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Inspection report: ANSTO Nuclear Medicine (ANM), Lucas Heights, (R21/10854)

Inspection report details
Licence holder: ANSTO Nuclear Medicine (ANM)
Location inspected: Lucas Heights
Licence number:  F0309
Date of inspection: 30 September 2021
Report number: R21/10854

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 F0309. 

The scope of the inspection included an assessment of ANSTO’s performance at the ANSTO Nuclear Medicine (ANM) facility against the Performance Objectives and Criteria (POC) for security and emergency preparedness and response. The inspection consisted of a review of records, interviews, and due to further outbreaks of COVID-19 was conducted via virtual means.

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 80% of all nuclear medicine procedures. This facility was designed to replace the previous Building 54 facility licensed under ANSTO’s Health Products F0262 licence. The Mo-99 is extracted from low enriched uranium targets, processed, packaged and despatched to ANSTO’s Health Products facility for use in Technetium-99m Generators as well as for overseas radiopharmaceutical facilities.

Observations

An area for improvement (AFI) focussing on the Plans and Arrangements (P&A) has been identified in relation to the ANM facility.
During a desktop review of information supplied prior to the inspection, it was noted that four of the Plans and Arrangements (P&A) had gone outside the required period for review (and update where necessary). This is considered to be an AFI given that ANSTO demonstrated evidence of their review, which occurred within a couple of months after that period, and relayed that changes were mainly editorial in nature and without safety significance. These editorial changes will be relayed to ARPANSA in the near future as part of the quarterly report under section 64 of the regulations. 

ANSTO also informed ARPANSA inspectors that a section 63 submission would be made in March 2022 which would include the P&As in a rewritten format. 
It is worth noting that several topics of discussion with respect to the POCs for this inspection were impacted by findings of previous inspections and it was clear that the licence holder is continuing to address these in order to improve.

Security

The ANM facility, in terms of access, is no different to any other ANSTO facility as they all fall under the same principle, the “need-to-access”. Only those staff with a legitimate need to be within the facility are authorised to have access which can only be granted once security clearances and approvals have been completed (both by ANSTO and AGSVA). Access has been recently reviewed for the facility given the new arrangements in place due to COVID-19.

In addition to the measures that secure the rest of the site (with respect to physical, information, ICT and personnel security) as described in ANSTO’s Security Plan (AG-5534) and the ANSTO Security Manual (AG-1028), ANM has also defined specific zones within the premises for which access is given dependent on a staff member’s role as well as limiting access to nuclear material specific to its conduct.

Inspectors also queried how ANM learns from other facilities at ANSTO. ANSTO informed inspectors that there is a close relationship with ANSTO Health products as they fall under the same umbrella of Nuclear Medicine but also that virtual channels have been opened between all the licensing officers at the site in order to directly feed information to each other for awareness. This would include, among other things, the results of ARPANSA inspections. This use of information sharing, not previously allowed by other platforms, would allow all facilities to directly draw from lessons learnt and experiences from identified issues and apply them to their situation if applicable.

In terms of security training at ANM, it is evident that security awareness filters across the site through mandatory insider threat and security breaches modules which are undertaken periodically. It should be noted that a recent inspection of ANSTO Health Products (R21/08370) identified an AFI around the capture of the mandatory annual security awareness training as per AG-1028. This issue is relevant at ANM but also more broadly to ANSTO as a whole. As per that same inspection report, and reiterated during this inspection, ANSTO has performed a review of their security training package and developed new modules and plan for its implementation. This has been coordinated between the security and learning and development teams. In addition to this, ANM has its own training team who will determine the needs of the facility and tailor their training accordingly.

As part of their requirements, ANM personnel were able to demonstrate that they had tested the response of their guard force and that all nuclear material had been accounted for at a point in time. In relation to their guard force, ANSTO considers that though the response was satisfactory, further ANM familiarity training would need to be given to newer staff as teams with greater knowledge performed better than those without.

Emergency preparedness & response

ANSTO has recently employed a new emergency response contractor, Opstar, who has been present on-site for approximately 6 weeks. ANSTO considers this new arrangement to be an improvement to their previous system given the demonstrated capabilities of the provider, especially in relation to first aid and medical response, are deemed to be greater than those of the previous provider. Despite having the new provider, ANSTO has retained the majority of their previous emergency response staff and therefore retained valuable knowledge which can be utilised to bring new staff up to speed.

ANSTO has also created new guidance material for exposures in emergency situations. This new training material describes dose values within which personnel can be exposed to if they are put into a situation where they must take life-saving action and rescue someone. This training is being rolled out to all personnel on-site but is being impacted by its method of delivery (virtual – as solely online was deemed not adequate and face-to-face is impacted by COVID) currently limited to 4 sessions per month with varying attendance (15 to 40 people). To date, half of the staff at ANM have completed this training.

Staff at ANM are also trained in emergency response as part of their standard inductions as well as the operator accreditation process which allows them to understand the operational parameters at the facility and their tolerances where anything outside this requires investigation.

At the time of the inspection an audit was being performed on equipment used by the emergency response teams to look at what they had and whether it is at the current industry standard. Opstar has their own procedures which dictate certain equipment because they have been tested in practice and considered reliable.

As with the security documentation, emergency response documentation is also under review. This has been previously discussed in the recent ANSTO Health Products and Waste Operations (R21/06344) inspections. Currently there are some discrepancies between site-wide emergency co-ordination activities, which rely on the AIIMS complexity-based incident classification (level 1, 2 and 3), and local radiological emergency requirements which are based on the area of effect (I.e. alert, facility, site, general). Documentation is being developed to harmonise the incident and emergency response across ANSTO. This should enhance the clarity of roles, communication, escalation, and notification procedures. 

Emergency exercises at the facility are required periodically but have not been performed since late-2018. In July 2021, ANM had planned to undertake an exercise at the facility which would see the testing of their emergency response capabilities in the event of a power outage. Recent COVID lockdowns in Sydney meant that the planned exercise could not go ahead. Instead, the scenario was performed as an “activity” with the staff that were available at the time. The after-action review identified lessons, which are expected to be implemented. ANSTO informed inspectors that some form of exercise will go ahead in the near future when restrictions are eased. Separate to this, every building on-site is drilled annually for their response to fire-alarms and subsequent evacuation.

Findings

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 area for improvement:

  1. Ensuring that reviews (and updates where necessary) of the Plans and Arrangements are performed in a timely manner.

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