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<chapter num="07" heading="Specialty Referral Center Designation Criteria" title_num="30" subtitle_num="08">
  <regulation prefix="Regulation" num=".01" heading="General Criteria.">
    <text>Unless otherwise indicated in this subtitle, MIEMSS shall use the following criteria when designating or reverifying specialty referral centers from among those applicant hospitals that apply for designation or reverification and when contracting with out-of-State specialty referral center hospitals:</text>
    <paragraph num="A.">
      <text>Applicable standards in this subtitle;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Patient volume;</text>
    </paragraph>
    <paragraph num="C.">
      <text>Geographic coverage;</text>
    </paragraph>
    <paragraph num="D.">
      <text>Population;</text>
    </paragraph>
    <paragraph num="E.">
      <text>Demonstrated expertise of the professional staff in the specific specialty care area;</text>
    </paragraph>
    <paragraph num="F.">
      <text>Active research program focused on specific specialty care area;</text>
    </paragraph>
    <paragraph num="G.">
      <text>Competing applications; and</text>
    </paragraph>
    <paragraph num="H.">
      <text>New applications.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Exceptions.">
    <text>The criteria listed in Regulation .01 of this chapter do not apply to burn, perinatal, neonatal, or designated primary stroke specialty referral centers.</text>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Additional Considerations.">
    <text>When applying the criteria, MIEMSS may consider:</text>
    <paragraph num="A.">
      <text>Applicable guidelines and professional standards;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Patient outcome standards; and</text>
    </paragraph>
    <paragraph num="C.">
      <text>Published results of peer-reviewed research.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Compliance with Standards.">
    <text>An applicant hospital shall comply with the applicable standards for specialty referral centers in this subtitle.</text>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Patient Volume.">
    <paragraph num="A.">
      <text>When considering an applicant hospital, MIEMSS shall take into account the number and distribution of specialty referral centers that will allow designated or contract specialty referral centers to:</text>
      <paragraph num="(1)">
        <text>Minimize duplication of services;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Achieve and sustain the volumes necessary for:</text>
        <paragraph num="(a)">
          <text>Optimal outcome,</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Cost efficiency,</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Maintenance of expertise,</text>
        </paragraph>
        <paragraph num="(d)">
          <text>Quality care,</text>
        </paragraph>
        <paragraph num="(e)">
          <text>Research, and</text>
        </paragraph>
        <paragraph num="(f)">
          <text>Physician and nurse education; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Minimize the potential adverse effect on quality of care that may result if patient volumes are reduced,</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Volume criteria will be evaluated for each specialty referral center based on the:</text>
      <paragraph num="(1)">
        <text>Projected number of patients who would require access to that specialty referral center; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Number of physicians who would provide medical care for that population.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Geographic Coverage.">
    <text>When considering an applicant hospital, MIEMSS shall:</text>
    <paragraph num="A.">
      <text>Minimize duplicative services within close proximity; and</text>
    </paragraph>
    <paragraph num="B.">
      <text>Consider the number, geographic distribution, and resource capabilities of other specialty referral centers.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".07" heading="Population.">
    <text>When considering an applicant hospital, MIEMSS shall take into account the applicant hospital's geographic specialty patient catchment area given the current and projected population density within an area.</text>
  </regulation>
  <regulation prefix="Regulation" num=".08" heading="Professional Staff Expertise.">
    <text>When considering an applicant hospital, MIEMSS shall take into account the education and specialty training of the following hospital staff:</text>
    <paragraph num="A.">
      <text>Physicians;</text>
    </paragraph>
    <paragraph num="B.">
      <text>Nurses; and</text>
    </paragraph>
    <paragraph num="C.">
      <text>Technicians and support staff.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".09" heading="Active Research Program.">
    <text>When considering an applicant hospital, MIEMSS may give preference to the applicant with an established and ongoing clinical research program focusing on the specific specialty care area.</text>
  </regulation>
  <regulation prefix="Regulation" num=".10" heading="Competing Applications.">
    <paragraph num="A.">
      <text>MIEMSS may give preference to an applicant hospital with a designated trauma center which supports or is supported by the presence of a specialty referral center.</text>
    </paragraph>
    <paragraph num="B.">
      <text>If there are two or more applicants for the same type of specialty referral center in the same geographic coverage area where patient volumes or population would likely be insufficient to support both applicants, based on the criteria in Regulations .04—.09 of this chapter, MIEMSS shall:</text>
      <paragraph num="(1)">
        <text>Give preference to the applicant with an established specialty referral program that can demonstrate that its past experience and performance:</text>
        <paragraph num="(a)">
          <text>Are indicative of quality patient care,</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Are consistent with professional standards, and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Result in optimal patient outcome; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Consider demonstrated patient outcomes and the recommendations of the site survey team to determine the most qualified applicant if both applicants have been verified through MIEMSS' inspection as meeting the standards for the requested specialty referral center.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".11" heading="New Applicants.">
    <text>An applicant hospital that, under this subtitle, has not previously been designated as a specialty referral center by MIEMSS or contracted with MIEMSS as a specialty referral center shall:</text>
    <paragraph num="A.">
      <text>Be subject to the specialty referral center designation criteria; and</text>
    </paragraph>
    <paragraph num="B.">
      <text>Demonstrate that its proposed specialty referral center can generate sufficient patient volume without adversely affecting patient volumes at other existing, designated, or contract specialty referral centers.</text>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: August 9, 1999 (26:16 Md. R. 1247)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 1, 2002 (29:12 Md. R. 933)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 5, 2006 (33:11 Md. R. 952)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 1, 2002 (29:12 Md. R. 933)</annotation>
    <annotation type="History" subtype="Administrative History">Regulations .05 —.11 amended effective July 1, 2002 (29:12 Md. R. 933)</annotation>
  </annotations>
</chapter>