SINGAPORE: Cord blood banking is a commercial service provided by the private sector, and the government is limited in how it can intervene despite Cordlife's mishandling of its storage tanks, Senior Minister of State for Health Janil Puthucheary said on Wednesday (May 8).
"Government cannot overstep the law," Dr Janil said in response to parliamentary questions about Cordlife.
The Ministry of Health (MOH) is not a party to the commercial contracts that parents sign with service providers, he noted.
"There are limits to which the government can intervene, especially when it comes to issues of compensation and refunds," he said.
"The role that we might play in government is to engage with Cordlife and ask them to facilitate some form of recompense to maintain their relationship with their customers," he added.
MOH announced last November that Cordlife, a private blood bank that is listed on the Singapore Exchange, was under investigation after seven of its tanks were exposed to temperatures above -150 degrees Celsius, the acceptable limit for cord blood units.
About 2,200 cord blood units belonging to approximately 2,150 clients were damaged.
Further investigations found that another 5,300 cord blood units were "non-viable". These units were stored in a tank and a dry shipper, which is intended for transport rather than long-term storage.
Last month, CNA reported that affected parents were unhappy with refunds offered, and that one client had sent a letter of demand to the company.
On Tuesday, Cordlife said a "significant number" of clients whose cord blood units were damaged have accepted refunds, but declined to reveal the exact figure.
13:47 Min
In Parliament on Wednesday (May 8), Senior Minister of State for Health Janil Puthucheary said that the Government understands the anxiety and concerns among parents as a result of the lapses at cord blood bank Cordlife. He said in his reply to MPs' questions that cord blood banking is an elective commercial service provided by the private sector and the Ministry of Health (MOH) is not a party to these contracts. Dr Janil also said that the Government "cannot overstep the law", and there are limits to which it can intervene, especially when it comes to issues of compensation and refunds. "What MOH is actively doing is with respect to regulation and facilitation," he said. This includes supervising the proper completion of further tests in the affected tanks to achieve a high level of confidence in the findings, a process which he said will take another year. He added that the ministry will also closely monitor Cordlife's dissemination of information to its customers and the public as well as the progress in addressing the deficiencies identified and in making improvements. He also said that MOH has discussed with other service providers that are prepared to facilitate the transfer of cord blood units. Dr Janil urged parents, however, to "carefully consider" the risks of doing so, given the logistical complexity of making a physical transfer at sub-zero temperatures, "particularly so, when the cord blood is not ascertained to be impacted".
Dr Janil said what MOH can do is related to regulation and facilitation.
"The ministry will be supervising the proper completion of further tests in the affected tanks, to achieve a high level of confidence in the findings," he said.
The testing will take another year to complete due to sample sizes and testing capacity.
Addressing a question on whether the testing can be sped up, Dr Janil said the timeline takes various operational factors into consideration, including rectification measures that Cordlife has been asked to put in place to reduce the chance of "warming events".
MOH will try to minimise the time taken, but maintain the quality of the findings, he said.
Retrieving and testing have to be done very carefully to avoid invalidating the potency of the sample when trying to establish the potency of the cord blood unit.
"For all of these reasons, and then subsequently the assessment and review of the results, it does appear that the one-year timeline is reasonable," said Dr Janil.
"We understand the need ... to expedite this and reassure people as fast as possible, but I think it's important that when the process is complete, that all who are involved have confidence in the findings from the process."
The ministry also said it will closely monitor the company's communication with its customers and the public, and its progress in addressing deficiencies and making improvements.
It will direct Cordlife to properly validate and implement its new temperature monitoring system, revalidate its processing method for cord blood units and improve staff training and supervision of operations.
Singapore Cord Blood Bank, Stemcord and Cryoviva are able and willing to help parents transfer their cord blood units from Cordlife if they wish to do so, though they each have specific conditions that must be met.
"They will only accept cord blood units that are demonstrated to be still viable, and the receiving cord blood banks are unlikely able to guarantee the viability of cord blood units that are then transferred from Cordlife.
"So there is some risk to the customer, the parents, associated with making the choice for this transfer, and it will also take some time. It's not a small decision to be taken lightly."
Dr Janil urged parents to "carefully consider" the risks, because of the logistical complexity of making a physical transfer at sub-zero temperatures, especially when the cord blood is not ascertained to be impacted.
Five tanks at Cordlife, containing about 14,000 cord blood units, have been assessed to be at low-risk of being affected.
Continue reading...
"Government cannot overstep the law," Dr Janil said in response to parliamentary questions about Cordlife.
The Ministry of Health (MOH) is not a party to the commercial contracts that parents sign with service providers, he noted.
"There are limits to which the government can intervene, especially when it comes to issues of compensation and refunds," he said.
"The role that we might play in government is to engage with Cordlife and ask them to facilitate some form of recompense to maintain their relationship with their customers," he added.
MOH announced last November that Cordlife, a private blood bank that is listed on the Singapore Exchange, was under investigation after seven of its tanks were exposed to temperatures above -150 degrees Celsius, the acceptable limit for cord blood units.
About 2,200 cord blood units belonging to approximately 2,150 clients were damaged.
Further investigations found that another 5,300 cord blood units were "non-viable". These units were stored in a tank and a dry shipper, which is intended for transport rather than long-term storage.
Last month, CNA reported that affected parents were unhappy with refunds offered, and that one client had sent a letter of demand to the company.
On Tuesday, Cordlife said a "significant number" of clients whose cord blood units were damaged have accepted refunds, but declined to reveal the exact figure.
13:47 Min
In Parliament on Wednesday (May 8), Senior Minister of State for Health Janil Puthucheary said that the Government understands the anxiety and concerns among parents as a result of the lapses at cord blood bank Cordlife. He said in his reply to MPs' questions that cord blood banking is an elective commercial service provided by the private sector and the Ministry of Health (MOH) is not a party to these contracts. Dr Janil also said that the Government "cannot overstep the law", and there are limits to which it can intervene, especially when it comes to issues of compensation and refunds. "What MOH is actively doing is with respect to regulation and facilitation," he said. This includes supervising the proper completion of further tests in the affected tanks to achieve a high level of confidence in the findings, a process which he said will take another year. He added that the ministry will also closely monitor Cordlife's dissemination of information to its customers and the public as well as the progress in addressing the deficiencies identified and in making improvements. He also said that MOH has discussed with other service providers that are prepared to facilitate the transfer of cord blood units. Dr Janil urged parents, however, to "carefully consider" the risks of doing so, given the logistical complexity of making a physical transfer at sub-zero temperatures, "particularly so, when the cord blood is not ascertained to be impacted".
TIMELINE FOR TESTING IS "REASONABLE"
Dr Janil said what MOH can do is related to regulation and facilitation.
"The ministry will be supervising the proper completion of further tests in the affected tanks, to achieve a high level of confidence in the findings," he said.
The testing will take another year to complete due to sample sizes and testing capacity.
Addressing a question on whether the testing can be sped up, Dr Janil said the timeline takes various operational factors into consideration, including rectification measures that Cordlife has been asked to put in place to reduce the chance of "warming events".
MOH will try to minimise the time taken, but maintain the quality of the findings, he said.
Retrieving and testing have to be done very carefully to avoid invalidating the potency of the sample when trying to establish the potency of the cord blood unit.
"For all of these reasons, and then subsequently the assessment and review of the results, it does appear that the one-year timeline is reasonable," said Dr Janil.
"We understand the need ... to expedite this and reassure people as fast as possible, but I think it's important that when the process is complete, that all who are involved have confidence in the findings from the process."
The ministry also said it will closely monitor the company's communication with its customers and the public, and its progress in addressing deficiencies and making improvements.
It will direct Cordlife to properly validate and implement its new temperature monitoring system, revalidate its processing method for cord blood units and improve staff training and supervision of operations.
Singapore Cord Blood Bank, Stemcord and Cryoviva are able and willing to help parents transfer their cord blood units from Cordlife if they wish to do so, though they each have specific conditions that must be met.
"They will only accept cord blood units that are demonstrated to be still viable, and the receiving cord blood banks are unlikely able to guarantee the viability of cord blood units that are then transferred from Cordlife.
"So there is some risk to the customer, the parents, associated with making the choice for this transfer, and it will also take some time. It's not a small decision to be taken lightly."
Dr Janil urged parents to "carefully consider" the risks, because of the logistical complexity of making a physical transfer at sub-zero temperatures, especially when the cord blood is not ascertained to be impacted.
Five tanks at Cordlife, containing about 14,000 cord blood units, have been assessed to be at low-risk of being affected.
Continue reading...