SErIES IAEA HumAn HEAltH SErIES IAEA Hum

1.1.3. Confidentiality of audits
Confidentiality is a critical issue in relation to clinical audits. It is essential
that all parties, those being audited and those carrying out an audit, respect the
confidentiality of patient data, interviews/discussions with staff and audit
checklist/performance data. Patient confidentiality should be respected, and,
whenever possible, anonymized patient information should be provided to the
audit team.
Confidentiality will facilitate the discussion of important QA issues. The
information obtained and evaluated as part of clinical audit should therefore be
regarded as peer review information and hence not be discoverable by third
parties. The clinical audit report is the formal public document describing the
visit and its findings.
1.1.4. Borderline between clinical audit and other related activities
Owing to their wide general purpose and multidisciplinary nature (see
Section 1.1.1), external clinical audits in diagnostic radiology bear a close
relationship to other quality assessment systems, such as certification of quality
assessment systems and accreditations, and also to regulatory inspections of
radiation protection and safety. However, it is of high importance to understand
that clinical audit is different from these other quality assessment systems. While
the practical procedures can be partly similar, there are clear differences in the
focus of the evaluation, as well as in the consequences of the results of the
observations. While the exact borderline is dependent on the national
infrastructure and provisions for quality assessments, clinical audit should be
considered as supplementing and not duplicating the other efforts.
The focus in clinical audits is, as a peer review activity, always on the
clinical issues of the service, where comparisons with clinical good practice are
relevant, and the results are recommendations with no inherent obligation on their
implementation. Regulatory inspections address the legal requirements and can
lead to enforcement actions if practices do not comply with requirements. Quality
audits for the certification of quality systems are directed towards checking the
conformity of the local quality system to the given quality standard, and do not
directly ensure the good quality of the practices in terms of clinical judgements.
Audits carried out for accreditation may in certain respects come closest to the
objectives of clinical auditing, but they are often limited to standard procedures
where definite standards are available.
Legal requirements and international basic safety standards in relation to
radiological procedures require QA programmes for medical exposure, which in
turn impose requirements on audits of aspects of these programmes [4]. Such
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