16 Del. Admin. Code § 3355-4.0

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

Section 3355-4.0 - General Requirements

4.1 The FSSC shall be in compliance with federal, state and local laws and codes.

4.2 The provisions of 42 CFR Ch. IV, Part 416, Subparts A, B and C, are hereby adopted as the regulatory requirements for FSSCs in Delaware. 42 CFR Ch. IV, Part 416 is hereby referred to, and made part of this Regulation, as if fully set out herein.

4.3 The provisions of the National Fire Protection Association's Life Safety Code, as adopted and modified by the State Fire Prevention Regulations, are hereby adopted as the regulatory requirements for FSSCs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

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

4.5 The provisions of the 2022 Facility Guidelines Institute's Guidelines for Design and Construction of Health Care Facilities, are hereby adopted as the regulatory requirements for FSSCs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

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

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

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

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

4.5.5 The FSSC shall comply with all local and state building codes and ordinances as pertain to this occupancy.

4.5.6 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.

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

4.7 The provisions of the State of Delaware, Department of Natural Resources and Environmental Control, Regulations Governing Solid Waste, 7 DE Admin. Code 1301, are hereby adopted as the regulatory requirements for FSSCs in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.

4.8 No policies shall be adopted by the FSSC which are in conflict with these regulations.

4.9 The FSSC shall advise the Department in writing within 15 calendar days following any change in the designation of the director or clinical director within the FSSC.

4.10 The FSSC 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 FSSC.

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

4.12 All records maintained by the FSSC shall at all times be open to inspection by authorized representatives of the Department.

4.13 The FSSC 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.

4.14 Reports of incidents, accidents and medical emergencies shall be kept on file at the FSSC for a minimum of five (5) years.

4.15 Report of major adverse incidents

4.15.1 The FSSC must report all major adverse incidents involving a patient to the Department within 48 hours in addition to other reporting requirements required by law.

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

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

4.15.2.2 An accident that causes serious injury to a patient;

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

4.15.2.4 Surgery on the wrong patient or wrong body part; or

4.15.2.5 The unexpected death of a patient.

4.15.3 Major adverse incidents must be investigated by the FSSC.

4.15.4 The FSSC must submit a complete report to the Department within 30 calendar days of the incident.

4.16 For those FSSCs that apply for and receive approval to remain open overnight:

4.16.1 Patients admitted to the FSSC will be permitted to stay 23 hours and 59 minutes, starting from the time of admission.

4.16.2 The time calculation begins when the patient is moved from the waiting room to begin the preparation for surgical services.

4.16.3 This time must be documented in the patient's medical record.

4.16.4 The discharge occurs when the physician has signed the discharge order and the patient has left the recovery room.

16 Del. Admin. Code § 3355-4.0

25 DE Reg. 627(12/1/2021)
26 DE Reg. 211( 9/1/2022) (Final)