Timeline: Cordlife's mishandling of cord blood units in Singapore
When did the breaches at Cordlife occur? When was the board informed and how did the issue come to light? CNA tracks the timeline of events.
SINGAPORE: Singapore-listed cord blood bank Cordlife has been in the spotlight for damaging thousands of cord blood units.
These cord blood units were stored in seven tanks that were exposed to temperatures above acceptable limits, the Ministry of Health (MOH) announced in November 2023.
It said then that about 2,200 cord blood units - belonging to about 2,150 clients - in one tank were damaged.
On Apr 8, 2024, it added that about 5,300 cord blood units stored in a second Cordlife tank and a dry shipper have been deemed "non-viable".
Parents have demanded answers from Singapore's longest-running private cord blood bank, with many saying they should have been informed earlier.
Here is a timeline of events.
February, March, June 2022: An estimated 2,200 cord blood units in one of the affected tanks were exposed to temperatures beyond acceptable limits for several days, according to Cordlife's inventory records provided to MOH.
September 2022: MOH conducted an inspection of Cordlife as part of a biennial routine. No lapses relating to the temperature of the storage tanks were found. Cordlife did not disclose any incidents during or after the routine inspection.
February 2023: Cordlife's board was informed by its management that one of its cord blood tanks had been exposed to irregular temperatures over several days in June 2022.
The board assessed the financial impact of the incident and deemed that there would be "no material impact" on the company's performance for the financial year that ended on Dec 31, 2022, and the one ending on Dec 31, 2023. Based on this, the board did not make an announcement.
Jul 24, 2023: A member of the public lodged a complaint with MOH, alleging that cord blood units stored in a Cordlife tank had been exposed to temperatures above 0 degrees Celsius in addition to other service quality issues.
Aug 15, 2023: MOH conducted a first unannounced audit on Cordlife. The ministry contacted Cordlife Group Limited to request reports and clarifications, documents, as well as further explanations where discrepancies were noted.
Nov 16 to Nov 21, 2023: MOH conducted a second round of unannounced audits on Cordlife. Audits showed that Cordlife's cryopreserved cord blood units had been exposed to temperatures above acceptable limits in seven of its 22 storage tanks at different periods, dating back to November 2020.
Nov 30, 2023: MOH announced its investigation into Cordlife. The ministry said that its three appointed experts had conducted an independent review of Cordlife's test results of one of its seven affected tanks.
All the experts concluded that the cord blood units stored in that tank were damaged and unlikely to be suitable for stem cell transplant purposes.
MOH ordered Cordlife to stop the collection, testing, processing and/or storage of any new cord blood and human tissues, or provide any new types of tests to patients, for a period of up to six months. The company was given 14 days to make representations on the suspension.
Cordlife said it was in the process of contacting clients to inform them of the status of their cord blood units or to outline ongoing testing. The company said it will continue to store affected clients' cord blood in the tank until their child turns 21. All future storage fees for the affected clients will be waived until then.
Dec 5, 2023: In a regulatory filing, Cordlife said that its cellular therapy accreditation has been indefinitely suspended by the Foundation for the Accreditation of Cellular Therapy, a global non-profit corporation which conducts inspections and accreditation in cellular therapy, pending the corporation's investigations into the issue.
Dec 6, 2023: The Association for the Advancement of Blood & Biotherapies, a non-profit association representing organisations and individuals involved in transfusion and cell transplantation medicine, told CNA that it was investigating the issue and is collecting information to determine the next steps for Cordlife's accreditation status with the association.
Dec 7, 2023: Cordlife said in a regulatory filing that the updates by both bodies will not impact its cord blood storage operations.
Dec 8, 2023: Health Minister Ong Ye Kung said investigations for the six other affected storage tanks at Cordlife should take another six weeks or so. He advised parents to hold off their transfer requests.
Dec 10, 2023: Cordlife said in a regulatory filing in response to queries from the Singapore Exchange Securities Trading that some members of its management had been aware that one of its cord blood tanks had been exposed to irregular temperatures over several days in June 2022 after being alerted by an employee. It added that the incident was reported to the board in February 2023.
Dec 13, 2023: Cordlife announced that it would accept the six-month suspension and will not be submitting written representations to MOH.
January 2024: The Health Ministry said it found more potential lapses at Cordlife. These include ineffective incident reporting frameworks, inadequate training and competence of staff, as well as the inappropriate storage of cord blood units, among others, said Cordlife in a regulatory filing on Jan 23.
Three days later, MOH said the final test results to determine the viability of mishandled cord blood units is estimated to be ready in end-March.
Mar 14, 2024: Cordlife called for a trading halt.
Mar 22, 2024: Cordlife announced that former Group CEO Tan Poh Lan and four board members have been arrested in relation to potential breaches of the company's disclosure obligations.
Mar 27, 2024: The company announced that Chief Financial Officer Thet Hnin Yi has also been arrested in connection with the investigations. She was released on bail.
Apr 5, 2024: Cordlife announced that a non-independent non-executive director on the board Yiu Ming Yiu has been arrested and released on bail in connection with the case. He is the seventh person to be arrested.
Apr 8, 2024: MOH announced that another 5,300 cord blood units in a second Cordlife tank and dry shipper were deemed to be "non-viable".
Eight out of 12 samples from the second tank, Tank B, failed the tests, as did five out of 12 samples from the dry shipper.
Cordlife said that for the high-risk tanks, it will offer a refund of annual fees "received from the start of the temperature excursion". It will also waive future storage fees for clients until their child turns 21 while continuing to store the cord blood.
The remaining five tanks have been assessed to be at low risk. They contain about 14,000 cord blood units.
"MOH’s experts have recommended that Cordlife test a larger number of cord blood units in these five tanks to obtain a more statistically significant result and further ascertain the status of the cord blood units stored in these tanks," the ministry added.
Apr 17, 2024: Cordlife's board of directors lodged a police report over “potential wrongdoings” of former employees amid an internal investigation into why the cord blood units in Tank A were damaged.
The board said in a bourse filing that the report was made without two directors – Mr Zhai Lingyun and Ms Chen Xiaoling.
May 19, 2024: The eighth arrest linked to the case was announced by Cordlife in a bourse filing.
The company said Ms Chen Xiaoling, a non-independent non-executive director on its board, was arrested and released on bail, after attending an interview at the office of the Singapore Police Force's Commercial Affairs Department (CAD) on May 15.
May 27, 2024: Cordlife was informed that its suspension, which was due to end on Jun 15, would be extended for up to another three months.
Authorities had determined that more time was needed to ensure the company could meet the requirements to resume its cord blood banking operations.
Jul 29, 2024: Cordlife announced the arrest of another director. According to a bourse filing, Mr Zhai Lingyun, a non-independent non-executive director on the company's board, was arrested on Jul 25 and released on bail.
Aug 26, 2024: Cordlife announced that its controlling shareholder Nanjing Xinjiekou Department Store has decided not to buy over the company's remaining shares as the offer could present risks that are "not aligned" with Nanjing Xinjiekou's investment criteria and business strategy.
Aug 29, 2024: MOH announced that Cordlife will be allowed to resume cord blood banking services with certain restrictions.
It may collect, test, process and store no more than 30 units of new cord blood per month, from Sep 15 to Jan 13, 2025.