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<regulation prefix="Regulation" num=".08" citation="COMAR 10.05.01.08" title_num="10" subtitle_num="05" chapter_num="01" heading="Quality Assurance Program.">
  <paragraph num="A.">
    <text>The administrator shall ensure that the facility develops and maintains 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 administrator shall ensure that the facility establishes 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 qualified health care practitioner 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>Practitioner Performance Evaluation in a Facility.</text>
    <paragraph num="(1)">
      <text>The administrator shall ensure that the facility establishes a practitioner performance evaluation process that includes a review of care which shall:</text>
      <paragraph num="(a)">
        <text>Be undertaken for cases chosen at random and for cases with unexpected adverse outcomes;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Be based on objective review standards;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Include a review of the appropriateness of the plan of care for the patient, particularly any medical procedures performed on the patient, in relation to the patient’s condition; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Be conducted by at least two members of the medical staff who:</text>
        <paragraph num="(i)">
          <text>As appropriate, are of the same specialty as the member of the medical staff under review; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Have been trained in the freestanding ambulatory care facility’s policies and procedures regarding practitioner performance evaluation.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A review of the care provided by a member of the medical staff who is a solo practitioner shall be conducted by an external reviewer.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A freestanding ambulatory care facility shall take into account the results of the practitioner performance evaluation process for a member of the medical staff in the reappointment process.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Equipment Quality Control.</text>
    <paragraph num="(1)">
      <text>The administrator shall ensure that the facility develops 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 administrator 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="F.">
    <text>Documentation.</text>
    <paragraph num="(1)">
      <text>At the time of application, the applicant shall submit a written description of the facility's quality assurance program which includes, at a minimum:</text>
      <paragraph num="(a)">
        <text>A description of how the facility will comply with §A of this regulation; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The manner in which information will be collected.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The facility shall submit any revisions to its quality assurance program at the time of licensure renewal.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <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>