<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 10.34.35.08" title_num="10" subtitle_num="34" chapter_num="35" heading="Performance Improvement Program.">
  <paragraph num="A.">
    <text>The performance improvement program shall consist of:</text>
    <paragraph num="(1)">
      <text>A committee which:</text>
      <paragraph num="(a)">
        <text>Consists of representation of personnel and varied areas of job responsibility; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Is responsible for analysis of data, reporting trends and corrective actions; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Meets at least quarterly;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Quality assurance and performance improvement monitoring parameters;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Documentation requirements for:</text>
      <paragraph num="(a)">
        <text>Established monitoring parameters;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Trend analyses; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Retention of committee meeting minutes for 3 years;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Documentation of tracking, trending, analyzing, resolving, and developing corrective action plans as appropriate for:</text>
      <paragraph num="(a)">
        <text>Medication errors;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Adverse drug reactions; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Equipment malfunctions;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Reporting of adverse events to regulatory and standard-setting bodies as applicable to State and federal regulations;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Documentation and resolution of patient care issues involving:</text>
      <paragraph num="(a)">
        <text>Incorrect equipment, supplies, or medications;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Delays in delivery of care;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Missed doses;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Patient infections;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Failures in after-hours care; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Patient, caregiver, or health care provider complaints;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(7)">
      <text>Documentation of patient outcomes;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Recall management;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Patient compliance monitoring; and</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Staff training and competency compliance.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The permit holder shall review the performance improvement program at a minimum of every 3 years.</text>
  </paragraph>
</regulation>