Compliance and regulatory actions
We have a scalable suite of compliance and regulatory powers to support the appropriate and proportionate administration of the ART regulatory scheme.
If there is serious risk to the public, we may use any of our compliance and regulatory powers without scaling up.
Supporting continuous improvement
We adopt an education-first approach. We may choose to promote compliance by educating an ART provider about any gaps in their compliance and seeking their commitment to improvement. This step is usually taken before formal regulatory action is needed.
Regulatory powers
Formal regulatory action under the ART Act includes:
- imposing specific conditions on a licence
- issuing an improvement notice
- issuing a prohibition notice for all or some ART services
- suspending or cancelling a Queensland Health ART licence.
Improvement notice
We may issue an improvement notice requiring an ART provider to resolve a particular matter to prevent or reduce a risk to the health, safety, or welfare of people receiving ART services or those born as a result.
We will monitor the provider’s compliance, including making sure any improvement activities are undertaken within the time frame stated in the notice.
Requirements in an improvement notice become a condition on the ART provider’s licence and may be published in the public register.
Scenario: Consent form does not comply with the ART Act
Manju made a complaint saying she was not told about the risks of undergoing an egg retrieval procedure.
We requested a copy of Manju’s consent form from her ART provider. The consent form did not comply with all the requirements under the ART Act and Regulation. We asked the ART provider to voluntarily update the consent form. Despite ongoing discussions, the form was not updated.
An improvement notice was issued requiring the consent form to be changed.
Scenario: Record-keeping does not comply with the ART Act
Gavin made a complaint that some of the pages in his scanned medical record from the ART provider were illegible. Gavin was upset that a page in a treatment plan was fuzzy, and the provider did not have a copy of the original as it was destroyed in line with the provider's record keeping processes. This is allowed under the Act.
We asked the ART provider about their process for checking the quality of scanned documents before destroying originals. Only 20 per cent of treatment plans were checked when scanned as a quality control measure. Although the page was illegible, the information from the page was available in the electronic record management system.
An improvement notice was issued to the ART provider requiring them to develop stronger record-keeping practices and train personnel.
Prohibition notice
We may issue a prohibition notice if a person or provider has:
- contravened a licence condition
- breached relevant ART legislation
- provided services in a way that creates a risk to the health, safety or welfare of people receiving ART services or people born as a result.
Prohibition notices may be limited to specific ART services, such as services of a specific kind, at a stated premises, or provided by particular individuals.
A prohibition notice remains in force until it is revoked. Where a prohibition notice limits specific ART services provided by a licensed ART provider, this becomes a specific condition of the provider’s licence and may be published in the public register.
Scenario: An unlicensed person providing ART services
A journalist was conducting an investigative report into ART services in Roma. When the journalist checked the public register, they could not find the person or their ‘clinic’ name listed.
We confirmed the person did not have an ART licence. They were issued a prohibition notice requiring them to stop all services. Criminal proceedings were brought against the person for breach of the ART Act and they were reported to the Office of the Health Ombudsman.
Scenario: Laboratory monitoring is not maintained within reasonable standards
Laboratory conditions must be tightly controlled to maintain embryo viability. A sudden increase in serious adverse event reports from an ART provider in Goondiwindi indicated a rising trend in embryo viability loss.
We established the ART provider had identified a monitoring system in one section of the laboratory was giving false readings. The false readings were leading to changes in the incubator environment, resulting in loss of embryo viability.
While the ART provider took immediate steps to move embryos to another laboratory, it did not have a contingency plan to quickly rectify or replace the monitoring system. We issued a prohibition notice stopping the use of the incubator. This prohibition remained in place until the faulty monitoring system was fixed and appropriate contingency systems were in place.
Suspension or cancellation
We must suspend or cancel an ART provider’s licence if the provider:
- stops having prescribed accreditation
- is completely banned from providing ART services by a prohibition notice.
We may also suspend or cancel an ART provider’s licence if:
- the licence was granted on the basis of false and misleading information that was critical to the decision to grant the licence
- the provider notifies us it has stopped providing ART services
- a licence or authorisation to provide ART services has been cancelled or suspended in another state or territory
- an associated entity of a provider has been prohibited from providing some or all ART services in another state or territory
- a person or corporation is or has been under voluntary administration or insolvent under administration
- where personnel, as defined by the accreditation standard, involved in providing ART services have ceased to perform their role, and a replacement has not been appointed within 30 days.
Scenario: Interstate prohibition
An ART provider operating in Western Australia, South Australia and Queensland has its licence suspended in Western Australia due to its failure to adequately address an issue in the laboratory. The issue also applies in Queensland.
Queensland Health was notified by the provider about the suspension in WA and the reason for it. These issues are ongoing. The ART provider’s licence in Queensland was suspended until the safety of users of ART could be assured.
Scenario: Unable to appoint replacement personnel as defined by the accreditation standard
The Medical Director at an ART provider retired from practising fertility services on 1 July. The provider is working through the recruitment process. In investigating an anonymous complaint, we determined the position is substantively vacant and will not be filled until at least 30 September, with no one who can backfill the role.
As a Medical Director is considered key personnel by the accreditation standard, and there is no backfill available, we suspended the provider’s licence until a backfill arrangement was established, or a suitable replacement appointed.
Revocation of regulatory action
We may revoke formal regulatory action, including improvement and prohibition notices, suspensions, and cancellations of licences at any time. An ART provider may apply for revocation.