Medical Applications - Addendum to the HERCA Position Paper on Justification
Addendum to the HERCA Position Paper on Justification
"HERCA recommendations on the transposition and implementation of BSS requirements concerning the application of justification principle for medical examinations using ionising radiations" (published in July 2014) 1
On 22 October 2014, on the occasion of the 14thmeeting of the association HERCA which brings together the Heads of European Radiological protection Competent Authorities, HERCA has approved an Addendum to the HERCA Position Paper on Justification "HERCA recommendations on the transposition and implementation of BSS requirements concerning the application of justification principle for medical examinations using ionising radiations "
Justification of individual medical exposures for diagnosis is a key principle of radiation protection :
- for choosing the most appropriate examination to be performed for any given patient;
- for reducing or eliminating clinically unhelpful radiological /nuclear medicine examinations.
On 3 July 2014, HERCA published on its website a position paper on justification. That paper was intended to provide clarity on the regulator’s approach to roles and responsibilities concerning justification and considered a number of factors associated with the justification process.
As part of the transposition process for Council Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionizing radiation (BSS-Euratom), National Competent Authorities should assess the efficiency of national regulation introduced for the transposition of the justification requirements of the previous directive (Directive 97/43 Euratom) and, if needed, update this regulation taking into account chapter VII of the BSS-Euratom, particularly articles 55 (justification), 57 (responsibilities) and 58 (procedures).
HERCA believes that the transposition of the directive 2013/59 Euratom offers a unique opportunity to implement in the national regulations procedures addressing the justification process. So, Regulators should ensure that the process of justification follows written formal procedures in each imaging department which should clearly define the responsibilities assigned to each individual (referring clinician, radiologist/nuclear medicine physician and other professionals including technologists).
The approved addendum to the position paper on justification approved in July 2014 includes practical actions that can be taken by Member States and the responsible undertakings to ensure appropriate transposition and implementation of Council Directive 2013/59/Euratom and to ensure good practice throughout the justification process.
HERCA suggests that the written formal procedure describing the process of justification could be a requirement of a quality management system dedicated to radiological examination, including the quality assurance programme on equipment, as mentioned in article 60.c of the BSS-Euratom. In practice, such a procedure could address the following issues : referral guidelines, request and report of examination, computerized decision support systems, education and training, self reporting of justification deviations.
HERCA Addendum Position Paper on Justification (Oct. 2014)
Publication date: 21-11-2014