The ESR Basic Patient Safety Standards and Audit Tool provides clear guidance on how to perform effective audit against 17 Patient Safety Standards that the ESR considers essential good practice in any imaging service. These standards encompass all aspects of patient safety, with a particular focus on radiation protection of the patient. To support departments in auditing their practice, the ESR Audit and Standards Subcommittee has produced a set of templates to help radiologists and radiographers assess their compliance with each of the standards.
Clinical Audit is required under the Euratom Basic Safety Standards Directive and therefore mandatory in the EU. The ESR Audit Tool aids departments in carrying out audit, thereby complying with the directive and assuring the protection of their patients.
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 Clinical Audit Tool 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 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:
The ESR's 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.
The ESR Clinical Audit Tool will be available for download here soon.
The Euratom Directive (COUNCIL DIRECTIVE 2013/59/EURATOM) will have 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 will inevitably be national variation), internal clinical audit within departments will help individual departments comply with legislation, monitor their own practice and be well prepared for any external audit.
The ESR Audit & Standards Subcommittee has prepared an initial set of 17 audits with simple templates to complete. Some require data collection by the department, some simply require that a written protocol is in place. Five of these are considered to be essential.
The ESR Audit & Standards Subcommittee in collaboration with EuroSafe Imaging has developed a pilot project to test the 17 audit templates within the network of EuroSafe Imaging Stars. This project is led by Dr E. Jane Adam and supported by the ESR Audit & Standards Subcommittee, EuroSafe Imaging and the ESR Office.
The main goal of this pilot project is to test the audit templates and amend them if needed based on the feedback received from the project’s participants. Thereafter, the ESR Audit Pack will be made available to European imaging departments.
In the pilot, imaging departments are asked to carry out five specific key audits (numbers 4, 8, 14, 15 and 16) and as many of the other 12 audits they wish to do over a period of three months. The five essential audits are considered key because they span the gamut of audit topics, likely to be of immediate relevance to an imaging department.
Clinical audit is a tool designed to improve the quality of patient care, experience and outcome through a formal review of systems, pathways and outcomes of care against defined standards, and the implementation of change based on the results. As part of clinical governance, healthcare organisations are accountable for continually improving the quality of their services. Clinical audit, correctly and professionally conducted, is a powerful tool to improve patient care, experience and outcome.
Audit simply 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 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 audit) can also provide evidence to prepare and support departments that are also undergoing external audit or inspection. Carrying out clinical audit ‘in accordance with national requirements’ will become mandatory within the European Union from February 2018 as a result of implementation of the updated Euratom directive. This focuses on radiation exposure and protection, with a particular emphasis on processes for justifying all radiation exposures and minimising dose. The legislation will be interpreted differently in different member states, but the establishment of internal clinical audit in key areas will help departments to be ready for whatever external system is implemented in their country.
For the purposes of this pilot project, we have produced a blank audit template which we hope will assist each responding department to familiarise themselves with the process.
The five essential audit templates can also be downloaded separately.
1. What is the departmental mechanism for informed consent?
2. Does the department record statistics on the number of accidental /unintended exposures that occur annually?
3. What is the departmental policy for informing patients that they have undergone an accidental exposure?
5. What is the mechanism for referring accidental exposure events to the medical physicist expert (MPE) and informing the competent authority?
6. Does the department have criteria for what constitutes an accidental or unintended exposure?
7. If the justification process is delegated to an individual other than a radiologist, has that person undergone appropriate training?
9. Is there a written protocol for the justification of who is responsible for the justification process?
10. For radiation exposure related to health screening, is there a policy affirming justification by a competent authority?
11. What percentage of studies are justified in advance of being performed?
12. What mechanism exists 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 fluoroscopic/interventional radiological procedures?
17. What percentage of procedures have established dose reference levels (DRL)?