16 Del. Admin. Code § 4301-9.0

Current through Register Vol. 28, No. 7, January 1, 2025
Section 4301-9.0 - Organization Requirements
9.1 Statute / Regulatory Compliance

The Organization must comply with the requirements of all parts of this regulation and associated federal, state, and local statutes and regulations.

9.2 Medical Director
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 in 16Del.C.§ 9806(b) and will comply with all required areas of this regulation.
9.2.2 Role and Function - the role and responsibilities of the medical director include:
9.2.2.1 Provide medical oversight and quality control of interfacility advanced life support.
9.2.2.2 Establish and ensure compliance with standing orders and treatment protocols.
9.2.2.3 Provide review and evaluate the medical interventions of the paramedics.
9.2.2.4 Monitor the EMS providers for skill degradation and recommend appropriate remedies to the provider organization.
9.2.2.5 Offer technical assistance to the EMS providers they serve as medical director.
9.2.2.6 Oversee the training and certification of the ALS providers.
9.2.2.7 Determine policy guiding transport priority classifications (i.e. emergency vs. non-emergency response and transportation determinants).
9.2.2.8 Investigate issues related to clinical proficiency.
9.2.2.9 Serve as a liaison with the State 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 in addition to the ALS Interfacility Transport Regulations.

9.4 Provider Certification

All EMS providers must be certified to function in Delaware.6 The following are requirements for certification in Delaware. 7

9.4.1 Paramedic
9.4.1.1 NREMT-P, BCLS, ACLS, PALS, PHTLS/ BTLS, and Emergency Vehicle Operator (or equivalent as determined by the State Fire Prevention Commission).
9.4.1.1.1 Flight crews are excepted from the EVO requirement.
9.4.2 Emergency Medical Technician
9.4.2.1 NREMT-B (or Delaware EMT-B), BCLS, and Emergency Vehicle Operator (or equivalent as determined by the State Fire Prevention Commission).
9.5 Ambulances
9.5.1 The Delaware State Fire Prevention Commission must permit each transport ambulance for use in the State of Delaware.
9.5.2 Units that are used exclusively for advanced life support services may be marked "Advanced Life Support", "Critical Care Transport", or "Mobile Intensive Care" to describe the level of service provided.
9.5.2.1 This marking is not required.
9.5.2.2 Units that are used for Basic Level Transportation as well as Advanced Life Support Transport services may not be marked as above.
9.5.2.3 If marked, all markings must be 3-in. (minimum) reflective lettering.
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 but are not limited to:
9.5.3.1 Carbon monoxide hazards
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.
9.5.3.1.2 Carbon monoxide levels that have been detected at a level of 9ppm in the interior of the ambulance.
9.5.3.1.3 A mechanical condition exists that may present a carbon monoxide hazard to the occupants.
9.5.3.2 Specific mechanical defects or hazards including:
9.5.3.2.1 Faulty brakes
9.5.3.2.2 Tire wear
9.5.3.2.3 Any other mechanical condition that may pose a threat, direct or indirect, to public health.
9.5.4 Equipment Requirements
9.5.4.1 The following equipment must be carried aboard each ambulance used for ALS Interfacility Transport.
9.5.4.1.1 All equipment required by the Delaware State Fire Prevention Commission.8
9.5.4.1.2 All equipment needed to provide any and all care under the protocols of the Delaware ALS Standing Orders9.
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 XIII).
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 Dangerous Substances
9.6.1 All medications falling under Schedule II, III, and IV of the Controlled Dangerous Substance Act of 1970 that are stored or carried on board the unit must be secured under double lock with the exceptions:
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.
9.6.1.2 Medications carried on the charge provider's person do not require double lock security.
9.6.2 Keys to access the secured medications must be in the possession of the charge clinical provider, or the responsible person, on the ambulance at all times.
9.7 Data Reporting
9.7.1 The following data must be reported to the Division of Public Health on a continuous basis.
9.7.1.1 Clinical
9.7.1.1.1 All Paramedic activity related to a patient contact must be reported through the Delaware Emergency Data Information Network (EDIN)10.
9.7.1.1.2 In the event that EDIN is out of service, all records will be maintained in paper form using the Delaware Paramedic Report until EDIN is available again. The paper records will be entered into EDIN at such time that the system is available.
9.7.1.2 Volume
9.7.1.2.1 An EDIN Interfacility Report shall be completed for each transport performed by the ALS-ITO.
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.
9.7.2 The following 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 thirty (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 in 16Del.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 by 16Del.C.§ 9703(e).
9.7.2.1 Fiscal
9.7.2.1.1 Cost per unit hour
9.7.2.2 Operational
9.7.2.2.1 Unit hour production
9.7.2.2.2 Transport volume
9.7.2.3 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.

9.8.1 Personnel
9.8.1.1 The Organization shall maintain a current list of the following personnel: EMS providers, registered nurses, any other medical personnel employed.
9.8.1.2 The list shall include the employee's full name, certification number, level, date of issue, and date of expiration.
9.8.2 Training
9.8.2.1 Training records for each employee shall contain evidence of:
9.8.2.1.1 Initial orientation and competency assessment,
9.8.2.1.2 Continuing education, and
9.8.2.1.3 All other training required as part of this regulation.
9.8.2.2 Training records should be maintained to document the date training was provided, course outline, attendance, instructor's name and qualifications.
9.8.3 Continuing Education
9.8.3.1 Credit for continuing education programs must be applied for through the OEMS prior to the course being held as per the OEMS Education policy.
9.8.4 Records retention
9.8.4.1 All records pertaining to the operation of the ALS-ITO must be retained for a minimum period of two (2) years.
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 seven (7) years.
9.9 Insurance coverage
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:
9.9.1.1 General liability insurance of not less than $1 million.11
9.9.1.2 Motor vehicle liability insurance coverage not less than $1 million individual and $3 million aggregate per occurrence.12
9.9.1.3 Worker Compensation coverage in the amount required by 19Del.C.§ 2306.
9.9.2 The general liability coverage must provide payment of damages as a result of:
9.9.2.1 Any bodily injury to, death of, individuals in accidents resulting from any cause which the ALS-ITO is liable,
9.9.2.2 Property damage, or loss of property, including personal property resulting from any cause for which the Organization is liable.
9.9.3 The financial responsibility requirements for motor vehicle liability coverage shall conform to 21Del.C.§ 2901.
9.9.4 The financial responsibility for the worker's compensation insurance shall comply with 19Del.C.§§ 2321 -2334.

16 Del. Admin. Code § 4301-9.0

4 DE Reg. 1525 (3/1/01)