Legislation regarding medical and dental care units functioning.
(Extract from Romanian law no. 575 of 22/08/2007)
Art. 1. – The medical and dental units, created and organized under the law, need a sanitary authorization.
Art. 2. – The sanitary authorization of the medical care is released by the authorities of public health departments, or by the ones in Bucharest, according to the case, upon the declaration of the legal representative of the medical unit, referring to ensure the legal standards of the functional structure, the hygiene and public health norms. The authorization requires annual validation.
Art. 3. – In the case of medical practices founded by doctors and dentists, organized in groups of medical cabinets, associations, medical civil societies, commercial societies having unique activity object and having work places located in different areas there is to be issued a sanitary authorization for each work point (medical practice and dental practice).
Art. 4. – The sanitary authorization is issued upon the request of the legal representative of the medical service dentistry.
Art. 5. – The departmental state of public health inspection, or the Bucharest state sanitary inspection periodically verifies the hygienic and sanitary conditions and structures of functional spaces, according to the activity profile.
Art. 6. - (1) from the point of view of the structure of the spaces destined to be medical units and dental units and their functional circuits, the sanitary authorizations, issued on the basis of previous regulations for the dental units that are active in the respective spaces at the date of the issuing of the present document, are valid in case the current norms are respected.
(2) The spaces destined for the activities of the medical spaces and dental practices can go through structural, circuit and utilities access modifications, in the view of ensuring a better functional adaptation, provided the legal provisions regarding the safety in constructions are respected, and limited by the technical and engineering possibilities available in the given space. The departmental or municipal state public health authorities, counsel the legal representatives of the units regarding the functional circuits and advise upon the changes projects.
(3) The medical unit is to be formed of, at least, a waiting room, a toilet, a treatment room, check-up room and storage room.
a) The waiting room is to be set up so that each seating space benefits from a surface of at least 1-1,5 m2/person for adult care and 1,5-2 m2/person for children care (as the accompanying person is included).
b) The checkup room is to have a surface of at least 9 m2 and access to a sink connected to a running (hot and cold) water source.
c) The treatment room, is to have a surface of at least 9 m2, will be set up and provided with a sink connected to a running (hot and cold) water source.
(4) The dental practice will be formed of, at least, waiting room, toilet, storage rooms and the dental practice room, where the clinic diagnosis and treatment operations are to be performed; for the waiting room, the regulations stated under art. 6 alin. (3) lit. a). are to be applied.
a) The dental practice can be structured as follows:
- closed system – the dental unit is set up in a closed room;
- semi-open system – one or more units, separated by a wall or a cover are set up;
- open system – the units are set up in the same room, without any separation in between.
b) The dental practice, irrespective of the system it works in (closed, open, semi-open) will have a space of minimum 9 m2 allocated for each work unit.
c) the space for each dental unit will be provided with a sink connected to a water source.
(5) 1. Pavements, walls, ceilings and work surfaces where the medical activities are performed will be:
b) resistant to disinfectants;
c) resistant to radioactive decontaminations;
d) resistant to acids action (in treatment rooms);
e) without generating fibers or particles can remain suspended in air;
f) without asperities that keep dust.
2. It is forbidden to set up false ceilings with finely porous materials or with asperities.
3. It is forbidden to cover the floors with carpets.
(6) In case of medical practices with 3 or more doctors, who provide medical services in case of contagious diseases, given the space available, a space for vaccinations can be set up, separate from the treatment room.
(7) In the practices where surgical interventions are performed and hospital care is required, a room for post-op recovery will be set up, with at least 7 m2 surface available for each bed included.
(8) The medical staff in the medical and dental practices a locker room will be provided; the number of lockers will vary according to the number of staff members who work at the same time in that practice.
(9) The administrative rooms will be separate form the ones where the medical activities are performed.
(10) In order to respect the regulations, the medical and dental practice will have a toilet for patients, accessible from the waiting room, separate from the one destined to be used by the medical staff.
(11) The radiology medical units or dental units that use dental radiology machines have the liability to request and receive special authorizations to set up and use the machines, from the authorities responsible with the control of the activities that are to be performed using nuclear radiations. In this cabinets it is mandatory to respect the norms of radio protections and individual check of exposure to radiations.
Art. 10. – Mandatory hygienic and sanitary norms for medical practices and health centers:
a) potable water supplies;
b) connection to the drainage system of the city/village, so that the residual waters do not produce the pollution of the water, air and soil;
c) the waste resulted after the medical activities is to be collected, stored, evacuated and neutralized according to the current legal provisions;
d) ensuring a proper micro climate;
e) ensuring natural and artificial light necessary for the optimal performance of the medical activities;
f) reducing the noise under the admitted norms and/or ensuring an efficient anti noise protection inside and outside the practices;
g) materials for cleaning and disinfection of the medical units;
h) supplies of disinfectants, antiseptics and decontaminants authorized by the National Commission for Biocide Products. The use of these materials is to be performed according to the using specifications, in the concentrations and time of use specified by the producer;
i) protective equipment for all staff, in accordance with the law;
j) permanent instruction of the sanitary personnel regarding the universal precautions.
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