Release Date: July 2014
The National Health Security Act 2007 (NHS Act) requires entities to report the loss, theft, attempted theft or accidental release of security sensitive biological agents (SSBAs). This guideline outlines the circumstances that may distinguish between the loss, theft, attempted theft or accidental release of an SSBA.
This guideline does not set out the legal definitions of loss, theft, attempted theft or accidental release. Rather, it provides information to entities, facilities and individuals about their obligations in situations in which an SSBA is lost or stolen (or there is an attempted theft) or accidentally released during its handling at a facility.
The NHS Act and the National Health Security Regulations 2008 require a registered entity to report to the Department of Health (Health) and the police if an SSBA is lost or stolen. A note in the Act states that accidental or deliberate release of an SSBA that could cause harm to human health or the environment may also need to be reported to other regulatory schemes, agencies or Departments under state or territory legislation.
The NHS Regulations stipulate the following as reportable events for the SSBA Regulatory Scheme:
- accidental release of an SSBA during handling at a facility;
- if the registered entity becomes aware that there has been a theft or an attempted theft of the SSBA that the entity handles;
- if the registered entity is unable to verify that a transfer of the SSBA has been successful. What constitutes a successful transfer is defined under the SSBA Standards.
Lost versus stolen
The meaning of ‘lost’ is ‘no longer to be found.’ The broad meaning may include circumstances in which an SSBA is lost because it was stolen. However, the dictionary describes the meaning of ‘steal’ as ‘to take or take away dishonestly or wrongfully, especially secretly’.
The difference between the two reportable events is the knowledge of the cause of the loss of an SSBA. A loss may include a suspected, but unconfirmed theft while a theft is known to be caused by person wrongfully taking an SSBA. If it has been confirmed that an SSBA was stolen by either a known or an unidentified person, the event must be reported as a theft. If it is only suspected that the SSBA was stolen, it should be reported as a loss.
The loss of an SSBA may result from its accidental release during its handling at the facility and is a reportable event under the NHS Regulations. An accidental spillage of an SSBA such as a spill down the sink may cause an accidental release of the SSBA (through the drainage system) into the environment and must be reported to Health. However, an accidental spillage, which is contained within the facility and does not release the SSBA into the environment (e.g. a spill onto a bench top) is not a reportable event. For more information, see Guideline 2 – Registered Facility Reporting Requirements.