National Blood Authority Australia

Annual Report 2010–11

Part 5: Performance: Supporting Appropriate and Safe Use of Bloof and Blood Products

CLINICAL GOVERNANCE AND DATA SYSTEMS

The NBA is devoting considerable resources to the development and establishment of data and governance systems that are nationally consistent, generate robust quantitative information and provide sound decision-making functions to support and maintain sector improvements.

Many of these strategies are described in Part 4 of this report (see pages 62-79). Here we give details of several other data and governance initiatives which are more clinically-oriented.

Red blood cell usage project

The purpose of the red blood cell usage project is to facilitate jurisdictional-based data linkage with the aim of producing a nationally consistent data set of, and ultimately a national report on, use and the appropriateness of use of blood and blood products in Australia. To date the blood sector has largely lacked data at a national level which can be used to guide options for improvements.

The initial commitment to obtaining data on red blood cell usage began at the national level in 2009 when the NBA coordinated a workshop to determine an ideal minimum data set for recording red blood cell usage in Australia. The first data set, representing some comparative red cell, platelet and FFP utilisation data, had been published by Trevor Cobain in the mid-2000s using Western Australia hospital data. Since that time NSW, SA, WA and Queensland have advanced their data linkage capabilities and the resulting data and analyses are being used to influence clinical practice. The project was given additional impetus at the CTEPC Blood Policy Forum held in March 2011, at which participants considered examples of the types of data being generated by the WA PBM Program.

A workshop was held in August 2011 to finalise the methodology for jurisdictional data linkage specific to blood and blood products. The data elements will be a combination of selected core clinical and demographic elements which will provide information, for example, on patterns of use of red blood cells. We have continued to work on the collection, aggregation and analyses of this new national data set.

We anticipate that the same data linkage methodology could be used to capture existing data on all other blood and blood products recorded in hospital and pathology systems.

Haemovigilance

The transfusion of blood and blood products is a core component for healthcare service delivery to patients. However, the transfusion of blood products is not without risk and can lead to complications. The monitoring of serious adverse events resulting from transfusion is critical to transfusion safety. The systems and processes for monitoring are known as haemovigilance systems.

The World Health Organization Global Database on Blood Safety Report 2004-05 indicated that 42 of 105 reporting countries had a national haemovigilance system in place and 24 were in the process of developing one. The 2008 report indicates that 57 of 106 reporting countries have implemented a national haemovigilance system.

Working within the NBA's Haemovigilance Program, the Haemovigilance Advisory Committee (HAC), established in 2009, contributes to improving patient outcomes by providing enhanced, nationally consistent reporting on transfusion-related adverse events at a national level.

During the year the HAC developed an outline of a consensus guideline on the recognition and management of acute transfusion reactions and events. The NBA anticipates developing this document in 2013 in collaboration with external experts.

The composition and functions of the HAC has changed significantly during the year:

  • in addition to fresh blood products, future Australian haemovigilance reports will include information on adverse events associated with clotting factors and other blood products. This data has become available as a result of the redevelopment of the ABDR as a module of BloodNet and after reaching agreement with the AHCDO
  • the committee will give more guidance on the direction, priorities and activities to reduce adverse events, including for clotting factors and other non-fresh blood products
  • the membership of the committee will be adjusted to include expertise on clotting factors and issues relevant to the haemophilia community.

The next biennial Australian Haemovigilance Report will be published during 2012-13.

Clinical governance of IVIg

The group responsible for the review of the Criteria identified the following issues during the review process:

  • significant variations in prescribing practice for some clinical indications
  • insufficient evidence for many indications
  • insufficient quality research evidence in relation to dosing, in particular adjusted body weight dosing and dose requirements for subcutaneous administration
  • a national governance strategy to manage requests for indications not currently listed in the Criteria
  • emerging indications in the literature that may have a significant impact, e.g. Alzheimer's disease (see pages 70, 73 and 75)
  • the management approach for managing subcutaneous and normal immunoglobulins under the Criteria.

We have recognised the value of this expert advice from the working group, and the JBC has approved the establishment of an NBA immunoglobulin clinical advisory committee. In addition to responding to clinical queries arising during the transition to the second edition of the Criteria, this committee will also provide expert clinical input to the review of the authorisation and clinical governance framework for IVIg (see pages 76-77).