CMS SOM App. H, Tag V596

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

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

(C) The dialysis facility must correct any water and dialysate quality problem for the home

hemodialysis patient, and if necessary, arrange for backup dialysis until the problem is

corrected if—

(1) Analysis of the water and dialysate quality indicates contamination; or

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(2) The home hemodialysis patient demonstrates clinical symptoms associated with water

and dialysate contamination.

Interpretive Guidance § 494.100 (c)(1)(v)(C)(1) and (2):

If analysis of the water and/or dialysate quality indicates contamination (i.e. microbial action

levels or maximum level(s) of chemical contaminants are exceeded), the facility should evaluate

for possible sample contamination and at minimum, when the threat is low, re-test. If the threat

is higher or the re-test remains positive, the facility must correct the water treatment and/or

dialysate delivery (machine) system to ensure product water and dialysate meet AAMI standards

for chemical levels and microbial counts.

When unable to make such corrections in time to allow home hemodialysis to resume within an

acceptable time frame, the dialysis facility must arrange for back-up dialysis until the home

system is corrected. If an integrated system is involved and all applicable disposable components

are replaced, treatment may continue, with testing to continue per schedule.

If the patient exhibits clinical symptoms associated with water and dialysate contamination that

cannot be readily attributed to other causes, the facility must arrange for back-up dialysis until

the problem is investigated and resolved. Clinical symptoms for water/dialysate contamination

may include, but are not limited to, chills, shaking, fever, vomiting, headache, dizziness, muscle

weakness, skin flushing, itching, diarrhea, hyper/hypotension, hemolysis, and anemia. If such

symptoms are present, the facility must notify the patient’s physician/medical director to

determine appropriate action (i.e., culture and treatment).

Facility policies must address, and responsible staff members (e.g., home training nurse, chief

technician responsible for the home program, etc.) must be aware of what responsive and

corrective actions they should take if microbial and/or chemical test results were elevated, or

should a patient exhibit such clinical symptoms, including but not limited to referral for

immediate patient evaluation and treatment by the patient’s physician or a non-physician

practitioner (i.e., advanced practice registered nurse, or physician assistant) and, possible

arrangement for back-up dialysis, if needed, until the cause of the symptoms is identified and any

problems with the home water treatment and dialysate delivery system are resolved.