Reporting serious assisted reproductive technology adverse events

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.