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. 1/2005
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 Tasmanian Audit of Surgical Mortality (TASM) (Item 1);
- The ACT Audit of Periprocedural and Perioperative Mortality (AAPPM) (Item 2); and
- The National Breast Cancer Audit (Item 3)
– (the Activities).
The Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The Activities relate to the quality of health services which would be eligible for payment of Medicare Benefits and Public Hospital Services as required by Section 124W(1) of the Act.
The Activity at Item 1 of the Schedule has the purpose of assessing and evaluating the safety and quality of surgical care in Tasmania, with a particular reference to the audit of all post-operative surgical mortality within 30-days of a surgical procedure.
The activity at Item 2 of the Schedule has the purpose of the assessing and evaluating the safety and quality of periprocedural and perioperative care in the ACT, with a focus on independently peer reviewing all deaths which occur within 30 days of surgery, or while the patient is under the care of the surgeon, regardless of whether an operation has taken place.
The activity at Item 3 of the Schedule has the purpose of assessing and evaluating the quality of health services through the collection and oversight of data relating to surgery for early breast cancer. This Activity also includes the assessment or evaluation by a person of the services, skill or performance of a health care practitioner for the purpose of determining the health care practitioner’s rights to full membership of the Breast Section of RACS and the making of findings on material questions of fact or law.
Before the Minister can make a declaration, certain requirements must be met.
Firstly, the persons engaged in the activities must be authorised to do so. The authorisation can be by a law of the Commonwealth, or a State or Territory; by the government or an authority of the Commonwealth, a State or a Territory; by an association of health professionals; by a body that provides health care; by a body established wholly or partly for the purposes of research; or by an educational institution.
- The persons engaged in the Activity at Item 1 of the Schedule are authorised to do so by the Tasmanian State Government and the Royal Australasian College of Surgeons, which is an association of health professionals.
- The persons engaged in the activity at Item 2 of the Schedule are authorised to do so by the Australian Capital Territory Government and the Royal Australasian College of Surgeons - ACT Committee, which is an association of health professionals.
- The persons engaged in the Activity at Item 3 of the Schedule are authorised to do so by the Royal Australasian College of Surgeons, which is 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, de-identified information will be made available through annual reports to both State and Federal Health Ministers and through publishing scholarly journal articles.
- In the Activity under Item 2 of the Schedule, de-identified information made available through annual reports, copies of which will be available to the Minister for Health and Ageing.
- In the Activity under Item 3 of the Schedule, non-identifying information from the breast audit will be submitted to the Safety and Quality Branch of the Australian Government Department of Health and Ageing, and the State Quality Officials Forum. Non-identifying information will also be reported the annual it to hospitals (aggregated hospital data on procedures compared with the state and national average and minimum standards plus hospital caseload data) and State health departments (aggregated on hospital, State and national plus State caseload). Progress reports of aggregated data will be made available on the ASERNIP-S web site for general access. In addition papers will be published in peer review journals and consumer journals as well as presented specialist meetings. Copies of reports will be made available to the Minister for Health and Ageing.
- As required by Regulation 23D, the Minister is satisfied that the Activities under Items 1 and 2 are of national importance and have the potential to affect the quality of health care on a national scale because de-identified information gained from these activities will feed into a national audit that will coordinate the assessment and evaluation of the safety and quality of surgical care in Australia. Regulation 23D is not applicable to the Activity at Item 3 as it is being undertaken in more than one state.
- As required by Regulation 23E, the Minister is satisfied that the Activity under Item 3 of the Schedule is of a kind that has not been engaged in Australia before in that it uses an expanded methodology that includes individual peer review against newly developed minimum standards. These standards were developed by the RACS's Audit Clinical Advisory Committee and Audit Technical Advisory Committee and are based on the Australian Clinical Practice Guidelines for the management of early breast cancer. The Declaration is needed to ensure that the Activity has the protections of immunity from suit and prohibitions on the disclosure of information. This will 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 2 are of a kind that have been engaged in Australia before. Both Items 1 and 2 are fully based on the Western Australia Audit of Surgical Mortality, which was declared as a Quality Assurance Activity under the Act on 7 November 2001 by the then Minister for Health and Ageing, Dr Michael Wooldridge. The application of Part VC of the Act is necessary for Items 1 and 2 to encourage participation in the Activity by persons who provide health services to a greater extent than the previous activity. This is achieved by taking the previous Western Australian based activity to include health professionals working in Tasmania and the ACT.
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 10/5/2005 and comes into operation on the day after registration with the Federal Register of Legislative Instruments. 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. 1/2005