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<regulation prefix="Regulation" num=".01" citation="COMAR 10.24.05.01" title_num="10" subtitle_num="24" chapter_num="05" heading="Definitions.">
  <paragraph num="A.">
    <text>In this chapter, the following terms have the meanings indicated.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Terms Defined.</text>
    <paragraph num="(1)">
      <text>“Commission” means the Maryland Health Care Commission.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>“C-PORT study” means the randomized clinical research trial that was conducted by the Atlantic Cardiovascular Patient Outcomes Team (C-PORT) to determine whether nonprimary PCI performed in hospitals without on-site cardiac surgery services is as safe and effective as nonprimary PCI performed in hospitals with on-site cardiac surgery services.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>“Nonprimary percutaneous coronary intervention” means PCI capable of relieving coronary vessel narrowing associated with coronary artery disease unrelated to ST-segment elevation myocardial infarction and includes elective PCI.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>“Percutaneous coronary intervention (PCI)” means a variety of catheter-based techniques, including balloon angioplasty, capable of relieving coronary vessel narrowing.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>“Primary PCI” means PCI capable of relieving coronary vessel narrowing associated with ST-segment elevation myocardial infarction (STEMI) and is also known as emergency PCI.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>“Regional service area” means the area used for planning for cardiac surgery and PCI services, as provided in the State Health Plan, COMAR 10.24.17.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>“Registry” means the C-PORT E Registry of Non-Primary PCI that follows-on the C-PORT E Study of Non-Primary PCI and that is:</text>
      <paragraph num="(a)">
        <text>Maintained by the Principal Investigator in the C-PORT E Study of Non-Primary PCI;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Overseen by the Johns Hopkins Institutional Review Board;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Overseen by a Data and Safety Monitoring Board.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(8)">
      <text>“STEMI” means coronary vessel narrowing associated with ST-segment elevation myocardial infarction.</text>
    </paragraph>
    <paragraph num="(9)">
      <text>“Waiver to perform nonprimary PCI” means a time-limited exemption from the requirements of COMAR 10.24.17.04E, Policy 5.0, by which the Commission permitted an acute care hospital without on-site cardiac surgery services to perform nonprimary PCI services within the C-PORT study.</text>
    </paragraph>
    <paragraph num="(10)">
      <text>“Waiver to perform primary PCI” means a time-limited exemption from the requirements of COMAR 10.24.17.04E, Policy 5.0, by which the Commission permits an acute care hospital without on-site cardiac surgery services to perform primary PCI services.</text>
    </paragraph>
  </paragraph>
</regulation>