FORM FRM234/3 Effective: 02/10/14 NCI Customer Account Application CUSTOMER AND INSTITUTION INFORMATION Customer Title, name and position) Institution Name Institution Address No.______ Customer Department Customer Telephone Customer Fax Customer Email Company Registration Number. Existing NHSBT NCI Customer No. (if applicable) 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 Check performed by:Name_____________________ Date:_________________________ (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 1 of 12 FORM FRM234/3 Effective: 02/10/14 NCI Customer Account Application COMPONENTS REQUIRED - The products/components available from each NHSBT area in the appendices indicated. Please put a tick in this list next to the area/s from which you are seeking components/materials. No.______ TICK BELOW if you require components Further information available at In the individual component/product lists in the appendices, please indicate (a) the number of units required and (b) your anticipated order frequency (eg 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. 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”) 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 in place procedures 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 Y/N Ops Review : Approval to supply via NCI Y/N Name: (if no please provide details by email if Yes print, sign, scan & return by email to NCIadmin ) Signature_______________________________________________Date (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 2 of 12 FORM FRM234/3 Effective: 02/10/14 NCI Customer Account Application No.______ Appropriate Use Please confirm the purpose for which products are being requested by circling the appropriate answer: 1) EQA, IV diagnostics or Laboratory QC YES / NO 2) Education & Training YES / NO 3) Service/Product Development YES / NO 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 / GRANTED / NOT REQUIRED If ethical approval is “NOT REQUIRED” please state why below: HTA License held Y/N LREC/NREC reference number Source of funding Will the material be used in any form of genetic research If “YES”, please provide details below NHSBT Internal Use YES / NO Consultant/Functional lead Review by Request approved Y/N signature_________________________________ Date: Escalated to CARE Y/N To escalate, complete FRM4623, send to CARE member and NCIadmin@nhsbt.nhs.uk (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 3 of 12 FORM FRM234/3 Effective: 02/10/14 NCI Customer Account Application 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 Units required Frequency weekly, monthly… (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 4 of 12 FORM FRM234/3 NCI Customer Account Application Effective: 02/10/14 No.______ APPENDIX B: CORD BLOOD Product No. 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 (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 5 of 12 FORM FRM234/3 Effective: 02/10/14 NCI Customer Account Application 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 Number of samples required Frequency ie Weekly/ Monthly (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 6 of 12 FORM FRM234/3 Effective: 02/10/14 NCI Customer Account Application No.______ APPENDIX D: CELLULAR AND MOLECULAR THERAPY PRODUCTS Product Volume HPC-A (Haemopoietic progenitor cells - Apheresis) 100 ml HPC-BM (Haemopoietic progenitor cells - Bone Marrow) 100 ml HPC-C (Haemopoietic progenitor cells - Cord Blood) 100 ml HPC-C (Haemopoietic progenitor cells - Cord Blood) 100 ml TC-T (Therapeutic Cells -T cells) 100 ml No. of units required Frequency ie weekly, monthly NOTE: All materials are supplied cryo preserved (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 7 of 12 FORM FRM234/3 Effective: 02/10/14 NCI Customer Account Application No.______ APPENDIX E: THERAPEUTIC APHERESIS Product Plasma: residual from single patient plasmapheresis Volume per No. of units unit required Approx. 2 litres Used CD34 therapeutic Harness. Single patient 1 red cells, residual from single patient exchange 2litres+ 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. Frequency (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 8 of 12 FORM FRM234/3 Effective: 02/10/14 NCI Customer Account Application No.______ APPENDIX F: TISSUE SERVICES Tendons are supplied either decontaminated or irradiated. Please specify at time of ordering. Item Code Product Volume per unit TP2003 10X10X10MM (PACK 5) 6X6X30MM (PACK 5) 30X15MM TP1001 DRIED WASHED IRRADIATED CANCELLOUS CUBESDRIED WASHED IRRADIATED CANCELLOUS CHIPS DRIED WASHED IRRADIATED TRICORTICAL WEDGE WASHED IRRADIATED HUMERAL SHAFT FROZEN WASHED IRRADIATED HUMERAL HEAD FROZEN WASHED IRRADIATED CORTICAL STRUT FROZEN WASHED IRRADIATED CORTICAL STRUT FROZEN WASHED IRRADIATED CORTICAL STRUT FREEZE-DRIED WASHED IRRADIATED CORTICAL Strut -DRIED WASHED IRRADIATED CORTICAL STRUT FREEZE-DRIED WASHED IRRADIATED CORTICAL STRUT FRESH FROZEN FEMORAL HEAD TP1002 FRESH FROZEN FEMORAL HEADS SMALL TP1003 IRRADIATED FRESH FROZEN FEMORAL HEAD WASHED IRRADIATED FEMORAL HEAD MINIMUM 50G FROZEN WASHED IRRADIATED FEMORAL HEAD FREEZE-DRIED WASHED IRRADIATED FEMORAL HEAD FREEZE-DRIED WASHED IRRADIATED FEMORAL HEAD FREEZE-DRIED WASHED IRRADIATED FEMORAL HEAD IRRADIATED GROUND CANCELLOUS/CORTICAL MIX FROZEN IRRADIATED GROUND CANCELLOUS/CORTICAL MIX FREEZE DRIED WASHED IRRADIATED CANCELLOUS/CORTICAL-COARSE FREEZE DRIED WASHED IRRADIATED CANCELLOUS/CORTICAL-COARSE HALF TP2005 TP2006 TP2007 TP2008 TP2011 TP2012 TP2013 TP2014 TP2015 TP2016 TP1004 TP1005 TP1006 TP1007 TP1008 TP3001 TP3002 TP3003 TP3004 Units required Frequency single, weekly, monthly 1 1 SMALL 15CM MEDIUM 19CM LARGE 24CM SMALL 15CM MEDIUM 19CM LARGE 24CM MINIMUM 50G WHOLE WHOLE HALF slice 35CC 70CC 15CC 35CC (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 9 of 12 FORM FRM234/3 Effective: 02/10/14 NCI Customer Account Application TP3005 No.______ 15CC TP5009 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 OSTEOCHONDRAL CRYOPRESERVED FEMORAL CONDYLE LEFT LATERAL OSTEOCHONDRAL CRYOPRESERVED FEMORAL CONDYLE RIGHT LATERAL OSTEOCHONDRAL CRYOPRESERVED PROXIMAL TIBIA LEFT LATERAL OSTEOCHONDRAL CRYOPRESERVED PROXIMAL TIBIA RIGHT LATERAL OSTEOCHONDRAL CRYOPRESERVED FEMORAL CONDYLE LEFT MEDIAL 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 FROZEN WASHED IRRADIATED PROXIMAL FEMUR LEFT FROZEN WASHED IRRADIATED DISTAL FEMUR LEFT WASHED IRRADIATED DISTAL FEMUR RIGHT WASHED IRRADIATED PROXIMAL TIBIA LEFT FROZEN WASHED IRRADIATED PROXIMAL TIBIA RIGHT FROZEN WASHED IRRADIATED PROXIMAL HUMERUS LEFT 1 TP3006 TP3007 TP3008 TP4001 TP4008 TP4009 TP4010 TP4011 TP4012 TP4013 TP4014 TP4015 TP4003 TP4004 TP4005 TP4006 TP4007 TP4019 35CC 15CC 35CC 11 1 1 1 1 1 1 1 1 1CC 1 1 1 1 1 1 (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 10 of 12 FORM FRM234/3 Effective: 02/10/14 NCI Customer Account Application TP4020 No.______ FROZEN WASHED IRRADIATED PROXIMAL HUMERUS CRYOPRESERVED AORTIC VALVE 1 1 TP7006 CRYOPRESERVED PULMONARY VALVE CRYOPRESERVED NON-VALVED AORTIC CONDUIT CRYOPRESERVED NON-VALVED PULMONARY CONDUIT CRYOPRESERVED SUPERFICIAL FEMORAL ARTERY PERICARDIUM TP7007 PERICARDIUM PATCH MEDIUM TP7008 PERICARDIUM PATCH large TP7010 CRYOPRESERVED PERICARDIUM 1 TP7001 TP7002 TP7003 TP7004 TP7005 1 1 1 PER CM PATCH SMALL TPAdmin HEART ADMIN FEE 1 TP6001 FROZEN WHOLE ACHILLES WITH BONE BLOCK FROZEN WHOLE PATELLA TENDON WITH BONE BLOCK FROZEN WHOLE PATELLA TENDON WITH PRE-SHAPED BONE BLOCK FROZEN WHOLE SEMITENDINOSUS LONG FROZEN WHOLE SEMITENDINOSUS MEDIUM FROZEN WHOLE SEMITENDINOSUS SHORT FROZEN WHOLE EXTENSOR MECHANISM - CUSTOM FROZEN WHOLE ACHILLES WITH BONE BLOCK FROZEN WHOLE TIBIALIS ANTERIOR LONG FROZEN WHOLE TIBIALIS ANTERIOR MEDIUM FROZEN WHOLE TIBIALIS ANTERIOR SHORT Meniscus is available either right or left and in a range of sizes. Please contact Customer Care >16CM TP6016 CRYOPRESERVED MENISCUS WHOLE 1 TP6017 CRYOPRESERVED MENISCUS MEDIAL 1 TP6018 CRYOPRESERVED MENISCUS LATERAL 1 TP6002 TP6003 TP6004 TP6005 TP6006 TP6015 TP6019 TP6020 TP6021 TP6022 TP601618 1 1 >27CM 20-27CM <20CM 1 <16CM >35CM 30-35CM <30CM Tendons are supplied either decontaminated or irradiated. Please specify at time of ordering. (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 11 of 12 FORM FRM234/3 Effective: 02/10/14 NCI Customer Account Application No.______ TP9001 FROZEN AMNIOTIC MEMBRANE 2X2CM TP9002 FROZEN AMNIOTIC MEMBRANE 3X3CM TP9003 AMNIOTIC MEMBRANE 5X5CM TP8006 dCELL Dermis® HUMAN DERMIS SMALL 3CM X 3CM TP8007 dCELL Dermis® HUMAN DERMIS MEDIUM dCELL Dermis® HUMAN DERMIS LARGE 5CM X 5CM TP8008 TP8001 5CM X 10CM CRYOPRESERVED SPLIT SKIN LARGE PACK IRRADIATED SPLIT SKIN LARGE PACK MINIMUM 330 CM2 TP8003 MINIMUM 330 CM2 Cost recovery will include next day delivery by 1pm for tissue products 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 (Template Version 07/10/08) Cross-Referenced in Primary Document: SOP332 Page 12 of 12