Latest online version of the Criteria
During the BloodSTAR transition period (July to December 2016), the addition of ‘new’ Criteria ‘evidence items’ fields does not change the basis for approval of authorisation of Ig product. Authorisers will evaluate authorisation requests with the same approach that applies to authorisation based on the use of previous paper forms. The Criteria (Second Edition) for states not yet transitioned to BloodSTAR.
From July 2016, the national roll out of BloodSTAR will commence using a staggered jurisdictional approach. This means a move away from paper based request forms to using the online BloodSTAR system. During the transition period (July to December 2016) it is important to use the process approved in your state.
Rollout start dates
The BloodSTAR go live dates can be seen in the figure below.
Has BloodSTAR now rolled out in your state or territory?
BloodSTAR is now effective in Northern Territory from 14 July. Please follow the link below to access BloodSTAR to request Immunoglobulin products.
Still waiting for rollout in your state or territory?
For all states other than Northern Territory and not yet using BloodSTAR, the following forms must be completed for each patient who requires access to Ig products:
- Authorisation Request forms (IVIg forms and SCIg forms) must be completed for each patient. The forms are two pages and both pages need to be completed and submitted to the Authoriser for assessment.
- Prescriber Acknowledgement and Confirmation is required to confirm that the patient has provided their explicit written or oral consent to:
- treatment access conditions and the provision of information to support authorisation and continuing therapy,
- the nature of ongoing monitoring and review of treatment clinical benefit and that access to product will cease if response to treatment does not demonstrate an adequate clinical benefit, and
- the collection, retention and use of personal sensitive data for the purposes of authorisation for initial and ongoing therapy, in accordance with the introduction of the Australian Privacy Principles.
For more information about BloodSTAR
Visit BloodSTAR for more information and resource materials about BloodSTAR.
Information is available for patients and to support clinicians with the conversation they have with patients around their treatment with immunoglobulin (Ig) products.
There are two product specific patient information brochures. One brochure covers information on Ig treatment and the other brochure is specific to subcutaneous Ig (SCIg) treatment.
The Prescriber acknowledgement and confirmation regarding patient consent is to be completed by the treating medical specialist or appropriate delegate following discussion with their patient and provided to the Australian Red Cross Blood Service. The form has two sides, only one or the other needs to be filled out. The form allows the prescriber to acknowledge:
• that they understand the governance and management arrangements for the appropriate supply and use of immunoglobulin products, funded under the national blood arrangements, and that they have provided the information required to support authorisation.
• That they have provided and/or explained to their patient (or parent/carer/guardian) the Privacy Statement and Notice (Notice) and Patient Information Brochure and given them the opportunity to ask questions.
- Prescriber acknowledgement and confirmation - patient consent (pdf) (118.74 KB)
- Prescriber acknowledgement and confirmation - patient consent (docx) (77.58 KB)
Privacy Statement and Notice
The Privacy Statement and Notice explains how the National Blood Authority manages personal and sensitive information it collects about patients and has been developed to support the consent process. Information about privacy and BloodSTAR can be found here.