Inspection report: ARPANSA Medical Radiation Services Branch (MRSB), Yallambie VIC, (R24/02504)

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 F0046.

The scope of the inspection included an assessment of ARPANSA MRSB’s performance against the Facility Performance Objectives and Criteria (POCs). The inspection consisted of a review of records, interviews, and physical inspection of the facility. 

An inspector from the Tasmanian radiation regulatory authority (Department of Health, Tasmania) participated in the inspection to provide independent oversight.

Background

ARPANSA MRSB (F0046) is authorised to operate linear accelerators (linac) and a teletherapy laboratory. MRSB currently routinely operates a single linac, which provides photon and electron beams. The teletherapy laboratory includes a Co-60 source and a Cs-137 source. The linacs and teletherapy laboratory are used to maintain primary standards and provide calibration services.

The main codes and standards applicable to this licence are those that appear in section 59 of the Regulations and:

• Australian/New Zealand Standard: Safety in laboratories Part 4: Ionizing radiations (AS/NZS 2243.4:2018)
• Health Physics Society (HPS) Installations using non-medical X-ray and sealed gamma-ray sources, energies up to 10 MeV (ANSI/HPS N43.3-2008).
• IAEA Safety Standards Series No. SSG-8: Radiation Safety of Gamma, Electron and X Ray Irradiation facilities

Observations

No non-compliances were identified. However, there were three Areas for Improvement (AFI) and these will be discussed within the body of the report.

Effective control

During the inspection, inspectors clarified who the Radiation Protection Advisors associated with MRSB were, as well as the composition of ARPANSA’s Radiation Safety Committee (RSC). Inspectors then queried the RSC’s responsibilities, as specified within ARPANSA’s Radiation Safety Management Manual (the Manual), which include: review and approval of changes related to radiation safety as well as procedures monitoring compliance with legislation; and review of staff doses and area radiation surveys. However, the inspection findings indicate that the RSC only reviews changes related to documentation with radiation safety relevance and monitors compliance through review of internal audits conducted by the Quality Manager separate from the RSC.

The Manual also states that the RSC develops and documents the radiation protection program for the licensed activities and reports on its implementation. This is not aligned with the review and approval duties of the RSC. The aforementioned responsibility sits with the licensed branches of ARPANSA and not the RSC.

ARPANSA’s documentation management framework requires that all documentation be reviewed regularly. All policies, frameworks and quality procedures are to be reviewed annually, standard operating procedures and supporting documents to undergo a review every two years, and appropriate records are to be kept. This framework does not capture the three-year review period for the Plans and Arrangement (P&As) as required by the legislation. Also, ARPANSA has initiated a new radiation safety policy which mandates an identical three-year review period for all documents with a radiation safety component. ARPANSA’s radiation safety officer indicated that work is being conducted to align the

system for documentation control with this mandated period. The licence holder’s representatives were unaware of what was stipulated in the document management framework, however, the P&As were within their legislated review period.

In accordance with the Manual, compliance evaluations are to be undertaken periodically against the relevant legislation, codes and standards, etc. The Manual specifies that areas and activities that present a higher radiation exposure risk shall be scheduled for more frequent audits. The same requirement applies to areas that are found to be non-compliant. However, no increase in audit frequency appears to have occurred as a result of MRSB’s previous instances of non-compliance.

The Manual also discusses key performance indicators and metrics as part of performance evaluation and indicates that these shall be developed by ARPANSA in consultation with MRSB as well as other branches of the Agency. At the time of the inspection, it was uncertain what these were.

These observations indicate shortfalls in processes and documentation control. They are considered to contribute to a singular AFI relating to documentation in support of radiation safety.

Safety management

Both the aforementioned radiation safety policy and Manual reference measurable objectives and targets in the context of the principles of radiation protection, continuous improvement, and meeting agency goals. At the time of the inspection, it was not clearly articulated by representatives of MRSB what the measurable objectives and targets were, other than ensuring compliance or being linked to ARPANSA’s remit of radiation safety.

ARPANSA implements a Hazard Identification Risk Assessment and Management (HIRAM) tool. An AFI from a 2022 ARPANSA Radiation Health Services inspection (R22/04726) stated the HIRAM had no documented potential doses and no consequence ranking for radiological impact in the risk categorisation matrix. This AFI was identified by an inspection of a different licence but it concerns the ARPANSA overarching documentation and therefore it also applies to MRSB. The ARPANSA inspectors observed that this AFI has not been reflected in the agency’s documentation. This finding indicates a missed opportunity to make continuous improvements. This contributes to the AFI regarding ARPANSA’s documentation for safety.

In recent months, ARPANSA has implemented a new change management system which seeks to document the process of a wide array of changes including those that have regulatory implications (i.e. section 63/64, etc.). Change management has repeatedly been identified as an AFI and was a contributing factor to a previous non-compliance. The new system, which the inspectors considered to be an improvement, could be further improved. It also allows for pre-authorised changes to take place which do not follow the change management framework nor is it fully understood what could constitute a pre-authorised change. In addition, the change management framework document which governs the whole process was not available for review at the time of the inspection, other than via an intranet page. The referenced document on the intranet that is linked to ARPANSA’s records management system points to a framework that is still in draft and unapproved. This contributes to the aforementioned AFI regarding ARPANSA’s documentation. The change process is still new, and its implementation will be reviewed for its effectiveness in due course.

Radiation protection

One aspect of a non-compliance identified in a 2019 inspection (R19/05335) was that the area radiation monitor for the teletherapy lab had not been calibrated since 2007. In accordance with AS/NZS 2243.4, because the area monitor provides a qualitative result rather than a quantitative one, as its purpose is to signal presence of radiation, the monitor should be calibrated every five years.

During the inspection, a calibration certificate for the monitor was provided as well as an instruction for calibration, both of which are produced by MRSB. Rather than a calibration, what is taking place is more representative of a functional test (i.e. the monitor alarms when it detects a certain level of radiation). The results of the calibration certificate provided shows a calibration factor (CF) of two or more, resulting in a reading of at least double the dose rate that the probe is experiencing (in practice, standard ranges of CF above unity from 0 to ±30% are accepted). The calibration of the area monitor is therefore considered to be an AFI.

The Code for Radiation Protection in Planned Exposure Situations (RPS C-1, Rev. 1) requires the responsible person to adopt an appropriate dose constraint as part of optimisation in accordance with paragraph 3.1.13. The Manual describes how no ARPANSA-wide constraint has been set as it is not expected that that staff will exceed the public dose limits of 1 mSv per year. In doing so, it appears that ARPANSA has set a dose constraint whilst the text reflects the opposite. In addition, action levels are referenced in ARPANSA’s documentation, but it could not be ascertained as to what they are. Considering these discrepancies, the arrangements were not found to fully meet the intention of the relevant code requirements.

The teletherapy lab has a procedure (CoCs Source Instructions) which details instructions to be followed by staff in an emergency where the sources have not retracted into their shielded states. The document details that it is feasible to enter the exposure room in such a situation based on the nature of the exposure though it is known that doses in the beam are of such a high magnitude that occupational exposure limits could be exceeded in a matter of seconds (Therapy Source Safety Precautions). The procedure provides options to place the sources back into their housing using push rods or pulling the source back from the actuator end (Cs-137 only). Therefore, the procedure implies that entering the room is acceptable rather than including a planned recovery step. In addition, no training has been undertaken for use of the push rods. In practice, MRSB highlight that this is not what is meant to occur. Such a scenario should be planned and the implications of carrying out such work should be considered. It is noted that such an emergency situation has not occurred.

These findings further compound the AFI surrounding documentation relating to radiation safety.

It was noted that doses for staff continue to be within the required limits, area surveys and fortnightly basement checks are being performed as required, and maintenance continues to be conducted as planned or when necessary.

Radioactive waste management

The facilities do not generate any radioactive waste through their operations. As such, this POC was not discussed further.

Ultimate disposal or transfer

As part of operations of both the teletherapy and LINAC facilities, no routine disposals or transfers take place.

It is planned that the current Co-60 source will be replaced due to its decaying activity and hence is no longer considered useful. It is expected that this replacement will occur sometime in the calendar year and is currently still in the planning stages. The company that will conduct the replacement works has been engaged previously by MRSB in 2010 and will also be tasked with disposing of the current source.

As the plan progresses, MRSB will submit applications for any relevant regulatory approvals under section 63 of the Regulations.

Security

As part of annual security awareness training, a presentation is given to staff required to work in the area of the facility. This presentation, however, does not contain enough information such that it could be labelled as security training. MRSB have indicated that this training package will be updated, in consultation with ARPANSA’s security expertise, prior to its next use.

The security plan (the Plan) for the teletherapy lab, given it pertains to security enhanced sources, has recently been revised. Internal discussions between ARPANSA’s security function and MRSB had occurred towards the end of the 2023 calendar year to improve the document as it was not considered to be completely fit-for-purpose and could be improved. This improvement did not occur prior to the latest revision but will occur within a 12-month revision period.

The previous 2021 inspection (R21/09554) identified an AFI relating to the separation of responsibility between the licence holder and the Agency Security Group’s (ASG) function within the site and their engagement with one another. Though the AFI was actioned and considered closed by the licence holder, it was apparent that the reliance on ASG to undertake the security functions may reduce the Nominee’s awareness, ownership and accountability for security. Therefore, following this observation during this inspection, the previous AFI will be reiterated as part of this report.

Emergency preparedness & response

The Manual references ARPANSA’s emergency response (ER) framework as their comprehensive ER procedures and provides a link within their records management system. At the time of inspection, this framework was not available for review either via the link or in its previous form as stated in the Manual.

ARPANSA does have a set of emergency procedures (ARPANSA Emergency Response Procedures - Yallambie) that relate to their premises which details requirements of those in EPR positions (wardens, first aiders, etc.) in various stages of emergency, how to evacuate, as well as how to respond to other situations (bomb threat, shelter in place, etc.). For the MRSB facilities, specifically the teletherapy lab, a set of procedures is included for how to evacuate in an emergency and the return once given the all- clear. These will be removed and separated from the Yallambie procedures, as is planned for other specific responses. This will allow staff to more easily find and follow the instructions rather than having to navigate through the larger, more comprehensive current document.

ARPANSA has conducted emergency exercises annually and these generally constitute emergency evacuations. Once completed, they are documented via a debrief, however these were observed to be inconsistent in the level of detail recorded. ARPANSA is looking to improve this process and implement a set standard for these debriefs. The procedures also set frequencies, for exercises and reviews, as regular, periodic, annual, or preferred. This terminology creates confusion, however ARPANSA is looking to make the set frequencies clearer. These observations support the AFI surrounding documentation relating to radiation safety.

Environmental protection

The facilities are kept within their own shielded enclosures with multiple safety layers and devices to prevent an exposure. It is considered that no specific environmental protection issues arise based on the nature of the facilities, i.e. one is electronically generated therefore without power there is no hazard, and the others are sealed sources housed within shielded, protective structures.

Findings

ARPANSA MRSB 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. Radiation safety related documentation should be a clear and accurate reflection of what takes place and should be controlled/managed adequately.
2. Calibration of the area radiation monitors.
3. The licence holder should be engaged with the security function of the agency rather than reliant on others to ensure requirements are met.

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