| Licence holder | Australian Nuclear Science and Technology Organisation (ANSTO) |
| Location inspected | Lucas Heights Science and Technology Centre |
| Licence number | F0309 |
| Inspection date/s | 18-20 September and 14 November 2023 |
| Report number | R23/08072 |
This is the record of an inspection conducted as part of ARPANSA’s planned 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 F0309. The scope of the inspection included an assessment of ANSTO’s performance at the ANSTO Nuclear Medicine (ANM) Facility against the following areas from the Facility Performance Objectives and Criteria (FPOC); effective control, safety management, security, and emergency planning. The inspection consisted of a review of records, interviews, and physical inspection of the facility including the Quality Control (QC) laboratory.
Background
The ANM facility is used for large scale production of Molybdenum-99 (Mo-99). Mo-99 is the precursor of Technetium-99m (Tc-99m) which is used in approximately 80% of all nuclear medicine procedures. The Mo-99 is extracted from low enriched uranium targets, processed, packaged and despatched to ANSTO’s Health Products facility for use in ANSTO Tc-99m Generators as well as for overseas radiopharmaceutical facilities.
The main codes and standards applicable to this licence are:
- RPS C-1 Code for Radiation Protection in Planned Exposure Situations (Rev 1) (2020)
- RPS 11 Code of Practice for the Security of Radioactive Sources (2019)
- RPS C-2 Code for the Safety Transport of Radioactive Material (2019)
- RPS C-6 Code for Disposal of Radioactive Waste by the User (2018)
Observations
Effective control
The effective control plan for the ANM facility had been reviewed and updated in November 2022. The facility is operating in accordance with ISO 9001, 14001 and 45001. The certificates for these standards were reviewed.
Process implementation
The ANM facility uses a risk-based approach in the development of processes; an example is the process developed to audit the suppliers. Depending on the nature of what is being supplied, the audit process could range from a desktop review of the supplier profile and management system or could it be a physical inspection or audit.
Documentation and document control
ANM uses commercially available software as a document control system. The software facilitates the routine review of documents and supports the change management process. The software records the document owner, controls who has ability to change the document, and tracks which documents are related.
The current Quality Control (QC) process consists of three main procedures. A sample of these were reviewed and no deviations that would have significance to safety were identified. The ANM facility is aiming to transfer to a fully automated QC process early next year. Although the process is still being developed it was available for observation during this inspection. The change management process to implement this has commenced.
Safety management
Safety policy and objectives
ANSTO safety policy and objectives apply to ANM and no deviations from the overarching policy were observed. ANM aims to prevent events and has recently been taking proactive actions to identify and address areas that could result in safety incidents or accidents.
Monitoring and measurement
ANSTO has a process for reporting the events that occur within the facility. This is managed using commercially available software. The ANM procedure stipulates that events should be closed in 6-7 days. A sample of events where there was potential for radiological impact to occur were reviewed. It was observed that some events remained open for up to four months. This occurred due to the need to perform more investigation into complex events, and as such, the extended timeframe is justified. While it is desirable for events to be closed quickly it is acknowledged that this needs to be balanced with the need to fully and properly investigate what did happen and what could have happened so that corrective and preventative actions can be implemented. ARPANSA encourages licensees to fully understand and learn from minor events as a means of preventing more serious accidents.
An event previously occurred at ANM that involved ANSTO’s proprietary flask system. The investigation conducted by ANM identified that operators were required to simultaneously follow four different procedures at the same time. This came about because each piece of equipment had its own procedure. A learning that ANM took from the event was to integrate the procedures into an overall task demonstrating a commitment to continuous improvement.
Managing change
ANM has a formal process for managing change which is tailored specifically for Nuclear Medicine production and applies to changes which may affect safety. It uses an electronic system that facilitates the lifecycle of the change from the creation of the change request, change review, impact assessment, implementation, verification and finally to close out the case of change. An example of how changes are managed was reviewed. This example was the transition to a fully automated QC process. This is a substantial change that ANSTO has not yet completed. Nevertheless, no shortfalls were identified.
Security
Security procedures
The previous inspection of security at ANM focussed on, what at the time was, the newly drafted and approved ANM Facility Security Plan (FSP) and its implementation. Overall, the level of understanding and awareness of the protective security system has increased since the last inspection when considering the operational experience gained over that period of time and the uplift across a number of elements of the security system. The updated FSP is considered comprehensive and addresses what would be expected for a facility such as the ANM.
ANSTO Nuclear Security and Nuclear Safeguards (NSNS) undertook an extensive review and update of the ANSTO Security Risk Assessment (SRA) and has since been endorsed by the Executive and the ANSTO Board. The SRA will be rolled out and implemented across all ANSTO licenses, including ANM, given it is a key decision-making tool in ensuring the application of effective and appropriate controls. In that regard, it is expected that during the next review and update of the ANM FSP, the new ANSTO SRA will be used as the basis of the FSP.
The following elements of the protective security system were reviewed (via documentation) and discussed in detail: governance arrangements (including risk and vulnerability assessments), training, personnel security, building access elements, information security, performance of the protective security system (including maintenance, faults and repairs, among other), response arrangements (including drills and exercises), cyber security and the safety – security interface. A walk through of the facility was conducted where particular attention was given to the I&C Room, the Communications Room and ‘red’ radiological areas on the ground floor.
From the limited scope review of ANM’s protective security system, the assessment shows the protective security system follows the approved ANM FSP and meets the ARPANSA performance objectives and criteria for ANM.
Emergency preparedness and response
Categorisation for emergency planning
ANSTO has assessed the emergency planning for the ANM facility using two different approaches. The outcome of one approach is contained within the Safety Analysis Report (SAR) which classifies ANM using a framework that was withdrawn by ARPANSA prior to March 2018. A greater awareness of changes to documents published by ARPANSA or international bodies is encouraged. This is identified below as an area for improvement as ARPANSA has since adopted international best practice in its place. For emergency preparedness, this is considered to be IAEA GSR Part 7 Preparedness and response for a Nuclear or Radiological Emergency (2015). This has been supplemented at the National level by RPS G-3 Guide for Radiation Protection in Emergency Exposure Situations (2019) which presents a consistent approach to IAEA GSR Part 7. ANSTO has also assessed the facility against this framework. This was recorded in a Technical Note (ANSTO/RPS/TN/2017-13) in December 2017 and the ANM facility is classed as emergency preparedness category (EPC) II. This document indicates ‘this EPC will be reviewed in line with the ANSTO Nuclear Medicine (B88) Radiological Hazard Assessment and Protection Strategy’ (ANSTO/RPS/TN/2017-11). Although Inspectors were advised that the ANM emergency preparedness category has not changed, no supporting documentation (such as a new technical note) was provided to demonstrate a formal review was undertaken.
Emergency plans and procedures
ANSTO has numerous documents relating to emergency planning. These are written at the organisational level, site level, and facility level. It is desirable to have comprehensive and harmonised documents to assist workers in managing emergency situations. Consequently, it is noted that the ANSTO Emergency Management Plan (AG-5945) does not reference ANM in the ANSTO Subplans shown in Table 4 of that document. Section 5.1.2 of the ANM Emergency Plan indicates that there are a range of alarms for initiating a response to an incident within the facility. While critical safety alarms (such as a fire alarm) are automatically relayed to ASOC, ANM staff are also trained to investigate alarms and assess whether it is safe to return to normal operations or escalate the alarm by manually reporting the issue to ASOC. Inspectors note ANM alarms may serve different purposes, with some alarms intended to reflect the status of a system. ANM has introduced a visual colour coded system which overlay audible system alarms to aid in the interpretation and response to alarms in operating a complex facility such as ANM which could impact emergency response and consider this good practice.
Emergency drills and exercises
A series of emergency response drills have been undertaken as part of a coordinated exercise/drill schedule. ANM is using a scenario-based approach to develop staff and organisational planning and preparedness for possible emergencies. Drills for each scenario are undertaken several times to maximise the chance that staff on each shift can experience the hypothetical events and learn to address and overcome the situation. Response times are measured as a key performance indicator for the Emergency Response Team (ERT). The response times are compared against the indicative Response Time Objectives (RTOs) for a radiological emergency that are set out in the ANSTO Emergency Management Plan: Lucas Heights Campus Emergency Plan (AG-5950). ANSTO was unable to provide this data during the inspection. Nonetheless, inspectors were informed by ERT that the RTO for ANM have
been met. However, the measured response times are not being compared against the assumptions in the risk assessment and used to inform future versions of the risk assessment to ensure that the risk assessment is grounded with values that are realistic or conservative. Furthermore, it has previously been observed at OPAL reactor exercises, that independent observers using an ‘Emergency exercise observation checklist’ have been present. This checklist is used to record alarm and response times. A similar approach may be useful for ANM, and in any case, communication between facilities and harmonisation of processes is encouraged. This is highlighted as an area for improvement below.
Inspectors noted the value of scenario testing with ANM and ERT collaboratively engaging in the development of a range of probable events involving realistic scenarios. In addition to exercises identifying emergency response equipment needs and testing capability; ANM consider the exercise program is an invaluable mechanism for relationship building between ANM staff and responders which has improved overall performance. It is evident that ANSTO has learned valuable lessons by conducting exercises and drills. These have covered; the capacity of different technologies to be used to support emergency communications, meeting and escorting responders and proving them with a brief of the situation they are approaching; preparing a cache of radiation detection equipment that can be collected during an evacuation and taken directly to the external muster point to conduct clearance surveys of ANM staff.
Leadership for emergency response and preparedness
ANSTO has trained multiple staff to fill the role of Incident Controller (IC). All nine ICs have completed the Level II incident training. Toolbox talks are utilised as a means by which an IC can share their personal experience from participating in an exercise or involvement in an incident with other staff members on the IC roster.
ERT has taken the initiative to install PPE equipment inside new response vehicles to streamline their response times for incidents at facilities across the Lucas Heights campus. In addition, ERT is conducting gap analysis to identify potential areas where emergency response capability can be improved. For example, assessing the need for a specialised vehicle with foam delivery system to respond to a substation fire. Furthermore, lessons learned during tabletop exercises designed to workshop plausible ‘what if’ scenarios are used to create action items to drive continuous improvement in emergency response.
External event protection
It is normal practice for safety assessments to be performed that identify natural and human induced events that have the potential to affect the safety of the facility. Bushfire is a type of external event that is commonly considered when performing this type of assessment. ANSTO has considered a bushfire in its risk assessment for the facility, along with the potential for fires in the hot cells and the building. However, the ANSTO SAR does not discuss the bushfire threat in detail. While the ANM facility is ostensibly constructed of building materials with low combustibility this is a notable absence given the ANSTO site is largely surrounded by bushland and the ANM building itself is close to the bush. This, in combination with other observations, is identified as an area for improvement below.
ANSTO completed an annual bushfire checklist in June 2023. This is used to prepare for bushfires and extreme weather. However, this was not done in 2022. This, in combination with other observations, is identified as an area for improvement below.
The NSW State Government has changed the alert levels for bushfire risk and ERT will consequently review the ANSTO Emergency Management Plans and arrangements for bushfire risk. This, in combination with other observations, is identified as an area for improvement below.
Findings
ANSTO was found to be in compliance with the requirements of the Act, the Regulations, and licence conditions.
The inspection revealed the following area/s for improvement:
- Maintain awareness of changes to documents published by ARPANSA or international bodies and implement any consequential changes in a timely manner.
- Better alignment of the different documents associated with emergency planning.
- Harmonise the arrangements for conducting exercises for similar types of facilities, including formalising the observation of exercises by independent observers, including the Regulator(s), and using a formal observation sheet to independently record evidence of meeting facility RTOs.
- Strengthen the documentation and the arrangements for mitigating the effects of bushfire on the facility.
The inspection revealed the following good practice:
- Adopting a visual and audible system to distinguish different alarms which aims to improve communication during an emergency response.
It is expected that improvement actions will be taken in a timely manner
