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The roles of the Designated Individual and Licence Holder

The roles of the Designated Individual and Licence Holder. 25 March 2009 Dr Christopher Birkett. Aims and outcomes. To help you understand under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) and HTA Directions, the roles of the:

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The roles of the Designated Individual and Licence Holder

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  1. The roles of the Designated Individual and Licence Holder 25 March 2009 Dr Christopher Birkett

  2. Aims and outcomes • To help you understand under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) and HTA Directions, the roles of the: • Designated Individual (DI) • Licence Holder (LH)

  3. UK legislation • The Q&S Regulations transposed the EU Tissues and Cells Directive into UK law • Three sets of HTA Directions detail the standards which establishments must meet

  4. The role of the DI

  5. Statutory duty of the DI It is the duty of the DI (Regulation 12) to secure: • that suitable practices are used in undertaking the licensed activity • that the other persons who work under the licence are suitable • that the conditions of the licence are complied with • that the conditions of Third Party Agreements are complied with, and • that all information relating to licensable activities: • is available for tracing donations • is up to date and correct • is held securely

  6. Broad responsibility of the DI • Ensuring, at each step, the quality and safety of tissues and cells for human application • Premises and facilities • Keeping appropriate records • Reporting annual activity data and SAEARs • Quality management • Suitably trained personnel • Third Party Agreements (TPAs)

  7. Quality and safety of tissues & cells • Must be ensured for each step of the process, including: • reception at the tissue establishment • storage and release • packaging and labelling • distribution and recall • import and export

  8. Premises and facilities • Wide range of licensed premises • The DI must ensure that: • premises and facilities are fit for purpose • SOPs are in place for the management of equipment and materials • risk assessments have been undertaken • environmental monitoring is undertaken

  9. Records: general • The DI must ensure: • data protection and confidentiality • records of donor documentation, traceability and raw data are maintained, audited and securely held

  10. Annual report • The DI must keep a record of the following: • a register of relevant material that falls under the licence, including details of the origin and destination of each sample • a register of the coded data assigned to each donor and donation of tissues and cells • The DI must submit to the HTA an annual report of their activities, to include the information above

  11. Serious Adverse Events and Reactions (SAEARs) • The DI must notify the HTA of any SAEARs immediately and provide a report of the investigations • In the Directions, the DI shares responsibilities with the LH

  12. Quality Management System (QMS) • The DI must implement a system to include: • an appointed quality manager • a quality manual • SOPs required by the Directions • training and reference manuals • any forms • any records required by the HTA • information on the final destination of human tissues and/or cells

  13. Quality Management System (QMS) • The DI must further ensure that: • SOPs are in place for record management and use of QMS • audits and quality reviews are maintained • HTA inspectors adopt a proportionate approach

  14. Personnel • DI must ensure that: • personnel are suitably qualified • there are sufficient staffing levels • staff receive training and CPD • appropriate staff facilities are in place, including protective clothing and equipment

  15. Third party agreements (TPAs) • DI must ensure that: • equipment and materials used by any Third Party are appropriate • Third Parties and their facilities are suitable for the licensable activity • In the Directions, the DI shares responsibilities with the LH

  16. The role of the LH

  17. Role of LH • The LH also has the right to vary a licence • HTA has a preference for the LH to be a corporate body, with a named representative • The LH has a duty to ensure that • the conditions of TPAs are complied with • the Directions are complied with • fees are paid

  18. The role of the LH in practice • Shares responsibilities with the DI for • TPAs • SAEARs • In practical terms, the DI is typically the key person, with a two-way flow of communication occurring between the DI and the corporate body

  19. Summary: the DI • The DI is the lynchpin of regulatory compliance under a licence • How can the HTA help you? • Advice and guidance: website, codes of practice, email and telephone • Face-to-face training and e-learning • Conferences

  20. Questions

  21. www.hta.gov.uk

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