Health Ombudsman investigation report into health services delivered by assisted reproductive technology (ART) providers in Queensland
01 July 2024
The Office of the Health Ombudsman (the OHO) has completed its investigation into health services delivered by 24 licensed assisted reproductive technology (ART) providers in Queensland.
The investigation of ART providers in Queensland was undertaken in response to the direction of the Minister for Health, Mental Health and Ambulance Services and Minister for Women, the Hon Shannon Fentiman MP (the Minister) under section 81 of the Health Ombudsman Act 2013.
This investigation provided an important opportunity to independently review the quality and safety of services within a health sector that can offer so many benefits to consumers through the creation of a family that may otherwise not have been possible. It also shone a light on the experiences of consumers receiving ART services and the gravity of impacts on consumers, donors and donor-conceived people when things go wrong.
The initial scope of the investigation examined identified issues, non-compliance or adverse events associated with:
- the handling of gametes and embryos, including collection, labelling, storage and transportation;
- screening of gametes and embryos used in Queensland;
- record keeping and provision of information; and
- maximum donation and distribution of gametes within Australia.
In March 2024, after further issues were identified, the scope of the investigation was broadened to consider:
- whether adequate information is made available to consumers, to allow them to provide informed consent when choosing ART treatment;
- issues related to the quality of donated sperm and impacts on choices of ART treatment;
- use of sex selection in accordance with the National Health and Medical Research Council (NHMRC) Guidelines; and
- issues associated with discarding of gametes and/or embryos (genetic or biological material).
The OHO reviewed current and closed complaints and enquiries received about health services provided by licensed ART providers in Queensland, as well as records related to compliance with the Fertility Society of Australia and New Zealand (FSANZ) Reproductive Technology Accreditation Committee (RTAC) Code of Practice and the NHMRC Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice. Incident and adverse event reports, accreditation audit reports, and complaints made to ART providers were also examined.
The OHO also considered the following themes identified from the analysis of complaints and information obtained for this investigation:
- current mechanisms for the oversight of ART services and applicable standards;
- open disclosure and the management of complaints and adverse events by ART providers;
- impacts on consumers identified in responses to complaints and adverse events.
The OHO’s investigation identified significant systemic issues relating to the provision of ART services, including gaps and risks in the current self-regulatory regime in Queensland. The OHO found that these issues indicate a compelling case for the need for proposed legislation to regulate ART providers in Queensland and to strengthen the safeguards for consumers, donors and donor-conceived people.
The OHO was pleased to also identify improvements in practices and technological advancements which are being implemented by ART providers and FSANZ-RTAC to address historical issues, and that there was broad support for the proposed regulation of ART services in Queensland and the establishment of a donor conception register.
The OHO has made detailed recommendations for consideration of the Minister, FSANZ-RTAC and ART providers on ways in which the issues identified in this investigation can be addressed. The OHO believes that the implementation of these recommendations will improve the quality and safety of ART services and provide trust and confidence in these services for all Queenslanders.
Addendum 5 July 2024
The Health Ombudsman notes some media coverage of this report has incorrectly referred to the Health Ombudsman ordering the destruction of large numbers of frozen sperm donations at risk of misidentification. The Health Ombudsman has not made such an order and does not have the power to do so. The relevant findings and recommendations relating to ‘the appropriate collection, storage, identification and distribution of gametes and embryos’ are found at pages 35 to 40 of the report, and the full report provides the context for these findings and recommendations.