Cord blood procurement
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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.
In the UK, procurement of human tissues and cells which may be used for treatment (including cord blood) must occur on HTA-licensed premises or under a third party agreement (TPA). In the latter case:
- the procurer must be procuring cord blood on behalf of an HTA-licensed establishment; and
- the TPA must meet the requirements set out in the HTA’s Guide to quality and safety assurance of human tissues and cells for patient treatments.
The two types of TPA that may be suitable for the procurement of cord blood are:
- a TPA between an HTA-licensed cord blood establishment and the hospital whose staff will carry out the procurement; or
- a TPA between the HTA-licensed cord blood establishment and an individual procurer, e.g. an independent phlebotomist, who will carry out the procurement.
The HTA has produced a guidance document for establishments licensed by the HTA to undertake activities related to the procurement, testing, processing, storage, distribution, import and export of umbilical cord blood cells . This document will raise awareness of how the legislation relates to these establishments and provide advice on areas which are specific to cord blood and related tissues.
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 002/2018, 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.
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 002/2018, 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. These guidelines state that: -
'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.
The definition of procurement for the purposes of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) (as amended) is quite wide. Regulation 5(2) of the Q&S Regulations makes it clear that (unless otherwise provided for in the Regulations), words and expressions used will have the same meaning as in Article 3 of EU Tissues and Cells Directive 2004/23/EC. Article 3 states that "'procurement' means a process by which tissue or cells are made available".
The provision of cord blood collection kits to clients therefore falls within the definition of procurement, since it is a part of the process by which tissues or cells are made available. Procurement is a licensable activity under the Q&S Regulations. The advertisement and distribution of cord blood collection kits is also included in the definition of ‘procurement'.
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.
The HTA has produced a guidance document for establishments which the HTA licences to undertake activities related to the procurement, testing, processing, storage, distribution, import and export of umbilical cord blood cells (you can download a copy of this document on the left side of this page). This document will raise awareness of how the legislation relates to these establishments and provide advice on areas which are specific to cord blood and related tissues.