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The Impact of Supply Chain Transformation in Health Systems Case Study: National Health Service, England Dr. Anne Snowdon RN, BScN, MSc, PhD, FAAN Chair, World Health Innovation Network Scientific Director & CEO, Supply Chain Advancement Network in Health Odette School of Business University of Windsor

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Table of Contents Introduction and Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Background and Context . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Leadership Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Global Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Patient Safety: “Putting Patients in the Driver's Seat”. . . . . . . . . . . . . . . . . . . . . 12 NHS eProcurement Strategy: Scan4Safety Program. . . . . . . . . . . . . . . . . . . . . . . . . . 13 Evidence of Impact and Return on Investment for the Scan4Safety Program . . . . . . . 19 The “Long Road” to Achieve GS1 Adoption . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Automating Inventory Management Processes to Reduce Waste . . . . . . . . . . . . . . . . 26 Automation: “Purchase-to-Pay”—“We All Talk the Same Language” . . . . . . . . . . . . . . 28 “The Perfect Order”. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Integration of Supply Chain into Clinical Practice and Clinician Workflow . . . . . . . . . . 32 Creating the “Single Source of Truth”. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Variability in Demonstrator Sites: Progress from Different Starting Points . . . . . . . . . . 40 Scan4Safety Outcomes and Impact: Return on Investment . . . . . . . . . . . . . . . . . . . . . 42 Cost Savings and Waste Reduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Visibility and Transparency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Labour Savings from Automated Recall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Supplier Outcomes: A Competitive Advantage . . . . . . . . . . . . . . . . . . . . . . . . . 50 Staff Accountability and Patient Safety Impact . . . . . . . . . . . . . . . . . . . . . . . . . 50 Catalyst for Innovation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Internal Supply Chain Optimization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Summary of Key Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

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Introduction and Background This case study is one of a series titled The Impact of Supply Chain Transformation in Health Systems. The purpose of these case studies is to examine real-world evidence of impact and progress of supply chain transformation in health systems, designed to achieve improved health system outcomes such as safety, quality and performance. Little is known, or has been documented, of how supply chain transformation has been implemented in global health systems, the return on investment of these initiatives or the evidence of impact achieved relative to health system performance. The following case examines the implementation of supply chain processes across the National Health Service (NHS) in England. This case provides an overview of the progress of the NHS, their leadership strategy, and the outcomes and impacts that supply chain transformation has had in advancing the performance of the NHS. The World Health Innovation Network (WIN) has been conducting research in health system supply chain and has been successful in establishing a global network of collaboration—SCAN Health—to disseminate and share knowledge and expertise relative to the implementation of supply chain strategy at the health system level. The five countries participating in the SCAN Health network are Canada, the United States, Australia, the United Kingdom and the Netherlands. The goal of SCAN Health is to mobilize knowledge and evidence of impact across global jurisdictions to advance progress of supply chain transformation in health systems. These case study findings have emerged from qualitative analysis of observations, public reports, online publications and key informant interviews of stakeholders across the NHS. All data excerpts cited in the case include combinations of direct informant responses in order to protect anonymity and confidentiality of participant responses.

Background and Context The NHS is a nationally governed health system under the leadership of the Secretary of State for Health in the UK government. The national governance structure is a key asset for health system innovation and change, as the highest level of government leadership is able to support health system innovation through various public policy frameworks, reporting requirements and funding models. The NHS has demonstrated substantial leadership, relative to other OECD health systems, with regard to its priority for strengthening patient safety and quality of care across the system. Secretary of State Jeremy Hunt has established a deeply impressive and very public strategy for transforming the NHS into the world’s largest learning organization, focused on scalability of best practice, transparency of reporting safety outcomes and quality of care outcomes across the continuum of care, from primary care to acute care trusts and community care. The goal underpinning Secretary Hunt’s strategy is to create a learning health system focused on advancing quality and safety across the system. This case study demonstrates the progress and impact of the NHS Scan4Safety strategy relative to the NHS objective of strengthening quality and safety across the system. The case begins by examining the key conditions that contributed to the implementation and outcomes of the Scan4Safety program across six demonstrator site trusts. The findings are informed by the many key informants who were generous in sharing their views, experiences and perspectives relative to the implementation and outcomes of the

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Scan4Safety program. The case findings include the engagement of four of the six demonstrator sites funded in this first phase of the Scan4Safety initiative. The case also includes key leaders from NHS trusts that have engaged similar supply chain strategies that are not part of the Scan4Safety program. Findings are based on a combination of key informant interviews (NHS leaders, procurement teams, Department of Health officers, clinicians and supply management teams), public presentations available online (e.g., YouTube), policy documents and conference proceedings. The case begins with the leadership strategy that was foundational to the Scan4Safety strategy, the core enablers, the three prescribed-use cases and the emerging findings related to this initiative.

Leadership Strategy The first phase of this research was to examine the leadership and policy drivers of the NHS strategy to better understand the conditions that prompted the most senior level of leadership in the UK government. In November 2013, Secretary of State Jeremy Hunt unveiled plans for a “profound transformation” of the NHS, aimed at addressing concerns over patient safety in the wake of the so-called Mid Staffs crisis. The Mid Staffordshire NHS Foundation Trust may be described as the sentinel event in the NHS system that brought substantial public attention to the patient safety and quality of care agenda. Between 2005 and 2008, there were an estimated 400 to 1,200 patient deaths linked to quality of care at Mid Staffs Trust. The NHS undertook a study of this trust, described as an example of a “total system failure” in the NHS system, documented in what is now known as the Francis report (1). A summary of the findings of this report offers insights into the key issues that informed the design and implementation of the NHS strategy endorsed by Secretary Hunt. Excerpts from the Francis report highlight the framework from which the current NHS safety and quality agenda has emerged. The following is a subset of the findings of the Francis report, which captures the system challenges in the NHS at the time: The report has identified numerous warning signs which cumulatively, or in some cases singly, could and should have alerted the system to the problems developing at the Trust. That they did not has a number of causes, among them: • A culture focused on doing the system’s business—not that of the patients; • An institutional culture which ascribed more weight to positive information about the service than to information capable of implying cause for concern;
 • Standards and methods of measuring compliance which did not focus on the effect of a service on patients;
 • Too great a degree of tolerance of poor standards and of risk to patients;

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• A failure of communication between the many agencies to share their knowledge of concerns;
 • Assumptions that monitoring, performance management, or intervention was the responsibility of someone else;
 • A failure to tackle challenges to the building up of a positive culture, in nursing in particular, but also within the medical profession;
 • A failure to appreciate until recently the risk of disruptive loss of corporate memory and focus resulting from repeated, multi-level reorganization. (2) The following recommendations were conceived, not as individual solutions, but as a collection of strategies that illustrate the goals and aspirations of NHS leadership: • Foster a common culture shared by all in the service of putting the patient first; • Develop a set of fundamental standards, easily understood and accepted by patients, the public, and healthcare staff, the breach of which should not be tolerated;
 • Provide professionally endorsed and evidence-based means of compliance with these fundamental standards which can be understood and adopted by the staff who have to provide the service;
 • Ensure openness, transparency, and candour throughout the system, about matters of concern;
 • Ensure that the relentless focus of the healthcare regulator is on policing compliance with these standards;
 • Make all those who provide care for patients—individuals and organizations—properly accountable for what they do, and to ensure that the public is protected from those who do not provide such a service; • Provide for a proper degree of accountability for senior managers and leaders to place all with responsibility for protecting the interests of patients on a level playing field; • Enhance the recruitment, education, training, and support of all the key contributors to the provision of healthcare, but in particular, those in nursing and leadership positions, to integrate the essential shared values of the common culture into everything they do; • Develop and share ever-improving means of measuring and understanding the performance of individual professionals, teams, units, and provider organizations for the patients, the public, and all other

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stakeholders in the system. (2) It is noteworthy that the Francis report informed the framework and approach for establishing a system-wide strategy for patient safety. Key themes in these findings, which are consistent with the findings of this case, include transparency in reporting safety outcomes to support system learning, and accountability for outcomes, disseminated widely through the public reporting of the quality outcomes of health services organizations (3). Public acknowledgement of both success and failures, which offer important opportunities for learning, is foundational to system learning and performance. An illustration of Secretary Hunt’s use of public reporting is captured in a video on patient safety (4). Secretary Hunt describes clear evidence of the NHS strategy and the commitment of senior leadership to realizing the goal for advancing safety and quality across the NHS health system: We still have two examples of wrong-site surgery every week, across the NHS, two examples of foreign objects left in people’s bodies every week. We still have, according to the Hogan and Black report, 150 avoidable deaths every week, and we still have, according to the Freemantle study, a weekend effect which sees mortality rates for weekend admissions about 15 percent higher. Now I know there has been debate about statistics. … Let’s not make the mistake at Mid Staffs debating the methodologies, and we didn’t get on with improving care for patients, and we mustn’t make that mistake again. (4) The NHS system-level strategy is unique among OECD countries, given that the focus is on driving change across the entire health system. Hunt states that “no other health economy in the world is taking a root and branch approach to patient safety” to transform the system to become the safest and highest-quality health system in the world. Although safety and quality outcomes are the key drivers for the NHS strategy, there is also an acknowledgement of the economic imperative of transforming health systems towards improved quality and safety for patients: I have to spend $1.3 billion every year on litigation claims. Other studies suggest £800,000 is the cost of unsafe care; just one example is hospitalacquired UTI, £69 million every year. (4) The NHS strategy has focused on a comprehensive solution to achieve the safest health system in the world. One of these strategic enablers is the early identification of problems, or potential for risk, that is critical in strengthening patient safety outcomes across the system. System transparency is another key component of Hunt’s strategy in transforming the culture of safety across the NHS. In the fall of 2014, it was announced that the NHS is the first global health system in the world to publish surgical outcome data online, to “put patients in the driver’s seat” (4). Quality and safety across the NHS is a key strategy supported by transparency to document evidence of improvement in quality and safety, from which many other global health systems can learn. (5) The publication of the Personalised Health and Care 2020 report (6) outlined a framework for exploiting the use of data and technology to enable people to make health decisions, to be “more resilient” and manage illness and disability more

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effectively when they arise, empowered by a health system in which technology helps tackle inequalities and improves access to services for the vulnerable. Another key focus of the NHS strategy was informed by the Carter report (7), which focused on the prevalence of unwarranted variation, a key contributor to costs due to lack of standardization of care across the NHS. The costs of variability across the NHS described in Lord Carter’s review are shown in Table 1. Table 1. Unwarranted variations in operational productivity and performance of English NHS acute hospitals Unwarranted variation We looked at the key resource areas of clinical staff, pharmacy and medicines, diagnostics and imaging, procurement, back-office functions, and estates and facilities. We also looked at quality and efficiency through the lens of clinical specialties. Examples of the variation we found include: Overall non-specialist acute hospital costs Average cost of an inpatient treatment is £3,500 but there is 20% variation between the most expensive trusts (£3,850) and the least expensive (£3,150) On the ward Average 9.1 hours of care provided by registered nurses and health care support workers per patient day but variation from 6.33 to 15.48 hours, although we should be mindful of comparing different types of wards and trusts In the operating theatre (Orthopedics) Deep wound infection rates for primary hip and knee replacements currently range from 0.5% to 4%. If all hospitals achieved 1% this would transform the lives of 6,000 patients and save the NHS £300m per year Procurement Average price paid for hip prosthesis varies from £788 to £1590, and trusts buying the most are not paying the lowest price In the pathology lab Pathology providers are considered productive if the cost of pathology to the trust is less than 1.6% of operating expenditure. Data gathered suggests a two-fold variation in the current cost—from 1.1% to 2.4% In the medicine cabinet Stockholding varies from 11 to 36 days, and if everyone achieved 15 days this would save £50m HR Department Sickness and absence rates vary from 2.7% to 5.8%. This is a variation of 116% On the hospital estate Total estates and facilities running costs per area (£/m2)—trusts are considered good if their metric is lower than £320, the current variation is between £105 and £970; if everyone achieved the media this would save £1bn per year. Non-clinical space (% of floor area)— trusts are considered good if their metric is lower than 35%, the current variation is between 12% and 69% Source: Department of Health and Social Care. 2015. Operational Productivity and Performance in English NHS Acute Hospitals: Unwarranted Variations, p. 6.

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The Carter report highlighted the costs associated with variability in procurement of products, variation of how facilities and estates are operated and variation in the cost of delivering patient care. This report proposed a potential cost savings of £1 billion related to reducing variation through standardization of processes in acute trusts, not only to improve safety and quality, but also to reduce the costs associated with variation in care delivery processes. The magnitude of variability in supply costs is captured in the Carter report: In procurement we found astonishing variety in the numbers of products and suppliers used across and within trusts. A sample of 22 trusts use 30,000 suppliers, 20,000 different product brands, over 400,000 manufacturer products codes and more than 7,000 people are able to place orders. (7) (p. 7). The Carter report identified the opportunity for standardizing processes across the health system to achieve greater efficiency, collaboration and cooperation across trusts to strengthen performance and reduce waste across the NHS system. The engagement of the Department of Health, NHS England and NHS Improvement were key constituents identified as enabling the NHS to reduce variation and improve patient care processes, while at the same time achieving cost savings, estimated at £1 billion across the system. The Carter report identified the support and recognition among many trusts as the opportunity to achieve value by optimizing processes across the NHS system. Specifically, recommendation 5(c) stated: Trusts to aim to work in collaboration both with national procurement strategies and other trusts to explore common systems adoption, e.g. efficient electronic catalogues using retail system standards, enhancing current purchase-to-pay systems, adopting (GS1) and Pan-European Public Procurement Online (PEPPOL) standards detailed in the eProcurement Strategy, and to align with NHSSC on category initiatives. (7) (p. 48) The findings of in-depth reports and investigations (i.e., Carter report, Francis report), and decisions at the most senior levels of UK government, set the stage for a systemwide strategy to transform supply chain processes to achieve quality and safety outcomes, reduce unwarranted variation, and contribute to realizing the projected cost savings potential for the NHS system. In April 2014, the Department of Health published its NHS eProcurement Strategy that included mandating all NHS health Trusts to adopt GS1 standards and PEPPOL standards within three to five years (8). In June 2015, the Department of Health received approval to create six demonstrator sites to showcase the adoption of GS1 and PEPPOL data standards in healthcare, a recommendation of the NHS eProcurement strategy (5). The strategy was led by the eProcurement and Inventory Management team of the Department of Health. The goal of the strategy was to advance patient safety by developing the capacity for recall of products right to individual patients, and implementation of eProcurement infrastructure (adoption of GS1 and PEPPOL standards) to achieve cost savings. The introduction of this policy, is described by Dan Poulter, Parliamentary Under Secretary of State for Health: [T]o realize procurement improvements … we … are determined to deliver efficiencies to free up more money for frontline care. To ensure that these

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new efficiencies are sustained and further improved upon, I am announcing this NHS eProcurement strategy, which will establish the global GS1 coding and PEPPOL messaging standards throughout the healthcare sector and its supporting supply chains. Compliance with these standards will enable trusts to control and manage their non-pay spending, by the adoption of master procurement data; automating the exchange of procurement data; benchmarking their procurement expenditure data against other trusts and healthcare providers. We have now mandated the use of the GS1 and PEPPOL standards by amending the NHS Standard Contract to require compliance with this NHS eProcurement strategy. We have also required suppliers to place their product data in a GS1 certified data pool by amending the NHS Terms and Conditions for the Supply of Goods and the Provision of Services. (8) (p. 5) The challenge of driving change across an entire health system is daunting for leaders. The following excerpt highlights the many challenges health systems experience when driving towards change and transformation at the system level. It underlines the range of experiences in the NHS system and the importance of system-level transformation engaging clinicians, who ultimately determine whether meaningful change is delivered for patients receiving care on a daily basis, described by Lord David Prior, Parliamentary Undersecretary of State for NHS Productivity: The most important issue that we face is how do you get improvement and change into an organization like the NHS? Now we have used targets, and of course targets have a role, but the engagement in many of those targets, the gaming that goes around targets. … We’ve tried decentralization to try to get greater, what we call, “earned autonomy” through foundation transfer and CCGs, but of course the perverse impact of that, the unintended consequence, is that it makes it much more difficult to have an integrated system of care because everyone is looking after their own patch. We’ve tried top-down performance management, we’ve tried choice, we’ve tried competition, but the market does not work in healthcare. The market is so perfect that we can never rely on the market the way you can in retailing and car manufacturing. We’ve tried regulation through financial regulation, quality regulation through the CCC, and you end up with a culture more around compliance than improvement. So, where it leaves us, having been in the NHS and having lived through the NHS and all these methods that we’ve tried, is that I think the way forward is to expose unwarranted variation. And one of the reasons [is] that I believe it’s one of the most powerful levers for improvement, and is the only way that I believe we will get true clinical engagement. Because … if we cannot engage clinicians, we will never get true improvement. We may get short-term improvement though targets, for example, or short-term through regulation, but to get long-term sustainable improvement, we need clinical engagement. (9) The Department of Health leads the program, providing support to the NHS supplier community and engaging technology providers to adopt GS1 and PEPPOL standards. The Department of Health has oversight over the progress of the strategy with comprehensive review processes to document completion of each phase of the strategy at each demonstrator site. Early learnings from the six demonstrator sites resulted in the

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adoption of a re-branding strategy, formerly known as “GS1 and PEPPOL adoption,” to “Scan4Safety.” The local teams in each of the six sites learned very early that in order to engage clinicians in adopting the standards, the program had to be viewed as clinically relevant. Hence, the Scan4Safety brand supported and engaged clinician teams based on the branding that linked supply chain transformation to patient safety. The plan was to start with six demonstrator sites and use the learnings from the first sites to inform the next phases of implementation: What we’ve developed is three enablers and three use cases, and we’ve got a document for each of them: This is what you need to do. Here are your goals. Here is your time. … And four phases, and then when you’ve done that, move on to the next one. And so that is a very basic model of franchise, if you like. And it’s very much the learning piece with these things, so we can learn and develop it. We go to the next group of 25, and push that learning into those 25, and then we go to the next group of 25 after that. [The process] should be repeatable. So, the next 25 will be a learning still, you know, just to refine. So, if we go out with 65 percent of the learning, now we can get the rest, maybe another, get it up to 90 percent. (Supply chain leader) Each of the six Scan4Safety sites was provided with £2 million to support the implementation of GS1 and PEPPOL standards from January 2016 to March 2018. In the three demonstrator trusts who participated in this case study, board-level leadership was perceived as centrally important to the successful implementation of the Scan4Safety program. The boards of each trust were educated and aware of the progress, outcomes and opportunities for the entire Scan4Safety initiative. This was a strategy that was viewed as very important to bring a “ward to board” perspective to the strategy. Safety was an important driver for the initiative. In addition to the Mid Staffs crisis, another event that influenced the NHS strategy was the horsemeat scandal in the food system; the food industry could trace the meat in a matter of hours, yet the NHS remains unable to identify 30,000 women who have received defective breast implants. The second driver was cost savings—specifically, cost savings due to waste from expired stock in inventory—and time savings from clinical staff who are now doing inventory work but whose clinical expertise would be better served if their work time were allocated to patient care. The mandate for GS1 and PEPPOL standards adoption supported digitization of product procurement and ordering processes by amending the standard NHS contract (funding contracts for organizations), stating, “the provider must comply with eProcurement guidance.” All NHS suppliers must use a certified data pool to support automated eCommerce processes that offer “no touch” ordering, processing and receiving product orders using pan-European (PEPPOL) standards for invoicing and purchase-to-pay processes: The ambition is for all NHS purchase-to-pay transactions and all category management activities to be undertaken by electronic means, to cover all non-pay expenditures … to make procurement faster and more efficient. … [M]any procurement processes flows are fragmented across multiple supply functions, including supplies, pharmacy, pathology, sterile services, appliances, estates, catering and cleaning services. (8) (p. 10)

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Specifically, the eProcurement strategy requires medical device manufacturers to comply with GS1 and PEPPOL standards by placing two unique identifiers on their products: a device identifier (manufacturer name and device product code) and a production identifier (batch number, expiry date and serial number). Products are scanned at the point of receipt by the health organization, again at point of storage (inventory), and again at the point of use during patient care procedures. This product scanning strategy enables NHS teams to have a digital record of accurate and comprehensive product information tracked and traced from manufacturer to individuals when uploaded into patient records. The Scan4Safety program requires suppliers to identify and label every individual product using global standards, and also requires hospital trusts to capture and track every product used in care, uploaded and recorded in patient care records. In the event of a product recall by the manufacturer or the NHS, products are automatically tracked to individual patients to notify them of the recall and enable clinician teams to respond to risks the recalled product may pose for patients. This strategy aligns with the EU Falsified Medicines Directive (FMD), implemented in 2011, which requires compliance by pharmaceutical manufacturers and hospitals by February 2019. (10) The FMD requires the adoption of global standards by suppliers relative to product identification and labelling on packaging, together with barcode scanning of medicines by all trusts. The Scan4Safety program aligns very closely with this FMD directive, implemented in 2011.

Global Standards GS1 is a not-for-profit global organization currently located in 114 countries worldwide. The standards enable globally unique identification of people, products and places, enabling capture of unique event data through technologies including barcode scanning, radio frequency identification (RFID) and other technologies. Data is captured through barcode scanning or sensing of RFID tags. Once captured, event data is shared electronically across systems to provide interoperable transactions and searchable digital records. GS1 barcodes are used every day by consumers in retail, grocery, pharmacy and many other settings. In Europe, new regulations for Medical Devices (MDR—Regulation (EU) 2017/45, published May 5, 2017) and In-Vitro Diagnostic Devices regulations (IVDR—Regulation (EU) 2017/746, published May 5, 2017) were released, requiring health systems to further strengthen requirements for clinical investigation of medical devices that were designed to advance European cooperation and control for monitoring devices in health systems. The regulations were focused directly on improving the traceability and transparency of product utilization in health systems, leveraging UDI for product identification based on GS1 standards. These legislative requirements further supported and aligned with NHS leaders’ strategy and vision. In addition, automating and digitizing transactions were supported by the adoption of PEPPOL standards. PEPPOL is a notfor-profit European organization that deploys European electronic document standards to enable machine-to-machine exchange of data between buying (e.g., NHS trusts) and selling organizations (e.g., Supplier Community, including medical device manufacturers, pharmaceutical companies and distributors). PEPPOL standards are used by several European countries for electronic invoicing between suppliers and the public sector.

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Patient Safety: “Putting Patients in the Driver’s Seat” A strategic objective of transforming the NHS system is the focus on “putting patients in the driver’s seat” (4) by informing patients of quality and safety outcomes so that they may make informed decisions on where to seek care that is safe and of high quality. Similarly, a key leadership driver of the eProcurement strategy was patient safety, specifically the automated recall of products linked to individual patients: • Of the top 20 risk factors for all deaths [in the UK], adverse in-hospital healthcare events come [rank] eleventh—[which is] above alcohol, drugs, violence and road traffic accidents. … • Every week—two wrong-site surgeries and two operations with kit wrongly left inside. NEVER EVENTS 2016/17= 400 • Wrong-site/retained foreign body/wrong implant = 79%; Medication error causing harm = 12% (NHS clinician leader) (11) The same speaker has further stated: There’s a denominator as well as a numerator. The numerator is the number of things that go wrong; the denominator is the phenomenal amount of work which the NHS undertakes in a year, … over 600 million prescriptions. … I was prescribing last week during the junior doctor strike, and I tell you, every time you’d make a prescription name, hospital number, date of birth, dose milligrams/micrograms, oral, IV, there’s multiple places you could make a mistake. Three hundred million GP visits, 30 million outpatients, 5 million people admitted, and almost 3 million emergency ambulance calls. (12) The NHS leadership has taken a whole-system approach to their safety and quality strategy, recognizing that much of the care that citizens receive (90 percent) is in community and primary care settings. Hence, supply chain tools that enable tracking and tracing of patient care across the entire journey of care is foundational to system transformation. Capturing the perspective and input of patients relative to safety outcomes is a gap in knowledge that supply chain leaders believe should be captured in reporting systems: One of the points that I’m trying to get across more and more is that our reporting structures in terms of what error occurs, particularly on the basis of the areas we’re talking about now, are often related to the recognition of those errors, by another clinician or the clinician delivering the care. But we rarely ask the patient whether they believe the impact on their safety has been no harm, low harm, moderate harm or severe harm, which are our classifications. We rarely ask the patient—in fact, we hardly ever ask the patient. And so… one of the key changes that we are trying to introduce into a sort of cultural space is to involve the patient more and more, and actually, the determination of the degree of harm. (Supply chain leader)

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Leadership strategy and policy frameworks documented in the many reports provided the framework for implementing what is now known as the Scan4Safety program. The structure and operational strategy for this program is described in the following section.

NHS eProcurement Strategy: Scan4Safety Program The NHS’s eProcurement strategy is focused on system-level standardization and clinical engagement, aimed at reducing variation to improve safety and reduce health system costs. This strategy was re-branded shortly after implementation commenced, and is now known as the Scan4Safety initiative: The Department of Health have mandated that all trusts need to adopt the GS1 standards and the demonstrated sites have to do it in two years, and others within three to five. And the three core areas, first of all, are obviously using the GTINs [global trade item numbers]. Patient ID bands need to be GS1-compliant, and then the global location numbers, so in a hospital, all your rooms need to have a global location number. Obviously, you need to be a member of GS1, so you have your organization location number, and you need to have a strategy for building them, and then you are able to scan a patient, scan a product to a patient and the location. (Supply chain leader) The Scan4Safety initiative, although mandated and funded through the Department of Health, is not sanctioned and does not have legislative power behind it. This creates a risk of hospitals’ noncompliance with the new mandate: The Scan4Safety program is from the Department of Health. It’s their mandate, but there’s no sanction. So I remember a very famous meeting, and the problems out there, and a very senior bloke of the London Trust said, “Okay, I’ve listened to you for four hours, so can I just clarify that if I do nothing, in three years’ time, somewhere on the Internet there’ll be a red dot and you might send me a strongly worded letter?” To which the officer said, “That’s about it.” And he said, “Thanks very much,” and that was that. [The individual left the meeting and declined to participate.] (Supply chain leader in a non-Scan4Safety hospital trust) The Scan4Safety program essentially creates the infrastructure in clinical settings to make it possible for clinicians and teams to identify potential error or safety risk for patients by adopting global standards for identifying products, patients, providers and locations of care. Scanning these components enables and informs clinicians of the care a patient has received, where, and by what provider team, as well as the potential risk for patients (e.g., risk of an expired product, or of wrong-site surgery). The key characteristics of the Scan4Safety strategy include a standardized, modular approach to the adoption of GS1 and PEPPOL standards, with four defined phases for implementation that include a core set of milestones for each phase. The governance structure includes a review panel and a standardized assurance process that measures compliance via a neutral and repeatable approach. The program structure is described by the Department of Health leader as a “franchise model” approach to ensure that

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every NHS trust adopts the same program structure and key enablers to ensure system-wide consistency and standardization. As each of the four phases of the strategy is completed by the participating trust, a Phase Review Panel examines progress and compliance with the milestones for each phase during site visits, and then funding is authorized. The goals of the Scan4Safety program are defined as “Patient, Product, Place and Process.” The foundation for the Scan4Safety program is the adoption of GS1 and PEPPOL standards to create the infrastructure in clinical settings to track and trace products, patients, places and process of care to improve accuracy and efficiency of health services, and it is envisioned ultimately to improve patient safety as follows: • • • •

Patient—improving safety, improving care Product—everything recorded, everything accounted for Place—everything trackable, everything traceable Process—simplifying processes, releasing time to care for clinicians (13)

The goals and objectives of the Scan4Safety program are designed to improve patient safety, increase clinical productivity and realize operational efficiencies across the NHS. The adoption of global standards supports the key enablers of the Scan4Safety program: • Right Patient: Standards identify patients to know what product was used with which patient and when. • Right Product: Track products to ensure have the products they need for patient care when it is needed. • Right Place: Standards ensure that patients and products are in the right place. • Right Process: Standards and common ways of working deliver better patient care that is repeatable. (14) To implement Scan4Safety, a call for expressions of interest was disseminated to all NHS trusts to engage those trusts interested in participating in the first phase of the program. Six demonstrator sites were selected from 28 applications to participate in the strategy. The Department of Health used a rigorous evaluation that included a panel of expert reviewers to assess the expressions of interest and select the first demonstrator sites. The following NHS acute care trusts were selected to participate in the Scan4Safety program through a competitive bidding process to demonstrate the impact of the program in healthcare settings: • • • • • •

Derby Teaching Hospital NHS Foundation Trust North Tees and Hartlepool NHS Foundation Trust Royal Cornwall Hospitals NHS Trust The Leeds Teaching Hospital NHS Trust Plymouth Hospitals NHS Trust Salisbury NHS Foundation Trust

These six demonstration trusts commenced with implementing three core enablers and

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three specified-use cases. In this phase of the Scan4Safety strategy, the objectives focused on supply chain optimization, described as enabling clinical productivity and creating the necessary foundation for patient safety: •

Core Enabler 1: Location Identification. The first core enabler focused on establishing a single data standard for location identification across the entire NHS, using the GS1 Location Numbers (GLN). The goal is for all trusts (eventually) to implement GLN standards to improve efficiency and reduce clinician time required for investigations. This enabler improves the quality of data, facilitates exchange of information with suppliers and service providers (e.g., inventory is delivered to the correct location using the GLN) and enables improved equipment and facilities management and infection-prevention monitoring.

Core Enabler 2: Catalogue Management. This core enabler uses the GS1 global trade numbers (GTIN) captured in barcodes to identify unique products. The trusts depend on manufacturers of products to adopt and implement GS1 standards. The trusts must demonstrate the ability to receive and capture GTIN data in both their inventory systems and their patient record systems. Trust IT systems must be GS1-compliant and be able to analyze the data to demonstrate effective catalogue management (e.g., inventory management) in each clinical unit in the trust. There is evidence that few, if any, trusts are fully compliant with GS1 standards, resulting in limitations in trusts’ ability to compare product and price information. A limitation in the current progress towards full compliance is the level of manufacturer compliance with adoption of GS1 standards (i.e., use of GTIN to identify every product in the catalogue). Updating catalogue management processes with GTIN information ensures that accurate and consistent product information is used consistently across the NHS.

Core Enabler 3: Patient Identification. This enabler requires the implementation of uniform identification standards for patients, which place a barcode on every patient identification band using Global Service Relation Numbers (GSRN) at the time of admission. The GSRN provides more robust patient information and enables the use of two-dimensional (2D) barcodes for scanning. Adopting GSRN for patient identification enables accurate identification of the patient, linkage to product identification (GTIN) to support recall, and identification of patient outcomes, once the program is fully implemented.

The three core enablers facilitate the intended operational efficiencies: In essence, if you can’t have a wristband, then you can’t scan it [at the point of care] and allocate a product. And if you can’t allocate a product to a patient record, or a cupboard, then you can’t do process to recall, which is a primary use case, which is why the core enablers are so important. Because if you haven’t got those three, you’ve no chance. (Supply chain leader, NHS trust) Once these core enablers are in place, the demonstrator sites were then required to demonstrate the three prescribed-use cases, which included automated eProcurement processes:

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Use Case 1: Inventory Management. The first prescribed-use case leverages utilization of the GS1 data standards for people, products and places in order to manage product inventory levels more effectively in each demonstrator site. The Carter report showed the wide variation in how inventory is managed within and across the many clinical units in each trust. Many trusts manage inventory manually, a process that is highly inefficient and does not track or trace items across the organization. This case demonstrates the use of digital inventory management systems that link product purchase to utilization in patient care (thus reducing waste from expired products) or product packages opened but never used. This approach improves visibility and quality of inventory data to reduce inventory and waste; it also automates procurement processes and efficiently identifies recalled products across the system.

Use Case 2: “Purchase-to-Pay.” This prescribed-use case requires the automation of ordering and invoicing processes between the trusts and their manufacturers and suppliers. The goal is fully automated, digital (“no touch”) ordering, receiving and invoicing processes with suppliers through the use of PEPPOL standards. This automation of processes is believed to support the reduction of labour hours in trusts, as manual processes are reduced or eliminated altogether, resulting in substantial cost savings across the system. Automated ordering and invoicing may also reduce costs for suppliers, who are required to manage many processes manually, such as phone orders and faxed orders, which are common with the high prevalence of current manual systems across the NHS.

Use Case 3: Product Recall. The third prescribed-use case focuses on the ability of the trust to track and trace products and drugs from manufacturer to individual patient in the event of a recall. This approach responds to significant high-profile events, such as horsemeat in the food supply or the recall of defective breast implants. When there is a lack of product information in patient records and products are recalled, clinicians must search manually through thousands of patient records to identify people who may have received or been exposed to a recalled product. This case requires that product information (unique product identification, including lot/batch or serial number) be captured by scanning the product barcode at the point of care, which enables product information to be uploaded to the patient record digitally. The ability to link product identification to individual patient records supports automated recall that quickly identifies every patient who has received the recalled product.

Recall is the primary prescribed-use case for the NHS, influenced by the horsemeat and breast implant scandals, which demonstrated that the system was unable to identify products that were used for individual patients in the event of a recall. Adoption of global standards enables scanning of all products used during care for any patient in the entire NHS system. Such patient safety reporting has great magnitude and relevance: We’ve got nearly 14 million reports within the national reporting learning system. We’re collecting about 1.8 million reports a year now, of which 100,000 or so are related to moderate to severe harm, including death. Of that, 0.6 percent of all our reports are related to severe harm and death,

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and of that, of the moderate harms, I guess that’s just under 100,000 moderate harms. (NHS leader) Each of the six demonstrator sites worked towards key stage gate deliverables for each phase of the Scan4Safety program. As each phase was completed, the trust demonstrated each of the required enablers and prescribed-use cases during onsite review team visits established by the Department of Health team. Successful completion of each of the required phases resulted in approval of funding for each trust to support the implementation of the program phases: Of course, if they don’t hit their mark, their phase one milestone, they don’t get phase two money. If they don’t hit the phase two milestone, they don’t get [the funding]. (Supply chain leader) Safety is defined by the ability to identify, quickly and efficiently, any products that may pose risk due to expiration or recall. The efficient and automated recall of a product in the event of product failure is the primary safety strategy of the Scan4Safety program: The reason the staff are doing this is if we have a product recall, which we’ve had, we spend 12, 14, 16 weeks with a team of 12 people at least running around looking at clinical records. At the end of doing that … we still can’t identify all the patients [who have received a device or implant]. [During] the horsemeat incident, supermarkets moved all of the horsemeat within two hours, and we should be able to do the same. … When we started this, we didn’t even know what stock we had on the shelves, and then found out we had something like two weeks’ worth of stock on the shelves, and it’s a ridiculous amount. So, this is why we started the journey. … There’s the patient, the product, and the place, so we’re using the GS1 standards to do this. All of our wristbands now have a GS1 barcode on. Products are a bit more difficult, and we’re just getting supplies on board, … so we’ve got GLNs on the walls. (Supply chain leader) Safety and risk are defined by the Department of Health in terms of failures of the supply chain, such as recalls and the increasing numbers of counterfeit medicines and devices that make their way into care settings. A significant amount of clinical time is too often diverted to managing inventory and safety recalls in clinical settings, resulting in lost time for clinicians to provide care for patients. The Scan4Safety strategy is designed to reduce the need for clinicians to spend time on non-clinical tasks, such as ordering products and managing inventory. One of the outcome measures for the program is the amount of clinician time (labour hours) being returned to caring for patients. The implementation of GS1 and PEPPOL standards requires the structuring of master data attributes and coding of products to enable the tracking and tracing of medical devices, pharmaceuticals and other products used in patient care. Suppliers are required to fulfill three components: (a) labelling with GS1 barcodes, (b) digital purchase-to-pay processes using PEPPOL standards and (c) identification of product data and attributes to support safety for patients.

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Suppliers are required to place their data into a GS1-certified data pool, accessible by the NHS and NHS trusts for full interoperability and transparency across the NHS systems (8). The NHS believes that by aligning its trusts with GS1 and PEPPOL standards, trusts will be able to adopt a master procurement data list, automate procurement data and benchmark procurement expenditures against other trusts and provider teams (8). This strategy is designed to curb spending and drive patient benefits, tracking medicines and medical devices to specific patient outcomes (8). Over time, each NHS trust has adopted its own approach to supply chain, geared to local needs and requirements. The adoption of GS1 and PEPPOL standards is perceived to unify trusts to support improved patient outcomes. The PEPPOL framework supports automation and digitization of procurement processes, generates robust data for analysis and creates evidence of efficiency, cost and effectiveness. Across the trusts, data systems, data quality and data standards vary widely. Manual processing of data has resulted in inconsistency and inaccuracy in past data catalogue processes, causing fragmented data collection and lack of access to analytical capacity: There are two fundamental issues: data systems and people issues. In terms of data, we have varying levels of data quality and understanding of the data standards for good procurement. We have a lot of manual transaction processing still, which leads to inconsistency across the systems. We’ve limited use of standardized catalogues and low investment in analytical tools. We often have very complex contractual arrangements, which are not always monitored and therefore not enforced. And in terms of people, we do not employ many dedicated data analysts, so we do not always have access to the analytical capability. We’re fragmented, and our attitude is that we believe we each get the best deal and we must protect that from competition. (15) As this supply chain leader suggests, data is a key asset to inform procurement processes and decisions, such as contract negotiations and benchmarking: As my colleagues have said, very few of us actually compete on price, and the only competition that has truly benefited from the situation is the supply chain. So, good reliable data forms the basis for all procurement activity and should drive the opportunity assessment, and our proposition to you today is that benchmarking should be the core tool for any procurement team … rather than us all doing this individually. (15) The Department of Health is piloting a master data validation and sharing services strategy to receive product data from GS1 data pools via GDSN, validate the data and share with NHS trusts directly (8). The value of this strategy is to ensure there is an accurate product item master that is accessible to all trusts, and identifies the product attributes of every supplier product accurately and transparently, including pricing data. To receive the data, technology used by the trusts must be interoperable with the NHS and is supplier based, a cost that is paid for by the trust (8). Data sharing has been difficult in the past, as trusts are often reluctant to share information for fear of helping competitors: In November of this last year, Ernst & Young found significant reluctance in trusts to share information. As for the top quote from [name] partner, …

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trusts are reluctant to share information over the fear of helping their competitors, and in our benchmarking survey carried out last month, it is clear from the quotes that we’ve highlighted here that everyone understands the need for better and more transparent data. So why do we have this problem? (15) Future prescribed-use cases in later phases of the strategy focus on clinical productivity, which includes procedure case costing, eMedicines and asset management. In the planned future phases of the strategy, patient safety is the primary objective, and prescribed-use cases include iatrogenic conditions, “never event” reduction and outcome analytics. Once this current phase is completed by the six demonstrator sites, the next phase plans to engage 25 NHS trusts for implementation of the Scan4Safety program, to be completed by 2019. The NHS plan includes onboarding trusts in groups of 25, phased in gradually, with completion by 2021, when all 154 trusts will have implemented the Scan4Safety program. The program, fuelled and informed by the NHS policy frameworks, has now been successfully implemented in all six demonstrator sites, awaiting approval of funding to proceed with phase 2 engaging the next 25 trusts. This section has focused on the empirical evidence (qualitative and economic) of impact and outcomes emerging in a subset of these demonstrator sites. The next section profiles the evidence of impact and return on investment as each site was nearing completion of the project milestones and deliverables.

Evidence of Impact and Return on Investment for the Scan4Safety Program Key stakeholders in four of the participating trusts described their experiences and lessons learned as they implemented the three core enablers and demonstrated the three prescribed-use cases required for the Scan4Safety program. Supply chain teams described both the challenges they faced, the value and the impacts emerging from this initiative. The trusts varied widely in size, specialization of care delivery, Care Quality Commission ratings, supply chain and IT infrastructure. Despite variation across the individual trusts, common themes emerged across participant interviews that highlight the experiences, challenges, lessons learned, return on investment and impacts of the Scan4Safety program for three demonstrator sites. The following sections describe the emerging themes documenting the progress of the program.

The “Long Road” to Achieve GS1 Adoption The EU legislation has required adoption of global standards by suppliers to be completed by 2020. The supplier community is working towards meeting these legislative standards, while at the same time, the trusts were learning the complexity and challenges of this process. In each of the trusts, the supply chain staff underestimated the challenges of achieving adoption of GS1 standards, which relied heavily on the suppliers to identify products with GS1 barcodes and provide the required product attribute information necessary to support safe patient care.

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Trusts believed initially that adoption and implementation of the Scan4Safety program was relatively straightforward. The supply chain teams would implement the required key enablers for the program and demonstrate the prescribed-use cases. These expectations changed: We’ll just bring [Global supplier name] in and say, “You’ve got to change the barcode on your product, please. And you’ll do it, won’t you?” No. And that’s why. … With GS1, I can engage with these companies. We engaged because we realized that although we know locally what to do, we had to engage globally in order to change anything, and it’s been a long journey. (Supply chain team leader) One of the trusts realized just how challenging it was to implement the catalogue management strategy: We got the go-ahead to implement an inventory management solution, and clearly, lots of people were saying to me, “Why can’t it work like a supermarket?” So very, very quickly, we established just in one [operating] theatre storeroom that we had two products from two different suppliers with the same barcode. So, we were like, “We’ve got a major problem. We’ve got this fantastic technology and we’re not going to be able to use the barcode.” (Supply chain leader) To overcome these challenges, supply chain teams generated barcodes from their IT systems to track inventory. However, when the products were placed in clinical settings (e.g., surgical theatres), barcodes would not scan. Supply chain teams sought consultation from inventory solution providers: We realized what a massive problem it was, so what we did is we produced barcodes out of our system and put them onto the shelves so that we could make our system as efficient as possible to work things through. And then … this is in [operating] theatres … when we went into cardiology, a lot more products had barcodes on them—some GTIN, some HIBC [Health Industry Bar Code]—and basically, we found about 13 different types of barcode, all sorts of concoctions of barcode. So, we got our inventory management solution provider to come in and look at all the problems we had, and they obviously tweaked the software so that it could strip out the stupid characters like “%” and “*” and so on, so it could read the barcode we needed. I needed to implement it so that when I got to a clinical person who didn’t want to do this and I need to make it easy for them, [who would complain] “Oh, it doesn’t work, the system doesn’t work,” because you get that a lot. (Supply chain team leader) For some of the demonstrator trusts, adoption of GS1 standards had begun prior to the start of the Scan4Safety program. Consistent across all of the trusts, the greatest challenge faced was engaging suppliers to adopt GS1 and provide accurate, GS1compliant barcodes on every product. Trusts first engaged their supplier community to survey how many were GS1-compliant:

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We agreed in April 2013 to work formally with GS1, and in April 2013 they wrote to our top 30 suppliers and asked them where they were on their GS1 adoption journey, on our behalf. And so, the stats coming back from that looked pretty good. It looked like 69 percent of them were on a journey or had a plan, but when we did some analysis … a month later, we found that it wasn’t like that at all. It was about 37 percent. (Supply chain leader) The supply chain teams worked closely with suppliers, particularly smaller suppliers who had limited expertise or capacity to learn how to implement GS1 standards. The result was that products could not always be scanned at the point of care due to faulty barcodes, missing barcodes or barcodes that were not legible: I mean, the bottom line is, it looked more promising than it was, but the onthe-ground stuff didn’t reflect what [suppliers] were saying. And if I jump to … now, [I’ll] just tell you quickly that we still have those problems. We’ve got suppliers where you could say… they’re a GS1 member, they have GTINs, they seem brilliant, and when you scan their barcodes they’re fantastic. What we found the other week is a major global company like [company name], every time they’re producing a new batch, they’re changing the GTINs, which is wrong. We also find within the barcodes, the GTINs—I don’t know if you know the core structure of them—but there’s what’s called “application identifiers” within them. So, a certain part of the barcode should show a serial number, … the expiratory date serial number. Sometimes they’ve got them in the wrong place, so then it won’t scan because it is not constructed properly. (Supply chain leader) The realization that suppliers were not readily able to comply with global standards adoption sparked the trusts to consider a variety of options to engage suppliers and work with them to accelerate adoption: What we’ve been trying to do is work with the suppliers so they put the GTINs on the products, but it takes some considerable time. We’ve got good working relationships with a lot of the multinationals … and we’ll put all new barcodes on for you, so anything that’s got the old HIBC code, we’ll remove those and put new ones on. They took one look and said, “No, we can’t do it.” They had governance problems … because they were manufactured all over the world and had different barcodes, dependent on geographic location. When asked about how they engage and work with the supplier community, one supply chain team member replied: What we do is … we share the [Department of Health] mandate. Most of them that were in the room … they know a little bit, or they’re not quite sure what we’re talking about. They’ve heard about it, they don’t know an awful lot of details, so we share with them the DH mandate, the eProcurement strategy. [Staff name] goes through the requirements of GS1 compliance, what that means, and as a trust we need to implement

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with the people, product, place, GS1 piece, GS1 membership. We told them the costs of everything, because why would we hide it? It’s there. We talk to them about the fact that they need to have a PEPPOL access point, and point them in the direction of the many that are on the market. We don’t particularly care who they choose; choose one that you like or that suits your business model, and just let us know, and tell them the reasons why they need to do all of these things. And then we share with them the value of having a catalogue management provider and data that’s clear. Because it’s coming; it isn’t imminent, but we are going to have to have our suppliers put all of their data into a master data pool that’s specific for healthcare. Suppliers are gradually achieving compliance with GS1 and PEPPOL standards. Compliance with GS1 barcodes was also being integrated into RFP tenders, whereby companies were awarded 5 percent of the score if they were GS1-compliant. One global national company that supplied implants had 250,000 stock keeping units to transition to GS1 barcoding, which was a massive transition. At the time of this case research, 70 percent of suppliers are GS1-compatible with the larger suppliers that are already using GS1: We did a recent check, and if we just fix on the theatres … I’d say about 70 percent, ... we’ve then got issues with—it could be a GS1, but then they might have a secondary barcode that then has the batch and lot, so it’s a good percentage. Especially when we started three years ago when actually we were just starting out on this scanner, whether it’s GS1 or not, but now it’s getting better. Every country that gets awarded, you get new and richer data, which is mainly GS1-compliant. (Supply chain leader) Suppliers have significant complexity to overcome in order to successfully adopt GS1 standards for product identification. One of the issues is correct and accurate barcodes on every product, as described above. Trusts generally approached the supplier community and engaged in a variety of collaboration initiatives with them to support and accelerate adoption of global standards. One of the trusts described their approach: For our trust, we felt it was best that we didn’t manage the data, and we looked to have the suppliers manage the data. You clean it up. The resource time and effort and cost to do that is enormous, and I think that’s potentially why our suppliers are a little slow, because … their systems are just as shocking as ours. So the slowness of them getting to the party, or perhaps being at the party and taking some time to get to the next cocktail, seems to be that they’re cleaning up an awful lot of mess internally. And I think the other challenge that they have is they will have a barcode that’s compliant, potentially GS1, HIBC, or any other barcode, linear barcode, but the healthcare sector, as we’ve already said, [has] two points of view. We need to have that product attribute. They’ve never had to do that before; in retail, it’s never been a requirement.

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The second challenge is the multiple and varied requests from health organizations globally who request product attribute information to support patient safety (e.g., such attributes as “latex-free” or “single use”). When global suppliers provide product in many different countries, each with hundreds of organizations that require different sets of product attributes, that makes it very complex in order to ensure every individual product has correct and accurate information: The idea behind [GS1 standards adoption] is that through the GDSN, you would actually enter the data once. And it would be in somewhere like the UK, or somewhere like England, there would be a national data pool that would receive all that information. So, one of the challenges that suppliers have is these guys here will say, “Oh, we’re running a tender, please supply 47 different attributes.” This guy over here running the exact same tender has 56 attributes, of which only five will be [the same], and actually, when you start up with a list of data attributes, … this is what the NHS likes. (Supply chain leader) The adoption of GS1 and PEPPOL standards not only requires the supplier community to provide accurate barcodes and product attributes; it also requires information systems in the trusts to be able to accept and upload product barcode information into the hospital information systems: So that’s a start of what we need to do, and that’s basically what we’ve been working on over the last 18 months with our system—just updating our system to the GS1 piece. And that is really easy, just get your system to hold a GS1 key. You would think it would be. I’m not a developer, so when we asked them to do that [we] thought, “Well, there’s a 10-minute job.” … The spec kind of grows, grows, grows until you understand what you actually want do with these keys, and that turns the development from being a two- or three-week development to a longer period. So, one thing we did do is underestimate how much work was needed just to get your system to be GS1-compliant. (Supply chain leader) The supplier community is making progress. However, the ability to support scanning barcodes at the point of care for patients remains a challenge for some products. The suppliers have been able to accurately label products at the “box level,” but are still working towards accurate product labelling at the “unit level”: That element is in the suppliers’ hands. And we’re trying to get them on that journey and to join us. They’re pretty good at box level, but when we get down to unit levels, it’s a big challenge. And I think we’ll get there … [by] 2020 maybe …because it’s slow progress for the suppliers. The GTIN is owned by the manufacturer, so we have no input into that. … The manufacturer creates the GTIN, and there’s a different GTIN at each level. So a box of syringes [has] GTINs, and that’s where we’re struggling at the moment, is that we can quite easily get GTINs at box level, but we don’t consume a box of syringes, we consume individual. So what we call the unit of use level, that’s our challenge to get our suppliers to GTIN at that level. If we look at our supplies at the moment, we’ll probably find

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we’ve got a high proportion and a high percentage of them saying, “Yeah, I can GTIN at box level or at case level.” Great. The unit level is more challenging. And we’re just going to have to drive along our journey. It’ll gather momentum when we get more … information, because that’s the GTIN we scan at point of care. (Supply chain leader) The realization and slow pace of suppliers being able to provide products with global standard barcodes and product attributes resulted in a variety of strategies among trust sites in managing these challenges. One team organized several events for suppliers to provide information, educate and build awareness among the supplier community: They ask for advice and some help, and we share. We all share best practices and information and presentation material. There’s no point in reinventing the wheel, and we say, “This is what works; use whatever you think is right for your local suppliers.” And sometimes you have to adapt and tailor your communication to the audience, because you might have the guys that know what they’re doing, but they want to know what [trust name] are doing and tailor it to that. But then you’ve got a small or medium enterprise that hasn’t got a clue, and he’s terrified to death he’s going to go out of business now, because all of this is going to put him out of business. (Supply chain leader) Another trust started with identifying the product attributes needed, and then approached a supplier association for feedback: They came with a starting point, which is when they got the 93 or 92 [product attributes], and then took them to the trade associations, and so [got] lots … of feedback [from suppliers]. And there was some really interesting stuff, and the first thing was, “No, we can’t do that,” and then it’s, “Well, actually look, this is what we’re trying to do,” and then it started to make sense and then, “It’s okay, let’s see what this looks like.” And in fairness, that noise has gone away. (Supply chain team leader) Another trust approached large global companies to build collaborative partnerships to support progress in standards adoption: One of the [leaders] from [global company name] flew over from Newark, and they’ve got a facility out in [community name], a beautiful place. We went out there and looked at this facility, and they had seven different production facilities and distribution. Everything ranging from a system based on 1970s Cobalt programming to something that was state of the art, 21st-century radiation, in terms of sterilization. And each one of those has to be changed to get the barcodes. So … we came over and said, “Look, we need some advice, what should we do first?” So, we went for the high volume, high cost… Starting there, they were just so receptive to what we were doing. They wanted barcoding in the theatre. Partnerships were also developed with management providers as a strategy to create a large platform for suppliers to upload and clean their data. This platform can connect to the trust’s catalogue provider with hopes of going “live” in the fall of 2017:

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We established a partnership with a couple of inventory management providers that has a live platform for them to load their data, and they can clean the data in this platform, which is something that they’re finding quite transformational. They can load their data in as it is now, which is rubbish, so it’s rubbish in, rubbish out currently. They’re not doing anything they haven’t done previously, and they go in and dump in all the rubbish and then it takes less time for them to clean it all up. The platform that we’ve chosen is an agile disruptive software solution and it doesn’t matter how they put their data in; they just map it to the way it is in the platform, and it sorts all the data out. And then they go in at a later point and start to refresh and update as the GTINs are getting to the level that we require, and they can change their data in real time. We have already tried and tested our connectivity. We are connected to our catalogue provider. The trusts are able to access the presented files. We haven’t; we will be going live scheduled for September, towards the end of September, they think. And it’s not because the catalogue solution is not ready, or the trust is not ready—it’s purely down to the fact that the suppliers need to clean up their act, really. Our supplier onboarding program, [trust name], have been quite aggressively in the lead with supplier adoption. (Supply chain leader) Another demonstrator trust described their effort to work with almost 900 suppliers, engaging them and supporting their work towards adoption of GS1 standards and PEPPOL. Currently, 50 suppliers are ready to implement PEPPOL for this particular trust, which is entering the final phase of testing. The supply chain team held large events to talk to suppliers about the Department of Health mandate, GS1 compliance, PEPPOL and the need for product data: Almost 900 suppliers that we have engaged with—some of those are shared suppliers with other trusts, and some are regional suppliers to the northeast, and some aren’t even suppliers to the NHS, but are working potentially around NHS supply chain in the hopes of maybe potentially putting on contracts. We’ve had a big mix. Our system is ready; we’re just about to enter into our final round of PEPPOL testing this week, as it happens. So, by next week, we should be, in theory, able to flick that switch to say we’re fully ready now, with all our GS1 components within the system and PEPPOL live with a live supplier. So, by this time next week, I hope to say we’ve got suppliers with whom we’re trading POs, invoices, credit notes, and it’s just a case or wrapping that up. We’ve got 50 suppliers already on our list saying they are ready and waiting, can we just onboard them. So that’s what we’ll do. We’ll do the one, make sure it works. (Supply chain leader) Supply chain staff have engaged suppliers directly to get the correct data and product attributes: It was no use just waiting, because we were asking suppliers, and I had my data team writing to suppliers and saying, “When you provide any product data, can you supply your GTINs as well?” But that was very, very slow coming in, and that was why I was like, “We can’t hang about and

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wait for this, we need to get physically on the ground.” (Supply chain leader) The catalogue management prescribed-use case required the structuring of master data attributes and coding of products to enable the tracking and tracing of medical devices, pharmaceuticals and clinician treatments linked to patients. At the time of this casebased research, the majority of the NHS trust demonstrator sites continue to work with suppliers to fully adopt the GS1 and PEPPOL standards to support catalogue management and automation of recall processes that track and trace products and care processes to patient identification.

Automating Inventory Management Processes to Reduce Waste Prior to implementation of GS1 and PEPPOL standards, inventory was managed manually in many of these trusts with no automated system to identify what products were in inventory, where the products were located and no record of which products were used in care for patients. A supply chain leader describes the realization of the value of accurate inventory practices achieved in clinical settings: What we did have was finance managers sending a ward or department a list of things to count for stock’s sake, and now you either count everything or nothing. You don’t just do those eight things, or you know, that certain percentage. That’s just ludicrous. So, I gave them examples. In our neonatal ICU, they were showing something like £8,000 worth of stock. I got one of my guys to go in there and count it all. We have £42,000. So, we needed to do a full stock take of what we’ve got, and then start counting it properly and recording it. To date, there have been only limited tools or practices to determine whether the right products are being purchased for clinical care. Supply chain staff describe the progress of inventory management and the opportunity it offers for proactive, evidence-informed decisions: We have no intelligence behind our buying decision other than our tender exercise, which says we bought it because it came in with cost, but quality, etc.— it actually isn’t the right product. It isn’t delivering the right outcome. And we are behind because retail have been [using this system] for a long, long time. And they use that intelligence now to know what to buy and in what volumes, and depending on the weather, and so on. We should get to that. And yeah, it’s winter. … We know we have more breaks, more fractures, but actually, is our system intelligent enough to start pre-ordering … rather than [being] reactive? Can we get to a proactive decision? Yes, we can. The automation of inventory management captures the movement of products across the entire organization. When products are delivered, they are scanned and placed into inventory. The scanning allows supply chain leaders to see the full journey of the items,

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as well as what exactly is in the stockroom. It gives the supply chain team the data to mitigate waste from expired products, product recall and managing waste by tracking every product in inventory: We’re live, and what we also do in cardiac catheterization labs is we receive stock into the storeroom. So, when it gets delivered we also scan it and pop it away … . That’s really important, because that gives you … the full journey. … Not only are you scanning it at the point of use, you also know exactly what’s in your stockroom, which is essential, because that’s how you get your expiry, waste, product recall. We can quickly go to that shelf to pull it off as well. (Supply chain leader) Besides products, equipment is also tracked in inventory, so that the location of every equipment item is known and easily accessible: Just figuring out where some of these locked cupboards are that hold a lot of the machines [is helpful]. … And you know how nobody ever really shares the real savings; they’ve admitted to us that they’ve actually reduced their inventory by 40 percent. (Supply chain leader) As the Scan4Safety teams began to introduce the catalogue management enabler, a change in relationship with clinicians, and a change in how inventory products are linked to utilization during care processes, were two key areas of work required to implement this core enabler: When we first started, we would say to them, “Okay, so what products do you want to hold in your theatre, and what levels? We’ll need a stock take.” It didn’t even match what they said, so they’d have the same thing in different places within that theatre. So, it’s about getting all of that sorted out. If they said, “We need to hold five [pairs of size] small gloves,” we go and say, “Okay, we’ll start with 50.” And then after three months, we say, “Actually, you guys only need to hold 10. And then we’ll replenish you on a daily basis.” So the other thing is, [clinicians] don’t come into the storerooms any more, either. We feed it to them, so it’s changed the whole way we work. (Supply chain leader) Once this core enabler is introduced, there is much greater automation relative to digital tracking which supplies or products are used, and which inventory levels require replenishment, based on an established set of criteria that determine when and how often products are replenished: All we do is just run a report, and it will say, “These guys have gone below on this,” and it’s fallen below. So, for instance, if their stock level is 10, and they fall below the level of five, then we replenish it. We wouldn’t necessarily replenish one on one; it depends on what the product is and the location. We can set that individually, because it wouldn’t be efficient if each time somebody used one suture, we sent another one down there. The challenge of the accuracy of supplier identification of products and accurate product attributes is important in patient care and inventory management. To date, suppliers

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have not been using a global standard to identify products to describe their attributes (i.e., lot number, serial number, product attribute information, such as “latex”) that are critical for both patient safety (e.g., allergies to product components) and to inventory management. Scanning and barcodes are being implemented throughout the hospital, but there is concern of an “industry of work scanning” and taking up clinical time scanning: All of our patient facilities will have the appropriate GS1 barcode or 2D matrix, whether it’s a bed space or not, and we will have started with the scanning of patient to environment. Equally … we will have the Scan4Safety through all our different theatres. We are scanning products to patients, and we’re particularly concentrating on the implantable products to patients. … We don’t think there’s any value at all in scanning everything, because that would just create an industry of work scanning. And so, we don’t, certainly on the ward basis. We don’t want our nurses to be spending ages and ages scanning everything. (Clinician leader, NHS trust) A consistent finding across the four (of six) trusts engaged in this case study demonstrated a key outcome of the Scan4Safety enablers: the emergence of proactive, data-driven inventory management to ensure that the right products are available for care for patients when and where care is delivered. Waste reduction was a key outcome as well as proactivity, and optimized inventory replenishment based in clinical utilization of products. As the catalogue management prescribed-use case was achieved by the demonstrator sites, automation of processes also emerged, as described in the following section.

Automation: “Purchase-to-Pay”—“We All Talk the Same Language” “Purchase-to-pay” involves the automation and digitization of ordering and invoicing for goods and services using PEPPOL standards. PEPPOL is a set of technical specifications that are implemented in existing eProcurement programs to exchange information between two different systems (16). PEPPOL creates a standardized transaction strategy across all trusts: PEPPOL is more around standard format, a standardized format of transacting. So, you know, if you order a dress online … and you pick the dress via the GTIN, you pick the size, and then you put your house address and that is the standard format. That’s pretty much standardized transaction online anywhere. So, instead, what currently happens in the trust is that somebody orders a product, might use a product code, might use a GTIN … . (Supply chain leader) PEPPOL provides interoperability for the exchange of eOrders, shipping notices, invoices, catalogues and messaging, while connecting users with a set of standardized electronic documents (16). PEPPOL creates a single eProcurement link to suppliers

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and trusts, removing the need for multiple electronic data interchange (EDI) networks (16). Because PEPPOL can work with different supply chain technologies, it does not need the trust or supplier to change their systems (16). The Pan-European Product Public Procurement Online is an access point that creates a common language between NHS trusts and the supplier community. Once suppliers became PEPPOL-compliant, they can engage and conduct digital transactions with all NHS organizations without the need to secure multiple interface systems. The trusts send their information to an access point provider, which converts it into a PEPPOLcompliant message and allows communication with the supplier. This communication provides a response, so that supply chain teams in each trust can be informed when orders have been processed and plan for deliveries: It’s very complex, but the essence is we all talk the same language. So, from our supplier point of view, once they become PEPPOL-compliant, they’ve got access to all the NHS. Straightaway. One solution. One cost. So, it’s literally stripping a lot of cost for them, because … if they want to do EDI and it’s 154 trusts, they could potentially have to have 154 different interfaces, and it’s a cost to manage and maintain each one of them. And the way that works is just simply by having an all-access point provider. So, the trust has an access point provider, and the supplier has an access point provider. We talk to our access point, we send our information to our AP; they convert that into a PEPPOL-compliant message, and they send that to the supplier’s PEPPOL access point, who then picks up that message and then sends it to the back office. And they’ll take it when it gets to the supplier side, because they’ll want to change the ERP [Enterprise Resource Planning]—they pick it, push it in, [it’s a digital] interaction, end to end, without any human intervention. And what we are doing through PEPPOL is, we’re sending POs, getting invoices back, credit notes in the margin. And what we realized, originally—we weren’t doing order responses; that wasn’t part of our mandate. We were just doing PO, invoice and credit. And then we realized fairly early on, would it be really helpful to know if that supplier got our order? So, we get an order response which tells us that they’ve got the order, they’re now going to process it, and it will be filled, or they can’t fulfill it for whatever reason. And there’s an additional order response which is going to tell us that it goes through a full EDI system, which is really useful for us because we couldn’t re-send a PEPPOL-compliant message to the supplier. And if they’re small, if they aren’t integrated, they might still just pull that compliant message and manually input it. The automation of purchase-to-pay processes informs and strengthens inventory management in NHS trusts: I want to know they got it, processed it, and they’re going to deliver everything I asked for so I can plan for that delivery coming in. I know tomorrow I’m getting my implants, and everything I asked for in that order

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is going to arrive. They even know the batch number, lot and the expiry. Brilliant. I want to know that. (Supply chain leader) The movement towards PEPPOL has been difficult, with significant learning curves. As the trusts and suppliers started “from scratch,” the process has been refined and adjusted to better fit purchasing messaging. This includes the need for a data dictionary, one with which all messages must comply for specification of meaning and little need for individual interpretation: They’ve come out with what’s called a data dictionary, and all of your messages must comply with that. And if it doesn’t comply with that, you are not compliant. So, we tailored the specification and narrowed it down to, “Every message coming out of a trust will [follow] this standard alone, this specification.” Therefore, it makes it easy for the suppliers to interpret, because [it entails] one standard rather than potentially 154. Which is good. So, we’ve learned that. (Supply chain leader) The European PEPPOL requirement has created a seamless digital system for tracking and tracing purchase orders (PO), invoicing, shipping notices and distribution of products from manufacturer to supply chain teams in each trust. This strategy essentially digitizes the flow of information and the logistics processes across the many steps in procuring products from suppliers through to delivery of the products to clinical units. This automation of purchase-to-pay processes is a key component of full traceability of products across the journey of care.

The “Perfect Order” One of the demonstrator sites described what they call a POP, or “perfect order.” Supply chain staff work with suppliers to understand what the perfect order looks like. In the supply chain industry, the “perfect order” is defined as “a purchase order processed electronically (from order to payment) without human intervention, which is delivered to the correct location, on time, undamaged, at the right price, with the desired quantity, on the first attempt” (17). Creating the perfect order is thought to save substantial time because currently, invoices and orders are checked manually. Many hospitals have no inventory management system, resulting in an inability to validate the presence or absence of ordered products. At present, there are many inefficacies in products not matching. The POP is a way to catch this at the beginning of the order instead of at the end: It’s not perfect now, and if we can get them to understand what a perfect order looks like and what it consist of, then we’ll take out one of the inefficiencies that we currently have in terms of downstream. We deal a lot at the end where the invoice doesn’t match, or have I got the right goods? And that’s because we never got it right at the very, very beginning. So, we’re flipping our process to say rather than address it at the end, let’s get it right at the very beginning. What happens at the end is it just gets matched and it gets paid and it’s done. (Supply chain leader)

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Currently, 70 percent of invoices from this trust have a query being sorted manually by the accounting staff. The integration of PEPPOL standards is hoped to reduce the amount of errors in the accounts, with the goal of eventually reaching zero by improving reporting information and reducing variation in product. It will answer the key questions: “What are we buying?” “Where are we buying it from?” and, “What are we paying?” Supply chain staff hope that ordering will become clearer and that it will be easier to understand what is being purchased in exact volumes, benchmarked against other suppliers for increased value. The products can be linked to a Care-Scan-Plus strategy that will identify which products are used for which patients, and where value can be found in choosing these products: At this moment … , our benchmark is our [accounts payable] departments, which have to resolve 69 or 70 percent of our invoices. They end up having to resolve them because there’s a query on them. … What we’re hoping … is that we’ll get better reporting information, because at the moment, when it comes to GTINs, when we try to benchmark with other organizations—I’ll call it a pen, you might call it a writing implement. It’s the same product, but it’s down as three different items. It won’t compare because [the terminology is] not the same. The idea about the GTIN is that it’s a pen, it’s a writing implement, it’s all got the same GTIN, and it’s the same brand, the same model, the same colour. So, we can do a lot of comparisons, … we can start and compare with our neighbours to say, “Well, what are you buying? What are you paying?” They don’t know what they’re buying, where they’re buying it from, and in what volumes, when actually, we’re going to get to the point where [they] can’t say that anymore, because we’re going to know exactly what we’re buying, and in what volumes, and what we’re paying, and we’ll benchmark it based on the other. And then we can start working collaboratively; we can start thinking more jointly. We’ll get better value. (Supply chain leader) The purchase of consignment items remains a challenge that teams are looking to solve in the future. The difference in how suppliers manage consignment items makes it difficult for staff to find a solution: Consignment is on the “difficult” pile. … We are tasked as a working group to find a solution. We don’t have solutions yet as to how we’re going to recapture consignment. We are capturing consignment, but how to actually place an order for consignment, and make sure that lot batch has all gone through the system—that’s a bigger challenge for us, because some of our suppliers say they need it, some are saying they don’t. And what we need to do is engage with the market to understand what it is they’re wanting from us. But we need to put in a solution around consignment, so I haven’t got that answer for you yet. Come back to me in 12 months’ time. (Supply chain leader) Consignment products are typically brought into clinical settings by supplier sales staff, and are not registered or tracked in inventory. Consignment products are paid for only when the product is used during patient care. Hence, a strategy for scanning

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consignment products as they are brought into clinical settings, such as operating theatres, remains a challenge for many of the trusts.

Integration of Supply Chain into Clinical Practice and Clinician Workflow Clinician engagement is identified by many stakeholders as a key dimension of the Scan4Safety initiative. The data and real-time nature of point of care scanning enables new insights and tracking of care processes for individual patients and the providers who deliver care, often in highly specialized settings such as surgical theatres. The importance of engaging clinicians, and the value that Scan4Safety offers clinician decisions, is described eloquently by one clinical leader: How do we get clinical engagement? Well … it was a real culture change that we had to bring about. The first thing we identified, is we would start with a compliant area. … We have a really compliant [surgical] group. They wanted this to work. And what’s more, we have a project team … that are real people, not virtual directors of performance, and they came down and they sold this message to us from the outset. … That’s a revolution in the NHS … .We sold it to them on the fact that we were looking at patient safety, we were looking at traceability, we were actually identifying how much income these surgeons were generating for the trust. ... What’s more, with things like joint registers, we can update external records quickly. In terms of where we are failing, things like comorbidity, what we are able to do now is record the comorbidity [and] so get the correct number of what we are doing. … If we have high death rates, it’s not surprising when we are treating complicated cases. (18) One of the key value propositions of the data that is collected at the point of care is described both in terms of bringing credible evidence to inform clinician decisions regarding patient safety and reducing variation: It’s all about incrementally attacking variation. The first thing, when you show a group of clinicians what the results are, they will say, “We don’t believe the information. We don’t believe the data.” You have to go, time and again, back to prove to clinicians that the data is good, if you are portioning data, or as we do in England, have reference costs, that are not granular or accurate. And clinicians will say, “We don’t believe you.” And you can’t blame them for saying that, because they are right. What the [GS1] barcoding project does, is it starts to build the argument. It doesn’t mean that all variation is wrong; it just starts to build the argument. (Clinician leader) Standardization of products used in specialty programs, such as surgeon preference trays—trays with personal product and instrument preferences—is an opportunity to determine the best products for safe patient outcomes, and is also emerging as an important cost savings opportunity for NHS trusts. One of the trusts is working with groups of speciality clinicians to reduce waste in surgical preference trays, due to

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products on surgical trays that are not used, and result in very costly waste. The reduction of products on surgical preference trays has resulted in significant savings: The other thing there is putting in much more attuned stock levels and much more reduced trays. … It’s a big job to go through all those things, but as soon as we get to the end, all that means is we go back to the beginning again, and just turn the screw a little bit more. Because we’ve already started looking at those … specialties [for which] we’ve already rationalized their trays, but they may have rationalized them to a point where there’s one or two instruments into the next level of charging to the tray. Well, if it means that by removing two instruments, we can reduce it much further, the challenge is having the physicians have a look. And in terms of procurement, … prior to Scan4Safety, things like rationalizing sutures, rationalizing carts, etc. … What this allows you to do, or will eventually allow you to do, is track it to the areas and specialities, and get it tighter and tighter and tighter. To give you an example of one operation in one area, cataracts—the tray reduction alone is a £30,000 per year saving. (Supply chain leader) The trusts are working towards reducing variation in surgeon preference trays in order to avoid purchasing individual instruments for each clinician: One is the re-sterilization cost, but the other is, … it’s in excess of 900 instruments that we pulled from trays, just in the areas we’ve done. We pull from trays that were able to be recycled into other trays to stop us having to buy 900 … instruments. Does that make sense? (Supply chain leader) Supply chain teams working with clinicians focus on the goal of reducing variability of products purchased, while ensuring clinicians are consulted in decisions on what products are best for each type of surgical case. The importance of clinician engagement in having input into decisions is a consistent theme across all the trusts. In one such strategy, [b]asically, a letter went out saying, “We need to change; we need to save this amount of money. This is the equivalent of six nurses per year, so I’m expecting you to use the perfect match. There’s a form. If you think it’s not right, you let us know, but this is a perfect match. I’m expecting you to use it. This area is no match at all; you can’t use it. It’s close, but if you’re happy with it, please use it. If not, tell us why.” And that’s how we changed. Nine hundred consultants—not all the surgeons, obviously, maybe half the surgeons. I think I got back two heated emails, as you can imagine. And we did it and I think there’s been very good reception. (Supply chain leader) In order to gain clinician support, one of the trusts focused efforts on streamlining clinician workflow when introducing scanning devices in surgical theatres. This particular team has reduced clinician time and effort by “hard wiring” the location of

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scanners in each surgical theatre: clinicians can simply enter the room and the scanning device is well positioned to scan products and patient identification bands. This strategy is designed to support a streamlined flow of work practices for clinician teams and improve efficiency: To save the clinician having to scan everything, if they walk out of that room and go to the next one, they know to scan the room, so they know the process of that, and to make sure that stays. But because the charging device and everything stays in the theatre as well, there’s no reason for that to leave that theatre unless there’s an alignment problem with it, which is very rare, and if that’s the case one of the guys actually goes down and fixes it. … We’ve gone through that kind of iteration of, “Hi, this is a new scanner. We want you to do all this new work, the new scanner and we need to scan everything.” And [they reply], “You’re kidding me. That’s going to slow me down; that’s putting my patient at risk.” We’re reaching that point now where it works well for the clinicians and works well for us and they actually have that data. … We’ve gone through three years now with real fine-tuning … just to make sure it’s efficient and the quality output is of the standard we need it to be. (Supply chain leader) The relationship between clinicians and supply chain teams has also shifted with the implementation of the Scan4Safety program. Communication between supply chain team members and clinicians has shifted from email and phone communication to faceto-face meetings, which build relationships and support in-person communication as a strategy to further engage clinicians in the goals of the Scan4Safety program: We go and speak with the [clinicians] quite a lot. … When I first came in years ago, we’d sit in procurement and not go down. … And maybe occasionally you’d speak on the phone, but normally email, because it’s safer. But now, we get clinicians that come and sit next to us and they know who we are. We can go down and see them, and feel comfortable, pop into scrubs if we have to, and it just becomes a different skill set then, which we all actually understand. … And they do also find and understand that they can make a difference financially. (Supply chain leader) A hallmark feature of the Scan4Safety program was related to the importance and value of clinician engagement in working with supply chain teams to examine variation, consider product utilization to reduce waste and leverage data to consider safety outcomes and value for patients. As healthcare budgets have become tighter, more “cost awareness” has driven the NHS strategy. Supply chain staff emphasize to clinicians that they must be more aware about how much and what specific equipment is used in hospitals to reflect pricing of medical equipment: We have seen costs coming down, because there’s … lots of initiatives in NHS to do that, but we know this is part of it. But I wouldn’t want to say it’s all because of this. … We have all three different [pairs of] gloves: the [surgical] gloves, the domestic gloves, and then the procedure gloves. So, we range from 20 pence all the way through to … £2 for a surgeon’s glove. … And we try to educate staff: … “If you’ve [just] got spillage, please don’t take a surgeon’s glove.” (Supply chain leader)

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Another strategy that supply chain teams have used to build awareness among clinicians of cost and value was to identify individual product prices on each item in the supply room. In one demonstrator site, an inventory management system used bins that were labelled with the name of the product and the product price. This strategy was designed to inform staff of the cost of products so that clinicians could make decisions to use products based on both patient need and product cost to achieve value. In specialty settings, inventory staff manages the inventory daily, monitoring consumables stock Monday through Friday to ensure that stock is present. All orders to replenish stock are scanned and barcoded to automatically generate the order and invoice for the product by GLN, to identify exact location. Products are tracked only in high-cost units— the system is currently rolling out in surgical theatres and is already in place in cardiac catheterization units in some of the demonstrator site settings. Supply chain leaders believe the scanning helps curb costs as it shows the cost of items to clinicians, so they can decide whether certain equipment is needed or whether a cheaper item works. Scanning also enables the flow of data linking product data in inventory systems to patient data in clinical records, describing which products are used for which patients. The data is then linked to outcomes to determine the procedures or care processes that work best for particular groups of patients: Not only have we got that evidence, but we can also say, ultimately, “What was the outcome with the patient? Was it successful? Did it need more interventions? Was there a greater cost?” So, we can say, “We’ve taken an approach of using this product. … Overall, we find that there’s less waste with this. We find that it might cost less, but overall, we might find that the outcomes for the patient are better because of this.” Engaging clinicians is a key strategy to support change management to fully integrate scanning into clinical practice routines. Training was an important strategy used by the trusts to support clinician teams in learning to integrate the scanning processes into their clinical workflow. In addition to training, supply chain team members were assigned to clinical units to support clinicians as they learned to use the scanning devices during patient care: The other thing that we’ve been doing as well is … we had a massive training plan. We couldn’t just go in there and say, “There you go, off you go,” so we had to train. We give out little pocket guides. … It took us about a year, a year and a half. (Supply chain leader) A key objective of the training was educating staff on the link between scanning products and care processes and improved patient outcomes: Generally, once it was explained [that] it’s there for them, to protect [clinicians], … to improve … the patient experience, … they’re almost saying, “Okay, when can we do it? When can we have it?” …We’ve got the clinical teams’ support on site, that’s in theatres. We’ve had a member of staff in the theatre for every list, every orthopaedic list, every surgical list. (Supply chain leader)

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Placing a supply chain team member in the surgical theatre was an important strategy to support clinicians to integrate scanning into their clinical practice workflow: We need to support the [clinical] staff, and we’ll come to you to do that. … We also started to look at our wards as well. We actually started to get on two wards; we took a surgical ward and we took a medical ward. And we took the view that [we would] start very small, and not scan absolutely every single item. … So, on the surgical ward, we chose high-risk things like catheters, just to get an idea, and just to get them started. We had to do lots of work with them on the wards, because they didn’t know what products they were going to scan, and so we had to place labels. We also had done some pre and post. We’ve done orders with patients as well, pre and post, in those areas to see how they felt about it. (Supply chain leader) A hallmark of successful clinician engagement in the participating trusts included four key strategies. The first is informing and working with clinician teams to understand the relevance of supply chain traceability to informing clinician decisions and patient care. The second is empowering clinicians to make decisions on product procurement and product standardization, fuelled and informed by objective supply chain data that identifies what products are used by which clinicians to achieve the most optimal outcomes for patients. The third is the shift towards relationship building between supply chain teams and clinician teams to collaborate and work together to achieve quality patient care and program savings, informed by objective utilization data and patient outcomes, captured by scanning products, patients, providers and locations of care. Finally, there is emerging evidence that clinicians and supply chain teams work together to reduce clinical variation, informed by inventory and utilization data, to support safe and high-quality patient care. Clinician team and supply chain team collaboration requires focus and attention towards relationship building and working together to achieve priority goals and outcomes in these demonstrator site trusts.

Creating the “Single Source of Truth” One of the key strategies of the Scan4Safety program is described by Secretary Hunt as creating the world’s largest learning organization, one that documents the complete journey of patient care to measure quality outcomes for patients. In order to document patient care across the continuum of care, patients carry unique identification based on global standards, storing and recording accurate information about the products, processes of care and outcomes, as documented in the patient’s medical record (9). To accurately identify patients, a GS1 barcoded wristband is placed on all patients when entering the hospital trust. The patient ID band is then scanned at all points throughout the patient journey (9). Events are recorded from patients’ arrival to the time when they exit the hospital, including observations, assessments and administration of any treatments (9). Patient scanning eliminates any hand-written records and is designed to increase accuracy of information in real time, while minimizing the risk of missing or inaccurate information about care the patient has received. Accurate patient identification is viewed as a critical enabler that provides visibility for clinician teams relative to documenting patient care across the entire journey of care, described by

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Secretary Hunt as the “single source of truth” (4). Using electronic health records, clinicians can readily see where their patients have been and what treatment they have received: The real plus from a clinical perspective—aside from the financial and the quality drivers, and the removal of waste in every shape or form—[is that I] want to know where my patient is 24/7, 365: where they’ve been, what they’ve had done, all of that, and by whom. … I want all of that information to be automatically uploaded onto their electronic discharge note. And we should be able to do that, and we can’t. (Clinician) This level of documentation and tracking of patient care is viewed as an opportunity to support clinician accountability: What we do, is everything is scanned, absolutely everything. The patient, the staff, I mean every [healthcare aide] that’s in theatre, we scan them. If the surgeon is not in theatre, he doesn’t get scanned. … I know how many lists he’s turned up for, how many cases he’s done, and so it makes my job a hell of a lot easier as a director. We are looking at all lone sets, and we are looking at the fine detail. And we are doing it because we have staff that are prepared to use a relatively simple technique to get information. (18) The Scan4Safety initiative identifies patients, tracks the care processes patients receive, and tracks and traces the products used in care for each individual patient. However, as clinicians describe the applications of this detailed and robust data emerging from point of care scanning, important applications for this data are emerging. This excerpt suggests that provider accountabilities are an application that is important for clinician leaders to track quality of care delivery at the individual clinician level, as well as utilization of products in care, which can inform decisions on product procurement and standardization of inventory to reduce costs. The scanning technology creates the flow of data, which links product information and attributes from inventory data to patient care records to document the patient’s journey. Currently, supply chain staff are working on acquiring product attribute data from suppliers, to inform clinician decisions and assess quality of care outcomes, in order to determine which products offer the safest outcomes for patients. However, the application of this scanning infrastructure encompasses more than just products used at the point of care: Scanning information at the point of care with the patient … doesn’t have to be clinical contact people only that use the system, because a porter who is moving a wheelchair from store to a bay can evidence that tracking. And a person in the storeroom can also collect data that shows the arrival of the subsequent transfer of products through the organization. That transfer might also include clinical sterilization areas, so you can collect the information anywhere. (Supply chain leader)

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If there is an issue or recall, this information is easily accessed and evaluated relative to patient safety, patterns of adverse events and further clinical data required to assess how best to prevent risk of harm to patients: What we do then is—around the ward, on the nurses’ station or whatever—we say, “This is where the adverse event occurred. I’ve got the context of the patient, I know the staff, I’ll scan that code and thereafter it prompts them to collect the information, the data required.” But it already puts a time stamp down because every one of those transactions has a time stamp … . So, what we do then is, we’ve got the association and the ability to start pulling out reports, and where there are some that are prefilled and some things are collected. So straight away we’ve got the whole picture. (Supply chain leader) The comprehensive flow of data—from product to inventory to patient care outcomes— creates the data infrastructure that is foundational to quality and safety initiatives to identify the products and care processes that offer the best outcomes for specific subpopulations of patients. The use of global standards for barcodes allows clinical organizations to document the patient journey and evaluate the effectiveness of care delivery for every individual patient: I had to look at some of the letters that we sent out a few years ago, and there [were] about seven barcodes on the letters [that were] not GS1compliant—actually, none of the barcodes made any sense. Nobody knew what they were; they were just a random barcode. There was maybe some kind of barcode, and you just think, “Why are we even doing that?” when actually there’s a much cleverer way of saying, “Let’s just have a GS1-compliant 2D data matrix on there. If somebody comes in, scans it, they’ve arrived.” And then think about all the information you can start to use in terms of patient pathway, waiting times, bottlenecks. (Supply chain leader) One of the trusts, described as being very advanced in supply chain infrastructure, has now leveraged the scanning infrastructure in clinical units to examine and strengthen the internal supply chain processes across the organization. The trust has set up a working group to ensure that all of the clinical programs are utilizing the same field of data and data capture at point of use. This creates a standardized data infrastructure in all clinical settings generating data that can be applied to all support services departments across the organization: This [group] is almost a workgroup that we’ve set up, which is basically point of use, just to make sure that all hospitals are utilizing the same field of data for data capture. So, if I am a nurse, I’m about to fit a tracheostomy. It’s just, “Okay, well, how do you capture doing that? What’s it called? What does it look like? Do respiratory therapists call it the same thing? Are we capturing the same sets of data?” … In endoscopy, we’ve been a trial for quite a while. We’ll have probably a chat some point today, just about what that looks like, just in terms of going into endoscopy. Is it what we’ve been doing in theatres? (Supply chain leader)

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Clinical programs use the collected data to determine treatment plans for patients with comorbidities. A collection of specialized barcodes offers a mapping of the treatment plan and patient diagnoses to achieve a standardized medical record of diagnostic terms, procedure codes and clinical pathways that clinicians scan, which reflect the diagnoses, comorbidities or health challenges each patient is experiencing. This standardized “codebook” of patient care allows for a treatment plan to be created for patients with multiple morbidities, reducing the variation in treatment and care procedures, thus offering greater quality of care, and standardized pathways to care, to mitigate both clinical and financial risk: But if you take that at a national level … you’re collecting the appropriate data and you say, “You know, someone with COPD or somebody is on dialysis … we should have a treatment plan for the typical patient.” And then, wherever you are in the country, this is what happens, unless there’s a good reason … . So that just ends the [variation]. That same patient could be treated seven different ways. … And from a system perspective, we’re reducing variation and reducing clinical and financial risk. (Supply chain leader) In the majority of the Scan4Safety trusts, point of care scanning solutions and inventory management systems have been first implemented in the surgical theatres and cardiac catheterization units. In each theatre, there is a scanning device that can scan an OPCS code—an NHS clinical procedure code that captures medical decisions and procedures, and shows up in the patient’s medical record: This is the [scanning] solution that we use in our theatres. … It’s mainly kind of a point of care scanning solution, but also it does inventory management. So, this is the kind of data it captures. In every one of our theatres, we have one of these devices; it’s the first thing to point out. What we’ll do is … we scan the patient’s wristband. That wristband is GS1-compliant, whether it’s adult or neonatal. We are exploring what we do with people that walk in off the street for outpatient appointments. … You’ve probably got an electronic boarding card now; so actually, why can’t we do that with our patients? (Supply chain leader) Everything in this particular trust is scanned—pharmaceuticals, products used, procedures and clinicians: Anaesthetic, knife-to-skin, all that stuff is captured by the scanner. Location, GLN … everything is barcoded. (Supply chain leader) At the time of the study, each of the trusts had made progress in advancing point of care scanning across a wide range of clinical settings throughout the organization. All trusts had a common vision of the value and opportunity to document the patient’s journey of care using point of care scanning technology to link product data, patient identity, processes of care all linked to patient outcomes.

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Variability in Demonstrator Sites: Progress from Different Starting Points Each of the demonstrator sites had unique motivation to pursue Scan4Safety and varying degrees of progress towards advancing supply chain infrastructure at the time the Scan4Safety program had commenced. For example, one of the demonstrator trusts had begun their supply chain work in 2000, and had received a number of awards for inventory management practices. This particular site had been investing in supply chain management since that time, as the CEO had a clear vision for the value that supply chain transformation could achieve. The CEO’s strategy was to bring in experts in supply chain from the manufacturing sector to lead the transformation. One expert began to create the software to automate and digitize inventory processes, only to find there was no availability of product data that would enable inventory tracking: The Scan4Safety project first started last January, 18 months ago. It actually started for us 10 years ago, and to get to where we are now, it’s not been an 18-month journey. … The building blocks, storage—these are just the basics. Then you need all the data. … Yes, then move on to the high-volume products, get those on. Back in 2000, we were doing it in the catheterization labs. … We were using the barcode on the product, and you know, sometimes it works, and sometimes it never scanned. There was no standard, nothing GS1-wise, and what we thought when we first went into the cath labs and we got the barcodes working, we thought we could change the world. We thought we could get [Johnson & Johnson] and Medtronic and all these people, that they would change everything for us. (Supply chain leader) At this particular demonstration site, many advances in supply chain management have been achieved, including a repository for all product GTINs and attributes. The software refreshes all product information and attributes frequently to ensure that it is current and up to date, which accounts for updated product information from all suppliers that supply products to the trust. This highly experienced team also maintains a dashboard to monitor progress on key performance indicators, including supply cost per case, compliance rates among suppliers, product use and patient encounters, as well as order tracking, which includes vendor, product GTIN, GLN, invoice amount, payment status, transaction dates and discrepancy reporting. Orders and invoice slips are automated between the trust and all suppliers: This is a repository of all suppliers. We can click on some of those and then you’d be able to look at the GTINs associated and all the different attributes associated with products. … This is our catalogue. So, we’ve got the repository. You’re able to take all the attributes and populate your catalogue with those and refresh them. This needs refreshing, so we’ve got new product codes, and you’re able to refresh those and bring them in to the catalogue. … We have one catalogue per supplier, we can have many contracts, so we could be buying from local, regional, national contracts, and each one of those links in to that catalogue. You can only have one catalogue item; you can switch them. (Supply chain leader)

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The variation in starting points at each of the demonstrator trusts has resulted in different rates of progress across the demonstrator sites. Typical of most health systems, some organizations have evolved or progressed at different rates than others: There’s a nice learning to that story: … They’ve probably got one of the greatest returns on investments for GS1, but there was a point to be made. And the thing that we found is the Scan4Safety bit, I mean, [trust name] was so far ahead already, so it was retrofitting here. But where we’ve been able to look at the future, and where the real value of the standards comes from, has only been apparent in the last … six to nine months. In contrast, another demonstrator site was starting implementation of the Scan4Safety program from an entirely different starting point, whereby all supply chain processes were paper-based, and largely manual. At this demonstrator site, all orders were processed using PDF files sent to suppliers by email, and essentially all inventory processes—such as invoices and purchase orders—were paper-based when the Scan4Safety project began. A leader at this demonstrator site describes their motivation for pursuing this initiative: Once the system goes live [in a few weeks], analytics for product use and inventory demand will be built into the strategy, so products will be ordered on demand, not ordered by multiple units based on perceived need. We will be able to answer three key questions: What are we buying? Where are we buying from? and What are we paying? This demonstrator trust is working towards putting GLN barcodes in every room throughout the hospital, including bathrooms: All of GLN data is now loaded into our systems, so that becomes our key identifier. We did identify our products before, but it was just an internal key that we used; there was no consistency to it. Now we’ve got a GLN and a GS1 key, [meaning] we’re all talking about the same area with the same number, with the same description. Whereas before, [what] we might have called Ward 1, they might have called Ward 2, so there was never any consistency when we looked at all of our information on our system. Now we all call it the same thing, by the same word. Identifying locations enables greater efficiency for teams who know the exact locations for servicing equipment, delivering inventory or even locating patients as they undergo care procedures in different clinical settings across the trust. At the time of the data collection, point of care scanning was implemented for all implants, defined as any device implanted into patients for a minimum of 30 days: We just need to get to that level of data first. But we’re doing it on limited products, so we’re looking at clustering medical devices. Basically, it’s all products that [are implanted] in a patient for a minimum of 30 days. That’s what we’re going to look at scanning at the moment. (Supply chain team member)

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The progress of implementation varies depending on the starting point of the organization’s infrastructure, such as adoption of GS1 standards or automation of inventory management. The majority of the demonstrator trusts implemented point of care scanning in high-cost (i.e., high inventory cost) and high-risk clinical settings, such as surgical theatres, cardiac catheterization labs, diagnostic imaging and interventional radiology. Once these programs were implemented, trusts scaled to other clinical settings, such as the patient wards: [We] started to do some work in theatres. … It took us a year to get to this point; we’ve got procedures identified in all of our theatres on both sites. However, we’re in all our theatres. We’re not physically in the theatres on this site yet, even though we’ve got some procedures identified; we are scanning all implantables in that theatre. So, hips, knees, breast implants—we do patches for hernia repair ... . (Supply chain leader) Despite the different starting points among each of the trusts, the real value of global standards adoption emerged in the second year of implementation of the Scan4Safety program. As each trust fully implemented the three enablers, and then demonstrated the prescribed-use cases, the inventory savings emerged, the tracking and traceability identified potential risk to patients (e.g., recalled products) and the potential for waste reduction was demonstrated. There were many outcomes emerging across the three demonstrator sites that took part in this study, described in the following section.

Scan4Safety Outcomes and Impact: Return on Investment The Department of Health (DH) invested £12 million for the implementation of the Scan4Safety program in six demonstrator sites between January 2016 and March 2018. At the time of this case study data, DH leaders had determined the investment was yielding a 4:1 return, described as a “conservative” projection for the six sites. Based on financial savings to date, the DH is projecting a financial savings of £1,034,000 over seven years as the Scan4Safety program is implemented across the NHS (19). As each trust completed the milestones for each phase of the Scan4Safety program, onsite evaluation and demonstration of milestones were completed by a team of reviewers, to validate the results and impact of the program in each trust. Despite the fact that each trust began the program from very different starting points, savings and value were evident in each of the demonstrator sites. The Scan4Safety website identifies the following benefits and cost savings (20). Across the six demonstrator sites, the Scan4Safety program reports £741,000 of savings identified to date: • • •

Stock reduction/one off stock holiday—£233,000 Reduction in wastage/obsolescence—£462,000 Non-clinical pay efficiencies—£46,000

It is estimated that for a typical NHS hospital trust, the benefits potentially realized across the NHS are as follows:

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Time released to patient care—equivalent to 16 band 5 nurses per trust = 2,400 band 5 nurses across the NHS. A reduction of inventory averaging £1.5 million per trust = £216 million across the NHS. Ongoing operational efficiencies of £2.4 million per trust annually =£365 million across the NHS.

• •

Based on the benefits reported to date, if the Scan4Safety program were scaled across the NHS, an annual recurring savings of £365 million/year could be achieved. Based on the cost savings data reported to date, one can project the anticipated return on investment and financial benefits of the Scan4Safety program, if scaled across the entire NHS, based on current demonstrator site outcomes, as follows: • • • •

Cost of Implementation: £312,000,000 (£2,000,000 for 148 trusts; acute nonspecialist trusts and 17 acute trusts) Savings Benefits: £339,000,000 (£2.4 million per trust; annual savings due to operational efficiencies), yielding £28.5 million per month for the NHS One-Time Savings: £187,000,000 in savings due to inventory reduction Cumulative Benefits: £1,034,000,000 savings based on the 4:1 savings projected by the Department of Health, generated over a seven-year period.

Table 2 summarizes the benefits and financial impact of Scan4Safety to date, based on online presentations and case studies, as actual financial data was not available for the purpose of this study. Table 2. Benefits and savings reported for the Scan4Safety program Trust Inventory Labour Savings Savings 25 h/week Royal Cornwall Case outcomes £1 million Sources: (Sep. 2017)

- overstocking £93,000 - obsolete stock £61,000 - expired products

(clinician time saved released from inventory management tasks)


7 h/month - cardiac 4 h/month - orthopedics

(Nov. 2017) ntory-improvements-royal-cornwall-hospitals-trustprovide-improved-time-care-nurses-cost-savingefficiencies/

Other Reduced inventory from 7.5 wks stock levels to 2 wks Reduced consumables by 21% on medical ward

Salisbury Foundation Trust Sources: (Sep. 2017) 9/scan4safety-enables-product-patient-tracking.pdf

- 23% reduction in pharmacy stock (1 yr)

£57,000 - key support services

(Nov. 2017)

£120,069 areconference/2017/gs1_uk_hc_2017_breakout_d ay_1_nursing.pdf?la=en


Total Financial Benefit (Cumulative – end of Oct):£1,083,012 £311,622 – Benefit Type: One Off*

- ortho. implant stock reduction - theatres stock reduction

£39,000 - cardiology stock

2 FTE released - 1 estates - 1 finance Product recall <30 minutes

93% of implants are tracked to patients Standardization £121,000 - multiple depts. £88,000 - hips/knees £14,000

The Impact of Supply Chain Transformation |44 in the National Health Service, England . £869,621 – Benefit Reoccurring


- loan kit

£51,000 - expiry management, orthopedic

Derby Teaching Hospitals NHS Foundation Trust Source: Kevin Downs, Product safety recall – the view from the theatre at Derby Teaching Hospitals NHS Foundation Trust nts/marketingdocuments/gs1_uk_healthcare_the_vie w_from_the_theatre.pdf?la=en

The Leeds Teaching Hospitals NHS Trust Source: (Nov. 2017) nts/healthcareconference/2017/gs1_uk_2017_breakou t_day_2_scan4safety.pdf?la=en

£25,000 instrumentation

Non-stock spending reduced by 5%–7% £850,000 - coding of uncoded patients savings

£798,000 - efficiency savings (2015–16) £1,180,000 - efficiency savings (2016-17) £1,699,534 - inventory reduction

£84,411 - staff time for product recall

£94,064 - sterilization costs/yr (recurrent savings) £39,500 - one-time theatre tray rationalization £141,536 - returned stock £357,356 - reduced waste and obsolescence £133,564 - tray rationalization

Department of Health— England Source: GS1 Conference, November 2017 nts/healthcareconference/2017/gs1_uk_2017_breakou t_day_2_scan4safety.pdf?la=en

£2,416,401 Total benefits cost £6,000,000 - actual savings achieved to date £5,670,000 - forecasted savings £30,000,000 - monthly savings for NHS when fully implemented in 2022

The recurring nature of the savings due to operational efficiencies suggests an annualized savings, which offers impressive opportunity for system-level savings across the NHS. The 4:1 return on investment is described as “conservative” (personal

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communication, Steve Graham, eProcurement Lead, Department of Health). Trusts that were not part of the Scan4Safety program have initiated similar strategies of GS1 standards adoption, tracking and traceability of all products and providers, and linked to patient outcomes. One trust, Portsmouth, implemented GS1 standards and similar features of the Scan4Safety program and reported an 8.5:1 return on investment. The savings are generated immediately as point of care scanning is implemented, the majority of which become annualized due to reduction of waste. Thus, current evidence identified by the Department of Health and GS1 UK identify a substantial return on investment based on demonstrated cost and labour savings (“released time to care”) across the six demonstrator site trusts. Leaders in each of the four trusts participating in this part of the case study research described the many sources of additional cost savings and reduction of waste as a compelling outcome of the Scan4Safety program. These are profiled in the following section.

Cost Savings and Waste Reduction One of the key drivers of the eProcurement strategy at NHS was designed to create efficiencies in what was viewed as an expensive healthcare system. Adoption of global standards, catalogue management and identification of every patient, every product, and the location of care and provider teams delivering care created the infrastructure to generate accurate cost data that was simply not possible prior to the Scan4Safety initiative: So, you’ve got the cost of your facility, [and] the theatre costs £38 a minute per theatre. … If you compare clinical teams who are doing the same procedure, you might find that one is lowest on time and another is lowest on people. Another might be lowest on product. (NHS leader) Savings and cost reduction within the Scan4Safety strategy are viewed in terms of releasing clinician time to care for patients, which thereby opens up capacity within the system to deliver more care with the same level of funding: Now [much of] those savings are … around release of nursing time and doctor time; it’s not about looking to take money out. It’s about leaving the money in but being able to do more with the same amount of money. I think it [was] 2010 [when] they did a study and found that on average, nursing staff in the NHS were using one hour every shift and so, in a typical eight-hour shift, one hour [was lost] looking for stock. (Department of Health leader) Inventory waste has been a significant challenge for the NHS. It was estimated that the NHS has over £1.5 billion of inventory on the shelves, without an automated system to manage this significant asset effectively: We did a bit of work and we figured that out. … £1.5 billion-worth of inventory [is] a lot. If you were to halve that, you would probably still think it’s too much. So immediately, that’s £750 million benefit. (Supply chain leader)

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The cost savings reported by each of the trusts were due to recurring waste (e.g., expired product, or products opened and discarded) as well as informing staff of the cost of products: The waste element becomes important because they now think, “That’s been sitting on the shelf for a while. I know that they are 500 quid, they’re coming up to expiry date, let’s not just leave them on the shelf.” … We’re now getting people to understand. We put a lot of time and effort in, which is what we’re doing now. (Supply chain leader) Another trust spokesperson describes the cost savings emerging from stock reduction in moving from a manual to an automated system: It’s mostly stock reduction savings, because we had no way—unless you did a manual stock take—of knowing what stock we had … . We found that people were hoarding stock, so we suddenly got a lot of stock that’s out of date, and now when you scan it, it can’t be used. Also, in release of nursing time where they were placing orders for stock, they were doing stock checks, they were putting stock away, and a nurse shouldn’t be doing that. Nurses should be looking after patients. Many of the teams described the surprises that were not evident until this Scan4Safety infrastructure was introduced into clinical settings: I think when you start this journey, some of the surprises are, we didn’t even know [these problems] existed in this trust, and you’re probably finding in bigger hospitals than ours there’s lots of little systems that nobody ever comes across, and then until you deploy something like this, and they come out of the woodwork and you think, … “There’s another thing I have to think about.” The supply chain teams focused specifically on savings and areas of priority defined by the Department of Health: It then rolls down to justifying the purchase cost of these things, so we’ll concentrate in the areas that we know that the DH is targeting, the milestone return. In the meantime, we will always seek the best business opportunity we can to reduce the cost of these devices. So, if they came in at £600, why can’t we have them for £450 if we buy this volume? And what we want to do is embed [the cost] based upon success and hunger, so if somebody’s getting an advantage from it on the ward and they can see it, then we know we’ll get assistance through the adoption, and we’ll be able to. (Supply chain leader) One final cost savings potential was linked directly to patient safety, whereby improving patient outcomes and reducing adverse events may ultimately result in cost savings from litigation costs. However, there was no data to support this perception: We tend to forget [that improved outcomes] translate into dollars, into money, because our litigation costs, as we know, are in some difficulty,

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and if we used processes which could ensure medical errors happened less often, [the potential benefits are] obvious. (Clinician leader) Cost savings and waste reduction relative to inventory management in the demonstrator sites were an impressive outcome of the Scan4Safety program. There were many sources of cost savings identified by each one of the participating trusts. Savings were also evident in trusts that did not participate in the Scan4Safety program, as other trusts in the NHS had also begun to implement similar supply chain optimization strategies at the time of this research. Portsmouth Trust reported an 8.5:1 return on investment following the implementation of point of care scanning in surgical theatres (Figure 1). Figure 1. Inventory management, Portsmouth Hospitals NHS Trust Benefits of Inventory Management •

The return on investment was calculated as 8.5:1

Stock was reduced by 20%

Waste was reduced to less than 1%

Recalls were handled quickly and more efficiently

Inventory data was more accurate and visible across the whole trust

Source: GS1 UK case study, inventory management, Portsmouth Hospitals NHS Trust,

The cost savings across the demonstrator sites are impressive and have been a catalyst for many additional outcomes and areas of impact that continue to emerge as the work of the supply chain teams and clinical teams continues. These outcomes are described in the following section.

Visibility and Transparency Supply chain leaders believe that the most important outcome of the Scan4Safety program is in transparency of information that is emerging from inventory and surgical theatres. Inventory brings transparency and control to clinical programs while providing objective data that informs decision-making regarding efficiencies, clinical variation and procurement. Before the initiative, waste was a significant outcome of Scan4Safety, but automation and digitization of data across the inventory management and clinical programs have resulted in the reduction of waste of expensive products: I think the most important thing about the Scan4Safety project, and I’m maybe a little bit biased as well, is the theatre side of things. Because it stacks up; it’s the one thing that is really black and white. … It’s where all your inventory in the hospital is. You need to have that visibility and transparency to lead control. … You then get incredible data that can lead to efficiencies, clinical variation,

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procurement, benefits and real data that enables proper decision-making, rather than just your feelings … . The key dimension of transparency is the importance of objective data that informs decisions, such as product procurement, as well as standardization of instruments or product utilization, such as implants, devices or surgical preference trays. The level of detail in data emerging from point of care scanning and inventory management is substantial: We can go into more detail and we can say, “Okay, this case was done on the 7th of August; Dr. Miller was the lead physician, he was supported by staff. [According to] the encounter number”—that would be the patient’s NHS number—“we can clearly see that they’ve used four St. Jude items there, so they used two lead kits, a connector and a neuro … ,” and it’s broken down there by product number, and lot and serial number. Another trust described the importance of transparency somewhat differently: Waste is huge, so again it goes back to the obvious. What are your expensive products? And when we first started … for example, I might do a stock take, and I might do it with a clipboard, piece of paper, and I would do absolutely every product and count them. Mike might pop down and just say, “I’ll do every other third one. And then I did one last year, let’s just dust that one off and resubmit it.” To touch on a previous discussion about how would you do it differently [in future], I’d probably still say that actually, within theatres, at the point of writing the first business case, we didn’t then realize the opportunities within theatres. Because then, because of the data you’re capturing, you’re capturing staff. So, you’ve got that kind of, well, why is the consultant doing it with four staff and another one doing it with 10? And actually, the one with four is doing it faster anyway, and all that kind of conversation to be had. So, streamlining efficiencies, scheduling and stuff like that, and variation. We’ve also got maybe the tracking and tracing, decontamination as well, in terms of products. And now, because we actually are having a proper conversation about that, and what we use, and when we’re using it, and why we’re using it. You can then start to say, “Hang on a minute, we’re now scanning trays as well. We have like, thousands and thousands of trays here, and every time we use one, it could be 50 quid to clean it, depending on how many items are on that tray.” Or if 12 months have elapsed and we’ve not used it, we’ll still clean it and pay that amount. So actually, now we’ve got that visibility of what we’re using, … we can easily eliminate the ones that we’re not using regularly, and just maybe pay for it to clean without utilizing it. So, you can strip that back to the good old 80/20 rule. But also, you can then start to have meaningful conversations with maybe the clinicians, because you now know the main trays you’re using, you can then say, “Oh, can I just ask you a quick question? On that tray that you use 10,000 times a year, do you use everything on it?” “No, I actually only use 20 percent of it.” “Oh, that’s interesting, because actually, now what we can do is just give you

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that 20 percent on the tray, save probably however amount of money.” It’s now gone down a cycle by 20 quid a clean, but we still use it 10,000 times. And that’s something we didn’t even think about. In one of the trusts managing over £750,000 worth of inventory, project leaders have identified improved financial, clinical and operational performance (21). For example, the introduction of radio-frequency identification tags has eliminated all overnight urgent orderings of stock-out items due to automated ordering; it has automated 100 percent of expiration and recall alerts to improve patient safety, and has reduced aging inventory by 87 percent (21). When products are taken off the shelf, they are scanned before being used in patient care, tracking and tracing the inventory to the patient and to the supervising clinician directly. This same trust maintains a dashboard to monitor progress of key performance indicators, including supply cost per case, GTIN compliance of suppliers, product use and order information.

Labour Savings from Automated Recall Tracking and traceability of products based on unique identifiers (lot number, batch number) proactively and immediately identifies recalled or expired products in the hospital’s system. Proactive alerts of recalled or expired products result in very low risk that an expired product is ever used during patient care. This is in stark contrast to a recent Cardinal study in the United States, which identified that 24 percent of patient care procedures use expired products (22) and over 20 percent of physician and nurse time is spent on inventory management (23). The automated nature of the recall system is described as follows: The other thing that you can spot from this as well, is you’ve got product recall, so if there’s an FDA alert or, you know, we’ve got an issue within the UK … it will come up on the dashboard to say that that [item]has been subject to a field safety notice … [or] this is an expired item, so it’s coming up as a clinical alert. However, in normal procedure, these items are scanned through the normal process. Then we just click “finish” and that’s assigned those products to that patient and procedure. (Supply chain leader) A key feature of the Scan4Safety initiative was to remove clinicians from managing inventory to free up more time for patient care. While the trusts have some measures of labour hours allocated to inventory management versus patient care, metrics were not consistent across all of the sites. However, data reported by GS1 UK and the Department of Health are reporting labour savings associated with 16 FTEs of nurses in each trust based on the outcomes of the six demonstrator sites for Scan4Safety (20).

Supplier Outcomes: A Competitive Advantage The eProcurement policy requirement to adopt global standards for all suppliers has resulted in what trusts view as a competitive advantage for companies that had adopted global standards. Although the adoption process is complex, Scan4Safety teams see

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the potential advantage for suppliers and believe the momentum will build as more trusts implement the Scan4Safety enablers: It’s almost like a competitive advantage now, or they’re giving themselves a disadvantage if they’re not, I think, because the hype in the news is helping as well. I think this Scan4Safety project will be rolling out at a good pace, so it’s not going to go away now. …I think the more Scan4Safety sites that come live, the more noise about getting that one barcode, it will happen. And actually, the suppliers themselves, … all the big pharma, … it’s in their interest to just produce one code and that is, the GS1 data matrix, and that product can go out ever so slightly different. But for a medical device, it’s the same medical device … and that, I think, reduces their manufacturing, so it helps them with their business case internally. (Supply chain leader) To date, there has been limited research on the business case outcomes of global standards adoption for suppliers. Supply chain teams leading the Scan4Safety initiative identify the competitive advantage suppliers have when global standards adoption is completed. This perspective is based primarily on the requirement to meet RFPs for product procurement that now require products to be labelled with global standard identification (barcodes).

Staff Accountability and Patient Safety Impact Point of care scanning offers a traceable, digital record of adverse event reporting. When adverse events are investigated, data from point of care scanning is able to identify the point of care consultant, the identities of the care team, date, time, the products that were used and objective details of each adverse event. This ability to track every patient, product, staff member and location creates a strategy to support accountability of both physicians and nurses for patient care practices and outcomes: We can tell you who was the consultant, who was the care team, where did it happen, what date, time, what was used. And we can pull all that information just to start that kind of investigation. Like the … product that should have been used on a certain procedure, and it wasn’t scanned. So then straight away you had consultants saying, “It’s your fault,” “No, it’s your fault,” when actually, you read there what should happen in that procedure—“Oh, we should always use [product name], it’s not been scanned.” (Clinician leader) One of the trusts is advancing tracking and traceability of staff members further to include tracking qualifications of staff engaged in patient care procedures. The supply chain team in one of the trusts has linked the point of care scanning software to human resources records so that when a staff member scans their ID badge, the system will proactively identify whether the staff member is or is not qualified to conduct the procedure for the patient:

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We are capturing products, patients and places, but we have the capability to capture medical devices … and also packages and anything else. Anything a barcode can capture. … In order to be successful in capturing the safety elements of things, we wanted to put validation in there, so we want it to say, “This product is out of date, don’t use it”; “This member of staff is not trained to use the system—don’t allow them to”; “That [person]’s not trained to use the apparatus to perform the procedure, don’t allow them to.” (Supply chain staff member) The goal of this supply chain initiative to track staff qualifications to deliver care was to create an environment and supporting infrastructure that reduced errors while making sure staff are properly trained and held accountable for conducting care processes they are qualified to deliver. The supply chain data is leveraged to inform “business intelligence” relative to the need for staff training, utilization of staff skills and expertise appropriately to deliver quality patient care: Let’s evaluate what we can from the captured data and then let’s take the volume of that data within our organization, within our departments, across the departments into the organization, by comparing organizations to see what is efficient, what is not efficient, what is safe, what is not safe. And basically, with the [quantity] of that data, and the business intelligence behind it, we get massive opportunities to assist training, … to assist the rotation of staff so that we’ve got equity knowledge of our provision of services, and they’d been safe and successful and the outcomes have been good; that could be deemed an optimum. And if elsewhere it is in excess of that, then that could be deemed a saving. It also means that if there is the use of agencies within the organization, we know what the skills are, we can deploy them and we can make a savings there as well. We can assist staff in documenting their own training record, and we can assist those who train and mentor staff documenting the evidence of their having provided that. (Supply chain leader) This trust has created an impressive system of documenting, tracking and tracing staff skills, knowledge and competencies to deliver care, including students and trainees, to ensure that only qualified, competent staff are delivering care to patients. The scanning of staff qualifications relative to care delivery competencies supports all staff working together to ensure the right staff member is caring for patients they are qualified to care for: We had the table of staff [and] the procedures [or] tasks they could perform, and we had a table linked from the staff to the medical devices [for which] they had recent qualified training. And it took the existence of those different table relationships to allow [the process] to continue. We actually went further than that in the prototype, because in the prototype, … you would select a task; once you were logged in it would limit your range and your list of what you could do based on what you were trained to do. So a porter could only move the patient, and a student nurse may not be able to intubate, those type of things. (Supply chain leader)

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This strategy was implemented in only one of the six trusts, which created a robust system of tracking staff to ensure competency to deliver safe care for patients. This application is a unique feature of supply chain infrastructure, designed and implemented by the supply chain team in this particular trust. All staff are identified and tracked, including the doctors who are present in clinic settings. Staff are tracked for efficiency and safety to document which staff and trainees are rotating to which individual clinical units, the training staff have or do not have, use of agency staff, all tracked relative to care being provided.

Catalyst for Innovation One of the demonstrator trusts quickly realized there were few viable solutions that offered both an inventory management system and point of care features needed to identify patients, staff, products and procedures. The trust implemented the Genesis inventory management system, which has a point of care feature. Although the inventory management aspect works well, there were significant constraints with the point of care features. The cost of the Genesis system for this particular trust was £62,500 annually per site, for a total of £125,000 per year. The team pursued an innovation strategy to design a customized software solution at a fraction of the cost of the Genesis licence for one year. The IT project lead went out to market to find an end-to-end solution that would track products, patients and location, ensure accurate product validation, automated product recall, reporting and event coding, using open-source and open-standards software. They engaged the market to consider end-to-end solutions and determined there was no solution that accomplished what they wanted and needed. There were parts of the solutions that would have to be pieced together to create the entire solution, but nothing that would interface easily to deliver that solution. With approval to design the software, the team mapped out all of the processes and pathways over a 16-day period. A software developer created the customized software tool according to the required specifications—open source, event coding, location (GLN), open standards and scalability. The goal was to create the environment infrastructure to reduce errors and make sure appropriately trained staff deliver care to patients. In many ways, one could describe the system as surveillance over every care process, every staff member and every patient transaction. It creates the transactional record of the staff who were involved and the products that were used, uploaded to the patient record (EMR) to link care processes to patient outcomes. The system proactively identifies risk of error. If the clinician continues with the procedure, the scanner software is designed to identify an error or risk of error at the point of care. Options to continue the care are identified on the scanner, but only when the nurse enters the rationale for continuing to deliver the care into the scanner device. When nurses or staff enter the justification for proceeding with care, the tool creates an objective record to identify the staff who delivered care to a patient, linked to their qualifications to provide specific care procedures. This team has now created the software, Care Scan Plus, an innovative tool being beta-tested in the surgical theatres at the time of this study. The trust team intends to commercialize and market the software tool while implementation in the surgical theatres (ORs) proceeds to complete the Scan4Safety deliverables. The team is completing the next business

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case to procure the Android devices needed to use the Case Scan Plus software, which is a capital cost required for the point of care phase of implementation. In the meantime, the OR theatres were using an alternative point of care technology to meet the DH deadline for point of care tracking and traceability. The implementation of the tool has been challenging, with many glitches in the system. The supply chain team has been assigned to theatres to support clinicians to adopt the point of care scanning successfully to meet Scan4Safety required outcomes. This example of innovative thinking and tool development was evident across all of the trusts participating in the study, although only one of them actually designed the software tool (Care Scan Plus) and has plans for commercialization. The Scan4Safety enablers and prescribed-use cases have set the stage for a variety of innovative applications and uses, limited only by the imagination and insights of each of the teams. Another example of innovative applications of supply chain tracking and traceability is described in the following section.

Internal Supply Chain Optimization The “internal supply chain” optimization is an emerging theme across a number of the trusts. It refers to achieving efficiency and productivity of work routines across all of the staff teams in acute care trusts, by achieving a single logistics strategy across the organization. One of the trust team leaders described the very large number of internal teams that manage product deliveries and supply chain processes for clinical units, including materials management, lab, pharmacy, catering and housekeeping. All of these teams function independently to order and deliver products, manage inventory on clinical wards and deliver services. One trust team estimated that 76 different people across the organization engage in some type of product distribution role in the trust. All of these teams and individuals have the goal of ensuring nursing staff has the products and supplies needed to deliver patient care, yet function independently from other teams. In a number of the demonstrator trusts, an integrated strategy that has one person doing all of the ordering and inventory management for the trust is being trialled. This initiative is described by one leader as the “the well-organized ward” (14). Examples of internal supply chain include the following: We don’t hold any stock in stores, no. And we’re working on the wards at the moment. The ward is down to 11 days’ worth of stock. They just are still working on it because it’s a bit more difficult to reduce that level, but we will be doing that before the end of this year. … We can get a delivery within four hours if there was a major incident. (Clinician leader) The supply chain staff in this trust manages 90 percent of the inventory tracking and ordering, allowing clinical staff to provide more care: We started the roll-out, materials management service, so it meant that there [were] a couple different types of service that we could provide to the area. … Critical care is a good example. We give them a twice-weekly topup service, but we also put the goods away for them as well. So, we’re managing their inventory, I would say probably 85 percent or 90 percent of the time. There will always be areas where they may well get patients that

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they weren’t expecting in critical care. The impact on critical care has been fantastic. They appreciate it. (Supply chain leader) One of the key areas of focus for internal supply chain optimization is to release clinical staff from inventory management functions and accountabilities. Before the Scan4Safety initiative, it was common for clinical staff to manage 80 percent of inventory management tasks, and the supply chain team managed 20 percent. But they have now switched so that the inventory team is in clinical units twice weekly, managing 85 to 90 percent of its inventory tasks, with plans to scale across the system eventually. The strategy started with high-cost units (e.g., ICU, theatres). All logistics were reviewed, including pharmaceuticals, supplies and products stock optimization, starting with the surgical theatres, and then the wards. There remain two challenging areas the trust teams are working on: • Consignment products are difficult to track and trace within the inventory management systems, resulting in trusts not being able to confirm which products used in care are consignment and which are in inventory. This lack of traceability results in challenges with tracking, whether consignment products are used in patient care or remain in inventory. • Loan kits are requested by another organization about twice a week. When there are not enough surgical kits available for booked cases, a surgical team must urgently purchase a loan kit at a very high cost. Teams are working to overcome these two challenges as they progress towards the fully optimized internal supply chain and logistics processes to increase efficiency, reduce costs and strengthen productivity for all teams across the trust organizations. In many of the trusts, point of care scanning of pharmaceuticals had not yet been undertaken. One trust described having the ability to scan and track pharmaceuticals, and has done some test runs, but supply chain leaders do not feel they are ready to fully launch into medication tracking and traceability, given that they have not yet implemented electronic prescribing (or physician order entry) to automate the entire medication management processes. The outcomes and impact emerging from the Scan4Safety program in the initial six demonstrator sites are very impressive and continue to emerge across the sites. The program has clearly created the supply chain infrastructure to automate the tracking and traceability of every product, patient, staff member, care procedure and location of care. This infrastructure has now set the stage for these demonstrator sites to realize the many opportunities to further advance patient safety, strengthen quality of care and achieve the substantive cost savings to advance the sustainability of the NHS health system.

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Summary of Key Findings The Scan4Safety program has documented a significant impact on the quality, safety and financial performance of its six demonstration sites. The program outcomes to date have exceeded the expectations and projections of the Department of Health as the first phase of the program nears completion. The return on investment is quantified at 4:1, and the recurring savings evident in phase 1 are anticipated to generate £30,000,000 of savings every month when the program is scaled across the entire NHS. As reported in a recent presentation (19), the program implementation plan seeks to increase the breadth of the savings for the entire NHS acute sector (Figure 2). Figure 2. Indicative timeline for program rollout across the other 148 acute trusts in the NHS, with supplier milestones

Source: Steve Graham, Scan4Safety: Setting the Standards for Safer Care, November 21, 2017.

By 2022, Department of Health leaders anticipate meeting or exceeding the goal of £1,034,000 in savings across the NHS system. Additional features of the program will likely include new prescribed-use cases and initiatives (e.g., community equipment management; clinical variation analysis) to continue to advance and further strengthen NHS performance. The emerging evidence of impact and return on investment profiled in this case study demonstrates impressive progress towards achieving the vision of Secretary of State Hunt: “making the NHS the safest and most transparent healthcare system in the world.” The strategy and evidence emerging provide global health systems with significant opportunities for collaboration and learning to advance transformative supply chain strategies across global health systems that collectively strengthen patient safety, quality and sustainability of global health systems.

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References 1. The Mid Staffordshire NHS Foundation Trust Public Inquiry. Final Report, February 6, 2013. 2. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry: Executive Summary, February 2013, pp. 4–5. 3. Public Health England. Public Health Profiles. 4. NHS Health Confederation, Annual Conference and Exhibition, July 19, 2016. 5. NHS Improvement. Provisional Publication of Never Events Reported as Occurring Between 1 April 2016 and 31 January 2017. 6. National Information Board. Personalised Health and Care 2020: Using Data and Technology to Transform Outcomes for Patients and Citizens—A Framework for Action. November 2014. marketing-documents/nhs_england_nib_report.pdf?la=en. 7. Department of Health and Social Care. 2015. Operational Productivity and Performance in English NHS Acute Hospitals: Unwarranted Variations. 8. Finance & NHS Directorate, Procurement, Investment & Commercial Division (PICD). NHS eProcurement Strategy, April 2014. 9. GS1 UK Healthcare Conference 2016. Importance of GS1 Standards in Delivering Efficiency and Productivity Programmes. 10. European Commission Public Health. Medicinal Products for Human Use. Falsified Medicines Directive, July 2011. 11. Terence Stephenson, Chair, General Medical Council. Passionate About Patient Safety. GS1 UK Healthcare Conference, 2017. safety_professor_terence_stephenson.pdf?la=en. 12. Terence Stephenson, Chair, General Medical Council. Presentation: GS1 as a Patient Safety Initiative, April 21, 2016.

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13. Scan4Safety. Our Journey. 14. Lorna Wilkinson, Adoption of SG1 Standards 18 Months In: A Chief Nurse Perspective. Scan4Safety, October 2017. 15. Lorraine Bewes, Chair of the NHS London Procurement Partnership and Director of Finance, Chelsea and Westminster NHS FT. Benchmarking and Analytics Service for NHS London Procurement Partnership Members, March 6, 2013. 16. GS1 UK. What Is PEPPOL?, July 27, 2014. 17. Strategic Marketplace Initiative (SMI). Shaping the Future of the Healthcare Supply Chain. Perfect Order. 598 - /. 18. Keith Jones, Clinical Director of Surgery, Derby Teaching Hospitals NHS Foundations Trust, presentation. GS1 Standards Improving Clinical Effectiveness and Patient Safety, April 21, 2016. 19. Steve Graham, Scan4Safety: Setting the Standards for Safer Care, November 21, 2017. 20. Scan4Safety. Benefits. 21. NHS Trust: The Leeds Teaching Hospitals. Optimising the Supply Chain and Improving Patient Safety as Part of Scan4Safety—The Leeds Way, April 2017. 22. Cardinal Health. The Biggest Untapped Resource at Your Hospital? Your Supply Chain., February 14, 2017. 23. Cardinal Health. Survey Finds Hospital Staff Report Better Supply Chain Management Leads to Better Quality of Care., February 15, 2017.

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Contributors The World Health Innovation Network would like to acknowledge: GS1 UK Northwest Procurement NHS Dr. Charles Alessi, Public Health England GS1 Canada

Produced by: Dr. Anne Snowdon, Academic Chair, World Health Innovation Network, and Scientific Director & CEO, Supply Chain Advancement Network in Health, Odette School of Business, University of Windsor Original release date: February 2018 World Health Innovation Network T: 519.253.3000 x6336 E: Windsor, Ontario