Draft HTA Directions

1. Draft HTA Directions 19 May 2011 Emyr Harries, Regulation Manager

2. Aims of this presentation • What are HTA Directions? • Content of Directions • Questions for discussion • Working groups

3. What are HTA Directions? • HTA have the statutory power to issue Directions • Regulatory requirements • Legislation • General or Specific

4. 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

5. HTA Directions on Organ Donation

6. HTA Directions on Organ Donation

7. Characterisation • Donor and Organ characterisation • Information collection (Annex): • minimum data set, complementary data set • Risk-benefit analysis

8. 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?

9. Testing • Testing required for organ and donor characterisation • Proposing to not license testing centres directly • Agreements with laboratories • Other accreditation bodies

10. 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?

11. Preservation • Chemical agents, alterations in environmental conditions • To prevent biological or physical deterioration • Procedures for preservation • Approved protocol • Trained healthcare personnel

12. 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?

13. Transport • Responsible for control of provision of services • Operating procedures • Agreement with courier • Validated organ transport boxes • Labelling requirements

14. 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?

15. Traceability • Trace organs from donor to recipient • Identification system • Storage of data for 30 years after donation • European exchange

16. 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?

17. 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.

18. 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.

19. 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)

20. Serious Adverse Events and Reactions (SAEARs) • SAEARs Working Group – OrganDonationDirective@hta.gov.uk

21. 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?

22. 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

23. www.hta.gov.uk