Third party agreements
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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 out in the Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment (the Guide).
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 paragraphs 236-237 of the Guide.
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.
- Any premises on which a third party procures, tests, processes, distributes, or to which a third party 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 third party provides any goods or services which may affect the quality and safety of tissue cells for patient treatment in connection with licensed activities carried out on that person.
No, storage or import 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.
No. A third party agreement (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 (LH), 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 third party within the same NHS Trust, the LH could consider putting individual TPAs in place with third party staff, or applying for a satellite licence.
The full requirements for TPAs are set down in paragraphs 238-240 of the Guide.
The Licence Holder (LH) and Designated Individual (DI) of the licensed establishment should also refer to paragraph 239a of the Guide, which states that “agreements with third parties must specify the terms of the relationship and responsibilities as well as the protocols to be followed to meet the required performance specification”. The LH and DI should evaluate what parts of paragraphs 238 and 239 are applicable on the basis of the relationship between themselves and the third party.
- 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; and
- provide and / or review the appropriateness of garments and equipment for personal protection and hygiene.
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 provision to conduct audits of third party premises at two yearly intervals as set down in the Guide.
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 us with details of all TPAs that are in place where the TP is carrying out procurement, processing, testing, distribution and 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 tissue and cells for patient treatment (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.
You should complete the online form by using the TPA submission form.
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. The completed TPA submission form should be sent to the HTA Licensing Team: email@example.com.
- comply with Standard Operating Procedures (SOPs) for records management. These SOPs should be provided to the third party by the Designated Individuals 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); and
- be retained / maintained in line with reported activities taking place under a third party agreement as part of an annual activity report to the HTA.
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.
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.
The third party agreement (TPA) must include provision of the transfer of any tissues and cells and there also be a documented process for the transfer of records from the third party to the licensed establishment. (paragraphs 267-270 of the Guide).
It is the responsibility of the Designated Individual of the licensed establishment to communicate information to third parties, including regulatory alerts and other relevant communications from the HTA regarding serious adverse events and reactions (SAEARs).
Specific obligations for the third party reporting of adverse events and reactions should be detailed in the third party agreement, either directly or by provision of a standard operating procedure from the Designated Individual 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; and
- a process for escalation and reporting to the HTA if the event is deemed serious.
The Designated Individual (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 the establishment and other establishments; and
- if appropriate, recall the implicated tissues and / or cells.
The establishment and the third party must make available to the HTA (on request) all records related to a SAEAR and aid in any investigation process. This process must be clearly specified in the third party agreement. The Designated Individual should also ensure the retention of records related to the SAEAR once provided to the HTA, including any follow up reports.