ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of November 30, 2012 No. 981

About introduction of amendments to the order MZ of Ukraine of February 02, 2011 No. 49

According to articles 6 and 9 of the Law of Ukraine "About licensing of certain types of economic activity" and according to subitem 6.48 of the subitem 6 of 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, I ORDER:

1. Make changes to the Licensed conditions of maintaining economic deyatelnostfya on medical practice (with changes) approved by the order of the Ministry of Health of Ukraine of February 02, 2011 No. 49, registered on February 09, 2011 for No. 171/18909, having been reworded as follows them which are applied the Ministry of Justice of Ukraine.

2. To provide to the head of department of quality control of medical services T. Donchenko:

2.1. Submission of this order in accordance with the established procedure on state registration in the Ministry of Justice of Ukraine.

2.2. The publication of this order in mass media.

3. To impose control over the implementation of this order on the deputy minister O. Tolstanov.

4. This order becomes effective in ten days from the date of its official publication.

 

Approved by the Order of the Ministry of Health of Ukraine of February 2, 2011 No. 49

(in edition of the Order of the Ministry of Health of Ukraine of November 30, 2012 No. 981)

Licensed conditions of conducting economic activity on medical practice

I. General provisions

1.1. These Licensed conditions are developed according to Bases of the legislation of Ukraine on health care, the Laws of Ukraine "About medicines", "About licensing of certain types of economic activity" and establish qualification, organizational and other requirements for conducting medical practice.

1.2. Action of these Licensed conditions extends to all subjects of managing who are registered in accordance with the established procedure, irrespective of their form of business and pattern of ownership which conduct economic activity on medical practice.

1.3. The term "medical practice" in these Licensed conditions has such value - type of economic activity in the field of health care which is conducted by institutions of health care and physical persons - entrepreneurs who meet single qualification requirements, for the purpose of provision of the types of medical care determined by the law and medical attendance.

Other terms are used in the values determined by Bases of the legislation of Ukraine on health care.

1.4. Subjects of managing for receipt of the license, renewal of the license, receipt of the copy of the license, cancellation of the license, receipt of the duplicate of the license and the message on change of data in documents which were enclosed to the application for licensing represent to the Ministry of Health of Ukraine (further - MZ of Ukraine) documents, the stipulated in Article 10 Laws of Ukraine "About licensing of certain types of economic activity", the resolution of the Cabinet of Ministers of Ukraine of July 04, 2001 to No. 756 "About approval of the list of documents which are enclosed to the application for licensing for separate type of economic activity" and appendices 1-7 to these Licensed conditions.

II. Organizational requirements

2.1. When conducting economic activity on medical practice the licensee shall adhere to requirements:

Laws of Ukraine, in particular:

Bases of the legislation of Ukraine on health care;

"About licensing of certain types of economic activity";

"About ensuring sanitary and epidemic wellbeing of the population";

"About the emergency medical care";

"About protection of the person against impact of ionizing radiation";

"About protection of the population against infectious diseases";

"About counteraction to spread of the diseases predetermined by the human immunodeficiency virus (HIV), both legal and social protection of people who live with HIV" } {HIV), both legal and social protection of people who live with HIV";

"About medicines";

"About drugs, psychotropic substances and precursors";

"About actions of counteraction to the illegal address of drugs, psychotropic substances and precursors and to abuse of them";

"About mental health services";

"About organ transplantation and other anatomic materials to the person";

"About donorship of blood and its components";

"About the basic principles of the state supervision (control) in the field of economic activity" } {control) in the field of economic activity";

"About ratification of the Convention on transfer of persons who suffer from mental disturbances, for performing forced treatment";

"About improvement and rest of children";

"About rehabilitation of disabled people in Ukraine";

"About counteraction with disease of tuberculosis";

"About personal data protection";

resolutions of the Cabinet of Ministers of Ukraine, including the resolution of the Cabinet of Ministers of Ukraine of July 15, 1997 No. 765 "About approval of the Procedure for the state accreditation of institution of health care";

regulatory legal acts MZ of Ukraine concerning the organization and provision of medical care to the population and ensuring sanitary and epidemic wellbeing of the population, concerning radiation safety, and also concerning the activities connected with the organization and quality of provision of medical care to the population.

2.2. Medical practice is conducted by subjects of managing based on the license on condition of accomplishment of the qualification, organizational, other special requirements established by these Licensed conditions.

Subjects of managing shall provide control of quality of provision of medical care.

Subjects of managing which conduct economic activity on medical practice shall approve the list and cost of services which according to the legislation are provided to patients.

Medical care is provided by subjects of managing by the types of medical care determined by Bases of the legislation of Ukraine on health care.

Use of one office in which medical practice is conducted on different functional purposes is not allowed.

Joint use of rooms (offices) by different subjects of managing for conducting medical practice shall be confirmed by employment contracts, lease (sublease) and the relevant documents (acts).

2.3. Medical equipment and products of medical appointment are used by subjects of managing in medical practice only after their state registration.

2.4. In medical practice subjects of managing can apply the methods of prevention, diagnostics, treatment, rehabilitation and medicines allowed for use by MZ of Ukraine.

2.5. The licensee shall place on place of business on medical practice in the place, available to the consumer, reliable information, in particular:

sign with indication of the name of the subject of managing or surname, name, middle name of the physical person - the entrepreneur according to entry in the Unified State Register of Legal Entities and physical persons - entrepreneurs (the daleeediny state register) and operating mode;

the copy of the license and the copy of the statement from the Unified state register, the accreditation certificate of institution of health care (on condition of functioning more than two years);

the list of medical and provisional specialties and professions of junior specialists with medical and pharmaceutical education on which medical practice is conducted;

copy of the certificate on certification of laboratory (in the presence);

the list and cost of services which according to the legislation are provided to patients;

data on management (surname, name, middle name of the head, his deputies) and doctors of the licensee (surnames, names, middle names, positions, categories);

visitors book of citizens.

2.6. Medical practice is conducted by subjects of managing based on the license and under condition:

availability of rooms which satisfy to the established sanitary standards and rules;

availability of devices, the equipment, equipment according to the sheet of equipment by products of medical purpose of medical and diagnostic offices of out-patient and polyclinic institutions, stationary departments of hospitals (далееТабель equipment). At the same time means of the measuring equipment shall be metrological confided;

completeness workers (doctors, pharmacists, junior specialists with medical and pharmaceutical education) for conducting economic activity on medical practice according to the Section III of these Licensed conditions;

observance of requirements concerning certification of health workers and pharmaceutical workers;

passings by health and pharmaceutical workers of obligatory medical examinations;

availability of entrance and conditions for open entry of persons physically challenged.

2.7. The institution of health care shall:

a) approve in the procedure established by the legislation:

the charter (provision), structure, the staff list, the list of the equipment according to the Sheet of equipment of institution of health care;

nomenclature of cases on medical and pharmaceutical documentation;

job descriptions for workers of institution of health care;

rules of stay of patients in health care institution;

the list of means of the measuring equipment which are in operation and are subject to metrological checking;

standards of sisterly (medical) leaving;

rules and instructions of accomplishment of manipulations and procedures;

regulations on structural divisions;

local clinical protocols (routes of patients) according to the clinical protocols and medical standards approved by MZ of Ukraine;

information on operations procedure in case of immediate conditions;

rules and instructions about order of interaction of structural division with other structural divisions of institution of health care and/or other institutions of health care;

the instruction concerning rules of sink and disinfecting of hands;

internal control of quality of provision of medical care;

b) adhere:

the labor law concerning employment and the admission to medical practice of health and pharmaceutical workers;

regulatory legal acts concerning stay of patients in health care institution;

requirements of the legislation concerning storage of information on the patient;

the established regulations concerning the areas and arrangement of rooms of institution of health care according to DBN B.2.2-10-2001 "Buildings and constructions. Health care institutions";

sanitary standards and rules of rather cold and hot water supply;

requirements of the legislation for labor protection;

procedure for issue of leaves of disability according to the Instruction about procedure for issue of the documents certifying temporary disability of citizens, Ukraine approved by the order MZ of November 13, 2001 No. 455, of Ukraine registered in the Ministry of Justice on December 04, 2001 for No. 1005/6196;

c) provide:

advanced training of health and pharmaceutical workers;

informing medical personnel concerning observance of medical secret;

workers necessary washing and disinfectants, observance of requirements concerning their storage;

health and pharmaceutical workers sanitary clothes and individual protection equipment according to requirements of the legislation;

conditions for sink and disinfecting of hands;

respect for sanitary standards and rules concerning export and destruction of household garbage and medical waste;

approval and implementation of employment policies and procedures taking into account specifics of work of health and pharmaceutical workers;

availability, availability and completeness of first-aid kits for provision of emergency medical service;

d) designate person who meets single qualification requirements to position of the head of institution of health care;

ґ) to be provided with workers who are necessary for conducting economic activity on medical practice on medical, provisional professions and professions of junior specialists with medical and pharmaceutical education;

e) provide information concerning the patient according to requirements of the legislation;

e) receive the voluntary consent of the patient to performing diagnostics, treatment and to carrying out transaction and anesthesia;

є) to conduct accounting and reporting statistical forms in the field of health care according to the declared specialties;

g) hold anti-epidemic events for prevention of intrahospital infections;

h) designate the responsible person concerning providing with medicines;

i) store in the place of conducting activities:

normative legal documents, including regulating documents concerning standardization, necessary for maintaining the corresponding type of economic activity;

accounting and reporting statistical forms according to the declared specialties;

the accreditation certificate of institution of health care (on condition of functioning of institution of health care more than two years);

the certificate on certification of laboratory of institution of health care (in the presence of it in structure of institution of health care);

copies of documents in which educational and qualification levels of health and pharmaceutical workers are specified;

the conclusion of the state sanitary and epidemiologic examination about compliance of the available rooms to requirements of sanitary standards and rules concerning implementation of medical practice;

decision on creation of institution of health care;

the statement from the Unified state register;

licenses for maintaining types of economic activity which provide implementation of activities of institution according to profile and tasks which are stipulated by the legislation;

copies of certificates on state registration of medical equipment and products of medical appointment;

the documents provided by the subitem "an" of this Item.

2.8. On building facade where the institution of health care or its isolated structural division is placed, there shall be sign with indication of type of institution of health care, the name of the legal entity, the location and code on EGRPOU.

The name of the legal entity shall contain the name of only one of types of institutions of health care according to the List of institutions of health care approved by the order MZ of Ukraine of October 28, 2002 No. 385, registered in the Ministry of Justice of Ukraine on November 12, 2002 for No. 892/7180 (further - the List of institutions of health care).

Use by legal entities in the name and the name of structural divisions of types of institutions of health care and their phrases who do not answer the List of institutions of health care is not allowed.

2.9. The physical person - the entrepreneur shall:

a) approve:

nomenclature of cases on medical and pharmaceutical documentation;

rules and instructions of accomplishment of manipulations and procedures;

the instruction concerning rules of sink and disinfecting of hands;

the list and cost of services which according to the legislation are provided to patients;

b) adhere:

regulatory legal acts concerning stay of patients;

the established regulations concerning the areas and arrangement of rooms of institution according to DBN B.2.2-10-2001 "Buildings and constructions. Health care institutions";

requirements of the legislation for labor protection;

c) provide:

checking of means of the measuring equipment which are used in medical practice and are subject to metrological checking;

conditions for sink and disinfecting of hands;

respect for sanitary standards and rules concerning export and destruction of household garbage and medical waste;

d) keep medical secret;

ґ) to store and provide information on the patient in the procedure established by the legislation;

e) receive the voluntary consent of the patient to performing diagnostics, treatment and to carrying out transaction and anesthesia;

e) conduct accounting and reporting statistical forms in the field of health care according to the declared specialties;

є) to hold anti-epidemic events;

g) store in the place of conducting activities:

the statement from the Unified state register;

information on operations procedure in case of immediate conditions;

normative legal documents, including regulating documents concerning standardization, necessary for maintaining the corresponding type of economic activity;

accounting and reporting statistical forms according to the declared specialties;

conclusion of the state sanitary and epidemiologic examination about compliance of the available rooms to requirements of sanitary standards and rules concerning implementation of medical practice;

copies of documents in which educational and qualification levels of health and pharmaceutical workers are specified (in case of their hiring);

the documents provided by the subitem "an" of this Item.

2.10. The physical person - the entrepreneur has the right of employment of doctors (pharmacists) in the presence at the physical person - the entrepreneur of the highest qualification category on the declared specialty.

Employment of doctors (pharmacists) is performed in the specialty the physical person - the entrepreneur, and junior specialists with medical and pharmaceutical education - different profile.

Employment of doctors (pharmacists) and junior specialists with medical (pharmaceutical) education is performed provided that their qualification level meets the established requirements.

2.11. On facade of the building in which the physical person - the entrepreneur conducts medical practice there shall be sign with indication of medical specialties on which medical practice, surnames, name, middle name of physical litsapredprinimatel is conducted.

III. Qualification requirements to physical persons - entrepreneurs who conduct medical practice, and health (pharmaceutical) workers of institutions of health care

3.1. Persons who have the corresponding vocational education can be engaged in medical activities and meet single qualification requirements. Such requirements are established by the Reference book of qualification characteristics of professions of workers. Release 78th "Health care", the approved order MZ of Ukraine of March 29, 2002 No. 117.

The nomenclature of specialties is approved by the order MZ of Ukraine of December 19, 1997 No. 359 "About further enhancement of certification of doctors", the order MZ of Ukraine registered in the Ministry of Justice of Ukraine on January 14, 1998 for No. 14/2454, of November 23, 2007 No. 742 "About certification of junior specialists with medical education", registered in the Ministry of Justice of Ukraine on December 12, 2007 for No. 1368/14635, and the order MZ of Ukraine of December 12, 2006 No. 818 "About enhancement of certification of pharmacists and druggists", registered in the Ministry of Justice of Ukraine on December 26, 2006 for No. 1366/13240.

Compliance to special education and qualification requirements makes sure:

1) the diploma about the higher medical education of the state sample;

2) the certificate of the specialist doctor of the established sample issued by the highest medical educational institutions, institutions of post-qualifying education of the III-IV levels of accreditation according to the Regulations on procedure for carrying out certification of doctors approved by the order MZ of Ukraine of December 19, 1997 No. 359, registered in the Ministry of Justice of Ukraine on January 14, 1998 for No. 14/2454;

the certificate of the specialist pharmacist of the established sample issued by the highest pharmaceutical educational institutions, institutions of post-qualifying education of the III-IV levels of accreditation according to the Regulations on procedure for carrying out certification of pharmacists approved by the order MZ of Ukraine of December 12, 2006 No. 818, registered in the Ministry of Justice of Ukraine on December 26, 2006 for No. 1366/13240;

3) the certificate of assignment (confirmation) of the corresponding qualification category on medical specialties of the established sample given in appendix 4 to the Regulations on procedure for carrying out certification of doctors approved by the order MZ of Ukraine of December 19, 1997 No. 359, registered in the Ministry of Justice of Ukraine on January 14, 1998 for No. 14/2454;

the certificate of assignment (confirmation) of the corresponding qualification category on provisional specialty of the established sample given in appendix 4 to the Regulations on procedure for carrying out certification of pharmacists approved by the order MZ of Ukraine of December 12, 2006 No. 818, registered in the Ministry of Justice of Ukraine on December 26, 2006 for No. 1366/13240;

4) the certificate of assignment (confirmation) of the corresponding qualification category on professions of junior specialists with medical education of the established sample given in appendix 3 to the Regulations on certification of junior specialists with medical education approved by the order MZ of Ukraine of November 23, 2007 No. 742, registered in the Ministry of Justice of Ukraine on December 12, 2007 for No. 1368/14635;

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