16 Del. Admin. Code § 4301 – Advanced Life Support Interfacility Transportation

Department of Health and Social Services

Division of Public Health

Emergency Medical Services

4301 Advanced Life Support Interfacility Transportation

1.0 Purpose

1.1 The purpose of this regulation is to permit the use of paramedics, under the oversight of the Division of Public Health, Office of Emergency Medical Services (OEMS), to manage patients while in transit between medical facilities or within a healthcare system.
1.2 This regulation includes approval processes for an organization to provide a service with a paramedic, as well as to define the organization’s scope of practice and medical oversight. Data reporting to the Division of Public Health is included for the purposes of evaluating the performance of the state EMS system, of which interfacility transportation is a component, regardless of the level of medical care provided.
1.3 Additional functions of the OEMS as it relates to advanced life support interfacility transport are found in 16Del.C.Ch. 97.

2.0 Authority

2.1 This regulation is promulgated under the authority of 16Del.C.Chs. 97 and 98.
2.2 The statewide paramedic program, a "coordinated advanced life support system under qualified medical supervision", was established under the direction of the Office of Emergency Medical Services, Division of Public Health, Department of Health and Social Services. (16Del.C.§9801(a))
2.3 The transfer of patients to specialty care, or rehabilitation, or follow-up care centers is within the scope of the state EMS system (16Del.C.§9705(j)). The use of paramedics to facilitate these transfers is a function of the statewide paramedic program. (16Del.C.§9801(g))
2.4 The OEMS is responsible for providing assistance and advice for activities related toward the planning, development, improvement, and expansion of emergency medical services (16Del.C.§9704(a)). This includes ‘monitoring and evaluating transportation services in Delaware to assure that patients in the EMS system have access to effective and efficient transportation to appropriate treatment facilities. (16Del.C.§9705(d))
2.5 The OEMS is primary staff to the Delaware Emergency Medical Services Oversight Council (DEMSOC), in addition to functioning as the body having jurisdiction over the state paramedic program. In this capacity, OEMS shares the responsibility for "monitoring the [state] EMS system to ensure that all elements are functioning in a coordinated, effective, and efficient manner to reduce morbidity and mortality for the citizens of Delaware and to ensure quality of emergency medical services". (16Del.C.§9703)

3.0 Definitions

The following words and terms, when used in this regulation, have the following meaning:

"911 ALS organization" means an EMS organization that has been designated to provide ALS services to calls originating from a 911 center.

"ACLS" means the American Heart Association Advanced Cardiac Life Support course.

"Advanced life support" or "ALS" means the advanced level of prehospital and interhospital health care that includes basic life support functions plus cardiac monitoring, cardiac defibrillation, electrocardiography, administration of anti-arrhythmic agents, intravenous therapy, administration of specific medications, drugs and solutions, intravenous therapy, and other authorized treatments and procedures.

"ALS-IFT" means advanced life support interfacility transport.

"ALS interfacility transportation" means the medically necessary transportation of a patient requiring the provision of medical care that exceeds the scope of practice of an EMT-Basic.

"ALS-ITO" means an organization or service that provides advanced life support interfacility transportation.

"Ambulance" means any publicly or privately owned vehicle, as certified by the State Fire Prevention Commission, that is specifically designed, constructed, or modified and equipped, intended to be used for and is maintained or operated for the transportation upon the streets, highways, and waterways of this state for persons who are sick, injured, wounded, or otherwise incapacitated or helpless.

"BCLS" means the American Heart Association Basic Cardiac Life Support course.

"Board of Medical Licensure and Discipline" or "BMLD" means the body that oversees medical practice in Delaware under 24Del.C.Ch. 17.

"Certification process" means the process by which a paramedic certified in another state may receive reciprocity to work in the State of Delaware. (Refer to 24Del.C.§1700.)

"Designation" means status provided by the Division of Public Health to an ambulance service allowing them to provide advanced life support interfacility transportation.

"Designation suspension" means the organization may not provide ALS interfacility transportation services until recommended changes are implemented and reviewed by the OEMS.

"Division" means the Division of Public Health.

"Emergency call system" means any request for medical assistance that is received by a 911 public safety access point (PSAP).

"Emergency medical technician" or "EMT" means a person who has been trained and currently certified in emergency care procedures through a course which meets the objectives of the national scope of practice.

"EMS"means emergency medical services and is a system that responds to emergencies in need of highly skilled pre-hospital specialists and clinicians.

"EPCR" means the Electronic Patient Care Report utilized by the State of Delaware to document patient contacts by providers.

"Interfacility transportation" means the transfer of a patient between 2 medical facilities.

"Medical director"meansa Delaware licensed physician who is certified by the American Board of Emergency Medicine, the Osteopathic Board of Emergency Medicine, or has received approval as an ambulance medical director by the Delaware Office of Emergency Medical Services. The medical director shall be the chief physician for the ambulance service and under whose license all EMS providers of the ambulance service shall operate for the purpose of providing services pursuant to the Delaware advanced life support standing orders.

"Medical facility" means an agency, institution, or establishment where people receive acute, inpatient, outpatient, or long-term health care.

"OEMS" or "Office" means the Office of Emergency Medical Services, Division of Public Health.

"Organization" means an ALS interfacility transportation organization

"Organization Medical Director" means the medical director hired or contracted to oversee the medical care provided by an ALS-ITO.

"Paramedic" means a person who hassuccessfully completed a course approved by the Board of Medical Licensure and Discipline or its duly authorized representative, documented by OEMS, recognized by the Commission as a Delaware EMT while in the performance of their duties with a county paramedic service or State agency.

"Physician" means an individual authorized to practice medicine in Delaware under 24Del.C.Ch.17.

"PSAP" means public safety access point, such as a 911 center.

"Registered nurse" means an individual authorized to practice registered nursing in Delaware under 24Del.C.Ch. 19.

4.0 General Provisions

4.1 ALS interfacility transportation organizations will provide access to their services without discrimination due to race, color, creed, sex, nationality, age, or disability.
4.2 All organizations employing the services of paramedics to provide ALS interfacility transportation in the State of Delaware are subject to all the provisions and limitations of this regulation and oversight by the Division of Public Health except:
1. 4.2.1 Organizations owned or operated by or under the jurisdiction of the federal government and used exclusively for government purposes.
2. 4.2.2 Agencies or organizations whose ambulances travel through Delaware, regardless of frequency exclusively for the purpose of interstate travel where patients are neither discharged nor picked up in the State.
3. 4.2.3 An organization based outside of Delaware that transports patients to and from Delaware for diagnostic or therapeutic services within the same calendar day.
4.3 No person, agency, or organization may operate, conduct, maintain, advertise, engage in, or profess to engage in, advanced life support interfacility transportation services in Delaware utilizing paramedics as advanced life support providers unless the agency or person holds a current designation certificate from the Division of Public Health except for:
1. 4.3.1 Organizations owned or operated by or under the jurisdiction of the federal government and used exclusively for government purposes.
2. 4.3.2 Organizations whose units travel through Delaware, regardless of frequency, exclusively for the purpose of interstate travel where patients are neither picked up nor dropped off in the state.
3. 4.3.3 An organization based outside of Delaware that exclusively transports a patient to and from a Delaware location for diagnostic or therapeutic service within the same calendar day.
4.4 If a vehicle is used to provide transportation services, or an organization provides transportation services that are both excepted and non-excepted under this regulation, its ambulance, clinical providers, and operator shall comply with this regulation when not operating as an excepted service or organization.
4.5 If the Division of Public Health believes that an ambulance is picking up or discharging patients and is required to be functioning under this regulation, the Division or an appointed representative may require the crew and management to provide information sufficient to determine whether the organization is required to comply with this regulation or is exempt.
4.6 Organizations that provide interfacility transportation services that originate within the State of Delaware but do not utilize paramedics for advanced life support interfacility transportation, must comply with only subsections 9.7 and 11.3.1.2 of this regulation.
4.7 All communication regarding this regulation should be directed to:
Delaware Division of Public Health
Office of Emergency Medical Services
100 Sunnyside Road
Smyrna, DE 19977
Email:OEMS@Delaware.gov
4.8 Public Information
1. 4.8.1 The Division of Public Health shall maintain a current list of designated advanced life support interfacility transportation organizations (ALS-ITOs). The list shall contain the name of the ALS-ITO and their unit designations that will be used in radio communications.
2. 4.8.2 The Delaware Freedom of Information Act (29Del.C.Ch. 100) shall govern responses to requests for public records from the Division of Public Health.

5.0 Patient Service Expectations

5.1 Each ALS-ITO shall provide every patient with:
1. 5.1.1 Considerate and respectful care;
2. 5.1.2 Information necessary to give informed consent for treatment, transport, or both;
3. 5.1.3 The opportunity to refuse treatment or transport when competent to do so;
4. 5.1.4 Reasonable privacy concerning a patient’s transportation and care;
5. 5.1.5 Confidentiality of all communication and records related to patient transportation and care except as otherwise required by law;
6. 5.1.6 Reasonable response to a request for service once the ALS-ITO is engaged to provide service;
7. 5.1.7 Reasonable continuity of care once the ALS-ITO is engaged to provide service;
8. 5.1.8 An opportunity to examine and receive an explanation of the patient’s bill;
9. 5.1.9 An environment in the ambulance that is free from hazards and annoyances to include:
  1. 5.1.9.1 Tobacco or tobacco-like products;
  2. 5.1.9.2 Any hindrance to patient care; and
  3. 5.1.9.3 Loud conversation by the crew.
10. 5.1.10 Information about the ALS-IFT units operating in Delaware is provided by the Division of Public Health. Communication should be directed to:
  Division of Public Health
  Office of Emergency Medical Services
  100 Sunnyside Road
  Smyrna, DE 19977
  Telephone number: 302-223-2700
  Email:OEMS@delaware.gov

6.0 Designation

6.1 Purpose. To qualify an organization to provide advanced life support services in the State of Delaware under16Del.C.§9809(b).
6.2 To be eligible to apply for ALS-ITO designation, an organization shall:
1. 6.2.1 Be qualified to conduct business in the State of Delaware, evidenced by a Delaware business license, unless a non-profit corporation.
2. 6.2.2 Possess a permit from the Delaware Fire Prevention Commission as either an emergency or non-emergency BLS ambulance service. This regulation requires the organization to maintain an office of operations within the State of Delaware. Refer to DSFPC 710 Ambulance Service Regulations, subsection 7.2 (1DE Admin. Code710, subsection 7.2).
3. 6.2.3 Own or operate at least 1 ambulance that is certified by the Delaware State Fire Prevention Commission (DSFPC).
4. 6.2.4 Employ drivers that have completed the "Emergency Vehicle Operators" course conducted by the Delaware State Fire School or an equivalent program approved by the Delaware Fire Prevention Commission.
5. 6.2.5 Have insurance coverage as outlined in subsection 9.9 of this regulation.
6. 6.2.6 Have computer equipment and internet access that is compatible with integration of the Electronic Patient Care Reporting (EPCR) system and must complete, without exception, a State of Delaware EPCR on each patient contact and shall document relevant findings and treatments.
7. 6.2.7 Have a designated principal contact for communication with the Division of Public Health.
6.3 Application
1. 6.3.1 An organization seeking designation to provide ALS-IFT in Delaware shall submit a completed application on the required form to the Division of Public Health.
2. 6.3.2 A completed application will contain:
  1. 6.3.2.1 The organization’s:
    1. 6.3.2.1.1 Name;
    2. 6.3.2.1.2 Main physical business address;
    3. 6.3.2.1.3 Billing address;
    4. 6.3.2.1.4 Telephone number;
    5. 6.3.2.1.5 Email address;
    6. 6.3.2.1.6 Name of the principal contact person for communication with the Division of Public Health;
    7. 6.3.2.1.7 Name of the principal contact person for daily operations; and
    8. 6.3.2.1.8 Entity type.
  2. 6.3.2.2 Documentation that the organization is qualified to do business in Delaware and a signed agreement that it will take all actions necessary to remain qualified to do business in Delaware.
  3. 6.3.2.3 All trade names that the organization, its parent, or subsidiary has done business under for the previous 10 years.
  4. 6.3.2.4 Information about management personnel and owners:
    1. 6.3.2.4.1 Names;
    2. 6.3.2.4.2 Addresses;
    3. 6.3.2.4.3 Telephone numbers; and
    4. 6.3.2.4.4 Job titles.
  5. 6.3.2.5 Street addresses of any locations from which the organization intends to operate, including:
    1. 6.3.2.5.1 Location from which units are dispatched;
    2. 6.3.2.5.2 Location where records are kept;
    3. 6.3.2.5.3 Location where crews are quartered; and
    4. 6.3.2.5.4 Location where ambulances are parked or stored.
  6. 6.3.2.6 Information about employees who may be providing health care:
    1. 6.3.2.6.1 Name;
    2. 6.3.2.6.2 Documentation of the following certifications:
      1. 6.3.2.6.2.1 Delaware paramedic certification, or Delaware EMT-B certification;
      2. 6.3.2.6.2.2 BCLS;
      3. 6.3.2.6.2.3 Delaware emergency vehicle operator card or equivalent as approved by the Delaware Fire Prevention Commission. Refer to DSFPC 710 Ambulance Service Regulations (1DE Admin. Code710); and
      4. 6.3.2.6.2.4 Motor vehicle license.
    3. 6.3.2.6.3 Non-Delaware certified providers must receive reciprocity before they may serve inDelaware. Refer to 16Del. C. §§ 9809-9810 and 24Del.C.§1700.
  7. 6.3.2.7 Information about the Organization Medical Director:
    1. 6.3.2.7.1 Name;
    2. 6.3.2.7.2 Address;
    3. 6.3.2.7.3 Telephone number;
    4. 6.3.2.7.4 E-mail address;
    5. 6.3.2.7.5 Evidence of credentials:
      1. 6.3.2.7.5.1 Delaware medical license; or
      2. 6.3.2.7.5.2 Board certification in an appropriate specialty approved by the State EMS Medical Director.
    6. 6.3.2.7.6 A description of their role, responsibilities, and authority within the organization.
  8. 6.3.2.8 Information about the ambulances
    1. 6.3.2.8.1 A list of the units that will be utilized for ALS-IFT with tag, VIN, and unit designation.
    2. 6.3.2.8.2 Documentation from the Delaware State Fire Prevention Commission that each ambulance that the organization intends to use for ALS-IFT has received a permit for service in the State of Delaware.
    3. 6.3.2.8.3 A diagram of the numbering, lettering, and symbols that will be displayed on the units.
  9. 6.3.2.9 A copy of the operational policies of the organization. These should include policies governing responses, transport practices, security of controlled dangerous substances, and training.
  10. 6.3.2.10 Insurance Information
    1. 6.3.2.10.1 A certificate of liability insurance that verifies that coverage that complies with this regulation is in effect and lists:
      1. 6.3.2.10.1.1 Non-renewal or cancellation; or
      2. 6.3.2.10.1.2 Changes in coverage or level of insurance.
      The Division of Public Health-Office
      of Emergency Medical Services
      100 Sunnyside Road
      Smyrna, DE 1977
      as a party entitled to notification 10 days prior to any of the following changes to the insurance policies required by this regulation:
    2. 6.3.2.10.2 A certificate of motor vehicle insurance that identifies by VIN all motor vehicles covered under the insurance policy.
  11. 6.3.2.11 A description of the quality management activities in the company or organization. This description shall include samples of reports describing activities related to clinical performance and operational performance.
  12. 6.3.2.12 A signed written statement that:
    1. 6.3.2.12.1 There has been no attempt for the purpose of obtaining or attempting to obtain a designation, to knowingly and willfully:
      1. 6.3.2.12.1.1 Falsify, conceal, or omit a material fact;
      2. 6.3.2.12.1.2 Make any false, fictitious, incomplete, or fraudulent statements or representations; or
      3. 6.3.2.12.1.3 Make or use any false writing, document, or entry knowing the same to contain any false, fictitious, or fraudulent statements.
    2. 6.3.2.12.2 The signer is authorized by the organization identified on the application to sign the application form to execute the sworn statement.
  13. 6.3.2.13 Any additional information that the Division of Public Health may consider necessary.
3. 6.3.3 The application shall be signed by:
  1. 6.3.3.1 If a sole proprietorship, the owner;
  2. 6.3.3.2 If a partnership, a duly authorized partner;
  3. 6.3.3.3 If a corporation, a duly authorized corporate official; or
  4. 6.3.3.4 If a limited liability company, a duly authorized member.
6.4 Review
1. 6.4.1 The application must be completed and returned with all accompanying materials to the Division of Public Health either in person or by certified mail.
  1. 6.4.1.1 Electronic submissions are acceptable.
  2. 6.4.1.2 Incomplete applications will not be reviewed.
2. 6.4.2 The Division of Public Health will review the application of the proposed ALS-ITO, schedule an inspection, and review to determine whether the applicant organization is following this regulation and other applicable laws.
  1. 6.4.2.1 The inspection/review may include any of the following:
    1. 6.4.2.1.1 Inspection of the supporting documents;
    2. 6.4.2.1.2 A survey to inspect the ambulance service facilities, vehicles, and equipment; or
    3. 6.4.2.1.3 A conference with the applicant or applicants to provide feedback.
3. 6.4.3 The applicant will be notified in writing of the status of the application.
  1. 6.4.3.1 Approval
    1. 6.4.3.1.1 A designation certificate will be provided from the Division of Public Health if all requirements are met as discussed herein.
    2. 6.4.3.1.2 The current certificate, or a facsimile, shall be posted in a conspicuous place in each office of operations and in each ambulance that is used for ALS-IFT in the State of Delaware.
  2. 6.4.3.2 Denial
    1. 6.4.3.2.1 If the Division determines that deficiencies exist which warrant the disapproval of the application, written notice will be given to the applicant with the disapproval notice.
    2. 6.4.3.2.2 The applicant will have 30 days from the receipt of the disapproval notice in which to respond to the Division with plans to correct the deficiencies.
    3. 6.4.3.2.3 After review of an acceptable plan, the Division will conduct a re-inspection consistent with an agreed upon time frame.
    4. 6.4.3.2.4 If the Division is satisfied with the results of the re-inspection, a certificate of designation will be issued.
    5. 6.4.3.2.5 If the deficiencies still exist, the Division will give the applicant a written notice of disapproval that shall identify the deficiencies.
    6. 6.4.3.2.6 The applicant shall have 30 days from receipt of the second written notice in which to appeal the decision to the Secretary of the Department of Health and Social Services or the Secretary’s designee.
4. 6.4.4 Before accepting a designation, the organization shall notify the Division of Public Health in writing of any changes in the information submitted in the application regarding:
  1. 6.4.4.1 The ambulances;
  2. 6.4.4.2 Personnel;
  3. 6.4.4.3 Ownership; or
  4. 6.4.4.4 Any other material in the application.
6.5 Designation Term
1. 6.5.1 Designation as a Delaware ALS-ITO is valid for a term of 3 years.
2. 6.5.2 The designation expires at midnight of the expiration date.
3. 6.5.3 A revoked or surrendered designation certificate expires immediately upon notification.
4. 6.5.4 All ALS-IFT services must cease and desist at the time the designation expires.
6.6 Designation transfer
1. 6.6.1 ALS-ITO designation may not be transferred without the written approval of the Division of Public Health.
2. 6.6.2 The owner or owners of a designated ALS-ITO wishing to transfer or acquire the assets or stocks of another company may submit a letter of intent for the purposes of transferring the organization and designation to the successor organization.
6.7 Merger/Acquisition. A prospective purchaser of the stock or assets of an organization, with the written permission of the current ownership may apply to the Division of Public Health for a preliminary determination of the eligibility of the prospective purchaser to receive ALS-ITO designation under Section 6.0 of this regulation.
6.8 Sale/Cessation of Operations
1. 6.8.1 An ALS-ITO sold without a transfer of designation shall cease ALS operations at midnight of the day before ownership is transferred.
2. 6.8.2 An organization ceasing operations shall return the ALS-ITO designation certificate to the Division of Public Health within 14 days of the cessation date.

7.0 Re-designation – Review Process

7.1 The organization shall submit the application postmarked no later than 60 days before the certificate expiration date.
7.2 The organization will complete an application with a cover letter identifying any changes from the previous review.
7.3 The criteria for designation renewal are the same as for original designation.

8.0 Inspection Surveys

8.1 The Division of Public Health, or a duly appointed representative, reserves the right to enter and make inspections at least quarterly and shall conduct, at a minimum, an annual inspection survey to ensure compliance with this regulation. Additional inspections may be conducted upon complaint or a reasonable belief that violations may exist.
8.2 Survey visits may be made to any location used or occupied by the organization during regular business hours, or at other times when there is a reasonable belief that violations of this regulation may exist.
1. 8.2.1 Upon request of an authorized agent of the Division of Public Health, the designated organization shall produce for inspection:
  1. 8.2.1.1 The ambulances used for ALS-IFT;
  2. 8.2.1.2 Equipment;
  3. 8.2.1.3 Personnel;
  4. 8.2.1.4 Records required by this regulation; and
  5. 8.2.1.5 Any other items as determined by the agent.
2. 8.2.2 Authorized representatives of the Division of Public Health may survey an ambulance used for ALS-IFT whenever it is in service.
8.3 Survey visits shall, at the discretion of an authorized representative of the Division of Public Health, include:
1. 8.3.1 A review of all required records.
2. 8.3.2 Conferences with the staff.
3. 8.3.3 Audit of business locations, vehicles, equipment, and qualifications of staff.
8.4 The ALS-ITO shall be notified in writing of the results of the inspection.

9.0 Organization Requirements

9.1 Statutory/Regulatory Compliance.The organization must comply with the requirements of this regulation, as well as associated federal, state, and local statutes and regulations.
9.2 Medical Director
1. 9.2.1 The organization shall retain the services of a Delaware licensed physician who agrees to assume the physician responsibilities for the organization and providers as defined in16Del.C.§9806(b) and will comply with this regulation.
2. 9.2.2 The role and responsibilities of the medical director include:
  1. 9.2.2.1 Provide medical oversight and quality control of interfacility advanced life support.
  2. 9.2.2.2 Establish and ensure compliance with standing orders and treatment protocols.
  3. 9.2.2.3 Provide review and evaluate the medical interventions of the paramedics.
  4. 9.2.2.4 Monitor the EMS providers for skill degradation and recommend appropriate remedies to the provider organization.
  5. 9.2.2.5 Offer technical assistance to the EMS providers they serve as medical director.
  6. 9.2.2.6 Oversee the training and certification of the ALS providers.
  7. 9.2.2.7 Determine policy guiding transport priority classifications (i.e. emergency vs. non-emergency response and transportation determinants).
  8. 9.2.2.8 Investigate issues related to clinical proficiency.
  9. 9.2.2.9 Serve as a liaison with the State EMS Medical Director’s Office.
9.3 Air Medical Service. A non-exempt organization that will be providing air medical ALS-IFT must comply with the requirements of the OEMS Regulation for Air Medical Ambulance Services (16DE Admin. Code4302) in addition to this regulation.
9.4 Provider Certification. All EMS providers must meet State of Delaware certification requirements. Refer to16Del.C.§9809(a)and 24Del.C.§1700.
1. 9.4.1 Paramedic certification includes the following credentials:
  1. 9.4.1.1 NREMT-P;
  2. 9.4.1.2 BCLS;
  3. 9.4.1.3 ACLS;
  4. 9.4.1.4 PALS;
  5. 9.4.1.5 Prehospital Trauma Life Support, Basic Trauma Life Support; and
  6. 9.4.1.6 Emergency Vehicle Operator (EVO) (or equivalent as determined by the State Fire Prevention Commission). Flight crews are exempt (from the EVO requirement).
2. 9.4.2 Emergency Medical certification includes the following credentials:
  1. 9.4.2.1 Possession of a current State of Delaware EMT certification card;
  2. 9.4.2.2 Possession of a National Registry EMT certification card; and
  3. 9.4.2.3 Possession of an approved Healthcare CPR and AED card.
9.5 Ambulances
1. 9.5.1 The Delaware State Fire Prevention Commission must permit each transport ambulance for use in the State of Delaware.
2. 9.5.2 Units that are used exclusively for advanced life support services may be marked "Advanced Life Support".
  1. 9.5.2.1 This marking is not required.
  2. 9.5.2.2 Units that are used for basic level transportation as well as advanced life support transportation services may not be marked as above.
  3. 9.5.2.3 If marked, all markings must be 3-inch (minimum) reflective lettering.
3. 9.5.3 In instances of vehicular conditions that may precipitate or aggravate a medical condition or create a potential hazard to public health, the vehicle may not be driven with passengers or patients on board until repairs are completed. These conditions include:
  1. 9.5.3.1 Carbon monoxide hazards.
    1. 9.5.3.1.1 An occupant complains of symptoms or has been affected by carbon monoxide as a result of riding in the ambulance.
    2. 9.5.3.1.2 Carbon monoxide levels that have been detected at a level of 9ppm in the interior of the ambulance.
    3. 9.5.3.1.3 A mechanical condition exists that may present a carbon monoxide hazard to the occupants.
  2. 9.5.3.2 Specific mechanical defects or hazards including:
    1. 9.5.3.2.1 Faulty brakes;
    2. 9.5.3.2.2 Tire wear; or
    3. 9.5.3.2.3 Any other mechanical condition that may pose a threat, direct or indirect, to public health.
4. 9.5.4 Equipment Requirements
  1. 9.5.4.1 The following equipment must be carried aboard each ambulance used for ALS interfacility transportation:
    1. 9.5.4.1.1 All equipment required by the Delaware State Fire Prevention Commission. Refer to DSFPC710 Ambulance Service Regulations, Appendix A (1DE Admin. Code710, Appendix A).
    2. 9.5.4.1.2 All equipment needed to provide all care under the protocols of the Delaware ALS Standing. Refer to the current Paramedic Standing Orders, Guidelines, and Policies.
    3. 9.5.4.1.3 All medications listed in the Delaware Paramedic Formulary and those included in the standing orders as an ‘Optional Skill’ (See Section 13.0 of this regulation.).
  2. 9.5.4.2 Equipment must be stowed or secured in a manner as to prevent it from becoming injury-producing projectiles in the event of a crash.
9.6 Security of Narcotics and other Controlled Substances
1. 9.6.1 All medications falling under Schedule II, III, and IV of Title 21 United States Code (USC) Controlled Substances Act that are stored or carried on board the unit must be secured under double lock with the exceptions:
  1. 9.6.1.1 Medications brought on board an ambulance by medical facility personnel for possible use during a transport must be secured according to the policies of that facility and may not be stored aboard the unit after the facility personnel are returned to the medical facility and have separated themselves from the transport team.
  2. 9.6.1.2 Medications carried on the charge provider’s person do not require double lock security.
2. 9.6.2 Keys to access the secured medications must always be in the possession of the charge clinical provider, or the responsible person, on the ambulance.
9.7 Data Reporting
1. 9.7.1 The following data must be reported to the Division of Public Health on a continuous basis:
  1. 9.7.1.1 Clinical
    1. 9.7.1.1.1 All paramedic activity related to a patient contact must be reported through the currently used Delaware Electronic Patient Care Reporting system (EPCR) Refer to16Del.C.§9705(k).
    2. 9.7.1.1.2 In the event that EPCR is out of service, all records will be maintained in paper form using the Delaware Paramedic Report until EPCR is available again.
    3. 9.7.1.1.3 It is the provider’s responsibility to enter the paper records into EPCR at such time that the system is available.
  2. 9.7.1.2 Volume. An EPCR Interfacility Report shall be completed for each transport performed by the ALS-ITO.
  3. 9.7.1.3 Any data as requested by the Division of Public Health for the purposes of system quality management or system performance evaluation.
2. 9.7.2 Data pertaining to the operation, or portion of the operation, related to ALS interfacility transportation must be reported to the Division of Public Health on a quarterly basis, within 30 days of the end of the quarter. The Division of Public Health will use these data for the purposes of monitoring the transportation services as required in16Del.C.§9705(d)as well as provide them to the Delaware EMS Oversight Council for the purposes of determining the overall statewide EMS system performance as required by16Del.C.§9703(e). Any data as requested by the Division of Public Health for the purposes of system quality management or system performance evaluation.
9.8 Records/Documentation.The following records, or a copy, must be maintained at the Delaware operations office for all providers participating in the organization’s ALS-IFT operation.
1. 9.8.1 Personnel
  1. 9.8.1.1 The organization shall maintain a current list of the following employed personnel:
    1. 9.8.1.1.1 EMS providers;
    2. 9.8.1.1.2 Registered nurses; and
    3. 9.8.1.1.3 Any other medical personnel .
  2. 9.8.1.2 The list shall include the employee’s full name, certification number, level, date of issue, and date of expiration.
2. 9.8.2 Training
  1. 9.8.2.1 Training records for each employee shall contain evidence of:
    1. 9.8.2.1.1 Initial orientation and competency assessment;
    2. 9.8.2.1.2 Continuing education; and
    3. 9.8.2.1.3 All other training required as part of this regulation.
  2. 9.8.2.2 Training records should be maintained to document the date training was provided, course outline, attendance, instructor’s name, and qualifications.
3. 9.8.3 Continuing Education. Credit for continuing education programs must be applied for through the OEMS prior to the course being held as per the OEMS Education policy.
4. 9.8.4 Records retention
  1. 9.8.4.1 All records pertaining to the operation of the ALS-ITO must be retained for a minimum period of 7 years.
  2. 9.8.4.2 Medical records documenting patient care provided by the organization (i.e. patient care reports) must be retained for a minimum of 7 years.
9.9 Insurance coverage
1. 9.9.1 An ALS-ITO may not be designated to provide service in Delaware unless it maintains continuous insurance of the following types and amounts:
  1. 9.9.1.1 General liability insurance of not less than $1 million; Refer to DSFPC 710 Ambulance Service Regulations, Section 9.0 (1DE Admin. Code710, §9.0).
  2. 9.9.1.2 Motor vehicle liability insurance coverage not less than $1 million individual and $3 million aggregate per occurrence Refer to DSFPC 710 Ambulance Service Regulations, Section 9.0 (1DE Admin. Code710, §9.0).
  3. 9.9.1.3 Worker Compensation coverage in the amount required by19Del.C.§2306.
2. 9.9.2 The general liability coverage must provide payment of damages as a result of:
  1. 9.9.2.1 Any bodily injury to, or death of, individuals in accidents resulting from any cause which the ALS-ITO is liable; and
  2. 9.9.2.2 Property damage, or loss of property, including personal property resulting from any cause for which the organization is liable.
3. 9.9.3 The financial responsibility requirements for motor vehicle liability coverage shall conform to21Del.C.§2901.
4. 9.9.4 The financial responsibility for the worker’s compensation insurance shall comply with19Del.C.§§2321-2334.

10.0 Operations

10.1 Designation
1. 10.1.1 An agency must be designated as an ALS interfacility transportation organization by the Delaware Department of Health and Social Services, Division of Public Health to:
  1. 10.1.1.1 Provide ALS services during any medical transport originating in Delaware.
  2. 10.1.1.2 Advertise as a Delaware advanced life support organization in compliance with16Del.C.§9809(c).
    1. 10.1.1.2.1 All advertisements and invoices shall contain the legal name and the phrase "A Designated Delaware ALS Interfacility Transportation Organization".
      1. 10.1.1.2.1.1 Advertisements may also include the words "advanced life support".
      2. 10.1.1.2.1.2 An ALS-ITO utilizing paramedics shall not include the words "Paramedics" or "Paramedic Service" on any of their advertisements.
    2. 10.1.1.2.2 Advertisements include business cards, letterhead, newsletters, brochures, flyers, etc.
10.2 Scope of Services
1. 10.2.1 ALS interfacility transportation is defined as the medically necessary transportation of a patient requiring the provision of medical care that exceeds the scope of practice of an EMT-Basic that originates at a Delaware medical facility with a destination at another medical facility.
2. 10.2.2 Operations as an ALS interfacility transportation organization are limited to ‘non-911’ emergency and non-emergency transports with the following exceptions:
  1. 10.2.2.1 As a component of a disaster plan.
  2. 10.2.2.2 As part of a ‘mutual aid’ agreement approved by the OEMS.
    1. 10.2.2.2.1 The agreement must specifically address:
      1. 10.2.2.2.1.1 Remuneration for services rendered; and
      2. 10.2.2.2.1.2 Response time performance.
  3. 10.2.2.3 At an incident where the ALS-IFT unit coincidentally arrived before the jurisdiction 911 organization.
3. 10.2.3 In instances where the crew of an uncommitted ALS-ITO ambulance chooses to render care at a ‘911’ incident before the jurisdictional ‘911’ ALS agency is present on scene, the following procedures shall apply:
  1. 10.2.3.1 The ALS-ITO unit shall immediately contact the jurisdictional PSAP and report the nature and location of the incident.
  2. 10.2.3.2 The ALS-ITO personnel shall provide medical care within their scope of practice to any persons in need of it until a jurisdictional EMS unit arrives at the scene.
  3. 10.2.3.3 Patient care responsibilities and scene control shall be deferred to the jurisdictional authorities as they arrive or as they request.
  4. 10.2.3.4 The ALS-ITO unit may, but will not be required to, provide transportation services if a request is made by the incident commander and this request is approved by a representative of the jurisdictional ALS agency. The responsibility for providing the service remains with the jurisdictional ALS agency until it is accepted by the ALS-ITO.
  5. 10.2.3.5 Documentation of the patient contact must be completed using the appropriate EPCR form at the time of transfer to the receiving medical facility.
4. 10.2.4 A 911-ALS organization or PSAP may not direct emergency calls to an ALS-ITO unless a mutual aid agreement, approved by the OEMS, exists between the jurisdictional 911 ALS service and the ALS-ITO.
  1. 10.2.4.1 The agreement must specifically address:
    1. 10.2.4.1.1 Remuneration for services rendered; and
    2. 10.2.4.1.2 Response time performance requirements.
10.3 Standing Orders
1. 10.3.1 Use. The scope of practice for paramedics providing ALS interfacility transportation services is defined by the Delaware Paramedic Standing Orders. The State EMS Medical Director and the BMLD must approve any changes to the paramedic scope of practice (Refer to Section 13.0 of this regulation.).
2. 10.3.2 Protocol Variances
  1. 10.3.2.1 If a paramedic performs a function that is outside of the scope of practice as defined by the Delaware Paramedic Standing Orders, the following activity must occur:
    1. 10.3.2.1.1 The organization medical director must be notified of the violation immediately.
    2. 10.3.2.1.2 The paramedic must submit a written report of the incident to the organization medical director within 24 hours of the incident.
    3. 10.3.2.1.3 The organization medical director shall notify the State Medical Director’s Office of all incidents of potential protocol violations within 5 working days of receiving the incident report.
  2. 10.3.2.2 The organization medical director or the company shall investigate the incident and provide a written report of the investigation and its conclusions to the State EMS Medical Director through the organization medical director within 14 calendar days of the incident.
  3. 10.3.2.3 The State EMS Medical Director will review the incident based on the reports and issue a recommendation for action if appropriate.
    1. 10.3.2.3.1 The State EMS Medical Director reserves the right to initiate an independent investigation.
    2. 10.3.2.3.2 The State EMS Medical Director may immediately suspend the paramedic’s certification for a period of 30 days to prevent a clear and imminent danger to public health. Refer to16Del.C.§9806(7).
  4. 10.3.2.4 A review may also be initiated by a written complaint to the Division of Public Health – Office of Emergency Medical Services.
10.4 Crew Configuration
1. 10.4.1 The crew shall consist of at least 2 providers.
  1. 10.4.1.1 At least 1 provider must be a certified Delaware paramedic.
  2. 10.4.1.2 The other provider must at least be a Delaware EMT-B. The EMT-B may not function as a primary care provider.
2. 10.4.2 An ALS-ITO may not transport patients requiring care that is beyond the scope of practice of a Delaware paramedic unless the patient is accompanied by a healthcare provider authorized under Delaware law to provide the required level of care in compliance with federal medical transport/transfer regulations.
10.5 Personnel Identification
1. 10.5.1 All personnel shall display identification that includes their photograph, last name, and position/certification level.
2. 10.5.2 All EMTs and paramedics must always carry a Delaware-issued certification card while on duty.
3. 10.5.3 Identification must be visible on the front of the outermost garment.
4. 10.5.4 All personnel shall only display insignia for valid certification and personal identification.
5. 10.5.5 Agencies shall provide assurance that their personnel do not wear or display identification that suggests affiliation with another agency, service, organization, department, or company other than the ALS-ITO or a healthcare facility that is involved in the patient’s care.
10.6 Ambulance Operation
1. 10.6.1 Ambulances are to be operated in accordance with21Del.C.§4106by licensed operators possessing a Delaware emergency vehicle operator (EVO) card or an equivalent as determined by the Delaware State Fire Prevention Commission. DSFPC 710 Ambulance Service Regulations, subsection 7.2 (1DE Admin. Code710, subsection 7.2).
2. 10.6.2 Lights and sirens are to be used by ALS-IFT vehicles only in the following situations:
  1. 10.6.2.1 Enroute to an emergency call as determined and documented by the transferring physician.
  2. 10.6.2.2 Transporting a Priority 1 patient as determined and documented by the transferring physician.
  3. 10.6.2.3 Transporting a patient meeting the criteria determined by the organization medical director as requiring emergency transportation.
10.7 Medical Control/Authority. The transferring physician is responsible for providing medical control for the patient transfer until the patient reaches the destination facility.

11.0 Designation Review

11.1 Purpose. To provide a mechanism to identify conditions that may affect public health and protect public health until the problems are resolved.
11.2 Cause. The Division of Public Health may, in compliance with proper administrative procedures as provided by the law, suspend, revoke, or refuse to issue designation certificates for any of the following reasons:
1. 11.2.1 A serious violation of this regulation. (Defined as one that poses a significant threat to the health and safety of the public.)
2. 11.2.2 Revocation of permit as a BLS Ambulance Service by the Delaware State Fire Prevention Commission. Refer to DSFPC 710 Ambulance Service Regulations, Section 11.0 (1DE Admin. Code710, Section 11.0).
3. 11.2.3 Failure to submit a reasonable timetable to correct deficiencies and violations cited by the Division.
4. 11.2.4 The existence of a continuing pattern of deficiencies.
5. 11.2.5 Fraud or deceit in obtaining or attempting to obtain certification.
6. 11.2.6 Lending a certificate or borrowing or using the certificate of another, or knowingly aiding or abetting the improper granting of a certificate.
7. 11.2.7 Incompetence, negligence, or misconduct in operating or providing ALS interfacility transportation services. This includes patterns such as a failure to follow medical command or a failure to respond to a transport request.
8. 11.2.8 Failure to employ or contract for a medical director responsible for services as outlined in this regulation.
9. 11.2.9 Failure to have appropriate medical equipment and supplies required for certification.
10. 11.2.10 Failure of the ALS interfacility transportation organization to notify the Division of Public Health of a change of ownership.
11. 11.2.11 Abuse or abandonment of a patient.
12. 11.2.12 Unauthorized disclosure of medical or other confidential material.
13. 11.2.13 Willful preparation or filing of false medical reports or records, or the inducement of another to do so.
14. 11.2.14 Destruction of medical records.
15. 11.2.15 Failure to provide data to the Division of Public Health as required through EPCR.
16. 11.2.16 Refusal to render services based on a patient’s race, color, creed, gender or sexual orientation, nationality, age, or disability.
17. 11.2.17 Misuse or misappropriation of drugs/medications.
18. 11.2.18 Failure to produce requested records for inspection or to permit the examination of equipment shall be grounds for suspension or revocation or the denial of certification. However, the certificate shall not be suspended, revoked, or denied for a period of longer than 60 days if a dispute regarding the production of these records exists and remains unresolved. The suspension, revocation, or denial may occur for the entire 60-day period if the Division determines that such action is necessary to prevent a clear and immediate danger to public health.
19. 11.2.19 Conviction of the organization or the owner or owners of a crime, including Medicare or Medicaid fraud, relating adversely to theowner’s or owners’ capability of owning or operating the organization.
20. 11.2.20 Non-compliance with the Consolidated Omnibus Reconciliation Act (COBRA) and the Emergency Medical Treatment and Active Labor Act (EMTALA).
21. 11.2.21 Other reasons as determined by the Division which pose a significant threat to public health and safety.
11.3 Initiation. The designation review process can be initiated by:
1. 11.3.1 A written or verbal complaint indicating a violation of this regulation.
2. 11.3.2 Failure to participate in data reporting.
3. 11.3.3 Failure to correct deficiencies identified by the Division of Public Health.
11.4 Investigation. Upon initiation of the designation review process, the Division of Public Health will:
1. 11.4.1 Receive written notification of the violation from the identifying agent accompanied by supporting documentation.
2. 11.4.2 Convene an investigation panel, which will consist of the OEMS Paramedic Administrator, the State EMS Medical Director, and any other subject matter expert deemed appropriate.
3. 11.4.3 Initiate an investigation, led by the panel, of the allegation or allegations.
  1. 11.4.3.1 The ALS interfacility transportation organization will be notified in writing with a request for its written response.
  2. 11.4.3.2 The investigation panel will conduct an appropriate follow-up investigation.
4. 11.4.4 Submit the investigation panel’s report and recommendation to the Director of the Division of Public Health.
  1. 11.4.4.1 Panel Recommendations. The panel may recommend any of the following actions:
    1. 11.4.4.1.1 Designation Probation.
      1. 11.4.4.1.1.1 The investigation panel will determine the recommended length of probation and include recommended conditions that must be met by the end of the probationary period.
      2. 11.4.4.1.1.2 If adopted by the Division Director, these conditions will be verified by a representative of the Division of Public Health at the end of the probationary period or at an earlier time as requested in writing by the organization. The Division of Public Health will confirm reinstatement in writing before operations may resume.
      3. 11.4.4.1.1.3 Additional infractions occurring during the probation period will result in an immediate review for designation suspension by the Division of Public Health.
      4. 11.4.4.1.1.4 Failure to meet the conditions will result in a review for designation suspension by the Division of Public Health.
    2. 11.4.4.1.2 Designation Suspension
      1. 11.4.4.1.2.1 The investigation panel will recommend the length of suspension and any conditions to be met for reinstatement.
      2. 11.4.4.1.2.2 If adopted by the Division Director, the organization may not provide ALS services in Delaware for the duration of the suspension.
        11.4.4.1.2.2.1 A representative of the Division of Public Health must verify that any conditions for reinstatement have been met before ALS services may be resumed.
        11.4.4.1.2.2.2 The Division of Public Health will confirm reinstatement in writing before operations may resume.
    3. 11.4.4.1.3 Designation Revocation
      1. 11.4.4.1.3.1 The investigation panel will recommend revocation and any conditions to be met before the organization may reapply for designation.
      2. 11.4.4.1.3.2 If adopted by the Division Director, the organization may not provide ALS services in Delaware and may not re-apply for ALS-ITO designation for a period of not less than 1 year from the date of revocation. The Division of Public Health will verify that any conditions have been met as part of the re-application process.
    4. 11.4.4.1.3 If probation, suspension, or revocation is not recommended, the investigation panel may recommend follow up monitoring or reporting.
  2. 11.4.1.5 The Division Director will provide written notification to the ALS interfacility transportation organization of the results of the investigation and the disposition of the organization’s designation.
  3. 11.4.1.6 The involved organization will have the right to contest any decision of the Division of Public Health. Written notification of the intent to contest must be made to the Director of the Division of Public Health within 30 days of notification of action.
    1. 11.4.1.6.1 The Division Director shall offer a public hearing to review the decision in accordance with 29Del.C.101.
    2. 11.4.1.6.2 The Division Director shall name a hearing officer and schedule a hearing in accordance with 29Del.C.101.
11.5 Appeals. The involved organization will have the right to appeal any decision of the Director of the Division of Public Health. Written notification of the intent to appeal must be made to the Secretary of the Department of Health and Social Services within 30 days of notification of action.

12.0 Certification Review

12.1 Initiation
1. 12.1.1 The organization medical director may initiate a review of medical performance based on a variance, complaint, or EPCRreview.
2. 12.1.2 The Division of Public Health may also initiate a review based on a variance, complaint, or an EPCR review.
12.2 Investigation
1. 12.2.1 The organization medical director performs the initial investigation and shall remove the paramedic from patient care status pending a review of the incident by the State EMS Medical Director’s Office.
2. 12.2.2 Findings of this investigation will be forwarded to the State EMS Medical Director’s Office within 10 working days of completion of the investigation. The State EMS Medical Director has the authority to suspend the paramedic’s certification for up to 30 days to prevent a clear and imminent danger to public health. Refer to16Del.C.§9806(7).
3. 12.2.3 The State EMS Medical Director will review the incident and forward findings and recommendations to the BMLD. Refer to16Del.C.§9812. Issues concerning nursing performance will be addressed by the State EMS Medical Director with the organization’s clinical nursing supervisor and the Board of Nursing.
4. 12.2.4 The BMLD will review the incident and determine appropriate action.

13.0 Scope of Practice Expansion

13.1 Purpose. The environment and the needs of patients who are moving within the health care system are different from those of patients who are being transported into the healthcare system. This section provides a mechanism for expanding the scope of practice of paramedics functioning in the interfacility transportation component of the EMS system to meet these needs.
13.2 Limitations
1. 13.2.1 Optional skills that are approved for use in ‘non-911’ transport services may be used only in ‘non-911’ transports.
2. 13.2.2 At no time may optional skills be used during ‘911’ transports without BMLD approval.
13.3 Review
1. 13.3.1 Proposal. A proposal of the new protocol shall be submitted to the State EMS Medical Director’s Office from the organization’s medical director. The proposal shall include a description of the skill, procedure, or medication, a description of the need and any supporting documentation, the training that will be required and the credentials of the person or agency that will providing it, and the methods that will be used to evaluate proficiency.
2. 13.3.2 Protocol Review Process
  1. 13.3.2.1 The State EMS Medical Director will review the proposal and have the option of setting up a meeting with the writer to discuss the proposal.
  2. 13.3.2.2 If the proposal is denied, the State EMS Medical Director will notify the organization of the denial in writing with the reasons for denial or,
  3. 13.3.2.3 The State EMS Medical Director will attach a recommendation to the denial and forward the request to the BMLD.
  4. 13.3.2.4 The BMLD will review the proposal and determine whether the proposed skill, procedure, or medication will be added to the Delaware Paramedic Standing Orders as an ‘Optional ALS Skill’.

14.0 ‘Optional Skills’

14.1 Skills that have been designated as "optional" may be used by paramedics employed by an ALS-ITO that has been approved by the State EMS Medical Director to use the skill, procedure, or medication.
14.2 The organization medical director must supply the following information to the State EMS Medical Director before the paramedics employed by the ALS-ITO may function under the expanded Delaware Paramedic Standing Orders:
1. 14.2.1 A list of the trained providers.
2. 14.2.2 Documentation of the initial training provided and skill verification.
3. 14.2.3 A schedule for annual continuing education on the optional skill.
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29 DE Reg. 218 (09/01/25)

4 DE Reg. 1525 (03/01/01)

29 DE Reg. 218 (09/01/25)

4 DE Reg. 1525 (03/01/01)

29 DE Reg. 218 (09/01/25)

4 DE Reg. 1525 (03/01/01)

29 DE Reg. 218 (09/01/25)

4 DE Reg. 1525 (03/01/01)

29 DE Reg. 218 (09/01/25)

4 DE Reg. 1525 (03/01/01)

29 DE Reg. 218 (09/01/25)

4 DE Reg. 1525 (03/01/01)