The Ministry of Health (MOH) has suspended Cordlife Group from collecting, testing, processing, or storing new cord blood as of 26 November 2024. This decisive action comes in response to ongoing concerns about the company’s ability to maintain safe and clinically appropriate services.
Reasons for Suspension
MOH’s suspension follows a mid-point audit carried out in July 2024, which revealed that Cordlife had not adequately addressed previous concerns regarding its operational practices. Key issues included:
- Insufficient governance and oversight of services.
- Failure to comply with incident reporting and management protocols.
- Problems with the collection, testing, and processing procedures for new cord blood units.
Limited Operations Allowed
While Cordlife cannot collect new cord blood units, it can maintain existing ones and perform specific limited actions:
- Facilitating the transfer of existing cord blood units (CBUs) to other banks.
- Disposing of units according to client instructions.
Future Compliance Needed
According to MOH, the suspension will remain in place until Cordlife demonstrates consistent compliance with regulatory requirements for cord blood banking services. Key directives include:
- Replacing its current Clinical Governance Officer.
- Reviewing all laboratory records of the approximately 160 CBUs collected since January 2024.
MOH has indicated it will closely monitor Cordlife’s attempts to rectify these lapses and will not hesitate to impose further regulatory action if non-compliance continues.