Singapore’s Health Minister warns of regulatory action amid Cordlife’s breach investigation

SINGAPORE: Health Minister Ong Ye Kung stated that the Ministry is actively investigating the underlying causes of the breaches involving Cordlife Group Limited (CGL). These breaches have led to the compromise of cord blood units under their custody.

In a Facebook post on Friday (8 Dec), Minister Ong affirmed that depending on the findings of our investigations, the authorities will follow up with the necessary regulatory and enforcement actions against Cordlife, given the severity of the breaches and the impact on clients.

“This is to ensure proper accountability, and to underscore the importance of industry players to adhere to the required regulatory standards. ”

Cordlife, a private cord blood bank listed on the Singapore Exchange, is currently under investigation following an incident where seven of its 22 cord blood units (CBU) storage tanks were exposed to temperatures exceeding acceptable limits.

In a press statement released last Thursday (30 Nov), the Ministry of Health (MOH) disclosed that during their investigation, the affected storage tanks were found to have been exposed to temperatures above the acceptable threshold of -150 degrees Celsius for cord blood units.

This exposure resulted in damage to approximately 2,200 cord blood units belonging to about 2,150 clients. Moreover, it potentially impacts an additional 17,000 clients, pending further investigation.

Subsequently, MOH ordered Cordlife to cease collecting, testing, processing, or storing new cord blood and human tissues for up to six months. Cordlife is required to make representations to MOH within 14 days.

Addressing concerns from the public about the lapse at Cordlife, Minister Ong acknowledged the understandable distress among many parents.

However, he highlighted that investigations are ongoing, including ascertaining the extent of temperature deviations in the other six affected tanks and evaluating the viability of stored cord blood units. This comprehensive assessment is estimated to take around six more weeks.

Besides ongoing investigations, MOH has initiated or will be undertaking additional steps in the upcoming weeks.

This includes discussions with other cord blood banks to potentially facilitate the transfer of cord blood units from Cordlife to alternative banks upon parental request.

“We advise that parents hold off these requests for now, until the full impact of the breaches are known in a few weeks.”

This cautious approach considers the possibility of unaffected units remaining and the potential for Cordlife to enhance its processes, potentially rendering physical transfers unnecessary.

“Beyond these immediate measures to protect the interest of the public and Cordlife’s clients, MOH will ensure that all relevant industry players learn from this episode.”

Minister Ong reassured affected parents that MOH would continue providing updates as new information becomes available.

Recent inspection exposed serious breaches

In the 30 Nov statement, MOH highlighted Cordlife’s previous successful inspections in 2022 without any reported temperature-related concerns.

However, following a public complaint in July, MOH conducted unscheduled audits on Cordlife in August 2023 and from November 16 to 21, 2023.

These audits revealed significant issues: seven out of 22 cord blood unit (CBU) storage tanks had experienced temperature excursions above acceptable limits from November 2020 to the present.

Experts appointed by MOH concluded that cord blood units stored in one affected tank were no longer viable for stem cell transplant purposes due to the damage incurred.

MOH uncovered various process lapses at Cordlife, including failures in the temperature monitoring system for two tanks from February to June 2022, missed six-monthly preventative maintenance for two tanks in 2022, and the improper validation of a new cord blood processing method implemented in August 2023.

Consequently, Cordlife was directed to rectify these issues and enhance its procedures under close monitoring by MOH. The company was also instructed to reach out to affected clients, providing updates on the status of their cord blood units.

in a bid to reassure parents, MOH conducted focused audits on three other licensed cord blood banks in Singapore from November 15 to 22, 2023, ensuring proper handling, storage, and distribution of cord blood units.

These audits revealed no concerning temperature excursions in Cryoviva (Singapore) Laboratory Services, Stemcord Private Limited, and the Singapore Cord Blood Bank.

Cordlife’s response

Addressing the affected cord blood units stored in the initial tank, Cordlife acknowledged that these units represented 2.66% of all stored units at their Singapore facility.

Despite the damage rendering them unsuitable for transplants, Cordlife expressed its intent to retain and store them, citing potential future relevance in advancements in cell and gene therapy.

Cordlife assured continued storage for these affected units until the child reaches 21 years old, waiving storage fees for the clients involved. Additionally, they committed to finding suitable replacement cord blood units if deemed necessary by healthcare providers.

This incident marked the first such occurrence in Cordlife’s 22-year history of cord blood storage in Singapore and the region, leading CEO Tan Poh Lan to express remorse for failing to meet their high standards.

FACT’s suspends Cordlife’s accreditation Indefinitely

On 6 Dec, the Foundation for the Accreditation of Cellular Therapy (FACT) took the significant measure of indefinitely suspending Cordlife’s accreditation.

Cordlife disclosed in a regulatory filing on Thursday that it had received notification from FACT. This notice informed Cordlife of FACT’s initiation of internal investigations into the circumstances raised by MOH regarding the storage tanks.

 Cordlife has been accredited by FACT since November 2015.

Cordlife additionally disclosed that FACT had requested the company to furnish specific reports about the ongoing investigations conducted by MOH, comprehensive root cause analysis findings, and the company’s strategies for short and long-term corrective actions.

FACT, established in 1996 through collaboration between the International Society for Cell and Gene Therapy (ISCT) and the American Society for Transplantation and Cellular Therapy (ASTCT), operates as a non-profit organization conducting voluntary inspections and providing accreditation in the cellular therapy field.

Apart from FACT accreditation, Cordlife also holds accreditation from the Association for the Advancement of Blood & Biotherapies (AABB), an organization representing professionals and entities involved in transfusion and cell transplantation medicine.

In a statement released on Tuesday, AABB announced the initiation of an extensive post-notification protocol in response to the situation.

This protocol entails various steps, including Cordlife’s provision of relevant documentation, conducting a comprehensive root cause analysis, and formulating an all-encompassing corrective action plan addressing the issues highlighted by MOH.

AABB is collecting pertinent information to determine the facility’s accreditation status as part of its ongoing investigation.

Cordlife assured that despite the suspension of its cellular therapy accreditation by FACT, there will be no impact on the storage of cord blood units.