<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 10.07.05.08" title_num="10" subtitle_num="07" chapter_num="05" heading="Administration.">
  <paragraph num="A.">
    <text>Governing Authority.</text>
    <paragraph num="(1)">
      <text>The agency shall have a governing authority.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The governing authority shall:</text>
      <paragraph num="(a)">
        <text>Convene at least annually with management staff to review and advise the agency on policies; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Keep minutes, including:</text>
        <paragraph num="(i)">
          <text>The participants of any meeting;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Agenda items considered; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Actions taken.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Policies and Procedures.</text>
    <paragraph num="(1)">
      <text>An agency shall develop and implement policies and procedures, including but not limited to:</text>
      <paragraph num="(a)">
        <text>Administration, including:</text>
        <paragraph num="(i)">
          <text>Scope of services;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Delineation of services provided by the agency when the agency coordinates care within the agency or with another provider;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Notification to the client or client representative with legal authority to make health care decisions of the agency’s responsibilities to coordinate care when appropriate;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Admission criteria;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Assessment of potential clients before their acceptance into the program;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Billing and service records, maintenance of charges, and similar items, except for those clients receiving services through a managed-care health benefits plan or third party payor, in which case records are maintained as required by the third party payor;</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Quality assurance program; and</text>
        </paragraph>
        <paragraph num="(viii)">
          <text>Clinical management, including assessment, plans, delegation, and supervision;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Personnel, including:</text>
        <paragraph num="(i)">
          <text>Job descriptions and educational qualifications for all employees and contractors;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Skill assessments of all employees and contractors; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Health requirements for employees and contractors;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Patient care, including:</text>
        <paragraph num="(i)">
          <text>Provision of home health care services and criteria for determining the need for skilled services;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Administration of drugs;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Enteral and parenteral nutrition procedures;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Frequency of client monitoring; and</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Training and retraining of clients or their family members, when indicated;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>Informed consent when:</text>
        <paragraph num="(i)">
          <text>A client or client representative with legal authority to make legal decisions, signs an informed consent form consenting to changes to the agency’s recommended plan of care; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>A client signs an informed consent form consenting to assistance by a nonlicensed individual with treatments of a routine nature, or with the self-administration of medications; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(e)">
        <text>Environment and safety, including:</text>
        <paragraph num="(i)">
          <text>Preparation and storage of enteral formulas, intravenous therapies, other supplies, equipment, and similar items;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Infection control procedures;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Disposal of biomedical waste;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Maintenance of equipment; and</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Emergency procedures.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The Department may waive the requirement of a policy and procedure that is required in §B of this regulation upon the agency’s written explanation as to why the policy and procedure is inappropriate or unnecessary to the agency’s specific operation.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>An agency that provides invasive equipment or supplies, such as intravenous therapy, shall arrange for 24-hour-a-day equipment maintenance service in case of equipment failure.</text>
    </paragraph>
  </paragraph>
</regulation>