THERE are “limits” to how much the government can intervene in the issue of compensation and refunds requested by customers of embattled cord-blood bank Cordlife Group : P8A 0%, said Senior Minister of State for Health Janil Puthucheary in Parliament on Wednesday (May 8).
This is because cord-blood banking is an “elective, commercial service provided by the private sector” and customers have entered into contracts with such providers, to which the Health Ministry (MOH) is not a party, he added.
He was answering questions from Members of Parliament (MPs) on Cordlife’s temperature lapses, which caused some 7,500 cord-blood units stored in two tanks and a dry-shipper to be damaged or deemed at “high risk of being adversely affected”.
Seven out of 22 tanks had been exposed to temperatures above acceptable limits at different periods since November 2020. The lapses were uncovered by MOH, which suspended the cord-blood bank from collecting or processing new cord blood for six months.
Two Workers’ Party MPs were among those asking about refunds and compensation. Sengkang GRC MP Louis Chua asked if MOH could ensure that affected Cordlife customers receive a baseline level of compensation.
Hougang MP Dennis Tan asked if the ministry would consider strengthening the obligations of commercial providers, and require a full refund of fees if stored cord blood is found to be unusable.
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In response, Janil said MOH understands the “anxiety and concerns amongst parents” due to the lapses, but there are limits to intervention as MOH is not a party to these commercial contracts.
“Government cannot overstep the law,” he said.
However, the ministry is actively supervising Cordlife to ensure the proper completion of further tests in the affected tanks, to achieve a high level of confidence in the findings.
Cordlife previously said it will send for testing more than 200 samples – which it termed a “statistically meaningful number ” – of cord-blood units from the five tanks which were found to be low risk, to provide more assurance in the testing results.
MOH said in a statement then the larger sample must reach a 99 per cent confidence level, which means that 99 per cent of the samples tested must pass both potency and viability tests.
“Given the sample sizes and testing capacity available, this will take another year,” Janil noted on Wednesday.
He added that the estimated timeline of one year was reasonable due to the full context of the case, which involves operational considerations, Cordlife’s resources and the rectifications it has been ordered to make to mitigate further temperature incidents, as well as resources that are available at the third-party laboratories receiving the sample.
For example, under operational considerations, he highlighted that each tank contains several cord-blood units that were retrieved and stored under different conditions. Retrieving the samples for testing, therefore, requires considering the processing methods at the time of freezing.
“You don’t want in the course of establishing the potency of the unit to then invalidate the potency of that sample. So you have to make sure that there’s no inadvertent compromise to the cord-blood unit,” he said.
MOH will try to expedite the parts of the process that are under its control, he said.
The ministry will also closely monitor Cordlife’s dissemination of information to customers and the public, as well as progress in addressing the deficiencies identified and in making improvements.
These include directing Cordlife to properly validate and implement its new temperature monitoring system, revalidate its processing method for cord-blood units, and enhance staff training and supervision of its operations.
Cordlife on Tuesday said it started hiring more specialists to lead its laboratory teams as part of a major strategic overhaul.
Cord-blood transfer conditions
Janil reiterated that MOH discussed the issue with other cord-blood banking providers, who are prepared to facilitate the transfer of Cordlife customers’ cord-blood units, should customers opt to do so.
Besides Cordlife, there are two other private cord-blood banks in Singapore: Cryoviva (Singapore) Laboratory Services and StemCord. There is also one public bank, the Singapore Cord Blood Bank.
Parents who wish to transfer their cord-blood units can contact Cordlife and the receiving cord-blood bank to discuss the transfer arrangements, he said.
However, Janil urged parents “to carefully consider the risks of doing so”.
This is given the logistical complexity of making a physical transfer at sub-zero temperatures, particularly when the cord blood is not ascertained to be affected, he said.
The other three cord-blood banks also indicated that there are specific conditions that have to be met before it can receive the cord-blood units from Cordlife customers.
“All three cord-blood banks have processes in place to facilitate the transfer of the cord-blood units, but they will only accept cord-blood units that are demonstrated to be still viable,” he said.
He added that the receiving cord-blood banks are “unlikely to be able to guarantee the viability of cord-blood units” that are transferred from Cordlife.
“There is some risk to the customers associated with making the choice for the transfer, and it will take some time,” Janil said.
Shares of mainboard-listed Cordlife were flat at S$0.12 as at 12.57 pm on Wednesday.
