The Health and Disability Commissioner has slammed a fertility company after losing a man's sperm.
In findings released on Monday afternoon, Deputy Health and Disability Commissioner Dr Vanessa Caldwell found Fertility Associates breached the Code of Health and Disability Services Consumers' Rights (the Code) when it lost a customer's sperm.
Dr Caldwell provided a scathing review of Fertility Associates saying the company's policies were unable to detect what staff had lost the sperm and if they had the necessary skills and training.
Following chemotherapy, the man placed a sample of sperm in a storage facility which was later bought by Fertility Associates.
But the clinic was later unable to find the man's sperm samples during the IVF process with the man and his partner. A testicular biopsy confirmed the man had no remaining sperm that could be used for IVF, according to Caldwell.
This resulted in Fertility Associates undertaking an internal investigation, which found the last time the man's sperm samples were known to be in its possession was seven years prior.
Fertility Associates concluded the samples were most likely lost because staff didn't follow policy and undertake an inventory check when the storage bank holding the samples was decommissioned.
Dr Caldwell, after careful consideration, concluded due to poor record keeping there was insufficient information to conclude the most likely reason the samples went missing.
Even though Fertility Associates' policies may have been appropriate, Dr Caldwell pinpointed shortcomings in record-keeping and audit systems that could have assisted identification of how the samples were lost.
The presence of a policy was an insufficient reason to conclude adequate safeguards were in place to prevent the loss of the samples, Dr Caldwell found.
She believes staff needed to be aware of the policy and supported to follow it, and there needed to be adequate monitoring in place to identify gaps.
Fertility Associates were also unable to identify which staff were involved, what steps were in place to ensure they had the necessary skills and training, and how the policy was monitored, Dr Caldwell found.
Dr Caldwell found Fertility Associates breached Right 4(1) of the Code 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, 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," she said.
"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."
Since the complaint, Fertility Associates has made several changes, including:
- Apologising to the man and his partner.
- Implementing the practice of splitting patient samples between multiple locations for fertility preservation samples in certain circumstances.
- Introducing a new policy that requires all working documents relating to the retirement of a bank to be retained for seven years, to allow Fertility Associates to check that an audit was completed at the decommissioning stage, and to assist in investigations into any future lost samples.
- Updating its auditing tool for retiring storage banks, and including reporting on retired banks as part of routine auditing.
- Changing its policies to require an incident report to be raised when any sample is not in the location recorded in its record.
Dr Caldwell acknowledged Fertility Associates has already apologised to the man and his partner and recommended they:
- Report to HDC on any decommissioned banks and provide details of audit documentation to show that the relevant processes were followed.
- Engage an expert in the field of cryogenic storage facility management to review its systems and processes to identify any storage risks that are not mitigated sufficiently.
- Provide evidence that its sample storage consenting documentation has been updated to inform consumers of its physical auditing processes and the possibility of sample loss. Storing samples over 10 years of age in designated banks, and verifying the presence of stored samples before the owner is asked if they intend to extend storage.
