Mae gwerthwchigymru.llyw.cymru yn defnyddio cwcis sy'n hanfodol er mwyn i'r safle weithio. Rydym hefyd yn defnyddio cwcis nad ydynt yn hanfodol i'n helpu i wella gwasanaethau digidol y Llywodraeth. Mae unrhyw ddata a gesglir yn ddienw. Drwy barhau i ddefnyddio'r safle hwn, rydych yn cytuno i'n defnydd o gwcis

Derbyn ein defnydd o gwcis Gosodiadau cwcis

Gweld Hysbysiad

Nid yw'r prynwr yn defnyddio'r wefan hon i weinyddu'r hysbysiad. I gofnodi eich diddordeb neu gael gwybodaeth neu ddogfennau ychwanegol, darllenwch y cyfarwyddiadau yn Nhestun Llawn yr Hysbysiad. (NODER: Nid oes angen ymateb i Hysbysiadau Dyfarnu Contractau a Hysbysiadau Gwybodaeth Ymlaen Llaw fel arfer)

Ychwanegu hysbysiad at fy Rhestr Diddordeb

Manylion yr Hysbysiad

Teitl: EQA for the National Genomic Test Directory
Cyhoeddwyd gan: NHS England
Dyddiad Cyhoeddi: 13/10/21
Dyddiad Cau:
Amser Cau:
Math o Hysbysiad: Dyfarnu Contract
Yn Cynnwys Dogfennau: Na
Yn ESPD: Na
Crynodeb:

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

Hysbysiad dyfarnu contract

Canlyniadau'r weithdrefn gaffael

Cyfarwyddeb 2014/24/EU - Cyfarwyddeb y Sector Cyhoeddus

Cyfarwyddeb 2014/24/EU

Adran I: Endid contractio

I.1) Enw a chyfeiriad

NHS England

Quarry House

Leeds

LS2 7UE

UK

Person cyswllt: Anita Pannu

E-bost: anita.pannu@nhs.net

NUTS: UKE

Cyfeiriad(au) rhyngrwyd

Prif gyfeiriad: https://www.england.nhs.uk//

Cyfeiriad proffil y prynwr: https://www.england.nhs.uk//

I.4) Y math o awdurdod contractio

Corff a lywodraethir gan gyfraith gyhoeddus

I.5) Prif weithgaredd

Iechyd

Adran II: Gwrthrych

II.1) Cwmpas y caffaeliad

II.1.1) Teitl

EQA for the National Genomic Test Directory

Cyfeirnod: C30160

II.1.2) Prif god CPV

85100000

 

II.1.3) Y math o gontract

Gwasanaethau

II.1.4) Disgrifiad byr

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).

II.1.6) Gwybodaeth am lotiau

Mae’r contract hwn wedi’i rannu’n lotiau: Na

II.1.7) Cyfanswm gwerth y caffaeliad

Gwerth heb gynnwys TAW: 1 500 000.00 GBP

II.2) Disgrifiad

II.2.3) Man cyflawni

Cod NUTS:

UKI


Prif safle neu fan cyflawni:

NHS England

II.2.4) Disgrifiad o’r caffaeliad

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

II.2.5) Meini prawf dyfarnu

Price

II.2.11) Gwybodaeth am opsiynau

Opsiynau: Na

II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd

Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd: Na

Section IV: Gweithdrefn

IV.1) Disgrifiad

IV.1.1) Y math o weithdrefn

Dyfarnu contract heb gyhoeddi galwad am gystadleuaeth yng Nghyfnodolyn Swyddogol yr Undeb Ewropeaidd ymlaen llaw

Cyfiawnhau'r weithdrefn ddyfarnu a ddewiswyd:

Dim ond am y rheswm canlynol y gall gweithredwr economaidd penodol ddarparu'r gwaith, y cyflenwadau neu'r gwasanaethau: diffyg cystadleuaeth am resymau technegol

Esboniad

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/

IV.1.8) Gwybodaeth am Gytundeb Caffael y Llywodraeth (GPA)

The procurement is covered by the Government Procurement Agreement: Na

Section V: Dyfarnu contract

Dyfernir contract/lot: Ydy

V.2 Dyfarnu contract

V.2.1) Y dyddiad y daeth y contract i ben

13/07/2021

V.2.2) Gwybodaeth am dendrau

Nifer y tendrau a ddaeth i law: 1

Nifer y tendrau a ddaeth i law gan BBaChau: 0

Nifer y tendrau a dderbyniwyd gan dendrwyr o Aelod-wladwriaethau yr UE: 0

Nifer y tendrau a dderbyniwyd gan dendrwyr o Aelod-wladwriaethau nad ydynt yn aelodau o'r UE: 0

Nifer y tendrau a ddaeth i law drwy ddulliau electronig: 0

Dyfarnwyd y contract i gr?p o weithredwyr economaidd: Na

V.2.3) Enw a chyfeiriad y contractwr

Lothian Health Board

Waverly Gate 2nd Floor 2-4 Waterloo PLace Edinburgh

Edinburgh

EH1 3EG

UK

E-bost: accountsreceivable@nhslothian.scot.nhs.uk

NUTS: UKM

Cyfeiriad(au) rhyngrwyd

URL: https://www.nhslothian.scot/Pages/default.aspx

BBaCh yw’r contractwr: Ydy

V.2.4) Gwybodaeth am werth y contract/lot (heb gynnwys VAT)

Amcangyfrif cychwynnol o gyfanswm gwerth y contract/lot: 1 500 000.00 GBP

Cyfanswm gwerth y contract/lot: 1 500 000.00 GBP

V.2.5) Gwybodaeth am is-gontractio

Section VI: Gwybodaeth ategol

VI.3) Gwybodaeth ychwanegol

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.

VI.4) Gweithdrefnau adolygu

VI.4.1) Corff adolygu

NHS England

Skipton House, 80 London Road

London

SE1 6LH

UK

Cyfeiriad(au) rhyngrwyd

URL: https://www.england.nhs.uk//

VI.4.2) Corff sy’n gyfrifol am weithdrefnau cyfryngu

NHS England

Skipton House, 80 London Road

London

SE1 6LH

UK

Cyfeiriad(au) rhyngrwyd

URL: https://www.england.nhs.uk//

VI.4.4) Y gwasanaeth lle y gellir cael gwybodaeth am y weithdrefn adolygu

NHS England

Quarry House

Leeds

LS2 7UE

UK

Cyfeiriad(au) rhyngrwyd

URL: https://www.england.nhs.uk//

VI.5) Dyddiad anfon yr hysbysiad hwn

12/10/2021


Gwybodaeth a ychwanegwyd at yr hysbysiad ers iddo gael ei gyhoeddi.

Additional information added to the notice since it's publication.
Nid oes unrhyw wybodaeth bellach wedi'i lanlwytho.
Prif Gyswllt: anita.pannu@nhs.net
Cyswllt Gweinyddol: Dd/g
Cyswllt Technegol: Dd/g
Cyswllt Arall: Dd/g

Categorïau Nwyddau

Commodity Categories
Rhif AdnabodTeitlPrif Gategori
85100000Health servicesHealth and social work services

Lleoliadau Dosbarthu

Delivery Locations
Rhif AdnabodDisgrifiad
100DU - Holl

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