Chapter 8 Robert R. Bass, Benjamin Lawner, Debra Lee, and Jose V. Nable In the United States, and much of the rest of the world, medical direction of EMS is today widely endorsed and recognized as an essential component of any EMS system [1–4]. However, this has not always been the case. In the landmark 1966 white paper Accidental Death and Disability, the Neglected Disease of Modern Society [5], the role of physicians in prehospital care was envisioned as that of potentially staffing ambulances to provide direct patient care, similar to the role that physicians play today in other countries, particularly in Europe [6,7]. While there were a few efforts in the US in the late 1960s, in places such as Columbus, Ohio, to engage physicians in providing prehospital care, these efforts largely gave way to the use of “physician surrogates” who soon became known as paramedics [8]. These providers were initially trained and supervised by physicians to provide advanced prehospital care, especially to victims of sudden cardiac arrest or trauma. Within a few years, national standard curricula were developed by the US Department of Transportation, which standardized the training of paramedics and included requirements for physician oversight of the education of paramedics and the care they provide in the field. Of note, the Emergency Medical Services Systems Act of 1973 made no reference to the need for medical direction [9]. When the EMS program at the Department of Health, Education, and Welfare (DHEW) subsequently developed the 15 essential components of an EMS system, they did not include medical direction as one of them. Despite these omissions, during the rapid development of EMS systems during the late 1960s and 1970s, medical direction of EMS became a de facto standard, especially for ALS providers. Although it was not considered one of the essential components, DHEW did eventually make medical direction for ALS a requirement for awarding grants. In 1988 the National Highway Traffic Safety Administration included medical direction as one of the ten essential components for state EMS technical assessments [10]. The EMS Agenda for the Future in 1996 identified the need for medical direction for all levels of EMS providers, a principle that was thereafter incorporated into the US Department of Transportation’s national standard curricula for EMS providers, including those for EMTs. Medical direction remains a component of the National EMS Education Standards today. Over the past 40 years, the role of the EMS medical director has evolved and has become more clearly defined through the efforts of the National Association of EMS Physicians, the American College of Emergency Physicians, federal agencies, and national organizations to encompass all aspects of an EMS system [1,3,4]. Peer-reviewed journals, including one dedicated solely to prehospital care, have enhanced the science behind the provision of care to patients in the out-of-hospital setting, including the roles [11] and effectiveness [12,13] of an EMS medical director. Additionally, the cognitive and skills requirements for EMS medical directors have been refined through the publication of textbooks on EMS medical direction, guidelines for EMS fellowships, and, more recently, the development of an American Board of Medical Specialties (ABMS) approved subspecialty in EMS. The role of the EMS medical director over the past decade has continued to evolve and, more recently, may be accelerating. The events of September 11, 2001 have drawn many EMS medical directors into a much more active role in disaster planning and response. More recently, H1N1 and other emerging infectious diseases have required medical directors to address issues ranging from EMS provider safety and surge mitigation, to the storing and dispensing of medical countermeasures. Recent efforts to utilize EMS providers in communities to address a broader range of medical care and public health issues have engaged EMS medical directors in discussions and planning on how to safely and effectively provide oversight for these emerging EMS roles. EMS medical directors have traditionally felt responsible for the emergency care provided in their communities and, therefore, have taken a public health- and population-based approach to what they do. These new and expanded roles for EMS will necessitate a reconsideration of the education and preparation of EMS providers, and perhaps medical directors, to take on these new roles and how to best ensure that EMS systems continue to function safely and effectively [14,15]. In the late 1960s and 1970s a relatively small group of dedicated physician mentors recognized the need for improvements in prehospital care to address major public health issues that were resulting in needless deaths. In cities such as Miami (Gene Nagal), Los Angeles (Michael Criley), Charlottesville (Richard Crampton), Baltimore (Peter Safer), Columbus (James Warren), and Seattle (Leonard Cobb and Michael Copass), they advocated for trained and supervised prehospital providers to care for patients with sudden cardiac arrest, trauma, and other life-threatening emergencies. These physicians were well recognized in their chosen specialties but, at the time, it is doubtful that they recognized that they were laying the foundation for what would eventually become a formal subspecialty in EMS. Over the ensuing years, as systems were required by grants or state rules to appoint EMS medical directors, a number of physicians assumed the role. Some did so out of interest or a sense of community service, others perhaps because they were asked to take on responsibilities that no other physician was willing to assume. Many of these physicians served admirably, but moved on. However, as the decades went by, an increasing number of physicians became EMS medical directors because they were genuinely interested in prehospital care. Many were (and still are) former EMS providers who wanted to get back on the street and take on the responsibilities of an EMS medical director. Over time these physicians came to view their medical director roles as the practice of EMS. A little over 100 physicians met in Hilton Head, South Carolina, in 1985 and subsequently formed the National Association of EMS Physicians. Several decades later, with the support of the American College of Emergency Physicians and other national specialty groups, they successfully petitioned the American Board of Emergency Medicine and the American Board of Medical Specialties to establish a subspecialty in EMS. As with the specialty of emergency medicine, it is likely that the growth in the number of EMS subspecialists will not meet the demand for some time. There will continue to be challenges in recruiting EMS medical directors, particularly when a position is uncompensated and/or in a rural area. We should anticipate that EMS subspecialists will initially be employed by larger municipal systems, academic centers, state and regional systems, and national commercial providers. It is therefore likely that, for some time to come, we will continue to see physicians serving as local EMS medical directors who are not EMS subspecialty physicians. In the United States, the regulation of health care, including EMS, is by and large the responsibility of the states. While there may be national consensus on the need for medical direction, there is significant state-to-state variation on the legal requirements for it [16]. States generally require medical direction for ALS, but there is considerable variation in the requirement for medical direction at the BLS level. Additionally, the role of the medical director and his or her qualifications vary from state to state (Box 8.1 contains a list of generally accepted qualifications for an EMS medical director). There are some states in which the state EMS agency has limited or no statutory authority over BLS providers and, therefore, even if they wished to mandate medical direction at the BLS level, they lack the authority to do so. Some states are also challenged with insufficient numbers of physicians willing to take on the role of the EMS medical director, particularly in rural areas [17]. State laws and rules significantly affect the role of the medical director. Most states require a medical director to be engaged in education, credentialing, protocol development, and quality assurance. However, depending on the state, these functions may be performed variously at the local, county, regional, or state level. It is important for a medical director to be cognizant of the state laws and regulations for medical directors as well as the liability protections that may be provided through state law. Additionally, medical directors must be cognizant of federal laws and regulations that can affect their role and responsibilities. Over the past four decades, the medical knowledge base and skills set required for EMS medical directors have been increasingly well defined. There are, however, other skills that are essential to the success and longevity of an EMS medical director, including, among others, leadership, administrative, and political skills. By the very nature of their role, EMS medical directors must be able to develop a vision, articulate it, and then effect change. Every EMS system poses its own unique combination of challenges whether it is a state, local, air, ground, fire-based, third-service, private, volunteer, rural, urban, BLS, ALS, or critical care system. It is the task of the medical director to recognize these challenges and effectively manage them. While the role of an EMS medical director may have been increasingly well defined and standardized at the national level, the authority and resources provided to an individual medical director by a given system or service most certainly have not. It is not uncommon to find a medical director with the title “medical advisor” and/or with limited authority. Many medical directors lack response vehicles, communications equipment, or staff support. The title, authority, compensation, and resources provided to a medical director should be defined in a formal contract or job description and must be appropriate for the service or system that they serve and be commensurate with their responsibility for the patient care that is provided (Box 8.2). A recent study suggests that EMS systems with engaged and compensated medical directors were more likely to have prehospital cardiovascular procedures in place [18]. Volunteer EMS providers are less likely to have recent contact with their medical director than their counterparts in hospital-based and county/municipal services [19]. In most EMS systems, indirect medical oversight encompasses the majority of a medical director’s activities and responsibilities. It is the process through which medical directors influence the practice of prehospital medicine in their communities [1]. Credentialing of EMS providers, quality assurance and performance improvement (QA/PI), and protocol development are all examples of how medical directors engage in indirect medical oversight. Anyone in need of emergency medical services has the right to expect the highest quality evidence-based emergency medical care [20]. From the initial 9-1-1 call to the medical care rendered on scene and even at the hospital, medical directors have the opportunity to positively affect the emergency medical care that is provided to each patient. Each EMS system is unique, and the medical director is responsible for providing clinical leadership that is tailored to the community’s needs. The delivery of EMS is influenced by many factors including the health of the population, the availability of resources, and the proximity of acute care hospitals. Medical directors must have a nuanced understanding of system needs and resources and use that understanding to ensure the delivery of the highest quality prehospital emergency medical care possible within that community. This section discusses various elements of indirect medical oversight and highlights the corresponding responsibilities of the EMS medical director. The system medical director must understand and be able to articulate a comprehensive vision for EMS provider education. In most systems the educational requirements for the licensure of EMS providers will be established by the state. Over the past decade, states have increasingly been adopting the principles of the EMS Education Agenda for the Future: A Systems Approach [2], which espouses the use of national EMS education standards, national certification as a prerequisite for state licensure, and the accreditation of EMS education programs [2]. At the local level, the initial and ongoing educational requirements for EMS providers may be affected by the local system. System medical directors may require additional initial and ongoing provider education to address local needs and ongoing QA/PI activities. These medical directors are frequently engaged in providing medical oversight for initial EMS provider training and, in such situations, may have the opportunity to address these needs prior to state licensure. The medical director must have a strategy to ensure the retention of skills by EMS providers. An active continuing education program can address the challenges of knowledge and skills retention and ensure continued provider competency. Educational approaches are also essential to address QA issues such as deficiencies in 12-lead ECG interpretation or airway management, as well as the implementation of new protocols or the dissemination of the latest in evidence-based approaches to prehospital care. Other important components of indirect medical oversight include the verification of competency and credentialing. At its most basic level, competency equates with a provider’s ability to safely and adequately perform patient care. Competency is predicated on the provider’s ability to synthesize appropriate information, make effective medical decisions, and safely perform interventions. Credentialing is the process that grants an EMS provider the privilege to perform a prescribed role and specific skills within a service based on competency. A local credentialing process should include meetings with the medical director, chart reviews, field observation, and simulated patient encounters. The medical director should establish criteria for initial and continued competency and conduct regularly scheduled provider reviews. The issue of competency is particularly important with certain low-frequency, high-impact patient care skills such as endotracheal intubation. Opportunities for intubations have been declining and it has been well established in the scientific literature that competency in the particular skill of endotracheal intubation is especially predicated upon frequent practice [21–24]. In the absence of a clear national standard for minimum intubations, medical directors must develop an effective plan for maintenance of this core skill. Literature suggests that intensive physician oversight is associated with increased intubating proficiency [25]. Finally, the medical director must have the authority to address the issue of EMS providers who are deemed to be incompetent or impaired to such an extent that they pose a threat to the public. To address this issue, the local credentialing process must enable a medical director to immediately suspend or limit the privileges of an EMS provider and to develop a plan for remediation, if that is deemed appropriate. In such circumstances, there should be a system of due process that is available to the provider. Quality assurance and performance improvement efforts comprise a large portion of indirect medical oversight responsibilities. Medical directors must actively monitor both provider and system performance to achieve and maintain a high standard of patient care. Quality assurance ensures that performance is as it should be. Performance improvement monitors processes and outcomes in an effort to augment and improve the overall quality of patient care [26]. When deficiencies are identified through the QA process, the program must provide the necessary changes to the system and/or retraining and remediation of the providers. QA is not a punitive process. Indeed, a well-structured QA plan prescribes corrective action, elucidates root causes, and educates providers. Performance improvement is an effort to improve patient outcomes, which requires that EMS patient care records be linked with hospital outcomes. Recent advances that EMS systems have made in improving historically poor outcomes from sudden cardiac arrest are demonstrative of the positive effects of PI. Over the past decade, medical directors in a number of EMS systems have established comprehensive processes for monitoring sudden cardiac arrest outcomes while making incremental changes to improve the delivery of prearrival instructions for CPR and the quality of CPR on scene. With such PI efforts, outcomes particularly for witnessed ventricular fibrillation arrests have been reported to have risen significantly in a number of jurisdictions [27–32]. Quality assurance and performance improvement efforts may be performed in a number of ways. Retrospective activities include review of patient care reports, provider debriefings, incident reviews, and analysis of EMS data and outcomes. Concurrent activities generally include the monitoring of care in the field by the medical director, field training officers, or EMS supervisors, and through simulated patient encounters. Electronic patient care reports are increasingly more available, giving medical directors unprecedented access to both the patient care reports and system data. Additionally, electronic summaries from monitors/defibrillators permit a detailed analysis of vital data, such as CPR compression density and depth and the timing of critical interventions. The widespread proliferation of waveform capnometry affords a similar level of patient care surveillance. Providers now can confirm endotracheal tube placement with near 100% accuracy and immediately recognize tube dislodgment or migration. Incorporating new technologies and using electronic patient care reporting establishes a vital link between patient care and the QA/PI processes. System benchmarking is another useful tool in the QA/PI armamentarium. The ability to do benchmarking has markedly improved with the development and availability of electronic patient care reports and the establishment of the National EMS Information System (NEMSIS), which defines EMS data elements and is building a large repository of EMS data from all across the country. Benchmarking through NEMSIS, and other large databases such as CARES, enables medical directors to evaluate their systems against a template of system, clinical, and patient outcome data. In 2008 a position statement published by the US Metropolitan Municipalities EMS Medical Directors called for the development and use of patient-centered measures of system performance. Potentially useful clinical benchmarks include the administration of aspirin for suspected cardiac chest pain, minimization of on-scene intervals for victims of penetrating trauma, and the use of non-invasive ventilation for respiratory failure [33,34]. Finally, QA and PI activities must include access to outcome data from hospitals. Patient outcomes are essential to understanding how prehospital interventions affect patient care. While prehospital data might indicate an increase in the return of spontaneous circulation, this is not the same as the percentage of patients who survive to hospital discharge and are neurologically intact. Patient care outcomes are affected by both prehospital and hospital care. The medical director must consider the entire continuum of care when evaluating the quality of care delivered to patients served by the EMS system. Field clinical supervision by the medical director is sometimes viewed as a component of the QA/PI processes but, in fact, it is much more. Medical directors in the field have an opportunity not only to assess the performance of providers and the system, they have an opportunity to mentor, engage in hands-on patient care, and learn firsthand about the challenges faced by providers [1,7]. Medical directors who are active in the field uniformly report that the time that they spend on the street is not only productive, it is one of the most enjoyable aspects of their jobs [12]. Many medical directors today functioned as EMS providers at some time in the past. This is a benefit in preparing a medical director for field clinical supervision. Medical directors who lack that experience should invest some time in getting oriented to “life on the street.” First and foremost, there are safety issues that must be considered as well as the many formal and informal rules and protocols that must be followed. Medical directors who understand these issues are able to insert themselves seamlessly into an incident and will garner significant credibility with EMS providers. Medical directors can perform field clinical supervision by riding with supervisors, but there are limitations to this approach. It is preferable for a medical director to have an assigned response vehicle that enables him or her to respond from wherever he or she may be to mass casualty incidents or unusual occurrences, or to focus attention on particular incidents that are a priority in the QA/QI process. Medical directors who have assigned response vehicles should meet the same training and performance requirements as other members of the service who drive emergency vehicles. The vehicles must be appropriately equipped for emergency response and have communications equipment and medical supplies, including a defibrillator, and should ideally undergo the same state inspections and credentialing as other EMS vehicles. The medical director must have appropriate personal protective equipment (PPE). The specifics of any region’s EMS system will determine the role of the medical director in protocol development. Some systems function under state-wide protocols, and others use regional or local protocols. Regardless, medical directors must be leaders in protocol development and continuous review. The evolution of EMS as a medical subspecialty parallels the growing evidence base for the practice of prehospital medicine that has been published over the past several decades. Historically, EMS protocols were extrapolated from in-hospital practice. Today, they are more often developed using scientific literature derived from prehospital studies, with input from EMS physicians and prehospital professionals. Medical directors must ensure that protocols are relevant and appropriate for the local system by taking available resources and community needs into consideration. In developing protocols, the medical director needs to be familiar with the existing scientific literature and the evolving evidence-based guidelines and model protocols that are available today. Although protocols reflect the needs of any given EMS system, basic principles of treatment and transport destination should embrace the best available evidence. Protocol development is anything but a static process and medical directors must commit to regularly scheduled audits of prehospital practice and modify treatment protocols as appropriate. Finally, emergency medical dispatch protocols affect the first interaction between an EMS system and the citizens it serves. Physicians should be engaged in the implementation and quality review of dispatch protocols [35]. While prehospital protocols have historically varied from system to system, there is a growing trend toward more standardization. Since 2008 the National Highway Traffic Administration and the EMS for Children Program have collaborated with a working group composed of prehospital providers, physicians, and administrators [36]. The working group used the GRADE process to review current evidence with respect to field pain management and the air medical evacuation of trauma patients. It is anticipated that this project will form the foundation for a process to develop evidence-based guidelines in the future.
Medical oversight of EMS systems
Introduction
The evolution of the subspecialty of EMS
State requirements for EMS medical direction
Barriers to effective medical direction of EMS
Indirect medical oversight
EMS provider education
Verification of competency and EMS provider credentialing
System quality assurance and performance improvement
Field clinical supervision
Protocol development
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