.12 Water Standards.

A. The kidney dialysis center shall:

(1) Comply with 42 CFR §405.2140(a)(5), as amended, which is incorporated by reference; and

(2) Assure that the quality of water provided by a municipal water supply meets the federal Environmental Protection Agency standards for dissolved solutes.

B. Water Treatment System Safeguards.

(1) The kidney dialysis center shall use a water treatment system that offers satisfactory safeguards to patients, including:

(a) Appropriate prefiltration for particulate matter;

(b) Reverse osmosis monitored by resistivity or conductivity, or an equivalent method, or both; or

(c) A mixed-resin bed deionizer with a one megohm monitors light, or an equivalent method.

(2) Prefiltration shall be followed by charcoal filtration before reverse osmosis, or deionization, or both.

C. The kidney dialysis center shall monitor microbial levels described in §B(1) of this regulation on a monthly basis.

D. The kidney dialysis center shall maintain a log of water treatment system function and monitor the values on each occasion the machine is operated.

E. The kidney dialysis center shall record in a log system malfunctions or temporary failures to meet standards.

F. The kidney dialysis center shall report any system malfunction greater than 1 working day's duration, within 24 hours of discovery of the malfunction, to:

(1) The Office of Health Care Quality;

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

(3) The Commission on Kidney Disease.

G. If the kidney dialysis center experiences a water system failure that may threaten patient health or safety, the center shall cease operations and implement its policies and procedures for handling emergencies, as provided in 42 CFR §405.2140(d), as amended which, is incorporated by reference.