Human Tissue Authority

The regulator for human tissue and organs

Organ donation and transplant FAQs

Please see below for a number of frequently asked questions from a specific category. Simply select one of the questions of interest, the answer will then appear below. For the complete list of categories please visit the main FAQs page.

An organ is a differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with a significant level of autonomy. A part of an organ is also considered to be an organ if its function is to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation for example, a liver lobe.  

Composite tissue is a construct that contains multiple structures that may include skin, bone, muscles, blood vessels, nerves and connective tissue, that is recovered from a donor as an anatomical or structural unit, without altering its relevant characteristics. Composite tissue requires its own blood supply and can be transplanted to an appropriate recipient. Composite tissue falls within the HTA’s ODT framework and examples of composite tissue for transplantation include, face, hand and leg.

The European Union Organ Donation Directive (2010/53/EU) (EUODD) required Member States to identify a Competent Authority to oversee the requirements of the Directive.

In 2011, the UK Government, and the devolved Governments appointed the Human Tissue Authority (HTA) as the Competent Authority for the EUODD in the UK.

The requirements set out by the Directives have been enshrined into UK law through The Quality and Safety of Organs Intended for Transplantation Regulations 2012 and The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014.The HTA has implemented a regulatory framework ‘The Quality and Safety of Organs Intended for Transplantation – a documentary framework’ (PDF) to provide guidance to professionals on how the quality and safety standards of the EUODD should be met.

The HTA has put in place a service level agreement with National Health Service Blood and Transplant (NHSBT) to assist with the following Competent Authority functions: Supervision of the exchange of organs; to keep records and make reports relevant to procurement and transplantation centres; and to keep a register and to follow up living donors.

The agreement with NHSBT also includes the requirement for the management, reporting and investigation of serious adverse events or adverse reactions (SAEARs). Any SAEAR that may influence the quality and safety of organs must be reported to NHSBT within 24 hours of discovery. NHSBT acts on behalf of the HTA to carry out an investigation into the incident and submit their findings to the HTA for consideration.

The regulations require that activities involving procurement and transplantation are licensed. The activity of procurement includes one or more of the following: donor characterisation, organ characterisation, preservation of an organ, making arrangements to transport an organ and retrieval of an organ. The activity of transplantation includes organ characterisation, preservation of an organ, making arrangements to transport an organ and implantation of an organ. Further information on the definitions of these activities can be found in ‘The Quality and Safety of Organs Intended for Transplantation – a documentary framework’ (PDF)

If you carry out, or intend to carry out, one or more of the above activities you require a licence from the HTA to do so. Multiple activities, covering both procurement and transplantation, can be carried out under a single licence. A licence application can be made electronically by using the form via the HTA web Portal. You will need to register as a user before you can access the application form. The licence application must state which activity or activities are planned.

 

The HTA prefers that the licence holder is the corporate body where possible (e.g. an NHS Trust). Establishments applying as a corporate body should provide the contact name of an individual who will act as a representative for the corporate body (Corporate Licence Holder Contact [CLHC]). It is a statutory requirement that the licence holder ensures compliance with the:

  • Conditions of the licence;
  • HTA directions imposed on the licence

Licences granted under the Human Tissue (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 (The Regulations) apply to corporate bodies and persons rather than to premises. This means that licensed individuals, or staff employed by licensed corporate bodies, such as NHS Trusts or NHSBT, can undertake licensed activities in a range of locations that are authorised by their employer.

Example:

A National Organ Retrieval Service (NORS) team is authorised to carry out licensable activities, such as procurement, under the licence of the establishment where they are based, regardless of the premises on which they carry out the licensable activities. For example a Newcastle NORS team that carry out licensable activities e.g. procurement in Staffordshire will be doing so under the Newcastle ODT licence. 

Although NHSBT keeps a register of all living donors for follow-up, all transplant centres are required to keep this information on site. Local practice will vary depending on how follow-up clinical visits, or visits to local GPs or hospitals are managed. Paragraph 23 of the EU Directive (2010/45/EU) on standards of quality and safety of human organs intended for transplantation ‘states that the highest possible protection of living donors should be ensured.’

Donors should be followed up to identify any reactions or disease processes which may have potential consequences for both organ recipients and living donors. For overseas donors, both the donor and the managing general practitioner should be informed by information provided in discharge letters of reporting any serious adverse events or reactions to the transplant centre.
 

Example:

  • if a living kidney donor develops a tumour, the transplant centre should be informed to ensure that the organ recipient is appropriately monitored

You are required to notify the HTA with details about any changes to licensable activities, organ types, establishment address or location details.

Examples of changes you must notify the HTA about include:

  1. We would like to add another organ or composite tissue to our list
  2. We would like to remove an organ from our list
  3. The licence holder (Trust) has changed
  4. The licence holder (contact) has changed
  5. The licence holder address has changed

Changes to your licence must be submitted via licensing.enquiries@hta.gov.uk  

The above list is not exhaustive; please contact the HTA if you are unsure of whether a change at your establishment needs to be submitted as a licence change. Changes to licenses will be considered on a case by case basis.

Information about fees for this sector can be found on the fees and payments page.

An on-site audit aims to review operational policies, procedures and practices in place. The audit involves a visual inspection of the premises, a review of documentation and discussions with a range of staff involved in licensable activities. This enables the HTA to identify any shortfalls against the assessment criteria and the conditions of the licence. We also offer advice and guidance on areas requiring further improvement as well as identifying areas of good practice. 

The EUODD does not specify how frequently audits should occur. The EUODD requires that ‘procurement organisations and transplantations centres are controlled or audited on a regular basis’. A number of considerations are factored in to deciding which establishments are prioritised for audit; these include, for example, the results of compliance updates. The HTA develops its ODT compliance updates to take into consideration information gathered following submission of serious adverse events and reactions and shortfalls identified during audits.

All establishments will be given three months notice of a routine planned onsite audit.

A comprehensive suite of National Operating Procedures (NOPs) are available on the NHSBT microsite. There are NOPs covering:

  • Donor and Organ Characterisation Assessment and Allocation in Deceased and Living Donation and Transplantation
  • Verification of Donor Identity Consent and Authorisation Organ and Donor Characterisation in deceased and Living Donation and Transplantation
  • Packaging Labelling and Transport of Organs in Deceased and Living Donation and Transplantation
  • Management of Procurement Material and Equipment in Deceased and Living Donor and Transplantation
  • Activities to be Performed Under the Guidance of a Registered Medical Practitioner
  • Transfer and Storage of Donor and Organ Characterisation Information and Storage of Traceability Data

The NOPs contain mandatory information which must be documented in local operating procedures, in order to meet HTA assessment criteria. Where establishments do not already have equivalent procedural documentation in place, they are encouraged to adapt the NOPs in line with the establishment’s local procedures to ensure that they reflect how activities are carried out locally. 

The NOPs must be adopted with local amendments as appropriate or alternative procedures must be developed which meet the regulatory requirements. The documentary framework document provides information about these requirements. 

 

Yes. There must be consent for research in place from the donor or a person in a qualifying relationship to the donor immediately before their death.

If organs are removed for the purpose of transplantation by a NORS teams and found unsuitable for transplantation, they can be removed for a scheduled purpose such as research under the Human Tissue Act. A separate removal licence is not required.

If the organs are removed for research only, the establishment must have a HTA licence for removal for research under the Human Tissue Act. Most Post Mortem establishments already hold this licence which can be extended by the HTA, to cover other areas where removal of tissue from the deceased takes place. Designated Individuals are advised to contact the HTA if they wish to extend a licence to cover theatres to enable this activity to take place.

For more information please refer to paragraphs 56-57 of the documentary framework document and the HTA website.  

A serious adverse event (SAE) is defined in the Regulations as ‘any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity’.

SAEs that may influence the quality and safety of an organ and that may be attributed to the testing, characterisation, procurement, preservation and transport of organs must be reported and investigated. The HTA also requires that any SAEs which occur at a transplant centre which may influence the quality and safety of an organ must be reported and investigated.

A serious adverse reaction (SAR) is defined in the Regulations as ‘an unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity’. SARs observed during or after transplantation which may be connected to the testing, characterisation, procurement, preservation and transport of organs must be reported and investigated. 

It is a statutory condition of an ODT licence to report SAEARs to NHSBT on behalf of the HTA within 24 hours of discovery of the incident by the licence holder. Establishments should have in place operating procedures for the management of a serious adverse event or a serious adverse reaction. 

The HTA directs, that for living donation, only CPA or UKAS accredited laboratories should be used, unless by doing so there is a risk to the donor or recipient which would outweigh the risk of using a non-accredited laboratory or one with an unknown status, e.g. due to time constraints in an emergency liver donation.

For deceased donation, establishments should endeavour to use only laboratories accredited by CPA or UKAS. The HTA would expect licence holders to establish the accreditation status of laboratories that are frequently used for donor or organ characterisation, and to review and update this information on a regular basis. Where CPA or UKAS accredited laboratories are not available, a risk assessment of the testing laboratory should be performed and the implanting surgeon should be informed. The results of the risk assessment should be recorded in donor files.

In the context of testing, examples of SAEs may be related to mislabelling, transcription errors, loss of traceability of samples, failure in testing protocols etc. All incidents should be reported to NHSBT. NHSBT will then report incidents falling into the category of SAEARs to the HTA.

Testing laboratories are not licensed by the HTA and should report SAEs to the licence holder, who will then submit a report to NHSBT. Further guidance is provided in the SAEARs Guidance Document (PDF).