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<regulation prefix="Regulation" num=".03" citation="COMAR 10.22.02.03" title_num="10" subtitle_num="22" chapter_num="02" heading="Investigation by the Administration.">
  <paragraph num="A.">
    <text>This regulation sets forth the roles of the Developmental Disabilities Administration and the Office of Health Care Quality in investigation and follow-up of reportable incidents.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Licensee to be Open for Inspection. A licensee shall be open at all reasonable times to announced and unannounced inspections by the Administration or its designee.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Records and Reports. A licensee shall maintain records and make reports as required by the Administration. The records and reports shall be open to inspection by the Administration. A licensee shall immediately, on request of the Administration, provide copies of the records and reports, including medical records of individuals, to the Administration.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Protocol to Determine Necessity to Investigate.</text>
    <paragraph num="(1)">
      <text>The Administration, through its agent, the Office of Health Care Quality (OHCQ), shall investigate reportable incidents, events, or problems involving individuals in a community agency or State residential center based on the scope and severity in accordance with the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The licensee shall report incidents in accordance with the requirements and timelines outlined in the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The necessity for investigation is determined by the following priorities:</text>
      <paragraph num="(a)">
        <text>Priority Level 1 — Immediate Jeopardy — Initiate investigation within 2 working days of receipt;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Priority Level 2 — High—Initiate investigation within 4 working days of receipt;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Priority Level 3 — Other Harm — Initiate an investigation within 30 working days of receipt;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Priority Level 4 — Administrative Review — Review during preparation for licensee's annual survey;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Priority Level 5 — Referrals — Refer to internal OHCQ unit or appropriate agency for follow-up within 1 working day; or</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Priority Level 6 — Death — Upon notification, refer to the Mortality Review Unit of OHCQ within 1 working day for review and investigation.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Timelines for Specific Reports and Follow-Up Protocols.</text>
      <paragraph num="(a)">
        <text>The licensee shall submit a plan of correction (POC) within 10 working days of the receipt of deficiencies. The POC due date may be sooner than 10 working days when the nature of the deficiency warrants a more immediate response, as determined by the OHCQ and as outlined in Appendix 6 of the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>If the POC is determined to be acceptable, the OHCQ shall, whenever possible, within 10 working days of approving the POC, send the statement of deficiency and the POC to the:</text>
        <paragraph num="(i)">
          <text>Licensee who is required to share this information with the individual receiving services, who is the specific subject of a deficient practice, or to the resource coordinator, a guardian, or a family member as appropriate and set forth in the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Complainant;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Agency's Executive Director and Board President;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>DDA Regional Office;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Maryland Disability Law Center when required by Developmental Disabilities Administration Policy on Reportable Incidents and Investigations;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Medicaid Fraud Control Unit of the Attorney General's Office when required by Developmental Disabilities Administration Policy on Reportable Incidents and Investigations; and</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Any other parties determined to be appropriate by OHCQ.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>If the POC is determined to be unacceptable, the OHCQ shall, whenever possible, notify the agency in writing within 5 working days of receipt of the issues which require further review and consideration. The licensee shall resubmit to OHCQ a revised POC within 5 working days from notification of an unacceptable POC.</text>
      </paragraph>
      <paragraph num="(d)">
        <text>OHCQ shall conduct follow-up monitoring in accordance with Developmental Disabilities Administration Policy on Reportable Incidents and Investigations.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Methods of Investigation. OHCQ shall conduct investigations through:</text>
    <paragraph num="(1)">
      <text>On-site inspections;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Interviews; or</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Reviews of relevant records and documents.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>The licensee and OHCQ may receive extensions of the time periods set forth in this regulation for good cause shown.</text>
  </paragraph>
</regulation>