TERMS AND CONDITIONS
Terms and Conditions and Informed Consent for the Collection, Processing and Storage for Umbilical Cord Blood and Tissue Storage
1. Interpretation and deﬁnitions
The following terms shall bear the following meaning:
1.1. “Agreement” means these terms and conditions as attached to the Client Registration Documentation, including the Informed Consent and such terms and conditions on the CryoSave website which relate hereto;
1.2. “Child” means the Child who is born and from whose umbilical cord the Umbilical Cord Blood (UCB) and/or Umbilical Cord Tissue (UCT) Stem Cells are collected;
1.3. “Client” means the Mother and/or the Father subject to, in the event:-
1.3.1. where the Mother is deceased, the Father of the Child shall automatically be deemed from the date immediately prior to the death of the Mother, to be the Client; or
1.3.2. where the Mother and Father of the Child are deceased, the legal guardian of the Child with effect from the date immediately prior to the date of the last deceased; or
1.3.3. where the Child attains the age of majority, the Child shall be the Client with effect from the date of attainment;
1.4. “Client Registration Documentation” means the CryoSave Client Registration Documentation required to be completed by the Client in order to register with CryoSave.
1.5. “CryoSave” means CryoSave South Africa (Pty) Limited (Registration Number 2010/009754/07), and its respective shareholders, directors. CryoSave is a company duly registered and incorporated according to the company laws of the Republic of South Africa;
1.6. “Father” means the:
1.6.1. biological father (conceived the Child); or
1.6.2. biological father (donated the sperm in respect of the Child); or
1.6.3. legal father (legal guardian of the Child);
1.7. “Informed Consent” means the informed consent that is required to be signed by the Client in terms of statute;
1.8. “Maternal Blood” means the blood to be taken from the birth Mother at birth and to be tested for transmissible diseases and/or any other factors as required in accordance with legislation and international standards;
1.9. “Healthcare Practitioner” means inter alia, an obstetrician, midwife or nurse;
1.10. “Mother” means the:
1.10.1. birth mother (gave birth to the Child); or
1.10.2. biological mother (donated the egg); or
1.10.3. legal mother (legal guardian of the Child).
1.11. “Processing/Process” means all operations involved in the preparation, isolation, extraction, and cryopreservation of the Stem Cells from the UCB and/or UCT;
1.12. “Stem Cells” mean cells that have the capability of differentiating into specialised cells of the body and producing daughter stem cells (i.e. capable of self-renewal);
1.13 “Expansion” means a method to increase the number of stem cells outside the body (ex vivo) prior to clinical use.
1.14. “Storage/Storing/Store” means maintaining the Stem Cells under appropriate controlled conditions;
1.15. “Storage Period” means 20 (twenty) years.
1.16. “Testing/Test” means (subject to the context of use of such term), maternal blood tests performed on the biological Mother for transmissible diseases, and/or laboratory tests conducted on UCB and/or UCT;
1.17. “UCB” means umbilical cord blood which contains haematopoietic (blood-forming) stem cells
1.18. “UCT” means umbilical cord tissue which contains Mesenchymal (tissue-forming) stem cells
1.19. “The Laboratory” means the CryoSave South Africa Laboratory
1.20. Any reference to an enactment, regulation, rule or by-law is that enactment, regulation, rule or by-law as at the signature date, and as amended from time to time.
1.21. All amounts payable in terms of this Agreement are inclusive of VAT unless otherwise indicated.
1.22. This Agreement shall be governed by the laws of the Republic of South Africa.
2.1. This is an Agreement between CryoSave and the Client relating to the collection of UCB and/or UCT obtained from the umbilical cord of the Child, with the view to cryogenically store the extracted UCB and/or the UCT with CryoSave, private cryogenic storage laboratory.
2.2. The Client has requested and consented to the Collection, Processing, Testing and Storage of Stem Cells obtained from UCB and/or UCT collected from the umbilical cord at the time of the birth of the Child.
2.3. The Client intends to store the Stem Cells acquired from the UCB and/ or UCT, for the sole and exclusive benefit of the Child or any such family member that the Client expressly and in writing elects to donate the Stem Cells, if there is a suitable tissue match.
2.4. The Client authorises CryoSave to Process, Test and Store such Stem Cells in terms of this Agreement and according to the agreed upon Informed Consent.
Subject to the order of any court of competent jurisdiction, and to the terms and conditions of this Agreement, all right, title and interest in and to the UCB and/or UCT and Stem Cells derived therefrom shall, vest exclusively with the Client. All such right, title and interest shall cede to the Child, at the date at which the Child attains the age of majority (in terms of the Children’s Act, 38 of 2005 as amended.
3. Collection, transport, processing and storage of umbilical cord blood and/or umbilical cord tissue
3.1. The Client undertakes to:
3.1.1. consult with CryoSave, and make the necessary arrangements to ensure that UCB and/or UCT is collected and properly packaged in the kit, in accordance with the instructions provided therein;
3.1.2. contact CryoSave within 1 (one) hour of birth of the Child, or as soon as reasonably possible after the collection of the UCB and/or UCT, to ensure that a reasonable time is afforded to CryoSave to arrange for a courier to transport the UCB and/or UCT to the CryoSave laboratory.
3.2. CryoSave shall not be responsible for any compromise to the integrity of the UCB and/or UCT before, during or after collection or transportation (which is beyond the control of CryoSave).
3.3. CryoSave shall Process the UCB and/or UCT and Store the Stem Cells, provided that it reserves the right to refuse to Process and Store the UCB and/or UCT if the UCB and/or UCT was incorrectly collected and/or deposited, and/or contaminated and/or the collection volume falls below the minimum requirements, and/or if any tests or reports on the Mother are deemed unfavourable, and/or the requisite Informed Consent has not been completed and/or not been signed, and/or the collection fee or processing fee has not been paid, and/or testing of the UCB and/or UCT is deemed to be Sub-Optimal, and/or once Processed, the number and/or viability of the Stem Cells falls below the minimal requirements as defined by CryoSave as being suitable for Storage:
3.3.1. Optimal (a UCB and/or UCT that contains stem cells that have been extracted from either the UCB, UCT (or either of or both) and which CryoSave has determined as being suitable for storage); (refer to 5.1.1)
3.3.2. Sub-Optimal (a UCB and/or UCT that notwithstanding that it contains stem cells that have been extracted from either the UCB and/or, UCT which, in the opinion of CryoSave (due to factors that may include, but not be limited to the number or quality of the stem cells contained therein) the future potential usefulness of such cells is in doubt and in respect to which the election to store such is left to the Client in accordance with clause 5.1.2; or
3.3.3. Not Viable (a UCB and/or UCT that, irrespective as to whether such UCB and/or UCT contain any stem cells or not, in the discretion of CryoSave as per clause 5.1.3, has been rejected for storage.)
3.4. In the case of a multiple birth, CryoSave will only be providing services in regard to one UCB and/or UCT, unless CryoSave and the Client have agreed to the provision of services in respect to more or all of the born children, in which event a Multiple Birth Agreement shall be applicable and completed.
3.5. CryoSave shall Store the Stem Cells in good condition for the Storage Period, or such other continued period of Storage as agreed between the Client and CryoSave from time to time.
3.6. CryoSave undertakes to contact the Client, 4 (four) months prior to the expiration of the Storage Period, and the Client will have the option to elect to:
3.6.1. continue Storing the Stem Cells, in which case CryoSave shall invoice the Client for the Storage thereof at the current rates, which will be market related; or
3.6.2. terminate this Agreement in accordance with clause 10.1;
3.6.3. If, CryoSave elects to terminate the Agreement in accordance with clause 10.1, all rights in and to the UCB and/or UCT shall be deemed to have been waived in favour of CryoSave and CryoSave shall have the right to dispose of the UCB and/or UCT.
3.7. The Client (or Child obtaining the age of majority), in consultation with a Healthcare Practitioner who by qualification is authorised to release the UCB and/or UCT and/or administer a Stem Cell transplant, may elect to retrieve the Stem Cells from Storage, in accordance with clause 4, as and when deemed necessary.
3.8. CryoSave shall be entitled to transfer the stored Stem Cells to an authorised organisation, institution or person (authorised in terms of the South African National Health Act 2003, Regulation 183 on Stem Cells Banks to conduct the activities referred to in paragraph 2 Regulation 183 – (and which is amended from time to time) or any other internationally accredited establishment, or relocate its storage facility at any time and furnish the Client with written notice thereof.
3.9. In the unlikely event that CryoSave ceases to continue trading for whatever reason, CryoSave has contracted its obligations in terms hereof out to an authorised organisation, institution or person, who will ensure the ongoing storage of the stem cells in terms of this Agreement.
4. Retrieval, preparation and transfer for transplant or other reason
Should the Client wish to retrieve the stored Stem Cells, the Client shall provide CryoSave with a minimum of 30 (thirty) calendar days written notice of the intended retrieval date
4.2 Any retrieval shall be done in accordance with CryoSave’s policy and/or international standards for such, as may be amended from time to time. The release of UCT or UCT stem cells will only be to an approved Transplant facility at the request of a Transplant physician.
4.3 When a cord blood sample is required by a Client for a cord blood stem cell transplant, CryoSave will at no cost to the Client provide the following services:
4.3.1 Viable testing on the cord blood pre-transplantation that are directly, required in relation to the transplant;
4.3.2 Shipping costs of the released cord blood sample, from SA to anywhere in the world to ensure the transport of the sample in a manner that is reasonable and appropriate to transport the sample.
5. General notiﬁcations
5.1. Once the Tests have been concluded and/or the Stem Cells cryopreserved and Stored, CryoSave shall notify the Client in writing whether:
5.1.1. the Stem Cells are suitable for Storage, in which case they will be Stored in terms of this Agreement; or
5.1.2. the Stem Cells are Sub-Optimal, in which case the Client has the option to elect to:
220.127.116.11. continue Storage of the Stem Cells; or
18.104.22.168. destroy the Stem Cells; or
22.214.171.124. donate the Stem Cells for Research and Development purposes.
5.1.3. the UCB Stem Cells fail to meet the CryoSave storage limit requirements, in which case the Client will have the option to destroy the Stem Cells.
5.1.4. in the event of a transplant, the number of stem cells in the cord blood collection is a predictor of successful engraftment. I accept that CryoSave will continue to store cord blood units that have a relatively low number of stem cells on the basis that technology exists to increase the number of stem cells (‘expand’ the number of cells) prior to transplant – although the technology to expand and the ability to use expanded cells clinically is not currently available in South Africa. The expansion of stem cells will incur additional costs (that are not part of this contract).
5.2. In each of 5.1.2 and 5.1.3, the Client’s express written authorisation will be obtained.
5.3. The results of the Maternal Blood Tests will be made available to the birth Mother upon request.
6. Warranties and limitation of liability
6.1 Client acknowledges that CryoSave has not made nor does not make any representations or warranties to the Client, whether express or implied, of any kind or nature, including, without limitation of the foregoing, any warranties with respect to:
6.1.1 the suitability of the UCB and/or UCT or Stem Cells for the future treatment of any disease, illness, injury or other medical affliction;
6.1.2 the advantages of transplanting Stem Cells derived from UCB and/ or UCTs over other types of treatment using Stem Cells derived elsewhere.
6.1.3 medical advice or provide any services other than those described in this Agreement.
6.2 Notwithstanding anything that may be construed to the contrary herein, CryoSave’s maximum amount of any and all liability to the Client in terms of this Agreement or with respect to any and all actions or omissions of CryoSave, or such other persons, under any and all circumstances shall be the total amount paid by the Client to CryoSave.
6.3 The Client further acknowledges that CryoSave is not responsible for the actions of others, including healthcare practitioners, nurses, midwives, the birthing hospital or medical facility, hospital or medical facility staff and couriers and transporters of the UCB and/or UCT and Stem Cells.
6.4 CryoSave shall not be liable to the Client or any other third party for any direct, indirect, special, punitive, consequential or incidental damages or losses.
6.5 CryoSave shall not be held liable for any loss or damage to the UCB and/ or UCT or Stem Cells derived therefrom caused by any event beyond its control and/or which is considered to be a force majeure event.
6.6 CryoSave shall also not be liable for any damages due to destruction of the UCB and/or UCT following cancellation of this Agreement.
7. Fees and payment
7.1. The Client acknowledges that collectively the Mother, Father and the Child are jointly and severally liable under this Agreement, for any and all amounts owing to CryoSave in terms hereof.
7.2. The Client acknowledges that in accordance with the Client Registration Documentation and subject to the further provisions of this Agreement. For purposes hereof, successful storage has occurred if CryoSave has Stored any Optimal or Sub-Optimal Stem Cells (at the election of the Client) for the use (or potential use) and benefit of the Client.
7.3. The total cost of this service is set out in the Client Registration Documentation and which is to be paid by the Client in full on signing of the contract as per the accepted quote in Appendix A:
7.3.1. The Storage Fee (as per the accepted quotation) shall be due and payable once the Client has received notification of Storage of the UCB and/or UCT on an annual basis.
7.4. All overdue amounts shall bear interest at a rate equivalent to the aggregate of the publicly quoted prime overdraft lending rate charged by CryoSave’s bankers plus 2% (two percent).
7.5. The Client acknowledges that any failure to effect payment of any fee or cost timeously may result in the cancellation of this Agreement by CryoSave, after written notice to the Client, which cancellation shall not limit CryoSave’s rights in terms hereof, common law or otherwise.
7.6. Should CryoSave institute legal action against the Client for recovery of any outstanding fees, the Client shall be liable to CryoSave for any and all legal costs, including attorney and own client costs, collection fees and tracing fees.
7.7. Where no storage of Sub-Optimal Stem Cells has occurred, no fee in respect of Storage will be payable by the Client.
7.8. Where Storage of any UCB and/or UCT has occurred, an annual storage fee is charged to cover the escalation of CryoSave’s costs over the twenty year period. Payment hereof shall be made by means of a debit order in favour of CryoSave that shall become due on the anniversary of the Child’s birth month of each successive year. An unpaid debit order necessitates representation at my/our bank for payment which will be no more than 7 day(s) after the initial failed transaction and a maximum of 5 day(s) tracking will be applicable. Should this payment fail, I/we will make an arrangement for payment.
7.9. Failure of the debit order payment will result in the client to pay the amount within 7 days
7.10. The above-mentioned fee may, at the discretion of CryoSave escalate annually broadly consistent with the consumer price index.
7.11. The partial or total withdrawal and/or retrieval of the UCB and/or UCT by the Client (irrespective of the reason for withdrawal) shall not entitle the Client to a refund of any fees paid or make him not liable for payment of any fees still due and payable at such time.
8. Client’s undertakings
8.1. The Client undertakes to specifically ensure that all required consents and Testing of the UCB and/or UCT and/or the birth Mother for any infectious diseases, which may include but not limited to HIV, Hepatitis B and Hepatitis C, is done at the time of birth of the Child.
8.2. The above tests and any further as may be required in terms of legislation or international standards, requested by CryoSave under this Agreement will be done at a registered pathology laboratory specified by CryoSave and the Client hereby unconditionally consents to the Tests and gives permission to CryoSave to collect and obtain the Test results.
8.3. The Client undertakes to, at the request of CryoSave ensure:
8.3.1. that any further, or additional medical or blood tests of the mother of the Child, that CryoSave may require to be done before birth or at any time thereafter, is done (at their cost); and
8.3.2. to complete such forms, and supply such information as requested by CryoSave from time to time
8.4. The Client acknowledges that any failure to adhere to the above request may result in CryoSave being unable to confirm/continue Storage of UCB and/or UCT.
8.5. The Client undertakes to provide CryoSave with complete and accurate information in writing concerning contact information of the Client and the Child required by CryoSave, for the duration of the Agreement. The Client also agrees to provide such other information that CryoSave may require for the Testing of the UCB and/or UCT, Maternal Blood, performance of its services, compliance with the laws, regulations, permits and certifications, as well as for the proper identification of the Client and the Child.
8.6. If any information that the Client has provided to CryoSave changes or is no longer valid, the Client acknowledges that it is his/her/their responsibility to advise CryoSave promptly of all such changes or invalidity.
8.7. CryoSave will use all reasonable endeavours to keep confidential all information relating to the Client and/or Child. Personal information will only be held in CryoSave’s hardcopy files in a locked location and on secure electronic database and back-up files.
8.8. Information will only be released to the Client and/or Child’s Healthcare Practitioner for their internal confidential records or otherwise as requested by the Client and/or Child.
8.9. By signing this Agreement, the Client consents to CryoSave holding the Client and/or Child’s personal data for the purposes of performing CryoSave’s obligations under this Agreement.
8.10. CryoSave may from time to time send out electronic information by email or SMS to the Client, to update the Client on developments regarding CryoSave and the stem cell industry in general. The Client may at any time opt out from receiving this communication.
9. Cession and assignment
9.1. Transfer the location of the processing laboratory; and/or;
9.2. Transfer the Storage Facility, and/or;
9.3. cede and assign its rights and obligations under this Agreement to a third party and furnish the client with written notice thereof.
The Client may, in writing, transfer to one or more persons his rights under this Agreement at any time. No transfer shall take effect until the transferee or successor consents in writing to the transfer and agrees to be bound by this Agreement. Should the Client be deceased or disabled and should there be no transferee or successor to the Client’s rights, CryoSave may, in its entire discretion, recognise the authority of any person to represent the Client.
10. Termination, cancellation and breach
10.1 CryoSave reserves the right to terminate this Agreement in the following circumstances:
10.1.1. failure of the Client to provide the UCB and/or UCT, and/or the Maternal Bloods and/or the information that CryoSave requires for the performance of its services or compliance with this Agreement, the law, regulations or accreditation.
10.1.2. receipt of the results of the Tests, and according to CryoSave’s internal quality and accreditation requirements or the relevant government regulations or statute, indicating that the UCB and/or UCT is not viable for storage.
10.1.3. should the UCB and/or UCT yield insufficient Stem Cells, then no Storage shall take place, and accordingly, the Client shall incur no liability in regard to the Storage Fee;
10.1.4. in the event that the payment due has not been received within 7 (seven) calendar days after the date of written notification to the Client to effect payment;
10.1.5. in the event of the Client not responding within 6 (six) months after the expiration date of the Storage Period, despite CryoSave having notified the Client at least twice, within 6 (six) months prior to the date of expiration and once within the 6 (six) months after expiration.
10.2. The Client may terminate this Agreement at any time upon written notice to CryoSave, provided all associated costs and fees are settled in full.
10.3. On termination, the Client can elect that stored Stem Cells are:
10.3.1. transferred to an alternative Storage Facility (once all outstanding fees have been paid, including the shipping or courier fees); or
10.3.2. destroyed; or
10.3.3. donated for quality control or research purposes; or
10.3.4. donated to a public bank/registry.
10.3.5. If no election has been made, then the Stem Cells will be destroyed.
10.4. Notwithstanding the foregoing, this Agreement, along with all further liabilities with regard to annual Storage fees, will be terminated on withdrawal by the Client of all the Stored UCB and UCT.
11. Domicile and notices
11.1. The Client shall appoint an address for receiving communication during the Storage Period and shall be responsible for immediately advising CryoSave in writing of any changes.
11.2. CryoSave chooses as its address for the receipt of all notices: P.O. Box 39660, Garsfontein East, 0060, Pretoria, Republic of South Africa; alternatively, E-mail: firstname.lastname@example.org.
11.3. Either party shall be entitled to vary the addresses set out above on written notice to the other.
11.4. Notices may be sent by e-mail, fax or air post. E-mail and fax shall be deemed to have been received on the day following transmission and if sent by air post, on the tenth day after posting, provided that any change of address sent to CryoSave shall only be deemed to have been received after written acknowledgement is sent to the Client.
12.1 Any dispute, other than where an interdict is sought, arising out of or pursuant to this Agreement shall be addressed in accordance with the rules and processes of the Arbitration Foundation of Southern Africa.
12.2 This Agreement, the appendices and other information emailed to the Client, constitutes the entire Agreement between the parties.
12.3 No agreement varying, adding to, deleting from or cancelling this Agreement shall be effective unless reduced to writing and signed by or on behalf of the parties.
12.4 No indulgence granted by a party shall constitute a waiver of any of that party’s rights under this Agreement.
12.5 This Agreement may be signed by the parties in counterparts.
13. Guardian (if applicable):
13.1 If the biological mother is under the age of 18 years, it is a requirement that one of the mother’s parents (or legal guardian) also sign this Informed Consent Form.
13.2 Should you or the biological mother have any questions relating to the content of the Form, please feel free to discuss it with the attending Healthcare Practitioner, or with the laboratory Medical Director.
14. Protection of private information
14.1 CryoSave is obligated to protect personal information of clients, legally and ethically, at all times. I thus understand that no personal information will be disseminated to any third party without my express, written and informed consent in accordance with the provisions of the Protection of Personal Information Act, No. 4 of 2013 and the National Health Act No. 62 of 2003.
14.2 I acknowledge that once my personal information is passed on to a third party by CryoSave with my consent, whether on the basis of a referral to another service provider or for the purposes of institution of legal action, the information thereafter falls outside the control of CryoSave.
14.3 I also acknowledge that the capture and storage of my personal information by CryoSave is necessary to ensure an updated and complete medical record related to my medical history in order for accurate evaluation and determinations to be made with the appropriate conclusion at any time, either by CryoSave or another service provider or legal practitioner, where and if applicable.
14.4 My contact details are only for the purposes of the records of CryoSave and if applicable, the institution of future legal process in the event of my default or failure to ensure due and timely payment – unless otherwise stated with my consent.
14.5 My record remains the property of CryoSave and which is legally required to be retained by CryoSave for periods as stipulated by existing legislation. Clients are entitled to obtain details contained within such records, if so requested.
15. Electronic Communication
15.1 The Client acknowledges that this agreement does not infringe any provision of the Electronic Communications and Transactions Act, No. 25 of 2002.
15.2 This agreement shall constitute a valid and binding agreement in accordance with Section 22 of the Electronic Communications and Transactions Act, No. 25 of 2002. No written confirmation or reciprocal signature by the Client and/or CryoSave is required to give effect to the rights and obligations established by the agreement.
16. INFORMED CONSENT
Consent is mandatory prior to processing of any UCB or UCT samples
1. Conﬁrmation of comprehension
The Client hereby confirms that I/we/they understand that this INFORMED CONSENT is a mandatory requirement in terms of the Health Act N0. 61 of 2003, in order to authorise the umbilical cord blood (UCB) and/or umbilical cord tissue (UCT) collection and associated testing, processing, cryopreservation and storage.
2. Collection, processing, testing and storage of cord blood and cord tissue stem cells
2.1 The decision as to whether to perform the Umbilical Cord Blood (UCB) and/or Umbilical Cord Tissue (UCT) collection is subject to the medical opinion of the chosen Healthcare Practitioner and CryoSave has no control over the opinion and/or recommendations made by the Healthcare Practitioner in this regard.
2.2 CryoSave ultimately has no control of the actual collection performed by the Client’s chosen Healthcare Practitioner and the Client assumes full risk for the collection.
2.3 This consent does not necessarily force the Healthcare Practitioner to perform UCB and/or UCT collection if it is considered that the circumstances at the time of birth are not appropriate.
2.4 I have the right to refuse collection at any time without prejudice, even after signing this Informed Consent.
2.5 Cord blood collection methods are in-utero and/or ex-utero
2.6 Delayed clamping of the cord, which may be deemed necessary by the attending Healthcare Practitioner, may significantly reduce the quantity of blood collected and the number of stem cells in the collection, thereby significantly reducing the likelihood that the collection will be suitable for transplant.
2.7 Cord blood
2.7.1 Umbilical cord blood transplantation (haematopoietic stem cell transplantation) is an established medical procedure. The future therapeutic use of the Child’s UCB may entail risks and benefits that are as yet unknown. The Client shall at the appropriate time, together with the treating Healthcare Practitioner, make decisions regarding the use of the UCB and the benefits, risks and costs of this particular treatment.
2.7.2 In the event of a transplant, the number of stem cells in the cord blood collection is a predictor of successful engraftment.
2.7.3 I accept that CryoSave will continue to store cord blood units that have a relatively low number of stem cells on the basis that technology exists to increase the number of stem cells (‘expand’ the number of cells) prior to transplant. The ability to use expanded cells clinically is however not currently available in South Africa. The expansion of stem Cells will incur additional costs (that are not part of this contract).
2.7.4 There are alternative sources of blood stem cells such as bone marrow and peripheral blood.
2.8 Cord tissue
2.8.1 The clinical uses of cord tissue stem cells (mesenchymal stem cells) are still experimental and are currently only being used in ethically approved clinical trials.
2.8.2 Mesenchymal Stem cells that are collected from the Child’s UCT may assist in the treatment of future disease, but such assistance or suitability cannot be guaranteed.
2.8.3 The future therapeutic use of mesenchymal stem cells may entail risks, benefits and costs that are as yet unknown. The Client shall at the appropriate time, together with the treating Healthcare Practitioner, make decisions regarding the use of the mesenchymal stem cells and the inherent benefits and risks of this particular treatment.
2.8.4 There are alternative sources of mesenchymal stem cells such as bone marrow and adipose tissue validation testing.
2.8.5 Transfer of the cord blood and tissue stem cells to another facility upon request or in extreme cases where the integrity of the stem cells depend on it.
2.8.6 I/we agree to provide information related to my/our medical and genetic history.
2.8.7 CryoSave will perform tests on the Child’s UCB and UCT and, if it considered necessary, may require additional tests to be performed on the maternal blood and/or blood of the child.
2.9.1 The storage of the UCB and/or UCT may be unsuccessful for several reasons, which shall include, but not be limited to the following:
2.9.2 the Healthcare Practitioner may be unable to perform the collection;
2.9.3 it may not be possible to collect a sufficient quantity of UCB and/or UCT for processing and storage;
2.9.4 after arrival at the laboratory, the UCB and/or UCT may be found to be unsuitable for storage;
2.9.5 the UCB and/or UCT may become contaminated or may be damaged, lost or destroyed during the process of collection, temporary storage, transportation, processing, cryogenic freezing or final storage
2.9.6 CryoSave cannot be held liable for any such event.
2.9.7 I consent to: Storage of additional reference samples from the UCB and/or UCT of the Child for future testing including cell count and viability, sterility, quality assurance and processing.
3.1 I understand that:
3.1.1 Should any maternal blood test result or baby’s cord blood test result be abnormal, my attending Healthcare Practitioner (or baby’s paediatrician, if applicable), will be informed of the result in a confidential manner.
3.1.2 All information will be processed confidentially according to applicable legislation.
3.2 I hereby authorise CryoSave:
3.2.1 To process my health records in a manner that assures discretion and confidentiality.
3.2.2 To disclose this information to other relevant healthcare professionals when this is essential for medical purposes only.
3.3 To request additional information when this is essential for medical purposes only.
4. Maternal blood tests
4.1 I, the birth Mother, understand that certain maternal blood tests are required from me to evaluate the suitability of the stem cells for transplantation and in accordance with international accreditation requirements, should a transplant be considered.
4.2 Tests include, but may not be limited to, Hepatitis B, Hepatitis C, HIV, CMV and STDs. Please discuss these tests with your Health Care Professional before you have the tests done.
4.3 Pre– and post-test information and counselling is available through your Healthcare Practitioner and/or the Laboratory Medical Director upon request.
4.4 I consent to the above testing.
5. Please notify us if this pregnancy was assisted by
Surrogate Mother (additional form required), Donor Egg or Sperm, IVF Assisted, Other
6. Approved use of the collected stem cells
6.1 The Client declares that he/she/they understand that:
6.1.1. Stem cells are for family use in most instances, thus stem cells are for use by the Child and/or his/her family for FDA approved diseases.
6.1.2. In the case of the stem cells not being viable, or no longer required, or on termination of the agreement, the material may be destroyed/ used for testing/ donated (with informed consent of the client).
6.1.3. Hence the material may thereafter no longer be available to the Child or the Child’s family.
7.1 I authorise the disposal of my stem cells, with my consent and with the approval of the Laboratory Director, under the following conditions:
7.1.1. An insufficient volume of cord blood collected for processing
7.1.2. An insufficient number of stem cells in the collection
7.1.3. A collection contaminated with a micro-organism
7.1.4. A low percentage of viable stem cells
7.1.5. The stem cells are no longer required
7.1.6. Termination of the Agreement
7.2. I understand that:
7.2.1. The stem cells will be discarded according to the Waste Disposal Policy that meets applicable laws and regulations for disposal of biohazardous materials and/or medical waste in South Africa.
7.2.2. Documented evidence of the disposal of the stem cells and associated tissue will be recorded. A copy will be made available to me on request.
7.2.3. Blood and tissue stem cells will thereafter no longer be available to the Child or the Child’s family.
8. Data and Quality control
8.1 CryoSave, from time to time evaluates the medical information, cord blood collection and processing results (the laboratory data) obtained from the UCB and/or UCT collections in its Quality Assurance Program.
8.2 CryoSave may from time to time present this information at medical or scientific meetings and may publish the laboratory data, for education purposes, in a medical or scientific journal.
8.3 Medical information and laboratory data are always presented in an anonymous and unassociated manner. This means that any personal information that could identify you or your baby is removed from the data. Please indicate your preference below. Whatever your choice, this will not influence the processing or storage of your baby’s stem cells in any way.
8.4 I agree that the data can be used for educational purposes in a way that will not identify me or my baby.
9. Client responsibility
9.1. The Client assumes the responsibility for ensuring that CryoSave is notified of the birth of the Child no later than one hour after the birth and that the maternal blood tests are collected soon after the birth. A delay in the above-mentioned process may affect the viability of the UCB and/ or UCT and CryoSave cannot be held responsible for such delay or its consequences.
10.1 I have been informed of the reasons for stem cell collection, the collection procedure itself and the purpose of further processing and storage by CryoSave.
10.2 I have been informed of the possible risks, benefits and costs to me/us and/or the Child, including medical and ethical concerns, have been explained.
10.3 I/we declare that: I/we agree to provide information related to my/our medical and genetic history.
10.4 I/we declare that: I/we understand that the stem cells will not be available for public use, unless specifically authorised by me/us.
10.5 I/we declare that: I/we understand that any abnormal results found during analysis will be communicated to me/us and/or to the health care practitioner, by the Laboratory Director/Medical Director.
10.6 I/we further confirm that I/we have been properly informed and that I/we received and clearly understood the information given, and further declare that
10.7 I/we declare that: I/we are satisfied with all the information given. In addition, I/we have had sufficient time to consider the information and have had the opportunity to ask questions, to which I/we received satisfactory answers from my/our Healthcare Practitioner or authorised representative.
10.8 I/we declare that: The Client herewith gives her/his/their consent for the collection, processing, testing and storage of the umbilical cord blood (UCB) and/or umbilical cord tissue