CMS SOM App. H, Tag V175

§494.40 - Condition: Water and dialysate quality.

Interpretive Guidance § 494.40

This Condition incorporates the Association for the Advancement of Medical Instrumentation’s

(AAMI’s) “American National Standard for Dialysate for Hemodialysis,” 2004 (RD52:2004)

into the regulation. This AAMI document references portions of their “American National

Standard for Water Treatment Equipment for Hemodialysis Applications” (RD62:2001) as the

specifications for various water treatment components. The referenced portions of RD62:2001

are also incorporated into the regulation by reference.

The V-tags associated with the water and dialysate quality requirements are divided into 3 parts:

(1) the 2004 AAMI standard, (2) any related 2004 AAMI guidance that CMS identifies as

relevant, and (3) “Additional Guidance” where CMS provides its additional suggestions on how

to best comply with the AAMI guidance.

A survey of this Condition requires inspection of the water treatment and dialysate preparation

equipment, as well as their distribution systems; an interview with personnel responsible for the

day-to-day operation of those systems; and a review of the records of operation and testing for

those systems. Supervisory personnel may be interviewed to clarify issues or questions. Critical

to ensuring patient safety is the expectation that every survey visit include direct observation of

water testing for chlorine/chloramine.

Noncompliance at the Condition level should be considered if identified deficient practices are

pervasive throughout the Standards included in this Condition, serious in nature, and/or a

potential risk to patient health and safety.

Examples of potential Condition level noncompliance may include, but are not limited to:

• Demonstrated lack of knowledge or training of staff assigned responsibility for the

operation or monitoring of the water treatment or dialysate preparation systems;

• Failure to perform and document the test(s) for chlorine and chloramine accurately,

including the use of testing strips or reagents that are expired or not sensitive to the

required levels;

• Unsafe practices in the preparation, labeling, or delivery of dialysate; and,

• Failure to address out-of-range results for tests of water or dialysate (bacteria,

endotoxin, or chemical analysis).