Laws and Regulations Affecting Emergency Medical Services in South Carolina
A. EMS Legislation and Regulation
The Department of Health and Environmental Control (DHEC) is charged with the development and enforcement of standards and regulations for emergency medical services. The agency's authority to regulate is found in two documents: Act 1118 of 1974 and Regulation 61-7. (See EMS Law and Regulation 61-7 Appendices.) Act 1118 of 1974, as amended in 1975, 1981, 1986, 1997 and 2006 provides the legislative framework of the emergency medical system in South Carolina. The essential elements of Act 1118 include:
- Creation of the state EMS Advisory Council.
- Authority to issue EMT service and EMT First Responder agency licenses and permits for ambulance vehicles.
- Authority to revoke or suspend EMT service or EMT First Responder agency licenses, ambulance permits, or certifications of personnel.
- Authority to issue certificates for the successful completion of training courses.
- Authority for emergency medical technician to function in South Carolina.
In 1995, an act was passed to amend Title 44 by adding Chapter 78, the Emergency Medical Services Do Not Resuscitate Act (EMS DNR Act). This act allows EMS personnel to honor written DNR orders on the adult terminally ill patient.
Promulgated pursuant to authority contained in Act 1118, Regulation 61-7 provides specific standards and procedures to be followed to ensure compliance with the law. As with Act 1118, subsequent amendments have been made to Regulation 61-7. These amendments reflect changing standards and requirements and, most recently, the changing role of the medical control physician.
In 1996, legislation was passed to allow DHEC’s EMS division to license EMT First Responder agencies. EMT First Responder agencies are those which operate at an EMT level or above. These EMT First Responder agencies can be licensed to respond to emergencies and provide care and treatment, but cannot transport patients. Generally, these agencies are paid fire departments, industries and possibly some volunteer fire departments. These agencies also are required to have medical control physicians.
This legislation became effective on January 1, 1997, and Regulation 61-7 was revised to add the regulations for EMT First Responder agencies and to incorporate some general revisions.
Regulation 61-7 is divided into sixteen separate sections. The sections are:
- I. Scope of Act 1118
- II. Definitions
- III. Enforcing Regulations
- IV. Licensing Procedures
- V. Permits, Ambulance
- VI. Standards for Ambulance Permits
- VII. Equipment
- VIII. Sanitation Standards for Licensed Providers
- IX. Training and Certification
- X. Personnel Requirements
- XI. Revocation or Suspension of Certificates of EMTs
- XII. Air Ambulances
- XIII. Patient Care Reports
- XIV.EMS DNR Order
- XV. Severability
- XVI. General
B. Responsibilities of EMS Services Under State Law
If one wishes to become an EMS service provider, one must first acquire a valid operator's license. Section 44-61-40 of Act 1118 authorizes DHEC to issue licenses to approved operators. Section IV of Regulation 61-7 details the requirements that must be met prior to the issuance of a license.
Section 44-61-90 of Act 1118 requires that the licensed EMS providers maintain records that include, but are not limited to, patient care forms, employee/member rosters, time sheets, call rosters, and training records.
Section 44-61-90 requires much of the licensed EMS provider. He or she must make certain that the employees are properly certified, the patient care forms are completed accurately, and the ambulances are equipped with at least the minimum required equipment. Although the operator may delegate these responsibilities, he or she bears the ultimate responsibility.
C. Intermediate and Advanced Life Support as Defined by State Law
Advanced life support is afforded one citation in Act 1118. A 1981 amendment to Section 44-61-130 states that:
"Emergency medical technicians, trained to provide advanced life support and possessing current Department of Health and Environmental Control certification, are authorized to possess limited quantities of drugs, including controlled substances. . ."
The section further states that EMTs (actually EMT-P’s) may administer those drugs "pursuant to the written or verbal order of a physician possessing a valid license to practice medicine within this state provided such physician is registered under the state and federal laws pertaining to controlled substances."
Regulation 61-7 gives precise definitions of intermediate and advanced life support. Section II of Regulation 61-7 gives the following definitions:
- Advanced Life Support - "Treatment of life-threatening medical emergencies through the use of techniques such as endotracheal intubation, administration of drugs or intravenous fluids, cardiac monitoring, and defibrillation by a qualified person pursuant to these regulations."
- Advanced Life Support Service - "A service provider that in addition to basic life support minimum standard, provides at least 2 EMT’s, one of which is an EMT-Intermediate or Paramedic and demonstrates the capability to provide IV therapy, advanced airway care, approved drug therapy, cardiac monitoring and electrical therapy on 80% of all emergency calls.”
- Intermediate Life Support Service - "A service provider that, in addition to basic life support minimum standard, provides at least 2 EMT’s, one of which is an EMT-Intermediate or EMT-Paramedic and demonstrates the capability to provide IV therapy and advanced airway care on 80% of all emergency calls."
- EMT First Responder Agency - “A licensed agency providing medical care at the EMT-Basic level or above, as a non transporting first responder.”
Section 702 of Regulation 61-7 lists the additional equipment that must be carried by ambulances providing intermediate and advanced life support.
D. EMTs and the Law
Section 44-61-80 of Act 1118 requires that each emergency medical technician obtain a valid EMT certificate. In order to receive certification, EMTs of all levels must complete the appropriate training course or courses. The EMT must also successfully complete state administered examinations unless his or her service has a state approved in-service training program that allows him or her to exempt the state practical examination. Emergency medical personnel, at all levels, receive certification for a period of three years.
Section 44-61-80 also gives DHEC the authority to suspend or revoke a certificate if it is determined that the individual no longer meets the qualifications.
Section IX of Regulation 61-7 provides the details of the certification process for all levels of training for pre-hospital professionals.
The EMTs of all levels may perform only those skills that are taught in the curricula of the respective courses. EMT-I’s and EMT-P’s may not perform advanced life support procedures unless authorized by a physician licensed in the state of South Carolina. Physician supervision should be direct, by standing orders, or by radio and telecommunications. Again, EMT-B’s, EMT-I’s, and EMT-P’s may not perform skills that are not on the state approved skills list, except in the case of approved pilot programs.
How do these laws and regulations affect you as a medical control physician? You are the prime mover in the advanced life support system. Any EMT who initiates an ALS procedure is performing that skill under your medical license; therefore, it is to your advantage to know that the EMT is competent in that skill. The only way to do this is by personal observation.
As you are probably aware, lawsuits are all inclusive in many cases. You can be held liable for the mistakes of your charges. The best means of preventing a lawsuit is to know your personnel and other capabilities. It is also important that you remain abreast of changing standards in emergency medical services. Do not be complacent; constantly challenge and question.
The character of the local EMS system is shaped to a large degree by your participation. Strive for excellence!
E. EMS DNR Act
In the past EMT service providers had been asked to honor DNR orders of a patient or facility but were bound by the lack of legislation that would enable them to honor the DNR order. This was resolved with the passage of Title 44, Chapter 78 as amended, the Emergency Medical Services Do Not Resuscitate Act, or as it is commonly known, the EMS DNR Act. This Act allows emergency medical personnel to legally recognize and follow the adult terminally ill patient's desire to have EMS personnel withhold resuscitative treatment as outlined on the EMS DNR (Do Not Resuscitate) Form.
The EMS DNR Order Act applies only to resuscitative attempts by EMS personnel. The execution of other advance directives does not effect, and may not be substitute for, the EMS DNR Order. The EMS DNR Order must be executed even though the patient may have executed other advanced directives.
The following may request an EMS DNR Order from the patient's physician: an adult patient who has a terminal condition and has the capacity to provide informed consent; a surrogate for an adult patient with a terminal condition under the Adult Health Care Consent Act; an agent of a person with a terminal condition named by the patient by a Health Care Power of attorney. The health care provider’s records must contain the time, date and medical condition that give rise to the diagnosis of a terminal condition.
An EMS DNR (Do Not Resuscitate) Form (Appendix), issued by the EMS division, may not be altered or torn and must be signed by the patient (or his/her agent or surrogate), and by the patient's physician. The form must also contain the phone number and address of the patient's physician. The patient may be transported by EMS with an original, signed, DNR order or a copy of the DNR order. The sample DNR order included in the appendix of this book may be used, or, according to regulations, an EMS DNR order may be drafted in “substantially” the same form as shown in the regulations.
The form should be in a location where it is easily observed and recognized by the EMS personnel. It should also be displayed in such a manner that it will be visible and protected at all times. An EMS DNR marker may be worn, but is not required. If a marker is worn, it should be a bracelet or necklace, as approved by the EMS division.
The EMS DNR order may be revoked at anytime by the oral expression of the patient to EMS personnel or by the mutilation, obliteration or destruction of the EMS DNR (Do Not Resuscitate) Form in any manner. If the order is revoked, EMS personnel should perform full resuscitation and treatment of the patient.
If no EMS DNR (Do Not Resuscitate) Form is found when EMS personnel report to a scene, resuscitative measures should be initiated. If, after starting resuscitative measures, an EMS DNR (Do Not Resuscitate) Form is later found, resuscitative measures should be stopped.
No health care provider or EMS personnel are liable for any damages or may be the subject of disciplinary proceedings or may be subject to civil or criminal liability due to:
- issuing an "EMS DNR Order"
- good faith reliance on an "EMS DNR Order" resulting in:
- the withholding of resuscitative treatment; or
- the withholding of resuscitative treatment already in progress once a duly executed EMS DNR Order is found;
- initiating resuscitative treatment on a patient who has an executed EMS DNR Order, if EMS personnel were unaware of the existence of the Order of if EMS personnel reasonably and in good faith believed the EMS DNR Order had been canceled or revoked; or
- initiating resuscitative treatment on a patient who has an executive EMS DNR Order, where in the best medical judgment of EMS personnel, the care was necessary to relieve pain or suffering or to provide comfort care to the patient.
F. Special Licensure Requirements for Distribution of Controlled Substances
South Carolina Regulation 61-4 requires that a physician who serves as a medical control physician for an EMS service must obtain a separate South Carolina Controlled Substances Registration from DHEC, as well as a separate Federal Drug Enforcement Registration (DEA) in the name of the EMS service if controlled substances are in the possession of, or are administered by the EMS service.
The controlled substances currently allowed by the state-approved drug list (see Drug List Appendix) are Morphine, Valium (diazepam), Versed (midazolam hydrochloride), Ativan (lorazepam) and Fentanyl (suvlimaze).
If an EMS service has a county or municipal affiliation only one registration is required for all units. If an EMS service is privately owned, a registration for each unit is required.
Physicians are reminded that both DHEC and the DEA should be notified of any changes in the EMS address or EMS medical control physician.
Application blanks for both state and federal registrations may be obtained from the Bureau of Drug Control, 2600 Bull Street, Columbia, SC 29201, (803) 935-7817.
Theft or loss of controlled substances must be reported to the DEA and the Bureau of Drug Control on DEA Form 106.
Unused controlled substances should be destroyed by the registrant, an EMS agent or hospital attendant in the presence of a witness.
G. HIV and EMTS
An EMT or paramedic may not refuse to care for a patient because that patient is infected with Human Immunodeficiency Virus (HIV), the virus which causes Acquired Immunodeficiency Syndrome (AIDS). The EMT or paramedic must follow the guidelines of the Centers for Disease Control and take the proper precautions when treating all patients. Also, employers of health care workers, including EMTs and should keep themselves apprised of OSHA requirements.
LEGAL QUESTIONS AND ISSUES SHOULD BE DISCUSSED IN DEPTH WITH SUPERVISORS AND LEGAL ADVISORS AS APPROPRIATE. THIS SERVES ONLY AS A CURSORY REMINDER OF SOME OF THE LEGAL ISSUES OF WHICH EMTS SHOULD REMAIN AWARE.
H. Hazardous Wastes
Frequently the question arises about who is responsible for cleaning up blood and body tissues left on the scene after an EMS transport. The classic example of this occurs during the treatment of a patient involved in a motor vehicle accident or some other type of trauma. The patient is treated, packaged and transported by EMS. However, due to the mechanism of injury, there may be blood, body fluids and body tissue found at the scene, in the vehicle, road or surrounding areas. Who is responsible for the cleanup of this hazardous medical waste?
The process of rapid assessment, packaging, stabilization and transportation to a trauma facility is most often carried out by a two-person ambulance crew and can result in the generation of infectious waste. It is reasonable to expect that all waste generated by the EMS unit in the treatment and transport of a patient should be cleaned up by EMS. This waste includes, but is not limited to, dressings, bandages, needles, syringes, oxygen adjuncts, medical products packaging materials, articles of clothing contaminated with blood or body fluids which were removed to treat the patient, etc. Any equipment and/or supplies used by EMS for the purpose of treatment and/or transportation of the patient must be removed by EMS from the scene and properly disposed of according to OSHA/DHEC regulations.
Waste generated by the patient, such as blood, body fluids, or body tissues found at the scene either in the interior or on the exterior of a vehicle or in the surrounding areas, should be cleaned up by or removed by a third party. If the incident occurred on private property, i.e. homes, businesses, construction sites, etc., the cleanup of this material should be the responsibility of the owner or proprietor. If the incident occurred on public property, i.e. highways, parks, etc., the cleanup should be the responsibility of the maintenance personnel that normally are responsible for that public property.
I. Investigation Review Committee
The Emergency Medical Services Act of South Carolina, Section 44-61-70(a) states that:
“The appropriate official of the department having authority over emergency services shall have authority to recommend suspension of the license, certificate or permit of any person, firm, corporation, association, county, district, municipality, metropolitan government or agency for noncompliance with this chapter or the standards or the rules and regulations promulgated pursuant thereto.”
Section 44-61-80(e) gives the EMS division authority to:
“suspend or revoke a certificate so issued at any time it is determined that the holder no longer meets the prescribed qualifications set forth by the department or has failed to provide to patients emergency medical treatment of a quality deemed acceptable by the department or is guilty of misconduct as outlined by the rules and regulations.”
Regulation 61-7, Section XI, defines instances which constitute misconduct and which can result in the revocation or suspension of an EMT’s certificate.
The Investigative Review Committee (IRC) allows for input in this procedure by a group of qualified representatives from outside the EMS division. The IRC is composed of the state medical director, the four regional training coordinators (not including the region being investigated), a field paramedic (selected by the EMS Directors Association) and one Medical Control Committee member.
At the time a complaint is received, the EMS division will notify the EMS provider affected by the complaint, and the medical control physician if the complaint involves a patient care issue.
Any decision which will result in a revocation of an EMT’s certificate or provider’s license must be approved by the DHEC Board.
For additional information, call (803) 545-4204