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Proposed licensing framework

Proposed licensing framework. 19 May 2011 Melanie Reid, Regulation Manager. Proposed licensing framework. Why the HTA? What will the licensing framework achieve? Elements of the regulatory framework The licensing framework Ensuring suitable practices under the licence. Why the HTA?.

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Proposed licensing framework

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  1. Proposed licensing framework 19 May 2011 Melanie Reid, Regulation Manager

  2. Proposed licensing framework • Why the HTA? • What will the licensing framework achieve? • Elements of the regulatory framework • The licensing framework • Ensuring suitable practices under the licence

  3. Why the HTA? • Experience of implementing and regulating tissues and cells for human application • Appreciate the organ donation sector’s work as well as the importance of regulation • Want to engage with the sector to ensure the regulatory framework is right touch • Regular meetings with NHSBT • Today’s workshop • Consultation etc...

  4. What will the licensing framework achieve? • Standardises practices across the sector • Minimum licensing standards to be met across all licensed establishments • Standards for quality management, continual improvement, records keeping and traceability etc • Facilitates sharing good practice across establishments • Demonstrated evidence that standardised practices can increase donation rates • Enables early identification of trends • Events and reactions reported to HTA • Information able to be widely shared

  5. What will the licensing framework achieve? • Assurance that activities are carried out appropriately • People/establishments meet licensing standards • Supervised by a “Designated Individual” • Legally enforceable • Increased public and professional confidence in quality and safety of organs • Fewer adverse events and reactions • Decreased risks to quality and safety of organs & recipients • Increased donation • Facilitates exchange across Europe

  6. What elements make up the HTA’s regulatory framework?

  7. The licensing framework

  8. What will be licensed? • Scope = licensed activities • Licensing framework based on activities • NOT living vs. deceased • Quality and safety only – not professional surgical practice

  9. How will activities be licensed? Procurement Organisation Transplant Centre Preservation Donation Characterisation Transplantation Procurement (retrieval) Transport

  10. How are HTA licences governed? • Licence Holder (corporate) • Legal entity • Designated Individual • People • Licensed activities • Fees • Donation • Characterisation • Procurement • Preservation • Transport • Transplantation • Practices

  11. The proposed licensing framework • POs must be licensed for procurement and donation • TCs must be licensed for transplantation • Other activities optional • One establishment can have both licenses • Can be same or different DIs

  12. Why this licensing model? • Separation of governance between procurement and transplantation processes • Flexibility for different establishments • Different DIs can be responsible for different areas if preferred by the establishment

  13. How will NORS teams be licensed? Unlicensed hospital Transplant Centre – NORS employer Testing Procurement Transplantation Characterisation Donation Preservation Transport

  14. Ensuring suitable practices

  15. Ensuring suitable practices under the licence – licensed establishment • Statutory responsibility of the Designated Individual to ensure suitable practices • Direct supervision • Governance/line management • Standard operating procedures • Audit of processes/records • Need to provide satisfactory evidence when applying for a licence

  16. Ensuring suitable practices under the licence – third parties Alternative accreditation Audit SLA/contract

  17. Ensuring suitable practices under the licence - HTA • Assessment of DI suitability prior to licence grant • Desk based inspection of licence application against standards • Assess evidence to ensure standards are met • Ongoing audit of licence

  18. Ensuring suitable practices under the licence - HTA • Not sure how audit will look yet • Likely to involve site visit inspections • Review processes, records and documentation • Interview key staff • Assess establishment against standards • May also involve submission of information • Currently scoping interaction with existing regulators/accreditation bodies e.g. CQC

  19. Key messages • Licensing is an essential part of the regulatory framework – helps provide assurance • Assurance will increase public and professional confidence in organ donation • HTA is working with stakeholders – you! – to ensure the licensing framework is right touch

  20. www.hta.gov.uk

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