ARPANSA Medical Radiation Services (MRS)
|Location inspected||Yallambie, Victoria|
|Date of inspection||2-3 May 2023|
This inspection was conducted as part of ARPANSA’s source 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 source licence S0003.
The scope of the inspection included an assessment of performance at MRS against the Source Performance Objectives and Criteria (SPOC). The inspection consisted of a review of records, interviews, and a physical inspection of sources.
An independent observer from the Victorian Department of Health and Human Services participated in the inspection to provide additional independence.
MRS is licensed under Section 33 of the Act to deal with controlled material and controlled apparatus in various laboratories at the Yallambie premises.
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 C-2 Code for the Safety Transport of Radioactive Material (2019)
- RPS C-6 Code for Disposal of Radioactive Waste by the User (2018)
- RPS 11 Code of Practice for the Security of Radioactive Sources (2019) (RPS 11)
- AS/NZS 2243.4 Australian Standard Safety in Laboratories – Ionizing Radiations (2018) (AS/NZS 2243.4)
In general, the management of radiation safety at MRS in relation to controlled material and controlled apparatus was found to be satisfactory. There appeared, however, to be areas where there is room for improvement as identified in the report.
ARPANSA has in place overarching high-level documents that outline how ARPANSA maintains effective control over controlled apparatus and controlled material held under ARPANSA licenses MRS (S0003), Radiation Health Services (S0002) and prescribed radiation facilities operated by MRS (F0046):
- ARPANSA-POL-1428 ARPANSA Radiation Safety Policy – version 2 (RSP),
- ARPANSA-SOP-1429 Radiation Safety Strategy - version 1.2 (RSS),
- ARPANSA- POL-1132 Work Health & Safety Policy ARPANSA-POL-1132 (WHS Policy),
- ARPANSA-FRM-0007 WHS Framework – version 4.1 (WHS Framework), and
- ARPANSA-FRM-0006 Radiation Safety Management Manual – version 4.1 (RSMM).
The RSP outlines ARPANSA’s commitment to radiation safety compliance and compliance with the Act and Regulations.
The RSS outlines the radiation protection framework intended to ensure appropriate ionising radiation safety standards are applied.
The WHS Framework establishes how ARPANSA maintains effective management of work health and safety throughout ARPANSA. The WHS Policy is reproduced within the WHS Framework (section 5.2).
The RSMM defines and documents ARPANSA’s approach to radiation safety including alignment with the WHS Policy, ARPANSA-POL-0981 Protective Security Policy and the requirements of the Act. The RSMM defines the procedures to be used by staff when carrying out radiation work and defines their roles and responsibilities for radiation safety.
Accountabilities and responsibilities
The RSP section 4 Roles and responsibilities, identifies the roles and assigned responsibilities to ensure compliance with the RSP and its periodic review. It assigns the roles and responsibilities into two classified groups - radiation safety specific roles and roles with specific radiation safety responsibilities.
The WHS Framework subsections 5.1 – 5.1.6, detail leadership and worker participation and the commitment and expectations required of all personnel to develop, implement and continuously improve work health and safety.
The RSP outlines the licence holder’s commitment to radiation safety compliance and compliance with the Act and Regulations. The RSP and RSS are supported by the RSMM.
However, RSMM subsection 9.3 Management Review specifies that:
‘At planned intervals, the ARPANSA senior management team shall perform a full review of all aspects of the Radiation Safety Management Manual to determine whether the Manual is suitable to fulfil ARPANSA’s radiation safety management requirements, whether the procedures and processes that make up the systems are adequate to manage ARPANSA’s radiation risks, and whether the implemented system is in fact effective in managing radiation safety risks to an acceptable level (ARPANSA-SOP-0925)’
ARPANSA-SOP-0925 subsection 4.1 Management review meeting specifies that the management review meeting is conducted twice per year. This review frequency was confirmed by the licence holder’s representatives. The most recent full senior management review was completed in March 2021, which was outside the specified review frequency. This was identified as an area for improvement.
Statutory and regulatory compliance
The licence holder’s quarterly reports have been submitted to ARPANSA Regulatory Services in a timely manner and contained relevant information on the licence holder’s compliance activities.
The RSMM subsection 8.1.3 Compliance evaluation, outlines a system of periodic evaluation of compliance with legal obligations, and applicable codes of practice and standards. It was observed that audits are conducted under an Internal Audit Plan 2022-2025 down to the level of standard operating procedure. The reports are provided to auditees, responsible persons, the ARPANSA Audit and Risk Committee and the ARPANSA Executive Group.
An example was sighted, ARPANSA Internal Audit report ARPANSA-FORM-0272 Primary Standards Dosimetry Laboratory, which detailed non-conformances and planned corrective actions.
MRS’ safety management is underpinned by the RSMM and the WHS Framework.
Safety policy and objectives
The RSMM subsection 6.1.1, outlines the licence holder’s commitment to achieving radiation safety objectives and in subsection 6.1.2 the commitment to upholding the principles of radiation protection and safety.
The RSMM subsections 6.1.3 - 6.1.7 cover more specifically ionising radiation, non-ionising radiation, classification of exposure groups, limiting exposure and dose constraints and action levels.
Monitoring and measurement
The RSMM subsection 7.5.3 Records of area surveys, outlines the requirements for periodic radiation monitoring of work areas and refers to ARPANSA-SOP-1437 Area Monitoring for Ionising Radiation on how area monitoring is undertaken. It was observed that area monitoring and surveys are performed as appropriate, and a specific example was highlighted during the inspection - X-ray Labs Survey Form IRC-FORM-8010C.
ARPANSA-SOP-1435 subsection 8 Management of Radiation Sources, specifies that all ionising radiation sources or their housing shall be examined for contamination and for integrity by an annual wipe test. Thirty-seven sources are wipe tested annually. A copy of Wipe Analysis Report EA23-21 (28 April 2023) was highlighted during the inspection as a specific example.
The RSMM subsection 10.1 Incident, nonconformity and corrective action, states that the licence holder maintains an intranet-based system of identifying, investigating, reporting and managing safety incidents. To demonstrate the process, the inspectors were taken through each step of the incident reporting process.
Radiation measuring instruments are calibrated in accordance with ARPANSA-SOP-1437 subsection 4.2 Calibration certificates, which specifies the calibration frequency for instruments used for quantitative measurements (annually) and for instruments used for qualitative measurements (5-year intervals). Instrument calibration is managed by Radiation Health Services.
Training and education
The RSMM subsection 7.2 Radiation safety induction and refresher training, details the radiation safety induction and refresher training requirements. Training records were found to be up-to-date.
Retraining frequency requirements are specified in ARPANSA-SOP-1431 subsection 4.4. An example was provided, using form ARPANSA-FORM-1470 Record of ARPANSA Radiation Worker Authorisation, which demonstrated how compliance with the RSMM is maintained.
Information provided during the inspection indicates that MRS personnel have received appropriate radiation safety training.
Radiation safety committees
The RSMM specifies that the Radiation Safety Committee (RSC) meets at least 4 times per year and is chaired by the ARPANSA Radiation Safety Officer (RSO) and attended by the Deputy RSO, and Radiation Protection Advisers. An example quarterly RSC meeting minutes was viewed and the inspectors were satisfied that the RSC meeting had been executed appropriately.
Planning and design of the workplace
The following observations were made during a walk-through inspection of MRS laboratories and storage rooms.
Room 327A (unsealed source laboratory)
AS/NZS 2243.4 Table 3.4 Column 1 - Write-up, specifies that a ‘small area of bench space specifically for documentation, etc. To be kept free of contamination’. Room 327A, which is used by MRS personnel for radiation work was found to have no such bench space available. This was identified as an area for improvement.
The following observations were made during the inspection and are noted for consideration by the licence holder:
- There was no signage at the barrier and contamination checking station to provide instructions on how personal contamination checks should be conducted and the appropriate handling of personal protective equipment. Although AS/NZS 2243.4 is silent on this matter, MRS should consider providing signage to prompt personnel to appropriate personal contamination checking and radiation hygiene procedures.
- A secondary exit door to the laboratory is provided for the purpose of facilitating the movement of heavy equipment into and out of the laboratory and also provides an alternative exit in the case of an emergency. However, personnel are able to exit freely via the door. There are no contamination monitoring equipment or decontamination facilities stationed at the exit as required by AS/NZS 2243.4 subsection 4.8.6. However, AS/NZS 2243.4 is silent on unsealed source laboratory emergency exit door requirements, it would be prudent for MRS to consider clearly sign-posting the door to convey that it is for the dual purpose of movement of heavy equipment into and out of the laboratory and emergency exit use only.
A source container housing a source listed in MRS source inventory workbook as LAD number 5510 Am-241/Be 370 GBq, was found to be insufficiently labelled when compared to AS/NZS 2243.4 subsection 5.1(e). This was identified as an area for improvement.
Room 120 (X-ray exposure room)
The red flashing light designed to alert persons within the X-ray exposure room of the presence of radiation was found to be not in working order. This was identified as an area for improvement.
Local rules and procedures
Information provided and observations made during the inspection indicate that MRS has in place a comprehensive suite of local rules and procedures to protect the safety of workers and other persons.
However, the following area for improvement was identified:
The RSMM subsection 7.2 advises that copies of rules and procedures, along with information on their application, is available to all relevant staff on the intranet.
During the walk-through inspection it was evident that the instruction had been implemented in all MRS radiation work areas. However, AS/NZS 2243.4 subsection 4.8.5(b) specifies that work procedures shall be prominently displayed within the laboratory where unsealed radioactive materials are used. When the matter of difference between the advice in the RSSM and the requirement of AS/NZS 2243.4 was raised during the inspection exit meeting, the inspectors were advised that a policy had been implemented to minimise paper documents in radiation work areas and the workplace in general.
MRS should assess the benefits of the policy against the benefits of having local instructions immediately available to personnel during the moment of use of unsealed sources in laboratories. Further, if laptops are used in unsealed source laboratories to access rules and procedures the laptops would be at risk of becoming contaminated.
Monitoring of individuals
The personal radiation dose monitoring and dose record keeping requirements for each monitored staff are specified in the RSMM subsection 7.5.2 Personal dosimetry records, subsection 7.5.6 Retention of records and subsection 8.1.1 Monitoring occupational radiation exposure and health surveillance. Personal radiation monitoring is managed in a satisfactory manner and dose records maintained as required by the RSO.
Management of radioactive waste
The storage requirements for radioactive sources are specified in the RSMM subsection 8.4.3 Storage in workplace, and the requirements for the storage of radioactive waste are specified in the RSMM subsection 8.5 Storage and disposal of radioactive waste and controlled apparatus and ARPANSA-SOP-1442 Radioactive Waste Management.
All storage areas inspected were found to be in accordance with relevant ARPANSA requirements and the storage requirements of AS/NZS 2243.4.
All radiation sources in storage were found to be accurately recorded in the MRS source inventory workbook.
The sealed radiation sources held by MRS are adequately covered by appropriate sealed source security arrangements as per the requirements of RSP 11.
Emergency plans and procedures
It was noted that the licence holder has comprehensive emergency response procedures in place, ARPANSA-SOP-1468 ARPANSA Emergency response Procedures – Yallambie, which have been developed to meet the requirements of Australian Standard AS3745-2010 Planning emergencies in facilities (AS3745-2010). This inspection did not include an assessment of the adequacy of ARPANSA’s emergency plans and procedures or compliance against AS3745-210.
Protection of the environment
Protection of wildlife
The RSMM subsection 7.5.4 Records of environmental discharges, covers the controlled releases of radioactive material to the environment. While any release to waters would be covered by a trade waste agreement with the local water authority, the licence holder is not involved in such releases.
There was no evident or likely environmental exposure situation associated with the use or storage of radiation sources by the licence holder.
The licence holder was found to comply with the requirements of the Act, the Regulations, and licence conditions.
The inspection revealed the following areas for improvement:
- ARPANSA senior management reviews of all aspects of the Radiation Safety Management Manual had not been carried out within the required frequency.
- Room 327A had no bench space available to be kept free of contamination for activities such as write-up of documentation.
- Labelling of source LAD 5510 - insufficiently labelled when compared to AS/NZS 2243.4.
- Defective warning light fitted to an X-ray exposure room.
- Assessment of the benefits of the MRS policy to minimise paper documents against the benefits of having local instructions prominently displayed in unsealed source laboratories.
It is expected that improvement actions will be taken in a timely manner.