UK's HTA voices concerns about unlawful cord blood collection

On Tuesday (9 March) the UK's Human Tissue Authority (HTA) took the unprecedented step of writing to more than 150 organisations to express our concerns that umbilical cord blood is being collected unlawfully, and that this activity may compromise safety and quality standards. Our letters were targeted at those we regulate, maternity units, professional bodies and others. We also issued a media release that urged prospective parents to plan for cord blood collection earlier in the pregnancy. This was widely reported in the broadcast media, and in specialist and parenting publications.

Since 5 July 2008, cord blood can only be collected under an HTA licence by suitably trained staff. At the time this regulation was introduced, we wrote a BioNews commentary (see link below) to explain how we had engaged stakeholders - including those storing and collecting cord blood - to shape the way we implemented the legislation. Central to this work was the introduction of third party agreements (TPAs).

TPAs allow trained specialists, acting under an HTA licence, to carry out cord blood collection in unlicensed maternity units. Many hospitals do not hold licences for cord blood collection, and parents wanting to collect it privately may need to book their own trained specialist with a TPA in advance of the birth. This is what happens in the vast majority of cases. However, in a small proportion, cord blood is collected in the absence of a TPA, which is unlawful.

Since the regulation came into force, 140 cases of unlawful cord blood collection have been reported to us. These fall into three main categories. First, there have been instances of health professionals who know about the regulation but are put under pressure by parents to carry out unlawful collections. Secondly, we know of health professionals who are unaware of the regulation and are carrying out unlawful collections and, third, we know there are instances where the parents are making the collections themselves.

One of the major aims of our communication this week is to raise public and professional awareness of the importance of regulation in protecting the safety of the mother and child. Some parents believe that cord blood collection is risk-free and we have heard of instances where they have put pressure on midwives and other healthcare professionals to collect cord blood unlawfully at third stage of labour. This could divert attention from the mother and child at a crucial time. It is essential that, if cord blood is collected, the procedure is planned and undertaken by a trained specialist in a way that does not interfere with delivery.

Another aim is to deliver a message that cord blood needs to be collected by a trained professional in a suitable environment to prevent contamination. We know that some parents do not consider collection to be a medical procedure, which may contribute to a perception that it does not matter where it happens or who collects it. In one case we became aware of, cord blood was collected in a hospital car park - the sample was contaminated and had to be disposed of. This sort of incident is likely to be distressing for parents, and may waste money. There are some very good online sources of information about cord blood collection for parents, for example on the websites of the NHS Cord Blood Bank, the Royal College of Midwives, the Royal College of Obstetricians and Gynaecologists and the Genetic Interest Group (.pdf 407KB).

We are encouraging parents to find out about cord blood collection earlier in pregnancy, to read around the subject and discuss it with their healthcare professional. This means that, should they decide cord blood banking is right for them, they will be fully informed of the risks and will have time to plan for a trained specialist to carry out the collection (if the hospital involved permits this). We hope that if this happens we will see a reduction in the number of cases of unlawful collection. Should this not be the case, we will consider what other action we should take.

For those with an interest in this area, the HTA has issued a position statement on cord blood collection and revised our web pages in this area. More information can be found on the HTA website.