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The effects of the Brazilian regulatory inspection programme on nuclear medicine facilities
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Abstract
This paper aims to demonstrate the importance of the regulatory inspections
carried out by the Brazilian regulatory body in the area of nuclear medicine.
The main aspects observed during the inspections are presented as well as the
time evolution of the non-compliances, according to their occurrence by type.
We also evaluate factors concerning the working of the nuclear medicine facility
responsible for solving the non-compliances. The results suggest a decrease of
occurrence of non-compliances with time that can be related to the strictness
of the inspections and the awareness of the personnel in the nuclear medicine
facilities. An analysis of radiation dose exposure levels for the professionals
involved in nuclear medicine was carried out; although dose values are below
regulatory dose limits, their occurrence is not decreasing satisfactorily. Results
indicate the need for staff training and commitment of the responsible nuclear
medicine facility staff to the radiological protection procedures. Our results
also emphasise the importance of continuous coercive actions to improve the
level of radiological protection in nuclear medicine facilities in compliance with
the standards established by the national regulatory authority and international
recommendations.
1. Introduction
The Brazilian nuclear regulatory body, namely the National Commission of Nuclear Energy
(CNEN), following international recommendations [1–5], is the organisation in charge of the
licensing and control of nuclear and radioactive practices and installations in the country.
Within its organisational structure there is a division in charge of groups that regularly inspect
and evaluate licensed installations in different industrial and medical fields. In this context,
there is a trained group specifically dedicated to inspecting nuclear medicine facilities.
During the licensing process [6, 7], a prior inspection is performed to guarantee that the
construction and working area classification comply with the previously approved project that
was submitted to CNEN as part of the process of obtaining the first authorisation to operate.
On-site inspections of the installation take place every 2 years during which several radiological
protection aspects are analysed according to a 126-item checklist, and their compliance with
national regulations and standards is verified.
Among the large variety of items evaluated during inspections, four main categories have
been chosen due to their major impact on the radiological protection of a nuclear medicine
facility. As a direct consequence of the doses delivered to patients, the occupational doses
to workers, the dose to the public in general and the environmental impact are also analysed.
The doses to patients are not analysed in this work, since they are outside the scope of CNEN
inspections. Some efforts have been made since 2008 to evaluate and establish guidance levels
in nuclear medicine procedures around the country.
This work was developed with the aim of analysing the effectiveness of inspections of
nuclear medicine facilities in Brazil in the period from 1996 to 2006 [8].
2. Non-compliances of interest
The four items chosen for analysis in the present work were obtained over a long period, from
1996 to 2006, to guarantee the continuity of inspection in each facility and representative non-
compliance evaluation statistics. These items are:
According the Brazilian regulations all professionals who work with radioactive materials
should be individually monitored. The Brazilian Radiation Protection and Dosimetry Institute
in Rio de Janeiro has created a national database that controls this individual monitoring. The
database system considers the following approaches related to occupational doses:
• Annual effective dose limits adopted by the regulatory authority [9].
• An anytime effective dose of 4 mSv as a threshold for investigating occupational high dose
values.
• An anytime effective dose of 100 mSv to start in vitro investigation.
The Brazilian regulatory authority, CNEN, has adopted the BSS-115-IAEA recommended
dose limit [1, 2] since 2005. As a consequence, an investigation level of an effective dose of
1.0 mSv/month or a value of 6.0 mSv/year for workers in routine procedures has been adopted.
During the inspections, the occupational doses are investigated and, if some of them are higher
than this limit, it is checked whether the investigation was carried out by the installation’s
personnel and if the proposed solutions have been implemented. As the new limits were
adopted in 2005, facilities are now adjusting their optimisation process accordingly.
When the effective dose limits are outdated or a high dose value is observed, higher than
4 mSv, the radiation protection officer must send to CNEN an investigation report explaining
the causes of this dose value and the new procedures adopted to prevent further events. In the
case of doses above 100 mSv, besides the investigation report, an in vitro study must be carried
out.
4. Results
In this section the main data collected during the Brazilian regulatory inspection programme
for a 10-year period, from 1996 to 2006, are presented. The time evolution of the number of
non-compliances per installation is also showed, as well as the number of inspections carried
out and the number of persistent non-compliances.
After a positive outcome as a result of the sanctions introduced in the early years of this
study, in 2001 a quality assurance programme was introduced for the regulatory body and the
inspectors were given extensive training to carry out their work under this new vision. Since
then, some new items of compliances have been introduced in the checklist and, as result, an
increase in non-compliances was observed in 2002.
Figure 1. Frequency of nuclear medicine installations that have non-compliances associated with
surface contamination records (solid bars) and exposure records (empty bars).
where νi is the number of facilities presenting the non-compliance of interest and S is the total
number of facilities inspected per year. The term f i indicates the percentage of installations
presenting this non-compliance in a certain year. The index i is related to one of the four
non-compliances of interest described above. Namely,
i = 1: surface contamination and exposure records;
i = 2: surface contamination and survey meter calibration certificates;
i = 3: radionuclide dose calibrator and gamma camera quality control programmes; and
i = 4: radioactive isotope manipulation procedures.
In figure 1, f 1 is displayed as a function of the inspection year. It can be observed that the
non-compliances decreased considerably from 1996 to 2001, oscillating around a frequency
of 30%. The solid bars are related to surface contamination and empty bars to exposure
records. Once this non-compliance has been directly related to the lack of a culture of
executing the measurements or, in the worse case, to a total non-execution of the procedure, a
large frequency of 30% can be associated with the absence of training in preparation for the
professionals to execute and register the measurements. In these cases, the regulatory authority
should act coercively by limiting the installation licensing conditions, by reducing the period
of authorisation to operate as well as by restricting the amount of radioactive isotopes to be
furnished to the installation.
It can be observed that there was a rapid decrease in exposure measurements and records
between 1996 and 2001. After that, with an exception in 2002, an almost constant value of
around 20% is obtained. This value is still considered too high, and it is also related to the
safety culture and the commitment of the radiation protection officer to keeping records of all
measurements.
In figure 2 f 2 , the non-compliances associated with updated calibration certificates of the
instruments, surface contamination meters (solid bars) and exposure meters (empty bars) are
presented. It can be observed that, despite the increasing pattern from 1996 up to 1998, these
non-compliances decreased until 2001, indicating an effective response to inspections. After
2001 another frequency increase can be observed that may be explained by the limited number
of certified calibration laboratories able to perform instrument calibrations in the country. This
problem persisted until the period 2005–2006, when a constant value of almost 20% of the
installations still presented this non-compliance.
512 C E G R Alves et al
Figure 2. Frequency of contamination instruments (solid bars) and survey monitors (empty bars)
presenting out of date calibration certificates.
Figure 3. Frequency of deficient radionuclide dose calibrators (solid bars) and inappropriate gamma
camera quality control (empty bars), as a function of the year of inspection.
Non-compliances associated with the quality control of the radionuclide dose calibrator
are presented as solid bars in figure 3. Although the coercive regulatory actions and a large
number of training courses for nuclear medicine staff were available in this field in Brazil,
this special item presents a small level of improvement in radiological protection since around
35% of the facilities have an inefficient quality control programme. This problem raises a very
important radiation protection point, because since 1996 the radiation protection officer does
not seem to have been concerned about quality control procedures for equipment. Once the
accuracy in the activity measurement is related to the patient dose and, consequently, to the
radiological protection of the patient, new and strong enforcement actions should be planned
by the regulatory authority to reduce the frequency of this non-compliance.
The frequency of non-compliance associated with gamma camera quality control, empty
bars in figure 3, is evidence that the quality control programmes in a general way have been
neglected by the radiation protection officer and nuclear medicine physicians. Since dose
control and the checking of all image tools are requirements for an adequate and safe diagnosis,
they are peremptory controls in a nuclear medicine facility. A way to improve the facility
control procedures is to support governmental organisations like the Brazilian Institute of
Radiation Protection and Dosimetry in providing training courses in different regions all over
the country with the objective of helping the majority of facilities, emphasising the importance
of quality control and assurance programmes, to offer a good quality service to the population.
The effects of the Brazilian regulatory inspection programme on nuclear medicine facilities 513
Figure 6. (a) Persistence of the total non-compliances observed during annual inspections.
(b) Frequency of persistence of non-compliances of interest observed in annual inspections.
per year, where the persistence concept can be applied only to installations that have been in
operation for at least 2 years. It is clearly seen that the number of persistent non-compliances
is approximately constant from 2002 up to 2006, being around 45%. This is evidence that
although the regulatory inspection programme has reached its primary goal, there are still some
failures in the licensing process and regulations allowing some installations to persist with the
same non-compliances for several years.
Figure 7. Annual effective dose of all nuclear medicine facilities observed during inspection per
year.
Figure 8. Maximum effective doses observed in nuclear medicine facilities per year.
officer related to some incident or accident are also checked. Figure 7 presents the effective
occupational doses verified during inspections as an average for all installations. The data are
available only from 2000 when this non-compliance started to be reported during inspections.
It can be observed that the annual mean effective dose values are always below the annual
limits but are, in some cases, still above the investigation levels of 6 mSv/year, where the
optimisation of radiological protection procedures is recommended. To achieve that, the
necessary investigation and measurements are checked during the inspections to certify that
they are adequately established.
The maximum effective dose per year is also examined, but this involves a different
approach. If the regulatory dose limits are exceeded, a reactive inspection is carried out to
verify the radiological protection conditions in which this unjustified dose occurred.
Figure 8 shows the maximum effective dose values observed since 2000. It can be seen that
only in 2002 was there no record above 20 mSv. After investigation, it was concluded that the
cause of these high dose values was always an error in the manipulation of sources and patients
or in the source storage system. Here, again, the occurrence can be explained by a failure of
staff training and by an absence of commitment to radiological protection procedures.
Despite the efforts of the regulatory body, the doses database is not yet related to the
facilities yet and access to doses values is by worker identification. As workers usually change
their employment, the task of directly linking personal doses to an specific installation is not
possible. Since 2008, the doses database has been under revision to provide this possibility for
occupational dose control.
516 C E G R Alves et al
References
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The effects of the Brazilian regulatory inspection programme on nuclear medicine facilities 517
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