16 March 2010
Karen Devine is an associate lecturer and researcher at the University of Kent, specialising in the law of Obligations, with a particular interest in the social, legal and ethical implications of collecting and using UCB stem cellsAppeared in BioNews 550
Of course, in 2010, the ability to save umbilical cord blood (UCB) is more widely known, with over 15,500 collections being made last year alone (1). As UCB collection became more popular, the cells have been obtained by obliging health professionals, fathers and birth partners within the delivery suite, and you would think that given the introduction of the EU Human Tissue and Cells Directive (EUTCD) 2004, which was incorporated into UK law by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (2), tales of 'DIY car park collections' would be a dim and distant memory. As of July 2008, collections for private UCB storage can only be made by staff that have received specialist training in collection techniques, addressing the concern that the procured sample may be of insufficient quality to be useful for transplant purposes. Furthermore, fathers and birth partners are prohibited from being able to perform the procedure due to their lack of expertise. Indeed, studies carried out by the University of Minnesota in 2003 (3) and by the Institute of Medicine in 2004 (4) revealed that collection was more successful when performed by health professionals, and the Royal College of Obstetricians and Gynaecologists in a scientific opinion paper published June 2006 (5), reported that bacterial contamination rates fall when experienced, trained staff procure the cells.
The regulations also dictate that collections can only be made on premises that have been issued a licence by the UK's Human Tissue Authority (HTA), which has the authority to inspect the site to ensure its suitability for the procurement of quality cells and that best practice is being observed - and 'premises' presumably does not mean car parks! However, the HTA warned last week that despite the regulations, it has received an increasing number of reports that UCB collected for private storage and use is still being obtained outside of the legal 'rules'. First, it reported that midwives working in unlicensed hospitals are being pressurised into collecting the cells by parents desperate to save what has been billed by the cord blood industry as 'a lifetime of protection' (6). This is problematic because midwives - and the NHS trusts that employ them - can be prosecuted by the HTA if they engage in 'unlawful' collections and, in addition, they may face liability in negligence if they cause harm to the mother and/or baby or damage to the procured blood sample. Given that the very nature of the health profession/midwifery is to provide the very best care for pregnant women, it is easy to understand why midwives may feel morally obliged to acquiesce to their patient's requests for UCB collection and therefore inadvertently open themselves up to potential litigation. In fact, busy midwives may not even be aware that legal rules regarding collection exist and, perhaps more worryingly, may not be availed of the fact that the NHS Litigation Authority does not indemnify them if they perform unlicensed collection (7).
Secondly, it would appear that DIY collections do in fact continue in car parks. The HTA has written to over 150 organisations, including NHS trusts, parent associations and private UCB banks, to warn them that they are aware of at least 140 cases where collections have been made by those without any training and that, in at least one case, collection was made in the car park of the delivering hospital's grounds. This begs the question: what makes someone conduct a DIY medical procedure in such a precarious, unhygienic location? Put simply, it's either desperation or ignorance. Given the emotive marketing techniques deployed by the commercial UCB industry, parents may be persuaded to buy into the 'promise' of future health for their child by saving the cells with a private UCB bank - only to find that their attending midwife is not permitted to help them achieve their aim. It really is a postcode lottery whether the hospital that you deliver at is one of the few licensed to procure UCB. Having made the decision to spend in the region of £1,500 to privately store the cells, parents living in the 'wrong' area are then faced with the dilemma of either finding extra cash to pay for an independent nurse or phlebotomist to collect the cells, or to embark upon the risky business of DIY collection.
Of course, the pregnant woman has every right to ask for the expelled placenta to be given to a designated individual and, although the midwife can insist that the cells are not procured on the premises, she or he has little control over what happens to the placenta outside of the delivery suite. That said, there is little to stop birth partners from dabbling in a little DIY collection and, as time is of the essence, the hospital car park may seem as good a place as any. However, this smacks of an element of ignorance on the collector's part because there is a very good reason why UCB should be collected within a clean, clinical environment - contamination of the cells or the blood bag will render the sample useless and storage companies cannot accept cells that have been procured unlawfully. Either way, the paying UCB client is onto a loser.
The HTA is quite right to be concerned about unlawful collections and the problems they create for all concerned, and the authority appears to be taking its job as regulator seriously. It has always been my belief that the UCB collection process is an important part of the wider debate on UCB banking and, following this week's revelations, I am convinced that the problems surrounding collection remains an issue that cannot be ignored. The HTA's message is an important one and it is hoped that parents and others will take heed of the warning and that in the future, hospital car parks will once again become a placenta-free zone.