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Position statement on cord blood collection

HTA position statement on the collection (procurement) of umbilical cord blood.

Issued March 2010

Umbilical cord blood (cord blood) is collected at the time of birth and stored so that it may be available for potential future treatment of the child or another person.

The HTA regulates the collection (procurement) of cord blood in the UK under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations). The Q&S Regulations were established to ensure that the quality and safety of human tissues and cells (including cord blood) which may be used for treatment is maintained from the time of collection through to end use.

The collection of cord blood outside the HTA licensing framework is unlawful. The HTA uses its licensing framework to obtain assurance that suitable practices are being carried out by suitable people on suitable premises. Acting outside the licensing framework takes these assurances away from the HTA.

The Q&S Regulations and associated HTA Directions require any person collecting cord blood to be acting under the authority of an HTA licence or a Third Party Agreement (TPA). A TPA can be put in place between an HTA?licensed establishment and (a) an unlicensed establishment where cord blood is collected (such as a hospital), or (b) a person who is trained to carry out the collection on behalf of the licensed establishment. Whether the person collecting the cord blood is acting under a licence or a TPA, they must be appropriately trained to undertake the safe collection of the cord blood.

Training ensures that the person collecting the cord blood minimises the risk of physical harm to the mother and child, and protects the quality of the cells being collected so that they are suitable to use in treatment. If the person collecting the cord blood is not appropriately trained, or the premises are inappropriate, there is a risk that the safety and quality of the cord blood could be compromised because the potential for contamination increases.

Microbiological contamination should be determined by the establishment prior to long-term storage of the cord blood, and the parents informed of any positive contamination results so they can make a decision about the continued storage of the cells. Although some establishments may decide to store contaminated cord blood in quarantine conditions in the hope that it might one day be useful, other establishments may decide to refuse to store contaminated cord blood because of the risk of cross contamination of other samples and harm to the recipient if used.

Parents considering cord blood collection should ensure that appropriate arrangements are in place for the lawful collection of the cord blood by an appropriately trained person. Whilst the primary responsibility for compliance with HTA requirements lies with the licensed establishment, parents should ensure that they are familiar with the legal requirements and do not themselves act outside of the law (e.g. by asking an unauthorised midwife or birthing partner to undertake the collection). Cord blood collection, like any medical procedure, is not risk-free and it is essential that only trained, authorised personnel carry out procurement.

The HTA has written to HTA-licensed cord blood establishments, maternity units and third party collection companies to ensure they are aware of the requirements for the lawful collection of cord blood and the need to ensure that all parents considering collecting and storing cord blood are fully informed.

The HTA requires all unlawful cord blood collections to be reported to us by the Designated Individual of the licensed establishment. In addition, the licensed establishment should risk assess unlawfully collected samples to determine whether they should continue to be stored. The HTA can require the disposal of any unlawfully collected cord blood and may in certain circumstances decide to exercise that power.

 

Updated March 2010