The third party agreement (“Agreement”) has been entered into between Sussex Sperm Bank (“SXSB”) and the third party whose details are listed in clause 2 below (“Third Party”), together known as the (“Parties”) and individually as a (“Party”).
APPENDIX 1- SERVICE LEVELS
1. Standard Responsibilities of the Supplier (SXSB), we can confirm that:
a) SXSB is appropriately licensed by the HFEA
b) SXSB shall reasonably endeavour to supply ordered product(s) state within 14 working days of fertility centre acceptance, if possible. In the event that the product is currently unavailable immediately (for example: awaiting clearance screening) then the supplier will supply it as soon as possible in line with regulation
c) SXSB shall ensure the products supplied are fit for the purpose intended
d) Should a delivery contain any damaged items upon delivery then the Fertility Centre shall immediately notify the supplier and arrange for the return of such items as required; SXSB shall deliver and replace damaged items free of charge unless damage is caused by the Fertility Centre;
e) If the quantity of the goods delivered is less than the contracted quantity then the SXSB shall either expedite a further delivery to make up the deficiency or reduce the price of the goods, at The Fertility Centre’s decision, and
f) In the event of non-delivery, The Fertility Centre will notify the supplier immediately whereupon the supplier shall arrange for a further delivery immediately.
g) Delivery of sperm will only be made after full payment by the patient(s)
h) SXSB confirms we comply with all UK donor legislation including but not limited to the Human Fertilisation and Embryology Act as amended (2008), storage regulations and relevant professional guidance
i) All donors have consented to the use of their sperm for donation in the UK
j) All donors have consented to 10 families unless stated otherwise. SXSB will ensure that only 10 family slots are allocated to one donor at one time. Negative treatment results are confirmed with the treating centre and SXSB will only release slots once negative results are confirmed in writing
k) All patient information used for the sample release process is held securely at the SXSB site and is confidential according to the terms of the HFEA and Data Security Protocols. No personal data is transferred to other parties without specific permission and follows the new GDPR regulation and Data Protection Act 2018
l) All SXSB donors are given compensation compliant with HFEA regulation only (£35 per donation) [HFEA SLC T69 and General Direction 0001]
2. Notification of Product Variation by SXSB
a) SXSB shall notify The Fertility Centre of any changes, including specification change
b) SXSB shall notify The Fertility Centre of any product recall or product defects of which the supplier becomes aware as soon as possible
c) SXSB shall notify The Fertility Centre of any new information regarding the donors’ medical status which may come to light after donation, as soon as reasonably possible, for example: new genetic conditions which were previously not known or tested for
d) SXSB shall notify The Fertility Centre of any changes in donor consent as soon as possible, including withdrawn consent
e) SXSB shall notify The Fertility Centre of any serious adverse events or reactions that may be applicable to the samples and/or donor as soon as possible
3. Safety and Quality
SXSB agreed to take full responsibility to ensure that they fully meet the requirements of all relevant license conditions and guidance set out in the Human Fertilisation and Embryology Authority (HFEA) Code of Practise 9th Edition. SXSB shall
a) Ensure the temperature of the donor sperm supplied is maintained below critical biological temperature during transport and the shippers used are validated, fit for purpose and used for fully screened samples only
b) The shipper is tamper proof, samples are not left unattended during transit and the courier provides a full chain of custody direct from SXSB to The Fertility Centre
c) Provide evidence of screening tests and negative results, HFEA MD consent form, HFEA Donor Information form, HFEA CD form, sample information, preparation instructions, SEC coding and any other relevant forms pertaining to the donated gametes
d) All paperwork will be kept secure and confidential during transit and electronically prior to the transfer
e) All shipments are fully labelled to the HFEA specifications
f) All certification and documentation regarding the donor or freezing media is available upon request for traceability purposes.
g) All samples will have relevant SEC coding in line with HFEA regulation. SEC coding is on all samples procured after 16.04.18. Samples procured before 16.04.18 will not be labelled with the SEC code, however the SEC code will be generated and hand written on the goblet holding the straw(s) where possible and on all clinic letters.
- i. All blood and urine screening is performed at an accredited laboratory.
- ii. All screening has been performed in line with relevant professional guidelines and HFEA regulation, however where donors have completed their donation cycle prior to guideline changes, retrospective testing is not always possible nor necessary as per HFEA guidance.
4. Specific reciprocal requirements for the receiving Fertility Centre
The receiving Fertility Centre will agree to the following conditions for use of the donor sperm:
a) The Centre must inform SXSB of any issues which may affect quality or safety during transit as soon as reasonably possible
b) All donor information is kept strictly confidential as identity release is only available for the donor conceived child. The Fertility Centre has access to privileged donor information and has a responsibility to maintain confidentiality at all times. This may involve The Fertility Centre maintaining specific SOP for photocopying clients notes / email communications which may contain identifiable donor information and anonymising documents where appropriate
c) Any breach in confidentiality of donors should be reported to SXSB as soon as possible as well as to the relevant bodies
d) The Fertility Centre should adhere to all suggested thawing protocols which will be supplied on clinic letters accompanying samples upon delivery and also best practice as defined by the ARCS
e) The Fertility Centre will be responsible for all health and safety of any samples once in their storage. This includes wearing of suitable PPE including eye protection, during sample transfer between shipper and storage tanks
f) If ampoules are transferred then additional safety protocols should be applied including eye protection and PPE, minimal exposure to warming and rapid witnessing checks
g) As users of SXSB donor samples, The Centre MUST inform SXSB of any use, any result (including embryos created and stored) or any pregnancy after using the donor sperm so SXSB can effectively manage its requirements for the 10 family rule
h) The Fertility Centre MUST inform SXSB of any treatment outcomes as soon as reasonably possible. This must be within a month of the initial treatment date in written form either via email or SXSB treatment outcome form supplied with shipment. Failure to report correct outcomes to SXSB puts the donor 10 family record at risk of breach. Therefore, if the fertility centre reports something incorrectly, they will ultimately be held responsible
i) Management of donor sample expiry dates (especially for sibling stock) must be managed by the receiving Fertility Centre’s own storage SOP. All donor consent for 55 years for frozen embryos to allow for any medical storage issues
j) The Fertility Centre ensures that the recipients of the donor sperm have had appropriate implications counselling, including risks of using donor sperm and parental responsibility issues
k) In the event of a poor thaw, the Fertility Centre should report to SXSB immediately by returning the feedback form provided with the sample shipment OR by contacting SXSB by phone/email. This should be reported prior to speaking to the patient as far as possible for the Fertility Centre. SXSB cannot be responsible for sperm post preparation issues
l) The Fertility Centre should ensure that all their suppliers and service providers for equipment and consumables are accredited and regulated in line with HFEA requirements. The Fertility Centre should have relevant Third Party Agreements with all suppliers and service providers that could be produced to SXSB if requested
APPENDIX 2 – DATA SHARING
1. Definitions
1.1 The following definitions shall apply to this Appendix 2:
- “Controller” shall have the meaning set out in the Data protection Legislation;
- “Data Protection Legislation” means all applicable and data protection and privacy legislation, regulations and guidance including but not limited to the Data Protection Act 2018, the Privacy and Electronic Communications (EC Directive) Regulations and any guidance or codes of practise (all as amended, updated and re-enacted from time to time).
- “Data Subject” shall have the meaning set out in the Data Protection Legislation;
- “Personal Data” shall have the meaning set out in the Data Protection Legislation;
- “Processing” shall have the meaning set out in the Data Protection Legislation; (and “Process” and “Processed” shall be construed accordingly); and
- “Regulators” means the Information Commissioner’s Office or any successor body to any regulator from time to time and any other supervisory authority with jurisdiction over either Party.
2. Data Sharing
2.1 Client’s notes request – Please note that if copies are printed for a patient notes request – your protocols MUST ensure that all donors reports are anonymised to protect donor identity before forwarding to a patient or another clinic.
2.2 The Parties agree that each shall be a Controller in relation to any Personal Data Exchange under the Agreement. Each Party shall comply with its obligations as a Controller under the Data Protection Legislation.
2.3 Personal Data to be shared under this Agreement according to HFEA Code of Practice.
2.4 When one Party is transferring Personal Data ( the “Disclosing Party”) to the other Party (the “Receiving Party”), the Disclosing Party shall ensure that any Personal Data that is transferred:
2.4.1 has been collected in accordance with the Data Protection Legislation; and
2.4.2 the fair processing notice given to the relevant Data Subject entitles the Receiving Party Process such Personal Data for the purposes set out in this Agreement.
2.5 In the event that the Receiving Party determines that it is required to provide its own fair processing notice to Data Subjects, the Disclosing Party will provide accurate and up to date contact details for the Data Subjects whose Personal Data has been transferred under this Agreement.
2.6 Where the Disclosing Party relies on the consent of the Data Subject to meet its obligations under clause 2.3, the Disclosing Party warrants that:
2.6.1 the consent entitles the Receiving Party to Process the Personal Data for the purposes set out in this Agreement;
2.6.2 it will promptly notify the Receiving Party in the event that the relevant Data Subject withdraws his or her consent.
2.7 Neither Party shall Process Personal Data transferred under his Agreement for any purposes other than those set out in this Agreement.
2.8 No assurance is given by either Party regarding the lawfulness of the Processing of any data obtained pursuant to this Agreement by the other Party.
2.9 Without limitation to clause 2.1, each Party shall:
2.9.1 implement and maintain appropriate technical and organisational measures to protect such Personal Data against unauthorised or unlawful Processing and against accidental loss or destruction of, or damage;
2.9.2 ensure that employees who have access to Personal Data have undergone training in the Data Protection Legislation and in the care and handling of Personal Data;
2.9.3 not disclose Personal Data to any third party in any circumstances except as required or permitted by this Agreement; and
2.9.4 notify the other Party promptly of any known breach of technical and organisational security measures where the breach has affected or could have affected Personal Data transferred under this Agreement.
2.10 In the event of a request relating to Personal Data transferred under this Agreement from a Data Subject for the rectification or erasure of Personal Data or restriction of Processing, the Party who has received the request shall determine whether such request is valid under the Data Protection Legislation. In the event that the Party which has received the request determines that the relevant Personal Data should be rectified or erased or that any Processing shall be restricted, it shall notify the other Party Promptly. The Party receiving the notification shall rectify or erase the Personal Data or restrict Processing (as applicable) promptly.
2.11 On receipt of any request or enquiry from the Regulator that relates to Personal Data transferred under this Agreement, each Party shall provide the other with all reasonable assistance to allow the Party in receipt of the request to respond.
2.12 Each Party shall bear its own costs incurred in providing the assistance set out in clauses 2.10 and 2.11.