Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 8/2016

EXPLANATORY STATEMENT

ISSUED BY THE AUTHORITY OF THE MINISTER FOR HEALTH

HEALTH INSURANCE ACT 1973

DECLARATION OF QUALITY ASSURANCE ACTIVITY UNDER SECTION 124X OF THE HEALTH INSURANANCE ACT 1973 - QAA 8/2016

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, including through Medicare benefits, the Pharmaceutical Benefits Scheme, 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 is a quality assurance activity to which Part VC applies. 

The Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 8/2016 (the Declaration) has effect from the day after registration on the Federal Register of Legislation.   

The Declaration applies Part VC of the Act to the following activity, to the extent it relates to health services provided in Australia:

1. Australian and New Zealand Intensive Care Society (ANZICS): ANZICS Centre for Outcome and Resource Evaluation (CORE) Intensive Care Registries:
   • Adult Patient Database
   • Critical Care Resources Registry Survey
   • Australian New Zealand Paediatric Intensive Care Registry
   • The Central Line Associated Bloodstream Registry

An overview of the activity is contained in Attachment A.

Before making a declaration under section 124X, the Minister must be satisfied that the persons engaged in the activity are authorised to do so in one of the ways described in paragraph 124X(3)(a) of the Act.  The persons engaged in the CORE Intensive Care Registries are authorised to do so by the ANZICS which is an association of health professionals and an educational institution (see subparagraphs 124X(3)(a)(vi) and (iv)).

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 activity. In doing so, the Minister must have regard to criteria prescribed by regulation. The criteria are set out in regulations 23C to 23G of the Health Insurance Regulations 1975.

The activity meets the criteria as follows:

• As required by regulation 23C, CORE Intensive Care Registries includes the disclosure of non-identifying information that concerns the quality of service assessed, evaluated or studied. CORE Intensive Care Registries develops annual activity reports for each Registry based on aggregated non-identifiable data disseminated to stakeholders in Commonwealth and state departments of health, hospitals and international intensive care societies.
• Regulation 23D does not apply as CORE Intensive Care Registries will be undertaken in more than one State or Territory.
• Regulation 23E does not apply as CORE Intensive Care Registries has previously been engaged in Australia.
• Regulation 23F applies as CORE Intensive Care Registries has previously been carried out in Australia. The application of Part VC of the Act to the activity will encourage greater participation in it 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 23G does not apply as CORE Intensive Care Registries will 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.

CONSULTATION

ANZICS have two of the registries listed in the application (Centre for Outcome and Resource Evaluation (CORE) – Australian and New Zealand Intensive Care Adult Patient Database, and Australian and New Zealand Intensive Care Paediatric Intensive Care (ANZPIC) registry) declared to be quality assurance activity under section 124X of the Act (see Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 (QAA 2/2011)). ANZICS applied to continue their activity as being a quality assurance activity.

An assessment of the application included an assessment of 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 as set out in the Regulations.

The declaration of this activity will not result in any direct or substantial indirect effect on business.

The Declaration comes into operation on the day after registration on the Federal Register of Legislation.

Subsection 124X(4) of the Act provides that, unless sooner revoked, a declaration ceases to be in force at the end of 5 years after it was signed.  Accordingly, the Declaration provides that it is repealed at the end of 5 years after it is signed.

ATTACHMENT A

OVERVIEW OF THE ACTIVITY

1.                PURPOSE OF ACTIVITY

The Australian and New Zealand Intensive Care Society (ANZICS) is the leading advocate on all intensive care –related matters throughout the two countries. The ANZICS Centre for Outcome and Resource Evaluation (CORE) is run by the Society with the purposes of auditing and benchmarking of Intensive Care Unit (ICU) performance across Australia and New Zealand through the Adult Patient Database, the Paediatric Intensive Care Registry, the Critical Care Resources Registry and the ICU Central Line Associated Bloodstream Infection Registry.

The Centre for Outcome and Resource Evaluation hosts the following four ICU registries:

1. The Adult Patient Database (APD) hosts data on ICU admissions related to patient outcomes and severity of illness
2. The Critical Care Resources (CCR) Registry Survey annually collects resources and activity data from 80% of all Australian and New Zealand ICUs.
3. The Australian New Zealand Paediatric Intensive Care Registry (ANZPICR) collects data from all paediatric ICUs and paediatric data from mixed adult/paediatric units.
4. The Central Line Associated Bloodstream Infection (CLABSI) Registry monitors rates of CLASBSI in Australian Intensive Care Units.

The objectives of the ANZICS CORE Registries are to:

• Benchmark and monitor Intensive Care Unit activity, performance and outcome
• Provide timely, accurate information to clinicians, the public, policy-makers, health care providers and jurisdictional governments
• Work with the Intensive Care community to prioritise registry activities that will promote improvements in care of the criticaly ill
• Develop the activities of ANZICS CORE through local, national and international collaboration

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Declaration of Quality Assurance Activity under section 124X of the
Health Insurance Act 1973 - QAA 8/2016

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the
Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 8/2016 (the Declaration) declares the Australian and New Zealand Intensive Care Society (ANZICS) Centre for Outcome and Resource Evaluation (CORE) Intensive Care Registries to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 (the Act) applies.  Part VC establishes a scheme to encourage efficient quality assurance activities.  Information known solely as a result of the ANZICS Core Intensive Care Registries, and documents created solely for the purpose of ANZICS Core Intensive Care Registries, will be covered by qualified privilege.

Human rights implications

This Declaration engages the right to health as set out in Article 12 of the International Covenant on Economic, Social and Cultural Right (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The Qualified Privilege Scheme established by Part VC of the Act is aimed at encouraging participation in quality assurance activities that help ensure the highest possible health care standards are maintained. The quality assurance activities described in this Declaration will provide participants with a great degree of confidence and security that their participation is solely for the benefit of establishing and improving outcomes of the community health care.

Conclusion

This Declaration is compatible with human rights as it promotes the right to health.