Cordlife could face a new one-year suspension over significant lapses
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Cordlife Group has 14 days to submit its written representations to the Health Ministry.
ST PHOTO: AZMI ATHNI
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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 has 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.
In response to media queries, Cordlife said it is currently reviewing the issues raised by MOH, and has not decided whether it will be making representations or accepting the suspension without making representations.
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 proper maintenance of the safety and quality of all existing CBUs.
Cord blood contains stem cells that can 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 midpoint audit of Cordlife in July.
Cordlife first received a six-month suspension allowed to resume operations in a calibrated manner
Cordlife’s licence was also renewed for one year
However, the midpoint 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 (staff) 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 that Cordlife had collected since January 2025.
Lapses included CBUs that were gradually frozen for storage and did not reach the optimal temperatures, 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 not being reported or investigated.
There were also cord blood collection 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 Cordlife to replace the CGO for improper discharge of duties, and to review all stored CBUs and lab records of the 160 CBUs newly collected in 2025 for any deviations from the SOPs.
Other directives 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 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 related to the seven CBU storage tanks that were exposed to warmer-than-required temperatures, which could damage the stem cells in the cord blood.
A total of 264 samples were tested. Out of approximately 14,000 CBUs stored in five of these tanks, samples from three tanks containing 12,000 units did not pass the tests.
Earlier tests on the first two tanks found about 7,500 CBUs unviable. The number of affected clients is unclear, as each client could store more than one CBU with Cordlife.
MOH has directed Cordlife to conduct a full investigation into 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 in Singapore, 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, Cryoviva and Stemcord.
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.
MOH will continue to closely supervise Cordlife’s rectification of the identified lapses. Should the firm continue to fail to meet regulatory requirements, even after the intended suspension period, its licence to operate might be revoked.
Cordlife to reach out to all impacted clients
Cordlife told The Straits Times that it will conduct a thorough internal review to address all non-compliance issues raised.
“We respect the decision of MOH and take these developments seriously... Where compliance gaps are confirmed, we will work closely and constructively with the relevant authorities to ensure each issue is fully rectified as we work towards reinstating our licence in Singapore,” said a spokeswoman.
Cordlife said it will keep all affected clients fully informed throughout the process.
It also pledged to continue to safeguard all existing CBUs during the suspension period, and protect their viability and integrity.
“Cordlife is committed to restoring confidence in its operations and rebuilding trust with all our stakeholders,” the spokeswoman said.
Correction note: In an earlier version of the story, we said that out of approximately 14,000 cord blood units (CBUs) tested from five of the storage tanks, samples from three tanks containing 12,000 units did not pass the tests. MOH has clarified that 264 samples were tested. Out of approximately 14,000 CBUs stored in five of these tanks, samples from three tanks containing 12,000 units did not pass the tests.
