SECTION 2: Medical Oversight

INTRODUCTION

EMS in the United States is a hierarchical care delivery system, with physician leaders working in partnership with EMT/paramedic providers to rescue, care for, and transport patients. Alternative system structures are possible, and work well in other countries and settings. These include both systems with more physician involvement (physicians routinely staffing ambulances), and systems where EMS providers organize and manage their system with little or no physician input. The US model includes a robust prehospital emergency care network in which care is directly provided by predominantly nonphysician prehospital providers. The physician role in this type of system is heavily weighted toward oversight and direction of the system and through direct contact with providers in the field when called for medical control. This chapter will provide an overview of these topics and following chapters will provide greater detail on each of the elements discussed.

OBJECTIVES

1. Define the terms medical control, medical direction, and medical oversight.

2. Describe online (telecommunications and in person) and off-line medical direction.

3. Discuss qualifications for providing medical direction.

4. Describe proper base-station training for EM and EMS physicians.

5. List the components of medical oversight.

PHYSICIAN ROLES IN THE EMS SYSTEM

Although not explicitly stated in some of the original governmental documents describing the EMS system in the United States, medical direction and physician oversight have always been key components to the development and operation of prehospital emergency care services. Although it has been surmised that physician involvement was always assumed, later documents specifically call for medical oversight. This function has evolved over time and can be described in terms of four general types of physician involvement.

ONLINE MEDICAL CONTROL

Online medical control, also known as direct medical control, refers to consultation between EMS providers and a physician, typically by radio or telephone, to guide care for an individual patient or EMS incident. These physicians are usually required to take a base-station course and maintain up-to-date knowledge of the EMS treatment protocols. The majority of the physicians providing this type of medical control are not EMS physicians or EMS agency medical directors. Typically, they are the emergency physicians on duty in receiving emergency departments (Figure 4-1). However, in some cases they may also be assigned this duty exclusively when working a medical control shift in a larger system. Another form of online medical control is on-scene medical control. This refers to the presence of the physician at the patient's side during EMS care, working directly with EMS providers to deliver care (Figure 4-2). These physicians may be referred to as EMS physicians or flight physicians. When the on-scene EMS physician is also the medical director, this allows for four components: (1) provision of orders and direction of care, (2) evaluation of provider performance, (3) provision of postincident education, and (4) evaluation of system design and operational parameters. Physicians responding to the field should have proper training, awareness, and equipment. Minimum requirements include operational proficiency in operation of an emergency vehicle, radio communications, scene size-up and safety, proper attire and personal protective equipment, use of EMS equipment, and regional procedures for utilization of prehospital resources and response plan(s) for mass casualty incidents and disasters.

OFF-LINE MEDICAL CONTROL

Off-line medical control, also known as indirect medical control, typically refers to physician duties performed at an ambulance service or local level. The physician reviews care reports and other data to provide feedback on care delivered to improve quality and other aspects of care. The medical director will oversee continuous quality improvement (CQI) programs, primary and continuing education programs, verification of skills and competencies, criteria for determining overall fitness for duty, and the controlled substance handling and antidiversion program. Off-line medical control also includes development of medical care policies, protocols, and procedures. This type of medical control also includes the authorization of licensed prehospital providers to participate in care as a member of an agency or system. It may also include the authorization of ambulances and other response vehicle for use in patient care and to care medical equipment and medications.

MEDICAL DIRECTION

Medical direction is sometimes considered the same as off-line medical control. Although it does include this activity, it is a higher level of involvement at the agency level. This refers to advising agency administrators on minimum standards for providers, setting educational standards, reviewing policies and procedures, and advising on medication and equipment choices. Despite some administrative functions, the medical director is not the EMS system administrator in the vast majority of cases. Administrative directors (CEO, COO, director of operations, etc), as opposed to medical directors, typically focus on finance, human resources, staffing, contracts, political relations, and protection of corporate interest.

MEDICAL OVERSIGHT

Medical oversight is typically performed by a medical director(s) at the local, regional, and state levels, in collaboration with regulatory authorities, regional/county medical directors, and advisory committees in many jurisdictions.¹ In addition to the duties described under off-line medical control and medical direction, medical oversight involves interaction with local, regional, and state authorities and stakeholders. Medical oversight requires a broad understanding of the emergency medical system as a whole and ensuring proper policies and procedures exist to ensure safe transitions of care and the utilization of appropriate resources in the field.

MEDICAL CONTROL, DIRECTION, AND OVERSIGHT

The four EMS physician roles (online medical control, off-line medical control, medical direction, and system oversight) may overlap, have multiple and ambiguous titles, or receive variable focus depending on individual system parameters, but they should be understandable as a progression from direct patient care through consultation regarding that care, review of care, and system design/oversight to optimize care.

Medical control, both on-scene (EMS physician) and online (direct), implies a concurrent process with patient care. In other words, the physician input occurs during the care of a specific patient or patients (in a multiple casualty incident where simultaneous consultation occurs regarding a group of patients). The on-scene EMS physician may be an integral part of the ambulance or helicopter crew, serve in a responding supervisory role for a region or system, be a service medical director who supports the service through scene presence, or may be a member of a major incident, search and rescue, or disaster response team. These physicians should be integrated and accepted members of the EMS scene presence, and their role (which may vary significantly) should be clearly understood by the EMS providers, the EMS physician, local emergency departments/hospitals, and the system oversight authority. Otherwise, conflict may occur between the on-scene EMS physician and the system's physician substituted judgment as reflected in guidelines and protocols. Online (direct) medical control also occurs concurrent with patient care, typically during a telephone, radio, or computer communication between EMS providers and an emergency physician at the intended receiving hospital, “resource” hospital, or designated medical control base station (or telemetry station). The online medical control physician must be rapidly available, have sufficient understanding of the communications technology employed and the EMS system to interact in a helpful manner, and be able to promptly provide concise guidance to EMS providers based on current protocols and available drugs and equipment.

Medical direction typically includes both off-line (indirect) medical control and other functions of a service or system medical director, such as training, quality assurance, pharmaceutical, and other responsibilities. However, in many jurisdictions, off-line medical control is provided by a physician or committee at a designated hospital or governmental entity. In these situations, quality assurance review of EMS charts is augmented by (HIPAA-appropriate) access to emergency department and hospital records. Ideally, the service medical director collaborates with the off-line medical control process to institute quality improvements when the two functions are performed by different people or institutions.

EMS system oversight is a collaborative process that includes physician consultation with a regulatory/licensing authority (often at the state department of health, public safety, or department of transportation) and cooperation with various committees and boards comprised of physicians, EMS providers, and other stakeholders (hospital staff, specialty clinicians, representatives of various interest groups, etc). Physicians involved in system oversight must have an understanding of public health, financial and political influences on the system, human resources issues, and other administrative aspects of EMS. In some states, a physician medical director holds strong authority over system design, scope of practice, and other aspects of EMS practice. In other cases, the state-level authority functions in an empowering and coordinating role, and most aspects of EMS practice are controlled at a regional, county, or even individual service level.

PHYSICIAN KNOWLEDGE AND INVOLVEMENT IN EMS

In order to prevent substandard medical control, direction, and oversight, systems should require formal standardized training for physicians providing these important functions.

ONLINE MEDICAL CONTROL

The most basic qualifications for physician involvement in EMS apply to online medical control physicians. These physicians are in communication with EMS providers during patient care. Therefore, they must understand the local EMS system, including provider levels and scope of practice, use of guidelines and/or protocols, and communications technology. There may be additional knowledge required depending on the use of special EMS resources (tactical teams, urban search and rescue teams, wildfire or wilderness EMS providers, mass or sports event EMS, etc) in the area. In almost all cases, they should be emergency physicians or pediatric emergency physicians as indicated by patient age. Prompt availability for consultation implies either presence in an emergency department or a system where the online medical control physician is designated to provide this service and equipped with the necessary communications tools. Training for these physicians, assuming that they are residency trained in emergency medicine and have immediate access to relevant documents (guidelines, protocols, patient destination plans, etc) can be brief, likely fewer than 5 hours, and may be significantly amenable to online or other distance learning techniques. While many of these topics are covered in the emergency medicine residency curriculum, local system variation mandates additional training/orientation. After confirming initial competence, recurrent training and verification are necessary when there are system changes (protocol updates, new treatments, changes in destination plans, etc). Specific topics that should be covered in training include a number of important introductory concepts (Table 4-1).

ON-SCENE MEDICAL CONTROL

More extensive training is necessary for physicians who provide on-scene medical control. In addition to the knowledge necessary to provide online medical control, physicians who respond to the scene must be familiar with EMS equipment and practices, scene safety, local incident management hierarchy, and system-specific practices related to physicians at EMS scenes. If driving emergency vehicles or responding to incident scenes, these physicians should have experience or training in emergency driving techniques, safe scene parking practices, and use of warning lights and sirens. To effectively integrate into the EMS system, these physicians should be familiar with, and be accepted by, the leadership and EMS providers they work with, and with staff at local emergency departments. Training requirements for these physicians will vary depending on their background and system parameters. Those who worked as EMS providers prior to becoming physicians may require shorter training and should achieve competency more rapidly. Systems where the physician is more hands-on with extrication, rescue and other technical aspects of EMS will need more training time, whereas systems using on-scene medical control in a more hands-off advisory role may achieve competence (including training the physician regarding safety around technical EMS efforts) in a shorter period of time. Systems where the physician provides transport care (by ground ambulance, helicopter, or other vehicle) will need to include training for those aspects of care, perhaps including vehicle operations, inventory, altitude physiology, etc.² Topics that should be covered in training in addition to those for online medical control are listed in Table 4-2.

OFF-LINE MEDICAL CONTROL

Physicians providing off-line medical control should have a thorough understanding of the EMS system beyond that required for online medical control, and a basic understanding of the system's use of on-scene medical control, if any. In addition, these physicians should be comfortable with topics such as CQI, risk management, HIPAA requirements, liability protection, and understand their responsibilities and authorities as system managers (Table 4-3).

A key component of the provision of off-line medical control is the review of documentation. For the physician to be effective in this role, they must possess a detailed understanding of the mechanics of charting (Which EMTs complete the record? Is it electronic, paper, or both? Do all members of the care team sign the record? What about EMTs who did not accompany the patient during transport? What path does the record follow through the QA process and beyond?). Maintaining regulatory compliance and ensuring high-quality care require the physician to understand the role of quality assurance/improvement systems in improving care, reducing risk, identifying both excellence and concerns in care variations, aggregating data, protecting data, and transmitting results of review to providers, services, regulators, and others.

Processes vary from agency to agency and the medical director must know the mechanics of review for their agency (Does the review occur by computer, on paper, or both? Is there a committee or an individual reviewer involved? How are the results recorded? Are they peer protected, and what is the mechanism for ensuring this protection throughout the process? How are the review results transmitted to providers and others? Supervised practice reviews are recommended). In order to protect themselves, the providers, patients, and the agency from unnecessary distraction from the prehospital care mission, the medical director must be aware of certain legal issues (How is liability protection provided for the reviewer? How is due process protected for the EMS provider? How is patient confidentiality protected during the review process? Are meetings or hearings open, or closed? May services or providers present evidence, witnesses, or be represented by union officials or legal counsel at such meetings? How is peer review protection (if claimed) protected throughout the process?).

AGENCY MEDICAL DIRECTORS

Agency medical directors responsible for local or regional EMS systems will need additional training depending on their role. They should have a good understanding of the medical control topics discussed above, particularly if they serve in those roles for their service(s). Medical directors develop, review, and revise medical policies, protocols, and procedures. They authorize levels of practice of providers. They establish policies relative to difficult medicolegal issues such as refusal of care/transport, end-of-life issues, and termination of resuscitation. Medical directors must be up-to-date with pertinent medical literature and research interpretation and design. While systems vary, ideally the service medical director should have final authority over all aspects of the service that involve health and medical care, and be responsible for all relevant aspects of the service. In some situations, medical directors have limited arrangements with ambulance services, and therefore additional topics that may be relevant include:

• EMS provider safety: EMS is a dangerous profession, with a significant risk of injury from vehicle operations, infection or injury from patient care interaction, psychological stress, physical stress during operations, and fitness issues. The service medical director should be aware of these issues, be involved in service decisions that affect EMS provider safety, and be an advocate for safety within the EMS system.

• Guidelines and/or protocols: some service medical directors practice in systems where they author individual service guidelines or protocols, and the EMS providers practice under the physician's license by following these guidelines/protocols. In these systems, understanding the authority and authorship of guidelines/protocols is important.

• Human resources: Essential if the medical director is involved in interviewing, hire/fire/discipline decisions, setting workplace parameters and accommodations for employees, etc. In most cases, it is more appropriate for the medical director to understand, but not to participate in this component. Rather, they should strictly restrict their activities to authorization to practice and fitness for duty.

• Billing and reimbursement: Important if the medical director is involved in verification of billing levels, attests to levels of care required, helps decide destination facilities, vehicle or crew choices, or treatment options that influence billing, etc.

• System integration: How does the service obtain mutual aid, assist with disaster operations, fit into regional plans for care, interact with regulatory authorities, etc?

• Vehicle and equipment options: How does the service choose and maintain vehicles and equipment? Do they provide for safe EMS operations and meet the standard of care for patient treatment? Is provider training sufficient to provide safe and optimal care? The physician medical director, as final arbiter of all aspects of the service affecting patient care and the health and safety of employees, must be involved in these decisions and may be held responsible for the service's choices.

• Service management: Does the service's management structure, scheduling, reimbursement, benefit package, and other aspects of business operations respect EMS providers as professionals with their own health and safety needs? If the service is staffed by volunteers, how are they provided with equipment, a safe schedule, adequate training, personal protective equipment, etc?

Different agency types and structures can incorporate their medical director in various ways. Knowing the organizational chart for the agency receiving medical direction will help the physician understand their role and chain of command in the eyes of the agency leadership (Figure 4-3).³

MEDICAL OVERSIGHT

In order to provide medical oversight as a regional, county, or state medical director, the emergency physician should be generally knowledgeable about the above topics and have a detailed and specific knowledge of a number of relevant areas. Understanding the interplay between public health and EMS and how the state EMS system integrates into general public health efforts is key. Being able to evaluate the metrics that justify (or could help support improvement in) the state's EMS system and knowing how the state is working to advance EMS, for providers, services, and patients, can guide physician efforts and program initiative development. Taking part in the state addressing challenges facing EMS, such as financial constraints, EMS provider workforce issues, patient obesity, infection risks, major incident/terrorism threats, integration of air and ground EMS services, matching available level of care to patient need, and other basic controversies can lead to greater integration and help focus efforts on patient outcome across the system.

Mastery of the state-specific EMS system structure leads the physician to answers to important questions—How are licensing, regulation, discipline, quality assurance, scope of practice, and other issues decided and managed at the state level? What committees and boards are involved? What is the authority and expectation of each? What are the state's special interests or challenges (geography, climate, disease prevalence, etc)? What laws and regulations control EMS in the state, and do they need modification? Without specific operational knowledge of these components, it is impossible to actively develop relationships and programs aimed at process improvement and increase in health care quality and value.

Knowing the occupational and legal expectations and protections afforded to a physician providing system medical oversight is essential in order to avoid experiencing incapacitating shortfalls and surprises. The physician must understand what liability protection is extended and how much time is needed to perform the job properly. Key occupational components such as required travel, compensation, and employment (or contractor) status are essential parts of any medical oversight agreement. Ultimately the physician must also know what the physician's authority is within the system, who they may answer to (politically or otherwise), and how conflicts of interest are managed.

Finally, there must be recognition of the way in which the system is meant to integrate into the larger EMS System. Important questions need to be asked in every system—How does the system obtain mutual aid from neighboring states? How does it handle response across borders? Does the state follow national standards for training, patient care, EMS provider safety, and physician involvement? Are the state's EMS physicians active in relevant organizations at a state and national level? How are the state's EMS physicians participating in EMS research and education to advance the field?

PERSPECTIVES ON EMS PHYSICIAN ROLES

The above discussion assumes a patient-centered role for the physician involved in an EMS system. However, there are other ways that physician involvement in EMS can be organized. For example:

• Patient care: Primarily as described above, but most of the focus above is on “9-1-1 emergencies,” and not on critical care transport, or transport of special needs patients, for example.

• EMS research: Some physicians participate in the EMS system primarily or solely through their research efforts to improve EMS care.

• Product development – some physicians are involved in EMS product development, pharmaceutical applications in EMS, etc.

• Special response/incident teams (mass events/sports, HAZMAT, tactical, wilderness, marine, dive rescue, search, cave rescue, disaster, urban/structure, fire (particularly wildland fires), ski patrol: All of these response types present special challenges and opportunities for the interested physician, and require specific training.

• Training and education: Physician educators can integrate with the EMS system through various educational efforts, including injury prevention efforts provided for the public, EMS provider training, and training of EMS physicians. Use of distance learning, adult learning techniques, just-in-time training, high-fidelity simulation, and other techniques make this an exciting and challenging aspect of EMS, particularly since manual skill is just as important as book knowledge. With the advent of EMS as a recognized subspecialty of emergency medicine, physicians will be more involved in EMS as both teachers and learners.

• Documentation and billing: Physicians have developed billing companies, software to document care, integrated EMS dispatch/tracking/documentation/billing suites, and other technologies to assist with EMS documentation, quality assurance, and reimbursement.

• Policy: EMS is an evolving field, and therefore subject to policy scrutiny. Recent efforts by NHTSA to develop research and education (provider levels and scope of practice) agendas⁴ are evidence that physician input is essential in this area.

• Organizations/associations: Many physicians are active in EMS at a national or international organization level, usually as an adjunct to other EMS activities. The National Association of EMS Physicians (NAEMSP), the Air Medical Physician Association (AMPA), and the National Association of EMS Officials (NASEMSO) are three major EMS-focused associations. There are also active EMS sections within ACEP, SAEM, and other physician organizations.

REGULATION OF EMS PHYSICIANS

Individual ambulance services may, through job description, contract, or typical practice, impose limits and expectations on EMS physicians they interact with—typically with a service medical director, but also with hospital-based providers of online (direct) medical control and other physicians. Local, regional, or state EMS authorities may similarly have expectations for the EMS physicians practicing in (or visiting) their area, including those providing on-scene care, medical direction, and system oversight. This regulation may take the form of minimum qualifications, required training, certification, contractual requirements, authorization to participate in the system, limits on authority, etc. Similarly, EMS physicians should have expectations of the EMS system, services, and providers they interact with. This may include reassurance regarding liability protection, access to technology, compensation, authority to direct care and other practices in accordance with standards of care and their wishes, input into budget, equipment, and personnel decisions, and other important areas of practice.

Some states have formalized EMS physician interaction with their system at a statewide, regional, or service level. This involvement can be centralized, or distributed among regions, counties, or even individual ambulance services. For example, in Maine EMS authority is centralized by a law which requires appointment of a state EMS medical director and regional medical directors. Together with a representative from the Maine Chapter of the American College of Emergency Physicians, these EMS physicians develop statewide EMS protocols and perform other duties.⁵ Maryland has a more distributed system, with the physician authority empowered by regulation, including state, regional, and local “operational program” (service level) medical directors all regulated by a board of stakeholders appointed by the governor.⁶ In Massachusetts and Rhode Island, the actual authority is held by the state EMS office, and the physician EMS medical director and various boards and councils have advisory input.^7,8 In Ohio, a more distributed system, a state board with physician input sets maximum limits on scope of practice, but individual service physician medical directors control the actual practice protocols for each service.⁹

Various professional organizations provide guidance on EMS physician practice, and offer education, position statements, research forums, and other support. To a large extent, these efforts provide a forum for and repository of EMS physician practice and training guidelines in the United States. Several offer position papers on training and qualifications of EMS physicians in various roles, and provide training for physicians seeking to meet those qualifications.

NAEMSP

The National Association of EMS Physicians, founded in 1984, is a US association focused entirely on EMS physician practice. It publishes a journal, hosts conferences, publishes texts, and coordinates efforts such as a Council of EMS Fellowship Directors and a curriculum for EMS fellowships (www.naemsp.org).

AMPA

The Air Medical Physician Association, founded in 1992, is a US-based international association focused on physician involvement in ground and air critical care transport aspects of EMS. It publishes a textbook, collaborates in publication of a journal and organization of several annual conferences, has position papers, and supports EMS research (www.ampa.org).

SAEM

The Society for Academic Emergency Medicine also has an EMS interest group and offers an EMS fellowship scholarship (www.saem.org).

ACEP

The American College of Emergency Physicians has a standing EMS committee and interest sections including EMS and Air Medical Transport (www.acep.org).

Both ACEP and NAEMSP have provocative position statements concerning the medical direction of EMS services and are relevant to EMS physician studies. The ACEP position statement covers components and medical director qualifications for off-line medical control, online medical control, local EMS medical directors, regional/state medical directors, and medical directors for air medical, nonemergency, wilderness EMS, tactical EMS, interfacility transport programs. The ACEP site reviews the ideal qualifications, responsibilities, and authority for each type of medical direction and discusses how the system should support these activities.¹⁰

EMS PHYSICIAN TRAINING

Many physicians involved in EMS are former, or current, EMS providers, having begun their medical careers as EMTs or other first responders. Emergency medicine residency training, according to the ACGME Residency Review Committee, must include “Residents must have experience in emergency medical services (EMS), emergency preparedness, and disaster management.

1. EMS experiences must include ground unit runs and should include direct medical command.

2. This should include participation in multi-casualty incident drills.

3. If programs require residents to ride in air ambulance units, the residents must be notified of this requirement and associated liabilities during the resident recruitment process.

Residents should have experience teaching out-of-hospital Emergency Medicine emergency personnel.¹¹ While no specific time parameters are included in these requirements, many residencies fulfill them in the equivalent of 2- or 4-week rotations during 3 or 4 years of residency training. For those emergency physicians seeking deeper understanding of EMS, and a career focused on EMS, fellowship training is available. On September 23, 2010, the American Board of Medical Specialties unanimously voted to make EMS a medical subspecialty, under the auspices of the American Board of Emergency Medicine (ABEM),¹² but exact training and certification requirements were not clear until the ACGME accreditation process began in 2013. The advent of this subspecialty certification begins a process where EMS fellowship training, and subspecialty certification are likely to become highly recommended or required for physicians focusing their career on EMS. More detail on this area is contained in Chapter 3.

KEY POINTS

• The American Board of Medical Specialties (ABMS) approved EMS as a subspecialty under the American Board of Emergency Medicine (ABEM) on September 23, 2010.

• There are four major roles for physician involvement in EMS: on-scene medical control, online medical control, off-line medical control, and EMS system oversight.

• Other physician roles also include research, education, product development, disaster response, mass event/sports coverage, and integration of EMS with the rest of the health care system.

• All physician EMS roles require training, integration with the EMS system, and continuous efforts to improve quality, safety, and patient care.

REFERENCES

INTRODUCTION

Prehospital emergency medical care by EMS providers can be defined as physician-directed medical care in the prehospital setting with or without ambulance transport. A wealth of details clarifies this definition within specific jurisdictions and for particular circumstances. The care provided by prehospital providers as a part of the EMS system is a practice of medicine with standards of care established by the training and experience of practitioners and system leaders. Therefore, a key component of the EMS system is physician oversight and medical direction. A well-developed and well-designed EMS system usually incorporates four opportunities for physician input:

• System design

• Operational policies and guidelines

• Patient care protocols

• Medical direction

In an excellent EMS system, all four opportunities are coordinated by EMS physicians collaborating with EMS professionals to produce excellent and efficient care for patients while improving all aspects of the system and the providers working within it. System design, at a national and state level, provides guidance regarding curriculum, scope of practice, regulatory & licensing structure, and other overall aspects of the EMS system. Medical direction, provided at the time of care (online) and all other activities of the medical director (off-line), is discussed in Chapter 4. This chapter focuses on the development of protocols, policies, procedures, and guidelines and defining important concepts relative to these activities.

OBJECTIVES

• Define the terms guidelines, policies, procedures, protocols.

• Define the terms scope of practice and standard of care.

• Discuss how the above concepts relate to the medical care provided in the field.

• Describe the processes involved in development of guidelines, policies, procedures, and protocols.

In order to fully appreciate the importance of clear and definitive documents defining prehospital medical operations, it is essential to know the purpose of the different document types and understand how they serve to define the parameters by which prehospital care is delivered. If the medical director confuses these components, and their purpose, there is potential for inappropriate development of these documents that could lead to operational, regulatory, legal, and medical complications.

KEY TERMS AND DEFINITIONS

Guidelines: provide broad parameters for management of a particular problem. They should be the result of expert consensus, based on evidence, and typically apply at a national or international level. An example would be recommending early 12-lead ECG acquisition for EMS patients with possible cardiac ischemia as a method to triage STEMI patients to the best treatment option.

Scope of practice: is the range of care expected and allowed for a particular type of care provider, such as an EMT or paramedic, but the term applies to all types of providers. It typically is described in laws, regulations, and protocols and includes allowed procedures, medications, and requirements for each type of provider in a system. Scope-of-practice documents define the bounds of practice expectation and procedural limits for providers. An example would be describing the level of provider and training required to acquire and interpret a 12-lead ECG. In many cases performing and intervention outside a provider's scope of practice could have legal implications, even if they were given an order by a physician to performing an intervention.

Standard of care: is the minimum acceptable quality of practice expected of a provider of similar level or type facing a particular situation. The standard of care for any particular instance is usually derived from review of medical literature, position papers from expert panels, and by examining local practices. It is typically limited by the scope of practice and defined during legal proceedings through review of these materials and the expert opinion of providers with the same or similar training as the provider being evaluated, and should be applied to the same or similar clinical circumstances. Acceptable practice is performed above the standard of care; practice below the standard of care is negligent practice. While some aspects of the standard-of-care apply without regard to geography, variability in EMS scope of practice, guidelines and protocols may create local and regional variations in the standard of care. An example would be the expectation that trained and equipped providers would obtain a 12-lead ECG early in the care of a 48-year-old patient with acute onset of atraumatic chest pain. Breaches in the standard of care can be ground for the allegations of malpractice in cases where harm and causality can be established.

Policies: set forth the general operational parameters for a system or service. They encompass all aspects of operation (eg, human resources, equipment maintenance, and response for patient care, etc). They may reflect these elements of a national organization, a state agency, or an individual ambulance agency. Examples would be the ACEP Policy on Leadership in Emergency Medical Services,¹ or an ambulance agency policy that sets out a clinical goal to provide the best possible patient care.

Protocols: specify care, often including the chronological order of care, for a specific situation or patient complaint. They are often service or system specific. They implement guidelines and policies. An example would be a protocol that sets forth the steps expected by the EMS system in the care of a 48-year-old patient with chest pain.

Procedures: are delineated methods to perform tasks or implement policies and protocols. They are typically detailed, ordered, and specific to the service, piece of equipment, or task. An example would be the exact steps necessary to acquire a 12-lead ECG using the particular brand and model of monitor available at a particular ambulance service.

OTHER DEFINITIONS

Physician directed: means that properly committed, knowledgeable, and collaborative physicians provide oversight for the EMS system. EMS is a developing subspecialty, and board-certified EMS physicians will eventually become the logical choice to serve in this role, supported by consultation with other medical specialties as indicated. Currently, many physicians with varied training and backgrounds provide EMS system oversight. This physician oversight may take many forms, and does not require that a physician be present at every EMS incident, communicate with EMS providers during every patient transport, review every document, or teach every EMS course, although these circumstances may be indicated at times. Instead, what we mean is that physician oversight is reflected throughout the EMS system wherever patient care is involved. This oversight may, for example, take the form of EMS provider scope of practice and curriculum guidance, direct and indirect education, research, efforts to seek and secure system funding, provider standards and supervision, development and interpretation of guidelines, policies, protocols and procedures, and other measures that implement physician judgment throughout the EMS system. The degree and mechanism of physician direction will vary from system to system, as designated by the laws, regulations, and other guidance of the jurisdiction.

Ambulance: refers to any vehicle or conveyance used to transport patients or personnel and equipment used to treat patients, including all associated equipment, supplies, and medications. These vehicles may or may not be dedicated to sole use as ambulances, may or may not be motorized, and may be designed for a variety of travel environments (ie, air, on and off road, water, snow, mud, wilderness, urban structures, etc). Ambulances and their associated equipment may be specified by, inspected by, and their operation and use controlled by the EMS system. The degree and mechanism of ambulance control and regulation will vary from system to system, as designated by the laws, regulations, and other guidance of the jurisdiction.

Transport: means the potential that a patient or patients may be best served by physical relocation from their current location to another for medical care, safety, or other associated purpose. This may include evaluation and care to determine if such transport is indicated, the actual movement of patients within or between entities or facilities, and any associated vehicles, mechanisms, and personnel. It also includes search for and rescue of patients from entrapment or other hazardous circumstances, evacuation of persons during a time of hazard, care at gatherings and mass events, and transportation to, from, or between temporary, emergency, or alternate health care entities.

Patient: any person to whom the EMS system owes, or may owe, a duty of care. Patients may include those who have gathered at a mass event and are potentially in need of medical care, persons living in or located in a particular area or circumstance (such as a flood zone or epidemic area), persons in routine or emergency need of medical evaluation, care, and/or transportation, and any other person within the jurisdiction of the EMS system who may be affected by the design, operation, regulation, or other aspects of the EMS system and its personnel and equipment.

Care: is that medical evaluation and treatment provided to a patient by an EMS provider. It may include physical relocation to a place of greater safety, remote evaluation of patient circumstances or risk, efforts to identify a patient, obtaining a medical history from the patient or others, hands-on physical examination, testing (including laboratory testing, imaging, and other evaluation), and treatment with medications, devices, equipment, and transport. Care includes ensuring the safety of patients, providers, and others through the use of accepted means to immobilize, restrain, protect, splint, isolate, and otherwise provide measures that protect patients, providers, and others from harm.

GUIDELINES, POLICIES, PROCEDURES, AND PROTOCOLS AS TOOLS FOR DEFINING EMS SYSTEM STRUCTURE

Organization of EMS systems is, ideally, logical and transparent. When asked, “Why do we do it that way?” it is helpful to have both evidence and structure supporting the answer. Proper development of (or reference to) relevant guidelines when defining scope of practice, creating protocols, and drafting policies and procedures provides the foundation for good quality EMS practice. The tools then available to system leaders (protocols, procedures, etc) are used to ensure that best practices are provided throughout the system. Of course, a thorough quality improvement system is necessary to close the loop.

GUIDELINES

Guidelines paint, in broad strokes, current best practice information (or the lack thereof—such as the lack of a single recommended outcome measure for cardiac arrest studies²). They are a means to promulgate current best practice information throughout the EMS system. They should be developed using an objective, transparent, and commonly accepted approach to evaluating the evidence, and should answer important clinical questions. However, guidelines require interpretation and review before application during patient care.

The development of guidelines probably does not occur at a local level. As a statement of expert consensus after review of the best available evidence, guidelines are typically beyond the scope of a local EMS system. However, to be applied locally they need to be examined and interpreted to ensure that their local use matches needs, operational capabilities, and realities, and can be measured through a quality assurance process to assess both positive and negative influences on the local EMS system. A number of national professional organizations maintain guidelines (sometimes referred to as positions) relevant to EMS systems (eg, National Association of EMS Physicians, American College of Emergency Physicians, American Heart Association, American College of Surgeons). A process should be described for the evaluation of the evidence used in development of these guidelines, including scoring of the evidence considered³ and conflict of interest management during involvement of the experts involved in the guideline development process.⁴

POLICIES

Policies generally flow from the overall system mission and operational goals. They should have a standard format that transparently identifies the author or authors, the authority for the policy, date of origination and any revisions, and a system to catalog revisions as they occur. Policies reflect the personality of the agency and set out goals for operations and practices, but do not provide details about how those goals are carried out. Flowing from administration and vetted through an established process, policies must also be checked to be certain they comply with applicable laws, regulations, and accreditation standards. If review by state or regional regulatory organizations (or officials) is necessary, an inherent delay must be anticipated in the implementation of these policies. Policies should be clear, concise, and as brief as possible.

PROCEDURES

Procedures are used to itemize the exact process by which policies and protocols are implemented. Procedures are very specific to a particular brand of equipment, for example, or to local circumstances. While a policy may call for adherence to state protocols for management of patients with various emergencies, a procedure will tell the EMS provider how to operate the patient monitoring equipment, where the medications are kept in the ambulance, and how to complete the agency's documentation.

PROTOCOLS

Protocols specify patient care. By the nature of being a protocol, they imply a protocol-based approach to medical care. Typically this means giving specific directions to be used in response to identified problems, symptoms, findings, and situations. This may vary in implementation from a loose structure to a strict algorithm. Box 5-1 illustrates the function of the above types of documents in an EMS system.

PROTOCOL DEVELOPMENT

Medical director input on the development of policies and procedures is important to the overall ability of the EMS physician to provide oversight to areas pertaining to medical operations (eg, controlled substances, dispatching, infection control, etc); however, protocol development is arguably the most important off-line component of medical direction. The protocol by which prehospital care is provided is an extremely important document around which the majority of the medical directors' other off-line duties revolve (ie, CQI and education).

DESIGN TEAM

The medical director should consider the system for which the protocol is intended and seek to involve key members of the system in the design process. A protocol being designed for a single agency in a defined geographic location may need a team of stakeholders that simply includes the medical director and several senior prehospital providers or supervisors who can help fact check and provide feedback on the usability and applicability of the protocol. These individuals will also provide the medical director with essential information about the perception and interpretation of the language and flow of the document. At times, these individuals may also note errors in design relative to scope of practice issues and help point out areas of significant educational deficits that will need to be addressed at the time of protocol rollout education. In cases of larger systems (ie, regional or state), there may be multiple medical directors and specialty physicians involved in development. Stakeholders from various type of agencies (ie, fire based, commercial, municipal third service, volunteer) from various geographical areas (ie, urban, suburban, rural, super rural) should be consulted and/or actively involved in the development of the protocols to ensure that the document represents a deliverable level of care that serves the needs of the agencies and patients it is designed to serve.

DESIGN STRUCTURE

Protocol design includes decisions about how to reflect the system's structure, goals, capabilities and limitations, and philosophy. Graphic layout and structure is an important feature of design. The quality of the flow and usability of the protocol by all levels of provider is an important area of focus and a number of questions should be asked (Box 5-2).

Specific physical features of the protocols may be, in part, determined by the size and environment in which they are used. Most systems favor a protocol book than can be carried in a pocket in some format. This allows the provider to efficiently reference the protocol in times of question or if there is a need for clarification. This limits the content and design somewhat in that a lengthy and verbose text would not logically provide for this requirement. Due to the desire to have a convenient reference for providers, many protocols have taken on a somewhat graphic appearance. In some cases this means they are color coded or in the form of a flow diagram. This may allow conveyance of more information with less text. If the steps of the protocol are to be followed exactly in order, they may actually be numbered or represented in a vertical fashion (Figure 5-2) instead of being designed as a branching algorithm (Figure 5-3) or flow chart. The depth of the information presented in the protocol can vary and some have a large amount of reference detail added to each page in order to provide some educational component and allow providers to “study” the protocol and look up referenced material during downtime. Other reference material, such as guidelines, standards, call centers, and online databases may also be included in protocols that are designed in this fashion. Another approach is to streamline the protocol to show only the core steps in care and to provide separate reference documents and protocol education. The advantages of this style might be size and easy of reading.

IMPACT OF INTENDED IMPLEMENTATION ON DESIGN

Although the definition of a protocol is fairly specific, there is a significant amount of variability in the way in which they are employed in the provision of care by prehospital providers. Based on variability in scope of practice, regulatory limitations, and local standards of care, the medical director may need to adjust the protocol design to fit with the needs of the system. In some cases, protocols may appear almost like guidelines with open-ended points that seem to represent recommendations and reminders, whereas others may be so detailed and ordinal that they appear to represent an algorithmic recipe with little to no room for interpretation or judgment. The protocol development team must consider this variability and choose a style and structure that best suits the needs of the system. When considering a protocol they should ask a number of questions (Box 5-3).

Approach to Protocol Application

Clinical features of a particular patient encounter can change during the prehospital phase of care. This is true in time of discovery of new information when caring for a patient who is found to be a poor historian, during reevaluation, or in response to therapy. These changes in clinical state and presentation may change the prehospital treatment goals for the patient at that time. If the intent of the protocol is that the prehospital provider will choose a protocol and “stick” to it through the rest of the care, it may be necessary to ensure that more extensive, and at times redundant, steps are contained in every one of the protocols. Alternatively, if the provider is allowed to move from protocol to protocol in response to new and changing clinical information each one could be more concise and potentially contain prompts referencing other protocols.

Protocols also typically contain prompts that usually include criteria for contacting online medical control. Typically this is when unusual circumstances are encountered, notification is needed in order to activate specialty services at the receiving facility (eg, trauma team, catheterization lab, stroke team) or in the field (eg, helicopter, EMS physician field response), when local regulatory or scope-of-practice constraints are met, or when a perceived high-risk action is to be taken (eg, termination of resuscitation, high-risk refusal). The basis for the need to contact online medical control must be based on the specific needs of the particular system. In some systems, this may be required for the administration of controlled substances and the signing off of a patient refusal, whereas other systems may require almost no online medical control unless the provider deems it necessary or when a deviation from protocol is requested.

Provider Discretion

In some systems, protocols are designed to provide the prehospital provider with options to allow for clinical judgment and provider discretion. The protocols are written in such a way as to allow for some choice in care paths or in medication utilization. In some instances, this represents a choice of whether or not to utilize a particular intervention (eg, may ask the provider to “consider” obtaining a 12-lead ECG) and in others it may be a choice of a range of dose or choice of medications to treat a particular condition (eg, β-blocker or calcium channel blocker, morphine or fentanyl, ketamine or versed).

Logical Structure

Protocol design should include a consistent organizational structure to improve utility and access for providers. If the protocols are disorganized or difficult to follow, unintended delays and errors could occur when providers seek to reference them during patient care. A logical structure and organization of protocols also aids in protocol review and revision efforts.

Required Documentation

There are a number of potential documentation requirements that can be considered during protocol development that should relate directly to key elements of patient care and CQI. Some elements that are sometimes required as parts of the patient care record (PCR) are depicted in Table 5-1. Documentation demands must consider a balance between provider workload and impact on patient care and input from providers and stakeholders may help delineate useful components from those that may incur less positive impact.

Defining Specialty Centers

In some locations, there are recognized specialty centers that mat be considered for primary transport destination over other (sometimes closer) hospitals in cases where there is a perceived benefit due to a particular identified condition (eg, major trauma, stroke, STEMI). In addition to evaluating the documented evidence of patient benefit the medical director and protocol development team should consider local and state regulations, as well as political and financial impacts on the system. Some states have designated centers for trauma, stroke, STEMI, and others which may mandate inclusion into the protocol, or may simply offer additional information concerning the capability of specific centers. Designing bypass into the protocol could have negative impacts and careful consideration of the criteria and provider education should occur. In addition, discussions with stakeholders should occur during the development, implementation, and redesign of this component of the protocols.

CATEGORIZATION

Categorization of protocols reflects the method used to organize the system's scope of practice and approach to various clinical challenges. While this issue appears trivial, it is an important reflection of system design, provider expectations, timing of physician involvement, and error reduction. One common categorization is general, medical, trauma, and procedural. Pediatric specific protocols are interspersed. However, another arrangement that may avoid limiting diagnostic considerations and premature closure (all chest pain becomes cardiac, all motor vehicle crashes become trauma, etc)⁵ is to categorize conditions according to acuity and severity, attempting to avoid diagnostic categorization. A sample table of contents is shown in Figure 5-4.

IMPLEMENTATION OF THE DESIGN PROCESS

Implementation of the principles discussed in this chapter results in an organized and well structured process that takes into account the key features of a system in order to ensure development of a viable protocol with high likelihood of successful implementation. The process is summarized in Box 5-4 noting the key components: need, development, draft, introduce, publish.

In some systems, protocols are revised on a regular schedule (annually, etc) while in others they are revised or introduced based on need, administrative resources, etc. There are benefits to both approaches; the scheduled system facilitates a standardized process with expectations for development, education, expense, and implementation, while the episodic system is more agile and avoids “change for change's sake.”

POTENTIAL PITFALLS

Consider avoiding the use of referencing outside guidelines in the protocol (eg, “start ACLS algorithm”). Although in most cases it is unlikely that a medical director would strongly object to an updated algorithm from a respected nation or international professional organization (eg, American Heart Association/International Liaison Committee on Resuscitation) this applies a variable to the protocols that are outside the control of the medical director and the protocol development team. This can also cause confusion among providers as to when this change would take effect and how and when they are required to obtain new training to meet this change in guideline, which is now codified as protocol due to their referencing in the protocols themselves. While reviewing protocols from other systems can be very beneficial during protocol development, medical directors should be cautious when considering adoption of another system's protocols. Even when systems are geographically nearby or under a similar set of regulatory requirements, other local factors may make this practice unsound (ie, difference in hospital capabilities, provider demographics, patient demographics, associated emergency services). Medical directors and EMS systems administrators should not underestimate the need to review drafts and gain ongoing input from field providers, supervisors, and participating hospitals during the development process. Failure to involve key stakeholders and end users in the process can lead to catastrophic failure of implementation in some cases.

KEY POINTS

• Guidelines set forth best practices as described after expert review of available evidence. They require interpretation for local implementation.

• Policies set goals and expectations. They reflect standards set by law, regulation, and accreditation requirements.

• Protocols describe methods for providing care. They should be carefully designed, categorized, and implemented. Protocols are one means to define the scope of practice and standards of care for EMS providers and agencies.

• Procedures delineate procedural detail for performance of a task. They are specific to the referenced equipment, agency, or task, and should be clear, concise, and simple.

• Scope of practice defines the range of care expected from and allowed for by a specific type of care provider.

• Standard of care is defined as the minimum acceptable quality of practice expected of a provider facing a particular situation.

REFERENCES

INTRODUCTION

Emergency medical services providers, like other health care workers, are dedicated to improving the lives of their patients. Unfortunately, even with the best of intentions, there are times where the care provided may be suboptimal. This may be the result of an error by an individual provider or a larger system issue. Providers and organizations should embrace quality improvement efforts as a means of reducing errors and improving clinical care to benefit the overall health of the patients they serve.

OBJECTIVES

• Describe the components of an EMS agency CQI program.

• Describe the components of an EMS system CQI program (local, regional, state).

• Discuss how the CQI process interfaces with protocol design (Chapter 5) and provider education (Chapter 7).

• Discuss surveillance of high-risk call types and procedures.

• Define retrospective and prospective CQI, and give examples of their use.

• Determine how patient care can be evaluated through analysis of tasks and outcomes.

• Describe how the Plan-Do-Check-Act model can be used to evaluate system changes.

• Understand the legal protections that may, or may not, be afforded to the CQI process.

• Discuss what it means to develop a culture of quality and safety.

• Discuss the importance of utilizing a Just Culture approach.

Oversight and active involvement in continuous quality improvement (CQI) is a key component of any medical director's duties to an EMS agency. CQI has been defined as a “structured organizational process for involving personnel in planning and executing a continuous flow of improvements to provide quality health care that meets or exceeds expectations.”¹ When considering CQI in the EMS system it is logical to consider the components of a quality improvement program (Box 6-1).¹ In examining a provider, agency, or system, quality measures (now better known as performance indicators [PI]) must be examined and applied to programs and initiative designed to improve quality and patient safety.

HISTORY OF QUALITY MANAGEMENT

The basics of modern day quality improvement can be traced back to manufacturing principles from the Industrial Age. As mass production spread, it was necessary to ensure products looked similar, worked the same, and had minimal flaws or defects. Initially, these principles were limited to manufacturing and other “product”-based industries. Manufacturing is often seen as a linear process where an idea is developed and ultimately sold. The actual making of the product is typically straightforward, with high repetition and limited variability. In manufacturing, quality is often considered “conformance to requirements.”² Historically, health care was not thought of as a product, but instead a process to maintain and improve an individual's state of health. In health care, the focus is typically on health outcomes and not defects in a product.

The process is individualized to the patient and situation. As a result, provider input and variability is never completely standardized.² Over time, however, efforts have been made to bring TQM principles to light in health care and are the basis for the development of CQI. When examined more generally, some of the characteristics of manufacturing TQM can again be seen in the evaluation of the delivery of modern health care. In EMS, the call taking and dispatch processes are similar to an assembly line (Figure 6-1). When quality is redefined as customer satisfaction and improved outcomes, the so-called “product” of patient care and transport is more easily assessed. While the focus on improving efficiencies can apply in the EMS setting, the main focus is on reducing errors and improving patient outcomes.

KEY POINTS IN THE DEVELOPMENT OF MEDICAL QUALITY

Two very important publications lead to a significant cultural impact on physicians and the health care system that helped drive the system toward evidence-based medical practice and quality assessment. The Flexner Report (published by Abraham Flexner in 1910) exposed the serious failings of the American medical education system and detailed some of the major deficits in the practice patterns of American physicians. The resulting pressure from the American public strengthened the mission of the newly founded Council on Medical Education and a large number of medical schools were closed and the number of schools was less than half in just 25 years after the report. Around the same time Dr Ernest Amory Codman was pushing for hospital reform and advancing his idea of the “end-result system.” He was possibly the first doctor to champion an organized system for evaluation of the outcome of medical practice on patients and advocated not only for the use of this information to guide medical practice, but also believed the information should be made public so that patients could choose their doctors and hospitals based on their outcome performance. Sir William Osler is credited with many accomplishments that advanced medical education and patient care, including moving medical student education the bedside, creation of residency training, and emphasizing the importance of the patient interview. Dr Olser has also been credited with introducing morbidity and mortality discussions to standard medical education for students and practicing physicians. In 1952, the Joint Commission on Accreditation of Hospitals (JCAH) was formed and began its work based on evaluation of hospital-based medical care and the policies and procedures that guided patient safety, leading to an “accreditation” that now has significant financial implications based on eligibility for reimbursement for care provided. Standardization and benchmarking of modern hospital patient safety efforts have been credited to this organization and their accreditation process. Most EMS medical directors know this organization as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO); however, they have changed the name again, and it is now known as The Joint Commission (TJC). Dr Avedis Donabedian's work in the 1950s to 1960s to develop an organized study and approach to health care quality is also a key component of the development of the modern CQI process. His 1966 paper entitled “Evaluating the Quality of Medical Care” is still considered an important work for study.

MODERN QUALITY MANAGEMENT STRATEGIES

In many ways the worlds of corporate business and medical practice are now intertwined, and as the recognition of medical care as an industry has matured they have increasingly been recognized as sharing many quality management goals. The pioneers of the modern quality management movement included W. Edwards Deming, Walter Shewhart, Joseph Juran, Philip Crosby.^2,4 Deming and Shewart developed the Plan-Do-Check-Act (PDCA) model (described later); Juran was among the first to directly link the quality improvement processes of manufacturing to the health care setting.⁴ Juran also broke the process down into three steps: quality planning or ensuring the process will meet standards; quality control or checking to make sure the product is correct; and quality improvement, focusing on making the process and product better.³, These strategies were building blocks of the modern concept of total quality management (TQM) described in 2001 by Cua, McKone, and Schroeder that went beyond these principles and pulled in concepts relevant to customers and supply as well; however, this is not always easily translated into a program focused on patient outcomes.⁵ There are also several other well-known names associated with the principles of quality improvement, including ISO 9001:2000, Six Sigma, and Baldridge. Both Six Sigma and Baldridge have been studied and applied extensively to hospital settings, with degrees of success in improved efficiencies and processes.^6,7 The Lean methodology, commonly combined with Six Sigma, relates to streamlining processes and is not necessarily germane to the focus of patient safety and CQI in EMS, however, may be employed by administrators managing the operational components of an agency or system. These concepts can be compared by their component areas of focus (Box 6-2). Box 6-2 Comparison of Quality Improvement Concepts

EMS CQI AT MULTIPLE LEVELS

It is important for the EMS physician and medical director to recognize that key personnel and leadership at multiple levels of the EMS system must be actively engaged in CQI. Each level of organization has slightly different ideal roles in the overall system and participants at these levels must be careful to maintain their focus on important task relative to the particular level of CQI being performed. Although the highest level or system administration could attempt to perform, or be directly involved at all levels, this would prove impractical and very inefficient.

AGENCY CQI

At the agency level the CQI committee and other key personnel should consider focusing on surveillance and improvement of specific provider PI and the overall performance of the agency. Individual providers should be compared to their peers using statistics (usually evaluating for a deviation from the mean) that can allow CQI committee members and the medical director to identify individual providers that may need additional education of remediation in the identified areas. In addition, agency level CQI should include review of the agency means for PI and consider comparison to other agencies in the system or to national benchmarks. Derivation from these means could signify a need for agency-wide education and/or process improvement. CQI done at this level allows for understanding of procedural detail that may be causing some poor performance and members may be able to derive specific initiatives or process/procedure changes in an effort to improve outcomes.

SYSTEM (COUNTY/REGIONAL) CQI

At the system level, the focus should shift to evaluation of patient outcomes and the review of policies, procedures, and protocols that affect overall delivery of patient care. In some cases, a county or regional level agency may have a regulatory duty/authority over individual provider CQI when certain types of errors are made or other criteria are met. This may also be a function of state-level CQI and may result in the suspension of privileges or revocation of licensure. CQI at this level should also focus on the sharing of PI findings among agencies in the system. Errors should be reviewed in an effort to alert other agencies to the possibility of similar problems, and for the purpose of sharing quality improvement initiatives. This level of CQI should also be used to demonstrate examples of exceptional care, and to share this information with other agencies for their benefit by modeling examples of successful practice.

STATE CQI

Some functions of the state-level CQI may be somewhat similar to the system-level program; however, the state usually has regulatory authority concerns that guide the particular goals of CQI. Protocol review, narcotic diversion issues, scope-of-practice determinations, licensure concerns, and grant funding programs aimed at supporting quality improvement and best practices may all be the focus of CQI at this level.

NATIONAL CQI

Establishing national standards and setting benchmarks for PI are among the CQI goals at the national level. In some cases, nation-wide CQI efforts may guide the legislative process, set criteria for receipt of grant funding, and alter the parameters for reimbursement from Medicare and Medicaid. The National EMS Information System (NEMSIS) database serves as a platform for data collection for research into trends and could be used to assess value. Value in health care is usually defined as the impact of an intervention, or a PI, divided by the cost of the intervention or service. This concept could also be developed into a methodology by which EMS agencies reimbursement could be transitioned to a pay- for-performance model.

QUALITY ASSURANCE VERSUS IMPROVEMENT

Quality assurance is defined as, “retrospective review or inspection of services or processes that is intended to identify problems.”³ In this process, the review begins after an event has occurred, and the focus is often on the actions of individual providers measured against some standard or threshold. Providers receiving feedback may consider it punitive or subjective. Some quality can be achieved with quality assurance, but the effect is often to settle for “good enough” if a subjective standard is met.⁸

CQI focuses on the improvement of processes, systems, or organizations as a whole.³ Individual providers may be the focus of education and training, but most focus is on the systemic problems with a process. The improvement process is data driven, and the focus is in education and improvement, not discipline.⁸

In medicine, CQI principles are seen prominently in clinical practice guidelines.⁹ Guidelines are developed using best practices to improve the processes of patient care. These guidelines help decrease the types of variations in clinical practice that can lead to poor outcomes. In EMS, providers practice understanding orders or protocols supplemented by online medical control orders. Protocols can be considered similar to clinical practice guidelines, though it is important to ensure protocols are based on up-to-date information.

MAKING QUALITY A PRIORITY

With limited budgets in EMS, the focus tends to be drawn toward reacting to the present crisis. Thinking of quality in general is a proactive process. This makes planning, budgeting, and prioritizing quality improvement activities difficult. Quality assurance, at minimum, is often a requirement at the state level for ambulance service licensing/ certification.¹⁰ Many states require evidence of or participation in activities such as patient care report reviews, data collection, continuing education. Organizations may choose to go no further than the required quality assurance activities, but this will not result in improvement. Quality improvement starts with the deliberate decision by an organization to be proactive in improving the patient care it provides.

Since the 2006 Institute of Medicine report “Emergency Medical Services at the Crossroads” a greater emphasis has been placed on developing system-wide (and nation-wide) quality improvement initiatives with established benchmarks for PI. In addition to agencies' and providers' interest in ensuring high-quality patient care, and the desire to maintain regulatory compliance, there is also a possible direct financial consideration that can justify an increased focus on CQI. Based on the “pay-for-performance” reimbursement model that continues to become an ever-greater influence on health care finance, these PI are likely to become the basis for reimbursement in the future.

EVALUATING TASKS

One way to evaluate care is by task performance. EMS protocols lend themselves well to this type of evaluation by providing benchmarks. A reviewer can turn to the appropriate protocol for a chief complaint and compare the protocol to the actual care performed. A similar task-based evaluation is common in practical skills testing. While this method is useful, the binary “did” or “did not” approach to procedures may lead to an oversimplification. It may also fail to recognize how well the procedure was performed, or whether it was done at the appropriate time during the encounter.

When a case is reviewed retrospectively, some tasks are easy to point out when they are done versus when they are not done. Spinal immobilization is one task that traditionally has been easy to review retrospectively when not performed. The lack of immobilization in the setting of a significant mechanism raises a red flag, which is easy for a reviewer to find. Conversely, it may be difficult for a reviewer to identify a case where spinal immobilization was performed though not indicated. Spinal immobilization will continue to be an important topic of conversation as the EMS community continues to focus on the iatrogenic effects of immobilization and has moved away from reflexive immobilization of all trauma patients.¹¹

Administering dopamine to a hypertensive patient is a clear error of commission. However, evaluating a patient with a mild allergic reaction who receives epinephrine inappropriately may be more difficult to evaluate. The patient may have been adequately treated with diphenhydramine, but the reviewer may be unable to determine this retrospectively from a case review.

Medication errors have been well studied in the hospital setting and are estimated to account for one of the largest portions of preventable medical errors.¹² While usually only one patient is being cared for in the EMS setting, the other medication “rights” still apply and errors can occur with these. A medication could be given in the wrong site, such as IV access obtained in the same arm as a fistula; the wrong concentration, such as epinephrine 1:1000 versus 1:10,000; the wrong route, such as IV versus IM administration; or the wrong medication, such as with two similarly shaped or colored vials. Evaluating the tasks associated with medication administration ensures that potential errors are recognized, and processes can be improved if needed.¹³

When evaluating the events that make up an error, a root cause analysis (RCA) style approach can be considered. The nature, magnitude, and the timing of the error are all potentially important to determining the root cause(s). RCAs usually require a team approach and it may be helpful to construct a patient care timeline from available data and documentation. In some cases, multiple root causes may be identified. As in RCA for production and business, the CQI RCA should result in identification of causes that can then be addressed by remediation, education, and institution of preventative measures. The goal is to reach proactive solutions, rather than simply deriving reactive ones.

MEASURING OUTCOMES

Outcome-based reviews are important for all health care professionals. Outcome measures are especially difficulty for prehospital providers who have a single, brief interaction with their patient. There are some changes that can be measured in transport: return of spontaneous circulation (or loss of pulse), improvement in vital signs, and reduction in pain are all potential short-term outcome measures that can be identified within a single EMS patient encounter. However, these may not always reflect the patient's long-term outcome.

Many EMS providers have traditionally held the myopic view that any patient who is “alive when we get to the hospital” is a success. In truth, a patient dying during transport because of an error, though critically important, is probably fairly infrequent. These events must be reviewed extensively when they do occur. Morbidity or mortality later on as a result of prehospital care is more likely. Improper oxygenation of a head injury patient, leading to a poor neurologic recovery, is one such example. Obtaining feedback from the hospital allows agencies to better understand the bigger picture and their role in the overall care of the patient.

Hospital feedback is especially important in missed diagnosis/missed identification of conditions. For example, an agency may believe it is treating ST-elevation myocardial infarction (STEMI) patients correctly if a review of their records shows that 100% of patients with a provider impression of STEMI are taken to a PCI-capable center. Unfortunately, such a review is limited to cases where the provider had correctly identified the patient condition. This type of review would overestimate compliance by only reviewing cases where a diagnosis was made. Without hospital feedback, the agency may miss cases of STEMI that were not identified in the first place and as a result taken to an inappropriate destination.

CHOOSING WHAT CASES TO REVIEW

What cases are reviewed is key issue for any QA program. While some programs strive for 100% case review, resource constraints often hamper the ability to perform a meaningful review on all calls. A random sampling of calls is a good way to begin any review. By creating a sampling protocol that provides a mixture of call types and providers, the sample will reflect the overall composition of patient encounters. In addition, certain high-risk conditions, high-risk procedures and high frequency events may warrant increased scrutiny. A breakdown of procedures by risk and frequency can be useful in analyzing where a CQI program's attention should be focused. A set list of triggers for 100% case review should be created by the CQI staff in conjunction with the medical director. An example of such a list is seen in Box 6-3; please note that a single case may fall under multiple triggers.

EXAMPLE: INTUBATION

Intubation is a high-risk, low-frequency skill that should be scrutinized in all EMS quality assurance programs. The desire to provide patients with a definitive airway is balanced by the alarming rates of procedural failure. Tracking the intubation success rate is one important step. Intubations success rates should be monitored on an individual call, provider and agency level (and perhaps a system level). Quality in intubation, like most complex skills, goes beyond a simple “success/failure.” The number of attempts required, time spent on each attempt, as well as the resulting trauma to the airway, hypoxia, and the time opportunity cost of not performing other tasks (such as CPR) are all adverse events associated with intubation attempts.¹⁴ In addition to chart review prospective CQI, including use of scenarios and simulation, should always be a component of the review process as chart review alone is inadequate for revealing potential deficits in provider proficiency in these types of high-risk, low-incident procedures.

REVIEWING COMPLAINTS

Complaint-driven reviews may originate from patients, families, hospitals, first responders, crewmembers, or the providers themselves. Though patients and families may not understand the intricacies of patient care, their concerns are no less valid. Often their complaints stem from a nonmedical concern such as crew demeanor or rough patient handling. It is reasonable to review all such cases from a medical perspective. A review of seemingly nonmedical complaints may reveal clinical errors. Hospitals and other first responders are other important sources of feedback. Complaints that originate from fellow crewmembers are often the most concerning. Partner complaints must be investigated extensively, and whenever possible, with sensitivity for the confidentiality of the reporter.

SELF-REPORTING

A culture that encourages self-disclosure of errors is important part of a CQI program. Due to concerns of embarrassment, liability, or job action, a provider may choose to hide or at least not disclose an error. From an individual perspective, the provider may lose an opportunity to grow as a professional. From an agency perspective, it may mask a larger systemic issue within the organization. Few agencies have 100% call review, and even those that do will not pick up every error. Policies that protect individuals who self-report their errors from discipline or termination assuage some of the concerns surrounding self-reporting. Such policies should protect providers who make good faith efforts, with possible exceptions for intentional or fraudulent acts. In jurisdictions where there exists local, regional, and/or state oversight of quality there are typically criteria for what types of errors require reporting to these regulatory authorities. When an agency has discovered it has committed an error or regulatory violation, self-reporting incidents that require regulatory review is usually advantageous and shows initiative and a willingness to comply with review and remediation. In the case of provider errors that must be reported, agencies should strongly advocate for their providers to self-report to the agencies and should make it a point to include this fact when forwarding to regulatory organizations (eg, New York State Department of Health Bureau of Emergency Medical Services).

NONCLINICAL EVENTS

Response times are historically the most scrutinized metric, yet paradoxically, they are the least related to direct patient care and have not been shown to represent quality in patient outcomes. Response times have been embraced because of their ease of monitoring despite this fact and are commonly a component of a municipal contractual obligation. Systems use fixed (although varied) starting point for this interval which ends when a unit radios it is on the scene. There is little room for interpretation as this is a discrete value. The response time can then be measured against a predetermined standard to determine compliance. Response times are internally monitored because they are closely scrutinized externally by municipalities, contracting agencies, the media, and others. This should not be a benchmark for the CQI process, but may be tracked due to monetary contractual concerns of the agency administration.

Stretcher Drops and Ambulance Response Collisions are important causes for harm for patients, responders, and the community.^14,15 These are generally seen as operational issues, and not under the direct review of the medical director or the CQI committee. If an agency chooses to review these events outside of their CQI system, they must still ensure these cases are treated with appropriate attention and scrutiny.

PLAN-DO-CHECK-ACT MODEL

CQI can be used to evaluate system change in a circular manner.

The classic model developed by Shewhart and Deming and used in CQI is Plan-Do-Check-Act, or PDCA.¹⁶ In this model, each step flows into the next and is a continuous cycle (Figure 6-2).

Using a defined model helps prevent the improvement process from being arbitrary. When time, money, and effort are being expended, an organization should strive to develop the most efficient and well- designed program, process, or improvement. A model helps guide our process and thinking so we can focus on the steps necessary to affect change. This also prevents an all too common occurrence: the “great idea” model of improvement that is not data driven or fact based.

The PDCA model is especially helpful when planning a new improvement project or work process. It should also be utilized whenever implementing a change, defining a repetitive work process, and planning data collection and analysis. Anytime there is change or improvement involved, the PDCA model can be applied.

PLAN

The basic steps of the PDCA cycle follow the names given to them. The first step is to recognize that an opportunity for improvement exists and begin planning the improvement process. The foundation of planning is the process of assessment, including needs assessment or situational assessment. During the planning phase, multiple different techniques may be employed in an effort to derive potential solutions. Creative development techniques such as brainstorming, the Delphi method, value engineering, morphological analysis, and others should be employed during this phase to ensure a breath of ideas have been considered and explored.

DO

The second step is beginning implementation of the plans. This is also the step to begin testing and reevaluating the plan set forth based on your assessment. Note that incremental changes are more easily accommodated and tested. “Pilot” programs or projects are useful to work out the kinks identified in the planning stage.

CHECK

It is important to step back and evaluate the successes and weaknesses of the plans you have implemented. The check is essential to the improvement process—without looking at the lessons learned from a pilot program or testing of implementation, we cannot improve in the next iteration.

ACT

Using what has been learned or discovered from the previous three steps, we must take action and begin the planning phase again. Have we met a “best practice” standard? What else could be done to improve? Be prepared to go through this process repeatedly and continuously—incremental changes and improvements are more easily attained than a complete overhaul.

PROTECTION FOR CQI DOCUMENTS

While protection for quality assurance and improvement proceedings are clearly enumerated for physicians and the hospital setting, these protections are less defined in the prehospital setting.¹⁷ Major concerns include whether CQI processes are discoverable, the extent of protection provided to those performing CQI functions, and how CQI documents may be used in disciplinary action against individual providers. CQI documents may include data gathered, such as the patient care reports or statistics on providers; written records of audits, improvement plans, and investigations; and written or oral deliberations, disclosures, and statements.

Confidentiality of CQI records, both from legal proceedings as well as for individual providers, should be addressed specifically in setting up a CQI program. Some states may address the issue of confidentiality for documents produced or related to CQI in the EMS setting, and additional research into the state of practice laws is essential. The EMS agency type—for example, a municipal service that falls under “freedom of information” disclosure rules, a hospital-based system using an existing review board, or a private entity that may function independently—may also determine what protections apply.

With a hospital-based system, prehospital CQI activities fall under umbrella of the hospital's existing peer review mechanism, which may alleviate some concerns over the discoverability of CQI documents. State statutes may exist that allow confidential review by a centralized party, while others may allow for confidential review by the individual EMS agency.

To help strengthen the case for confidentiality of documents produced by CQI activities, the CQI program should specify how documents are produced, stored, distributed, and protected. Policies and procedures should be written specifying the private and confidential nature of CQI documents and information, including the use of a watermark or other means to mark documents used for CQI if possible. The program staff should be defined, and responsibility for data collection and analysis determined. Finally, documents should be securely stored and protected against unauthorized distribution.

The Health Insurance Portability and Accountability Act of 1996 specifically allows for the sharing and use of patient information without individual authorization for health care operations including “quality assessment and improvement activities, including case management and care coordination.”¹⁸ This includes the sharing of hospital data with an EMS agency for the purpose of EMS quality assurance.

LIMITATIONS OF CHART REVIEWS

A common method of retrospective quality assurance and improvement is review of the patient care record, or PCR. A PCR may be handwritten on paper forms or electronic. With the advent of electronic medical records and “ePCR,” data mining and reporting is even more accessible and useful. Regardless of the method of documentation, PCRs are the foundation for gathering data from the field. Limitations to PCR reviews do exist and must be acknowledged to prevent misuse of the possible data.

The PCR is a record of what happened and what actions the provider may have taken on a call. Documentation is often completed after the patient care has ended—hopefully immediately after leaving a patient's side but could be potentially hours to days later. The record is only as accurate as the information gathered and inputted. If a provider purposely or accidentally fails to include details such as assessment findings or treatment provided, these data are not captured and cannot be analyzed. Unfortunately, it is not uncommon for providers to omit an unsuccessful IV attempt from the PCR, for example, thus skewing the data for reporting. When using paper forms, documentation can be inconsistent, incomplete, and illegible. Even if accidental, missing data elements may prevent accurate reporting and statistics. Similar to the possible lag in documentation, review of the PCR is usually not in real time. Typically, days or even weeks may pass before a call is reviewed by CQI. Potential quality issues may not be uncovered in time to prevent another incident.

While reviewing a PCR, it is important to remember that the intricacies of patient care may not have been precisely described. A provider who struggles with documentation may be unable to relate what happened effectively. Additional information can be obtained through the audit process or interviews. Poor documentation does not always mean poor care was provided, and conversely, poor care can be provided even with excellent documentation.

PROSPECTIVE CQI

Prospective CQI refers to the active review of provider skills, policies, protocols, and procedures. Evaluation and CQI relative to policies, protocols, and procedures should be a component of the protocol development process; however, CQI committee members should forward any findings relative to system errors and negative impacts that can be tied to these documents. Regular evaluative activities including, but not limited to, oral exam scenarios, high-fidelity and low-fidelity patient encounter simulations, and skills check-offs are examples of potentially high-yield prospective CQI. Conducting surveillance of the agency providers and identifying the agencies' potential deviations from regional, state, or national benchmarks can lead to increased continuous medical education efforts in identified areas. This increased educational component should also be accompanied by evaluative tools to ensure efficacy.

IDENTIFICATION OF ERRORS

When an error is discovered, by any process, it is important to define the error in terms of the general type of the error. This is usually considered a two-component system: (1) provider error and (2) system error.

PROVIDER ERROR

Provider errors are those directly related to a failure of the individual to perform the correct actions and could represent an error of omission or commission. The causes of this type of error can be of a number of types, including educational deficit, skill incompetence, impairment (substance abuse, emotional distress, fatigue), negligence, reckless conduct, malicious intent. These errors can be further characterized as diagnostic (error in diagnosis/field impression, failure to perform diagnostic intervention, or failure to act on results of monitoring or testing) or therapeutic (error in the performance of a procedure, error in administering a treatment, error in the dose or administration of a drug, or providing a therapy that is not indicated). Evaluation of underlying features (or root causes) and choosing the appropriate response to the error is discussed further in the section Just Culture in this chapter on Just Culture.

SYSTEM ERROR

System errors are those that stem primarily from process failures that allow for otherwise preventable occurrences. In some cases, processes and/or policies themselves create confusion or develop into new risk for error occurrence. When an error is identified that should have been prevented by a better process, policy, or protocol, this is referred to as a system error. The distinction is important, in that remediating one provider based on a patient care error that was primarily a system error, not only does not aid in enhancing the provider's ability to care for future patients, but it also fails to prevent another provider from encountering the same situation and potentially committing the same preventable error. It is crucial when reviewing cases of medical error that the determination be made concerning the presence of provider error and/or system error. If both types are present, then both must be addressed. An example would be a case in which a medication shortage led to the stocking of the same medication in a different (higher) concentration. The provider draws the same volume and mistakenly injects twice the dose due to the high concentration. It is then easy to see that the provider failed to check the concentration and ensure administration of the correct does; however, there was a lack of system safety policy to alert the provider to double-check the dose due to the replacement stocking. The system failed to provide for patient safety, when simply marking the vials with sticker or packing them in such a way as to identify them as being different than the usual concentration. Other system errors include failure of communication and equipment failure.

REMEDIATION

Remediation is not a disciplinary action, but rather a customized educational program aimed at enhancing provider knowledge and/or skill in a determined area of deficiency. This concept is covered in Chapter 7 and Chapter 27. Remediation should be carried out by the training director, medical director, or other appropriate designee, but should ideally not be the duty of any member of the CQI committee that was or will be party to CQI review of the same provider, or by the individual who is known to be responsible for instituting disciplinary action.

LIABILITY

Liability is an important concern for those performing CQI functions, as well as EMS agencies in general. The goal of any case review should be to have a candid discussion with the providers. Many barriers may exist to having an open, candid discussion. Fear of discipline, termination, legal liability, and professional embarrassment are all potential concerns for individual providers. CQI should be used to improve patient care, not for disciplinary reasons, and any data gathered or improvement plans required should be shared only with those necessary. In instances where discipline or termination results from CQI review, confidentiality and adherence to proper human resources procedures may be helpful. If implemented incorrectly, it is possible for the medical director to suffer from legal action related to claims on the part of the provider of a lack of appropriate due process or even defamation of character. Because the CQI process can lead to reduction in (or removal of) authorization to practice, it is possible to claim that the medical director has interfered with the providers' property (license) or their ability to conduct business. Therefore due process must be followed and CQI procedures must be clear and clearly followed. In order to avoid suit brought under Federal Civil Rights Statute 42 USC 1983, the medical director must ensure due process—(1) notice, (2) hearing, (3) opportunity to challenge, (4) fair and nondiscriminatory process. If the CQI process is not properly protected or not kept confidential, a provider could claim that the medical director is to blame for loss of fame (reputation and respect) that could impact their state of mind and ability to earn an income and could then bring suit against the medical director and agency for defamation of character.

ELECTRONIC MEDICAL RECORDS

Electronic medical records streamlined quality assurance programs.¹⁹ What used to take hours of meticulous hand searching through patient records can now be done automatically via computerized reports. Once a report is written, it can be applied to various time periods, allowing a similar search to be done quickly at a future date. Electronic patient care records typically have a mixture of free text sections and defined fields. Although some free text can be searched by individual word or by hand, encouraging or mandating crews to use defined fields improves the ability to review specific interventions. Predefined subfields allow further review of particular interventions. This allows review of overall success rates of procedures for an agency or a particular provider. Tracking intubation success rates is one frequently measured procedure. Finally, the use of closed call rules can ensure all preselected fields are entered before the electronic PCR is completed.

As electronic patient care records become more popular, the NEMSIS will allow us to begin looking at data from prehospital encounters all over the country. NEMSIS is a data repository designed to collect patient data from every state to allow for reporting on a state and national level. This national data set will permit research into evidence-based prehospital interventions and benchmarking of PI. Most prehospital electronic records systems are designed around the required NEMSIS data points, though not every state and agency is able to submit data at this time.²⁰

SETTING UP YOUR CQI TEAM

How a specific EMS organization sets up the CQI team may depend on local, state, and company guidelines, but there are two general paradigms—a CQI committee or a CQI person.

A committee draws upon the experiences and background of multiple stakeholders to help guide a service in its improvement activities. Ideally, the committee should consist of the service's medical director, several members of the management, and several field providers at all levels of practice. Additionally, stakeholders in the surrounding medical community, such as hospital staff or other public safety personnel, may be included. Decisions and activities are guided by the committee, though single members may be responsible for tasks such as PCR reviews. The committee must meet regularly to be effective, thus potentially being a significant time commitment to its members.

If a committee is not possible, a single provider may be assigned to perform CQI duties independently. This should be an experienced provider who is able to build and maintain relationships with providers, management, and local hospitals. This person would be responsible to guide the organization toward quality improvement, as well as tasks such as PCR reviews, data collection and reporting, and investigations. The use of a single person may be more cost-effective but prevents buy-in from providers and other stakeholders.

A blend of the two paradigms is possible, with a “CQI coordinator” becoming the leader of a guidance committee. The CQI coordinator would regularly meet with stakeholders, but would be responsible to lead the organization and CQI department. Organization size and workload may necessitate additional members of the CQI team to assist, but the coordinator acts as the champion to put everything together.

QUALITY ASSURANCE PITFALLS

Quality assurance and similar medical direction activities are often outside of collective bargaining between an organization and its employees. Similarly, quality assurance activities also provide a level of protection for disclosure, which operational activities do not enjoy. As a result, an organization may be tempted to move activities unrelated to CQI under the CQI umbrella. In doing so, the medical director may be drawn into issues that are outside of his or her purview. Establishing clear expectations for an agency's medical director and CQI program will prevent issues of under- or overreach later on.

CULTURE OF QUALITY AND SAFETY

One of the most important components of a successful CQI program is to work toward development of a culture of quality and safety. Focusing on group delivery of initiatives and ensuring education and encouragement are included in every change to the system. Group consensus building can lead to improved communication and employing such techniques as affinity grouping and utilizing surveys, town meetings, and small group discussions ensures an appreciation for the need to establish communication at all levels. The Agency for Healthcare Research and Quality (AHRQ) states that five basic features must be present for this type of environment to exist (Box 6-4).²¹ The development of this culture also requires a support of another concept known as Just Culture.²²

JUST CULTURE

The recognition of four different behavioral causes of individual provider error leads to a more “just,” and arguably more effective, response to each error event. The recognition and participation of members of the agency lead to increased trust in the CQI process and the eventual increase in self-reporting and the recognition and reporting of near-misses and process failures. The CQI personnel must first consider these behaviors: human error, negligence, reckless conduct, and intentional rule violations. (Box 6-5)

ERROR-PRODUCING BEHAVIOR

This section describes the four types of behavior that contribute to commission of an error. It is important to note that a medical error may be related to the presence of one or more of these behavior types. Human error is when an individual is recognized as having done something other than the desired course of action, which then resulted (or could have resulted) in an undesirable outcome. Despite the outcome, these events need to be considered carefully, as they may be due to fatigue or knowledge gaps that could otherwise have been avoided, or can be avoided in the future. This type of error implies that the provider could not have detected the error prior to performing it and should result in a review and remediation to allow for improvements in the provider's performance. If the provider is found to have been impaired by substance abuse and/or emotional disturbance, they should be referred for appropriate medical and psychological care and counseling. Provider impairment is also discussed in Chapter 8. Negligence is the concept that the human error was performed by an individual that should have recognized the risk inherent to the action and is therefore culpable for the outcome. Reckless conduct is when the provider chose to disregard the risk, even when it was apparent to them, and is also known as gross negligence. Intentional rule violation is the act of knowingly and willfully acting in a way that is contrary to the rules, policies, or procedures. When a provider does this, they display their disregard for the authority of those who have established the rule and for those the rule is meant to protect. There are three ways to respond to these behaviors: outcome-based, rule-based, and risk-based decision making.

DECISION MAKING

In outcome-based decision making, a provider would receive remediation and/or disability action based on the outcome of the error. Because of the tremendous potential for the provider to only be corrected when their errors result in harm, and the potential for a minor error to result in a major outcome issue, this is probably the least “just” and least prospectively effective method. For example, if an individual were to knowingly give an IV β-blocker multiple times during a transport and ignore the protocol requirement for cardiac monitoring and repeat blood pressures and the patient had no significant detected harm from the intentional rule violation and reckless conduct of the provider, then there could be determined little to no need to provide remediation of discipline and the providers would have no incentive to correct their behavior, potentially leading to future harm or death of a patient.

In rule-based decision making, a provider who breaks a rule is found to require remediation and/or discipline based on the infraction alone. This may have the desired outcome for the example provider above whose rule violation was risky and potentially life-threatening to his or her patient. However, if the breaking of the rule is judged on its own, then infractions of rules in an effort to comply with operational norms or patient needs may also result in remediation and/or discipline that does not suit the circumstances. For example, if a provider fails to fully restock the ambulance after a call with nonessential items in order to respond from the hospital to a high-priority call for which there is no other available unit, that provider has knowingly committed an intentional rule violation. However, this behavior is more beneficial to the patient and the system than strict adherence to that particular rule.

In risk-based decision making, the inherent risk of the behavior is the major factor in assigning the need for remediation and/or discipline, in that it focuses on the intent of a provider with regard to an undesirable outcome. Where a provider commits a human error there is no presumed level of inherent risk to their behavior and therefore was not an obviously preventable act. In a case where a provider commits gross negligence through reckless conduct they have committed an error with a high level of risk and would then be subject to remediation and discipline, possibly with the emphasis on the disciplinary action due to the grave nature of the knowing acceptance of risk toward the patient and the need for the agency to maintain standards among its providers. In the case of straight negligence it may be significantly unclear how much remediation verses discipline is warranted and there may be a need for both depending on the particular reason that the provider was unaware of the perceivable, yet unperceived, risk. The risk-based approach supports Just Culture as the preferred method on which to base these decisions.

MASTERING JUST CULTURE

The volume of work in this area is staggering and is beyond the scope of this chapter. However, those EMS physicians seeking to involve themselves in CQI at the system level and/or are involved in the active development of health policy should spend considerable effort toward achieving greater mastery of this area. Reviewing and understanding the work of Reason (Reason culpability Decision Tree, Reason Foresight test) and Hudson (Just Culture diagram) may enhance this process.^23–25 College and graduate level classes, as well as webinars and seminars, are available on these topics.

PERFORMANCE INDICATORS

One of the important features of prospective CQI is the ability to look for trends or areas of improvement without the alert of a particular incident or even recognizable poor outcome. In order to perform meaningful system surveillance, PI must be developed in order to gather and analyze data leading to discovery of trends and the establishment of baselines and benchmarks.

NFPA 1710

As expected, this standard was developed for fire services, but does contain standards for EMS activities. The standard recommends a 4-minute response time for first responders and an 8-minute response for ALS. In addition to this arbitrary designation, the standard also calls for no less than two paramedics and two EMTs for every ALS activation. The standard also requires the existence of a quality review process and a medical director to oversee this process. Conflicting studies exist on the effect of response times and therefore utilizing the only PI in NFPA 1710 for routine CQI would seem less than advantageous.

NHTSA MEDICAL SERVICE PERFORMANCE MEASURES

In response to the lack of meaningful PI and the need to express a uniform set of quality measures to the medical community, administrators, payers, and policy makers, the National Association of State EMS Officials (NASEMSO) and the National Association of EMS Physicians (NAEMSP) partnered with the National Highway and Safety Administration (NHTSA) to develop a system for standardized PI development. The document “Emergency Medical Services Performance Measures: Recommended Attributes and Indicators for System and Service Performance” was published in 2009 and broke down PI into areas of focus: system design and structure, human resources, clinical care and outcome, response, finance/funding, quality management, community demographics. The 30 PI that were developed for data collection and review were derived through expert opinion and review of the literature (Box 6-6). Box 6-6 NHTSA Medical Service Performance Measures

1. Annual turnover rate

2. Average defibrillation time

3. 90th percentile defibrillation time

4. Average initial rhythm analysis time

5. 90th percentile initial rhythm analysis time

6. Major trauma triage to trauma center rate

7. Pain relief rate

8. Pain worsened rate

9. Pain unchanged rate

10. PARKED pain intervention rate

11. 12-Lead performance rate

12. Aspirin administration for chest pain/discomfort rate

13. ST-elevation myocardial infarction (STEMI) triage to specialty center rate

14. Mean emergency patient response interval

15. 90th percentile emergency response interval

16. Mean emergency scene interval

17. 90th percentile emergency scene interval

18. Mean emergency transport interval

19. 90th percentile emergency transport interval

20. PARKED per capita agency operating expense

21. PARKED patient care satisfaction rate

22. Patient care satisfaction survey rate

23. Rate of appropriate oxygen use

24. Undetected esophageal intubation rate

25. Delay-causing crash rate per 1000 EMS responses

26. EMS crash rate per 100,000 fleet miles

27. EMS crash injury rate per 100,000 fleet miles

28. EMS crash death rate per 100,000 fleet miles

29. EMS cardiac arrest survival rate to ED discharge

30. EMS cardiac arrest survival rate to hospital discharge

CALIFORNIA EMS SYSTEM CORE QUALITY MEASURES

The Emergency Medical Services Authority of the California Health and Human Services Agency has developed a set of “core quality measures” relating to 10 different areas in which they sought to measure as PI: trauma, acute coronary syndrome/heart attack, cardiac arrest, stroke, respiratory, pain intervention, pediatric, skill performance by EMS providers, EMS, response and transport, public education bystander CPR. The project was designed to test and develop data gathering and analysis from across the state and to compare California to the national data through submission to the NEMSIS. The design of the investigation included data gathering from April 2012 to April 2013 and included specific PI values (Box 6-7).

FUTURE OF PERFORMANCE INDICATORS IN EMS

Hospitals are being reimbursed based on PI in more situations than ever before. No such measures currently exist for EMS operations that link reimbursement to quality of care provided. Federal and commercial payers, such as the Centers for Medicare and Medicaid Services, may begin to apply the same type of focus on quality prehospital as in hospital patient care. Measures may include out-of-hospital cardiac arrest survival rates, response times, patient satisfaction, and transportation to the appropriate facility.²⁶

EMS is also in a position to assist hospitals in meeting their PI. Strengthening EMS protocols for STEMIs will help reduce door-to- balloon times, for example. In addition, the growing field of community paramedicine has potential to reduce emergency department visits and hospital readmissions. A randomized controlled trial in the United Kingdom showed that adequately prepared paramedic practitioners were able to safely provide basic care and follow-up for elderly patients without the need for transport or hospital admission.²⁷ CQI in EMS can help foster relationships with hospital partners while improving the care we provide to every patient we encounter.

SUMMARY

Quality management originated in manufacturing and has slowly moved into the health care field. Many hospitals have adopted CQI principles and EMS has begun to move in the same direction. QA/CQI programs are often required by regulation, but are also important to assess and ensure that quality patient care is being provided. The focus of any CQI program should be on improvement of processes and practices, not disciplinary action against individual providers. The Plan-Do-Check-Act model is a continuous process used to evaluate system change. Anytime there is change or improvement involved, the PDCA model can be applied. Although CQI documents may be protected under state regulations, it is important to address the protection and confidentiality of all CQI activities in the planning process. In some states there is only limited protection for these materials. The most common type of retrospective quality assurance, chart reviews, can be hindered by poor data collection and missing information. Electronic medical records may help this process, as well as provide methods of data mining and reporting. Currently, no standard EMS specific guidelines for reimbursement tied to PI exist on a national level, though EMS can assist hospital partners in achieving their PI. Future directions may include collecting EMS quality data, for example, on out-of-hospital cardiac arrests and response times.

KEY POINTS

• Medication errors are estimated to account for one of the largest portions of preventable medical errors.

• Quality assurance and continuous quality improvement practices are a necessary component of a functional EMS agency or system.

• QA/CQI focus should be on improvement of processes and practices, not on disciplinary action against an individual provider.

• Confidential discussions and documents generated by the CQI process are usually protected as “nondiscoverable” with regard to court proceedings.

• EMS-specific guidelines for reimbursement tied to performance indicators do not currently exist on a national level.

• The Plan-Do-Check-Act (PDCA) model is a well-defined process guide for continuous quality improvement.

• Always utilize Just Culture in all CQI activities.

REFERENCES

INTRODUCTION

All US states and territories require that providers staffing EMS vehicles have successfully completed a program of initial training and passed an examination process. These providers are also required to complete continuing education in order to continue practice. EMS medical directors are responsible for the oversight of these education programs. Additionally, they should continually evaluate the actual clinical performance of their providers and, through their quality improvement process, implement an ongoing education program designed to continually improve provider practice. EMS education in the United States, although guided and supported by national guidelines and curricula, is regulated at the state level. As a result, the specific provider levels of training and the corresponding educational requirements vary from state to state. Fortunately, there are generalizations about provider education that can be made about the overall education and training processes and requirements.

OBJECTIVES

• Describe the national basis for the education of prehospital providers.

• Describe the levels of prehospital providers and typical training requirements at each level.

• Describe the types of educational organizations providing EMS education and the role of accreditation in preparing candidates for national EMS certification.

• Detail the use of high-fidelity simulation.

• Discuss the use of distance learning, including advanced self-study and Web-based education.

• Detail the development of a field preceptor program and criteria for clearing a provider for independent practice.

• Define remediation and discuss its use in educational programs and for providers identified during CQI as having additional education needs.

• Contrast National Registry certification to state-specific EMS provider certification.

• Discuss continuing education requirements and recertification pathways.

The most common levels of training include emergency medical technician (EMT) basic, EMT-intermediate, and paramedic. Many states also include some type of formal first responder training level. This training is provided by a wide variety of institutions ranging from formal degree programs in traditional educational institutions such as colleges and universities to system-based training programs. In all states, this training is, at least loosely, based on national standards, as is the standardized examinations administered either at the state level or by a national organization (new national standard levels: EMR, EMT, AEMT, paramedic).

Many EMS systems have advanced evaluation tools that medical directors can use to measure actual clinical performance. These tools are typically used by field training officers (FTOs)/preceptors to determine and institute “stretcher-side” training aimed at continuous teaching. Additionally, EMS educators and medical directors utilize a variety of mechanisms, including simulations and distance learning methodologies, to carry out their educational goals.

As with all of EMS, the medical director bears ultimate responsibility for ensuring that the education provided at both the initial and continuing levels is clinically and scientifically appropriate and up to date.

BASIS FOR THE EMS EDUCATIONAL SYSTEM

Authority for defining and regulating EMS provider education, certification, and licensure in the United States is held by each individual state. While the federal government has a role in providing technical support, it is the states that ultimately define the education required to become an EMS provider. As a result, there has historically been a large disparity between provider levels among the states, a situation that has made providing for interstate reciprocity a difficult task. Partly in recognition of this, and in response to the education vision outlined in the 1996 EMS Agenda for the Future document, the National Highway Traffic Safety Administration published the EMS Education Agenda for the Future in 2000. This document is becoming the foundation for the state's regulation of EMS education. It describes a national EMS education system comprising five related components as depicted in Figure 7-1.

The National EMS Core Content is analogous to the Model of the Clinical Practice of Emergency Medicine (formerly the “Core Content”) upon which emergency medicine residency and board certification is based. Because the Core Content defines the medical knowledge required for the profession, physician organizations such as the National Association of EMS Physicians (NAEMSP) will be primarily responsible for maintenance and revision of this document. The EMS Core Content defines the knowledge and skills required of EMS providers but does not dictate the differences between levels of providers. The distinction of what is required of each level of provider, that is, the definitions of provider levels, is described in the National EMS Scope of Practice Model. The knowledge and skills, thus divided up among provider levels, is broken down into learning objectives in the National EMS Education Standards. These Education Standards are meant to replace the prior National Standard Curriculum for each provider level. The standards are what EMS education programs and publishers will use to create lesson plans and textbooks.

Additionally, the standards will be used as the basis for what will be on the standardized examinations used for National EMS Testing. Finally, the EMS Education Agenda recommends that, as a requirement to sit for the national examination, a candidate must have completed an education program that has been accredited by a national accrediting organization.

Currently, the organization that is developing and offering national examinations is the National Registry of EMTs (NREMT). Likewise, the Committee on Accreditation of Educational Programs for the EMS Professions (CoAEMSP) is the organization that ensures an accredited education program has demonstrated that their curriculum adequately covers the material described in the EMS standards.

EDUCATION, CERTIFICATION, LICENSING, AND CREDENTIALING: WHAT IS IN A NAME?

Few things in EMS have given rise to more angst than the terms certification and licensing. Unfortunately, these terms are frequently used imprecisely, interchangeably, or incorrectly. It is important to review these terms in order to avoid this angst and understand how these different components overlap. While there may be some States that have specifically defined these terms in different ways, we will describe them here in the context used by national documents and organizations to illustrate the concepts involved. The Venn diagram in Figure 7-2 helps define the relationship between these domains.

Education refers to the knowledge and skills gained by the provider during his or her initial preparation for practice as well as his or her continuing education. Certification is provided by a national testing organization, currently the NREMT, attesting that the provider has demonstrated competence, through written and skills testing, as a “minimally competent” provider at a given level, that is, paramedic. Licensure is granted by each state to those individuals who have been certified by the testing agency. Finally, and most importantly at a system level, a licensed provider may only practice if credentialed by the local EMS medical director. In some systems, credentialing may also be referred to as authorization to practice.

PROVIDER LEVELS

The National EMS Scope of Practice document describes the four levels of EMS provider: emergency medical responder, EMT, advanced emergency medical technician (AEMT), and paramedic. Emergency medical responders have been called first responders in the past as have AEMTs been referred to with names such as EMT-intermediate and EMT-special skills. Training at each level includes didactic instruction (traditional classroom lectures), procedure labs where psychomotor skills are taught and practiced, hospital-based clinical rotations, and field-based clinical rotations. Some programs will also require a field preceptorship that is roughly analogous to a physician's internship. It is done after the student has completed all other program requirements and is focused on integration of the knowledge and skills. It is typically completed with the same field preceptor over the course of multiple shifts and, optimally, should be based on well-defined objectives with progressive clinical responsibilities ending with completely managing all aspects of the call as though they are no longer a student. Table 7-1 lists typical requirements for each provider level. While some states may require specific hours but the recommendations of the CoAEMSP is that requirements be based on achievement of specific objectives and demonstration of defined competencies rather than specific hours.

EDUCATIONAL PROGRAMS AND ACCREDITATION

EMS education is provided in very diverse fashion throughout the country with sponsoring organizations ranging from local EMS systems/fire departments and private training programs to 4-year universities and medical schools. This diversity is probably most noticeable at the basic levels (EMR and EMT) and less so at the paramedic level where there has been some coalescence behind academic affiliations. Much of the nation's paramedic education programs, and the vast majority of accredited programs, are now offered through community colleges and universities. The requirements for approval of a training program vary by level and from state to state. The specificity of these requirements also increases with provider level with the requirements at the paramedic level being more detailed than at the lower levels.

Accreditation is a widely accepted mechanism for ensuring that an educational program meets recognized standards in their educational processes. The agency recognized by the National Association of EMS State Officials (NAEMSO) to provide accreditation services is the Commission on Accreditation of Allied Health Education Programs (CAAHEP). CAAHEP is composed of multiple committees that specialize in the various allied health professions. CoAEMSP is the CAAHEP committee dedicated to EMS accreditation. NAEMSO, composed of state regulators, voted in 2010 to require CAAHEP accreditation in order to sit for the NREMT's national EMS paramedic certification examination beginning January 1, 2013.¹ CoAEMSP only accredits paramedic level programs, although these programs frequently offer options to “test out” at lower levels such as EMT.

The process of becoming accredited involves the program completing a rigorous self-study that describes how it complies with the accreditation criteria or standards. These standards are based on accepted educational processes and supported by the EMS Education Standards as published by NHTSA. The program then develops a report based on this self-study and submits it to CoAEMSP, which then assigns a trained site visit team to come review the program in person. This team then prepares a report detailing, in objective terms, the program's compliance with the standards. The CoAEMSP board will then review the site visit team's report and make a recommendation to the full CAAHEP regarding accreditation. Ultimately, it is CAAHEP that issues the accreditation. The program must then submit ongoing progress reports to CoAEMSP and undergo periodic reaccreditation similar to the initial process.

FIELD TRAINING AND EVALUATION

While the initial education, certification, and licensing of a medic are clearly very important, it is but the beginning of a continuing process of evaluation, training, and reevaluation. The medical director is responsible for this process but will likely need the assistance of FTOs. While it would be ideal for the medical director himself to perform these evaluations, it often is not feasible in all systems. These FTOs are valued employees who have demonstrated superior clinical, teaching, and interpersonal communication skills and are specifically trained to evaluate medics using objective performance criteria. The FTO process is the most accurate means of evaluating a medic's actual performance in a real-world environment. The criteria used should have several features: they should be specific, measurable, attainable, and tied to desired job-related competencies.

The evaluation process should be a one-on-one relationship between an assigned employee and a single FTO to promote continuity of the evaluation. It should begin with the FTO reviewing the criteria with the medic and ensuring that they understand what is required for successful completion. Any time-related requirements should also be reviewed, that is, “you have 2 months to achieve these objectives.” The FTO should then teach the employee the desired knowledge/skills in a didactic fashion reinforced with manikin/simulation practice. Once this has been accomplished, the FTO should demonstrate the objective and then observe the medic demonstrate the objective, after which they should provide appropriate feedback. Next, the medic should demonstrate the objective independently with the FTO providing no feedback. Finally, the medic should demonstrate the objective to an FTO not involved in his training. This process should be completed for each objective deemed critical for successful practice by the medical director. Obviously, multiple objectives may be demonstrated concurrently rather than in series. The FTO should utilize a formal tracking system for the completion of these objectives.

When providing feedback, it is useful to utilize a standard format. One such format involves the following steps, in order: (1) ask the medic how they feel about their performance, (2) tell them what they did right, (3) tell them what they did wrong citing specific objectives and examples, (4) reiterate how the objective should have been performed and, finally, (5) briefly summarize the performance and reinforce what they did well.²

This process of evaluation is most detailed when the FTO is “clearing” new employees for practice as part of the process by which the medical director credentials the medic. A modified version may also be used when rolling out new skills, medications, or clinical approaches.

HIGH-FIDELITY SIMULATION

A BRIEF HISTORY OF SIMULATION

For centuries, professors of medicine have been challenged with a dilemma: how can a student practice and gain the skills necessary to care for critically ill patients, while still giving patients safe and competent care? A wide variety of patient simulation devices have been employed to address this problem, including the use of cadavers, animal labs, static models of wood (and later, plastic) in an attempt to give students the feel of performing life-saving techniques without risking the lives of actual patients (Figure 7-3). It was not until the introduction of SimOne in 1968, followed by the Harvey cardiology trainer that same year, that the potential of mechanical patient simulators became widely acknowledged.³ Today, there are dozens of models designed to train professionals in a variety of procedures ranging from airway management to colonoscopy. Many of these models now feature important physical examination findings, such as pupils that react to light, pulses that bound and ebb, and heart and lung sounds that can suggest complex physiological changes. As these models evolve to better approximate critical illness and trauma, influential reports such as To Err is Human: A Call to a Safer Health System have increasingly called to incorporate simulation into all levels of medical training.⁴

The immediate safety of a trainee's patient is not the only benefit of a properly conceived and implemented simulation training program. Studies show improved knowledge and medical skills for the participants, high levels of satisfaction to both learners and instructors, and effective transfer of these skills into field practice. For example, students who learn basic CPR skills using HFS manikins are significantly more proficient at delivering appropriate chest compressions and ventilation than students who train using traditional manikins such as Resusci Anne.⁵ Nonetheless, great care must be taken in designing a simulation program if its full benefits are to be realized.

IMPLEMENTING A SUCCESSFUL HFS PROGRAM

Naturally, the first element of any HFS program involves access to a simulation laboratory. The details of creating and staffing such a lab are beyond the scope of this chapter; however, as noted above, most EMS training programs are associated with a community college or local university with an existing simulation laboratory; therefore, the specifics will vary depending upon the host institution.

Components of HFS Design 

One popular course framework (proposed by Jeffries) identifies five major components that contribute to a successful HFS program. Competent and supportive teachers, motivated and well-prepared students, and a well-defined set of demonstrable, objective criteria form three of the five components. In addition, a program should be designed using educational practices that create an active, collaborative learning environment characterized by high expectations on the part of the faculty, directed toward achievable and measurable objectives.⁶ In the section below we address the most complex component: design of the simulation experience.

SIMULATION DESIGN

The first critical action in implementing an HFS program is to develop a list of learning objectives. These should be measurable skills that the student should be able to demonstrate upon completion of the simulation exercises. Because simulator time is typically limited, simulation objectives should focus on the psychomotor skills and clinical problem-solving exercises that best exploit its use.

While simulation attempts to be lifelike (Figure 7-4), the experience is not usually natural to the student from the start. After measurable objectives are communicated, students should be introduced to each feature of the simulator, as well as the role of each piece of equipment in the room that they will be expected to use. Early simulation encounters should be simple, typically involving just one clinical problem or derangement. From the first encounter, all simulations should be made to be as “real” as possible, following a typical clinical course, in an environment that mimics a real-life scenario as closely as practical. As learners gain experience, the level of scenario complexity can be increased to include multiple medical problems, equipment challenges, and irrelevant or distracting data, to more closely approximate situations that providers encounter in the field. Lastly, all simulations should be followed by a debriefing session, where the student reviews her perceptions of the simulation, identifies performance strengths and weaknesses, and receives constructive feedback to be applied to future scenarios. This debriefing session should focus on developing the student's critical thinking skills, rather than fumbles or “misses,” with an aim to improve self-confidence and readiness to tackle field work.⁷

Finally, as departmental goals develop and change, so should simulation exercises. New techniques and equipment constantly pose new training challenges, even for veteran providers. Thus, students should come to see the simulation lab as a lifelong method of improving old skills and obtaining new ones, as a part of the EMS provider's relentless quest to deliver the finest possible care for living patients.

DISTANCE LEARNING

Throughout this chapter, we have paid attention to the considerable psychomotor skills that EMS providers must acquire, as well as the vast content area of practical knowledge that must be mastered in order to become a credentialed medic. Traditionally, this education has taken the form of classroom teaching in lecture format, using assignments to ensure appropriate progress and written tests to confirm mastery of key concepts. This is usually referred to as “traditional learning.” Alternatively, long-distance communication has been successfully used for many years as an adjunct to, and occasionally as a replacement for, traditional learning. In distance learning (DL), course materials are typically mailed (or, more recently, e-mailed) to the student, regular assignments are given, examinations are administered, and grades or certificates distributed, sometimes without the student and teacher ever physically meeting. With the advent of ubiquitous computers and the World Wide Web, the practice of instructing students over great distances has become an accepted and valuable mode of education in nearly all fields of study. EMS students may learn as well in DL as they do in traditional learning⁸; however, the medical director who wishes to incorporate DL into a department's educational plan should be aware that there are significant pitfalls to be avoided.

ADVANTAGES OF DISTANCE LEARNING

Students report that they are attracted to, and value, the enormous flexibility that DL offers. The ability to learn, study, and take examinations at virtually any time of day can be of critical importance to working trainees. Many students also find that they can pursue their studies at a pace that suits that individual's learning style. This greater freedom necessitates greater responsibility, and many students appreciate the opportunity to take charge of their own learning plan and gain valuable confidence from their own self-directed success.

DISADVANTAGES OF DISTANCE LEARNING

Unfortunately, the very factors that attract students to this learning format, such as a difficult working schedule or significant family demands, can impair the success of the program as well. A student can significantly underestimate the amount of time required for his or her assignments and fail to plan ahead for large projects and examinations. Another may overestimate his or her own self-discipline and fail to make steady progress without daily classroom structure. Certain students, despite the best of intentions, may require classroom interaction in order to make sure that appropriate learning takes place.

In addition, certain content does not adapt well to an electronic-only format. In particular, procedural knowledge (such as CPR, venous cannulation and intubation skill) is best taught one-on-one, under direct supervision with immediate feedback and correction. For these reasons, most EMS training programs are not suited to a DL-only format.

HYBRID MODEL

A hybrid model of DL uses a combination of traditional learning format with elements of DL, in order to capitalize on the most effective qualities of each model. Student groups form and interact more effectively in person than online, while at the same time the smaller number of physical meetings to attend allows students greater freedom to incorporate coursework into a busy work and family schedule. Nonetheless, great care must be taken to preserve these advantages when designing a hybrid course, in order to avoid some of the pitfalls noted above. Since procedural knowledge is key to EMS training, most EMS DL programs will, by necessity, be hybrid programs.

IMPLEMENTING A SUCCESSFUL DL PROGRAM

Technological Requirements 

The vast majority of contemporary DL programs take place using a World Wide Web–based platform; therefore, most DL requires that both the student and the instructor have reliable access to relatively modern computers at convenient times of day with up-to-date Web browsers installed and reliable access to the Internet. Most students meet these requirements at home; however, local libraries, community colleges, and Internet cafés can provide acceptable alternatives. In these cases, it must be stressed to the students that they are responsible for making sure that their access is reliable before undertaking the course.

Many commercial platforms are available for the instructor to organize and deliver both content and testing materials. Ideally, selection of a particular platform will depend upon the content to be delivered, types and frequency of assignments, and the desired method of evaluation. Alternatively, an ambitious instructor could design a course using nothing but a basic word-processing program and standard e-mail; however, between tallying assignments and maintaining testing rigor, administration tasks could quickly become onerous. Practical instructors usually opt for the platform currently in use at the department's affiliated community college. In this case, refer to that college's information systems department for specific computer and Internet requirements before undertaking a DL program.

SETTING STUDENT EXPECTATIONS

One underappreciated aspect of course implementation is the communication of expectations to students. Instructors should be explicit: readings should be finished on time, assignments will be marked down (or not accepted) after their due date, and all efforts are to be the original work of the student and no one else. Students should also be told the approximate number of hours per day (or week) that the course requires, including meetings, readings, assignments, and testing. Early and appropriate action should reinforce these standards if any expectation is not met.

EVALUATING LEARNING GOALS

The appropriate assessment of learning in the student is a complex and sometimes contentious topic; however, a few brief guidelines should be kept in mind. Assignments should probe for depth of knowledge in particular topics, while testing should assess breadth of knowledge across content areas. When designing a test, every test item or procedure should relate to a previously presented learning objective, and all important learning objectives should be represented at some point in testing. Test items should be clear, unambiguous questions regarding physiological knowledge, or clinical presentation. If a question seems “too easy,” move into more difficult content rather than rewriting the question to obscure its base content. Multiple choice questions better discriminate knowledge when there are at least four alternatives to choose from, and when all alternatives could be plausible to a novice. A good question can be recognized when a top student can answer it without looking at the alternatives. Finally, if more than half of the students cannot answer a test item, consider replacing it.

DISTANCE LEARNING AND CONTINUING EDUCATION

Distance learning can provide an effective method for established, motivated learners to maintain and broaden the skills and knowledge they need in order to continually improve the level of care they provide for patients. As in certification education, only those aspects that are easily taught and assessed on paper or the computer screen should be attempted via DL. Also, a medical director may find that once the goal of credentialing has been reached, students may not be as motivated to keep up with their educational commitments. Regular progress reports and coursework deadlines can help keep students on track when undertaking continuing education, and modest incentives may serve to help keep students abreast of new technology and training techniques.

CONTINUOUS QUALITY IMPROVEMENT

Lasting excellence in a training program is not simply a goal to be achieved and maintained, but rather an ongoing process of inquiry, adjustment, data collection, and revision. These four actions form the core process of “total quality management,” a business philosophy first developed in the 1950s by W. Edwards Deming, who went on to develop an influential set of management principles. These principles have been successfully adapted (as “continuous quality improvement”) to diverse industries, and have improved the performance of many EMS departments to date using the following key aspects⁹:

• Everyone is responsible for quality improvement. Each employee from the medical director to each responder should feel empowered to identify and address areas where training can be improved or made more efficient. Medical directors must exemplify this commitment by taking interest in any detail that can lead to better training.

• Impediments to quality are due solely to errors in the system, not the people. EMS providers are attracted to the field because they naturally want to learn how to help, and it should be the attitude of the departmental leadership that failures to meet training goals are not personal failures, but instead represent opportunities to uncover and correct systemic flaws. This philosophy shifts the approach from an adversarial relationship to a professional collaboration with the common goal of improving education and job performance.

• Sound data are essential to improvement. Appropriate tests and performance data should be collected with the intent of using that data to recognize and reinforce good performance as well as to identify potential areas of systemic improvement.

Many strategies can be employed in the pursuit of training excellence; however, an improvement plan should always include the following elements:

1. The development of a descriptive and inspirational vision statement.

2. Identification of key driving factors (sometimes called “critical indicators”).

3. The adoption of measurable, achievable objectives for the department.

4. Meticulous collection and analysis of relevant data.

Other strategies may include the use of trainee focus groups, which can help identify obstacles and provide leadership feedback, comparison to statewide benchmarks to ensure that goals are realistic and achievable, and trainee well-being programs to make sure that trainees remain connected to the core reasons that motivated them to become providers.¹⁰

In instituting all of the above, the core process of inquiry, adjustment, data collection, and revision (sometimes called PDCA, for “plan, do, check, act”) should organize continuous improvement. Through feedback from instructors and trainees as well as data analysis, leadership plans a change that is projected to have a measurable impact on a specific key driver, members of the department do their part to make the change, followed by checking of data to ensure that measurable change has occurred. If not, swift action is taken to correct whatever flaws in the process persist. Care must be taken not to allow the department to become solely “number driven,” however. Only when the focus remains upon delivering high-quality training can the process be relied upon to lead to new cycles of improvement and better performance.

REMEDIATION

It should be the goal of training and remediation to give every opportunity to the motivated student to reach his or her goals within the department. Thus, when a student fails to pass qualifying examinations, or when an FTO determines that a trainee has not mastered the skills necessary to deliver independent care, the student should be entered into a formal process to identify deficient areas and to help the student achieve mastery of the necessary knowledge or skills. This process is called “remediation,” and it should never be approached as a personal failure, but as an opportunity to strengthen the training program so that it can better serve its trainees.

IDENTIFYING REMEDIATION CANDIDATES

Most students who are candidates for remediation are aware that they are not achieving their learning goals long before their instructors realize that there is a problem, so it is important to create an atmosphere where students can feel free to come forward and ask for help. Many students will not feel comfortable admitting that their education plan is not working, however; therefore, each department should set and communicate benchmarks that students should pass in order to be maintained in the standard education plan. If these benchmarks are not met—usually minimum test scores or passing assessments on practical skills—then remediation begins.

GOALS OF REMEDIATION

Remediation should be seen as a collaborative effort to remove learning obstacles for the student so that educational goals can be met. In the end, the goal of remediation is to return the student to a strengthened and more robust training program with new tools and confidence.

IMPLEMENTING A SUCCESSFUL REMEDIATION PROGRAM

Setting Expectations 

As with any educational endeavor, the expectations of the student and department must be clearly communicated at the start of remediation. The student must be open to making changes and committed to giving his best effort to the course. The instructor must be willing to put extra time and resources into ensuring success for the student. The approach to remediation must always stress the “win-win” nature of training, with the ultimate goal of ensuring that all providers deliver outstanding patient care. The department must communicate faith that this can be achieved, and the student must believe that he or she can and will succeed, in order for remediation to work.

Remediation Strategies 

First, the instructor should inquire into the conditions of the student's learning environment, including the amount of time and conditions under which the student studies, materials used, attitudes toward the content material, and so on. Often, this discussion will reveal key obstacles of which the instructor was unaware, and many times simple adjustments can be prescribed to the student's schedule or study habits that can have a profound impact on performance.

There are as many remediation strategies as there are students; however, no program can be considered complete unless the student has access to the following:

• Private tutoring: This can come in the form of extra time with an instructor, help from a former graduate, or simply pairing the student with a successful classmate. Whatever the method, one-on-one tutoring has the highest chance of improving test and procedural performance over any other remediation strategy.

• Alternative materials: No single textbook works well for all students, and often a student can improve dramatically through presenting the material in a different way. Instructors should always have alternative materials on hand, and be willing to try new materials when a student does not seem to be responding to the standard text.

• Formative examinations: Giving remediation students examinations that do not count toward their personal benchmarks allows greater feedback in areas of concern and also reinforces which areas of knowledge are of most concern to the program.¹¹

MONITORING PROGRESS AND TERMINATING REMEDIATION

Of course, students in remediation require close monitoring; however, the instructor should not project an attitude of “how are you doing?,” but rather “how are we helping you?” There is always another book to try, or a different tutor who might help. Some students will only be made more uncomfortable with these offers, however, and the tactful medical director will know when to make more materials available and when to leave students to find their own path. In some cases, multiple adjustments must be made before an effective combination of strategies can be found.

Ultimately, an EMS department is responsible to its patients, and students must show that they have mastered the knowledge and skills necessary to appropriately care for those patients in order to proceed. Thus, remediation ends when a student has either reached appropriate benchmarks or exhausted all of the above strategies for improvement and cannot identify any further ones. Most students will recognize at this point that they will be unable to serve the department as they would like, at which point the student's future role in the department will have to be discussed.

CONCLUSION

In addition to the myriad clinical oversight and practice responsibilities, the EMS medical director is essential in all phases of EMS education. This involvement begins with the planning and development of the initial education program, its operations and ongoing evaluation, as well as the specific evaluation of students both in the classroom, lab and in the field. A solid understanding of the education and regulatory foundation for this education is essential. Additionally, as the technology of simulations and DL continues to advance, so too will the opportunities for the medical director to leverage these tools to meet their responsibilities of ensuring a well-educated, well-trained, and appropriately credentialed EMS provider.

KEY POINTS

• All levels of prehospital provider education should be based on the National EMS Core Content as described in the National EMS Education Standards, peer-developed, and reviewed documents published by the National Highway Traffic Safety Administration (NHTSA).

• Educational programs each develop their own curricula and may seek accreditation sponsored by the Committee on Accreditation of Educational Programs for the EMS Professions (CoAEMSP).

• Prior to practice, providers must achieve certification by successfully completing the national examination developed and administered by the National Registry of EMTs (NREMT), and/or apply to be licensed by their state EMS office and finally successfully complete the local process defined by their EMS medical director in order to be credentialed to practice.

• The most common levels of EMS provider, being standardized nationally, are the emergency medical responder (EMR), emergency medical technician (EMT), advanced emergency medical technician (AEMT), and paramedic.

• Providers receive their initial education through a variety of institutions including EMS and fire departments, educational consortiums, and, most commonly, community colleges and universities.

• The NREMT will require candidates for paramedic certification to have graduated from a nationally accredited paramedic program beginning January 1, 2013.

• The field training officer (FTO) is responsible, under the supervision of the EMS medical director, for providing education and evaluation of providers during initial and ongoing training using written objectives that are specific, measurable, attainable, and tied to desired job-related competencies.

• Simulation training must be based on well communicated and measurable objectives in as realistic a setting as possible and should be followed by debriefing session in which specific, objective, and actionable feedback is provided immediately to the learner.

• Distance learning technologies are advancing rapidly, however, may require greater self-discipline from the learner and greater preparation time for the instructor.

• A remediation program should be available at all levels of provider education, be flexible and based on the individual learner's needs, and may include private tutoring, peer assistance, alternative source materials, and formative or “practice” examinations.

REFERENCES

INTRODUCTION

An emergency medical services (EMS) agency medical director usually focuses primarily on the oversight of the care provided directly to patients and their families. One of the medical director's other main concerns is that of the health and safety of the EMS providers. These concerns overlap in a number of ways. This chapter specifically deals with diversion issues and identifying and managing potentially impaired providers. The more an EMS physician knows about diversion of narcotics and other substances, the more likely they are to be able to properly oversee the EMS agency–controlled substance program and to help safeguard the health and safety of patients and EMS providers alike.

OBJECTIVES

• Describe the components of an EMS agency narcotics control program.

• Describe the process by which EMS agencies obtain, stock, and utilize controlled substances.

• Discuss DEA regulations and the differences between using a personal DEA registration versus an agency DEA registration.

• Discuss state narcotics laws and regulations that affect EMS agencies.

• Describe proper storage and handling of controlled substances.

• Discuss wasting and accountability for controlled substances.

• Discuss diversion of controlled substances by providers, how surveillance may prevent and/or identify a problem, and what to do when a diversion issue has been identified.

• Discuss risk factors and warning signals associated with a provider who is impaired by drugs and/or alcohol use/abuse.

EMS AGENCY NARCOTICS CONTROL PROGRAM

Diversion means different things to different people. In its strictest sense, diversion means to move attention away from themselves through ­finger pointing, nit picking, manipulation, sleight of hand, or misdirection. For law enforcement purposes, diversion means the misappropriation of DEA scheduled medications from approved and/or legitimate patient usage, through doctor shopping, prescription forgery, theft, or substitution. Those who divert drugs often utilize skills mentioned in the above definition. EMS providers are not immune to diversion and agencies and medical directors need to be vigilant to ensure that such is not occurring in their systems. Drug addiction is an occupational hazard among EMS professionals, who have easy access to controlled substances such as Fentanyl, Morphine, Demerol, Versed, and other highly addicted drugs. Tampering is the diversion of medications done in such a way that it looks like drugs were never stolen. The tampered medication is then left in the system, to be used by an unsuspecting health care professional. EMS provider reports of patients not experiencing pain relief after the administration of pain medication may be a red flag indicating drug tampering.

Structured programs should be in place to account for and stocking, use, and restocking of controlled medications. EMS professionals cannot consistently divert drugs if the system has adequate physical security and an effective record-keeping system with a comprehensive audit trail. Most EMS health care professionals are unaware of the magnitude of the legal hazard associated with failing to provide adequate security and maintaining complete and accurate controlled substance records. EMS agencies should have a narcotics control program and written policies covering the acquisition, storage, and use of controlled substances. Elements of this program should include ordering and stocking of drugs, controlled access storage, crew shift counts and checklists, quality improvement programs that monitor use of drugs on specific patients, and medical director sign off on drug counts. Box 8-1 further describes elements that should be incorporated into an agency-controlled substance program. Box 8-1 Elements of an Agency-Controlled Substance Program

• Each vial has unique tracking number.

• Providers assigned specific numbered narcotic pouches.

• Providers required to fill out narcotic resupply forms when using narcotics.

• Resupply occurs only after patient care reports and narcotic resupply forms match.

• Weekly reports are made of providers' controlled substance administrations.

• Medical director sign off at least weekly on reports.

• Scheduled and random controlled substance audits are conducted.

• Random provider drug testing conducted as well as ability to conduct testing “for cause” if concerns arise.

Agencies should also have wellness programs, which are a ­systematic approach for professionals to get assistance in overcoming alcohol or drug addiction. When identified, these individuals enter into a contract where they maintain sobriety to maintain their employment. Model systems use medical models and inpatient services (when needed) for the initial stages followed by regular counseling and continual drug and alcohol screening.

DEA REGULATIONS AND AUTHORITY

The Federal Drug Enforcement Agency (DEA) regulations cover narcotic dispensing and use. All physicians prescribing narcotics are required to maintain a separate license for dispensing narcotics that must be periodically renewed. Historically, many medical directors have used their own DEA license, either directly or through hospital pharmacies, to order controlled substances for their EMS agencies. Presently, this practice is discouraged and has all but disappeared in some areas due to lack of accountability, diversion issues, and increased DEA scrutiny. Obtaining separate physician DEA licenses for each EMS agency for which a physician is providing medical direction is being recommended and even required in some states. The DEA requires absolute accountability by an EMS agency that uses controlled substances during patient care. Areas of accountability are specified clearly in DEA regulations (Box 8-2).¹ Box 8-2 DEA-Required Areas of Drug Accountability

• Ordering and receipt of medications in a manner compliant with DEA regulations

• Proper completion and signature on the third copy of the DEA-222 forms

• Controlled, proper distribution of medications within the agency

• Documentation of all usage and wastage

• Resupply based only on documented usage

• Auditing procedures that use both routine and random inspections

• Investigative procedures in place in the event of incorrect audits

The EMS agency must keep records compliant with all DEA requirements. The DEA has the authority to schedule inspections and audits at any time of controlled substance usage by any “entity” that maintains inventory of these substances, including EMS. EMS agencies should educate all employees that each has a responsibility to report drug diversion according to the Code of Federal Regulations, Section 1301.91. The DEA's stance is an employee who has knowledge of drug diversion by a fellow employee is obligated to report such information to a responsible official of the agency. The agency should treat this information as confidential and take all reasonable steps to protect the confidentiality of the information and identity of the employee furnishing it. The DEA considers failure by an employee to report diversion to directly impact the ability of continuing to allow that employee to work in a drug secured area. Furthermore, the DEA believes employers have a responsibility to inform their employees accordingly of the requirements of the code. All agencies should ensure the above has occurred. Individuals found tampering with or diverting narcotics is charged under the Federal Anti-tampering Act which carries maximum penalties of $25,000 and 10 years in prison. If a death results from these actions the maximum penalty is $100,000 and life imprisonment.

Many of the narcotics, depressants, and stimulants manufactured for legitimate medical use are subject to abuse and have, therefore, been brought under legal control. Under federal law, all businesses that import, export, manufacture, or distribute controlled substances; all health professionals licensed to dispense, administer, or prescribe them; and all pharmacies authorized to fill prescriptions must register with the DEA. Registrants must comply with regulatory requirements relating to drug security and record keeping. The DEA is also obligated under international treaties to monitor the movement of controlled substances across US borders and to issue import and export permits for such.

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs (21 CFR). Individuals having knowledge of drug diversion are obliged to report such knowledge to law enforcement and the DEA through 21 CFR. Specific items that must be reported to the DEA as specified in 21 CFR are noted in Box 8-3. The Office of Diversion Control is the component of the DEA which investigates and ensures that the regulations are followed. Diversion investigations can involve physicians who sell prescriptions to drug dealers or abusers; pharmacists who falsify records and sell drugs; employees who steal from inventory or falsify records to cover illicit diversion; prescription forgers; and individuals who commit armed robbery of pharmacies. The DEA considers the theft of controlled substances from a registrant to be a criminal act, and a source of controlled substances diversion requiring notification of DEA (FR Doc 03-17127). The DEA registrant is required to notify the area DEA field office immediately upon discovery of any theft of controlled substances. If the circumstances are known, online DEA form 106 should be filed. When an investigation is needed to determine circumstances, initial notice to the DEA may be done by faxed statement and form 106 submitted after the investigation is completed. Local law enforcement should also be notified, and this may be mandatory in some states. If the medical director is the DEA registrant, this responsibility falls to them. However, if the DEA license belongs to the EMS agency it becomes their responsibility to ensure that law enforcement is properly notified and DEA forms filed. Box 8-3 Reports Required by 21 CFR^*

• Destruction of controlled substances

• Import/export declarations (chemical reports)

• Import/export permit applications and declarations (controlled substances)

• Quota applications and year-end reports

• Theft or loss of controlled substances

STATE LAWS AND REGULATIONS

All states have EMS and pharmacy regulations governing the dispensing of narcotic and controlled substances. Compliance with these is overseen by state departments of EMS and pharmacy boards. Pharmacy boards license pharmacists, pharmacies and oversee the distribution of drugs within the state. There are also national organizations dedicated to drug monitoring. The National Association of State Controlled Substance Authorities (www.nascsa.org) is a 501(C)³ nonprofit educational organization whose primary purpose is to provide a mechanism through which state and federal agencies and others can work to increase effectiveness and efficiency of state and national efforts to prevent and control drug diversion and abuse. NASCSA works cooperatively with the DEA, US Food and Drug Administration, Substance Abuse and Mental Health Services Administration, National Institute on Drug Abuse, National Alliance for Model State Drug Laws, state professional licensing boards, pharmaceutical companies, and other national associations. NASCA also sponsors another organization, Alliance of States With Prescription Monitoring Programs (http://www.nascsa.org/rxMonitoring.htm), to facilitate exchange of information across states with prescription monitoring programs. Both the state pharmacy and EMS agencies will conduct monitoring programs for compliance with regulations. These often include periodic on-site inspections of drug storage and records.

State regulations contain explicit instructions as to agency responsibilities in monitoring and dispensing of controlled substances as well as actions to take when loss or diversion is suspected. Failure to comply may lead to loss of licensure or certification of the pharmacy or agency involved. Medical directors should be knowledgeable of the regulations governing controlled substance storage and usage in their states. Administration of drugs by EMS personnel is limited to their scope of practice, as determined by the state office of EMS, the individual's certification level, and the protocols established by the medical director. State regulations also allow drug administration when the EMS provider is acting within their certification level under a direct prescriber's orders received over an active communication link (ie, online medical command).

HANDLING OF CONTROLLED SUBSTANCES

EMS agencies obtain controlled substances either through direct ­ordering or a hospital exchange program. Many hospitals have a program whereby EMS can do a one-to-one exchange of medications either in the emergency department or pharmacy itself. This often takes the form of obtaining medications through a pyxis device, limiting access to approved personnel. If hospital exchange programs are utilized there generally is also an administrative cost, particularly if the EMS agency bills for service, as federal anti-kickback laws come into play if the hospital provides this service for free.

If EMS agencies choose to pack their own drug boxes rather than ­hospital exchange of boxes, there are increased responsibilities. EMS agencies must comply with federal and state regulations concerning storage of controlled substances. General security requirements are listed in the Code of Federal Regulations—Title 21 CFR Sections 1301.72-1301.76. Key components of these requirements for schedule II drugs (narcotics) are they must be stored in a safe, steel cabinet or secured room/vault that must be locked at all times when not in use. The safe or cabinet must meet specifications that include 10 man-minutes against forced entry and 20 man-hours against lock manipulation. If the safe or cabinet weighs less than 750 pounds it must be bolted or cemented to the floor. Secure room/vault specifications are also listed. Depending on the quantities and types of controlled substances stored an alarm system may be required. Entry into the safe, cabinet, or secured room/vault should be limited to a limited number of supervising staff. Ideally the secured area should keep a log of who enters at all times. Inventories should be done at least daily, and ideally at each change of shift. Inventory and administration records of controlled substances should be maintained separately from all other records and kept in chronological order. Records of receipt of drugs must also be kept including date of receipt, name and address of person who received, and kind and quantity of drug.

Regardless of how the drugs are obtained, overall supervision and control of these drugs are the responsibility of EMS organization personnel who hold appropriate certification to access the drugs for which they are responsible. All drugs must be secured in a tamper-evident setting with access limited to EMS personnel based on their certification status. All licensed entities that can possess controlled substances are mandated to provide effective controls and procedures to deter and detect theft and drug diversion.

PROPER STORAGE

EMS agencies should have written accountability practices. Controlled substances should be inventoried and recorded at the change of each shift. Both the off-going and on-coming staff members should sign the inventory records, which should be kept for a minimum of 2 years. Discrepancies are most often caused by someone forgetting to sign out a drug for restocking, and should be swiftly corrected when discovered. All shift paperwork must be reviewed until the missing controlled substance documentation is found. It is also helpful to have shift supervisors review inventory sheets frequently and at least on a weekly basis to ensure that compliance is occurring. As stated previously, the DEA registrant is ultimately held responsible for the security and proper use of the controlled substance. As such, the medical director has ultimate responsibility and should periodically review these logs for compliance also. It is suggested that at a minimum this should be done weekly. In some states, physician signature on these logs is actually required by the pharmacy board.

Individual stocked drug boxes should be kept in secured locked compartments within ambulances. If the agency restocks its own drug boxes, those kept at agency headquarters should also be locked in a special area as noted previously at all times. This area should be restricted to only a few personnel who are responsible for dispensing new boxes and inventory of the returned used drug boxes. Best practices would dictate that when a box is returned, both the provider exchanging the box and the supervisor dispensing a new box sign the log and verify the returned drug box contents. Drug inventories should be performed by each EMS agency on a routine basis, tracking drug box expiration dates and ensuring that they are exchanged or used before expiration dates. A rotational system should be developed to place older boxes in service before they expire and replace stock with newly exchanged boxes. Medications and drug boxes should be kept in locked ambulances at all times or removed from vehicles and stored in a properly maintained and locked secure environment if that is not possible.

Drug boxes are to be sealed at all times. EMS agencies should have policies and procedures detailing what providers should do if this is compromised. If accidentally broken or opened and not used, the drug box should be immediately returned for restocking. If a provider finds a box with a broken seal, the contents should be inspected and if missing drugs are found or appear to have been tampered with, the provider should avoid handling the box and notify law enforcement. The box should be returned to the pharmacy where box was packed, or if stocked by the agency, returned to a supervisor so it can be secured until further processing can occur. A drug diversion form should be completed according to state regulations. Many states have regulations requiring EMS agencies to notify the state office of EMS for any suspected diversion, loss, theft, or tampering of controlled substances, medication delivery devices, or other regulated materials from an agency, facility, or vehicle. It behooves the medical director to familiarize themselves with their agencies' policies and to ensure compliance with regulations.

Sealed drug boxes, either from the pharmacy or the agency itself if it does its own restocking, can also be a source of discrepancies. Occasionally, a field provider may open a drug box and find certain medications or supplies missing from the box. There should be a drug box incident reporting form available (preferably placed in each sealed box) for the provider to document what was missing upon opening the box so that an investigation can ensue to determine what occurred. EMS providers should be instructed to check for the presence of all controlled substances every time they open a drug box. If there are missing controlled substances discovered upon opening the box it is most likely a restocking error. This should be easily detected retrospectively with a review of the records. If the missing controlled substances are not discovered until the box is returned to for exchange, there are more possibilities to consider including diversion which likely will result in increased scrutiny and stress for the provider. The medical director should be cognizant of these occurrences to ensure a pattern does not arise with specific providers. This can be done by asking the agency to provide a copy of any incident report generated as a result of missing controlled substances during restocking, or working collaboratively with the pharmacy involved to alert you of occurrences.

WASTING AND ACCOUNTABILITY

Success of any accountability system is based on the full understanding and support by EMS providers, hospital pharmacies, medical directors, and emergency department physicians. It is common for EMS providers to have small amounts of unused portions of controlled substances left at the end of a call. The most common practice is for the unused portion to be drawn up out of the vial/ampoule and wasted in the presence of a ­witness. Partially used controlled medications should not be administered to any other patient other than the individual the medication was opened for. The remainder should be disposed of immediately following completion of the transport, and disposal witnessed by an EMS crew member, registered nurse, or pharmacist. Some systems specify who the witness should be, such as an ED nurse. The EMS provider and witness document the waste on the run sheet along with their signatures. Both the amount in milligrams given to the patient and the amount wasted should both be documented on the same record (eg, morphine 6 mg given, 4 mg wasted). Unused portions of controlled substances should never be passed on to other agencies (such as flight programs the agency might have turned the patient over to) or returned to an open drug box. Instead unused portions should be wasted by the provider who opened the vial.

Some systems use reverse distribution where all narcotic containers are returned to headquarters for wasting instead of wasting any unused medication immediately after use. This return allows for random analysis of the medications to ensure that diversion and replacement with substances other than the appropriate narcotic have occurred. When this system is used, all parts of the narcotic container should be returned, especially the lids from vials and the wrappers that held the Carpujects. Benefits to this type of system are that any evidence is retained, rather than discarded, and personnel know that all returned stock or a fraction thereof will be analyzed. This accountability system is quite effective. Fear of getting caught causes addicts to tamper with narcotics rather than outright steal them. Fear of having returned narcotics through reverse distribution programs coming back as saline after analysis has prevented any further cases of diversion in systems that had such difficulties in the past.

The type of controlled substance storage system will depend on the narcotic exchange program used by the EMS agency. Some systems use drug boxes packed in hospital pharmacies. These boxes are generally sealed with a numbered plastic lock by a pharmacist and have a unique identifying number written on the box. The drug boxes are then stored in locked compartments on EMS vehicles. The storage compartment should be temperature controlled. After use, the EMS provider returns the opened drug box with documentation of what was administered and wasted to the pharmacy exchanging it for another sealed box. The pharmacy staff verifies that all controlled substances have been accounted for. Records are kept by the pharmacy of the identifying number on the box, the seal number, agency name, and name of the provider exchanging the box. A similar system should be in place at EMS agency headquarters, if the agency stores and stocks its own drug boxes. Disposal of large amounts of outdated controlled substances must be done in accordance with CFR. The code states that a controlled substance can be returned to a manufacturer who accepts returns, the registrant (DEA license holder) can dispose of the controlled substance under the procedures outlined in 21 CFR 1307.21, or the controlled substance can be turned over to the registered reverse distributor.²

DIVERSION OF CONTROLLED SUBSTANCES

The Code of Federal Drug Regulation in Section 1301.91 delineates employee responsibility to report drug diversion. Reports of drug diversion by fellow employees are not only a necessary part of an overall employee security program but also serve the public interest at large. Therefore, it is the position of DEA that an employee, who has knowledge of drug diversion by a fellow employee, has an obligation to report such information to the designated official of the employer. The employer shall treat such information as confidential and take all reasonable steps to protect the confidentiality of the information and identity of the employee furnishing the information. Failure to report information or knowledge of drug diversion can result in the employee not being allowed to work in a drug-secure area. The employer (EMS agency) should inform all employees of this code and policy.

Diversion of controlled substances can occur in many creative ways limited only by the creativity of the involved individuals. There are numerous and probably still to be discovered ways for providers to divert controlled substances. The most common involves replacing the controlled substance with another fluid, hopefully sterile saline. Of all the types of narcotic diversion, tampering with or substituting saline for the narcotic is nearly the most insidious, while also inhumane and selfish as the tampered container is left in the system to be used by an unsuspecting paramedic on an unsuspecting patient. Seemingly tamper proof packaging has proven not to be, as providers develop creative ways of altering packaging. (Figure 8-1). Another common ruse is “lost” or “broken” vials. As a certain amount of this occurs in normal operations, it takes vigilance to determine diversion utilizing this method. An anti-theft design by some manufacturers is to use plastic caps that spin before the seal is broken and the cap removed. If a vial cap is removed and glued back on, the cap will not spin, making tampering more noticeable. To circumvent this anti-theft design providers use very small gauge needles to puncture through the plastic cap and rubber stopper and remove the controlled substance. These minute punctures are very difficult to detect, and can only been viewed with a magnifying glass.³

Controlled substances can be stolen out of drug boxes. Some drug boxes are similar to fishing tackle boxes with front and side latches. The pharmacy or agency will place plastic seals on the front latch area, but this can be circumvented by removing the top part of the front latch, allowing the front flap to be opened without disturbing the plastic seal. To prevent this, the plastic seal can be placed through drilled holes in the front flap and top cover of the drug box. In addition, plastic seals can be numbered by the pharmacy or agency when dispensed to ensure that a seal is not discarded and replaced with another before returning the box for restocking. It is extremely rare for a provider to need to waste more than one or an entire vial or ampoule of a controlled substance. If this occurs, extra vigilance is appropriate. Provider explanations of these occurrences include that the medication was drawn up and not given it to the patient or the vial/ampoule was broken or missing when the drug box was opened. Providers who are noted to be wasting or missing multiple units of controlled substances should be counseled, and their controlled substance documentation audited.

Narcotic diversion is insidious, and it is difficult to recognize providers at risk for diversion. There are few common denominators and all levels of providers are involved. The one common denominator is access. Those that divert narcotics often have nearly unconstrained access to the drugs or know how to get access. Effective narcotic control and accountability systems are built to prevent field personnel from having direct physical access to narcotics except for times needed to treat a patient. Otherwise, they are stored inside a tamper-evident lock box. One must remember that access is still available to a supervisor, who is also not immune or above involvement in diversion. Multiple checks and balances should be built into the system to ensure that multiple eyes are on the box count should diversion occur. Narcotics restock programs where medications are stored in a locked area where a single person can access them at any time is a system asking for trouble. A far more secure and better approach would be to have narcotic cabinets utilize two keys: one key for the supervisor or administration and another key for field personnel. An electronic lock that requires two separate combinations, codes, or electronic key card can also be a deterrent and can track those who enter. No supervisor or single person, for their own sake, should ever have unrestricted access to narcotics stock. While the vast majority of EMS personnel are ethical people, unfortunately some are susceptible to temptation.

EFFECTIVE SURVEILLANCE PROGRAMS

An effective surveillance program can help prevent or identify drug diversions if they occur. Radio-frequency identification (RFID) tags can be placed on controlled substances which track location of vials and deter theft, but this can be cost prohibitive. Some form of nonremovable ID tags placed on every container can be helpful and less costly. A commercial shrink wrap machine can be used to secure items. The entire drug box can be closed with tamper evident tape with unique serial numbers. Some systems have used shrink wrap to enclose narcotics vials after placing a metal slug over the cap to prevent needles from being used to withdraw content illicitly. Pharmacy sealed containers can provide accountability if one-to-one exchange of medications occur directly after use, and the exchange is accompanied by a patient report sheet detailing the use of the drugs being restocked.

Some containers are more tamper proof than others. Certain glass ampoules are tamper proof, but have been known to cause provider injury and necessitate the use of filter needles. Agencies who self-stock should develop special secured drug lockers to secure medications before deployment to individual provider units as mentioned previously. It is recommended that the area be key secured and that only two providers have access. These providers would preferably be at the supervisor level. Two are preferred over single access as each can serve as a check on the other. Daily inventories should be conducted and a signed log kept to identify problems should they occur.

An effective quality improvement program is necessary for proper surveillance and heightened awareness to prevent diversion. Audits of run sheets benched against narcotic use should be routine part of the quality improvement program. EMS agencies should educate providers to verify that the medication they give works. If the patient states they are not getting relief from the narcotic, they should question why. Quite often, the first things that come to mind are that the patient is a drug seeker, has low tolerance for pain, or that not all people get relief from narcotics. Sadly we do not tend to keep track of these occurrences as well as we track our resuscitative efforts. If we tracked relief or improvement of pain in those patients whom we administer narcotics, it may trigger problems and the narcotics need to be analyzed for efficacy, environmental damage, and tampering if there is a pattern of no or little relief with pain medication administration. These occurrences should also be tracked for patterns relative to specific providers.

IMPAIRED PROVIDERS

As previously stated health care workers are as likely as anyone else to abuse drugs and are unfortunately involved in controlled substances diversion. With easy access to controlled substance medications available, some will divert and abuse these drugs for relief from stress, self-medication, or to improve work performance and alertness. Drug abusers often exhibit similar behaviors, and certain signs may indicate a drug addiction problem in a health care professional (Box 8-4).^4,5 Box 8-4 Warning Signs of Impaired Providers

• Chronic tardiness or work absenteeism without notice

• Degradation of performance due to poor decisions, inattention, or bad judgment

• Increasing personal and professional isolation

• Deterioration or lack of personal hygiene

• Increased irritability, mood swings

• Personality changes, anxiety, or depression

• Relationship breakup

• Heavy “wastage” of drugs

• Insistence on personal administration of injected narcotics to patients

• Excessive amounts of time near drug supply

• Volunteer for overtime and are at work when not schedule to be there

• Wearing long sleeves when not appropriate

• Frequent disappearances or long unexplained absences at work, trips to bathroom or stockroom

• Poor record keeping, suspect ledger entries and drug shortages

There is a natural reluctance to approach a coworker suspected of drug addiction. Many tend to assume they are overreacting and misinterpreting behaviors. There are fears that speaking out might anger the coworker, result in retribution, or result in termination of the suspected individual. Many employers or coworkers simply end up being “enablers” of health care practitioners as a result. Drug impaired coworkers are frequently protected from the consequences of their behavior. Addicted colleagues are often given lighter work schedules, switched among partners, or excuses made for their poor job performance. Excessive absences from the work site are often overlooked in long time employees who had previously demonstrated good work ethic. Unfortunately, this allows them to continue to rationalize their addictive behavior or continue denial that a problem exists. In addition, there are mandated federal laws regarding reporting that should be followed (see “DEA Regulations and Authority” section earlier in the chapter) with real consequences to the agency and individual if not followed.

If signs or symptoms of impairment are recognized in a provider, it is time to demonstrate concern. Drug abuse and drug dealing are serious problems that should be handled by qualified professionals. If it is suspected that an addiction problem exists or diversion is occurring, employees should be encouraged to not intervene on their own and report concerns to their supervisors. As noted in CFR 21, all efforts must be made to protect the identity of the information source if at all possible. Some states have mandatory reporting laws when a health care worker is found to be impaired secondary to drug use. However, most allow for return to work after successful completion of a remediation program with ongoing checks after return to work.

Confrontation techniques for those suspected of impairment start with an expression of concern. This should ideally come from an individual the suspected party respects and is likely to listen to. The denial that often comes with impairment may limit the effectiveness of this approach. Resistance can lead to the next step which is an intervention. This is a formal group process whereby the individual meets with a group of individuals who “confront” the individual in a supportive fashion while insisting that he get help. This step should not be undertaken lightly nor before resources are identified and available to help the provider. A ­member of this group should include a close friend who can offer support and act as an independent supportive voice for the individual. When confrontation occurs, the group should be ready to intervene immediately by getting the provider into a program to receive necessary help. Immediately after confrontation is the most dangerous time for an impaired provider, who may feel they have nothing to lose and possibly resort to self-harm. See Box 8-5 for effective confrontation recommendations.⁶ For some, the mere fact that a supervisor talks to them is enough to help them change. For others the problem may be more severe and require drastic ­measures such as the threat of termination. The threat of losing a job may have more influence on a drug abuser than a spouse's threat to leave or a friend's decision to end a relationship. Many drug abusers will seek help for their problem if they believe their job is at stake, even though they have ignored such pleas from other people important in their life.⁷ Box 8-5 Recommendations for Successful Interventions

• The intervention should be conducted by a team, not an individual.

• The team leader should be experienced in interventions.

• Team members should be educated about interventions and treatment possibilities.

• It is important to collect and evaluate as much data as possible prior to the intervention.

• Presentations during the intervention process should be focused on facts.

• The team should include only members whose attitude is conducive to the objective tone of the intervention.

Prior to speaking with an employee suspected of impairment, one should consult with the human resources department regarding applicable policies and procedures. In some settings, immediate drug screening can be mandated for cause. In situations where the employee is a member of a union, there may be a policy that the member has the right to have a union advocate with him during any discussions. He may also have the right to refuse drug screening until such time as a hearing occurs. Violation of processes and policies on the part of a supervisor may leave the agency open to legal redress or personal charges of slander. Therefore, it behooves agency leadership to familiarize themselves with such policies and to contact human resources in every case before any action, including verbal discussions with the employee, is taken.

Drug addicts can recover with appropriate intervention and help. There are effective programs available. Treatment programs range from guided self-help to formal inhospital recovery programs. A number of state licensing boards, employee assistance programs, state diversion programs, and peer assistance organizations are available to individuals and their families for appropriate counseling and treatment services. These services maintain the confidentiality of those seeking assistance to the greatest extent possible. EMS services and medical directors should be familiar with services that exist in their state.⁸

KEY POINTS

• Title 21 of the Code of Federal Regulations governs food and drugs.

• Title 21 CFR Section 1309.91 defines employee responsibility to report diversion of controlled substances.

• Title 21 CFR Sections 1301.72-76 define general security measures with regard to controlled substances.

• Tampering with or diverting a controlled substance incurs a fine of $25,000 and/or 10 years in prison.

• A death resulting from tampering or diversion of a controlled substance incurs a life prison sentence and $100,000 fine.

REFERENCES

INTRODUCTION

Public health as defined by Charles-Edward A. Winslow is “the science and art of preventing disease, prolonging life, and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities, and individuals.”¹The World Health Organization (WHO) defines the whole of public health as “a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”² Public health's charge is to protect the health of the population, which can range in size from a small group of people to several continents. Overall, public health strives to prevent illness and injury by protecting individuals from things they cannot directly control (eg, drinking contaminated water, inhaling tuberculosis bacteria) and promoting healthy behaviors for things they can directly control (eg, eating healthily, exercising regularly, not smoking).

Public health utilizes the elements of epidemiology, surveillance, and prevention. Epidemiology is the study of the distribution and determinants of health-related states or events in specified populations, and the application of this study to control health problems.³Epidemiological investigations are conducted to determine the distribution and determinants of disease and to attempt to categorize disease by person, place, and time.

Surveillance is the ongoing process of collecting, analyzing, and interpreting health data, and disseminating the conclusions to relevant entities. There are several types of surveillance utilized in routine public health practice including passive, active, sentinel, and syndromic. Passive surveillance is frequently utilized at the local and state levels in the form of case reporting. Depending on the locale, there may be well over 50 communicable diseases that must be reported to public health officials when diagnosed or suspected by physicians, laboratories, hospitals, and others. This differs from active surveillance in which public health agencies attempt to proactively identify individuals meeting specific criteria. Finding sexual partners of an individual with HIV or another confirmed sexually transmitted disease would be an example.⁴

Primary prevention, one of the most common public health strategies, includes actions to stop disease from occurring. Examples of primary prevention are childhood immunizations, hand washing, and seat belt use. Secondary prevention involves screening asymptomatic individuals to detect disease in the early stage and thereby preventing clinical manifestations. Examples of secondary prevention include blood pressure screening to detect hypertension, mammography to detect breast cancer, colonoscopy to detect colon cancer, and urine screening in adolescent girls to detect occult sexually transmitted diseases like chlamydia. Tertiary prevention is treatment of clinically manifested disease to halt the progression and complications of the disease.

OBJECTIVES

• Display a general understanding of the history, principles, and core disciplines of public health.

• Discuss the differences between governmental public health departments and the public health system.

• Understand primary, secondary, and tertiary prevention and how they relate to public health and EMS.

• Understand many of the commonalities, synergies, and partnerships, as well as some of the differences between EMS and public health.

• Understand the benefits from partnerships between EMS and public health.

HISTORY OF PUBLIC HEALTH

Public health concepts are evident from ancient times and developed out of necessity as primitive civilizations began to establish cities. Municipal water supplies and sewage systems have been documented by archeologists from ancient cities in Africa, Asia, Europe, and South America. Ancient sanitary engineering peaked in Rome where aqueducts supplied the city with water as effectively as modern water systems do today.

The practice of isolation (separating those with a communicable disease from those without) was practiced in early medieval times. Special rules created separate housing to exclude lepers from communities.

The Renaissance marked the beginning of a period of cultural growth and was also the beginning of a series of epidemics that devastated Europe and the Near East. This included the Black Death (bubonic plague), which killed 25% of the European population in 4 years. These events led to three important contributions to public health: the organization of boards of health, the promulgation of a theory of contagion, and the introduction of vital statistics (contagious disease and mortality data). ^5,6

Concepts emerged during the Enlightenment (1750 through mid-19th century) that encouraged government programs designed to protect the population against disease and to promote health. Theories of Utilitarianism (greatest good for the greatest number) led to legislation regarding prison reform, birth control, establishment of a ministry of health, and sanitary measures. Implementation of these ideas was championed by Edwin Chadwick in his publication General Report on the Sanitary Condition of the Labouring Population of Great Britain (1842). This report illustrated many population-based inequities and resulted in movement toward sewage systems, potable water supplies, refuse disposal, ventilation of housing and work locations, and supervision of public works by qualified individuals.

In 1854, a cholera outbreak in London resulted in a defining moment in epidemiology founded by physician John Snow. Snow was skeptical of the then current miasma theory, which postulated that diseases like cholera or plague were caused by breathing “bad air.” Snow's study of the pattern of cholera in London led to the removal of the Broad Street pump based on his conclusion that ingestion of water contaminated with fecal matter resulted in illness. In the 1870s and 1880s tremendous advances were made by French scientist Louis Pasteur and German physician Robert Koch. Together these two scientists are known as the fathers of the germ theory and bacteriology. Pasteur is best known for his recognition that fermentation is caused by growth of microorganisms and spoiling of beverages like beer, wine, and milk. The process of heating liquids to kill harmful bacteria was later termed pasteurization. Pasteur also developed vaccinations for rabies and anthrax. Koch furthered the support of the germ theory with his development of the Koch postulates that outline the characteristics an organism must have to cause disease. He is also famous for isolating several organisms including Bacillus anthracis, tuberculosis bacillus, and Vibrio cholerae. ^5,6

MODERN PUBLIC HEALTH

The improvements in sanitary conditions and development of bacteriology in the early 20th century reduced mortality from enteric diseases and shifted the focus of public health interventions to other problems. Development of maternal and child health programs to reduce infant mortality, government regulation of the food processing industry, industrial hygiene and occupational health programs to address occupational injury and disease, and focus on mental health and nutrition were among the highlights of this period.

A developmental process known as epidemiological transition occurs as a country undergoes modernization from Third World to First World. Population rates sharply increase and then level off due to declining fertility rates. Infectious disease rates decrease because of immunization and communicable disease control, and public health initiatives shift to chronic diseases like heart disease and cancer.⁶ In the second half of the 20th century, the role of public health expanded to address aging populations in industrialized nations, recognition of the importance of behavioral risk factors (eg, diet, tobacco use, obesity, high-risk sexual practices), increasing social inequalities in health, and violence.⁵ Box 9-1 10 Essential Functions of Public Health

1. Monitor health status to identify and solve community health problems.

2. Diagnose and investigate health problems and health hazards in the community.

3. Inform, educate, and empower people about health issues.

4. Mobilize community partnerships and action to identify and solve health problems.

5. Develop policies and plans that support individual and community health efforts.

6. Enforce laws and regulations that protect health and ensure safety.

7. Link people to needed personal health services and ensure the provision of health care when otherwise unavailable.

8. Ensure competent public and personal health care workforce.

9. Evaluate effectiveness, accessibility, and quality of personal and population-based health services.

10. Research for new insights and innovative solutions to health problems.

As we move into the 21st century, public health faces challenges such as naturally emerging infections like severe acute respiratory syndrome (SARS) and the H1N1 pandemic; bioterrorism by the intentional release of anthrax and diseases previously eradicated such as smallpox; health inequities and lack of access to affordable health care; childhood obesity; and long-term effects of natural disasters including the Indian Ocean tsunami (2004), Hurricane Katrina (2005), and the Haiti earthquake (2010).

The 1988 Institute of Medicine (IOM) report The Future of Public Health describes three core functions of public health that are necessary to maintain and improve the health of the community. These include assessment, policy development, and assurance. Assessment involves the ongoing collection of community health data, and the analysis of these findings to identify trends in illness, injury, and death. Priorities determined from assessment are used to develop local, state, and federal health policies, which must consider community, political, and social infrastructures for successful implementation. Assurance is making sure that all members of the population have access to appropriate and cost-effective health services including those for prevention and health promotion along with evaluation of the effectiveness of these efforts.⁷

The 1994 Vision of Public Health in America “Healthy People in Healthy Communities” outlined the goals of public health to prevent epidemics and the spread of disease, protect against environmental hazards, promote and encourage healthy behaviors and injury prevention, respond to disasters and assist communities in recovery, and ensure the quality and accessibility of health services.⁸ The 10 essential functions of public health (Box 9-1) are those public health services necessary to achieve these goals. Together, they provide a working definition of public health and a guiding framework for the responsibilities of public health systems. These essential services operationalize the core functions of public health. The relationship between the core functions and the essential services are illustrated in Figure 9-1.

TEN GREATEST PUBLIC HEALTH ACHIEVEMENTS

Although somewhat subjective, health scientists at the CDC nominated the most noteworthy public health achievements in the United States from 2001 to 2010. These include vaccine-preventable diseases, prevention and control of infectious diseases, tobacco control, maternal and infant health, motor vehicle safety, cardiovascular disease prevention, occupational safety, cancer prevention, childhood lead poisoning prevention, and public health preparedness and response. These advances in public health led to significant contributions in the decrease in the age-adjusted death rate from the leading causes of death in the United States.⁹

ORGANIZATION OF PUBLIC HEALTH AGENCIES

Effective delivery of services by public health organizations at the federal, state, tribal, and local levels requires a capable and qualified workforce, up-to-date data and information systems, and public health agencies capable of assessing and responding to public health needs.¹⁰ A strong public health infrastructure depends on effective coordination among all of these organizations.

INTERNATIONAL PUBLIC HEALTH

WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. WHO fulfills these objectives through its core functions that include providing leadership on matters critical to health and engaging in partnerships where joint action is needed; shaping the research agenda and stimulating the generation, translation, and dissemination of valuable knowledge; setting norms and standards and promoting and monitoring their implementation; articulating ethical and evidence-based policy options; providing technical support, catalyzing change, and building sustainable institutional capacity; and monitoring the health situation and assessing health trends.¹¹

FEDERAL HEALTH AGENCIES

Most US governmental health agencies fall under the Department of Health and Human Services (HHS). HHS is the principal department responsible for protecting the health of all Americans along with providing essential human services especially for those who are least able to help themselves. HHS comprises the Office of the Secretary (18 staff divisions) and 11 operating divisions including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Health Resources Services Administration (HRSA), and the National Institutes of Health (NIH).

The CDC is considered the national authority on public health. It promotes health and quality of life by preventing and controlling disease, injury, and disability. The CDC is composed of the Office of the Director, the National Institute for Occupational Safety and Health, the Center for Global Health, and five offices including Public Health Preparedness and Response; State and Local Support; Surveillance, Epidemiology and Laboratory Services; Non-communicable Diseases, Injury, and Environmental Health; and Infectious Diseases.¹²

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, cosmetics, products that emit radiation, and our nation's food supply. Ideally, this is accomplished while simultaneously helping speed innovations that make medicines and foods more effective, safer, and more affordable. In addition, the FDA ensures that the public receives accurate, science-based information on medicines and food to improve their health.¹³

The HRSA is the primary federal agency responsible for improving access to health care services especially for people who are uninsured, isolated, or medically vulnerable. The Indian Health Services (IHS) provides a comprehensive public health and health care delivery system for approximately 1.9 million American Indians and Alaska Natives who belong to 564 federally recognized tribes in 35 states.¹⁴

In addition to the agencies that fall under the HHS umbrella, there are several other agencies responsible for protecting specific aspects of the public's health. The Environmental Protection Agency (EPA) is tasked with protecting human health and the environment by writing and enforcing regulations based on laws passed by Congress. Since 1970, the EPA has been working for a cleaner, healthier environment for the American people. The Occupational Safety and Health Administration (OSHA) ensures the health and safety of America's workers by setting and enforcing standards; providing training, outreach, and education; establishing partnerships; and encouraging continual improvement in workplace health and safety. The mission of the National Highway Traffic Safety Administration or NHTSA is to save lives, prevent injuries, and reduce economic costs due to road traffic crashes through education, research, safety standards, and enforcement activity. It includes the office of EMS, which leads federal EMS efforts.

STATE HEALTH AGENCIES

The US Constitution delegates the main responsibility for protecting the public's health to the states that may, in turn, delegate authority to the local level. As a result, there are considerable differences in state approaches. At least half of the states report having a free-standing public health agency (state department of health), and the remainder include public health under a larger umbrella such as a department of human services.¹⁵ Although there is some variability in the functioning of state health departments, most distribute funds to local health departments and other agencies; maintain datasets of vital statistics (birth and death certificates); collect and report information on reportable communicable diseases; credential health care professionals; and oversee public health laboratories, rural health, special needs children, and minority health.¹⁶ In some states, the lead EMS agency is a division of the state health department.

LOCAL HEALTH DEPARTMENTS

As the level of authority moves to the local level, an even greater variability in governance, organizational structure, and roles and responsibilities exist. The National Association of City and County Health Officials (NACCHO) developed the National Profile of Local Health Departments (LHD) in 2008 to characterize the jurisdiction and governance of LHD.¹² Only a small percentage (5%) of the 2794 LHD in the United States serve populations larger than 500,000 persons, and the majority (64%) serve populations less than 50,000 persons. Most LHD (60%) are county based. An additional 11% serve combined city-county jurisdictions; 9% serve multicounties, districts, or regions; 7% serve cities; and 11% serve towns. The services provided at the local level depend on the roles and responsibilities performed by the state, and the size of the population served. The top 10 activities provided by LHD are presented in Table 9-1.

Emergency medical services (EMS) were provided by less than 5% of the LHD surveyed. The majority of EMS at the local level was provided by other governmental agencies or nongovernmental organizations (NGO).¹⁷

NONGOVERNMENTAL ORGANIZATIONS AND COMMUNITY-BASED ORGANIZATIONS

NGO and community-based organizations (CBO) including private, nonprofit agencies play an important role in the delivery of public health services. Many were created to target education, funding, advocacy, and legislation for specific public health issues. The American Cancer Society, National Safety Council, and American Lung Association are a few examples. In some localities NGO and CBO provide public health services either in partnership with the LHD or directly through contractual services.

THE PUBLIC HEALTH SYSTEM

The public health system comprises governmental public health departments and other local, state, and federal agencies together with all other entities that play a part in protecting the public's health. These other entities include, but are not limited to, NGO/CBO, public health laboratories, health care providers, hospitals, medical and health related schools, and EMS agencies. A high degree of collaboration and cooperation among these partners is challenging, yet extremely important to ensure a seamless, efficient, and effective system.

Given the diversity and complexity of modern threats to the health and wellness of the community, the public health system must ensure the delivery of a broad spectrum of services. Although there is often considerable overlap, specialization into various public health disciplines is necessary to ensure adequate expertise in each area of public health. Most consider chronic and communicable disease control, environmental health, social and behavioral health, maternal and child health, laboratory services, and, more recently, public health emergency preparedness and response (PHEP) to be core public health disciplines. Other public health disciplines may include school health, home health care, occupational health, forensic death investigation, and EMS.

Communicable diseases control is accomplished through prevention, investigation, and intervention including treatment. Hand washing, respiratory etiquette, and immunizations are important components of infectious disease prevention. Guidelines and schedules for immunizations are typically recommended at the federal level (Advisory Committee on Immunization Practices), mandated by public health law at the state level, and operationalized (immunization clinics) and enforced (exclusion from work or school) at the local level.

Local and state health agencies investigate outbreaks of infectious disease to determine and eliminate the source and to prevent further spread. Foodborne illness, various respiratory infections (pertussis, TB, Legionella), and sexually transmitted diseases occur routinely and often require case investigation, contact tracing, and information gathering through interviews. Somewhat extraordinary measures are sometimes employed to enhance disease control efforts. Directly observed therapy (DOT) to ensure medication compliance by tuberculosis patients has become a standard of care. Expedited partner therapy (EPT), which is the provision of additional prescriptions for sexual partner(s) of patients diagnosed with chlamydia infections, has also been utilized to improve eradication.

Environmental health encompasses the theory and practice of assessing and controlling factors in the environment that can potentially affect health.¹⁸ WHO includes those external physical, biological, and chemical factors that affect human health, , and related behaviors. Environmental health services vary by jurisdiction but generally ensure the safety of food, water, air, soil, and the built environment.

Food safety and protection may include permitting and inspection of food establishments, training for food handlers, and investigation of foodborne disease outbreaks. Environmental health programs ensure the safety of public facilities frequented by members of the community such as day care centers, children's camps, swimming pools and spas, beaches, hotels and motels, migrant worker camps, body piercing and tattoo parlors, and hair salons and barber shops. Statutory and/or regulatory requirements often mandate lifeguards, adequate chlorination, safety plans, sterilization, and placement of automated external defibrillators (AED). Other threats addressed by environmental health include childhood lead poisoning; radon and indoor air quality; tobacco use in public places; public and private water systems; septic systems; land-use planning; rabies; and vectors such as mosquitoes, ticks, and rodents.

Human behavior is one of the important determinants of health. Social and behavioral health attempts to change individual behaviors using “the carrot” and/or “the stick” approach. Education may be used to encourage safe, healthy behaviors, and governmental regulation may be used to discourage unhealthy behaviors. Behavioral change is typically difficult and gradual. There are many examples of behavioral modification addressing sexual activity; drug, alcohol, and tobacco use; and injury prevention. The “Click it or Ticket” campaign has included both education and fines to successfully increase seatbelt use to 85%.¹⁹ Recently, much attention has been focused on the use of social media to impact health-related behaviors.

Following the tragic events on September 11, 2001, the discipline of public health emergency preparedness and response has mushroomed within health departments nationwide. In large part, this is a result of the CDC's annual Public Health Emergency Preparedness Cooperative Agreements that infuse significant funds and provide guidance and technical assistance to states, territories, and LHD. This has led to a readiness to respond to a variety of emergencies and disasters ranging from severe weather events to incidents involving chemical, biological, radiological, nuclear, and explosive (CBRNE) agents. Successful mitigation hinges on an all- hazards approach and close working relationships with many local and state partners such as the American Red Cross, health care providers, schools and universities, businesses, and traditional first responders including law enforcement, fire, HAZMAT, emergency management, and EMS.

EMS AS PART OF THE PUBLIC HEALTH SYSTEM

By their very nature EMS systems are uniquely positioned in most communities since they typically fall into many camps. EMS has traditionally been closely aligned with the public safety and emergency services community. However, EMS delivers health care in the austere out-of-hospital environment and rightly should also be considered a component of the health care delivery system. In fact, EMS providers are often the true frontline of the health care system for some patients, interacting with them in their homes, workplaces, and communities. More recently, the concept that EMS is actually part of the public health system has emerged. These overlapping partnerships provide both EMS providers and EMS physicians with exciting bridging opportunities to greatly impact their communities through beneficial exploitation.

COMMONALITIES BETWEEN EMS AND PUBLIC HEALTH

A natural commonality among emergency departments, EMS systems, and public health is their service to communities at large. They provide access to all comers regardless of ability to pay. They often serve the disadvantaged. They care for citizens with all types of health needs, as well as many nonmedical needs. Perhaps most significantly, they all serve as safety nets for the population at large, and thereby support the public health initiative to reduce health disparities. EMS systems offer universal access (anyone can call for an ambulance at any time for any reason) and equitable resource availability (same equipment, same personnel every time).²⁰ Also common to public health, effective EMS must delve into many disciplines both within and peripheral to the health care. These include adult and pediatric medical and injury care, maternal and child health, mental health, lifestyle behaviors, environmental issues, community service, social service, public education, public advocacy, and even transportation service. Therefore, in addition to competent clinical knowledge and skills, EMS providers and EMS physicians should be well versed in those economic, social, cultural, psychological, environmental, and other community conditions that greatly impact their EMS systems and their patients.

A working group assembled by NHTSA, the National Association of EMS Physicians (NAEMSP), and the American Public Health Association (APHA) identified eight potential benefits in partnering EMS and Public Health efforts (Table 9-2). ²¹ Key components of this collaborative include surveillance, disaster response, screening, community education, neutralization of socioeconomic disparities, workforce development and safety, and allocation of resources. Both EMS and public health stand to gain from this symbiosis. More importantly though, leveraging this partnership will ultimately benefit the health and wellness of the populations they commonly serve.

PARTNERSHIP BENEFITS PRIMARILY TO PUBLIC HEALTH

Originally developed to stem the tide of infectious disease, traditional surveillance efforts have broadened to include the scope of injuries, domestic violence, occupational hazards, chronic medical conditions, environmental hazards, and more. Data acquisition by public health is often challenging, and EMS can be a valuable source of information. EMS frequently interfaces with impoverished, underserved, and difficult to reach communities that are also typically the focus of public health actions. Thanks to modern technology, EMS data can be made available in near real time, which is important for some public health needs. Scene information to which only EMS providers might be privy can be particularly helpful to public health for developing injury prevention strategies. From a more social perspective, EMS data may be useful for identification of unsafe living conditions for at-risk populations who can then be guided to appropriate resources.

Public health access to EMS data for surveillance purposes will likely continue to expand with the ever-increasing promotion of electronic health information. As a unique example, the US Customs and Border Protection on the US-Mexico border has used EMS call logs to screen travelers for infectious disease and then enact isolation precautions when indicated.²² In Seattle, Baer et al analyzed emergency department and EMS databases to detect an increase in carbon monoxide intoxications following a wind storm that was associated with power outages.²³ Inclusion of electronic prehospital care records by regional health information organizations or RHIOs will likely help continue to facilitate this information age transition.

EMS AGENCY ROLES IN DISEASE PREVENTION

Relevant findings from public health community health assessments may lead to primary or secondary prevention interventions. While the primary role of EMS in the community has traditionally been tertiary prevention, EMS resources can support public health–driven primary and secondary prevention programs. Prevention efforts during EMS downtime may be most cost-effective since the costs of EMS provider salaries are already fixed. However, these interventions should be flexible and brief given the unpredictable nature of the EMS schedule. Distribution of condoms along with brief sexually transmitted infection and teen pregnancy prevention information is one of numerous examples.

More involved prevention efforts can be undertaken by EMS during off-duty time. An example of the interplay between surveillance and health promotion was the creation of the Eliminating Preventable Injuries in Children (EPIC) Foundation in San Diego by local paramedics. After the tragic drowning of a young boy, EMS system data were used to create a community education and advocacy campaign to reduce childhood drowning.²⁴ Other successes include education on the use of public access AEDs²⁵; helmet and child car seat distribution; and health-fair style hypertension, diabetes, and other chronic disease screenings that often include an educational component designed to change health behaviors.

When studied by Lerner et al,²⁶ a majority of EMS professionals thought that they should participate in disease and injury prevention programs, and about a third of them reported that they actually had already provided prevention services. There are, however, barriers and shortcomings to EMS-based health promotion activities especially in the clinical arena. Health behaviors are deeply seeded and may not be amenable to change because of any single interaction. Patients may not be receptive to EMS provider educational efforts for various reasons including distraction by the acuity of their illness, inadequate respect for EMS provider advice, or simply because of minimal contact time. EMS providers may be resistant to this additional responsibility for various reasons including time constraints of the emergency clinical interaction and reluctance to acquire necessary, new skills especially without increased compensation. Brownson et al. has listed 10 strategies for overcoming these difficulties with Brown and Devine adapting these strategies for EMS-based health promotion (Table 9-3).²⁷

In addition to population-based surveillance data, EMS can actively and passively provide relevant individual patient information to public health. On a day-to-day basis this may take the form of screening and case reporting of various conditions and suspected diseases such as TB, meningitis, individuals living in squalor, and clusters of individuals with similar presentations that could have resulted from common ingestion of contaminated food, inhalation of carbon monoxide, etc. During events that are widespread and ongoing, EMS can assist public health efforts by targeted screening of individuals with radiological or chemical contamination and identification of individuals who may require isolation or quarantine because of exposure to a circulating infectious agent.

EMS SYSTEM RESPONSE TO PUBLIC HEALTH EMERGENCIES/DISASTERS

The roles EMS can play during disasters and other emergency events could also go well beyond basic information sharing. The shrinking public health workforce could be supplemented by EMS providers functioning within, as well as beyond their scope of practice. One of the marquee public health emergency preparedness functions is mass prophylaxis during epidemics and other communicable disease exposures such as might occur from a food handler with hepatitis A infection. EMS providers may be utilized to assist with the distribution and administration of vaccines, antibiotics, or other medications (eg, potassium iodine following a radiological or nuclear event), or with the transportation of citizens to a point of dispensing (POD). Although the incidence of medication errors was higher, Ablah et al found that first responder facilities had faster throughput times than hybrid and hospital facilities in a large-scale POD exercise in Nassau County, NY.²⁸

EMS providers and EMS physicians can play many other roles in support of public health. These include triage during mass casualty and epidemic events, medical screening in POD, recovery of remains from mass fatality sites such as a plane crash, decontamination of victims, provision of comfort care to moribund patients, medical support for public health workers and other responders, medical care in shelters and alternate care facilities, and assistance with infectious disease containment. This latter role could include support of voluntary and mandatory quarantine and isolation enforcement, as well as dissemination of respiratory masks, other supplies, and information to the populous to help prevent the spread of pathogens.

This concept has been formalized and operationalized in western New York. A partnership between the Erie County Department of Health (ECDOH) and the Department of Emergency Medicine at the University at Buffalo has created the Specialized Medical Assistance Response Team (SMART). Emergency medicine residents, EMS fellows, and EMS physicians remain available 24/7 to respond to events throughout the western New York region in fully equipped emergency response vehicles. Initially created in the 1990s as a way to train emergency medicine residents and EMS fellows, SMART has since grown through recruitment of other physician specialists, midlevel clinicians, nurses, EMS providers, pharmacists, respiratory therapists, mental health professionals, funeral directors, and other technical specialists who are deployed as a Medical Reserve Corps during prolonged public health events (Figure 9-2). However, along with local EMS, the EMS physician component of SMART continues to serve as the first response arm of the ECDOH to large and small public health events with any patient involvement. This partnership has led to better utilization and availability of limited resources throughout the eight county region of western New York,²⁹ and is a win-win for all parties.

PARTNERSHIP BENEFITS PRIMARILY TO EMS

EMS may benefit from guidance and other support provided by public health. Guidelines provided by public health regarding alternate standards of care and allocation of limited resources may be beneficial to EMS. These guidelines may allow EMS providers and EMS physicians to extricate themselves from ethically difficult (and perhaps impossible) rationing decisions and to redirect any criticism and legal challenges to public health.

PUBLIC HEALTH IMPACT ON EMS PROVIDER HEALTH AND WELLNESS

EMS providers themselves may be the direct beneficiaries of various public health programs including worksite wellness, immunization, and smoking cessation. Other protective actions by public health such as guidelines for personal protective equipment use, fit testing, and EMS provider isolation and quarantine measures may prove invaluable to EMS providers during communicable disease events. This became reality during the SARS outbreak that impacted Toronto EMS in 2003.³⁰ Following exposure to patients with SARS, isolation of symptomatic paramedics became necessary. In addition, a working quarantine program was developed to ensure an adequate EMS workforce remained available while minimizing the risk of further spread of the virus.

PUBLIC HEALTH SUPPORT OF EMERGENCY SERVICES

Shrinking budgets continuously threaten most public and private industries and subject them to ongoing close scrutiny. EMS is no different and may, in fact, face bigger challenges given its sizeable governmental funding. All the positive aspects of EMS may be tampered by ongoing debate regarding overuse and abuse of emergency care. As recently as this year, Governor Cuomo of New York created a Medicaid Redesign Team that quickly identified ambulance “frequent fliers” as a target to reduce costs and achieve savings.³¹ It will be important for EMS physicians and other EMS leaders to advocate on behalf of EMS to ensure that a balance is struck between cost-effectiveness and the potential for missing a true emergency.

The success of EMS leaders to advocate on its behalf will hinge in part on the overall public perception of EMS and the stature it enjoys within the community. The approval of EMS as a subspecialty of emergency medicine by the American Board of Emergency Medicine (ABEM) in September, 2010, solidified the academic history and promise of the field. Weaving EMS fellowships, as well as resident and medical student rotations in EMS into the community fabric will help further ingrain the indispensability of EMS. Arguably, the more value-added services EMS provides, the stronger the voice it will have. Insertion of EMS into public health activities and other facets of the community such as EMT classes in high schools, community CPR and first-aid training, and safety demonstrations may also help solidify its future and prevent further degradation of this community safety net.

COMMUNITY PARAMEDICINE

An emerging practice model that joins EMS and public health in many ways is currently referred to community paramedicine. In many systems, it has long been apparent that the expansion of the practice of paramedicine into a more complete health care enterprise would be considered a method of meeting the increasing need for access to health care, especially in rural environments. Community paramedicine has been described as “an organized system of services, based on local need, provided by emergency medical technicians and paramedics, that is integrated into the local or regional health care system and overseen by emergency and primary care physicians.”³² In addition to addressing the needs of patients who frequently call 9-1-1 due to a lack of access to nonemergency primary care services, there appear to be very real possibilities of utilizing paramedics for home health assessments, physical therapy, and to enhance hospital-based admission avoidance (aversion) programs. Demonstration projects are underway in numerous communities around the county and professional organizations like the National Association of Emergency Medical Technicians (NAEMT), the American Academy of Family Physicians (AAFP), the American College of Emergency Physicians (ACEP), and the National Association of EMS Physicians (NAEMSP) are working to evaluate this new area of practice and to help guide the development of this new area of EMS medicine. The utilization of prehospital providers to immunize, treat, and provide preventative health services without transport will require continued development of an alternative funding methodology, including changes in the reimbursement of services by government and private insurance programs.

CONCLUSION

EMS providers and EMS physicians have a somewhat comprehensive and extraordinary perspective of the interface between the health care system and society at large. This affords them with an opportunity to contribute to, and potentially influence, public health policy decisions. Active EMS involvement in advocacy, research, and other public health endeavors can spark excitement and job satisfaction among both EMS providers and EMS physicians. Career ladders in EMS are often limited for EMS providers, and expansion into various public health programs could be another source of vocational fulfillment. EMS physicians can help plug many gaps in the limited clinical expertise in many governmental public health departments. Their support of public health is truly valuable, and could lead to other career opportunities, as well as funding, academic, research, and other partnering possibilities.

KEY POINTS

• Public health is the “the science and art of preventing disease, prolonging life, and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities, and individuals.”¹

• Public health focuses on primary prevention (interventions to avert the onset of disease) and secondary prevention (screening for asymptomatic disease to avoid disease progression and onset of clinical symptoms). EMS focuses on tertiary prevention (treatment of symptomatic disease).

• The public health system includes governmental public health departments along with many other governmental and nongovernmental entities including EMS that have the common goal of protecting the public's health.

• The National Highway Traffic Safety Administration's Office of EMS leads federal EMS efforts.

• Partnerships between EMS and public health can be mutually beneficial and can increase vocational, advocacy, funding, academic, research, and other opportunities for EMS providers and EMS physicians.

• Three core functions of public health include assessment, policy development, and assurance.

• Public health focuses on primary prevention to avert onset of a disease or injury and secondary prevention to screen for asymptomatic disease, while EMS typically focuses on tertiary prevention which includes treatment of symptomatic disease or injury.

• Key components of EMS and public health collaboration include surveillance, disaster response, screening, community education, neutralization of socioeconomic disparities, workforce development and safety, and allocation of resources.

REFERENCES

INTRODUCTION

Clinical research is an essential feature of modern medical practice. Although most areas of medicine present challenges to conducting high-quality controlled studies, the prehospital and emergency care environments are particularly challenging due to numerous uncontrolled variables inherent in developing and implementing meaningful and ethical consent processes. Despite this, an ever-growing body of research in the area of EMS Medicine has helped solidify the subspecialty and moved prehospital care toward a more evidence-based practice. EMS physicians and medical directors must be able to interpret the literature and should aid in its advancement whenever possible.

OBJECTIVES

• Describe basic research concepts and definitions.

• Describe patient groups and study designs.

• Describe scientific levels of evidence and grades of recommendation.

• Standardized reporting of clinical trials.

• Describe the development of EMS research.

• National Research EMS Agenda.

• Describe the design of an EMS study, including development of the research question.

• Describe the usual IRB process and approach to clinical research.

• Describe the concept of emergency exception for informed consent.

• Describe community consultation and public disclosure.

• Define basic statistical terms.

• Describe some basic research pitfalls.

• List existing EMS research databases and discuss how to request access to the data.

• List sources of potential funding for EMS-related research.

RESEARCH

Scientific research is meant to draw investigators and readers of the scientific literature closer to “the truth.” Study design and limitations of conducting research in the clinical environment can drastically affect the results of clinical research, potentially altering the truth being sought. In cases where meticulous design considerations have limited the presence of bias and error, it is possible to utilize study results to advance the practice of medicine. This is the basis for the concept of evidence-based medicine. Acknowledging that not all research study results lead to applicable medical practices, it is important to consider how to best interpret current EMS research results and design future studies.

BASIC SCIENTIFIC CONCEPTS AND TERMS

In order for EMS physicians to provide state-of-the-art medical direction and oversight of EMS systems, a basic grasp of the methodology behind clinical research is required. Research concepts and the definitions of common research terms are prerequisites for this understanding.

EFFICACY

Efficacy is a description of how well the treatment works in clinical trials (“explanatory”).

EFFECTIVENESS

Effectiveness refers to how well the treatment works in the practice of medicine (“pragmatic”).

VALIDITY

Validity in research is the degree to which a tool measures what it claims to measure. The validity of a study refers to determining the likelihood that the conclusions drawn from the study are correct or reasonable. A valid study asks the appropriate questions, uses the correct sample (in size and character), collects the correct outcome measures, and utilizes correct statistical methods. This is a very complex process that requires strict adherence and reassessments to produce a truly valid study.

Internal validity: Internal validity considers the direct effect of one variable (the independent variable) on another variable (the dependent variable). It is important in studies designed to show cause-and-effect relationships. At times, even properly designed studies may have confounding variables that interfere with internal validity.

Confounding variables: There are eight types of confounding variables that interfere with internal validity: (1) history—specific events occurring between measurements (in addition to any experimental variables); (2) maturation—participant changes over time (eg, becoming tired, growing older, etc); (3) testing effect—the effect that taking the first test has on taking any additional testing; (4) instrumentation— refers to changes in measurement tool calibration or the changes in observers that may change measurements; (5) statistical regression—when selected groups are selected based on their extreme score; (6) selection bias—results from the differential (nonrandom) selection of respondents for the comparison groups; (7) experimental mortality—the loss of participants from comparison groups; (8) selection-maturation interaction—occurs when participant variables (eg, hair or skin color) and time variables (eg, age, obesity) interact.¹

External validity: Relates to the extent to which the results of a (internally valid) study remain true in other cases (ie, different populations, places, or times). Can the study findings be generalized? Are the research participants representative of the general population? Many studies are performed in a single geographic area, with smaller samples or patients, who also possess unique characteristics or are representative of a specific population only (ie, volunteers, military cadets, medical students). Studies that are not generalizable have low external validity. Other factors adversely affect external validity include (1) testing effect; (2) selection bias; (3) experimental arrangements— which are not generalizable to patients in a nonexperimental setting; and (4) multiple-treatments interferences—effects of previous treatments that interfere with present testing and are not erasable.

Internal versus external validity: It might appear as if internal and external validity contradicts each other. If a strict adherence to experimental designs control as many variables as possible, the study may have high internal validity. Yet, this highly artificial setting lowers the external validity. Alternatively, in performing observational research, it is difficult to control for interfering variables and lowers the low internal validity. However, the study of environmental or other measures in a natural setting results in higher external validity. Fortunately, these apparent contradictions are resolvable, as a great many studies primarily wish to deductively test a theory, in which the major consideration is the rigor (internal validity) of the study.

BLINDING

Blinding refers to procedures undertaken to ensure that neither the study participants nor any member of the study team know to which group the participant belongs (treatment or nontreatment). Some studies have been classified as single, double, or triple blinded, depending on whether it was the participants, care team, or outcome assessors that were blinded. It is currently accepted that investigators should refrain from this terminology and simply state the type of blinding within the test of the paper.²

• Unblinded/open/open label: These are trials without blinding.

INCLUSION CRITERIA

Inclusion criteria are conditions that must be met for the appropriate recruitment of subjects into a clinical study.

EXCLUSION CRITERIA

Exclusion criteria are conditions that must be met for the appropriate rejection of subjects from a clinical study.

STUDY ANALYSES

There are different paradigms for performing analysis of data from clinical studies. When attempting to limit bias and evaluate the effect of introducing a clinical intervention on a particular population it is best to utilize a study design that incorporates intention-to-treat analysis. Other poststudy analysis and interim analysis may be appropriate in some circumstances, but the conclusions drawn from these may be less accurate.

Intention–to-treat (ITT) analysis: The objective is to analyze each group exactly as they existed upon randomization. A true ITT analysis is possible only when complete outcome data are available for all randomized subjects. This means to include all subjects, including those that drop out. ITT analyses decrease outcome bias.

Subgroup analysis: Analyzing groups within the groups being studied. Subgroup analyses are discouraged because multiple comparisons may lead to false-positive findings that cannot be confirmed.

Interim analysis: A pretrial strategy for stopping a trial early if the results show large outcome differences between groups. It allows for periodic assessments for beneficial or harmful effect of treatment compared to concurrent placebo or control group while a study is ongoing. It is used as a cost-saving measure and importantly the ethical obligation that only the minimum number of patients should be entered into a trial to achieve the study's primary objective and reduce the participants' exposure to the inferior treatment. This analysis may occur following the inclusion of a certain number of treatments or after a set period of time. However, the way in which the interim analysis is to be conducted must be expressly stated in the study protocol. Additionally, the results of the interim analysis should be evaluated by an independent data monitoring committee.³ Other reasons to stop an interim analysis are that there are unacceptable side effects or toxicity, accumulation is so slow that the trial is no longer sufficient, outside information makes the trial unnecessary or unethical, poor execution compromises the studies' ability to meet its objectives, or disastrous fraud or misconduct.

SCIENTIFIC BIAS

Bias usually refers to any unintended influence that a particular facet of the study design may have that will alter or skew the results. Typically investigators seek to limit bias as much as possible; however, much of the medical literature is affected by bias in some form.

Selection bias: Usually results from an error in choosing the individuals or groups to participate in a study. It distorts the statistical analyses and may result in drawing incorrect conclusions regarding the study outcome(s). It weakens internal validity.

Sampling bias: A systematic error in a study that occurs because the participants do not represent a random sampling of the population. This occurs in some instances due to participant self-selection or prescreening of trial participants. The result is that some members of the population are less likely to be included than others. It weakens external validity.

Attrition bias: A kind of selection bias caused by the loss of participants. It includes patients that dropout or do not respond to a survey (nonresponders), or who withdraw or deviate from the study protocol. It results in biased results because a study intervention or nonintervention is unequal or underrepresented in the outcome.

Publication bias: A bias regarding what is most likely to be published, positive or negative findings. If negative findings are underreported, it leads to a misleading bias in the overall published literature. Studies suggest that positive studies are three times more likely to be published than negative studies. Trial registration is now required by many journals to ensure that unfavorable results are not withheld from publication.⁴

RANDOMIZATION

Participants are arbitrarily assigned to a treatment (intervention) or nontreatment (control) group. Randomization eliminates bias in group assignment, aids in blinding the investigator, participants, and other assessors from knowing the grouping of study participants, and allows the use of probability theory to express the likelihood that any outcome differences between groups merely indicate a chance finding.

Cluster randomization: A preexisting group of study participants (schools, poisoning victims, families) are randomly selected to receive (or not receive) an intervention. Cluster randomization is sometimes done due to factors related to study participants (ie, all family members are placed in the same treatment or nontreatment group)

Factorial randomization: Each participant is randomly assigned to a treatment (or nontreatment group) that receives a particular combination of interventions (or noninterventions).

Randomization procedure: Generation of an unpredictable sequence of allocations to be distributed to participants to treatment or control groups using an element of chance, following the patient's evaluation of eligibility and recruitment into the study.

Allocation concealment: Very strict protocols to ensure that patient group assignments are not revealed prior to their allocation to a group. Sequentially numbered, opaque, sealed envelopes (SNOSE) is a type of allocation concealment

TRIAL REGISTRATION

As of July 1, 2005, the International Committee of Medical Journal Editors (ICMJE) announced that all RCTs must be registered to be considered for publication in member journals. This registration may occur late.⁵

PATIENT GROUPS

During the design phase of a study, it is important to define groups. Based on the study type, there may be several different types of groups needed for a particular study.

Control group: A patient group that receives no treatment

Placebo control group: A patient group that receives no treatment, but will receive a “sham” or “placebo” treatment that will mimic what is being performed in the “test group” but without physiological or real effect.

Parallel group: Participants are randomly allocated to a group, and study participants either receive or do not receive an intervention.

Crossover group: Participants are randomly allocated to a group, and, over time, all study participants receive and do not receive an intervention in a random sequence.

EVALUATING THE SCIENTIFIC LITERATURE

Certain attributes of studies produce better evidence than others. It is important to consider the design of the study when determining how to interpret a study. Some studies may have seemingly ideal designs, whereas others do not. The constraints of design related to the clinical environment many times limit the investigators' ability to design a study with all of the ideal parameters. In general, the following attributes can be used to distinguish between stronger and weaker level of evidence.

• Randomized studies are superior to nonrandomized ones.

• Prospective studies are superior to retrospective studies.

• Blinded studies (in which patients, and clinicians and data analysts where possible, do not know which intervention is being used) are superior to unblinded studies.

• Controlled studies are superior to uncontrolled ones.

• Experimental study designs are superior to observational study designs.

• Contemporaneous (occurring at the same time) control groups are superior to historical control groups.

• Internal control groups (ie, managed within the study) are superior to studies with external control groups.

• Large studies (ie, involving enough patients to detect with acceptable confidence levels any true treatment effects) are superior to small studies (ie, properly powered studies are superior to underpowered studies).

• Studies that clearly define patient populations, interventions, and outcome measures are superior to those that do not clearly define these parameters.

TYPES OF CLINICAL TRIALS

RANDOMIZED CONTROLLED TRIAL

In a randomized controlled trial (RCT), subjects are assessed for eligibility and recruitment into the trial. Then, before the intervention or treatment begins, the patients are randomly allocated to receive one treatment or another of the treatments being studied. After the patients are randomized to one treatment arm or the other(s), they are followed in exactly the same way, with the only difference between the two groups being the randomly allocated treatment(s). RCTs are the gold standard for a clinical trial. They are often used to test the efficacy or effectiveness of various types of medical interventions within a patient population. An RCT must contain a control group or a previously tested treatment (a positive-control study). The advantage of an RCT is that they are so strictly controlled that they reduce study bias and the confounder of causality. The disadvantages of RCTs are that they are very expensive, time consuming, may have lower external validity, and perhaps unethical for certain orphan diseases (rare) or rapidly morbid or mortal conditions or injuries which do not lend themselves to RCT evaluation. The types of RCTs are listed below.

Superiority trials: Most RCTs are superiority trials, wherein one intervention is hypothesized to be significantly superior to another.

Noninferiority trials: These RCTs seek to determine whether a new treatment is no worse than an established treatment.

Equivalence trials: These RCTs seek to determine whether two interventions are indistinguishable from each other.

RANDOMIZED (UNCONTROLLED) CLINICAL/COMPARATIVE TRIAL

A randomized (uncontrolled) clinical/comparative trial is a trial that compares multiple treatment groups with each other in the absence of a control group.

NONRANDOMIZED TRIAL

These types of studies also called quasi-experimental studies. They do not have random assignments to either a control or treatment group. In these studies, the researcher controls the assignment to a grouping (ie, sicker patients receive the treatment) or circumstances dictate grouping (ie, patients presenting on nights and weekends are allocated to the control arm). These studies typically have lower internal validity because the two groups may not have comparable baselines.

OBSERVATIONAL STUDIES

Observational studies typically are designed to follow patients of a particular type, or whom have specific common features or risk factors.

Cohort studies: These studies are longitudinal studies, in that they look at an effect of an intervention on a patient population over time. It may assess risk factors in a group of patients who share common characteristics (ie, diabetes or heart disease risk factors) and it may or may not compare the effect of the study intervention to a comparison group (ie, a similar group of patients without the intervention) or to historical groupings previously studied. Several types of cohort studies are discussed below.

Prospective cohort studies: A study that sets out to evaluate patients that present forward from some set time. They usually seek to determine risk factors that affect the studied group over time. These are important studies in that it is unethical to perform such as study as an RCT and purposely expose patients to risk factors. Prospective studies are of a higher level of evidence than retrospective studies.

Retrospective cohort studies: These studies are also called historic (post hoc) cohort studies. They review the records of patients that have already been treated or an event that has already taken place. These studies are easier to complete than prospective studies, less expensive and may allow for the study of rare diseases. The disadvantages are that some important statistical measures cannot be made and significant biases (selection and informational) may confound the results. Moreover, these studies rely on precise record taking that has already taken place, which may have key data points, epidemiological, or treatment information missing or unavailable.

TIME SERIES STUDIES

Time series studies are studies run through a period of time, in order to test a hypothesis or make an observation.

Case-controlled study: This is an observational study in which two groups with different outcomes are identified and compared. These studies are often performed to identify contributing factors in patients with a particular condition with patients who do not have that particular condition. They are simpler to perform than other studies and less expensive. Additionally, they are usually used as preliminary studies for research questions related to topics that have limited known information. However, the conclusions drawn may be weaker than more rigorously performed studies.

Nested case-control study: This variation of a case-controlled study evaluates only a subset of controls from the cohort to the incident cases. This subset is selected to match risk sets with the incident cases. In a case-cohort study all incident cases are compared. These studies may be analyzed using methods that take missing covariates into consideration.

Cross-sectional studies: These studies are also called cross-sectional analyses, transversal studies, or prevalence studies. These are observational studies involving either all members of a population or a representative subset of that population, at a specific point in time.

Ecological study: This is an epidemiological study in which large populations, rather than individuals are evaluated. These studies are considered inferior to cohort and case-controlled studies because of the concept of ecological fallacy (a false interpretation of the data made because inferences are made regarding individuals based on inferences from the group to which those individuals belong).

SCIENTIFIC LEVELS OF EVIDENCE

This is a ranking system used in evidence-based medicine to assign a strength rating to a clinical trial or research study. There are five levels of evidence (I, II, III, IV, and V) with alphanumeric subsets (Table 10-1).

GRADES OF RECOMMENDATION

These are ranking of the strength of medical evidence. These “grades” are based on the level of scientific evidence on the subject matter and used in clinical practice guidelines to summarize work quality of the literature (Table 10-2).

STANDARDIZED REPORTING OF CLINICAL TRIALS

The interpretation of clinical trials measuring effects of interventions on clinical outcomes is made more complex by inherent variability in the way trials have been designed and their results reported. This is made even more clear when attempting to compare and contrast results of multiple trials on the same intervention. Meta-analysis studies can be made more complex (a potentially less meaningful) when the body of literature on a particular intervention is limited by nonstandard reporting of outcomes/results.

OUTCOMES

Outcome research was introduced by health care research leaders such as Codman (1910) and Donabedian (1966). Outcome measurement is clearly a defining component of medical research. The various types of outcome measures include physical/clinical (mortality), performance/function (self-care), economic (cost/benefit), and humanistic (quality of life).⁶ When measuring outcomes it is common to utilize outcome measurement/indicator tools. These may be general health/generic measures, disease-specific measures, or functional status measurement tools. The tools may represent a direct measure of a desired outcome, or a tool designed to demonstrate an outcome that cannot be directly measured. These may be considered surrogate endpoints in some cases. Clinical endpoints may also be categorized as primary (one of more endpoints that have been powered for rejection of the null hypothesis), secondary (other prespecified endpoints that have been powered for hypothesis testing), and tertiary (exploratory). Endpoints can also be categorized by type of data as well (Table 10-3).⁷

In some cases, authors will combine endpoints after data analysis and may show statistic significance based on the combined outcome, despite the lack of significance when evaluating each independently. This may lead to some confusion and is not considered to be the preferred methodology.

Consolidated Standards of Reporting Trials 

Consolidated standards of reporting trials (CONSORT) is a collection of initiatives developed by the CONSORT Group to help ameliorate problems that may arise from inadequate reporting of RCTs. The main objective of the CONSORT Group is the development of the CONSORT Statement.⁸ This is a minimum set of recommendations for the reporting of RCTs that is standardized and promotes “transparent reporting,” the reduction of bias, and aids readers in their appraisal and interpretation of the RCT. The most recent version contains a 25-item checklist for researchers as well as a flow diagram with descriptive text. There is an additional document called the CONSORT “Explanation and Elaboration” document that is advocated strongly for concomitant use with the CONSORT Statement.⁹

DEVELOPMENT OF EMS RESEARCH

CURRENT AREAS OF FOCUS

The current areas of focus in EMS research are in the prehospital clinical sciences, EMS systems, and the EMS education realms. The current clinical areas of focus are out-of-hospital cardiac arrest (OHCS), major trauma, stroke, shock, and spinal immobilization. Systems-based areas of focus include transport of specialty patients, STEMI coordinated care, stroke coordinated care, trauma coordinated care, and ED crowding/ off-load times. Some educational areas of focus include evidence-based decision making in EMS, advanced-airway adjuncts, integration of advanced practice providers (ie, physician assistants, nurse practitioners), and community paramedicine.

COMPONENTS OF A SUCCESSFUL PROGRAM

Development of a successful research program can be a significant undertaking and may represent considerable investment in time and funds. In order to maximize return on the investment it is important to consider the components required for successful development.

Training: In an EMS system, researchers may come from a variety of different backgrounds. Basic and advanced training in study design, participant expectations, ethical principles, study development, and statistical analyses is advised. Many institutions provide modules on these topics, and the facility's Institutional Review Board (IRB) may be an invaluable resource.

Mentorship: In many studies, mentorship is essential. For those just beginning a research study, the mentorship of a seasoned investigator is very much advised. Many institutions, universities, and medical centers have such experienced mentors available.

Collaboration: Teaming up with like-minded researchers from related fields is advisable in many situations (Figure 10-1). For example, a study related to an advanced airway adjunct may benefit from collaborators from emergency medicine, surgery, and anesthesiology. Collaboration allows different viewpoints and experience to be shared among researchers, often leading to a more efficient and streamlined area of focus.

NATIONAL EMS RESEARCH AGENDA

The National EMS Research Agenda, published by the National Highway Transportation and Safety Administration in 2001, provides an assessment of the state of EMS research and recommendations for the continued advancement of this critical area.¹⁰ This document outlines areas of weakness and specific challenges that limit the advancement of EMS research programs. It advocates for policy changes and enhanced funding for the development of researchers, research centers, and studies. Additionally, it proposes a greater organization of stakeholders to ensure research finders are utilized in the development of evidenced-based practice. The recommendations of the authors of the document are illustrated in Table 10-4 (paraphrased from the executive summary).

STUDY DESIGN

FORMING A WORK GROUP

There is a new trend in scientific research termed team science. It involves the collaboration of researchers to enhance and further research goals. There are several types of research teams, including:

Independent research: Usually a single investigator working indepen­dently on a research question or with one or more collaborators.

Collaborative efforts: May range from independent research, to collaborative efforts among several investigators, to fully integrated research teams.¹¹

FORMULATING THE RESEARCH QUESTION(S)

One of the most apparently simply but challenging steps in the research process is formulation of the “research question.” It is the first, and possibly the most important step in the research design. It sets the basis from which the study is designed and is supposed to ensure that the study actually answers the proposed question. Prior to formulating the hypothesis and null hypothesis for any proposed study, the researcher(s) must carefully develop the research question(s).

PICO process: This process is used in evidenced-based medicine research to properly frame and answer a clinical question (Box 10-1).

FINER criteria: This is a set of criteria developed to promote the development of a good research question. (Box 10-2)¹² Box 10-1 The PICO Process

Patient problem or population to be studied

Intervention to be evaluated

Comparison between group(s)

Outcome of Study

Feasible: Adequate numbers of subjects, appropriate technical expertise, affordable study in terms of time and funding, and with an a study that is manageable in its scope

Interesting: The project outcome is intriguing to researchers, peers, and the community

Novel: The study will confirm, refute, or extend previous work

Ethical: The study conforms to IRB specifications and moral principles

Relevant: The study outcome is pertinent to existing scientific knowledge, clinical and/or health care policy, and future research

REFINEMENT OF RESEARCH QUESTIONS, HYPOTHESES, AND RESEARCH OBJECTIVES

After the initial development of the research question is complete and stakeholders are satisfied with the basic principles surrounding the investigation, the question and hypotheses must be further elucidated and refined in order to define the specific research objectives. This can be accomplished by following a basic set of steps.

1. Systematic literature review: This is often the first step undertaken. It is performed to develop an understanding of previous work, the overall level of evidence of the subject matter, controversies in the literature, and knowledge gaps within the field study.

2. Intensive review of scientific trends and technological advancements within the field of study: This is important to assess the rigor with which the proposed study must be performed in order to align with the current highest levels of investigation.

3. Question refinement review(s): The question, once developed, must be shared with mentors, colleagues, and collaborators so that it can be refined and honed into the simplest yet most complete question that encompasses the proposed scope of the investigation.

4. FINER criteria review: Is then used to further test the appropriateness of the research question.

5. PICO criteria: Reapplied to ensure that appropriate aspects of the question are addressed.

6. Development of a research hypothesis: From the research question.

7. Development of primary and/or secondary objectives: This is done prior to commencement of the study and listed in the IRB and the formal study protocol.

Null Hypothesis 

This is the standard or “default” assumption/prediction made at the outset of scientific inquiry. It reasons that there will be no significant difference in outcomes between two groups treated in different ways. One can reject or disprove a null hypothesis. However, a null hypothesis cannot be accepted or proven.

Alternative Hypothesis 

This is the rival hypothesis to the null hypothesis. It states that there will be a significant difference in outcomes between two groups treated in different ways. If the null hypothesis is rejected, the alternative hypothesis is accepted.

BASIC STATISTICAL CONCEPTS

At times it may be appropriate to review study results and then apply a particular statistic methodology in order to satisfy a previously undefined research objective. However, in most cases the study design should include the statistical methodology by which results are to be sought prior to submission and implementation of the study design. It is important to understand the types of measures and the errors that can occur during this phase, and to choose appropriate statistical methodology.

MEASURES OF CENTRAL TENDENCY

Mean: This is probably the most often used descriptive statistic measured. It measures the “central tendency” of a variable and is usually reported with confidence intervals. It is usually calculated as the mathematical average of a set of values. For numbers 1, 3, 5, 7, 13, 25, 27, and 30, the mean is 15.85.

Median: The median is the value for which 50% of the observations will lie above that value and 50% will lie below that value (when all values are ranked). For numbers 1, 3, 7, 13, 25, 27, and 30, the median is 13.

Mode: The mode is the value that appears most often in a data set. It is the value most likely to be sampled. For numbers 1, 3, 7, 13, 13, 13, 25, and 27, the mode is 13.

Type I errors: or “false-positive” errors—an incorrect rejection of a true null hypothesis. It wrongly concludes that a treatment has a positive effect when it does not.

Type II errors: or “false-negative” errors—an incorrect acceptance of a false null hypothesis. It wrongly concludes that a treatment has a negative effect, when it actually is a positive study with regard to treatment significance.

P Value: A P value helps determine the significance of study results. It is a number between 0 and 1. The smaller the P value (≤0.05), the stronger the evidence against the null hypothesis (the null hypothesis is rejected). The larger the P value (>0.05), the weaker the evidence against the null hypothesis and the null hypothesis is not rejected.

MEASURES OF DISPERSION

Standard deviation (SD): The SD determines how much variation from the average exists with a data set. A low SD indicates that the data are very close to the mean. A high SD indicates that the data are spread out over a large range of values. The SD is the square root of its variance. It is used to measure confidence in statistical conclusions.

Standard error of the mean (SEM): The SEM is the standard deviation (SD) of the different sample means. Approximately 68.3% of the sample means would be within one SEM and 95.4% would be within two SEMs and 99.7% would be within three SEMs.

Confidence intervals: A range of values around the mean where it is expected that the true mean is located. For example, if the mean = 23 (p = 0.05) and the lower and upper confidence intervals are 19 and 27, respectively, then there is a 95% probability that the population mean is >19 and <27. Smaller P values result in wider confidence intervals. The confidence interval depends on the sample size and the variation of data values. Confidence intervals are based on the assumption that the variable is normally distributed in the population being studied. Larger sample sizes have more reliable means. The larger the variation, the less reliable the mean.

DIAGNOSTIC TESTING

Sensitivity: Sensitivity is also called the true positive rate or the recall rate. It describes how well a test can detect a disease or condition in those that have the disease or condition. Sensitivity helps rule out disease when the result is negative (Sensitivity Rule Out = “Snout”). Sensitivity = true positives/(true positives + false negatives).

Specificity: Specificity refers to the percentage of people who test negative for a specific disease among a group of people without the disease. A highly specific positive test, it is highly certain that the patient actually has the disease (Specificity Rule In = “Spin”). A very specific test rules in a disease with a high degree of confidence. Specificity = true negatives/(true negatives + false positives).

Positive predictive value: This test asks the question: “If the test result is positive, what is the probability that the patient actually has the disease?” PPV = true positives/(true positives + false positives).

Negative predictive value: This test asks the question: “If the test result is negative, what is the probability that the patient does not have the disease?” NPV = true negatives/(true negatives + false negatives).

Likelihood ratios: A likelihood ratio is the ratio of two probabilities of the same event under different circumstances. It uses the sensitivity and specificity of a test to determine whether a test result usefully changes the probability that the condition exists. A positive likelihood ratio = sensitivity/1 – specificity. A negative likelihood ratio = 1 – sensitivity/specificity. A likelihood ratio >1 indicates that the test result is associated with the disease. A likelihood ratio <1 indicates that the result is associated with absence of the disease.

Odds ratios: The odds ratio measures the association between an exposure and an outcome. It represents the odds that an outcome will occur given a particular exposure, compared to the odds of the outcome occurring in the absence of that exposure. It is calculated by using a two-by-two frequency table.

STATISTICS TERMS

Sample size calculation: This is a very important part of a study design that is performed to determine the appropriate number of subjects in each group that will be needed to make a valid inference about the population from which the subjects are taken.

Variable: An object or event that is being measured or evaluated.

Independent variable: A variable that is not changed by other variables being measured or assessed (ie, age, gender, education). When assessing the relationship between variables, one is usually attempting to discern if the independent variable caused a change in the other variables (the dependent variables). Independent variables may cause a change in a dependent variable. However, dependent variables cannot cause a change in an independent variable.

Dependent variable: A variable that may change, depending on the effects of other variables (ie, a test score is dependent upon prior night's restfulness and/or the duration or quality of pretest preparation).

Correlation: A correlation is a measure of the relation between two or more variables.

Pearson correlation: The most widely used type of correlation coefficient. It is also known as the linear or product correlation. It is used to determine the extent to which values of two variables are proportional to each other.

Proportionality: The extent to which two or more variables are linearly related (approximated by a straight line sloping either upward or downward). The line is called a regression line (or least squares line) and is determined such that the sum of the squared distances of all of the data points from the line is the lowest possible.

Correlation coefficients: Can range between −1.00 and +1.00.

Negative correlation: The value of −1.00 represents a perfect negative correlation. With a negative correlation, the relationship between two variables is such that as the value of one variable increases, the value of the other variable decreases.

Positive correlation: The value of +1.00 represents a perfect positive correlation. With a positive correlation, the relationship between two variables is such that as the value of one variable increases, the value of the other variable also increases.

No correlation: The value of 0.00 represents a complete lack of correlation between two or more variables.

TRADITIONAL STATISTICAL METHODS

STUDENT T TEST

The Student t test is used to determine if two sets of data are significantly different from each other. It is usually used to assess if any significant difference occurs between groups in response to an intervention measured with the same statistical unit or whether the slope of a regression line differs significantly from zero.

ANALYSIS OF VARIANCE

Analysis of variance (ANOVA) is a collection of statistical models used to analyze differences between group means and their associated interventions. It is used for comparing three or more groups' means for statistical significance. It assesses the “variation” both among and between groups. It tests whether or not the “means” of groups are equal. It generalizes the t test to more than two groups. When three or more groups are being compared, it is better to use ANOVA rather than performing multiple two-sample t tests (which might increase the chance of a type I error).

REGRESSION ANALYSIS

This is a process for evaluating the relationships among measured variables. It focuses on the relationship between a dependent variable and one or more independent variables and aids in the understanding of how the value of the dependent variable changes when any one of the independent variables is varied (while the other independent variables remain fixed.).

THE USE OF HUMANs IN RESEARCH STUDIES

There have been a large number of experiments that have been performed on humans that were unethical, illegal, and immoral. These experiments include deliberately infecting people with debilitating or deadly diseases, exposing subjects to biological weapons, chemical weapons, radiation, torture, interrogation techniques, mind-altering substances, and other similar types of testing. Often these “studies” were performed on at-risk patient populations (pregnant women, children, racial minorities, the mentally disabled, the sick, the elderly, the poor, and prisoners). These types of studies have been banned for 40 years and stringent regulations have been instituted to ensure human subjects are heavily protected from exploitation and dangerous clinical trials.

THE NUREMBERG CODE

The Nuremberg Code is a set of research ethics and principles for human experimentation that resulted from the Nuremberg trials at the end of World War II (1947). It was developed in response to the “Doctors Trial” involving 23 doctors that conducted human experiments in concentration camps on German citizens.

THE DECLARATION OF HELSINKI

The Declaration of Helsinki is a set of ethical principles on human experimentation developed in 1964 by the World Medical Association and is considered the “cornerstone” document of human research ethics.

POLICIES FOR THE PROTECTION OF HUMAN SUBJECTS

This document was created by the National Institutes of Health in 1966. It recommended the establishment of IRBs to oversee clinical studies involving human subjects.

THE NATIONAL RESEARCH ACT

This legislation was established by the National Commission for the Protection of Human Subjects in 1974 and mandated that the Public Health Service develop regulations to protect the rights of humans involved in research studies.

BELMONT REPORT

The Belmont Report was issued in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It outlines the ethical principles for research on humans. It was initiated at the Belmont Conference Center, which was once part of the Smithsonian Institution. The report was prompted by concerns related to the Tuskegee Syphilis Study. It outlines three fundamental ethical principles for any human subject research:

Respect for persons: Especially as it relates to the autonomy of all people and in treating them with courtesy and respect. It discusses informed consent and the duty that all researchers have to be truthful and without deception.

Beneficence: This is the philosophy of “do no harm” and in minimizing research subject risk while maximizing research benefits.

Justice: This doctrine ensures that reasonable, nonexploitive, and well thought-out procedures are administered fairly and equally.

The “Common Rule”: The Federal Policy for the Protection of Human Subjects came into effect in 1981, following the 1975 revision to the Declaration of Helsinki. It was fully encapsulated and published in 1991. It contains five subparts.

Subpart A: Contains the “Common Rule” which outlines the basic provisions for IRBs, informed consent, and assurances of compliance.

Subpart B: Provides additional protections for pregnant women, fetuses, and neonates.

Subpart C: Provides additional protections for prisoners.

Subpart D: Provides additional protections for children.

Subpart E: Provides additional protections for the registration of IRBs.

INSTITUTIONAL REVIEW BOARDS

Institutional Review Boards (IRBs) are also called ethical review boards and have been instituted worldwide to formally approve, monitor, and review all biomedical and behavioral research involving human subjects. These tasks are accomplished through uniform procedures and reviews that involve a risk-benefit analysis of the proposed research.

DUTIES OF AN IRB

The primary focus of any IRB is to ensure that human subjects are protected from exposure to any potential harm.

EXEMPTIONS FROM IRB REVIEWS

IRB reviews are universally mandated in all but a few circumstances. Some of these exceptions include those involving the study of differing educational practices or testing, staffing instructional studies, curriculum studies, management methods, some surveys, observation studies (unless electronically recorded or those that contain identifiable information), and in some cases research involving the collection of existing data already in a system (deidentified data).

INFORMED CONSENT

A cornerstone of an IRB process is the obtainment of permission prior to performing an intervention. The subject must understand the risks, benefits, implications, and future consequences of either treatment or nontreatment. The patient must also have appropriate reasoning faculties and the capacity to understand the entire informed consent document. It is very important that the patient understand that in research trials, the patient may not be allocated to the treatment group. Studies have consistently shown that many RCT subjects believe that they are certain to be in the treatment group, not understanding the difference between research treatment (therapeutic misconception).¹³

EMERGENCY CONSENT

In the United States, between 1979 and 1993 emergency research involving critically ill patients who could not reasonably consent was often considered to be performed under a concept known as waived consent. However, in 1993 the branches of the Department of Health and Human Services (DHHS) charged with review and development of policy relative to clinical research found that there was no clear guidelines by which investigators could safely and ethically evoke waiver of consent for emergency research. This led to an ensuing debate and a 1993 federal moratorium on all research without prospective informed consent. Due to disagreement concerning the specific intent of components of the Common Rule, in 1995 the Final Rule was introduced and was intended as a mechanism investigator to establish enrollment parameters for emergency research and exception from informed consent in place of the previous waiver method.

EXCEPTION FROM INFORMED CONSENT

Final Rule, 61 Fed. Reg. 51498 (Oct. 2, 1996) 21 CFR 50.24 defined the new standard for this process. The new 1996 standard for emergency research involves the investigator(s), study sponsors, IRB, and also the general public.

In order to be considered for eligibility for granting of exception from informed consent (EFIC) by the IRB a specific set of eligibility criteria must be met.¹⁴ The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence is necessary to determine the safety and effectiveness of particular interventions.

1. Obtaining informed consent is not feasible because:

   1. The subjects will not be able to give their informed consent as a result of their medical condition

   2. The intervention under investigation must be administered before consent from the subjects' legally authorized representatives is feasible

   3. There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation

2. Participation in the research holds out the prospect of direct benefit to the subjects because:

   1. Subjects are facing a life-threatening situation that necessitates intervention

   2. Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects

   3. Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity

3. The clinical investigation could not practicably be carried out without the waiver.

4. The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent.

5. The IRB has reviewed and approved informed consent procedures and an informed consent document consistent with 50.25.

   The process requires five major components:

   1. Community consultation: There must be consultation with the leaders of the community about the research design and plans.

   2. Public disclosure: The investigators (and sponsor) must inform the community about the research.

   3. Multiple consent process: Investigators must prepare and utilize informed consent: a standard informed consent for the participant, a form for the family or legally authorized representative (proxy informed consent), and a consent to continue in the research.

   4. Independent data monitoring: The study data must be monitored independently to ensure ethical practices relative to early termination in cases of harm (or poor risk/benefit ratio) based on interval results.

   5. Community reporting: Investigators are also required to inform the community of the study's results and the demographic characteristics of the participants.