|Licence holder||ANSTO Nuclear Medicine (ANM)|
|Location inspected||Lucas Heights|
|Date of inspection||14/06/2022|
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 ANM against the Performance Objectives and Criteria (POC) for event protection and radiological protection. The inspection consisted of a review of records, interviews, and physical inspection of the facility.
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. 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.
The previous inspection of ANM (R21/10854) identified an area for improvement (AFI) to ensure that reviews (and updates where necessary) of the Plans and Arrangements are performed in a timely manner. Inspectors were supplied with ANSTO’s AF-3417 form (Reviewing Plans and Arrangements for ARPANSA licences) which demonstrated that the review had taken place prior to this inspection and that new revisions should be implemented within a defined period but no changes related to safety. As such, inspectors consider the AFI to have been addressed.
As a result of this inspection, one AFI has been identified along with one good practice. These will be highlighted further within the report.
The ANM facility has been demonstrated to be safe in the event of an external natural or human induced event as part of its licencing basis. The majority of these events have been assessed in the safety analysis to be not credible with the remaining events considered in the design.
Several of the most likely events (bushfire, localised flooding, and loss of power) were discussed in relation to the facilities ability to withstand them. ANSTO conducts pre-season checks as part of bushfire prevention activities as part of greater site-wide arrangements. This is documented in ANSTO’s AF-2534 Bushfire Pre-Season Building Checks and Preparation form that was supplied to inspectors. No issues were identified.
Given the extensive torrential rain experienced in the earlier months of the year, inspectors queried what impact this had on the facility. Though issues with storm water were a concern for the site in general, the facility itself experienced no negative impacts as a result of the heavy rainfall.
A loss of power incident was also discussed. However, if the facility were to lose power, there are multiple means of restoration in place. A project is currently being undertaken to increase capacity of one of the back-up systems and additionally eliminate the need for operators to physically manipulate and connect the system to restore power.
No issues were identified in relation to Event Protection.
ANM is in the process of implementing a training package for its operators in relation to tasks associated with front of cell. The activities being addressed are associated with the packaging cell from which customer orders and QC samples of Mo-99 are removed, surveyed, and cleared. The training of the operators is being observed by the Health Physics Surveyors to ensure that staff are demonstrating the requisite attention to radiological safety.
Incorporated at the packaging cell, located in the front-of-cell, are a new series of informative signs relaying radiological safety information. These signs address contamination monitoring for skin, PPE and equipment/items/work surfaces specific to the area in question. The same system of signage is employed in the rear-of-cell however, given that the nature of the hazard is more significant within that area, the level of detail has been increased to ensure that it is commensurate with the hazard. The signs were developed by the facility in conjunction with Radiation Protection Services, High Reliability and Communications teams to ensure that the information included was appropriate and that the signs would be effective from a human factors perspective. This is demonstrated through: the inclusion of calculated contamination values that have been separated into action levels of increasing severity; the response employed on determination of the appropriate action level is differentiated (inclusive of surveying, restricting access, decontamination, scene preservation, etc.); each tier of response culminates in raising a report within ANSTO’s Governance, Risk and Compliance (GRC) system to ensure incidents are tracked and trended; the contamination level observed is related to the potential dose received within the bounds of the action level system using a colour classification scheme, and simplicity of design and readability.
The signage has also been incorporated into ANSTO’s Radiological Monitoring at ANM procedure which is required to be read by all staff as part of the licence holder’s training requirements. Given the above, ARPANSA inspectors consider this administrative control to fit the definition of a good practice.
Since the ANSTO Health incident in 2017, risk information has been incorporated into procedures to ensure staff are aware of the potential radiological doses associated with the tasks being performed. Inspectors reviewed two recently revised procedures, ‘Radiological Monitoring in ANM’ and ‘PADIRAC Operations’, noting that the risk information was not entirely accurate. Though the risks are documented as being those represented within the facility’s operational risk assessment, the activities for which the procedures have been developed have larger radiological consequences and risks than are presented. This represents an AFI as the appropriate information should be communicated within procedures for the activities being undertaken.
Inspectors enquired about the use of radiation attenuating gloves at the facility following recommendations made as a result of the licence holder’s own assessments. They are currently being utilised by QC staff as the initial PPE layer followed by a secondary nitrile glove to reduce any potential skin/extremity dose that may occur in a contamination scenario. A technical report was developed that discussed not just the attenuative properties but the issue of glove practicality (operator dexterity, etc.) and as such a recommendation was made to update the report following further studies. To date, this has only been performed informally. However, the glove manufacturer is changing the material of construction. Tests are currently being performed by the licence holder to provide assurance that the radiological safety properties, for which they were chosen, have not been degraded by this change. Inspectors consider that, upon completion of the radiological testing of the new gloves, the issue of glove practicality should be investigated and demonstrated in-line with the licence holder’s original recommendation.
Inspectors also undertook a review of radiological assurance surveys performed and calibration of radiation protection equipment. No issues were identified.
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:
- Ensure that the appropriate risk information is communicated in procedures
The inspection revealed the following good practice/s:
- Implementation of an administrative control (signage) with consideration of human factors that readily communicates the potential radiological impacts associated with tasks being performed specific to the area of work and the process involved to control or remediate the situation.
It is expected that improvement actions will be taken in a timely manner.