**6. Current status of dosimetry audit in the member countries of the european federation of organizations for medical physics (EFOMP)**

The European Union has issued a new directive on the use of ionizing radiation for medical purposes 2013/58 / EURATOM, which entered into force in 2014 [18]. The new Directive updates the basic standards for radiation protection in clinical and professional settings, emphasizes clinical audits, reinforces their importance for quality improvement and recommends, that Member States ensure that dosimetry audits are carried out in accordance with national audit procedures.

A clinical audit is defined as "a systematic review or review of medical radiological procedures that seeks to improve the quality and outcome of patient care through a structured review in which medical radiological practices, procedures and outcomes are performed against established standards for good medical radiological procedures. procedures, changing practices where appropriate and applying new standards if necessary."

Dosimetry audits are one of the main measures introduced to ensure the safety of patients undergoing radiotherapy. The international organizations conducting clinical trials set as a condition for participation the results of the dosimeter audit in order to evaluate the clinical dosimetry in the specific radiotherapy center, with it participated in the clinical trial [19]. In this way, dosimetry quality assurance (QA) and quality control (QC) are doubled as a tool in the fine-tuning used in clinical trial technology [20].

Performing an external dosimetry audit is an expensive procedure that requires special knowledge, skills, actions, time and effort. In some countries, basic safety standards require regular dosimetric audits with different requirements and frequencies.

The audit documentation of radiotherapy centers participating in an international clinical trial is not always easy to obtain and analyze because it is heterogeneous in terms of the type and frequency of dosimetric audit and is different for different centers and countries in Europe.

All this is the basis of the European Federation of Organizations for Medical Physics (EFOMP) to initiate a survey to determine what kind of audit, clinical or dosimetric, is required by law in different European countries, what role the medical physicist plays and to get a general idea for the regulations and practices regarding the quality assurance and quality control of the radiotherapy equipment.

EFOMP is developing a questionnaire in order to obtain the necessary information on the general requirements and standards for organizing and conducting dosimetric audit, quality assurance of dosimetric activity and periodic dosimetric inspections in EU countries at the end of 2019. The questions are addressed to the community of medical physicists to assess the regulatory status of dosimetric audits performed in radiotherapy centers.

The questionnaire was sent to 33 National Member Organizations (NMOs) in November 2019 (at the time of the survey's dissemination, 33 NMOs were part of EFOMP). The results were obtained in the period December 2019–March 2020.

The first section of the questionnaire refers to the requirements for conducting periodic dosimetric audits in radiotherapy centers in Europe, the subject (auditor) performing the audit according to national legislation, as well as the source of the auditor (internal / external).

19 NMOs (58%) of the 33 EFOM members replied to the questionnaire. Of these, 14 are EU Member States (54%) and 5 are non-EU (46%).

In eleven European countries (11/19 NMOs), 9 EU members and 2 non-EU countries, national regulations require regular dosimetric audits to be carried out in radiotherapy centers (See **Figure 2**).

*Dosimetry Audit in Modern Radiotherapy DOI: http://dx.doi.org/10.5772/intechopen.100941*

**Figure 2.**

*Dosimetric audit requirements according to the NMO responses [20].*

Dosimetry audits are performed as follows: by external auditors in (6/11 NMOs), by internal auditors (2/11 NMOs) and by an unspecified auditor in (3/11 NMOs). 42% (8/19 NMOs), of which 5 EU members and 3 non-EU countries state that the requirements for conducting a dosimetric audit are not regulated at national level.

Only 11 NMOs report that national regulations require regular dosimetric audits of radiotherapy centers, but only 6 European countries state that there are wellestablished procedures that must be followed for an audit to be valid. Dosimetric audit is of great interest to EFOMP and is given great importance in Council Directive 2013/59 / EURATOM. Overall, the EFOMP study shows significant heterogeneity in national policies on the dosimetric audit program of radiotherapy centers.

Dosimetric audits were conducted in only 58% of the countries (NMOs) that participated in the survey organized and conducted by EFOMP in November 2019, although the deadline for transposition of the European Directive 2013/59 / EURATOM into national legislations is the end of 2019.
