1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. Annual activity report 2014 word-based data collection form We recommend you gather data in advance by sharing this form with your colleagues. Please note you are not able to send this form instead of submitting data via the web Portal. Your details Name of licensed establishment Your five-digit licensing number Name of person completing this submission Your email address Your daytime telephone number Financial information Who should we contact regarding payment of licensing fees to the HTA? What is the address of your finance department? Contact name: Contact email: Postcode: Licensable activities We will use this information to calculate your licence fee, so ensure you only tick the boxes for the activities that you need to be licensed for, and undertake either at your establishment, at your satellite site(s) or under the authority of your licence through a Third Party Agreement. If these activities change at any time you must notify the HTA, otherwise you risk breaching the Quality and Safety Regulations 2007 or being charged the wrong fee. Licensable activities (please select boxes). Please note that these are the activities shown on your licence. Procurement Donor testing Processing Distribution Export Import Storage How many satellites are associated with your main licence? How many donors were tested under the authority of your licence between 1 January and 31 December 2014? Do you store tissue for a scheduled purpose (such as research) under the authority of a HTA licence issued under the Human Tissue Act 2004? Please note you will not be charged for this licensable activity in 2014/15. Yes No 2 Tissue types Please verify the types of tissues and cells you worked with between 1 January 2014 and 31 December 2014. You will only be able to enter data relating to the tissue types that you select here. Skeletal tissues (please select) Bone Tendons/ligaments Cartilage and/or chondral tissue Demineralized bone Acellular bone chips Other skeletal tissues Blood cells and stem cells (please select) Peripheral Blood Stem Cells Bone marrow Cells for Donor Lymphocyte Infusions Umbilical cord blood Umbilical cord tissue Human embryonic stem cells (hESCs) Other blood cells Ocular tissues (please select) Cornea Sclera Limbal Stem Cells Other ocular tissues Vascular tissues (please select) Heart valves Iliac vessels Other vessels Skin (please select) Whole skin and/or Keratinocyte cells Fibroblast Other tissues or cells (please select) Pancreatic islets Hepatocytes Amniotic membrane Adipose tissue (e.g. adipocytes) Ovarian and testicular tissues Other tissues or cells Additional questions Have any tissues or cells been used in your establishment as starting materials for ATMPs or IMPs? Yes No Have you derived any cell lines (hESCs or any other type) from tissues in 2014 for human application? Yes No 3 Data entry for skeletal tissues Using the information gathered in your tissue register for the period of 1 January to 31 December 2014, enter the number of units of each tissue type associated with each activity. Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Used in a transplant/engraftment within your establishment Bone Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Tendons and ligaments Used in a transplant/engraftment within your establishment Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as 4 Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into your establishment Distributed to you from another establishment from within the UK or EEA Procured under your licence from a donor Processing within your establishment Cartilage and chondral tissue How many units were processed within your establishment? How many units were held following processing? (Not including units which weren’t processed) Used in a transplant/engraftment within your establishment Output from your establishment Distributed to another establishment within the UK or EEA Exported to outside the EEA Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Tissue type Storage within your establishment We calculate your net change of units in 2014 as Descriptor Licensable activity We calculate the number of units stored at your establishment on 31 December 2014 as Number of units Imported from outside the EEA Input into your establishment Distributed to you from another establishment from within the UK or EEA Number of processed units from bone which was procured under your licence from a donor Used in a transplant/engraftment within your establishment Demineralized bone Output from your establishment Distributed to another establishment within the UK or EEA Exported to outside the EEA Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage within your establishment We calculate your net change of units in 2014 as We calculate the number of units stored at your establishment on 31 December 2014 as 5 Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into your establishment Distributed to you from another establishment from within the UK or EEA Number of processed units from bone which was procured under your licence from a donor Used in a transplant/engraftment within your establishment Acellular bone chips Output from your establishment Distributed to another establishment within the UK or EEA Exported to outside the EEA Disposed of Used as starting material for an IMP or ATMP Storage within your establishment Please enter the number of units stored on 1 January 2014 We calculate your net change of units in 2014 as We calculate the number of units stored at your establishment on 31 December 2014 as Tissue type Please describe other skeletal tissues referred to here and record all together when asked: Descriptor Licensable activity Number of units Imported from outside the EEA Input into your establishment Distributed to you from another establishment from within the UK or EEA Number of processed units from bone which was procured under your licence from a donor Used in a transplant/engraftment within your establishment Other skeletal tissues Output from your establishment Distributed to another establishment within the UK or EEA Exported to outside the EEA Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage within your establishment We calculate your net change of units in 2014 as We calculate the number of units stored at your establishment on 31 December 2014 as 6 Data entry for blood cells and stem cells Using the information gathered in your tissue register for the period of 1 January to 31 December 2014, enter the number of units of each tissue type associated with each activity. Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Used in a transplant/engraftment within your establishment Periphera l Blood Stem Cells (PBSCs) Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as How many procurements were for autologous use only? How many procurements were for allogeneic use through a Procurements registry? How many allogeneic procurements were for directed or related recipients? Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor Bone marrow (BM) How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Used in a transplant/engraftment within your establishment Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Storage Please enter the number of units stored on 1 January 2014 within your establishment We calculate your net change of units in 2014 as 7 We calculate the number of units stored at your establishment on 31 December 2014 as How many procurements were for autologous use only? How many procurements were for allogeneic use through a Procurements registry? How many allogeneic procurements were for directed or related recipients? Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Used in a transplant/engraftment within your establishment Donor Lymphoc yte Infusions (DLI) Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as How many procurements were for autologous use only? How many procurements were for allogeneic use through a Procurements registry? How many allogeneic procurements were for directed or related recipients? Tissue type Umbilical cord blood PLEASE REPORT UMBILICAL CORD BLOOD TISSUE SEPARAT ELY Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Used in a transplant/engraftment within your establishment Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP 8 Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as How many procurements were for autologous use only? How many procurements were for allogeneic use through a Procurements registry? How many allogeneic procurements were for directed or related recipients? Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor Umbilical cord blood tissue PLEASE REPORT UMBILICAL CORD BLOOD SEPARAT ELY How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Used in a transplant/engraftment within your establishment Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as Please note, one ‘unit’ equates to one container of cells, regardless of size or the number of cells contained. Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Embryoni c stem cells (hESCs) ONLY REPORT ACTIVITY RELATED TO HUMAN APPLICATI ON Input into Distributed to you from another establishment from within the UK your or EEA establishment How many units were stored following derivation by your establishment? Distributed to other establishments within the UK or EEA Output from Exported to outside the EEA your establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as 9 Please describe other blood cells referred to here: Tissue type 21. Descriptor 22. Licensable activity 23. Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor Other blood cells Record all together when asked How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Used in a transplant/engraftment within your establishment Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as 10 Data entry for ocular tissues Using the information gathered in your tissue register for the period of 1 January to 31 December 2014, enter the number of units of each tissue type associated with each activity. Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor Corneas PLEASE REPORT LIMBAL STEM CELLS SEPARAT ELY How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Used in a transplant/engraftment within your establishment Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as Tissue type Descriptor Licensable activity Input into your establishment Imported from outside the EEA Number of units Distributed to you from another establishment from within the UK or EEA Procured under your licence from a donor Processing within your establishment Sclera How many units were processed within your establishment? How many units were held following processing? (Not including units which weren’t processed) Used in a transplant/engraftment within your establishment Output from your establishment Distributed to another establishment within the UK or EEA Exported to outside the EEA Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage within your establishment We calculate your net change of units in 2014 as We calculate the number of units stored at your establishment on 31 December 2014 as 11 Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor Limbal Stem Cells (LSCs) PLEASE REPORT CORNEAS SEPARAT ELY How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Used in a transplant/engraftment within your establishment Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as Please describe other ocular tissues referred to here: Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor Other ocular tissues Record all together when asked How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Used in a transplant/engraftment within your establishment Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as 12 Data entry for vascular tissues Using the information gathered in your tissue register for the period of 1 January to 31 December 2014, enter the number of units of each tissue type associated with each activity. Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into your establishment Distributed to you from another establishment from within the UK or EEA Procured under your licence from a donor Processing within your establishment How many units were processed within your establishment? How many units were held following processing? (Not including units which weren’t processed) Used in a transplant/engraftment within your establishment Heart valves Output from your establishment Distributed to another establishment within the UK or EEA Exported to outside the EEA Disposed of Used as starting material for an IMP or ATMP Storage within your establishment Tissue type Descriptor Please enter the number of units stored on 1 January 2014 We calculate your net change of units in 2014 as We calculate the number of units stored at your establishment on 31 December 2014 as Licensable activity Number of units Imported from outside the EEA Input into your establishment Distributed to you from another establishment from within the UK or EEA Procured under your licence from a donor Processing within your establishment How many units were processed within your establishment? How many units were held following processing? (Not including units which weren’t processed) Used in a transplant/engraftment within your establishment Iliac Vessels Output from your establishment Distributed to another establishment within the UK or EEA Exported to outside the EEA Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage within your establishment We calculate your net change of units in 2014 as We calculate the number of units stored at your establishment on 31 December 2014 as 13 Please describe other vessels referred to here: Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within the UK your or EEA establishment Procured under your licence from a donor Other vessels How many units were processed within your establishment? Processing within your How many units were held following processing? (Not including establishment units which weren’t processed) Used in a transplant/engraftment within your establishment Record all data together when asked Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as 14 Data entry for skin Using the information gathered in your tissue register for the period of 1 January to 31 December 2014, enter the number of units of each tissue type associated with each activity. Tissue Number of Descriptor Licensable activity type units Whole skin PLEASE PROVIDE DATA RELATING TO NUMBER OF UNITS, REGARDLE SS OF THE SIZE OF THE INDIVIDUAL UNITS Tissue type Fibroblast and/or keratinocy te cells ONLY REPORT ACTIVITY RELATED TO HUMAN APPLICATI ON. EXCLUDE ACTIVITY RELATED TO RESEARCH CELLS. Input into your establishme nt Imported from outside the EEA Processing within your establishme nt How many units were processed within your establishment? Distributed to you from another establishment from within the UK or EEA Procured under your licence from a donor How many units were held following processing? (Not including units which weren’t processed) Used in a transplant/engraftment within your establishment Output from your establishme nt Distributed to another establishment within the UK or EEA Exported to outside the EEA Disposed of Used as starting material for an IMP or ATMP Storage within your establishme nt Please enter the number of units stored on 1 January 2014 Descriptor Licensable activity Input into your establishme nt Imported from outside the EEA Processing within your establishme nt How many units were processed within your establishment? We calculate your net change of units in 2014 as We calculate the number of units stored at your establishment on 31 December 2014 as Number of units Distributed to you from another establishment from within the UK or EEA Derived from within your establishment How many units were held following processing? (Not including units which weren’t processed) Used in a transplant/engraftment within your establishment Output from your establishme nt Distributed to another establishment within the UK or EEA Exported to outside the EEA Disposed of Used as starting material for an IMP or ATMP Storage within your establishme nt Please enter the number of units stored on 1 January 2014 We calculate your net change of units in 2014 as We calculate the number of units stored at your establishment on 31 December 2014 as 15 Data entry for other tissues or cells Using the information gathered in your tissue register for the period of 1 January to 31 December 2014, enter the number of units of each tissue type associated with each activity. Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into your establishment Distributed to you from another establishment from within the UK or EEA Procured under your licence from a donor Processing within your establishment Pancreatic Islets How many units were processed within your establishment? How many units were held following processing? (Not including units which weren’t processed) Used in a transplant/engraftment within your establishment Output from your establishment Distributed to another establishment within the UK or EEA Exported to outside the EEA Disposed of Used as starting material for an IMP or ATMP Storage within your establishment Tissue type Descriptor Please enter the number of units stored on 1 January 2014 We calculate your net change of units in 2014 as We calculate the number of units stored at your establishment on 31 December 2014 as Licensable activity Number of units Imported from outside the EEA Input into your establishment Distributed to you from another establishment from within the UK or EEA Procured under your licence from a donor Processing within your establishment How many units were processed within your establishment? How many units were held following processing? (Not including units which weren’t processed) Used in a transplant/engraftment within your establishment Hepatocytes Output from your establishment Distributed to another establishment within the UK or EEA Exported to outside the EEA Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage within your establishment We calculate your net change of units in 2014 as We calculate the number of units stored at your establishment on 31 December 2014 as 16 Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within your the UK or EEA establishment Procured under your licence from a donor How many units were processed within your establishment? Processing within your How many units were held following processing? (Not establishment including units which weren’t processed) Used in a transplant/engraftment within your establishment Amniotic membrane Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within your the UK or EEA establishment Procured under your licence from a donor Adipose Tissue (e.g. adipocytes) How many units were processed within your establishment? Processing within your How many units were held following processing? (Not establishment including units which weren’t processed) Used in a transplant/engraftment within your establishment Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as 17 Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within your the UK or EEA establishment Procured under your licence from a donor Ovarian and testicular tissues Record all together when asked How many units were processed within your establishment? Processing within your How many units were held following processing? (Not establishment including units which weren’t processed) Used in a transplant/engraftment within your establishment Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as Please describe all other tissues or cells you procured, tested, stored, distributed, imported or exported in 2014: Tissue type Descriptor Licensable activity Number of units Imported from outside the EEA Input into Distributed to you from another establishment from within your the UK or EEA establishment Procured under your licence from a donor All other tissues or cells Record all together when asked How many units were processed within your establishment? Processing within your How many units were held following processing? (Not establishment including units which weren’t processed) Used in a transplant/engraftment within your establishment Distributed to another establishment within the UK or EEA Output from your Exported to outside the EEA establishment Disposed of Used as starting material for an IMP or ATMP Please enter the number of units stored on 1 January 2014 Storage We calculate your net change of units in 2014 as within your establishment We calculate the number of units stored at your establishment on 31 December 2014 as 18 Further information Please use the space below to provide any further information. For example, if any error messages have been given, please explain why you think the data you inputted is accurate. Also, if the end-of-year stock calculation does not tally with your stock check, please make this clear, with an explanation or the difference. Feedback Please provide some feedback relating to the annual activity data submission process for 2014. How clear were the instructions and communications from the HTA prior to submitting the 2014 data? Very clear Partially clear Not clear How do you rate the online submission process this year in comparison to previous years? Better The same Worse Not applicable (e.g. this is the first submission you have made) How useful did you find the guidance document for this year’s submission? Very useful Partially useful Not useful I did not read it Please provide any further comments on how you feel we could improve our data collection process for future years in the space below. Declaration I have completed this annual activity data submission using the information recorded in my establishment’s tissue register during 2014. I certify that the information provided is accurate. I agree with this declaration Please note that once you have submitted this data it cannot be recalled. If you wish to correct your data entry please do so before you submit this form. 19