Sec. 10.30.04.03. Water Standards — Water Treatment System — Dialysis Facilities

A. The dialysis facility shall record in a log system malfunctions or temporary failures to meet standards. Extended failure of 1 day or longer is unsuitable and out of compliance with these regulations.

B. The dialysis facility shall report system malfunctions at once to:

(1) The Office of Health Care Quality of the Department;

(2) The supplier as to the unprotected state of the dialysis facility; and

(3) The Commission.

C. If the freestanding dialysis facility experiences a water system failure that may threaten patient health or safety, the facility shall cease operations and implement its policies and procedures for handling emergencies, as provided in 42 CFR §494.40, which is incorporated by reference.

D. Each freestanding dialysis facility shall communicate water treatment issues with their local health emergency management agency and their local health officer.

E. Boiled Water Advisory.

(1) A facility may dialyze patients under a boiled water advisory if the water treatment components in use protect the product water from having chemical and microbial contamination.

(2) The facility shall have policies and procedures in place to identify the person responsible for monitoring the water quality and how often the treated water will be monitored.

(3) The medical director shall assure close monitoring of the product water under the boiled water advisory.

(4) If a deionization (DI) unit is being used as the main water treatment system, a submicron or endotoxin/ultrafilter downstream of the DI unit, diverted to the drain, shall be in place.

(5) If a deionization (DI) unit is being used as the main water treatment system:

(a) The deionization systems shall be monitored continuously:

(i) To produce water of one megohm/cm or greater specific resistivity; and

(ii) Using resistivity monitors that compensate for temperature and are equipped with audible and visual alarms which are audible in the patient care area;

(b) The audible and visible alarm shall be activated when the product water resistivity falls below 1.0 megohm/cm and the product water shall be prevented from reaching any point of use; and

(c) A submicron or endotoxin/ultrafilter downstream of the DI unit shall be in place.

(6) If an ultraviolet (UV) irradiator is used, the ultrafilter shall be:

(a) Located after the UV irradiator; and

(b) Monitored to detect any decrease in treated water quality.

(7) The facility shall perform weekly microbial assessment of the product water during the boiled water advisory.

(8) The facility shall maintain contact with the municipal water supplier in the event the water supplier chooses to "shock" treat (hyperchlorinate) the distribution system to bring it back into compliance with the acceptable standards for drinking water.

(9) The facility shall contact the municipal water supplier at least annually in writing to identify their location, contact information and the needs of the dialysis facility during any water service interruption.

(10) Shocking of Water System.

(a) In the event the municipal water supplier "shocks" the water system, chlorine/chloramine break through may occur. Water system testing procedures shall be reviewed with staff by the medical director to alert them for potential chlorine/chloramines break through so that patients will be protected from exposure to chlorine/chloramine.

(b) Every half-hour, the facility shall:

(i) Monitor the feed water for any increase in chlorine/chloramine; and

(ii) Test for chlorine/chloramine breakthrough after the first carbon filter.

(c) The half-hour testing described in §E(9)(b) of this regulation shall continue until 24 hours after feed water results return to normal.