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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 117END STAGE RENAL DISEASE FACILITIES
SUBCHAPTER HPHYSICAL PLANT AND CONSTRUCTION REQUIREMENTS
RULE §117.102Construction Requirements for a New End Stage Renal Disease Facility

    (E) The dialysis equipment shall be designated, reserved, and used for hepatitis B positive patients only.

    (F) Disinfection of dialysis equipment shall occur in the hepatitis B treatment isolation room and shall meet the requirements of §117.33(d)(2)(C) of this title (relating to Sanitary Conditions and Hygienic Practices).

    (G) As of February 9, 2009, all new facilities or increasing the number of in-center dialysis treatment stations in existing facilities shall have an isolation room or be granted a waiver by Centers for Medicare and Medicaid Services. The waiver shall demonstrate that there is sufficient capacity in the geographic area for isolation rooms for hepatitis B positive patients. A written request for waiver shall be made through the Texas Department of State Health Services, Health Facility Compliance Group, Mail Code 1979, P.O. Box 149347, Austin, Texas, 78714-9347 for transmission to CMS.

  (5) When home training is provided in the facility, a private treatment area of at least 120 square feet exclusive of fixed and movable cabinets and shelves shall be provided. This room shall contain a work counter, a hand washing sink with hands-free operable controls, and a separate drain for fluid disposal.

  (6) A sufficient number of janitor's closets shall be provided throughout the facility to maintain a clean and sanitary environment. The closet shall contain a floor receptor or service sink and storage space for housekeeping supplies and equipment.

  (7) When laboratory services are provided on site the following shall be provided and meet the requirements of §117.45(l) of this title (relating to Provision and Coordination of Treatment and Services).

    (A) The laboratory workroom/area shall include a counter and a sink with hands-free operable controls. Laboratory services and medication preparation and dispensing shall not be done within the same designated space.

    (B) Cabinets or closets shall be provided for supplies and equipment used in obtaining samples for testing.

    (C) Refrigerated specimen storage shall be provided for specimens waiting for transfer to off-site testing. The refrigerators shall be maintained with documentation of the appropriate temperature for such storage.

  (8) When laundry and linen is provided, processing may be done within the center or off site at a commercial laundry.

    (A) When on-site linen processing is provided, soiled and clean processing operations shall be separated and arranged to provide a one-way traffic pattern from soiled to clean areas. The following rooms and items shall be provided:

      (i) a soiled linen processing room which includes areas for receiving, holding, sorting, and washing;

      (ii) a clean linen processing room which includes areas for drying, sorting, folding, and holding prior to distribution;

      (iii) supply storage cabinets in the soiled and clean linen processing rooms;

      (iv) hand washing sink within the soiled linen processing room; and

      (v) a storage room for clean linen. Clean linen storage may be combined with the clean work room.

    (B) When linen is processed off site, the following areas shall be provided:

      (i) clean linen shall be stored within the clean supply area; and

      (ii) soiled linen shall be stored in a designated space in the facility.

  (9) Space shall be provided for the safe storage and disposal of waste as appropriate for the material being handled and in compliance with all applicable rules and regulations.

  (10) At a minimum, the medication area shall include a counter, a refrigerator, and a hand washing sink with hands-free operable controls. Storage and preparation of medication shall be done from a medication area and shall be under visual control of nursing staff. Medication preparation, dispensing and laboratory services shall not be done within the same designated areas. The refrigerators used for storage of medications shall be maintained with documentation of the appropriate temperatures for such storage.

  (11) When peritoneal dialysis (PD) training is provided within the ESRD facility, a patient treatment training room shall have a minimum of 120 square feet of clear floor area exclusive of fixed and movable cabinets and shelves.

    (A) The PD treatment room shall contain cabinets, a work counter, and a hand washing sink with hands-free operable controls.

    (B) An additional clinical sink or equivalent flushing rim sink with hands-free operable controls shall be provided. The clinical sink or equivalent flushing rim sink and the hand washing sink shall have a minimum separation of 6 feet.

    (C) A physical partition between the clinical sink or equivalent flushing rim sink and the hand washing sink may be constructed in-lieu-of the 6 foot separation. The partition shall be a minimum of 5 feet in height from the finished floor and 2 feet in width from the wall or from the wall to the front edge of the countertop whichever is greater.

  (12) When a reuse room is provided, the room shall be sufficiently sized to house dialyzers reprocessing area, breakdown area, a storage area/room and work area. All fixed and moveable equipment shall require a minimum of three feet of clear and unobstructed working space on all sides of fixed or moveable equipment that require access for staff. The reuse room shall include a work counter, deep utility service sink and separate hand washing sink with hands-free operable controls, refrigerator and storage space and shall meet the requirements of §117.32(d) of this title (relating to Water Treatment, Dialysate Concentrates, and Reuse).

    (A) Dialyzers reprocessing area shall be arranged for the one-way movement from soiled dialyzers and materials to cleaning and storage.

    (B) Breakdown of dialyzers shall be processed in the soiled processing area of the reprocessing area. The deep utility service sink with hands-free operable controls shall be located within the soiled processing area. There shall be adequate storage space to store the soiled/used dialyzers before processing occurs. The minimum depth of the utility sink shall not be less than 14 inches.

    (C) The reuse room shall provide either a separate storage room or within the reuse room storage space to store all reprocessed cleaned dialyzers. There shall be a definitive separation between storing used and reprocessed dialyzers, and the temperature in the storage areas shall be maintained in accordance with the manufacturer's direction for use.

  (13) The treatment area(s) or rooms shall be separate from the administrative area(s).

    (A) When individual hemodialysis patient treatment room(s) is provided, the room shall have a minimum of 120 square feet of clear floor area exclusive of fixed and movable cabinets and shelves. The patient treatment room shall contain cabinets, work counter, and a hand washing sink with hands-free operable controls.

    (B) In multiple-treatment stations, each individual patient treatment area shall be 80 square feet exclusive of fixed or wall mounted cabinets and built-in shelves. A minimum of 8 feet width shall be provided for the head wall for each station. The clearance between the side of a chair and a wall shall be a minimum of 3 feet, and the back of the extended chair and a wall shall be a minimum of 1 foot. A clear unobstructed width of 3 feet 8 inches shall be available at the foot of each treatment area(s) outside of the 80 square feet treatment area for passage of equipment, gurneys, and personnel.

    (C) The multiple-treatment station area shall contain cabinets, work counters, and hand washing sinks with hands-free operable controls. The fixed and moveable cabinets and shelves shall not encroach upon the patient treatment station.

    (D) A nurse station shall be located within the dialysis treatment area(s) and designed to provide visual observation of all patient stations. The nurse station shall have counters for storage and access to a hand washing sink(s) with hands-free operable controls.

    (E) One hand washing sink with hands-free operable controls shall be provided for every six stations. Sinks shall be uniformly distributed.

    (F) When required or requested, privacy shall be provided for each patient in the open treatment area with portable moveable screens.

(e) Service areas.

  (1) A clean storage room or closet shall be provided for patient care items, clean and sterile supplies.

  (2) Emergency eyewash shall be provided conveniently for staff use and comply with ANSI Z358.1.

  (3) Dialysis solutions may be processed from a central batch delivery system or prepared in an on-site mixing room. When provided, a mixing room shall include a sink, storage space, and holding tanks.

  (4) Patient toilet rooms shall be located within the treatment area(s) and include hand washing sink(s) with hands-free operable controls. Patient toilet room shall be at a ratio of 1 toilet room for every 40 treatment stations or fraction thereof.

Cont'd...

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