<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.50.01.06" title_num="10" subtitle_num="50" chapter_num="01" heading="Permitting Procedure.">
  <paragraph num="A.">
    <text>Application. An application is not complete until the OHCQ has received the completed permit application and all required documents.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Initial Inspection. The OHCQ shall inspect or have an inspection conducted by an accreditation organization for each tissue bank when an initial Maryland permit to operate is sought.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Issuance of a Permit. The Secretary shall issue a permit to an applicant who meets the requirements of this chapter to:</text>
    <paragraph num="(1)">
      <text>Operate a tissue bank in the State; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Represent for service in the State a tissue bank that is inside the State or outside the State.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Issuance of a Permit and Provisional Permit.</text>
    <paragraph num="(1)">
      <text>Permit and Provisional Permit Content. A permit and provisional permit shall state:</text>
      <paragraph num="(a)">
        <text>The name of the tissue bank;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The name of the tissue bank's medical director;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The name of the tissue bank's owner or owners; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The class or classes of the tissue bank.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Provisional Permit.</text>
      <paragraph num="(a)">
        <text>The Secretary may issue a provisional permit before or after an initial inspection.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A provisional permit:</text>
        <paragraph num="(i)">
          <text>Is valid for 180 calendar days or a lesser period as determined by the Secretary;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>May not be renewed; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Shall automatically expire without notice upon the sooner of the date set for its expiration or upon issuance of a permit.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Permit Requirement. A person shall hold a permit issued by the Secretary before the person may:</text>
    <paragraph num="(1)">
      <text>Operate a tissue bank in this State; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Represent or service in this State a tissue bank that is:</text>
      <paragraph num="(a)">
        <text>In this State; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Outside this State.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Operating Without a Permit.</text>
    <paragraph num="(1)">
      <text>Unless a person has a permit issued by the Secretary to operate, represent, or service a tissue bank in this State, a person may not:</text>
      <paragraph num="(a)">
        <text>Operate a tissue bank in this State; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Represent or service in this State a tissue bank that is in this State or outside this State.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A permit holder may not operate, represent, or service a tissue bank class other than that authorized in the permit.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>Cessation of Operations.  If a tissue bank ceases operation for 180 calendar days, then:</text>
    <paragraph num="(1)">
      <text>The OHCQ will void the permit to operate a tissue bank in the State; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The tissue bank shall return the permit to the OHCQ.</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>Permit Application Administratively Closed.</text>
    <paragraph num="(1)">
      <text>After 180 calendar days from the date of initial receipt, the OHCQ may deem an incomplete permit application inactive and administratively close the application.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>An applicant whose application is administratively closed may reapply for a permit by submitting a new application.</text>
    </paragraph>
  </paragraph>
  <paragraph num="I.">
    <text>Change of Medical Director, Name, or Location of a Tissue Bank. A tissue bank undergoing a change in medical director, name, or location shall:</text>
    <paragraph num="(1)">
      <text>Notify the OHCQ 10 calendar days before a change occurs; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Apply to the OHCQ for an amended permit or provisional permit within 30 calendar days after a change takes place.</text>
    </paragraph>
  </paragraph>
  <paragraph num="J.">
    <text>Nontransferability. A permit or provisional permit may not be transferred from one owner of a tissue bank to another.</text>
  </paragraph>
  <paragraph num="K.">
    <text>Denial, Suspension, Revocation — Causes. The Secretary may deny, suspend, or revoke a permit or provisional permit if the tissue bank or the tissue bank's technical director, medical director, or both fail to meet requirements of this chapter, including, but not limited to:</text>
    <paragraph num="(1)">
      <text>Failure within a specified time to correct a cited deficiency identified during an inspection;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Repetitive or consistent errors;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Deliberate falsehood; or</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Failure to apply for an amended permit or provisional permit within 30 calendar days after a tissue bank undergoes a change in tissue bank class, medical director, name, or location.</text>
    </paragraph>
  </paragraph>
  <paragraph num="L.">
    <text>Denial, Suspension, and Revocation — Hearing Requirement.</text>
    <paragraph num="(1)">
      <text>When the Secretary denies an application for a permit, the Secretary shall inform the permit applicant in writing:</text>
      <paragraph num="(a)">
        <text>Of the date the denial takes effect;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Of the reason for the denial; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>That the permit applicant has an opportunity for a hearing on the matter in accordance with State Government Article, §10-226, Annotated Code of Maryland.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Unless the Secretary finds that a danger to public health, safety, or welfare summarily requires that emergency action be taken to correct a deficiency, the Secretary shall inform the permit holder or provisional permit holder, in writing:</text>
      <paragraph num="(a)">
        <text>Of the date a suspension or revocation of the permit or provisional permit takes effect;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Of the reason for the suspension or revocation; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>That the permit holder or provisional permit holder has an opportunity for a hearing on the matter before the suspension or revocation takes effect, in accordance with State Government Article, §10-226, Annotated Code of Maryland.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>When a finding is made that the public health, safety, or welfare summarily requires that emergency or immediate corrective action be taken, the Secretary shall inform the permit holder or provisional permit holder in writing:</text>
      <paragraph num="(a)">
        <text>Of the date a suspension or revocation of the permit or provisional permit takes effect;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Of the reason for the suspension or revocation; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>That the permit holder or provisional permit holder has an opportunity for a hearing on the matter, after the suspension or revocation takes effect, in accordance with State Government Article, §10-226, Annotated Code of Maryland.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Reapplication After Revocation. A tissue bank that has had its permit or provisional permit revoked may apply for a new permit 30 calendar days after revocation and upon presentation to the Secretary of evidence of capability and intention to comply with the standards and requirements of this chapter.</text>
    </paragraph>
  </paragraph>
  <paragraph num="M.">
    <text>Return of Permit. If a tissue bank's permit is amended, suspended, or revoked, the original permit is void and the tissue bank's technical director shall return the permit to the OHCQ.</text>
  </paragraph>
</regulation>