Paragraph 1: General provisions

I.-The interventional sector referred to in article R. 6123-201 is adapted to the practice of the surgical care activity concerned and anaesthesia, from the immediate preparation of the patient before the operation to the end of post-interventional monitoring, subject to the provisions of article D. 6124-98-1.

II.-The interventional sector is subject to controlled access and comprises:

1° A protected interventional block with several interventional rooms, each of which is protected;

2° Technical rooms, where appropriate, located in the protected interventional block.

The interventional sector and its protected interventional block must be physically delimited and signposted.

III.-The following services must be provided in the interventional sector with controlled access:

1° The medical preparation of patients for the surgical procedures defined in article R. 6123-201 and, where applicable, for interventional procedures;

2° The preparation of staff to perform the procedures mentioned in 1°;

3° The performance of surgical procedures;

4° Continuous post-interventional monitoring as mentioned in article D. 6124-97;

5° The preparation, distribution and storage, essential to the immediate availability, of the health products, medicinal treatments and equipment required to carry out the functions provided for in 1° to 4°;

The function mentioned in 3° must be carried out in the protected interventional unit mentioned in II of this article.

IV.-The interventional sector with controlled access is equipped with the means to guarantee the quality and safety of the procedures performed. In particular, it ensures:

1° Guidance of procedures, where appropriate;

2° Monitoring and maintenance of vital functions;

3° Performance of surgical procedures;

4° Access by staff to medical information required for treatment;

5° Management of complications;

V.-The interventional sector has a specific organisation and the means to ensure:

1° The planning of human resources;

2° The programming of interventions;

3° The traceability of each intervention and the therapies used;

4° The recording and analysis of any malfunctions linked to the activity;

5° The prevention and management of risks linked to the activity, in particular as part of the fight against undesirable events provided for in articles R. 6111-1 et seq.;

6° Compliance with the rules, standards and recommendations in force regarding the control of airborne contamination, asepsis, air treatment and hygiene, in line with the specific therapeutic practices mentioned in II of article R. 6123-202 and the type of procedure performed by the authorisation holder.

VI.-The interventional sector is organised in such a way as to enable the management and regulation of:

1° The care activity carried out in the interventional unit;

2° The management of the flow of patients, staff, products and equipment, and information;

3° The management of the use of the interventional unit's intervention rooms;

4° Quality and safety of care.