Inspection report: ANSTO Health Products, F0262, 19 - 21 August and 3 September 2024

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 F0262. The scope of the inspection included an assessment of the performance of the licence holder, ANSTO Health Products, against the following areas of the Facility Performance Objectives and Criteria: Effective Control, Safety Management, Security, and Emergency Plans. The inspection consisted of a review of records, interviews, and physical inspection of the facility.

Background

Health Products manufactures and distributes radiopharmaceuticals and radiochemical products to the Australian and overseas markets. The products which are produced by Health Products are typically used for the diagnosis and/or treatment of disease (including cancer). The most commonly produced product is the molybdenum-99/technetium-99m generators which are used by hospitals and medical clinics across the country. 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 Safe Transport of Radioactive Material (2019)

Observations

For the last three years Health Products has been examining and challenging the high risks associated with the facility. There were initially 36 high risks, many of which had existed for decades. These risks have been reviewed and ANSTO has identified ways of decreasing the number of high risks. There are currently 5 high risks. This is an admirable effort to optimise the risk profile associated with the facility and is commended.

Effective Control

ANSTO Health Products’ Plans and Arrangements (P&A) document provides the description of systems and processes in place that manage safety and security in the facility. The documents reviewed during the inspection were found to be current. The responsibilities outlined in the documents were clear and well understood by the relevant persons which was demonstrated in interviews with the staff and management. 

The licence holder reports to ARPANSA on statutory and regulatory requirements quarterly in accordance with the relevant licence conditions. A sample of the events that have occurred in the facility over last 12 months was inspected in more detail. ANSTO Health Products uses the ANSTO organisation wide GRC system to manage information associated with events. The records examined showed that ANSTO investigated the events appropriately and in accordance with ANSTO guide AG-2375 Incident Investigations. The GRC system showed only three open events, which is a significant drop over the last few years. All three events were recent, and their investigations are ongoing. This is considered positive progress given that a quick investigation with appropriate action implementation can minimise the risk of an event recurring. 

A relatively small number of open events potentially indicate that events are closed before they are properly investigated. Therefore, further probing of closed events was conducted. The inspection showed a good level of record details, adequate level of investigation was achieved, and lessons learned and implementation actions were identified and carried out. 

The event associated with the External Liquid Waste Interim Storage (ELWIS) tanks was examined more closely due to a related breach of s60 of the Regulations identified in 2023. ANSTO’s event investigation report identified 6 recommendations that the licence holder committed to report to ARPANSA quarterly. The records of periodic visual inspections of the tanks showed they had been conducted, however the records showed a relatively low level of detail. For example, the photos presented in the reports lacked proper descriptions and the tasks missed time stamps. Therefore, the evidence of the required visual inspections claimed to be completed could not be verified. This is an area for improvement. 

ANSTO intends to transfer management of Building 54 and the ELWIS tanks to the ANSTO Waste Management Services (WMS) facility licence. Therefore, some projects that have been implemented to address the recommendations have not recently shown progress due to ANSTO’s preparation for the transfer. This was understandable and accepted by the ARPANSA inspectors. 

Near miss involving Lutetium-177 (Lu-177) 

This inspection discussed a number of events. However, particular attention was paid to a near miss that occurred inside a biohazard cabinet within the microbiology laboratory. The event related to the spillage of microdroplets of liquid containing Leutitium-177. There was no gross spill or splash of radioactive material but, due to a mix-up with the sample being tested, the liquid had a high activity concentration.

Higher than expected levels of contamination were found on tools and the disposable paper that lined the biohazard cabinet. However, when the worker’s outer layer of gloves was measured in a low-background area, they showed no contamination. From this it can be concluded that there was negligible actual dose received as a consequence of the event, but it could potentially have had significant consequences, including injury due to high skin dose. 

The two workers directly involved in the event had very limited experience. While they followed procedures, and conducted contamination monitoring, it was a third laboratory worker with more experience who noticed the higher-than-expected contamination levels. On two occasions this worker suggested Health Physics support be requested and, after the second suggestion, the outer layer of gloves was changed. After approximately 45 minutes a fourth worker entered the laboratory and noticed that the work had been undertaken on the incorrect sample and that there was substantially more radioactivity present than specified by the procedure. However, the decision was made to clean the biohazard cabinet and continue the process. Health Physics support was not requested until 3 hours after the event and took 30 mins to arrive at the laboratory. ANSTO guidance suggests staff should initially stop and think when they encounter a problem. ANSTO’s investigation into the event identified that this did not happen. It is encouraged that action is taken to ensure workers understand that the corporate support services, such as Radiation Protection Services, are there to support and assist them and they should be comfortable and confident to call on them.

ANSTO categorises laboratories and other areas where radiation is used so that the magnitude of the hazard can be clearly communicated. There are three categorises, which in escalating order of hazard are white, blue, and red. These categories are applied to both the external radiation hazard and the contamination hazard. The laboratory where this event occurred is categorised as ‘blue’ for both external radiation and contamination hazard levels. The methodology for categorising areas considers external exposures, the intake of radioactivity by ingestion or inhalation, and workers being exposed to contaminated surfaces, however it does not consider exposures to skin. To consider the inclusion of skin exposure in the categorisation methodology, consistent with the safety assessment, is identified as an area for improvement. 

Since this event, ANSTO has changed the movements of the vials so that vials for different tasks are not present in the laboratory at the same time and cannot be confused. In addition, ANSTO has implemented multiple improvements such as amending the procedure to confirm the radioactivity being worked on is correct. There is further scope to provide workers with specific guidance for how to respond to potential events based on examples. It is expected that all staff working with radiation are suitably trained, qualified and experienced for any unsupervised work they are performing. ANSTO has a basic radiation training course. This course is intended for staff that are new to ANSTO and/or new to working with radiation. The workers involved in this event had undertaken this training. There is also a second training course specifically on radiation safety at Health Products. This is far more detailed and specific to the hazards that are present in the workplace. The workers involved in this event had not undertaken this training. This was done according to the existing procedures as this specific training is normally delayed so as not to overwhelm the new worker with information without sufficient operational context. This event has raised questions around this approach, specifically training time frames and supervision arrangements. Therefore, the existing approach to supervision and current timeframe to complete training relevant to radiation safety is an area for improvement. Following the event, ANSTO undertook an investigation and identified actions to prevent its reoccurrence. There is a standard template to investigate any accidents, incidents, near misses and safety observations. The template has space for actual and potential consequences to be recorded. Three potential consequences were identified based upon the volume of liquid contamination on the worker’s skin and the timeframe before it was removed. However, no ‘best estimate’ or ‘conservative estimate’ of potential dose was recorded based upon the actual timeline of the event. Ensuring the reviewer understands the potential dose consequences of an event enables a proportionate response. The template also has space to undertake a ‘5 whys’ root cause identification. This is a commonly used tool for understanding what went wrong in an event. By repeatedly asking ‘why’, investigators can identify and then address the root cause of the event. To do this, sometimes the question ‘why’ needs to be asked more than 5 times. However, the template shows space for 4 ‘why’ questions to be asked which may hinder the identification of the actual root cause if further spaces are not added by the user. This event highlighted areas where the template itself could be strengthened and this is an area for improvement.

Safety management

As Health Products operates a nuclear installation that produces radiopharmaceuticals it is expected to have a substantial and tightly controlled business management system comprising numerous documents detailing how the business is run and how deviations will be addressed. A snapshot of the system showed that two safety-related records were overdue for review. They are related to portable radiation monitors and the processing of low volume irradiation targets. No discernible radiological consequence could be identified due to the delay in the review of these documents. Although the management system showed these minor inconsistencies it is still considered to have a high rate of conformance with the review schedule. 

Safety can be influenced by technological, human and organisational factors. The Independent Review of ANSTO Health undertaken in October 2018 discussed psychosocial hazards in the context of how they related to radiation safety at the time. Coincident with this is an increasing awareness of the role of psychosocial hazards in the workplace more generally in Australia. ANSTO has undertaken safety culture perception surveys of Nuclear Medicine (which includes ANSTO Health) in 2018 and 2022. Since the outcomes from the latest survey aligned with actions already in progress, no additional action plan was developed this time. It is acknowledged that work is occurring in the meantime, such as the consideration of human factors in investigation reports and the launching of a new and anonymous reporting system.

ANSTO has a training group that supports the whole organisation. In addition to this, the Nuclear Medicine Business Unit, which Health Products is part of, has a small team dedicated to training specific for personnel whose work is associated with nuclear medicine. Training needs analysis is being conducted for every section, and is progressing in a timely manner, so training requirements are clear and documented. Compliance with training requirements is routinely monitored and has improved significantly. 

Security 

The inspection examined the effectiveness of Health Products’ security arrangements to prevent unauthorised access or damage to, or loss, theft or unauthorised transfer or unauthorised use of radioactive material within the Health Products facilities. The documentation provided, and discussions held with inspection participants, did not identify any significant issues with the security of their facilities, operations and management of radioactive sources. 

The endorsed Facility Security Plan (FSP) was reviewed in the last 12 months with appropriate internal approval sign off in July 2024. The security risks were assessed as part of the 2024 FSP review and was considered to adequately cover the security risks across the facilities. It was noted that the review element of the FSP stated the plan required review every 3 years in line with ANSTO Security Plans and Arrangements, however RPS 11 requires that category 1 – 3 radioactive sources have annual review of the security plan. As such, the FSP must be updated as a matter of priority to reflect this requirement and this constitutes an area for improvement. 

ANSTO has appropriate response mechanisms in place to counter or mitigate identified threats, minimising the impacts from potential serious security incidents. The Australian Federal Police (AFP) and ANSTO Site Operations Centre (ASOC) are the main conduit for communications of security incidents from the licence holder perspective where relevant response personnel can be deployed as necessary. When reviewing the GRC report, a range of incidents occurred over the past 2 years that are considered real time scenarios that tested both the ASOC and the AFP response to those incidents. Further, the AFP, ASOC and Building 23 conducted an interoperability training exercise within the last month where the outcomes highlighted several improvements that will be made. Although the interoperability training exercise was conducted in the last 12 months and there were several live scenarios over the last 2 years testing the response arrangements, Health Products did not have a planned schedule of annual response drills and exercises in accordance with the FSP. Health Products are requested to provide details of the schedule for annual response drill and exercise program to ARPANSA within 4 months. This is considered an area for improvement. 

The personnel security program across ANSTO and the controls specifically in place for Health Products are assessed as appropriate. All personnel security (vetting) is conducted internally via ANSTO Vetting Officers. However, where deemed necessary, the Australian Government Security Vetting Agency (AGSVA) is used for security clearances where a greater level of scrutiny is required, for example for staff who will be given access to national classified information or access to sensitive areas. 

The FSP details the expectations for staff accessing varying areas, from general access to those areas that have radioactive sources, including how access is managed to those areas. Further, the management of keys is considered appropriate. It was noted that the business had undertaken a significant review of access over the last 12-18 months, where staff access to areas not deemed necessary for work was removed. 

The security training and awareness program is delivered across all ANSTO businesses and in accordance with the ANSTO Security Plan, ANSTO Security Manual, and as part of the ANSTO Security Training and Awareness Strategy. Health Products staff have undertaken the relevant security training, which was evidenced via the detailed training spreadsheets and building induction tracker reviewed. 

The test and maintenance program across the ANSTO site comprehensively captures the test and maintenance requirements of all ARPANSA licence holders, including Health Products. Health Products forms part of the annual testing schedule across the varying elements of protective security including access control and intruder alarm systems, amongst others. The inspection team was advised that Health Products’ testing program was pushed back by one month to accommodate the timing of another licence holder, and this was considered acceptable to the ARPANSA Security Adviser. ANSTO Security meet weekly with contracted security providers, to discuss testing and maintenance schedules across the site, and meet weekly to discuss and resolve any issues encountered from both the client and service provider’s position from the past week. 

A detailed review of information security, cyber security, IT and operational technology (OT) systems was not conducted during the inspection, although future OT systems were discussed. The documentation reviewed prior to the inspection did not identify any issues with the controls in place for the security of information, when considering the ANSTO wide requirements contained within the ANSTO Security Plan and ANSTO Security Manual. Additionally, the inspection team were advised that ANSTO Cyber Security and IT/OT security personnel will conduct the appropriate assessments of the processes controlled by OT, when they come online. 

The security measures in Building 23 were physically inspected and found to meet the standards required for a Category 1 (source) facility as defined by RPS 11. 

The discussions throughout the inspection suggested that both safety and security are considered across the Nuclear Medicine business unit, leading to better business outcomes when considering the potential uplift of the security culture across the operations. 

Emergency preparedness and response 

ANSTO uses a cascading series of documents to outline the approach to managing any incidents or emergency situations. These documents are respectively focussed at the organisational, site and facility levels. ANSTO has adopted the Australasian Inter-Service Incident Management System (AIIMS) which is the nationally recognised system of incident management which is also used by emergency services and combat agencies. Amongst other things, this enables ANSTO to better cooperate and coordinate with external emergency services in the event of a major or critical incident.

In addition to the above, ANSTO is also aware of the role that prevention and preparedness play prior to an event occurring. This includes undertaking risk assessments, implementing safety systems, procuring equipment and resources and undertaking exercises and drills, amongst others. 

ANSTO’s emergency preparedness officers have been meeting with management of the various facilities, including Health Products. This has been to collate risk assessments to use when developing scenarios to test the preparedness levels of the facilities. A desktop exercise was recently undertaken for the facility. The hypothetical scenario involved a shielded container being dropped and the liquid radioactive material inside being splashed in the general area. The engagement with facility management, staff, and supporting functions within the organisation enabled the discussion of suitable response plans for the situation. The exercise had specified objectives that were being tested. Observations were recorded and actions were identified for improvement. Further work is planned to re-visit the hypothetical scenario two more times. This is part of a staged approach towards increasing the level to which the exercise challenges management, staff, and responders. 

Findings 

Health Products 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: 

1. Enhance the level of detail of visual inspection records to demonstrate the current state of ELWIS tanks. 
2. Consider the potential for skin contamination when determining the hazard categorisation of laboratories. 
3. Improve the timeframe for new workers completing training, and their supervision arrangements. 
4. Review the approach to investigation, to maximise the benefit associated with safety observations, near misses, incidents and accidents. 
5. The FSP be updated to reflect the annual review requirements applicable to the facility, in accordance with RPS 11. 
6. Create and submit a schedule for annual response drills and exercises applicable to the facility. 

It is expected that improvement actions will be taken in a timely manner.