The Stephen Review

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Terms of Reference

The Review's Terms of Reference were to:

examine and report on the safety and quality of the production and supply of blood and blood products for use in the Australian health care system;
recommend strategies to attain or maintain safety and quality at best practice standards and to bring about sustainable improvements, including mandatory compliance with a national quality assurance program;
recommend how the system might best be drawn together to ensure it meets Australia's needs into the future;
consider and recommend ways to improve the system-wide decision making processes, including the provision of timely, expert advice on the safety, quality and supply issues that arise from time to time. Among other things, the advice was to cover:

the need for and financial impact of new testing procedures and new products;
legal and ethical issues where access to products may have to be based on clinical priorities;
cost effectiveness of proposed safety improvements;
the role of an expert reference laboratory in setting and maintaining a national quality assurance program; and
the impact of change on public confidence in the blood supply.

consider and report on strategies to increase the supply of plasma products currently in short supply, including a review of the principle of self-sufficiency and consideration of the consequences of sourcing additional product from overseas suppliers; and
assess the economic and productive capacity of the Australian plasma fractionation industry to balance future domestic needs against export opportunities and, after taking note of any safety implications, recommend strategies to improve that capacity.

Major Recommendations of the Review

The Review acknowledged that Australia has a blood sector of which it can be justifiably be proud, and the debt the nation owes to its volunteer blood donors. However, the Review found there was scope for improvement that, if implemented, would lead to a better system for recipients, donors and service providers.

The Review's recommendations related to:

safety and quality in the supply and clinical use of blood;
planning and managing supply needs;
information, monitoring and research; and
governance and the need for a national approach.

Safety and quality in the supply and clinical use of blood

The Review endorsed, and in some areas recommended, strengthening the role of the independent national regulator, the Therapeutic Goods Administration (TGA), for example, in the development of national donor standards.

Strengthened external quality assurance for laboratories involved in testing of donated blood was also recommended by the Review, and a number of mechanisms for achieving this were identified.

Importantly, and contrary to public perception, the major risks of transfusion currently lie in the clinical use of blood in hospitals, rather than with transmission of infectious agents through the supply. Available data from overseas show that many adverse transfusion events are preventable. Australia has no national scheme for monitoring adverse events or patient outcomes associated with the use of blood and blood products.

The Review recommended the introduction of a comprehensive surveillance and adverse incident reporting system in hospitals, linked to broader patient safety initiatives. Data from such a monitoring scheme would be useful for initiatives to improve clinical practice, and put the risks of transfusion in perspective. Hospital transfusion committees may support such haemovigilance schemes at the local level.

A need for collaboration between the Australian Council for Safety and Quality in Health Care and others to plan and support this work was identified.

Planning and managing supply needs

The Review recommended establishing a statutory National Blood Authority to undertake national supply planning and management, and to develop and implement contingency planning to manage supply risks.

The Review proposed that the Authority would administer new agreements to be negotiated by the Commonwealth with service providers (ARCBS and CSL Limited) on behalf of the Commonwealth and the States and Territories. It would also play a role in national quality assurance and information management and reporting, by pulling together centrally information from a variety of sources and providing an overview of the sector's performance to guide policy and other decisions.

Information, monitoring and research

The Review recommended that the National Blood Authority be charged with responsibility for developing a national information management plan and working with the National Health and Medical Research Council on research and development priorities for the sector. It argued that these proposals are essential for decision making and for improving quality throughout the sector, both on the supply side and in the clinical use of blood and blood products.

A national information management plan would link all parties, including the ARCBS, CSL Limited, hospital blood banks, infectious disease surveillance and haemovigilance schemes, allowing them to keep pace with developments such as emerging infectious agents and opportunities to improve transfusion practice.

Areas where further research is required and where Australia is well placed to contribute to international collaboration were identified, for example:

research with donors, to build improved understanding of donor characteristics, and attitudes, and behaviour;
evaluating the cost effectiveness of new technologies prior to implementation;
scanning the horizon for the potential impact of regulatory changes and other developments; and
researching transfusion practice, and opportunities for improvement.

Governance and the need for a national approach

The Review recommended a national, as opposed to a jurisdictional, approach. In proposing a partnership approach to this complex and important sector, the Review recommended an intergovernmental agreement to give effect to proposed changes.

The Review proposed substantially fewer funding agreements, with increased accountability and efficiency in administration. It also recommended that expert advice to guide national policy be drawn from the National Blood Authority and existing health infrastructure and arrangements, including the National Health and Medical Research Council, the National Public Health Partnership, the Pharmaceutical Benefits Advisory Committee, the Australian Council for Safety and Quality in Health Care, and the National Institute of Clinical Studies.