EXPLANATORY STATEMENT
Issued by the authority of the Minister for Health
AMENDEMENT DECLARATION OF QUALITY ASSURANCE ACTIVITY UNDER SECTION 124X OF THE HEALTH INSURANCE ACT 1973
QAA 4/2012
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 4/2012 is to amend one quality assurance activity to include reporting of incidents from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the Royal Australian and New Zealand College of Ophthalmologists (RANZCO). 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 Declaration were undertaken in March and July 2012. This included obtaining advice on 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, 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 F2012L01917 Amendment Declaration of Quality Assurance Activity under Section 124X of the Health Insurance Act 1973 (HIA) was introduced to address the need for the Australasian and New Zealand Audit of Surgical Mortality (ANZASM) to include incident reporting from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the Royal Australian and New Zealand College of Ophthalmologists (RANZCO). This amendment was aimed at enhancing the quality assurance activities by expanding the scope of the ANZASM, which is conducted by the Royal Australasian College of Surgeons (RACS), to include the collection and analysis of surgical mortality data from additional medical colleges. The enactment of this amendment was authorised by the Minister for Health and was enacted to ensure that the amended ANZASM would meet the criteria for being declared a quality assurance activity under Part VC of the HIA. The policy objective behind this amendment is to foster continuous improvement in the quality and safety of surgical care by providing a more comprehensive analysis of surgical-related deaths and identifying potential areas for improvement in clinical practice and healthcare processes. The declaration was made after consultations in March and July 2012, involving relevant stakeholders such as clinicians, legal experts, quality managers, and consumer representatives, to ensure the activity met the necessary public interest criteria and legislative requirements.
Scope and Application
The F2012L01917 Amendment Declaration of Quality Assurance Activity under Section 124X of the Health Insurance Act 1973 (the Act) pertains to the amendment of a previously declared quality assurance activity, specifically the Australasian and New Zealand Audit of Surgical Mortality (ANZASM) conducted by the Royal Australasian College of Surgeons (RACS). The amendment involves the inclusion of incident reporting from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the Royal Australian and New Zealand College of Ophthalmologists (RANZCO). The Act applies to the individuals and entities engaged in the ANZASM, particularly those authorised by an association of health professionals, and their activities of conducting external peer reviews of surgically related deaths to identify potential clinical events and system errors impacting the safety and quality of surgical care. The scope of this legislation is national, applying across Australia, as it is governed under Commonwealth law. The Declaration is contingent upon satisfying specific criteria outlined in the Health Insurance Regulations 1975, ensuring that the activity is both authorised and in the public interest. This Amendment Declaration commences the day after registration on the Federal Register of Legislative Instruments and will remain in effect for five years unless revoked sooner.
Key Provisions
The key operative sections of the legislation include Section 124X of the Health Insurance Act 1973, which allows the Minister or their delegate to make a Declaration that a specific activity is a quality assurance activity to which Part VC of the Act applies. The activity in question is the Australasian and New Zealand Audit of Surgical Mortality (ANZASM) carried out by the Royal Australasian College of Surgeons (RACS), which is amended to include reporting of incidents from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the Royal Australian and New Zealand College of Ophthalmologists (RANZCO). This activity was previously declared in QAA 4/2011. The Regulations, specifically sections 23C to 23G of the Health Insurance Regulations 1975, set out the public interest criteria that must be met by quality assurance activities in order to be declared under Section 124X of the Act.
The Act imposes several obligations and requirements on the parties or entities it governs. Firstly, the Minister or their delegate must be satisfied that the persons engaged in the quality assurance activity are authorised to do so, as outlined in Section 124X(3)(a) of the Act. This means that the individuals involved must be authorised either by an association of health professionals or by some other legitimate authority. Secondly, the Minister or their delegate must determine that it is in the public interest to have Part VC of the Act apply to the activity. This determination must be made with regard to the criteria prescribed by the Regulations, specifically sections 23C, 23D, 23E, 23F, and 23G. The activity, including the amendment, must meet these criteria in order to be declared as a quality assurance activity.
There are no specific offences, penalties, or civil/criminal consequences mentioned in the legislation for breach of the provisions outlined in this Declaration. However, the Declaration itself is a legislative instrument for the purposes of the Legislative Instruments Act 2003, which means that it carries the force of law and can be subject to review and revocation if necessary. The Declaration is in effect from the day after registration on the Federal Register of Legislative Instruments, and unless sooner revoked, it will cease to be in force at the end of 5 years after the instrument of Declaration was signed. This timeframe ensures that the Declaration remains current and relevant, while also allowing for periodic review and potential amendment if needed.