Clinical Audit in medical radiological practices

HERCA publishes a position paper on clinical audit in medical radiological practices to address requirements for and differences between clinical audit and inspection. 

Clinical audit is an important tool for the delivery of high quality healthcare. Recognising this, the EC Basic Safety Standards Directive (BSSD) 2013/59/Euratom includes a requirement that Member States shall ensure that clinical audits are carried out in accordance with national procedures.

This is consistent with a similar requirement in the EC Medical Exposure Directive 97/43/Euratom. The concept of clinical audit within the area of medical exposure is not new.

HERCA became aware of some lack of understanding within the radiological community on how regulatory requirements for clinical audit should be met.

Results from a coordinated inspection week on justification in radiological medical imaging facilities (HERCA European Action Week) performed in November 2016 revealed that the concept of clinical audit is not fully understood and rarely performed within medical imaging. Review of national regulatory frameworks among the participating countries also indicated that clinical audits were not fully implemented at a national level.

This document is intended to address requirements for and differences between clinical audit and inspection, as specified in Articles 58 and 104 respectively, of the current BSSD 2013/59/Euratom, and to express the views and expectations of the regulator regarding clinical audit.

HERCA would like to express its gratitude to the European Society of Radiology (ESR), the European Association of Nuclear Medicine (EANM), the European Society for Radiotherapy and Oncology (ESTRO) and the International Atomic Energy Agency (IAEA) for their contribution on this position paper.