DH responds to media enquiries regarding "Heal Fertility Limited"
In response to media enquiries regarding "Heal Fertility Limited" (the centre), which was previously requested to stop accepting new cases for reproductive technology procedures following a Serious Untoward Event involving a mix-up in embryo biopsy specimens, the Department of Health (DH) announced today (October 5) that in light of the confirmation by the Council on Human Reproductive Technology (Council) that the centre has properly implemented all remedial and improvement measures, and has been approved by the Council to fully resume all 17 treatment services covered by its licence from tomorrow (October 6), the DH lifted its earlier directive suspending the centre from accepting new patients for assisted reproductive technology procedures. Starting tomorrow, the centre will be able to fully resume accepting new patients for assisted reproductive technology procedures.
Regarding the centre's failure to report the Serious Untoward Events to the DH within 24 hours of identification, as required by the Code of Practice for Day Procedure Centres (Code of Practice) under the Private Healthcare Facilities Ordinance (Cap. 633) (the Ordinance), the DH completed an investigation and issued a press release early last month stating that the centre had implemented a series of improvement measures as directed by the DH to prevent the recurrence of similar incidents and to ensure strict compliance in the future with the Code of Practice, which requires reporting any Serious Untoward Events to the DH within 24 hours of identification. If there is non-compliance to the Code of Practice by licensed private healthcare facilities, the DH will take regulatory action according to the risk level posed by the non-compliance to patient safety.
The DH once again reminded all private healthcare facilities holding licences from the Council to provide reproductive technology procedures that they must strictly comply with the relevant licensing conditions and the Codes of Practice stipulated by the DH and the Council. The DH will continue to monitor the compliance of licensed private healthcare facilities with the requirements of the Ordinance, the licensing conditions, and the Code of Practice, in order to safeguard public safety.
Source: AI-found images
Council on Human Reproductive Technology approves full resumption of services at "Heal Fertility Limited"
The following is issued on behalf of the Council on Human Reproductive Technology:
The Council on Human Reproductive Technology (Council) convened a special meeting today (October 5) to review the licence of "Heal Fertility Limited" (Heal Fertility). In view of the earlier incident involving a mix-up in embryo biopsy specimens at Heal Fertility, Council members thoroughly reviewed the information obtained from a follow-up on-site inspection, and confirmed that Heal Fertility has properly implemented all remedial and improvement measures. Therefore, the Council allowed Heal Fertility to fully resume all 17 treatment services covered by its licence starting tomorrow (October6).
Since July 8, the Council had suspended Heal Fertility's 14 treatment services out of 17, with the exception of three services related to the storage of gametes or embryos, and hadset up an investigation committee to investigate the matter. The Council had convened a special meeting on September 3 to review the investigation report and the licence matters of Heal Fertility.
This meeting followed up on a special meeting held by the Council on September 3 regarding the same incident. At that time, the Council accepted its conclusion that the main cause of the incident may involve intentional unlawful conduct by an individual, and considered that there is still room for further enhancement in Heal Fertility's overall performance and operational arrangements following the incident.Consequently, on September4, the Council sent a letter to Heal Fertility, explicitly requiring Heal Fertility to duly carry out a set of concrete improvement measures to prevent a recurrence of similar incidents. Until Heal Fertility had properly implemented the measures, it could only continue to provide three services related to the storage of gametes or embryos.
On September 22, the Council conducted another unannounced onsite inspection of Heal Fertility, focusing on all aspects of the remedial measures.
The Council was satisfied and convinced that Heal Fertility had refined its internal samplehandling procedures, strengthened staff training, and upgraded laboratory management and security systems in accordance with the Council's requirements, including the implementation of CCTV surveillance on the premises, the installation of biometric locks on all cryostorage tanks, and the enhancement of sample identification and verification. The Council also noted that the main personnel involved in the incident had already left Heal Fertility, and that Heal Fertility has recruited new staff and provided training. After thoroughly reviewing the relevant reports and inspection results, the Council therefore allowed Heal Fertility to resume normal operations starting tomorrow. The Council will continue to closely monitor Heal Fertility's performance to safeguard the continuous provision of safe and high-quality services to individuals seeking human reproductive technology services.
Moreover, the Council has commenced a review of the Code of Practice on Reproductive Technology and Embryo Research. Key areas include reviewing the incident reporting mechanism and optimising the security and handling procedures of biological samples, with a target completion date of next year.
Source: AI-found images
