Chapter III: Conditions for setting up certain healthcare activities and heavy equipment

The interventional radiology activity referred to in 21° of article R. 6122-25 includes all medical procedures for diagnostic or therapeutic purposes performed with medical imaging guidance and control by percutaneous, transorificial, transparietal or intraluminal access, involving one or more targets that are inaccessible under satisfactory quality and safety conditions without the use of an imaging guidance device, with the exception of procedures relating to the activities referred to in 11°…

Authorisation for interventional radiology activities may be issued for the following categories : 1° Category A including, with the exception of procedures specifically covered by categories B, C and D, endovenous interventional radiology procedures, including those for the installation of approach routes, as well as the following percutaneous and transorificial procedures: deep infiltrations, punctures, biopsies and drainages of intra-thoracic, intra-abdominal or intra-pelvic organs; 2° Category B including, in addition to…

I. – The holder of the authorisation for category A has access to a continuous monitoring unit on site or by agreement, under conditions that allow the patient to be cared for within a timeframe that is compatible with the imperatives of safe care. II. – The holder of the authorisation for category B has : 1° On site, a continuous monitoring unit ; 2° On-site or by agreement, in…

The authorisation holder guarantees that the medical biology tests required for the activity will be carried out within a timeframe compatible with the quality of patient care.

The provisions of sub-section 2 of section 7 of this chapter relating to cancer treatment activities are applicable to the holder of the authorisation under grades C and D when it carries out interventional radiology activities with the aim of curing the tumour, with the exception of the provisions of 2° of article R. 6123-91-1, those of I and III of article R. 6123-91-3, as well as the provisions of…

The holder of the authorisation for category A has a scanner and an ultrasound scanner on site. The holder of the authorisation for categories B and C has access to : 1° On-site access to a scanner and an ultrasound scanner ; 2° On-site or by agreement to a nuclear magnetic resonance imaging machine. The holder of the authorisation for category D has access, on site, twenty-four hours a day,…

The authorisation holder must ensure continuity of post-intervention care. For holders of authorisations issued under categories A, B and C, continuity may be ensured by agreement with another holder of an interventional radiology authorisation. In this case, where continuity is organised across several authorised sites, the agreement specifies in particular the organisational arrangements between the sites, the involvement of staff from each site and the arrangements for patient referral and…

The holder of the authorisation for category D ensures, on a permanent basis, in conjunction with the emergency medical assistance service mentioned in article R. 6123-1, the diagnosis and treatment of patients likely to benefit from this activity. This round-the-clock service may be shared by several authorised sites, in accordance with the procedures for organising access to care defined in the regional health plan. In this case, an agreement is…