Hong Kong IVF clinic cleared to resume all services after embryo specimen mix-up

A Hong Kong fertility clinic that had most of its services suspended for mishandling embryo biopsy specimens from two patients has been cleared to fully resume all treatments after implementing improvement measures.

The Council on Human Reproductive Technology said on Monday that Heal Fertility in Central could resume all 17 treatment services covered by its licence from Tuesday, after members reviewed the findings of a follow-up inspection and confirmed the clinic had properly implemented the required corrective measures.

The clinic had been barred from providing 14 of its 17 licensed treatment services since July 8 following the embryo biopsy specimen mix-up involving two couples. It had only been allowed to continue three services related to the storage of gametes and embryos while investigations were under way.

The controversy emerged after Heal Fertility and the Chinese University of Hong Kong’s pre-implantation genetic testing centre notified the council on June 17 that embryo biopsy specimens sent for genetic testing were suspected of having been replaced by other specimens.

According to the council, tests later established that there had been no mix-up of the embryos stored at the clinic and there was no evidence that any embryos had been wrongly implanted.

In July, the council said initial findings suggested the incident might have been caused by human factors and launched an investigation.

In August, police classified the case as suspected fraud after investigators concluded that a former Malaysian embryologist might have made mistakes while handling embryo biopsy specimens and subsequently provided false information in an attempt to conceal them.

The woman left Hong Kong for Malaysia shortly after being interviewed by police and resigned from the clinic. Police later placed her on a wanted list.

01:17

Hong Kong IVF regulator orders partial suspension of HEAL Fertility clinic

The regulator said it held a special meeting on September 3 and accepted the investigation committee’s conclusion that “the main cause of the incident may involve intentional unlawful conduct by an individual”.

It nonetheless found room for improvement in the clinic’s operations and ordered it to carry out a series of enhancement measures before services could resume.

A surprise inspection was conducted on September 22 to assess implementation of the measures.

According to the council, Heal Fertility refined its sample-handling procedures, strengthened staff training and upgraded laboratory management and security systems.

Improvements included installing CCTV surveillance, fitting biometric locks on cryostorage tanks and enhancing sample identification and verification procedures.

The council also noted that the principal personnel involved in the incident had left the clinic and that new staff had been recruited and trained.

“The council was satisfied and convinced that Heal Fertility had refined its internal sample-handling procedures, strengthened staff training, and upgraded laboratory management and security systems in accordance with the council’s requirements,” it said.

The regulator added it would continue to closely monitor the clinic’s performance to ensure the provision of safe and quality reproductive technology services.

It has also begun reviewing the Code of Practice on Reproductive Technology and Embryo Research, including incident-reporting arrangements and biological sample security procedures, with the exercise expected to be completed next year.

Heal Fertility welcomed the regulator’s decision and said it would resume IVF and other reproductive services from Tuesday. The clinic said it would contact existing clients to explain the latest arrangements and schedule treatment according to their wishes.