Human Tissue Authority

The regulator for human tissue and organs

Third party agreements

Further information on Third party agreements (TPAs) can be found here.

The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) 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 on licensed activity (other than storage or import into the United Kingdom from a third country) 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 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.

Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended), relevant third party premises in relation to a licence under Schedule 1, mean any premises (other than premises to which the licence relates):

  • on which a third party procures, tests, processes or distributes, or from which a third party exports from the United Kingdom to a third country, tissue or cells on behalf of any person authorised by a licence to carry on that activity; or
     
  • from which a third party provides any goods or services which may affect the quality or safety of tissue or cells to any person in connection with licensed activities carried on by that person; and
     
  • ‘third party’ means a person with whom a licence holder has a third party agreement.

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, if the licensable activity is to be carried out by an individual or applying for a satellite licence.

The full requirements for TPAs are set down in paragraphs 238-239 of the Guide

Regarding paragraph 239 b(vii), Licence Holders and Designated Individuals should ensure that Third Party Agreements include specific instructions relating to the reporting time frames for serious adverse events and reactions (SAEARs); more information on this can be found in paragraph 217 of the Guide. 

The full requirements for DIs are set down in paragraphs 1-4 of the Guide and specific requirements for the DI pertaining to TPAs are set down in paragraphs 234-235 of the Guide.

  • 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.

The reporting requirements relating to third parties carrying out licensable activities under the terms of a third party agreement are set out in paragraphs 232-235 of the Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment.

It is a standard condition of HTA human application licences that where a third party agreement is entered into by the Licence Holder, or the Designated Individual on behalf of the Licence Holder following the grant of a licence, then the Licence Holder, or the Designated Individual must first notify the HTA and the HTA must be satisfied as to the suitability of the proposed relevant third party premises before any licensed activity is carried out by the third party on behalf of the Licence Holder.

The HTA’s TPA submission form should be used to notify the HTA of new third party agreements.

Records must:

  • 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).

The requirements and procedures for reporting adverse events and reactions that occur at third parties should be clearly documented. This may be achieved though the inclusion of detailed information on incident reporting in third party agreements, or through the sharing of standard operating procedures (SOPs) for incident reporting that have been generated, and are controlled by, the licensed establishment. If the latter approach is adopted, the relevant SOPs should be clearly referenced within the third party agreement. 

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, including any follow up reports.