Background information on clinical audit

As part of clinical governance, healthcare organisations are accountable for continually improving the quality of their services. Clinical audits are inextricably linked to quality and, if correctly and professional conducted, a powerful tool to improve patient care, experience and outcome. They consist of measuring a clinical outcome or procedure against defined standards in order to identify differences between current practice and the given standards. Clinical practice can thus be evaluated. If the standard is not achieved, reasons for this are explored, changes are implemented based on the results and a re-audit is carried out to ensure improvement. This methodology is often described in terms of the audit cycle.

Methodology: the audit cycle

If audit means comparing an element of clinical practice against an agreed standard, in radiological practice this might mean what we do, how we do it, what equipment we use, how we interact with our patients, our colleagues and our environment. To put it in another way, audit asks one question: ‘are we safe?’

Audit should be Achievable, Local, Practical, Inexpensive, Non-threatening, and Easy (ALPINE).

Audit carried out within departments (‘internal’ or clinical audit) can also provide evidence to prepare and support departments that are also undergoing ‘external’ audit which generally equates with inspection by a regulatory authority. Carrying out clinical audit ‘in accordance with national requirements’ is mandatory within the European Union from February 2018 as a result of implementation of the updated Basic Safety and Standards Directive. The updated BSS Directive (COUNCIL DIRECTIVE 2013/59/EURATOM) (1) has major implications for European practice in several areas, including documented justification processes for radiation exposure, and dose optimisation. In addition, it requires that ‘clinical audits are carried out in accordance with national procedures’. In whatever form the new legal framework is implemented (and there is inevitably national variation), internal clinical audit within departments helps individual departments to comply with legislation, to monitor their own practice and to be well prepared for any external audit.

Clinical audit is central to modern medical practice, involving reflective validation of existing practices, and identification of potential changes and improvements, in the interests of patient safety and better outcomes.

The ESR perspective on clinical audit

The ESR cooperates with institutions including the European Commission and the Heads of the European Radiation Protection Competent Authorities (HERCA) to ensure that clinical audit is applied properly to improve quality of patient care in Europe, but also to understand the regulators’ perspective for its efforts regarding audit.

In the context of the implementation of the Basic Safety Standards Directive, the ESR works with stakeholders to increase awareness of clinical audit among radiologists and to provide radiology departments with a toolkit to perform audits effectively.

Clinical Audit - ESR Perspective Read the ESR Audit and Standards Subcommittee paper on clinical audit for more information.

The ESR Clinical Audit Tool

The ESR Clinical Audit Tool is designed to facilitate the development of local clinical audit across the spectrum of the services provided by clinical radiology. It provides an outline of the principles of clinical audit combined with a library of templates for audit in a variety of situations, as well as a compendium of useful resources.

According to Dr. Adrian Brady, Chair of the ESR Quality, Safety and Standards Committee, Clinical audit is central to modern medical practice, involving reflective validation of existing practices, and identification of potential changes and improvements, in the interests of patient safety and better outcomes. Radiology practice is ideally positioned to utilise the tools of clinical audit.

The ESR aims to build on this initial publication of the Audit Tool by developing further standards with supporting templates.

The ESR standards aim to address the following questions:

  • Is your service safe?
  • Is your service responsive?
  • Is your service caring?
  • Is your service effective?
  • Is your service well led?

The ESR Clinical Audit Tool contains a draft blank template which can be adapted according to local or national audit topics, a series of suggested regulatory audit topics, and a series of clinical audit topics. It is an excellent basis for commencing the practice of clinical audit in imaging departments, and for developing audit in those departments already active in this area’.

The ESR Clinical Audit Tool has been published under the name of 'Esperanto booklet'. See below for more information.

The Esperanto booklet

The ESR Audit and Standards Subcommittee has produced Esperanto - a guide to clinical audit in radiology and clinical audit tool - under the chairmanship of Adrian Brady and Barry Kelly in collaboration with EuroSafe Imaging. First published in 2017, this guide is designed to support radiology departments in developing a clinical audit programme. This project was led by E. Jane Adam and supported by EuroSafe Imaging and the ESR Office.

An enhanced version of Esperanto was developed under the guidance of Adrian Brady and David Howlett. It contains an expanded audit guide with an additional focus on the legal requirements around audit, and an increase in audit templates.

The Esperanto booklet was named after the most successful constructed language in the world, Esperanto, created by the Polish ophthalmologist Ludwik L. Zamenhof, and offers an overview of the ESR Clinical Audit initiative.

List of regulatory and clinical audit topics

Regulatory audit topics

1. Is there a departmental machanism for providing patients (or their representative) with information relating to the risk/benefits associated with radiation dose from the medical exposure?

2. Is there an established mechanism within the department to register and analyse accidental /unintended exposure?

3. Is there a departmental policy for informing patients, or their representative, that they have undergone and accidental exposure?

4. Is there a mechanism for record keeping and retrospective analysis of accidental or unintended medical exposures?

5. Is there a mechanism for referring accidental exposure events to the medical physics expert (MPE) and informing the competent authority of significant events?

6. Does the department utilise criteria, provided by the relevant radiation protection competent authority, for what constitutes an accidental or unintended significant exposure?

7. Is there evidence for appropriate training for individuals with delegated responsibility (in the case of non-radiologists) for the justification process?

8. Is there a departmental machanism to confirm and document the non-pregnancy status of individuals undergoing medical exposures?

9. Is there a written protocol for the identification of who is responsible for the justification process?

10. For radiation exposure related to health screening by invitation on asymptomatic individuals, is there a local policy affirming justification by a competent authority?

11. What percentage of examinations involving ionising radiation are justified in advance of being performed?

12. What mechanism exists on the request form for contacting referrers to permit pre-exposure justification discussions to occur if necessary?

13. Is there a written protocol for who may be responsible for justification of X-ray /fluoroscopic /interventional ionising radiological procedures?

14. Is there a written protocol for who may be responsible for justification of CT examinations?

15. What mechanism is used to evaluate patient dose in high-dose procedures?

16. What percentage of radiodiagnostic procedures have established diagnostic reference levels (DRL)?

17. Specific technical requirements for equipment in use for medical exposures.

18. Eye lense dose limits for occupational exposure.

19. Initial education and training in radiation protection.

20. Audit of education plus training in radiation protection, doses and side effects.

21. Provision of clinical information to support justification.

22. Staff dosimetry audit - this includes a draft adapted questionnaire.

23. Evaluation of the role and reponsibilities of the medical physics expert.


Clinical audit topics

1. Does the radiology department record statistics about patient satisfaction?

2. Waiting time for outpatient ultrasound appointments

3. Protocols around radiological procedures, information in reports

4. The practice of "routine" preoperative chest x-ray

5. Audit of inpatient chest x-rays or abdominal x-rays

6. What percentage of non-ionising imaging studies (MR/Ultrasound) are consistent with the referral guidelines?

7. Pain sensation during image-guided interventions

Blank audit and audit templates

For the purposes of this audit project, we have produced a blank audit template which we hope will assist each responding department to familiarise themselves with the process. The 23 regulatory audit templates and 7 clinical audit templates can also be downloaded separately.

Contact information:

ESR Office
Am Gestade 1
1010 Vienna