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 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.
The investigation, and subsequent enforcement action, was carried out under the Assisted Reproductive Treatment Act 2008.
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.
The Health Regulator will continue to monitor all registered Assisted Reproductive Treatment (ART) providers for compliance with the Assisted Reproductive Treatment Act 2008 and the Assisted Reproductive Treatment Regulations 2019.
