Subsection 17: Nuclear medicine

I.-The holder of a “B” nuclear medicine authorisation pursuant to Article R. 6123-135 has an in-house pharmacy authorised to carry out the activity provided for in 6° of Article R. 5126-9 and, where applicable, a hospital sector whose rooms, where applicable radioprotected, are connected to decay tanks for the collection of effluent contaminated by radionuclides. II.-The authorised nuclear medicine site includes a defined area with at least the following spaces:…

Where the site has an in-house pharmacy, the preparation of radiopharmaceuticals must be carried out under its supervision.

The authorised nuclear medicine site has the following equipment: 1° An emergency trolley for the treatment of patients requiring it; 2° Equipment for waste and effluent management in accordance with the provisions of article R. 1333-12.

I.-The holder of the “A” authorisation pursuant to Article R. 6123-135 shall have a team comprising: 1° At least one doctor specialising in nuclear medicine present on site during patient care; 2° At least one medical electroradiology technician present on site during patient care; 3° At least one doctor authorised to carry out stress tests present on site during stress tests. The holder of the authorisation must ensure that a…

The role of the radiopharmacist provided for in article D. 6124-189 is to ensure the safety of the radiopharmaceutical medicine circuit and includes in particular: 1° Carrying out control actions relating to the preparation and holding conditions of these medicines; 2° The supply of medicines, products and objects mentioned in article L. 4211-1 and sterile medical devices. The radiopharmacist participates in the development and implementation of the quality process in…

Staff working in the delimited area where radiopharmaceutical preparations and controls are carried out receive appropriate initial and ongoing training in radiopharmacy and radiation protection for staff, patients, the public and the environment.

The equipment on the site authorised under the conditions of Article R. 6123-136 is connected to a system for archiving and sharing images and to a system for archiving and analysing doses. The report given to the patient specifies the dosimetric data concerning him or her.

The authorisation holder is subject to the obligation of quality assurance defined in I of Article L. 1333-19.

The provisions of paragraph 1 of sub-section 9, with the exception of those of II of article D. 6124-131, are applicable to the holder of a nuclear medicine qualification with grade B when carrying out therapeutic cancer procedures involving the administration of radiopharmaceuticals.