Third Party Agreements by skm10786

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									Third Party Agreements



25 March 2009
Dr Anthony Noble
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
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)
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)
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)
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
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
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
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
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
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
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
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
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
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 establishment’s 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
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
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
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
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
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)
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
More information

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

								
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