16 Del. Admin. Code § 4301-6.0

Current through Register Vol. 28, No. 7, January 1, 2025
Section 4301-6.0 - Designation
6.1 Purpose

To qualify an organization to provide Advanced Life Support services in the State of Delaware under 16Del.C.§ 9809(b).

6.2 Eligibility

To be eligible to apply for ALS-ITO designation, an organization shall:

6.2.1 Be qualified to conduct business in the State of Delaware.
6.2.1.1 Evidenced by a Delaware business license, unless a non-profit corporation.
6.2.2 Possess a permit from the Delaware Fire Prevention Commission as either an Emergency or Non-Emergency BLS Ambulance Service. 1,2
6.2.3 Own or operate at least one ambulance that is certified by the Delaware State Fire Prevention Commission (DSFPC).
6.2.4 Employ drivers with a valid motor vehicle license.
6.2.5 Have insurance coverage as outlined in Section VIII - I of these regulations.
6.2.6 Have computer equipment and Internet access that is compatible for integration into the Delaware Emergency Data Information Network.
6.2.7 Apply for Designation.
6.3 Application

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.

6.3.1 Submit a completed application on the required form to the Division of Public Health.
6.3.2 A completed application will contain:
6.3.2.1 The Organization's:
6.3.2.1.1 Name
6.3.2.1.2 Main physical business address.
6.3.2.1.3 Billing address
6.3.2.1.4 Telephone number
6.3.2.1.5 Fax number
6.3.2.1.6 Name of the principal contact person for communication with the Division of Public Health.
6.3.2.1.7 Name of the principal contact person for daily operations.
6.3.2.1.8 Entity type
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.
6.3.2.3 All trade names that the organization, its parent, or subsidiary has done business under.
6.3.2.4 Information about management personnel and owners:
6.3.2.4.1 Names
6.3.2.4.2 Addresses
6.3.2.4.3 Telephone numbers
6.3.2.4.4 Titles
6.3.2.5 Street addresses of any locations from which the organization intends to operate, including:
6.3.2.5.1 Location from which units are dispatched.
6.3.2.5.2 Location where records are kept.
6.3.2.5.3 Location where crews are quartered.
6.3.2.5.4 Location where ambulances are parked or stored
6.3.2.6 Information about employees who may be providing health care:
6.3.2.6.1 Name
6.3.2.6.2 Documentation of the following certifications:
6.3.2.6.2.1 Delaware Paramedic certification, or Delaware EMT-B certification.
6.3.2.6.2.2 BCLS
6.3.2.6.2.3 Delaware Emergency Vehicle Operator card or equivalent as approved by the Delaware Fire Prevention Commission.3
6.3.2.6.2.4 Motor vehicle license
6.3.2.6.3 Non-Delaware certified providers must receive reciprocity before they may function in Delaware4,5.
6.3.2.7 Information about the Organization Medical Director
6.3.2.7.1 Name
6.3.2.7.2 Address
6.3.2.7.3 Telephone number
6.3.2.7.4 E-mail address
6.3.2.7.5 Evidence of Credentials
6.3.2.7.5.1 Delaware medical license.
6.3.2.7.5.2 Board certification in an appropriate specialty approved by the State Medical Director.
6.3.2.7.6 A description of their role, responsibilities, and authority within the Organization.
6.3.2.8 Information about the ambulances
6.3.2.7.1 A list of the units that will be utilized for ALS-IFT with tag, VIN, and unit designation.
6.3.2.7.2 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.
6.3.2.7.3 A diagram of the numbering, lettering, and symbols that will be displayed on the units.
6.3.2.9 A copy of the operational policies of the organization. These should include but are not limited to policies governing responses, transport practices, security of Controlled Dangerous Substances (CDS), and training.
6.3.2.10 Insurance Information
6.3.2.10.1 A certificate of liability insurance that verifies that coverage that complies with Section VIII - I is in effect and lists:

The Division of Public Health-Office

of Emergency Medical Services

Blue Hen Corporate Center

Suite 4H

655 Bay Rd.

Dover DE 19901

as a party entitled to notification ten days prior to any of the following changes to the insurance policies required by regulation:

6.3.2.10.1.1 Non-renewal or cancellation
6.3.2.10.1.2 Changes in coverage or level of insurance.
6.3.2.10.2 A certificate of motor vehicle insurance that identifies by VIN all motor vehicles covered under the insurance policy.
6.3.2.11 A description of the Quality Management activities in the company or organization.
6.3.2.11.1 Include samples of reports describing activities related to:
6.3.2.11.1.1 Clinical performance
6.3.2.11.1.2 Operational performance
6.3.2.12 A signed written statement that:
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:
6.3.2.12.1.1 Falsify, conceal, or omit a material fact,
6.3.2.12.1.2 Make any false, fictitious, incomplete, or fraudulent statements or representations,
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.
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.
6.3.2.13 Any additional information that the Division of Public Health may consider necessary.
6.3.3 The application shall be signed by:
6.3.3.1 If a sole proprietorship, the owner,
6.3.3.2 If a partnership, a duly authorized partner,
6.3.3.3 If a corporation, a duly authorized corporate official,
6.3.3.4 If a limited liability company, a duly authorized member.
6.4 Review
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.
6.4.2 The Division of Public Health will review the application of the proposed ALS-ITO and conduct an on-site inspection and review to determine whether the applicant organization is in compliance with these regulations and other applicable laws.
6.4.2.1 The inspection/review may include any or all of the following:
6.4.2.1.1 Inspection of the supporting documents,
6.4.2.1.2 A survey to inspect the ambulance service facilities, vehicles, and/or equipment,
6.4.2.1.3 A conference with the applicant(s).
6.4.3 The applicant will be notified of the status of their application by certified letter.
6.4.3.1 Approval
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.
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.
6.4.3.2 Denial
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.
6.4.3.2.2 The applicant will have thirty (30) days from the receipt of the disapproval notice in which to respond to the Division with plans to correct the deficiencies.
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.
6.4.3.2.4 If the Division is satisfied with the results of the re-inspection, a certificate of Designation will be issued.
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.
6.4.3.2.6 The applicant shall have thirty (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 his/her designee.
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:
6.4.4.1 The ambulances
6.4.4.2 Personnel
6.4.4.3 Ownership
6.4.4.4 Any other material in the application.
6.5 Designation Term
6.5.1 Designation as a Delaware ALS-ITO is valid for a term of three years.
6.5.2 The Designation expires at midnight of the expiration date.
6.5.3 A revoked or surrendered designation certificate expires immediately upon notification.
6.5.4 All ALS-IFT services must cease and desist at the time Designation expires.
6.6 Designation transfer
6.6.1 ALS-ITO Designation may not be transferred without the written approval of the Division of Public Health.
6.6.2 The owner(s) 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 V.

6.8 Sale/Cessation of Operations
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.
6.8.2 An Organization ceasing operations shall return the ALS-ITO Designation certificate to the Division of Public Health within fourteen (14) days of the cessation date.

16 Del. Admin. Code § 4301-6.0

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