National Blood Authority Australia

Annual Report 2010–11

Part 4: Performance: Improving the Sector and its Management of Risk

Management of Risk

The NBA continues to give high priority to our obligation to manage blood sector risks, especially those related to supply security. We do this by ensuring that responsibility and accountability lie with those best placed to manage risk.

A key strategic direction for the NBA in 2011-12 in managing risk in the blood sector was to improve data capture, and the capacity to analyse data, across all sections of the blood supply chain (see pages 62-68). Other activities during the year included:

  • continued scrutiny of compliance with, and the quality of, risk management strategies contractually required of suppliers
  • development of an overall financial reserve strategy
  • management of both real and potential risks to the supply plan during the year
  • identification of jurisdictional preparations for managing risk.

National Blood Supply Contingency Plan (NBSCP)

The NBA activated the NBSCP once during the year, on 8 March 2012. On the previous day CSL Limited had advised the TGA that a small leak of ethylene glycol from the cooling jacket of a pasteurisation vessel used in the manufacture of albumin had been detected, and that use of the affected vessel had immediately ceased and repairs conducted. In response to this threat of contamination, the TGA had then recalled 140 batches of albumin manufactured by CSL Limited.

Albumin is a plasma-derived product routinely used in the treatment of patients in intensive care and the recall created a potential shortage of albumin stocks nationally. The NBA closely monitored the situation but was able to deactivate the NBSCP on 18 April following testing and release of quarantined batches of product by the TGA.

Apart from this event, inventory levels for all products remained strong throughout the year.

Management of risk in states and territories

In September 2011 the JBC considered information on the preparedness of states and territories for emergencies involving blood. Three categories of emergencies were identified: blood supply shortage; short-term surge in demand for blood products; and disruption to infrastructure. Several key issues were identified regarding the ability of jurisdictions to respond to emergency planning, including:

  • clarification of roles of key stakeholders
  • resourcing
  • the importance of consistency in content and dissemination processes, and of key messages
  • transport
  • periodic testing of contingency arrangements.

JBC members acknowledged the value of conducting simulation exercises, provided adequate resources were available, and agreed to work towards addressing known gaps and to reporting annually on their preparedness.

Financial risks

The NBA has a range of assurance and controls measures in place to manage financial risks that are reviewed regularly both internally and externally. These include a rolling internal audit program, Audit Committee oversight of the governance framework, and contract risk plans.

Contracts with commercial suppliers of blood and blood products, and the implementation of the output based funding model with the Blood Service, have introduced financial risks for the NBA. The NBA's overall financial reserve strategy, developed during 2010-11, acts as a safety net to manage financial risks associated with these and future contractual arrangements.