SINGAPORE - Licensed cord blood bank Cordlife Group Limited (CGL) has been found to have exposed cryopreserved cord blood units at suboptimal temperatures, damaging the cord blood units belonging to at least 2,150 clients and rendering them unsuitable for stem cell transplant purposes, said the Ministry of Health (MOH) on Nov 30.

The company has been ordered to stop collecting, testing, processing and/or storing any new cord blood and human tissues for a period of up to six months. It is also not allowed to provide any new types of tests to patients.

CGL has been given 14 days to make representations to MOH.

Investigations are ongoing and MOH will consider further enforcement actions, including imposing financial penalties or prosecution.

Cord blood unit (CBU) storage is a private service that has emerged over the last 20 years.

It is offered to parents when their babies are born. The cord blood contains stem cells known as hematopoietic stem cells, which may be used in stem cell transplants to treat blood diseases and some cancers, such as leukaemia and lymphoma, should the baby develop these illnesses later in life.

Cord blood may be donated to a public cord blood bank and made available to anyone who needs it.

The ministry said it had received a complaint on July 24, 2023, from a member of the public alleging that CBUs stored in a tank at CGL had been exposed to temperatures above 0 deg C, as well as other service quality issues.

When exposed to temperatures above the acceptable limits of below minus 150 deg C, the CBUs will start to thaw and the stem cells in the cord blood may be damaged.

Following the complaint, MOH conducted unannounced audits on the company on Aug 15 and from Nov 16 to 21. Between the first audit in August and the second in November, MOH’s inspectors contacted CGL on multiple occasions to request and clarify their reports and documents, and request further explanations where discrepancies were noted.

The audits uncovered that cryopreserved CBUs in seven of 22 CBU storage tanks had been exposed to temperatures above the acceptable limits at different periods from November 2020 to date.

One of the tanks, Tank A, had an estimated 2,200 CBUs belonging to approximately 2,150 clients, according to the company’s inventory records provided to MOH. The CBUs in Tank A were exposed to temperatures beyond the acceptable limits for several days in February, March and June 2022.

CGL had tested some of the donated CBUs stored in Tank A to establish the cell viability of the affected CBUs. MOH appointed a panel of three cord blood banking experts to conduct an independent review of CGL’s test results.

All the experts have concluded that the CBUs stored in Tank A have been damaged and are unlikely to be suitable for stem cell transplant purposes, said MOH.

Investigations are ongoing for the remaining six storage tanks containing approximately 17,300 CBUs that belong to an estimated 17,050 clients. Pending the investigation outcome, MOH will be consulting its experts to determine if similar tests should be performed on the CBUs stored in these six tanks.

CGL group chief executive officer Tan Poh Lan said this was the only time such incidents had happened in the company’s 22 years of storing cord blood in Singapore and across the region.

“We recognise that we have fallen short of the high standards that we hold ourselves to, and we sincerely apologise to our clients and will work diligently to regain their trust,” said Ms Tan in a media statement.

She added that the company will continue to store the damaged cord blood units for clients until their child turns 21, as they still may be valuable in the light of developments in the field of cell and gene therapy. All future storage fees for these clients will also be waived.

“We are in the process of contacting all of Cordlife Singapore’s clients to inform them of the status of their cord blood units or to outline the ongoing testing. As a further measure of quality control, Cordlife Singapore will voluntarily initiate testing of donated cord blood samples stored in all other unaffected tanks,” said Ms Tan.

In addition, she noted that under CGL’s standard service agreement with all clients, if their healthcare provider subsequently determines that the cord blood cannot be successfully used for an approved cord blood transplant, “Cordlife will make every effort to find a suitable replacement cord blood for their child”.

In addition to the temperature issues in the tanks, MOH also found that the company’s temperature monitoring system failed to send notifications to personnel when temperatures in two tanks deviated between February and June 2022.

The six-monthly preventative maintenance was also not carried out for two tanks in 2022. Additionally, the company implemented a new cord blood processing method in August 2023, which was not properly validated according to the approved plan and protocol.

“CGL has not taken adequate steps to expeditiously escalate, address and rectify the above issues, including the systemic problems which may have led or contributed to them,” said MOH.

The ministry added that it has directed CGL to take appropriate remedial actions to address the lapses and strengthen its governance and processes. MOH will closely monitor and audit the company.

“CGL’s lapses will be distressing to many of their clients. MOH has instructed CGL to reach out to all its clients to address their concerns. Individuals who are concerned should contact CGL directly to inquire about the status of their CBU and if their CBU is in the impacted lot,” said MOH.

CGL was last inspected in September 2022 as part of a biennial routine inspection for these services and MOH had not found any lapses relating to the temperature of the tanks based on random checks of its storage tanks. CGL also did not disclose any incidents during or after the routine inspection then.

Since CGL started its services in 2001, seven CBUs have been retrieved for treatment purposes. Similar usage incidence is observed in the other private cord blood banks in Singapore, said MOH.

To provide assurance to parents who have stored their CBUs in the three other licensed cord blood banks in Singapore, MOH conducted a targeted audit of these banks from Nov 15 to 22, 2023, focusing on the quarantine, storage and distribution of CBUs.

Investigations found there were no temperature deviations of concern at the other three licensed cord blood banking service providers, namely Cryoviva (Singapore) Laboratory Services, Stemcord and the Singapore Cord Blood Bank.