Adopts Without Amendments:

FGI Outpatient, 2018

Part 1 General

Part 2 Outpatient Facility Types

ANSI/ASHRAE/ASHE Standard 170-2017 Ventilation of Health Care Facilities

Heads up: There are no amended sections in this chapter.
Appendix material, shown in shaded boxes at the bottom of the page, is advisory only.
This chapter shall apply to renal dialysis centers that treat patients with chronic renal disease.
A2.10-1.1.1 Such facilities may provide outpatient dialysis, home treatment training and support, and dialyzer reuse services.
The renal dialysis center shall meet the standards in this chapter and the standards in Part 1 of these Guidelines.
Requirements set forth in Chapter 2.1, Common Elements for Outpatient Facilities, shall apply to renal dialysis centers as cross-referenced in this chapter.
See Section 2.1-2 (Accommodations for Care of Patients of Size) for requirements.
Where an exam room is provided, it shall meet the requirements in Section 2.1-3.2.1.2 (Single-patient examination/observation room).
The treatment area shall be permitted to be an open-plan area.
The treatment area shall be separate from administrative and waiting areas.
Built-in cabinetry shall not be permitted in individual hemodialysis patient care stations.
A2.10-3.2.1.3 Location of cabinetry in or near the dialysis station is inadvisable due to the risk of cross-contamination of stored items and the potential for inappropriate use of storage space for clean supplies and patient belongings.
(1)  Area. Individual hemodialysis patient care stations shall have a minimum clear floor area of:
(a) 80 square feet (7.44 square meters) where dialysis chairs are used
(b) 90 square feet (8.36 square meters) where gurneys are used
*(2)  Clearances. The following minimum clearances shall be provided:
(a) 4 feet (1.22 meters) between the sides of gurneys/dialysis chairs
(b) 3 feet (91.44 centimeters) between the sides of gurneys/dialysis chairs and adjacent walls or partitions
(c) 2 feet (60.96 centimeters) between the foot of a gurney/dialysis chair and a cubicle curtain
A2.10-3.2.2.1 (2) The requirement for a minimum of 4 feet (1.22 meters) between gurneys/dialysis chairs is due to the potential splash risk related to dialysis procedures and clearances needed for safe patient care. Requirements for provision of additional space may be a consideration for the ICRA.
Space shall be available to accommodate provisions for patient privacy.
Hand-washing stations shall be provided in accordance with Section 2.1-3.8.7 (Hand-Washing Station).
A hand-washing station shall be located at the entry to the hemodialysis treatment area. This hand-washing station shall be permitted to contribute to the total number of hand-washing stations required.
Where patients are trained to use dialysis equipment at home, a private treatment room of at least 120 square feet (11.15 square meters) shall be provided.
This room shall contain the following:
Counter
Hand-washing station
Separate drain for fluid disposal
Where patients who are hepatitis B surface antigen-positive will be dialyzed at the facility or an ICRA calls for an airborne infection isolation (AII) room, an AII room shall be provided.
A2.10-3.4.1 The AII room can be used for non-HBV-infected patients, assuming the facility does not have any HBsAg-positive patients on their current census and the room and equipment have been terminally cleaned and disinfected. Supporting language can be found in the Code of Federal Regulations at 42 CFR 494.30(a).
Where an AII room is provided, it shall comply with the requirements in Section 2.1-3.3.2 (AII Room).
The AII room shall have a minimum clear floor area of 120 square feet.
The AII room shall allow for direct observation of the patient by staff during treatment.
A nurse station that meets the requirements of Section 2.1-3.8.2 (Nurse Station) shall be located in the dialysis treatment area.
The nurse station shall be designed to provide visual observation of all dialysis patient care stations.
See Section 2.1-3.8.8 (Medication Safety Zones) for requirements.
A dedicated medication safety zone shall be centrally located in the dialysis center and shall be located at least 6 feet (1.83 meters) from any individual gurney/dialysis chair.
Where a nourishment station for the dialysis service is provided, it shall meet the requirements of Section 2.1-3.8.9 (Nourishment Area or Room).
A clean workroom and/or clean supply room shall be provided in accordance with Section 2.1-3.8.11 (Clean Workroom or Clean Supply Room).
A soiled workroom or soiled holding room shall be provided in accordance with Section 2.1-3.8.12 (Soiled Workroom or Soiled Holding Room).
Where blankets or other linens are used, a clean linen storage area shall be provided.
  1. Location of a clean linen storage area or covered cart in the clean workroom, in a separate closet, or using a covered cart distribution system shall be permitted.
  2. A covered cart stored in an alcove shall be out of the path of normal traffic and under staff control.
Storage areas or space for supply carts shall be provided.
  1. Wheelchair storage space shall be provided as indicated in Section 2.1-3.8.13.3 (Wheelchair storage and parking space).
  2. A minimum of one wheelchair storage or parking space shall be provided for every four patient care stations, with at least one storage or parking space provided where there are fewer than four patient care stations.
Support areas for staff shall include the following:
Lockers
A staff toilet room with hand-washing station
A patient toilet room with hand-washing station that meets the requirements in Section 2.1-3.8.7 (Hand-Washing Station) shall be provided.
The patient toilet room shall be equipped with a nurse call device. See Table 2.1-3 (Locations for Nurse Call Devices in Outpatient Facilities).
Toilet room doors. See Section 2.1-7.2.2.3 (5) (Doors for patient toilet rooms) for requirements.
Storage for patients' belongings shall be provided.
Where dialyzers are processed on-site for reuse, a reprocessing room shall be provided.
The dialyzer reprocessing room design shall provide for a one-way flow of materials from soiled to clean.
The dialyzer reprocessing room shall have the following:
  1. Refrigeration for temporary storage of dialyzers
  2. Decontamination/cleaning areas
  3. Hand-washing station
  4. Processors
  5. Computer processors and label printers
  6. A packaging area
  7. Dialyzer storage cabinets
Where dialysate preparation is conducted on-site, a dialysate preparation area shall be provided.
This area shall include the following:
  1. Hand-washing station
  2. Storage space
  3. Work counter for mixing and distribution equipment
  4. Floor drain
  5. Treated water outlet. See Section 2.10-8.4.1.2 (2) (Hemodialysis water distribution-Treated water distribution system).
An equipment repair and breakdown room shall be provided and equipped with the following:
Hand-washing station
Treated water outlet for equipment maintenance and drain or clinical service sink for equipment connection and testing
Work counter
Storage cabinet
See Section 2.1-8.4.3.8 (Emergency first-aid equipment) for requirements.
See Section 2.1-5.2 (Waste Management) for requirements.
An environmental services room for the exclusive use of the dialysis center shall be provided in accordance with Section 2.1-5.3.1 (Environmental Services Room).
Public areas shall be provided in accordance with Section 2.1-6.2 (Public Areas).
Office and clinical work space shall be provided in accordance with Section 2.1-6.3.3 (General or Individual Office Space).
See Section 2.1-6.3.5 (Medical Records) for requirements.
Surface materials shall be selected based on the infection control risk assessment.
See Section 2.1-8.3 (Electrical Systems) for requirements.
For plumbing system requirements, see Section 2.1-8.4 (Plumbing Systems) and additional requirements in this section.
  1. The following shall be provided:
    1. Separate treated water distribution system
    2. Drainage system independent from the tap water
  2. Treated water distribution system. This system shall meet the following requirements:
    1. The treated water system shall be in accordance with ANSI/AAMI/ISO 26722: Water Treatment Equipment for Hemodialysis and Related Therapies.
    2. Treated water distribution outlets shall be provided for these areas:
      1. Each individual hemodialysis patient care station
      2. Hemodialysis equipment repair area
      3. Dialysate preparation area
    3. Treated water systems for hemodialysis and related therapies shall meet the current requirements of ANSI/AAMI/ISO 13959: Water for Hemodialysis and Related Therapies.
  3. Dialysis equipment or water system components shall meet FDA 510 (k) approval and the requirements of Class 2 medical device(s).
  4. The liquid waste and disposal system for the hemodialysis treatment area shall be designed to minimize odor and prevent backflow.
  5. All hemodialysis distribution piping shall be readily accessible for inspection and maintenance.
Water treatment purification equipment shall be located in a dedicated area with space to access all components of the equipment.
  1. This area shall include a drain.
  2. This area shall be located in a secured space or room.
All hemodialysis water treatment and purification equipment shall be of materials and construction in accordance with ANSI/AAMI/ISO 26722: Water Treatment Equipment for Hemodialysis and Related Therapies.
See Section 2.1-8.5 (Communications Systems) for requirements.
See Section 2.1-8.6 (Fire Alarm Systems) for requirements.
See Section 2.1-8.7 (Elevator Systems) for requirements.
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