Laboratory reagents

Tender description

NHS Wales Shared Services Partnership, on behalf of Cardiff and Vale University Health Board wish to inform the market that they intend to award a 3-year contract from the 1.7.2019 for the supply of Non Invasive Pre-natal Testing (NIPT) reagents to Illumina Cambridge Limited. In January 2016 the UK National Screening Committee (UK NSC) recommended a 3-year evaluative implementation of NIPT as a contingency test following a positive antenatal screening result for Down/Edwards/Patau syndromes. In response to this the Welsh Government (WG) asked Public Health Wales (PHW) to scope and take forward the introduction of NIPT within the NHS antenatal screening programme in Wales. The introduction of NIPT within the Screening for Down’s, Edwards’ and Patau’s antenatal programme was implemented from 30.4.2018 following a full tender exercise where Illumina were subsequently awarded a 3-year contract. The data collection for the UK NSC evaluative programme has began and will be presented to the evaluation board in due course. These are reasons why a change in supplier at this point would be disadvantageous for this project: 1) The implementation of NIPT is a 3-year evaluative roll out. Consistency in NIPT service provision is key to evaluate the data at the end of the national project. A change in supplier would impact on this consistency as other suppliers platforms differ both the wetwork (platforms for testing differ) and more importantly how the data is generated and analysed; 2) A change in supplier would also mean re-validation of that test within the laboratory. Re-validation of a new assay will mean: (a) disruption to the current NIPT service provision, resulting from re-validation of the assay. There is a patient safety issue with the NIPT being safer than the invasive amniocentesis/chorionic villus sampling, which would be necessary in the event of re-validation. There is a miscarriage risk with this invasive testing, (b) financial risk. Re-validation would cost in consumables, staff time and potentially equipment. There would be a requirement to run any replacement protocols in duplicate to ensure consistency and equivalency in results, (c) financial risk. There is a clear financial risk with changing platforms at this time. Currently the laboratory has five Illumina based sequencing platforms, and all bioinformatic pipelines for other key services rely on this continuing, there would be a significant additional cost in restructuring this, both in additional equipment and staff time; 3) Patient impact. The introduction of NIPT to the current screening pathway has significantly reduced the number of amniocentesis procedures performed for higher chance screening results (300 in 6 months). The benefit of this will be a reduction in the number of procedure related miscarriages. Any disruption to the current NIPT service provision will have a significant impact to pregnancy care; 4) Financial risk. Disruption to the current NIPT service provision will have a significant financial impact due to the requirement for the screening programme to provide this test to pregnant women and will therefore require to send the test to providers outside of Wales at a premium cost; 5) Increase in invasive procedures: Obstetric/Foetal medicine services — there is likely to be an increase in the number of invasive diagnostic procedures undertaken within the proposed antenatal screening programme for Down’s, Edwards’ and Patau’s syndrome, if there is any disruption in the NIPT service. This will increase demand for invasive procedure capacity; 6) Service Stability. AWMGS have proven evidence of success with Illumina NIPT platform. Resulting in a reliable service to pregnant women and to the ASW screening programme. AWMGS staff are confident with handling the protocol, processes, troubleshooting which would inevitably be disrupted and cost the service. In addition to the above, disruption in the provision of NIPT at the All Wales Genetics Laboratory will negatively affect the reputation of the laboratory where Wales will not be compliant with UK NSC recommendations.