Queensland’s health ombudsman has ordered the destruction of thousands of frozen sperm donations, as a new report reveals 42% of all audited samples in the state were of medium or high risk of being misidentified.
The state had more than twice as many potential errors identified in audits as the next worst state, Victoria.
Examples or errors included “identification mix-ups, loss of viability of gametes or embryos, and suspected deterioration beyond laboratory standards,” the Office of the Health Ombudsman found.
“Some incidents, such as incorrect labelling of frozen semen and unclear labelling of straws, were not reported” to the regulator by one provider “potentially indicating lapses in reporting protocols,” the report found.
It recommended that all clinics in the state “dispose of stored donor material not meeting current identification standards” and compliance be required in future audits.
It is unknown exactly how many donations would be destroyed, but the ombudsman found there were “thousands” of samples frozen before 2020 that were at high risk due to lack of double witnessing discovered in an audit at just one clinic.
The purge will add to an already significant shortage of donated sperm in Australia.
“The impact on consumers and the donor-conceived children in cases of gamete mix-ups cannot be underestimated,” the report found.
“Appropriate counselling should be offered by ART providers … to manage the emotional turmoil created with uncertainty about paternity and genetic origins. The implications for families from such errors are lifelong.”
The ombudsman found that errors in the industry continue to persist up to the present day.
At one clinic 4% of material gathered since 2021 was of medium or high risk of misidentification, the report found.
One facility had not undertaken an identification and traceability internal audit within the last 12 months, it found.
Double witnessing is a basic health check conducted even on simple procedures like a saline drip.
Anastasia Gunn is suing a Queensland fertility provider because she alleges she was provided the wrong sperm in 2014. She believes her eldest son isn’t related to his two brothers.
“We are horrified, but not surprised, that thousands of sperm samples were not double-checked before 2020,” she said on Tuesday.
“It is scary to think how many patients may have unknowingly conceived with the wrong sperm.
“We are probably just one family of many that this has happened to. Why were the clinics not double-checking when they were making humans? The effects of these errors last for generations.”
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The report also found the state’s industry had used very low-quality sperm, had failed to report errors, or delayed doing so, and had delayed informing one pregnant patient for several weeks that the wrong sperm had been used, among other errors.
Other reported errors included the use of sperm stored for more than a decade, loss of the last sample of a consumer’s sperm, use of an embryo without donor consent, a temperature gauge malfunction resulting in an unviable embryo and more.
In one case a provider had identified sperm samples at “high risk” of misidentification but had taken no action to remove them from use for “at least” three years by either the clinic or the regulator until the intervention of an external auditor.
Queensland has one of the country’s biggest fertility industries, performing about 21% of all Australian fertility treatments at 24 listed providers. It is self-regulated, with no state laws applying to the sector.
The Fertility Society of Australia and New Zealand supported the recommended purge, but warned it could cause “significant pushback from recipients who are unable to complete their families with the existing donor material”.
The ombudsman recommended that the society’s Reproductive Technology Accreditation Committee – which regulates the industry – be responsible for implementing the purge.
A spokesperson for the society said “RTAC does not have the enforcement authority to undertake such an action … under current law, responsibility for compliance lies with individual clinics”.
An expert told the inquiry the most likely reasons for errors included insufficient processes, inadequately trained or overworked staff, not enough staff, and time pressures.
The health minister, Shannon Fentiman, said the government welcomed the ombudsman’s findings and recommendations.
“It is paramount that we protect the interests of consumers and donor-conceived individuals,” she said.
In May, the Miles government introduced legislation to regulate Queensland’s fertility industry, including severe punishments for failure to report errors.