CMS SOM App. H, Tag V593

§ 494.100(c) Standard: Support services. (1) …Services include, but are not limited to, the

following: (v) Monitoring of the quality of water and dialysate used by home hemodialysis

patients including conducting an onsite evaluation and . . .

Interpretive Guidance § 494.100 (c)(1)(v):

At the time of publishing these regulations (April 15, 2008, 73 FR 20369), several different

technologies for home hemodialysis were available. These included: conventional water

treatment components and single-pass (conventional) dialysis machines; integrated systems

which used manufacturer packaged, bagged dialysate or which incorporated water treatment

and dialysate preparation and delivery into one system; and, sorbent-based systems which

utilized columns (cartridges) of chemicals to regenerate the used dialysate for recirculation

through the dialyzer. All of these, and any future home hemodialysis technologies developed,

present the home dialysis facility with both common and unique challenges for monitoring to

ensure the continued efficacy and safety of the home hemodialysis patients’ treatments. Because

of their differences, the Interpretive Guidance for the following tags (V593-V598) at times refers

to one or more of the above-mentioned home hemodialysis technologies as related to the specific

requirements and/or exclusions from certain requirements.

Hemodialysis in the home requires specific infrastructure and organization of plumbing and

water. The facility home training staff must monitor the quality of water and dialysate used by

home hemodialysis patients and conduct on-site evaluations of the home hemodialysis patient’s

water supply prior to selecting a water treatment system for home hemodialysis to ensure

sufficient infrastructure is in place to deliver safe and effective dialysis treatments. Sufficient

infrastructure should include, but is not limited to: water supply that can meet the temperature

and water pressure demands, stable electrical supply to accommodate hemodialysis, and

plumbing requirements to ensure appropriate fittings and installations.

There should be evidence the source water to be used meets the minimum requirements specified

by the manufacturer of the water treatment components or of the integrated system, if such is in

use. If the source water requirements are not met, there needs to be adequate pre-treatment of

the source water to meet those requirements.

Each home water treatment system must include either an RO or a DI treatment component or

alternate technology that achieves AAMI standards, and a method to remove metals and

chemicals such as chlorine/chloramines.

According to AAMI RD52:2004/Annex C: Special considerations for home hemodialysis at C.3.1

Water supply, if the home is served by a small water system (serving less than 3000 persons), or

one classified as an economically or socially-disadvantaged system (serving less than 500

persons), the water entering the residence is not regulated by the EPA Safe Drinking Water Act.

Additionally, any municipal system may have received a variance, which can be granted by State

drinking water programs for chemical contaminants. If the water is supplied from an individual

well, the EPA standard may not be met.

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Due to these variables affecting the regulation of the water supply to a home for safe drinking

water standards, an annual analysis of the product water quality may not be sufficient. This is

because the quality of water from the well can change over time, and private wells are not

routinely monitored. More frequent analysis may be needed if the well is subject to seasonal

changes or contamination from sources such as septic tanks, underground fuel storage tanks, or

agricultural waste and chemicals. The additional monitoring may not require a full AAMI

analysis if only certain contaminants are known to be of concern.

The home patient’s record must include review and acknowledgement of any problems with the

source water, and a monitoring schedule for the source water. The patient’s physician should

demonstrate awareness of any issues with the source water, and the plan of care should address

any issues with source water for the home HD patient.

The home evaluation should address the storage of supplies, including dialysate concentrate(s).

The storage area should provide a year-round environment that meets the manufacturer’s

recommendations for storing supplies.

For home water treatment systems, guidance is found under the Condition for Water and

dialysate quality at V595, which highlights the recommendations in ANSI/AAMI RD52:2004:

Annex C “Special considerations for home hemodialysis.”