FRM234jan2015.doc

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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
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