Complexities and capabilities of Scan4Safety in NHS hospitals: a qualitative study of a national demonstrator site

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Abstract Background: Data standards and barcoding technologies are implemented in hospitals to uniquely identify objects, people and locations, streamline the management of supplies and inventories, improve efficiency, reduce waste and improve patient safety and quality of care. The UK Department of Health & Social Care Scan4Safety demonstrator programme (2016-2019) had six hospitals adopt global data standards to address these aims. This study examined the implementation of Scan4Safety at one NHS demonstrator site to understand the hospital experience of adopting these standards, barcoding and related technologies. Methods: Exploratory case study design, informed by information infrastructure theory, at one Scan4Safety demonstrator site. Semi-structured interviews were conducted with internal and external stakeholders, analysed thematically together with thematic analysis of documents related to the Scan4Safety programme. Results: The NHS Trust Scan4Safety team was interviewed, together with senior roles in procurement, inventory, recalls management, nurses and surgeons (n=15), and senior roles in other demonstrator sites, NHS supplies, as well as GS1 - the organization responsible for the standards (n=4); 67 documents were analysed. Key enablers for Scan4Safety included: allocated funding, government role/regulation, executive buy-in/wide stakeholder involvement, patient focus, agile/adaptive approach and data linkage. Challenges were both internal and external, mainly pertaining to data quality, work-as-done, and trade-offs. Mechanisms of anticipated positive outcomes, and potential risks were also identified. Conclusions: Linked standards for identification of patients, products, places, and procedures, across supplies and hospital processes, constitute a wide-ranging information infrastructure with the potential for significant value to patients and the whole health system.
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Complexities and capabilities of Scan4Safety in NHS hospitals: a qualitative study of a national demonstrator site | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Complexities and capabilities of Scan4Safety in NHS hospitals: a qualitative study of a national demonstrator site Valentina Lichtner, Aleksandra Irnazarow, Stephen Bush, Dawn Dowding, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6057343/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Data standards and barcoding technologies are implemented in hospitals to uniquely identify objects, people and locations, streamline the management of supplies and inventories, improve efficiency, reduce waste and improve patient safety and quality of care. The UK Department of Health & Social Care Scan4Safety demonstrator programme (2016-2019) had six hospitals adopt global data standards to address these aims. This study examined the implementation of Scan4Safety at one NHS demonstrator site to understand the hospital experience of adopting these standards, barcoding and related technologies. Methods: Exploratory case study design, informed by information infrastructure theory, at one Scan4Safety demonstrator site. Semi-structured interviews were conducted with internal and external stakeholders, analysed thematically together with thematic analysis of documents related to the Scan4Safety programme. Results: The NHS Trust Scan4Safety team was interviewed, together with senior roles in procurement, inventory, recalls management, nurses and surgeons (n=15), and senior roles in other demonstrator sites, NHS supplies, as well as GS1 - the organization responsible for the standards (n=4); 67 documents were analysed. Key enablers for Scan4Safety included: allocated funding, government role/regulation, executive buy-in/wide stakeholder involvement, patient focus, agile/adaptive approach and data linkage. Challenges were both internal and external, mainly pertaining to data quality, work-as-done, and trade-offs. Mechanisms of anticipated positive outcomes, and potential risks were also identified. Conclusions: Linked standards for identification of patients, products, places, and procedures, across supplies and hospital processes, constitute a wide-ranging information infrastructure with the potential for significant value to patients and the whole health system. Health Policy Hospital Medicine Management Electronic Data Processing Patient Identification Systems Equipment and Supplies Hospitals Healthcare Infrastructure Capacity Building Figures Figure 1 Figure 2 Highlights What is already known on this topic Data standards encoded in barcodes facilitate tracking and tracing items across health systems, facilitating surveillance and management of resources. Little is known about use of barcodes in hospital inventory management, bed management, or traceability of implants, especially outside the US context. The Scan4Safety programme quantified efficiency savings derived from implementing GS1 standards and barcoding in NHS hospitals in England. What this study adds This study identifies anticipated benefits, as well as trade-offs and new safety risks associated with the use of standards and barcodes for unique identification of patients, beds management and tracking and tracing medical devices. How this study might affect research, practice or policy Recommendations are provided to support scaling-up Scan4Safety implementations, within a hospital and across the NHS. Background Barcoding technologies in hospital and the use of data standards for the unique identification of objects, people and locations, such as standards provided by the GS1 organization, 1 contribute to patient safety and quality of care, streamline the management of supplies and inventories through automation, improve efficiency and reduce waste. 2 – 9 Key patient safety applications or ‘use cases’ of these technologies are medication administration (known as bar coded medication administration; BCMA), 10 traceability of medical devices (implants) for post-market surveillance, 11 12 closed loop chains for blood and transfusion 13 and tracking samples in pathology. 14 Centralised inventories and tracing items by unique identifiers are also strategies for resilience, as made manifest by supply-chain shortages of medical devices experienced worldwide at the start of the COVID-19 pandemic. 15 16 To support the implementation of GS1 standards and barcoding in NHS hospitals in England, in 2016–2019 the UK Department of Health & Social Care (DHSC) ran the Scan4Safety demonstrator programme. 17 The programme funded six NHS hospital trusts as demonstrator sites, which were required to adopt the GS1 standards for the identification of products (e.g. medical equipment), people (patients), and places (e.g. hospital buildings), recorded in conjunction with processes (e.g. clinical procedures). An audit at the end of the programme identified benefits and lessons learned across the sites. 2 It provided evidence for a business case for further roll-out across the NHS. In 2022 NHS Wales and NHS Scotland started their own scan for safety programmes. 18 19 In 2023, NHS Supply Chain launched the national Inventory Management and Point of Care Solutions deployment programme in England 20 to further support up to 20 trusts in implementing inventory systems. In addition NHS England relaunched its Scan4Safety website. 17 There was no independent evaluation of the DHSC demonstrator programme. Little is known about Scan4Safety in NHS hospitals beyond the demonstrator programme case studies and GS1 publications to enable future users of the technology to implement it effectively. 2 7 17 21 This paper reports the findings of a study to evaluate the experience of implementing Scan4Safety, incorporating GS1 standards, barcoding and related technologies in one demonstrator site to inform future implementations. Methods Setting The study was conducted in one of the six DHSC Scan4Safety demonstrator sites, a large tertiary acute NHS Trust in the north of England. The DHSC programme required implementation of GS1 standards and barcodes over three use cases – inventory management, traceability of implants and orders/payments to suppliers (Appendix 1) leaving hospitals the choice of how and what other use cases to implement. The site extended Scan4Safety to a wider range of use cases, to encompass other hospitals’ operations, including, for example, bed management, infection control, mortuary, estate and security, but excluding medications. Scan4Safety implementation continued after the end of the DHSC programme. This study included all Scan4Safety activities at the study site, starting with the DHSC programme and subsequent developments. Research design The study was exploratory, informed by interpretivist paradigm and theories of healthcare technology implementations as sociotechnical systems/information infrastructures. 22 We used a qualitative case study design 23 with ethnographic methods, taking the hospital as the case. Data were gathered through interviews with hospital staff, and document analysis. Data collection activities took place between October 2023 and May 2024. Interviews Semi structured interviews with staff were conducted, asking them to describe and reflect on their experience of implementing or using Scan4Safety systems, and any challenges and benefits they identified (Appendix 2). A pragmatic and reflexive approach was undertaken for data sampling, 24 aiming to interview representatives of the Scan4Safety team, staff responsible for inventory/supply, and clinicians users of the technology. Interviews started with the Scan4Safety team; who were asked to identify and suggest other participants. This led to interviews with additional stakeholders outside of the initial site, at another demonstrator site, GS1 UK, and NHS Supply Chain. Interviews took place online (via MS-Teams). All interviews, apart from one, were conducted by two researchers together [initials removed]. With consent, interviews were audio-recorded. Recordings were professionally transcribed, and transcripts checked for accuracy. Documents Documents and other media, including policy documents mentioned by interviewees, reports, videos, or websites related to Scan4Safety in general, and specifically about the study site, were obtained. Participants provided organisational Scan4Safety documents in confidence. Other documents were identified through browsing the Scan4Safety and GS1 websites, searching Google, social media posts, and through searching cited references. Ethics The study received ethical approval from NHS Research Ethics Committee [reference removed]. The NHS Trust granted research governance approval. Interviewees were informed and gave consent before participating in the study. Data analysis methods Interview transcripts and documents were given a unique identifier (IDn; DOCn); transcripts from interviews with external interviewees were denoted by a suffix of ‘x’ (e.g. ID1-x). Data analysis was inductive. Initial analysis was in parallel to data collection and informed subsequent interview questions. Preliminary findings were discussed with the project advisory group, and their feedback incorporated into the analysis. The site Medical Director Operations and Scan4Safety Programme Manager were members of the advisory group and checked the findings for congruence and trustworthiness. Understanding of Scan4Safety was mapped in logic models. Subsequent analysis involved repeated reading of interview transcripts, seeking answers to the research questions, and interpretation through theoretical lenses. Documents were analysed to clarify concepts and events reported in interviews, and to gain a better understanding of the context of implementation. A research assistant helped to extract definitions, benefits and challenges from documents. Two researchers [initials removed] with background in information systems in healthcare and other sectors, carried out the analysis independently – using qualitative data analysis software Nvivo, and MS Excel spreadsheets. Themes identified by each researcher were discussed until consensus was reached. Results Eighteen interviews were conducted with 19 participants (one interview with two participants) (Table 1 ). Interviews lasted ~ 50 minutes (mean). Interviews with surgeons took about 10 minutes. 67 documents were analysed, including Scan4Safety official guidance, GS1 publications, web posts and videos, policy documents, and reports from public inquiries. Table 1 Interviewees roles and backgrounds Internal to Case Site Number of participants Scan4Safety Team - Programme and project management, including cross-trusts collaboration and Live Bed State project 5 Procurement and inventory – Senior roles, including also for commercial, e-commerce, specialist supplies and recalls 4 New digital hospital team – assistant role 1 Data science 1 Surgeons 2 Nursing – management role 1 Registered nurse, previously working at case site 1 External to Case Site NHS Supply Chains – engagement management 1 Other demonstrator site – programme management 1 GS1 UK – engagement management 2 Enabling factors Scan4Safety was considered ‘a pioneering initiative to bring 21st century data standards to our everyday work in the NHS’ [DOC50] - ‘a change of culture’ [ID8] towards data-driven hospitals. Six key enablers for Scan4Safety were identified (Appendix 4). Allocated funding Scan4Safety at the case site was a trust-wide change programme organized in improvement projects, each with specific funding allocation. Its history (Appendix 3) is marked by resourcing efforts. Some within site improvement projects after the end of the DHSC programme did not progress mainly due to lack of funding. Participants explained that Scan4Safety could be implemented at relatively low cost by adapting existing systems and technical infrastructure already in place. However, for implementation at scale, and if new information systems must be purchased, available protected funding is indispensable. DHSC involvement, policy and regulations Suppliers’ adoption of GS1 standards, and barcoding of products, were prerequisites for the feasibility of Scan4Safety in NHS hospitals. When Scan4Safety began, the largest suppliers of medical devices were already adopting GS1 standards, in response to forthcoming EU and USA regulation. Participants explained some suppliers appeared to be reticent to make the necessary investment without first evidence of use of those standards in the NHS. The DHSC demonstrator programme and a contractual agreement between the NHS and GS1 provided reassurance to suppliers about hospitals forthcoming use of those standards, facilitated suppliers’ adoption, and hence also Scan4Safety implementation. Incremental iterative adaptive development The programme was developed incrementally, iteratively, through learning by doing. It grew through an adaptive, agile and pragmatic user-centred approach - delivering not always the ‘ideal’ but building on the possible, given technical and other constraints. Scan4Safety implementations required constant monitoring, reviewing, and maintenance. Clinical executive buy-in and wide stakeholder involvement Other key enabler of Scan4Safety was a combination of clinical executive buy-in and involving stakeholders. Senior clinicians were involved, able to understand the programme and its benefits, able to communicate those benefits, and help unpack foreseeable issues and challenges. Patient focus All interviewees mentioned that the motivation behind Scan4Safety was improving services for patients. The DHSC programme primarily aimed at delivering efficiency and financial benefits. However, the recognition that a key motivator for clinician adoption and changing services was patients, their wellbeing and experience of care, led to a change in the name of the official programme, from a technical one, to the now established ‘Scan4Safety’. This was believed to facilitate clinicians’ adoption. Despite Scan4Safety being patient-focused, there was limited involvement of patients in the programme, both at the case site and externally. Linking data Understanding the importance of combining data and information across hospital operations for the benefit of patients, which an interviewee called ‘ a way of thinking’ [ID1] was essential. The necessary time was invested at the start of the Scan4Safety programme to understand how the GS1 standards could be used and combined. Defining and linking data fields for identification of products, patients, places and processes (‘the four Ps’), and capturing the data, required untangling interconnected hospital processes – as intricate as a ‘spider web’ . …you have to recognise that, it becomes really, it becomes like a spider web, that’s the easiest way to describe it, each one of these four Ps is a spider web. [ID6x] Barriers and complexities of implementation and adoption Barriers and complexities in the implementation and adoption of Scan4Safety were identified (Table 2 , Appendix 4), related to both structures and processes across the Scan4Safety life cycle and partly interdependent - implementation challenges leading to challenges in adoption, for example. Specifically, in using barcodes for traceability of medical devices, complexities span across the internal and external hospital supply chains, from local and global manufacturers to use at the point of care. Table 2 Barriers and complexities of Scan4Safety in NHS hospitals Note: Items in this table are interdependent (relate across columns). For example, ‘suppliers bypassing standard hospital processes’ is associated with data challenges (‘devices being supplied without GS1 barcodes’) and contribute to challenges to tracking and tracing processes (‘exceptions to workflows’). # Most of our data for the challenge of standardisation relates to standardisation across NHS trusts, rather than standardisation within a single trust or within the study site. Challenges external to the hospital organisation Internal to the hospital organization Challenges related to structures Challenges related to tracking and tracing processes Challenges related to trade-offs (choices) IT vendors not understanding the NHS (business models not fit for the NHS) *** Suppliers of devices not understanding barcodes and GS1 standards *** Suppliers of medical devices delivering directly to clinical areas bypassing standard hospital procurement processes Data: Patient identifier – NHS number not used consistently across NHS hospitals. Product identifiers changing over time. Location data changing without notice. *** Data fields for products that do not fit established categories or have variable states. *** Size and material properties of products/devices not fit for barcodes. *** Products supplied do not have associated data and barcodes (not set-up for scanning). *** Buildings and IT: Not sufficient devices, quality of the Wi-fi, data space, software limitations *** Not sufficient staff, not enough time (being short-staffed). Exceptions to workflows – having to re-design workflows/systems to cater for exceptions. *** Porous supply chain and products hidden in hospital wards. *** Uncertainties on which exact medical device will be used during surgery – having to re-design workflows to cater for uncertainties. *** Barcode scanning not consistent (not done for all devices and all patients) and not as designers’ intended (e.g. not at the right step in the workflow) – how to foster consistent and correct scanning (compliance), ongoing/repeated users’ training. *** How to mitigate new risks introduced by the roll-out of barcodes scanning for patients and medical devices. *** How to establish and maintain confidence that data is up to date (how to assess data quality). Should more/less work be done in tracking or in tracing (items/medical devices)? Not scanning barcodes (not tracking) items at the point of supply and use makes tracing items (in case of recalls) difficult and time consuming. Tracing items (in case of recalls) is easier and faster if more time is spent scanning barcodes (tracking) of items at each point of supply and use. Where/for which devices should Scan4Safety be implemented? How to prioritise? *** Standardisation versus customisation # What exceptions in workflows to cater for? What workflows should be standardised for best practice? What is best practice? Who decides and on what basis? Data-related complexities Maintaining data quality and establishing confidence in the quality of the data appeared to be a challenge. For example, when GS1 unique identifiers for products changed unexpectedly, or hospital locations changed without informing the Scan4Safety team for a change of identifiers. Most of the devices used for patient care, such as syringes or oxygen tubing, were not supplied to hospitals with GS1 identifiers and barcodes, and thus could not be easily tracked. Data challenges were also related to non-standard products and workflows. Data challenges were addressed in part through attention to work-as-done and redesign of technologies and data processes. For example, historical data were added to the system, in case suppliers changed identifiers for products; to cater for non-standard items (not already in hospital inventory system) the act of scanning was redesigned, from reading inventory data, to adding to the inventory. Prioritising and dealing with trade-offs Part of the challenge was dealing with trade offs. In particular time spent (saved by not) tracking items had to be balanced with time saved (spent) tracing recalled items. There was a perceived cost of staff time taken to scan items. As a consequence, despite Scan4Safety at the study site potentially including ‘ all the moving parts’ [ID2] (all items), in practice, priority had been given to tracking valuable items only – i.e. expensive, irreplaceable, associated to safety concerns. …5% of the products we buy into the Trust that we scan, there’s 95% […] we don’t scan [ID12]. Inconsistent and incorrect use of barcoding technologies The most difficult challenge to address was the lack of consistent clinical engagement – clinicians not scanning barcodes at the point of care or not following appropriate processes when scanning them (e.g. scanning after use, instead of before use, thus potentially missing safety alerts). Furthermore, there was a risk of users ‘reverting back’ to old ways of doing their work. This was addressed by repeating user training. …after a few months it goes back to how it was, there’s a bit of … complacency comes back in again. [ID15] Mechanisms and outcomes of Scan4Safety The activity of scanning barcodes produces data about items, patients, the time and place they were scanned at, by whom, for what task or procedure. The act of scanning may also generate an alert. The data recorded at the time of scanning may later be used in other activities. Data and alerts are outputs of Scan4Safety activities, that are distinguished from benefits that may derive from those outputs. They are produced by a set of mechanisms: linked standardised data/unique identifiers about people, places and products, automated alerts, automated data capture (removing manual data entry and transcription errors), the ability to electronically search (trace). The act of scanning is the lynchpin for these capabilities to be in place (Fig. 1 presents a simplified model, extended version in Appendix 5). A wide range of direct positive outputs and patient benefits across the varied use-cases of Scan4Safety were identified, as well as potential negative outcomes. Potential new risks to patient safety Two patient safety risks associated with incorrect or inconsistent use of barcoding for patient identification and traceability of implants were identified: 1) patients potentially receiving wrong treatments if their identifying barcode on their wristband is assumed to be correct, when it’s not; 2) data captured through barcodes about the use of implants (usually, but not always, consistently scanned) may be assumed to be complete and accurate when they are not, potentially leading to patients with unsafe recalled implants not being called for review. Wide-ranging anticipated benefits There are immediate, medium and longer-term benefits of Scan4Safety (Fig. 2 ). The immediate benefits are mostly related to individual patient care, while longer-term benefits mostly involve groups of patients, or the health system. Examples of health system benefits identified were shared inventories for better management of shortages and supplies across organizations, value-based procurement, better post-market surveillance of devices, and improved interoperability. Beyond its outcomes, the process of implementing Scan4Safety was also beneficial in itself - it provided opportunities for learning, reflection and ‘wheedl[ing] out some really bad practice’ [ID4]. Discussion Depending on how they are put to use, on what use cases, and how consistent is its use, the unique identification of people (patients), products and places, captured through barcodes, may deliver a wide range of benefits, through: tracking and tracing capabilities, automating data capture, alerts and electronic data linkages. There are a wide range of benefits that may derive from Scan4Safety technologies and GS1 data standards adoption including immediate and longer term benefits. However there are also safety risks related to barcoding for patient identification and traceability of implants. These risks may occur rarely, but it is important that implementers are aware of them and actions taken to mitigate them. The majority of items in hospital supplies are not tracked – meaning there is scope to expand the Scan4Safety programme to make management of shortages and recalls more effective and efficient. Necessary conditions for implementing Scan4Safety include adequate funding, and data infrastructure across a range of systems. Maintaining this infrastructure was found to be a challenge, including dealing with changes in suppliers’ data provision, and having clinicians capturing data consistently through barcodes at the point of care. Some of these challenges appear to be related to what could be called ‘data-in-practice’ being different from ‘data-as-imagined’, as well as work-as-done being different from work-as-imagined. 25 This study adds nuance to the available evidence about Scan4Safety in NHS hospitals 2 7 17 21 , highlighting not only benefits but also trade-offs and new safety risks. It enriches the understanding of the safety and efficiency improvements brought by Scan4Safety in the NHS. The enabling factors found in this study mirror those reported by an evaluation of another demonstrator programme for whole scale transformational change and modernization of healthcare services in London more than a decade ago 24 - ‘funding, vision, ethos, and collective effort’, as well as ‘imaginative and sustained efforts to ensure the long-term sustainability of the various gains’’. 24 Scan4Safety too is conceived as a transformational programme. Compared to previous modernisation programmes, Scan4Safety has data-specific enablers and challenges, also dependent on external stakeholders (manufacturers/suppliers of medical devices). These data challenges were also reported in studies of the implementation of unique identifiers of medical devices (UDI) in health services in the US. 26 These studies identified similar internal and external enablers and challenges; 26 27 among key enablers were implementers appreciation of the infrastructural nature of those data, and the key role of public policy mandates and support; among the challenges was stakeholders’ lack of UDI knowledge. They recommended strategies revolving around education, communication and policy. 27 The tracking/tracing trade-off involves a redistribution of work between roles, often found in systems implementations that shift administrative (back office) work to clinicians at the point of care. 28 However, in this site, clinicians were also responsible for back office work (e.g. management of recalls/tracing) and the ‘administrative’ act of scanning (tracking) was also capable of generating safety alerts, thus being a constituent part of clinical work, making the issue of redistribution of work between admin/clinical roles more subtle. Key recommendations for practice and policy to improve and scale up implementation and adoption of Scan4Safety are in Table 3 , and questions for further research in Appendix 6. The logic model derived from this study provides a framework for the design of evaluations of further Scan4Safety projects. Table 3 Key recommendations for practice and policy To facilitate implementation of Scan4Safety #1 Patients and the public should be involved in the design and implementation of Scan4Safety. #2 To enable broader implementation of Scan4Safety at scale in the NHS, ensure adequate funding that is protected for purpose. To facilitate adoption #3 Extend the capability for tracking and tracing afforded by Scan4Safety to a wider set of items, especially those that may be of low value but are essential for delivery of patient care. #4 Scan4Safety implementers must be responsive to operational work-as-done, rather than only the work-as-imagined, and pay attention to data standards-in-practice rather than only data standards-as-imagined #5 Scan4Safety systems must be maintained on an ongoing basis: keeping data up-to-date, auditing for missing data. Resources must be devoted to this maintenance work. #6 Scan4Safety training should include education about overall operational processes and data flows. Scan4Safety requires digital literacy among clinicians - it requires clinicians’ awareness of hospital operational processes beyond those for which they are responsible. Strengths and limitations A strength of this study is its wide scope over the entire Scan4Safety hospital infrastructure and the modelling of mechanisms and outcomes in a preliminary logic model. All members of the Scan4Safety teams as well as senior stakeholders were interviewed, but with limited input from clinicians/users of scanning technologies. The study did not examine the use of GS1 standards and barcoding for medications, as this was not a Scan4Safety use case implemented at the site. There may be specific mechanisms, benefits and issues in scanning medications missing from this study. However, the interview data was supplemented with a large number and variety of documentary materials, that also included clinicians’ views and medications. Some of the challenges identified may be specific to specific use cases. Conclusions By uniquely identifying patients, products, places, and procedures, through data standards, Scan4Safety builds an information infrastructure across hospitals’ internal and external supply chains, with the potential to deliver significant value to patients, clinicians, and the NHS. Declarations Competing interests SB is Non-Executive Director of GS1 UK, a member of the GS1 UK Healthcare Advisory Board and a member of the GS1 Global Healthcare Leadership team; MS is a member of the GS1 Healthcare User Group and GS1 Global Mission Specific Working Group Chairs for Demographics and Pathology. YHJ is theme co-lead and EDI lead of the National Institute for Health and Care Research (NIHR) Central London Patient Safety Research Collaboration (PSRC). 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Med Devices: Evid Res 2022:177–186 Vikkelsø S (2005) Subtle Redistribution of Work, Attention and Risks: Electronic Patient Records and Organisational Consequences. Scandinavian J Inform Syst ;17(1) Additional Declarations The authors declare potential competing interests as follows: SB is Non-Executive Director of GS1 UK, a member of the GS1 UK Healthcare Advisory Board and a member of the GS1 Global Healthcare Leadership team; MS is a member of the GS1 Healthcare User Group and GS1 Global Mission Specific Working Group Chairs for Demographics and Pathology. YHJ is theme co-lead and EDI lead of the National Institute for Health and Care Research (NIHR) Central London Patient Safety Research Collaboration (PSRC). All other authors have no competing interests to declare. The study was not externally funded. Funding for this study was provided by the University of Leeds Business School as part of research allowance. The University of Leeds sponsored this study. BDF is supported by the National Institute for Health and Care Research (NIHR) North West London Patient Safety Research Collaboration (PSRC). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Supplementary Files Appendix1Scan4SafetypillarsusecasesDFD.pdf Appendix 1_Box 1 –Scan4Safety pillars, use cases and linked systems Appendix2InterviewGuide.pdf Appendix 2- Interview guide Appendix3Timeline.pdf Appendix 3 – Timeline of Scan4Safety at study site Appendix4ThemesDataExamples.pdf Appendix 4 – Themes with data examples Appendix5LogicModels.pdf Appendix 5 - Logic models Appendix6QuestionsforResearch.pdf Appendix 6 - Questions for further research Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6057343","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":417564945,"identity":"06266319-8d0f-48d5-be8f-a2688686f8d8","order_by":0,"name":"Valentina Lichtner","email":"data:image/png;base64,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","orcid":"https://orcid.org/0000-0003-3956-3743","institution":"University of Manchester","correspondingAuthor":true,"prefix":"","firstName":"Valentina","middleName":"","lastName":"Lichtner","suffix":""},{"id":417564946,"identity":"b1f5f2a8-57ff-46b0-af6e-8fea4c24fd51","order_by":1,"name":"Aleksandra Irnazarow","email":"","orcid":"","institution":"University of Leeds","correspondingAuthor":false,"prefix":"","firstName":"Aleksandra","middleName":"","lastName":"Irnazarow","suffix":""},{"id":417565179,"identity":"71cd0548-d3d9-4d88-a30a-e5037315cfd2","order_by":2,"name":"Stephen Bush","email":"","orcid":"","institution":"Leeds Teaching Hospitals NHS Trust","correspondingAuthor":false,"prefix":"","firstName":"Stephen","middleName":"","lastName":"Bush","suffix":""},{"id":417566827,"identity":"a4f64028-a976-4423-bc61-003019483e52","order_by":3,"name":"Dawn Dowding","email":"","orcid":"","institution":"University of Manchester","correspondingAuthor":false,"prefix":"","firstName":"Dawn","middleName":"","lastName":"Dowding","suffix":""},{"id":417566828,"identity":"2e6609fd-e00d-4510-acbf-5bdb46b1328f","order_by":4,"name":"Philip Elphick","email":"","orcid":"","institution":"Leeds Teaching Hospitals NHS Trust","correspondingAuthor":false,"prefix":"","firstName":"Philip","middleName":"","lastName":"Elphick","suffix":""},{"id":417566829,"identity":"8a9fdecb-fe64-4a4f-9215-d9cd0b6d1244","order_by":5,"name":"Bryony Dean Franklin","email":"","orcid":"","institution":"School of Pharmacy, University College London, and NIHR North West London Patient Safety Research Collaboration, London, UK","correspondingAuthor":false,"prefix":"","firstName":"Bryony","middleName":"Dean","lastName":"Franklin","suffix":""},{"id":417566830,"identity":"a0bdc842-6d36-4053-97a2-b767f3cb141e","order_by":6,"name":"Yogini H Jani","email":"","orcid":"","institution":"School of Pharmacy, University College London and Centre for Medicines Optimisation Research and Education, University College London Hospitals NHS Foundation Trust, London, UK","correspondingAuthor":false,"prefix":"","firstName":"Yogini","middleName":"H","lastName":"Jani","suffix":""},{"id":417566831,"identity":"7678bc23-badb-4f48-af94-a2c9b256b6d5","order_by":7,"name":"Mark Songhurst","email":"","orcid":"","institution":"Leeds Teaching Hospitals NHS Trust, Leeds, UK","correspondingAuthor":false,"prefix":"","firstName":"Mark","middleName":"","lastName":"Songhurst","suffix":""}],"badges":[],"createdAt":"2025-02-18 14:59:28","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":true,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-6057343/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6057343/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":77356897,"identity":"97b53a28-b951-4ceb-90d2-7b49f051874b","added_by":"auto","created_at":"2025-02-27 18:08:37","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1630208,"visible":true,"origin":"","legend":"\u003cp\u003eSimplified logic model of Scan4Safety for key use cases: inventory and medical devices – mechanisms and outcomes of scanning (top) and not-scanning (bottom) GS1 barcodes\u003c/p\u003e","description":"","filename":"Figure1logicmodelmd.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6057343/v1/ec04e33294c0d633acfe7421.jpg"},{"id":77355950,"identity":"4e22f585-cabb-45b1-b830-28d083a88bf7","added_by":"auto","created_at":"2025-02-27 18:00:38","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":2403883,"visible":true,"origin":"","legend":"\u003cp\u003eDirect outputs and benefits of Scan4Safety\u003c/p\u003e","description":"","filename":"Figure2Benefitsxs.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6057343/v1/c0a2c1ab3ff4d65e7e85a101.jpg"},{"id":77361837,"identity":"6116fd21-673c-436c-b2ad-5d49a01858ce","added_by":"auto","created_at":"2025-02-27 20:02:43","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":4850949,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6057343/v1/26da9d5b-ee27-4ecf-b05f-6ba9b48630fc.pdf"},{"id":77355935,"identity":"71c50a38-bf81-46f0-8f86-dd2a7efc28e7","added_by":"auto","created_at":"2025-02-27 18:00:37","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":295657,"visible":true,"origin":"","legend":"\u003cp\u003eAppendix 1_Box 1 –Scan4Safety pillars, use cases and linked systems\u003c/p\u003e","description":"","filename":"Appendix1Scan4SafetypillarsusecasesDFD.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6057343/v1/a80558907ded76a9d05edac2.pdf"},{"id":77357206,"identity":"65fc7bb4-d44e-46b1-b537-686dd806b3d0","added_by":"auto","created_at":"2025-02-27 18:16:37","extension":"pdf","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":148056,"visible":true,"origin":"","legend":"\u003cp\u003eAppendix 2- Interview guide\u003c/p\u003e","description":"","filename":"Appendix2InterviewGuide.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6057343/v1/fe52c56f088e8b806994e7b4.pdf"},{"id":77355936,"identity":"b32f8e6b-d33a-4bc8-9cb9-1a51c0dab140","added_by":"auto","created_at":"2025-02-27 18:00:37","extension":"pdf","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":101105,"visible":true,"origin":"","legend":"\u003cp\u003eAppendix 3 – Timeline of Scan4Safety at study site\u003c/p\u003e","description":"","filename":"Appendix3Timeline.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6057343/v1/ecbc51efe9662ee765627176.pdf"},{"id":77356901,"identity":"242c8aaf-4214-49c7-9c1d-56161177d9a4","added_by":"auto","created_at":"2025-02-27 18:08:37","extension":"pdf","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":193357,"visible":true,"origin":"","legend":"\u003cp\u003eAppendix 4 – Themes with data examples\u003c/p\u003e","description":"","filename":"Appendix4ThemesDataExamples.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6057343/v1/9517486c01e1b3fdc20f998b.pdf"},{"id":77355944,"identity":"8765499f-a143-4486-bb03-95423cc16c25","added_by":"auto","created_at":"2025-02-27 18:00:37","extension":"pdf","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":247086,"visible":true,"origin":"","legend":"\u003cp\u003eAppendix 5 - Logic models\u003c/p\u003e","description":"","filename":"Appendix5LogicModels.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6057343/v1/dff5b3352f599cf8ff2dc9d5.pdf"},{"id":77355953,"identity":"681c04d5-51e3-4b59-a0fb-a708787160c5","added_by":"auto","created_at":"2025-02-27 18:00:38","extension":"pdf","order_by":6,"title":"","display":"","copyAsset":false,"role":"supplement","size":157758,"visible":true,"origin":"","legend":"\u003cp\u003eAppendix 6 - Questions for further research\u003c/p\u003e","description":"","filename":"Appendix6QuestionsforResearch.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6057343/v1/548680927a4d10b753175f05.pdf"}],"financialInterests":"The authors declare potential competing interests as follows: SB is Non-Executive Director of GS1 UK, a member of the GS1 UK Healthcare Advisory Board and a member of the GS1 Global Healthcare Leadership team; MS is a member of the GS1 Healthcare User Group and GS1 Global Mission Specific Working Group Chairs for Demographics and Pathology. YHJ is theme co-lead and EDI lead of the National Institute for Health and Care Research (NIHR) Central London Patient Safety Research Collaboration (PSRC). All other authors have no competing interests to declare.\nThe study was not externally funded. Funding for this study was provided by the University of Leeds Business School as part of research allowance. The University of Leeds sponsored this study. BDF is supported by the National Institute for Health and Care Research (NIHR) North West London Patient Safety Research Collaboration (PSRC). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eComplexities and capabilities of Scan4Safety in NHS hospitals: a qualitative study of a national demonstrator site\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Highlights","content":"\u003cp\u003eWhat is already known on this topic\u003c/p\u003e\u003cp\u003eData standards encoded in barcodes facilitate tracking and tracing items across health systems, facilitating surveillance and management of resources.\u003c/p\u003e\u003cp\u003eLittle is known about use of barcodes in hospital inventory management, bed management, or traceability of implants, especially outside the US context.\u003c/p\u003e\u003cp\u003eThe Scan4Safety programme quantified efficiency savings derived from implementing GS1 standards and barcoding in NHS hospitals in England.\u003c/p\u003e\u003cp\u003eWhat this study adds\u003c/p\u003e\u003cp\u003eThis study identifies anticipated benefits, as well as trade-offs and new safety risks associated with the use of standards and barcodes for unique identification of patients, beds management and tracking and tracing medical devices.\u003c/p\u003e\u003cp\u003eHow this study might affect research, practice or policy\u003c/p\u003e\u003cp\u003eRecommendations are provided to support scaling-up Scan4Safety implementations, within a hospital and across the NHS.\u003c/p\u003e"},{"header":"Background","content":"\u003cp\u003eBarcoding technologies in hospital and the use of data standards for the unique identification of objects, people and locations, such as standards provided by the GS1 organization,\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e contribute to patient safety and quality of care, streamline the management of supplies and inventories through automation, improve efficiency and reduce waste.\u003csup\u003e\u003cspan additionalcitationids=\"CR3 CR4 CR5 CR6 CR7 CR8\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e Key patient safety applications or \u0026lsquo;use cases\u0026rsquo; of these technologies are medication administration (known as bar coded medication administration; BCMA),\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e traceability of medical devices (implants) for post-market surveillance,\u003csup\u003e11 12\u003c/sup\u003e closed loop chains for blood and transfusion\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e and tracking samples in pathology.\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e Centralised inventories and tracing items by unique identifiers are also strategies for resilience, as made manifest by supply-chain shortages of medical devices experienced worldwide at the start of the COVID-19 pandemic.\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eTo support the implementation of GS1 standards and barcoding in NHS hospitals in England, in 2016\u0026ndash;2019 the UK Department of Health \u0026amp; Social Care (DHSC) ran the Scan4Safety demonstrator programme.\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e The programme funded six NHS hospital trusts as demonstrator sites, which were required to adopt the GS1 standards for the identification of products (e.g. medical equipment), people (patients), and places (e.g. hospital buildings), recorded in conjunction with processes (e.g. clinical procedures). An audit at the end of the programme identified benefits and lessons learned across the sites.\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e It provided evidence for a business case for further roll-out across the NHS. In 2022 NHS Wales and NHS Scotland started their own scan for safety programmes.\u003csup\u003e18 19\u003c/sup\u003e In 2023, NHS Supply Chain launched the national Inventory Management and Point of Care Solutions deployment programme in England\u003csup\u003e\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e to further support up to 20 trusts in implementing inventory systems. In addition NHS England relaunched its Scan4Safety website.\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThere was no independent evaluation of the DHSC demonstrator programme. Little is known about Scan4Safety in NHS hospitals beyond the demonstrator programme case studies and GS1 publications to enable future users of the technology to implement it effectively. \u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThis paper reports the findings of a study to evaluate the experience of implementing Scan4Safety, incorporating GS1 standards, barcoding and related technologies in one demonstrator site to inform future implementations.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eSetting\u003c/h2\u003e \u003cp\u003eThe study was conducted in one of the six DHSC Scan4Safety demonstrator sites, a large tertiary acute NHS Trust in the north of England. The DHSC programme required implementation of GS1 standards and barcodes over three use cases \u0026ndash; inventory management, traceability of implants and orders/payments to suppliers (Appendix 1) leaving hospitals the choice of how and what other use cases to implement. The site extended Scan4Safety to a wider range of use cases, to encompass other hospitals\u0026rsquo; operations, including, for example, bed management, infection control, mortuary, estate and security, but excluding medications. Scan4Safety implementation continued after the end of the DHSC programme. This study included all Scan4Safety activities at the study site, starting with the DHSC programme and subsequent developments.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eResearch design\u003c/h3\u003e\n\u003cp\u003eThe study was exploratory, informed by interpretivist paradigm and theories of healthcare technology implementations as sociotechnical systems/information infrastructures.\u003csup\u003e\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e We used a qualitative case study design\u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u003c/sup\u003e with ethnographic methods, taking the hospital as the case. Data were gathered through interviews with hospital staff, and document analysis. Data collection activities took place between October 2023 and May 2024.\u003c/p\u003e\n\u003ch3\u003eInterviews\u003c/h3\u003e\n\u003cp\u003eSemi structured interviews with staff were conducted, asking them to describe and reflect on their experience of implementing or using Scan4Safety systems, and any challenges and benefits they identified (Appendix 2). A pragmatic and reflexive approach was undertaken for data sampling,\u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e aiming to interview representatives of the Scan4Safety team, staff responsible for inventory/supply, and clinicians users of the technology. Interviews started with the Scan4Safety team; who were asked to identify and suggest other participants. This led to interviews with additional stakeholders outside of the initial site, at another demonstrator site, GS1 UK, and NHS Supply Chain.\u003c/p\u003e \u003cp\u003eInterviews took place online (via MS-Teams). All interviews, apart from one, were conducted by two researchers together [initials removed]. With consent, interviews were audio-recorded. Recordings were professionally transcribed, and transcripts checked for accuracy.\u003c/p\u003e\n\u003ch3\u003eDocuments\u003c/h3\u003e\n\u003cp\u003eDocuments and other media, including policy documents mentioned by interviewees, reports, videos, or websites related to Scan4Safety in general, and specifically about the study site, were obtained. Participants provided organisational Scan4Safety documents in confidence. Other documents were identified through browsing the Scan4Safety and GS1 websites, searching Google, social media posts, and through searching cited references.\u003c/p\u003e\n\u003ch3\u003eEthics\u003c/h3\u003e\n\u003cp\u003eThe study received ethical approval from NHS Research Ethics Committee [reference removed]. The NHS Trust granted research governance approval. Interviewees were informed and gave consent before participating in the study.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eData analysis methods\u003c/h2\u003e \u003cp\u003eInterview transcripts and documents were given a unique identifier (IDn; DOCn); transcripts from interviews with external interviewees were denoted by a suffix of \u0026lsquo;x\u0026rsquo; (e.g. ID1-x). Data analysis was inductive. Initial analysis was in parallel to data collection and informed subsequent interview questions. Preliminary findings were discussed with the project advisory group, and their feedback incorporated into the analysis. The site Medical Director Operations and Scan4Safety Programme Manager were members of the advisory group and checked the findings for congruence and trustworthiness. Understanding of Scan4Safety was mapped in logic models.\u003c/p\u003e \u003cp\u003eSubsequent analysis involved repeated reading of interview transcripts, seeking answers to the research questions, and interpretation through theoretical lenses. Documents were analysed to clarify concepts and events reported in interviews, and to gain a better understanding of the context of implementation. A research assistant helped to extract definitions, benefits and challenges from documents. Two researchers [initials removed] with background in information systems in healthcare and other sectors, carried out the analysis independently \u0026ndash; using qualitative data analysis software Nvivo, and MS Excel spreadsheets. Themes identified by each researcher were discussed until consensus was reached.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eEighteen interviews were conducted with 19 participants (one interview with two participants) (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Interviews lasted\u0026thinsp;~\u0026thinsp;50 minutes (mean). Interviews with surgeons took about 10 minutes. 67 documents were analysed, including Scan4Safety official guidance, GS1 publications, web posts and videos, policy documents, and reports from public inquiries.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eInterviewees roles and backgrounds\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInternal to Case Site\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNumber of participants\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eScan4Safety Team -\u003c/p\u003e \u003cp\u003eProgramme and project management, including cross-trusts collaboration and Live Bed State project\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProcurement and inventory \u0026ndash;\u003c/p\u003e \u003cp\u003eSenior roles, including also for commercial, e-commerce, specialist supplies and recalls\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNew digital hospital team \u0026ndash; assistant role\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eData science\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurgeons\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNursing \u0026ndash; management role\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRegistered nurse, previously working at case site\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eExternal to Case Site\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNHS Supply Chains \u0026ndash; engagement management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther demonstrator site \u0026ndash; programme management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGS1 UK \u0026ndash; engagement management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e\n\u003ch3\u003eEnabling factors\u003c/h3\u003e\n\u003cp\u003eScan4Safety was considered \u0026lsquo;a pioneering initiative to bring 21st century data standards to our everyday work in the NHS\u0026rsquo; [DOC50] - \u0026lsquo;a change of culture\u0026rsquo; [ID8] towards data-driven hospitals. Six key enablers for Scan4Safety were identified (Appendix 4).\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eAllocated funding\u003c/h2\u003e \u003cp\u003eScan4Safety at the case site was a trust-wide change programme organized in improvement projects, each with specific funding allocation. Its history (Appendix 3) is marked by resourcing efforts. Some within site improvement projects after the end of the DHSC programme did not progress mainly due to lack of funding. Participants explained that Scan4Safety could be implemented at relatively low cost by adapting existing systems and technical infrastructure already in place. However, for implementation at scale, and if new information systems must be purchased, available protected funding is indispensable.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eDHSC involvement, policy and regulations\u003c/h2\u003e \u003cp\u003eSuppliers\u0026rsquo; adoption of GS1 standards, and barcoding of products, were prerequisites for the feasibility of Scan4Safety in NHS hospitals. When Scan4Safety began, the largest suppliers of medical devices were already adopting GS1 standards, in response to forthcoming EU and USA regulation. Participants explained some suppliers appeared to be reticent to make the necessary investment without first evidence of use of those standards in the NHS. The DHSC demonstrator programme and a contractual agreement between the NHS and GS1 provided reassurance to suppliers about hospitals forthcoming use of those standards, facilitated suppliers\u0026rsquo; adoption, and hence also Scan4Safety implementation.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eIncremental iterative adaptive development\u003c/h2\u003e \u003cp\u003eThe programme was developed incrementally, iteratively, through learning by doing. It grew through an adaptive, agile and pragmatic user-centred approach - delivering not always the \u0026lsquo;ideal\u0026rsquo; but building on the possible, given technical and other constraints. Scan4Safety implementations required constant monitoring, reviewing, and maintenance.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eClinical executive buy-in and wide stakeholder involvement\u003c/h2\u003e \u003cp\u003eOther key enabler of Scan4Safety was a combination of clinical executive buy-in and involving stakeholders. Senior clinicians were involved, able to understand the programme and its benefits, able to communicate those benefits, and help unpack foreseeable issues and challenges.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003ePatient focus\u003c/h2\u003e \u003cp\u003eAll interviewees mentioned that the motivation behind Scan4Safety was improving services for patients. The DHSC programme primarily aimed at delivering efficiency and financial benefits. However, the recognition that a key motivator for clinician adoption and changing services was patients, their wellbeing and experience of care, led to a change in the name of the official programme, from a technical one, to the now established \u0026lsquo;Scan4Safety\u0026rsquo;. This was believed to facilitate clinicians\u0026rsquo; adoption.\u003c/p\u003e \u003cp\u003eDespite Scan4Safety being patient-focused, there was limited involvement of patients in the programme, both at the case site and externally.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eLinking data\u003c/h2\u003e \u003cp\u003eUnderstanding the importance of combining data and information across hospital operations for the benefit of patients, which an interviewee called \u0026lsquo;\u003cem\u003ea way of thinking\u0026rsquo;\u003c/em\u003e [ID1] was essential. The necessary time was invested at the start of the Scan4Safety programme to understand how the GS1 standards could be used and combined. Defining and linking data fields for identification of products, patients, places and processes (\u0026lsquo;the four Ps\u0026rsquo;), and capturing the data, required untangling interconnected hospital processes \u0026ndash; as intricate as a \u003cem\u003e\u0026lsquo;spider web\u0026rsquo;\u003c/em\u003e.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026hellip;you have to recognise that, it becomes really, it becomes like a spider web, that\u0026rsquo;s the easiest way to describe it, each one of these four Ps is a spider web. [ID6x]\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eBarriers and complexities of implementation and adoption\u003c/h2\u003e \u003cp\u003eBarriers and complexities in the implementation and adoption of Scan4Safety were identified (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, Appendix 4), related to both structures and processes across the Scan4Safety life cycle and partly interdependent - implementation challenges leading to challenges in adoption, for example. Specifically, in using barcodes for traceability of medical devices, complexities span across the internal and external hospital supply chains, from local and global manufacturers to use at the point of care.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBarriers and complexities of Scan4Safety in NHS hospitals Note: Items in this table are interdependent (relate across columns). For example, \u0026lsquo;suppliers bypassing standard hospital processes\u0026rsquo; is associated with data challenges (\u0026lsquo;devices being supplied without GS1 barcodes\u0026rsquo;) and contribute to challenges to tracking and tracing processes (\u0026lsquo;exceptions to workflows\u0026rsquo;). # Most of our data for the challenge of standardisation relates to standardisation across NHS trusts, rather than standardisation within a single trust or within the study site.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eChallenges external to the hospital organisation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c5\" namest=\"c3\"\u003e \u003cp\u003eInternal to the hospital organization\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eChallenges related to \u003cb\u003estructures\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eChallenges related to \u003cb\u003etracking and tracing processes\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eChallenges related to \u003cb\u003etrade-offs (choices)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIT vendors not understanding the NHS (business models not fit for the NHS)\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eSuppliers of devices not understanding barcodes and GS1 standards\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eSuppliers of medical devices delivering directly to clinical areas bypassing standard hospital procurement processes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eData:\u003c/p\u003e \u003cp\u003ePatient identifier \u0026ndash; NHS number not used consistently across NHS hospitals.\u003c/p\u003e \u003cp\u003eProduct identifiers changing over time.\u003c/p\u003e \u003cp\u003eLocation data changing without notice.\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eData fields for products that do not fit established categories or have variable states.\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eSize and material properties of products/devices not fit for barcodes.\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eProducts supplied do not have associated data and barcodes (not set-up for scanning).\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eBuildings and IT:\u003c/p\u003e \u003cp\u003eNot sufficient devices, quality of the Wi-fi, data space, software limitations\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eNot sufficient staff, not enough time (being short-staffed).\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eExceptions to workflows \u0026ndash; having to re-design workflows/systems to cater for exceptions.\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003ePorous supply chain and products hidden in hospital wards.\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eUncertainties on which exact medical device will be used during surgery \u0026ndash; having to re-design workflows to cater for uncertainties.\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eBarcode scanning not consistent (not done for all devices and all patients) and not as designers\u0026rsquo; intended (e.g. not at the right step in the workflow) \u0026ndash; how to foster consistent and correct scanning (compliance), ongoing/repeated users\u0026rsquo; training.\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eHow to mitigate new risks introduced by the roll-out of barcodes scanning for patients and medical devices.\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eHow to establish and maintain confidence that data is up to date (how to assess data quality).\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eShould more/less work be done in tracking or in tracing (items/medical devices)?\u003c/p\u003e \u003cp\u003eNot scanning barcodes (not tracking) items at the point of supply and use makes tracing items (in case of recalls) difficult and time consuming.\u003c/p\u003e \u003cp\u003eTracing items (in case of recalls) is easier and faster if more time is spent scanning barcodes (tracking) of items at each point of supply and use.\u003c/p\u003e \u003cp\u003eWhere/for which devices should Scan4Safety be implemented? How to prioritise?\u003c/p\u003e \u003cp\u003e***\u003c/p\u003e \u003cp\u003eStandardisation versus customisation \u003csup\u003e#\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eWhat exceptions in workflows to cater for?\u003c/p\u003e \u003cp\u003eWhat workflows should be standardised for best practice?\u003c/p\u003e \u003cp\u003eWhat is best practice? Who decides and on what basis?\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eData-related complexities\u003c/h2\u003e \u003cp\u003eMaintaining data quality and establishing confidence in the quality of the data appeared to be a challenge. For example, when GS1 unique identifiers for products changed unexpectedly, or hospital locations changed without informing the Scan4Safety team for a change of identifiers. Most of the devices used for patient care, such as syringes or oxygen tubing, were not supplied to hospitals with GS1 identifiers and barcodes, and thus could not be easily tracked. Data challenges were also related to non-standard products and workflows.\u003c/p\u003e \u003cp\u003eData challenges were addressed in part through attention to work-as-done and redesign of technologies and data processes. For example, historical data were added to the system, in case suppliers changed identifiers for products; to cater for non-standard items (not already in hospital inventory system) the act of scanning was redesigned, from reading inventory data, to adding to the inventory.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003ePrioritising and dealing with trade-offs\u003c/h2\u003e \u003cp\u003ePart of the challenge was dealing with trade offs. In particular time spent (saved by not) tracking items had to be balanced with time saved (spent) tracing recalled items.\u003c/p\u003e \u003cp\u003eThere was a perceived cost of staff time taken to scan items. As a consequence, despite Scan4Safety at the study site potentially including \u0026lsquo;\u003cem\u003eall the moving parts\u0026rsquo;\u003c/em\u003e [ID2] (all items), in practice, priority had been given to tracking valuable items only \u0026ndash; i.e. expensive, irreplaceable, associated to safety concerns.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026hellip;5% of the products we buy into the Trust that we scan, there\u0026rsquo;s 95% [\u0026hellip;] we don\u0026rsquo;t scan [ID12].\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eInconsistent and incorrect use of barcoding technologies\u003c/h2\u003e \u003cp\u003eThe most difficult challenge to address was the lack of consistent clinical engagement \u0026ndash; clinicians not scanning barcodes at the point of care or not following appropriate processes when scanning them (e.g. scanning after use, instead of before use, thus potentially missing safety alerts). Furthermore, there was a risk of users \u0026lsquo;reverting back\u0026rsquo; to old ways of doing their work. This was addressed by repeating user training.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026hellip;after a few months it goes back to how it was, there\u0026rsquo;s a bit of \u0026hellip; complacency comes back in again. [ID15]\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eMechanisms and outcomes of Scan4Safety\u003c/h2\u003e \u003cp\u003eThe activity of scanning barcodes produces data about items, patients, the time and place they were scanned at, by whom, for what task or procedure. The act of scanning may also generate an alert. The data recorded at the time of scanning may later be used in other activities. Data and alerts are \u003cem\u003eoutputs\u003c/em\u003e of Scan4Safety activities, that are distinguished from \u003cem\u003ebenefits\u003c/em\u003e that may derive from those outputs. They are produced by a set of mechanisms: linked standardised data/unique identifiers about people, places and products, automated alerts, automated data capture (removing manual data entry and transcription errors), the ability to electronically search (trace). The act of scanning is the lynchpin for these capabilities to be in place (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e presents a simplified model, extended version in Appendix 5). A wide range of direct positive outputs and patient benefits across the varied use-cases of Scan4Safety were identified, as well as potential negative outcomes.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003ePotential new risks to patient safety\u003c/h2\u003e \u003cp\u003eTwo patient safety risks associated with incorrect or inconsistent use of barcoding for patient identification and traceability of implants were identified: 1) patients potentially receiving wrong treatments if their identifying barcode on their wristband is assumed to be correct, when it\u0026rsquo;s not; 2) data captured through barcodes about the use of implants (usually, but not always, consistently scanned) may be assumed to be complete and accurate when they are not, potentially leading to patients with unsafe recalled implants not being called for review.\u003c/p\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003eWide-ranging anticipated benefits\u003c/h2\u003e \u003cp\u003eThere are immediate, medium and longer-term benefits of Scan4Safety (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The immediate benefits are mostly related to individual patient care, while longer-term benefits mostly involve groups of patients, or the health system. Examples of health system benefits identified were shared inventories for better management of shortages and supplies across organizations, value-based procurement, better post-market surveillance of devices, and improved interoperability.\u003c/p\u003e \u003cp\u003eBeyond its outcomes, the process of implementing Scan4Safety was also beneficial in itself - it provided opportunities for learning, reflection and \u003cem\u003e\u0026lsquo;wheedl[ing] out some really bad practice\u0026rsquo;\u003c/em\u003e [ID4].\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eDepending on how they are put to use, on what use cases, and how consistent is its use, the unique identification of people (patients), products and places, captured through barcodes, may deliver a wide range of benefits, through: tracking and tracing capabilities, automating data capture, alerts and electronic data linkages. There are a wide range of benefits that may derive from Scan4Safety technologies and GS1 data standards adoption including immediate and longer term benefits. However there are also safety risks related to barcoding for patient identification and traceability of implants. These risks may occur rarely, but it is important that implementers are aware of them and actions taken to mitigate them. The majority of items in hospital supplies are not tracked \u0026ndash; meaning there is scope to expand the Scan4Safety programme to make management of shortages and recalls more effective and efficient.\u003c/p\u003e \u003cp\u003eNecessary conditions for implementing Scan4Safety include adequate funding, and data infrastructure across a range of systems. Maintaining this infrastructure was found to be a challenge, including dealing with changes in suppliers\u0026rsquo; data provision, and having clinicians capturing data consistently through barcodes at the point of care. Some of these challenges appear to be related to what could be called \u0026lsquo;data-in-practice\u0026rsquo; being different from \u0026lsquo;data-as-imagined\u0026rsquo;, as well as work-as-done being different from work-as-imagined.\u003csup\u003e\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThis study adds nuance to the available evidence about Scan4Safety in NHS hospitals \u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e, highlighting not only benefits but also trade-offs and new safety risks. It enriches the understanding of the safety and efficiency improvements brought by Scan4Safety in the NHS.\u003c/p\u003e \u003cp\u003eThe enabling factors found in this study mirror those reported by an evaluation of another demonstrator programme for whole scale transformational change and modernization of healthcare services in London more than a decade ago \u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e - \u0026lsquo;funding, vision, ethos, and collective effort\u0026rsquo;, as well as \u0026lsquo;imaginative and sustained efforts to ensure the long-term sustainability of the various gains\u0026rsquo;\u0026rsquo;.\u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e Scan4Safety too is conceived as a transformational programme. Compared to previous modernisation programmes, Scan4Safety has data-specific enablers and challenges, also dependent on external stakeholders (manufacturers/suppliers of medical devices). These data challenges were also reported in studies of the implementation of unique identifiers of medical devices (UDI) in health services in the US.\u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e These studies identified similar internal and external enablers and challenges;\u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e among key enablers were implementers appreciation of the infrastructural nature of those data, and the key role of public policy mandates and support; among the challenges was stakeholders\u0026rsquo; lack of UDI knowledge. They recommended strategies revolving around education, communication and policy.\u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe tracking/tracing trade-off involves a redistribution of work between roles, often found in systems implementations that shift administrative (back office) work to clinicians at the point of care.\u003csup\u003e\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e However, in this site, clinicians were also responsible for back office work (e.g. management of recalls/tracing) and the \u0026lsquo;administrative\u0026rsquo; act of scanning (tracking) was also capable of generating safety alerts, thus being a constituent part of clinical work, making the issue of redistribution of work between admin/clinical roles more subtle.\u003c/p\u003e \u003cp\u003eKey recommendations for practice and policy to improve and scale up implementation and adoption of Scan4Safety are in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e, and questions for further research in Appendix 6. The logic model derived from this study provides a framework for the design of evaluations of further Scan4Safety projects.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eKey recommendations for practice and policy\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTo facilitate implementation of Scan4Safety\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e#1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePatients and the public should be involved in the design and implementation of Scan4Safety.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e#2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTo enable broader implementation of Scan4Safety at scale in the NHS, ensure adequate funding that is protected for purpose.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eTo facilitate adoption\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e#3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eExtend the capability for tracking and tracing afforded by Scan4Safety to a wider set of items, especially those that may be of low value but are essential for delivery of patient care.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e#4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eScan4Safety implementers must be responsive to operational work-as-done, rather than only the work-as-imagined, and pay attention to data standards-in-practice rather than only data standards-as-imagined\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e#5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eScan4Safety systems must be maintained on an ongoing basis: keeping data up-to-date, auditing for missing data. Resources must be devoted to this maintenance work.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e#6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eScan4Safety training should include education about overall operational processes and data flows. Scan4Safety requires digital literacy among clinicians - it requires clinicians\u0026rsquo; awareness of hospital operational processes beyond those for which they are responsible.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec25\" class=\"Section2\"\u003e \u003ch2\u003eStrengths and limitations\u003c/h2\u003e \u003cp\u003eA strength of this study is its wide scope over the entire Scan4Safety hospital infrastructure and the modelling of mechanisms and outcomes in a preliminary logic model. All members of the Scan4Safety teams as well as senior stakeholders were interviewed, but with limited input from clinicians/users of scanning technologies. The study did not examine the use of GS1 standards and barcoding for medications, as this was not a Scan4Safety use case implemented at the site. There may be specific mechanisms, benefits and issues in scanning medications missing from this study. However, the interview data was supplemented with a large number and variety of documentary materials, that also included clinicians\u0026rsquo; views and medications. Some of the challenges identified may be specific to specific use cases.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusions","content":"\u003cp\u003eBy uniquely identifying patients, products, places, and procedures, through data standards, Scan4Safety builds an information infrastructure across hospitals\u0026rsquo; internal and external supply chains, with the potential to deliver significant value to patients, clinicians, and the NHS.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003ch2\u003eCompeting interests\u003c/h2\u003e \u003cp\u003e SB is Non-Executive Director of GS1 UK, a member of the GS1 UK Healthcare Advisory Board and a member of the GS1 Global Healthcare Leadership team; MS is a member of the GS1 Healthcare User Group and GS1 Global Mission Specific Working Group Chairs for Demographics and Pathology. YHJ is theme co-lead and EDI lead of the National Institute for Health and Care Research (NIHR) Central London Patient Safety Research Collaboration (PSRC). All other authors have no competing interests to declare.\u003c/p\u003e \u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eGS1 UK. GS1 UK - The Global Language of Healthcare: GS1 UK (2024) [Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://healthcare.gs1uk.org/\u003c/span\u003e\u003cspan address=\"https://healthcare.gs1uk.org/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGS1 UK (2020) Improving patient safety and saving money using point-of-care scanning in the NHS. 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[Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://humanisticsystems.com/2020/10/28/proxies-for-work-as-done-1-work-as-imagined/\u003c/span\u003e\u003cspan address=\"https://humanisticsystems.com/2020/10/28/proxies-for-work-as-done-1-work-as-imagined/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e accessed 11 March 2024\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDhruva SS, Ridgeway JL, Ross JS et al (2023) Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators. BMJ Surg Interv Health Technol 5(1):e000167. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1136/bmjsit-2022-000167\u003c/span\u003e\u003cspan address=\"10.1136/bmjsit-2022-000167\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[published Online First: 20230123]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWilson NA, Tcheng JE, Graham J et al Advancing patient safety surrounding medical devices: barriers, strategies, and next steps in health system implementation of unique device identifiers. Med Devices: Evid Res 2022:177\u0026ndash;186\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVikkels\u0026oslash; S (2005) Subtle Redistribution of Work, Attention and Risks: Electronic Patient Records and Organisational Consequences. Scandinavian J Inform Syst ;17(1)\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"University of Leeds","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Electronic Data Processing, Patient Identification Systems, Equipment and Supplies, Hospitals, Healthcare Infrastructure, Capacity Building","lastPublishedDoi":"10.21203/rs.3.rs-6057343/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6057343/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: Data standards and barcoding technologies are implemented in hospitals to uniquely identify objects, people and locations, streamline the management of supplies and inventories, improve efficiency, reduce waste and improve patient safety and quality of care. The UK Department of Health \u0026amp; Social Care Scan4Safety demonstrator programme (2016-2019) had six hospitals adopt global data standards to address these aims. This study examined the implementation of Scan4Safety at one NHS demonstrator site to understand the hospital experience of adopting these standards, barcoding and related technologies.\u003c/p\u003e\n\u003cp\u003eMethods: Exploratory case study design, informed by information infrastructure theory, at one Scan4Safety demonstrator site. Semi-structured interviews were conducted with internal and external stakeholders, analysed thematically together with thematic analysis of documents related to the Scan4Safety programme.\u003c/p\u003e\n\u003cp\u003eResults: The NHS Trust Scan4Safety team was interviewed, together with senior roles in procurement, inventory, recalls management, nurses and surgeons (n=15), and senior roles in other demonstrator sites, NHS supplies, as well as GS1 - the organization responsible for the standards (n=4); 67 documents were analysed. Key enablers for Scan4Safety included: allocated funding, government role/regulation, executive buy-in/wide stakeholder involvement, patient focus, agile/adaptive approach and data linkage. Challenges were both internal and external, mainly pertaining to data quality, work-as-done, and trade-offs. Mechanisms of anticipated positive outcomes, and potential risks were also identified.\u003c/p\u003e\n\u003cp\u003eConclusions: Linked standards for identification of patients, products, places, and procedures, across supplies and hospital processes, constitute a wide-ranging information infrastructure with the potential for significant value to patients and the whole health system.\u003c/p\u003e","manuscriptTitle":"Complexities and capabilities of Scan4Safety in NHS hospitals: a qualitative study of a national demonstrator site","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-02-27 18:00:33","doi":"10.21203/rs.3.rs-6057343/v1","editorialEvents":[{"type":"communityComments","content":1}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"07659f34-aeea-463e-b162-34f1e22fc360","owner":[],"postedDate":"February 27th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":44518488,"name":"Health Policy"},{"id":44518489,"name":"Hospital Medicine"},{"id":44518490,"name":"Management"}],"tags":[],"updatedAt":"2025-02-27T18:00:33+00:00","versionOfRecord":[],"versionCreatedAt":"2025-02-27 18:00:33","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6057343","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6057343","identity":"rs-6057343","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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