CMS SOM App. H, Tag V179

4.1.2 Bacteriology of water

The manufacturer or supplier of a complete water treatment and distribution system

[must] demonstrate that the complete water treatment, storage, and distribution system is

capable of meeting these requirements at the time of installation.

Following the installation of a water treatment, storage, and distribution system, the user is

responsible for continued monitoring of the water bacteriology within the system and for

complying with the requirements of this standard, including those related to action levels.

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Interpretive Guidance § 494.40(a)

While this standard is primarily addressed to the manufacturer of equipment, each dialysis

facility’s medical director is responsible for the quality of medical care provided to patients. The

medical director oversees the installation and monitoring of the water treatment and distribution

system. Their failure to evaluate and validate the environment where devices and equipment will

be used may result in non-compliance with this requirement.

Existing facilities must monitor AAMI water chemical analysis and microbial testing and take

action if the results fall outside AAMI standards. If culture results exceed the action levels, the

facility may need to repeat cultures or disinfect the system and repeat cultures (depending on the

number of positive cultures, etc.) and continue treatment while awaiting the results.

AAMI recommendations at 4.1.1, Table 1, recommend maximum levels of contaminants above

which corrective measures should be taken. Testing should occur initially upon installation, and

at annual intervals thereafter. If the water supply for the facility is from a private well, an annual

analysis of the product water quality may not be sufficient to ensure that the feed water

requirements of the water treatment system in use are continuously met. The quality of water

from the well may 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. When more frequent than annual testing is performed by the dialysis facility, testing

may be limited to specific contaminants that are known to be of concern.

Frequency and methods for monitoring water bacteriology are addressed at V252 & V255.