<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".12" citation="COMAR 10.05.04.12" title_num="10" subtitle_num="05" chapter_num="04" heading="Water Standards.">
  <paragraph num="A.">
    <text>The kidney dialysis center shall:</text>
    <paragraph num="(1)">
      <text>Comply with 42 CFR §405.2140(a)(5), as amended, which is incorporated by reference; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Assure that the quality of water provided by a municipal water supply meets the federal Environmental Protection Agency standards for dissolved solutes.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Water Treatment System Safeguards.</text>
    <paragraph num="(1)">
      <text>The kidney dialysis center shall use a water treatment system that offers satisfactory safeguards to patients, including:</text>
      <paragraph num="(a)">
        <text>Appropriate prefiltration for particulate matter;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Reverse osmosis monitored by resistivity or conductivity, or an equivalent method, or both; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A mixed-resin bed deionizer with a one megohm monitors light, or an equivalent method.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Prefiltration shall be followed by charcoal filtration before reverse osmosis, or deionization, or both.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The kidney dialysis center shall monitor microbial levels described in §B(1) of this regulation on a monthly basis.</text>
  </paragraph>
  <paragraph num="D.">
    <text>The kidney dialysis center shall maintain a log of water treatment system function and monitor the values on each occasion the machine is operated.</text>
  </paragraph>
  <paragraph num="E.">
    <text>The kidney dialysis center shall record in a log system malfunctions or temporary failures to meet standards.</text>
  </paragraph>
  <paragraph num="F.">
    <text>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:</text>
    <paragraph num="(1)">
      <text>The Office of Health Care Quality;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The supplier as to the unprotected state of the dialysis facility; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The Commission on Kidney Disease.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>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.</text>
  </paragraph>
</regulation>