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

(a) Standard: Building. The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff, and the public.

(b) Standard: Equipment maintenance. The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.

(c) Standard: Patient care environment.

(1) The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff.

(2) The dialysis facility must:

(i) Maintain a comfortable temperature within the facility; and

(ii) Make reasonable accommodations for the patients who are not comfortable at this temperature.

(3) The dialysis facility must make accommodations to provide for patient privacy when patients are examined or treated and body exposure is required.

(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety (video surveillance will not meet this requirement).

(d) Standard: Fire safety.

(1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served.

(2) Notwithstanding paragraph (d)(1) of this section, dialysis facilities participating in Medicare as of October 14, 2008 that require sprinkler systems are those housed in multi-story buildings construction Types II(000), III(200), or V(000), as defined in the Life Safety Code, section 21.1.6.1, which were constructed after January 1, 2008, and those housed in high rise buildings over 75 feet in height, which were constructed after January 1, 2008.

(3) If CMS finds that a fire and safety code imposed by the facility's State law adequately protects a dialysis facility's patients, CMS may allow the State survey agency to apply the State's fire and safety code instead of the Life Safety Code.

(4) In consideration of a recommendation by the State survey agency or at the discretion of the Secretary, the Secretary may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon an ESRD facility, but only if the waiver will not adversely affect the health and safety of the patients.

(5) No dialysis facility may operate in a building that is adjacent to an industrial high hazard area, as described in sections 20.1.3.7 and 21.1.3.7 of the Health Care Facilities Code (NFPA 99 and its Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5, and TIA 12-6).

(e) Standard: Building safety.

(1) Dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must meet the applicable provisions of the Health Care Facilities Code, regardless of the number of patients served.

(2) Chapters 7, 8, 12, and 13 of the Health Care Facilities Code do not apply to a dialysis facility.

(3) If application of the Health Care Facilities Code would result in unreasonable hardship for the dialysis facility, CMS may waive specific provisions of the Health Care Facilities Code for such facility, but only if the waiver does not adversely affect the health and safety of patients.

(f) Incorporation by reference. The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain the material from the sources listed below. You may inspect a copy at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email [email protected], or go to: www.archives.gov/federal__register/cfr/ibr-locations.html. If any changes in the editions of the Codes are incorporated by reference, CMS will publish a document in the Federal Register to announce the changes.

(1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org, 1-617-770-3000.

(i) NFPA 99, Health Care Facilities Code, 2012 edition, issued August 11 2011.

(ii) TIA 12-2 to NFPA 99, issued August 11, 2011.

(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.

(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.

(v) TIA 12-5 to NFPA 99, issued August 1, 2013.

(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.

(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011.

(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.

(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.

(x) TIA 12-3 to NFPA 101, issued October 22, 2013.

(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.

(2) [Reserved]

[73 FR 20475, Apr. 15, 2008, as amended at 77 FR 29031, May 16, 2012; 81 FR 64042, Sept. 16, 2016; 84 FR 51832, Sept. 30, 2019]