<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 10.21.16.08" title_num="10" subtitle_num="21" chapter_num="16" heading="Approval of a Program.">
  <paragraph num="A.">
    <text>Approval Without Conditions.</text>
    <paragraph num="(1)">
      <text>The Secretary shall grant approval without conditions to a program if, based on an on-site review, the Department's designated approval unit determines that the program complies with the requirements for approval.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Unless the program has been granted deemed status under Regulation .10 of this chapter, within not more than 3 years of the date of the program's last full on-site review, the Department's designated approval unit shall conduct a full, on-site review of the program.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Based on the review conducted under §A(2) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Approval with Conditions.</text>
    <paragraph num="(1)">
      <text>The Secretary may grant approval with conditions to a program if, based on an on-site review, the Department's designated approval unit determines that the program:</text>
      <paragraph num="(a)">
        <text>Is deficient in one or more of the requirements under this chapter, COMAR 10.21.17, or the chapter under the subtitle for the specific program;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Has no deficiencies that constitute a threat to health, safety, or welfare of the individuals served;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Has documented that the program will collaborate with the CSA, as required under COMAR 10.21.17.06; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Has submitted an acceptable program improvement plan within the time frame established under §B(3) of this regulation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>If the Secretary grants a program an approval with conditions under §B(1) of this regulation, the Secretary shall notify the program that the Department's designated approval unit may conduct a focused review under the provisions of §B(4) of this regulation.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Program Improvement Plan (PIP).</text>
      <paragraph num="(a)">
        <text>Within 10 working days of receipt of the list of deficiencies cited during the on-site review, the program director shall:</text>
        <paragraph num="(i)">
          <text>Submit a proposed PIP that addresses the identified deficiencies to the CSA or lead CSA; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Collaborate with the CSA or lead CSA to finalize the PIP.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Within 30 calendar days of receipt of the list of deficiencies cited during the on-site review, the program director shall submit:</text>
        <paragraph num="(i)">
          <text>The PIP to the Department's designated approval unit; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Documentation of the collaboration with the CSA or lead CSA.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Unless an extension has been granted by the Department's designated approval unit, if a program fails to submit a completed PIP within the time frames established in §B(3)(a) and (b) of this regulation, the Secretary may pursue disciplinary action under Regulation .12C of this chapter.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Focused Review.</text>
      <paragraph num="(a)">
        <text>For programs that have been granted approval with conditions, the Department's designated approval unit may conduct a focused review to:</text>
        <paragraph num="(i)">
          <text>Reevaluate the deficiencies cited during the on-site review conducted under §B(1) of this regulation; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Review the program's progress on the PIP.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Based on the focused review conducted under §B(4)(a) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Regular Program Review.</text>
      <paragraph num="(a)">
        <text>Within 3 years of the date of the program's last full on-site review, the Department's designated approval unit shall conduct a full, on-site review of the program.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Based on the review conducted under §B(5)(a) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Certificate of Approval.</text>
    <paragraph num="(1)">
      <text>If the Department's designated approval unit determines that a program is eligible for approval, the Secretary shall issue a certificate of approval to the program director that specifies the:</text>
      <paragraph num="(a)">
        <text>Chapter under which the program has been approved;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Type of approval; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Beginning and expiration dates of the approval period.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The Secretary shall notify the Administration, the CSA of the jurisdiction where the program provides services, the Medical Assistance Program, and the ASO of the program's approval.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The program director shall ensure that the certificate of approval is available during the regular hours of operation.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Sale or Transfer of Certificate of Approval.</text>
      <paragraph num="(a)">
        <text>The Secretary's certificate of approval of a program, issued according to the provisions of §C(1) of this regulation, is valid only for the program to which the Secretary's certificate of approval is issued.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A program may not sell, assign, or transfer a certificate of approval to another program.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Extension of Approval Status. The Secretary shall maintain the program's existing approval status if, before the expiration of approval period, the:</text>
    <paragraph num="(1)">
      <text>Department's designated approval unit does not complete an on-site review; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Department does not reach a decision regarding approval.</text>
    </paragraph>
  </paragraph>
</regulation>