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. 2/2008
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 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 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 set out the public interest criteria that must be met by quality assurance activities in order to be declared under the section 124X.
The Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003. This Declaration has effect from the day after registration on the Federal Register of Legislative Instruments. Section 124X(4) of the Act proscribes that, unless sooner revoked, this determination ceases to be in force at the end of 5 years after the instrument of declaration was signed.
This Declaration under subsection 124X(1) applies Part VC of the Act to the following activities:
- The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) for Colposcopy Quality Framework (Item 1);
- Australasian Cardiac Surgery Research Institution Ltd (ACSRIL) for the Australasian Society of Cardiac and Thoracic Surgeons’ Database Program (ASCTS) (Item 2);
- Avant Mutual Group Limited for the Avant Fetal Ultrasound Clinical Risk Modification Framework (Item 3);
- St Andrew’s Medical Institute for the SAMI-Net Mitral Valve Repair Data Registry (Item 4); and
- St Andrew’s Medical Institute for the SAMI-Net Cardiac Surgery Data Registry (Item 5).
An overview of the activities for which the Declaration pursuant to s124X is made is contained in Attachment A.
CONSULTATION
Consultations regarding the application for declaration were undertaken from October 2007 to May 2008. 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 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;
- Members of the Qualified Privilege Advisory Group, which includes a clinician, members with expertise in health law, health care quality and ethics, and a consumer representative; and
- Sections of the Department of Health and Ageing including, Primary and Ambulatory Care Division, Acute Care Division and the Primary Care Division.
The Declaration of these activities will not result in any direct or substantial indirect effect on business.
ATTACHMENT A
OVERVIEW OF THE ACTIVITIES
Item 1 – Colposcopy Quality Framework
This activity involves an assessment or evaluation of the quality of health services; a study of the incidence or causes of conditions or circumstances that mat affect the quality of health services; and the making of recommendations about the provision of health services as a result of an assessment, evaluation or study. This Activity relates to health services funded through Medicare Benefits and Public Hospital funding arrangements.
The purpose of this Activity is to investigate the correlation between Colposcopy assessment and biopsy and to examine how practitioners can provide best service practices to the patient whilst undertaking colposcopy. This will be achieved by implementing an audit framework for rural and remote specialists to address issues arising from geographic isolation. Participating gynaecologists will invite their referring pathologist to participate in this audit project.
Item 2 – Australian Society of Cardiac and Thoracic Surgeons’ Database Program (ASCTS)
This Activity involves and assessment or evaluation of the quality of healthcare services and the making of recommendations about the provision of health services as a result of an assessment, evaluation or study. This Activity relates to health services funded through Medicare Benefits and Public Hospital funding arrangements.
The purpose of the Activity is to expand the Australasian Society of Cardiac and Thoracic Surgeons’ Cardiac Surgery Database program to eventually include all public and private hospital units. The Australasian Cardiac Surgery Research Institution Ltd (ACSRIL) have establised a a standardised database and definitions for clinical information on adult cardiac surgical patients. The activity includes the analysis of the collected data to statistically evaluate the adequacy of performance of participating hospital units and individual surgeons. The data set and definitions are reviewed bi-ennially in order to allow integration with other evolving databases.
Item 3 – Avant Fetal Ultrasound Clinical Risk Modification Framework
This activity involves the study of the incidence or causes of conditions or circumstances that may affect the quality of health services. This Activity relates to health services funded through Medicare Benefits and Public Hospital funding arrangements.
The purpose of the Framework is to assist ultrasonology practices to better manage the many inherent risks of antenatal fetal ultrasound. It consists of implementing a series of guidelines to be considered by each practice and adapted as logistics allow. This is a national audit and feedback program that aims to improve patient diagnostic outcomes following antenatal ultrasound procedures, to support practitioners and practice managers in managing clinical risk; and to provide useful feedback about participants’ practice patterns and outcomes compared with aggregate data collected from peers.
Item 4 – SAMI-Net Mitral Valve Repair Data Registry
This activity involves an assessment or evaluation of the quality of health services; a study of the incidence or causes of conditions or circumstances that mat affect the quality of health services; the making of recommendations about the provision of health services as a result of an assessment, evaluation or study; and the monitoring of the implementation of a recommendation about the provision of health services. This Activity relates to health services funded through Medicare Benefits; Public Hospital funding arrangements; and Health Program Grants.
The purpose of this Activity is to evaluate immediate, post operative and long term outcomes after mitral valve repair surgery through a focused audit. The St Andrew’s Medical Institute SAMI-Net Mitral Valve Repair Data Registry also serves the function of enabling the monitoring / sequential monitoring of trends in patient profile, technique, prosthetic device and intraoperative medication utilisation and success.
Item 5 – SAMI-Net Cardiac Surgery Data Registry
This activity involves an assessment or evaluation of the quality of health services; a study of the incidence or causes of conditions or circumstances that mat affect the quality of health services; the making of recommendations about the provision of health services as a result of an assessment, evaluation or study; and the monitoring of the implementation of a recommendation about the provision of health services. This Activity relates to health services funded through Medicare Benefits; Public Hospital funding arrangements; Health Program Grants; and the Pharmaceutical Benefits Scheme.
The purpose of this Activity is to evaluate immediate and post operative outcomes after cardiac surgery. The Registry also serves the function of enabling the monitoring / sequential monitoring of trends in patient profile, technique, prosthetic device and intraoperative medication utilisation and success.