prEN XXX

Quality along the patient pathway in medical imaging prEN XXX

Scope

This document defines the requirements for the implementation of a quality approach in medical imaging (MI) organisations along the patient pathway.
It includes:
- patient care before the examination (appointment making, patient information, validation of the request, patient reception, etc.), during the examination (adoption of the principle of optimization, response to adverse events etc.) and after the examination (patient monitoring, MI procedure report, transmission of results, archiving, etc.) with the integration of basic principles (confidentiality, safety, hygiene, identity vigilance,..) .
- the corresponding human resources and technico-medical requirements
- quality and risk management.
Interventional radiology, radiology using mobile units and telemedecine are also part of the scope.
The best practices description will be used for clinical audits. Nevertheless, the clinical audits methodology will not be covered as it is already defined at European level and its implementation is the responsibility of each country. Requirements related to equipment and radiation protection controls are also excluded as already covered.