<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".11" citation="COMAR 10.07.08.11" title_num="10" subtitle_num="07" chapter_num="08" heading="Quality Assurance.">
  <paragraph num="A.">
    <text>The freestanding medical facility shall develop and implement a quality assurance program.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The quality assurance program shall have a quality management process that:</text>
    <paragraph num="(1)">
      <text>Is multidisciplinary;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Is integrated into the hospital's overall quality management program that is reported to the hospital's governing body;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Has a structure to ensure that defined program outcomes and performance measures are developed and monitored regularly;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Maintains sufficient documentation to:</text>
      <paragraph num="(a)">
        <text>Verify problems;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Identify opportunities for improvement; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Show corrective actions taken and resolution of problems;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Includes review of morbidity and mortality; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Evaluates medical care, nursing care, utilization review, tissue review, and pre-hospital care.</text>
    </paragraph>
  </paragraph>
</regulation>