HONG KONG: Hong Kong will review whether there’s scope to strengthen the reporting mechanism for reproductive technology incidents after a local fertility clinic delayed its disclosure of embryo sample mix-ups, which prompted regulatory action.
Secretary for Health Lo Chung-mau made the response on Wednesday (July 8) following a disclosure by the Council on Human Reproductive Technology, which oversees in vitro fertilisation, that a locally based clinic, HEAL Fertility, had mishandled embryo biopsy specimens from two patients.
According to the council, the incident came to light after a laboratory of the Chinese University of Hong Kong at Prince of Wales Hospital in Sha Tin found that the embryo biopsy specimens of two women submitted by the clinic had failed to match the genetic profiles of either patient during routine verification.
In the first case, laboratory tests had shown that six of seven embryo biopsy samples did not match the intended parents. The second case involved two samples, both of which were found to be unrelated to the parents concerned.
Although HEAL Fertility was aware of both incidents on May 26 and June 4, a preliminary investigation by officials revealed that the clinic had never informed the Department of Health.
The clinic concerned did not report the matter to the CHRT until June 17 – a time lapse that has turned the spotlight not only on the clinic’s conduct, but also on the adequacy of the official disclosure discipline and reporting timeline for such incidents.
Lo said he agreed that the incident’s notification lag was “not very ideal”.
The Department of Health’s Office for Regulation of Private Healthcare Facilities, after having received the council’s referral on July 3, said the incident, which involves the erroneous identification of patient biopsy samples, meets the definition of a “serious untoward event” that must be reported to the authorities within 24 hours as per the Code of Practice for Day Medical Centres.
HEAL Fertility’s delayed notification, the office said, constitutes a contravention, adding that a regulatory notice had been issued requiring the clinic to submit an investigation report within four weeks to explain what caused the incidents and what remedial action it would take.
Lo noted that the CHRT had carried out several rounds of investigation after the clinic’s June 17 notification.
The Department of Health has moved promptly to follow up on the matter and handed the case to the police on Monday. A police spokesman said no arrests have been made so far.
Lo pledged that the authorities would await separate reports from the police, the CHRT and the clinic itself before deciding what procedural improvements are needed.
HEAL Fertility apologised to the clients involved on Tuesday night, saying it has formed an internal taskforce to review its procedures and make improvements wherever necessary.
The clinic said patients who’re worried about the identity of its specimens could ask for genetic testing for verification purposes.
Fourteen of the clinic’s 17 services have been suspended so far, with only three storage-related offerings still in place. - China Daily/ANN
