The Council on Human Reproductive Technology has accepted findings that an embryo-sample incident may have involved an individual’s intentional unlawful conduct, while confirming that no embryo was mixed up or mistakenly implanted. The clinic remains restricted to three services involving the storage of gametes or embryos.
The council suspended 14 of the clinic’s 17 licensed treatment services on July 7 as an interim measure, leaving the three storage-related services operating during the investigation. The incident came to light in early July after embryo samples sent for genetic testing were found not to match the intended parents’ DNA.
The council said the clinic had not taken sufficient protective measures when handling and storing samples and that its overall operations required improvement. The findings were accepted at a special meeting on September 4.
The Department of Health also found that the clinic breached the Code of Practice by failing to report a Serious Untoward Event within the required timeframe. The reports said the clinic did not make the report within 24 hours of identifying the error.
The Department of Health received the clinic’s investigation report on July 29, after ordering management to submit one within four weeks. The clinic has since revised its internal reporting procedures and forms, and the department said it would monitor whether the changes are effective.
The council has issued specific remedial requirements and plans another on-site inspection. It will decide on the clinic’s licence after obtaining further information, while the clinic continues to be limited to the three storage services. The council is also reviewing its Code of Practice, including incident reporting and the security and handling of biological samples, with the aim of completing the work the following year.