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Welcome Pack & Service Agreements

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Your baby's cord blood contains stem cells that hold the promise of the next generation of medical therapies. The Cells4Life Welcome Pack contains an overview of the benefits and all our agreements.

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Page 1: Welcome Pack & Service Agreements
Page 2: Welcome Pack & Service Agreements

“The original motivation for starting Cells4Life back in 2002 was a personal one. We both wanted to preserve our own children’s umbilical FRUG�EORRG�VWHP�FHOOV�DW�WKH�WLPH�RI�WKHLU�ELUWK�DQG�FRXOGQ·W�ÀQG�D�suitable service. Being doctors, we were naturally aware of the medical EHQHÀWV�RI�VWHP�FHOOV�LQ�WUHDWPHQWV�OLNH�FKLOGKRRG�OHXNDHPLD��+XJH�investments in research were also being made worldwide covering other cancers, heart disease, burns therapy and organ repair and regeneration.

We wanted a UK based, professional organisation that offered the level of service and support we felt was necessary for such a specialised medical practice. We were also keen to store the whole cord blood, not just the stem cells, as a number of medical experts have alluded to other therapeutic properties in the umbilical cord blood apart from the stem cells themselves. We found that the only services available on the PDUNHW�DW�WKH�WLPH�GLGQ·W�IXOÀO�RXU�VWULQJHQW�FULWHULD��7KHUHIRUH��ZH�FUHDWHG�&HOOV�/LIH�DQG�WKH�ÀUVW�FRUG�EORRG�VDPSOHV�ZH�VWRUHG�EHORQJHG�to our own children.

:KHQ�ZH�ÀUVW�ZURWH�WKLV�:HOFRPH�3DFN�WKH�SXEOLVKHG�GDWD�LQGLFDWHG�that only 1 in 40,000 people would ever undergo a stem cell transplant, now this is 1 in 2001. Within a few years, I believe this will almost be 1 in 1 - the future with stem cells holds untold possibilities.”

the experts in stem cell storage

'U�-HII�'UHZ�%6F��+RQV��3K'���6FLHQWLÀF�'LUHFWRU��&HOOV�/LIH�

_________________1 Gluckmann, 2008

Page 3: Welcome Pack & Service Agreements

What are stem cells?

Page 3

Stem cells are “naïve” cells that can, with the right stimuli, transform into many other cell types found in the human body. Serving as a sort of repair system for the body they can theoretically divide without limit to replenish other cells.

When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialised function, such as a muscle cell, a red blood cell or a brain cell.

The umbilical cord blood and tissue (Cord Blood) contain many types of stem cell including Haematopoietic Stem Cells (HSCs), Very Small Embryonic Like stem cells (VSELs), Mesenchymal Stem Cells (MSCs) and Unrestricted Somatic Stem Cells (USSCs).

Whist the primary stem cell type found within the cord tissue is MSCs, the cord tissue also contains Vascular Endothelial and Perivascular Cells; both RI�ZKLFK�ORRN�LQFUHDVLQJO\�OLNHO\�WR�EH�WKHUDSHXWLFDOO\�EHQHÀFLDO�

It is these properties and the fact that the umbilical cord is a rich source of stem cells that has prompted many parents to save their children’s Cord Blood to potentially treat or prevent injury, disease, and other medical conditions now and in the future.

Page 4: Welcome Pack & Service Agreements

Why save umbilical cord blood and tissue?

Page 4

Storing your newborn child(ren)’s stem cells is an opportunity to use nature’s own building blocks to treat a variety of conditions now and in the future.

Current and future therapies and the family

Today, more than 200,000 cord blood units have been stored and used since WKH�ÀUVW�GLUHFW�GRQDWLRQ�IURP�D�VLVWHU�WR�D�EURWKHU�LQ�������,Q�IDFW��VWHP�FHOOV�DUH�QRZ�VWDQGDUG�FDUH�IRU�PDQ\�GLVHDVHV�

7KH�UHDO�SURPLVH�RI�VWHP�FHOO�WKHUDS\��KRZHYHU��OLHV�DKHDG�RI�XV��5HVHDUFK�LV�FXUUHQWO\�XQGHUZD\�LQWR�WKH�WUHDWPHQW�RI�D�ZLGH�YDULHW\�RI�GLIIHUHQW�medical conditions including ischemic heart disease, cancer, spinal cord OHVLRQV��ERQH�IUDFWXUHV��EXUQV��VWURNHV��0XOWLSOH�6FOHURVLV��$O]KHLPHU·V�GLVHDVH��3DUNLQVRQ·V�GLVHDVH��+XQWLQJGRQ·V�GLVHDVH�DQG�GLDEHWHV��$OO�KDYH�VKRZQ�SRVLWLYH�UHVXOWV�

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Regenerative medicine

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,W�LV�D�QRYHO�DSSURDFK�WR�PHGLFLQH��0RVW�WKHUDSHXWLF�DSSOLFDWLRQV�DUH�VWLOO�experimental or in clinical trials but the SHUVSHFWLYH�LV�EULJKW�DQG�DSSHDOLQJ�

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Page 5: Welcome Pack & Service Agreements

Wh

y save um

bilical cord blo

od an

d tissue?

Page 5

Clinical trials

Even with just the therapies existing today, it is estimated that the lifetime SUREDELOLW\�RI�XQGHUJRLQJ�DQ�DXWRORJRXV��XVLQJ�WKH�ERG\·V�RZQ�VWHP�FHOOV��WUDQVSODQW�LV�DSSUR[LPDWHO\���LQ������*OXFNPDQQ���������+RZHYHU��WKH�QXPEHU�and types of clinical trials investigating various diseases and disorders are increasing every year making the possibility even more likely.

It is worth noting that worldwide the case for banking is considered of special importance where a sibling has a transplantable disease and where the tissue W\SLQJ�LV�PRUH�GLIÀFXOW��HJ�LQ�PLQRULW\�HWKQLF�JURXSV�

Key points

Cord Blood is usually treated as waste.

It is a safe and painless process to procure and store Cord Blood.

Matched donors can be found from public registries however for some patients WKH�OLNHOLKRRG�LV�UHGXFHG�GXH�WR�ODFN�RI�DYDLODELOLW\�RI�GRQRUV��HJ�PL[HG�UDFH�SDWLHQWV��

Clinical trials are ongoing in a number of key areas and for a number of diseases however this does not mean that treatments will be approved.

Umbilical cord stem cells are not the same as embryonic stem cells.

Technical comment

Umbilical cord blood contains many types of stem cell LQFOXGLQJ�+6&V��96(/V��06&V�DQG�866&V��7KHVH�KDYH�EHHQ�shown to develop into other tissue types, for example cardiac, neurological, pancreatic and skin.

Umbilical cord blood also contains high concentrations of cytokines, growth factors and hormones, B-cells and T-cells. These are lost in extracting stem cells.

Transfusion of whole cord blood shows faster engraftment than extracted stem cells, attributed to these components. :KLWH�EORRG�FHOOV��%��7�FHOOV��DUH�NQRZQ�WR�EH�DIIHFWHG�by ageing, and it has been proposed that “autologous white blood cells collected and cryopreserved represent a valuable bioresource for the restoration of immunity, and the successful development of adoptive immunotherapies in treating infections and cancer, particularly in the ageing SRSXODWLRQ�µ��&KDUURQ�,16(50�8�����

Page 6: Welcome Pack & Service Agreements

Why Cells4Life?

Page 6

´&HOOV�/LIH�LV�DERXW�JLYLQJ�SDUHQWV�D�FKRLFH��%\�PDNLQJ�FOLQLFDO��VFLHQWLÀF�DQG�HYLGHQFH�EDVHG�LQIRUPDWLRQ�DYDLODEOH�WR�SDUHQWV�ZH�KRSH�WR�DOORZ�WKHP�WR�PDNH�DQ�LQIRUPHG�GHFLVLRQ�DERXW�FRUG�EORRG�VWRUDJH��:H�DUH�ZRUNLQJ�YHU\�KDUG�WR�VHW�WKH�JROG�VWDQGDUG�LQ�WKH�WHVWLQJ��SURFHVVLQJ�DQG�DVVHVVPHQW�RI�WKHVH�SUHFLRXV�VDPSOHV��7KH�8.�LV�RQH�RI�WKH�OHDGLQJ�FRXQWULHV�LQ�VWHP�FHOO�UHVHDUFK�DQG�GHYHORSPHQW��ZH�ZDQW�WR�UHPDLQ�DW�WKH�FOLQLFDO�IRUHIURQW�RI�WKLV�LQ�RUGHU�WR�EHQHÀW�SDWLHQWV�µ

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Founded by doctors

Cells4Life is a science-led organisation founded by doctors in 2002. We store more UK samples than any other private bank. All parents receive support from our team of doctors, scientists and specialists who provide the highest level of FRQÀGHQWLDO�FDUH��DGYLFH�DQG�H[SHUWLVH�

Only UK company to store whole cord blood

Unlike other UK stem cell storage companies we store the whole cord blood not MXVW�VRPH�H[WUDFWHG�VWHP�FHOOV�

Leading UK transplant services currently use whole cord blood when treating blood diseases.

Work published in international peer reviewed press has shown the superior HQJUDIWPHQW�RI�ZKROH�FRUG�EORRG�WUDQVSODQWV�YHUVXV�H[WUDFWHG�VWHP�FHOOV��[Savarese, T.M. et al (2007) Breast Cancer Res.]

Whole cord blood contains many different kinds of stem cell and other factors that may play a vital role in future medical therapies.

Separation of the stem cells (volume reduction) causes many stem cell types to be lost and removes all of the other factors.

First company in the world to store whole cord blood and tissue

By complementing cord blood with a piece of the umbilical cord tissue it means that we store more key stem cell types than anyone else. We believe this give us the greatest potential to take advantage of future therapies that may require either different cell types or greater volume of cells.

Page 7: Welcome Pack & Service Agreements

Wh

y Cells4l

ife?

Page 7

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Speed of processing is a key factor in maintaining viability of your baby’s Cord Blood. To provide maximum speed and care we only use dedicated couriers to transport the sample from the hospital to our laboratory, resulting in the fastest average processing WLPH�LQ�WKH�LQGXVWU\��8QLTXHO\��ZH�XVH�VWDWH�RI�WKH�DUW�WHPSHUDWXUH�FRQWUROOHG�packaging where transit times may be lengthy.

Stringent testing

On arrival at our laboratory the sample undergoes stringent testing to ensure only Cord Blood containing a high percentage of living cells is stored. Additionally, we operate a 24/7 laboratory and perform all processing and testing in house. By performing these tests at the time of processing we can provide our customers with clear evidence of WKH�TXDOLW\�RI�WKHLU�VDPSOH�

Dual storage locations

We divide the cord blood into a number of samples. To ensure security in the event of a natural or man made disaster, we store separate samples from a single cord blood collection in two geographically separate sites. 'LYLGLQJ�WKH�VDPSOH�DOVR�JLYHV�PD[LPXP�ÁH[LELOLW\�WR�potentially enable its use for different therapies over time, if needed.

Human Tissue Authority license

Cells4Life is regulated and licensed by the Human Tissue Authority, license number 11083. This ensures our practices meet the highest standards and are in compliance with the EU Tissue and Cells Directive and Human Tissue (Quality and Safety for Human Application) Regulations 2007.

Guaranteed refund

We charge an all inclusive fee. In the event of a failure to procure or a positive testing result we will refund all fees paid except third party fees and the deposit.

Business continuity insurance

7R�HQVXUH�FRQWLQXHG�TXDOLW\�DQG�VDIHW\�RI�\RXU�FKLOG·V�&RUG�%ORRG�VDPSOH�LQ�WKH�HYHQW�of a corporate failure, Cells4Life has insurance to cover moving your sample to another storage facility.

Page 8: Welcome Pack & Service Agreements

What will happen?

Page 8

The process to store your child’s Cord Blood is simple.

If you’d like to speak to one of our medical experts for more information please feel free to call us:

01444 873 950

Step 1 Welcome Pack Read all parts of the Welcome Pack to fully understand which of the

Cells4Life services you require.

Cells4Life Group LLPUnits 2 & 3 Oak House:RRGODQGV�2IÀFH�3DUNAlbert DriveBurgess HillRH15 9TN

Step 2 Service Agreement We have enclosed two copies of our Service Agreement and the Phlebotomy

Service Terms & Conditions. These are legal documents so please read them fully and raise any questions you may have with us. Please complete your details, signing one copy of the Service Agreement before returning it to us with your payment. If you require our Phlebotomy Service, please also complete and return the Phlebotomy Service Terms & Conditions. We have included a prepaid envelope for your convenience.

Step 3 Advise hospital At your next hospital appointment,

please make sure they are aware of your desire to collect Cord Blood DQG�WKDW�\RX�KDYH�YHULÀHG�WKHLU�hospital policy on this procedure.

Step 4 Collection Kit Once we receive your signed Service Agreement, Phlebotomy Service Terms

& Conditions (if required) and payment, you will be sent the Collection Kit which will contain full procurement instructions. Ideally delivery of the Collection Kit should be arranged well in advance of your expected due date, however, we can arrange a courier in the event of an imminent delivery at additional cost.

Page 9: Welcome Pack & Service Agreements

Wh

at Will h

appen?

Page 9

Step 5 Collect Cord Blood Following the birth of your baby and delivery of the placenta, the procurer will

collect your baby’s Cord Blood and maternal sample before packaging them into our specially prepared transport bags ready for courier collection. If it not possible to obtain a maternal sample, one should be taken within 7 days of birth and sent to our laboratory.

Step 6 Call courier� 8SRQ�QRWLÀFDWLRQ�D�FRXULHU�ZLOO�FROOHFW�WKH�&RUG�%ORRG�IURP�\RX�DQG�GHOLYHU�

it directly to our state-of-the-art laboratory in the UK. Please make sure that you keep the Cord Blood with you at all times, do not leave it at the hospital reception desk.

Step 7 Testing and cryopreservation Upon arrival, we will start processing and testing your sample. It will be

separated into several segments and cryopreserved. Eventually, it will be stored in two geographically separate locations.

Step 8 Maternal sample testing All samples are tested using the latest instrumentation and assays. Cells4Life has access to specialist reference laboratories for additional testing if necessary.

6WHS��� &HUWLÀFDWH�RI�WHVWLQJ Once testing is complete you will receive a Cells4Life Umbilical Cord Blood (and

7LVVXH��7HVWLQJ�&HUWLÀFDWH�IRU�\RXU�FKLOG·V�&RUG�%ORRG��7KLV�LV�D�UHFRUG�RI�WKH�WHVW�results regarding your child’s sample.

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01444 873 950

Important note

In the UK procurement of human tissue may only take place under an HTA license eg on licensed premises or via a Third Party Agreement (TPA) with a licensed establishment. Breach of this requirement is an offence under HT Act 2004, Human Tissue (Quality and Safety for Human Application) Regulations 2007.

Page 10: Welcome Pack & Service Agreements

Frequently asked questions

Page 10

What is the difference between storing whole cord blood and extracted stem cells?

Both whole cord blood and extracted stem cell samples start from collecting the available blood from the umbilical cord. The main difference between storing whole cord blood and extracted stem cells is the methods used once the blood is received at the laboratory. Stem cell extraction methods involve high levels of sample manipulation which has been shown to increase the loss of stem cells and the risk of contamination. Methods used by Cells4Life, however, involve minimal manipulation with no separation of the blood.

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Umbilical cord blood contains several different types of stem cell. Whilst storing the whole cord blood preserves all the key stem cell types and other factors found within the blood, storing a volume reduced sample preserves only one stem cell type, HSCs. Volume reduction removes over 80% of the cells in the sample.

Is there a downside to storing whole cord blood?

1R��&RUG�EORRG�ZRXOG�QRUPDOO\�EH�XVHG�LQ�LWV�HQWLUH�VWDWH��,I�D�VSHFLÀF�WKHUDS\�UHTXLUHG�D�FHUWDLQ�FHOO�W\SH�this would be available within the sample.

Are there any treatments that will only be available to me if I store whole cord blood?

The additional cell types in whole cord blood means that whatever new therapies are developed you will have the best chance to take advantage of them. These cell types (including MSCs and VSELs) are critical for certain therapeutic treatments, tissue reconstruction, regeneration and are important for successful engraftment.

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Not to the baby. Volume reduced storage was invented to reduce the cost of storage for public stem cell banks treating blood disorders. It has been adopted by most commercial stem cell banks for this reason.

:LOO�VWRULQJ�FRUG�WLVVXH�JLYH�PH�DQ\�DGGLWLRQDO�EHQHÀWV"

Cord tissue is a rich source of MSCs. Current research has demonstrated that these cells and those from whole cord blood can form many, if not all, of the cell types necessary for tissue repair or replacement. Research is ongoing to develop therapies in areas such as heart, retinal, muscle, cartilage and bone repair and organ regeneration.

Page 11: Welcome Pack & Service Agreements

Freq

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Page 11

Why is it important to store in two locations?

When storing your baby’s stem cells for such a long time you want to know your investment is protected against natural or man-made disaster. Two geographical locations ensures you have a back up if ever needed.

What method of preservation does the UK Health Service use to store cord blood samples?

Whole cord blood storage is the process used by the UK Health Service when storing cord blood from a sibling to treat a child with leukaemia.

Can we store part of the blood for our own use and the rest for public use?

The average amount of cord blood collected is enough to treat a child with a haematological disease weighing up to about 30kg. Augmentation (cell multiplication) technologies will mean that VPDOO�QXPEHUV�RI�VWHP�FHOOV�FDQ�EH�H[SDQGHG�EXW�WKH�UHDOLW\�LV�WKHVH�WHFKQRORJLHV�DUH�VHYHUDO�\HDUV�away. Until this technology is proven Cells4Life does not recommend splitting the sample.

Can the Cord Blood still be collected if I have a caesarean or home birth?

The process is the same in either case. The important thing is to discuss it in advance with your midwife and birth partner. For caesarean birth, Cord Blood is collected after the delivery of the placenta in the same way as for a natural birth.

Is there any medical risk to either myself or the baby?

Cord Blood collection with Cells4Life occurs after the placenta has been delivered and does not add risk to mother or baby at this critical time. It is a simple, quick and safe practice. The person procuring the sample must be trained in the process to ensure the safety of mother and baby, and the integrity of the sample.

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Page 12: Welcome Pack & Service Agreements

Frequently asked questions

Page 12

Why is your initial Service Agreement limited to 25 years?

Current research has shown that cord bood stored and used after 25 years is therapeutically viable. Peripheral blood, gametes and other tissue types have been stored and used after considerably longer periods with no adverse effects. It is highly likely that it will be possible to store the umbilical cord blood and tissue for much longer periods of time and retain the clinical activity of the cells. It is widely DFFHSWHG�LQ�WKH�VFLHQWLÀF�FRPPXQLW\�WKDW�ORQJ�WHUP�FU\RJHQLF�VWRUDJH�FDQ�EH�LQGHÀQLWH�

Why is the speed of delivery and processing of the sample so important?

Medical evidence shows that the viability of the cells deteriorate over time. To ensure the Cord Blood is stored at optimum viability we aim for a maximum of 48 hours between procurement and processing. Where necessary we will provide unique temperature controlled packaging to maintain viability.

Are there any ethical considerations in collection Cord Blood?

No. There has been much controversy around the collection of embryonic stem cells but this is completely different. The collection of embryonic stem cells involves the extraction of stem cells from embryos XVXDOO\�FUHDWHG�VSHFLÀFDOO\�IRU�WKDW�SXUSRVH��&RUG�%ORRG��KRZHYHU��LV�WDNHQ�IURP�D�OLYLQJ�SHUVRQ��WKH�FKLOG��and remains their property. There is no ethical reason why it should not be preserved.

“My husband is a doctor and he found the training and instructions clear and easy to follow. The courier arrived promptly to collect the sample.”

Page 13: Welcome Pack & Service Agreements

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Page 13

What would happen if there were complications at birth?

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How quickly should the Cord Blood be collected?

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“Cord blood stem cells can be stimulated to turn into other types of cells including nerve and heart muscle. This has important potential therapeutic implications for the treatment of conditions such as stroke and heart disease, the research evidence looks very exciting.”

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Can Cord Blood be used by any other members of the family?

,W�LV�SRVVLEOH�WKDW�&RUG�%ORRG�ZLOO�EH�D�VXLWDEOH�PDWFK�IRU�RWKHU�PHPEHUV�RI�WKH�IDPLO\��DQG�SRVVLEO\�XQUHODWHG�UHFLSLHQWV�DV�ZHOO��7R�DVVHVV�WKH�FRPSDWLELOLW\�RI�WKH�&RUG�%ORRG�D�WLVVXH�W\SH�PDWFK��+/$�W\SLQJ��ZRXOG�EH�UHTXLUHG��7KLV�LV�WKH�VDPH�SURFHVV�DV�LI�ERQH�PDUURZ�RU�RWKHU�WLVVXHV�ZHUH�WR�EH�GRQDWHG��7KHUH�LV�D���LQ���FKDQFH�RI�D�PDWFK�EHWZHHQ�VLEOLQJV�DQG�ZLWK�HDFK�JHQHUDWLRQ�VWHS�DZD\�IURP�WKH�FKLOG�WKLV�FKDQFH�GHFUHDVHV��'XH�WR�WKH�QDwYH�QDWXUH�RI�&RUG�%ORRG�D�JUHDWHU�QXPEHU�RI�PLVPDWFKHV�EHWZHHQ�WKH�+/$�W\SHV�FDQ�EH�WROHUDWHG��7KLV�PHDQV�WKDW�LW�LV�PRUH�OLNHO\�IRU�D�&RUG�%ORRG�VDPSOH�WR�EH�D�WROHUDWHG�PDWFK�IRU�DQ\�SRVVLEOH�UHFLSLHQW�

What’s the difference between private and public cord banks?

,Q�WKH�8.��PRWKHUV�WKDW�JLYH�ELUWK�DW�FHUWDLQ�KRVSLWDOV�FDQ�FKRRVH�WR�GRQDWH�FRUG�EORRG�YROXQWDULO\�WR�WKH�SXEOLF�FRUG�EDQN�UXQ�E\�WKH�1+6��+RZHYHU��RQFH�WKLV�KDV�EHHQ�GRQDWHG�WKH�VDPSOH�ZLOO�EH�XVHG�IRU�DQ\RQH�ZLWK�D�FOLQLFDO�QHHG�DQG�KDV�DQ�+/$�PDWFK�WR�WKH�VDPSOH��7KHUH�LV�QR�JXDUDQWHH�WKDW�WKH�VDPSOH�ZLOO�EH�DYDLODEOH�IRU�XVH�E\�WKH�GRQRU�VKRXOG�LW�EHFRPH�QHFHVVDU\��3ULYDWH�VWRUDJH�LV�WKH�RQO\�ZD\�WR�JXDUDQWHH�D�SHUIHFW�PDWFK�DQG�UHDG\�DYDLODELOLW\�VKRXOG�\RXU�FKLOG�UHQ��QHHG�LW�

Page 14: Welcome Pack & Service Agreements

To doT

o do

Page 14

Call us to discuss who can procure your sample.

Review and complete the Service Agreement.

Receive your state-of-the-art Collection Kit from Cells4Life.

Pack Collection Kit with your maternity bag.

Cells4Life contact: ..................................................................................................

Your Collection Kit will only be dispatched following receipt of your completed Service Agreement and payment of the initial deposit.

Page 15: Welcome Pack & Service Agreements
Page 16: Welcome Pack & Service Agreements

Contact Information

For all general enquiries please call our Customer Support Team on:

+44 (0) 1444 873 950Alternatively please e-mail us on:

[email protected]:

Cells4Life Group LLPUnits 2 & 3 Oak House:RRGODQGV�2IÀFH�3DUN

Albert DriveBurgess HillRH15 9TN

www.cells4life.com

Page 17: Welcome Pack & Service Agreements

Service Agreement

Scan this QR code with your smartphone to complete our Service Agreement online.

Page 18: Welcome Pack & Service Agreements

Dear Parents,

This is the Cells4Life Cord Blood collection, testing and cryopreservation agreement and it is a legal document. We request that you read it very carefully as it sets out the entire agreement between us. $OO�RI�\RXU�LQIRUPDWLRQ�ZLOO�EH�KHOG�LQ�VWULFW�FRQÀGHQFH�

For your reference, this document is divided into the following parts:

Section 1 Parent information

Section 2 ServiceS, PlanS and Pricing information

Section 3 Statement of conSent

Section 4 medical queStionnaire

Section 5 cord Blood Procurement, ProceSSing, teSting and cryoPreServation agreement

Section 6 Payment methodS and Standing order form

Additional documents provided with the Serivce Agreement:

Section 7 PhleBotomy Service termS & conditionS

Using block capitals please fully complete Sections 1 to 6 and return one copy of the Agreement to us keeping the other for your own records. If you require any additional services, please also complete and return the additional Sections. The second copy should be kept for your records.

If you have any questions please do not hesitate to contact us.

Yours faithfully

Wayne M ChannonChairman

Page 19: Welcome Pack & Service Agreements

Page 3

Paren

t info

rmatio

nSection 1 - Parent information

Mother’s details

Mother’s name: ________________________________________________________ (“Mother”)

Date of birth: ___________________________________________________________________

Mother’s address: ___________________________________________________________________

___________________________________________________________________

__________________________________________ Postcode: ______________

Country: ___________________________________________________________________

Home telephone: ___________________________________________________________________

Mobile telephone: ___________________________________________________________________

Work telephone: ___________________________________________________________________

Fax: ___________________________________________________________________

Email address: ___________________________________________________________________

Father’s details

Father’s name: ________________________________________________________ (“Father”)

Date of birth: ___________________________________________________________________

Father’s address: ___________________________________________________________________

(if different) ___________________________________________________________________

__________________________________________ Postcode: ______________

Country: ___________________________________________________________________

Home telephone: ___________________________________________________________________

Mobile telephone: ___________________________________________________________________

Work telephone: ___________________________________________________________________

Fax: ___________________________________________________________________

Email address: ___________________________________________________________________

Birth details

Estimated delivery date: ____________________________________________________________

Name of delivering hospital: ____________________________________________________________

Person taking the sample*: ____________________________________________________________

Name of Midwife: ____________________________________________________________

Name of Obstetrician: ____________________________________________________________

Planned delivery method: Normal / Caesarean

* If you are using the Cells4Life Phlebotomy Service, please insert “Phlebotomy Service” here.

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nSection 2 - Services, plans and pricing informationCells4Life Platinum Service Plan Cells4Life is the only company in the world to offer parents the chance to store their baby’s whole cord blood and a piece of the umbilical cord. This is the most comprehensive service available and cryopreserves cord blood factor and all the stem cell types found in cord blood and the umbilical cord itself.

Cells4Life Premium Service Plan stores the whole cord blood. This service cryopreserves cord blood factor and all the stem cell types found in cord blood. Cells4Life is unique in the UK offering this service.

An initial deposit of £245 for a single birth or £490 for a twins birth is payable for the PlatinumService Plan upon booking. For the Premium Service Plan the initial deposit is £195 for a single birth or £390 for a twins birth. The Phlebotomy Service, where applicable, is also payable upon booking.

1 �$QQXDO�6WRUDJH�)HH�RI������SHU�&KLOG��VXEMHFW�WR�FKDQJH��LV�SD\DEOH�DIWHU�WKH�ÀUVW�\HDU·V�VWRUDJH�2��$QQXDO�6WRUDJH�)HH�RI�����SHU�&KLOG��VXEMHFW�WR�FKDQJH��LV�SD\DEOH�DIWHU�WKH�ÀUVW�\HDU·V�VWRUDJH�

All deposits are non-refundable

Service Plans

PlatinumService Plan

PremiumService Plan

Whole umbilical cord blood � �Cord blood Collection Kit � �Courier service � �Viability testing � �Cord blood sterility testing � �Maternal blood testing � �7HVW�UHVXOWV�FHUWLÀFDWH � �

Umbilical cord tissue �+Cord tissue Collection Kit �Courier service �Viability testing �Cord tissue sterility testing �Maternal blood testing �7HVW�UHVXOWV�FHUWLÀFDWH �

Single birth pricingPrepaid 25 Year Storage Plan £2,170 £1,695

orAnnual Payment Storage Plan £1,0951 £1,0952

OptionsPhlebotomy Service £ 275 £ 275Existing customer discount - £ 150 - £ 150

Twins special - Additional price per child2nd child Prepaid 25 Year Storage Plan £1,155 £ 855

or2nd child Annual Payment Storage Plan £ 4951 £ 4952

Total to pay: __________ __________

(plus annual Storage Fee)

(plus annual Storage Fee)

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Section 3 - Statement of consentCord Blood storage is a procedure that requires your informed consent. You may withdraw your consent to all or any of theses services at any time. We encourage you to seek advice from other sources and to ask any questions before committing to this.

Information about the lawCells4Life is fully licensed to undertake the procurement, processing, testing, storage, distribution and import/export of Cord Blood under HTA license number 11083 as required by UK and European law.

ProcurementCells4Life will send you an appropriate Collection Kit for the Service Plan you chose. The Collection Kit can only be used by a trained and licensed healthcare professional or phlebotomist. We are also required by law to obtain a maternal blood sample from you, procured at or within 7 days of birth. Birth management should not be altered. Your Midwife/Consultant should be advised of your wishes.

TransportFollowing procurement your Cord Blood sample and maternal blood sample, will be packaged into the Collection Kit box and handed to you. You must then contact the courier using the telephone number provided. Please be aware the Collection Kit box must remain with you at all times until the courier takes possession of this.

ProcessingUpon receipt at the laboratory, your cord blood sample is assessed for volume and viability - the number of living cells within the sample. Samples will have cryopreservant added to them. Blood samples will then be split into multiple portions and cryogenically frozen; tissue samples are cryogenically frozen in one portion.

TestingMaternal sample The tests required by law are: HIV I and II, HTLV (Human T-cell Lymphotropic Virus), Syphilis, Hepatitis B (both core antibody and antigen test) and Hepatitis C. You need to be aware that results of testing may provide you with previously unknown information regarding your health status. In the event of a positive result we will write to you detailing the results and advising you to seek medical advice. You are then responsible for doing this.

Cord Blood and Tissue sample All samples will be assessed for microbial sterility. In the event of a SRVLWLYH�UHVXOW�\RX�ZLOO�EH�QRWLÀHG�RI�WKH�QDWXUH�RI�WKH�FRQWDPLQDWLRQ��<RX�ZLOO�WKHQ�QHHG�WR�GHFLGH�whether you wish to continue storage or dispose of the sample and notify us of this decision.

Results reportingWe will contact you once the Cord Blood has been received and processed to inform you of the blood volume and viability. Once all other test results are completed and payment has been received we will IRUZDUG�\RXU�FHUWLÀFDWH�ZLWK�DOO�UHVXOWV�

Records and disposal&HOOV�/LIH�ZLOO�PDLQWDLQ�D�KDUG�FRS\�DQG�HOHFWURQLF�FRS\�UHJLVWHU�RI�DOO�LQIRUPDWLRQ�LQ�FRQÀGHQFH��,Q�WKH�event a sample is requested to be destroyed, this will be done by autoclaving and incineration.

%\�VLJQLQJ�WKLV�,�FRQÀUP�,�KDYH�UHFHLYHG�VXIÀFLHQW�LQIRUPDWLRQ�WR�PDNH�DQ�LQIRUPHG�GHFLVLRQ��,�FRQÀUP�P\�XQGHUVWDQGLQJ�RI�WKH�SURFHGXUHV�DQG�WHVWV�LQYROYHG�DQG�,�FRQVHQW�WR�WKHVH�

Signature of Mother

Signature: ____________________________________________________________________________

Date: ______________________________________

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reSection 4 - Medical questionnaireTo be completed by the Mother.

Please answer the following questions to the best of your knowledge providing details in the comments section below for any question(s) to which you may have answered yes.

Yes No1. Do you have or have you ever had any of the following:

i. History of a disease of unknown origin?

ii. Malignant disease?

iii. Systemic infection which will not be controlled at the time of birth, including bacterial diseases, systemic viral or fungal or parasitic

infections?

iv. History, clinical evidence or laboratory evidence of HIV, acute or chronic hepatitis B, hepatitis C, HTLV I/II or Syphilis?

v. History of chronic, systemic autoimmune disease?

vi. Recent vaccination with a live attenuated virus where a risk of? transmission is considered to exist?

vii. Transplantation with xenografts?

2. Do you or a blood relative have: i. Creutzfeld-Jacob Disease (CJD)? ii. Rapid progressive dementia? iii. Degenerative neurological disease?

3. Have you ever been the recipient of:

i. Hormones derived from the human pituitary gland?

ii. Grafts of cornea, sclera or dura mater?

iii. Undocumented neurosurgery where dura mater may have been used?

4. Have you ever ingested or been exposed to a substance (such as cyanide, lead, mercury, gold) that may be transmitted to recipients in a dose that could

endanger health?

5. Are you taking any immunosuppressive drugs?

6. Have you travelled outside the UK in the 6 months prior to your due date?

7. Have you ever knowingly acquired any disease or illness such as malaria, yellow fever, sleeping sickness?

8. Have you become ill following a mosquito bit in the last 6 months?

9. Any other known conditions, diseases or illnesses?

Comments: ______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

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Section 5 - Cord Blood procurement, processing, testing andcryopreservation agreement

This document is important and you will be legally bound by it. Please read it carefully, seek legal and medical advice and let us know if you have any questions before signing.

This Agreement is between (insert full name of Parent(s)):

___________________________________________ AND ___________________________________________ (referred to in this Agreement as “Parent” or “you”)

AND

&HOOV�/LIH�*URXS�//3��&RPSDQ\�QXPEHU�2&���������ZKRVH�UHJLVWHUHG�RIÀFH�LV�DW�8QLWV������2DN�+RXVH��:RRGODQGV�2IÀFH�3DUN��$OEHUW�'ULYH��%XUJHVV�+LOO��5+����71��UHIHUUHG�WR�LQ�WKLV�$JUHHPHQW�DV�´&HOOV�/LIHµ��“we” or “us”).

The terms and conditions contained within this Agreement together with Section 7 (where relevant) form a legally binding agreement between us which relates to the procurement, processing, testing, storage, distribution and import/export of the umbilical cord and/or placental cord blood of your Child(ren) and your maternal blood sample. In signing this Agreement, you acknowledge and agree that Cells4Life is in no way providing medical advice, care or treatment to you or anyone else.

1. General terms���� 'HÀQLWLRQV

1.1.1. “Cord Blood” means the umbilical and/or placental cord blood together with any stem cells.

1.1.2. “Child” refers to your child(ren) who is/are due on the expected delivery date as QRWLÀHG�WR�XV�DQG�LQ�UHODWLRQ�WR�ZKRVH�XPELOLFDO�&RUG�%ORRG�ZH�DUH�VXSSO\LQJ�\RX�ZLWK�D�Collection Kit.

1.1.3. “Main Service” means the collection and storage of Cord Blood. In this Agreement “collection” excludes the procurement of Cord Blood which is an optional service which may be obtained from Cells4Life by purchasing the Phlebotomy Service.

1.1.4. “Phlebotomy Service” means the phlebotomy service available from Cells4Life, as detailed in Section 7

������� ´3KOHERWRP\�6HUYLFH�7HUPV��&RQGLWLRQVµ�PHDQV�WKH�DGGLWLRQDO�VXSSOHPHQWDU\�WHUPV�contained in Section 7 which apply to the Phlebotomy Service .

1.1.6. “Deposit” means the Deposit as detailed in the “Payment methods” section set out in Section 6 of this Agreement.

1.1.7. “Services” means the Main Service if You only purchase the Main Service. In the event that You purchase either or both of the optional +Cord Service or Phlebotomy Service, “Services” shall mean all the services purchased collectively.

1.1.8. “Statement of consent” means Section 3 of this Agreement which details the Cells4Life service and which records your consent to the service particulars.

1.1.9. “Storage Fee” means the fees as detailed in the “Payment methods” section set out in Section 6 of this Agreement.

1.1.10. “Third Party Costs” means the cost of the Collection Kit, laboratory fees, any applicable courier fees and any applicable charges made by medical practitioners for procuring the Cord Blood.

1.1.11. “Tissue” means the umbilical cord tissue sample together with any stem cells.1.1.12. “+Cord Service” means the collection of Tissue in addition to Cord Blood.

1.2 The +Cord Service1.2.1. The +Cord Service is optional and additional to the Main Service. You may choose to

receive the +Cord Service only after agreeing to the Main Service. The +Cord Service is not available to you if you do not purchase the Main Service.

1.2.2. In the event that the Cord Blood is not viable for storage but the Tissue is, Cells4Life will store the Tissue notwithstanding clause 1.9. In the event that only the Tissue is stored, a charge of £860 per Child shall apply in addition to the deposit paid.

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t1.2.3. Where the +Cord Service is purchased the term Cord Blood shall in all subsequent

clauses in this Agreement include the Tissue.1.3. The Phlebotomy Service

1.3.1. The Phlebotomy Service is optional and additional to the Main Service. You may choose to receive the Phlebotomy Service only after agreeing to the Main Service. The Phlebotomy Service is not available to you if you do not purchase the Main Service.

1.3.2. Additional terms and conditions apply to the Phlebotomy Service which may be found in Section 7.

2. Your instructions2.1. Until the Child reaches the age of 18, or is deemed competent by law, we will act upon the

written instructions of you or your personal representatives in relation to the storage and use of the Cord Blood. When the Child reaches the age of 18 we are required to act upon the instructions of the Child in relation to the further storage and use of the Cord Blood. However, please note that this Agreement is between you and us and you remain liable for the payment of any fees which arise under the terms of this Agreement for the duration of the term of this Agreement.

2.2. Except where this Agreement is terminated in accordance with clause 12.3 the Cord Blood shall at all times remain the absolute and sole property of the Child and Cells4Life holds the Cord Blood on the terms set out in this Agreement.

3. Supply of Collection Kit3.1. We will send the Collection Kit to you once you have sent us the following:

3.1.1. A fully completed and signed copy of this Agreement;3.1.2. the Deposit;3.1.3. A signed copy of Section 7 (where relevant).

3.2. If you are expecting more than one Child, you must notify us and pay the Deposit (detailed in Section 6) for each Child for whom you want Cord Blood to be stored by us. A separate Collection Kit must be used for each Child and we will send you the number of Collection Kits you have requested and paid for as detailed in Section 6.

3.3. We will endeavour to send the Collection Kit to all mainland UK addresses within seven (7) working days of receipt of this Agreement and the Deposit.

3.4. We do not guarantee any time for delivery of the Collection Kit and cannot accept responsibility for any delays in delivery which are beyond our control. If you have not received your Collection Kit within fourteen (14) days, please notify us and we will investigate.

3.5. In the event that you require a Collection Kit to be sent to you by courier you are responsible for paying to us the courier costs.

����� :H�ZLOO�VHQG�WKH�&ROOHFWLRQ�.LW�WR�WKH�DGGUHVV�VSHFLÀHG�E\�\RX�LQ�6HFWLRQ���RI�WKLV�$JUHHPHQW�XQOHVV�QRWLÀHG�RWKHUZLVH�

3.7. If you notice any fault with the Collection Kit, please return it to us and we will arrange for a replacement Collection Kit to be sent to you and we will refund you reasonable postage costs for the return of the Collection Kit to us.

3.8. If you have been sent the wrong number of Collection Kits, you must contact us as soon as possible. We will then rectify the matter.

3.9. The Collection Kit is only to be used in respect of the Child due on the estimated delivery date DV�QRWLÀHG�WR�XV�LQ�6HFWLRQ����7KH�&ROOHFWLRQ�.LW�LV�XQLTXHO\�EDU�FRGHG�WR�UHIHU�WR�\RX�DQG�\RXU�Child and must not be used by or for any other person or any other child. If you do not use this Collection Kit for the Child then you must not use this Collection Kit for any other child unless this KDV�EHHQ�VSHFLÀFDOO\�DJUHHG�ZLWK�XV�LQ�ZULWLQJ�

4. Procurement of Cord Blood4.1. It is a regulatory requirement that the procurement of Cord Blood using a Cells4Life Collection

.LW�PXVW�EH�FDUULHG�RXW�E\�DQ�DSSURSULDWHO\�TXDOLÀHG�DQG�DXWKRULVHG�SHUVRQ��)XUWKHU�GHWDLOV�relating to this can be found in Section 3 and Cells4Life is happy to advise you further on this. 3URFXUHPHQW�RI�&RUG�%ORRG�E\�D�SHUVRQ�WKDW�LV�QRW�SURSHUO\�TXDOLÀHG�DQG�DXWKRULVHG�LV�D�EUHDFK�of the Human Tissue (Quality and Safety for Human Application) Regulations 2007. Further you should be aware that the viability of the Cord Blood may be affected if it is not procured by an DSSURSULDWHO\�TXDOLÀHG�DQG�DXWKRULVHG�SHUVRQ�LQ�DFFRUGDQFH�ZLWK�RXU�8.�&RUG�%ORRG�DQG�7LVVXH�Procurement Protocol. Cells4Life reserves the right to refuse to store Cord Blood which it believes

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has not been procured in accordance with its Procurement Protocol.����� &HOOV�/LIH�GRHV�QRW�GLUHFWO\�HPSOR\�DQ\�DSSURSULDWHO\�TXDOLÀHG�DQG�DXWKRULVHG�SKOHERWRPLVWV�RU�

other personnel to procure Cord Blood samples. However, Cells4Life is able in some circumstances WR�SXW�\RX�LQ�WRXFK�ZLWK�DQ�DSSURSULDWHO\�TXDOLÀHG�DQG�DXWKRULVHG�WKLUG�SDUW\�ZLWK�ZKRP�\RX�FDQ�directly arrange procurement of the Cord Blood. Alternatively you may wish to use the Cells4Life Phlebotomy Service. Please refer to the terms and conditions for this Service as set out in Section 7.

4.3. In the event that the Cord Blood in unable to be procured you may cancel this agreement in accordance with the terms set out in Clause 11.

4.4. In the event that you decide not to proceed with the procurement of the Cord Blood you may cancel this agreement in accordance with the terms set out in Clause 11.

4.5. Once the Cord Blood has been procured, it is your responsibility to ensure that the Collection Kit LV�VLJQHG�WR�FRQÀUP�WKDW�LW�LV�\RXU�&KLOG·V�&RUG�%ORRG�FRQWDLQHG�LQ�WKH�&ROOHFWLRQ�.LW��,I�\RX�KDYH�more than one Child and have more than one Collection Kit, you must clearly identify each Child on their respective Collection Kit.

4.6. Cells4Life shall not be liable to you in any way if it is unable to process Cord Blood due to a failure by you to carry out your obligations under this Clause 4.

5. Delivery of Cord Blood to Cells4Life5.1. Once the Cord Blood has been procured, it is your responsibility to ensure that the Collection

Kit is handed directly to the courier and you must telephone Cells4Life’s twenty-four (24) hour collection line to arrange for our courier to collect your Collection Kit.

5.2. You remain responsible for the Collection Kit until our courier collects it from you and you understand that the Cord Blood must be delivered to us within forty-eight (48) hours of the birth, otherwise it may not be viable for either storage and/or future use.

5.3. Cells4Life shall not be liable to you in any way if it is unable to process Cord Blood due to a failure by you to carry out your obligation under this Clause 5.

6. Minimum volumes and sample testing6.1. If in our opinion either

6.1.1. the volume of Cord Blood collected is too small; or6.1.2. the viability of Cord Blood collected is too low to be suitable for cryopreservation of the

stem cells we will contact you to discuss your wishes regarding processing and storage of the Cord Blood. If you decide to proceed with the storage, we cannot give you any JXDUDQWHH�WKDW�WKHUH�ZLOO�EH�VXIÀFLHQW�YROXPH�LI�WKH�&RUG�%ORRG�LV�UHTXLUHG�LQ�WKH�IXWXUH�and you acknowledge this if you ask us to proceed.

6.2. There is a risk that Cord Blood can be contaminated either prior to or during the procurement process. Contamination can affect the viability and the future suitability of the Cord Blood for therapeutic use. Cells4Life will arrange for a sample of the Cord Blood to be tested for contaminants and we will notify you of the results. If requested a copy of the results can also be sent to your Child’s general medical practitioner to be placed on your Child’s medical records. Cells4Life will continue to store the Cord Blood in accordance with this Agreement even if testing has shown it to be contaminated until we receive instructions from you to dispose of the Cord Blood.

6.3. A maternal blood sample must be provided within seven (7) days of procurement of the Cord %ORRG�DQG�ZLOO�EH�WHVWHG�IRU�GLVHDVH�PDUNHUV�DV�VSHFLÀHG�E\�FXUUHQW�(&�OHJLVODWLRQ�DV�GHWDLOHG�LQ�6HFWLRQ����7KH�UHVXOWV�RI�ZKLFK�ZLOO�EH�QRWLÀHG�WR�\RX�DQG�D�FRS\�ZLOO�EH�SURYLGHG�WR�WKH�0RWKHUV·�general medical practitioner if requested by the Mother.

6.4. In order to procure, process, test, store and cryopreserve the Cord Blood Cells4Life requires your consent as evidenced by the appropriately completed and signed Statement of consent. As explained in Section 3 you may feel unable to consent to all the procedures set out in Section 3 or alternatively you may at any point withdraw your consent to some or all of these procedures. As a result Cells4Life may not be able to carry out the necessary procurement, processing and testing of the Cord Blood to enable it to be stored successfully and in accordance with the law. In this case Cells4Life will terminate the Agreement in accordance with Clause 12. Cells4Life is happy to discuss this with you further.

6.5. In the event that the Cord Blood collected is found to have been contaminated, and you acknowledge that it may not be suitable for storage or any future use you authorise us to destroy the Cord Blood. In such circumstances, this Agreement will be cancelled and we will reimburse all

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tof the fees already paid by you to us as detailed in Payment methods, excluding any Third Party Costs and the non-refundable Deposit

7. Warranties7.1. We warrant to you that the services will be provided using reasonable care and skill and,

provided that you comply with your obligations, in accordance with this Agreement.7.2. You warrant to us that:7.2.1. you are the Parent/Legal Guardian of the Child with legal responsibility for the Child;7.2.2. you have the right to enter into this Agreement on behalf of your Child; and7.2.3. entering into this Agreement does not violate any local laws or regulations, as regards

any country where the Cord Blood is being drawn.7.3. IMPORTANT – You acknowledge and accept that we cannot give any guarantees with respect to

any:7.3.1. suitability of Cord Blood for the future treatment of diseases;7.3.2. successful treatment of diseases through Cord Blood transplantation;7.3.3. advantages of Cord Blood transplantation over other types of treatment using stem

cells; or7.3.4. successful transplantation of the Cord Blood; and you enter into this Agreement with

this understanding.

8. Limit of Cells4Life’s liability IMPORTANT Subject to the terms set out in this Clause our liability to you under the Terms of this Agreement

is as follows:8.1. OUR LIABILITY TO YOU IN RESPECT OF ANY FAULT RELATING TO THE Collection Kit is limited to

the cost of replacing the Collection Kit and/or reimbursing any Storage Fee paid by you.8.2. Our liability to you in respect of ANY LOSS OR DAMAGE DUE TO OUR NEGLIGENCE, OR THE

NEGLIGENCE OF ANY OF OUR EMPLOYEES, shall be limited to DIRECT LOSSES YOU SUFFER WHICH WE COULD HAVE REASONABLY FORESEEN AT THE DATE OF THIS AGREEMENT UP TO THE MAXIMUM AMOUNT of one million pounds (£1million).

8.3. Nothing in this Agreement seeks to exclude our liability for the following:8.3.1. ANY DEATH OR PERSONAL INJURY CAUSED AS A DIRECT RESULT OF OUR NEGLIGENCE, OR

THE NEGLIGENCE OF OUR EMPLOYEES8.3.2. Fraud or fraudulent misrepresentation.

8.4. We shall in no way be liable to you for any loss or damage suffered by you as a result of your failure to comply with the terms of this Agreement.

8.5. Subject to Clauses 8.1, 8.2 and 8.3 we exclude all other liability for damage or loss suffered in connection with this Agreement whether direct or indirect to the maximum extent permitted by law.

8.6. 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.

8.7. Should there be loss of the Cord Blood whilst in the care of Cells4Life, which was beyond our control, we will reimburse a proportion of the Storage Fee prepaid (on a pro rata basis for the remaining storage term paid for).

8.8. You acknowledge that the Cord Blood collected will be divided into at least two separate portions. Both of these samples may be kept together at one location for some time until being dispatched to a second site. Therefore in the event of any loss or damage to the Cord Blood for whatever reason it may not be possible to have a “back-up” sample.

9. Fees9.1. The Storage Fee is detailed in Section 6 and is payable by you to Cells4Life in accordance with

the terms of Payment methods. The Fees are intended to cover the costs of administration, Collection Kit, testing, processing and secure storage for the relevant period as detailed therein.

����� $Q\�IXUWKHU�IHHV�ZKLFK�PD\�EH�FKDUJHDEOH�WR�\RX�ZLOO�EH�QRWLÀHG�WR�\RX�DW�WKH�WLPH��LI�applicable. This may include courier service charges which will be charged to you in theevent

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that you withdraw the Cord Blood in accordance with section 13. We may also charge for our costs incurred in transferring the Cord Blood to another service provider if you wish us to do so in accordance with section 12.

9.3. If any payment due under this Agreement remains unpaid for a period of more than 14 days after the date on which it fell due, Cells4Life shall be entitled to be paid an additional fee of £50 to cover the administration costs incurred in dealing with a late payment. For the DYRLGDQFH�RI�GRXEW�WKH�ÀJXUH�RI�����LV�D�JHQXLQH�DWWHPSW�E\�&HOOV�/LIH�WR�HVWLPDWH�WKH�FRVWV�it would incur in those circumstances.

9.4. All of our fees are quoted to include any applicable VAT.

10. Term10.1. Subject to the rights of termination set out in this Agreement the term of this Agreement shall

commence on the date Cells4Life receives this signed Agreement and the Storage Fee and shall terminate after an initial period (“the Initial Term”) of:�������� WZHQW\�ÀYH������\HDUV�IURP�WKH�&KLOG·V�ELUWK�GDWH�LQ�WKH�FDVH�RI�3UHSDLG����<HDU�6WRUDJH�

Plans; or10.1.2. ten (10) years from the Child’s birth date in the case of Annual Payment Storage Plans.

10.2. The Agreement may be continued after expiry of the Initial Term upon agreement by us and upon receipt by us of the following:10.2.1. written instructions from the Child that he or she wishes us to continue storing the Cord

Blood; and�������� SD\PHQW�RI�WKH�DSSURSULDWH�6WRUDJH�)HH�ZKLFK�VKDOO�EH�QRWLÀHG�WR�\RX�DW�WKH�WLPH�

11. Your cancellation and termination rights11.1. You may cancel this Agreement upon notifying us in writing as follows:

11.1.1. for any reason, within seven (7) working days of receiving the Collection Kit provided that you have not opened the sealed Collection Kit or used it for any purpose and you return the Collection Kit to us at your cost and in the same condition as when you received it; or

11.1.2. in the circumstances set out in Clauses 4.3 or 4.4; or11.1.3. in the circumstances set out in Clause 6.1 or 6.5; or11.1.4. in the event that:

(a) a resolution is passed or a winding up order is made for the winding up of Cells4Life; or

(b) an order is made for the appointment of an administrator; or(c) Cells4Life enters into a voluntary arrangement with any of its creditors; or

11.1.5. at any time after the expiry of the Initial Term by giving us not less than thirty (30) days’ notice.

11.2. In the event that you terminate this Agreement under Clauses 11.1.1, 11.1.2 and 11.1.3 we shall refund the Storage Fee that you have paid to us less any Third Party Costs which have been incurred.

11.3. In the event that you decide to terminate the Agreement under Clause 11.1.5 we shall refund the Storage Fee that you have paid or that is due to us under the terms of this Agreement on a pro rata basis for the balance of any storage term remaining as detailed in Section 6 less any Third Party Costs which have been incurred.

11.4. In the event that you decide to terminate the Agreement under clause 11.1.4. or 11.1.5. we shall at your written request (or that of the Child in the event that the Child is 18 or over), upon payment of all sums due to Cells4Life under this Agreement and at your cost use our reasonable endeavours to transfer the Cord Blood to an alternative storage provider of your choice, provided that transfer to such a storage provider is in compliance with applicable legislation.

12. Our cancellation and termination rights12.1. We may terminate this Agreement and stop providing the Services to you at any time in the event

that we are unable to continue to perform the services for any reason beyond our reasonable FRQWURO�LQFOXGLQJ��EXW�QRW�OLPLWHG�WR��DQ�$FW�RI�*RG��ÀUH��ÁRRG�RU�RWKHU�QDWXUDO�GLVDVWHU��ZDU��riot, insurrection or other civil commotion, strike lock-out or other industrial action, embargoes, shortage of labour, unavailability of raw materials or a change in the law. In such circumstances, we will endeavour to notify you and, if you request us to do so and if we are able to do so, we will transfer the Cord Blood to your alternative nominated storage provider at your risk and cost.

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tWe shall refund the balance of any Storage Fee you have paid on a pro rata basis for the balance of any storage term remaining as detailed in Payment methods.

12.2. We may terminate this Agreement in the circumstances set out in Clauses 4.1, 6.4. or 6.5.12.3. We may terminate this Agreement if you fail to make any payment in respect of the Storage Fee

within thirty (30) days after such payment falls due. If this Agreement is terminated in accordance with this clause 12.3 ownership of the Cord Blood will pass to us and we may then dispose of or RWKHUZLVH�GHDO�ZLWK�WKH�&RUG�%ORRG�DV�ZH�VHH�ÀW�LQFOXGLQJ��EXW�QRW�OLPLWHG�WR��DOORJHQHLF�XVH�(i.e. for use on a person other than the Child) without any further reference to you. In those circumstances clause 13 shall not apply.

12.4. We may (without limiting any other remedy available) at any time terminate this Agreement by giving notice to you if you do not comply with any of your obligations under this Agreement and (if possible) fail to resolve the issue within thirty (30) days after being required to do so.

12.5. Upon termination of this Agreement under Clause 12.2 we shall refund the Storage Fee that you have paid to us less any Third Party Costs which have been incurred.

12.6. Upon the termination of this Agreement for any reason (except where indicated that there is no requirement of further reference to you) we will, at your request, transfer the Cord Blood to another storage provider at your risk and cost. Such transfer to another storage provider will only be effected where we are legally permitted to do so and once any sums due to Cells4Life from you in respect of the Storage Fee has been paid. If you do not request the Cord Blood to be transferred to another storage provider within thirty (30) days of the termination of this Agreement, or you fail to make all due payments within thirty (30) days of termination of this Agreement, you acknowledge and agree that we may dispose of the Cord Blood at our sole discretion.

12.7. It is your responsibility to ensure that we have a current contact address for you and also for the Child once the Child has reached the age of 18. It is also your responsibility to advise the Child of any rights it may have in relation to the Cord Blood. You agree to indemnify Cells4Life against any loss or damage it may suffer as a result of failure to do this.

12.8. In the event of corporate failure the samples will be moved to an HTA licensed storage premises in accordance with the Human Tissue (Quality and Safety for Human Application) Regulations 2007.

13. Release of Cord Blood This clause 13 shall apply except where this Agreement has been terminated in accordance with

clause 12.3, in which case it will cease to be of any effect.13.1. IMPORTANT – We will only release the Cord Blood in accordance with legislation prevailing at

the time, and on the written request of you (or your Child if over eighteen (18)) and the treating medical practitioner provided that the request gives the Child’s unique reference number, or if release is required by any Court Order. We will only release the Cord Blood to a designated hospital address, or an alternative storage provider, and provided all Fees due having been paid.

13.2. IMPORTANT – We will not release the Cord Blood where to do so would contravene any law. Any notice, from you or a physician, must state the name of the individual and the address to which the Cord Blood should be delivered and the date upon which it is required. We shall arrange for our courier to deliver the Cord Blood to that address and on that date if reasonably possible. You agree that the costs of delivery are at your sole expense and we may invoice you for any such costs incurred which you agree to pay by return upon receipt.

13.3. We shall use all reasonable endeavours to deliver the Cord Blood on any requested date but you must give us as much notice as possible and you acknowledge and agree that we will not be responsible for any delays in delivery beyond our reasonable control.

13.4. The authorised person who receives the Cord Blood will be required to sign an acknowledgement RI�UHFHLSW�IRUP�WR�FRQÀUP�WKDW�WKH�&RUG�%ORRG�KDV�EHHQ�UHFHLYHG�DW�WKH�QDPHG�DGGUHVV�LQ�JRRG�order. You will be solely responsible for the Cord Blood as soon as it is delivered and you accept that we will no longer be responsible.

13.5. Permitted use13.5.1. Unless the conditions set out in paragraph 13.5.2 are complied with, Cord Blood storedunder the terms of this Agreement shall be released for autologous use only, i.e. for use directly

for the Child.13.5.2. (a) If the Cord Blood is to be used for persons other than the Child (allogeneic use

then either;(i) Polymerase Chain Reaction (PCR) testing must be repeated on the original

maternal sample prior to release, in accordance with paragraph 6.3; or

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(ii) a further maternal sample is to be provided and tested at least 180 days after birth.

(b) Should the further maternal blood sample not be collected, or not be viable for testing, the Cord Blood may not be used for allogeneic use and Cells4Life shall not be liable for any resulting loss.

13.5.3. Subject to paragraph 3 and paragraph 13.5.2(a)(ii) above Cells4Life can supply further blood Collection Kits and testing.

���� &RQÀGHQWLDOLW\�DQG�GDWD�SURWHFWLRQ������ &HOOV�/LIH�ZLOO�XVH�DOO�UHDVRQDEOH�HQGHDYRXUV�WR�NHHS�FRQÀGHQWLDO�DOO�LQIRUPDWLRQ�UHODWLQJ�WR�\RX�

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 Cells4Life will only be released if required by your or your Child’s medical SUDFWLWLRQHU�IRU�WKHLU�LQWHUQDO�FRQÀGHQWLDO�UHFRUGV�RU�RWKHUZLVH�DV�UHTXHVWHG�E\�\RX��1RQH�RI�the information held on our database will be disclosed or released to Third Parties other than as required by law.

14.2. Cells4Life 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 your 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 agree that we may disclose any such personal data to your or your Child’s medical practitioner on request or as otherwise required by law. Otherwise we will not disclose personal data to any other party without your consent. All requests must be made in writing to Cells4Life.

15. Miscellaneous15.1. You understand that this Agreement is binding upon you and your respective successors and

assigns.15.2. No variations to this Agreement shall be made unless agreed in writing by us.15.3. English law shall apply to this Agreement and the English Courts shall have the non-exclusive

jurisdiction to resolve any disputes arising out of this Agreement.15.4. If any provision of this Agreement is decided by any Court or other competent authority to

be wholly or partially invalid or unenforceable, the other provisions of this Agreement and the remainder of the provision in question shall not be affected and shall remain valid and enforceable.

������ 7KLV�$JUHHPHQW�LV�VROHO\�IRU�\RXU�EHQHÀW�DQG��FDQQRW�EH�WUDQVIHUUHG�WR�DQ\�RWKHU�SDUW\��1R�express term of this Agreement or any term implied under it is enforceable pursuant to the Contracts (Rights of Third Parties) Act 1999 by any person who is not a party to it.

15.6. If you change your address or any other details, you must promptly notify us in writing. You are responsible for ensuring that we have an up to date address for you and the Child once the Child reaches the age of 18 so that we may contact you and/or the Child if necessary.

15.7. This agreement embodies the entire agreement and understanding between us and supersedes all prior oral or written agreements, understandings or arrangements. Neither party shall be entitled to rely on any agreement, understanding or arrangement not expressly set out in this agreement save for any representation made fraudulently.

By signing this agreement, you agree that you understand and accept the above terms:

Signature of Parent or Legal Guardian

Name: ____________________________________________________________________________

Signature: ____________________________________________________________________________

Date: ______________________________________

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Section 6 - Payment methodsPayment for your chosen Service Plan is in three stages:

Stage 1 Deposit The initial deposit and full payment for the Phlebotomy Service, when selected, is payable upon booking.

Stage 2 Balance of the processing feeThe remaining balance of the processing fee is due only following the successful processing of your Child’s Cord Blood sample. This can be paid by cheque, bank transfer, credit card or debit card. For an additional fee we have a 6 or 12 month Payment Plan. Please contact our Customer Support Team for more information.

Stage 3 Storage FeePrepaid 25 Year Storage Plan The Storage Fee for this plan is also due upon successfulprocessing of your Child’s Cord Blood and must be paid for by cheque, bank transfer or cash. The UK Credit Act prohibits payment of this element by card.Annual Payment Storage Plan The Storage Fee for this plan is payable per annum (p.a.) Your ÀUVW�DQQXDO�SD\PHQW�ZLOO�EH�GXH�RQH�\HDU�IURP�WKH�GDWH�RI�WKLV�$JUHHPHQW�DQG�PXVW�EH�SDLG�E\�standing order.

Single birth

Prepaid 25 Year Storage Plan

Annual Payment Storage Plan

Platinum Service Plan 1. Initial deposit at time of booking2. Balance on successful processing3. Storage Fee on succesful processing

£ 245£1,575£ 350

£ 245£ 850£ 100

Total to pay: £2,170 £1,095

Prepaid 25 Year Storage Plan

Annual Payment Storage Plan

Premium Service Plan 1. Initial deposit at time of booking2. Balance on successful processing3. Storage Fee on successful processing

£ 195£1,150£ 350

£ 195£ 900£ 50

Total to pay: £1,695 £1,095

p.a.

p.a.

Twins special

Prepaid 25 Year Storage Plan

Annual Payment Storage Plan

Platinum Service Plan 1. Initial deposit at time of booking2. Balance on successful processing3. Storage Fee on succesful processing

£ 490£2,335£ 500

£ 490£1,100£ 200

Total to pay: £3,325 £1,590

Prepaid 25 Year Storage Plan

Annual Payment Storage Plan

Premium Service Plan 1. Initial deposit at time of booking2. Balance on successful processing3. Storage Fee on successful processing

£ 390£1,660£ 500

£ 390£1,200£ 100

Total to pay: £2,550 £1,590

p.a.

p.a.

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By cheque

Please make cheques payable to Cells4Life Group LLP and send to:Cells4Life Group LLP8QLWV������2DN�+RXVH:RRGODQGV�2IÀFH�3DUNAlbert DriveBurgess Hill RH15 9TNUnited Kingdom

By bank transfer

Account name: Cells4Life Group LLPBank: NatWest Bank PLC South Kensington Station Branch PO Box No 592 18 Cromwell Place London SW7 2LB United Kingdom

UK account number: 64907376UK sort code: 51-50-01

IBAN: GB33 NWBK 5150 0164 907376BIC: NWBK GB 2L

Reference: Mother’s last name or where known, customer number.

By card

Please note due to the UK Credit Act we are unable to accept the Storage Fee on any card.

Debit or Credit

Name on card: _____________________________________________________________

Card number: _____________________________________________________________

Valid from (mm/yy): _______________/_______________

Expires end (mm/yy): _______________/_______________

Card security code (CV2): _______________ (The rightmost 3 digit number on the signature strip)

Note: All fees and international bank charges will be payable by you, including receipt fees. American Express attracts a handling fee of 1.5%.

We accept payment by cheque, bank transfer, credit card, debit card or cash. If you are paying by cash, cheque or bank transfer please ensure the Mother’s last name of customer number, where known is provided as the payment reference.

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rmPayment PlansPlease only complete this form if you have opted for one of our Payment Plans and/or our AnnualPayment Storage Plan. If you are creating a standing order electronically, please ensure the Mother’s last name or customer number, where known, is provided as the payment reference and send proof to us.

To the bank manager

'HWDLOV� $FFRXQW�WR�EH�GHELWHG� %HQHÀFLDU\�GHWDLOV

Bank name: ______________________________________ NatWest Bank PLC

Bank address: ______________________________________ South Kensington Station Branch

______________________________________ PO Box No 592

______________________________________ 18 Cromwell Place

______________________________________ London

Postcode: ______________________________________ SW7 2LB

Sort code: ____________-____________-____________ 51-50-01

Account number: ______________________________________ 64907376

Account name: ______________________________________ Cells4Life Group LLP

Payment Plan standing order details

3D\PHQW�UHIHUHQFH��RIÀFH�XVH��� BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB

$PRXQW�RI�SD\PHQW��RIÀFH�XVH��� �BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB

$PRXQW�RI�SD\PHQW�LQ�ZRUGV��RIÀFH�XVH��� BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB

'DWH�RI�ÀUVW�SD\PHQW�� BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB

Frequency of payment: Monthly

Number of payments: Five (5) / Eleven (11)

Customer name: ________________________________________________

Customer signature: ________________________________________________

Customer contact number: ________________________________________________

Annual Payment Storage Plan standing order details

3D\PHQW�UHIHUHQFH��RIÀFH�XVH��� BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB

$PRXQW�RI�SD\PHQW��RIÀFH�XVH��� �BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB

$PRXQW�RI�SD\PHQW�LQ�ZRUGV��RIÀFH�XVH��� BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB

'DWH�RI�ÀUVW�SD\PHQW�� BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB

Frequency of payment: Yearly

Number of payments: Twenty four (24)

Customer name: ________________________________________________

Customer signature: ________________________________________________

Customer contact number: ________________________________________________

Please note banks require an original signature so scanned and printed copies can not be used.We will send the original Standing Order to your bank.

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sSection 7 - Phlebotomy Service terms & conditionsIf you have opted for our Phlebotomy Service, please read, sign and return one copy of this document to us. The other copy is for your records and should be placed with your Collection Kit.

1. Supplementary terms1.1. The terms and conditions contained in this section (“the Supplementary Terms”) are

supplemental to the terms and conditions contained in Section 5 above (“the Main Terms”).����� ,Q�WKH�HYHQW�RI�DQ\�FRQÁLFW�EHWZHHQ�WKH�0DLQ�7HUPV�DQG�WKH�6XSSOHPHQWDU\�7HUPV��WKH�0DLQ�

Terms shall prevail.1.3. The Supplementary Terms apply only to the Phlebotomy Service and their application, either

express or implied, to the Main Service or +Cord Service, as appropriate, is hereby excluded1.4. Subject to clauses 8.2, 8.3, 8.4 and 8.5 of the Main Terms, in the event of any breach by

Cells4Life in providing the Phlebotomy Service, either successfully or at all:1.4.1. Cells4Life’s liability shall be strictly limited to the cost of the Phlebotomy Service;1.4.2. such breach shall not be deemed to be a breach of the Main Terms and/or of this

Agreement generally.

2. Cells4Life’s responsibilities2.1. The Cells4Life Phlebotomy Service is provided by a partner organisation (the Phlebotomy

Service Provider). Please note that the person who attends the birth will NOT be an employee of Cells4Life.

2.2. The Phlebotomy Service Provider operates under a Third Party Agreement (TPA) for Cord Blood procurement with Cells4Life under Human Tissue Authority (HTA) License Number 11083.

����� 3URFXUHPHQW�RI�&RUG�%ORRG�ZLOO�EH�XQGHUWDNHQ�E\�D�TXDOLÀHG�SKOHERWRPLVW��VSHFLÀFDOO\�WUDLQHG�in Cord Blood procurement, who will be on call 24 hours a day.

2.4. The estimated due date, hospital location and contact details will be provided to the 3KOHERWRP\�6HUYLFH�3URYLGHU�E\�&HOOV�/LIH���7KH�3KOHERWRP\�6HUYLFH�3URYLGHU�ZLOO�FRQÀUP�WKHVH�and other pertinent details with you.

2.5. You acknowledge that in the event of medical contra-indication or where facilities are not suitable for the procurement to be undertaken, it may not be possible to procure the Cord Blood. Failure of the Phlebotomy Service in those circumstances will not be a breach of either this Agreement or the Supplemental Terms and neither the phlebotomist nor Cells4Life will carry any liability.

2.6. Phlebotomists will procure Cord Blood samples wherever your Child is delivered as long as it is safe for the mother and the Child and there are safe and suitable facilities to do so.

2.7. A maternal blood sample is also required at the time of birth. If the phlebotomist is unable to procure a maternal blood sample, arrangements will be made for a maternal blood sample to be procured within seven (7) days of birth.

3. Refund policy3.1. In the unlikely event of a problem with the procurement of Cord Blood, a full refund will be

made under the following circumstances:(i) Where the phlebotomist is refused entry to the delivery suite. (ii) Where the phlebotomist is not called and does not travel to the hospital.(iii) Where the phlebotomist or emergency out of hours service is called and it is

determined over the telephone that the call was made too late for a sample to be procured.

(iv) Where the phlebotomist is called late, unavoidably delayed or labour progresses very quickly resulting in late arrival at the hospital and coagulation of the placenta.

3.2. No Refund will be made where a phlebotomist has been in attendance at the birth and:(i) The hospital prohibits procurement for medical reasons such as post partum

haemorrhage.(ii) There is a low volume collection and/or contamination of the Cord Blood.�LLL�� 7KH�XPELOLFDO�FRUG�LV�FODPSHG�LQDSSURSULDWHO\�PDNLQJ�VDPSOLQJ�GLIÀFXOW�RU�LPSRVVLEOH�(iv) The placenta is retained and/or damaged on delivery resulting in the coagulation

and/or loss of cord blood.

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All refund requests and complaints will be subject to a thorough investigation and any decisions are at the discretion of Cells4Life.

By signing this agreement, you agree that you understand and accept the above terms:

Signature of Parent or Legal Guardian

Name: ____________________________________________________________________________

Signature: ____________________________________________________________________________

Date: ______________________________________

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sParent’s responsibilities

A simple, step-by-step process for the Phlebotomy Service is provided below for your reference.

Step 1 Notify your Midwife/Obstetrician of your desire to include Cord Blood collection in your birth SODQ���8SRQ�ERRNLQJ��D�OHWWHU�ZLOO�EH�VHQW�WR�\RX�DQG�\RXU�KRVSLWDO�WR�ÀOH�LQ�\RXU�PHGLFDO�notes notifying staff of this.

Step 2 7KH�3KOHERWRP\�6HUYLFH�3URYLGHU�ZLOO�FRQWDFW�\RX�E\�HPDLO�FRQÀUPLQJ�WKH�QDPHV�RI�\RXU�SKOHERWRPLVWV�ZKR�ZLOO�DOVR�FDOO�\RX��'XULQJ�WKLV�LQLWLDO�FRQWDFW�\RX�ZLOO�QHHG�WR�FRQÀUP�\RXU�phlebotomist’s expected travel times. This information should be noted below.

Step 3 As soon as labour starts you must contact your primary phlebotomist. In the event you are unable to make contact with your primary phlebotomist, contact your secondary phlebotomist immediately. If it is not possible to make contact with either phlebotomist, contact the Phlebotomy Service Provider using the emergency contact number provided below.

Step 4 As all labours progress at different rates you will need to keep in contact with your phlebotomist during labour. The intention is for your phlebotomist to arrive at the hospital before birth but not to attend the hospital for the duration of the labour.

Step 5 If the labour progresses quicker or slower than anticipated, your primary phlebotomist may not be able to attend the hospital in a timely manner. In such an event this may mean your secondary phlebotomist will attend instead. In rare occasions another phlebotomist may attend if this is the best option.

Step 6 If your birth plan changes (e.g. to caesarean section) you must advise your phlebotomist as soon as possible. This may occur as pregnancy progresses.

Step 7 :KHQ�WKH�SKOHERWRPLVW�OHDYHV�WR�FRPPHQFH�WKHLU�MRXUQH\�WKH\�ZLOO�FRQÀUP�WKHLU�Expected Time of Arrival (ETA). Please bear in mind journeys can result in a disruption to communication.

Step 8 If you have opted for a physiological third stage of labour you will need to request the umbilical cord is clamped to prevent exsanguination. This is stated in the letter to be placed in your medical notes that we will send you with the Collection Kit.

Step 9 Once the umbilical cord has been clamped, the phlebotomist will collect the Cord Blood and maternal blood sample. Please note the collection usually occurs in a different room to labour.

Step 10 Once the Cord Blood has been successfully collected you will need to sign your phlebotomist’s time sheet and call the courier (number on the Collection Kit box). Please keep the kit with you until it is collected by the courier.

Phlebotomists’ contact details

Primary: __________________________________ Tel: __________________________________

Secondary: __________________________________ Tel: __________________________________

Travel times

Expected travel time: _____________________________

Time of departure: _____________________________ ETA: ______________________________

Emergency 24hr phone number for the Phlebotomy Service Provider: 01444 873950

Page 36: Welcome Pack & Service Agreements

Scan this QR code with your smartphone to complete our Service Agreement online.