<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.07.17.06" title_num="10" subtitle_num="07" chapter_num="17" heading="Quality Assurance.">
  <paragraph num="A.">
    <text>The facility shall plan and implement a quality assurance program which includes:</text>
    <paragraph num="(1)">
      <text>Monitoring and evaluation of the quality of patient care;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Identification, evaluation, and resolution of care problems; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A peer review process.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Peer Review. The facility shall establish a peer review process that includes:</text>
    <paragraph num="(1)">
      <text>A mechanism to evaluate the clinical performance of each health care practitioner on a continuous basis, but not less than annually;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Procedures, approved by a supervising physician, to identify and minimize risks to the patient; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Documentation of each health care practitioner's annual evaluation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Equipment Quality Control.</text>
    <paragraph num="(1)">
      <text>The facility shall develop and implement a quality control procedure to monitor the safety and performance of all biomedical equipment.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>In developing its procedures, the facility shall consider:</text>
      <paragraph num="(a)">
        <text>FDA recommendations; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The equipment manufacturer's recommendations.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Quality Assurance Records. The facility shall document the following information for all quality assurance activities:</text>
    <paragraph num="(1)">
      <text>A description of identified problems;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Findings;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Conclusions;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Recommendations;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Actions taken;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Results; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Follow-up.</text>
    </paragraph>
  </paragraph>
</regulation>