LOGISTICS ASSURANCE BRANCH Logistics Assurance Branch

LAB/OUT/2015/330

Chief Inspector Head of Regulatory Services Australian Radiation Protection and Nuclear Safety Agency PO Box 655 MIRANDA NSW 1490

DYNARAD X-RAY INCIDENT 2013 – RESPONSE TO ARPANSA LETTER

1. Thank you for your letter R15/11905 of 14 September 2015, in which you raisedconcerns with Defence’s management of radiation safety in light of the 2013 Dynarad x-ray incident that occurred in Fregon, SA during the Army Aboriginal Community Assistance Program (AACAP 13). As a result of your letter, Defence has reviewed its corporate plans and arrangements, as well as the local response to the incident, and has put in place a comprehensive plan of measures to prevent a reoccurrence. Your specific queries are dealt with in the following paragraphs.

Compliance Testing

2. The Director of Army Health (DAH) confirms that no periodic compliance testingwas conducted on the subject Dynarad x-ray apparatus in 2012.

Safety Management

3. This incident identified that Army had appropriate plans and arrangements asrequired under sub-regulation 49(2) of Reference B, including 2 GHB SOP 041. Non-compliance with paragraph 13(e) of SOP 041 was determined to be the result of human error. Army has since undertaken several remedial actions to prevent a reoccurrence, which are detailed later in this letter.

Primary Responsibility for Safety

4. ARPANSA’s concerns with the comment in the initial accident notification, to theeffect that ‘ARPANSA will be contacted for dose calculations’, are agreed. The wording of para 102 of Section 3 of the Joint Health Command (JHC) Radiation Safety Management Program and Radiation Management Plan (RSMP & RMP) is incorrect and will be rewritten.

5. Although DRSE and JHC personnel worked collaboratively with ARPANSA staff onthe development of the initial RSMP & RMP, neither office has retained a copy of the change management trail and the responsible JHC Radiation Safety Officer has since moved-on. In the light of this incident, and earlier (non-safety related) issues within the chain-of-command, the RSMP & RMP is to be separated into separate documents to allow better alignment with the corporate RSMP and rewritten to incorporate the lessons learned from this incident.

FOI 339/15/16Serial 4

Waiving of Requirements

6. Australian Standards (AS/NZS 3551, AS/NZS 3200.2.7 and AS/NZS 3200.1.3)mandate an annual technical inspection for x-ray equipment. Defence policy for the technical regulation of land materiel places an additional requirement for technical inspections, so that they are undertaken every six months, effectively doubling these mandatory maintenance requirements. The CO waiver is used to modify the requirement for this additional technical inspection in order to meet operational contingencies but it cannot waive the mandatory annual requirement.

Prevent, Investigate and Rectify Breaches

7. Defence manages the requirements of Regulations 44 and 45 through its corporateradiation safety governance system, which is based on a radiation safety statement from the joint licence holders (Secretary of the Department of Defence and the Chief of the Defence Force), a corporate Radiation Safety Management System, a subordinate Radiation Safety Management Program for each Group or Service that deals with controlled radiation sources and a Defence Radiation Safety Manual (DRSM) that provides corporate policy for managing such dealings.

8. In the case of this specific incident, and in addition to the corporate documentsmentioned above, Army had adequate systems in place, per the Army RSMP and the Technical Regulation of Army Materiel Manual (TRAMM), to enable compliance with the requirements of Regulations 44 and 45 as follows:

a. The holder of a licence must prevent breaches of conditions. Army observes thecorporate radiation safety governance system, which is enforced through its chain-of-command.

b. The holder of a licence must investigate suspected breaches of conditions. Armyconducted an investigation into the damage that occurred to the x-ray apparatusduring AACAP 2013, as required by the DRSM. Compliance testing was addressedwithin that investigation.

c. If the holder of a licence identifies a breach, the holder of a licence must rectify thebreach and any consequences of the breach. The x-ray apparatus was immediatelyremoved from service and the overdue compliance test (and necessary repairs) wasconducted with the receipt of a compliance certificate on 23 October 2013.

d. If the holder of a licence identifies a breach, the holder of a licence must also tell theCEO as soon as reasonably practicable. ARPANSA was advised of the incidentand the possible non-compliance by email on 17 September 2013, as part of theimmediate actions carried out by the radiographer in charge.

Summary of Measures Taken to Prevent a Reoccurrence

9. Accordingly, I believe that Army undertook all reasonably practicable steps tocomply with Regulations 44 and 45. Notwithstanding, and as a result of its investigation, Army has identified improvements to its subordinate plans and arrangements that could augment compliance, which have subsequently been implemented, as detailed below:

a. Amendment of SOP 041 has been endorsed by DAH.

b. Professional performance counselling has been given to personnel involved in theincident to identify areas requiring education and improvement, especially withregard to their responsibilities under sub-regulation 49(2).

c. Comprehensive training and awareness for all radiographers, both permanent andreserve, within the Medical Imaging Department, including the requirements andimplications of the JHC RSMP & RMP.

d. Development of Army Health Instruction 14 Regulatory Compliance for ArmyRadiological Officers and Respective Commanders (copy attached) to detail theprocedures that must be followed by Army radiological officers and commanders toprovide safe and effective radiological services that conform to Defencerequirements.

e. Inclusion of the requirement for compliance testing in the TRAMM to improvegovernance.

f. Consultation with the external provider for technical inspections and compliancetesting (AUREUZ) regarding their conduct of a technical inspection that did notidentify the overdue compliance test, resulting in modifications to their processes inorder to prevent a reoccurrence.

10. My POC for this matter is Mr Tony Mills-Thom (Director DRSE) who can becontacted on (02) 6266 4027 or email tony.mills-thom@defence.gov.au.

B. Stewart, OAM Executive Director Logistics Assurance

CP4-2-140 PO Box 7913 Canberra BC ACT 2610 (02) 6266 4242 benjamin.stewart4@defence.gov.au

12 October 2015

Enclosure: 1. Army Health Instruction 14 – Regulatory Compliance for Army Radiological

Officers and Respective Commanders

Department of Defence

ARMY HEALTH INSTRUCTION 14 10 August 2015 This Instruction is issued by Director General Army Health Services, with the authority of the Chief of Army in accordance with Defence Instruction Army (Personnel) 124-3 Role and Functions of the Army Health Services.

Note: These instructions are of a permanent nature and remain in force until cancelled. They should be reviewed by the sponsor every three years and repromulgated only where a significant change of content is necessary. Publications can be accessed on the Defence Intranet (http://intranet.defence.gov.au/home/documents/departme.htm)

REGULATORY COMPLIANCE FOR ARMY RADIOLOGICAL HEALTH OFFICERS AND RESPECTIVE COMMANDERS References: A. Australian Radiation Protection and Nuclear Safety Act 1998 B. Australian Radiation Protection and Nuclear Safety Regulations 1999 C. Defence WHS Manual Oct 12 D. Defence Radiation Safety Manual June 13 E. JHC Radiation Safety Management Program and Radiation Management

Plan of Nov 12 F Army Radiation Safety Management Plan Nov 13 G DI (A) OPS 68-1 Military Risk Management. Introduction

1. The administration and delivery of radiological health services in Defence issubject to Commonwealth laws that affect regulation, reporting and compliance. It is recognised that these laws apply to Defence activities whether in training or operational environments or when providing aid to the community.

Aim

2. The aim of this Instruction is to detail the procedures that must be followed toallow Army Radiological Health Officers to provide safe and effective radiological health services IAW Defence and national requirements.

Application

3. This Instruction applies to the delivery and administration of radiologicalhealth services by the following personnel:

a. radiographers and radiologists

b. dental officers and senior dental assistants

c. health personnel within the chain of command.

4. Relevant definitions can be found at Annex A.

UNCONTROLLED IF PRINTED

2

Authority

5. The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) regulates Commonwealth entities that use hazardous radiation sources. It does so to protect people and the environment from the harmful effects of radiation. ARPANSA undertakes research, provides services, and promotes national uniformity and the implementation of international best practice across all jurisdictions.

6. The Australian Radiation Protection and Nuclear Safety (ARPANS) Act at Reference A provides the legislative framework for the management of radiation protection and nuclear safety across the Commonwealth. The ARPLANS Regulations at Reference B provide for a licence and regulatory regime to give effect to the Act. References A and B are implemented through respective Defence documents and are to be complied with at all times.

7. The Defence Work Health and Safety Manual at Reference C is the primary source of corporate Work Health and Safety policy in Defence. The Defence Radiation Safety Manual (DRSM) at Reference D provides the corporate radiation safety policy for Defence in support of the Defence Radiation Safety Management System (RSMS). The RSMS requirements are implemented within Joint Health Command (JHC) as the JHC Radiation Safety Management Program (JHC RSMP) while the tri service requirements for diagnostic radiography are implemented as the Diagnostic Radiography Radiation Management Plan (DR RMP). Both the JHC RSMP and the DR RMP are at Reference E. The RSMP-A at Reference F implements Army’s radiation safety management program.

8. This Instruction is issued to highlight the hierarchy of the referenced documents and the need for commanders and staff members employed in areas with radiological health risks to comply with all levels of regulation IOT ensure safe and effective practice within Army.

Army Radiation Safety Management Program (RSMP-A)

9. The RSMP-A at Reference F is authorised by Chief of Army and constitutes reasonable instructions to Australian Public Service (APS) personnel and a lawful order to ADF personnel. The RSMP-A is designed to be effected through application of Defence policy and maximum use of existing supporting systems (eg logistics assurance). The effect is delivered through the development and implementation of unit-level Radiation Safety Plans (RSP) and implementation of defined assurance mechanisms through the chain of command.

10. Army commanders/managers are responsible for reviewing the processes described in the JHC RSMP/DR RMP as well as the RSMP-A and ensuring that all requirements of both the JHC and Army plans are effectively implemented and resourced within their respective areas of control.

Responsibilities

11. The Directorate of Army Health (DAH) is responsible for ensuring that Army’s health related policies and procedures are compliant with JHC (as the technical health agency) and Director Defence Radiation Safety and Environment (DRSE) direction. Close interaction is required between Army Health and JHC to ensure Army health units comply with the JHC RSMP and RSMP-A to manage all health radiation sources subject to the ARPANSA licence. Reporting on radiation health issues will

UNCONTROLLED IF PRINTED

3

follow the Army chain of command in the first instance. However the JHC Radiation Safety Officer (RSO) must also be informed of events to ensure correct technical oversight and permit Defence health system development. In accordance with the JHC RSMP, DAH is responsible for appointing the ‘Army Senior Radiographer’.

12. Army Senior Radiographer (ASR). The Senior Radiographer 2nd General Health Battalion (2GHB) is appointed the Army Senior Radiographer. The 2 GHB Senior Radiographer duty statement and position on PMKeys will reflect this appointment as the ASR. DAH will ensure this occurs. If the identified ASR position is vacant at any time the CO 2GHB is to appoint the next Senior Radiographer as the ASR. ASR duties include:

a. representing Army on the JHC radiology and radiation safety cell (RRSC)

b. ensuring that Army concerns are considered during reviews of JHC policy and procedures pertaining to radiography, and that any residual issues are managed through Army policy/procedures

c. providing advice to the Army RSO on medical radiation safety matters.

13. Army Functional Commands. COMD FORCOMD, COMD SOCOMD and COMD 1 DIV are responsible for ensuring that the requirements of this RSMP-A are implemented effectively and resourced within their respective areas of responsibility. Commanders are to appoint a Command RSO, but have flexibility in terms of the supporting arrangements for that position. Commanders are to ensure that appropriately trained RSO are available to support the command chain and that required assurance mechanisms are in place. Commanders are to ensure that orders, instructions and procedures reflect the requirements of the RSMP-A.

14. Army Training Authorities. COMD FORCOMD is to ensure that Army Training Authorities (TA) identify the RADSAFE training requirements for allocated ECNs and that the Manual of Army Employments is updated to record those trades where radiation hazards are identified.

15. Commanders/Managers. Commanders and managers are to comply with the RSMP-A and positively reinforce RADSAFE within their respective areas. Units are to comply with relevant manuals, technical instructions, and advice contained within AHQ endorsed Provisional Design Acceptance (PDA) or Safety Case Reports (SCR). Where this is not feasible, units are to apply Military Risk Management strategies IAW Reference G. Further guidance on ionising radiation risk assessment is contained within Reference D at Chapter 8 Ionising Radiation Safety Implementation. Prior to completing a task, the minimum requirement is to consider the prescribed methods of work within the local context to ensure that no additional/local risks are introduced.

16. Personnel. Personnel are to comply with RADSAFE and related orders, policies, procedures (eg RSP, technical manuals, etc), and training. They are to perform all tasks in a professional manner with due care for their own and other people’s safety. Where any concerns exist they are to raise it immediately with their supervisor. Personnel are to report issues and incidents via the chain of command in the first instance and via external reporting mechanisms as required. Failure to report known issues may result in administrative or disciplinary action.

UNCONTROLLED IF PRINTED

4

17. Unit RSO. The Unit RSO is responsible for implementation of the RSP and ensuring the requirements of the DRSM are achieved. The choice of approach to compliance and appointment of the RSO is a chain of command responsibility.

Developing Radiation Safety Plans (RSP)

18. The creation and use of a unit level RSP is the key to the successful implementation of the RSMP-A. These plans should include the requirement for RADSAFE aspects to be considered during any review of new activities or facilities within the unit.

19. A RSP is required for any unit that has controlled radiation sources/apparatus. Commands and formations may raise RSP or refer to management requirements within WHS policy and directives. Higher level RSP should only be constituted where the risk warrants such action and it is of direct value to the management of RADSAFE.

20. The DRSA template for RSPS is the minimum requirement and mandated for use across Army. This achieves uniformity of approach and improves compliance. Units are authorised to add additional requirements where applicable to their circumstances. RSP must be reviewed annually and endorsed by an appropriately qualified RSO.

Incident Reporting, Investigation, Corrective and Preventive Action

21. Radiation safety events are to be reported and investigated IAW Chapter 3 of Reference D. If a radiation safety accident is notifiable to ARPANSA, then it must also be reported to DRSA and to the SO1 Army Safety Policy Programs (ASPP) who is responsible for maintenance of RSMP-A. Where investigations highlight potential systemic issues or causal factors that are outside the unit’s immediate control, the unit is to:

a. institute local controls until the matter can be resolved, including periodic monitoring of those controls to ensure that they are working

b. staff the identified issues through the chain of command and/or relevant technical chain for resolution (eg lodge a RODUM)

c. where the response is considered insufficient, units are to use existing staff processes to raise their concerns (eg through the chain of command/relevant technical agency complaints process, WHS committee/chain).

Reporting

22. Reporting of RADSAFE performance. Army uses reporting as a component of the continual improvement program. Reporting ensures that the RSMP-A is monitored, its performance improved, and that duty holders have sufficient oversight of the system to exercise their obligations.

23. Reporting of incidents and system failures. All units are to report radiation incidents through the existing Defence notification and reporting framework. Relevant agencies are to use this information when completing reviews of RADSAFE related orders, instructions, procedures, plans and work practices (ie doctrine, EMEI, RSP, RSMP-A, etc).

UNCONTROLLED IF PRINTED

5

24. Reporting of hazard identification. Army aims to identify hazards and appropriate controls during materiel procurement and sustainment processes. This process ensures that new hazards are identified to the chain of command and hence to affected personnel. Additional hazards identified during operation of land materiel must be reported via RODUM.

4. Reporting of hazard identification. Army aims to identify hazards and appropriate controls during materiel procurement and sustainment processes. This process ensures that new hazards are identified to the chain of command and hence to affected personnel. Additional hazards identified during operation of land materiel must be reported via RODUM.

25. Reporting on Sentinel. Defence personnel are required to submit radiation safety events via the Sentinel system whether they be for Defence employees, cadets or third parties (contractors and the general public). Some events may require additional reporting to Comcare. DRSE collects data on radiation safety events under the ARPANS Act.

25. Reporting on Sentinel. Defence personnel are required to submit radiation safety events via the Sentinel system whether they be for Defence employees, cadets or third parties (contractors and the general public). Some events may require additional reporting to Comcare. DRSE collects data on radiation safety events under the ARPANS Act.

Conclusion Conclusion

26. Commanders and staff members employed in areas with radiological health risks are to comply with all levels of regulation IOT ensure safe and effective delivery of radiological health services within Army. Compliance with the procedures outlined in this Instruction will enable personnel responsible for the delivery and administration of radiological health services to comply with relevant Commonwealth laws, regulations and Defence policies.

26. Commanders and staff members employed in areas with radiological health risks are to comply with all levels of regulation IOT ensure safe and effective delivery of radiological health services within Army. Compliance with the procedures outlined in this Instruction will enable personnel responsible for the delivery and administration of radiological health services to comply with relevant Commonwealth laws, regulations and Defence policies.

GM Whelan GM Whelan Brigadier Brigadier Director-General Army Health Services Director-General Army Health Services Annex: Annex: A. DefinitionsA. Definitions

UNCONTROLLED IF PRINTED

ANNEX A

DEFINITIONS

1. ARPANSA. The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) is the Australian Government's primary regulator for radiation protection and nuclear safety.

2. DRSE. The Defence Radiation Safety and Environment (DRSE) Directorate exerts technical control over the RADSAFE domain on behalf of Commander Joint Logistics (CJLOG). DRSE promulgates Defence radiation safety policy and corporate procedures via the Defence Radiation Safety Manual (DRSM).

3. Radiological Health officer. An authorised health officer, who is qualified in the respective radiological health field. This may be a fulltime or part time serving military member and also includes APS employed in this field.

4. RADSAFE. Is the acronym for Radiation Safety. The RADSAFE domain, which comes under CJLOG as the Single Point of Accountability for RADSAFE, is managed as a separate domain to the Workplace Health and Safety (WHS) domain within Defence and Army.

5. Radiation Safety Officer. The Radiation Safety Officer is appointed by the local Commander/Manager to manage their RADSAFE obligations under the ARPANSA Source Licence. 6. RSMP-A. The Army Radiation Safety Management Program (RSMP-A) provides the necessary direction to give effect to the Defence Radiation Safety Management System within Army.

UNCONTROLLED IF PRINTED