EXPLANATORY STATEMENT
Issued by the authority of the Minister for Health and Ageing
AMENDEMENT DECLARATION OF QUALITY ASSURANCE ACTIVITY UNDER SECTION 124X OF THE HEALTH INSURANCE ACT 1973
QAA 2/2013
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, through Medicare benefits, the Pharmaceutical Benefits Scheme, Public Hospitals 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 or her delegate must make a Declaration pursuant to Section 124X of the Act, that the activity described in the Declaration is a quality assurance activity to which Part VC applies. Regulations 23C to 23G of the Health Insurance Regulations 1975 (the Regulations) set out the public interest criteria that must be met by quality assurance activities in order to be declared under section 124X.
This Declaration has effect from the day after registration on the Federal Register of Legislative Instruments. Section 124X(4) of the Act prescribes that, unless sooner revoked, this determination ceases to be in force at the end of 5 years after the instrument of Declaration was signed.
The purpose of QAA 2/2013 is to amend one quality assurance activity to include reporting of incidents from the Australian and New Zealand College of Anaesthetists (ANZCA). The activity to be amended is the Australasian and New Zealand Audit of Surgical Mortality (ANZASM) carried out by the Royal Australasian College of Surgeons (RACS). This activity was previously declared in QAA 4/2011. The ANZASM is a framework of regionally based mortality audits designed to provide an external peer review of surgically related deaths. Through the process of audit, the analysis of collected data may potentially identify clinical events, system and process errors and trends which may impact upon the safety and quality of surgical care. The information is disseminated by publication of reports on de-identified aggregated data.
Before the Minister or her delegate can make a Declaration, certain requirements must be met.
Firstly, the Minister or her delegate must be satisfied that the persons engaged in the activity are authorised to do so as described in paragraph 124X(3)(a) of the Act. The ANZASM including the new amendment meets the requirement as the persons engaged in the activity are authorised either by an association of health professionals.
Secondly, paragraph 124X(3)(b) of the Act provides that the Minister or her delegate 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 or her delegate must have regard to criteria prescribed by the Regulations. The criteria relevant to the activity are in regulations 23C, 23D and 23E or 23F and 23G. The activity including the amendment, meets the relevant criteria prescribed by the Regulations.
CONSULTATION
Consultations regarding the application for amendment to a Declaration were undertaken in April 2013. This included obtaining advice on the potential value of declaring the amendment to 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, in particular those criteria relating to whether it is in the public interest to declare the activity.
Those consulted included members of the Qualified Privilege Advisory Group, which includes: an external clinician; a legal expert; a quality manager working in the field of health care quality assurance; and a consumer representative.
The Declaration of the activity will not result in any direct or substantial indirect effect on business.
This Amendment Declaration commences the day after registration on the Federal Register of Legislative Instruments and unless sooner revoked will cease on the day of cessation of QAA 4/2011.
The Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The Quality Assurance Activity Amendment Declaration 2013 (QAA 2/2013) was introduced to address the need for updated quality assurance activities within the framework established by the Health Insurance Act 1973. Enacted by the Minister for Health and Ageing, this amendment seeks to enhance the quality and safety of health services funded by the government, including Medicare benefits, the Pharmaceutical Benefits Scheme, and public hospitals, by modifying the existing Australasian and New Zealand Audit of Surgical Mortality (ANZASM) to include the reporting of incidents from the Australian and New Zealand College of Anaesthetists (ANZCA). This legislative instrument aims to ensure that quality assurance activities are conducted in the public interest, providing necessary protections from disclosure and civil liability for participants acting in good faith. The policy objective is to foster a culture of continuous improvement in healthcare quality through rigorous, transparent, and externally reviewed audit processes.
Scope and Application
The QAA 2/2013 Amendment Declaration pertains to the Health Insurance Act 1973, specifically amending the quality assurance activity known as the Australasian and New Zealand Audit of Surgical Mortality (ANZASM) carried out by the Royal Australasian College of Surgeons (RACS). The Act applies to the activity of auditing surgical-related deaths, which involves the collection and analysis of data to identify potential clinical events, system, and process errors that may impact the safety and quality of surgical care. This amendment includes reporting of incidents from the Australian and New Zealand College of Anaesthetists (ANZCA). The geographic reach of the Act is national, as it pertains to health services funded by the Government through Medicare benefits, the Pharmaceutical Benefits Scheme, Public Hospitals, and Health Program Grants. The activity is protected from disclosure and civil liability under the scheme, provided it meets the criteria set out in the Regulations. The Minister or their delegate must be satisfied that the persons engaged in the activity are authorised and that it is in the public interest, considering the criteria prescribed by the Health Insurance Regulations 1975. The Declaration has been subjected to consultation, ensuring the activity aligns with the public interest criteria and the overall intent of the Act.
Key Provisions
The main operative sections of this legislation, specifically the Amendment Declaration of Quality Assurance Activity under Section 124X of the Health Insurance Act 1973 (the Act), pertain to the modification of an existing quality assurance activity. The amendment, detailed in QAA 2/2013, focuses on the Australasian and New Zealand Audit of Surgical Mortality (ANZASM) carried out by the Royal Australasian College of Surgeons (RACS). This activity, previously declared under QAA 4/2011, now includes the reporting of incidents from the Australian and New Zealand College of Anaesthetists (ANZCA). The purpose of this amendment is to enhance the scope of the audit to better address safety and quality issues in surgical care through the identification and analysis of clinical events and system errors. The activity operates by collecting de-identified aggregated data and publishing reports to disseminate findings (Section 124X(4)).
The obligations and requirements imposed by the Act on the parties or entities governed by it are primarily centred around the authorisation of individuals involved in the quality assurance activity and the public interest criteria that must be met. According to Section 124X(3)(a) of the Act, the Minister or her delegate must be satisfied that the persons engaged in the activity are authorised to do so. For the ANZASM, this requirement is met as the individuals involved are authorised by an association of health professionals. Additionally, under Section 124X(3)(b), the Minister must be satisfied that it is in the public interest to have Part VC of the Act apply to the activity. This determination must consider the criteria prescribed by the Health Insurance Regulations 1975, specifically regulations 23C, 23D, 23E, 23F, and 23G. The ANZASM, including the amendment, meets these prescribed criteria, ensuring that the activity aligns with public interest considerations.
In terms of offences, penalties, or civil/criminal consequences for breach, the Act does not explicitly detail specific penalties for non-compliance with the quality assurance activity requirements. However, the overarching legislative framework and the Health Insurance Act 1973 may provide for various enforcement mechanisms, including the potential for administrative actions, fines, or other sanctions for non-compliance with health-related regulations. The precise consequences for breach would depend on the specific context and applicable laws, but the primary focus of the legislation is on ensuring the quality and safety of health services through authorised and public interest-aligned activities. The Declaration itself, which has effect from the day after registration on the Federal Register of Legislative Instruments, will cease to be in force at the end of 5 years after the instrument of Declaration was signed unless revoked sooner (Section 124X(4)).