CMS SOM App. H, Tag V595

(1) …Services include, but are not limited to, the

following: (v) …testing of the water and dialysate system in accordance with—

(B)…The facility must meet testing and other requirements of ANSI/AAMI RD52:2004. In

addition, bacteriological and endotoxin testing must be performed on a quarterly, or more

frequent basis as needed, to ensure that the water and dialysate are within the AAMI

limits.

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

Chlorine/chloramine levels must be tested prior to the start of each treatment (or before use of

each new batch of dialysate) in accordance with AAMI guidance and manufacturer’s

recommendations or instructions. An appropriate volume of water for the testing method in use

should be tested for the presence of chlorine/chloramines. For batch systems (integrated systems

that prepare enough dialysate for multiple treatments), the chlorine/chloramines testing shall be

performed at the worst-case scenario, i.e., after the preparation of each batch of dialysate, but

before use of that batch from a testing port that meets specifications of the manufacturer to be in

compliance with the requirements of AAMI. If the test results exceed AAMI’s maximum

allowable level, the user must discard the batch, replace any applicable components, prepare a

new batch of dialysate, and retest.

Recognize that systems that use sorbent technology do not produce water: the product of the

sorbent cartridge is dialysate, thus the requirements for the chemical, bacteriological and

endotoxin testing of water do not apply. With sorbent technology, due to the low volume of

exposure of patients to water (i.e. 6 liters per treatment) and the capacity of the single-use

sorbent cartridge to remove chlorine and chloramines, testing for chlorines and chloramines is

not required. Sorbent system users are expected to perform bacteriological and endotoxin testing

on dialysate.

The medical director must review the results of all water and dialysate cultures and endotoxin

levels, and analysis of source and product water for chemical contaminants of each home

hemodialysis patient. The facility must maintain documentation of the medical director’s review,

which should be incorporated as a part of the QAPI program review.

The results of water and dialysate testing for home hemodialysis patients may be included in the

patients’ medical records or in separate logs. According to AAMI, a log sheet should be

provided by the dialysis facility and used to record all measures of water treatment system

performance as required by the equipment manufacturer or the dialysis facility.

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The ANSI/AAMI RD52:2004 “Dialysate for Hemodialysis” has been incorporated by reference

into these regulations, as stated in § 494.40 Condition for Water and dialysate quality. CMS

interprets this reference as inclusive of the “Amendment 1 to ANSI/AAMI RD52:2004: Annex C

Special Considerations for Home Hemodialysis.” This document addresses concerns particular

to the home hemodialysis setting. Be aware that many of the provisions of RD52:2004, as

outlined in the Condition for water and dialysate quality at § 494.40, pertain to the home

hemodialysis setting when conventional water treatment equipment is used for water

purification. The review of conventional water treatment equipment should reference the

requirements listed in that Condition for the specific components in use in the home setting.

Additional pertinent recommendations from ANSI/AAMI RD52:2004 Annex C, which clarify

specific home hemodialysis issues, are as follows:

C.3 Utilities

It is recommended that the utility companies providing water and power to the patient’s home be

notified that home dialysis is being performed at that location and that restoring service after

any interruption should be a priority.

C.3.2 Drain

If the home has a septic tank, the septic tank should be able to process the volume of water from

a drain [that is one inch or larger in diameter]. It may not be possible to perform nocturnal

hemodialysis in a home with a septic tank since this tank may not be able to support the volume

of water delivered to it over an extended period (8 hours). Another possible limitation is that the

septic system will be exposed to disinfectant chemicals (bleach, peracetic acid, hydrogen

peroxide, etc.) which may kill the bacteria needed for the septic tank to function.

C.5.2 Softener

Attention must be paid to setting the time for softener regeneration, particularly when daily

nocturnal hemodialysis is being performed.

C.5.3 Carbon adsorption media

At least one carbon adsorption bed or filter should be installed even if the water supply is from a

well and no chlorine is present. In addition to chlorine, carbon can remove organic

contaminants from ground water, including solvents, pesticides, industrial wastes, and

substances leaking from underground storage tanks. When water is obtained from a municipal

water supply, two carbon adsorption devices connected in series and providing the equivalent of

an empty bed contact time of 10 minutes, or some other process incorporating safety redundancy

for chloramine removal, is recommended. A means should be provided to sample the water

between the two carbon adsorption devices. If chlorine is not present in the water, the carbon

should be changed on a routine schedule.

C.5.4 Reverse osmosis

Since the product flow rate will decrease with decreasing water temperature, a reverse osmosis

system installed without a tempering valve to ensure constant feed water temperature may need

to be oversized so that it will deliver the quantity of water required by the dialysis machine with

the coldest anticipated water temperature.

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C.5.5 Deionization

Deionization systems for home hemodialysis are not required to have a mechanism to prevent

product water from reaching the point of use if the conductivity of the water is one

microsiemen/cm or more (specific resistivity of one megohm-cm or less). However, this feature is

strongly recommended, particularly in situations where the water treatment system is not located

in the room where dialysis treatments are performed or when nocturnal hemodialysis is being

performed. If a diversion system is not installed, the patient must be trained to stop dialysis

immediately if the conductivity/resistivity monitoring system alarms.

C.5.6 Treated water distribution

Because systems used for home hemodialysis operate intermittently, the distribution system

should be designed and maintained to minimize bacterial proliferation. The reverse osmosis

system should be disinfected at least monthly according to the manufacturer’s instructions. The

dialysis machine should be disinfected following each treatment according to the manufacturer’s

instructions.

C.6.2 Acid concentrate

The patient/caregivers should be trained to know that different hemodialysis machines use

different proportioning ratios for concentrate and water and that they should ensure use of the

correct acid concentrate for their hemodialysis machine. The acid concentrate used should be

documented as part of the treatment record.

C.7 Monitoring

C.7.1 Water and dialysate quality

Sampling for microbiological testing should be performed before disinfecting the water

treatment system and dialysis machine. To avoid disconnecting hoses, and opening the system to

possible contamination, the system should be designed with the necessary sampling valves.

C.7.2 Equipment

C.7.2.1 General

A log sheet should be provided by the dialysis facility and used to record all measures of water

treatment system performance as required by the equipment manufacturer or the dialysis facility.

Measurements should be made at least 15 minutes after the water treatment system has been set

in operation and before dialysis is initiated. Any alarm associated with a component of the water

treatment system should be audible and visible in the patient treatment area. If any measure of

water treatment system performance is found to be outside its acceptable range, the dialysis

center should be notified.

C.7.2.2 Softener

When a softener is used, the water hardness should be monitored prior to each treatment using a

sample obtained through a labeled sample port located between the softener and the reverse

osmosis membranes. For hardness tests requiring color differentiation, the person performing

the analysis should be able to distinguish between the colors of blue, purple, and red. If the

person cannot differentiate these colors, an automated meter should be used.

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C.7.2.3 Carbon adsorption media

The chloramine concentration shall be checked prior to each treatment. It may be more

convenient to monitor total chlorine instead of chloramine. In that case, the acceptable level for

total chlorine shall be 0.1 mg/L, or less. The patient/caregiver shall be trained how to perform

the chlorine analysis, and shall be trained regarding what action to take if chlorine is detected

above the specified limit. Depending on the chlorine test used, the patient/caregiver should be

capable of distinguishing between different shades of pink or a digital meter should be used to

indicate the chlorine concentration. Digital meters should be calibrated to zero prior to testing

to ensure accurate measurements.

C.7.2.4 Reverse osmosis

Prior to each treatment, the performance of the reverse osmosis system should be monitored by

checking the product water conductivity and percent rejection.

End AAMI recommendations.

The facility home hemodialysis staff should be familiar with the recommendations in ANSI/AAMI

RD52 Annex C, and the facility policies, procedures and practice must reflect those applicable to

the home hemodialysis systems in use.

The microbiological quality of the dialysate should be analyzed quarterly using cultures and

endotoxin measurements, or more frequently, if indicated.

If integrated systems are in use, the dialysate should be tested for bacteria and endotoxins near

the end of the usability of any disposable water treatment or dialysate components. If the patient

uses manufacturer-provided bagged dialysate, cultures of those fluids are not required.

Refer to the Condition for water and dialysate quality at V178 and V180 for action and

maximum allowable culture and endotoxin levels in water and dialysate. Results that are out of

range require patient evaluation, notification of the patient’s physician/medical director, and

action taken per facility policy. Documentation should include culture/endotoxin results,

physician and medical director notification of any abnormal levels, and a corrective action plan

if results are out of range.

Records of results of chemical and microbial testing of home hemodialysis water and dialysate

should be available in the home setting and at the dialysis facility providing support; the log of

these results may be included the patient’s medical record or in a separate record.