Health Insurance Act 1973 - Declaration of Quality Assurance Activity under section 124X (QAA No. 1/2009)

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.  1/2009

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, 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 (the Regulations) 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 Re-declaration under subsection 124X(1) applies Part VC of the Act to the following activities:

1. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) – Perinatal Mortality and Morbidity: Learning from adverse events to improve care (Item 1) and;
2. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) – Nuchal Translucency – Ultrasound, Education and Monitoring Program (Item 2)

The activity at Item 1 of the Schedule was previously declared in 2004 (QAA 2/2004) and has the purpose of documenting, monitoring, analysing and managing potential and actual perinatal deaths or severe adverse events. This activity seeks to improve practice and reduce the number of perinatal deaths, by improving the audit investigation and peer review skills of specialists who have been involved in these adverse events.

The activity at Item 2 was previously declared in 2003 (QAA 3/2003) and has the purpose of maintaining the ultrasound practitioners ability to accurately measure the fetal nuchal translucency, through a process of continual audit by comparing current practice with current standards. This activity also includes the assessment or evaluation by a person of the services, skill or performance of a health care practitioner for the purpose of determining the health care practitioners clinical practicing rights.

An overview of the activities for which the Declaration pursuant to s124X is made is contained in Attachment A.

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 activities at Item 1 and 2 meet the requirements of paragraph 124X(3)(a) in that the persons engaged in these Activities are authorised to do so by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, 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. The criteria relevant to the activities are in regulations 23C, 23D and 23E or 23F.

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. Outcomes of the Activity will be disseminated to all Fellows of RANZCOG and RACP paediatrics division, the Committee of Presidents of Medical Colleges and the Department of Health and Ageing via the Support Scheme for Rural Specialists.
• Regulation 23D does not apply as the activity will be engaged in more than one State or Territory.
• Regulation 23E does not apply as the activity has previously been engaged in Australia.
• Regulation 23F applies as the activity has previously been carried out in Australia and is a re-declaration of activity QAA 2/2004 . The Minister’s re-declaration will continue to encourage 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 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. Outcomes of the Activity include regular reporting to the Department of Health and Ageing, Australian and New Zealand Obstetrics and Gynaecology Journal and papers will also be presented to the medical literature for publication
• Regulation 23D does not apply as the activity will be engaged in more than one State or Territory.
• Regulation 23E does not apply as the activity has previously been engaged in Australia.
• Regulation 23F applies as the activity has previously been carried out in Australia and is a re-declaration of activity QAA 3/2003. The Minister’s re-declaration will continue to encourage 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 23G applies as the activity includes 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

Consultations regarding the applications for re-declaration were undertaken from February 2009 to April 2009.  This included obtaining advice on the potential value of re--declaring the activities as quality assurance activities for the purposes of the Act, the methodology used to conduct the activities, and whether the applications met the criteria required for declaration, in particular those criteria relating to whether it is in the public interest to re-declare the activities.

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 quality manager working in the field of health care quality assurance; and

­       a consumer representative.

The re-declaration of these activities 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 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. 1/2009

ATTACHMENT A

OVERVIEW OF THE ACTIVITIES

1. PURPOSE OF ACTIVITIES

The purpose of the activity at Item 1 is for The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) Fellows to continue an audit project, which seeks to improve the audit investigation and peer review skills of specialists who have been involved in perinatal deaths or severe adverse events. The information will be used for clinical audit of the surgical practices of clinicians for the purpose of quality assurance and clinical research purposes. Understanding what to do when there is a perinatal death is a core set of skills that obstetricians and paediatricians need in working in clinical practice.

The objectives of the activity are to:

• Understand how and what to audit after a perinatal death
• For clinicians to improve their own clinical management and develop and action plan.
• How to communicate and provide feedback for clinicians and rural specialists

The purpose of the activity at Item 2 is for RANZCOG Fellows to continue the audit component of the ultrasound scan program. The program certifies and maintains certification of ultrasound operators who perform the first trimester scan using FMF software. Registered centres and operators, who use the FMF software are required to submit their nuchal translucency ultrasound data annually to be assessed. Should the audit and assessment of images return a satisfactory result a ‘Licence Renewal File’ is sent to the operator reactivating the FMF software for a further 12 months. Should the audit return a less than satisfactorey result the operators license will be withdrawn and a practical training session with an expert will be scheduled. The objective of the activity is to maintain the ultrasound practitioners ability to accurately measure the fetal nuchal translucency in the first trimester ultrasound scan, by assessing the operator’s level of skill in the measurement of the fetal nuchal translucency.