CORD BLOOD STORAGE AGREEMENT
Document Sample


Client Reference No: _________________ Form 1
CORD BLOOD STORAGE AGREEMENT
The purpose of this document is to explain the terms, conditions, limitations, risks and costs of the collection,
processing, testing and storage in a Smart Cells International Limited (SCI) authorised cellular processing and storage
laboratory (Laboratory) of stem cells obtained from umbilical cord blood (cord blood unit) collected at the time of
birth of the child(ren) of the undersigned parent(s)/guardians (You). This document also constitutes a legally binding
Agreement between SCI and you the undersigned (the Parties). This Agreement expressly limits the rights and
obligations of the parties as set forth in this document. By signing this Agreement you the undersigned agrees to the
processing and storage of the Cord blood unit in any SCI authorised Laboratory and indicates that I (we) have been
fully informed of, accept and agree to the conditions, risks, limitations and costs of such storage.
If both parents/legal guardians sign this Agreement then you understand that you are both fully liable to us for
performing your obligations under this Agreement and we are entitled to act on the instructions of either one of you.
The parent instructing SCI indemnifies SCI in the case that there is disagreement between the parents in relation to
the instructions acted upon.
You understand that cord blood stem cell transplantation is a relatively new technique and may offer possible future
benefits to the child and other potential beneficiaries in treating diseases such as leukaemia, and blood and genetic
disorders. Also, you understand that cord blood offers a source of stem cells, and that you acknowledge that you are
aware of alternative sources of stem cells such as bone marrow and circulatory blood. You understand that
cryopreservation of cord blood is a relatively new procedure and some laboratory tests and studies so far have
indicated it is a successful method of preserving cord blood. However, it is important that you are aware that
no assurance or guarantee can be made about the effectiveness of preservation nor the benefits or
utility derived from it. You also understand that the child or another family member may never need to use the
cord blood unit.
1 COSTS
1.1 You will be provided with a statement detailing the package you have chosen and the costs incurred. The
deposit is due upon placing your order and is non-refundable. The processing, storage and any additional
costs of collection are due 30 days after the receipt of the cord blood unit at our processing Laboratory.
The total cost payable depends on the SCI service package selected. You will be notified by SCI once the stem
cells have been successfully stored and invoiced for the remaining balance (“Notification”) for processing and
storage.
1.2 IMPORTANT – You acknowledge and understand that this Agreement is only between SCI and you the
undersigned.
Where the collection process is carried out by a qualified healthcare professional appointed by you, it is your
sole responsibility to arrange the collection in accordance with SCI’s cord blood collection procedure protocol.
You must make yourself familiar with the collection procedure protocol in your Collection Kit and ensure that
your appointed person for the collection is familiar and comfortable with it.
Where the collection process is carried out pursuant to the SCI Phlebotomist service please note that we are
not responsible for the collection process but we will take all reasonable steps to ensure that our recommended
phlebotomist is familiar with the collection kit. We will not assume any liability in relation to the performance
of their services.
1.3 You the undersigned acknowledge and agree that SCI is not responsible for any medical procedure or advice.
If the cord blood unit is not collected in accordance with the cord blood collection procedure protocol, you
understand that it may affect the viability of the cord blood unit for storage and/or future use.
1.4 You understand that the cord blood unit is normally discarded after delivery, appropriated for medical research
or stored in a public banking facility and that the decision to collect process and store the child’s cord blood unit
is a voluntary act on your part that may allow you to protect your child’s personal rights to the cord blood unit.
Contact Smart Cells on 020 7436 9966 1
1.5 You understand that there are risks with any medical procedure, that there may be additional considerations
or unforeseeable circumstances during the delivery of your child and which may affect the collection of the
cord blood unit. The safety and care of the child and mother are of primary concern. You therefore
acknowledge and agree that the qualified medical professional may, for any reason and at their discretion,
refuse to collect the cord blood unit. This is not something within the control of SCI. If the cord blood unit is
not collected for any reason, you may cancel this Agreement by notifying SCI. Your initial deposit is non-
refundable.
1.6 Once the cord blood unit has been collected, it is your responsibility to ensure that the collection kit is labelled
correctly and the Sample Identification Form is signed to confirm that it is your child’s cord blood unit contained
in the collection kit. If you have more than one child and have more than one collection kit, you must clearly
identify each child on their respective collection kit.
2 EXAMINATIONS
2.1 It is essential that you provide two maternal blood results.
(a) The first maternal blood test is due no earlier than 30 days prior to and no later than 7 days after the birth.
(b) The first maternal blood or the maternal blood result must accompany the cord blood sample being sent
to the laboratory. Results are required for HIV 1 & 2 antibodies, Syphilis, Hepatitis B surface antigen,
Hepatitis C antibodies and HTLV.
(c) The second maternal blood test is due 180 days after the date of birth of your baby – a blood testing kit
will be sent to you, you must arrange for the blood to be taken.
2.2 In signing this Agreement, you the undersigned acknowledges and agrees that SCI is in no way providing
medical advice, care or treatment to the client or anyone else.
2.3 It is the responsibility of the undersigned to ensure the 1st and 2nd blood tests are completed on time and sent
to the laboratory for processing. Failure to do this may invalidate the cord blood sample storage. Parents would
still be liable for full payment.
3 PROCESSING, STORAGE AND WITHDRAWAL
3.1 You the undersigned are responsible for contacting either SCI or the SCI approved courier company as soon
as possible following collection of the cord blood unit to allow the cord blood unit to reach the SCI designated
processing and storage laboratory.
3.2 SCI agree to make a full refund of processing and storage fees paid if within the first 12 months from the
storage date the sample is retrieved for therapeutic use.
3.3 SCI appoints a courier for the transportation of the cord blood unit. Details of how to pack the cord blood unit
to ensure safe delivery are included in your Collection Kit, however SCI are not liable for unforeseen
circumstances.
3.4 On receipt of the cord blood unit SCI will process the cord blood unit and provided a sufficient number of stem
cells can be isolated from the cord blood unit we will store and preserve such stem cells on your behalf. SCI
operates a clear success criterion. Any unit falling below this criterion will be notified to you and may not be
stored.
3.5 If you choose not to store a borderline case you do not pay any storage costs. You are still liable for the
processing fee.
3.6 Any SCI customer deciding to cease storage of a cord blood unit after it has been stored, will be charged a
fee for the disposal.
3.7 The Laboratory where the cord blood unit is to be stored is operated and controlled by a third party. We do
not accept any liability for their operation or activities.
3.8 Consent is expressly given to store a variety of human tissue in the laboratory. The cord blood unit may be
stored with any other type of human tissue in the laboratory but no other cord blood unit will be commingled
with the cord blood unit or placed within the same bag where the cord blood unit is stored.
3.9 Consent is expressly given to the SCI designated processing and storage facility to perform all associated tests
on cord blood.
3.10 SCI may (i) transfer the cord blood unit to another laboratory (ii) transfer the location of the laboratory or (iii)
assign any or all of its rights under this Agreement. If SCI intends to do any of the foregoing, it shall promptly
notify you the undersigned.
2
3.11 The cord blood unit shall at all times be owned by the maternal mother or legal guardian and shall be subject
to the exclusive control of you the undersigned provided however, upon majority being the age of 18,
ownership and control over the cord blood unit shall automatically transfer to the person whose cord blood
unit is being stored, unless said person or a court of law shall assign the said right in writing to you the
undersigned or other third party. Once your child reaches 18, in the event of any conflict between your request
and the requests of your child, we will be bound by the requests of your child.
3.12 SCI’s obligations and liabilities are expressly limited to the services described in section 3 and no other services
are provided. SCI expressly disclaims any responsibility to provide any other services.
3.13 SCI will contact you in writing at the last address you have given us six months prior to the end of the twenty
five (25) year storage term. If you elect to continue to permit SCI to store the cord blood unit on your behalf,
SCI will invoice you for continuing storage costs at its then current rates.
3.14 SCI cannot be held responsible for any loss, damage or detritions of the sample due to its transit to the
laboratory or to any third party, once the sample has been retrieved and SCI cease to store the sample.
4 TERMS AND TERMINATION
The cord blood unit shall be stored for the terms specified in accordance with the following conditions:
4.1 SCI reserves the right to refuse to process a sample cord blood unit where the volume of the cord blood sample
is insufficient.
4.2 SCI reserves the right to refuse cord blood unit storage for any reason.
4.3 In the event that full payment has not been received within thirty days of Notification, SCI may terminate this
Agreement, destroy the stored cord blood unit, and take such steps as may be necessary to recover the
Processing and Storage Fee. An additional charge will be incurred to cover the correct disposal of the sample.
4.4 Smart Cells International have a clear success criteria for cord blood units, in the event a cord blood unit is
below this criteria then you will be notified in order for a decision to be taken by you the undersigned to store
or not. With “borderline” cases, you the undersigned will be liable for the processing costs.
In the event that the sample is classed as a complete “fail” the you will not be charged processing or storage
fees if you decide to not store.
4.5 This Agreement may be cancelled by the undersigned at any time prior to the collection of the cord blood unit
at birth. You will not be charged the balance due, but will be responsible for the initial payment.
4.6 It is the responsibility of Parents to notify SCI in the case of relocation or address change or changes to your
personal circumstances in relation to your cord blood unit storage.
5 GUARANTEE
5.1 We guarantee to you that:
5.1.1. The Collection Kit is of satisfactory quality and fit for the purpose of collecting the cord blood unit as
set out in the cord blood unit collection procedure protocol and this Agreement.
5.1.2. The services will be provided using reasonable care and skill and, provided that you comply with your
obligations, in accordance with this agreement.
5.2 You acknowledge and accept that SCI cannot give any guarantees with respect to any suitability of the cord
blood unit for the future treatment of diseases or the successful treatment of diseases through cord blood unit
transplantation.
5.3 Under the Agreement, you permit SCI to enter and maintain relevant data for its own use. In case of a medical
emergency, SCI will be permitted to provide this data, in writing, to a treating doctor or other institution. SCI
will not, without receiving express permission in writing, show or pass the data regarding your cord blood unit
to a third party.
5.4 IMPORTANT – You acknowledge and accept that we cannot give any guarantees with respect to any:
5.4.1. Suitability of the cord blood unit for the future treatment of diseases;
5.4.2. Successful treatment of diseases through the cord blood unit transplantation; or
5.4.3. Advantages of the cord blood unit transplantation over other types of treatment using stem cells;
You the undersigned enter into this Agreement with this understanding.
3
6 LIMIT OF SCI’S LIABILITY
6.1 If you suffer any loss or damage due to our fault or negligence, or the fault or negligence of any of our
employees, agents or contractors, we accept responsibility for that loss or damage and shall reimburse the
client for any direct losses you suffer which we could have reasonably foreseen at the date of this Agreement
up to the total of the fees paid by the Client to us (unless such loss or damage relates to death or personal
injury caused by SCI).
6.2 SCI or personnel collecting the cord blood unit shall not be liable to you when due to unforeseen
circumstances, the collection of the cord blood unit is not possible, or the amount of blood taken proves to be
insufficient or the Cord blood unit is contaminated.
6.3 You acknowledge and understand that we shall not be liable to you, or be considered to be in breach of this
Agreement, because of any delay in performing, or any failure to perform, any of our obligations if the delay
or failure was due to your acts or omissions or to any other cause beyond our reasonable control.
6.4 Should there be loss of the cord blood unit whilst in the care of SCI, which was beyond SCI’s control, SCI will
reimburse a proportion of the fees (on a pro rata basis for the remaining storage term).
7 CONFIDENTIALITY AND DATA PROTECTION
7.1 SCI will use all reasonable endeavours to keep confidential all information relating to you and your child. All
samples to be tested will be labelled with unique reference numbers and bar coded. Personal information will
only be held on our secure database and/or database backup. Information held by SCI will only be released
if required by your or your child’s medical practitioner for their internal confidential records or otherwise as
requested by you. None of the information held on our database will be disclosed or released to third parties
other than those required by law.
7.2 SCI is registered under the Data Protection Act 1998 and will process all personal data in accordance with its
obligations under that Act. By signing this Agreement, you consent to our holding and processing of yours and
your child’s personal data (including sensitive personal data) for the purposes of performing our obligations
under this Agreement and you also acknowledge and consent to us disclosing such personal data as required
by law, to your child’s medical practitioner on request and to our use of the data and the dissemination of the
data to our partners for their use for the purposes of this Agreement or for the storage of the Sample.
SCI may make such information available to any Group Company, those who provide products or services to
the Company or any Group Company, regulatory authorities, potential or future employers, governmental or
quasi-governmental organisations and potential purchasers of the Company.
8 NOTICE
8.1 This Agreement shall be governed by and construed in accordance with English law and the parties hereby
submit to the exclusive jurisdiction of the English courts.
8.2 You the undersigned will immediately notify SCI in writing of any changes in your information. All notifications
to SCI shall be sent to: Smart Cells International, 56-58 Bloomsbury Street, London WC1B 3QT
8.3 This agreement constitutes the whole agreement between the parties and supersedes all previous agreements
between the parties relating to its subject matter.
8.4 Each party acknowledges that, in entering into this agreement, it has not relied on, and shall have no right or
remedy in respect of, any statement, representation, assurance or warranty (whether made negligently or
innocently) other than as expressly set out in this agreement.
8.5 Nothing in this clause shall limit or exclude any liability for fraud.
for and on behalf of Smart Cells International Limited
Signed ________________________________________ Signed _______________________________________
Shamshad Ahmed Parent/Guardian
Chief Executive Print Name ___________________________________
Date As postmarked
_______________________________________ Date _______________________________________
4 Aug08
Get documents about "