<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 30.08.16.02" title_num="30" subtitle_num="08" chapter_num="16" heading="Cardiac Interventional Center.">
  <paragraph num="A.">
    <text>A Cardiac Interventional Center shall be licensed as an acute care hospital by the hospital licensing authority in the jurisdiction in which it is located.</text>
  </paragraph>
  <paragraph num="B.">
    <text>If located in Maryland, a Cardiac Interventional Center shall:</text>
    <paragraph num="(1)">
      <text>Have one of the following:</text>
      <paragraph num="(a)">
        <text>A Certificate of Need (CON) issued by the Maryland Health Care Commission for a cardiac surgery and percutaneous coronary intervention (PCI) program; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A current waiver issued by the Maryland Health Care Commission to provide primary percutaneous coronary intervention (PCI) services to STEMI patients meeting certain criteria without on-site cardiac surgery; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Be a base station approved under COMAR 30.03.06.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>If not located in Maryland, a Cardiac Interventional Center shall:</text>
    <paragraph num="(1)">
      <text>Possess all government approvals required to provide Primary PCI under the laws of the jurisdiction in which it is located including, if required, a CON; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Satisfy one of the following:</text>
      <paragraph num="(a)">
        <text>Be a base station approved under COMAR 30.03.06; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Have the equipment necessary to conduct a dual consult between EMS and a Maryland base station for each Maryland patient transported to the Cardiac Interventional Center.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>A Cardiac Interventional Center shall:</text>
    <paragraph num="(1)">
      <text>Provide primary PCI as soon as possible and not to exceed 90 minutes from patient arrival, that is, door to balloon time of less than 90 minutes, for 75% of appropriate STEMI patients;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Provide primary PCI for appropriate STEMI patients 24 hours per day, 7 day per week;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Have adequate physician, nursing, and technical staff to provide cardiac catheterization and coronary care unit services 24 hours per day, 7 days per week;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Have a single call access system for receiving patients with STEMI;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Participate in the County Hospital Alert Tracking System (CHATS) program;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Abide by the Maryland Emergency Medical Services Inter-Hospital Transfer Guidelines published by MIEMSS in addition to any applicable transfer requirements in COMAR 10.24.17;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Communicate as soon as possible with the STEMI patient's primary physician and cardiologist regarding patient outcome;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Establish a Cardiac Interventional Center medical review committee which shall be a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland, as a committee established in the Maryland Institute for Emergency Medical Services Systems which:</text>
      <paragraph num="(a)">
        <text>Meets at least three times a year;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Reviews practice patterns; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Modifies practice patterns as appropriate; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(9)">
      <text>Comply with the requirements of COMAR 30.08.04, including participating in:</text>
      <paragraph num="(a)">
        <text>A Cardiovascular Data registry jointly approved by MHCC and MIEMSS, including any registry data reporting requirements established by either MIEMSS or MHCC; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>State specialty care quality management activities of MIEMSS or of MHCC that are approved by MIEMSS.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>