The Designated Individual (DI) at the licensed establishment is responsible for ensuring suitable practices take place under the authority of the Human Tissue Authority (HTA) licence. As procurement of cord blood is usually undertaken on Relevant Third Party Premises (RTPP) under a third party agreement (TPA), DIs must develop robust procedures to assure themselves that cord blood is appropriately procured, received, quarantined and risk assessed prior to acceptance into the establishment.
The HTA has produced a position statement, guidance document and FAQs for establishments which it licenses 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.
In addition to publishing this guidance document, 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 the collection and storage of cord blood are fully informed.
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 with an HTA-licensed establishment. The HTA Directions also require the procurer to be appropriately trained to the satisfaction of the DI to undertake the safe collection of the cord blood. The requirement for training of procurers is set down in paragraph 95 of the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by Directions 003/2010.
Collection of cord blood by untrained personnel may increase the risk of physical harm to the donor (in this case, both the mother and child). Additionally, collection of cord blood by untrained personnel, or on unsuitable premises, increases the risk of contamination of the cord blood. Microbiological contamination could lead to the cells being disposed of prior to storage, which would therefore not be available for future use, or otherwise harm the recipient if contaminated cells are transplanted in the future.
The HTA uses its licensing framework as an assurance that suitable practices are being carried out by suitable people on suitable premises, under the supervision of a DI. Acting outside of this framework takes these assurances away from the HTA.
The HTA considers that unlawful procurement of cord blood (that is, procurement of cord blood on premises unlicensed by the HTA where an appropriate TPA is not in place) to be a Serious Adverse Event (SAE) as it could have implications for other patients or donors because of shared practices, services, supplies or donors.
The HTA also considers procurement of cord blood by untrained personnel, whether undertaken unlawfully or under the authority of an HTA licence or TPA, to be an SAE for the same reason as described in paragraph 7 above.
The HTA requires all SAEs to be reported via the Serious Adverse Events and Reactions (SAEARs) reporting mechanism, available on the HTA’s website.
Receipt of cord blood into an HTA-licensed establishment
DIs must ensure that robust receipt procedures are in place to verify that cord blood has been lawfully procured by a person who is trained to the DI’s satisfaction. DIs should refer to paragraphs 116-224 of the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by Directions 003/2010 for the HTA’s requirements for tissue and cell receipt.
Scenario 1: Cord blood procured under a TPA between the licensed establishment and a trained individual
a) Where the cord blood is procured on:
i) premises that are unlicensed by the HTA; and
ii) 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 treatments as implemented by Directions 003/2010 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.
Scenario 2: Cord blood procured under a licence / TPA where the procurer’s training is unknown or absent
Where cord blood is procured on:
- premises that are licensed by the HTA; or
- premises that are the subject of a TPA with a licensed establishment (i.e. RTPP); and
- 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.
Scenario 3: Unlawful procurement of cord blood
Where cord blood is procured on:
- premises that are unlicensed by the HTA; and
- premises that are not the subject of a TPA with a licensed establishment; and
- the cord blood is procured by a person who is not acting in pursuance of a TPA with a licensed establishment,
then the cord blood is procured unlawfully and the procurement is an offence under the Human Tissue Act 2004 (;T Act) and the Q&S Regulations. 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.
Updated November 2010