Regulator imposes tough new rules on Monash IVF after embryo transfer error
Victoria’s new IVF watchdog has hit Monash IVF with strict conditions after a shocking mix-up in which staff incorrectly transferred the wrong embryo to a patient.
Victoria’s new IVF regulator has slapped new conditions on Monash IVF’s license after they transferred the wrong embryo to a patient in June.
The conditions — which include reporting to the health department, undertaking actions to confirm “the intended biological sources for each cycle” and “witnessing and checking requirements” — were announced by the Victorian Health Regulator on Friday.
The regulator said they decided to impose conditions after they had “concluded their investigation into the Clayton incident”, referring to an embryo bungle that saw staff transfer a woman’s own embryo — instead of her partner’s as intended — in June.
“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,” the health regulator said in a statement.
Monash IVF said in a statement to the ASX that 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”.
Monash IVF said the company had already implemented the process changes required after their own internal investigation and a review, which they commissioned, from barrister Fiona McLeod into this incident and a second embryo bungle in Brisbane.
The Herald Sun revealed in April this year that Monash IVF was investigating a horror mix-up in Brisbane, which saw a woman unknowingly give birth to a stranger’s baby.
The Victorian Health Regulator said Monash’s conditions would 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”.
“As part of the investigation, the Health Regulator met with Monash IVF on multiple occasions, conducted site inspections and issued information and document production notices which Monash IVF has complied with.”
Monash IVF said the company did not expect the conditions to have a “material impact on its existing operations” or their earnings guidance published earlier this month, which predicted the company would make an underlying net profit after tax “at the bottom end of the $20m-$23m range”.
“The Company will continue to prioritise the care and safety of its patients and will keep ASX informed of any material developments in accordance with its disclosure obligations,” the ASX statement said.
Margalit Injury Lawyers Managing Principal Michel Margalit said the firm continued to receive heart-wrenching claims of substandard IVF treatment – from a variety of providers across Australia.
“Regulatory reform is desperately needed to protect aspiring families from further heartbreak,” she said.
Originally published as Regulator imposes tough new rules on Monash IVF after embryo transfer error
