Health, Family Health and Preparedness, Licensing

Rule R432-650

End Stage Renal Disease Facility Rules

Notice of Proposed Rule

(Amendment)

DAR File No.: 35472
Filed: 11/18/2011 04:20:13 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

Coordinate with federal requirements that went into effect in 2009. These changes have been vetted in two meetings with providers and interested parties and have been approved by the Health Facilities Committee.

Summary of the rule or change:

The rule mimics federal standards that went into effect in 2009 including the adoption of chapter 20 of the NFPA 101 Life Safety Code and provisions for blood borne isolation for patients with Hepatitis B (HBV+).

State statutory or constitutional authorization for this rule:

• Title 26, Chapter 21

Anticipated cost or savings to:

the state budget:

The cost of printing and distribution of the revised rule. State expenses are expected to be completed within the usual course of business and existing budgets. NFPA 101 Life Safety Code is federal condition of participation in Medicare and Medicaid and is adopted by the Office of the State Fire Marshal. NFPA 101 should already be in the DAR library.

local governments:

The rule change has no impact on local government because these standards are enforced at the state level.

small businesses:

The rule restates federal requirements that are already in effect. There are no new substantive requirements.

persons other than small businesses, businesses, or local governmental entities:

The rule restates federal requirements that are already in effect. There are no new substantive requirements.

Compliance costs for affected persons:

The rule change will not increase compliance costs for providers.

Comments by the department head on the fiscal impact the rule may have on businesses:

This rule has been extensively discussed with the regulated businesses and they appear to concur that updating the rule to adopt updated federal accessibility standards and the 2010 edition of the Guidelines for Design and Construction of Health Care Facilities is appropriate. Public comment received will be carefully evaluated for any unforeseen fiscal impact.

David Patton, PhD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Health
Family Health and Preparedness, Licensing
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Joel Hoffman at the above address, by phone at 801-538-6279, by FAX at 801-538-6024, or by Internet E-mail at jhoffman@utah.gov
• Andrew Baxter at the above address, by phone at 801-538-6140, by FAX at 801-538-6325, or by Internet E-mail at andrewbaxter@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

01/17/2012

This rule may become effective on:

01/24/2012

Authorized by:

David Patton, Executive Director

R432. Health, Family Health and Preparedness, Licensing.

R432-650. End Stage Renal Disease Facility Rules.

R432-650-1. Legal Authority.

This rule is adopted pursuant to Title 26, Chapter 21.

 

R432-650-14. Physical Environment.

The following standards apply for new construction and remodeling of ESRD facilities:

(1) R432-4-1 through R432-4-22 is adopted and incorporated by reference.

(2) ESRD Facilities shall comply with NFPA 101 Life Safety Code, Chapter 20 except that an essential electrical system is not required.

[(1)](3) The treatment area may be an open area and shall be separate from the administrative and waiting area. Individual treatment areas must contain at least 80 square feet. Each treatment area shall have the capacity for privacy for each patient for treatment related procedures or personal care.

[(2)](4) The dialysis treatment area must include a nurses station designed to provide visual observation of the patient treatment area.

[(3)](5) There shall be at least one hand washing facility serving no more than eight stations. All hand washing stations shall be convenient to the nurses station and treatment areas.

(6) A separate blood borne infectious isolation patient treatment room shall be provided and shall:

(a) be fully enclosed;

(b) contain a handwash sink;

(c) contain widows to permit observation of the patient from the nurse station and other treatment areas;

(d) contain space for clean and soiled gowns and supplies; and

(e) be dedicated to patients with blood borne diseases and shall not be used by patients without blood borne diseases.

[(4)](7) If an airborne infectio[n]us isolation room is required to control airborne infection, the airborne infectious isolation room shall have a separate hand washing facility and comply with R386-702, Communicable Disease Rule, and other applicable standards determined in the pre-construction plan review process. The room shall be tightly sealed and all air from the room shall be exhausted. Exhaust air shall be a minimum of 125 cubic feet per minute greater than supply air.

(a) The airborne infectious isolation rooms may be used for patients without airborne communicable disease when not in use as an isolation room.

[(5)](8) If the ESRD facility provides home dialysis training, a private treatment room of at least 120 square feet is required for patients who are being trained to use dialysis equipment at home. The room shall contain a counter, hand washing facilities, and a separate drain for fluid disposal.

[(6)](9) Each ESRD facility must provide a clean work area that is separate from soiled work areas. If the area is used for preparing patient care items, it must contain a work counter, hand washing facilities, and storage facilities for clean and sterile supplies. If the area is used only for storage and holding as part of a system for distribution of clean and sterile materials, the work counter and hand washing facilities may be omitted.

[(7)](10) Each ESRD facility must provide a soiled work [area]room that contains a hand washing sink, work counter, storage cabinets, waste receptacles and a soiled linen receptacle.

[(8)](11) If dialyzers are reused, a reprocessing room is required that is sized and equipped to perform the functions required and to include one-way flow of materials from soiled to clean with provisions for refrigerated temporary storage of dialyzers, a decontamination and cleaning area, sinks processors, computer processors and label printers, a packaging area, and dialyzer storage cabinets.

[(9)](12) If a nourishment station for dialysis service is provided, the nourishment station must contain a sink, a work counter, a refrigerator, storage cabinets, and equipment for serving nourishments as required.

[(10)](13) Each ESRD facility must have an environmental services closet immediately available to the treatment area. The closet must contain a floor receptor or service sink and storage space for housekeeping supplies and equipment.

[(11)](14) If an equipment maintenance service area is provided, the service area must contain hand washing facilities, a work counter and a storage cabinet.

[(12)](15) Each ESRD facility must provide a supply area or supply carts.

[(13)](16) Storage space out of the direct line of traffic shall be available for wheelchairs and stretchers, if stretchers are provided.

[(14)](17) Each ESRD facility must provide a clean linen storage area commensurate with the needs of the facility. The storage area may be within the clean work area, a separate closet, or distribution system. If a closed cart distribution system is used for clean linen, the cart must be stored out of the path of normal traffic.

[(15)](18) Each ESRD facility using central batch delivery system, must provide, either on premises or through written arrangements, individual delivery systems for the treatment of any patient requiring special dialysis solutions.

[(16)](19) Each ESRD facility must house water treatment equipment in an enclosed room at a sufficient distance from the patient treatment area to prevent machinery and operational noise from disturbing patients.

[(17)](20) Each ESRD facility must provide a patient toilet with hand washing facilities immediately adjacent to the treatment area.

[(18)](21) Each ESRD facility must provide lockers, toilets and hand washing facilities for staff.

[(19)](22) Each ESRD facility must provide a secure storage area for patients' belongings.

[(20)](23) A waiting area with seating accommodations shall be available or accessible to the dialysis unit. A toilet room with hand washing facilities, a drinking fountain, and a telephone for public use shall be available or accessible for use by persons using the waiting room.

[(21)](24) Office and clinical work space shall be available for administrative services.

(25) All finishes shall be tight fitting, easily maintained and cleanable, resistant to cleaning chemicals, and detailed to minimize the potential for microbial growth.

(26) The reprocessing room, water treatment room, supply rooms, clean and soiled work rooms, soiled holding rooms shall be lockable and restricted to authorized personnel only.

(27) The reprocessing room, soiled work, holding room, and environmental services closet shall have continuous exhaust ventilation at the rate of not less than 10 air changes per hour and sufficient to generate inward air flow.

(28) Patient and public toilet rooms and exam rooms shall be equipped with an emergency call system. The call system shall require only momentary contact to activate, shall identify the source of the call and shall be cancelable only at the source of the call. The call system in toilet rooms shall be accessible to a collapsed patient lying on the floor. Inclusion of a pull cord will satisfy this requirement.

 

KEY: health care facilities

Date of Enactment or Last Substantive Amendment: [October 1, 2011]2012

Notice of Continuation: September 27, 2007

Authorizing, and Implemented or Interpreted Law: 26-21-5; 26-21-16