Usługi zarządzane w zakresie radiofarmacji

Guy's and St Thoma's NHS Foundation Trust (Contracting Authority) is undertaking this procurement to appoint a Service Provider to enter into an MSA for the provision of Radiopharmacy manufacturing services, delivered through a Hub and Spoke operating model. The Trust’s existing Radiopharmacy Unit, located at Guy’s Hospital (the “Spoke”), provides highly specialised diagnostic, therapeutic and research support to Nuclear Medicine and other clinical services within the GSTT, Royal Brompton and Harefield Hospitals. Radiopharmacy services are integral to a wide range of patient pathways, including diagnostic imaging, cancer diagnosis and treatment, clinical trials and research activity. Demand for radiopharmaceuticals is expected to continue to increase in line with advances in imaging, personalised medicine and oncology pathways. The Contracting Authority’s existing facilities are constrained by physical space, ageing infrastructure and regulatory limitations, which restrict capacity and prevent expansion. The Contracting Authority has therefore determined that an MSA represents the most appropriate mechanism to deliver a new, off site, GMP compliant Radiopharmacy Hub, while retaining a reduced on site Spoke function during the initial phase of service delivery. This approach will enable increased production capacity, improved resilience of supply, enhanced regulatory compliance and long-term sustainability. The Trust intends to implement the Hub and Spoke model through a phased delivery approach. Upon contract award the appointed Service Provider will be responsible for the design and fit-out of the Hub during the first year of the MSA/Contract. During the second year, the Service Provider shall obtain all relevant regulatory licenses with the commencement of services initiating Phase 1 of the Hub starting in the third year. During this phase, the existing Spoke at Guy’s Hospital will continue to provide defined on site radiopharmacy functions to support clinical continuity, resilience and safe transition to the new operating model. These timings are estimates and Tenderers are required to provide a detailed mobilisation as part of their response to Questionnaire 3: Technical and Social Value Questionnaire). At the sole discretion of the Contracting Authority, Phase 2 may be initiated, to transfer additional manufacturing activities from the Spoke to the Hub once the Hub is fully operational, stable and licensed. Phase 2 is not guaranteed and will only be implemented following an initial period from service commencement. Any decision to proceed with Phase 2 will be subject to performance, regulatory and operational readiness criteria as set out in Document 2: Managed Service Agreement). Further detail on the phasing of Services and associated TUPE arrangements is provided in Section 6.6 and the Document 2: Managed Service Agreement). The MSA and procurement documentation have been structured to accommodate this potential future phase in a transparent and compliant manner. This ITT therefore seeks Tenders from suitably qualified and experienced organisations capable of designing, establishing, licensing and operating the Radiopharmacy Hub and working in partnership with the Contracting Authority over the life of the Contract. The scope of Services, phased delivery arrangements and contractual requirements are set out within the ITT Pack, including Document 2: Managed Service Agreement (MSA).