<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".05" citation="COMAR 10.05.02.05" title_num="10" subtitle_num="05" chapter_num="02" heading="Inspection by OHCQ.">
  <paragraph num="A.">
    <text>A licensee operating a freestanding birthing center shall undergo a routine annual survey.</text>
  </paragraph>
  <paragraph num="B.">
    <text>A licensee shall allow an on-site survey by the Department at any time during the center’s normal hours of operation to evaluate the center’s compliance with the applicable requirements and standards of this chapter.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Center employees shall make data and records accessible within a reasonable time during the on-site survey.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Notice of Deficiencies.</text>
    <paragraph num="(1)">
      <text>If a survey identifies noncompliance with a requirement, the Secretary shall:</text>
      <paragraph num="(a)">
        <text>Issue a written Statement of Deficiencies that cites each deficiency;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Require the freestanding birthing center to submit an acceptable Plan of Correction within 10 calendar days of receipt of the Statement of Deficiencies;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Notify the freestanding birthing center of any sanctions or that failure to correct the violation may result in sanctions; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Offer the freestanding birthing center the opportunity for IDR.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Plan of Correction.</text>
    <paragraph num="(1)">
      <text>The freestanding birthing center shall submit a written Plan of Correction to the OHCQ that documents steps the licensee will take to come into compliance, including:</text>
      <paragraph num="(a)">
        <text>How the freestanding birthing center will correct each deficiency;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The date by which each deficient practice will be corrected;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>How the freestanding birthing center will prevent the deficient practice from recurring; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Who will be responsible for ensuring the deficiency will not reoccur.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Failure to return an acceptable Plan of Correction within the allotted time frame may result in a sanction.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A request for an IDR does not change the freestanding birthing center's requirement to submit a Plan of Correction for all deficiencies within 10 calendar days after receipt of the notice of deficiency.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Immediate Jeopardy.</text>
    <paragraph num="(1)">
      <text>Declaration of Immediate Jeopardy.</text>
      <paragraph num="(a)">
        <text>When the OHCQ identifies a situation in which immediate corrective action is necessary because the freestanding birthing center's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public, an immediate jeopardy will be declared.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The OHCQ shall provide the freestanding birthing center with a written notice that includes a description of the situation that constitutes an immediate jeopardy.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Removal Plan.  The freestanding birthing center shall submit a written removal plan to the OHCQ that includes:</text>
      <paragraph num="(a)">
        <text>The immediate action a freestanding birthing center will take to prevent serious harm from occurring or recurring;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>All actions to remove past, present, and future jeopardy; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The date by which the freestanding birthing center asserts the likelihood for serious harm to any recipient no longer exists.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>OHCQ's Review of the Removal Plan.</text>
      <paragraph num="(a)">
        <text>The OHCQ shall review the freestanding birthing center's removal plan to determine that the removal plan, if implemented appropriately, will remove the likelihood that serious harm will occur, or recur.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The OHCQ shall verify that the freestanding birthing center has implemented the removal plan.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>OHCQ's Approval of the Removal Plan. The OHCQ shall approve the removal plan after verifying that all actions the freestanding birthing center took were effective in removing the likelihood that serious injury, serious harm, serious impairment or death would occur or reoccur.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Plan of Correction.  If an immediate jeopardy is identified during a survey, the Plan of Correction must completely correct all noncompliance associated with the immediate jeopardy.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>Informal Dispute Resolution (IDR).</text>
    <paragraph num="(1)">
      <text>A freestanding birthing center may request an IDR to dispute one or more deficiencies in a Statement of Deficiencies.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The freestanding birthing center shall submit the request for an IDR to the Department within 10 calendar days of receiving the Statement of Deficiencies.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The written request for an IDR shall fully describe the disagreement with the Statement of Deficiencies and be accompanied by all evidence for the Department’s consideration.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>At the discretion of the Department, the IDR may be held in person, by telephone, by video conference, or in writing.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>IDRs are informal in nature and are not attended by legal counsel representing the freestanding birthing center or the Department.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The IDR process may not delay the effective date of any enforcement action.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>In the event a freestanding birthing center requests an IDR of a deficiency written by a designee of the Department, the Department shall request the designee to participate in the IDR process.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>There is no appeal of the Department’s decision in an IDR.</text>
    </paragraph>
  </paragraph>
</regulation>