1. 1 HERCA: Heads of the European Radiological protection Competent Authorities – Working Group Medical Applications Clinical Radiology Audit Forum 2015 18 May 2015, London Euratom: European Regulators’ Views on Clinical Audit S Ebdon-Jackson Public Health England

2. 2 HERCA WG Medical Applications ME Directive 97/43/Euratom Article 6 and BSS Directive 2013/59/Euratom Article 58: “Member States shall ensure that clinical audits are carried out in accordance with national procedures” - clinical rather than medical audit - flexibility NBthe definitions refer to systematic review, improvement, quality, examination against standards, modification or new standards but do not include external activity

3. 3 HERCA WG Medical Applications European Commission (2009). European Commission Guidelines on Clinical Audit for Medical Radiological Procedures (Diagnostic Radiology, Nuclear Medicine and Radiotherapy). Radiation Protection Series 159 Lead contractor – STUK (Finland) Sub-contractors – GMC of Westfalen-Lippe, BNMS UK, RPC Lithuania

4. 4 HERCA WG Medical Applications RPS 159 Chapter 5: Interrelation of clinical audit with other audit systems - overlap and duplication should be avoided - focus on non-mandatory issues of clinical practice Chapter 6: Interrelation with regulatory control - overlap and duplication should be avoided - focus on legal requirements

5. 5 HERCA WG Medical Applications RPS 159 Demonstrates existence of and a role for - internal audit - external audit - internal audit with external direction NB - external influence provides a broader perspective - there may be a role for a combination of types of audit

6. 6 HERCA WG Medical Applications Post Directive 2013/59/Euratom European Radiation Protection Regulators believe clinical audit is increasingly important as a tool to demonstrate: Quality services Regulatory compliance - justification - optimisation BUTInspection and audit are different Both are required

7. 7 HERCA WG Medical Applications Clinical Audit Basis:standards and good practice Outcomes:recommendations and suggestions Organisation:peer review systems Teams:professionals

8. 8 HERCA WG Medical Applications Key aspects of clinical audit - auditors are independent - audit teams are multi-disciplinary - audit content is comprehensive (not just radiation protection)

9. 9 HERCA WG Medical Applications Inspection Basis:legislation and regulation Outcomes:requirements and enforcement Organisation:legal mandate Teams:inspectors and advisors

10. 10 HERCA WG Medical Applications Key aspects of inspection - inspectors are independent - inspection teams are expert in regulations but not necessarily in the areas they inspect - inspection content is restricted (must relate to regulations)

11. 11 HERCA WG Medical Applications Audit and inspection can address the same subjects, while still avoiding overlap Justification - inspection addresses process and responsibilities - audit addresses appropriateness through assessment of imaging’s impact on healthcare management of patients Optimisation - inspection verifies QA programmes, protocols, DRLs etc are in place - audit addresses impact on diagnosis and patient dose of changing protocols etc

12. 12 HERCA WG Medical Applications Regulators’ responsibility for and interaction with clinical audit - not involved in undertaking audits - ensure audits are taking place; as required by national regulations in accordance with national procedures - have access to audit reports if required (eg during inspection) - ensure positive aspects of audits are implemented

13. 13 HERCA WG Medical Applications Regulators’ perspective on clinical audit – summary - carrying out audits is a regulatory requirement and audit activity should be verified and considered as part of inspection - basis, outcomes, organisation and teams for audit and inspection differ and overlap should be minimised - audit plays a significant role in improving radiation protection (as well as other aspects of clinical care) - different audit methodologies exist across Europe and harmonisation does not appear to be necessary (or practicable)

14. 14 Thank you for your attention! HERCA: Heads of the European Radiological protection Competent Authorities