16 Del. Admin. Code § 3330-9.0

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

Section 3330-9.0 - Physical Environment

9.1 The dialysis center must be designed, constructed, equipped and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.

9.1.1 The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, staff and the public.

9.1.2 The dialysis center must implement and maintain a program to ensure that all equipment used at the dialysis center and by home dialysis patients is maintained and operated in accordance with the manufacturer's recommendations.

9.1.2.1 The use of "dummy" drip chambers is acceptable only for machine maintenance purposes and shall not be present in the patient treatment areas.

9.1.2.2 The dialysis center shall have a plan of operation and routine maintenance that, at a minimum, includes:

9.1.2.2.1 Hemodialysis delivery system;

9.1.2.2.2 Water treatment system;

9.1.2.2.3 Ancillary equipment;

9.1.2.2.4 Emergency equipment; and

9.1.2.2.5 Furniture.

9.1.3 The area for treating each patient must be sufficient to provide needed care and services, prevent contamination, and to accommodate medical emergency equipment and staff.

9.1.4 The dialysis center must make accommodations to provide for patient privacy any time body exposure is required during treatment or examination.

9.1.5 Each patient, including the face, vascular access site and bloodline connections, must be in view of staff at all times during hemodialysis treatment.

9.1.5.1 Video surveillance does not meet this requirement.

9.1.6 Emergency equipment, including but not limited to, oxygen, airways, suction, defibrillator, artificial resuscitator, and emergency drugs, must be on the premises at all times and immediately available for use.

9.2 Fire Safety

9.2.1 The dialysis center shall comply with the rules and regulations of the State Fire Prevention Commission.

9.2.2 The dialysis center must be inspected annually by the fire marshal having jurisdiction, and all applications for license (new and renewal) must include documentation, dated within the past 12 months, indicating compliance to all applicable fire code regulations.

9.2.2.1 Failure to provide documentation from the fire marshal having jurisdiction, dated within the past 12 months, indicating compliance with all applicable fire code regulations shall be grounds for licensure discipline.

9.2.3 An evacuation floor plan shall be prominently and conspicuously posted for display throughout the facility in areas that are readily visible to patients, staff, and visitors.

9.2.4 The dialysis center shall conduct one (1) fire drill per shift per quarter.

9.2.4.1 Fire drills shall include the transmission of the fire alarm signal and simulation of the emergency fire condition, simulation of evacuation of patients and other occupants, and use of fire-fighting equipment.

9.2.4.2 Written reports shall be maintained to include evidence of patient and staff participation.

9.3 Construction

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

9.3.1.1 When a dialysis center is classified under this law or regulation and plans to construct, extensively remodel or convert any buildings, two (2) copies of the properly prepared plans and specifications for the entire dialysis center shall be submitted to the Department.

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

9.3.1.3 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 dialysis center.

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

9.3.1.5 The dialysis center shall comply with all local and state building codes and ordinances as pertains to this occupancy.

9.3.1.6 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 reasons.

9.3.1.7 Dialysis centers existing prior to the implementation of this regulation shall continue, at a minimum, to meet the building requirements specified in the original approval.

16 Del. Admin. Code § 3330-9.0

22 DE Reg. 853( 4/1/2019) (final)