MOH may suspend Cordlife's cord blood banking services for a year following audit

The Ministry of Health (MOH) submitted its intention on Monday (Sept 29) to suspend operations of cord blood banking services at Cordlife for a year.

Cordlife has 14 days to submit its written representations to the ministry. Cordlife told the Straits Times that it is currently reviewing MOH's findings, and has not decided if it will submit representations or accept the suspension.

MOH said that a follow up audit on Cordlife conducted in July had found significant lapses in the collection and processing of new cord blood units (CBU).

Cord blood is the blood remaining in the umbilical cord and placenta after childbirth and contains blood stem cells, which have been successfully used in stem cell transplants to treat blood cancers, immune and genetic diseases.

The suspension will require Cordlife to focus on properly maintaining the safety and quality of its existing CBUs. It will be disallowed from banking new CBUs.

This intended action by MOH comes a year after the cord blood banking facility partially resumed operations in September 2024.

It was revealed in November 2023 that seven of Cordlife's 22 storage tanks had been exposed to suboptimal temperatures, damaging around 2,200 CBUs in one affected Tank A.

The six other affected tanks (B, C, D, E, F and G) and a dry shipper were subsequently tested by a third-party lab, which determined in April 2024 that about 5,300 CBUs in Tank B and the dry shipper are also unlikely to be suitable for stem cell transplant purposes.

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Tanks C, D, E, F and G were assessed to be at low risk of being adversely affected, though MOH experts recommended a larger number of CBUs in these five tanks to be tested to obtain a more statistically significant result.

MOH stated then that Cordlife estimates needing a year for conclusive tests of the five tanks to be completed.

The facility was allowed to resume cord blood banking services after audits in August and November 2024 showed it had satisfactorily addressed critical shortcomings.

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Its licence was then renewed for one year from Jan 14, 2025, with a planned mid-point audit by MOH in July to ensure that it continued to comply with regulatory requirements.

Since the full resumption of its cord blood banking services in January, approximately 160 new CBUs have been collected.

CBUs not cooled to appropriate temperature 

On Monday, the health ministry said the July audit found that Cordlife had sustained its improved temperature monitoring practices and kept an accurate inventory of CBUs.

But it had failed to comply with regulations in other operational areas including governance, incident reporting and management, as well as processes involving collection, testing and processing of new CBUs collected since January 2025.

The key personnel who contributed to the improvements in 2024 had resigned without a proper handover process in place and the Clinical Governance Officer (CGO) did not provide proper oversight and guidance, leading to the under-reporting of incidents and process failures across the collection, testing and processing of the new CBUs.

MOH said Cordlife had stored CBUs which were not cooled to the appropriate temperature for cryopreservation, and there was no evidence that investigation into whether this would have caused damage had been conducted.

Staff were inappropriately advised by the CGO that these were not of concern, which resulted in future similar incidents going unreported, and no appropriate corrective or preventive actions being implemented.

Cord blood collection bags exposed to temperature outside the acceptable range had also been used, without validation if the bags should still be used and if this could affect the quality of the CBU.

Clients of affected CBUs must be offered counselling

If the suspension proceeds, the company is only allowed to maintain existing stored CBUs and facilitate retrievals for transplant or to another cord blood bank.

The stored CBUs can only be released for clinical use after a suitably qualified haematologist has assessed that it is fit for the intended use.

The health ministry added that it has also directed Cordlife to replace its current CGO, review all lab records of the new CBUs collected since January, and identify and resolve any deviations from Cordlife's established policies.

It must also inform clients if their CBUs have been affected and offer counselling by a haematologist on the implications on potential clinical uses of the CBU.

MOH urged Cordlife to proactively engage clients and address their concerns.

The ministry added that it will continue to closely supervise Cordlife's rectification of the identified lapses and if it does not meet the regulatory requirements, its operating licence may be revoked.

Cordlife also told the Straits Times that it will conduct a thorough internal review to address all issues raised, and that it will keep all affected clients fully informed throughout the process.

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lim.kewei@asiaone.com