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Title: Section 757.2 - Additional requirements for chronic renal dialysis centers

Effective Date


Section 757.2 Additional requirements for chronic renal dialysis centers.

(a) Whenever referred to in this Part, the following definitions shall have the following meanings:

(1) Dialysis station means an individual patient treatment area that accommodates the dialysis equipment and the routine and emergency care indicated, and is sufficiently separate from other dialysis stations to afford protection from cross-contamination with blood-borne pathogens. A hemodialysis station shall be equipped with a chair or a bed, a hemodialysis machine, and access to a purified water source and dialysate concentrates.

(2) End-Stage Renal Disease (ESRD) network means entities contracted with the federal government that collect and share data and other information with the Centers for Medicare and Medicaid Services (CMS), New York State and chronic renal dialysis centers within a specific geographic area.

(3) Chronic renal dialysis center means an ambulatory care facility approved by CMS to provide chronic renal dialysis services and licensed by the New York State Department of Health to provide such services.

(4) Home dialysis means dialysis provided at home by a patient or care partner who is trained by a registered professional nurse to deliver dialysis (peritoneal or hemodialysis) treatments at the patient’s place of residence. The nurse responsible for home dialysis training must be a registered professional nurse who meets the licensure and practice requirements of New York State, has 12 months experience providing nursing care and 3 months experience working
as a nurse in the specific dialysis modality (peritoneal or hemodialysis).

(5) Dialysate means aqueous fluid containing electrolytes and, usually, dextrose, which is intended to exchange solutes with blood during hemodialysis. It is the fluid made from water and concentrates delivered to the dialyzer by the
dialysate supply system.

(6) Product water means water produced by a water treatment system or by an individual component of a system.

(b) Operators of chronic renal dialysis centers shall comply with Parts 751 and 752 of this Subchapter.

(c) The operator of a chronic renal dialysis center that provides pediatric services on other than an emergency basis, shall obtain pediatric nephrology consultation services with one or more board certified pediatric nephrologists. Such board certified pediatric nephrologist(s) shall follow current evidence based professionally accepted clinical practice standards for evaluating and monitoring the pediatric dialysis patients.

(d) Each chronic renal dialysis center certified for home dialysis services must ensure through its interdisciplinary team, that home dialysis services are at least equivalent to those provided to patients who receive such services at the chronic renal dialysis center, and meet all applicable requirements contained in Title 42 of the Code of Federal Regulations, Part 494, Conditions for Coverage for End-Stage Renal Disease Facilities, 2008 edition.

(e) Each chronic renal dialysis center shall ensure that its water treatment and dialysate supply systems protect hemodialysis patients from adverse effects arising from known chemical and microbial contaminates that may be found in water and improperly prepared dialysate. Each chronic renal dialysis center shall develop, implement and comply with policies and procedures related to water treatment, dialysate, and reuse that are understandable and include the following:

(1) sample of product water and a sample of dialysate shall have a microbiological examination at least once every month;

(2) sample of product water shall have a chemical examination at least once every three months; and

(3) water samples shall be examined by a laboratory licensed pursuant to Section 502 of the Public Health Law that is approved by the Department for the analysis of potable water.

(f) Each chronic renal dialysis center shall ensure that dialysis stations meet the requirements set forth in subdivision (a) (1) of this section.

(g) Each chronic renal dialysis center shall collaborate with its ESRD network, suppliers, utility service providers and the Department for surveys and for emergency preparedness, and shall also collaborate with other chronic renal dialysis centers to ensure that lifesaving dialysis services are available in the event of an emergency or disaster. The chronic renal dialysis center shall develop written policies and procedures that detail the actions it shall take and plan to be implemented in the event of an emergency or disaster.


VOLUME E (Title 10)