Medical care

Section 30 of the Trade Regulation Act (GewO) only covers private hospitals that are operated on a commercial basis, i.e. with the intention of making a profit. Upon presentation of an exemption notice from the corporate tax office, the licensing procedure no longer applies, since a clinic is then not operated commercially but pursues non-profit purposes.

Likewise, Section 30 GewO does not cover day clinics, practice-based clinics or other facilities in which medical services are regularly provided on an outpatient basis.

• informal application (including details of the location and name of the planned clinic),

• designation of the clinic operator, legal form of the clinic, designation of the management,

• for companies or legal entities: articles of association and extract from the commercial register,

• information from the Central Trade Register (GZR 3; to be requested from the municipality of residence) for the operator, in the case of partnerships (e.g. general partnership (OHG), limited partnership (KG)) for the partnership itself and for the personally liable partners, in the case of legal entities (e.g. GmbH) for the entity itself and for the bodies authorised to represent it (e.g. managing directors), prior to the granting of the licence (must not be older than 3 months),

• certificate of good conduct for submission to an authority (document type OB; also to be requested from the municipality of residence) for the operator, in the case of companies for the personally liable partners, in the case of legal entities for the bodies authorised to represent it, prior to the granting of the licence (must not be older than 3 months),

• tax clearance certificate from the competent tax office, for companies/legal entities see no. 4, prior to the granting of the licence (must not be older than 3 months),

• submission of qualification certificates and professional licences of the persons employed at the clinic (officially certified photocopies of the certificates),

• extract from the land register or proof of the right of disposal (rental/lease agreement) over the property in which the facility is to be operated (in the case of renting subsidised rooms and their fittings in planned hospitals: permission from the Cologne district government pursuant to § 22 (1) of the Hospital Design Act of the State of North Rhine-Westphalia),

• official cadastral site plan,

• proof of the application for the building measure or application for a change of use in accordance with the guideline on building supervision requirements for the construction and operation of facilities providing nursing and care services, submitted to the competent building supervision authority (final acceptance certificate from the building supervision authority and the fire brigade is required prior to licensing),

• construction drawings (floor plans and sections) indicating the room size and intended use of the rooms (including patient beds per room) as well as the layout of routes,

• proof of the conclusion of liability insurance for the clinic,

• description of operations/concept of the clinic (detailed)

  • list of the clinic's discipline(s) with a detailed presentation of the respective diagnostic and/or treatment spectrum (clinical conditions),

  • description of the equipment and organisational measures in place to manage complications or emergencies (emergency kit, ventilator, defibrillator, emergency laboratory),

  • designation of the medical director and deputy,

  • designation of the nursing service management,

  • description of the staffing concept for all functional areas of the clinic with the corresponding professional qualifications (including number of posts),

  • information on ensuring a 24-hour medical service, including Sundays and public holidays,

  • proof of ensuring emergency power supply,

  • contractual agreement on the supply of medicines (note approval of the responsible official pharmacist),

  • contractual agreement on the provision of meals,

  • contractual agreement on the supply and disposal of laundry,

  • contractual agreement on the disposal of waste,

  • contractual agreement on laboratory services,

  • contractual agreement with a funeral director,

• proof of certified cleaning,

• proof of qualification for the reprocessing of medical devices,

• proof of occupational health care for all persons employed at the clinic,

• proof of the contractual engagement of an occupational safety specialist,

• cooperation agreement with a hospital for the further care of patients as part of emergency treatment, insofar as this cannot be provided at the clinic,

• emergency plan and cooperation agreement with a hospital in the event of a damage incident with/without evacuation,

• detailed expert opinion from a hospital hygiene specialist relating to the circumstances presented in the concept (in accordance with the Hygiene and Medical Devices Ordinance, HygMedVO),

• hygiene plan and cleaning and disinfection plans. Pursuant to § 36 of the Infection Protection Act (IfSG), a hygiene plan must set out internal procedures for infection hygiene. The hygiene plan should contain written provisions for all hygiene-relevant processes of the private clinic, including measures relating to disinfection, cleaning, sterilisation, and supply and disposal.

• concept for the ongoing recording and evaluation of the occurrence of hospital pathogens with special resistances and multidrug resistances (to be agreed with a hospital hygiene specialist and evidenced) (§ 23 (4) IfSG). Among other things, this does not apply to rehabilitation and psychiatric facilities.

• proof of the appointment of a hygiene commission,

• consulting agreement with a hospital hygiene specialist),

• proof of the appointment of a hygiene officer physician (proof of qualification),

• contractual agreement on the employment of one or more hygiene specialists (with proof of qualification; number of hours calculated in accordance with KRINKO [Commission for Hospital Hygiene and Infection Prevention]),

• proof that the drinking water installation complies with the generally recognised rules of technology,

• proof of the safety of the operation of ventilation and air-conditioning systems (including recooling units), including a statement from the hospital hygiene specialist (necessary examinations to be carried out only shortly before the planned commencement of operations).

The fee range for granting a concession is between €250 and €7,500.