Clinical auditing is one of those practices that radiologists know they should do but most don't -- kind of like flossing every night. To determine the awareness, status, and role of a clinical audit within European member states, the European Society of Radiology (ESR) commissioned a survey that found most don't have a firm grasp of the concept.
In 2009 the European Commission (EC) published its Guidelines on Clinical Audit. The document included a definition of a clinical audit, which is akin to quality assurance but not quite the same thing -- the aim is continuous improvement rather than a pass/fail approach.
Clinical audits in relation to ionizing radiation and treatments are compulsory in the EU, but specific recommendations are not. In fact, the EC said the recommendations for clinical audits are "not binding and the actual frequency and the methods for audit may, and will, vary from state to state."
ESR summarizes the EC guidelines in an article published online this month in Insights into Imaging (May 8, 2011). Key points from the EC guidelines:
Audits should be carried out on structure, processes, and outcome.
Audits should be carried out in a no-blame manner. The aim should be to improve services, not a pass/fail approach.
Audits should be performed in a confidential environment.
Audits should be conducted by suitably qualified professionals, such as radiologists, radiographers, and medical physicists.
Internal audits should be performed annually within each organization, with an external audit every five years by a visiting team of professionals.
- Regulatory bodies should neither carry out clinical audits directly nor exclusively set up the criteria for them, but there should be the development of special auditing organizations, preferably nonprofit organizations supported by professional and/or scientific societies.
Auditors should have received suitable training and be accredited by a national accrediting body. International audit services may be used.
In the ESR's survey, which had a 100% response rate, nearly two-thirds (61%) of member states said only a minority of radiologists understood the concept of a clinical audit and the specific methodology to be used. In addition, 66.67% of member states said they were not in a position to comply with the requirement for an external audit of diagnostic radiology, nuclear medicine, and radiotherapy.
"Only a minority of states is ready to comply, but it is not clear whether even this minority is confident that they are in a position to fulfill all the detailed requirements of the guidelines," the ESR stated in its article.
Funding also is an issue, with most societies assuming the state will pay for audits rather than individual institutions, although the EC favors the latter.
"Audit should not be a threatening process, but one that all parties can accept as being a learning and development tool," the ESR said.
The ESR also offers two approaches to implement the audit guidelines: top down or bottom up. They suggest either instituting a comprehensive clinical audit system at the national level, which would encourage individual institutions to fulfill the requirements, or to spread awareness of clinical audits and to use the methodology locally at a departmental level. From there the system would become national.
"There is still much developmental work required before clinical audit is widely practiced in member states, and Europe-wide uniformity of understanding and practice of audit can be achieved," the ESR said. "The EC guidelines seem aspirational rather than achievable in the short term for most member states, but the statutory requirement for clinical audit must be fulfilled, and this may lead to closer adherence to the detailed EC guidelines on how it is best implemented."