Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 7/2016

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01235 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

ISSUED BY THE AUTHORITY OF THE MINISTER FOR HEALTH

HEALTH INSURANCE ACT 1973

DECLARATION OF QUALITY ASSURANCE ACTIVITY UNDER SECTION 124X OF THE HEALTH INSURANCE ACT 1973 - QAA 7/2016

 

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 of the Act 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 7/2016 (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:

 

  1. Royal Australasian College of Surgeons (RACS): Australian and New Zealand Audits of Surgical Mortality (ANZASM)

 

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 engaging 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 ANZASM are authorised to do so by RACS, which is an association of health professionals and an educational institution (see subparagraphs 124X(3)(a)(vi) and (iv)).

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 relevant to the activity are in regulations 23C to 23G of the Health Insurance Regulations 1975 (the Regulations).

The ANZASM meets the criteria as follows:

  • As required by regulation 23C, the activity includes the disclosure of non-identifying information that concerns the quality of service assessed, evaluated or studied. This non-identifying data will be used in peer review and self-reflective components disseminated to health practitioners, hospitals and departments of health.
  • Regulation 23D does not apply as the activity will be undertaken in more than one State or Territory.
  • Regulation 23E does not apply as the activity has previously been engaged in Australia.
  • Regulation 23F applies as the activity has previously been carried out in Australia. The Minister’s declaration will encourage greater participation in the activity by persons who provide health services by providing participants with a greater degree of confidence and security that their participation is solely to the benefit of establishing and improving quality assurance.
  • Regulation 23G does not apply as the activity 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

 

The ANZASM was previously declared to be quality assurance activity under section 124X of the Act (see Declaration of Quality Assurance Activity QAA 4/2011). ANZASM applied to continue the declaration of their activity as a quality assurance activity to which Part VC applies.

 

An assessment of the application included 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 met 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 and New Zealand Audits of Surgical Mortality (ANZASM) is an audit that records medical practitioners who perform surgical operations and have patient mortality occur under their care.  The audit includes all deaths which occur in a hospital when the patient was under the care of a surgeon (surgical admission) whether or not an operation was performed or the patient was under the care of a physician (medical and non-surgical admission) and where there was surgical input.

 

The reports will be used for peer to peer feedback which involves:

  • A self-reflection by the reporting surgeon and /or anaesthetist
  • A review of the patient notes by an appointed surgeon/anaeasthetist or committee of surgeons/anaesthetists
  • The preparation of a report to the reporting surgeon or anaesthetist

 

ANZASM is a group of regionally based surgical patient mortality audits. The regional audits in each jurisdiction other than New South Wales comes under the governance of ANZASM (managed by the Royal Australasian of Surgeons) and follows the ANZASM process.  The New South Wales regional audit is governed by the Clinical Excellence Commission and co-managed by the Clinical Excellence Commission and the Royal Australasian College of Surgeons.

 

This assessment is a mandatory component of the Royal Australasian College of Surgeons Continuing Professional Development Scheme.

 

The objectives of the activity are to:

  • Provide peer to peer feedback on factors involved in surgical patient mortality
  • Collect data on the factors involved in surgical patients mortality and,
  • Report upon the collected data to the health system including surgeons, hospitals, health departments and the public.


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 7/2016

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 7/2013 (the Declaration) declares the Australian and New Zealand Audits of Surgical Mortality (ANZASM) to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 (the Act) applies.  Part VC establishes a scheme to encourage efficient quality assurance activities. Information known solely as a result of the ANZASM, or documents created solely for the purpose of the ANZASM, will be covered by qualified privilege.

Human rights implications

The Declaration engages the right to health as set out in Article 12 of the International Covenant on Economic, Social and Cultural Right (ICESCR) 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 is aimed at encouraging participation in quality assurance activities that help ensure the highest possible health care standards are maintained. The quality assurance activities described in this Declaration will provide participants with a great 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.

 

Overview

The Declaration of Quality Assurance Activity under Section 124X of the Health Insurance Act 1973 - QAA 7/2016 was introduced to encourage efficient quality assurance activities within the health sector, particularly focusing on ensuring the quality of health services funded by the government, such as through Medicare benefits, the Pharmaceutical Benefits Scheme, and Health Program Grants. This legislative instrument, issued by the authority of the Minister for Health, applies Part VC of the Health Insurance Act 1973 to the Australian and New Zealand Audits of Surgical Mortality (ANZASM), which are conducted by the Royal Australasian College of Surgeons (RACS). The declaration aims to protect certain information from disclosure and provide some protection from civil liability to those engaged in the activity in good faith, thereby encouraging greater participation in quality assurance activities. The policy objective is to enhance the quality of health services by facilitating peer reviews and self-reflective practices among health practitioners, thereby promoting better health outcomes and the highest attainable standard of physical and mental health as recognised in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 7/2016 applies Part VC of the Act to the Australian and New Zealand Audits of Surgical Mortality (ANZASM) undertaken by the Royal Australasian College of Surgeons (RACS). This declaration serves to protect certain information from disclosure and provides some protection from civil liability to certain persons engaged in these activities in good faith. The declaration applies to the activity conducted by RACS, which is authorised as an association of health professionals and an educational institution. The Minister for Health must be satisfied that it is in the public interest to have Part VC of the Act apply to the ANZASM, which meets specific criteria outlined in the Health Insurance Regulations 1975. The declaration aims to encourage greater participation in quality assurance activities by offering participants confidence and security, ultimately benefiting the community health care system. The declaration is effective from the day after its registration on the Federal Register of Legislation and will remain in force for five years unless revoked sooner.

Key Provisions

The key operative sections of the Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 7/2016 (the Declaration) include section 124X, which authorises the Minister for Health to declare activities that qualify as quality assurance activities, and Part VC, which applies to these declared activities (section 124X(1)). Section 124X(3) outlines the criteria the Minister must be satisfied with before making a declaration, including that the persons engaging in the activity are authorised to do so, and that it is in the public interest for Part VC of the Act to apply to the activity (section 124X(3)(a) and (b)). The Declaration specifically applies Part VC to the Australian and New Zealand Audits of Surgical Mortality (ANZASM) (section 124X(1)). The obligations and requirements imposed by the Declaration on the parties it governs primarily include ensuring that the ANZASM activity adheres to the criteria set out in the Health Insurance Regulations 1975, particularly regulations 23C to 23G. The ANZASM must involve the disclosure of non-identifying information concerning the quality of services assessed, evaluated, or studied (regulation 23C). Moreover, the activity must have been previously carried out in Australia (regulation 23F), and it should not involve the assessment or evaluation of health practitioners for the purpose of determining their clinical practicing rights (regulation 23G). The Minister’s declaration aims to encourage participation in ANZASM by providing participants with confidence and security that their involvement is for the sole benefit of improving health care quality. Any breaches of the requirements or obligations under the Health Insurance Act 1973, particularly as they pertain to the ANZASM activity, could result in civil or criminal consequences. While the explanatory statement does not detail specific offences or penalties, breaches of similar provisions in the Act generally incur penalties that may include fines and, in severe cases, imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as any relevant provisions in the Act and related regulations. The Declaration itself notes that it will cease to be in force at the end of five years unless sooner revoked, and it is repealed at the end of this period (subsection 124X(4)).

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.