|Inspection report details
|Date/s of inspection:
|8-9 December 2020
An inspection was conducted as part of ARPANSA’s baseline inspection program to assess compliance with the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act), the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations), and conditions of facility licence F0251.
The scope of the inspection included an assessment of ANSTO’s performance at Camperdown against the Performance Objectives and Criteria (POCs). The inspection consisted of a review of records, interviews, and physical inspection the facility.
ANSTO’s Camperdown facility houses a commercially available 18 MeV cyclotron used for the production of both carbon-11 (C-11) and flourine-18 (F-18) from irradiated targets. The cyclotron is housed within a heavily shielded bunker and is operated remotely from a control room. The facility makes use of various hot cells, laboratories and other rooms to prepare radiolabelled compounds. These C-11 or F-18 compounds are powerful but short lived radiation sources with a half-life of 110 minutes and 20 minutes respectively. This research focussed facility collaborates with the University of Sydney’s Brain and Mind Centre and other centres and falls under the banner of ANSTO’s Nuclear Science & Technology and Landmark Infrastructure (NSTLI) cluster.
The main codes and standards applicable to this facility are those that appear in section 59 of the Regulations plus:
Performance reporting and verification
Following previous inspections, ARPANSA inspectors sought to discuss areas for improvements (AFIs) and other areas of interest. These discussions covered a number of areas:
- the cause of target ruptures was analysed using ANSTO’s subject matter experts, the original cyclotron manufacturer and collaborative partners
- maintenance planner training has not yet occurred
- ventilation issues leading to movement of airborne radioactive contamination has been rectified
- inclusion of the feedback loop for training is progressing
- and hazard identifications are currently being added to procedures.
In terms of the hazard identification being added to procedures, AFIs were identified from a Camperdown inspection but were focussed more broadly at ANSTO as an organisation where the facilities would learn from each other in order to implement a more standardised approach. Staff informed inspectors that communications have occurred between facilities but the approach to providing warnings within procedures has not yet been standardised (e.g. communication of radiological consequence). From a human factors perspective, some safety warnings adopted within procedures sound punitive rather than being directly related to safety due to the inclusion of statements which mention either removal from or reduction of work. Another example placed emphasis on a risk to delayed work that should not be emphasised in a safety warning. While it is acknowledged that this is still a work in progress, it is expected that ANSTO continues to develop this in line with the aforementioned and accepted AFIs.
Inspectors also noted that although the plans and arrangements are currently within the mandated review period (3 years), ANSTO’s requirements continue to stipulate annual review and need to be updated. This is considered an AFI.
Recent events raised in quarterly reports were also discussed. A transport event recently occurred where radioactive liquid (sludge) waste was to be packaged and transported to the Lucas Heights campus (ANSTO main site). The management of safe transport of radioactive material has previously been a compliance issue at the facility as packages have previously been sent without appropriate labelling, dangerous goods declaration, and with the courier unaware of the nature of the materials being transported. While similar issues have been flagged in regard to this recent event, as there is still an open internal investigation into the matter it would be inappropriate to speculate on the results of findings not yet determined. Nevertheless, it is clear that the management of safe transport of radioactive material is an AFI.
As a result of incidents and accidents at ANSTO, there has been greater focus on developing solutions that optimise processes to mitigate or eliminate the occurrence of radiological consequences to staff and therefore reduce the overall risk of performing certain activities. This has been primarily focused on radiochemistry quality control activities where staff come into contact with highly concentrated samples of radioactivity in the order of GBq/ml.
As a result of an improvement notice issued to Camperdown it is now mandatory that radiation attenuating gloves be used when performing manual radiochemistry work involving unsealed sources. While the use of such personal protective equipment (PPE) has been tested and modelled in order to provide a level of confidence that doses will be reduced, implementation of PPE is at the bottom level of the hierarchy of controls. The use of PPE offers the lowest level of protection, is the least reliable, and does not control the hazard at its source. It also relies on staff compliance in order for it to be effective and is generally implemented as a last resort, an interim measure, or to increase effectiveness of higher-level controls. This is highlighted in ANSTO guidance (G-7522: Risk Management of Unsealed Radioactive Sources – Biosciences) which states that PPE must be considered as the last line of defence and higher levels of controls must be implemented.
In the development of the most recent safety assessments and safety analysis report – in response to licence conditions – many recommendations were made by ANSTO’s Safety Systems and Reliability group to make further improvements to the safety of the facility, its operations and its staff. Many of these point to optimising the process at higher levels. While the majority of recommendations have been accepted by the facility, the detail surrounding the process of optimisation at the facility is not completely clear. Further to this there is potential for the inclusion of a licence condition on Camperdown that will focus on the optimisation of processes in the facility as has been attached to other ANSTO facilities which perform similar activities and therefore have similar risks.
Inspection, testing and maintenance
Maintenance activities at Camperdown for the most part occur in the form of breakdown maintenance. Preventative maintenance as it relates to the cyclotron is essentially the replacement of interchangeable parts as a result of a component reaching the end of its useful life or a drop in performance. Evidence was provided during the desktop inspection of the results of hot cell servicing and maintenance as performed by Global Medical Solutions who are the contracted service provider. As the scientific equipment (hot cells, the cyclotron, etc) are not entered into ANSTO’s global maintenance system (SAP), though their maintenance strategies are, the facility keeps a record of such maintenance at the local level. When the aforementioned training for maintenance planning takes place the facility will be able to use the SAP platform for its maintenance needs.
Due to COVID the facility entered a shut-down period where no radiological work was performed. It was then decided that maintenance activities could be delayed as a result of inactivity essentially extending the lifetime of components by that period. While these activities are recorded in a spreadsheet the detail explaining the delay is not.
Inspectors also verified that testing of interlock functionality in relation to the hot cells and cyclotron had been performed at its nominal quarterly frequency.
ANSTO uses its Learning Management System (LMS) to track general ANSTO training such as radiation safety workshops and refreshers as well as organising confined space and working-at-heights training among others. Managers are able to view the current curriculum of each staff member they are directly responsible for to determine whether or not training is up-to-date. Outside the LMS, the Camperdown facility manages area specific requirements through a training matrix.
With the exception of a new-starter, training requirements appear to be up-to-date.
Analysis of the impacts of multiple external events is detailed in the safety analysis report (SAR) for the facility. It details how the building has been designed and built to appropriate codes and the likelihoods of potential vulnerabilities. As such the worst case radiological exposure in one of these events is bounded by an assessment which considers a release of a full inventory of freshly irradiated target material irrespective of any contributing factors external to the facility. ANSTO deems the likelihood of external events, as detailed in the SAR and derived from analysis, to be low.
In order to mitigate consequences of some foreseen potential external events ANSTO ensures firefighting equipment, pest control and external flood pumps are routinely maintained.
Following on from previous inspections, arrangements regarding the implementation and management of security of the facility remain unchanged.
Findings from recent events that occurred at other ANSTO facilities point to issues with dosimetry (for example, wrist dose used primarily as a measure of extremity dose may not correlate to extremity dose (i.e. at the fingertips)). As a result of recommendations made to address issues raised following the drafting of new risk assessments for the facility, a study was tasked with assessing dose from manual radiochemistry operations to ensure monitoring was being conducted appropriately. This was to commence earlier this year, with both wrist and finger dosimetry issued to those who undertake such manual work, until COVID ceased such operations. This has recently recommenced in the fourth quarter of this calendar year; however, new PPE (radiation attenuating gloves) has been introduced to mitigate potential extremity doses and therefore effective doses are expected to be lower and not representative of those prior to the change. The radiation protection advisor attached to the facility advised that the study would still continue to assess the dosimetric impact made by the gloves.
Certificates of calibration for radiation protection equipment were provided as were copies of radiological assurance surveys. Calibrations were found to be within date and surveys were performed as required with the exception of those due to be undertaken in the COVID shutdown phase as no radiological work was performed.
Emergency preparedness & response
An AFI from the last inspection (November 2019) was identified for emergency preparedness and response in broad terms. Since then the issues identified (with the exception of that which related to the plans and arrangements) have all been actioned and remedied.
The facility is required to undertake an annual emergency drill to exercise the arrangements in place. Following the aforementioned AFI, the facility has had additional compressed air breathing apparatus (CABA) equipment supplied and are all currently within their servicing requirements. Due to additional potential non-radiological hazards (hydrogen sulfide, H2S), staff have been further trained in the use of CABA and wish to test their response in case a release of H2S should occur. Though the exercise is planned to be conducted early in the new year to ensure the exercise is planned and tested adequately, this will mean that the facility has slightly lapsed its annual requirement. This contributes to the first AFI in relation to keeping up to date with internal requirements.
The licence holder was found to be in compliance with the requirements of the Act, the Regulations, and licence conditions.
The inspection revealed the following areas for improvement:
- Keeping up-to-date with internal requirements.
- Ensuring the safe transport of radioactive material.
It is expected that improvement actions will be taken in a timely manner.