DH completes investigation into Serious Untoward Event involving "Heal Fertility Limited"
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     The Department of Health (DH) announced today (September 4) that it has completed its investigation into the Serious Untoward Event that occurred at "Heal Fertility Limited", a day procedure centre (DPC) in Central, in accordance with the Private Healthcare Facilities Ordinance (Cap. 633) (the Ordinance). As directed by the DH, the DPC has implemented a series of improvement measures to prevent the recurrence of similar incidents and ensure strict compliance in the future with the Code of Practice for Day Procedure Centres (Code of Practice) under the Ordinance, which requires reporting any Serious Untoward Events to the DH within 24 hours of identification.
      
     In early July, the DH revealed that the DPC had breached the Code of Practice by failing to report to the DH within the stipulated timeframe after identifying an error in the embryo biopsy specimens sent for laboratory testing. Upon learning of the incident, the DH immediately deployed staff to the DPC to investigate and instructed the person-in-charge of the DPC to submit an investigation report within four weeks. The DPC was also required to implement a series of improvement measures, including immediately suspending the acceptance of new cases for reproductive technology procedures and making appropriate arrangements for individuals receiving relevant services at the DPC.
      
     On July 7, the Council on Human Reproductive Technology (Council) suspended 14 out of 17 licensed treatment services of the DPC, allowing only three services related to the storage of gametes or embryos to continue pending the completion of the investigation.
      
     The DH received the report submitted by the DPC on July 29, which covered immediate measures and long-term improvement plans. The DPC has also implemented several remedial measures regarding the handling and storage of embryos and embryo biopsy specimens.
 
     The DH has concluded that the DPC was non-compliant with the Code of Practice regarding timely reporting of Serious Untoward Events. Accordingly, the DH has issued regulatory requirements and reminded the DPC that it must report such events within 24 hours of identification. The DH also noted that the DPC had revised its procedures and reporting forms to ensure staff compliance with the requirements of the Code of Practice for reporting Serious Untoward Events going forward. The DH will continue to monitor the effectiveness of these measures.
      
     The DH also noted that the Council convened a special meeting yesterday (September 3) to review the investigation report of its Investigation Committee and discuss matters related to the licence issued under the Council. The Council has instructed the DPC to implement further remedial measures. Until the Council makes a decision on the licensing matter, the DPC may only continue to provide three storage services for gametes or embryos.
      
     Given that the incident may involve intentional unlawful conduct by an individual, a Police investigation is ongoing. The DH has reminded the DPC to strengthen security measures and will maintain close liaison with the Police and provide necessary professional support to safeguard public safety.
      
     The DH reiterates that all private healthcare facilities licensed to provide reproductive technology procedures must strictly comply with the relevant licensing conditions and the Codes of Practice stipulated by the DH and the Council.

Ends/Friday, September 4, 2026
Issued at HKT 18:30

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