NCI Customer Account Application

FORM FRM234/3.1 Effective: DRAFT NCI No.______NCI Customer Account Application

Customer and Institution Information Customer Customer Title, name and Department position Customer Telephone Customer Fax Customer Email Institution Name Company Registration No. Institution Address Existing NHSBT NCI Customer No. (if applicable) Is this application for a new project?

Customer Finance Department Information

ResponsibleFinanceProject Information Dept Persons - please list the persons you want authorised to request products, suspend or amend accountContactProposed detailsName project and START orders Date for this account: Proposed project END Date NameFinance Dept Role within your organisation Email and phone details Address (if different from institution address) Finance Dept Telephone No.

Finance Dept Fax No. Finance Dept Contact Email

NHSBT Internal Use

EAS £______

Finance approval: Yes / No (please circle)

Check performed by:______

Signature:______Date:______

Cross-Referenced in Primary Document: SOP332 Page 1 of 13 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 MARK application form, a guide to completion of which is available at BELOW if Further http://hospital.blood.co.uk/products/nci_of_blood_components/ you require information components available at A. BLOOD and BLOOD COMPONENTS APPENDIX A B. CORD BLOOD APPENDIX B C. PATIENT SAMPLES from RED CELL IMMUNOHAEMATOLOGY (“RCI”) APPENDIX C D. CELLULAR AND MOLECULAR THERAPIES APPENDIX D E. THERAPEUTIC APHERESIS SERVICES APPENDIX E F. TISSUES APPENDIX F G. HISTOCOMPATIBILITY AND IMMUNOGENETICS (“H&I”) 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:______

Appropriate Use

Please confirm the purpose for which products are required: Yes No 1) EQA, IV diagnostics or Laboratory QC 2) Education & Training 3) Service/Product Development 4) Research & Development

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:

HTA License held YES NO LREC/NREC reference number Source of funding Will the material be used in any form of genetic research YES NO If “YES”, please provide details:

NHSBT Internal Use

Request approved Yes / No (please circle)

Consultant/Functional lead Review by:______

Escalated to CARE Yes / No

To escalate, complete FRM4623, send to CARE member and [email protected]

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 Number of Frequency units required (weekly, monthly etc) 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 NC50 Clinical Spec Research Red Cells 220–340ml approx.

Cross-Referenced in Primary Document: SOP332 Page 5 of 13 FORM FRM234/3.1 Effective: DRAFT NCI No.______NCI Customer Account Application APPENDIX B: CORD BLOOD

Product Number of Frequency units required (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

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 Condition Number of Frequency sample samples (weekly, required ml required monthly etc)

Cross-Referenced in Primary Document: SOP332 Page 7 of 13 FORM FRM234/3.1 Effective: DRAFT NCI No.______NCI Customer Account Application APPENDIX D: CELLULAR AND MOLECULAR THERAPY PRODUCTS

Product Volume per Number of Frequency unit units required (weekly, monthly etc) 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

NOTE: All materials are supplied cryo preserved

Cross-Referenced in Primary Document: SOP332 Page 8 of 13 FORM FRM234/3.1 Effective: DRAFT NCI No.______NCI Customer Account Application APPENDIX E: THERAPEUTIC APHERESIS

Product Volume per Number of Frequency unit units (weekly, required monthly etc) 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, 2 litres single patient approx. NOTE: There is usually less than 1 unit a year available

Cross-Referenced in Primary Document: SOP332 Page 9 of 13 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 Product Volume per unit Number Frequency Code of units (weekly, required monthly etc) TP2003 Dried washed irradiated cancellous cubes 10x10x10mm (Pack 5) TP2005 Dried washed irradiated cancellous chips 6x6x30mm (Pack 5) TP2006 Dried washed irradiated tricortical wedge 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 70cc cancellous/cortical mix TP3003 Freeze-dried washed irradiated 15cc cancellous/cortical - coarse TP3004 Freeze-dried washed irradiated 35cc cancellous/cortical - coarse TP3005 Dried washed irradiated cancellous/cortical - 15cc medium TP3006 Freeze - dried washed irradiated 35cc cancellous/cortical - medium TP3007 Dried washed irradiated cancellous/cortical -– 15cc fine TP3008 Dried washed irradiated cancellous/cortical -– 35cc fine TP4001 Osteochondral cryopreserved whole patella 11 TP4008 Osteochondral cryopreserved femoral condyle 1 left lateral TP4009 Osteochondral cryopreserved femoral condyle 1

Item Product Volume per unit Number Frequency Code of units (weekly, required monthly etc) right lateral TP4010 Osteochondral cryopreserved proximal tibia left 1 lateral TP4011 Osteochondral cryopreserved proximal tibia 1 right lateral TP4012 Osteochondral cryopreserved femoral condyle 1 left medial TP4013 Osteochondral cryopreserved femoral condyle 1 right medial TP4014 Osteochondral cryopreserved proximal tibia left 1 medial TP4015 Osteochondral cryopreserved proximal tibia 1 right medial TP5009 Putty 1cc 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 Frozen washed irradiated proximal humerus 1 left TP4020 Frozen washed irradiated proximal humerus 1 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 TP6001 Frozen whole achilles with bone block >16cm

Item Product Volume per unit Number Frequency Code of units (weekly, required monthly etc) TP6002 Frozen whole patella tendon – with bone block 1 TP6003 Frozen whole patella tendon – with pre- 1 shaped bone block TP6004 Frozen whole semitendinosus long >27cm 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 TP6016- Meniscus is available either right or left and in Tendons are 18 a range of sizes. Please contact Customer supplied either Care. decontaminated or irradiated. Please specify at time of ordering. TP6016 Cryopreserved meniscus whole 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 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.

Cross-Referenced in Primary Document: SOP332 Page 13 of 13