Chapter 12 Raymond L. Fowler Regionalization of emergency medical care has become the rule over the last few years. A complex process from a clinical and a political perspective, the desired result of these efforts is improved patient care in those areas addressed by these efforts [1]. The Institute of Medicine in 2006 promoted regionalization as a means of improving patient outcomes and reducing costs [2]. Indeed, regionalizing specialty referral centers improves patient outcomes. For example, solid evidence exists that regionalized systems of care for trauma patients significantly improve patient outcomes [3–13]. Similarly, studies also demonstrate outcome improvements for victims of ST-elevation myocardial infarction (STEMI) patients in many systems [14–17]. The design of the system is vital to its success, and that success is highly dependent upon the ability of the designers to examine the entire system of emergency patient care. The design of a regionalized system of care – across the spectrum of clinical presentations – must focus on every aspect of the patient’s complex journey through the emergency medical care system, identify any “weak links,” and target these areas for improvement. The need for regionalization may not be fully understood by individuals who do not understand the intricacies of the entire emergency medical care system, even though many of them work within the system. Many tend to operate within organizational silos, and thus integrating their work with other providers must begin by breaking down system barriers. The emergency medical care system in a nation is a broad network that encompasses the component EMS systems that make it up. The system encompasses the entire care pathway that the patient must traverse in the journey resulting from an out-of-hospital care activity, and all components of care of the Emergency Medical Care System Circle (Figure 12.1). In contradistinction, we typically speak of an EMS system as only the out-of-hospital component of the patient’s care. The individual components of the emergency medical care system vary widely in their capabilities and responsibilities. For example, both ground and air response may be quite variable in clinical care abilities [2]. Hospitals may vary significantly in their abilities to care for severely ill or injured patients. Patients often require a high level of care that is unavailable at a local level to optimize outcomes. The early identification and “care mapping” for such patients form the basis of the need for an integrated, prospectively designed emergency medical care system through regionalization of medical care. EMS medical directors must be the leaders in bridging the many disciplines necessary for the creation and maintenance of a broad system, addressing actively the need to educate others on the entire spectrum necessary for system design and improvement. The importance of the EMS medical director in accepting this responsibility with a broad perspective cannot be overstated. Success in efforts to regionalize facilities through categorization and designation has varied historically, first noted some 30 years ago as a pressing public imperative [18,19]. Only when all participants are committed to focus on the goal of improved patient care, across the spectrum of the variety of human clinical presentations, can the necessary system improvements begin to occur. It is useful to consider an example of a case that might occur in an emergency medical care system on any given day. The dispatcher in a seven-digit public safety answering point (PSAP), with no 9-1-1 number available, receives a call for emergency medical help. The caller tells the dispatcher that a child is choking and turning blue. The dispatcher in this rural setting, not trained in giving prearrival instructions, replies, “I’m sending someone right now!” A first responder unit and a transport ambulance are quickly dispatched. A total of 12 minutes is required from the initiation of the call to the initiation of care. Upon arrival of the EMS providers, the child is pulseless and apneic. The initial resuscitative efforts return a weak pulse. The transport ambulance arrives, and after a 20-minute scene time, their protocol is to transport to the nearest facility. The transport interval is 15 minutes. The closest hospital facility is a low-volume ED that rarely cares for critically ill pediatric patients. Though the ED staff quickly gears up to provide the best care that they can, a lack of pediatric-specific equipment at the hospital delays definitive airway care and IV placement for the hypotensive, unresponsive child. A decision is made to transfer the child to a pediatric regional referral center. Elapsed time from arrival at this facility to the call for transfer is 40 minutes. The pediatric tertiary center insists on sending its own transport team for the child and a 1-hour response time ensues. This interval is followed by a 45-minute scene time at the local hospital and a 50-minute transport time back to the tertiary center. The child is admitted to the tertiary care center’s pediatric intensive care unit, exhibits evidence of severe anoxic encephalopathy, and dies 3 weeks later. The EMS medical director for the local emergency medical care system (EMCS) reviews this case and initiates the formation of an oversight body to improve the system. Quality improvement processes occur and each entity, from the dispatch agency to the transport team, concludes that it did the best it could have done at the time in this setting. The initial conclusion was that the outcome in this case was unavoidable and most unfortunate. This assessment is of little solace to the child’s family. They realized that it was 12 minutes from the time of their call for help before their child was ventilated. They saw that it took 4 hours to get their loved one to a tertiary care facility. And they felt that if the original ambulance had turned right toward the pediatric hospital 30 minutes away instead of left toward the local hospital – at one crucial intersection – maybe the outcome would have been different. How could regionalization have helped this child? The EMS medical director, looking at the entire spectrum of care provided to this patient, saw many areas for potential improvement that were then set before the oversight committee for consideration. The group saw that each component reflected individual “silos” that barely communicated. A process was initiated that examined every section and opportunity for care within the context of the whole system. Deficiencies were identified and proactive plans were made for maximizing that care on a regional basis, across the spectrum. The committee, led by the EMS medical director, set out to form a truly integrated emergency medical care system for the region. Regionalization is the formation of a coordinated system of care across a geographical area that combines all necessary components to optimize patient outcomes. This includes out-of-hospital components, in-hospital components, and public health components. The goal of the effort is both to facilitate the provision of quality patient care and to assure the overall economy of the system through utilizing appropriate resources within the region, coordinating overall care to focus on patient outcomes. Categorization is the classification of facility capabilities against accepted standards. Categorization should be initiated before formal facility designation occurs. Designation is the formal selection for patient referral and transfer by an organized body that has the authority to do so, typically both governmental as well as specialty designation bodies. A minimum set of standards exists for the various specialty designation areas that a facility must meet to become designated as a specialty receiving center. The time-critical diagnosis system is the concept that a coordinated, integrated emergency medical care system can use to treat those diagnoses that are truly time critical. Clear evidence demonstrates that severe trauma, acute ischemic stroke, and STEMI outcomes can be improved by specialty care at regional referral centers designated by an accrediting body. The time-critical diagnosis concept seeks to avoid the creation of three separate systems (stroke, trauma, and STEMI) within a state or region, since the individual components of the system (EMS, local and regional hospitals, and various bureaucratic and oversight entities) play essential roles for all of these clinical cases. It is far more appropriate and cost-effective to coordinate all the critical cases within the emergency medical care system under a common banner of time-critical diagnosis. This allows resource sharing and coordination at many different levels and decreases duplication. Once formed, the combined time-critical diagnosis body has a significantly more powerful position in the political arena than do individual efforts. Bypass is the decision to avoid transport of an out-of-hospital patient to a particular hospital facility when transport to a more distant facility will provide more optimal care. The decision to bypass the closer facility is made in the setting of clinical time-critical diagnosis cases in which care at the more distant facility – such as a stroke center, a STEMI center, a trauma center, a pediatric center – will most likely improve the patient’s outcome. Diversion is an act taken by a hospital facility that informs field providers that transport to that facility should not occur. Diversion most commonly occurs when the patient traffic in the emergency department of that facility is of such a magnitude that additional EMS traffic could endanger either the current patients in the facility or the patient being transported. Diversion is commonly defined as an action that is allowed as a courtesy from the EMS medical director of that EMS system [20]. In the past 70 years, the US military made most of the advances in the care of critically injured patients despite the fact that civilian accidental injuries occurred at an alarming rate [18]. Care of the severely injured in the military sector progressively improved through World War II and both the Korean and Vietnam conflicts, mainly through the prompt, judicious transport of the critically injured to centers specializing in trauma care. The lessons learned in the military sector, however, were slow to translate into the civilian sector. In 1961, a “shock-trauma” unit was established at the University of Maryland to study shock in humans, followed by the first civilian trauma unit at Cook County Hospital in Chicago in 1966 [19]. This first trauma unit began promoting the concept of regionalization of trauma care in the civilian sector. The publication in 1966 of the far-sighted study from the National Academy of Sciences, Accidental Death and Disability: The Neglected Disease of Modern Society [21], was the seminal event that fostered the regionalization concept and modern civilian trauma care. The report detailed the problems within the medical care system of the day that contributed to the high morbidity and mortality due to trauma in the US. A few selected quotes from this 48-year-old report are useful to review today. It is useful to look at the progress made in the emergency medical care system era today, and to examine the steps that were required to produce many of the positive results that have been seen. Congress paid attention to the report and began to address some of these shortcomings by directing funding into the Department of Transportation (see Volume 1, Chapter 1). Late in the 1960s and early into the 1970s, the conceptual design of a “systems approach” to trauma and emergency medical care began to emerge in some areas of the country. Programs emerged that targeted specific types of patients such as cardiac, trauma, burns, and spinal cord injuries. Illinois founded the first regionalized system in 1971 [22]. The Emergency Medical Services Act of 1973, signed into law by President Nixon, funded a nationwide shift from funeral home-based ambulances to a professional system of response and transport. A major goal of that federal grant program was regional EMS systems development on a national scale [23,24]. As the EMS Systems Act became implemented, it quickly became apparent that a system of categorization of hospital capabilities was needed so that other health care providers – both out-of-hospital and transferring emergency departments – would be better informed about optimal referral of patients. The need for standards for specialty referral centers was quickly seen to be necessary. Trauma centers needed specialty teams ready to perform key interventions up to and including major surgery at all hours. Stroke center and STEMI center accreditation emerged, providing the requirements that these centers must be able to administer appropriate therapy to promote restoration of blood flow promptly. Indeed, as trauma became recognized as an emergency of critical injury, the care of stroke and heart attacks became recognized as “acute vascular emergencies” requiring prompt specialty care. Formal designation of facilities by authorized bodies has followed. This designation process ensured that the categorization of facilities was accurate and that minimum standards were being met. In states that did not mandate those minimum standards, care was often found to be mediocre when compared to a formal process, though it was also found that any attempt at organization was better than no system at all [3–13,25,26]. Regionalization has followed the process of designation, requiring growth and change on the part of EMS providers. Enactment of state and/or municipal laws and regulations provides authorization for lead agencies to oversee processes within the emergency medical care system. For example, in New York State in 1998, facilities in half of the EMS regions were categorized based on guidelines established by the State EMS Council without formal state authority [27]. Since there was no legal authority to designate facilities, the process relied on voluntary participation that was uneven in some regions and non-existent in others [28]. Absent an authorized lead agency to carry out the process of oversight, it is important for the EMS physician to know that the risk of legal challenges against an emergency medical care system might increase. Designation often creates de facto monopolies by restricting the number of facilities allowed to participate within a given system, by requiring that certain standards of care be met prior to participation [29]. For example, the state of Texas (Administrative Code 157.133) requires that acute stroke patients be transported to the nearest comprehensive stroke center (CPC), primary stroke center (PSC), or secondary stroke center (SSC). If a PSC or CSC is within 10 minutes of the nearest SSC, the stroke patient will be directed to the PSC or CSC since more comprehensive care will be available at that center. In the absence of explicit authority, the designation process may be impeded by physicians, hospitals, or other special interest groups. Initially, system planners did not adequately address the need for explicit authority to designate trauma centers. Compounding this shortfall was the lack of federal funding for upgrading hospital facilities. Individual hospitals were expected to make costly improvements on a voluntary basis [18]. Since it was assumed that designation of trauma centers would promote the development of the regionalized emergency medical care system, attempts were made in the 1970s to organize such systems around trauma center development [30]. When federal EMS systems funding effectively ended in 1982, program initiatives and necessary legislative changes became the responsibility of individual states. Those responsible for developing or managing EMS systems found that in the absence of both federal money and legal authority, plans for regionalization through facility designation commonly failed. Many of the specialty referral center problems were caused by a relaxing somewhat of the originally strict criteria recommended by the American College of Surgeons and the development of Level II trauma center designations. The competition for designation as Level II centers among smaller community hospitals, and the litigation from this action, effectively halted development of the designations process altogether in many areas [31,32]. Concern regarding adverse economic effects (mainly the loss of patients) by those institutions not designated occasionally resulted in resistance by hospital administrators and physicians to both categorization and designation. It was noted that fewer than 10% of all trauma patients actually required trauma center care, and thus the actual loss of patients from non-designated hospitals was modest [18]. These same concerns are evident more than two decades later in the discussions about categorization and designation for acute ischemic stroke and STEMI. However, increased competition among facilities that have geared up for multispecialty critical care has increased the desire among these facilities to have EMS patients with these conditions transported to their facilities. At this writing, in the county of Dallas, Texas, there are 15 facilities that receive emergency 9-1-1 EMS patient transports from within the county. All 15 have percutaneous coronary intervention capability and are certified chest pain centers. Also, at this writing, 13 of these facilities either are certified stroke centers or are in the process of application to become certified. Thus, the competition for EMS emergency patients with these two conditions in this geographical area is very high. Lead agencies with appropriate empowerment are important to a stable emergency medical care system process, as they oversee the planning, implementation, and operation of these systems, generally in the absence of serious legal challenge [33–35]. System development is much more difficult absent statutory and regulatory authority facility designation, establishing of regionalization processes, and overall system design. A branch of government with legislative authority to designate is best suited to serve as the lead agency.
Emergency care regionalization
Introduction
The emergency medical care system
A patient episode
Definitions
Historical background
Categorization and designation