Children’s Health Ireland (CHI) is investing in new services and consolidating paediatric services from its existing acute sites in Dublin (Crumlin, Temple Street, and paediatric services at Tallaght) into the new purpose‑built Children’s Hospital located on the St. James’s campus in Dublin. This is a voluntary ex ante transparency (VEAT) notice. This notice acknowledges that CHI proposes to contract with a specialist company for the Commissioning, Qualification and Validation (CQV) services, as described herein. These are specialist CQV services applying to all facilities in the Micro Lab (Microbiology, incl. Molecular), with particular attention to Mass Spec, Tissue Culture, PCR (qPCR and next-generation sequencing, NGS), Stem Cell HSCT Cleanrooms and Biosafety BSL3 Labs. CQV services for the new facilities include supporting technical submission evaluations, witnessing and assessment of specialist commissioning test protocols and commissioning activities, along with performance verification and acceptance, and finally alignment to regulatory guidelines, European and international standards. Transition services include support of migration and transfer planning, transfer protocols, risk mitigation strategies, transport logistics, coordination, training, ongoing qualification, and start-up and “GO LIVE”, through the first year of sustainable operations. The installation of new specialist lab facilities, along with the migration, transition and relocation of multiple live paediatric services into a single large scale national children’s hospital is unprecedented in Ireland and presents significant clinical, logistical, and operational risk. The start-up and transition to the new children’s hospital involves critical, time dependent, safety sensitive operations where failure or disruption may impact patient care and national paediatric acute services. Due to the significant operational and clinical risk, CHI requires a CQV service provider with a demonstrated track record of delivering similar complex projects with zero service downtime and assured continuity of care. The project requires a service provider with deep, demonstrable, and specialised expertise in specialist complex technical regulated projects including migration, transitioning and relocation of existing services in “GO LIVE” and sustained operations during the first year. The name of the proposed contractor is 3dimension Cleanrooms Limited (3di CRs). CHI has identified 3di CRs as the only provider able to meet the unique combination of scale, complexity, and specialist expertise required for this project. 3di CRs has over 40 years in the Cleanroom and Biosafety industry, with over 20 years of writing ISO and CEN standards, writing User Requirements Specifications, oversight on behalf of User Groups on the installation of new facilities, Commissioning and Performance verification of complex Life Science and Healthcare facilities, as well as the migration, transitioning and start-up of existing services to new facilities. CHI are satisfied that there is no other provider that possesses comparable specialist CQV capabilities or equivalent experience of Cleanroom and Biosafety related hospital services and regulatory requirements, at this scale, risk level, and technical complexity. This VEAT notice acknowledges that CHI proposes to contract with 3di CRs for the provision of the above CQV services.

Specialist Technical Expert Commissioning and Qualification Support Services for new specialist facilities, and Transition of existing services, to the new children’s hospital, Dublin, Ireland

Children’s Health Ireland (CHI) is investing in new services and consolidating paediatric services from its existing acute sites in Dublin (Crumlin, Temple Street, and paediatric services at Tallaght) into the new purpose‑built Children’s Hospital located on the St. James’s campus in Dublin. This is a voluntary ex ante transparency (VEAT) notice. This notice acknowledges that CHI proposes to contract with a specialist company for the Commissioning, Qualification and Validation (CQV) services, as described herein. These are specialist CQV services applying to all facilities in the Micro Lab (Microbiology, incl. Molecular), with particular attention to Mass Spec, Tissue Culture, PCR (qPCR and next-generation sequencing, NGS), Stem Cell HSCT Cleanrooms and Biosafety BSL3 Labs. CQV services for the new facilities include supporting technical submission evaluations, witnessing and assessment of specialist commissioning test protocols and commissioning activities, along with performance verification and acceptance, and finally alignment to regulatory guidelines, European and international standards. Transition services include support of migration and transfer planning, transfer protocols, risk mitigation strategies, transport logistics, coordination, training, ongoing qualification, and start-up and “GO LIVE”, through the first year of sustainable operations. The installation of new specialist lab facilities, along with the migration, transition and relocation of multiple live paediatric services into a single large scale national children’s hospital is unprecedented in Ireland and presents significant clinical, logistical, and operational risk. The start-up and transition to the new children’s hospital involves critical, time dependent, safety sensitive operations where failure or disruption may impact patient care and national paediatric acute services. Due to the significant operational and clinical risk, CHI requires a CQV service provider with a demonstrated track record of delivering similar complex projects with zero service downtime and assured continuity of care. The project requires a service provider with deep, demonstrable, and specialised expertise in specialist complex technical regulated projects including migration, transitioning and relocation of existing services in “GO LIVE” and sustained operations during the first year. The name of the proposed contractor is 3dimension Cleanrooms Limited (3di CRs). CHI has identified 3di CRs as the only provider able to meet the unique combination of scale, complexity, and specialist expertise required for this project. 3di CRs has over 40 years in the Cleanroom and Biosafety industry, with over 20 years of writing ISO and CEN standards, writing User Requirements Specifications, oversight on behalf of User Groups on the installation of new facilities, Commissioning and Performance verification of complex Life Science and Healthcare facilities, as well as the migration, transitioning and start-up of existing services to new facilities. CHI are satisfied that there is no other provider that possesses comparable specialist CQV capabilities or equivalent experience of Cleanroom and Biosafety related hospital services and regulatory requirements, at this scale, risk level, and technical complexity. This VEAT notice acknowledges that CHI proposes to contract with 3di CRs for the provision of the above CQV services.