SSBA Fact Sheet 7 Monitoring and Compliance - June 10

The purpose of the SSBA Fact Sheets is to support the education and awareness of the SSBA Regulatory Scheme and provide information to stakeholders on topics of particular interest.

Page last updated: June 2010

PDF printable version of Fact Sheet 7 Monitoring and Compliance - June 10 (PDF 200 KB)

Release Date: June 2010

Entities and facilities handling security sensitive biological agents (SSBAs) must comply with the requirements of the National Health Security Act 2007 (NHS Act), the National Health Security Regulations 2008 (NHS Regulations) and the SSBA Standards. The Department of Health and Ageing (DoHA) monitors compliance with the SSBA Regulatory Scheme through the registration process, reports, audits and inspections of entities and facilities handling SSBAs.

When seeking registration to handle an SSBA, entities need to complete a declaration of compliance with the SSBA Standards.

DoHA aims to encourage compliant behaviour in a cooperative manner by monitoring through an inspection scheme. Inspectors have been appointed to audit compliance
with the NHS Act, NHS Regulations and the SSBA Standards. All of the necessary monitoring powers have been included in the NHS Act, including offence-related
warrants that provide extensive powers to search premises and seize evidential material.

The Office of the Gene Technology Regulator provides inspectors for the SSBA Regulatory Scheme under an agreement with the Office of Health Protection. Inspections commenced in August 2009 and involve both registered and nonregistered facilities handling Tier 1 and/or Tier 2 SSBAs or suspected SSBAs. Each inspector has been provided with an SSBA Regulatory Scheme inspector identification card, which should be sighted by entities and facilities prior to each inspection.

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Monitoring inspections will vary in length depending on the type of inspection. The types of inspections include:

  • Routine inspections – to determine whether the NHS Act, NHS Regulations and SSBA Standards are being complied with. They will also assist in the education of the facility user(s) about their obligations under the SSBA Regulatory Scheme. Routine inspections may also result in a follow-up inspection, if necessary
  • Review visits – to visit every facility to check performance in specific areas (previously identified during the routine inspection of the facility)
  • Audits – are a comprehensive examination of an organisation’s activities that may also include visit(s) to the organisation
  • Formal investigations – inquiries into allegations of a breach of the NHS Act, NHS Regulations or SSBA Standards
  • Unannounced ‘spot checks’ – a subset of routine monitoring and can also form part of follow-up checks or reviews.
To improve compliance, initially, monitoring inspections will focus on communication and education, and the provision of advice. However, the NHS Act provides for legal action to be taken in the event of non-compliance(s). For example:
  • DoHA may provide advice on rectifying the non-compliance
  • DoHA may direct the entity to dispose of the SSBA
  • DoHA may direct a particular individual to stop handling SSBAs, or to handle the agents only after fulfilling specified conditions
  • an entity may be prosecuted for an offence under the NHS Act.
There are no charges to entities and facilities for monitoring and compliance inspections and audits.