Terms and Conditions

Terms and Conditions for Go2Clinic Cord Blood/Tissue and Maternal Blood Collection.

By signing these Terms and conditions or by submitting the Cord Blood Collection Booking Form I fully understand and accept to be bound by these terms and conditions. This will be regarded as an agreement:

Between

1- Go2Clinic (G2C) Registration No. 12163756 at 1292 High Road, London, N20 9HJ , TeL: 020 3633 2603, Website: www.Go2Clinic.co.uk from now referred to as “G2C”.

2- The Expecting Mother from now referred to as” the client”. (or their Partner)

Service Offered from G2C: Cord Blood and/or Cord Tissue Collection and/or Maternal Blood Collection.

G2C Responsibilities

1. G2Cwill maintain adequate communication facilities such as Telephone lines and email accounts for an uninterrupted communication between itself, its staff, the Cell bank and the clients.

2. G2Cshall respond to all referrals coming from the Client or Cell bank within 24 hours of their receipt and will email the client with relevant information regarding the assignment, providing the name and contact details of two phlebotomists as well as an out-of-hour telephone number so as to ensure them of our care and dedication with 24 hour a day coverage.

3. G2Cshall provide a qualified Cord blood phlebotomist, specifically trained to collect umbilical cord blood and cord tissue to attend the birthing facility at the time of delivery.

4. G2Cwill ensure all its phlebotomist have received adequate training as required by the Human Tissue Authority for collecting a safe and successful sample of cord blood and tissue.

5. G2Cwill ensure that its phlebotomists are CRB (Criminal Record Bureau) checked and permitted to work in the United Kingdom.

6. Each client will be allocated a specific phlebotomist who will become the client’s primary contact to manage their collection and they will remain on call for them 24 hours per day until the collection has been completed.

7. The client will also be allocated a second phlebotomist who will act as a backup should there be any problems with their primary phlebotomist on the day of the collection.

8. G2Cwill ensure that its personnel adhere to the current version of the Cell bank standard Operating Procedure for Collection of Cord Blood.

9. G2Cshall be responsible for the identification of the specific blood unit by signing the Cord Blood procurement Form, contained within the kit.

10. G2Cshall be responsible for ensuring that the suitable conditions are available for collection before proceeding i.e. a suitable birthing room.

11. The primary consideration at child birth is the safety of the mother and the baby. G2Cacknowledges that the prime responsibility of the attending midwife or doctor is to the above consideration and undertakes that its personnel shall at no time engage in any action hereunder that distracts medical attention from this task.

12. In recognition of the importance of the above consideration cord blood may only be collected provided that approval has been granted by the attending obstetrician or mid-wife.

13. When on site, the G2Cphlebotomist will do their best to collect a sample of umbilical cord blood and if required, a sample of umbilical cord tissue.

14. The phlebotomist will also take a sample of maternal blood on the day of the delivery.

15. G2Cwill email the Cell bank a full collection report normally within 24 hours of each completed collection. Reports will be emailed or given verbally on the phone to the Cell bank for Serious Adverse Events (SAEs) immediately and a full written report will follow within 24 hours.

16. When communicating with clients, G2Cphlebotomists will not comment on the quality or quantity of the sample they have procured and leave that to the labs.

17. G2Cwill record the client’s personal details including their expected date of delivery, their location and contact details. This personal information will be stored in accordance with the Data Protection Act 1998.

18. All phlebotomists will carry a G2Cidentification badge and a copy of the relevant Third Party Agreement (TPA) with the Cell bank.

19. Our phlebotomists have been trained to carry out a risk assessment test to ascertain the suitability of the place prior to their procurement. Our Phlebotomist will do a Risk Assessment on every home birth collection they receive.

20. G2Cupholds a zero tolerance policy towards any abuse from the client and will withdraw services without refund immediately.

21. No liability is accepted by G2Cin the following situations: – The cell count in the blood collected is below the cut-off point for routine storage or below the cut-off where the Cell bank recommends non-storage – Contamination of the blood collected – Failure or inability of the G2Cto collect blood for any reason related to the care of the mother or baby – Any loss due to damage to the cord blood unit due to problems with transport – Any liability arising out of use of consumables not supplied by the Cell bank. – Any acts or omissions of the attending midwife or doctor – The provision of the services herein by G2Cimplies no recommendation by G2Cas to the clinical use of any cord blood unit collected. – G2Caccepts no liability for the failure of any such cord blood unit in relation to future transplant technology. – Other potential Issue with the Collection: Occasionally there are certain circumstances which may prevent the collection from taking place. These can include the following:- a. When the client has withdrawn consent. b. Where the placentas and/or umbilical cord is damaged during the delivery. Under such circumstances G2Cphlebotomist will collect the cord tissue when possible and if required. c. Where the parents have not provided the relevant collection kit. d. Where parents have been too late in contacting the phlebotomist resulting in delays to the phlebotomist attending site. e. Where for any reason the phlebotomist is refused entry to the maternity unit of the hospital.

22. G2Cshall embody its procedures for quality, recruitment, training of staff, and operations in an internal set of procedures. The Cell bank shall have the right to audit the documentation and operations of G2Cwithin 5 working days of a request specifically in relation to cord blood collected for the Cell bank clients. Such right of auditable access shall extend to any successor organisation of Cell bank or any organisation which undertakes to continue the ongoing obligations of the Cell bank in the event that the Cell bank ceases to trade.

23. In line with regulation, G2Chereby agrees to hold all customer data, including identity, medical records and other data as confidential and shall not disclose it to any other party except the Cell bank and shall ensure that all their staff is bound by this obligation of confidentiality. The obligations of confidentiality herein extend beyond the termination of the working relationship between the Cell bank and G2C.

24. All records held by G2Cshall meet the confidentiality requirements laid down in the Human Tissue Authority (HTA) Regulations, as amended from time to time.

25. G2Cwill invoice the client for the collections in advance and payments for any selected services among options 1,2,3,4,65,6 or 7. This invoice must be paid in full before the allocation of phlebotomists. Options 3 and 4 are for the collections in Scotland, Wales and/or Northern Ireland. Option 5 is not available in Scotland, Wales and/or Northern Ireland..

26. Unlimited time has a maximum cap of 14 hours. In the unlikely event when the phlebotomist is required to stay longer than 14 hours at the hospital or in case of home birth at client’s home, the client will have to pay £25 per hour for extra time.

27. Option 1 and 3 will be charged at the rate of £375.00 and £400.00 respectively, this amount will cover collections up to 8 hours (i.e. the time spent on-site with the client). Any extra hours beyond 8 hours will be charged at £25 per hour.

28. When in options 2 and 4, 14 hours is passed, or when in option 1 and 3, 8 hours is passed, the client must sign the timesheet of the phlebotomist to confirm the (extra) time that the phlebotomist has spent at their service.

29. For any of the options including the unlimited options, G2Cwill not send phlebotomists to attend the hospitals or birthing units too early. For first babies phlebotomists are expected to attend when cervical dilation has reached 8 cm. For second, third, etc babies the phlebotomists will attend the hospital when the cervix is 6 cm dilated. This is a rough guide of when to send the phlebotomist and may not be applied at all times. If earlier attendance is required G2Coffice should be notified in advance in writing (by emailing Stemcells@Go2Clinic.co.uk or calling 020 3633 2603). If a phlebotomist is called in too early, the client will be liable to pay any extra waiting time from the moment the phlebotomist arrives on site until the time when the phlebotomist should have been called in. i.e. if phlebotomist was called in for a first baby when client was 5 cm dilated. the amount of time that the client will take to reach 8 cm of cervical dilation (from 5cm to 8cm) must be paid by the client at a rate of £25 per hour. For second(+) babies, if the phlebotomist is called in too early without prior arrangement , any extra time spent from the moment the phlebotomist arrives on site until the client’s cervix is 6cm must be paid at the rate of £25 per hour.

30. If any fee remains to be paid by the client, G2Cshall invoice the client for payment and the client agrees to pay G2Cin full within 2 weeks.

31. After the completion of Cord blood/tissue and maternal blood collection, the client must call the courier to arrange the pick up of the kit and its transport to the lab. details of the courier is usually provided by the relevant cell bank. G2Chas no responsibility to arrange a pick up or to carry the collection kit to the Lab.

32. Our Phlebotomists are not responsible for arranging couriers to transfer the collected samples to the labs.

The Client Responsibilities

33. The HTA Regulations require the Cell bank and procurement agents to obtain a license or to act under the authority of a licence holder through a third party agreement (TPA) which embodies the requirements of HTA Directions 002/2007 Paragraph 14. To comply with the HTA requirements in this field, The Cell bank in which the client wishes to store their tissues with must be Licensed with a HTA licence otherwise G2C will reject to undertake any collections for the client. The Cell Bank must therefore sign a TPA with G2C if they are to benefit from G2C Cord blood/tissue collection services.

34. The Client should send G2C their name and contact details, their due date or date of having a C-Section or Induction, the name and location of hospital/home where birth will be taking place and any other special requests. This information should be sent to G2C either in the form an email to: stemcells@Go2Clinic.co.uk or by phone to 020 3633 2603

35. The Client must inform the G2C of any changes to the above information as soon as they learn it from the clients.

36. One day notice is desirable for the referrals unless when it is an emergency when no notice is required to utilise G2C services.

37. The Client hereby gives consent to G2C to collect their blood and/or the cord tissue based on the services they require such as cord blood collection, cord tissue collection and maternal blood collection.

38. The Client will make sure that the Cell bank will provide an un-expired complete collection kit to the client.

39. The client is to bring the kit with them to the birthing facility on the day of delivery of their baby. The Kit must include all the collection equipment, relevant paperwork and documents and unexpired materials needed for a safe and HTA approved standard collection of : – Cord blood – Cord Tissue (if opted by the client) – Maternal Blood . The content of the kit must include the following: – At least one un-opened sterile blood bag pre-filled with Anticoagulant solution to prevent the Cord blood sample from coagulating in transport to the Cell Bank labs. – Some form of Antiseptic wipes or solutions such as chlorhexidine for disinfecting insertion sites on the cord and placenta. – At least one pair of gloves. (optional) – If collection of Cord tissue is required, a canister or container for the cord is required with a solution such as saline to keep it moist while in transport to the labs. A pair of scissors for cutting the cord. – Blood tubes (e.g. vacutainer) necessary for collection of maternal blood sample as well as a vacutainer Holder and needle. – Jiffy bags, plastic bags or Gel packs for maintaining a temperature controlled transportation of the samples collected to the labs. A piece of absorbent material for packing it with the cord blood bag and one for the cord tissue sample. – Cord blood/tissue procurement forms and maternal blood collection form – If the blood bags and cord tissue container and maternal blood tubes are found to be unlabelled, or un-bar-coded, separate label s should be included in the kit for sticking them onto the samples after the collection. If no separate labels are provided, client’s unique kit number and date of birth should be provided so our phlebotomist could write them on the samples for identifications.

40. The Client will make sure that the Cell bank provides a point of contact reachable 24 hours a day to G2C and its staff for advice at all times especially during collections when a Serious Adverse Event (SAE) might be in place.

41. The transport of the kit to the Cell Bank’s Labs after cord blood collection has been done must be liaised between the client and the Cell bank. G2Chas no responsibility to carry the collection kit to the Lab.

42. G2C invoices must be paid within two weeks after their receipt by the Client when there is any outstanding charge after the collection is completed.

43. All cheques must be made payable to Go2Clinic or G2C.