree of April 27, 2011 No. 504, article 14-1 of Bases of the legislation of Ukraine about health care, item 4 of the Regulations on the Ministry of Health of Ukraine approved by the Presidential decree of Ukraine of April 13, 2011 No. 467, and for the purpose of ensuring single, modern, scientifically based approaches to development of medico-technological documents on standardization of medical care on the principles of evidential medicine of PRIKAZYVAYU:

1. Approve:

1.1. Technique of development and deployment of medical standards of medical care on the principles of evidential medicine which is applied.

1.2. Technique of development of the system of indicators of quality of medical care which is applied.

1.3. Regulations on the multidisciplinary working group on development of medical standards (the unified clinical protocols) of medical care on the principles of evidential medicine which are applied.

1.4. Regulations on the register of medico-technological documents on standardization of medical care which are applied.

2. Control of determination of subjects of medico-technological documents, forming of multidisciplinary groups, development and deployment of medico-technological documents on standardization of medical care is performed by Department of reforms and development of medical care, Management of quality control of medical services of the Ministry of Health of Ukraine, the state company "State Expert Centre of the Ministry of Health of Ukraine".

3. Determine responsible for maintaining the register of medico-technological documents, material and organizational and methodical ensuring training of members of multidisciplinary groups, information and methodical support of development of medico-technological documents of standardization of medical care on the principles of evidential medicine the state company "State Expert Centre of the Ministry of Health of Ukraine".

4. Control of implementation of developed medico-technological documents exercises Control of quality control of medical services of the Ministry of Health of Ukraine with the assistance of the state company "State Expert Centre of the Ministry of Health of Ukraine".

5. Determine responsible for implementation of monitoring of clinical indicators of quality of medical care the state company "State Expert Centre of the Ministry of Health of Ukraine".

6. To the head of department of quality control of medical services of the Ministry of Health of Ukraine Donchenko T. M. provide in accordance with the established procedure state registration of this order in the Ministry of Justice of Ukraine.

7. Recognize invalid Item 3 of the order of the Ministry of Health of Ukraine of July 27, 1998 as No. 226 "About approval of Temporary industry unified standards of medical technologies of diagnostiko-medical process of the stationary help to adult population in treatment-and-prophylactic institutions of Ukraine and Temporary standards of amounts of diagnostic testings, medical actions and criteria of quality of treatment of children" and the order of the Ministry of Health of Ukraine of September 27, 2010 No. 819 "About development, approbation and implementation of medico-technological standards and standard rates in the field of health care".

8. To impose control of execution of this order on the deputy minister O. Tolstanov.

9. This order becomes effective from the date of its publication.

Acting Minister

O. Tolstanov

Approved by the Order of the Ministry of Health of Ukraine of September 28, 2012 No. 751

Technique of development and deployment of medical standards of medical care on the principles of evidential medicine

I. General provisions

1.1. This Technique determines the mechanism of development and deployment of scientifically based medical standards and the unified clinical protocols of provision of medical care on the principles of evidential medicine for the purpose of quality assurance, availability and efficiency of medical care, on the basis of the principles of successor and continuity of provision, ordering and exception of duplication of medical interventions and procedures, use of medical technologies and medicines, with scientifically proved efficiency.

1.2. In this Technique terms are used in such values:

adaptation of clinical installation - process of the analysis of prototypes concerning their compliance to the domestic resource and regulatory base, sales opportunity in Ukraine and financial provision, the used terms and medical specialties, the list of the medicines allowed for use in Ukraine, other medical technologies and the equipment which comes to the end with reasons for the actions necessary for implementation of provisions of clinical installations with the high level of validity;

evidential medicine - bona, exact and conscious fide use of the best results of clinical trials for the choice of treatment of the specific patient;

clinical audit - process of improvement of quality of medical care by means of systematic check of the provided medical care with use of accurately formulated criteria and with the subsequent modification. Based on check and retrospective assessment of elements of structure, process and result of medical care the actions necessary for improvement of quality at the individual, collective or organizational levels are determined;

the clinical indicator of quality of medical care - quantitative or qualitative index concerning which there are proofs or consensus on its direct influence on quality of medical care; it is determined retrospectively;

clinical route of the patient - algorithm of movement of the patient on structural divisions of institution of health care (further - ZZ) (or various institutions of health care) which are involved in assistance in case of specific condition or disease;

clinical installation - the document containing the systematized provisions rather medical and the medico-public assistance, the methodologies of evidential medicine developed with use based on confirmation of their reliability and validity, and aimed at assistance to the doctor and the patient in adoption of the rational decision in various clinical situations;

the criterion of quality of medical care is certain result, the target objective of medical care;

medico-technological documents - the generalized name of clinical installations, standards of medical care, the unified clinical protocols of medical care, new clinical protocols of medical care;

methodology of development of clinical installations from line item of evidential medicine - complex of methodical, information and organizational actions which is based on systematic generalization of the scientific evidence obtained during high-quality clinical trials (in particular randomized controlled);

monitoring - periodic or continuous systematic process of information collection concerning effectiveness of clinical or not clinical activities, work or systems;

the new clinical protocol of medical care - the clinical installation chosen by the Ministry of Health of Ukraine for its application in the territory of Ukraine as the clinical protocol without passing of the procedure of its adaptation; determines process of delivery of health care in case of certain disease; affirms the Ministry of Health of Ukraine as the text of the new clinical protocol or the reference to the source of its placement or the publication;

assessment - systematic studying of influence on the researched object/process, and also research of implementation process of actions or their consequences for development of recommendations about the subsequent optimization of activities, to increase in its efficiency and effectiveness;

the systematic overview of clinical trials - effective scientific technology of identification and generalization of the interventions this about efficiency which allows to estimate suitability to generalization and reliability of results of clinical trials and to reveal data which are not approved;

the unified clinical protocol of medical care - the document which is developed based on clinical installation taking into account health care system opportunities, in the presence of the standard of medical care according to it; determines process of provision of medical care, amount and its results in case of certain disease and affirms the Ministry of Health of Ukraine.

1.3. Medico-technological documents are developed with respect for the principle many (boundaries) - disciplinary (further - multidisciplinary) approach on separate subject - medical problem (disease or other pathological condition, observance of healthy lifestyle), but not on medical specialty.

On certain subject are included in the package of medico-technological documents:

adapted clinical installation (basis);

standards of medical care which are developed in limited quantity according to health care system priorities for the most urgent medical problems;

the new clinical protocol of medical care which affirms by the choice of the clinical installation which is subject to application in the territory of Ukraine, its translation into Ukrainian or statement in English or in original language;

the unified clinical protocol of medical care is drafted on the basis of the standard of medical care (classical method) or on the basis of adapted clinical installation in the absence of the standard of medical care (the direct or reduced method).

Availability of two methods of development of the unified clinical protocol is caused by specific functions of the standard of medical care as organizational document which contains criteria of quality of medical care.

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