MOH intervention limited in Cordlife customer refunds: Janil

Compensation and refunds for damaged cord blood units are governed by commercial contracts that the Ministry of Health (MOH) is not party to and, thus, the Government cannot intervene in such matters, said Dr Janil Puthucheary in Parliament on May 8.

Setting public expectations of the Government’s role following the discovery of mishandling by embattled cord blood bank Cordlife, the Senior Minister of State for Health said: “The Government cannot overstep the law. There are limits to which the Government can intervene, especially when it comes to issues of compensation and refund.”

He added that while MOH understands the anxiety and concerns of parents, cord blood banking is an elective, commercial service provided by the private sector.

Dr Janil was responding to Mr Louis Chua (Sengkang GRC), who asked if MOH could ensure that affected Cordlife customers receive a baseline level of compensation.

Processes at the company have been in the spotlight after it was revealed on Nov 30, 2023, that cryopreserved cord blood units in seven of its 22 storage tanks were exposed to sub-optimal storage temperatures. Cord blood units have to be stored at temperatures of no higher than minus 150 deg C.

About 7,500 cord blood units in two tanks and in a dry shipper – a container used to transport cord blood units at extremely low temperatures – have been deemed non-viable and unlikely to be suitable for stem cell transplants.

Mr Saktiandi Supaat (Bishan-Toa Payoh GRC) also asked how MOH would intervene following international experts’ criticism of Cordlife’s one-year timeline for testing the viability and potency of 200 samples in five cord blood tanks considered to be at low risk of being damaged.

The Straits Times reported on April 13 that such tests could be completed in six to 10 weeks, citing global experts.

Replying, Dr Janil said the comments from the experts are based on a typical turnaround time for routine testing of samples that are already in a laboratory, and do not take into account other operational considerations.

These include the limited resources that Cordlife and the third-party testing lab have, the rectification measures that Cordlife has been instructed to put in place to mitigate further warming events, and the work MOH needs to do in assessing these processes.

MOH will try to minimise the time taken and expedite the process, but the process needs to be robust so that there is a high level of confidence in the findings, said Dr Janil.

Giving details on why the process takes so long, Dr Janil said there are several stages in a post-thaw study. The experts who are validating and auditing the tests also need to be satisfied that the samples are dealt with in a proper manner, he said.

“(Cord blood units) were retrieved and stored under different conditions, and so the sampling needs to take into account the processing methods at the time of freezing. The way in which the retrieval is done has to be very, very careful because you don’t want to – in the course of establishing the potency of the unit – invalidate the potency of that sample,” said Dr Janil.

He also pointed out that the third-party lab needs to have the capacity to immediately retrieve the sample.

“You can’t ship the whole unit and let them take their own time to process all the samples. Each sample has to have a specified time slot for receipt and processing, so... they are not subject to risks at the laboratory site,” said Dr Janil, who added that labs have limited capacity, and there is no way to divide up a sample volume and send it to different laboratories.

“For all these reasons, and then subsequently the assessment and review of the results, it does appear that the one-year timeline is reasonable,” he added.

Dr Janil said parents who wish to transfer their cord blood units can contact Cordlife and the receiving cord blood bank to discuss the transfer arrangements.

However, he urged parents to carefully consider the risks of doing so, given the logistical complexity of making a physical transfer at sub-zero temperatures, particularly when the cord blood is not ascertained to be impacted.

There are currently three other cord blood banks in Singapore – private operators StemCord and Cryoviva Singapore, and public bank Singapore Cord Blood Bank.

MOH had discussed the issue of transfers with the providers, who are willing to facilitate the process.

However, all three operators have indicated that they will accept only cord blood units that are demonstrated to be still viable, and the receiving cord blood banks are unlikely to be able to guarantee the viability of cord blood units transferred from Cordlife, said Dr Janil.

“Each of the cord blood banks has indicated that specific conditions must be met prior to accepting the cord blood units from Cordlife. So there are some variants, and the customers will have to work directly with the receiving cord blood bank to operationalise the transfer. MOH will try to facilitate the connections and processes where it is within our power to do so,” he said.

MOH will also closely monitor Cordlife’s dissemination of information to its customers and the public, as well as progress in addressing the deficiencies identified and making improvements, said Dr Janil.

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.

Source: Straits Times © SPH Media Limited. Permission required for reproduction.

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