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<regulation prefix="Regulation" num=".03" citation="COMAR 10.24.05.03" title_num="10" subtitle_num="24" chapter_num="05" heading="Conditions for Maintaining Authority to Perform Nonprimary PCI and Participation in Registry.">
  <paragraph num="A.">
    <text>A Registry hospital shall maintain compliance with the following requirements:</text>
    <paragraph num="(1)">
      <text>A Registry hospital shall meet the criteria established in the manual of operations of the C-PORT E Registry of Non-Primary PCI that follows-on the C-PORT E Study of Non-Primary PCI; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A Registry hospital shall continue to satisfy the following requirements:</text>
      <paragraph num="(a)">
        <text>For institutional resources:</text>
        <paragraph num="(i)">
          <text>Maintain a patient prioritization plan that guarantees that a patient who requires primary PCI for STEMI is given immediate preference for care in the cardiac catheterization laboratory;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Maintain a formal and properly executed written agreement with a tertiary care center that provides for the unconditional transfer of each non-primary PCI patient who requires additional care, including emergent or non-primary cardiac surgery or PCI, from the applicant hospital to the tertiary institution; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Maintain its agreement with an advanced cardiac support emergency medical services provider that guarantees arrival of the air or ground ambulance at the applicant hospital within 30 minutes of a request for non-primary PCI patient transport by the applicant;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>For physician resources, A Registry hospital shall maintain adequate staff necessary for the provision of primary and non-primary PCI services, including a minimum of three interventional cardiologists who:</text>
        <paragraph num="(i)">
          <text>Meet the requirements in the C-PORT E study research protocol and in COMAR 10.24.17, Table A-1;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Can be available on-site within 30 minutes when on call; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Agree to abide by the Device Selection Criteria in the applicable Manual of Operations;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>For minimum volumes, A Registry hospital shall maintain a minimum volume of 200 PCI procedures during each year of its waiver;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>For follow-up of patients enrolled in the C-PORT E study, A Registry hospital shall maintain a patient follow-up rate of 98 percent; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>For follow-up of patients enrolled in the Registry, A Registry hospital shall commit to patient follow-up through hospital discharge.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A Registry hospital shall notify the Commission in writing within 3 business days of the occurrence of any of the following:</text>
    <paragraph num="(1)">
      <text>The hospital performs non-primary PCI on a patient not enrolled in the Registry;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The hospital's primary PCI waiver expires, is relinquished, or is withdrawn;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The hospital fails to notify the Commission of the death of or a coronary artery bypass surgery experienced by a patient participating in the Registry;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The hospital fails to perform a minimum of 200 PCI procedures annually each year after it received a non-primary PCI research waiver from the Commission; or</text>
    </paragraph>
    <paragraph num="(5)">
      <text>The hospital fails to meet and maintain the criteria required by the Commission for participation in the Registry, or its participation in the Registry ends for any reason.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>A hospital required to give notice under §B of this regulation shall, on written notice from the Commission, immediately relinquish its authority to perform nonprimary PCI.</text>
  </paragraph>
</regulation>