The audit reviewed the Commonwealth management and regulation of plasma fractionation. The audit objectives were to:

• assess the administrative and financial effectiveness of the Department of Health and Aged Care's contract management of the PFA;
• assess whether the TGA's implementation of post sale regulatory arrangements adequately protects the community's interests; and
• assess the extent to which agencies have implemented the recommendations made in Audit Report No.14 1995-96 concerning funding of plasma products and regulation of plasma products manufactured under the PFA.

The objectives of the audit were to assist the Department in the timely identification of any deficiencies in the evaluation of responses from suppliers and options for addressing the deficiencies. The objectives were to:

• test the Department's adherence to Commonwealth Procurement Guidelines for open and effective competition and to legislative and other Government specified requirements; and
• provide a report to the Parliament, the Government and other interested parties on the probity of the evaluation process.

The scope of the audit was restricted to considering the processes employed by the Department in the selection of hearing devices for use under the voucher scheme.