FRM234 Application Form (AH 03NOV14).doc

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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
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