SINGAPORE: The Ministry of Health (MOH) issued a notice to Cordlife on Nov 30 after several of its cord blood unit storage tanks had been exposed to temperatures above the acceptable limits of below -150 degrees Celsius. MOH has told Cordlife to stop processes for up to six months.
More recently, the Foundation for the Accreditation of Cellular Therapy (FACT), an international body, has also begun investigating Cordlife. FACT, which had accredited Cordlife in 2015, is suspending its accreditation indefinitely.
MOH told Cordlife to temporarily stop the collection, testing, processing and/or storage of new cord blood and human tissues or provide new types of tests to patients. The danger of exposing cord blood units to suboptimal storage temperatures is that the stem cells in the cord blood may be damaged. Cord blood may be used to treat certain diseases, such as cancer.
Cordlife said on Dec 5 (Tuesday) that it was informed by FACT of the investigations the body had initiated after MOH’s Nov 30- announcement. CNA quoted Cordlife as saying, “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.”
MOH said on Nov 30 that it had received a complaint on July 24, 2023, from a member of the public who had alleged that cord blood units at Cordlife had been exposed to temperatures above 0°C and other service quality issues. The Ministry then carried out unannounced audits on the company from Aug 15, and Nov 16 to 21 this year.
“Between the first audit in August 2023 and second audit in November 2023, MOH’s inspectors had contacted CGL on multiple occasions to request for and clarify their reports, documents, and request for further explanations where discrepancies were noted,” MOH said.
MOH has told Cordlife to remedy the lapses it found and strengthen its governance and processes. The Ministry called the company’s lapses “distressing to many of their clients” and has told the company to reach out to all its clients to address their concerns.
FACT, founded in 1996, establishes standards for medical and laboratory practice in cellular therapies. It was co-founded by the International Society for Cell and Gene Therapy (ISCT) and the American Society for Transplantation and Cellular Therapy (ASTCT) for voluntary inspection and accreditation in cellular therapy.
FACT is now asking Cordlife to hand in “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,” CNA reported.
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