Background on the Framework for Australian Clinical Quality Registries
In 2014, Australian Health Ministers endorsed the Framework for Australian clinical quality registries (incorporating the Operating principles and technical standards for clinical quality registries).
In 2016, the Commission developed the Prioritised list of clinical domains for clinical quality registry development. In 2019, in line with the Commission’s Work Plan, the Commission convened the Clinical Quality Registry Framework Review Advisory Group to advise on the revision of the Framework for Australian clinical quality registries (2014 version).
Since releasing the Framework (2014), the Commission received feedback from registry stakeholders, indicating that the Framework is well accepted, however stakeholders identified further guidance on governance and updated guidance on national infrastructure and security compliance to maximise operational efficiency of CQRs, was needed.
The Framework 2nd edition, which is led by the Commission, provides best practice strategic and operating principles and guidance for national CQR regarding governance arrangements, current registry logical design and infrastructure, reporting capability, approach to outlier management and data security arrangements.
In 2020, the Australian Government Department of Health and Aged Care (the Department) released the National Clinical Quality Registry and Virtual Registry Strategy 2022-2030 (the Strategy), endorsed by all jurisdictions. The National Strategy, which is led by the Department, provides a series of actions for governments, registries, and other stakeholders to build capacity and efficiency in line with the Framework 2nd edition, and support adoption of broader digital health and other key health reforms.
In 2023, the Commission released the revised draft Framework Second Edition consultation version which aimed to strengthen guidance that better supports organisational oversight, CQR design, management and operations. The development of a corresponding CQR quality Standard will further strengthen the guidance provided by the Framework, to support successful implementation.
In 2024, the Commission released the revised Australian Framework for National Clinical Quality Registries 2024 to strengthen guidance that better supports organisational oversight, CQR design, management and operations.
You can request a copy of the consultation version of the Framework for Australian clinical quality registries – Second Edition by emailing the Commission via CQR@safetyandquality.gov.au.
Governance, accreditation, and quality assurance of review
In 2020 the Commission engaged the Rosemary Bryant AO Research Centre to undertake a review of the processes that exist or are recommended for clinical quality registry (CQR) governance, accreditation and quality assurance internationally and in Australia. The findings helped inform the Commission’s revision of the Framework for Australian clinical quality registries.
The Evidence Check included 26 studies and a review of country approaches to CQRs. The key findings include:
- Complete, high quality CQR data capture at a health system level is best achieved when data collection fits within existing reporting structures and is facilitated by national digital hosting capability. This includes contemporary database technology and quality assurance processes and national accreditation of CQRs.
- Successful national CQRs have organisational governance arrangements; receive some government funding and are coordinated between national, state and territory governments and stakeholder groups.
- Internationally, there is evidence of central CQR organisation(s) that: collect and analyse data for numerous databases; provide expertise and a skilled and reliable workforce; establish linkage with other national datasets and have established auditing and quality assurance systems.
- In general, national CQRs, irrespective of the ownership model (government led and funded; stakeholder led and government funded and stakeholder led and funded) ensure peak bodies and/or expert clinicians: advise on clinical indicators; include consumer participation in oversight committees; report benchmarks to health services and monitor outcomes; include public reporting of clinical outcomes and hospital performance; facilitate continual access to, or ownership of data by health services to facilitate continuous quality improvement; provide access to data for clinicians and patients; provide access to product information for implant manufacturers and allow data to be accessed with permission for research.
Access the Evidence check: governance, accreditation and quality assurance of clinical quality registries report below.
Legislation and regulation
As part of the Commission's work to revise the Framework for Australian clinical quality registries (the Framework), the Commission engaged MinterEllison to undertake a review of the Commonwealth, state and territory privacy laws and other relevant legislation that relate to the operation of clinical quality registries (CQRs) including how health data are stored, managed and shared for reporting on clinical outcomes. The review process and findings are provided in the report, Legislation and regulation relating to clinical quality registries.
The report, prepared by MinterEllison:
- Summarises the privacy legislation and regulatory considerations for CQR custodians in each Australian jurisdiction
- Identifies the role and function of data custodians; how health data is stored and shared; in what formats health data should be stored and the length of time data collected for the purpose of research should be held for
- Describes the requirements for establishing a CQR as a quality assurance activity or within a research framework.
Access the Legislation and regulation relating to CQRs report below.
Economic evaluation
The Commission engaged Monash University and Health Outcomes Australia to evaluate the economic impact of five Australian clinical quality registries. Using a conservative methodology, the evaluation study showed that Australian clinical quality registries have delivered significant value for money, when correctly implemented and sufficiently mature.
Evaluation results
Substantial benefits were measured, including:
- Greater survival for patients
- Improvements in quality of life after treatment
- Avoided costs of treatment or hospital stay.
The study found that:
- Benefit to cost ratios ranged from 2:1 to 7:1 – meaning that for every dollar spent, the return on that investment ranged from $2 to as much as $7
- The return on investment could range from $4 if national coverage were achieved by all five clinical quality registries
- Not every clinical quality registry will be cost-effective. Problems such as low coverage, inadequate reporting and inadequate collection of information about patient outcomes will limit the effect of clinical quality registries, and their value to the health system.
Access the Economic evaluation of CQRs report below.
