On 30 November 2023, the Ministry of Health (MOH) has issued a notice to Cordlife Group Limited (CGL) to stop, for a period up to six months, the collection, testing, processing and/or storage any new cord blood and human tissues, or provide any new types of tests to patients, pending CGL’s written representations.
2. MOH has found that seven of CGL’s 22 cord blood units (CBU) storage tanks have been exposed to temperatures above the acceptable limits of below -150
oC
1. When exposed to suboptimal storage temperatures, the CBUs will start to thaw and the stem cells in the cord blood may be damaged. While investigations are still ongoing, a notice to stop is necessary to safeguard patients’ interest.
Background of Cord Blood Banking
3. CBU storage is a private service that has emerged over the last 20 years. It is offered to parents when their babies were first 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 leukemia 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. So far, the utilisation of privately banked cord blood has been low. 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.
4. Cord blood is not the only source of hematopoietic stem cells. Where hematopoietic stem cells are needed and a suitable CBU cannot be found, the transplant physician may also consider bone marrow or peripheral blood stem cells from matched siblings or human leukocyte antigen (HLA)-matched unrelated donors, and suitable donors listed in bone marrow registries as alternatives depending on the condition being treated.
Ongoing Investigations of Cordlife Group Limited5. CGL is currently licensed under the Healthcare Services Act 2020 (HCSA) as a cord blood banking service, human tissue banking service and clinical laboratory service. When CGL was last inspected in September 2022 as part of a biennial routine inspection for these services, MOH had not found any lapses relating to the temperature of the tanks based on random checks of their storage tanks. CGL also did not disclose any incidents during or after the routine inspection.
6. MOH subsequently received a complaint on 24 July 2023 by a member of the public alleging that CBUs stored in a tank at CGL had been exposed to temperatures above 0°C, as well as other service quality issues. Following the complaint, MOH conducted unannounced audits on CGL on 15 August 2023, and 16 to 21 November 2023. Between the first audit in August 2023 and second audit in November 2023, MOH’s inspectors had contacted CGL on multiple occasions to request for and clarify their reports, documents, and request for further explanations where discrepancies were noted.
7. The audits uncovered that CGL’s cryopreserved CBUs had been exposed to temperatures above the acceptable limits in seven of 22 CBU storage tanks at different periods from November 2020 to date. Based on CGL’s inventory records provided to MOH, an estimated 2,200 CBUs belonging to approximately 2,150 clients in one of the affected tanks (Tank A) were exposed to temperatures beyond the acceptable limits for several days in February, March and June 2022.
8. 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 of 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.
9. Investigations are ongoing for the remaining six storage tanks containing approximately 17,300 CBUs which belong to an estimated 17,050 clients. Pending the investigation outcome, MOH will be consulting our experts to determine if similar tests should be performed for the CBUs stored in these six tanks.
10. In addition to the temperature excursions in the tanks, MOH found the following process lapses at CGL:
i. CGL’s temperature monitoring system failed to send notifications of the temperature excursions in two tanks to CGL’s personnel between February and June 2022;
ii. CGL’s six-monthly preventative maintenance was not carried out for two tanks in 2022; and
iii. CGL implemented a new cord blood processing method in August 2023, which was not properly validated according to approved plan and protocol.
11. 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.
Actions Taken by MOH on CGL12. In view of the lapses found at CGL and to mitigate any adverse impact on new clients, MOH has issued notice to CGL on 30 November 2023 to stop CGL from collecting, testing, processing and/or storing any new cord blood, human tissues, or provide any new types of tests to patients for a period of up to six months. In accordance with HCSA, CGL has been given 14 days to make representations to MOH.
13. Investigations are ongoing and MOH will consider further enforcement actions, including imposing financial penalties or prosecution.
14. In the meantime, MOH has directed CGL to take appropriate remedial actions to address the lapses and strengthen their governance and processes. MOH will closely monitor and audit them.
15. 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 enquire about the status of their CBU and if their CBU is in the impacted lot.
No Irregularity of Temperature Excursions in Other Licensed Cord Blood Banks16. To provide assurance to parents who have stored their CBUs in the three other licensed cord blood banks in Singapore, MOH has conducted a targeted audit of these banks from 15 to 22 November 2023, focusing on the quarantine, storage, and distribution of CBUs.
17. Our investigations have found no temperature excursions of concern at the other three licensed cord blood banking service, namely Cryoviva (Singapore) Laboratory Services, Stemcord Private Limited and the Singapore Cord Blood Bank.
MINISTRY OF HEALTH
30 NOVEMBER 2023
1 Based on NetCord-FACT International Standards for Cord Blood Collection, Banking and Release for Administration, Seventh Edition. Under the US Pharmacopeia, General Chapter 1044, Cryopreservation of Cells, clinical specimens should not be warmer than -150oC, the glass transition temperature.