SINGAPORE: Singapore-listed cord blood bank Cordlife has been in the spotlight for damaging cord blood units belonging to at least 2,150 clients, with another 17,000 clients possibly affected.
These cord blood units were stored in seven tanks that were exposed to temperatures above acceptable limits.
This was made public in November 2023 when the Ministry of Health (MOH) announced that investigations against Cordlife were ongoing. MOH had received a complaint from a member of the public on Jul 24 about alleged issues with a storage tank.
It has since emerged that Cordlife's board knew of the issue in February.
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.
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These cord blood units were stored in seven tanks that were exposed to temperatures above acceptable limits.
This was made public in November 2023 when the Ministry of Health (MOH) announced that investigations against Cordlife were ongoing. MOH had received a complaint from a member of the public on Jul 24 about alleged issues with a storage tank.
It has since emerged that Cordlife's board knew of the issue in February.
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.
Related:
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.
Related:
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.
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