Act of the Czech National Council No. 160 / 1992 Coll.
Act of the Czech National Council on Health Care in Non-State Medical Devices
Valid
Effective from 15.04.1992
160
THE LAW
Czech National Council
of 19 March 1992
on health care in non-state health establishments
The Czech National Council decided on this law:
BASIC PROVISIONS
Subject matter
This law regulates the conditions and scope of the provision of health care in non-state health institutions ("non-state facilities') and the conditions for the operation of non-state facilities.
Non-state installations
(1) Non-state facilities means health facilities other than state health facilities (1)
(2) A natural or legal person authorised under this Act (hereinafter referred to as "operator ') may operate a non-state establishment.
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Scope of healthcare provided
(1) Medical care may be provided in non-state establishments by counselling, nursing, diagnostic, preventive, rehabilitation, spa, treatment and pharmacy. In non-state facilities, outpatient and constitutional care can be provided, including provision of medical equipment and transport services for the transport of patients.
(2) In non-state establishments, healthcare reserved under the State's special rules cannot be provided. (2)
Conditions for providing health care
(1) Non-state facilities must be staffed, factually and technically equipped for the type and extent of healthcare provided by them and comply with the requirements laid down for its operation.
(2) The Ministry of Health of the Czech Republic provides for regulations
(a) hygiene requirements for the operation of medical devices;
(b) technical and material requirements for medical equipment.
Obligations of non-state establishments
(1) Save as otherwise provided for in this Act, health care provision in non-state establishments, including the obligations of such establishments, health care laws (3) and provisions issued for their implementation.
(2) In addition, the non-state establishment shall:
(a) to provide healthcare only of the kind and to the extent that the provision of healthcare is provided for in the marketing authorisation;
(b) cooperate with other health establishments where this is necessary in the provision of healthcare;
(c) inform in advance what kind of healthcare it provides, to what extent and under what conditions;
(d) maintain operational and health documentation and carry out tasks for the general and health information system, 4)
(e) conclude a contract with the county responsible for issuing the authorisation decision if it so requests, for the purpose of ensuring health care within its area of competence, and on the basis of it, take part in the provision of the necessary health services, in particular emergency services, including emergency services, first aid medical services, health care in mass accidents, poisoning and natural disasters, enacted investigations, inspections and measures in relation to anti-epidemic measures, inspections and assessments of the medical capacity of persons (e.g. in emergency procedures, at the request of state authorities, etc.).
Professional competence
Health care in non-state establishments shall be authorised to be provided to the extent and in a manner appropriate to their professional competence by healthcare professionals competent to pursue the profession under specific legislations6).
Method of payment of health care
(1) Health care in non-state establishments is provided:
(a) without direct payment from the person who has received health care
1. based on general health insurance or contractual health insurance, 7)
2. where the costs of healthcare provided are reimbursed by another medical institution or by another legal or natural person on the basis of a contractual relationship concluded with a non-State operator;
3. if the operator of a non-state installation withdraws from it; or
(b) for direct payment from the person to whom medical care has been provided; or
(c) a combination of the method of payment referred to in (a) and (b).
(2) Health care prices for direct remuneration are negotiated in accordance with special rules. 8)
IMPLEMENTATION OF NON-STATE INSTALLATIONS
Operating authorisation
(1) The authorisation to operate a non-state installation is established by a decision to register the regional authority responsible for the location of the non-state installation.
(2) The authorisation to operate a non-state establishment operated by a natural person or legal person other than the municipality or capital of Prague in the capital of Prague is established by a registration decision of the district office. The right to operate a non-state facility, the operator of which is the urban part of the capital of Prague, is established by a decision to register with the Municipality of Prague. The right to operate a non-state facility operated by the capital city of Prague is established by the decision to register the Ministry of Health of the Czech Republic.
General terms and conditions of registration
(1) Where the operator of a non-state establishment is a natural person, it shall be fully competent to act, be fair and have competence and medical fitness (6) corresponding to the type and extent of healthcare provided by the non-state establishment.
(2) Where the operator of a non-State establishment is a legal person or a natural person who does not have the competence of the appropriate type and extent of health care provided by a non-State establishment, he shall be required to appoint an expert representative who shall comply with the conditions referred to in paragraph 1. The professional representative shall be in an employment relationship or similar employment relationship with the operator of a non-state establishment, unless he is a member of a trading company that is an operator, and shall be responsible for the professional management of the non-state establishment.
(3) For the purposes of this law, those who have not been convicted of an intentional crime or have not been convicted of a criminal offence committed as a result of negligence in connection with the provision of health care shall be deemed to be righteous.
Application for registration
(1) The Regional Authority, the City of Prague or the Ministry of Health of the Czech Republic (hereinafter referred to as the "authority responsible for registration") shall register at the request of the operator of the non-state installation.
(2) The application shall contain:
(a) the name, surname, permanent residence and birth number if the operator of the non-state establishment is a natural person; where the operator of a non-state establishment is a legal person, name, registered office, legal form, name, surname, permanent residence and family number of the person or persons who are the statutory authority and name, surname, permanent residence and professional representative's home number,
(b) the type and extent of healthcare provision;
(c) the place of operation of the non-state installation, including the indication of ownership or rental relationship;
(d) the date of commencement of the operation of the non-state installation.
(3) The non-state operator shall attach the following documents to the registration application:
(a) evidence of education, evidence of medical fitness,
(b) the agreement of the authority responsible for registration with personnel and material equipment, the type and extent of health care provided by non-state establishments when operating a pharmacy, issues certificates of material and technical equipment of the State Institute for Drug Control;
(c) the approval of the Ministry of Health of the establishment of a haematopoietic cell donor centre and an organ collection and transplantation centre (9a);
(d) the consent of the Ministry of Health to carry out the procedures and methods of assisted reproduction, if applicable on the implementation of the methods and procedures of assisted reproduction;
(e) Certificate for the performance of a medical profession without professional supervision issued by the Ministry of Health of the Czech Republic under special legislation, 9b)
(f) operating rules approved by the competent public health authority, 10)
(g) the consent of the State Institute for Drug Control to material and technical equipment, if applicable, for the operation of the dispensary of medical devices, 9c)
h) consent of the Czech Inspectorate of Spa and Foundation, if it is to operate a non-state spa facility, 12)
(i) the consent of the Ministry of Health of the Czech Republic, if it is a foreign legal or natural person, with the exception of nationals of Member States of the European Union or legal persons fulfilling the conditions of Article 48 of the Treaty establishing the European Community,
(j) a contract with a state health establishment or non-state establishment, the effectiveness of which is subject to a decision on registration, where the provision of healthcare is subject to a lease contract. The lease or sublease contract shall not restrict the lessee or sublessee in the free pursuit of the profession.
(4) Where the operator is a legal person or a natural person referred to in Article 9 (2), the documents referred to in paragraph 3 (a) or (b) and (c) and (i) shall concern its expert representative.
(5) Where the application does not contain the particulars referred to in paragraph 2 or is not accompanied by any of the documents required under paragraph 3, the competent authority responsible for the registration shall return it to the applicant for replenishment. If it is not completed, it shall reject the application for registration.
(6) In order to demonstrate the integrity of the operator of a non-state health facility, the competent authority responsible for registration shall, in accordance with the special legislation 9d, request an extract from the Register of Penalties. An application for an extract from the Register of Penalties and an extract from the Register of Penalties shall be sent in electronic form in a way that allows remote access.
Marketing Authorisation
(1) The marketing authorisation shall contain the particulars referred to in Paragraph 10 (2) and the identification number of the person provided by the administrator of the basic register of persons 12a).
(2) The competent authority responsible for registration shall send a copy of the marketing authorisation to the competent authority in charge of the administration of the tax, the State Statistics Authority, the relevant state professional organisation established by law (hereinafter referred to as the Chamber) 10 and which has issued the certificate referred to in Article 10 (3) (d). Where the operator of a non-state establishment is a natural person, the competent authority for registration shall also send a copy of the marketing authorisation to the authority carrying out its social security.
Amendments and cancellation of registration
(1) The operator of the non-state facility shall notify the competent authority of the registration within 15 days of any changes to the information contained in the marketing authorisation and the documents it is obliged to attach to the registration application.
(2) Where changes are made to the information contained in the marketing authorisation or to the documents required by the NSAs to be attached to the application for registration, the competent authority shall decide on the change or, where appropriate, the revocation of the marketing authorisation. Where changes to the information referred to in Article 10 (3) (a), (b), (c), (d), (e), (f), (g) and (h) are concerned, the Chamber or the authorities concerned shall request comments before taking a decision.
(1) The competent authority responsible for registration shall withdraw registration if:
(a) the operator of a non-state establishment has lost the certificate or consent or fitness to pursue the medical profession under specific legislation6) or the authorisation; the registration shall be revoked even in the event of a serious or repeated breach of the hygiene and anti-epidemic principles for the operation of health facilities established by the public health authority;
(b) the operator of the non-state installation has so requested.
(2) A non-state installation operator shall be obliged to submit a request for revocation three months before the date on which it requests the withdrawal of the registration.
(3) The authority responsible for registration may cancel registration if the operator is in breach of the conditions or obligations arising from the marketing authorisation, from this Act, from the People's Health Care Act, (3) the General Health Insurance Company of the Czech Republic, (12b) or, contrary to generally binding legislation, requires financial compensation for health care or for the admission of the patient.
(4) The competent authority responsible for registration shall send a copy of the decision to amend or revoke the registration to the authorities referred to in Article 11 (2), as well as to the health insurance undertaking with which the medical establishment is under contract.
(5) A separate regulation shall also apply to the revocation of the registration of non-State establishments referred to in paragraph 1 (b). 13)
COMMON, TRANSITIONAL AND FINAL PROVISIONS
Fines
(1) The authority responsible for registration may impose a fine on the operator for the breach of the obligation under this Act, except for the obligation under Paragraph 13 (2) of the People's Health Care Act, (3) by the Act on the General Health Insurance Company of the Czech Republic 12b), and in the event that the operator requests, contrary to generally binding legislation, financial compensation for health care or for the admission of the patient.
(2) The fine may be imposed within three months of the date on which the authority responsible for registration became aware of the infringement which entitles the imposition of the fine, but not later than one year from the date on which the non-State-owned establishment operator infringed it.
(3) The management of the fines is carried out by the competent authority responsible for the registration which imposed the fine. The fines shall constitute the revenue of the budget of the authority responsible for registration.
Insurance against damage
Where a non-state operator employs at least one worker, he shall be obliged to enter into contractual liability insurance for damage to his staff in the performance of his duties or in direct connection with them for which the operator is responsible. An operator of a non-state establishment shall be obliged to enter into contractual insurance in such a way that the insurance contract is effective on the date of the employment.
The operator of a non-state establishment is obliged to conclude a contract with an insurance undertaking operating in the Czech Republic on liability insurance for damage caused to citizens in connection with the provision of health care. This insurance must last as long as the non-state operator provides health care.
Training of care provided
(1) The competent Comoros shall ensure the expertise of healthcare provided. 14)
(2) In other cases, the competent authority responsible for registration shall ensure the expertise of the care provided by the non-state establishment. In doing so he works with the Ministry of Health of the Czech Republic, with professional organisations and professional civil associations. 15)
Decision-making
Decisions under this Act are subject to general administrative rules. These provisions shall also apply to decisions under § 10 (3) (b), (f), (g) and (h).
The labour relations between the operator of a non-state installation and its personnel shall be governed by specific rules. 16)
Until 31 December 1993, the competent authority responsible for registration shall send a copy of the decision pursuant to Article 11 (2) to the General Health Insurance Company of the Czech Republic.
Medical facilities established or managed by municipalities at the date of application of this Act, 17) shall be considered non-state establishments within the meaning of this Act. These non-state establishments must comply with the conditions laid down in this Act by 31 December 1992 at the latest.
The scope laid down by the Regional Authority under this Act is the exercise of the delegation.
Operators of non-state health establishments that are natural persons and charged on 31 December 2003 in a system of simple accounting shall fulfil their legal obligation laid down in § 5 (2) (e) of Act No. 160 / 1992 Coll., as effective before the date of entry into force of Act No. 121 / 2004 Coll., provided that on 1 January 2004 they keep tax records or accounts in accordance with a special law.
The Act of the Czech National Council No. 220 / 1991 Coll., on the Czech Medical Chamber, the Czech Dental Chamber and the Czech Pharmacy Chamber are amended as follows:
1. in Paragraph 2 (2) (c), after the words "their members," the words "and for the performance of the duties of professional representatives in accordance with a special regulation and the leading doctors and primary practitioners in non-state health institutions" shall be added;
2. in Paragraph 2 (2) (d), the words "private practice of their members" shall be replaced by the words "under (c)."
Efficacy
This Law shall take effect on 15 April 1992.
Burešová v. r.
Pithart v. r.
1) Article 11 (1) of Act No. 20 / 1966 Coll., on the Care and Health of the People, as amended by Act No. 548 / 1991 Coll.
2) E.g. § 34, 71 and 75 of Act No. 20 / 1966 Coll., as amended by Act No. 425 / 1990 Coll. and Act No. 548 / 1991 Coll.
3) Act No. 20 / 1966 Coll., as amended by Act No. 210 / 1990 Coll., Act No. 425 / 1990 Coll., Act No. 548 / 1991 Coll. and Act No. 550 / 1991 Coll.
4) Article 22 of Act No. 21 / 1971 Coll., on the Single System of Socio-economic Information, as amended by Act No. 128 / 1989 Coll.
5 (a) § 16 of the Decree of the Government of the Czech Republic No. 216 / 1992 Coll., which publishes the Health Regulations and implements certain provisions of the Act of the Czech National Council No. 550 / 1991 Coll., on General Health Insurance, as amended by the Decree of the Government of the Czech Republic No. 50 / 1993 Coll.
6) Act No. 95 / 2004 Coll., on the conditions for obtaining and recognising professional competence and specialised competence for the pursuit of the medical profession of doctor, dentist and pharmacist. Act No. 96 / 2004 Coll., on the conditions for obtaining and recognising competence for the exercise of non-medical medical professions and for the pursuit of activities related to the provision of healthcare and on the modification of certain related laws (Law on non-medical medical professions).
7) Act No. 550 / 1991 Coll., on General Health Insurance.
8) Act No. 526 / 1990 Coll., on Prices.
9a) § 70 (2) of Act No. 20 / 1966 Coll., as amended. Act No. 285 / 2002 Coll., on donation, collection and transplantation of tissues and organs and on the modification of certain laws (transplant law).
9b) Act No. 96 / 2004 Coll.
9c) Decree No. 49 / 1993 Coll., on technical and material requirements for medical equipment, as amended.
9d) Act No. 269 / 1994 Coll., on the Register of Penalties, as amended.
10) Paragraph 15 (2) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws.
12) Decree of the Ministry of Health of the Czech Republic No. 26 / 1972 Coll., on the protection and development of natural medical baths and natural medical resources.
12a) Act No. 111 / 2009 Coll., on Basic Registers.
12b) § 26 of Act ČNR No. 551 / 1991 Coll., on General Health Insurance Company of the Czech Republic.
13) Article II of Act No. 548 / 1991 Coll., amending and supplementing Act No. 20 / 1966 Coll.
14) § 2 (1) (a) of ČNR Act No. 220 / 1991 Coll.
15) § 10a of Act No. 20 / 1966 Coll., as amended by Act No. 548 / 1991 Coll. Act No. 83 / 1990 Coll., on bringing together citizens, as amended by Act No. 300 / 1990 Coll. and Act No. 513 / 1991 Coll.
16) Act No. 65 / 1965 Coll., Labour Code, as amended, and the regulations implementing it.
17) Paragraph 14 (2) (b) of the ČNR Act No. 367 / 1990 Coll., on municipalities (municipal establishment). Section 10 of the ČNR Act No. 418 / 1990 Coll., on the Capital City of Prague. § 5 paragraph 1 (b) of the ČNR Act No. 172 / 1991 Coll., on the transition of certain items from the property of the Czech Republic to the ownership of municipalities.
1) Directive No 10 / 1986 of the Ministry of Health of the Czech Republic. MZ ČSR on the activity of middle, lower and auxiliary health workers (reg. in amount 21 / 1986 Coll.).
2) If a nurse is to perform the specialisation work referred to in § 3, 4, 5, 6, 7, 8, 9 of the Directives, she must have completed the specialisation course in that field of activity.
3) If a child nurse is to carry out the specialisation work referred to in § 12, 13, 14, 15, 16, 17, 18 of the Directives, she must have completed her specialisation studies in that section of activity.
4) If a female nurse is to perform the specialisation work referred to in § 21, 22, 23, 24 of the Directives, she must have completed her specialisation course in that section of activity.
5) If the diet nurse is to carry out the specialisation work referred to in Section 27 of the Directives, she must have completed her specialisation course in that field of activity.
6) If a rehabilitation worker carries out the specialisation work referred to in Sections 30 and 31 of the Directives, he must have completed his specialisation studies in that section of the activity.
7) If a medical laboratory will carry out the specialisation work referred to in § 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 directives, it must have completed the specialisation studies in that section of activity.
8) If the radiological laboratory will perform the specialisation work referred to in Sections 57, 58, 59 of the Directives, it must have completed its specialisation course in that field of activity.
9) If a dental technician performs the specialisation work referred to in Sections 61, 62, 63 of the Directives, he must have completed his specialisation course in that field of activity.
10) For other pharmaceutical technicians, full secondary vocational education is a qualification requirement.
11) Lower health professionals can only provide healthcare under the guidance of a highly qualified worker who determines the extent of their independent activities.
12) Auxiliary health workers may provide health care only under the guidance of a worker with a higher professional qualification, which determines the extent of their independent activity.
13) Only a clinical psychologist can work alone in a non-state facility.
14) In a non-state facility, only clinical logoted can work separately.
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Regulation Information
| Citation | Act of the Czech National Council No. 160 / 1992 Coll., on Health Care in NSAs |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 01.04.1992 |
|---|---|
| Effective from | 15.04.1992 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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