Fertility centres get revised dos and don’ts

Comprehensive labelling and counter-checking among lab practices spelt out by MOH

Exactly a year ago, a baby – conceived via assisted reproduction at Thomson Fertility Centre – made headlines when it was found not to have the father’s DNA.

Centres that provide such services have now been issued updated guidelines from the Ministry of Health (MOH) to boost standards in clinical practices and workflow processes, among other things.

The revision was carried out in April, and some changes came into effect in July and last month.

Key additions to the licensing terms and conditions for assisted reproduction services include a five-page list of proper laboratory practices. 

It spells out the need for clear labelling on every specimen and all test-tubes, pipettes and other apparatus in contact with any of the specimens. 

Counter-checking of the identification of specimens and the patients or donors at all critical points of the clinical and laboratory procedures must also be in place, with documentation of the checks done at the time they take place.

On clinical practices, a man giving his sperm has to personally submit it to the centre. He has to sign a written declaration and state the time and date of his attendance.

Centres are allowed to transfer at most two embryos into a patient’s body at any one time. Previously, patients who fulfilled certain conditions could get a maximum of four.

Women above 45 – who were previously not accepted for assisted reproduction treatments – may now qualify if an authorised doctor submits an appeal to the authorities. 

An MOH spokesman said the licensing terms are periodically revised to ensure that they remain relevant.

Assisted reproduction is carried out in at least 10 centres here, in both private and public hospitals. In 2009, 3,271 women used such treatments, resulting in 1,158 successful births.

A cycle of in-vitro fertilisation (IVF) treatment costs between $8,000 and $11,000 at public hospitals, and up to $15,000 at private centres.

Subsidies of up to $3,000 per cycle are available for patients in public hospitals.

Doctors are positive about the updated guidelines.

Dr Paul Tseng, medical director of the Centre for Assisted Reproduction at Paragon Medical, said the revisions were not major as certain practices, such as labelling, would already be in place.

“The ministry is simply spelling it out clearly now.”

Dr Yong Tze Tein, a senior consultant at the Singapore General Hospital’s (SGH’s) department of obstetrics and gynaecology, agreed. 

She said: “The updated guidelines are more defined and make us more conscious. It’s a move in the right direction, and imposes higher standards on all centres.”

SGH relocated its laboratory to ensure that sperm testing and sperm insemination are done at separate locations.

The spotlight was put on assisted reproduction centres a year ago, after The Straits Times reported on the IVF mix-up at the Thomson Medical Centre.

A Chinese Singaporean woman and her Caucasian husband had a baby after IVF, but noticed that it had a darker complexion. A test revealed that it had the woman’s DNA make-up, but not her husband’s.

The couple filed a complaint with MOH. Shortly after, the centre was suspended from taking in new patients, and later fined a maximum sum of $20,000 for failing to ensure that suitable practices were followed.

It was later revealed that the mix-up had occurred as the centre had processed two sperm specimens at the same workstation at the same time. 

Pipettes used at its fertility centre were also said to have been reused, instead of discarded. 

The centre’s suspension was lifted after about eight months, in June.

The couple’s lawyer, Mr S. Palaniappan, said the case has not been filed in court yet.

“We are still reviewing some issues together with MOH, including ascertaining the identity of the biological father,” he added.

A spokesman for Thomson Medical said it has implemented measures to meet the revised guidelines, and would continue to provide treatments to a smaller intake of new patients.


Key updates to the guidelines 

Personnel

A minimum of two, instead of one, authorised embryologists. 

Clinical practice

Husband has to be physically present when the centre receives his sperm specimen.

A doctor may submit an appeal to carry out assisted reproduction procedures for women aged 45 and above. Previous guidelines stated plainly that women of this age group “shall not be accepted into the AR programme”. 

No more than two – three, if certain conditions are met – embryos may be transferred into a patient’s body at any one time. Previously a maximum of four could be transferred, if some conditions were met.

Laboratory practices

Centres may only process sperm that is to be used for IVF or intra-uterine insemination (IUI). Sperm preparation and processing for IUI should be performed in a place separate from where sperm processing for IVF is done. 

Every specimen, test tube, pipette and other apparatus that comes into contact with specimens must be labelled clearly with the patient’s full name and a unique identifier.

Only one specimen from a single patient is processed at any one time at every stage of processing, unless it is an IVF or intracytoplasmic sperm injection with specimens belonging to the couple.