Establishments involved in cord blood collection

a)   Where the cord blood is procured on:

1. premises that are unlicensed by the HTA; and
2. premises that are not the subject of a TPA with a licensed establishment; and

b)     the umbilical cord blood is procured by a person acting in pursuance of a TPA with a licensed establishment.

The HTA’s guide to quality and safety assurance for human tissues and cells for patient treatment as implemented by Directions 001/2021 require the procurer to ensure that RTPP are suitable for the activity that will be undertaken.

The DI at the licensed establishment should satisfy themselves of the suitability of the premises by requiring the procurer to undertake a documented assessment of the RTPP prior to collection of cord blood. (For RTPP where multiple procurements will occur, a documented assessment must be undertaken prior to the first collection on those premises, and after any significant change to the premises or processes that may affect the risks of procurement.)

The assessment should be received by the licensed establishment prior to, or at the same time as the cord blood is received, but prior to the acceptance of the cord blood into the licensed establishment. The cord blood should be quarantined until such time as the assessment has been reviewed by the DI of the licensed establishment, who can then decide whether to accept or dispose of the cord blood.

Where cord blood is procured on:

1. premises that are licensed by the HTA; or
2. premises that are the subject of a TPA with a licensed establishment (i.e. RTPP); and
3. the licensed establishment is unsure of the training of the individual procurer;

then the DI of the licensed establishment receiving the cord blood must quarantine the cord blood and seek assurance from the procurer that they have been appropriately trained to collect cord blood in compliance with the licensed establishment’s procedures.

If the DI of the licensed establishment is satisfied that the procurer is suitably trained, this assessment must be documented and the record retained before the cord blood can be removed from quarantine.

Where the DI is not satisfied that the procurer is suitably trained, the DI is responsible for reporting this to the HTA as an SAE in accordance with the paragraphs below.

It is an offence under the Human Tissue Act 2004 (HT Act) and the Q&S Regulations if cord blood is procured:

1. on premises that are unlicensed by the HTA
2. on premises that are not the subject of a TPA with a licensed establishment
3. by a person who is not acting in pursuance of a TPA with a licensed establishment

The DI is responsible for reporting this to the HTA as an SAE in accordance with the paragraphs below.

This section applies to cord blood collected under Scenarios 2 and 3 described above.

The DI at the licensed establishment receiving the cord blood is responsible for reporting any SAEs to the HTA via the SAEARs reporting mechanism. Each SAE report will be assessed by the HTA on a case-by-case basis, as with all other SAE reports.

The DI at the licensed establishment receiving the cord blood must ensure that the cord blood is quarantined and a documented risk assessment for the continued quarantine storage of the cells is undertaken. The cord blood must remain in quarantine while the establishment completes their investigation and implements any improvement measures.

Records relating to any unlawful procurement or procurement by an untrained individual must be retained by the licensed establishment and provided to the HTA as part of the SAE report. The records must include (as a minimum) the following information:

• date of the procurement;
• name and contact details of the procurer;
• location of the procurement; and
• the circumstances leading to the procurement

As part of its regulatory processes, the HTA will determine what, if any, action will be taken with regards to the procurer or the establishment receiving the cord blood. The HTA can require the disposal of any unlawfully collected cord blood and may in certain circumstances decide to exercise that power.

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 (as amended) (the 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 removes these assurances.
 
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 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.
 
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 Human Tissue Authority (HTA) regulates the 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 HTA does not licence the end use of cord blood in medical treatment.

Establishments distributing cord blood for end use must comply with the requirements of the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by HTA Directions 001/2021, which include provisions for traceability and reporting of serious adverse events and reactions.

The Royal College of Obstetricians and Gynaecologists (RCOG) have produced guidelines on cord blood banking. The HTA endorses these guidelines.

'Cord blood must be collected safely. It is important that:

• A trained technician who is not involved in your care or your baby's care collects the cord blood. It is important that neither your obstetrician nor your midwife is distracted from looking after you and your baby during and immediately after childbirth.
• There should be no alteration in your ‘usual management' of labour, such as the delivery of the placenta or clamping of the cord. Some evidence indicates that immediate cord clamping may be harmful to babies. However, delaying cord clamping can prevent a successful cord blood collection.
• Cord blood should be collected after the placenta has been delivered in a clean environment using methods and facilities, which meet the required regulations including the EU Tissue and Cells Directive.'

Please refer to the RCOG’s website for further information.

Under the Q&S Regulations, storage is defined as "maintaining tissues or cells, whether by preservation or in any other way, for more than 48 hours". Since cord blood will normally be stored in the cord blood establishment for more than 48 hours a HTA licence is required.

It is not possible to use a third party agreement to delegate the licensable activity of storage to a third party. Regulation 7(1) of the Regulations makes it unlawful to store cord blood intended for human application other than under the authority of a HTA licence.

Not necessarily. In addition to collection being undertaken on licensed premises, the procurement of cord blood can also be undertaken by:

• a healthcare professional who has (a) completed training to the approval of the Designated Individual named on a cord blood establishment’s HTA licence, and (b) has entered into an individual third party agreement with an HTA licensed cord blood establishment; or
• by a healthcare professional who has (a) completed training to the approval of the Designated Individual named on a cord blood establishment’s HTA licence, and (b) is working for a hospital who holds a third party agreement with an HTA-licensed establishment.

If the premises where procurement will take place are not licensed by the HTA, the procurer must ensure an appropriate third party agreement is in place with a HTA-licensed cord blood establishment prior to procuring the cord blood.

The patient’s chosen cord blood establishment is responsible for issuing third party agreements and setting out the terms under which the cord blood can be procured. A compliant third party agreement will include provisions relating to consent, training, transport and packaging of the cord blood, record keeping and disposal.

Please note that when cord blood is collected on premises under a third party agreement, the premises where the cord blood will be collected (e.g. delivery suite or private home) become 'Relevant Third Party Premises' (RTPPs). There is a legal requirement that RTPPs are suitable for the activity to be undertaken – in this case the procurement of cord blood. An HTA-licensed establishment issuing a Third Party Agreement has a legal duty to satisfy themselves that RTPPs are suitable by requiring the procurer to assess the RTPP prior to collection of cord blood. In addition, the HTA has the power to inspect any RTPPs.

If a hospital does decide to allow an external phlebotomist on-site to procure cord blood, it should assure itself that the phlebotomist is working under a third party agreement with an HTA-licensed establishment.

We recommend that hospitals have systems for confirming that a Third Party Agreement is in place between an HTA-licensed establishment and the procurer before allowing cord blood to be collected. This might be achieved by updating the hospital’s policy to state that private cord blood establishments must provide the hospital with written notification of who the third party is and confirm that a Third Party Agreement in line with the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by HTA Directions 001/2021, is in place.

Not usually. This would only be possible if the patient’s partner was a registered healthcare professional trained in the collection of cord blood and acting under a third party agreement with an HTA-licensed establishment.

The requirement for an HTA licence is not dependent on the amount of activity, but on whether an activity is ever carried out. If your establishment is involved, or wants to become involved, in the collection of cord blood intended for future treatment then you will require an HTA licence.

Alternatively, a third party agreement could be put in place for the lawful procurement of the cord blood (please see FAQ 'A patient has approached me to collect cord blood during the delivery'). In this situation the hospital would not require a licence.

Training ensures that the person collecting the cord blood is competent to undertake cord blood collection. Training will ensure that the risk of physical harm to the mother and child during the cord blood collection is minimised and that processes are followed to reduce the possibility of the cord blood being contaminated during collection.