Inspection report: Department of Infrastructure, Transport, Cities and Regional Development, NIHRACS (R21/05693)

This 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 1999 (the Regulations), and conditions of the Source Licence S0324. 

The scope of the inspection included an assessment of Department of Infrastructure, Transport, Cities and Regional Development’s (the Department) performance at the NIHRACS site against the Source Performance Objectives and Criteria (PO&Cs). The inspection consisted of a review of records, interviews, and physical inspection of sources.  

Background

NIHRACS is authorised under section 33 of the Act to deal with portable and fixed general medical X-ray, dental X-ray apparatus as well as mammographic and orthopantomogram (OPG) dental X-ray units.

The controlled apparatus are utilised in support of medical services (Hospital, Aged and Dental Care) for the community of Norfolk Island.

Source Licence S0324 is issued to the Department with the Department’s Secretary being the licence nominee. Management of the licence, oversight and direct support for NIHRACS falls within the Territories Division of the Department in Canberra.

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

1. Radiation Protection Series C-5: Code for Radiation Protection in Medical Exposure (2019) 
2. Radiation Protection Series 10: Code of Practice and Safety Guide – Radiation Protection in Dentistry (2005)
3. AS/NZS 2243.4 Safety in laboratories Part 4: Ionizing radiations (2018) 

Observations

In general, the operation of the controlled apparatus at the NIHRACS radiology and dental suites were found to be satisfactory; however, disposal of a controlled apparatus had been effected without the approval of the CEO of ARPANSA in accordance with section 65 of the Regulations. Furthermore, several administrative discrepancies were found relating to controlled apparatus and their noted serial numbers in the NIHRACS Source Inventory Workbook (SIW). Documentation issues were also identified during the inspection within the plans and arrangements for managing safety – the NIHRACS Radiation Safety Plan (2019) (RSP). Rectification of these issues will aid in strengthening the RSP as well as administrative and physical safety practices.

Effective control

Accountabilities and responsibilities 

Day to day management of the NIHRACS facility on Norfolk Island is undertaken by NIHRACS staff including the NIHRACS Manager and the senior radiographer who is also the nominated Radiation Safety Officer (RSO). NSW Health through the South East Sydney Local Health District (SESLHD) is currently contracted to provide support and advice to NIHRACS for any operational, technical or clinical matters when required.  

The RSP was produced by the SESLHD and is generic in type with the objective to provide guidance to NIHRACS in formulating a plan more specific to NIHRACS operations. 

Roles and responsibilities are outlined in the RSP.  Aspects of the RSP did not, however, accurately reflect many current NIHRACS radiology practices. Attention is required to improve the quality of the document so that it reflects current codes, standards and NIHRACS operational practices.

Management commitment

Some administrative issues and processes still require refinement within the RSP. In particular the roles and duties of the RSO in liaison and reporting between NIHRACS management, the Department officers in the Territories Division and ARPANSA, noting the Department is responsible for the licence and the RSO for reporting and management of controlled apparatus approved under the licence. 

The NIHRACS Manager and RSO had commenced and or completed corrective actions on some minor AFIs identified during this inspection by the time of the exit meeting. However, some AFIs identified in the 2019 inspection under previous corrective action plan had not been addressed correctly and were again identified in this inspection such as record keeping, incorrect serial numbers and ensuring an appropriate disposal pathway for the OPG in accordance with section 65 of the regulations. 

Documentation and document control

Discrepancies were identified between the serial numbers of some controlled apparatus and their listing in the SIW for NIHRACS contrary to section 62 of the regulations. This included an incorrect serial number for the surgery room 1 dental X-ray unit.

A new X-ray unit had been installed in surgery room 1 with the unit’s compliance documentation showing it was installed in early 2020. This unit’s serial number did not correspond with that recorded in the NIHRACS SIW. It should be noted that if this X-ray replaced a previous unit, there is no evidence on ARPANSA files or with NIHRACS of a section 65 request to dispose of the old unit or transfer it back to the manufacturer.

The serial number for the dental X-ray unit in surgery room 2 corresponded to the compliance and test documentation affixed to the wall but did not correspond to that within the NIHRACS SIW. 

Further serial number discrepancies were also noted with both the OPG unit and the fixed X-ray unit in the radiography suite. The OPG unit’s serial number did not correspond with that recorded in the SIW.  

Serial numbers on the compliance plates affixed to the Fuji fixed X-ray unit did not correspond with those listed in the SIW. The NIHRACS Radiographer-RSO advised that the serial number provided by Fuji and noted in Fuji documentation was that listed in the SIW. The NIHRACS Radiographer-RSO will raise this issue with Fuji and clarify the serial number and location of where this is affixed on the unit and advise ARPANSA accordingly.

The current RSP states that review of the document will occur annually and was due 13 May 2021. There was no evidence that such a review had occurred. The inspection team advised the NIHRACS Manager and RSO of the legislative requirement for review (3 years) highlighting areas that will need addressing for the next version of the plan to better reflect the actual operations of both the radiology and dental departments within NIHRACS. Several codes and standards referenced in the RSP have been superseded and therefore require updating. 

Safety management

Training and education

A second radiographer has recently been employed by NIHRACS. This is expected to alleviate the issue of continuous on call arrangements undertaken by the current radiographer-RSO as identified in the 2019 inspection. The second radiographer’s training and qualifications were sighted during the inspection as well as certification records for the primary radiographer-RSO. 

The current NIHRACS chief dental practitioner was on leave at the time of the inspection. A locum dentist was contracted by NIHRACS to fill the dental position in the meantime and all training and qualification records were sighted at the time of the inspection. 

Radiation protection

Radiation safety officer/Radiation safety committee

NIHRACS Work Health and Safety (WHS) meetings are held on a monthly basis. Previous meeting minutes were observed during the inspection noting radiation safety as a standing agenda item.

NIHRACS Management has also implemented a hospital wide QA program; however, there was no documented evidence of a dedicated QA program focussing on the dental and general radiology department’s operations at the time of the inspection. 

One radiation safety incident was tabled in February 2021 whereby staff entered the imaging room via a side door while OPG imaging/exposure process was underway. Investigation noted that warning signs had not illuminated while the OPG was operating. Corrective actions have been implemented and will be finalised at next service.

Other specific areas for improvement identified during the inspection that related to the RSP included:

• There were no unique identifiers on the aprons or record of annual fluoroscopic examinations (section 3.3.2).
• There was no indication that general radiation awareness training for all hospital staff was being conducted (section 6.3.2). 
• There were no written standard radiology protocols including any protocol modifications specified for particular patients (section 8.2.2).
• There were no records of X-ray repeats or analysis of same at the time of the inspection (section 9.3.3). 

Ultimate disposal or transfer

Management of ultimate disposal or transfer

During the November 2019 inspection, a disposal pathway for the disused ‘Instrumentarium OPG’ stored in the NIHRACS maintenance area was being investigated. No section 65 application seeking approval from the CEO of ARPANSA for disposal of the apparatus has since been received from NIHRACS. This X ray unit has, however, been subsequently disposed of in apparent non-compliance with section 65 of the Regulations.  

Findings

The inspection revealed the following non-compliances:

1. Disposal of controlled apparatus – decommissioned OPG as identified in 2019 inspection and dental X-ray unit in dental surgery 1 room – without CEO approval. (Prior approval is required under section 65 of the Regulations.)
2. Inconsistencies with NIHRACS SIW and controlled apparatus serial numbers in both dental and radiography suites and update SIW accordingly. (An accurate inventory is required under section 62 of the Regulations.)

The inspection revealed the following areas for improvement:

1. The current generic Radiation Safety Plan did not reflect all operational practices within the NIHRACS Radiology and Dental departments and contained some outdated references to codes and standards.
2. Deficiencies in the marking and testing of lead aprons.
3. Lack of radiation awareness training for general NIHRACS staff.
4. Lack of written standard radiography protocols.
5. Lack of a monitoring and review process for X-ray repeats. 
6. There was no quality assurance system for the radiology and dental departments. 

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