<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.05.04.06" title_num="10" subtitle_num="05" chapter_num="04" heading="Personnel.">
  <paragraph num="A.">
    <text>Medical Director.</text>
    <paragraph num="(1)">
      <text>The medical director shall:</text>
      <paragraph num="(a)">
        <text>Be a nephrologist or other physician with at least 12 months experience in the treatment of patients requiring chronic hemodialysis;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Be responsible for the development of patient care policies; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Provide medical guidance in the provision of patient care.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>If the medical director is not available to provide medical guidance, the administrator shall ensure the availability of an alternate physician with the same qualifications of the medical director as specified in §A(1)(a) of this regulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Charge Nurse. The charge nurse shall be a registered nurse with training in the provision of kidney dialysis services and at least 6 months experience in a dialysis center.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Dialysis Monitoring.</text>
    <paragraph num="(1)">
      <text>Staffing Ratio.</text>
      <paragraph num="(a)">
        <text>In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be:</text>
        <paragraph num="(i)">
          <text>A minimum of one staff member to three participants; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Sufficient to meet the needs of patients.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>In-Center Nocturnal Hemodialysis. When in-center nocturnal hemodialysis is performed, the monitoring individual-to-patient ratio at each center for in-center nocturnal hemodialysis shall be:</text>
        <paragraph num="(i)">
          <text>A minimum of one staff member to five participants; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Sufficient to meet the needs of the patients.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays.</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The charge nurse may not be included in the staffing ratio except:</text>
        <paragraph num="(i)">
          <text>When there are nine or fewer patients; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>In the event of an emergency.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Staffing Exception Reporting.</text>
      <paragraph num="(a)">
        <text>The center shall have a staffing exception reporting protocol in a format approved by the Department for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include, at a minimum:</text>
        <paragraph num="(i)">
          <text>The date and shift of the exception;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>A description of the emergency staffing situation;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Actions taken in response; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Any measures taken to ensure the center's future compliance.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>The exception reporting protocol shall be included in the center's quality assurance process.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(1) of this regulation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Monitoring individuals shall be trained in dialysis procedures and may be a:</text>
      <paragraph num="(a)">
        <text>Physician;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Physician assistant;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Registered nurse;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Licensed practical nurse; or</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Certified nursing assistant — dialysis technician.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The kidney dialysis center shall also provide dietetic and social work services and consultation by individuals with experience or training in caring for dialysis and transplant patients sufficient to meet the needs of patients.</text>
  </paragraph>
</regulation>