Eric Manheimer Department of Medicine, New York university medical School, New York City, USA KEY POINTS

• The changing regulatory and economic context of healthcare is causing significant changes in focus for healthcare institutions.

• Patient safety, or harm free care, is an intimate part of the change process and for some organizations becoming the central component of their strategic plans.

• High Reliability Organizations are the next step in healthcare safety journeys.

• Significant impediments remain to achieve supportive safety cultures of engaged and activated healthcare workers.

The changing context of healthcare institutions and patient safety The US healthcare delivery system is so vast and complex that it has its own epidemiology of harm. [1] Pioneering studies published in the 1980s from retrospective chart reviews of discharged patients revealed that the healthcare delivery system itself was the cause of considerable morbidity and mortality. [2] The studies demonstrated that the injuries or harm to patients seeking medical attention in hospitals was underappreciated or unrecognized (and in the majority of cases uncompensated). The paradox of a healthcare delivery system being itself the proximate or enabling cause of a broad range of complications (morbidity and mortality) led to a growing patient safety movement, regulatory changes on the state and national level, payment adjustments by government and private payers that have gradually (and not uniformly) moved patient safety from predominantly a risk management function to a core principle of healthcare organizations at the cutting edge of health system transformation. The addition of a population health construct has blurred the lines of healthcare institutions' (hospitals, the payers, and healthcare systems) responsibility as health outcomes increasingly depend on an engaged patient in their community setting through the entire continuum of a health episode. [3]

The role of a healthcare institution built around the hospital is undergoing accelerated change prompted by passage of the Affordable Care Act. [4] This legislation is built on several decades of efforts to modify the dominant fee for service payment model and well documented incentive towards more care. A lack of coordination between institutions, physicians, patients, and their neighborhoods is moving towards an evolving model (accountable care and primary care medical home) whose ultimate goal is to reward the "right care, at the right time, in the right place."

The healthcare debate [5] and its outcomes are critical to how patient safety fits in the framework of a massive industry moving into an uncertain financial future. Cutler and colleagues [6] outline the delivery system consolidations now underway across the country. Integrated systems incorporating all of the components of a healthcare system from hospitals, to doctors, to an insurance system have become the models for controlling costs, standardizing care, and competing successfully in local markets. Accountable Care Organizations (ACO), the organizational agent of change, providing complete healthcare for their patient base requires broad collaboration and deep integration of primary and specialty healthcare from inpatient to community based services. Analytic capacity ("big data") by combining administrative and electronic health records (EHR) is becoming an essential component to proactively target and intervene in high risk patient populations, delivering focused preventive measures while creating registries for measuring performance in chronic disease management.

The central new paradigm for the hospital industry in the brave new world of accountable care and system integration is the value equation. The "Triple Aim" concept was introduced by Berwick [7] in a Health Affairs article in 2008. It boldly introduced ideas synthesizing research, pilot projects, and policy-making from many sources. [8, 9] The triple aim ties together improving population health, improving the patient experience of care, and reducing per capita costs. This has been adopted as the organizing strategy for the US National Quality Strategy. [10] The Quality Strategy aligns the federal government's regulatory, payment, and measurement goals that partially came to fruition with the landmark Affordable Care Act (ACA) legislation or Obamacare.

The value equation, where value = health outcomes/cost, becomes the underlying principle and potential industry "disruptor" uniting fragmented components of the healthcare system into an expanded and aligned organized way of thinking of healthcare delivery. The patient is the central agent driving an integrated delivery system. Measurable outcomes, constantly improving patient care benchmarked against best practices, with a flattened cost curve, becomes the "currency" of reputation and financial performance.

A key driver of change towards value-based care from a health system point of view is the regulatory-payer relationship. For example, from a safety point of view Never Events (surgical complications, pressure ulcers, hospital acquired infections) deny payments for an expanding list of avoidable complications of care. [13] Additional levers from CMS (extending rapidly from Medicare to Medicaid to private insurers) are pay for performance and readmission penalties. Most significant is the introduction of bundled payments for elective procedures for hospitals. Care is now "bundled" across the entire "episode" of elective surgery that includes pre-hospital care, hospital-based care, and months of post-hospital care condensed into one payment. The penalties for defects or errors in care are both financial and reputational. Care for an elective knee operation includes customized preparation for the patient pre-operatively, careful coaching for the patient and their caregivers, outfitting their home environment, and post-operative monitoring. The goal is seamless return of function using community outreach, tele-health, and other technological aids, thus operationalizing the value proposition by creating tight linkages between integrated care teams that span the hospital and the community. Ironically the surgical component is increasingly commodified while the entire planned episode of care is customized to an individual patient's needs physically, psychologically, and environmentally. In this context a readmission is a safety defect warranting an analysis of system failure. By extension large companies (Walmart) encourage their employees to have elective surgery at US centers of clinical excellence where discounted rates have been negotiated and transportation and hotel expenses are included. The employee pays the differential for local options. High volume surgical care has been causally related to less harm, higher quality, and lower cost. [14]

From a patient safety perspective, an avoidable hospitalization is a "defect" or adverse event. Patients are subject to potential adverse outcomes from tests and procedures. It also begs the increasingly relevant question of patient preferences and shared decision-making with active patient and family participation in their care.

The extension of care beyond the hospital walls driven by CMS payment incentives coincides with a theme of population health and intervention in the social determinants of health. The vulnerabilities of many communities put patients at risk for disease and for recovery. Neighborhood health is no longer just of interest to Public Health authorities. Three examples illustrate the evolution of hospital organizations' increased collaboration with their communities. Safety issues move "upstream" delivering the right care, at the right time, and preventing unnecessary care.

The Dartmouth Health Care Atlas [15] generates a national map of Medicare activity with millions of data points for a variety of conditions. The Atlas researchers have analyzed conditions from the last six months of life to elective surgery. Findings have shown significant variations in the intensity of care depending on where patients live independent of their co-morbidities. The implication is that the kind of care and the amount of care you get depends on where you live. The conclusion from ongoing Dartmouth Atlas studies is that local physician cultures govern practice patterns and influence utilization in the absence of clear treatment "best practices." End of life care can be managed at home, in hospices, or in hospitals. Prostate cancer has many treatment options including watchful waiting. During Obama's re-election campaign The Cost Conundrum published in the New Yorker, [16] summarized findings of significant care variations in two nearly identical Texas communities a few hundred miles apart and became the most widely discussed item as Obamacare was unfolding. Objections to the Atlas notwithstanding (that it is agnostic about social disadvantage and thus under-represents patients whose medical issues are compounded by poverty and the chaotic social stresses that accompany deprivation [17]), variations in care are a basis of learning about delivery systems and their side-effects. More care has not been associated with better outcomes, and there is a suggestion that it may be harmful.

While the underlying "pump handle" or causes of the vast majority of diseases are associated with behaviors and environmental exposures, the relationship or ownership of the delivery system to these "upstream" factors has been largely absent. As payers and hospitals have had to assume increased financial risk for their patient's health outcomes, the structural or social determinants of health, elaborated in a parallel public health database, is now the basis for collaboration between healthcare institutions, whether payers, hospitals, health systems, or academic medical centers and their communities. [18]

Hospitals and payers are now both aware and concerned over the health status of the communities they serve. In New York City if a patient is dual eligible for Medicaid and Medicare, requiring extensive medical care and social support, that patient is now capitated, a single payment providing all care. For the financially at risk health plans, a patient's personal "risk score" has broadened to include housing security, access to appropriate and timely clinical care (perhaps at home via house calls), communicating the "red flags" of decompensated congestive heart failure

[19] to an engaged and motivated caretaker. 911 calls, ER visits, and admissions are all potential system failures. Patient "non-compliance," lack of meaningful education, poor communication, and the absence of a healthcare plan and advanced planning are safety "defects" and result in exposure to risky and expensive healthcare environments. A delay in the treatment of a recurrent urinary tract infection in an elderly bed-bound patient recognized by a home health aid becomes sepsis hours later in an intensive care unit. Safety and the concept of errors and adverse events have expanded beyond the hospital walls into what might best be thought of as a "boundary-less" hospital.

The social determinants of health include income inequality, housing insecurity and homelessness, educational differentials and health illiteracy, food quality,

exposure to violence in the home, safe neighborhoods, mental health, and addiction issues. The example of obesity has moved onto center stage as both a personal health and a public health problem. Medicalized solutions are not the principal treatment options for a social epidemic. From modeling and making available healthy foods, to collaborations with community organizations to protect children from exposure to omnivorous messaging for hi-density caloric foods, these are examples of growing partnerships. The fusion of public health with health delivery is changing the patient's environment through delivery system activism and the recognition that patient engagement and motivation is a critical success factor in patient care. These represent new skills for health institutions and are redefining what patient safety means as neighborhood-health system interventions spread, are normalized, and lead to improved quality and safety (less patient harm), improved patient satisfaction, and enhanced reimbursement.

The lack of access to primary care or uncoordinated primary care results in overuse of emergency rooms and unnecessary admissions. The concept of avoidable hospital use or ambulatory care sensitive conditions includes congestive heart failure, diabetes, asthma, and other common medical conditions. [20] Algorithms running on hospital administrative databases can flag possible primary care deficiencies by querying all emergency visits and admission diagnoses. The blurring of what is the responsibility of hospitals and what are a patient's responsibilities are re-evaluated from the neighborhood perspective. The de-siloing of communities and care delivery is aided by county disease and risk factor geo-maps supported by the Robert Wood Johnson Foundation. [21] There is appreciation that community health is a net result of "health in all policies" including education, transportation, green spaces, family support, physical safety, and healthcare availability. Is an asthma exacerbation the result of a non-compliant patient? Or is the exacerbation a failure of patient/family engagement in self-management? Or is it the result of the trucks that contaminate the neighborhoods on their way to central distribution centers? As communities and their health institutions look at their rates of illness and exposure, solutions require multifactorial comprehensive solutions, not just more trips to the emergency room.

The radical idea in the Triple Aim for transformation of our fragmented healthcare system, producing too much care, not enough of the right care, [22] overpriced [23] and harmful to your health [24], support a framework for all of the stakeholders to focus on value (error free and high quality) delivered to the patient as the core underlying driver of change.

While there will always be tension in healthcare institutions over competing goals, patient-centered and harm-free care can be a unifying platform for high performing systems along with lower unit cost. The search for the high reliability organization, [25] - a healthcare organization that can deliver high levels of defect- or error-free care over extended periods of time throughout its entire range of delivery processes from surgery, to intensive care, to specialized units (transplant to obstetrics to oncology) to end of life care and transitional care outside the hospital - is now on the map for organizational leadership, government payers,

and regulators as both desirable and possible. The questions for policy-makers are the proper incentives and timeframes using the twin levers of regulation and financial carrots and sticks to move hospital systems into a new care model. The issue for CEOs of healthcare institutions is to gauge their organization readiness and the relative risk of moving or not moving into a value denominated reimbursement system.

Institutional core competencies for safety US healthcare organizations are not monolithic and all are subjected to different local pressures that both constrain and mold their responses to the broad secular trends in the wider healthcare scene, such as the ACA, ACOs, and value-based healthcare and its challenges.

Hurricane Sandy devastated NYC in 2012. Three hospitals on the east side of Manhattan, within a few blocks of each other and with the same academic partnership, took three different paths to the possibility of an environmental catastrophe with a high risk of loss of hospital functionality from a storm surge. Hospital A evacuated several days before the hurricane touched down and a transformer blew, to "protect our staff and patients." [26] Hospital B - part of a large health system - chose not to decant patients and sustained loss of power and evacuated without lights or elevator service over several days into its sister hospitals. Hospital C decanted to half census, lost power, and evacuated emergently into NYC's other private hospitals. The Department of Health for the City and State had determined each facility could shelter in place given its evaluation of the Hurricane threat and experience with Hurricane Irene a year earlier (evacuation and no negative storm effects). Each hospital is under a different hierarchical management structure and interpreted its situation vis a vis Hurricane Sandy at different risk levels or threats to patients, workers, and organizational integrity. In a sense, Sandy is a metaphor for the variety of institutional responses to broad and deep changes (environmental challenges) affecting the healthcare industry, understood as either "threats" or "opportunities." [27]

Given the rapidly changing healthcare context and the variety of governance structures producing variable perceptions of threat to organizational integrity, the competencies required of healthcare institutions to achieve safer care are complex and depend on an organization's history, context, and leadership. Ultra-safe care supported by a deep safety culture is not a turnkey project, but an emergent property of an organization that self-consciously makes a commitment to core principles that support a long-term safety trajectory.

Institutional leadership plays a pivotal role in creating a safety environment. The characteristics of successful leadership in patient safety are consistent with success in all the areas of hospital alignment around the Triple Aim. [28] These characteristics are based around the new model of value driven healthcare where healthcare outcomes are constantly improved as costs are maintained or reduced. Patients are considered the key partner, redefining the care system, and improvement is every employee's responsibility.

There are essential leadership behaviors that can facilitate the positioning of the organization onto a safety pathway. At the same time there is no simple formula or set of operating characteristics that guarantee moving towards error-free care. Some key characteristics gleaned from highly successful organizations include active leadership participation in building a safety culture through relentless focus on safety in all leadership activities both at the Board and at the Front line level. Given the competing interests of complex medical institutions (particularly Academic Medical Centers) the focus of Hospital Boards on patient safety requires disciplined education to ensure that adverse events, organizational risk assessments, and reporting metrics are prioritized and given a central platform at all meetings. For the front line staff, visible leadership with regular "walk rounds" on patient care units creates an atmosphere where sharing patient incidents, de-briefings, sensitivity to local agendas, celebrating good safety "catches," and the use of stories creates a level of trust and modeling that is the essential floor for building the infrastructure that supports a safe healthcare environment. [29]

Physician engagement and alliances with physician leaders in developing safety competencies across clinical and supporting departments are necessary to build a model of behaviors that supports patient safety as the number one organizational priority. Several national organizations (Institute of Health Care Improvement, National Patient Safety Foundation) provide excellent opportunities to grow leadership skills and foster essential networks and problem solving from a broad range of colleagues outside of usual specialty-based continuing education. Harvesting ideas and strategies from disparate organizations validates the similarities confronting all medical leaders. From an academic point of view, patient safety offers an opportunity to build a portfolio of measurable outcomes within a medical center's community that can foster a career in patient care, teaching, and interdisciplinary clinical safety research.

Healthcare leaders need to be cognizant of the broad range of areas that comprise the core content of hospital safety. Each safety content area is evolving by national and international input through research, specialty society endorsement, adoption by regulatory and payment systems through formal vetting processes [30-32] in establishing best practice standards and metrics. Feedback loops from clinical experience about the unintended consequences of treatment guidelines, such as antibiotic overtreatment in Emergency Rooms with overly rigorous time standards for identifying pneumonia, result in changed or deleted pathways. Some safety areas, such as falls, do not have evidence-based standards that can reliably detect patients at high risk, thus many institutions have put in place universal fall prevention standards. Creating an error free safe environment is a work in progress.

A 49-year-old male patient was in the office with his Nurse Practitioner several months after chemo-radiation for Squamous Cell Carcinoma of the buccal mucosa with positive lymph nodes. The patient had a feeding tube, 25 pound weight loss and complained of low grade fevers, chills, night sweats, and generalized malaise for three weeks. His oncologist ruled out recurrent tumor with CT and MRI scans, negative chest CT for emboli, and normal ultrasounds of his lower extremities, an echocardiogram did not show vegetations and his blood work was non-specific. The NP reviews his medications. She asks if he needs a renewal of his fentanyl patch for mucositis. The patient had abruptly stopped using the patch (equivalent of 230 mg morphine) when his mouth symptoms began to improve a month earlier. She diagnosed him with narcotic withdrawal and restarted oral narcotics on a long term taper. The symptoms resolved within 24 hours.

Medication errors are the most frequent errors in the hospital environment and narcotic dosing issues are common. While computer automated ordering and electronic systems have reduced medication mistakes they have not eliminated the need for careful medication reconciliation. Drug interactions, proper dose calibrations, subtle and confusing side-effects are frequently misattributed to the progression of clinical disease, especially in cancer patients, and often go unrecognized.

Hospital acquired infections (HAI) are sentinel indicators of the level of safety management in all hospitals since they are preventable with meticulous hand hygiene and checklists of bundled care processes. Pronovost published the results of a study in the state of Michigan showing that a CLABSI (Central Line Associated Bloodstream Infection) bundle plus a comprehensive unit based safety program (CUSP) sustained reduced infection rates in ICUs across the state. [33] The checklist of steps to prevent line infections (1. hand hygiene; 2. maximum barrier precautions upon insertion; 3. chlorhexidine skin antisepsis; 4. optimal catheter site selection; 5. daily review of line necessity) has been extended to many other conditions. Ventilator associated pneumonia, urinary catheter related infection, early sepsis recognition, wrong site surgery, anticoagulation measures, glycemic control, delirium recognition, stroke management, patient identification, pressure ulcers, and surgical site infections have used checklists and bundled processes with success. The paper and pencil methodology serves as a force function of prescribed activities for care team members in "all or nothing" engineered activities around key common high risk activities in patient care. [34, 35] The simplicity of the checklists belies the commitment necessary to multidisciplinary care and non-hierarchical communication.

Several areas have been resistant to measures to ensure patient safety and some represent new "frontiers" of the patient safety movement as it matures. Hand hygiene, ironically one of the fundamentals of safe care, has a dismal track record of compliance throughout the healthcare industry. Even with the advent of ubiquitous topical alcohol-based solutions there is still substantial room for improvement. The iatrogenic transmission of infectious pathogens remains a cause of serious complications. For patients with various degrees of immunosuppression or subject to potential bone marrow toxicity and low white cell counts, such as most cancer patients during the active phase of treatments, iatrogenic infections can be fatal. Some hospitals have taken substantial measures, from sanctioning providers with loss of privileges to videotaping hand washing sites to ensure 100% compliance.

There are additional patient safety efforts that have demonstrated effectiveness. Many are being embedded in the practices of neonatal intensive care units, operating rooms, blood banks, critical values for laboratories, new strategies to reduce radiation exposure, reduction of violence in behavioral health, and improving diagnostic precision in outpatient departments and emergency rooms. Simulation centers are becoming an integral part of team training. Videotaping cardiac arrests on sophisticated computerized dummies to giving feedback to senior attendings [36] while interviewing actors offers an expanding repertory of tools for medical centers in safety and education. Rapid Response Teams of highly trained nurses, respiratory therapists, and clinicians have become standard throughout hospitals. Calls from staff and family members because of physiologic changes to "Mrs. Jones just doesn't look right" (the most common reason for the calls) have had a measurable effect in reducing cardiac and respiratory arrests, reducing ICU stays, and mortality as well as psychological support for the front-line staff. Immunocompromised oncology patients on complex medication regimens benefit from this "early warning system" responsiveness to subtle behavioral or clinical changes.

With the introduction of more widespread palliative care expertise [37] for patients with chronic illnesses, earlier more nuanced end-of-life discussions are beginning to have a positive effect on changing the healthcare institution's focus on a patient's personal goals of care. Sharing values and increasing awareness, with training and teamwork in communicating difficult issues, palliative care can have a broad influence on the culture of caring and safety within a hospital and its community. Thoughtful calibration of diagnostic tests and treatments without the fear of abandonment, plus full support for both the patient, their family, and caregivers, is part of the "halo" effect of a strong palliative care programs. This is particularly relevant for oncology patients where discussions of goals and resuscitation are frequently neglected. [38] Many hospitals have adopted Schwartz Rounds where complex psychosocial issues are discussed across disciplines allowing emotional, psychological, and medical issues to be aired. [39]

Developing the proper metrics [40] for improvement in safety (and quality) is a management priority for leadership. Administrative and financial datasets and manual chart reviews have been used as less than perfect proxies to provide report cards of performance. Electronic Health Record (EHR) data hold the promise of seamless real-time data monitoring of important processes and outcomes. To achieve balanced measures that are enablers of improvement requires a significant financial and sophisticated leadership investment to customize and maintain the EHRs sufficiently to retrieve actionable data over time. Real-time decision support, order sets, preferred care pathways, and "opt-out" analysis are additional tools that can be built into electronic systems. CEO's need to balance health "big data" analytics with the sometimes overlooked insight that not everything that matters can be measured. Technological "solutionism" [41] is a cultural phenomenon that is under-appreciated. Substituting technological fixes and data for a high touch profession is fraught with consequences of deepening patient and staff dissatisfaction and alienation.

The discipline of patient safety requires new knowledge applied to the delivery of patient care that supplements and leverages the medical content knowledge that is the basis of the expertise of clinicians, nurses, pharmacists, respiratory therapists, and so on. [42] Investment in a patient safety officer and patient safety administrative support allows organizations to continuously learn improvement science and incorporate the principles of patient safety. The orientation of physician's education has relied on individual decision-making and personal accountability with a lack of teamwork and collaborative care in the long apprenticeship and socialization process from medical school through post-graduate training. The traditional morbidity and mortality conference has reinforced the notion that errors and mistakes are personal defects and are rarely seen from the contemporary view of errors evolving from system issues. This fundamental shift in view recognizes that errors are the result of the confluence of failure points in complex processes. These processes usually have multiple upstream inputs that influence the proximate or "sharp end" cause of an error. [43]

The journey from individual blame and evaluation of errors or adverse events to a system view is foundational for a healthcare institution. Medical organizations and their departmental structures are hierarchical and function in a mode of authority and power. A systems view is frequently alien to a leader's or clinician's value system. Most organizations are adept at finding someone to blame for an error. Moving into the new paradigm of systems thinking of medical errors requires a personal and organizational transformation that is fundamental to the success of creating an ultra-safe organization. In addition to internal departmental silos and professional training issues, many external stakeholders from the tort system, to reporting requirements to state boards, state, and other regulatory agencies, plus omnipresent media attention, are potent countervailing forces to transparency and safety. As the systems model develops a national constituency through advocacy, practice, and familiarity, there is a justifiable concern that individual accountability should not be lost as a core professional responsibility. Every adverse event is not a systems issue. [44] An algorithm has been developed that balances systems issues and personal accountability in a usable framework. [45] A more subtle concern is the introduction of a systems approach layered on a resistant culture of blame.

A hospital network launched a Just Culture initiative to support its broad patient safety goals of harm-free care and specifically to increase reporting of adverse events and near misses. National safety leaders were brought in for educational sessions and an extensive public relations campaign blanketed the organization with the message "the single greatest impediment to error prevention is that we punish people for making mistakes." A nurse gave the wrong medication to a patient in an Emergency Room and was reported to the state licensing board and terminated.

The basis of developing a safer medical institution is firmly grounded in the insight that humans are fallible and errors are inevitable. Error reporting, investigation, and analysis then become the basis for a continuous learning environment. The precondition for error reporting - including the majority of errors that did not cause an adverse outcome - is dependent on a safety culture that is fair, open, and not based on punishment. Safety culture is a facet of organizational culture defined as an "emergent system of meaning and symbols that shapes how organization members interpret their experience and act on it in an ongoing basis" [46].

While evidence-based care is one aspect of quality, healthcare is delivered in a complex environment by multiple team members in complicated layered processes that have many moving parts. Safety is ensured by both the fidelity of the processes based on formal policies and procedures and a front-line staff that constantly adapts and adjusts to breakdowns in the delivery systems when the processes do not work and complex patient situations create confusing or new responses. As Reason has pointed out, when these gaps are aligned a harmful event can take place. [47]

Fostering a safety culture requires leadership alignment of the disparate safety initiatives into a coherent whole. Walk Rounds on patient units and clinics with time to openly discuss problems and system "failures" have been found to be powerful symbols of leadership commitment to patient safety by the front-line workforce. Patient stories carry the messages of care, errors, and learning to everyone in an organization and simultaneously transmit the charged emotional context that is missing in the standard lectures on regulations and safety procedures. The story of Josie King at Johns Hopkins who died from dehydration overlooked by the clinical staff, and Betsy Lehman at Dana Farber Cancer Center in Boston who received excessive doses of chemotherapy, have been told thousands of times and become the pivot points of organizational transformation. The death of Libby Zion from an unrecognized medication interaction in a New York hospital in the 1980s triggered a focus on resident's work hours, fatigue, and errors. Narratives condense and transmit meaning throughout organizations. [48]

While a culture shift towards system knowledge, a Just Culture [49] model proposes that since human "condition cannot be changed, the only hope for safer care lies in a relentless focus on improving systems of care." [50] This is accomplished through building institutional competencies in teamwork/communication, process improvement, and continuous learning.

Communication and teamwork gaps are a common denominator in adverse events, and can be magnified in today's multidisciplinary, highly sophisticated practice of oncology. Given the vast number of interventions, number of people involved in caring for individual patients, and technological inputs, shift changes, and hierarchies between staff and within departments, a great deal of focus has been on incorporating formal structures to ensure the accurate exchange of information while supporting team integrity. From aviation, Crew Resource Management (CRM) evolved to flatten the cockpit hierarchy and allow all crew members to speak up. This has evolved into a medical equivalent using time-outs in the operating room where a force function creates a pause, allowing everyone involved to speak up. Huddles are used in ambulatory care to prepare and anticipate complex or compromised patients. TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) developed by the Department of Defense is a systematic formal approach to team development, efficiency, and culture change that many institutions have used to improve performance in collaborative groups. SBAR (Situation, Background, Assessment, and Recommendation) has been developed to reduce the variation in handoffs between clinical groups in different circumstances to mitigate the misinterpretations and lack of clarity which commonly cause errors.

Organizations have found different paths to a systematic approach to process improvement. For many it has been a combination of approaches using Lean strategies borrowed from the Toyota production systems to continuously remove defects and "waste" from systems of care. All employees are both trained and empowered to be critical thinkers about the systems they are embedded in and have the knowledge to carry out change trials to improve processes. Six Sigma is another methodology to reduce variations in patient care and supporting processes that is being adapted to healthcare from the corporate world. It applies a practical disciplined approach to both analyzing processes and making changes. The Institute for Health Care Improvement (IHI) has promoted a widespread methodology of small cycle changes, measurement over time, and replication that - combined with organizational psychology and spreading innovations - can be a powerful staff motivator and motor of organization innovation. [51]

The goal is to create a learning organization focused on the particular needs of individual patients. Successful organizations engineer continuous feedback loops that use information on variations in patient care and adverse events to continuously improve their care processes. From a safety point of view, among the many data points organizations are monitoring, from medication issues to falls, from hospital-acquired infections to unplanned readmissions, adverse events are analyzed by multidisciplinary teams using formal root case analysis (RCA) or mini-RCAs (unplanned readmissions) to systematically go beyond the immediate "event" into the confluence of contributing factors. The overuse of Intensive Care for many terminal oncology patients has pushed hospitals to both expand palliative care and to re-engineer advanced care planning into oncology clinics at the time of diagnosis. The Veterans Administration has developed a safety leadership group developed by Jim Bagian, a prominent leader in safety, that trains representatives from all VA facilities in an informed and disciplined evaluation process. One result is on-site expertise in event analysis and the ability to connect the deeper issues that underlie most harmful events. Another benefit is that a central repository of events and analysis is shared across the largest healthcare system in the country.

The content area of patient safety for healthcare institutions is broad and deep and is growing at a significant rate. Committed leadership is the pivot maintaining focus and supporting the diverse efforts that ultimately change long-standing attitudes and practices. A platform for durable cultural transformation can develop where patient safety is lived through the attitudes and behaviors of the entire workforce.

The future of safety in healthcare and cancer care institutions Despite the challenges and uncertainty of healthcare reform, organizations are in different stages of adopting a value-based population model of delivering healthcare. Driven by better aligned payment and regulatory inputs, quality and safety performance characteristics and metrics are an integral part of the new conceptual framework. Patient safety, harm-free healthcare, is the core strategic goal for several leading organizations. In this context, healthcare leaders at the cutting edge of patient safety along with their regulatory and policy-maker counterparts are both articulating and creating what a successful organization can look like under new operating principles.

The concept of a High Reliability Organization or HRO has emerged from the studies of other industries. (Failure in the context of an aircraft carrier, aviation industry, and nuclear power is catastrophic.) Reliability is defined as "failure free performance over time." [52] From the influential work of Weick and colleagues, an outline of the key characteristics of how complex high-risk organizations stay safe has emerged. An environment of "collective mindfulness" exists where all healthcare workers report unsafe conditions and potential threats. This data is used by the organization to continuously monitor its environment, make changes and eliminate risk points before they become "events." Frequently these are "weak" signals of potential threats to safety and are prized as intelligence to be analyzed and acted upon continuously and proactively. [53]

The reliability principles developed by Weick and Sutcliffe form a capabilities backbone for complex socio-technical organizations to maintain failure free performance over extended periods of time. The first principle in High Reliability Organizations (HRO) are a preoccupation with failure. HROs are never satisfied with current performance. "Nothing recedes so fast as success" is their mantra. They are aware that latent threats can develop with only subtle manifestations. The second principle is the recognition that over-simplification of complex processes can lead to mistaken evaluations. Alarm fatigue is a recurrent problem in responding to a patient's physiologic changes in the increasingly monitored hospital environments. This socio-technical interface requires extensive training and sophisticated individual patient calibration. The third principle is an extreme sensitivity to front-line operations. Rapid response team activation based on subtle behavioral changes (delirium) is an example of a potentially "weak" signal rapidly escalated and handed off to an expert team. Overlooked early sepsis on an oncology unit to an emergency room resulting in delayed treatment has prompted guidelines and checklists to increase vigilance for this potentially life-threatening clinical syndrome. The fourth principle is resilience. The operating principle of resilience is keeping the undesirable outcome contained and preventing its propagation. This openly acknowledges that events will happen and they are analyzed for what they have to teach the organization. Bringing in expertise at any level is the fifth resilience principle. It acknowledges that appropriate decision-making in complex high-risk organizations resides with content experts and not necessarily with senior managers. Centralized command and control organizational models frequently delay responses and propagate problems since content expertise is widely dispersed.

The HRO model represents an institutional and industry goal. The healthcare of 2014 has sporadically and incompletely incorporated the principles of resilience and failure is still accepted as the cost of doing business. Chassin and Loeb [54] suggest an incremental approach to HRO development around the HRO framework. They base their three-pronged approach on "(1) A leadership commitment to zero patient harm, (2) the incorporation of all the principles and practices of a safety culture throughout the organization, and (3) the widespread adoption and deployment of the most effective process improvement tools and methods." They detail a multilevel approach to organizational change based on new organizational skill acquisition from the different disciplines outlined above, along with leveraging medical expert content knowledge to develop an HRO.

The challenge of HROs comes at a time when there is increasing awareness of the depth of significant structural impediments within the healthcare industry that have to be addressed to realize a team-based collaborative and integrated delivery system that can produce ultra-safe care over extended periods of time.

Substantial healthcare workforce issues relating to physical and psychological threats impose a penalty on an essential pre-condition for a supportive safety culture: engaged and activated employees. There is a direct linkage between worker safety and patient safety in a recent report from the prestigious Lucien Leape Institute of the National Patient Safety Foundation. It is widely known that healthcare workers are subject to injury at substantially higher rates than other industries.

Both the nursing and physician workforces report increasing dissatisfaction and burnout resulting in high turnover and early retirement. The industry-wide problems of production pressures, toxic socio-cultural norms, hierarchies that impede speaking up and reporting, regulatory burdens, tolerance of bad behavior, and physical harm were reviewed. Lack of respect from management and physicians was the common denominator. The Institute called for fundamental changes in how the 18 million member healthcare workforce is treated based on new normative behavioral expectations in the healthcare industry. [55]

Resistance to safety improvements and the slow pace of safety uptake have been the subject of several studies and commentaries. [56] Physician autonomy and individual accountability that define the professional culture of medicine is felt to play a significant role. Problem solving in complex interdependent clinical domains by departments with different perspectives in a piecemeal approach prevents systemic integrated safety solutions while apparently addressing the issue at hand. Some notable exceptions suggest solutions. Anesthesia went through a remarkable change in the 1980s, motivated by high rates of complications and claims. With outstanding leadership, eliminating variation through standardized care protocols, and introducing engineering concepts to solve human technical interface issues and founding its own safety institute, Anesthesia's safety record became the best in the industry. The issue of "who is your anesthesiologist" became moot. The Northern New England Cardiac Group (multiple groups from different organizations) collaboratively auto-critiqued practices over time and achieved outstanding sustained outcomes.

Individual organizational contexts shape the progress, success, and failure of patient safety initiatives. Programs introduced without careful planning, "project fatigue," lack of integration across disciplines and clinical departments, relentless production pressures, lack of congruence between initiatives such as cost reduction and safety and patient satisfaction and efficiency, results in degradation over time through loss of focus. For organizations to successfully move towards a goal of high reliability the implementation of a set of "fundamental and wide-ranging changes in care delivery processes, technology, people, structures, and cultures" is required. [57] Transformational change requires transformational leadership to create an institution-wide supportive environment for a High Reliability Organization.

Oncologic care is a paradigm of complex interdisciplinary diagnosis and treatments comprising many disciplines over extended periods of time. Patient safety principles are at the core of creating sustained excellence for an expanding population with new therapies and at the same time recognition that there are limitations to treatment. The doctor as patient offers a window into the complex technical and emotional cancer world that patients enter and in some ways is unknowable unless you have been there. [48]


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