A new order by the Romanian Ministry of Health, (“Order”) defines “mobile medical offices” and “mobile medical unit” and establishes the conditions for their establishment, organization and functioning.
Under the provisions of the Order, a mobile medical office is defined as a mobile medical structure organized on a specially designed vehicle (bus, caravan, trailer, van, chassis truck, truck, truck with semi-trailer, container, ship, boat, mobile pontoon) that travels to an area together with the medical staff for the provision of medical services, especially in rural areas or in areas with poor medical coverage. Services may be provided to adults and children and persons belonging to disadvantaged categories, as well as other persons.
The same order defines a mobile medical unit as the mobile medical structure composed of two or more mobile medical rooms with limited facilities organized on a specially arranged vehicle (bus, caravan, trailer, van, truck, chassis, tractor with a semi-trailer, a container, a ship, a sailplane, a mobile pontoon). The unit travels to areas together with its medical staff to provide medical services, especially in rural areas or in areas with poor medical coverage, to both adults, children, and persons belonging to disadvantaged categories, as well as to other people.
A mobile medical office and a mobile medical unit can be established by public or private sanitary units, public health institutions, non-profit organizations, foundations, associations with medical activities, professional associations, and legally constituted religious groups that comply with legal provisions governing these activities.
To perform medical services for patients, a mobile medical office or a mobile medical unit must obtain the necessary authorization before providing any services. A mobile medical office or a mobile medical unit must register with the registrar of medical offices kept by the local health public authorities based on the notice issued by the local Physician’s College.
The mobile medical office must have a minimum space of seven square meters, and the mobile medical unit, with at least two medical cabinets, must have a minimum space of 13 square meters. Mobile medical offices and mobile medical units should be equipped with devices (access ramp, elevator, platform lift) for disabled persons as required by law. The services must be provided in areas not subject to flooding and accessible to the population.
The office or mobile medical unit must have the following minimum composition:
- treatment room – minimum six sqm;
- storage space – 1 sqm;
- a compartment for sampling, as appropriate;
- instruments for the sterilization of instrumentation, as appropriate;
- sink provided with running water;
- to ensure a cold chain, as appropriate, the mobile medical cabinet will be equipped with an isothermal bag with a thermometer for the transport of the vaccines and at least one refrigerator equipped with a thermometer for the transport of the biological samples if biological fluid sampling occurs and samples are not transported by authorized units for this purpose.
The vehicle must meet the following requirements:
- at least two entrances-exits must be provided in the mobile medical unit with at least two medical cabinets: one at the rear to ensure vertical access of up to 1,900 mm vertically from the ground and one at the side (sliding door with glass 2/3 mat). In the mobile medical cabinet with authorized minimum space, a single sliding side access door is sufficient;
- all openings must have seals against water infiltration;
- the existence of a current source that makes it possible to charge the battery and other equipment, the medical equipment, and the heating and cooling of the sampling compartment. The operator may not start the engine while it is connected to an external power supply of 220 V;
- all materials used inside the vehicle must have flame retardant properties, with a combustion rate of not more than 100 mm/minute;
- floors, walls, ceilings, and work areas in medical premises must be: washable, disinfected, resistant to radioactive decontamination, and acid-resistant. In treatment rooms, non-regenerative fibers or particles may remain suspended in the air, with no dust-sensitive dirt;
- carpeting is forbidden. The floor must include parquet or epoxy resins. No false ceilings made of microporous material and with roughness are allowed;
- if the floor does not allow the fluids to drain, there must be one or more drains provided with plugs and edges of the flooring must be rounded up to the wall;
- open shelves should be constructed with rounded edges, and drawers must be secured against accidental opening;
- the existence of a ventilation system which must provide a minimum of 20 hourly replacements of the inside air volume when the vehicle is stationary; the configuration of the system will prevent exhaust gases from entering the sample collection compartment;
- include an adjustable, independent air heating system;
- include a complete electronic air cooling system that will serve the sampling compartment;
- for radiological devices, special permits are required to allow location and operation of such devices. Permission must be obtained from the authorities responsible for controlling activities using nuclear radiation. In these medical offices, the rules of radiation protection and individual exposure control must be followed.
Offices or mobile medical units authorized before the effective date of these new rules are required to comply with them within six months after they become effective.
The Order was published in the Official Gazette no. 432 dated May 22, 2018, under no. 606/2018 and became effective upon publication.