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).
The Council on Human Reproductive Technology, Photo source: reference image
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.
"Heal Fertility Limited," Photo source: reference image
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.
"Heal Fertility Limited," Photo source: official website of Heal Fertility
