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. 3/2006
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 of the Act to apply to an activity, the Minister may 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.
The Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
This Declaration under subsection 124X(1) applies Part VC of the Act to the following activities:
- Royal Australasian College of Surgeons – Audit of Surgical Mortality (Item 1);
- Royal Australian and New Zealand College of Obstetricians and Gynaecologists – Laparoscopy in gynaecology and surgery: practice review using audit of errors for improving safety (Item 2);
- Australian and New Zealand Intensive Care Society - Australian and New Zealand Paediatric Intensive Care Registry (Item 3); and
- Australian Orthopaedic Association – National Joint Replacement Registry (Item 4).
The Activities at Item 1, 2, 3 and 4 relate to the quality of health services which would be eligible for payment of Medicare Benefits and Public Hospital Services and therefore they fall within the definition of ‘quality assurance activity’ in subsection 124(1) of the Act.
An overview of the activities for which the Declaration pursuant to s124X is made is contained in Attachment A.
CONSULTATION
Written consultations on the applications for declaration were undertaken from June to August 2006. This included obtaining advice on the potential value of declaring each activity as a quality assurance activity for the purposes of the Act, the methodologies used to conduct the activities and whether each application met 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:
- independent external referees nominated by the applicant; and
- members of the Qualified Privilege Advisory Group, which includes an external clinician, a legal expert, a consumer representative and a quality manager working in the field of health care quality assurance.
A Regulation Impact Statement (RIS) is not necessary for these Declarations because the declaration of the activity will not have a direct or substantial indirect effect on business.
The Declaration comes into operation on 6 November 2006.
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. 3/2006
Attachment A
Overview of the activities
1. PURPOSE OF ACTIVITIES
The purpose of the Activity at Item 1 is to undertake a peer review of surgically related deaths to improve the quality of surgical care and patient safety.
The purpose of the Activity at Item 2 is to undertake a practice review of laparoscopy in gynaecology and surgery using an audit of errors for improving safety. The laparoscopy audit will enable specialists in rural and remote areas to compare and benchmark their results and provide support for developing action plans and implementing change to improve patient safety.
The purpose of the Activity at Item 3 is to describe the incidence, aetiology, severity and outcome of paediatric critical illness and injury. The objective of the Activity is to compare and benchmark the quality of care for children in intensive care units.
The purpose of the Activity at Item 4 is to collect and analyse performance data related to the treatment of joint replacements which will assist in reducing the probability of adverse outcomes. The objectives of the Activity are to:
- document the performance of replacement joints; and
- provide information to practitioners on the performance of implants and techniques.
2. REQUIREMENTS TO BE MET
Before the Minister can make a declaration, certain requirements must be met.
Firstly, the Minister 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 Activity at Item 1 meets these requirements of paragraph 124X(3)(a) in that the persons engaged in this Activity are authorised to do so by the Royal Australasian College of Surgeons, which is an association of health professionals.
The Activity at Item 2 meets the requirements of paragraph 124X(3)(a) of the Act in that the persons engaged in this Activity are authorised to do so by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists in collaboration with the Royal Australian College of Surgeons and the Australian and New Zealand College of Anaesthetists which are associations of health professionals.
The Activity at Item 3 meets the requirements of paragraph 124X(3)(a) of the Act in that the persons engaged in this Activity are authorised to do so by the Australian and New Zealand Intensive Care Society which is an association of health professionals.
The Activity at Item 4 meets the requirements of paragraph 124X(3)(a) of the Act in that the persons engaged in this Activity are authorised to do so by the Australian Orthopaedic Association which is an association of health professionals.
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 Activities. In doing so, the Minister must have regard to criteria prescribed by the regulations.
Regulation 23B of the Health Insurance Regulations 1975 (the Regulations) provides that the criteria stated in regulations 23C to 23G (inclusive) are prescribed for the purposes of paragraph 124X(3)(b) of the Act. The criteria relevant to the Activity at Item 1 are in regulations 23C and 23F of the Regulations. The criteria relevant to the Activities at item 2 are in regulations 23C and 23E of the Regulations. The criteria relevant to the Activities at Item 3 are in regulations 23C and 23F of the Regulations. The criteria relevant to the Activities at Item 4 are in regulations 23C and 23F of the Regulations.
The Activity at Item 1 meets the criteria as follows:
- As required by regulation 23C, the Activity includes the disclosure of information regarding the factors affecting the quality of surgical procedures. Non-identifying information regarding audit participation rates, suboptimal care associated with the care of the patient and yearly outcomes will be reported in annual reports that will be posted on the Royal Australian College of Surgeons web site (www.surgeons.org).
- Regulation 23D does not apply as the activity will be engaged in in more than one State or Territory.
- Regulation 23E does not apply as the activity has been engaged in previously in Australia.
- For the purposes of regulation 23F, the Minister is satisfied that the Activity is of a kind that has been engaged in previously in Australia. Item 1 is based upon the Western Australian Audit of Surgical Mortality which was declared as a Quality Assurance Activity under the Act on 5 November 2001 by the then Minister for Health and Aged Care, Dr Michael Wooldridge. The Declaration is needed to make the Activity effective by introducing a national activity thereby encouraging participation to a greater extent than the previous activity by persons who provide health services. The declaration will encourage regions outside Western Australia to participate in the program by reassuring participants that individual identifying details are protected from disclosure.
- Regulation 23G does not apply as the activity does 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.
The Activity at Item 2 meets the criteria as follows:
- As required by regulation 23C, the Activity includes the disclosure of aggregated data from the project. Dependent on the results of the data collected, the outcomes are likely to provide information regarding the following matters:
- the profile of the types and frequency of laparoscopic procedures occurring in regions of Australia;
- a benchmark for errors occurring in laparoscopy procedures and associated anaesthesia;
- a comparison between clinical differences between gynaecological and surgical delivery of laparoscopy and impact on complications/adverse outcomes;
- a regional overview of technological differences of equipment; and
- perceptions, attitudes and values towards audits and laparoscopy error.
The aggregated outcomes and feedback from the project will be published in the journals of the participating colleges, as well as with the Support Scheme for Rural Specialists and in quality health care journals.
- Regulation 23D does not apply as the activity will be engaged in in more that one State or Territory.
- The requirements of regulation 23E apply as the Minister is satisfied that the Activity is of a kind that has not been engaged in Australia before. As required by regulation 23E the Declaration is needed to encourage full participation in the Activity by persons who provide health services. The Declaration will encourage gynaecologists, surgeons and anaesthetists to participate in open discussions about laparoscopic practice in regional Australia by reassuring participants that identifying information provided will be protected from disclosure, including to a court, in accordance with Part VC of the Act.
- Regulation 23F does not apply as the activity has not previously been engaged in in Australia.
- Regulation 23G does not apply as the activity does 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.
The Activity at Item 3 meets the criteria as follows:
- As required by regulation 23C, the Activity includes the disclosure of information that concerns the quality of service assessed, evaluated or studied or the factors affecting the quality of the service. Non-identifying information will be presented, in the form of a report to the Australian and New Zealand Intensive Care Society (ANZICS) annual conference and then published on the ANZICS web site (www.anzics.com.au).
- Regulation 23D does not apply as the activity will be engaged in in more than one State or Territory.
- Regulation 23E does not apply as the activity has been engaged in previously in Australia.
- For the purposes of regulation 23F, the Minister is satisfied that the Activity is of a kind that has been engaged in Australia before. Item 3 is based entirely upon the Australian and New Zealand Intensive Care Society – Australian and New Zealand Paediatric Intensive Care Registry which was declared as a Quality Assurance Activity under the Act on 5 November 2001 by the then Minister for Health and Aged Care, Dr Michael Wooldridge. The Declaration is needed to make the Activity effective by encouraging participation to a greater extent than the previous activity by persons who provide health services. The declaration will encourage intensive care units who have not yet undertaken the activity, as well as new practices opening in the future, to participate in the program by reassuring participants that individual identifying details are protected from disclosure.
- Regulation 23G does not apply as the activity does 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 practicing rights.
The Activity at Item 4 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 or the factors affecting the quality of the service. Non-identifying information relating to patient demographics and outcomes will be presented, in the form of a report, to surgeons and government organisations. In addition, non-identifying information will be provided on request to surgeons, hospitals and orthopaedic manufacturing companies.
- Regulation 23D does not apply as the activity will be engaged in in more that one State or Territory.
- Regulation 23E does not apply as the activity has previously been engaged in in Australia.
- Regulation 23F applies as the Minister is satisfied that the Activity is of a kind that has been engaged in previously in Australia. Item 3 is based entirely upon the Australian Orthopaedic Association – National Joint Replacement Registry which was declared as a Quality Assurance Activity under the Act on 5 November 2001 by the then Minister for Health and Aged Care, Dr Michael Wooldridge. The Declaration is needed to make the Activity effective by encouraging participation by persons who provide health services to a greater extent than the previous activity. Declaration of the National Joint Replacement Registry will allow for the expansion of the joints types included in the register thereby capturing a different cohort of hospitals and surgeons.
- Regulation 23G does not apply as the activity does not include the assessment or evaluation by a person of the services, skill or performance of a health practitioner for the purposes of determining the health care practitioner’s practicing rights.