Suspension of accreditation will 'not impact' cord blood storage operations: Cordlife
The indefinite suspension of Cordlife's FACT accreditation will remain in place at least until the ongoing investigations by MOH are completed and issues are resolved.
File photo of a Cordlife counter at Parkway East Hospital.
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SINGAPORE: The suspension of its cellular therapy accreditation will not impact the storage of cord blood units at Cordlife Singapore, the company said in a regulatory filing on Thursday (Dec 7).
On Tuesday, the Foundation for the Accreditation of Cellular Therapy (FACT) suspended Cordlife’s accreditation indefinitely after it was found that tanks storing cord blood units were found to have been exposed to suboptimal temperatures.
The suspension will remain in place at least until the ongoing investigations are completed and issues are resolved.
“This update will not impact the storage of cord blood units at Cordlife Singapore. Cordlife Singapore has maintained FACT accreditation for the past eight years,” the company said.
It added that it will invite the global body for a "thorough inspection" once investigations by the Ministry of Health (MOH) have ended.
On Nov 30, MOH said seven of the tanks used by Cordlife, which is listed on the Singapore Exchange, to store cord blood units were exposed to temperatures above the acceptable limit of -150 degrees Celsius.
As a result, about 2,200 cord blood units belonging to approximately 2,150 clients have been damaged. Another 17,000 clients could be affected, pending investigations.
MOH conducted unannounced audits on Cordlife after it received a complaint from a member of the public on Jul 24, 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 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.
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In its filing, Cordlife also said it has notified another global body, the Association for the Advancement of Blood & Biotherapies (AABB), regarding the investigations by MOH.
Following this, the association “promptly initiated an extensive post-notification protocol”.
Cordlife Singapore has been requested to provide relevant documentation, complete a root cause analysis and develop a comprehensive corrective action plan to address the issues brought forward by MOH.
“As part of the ongoing investigation, AABB is continuing to collect relevant information to inform (the) next steps regarding the accreditation status of the facility,” the association added.
“AABB shares concerns that clients of CGL (Cordlife Group Limited) and other AABB-accredited cord blood facilities may have as a result of this situation. AABB is actively investigating these issues and is committed to working with CGL to restore a robust quality system to help prevent future adverse events.”
Cordlife said the latest update by AABB will not impact the storage of cord blood units as well, adding that it is engaging with the association and providing them with details about the ongoing investigations.
In a statement, CGL group CEO Tan Poh Lan again apologised to all of its clients for “any distress” that the incident has caused.
“We are working hard to update them on their individual situations as quickly as we can, as well as address the questions and concerns they rightly have,” she said. “Our conversations with the Ministry of Health are continuing and we hope to be able to provide further updates on our progress soon.
“We will be working closely with FACT and AABB to share updates and information as the investigation with MOH progresses.”
Cordlife – which is licensed in Singapore as a cord blood and human tissue banking service, as well as a clinical laboratory service – has been given 14 days to make representations to MOH.
