Third Party Agreement FAQs

This page contains frequently asked questions about Third Party Agreements. This information is only applicable to establishments within the human application sector.

What is a Third Party Agreement?

The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (the Regulations) define a Third Party Agreement (TPA) as:

“An agreement in writing between a licence holder (or the designated individual on behalf of the licence holder) and another person, which is made in accordance with any directions given by the Authority under section 23(1) of the 2004 Act for the purpose of securing compliance with the requirements of Article 24 of the first Directive (relations between tissue establishments and third parties), and under which the other person;

(a) carries out licensed activity (other than storage) on behalf of the licence holder, or
(b) supplies to the licence holder any goods or services which may affect the quality or safety of tissue or cells”.

A TPA may be used to provide a third party with the authority to undertake licensable activities on behalf of a licensed establishment. For this reason, there are stringent criteria that a TPA must meet, set down in paragraph 118 of HTA’s Directions 002/2007.

For TPAs where a person or establishment is supplying to the licence holder any goods or services which may affect the quality or safety of the tissues or cells, the requirements for the TPA are contained in paragraph 119 of HTA’s Directions 002/2007.

What is a Service Level Agreement?

A Service Level Agreement (SLA) is an agreement that sets out the roles and responsibilities of two parties. An SLA cannot be used to provide a third party with the authority to undertake licensable activities on behalf of a licensed establishment, and is not sufficient for governing the supply of goods or services which may affect the quality or safety of tissues and cells.

If two establishments are licensed by the HTA and one undertakes licensable activities on behalf of the other, an SLA setting out roles and responsibilities is sufficient to document the working relationship between the two licensed establishments.

What are Relevant Third Party Premises (RTPP)?

• Any premises on which a third party (TP) procures, tests, processes, distributes, or to which a TP imports, or from which a TP exports, tissue and/or cells on behalf of any person authorised by a licence to carry on that activity, or
• Any premises from which a TP provides any goods or services which may affect the quality and safety of tissue or cells to any person in connection with licensed activities carried on by that person.

Can a TP undertake all licensable activities on behalf of an establishment?

No, storage of tissue and cells cannot be undertaken by a third party under a third party agreement. All other licensable activities can be; however, all the activities must be specifically described in the agreement and must be authorised by the licensed establishment’s licence.

Can an establishment have a TPA with another hospital within the same NHS Trust?

No. A TPA is defined as being between an establishment and another person (including corporate entity) i.e. between two distinct legal entities. If an NHS Trust is the licence holder, it cannot have a contractual agreement in place with itself, even if such agreement would be on behalf of another hospital in the same Trust.

When licensed activities are carried out by a TP within the same NHS Trust, the Licence Holder could consider putting individual TPAs in place with TP staff, or applying for a satellite licence (see satellite premises page).

What must a TPA include?

The full requirements for TPAs are set down in paragraphs 118 and 119 of HTA’s Directions 002/2007.

As a Designated Individual (DI), do I need to let the HTA know if I have a TPA in place?

Yes. It is a requirement under the HTA Directions to provide information to the HTA about what TPAs you have in place. The HTA asks all DIs to provide the HTA with details of all TPAs that are in place where the TP is carrying out procurement, processing, testing, distribution and import/export of tissues and cells for human application on your behalf.

NB: DIs will be considered to be in breach of the standard condition on all Human Application licences issued by the HTA if you fail to report third party agreements to the HTA. This may result in regulatory action being taken.

I am a Designated Individual/Licence Holder, how can I fulfill my reporting requirements about TPAs?

You should complete the Third Party Agreement submission form on the left of this page and submit to licensing@hta.gov.uk  

You will be asked to provide full details about the third party, the activities carried out by the third party and confirm that these activities are taking place under a third party agreement.

How should DIs manage records that are related to activities covered by a TPA?

Records must:

• comply with SOPs for records management. These SOPs should be provided to the third party by the DI of the licensed establishment
• be intact, complete and legible
• facilitate traceability from donation to end use
• be stored securely
• remain confidential (restricted access)
• provide for execution of duties in relation to disclosure of information (as per the Regulations)
• be retained/maintained in line with reported activities taking place under a TPA as part of an annual activity report to the HTA

How long must I retain documentation and records of activities undertaken by TPs?

All documentation and records to facilitate the traceability of donors must be retained for 30 years after the cells are used or disposed of. This includes donor identification, product identification, identification of the supplier establishment clinician or end user, tissue/cell type, date of application, identification of the recipient (paragraph 71, Directions 002/2007) and donor records (paragraph 36, Directions 001/2006)

All records, including raw data, critical to activities that may affect the quality and safety of tissues and cells must be retained for 10 years after use or disposal of the cells. Provisions must be in place in any TPA to ensure that records are transferred to a licensed establishment in the event of termination of activities.

What are the requirement for transfer of tissue and / or cells and records when terminating a TPA?

The TPA must include provision of the transfer of any tissues and cells to a HTA-licensed establishment (paragraph 118 (ccc), Directions 002/2007). There must also be a documented process for the transfer of records from the TP to the licensed establishment (paragraph 118 (nn), Directions 002/2007).

How are TPs made aware of regulatory alerts from the HTA?

It is the responsibility of the Designated Individual of the licensed establishment to communicate information to TPs, including regulatory alerts and other relevant communications from the HTA regarding serious adverse events and reactions (SAEARs).

What should the TP do if an adverse incident occurs during the carrying on of the licensable activity?

Specific obligations for the third party reporting of adverse events and reactions should be detailed in the TPA, either directly or by provision of an SOP from the DI of the licensed establishment. These obligations include;

• a system for reporting the event to the DI of the licensed establishment
• a system for investigation, including risk assessment and internal audit
• a process for escalation and reporting to the HTA if the event is deemed serious

What should the DI do if an adverse incident is reported by a TP acting on behalf of his/her establishment?

The DI of the licensed establishment is responsible for assessment and documentation of the adverse incident occurring under the licence, and reporting of any serious adverse event or reaction to the HTA and any other affected establishments.

The DI should:

• assess the seriousness of the incident
• investigate the incident
• document the reporting, assessment, evaluation and investigation of the incident
• retain all documentation related to investigation of the incident
• if deemed serious, notify and report the adverse event or reaction to the HTA and to  personnel within establishment and other establishments
• if appropriate, effect a recall of the implicated tissues and / or cells

What additional responsibilities will the establishment and any TPs have once a Serious Adverse Event or Reaction (SAEAR) is reported?

The establishment and the TP must make available to the HTA (on request) all records related to SAEAR and aid in any investigation process. This process must be clearly specified in the TPA. The DI should also ensure the retention of records related to the SAEAR once provided to the HTA, including any follow up reports.

What are the duties of the DI regarding activities that take place under TPAs?

The full requirements for DIs are set down in paragraphs 4 of HTA’s Directions 001/2006 and paragraphs 11 and 12 of HTA’s Directions 002/2007.

How do I assure myself as DI that the premises at which the TP activity takes place is appropriate for the activity?

• ongoing audits of the procedures, facilities and personnel
• risk assessments of the premises and activities being carried out under the licence
• periodic review of the TPA to ensure it remains fit for purpose
• provision of a pro forma for risk assessing risks that may arise on an ad hoc basis
• ongoing review of SOPs for maintenance of premises and facilities
• ensure controlled access and security measures
• ensure that appropriate back-up and emergency clinical facilities (if appropriate) are in place
• review environmental monitoring, air quality and other critical processing parameters 
• provide and / or review the appropriateness of garments and equipment for personal protection and hygiene

Does a DI need to carry out periodic audits of the activities that take place under a TP?

Yes. In addition, the DI must be allowed access to the facilities, RTPPs, documentation and records, including audit of the premises and practices of the TP. This will allow the DI to ensure that suitable practices are being carried out and that the conditions of TPAs are being complied with.

DIs should also be aware of their specific duties under Regulation 12 of the Human Tissue (Quality & Safety for Human Application) Regulations 2007 and the relevant provisions under Paragraph 12 of Directions 002/2007.

How do DIs fulfil their obligation to report TPAs to the HTA?

• provide details in the HTA Compliance Report when applying for a licence
• report TPAs as part of annual activity data