Inspection report: ANSTO Health Products, Lucas Heights, NSW, R22/03042

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 F0262. 

The scope of the inspection included an assessment of ANSTO’s performance against the following Performance Objectives and Criteria (POC): Performance Reporting Verification; Inspection, Testing and Maintenance; and Configuration Management. The inspection consisted of staff interviews and a review of procedures, events, maintenance activities and actions as identified in the ‘Implementation Plan’ developed in response to the Independent Review of ANSTO Health Products (2018) (hereafter referred to as ‘the Review’). 

Background

ANSTO’s Health Products facility is part of the greater Nuclear Medicine division at ANSTO (which also includes ANM) and forms part of ANSTO Nuclear Operations and Nuclear Medicine (OPAL, Nuclear Medicine and Waste Management Services). 

It is a radiopharmaceutical production facility that primarily produces molybdenum-99/technetium-99m generators along with various other radioisotope products use for the treatment and/or diagnosis of disease including cancer. 

Observations

The licence holder was found to be compliant with the Act, the Regulations, and licence conditions. Within the bounds of the POC, inspectors took a broad approach to understand how the licence holder was conducting its activities while making efforts to continuously improve. This includes implementing recommendations from internal and external sources. 

Performance reporting verification

The last scheduled inspection which covered the same POC occurred in 2019 (R19/08620). ARPANSA inspectors examined how the areas for improvement (AFI) from that inspection had been addressed. These focussed on ensuring investigations occurred in line with procedure, the sharing of lessons learnt with other ANSTO licence holders, and management of temporary changes. All AFI had been captured in ANSTO’s incident management system (GRC), actioned, and tracked to closure. No issues were identified.
 

ANSTO Health Products reports quarterly as required by licence condition 3 of F0262. A more comprehensive report is also supplied which provides a breakdown of the facility’s safety performance over the reporting period and a summary of incidents that have occurred in that time. Inspectors reviewed these reports for the 2021 calendar year, focussing on a detailed examination of incidents that fall within the scope of the inspection. While no radiological safety consequence was realised, inspectors focussed on the root cause investigations of these events and what learnings had been implemented along with post verification of key actions taken. From a maintenance perspective, licence holder representatives were able to demonstrate that failures were systematically analysed and fed into actions leading to an improved system whether it be updating strategies based on operational experience, improving communication with contractors or requesting capital projects to replace equipment.

Tied in with incident investigation, inspectors discussed recommendation 41 of the Review which refers to implementing a positive investigation methodology process to celebrate ‘when things go right ‘as opposed to solely focussing on ‘what went wrong’. Though still relatively new within the investigation process, examples were shown for where actions from this feedback had been made to the system for maintenance to ensure that performance is continuously improved.

Recommendation 16A/B of the Review focuses on identifying, understanding, and strengthening safety culture. This is performed through a review of ‘Big Data’ and ‘Deep Data’ as described in the Methodology for Developing and Review of Culture at ANSTO. Though a review at ANSTO Health Products had been performed in 2018, a second review has not yet been conducted from which comparison could be drawn between consecutive results. An online dashboard was presented to inspectors showed routine ‘pulse’ surveys on staff engagement. This dashboard allows the user to filter the performance by providing the option to select multiple areas (Health Products, ANM, Waste Operations, etc.) as well as subsets (QC, production, etc.). ARPANSA will continue to monitor the implementation of this recommendation. 

Configuration management

Change is a regular occurrence at the facility. In following their ‘Management of Change’ process, circumstances can dictate that nuclear/radiological safety and regulatory determinations must be made if changes require approval by ARPANSA prior to implementation. Determinations which do not require prior approval but are nonetheless required to be reported are provided in quarterly reports. A number of examples were reviewed by ARPANSA inspectors. No issues were identified.

The Review listed a large number of recommendations and areas for improvement. A selection of these were discussed during the inspection as to how they affect the facility and what has been done to address them; two of which were discussed in more detail.

Recommendation 72 centres on making the risk reduction process more robust. Part of this relates to the assessment of critical controls in determining their effectiveness and what actions are required if deemed ‘ineffective’ or ‘partially effective’. Given the use of the critical control concept is quite new in the radiological safety sphere at ANSTO, as is the assessment of those controls, no examples of control effectiveness were noted to date. ARPANSA inspectors will continue to monitor implementation of this recommendation through the inspection program and assessment of incoming submissions.

While discussing recommendation 74 (incorporating human factors into the risk assessment process), inspectors discussed a change made in August 2018 which saw an engineered control (a collar and strap) added for the generator production process that would more adequately secure the shielded lid to the device in case of a drop thus preventing exposure of the radioactive contents inside. The need for the addition of this control was determined during ANSTO’s risk assessment process though the risk is still considered to be high. ANSTO recognises that this control is only a short-to-medium term solution and that a stronger medium/long solution should be considered. 

An incident (GRC 11821) as described in the most recent quarterly report led to the drop of a generator pot as described in ANSTO’s generator risk assessment. The investigation of this incident was being finalised at the time of the inspection. Inspectors requested a copy of the concise investigation report when finalised as well as any additional documentation supporting the change and will continue to monitor the situation as well as the proposed upgrade.

The most recent addition to the Health Products portfolio is the production of rhenium-188 (Re188). In August 2021, ARPANSA allowed full production, but included a request for additional information to be supplied when radioactivity had increased to certain levels. However, production has been sporadic, due to demand, and therefore production has only recently reached that level. In addition, ANSTO is potentially considering a reduction in the maximum level of radioactivity they require which could lead to a revision of their risk assessment. As such, ARPANSA will await the results of the aforementioned request and any changes to the assessment for Re188 production if required.

Inspection, Testing and Maintenance

Maintenance conducted at ANSTO Health Products is performed by a number of service providers. This includes a facility specific team, a group external to the facility (ANSTO Maintenance and Engineering or AME – previously known as Engineering and Capital Projects) and contractors. Since the Health Products’ portfolio extends across the Lucas Heights site, oversight of maintenance activities for each area has its own responsible person.

Maintenance data for all areas (B23, B54 and B76) for the 2021 calendar year was exported from ANSTO’s computerised maintenance management system and supplied to inspectors. It was noted that a significant proportion of the incomplete maintenance works related to quality tasks (for example, calibrations of quality control equipment) as opposed to facility plant and equipment. This is confirmed by the ANSTO Health Product’s asset manager as part of monthly reporting of ‘open’ tasks. ANSTO’s maintenance activities are also tracked in real-time using Microsoft’s Power BI which allows those responsible to track work orders across the organisation’s numerous planner groups (i.e. building maintenance, fire systems, electrical, etc.) The backlog was part of the response to the Covid-19 pandemic where tasks were prioritised based on safety. 

The system for maintenance was also discussed. Maintenance plans/strategies that underpin the current status of the facility are being continually developed. While initially based on vendor manuals, a far more useful metric as considered by the facility is operational experience and optimising the system based on reliability centred maintenance (RCM) principles which are aimed at preserving plant/equipment functions, identifying and prioritising failure modes that affect those functions, and subsequently controlling them. Strategies are currently being developed by systems engineers focussing on areas of high priority (Lu-177, I-131, etc) as part of the Asset Management Action plan.

A maintenance shutdown scheduled for April 2021 was postponed until September due to an unplanned OPAL shutdown in mid-March. Health Products performed an impact assessment of the situation and determined that it was likely that supply of nuclear medicine would be disrupted if the scheduled maintenance activities occurred in B23 as planned. The licence holder considered the delay to be an acceptable risk. The works scheduled/performed related to reliability of the facility and other compliance matters (e.g. TGA commitments) rather than radiological safety.

A positive action from lessons learnt in other facilities was implemented by Health Products during the September 2021 shutdown. In certain periods of 2021, Covid-19 placed heavy restrictions on personnel. Health Products instituted its own online shutdown maintenance channel to allow for rapid communication between staff working remotely and those onsite. This was implemented following a similar experience at ANSTO’s ANM facility during a smaller shutdown.

Inspectors reviewed if operating limits and conditions (OLCs) for B54 were complied with, and all associated surveillance and maintenance was carried out. A recent report by ANSTO reviewed these surveillance requirements, after the facility was in a non-operating or ‘passive’ state. No issues were identified.

Findings

The licence holder was found to be in compliance with the requirements of the Act, the Regulations, and licence conditions.