Third party agreements FAQs

A TPA is defined in the HTA Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment as:

An agreement in writing between a Licence Holder, or the Designated Individual on behalf of the Licence Holder, and another person or corporate body who do not hold a HTA licence for human application. A TPA is entered into for the purpose of securing adherence to the specified requirements of the Regulations, and under which the other person:

a) carries on a licensed activity (other than storage or import from a third country), on behalf of the Licence Holder. For example, if they procure, process, test, distribute, or export tissues and/or cells 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. A SLA cannot be used to provide an unlicensed 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, a SLA setting out roles and responsibilities is

sufficient to document the working relationship between the two licensed establishments.

A third party is defined in the HTA Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment as:

A person or corporate body with whom a Licence Holder, or the Designated Individual on behalf of the Licence Holder, has a TPA. A third party is defined here as an entity which is not licensed for human application by the HTA.

A third party premises is defined in the HTA Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment as:

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 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.

No. A TPA is defined as being between an establishment and another person (including corporate entity) - i.e. between two distinct legal entities. If a 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.

The full requirements for TPAs are set down in paragraphs 238-239 of the HTA Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment.

Regarding paragraph 239 b(vii), Licence Holders and Designated Individuals should ensure TPAs include specific instructions relating to the reporting time frames for serious adverse events and reactions; more information on this can be found in paragraph 217 of the HTA Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment.

No. Storage or import of tissue and cells cannot be undertaken by a third party under a TPA. 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.

The full requirements for Designated Individuals are set down in paragraphs 1-4 of the HTA Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment. Specific requirements for the Designated Individual pertaining to TPAs are set down in paragraphs 234-235.

The list below gives examples of how Designated Individuals could seek assurance the premises at which the third party 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 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 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.

This list is not exhaustive and the Designated Individual is responsible for determining appropriate processes for obtaining the required information.

Yes. Where the third party carries out processing, regular full audits should be carried out at least at two yearly intervals. In addition, and applicable to all activities carried out under the TPA, the Designated Individual must be allowed access to the RTPPs and relevant documentation (e.g. records, audits of the premises and

practices of the third party etc.). This will allow the Designated Individual to ensure suitable practices are being carried out and the conditions of TPAs are being complied with.

Designated Individuals should also be aware of their specific duties under Regulation 12 of the Human Tissue (Quality & Safety for Human Application) Regulations 2007 (as amended).

The reporting requirements relating to third parties carrying out licensable activities under the terms of a TPA are set out in paragraphs 232-235 of the HTA 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 TPA 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 TPAs.

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.

Records must:

· comply with standard operating procedures (SOPs) for records management. These SOPs should be provided to the third party by the Designated Individual 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 Human Tissue (Quality & Safety for Human Application) Regulations 2007 (as amended)); and

· be retained / maintained in line with reported activities taking place under a TPA 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 and 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 requirements and procedures for reporting adverse events and reactions that occur at third parties should be clearly documented. This may be achieved through the inclusion of detailed information on incident reporting in TPAs, or through the sharing of 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 TPA.

The Designated Individual 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 Designated Individual 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; 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 TPA. The Designated Individual should also ensure the retention of records related to the SAEAR once provided to the HTA, including any follow up reports.