Federal Register of Legislation - Australian Government

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QAA 10/2016 Declarations/Other as made
This instrument declares the Australian Organ and Tissue Donation and Transplantation Authority: Australian Vigilance and Surveillance System for Organ Donation and Transplantation to be a quality assurance activity.
Administered by: Health
Registered 10 Oct 2016
Tabling HistoryDate
Tabled HR12-Oct-2016
Tabled Senate13-Oct-2016
To be repealed 05 Oct 2021
Repealed by Self Repealing

 

 

Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 10/2016

 

 

I, Brendan Murphy, delegate of the Minister for Health and Aged Care, make this declaration under section 124X of the Health Insurance Act 1973.

 

 

 

Dated:                 6th October 2016

 

 

 

 

 

 

 

Professor Brendan Murphy

Chief Medical Officer

Department of Health

 



Part 1          Preliminary

 

1.                       Name of Declaration

 

This Declaration is the Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 10/2016.

 

2.                       Commencement

 

This Declaration commences the day after registration.

 

3.                       Repeal of this instrument

 

This Declaration is repealed at the end of 5 years after it is signed.

 

4.                       Authority

 

This Declaration is made under the section 124X of the Health Insurance Act 1973.

 

5.                       Declaration of quality assurance activity

 

A quality assurance activity described in the Schedule to this Instrument is, to the extent the activity relates to health services provided in Australia, declared to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 applies.

 

 


Schedule

 

Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 10/2016

 

1          Title

Australian Vigilance and Surveillance System for Organ Donation and Transplantation

 

             Description:

 

The Australian Vigilance and Surveillance System for Organ Donation and Transplantation is the central national location for reporting Serious Adverse Events and Reactions (SAER) relating to organs from deceased donors and participants in the Australian Paired Kidney Exchange and is managed by the Australian Organ and Tissue Donation and Transplantation Authority.  The activity improves patient outcomes and management of transplantation by:

a)      monitoring, recording and analysing SAERs;

b)      assessing the impact of an intervention; and

c)      identifying trends in adverse events associated with organ donation and informing future clinical practice and supporting the identification of problems or shortcomings in the delivery of care.

The Australian Vigilance and Surveillance System for Organ Donation and Transplantation collects data through notification of SAERs.

Under the Australian Vigilance and Surveillance System for Organ Donation and Transplantation:

·         The Reporter, who is typically, but not limited to a member of the medical, nursing or laboratory staff associated with the donation, retrieval or transplantation of an organ, becomes aware of the SAER and initiates the notification to the State Medical Director;

·         The State Medical Director (or delegate) oversees the deceased donation process for consistency of practice within jurisdictions, completes preliminary assessments, reviews information provided by the Reporter against the Severity Grading and Imputability Grading and generates a Serious Adverse Event Notification form to inform the National Medical Director;

·         The National Medical Director (or delegate) is responsible for coordinating national communication and dissemination of information relating to a SAER as deemed necessary in conjunction with the State Medical Director and the Vigilance and Surveillance Expert Advisory Committee; and 

·         The Vigilance and Surveillance Expert Advisory Committee established by the Australian Organ and Tissue Donation and Transplantation Authority monitors the performance of the Australian Vigilance and Surveillance System for Organ Donation and Transplantation, recommend action to address non-compliance and risks, prepare submissions for international reporting, identify and recommend best practice and strategic intervention and formulate policy advice.