ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - local
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| Active as of 2024-11-26 |
<Requirements xmlns="http://hl7.org/fhir">
<id value="EHRSFMR2.1-CPS.3.3"/>
<meta>
<profile value="http://hl7.org/ehrs/StructureDefinition/FMFunction"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<span id="description"><b>Statement <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b> <div><p>Support the use of appropriate standard care plans, guidelines, protocols, and/or clinical pathways for the management of specific conditions.</p>
</div></span>
<span id="purpose"><b>Description <a href="https://hl7.org/fhir/versions.html#std-process" title="Informative Content" class="informative-flag">I</a>:</b> <div><p>A core capability of Clinical Decision Support is that of providing guidelines, plans and protocols to clinicians. These templates or forms can be specific for populations, medical conditions or individual patients. Before they can be used in care provision standard care plans, guidelines, protocols, and clinical pathways must be created. These templates or forms may reside within the system or be provided through links to external sources, and can be modified and used on a site specific basis. To facilitate retrospective decision support, variances from standard care plans, guidelines, protocols and clinical pathways can be identified and reported.</p>
</div></span>
<span id="requirements"><b>Criteria <a href="https://hl7.org/fhir/versions.html#std-process" title="Normative Content" class="normative-flag">N</a>:</b></span>
<table id="statements" class="grid dict">
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#01</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to capture and maintain site-specific care plans, guidelines, protocols, and clinical pathways.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#02</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to maintain site-specific modifications to standard care plans, guidelines, protocols, and clinical pathways obtained from outside sources.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#03</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD determine variances from standard care plans, guidelines, protocols, and clinical pathways and provide the ability to capture, maintain and render appropriate alerts, notifications and reports.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#04</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD determine variances from standard care plans, guidelines and protocols for reportable conditions and provide the ability to capture, maintain and transmit related information to public health.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#05</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD conform to function [[POP.4]] (Support for Monitoring Response Notifications Regarding a Specific Patient's Health).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#06</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function [[CPS.3.4]] (Support for Context-Sensitive Care Plans, Guidelines, Protocols).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#07</span>
</td>
<td style="padding-left: 4px;">
<span>SHALL</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHALL conform to function [[CPS.3.1]] (Support for Standard Assessments).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#08</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to capture, maintain and render condition-specific guidelines (e.g., based on age or weight).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#09</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to capture documents using standards-based documentation templates to support data exchanges.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#10</span>
</td>
<td style="padding-left: 4px;">
<span>MAY</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system MAY provide the ability to maintain standard choices for disposition (e.g., reviewed and filed, recall patient, or future follow-up).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#11</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to manage patient disposition status configuration parameters.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#12</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to tag and render an indicator that a patient record is incomplete (e.g., not finalized or authenticated/signed).</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#13</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD provide the ability to render an indicator that a patient record is incomplete (e.g., not finalized or authenticated/signed) when a discharge or transfer order is entered into the system.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#14</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD tag specific missing elements/sections of incomplete records.</p>
</div></span>
</td>
</tr>
<tr>
<td style="padding-left: 4px;">
<span>CPS.3.3#15</span>
</td>
<td style="padding-left: 4px;">
<span>SHOULD</span>
</td>
<td style="padding-left: 4px;" class="requirement">
<span><div><p>The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation.</p>
</div></span>
</td>
</tr>
</table>
</div>
</text>
<url value="http://hl7.org/ehrs/Requirements/EHRSFMR2.1-CPS.3.3"/>
<version value="2.1.0"/>
<name
value="CPS_3_3_Support_for_Standard_Care_Plans__Guidelines__Protocols"/>
<title
value="CPS.3.3 Support for Standard Care Plans, Guidelines, Protocols (Function)"/>
<status value="active"/>
<date value="2024-11-26T16:30:50+00:00"/>
<publisher value="EHR WG"/>
<contact>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/ehr"/>
</telecom>
</contact>
<description
value="Support the use of appropriate standard care plans, guidelines, protocols, and/or clinical pathways for the management of specific conditions."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<purpose
value="A core capability of Clinical Decision Support is that of providing guidelines, plans and protocols to clinicians. These templates or forms can be specific for populations, medical conditions or individual patients. Before they can be used in care provision standard care plans, guidelines, protocols, and clinical pathways must be created. These templates or forms may reside within the system or be provided through links to external sources, and can be modified and used on a site specific basis. To facilitate retrospective decision support, variances from standard care plans, guidelines, protocols and clinical pathways can be identified and reported."/>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-01"/>
<label value="CPS.3.3#01"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture and maintain site-specific care plans, guidelines, protocols, and clinical pathways."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.2.2.1.1#2"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-02"/>
<label value="CPS.3.3#02"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to maintain site-specific modifications to standard care plans, guidelines, protocols, and clinical pathways obtained from outside sources."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.2.2.1.1#3"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-03"/>
<label value="CPS.3.3#03"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD determine variances from standard care plans, guidelines, protocols, and clinical pathways and provide the ability to capture, maintain and render appropriate alerts, notifications and reports."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.2.2.1.1#4"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-04"/>
<label value="CPS.3.3#04"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD determine variances from standard care plans, guidelines and protocols for reportable conditions and provide the ability to capture, maintain and transmit related information to public health."/>
<derivedFrom value="PHFP DC.2.2.1.1#8"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-05"/>
<label value="CPS.3.3#05"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD conform to function [[POP.4]] (Support for Monitoring Response Notifications Regarding a Specific Patient's Health)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-06"/>
<label value="CPS.3.3#06"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL conform to function [[CPS.3.4]] (Support for Context-Sensitive Care Plans, Guidelines, Protocols)."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.2.2.1.1#5"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-07"/>
<label value="CPS.3.3#07"/>
<conformance value="SHALL"/>
<conditionality value="false"/>
<requirement
value="The system SHALL conform to function [[CPS.3.1]] (Support for Standard Assessments)."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.2.2.1.1#6"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-08"/>
<label value="CPS.3.3#08"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture, maintain and render condition-specific guidelines (e.g., based on age or weight)."/>
<derivedFrom value="PHFP DC.2.2.1.1#7"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-09"/>
<label value="CPS.3.3#09"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to capture documents using standards-based documentation templates to support data exchanges."/>
<derivedFrom value="EHR-S_FM_R1.1 DC.1.8.5#12"/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-10"/>
<label value="CPS.3.3#10"/>
<conformance value="MAY"/>
<conditionality value="false"/>
<requirement
value="The system MAY provide the ability to maintain standard choices for disposition (e.g., reviewed and filed, recall patient, or future follow-up)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-11"/>
<label value="CPS.3.3#11"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to manage patient disposition status configuration parameters."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-12"/>
<label value="CPS.3.3#12"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to tag and render an indicator that a patient record is incomplete (e.g., not finalized or authenticated/signed)."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-13"/>
<label value="CPS.3.3#13"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD provide the ability to render an indicator that a patient record is incomplete (e.g., not finalized or authenticated/signed) when a discharge or transfer order is entered into the system."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-14"/>
<label value="CPS.3.3#14"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD tag specific missing elements/sections of incomplete records."/>
</statement>
<statement>
<extension
url="http://hl7.org/ehrs/StructureDefinition/requirements-dependent">
<valueBoolean value="false"/>
</extension>
<key value="EHRSFMR2.1-CPS.3.3-15"/>
<label value="CPS.3.3#15"/>
<conformance value="SHOULD"/>
<conditionality value="false"/>
<requirement
value="The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation."/>
</statement>
</Requirements>