16 Del. Admin. Code § 3340-4.0

Current through Register Vol. 28, No. 3, September 1, 2024

Section 3340-4.0 - General Requirements

4.1 When a facility is classified under this law or regulation and plans to construct or renovate any building, one (1) copy of properly prepared plans and specifications for the entire FSED are to be submitted to the Department. An approval, in writing, is to be obtained before such work is begun.

4.2 All records maintained by the FSED shall be open to inspection by authorized representatives of the Department.

4.3 The FSED must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations.

4.4 The term "emergency" or symbols which imply or indicate to the public that emergency medical treatment is available to individuals suffering from a life threatening medical condition shall not be used as part of the name of any facility in this State, unless the facility has been licensed by the Department as a FSED or hospital.

4.5 No policies shall be adopted by the licensee or FSED which are in conflict with these regulations.

4.6 The Department shall be notified, in writing within thirty (30) days of any changes in the director or clinical director of the facility.

4.7 The FSED must establish written policies regarding the rights and responsibilities of patients, and these policies and procedures are to be made available to patients, guardians, next of kin or sponsoring agency or agencies.

4.8 Each facility shall make available upon request to all patients or their representative, a complete statement enumerating all charges for service, materials and equipment which were furnished to the patient.

4.9 Each facility shall conspicuously post the prepayment policy. In the event of third-party payment denial, a policy statement must be developed in writing and available upon request as to the responsibility for payment.

4.10 A facility licensed under the provisions of this regulation as a "Free Standing Emergency Department", shall not refuse to render a needed, medically appropriate emergency service to any person.

4.11 A facility licensed as a FSED shall maintain the services, staff, equipment and drugs necessary to provide an appropriate medical screening evaluation and stabilization of a patient of any age who presents at the facility.

4.12 Each facility shall coordinate with the Office of Emergency Medical Services in regards to transfer agreements, communications requirements and disaster planning and preparedness.

4.13 The Office of Emergency Medical Services and the Office of Narcotics and Dangerous Drugs shall be notified by the Office of Health Facilities Licensing and Certification of any proposal of licensing of FSEDs.

4.14 The FSED must have a written transfer agreement, including a plan for transportation, in effect with one or more general acute care hospitals that provide basic or comprehensive emergency medical services wherein patients requiring more definitive care will be expeditiously transferred to receive prompt hospital care.

4.15 The FSED shall be in compliance with federal, state and local laws and codes.

4.16 The provisions of the Centers for Disease Control and Prevention Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005, are hereby adopted as the regulatory requirements for FSEDs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.17 The provisions of the 2018 Facility Guidelines Institute's Guidelines for Design and Construction of Health Care Facilities, are hereby adopted as the regulatory requirements for FSEDs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.17.1 When a FSED is classified under this law or regulation and plans to construct or renovate any buildings, one (1) copy of the properly prepared plans and specifications for the entire FSED shall be submitted to the Department.

4.17.2 An approval, in writing shall be obtained from the Department before construction/renovation work is begun.

4.17.3 Upon completion of construction/renovation, in accordance with the plans and specifications, the Department will inspect and approve the site prior to occupancy/use by the FSED.

4.17.4 All facilities shall either be at grade level or shall be equipped with ramps and elevators to allow easy access for persons with disabilities.

4.17.5 The FSED shall comply with all local and state building codes and ordinances as pertains to this occupancy.

4.17.6 Waiver of a standard requires Department approval. Waiver requests must be made in writing, include the full justification behind the request and address issues of safety and infection control. Waivers are an exception to established standards and will only be approved for compelling reason.

4.18 The provisions of the State of Delaware Food Code, 16 DE Admin. Code 4458, are hereby adopted as the regulatory requirements for FSEDs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.19 The FSED may contract for services to be provided to its patients. Individuals providing services under contract must meet the same requirements as those persons employed directly by the FSED.

4.20 Major Adverse Incidents

4.20.1 A major adverse incident includes but is not limited to:

4.20.1.1 Suspected abuse, neglect, mistreatment, exploitation, solicitation or harassment of patients;

4.20.1.2 An accident that causes serious injury to a patient;

4.20.1.3 A medication error with the potential to result in adverse health outcomes for the patient;

4.20.1.4 The unexpected death of a patient while under care of the facility;

4.20.1.5 A patient stay exceeding 23 hours; and

4.20.1.6 Activation of 9-1-1.

4.20.2 Reports of major adverse incidents shall be kept on file at the FSED for a minimum of five (5) years.

4.20.3 The FSED must report all major adverse incidents to the Department within 48 hours in addition to other reporting requirements required by law.

4.20.4 Major adverse incidents must be investigated by the FSED.

4.20.5 The FSED must submit a complete investigation report to the Department within 30 calendar days of the incident.

4.21 The FSED shall participate in the Delaware Health Information Network as data senders and end users.

4.22 To receive emergency medical services patients, the FSED must comply with the requirements and procedures for medical command facility designation set forth by the Division of Public Health's Office of Emergency Medical Services.

4.23 The provisions of the Americans with Disabilities Act of 1990 are hereby adopted as the regulatory requirements for FSEDs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.24 The provisions of Section 504 of the Rehabilitation Act of 1973. are hereby adopted as the regulatory requirements for FSEDs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

16 Del. Admin. Code § 3340-4.0

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