Fertility service for preservation and use of reproductive tissue for service users who cannot store mature eggs/sperm who are at high/very high risk of infertility - Competitive Process

Description

NHS Arden and Greater East Midlands Commissioning Support Unit (AGCSU), on behalf of NHS England (referred to as the Authority), is inviting suitably qualified and experienced providers to respond to this Competitive Process for the provision of a Fertility service for preservation and use of reproductive tissue for service users who cannot store mature eggs/sperm who are at high/very high risk of infertility.<br/><br/>* Lot 1 - Hub - (2 providers - 1 provider to cover North East, North West, Yorkshire & Humber and Midlands NHS Regions and 1 provider to cover East of England, London, South East and South West NHS Regions) <br/><br/>* Lot 2 - Tissue Establishment - (2 providers - 1 provider to cover North East, North West, Yorkshire & Humber and Midlands NHS Regions and 1 provider to cover East of England, London, South East and South West NHS Regions) <br/><br/>* Lot 3 - Fertility & Endocrine Restoration Services (2 providers - 1 provider to cover North East, North West, Yorkshire & Humber and Midlands NHS Regions and 1 provider to cover East of England, London, South East and South West NHS Regions) <br/><br/>The service is due to commence on 1st April 2026 or sooner if possible.<br/><br/>The contract period is 5 years with Commissioners having the option to extend for up to a further 58 months.<br/><br/>Please note that the contract values included in this notice are the estimated maximum available over the whole potential contract period (5 years + 58 months) and are inclusive of VAT. <br/><br/>To express interest and participate in the Competitive Process, please register and access documentation via the Atamis (Health Family) portal: https://atamis-1928.my.site.com/s/Welcome Should providers have any queries, or have problems using the portal, they should contact Helpdesk at: Phone: 0800 9956035 E-mail: support-health@atamis.co.uk<br/><br/>A provider event via Microsoft Teams is planned for Tuesday 12th August 2025 at 3pm. If you would like to attend, please email anna.salt@nhs.net to register by 5pm on Monday 11th August 2025. All slides, questions<br/>and responses will be made available to all providers following this event via Atamis.<br/><br/>The response deadline is 12pm, noon, on Friday 26th September 2025 and the project reference in Atamis is C371608. Lot 1: Lot 1 - Hub NHS England has published three service specifications that describe an integrated single fertility preservation and restoration programme led by and co-ordinated through a Hub model arrangement. The Hub is a hospital based clinical service and will provide a fertility preservation programme, coordination of service provision across services, leadership and advice. <br/><br/>The requirements of this service are described in the specifications: <br/>https://www.england.nhs.uk/publication/service-specifications-fertility-preservation-and-restoration/ <br/><br/>The Hub also participates in and receives expert clinical and technical advice from a National Expert Group. <br/><br/>This model has been designed to centralises the specialist fertility expertise in the Hub whilst enabling ovarian and testicular tissue collection surgery to take place in the service user’s local surgical treatment centre (Spoke). The tissue is then processed, cryopreserved, and stored at an appointed Tissue Establishment licenced by the Human Tissue Authority. <br/><br/>The programme also covers the provision of fertility and endocrine restoration for service users who have cryopreserved ovarian tissue. The programme does not currently include the restoration of testicular tissue as unlike ovarian tissue restoration, it is not currently clinically available for males. However, if this does become available over the life of the contract, it may be included by means of a contract modification. <br/><br/>The scope of the service is to commission an integrated, expert led fertility preservation and restoration programme for service users who cannot store mature eggs/sperm who are at high/very high risk of infertility. The population covered by the service specifications include people who meet the eligibility criteria, supported by evidence. Whilst the evidence is predominantly linked to children’s cancer and leukaemia onco fertility guidelines for patients receiving chemotherapy and radiotherapy, the Hub will be informed by similar guidelines for other service users and will receive diagnostic expert advice on these areas from the National Expert Group. Given the specialised nature of this service, referrals from the devolved nations and further afield may also be received and accepted subject to appropriate commissioning arrangements and approvals. <br/><br/>This Competitive Process will compliment and be integrated with other fertility preservation programmes funded by NHS England. <br/><br/>The Hub will provide the overall leadership to the integrated fertility programme. The service model centralises the specialist fertility expertise in the Hub whilst enabling ovarian and testicular tissue collection via surgery to take place in the service user’s local surgical treatment centre, the spoke site. The Hub will work with the auto-transplantation sites to ensure referral pathways for use of ovarian tissue to restore fertility and endocrine function. <br/><br/>The Hub and associated Spokes will work with a designated Tissue Establishment (TE) that holds a Human Tissue Authority (HTA) Human Application Sector Licence for reproductive tissue procurement, processing, testing, storage, distribution and disposal of tissue, to manage fertility preservation treatment by storage of reproductive tissue.<br/><br/>The Spoke sites will be located in hospital-based services which are Children and Young Adult Cancer Principal Treatment Centres / Bone Marrow Treatment (BMT) centres. The Hub and Spoke services will need to work with the designated TE to ensure the collection of the surgically removed tissue and transfer of the tissue to TE via a courier transport service is in accordance with the HTA licence requirements. <br/><br/>The Tissue Establishment(s) must operate in compliance with the Human Tissue Authority Quality and Safety Standards and hold a Human Tissue Authority Human Application Sector Licence for reproductive tissue procurement, processing, testing, storage, distribution and disposal of tissue. <br/><br/>The Tissue Establishment will need to establish third party /Service Level Agreement (SLA) with the Hub, Spokes and Fertility Restoration Services. <br/><br/>Fertility and endocrine restoration using cryopreserved ovarian tissue will need to be provided via ovarian tissue auto-transplantation surgery and will be undertaken in centres capable of the management and oversight of the auto-transplantation service. <br/><br/>Once the service is in place, compliance with the service specifications will be assessed via the quality surveillance assurance process as part of the Specialised Commissioning Quality Assurance & Improvement Framework. Standard formal reporting processes will commence from the agreed go live date and include quarterly submission of SSQD data.<br/><br/>The Hub and spoke elements of the fertility service will need to work with the Tissue Establishment to ensure that the fertility preservation treatment by cryopreservation of tissue is undertaken in compliance with HTA licence requirements. The Tissue Establishment will be subject to regular inspection by the HTA to ensure compliance of their work with HTA licence regulations.<br/><br/>Commissioned Providers must be able to demonstrate that they meet all aspects of the service specification for the Lots that they are intending to provide. <br/><br/>Commissioned Providers must be able to demonstrate that they can meet the demand for services in line with the service demand assumptions agreed with commissioners and that their capacity plan has sufficient flexibility to ensure patients primary treatment will not be delayed.<br/><br/>Interested parties may respond to this ITT in partnership with other organisations as part of a consortium, subject to them appointing a consortium lead to act on their behalf as the lead contracting party. The lead contracting party would take overall responsibility for delivery of the service(s) in accordance with the requirements of any future contract(s) if successful.<br/><br/>Please note that the contract values included in this notice are the estimated maximum available over the whole potential contract period (5 years + 58 months) and are inclusive of VAT.<br/><br/>To express interest and participate in the Competitive Process, please register and access documentation via the Atamis (Health Family) portal: https://atamis-1928.my.site.com/s/Welcome Should providers have any queries, or have problems using the portal, they should contact Helpdesk at: Phone: 0800 9956035 E-mail: support-health@atamis.co.uk<br/><br/>A provider event via Microsoft Teams is planned for Tuesday 12th August 2025 at 3pm. If you would like to attend, please email anna.salt@nhs.net to register by 5pm on Monday 11th August 2025. All slides, questions<br/>and responses will be made available to all providers following this event via Atamis.<br/><br/>The response deadline is 12pm, noon, on Friday 26th September 2025 and the project reference in Atamis is C371608.<br/><br/>This is a Provider Selection Regime (PSR) Contract Notice. The awarding of this contract is subject to the Health Care Services (Provider Selection Regime) Regulations 2023. For the avoidance of doubt, the provisions of the Public Contracts Regulations 2015 do not apply to this award.<br/><br/>The decision maker of the award will be: NHS England - National Commissioning Group.<br/><br/>The intention is to award a contracts using the Competitive Process.<br/><br/>The announcement by Government, on 13th March 2025, will not disrupt commissioning and contracting of this service. NHS England continues to exist as a statutory body for now. The dissolution of NHS England during the term of the contract will be subject to an act of Parliament and its undertakings will be transferred as appropriate. As and when NHS England is dissolved, commissioning responsibilities will be transferred to an alternative commissioning authority. At this time, the General Condition 12 ‘Assignment and Sub-Contracting’ of the NHS Standard Contract, as per the obligations of the commissioner, will set out the terms and conditions under which the contract will be transferred or assigned to the relevant commissioning authority. Lot 2: Lot 2 - Tissue Establishment NHS England has published three service specifications that describe an integrated single fertility preservation and restoration programme led by and co-ordinated through a Hub model arrangement. The Hub is a hospital based clinical service and will provide a fertility preservation programme, coordination of service provision across services, leadership and advice. <br/><br/>The requirements of this service are described in the specifications: <br/>https://www.england.nhs.uk/publication/service-specifications-fertility-preservation-and-restoration/ <br/><br/>The Hub also participates in and receives expert clinical and technical advice from a National Expert Group. <br/><br/>This model has been designed to centralises the specialist fertility expertise in the Hub whilst enabling ovarian and testicular tissue collection surgery to take place in the service user’s local surgical treatment centre (Spoke). The tissue is then processed, cryopreserved, and stored at an appointed Tissue Establishment licenced by the Human Tissue Authority. <br/><br/>The programme also covers the provision of fertility and endocrine restoration for service users who have cryopreserved ovarian tissue. The programme does not currently include the restoration of testicular tissue as unlike ovarian tissue restoration, it is not currently clinically available for males. However, if this does become available over the life of the contract, it may be included by means of a contract modification. <br/><br/>The scope of the service is to commission an integrated, expert led fertility preservation and restoration programme for service users who cannot store mature eggs/sperm who are at high/very high risk of infertility. The population covered by the service specifications include people who meet the eligibility criteria, supported by evidence. Whilst the evidence is predominantly linked to children’s cancer and leukaemia onco fertility guidelines for patients receiving chemotherapy and radiotherapy, the Hub will be informed by similar guidelines for other service users and will receive diagnostic expert advice on these areas from the National Expert Group. Given the specialised nature of this service, referrals from the devolved nations and further afield may also be received and accepted subject to appropriate commissioning arrangements and approvals. <br/><br/>This Competitive Process will compliment and be integrated with other fertility preservation programmes funded by NHS England. <br/><br/>The Hub will provide the overall leadership to the integrated fertility programme. The service model centralises the specialist fertility expertise in the Hub whilst enabling ovarian and testicular tissue collection via surgery to take place in the service user’s local surgical treatment centre, the spoke site. The Hub will work with the auto-transplantation sites to ensure referral pathways for use of ovarian tissue to restore fertility and endocrine function. <br/><br/>The Hub and associated Spokes will work with a designated Tissue Establishment (TE) that holds a Human Tissue Authority (HTA) Human Application Sector Licence for reproductive tissue procurement, processing, testing, storage, distribution and disposal of tissue, to manage fertility preservation treatment by storage of reproductive tissue.<br/><br/>The Spoke sites will be located in hospital-based services which are Children and Young Adult Cancer Principal Treatment Centres / Bone Marrow Treatment (BMT) centres. The Hub and Spoke services will need to work with the designated TE to ensure the collection of the surgically removed tissue and transfer of the tissue to TE via a courier transport service is in accordance with the HTA licence requirements. <br/><br/>The Tissue Establishment(s) must operate in compliance with the Human Tissue Authority Quality and Safety Standards and hold a Human Tissue Authority Human Application Sector Licence for reproductive tissue procurement, processing, testing, storage, distribution and disposal of tissue. <br/><br/>The Tissue Establishment will need to establish third party /Service Level Agreement (SLA) with the Hub, Spokes and Fertility Restoration Services. <br/><br/>Fertility and endocrine restoration using cryopreserved ovarian tissue will need to be provided via ovarian tissue auto-transplantation surgery and will be undertaken in centres capable of the management and oversight of the auto-transplantation service. <br/><br/>Once the service is in place, compliance with the service specifications will be assessed via the quality surveillance assurance process as part of the Specialised Commissioning Quality Assurance & Improvement Framework. Standard formal reporting processes will commence from the agreed go live date and include quarterly submission of SSQD data.<br/><br/>The Hub and spoke elements of the fertility service will need to work with the Tissue Establishment to ensure that the fertility preservation treatment by cryopreservation of tissue is undertaken in compliance with HTA licence requirements. The Tissue Establishment will be subject to regular inspection by the HTA to ensure compliance of their work with HTA licence regulations.<br/><br/>Commissioned Providers must be able to demonstrate that they meet all aspects of the service specification for the Lots that they are intending to provide. <br/><br/>Commissioned Providers must be able to demonstrate that they can meet the demand for services in line with the service demand assumptions agreed with commissioners and that their capacity plan has sufficient flexibility to ensure patients primary treatment will not be delayed.<br/><br/>Interested parties may respond to this ITT in partnership with other organisations as part of a consortium, subject to them appointing a consortium lead to act on their behalf as the lead contracting party. The lead contracting party would take overall responsibility for delivery of the service(s) in accordance with the requirements of any future contract(s) if successful.<br/><br/>Please note that the contract values included in this notice are the estimated maximum available over the whole potential contract period (5 years + 58 months) and are inclusive of VAT.<br/><br/>To express interest and participate in the Competitive Process, please register and access documentation via the Atamis (Health Family) portal: https://atamis-1928.my.site.com/s/Welcome Should providers have any queries, or have problems using the portal, they should contact Helpdesk at: Phone: 0800 9956035 E-mail: support-health@atamis.co.uk<br/><br/>A provider event via Microsoft Teams is planned for Tuesday 12th August 2025 at 3pm. If you would like to attend, please email anna.salt@nhs.net to register by 5pm on Monday 11th August 2025. All slides, questions<br/>and responses will be made available to all providers following this event via Atamis.<br/><br/>The response deadline is 12pm, noon, on Friday 26th September 2025 and the project reference in Atamis is C371608.<br/><br/>This is a Provider Selection Regime (PSR) Contract Notice. The awarding of this contract is subject to the Health Care Services (Provider Selection Regime) Regulations 2023. For the avoidance of doubt, the provisions of the Public Contracts Regulations 2015 do not apply to this award.<br/><br/>The decision maker of the award will be: NHS England - National Commissioning Group.<br/><br/>The intention is to award a contracts using the Competitive Process.<br/><br/>The announcement by Government, on 13th March 2025, will not disrupt commissioning and contracting of this service. NHS England continues to exist as a statutory body for now. The dissolution of NHS England during the term of the contract will be subject to an act of Parliament and its undertakings will be transferred as appropriate. As and when NHS England is dissolved, commissioning responsibilities will be transferred to an alternative commissioning authority. At this time, the General Condition 12 ‘Assignment and Sub-Contracting’ of the NHS Standard Contract, as per the obligations of the commissioner, will set out the terms and conditions under which the contract will be transferred or assigned to the relevant commissioning authority. Lot 3: Lot 3 - Fertility & Endocrine Restoration Service NHS England has published three service specifications that describe an integrated single fertility preservation and restoration programme led by and co-ordinated through a Hub model arrangement. The Hub is a hospital based clinical service and will provide a fertility preservation programme, coordination of service provision across services, leadership and advice. <br/><br/>The requirements of this service are described in the specifications: <br/>https://www.england.nhs.uk/publication/service-specifications-fertility-preservation-and-restoration/ <br/><br/>The Hub also participates in and receives expert clinical and technical advice from a National Expert Group. <br/><br/>This model has been designed to centralises the specialist fertility expertise in the Hub whilst enabling ovarian and testicular tissue collection surgery to take place in the service user’s local surgical treatment centre (Spoke). The tissue is then processed, cryopreserved, and stored at an appointed Tissue Establishment licenced by the Human Tissue Authority. <br/><br/>The programme also covers the provision of fertility and endocrine restoration for service users who have cryopreserved ovarian tissue. The programme does not currently include the restoration of testicular tissue as unlike ovarian tissue restoration, it is not currently clinically available for males. However, if this does become available over the life of the contract, it may be included by means of a contract modification. <br/><br/>The scope of the service is to commission an integrated, expert led fertility preservation and restoration programme for service users who cannot store mature eggs/sperm who are at high/very high risk of infertility. The population covered by the service specifications include people who meet the eligibility criteria, supported by evidence. Whilst the evidence is predominantly linked to children’s cancer and leukaemia onco fertility guidelines for patients receiving chemotherapy and radiotherapy, the Hub will be informed by similar guidelines for other service users and will receive diagnostic expert advice on these areas from the National Expert Group. Given the specialised nature of this service, referrals from the devolved nations and further afield may also be received and accepted subject to appropriate commissioning arrangements and approvals. <br/><br/>This Competitive Process will compliment and be integrated with other fertility preservation programmes funded by NHS England. <br/><br/>The Hub will provide the overall leadership to the integrated fertility programme. The service model centralises the specialist fertility expertise in the Hub whilst enabling ovarian and testicular tissue collection via surgery to take place in the service user’s local surgical treatment centre, the spoke site. The Hub will work with the auto-transplantation sites to ensure referral pathways for use of ovarian tissue to restore fertility and endocrine function. <br/><br/>The Hub and associated Spokes will work with a designated Tissue Establishment (TE) that holds a Human Tissue Authority (HTA) Human Application Sector Licence for reproductive tissue procurement, processing, testing, storage, distribution and disposal of tissue, to manage fertility preservation treatment by storage of reproductive tissue.<br/><br/>The Spoke sites will be located in hospital-based services which are Children and Young Adult Cancer Principal Treatment Centres / Bone Marrow Treatment (BMT) centres. The Hub and Spoke services will need to work with the designated TE to ensure the collection of the surgically removed tissue and transfer of the tissue to TE via a courier transport service is in accordance with the HTA licence requirements. <br/><br/>The Tissue Establishment(s) must operate in compliance with the Human Tissue Authority Quality and Safety Standards and hold a Human Tissue Authority Human Application Sector Licence for reproductive tissue procurement, processing, testing, storage, distribution and disposal of tissue. <br/><br/>The Tissue Establishment will need to establish third party /Service Level Agreement (SLA) with the Hub, Spokes and Fertility Restoration Services. <br/><br/>Fertility and endocrine restoration using cryopreserved ovarian tissue will need to be provided via ovarian tissue auto-transplantation surgery and will be undertaken in centres capable of the management and oversight of the auto-transplantation service. <br/><br/>Once the service is in place, compliance with the service specifications will be assessed via the quality surveillance assurance process as part of the Specialised Commissioning Quality Assurance & Improvement Framework. Standard formal reporting processes will commence from the agreed go live date and include quarterly submission of SSQD data.<br/><br/>The Hub and spoke elements of the fertility service will need to work with the Tissue Establishment to ensure that the fertility preservation treatment by cryopreservation of tissue is undertaken in compliance with HTA licence requirements. The Tissue Establishment will be subject to regular inspection by the HTA to ensure compliance of their work with HTA licence regulations.<br/><br/>Commissioned Providers must be able to demonstrate that they meet all aspects of the service specification for the Lots that they are intending to provide. <br/><br/>Commissioned Providers must be able to demonstrate that they can meet the demand for services in line with the service demand assumptions agreed with commissioners and that their capacity plan has sufficient flexibility to ensure patients primary treatment will not be delayed.<br/><br/>Interested parties may respond to this ITT in partnership with other organisations as part of a consortium, subject to them appointing a consortium lead to act on their behalf as the lead contracting party. The lead contracting party would take overall responsibility for delivery of the service(s) in accordance with the requirements of any future contract(s) if successful.<br/><br/>Please note that the contract values included in this notice are the estimated maximum available over the whole potential contract period (5 years + 58 months) and are inclusive of VAT.<br/><br/>To express interest and participate in the Competitive Process, please register and access documentation via the Atamis (Health Family) portal: https://atamis-1928.my.site.com/s/Welcome Should providers have any queries, or have problems using the portal, they should contact Helpdesk at: Phone: 0800 9956035 E-mail: support-health@atamis.co.uk<br/><br/>A provider event via Microsoft Teams is planned for Tuesday 12th August 2025 at 3pm. If you would like to attend, please email anna.salt@nhs.net to register by 5pm on Monday 11th August 2025. All slides, questions<br/>and responses will be made available to all providers following this event via Atamis.<br/><br/>The response deadline is 12pm, noon, on Friday 26th September 2025 and the project reference in Atamis is C371608.<br/><br/>This is a Provider Selection Regime (PSR) Contract Notice. The awarding of this contract is subject to the Health Care Services (Provider Selection Regime) Regulations 2023. For the avoidance of doubt, the provisions of the Public Contracts Regulations 2015 do not apply to this award.<br/><br/>The decision maker of the award will be: NHS England - National Commissioning Group.<br/><br/>The intention is to award a contracts using the Competitive Process.<br/><br/>The announcement by Government, on 13th March 2025, will not disrupt commissioning and contracting of this service. NHS England continues to exist as a statutory body for now. The dissolution of NHS England during the term of the contract will be subject to an act of Parliament and its undertakings will be transferred as appropriate. As and when NHS England is dissolved, commissioning responsibilities will be transferred to an alternative commissioning authority. At this time, the General Condition 12 ‘Assignment and Sub-Contracting’ of the NHS Standard Contract, as per the obligations of the commissioner, will set out the terms and conditions under which the contract will be transferred or assigned to the relevant commissioning authority.