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Transcript of 1 HERCA: Heads of the European Radiological protection Competent Authorities – Working Group...
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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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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
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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
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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
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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
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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
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HERCA WG Medical Applications
Clinical Audit
Basis: standards and good practice
Outcomes: recommendations and suggestions
Organisation: peer review systems
Teams: professionals
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Key aspects of clinical audit
- auditors are independent
- audit teams are multi-disciplinary
- audit content is comprehensive (not just radiation protection)
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HERCA WG Medical Applications
Inspection
Basis: legislation and regulation
Outcomes: requirements and enforcement
Organisation: legal mandate
Teams: inspectors and advisors
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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)
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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
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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
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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)