Monash IVF hit with strict new rules from health regulator after embryo mix-up

The embattled fertility service will be subject to strict conditions imposed by the Victorian Health Regulator in the wake of an embryo bungle.

Monash IVF will now have conditions imposed on its operating licence in Victoria

Scandal-plagued fertility service Monash IVF has been hit with a raft of new conditions on its registration by the Victorian Health Regulator in response to an embryo mix-up.

Monash IVF was first plunged into controversy in April when it was revealed to have falsely implanted an embryo from the wrong couple into a woman at its Brisbane clinic.

The mistake went unnoticed for at least five months until after she had already given birth to the child, which bore no genetic relation to her.

That mix-up was the first of its kind in Australia. Then two months later Monash IVF revealed it had mistakenly transferred the wrong embryo into another patient in Clayton, Victoria, implanting a woman with her own embryo, rather than her partner’s.

Both incidents were attributed to “human error” by Monash IVF.

Monash IVF has attracted multiple external investigations. Picture: 9News

The second failure prompted an investigation by the Victorian Health Regulator, which reported on Friday.

“Victoria’s Health Regulator has concluded its investigation into Monash IVF Group Ltd following an incident that occurred at its Clayton laboratory on 5 June, where a patient’s own embryo was incorrectly transferred to that patient, contrary to the treatment plan which designated the transfer of an embryo of the patient’s partner,” the departmental statement reads.

“The Health Regulator has determined to impose conditions on Monash IVF’s registration.

“These conditions will remain in place until the Health Regulator is satisfied the risks identified, as the result of its investigations into the incident, are effectively mitigated and Monash IVF has demonstrated sustained compliance.

“The conditions focus on matters such as ensuring the integrity and traceability of genetic material through comprehensive consent and documentation processes, rigorous verification and patient checks, accurate recording in management systems, and strengthened staff capability,” it says.

Monash IVF said in a statement to the ASX it did not “expect that the conditions will have a material impact on its existing operations, nor does it expect them to have a material impact on the company’s earnings”.

“The process changes required under the conditions have already been implemented by the company through the introduction of enhanced safety protocols following the company’s internal investigation.

“The conditions include specific actions and obligations relating to the process for confirming the intended biological sources for each cycle; requirements relating to the company’s patient management system, witnessing and checking requirements and record keeping; and staff education and training, periodic auditing and reporting to the Victorian Department of Health.

“The company will continue to prioritise the care and safety of its patients.”

Monash IVF in August announced it had completed an independent review into both mix-ups, but refused to release the full findings.

The health firm is being circled by potential buyers, last week refusing a $312m takeover offer from private equity firm Genesis Capital and investment house Washington H Soul Pattinson. It dismissed the “opportunistic, unsolicited” bid as an undervaluation.

The company’s shares are down more than 46 per cent in the past 12 months.

Monash IVF courted controversy five years earlier when flawed genetic testing led hundreds of patients to destroy potentially viable embryos. It prompted a class-action lawsuit from 1300 affected customers and patients, which last year reached a $56m settlement, under which Monash IVF made no admission of wrongdoing.

Margalit Injury Lawyers managing principal Michel Margalit represented affected customers in the class action, and said the ongoing failures pointed to a regulatory blind spot.

“We query why it has had to come to further tragedy for these regulations to only now be imposed. We query whether these newer cases of harm could have been avoided had the Health Regulator acted earlier,” Ms Margalit said.

“Regulatory reform is desperately needed to protect aspiring families from further heartbreak.”