2024年5月8日，新加坡衛生部高級政務部長普立傑醫生代表衛生部長回復宏茂橋集選區議員娜蒂雅女士關於康盛臍帶血樣本檢測時間的質詢。
以下內容為新加坡眼根據國會英文資料翻譯整理：
臍帶血儲存事件中受影響客戶的支持和商業臍帶血庫責任審查（2）議長先生：有請娜蒂雅女士。
娜蒂雅女士（宏茂橋集選區議員）：議長先生，我感謝高級政務部長。我知道衛生部在這方面擁有更多的監督和管理權。高級政務部長強調了一年的檢測期限，可以理解的是，由於等待時間過長，父母們會更加焦慮不安。衛生部如何評估用一年時間完成剩餘檢測的合理性？衛生部是否有其他方法可以為其他行業合作夥伴提供指導或支持，以加快臍帶血單位的檢測？
普立傑醫生：議長先生，感謝娜蒂雅女士的提問。關於預估的樣本檢測時間，已經有一些評論。一些國際專家提供的意見是基於常規檢測和已在實驗室的樣本的典型周轉時間。我想有些人提到一次藥效測試和返回結果需要兩到三周的時間。
但這一系列評論並沒有考慮到其他相關因素和本案的全部背景。將完成測試的時間評估為一年，這涉及到幾個操作方面的考慮：康盛人生集團擁有的資源、受聘進行檢測的第三方實驗室的可用資源、康盛人生集團奉命採取的旨在減少進一步變暖事件的整改措施、實驗室和康盛人生集團擁有的有限資源，以及衛生部在評估這些程序方面需要做的工作，即在我們控制下的解釋部分，我們將儘量縮短所需的時間，加快進程，但要保持調查結果的質量。
我們需要程序穩健，以便在驗證結果時，對驗證結果有高度的信心。也許，我可以解釋一下為什麼需要這麼長時間。
所謂的解凍後研究有幾個階段。這些階段必須精心設計，取樣必須非常小心，檢測必須非常仔細，第三方（即驗證和審核人員）也必須確信樣本是以適當的方式處理的。
臍帶血不是單獨儲存在一個儲血罐中。臍帶血儲存箱中有許許多多的臍帶血。它們在不同的條件下被提取和儲存。因此，採樣時需要考慮到冷凍時的處理方法。取樣的方式必須非常非常小心，因為在確定樣本有效性的過程中，你不希望使樣本的有效性失效。因此，必須確保臍帶血樣本不會因疏忽而受損。
檢測實驗室需要具備立即接收樣本的能力。因此，你不能將整個臍帶血運送到實驗室，然後讓他們自己花時間處理所有樣本。每個樣本都必須有指定的接收和處理時間段，這樣才能避免實驗室方面的風險。而實驗室的檢測能力是有限的。能夠進行檢測的實驗室非常有限。此外，也沒有辦法將樣品分裝後送往不同的實驗室。樣本只有這麼多。因此，必須以非常特殊的方式處理這一小部分樣本。因此，基於所有這些原因，再加上隨後對結果的評估和審查，一年的時限似乎確實是合理的。
我們理解，從父母的擔憂出發，有必要加快這一進程，以儘快讓人們放心，但我認為，重要的是，當這一進程完成時，所有參與其中的人都要對這一進程的結果有信心。因此，我希望各位議員和父母諒解，我們需要一些時間來完成這個過程。
以下是英文質詢內容：
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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