INFORMATION DOCUMENT INF965/2
Effective: 02/10/14
NCI Customer Guide
INTRODUCTION
NHSBT endeavours to minimise waste from the donations generously given to us by
donors. Inevitably, however, there is material which is surplus to clinical
requirements or unsuitable for therapeutic use.
Where such donations are unsuitable for, or unable to be used in, clinical provision,
NHSBT is in the unique position of being able to supply donated material for use in
our own research and development and to the wider NHS and to authorised
organisations for specific approved “non clinical” uses.
NHSBT’s donor consent procedure includes provision for such materials to be used
to benefit patients indirectly for:
1) In-vitro diagnostic tests & laboratory Quality Control including EVA and/or
2) Training and Education and/or
3) Product/Service development of Reagents, new components and procedures
and/or
4) Commercial production of reagents and blood test kits.
NHSBT will not supply donated material for:
1) Administration to humans, or
2) Use in the manufacture of any product that may be administered to humans, or
3) Use as a tissue culture medium supplement.
Whilst we do not charge for blood products, which are generously donated by
donors, we do need to recover the costs of processing them and handling requests
for donated materials.
This Customer Guide provides information to organisations and individuals who wish
to request a supply of donated material for non clinical use.
Subject area
GENERAL GUIDANCE
THE APPLICATION PROCESS
THE APPLICATION FORM
PRODUCT INFORMATION AND SPECIFICATION
INTENDED USE
LICENSING
GENETIC RESEARCH
ACCOUNT CREATION
HANDLING AND DISPOSAL OF MATERIALS
AUTHORISED PERSONS
APPLICATION REVIEW BY NHSBT
RECEIVING YOUR MATERIALS
AGREEMENT
Any queries related to completing this application can be sent to
nciadmin@nhsbt.nhs.uk
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(Template Version 07/10/08)
Author(s): Kevin Cavanagh
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GENERAL GUIDANCE
People and organisations intending to use and/or store human cells/tissue may
require licensing from the Human Tissue Authority. The storage of human cells and
tissue for ethically approved research projects may be exempt from licensing
requirements. Organisations should familiarise themselves with the legislative and
licensing requirements and industry best practice for handling and use of human
cells and tissue and confirm that they have the necessary licences, authority,
processes, procedures and resources to comply with these before requesting supply
from NHSBT.
NHSBT requires that all organisations receiving human cells and tissues for non
clinical use produce and maintain sufficient records of receipt, use, storage and
discard to provide a complete audit trail for all cells and tissues provided.
NHSBT reserves the right to inspect the records, facilities and staff of organisations
who receive human cells and/or tissue from us.
Organisations must not make available in whole or in part any cells or tissue from
material supplied by NHSBT to anyone other than those named on the application or
working directly for the named lead and for the purposes approved on their
application.
Passing on or making available any product, excess or unused part of any product to
a 3rd party of for another use is expressly forbidden. This applies whether or not the
user is internal or external to your organisation
If your research or development requires you to make samples available for external
quality assurance then this must be made clear in the application. Full details of the
organisation, recipients, intended use and fate of material provided must be supplied
with your application. Where a product is produced containing any part of the
donated material, full details of the product, intended use and availability of the
product must be provided in your application. Failure to provide this information in
full with your application may result in it being rejected or significantly delayed while
we request the information and reassess.
Organisations should be aware that an NHSBT’s regulatory inspection body may
require access to the records, staff and facilities of an organisation receiving material
from us.
THE APPLICATION PROCESS
Requests to supply materials can only be made by completing an NCI account
application form which is available here:
http://hospital.blood.co.uk/products/nci_of_blood_components/
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
application forms must be clearly legible therefore any application that is not
typed, word processed or completed in clear block capitals may be rejected
all applications are treated as commercial in confidence
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
successful applications usually take 4-6 weeks to set up after receipt of a
properly completed application form. After this time, successful applicants will be
able to order the materials for which they have been approved
THE APPLICATION FORM
The first section of the form is designed to capture the essential contact and
customer details we need to set up and administer the account as well as details of
where to send invoices. Whilst we do not charge for blood products, which are
generously donated by donors, we do need to recover the costs of processing them
and handling requests for donated materials.
We ask for the expected start date, duration and end of proposed work so we can
accurately assess the impact of meeting your request. Where projects or intended
use is not subject to a defined end date please indicate this in the free text box.
Please Note NHSBT will indicate the maximum duration of the supply chain in the
Terms and Conditions we ask you to sign prior to any supply.
The second section of the form requests details of the products you require.
Please ensure the correct product/s is/are requested as you will only be authorised
and able to order products on your application.
The anticipated typical volume of material required and frequency of order must also
be provided so we can assess our ability to supply. NHSBT cannot authorise
accounts for unspecified amounts of materials therefore incomplete applications will
be rejected.
PRODUCT INFORMATION AND SPECIFICATION
Current consent allows NHSBT to provide material with the following donor
information, where known:
a. Year of birth
b. Gender
c. CMV status (if known)
d. Blood Group
Requests for material with more detailed information will be assessed on a case by
case basis and may take longer than 4-6 weeks for review. If approved they may
require the development of a bespoke consent and supply process which will need to
be fully cost-recovered. It may not be possible to approve these requests if the
impact on clinical supply chains is significant.
NHSBT is mandated to screen all donated blood components for HIV 1&2, HTLV,
Hepatitis B, Hepatitis C and Syphilis.
Leucocyte Cones
Leucocyte Cones are issued untested. Cones are acquired from donors who have
previously, often repeatedly, tested negative for all the tests NHSBT is mandated to
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perform and are only allowed to donate after successfully completing a lifestyle
questionnaire that ensures they remain a low risk.
However, all biological material must be treated as potentially infectious and
universal precautions applied when handling and working with them. A biohazard
waiver will therefore need to be signed by Cone recipients prior to any supply,
confirming they have suitable processes and procedures in place to handle and
dispose of biohazard materials.
Buffy Coats
Buffy Coats may also be requested for issue prior to testing results being known if
ultra fresh cells are required. In such cases a bio hazard waiver will need to be
signed by recipients stating they are aware of untested status and have suitable
processes and procedures in place to handle and dispose of biohazard materials.
General handling of donated materials
Donors will have often repeatedly tested negative for all the tests NHSBT is
mandated to perform and are only allowed to donate after successfully completing a
lifestyle questionnaire that ensures they remain a low risk. However all biological
material must be treated as potentially infectious and universal precautions applied
when handling and working with them
INTENDED USE
Section 1 on page 2 of the form requests details of the intended use of the materials
you require. If the intended use is for research then you are requested to provide
details of the ethical approval status of the proposed work or that a valid HTA licence
is in place. Applications for material for research use may be approved in principle
while awaiting ethical approval but no material will be supplied until Ethical Approval
has been granted and details provided to NHSBT.
The source of funding for the research or development proposal is also requested.
These details must be provided in full. NHSBT is mandated to consider the
requirements for explicit informed consent from donors on a case by case basis
when supplying material on a commercial basis. Therefore full disclosure of the
funding source is required.
Incomplete information may result in the application being rejected. All information
supplied in support of an application is treated as commercial in confidence.
LICENSING
Section 2 on page 2 requests details of any HTA Licence held by organisations
requesting supply of material which include human cells and tissue.
The HTA provides guidance on assessing whether or not the acquisition, storage,
processing or distribution of human cells requires a HTA licence.
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The following link to the HTA website provides a flowchart for assessing licensing
requirements:
http://www.hta.gov.uk/_db/_documents/Do_I_need_a_licence_under_the_Quality_an
d_Safety_Regulations_5.0.pdf
Organisations requesting human cells or tissue must ensure that their methods of
use and storage are appropriate, licensed (where necessary) and that there are
sufficient records of receipt, use, storage and discard to provide a full audit trail of
the use and outcome of all cells provided.
Further advice and guidance is available from the Human Tissue Authority and the
Medical Research Council.
GENETIC RESEARCH
The next question relates to use of material for Genetic Research. NHSBT is
mandated to ensure that the use of material for Genetic Research is in accordance
with guidelines issued by the Human Genetics Commission. We may not be able to
provide material for many forms of genetic research without developing a bespoke
process and consent.
ACCOUNT CREATION
Page 3 of the application deals captures the remaining details required to set up an
account.
Please use section 1 on page 3 to indicate whether or not you hold a HTA licence
and if so provide details of the licence held.
HANDLING AND DISPOSAL OF MATERIALS
The next section captures details of the systems and processes you employ to
ensure the safe and appropriate handling and disposal of human cells and tissue.
NHSBT reserve the right to audit or inspect any or all facilities, systems and people
involved in the handling and disposal of supplied material.
AUTHORISED PERSONS
The third section of page 3 is to record the names and roles of the persons in your
organisation who are authorised to place, amend and cancel orders and accounts.
Instructions and orders relating to accounts will only be accepted from persons
authorised to undertake these activities. Any change to authorised persons must be
requested by way of a revised application.
APPLICATION REVIEW BY NHSBT
Following receipt of your correctly completed application the request will be reviewed
by medical, manufacturing and Finance representatives to ensure the use and
supply of materials is appropriate and consistent with NHSBT policy. We aim to
complete this review and set up approved accounts for standard products within 4-6
weeks of receipt of completed paperwork, bespoke requests or large volume
requests of specific typing, serology or other specification will take longer.
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Please note: It is a condition of continued supply that users accept and sign
NHSBT’s Terms and Conditions.
RECEIVING YOUR MATERIALS
Our preferred option is for customers to arrange their own collection of materials
from a designated NHSBT centre at an agreed time. This may be undertaken in
person or via a courier arranged by the customer at the customer’s expense.
NHSBT may be able to arrange for a courier to deliver products, dependent on
recipient location but this will incur a charge, currently around £53 for the first 45
miles inside the M25 (55 miles outside the M25).
Additional mileage will be charged for deliveries arranged by NHSBT outside of this
area.
Please indicate at the time of ordering what your requirements are, there is a space
on the order form to do so.
AGREEMENT
All supply chains will be covered by a signed Material Transfer Agreement (“MTA”)
with Terms and Conditions which define the supply and use of materials.
All recipients of donated material must consent to NHSBT auditing their facilities,
records and staff as required to ensure compliance with these agreements and
authorised use.
This Customer Guide provides information to organisations and individuals who wish
to request a supply of donated material for non clinical use. The information in this
Guide does not form part of any contract to supply which will be set out in our
Agreement with you.
(Template Version 07/10/08)
Author(s): Kevin Cavanagh
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