2024年5月8日，新加坡卫生部高级政务部长普立杰医生代表卫生部长回复宏茂桥集选区议员娜蒂雅女士关于康盛脐带血样本检测时间的质询。

以下内容为新加坡眼根据国会英文资料翻译整理：

脐带血储存事件中受影响客户的支持和商业脐带血库责任审查（2）议长先生：有请娜蒂雅女士。

娜蒂雅女士（宏茂桥集选区议员）：议长先生，我感谢高级政务部长。我知道卫生部在这方面拥有更多的监督和管理权。高级政务部长强调了一年的检测期限，可以理解的是，由于等待时间过长，父母们会更加焦虑不安。卫生部如何评估用一年时间完成剩余检测的合理性？卫生部是否有其他方法可以为其他行业合作伙伴提供指导或支持，以加快脐带血单位的检测？

普立杰医生：议长先生，感谢娜蒂雅女士的提问。关于预估的样本检测时间，已经有一些评论。一些国际专家提供的意见是基于常规检测和已在实验室的样本的典型周转时间。我想有些人提到一次药效测试和返回结果需要两到三周的时间。

但这一系列评论并没有考虑到其他相关因素和本案的全部背景。将完成测试的时间评估为一年，这涉及到几个操作方面的考虑：康盛人生集团拥有的资源、受聘进行检测的第三方实验室的可用资源、康盛人生集团奉命采取的旨在减少进一步变暖事件的整改措施、实验室和康盛人生集团拥有的有限资源，以及卫生部在评估这些程序方面需要做的工作，即在我们控制下的解释部分，我们将尽量缩短所需的时间，加快进程，但要保持调查结果的质量。

我们需要程序稳健，以便在验证结果时，对验证结果有高度的信心。也许，我可以解释一下为什么需要这么长时间。

所谓的解冻后研究有几个阶段。这些阶段必须精心设计，取样必须非常小心，检测必须非常仔细，第三方（即验证和审核人员）也必须确信样本是以适当的方式处理的。

脐带血不是单独储存在一个储血罐中。脐带血储存箱中有许许多多的脐带血。它们在不同的条件下被提取和储存。因此，采样时需要考虑到冷冻时的处理方法。取样的方式必须非常非常小心，因为在确定样本有效性的过程中，你不希望使样本的有效性失效。因此，必须确保脐带血样本不会因疏忽而受损。

检测实验室需要具备立即接收样本的能力。因此，你不能将整个脐带血运送到实验室，然后让他们自己花时间处理所有样本。每个样本都必须有指定的接收和处理时间段，这样才能避免实验室方面的风险。而实验室的检测能力是有限的。能够进行检测的实验室非常有限。此外，也没有办法将样品分装后送往不同的实验室。样本只有这么多。因此，必须以非常特殊的方式处理这一小部分样本。因此，基于所有这些原因，再加上随后对结果的评估和审查，一年的时限似乎确实是合理的。

我们理解，从父母的担忧出发，有必要加快这一进程，以尽快让人们放心，但我认为，重要的是，当这一进程完成时，所有参与其中的人都要对这一进程的结果有信心。因此，我希望各位议员和父母谅解，我们需要一些时间来完成这个过程。

以下是英文质询内容：

SUPPORT FOR AFFECTED CUSTOMERS IN CORD BLOOD STORAGE INCIDENT AND REVIEW OF OBLIGATIONS OF COMMERCIAL CORD BLOOD BANKS（2）

Mr Speaker: Ms Nadia Samdin.

Ms Nadia Ahmad Samdin (Ang Mo Kio): Mr Speaker, I thank the Senior Minister of State. I understand that MOH has more supervisory and regulatory authority in this case. The Senior Minister of State highlighted about the one-year duration which, understandably, is causing parents even further anxiety, given the long wait. What is the Ministry’s assessment on the reasonableness of this one-year duration for completing the remaining testing? Is there any other way that MOH can provide direction or support for other industry partners to expedite the testing of the cord blood units?

Dr Janil Puthucheary: Sir, I thank Ms Nadia for the question. There has been some commentary about the length of time that is projected. The comments provided by some international experts are based on the typical turnaround time for routine testing and samples that are already in a laboratory. I think some people have quoted two to three weeks for a single potency test and returning the results.

But that series of comments does not take into account the other related factors and the full context of this case. The estimation of one year for the timeline for completing the testing involves several operational considerations. The resources that Cordlife has, the resources that are available at the third-party laboratory that has been engaged to perform the testing and the rectification measures that Cordlife has been instructed to put in place to mitigate further warming events, the limited resources that the laboratory and Cordlife have, as well as what MOH needs to do in terms of assessing these processes, those parts of the explanation that are under our control, we will try to minimise the time taken, expedite the process, but maintain the quality of our findings.

We need the process to be robust so that when the findings are validated, there is a high level of confidence in that validation. Perhaps, I might just explain why it takes so long.

There are several stages for what is called the post-thaw study. These have to be designed carefully, the samples have to be retrieved very carefully, the testing has to be done very carefully and the third parties, the people who are validating and auditing this, also need to be satisfied that the samples are being dealt with in the proper manner.

A cord blood unit is not stored in an individual tank. The storage units contain many, many cord blood units. They were retrieved and stored under different conditions. 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 do not 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 is no inadvertent compromise to the cord blood unit.

And the testing laboratory needs to then have the capacity to immediately receive the sample. So, you cannot ship the whole unit and then 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 that they are not then subject to risks at the laboratory side. And there is a limited capacity available for the testing. The laboratories that can do this are quite limited. There is also no way to divide up a sample volume and send it out to different laboratories. There is only so much of the sample that is there. So, that small amount has to be dealt with in a very particular way. So, 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.

We understand the need, from the parents’ concerns, to expedite this to reassure people as fast as possible, but I think it is important that when the process is complete, that all who are involved have confidence in the findings from the process. So, I would ask for Members and parents’ understanding that it will take some time for us to go through this process.

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