https://www.channelnewsasia.com/singapore/cordlife-cord-blood-units-bank-storage-tanks-investigation-moh-3956191

INVESTIGATIONS

MOH said during the company’s last inspection in September 2022, as part of a biennial routine for such services, it had not found any lapses relating to the temperature of the storage tanks based on random checks. Cordlife also did not disclose any incidents during or after the routine inspection.

But MOH received a complaint from a member of the public on Jul 24 this year, alleging that cord blood units stored in a tank at Cordlife had been exposed to temperatures above 0 degrees Celsius, in addition to other service quality issues.

The ministry then conducted unannounced audits on the company on Aug 15, and Nov 16 to Nov 21.

“Between the first audit in August 2023 and second audit in November 2023, MOH’s inspectors had contacted CGL (Cordlife Group Limited) on multiple occasions to request for and clarify their reports, documents, and request for further explanations where discrepancies were noted,” it said.

The audits showed that Cordlife’s cryopreserved cord blood units had been exposed to temperatures above acceptable limits in seven of its 22 storage tanks at different periods, dating back to November 2020.

MORE THAN 19,000 CLIENTS COULD BE AFFECTED

“Based on CGL’s inventory records provided to MOH, an estimated 2,200 cord blood units belonging to approximately 2,150 clients in one of the affected tanks (Tank A) were exposed to temperatures beyond the acceptable limits for several days in February, March and June 2022,” said the Health Ministry.

“CGL had tested some of the donated cord blood units stored in Tank A to establish the cell viability of the affected cord blood units. MOH appointed a panel of three cord blood banking experts to conduct an independent review of CGL’s test results,” it said.

“All of the experts have concluded that the cord blood units stored in Tank A have been damaged, and are unlikely to be suitable for stem cell transplant purposes.”

MOH also found that Cordlife’s temperature monitoring system failed to send notifications of the temperature excursions in two tanks to Cordlife personnel between February and June 2022.

It added that the company’s six-monthly preventative maintenance was also not carried out for two tanks in 2022, while a new cord blood processing method implemented in August 2023 was not properly validated according to approved plan and protocol.

Personal Comments: Sorry to see that so many clients being affected. Stem cells from cord blood are highly precious and have a great utility in a multitude of treatments.