EXPLANATORY STATEMENT
ISSUED BY THE AUTHORITY OF
THE MINISTER FOR HEALTH AND AGEING
HEALTH INSURANCE ACT 1973
DECLARATION OF QUALITY ASSURANCE ACTIVITIES UNDER SECTION 124X
QAA No. 2/2004
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, for example, through Medicare benefits. The scheme encourages participation in such activities by protecting certain information from disclosure, and also by protecting the persons engaged in those activities, in good faith, from civil liability in respect of those activities. In order for Part VC to apply to an activity, the Minister must make a Declaration.
This Declaration applies Part VC of the Act to the Advanced Incident Monitoring System - Royal Darwin Hospital and Top End Mental Health Service (Item 1), Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and Royal Australasian College of Physicians (RACS) perinatal mortality audit program for rural obstetricians and paediatricians (Item 2), and the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S) – audit of the endoluminal repair of abdominal aortic aneurysms (Item 3) – (the Activities).
The Declaration is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.
The Activities relate to the quality of health services which would be eligible for payment in respect of Medicare Benefits and, in some cases, public hospital services (Item 3).
The Activity at Item 1 of the Schedule has the purposes of documenting, monitoring, analysing and managing potential and actual adverse patient and visitor events. The Activity at Item 2 of has the purposes of improving the audit, investigation and peer review skills of specialists who have been involved in perinatal deaths. The Activity at Item 3 of the Schedule has the purposes of establishing the safety of the surgical (endoluminal) procedure; establishing the efficacy of this procedure; making the results widely known; and using the information in surgical training and clinical decision making.
Before the Minister can make a declaration, certain requirements must be met.
Firstly, the organisations engaged in the activities must be authorised to do so. The authorisation can be by an association of health professionals, by a body that provides health care or by an educational institution. The organisation engaged in the Activity under Item 1 of the Schedule is authorised to do so by the Royal Darwin Hospital and Top End Mental Health Service, bodies that provides health care.
The organisation engaged in the Activity under Item 2 of the Schedule is comprised of members of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and Royal Australasian College of Physicians (RACP) practice improvement program for rural specialist obstetricians and paediatricians which is authorised to engage in the Activity by the RANZCOG and RACP, associations of health professionals.
The organisation engaged in the Activity under Item 3 of the Schedule is comprised of members of The Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S) which is authorised to engage in the Activity by the Royal Australasian College of Surgeons (RACS), an association of health professionals.
Secondly, the Minister has to be satisfied that it is in the public interest to have Part VC of the Act apply to the Activities. The Minister must have regard to criteria prescribed by the regulations. The criteria relevant to the Activities are in regulations 23C, 23D and 23E or 23F of the Health Insurance Regulations. The Activities meet those criteria as follows:
· as required by Regulation 23C, the Activities include the disclosure of non-identifying information that concerns the quality of service assessed, evaluated or studied or the factors affecting the quality of the service, thereby satisfying the requirement that information is provided at times and in a manner acceptable to the Minister. In the Activity under Item 1 of the Schedule, non-identifying information will be made available in aggregated form. Copies of such information will be provided to the Minister for Health and Ageing. In the Activity under Item 2 of the Schedule, the outcomes will be published in Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Royal Australasian College of Physicians, and quality in health care journals. Copies of publications will be available to the Minister for Health and Ageing. In the Activity under Item 3 of the Schedule the organisation engaged in the Activity will provide non-identifying results of the Activity to the Department of Health and Ageing and the Royal Australasian College of Surgeons. Non-identifying information will also be published in peer reviewed and consumer journals, and presented at specialist meetings. Copies of such information will be available to the Minister for Health and Ageing.
· as required by Regulation 23D, the Minister is satisfied that the Activity under Item 1 is of national importance because the data generated by the project will feed into a national incident monitoring database. As required by Regulation 23D, the Minister is satisfied that the Activity under Item 2 comprises a pilot study for the purpose of investigating whether a methodology of a particular kind can be used in Australia. Item 3 is exempt from Regulation 23D as its Activities are being undertaken in more than one state.
· as required by Regulation 23E, the Minister is satisfied that the Activities under Item 2 of the Schedule is of a kind that have not been engaged in Australia before because none has been declared and the necessary protections for those participating were not available. The Declaration is needed to ensure that the Activity has the protections of immunity from suit and prohibitions on the disclosure of information. These are to make the Activity effective, by encouraging the full participation in the Activity of persons who provide health services.
· as required by Regulation 23F, the Minister is satisfied that the Activities under Items 1 and 3 are of a kind that have been engaged in Australia before. In respect of Item 1, a number of incident monitoring activities have previously been declared. The application of Part VC of the Act is necessary for Item 1 to encourage participation in the Activity by persons who provide health services to a greater extent than the participation in previous activities because it will encourage the participation by persons who provide health services at the Royal Darwin Hospital and Top End Mental Health Service in addition to participation by other persons in previous activities. In respect of Item 3, this activity has been previously declared (QAA No. 1/1999). The application of Part VC of the Act is necessary for Item 3 to encourage greater participation by persons who provide health services to a greater extent than the participation in previous activities.
A Regulation Impact Statement (RIS) is not necessary for this Declaration because the declaration of the activity will not have a direct or substantial indirect effect on business.
The Declaration was signed by the Minister on 31 August 2004 and comes into operation on the date of gazettal. As provided by subsection 124X (4) a declaration ceases to be in force at the end of 5 years after the instrument of declaration is signed, unless revoked earlier.
QAA No. 2/2004