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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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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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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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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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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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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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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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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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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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)

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Thank you for your attention!

HERCA: Heads of the European Radiologicalprotection Competent Authorities

1 herca: heads of the european radiological protection competent authorities – working group...

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