On Nov 30, the Ministry of Health (MOH) said Cordlife was under investigation after seven of its tanks storing cord blood units were exposed to temperatures above acceptable limits.
MOH conducted unannounced audits on the company on Aug 15, and Nov 16 to Nov 21, after receiving a complaint from a member of the public on Jul 24.
It was alleged 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 affected storage tanks were found to have been exposed to temperatures above -150 degrees Celsius, which is the acceptable limit for cord blood units.
Around 2,200 cord blood units – stored in one of the seven affected tanks – belonging to approximately 2,150 clients have been damaged. Another 17,000 clients could be affected, pending investigations into the other six tanks.
Cordlife said on Sunday the irregular temperature exposure in the affected tank, and one other tank in February and March 2022 was brought to the company’s attention during MOH’s unannounced audit in August.
NO NOTIFICATION AT THAT TIME
The private cord blood bank added it did not reveal it was the subject of an unannounced audit by MOH in August as there was no notification at that time that the company was deemed to be “in breach of any rules, regulation or law”.
On the process lapses that MOH noted in its Nov 30 report, Cordlife said its laboratory processes are subject to biennial audits by MOH, the Association for the Advancement of Blood & Biotherapies (AABB), and the Foundation for the Accreditation of Cellular Therapy (FACT).
As such, it had previously assessed that it would be a “more appropriate use of resources” for the internal audit to be focused on other areas of the company’s business”.
Cordlife also said that its FACT accreditation, which is indefinitely suspended, will not result in any material impact on its financial performance for FY2023 and its ability to continue business operations, as the accreditation is not a prerequisite to carry on its current business.
The company said on Dec 7 that the suspenion of its accreditation will not impact the storage of cord blood units at Cordlife Singapore.
On Dec 8, Health Minister Ong Ye Kung said in a Facebook post that investigations to determine the extent of temperature excursions for Cordlife’s six other affected storage tanks and the viability of the stored cord blood in them “should take another six weeks or so”.