Cordlife Group faces one-year suspension over cord-blood banking service lapses

[SINGAPORE] Cordlife Group has been served a notice of intent for a one-year suspension of its cord-blood banking services by the Ministry of Health (MOH), after a recent audit uncovered significant failures in its operations. 

The notice, issued on Monday (Sep 29), requires the private cord-blood bank to stop collecting, testing, processing and storing new cord blood units and to focus solely on safeguarding its existing inventory.

Cordlife has 14 days to submit its representations.

The suspension was triggered by an MOH audit in July this year, which found that Cordlife had failed to maintain compliance with regulatory requirements in several key areas. This inspection came after the company had been allowed to resume limited operations in September 2024, following an earlier suspension.

This is the latest setback for the company, whose mishandling of cord-blood units first came to light in November 2023, when MOH conducted unannounced audits on the company.

Then, it was revealed that seven of the 22 tanks at Cordlife were exposed to temperatures above acceptable limits at different periods from November 2020. This damaged the cord-blood units belonging to at least 2,150 clients.

In December 2023, Cordlife was ordered to halt its services for six months. This restriction was extended by three months in June 2024, and the company was allowed to resume limited services on Sep 15, 2024.

Following the audit this July, and in line with the latest notice of intent, MOH has directed the company to review all laboratory records of new cord-blood units collected since the resumption of its cord-blood banking services in January 2025, and to identify and resolve any deviations from Cordlife’s established policies.

Cordlife must also inform clients if their cord-blood units have been affected, and offer counselling by a haematologist on the implications on potential clinical uses of the cord-blood unit.

In a statement, MOH said it “recognises that these findings may be distressing to many Cordlife clients, and they may now be contemplating withdrawal of their cord-blood units from Cordlife”.

The ministry has urged Cordlife to proactively engage with clients and address their concerns, including on issues relating to their contracts.

“Cordlife’s clients may wish to transfer cord-blood units to alternate providers,” MOH said, noting that it had “initiated discussions” with other cord-blood banks in Singapore on their plans if they are approached to receive such transfers.

MOH advised, however, that the transfer of cord-blood units – to both local and overseas banks – carries risks and should be considered carefully. “Alternative sources of stem cells, such as donated cord blood or transplant of bone marrow or peripheral blood stem cells, remain available for children who require transplants,” it added.

Operational lapses identified

The ministry’s midpoint audit found that Cordlife had sustained its improved temperature-monitoring practices and had kept an accurate inventory of its cord-blood units. However, the audit also revealed lapses in Cordlife’s governance, incident management, and processes for collecting and testing about 160 new cord-blood units since January 2025.

Specific failures found by the audit in July included:

• Improper storage: The company stored cord-blood units that had not reached the appropriate temperature for cryopreservation, with no evidence of proper investigation into potential damage.
• Poor oversight: Cordlife’s clinical governance officer wrongly advised staff that these issues were not of concern, which resulted in similar incidents not being reported and investigated, and no appropriate corrective or preventive actions implemented.
• Unvalidated equipment: Cordlife continued using cord-blood collection bags that had been exposed to temperature excursions without validating if they were still safe to use, or if the quality of the cord-blood unit would be affected.

These issues were compounded by the departure of key personnel who had overseen earlier improvements, with no proper handover process established.

A panel of experts reviewed the audit findings, and MOH decided to suspend Cordlife’s services for new cord-blood units to allow the company to address gaps in its key operational areas. The ministry has also directed the company to replace its current clinical governance officer.

If the suspension proceeds, Cordlife will be allowed to release stored cord-blood units for clinical use only after a suitably qualified haematologist has assessed that they are fit for the intended clinical use.

Failed samples from testing of low-risk tanks

Adding to the regulatory crisis, the expanded testing results for five tanks previously assessed as “low-risk” following temperature warming events in 2023 revealed significant issues.

The initial testing of 30 samples from these five tanks in 2023 had passed viability and potency tests, but MOH experts had required additional testing of over 200 samples to achieve a more statistically significant result.

Last Friday, MOH concluded that only samples from two tanks met the criteria for viability and potency.

The other three tanks failed. One had two failed samples out of 65, another had nine out of 65, and the last had three out of 64. The acceptance criteria allowed only one failed sample per tank.

Cordlife’s root-cause analysis has been unable to identify a conclusive reason for the failed samples. The ministry has directed the company to conduct a full investigation.