Third Party Agreements

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Third Party Agreements

• 25 March 2009
• Dr Anthony Noble

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Aims of the presentation

• To inform DIs about
• when Third Party Agreements (TPAs) should be in
  place
• what elements are required in a TPA
• the responsibilities of DIs regarding activities
  covered by TPAs
• reporting TPAs to the HTA

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Third Party Agreements

• Two types
• 1. Licensable activity
• Licensable activity that takes place on
  unlicensed premises on behalf of a licensed
  establishment must be covered by a Third Party
  Agreement (TPA)
• An agreement between two establishments that are
  both licensed by the HTA is referred to as a
  Service Level Agreement
• All activities except storage
• (Paragraph 6, Human Tissue (Quality and Safety
  for Human Application) Regulations 2007)

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Third Party Agreements

• Two types
• 2. Goods or services
• Suppliers of goods and services that may affect
  the quality and safety of tissues and cells
• (Paragraph 6, Human Tissue (Quality and Safety
  for Human Application) Regulations 2007)

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Reporting in Annual Activity Data

• 968 TPAs were reported to the HTA as part of the
  annual activity reports for 08/09
• Almost all for licensable activities (first type)

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A Licence Holder cannot have a Third Party
Agreement with themselves

• Where a corporation or Trust is the Licence
  Holder and the establishment is a single site in
  the corporation or Trust
• Licensable activity is taking place at another
  site also owned by the corporation or Trust
• A satellite licence is required to govern these
  activities as a TPA cannot apply

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Relevant Third Party Premises

• 1. Any premises on which a third party (TP)
  procures, tests, processes, distributes, or to
  which a TP imports, or from which a TP exports,
  tissues and cells on behalf of any person
  authorised by a licence to carry on that activity
• 2. 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

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General requirements

• Who the agreement is between - name, addresses
  etc.
• Terms of the relationship (responsibilities of
  parties)
• Responsibilities of third parties are
  non-delegable
• Technical elements of TPAs must be drawn up by
  suitably qualified and competent persons
• Clearly identify which party is responsible for
  taking consent, donor selection and donor testing
• Have a procedure for complaints including how
  complaints will be handled
• Records related to the activity must meet
  confidentiality requirements
• Provision for the transfer of all records in the
  event of termination
• Provision for the transfer of tissues and cells
  to another licensed establishment in the event of
  termination of activities
• Recall procedure must be put in place
• Serious Adverse Events and Reactions (SAEARs)
  reporting procedure (governed by an SOP) must be
  stipulated
• Provide for communication of any information to
  the licensed establishment, staff working under
  the TPA or any other establishments that may be
  implicated in a SAEAR
• Enable investigations and control measures with
  respect to SAEARs
• Allow access to relevant third party premises for
  the purpose of inspection

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General requirements

• Who the agreement is between - name, addresses
  etc.
• Terms of the relationship (responsibilities of
  parties)
• Responsibilities of third parties are
  non-delegable
• Technical elements of TPAs must be drawn up by
  suitably qualified and competent persons
• Clearly identify which party is responsible for
  taking consent, donor selection and donor testing
• Have a procedure for complaints including how
  complaints will be handled
• Records related to the activity must meet
  confidentiality requirements
• Provision for the transfer of all records in the
  event of termination
• Provision for the transfer of tissues and cells
  to another licensed establishment in the event of
  termination of activities
• Recall procedure must be put in place
• Serious Adverse Events and Reactions (SAEARs)
  reporting procedure (governed by an SOP) must be
  stipulated
• Provide for communication of any information to
  the licensed establishment, staff working under
  the TPA or any other establishments that may be
  implicated in a SAEAR
• Enable investigations and control measures with
  respect to SAEARs
• Allow access to relevant third party premises for
  the purpose of inspection

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General requirements

• Who the agreement is between - name, addresses
  etc.
• Terms of the relationship (responsibilities of
  parties)
• Responsibilities of third parties are
  non-delegable
• Technical elements of TPAs must be drawn up by
  suitably qualified and competent persons
• Clearly identify which party is responsible for
  taking consent, donor selection and donor testing
• Have a procedure for complaints including how
  complaints will be handled
• Records related to the activity must meet
  confidentiality requirements
• Provision for the transfer of all records in the
  event of termination
• Provision for the transfer of tissues and cells
  to another licensed establishment in the event of
  termination of activities
• Recall procedure must be put in place
• Serious Adverse Events and Reactions (SAEARs)
  reporting procedure (governed by an SOP) must be
  stipulated
• Provide for communication of any information to
  the licensed establishment, staff working under
  the TPA or any other establishments that may be
  implicated in a SAEAR
• Enable investigations and control measures with
  respect to SAEARs
• Allow access to relevant third party premises for
  the purpose of inspection

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General requirements

• Who the agreement is between - name, addresses
  etc.
• Terms of the relationship (responsibilities of
  parties)
• Responsibilities of third parties are
  non-delegable
• Technical elements of TPAs must be drawn up by
  suitably qualified and competent persons
• Clearly identify which party is responsible for
  taking consent, donor selection and donor testing
• Have a procedure for complaints including how
  complaints will be handled
• Records related to the activity must meet
  confidentiality requirements
• Provision for the transfer of all records in the
  event of termination
• Provision for the transfer of tissues and cells
  to another licensed establishment in the event of
  termination of activities
• Recall procedure must be put in place
• Serious Adverse Events and Reactions (SAEARs)
  reporting procedure (governed by an SOP) must be
  stipulated
• Provide for communication of any information to
  the licensed establishment, staff working under
  the TPA or any other establishments that may be
  implicated in a SAEAR
• Enable investigations and control measures with
  respect to SAEARs
• Allow access to relevant third party premises for
  the purpose of inspection

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General requirements

• Who the agreement is between - name, addresses
  etc.
• Terms of the relationship (responsibilities of
  parties)
• Responsibilities of third parties are
  non-delegable
• Technical elements of TPAs must be drawn up by
  suitably qualified and competent persons
• Clearly identify which party is responsible for
  taking consent, donor selection and donor testing
• Have a procedure for complaints including how
  complaints will be handled
• Records related to the activity must meet
  confidentiality requirements
• Provision for the transfer of all records in the
  event of termination
• Provision for the transfer of tissues and cells
  to another licensed establishment in the event of
  termination of activities
• Recall procedure must be put in place
• Serious Adverse Events and Reactions (SAEARs)
  reporting procedure (governed by an SOP) must be
  stipulated
• Provide for communication of any information to
  the licensed establishment, staff working under
  the TPA or any other establishments that may be
  implicated in a SAEAR
• Enable investigations and control measures with
  respect to SAEARs
• Allow access to relevant third party premises for
  the purpose of inspection

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Requirements obligations of DI

• To communicate regulatory alerts and HTA
  communications to the TP
• Ensure compliance with HTA Directions (as
  relevant to the activities covered by the TPA)
• Communicate changes to HTA Directions (as
  relevant to the activities covered by the TPA)
• Provide protocols and procedures to be followed
  or provide for the creation of procedures by the
  TP
• Specify criteria that activities must meet

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Requirements TP obligations

• Create, maintain and comply with SOPs as required
• Put in place a document management system that
  ensures full traceability at all stages of
  procurement, processing and distribution
• Ensure that equipment and material are fit for
  purpose
• Ensure that the premises are fit for purpose
• Retain documents procedures and records for
  traceability
• restricted access / disclosure and
  confidentiality
• appoint a named individual to secure this duty
• notwithstanding termination
• consent regarding any disclosure of donor
  information is appropriate
• Put in place a system for reporting SAEARs

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Requirements TP obligations

• Uniquely identify all individual tissue and cell
  specimens
• including the specific information detailed in
  HTA directions - this information must be
  available for the purpose of tracing donors
• Keep a register of the types and amount of
  tissues/cells
• This register must be available on inspection
• This activity must form part of the
  establishments annual activity report
• Put in place an accurate, rapid and verifiable
  recall procedure
• Allow the DI access to premises and facilities to
  assure themselves of fitness for purpose
• To provide relevant regulatory alerts to users of
  tissues and cells as appropriate

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Requirements specific activities

• Processing
• Environmental monitoring and standards
• Required conditions for storage of materials
• Transfer of material following termination of
  activities
• Distribution
• A system for recall and return of tissues and
  cells
• Labelling as required in HTA Directions
• Defined transport conditions
• Validated transport equipment
• Rules governing the assignment of donated tissue
  to recipients

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Requirements specific activities

• Procurement
• Provision that consent is taken in line with HTA
  Directions
• Provision that donor selection criteria meet
  those specified in the EU Tissues and Cells
  Directives
• A system for reporting SAEARs
• A procedure for recall
• Evidence of compliance with SOPs
• Testing
• Provision for how test results will be
  communicated to the establishment

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Requirements specific activities

• Import and export
• Ensure compliance with the HTA Directions and
  code of practice on import and export
• Provide a documented system that allows
  traceability from donor to recipient and vice
  versa
• Ensure that approval is gained from the HTA for
  the import of tissues and cells used directly for
  human application
• Ensure that all tissues and cells imported from
  outside the EEA meet the standards of quality and
  safety as set out in the EUTCD and the Human
  Tissue (Quality and Safety for Human Application)
  Regulations 2007

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Suitability of premises and practices

• SLA with licensed establishment is compliant as
  licensed/inspected by HTA
• The TPA must allow the DI to have access to the
  relevant third party premises. So
• audit of fixed premises
• provision of SOPs and working instructions that
  ensure good practice
• detail standards and technical specifications for
  material that is subject to the TPA
• Where premises are ad hoc such as for procurement
  via a TPA, a defined system for risk assessments
  for new or ad hoc premises can be specified in
  the agreement

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Reporting of Third Party Agreements

• HTA currently requires
• that TPAs are kept by establishments and made
  available on inspection
• reports of activity taking place under TPAs in
  annual activity data
• In future the HTA will require that TPAs are
  registered with the HTA via an online
  registration system (high level information for
  example
• details of who the agreement is with
• what licensable activities are covered by the TPA
• the relevant third party premises related to the
  TPA
• how the DI has assured themselves that these are
  suitable)

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Inspection of Relevant Third Party Premises

• The HTA can inspect Relevant Third Party
  Premises
• risk based inspection process
• fixed premises
• individuals (such as those procuring)
• We will be piloting these inspections in the near
  future

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More information

• More information on Third Party Agreements,
  including Frequently Asked Questions, can be
  found on the HTAs website
• www.hta.gov.uk/tpa-faq

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www.hta.gov.uk