An embryologist removes straws used for embryo or semen storage from the storage tanks at a Fertility Associates clinic. Photo / Michael Craig
An embryologist removes straws used for embryo or semen storage from the storage tanks at a Fertility Associates clinic. Photo / Michael Craig
Fertility Associates lost a man’s sperm which had been collected for use in in-vitro fertlisation (IVF) as he underwent chemotherapy for cancer.
Tests later confirmed that the man no longer had any sperm that he and his partner could use to try to conceive a baby through IVF.
Deputy Healthand Disability Commissioner Dr Vanessa Caldwell has found the company, which has 22 fertility clinics nationwide, breached the male consumer’s rights by losing the sperm.
Caldwell said in a report released on Monday that, following chemotherapy some years ago, the man placed a sample of sperm in storage in a facility later bought by Fertility Associates.
The egg retrieval from Ms A, conducted before the loss of the sperm was discovered, had been a “long and difficult process”.
He had complained to the company and engaged in mediation but he still had concerns about the company’s processes.
The report said Fertility Associates carried out an internal investigation and found that the last time the man’s sperm samples were known to be in its possession was in 2011.
“After considering potential causes for the loss, Fertility Associates concluded the samples were most likely lost because staff did not follow policy and undertake an inventory check when the storage bank holding the samples was decommissioned,” Caldwell said.
She said there was insufficient information to make a conclusion on the most likely cause of the sample loss “due to poor record-keeping”.
There were two possible times when Mr A’s samples could have been handled before it was discovered they were missing in 2018.
One was in 2015, when the storage bank containing Mr A’s samples was decommissioned.
The second was in 2017, when the canister storing the samples was emptied and the contents relocated.
Deputy Health and Disability Commissioner Dr Vanessa Caldwell said Fertility Associates had a responsibility to ensure the safe storage of samples in its possession.
Fertility Associates were unable to identify which staff were involved, what steps were in place to ensure that they had the necessary skills and training, and how policies around the storage of samples were monitored.
Caldwell found Fertility Associates breached the Code of Health and Disability Services Consumers’ Rights for failing to provide services with reasonable care and skill.
“I acknowledge that loss of samples is a rare and devastating risk to assisted reproductive technologies,” Caldwell said. “However, I am critical that Fertility Associates lost the man’s sperm samples, and that its systems were unable to provide evidence of how or when the loss occurred.
“Fertility Associates has a responsibility to ensure the safe storage of samples in its possession and to have robust systems in place to prevent loss occurring.”
Caldwell said that, since the complaint, Fertility Associates had undertaken a number of actions, including apologising to Mr and Ms A.
It had begun splitting patient samples between multiple locations, and introduced a new policy that required all working documents relating to the retirement of a bank to be retained for seven years.
This would allow Fertility Associates to check that an audit was completed at the decommissioning stage, and to assist in investigations into any future lost samples.
It was also updating its auditing tool for retiring storage banks, and including reporting on retired banks as part of routine auditing.
In future, it would require an incident report to be raised when any sample was not in the location recorded in its record.
Caldwell recommended that the company also engage an expert in cryogenic storage facility management to review its systems and processes, and provide evidence that its consenting documentation has been updated to inform consumers of its physical auditing processes and the possibility of sample loss.
Fertility Associates has been approached for comment.
In its responses to the commissioner, it said that no system could prevent all human error, and it would be “unreasonable” for the commissioner to expect perfection.
It told the commissioner that, similarly to other areas of medicine such as radiology, “it is provable from data and well-established that a certain error rate is inevitable”.
It said that rate was very low for assisted reproductive technologies.
