<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.34.26.04" title_num="10" subtitle_num="34" chapter_num="26" heading="Ongoing Quality Assurance Program.">
  <paragraph num="A.">
    <text>A pharmacy permit holder shall establish and maintain an ongoing quality assurance program to:</text>
    <paragraph num="(1)">
      <text>Identify, investigate, and promote the prevention of medication errors; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Establish protocols and procedures to minimize the potential for medication errors.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The ongoing quality assurance program shall include the records, proceedings, files, and any other documents of the ongoing quality assurance program, including for each medication error:</text>
    <paragraph num="(1)">
      <text>The date of the error;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A brief description of the error;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The results of the evaluation by the ongoing quality assurance program's investigation; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Remedial action taken or recommendations.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Periodic Review.</text>
    <paragraph num="(1)">
      <text>A pharmacy permit holder shall analyze the records, proceedings, files, and any other documents of the ongoing quality assurance program required under §B of this regulation, including any medication errors relating to automated medication systems or unlicensed personnel, at least every 3 months as part of the periodic review that is required to maintain an ongoing quality assurance program.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Each pharmacy permit holder shall conduct an analysis of its medication delivery system at least every 6 months to determine which medications in the prescription area of the pharmacy are high-alert medications, as part of the pharmacy's ongoing quality assurance program.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Documentation of Periodic Review. The records, proceedings, files, and any other documents of the ongoing quality assurance program shall include for each:</text>
    <paragraph num="(1)">
      <text>Periodic review required under §C(1) of this regulation:</text>
      <paragraph num="(a)">
        <text>Documentation of the periodic review;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A description of the system's weaknesses found during the periodic review; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A description of the actions taken to remedy any weaknesses identified in the medication system; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Analysis of a pharmacy's medication delivery system to identify high-alert medications required under §C(2) of this regulation:</text>
      <paragraph num="(a)">
        <text>A list of high-alert medications present in the prescription area of the pharmacy;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The date that a high-alert medication was added to or removed from the list of high-alert medications;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Dates that the list was reviewed by the pharmacy permit holder; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Remedial actions taken based on the review of the list of high-alert medications and any medication errors relating to the high-alert medications.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Unless otherwise specified in law, the permit holder shall maintain the ongoing quality assurance program records referred to in this regulation for 2 years.</text>
  </paragraph>
  <paragraph num="F.">
    <text>The proceedings, records, and files of an ongoing quality assurance program that meets the requirements of Health Occupations Article, §1-401, Annotated Code of Maryland, and this chapter, are not discoverable and are not admissible in evidence in any civil action, as provided in Health Occupations Article, §1-401, Annotated Code of Maryland.</text>
  </paragraph>
</regulation>