3.5 Blood Counts

The Blood Counts Program aims to collaborate with jurisdictions, health professionals and other stakeholders to improve patient outcomes through the appropriate utilisation of blood and blood-related products.

The Blood Counts Program comprises a number of projects divided into streams that reflect the safety and quality intent of the National Blood Agreement. Specific projects have been selected after consideration by the NBA Clinical Advisory Council, the professional and community forum, JBC priorities and other key stakeholders.

Stream 1 — Development, implementation and promotion of best practice guidelines and standards

Criteria for the Clinical Use of Intravenous Immunoglobulin (IVIg) in Australia

The growth in demand for IVIg, (Figure 3.8) the relatively high cost and the potential for supply shortages, prompted action by Australian governments to ensure that IVIg use  is reserved for those with the greatest need.

The Criteria for the Clinical Use of Intravenous Immunoglobulin (IVIg) in Australia (the Criteria), published in March 2008, was developed under guidance of a JBC Working Party with funding and project management provided by the NBA. The review process, conducted between 2004 and 2006, involved two systematic reviews of the evidence, a review of use of the product in Australia and extensive consultation with the clinical community through the invitation of written submissions and two national workshops.

The Criteria identifies the conditions and circumstances as found by the evidence and recommended by experts for IVIg therapy. The Criteria has four introductory chapters covering governance arrangements, production of IVIg, supply and demand, and the methodology used to develop the Criteria. Chapters 5–8 of the publication provide clinical information for each indication considered in the review process. Indications are allocated to chapters according to therapeutic use as follows:

After JBC endorsement of the Criteria and the associated funding policy statement in May 2007, the Criteria was progressively endorsed by the Clinical, Technical Ethical Principal Committee (CTEPC), the AHMAC and then Health Ministers at the AHMC in December 2007.

A communications strategy was devised in collaboration with the ARCBS and other key clinical stakeholders and implemented during February and March 2008. This was to ensure that all relevant stakeholders including hospitals, colleges, societies and key individuals were aware of, be provided with or could easily obtain a copy of the Criteria.

The Criteria was published in full as a book and also in an abbreviated form as a Quick Reference Guide. Both were published in hard copy and various electronic formats to create flexible access and modes of use. Copies can be requested or downloaded from the NBA website free of charge.

Between March and June 2008, 4594 full Criteria and 4658 Quick Reference Guides have been distributed including those downloaded from our website and those hardcopies ordered. The NBA will continue to monitor product use against these criteria and note any demand for changes to the Criteria arising from new clinical evidence of benefit for consideration as part of the review of the Criteria in 2010.

The top ten uses of IVIg in Australia as detailed in Figure 3.17 account for 74.6% of total use.

The NBA established a process endorsed by the JBC to respond to questions arising from the implementation of the Criteria. The purpose of the process is to provide nationally consistent interpretations of any diagnostic, qualifying, exclusion or review criteria published in Chapters 5, 6 or 7 of the Criteria where ambiguities have arisen or are considered likely to arise.

The process will be managed via email through an NBA secretariat. Issues will be submitted to a consultation group for comment. The comments will be collated by the secretariat and then submitted to a resolution group for decision. Where decisions have no impact on the supply plan, they will be promulgated through the consultation group. Where there is a potential to impact in a material way on supply, JBC endorsement is required prior to promulgation.

Figure 3.16 Criteria for the Clinical Use of Intravenous Immunoglobulin (IVIg) in Australia: book and Quick Reference Guide

Figure 3.16 Criteria for the Clinical Use of Intravenous Immunoglobulin (IVIg) in Australia: book and Quick Reference Guide

Figure 3.17 Top ten uses of intravenous immunoglobulin (IVIg)

Figure 3.17 Top ten uses of intravenous immunoglobulin (IVIg)



We’d like to introduce you to Sam – Sam is a normal 11 year old boy who loves to be outside kicking a soccer ball with his Dad or fishing and catching crabs in the Queensland sunshine. But Sam is also one of more than 500 Australians who have common variable immune deficiency or CVID for short.

Picture: Sam is a normal 11 year old boyCVID is one of a group of diseases which affect the immune system and mean that the person is very susceptible to infections. Thankfully there is a treatment which can help with CVID and other immuno-deficiency diseases – intravenous immunoglobulin (IVIg). IVIg is a product that is derived from blood plasma. It is a solution of globulins containing antibodies normally present in adult human blood that provides immunity against disease. IVIg is prepared from human plasma pooled from many donors which has undergone stringent screening and testing to ensure it is safe. IVIg must be administered slowly through a needle in the vein, so once a month Sam spends 6 hours at the hospital getting his treatment. It’s not fun but Sam doesn’t mind too much as the nurses are really nice and he gets to play with the ‘purple egg’ (computer games).

No-one knows why or how people like Sam develop CVID. Tracy, Sam’s Mum, says that Sam was a sick toddler; ‘He got lots and lots of infections. He got pneumonia and meningitis. Where the other kids got the normal bugs and viruses, Sam would end up in hospital with all sorts of unusual symptoms’. Finally Tracy asked her doctor if there could be some underlying cause for all Sam’s infections and, after lots of tests, he was diagnosed with CVID and started on IVIg.

Whilst Tracy and Sam’s Dad Rob were relieved to finally have a treatment for Sam, they also found it somewhat daunting to be confronted with a diagnosis for their son of a condition that would probably require long term use of intravenous infusions in a hospital setting. Like most people, Tracy and Rob had never heard of CVID or immune deficiency diseases and they are very grateful for the education and support they have had from the Immune Deficiencies Foundation of Australia (IDFA).

IDFA is a non-profit organisation dedicated to supporting children, teenagers and adults with diagnosed primary immune deficiency (PID) disorders and has a strong focus on education for both the public and medical professionals.

For Sam and his family, having IVIg means that Sam is a normal healthy kid who gets on with school and loves to play soccer, cricket and go swimming. Without IVIg he is very susceptible to infections, is chronically tired and consequently, his behaviour and his schooling suffers. ‘Having IVIg has made a huge difference to Sam, without it he is so tired that he can’t concentrate at school, to the point where the teachers tell me he lies on the floor or puts his head on his desk to go to sleep. Because he is so tired, he is irritable and not tolerant of others’. With IVIg treatment Sam is a happy, energetic boy who can do all the things other boys his age do.

Review of National Health and Medical Research Council and Australasian Society of Blood Transfusion guidelines

The Clinical Practice Guidelines on the Use of Blood Components (2001) were jointly developed by the National Health and Medical Research Council (NHMRC) and the then Australasian Society of Blood Transfusion, in cooperation with the Australian Government Department of Health and Ageing, the Royal Australasian College of Surgeons, the Australian and New Zealand College of Anaesthetists and other relevant groups. The Guidelines focused on the clinical decision to transfuse and the supporting quality processes. Their aim was to improve transfusion practice by:

Significant new clinical and scientific data have emerged since the 2001 Guidelines were developed. Omitting important areas of practice (specifically obstetrics and paediatrics) was acknowledged at the time of publication of the Guidelines and a review of the Guidelines will provide an opportunity to include these areas. In addition, critical bleeding scenarios, haemodynamically unstable patients and chronic transfusion recipients (especially haematology-oncology patients) have been identified as other important gaps in coverage.

During the year, a review of the Guidelines commenced. The aim of the review is to develop evidence-based recommendations to guide health practitioners in effectively managing patients who require blood management intervention. The review will achieve this aim through:

A multitiered management framework has been established to coordinate the review. The framework consists of an overarching steering committee chaired by the NBA and with representation from the Australian and New Zealand Society of Blood Transfusion (ANZSBT), the NHMRC and the National Institute of Clinical Studies. An expert working group (EWG), chaired by the ANZSBT will oversee the clinical aspects of guideline procedures, including gaining input from a number of clinical reference groups. These will provide expertise on specific elements of the new Guidelines. Engagement of clinical users of blood products in the review process will assist with acceptance and implementation of the Guidelines.

A Guidelines Assessment Register (GAR) expert appointed by the NHMRC will provide advice and mentoring to the EWG. This will ensure the new Guidelines and the development process complies with NHMRC requirements.

It is anticipated that the systematic reviewer and guideline writer will be appointed soon after the initial meeting of the EWG, which is planned early in the 2008–09 financial year.

Consultation with the clinical community at several national meetings to date has strongly endorsed a shift from the current product focus of the existing Guidelines to one that focuses more on managing the patient’s particular condition. In addition, the place of alternative therapies in managing patients who would otherwise have required transfusion is also of significant interest to clinicians and will form part of the review process.

Stream 2 — Facilitation of education, information sharing and practice improvement initiatives

Sharing a South Australian e-learning initiative

In Australia, mandatory accreditation of hospitals now includes specific requirements related to transfusion. Hospital policies, practice and systems are assessed against defined criteria that include the collection and labelling of specimens, administration of the blood component, appropriate prescribing and decision making, quality improvement and education.3

In 2006 the South Australia Department of Health funded the development of an online education package (e-learning) for clinical staff involved with the transfusion chain, including medical officers, nurses and midwives, and courier or porter staff that transport blood products.4

This e-learning tool has been successfully used within South Australia and significant interest has been expressed by other states and territories (and internationally). This interest led the NBA to work with South Australia Health to propose the assessment and development of appropriate governance arrangements to enable this tool to become a sustainable national tool. The project to determine these arrangements will commence from 1 July 2008.

Stream 3 — Improvements to systems

Publication of the Initial Australian Haemovigilance Report

In February 2008, the NBA published the Initial Australian Haemovigilance Report (see Figure 3.18) under the expert guidance and support of the National Haemovigilance Project Working Group and was subsequently endorsed by the JBC.

Figure 3.18 Initial Australian Haemovigilance Report

Figure 3.18 Initial Australian Haemovigilance Report

The Report outlines jurisdictional progress towards achieving improvements in transfusion safety through increased systems of vigilance and improved transfusion safety practices.

The Report also provides a synopsis of available jurisdictional and national data. Although there were variations in reporting periods and definitions, the broad types of transfusion risks in Australia were found to be similar to those of other countries that report transfusion adverse events, such as the United Kingdom, New Zealand, Sweden and Canada. A key observation relating to the more than 600 transfusion-related incidents reported over the past 3–5 years in Australia was that approximately 65% of reports involved procedural errors. These included patient misidentification, labelling errors, wrong blood in tube, prescription and dispensing errors, incorrect blood component transfused and ABO incompatibilities.

The Report makes the following recommendations:

In recognition of the prevalence of procedural errors, the Report recommended that state and territory governments consider:

The NBA is committed to facilitating the achievement of these recommendations in the coming years.

Stream 4 — Research, data and benchmarking to improve appropriate use of products

National Red Cell Utilisation Workshop

On 18 April 2008, the NBA conducted a National Red Cell Utilisation Workshop. The aim of the workshop was to facilitate sharing of existing data on current red cell use, to improve understanding of current red cell use and data collection methodology (including limitations).

Representatives from five jurisdictions and the ARCBS presented the methods and results of the investigations conducted into red cell use.

Table 3.8 outlines the five broad approaches used to look at red cell use in a range of jurisdictions.

Table 3.8 Types of red cell usage studies being undertaken within the states and territories

Model type Methodology
Red cell survey A random sample survey of red cell units considered the urgency of the transfusion, transfusion demographics and the clinical indication for usage.
Red cell audit Undertook a paper-based audit process that assessed red cell utilisation against the 2001 Guidelines, for randomly selected patients.
Data linkage A number of jurisdictions have undertaken data linkage processes that used information from various sources such as hospital records, pathology information and ARCBS data, allowing individual patient requirements to be cross-matched. These types of processes created rich data source that allows a variety of analysis to be undertaken.
Databases Data was collected based on the guidelines and clinical information provided at the time of request for red cells. This database provides the ability to then report the information collected.
Market research Interviews were conducted with 21 surgeons and registrars in various specialities (cardiac, orthopaedic, gastroenterology and anaesthetics) and split between rural and metropolitan areas, based on their perceptions and decision making with respect to blood transfusion.

Each of these models provides a varying degree of information about red cell use within Australia.

Red cells were found to be prescribed in a highly variable way across and within individual institutions, states and jurisdictions. Some institutions had much less variation in red cell prescribing than others. On investigation, these sites were found to have well-developed systems to inform and control blood prescribing practices. Highest volume use was found in cardiovascular, gastroenterology and haematological (malignant and nonmalignant).

Some key highlights from the data presented include:

A round table discussion was held after the presentations that led the group to propose a number of recommendations for the NBA’s consideration as a part of its broader work program. The NBA has committed to developing a multifaceted strategy, in collaboration with key participants at this meeting, to underpin improvements to red cell prescribing practices.

Market research into red cell prescribing practices for haemodynamically stable patients

Although red blood cell transfusions are an important part of the treatment of some haemodynamically stable patients, there is evidence to suggest that a number of transfusions in such settings are inappropriate. Some patients are being exposed unnecessarily to the risks associated with transfusion. The NBA and the Clinical Excellence Commission in New South Wales jointly funded market research to inform the development of state and national communications strategies. These will aim to enhance prescriber compliance with the NHMRC and ASBT guidelines on the use of blood components and to reduce the number of unnecessary or inappropriate prescriptions for red blood cell transfusions.

In summary, the research reached six conclusions:

In light of the above findings, in May 2008 the New South Wales Clinical Excellence Commission and the NBA agreed to co-fund further research to develop communications strategies and key messages to enhance appropriate prescribing of blood for haemodynamically stable patients.

Blood Measures — a collaborative project between the National Blood Authority and the Australian Red Cross Blood Service

Despite a number of clinical practice guidelines regarding blood transfusion, there is still wide variation in use, both internationally and domestically, within countries, regions and even within hospitals. Learning about the variation in use is vital to understanding clinical demand and therefore ensuring supply. Within Australia, there have been a number of separate initiatives to investigate product use; however, each of these projects has developed independently with different motivations, aims, methodologies and outcomes. Comparison between outcomes of these projects is difficult due to the differences in data types, definitions and methodologies.

Blood Measures aims to achieve widespread use by those involved in the collection of blood use data by:

Chaired by Professor James Isbister (consultant in haematology and transfusion medicine), and with participants coming from a wide range of clinical backgrounds, the National Blood Measures Working Group is developing a national guide outlining suggested standard measures and definitions which can be used in any study of blood and blood-related products.

3 Australian Council on Healthcare Standards (ACHS): Standards and criteria for the Evaluation and Quality Improvement Program Version 4 (EQuIP 4). 2007 Accessible online at http://www.achs.org.au

4 Available for viewing online at http://www.bloodsafelearning.org.au


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