Reporting serious assisted reproductive technology adverse events

Licensed fertility providers are required, under the Human Reproductive Technology Directions 2021 (external site), to report adverse events to the Chief Executive Officer of the Department of Health.

Adverse event reporting is also required under the Fertility Society of Australia and New Zealand Reproductive Technology Accreditation Committee (RTAC) Code of Practice for Assisted Reproductive Technology Units (external site).

Licensed facilities will also have adverse event reporting obligations under other legislation.

A serious adverse event report (external site) must be submitted by the licensee within 7 days of the incident.  A subsequent report outlining investigation outcomes and recommendations must be submitted within 6 weeks of the incident.

A serious adverse event report is required in case of the following:

  • a medical or surgical condition resulting from assisted reproductive technology (ART) procedure;
  • an ART participant is hospitalised for more than 24 hours;
  • suspected or confirmed communicable disease transmission;
  • potential or confirmed legislative breach (including five donor family limit);
  • gamete or embryo mix-up;
  • loss of viability, or suspected deterioration, of gametes or embryos; or
  • systemic failure of a diagnostic test.

The Assisted Reproductive Technology Adverse Event Reporting Guideline (PDF 639 KB) provides additional information on reporting requirements.

More information

Reproductive Technology Unit

Mail to: PO Box 8172, Perth Business Centre, WA 6849