3.6 Supply and data management
National Supply Plan and Budget
The NBA plays the key role in coordinating an annual National Product List and National Supply Plan and Budget for approval by Health Ministers. As part of its role in managing the supply of blood and blood-related products, the NBA is responsible for:
- collecting data on products issued and reporting to jurisdictions against the approved supply plan
- making improvements to the national supply planning process
- monitoring the balance between supply and demand throughout the year
- intensively managing products in short supply.
The National Supply Plan and Budget for 2007–08 was $680.7 million as approved by the AHMC in March 2008 for the supply of blood and blood-related products. The actual demand for 2007–08 and funding by all jurisdictions was $703.0 million. This represents a $22.3 million increase, or 3.2%.
Move to universal leucodepletion of red cells
Leucodepletion is the removal of white blood cells (leucocytes) from red blood cells and platelets by filtration. This is done to decrease the likelihood of a patient experiencing an adverse reaction or event. In 2006–07, the AHMC gave in-principle support for the introduction of universal leucodepletion of red blood cells and platelets by 2010–11. In 2007–08, the ARCBS leucodepleted 27.6% of red blood cells and 87.1% of platelets nationally (see Figures 3.2 and 3.3). In April 2008, the AHMC approved bringing forward implementation of universal leucodepletion of red blood cells and platelets to 2008–09. This was achieved through the NBA’s coordination across jurisdictions and with the ARCBS on the cost and timing implications.
Universal bacterial contamination testing of platelets
Platelet components are 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 bacterial load from the donor. When the platelets are transfused into a patient, who may be immunocompromised, there is potential for septic complications. In April 2008, the ARCBS implemented universal bacterial contamination testing of platelets in accordance with the 2006–07 AHMC in-principle support for its introduction.
Table 3.9 Issues of blood products 2006–07 and 2007–08
| Non Fresh Blood Products | 2006–07 | 2007–08 | Variance | |
| Total Albumin | gms | 5 310 878 | 5 829 292 | 9.8% |
| Total IVIg | gms | 1 898 527 | 2 152 678 | 13.4% |
| Total Factor VIII | IU | 116 012 250 | 131 984 750 | 13.8% |
| Total Factor IX | IU | 18 422 500 | 21 322 500 | 15.7% |
| Total Rh (D) | IU | 68 561 175 | 68 777 800 | 0.3% |
| Hepatitis B | IU | 2 252 200 | 2 109 300 | –6.3% |
| Normal Immunoglobulin | mls | 13 920 | 16 280 | 17.0% |
| Tetanus | IU | 1 498 250 | 1 357 250 | –9.4% |
| CMV Immunoglobulin | vials | 2 370 | 2 421 | 2.2% |
| Zoster 1g 2ml | vials | 2 788 | 2 131 | –23.6% |
| Prothrombinex-VF | vials | 16 782 | 21 202 | 26.3% |
| Thrombotrol-VF | vials | 469 | 993 | 111.7% |
| Ceprotin | IU | 10 000 | 20 000 | 100.0% |
| Recombinant Factor VIIa | mgs | 26 119 | 16,570 | –36.6% |
| FEIBA inhibitor Treatment | IU | 2 202 500 | 4 121 500 | 87.1% |
| Factor XI | IU | 75 325 | 39 380 | –47.7% |
| Factor XIII Concentrate | IU | 110 000 | 149 750 | 36.1% |
| Fresh Blood Products | 2006–07 | 2007–08 | Variance | |
| Total Whole Blood Products | Unit | 1 145 | 801 | –30.0% |
| Total Red Blood Cells | Unit | 777 972 | 768 919 | –1.2% |
| Total Platelets (Adult Doses) | Adult Doses | 113 579 | 116 665 | 2.7% |
| Total Clinical FFP (Adult Doses) | Adult Doses | 145 874 | 144 987 | 11.0% |
| Total Cryoprecipitate | Unit | 49 333 | 51 957 | 5.3% |
| Total Cryo-depleted | Unit | 12 321 | 14 487 | 17.6% |
| Other Products | Unit | 8 705 | 6 371 | –26.8% |
| Plasma for fractionation | Kgs | 329 331 | 352 781 | 7.1% |
Sector information management and data strategy
There is a substantial amount of data available within the blood sector; however, there is no coherent information systems architecture integrating and serving the blood sector as a whole.
The National Blood Agreement
Under the National Blood Agreement, there are two primary policy objectives for the Australian blood sector.
To provide an adequate, safe, secure and affordable supply of blood products, blood related products and blood related services in Australia
To promote safe, high quality management and use of blood products, blood related products and blood related services in Australia.
To meet these obligations, given the wide range of information systems within the sector, the NBA has developed a sector information management and data strategy (SIMDS) this year. The primary objectives of the SIMDS are to provide a framework which supports the development of information management systems and the generation of data on blood and blood-related products that contribute, in a cost effective way, to:
- improved clinical outcomes
- improved cost-effectiveness and use of products
- a secure supply.
There are a number of approaches that could be taken in moving forward with sector data management. In the past, it has been common to attempt to build and impose large, national, integrated systems into an existing environment. Historically, this approach has been very costly and has had limited success.
A second philosophy has been the incremental approach, where system development is undertaken on an ‘as needed’ or ‘incremental’ basis. This involves understanding the existing environment, identifying gaps within it and developing systems to fill those gaps. To date, this has largely been the approach within the blood sector.
An alternate approach is to gain consensus on the data sets, requirements and standards needed to allow the collection of that standardised data through a diversity of systems. The ‘standard requirements’ approach proposes developing standards and a framework for achieving the information needed without necessarily having to build an information technology (IT) system. With this approach, jurisdictions and other stakeholders are able to collect the required data in ways that suit their business processes, yet the standards placed on the dataset means that national compilation of the data is possible. The SIMDS proposes a ‘standard requirements’ approach, as well as the use of incremental nationally sanctioned systems where needed.
JBC has agreed to the NBA developing a SIMDS to help guide a national approach to blood sector data. This will include using the strategy to set priorities applying the criterion developed within it to determine when national systems should be developed and when data should be gathered from existing systems.
Australian Bleeding Disorders Registry
In collaboration with a range of sector stakeholders, the NBA made significant progress on a project to redevelop the ABDR. The primary purpose of the redeveloped ABDR is to collect data that will contribute to improvements in the treatment and care of people suffering from bleeding disorders. This will occur on a range of fronts, delivering new capabilities for everyone involved in treating bleeding disorders. The ABDR will facilitate the collection of information which will be used to:
- build an accurate demographic profile of bleeding disorders in Australia
- keep clinical information such as treatment, bleed frequency, joint health, pathology, radiology, genetic mutation and others to provide information for assessment of treatment outcomes to improve care
- understand product use by diagnosis and enable governments to undertake supply planning and demand forecasting to secure an ongoing supply of clotting factor product.
Overseas supply of blood products
Under the National Blood Agreement, blood and blood-related products manufactured in Australia may be supplied for the personal use of Australian citizens travelling overseas and for humanitarian aid and disaster relief.
A policy for the provision of product overseas was endorsed by the AHMC in 2006–07 and the provision of these products is managed by the NBA, as set out in the National Blood Agreement.
In addition to those travelling or studying overseas, the NBA also facilitates the supply of blood and blood-related products for those Australians serving overseas and in international waters, such as the Australian Defence Force (ADF), Australian Customs Service (ACS) and the Australian Antarctic Division (AAD).
The NBA is particularly proud of its part in the redevelopment of the ABDR throughout 2007–08. The project, initiated in late 2006 (but starting in earnest in early 2007), has made marked progress. The redeveloped ABDR is expected to go live across all haemophilia treatment centres at the time this annual report is likely to be published in November 2008.
From its inception, the project has been an unprecedented example of collaborative effort and exercise in consultation. The project is overseen by a steering committee with clinical, patient and government representation. The key clinical organisation, the Australian Haemophilia Centres Directors’ Organisation (AHCDO), and haemophilia patient organisation, Haemophilia Foundation Australia (HFA) are represented. In fact, the chair of the Steering Committee is one of two AHCDO representatives: Dr John Rowell from the Royal Brisbane and Women’s Hospital in Queensland. To develop the statement of user requirements, Project Officer Ms Elizabeth Arnold conducted over 80 interviews across the sector encompassing government, clinicians, physiotherapists, social workers, nurses, data managers, transfusion medicine scientists, suppliers and 14 of the 16 haemophilia treatment centres across Australia. This developed a precise, comprehensive list of needs.
The level of consultation did not stop there. Representatives from key stakeholder organisations were involved in the development of the system, including representatives from AHCDO, the Australian Haemophilia Nurses Group, ARCBS and jurisdictions. Genix Ventures were the successful contractor and commenced system development in January 2008, conducting a workshop with all stakeholders. A reference group consisting of clinicians, nurses, data managers, physiotherapists, social workers, HFA and the NBA from across Australia have, and are, reviewing each reiteration to ensure the finished system meets the sector’s requirements in detail.
Due to the efforts of everyone in the bleeding disorders community, the ABDR is an example of collaboration at its best. The project reiterates the theme of World Haemophilia Day 2008, Count Me In. This event focuses on identifying and registering people with bleeding disorders and aims to deliver a world class system that meets the needs of all involved. It is well on its way to achieve this.
Overseas supply of blood products
Since its inception, the NBA has been involved in the supply of blood products and blood-related products to both Australian residents overseas and to non-Australian residents in the case of emergency or for humanitarian aid and disaster relief.
The supply of haemophilia products to Australian residents that are temporarily overseas allows those patients to conduct their lives to the fullest extent, safe in the knowledge that they have access to the same support that is extended to them when they are living at home. The NBA also facilitates the supply of blood products and blood-related products for those Australians serving overseas and in international waters, such as the Australian Defence Force (ADF), Australian Customs Service (ACS) and the Australian Antarctic Division (AAD).
Australia is widely recognised as a leader in the provision of humanitarian aid and disaster relief in the Pacific region, providing support services, financial aid and much needed medical and other supplies. In recent years, the NBA has supported these efforts through the supply of tetanus immunoglobulin to the Solomon Islands and Indonesia in response to the tsunami and devastating earthquake, respectively. As well as these coordinated efforts, the NBA, with the assistance of the Australian Red Cross Blood Service (ARCBS), has also approved the supply of products to our neighbouring countries to provide lifesaving or life-preserving aid on a much smaller scale. Recent examples include the provision of Rh(D) immunoglobulin to a patient who was 34 weeks pregnant in Papua New Guinea, Hepatitis B immunoglobulin to East Timor and Rh(D) immunoglobulin to Indonesia.
Following a minor change to the National Blood Agreement to allow supply of product overseas under the National Blood Arrangements, Jurisdictional Blood Committee (JBC) has now agreed to the funding mechanisms that will allow for greater equality between the states and territories when it comes to funding the various situations of supply overseas. Together with a recently endorsed internal NBA process, and a joint arrangement on overseas supply with ARCBS, the NBA will continue to make available the same products and services for Australian residents travelling or serving overseas, and in response to requests for humanitarian aid and disaster relief.
Review of distribution arrangements for blood products
In June 2008, the NBA advertised a request for tender for the Review of Distribution Arrangements for Blood Products (see Table 3.10). The NBA anticipates that the successful respondent will be appointed in September 2008 and tasked to deliver their recommendations in 2009.
The Review of Distribution Arrangements for Blood Products is an outcome from the Australian Government’s consideration of the Review of Australia’s Plasma Fractionation Arrangements (Plasma Fractionation Review5; PFR). The PFR was submitted to the Australian Government on 13 December 2006 and recommended, among potential areas for improvement, the optimisation of the distribution of blood products, particularly between the ARCBS and CSL Ltd Bioplasma. In response, governments endorsed a work strategy for the NBA to undertake the recommended Review of Distribution Arrangements for Blood Products in 2008.
Table 3.10 Terms of Reference for the Review of Distribution Arrangements for Blood Products
The 2006 Review of Australia’s PFA suggested there may be scope to improve the efficiency and effectiveness of current blood product distribution arrangements, particularly between the ARCBS and CSL Ltd Bioplasma. It recommended that the NBA should initiate a review. This recommendation was endorsed by the AHMC in 2007.
The aim of the Review is to identify improvements to the distribution arrangements for blood products by examining the current system, comparing it with best practice and identifying areas of improvement.
The Review should describe the current distribution system, and in doing so:
- consider the links between the approval process and distribution
- assess the costs, efficiency and effectiveness of the current system
- prepare a formal analysis of the supply chain requirements of different users
- assess risks in the current system and potential mitigation strategies
- quantify improvements that could be made in better achieving the objectives of the National Blood Agreement.
In undertaking the work of the Review and providing recommendations, the Review should also consider the potential for the number of stocking points and stock levels, inventory target levels and the adoption of multiple distribution channels to either positively or negatively contribute towards improving the current system.
The Review should identify an implementation strategy for any recommended improvements.
Progression of barcoding policy
In 2006–07, the JBC agreed to the national implementation of a barcode standard of ISBT 128 for all fresh blood products and GS1 128 (formerly EAN 128) for all plasma, recombinant and diagnostic products by 1 July 2011. Since that time the NBA has been consulting with jurisdictional representatives and the ARCBS in order to provide assistance in the implementation of the policy. Projects have now been developed to assist in the implementation, and during 2008–09 these will be trialled to inform the wider sector implementation plan
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