Regulatory oversight of emergency medical services occurs primarily at the state level based on the provision laid out in the Emergency Medical Services (EMS) Systems Act of 1973. Despite this fact various levels of regulation exist at various levels of government in order to address the needs of the overall system. In addition to governmental agencies, some nongovernmental entities have produced standards that have been adopted by many jurisdictions (federal and state), making them de facto parts of the regulatory structure, despite their lack of regulatory authority.
Discuss federal regulations that directly and indirectly impact EMS systems.
Discuss the states’ provision of EMS and give examples of different state EMS organizational systems.
Give examples of local, regional, state, and federal regulatory organizations that govern/oversee EMS systems.
Discuss how no governmental organizations influence regulation of EMS.
While the laws, regulations, and policies that regulate EMS within the United States flow from our federal government for EMS operations within our borders, some EMS agencies transport across these borders. International operations, such as fixed-wing aircraft EMS, must be aware of and in compliance with a variety of international laws and regulations. In particular, transport of controlled substances, licensing of providers, and operation of aircraft outside of the United States require particular attention. Any international EMS operation, including disaster relief, repatriation via commercial aircraft, and any cross-border ambulance transport should enquire about these issues prior to initiating operations.
The history of federally regulated EMS in the United States dates from the 1960s, when physicians returning from the Vietnam War noted differences between military medicine and civilian EMS. In 1966, the Institute of Medicine published Accidental Death and Disability, the Neglected Disease of Modern Society, also known as the EMS White Paper.1 This report argued effectively that the lack of civilian EMS and trauma care was leading to many avoidable disabilities and deaths. Congress followed by funding regional EMS system development in 1973 with addition of the Emergency Medical Services (EMS) Systems Act of 1973 (42 U.S.C. 300d) to the Public Health Service Act. This empowering legislation provided funding for states to establish EMS systems. Subsequent funding, including specific funding for EMS for children efforts, has aided in further development and regulation of EMS in the United States.
In addition, specific federal legislation, such as that regulating transfer of patients between facilities, reimbursement of healthcare providers, release of medical information, control of pathogens, and other topics are of particular importance to EMS. While not an inclusive list, the outline below describes in brief several federal agencies and other organizations that act at a national level to regulate EMS in the United States.
The Department of Transportation, National Highway Traffic Safety Administration, EMS Division, or DOT NHTSA EMS is the federal home for EMS in the United States.2 NHTSA is the origin of a variety of educational and funding initiatives, including the EMS Agenda for the Future, the National Scope of Practice Model, and National EMS Core Content. Their office acknowledges a variety of other federal agencies that are involved in leadership for a comprehensive national EMS system, ranging from the Office of Rural Health Policy to the Centers for Disease Control and Prevention. (SeeBox 22-1.) NHTSA EMS provides coordinating leadership and funding that substantially controls the curriculum for EMT training in the United States, the scope of practice generally accepted for EMTs at various levels, and interstate coordination and cooperation of EMS systems.
Box 22-1 Federal Agencies with EMS Responsibilities in Addition to DOT/NHTSA
Department of Health and Human Services
Office of the Assistant Secretary for Preparedness and Response
Agency for Healthcare Research & Quality (AHRQ)
Emergency Medical Services for Children (EMSC)
Indian Health Service
Centers for Disease Control and Prevention (CDC)
Department of Homeland Security
Office of Health Affairs
U.S. Fire Administration
National Fire Academy
Federal Communications Commission
Public Safety and Homeland Security Bureau
The US Drug Enforcement Administration (DEA)3 is a branch of the US Department of Justice, and enforces the laws and regulations of the United States relating to controlled substances. When EMS agencies use controlled substances, such as narcotics and benzodiazepines, they must comply with DEA regulations. Typically, this involves a physician medical director or physician acting with similar authority who prescribes or orders these controlled substances for the ambulance service, and then a series of policies and procedures, which provide control over access to use of and inventory of these drugs. Failure to properly comply with these regulations and/or discovery of drug diversion may constitute significant legal and regulatory concern for the involved physician.
The Federal Aviation Administration (FAA) is the federal agency that controls the operation of aircraft and the licensing of aircrew in the United States. Therefore, it is involved in helicopter and fixed-wing aircraft EMS operations.4 While operation of an aircraft and EMS medical care may seem like clearly distinct areas, there is overlap and controversy. It appears that the FAA is attempting to clarify that its authority is limited to operation of the aircraft and the qualifications of the crew, and that the medical system determines whether there is need for patient transport by aircraft. However, controversies include decisions about federal versus state regulatory authority, the safety of medical helicopter operations, and the aviation qualifications of medical flight crew.5 For example, does the FAA or a state EMS agency have the authority to control whether a helicopter ambulance can respond to certain types of patient problems, where it can land, and what equipment and capabilities are available in the patient compartment? Are the medical crew, often EMTs and/or nurses, subject to FAA aircrew regulations, including duty work hours and drug testing? These and other controversies are currently under discussion (2011).
The US General Services Administration (GSA), among many other activities, offers minimum requirements to meet federal specifications for patient transport ambulances.6 These specifications, known as KKK-1822, are updated every 5 years, and are currently in revision F.7 As can be seen in Box 22-2, the GSA specifications refer to a number of laws and specifications from other agencies and organizations. In addition, the National Fire Protection Administration (NFPA) has developed a standard for ambulance construction as well. This standard, NFPA 1917, went into effect in 2012 and will likely be merged with the KKK specifications in the future.8
Box 22-2 GSA KKK-1822F Referenced Standards and Regulations*
The following standards and regulations form a part of this specification, to the extent specified or required by law. Unless a specific issue of a standard or regulation is identified, the issue in effect, on the date the ambulance is contracted for, shall apply.
FEDERAL SPECIFICATIONS:
RR-C-901C—CYLINDERS, COMPRESSED GAS: HIGH PRESSURE, STEEL DOT 3AA AND ALUMINUM APPLICATIONS
FEDERAL STANDARDS:
Federal Standard No. 297—Rustproofing of Commercial (Nontactical) Vehicles
MILITARY STANDARDS:
MIL-STD-461 Requirements for the Control of Electromagnetic Interference Characteristics of Subsystems and Equipment.
MIL-STD-1223 Non-tactical Wheeled Vehicles, Painting, Identification Marking, and Data Plate Standards.
LAWS AND REGULATIONS:
29 CFR 1910.1030: Blood borne Pathogens
29 CFR 1910.7 Definition and Requirements for a Nationally Recognized Testing Laboratory
21 CFR 820: Quality System Regulation
40 CFR 86: Control of Air Pollution from New Motor Vehicles and New Motor Vehicle Engines.
47 CFR, PART 90: Public Safety Radio Services (FCC)
49 CFR 393: Federal Motor Carrier Safety Regulations (FMCSR)
49 CFR 571: Federal Motor Vehicle Safety Standards (FMVSS)
2.2 OTHER PUBLICATIONS.
The following documents form a part of this specification to the extent specified. Unless a specific issue is identified, the issue in effect, on the date the ambulance is contracted for, shall apply.
THE TIRE AND RIM ASSOCIATION, INC.
Yearbook
NATIONAL FIRE PROTECTION ASSOCIATION
70—National Electric Code
1901—Standard for Automotive Fire Apparatus
2. APPLICABLE DOCUMENTSSOCIETY OF AUTOMOTIVE ENGINEERS (SAE), INC., STANDARDS, AND
RECOMMENDED PRACTICES:
J163 Low Tension Wiring and Cable Terminals and Splice Clips
J537 Storage Batteries
J541 Voltage Drop for Starting Motor Circuits
J553 Circuit Breakers
J561 Electrical Terminals, Eyelet, and Spade Type
J575 Tests for Motor Vehicle Lighting Devices & Components
J576 Plastic Materials, For Use In Optical Parts Such As Lenses and Reflectors of Motor Vehicle
Lighting Devices
J578 Color Specification for Electric Signal Lighting Devices
J595 Flashing Warning Lamps for Authorized Emergency, Maintenance, and Service Vehicles
J638 Test Procedure and Ratings for Hot Water Heaters for Motor Vehicles
J639 Safety Practices for Mechanical Vapor Compression Refrigeration Equipment or Systems Used
To Cool Passenger Compartment of Motor Vehicles
J689 Approach, Departure, and Ramp Break over Angles
J682 Rear Wheel Splash and Stone Throw Protection
J683 Tire Chain Clearance
J858 Electrical Terminals, Blade Type
J928 Electrical Terminals, Pin, and Receptacle Type
J994 Backup Alarms, Performance Test and Application
J1054 Warning Lamp, Alternating Flashers
J1127 Battery Cable
J1128 Low Tension Primary Cable
J1292 Automobile, Truck, Truck-Tractor, Trailer, and Motor Coach Wiring
J1349 Engine Power Test Code, Spark Ignition and Diesel
J1318 Strobe Warning Lights
J2498 Minimum Performance of the Warning Light System Used on Emergency Vehicles
NATIONAL TRUCK EQUIPMENT ASSOCIATION / AMD:
AMD STANDARD 001—AMBULANCE BODY STRUCTURE STATIC LOAD TEST
AMD STANDARD 002—BODY DOOR RETENTION COMPONENTS TEST
AMD STANDARD 003—OXYGEN TANK RETENTION SYSTEM STATIC TEST
AMD STANDARD 004—LITTER RETENTION SYSTEM STATIC TEST
AMD STANDARD 005—12-VOLT DC ELECTRICAL SYSTEM TEST
AMD STANDARD 006—PATIENT COMPARTMENT SOUND LEVEL TEST
AMD STANDARD 007—PATIENT COMPARTMENT CARBON MONOXIDE LEVEL TEST
AMD STANDARD 008—PATIENT COMPARTMENT GRAB RAIL STATIC LOAD TEST
AMD STANDARD 009—125V AC ELECTRICAL SYSTEMS TEST
AMD STANDARD 010—WATER SPRAY TEST
AMD STANDARD 011—EQUIPMENT TEMPERATURE TEST
AMD STANDARD 012—INTERIOR CLIMATE CONTROL TEST
AMD STANDARD 013—WEIGHT DISTRIBUTION GUIDELINES
AMD STANDARD 014—ENGINE COOLING SYSTEM TEST
AMD STANDARD 015—AMBULANCE MAIN OXYGEN SYSTEM TEST
AMD STANDARD 016—PATIENT COMPARTMENT LIGHTING LEVEL TEST
AMD STANDARD 017—ROAD TEST
4AMD STANDARD 018—REAR STEP AND BUMPER STATIC LOAD TEST
AMD STANDARD 019—MEASURING GUIDELINES: CABINETS & COMPARTMENTS
AMD STANDARD 020—FLOOR DISTRIBUTED LOAD TEST
AMD STANDARD 021—ASPIRATOR SYSTEM TEST, PRIMARY PATIENT
AMD STANDARD 022—COLD ENGINE START TEST
AMD STANDARD 023—SIREN PERFORMANCE TEST
AMD STANDARD 024—PERIMETER ILLUMINATION TEST
AMD STANDARD 025—MEASURING GUIDELINES: OCCUPANT HEAD CLEARANCE ZONES
AMERICAN COLLEGE OF EMERGENCY PHYSICIANS (ACEP):
Guidelines for Ambulance Equipment
AMERICAN SOCIETY FOR TESTING AND MATERIALS (ASTM) STANDARDS:
F 920 Standard Specification for Minimum Performance and Safety Requirements for
Resuscitators Intended for Use with Humans
F 960 Standard Specification for Medical and Surgical Suction and Drainage Systems
D 4956 Standard Specification for Retroreflective Sheeting for Traffic Control
D6210 Standard Specification for Fully-Formulated Glycol Base Engine Coolant for
Heavy-Duty Engines
B117 Standard Practice for Operating Salt Spray (Fog) Apparatus
IPC-610D Acceptability of Electronic Assemblies
NATIONAL EMSC (EMERGENCY MEDICAL SERVICES FOR CHILDREN) RESOURCE ALLIANCE:
COMMITTEE ON AMBULANCE EQUIPMENT AND SUPPLIES
Guidelines for pediatric equipment and supplies for Basic and Advanced life support ambulances
AUTOMOTIVE MANUFACTURERS EQUIPMENT COMPLIANCE AGENCY(AMECA):
Approval of Motor Vehicle Safety Equipment (emergency lights and sirens)
AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI):
Z535.1 American National Standard for Safety Colors
For assistance in obtaining the referenced documents, contact the Department of Commerce, National Technical Information Service (NTIS).
*From www.deltaveh.com/f.pdf. Accessed May, 2015.
Related posts:
Full access? Get Clinical Tree
