FORM FRM234/3.1 Effective: DRAFT NCI No._______ NCI Customer Account Application Customer and Institution Information Customer Title, name and position Institution Name Institution Address Customer Department Customer Telephone Customer Fax Customer Email Company Registration No. Existing NHSBT NCI Customer No. (if applicable) Is this application for a new project? Customer Finance Department Information Finance Dept Contact Name Finance Dept Address (if different from institution address) Finance Dept Telephone No. Finance Dept Fax No. Finance Dept Contact Email Project Information Proposed project START Date Proposed project END Date Responsible Persons - please list the persons you want authorised to request products, suspend or amend account details and orders for this account: Name Role within your organisation Email and phone details NHSBT Internal Use EAS £_____________________________________________ Finance approval: Yes / No (please circle) Check performed by:___________________________________________ Signature:___________________________________________________ Date:_________________________ Cross-Referenced in Primary Document: SOP332 Page 1 of 12 FORM FRM234/3.1 Effective: DRAFT NCI No._______ NCI Customer Account Application Components Required - The products/components available from each NHSBT area in the appendices indicated. Please mark next to the area/s from which you are seeking components/materials. In the individual component/product lists in the appendices, please indicate (a) the number of units required and (b) your anticipated order frequency (e.g. daily, weekly, monthly, 6-monthly etc). Your required component list should be returned with this completed application form, a guide to completion of which is available at http://hospital.blood.co.uk/products/nci_of_blood_components/ A. B. C. D. E. F. G. MARK BELOW if you require components BLOOD and BLOOD COMPONENTS CORD BLOOD PATIENT SAMPLES from RED CELL IMMUNOHAEMATOLOGY (“RCI”) CELLULAR AND MOLECULAR THERAPIES THERAPEUTIC APHERESIS SERVICES TISSUES HISTOCOMPATIBILITY AND IMMUNOGENETICS (“H&I”) Further information available at APPENDIX A APPENDIX B APPENDIX C APPENDIX D APPENDIX E APPENDIX F APPENDIX G If you require clinical specification products, H&I material, donor information, specific grouping/serology/virology status or you have a requirement not covered by any of the product descriptions please provide details of your exact requirements below: Operational Requirements – Please answer each of the following Yes No Do you have procedures in place for the safe handling and disposal of supplied materials? Do your processes produce an audit trail covering the receipt, storage, use and fate of all material provided? Do your procedures prevent the passing on of unused or surplus material for any use or to any user not included with this application? Confirm your acceptance that NHSBT may audit as required the systems, processes and individuals employed in the handling, use and disposal of all materials supplied. Do you operate a quality system that is accredited to an internationally recognised standard cGMP, GLP, HTA License, MHRA regulated? NHSBT Internal Use Std / Nonstd / Bespoke Is Ops sign off required: Yes / No (please circle) Ops Review: Approval to supply via NCI: Yes / No (please circle) (If no, please provide details by email. If yes, print, sign, scan & return by email to NCIadmin) Check performed by:___________________________________________ Signature:___________________________________________________ Date:_________________________ Cross-Referenced in Primary Document: SOP332 Page 2 of 12 FORM FRM234/3.1 Effective: DRAFT NCI No._______ NCI Customer Account Application Appropriate Use Please confirm the purpose for which products are required: 1) EQA, IV diagnostics or Laboratory QC 2) Education & Training 3) Service/Product Development 4) Research & Development Yes No Please provide details of the purpose for which material is requested. If the material is going to be used by more than one location, user or samples are to be provided to 3rd parties for quality assurance or analyses please include details. Ethical Approval - information must be provided for all research/development uses Ethical approval status APPLIED FOR If ethical approval is “NOT REQUIRED” please state why: GRANTED HTA License held LREC/NREC reference number Source of funding Will the material be used in any form of genetic research If “YES”, please provide details: NOT REQUIRED YES NO YES NO NHSBT Internal Use Request approved Yes / No (please circle) Consultant/Functional lead Review by:____________________________________ Signature:___________________________________________________ Date:_________________________ Escalated to CARE Yes / No To escalate, complete FRM4623, send to CARE member and nciadmin@nhsbt.nhs.uk Cross-Referenced in Primary Document: SOP332 Page 3 of 12 FORM FRM234/3.1 Effective: DRAFT NCI Customer Account Application NCI No._______ APPENDICES - COMPONENTS AND MATERIALS. The following appendices set out the products and components that can be requested. No charge is made for the donated material itself; NHSBT recovers the costs of issue, retrieval and making components and materials available. Details are provided on receipt of completed application. APPENDIX A: BLOOD and BLOOD COMPONENTS Item Code Product Volume per unit NC01 OTC Serum AB 200ml NC02 OTC Serum non AB 200ml NC04 Cryo depleted plasma 200ml NC05 Plasma 250ml NC07 Buffy Coats 50ml NC08 Buffy Coat residue NC09 Expired platelets NC12 Neonatal expired platelets NC13 Whole blood 485ml approx. NC15 Research red cells 200ml NC16 Expired red cells 200ml NC18 Random Donor samples 1 tube NC20 Research Platelets 1 unit NC22 Random Donor samples 1 deep well micro plate NC23 Leukocyte Filters 1 NC24 Leukocyte Cone 1 NC26 Rare donor sample 1 NC34 Whole blood filter 1 Bulk Discard plasma volumes Min 100 litres per order Clinical Spec Research Red Cells 220–340ml approx. NC50 Cross-Referenced in Primary Document: SOP332 Number of units required Frequency (weekly, monthly etc) Page 4 of 12 FORM FRM234/3.1 NCI Customer Account Application Effective: DRAFT NCI No._______ APPENDIX B: CORD BLOOD Product Number of units required Frequency (weekly, monthly etc) Fresh Cord blood unit Fresh Cord blood unit & Maternal samples Frozen Cord blood unit <2.0x10^6 Total CD34+ve cells Fresh Cord blood unit tissue typing Frozen Cord blood unit >2.0x10^6 Total CD34+ve cells Additional satellite sample from the frozen cord units Placenta & Cord tissue please specify requirements on pg 1 Cross-Referenced in Primary Document: SOP332 Page 5 of 12 FORM FRM234/3.1 NCI Customer Account Application Effective: DRAFT NCI No._______ APPENDIX C: PATIENT SAMPLES from NHSBT RED CELL IMMUNOHAEMATOLOGY (“RCI”) Typically 0.5ml – 5ml of frozen archive samples with the following conditions: Haemolytic Disease of the Newborn and Foetus (HDFN) Sickle Cell disease Thalassaemia Paroxysmal Nocturnal Haemoglobinuria (PNH) Paroxysmal Cold Haemoglobinuria (PCH) Auto Immune Haemolytic Anaemia (AIHA) Cold Haemolytic Disease (CHAD) IgA deficiency Determination of Feto-Maternal Haemorrhage (FMH) Drug associated AIHA Ante natal samples For all of the above please note that: RCI are unable to detail volumes, specificities or strength (titre/quantification value) of each type in advance but will confirm details and availability on application. Samples can only be released when minimum RCI retention period has expired. So RCI cannot assure the availability of any sample. May have been initially sampled & tested in RCI laboratories. Please use the following table to indicate to request samples from RCI: Volume of sample required ml Condition Cross-Referenced in Primary Document: SOP332 Number of samples required Frequency (weekly, monthly etc) Page 6 of 12 FORM FRM234/3.1 Effective: DRAFT NCI No._______ NCI Customer Account Application APPENDIX D: CELLULAR AND MOLECULAR THERAPY PRODUCTS Product Volume per unit HPC-A (Haemopoietic progenitor cells - Apheresis) 100ml HPC-BM (Haemopoietic progenitor cells - Bone Marrow) 100ml HPC-C (Haemopoietic progenitor cells - Cord Blood) 100ml TC-T (Therapeutic Cells -T cells) 100ml Number of units required Frequency (weekly, monthly etc) NOTE: All materials are supplied cryo preserved Cross-Referenced in Primary Document: SOP332 Page 7 of 12 FORM FRM234/3.1 Effective: DRAFT NCI No._______ NCI Customer Account Application APPENDIX E: THERAPEUTIC APHERESIS Product Volume per unit Plasma: residual from single patient plasmapheresis 2 litres approx. Used CD34 therapeutic Harness. Single patient 1 Red cells, residual from single patient exchange 2 litres+ White cells – residual from single patient exchange 2 litres Harness & Column: single patient low density lipids 1 Harness: residual blood following from ECP procedures 1 Platelets: residual material from Platelet depletion procedure, single patient NOTE: There is usually less than 1 unit a year available 2 litres approx. Cross-Referenced in Primary Document: SOP332 Number of units required Frequency (weekly, monthly etc) Page 8 of 12 FORM FRM234/3.1 Effective: DRAFT NCI No._______ NCI Customer Account Application APPENDIX F: TISSUE SERVICES Tendons are supplied either decontaminated or irradiated. Please specify at time of ordering. Item Code Product Volume per unit TP2003 Dried washed irradiated cancellous cubes TP2005 Dried washed irradiated cancellous chips TP2006 Dried washed irradiated tricortical wedge 10x10x10mm (Pack 5) 6x6x30mm (Pack 5) 30x15mm TP2007 Washed irradiated humeral shaft 1 TP2008 Frozen washed irradiated humeral head 1 TP2011 Frozen washed irradiated cortical strut Small 15cm TP2012 Frozen washed irradiated cortical strut Medium 19cm TP2013 Frozen washed irradiated cortical strut Large 24cm TP2014 Freeze-dried washed irradiated cortical strut Small 15cm TP2015 Freeze-dried washed irradiated cortical strut Medium 19cm TP2016 Freeze-dried washed irradiated cortical strut Large 24cm TP1001 Fresh frozen femoral head Minimum 50g TP1002 Fresh frozen femoral heads Small TP1003 Irradiated fresh frozen femoral head Minimum 50g TP1004 Washed irradiated femoral head Whole TP1005 Frozen washed irradiated femoral head Half TP1006 Freeze-dried washed irradiated femoral head Whole TP1007 Freeze-dried washed irradiated femoral head Half TP1008 Freeze-dried washed irradiated femoral head Slice TP3001 Irradiated ground cancellous/cortical mix 35cc TP3002 Freeze-dried irradiated ground cancellous/cortical mix Freeze-dried washed irradiated cancellous/cortical - coarse Freeze-dried washed irradiated cancellous/cortical - coarse Dried washed irradiated cancellous/cortical medium Freeze - dried washed irradiated cancellous/cortical - medium Dried washed irradiated cancellous/cortical -– fine Dried washed irradiated cancellous/cortical -– fine Osteochondral cryopreserved whole patella 70cc Osteochondral cryopreserved femoral condyle left lateral 1 TP3003 TP3004 TP3005 TP3006 TP3007 TP3008 TP4001 TP4008 Cross-Referenced in Primary Document: SOP332 Number of units required Frequency (weekly, monthly etc) 15cc 35cc 15cc 35cc 15cc 35cc 11 Page 9 of 12 FORM FRM234/3.1 Effective: DRAFT NCI No._______ NCI Customer Account Application Item Code Product Volume per unit TP4009 1 TP5009 Osteochondral cryopreserved femoral condyle right lateral Osteochondral cryopreserved proximal tibia left lateral Osteochondral cryopreserved proximal tibia right lateral Osteochondral cryopreserved femoral condyle left medial Osteochondral cryopreserved femoral condyle right medial Osteochondral cryopreserved proximal tibia left medial Osteochondral cryopreserved proximal tibia right medial Putty TP5010 Putty 5cc TP5011 Putty 10cc TP5012 Paste 1cc TP5013 Paste 5cc TP5014 Paste 10cc TP5015 Powder 10cc TP2010 Washed irradiated hemi-pelvis 1 TP4002 Frozen washed irradiated proximal femur right 1 TP4003 Frozen washed irradiated proximal femur left 1 TP4004 Frozen washed irradiated distal femur left 1 TP4005 Washed irradiated distal femur right 1 TP4006 Washed irradiated proximal tibia left 1 TP4007 Frozen washed irradiated proximal tibia right 1 TP4019 1 TP4020 Frozen washed irradiated proximal humerus left Frozen washed irradiated proximal humerus TP7001 Cryopreserved aortic valve 1 TP7002 Cryopreserved pulmonary valve 1 TP7003 Cryopreserved non-valved aortic conduit 1 TP7004 Cryopreserved non-valved pulmonary conduit 1 TP7005 Cryopreserved superfacial femoral artery Per cm TP7006 Pericardium Patch small TP7007 Pericardium Patch medium TP7008 Pericardium Patch large TP7010 Cryopreserved Pericardium 1 TPAdmin Heart admin fee 1 TP4010 TP4011 TP4012 TP4013 TP4014 TP4015 Cross-Referenced in Primary Document: SOP332 Number of units required Frequency (weekly, monthly etc) 1 1 1 1 1 1 1cc 1 Page 10 of 12 FORM FRM234/3.1 Effective: DRAFT NCI No._______ NCI Customer Account Application Item Code Product Volume per unit TP6001 Frozen whole achilles with bone block >16cm TP6002 Frozen whole patella tendon – with bone block 1 TP6003 1 TP6004 Frozen whole patella tendon – with preshaped bone block Frozen whole semitendinosus long TP6005 Frozen whole semitendinosus medium 20-27cm TP6006 Frozen whole semitendinosus short <20cm TP6015 Frozen whole extensor mechanism - custom 1 TP6019 Frozen whole achilles with bone clock <16cm TP6020 Frozen whole tibialis anterior long >35cm TP6021 Frozen whole tibialis anterior medium 30-35cm TP6022 Frozen whole tibialis anterior short <30cm TP601618 Meniscus is available either right or left and in a range of sizes. Please contact Customer Care. TP6016 Cryopreserved meniscus whole Tendons are supplied either decontaminated or irradiated. Please specify at time of ordering. 1 TP6017 Cryopreserved meniscus medial 1 TP6018 Cryopreserved meniscus lateral 1 TP9001 Frozen amniotic membrane 2x2cm TP9002 Frozen amniotic membrane 3x3cm TP9003 Amniotic membrane 5x5cm TP8006 dCELL Dermis® Human dermis small 3x3cm TP8007 dCELL Dermis® Human dermis medium 5x5cm TP8008 dCELL Dermis® Human dermis large 5x10cm TP8001 Crypreserved split skin large pack Minimum 330 CM2 TP8003 Irradiated split skin large pack Minimum 330 CM2 Number of units required Frequency (weekly, monthly etc) >27cm Cost recovery will include next day delivery by 1pm for tissue products Cross-Referenced in Primary Document: SOP332 Page 11 of 12 FORM FRM234/3.1 NCI Customer Account Application Effective: DRAFT NCI No._______ APPENDIX G: HISTOCOMPATIBILITY AND IMMUNOGENETICS (“H&I”) Typically, H&I offer Sera to EQA schemes with the following: HLA HPA HNA Ab +ve and –ve If you have a requirement for this material type for an EQA scheme or NHSBT use, please use the free text box on PAGE 2 to detail your exact requirements for H&I material. Cross-Referenced in Primary Document: SOP332 Page 12 of 12