Section one: Contracting authority
one.1) Name and addresses
NHS England
Quarry House
Leeds
LS2 7UE
Contact
Anita Pannu
Country
United Kingdom
NUTS code
UKE - Yorkshire and the Humber
Internet address(es)
Main address
Buyer's address
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
EQA for the National Genomic Test Directory
Reference number
C30160
two.1.2) Main CPV code
- 85100000 - Health services
two.1.3) Type of contract
Services
two.1.4) Short description
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).
two.1.6) Information about lots
This contract is divided into lots: No
two.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: £1,500,000
two.2) Description
two.2.3) Place of performance
NUTS codes
- UKI - London
Main site or place of performance
NHS England
two.2.4) Description of the procurement
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
two.2.5) Award criteria
Price
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Award of a contract without prior publication of a call for competition in the cases listed below
- The services can be provided only by a particular economic operator for the following reason:
- absence of competition for technical reasons
Explanation:
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:https://www.ukas.com/browse-ukas-accredited-organisationsThe 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 – https://www.genqa.org/UK NEQAS Leucocyte Immunophenotyping - http://www.ukneqasli.co.uk/UK NEQAS Haematology – https://www.ukneqash.org/
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: No
Section five. Award of contract
A contract/lot is awarded: Yes
five.2) Award of contract
five.2.1) Date of conclusion of the contract
13 July 2021
five.2.2) Information about tenders
Number of tenders received: 1
Number of tenders received from SMEs: 0
Number of tenders received from tenderers from other EU Member States: 0
Number of tenders received from tenderers from non-EU Member States: 0
Number of tenders received by electronic means: 0
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor
Lothian Health Board
Waverly Gate 2nd Floor 2-4 Waterloo PLace Edinburgh
Edinburgh
EH1 3EG
accountsreceivable@nhslothian.scot.nhs.uk
Country
United Kingdom
NUTS code
- UKM - Scotland
Internet address
https://www.nhslothian.scot/Pages/default.aspx
The contractor is an SME
Yes
five.2.4) Information on value of contract/lot (excluding VAT)
Initial estimated total value of the contract/lot: £1,500,000
Total value of the contract/lot: £1,500,000
Section six. Complementary information
six.3) Additional information
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.
six.4) Procedures for review
six.4.1) Review body
NHS England
Skipton House, 80 London Road
London
SE1 6LH
Country
United Kingdom
Internet address
six.4.2) Body responsible for mediation procedures
NHS England
Skipton House, 80 London Road
London
SE1 6LH
Country
United Kingdom
Internet address
six.4.4) Service from which information about the review procedure may be obtained
NHS England
Quarry House
Leeds
LS2 7UE
Country
United Kingdom