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. 4/2008
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 activity:
- The Australian and New Zealand Tripartite Anaesthetic Data Committee Incident Recording and Reporting Program managed by the Australian College of Anaesthetists
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 may 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 and Public Hospital funding arrangements.
The purpose of this Activity is to improve the safety and quality of anaesthesia for patients by providing an enduring capability to capture analyse and disseminate de-identified information regarding anaesthetic incidents. Such incidents would include ‘near misses’ where no harm has occurred, in order to prevent future incidents. The project is designed to operate as an early warning system that alerts practitioners to potential risks independently of the reporting cycles of equipment manufacturers and pharmaceutical companies.
CONSULTATION
Consultations regarding the application for declaration were undertaken from May 2008 to August 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.
- Sections of the Department of Health and Ageing including the Mental Health and Workforce Division.
The Declaration of this activity will not result in any direct or substantial indirect effect on business.
Overview
The Health Insurance Act 1973, as amended, includes provisions aimed at ensuring the quality of health services funded by the government, such as through Medicare benefits and Public Hospital funding arrangements. Specifically, Part VC of the Act encourages quality assurance activities by protecting certain information from disclosure and providing some protection from civil liability to certain persons engaged in these activities in good faith. To apply Part VC to a particular activity, the Minister must make a declaration under Section 124X of the Act that the activity is a quality assurance activity to which Part VC applies. This process was utilised to recognise the Australian and New Zealand Tripartite Anaesthetic Data Committee Incident Recording and Reporting Program managed by the Australian College of Anaesthetists as a quality assurance activity. The primary objective of this declaration is to enhance the safety and quality of anaesthesia for patients by establishing a mechanism to capture, analyse, and disseminate de-identified information on anaesthetic incidents, including 'near misses' where no harm occurred, thereby serving as an early warning system for practitioners. This initiative operates independently of the reporting cycles of equipment manufacturers and pharmaceutical companies, aiming to prevent future incidents and improve patient outcomes.
Scope and Application
The Declaration of Quality Assurance Activities under Section 124X of the Health Insurance Act 1973 pertains to the Australian and New Zealand Tripartite Anaesthetic Data Committee Incident Recording and Reporting Program managed by the Australian College of Anaesthetists. This Declaration applies the provisions of Part VC of the Act, which aims to encourage efficient quality assurance activities within the health sector. These activities are designed to assess, evaluate, study, and recommend improvements to health services funded by the government through mechanisms such as Medicare Benefits and Public Hospital funding arrangements. The primary objective of this particular activity is to enhance the safety and quality of anaesthesia for patients by creating a system to record, analyse, and disseminate de-identified information about anaesthetic incidents, including 'near misses'. This initiative serves as an early warning system to alert practitioners of potential risks, operating independently of other reporting cycles. The Declaration applies nationwide as it is an instrument under the Commonwealth of Australia and is in force from the day after registration on the Federal Register of Legislative Instruments, unless revoked sooner. The Declaration will not result in any direct or substantial indirect effect on business.
Key Provisions
The Health Insurance Act 1973 (the Act) contains a scheme under Part VC that aims to encourage quality assurance activities in health services. This scheme is designed to protect certain information from disclosure and provide some protection from civil liability to those engaged in these activities in good faith (s 124X). To apply Part VC to a specific activity, the Minister must declare it as a quality assurance activity under section 124X. Regulations 23C to 23G of the Health Insurance Regulations 1975 outline the public interest criteria that must be met for an activity to be declared. The current Declaration applies Part VC to the Australian and New Zealand Tripartite Anaesthetic Data Committee Incident Recording and Reporting Program, managed by the Australian College of Anaesthetists. This program involves assessing or evaluating the quality of health services, studying the incidence or causes of conditions that may affect service quality, making recommendations based on these assessments, and monitoring the implementation of such recommendations (s 124X(2)(a)-(d)).
The obligations imposed by this Act on the parties involved in quality assurance activities are primarily focused on ensuring that the activities meet the specified criteria and are conducted in good faith. The Act requires that the Minister consult with relevant stakeholders before declaring an activity as a quality assurance activity. For the current Declaration, consultations were held from May to August 2008 with independent external referees, members of the Qualified Privilege Advisory Group, and sections of the Department of Health and Ageing. These consultations aimed to evaluate the potential value of declaring the activity, the methodology used, and whether the activity met the criteria for declaration, particularly those related to public interest (s 124X(3)(a)-(d)).
The Act provides protections to certain persons engaged in quality assurance activities. These protections include immunity from civil liability for actions taken in good faith in connection with the activities (s 124X(6)). Additionally, the Act protects certain information from disclosure, ensuring that sensitive data collected during the quality assurance activities cannot be disclosed without proper authorisation (s 124X(5)). Any breaches of these provisions can result in civil and criminal consequences. However, the Act does not specify maximum penalties for breaches, leaving this aspect to be addressed under other relevant legislation.
The Declaration of this activity is a legislative instrument under the Legislative Instruments Act 2003 and has effect from the day after registration on the Federal Register of Legislative Instruments. Unless revoked sooner, the determination ceases to be in force at the end of five years after the instrument of declaration was signed (s 124X(4)). The current Declaration is designed to improve the safety and quality of anaesthesia for patients by capturing, analysing, and disseminating de-identified information regarding anaesthetic incidents, including 'near misses', to prevent future incidents. This program operates as an early warning system, alerting practitioners to potential risks independently of the reporting cycles of equipment manufacturers and pharmaceutical companies.