Health Insurance Act 1973 - Declaration of quality assurance activity under section 124X (QAA No. 1/2007)

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.  1/2007

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 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:

• Colorectal Surgical Society of Australia and New Zealand (CCSANZ), Royal College of Surgeons – Research and Audit (RACS) and Molecular Medicine Informatics Model (MMIM) for the Bi‑National Colorectal Cancer Audit

      (Item 1); 

• The Royal College of Obstetricians and Gynecologists (RANZCOG) for the Obstetrician Locum and Host Practice Review (Item 2); and
• The Australian College of Midwives for the Midwifery Practice Review

      (Item 3).

The activities at Item 1, 2 and 3 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 April to May 2007. This included obtaining advice on the potential value of declaring each activity as a quality assurance activity for the purpose 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;
• 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; and
• Sections of the Department of Health and Ageing including, Primary and Ambulatory Care Division, Acute Care Division and the Primary Care Division.

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 the day after registration on 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. 1/2007

ATTACHMENT A

OVERVIEW OF THE ACTIVITIES

1. PURPOSE OF ACTIVITIES

The purpose of the Activity at Item 1 is to undertake The Bi-National Colorectal Cancer Audit combining data often held in different databases by different organisations. The Colorectal Surgical Society of Australia and New Zealand (CSSANZ) has determined that a bi-national colorectal database should be established so that data can be collected by its members and other surgeons. The information will be used for clinical audit of the surgical practices of members for the purpose of quality assurance and clinical research purposes. The objective of the Activity is to establish an audit of the treatment of colorectal cancer by the Australian surgical community to ensure that the treatment of colorectal cancers by Australian surgeons is performed to the highest possible standard.

The purpose of the Activity at Item 2 is for The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) Fellows to ensure that locums operate within a quality framework. Some Fellows / GP obstetricians work exclusively as locums and have no opportunity for peer review. This project has been developed to support the locum and to promote safe quality care. The objectives of the Activity are to:

• Provide the individual locum and host with recommendations in improving quality and minimising risk;
• Provide peer support and feedback from colleagues working in similar circumstances;
• To identify strengths and assess relative risks within a practice which if modified may lead to improved patient outcomes and satisfaction as well as a reduction in the incidence of medico legal issues for the Fellow/GP obstetrician involved.
• Provide the locum and host Fellows/GP obstetricians the opportunity to gain Continuing Professional Development Program (CPD) credits in the practice review and clinical risk management category of their mandatory RANZCOG continuing professional development in order to maintain their Fellowship.

The purpose of the Activity at Item 3 is to undertake an external peer review evaluation of the practice of individual midwives. It is a quality and safety process utilising presentation of evidence of ongoing professional development, competency and reflection of practice through an interview process. The objectives of the Activity are to:

• Encourage midwives to maintain professional competence; and
• Encourage midwives to reflect on their practice in the form of summaries of their practice.

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) 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, which is an association of health professionals.

The Activity at Item 3 meets the requirements of paragraph 124X(3)(a) in that the persons engaged in this Activity are authorised to do so by the Australian College of Midwives, 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 23E of the Regulations. The criteria relevant to the Activity at Item 2 are in regulations 23C and 23E of the Regulations. The criteria relevant to the Activity at Item 3 are in regulations 23C and 23E 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 that concerns the quality of service assessed, evaluated or studied.  Reports will be submitted to the Colorectal Surgical Society of Australia and New Zealand (CSSANZ), the Royal Australian College of Surgeons (RACS) and the Molecular Medicine Informatics Model project (MMIM) as interested and financial parties of the audit. The progress of the audit will be reported yearly to RACS and progress reports of aggregated data will be made available on the RACS and CSSANZ web-site for general access. Individual surgeons will have access to their own data and results.
• Regulation 23D does not apply as the activity will be engaged in more than one State or Territory.
• Regulation 23E applies because the Minister is satisfied that the Activity is of a kind that has not been engaged in previously in Australia. The Declaration is needed to make the Activity effective by encouraging full participation in the Activity by persons who provide health services by providing participants with a greater degree of confidence and security that their participation is solely to the benefit of establishing and improving quality assurance.

• Regulation 23F does not apply as the Activity has not previously been carried out 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 2 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.  The evaluation of the locum / host practice review activity will be published in the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) O&G Magazine. This publication is mailed to all RANZCOG Fellows and GP Obstetricians in Australia and New Zealand.
• Regulation 23D does not apply as the activity will be engaged in more than one State or Territory.
• Regulation 23E applies because the Minister is satisfied that the Activity is of a kind that has not been engaged in previously in Australia. The Declaration is needed to make the Activity effective by encouraging full participation in the Activity by persons who provide health services by providing participants with a greater degree of confidence and security that their participation is solely to the benefit of establishing and improving quality assurance.
• Regulation 23F does not apply as the Activity has not previously been carried out 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 practitioners clinical practicing rights.

The Activity at Item 3 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.  Non-identifying information regarding the processes and outcomes will be published in the newsletter of the College – Australian Midwifery News. Further publications regarding the outcomes and analysis of the data obtained may occur in further journals including the Women and Birth (the Journal of the Australian College of Midwives).
• Regulation 23D does not apply as the activity will be engaged in more than one State or Territory.
• Regulation 23E applies because the Minister is satisfied that the Activity is of a kind that has not been engaged in previously in Australia. The Declaration is needed to make the Activity effective by encouraging full participation in the Activity by persons who provide health services by providing participants with a greater degree of confidence and security that their participation is solely to the benefit of establishing and improving quality assurance.

• Regulation 23F does not apply as the Activity has not previously been carried out 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.