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Introduction While quality and safety have been the fundamental goals of all global healthcare systems from both a patient and a provider perspective, performance of North American healthcare systems remains far behind that of other OECD countries, ranking 10th for Canada and 11th for the United States (US) compared to the other 11 countries in the OECD group. 2 Despite many well-funded initiatives to strengthen quality and safety, healthcare systems worldwide have not experienced significant improvement in these core areas. Patient safety is a particular challenge despite more than two decades of research and safety initiatives to define the problem, at both a country and the global level. Medical error, a core element of patient safety, has now become the third leading cause of death in North America, behind heart disease and cancer.9,24,25 Although there is growing awareness of the challenge of patient safety, there has been little evidence of improvement in the increasing rates of deaths and serious injury related to error and adverse events. Moreover, although the prevalence of adverse events and safety challenges has been widely reported related to hospital care, it is not well documented in community and long-term care settings. As Rafter3 identifies: “Patient-safety experts should question why, after 30 years, there has been so little evidence of overall improvement.” Not only are adverse events, particularly those that are preventable, devastating for patients and their families; they are very costly to the patient, to the organization and to the healthcare system. The purpose of this paper is to propose a new strategy for addressing the seemingly intractable challenge of patient safety and the growing rates of death and injury associated with adverse events in healthcare systems. We first examine the occurrence of adverse events in healthcare across global jurisdictions to consider the magnitude and prevalence of this challenge. Lessons from other sectors, such as grocery and retail, airlines, banking and automotive, demonstrate how highly visible systems that track and trace people, processes and products can be translated and applied to the health sector to advance safety and reduce error. We then reframe the challenge of patient safety in healthcare systems from one focused on types and rates of error, towards one that examines the features of health system environments that promote safety and the delivery of safe care. We propose creating a highperforming supply chain strategy to create visibility by embedding the necessary processes and tools into the infrastructure of health system environments. The term “visibility” in this paper is defined as the ability to see or be seen; the quality or state of being known to the public, to providers, health system leaders and funders. It is a key strategy that not only offers healthcare systems greater clarity and accountability to the public they serve, but also guides how clinical infrastructure tools and processes can strengthen health system safety outcomes. The concept of visibility is an important strategy for achieving a key value proposition and provides opportunity to strengthen system outcomes and visibility for patients, for provider teams, for healthcare systems, for industry and for the general public. Finally, the paper examines the value proposition of restructuring clinical environments for health sector stakeholders including patients, providers, healthcare institutions, industry partners and health system funders and regulators. Ultimately, transforming clinical environments to adopt highly visible supply chain tools and strategies will create environments for patients and practitioners that are safe and effective, and that make it nearly impossible for adverse events to take place.

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The Growing Prevalence of Adverse Events and Medical Error in Healthcare Systems Patient safety first emerged as a key health system priority almost two decades ago in 1999, when the Institute of Medicine published the seminal report, To Err is Human.4 Since then, many subsequent studies have reported on the prevalence of adverse events. Adverse effects are defined as unintended injuries resulting from care processes or medical management, rather than from disease processes, that result in serious impairment, disability or death for patients.5 The Institute of Medicine report was the first to try to quantify the scope of the issue. It estimated that 44,000 to 98,000 people die each year in US hospitals due to potentially preventable adverse events.4 In the United Kingdom (UK), the report An Organisation with a Memory (2000) found that every year, 850,000 patients admitted to hospital in the National Health System (NHS) experienced an adverse event.6 The report further estimated that 60,000 to 255,000 cases (10.8% of patients admitted to hospital) resulted in permanent disability or death annually due to adverse events, nearly half of which (46%) were deemed preventable.7 Similar findings have emerged in Canadian studies. The Canadian Adverse Events Study revealed that patients experienced harm from adverse events at a rate of 7.5% of hospitalizations,8 with 36.9% of these events considered highly preventable. These findings revealed that 23,000 people annually (or 63 Canadians every day), die as a result of preventable adverse events.* More than two decades of research has provided evidence of the high rates of preventable deaths, demonstrating the growing prevalence of adverse events affecting thousands upon thousands of patients worldwide. Figure 1 illustrates a sample of studies that have examined the prevalence of deaths related to adverse events. These published studies are from Canada, the US and Britain from 1999 to 2016. All of these studies focus on rates of preventable deaths in hospital settings. There has been remarkably little focus on rates of preventable deaths or injury in other healthcare settings, such as long-term care or community-based care. Of particular note is the most recent study by Makary and colleagues, 9 which estimates that 251,454 people experience preventable deaths every year in the US. This translates into 688 deaths every day in the US health system. To put this figure into perspective, this is equivalent to two jumbo jet plane crashes every day. What is overwhelmingly clear is that adverse events are preventable, yet they continue to result in the deaths of far too many citizens in the US, Canada and the UK, among many other countries. There are many additional studies of patient safety outcomes (far too many to list), all of which provide growing evidence of the magnitude of the problem facing healthcare systems. While reports have made a variety of recommendations to achieve safer outcomes in healthcare, the rates of adverse events remain unchanged. If anything, deaths due to adverse events are growing over time, as healthcare services become more complex and patients experience increasing health challenges due to growing rates of multiple comorbidities. What is particularly notable is that this growing prevalence of error is * This

is thought to be a conservative estimate.

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common across many global jurisdictions; no health system jurisdiction has “cracked the code” in terms of reducing preventable health errors. Figure 1: Preventable Deaths Due to Adverse Events,* 1999–2016

(Sources: 4, 7–17)

*The definition of adverse events varies across studies 3


The majority of these reports have focused their research efforts only on safety in hospital settings. What may be more alarming are the rates of error that are not captured in these reports—deaths and harm experienced by patients in the community (home care, long-term care, complex care and rehabilitation settings), whether from prescription drug errors, falls, neglected or incorrect diagnoses, and nursing home or community agency errors. These errors are less often captured or described in the current patient safety literature. Although there is limited evidence of adverse events in home care, long-term care or other community settings, the rates of adverse events suggest these are as high, if not higher, in these settings (Figure 2). Specifically, the rate of adverse events in the Canadian Adverse Events Study8 was estimated at 7.5% of hospital admissions; in the Canadian Patient Safety Institute’s Safety in Home Care study, the rate of error for 2009 was 13.31%,18 nearly double the rate in hospitals. Figure 2: Adverse Events in Community Care in Canada

(Source: Canadian Patient Safety Institute18–22)

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In hospital settings there may be much more substantive documentation of care processes and adverse events than there exists for home, primary care and community care settings. The current estimates of adverse events are only able to capture adverse events recorded in patient charts, and these events are known to be under-reported as much as two-thirds of the time.23 Thus, not only are the rates and prevalence of reported adverse events growing; these estimates of patient harm or death may very well be only the “tip of the iceberg.” Nevertheless, the prevalence of death due to adverse events is now so high that it is reported to be the third leading cause of mortality in both the US and Canada; the only diseases killing more Canadians and Americans each year are cancer and heart disease24,25 (Figure 3). Figure 3: Causes of Death in Canada

(Source: Data derived from “Leading Causes of Death” [Statistics Canada, 2012] and Canadian Adverse Events Study [Baker, 2004])

In addition to research documenting the prevalence of adverse events in healthcare systems, there has been decades of research on how to improve safety in healthcare. The emergence of patient safety organizations (such as the Canadian Patient Safety Institute) following the early Institute of Medicine report and the Canadian Adverse Events Study has resulted in a focus on safety education and awareness and promoting a safety culture in clinical settings. Although these are very important steps in addressing patient safety challenges, we propose building on this work to focus on how clinical environment infrastructure can be transformed by leveraging digital tools for tracking and traceability. Such direct supports would enable clinical teams and administrative processes to reduce adverse events in healthcare settings. The next section profiles what healthcare systems can learn from other sectors that have created environments that are highly visible to stakeholders. These industries have transformed to allow the risk of error to be proactively identified to enable interventions before an error takes place, rather than retrospective approaches that focus on learning from error that has already caused harm.

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What the Healthcare Sector Can Learn from Other Industry Sectors The challenge of transforming a system as complex as healthcare is a daunting task. However, transformational change related to consumer safety initiatives has already occurred in many other industry sectors that have achieved tremendous impact in terms of safety, efficiency and performance. From these other industries, we can learn what a highly effective supply chain environment may offer health systems. There are numerous examples: food safety in the grocery industry; automotive safety for vehicle occupants; and airline safety for passengers. All of these business sectors have welldeveloped supply chain management processes, which are viewed as strategic assets that contribute directly to ensuring the safety of their products and services. The airline industry provides a tangible example of a sector that engages supply chain processes to achieve safety goals and outcomes. In the airline industry, every passenger of every flight carries a boarding pass with a barcode that identifies the passenger and the flight. This ensures that travellers board the correct flight, sit in the correct seat and arrive at their destination safely. When airline staff scan the passenger’s boarding pass, they are immediately informed by visual monitors whether the passenger is boarding the correct flight at the designated gate. If the information is correct, a large green check mark appears on the screen; if it is incorrect, a large red “X” appears, cueing the agent to intervene and prevent the passenger from boarding the plane. This proactive monitoring system achieves an important “doublecheck” for gate agents to overcome the risk of an agent’s misreading the boarding pass and passenger identification. The key features of the system are the tools embedded in the working environment to automatically scan and display information to alert staff to potential adverse events before they happen. This enables staff to recognize high-risk situations and intervene accordingly to ensure safety for passengers and the airline industry more broadly. Although these tools have not completely eliminated error or adverse events, they have substantially reduced the frequency of error in this industry. In healthcare, there is no such system that proactively identifies a potential risk for patients. Imagine the scenario if the airline tools were applied to healthcare systems: the nurse might scan a patient’s identification band as the patient is wheeled into the operating room to ensure that the right patient is entering the correct operating room with the right surgical team ready to conduct the correctly planned surgical procedure. The patient’s identification and surgical procedure would appear on an overhead monitor so that the entire medical team could see the information and validate the exact surgical procedure to be conducted on the exact surgical site (for example, left hip vs. right hip) before the procedure begins. This dynamic system of proactively double-checking for clinical teams, using visual cues on a monitor, could be a key feature of healthcare environments to reduce the risk of preventable errors, such as administering the wrong medication, conducting the wrong surgery, or administering the wrong tissue or implant during a procedure, all of which are events that should never happen in health systems. One of the most critical limitations of clinical environments in healthcare systems today is the absence of tools that track and trace patients, products and procedures to create system-wide visibility of care processes and product use (for example, medications, devices and implants) in patient care.1,26 Unlike 6


many other sectors, there are very few such systems in healthcare environments that identify the potential risk of an adverse event at the operational level. In essence, most other industries or sectors have the infrastructure in place to reduce the occurrence of errors. For example, banking has automated tracking of all transactions whereby unusual transactions are flagged immediately and all future transactions are stopped to mitigate the risk of theft or counterfeit activities as quickly as possible. This system relies on evidence-informed algorithms to alert banking officials to high-risk situations of fraud or theft. Yet in healthcare, these tracking tools do not exist in most clinical settings, leaving clinical environments to rely on staff and health professionals to remember to manually check and double-check to reduce the risk of adverse events. With a predominantly manual system, there is very little opportunity to create automated algorithms to alert clinicians to situations that place patients at risk. This reliance on human behaviour to check and double-check has been the primary strategy of patient safety efforts to date, focused on educating provider teams to raise awareness of safety risks and build a safety culture. However, these efforts have not been effective in reducing the growing rates of adverse events, particularly given the increasing complexity of health system environments. Just as other industry sectors have already demonstrated, there is a need for system infrastructure tools that enable and empower providers to deliver the safest care possible, with automated checks and double-checks in the clinical environment to make the occurrence of adverse events far less likely. An underlying premise of this paper is the suggestion that adverse events, or medical errors, are an outcome of a lack of well-developed supply chain infrastructure in clinical environments. A welldeveloped supply chain creates the visibility to support clinician teams in delivering health services effectively and safely. Comparisons with other business sectors that have successfully integrated supply chain management in complex environments illustrate how profoundly underdeveloped the supply chain processes are in healthcare. In the following section, we examine the key features of health system environments that contribute to poor visibility. Healthcare systems need to design and implement strategies to create health system environments that enable and empower clinical teams to protect patients from error and reduce the risk and prevalence of adverse events.

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Challenges in Current Health System Environments The concept of the supply chain in healthcare is not well understood or developed in most global healthcare systems. We suggest that there are at least four challenges in current health system environments related to healthcare supply chain that are contributing to the serious issue of adverse events and rising patient safety concerns. 1.

Lack of Automated Alerts for Staff to Proactively Manage the Risk of Adverse Events

There is very little “line of sight”—visibility—in the key conditions that contribute to adverse events in healthcare systems. Take, for example, joint replacement surgery. Most patients in the world have no ability to identify the hip or knee implant that was used during their surgery. In the event of a recall or a failure of the joint implant or product, there is almost no way to identify, at the level of the individual product and patient, which patients received the defective device or implant. Few tools are currently available in healthcare environments to track and trace what products are used in individual patient care processes, where a product was manufactured and when, or how different products link to individual patient outcomes. In countries such as Canada and, to a large degree, the US, there is no national-level infrastructure that evaluates adverse event outcomes related to products such as joint implants; nor is there a way to alert health system leaders to risk when these products enter the market and demonstrate adverse outcomes for patients.1 Registry infrastructure in the UK has shown significant risk reduction for populations by identifying adverse outcomes early, issuing the appropriate alerts and removing products from the market before thousands of patients are exposed to risk over prolonged periods of time.27 Although there are many organizations that track use of products in patient care, they most often use proprietary information technology (IT) infrastructure barcoding, which is not standardized. Therefore, these products can only be tracked internally to individual organizations; there is no ability to track and trace individual patients and product use across organizations, regions or jurisdictions and thus no ability to disseminate information broadly in the event of product failure. Imagine the consequences if the airline industry used the same approach to safety reporting! If the Airline Industry Reported Adverse Events as Healthcare Systems Do A malfunction in an airplane engine is reported and filed with supervisors using paper-based reports. The airplane takes off, carrying its passengers, with little attention to the safety risk the malfunction may present. There is no analysis of the risk the problem presents to passengers on the flight, and no alerts to other pilots flying similar aircraft that would reduce the risk of the same engine malfunction on other runways. If the plane crashes and passengers don’t survive, the investigation report is completed and filed away by the airline, while company operations proceed as usual with no public reporting or analysis of what happened. It is hard to imagine such a poor system of reporting and dissemination of findings in the airline industry. 8


The majority of business sectors outside of healthcare employ in their day-to-day operations advanced supply chain systems with embedded tools and technology. The tracking and tracing of products, processes and people creates visibility in these highly effective systems, the “ability to see and be known” to system stakeholders. This visibility creates strategic value that enables the entire system to measure the effectiveness, efficiency, performance and value of every step of the business process. For example, there are currently a number of software products that use transactional data sources (such as admitting/discharge/transfer data and scheduling data) to track and trace patients in hospitals. These applications make it possible to identify the movement of patients and completion of care processes such as admissions, transfers from emergency departments, housekeeping, completion of diagnostic tests or procedures, and discharge. Such tools provide visible, nearly real-time data for clinical teams to optimize patient care flow across health organizations. Data flows from existing hospital systems are captured in nearly real time, as patients move through the various care processes in the hospital setting. Yet, these tools do not identify individual patients or the products used during care procedures to offer the visibility needed to enable staff to prevent adverse events. If existing hospital software tools could be strengthened to identify individual patients and products used in care processes in near real time, then staff and clinical teams could apply their unique expertise and experience to identify and implement strategies, such as automated double-checks and alerts, to prevent adverse events. Such tracking tools could also enable and inform accountability structures to support quality and safety of patient care, ensuring that clinical teams are effectively managing safety and risk to protect patients. But because no such tools are used in community, home care or primary care settings, there is still no way to track adverse events across the continuum of care. The potential to do so can be harnessed only if clinical environments provide clinician teams with the necessary tools. In the US, the Food and Drug Administration (FDA) monitors product recalls; then, health plans and health systems are required to notify patients about the recalled device or implant. While this system has not yet adopted global standards to identify individual products used in healthcare, it is mandated to do so in future. Although there has been progress in the US, the speed with which these notifications occur is limited; in some cases, recalled devices are still used for patient care because the notifications did not reach the providers quickly enough for them to retire products and thus protect their patient populations.27 2.

Inadequate Reporting of Adverse Events: “You Can’t Manage What You Don’t Measure”

Healthcare systems have focused substantial effort on measurement of utilization of services such as the number of annual emergency department visits, surgical wait times, patients’ experience and outpatient procedure wait times, which are tracked and reported publicly in most healthcare systems in North America and globally. These same measures are captured in global performance rankings such as those published annually by the Commonwealth Fund. The well-known phrase, “You can’t manage what you don’t measure,” captures one of the most substantial challenges related to clinical environments and contributes to limited progress in patient safety. After more than 20 years of research and best practice in patient safety, there remains a reliance on chart reviews and retrospective reporting to monitor adverse events, primarily in hospital settings. 9


Health system stakeholders use retrospective chart reviews to gather data to understand root causes of adverse events such as medication errors or falls. The key word here is “retrospective”; health teams rely on learning about adverse events after they have happened. The current evidence profiled in all of the patient safety studies identified (Figure 1) relies solely on estimates of adverse events in hospitals using retrospective chart review data. This approach presents two significant challenges. One challenge is the lack of evidence of the prevalence or root cause of adverse events in clinical settings such as primary care, long-term care or home care when adverse event outcomes, such as surgical infections, are most likely to be identified. Thus, provider teams or health system leaders have limited ability to prevent adverse events when they are not measured, reported or shared from one clinical setting to another. A second challenge is the reliance on chart review methodology to determine the nature and prevalence of adverse events. While chart reviews are important to capture root cause analysis, this is a limited approach to day-to-day tracking, measuring and reporting of adverse events, compared to enabling clinicians to intervene effectively to prevent such events from happening during patient care. The advent of patient safety organizations (PSOs) in the US has made important progress in providing the infrastructure for reporting, aggregating and disseminating safety information, yet adverse event reporting relies on providers to complete adverse event reports. These retrospective reports do not capture details related to products and patients that are necessary to support root cause analysis across jurisdictions and healthcare organizations using automated tools and analytics.28 Tragically, by the time evidence of the rates and types of errors or adverse events is published in empirical research, there are hundreds, if not thousands, of deaths (or preventable events leading to serious harm or death) across entire healthcare systems. In the US, if a manufacturer receives an adverse event report, it is required to send the report to the FDA, as specified by that agency’s regulations.29 The following excerpt from the UK illustrates the magnitude of the challenge of adverse event reporting for just one classification of healthcare products—joint implant devices: “When failures take a long time to develop, many faulty products can enter the market. In the case of the ASR and metal-on-metal implants it took 4–5 years before evidence was accumulated and reported. We are left with more than 500 000 patients with metal-on-metal prostheses in the USA and more than 40 000 in the UK who are at elevated risk of device failure, which will inevitably result in the burden of further surgical treatment as well as billions of dollars in costs to taxpayers.”1 To date, we can find no evidence of healthcare systems that have documented and disseminated adverse event outcomes in near real time at the clinical unit level. Thus, provider teams are unable to identify the risk of preventable events on their own clinical units, or across their organizations, and intervene quickly enough to prevent additional, similar events. Simply put, clinical teams cannot adequately address or prevent adverse events when they have no line of sight towards how these events happen, when and why they happen, and what key changes in the clinical processes need to be addressed to prevent such events from recurring. 10


There can be no impactful strategy for reducing harm to patients due to error if clinical teams have no on-the-ground, real-time tracking and reporting that is flexible enough to enable them to prevent such events for future patients. Traditional efforts to detect adverse events have focused on voluntary reporting and tracking of errors. However, researchers have established that only 10% to 20% of errors are ever reported and, of those, 90% to 95% cause no harm to patients, suggesting harmful adverse events are less frequently reported.12 Hospitals need a more effective way to identify events that do cause harm to patients in order to quantify the degree and severity of harm, and to select and test changes to reduce harm. 30 Community care settings need to develop adverse event reporting tools to support clinical teams to identify adverse event prevalence and severity across the continuum of care. Tracking adverse events over time is a useful way to tell whether changes being made are improving the safety of care processes. The Institute of Health Information has developed The IHI Global Trigger Tool for Measuring Adverse Events to provide an easy-to-use method for accurately identifying and measuring the rate of such events over time. The Trigger Tool methodology relies on a retrospective review of a random sample of patient records using “triggers� (or clues) to identify possible adverse events. 30 Although the IHI tool offers an opportunity to better capture adverse events, it may also place additional burden on clinicians to complete the chart review data collection and to analyze outcomes that, in any case, offer limited scalability across entire health systems to advance patient safety outcomes. The critical safety challenges in health systems today are the failure to implement the tools clinicians need to identify risk of error and capture evidence of adverse events at the operational level (that is, patient-level, product-level and clinical setting details) and the lack of adverse event reporting across other healthcare settings such as home care, primary care and long-term care. As a result, there is no visibility across healthcare systems regarding where, why or when adverse events happen, and no meaningful evidence to support clinician experts in designing and testing prevention strategies to reduce the prevalence and impact of such devastating events for patients and families. 3.

Lack of Standardization in Adverse Event Reporting Across Systems

Another infrastructure challenge in healthcare is the lack of standardization in adverse event reporting. Current adverse event reporting systems are predominantly focused on events in hospitals, with limited reporting in other settings, and no standardization of reporting across healthcare systems. In addition, reporting structures and systems vary widely and are not standardized or universal in terms of identifying processes, products or patient situations and outcomes. Summative adverse event reports are rare and do not account for the events, processes and products used in clinical care for patients across organizations or settings. The outcome of this lack of standardized reporting is that information cannot be shared across organizations and global healthcare systems. One contributing factor associated with lack of standardization is that adverse events are typically reported by clinicians who most often manually complete an adverse event report (structured uniquely in each organization), either paper-based or online, to describe the events and the outcomes experienced by the affected patient and family. Adverse events are typically submitted to senior leaders in the organization responsible for patient safety. However, communication of adverse event outcomes, 11


which might enable clinical teams to learn about and create safety interventions across the organization, is often limited. Although organizations are increasingly (but by no means universally) using electronic adverse event reporting systems, the lack of global standards for reporting has resulted in a dearth of detailed information on products or care transactions that contribute to objective accounts of adverse event outcomes. Given the limitations of current reporting, there are few opportunities for learning from error or adverse events across systems or organizations. The complexity of healthcare varies widely, as do the clinical environments and policy structures that underpin the operations of healthcare systems. However, dynamic and frequent reporting tools could enable clinical teams, particularly those working in highly specialized settings, to respond more rapidly and make changes in clinical processes that would decrease the risk of adverse events, but the current system offers few sources of systematic and objective evidence to support such learning. Similarly, there are no sources of patient-level information to assist manufacturers in informing the design and development of the next generation of products and technologies. As a result, all healthcare system stakeholders (policy makers, clinicians and provider teams, manufacturers, regulation agencies) rely primarily on published research data describing rates and type of adverse events—sometimes years after the fact—in order to learn about the magnitude and seriousness of safety events. Another limitation is that few system-level adverse event outcomes are reported publicly by healthcare systems. The UK has taken the bold move of publicly reporting safety and effectiveness of health services delivery, posted routinely on public websites,31 to inform the population of safety and performance right down to the level of individual clinics or organizations. Such public accountability may be one reason that the UK is ranked first among all OECD countries in health system performance. The NHS has also made substantial investments in health system infrastructure to create the tools for use in clinical environments to track and trace patients, care procedures and processes, as well as products used in clinical settings. The NHS system has not yet linked traceability of processes and products to patient outcomes or safety events; however, they are well positioned to do so. The US has implemented hospital rankings in the Hospital Compare reports on the Web and also have sites for nursing homes and other medical services, with physicians due to be ranked soon.32 However, the information provides few details on patient safety (for example, it identifies mortality rate simply as above or below the national average) to assist patients and families in making informed decisions about accessing services. To date, despite significant numbers of people experiencing harm or death due to adverse events, the public and other healthcare system stakeholders remain largely unaware of the nature of adverse events, their root causes and the environments in which they occur most frequently. In Canada, the lack of internal reporting within organizations (such as hospitals) means there is no opportunity for learning across clinical units, organizations or healthcare systems. In the US, although there is greater uptake of digital reporting, substantial barriers to dissemination exist related to challenges of legal liability and physician resistance.33 We could find very few examples of external reporting strategies made publicly available so that citizens and taxpayers can better understand the nature of health system outcomes such as error or adverse events. There are few “scorecards” specifically for adverse events reporting that would provide incentives for healthcare organizations to implement safety 12


tracking, tracing and reporting in clinical environments. Although many organizational performance scorecards contain safety indicators, there is no comparability across organizations owing to lack of standardization and insufficient detail to inform health system leaders on how best to improve patient safety. In addition, because of the lack of public reporting, healthcare organizations are not able to identify and learn from the evidence of error in the system. 4.

Outcomes of Healthcare Environments: The Emergence of “Never Events”

There are some adverse events that should just never happen in healthcare, when “never actually means never.” For example, a patient should never get the wrong medication that results in permanent harm or death. A patient should never receive the wrong surgery, such as replacing a healthy right hip instead of an arthritic left hip, or placing a new lens in a healthy eye rather than the one that has the cataract (Table 1). Table 1: Never Events for Hospital Care in Canada Never Events for Hospital Care in Canada, 2015 1. Surgery on the wrong body part or the wrong patient, or conducting wrong procedure 2. Wrong tissue, biological implant or blood product given to a patient 3. Unintended foreign object left in a patient following a procedure 4. Patient death or serious harm arising from the use of improperly sterilized instruments or equipment provided by the healthcare facility 5. Patient death or serious harm due to a failure to inquire whether a patient has a known allergy to medication, or due to administration of a medication where a patient’s allergy had been identified 6. Patient death or serious harm due to the administration of the wrong inhalation or insufflation gas 7. Patient death or serious harm as a result of one of five pharmaceutical events 8. Patient death or serious harm as a result of failure to identify and treat metabolic disturbances 9. Any stage III or stage IV pressure ulcer acquired after admission to hospital 10. Patient death or serious harm due to uncontrolled movement of a ferromagnetic object in an MRI area 11. Patient death or serious harm due to an accidental burn 12. Patient under the highest level of observation leaves a secured facility or ward without the knowledge of staff 13. Patient suicide, or attempted suicide that resulted in serious harm, in instances where suicide prevention protocols were to be applied to patients under the highest level of observation 14. Infant abducted, or discharged to the wrong person 15. Patient death or serious harm as a result of transport of a frail patient, or patient with dementia, where protocols were not followed to ensure the patient was left in a safe environment (Source: Canadian Patient Safety Institute, Never Events for Hospital Care in Canada, 2015 34)

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Never events have now emerged in the US, the UK and Canada as the most devastating adverse events that cause significant harm. They are defined as “patient safety incidents that result in serious patient harm or death and that are preventable using organizational checks and balances.”34 Never events may be the emerging “canary in the tunnel” that further illustrates the inadequacies of the clinical environment in supporting safe and effective clinical care for every patient. In order to eradicate never events, health system environments require dynamic capturing and reporting of health system processes to proactively alert clinical teams to situations that are high risk for adverse events or devastating outcomes for patients. Rethinking and redesigning the tools and processes of clinical environments along the lines of supply chain strategies that are so successful in other industry sectors would offer a new approach to achieving safer patient care. Nearly every other business sector in the world has a well-developed supply chain, a strategic asset that contributes directly to ensuring the safety of their products and services through highly visible supply chain systems. Business leaders have significant expertise in supply chain strategy, whereas health system leaders lack this expertise largely due to limited curriculum in health management programs. The time has come for healthcare to learn from these other business sectors, leverage the existing knowledge of best practice translated for the healthcare context, and implement the infrastructure tools already in use in health system environments to make adverse events far less likely to happen. There is evidence that transforming clinical tools in healthcare environments can have a positive and lasting impact on protecting patients and delivering safe and effective healthcare. The next section profiles two examples of transformational change that redesigned the day-to-day environment of people’s lives to improve health and safety outcomes for entire populations, and that remain highly effective today.

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Evidence of the Influence of Environment Healthcare is a knowledge-based sector that requires tangible evidence to support system change. To this point, we have proposed that it is the lack of infrastructure in clinical environments that contributes to the persistent lack of improvement in patient safety outcomes in healthcare systems. What is the evidence that transformational change in environment can achieve significant impact, such as reducing adverse events? The evidence for achieving transformational change in healthcare systems comes from two real-world examples that demonstrate how changes in the environment led to substantial and long-lasting changes in the health and safety of entire populations. These two cases demonstrate the importance and relevance of the environment in successfully creating change that led to improved health and safety at the population level. 1.

Public Health: The Success of the Anti-Smoking Campaign

The challenge of getting people to stop smoking in order to support personal and population health and wellness was thought by some in the 1970s and ’80s to be insurmountable. Tremendous effort and investment by public health organizations went into educating populations about the hazards of smoking. Public health officials designed multi-modal programs and outreach campaigns to educate people on the negative health risks and assist them in quitting and remaining a non-smoker. Although these approaches were important in socializing the idea of the harmful outcomes of smoking, it wasn’t until policy changes altered day-to-day environments that people began to kick the habit. In every workplace, every public office building, every airport, school or public transportation system in Canada, policy created environments where smoking was illegal. Now, Canada boasts much lower rates of smoking than most other countries in the world. While education and awareness campaigns were certainly helpful, they were not enough to substantively change Canadians’ smoking behaviour; it was also critical to create the conditions in the day-to-day living environments of Canadians that made it much more difficult to continue smoking.35–37 The outcome of this successful strategy remains highly effective decades later, as Canada continues to lead many countries in achieving lower smoking rates.38 Although Canadians continue to smoke, they do so in substantially fewer numbers, a trend that has been sustained for over a decade (Figure 4).

Prevalence

Figure 4: Prevalence of Smoking in Canada Over Time

Year (Source: Government of Canada, Canadian Tobacco Use Monitoring Survey 39)

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2.

Automotive Industry: Changing Vehicle Environments to Achieve Safety Outcomes

The use of seat belts to keep passengers safe in vehicles was a significant challenge for the automotive industry in the 1960s and ’70s, when vehicle crashes were a leading cause of death. While the use of seat belts was proven not only to save lives but to spare passengers serious injury in potentially lethal accidents, seat belts were often not used by drivers and passengers. Today, the majority of drivers and passengers use seat belts. How did this shift in behaviour happen? The automotive industry saved thousands of lives annually simply by changing the interior environment of vehicles, making it nearly impossible to avoid using seat belts and air bags, both of which greatly reduce the risk of death and injury. The interior environments of vehicles now have a warning buzzer that sounds within moments of starting a vehicle if the seat belt is not fastened. The buzzing is so annoying that the driver and passengers buckle their seat belts just to avoid the sound. Air bags were an additional innovation in safety that were designed to be integrated into the vehicle as a completely passive feature; they inflate on impact, protecting the occupant from any intrusion into the passenger space during a crash (a common cause of injury in a collision). The introduction of air bags created an environment that minimized the risk of steering wheel injuries (chest trauma from the steering wheel compressing the chest wall on impact), which were associated with a very high incidence of death. Now, most vehicles have curtain air bags that create a life-saving cushion around the entire vehicle interior to protect occupants and reduce the risk of injury. Although injuries still occur in vehicle crashes, seat belts and air bags in vehicle environments have greatly reduced the incidence of death and injury. Emerging innovations in vehicle interiors continue this highly successful strategy, including autonomous driving systems that make it more difficult for drivers to make an error that may result in a crash or injure a pedestrian, and sensors on steering wheels that detect alcohol and prevent the vehicle from starting if the driver is intoxicated. Innovation and Environments These two examples of highly effective and scalable environmental strategies offer greater protection from harm. They set the stage for considering how patient safety in healthcare systems may be advanced by creating the conditions within clinical environments that reduce the risk of adverse events. Over the last several decades, patient safety initiatives have focused efforts on education and awareness to create a culture of safety in clinical settings, not unlike the early approaches to quitting smoking or using seat belts. But as in the past, knowledge and awareness may not be enough to create safer environments. Health system environments that have high levels of visibility bring to patient safety what anti-smoking laws and vehicle safety systems achieved in communities and in vehicles. Tools in clinical environments are needed to enable clinician teams to identify the risk of harm to patients through automated alerts, so that they can intervene to protect patients and reduce the risk of adverse events—not only in hospitals, but also in home care, long-term care, primary care and all other healthcare settings. Further, visibility in rates and types of adverse events experienced by patients across the continuum of care also offers objective and more accurate reporting. Greater accuracy can serve as a powerful motivation 16


for healthcare professionals to intervene more effectively in preventing adverse events, thereby increasing care quality and safety in patient outcomes. A fundamental assumption in this paper is that a fully visible, transparent health system will not only improve patient safety, but also holds the key to achieving value in healthcare through objective, accurate measures of the value that healthcare systems deliver for their patients and, more broadly, for the populations they serve. In this paper, “value� is defined from the perspective of health system stakeholders, namely, patients and families, provider teams and clinicians, health organizations (hospitals, community care), industry (manufacturers of products or service providers) and policy makers. All of these stakeholders share a mandate to ensure that high-quality healthcare is delivered safely, efficiently and effectively. This mandate would contribute to the sustainability and performance of healthcare systems globally.

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Creating Visibility in Clinical Environments in Healthcare Systems In the previous sections, we documented the significant and growing challenge of safety in healthcare systems, namely, the increasing rate of deaths due to adverse events that are preventable. Evidence from both public health and the automotive–transportation sector supports the proposition that creating clinical environments that enable teams to deliver safe care is an important strategy in advancing the safety agenda in healthcare systems, with the potential for making a substantive impact on reducing risk and the prevalence of adverse events. In order to understand how the health sector can achieve similar results in clinical environments, we first define the concept of “visibility” and explain how it contributes to achieving safer healthcare systems. What Do We Mean by Visibility in Healthcare? For the purposes of this paper, visibility—the ability to be seen or known—is the strategic outcome of implementing supply chain tools and practices that create the ability to see the processes, products and procedures associated with healthcare services that are linked to key patient outcomes, including safety, health and wellness, and health system performance and value. Visibility in clinical environments means that system stakeholders can track and trace the care patients receive, the products used to deliver care, the health outcomes that care achieves for patients, the potential risks patients may face that provider teams can manage and mitigate, and the value of patient care procedures. The endgame of visibility is to achieve the ultimate goal of care that is transparent and accountable, and that achieves value for patients. The sequence of these many and varied processes in healthcare represents the health sector supply chain. Visibility is a key feature of a supply chain that reveals every step of the process, from the manufacture of a product, through its use in clinical care processes, through tracking outcomes of care for patients, including health and quality of life. Visibility in healthcare systems ensures that care is not only accurate, but also improves the health of patients and populations. Digital tools that are embedded in clinical environments can track and trace every product and care process to create this transparency and visibility in the health system. These tools not only monitor and track patient outcomes, but also link those outcomes to the use of products, processes and procedures, contributing to safety and quality across health systems. Further, at the system level, the tools enable health organizations to link outcomes to an accurate accounting of resource allocation (for example, the cost of products, processes and procedures). Such linkage can more directly determine the value of care processes relative to the use of resources required to deliver care. Visibility in healthcare systems is a fundamental feature of full accountability for the value proposition that healthcare delivers to populations.

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Visibility and Supply Chain Processes in Healthcare Systems In healthcare, “supply chain” refers to the information, supplies and finances involved with the acquisition and movement of goods and services from the supplier to the end user in order to enhance clinical outcomes while controlling costs.40 Visibility is a key characteristic of a highly effective supply chain. A robust supply chain system that is highly visible tracks every product, every patient and every process in healthcare digitally and intuitively, requiring little effort on the part of clinicians. This makes the entire continuum of care transparent and “visible” for all stakeholders—most importantly, patients and provider teams. Supply chain processes in clinical environments have the same potential for impact that seat belt buzzers had for vehicle occupants, and that public policy bans on smoking in public places had for smokers. In most other industry sectors that offer services and products to the public, supply chain processes are embedded into the environments in which these systems operate, creating visibility across the entire value chain of services. A fully accountable and visible supply chain in healthcare would similarly inform and illustrate where and how safety can be improved across the continuum of care services. The grocery industry, for example, tracks and traces every food item from the producer (farm) to the end consumer to ensure that safety and traceability are highly visible, in the event that any food item be contaminated or any product be found unsafe for consumers. In the airline industry, every passenger is tracked and traced from the time they check in to the time they take their assigned seat on an aircraft and disembark from the airport. Such automated supply chain infrastructure and use of tracking tools are key characteristics that are readily translatable to clinical environments in health systems.

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The Key Features of a Highly Visible Healthcare System Where to Begin? Current Features of the Health System Supply Chain Healthcare is a highly complex system that delivers a wide range of specialized, knowledge-intensive services to patients (Figure 5). In order to deliver this wide range of services, healthcare systems procure tens of thousands of products, from medications to devices and consumables, that are used in hundreds of different services and procedures for patient care delivery. For example, there are often over 10,000 implant products in use in North American health systems that are all designed for essentially the same purpose.1 In over 20 other industry sectors, other than healthcare, automated supply chain processes are in place that use global standards to identify products accurately and identify key attributes of the product, including the manufacturer, the ingredients, when the product was manufactured, when it was received, and when and where it was used or purchased by the end user. Figure 5: Complexity of Current Health System Supply Chain

(Source: Cardinal Health Inc., 2016)

However, the health sector remains unable to track and trace products used in care processes across health system environments owing to the inability to identify products using global product identification (GS1) standards. There are no government policy frameworks in Canada that require adoption of global standards (GS1) to guide supply processes or to support alignment with global jurisdictions. This 20


presents challenges in managing inventory and procurement and offers no ability to track product details as products move from manufacturer to patient bedsides. Thus, hospitals and most clinical facilities cannot track or trace the medications, joint implants, pacemakers or any other products that patients receive during treatments or surgical procedures without standardized identification across the supply chain processes. All pharmaceutical companies, retail pharmacies and distributors of products have already adopted GS1 product identification standards years ago. Yet pharmaceutical products still cannot be tracked or traced to individual patients in the majority of healthcare settings because health systems have not yet adopted global standards and have not yet integrated the barcode-scanning tools into clinical environments to achieve traceability. Thus, in most organizations in global health systems, there remains almost no ability to identify which individual patients received which products in the event of a recall due to product failure. Inventory management processes are largely manual and paper-based, making it challenging to align the demands for products and technologies with population health needs and demands for care. Manual inventory and supply chain processes are well documented to be associated with high inventory costs, frequent shortages of products and stock-outs, as manufacturers have limited ability to predict and manage surge demand for specific products.41 Further, many health organizations in Canada and the US rely on group purchasing organizations (GPOs), which offer some level of supply chain integration and automation, but only to the loading dock of the health organization, most often hospitals. We could find no health system that has adopted global product identification standards that offer complete tracking and traceability across the supply chain right to the individual patient level across the continuum of care. Figure 6 maps the typical supply chain processes currently operating (at a cursory level) in hospitals. To date, no pathways have been described that map how supply chain processes operate in community-based health organizations. Figure 6: Current Supply Chain Processes in Hospitals

(Source: Cardinal Health Inc., 2016)

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As Figure 6 illustrates, supply chain processes are primarily manual and involved in the ordering and delivery of products to clinical units for use in care services. They primarily use paper-based systems to track inventory. This process comprises five steps: 1. Health professionals or procurement teams order products from suppliers—GPOs, single sign-ons (SSOs) or directly from manufacturers. Standardization and product bulk purchases are used where possible to get a better price and achieve cost savings. Procurement processes vary widely, as does clinician involvement in the management of product procurement. 2. Distributors manage the delivery of some (not all) pharmaceutical products, devices and consumables to health organizations. Barcodes are often placed on products by distributors or hospitals using proprietary information technology (IT) systems, precluding the ability to trace products from manufacturers to patients. As a result, there is little standardization across organizations to identify and track product use or patient outcomes. 3. Product inventory (for example, medications, supplies, devices) in hospitals is plagued by either shortages or overstocking caused by clinical unit “hoarding,� requiring staff to search for supplies. The use of manual inventory management of products results in frequent lapses of expiry dates and discarded product. Consignment products cannot be tracked or identified in most hospital settings. 4. Products and supplies are distributed to clinical units, usually on carts where products are arranged in drawers and shelves to supply patient care on each clinical unit. Staff take products from the cart as they are needed for patient care. When carts run out of stock, staff look for stock carts on other units to locate what they need. There is no tracking or accounting of which products are used for which patients; therefore, no accurate case costing or tracking of products is possible for each patient care transaction. 5. Patient care procedures are conducted with either no record of product use, or with handwritten/transcribed notes of product use for implanted devices, recorded in operative reports or progress notes by the surgical team. In the majority of organizations, no information on product content, attributes, lot number, batch number or expiry data is captured in clinical settings because there is no unique device or product identification (UDI) number used across the health supply chain to enable the identification and tracking of health products. The exception, in part, is the use of blood products and human tissue products in health systems. The blood services organizations have developed a supply chain strategy that can track and trace every donor and every blood or tissue product across the health system to identify the products that are used in each health organization. Even so, tracking remains limited because clinical organizations do not track patient outcomes of the use of blood or tissue products at the individual patient level. Although blood service organizations do not use the global standards for identification, they have a global consortium and agreement with GS1 standards organizations worldwide that could link the tracking and traceability of blood and tissue products in health systems, should advances in supply chain be realized. Once the product is delivered to hospital receiving departments, there is no system that enables clinicians or organizations to track and trace which product was used for which patient, in which 22


procedure, by which clinical team, and linked to patient outcomes. Inventory of products in clinical settings is managed by a wide range of people, including nurses on clinical units, physicians in some specialty units (for example, the cardiac catheterization lab) and inventory or procurement teams. Products are stored in a variety of settings on clinical units; there is no centralized record or tracking of product use (for example, devices, medications and consumables), or of patient care procedures linked to patient outcomes. There are some rare exceptions to this supply chain process. Only 6% of Canadian hospitals have been identified as tracking and tracing medications from the manufacturer to the point of care, linking medications to individual patients. This figure contrasts with 50% of hospitals in the US that track and trace medications to the point of care administration to ensure right medication, right patient, and right route, time and dose.42 The limitation of the US system is the inability to track and trace the use of products across organizations or across the continuum of care. One Canadian hospital that has implemented barcode scanning for medication administration has achieved a 90% reduction of errors involving the wrong medication administered to the wrong patient, and an overall 40% reduction in medication errors.43 The value of visibility in healthcare systems may be the catalyst for innovation and transformation that can overcome the relentless patient safety challenges, and the growing cost pressures, that all healthcare systems currently face. The next section maps out what a highly visible supply chain could achieve for patient safety and health system performance and accountability.

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Creating a Highly Visible Supply Chain in Healthcare Systems Supply chain processes in healthcare systems achieve two fundamentally important outcomes at the health system level: quality outcomes and cost savings. Both are centrally important to the sustainability of healthcare systems. Quality outcomes include patient safety outcomes, which carry substantial cost impact. Cost savings, primarily labour and inventory costs, as well as cost/case transparency, are readily achieved when supply chain tracking and tracing are implemented. Patient safety efforts to date have focused on raising awareness of patient safety in clinical settings, rather than creating clinical tools to reduce or prevent adverse events. The tools that create visibility for patients, the processes they experience and the outcomes that care processes achieve are critical to prevent tens of thousands of patients and their families from suffering the consequences of a health system that leaves safety to the best efforts of clinical teams that use antiquated adverse event reports. The key features of a fully visible, safe and effective health system are described in the following section. Figure 7: Key Features of a Highly Visible Healthcare System Safe Clinical Environments Adverse drug events tracked to product use, practitioner practice Costing of admissions accurate, tracked to determine value Manufacturers access product data and performance to support innovation

Patient Outcomes/Recall Patient outcomes and product performance tracked; consumers have product record for recalls and reporting outcomes

Policy Adoption of Global GS1 standards (required) E-Commerce Automated ordering using GS1 standards, automated inventory management to reduce stock-outs, manage demand, track inventory, reduce waste Consumers Have a record of care processes and product information

Tracking Traceability of product, procedure, provider, location to patient outcomes to alert clinicians to reduce adverse events

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Figure 7 illustrates the key features of a highly visible healthcare system, characterized by embedded tools that track and trace every process in the supply chain. The first step towards creating such a system relies on the leadership of policy makers to create the policy framework necessary to achieve visibility, namely, the adoption of global standards (GS1 barcoding) to identify products, patients and care processes linked to patient outcomes that offer complete visibility across the entire continuum of care. A highly visible healthcare system would create clinical environments that reduce the likelihood of adverse events by leveraging tools that track and notify clinician teams of the risk of error, so that risk can be effectively managed to protect patients. Such a system would also enable accountability for managing risk, informed by the near real-time reporting and analysis of digital adverse event alerts and clinical team interventions to manage risk. It would be characterized by a clinical environment where clinicians, provider teams, patients and their families have access to tracking and tracing reports (visibility) of all products, procedures and processes to inform decisions on the best available care processes that offer patients the best outcomes. Healthcare settings would have the infrastructure tools built right into the work environment. The tools would perform “double-checks” for accuracy and effectiveness of care processes, automating the tracking of the products or devices that patients receive during their treatments or procedures. London Health Sciences Centre: A Highly Visible Health System for Medication Administration London Health Sciences Centre created a visibility strategy for the purpose of reducing the risk of harm to patients related to medication errors. The organization adopted GS1 standards and implemented the following:  Computerized physician order entry software that captures medication orders for every patient  Linking of physician orders to a digital medication record system to ensure the medication ordered is the one that is correctly administered  Barcoding and scanning of all medications using unique identification numbers (GSRN) for all patients and all medications (GTIN) to track accuracy of medication to prevent risk of error  Digital medication reconciliation software to analyze medications administered to generate weekly reports of errors, identify root causes of errors, and generate reports for leaders and clinicians to identify patterns of medication errors across the organization Every medication and every patient ID band is scanned to identify whether the medication being given is correct, based on the physician’s order, for the patient, including right time, dose, route and patient. If the scan fails, it alerts the nurse to the failure and identifies the source of error (for example, dose, route, time, medication). The nurse can override the system and administer the medication, but must complete three extra steps to do so, thus generating the details of the override to justify the rationale for doing so. Weekly reports of scanning errors are generated across the organization to support provider accountability for practice decisions and patient outcomes of each event. The hospital was able to scale this initiative across 10 community hospital partners to achieve a transformation strategy across the entire region. The total investment to achieve this success was $30 million for all 11 sites. 25


These automated tools enable accuracy and visibility across all components of the supply chain management process. For e-commerce processes, products are automatically reordered as they are used to ensure that stock-outs never happen and accuracy in product demand is captured, measured and reported. Tracking tools are embedded in clinical environments in a way that they are so intuitive that clinical teams use them as a routine part of care, with no need to manually check every step of care processes. All this can be accomplished by changing existing environments so that care cannot happen unless the tracking and tracing tools are engaged. Data analytics offer the opportunity for analyzing organizational progress towards quality and safety goals, as well as accounting for clinician interventions to ensure safe care. The tools are also intuitively embedded in care processes to streamline the complex nature of healthcare environments, tracking and tracing patients, providers and processes automatically to support and inform accountable care models of service delivery. Highly visible healthcare systems enable access to the patient record by providers when granted permission to do so by patients, who can use their own record of care to know exactly what care has been received, from whom it has been received, and what was achieved in terms of outcomes. Such details can inform patient and provider decisions in future phases of care. This high visibility of processes, products and patient outcomes essentially removes the unknown for clinicians, enabling an understanding of what has been offered to patients, the results that were achieved, the products that were used, whether or not a procedure offered value, and the long-term outcomes that were realized. Such a visible system would also enable development of built-in algorithms to support best practice and evidence-based clinical decisions. For example, consider the patient described in the following patient story. Helena Lambert’s Story Helena Lambert was prescribed 12 different medications for a variety of medical conditions. Mrs. Lambert was then also prescribed allopurinol for a gout diagnosis. She developed complications that led to her immune system shutting down, and eventually her death. It was subsequently concluded that the interaction between allopurinol and another one of her medications, mercaptopurine, was to blame. A physician at the hospital later said: “This should never have occurred; it was 100 per cent preventable.”75

Imagine the visibility in a health system that is supported and enabled by algorithms to detect and prevent such a catastrophic drug interaction that resulted in Helena Lambert’s death. As a patient presents with a complex record of interventions, built-in algorithms would notify patients that specific medications must never be taken with other medications. In highly visible systems, the software uses the barcodes to link not only the physician orders but also the laboratory results and medication reconciliation of orders to prevent tragedies such as the one described in the example above. A visible system would alert the pharmacist to ensure that such a toxic combination of medications could not be dispensed. Further, it would alert the physician or provider team of the potential for toxicity among the 12 different medications at the time they were prescribed. These types of alerts occur far too infrequently in current healthcare systems. What is needed is a system of tracking and tracing individual patient care processes (for example, medication prescriptions) across the continuum of care that engages multiple provider teams and many distinct clinical settings. 26


This degree of visibility—where there are built-in checks and balances to prevent events such as catastrophic drug interactions—could be the single most important feature of a visible health system that protects patients from completely preventable never events. Should an error occur, information would be automatically communicated across health teams, organizations and systems to enable clinicians to rescue patients from high-risk situations to ensure that the “never event” would not happen a second time. An example of such a system comes from the aviation industry: “The starkest counterpoint to health care’s lack of transparency around error … is offered by the aviation industry. On the way to dramatically improving the safety of flying, the sector has become conspicuously open about its mishaps. Canada’s Transportation Safety Board, for instance, posts details online of current investigations into everything from actual crashes to ground vehicles inadvertently driving across airport runways. The constant, transparent exchange of safety information not only helps curb accidents, but enhances passengers’ confidence in the industry,” —John Pottinger, an aviation-safety consultant and former Transport Canada official.44 The very same “transparent exchange” of information could be achieved in healthcare by redesigning the clinical environment to be equipped with the tools for tracking, tracing and reporting at the individual patient and product level, enabling comprehensive analysis and communication of preventable events to every clinical team in the system. In the US, hospitals are notified by the FDA of product recalls; however, disseminating this information frequently requires patient chart review to identify which patients received the specific product in question, usually with only the lot number of the product to identify its class, with no indication of the product serial number to identify specific products received by individual patients. Recall notices or notifications could also be disseminated across the system, where the circumstances of a preventable event in one organization are communicated to all relevant organizations to ensure that risks to similar patients are mitigated. Patient safety tools that enable clinician teams to deliver safe and effective care include automated reporting, alerts of potential adverse event situations and system-wide reporting to support learning and prevention. The essential requirements of the future visible healthcare system include the following five conditions. 1.

Adoption of GS1 Standards as the Global Language of Supply Chain in Healthcare Systems

The first and most critical step towards a highly visible healthcare system is creating the policy framework requiring every product and process in healthcare to use global standards that identify products used in care delivery and link them to patients who receive care and to providers who deliver it. Over 20 industry sectors globally have adopted these standards, developed and implemented by a worldwide network of GS1 organizations, currently operating in 114 countries. Every grocery item, every retail item and every pharmaceutical product currently use GS1 standards for identifying products accurately, tracking and tracing their movement from manufacturer and supplier to the organizations that purchase them. Leadership among policy makers is critical to implement regulatory frameworks that require adoption of GS1 standards for all products used in healthcare systems in Canada and

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worldwide. GS1 standards are the only global product-identifying system common to 114 countries in the world. The standards essentially create a common language that every health system stakeholder knows and uses to identify products, order and ship them to ensure they are available when and where they are needed, and then track products and their use at the point of patient care. A number of product manufacturers have already adopted GS1 standards, and a number of retail organizations, such as pharmacies, already use fully automated systems for traceability of pharmaceutical products to individual consumers. Yet the same capability has not been achieved in hospital pharmacies owing to the lack of policy mandates governing health systems. Once policy makers establish this requirement, healthcare organizations can leverage the many GS1-compliant barcodes to encode critical supply chain and clinical information, standardized to be read in any healthcare setting worldwide, to establish visibility in healthcare systems. Adoption of GS1 standards enables the use of barcodes, allowing for a rich set of data to be encoded and then tracked in any health organization in any of the 114 countries in the world. Data tracked in GS1 barcodes of products includes product lot number, expiry date, serial number and shipping locations, which are then linked to unique identification of patients and individual providers who are assigned a Global Service Relationship Number (GSRN). For example, when a doctor prescribes a medication to a patient, the medication is dispensed by a pharmacist; a GSRN identifies the doctor and another GSRN identifies the pharmacist who filled the prescription, which is then linked to the patient, who has their own unique GSRN. The medication has a global trade identification number (GTIN) that identifies the key attributes of the product to inform and ensure clinical teams and providers that they have the product information they need to make decisions. Unless and until policy frameworks governing healthcare systems require the adoption of GS1 standards for every product and clinical care process in healthcare systems, the value of global standards will not be realized. Canada is one of the few OECD countries to have made little progress in developing the policy required to ensure that GS1 standards are adopted in healthcare systems. British Columbia and Alberta have made progress in advancing supply chain tracking and traceability in specific clinical settings such as the operating room suite, or for specific classifications of products such as medical devices. Australia has adopted GS1 standards nationally, requiring every state to adopt these standards in healthcare. In addition, Australia has created a national organization, the Australian Digital Health Agency (formerly the National E-Health Transition Authority [NEHTA]) as an authority to “develop better ways of electronically collecting and securely exchanging health information.�45 These steps provide a framework to guide and stimulate the implementation of comprehensive tracking, traceability and reporting in clinical environments across the entire Australian health system. Ireland is another country that has made substantial progress in tracking and tracing products and care from manufacturer to the home setting, whereby patients self-administer medication to manage haemophilia. Figure 8 illustrates the traceability and tracking process implemented by St. James’s hospital in Dublin.46 What is impressive in the Ireland case is the use of smartphone technology: patients simply take a picture of the medication barcode and upload it, so that the product can be 28


tracked and traced from the manufacturer right to patients’ use of it in their own homes. Figure 8 describes the supply chain pathway engaging patients directly in tracking their own care. Figure 8: Community Traceability of Patient Care

The Solutions Unique product barcoding

Home/Hospital tracking

Patient

Electronic patient record

“Interestingly, when the entire healthcare system works with patients to deliver and track the supply chain of services for wellness, healthcare savings and improved patient outcomes can be achieved. More than a just a vision of the future, this is being achieved with suppliers, hospitals and patients in Ireland.” —Feargal McGroarty, Project Manager, National Centre for Hereditary Coagulation Disorders, St. James’s Hospital, Dublin, Ireland76

Validated cold chain delivery

The US has made progress in policy support for visibility in healthcare systems. The Food and Drug Administration (FDA), the national body that regulates all food and drug approvals, has mandated that all health products (devices, drugs and consumables) must use GS1 or HIBCC (for devices) for product identification to ensure that accuracy of product features and attributes are communicated for all stakeholders in healthcare systems.47,48 Similarly, the largest publicly funded sector of the US healthcare system is considering mandating the use of global product standards (GS1 or HBICC) for all claims submissions made to Medicare and Medicaid to include the unique product identification number in order for the claim to be considered for reimbursement. In combination, these two policies essentially mandate the adoption of GS1 standards by every manufacturer in the US marketplace. More importantly, they require that health system organizations, such as hospitals, use the GS1 and HBICC identification numbers to process reimbursement claims. This proactive policy leadership sets the stage for a highly visible healthcare system in the US, one that will now be able to track and trace every product from manufacturer to patient (based on claims information) in the Medicare and Medicaid systems.

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The European Union is poised to implement a policy requiring the adoption of GS1 standards for all health products procured across its healthcare systems. The NHS in the UK has already moved to incorporate GS1 standards and is implementing the fully visible health system in a number of NHS trusts. One of the NHS leaders, Lorna Wilkinson (Director of Nursing, Salisbury NHS Foundation Trust), describes the impact the adoption of GS1 standards is expected to have in the UK health system: “When implemented, the standards will enable clarity of the full patient journey including what clinical procedures have been performed, what equipment is being used, which devices are implanted, what medication is being administered and by whom and all of this will be recorded in a comprehensive electronic patient record.”49 Evidence of the impact of adoption of GS1 standards in healthcare is mounting. Leaders in Australia, the US and the UK identify the policy-mandated adoption of GS1 standards to support traceability as the critical first important step required to achieve visibility in healthcare systems. The adoption of GS1 standards would mean that clinical environments have the infrastructure necessary to achieve visibility. In order for this to occur, implementation of the following is required:  

Global Tracking Identification Number (GTIN): All product packaging would have a GTIN that uniquely identifies the product and its attributes. Unique patient identification with a Global Service Relationship Number (GSRN) to identify the patient: Every product (GTIN) is scanned followed by every patient armband (GSRN) and medical record so that every product is linked to every patient to determine outcomes, and safety alerts can be integrated into clinical environments. Clinician identification: Clinicians are identified by their unique GSRN to link each provider participating in care processes to each patient in each clinical setting. This supports tracking and tracing of care delivery and prevalence of adverse events across organizations and across health systems. Automation of tracking and reporting enables clinicians to be notified of adverse events or product performance outcomes and helps them to create strategies to prevent future adverse events for their patients. Global Location Identification Number (GLIN) assigned to every clinical setting: Each clinical setting receives a unique barcoded location number. Coupled with the product GTIN and patient and provider GSRNs, the GLIN makes it possible to identify every patient and provider team in every clinical setting (hospital, community, home, long-term care) where care is received, as well as the products used for each individual patient.

The adoption of GS1 standards allows a common global language to be used across every healthcare setting in every health system in the world. This means that a patient and family can travel anywhere and be able to identify or have access to their health record, the products used in their care processes and the details of their healthcare transactions. Imagine a person travelling to London, England for a holiday. They experience a fall, fracturing their hip in a joint that was replaced in Toronto the previous year. If GS1 standards were adopted in the Ontario health system, the patient would be able to readily open their patient record product barcode information on a smartphone, identify the implant placed in their hip in Toronto and then share that information with surgeons in the UK to inform decisions on the 30


best course of action. This system has been demonstrated in Ireland to be effective for use of products in the home, tracked and traced by patients who can access their patient records in the health system. Leadership to create the policy environment mandating the adoption of GS1 standards in all healthcare systems in a country is the first critical step towards a visible health system. Although GS1 standards adoption is foundational to a highly visible healthcare system, adoption is only the first step; many additional system-level supports are required. 2.

e-Commerce Processes That Automate Supply Chain in Healthcare Systems

Supply chain processes manage the movement of products from manufacturers and distributors to clinical settings in every organization that delivers healthcare. Not only is the healthcare system complex, but it relies on the availability of a very large number of products that are needed by clinicians when and where they are required to deliver care. One health leader in Canada identified that approximately 60,000 products are procured, distributed and stored until needed in health settings in one Canadian province (Jitendra Prasad, Alberta Health Services, personal communication, 2016). These processes are enabled and transformed when a single product identification standard (for example, GS1 barcodes) are mandated and implemented across the supply chain in healthcare systems. The following elements of e-commerce are the integral “back office” infrastructure that automates the movement of products into clinical settings, ensuring each product is identified accurately, including required attributes (product features such as “latex” or “single use”) that must be known or visible to clinician teams to ensure the right product is used for each patient to achieve the best outcome: 

Inventory management using digitized product identification barcodes enables healthcare systems to ensure that minimal product inventory is maintained yet products are available when needed. Product costs in healthcare systems are very high. With automated indexing of inventory using both product identification barcodes (GTIN) and product location barcodes (GLIN), products can be maintained in inventory based on evidence of demand. Currently, clinicians and procurement specialists order products based on what they believe is needed, with no objective or accurate data describing product demand to inform decisions on inventory. The result of this manual system of ordering and storing products is inventory that clinicians cannot locate, and high levels of waste of products that are purchased and then discarded when expiry dates are exceeded. With good management, inventory is based on accurate product demand, expiry dates are monitored to ensure products are used within product expiry time frames, product attributes are available to ensure the right product is used for the right patient, and inventory visibility (what products are in stock and available) is managed accurately to avoid shortages or stock-outs. Inventory carries only the product volumes that are needed, overcoming the highly expensive manual system of ordering “what we think we need.” e-Commerce processes are similarly automated, meaning that every time a product is removed from inventory and used for patient care, it is scanned and automatically replenished. There is no labour cost of replenishment in highly visible healthcare systems 31


because purchase orders are automatically generated when the product is used. This approach further enables tracking based on product use, rather than estimates of product use. Automated replenishment also informs product demand over time and enables healthcare systems to avoid stock-outs or shortages of critical products such as narcotics. Visibility of inventory to suppliers would permit identification of risks of shortages and the opportunity to strategize to overcome them, eliminating the need for emergency orders by fax or telephone when inventory has not been clearly linked to product demand. If clinical demands and inventory were fully visible to suppliers, procurement decisions and agreements could include, and reward, risk mitigation strategies and contingency planning to reduce or eliminate the risk of stock-outs. Visibility enables and informs accountability across all stakeholders in healthcare to ensure that products are safe and available when and where they are required to support patient care. Procurement processes: In a visible system, product identification is highly accurate, given that each and every product can be readily identified using automated online tools for procurement directly from distributors or manufacturers. When products are easily and accurately identified, pricing becomes more visible and group purchasing contracts can be more readily implemented based on objective product tracking data to inform product value (cost of product relative to patient outcomes achieved). This helps to achieve cost savings through bulk purchasing opportunities. Provinces in Canada that have consolidated product procurement processes have reduced product costs by as much as 80% (Snowdon, et al, in press), a substantial cost savings for healthcare systems if scaled across jurisdictions. Accurately identifying products enables automated ordering and procurement to support “lean” inventory management, facilitated by accurate planning, evidence of value and automated product inventory management. Accurate case costing: Automated inventory management and e-commerce processes enable organizations such as hospitals to track and trace every product to every patient, process, procedure, and location (e.g., operating room, emergency department, patient room). Consider the large number of surgeons in a hospital, all of whom have varied preferences and routines in surgical cases. An automated supply chain that identifies exactly what products are used during individual procedures for every patient permits exact case costing of every surgical procedure. Patterns of product use in surgery enable comparison across surgeons and across procedures to determine variability in product use and practice routines. This approach offers more objective evidence to support opportunities for standardization with less variability and greater value. In the US, this concept is referred to as “activity-based costing,” and it is increasingly applied in healthcare settings after many years of debate and discussion. Tracking every product in every care process or procedure for each patient creates an entirely new visibility of health system costs for health organizations. When products can be scanned and linked to patients, the true value of products, in terms of usability and patient outcomes, can be determined.

By using automated e-commerce tools in healthcare, we can build automated inventory management based on patient care volumes and product demand. This will reduce the risk of waste due to expired dates, enable tracking of utilization volumes and organize replenishment to minimize inventory costs while at the same time ensuring that a product is available when and where it is required.41 32


3.

Automated Tracking, Traceability and Reporting of Products, Processes and Patient Outcomes

Perhaps the most important opportunity in a highly visible system is the implementation of clinical safety tools to track and report the processes, procedures and products allocated to each individual patient to evaluate safety and effectiveness of care outcomes. Despite the introduction of strategies such as provider education, surgical checklists and greater supervision of care processes, these have had limited system-level impact on safety outcomes for patients. Supply chain transformation offers the opportunity for embedding tools into the clinical environment that reduce the risk of errors and adverse events. Automated barcode scanning offers an alert system for provider teams that identifies the wrong medication before it is given to the patient and alerts the provider that the medication barcode and the patient ID barcode are incompatible. Such a system generates regular reporting and analysis of the frequency and type of barcoding failures that indicate medication adverse events across entire health systems. In the highly visible clinical environment, every sponge would be scanned so that it was counted and linked automatically to the patient, the operating room and the provider team. The sponge would be scanned by the circulating nurse when the product was being opened and placed in the sterile field for use during surgery. Just as a grocery store clerk scans every item and the item appears on the monitor for both the cashier and the customer to see, so too would all surgical products be scanned and displayed for the clinical team to view the list of products opened and placed on surgical trays during the procedure. The visual representation of the scanned product list offers two opportunities: (a) the complete listing of items to account for, ensuring that no foreign body is left in the surgical cavity, and (b) an accounting of product use for each surgical patient to provide an accurate case costing. Joint implants, stents and all other products used for or inserted into a surgical wound would be fully accounted for, along with detailed product attributes such as presence of latex, metal and so on, linked to patient health records. Transparency for patients is further enabled when they are provided with an accurate list of products as a personal record in the event of a product recall or failure, or to inform future care decisions with provider teams. This fully visible and transparent system enables total accountability for products and processes used in all clinical settings. 4.

Traceability of Product Outcomes, Product Notification and Recall

One of the most important features of a fully automated supply chain system in healthcare is the opportunity it offers in terms of managing and identifying possible risks for patients. As an example, a recent horsemeat scandal in the UK food supply was a challenge for the UK health system.50 Given the standardization and automation of the grocery supply chain, the grocery sector was readily able to identify all horsemeat products on store shelves. This enabled tracking of the meat products right back to the farm, the plants that processed them and their distribution to the retail stores that sold them. UK health organizations, however, were unable to achieve the same tracking of product in clinical settings.

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The volume of product recalls and adverse events that require action are estimated by one health system in Canada to be 7,000 notifications per year (Jitendra Prasad, Alberta Health Systems, personal communication, 2016). Health Canada and product manufacturers are estimated to send out 3,500 notifications annually reporting product failures or product warnings (Prasad, personal communication, 2016). For every notification, health system stakeholders must identify the patients who received the product and the outcomes that were experienced by manually reviewing patient records. In an automated system, the identification of patients who received the product in question could be conducted in a matter of a few hours. Moreover, the automated process of tracking and tracing such events or product notifications would require very minimal labour to complete the investigation. Standardized and automated traceability offers a further opportunity that is critically important for achieving a visible health system. Automated traceability creates “extreme transparency” for healthcare systems by enabling safety information to be reported and made available to system stakeholders and the public for analysis and learning. When adverse events occur, disseminating what happened (that is, the root cause) and, more importantly, how the event can be averted or prevented, is a key strategy that visibility achieves in healthcare systems. The sharing of information and resultant analysis between clinical units within hospitals, across hospital networks and community care providers and healthcare stakeholders globally, creates the visible platform for learning and risk mitigation strategies for all patients and potential patients. In both the UK and Australia, national registries exist for specific products such as orthopaedic implants. These registries track patient outcomes of these products, alerting health systems of product outcomes and patient safety risks.26 North American health systems rely heavily on these registries for identifying such risks26 because there is no similar system in North America. Darrell Horn is a critical-incident lead investigator with years of experience at the Winnipeg Region Health Authority. He investigates adverse events across Canada. Based on his extensive experience, he has suggested that “releasing descriptions of incidents and lessons learned from them would be the most effective way to educate health-care workers.”44 Automated reporting of events and recalls, linked to patient outcomes, is a key feature of a highly visible health system. Such systems not only advise the public of progress towards safer healthcare, but also inform and enable clinicians, teams and organizations to quickly identify patterns and prevent adverse events. As well, they proactively protect patients from harm and effectively disseminate information across healthcare systems to further mitigate risk. An automated recall and tracking system not only provides system-wide analysis of adverse events; it also provides automated feedback for clinical teams, who can use the information to inform their practice and streamline processes to reduce the risk of error that causes harm to patients. If the proposed system of automated tracking and traceability were applied across health system organizations, adverse events could be substantially reduced, and never events could be all but eliminated. In the London Health Sciences strategy, medication-related adverse events decreased by up to 40% (across 10 hospital sites), and never events decreased by 90% (Robin Walker, MD, personal communication, 2016). When the proposed features of high-visibility healthcare systems are applied to the top 15 never events, all but one could potentially be prevented simply by implementing a highly visible tool in clinical environments. Table 2 identifies the strategy for eliminating never events using 34


the supply chain strategies described above. These systems would also provide visibility to industry, where healthcare safety data and know-how are required for the design of safer products. Table 2: How System Visibility Could Eliminate Never Events Never Events

How Tracking and Tracing Could Eliminate Never Events

1. Surgery on the wrong body part or the wrong patient, or conducting wrong procedure 2. Wrong tissue, biological implant or blood product given to a patient 3. Unintended foreign object left in a patient following a procedure

Tracking individual patients and correct surgical procedures that match chart and consent using barcodes to link procedure to patient armband. Barcoded tissue or implant scanned to patient chart for automated tracking for recalls and evaluating outcomes.

Every product is scanned in each operating room to reconcile product count and use during every surgery, using GTINs for product identification and GLINs to identify location of operating room where product was used. 4. Patient death or serious harm arising Tracking of sterile/nonsterile product(s) to patient. Barcode identification to determine sterile/nonsterile product attribute based from the use of improperly sterilized instruments or equipment provided by on accurate GTIN barcode. the healthcare facility 5. Patient death or serious harm due to a Barcode scan of medication to patient barcode to match allergy failure to inquire whether a patient has status of patient to medication content identified with the GTIN; a known allergy to medication, or due scanning barcode alerts the provider to medication allergy status for all medications. to administration of a medication where a patient's allergy had been identified Patient identification band barcode is scanned to inhalation gas 6. Patient death or serious harm due to barcode to alert anaesthetist to correct inhalation for correct patient the administration of the wrong procedure using system algorithms that alert surgical teams to all inhalation or insufflation gas inhalation never events. Correct medication for correct patient can be achieved by scanning 7. Patient death or serious harm as a medication barcode and patient barcode to determine correct result of one of five pharmaceutical match (right drug, right dose, right route, right patient, right time) to events patient record. Barcoded lab results can be linked to patient ID barcode using 8. Patient death or serious harm as a algorithms that alert providers to contraindications for patients who result of failure to identify and treat receive medications matched to lab results, or other medications metabolic disturbances that, when given together, cause significant adverse events. 9. Any stage III or stage IV pressure ulcer Tracking procedures completed by scanning patient barcode with nurse barcode to indicate every time a patient is turned and skin acquired after admission to hospital care is provided to prevent pressure ulcers. 10. Patient death or serious harm due to Barcoded patient armband identifies presence of implanted device(s); barcode on the device identifies metal content of the uncontrolled movement of a device, alerting the provider team to those patients who CANNOT ferromagnetic object in an MRI area risk having an MRI due to the metal content of an implant—eg, hip, knee, defibrillator, pacemaker. 11. Patient death or serious harm due to an accidental burn

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12. Patient under the highest level of observation leaves a secured facility or ward without the knowledge of staff 13. Patient suicide, or attempted suicide that resulted in serious harm, in instances where suicide prevention protocols were to be applied to patients under the highest level of observation 14. Infant abducted, or discharged to the wrong person 15. Patient death or serious harm as a result of transport of a frail patient, or patient with dementia, where protocols were not followed to ensure the patient was left in a safe environment

Barcoded armbands on all patients to track where they are in the healthcare facility using RFID technology, just as airline industry does for passengers. Barcoded tracking of assessment procedures by nurse/provider to assess suicide risk 24/7.

Barcoded patient ID bands that link every infant to the mother’s barcoded patient ID band. Barcoded patient ID bands track location of patients during transport and during hospital admission to monitor location of patient at all times and prevent wandering—eg, tracking patients in ED so that staff can see patient movement and location (such as bathroom) to ensure safety.

Environments with the ability to track and trace patients, products and processes create an alerting system to cue staff, enabling them to prevent an adverse event or an event that should “never” happen. The systematic reporting of all such events, using digital records of care transactions, helps leaders to identify patterns of adverse events and their root causes to inform strategies for prevention and improve organizational accountability. 5.

Measurement Strategy That Captures Strategic Supply Chain Outcomes in Healthcare

Measurement in health systems has been well established for decades. However, measurement has focused primarily on patterns of illness, health system utilization, cost and performance. Unlike in so many other business sectors, we could find no health system measures that reflect supply chain management outcomes. A highly visible healthcare system would enable a robust measurement framework to track progress towards strategic supply chain management. Key metrics that reflect supply chain transformation must include patient care outcomes, such as the prevalence and type of adverse events—for example, medication errors, measured using automated reporting from digital infrastructure, as in the London Health Sciences Centre’s system: product outcome measures such as frequency of shortages, product performance outcomes post-operatively including infection rates, product failure identified across clinical settings and organizations using standardized measures. Health system measures that reflect advanced supply chain management processes would include inventory cost savings, economic impact of adverse events, patient health and recovery time linked to product use and procedure quality and safety, rate of shortages and stock-outs, accurate case costing, and health provider engagement in adverse event reporting and proactive prevention strategies to reduce the rate and severity of adverse events in healthcare. Supply chain process measurement could also inform and support accountability for health services delivery because it would enable leaders to use automated reporting systems, generated in near real time, to understand root causes of adverse events and identify types of clinical settings where patterns 36


of adverse events take place. This would enable clinical teams to design and evaluate risk mitigation and prevention strategies to protect patients. It would also help them to identify best evidence of strategies that achieve the greatest impact for patients, families and populations.

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What Is the Value Proposition of Visibility in Healthcare Systems? Health system stakeholders are multiple and complex. The key to achieving visibility in healthcare systems is to create the ability to “see” the value of healthcare delivery from the multiple, but different, perspectives of each stakeholder group. Healthcare systems are mandated by their respective funders to deliver value to the populations they serve. In order to do so, the value propositions for each stakeholder must be clearly understood before it is possible to comprehend the value that visibility offers healthcare systems. The focus on supply chain transformation in healthcare systems is growing, particularly in Australia, the UK and the US, with emerging attention in some Canadian jurisdictions. The early evidence of impact is impressive in these countries and presents an opportunity for scalability. Yet, in order to scale innovative supply chain transformation, healthcare systems must consider the value proposition for its stakeholder groups. This section highlights the value proposition for each group—patients, clinician and provider teams, health organizations, industry and healthcare systems more broadly. The value propositions for these diverse and highly varied stakeholder groups set the stage for a scalable and transformational supply chain for global healthcare systems. While the word “value” has many definitions, we define the concept of value as “a quality based on a person’s principles or standards, one’s judgment about what is valuable and important in life, and what a person deems important. Values are learned throughout childhood and are often influenced by parents, teachers, religion, social networks, and society more broadly. People’s values are often a function of how they were socialized, both formally in school and informally by family, friends, and communities.”51 Each stakeholder holds unique values and achieves outcomes that map onto their unique value proposition. Value Proposition for Patients and Families Patients and families value safe, effective care that is accessible when and where it is needed, and that contributes to achieving desired outcomes such as quality of life, health and wellness.51 In a highly visible healthcare system, patients wear armbands with unique identification (GSRN) that identifies who they are and links each patient to all the orders and procedures in their patient record. In some instances, Radio Frequency Identification (RFID) technology is used to identify products, particularly for products that are expensive, high-risk or challenging to manage (for example, consignment products). The technology “not only offers tracking capability to locate equipment and people in real time, but also provides efficient and accurate access to medical data for doctors and other health professionals. However, the reality of RFID adoption is far behind expectations.”52 38


All encounters in the healthcare system are tracked, and access to records is readily available for patients and their families so that health information and outcomes can be easily shared with the provider team. The effectiveness of treatments, procedures or medications is tracked and recorded for ease of reference. Following any encounter with clinicians, scheduling and managing follow-up care is automatically tracked and referenced to support decision-making, patient engagement in care planning and patients’ self-management of health conditions. All medications are tracked and linked to patient records and pharmacy data files to ensure that medication effectiveness can be shared with care providers, including alerts for potential medication interactions and allergic responses. Patients and their families are readily able to manage health information using terms they can understand, ensuring that high volumes of information are easily processed and priority information is readily understood and accessible. This high degree of visibility reduces the stress and uncertainty of illness by enabling the sharing of health information that is fully transparent and easily accessed. In a visible system, patients can carry their health information with them to interactions with providers to inform decisions and update progress in managing chronic illness. For many sectors of the population who suffer multiple comorbidities, the accurate tracking of health information is particularly important because these patients are challenged by significant burden related to multiple provider treatments and therapies. There is particular risk relative to multiple prescription drugs, treatments for multiple conditions and hospitalizations, which may be difficult for patients to understand and report to providers when they become ill. In a highly visible health system, all health transactions, events, prescribed therapies and medications are barcoded, linked to the patient’s identification and automatically uploaded into the health record, which is accessible to the patient and family. To date, direct patient involvement in monitoring and tracking their own care specifically in support of patient safety has been fairly limited, tends to be ineffective, and has been criticized for placing the burden of patient safety on patients themselves.53 Yet, if every process, procedure and product were scanned and tracked to each patient record, patients and families could have the tools necessary to accurately and easily track their care processes and the outcomes they are able to achieve using patient portals, which are emerging in a number of health organizations. Trackability hinges on the assurance that these processes, procedures and products are described and coded in the same way across institutions so that the patient is not forced to interpret them. Visibility in healthcare systems not only involves patients more directly without burdening them; it also levels the playing field among individuals with different abilities to advocate for themselves or recount their experiences accurately to provider teams.53 Further, in a visible health system, patient transitions between levels of care (primary, community, acute, rehabilitation and long-term care) are supported by accurate and transparent information to ensure that patients do not “fall through the cracks” or that crucial information is not lost or inaccurate. A fully visible health system also enables public reporting of health system performance, including safety outcomes, accessibility, impact and effectiveness on quality of life, allowing patients to make informed healthcare decisions while promoting improvements in the quality of care.54 In fact, public reporting has been found to improve measures of healthcare performance, in addition to quality measures, over time.55 A highly visible healthcare system can happen only when the clinical settings in which care is provided have the tools embedded in the environment to support clinicians to deliver 39


safe care. Consider how the following case study might have had a different outcome had the necessary tools been in place to scan products and patient information. Case Study: Gallbladder Surgery

Following gallbladder removal surgery at 33 years of age, Kapka Petrov did not feel “right.” She noticed that her recovery was not comparable to that of the other patients she was seeing. She was not able to move and felt a “heavy” sensation at the site of the surgery. Petrov was reassured by her nurses that the pain was normal post-operative pain. Upon further consultation with her surgeon she was told that due to the surgery there was some haemorrhaging in the liver as a result of severe inflammation in the gallbladder. She was told that she would be fine. Petrov’s condition continued to deteriorate, with worsening pain and vomiting. She had more surgery to remove any stones that may have been left behind. Although her pain continued, she was assured that it had nothing to do with the surgery. Visit after visit, she was told that it was a “pain management issue” and that there was nothing wrong, despite having to be prescribed morphine and nausea medication. An MRI did not reveal any problems, yet Petrov could not perform basic daily functions on her own. She deteriorated so much that she thought she was dying. She flew home to her parents in Bulgaria, where she spent some time in a hospital being evaluated by specialists. In Bulgaria, it was discovered that a surgical medical clip had been left inside her abdomen from her first surgery in Toronto. The clip remained undetected during all her testing in Toronto; however, it had been clamped onto a nerve in her liver, the ganglion, an artery and a remnant cystic duct, causing her severe pain.77 “Bulgaria might not be most people’s first choice for medical salvation but that eulogy lying on the table, and the three plane tickets beside it, bore witness to just how badly the Canadian health care system had failed this particular woman”77 Among all OECD countries, Canada has the highest rate of error related to a foreign body being left in a surgical site. Retained sponges are a serious problem in surgery or procedure rooms. Despite years of increased awareness and thorough counting protocols, surgical sponges are still unintentionally left inside patients after the wound is closed; almost 90% of retained objects occur when the manual sponge count is thought to be correct.56 Visually searching for missing sponges lengthens procedure time, increases the risk of infection and exposes the patient to prolonged anaesthesia. Miscounts occur in one out of every 150 procedures.56 The average added OR time per miscount: 18 minutes56,57 at an average cost of $62 per minute58 and an average cost of an X-ray to address sponge miscounts: $286 to $705.56 By contrast, in a highly visible health system, the surgical team would scan every product package (every clip, sponge and suture) to the patient’s ID barcode as the package was opened and placed in the sterile field for use by the surgeon. As the barcode was scanned, the item would automatically appear on a monitor in the operating room so that the entire team could see the list of products that must be accounted for before closing the surgical site. The visual list of products on the screen employs the same technology used in every grocery store and pharmacy on a daily basis that itemizes for the seller and the consumer every product that has been scanned. In Kapka Petrov’s case, the team could have easily reconciled the product count, and the surgeon would have known immediately that the clip was missing. This discovery would have cued the team to 40


use an intraoperative X-ray or optics device to remove the clip left in the surgical site. A visible system prevents patients such as Petrov from having to endure months of pain and confusion, not to mention the additional costs to the healthcare system. The technologies to support tracking and traceability in health settings are commercially available, yet are currently integrated in very few settings we could identify. The challenge in bringing them to clinical settings is not the design of such technologies, but getting health systems to adopt them as part of a supply chain strategy across health systems to achieve value for patients. As a result, industry today has little visibility regarding what products are used for which patients and when, and what outcomes the products and care processes offer patient populations. The embedded automated tools in a highly visible healthcare setting make adverse events less likely to happen. Visibility in healthcare systems offers providers a “double-check” and accurate verification to reassure patients they are receiving safe care. Knowledge that they are using the right product gives provider teams confidence that they have the tools to guide safe practice; in turn, that gives patients confidence in the system as well as significantly reduced risk of harm from adverse events. Value for Clinicians and Provider Teams Healthcare providers view themselves as leaders in quality and advocacy for patients.51 In order for providers to deliver care, they require clinical environments that enable and support the delivery of safe, accurate and effective care processes for all patients and their families in a timely manner. Healthcare systems with high visibility enable and support provider teams by ensuring them access to detailed and accurate patient information. Visibility for clinicians and providers has multiple facets. Visibility across the continuum of care While clinical teams and providers see patients every day in healthcare settings, they do so with little insight into, or visibility of, the patient’s medical record across the continuum of care. This lack of visibility also limits providers’ ability to access patient information profiling the client’s history—their unique needs, current treatment, responses or sensitivities, health services accessed, care professionals seen, what transpired during these visits, and what has worked or not worked in terms of outcomes. A recent study found that only 12% of primary care physicians in Canada were notified of their patients’ hospital encounters, and fewer than 3 in 10 primary care physicians have electronic access to clinical data about a patient who has been seen by a different health organization.59 Visibility overcomes the loss of information that is so common during transitions in care and places patients at significant risk for adverse events, simply because of poor communication of patient care needs across transitions between provider teams. In a highly visible system, clinicians no longer “work in the dark.” They can readily access information— how many times a person has been to the emergency department, or what exacerbations or health challenges have been experienced in the last several days, weeks, months or years. Providers have access to outcomes of specialist care, wait times between these phases of care and line of sight towards how the condition or health outcomes may have changed over waiting periods.

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Visible health systems require the adoption of current software and RFID technologies to strengthen electronic medical record (EMR) systems and to offer more accurate tracking of patient care transactions at the product and patient levels of detail. Visibility technologies engage and track existing health information data files that capture patient transactions (admissions, discharges, transfers) and scheduling software to track provider–patient care transactions. This data is linked to patient outcomes simply by attaching unique patient identification numbers to existing transactional data feeds in health organizations, enabling care transactions for each individual patient to be tracked. The software needed to achieve this ability to track, trace and report patient processes simply adds patient identification to existing software tools already offered by most IT platforms currently in use in health systems. The incremental cost of adding patient identification to capture individual patients and product use can be financed through the significant savings achieved as a result of fewer adverse events (up to 40% reduction in one hospital system [Robin Walker, MD, personal communication, 2016]), and cost savings due to inventory management processes that are automated and require much less labour to sustain. Visibility of care across provider silos The same challenge in tracking exists within organizations. Often within the four walls of a single organization, prescribed care is not tracked or shared between departments. Inpatient units have little information about outpatient clinic visits. Healthcare staff must chase paper trails for patient information and rely on individual clinician decisions for medications, even when little evidence is available of past events with that patient. Care transitions are one of the highest-risk phases of care owing to inadequate communication of patient information from one provider team to another. Care transitions entail high risk both within and across organizations. Further, the administrative burden of manual tracking between units in a single organization is very frequent and creates unnecessary costs related to duplication. The siloed nature of Canada’s healthcare system is often viewed as a necessary or expected feature of a fragmented system. When healthcare providers are asked why a system of tracking and tracing patients and product use has not yet been put into place, the siloed nature of the system might be referenced as part of the problem. It is somewhat of a chicken-and-egg situation: silos exist in the system, so therefore a cross-sectoral, longitudinal tracking system can’t exist. Silos exist also because of organizational structure and culture that are further limited by the absence of visibility in the system. Thus, every patient interaction with a provider must necessarily start from “ground zero,” requiring the provider to assess patients in detail, go over every event or care interaction they have experienced, and recount medications, treatments or procedures they have received in their care journey. Providers must piece together the patient’s story in sufficient detail to inform care decisions, and they must rely on the accuracy of patients’ account of their history when making these decisions. In a highly visible healthcare system, clinicians can access a fully tracked and traced record of patient care to visualize the trajectory of the patient’s care journey. Such access informs provider teams or clinicians of the professionals with whom they will need to engage or collaborate across the continuum of care, including clinical specialties and clinical units. Some organizations—such as St. James’s Hospital in Dublin, Ireland—now use software tools and smartphone apps to track patient care needs across clinical environments, including hospital care and 42


home care, leveraging data feeds from existing IT platforms. Data sharing remains highly encrypted to protect patient privacy and enables patients and their caregivers, as well as their provider teams, to track care processes and outcomes from hospital to home environments to support visibility of care across the entire system. Clinical environments that have the tools available to enable staff to track the cascading effects of their medical decisions and treatment courses, and to use this information to inform patient care decisions, are necessary to achieve patient safety. One important observation on the challenge of “working in the dark” states, “We cannot change the human condition, but we can change the conditions under which humans work.”60 Reduced workload burden One of the key issues related to current safety reporting systems is the workload they place on healthcare providers. This factor increases the burden of safety reporting, and when combined with the very limited line of sight towards the return on investment, may be a key reason that the adoption of systematic reporting systems has not been achieved to date, particularly in Canada. A 2003 study61 found that nearly half of Canadian physicians opposed mandatory reporting of adverse drug reactions, viewing this as an extra burden on their practices. Further, healthcare workers often lack the knowledge to access current reporting systems that are in place. For example, a study62 involving a wide range of departments within six South Australian hospitals surveyed 186 doctors and 587 nurses in order to determine the hospitals’ incident reporting system and hindrances to its use. The study found that 98.3% knew about the existence of the system; 88.3% of nurses and 43.0% of doctors knew how to access a report; 89.2% and 64.4% had completed a report; and 81.9% and 49.7% knew what to do with the completed report. The study found that the main barriers to incident reporting, for both doctors and nurses, were time taken to fill out the reports; lack of knowledge regarding which incidents should be reported and whose responsibility it was to fill out the report; and a lack of feedback regarding any action that had been taken as a result of their incident reporting efforts. Likewise, in Canada, as of 2006, only 19% of physicians were even aware of Health Canada’s centres for reporting adverse events.63 In a highly visible system, the workload required to complete adverse event reports for clinicians and provider teams would be reduced from what it is in today’s more antiquated system. Digital tools in clinical environments, such as tracking all medications administered, automatically generate reports to clinical leaders and decision-makers, thus tracking all adverse events. The intention is to identify root causes so that clinical processes can be strengthened, preventing future events across organizations. These reports are generated by software that captures the transactions patients experience (medications prescribed, home care treatment completed, admission for surgery, diagnostic imaging or lab testing) and identifies the patient, provider, location of the event and any alerts (such as wrong medication) generated by the software to identify potential safety risks. The software automatically reports every situation or event where an adverse event occurred or was averted by the system. Such automated reporting not only informs organizations and provider teams of the patterns of potential or actual adverse events; they also inform strategies to mitigate future risk and inform accountability frameworks related to quality and safety initiatives.

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Patient safety interventions themselves add extra workload for healthcare providers. Branch-Elliman64 found that nurses had to spend an extra 115 minutes per patient per day to complete the steps required in the intervention to reduce potentially preventable pneumonia from ventilator use. Baker agrees that the expectation of adding significantly to workload is unrealistic, noting, “Patient safety interventions without a full assessment of the impact of these interventions on their workload [should not be implemented]. Greater attention to the workload impact resulting from these efforts will help to ensure that teams are capable of integrating these new routines into daily practice.� 65 Automated adverse event alerts and recalls In a highly visible health system, all adverse events are flagged and automatically reported to ensure that incident disclosures and reporting outcomes are embedded in the clinical environment and part of clinician workflows. The data is highly visible to provider teams, thus enabling standardized and comprehensive reporting that accurately tracks adverse events and their outcomes. Simply embedding barcode scanning or RFID tracking into clinical environments automates the workload for provider teams, who can easily identify all clinical services (surgery, medications, clinic visits) received by individual patients, creating a proactive system of reporting. This allows provider teams to identify patients at risk for adverse outcomes and informs approaches to managing and mitigating risk for all patients. Objective data can be linked to stakeholders to create a system of learning and accountability, while at the same time minimizing workload demands on provider teams because manual reporting is no longer required to capture data on adverse events. The automated tracking and tracing of a visible healthcare system also enables automated recall management in the event of a failure in product performance. Consider the following example. Dr. John Williams’ Story Dr. John Williams (a pseudonym) had received joint resurfacing surgery to manage osteoarthritis in his hip in 2009. At that time, an acetabulum cap made by a large global national company was very popular because it allowed surgeons an alternative to total hip replacement: a protective cap was placed on the head of the femur to insulate and protect it from further damage and associated pain. In 2014 Dr. Williams noticed a class action lawsuit, reported on the Internet, that was launched on behalf of patients who had received joint resurfacing surgery between 2003 and 2009. Patients who received this joint resurfacing device were now experiencing chrome and cobalt toxicity, causing severe cardiac failure in at least one-third of the 376,000 patients who had undergone this surgery. Dr. Williams was found to have twice the levels of serum cobalt and chrome that were considered safe in humans. He now undergoes extensive cardiac testing every three months to monitor for heart failure, and is weighing the decision to undergo hip replacement surgery. There is no protocol for removal of the resurfacing appliance that minimizes further leakage of cobalt and chrome. Dr. Williams has undergone three hip surgeries to date; following his last surgery, he experienced a severe infection in the hip joint that required months of antibiotic therapy. No reporting system alerted Dr. Williams to the product failure; news of the class action lawsuit was his first indication of the risks he was now facing. Currently, there is no system tool that enables hospitals to identify the patients who received this resurfacing device so that they might be notified and followed up to mitigate the risk of cardiac failure. (Source: Anonymous, personal communication, July 2016)

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Product identification and patient outcomes tracking Product performance is another example of a key value proposition for clinicians in a highly visible healthcare system. Surgeons use a wide range of products, joint implants and many other devices in an effort to offer patients the safest and most effective care possible. But without systematic tracking of products used in clinical procedures and the resulting patient outcomes, surgeons and other physicians have no way of knowing which products achieve the best results for different segments of the population. In a highly visible healthcare system, every joint implant, such as the one received by Dr. Williams, would be tracked and linked to every patient. As the adverse effects of a product began to emerge in a population, the daily tracking, traceability and reporting of patient outcomes would be readily observable and identified by clinical teams to prevent putting other patients at risk. The objective and automatic tracking of implants and other devices used for all patients would enable providers and organizations to notify patients of possible risk directly and facilitate assessment and monitoring for potential adverse events. Surgeons would access regular reports of patient outcomes to quickly and effectively identify risk of product failure and would be able to respond to find alternative products with evidence of safety outcomes. Patients who had received recalled products would be automatically identified and notified of the recall, just as in other sectors, such as grocery and automotive. Rather than 376,000 patients undergoing resurfacing surgery with a defective product, many fewer would be at risk today in a visible health system because the product failure would be identified more quickly and accurately, enabling providers to stop using the defective device and prevent further risk to such a large population. Early warning system In a highly visible healthcare system, the use of barcode scanning or RFID would immediately track and trace products, processes and patients to inform clinicians of the details of the patient’s journey with a high degree of accuracy, minimizing the need to rely on patients to relay this information. Tracking and tracing patient outcomes and care transactions would essentially provide an early warning system to alert clinicians, reducing the number of patients potentially exposed to risk of adverse outcomes. If these early warning systems were in place, adverse events would be minimized, in turn reducing workload for clinical teams who could quickly and easily access necessary patient information. The added workload of notifying and monitoring thousands of at-risk patients would be reduced, freeing up capacity in healthcare systems. The stress of identifying and then informing patients of risk of product failure would decrease markedly, further strengthening the quality of worklife for clinicians. One surgeon has shared the following observation, which illustrates the impact a highly visible health system would offer her worklife: “I have been trying to identify what kind of stent my patient has so I can determine whether it is safe for her to have an MRI (which is needed to identify how best to plan her surgery). It has been three days of trying to find this information while she waits in hospital; she is stressed and I am frustrated trying to figure out why we cannot identify this stent so I can help this patient.� (General Surgeon, personal communication, May 2016) 45


The value of a highly visible healthcare system offers greater quality of worklife for clinicians because they can easily access patient information when it is most needed, accurately and objectively, to inform decisions and provide the safest care possible. Value for Healthcare Organizations Organizations strive to balance patient care demands and wait times within fiscal resources that support safe, high-quality care delivery. Visibility achieves value for the healthcare organization in terms of safety, efficiency, effectiveness and sustainability. Healthcare organizations work within tight budgets and must use their limited resources wisely. One large area of spending is in the procurement and purchase of infrastructure, consumables and day-today goods and services. To do this efficiently, procurement departments must have valid and reliable information on product demand and quantities required for each unit. Yet purchases are often made without forecasting or objective information on patient demand and need. As a result, procurement departments may purchase too much, too little or the wrong type of product, equipment, service or medications for a unit. The proper tracking and tracing of goods, consumables and medications within a healthcare organization would promote more efficient procurement and better use of funds, ultimately improving organizational efficiencies and saving costs. Information regarding product performance and outcomes would add tremendous value to procurement teams, offering data to inform purchasing decisions and to determine the value and return on investment linked to product and patient outcomes. Highly visible systems achieve significant cost savings to healthcare organizations and the healthcare system as a whole. Inventory savings Inventory savings have been identified anecdotally in a number of reports.66 In a current study (Snowdon, in press) of system leaders in the UK, Australia and Canada, respondents estimate an $8 million savings in inventory tracking and product procurement for every $1 million invested in infrastructure (such as standards adoption, barcode scanning and data infrastructure). These figures do not include additional savings related to patient safety and to fewer product shortages and less waste due to expired product. Inventory management has been a significant focus in US health systems, and it is now emerging as a focus in Canadian healthcare systems. Supply chain transformation would provide a means of accurate planning and procurement and also reduce waste in the system, thereby further reducing costs to healthcare systems. Accurate, value-based procurement The true value of a product or technology can be determined only when it is linked to patient outcomes, product performance and the product’s contribution to those outcomes, and the impact on workload and ease of use for clinicians. Visibility in healthcare systems makes it possible to accurately assess the cost and return on investment of products through such linkages. In highly visible systems, 46


procurement teams would work closely with clinical teams to review product outcomes, tracking these to identify the real cost and value for patients and the workload impact for clinicians. Automated tools to track patient outcomes remove or reduce the challenge of determining value in procurement processes because traceability of product demand and use provides empirical evidence of value. There is a widespread view that physicians are a major barrier to supply chain transformation because many “prefer” a particular brand of products, particularly in cardiology, spinal medicine and orthopaedics.33 Yet, a key enabler of improved supply chain performance is leadership from physicians who understand the value proposition in improving the supply chain, which accounts for the second largest healthcare cost after labour.67 Highly visible health systems provide evidence, based on objective tracking and tracing of patient care processes and product use, that offers a rational basis for decision-making in procurement and standardization of health products used in patient care. Accountability to patients The highly visible health system has embedded in it a framework for accountability. When patients are able to access the details of their care journey, they gain a heightened sense of confidence. Patients and their caregivers are better informed of their personal transactions in a highly visible system; further, quantifiable reporting on health system performance, such as hospital “report cards,” supports patients in making future healthcare decisions, and promotes improvements in the quality of care.54 In fact, public reporting has been found to improve measures of healthcare performance in addition to quality measures over time.55 In the US, several public websites provide such hospital report cards, allowing consumers to view hospitals by name. Performance is ranked in several areas, including safety. A variety of similar hospital report cards are also available in the UK. Significant cost savings We could find no empirical evidence of the cost savings and economic value of supply chain transformation in healthcare systems. However, many global leaders in supply chain innovation have identified that cost savings can be achieved when tracking and traceability of product inventory are automated and embedded in the clinical infrastructure of healthcare settings. The cost of adverse events within the Canadian acute care system between 2009–2010 is estimated at $1.1 billion, with preventable adverse events costing an estimated $397 million.68 However, these estimates do not take into account other associated costs, including out-of-hospital care or loss of worker productivity.68 At an international level, estimates suggest that harm due to erroneous medical care makes up a cost of “at least one dollar in every seven dollars spent on hospital care”69; a figure as high as 14% of total healthcare expenditure has been suggested.70 Figure 9 identifies the estimated cost of medical error in today’s global healthcare systems. These cost estimates account only for hospital adverse events; we could find no estimates of cost related to adverse events or error in the community that results in hospitalization, or other health system costs.

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Figure 9: Estimated Cost of Preventable Adverse Events “It is estimated that preventable errors cost the United States $17–$29 billion per year in healthcare expenses, lost worker productivity and disability.” $17-$29 billion (National Quality Forum, 2016) “This report suggests a cost of preventable adverse events that is likely to be more than £1 billion but could be up to £2.5 billion annually to the NHS.” £1-£2.5 billion (Exploring the costs of unsafe care in the NHS, 2014)

“The economic burden of adverse events in Canada in 2009–2010 was $1.1 billion, including $397 million for preventable adverse events.” $397 million

(The economics of patient safety, 2015)

Value for Industry The pharmaceutical and medical device industries rely on sales of products (drugs and devices) that enable healthcare systems to meet the needs and demands for care. In many cases, these are lifesaving treatments and interventions that greatly increase life expectancy and quality of life for many people. Yet, manufacturers have no access to objective health system data or evidence of outcomes to inform innovative product design and development. In the current system, industry representatives have very restricted access to clinicians or clinical teams, usually limited to conferences or occasional sales meetings. In addition, there is no objective, data-driven evidence linking product use and patient outcomes to product design and performance. Similar to clinician teams, industry and innovative entrepreneurs “operate in the dark” and have no line of sight into health system needs, priorities or population demands for clinical care and practices. Healthcare systems rely very heavily on companies to design and develop cutting-edge technologies and innovative products that enable clinical teams to deliver high-quality, safe, effective care. In a highly 48


visible healthcare system, the tracking and reporting of patient care, products and outcomes enables systematic assessment and in vivo evidence to demonstrate product performance. Visibility also affords much greater objectivity and accuracy in assessing product performance based on automated scanning of barcodes to identify those products that are being used in particular clinical settings, the patients who are receiving them, and the frequency and purpose of product use. Such a visible system quickly and accurately identifies patient risk early, before thousands of patients receive products or care that place them at risk. In a visible system, industry is empowered to identify the needs of patients and clinician teams in healthcare systems based on objective evidence, in contrast to the current system, which is challenged to engage industry partners. Manufacturers are able to assess the value of their products, identify which products work best for which segment of patients, and determine how the next generation of products can be improved. Transparency also offers manufacturers insights into whether products are being used as they were intended, and can offer accurate data to identify when and where error in the use of a product needs to be addressed. Industry has made much greater progress in adopting global (GS1) standards to support visibility in healthcare systems worldwide than Canadian healthcare systems have been able to achieve to date. The majority of global pharmaceutical companies have enabled tracking and tracing of all medication and pharmaceutical products, placing GS1 barcodes on every product released in the marketplace. The Canadian Pharmaceutical Barcoding Project has made headway in attempting to establish tracking and identification of pharmaceuticals to reduce preventable medication errors.71 While this project detects and attempts to address preventable medication errors caused by human error, the tracing of pharmaceutical use in aggregate to show adverse events and reactions of drugs has not yet been demonstrated. For pharmaceutical products, post-market review is generally lacking at the regulatory level, leading to problematic prescription and consumption practices, without all necessary safety and adverse event data.72 Moreover, despite the importance and relevance of medication errors in patient safety, health organizations such as hospitals have made limited progress in scanning medications in patient care. In summary, the chief value of a highly visible system for industry is access to objective evidence of population health needs, demands for care, and product performance relative to patient outcomes. Such data can inform the development of the next generation of product innovations. Value for Healthcare System Leaders and Policy Makers Value for healthcare systems is defined by the quality outcomes achieved across a defined population served by the health system and the cost of providing that care.73 Yet, value is not well measured for the majority of healthcare systems.73 Visibility in healthcare systems—relative to accurate measurement of cost and quality outcomes at the product and patient levels—holds the potential to accurately measure value.

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Porter 73 underscores the importance of the visibility agenda in delineating how healthcare systems must achieve value, making clear that what is most centrally important in healthcare is what matters to patients, and that value for patients must therefore be central for all stakeholders in the system. “Achieving high value for patients must become the overarching goal of health care delivery, with value defined as the health outcomes achieved per dollar spent. This goal is what matters for patients and unites the interests of all actors in the system. If value improves, patients, payers, providers, and suppliers can all benefit while the economic sustainability of the health care system increases. Value—neither an abstract ideal nor a code word for cost reduction—should define the framework for performance improvement in health care. Rigorous, disciplined measurement and improvement of value is the best way to drive system progress. Yet value in health care remains largely unmeasured and misunderstood.”73 —Porter ME. “What is value in health care?” N Engl J Med. 2010. The value proposition for policy makers of a highly visible system is linked to the legislated mandates of publicly funded healthcare systems such as those in Canada, the UK, Australia and the US Medicare/Medicaid/Veterans Affairs healthcare systems, among many others. The objective and comprehensive data that comes from a visible healthcare system can also be used to guide and inform cogent policy and legislation strengthened by objective evidence that is fully visible across entire health systems. For example, the Canada Health Act—the federal legislation that guides all provincial healthcare systems—protects and upholds the expectation of the Canadian public, through the legislative requirement for all healthcare systems to be publicly administered. The Canada Health Act states that “the primary objective of Canadian health care policy is to protect, promote and restore the physical and mental well-being of residents of Canada and to facilitate reasonable access to health services without financial or other barriers.”74 Ministries of health in every province and territory must uphold the key legislated requirements of the Act, including public administration (services must be operated on a non-profit basis by a public authority), portability (care must be offered in any jurisdiction to all insured people), accessibility (access to care must be “reasonable”), universality (all insured services are covered for all insured individuals) and comprehensiveness (policy covers all insured health services provided by hospitals, medical practitioners or dentists). All healthcare systems are accountable for meeting these legislated conditions in order to secure federal transfer payments to support health system care delivery. However, with limited visibility of how the system achieves and delivers on these principles, it is challenging to meet the public accountability mandate if the public cannot fully “see” and understand the degree to which healthcare systems are achieving value for the populations they serve. It is also challenging for health system stakeholders (clinicians, organizations, industry, policy makers) to make visible the degree to which healthcare systems are achieving their mandated outcomes, or how system processes can be strengthened to more effectively and safely deliver care. Despite legislation to support public administration and accountability, there is very limited visibility for consumers to fully understand the value that healthcare systems are delivering in terms of safe health 50


services. A key finding of a prior publication, Measuring What Matters: The Cost vs. Values of Health Care,51 was the need for healthcare systems to have visibility of health, wellness and quality of life, rather than current outcomes measured by healthcare systems such as mortality, morbidity and safety (for example, prevalence of falls, infections acquired in hospitals). Visibility in healthcare systems creates the opportunity to enable and support all stakeholders in achieving the value of safe and effective health outcomes to promote wellness and quality of life.

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Solutions Patient safety is a formidable challenge for healthcare systems; the potential for serious harm and death affects hundreds of thousands of people worldwide annually. Decades of research into the prevalence of adverse events in healthcare has created awareness of patient safety issues, but the rate of deaths due to medical error has now become the third leading cause of mortality in North America. The environment in which healthcare is delivered is a key contributor to safety outcomes across healthcare systems. Supply chain processes that create high visibility in healthcare delivery offer clinician teams the tools to ensure that “never events” truly never happen and that adverse events become a thing of the past. Supply chain transformation in healthcare builds on the legacy of progress made in every other business sector in the world, creating the conditions to achieve value through visibility. The benefits are obvious. A highly effective and uniform health sector supply chain reaches across institutional boundaries, is centrally organized and focused on the patient and population, makes visible every step of healthcare services, allows measurement of health processes and services, and contributes to every person’s goal of health, wellness and quality of life. This paper has outlined the many parallels between the health sector and other industry sectors, with the exception of supply chain optimization. Fully visible healthcare systems have dynamic reporting and feedback procedures to inform stakeholders, to deliver safe and effective care and to disseminate “lessons learned” regarding adverse events across global borders to support the prevention of adverse events worldwide. Consider a system whereby adverse events in one country are immediately shared with provider teams in other countries to guard against multiple such events occurring across populations. Visibility means alignment with other global healthcare systems to support the safest, bestperforming approaches to care that deliver value and optimal outcomes to the populations they are mandated to serve. Highly visible healthcare systems leverage the expertise of other business sectors to achieve the same or greater value proposition for consumers. They do this by creating clinical environments that make it nearly impossible for “never events” or adverse events to occur, building consumer confidence in healthcare systems. This paper has mapped out the strategy for healthcare systems to translate proven supply chain processes to create a dynamic clinical infrastructure that will enable healthcare systems to track and trace every product, process and patient transaction so that risk can be proactively identified and managed to achieve the best possible outcomes for patients while optimizing the use of resources to realize value for populations. Ultimately, our goal in this paper is to reframe the challenge of patient safety into a system infrastructure opportunity that creates clinical environments to support the delivery of the safest care possible. Supply chain transformation is the future for accountable healthcare systems that demonstrate the return on investment in delivering healthcare that is safe and highly effective in performance and quality.

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The following solutions are proposed to advance the design and implementation of transformational supply chain strategies in healthcare systems to achieve highly visible and high-performing healthcare delivery. 1.

Create policy frameworks to support a common language across global jurisdictions to support tracking and traceability of products, patients, care processes and outcomes for global surveillance of safety and value for populations. Canadian government ministries, accreditation bodies and federal regulatory agencies must create policy frameworks that align with global jurisdictions to incentivize and create the necessary catalysts to guide supply chain transformation. This can be achieved by requiring and mandating all organizations and provider teams to adopt global GS1 standards to enable the traceability of people, products and processes in all healthcare settings. Adopting global standards for traceability sets the stage for a fully visible healthcare system in which every clinician team, every health organization and every health system in the world is “speaking the same language,” whereby a product or a process is linked to individual patient outcomes. These standards provide the mechanism to ensure that every unique product is identifiable anywhere in the world. GS1 standards have been adopted by more than 20 different business sectors worldwide, and so already have significant proof of concept across numerous jurisdictions. A global standards-based approach not only benefits healthcare systems; it also offers manufacturers and suppliers consistency in business processes for their customers to streamline costs and drive more efficient manufacturing and distribution of products needed in healthcare systems. This policy recommendation is a first and very critical step that makes it possible for health system organizations to begin to mobilize and achieve the value of strategic supply chain transformation.

2.

Invest in infrastructure. All healthcare organizations—hospitals, primary care settings, home and community care agencies, long-term care, complex care and rehabilitation facilities—must invest in transforming clinical environments to integrate automated digital tracking tools and devices so that every healthcare provider can track every patient, procedure and product used in its setting. The introduction of barcode scanning equipment that links every patient to the location and type of procedure, and the products used to deliver care services, transforms clinical environments into highly visible settings. Such settings visually display patient identification, procedure steps and products used in patient care to enable clinicians to automatically identify and ensure that the right patient (GSRN) is receiving the right care and the right products at the right location by the right provider team. This recommendation will reduce adverse events substantially and essentially eliminate never events in healthcare settings, particularly hospitals, where the highest-risk processes of care and use of products and medications take place. This infrastructure investment achieves the following: 

Rapid and dynamic feedback of patient, product and procedure tracking for clinical teams to identify situations at high risk for adverse events. Rapid feedback ensures that steps are taken to intervene and protect patients from adverse events, thereby enabling providers to 53


3.

deliver the safest care possible and ensuring that care is delivered when and where it is needed to restore or support patient health and wellness. Reduced clinician workload that overcomes the limitations of voluntary reporting and recording of adverse events. Scanning to link patient outcomes to procedures and products is highly automated; it achieves visibility and documents every process, provider and product used for every patient systematically, using GS1 standardized definitions. These are searchable and analyzable in order to generate evidence of outcomes and value across organizations, clinical teams and healthcare systems serving unique patient populations. Automatic feedback to patients about the use of products. In this way, patients have a record of the exact product they have received (medications, joint implants, pacemakers, stents, vascular filters), the professional who prescribed it and when and where it was administered. This information can inform the patient’s future care decisions with all provider teams in all clinical settings. An accurate and accountable system for measuring value in healthcare delivery. The system documents every patient transaction, including products used and patient outcomes achieved, to calculate and measure true value of healthcare delivery.

Establish a national digital product registry. A national product registry could be linked to the Canada Health Infoway mandate to “improve the health of Canadians by working with partners to accelerate the development, adoption and effective use of digital health solutions across Canada.” A digital registry of health products, accessible to all health system stakeholders who use it, offers access to accurate and up-to-date data on all healthcare products. A national registry also makes it possible to implement post-market product surveillance to ensure that only the safest, highperforming products are used in healthcare to achieve health and wellness outcomes for patients. This goal can be enabled by combining product data with clinical data from the EMR or product registries, using the GS1 standard barcodes as the index key. A national registry eliminates the burden for health professionals or staff of having to key in product information and data manually, thus also reducing the administrative burden downstream when product data is inaccurate. A national digital registry offers the added value of supporting cost-effective and accurate e-commerce supply chain processes to ensure that products are available and distributed to clinical settings when and where they are needed. The registry should leverage the strengths and expertise of existing national registries, such as the joint registry managed by CIHI and registries in other countries such as Australia and the UK, which are highly regarded by the scientific community worldwide. A national health product registry would achieve six key outcomes for Canadians: 

Ensures that health products are accurately identified, including validated product attribute data that is highly visible to clinicians to contribute to patient safety. Product data accuracy is maintained by the national registry, with a complete listing of all of the required attributes (legislated by such agencies as the FDA or Health Canada) for every product. This would enable digital e-commerce processes for healthcare systems to effectively order products, track inventory and distribution, and reorder when products need to be replenished.

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4.

Enables rapid and accurate recall communication that is coordinated by a single national entity. In this way, recall information is widely disseminated digitally to every clinical setting and every clinical team in hospitals and communities to limit the risk of population-wide exposure to adverse events associated with product failure. Enables direct product information, including notification of recall, communicated to patients and their families to inform patients and providers of product performance and outcomes. Product information, such as key attributes (for example, latex, metal, manufacturer) could also inform healthcare decisions, such as use of MRI diagnostic imaging for patients with implanted devices. Enables value-based procurement that leverages traceable product costing, performance, usability and patient outcomes. This approach can inform procurement decisions and also engages clinician teams in procurement to assess clinical value based on objective data. Establishes clear communication and transparency with vendors. Product use can be identified relative to patient population segments, patient outcomes and product performance to stimulate and accelerate the opportunity for product innovation. Supports and disseminates results of post-market product evaluation and tracking to identify patient safety outcomes at the population level. Early identification of safety outcomes helps to prevent broad exposure to risk at the population level. Global collaboration across registries in OECD countries offers significant value for populations and for health systems.

Build leadership capacity. Leadership capacity in supply chains is a strategic asset; it can be developed by leveraging the expertise and experience of strategic supply chain leadership demonstrated in other sectors, such as the grocery, retail pharmacy, travel and automotive industries. The private sector currently has significant expertise in supply chain management, particularly manufacturers and distributors who have engaged and built capacity across their networks. In contrast, leadership capacity is lacking in health system organizations. Hospitals, long-term care facilities and home care organizations have limited expertise in managing and creating strategic supply chain management strategies to achieve visibility. The leadership capacity must be embedded in the care delivery system to achieve visibility. Creating a council of strategic advisers that engages the necessary expertise could advance supply chain transformation in healthcare systems. Mobilizing leaders in other sectors as strategic advisers (C-suite leaders) for health organizations and health system/policy leaders (ministries of health) will build on the strengths of other industry sectors and accelerate supply chain transformation. Specific leadership capacity-building initiatives may include the following: 

Provincial government ministries need to develop a roadmap and business case for where and how health sector supply chain innovation investments should focus in the near, interim and long term, and how the value of such investments will manifest and be measured for all stakeholder groups. The success of the Canadian Blood Services organization can be leveraged to build on the robust supply chain measures and infrastructure for blood and human tissue products to expand this supply chain infrastructure across health systems. 55


5.

Business schools need to create the empirical evidence for the business case of supply chain transformation, documenting which strategic investments create value, where they need to be made and in what order and magnitude, and how those investments can be leveraged to achieve safety in clinical care. Business schools must also be mobilized to build capacity, expertise and research in supply chain and logistics for the health sector to develop the next generation of leaders to guide and shepherd supply chain transformation across healthcare systems nationally and globally. Canada Health Infoway and the Canadian Institute for Health Information (CIHI) offer a national engagement opportunity to build collaboration across health systems nationally to link patient safety and quality data to supply chain innovation investments.

Design and implement supply chain visibility scorecards. A “visibility scorecard” for ministries of health and accreditation organizations would measure progress towards achieving visibility for healthcare systems. As organizations and regional systems progress in achieving supply chain visibility, indicators in the framework would illustrate and inform leaders and stakeholders of the impact that visibility in the system is achieving for patients and families. Such a scorecard would include visibility indicators for safety and product recall that are accessible to patients and families, clinicians, industry and health system leaders. Visibility scorecard reports would be automatically generated and disseminated for stakeholders to include an analysis of adverse event tracking. This would enable the setting of targets to achieve improvement in adverse events. Visibility indicators and target goals for both industry and health system stakeholders would focus on such indicators as inventory costs, targets for cost savings, product performance value indicators (cost of product/value achieved for patients) and inventory tracking. Specific examples of visibility indicators could include the following:    

Number and type of clinical settings in a health system with GS1 standards adopted and in use. Number and type of clinical settings with digital tools to scan, track and trace every product and process linked to patient outcome data. Adverse event and “never event” tracking automated and reported (daily/weekly) to inform clinical teams, organizations and systems of progress in safety outcomes. Patient volumes and procedure tracking to assist organizations in health system resource planning, and to inform manufacturers of product demand projections to reduce costly overstocking or product shortages that contribute to adverse events. Inventory tracking to inform product demand trending and replenishment processes for manufacturers, distributors and healthcare systems, including data management and quality control systems, to track every product, replenish supply based on use and identify product demand patterns for inventory management. Clinical performance indicators that include product and procedure tracking data to accurately and objectively capture the value of care services for patients (cost of procedures linked to health and wellness outcomes for patients) and to inform procurement processes and decisions. 56


6.

Align national and global supply chain policies. Such alignment would streamline global supply chain processes and maintain Canada’s viability as an international market and partner. This initiative would involve organizations such as Health Canada and provincial ministries of health in aligning supply chain policy frameworks and pathways with other global jurisdictions to streamline the complex health system supply chain and achieve synergy across global jurisdictions. Healthcare is a global business sector; products are manufactured all over the world and distributed to every health system market. Hence, alignment of policy frameworks (for example, adoption of GS1 standards, streamlined regulatory processes) enables industry to achieve much-needed efficiencies in distributing products to multiple countries across the globe. This in turn would create economic value that contributes positively to the world’s GDPs and economic wealth. For countries such as Canada, where populations are small and distributed across a vast geography, alignment with other jurisdictions—such as Australia and the United Kingdom, which have made substantial progress and have similar health system governance structures—would make it possible and more likely for companies to distribute their products to all clinical settings and thereby improve health outcomes and quality of life for Canadians. For health organizations, streamlined policy and pathways would support and enable inventory cost savings and management, ensuring that clinician teams have the products available when and where they are needed for patient care. Fundamentally, adverse events and error in healthcare are an outcome of an underdeveloped supply chain. Transforming supply chain in healthcare creates the infrastructure in clinical environments to support clinicians to readily identify potential risk for patients and proactively intervene to prevent adverse events. Visibility within and across healthcare systems enables all stakeholders to deliver safe and effective care that contributes to health, wellness and quality of life for Canadians. Requiring, enabling and scaling supply chain traceability based on GS1 global standards achieves better value and builds confidence in the healthcare system. Supply chain infrastructure in healthcare can and must be transformed.

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Acknowledgements For their research support and thoughtful contributions to the manuscript, we gratefully acknowledge the following individuals: World Health Innovation Network Ms. Lori Turik Ms. Karin Schnarr Ms. Carol Kolga Dr. Ryan DeForge Dr. Renata Axler Dr. Phillip Olla Ms. Deborah Tallarigo Mr. Rishi Jain

Address for Correspondence Dr. Anne Snowdon World Health Innovation Network Odette School of Business University of Windsor 401 Sunset Avenue Windsor, Ontario, Canada N9B 3P4 Email: anne.snowdon@uwindsor.ca

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