SINGAPORE – Private cord blood bank Cordlife could face a fresh one-year suspension of its cord blood banking services after significant lapses were found during an audit by the Ministry of Health (MOH).

Cordlife Group Limited will have 14 days to submit its written representations to MOH, before the ministry decides whether to proceed with the suspension. If Cordlife does not submit any representations, the suspension will take effect from Oct 14 .

Once suspended, Cordlife will not be able to bank new cord blood units (CBUs). But it can continue operations and will be required to focus on the proper maintenance of the safety and quality of all existing CBUs.

Cord blood contains stem cells that may be used to treat blood diseases and some cancers, such as leukaemia and lymphoma, should the baby develop these illnesses later in life.

The regulatory action from MOH comes after “significant lapses” were discovered during its mid-point audit of Cordlife in July.

Cordlife was first slapped with

a six-month suspension

in November 2023 after audit checks found that there were lapses in its storage of CBUs. It was eventually allowed to resume operations in a calibrated manner from Sept 15, 2024, after MOH was satisfied with the steps it had taken to address critical shortcomings.

Cordlife’s licence was also

renewed for one year

from Jan 14 , with a planned mid-point audit by MOH. Such licences are usually renewed for a period of two years.

However, the mid-point audit found that Cordlife had failed to maintain its compliance with various regulatory requirements, including governance, incident reporting and management, as well as processes for collection, testing and processing of new CBUs.

At a media briefing on Sept 29 , an MOH spokesman said that previous improvements – such as establishing standard operating procedures (SOPs) for CBUs – were still in place.

“I think the problem is that there was quite a huge turnover,” said the spokesman. There did not appear to be a properly established handover process, which meant that newer staff were unable to demonstrate that they understood the SOPs and could adhere to them , according to the spokesman.

MOH also highlighted that one of the key leaders in Cordlife – an unnamed Clinical Governance Officer (CGO) – was found to have failed to provide proper oversight and guidance.

This led to process failures in the collection, processing and testing of about 160 new CBUs, which Cordlife collected since January 2025.

Lapses included CBUs that were gradually frozen for storage and did not reach the optimal temperature of minus 150 deg C, but continued to be stored.

There was also no evidence that proper investigations were conducted to determine if these deviations could have damaged the stem cells.

The CGO then gave inappropriate advice that these were not issues of concern, resulting in an unknown number of similar incidents being unreported, nor investigated.

There were also cord blood collections bags exposed to inappropriate temperatures being used without validating if these would affect the quality of the CBUs collected.

On Sept 29, MOH issued a Notice of Intent to Cordlife on the one-year suspension.

It also directed the Cordlife to replace the CGO for improper discharge of duties, and to review all stored CBUs, as well as the lab records of the 160 CBUs newly collected this year, for any deviations from the SOPs.

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Other directions from MOH require Cordlife to maintain its existing CBUs and facilitate their transfer or retrieval for clinical use, and to release CBUs only after a qualified external haematologist confirms their suitability for the intended clinical use.

The cord blood bank must also disclose any deviations to affected clients, have a qualified haematologist counsel affected clients on the implications, and to allow clients to make informed decisions on continued CBU storage.

In addition, Cordlife must retrain all laboratory personnel and implement an effective supervisory framework to ensure compliance with SOPs.

MOH also shared the latest test results for seven CBU storage tanks t hat were exposed to warmer-than-required temperatures above minus 150 deg C, which could damage the stem cells in the cord blood.

Out of approximately 14,000 CBUs tested, 12,000 units were deemed un suitable for future use.

This brings the total number of CBUs deemed no longer viable to about 19,500. The number of affected clients is unclear, as each of them could store more than one CBU with Cordlife.

MOH has directed Cordlife to conduct a full investigation on the testing results, as it could not identify conclusive reasons for the samples failing to meet the criteria for viability and potency.

MOH acknowledged that the latest findings may be distressing for Cordlife clients, some of whom may now be contemplating withdrawal of their CBUs from Cordlife.

The company has been urged to proactively engage its clients to address their concerns.

For affected clients who wish to transfer their CBUs to the other three cord blood banks, MOH has initiated discussion with the banks to understand their plans, as well as their capacity to accommodate the transfers.

The other cord blood banks are the Singapore Cord Blood Bank – the only public one in the Republic – as well as Cryoviva and Stemcord.

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MOH highlighted that the transfer of CBUs carries risks, and should be considered carefully.

It reiterated that should a privately-stored CBU be unsuitable for transplant, there are other options for cord blood transplants. These include tapping alternative sources of stem cells from donated cord blood, or transplant of bone marrow or peripheral blood stem cells.

The Straits Times has reached out to Cordlife for their response to MOH’s actions.