Official UK procurement notice
EQA for the National Genomic Test Directory
Authority: NHS England (Central government)
What is being bought
Published requirement descriptionThis procurement relates to external quality assurance of the samples and the DNA material taken at NHS Genomic Laboratory Hubs as part of the new Genomic Medicine Service. Such sequencing requires high quality DNA and to ensure these samples are provided by the NHS Genomic Medicine Centres (GMCs), a range of external quality assessment (EQA) schemes are required. An assured lab network of GLHs will provide the required assurance to the wider GMS (including for clinical genetics services and Genomic Medicine Centres established as part of the 100,000 Genomes Project).
CPV: Health services
The lotProcurement structure
single lot · no lot value publishedLot #1Building on the 100,000 Genomes Project and existing genetic services, In October 2018…Awarded
Building on the 100,000 Genomes Project and existing genetic services, In October 2018 NHS England announced the launch of the NHS Genomic Medicine Service (GMS) which will be mobilised as part of a transition period to take place over 18 months. The long term aims of the Genomic Medicine Service are to: o Provide consistent and equitable care for England’s 55 million populationo Operate to common national standards, specifications and protocols o Deliver to a single national genomic testing directory – covering use of all technologies from single gene to whole genome sequencing initially for rare disease and cancero Give all patients the opportunity to participate in research (for individual benefit and to inform future care)o Build a national genomic knowledge base providing real world data This procurement relates to external quality assurance of the samples and the DNA material taken at NHS Genomic Laboratory Hubs as part of the new Genomic Medicine Service. Such sequencing requires high quality DNA and to ensure these samples are provided by the NHS Genomic Medicine Centres (GMCs), a range of external quality assessment (EQA) schemes are required. An assured lab network of GLHs will provide the required assurance to the wider GMS (including for clinical genetics services and Genomic Medicine Centres established as part of the 100,000 Genomes Project). The quality assurance measures are concentrated on 5 major areas below. NHS England are obligated to provide a quality assurance service to ensure samples collected are of high enough quality to extract a full genome.The required EQA service is as follows:
- EQA for DNA extraction from blood samples
- EQA for DNA extraction for formalin fixed paraffin embedded (FFPE) tissue samples
- EQA for the measurement of DNA quality
- EQA for the assessment of tumour content and cellularity
- EQA for the National Genomic Testing Directory
Procedure terms & legal framework
From the official record · publisher note attached- Procedure method
- Award procedure without prior publication of a call for competition
- Legal basis
- CELEX · 32014L0024 Public Contracts Regulations 2015 (Directive 2014/24/EU)
- Procurement category
- Services
- Notice status
- Awarded without competition
- Procurement threshold
- Unspecified in notice
- Regulatory regime
- Standard
- Commercial structure
- Stand-alone contract (no framework)
- Competition type
- Direct award (no call for competition)
- GPA / WTO covered
- Unspecified in notice
- Recurring procurement
- Unspecified in notice
- First published
- 12 Oct 2021, 15:50 BST
- Last source update
- 12 Oct 2021, 15:50 BST
- Authority reference
C30160- FTS notice number
2021/S 000-025500- Classification (CPV)
- Delivery area
- Official registry OCID
ocds-h6vhtk-02eb09Find a Tender
- Why no open competition
The works, supplies or services can be provided only by a particular economic operator due to absence of competition for technical reasons
- Published justification
A full list of the UKAS accredited suppliers able to provide a quality assurance service for the testing of DNA samples can be found here:www.ukas.com/browse-ukas-accredit… ↗ NHS England Genomics Unit has assessed the UKAS-accredited supplier market by use of the link above to identify which are able to meet the service requirements. Based on this assessment, the Genomics Unit has ascertained that:
- UK NEQAS (hosted by NHS Lothian) are the only provider qualified and ISO17043 or equivalent accredited for the DNA extraction EQA schemes and related molecular pathology schemes as described above;
- No other single provider has the ability to provide the range of medical laboratory tests across Haematology, Blood Coagulation, Immunophenotyping and Histocompatibility and Immunogenetics disciplines. The list of centres with their corresponding EQAs listed can be accessed here Centres - UK NEQAS. The UK NQEAS centres involved are:GenQA/UK NQEAS Genomics – www.genqa.org/UK ↗ NEQAS Leucocyte Immunophenotyping - www.ukneqasli.co.uk/UK ↗ NEQAS Haematology – www.ukneqash.org ↗
Publisher note: The required EQA services are as follows and are all mandatory as part of the contract:• Annual provision of the tests listed in the National Genomic Testing Directory which will be implemented during the transition phase of the Genomic Medicine Service• Annual provision of one assessment run for DNA extraction from blood samples• Annual provision of one assessment run for DNA extraction from FFPE tissue samples• Annual provision of one assessment run for DNA extraction from fresh frozen tissue samples• Annual provision of one assessment run for DNA extraction from saliva tissue samples• Annual provision of one assessment run for tissue histopathology assessments• Annual provision of one assessment run for DNA quality measurement• Capability to develop other EQAs for any other aspect of laboratory work involved delivery of whole genome sequencing of clinical samples.• Evidence of scientific advice appropriate to these EQA schemes.• Delivery of these EQA schemes to all laboratories deemed appropriate by NHS England including Genomic Laboratory Hubs and associated Local Genomic Laboratories.• Established process for independent, anonymised assessment of results and unbiased reporting of participant performance against NHS England ratified criteria and integration into appropriate National Quality Assurance Advisory Panels.• Ability to interact with participants with performance issues and support the identification of the causative issues and aid improvement; including the monitoring of the participant in future EQA runs.The output from the above is to ensure NHS England is assured that the DNA material collected by NHS laboratories is fit for purpose and the genomic tests performed are accurate and appropriately reported. Without a Quality Assurance service in place there is a high risk of NHS GLHs being regularly paid for samples and tests of sub-standard quality leading to an unachievable genomic testing for the NHS. Laboratory work undertaken as part of the NHS Genomic Medicine Service must be covered by the industry standard - ISO 17043 for the appropriate EQA schemes. UK National External Quality Assessment Service (UK NEQAS) consortium member.
Commercial outcome & contract awards
Published awards, contracts and bid statistics, not a forecast| Awarded to | Value | Date | Status |
|---|---|---|---|
| Lothian Health Board | £1,500,000 † | — | Awarded |
Contracts
Contract 025500-2021-1 · Lothian Health Board
- Signed
- 13 Jul 2021
- Value
- £1,500,000
- Status
- active
Bid statistics published by the authority
| Bids | SME | VCSE | Valid bid range |
|---|---|---|---|
| 1bids · 0 electronic | 0 | — | — |
Contracting authority & participating public bodies
Bidders & participating suppliers
1 commercial party on the notice- Lothian Health BoardAwarded supplier
Official documents & specifications
Official links; attachments are not copiedNo document links were published on the notice.