SINGAPORE – Cordlife clients waiting to learn the viability of their cord blood units from six cryogenic tanks that had temperature lapses will have to wait till around the end of March, due to capacity constraints at the testing lab and for supplementary tests to be carried out.
Health Minister Ong Ye Kung had announced on Dec 8, 2023, that investigations into the extent of temperature lapses and viability of cord blood units would take roughly six weeks.
In its update on Jan 26, the Ministry of Health (MOH) gave assurances that it is working closely with Cordlife to ensure that the company progressively updates its clients as finalised results become available.
Processes at the cord blood banking company have come under the spotlight after the health authorities revealed on Nov 30, 2023, that cryopreserved cord blood units in seven of its 22 storage tanks were exposed to suboptimal storage temperatures.
Around 2,200 cord blood units in one of the affected tanks were damaged and rendered unsuitable for stem cell transplants.
Cord blood samples from the remaining six affected tanks and a dry shipper have been sent to a third-party laboratory to test the viability and potency of the cord blood units.
This covers 17,300 units belonging to an estimated 17,050 clients in the six affected tanks, and an estimated 2,400 units stored in the dry shipper.
Dry shippers are cryogenic containers used to transfer units from cord blood banks to medical facilities when the blood is released for treatment purposes. They are not meant for long-term storage.
Cord blood units have to be stored at temperatures below minus 150 deg C, or they could thaw and be damaged.
MOH audits had uncovered that units in the seven storage tanks had been exposed to temperatures above the acceptable limit at different periods from November 2020 to November 2023.
Preliminary investigations show that two of the six affected tanks, which stored about 2,300 cord blood units, were unlikely to be adversely affected by the temperature lapses. Results of the other tanks and the dry shipper are not ready.
“We estimate the final results will be ready in end-March 2024, due to capacity constraints of the laboratory and the need to conduct further tests using additional samples from different parts of the tank to ensure thoroughness of the findings,” said MOH.
The ministry added that the results will be sent to an independent expert panel for further verification, and the results of each tank will be progressively finalised.
“This process is to ensure that the outcomes of the study are conclusive and reliable, upon which clients can then make decisions,” it said.
MOH said it will await the testing results and the expert panel review to ascertain the impact of the temperature excursion on the affected tanks and dry shipper. Should the results for some of the samples be inconclusive, repeat testing and further consultation with the panel of experts will be required.
“We understand that many parents are eager to know the outcome of the investigation and we seek their patience,” the ministry said. “The transfer of cord blood units to another cord blood bank carries risks and should be an option that is considered carefully, accompanied by detailed discussions with the receiving cord blood bank.
“Parents are advised to wait until the completion of the testing and review of the results.”
MOH added that it will guide parents on the transfer policy and processes where appropriate.
It also said it had sent a letter to Cordlife on Jan 22, giving it till May 31 to rectify a list of potential non-compliances. Lapses include issues like ineffective incident reporting frameworks, inadequate training and competence of staff, and inappropriate storage of cord blood units.
On Jan 10, Senior Minister of State for Health Janil Puthucheary said that MOH will review regulatory requirements for cord blood banking following the Cordlife incident.
