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

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:                 6^th October 2016

Professor Brendan Murphy
Chief Medical Officer
Department of Health

Contents

PART 1           PRELIMINARY3

1            Name of Declaration3

2.           Commencement3

3.           Repeal of this instrument3

4.           Authority3

5.           Schedule   3

SCHEDULE    4

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.

1. Commencement

This Declaration commences the day after registration.

1. Repeal of this instrument

This Declaration is repealed at the end of 5 years after it is signed.

1. Authority

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

1. 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.