Workflow for NHS Labs delivering SCID and SMA ISEs (ENLITE Methodology)

This is a Provider Selection Regime (PSR) Intention-to-Award Notice.<br/><br/>This notice is subject to Regulation 10 of the Health Care Services (Provider Selection Regime) Regulations 2023.<br/><br/>For the avoidance of doubt, this is not a procurement via PA23 or PCR 2015.<br/><br/>This is a notice of intention to make an award to one provider in respect of the Service pursuant to the Direct Award C process via PSR for the services of ENLITE Methodology Screening Labs, as part of the delivery and implementation of the ongoing NHS Newborn Blood Spot in-service evaluation (ISE) for Severe Combined Immuno-Deficiency (SCID), with the addition of the ISE for Spinal Muscular Atrophy (SMA), as recommended by the UK NSC.<br/><br/>This is an intention to award notice. A notice of the confirmation of the award of each contract will be issued once they are signed.<br/><br/>Pursuant to the NHS Newborn Blood Spot in-service evaluation (ISE) for Severe Combined Immuno-Deficiency (SCID) contracts, with the addition of the ISE for Spinal Muscular Atrophy (SMA), the providers are to provide the following functions:<br/><br/>• Specialist scientific and clinical workforce required to deliver assurance, quality oversight, and programme reporting.<br/>• Laboratory capacity and turnaround requirements to support in‑service evaluation activity alongside existing SCID delivery.<br/>• Quality assurance and quality control processes, including maintenance of consistent methodologies, validation status, and reporting standards.<br/>• Information governance, data management, and secure data flows required to support national screening evaluation and reporting.<br/>• Programme management and coordination activity necessary to support continuity and comparability of in‑service evaluation outputs.