Key duties of LH

1. Key duties of LH • The LH has responsibility for entering into third party agreements. • Ensuring compliance with the traceability requirements. • Ensuring systems in place to investigate, report and record serious adverse event / reactions.

2. Third party agreements

4. Third party agreements • Licensable activities (other than storage) can be carried out under a third party agreement • ‘Third party agreement’ refers to a third party agreement as set out in Directions 002/2007

5. Third party agreements The 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/ies The LH must ensure that: • third party agreements are entered into • A documented system is in place that ensures the identification of the licensable activity/ies • Third parties have systems in place to identify and label tissues and/ or cells

6. Third party agreements Both the DI and the LH must ensure that: • third party agreements are maintained • SOPs are in place and complied with • Information is kept confidential and only disclosed in circumstances permitted by law. • the establishment and third parties responsible retain the minimum donor/ recipient data • third parties establish a recall procedure

7. Licensable activities under the Regulations

8. Procurement • ‘A process by which tissues and cells are made available’. Includes • Consent • Donor Selection & evaluation • Removal of tissues and cells

9. Laboratory tests required for donors

10. Storage • Maintaining tissues and cells, whether by preservation or in any other way, for more than 48 hours.

11. Processing - definition • ‘…all operations involved in the preparation, manipulation, preservation and packaging of tissues and cells intended for human application’.

13. Processing • Normally, where tissues or cells are exposed to the environment an air quality of Grade A with a Grade D background environment required. • Critical processes need to be validated and documented and regularly evaluated.

14. Distribution • ‘…transportation and delivery of tissues and/ or cells intended for human application’ Regulation 5(4)(a) • ‘…a person who, from any premises, controls the provision of services for transporting tissues and cells is taken to distribute tissues and cells on the premises’.

15. Distribution • Critical conditions must be defined and packaging validated as fit for this purpose. • Recall procedures are in place. • Labelling requirements. • Agreements with end users.

16. Import & Export of tissues and cells • From or to a non EEA state or an unlicensed establishment in an EEA state. • Directions 004/2007 set out the standards for import and exports.

17. Serious Adverse Events and Reactions

18. Serious adverse events and reactions notification system

19. Serious adverse events and reactions • DI’s responsibility to ensure SAEs and SARs are reported to the HTA • Establishments need robust reporting procedures, and responsible personnel • SAEs/SARs need to be reported without delay • Reports need to be submitted via the HTA website.

20. Annual Reporting • HTA required to collect data on establishments’ activities • Collected the first set of information • Currently processing data

21. Questions