<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".09" citation="COMAR 10.07.21.09" title_num="10" subtitle_num="07" chapter_num="21" heading="Quality Assurance.">
  <paragraph num="A.">
    <text>The governing body shall ensure that the hospice care program conducts ongoing quality assurance and utilization review.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Quality Assurance Program. The governing body shall assure that the hospice care program develops and implements a quality assurance and improvement program to assess and improve the quality of services being provided by the program.</text>
  </paragraph>
  <paragraph num="C.">
    <text>The quality assurance and improvement program shall:</text>
    <paragraph num="(1)">
      <text>Focus on:</text>
      <paragraph num="(a)">
        <text>The needs, expectations, and satisfaction of patients and their families; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>All services provided by the hospice care program;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Have outcomes and results that are measurable and which may be incorporated into systemic changes in the program's operation;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Require the systematic collection, review, and evaluation of information and data and the analysis of trends identified through the quality assurance process;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Require that regular reports are prepared and reviewed by the governing body and appropriate personnel;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Provide for prompt and appropriate response to incidents when the patient's health and safety is at risk; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Include proactive strategies to improve the quality of services.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The hospice care program shall:</text>
    <paragraph num="(1)">
      <text>Establish goals and standards to measure the quality of the services being delivered and define how these standards are measured;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Maintain records to demonstrate the effectiveness of its quality assurance activities;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Implement changes based upon results of the evaluated data; for example, when problems are identified in the provision of services, the hospice care program shall document corrective actions taken, including ongoing monitoring, revisions of policies and procedures, and educational interventions;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Identify the individual responsible for performing the quality assurance functions as set forth in this regulation; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Review the quality assurance and improvement program at least annually and make revisions as necessary.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>The hospice care program shall be held accountable by the governing body for accomplishing the goals and standards that are established as part of the quality assurance and improvement system.</text>
  </paragraph>
  <paragraph num="F.">
    <text>Utilization Review.</text>
    <paragraph num="(1)">
      <text>The hospice care program shall have a written plan for monitoring the allocation and utilization of patient and family services in order to identify and resolve concerns relating to the allocation and utilization of these services. The plan shall include:</text>
      <paragraph num="(a)">
        <text>Goals and objectives for utilization review;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Use of objective written criteria or treatment protocols to guide decisions about utilization of services;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The analysis of the need for services;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Time frames for review;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Methods for identifying utilization review concerns and mechanisms for resolving problems; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>A confidentiality policy consistent with legal and regulatory requirements.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The hospice care program shall review the utilization review plan at least annually and make revisions as necessary.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The plan shall include a monitoring protocol to address the following utilization concerns:</text>
      <paragraph num="(a)">
        <text>The appropriateness of the services being provided, including the level of intensity;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Patient admissions, including delays in the admission process; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Delays in the provision of services and specific treatment modalities.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>When the hospice care program identifies utilization problems, the hospice care program shall document corrective actions taken, including ongoing monitoring and educational interventions, as well as revisions to policies and procedures, and changes in the provision of services.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Reports to the Secretary.</text>
      <paragraph num="(a)">
        <text>Within 90 days after the close of a hospice care program's fiscal year, the hospice care program shall submit to the Department a report of the services it provided during the last fiscal year.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The report shall include the:</text>
        <paragraph num="(i)">
          <text>Types of services the hospice care program provided;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Number of patients provided each type of service;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Number of family members provided each type of service; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Changes in the number of patients or family members provided services from the previous year.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>