IVF MIX-UP INCIDENT

IVF MIX-UP INCIDENT: 9.

Dr Lam Pin Min asked the Minister for Health what is the outcome of the Ministry's investigation into the IVF mix-up incident and what will the Ministry do

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to reassure patients, both local and foreign, that similar incidents will not happen again in the future.

The Minister for Health (Mr Khaw Boon Wan): Sir, my Ministry has completed the investigation into the IVF mix-up incident at Thomson Medical Centre (TMC). The investigators have concluded that the mix-up was due to lapses in procedures and human error.

Assisted Reproduction Centres handle specimens from many couples. To eliminate the risk of any mix-up, they follow a number of procedures in accordance with international best practices. First, the embryologist will work on the specimens of only one individual or one couple at a workstation at a time. Second, he will carefully label all the receptacles and instruments with the couple’s or the individual’s name. Third, he will discard the disposable instruments such as pipettes after each use. This is to avoid any contamination. Fourth, at every critical step, a second operator will counter-check that the specimens are transferred to the correct receptacles.

The investigators found that the TMC IVF Centre had deviated from some of these procedures. At the time of the incident, the embryologist was processing semen specimens of two individuals at the same workstation at the same time. The pipette used for transferring the specimen was reused instead of being discarded after each step. Even though it was reused only for handling the specimens from the same individual, it unnecessarily raised the risk of human error. This was particularly risky as there was no second person to counter-check that the specimens were transferred to the correct receptacles at every critical stage. These lapses in procedure contributed to the occurrence of a human

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error and both led to the IVF mix-up in this case.

Following this incident, my Ministry has directed all Assisted Reproduction Centres to strictly follow the correct procedures, if they have not been doing so. My Ministry has also suspended the operation of the TMC IVF Centre.

The incident has impacted the reputation of the TMC IVF Centre and indirectly affected Singapore’s reputation as a regional medical hub. TMC has been responsive and has cooperated fully with my Ministry in the investigation. They are determined to recover from this incident. The key is full disclosure of the facts and immediate correction of any systemic inadequacies to ensure that similar errors will not recur. This is the way to regain patients' confidence and trust.

Dr Lam Pin Min (Ang Mo Kio): Thank you, Minister, for the reply. I would like to ask the Minister a few supplementary questions. Firstly, how many IVF Centres did the MOH find which did not follow the recommended SOPs and as a result, it could possibly have resulted in other mix-ups which were not detected? Secondly, what is the right of the patient whose specimen has been mistakenly used for this IVF incident and whether he should be informed of this mix-up? Lastly, with regard to the Straits Times ' report on the scarcity of sperm donors, what is the Ministry's position on this and is this is a cause for concern?

Mr Khaw Boon Wan: Sir, there are nine IVF Centres in Singapore. We call them Assisted Reproduction Centres. After the incident, we re-checked all the nine Assisted Reproduction Centres. Two of them, besides TMC, did not comply with all the procedures. That means that there were six who fully complied. All the public sector Assisted Reproduction (AR) Centres fully complied with the SOP.

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What is the right of the unintended parent or father in this case? We consulted the National Medical Ethics Committee. We tasked it to convene a meeting to discuss this particular incident because many parties are involved here and there are obligations and ethical duties of the operator and the hospital towards each of these parties, and all have to be taken into account. They have given very sound advice; they said that TMC will have a duty towards each and everyone of those parties involved. However, in fulfilling all those duties, it may conflict or cause other problems to some of the parties involved, and their advice is that the baby's rights should take priority. In the case of this unintended father of the baby, their advice is if the donor asked, then TMC will have a duty to inform. But TMC need not volunteer the information, taking into account the impact it may have especially on the baby. We have shared the National Medical Ethics Committee's advice with TMC.

As for the shortage of sperm donations, this is a global phenomenon. I think we are not alone in having a shortage of people coming forward to donate sperms.

Mr Sin Boon Ann (Tampines): Sir, given what has happened, I would like to ask the Minister whether the Ministry has done any audit to satisfy itself that what has happened is the only incident that has happened so far, and that nothing of this nature has happened before, save for one that is reported.

Mr Khaw Boon Wan: We carry out regular audits on all Assisted Reproduction Centres, including Thomson Medical Centre. But should we go backwards in time and start checking every IVF baby to see whether there has been a mix-up in the past? Short of doing a DNA parentage test on every IVF baby, we will never know.

I think we should do what is

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practical. Based on the information that we have, we are not aware of other mix-ups, certainly not in recent years.

Mr Speaker: Last question, Assoc. Prof. Straughan.

Assoc. Prof. Paulin Tay Straughan (Nominated Member): May I follow up on the Minister's response to the last supplementary question? Would the Ministry consider offering free DNA matches for successful IVF cases if the parents and the children so choose to validate the process?

Mr Khaw Boon Wan: Sir, we offer a DNA parentage testing service but whether we should offer it for free is a separate issue.