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. 1/2006
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 s124X 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 s124X(1) applies Part VC of the Act to the Australian Patient Safety Foundation – Advanced Incident Management System (Item 1).
As required by section 124W(1) of the Act, the Activity relates to the quality of health services which would be eligible for payment of Medicare Benefits and Public Hospital Services.
An overview of the activity for which the Declaration pursuant to s124X will be made is contained in Attachment A
Written consultations on the application for declaration of the Activity were undertaken from January to May 2006. This included obtaining advice on the potential value of declaring the activity as a quality assurance activity for the purposes of the Act, the methodologies 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; and
- members of the Qualified Privilege Advisory Group, which includes an expert clinician, a legal expert, a consumer representative and a quality manager working in the field of health care quality assurance.
Comments received during the consultation process supported the declaration of the Activities.
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 was signed by the Minister on 7 June 2006 and comes into operation
on the day after registration with the Federal Register of Legislative Instruments.
As provided by section 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. 1/2006
Attachment A
Overview of the activitY
1. PURPOSE OF ACTIVITY
The purpose of the Activity is to provide a mechanism that will investigate and analyse an incident and/or adverse event in a health service. The objective of the Activity is to improve the capture and analysis of adverse event data in order to facilitate the implementation of changes aimed at improving quality and safety.
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 section 124X(3)(a) of the Act.
The Activity at Item 1 meets the requirements of section 124X(3)(a) of the Act in that the persons engaged in this Activity are authorised to do so by the Australian Patient Safety Foundation, which is an association of health professionals and a body established wholly or partly for the purpose of research, and the bodies that provide health services operating AIMS.
Secondly, Para 124X(3)(b) 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 section 124X(3)(b) of the Act. The criteria relevant to the Activities at Item 1 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 non-identifying information regarding the quality of the services evaluated and the factors affecting the quality of service. The persons engaged in the Activity will collect non-identifying information from the Activity through specific mechanisms of the Advanced Incident Management System, which may then be published in aggregated and cumulative form. Information from the Activity will be published in academic journals such as the Quality and Safety in Healthcare and presented in papers at national and international conferences.
- Regulation 23D does not apply as the activity will be engaged in more that one State or Territory.
- Regulation 23E does not apply as the activity has previously been engaged in Australia.
- Regulation 23F applies as the Minister is satisfied that the Activity is of a kind that has been engaged in Australia before. Item 2 is based entirely upon the Gove District Hospital Australian Incident Monitoring System which was declared as a Quality Assurance Activity under the Act on 6 June 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.
This is achieved by limiting the declared activity to the investigation and analysis phase (Phase 2) of the existing Advanced Incident Management System. The Activity as described would allow collection of information through a single point without unnecessarily restricting some sorts of information, the disclosure of which is desirable.
- 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.