Cordlife Faces Potential Suspension of Cord Blood Banking Services Following Audit
Cordlife Group, a private cord blood bank in Singapore, is facing a possible one-year suspension of its cord blood banking services. This comes after the Ministry of Health (MOH) issued a notice of intent following a recent audit that revealed significant operational lapses.
MOH's Concerns and Cordlife's Response
The MOH audit in July uncovered failures in several key areas, including governance, incident reporting, and the collection, processing, and testing of new cord blood units (CBUs). Cordlife has 14 days to submit written representations to the ministry before a final decision is made. In the meantime, Cordlife has stated that it is reviewing the issues raised.
If the suspension proceeds, Cordlife will be prohibited from banking new CBUs and will be required to focus on maintaining the safety and quality of its existing inventory of stored units. Cord blood contains stem cells that can be used to treat blood diseases and certain cancers.
Background and Previous Lapses
This regulatory action follows a previous six-month suspension imposed in November 2023 after audits revealed storage lapses. Cordlife was allowed to resume operations in a limited capacity in September 2024, after addressing critical shortcomings identified by the MOH. The company's license was renewed for one year in January 2025, with a planned midpoint audit by the MOH.
In November 2023, it was revealed that seven of Cordlife's storage tanks had been exposed to suboptimal temperatures, damaging approximately 2,200 CBUs. Subsequent testing by a third-party lab in April 2024 determined that around 5,300 CBUs in another tank were also unlikely to be suitable for stem cell transplant purposes. Approximately 14,000 CBUs from five of these tanks were tested, with results showing that the samples from tanks containing 12,000 units did not pass the required tests.
Specific Operational Failures Identified
The MOH audit revealed specific failures, including the storage of CBUs that had not reached the appropriate temperature for cryopreservation, with no evidence of investigations into potential damage. The Clinical Governance Officer (CGO) provided inappropriate advice to staff, leading to underreporting of incidents and process failures in the collection, testing, and processing of approximately 160 new CBUs collected since January 2025. Cord blood collection bags that had been exposed to temperatures outside the acceptable range were also used without validation.
MOH Directives and Client Communication
The MOH has directed Cordlife to replace its current CGO, review all lab records of new CBUs collected since January 2025, and identify and resolve any deviations from established policies. Cordlife is also required to inform affected clients and offer counselling by a haematologist on the implications for potential clinical uses of their CBUs. The MOH has urged Cordlife to proactively engage clients and address their concerns.
If the suspension proceeds, stored CBUs can only be released for clinical use after a qualified haematologist has assessed their suitability. The MOH will continue to supervise Cordlife's rectification efforts, and its operating license may be revoked if regulatory requirements are not met.
Alternative Options and Next Steps
The MOH has acknowledged that these findings may be distressing for Cordlife clients and has initiated discussions with other cord blood banks in Singapore, including the Singapore Cord Blood Bank, Cryoviva, and Stemcord, regarding their capacity to accommodate potential transfers. However, the ministry has advised that the transfer of CBUs carries risks and should be carefully considered. Alternative sources of stem cells, such as donated cord blood or bone marrow transplants, remain available.
Cordlife has stated that it will conduct a thorough internal review to address all non-compliance issues raised by the MOH and is committed to restoring confidence in its operations.