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Regulatory Guide - Reporting a serious incident (ARPANSA-GDE-1749WEB)
This Regulatory Guide is provided to assist licence holders on what is regarded as a serious incident involving controlled material, controlled apparatus or a controlled facility and the actions that must be taken if a serious incident occurs.
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The Code for Radiation Protection in Planned Exposure Situations (2020) (the Planned Exposure Code) requires licence holders to prevent and mitigate incidents involving controlled materials, controlled apparatus (both ionising and non-ionising) or controlled facilities.1 The licence holder must comply with the Planned Exposure Code under section 59 of the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations).
Section 58 of the Regulations requires the licence holder to notify the CEO of ARPANSA within 24 hours of becoming aware of an accident and to take other appropriate actions including providing a written report about the accident within 14 days.
NOTE: Any reference to ‘accident’ in the Regulations is taken to mean ‘serious incident’.
For the purposes of preventing a reoccurrence of a serious incident, section 58 requires the licence holder to review and update the plans and arrangements for managing safety that are relevant to the incident (including any internal safety approval system that authorised an activity that led to the incident.
The Planned Exposure Code defines an incident as any unintended event, including operating errors, equipment failures, initiating events, accident precursors, near misses or other mishaps, or unauthorised act, malicious or non-malicious, the consequences or potential consequences of which are not negligible from the point of view of protection and safety.2
The term ‘serious incident’ used in this guide is based on this definition of incident but only refers to those regarded as serious enough to require immediate reporting.
For the purposes of section 58 a serious incident is:
- A lost or stolen controlled apparatus or controlled material, excluding Group 1 sources3
- An unauthorised discharge of controlled material into the environment when the activity discharged exceeds 10,000 times the exemption limit4
- A radiation source out of control, for example: controlled material is not safely secured or shielded or contamination is not confined
- An event that is rated at or has the potential to be rated at Level 2 or above on the International Nuclear & Radiological Event Scale5 that is, exposure of a member of the public in excess of 10 mSv or exposure of a worker in excess of the annual dose limit
- A diagnostic or interventional medical procedure resulting in an observable acute radiation effect
- A package containing an unsealed source of more than 10,000 times the exemption limit that does not conform to RPS C-2 Code for Safe Transport of Radioactive Material or is damaged during freight, handling or transport in such a way that safety provisions are degraded
- Damage to or malfunctioning of a controlled apparatus or device containing controlled material where it is likely that a person could have received a dose in excess of the annual dose limit
- Contamination with or dispersal of a controlled material where a surface, substance or material is contaminated by a controlled material from the spillage of more than 10,000 times the exemption limit5
- Exposure to ultraviolet radiation which results in noticeable eye or skin damage
- Hazardous levels of radiofrequency leakage in a readily accessible area from an industrial radiofrequency heater.
Preserve the site
It is essential that the integrity of the site of a serious incident is preserved to allow an analysis of the conditions at the site and a thorough investigation as to the cause of the incident.
Special attention should be paid to the importance of securing the site or the facility to prevent any destruction or cross-contamination of the physical information as well as to protect responding personnel and others.
See Regulatory Guide: Radiation incident site preservation for further information.
Priority should be given to controlling and mitigating the consequences of the serious incident.
Notify ARPANSA within 24 hours
If a serious incident happens then ARPANSA must be notified within 24 hours of the licence holder becoming aware of it.
During normal business hours please call:
- your designated regulatory officer, or
- the Chief Regulatory Officer on (02) 9541 8331
Outside normal business hours please call:
- the ARPANSA 24 Hour Radiation Emergency Coordination Centre on (03) 9432 5384. Calls to this number will be responded to by the Duty Officer.
As soon as possible, complete a Serious Incident Notification Form and email it to licenceadminarpansa.gov.au.
Investigate and provide a written report within 14 days
When investigating a serious incident the following questions should be considered:
- What happened?
- How did it happen?
- Did an individual’s actions contribute to the incident?
- Why did it happen? Consider such things as environmental factors (e.g. distractions, shielding); human factors (e.g. experience, shielding, fatigue); controls (e.g. training, normal procedures, supervision); human and organisational factors (e.g. hazard identification, auditing, safety culture)
- Was the severity of the serious incident and its likelihood of occurrence accurately reflected in the risk assessment?
These questions will help identify the root cause and contributing factors with the ultimate aim to improve controls and conditions to support individuals’ actions and reduce the risk of recurrence.
A written report must be provided to ARPANSA that contains an account of the incident and its consequences including where possible:
- A root cause analysis
- An estimate of the dose received by any person
- An assessment of any impact on the environment
- An assessment of human and organisational factors
- Any corrective action taken as a result of the accident
- Actions taken to prevent the recurrence of similar events
- The impact on safety
- Identified security implications
NOTE: If the report is not the final version then the report should still be submitted within 14 days and clearly marked as a preliminary report. The final version should be provided within a reasonable timeframe.
Review of plans and arrangements
Following a serious incident the licence holder is required to review and update plans and arrangements for managing safety. This review should include the design process for equipment or processes relevant to the incident and the performance of the risk assessment, review and safety approval system that authorised an activity that led to the incident.
The licence holder must complete the review within 6 months of the incident happening and must provide the CEO with a written summary of the outcome of actions resulting from the review within 7 months of the incident happening. The CEO may extend these periods on request.
1 Section 3.1.15 and 3.1.16 of the RPS C-1 Code for radiation protection in planned exposure situations.
2 This is the definition of ‘incident’ in RPS C-1 Code for radiation protection in planned exposure situations. This definition is adopted for the purposes of s58 of the Regulations because it includes deliberate and malicious acts that are not usually defined as accidents but which ARPANSA requires licence holders to report as soon as possible.
3 Source groups are set out in section 4 of the Regulations
4 Exemption limits for each radionuclide are specified in Schedule 1 Part 1 of the Regulations
5 The International Nuclear & Radiological Event Scale User’s Manual, 2008 Edition