16 Del. Admin. Code § 3340-3.0

Current through Register Vol. 28, No. 5, November 1, 2024

Section 3340-3.0 - Licensure Requirements and Procedures

3.1 General Requirements

3.1.1 No person shall establish, conduct or maintain in this State any FSED without first obtaining a license from the Department.

3.1.2 No FSED, treatment facility, office or station shall be authorized to exhibit any emergency trailblazing signs, symbols or directional signs by the Delaware Department of Transportation unless such facility has been duly licensed under the provisions of these regulations.

3.1.3 A license is not transferable from person to person, entity to entity or from one location to another.

3.1.4 The license shall be posted in a conspicuous place on the licensed premises, at or near the entrance in a manner which is plainly visible and easily read by the public.

3.1.5 Separate licenses are required for FSEDs maintained in separate locations, even though operated under the same management.

3.1.6 Any FSED that undergoes a modification of ownership and control is required to re-apply as a new FSED and must meet the current design and construction standards recognized by the Department.

3.1.7 The submission of an application is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

3.1.8 Patients shall not be admitted to a FSED until a license has been issued.

3.1.9 The FSED shall advise the Department in writing at least 30 calendar days prior to closure of the FSED and voluntary surrender of a license.

3.2 Application Process

3.2.1 All persons or entities wanting to apply to open a FSED shall submit to the Department the following information:

3.2.1.1 A Statement of Intent describing the services to be offered at the FSED;

3.2.1.2 A completed application for licensure;

3.2.1.3 The names, addresses and types of facilities previously and currently owned or managed by the applicant;

3.2.1.4 Identity of:

3.2.1.4.1 Each officer and director of the corporation, if the entity is organized as a corporation;

3.2.1.4.2 Each general partner or managing member, if the entity is organized as an unincorporated entity;

3.2.1.4.3 The governing body; and

3.2.1.4.4 Any officers/directors, partners, or managing members, or members of a governing body who have a financial interest in a licensee's operation or related business.

3.2.1.5 Proof of not-for-profit status, if claiming tax-exempt status;

3.2.1.6 Disclosure of any officer, director, partner, employee, managing member or member of the governing body with a felony criminal record;

3.2.1.7 Name of the director and the person designated to act in the absence of the director;

3.2.1.8 A list of management personnel, including credentials;

3.2.1.9 A plan for providing orientation, continuing education, and training for personnel or independent contractors during the first year of operation;

3.2.1.10 Policy and procedure manuals; and

3.2.1.11 Any other information required by the Department.

3.3 Issuance of Licenses

3.3.1 Initial License

3.3.1.1 An initial license shall be granted for a period of three (3) calendar months to every FSED that completes the application process consistent with those regulations and whose policies and procedures demonstrate compliance with the rules and regulations pertaining to FSED licensure.

3.3.1.2 An initial license will permit a FSED to hire or contract with personnel and begin to offer services.

3.3.1.3 All FSED shall have an on-site survey, conducted by the Department, during the first three (3) calendar months of operation.

3.3.1.4 A FSED at the time of an initial on-site survey, must meet the definition of a free standing emergency department as contained within these regulations and must be in operation and caring for patients. Facilities that, at the time of the onsite survey, do not meet the definition of a FSED or that are not in substantial compliance with these regulations will not be granted an annual license.

3.3.1.5 An initial license may not be renewed.

3.3.2 Provisional License

3.3.2.1 A provisional license shall be granted, for a period of less than one year, to all FSEDs that:

3.3.2.1.1 Are not in substantial compliance with these rules and regulations; or

3.3.2.1.2 Fail to renew a license within the timeframe prescribed by these regulations.

3.3.2.2 Upon issuance of a provisional license, the Department shall designate the conditions and the time period in writing.

3.3.2.3 A provisional license may not be renewed unless a Plan of Correction for coming into substantial compliance with these rules and regulations has been approved by the Department and implemented by the FSED.

3.3.2.4 A license will not be granted after the provisional licensure period to any FSED that is not in substantial compliance with these rules and regulations.

3.3.3 Annual License

3.3.3.1 An annual license shall be effective for a twelve (12) month period following the date of issue and shall expire one year following such date, unless it is modified, suspended, revoked or surrendered prior to the expiration date.

3.3.3.2 All applications for renewal of licenses must be filed with the Department at least thirty (30) days prior to the expiration date of the license.

3.3.3.3 FSEDs which have not been inspected/surveyed during a licensure year may apply for, and be issued, a new license until an inspection/survey is completed.

3.3.3.4 An annual license may not be issued to a FSED which is not in substantial compliance with these regulations or whose deficient practices present an immediate threat to the health and safety of its patients.

3.4 The Department may deny a licensure renewal or suspend or revoke a license issued under these regulations on any of the following grounds:

3.4.1 Violation of any of the provisions of 16 Del.C. § 122(3) p or these regulations.

3.4.2 Permitting, aiding or abetting the commission of any illegal act in the facility.

3.4.3 Conducts or practices detrimental to the welfare of a patient.

3.4.4 Imposition of a disciplinary action.

3.4.4.1 The Department shall give 20 calendar days written notice to the holder of the license, setting forth the reasons for the determination;

3.4.4.2 The disciplinary action shall become final 20 calendar days after the mailing of the notice unless the licensee, within such 20-calender-day period, shall give written notice of the FSED desire for a hearing;

3.4.4.3 If the licensee gives such notice, the FSED shall be given a hearing before the Secretary of the Department or the Secretary's designee and may present such evidence as may be proper;

3.4.4.4 The Secretary of the Department or the Secretary's designee shall make a determination based upon the evidence presented.

3.4.4.5 A written copy of the determination and the reasons upon which it is based shall be sent to the FSED;

3.4.4.6 The decision shall become final 20 calendar days after the mailing of the determination letter unless the licensee, within the 20-calender-day period, appeals the decision to the appropriate court of the State

3.5 Order to immediately suspend a license.

3.5.1 In the event the Department identifies activities which the Department determines present an immediate jeopardy or imminent danger to the public health, welfare and safety requiring emergency action, the Department may issue an order temporarily suspending the licensee's license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee's attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 calendar days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing.

3.5.2 The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by mail, return receipt requested, to the licensee's last known address.

3.5.3 A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee's written request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department's decision to temporarily suspend the licensee's license.

3.5.4 As soon as possible, but in no event later than 60 calendar days after the issuance of the order of temporary suspension, the Department shall convene a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 calendar days of the receipt by the Department of such a request and shall render a decision within 30 calendar days.

3.5.5 In no event shall an order of temporary suspension remain in effect for longer than 60 calendar days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension may be vacated in favor of the disciplinary action ordered by the Department.

3.6 Renewal of License After Suspension or Revocation

3.6.1 If and when the conditions upon which the suspension or revocation of a license are based have been corrected and after a proper inspection has been made, a new license may be granted.

3.7 Modification of Ownership and Control (MOC)

3.7.1 Any proposed MOC must be reported to the Department in writing a minimum of 30 calendar days prior to the change.

3.7.2 A MOC occurs whenever the ultimate legal authority for the responsibility of the FSED's operation is transferred.

3.7.3 A MOC voids the current license in possession of the FSED.

3.7.4 A MOC will be treated as an initial license and the FSED must meet the current design and construction standards recognized by the Department.

3.7.5 A MOC may include but is not limited to:

3.7.5.1 Transfer of the FSED's legal title;

3.7.5.2 Transfer of the full ownership rights;

3.7.5.3 Transfer of the majority interest;

3.7.5.4 Transfer of ownership interest that results in the owner with the majority interest becoming a minority interest owner;

3.7.5.5 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights;

3.7.5.6 Transfer resulting in a measurable impact upon the operational control of the FSED;

3.7.5.7 Dissolution of any partnership that owns, or owns a controlling interest in the FSED;

3.7.5.8 Merger of a FSED owner (a corporation) into another corporation where, after the merger, the owner's shares of capitol stock are cancelled; or

3.7.5.9 The consolidation of a corporate FSED owner with one or more corporations;

3.7.6 Transactions which do not constitute an MOC include, but are not limited to the following:

3.7.6.1 Changes in the membership of a corporate board of directors or board of trustees;

3.7.6.2 Two or more corporations merge and the originally licensed corporation survives;

3.7.6.3 Changes in the membership of a non-profit corporation; or

3.7.6.4 Corporate stock transfers or sales that do not result in a transfer of interest or ownership.

3.7.7 Applications for licensure, as a result of an MOC must include a description of:

3.7.7.1 Any actual or anticipated change in the health care services provided before the MOC;

3.7.7.2 Any actual or anticipated change in staff, including the composition of staff;

3.7.7.3 Any actual or anticipated change in the policies and procedures; and

3.7.7.4 Any change in the manner of delivery of health care services.

3.8 Fees. Fees shall be in accordance with 16 Del.C. § 122(3) p.

3.9 Inspection. A representative of the Department shall periodically inspect every FSED for which a license has been issued under these regulations. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

3.10 Whoever operates a FSED in violation of these regulations shall be fined not less than $100.00 nor more than $1000.00 for each offense. Every day such violation continues shall constitute a separate and distinct offense.

16 Del. Admin. Code § 3340-3.0

24 DE Reg. 692( 1/1/2021) (final)