US · guidance
CMS SOM App. H, Tag V196
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
6.2.5 Carbon adsorption (monitoring and testing frequency)
Testing for free chlorine, chloramine, or total chlorine should be performed at the
beginning of each treatment day prior to patients initiating treatment and again prior to
the beginning of each patient shift. If there are no set patient shifts, testing should be
performed approximately every 4 hours.
Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a
log sheet.
Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-
diethyl-p-phenylene- diamine (DPD) based test kits or dip-and-read test strips. On-line
monitors can be used to measure chloramine concentrations. Whichever test system is used,
it must have sufficient sensitivity and specificity to resolve the maximum levels described in
[AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L].
Samples should be drawn when the system has been operating for at least 15 minutes. The
analysis should be performed on-site, since chloramine levels will decrease if the sample is
not assayed promptly.
Interpretive Guidelines § 494.40(a)
ANSI/AAMI RD52:2004
5.2.5 Carbon adsorption
In addition to removing free chlorine and chloramine, carbon also adsorbs a wide variety of
other substances, including both naturally occurring and synthetic organic compounds. The
capacity of carbon to remove free chlorine and chloramine may be reduced when other
substances “mask” reactive sites on the carbon media. Additionally, the efficiency of free
chlorine and chloramine removal is reduced as the pH increases or the temperature decreases.
The net effect of those variables is that the finite capacity of carbon beds to remove free chlorine
and chloramine cannot be predicted with any certainty. Therefore, their performance needs to be
monitored frequently.
6.2.5 Carbon adsorption
Carbon adsorption performance is monitored by measuring free chlorine and/or chloramine
concentrations in the water exiting the first carbon bed of a series-connected pair. It should be
Page 56 of 420
noted that sampling for total chlorine (the sum of free chlorine and chloramine), allowing a
maximum level of 0.1 mg/L of total chlorine, is often simpler than analyzing for free chlorine and
chloramine separately.
More frequent monitoring may be appropriate during temporary operation with a single carbon
bed, which can occur following breakthrough of the first bed. In such instances, testing is
performed on water exiting the second carbon bed in a series-connected pair. The decision to
increase the frequency of monitoring should be based on the system's past performance and
whether changes in feed water quality have occurred.
AAMI Rationale for the Development and Provision of This Recommended Practice
A.6 Monitoring
A.6.2.5 Carbon adsorption
Intensive monitoring of carbon adsorption beds is recommended due to the long history of
adverse events associated with chloramine contamination of dialysate. Chloramine
concentrations in municipal water can fluctuate from day to day, and the capacity of carbon
adsorption beds to remove chloramine can vary depending on the pH and temperature of the
water, the nature of the chloramine compounds present, and the presence of other substances in
the water. The dependence of chloramine removal on multiple factors makes the performance of
carbon adsorption beds unpredictable. Patient safety can only be ensured by intensively
monitoring the performance of the carbon adsorption bed. Configuring carbon adsorption beds
in series and sampling from a port located between the two beds provides one margin of
protection against chloramine breakthrough. When chloramine is first detected in the effluent
from the first adsorption bed, essentially the full capacity of the second bed remains available for
chloramine removal. This reserve capacity allows the user to conveniently replace the exhausted
bed without risk to patients. The exhausted bed is discarded, the second bed is moved into the
first position, and a new bed is placed in the second position. A new bed of virgin carbon shall
be used for replacement. Carbon cannot be regenerated in a dialysis facility, and the use of
regenerated carbon is prohibited by ANSI/AAMI RD62:2001 (see 2.3 in that AAMI document).
Backwashing of carbon beds does not regenerate the carbon, although it may allow more
efficient use of the bed’s capacity by removing channels that can form in the bed during routine
operation.
AAMI Rationale for the Development and Provision of This Recommended Practice
A.6.2.5 Carbon adsorption
The recommendation that the water purification system operate for at least 15 minutes before
sampling is to guard against inadvertently drawing water that has been in the bed for an
extended period.
Suggested monitoring guidelines from ANSI/AAMI RD52, Table 4, include:
For carbon adsorption beds, monitor the product water levels of free chlorine and/or total
chlorine between the beds prior to beginning each patient shift. The expected result is less than
or equal to 0.1 mg/L of total chlorine.
Additional Guidance:
Page 57 of 420
For parallel-connected tanks/beds, testing must be performed for each set of tanks/beds each
time testing is conducted.
Test strips with color comparison charts that indicate a low-level reading of zero and a first
“number” of 0.5 are not sufficiently sensitive to detect levels as low as 0.1 and should not be
used for testing product water for safe levels of chlorine/chloramine. An indication of “0” on the
comparison charts does not suffice to demonstrate that the strips are sensitive to “0.” Consult
the manufacturer’s guidance or contact the manufacturer if there are any questions regarding
the sensitivity of specific test strips. When deciding whether to use a “quantitative” or
“qualitative” test methodology, it is essential to recognize that determining low levels of
chlorine (i.e., <0.1 ppm) requires the use of the quantitative method.
If an online chlorine/chloramines monitor is in use that incorporates an automated alarm,
particular testing times are not required. Facility policy and practice should follow the
manufacturer’s guidance regarding any required comparison testing and calibration of the
monitor.
The ability to discern colors is a crucial job function for individuals responsible for interpreting
colorimetric tests. Depending on the test method used, staff assigned this responsibility must be
capable of properly interpreting the results and accurately distinguishing and identifying any
colorimetric results; alternatively, a digital meter must be used. If a digital meter is used, it
should be calibrated to zero before testing to ensure accurate measurements.
For deficient practices with exceeding the acceptable level of chlorine or chloramine refer to
V270-273 of this section.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
82d517f0aaea18f237c5e12bc1740f1614cc79e75c1e4c15ccd4967888decdf4
The link goes to the issuing authority’s own document — the one we read to produce this record. Where a source publishes whole titles rather than sections, your browser may need a moment to jump to the provision.
Unofficial copy of government-published law, reproduced from official sources with full provenance. Not an official publication; verify against official sources before relying on it in a filing. Records in the 'guidance' corpus, and only that corpus, are sub-regulatory (interpretive guidelines, survey procedures) and are not binding law. Validity bounds follow each jurisdiction's declared temporalBasis.