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<chapter num="16" heading="Cardiac Interventional Center Standards" title_num="30" subtitle_num="08">
  <regulation prefix="Regulation" num=".01" 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>“Cardiac Interventional Center” means:</text>
        <paragraph num="(a)">
          <text>An in-State hospital that meets the requirements in Regulation .02 of this chapter and is designated by MIEMSS and approved by the EMS Board to receive patients transported by ambulance with acute ST-segment elevation myocardial infarction (STEMI) who need Primary Percutaneous Coronary Intervention; or</text>
        </paragraph>
        <paragraph num="(b)">
          <text>An out-of-State hospital that has entered into an agreement with MIEMSS and has been approved by the EMS Board to receive patients with acute ST-segment elevation myocardial infarction who need Primary Percutaneous Coronary Intervention.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>“Jurisdiction” means a state, commonwealth, or the District of Columbia.</text>
      </paragraph>
      <paragraph num="(3)">
        <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="(4)">
        <text>“Primary PCI” means PCI capable of relieving coronary vessel narrowing associated with acute ST-segment elevation myocardial infarction (STEMI).</text>
      </paragraph>
      <paragraph num="(5)">
        <text>“STEMI” means coronary vessel narrowing associated with ST-segment elevation myocardial infarction.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" 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>
  <regulation prefix="Regulation" num=".03" heading="Catheterization Lab.">
    <text>A Cardiac Interventional Center may receive STEMI patients transported by ambulance directly to the catheterization lab when approved by the base station physician if the catheterization lab has a physician, appropriately credentialed to evaluate and stabilize an acute cardiac patient, a registered nurse, and a technician, capable of activating the catheterization lab, immediately available in house when:</text>
    <paragraph num="A.">
      <text>The 12 lead EKG in the field is interpreted by an advanced life support EMS provider as a high probability of a STEMI; or</text>
    </paragraph>
    <paragraph num="B.">
      <text>The 12 lead EKG in the field has been reviewed by an ED physician, a cardiologist, or both, and determined to be a STEMI.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Site Reviews.">
    <paragraph num="A.">
      <text>Notwithstanding COMAR 30.08.02.06, MIEMSS may designate any Cardiac Interventional Center without a site review.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Notwithstanding §A of this regulation, MIEMSS staff may conduct an onsite review to verify compliance with this chapter, including:</text>
      <paragraph num="(1)">
        <text>Inspecting the hospital's physical plant;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Interviewing team members and management personnel;</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Examining the hospital's Cardiac Interventional Center related documents, including patient care records; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Reviewing other materials considered appropriate by MIEMSS.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>The Maryland Health Care Commission staff may participate in any review conducted by MIEMSS to verify compliance with COMAR 30.08.15, including reviewing application materials, and participating in any on-site review.</text>
    </paragraph>
    <paragraph num="D.">
      <text>MIEMSS staff may participate in any review conducted by the Maryland Health Care Commission to verify compliance with COMAR 10.24.17, including reviewing application materials, and participating in any on-site visits.</text>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: May 3, 2010 (37:9 Md. R. 674)</annotation>
  </annotations>
</chapter>