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and 8 on patient safety in radiotherapy published in
2015 concerning the recording faults in the Record and
Verify systems andpulsedhighdose rate brachytherapy).
In addition, recommendations were addressed to all
radiotherapy departments inMay 2015 inorder toprevent
the occurrence of radiation protection events associated
with beam asymmetries in external-beam radiotherapy
and to improve their detection.
5.3 Radiation protection situation
in radiotherapy
The safety of radiotherapy treatments has been a priority
area of ASN oversight since 2007. In view of the results
of the inspections and the progress made in terms of
treatment safety, as of 2012 radiotherapy centres will
be checked every two years. An annual inspection
frequency is nevertheless maintained for the centres
with vulnerabilities in terms of human resources or
organisation, and those which are behind schedule in
ensuring compliance with ASN resolution 2008-DC-0103
of 1st July 2008. Moreover, particular attention is paid
to departments having undergone major modifications
(organisational or material), and centres implementing
new techniques.
A four-year inspection programme had been defined for
the 2012-2015 period with systematic inspections and
variable inspections for the 2012-2013 and 2014-2015
periods respectively.
Over the 2014-2015 period, the inspectors focusedmore
particularly on:
•
the management of jobs and skills of the personnel
assigned to dosimetry and of the radiographers assigned
to the preparation of treatments and patient set-up
during the simulation;
•
the management of the equipment (quality control,
maintenance);
•
the management of treatment preparation and
performance (appropriateness of the procedures and
their implementation during treatment preparation
and the verification of positioning during treatment).
5.3.1 Radiation protection of radiotherapy
professionals
When the facilities are correctly designed, the radiation
protection implications for the professionals in radiotherapy
are limited due to the protection provided by the walls
of the irradiation room.
In2014 the inspectors inspected themethods of verification
and maintenance of the radiotherapy and computed
tomography facilities:
•
72% of the centres inspected had formalised the
maintenance and verification methods in writing;
•
the number of quality controls of scanners (applied
during treatment preparation) has increased significantly
since 2010, since 93%of the centres inspected carried
out this quality control in 2014.
Performance of the internal quality control and external
quality control of external-beam radiotherapy facilities
must be audited by an approved organisation. Three
organisations are now approved to perform this audit, the
first having been approved inAugust 2013. Nevertheless,
in 2014, 41%of the inspected centres had not yet had this
audit performed, or placed an order with an approved
organisation to have it performed.
ASN moreover verifies the radiation protection
requirements for the personnel when it delivers the licenses
to possess and use the devices, particularly during the
facility conformity inspection.
5.3.2 Radiation protection of radiotherapy patients
The ASN inspections carried out in 2014 concerned
92 centres, representing nearly 52% of the radiotherapy
departments. They confirm the positive trend begun
in 2008 with regard to the increased human resources
deployed in medical radiation physics. At the end of
2014, all the centres had more than one Full-Time
Equivalent (FTE) medical physicist. Nevertheless,
ASN counts 19 centres with less than two FTE
medical physicists, and in 5 centres the inspectors
noted temporary situations where the presence of a
physicist was not guaranteed for the entire duration
of the treatments.
Implementation of a quality management system
Although the implementation of a management system
for the safety and quality of care delivered to patients is
progressing, it varies greatly from one centre to another
and some are still late with respect to the regulatory
deadlines set by ASN technical resolution 2008-DC-
0103 of 1st July 2008.
The results of the inspections performed in 2014 show
in particular that:
•
3% of the inspected centres had not designated an
operational quality manager (compared with 29% in
2011 and 11% in 2013); however, when a quality
manager is appointed, the means at their disposal to
fulfil their mission are not always defined (in 10% of
the centres inspected);
•
93% of the centres inspected have a mapping of the
processes;
•
although 87% of the centres inspected have defined
care quality and safety objectives, in 12%of the centres
these objectives are not all tracked and/or updated;
•
49% of the centres perform internal audits and
process reviews but 31% of the centres only conduct
a management review and 20% of the centres have
still not defined continuous improvement methods;
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CHAPTER 09:
MEDICAL USES OF IONISING RADIATION
ASN report on the state of nuclear safety and radiation protection in France in 2015