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Clinical Radiology Audit Forum 2015 18 May 2015, London

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.

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Clinical Radiology Audit Forum 2015 18 May 2015, London

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

  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 • NB the definitions refer to systematic review, improvement, quality, examination against standards, modification or new standards but do not include external activity       

  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. 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. 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. 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 • BUT Inspection and audit are different • Both are required

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

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

  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. 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. 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. 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. Thank you for your attention! HERCA: Heads of the European Radiologicalprotection Competent Authorities

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