Reportable events
Under the ART Act, ART providers are required to report certain events. This allows appropriate oversight and compliance and regulatory action by Queensland Health, if required.
Reportable events are categorised as either:
- serious adverse events (SAE)
- other reportable events.
Reporting these events within specified timeframes is mandatory.
Serious adverse events
SAEs are defined in the Reproductive Technology Accreditation Committee Code of Practice for Assisted Reproductive Technology Units (Accreditation Standard).
| Event | Notice period |
|---|---|
| Significant surgical or medical condition | 7 Days |
| Hospitalisation | 7 Days |
| Transmission of a communicable disease | 7 Days |
| Legislation breach | 7 Days |
| Gamete or embryo identification error | 7 Days |
| Loss of viability of gametes or embryos | 7 Days |
| Testing or diagnostic failure resulting in misdiagnosis and/or significant harm | 7 Days |
Other reportable events
A range of other reportable events also have specified notice periods.
Event | Notice period |
|---|---|
| The ART provider acted without the written consent of the ART user | 7 days |
| The ART provider acted in a manner inconsistent with the ART user's written consent | 7 days |
The ART provider reasonably believes laboratory practices do not meet accepted industry standards, and this has caused, or could cause, harm to:
| 7 days |
ART services are disrupted due to events such as a natural disaster, power outage, equipment failure, or cyber-attack and:
| 7 days |
An associated entity operating in another Australian state has:
| 7 days |
| ART provider stops having prescribed accreditation | 14 days |
| ART provider’s prescribed accreditation changes | 14 days |
| ART provider stops providing ART services | 14 days |
| ART provider contravenes a condition on its licence (general or specific) | 14 days |
| ART provider changes the premises at or from which ART services are provided | 21 days |
| Change in the medical practitioner who performs or supervises the performance of an ART service | 21 days |
| Change in any of the prescribed personnel who are engaged by the ART provider to deliver ART services | 21 days |
| Changes of ownership or business structure (significant corporate changes) | 21 days |
Delivering ART services without consent
This applies if an ART provider does something that requires consent but does not obtain it beforehand or if an ART provider has consent but undertakes a procedure or other ART service inconsistent with the consent.
For example, an ART provider mistakenly uses the consent from a previous cycle as the consent for the current cycle, failing to obtain a new consent for the current cycle. This would be acting without consent and is a reportable event.
Laboratory practices that are substandard or result in harm
This event applies if a licensed provider reasonably believes their laboratory practices do not meet industry standards or could result in physical or psychological harm to a person provided with ART services or a person born as a result of an ART procedure.
For example, a laboratory discarded all remaining embryos for the incorrect patient which resulted in psychological harm to the patient receiving ART services. Due to the psychological impact to the patient and the laboratory practices being considered sub-standard, it is a reportable other event.
Unplanned disruption to business services
Business disruption could result from a natural disaster, equipment failure, cyberattack, or other event that is generally outside of the ART provider’s control. These events can still have, or there is potential for them to have, a serious impact on a person provided with ART services or a person born as a result of an ART procedure. These events are reportable to allow for monitoring of the ART provider's response.
Cancellation, suspension or prohibition of associated entity in another state
This applies if an associated entity (including subsidiaries) has its licence (or equivalent authorisation) to provide ART services cancelled or suspended in any other state or territory of Australia.
Changes to accreditation or services
Accreditation stops
ART providers must report if they no longer have accreditation. If an ART provider stops having prescribed accreditation, their licence to provide ART services must be suspended or cancelled.
Change to accreditation
Changes to accreditation are reportable. For example, an ART provider receives an accreditation report with some actions recorded as ‘met with recommendations’ and several ‘not met’. The ART provider has a set timeframe to rectify the ‘not met’ actions. The provider must report receiving notice of the accreditation outcomes.
ART services stop
A provider must report if it ceases to provide ART services altogether. For example, if a provider goes into voluntary administration, and all premises are closed. The provider should report the clinic closures and the arrangements for the safe transfer of stored sperm, eggs or embryos to another clinic. In practice, given the potential significance for persons using this provider, reporting would be expected earlier than the 21 days required.
Contravention of licence conditions
An ART provider must notify Queensland Health of any contravention (breach) of a licence condition within 14 days. This can include the breach of a general or specific licence condition.
Scenario: Breach of licence condition
A condition relating to non-contact disposal may be placed on an ART provider's licence. This condition states the ART provider is required to dispose of sperm, eggs or embryos within 12 months of confirming they have lost contact with the person entitled to use the sperm, eggs or embryos.
During a routine compliance monitoring activity, a designated tank of ‘lost contact’ sperm that met the requirements of the licence condition but had not yet been discarded was discovered. The ART provider should still report the event within 14 days.
Change in premises
A premises is defined as a location where supporting services (i.e. counselling) are carried out, which includes but is not limited to practice rooms, day hospitals, and telehealth sites.
Changes in premises that require reporting include:
- temporary or permanent relocations from one premises to another or within the same broader location, e.g. to another suite in the same hospital
- temporary relocations that impact on the provision of ART services or the use of sperm, eggs, or embryos, e.g. opening consultation rooms in a demountable structure on the same premises because of renovations
- new or no longer used premises.
Changes to premises interstate also need to be reported. For example, where counselling services are provided via telehealth with the counsellor located in another Australian jurisdiction. If this counsellor was to change premises this would be a reportable event.
Change in personnel, including supervising medical practitioner
Personnel covers two categories of people:
- key personnel are the Medical Director, Scientific Director, Nurse Manager, Counselling Manager or Senior Counsellor, and Quality Manager or Coordinator
- additional personnel include the Clinical Director, Laboratory Manager or Supervisor, Nurse Unit Manager or Senior Nurse, and Counsellor.
Any changes to either key personnel or additional personnel are reportable within 21 days. There are situations where Queensland Health does not need to be notified. For example, where a Nurse Manager goes on annual leave for a week and is backfilled by a current member of staff. However, if the Nurse Manager goes on annual leave for a period of 3 months or more, this would be a reportable event.
Changes in ownership or business structure
Changes in ownership or business structure, such as a merger, are reportable within 21 days.
Providers can contact ART@health.qld.gov.au for further guidance on reporting requirements.