As the use of radiation in medicine is still the biggest contributor to radiation exposure caused by man,
improving and maintaining a high quality of radiological medical procedures is of primary importance.
The EC Directive 97/43/EURATOM introduced the concept of Clinical Audit for the assessment of medical radiological practices and the requirement that all Member States should implement clinical audit in accordance with national procedures.
Since 2011 within the frame of the "National Programme for Monitoring Environmental Life and Work Determinants,
Objective 2 - Health care and prevention of diseases associated with ionizing radiation",
the National Institute of Public Health started the national project "Clinical audit of medical ionizing radiation practices".
The project originally aimed at developing for the first time a national procedure to perform the clinical audit in the practice of diagnostic and interventional radiology in accordance with current national and international regulations and then implementing it in radiology departments at national level.
The preliminary clinical audit procedure developed on the basis of IAEA Publication “Comprehensive clinical audits of diagnostic radiology practices: a tool for quality improvement.
Quality assurance audit for diagnostic radiology improvement and learning” (QUAADRIL),
2010 [1] was applied as a pilot study in a few representative medical institutions in Cluj-Napoca,
in 2011 – 2015.
After applying this preliminary clinical audit procedure:
- have been identified numerous benefits when applying clinical audit in radiological practice,
the most important being the improvement of radiological medical services in terms of quality of care and patient radiological protection;
- have been highlighted a series of important problems concerning organizational and infrastructure issues related to the practical implementation of clinical audit at national level.
Thus,
every year,
the project objectives have changed,
focusing on addressing the identified issues.
Since 2014 it has been identified as a need the development of a national legislative act regarding the implementation of clinical audit in radiological medical practices,
in the context of transposition into national law of Directive 2013/59/EURATOM [2] and the most recent international specific recommendations.
So,
the entire project was carried out in parallel on two inter-dependent components:
Component I - aimed the application of the preliminary audit procedure as a pilot study in representative health care facilities from Cluj-Napoca,
as an iterative process in order to:
- assess the current radiological practice and compare it with selected international standards;
- determine the final form of audit procedures based on feedback obtained from the pilot study.
Component II - with the following objectives:
- the development of a draft for a legislative act regarding rules on clinical audit in radiological medical practices,
by the specialists of the National Institute of Public Health;
- the development of national good-practice guidelines based on the most recent international recommendations,
by the medical professional societies.