NHS eprocurement strategy

Transcription

1 Date: July 2017 NHS eprcurement strategy Update This update clarifies a number f areas that have been subject t discussin ver recent mnths relating t implementatin f the NHS eprcurement strategy (als knwn as Scan4Safety). NHS acute trusts, suppliers t the NHS, and technlgy prvider rganisatins shuld all be aware f, and act upn, the cntent f this update, which cvers the fllwing tpics: Master data exchange; EU Medical Device and In-Vitr Diagnstic Device timelines; PEPPOL guidance dcumentatin and purchase rder messages; PEPPOL Access Pint services - cmmercial mdel; Publicatin cycle fr future updates n the eprcurement Strategy. Master data exchange 1. Cntext The update n master data exchange adds t the fllwing previusly published dcumentatin n this tpic that can be fund in the DH exchange Library: NHS eprcurement Strategy eprcurement Update March 2016 MDE Demnstratin f Technlgy Case Study MDE Demnstratin f Technlgy Participant Feedback Master Data Exchange Industry Cnsultatin 2. Backgrund The NHS eprcurement strategy identified that the use f master data thrughut the supply chain, bth within and utside hspitals, is essential t supprt supply chain efficiency and patient safety. The Department f Health (DH) requires NHS trusts and their suppliers t adpt GS1 standards fr the cding f prducts and fr the structuring f master data attributes that are assciated t a specific prduct. Page 1 f 7

2 NHS eprcurement strategy 3. Data requirements DH will publish Data Dictinaries and supprting Supplier Manuals fr five expenditure categries, each setting ut the specific requirements fr that categry: Medical and In Vitr Diagnstic Devices (already published); Medicines (in cnsultatin phase); Office and IT prducts (in cnsultatin phase); Estates and Facilities prducts; Services. The Data Dictinaries cntain the technical detail f each data attribute required frm suppliers fr each prduct and service they sell t the NHS and the Supplier Manuals will prvide categry specific guidance in supprt f each data attribute. All suppliers t the NHS must cnfrm t the requirements set ut in these Data Dictinaries and the Master Data Exchange Guidance dcument in line with published timelines. The data attributes cntained within the Data Dictinaries will be specified as either: Mandatry, r Cnditinal mandatry, r Optinal. Mandatry data attributes are thse that must be prvided; cnditinal mandatry data attributes must be prvided if they are relevant t a given scenari fr the specific prduct (fr example a cntract reference nly needs t be prvided if a cntract exists); and ptinal data attributes can be prvided if the supplier chses t prvide them. 4. Data sharing Once a supplier has cded a prduct and identified the data attributes that relate t that prduct cde, this frms the master data that then needs t be shared electrnically with NHS trusts. T enable this electrnic exchange, suppliers are required t place their master data in a GS1-certified datapl that is part f the GS1 Glbal Data Synchrnisatin Netwrk (GDSN), a list f which is available n the GS1 website. Only master prduct data is currently in scpe fr exchange via GDSN. Price data is nt currently in scpe fr exchange via GDSN, but DH is currently cnsidering ptins fr the exchange f price data and will prvide a further update in due curse. 5. Pilt In cnjunctin with the NHS Business Services Authrity (BSA) and NHS Supply Chain (NHSSC), DH is pilting a master data validatin and sharing service. This service will receive master prduct data frm GS1 datapls via GDSN; validate and quality cntrl the data against DH published Data Dictinaries; and exchange prduct data electrnically with NHS trusts directly r via apprved intermediary technlgy prvider rganisatins. Page 2 f 7

3 NHS eprcurement strategy The scpe f the pilt will be limited t the six NHS Scan4Safety Demnstratr Sites; thse suppliers that are currently cmpliant with the DH supplier cmpliance timeline fr Medical and In Vitr Devices; thse prducts that are currently supplied via NHSSC; and will utilise the existing electrnic cnnectins with the NHSSC catalgue. This pilt is part f the develpment f the future steady-state slutin and updates n prgress will be prvided ver the cming mnths. 6. Cmmercial mdel T ensure that the benefits f high quality master data are maximised, the current and future directin requires interperability between the NHS and its supplier base thrugh intermediary technlgy service prviders, within a multi-vendr envirnment. A key principle f this envirnment is that NHS trusts and suppliers shuld each pay fr the technlgy services that they cnsume. Csts attributable t NHS trusts fr prduct and price data exchange shuld nt be passed n t suppliers, r vice versa. Whilst we wrk tward the steady-state slutin, NHS trusts and suppliers shuld cntinue t make their wn cmmercial arrangements fr catalgue services fr the exchange f prduct and price data, within the key principle utlined abve. Impact f EU UDI legislatin n the Medical and IVD Device supplier timeline 1. Cntext The update n the supplier timeline adds t the fllwing previusly published dcumentatin n this tpic that can be fund in the DH exchange Library: Medical and In-Vitr Diagnstic Device Supplier Timeline 2. Backgrund EU UDI legislatin, mre prperly the EU Medical Device Regulatin (MDR) and In-Vitr Diagnstic Device Regulatin (IVDR), was published in the Official Jurnal f the Eurpean Unin in May Labelling clarificatin The EU UDI legislatin indicates that all Class I and Class IIa medical devices shall carry a unique identifier label n the packaging at the level abve unit f use, whereas the DH timeline indicates that Class IIa medical devices shall carry a unique identifier label at the unit f use level. DH will issue an amended timeline t harmnise with the EU labelling requirement fr Class IIa medical devices. Page 3 f 7

4 NHS eprcurement strategy 4. Timeline clarificatin The DH timeline states that, in the event that EU UDI legislatin cmes int frce with dates that differ with thse required by the timeline dcument in the previus sectin, the dates will be amended t match the legislated timelines. Hwever, after review f the dates required by the EU UDI legislatin, DH has decided that dates specified in the DH timeline will remain unchanged, fr the fllwing reasns: EU regulatins have taken lnger t cme int frce than previusly anticipated This has resulted in a timeline that lags several years behind the requirements f the NHS eprcurement strategy. Fr example, the EU regulatin requires a UDI t be assigned t Implantable and Class III medical devices three years and eight mnths after the DH timeline requirement fr GTIN allcatin. DH des nt want t disadvantage suppliers that are meeting the DH timeline The latest rund f supplier self-declaratins shws that 66 suppliers (cllectively representing 25% f in-categry expenditure) are fully cmpliant with the March 2017 DH timeline requirements. This is a great achievement by thse suppliers, shwing the level f cmmitment that has already been delivered. Delaying adptin t harmnise with the MDR/IVDR timelines will devalue this cmmitment. US Fd and Drug Administratin deadlines are in advance f the EU deadlines T meet US FDA requirements, suppliers t the NHS that als trade in the US are already taking many f the necessary actins required by MDR and IVDR, well in advance f the EU timelines. DH requirements that are cmmn t FDA requirements are set several years later than the FDA. Fr example, DH labelling and data requirements fr Class III medical devices are set at fur years after the FDA equivalent requirement. Benefits The DH timeline requirements, bth UDI-related and mre widely, are designed t imprve patient safety and security in the NHS, whilst simultaneusly realising supply chain efficiencies fr bth the NHS and its suppliers. It is nt in the interest f patients, hspitals r suppliers t delay the realisatin f these benefits. 5. Medicines and Healthcare prducts Regulatry Agency (MHRA) The MHRA is a public health rganisatin with a fcus n patient safety thrugh its rle as regulatr f medicines, medical devices and bld cmpnents fr transfusin in the UK and is the Cmpetent Authrity respnsible fr implementatin f the EU UDI legislatin (MDR/IVDR) in the UK. MHRA has expressed its supprt fr the apprach utlined abve. Page 4 f 7

5 NHS eprcurement strategy PEPPOL guidance dcumentatin and purchase rder message 1. Cntext The update n PEPPOL guidance adds t the fllwing previusly published dcumentatin n this tpic that can be fund in the DH exchange Library: Guidance Registratin f PEPPOL Capability PEPPOL Demnstratin f Technlgy Case Study 2. Backgrund T ensure cnsistent applicatin f PEPPOL and the interperability f Access Pint prviders within a fur-crner mdel, DH has published a PEPPOL Guidance Manual and a set f PEPPOL Data Dictinaries. These dcuments are available in the DH exchange Library. This new suite f dcuments was prduced with input frm industry and is intended t supprt a faster and mre cnsistent take-up f PEPPOL in the NHS. 3. Order Respnse message With publicatin f the PEPPOL Guidance Manual and Data Dictinaries, DH requires suppliers t acknwledge purchase rders acrss the PEPPOL netwrk by sending Order Respnse messages. Suppliers are free t wrk with their chsen Access Pint prviders t establish a cmmn and repeatable methd t send rder respnses, using the PEPPOL BIS 28A Order and Order Respnse message type. DH acknwledges that this is a new requirement, which has been added as a result f feedback n hw best t increase the vlume f healthcare business transactins acrss the PEPPOL netwrk. With this step, we are adding an additinal level f certainty and cnfidence t the PEPPOL netwrk. 4. Timeline The DH will amend the Supplier Cmpliance Timeline fr Medical and In Vitr Devices t incrprate this requirement t be implemented by March 2018, althugh suppliers are encuraged t implement as sn as pssible. Page 5 f 7

6 NHS eprcurement strategy PEPPOL Access Pint services - cmmercial mdel 1. Cntext All NHS trusts and suppliers are required t utilise the services f a PEPPOL access pint thereby establishing the PEPPOL 'fur-crner' mdel fr the electrnic machine-tmachine exchange f purchase rders and invices, tgether with related message types. The infrmatin belw respnds t requests frm suppliers fr greater infrmatin and guidance n the cmmercial implicatin invlved in prcuring a PEPPOL access pint. This dcument prvides generalised indicative pricing frm the framewrk agreement t aid suppliers in assessing csts submitted by PEPPOL access pint service prviders. 2. Backgrund The Crwn Cmmercial Service (CCS) has set up a framewrk agreement fr the prvisin f PEPPOL access pint services. The agreement is available t all public sectr bdies in the UK, including NHS trusts, wh are able t make a direct award t their preferred service prvider, using the terms and cnditins f the framewrk agreement. Suppliers are able t select any PEPPOL-certified access pint service prvider listed n the OpenPEPPOL website: Suppliers will make their wn arrangements with the PEPPOL access pint service prvider f their chice. 3. Indicative fee structures Fees fr PEPPOL access pint services typically cmprise the fllwing elements: Annual subscriptin fee Subscriptin fees are typically in the lw 1,000s per year, althugh there can be significant variatin between vendrs. Suppliers are advised t cmpare ptins. Charge per transactin Transactin charges (either t send a message, receive a message, r bth) are typically in the rder f 'pence' per transactin, althugh there can be significant variatin in charges. Suppliers are advised t cmpare ptins. Additinal services Day rates may be charged t cver ne-ff implementatin csts fr prject implementatin; dcument mapping; technical expertise; and prcess testing. 3. Disclaimer The abve indicative fees are fr infrmatin nly and are based n the CCS framewrk. Detail differences between cmmercial mdels fr NHS trusts and suppliers are likely. Page 6 f 7

7 NHS eprcurement strategy Future publicatin cycle 1. Cntext The update n the future publicatin cycle adds t the fllwing previusly published dcumentatin n this tpic that can be fund in the DH exchange Library: eprcurement update, March Backgrund The DH exchange wrkspace cntinues t prvide a rapid and effective mechanism fr highlighting questins and answers t clarify DH requirements. Hwever, we als need t ensure that significant clarificatins are frmally recrded, and made accessible fr reference by all cmmunities f interest. 3. Frmal updates This July 2017 update fllws the first update that was issued in March Frm nw n, DH will use this update frmat n a set cycle t prvide stability and certainty t all parties invlved in implementatin f the NHS eprcurement strategy. DH will publish updates twice yearly, in April and in Octber. By publishing in these mnths, we can harmnise with the rta fr industry self-declaratins (pen in March and September) and include the results f the self-declaratin exercises in each update. If extrardinary circumstances arise and frmal cmmunicatins are required between these publicatin windws, DH will publish updates and clarificatins as required. 4. Register T jin the DH exchange wrkspace, please request access by t: eprcurement@dh.gsi.gv.uk Page 7 f 7