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<regulation prefix="Regulation" num=".05" citation="COMAR 09.12.22.05" title_num="09" subtitle_num="12" chapter_num="22" heading="Written Access Orders.">
  <paragraph num="A.">
    <text>Requirements.</text>
    <paragraph num="(1)">
      <text>Except as provided in §D of this regulation, a request by a MOSH representative to examine or copy personally identifiable employee medical information contained in a record held by an employer or other record holder shall be made in accordance with a written access order approved by the Commissioner or the Commissioner's authorized representative upon the recommendation of the medical records officer.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>At the Commissioner's discretion, a written access order may constitute, or be accompanied by, an administrative subpoena.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Approval Criteria. Before issuing a written access order, the Commissioner or the Commissioner's authorized representative and the medical records officer shall determine that:</text>
    <paragraph num="(1)">
      <text>The medical information to be examined or copied is relevant to a statutory purpose;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>There is a need to gain access to the personally identifiable information;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The personally identifiable medical information to be examined or copied is limited to only the information needed to accomplish the purpose for access; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The personnel authorized to review and analyze the personally identifiable medical information are limited to those who have need for access and who have appropriate professional qualifications.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Content. A written access order shall state with reasonable particularity:</text>
    <paragraph num="(1)">
      <text>The statutory purposes for which access is sought;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A general description of the kind of employee medical information that will be examined;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>An explanation of the need to examine personally identifiable employee medical information;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Whether medical information will be examined onsite;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>What type of information will be copied and removed offsite;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The name, address, and telephone number of the principal investigator and medical records officer;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>The name of any other authorized individual who is expected to review and analyze the medical information; and</text>
    </paragraph>
    <paragraph num="(8)">
      <text>The anticipated period of time during which the employee medical information in a personally identifiable form is expected to be retained.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Special Situations Not Requiring a Written Access Order.</text>
    <paragraph num="(1)">
      <text>MOSH personnel are permitted to examine or copy personally identifiable employee medical information without a written access order if:</text>
      <paragraph num="(a)">
        <text>The specific written consent of an employee is obtained under 29 CFR §1910.1020(e)(2)(ii), and MOSH or a MOSH employee is listed on the authorization as the designated representative to receive the medical information;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>When the information is taken offsite, the Commissioner or the Commissioner's authorized representative promptly:</text>
        <paragraph num="(i)">
          <text>Names a principal investigator to ensure protection of the information, and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Notifies the medical records officer of the principal investigator's identity; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>MOSH handles the personally identifiable medical information in accordance with the use and security requirements of Regulations .06 and .07 of this chapter.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>MOSH Physician.</text>
      <paragraph num="(a)">
        <text>A MOSH staff or contract physician shall be accorded access to personally identifiable employee medical information without a written access order, if the MOSH staff or contract physician:</text>
        <paragraph num="(i)">
          <text>Is consulting with an employer's physician concerning an occupational safety or health issue;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Conducts an on-site evaluation of employee medical records in consultation with the employer's physician; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Makes only necessary personal notes of the MOSH staff or contract physician's findings.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Employee medical records may not be taken offsite in the absence of a written access order or the specific written consent of an employee.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Notes of personally identifiable employee medical information made by the MOSH physician may not leave the physician's control without the permission of the medical records officer.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Procedure for Presentation of Written Access Order.</text>
    <paragraph num="(1)">
      <text>Presentation to Employer.</text>
      <paragraph num="(a)">
        <text>Before examining or obtaining medical information subject to a written access order, the principal investigator, or a MOSH employee under the investigator's supervision, shall present to the employer:</text>
        <paragraph num="(i)">
          <text>At least two copies of the written access order; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>An accompanying cover letter to the employer.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>At least one copy of the written access order may not identify specific employees by direct personal identifier.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The accompanying cover letter shall:</text>
        <paragraph num="(i)">
          <text>Summarize the requirements of this section; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Indicate that questions or objections concerning the written access order may be directed to the principal investigator or to the medical records officer.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>The employer shall post promptly:</text>
        <paragraph num="(i)">
          <text>A copy of the written access order which does not identify specific employees by direct personal identifier; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The accompanying cover letter.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Presentation to Collective Bargaining Agent. The principal investigator shall present promptly to each collective bargaining agent representing employees whose medical records are subject to the written access order:</text>
      <paragraph num="(a)">
        <text>A copy of the written access order which does not identify specific employees by direct personal identifier; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The accompanying cover letter.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Notice to Employees.</text>
      <paragraph num="(a)">
        <text>After presentation of a written access order to an employer and a collective bargaining agent, if any, the principal investigator shall:</text>
        <paragraph num="(i)">
          <text>Discuss with the collective bargaining agent, if any, and the employer whether to provide individual notice to employees affected by the written access order; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>If it is agreed that individual notice is appropriate, provide the employer an adequate number of copies of the written access order which does not identify specific employees by direct personal identifier, and the accompanying cover letter.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>An employer shall notify each affected employee by delivering the written access order or by placing a copy in each employee's medical file.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Objections Concerning a Written Access Order.</text>
    <paragraph num="(1)">
      <text>An employee, collective bargaining agent, and employer may file a written objection to access to records under a written access order.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A written objection shall be transmitted to the medical records officer.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Unless the Commissioner or the Commissioner's authorized representative decides otherwise, access to the records shall proceed without delay, notwithstanding the filing of an objection.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The medical records officer shall respond in writing to a written objection to access by MOSH.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>If appropriate, the medical records officer may:</text>
      <paragraph num="(a)">
        <text>Revoke a written access order; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Direct that the medical information obtained under the revoked written access order be returned to the original record holder, or destroyed.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>The principal investigator shall ensure that the instructions by the medical records officer are promptly implemented.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>Removal of Direct Personal Identifiers.</text>
    <paragraph num="(1)">
      <text>If employee medical information obtained under a written access order is taken offsite with direct personal identifiers included, and the investigator is not otherwise authorized by the medical records officer, the principal investigator shall:</text>
      <paragraph num="(a)">
        <text>Separate promptly all direct personal identifiers from the medical information; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Code the medical information and the list of direct identifiers with a unique identifier for each employee.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The medical information with the code shall be used and kept secured as though still in a directly identifiable form.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The principal investigator shall hand deliver or mail the list of direct personal identifiers with corresponding codes to the medical records officer.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The medical records officer shall limit the use and distribution of the list of coded identifiers to individuals with a need to know its contents.</text>
    </paragraph>
  </paragraph>
</regulation>