<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.34.35.06" title_num="10" subtitle_num="34" chapter_num="35" heading="Minimum Requirements for Policies and Procedures.">
  <text>The policies and procedures shall:</text>
  <paragraph num="A.">
    <text>Be congruent with State regulations and standards of care from accrediting bodies and professional organizations; and</text>
  </paragraph>
  <paragraph num="B.">
    <text>Address:</text>
    <paragraph num="(1)">
      <text>Personnel:</text>
      <paragraph num="(a)">
        <text>Training and Orientation;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Duties; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Qualifications;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Security of the facility;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Standards of patient care;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Infection control;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Initial and ongoing home safety assessments;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The provision of patient or caregiver education including, but not limited to:</text>
      <paragraph num="(a)">
        <text>Drug and therapy administration-specific information and precautions;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Reporting adverse drug reactions;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Reporting side effects;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Infusion pharmacy contact information;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Emergency measures related to:</text>
        <paragraph num="(i)">
          <text>Changes in patient condition requiring medical intervention; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Events which may delay or prevent delivery of pharmaceuticals or nursing care; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(f)">
        <text>Equipment use and safety.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(7)">
      <text>Patient care operations, including but not limited to:</text>
      <paragraph num="(a)">
        <text>If applicable, pharmacist checking procedures related to order entry and compounding accuracy;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Therapy-specific monitoring parameters for:</text>
        <paragraph num="(i)">
          <text>Laboratory testing;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Appropriate frequency of testing; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Patient follow-up; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Pump, or other patient-use equipment, between-patient cleaning, testing, and preventive maintenance, which include specific:</text>
        <paragraph num="(i)">
          <text>Procedures and documentation of cleaning, testing and preventive maintenance for patient equipment according to manufacturer’s guidelines; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Frequencies for all equipment maintenance activities;</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(8)">
      <text>Delivery arrangements;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Patient confidentiality and the Health Insurance Portability and Accountability Act, 45 CFR Parts 160 and 164; and</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Availability of a pharmacist on call after-hours to respond to:</text>
      <paragraph num="(a)">
        <text>Pharmacy related patient or caregiver inquiries; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Medication or supply needs.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>