<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".10" citation="COMAR 10.05.04.10" title_num="10" subtitle_num="05" chapter_num="04" heading="Dialyzer Reuse.">
  <paragraph num="A.">
    <text>Patient Information.</text>
    <paragraph num="(1)">
      <text>The kidney dialysis center shall:</text>
      <paragraph num="(a)">
        <text>Provide information to the patient or, if appropriate, the patient's health care decision maker concerning the center's reuse of dialysis supplies, including hemodialyzers and tubing and their suitability for home dialysis; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Obtain the patient's or, if appropriate, the patient's health care decision maker's informed consent regarding the reuse of dialysis supplies.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The signed informed consent form shall be maintained in the patient's medical record.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Standards. If the kidney dialysis center reuses dialysis supplies, the medical director shall:</text>
    <paragraph num="(1)">
      <text>Develop a dialysis reuse policy in accordance with 42 CFR §§405.2139(a), 405.2140(a)(5), (b), and (c), and 405.2150, which are incorporated by reference; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Ensure compliance with the policy.</text>
    </paragraph>
  </paragraph>
</regulation>