SErIES IAEA HumAn HEAltH SErIES IAEA Hum

audits are part of clinical audit but cover only a limited part of a comprehensive
clinical audit. The results of these audits should be reviewed and utilized in
carrying out a comprehensive clinical audit in the context of these IAEA
guidelines.
Further information on the relationship of clinical audit with regulatory
inspections and other quality assessment systems is given in the clinical audit
guidelines published by the Commission of the European Communities (CEC)
[5] for the improved implementation of the requirement on clinical audits given
in CEC directive 97/43/Euratom [2]. The CEC guidelines also contain
information on many practical aspects of establishing a sustainable system of
clinical audits to cover all three disciplines of the medical uses of radiation
(diagnostic radiology, nuclear medicine and radiotherapy), and can be used to
supplement the guidance given in these IAEA guidelines.
1.2. PURPOSE AND SCOPE
Advice about quality practices has formed an integral part of the advice
provided by the IAEA [6]. Such practices have a basis in statistical sampling [7]
and have long been an integral part of industrial processes, and more recently also
in the assessment of clinical practice [8]. Donabedian [8] has described three
approaches to clinical practice assessment, which can be classified under three
categories: structure, process and outcome:
(1) Structure denotes the attributes of the settings in which care occurs. This
includes the attributes of material resources (such as facilities, equipment
and finance), of human resources (such as the number and qualifications of
personnel), and of organizational structures (such as organization of
medical staff, methods of peer review and methods of reimbursement).
(2) Process denotes what is actually done in giving and receiving care. It
includes the patient’s activities in seeking care and carrying it out, as well as
the practitioner’s activities in making a diagnosis and recommending or
implementing treatment.
(3) Outcome denotes the effects of care on the health status of patients and
populations. Improvements in the patient’s knowledge and salutary changes
in the patient’s behaviour are included under a broad definition of health
status, as is the degree of the patient’s satisfaction with care received.
Clinical audit should ideally cover the three categories above. In external clinical
audits, structure and process can be well covered; however, assessment of outcome
is more difficult in diagnostic imaging. For effective assessment of the outcome,
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