3.2 Fresh blood products
'The signing of the Deed will assure governments of best practice governance and cost-effective blood supply.'
The National Blood Authority manages the relationship with the Australian Red Cross Blood Service—the sole supplier of fresh blood products in Australia. During the year the signing of the Australian Red Cross Society Deed of Agreement was achieved and the Australian Red Cross Blood Service business study commenced.
Australian Red Cross Society Deed of Agreement
A landmark agreement for the management and supply of fresh blood products and services was struck early in the financial year. A Deed of Agreement between the Australian Red Cross Society and the Australian Government (acting through the National Blood Authority) was executed on 21 August 2006. The Contingency Funding and Supply Arrangement that governed the relationship between the Australian Red Cross Blood Service and governments up until this time was terminated by a side letter agreed on the date of signing of the Deed.
The Deed is a complex document, representing a huge amount of work for both the National Blood Authority and the Australian Red Cross Society and Blood Service. It embodies a set of terms and provisions that ensure, at a minimum, the requirements and policy parameters determined by the Jurisdictional Blood Committee. These include Australian Red Cross Blood Service compliance with best practice governance requirements, performance measurement and reporting, output pricing and national safeguards to ensure value for money and the interests of governments and the community are met.
The Deed also features a schedule for a transition-in period to accommodate the Australian Red Cross Blood Service in developing systems and procedures to meet obligations under the Deed which it was not yet fully equipped to deliver but which would represent improvements in the service and compliance with government requirements.
Implementation of the Deed is so far progressing well, with a sincere commitment on the part of the Australian Red Cross Blood Service and the National Blood Authority to achieving their respective obligations. Communications between the two organisations are cooperative and productive and include:
- the National Blood Authority's General Manager and the Australian Red Cross Blood Service Chief Executive Officer meeting on a quarterly basis to review Australian Red Cross Blood Service's planning, progress and performance and to discuss strategic issues of interest to both parties
- the Chief Financial Officers meeting quarterly, and the Australian Red Cross Blood Service capital planning, financial management and reporting showing a marked improvement since the execution of the Deed
- the Deed management teams of both the Australian Red Cross Blood Service and National Blood Authority meeting on a regular basis and as needed to discuss operational Deed implementation issues.
The Deed management teams were involved in a number of activities to ensure appropriate implementation of the Deed, including the development of protocols and joint arrangements to put various provisions of the Deed into operation—for example, third-party reviews and public affairs management and communications. Key performance indicators have been set and are being measured and reported.
A series of processes have also been instigated in the Australian Red Cross Blood Service capital works program and funding, which represents approximately 10 percent of its total operating budget. To ensure that the provision and management of these capital funds is streamlined and efficient, the National Blood Authority is developing a series of guidelines in cooperation with the Australian Red Cross Blood Service.
The National Blood Authority also has responsibility for assessing and critiquing requests for capital funding made by the Australian Red Cross Blood Service, the most important of these relating to premises. The National Blood Authority is currently assessing an Australian Red Cross Blood Service business case for the relocation of the Sydney principal site in the next five years.
Under the Deed, a number of initiatives are being undertaken, including the development of service level agreements between Approved Health Providers and the Australian Red Cross Blood Service. The National Blood Authority and the Australian Red Cross Blood Service have collaborated in the development of the National Blood Supply Contingency Plan and other risk management initiatives.
The execution and implementation to date of the Deed represents a new phase in the relationship between the Australian Red Cross Blood Service, the Australian Red Cross Society and governments. The National Blood Authority looks forward to further developing, consolidating and enhancing that relationship.
Australian Red Cross Blood Service funding and product mix
Australian Red Cross Blood Service funding in 2006–07 was $325.7 million—see Table 7.
The growth in funding reflects increased demand and changes in the product mix for fresh blood products. Figures 7 and 8 show the changes in product mix for red blood cells and platelets over the past five years.
Buffy coat
Buffy coat is the cells remaining after the bulk of the mature erythrocytes and plasma has been removed by sedimentation or centrifugation. This fraction is rich in platelets and leucocytes. Buffy coat poor cells have significantly reduced platelets and leucocytes.
Deed of Agreement: enhancing accountability and ensuring outcomes
Prior to 2003, the Australian Red Cross Blood Service's products and services in each state and territory were funded by the individual jurisdictions and managed on a grant basis for both capital and operating costs. A proportion of this funding was provided by the Australian Government. The Department of Health and Ageing and the Australian Red Cross Society reached an interim agreement for the national provision of services from 1 July 2003, while the Deed of Agreement was being negotiated between the parties.
Since its establishment in 2003, the National Blood Authority has worked with the Australian Red Cross Blood Service to develop a Deed to meet the needs of the Australian, state and territory governments in a single national agreement. The negotiation process was complex and extensive and needed all parties to have a good understanding of the required outcomes.
On 21 August 2006, the first formal national Deed of Agreement for the operation of the Australian Red Cross Blood Service was signed, ensuring the continued provision of blood and blood-related products for the benefit of all Australians and strengthening a relationship that guarantees cooperative planning and transparency of outcomes.
The three-year Deed represents an opportunity for improvements in the quality, efficiency, transparency and responsiveness of the blood sector to the needs of the clinical and government communities. The arrangements for the collection, production, testing and distribution of blood and blood-related products are agreed in the Deed. A range of associated services provided by the Australian Red Cross Blood Service, including benchmarking activities, management of access to IVIg and the provision of advice, education and support on transfusion-related issues, are also included.
Australian Red Cross Blood Service business study
In conjunction with the execution of the Australian Red Cross Society Deed, a second side letter outlined the arrangements for a business study of the operations of the Australian Red Cross Blood Service. This was part of a funding package agreed by the Australian Health Ministers' Conference in April 2006 to address Australian Red Cross Society and Australian Red Cross Blood Service funding requirements.
Consultation and open communication were essential to the initial success of the business study and enabled the study's terms of reference to be agreed.
The business study has been designed to:
- establish the fair and reasonable operational and capital costs of the Australian Red Cross Blood Service for the provision of fresh blood products and blood-related services required by governments under the national blood arrangements
- determine the efficiency and effectiveness of Australian Red Cross Blood Service financial governance and services arrangements
- describe and review the output-based funding model based on the volume and mix of products, and product unit payments
- advise governments on the costs and options for implementing new blood safety measures, including universal bacterial contamination testing of platelets and universal leucodepletion of platelets and red cells.
An Expert Advisory Committee was established to advise the National Blood Authority's General Manager on the conduct of the business study and met twice before 30 June 2007. Members of the committee are:
- Mr Michael Roche, Independent Chair
- Ms Kerry Flanagan, Department of Health and Ageing
- Mr Ken Barker, New South Wales Department of Health
- Professor Brendon Kearney, Institute of Medical and Veterinary Science
- Mr Robert Tickner, Australian Red Cross Society
- Dr Robert Hetzel, Australian Red Cross Blood Service
- Dr Philippa Hetzel, Australian Red Cross Blood Service
- Mr Garry Richardson, National Blood Authority Board.
Business cases
The strategic and business planning processes established in the Deed provide for the development of business cases for initiatives that can be demonstrated to meet government and Australian Red Cross Blood Service future priorities.
During 2006–07, the National Blood Authority coordinated advice to the Australian Health Ministers' Conference in response to several business cases submitted by the Australian Red Cross Blood Service.
National Managed Fund
On 1 July 2000, the Australian Health Ministers' Advisory Council established the National Managed Fund to cover future liability claims made against the Australian Red Cross Blood Service in relation to blood and blood-related products in Australia. The National Managed Fund came about because of the non-availability of suitable and affordable commercial insurance cover for the Australian Red Cross Blood Service for blood-borne disease liability, and the Commonwealth, the states and the Australian Red Cross Blood Service will periodically review changes in the commercial insurance market in this regard.
In 2006–07, the claims management and advice service provider and the National Blood Authority finalised contract negotiations. Regular reporting was commenced on the required services under the contract. The provider has developed a draft claims manual for the National Blood Authority's consideration.
Overseas supply of blood products
A policy for issuing blood and blood-related products for Australians' use overseas, and for humanitarian purposes, was formalised on 30 March 2007 at the Australian Health Ministers' Conference. At the same time, the Australian Health Ministers' Conference agreed to amendments to the National Blood Agreement to allow supply of blood and blood-related products for use overseas and to enable cost recovery where appropriate. This policy enables Australians who need blood and blood-related products to access them while overseas and ensures that Australia will continue to provide blood and blood-related products for humanitarian and disaster relief.
Service Level Agreement project
In 2006–07, the National Blood Authority gained the Jurisdictional Blood Committee's endorsement to develop a pilot Service Level Agreement between the Australian Red Cross Blood Service and Approved Health Providers which receive blood products. The support for this project recognises the reliance of the Australian Red Cross Blood Service and jurisdictions on the cooperation and good practices of Approved Health Providers to help achieve the appropriate management of blood and blood-related products in hospitals. This includes integration of planning and demand management, comprehensive reporting on product usage, appropriate storage and inventory management.
These Service Level Agreements are designed to be supported, where appropriate, by agreements between jurisdictions and their Approved Health Providers. The agreements aim to articulate the Jurisdictional Blood Committee's safety and quality expectations of recipients of government funded blood and blood-related products, including supporting appropriate use of products by clinicians in hospitals. Agreement has been reached to pilot a draft Service Level Agreement in two jurisdictions for assessment and consideration by others.
Product change proposals
Under the National Blood Agreement, interested parties can make proposals for changes to products or services on the National Products and Supply List. Schedule 4 of the National Blood Agreement provides for evidence-based evaluation, information and advice to be provided to support decisions on these changes.
In 2006–07, the Jurisdictional Blood Committee determined that a suitable health economic evaluator should be procured to design a purpose-built methodology and framework to evaluate national blood supply change proposals and to apply the methodology and framework to the evaluation of all applications the National Blood Authority receives. An initial procurement process in December 2006 was unsuccessful in identifying an organisation to develop this methodology. As a result, the National Blood Authority separated the required work into two discrete sections and is currently investigating options for progressing it. It is expected that the evaluation framework will be developed and the first proposal presented for decision in 2007–08.
Improving blood safety
The rigour already applied to blood safety assures Australians of a safe and secure blood supply. In 2006–07, the National Blood Authority coordinated analysis and advice to the Australian Health Ministers' Conference, which gave in-principle support for the Australian Red Cross Blood Service to introduce two manufacturing procedures to ensure Australia maintains a safe and secure supply of blood. These are the universal leucodepletion of red blood cells and platelets and the universal bacterial contamination testing of platelets.
Universal leucodepletion
Leucodepletion is the removal, by filtration, of white blood cells (leucocytes) from red blood cells and platelets to decrease the likelihood of a patient experiencing an adverse reaction or event. Currently the Australian Red Cross Blood Service leucodepletes 16 percent of red blood cells and 80 percent of platelets nationally. This policy will result in universal leucodepletion nationally by 2010–11.
Universal bacterial contamination testing of platelets
Platelet components are presently stored at room temperature for up to five days and, as such, provide a natural growth medium for bacteria that may have been introduced through skin puncture or an underlying microbial bacteria load from the donor. When the blood is transfused into a patient, who may be immuno-compromised, there is potential for septic complications. Currently the Australian Red Cross Blood Service monitors bacterial contamination of platelet components in a regular quality control program. It is estimated that universal bacterial contamination testing of platelets will reduce the incidence of platelet contamination by 90 percent and is consistent with recommendations in the Council of Europe guidelines. Bacterial contamination testing is expected to be implemented by April 2008.