The Department of Health today announced that it has completed its investigation into an untoward event that occurred at Heal Fertility, a day procedure centre in Central, in accordance with the Private Healthcare Facilities Ordinance.
Under the department’s direction, the centre has implemented a series of measures to prevent the recurrence of similar incidents and ensure strict compliance in the future with the Code of Practice for Day Procedure Centres under the ordinance. This requires reporting of any “serious untoward event” to the DH within 24 hours of identification.
In early July, the department revealed that the centre had breached the code of practice by failing to report to it within the stipulated timeframe after identifying an error in embryo biopsy specimens sent for laboratory testing.
Upon learning of this, the department immediately deployed staff to the centre to investigate. It instructed the centre’s person-in-charge to submit an investigation report within four weeks.
The centre was also required to implement a series of improvement measures, including immediately suspending acceptance of new cases for reproductive technology procedures and making appropriate arrangements for individuals receiving relevant services at the centre.
On July 7, the Council on Human Reproductive Technology suspended 14 out of 17 licensed treatment services provided at the centre, allowing only three services relating to the storage of gametes or embryos to continue pending the investigation’s completion.
The department received the centre’s report, which covered immediate measures and long-term improvement plans, on July 29. The centre has also implemented several remedial measures relating to the handling and storage of embryos and embryo biopsy specimens.
The department has concluded that the centre was non-compliant with the code of practice, with regard to the timely reporting of serious untoward events.
Accordingly, the department has issued regulatory requirements and reminded the centre that it must report such events within 24 hours of identification.
The department highlighted that the centre has revised its procedures and reporting forms to ensure staff compliance with requirements under the code of practice going forward. The department will continue to monitor the effectiveness of these measures.
It also noted that the council convened a special meeting yesterday to review the report by its investigation committee and discuss matters related to the licence issued under the council.
The council has instructed the centre to implement further remedial measures as it considered that there is still room for further enhancements to the centre’s overall performance and operational arrangements.
The council will issue a letter to the centre today to notify them of the requirements. Its investigation committee will re-inspect the premises.
Until the council makes a decision on the licensing matter, the centre may only continue to provide the abovementioned three storage services for gametes or embryos.
Meanwhile, the council will commence its review of the Code of Practice on Reproductive Technology & Embryo Research. This will include reviewing the incident reporting mechanism and optimising the security and handling procedures for biological samples, with a target completion date of next year.
Given that the incident may involve intentional unlawful conduct by an individual, a Police investigation is ongoing.
The department has reminded the centre to strengthen security measures and will maintain close liaison with the Police Force.
