An IVF clinic accused of using the wrong sperm to create children has been asked to destroy thousands of frozen semen samples because it cannot guarantee it has not mixed-up others.
An audit of Queensland Fertility Group (QFG) semen samples frozen before 2020 found thousands to be at high risk of misidentification because of a lack of double witnessing, a report by the state's health ombudsman says.
Double witnessing is common in health settings to potentially identify errors and improve patient safety.
Health Ombudsman Lynn Coulson Barr's confronting report into the state's 24 licensed fertility providers, ordered by Queensland Health Minister Shannon Fentiman, notes that for QFG sperm donations after 2021, 96 per cent of vials were rated as low risk.
"However, this still leaves 4 per cent of vials that were deemed to be medium or high risk," the 135-page document says.
It follows an ABC Four Corners investigation into Australia's lucrative IVF industry that's found when things go wrong corporate giants like QFG don't always own up. There's a lack of transparency and companies aren't being held to account by the industry-funded regulator.
Among the cases highlighted is that of Anastasia and Lexie Gunn and their three sons who were conceived using donor sperm at QFG between 2006 and 2014.
The couple paid for the same donor to be used for each child, but DNA testing shows their eldest son is not biologically related to their two younger boys, who both have serious health conditions.
QFG has maintained its records show the same donor was used for all three children.
"It's been lie after lie, excuse after excuse. They knew what they had done and just hoped we would just give up and go away," Anastasia Gunn said.
"They owe our children an apology."
Incorrect labelling not reported
In her report, Dr Coulson Barr found that issues relating to the appropriate collection, storage and identification of sperm samples continue to persist.
The ombudsman recommended the Reproductive Technology Accreditation Committee (RTAC) of the Fertility Society of Australia and New Zealand ensures that all assisted reproduction providers dispose of stored donor material that fails to meet current identification standards.
Clinics are not named in the report, but the ABC understands QFG, one of Australia's biggest fertility clinics, is identified in the document as Provider E.
The report found some QFG adverse events — such as incorrect labelling of frozen semen — were not reported to RTAC, the industry regulator.
Dr Coulson Barr said the Office of the Health Ombudsman (OHO) had identified gaps and risks in the level of oversight and independence that RTAC had in the performance of its role in the "self-regulatory regime in Queensland".
Her report highlighted a "certificate of agreement" between QFG and the Fertility Society of Australia and New Zealand (FSANZ), which resulted in heavily redacted audit data being provided to the OHO.
"This certificate required that Provider E and FSANZ mutually commit to uphold the confidentiality of the contents of the audit reports," Dr Coulson Barr wrote.
She said the issue raised significant concerns about the ability of the regulator to provide independent oversight and transparency of the provision of assisted reproduction services in Queensland.
Calls for transparency
Former QFG patient Danielle Patorniti said the agreement showed the national regulator was not independent.
"I complained many times to RTAC and sometimes my complaint wasn't even acknowledged," she said.
Ms Patorniti spoke out in the Four Corners investigation about QFG's failure to warn other families of a donor's potential genetic issues.
"It's definitely a mixed bag of emotions but I'm glad the truth is now out, and families can get the support and protection needed," she said.
Anastasia and Lexie Gunn agreed.
"I'm ropeable about the 'certificate of agreement'," Lexie said.
"RTAC is the organisation that decides who can get millions of dollars of taxpayers' Medicare money."
Anastasia added: "The best thing that could happen now would be if every document, every letter, was brought out into the public eye.
"Only by seeing the whole truth — no matter how bad it is — can we all start to heal."
Minister 'shocked'
Queensland performs about 21 per cent of fertility treatments in Australia. The sector is self-regulated.
But in June, the Miles Government introduced legislation to regulate the assisted reproduction industry in Queensland, which will include a donor conception information register.
In a statement, Ms Fentiman said the legislation would provide more powers to Queensland Health to oversee providers.
"I would like to acknowledge the courage of the people who shared their personal experiences as part of this report, and those that have reached out to me directly who have advocated for change," she said.
"We really have had, for a number of years, a real lack of regulation for these providers.
"I was shocked when these families came to speak to me, which is what prompted me to ask the health ombudsman to begin her work."
Dr Coulson Barr acknowledged in her report the huge impact of gamete mix-ups on families.
"The trauma and distress associated with these cases has been evidence in the complaints made to the OHO," she wrote.
"Appropriate counselling should be offered by … providers to ensure that consumers and their families are given appropriate support to manage the emotional turmoil created with uncertainty about paternity and genetic origins.
"The implications for families from such errors are life long."
Comment was sought from QFG.
FSANZ failed to answer the ABC's questions about its "certificate of agreement" with QFG and whether this was an impediment to its ability to act independently as the regulator.
In a statement it said, "FSANZ continues to advocate for comprehensive, Australia-wide legislation for the IVF and ART (assisted reproductive technology) sectors. This unified approach aims to establish consistent standards and practices across all states, addressing the discrepancies identified in the OHO report and enhancing the safety and effectiveness of ART services nationwide."
Anastasia Gunn said the OHO report was a horrible confirmation of what she suspected to be true all along.
"I ended up crying because every page was worse than the one before it. The things they have done to patients – vulnerable patients who trusted them with their bodies, hopes and dreams – are disgusting," she said.