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Draft HTA Directions. 19 May 2011 Emyr Harries, Regulation Manager. Aims of this presentation. What are HTA Directions? Content of Directions Questions for discussion Working groups. What are HTA Directions?. HTA have the statutory power to issue Directions Regulatory requirements

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draft hta directions

Draft HTA Directions

19 May 2011

Emyr Harries, Regulation Manager

aims of this presentation
Aims of this presentation
  • What are HTA Directions?
  • Content of Directions
  • Questions for discussion
  • Working groups
what are hta directions
What are HTA Directions?
  • HTA have the statutory power to issue Directions
    • Regulatory requirements
    • Legislation
    • General or Specific
hta directions on organ donation
HTA Directions on Organ Donation
  • Written document stating requirements
  • Created through:
    • Information on existing practices, guidelines/requirements and issues
    • Engagement with NHSBT and DH
    • Engagement with Transplant professionals
    • Engagement with Testing professionals
    • Internal regulatory expertise
characterisation
Characterisation
  • Donor and Organ characterisation
  • Information collection (Annex):
    • minimum data set, complementary data set
  • Risk-benefit analysis
characterisation1
Characterisation
  • Donor and Organ characterisation
  • Information collection (Annex):
    • minimum data set, complementary data set
  • Risk-benefit analysis
  • Is all the information in the Annex being collected? How/when/by whom?
testing
Testing
  • Testing required for organ and donor characterisation
  • Proposing to not license testing centres directly
  • Agreements with laboratories
  • Other accreditation bodies
testing1
Testing
  • Testing required for organ and donor characterisation
  • Proposing to not license testing centres directly
  • Agreements with laboratories
  • Other accreditation bodies
  • What testing would be included?
  • Would the testing activities be covered by other regulatory or accreditation bodies?
preservation
Preservation
  • Chemical agents, alterations in environmental conditions
  • To prevent biological or physical deterioration
  • Procedures for preservation
  • Approved protocol
  • Trained healthcare personnel
preservation1
Preservation
  • Chemical agents, alterations in environmental conditions
  • To prevent biological or physical deterioration
  • Procedures for preservation
  • Approved protocol
  • Trained healthcare personnel
  • How would you ensure the effectiveness of methods and materials used for preservation?
  • How would you validate a new preservation technique/method/material?
transport
Transport
  • Responsible for control of provision of services
  • Operating procedures
  • Agreement with courier
  • Validated organ transport boxes
  • Labelling requirements
transport1
Transport
  • Responsible for control of provision of services
  • Operating procedures
  • Agreement with courier
  • Validated organ transport boxes
  • Labelling requirements
  • How can packaging for transport be validated?
  • Any issues relating to transport of organs?
traceability
Traceability
  • Trace organs from donor to recipient
  • Identification system
  • Storage of data for 30 years after donation
  • European exchange
traceability1
Traceability
  • Trace organs from donor to recipient
  • Identification system
  • Storage of data for 30 years after donation
  • European exchange
  • How standardised are traceability systems currently?
  • How are organs and materials currently traced?
  • Labelling of organs and packaging?
serious adverse events and reactions saears
Serious Adverse Events and Reactions (SAEARs)
  • Serious Adverse Event (SAE)
    • Any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity.
serious adverse events and reactions saears1
Serious Adverse Events and Reactions (SAEARs)
  • Serious Adverse Reaction (SAR)
    • An unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity.
serious adverse events and reactions saears2
Serious Adverse Events and Reactions (SAEARs)
  • Reporting system required
  • Influence the quality and safety of organs
  • SAE - Attributable to the testing, characterisation, procurement, preservation and transport of organs
  • SAR - observed during or after transplantation which may be connected to those activities
  • Current reporting systems, clinical governance, NHSBT
  • EFRETOS (European Framework for the Evaluation of Organ Transplants)
serious adverse events and reactions saears3
Serious Adverse Events and Reactions (SAEARs)
  • SAEARs Working Group – OrganDonationDirective@hta.gov.uk
serious adverse events and reactions saears4
Serious Adverse Events and Reactions (SAEARs)
  • SAEARs Working Group – OrganDonationDirective@hta.gov.uk
  • What current reporting systems are in place for reporting SAEARs at your establishment both internally and externally?
  • What Serious Adverse Events or Reactions have you experienced, or may experience, that you feel would be reportable to the HTA?
workgroup session 60 minutes
Workgroup session (60 minutes)

Focus on:

  • Licensing - Table 1 and Table 2
  • Traceability - Table 3 and Table 4
  • Serious Adverse Events and Reactions - Table 5 and Table 6
  • Characterisation and Testing - Table 7 and Table 8
  • Preservation - Table 9
  • Transport - Table 10
  • Feel free to discuss other areas of the draft Directions as well
  • Facilitator at each table
  • Each table to designate a person to take notes and provide feedback