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To be repealed 05 Oct 2021
Repealed by Self Repealing

 

EXPLANATORY STATEMENT

ISSUED BY THE AUTHORITY OF THE MINISTER FOR HEALTH AND AGED CARE

HEALTH INSURANCE ACT 1973

DECLARATION OF QUALITY ASSURANCE ACTIVITY UNDER SECTION 124X OF THE HEALTH INSURANANCE ACT 1973 - QAA 10/2016

 

Part VC of the Health Insurance Act 1973 (the Act) creates a scheme to encourage efficient quality assurance activities.  Those activities help to ensure the quality of health services that are funded by the Government, including through Medicare benefits, the Pharmaceutical Benefits Scheme, and/or Health Program Grants.  The scheme encourages participation in such activities by protecting certain information from disclosure, and also by providing some protection from civil liability to certain persons engaged in those activities in good faith, in respect of those activities. 

In order for Part VC to apply to an activity, the Minister must make a declaration pursuant to section 124X of the Act, that the activity is a quality assurance activity to which Part VC applies. 

The Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 10/2016 (the Declaration) has effect from the day after registration on the Federal Register of Legislation.

The Declaration applies Part VC of the Act to the following activity, to the extent it relates to health services provided in Australia:

1.      Australian Organ and Tissue Donation and Transplantation Authority: Australian Vigilance and Surveillance System for Organ Donation and Transplantation

 

An overview of the activity is contained in Attachment A.

Before making a declaration under section 124X, the Minister must be satisfied that the persons engaged in the activity are authorised to do so in one of the ways set out in paragraph 124X(3)(a) of the Act.  The persons engaged in the Australian Vigilance and Surveillance System for Organ Donation and Transplantation are authorised to do so by the Australian Organ and Tissue Donation and Transplantation Authority which is a government authority(see subparagraph 124X(3)(a)(ii)).

 

Secondly, paragraph 124X (3)(b) of the Act provides that the Minister must be satisfied that it is in the public interest to have Part VC of the Act apply to the activity. In doing so, the Minister must have regard to criteria prescribed by regulation. The criteria are set out in regulations 23C to 23G of the Health Insurance Regulations 1975.

The activity meets the criteria as follows:

·         As required by regulation 23C, the activity includes the disclosure of non-identifying information that concerns the analysis of reported events. The Australian Vigilance and Surveillance System for Organ Donation and Transplantation develops annual activity reports based on Serious Adverse Events and Reactions data associated with organ donation and transplantation.  The report will include trends or key findings in relation to SAERs that occur in the process of organ donation and transplantation.

·         Regulation 23D does not apply as the Australian Vigilance and Surveillance System for Organ Donation and Transplantation will be undertaken in more than one State or Territory.

·         Regulation 23E applies as the Australian Vigilance and Surveillance System for Organ Donation and Transplantation has not previously been carried out in Australia.  The application of Part VC of the Act to the activity is necessary to make the activity effective as it encourages full participation by persons who provide health services through acceptance and implementation monitoring of recommendations.

·         Regulation 23F does not apply as the activity has not previously been engaged in Australia.

·         Regulation 23G does not apply as the Australian Vigilance and Surveillance System for Organ Donation and Transplantation will not include the assessment or evaluation by a person of the services, skill or performance of a health practitioner for the purpose of determining the health care practitioner’s clinical practicing rights.

 

CONSULTATION

An assessment of the application includes an assessment of the potential value of declaring the activity as a quality assurance activity for the purposes of the Act, the methodology used to conduct the activity, and whether the application meets the criteria required for declaration as set out in the Regulations.

The declaration of this activity will not result in any direct or substantial indirect effect on business.

The Declaration comes into operation on the day after registration on the Federal Register of Legislation.

Subsection 124X(4) of the Act provides that, unless sooner revoked, a declaration ceases to be in force at the end of 5 years after it was signed.  Accordingly, the Declaration provides that it is repealed at the end of 5 years after it is signed.

 

The Declaration is a legislative instrument for the purposes of the Legislation Act 2003.

 


 

ATTACHMENT A

OVERVIEW OF THE ACTIVITY

1.                  PURPOSE OF ACTIVITY

The Australian Organ and Tissue Donation and Transplantation Authority work with states and territories, clinicians and the community sector to deliver the Australian Government’s national reform programme to improve organ and tissue donation and transplantation in Australia.

 

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. 

 

The data collected from the activity supports the investigation, resolution and learning from SAER from organ donation and transplantation.  The Australian Vigilance and Surveillance System for Organ Donation and Transplantation, through the Vigilance and Surveillance Expert Advisory Committee, monitor adverse occurrences and provide advice on remedial action required, as well as any preventive and corrective measures to assist with quality improvements.

 

The objectives of the Australian vigilance and surveillance system for organ donation and transplantation are to:

·                     to provide a central point for the review and communication of information            pertaining to SAERs in organ donation and transplantation; and

·                     facilitate retrospective review and analysis of data resulting in de-identified           annual public reporting to inform clinical practice improvements for organ       donation and transplantation.


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

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

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the
Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 10/2016 (the Declaration) 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 to which Part VC of the Health Insurance Act 1973 (the Act) applies.  Information known solely as the result of the Australian Vigilance and Surveillance System for Organ Donation and Transplantation, or documents created solely for the purposes of the Australian Vigilance and Surveillance System for Organ Donation and Transplantation, will be covered by qualified privilege.

Human rights implications

This Declaration engages the right to health as set out in Article 12 of the International Covenant on Economic, Social and Cultural Right by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The Qualified Privilege Scheme established by Part VC of the Act is aimed at encouraging participation in quality assurance activities that help ensure the highest possible health care standards are maintained. The quality assurance activity described in this Declaration will provide participants with a greater degree of confidence and security that their participation is solely for the benefit of establishing and improving outcomes of the community health care.

Conclusion

This Declaration is compatible with human rights as it promotes the right to health.