Applying for a licence for a private clinic

Description

Operators of private hospitals (private clinics) that are run commercially, i.e. with the intention of making a profit, generally require a licence in accordance with Section 30 of the German Trade Regulation Act (GewO).

A hospital is eligible for a licence if the facility in question meets the minimum requirements in terms of personnel, equipment, space and organisation based on its concept and medical orientation and none of the grounds for refusal listed in the law apply.

Required documents

Letter of application

Clinic concept

Naming of the operators

• Business registration
• curriculum vitae in keywords
• Certificate of good conduct (document type "O")
• Self-disclosure regarding previous convictions - pending criminal proceedings
• Fine proceedings for offences in connection with a commercial activity
• pending trade prohibition proceedings
• Information from the local court on entries in the insolvency register
• Information from the central trade register for submission to authorities (to be requested from the municipality of residence) for the legal entity and for all legal representatives

for GmbH / other legal entities

• Shareholders' agreement, articles of association, list of shareholders,
• Latest extract from the commercial register/register of co-operatives,
• Business registration
• Information from the local court on entries in the insolvency register for the legal entity and for all legal representatives
• Information from the local court about entries in the debtor register
• Tax clearance certificate

additionally from the managing directors/legal representatives:

• Self-disclosure regarding previous convictions - pending criminal proceedings,
• Fine proceedings for offences in connection with a commercial activity,
• pending trade prohibition proceedings,
• Information from the local court on entries in the insolvency register,
• Information from the central trade register for submission to authorities (to be requested from the municipality of residence) for the legal entity and for all legal representatives

Appointment of the medical management and department heads including their deputies,

Medical management or their deputy:
presentation of

• the licence to practise medicine,
• doctorate, if applicable,
• specialist doctor's certificates incl. specialisation competence and other further training certificates;
• Certificate of good conduct (document type "O")
• Confirmation from the Medical Association that no professional ethics court proceedings have been initiated and that no professional court convictions have been pronounced.

Head of department and their deputy:

• Confirmation from the Medical Association that no professional tribunal proceedings have been initiated and no professional convictions have been pronounced.

Spatial/structural representation of the clinic property

• Land registry site plan of the building with cardinal points
• Building, room and functional plans in duplicate, scale 1:100 (please no electronic feeds!) with statements from a hospital hygienist, the trade supervisory office and the fire department)

with corresponding dimensions, number, size, equipment, purpose

Illustration:

• Patient rooms
• Information on the number of beds per room
• Support points/nurses' rooms
• Social rooms in accordance with ArbStättV
• Staff changing rooms
• WC (staff/visitors)
• Examination rooms
• Functional departments
• non-bedside areas (operating theatre, radiology, laboratory area, physical medicine, CSSD, kitchen, laundry, clean/unclean work areas, storage)
• Mortuary
• Occupancy overview (bed plan) separated according to building sections or floors.
• Copy of the building permit (text section only); in the case of an existing clinic, the modification building permit is required;
• In the case of partial occupancy of a building: representation of which parts of the building or persons not belonging to the institution live in.

Bed preparation (description of centralised or decentralised bed preparation)

• Technical equipment
• Backup power supply
• Emergency call system (acoustic, optical)
• Basic equipment for the treatment of medical emergencies, for resuscitation (emergency kit, so-called "Ulm kit", defibrillator)
• medical-technical equipment appropriate to the focus of treatment
• Air conditioning/room ventilation technology
• Lifts (bed transport)

Hygiene management

Submission of a hygiene concept developed by a hospital hygienist and adapted to the hospital organisation and hospital structures, including an adapted and complete hygiene plan, cleaning and disinfection plans, proof of validated medical device reprocessing

Urgent recommendation:
Involve a hospital hygienist as early as the planning phase to avoid planning/construction defects.

The above list is not exhaustive; depending on the specific design of the licence object, it may be necessary to submit further documents.

Legal basis

§ 30 Trade Regulations