Cordlife probe finds temperature in one tank went as high as 20.4 deg C in 2021

ONE storage tank at cord-blood banker Cordlife Group was found to have hit a temperature as high as 20.4 degrees Celsius in 2021, according to a report obtained by The Business Times. This was way over both international standards, as well as the company’s internal acceptable temperature range.

Cordlife is scrutinising lab reports and work communications of key personnel in its laboratory, as it attempts to determine why critical incidents or “temperature excursions” involving several cord blood units (CBU) storage tanks were not immediately reported and escalated.

Among management’s discoveries – cord blood samples were moved without proper records and documentation, and a “significant number of samples” may have been moved to a dry shipper that recorded instances of irregular temperatures in 2019.

Dry shippers are not meant for permanent storage, but are designed for the safe shipment of specimens.

Senior members of management were only made aware that there were samples in the dry shipper in November last year, according to the report, which was prepared by Cordlife in response to private queries from market regulator Singapore Exchange Regulation (SGX RegCo).

Among other things, SGX RegCo has asked the company for a chronology of events relating to irregular temperatures in Cordlife’s storage tanks from November 2020 – when the earliest incident was said to have taken place.

Singapore’s Ministry of Health (MOH) announced in November that it had issued a notice to Cordlife to stop – for a period of up to six months – the collection, testing, processing and/or storage of any new cord blood and human tissues. The company also cannot provide any new types of tests to patients.

Above acceptable limits

MOH’s move followed two audits done last year after “a member of the public” complained to the regulator, alleging that CBUs stored in a tank at Cordlife had been exposed to suboptimal temperatures as well as other “service quality issues”.

The audits found seven of Cordlife’s 22 CBU storage tanks were exposed to temperatures above the acceptable limits of below minus 150 deg C, MOH said in a Nov 30 statement. Investigations are ongoing.

Cord blood is blood from the placenta and umbilical cord. Cord-blood transplants have been used to cure serious diseases, and many parents bank their children’s cord blood as a form of insurance.

Based on international standards, the biological and functional properties of the CBUs are preserved when storage temperatures are at below minus 150 deg C; any warmer and the CBUs will start to thaw, risking damage to the stem cells in the cord blood. Cordlife’s internal standard is even lower, at minus 165 deg C.

Cordlife’s report to SGX RegCo, however, noted more than 10 episodes between November 2020 and July 2022 when certain tanks had out-of-range temperature fluctuations, based on tank controller temperature data.

In most instances, Cordlife alleged that the relevant staff had not escalated these fluctuations to senior management.

These temperature excursions, except for one that occurred in June 2022, were only brought to management’s attention by MOH during the regulator’s audit last year, said Cordlife.

The company’s daily manual monitoring procedures carried out by lab staff had not raised any red flags.

In response to a question on who was aware of these incidents and whether any remedial actions were taken, Cordlife disclosed that some individuals in its laboratory operations involving the relevant tanks at the time are no longer with the company.

Failure to alert

Its management is still trying to rule out any wrongdoing.

As for the June 2022 incident, inspection records indicate the company’s monitoring system, Laboratory Environment Monitoring Alarm System, failed to send a text message alert to designated lab staff when the tank failed to keep within the programmed parameters.

Certain members of Cordlife’s management team were notified of this matter in June, following which the incident was reported to the board in February 2023, Cordlife said previously in a public response to SGX queries.

The company also said the board made no announcements at the time as it took the view that there would be no material impact on the financial performance of the group for FY2022 and FY2023.

These events may be a setback for Cordlife, which boasts the largest network of stem-cell banking facilities in six key markets: Singapore, Hong Kong, Indonesia, India, Malaysia and the Philippines. This was more so at a time when awareness of stem-cell therapy and regenerative medicine are continuing to gain traction.

For the six months to June 2023, the company earned S$2.2 million in net profit, up 18 per cent from a year earlier, on the back of an 8 per cent improvement in revenue to S$28 million.

Singapore has three other licensed cord-blood banking service providers: Cryoviva (Singapore) Laboratory Services, StemCord and the Singapore Cord Blood Bank.

Since news of MOH’s audit findings and notice of compliance, Cordlife shares have lost about a third of their value – falling from S$0.45 to S$0.31.

Its group chief executive Tan Poh Lan apologised to clients, and added that this is the first such incident in the group’s 23-year history. Tan, who was formerly CEO of Parkway East Hospital and Gleneagles Hospital in Singapore, is set to leave the group at the end of March.

In October last year, the company announced she would be retiring to pursue her personal interests.