Global body indefinitely suspends Cordlife's accreditation over mishandled cord blood
The Foundation for the Accreditation of Cellular Therapy (FACT) has also initiated investigations into the circumstances raised by MOH over Cordlife's storage tanks being exposed to suboptimal temperatures.
A Cordlife booth at an event. (File photo: Facebook/Cordlife Singapore)
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SINGAPORE: The Foundation for the Accreditation of Cellular Therapy (FACT) has indefinitely suspended the cellular therapy accreditation of private cord blood bank Cordlife, after tanks storing cord blood units were found to have been exposed to suboptimal temperatures.
Cordlife, which is listed on the Singapore Exchange, said in a regulatory filing on Tuesday (Dec 5) that it has received a notice from FACT, informing the company that the accreditation body has initiated internal investigations into the circumstances raised in the notice from the Ministry of Health (MOH) regarding the storage tanks. Cordlife has been accredited by FACT since November 2015.
“FACT has notified that effective immediately, the company’s FACT accreditation will be suspended indefinitely, at a minimum until FACT’s investigations are completed and issues are resolved,” said Cordlife.
On Nov 30, MOH said seven of the tanks used by Cordlife to store cord blood units were exposed to temperatures above the acceptable limit of -150 degrees Celsius.
MOH 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 ministry then conducted unannounced audits on the company on Aug 15, and Nov 16 to Nov 21.
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.
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.
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.
FACT ESTABLISHES STANDARDS FOR CELLULAR THERAPIES
FACT is a non-profit corporation co-founded in 1996 by the International Society for Cell and Gene Therapy (ISCT) and the American Society for Transplantation and Cellular Therapy (ASTCT) for the purposes of voluntary inspection and accreditation in the field of cellular therapy.
According to its website, FACT establishes standards for high-quality medical and laboratory practice in cellular therapies, and is the only international standard used in Europe, Canada, Australia, New Zealand and the US.
Aside from FACT, Cordlife is also accredited by the Association for the Advancement of Blood & Biotherapies (AABB), a non-profit association representing organisations and individuals involved in transfusion and cell transplantation medicine.
Cordlife added that FACT has requested the company to submit “certain reports relating to the ongoing investigations conducted by MOH, the results of a comprehensive root cause analysis of the issues and the company’s short and long-term corrective plans”.
FACT may also require additional information and inspection to document compliance with its standards, it added.
“The company will work closely with FACT to provide all necessary information that has been requested in order to restore its accreditation,” Cordlife said.
“The company will update its shareholders and the investing public, if there are any material developments, in accordance with the requirements of the SGX-ST listing rules.”
In response to CNA's queries, AABB said on Wednesday it has initiated an "extensive post-notification protocol".
Cordlife has been asked to prevent documentation as well as to "complete a root cause analysis and develop a comprehensive corrective action plan to address the issues brought forth by the MOH".
AABB added that it is continuing to collect relevant information to determine what are the next steps over Cordlife's accreditation status.
"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," said the global body.
It is "actively investigating" the issues and is working with Cordlife to restore its systems to prevent future incidents.
"We remain steadfast in our commitment to protecting the safety and availability of blood and biotherapies, understanding that conformance to AABB standards delivers optimal levels of quality and safety. "
