HL7 Electronic Health Record System Functional Model, Release 2.1.1
2.1.1 - Normative

HL7 Electronic Health Record System Functional Model, Release 2.1.1, published by HL7 International / Electronic Health Records. This guide is not an authorized publication; it is the continuous build for version 2.1.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ehrsfm-ig/ and changes regularly. See the Directory of published versions

## : CP.1.6 Manage Immunization List (Function)

Page standards status: Normative

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    <Requirements xmlns="http://hl7.org/fhir">
      <id value="EHRSFMR2-CP.1.6"/>
      <meta>
        <profile
                 value="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/FMFunction"/>
      </meta>
      <language value="en"/>
      <text>
        <status value="extensions"/>
        <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en">

        <div id="description"><b>Description <a href="https://hl7.org/fhir/versions.html#std-process" title="Informative Content" class="informative-flag">I</a>:</b> <div><p>Immunization lists are managed over time, whether over the course of a visit or stay, or the lifetime of a patient. Details of immunizations administered are captured as discrete data elements including date, type, manufacturer and lot number. The entire immunization history is viewable.</p>
    </div></div>

        <div id="requirements"><b>Criteria <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b></div>

        <table id="statements" class="grid dict">

            <tr>
                <td style="padding-left: 4px;">
                CP.1.6#01
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD provide the ability to manage all immunizations associated with a patient.</p>
    </div>
                    Satisfied by:<ol>
                    <li><a href="https://hl7.org/fhir/immunization.html">https://hl7.org/fhir/immunization.html</a></li>
                    </ol>
                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CP.1.6#02
                </td>
                <td style="padding-left: 4px;">
                SHOULD

                    <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #e5f5e5;color: #388e3c;border: 1px solid #a2d1a2;">dependent</span>

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHOULD provide the ability to maintain immunization details, as discrete data, including:</p>
    <ul>
    <li>the immunization name/type, seqeunce number in the series &amp; series identifier, strength and dose;</li>
    <li>the date and time of administration;</li>
    <li>manufacturer, lot number, expiration date,</li>
    <li>route and site of administration;</li>
    <li>administering provider;</li>
    <li>observations, reactions and complications;</li>
    <li>reason immunization not given, and/or immunization related activity not performed;
    according to scope of practice, organizational policy, and/or jurisdictional law.</li>
    </ul>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CP.1.6#03
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL provide the ability to manage, as discrete elements, data associated with an immunization that was not given to a patient (e.g., due to a contraindication or a patient's refusal). Data associated with an immunization that was not given to a patient includes date-and-time, immunization type, series, exception reason, and immunization-withholding provider.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CP.1.6#04
                </td>
                <td style="padding-left: 4px;">
                SHALL

                    <span style="border-radius: 999px;margin: 2px 2px;font-size: 10px;display: inline-block;padding: 3px 5px;letter-spacing: 0.5px;line-height: 1;white-space: nowrap;background-color: #e5f5e5;color: #388e3c;border: 1px solid #a2d1a2;">dependent</span>

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL provide the ability to render (e.g., print or transmit) a report of a patient's immunization history (e.g., for appropriate authorities such as schools, day-care centers or public health immunization registries) according to scope of practice, organizational policy, and/or jurisdictional law.</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CP.1.6#05
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL provide the ability to capture the currently recommended date for a companion immunization (e.g., a subsequent or booster dose) with each immunization (if such a companion immunization is needed).</p>
    </div>

                </td>
            </tr>

            <tr>
                <td style="padding-left: 4px;">
                CP.1.6#06
                </td>
                <td style="padding-left: 4px;">
                SHALL

                </td>
                <td style="padding-left: 4px;" class="requirement">
                    <div><p>The system SHALL provide the ability to capture, maintain and render population-based immunization schedules from relevant public health immunization authorities (e.g., CDC for US realm).</p>
    </div>

                </td>
            </tr>

        </table>
    </div>
      </text>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
        <valueCode value="normative"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
        <valueCode value="ehr"/>
      </extension>
      <url value="http://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-CP.1.6"/>
      <version value="2.1.1"/>
      <name value="CP_1_6_Manage_Immunization_List"/>
      <title value="CP.1.6 Manage Immunization List (Function)"/>
      <status value="active"/>
      <date value="2025-12-13T09:06:06+00:00"/>
      <publisher value="HL7 International / Electronic Health Records"/>
      <contact>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/ehr"/>
        </telecom>
      </contact>
      <description
                   value="Create and maintain patient-specific immunization lists."/>
      <jurisdiction>
        <coding>
          <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
          <code value="001"/>
          <display value="World"/>
        </coding>
      </jurisdiction>
      <purpose
               value="Immunization lists are managed over time, whether over the course of a visit or stay, or the lifetime of a patient. Details of immunizations administered are captured as discrete data elements including date, type, manufacturer and lot number. The entire immunization history is viewable."/>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CP.1.6-01"/>
        <label value="CP.1.6#01"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHOULD provide the ability to manage all immunizations associated with a patient."/>
        <derivedFrom value="EHR-S_FM_R1.1 DC.1.4.4#1"/>
        <satisfiedBy value="https://hl7.org/fhir/immunization.html"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
        </extension>
        <key value="EHRSFMR2-CP.1.6-02"/>
        <label value="CP.1.6#02"/>
        <conformance value="SHOULD"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHOULD provide the ability to maintain immunization details, as discrete data, including:
    - the immunization name/type, seqeunce number in the series &amp; series identifier, strength and dose;
    - the date and time of administration;
    - manufacturer, lot number, expiration date,
    - route and site of administration;
    - administering provider;
    - observations, reactions and complications;
    - reason immunization not given, and/or immunization related activity not performed;
    according to scope of practice, organizational policy, and/or jurisdictional law."/>
        <derivedFrom value="EHR-S_FM_R1.1 DC.1.4.4#2"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CP.1.6-03"/>
        <label value="CP.1.6#03"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL provide the ability to manage, as discrete elements, data associated with an immunization that was not given to a patient (e.g., due to a contraindication or a patient's refusal). Data associated with an immunization that was not given to a patient includes date-and-time, immunization type, series, exception reason, and immunization-withholding provider."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="true"/>
        </extension>
        <key value="EHRSFMR2-CP.1.6-04"/>
        <label value="CP.1.6#04"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL provide the ability to render (e.g., print or transmit) a report of a patient's immunization history (e.g., for appropriate authorities such as schools, day-care centers or public health immunization registries) according to scope of practice, organizational policy, and/or jurisdictional law."/>
        <derivedFrom value="EHR-S_FM_R1.1 DC.1.4.4#3"/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CP.1.6-05"/>
        <label value="CP.1.6#05"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL provide the ability to capture the currently recommended date for a companion immunization (e.g., a subsequent or booster dose) with each immunization (if such a companion immunization is needed)."/>
      </statement>
      <statement>
        <extension
                   url="http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent">
          <valueBoolean value="false"/>
        </extension>
        <key value="EHRSFMR2-CP.1.6-06"/>
        <label value="CP.1.6#06"/>
        <conformance value="SHALL"/>
        <conditionality value="false"/>
        <requirement
                     value="The system SHALL provide the ability to capture, maintain and render population-based immunization schedules from relevant public health immunization authorities (e.g., CDC for US realm)."/>
      </statement>
    </Requirements>