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Clinical Radiology Audit Forum 2015 18 May 2015, London

Explore the significance of clinical audits in radiology practice as perceived by HERCA, European Radiological Protection Authorities. Learn about the role, organization, and outcomes of clinical audits compared to inspections. Discover key aspects, responsibilities, and perspectives on regulatory compliance and quality improvement.

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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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