Cordlife could face fresh one-year suspension over 'significant lapses'

MOH audit finds compliance gaps, process failures in handling of new cord blood units

- Yap Wei Qiang

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 in November 2023 after audit checks found 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 took to address critical shortcomings.

Cordlife’s licence was also renewed for one year from Jan 14, with a planned midpoint audit by MOH. Such licences are usually renewed for a period of two years.

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.