# C-CDA: Results Section

## Overview

The Results Section documents observations generated by clinical investigations including laboratory analyses, imaging procedures, and procedural findings. It encompasses observations across multiple disciplines: hematology, chemistry, serology, virology, toxicology, microbiology, plain x-ray, ultrasound, CT, MRI, angiography, echocardiography, nuclear medicine, pathology, and procedure observations. The section may include notable results (abnormal values, relevant trends) and supports subsectioning by category using LOINC codes.

## Template Information

| Attribute | Value |
|-----------|-------|
| Template ID (entries required) | `2.16.840.1.113883.10.20.22.2.3.1` |
| Template ID (entries optional) | `2.16.840.1.113883.10.20.22.2.3` |
| Extension | 2015-08-01 |
| Version | 5.0.0-ballot (STU5) |
| URL | `http://hl7.org/cda/us/ccda/StructureDefinition/ResultsSection` |
| LOINC Code | 30954-2 |
| LOINC Display | Relevant diagnostic tests/laboratory data Narrative |
| Code System | 2.16.840.1.113883.6.1 (LOINC) |

## Location in Document

```
ClinicalDocument
└── component
    └── structuredBody
        └── component
            └── section [Results Section]
                ├── templateId [@root='2.16.840.1.113883.10.20.22.2.3.1']
                ├── code [@code='30954-2']
                ├── title
                ├── text (narrative)
                └── entry
                    └── organizer [Result Organizer]
                        └── component
                            └── observation [Result Observation]
```

## Purpose & Scope

The Results Section is a required component in many C-CDA document types for conveying diagnostic test results. It provides:

1. Grouping mechanism for related laboratory tests, imaging findings, and diagnostic observations
2. Support for both structured data (via Result Organizers and Observations) and narrative text
3. Subsectioning capability for organizing results by service category (e.g., laboratory, radiology)
4. USCDI data element representation for laboratory results and imaging findings

## XML Structure

### Complete Results Section Example

```xml
<section>
  <!-- Template ID (entries required) -->
  <templateId root="2.16.840.1.113883.10.20.22.2.3.1" extension="2015-08-01"/>

  <!-- Section Code -->
  <code code="30954-2"
        codeSystem="2.16.840.1.113883.6.1"
        codeSystemName="LOINC"
        displayName="Relevant diagnostic tests/laboratory data Narrative"/>

  <!-- Section Title -->
  <title>RESULTS</title>

  <!-- Narrative Text -->
  <text>
    <table border="1" width="100%">
      <thead>
        <tr>
          <th>Test</th>
          <th>Result</th>
          <th>Units</th>
          <th>Reference Range</th>
          <th>Interpretation</th>
          <th>Date</th>
        </tr>
      </thead>
      <tbody>
        <tr>
          <td colspan="6"><content styleCode="Bold">Complete Blood Count (March 1, 2020)</content></td>
        </tr>
        <tr>
          <td ID="result1">Hemoglobin</td>
          <td>13.2</td>
          <td>g/dL</td>
          <td>12.0-16.0</td>
          <td>Normal</td>
          <td>March 1, 2020</td>
        </tr>
        <tr>
          <td ID="result2">White Blood Cell Count</td>
          <td>6.7</td>
          <td>10*9/L</td>
          <td>4.3-10.8</td>
          <td>Normal</td>
          <td>March 1, 2020</td>
        </tr>
        <tr>
          <td ID="result3">Platelet Count</td>
          <td>250</td>
          <td>10*9/L</td>
          <td>150-400</td>
          <td>Normal</td>
          <td>March 1, 2020</td>
        </tr>
      </tbody>
    </table>
  </text>

  <!-- Result Organizer Entry -->
  <entry typeCode="DRIV">
    <organizer classCode="CLUSTER" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.22.4.1" extension="2023-05-01"/>
      <id root="7d5a02b0-67a4-11db-bd13-0800200c9a66"/>
      <code code="58410-2"
            codeSystem="2.16.840.1.113883.6.1"
            displayName="CBC panel - Blood by Automated count"/>
      <statusCode code="completed"/>
      <effectiveTime value="20200301083000-0500"/>

      <!-- Author -->
      <author>
        <templateId root="2.16.840.1.113883.10.20.22.4.119"/>
        <time value="20200301153000-0500"/>
        <assignedAuthor>
          <id root="2.16.840.1.113883.4.6" extension="1234567890"/>
          <addr>
            <streetAddressLine>123 Lab Street</streetAddressLine>
            <city>Boston</city>
            <state>MA</state>
            <postalCode>02134</postalCode>
          </addr>
          <telecom use="WP" value="tel:+1-617-555-1234"/>
          <assignedPerson>
            <name>
              <given>Sarah</given>
              <family>Pathologist</family>
            </name>
          </assignedPerson>
          <representedOrganization>
            <name>Community Hospital Laboratory</name>
          </representedOrganization>
        </assignedAuthor>
      </author>

      <!-- Specimen -->
      <specimen typeCode="SPC">
        <specimenRole classCode="SPEC">
          <id root="c2ee9ee9-ae31-4628-a919-fec1cbb58683"/>
          <specimenPlayingEntity>
            <code code="122555007"
                  codeSystem="2.16.840.1.113883.6.96"
                  displayName="Venous blood specimen"/>
          </specimenPlayingEntity>
        </specimenRole>
      </specimen>

      <!-- Result Observations -->
      <component>
        <observation classCode="OBS" moodCode="EVN">
          <templateId root="2.16.840.1.113883.10.20.22.4.2" extension="2015-08-01"/>
          <id root="107c2dc0-67a5-11db-bd13-0800200c9a66"/>
          <code code="718-7"
                codeSystem="2.16.840.1.113883.6.1"
                displayName="Hemoglobin [Mass/volume] in Blood"/>
          <text>
            <reference value="#result1"/>
          </text>
          <statusCode code="completed"/>
          <effectiveTime value="20200301083000-0500"/>
          <value xsi:type="PQ" value="13.2" unit="g/dL"/>
          <interpretationCode code="N"
                             codeSystem="2.16.840.1.113883.5.83"
                             displayName="Normal"/>
          <referenceRange>
            <observationRange>
              <value xsi:type="IVL_PQ">
                <low value="12.0" unit="g/dL"/>
                <high value="16.0" unit="g/dL"/>
              </value>
              <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/>
            </observationRange>
          </referenceRange>
        </observation>
      </component>

      <component>
        <observation classCode="OBS" moodCode="EVN">
          <templateId root="2.16.840.1.113883.10.20.22.4.2" extension="2015-08-01"/>
          <id root="8b3fa370-67a5-11db-bd13-0800200c9a66"/>
          <code code="26464-8"
                codeSystem="2.16.840.1.113883.6.1"
                displayName="Leukocytes [#/volume] in Blood"/>
          <text>
            <reference value="#result2"/>
          </text>
          <statusCode code="completed"/>
          <effectiveTime value="20200301083000-0500"/>
          <value xsi:type="PQ" value="6.7" unit="10*9/L"/>
          <interpretationCode code="N"
                             codeSystem="2.16.840.1.113883.5.83"
                             displayName="Normal"/>
          <referenceRange>
            <observationRange>
              <value xsi:type="IVL_PQ">
                <low value="4.3" unit="10*9/L"/>
                <high value="10.8" unit="10*9/L"/>
              </value>
              <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/>
            </observationRange>
          </referenceRange>
        </observation>
      </component>

      <component>
        <observation classCode="OBS" moodCode="EVN">
          <templateId root="2.16.840.1.113883.10.20.22.4.2" extension="2015-08-01"/>
          <id root="a40027e1-67a5-11db-bd13-0800200c9a66"/>
          <code code="777-3"
                codeSystem="2.16.840.1.113883.6.1"
                displayName="Platelets [#/volume] in Blood"/>
          <text>
            <reference value="#result3"/>
          </text>
          <statusCode code="completed"/>
          <effectiveTime value="20200301083000-0500"/>
          <value xsi:type="PQ" value="250" unit="10*9/L"/>
          <interpretationCode code="N"
                             codeSystem="2.16.840.1.113883.5.83"
                             displayName="Normal"/>
          <referenceRange>
            <observationRange>
              <value xsi:type="IVL_PQ">
                <low value="150" unit="10*9/L"/>
                <high value="400" unit="10*9/L"/>
              </value>
              <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/>
            </observationRange>
          </referenceRange>
        </observation>
      </component>
    </organizer>
  </entry>
</section>
```

### Results Section with No Information

```xml
<section nullFlavor="NI">
  <templateId root="2.16.840.1.113883.10.20.22.2.3.1" extension="2015-08-01"/>
  <code code="30954-2"
        codeSystem="2.16.840.1.113883.6.1"
        displayName="Relevant diagnostic tests/laboratory data Narrative"/>
  <title>RESULTS</title>
  <text>No laboratory results available</text>
</section>
```

## Element Details

### Section Root

| Element | Cardinality | Type | Description |
|---------|------------|------|-------------|
| section | 1..1 | Section | Root element |
| classCode | 1..1 | code | Fixed: DOCSECT |
| moodCode | 1..1 | code | Fixed: EVN |

### templateId

| Element | Cardinality | Description |
|---------|------------|-------------|
| root | 1..1 | SHALL be `2.16.840.1.113883.10.20.22.2.3.1` (entries required) OR `2.16.840.1.113883.10.20.22.2.3` (entries optional) |
| extension | 0..1 | SHOULD be `2015-08-01` |

### code

The section code identifies the type of content.

| Attribute | Cardinality | Value |
|-----------|------------|-------|
| code | 1..1 | `30954-2` |
| codeSystem | 1..1 | `2.16.840.1.113883.6.1` (LOINC) |
| displayName | 0..1 | "Relevant diagnostic tests/laboratory data Narrative" |

### title

| Element | Cardinality | Description |
|---------|------------|-------------|
| title | 1..1 | Human-readable section label (typically "RESULTS" or "Laboratory Results") |

### text

| Element | Cardinality | Description |
|---------|------------|-------------|
| text | 1..1 | Narrative content required. Typically includes tables with test results. |

**Narrative Guidelines:**
- Use tables to present structured result data
- Include column headers for Test, Result, Units, Reference Range, Interpretation, Date
- Use ID attributes on table cells to allow structured data to reference narrative
- Group related tests together (e.g., by panel)
- Display dates in human-readable format

### entry (Result Organizer)

| Element | Cardinality | Description |
|---------|------------|-------------|
| entry | 0..* | Contains Result Organizer entries |
| typeCode | 1..1 | SHALL be "DRIV" (is derived from) |

**Conformance Rule:** If section/@nullFlavor is not present, SHALL contain at least one Result Organizer entry.

## Conditional Conformance Requirements

### Results Section (Entries Required)

1. **SHALL** contain exactly one `templateId` with root `2.16.840.1.113883.10.20.22.2.3.1`
2. **SHALL** contain exactly one `code` with code=`30954-2`
3. **SHALL** contain exactly one `title`
4. **SHALL** contain exactly one `text`
5. **CONDITIONAL:** If section/@nullFlavor is not present, SHALL contain at least one `entry` containing a Result Organizer

### Results Section (Entries Optional)

1. **SHALL** contain exactly one `templateId` with root `2.16.840.1.113883.10.20.22.2.3`
2. **SHALL** contain exactly one `code` with code=`30954-2`
3. **SHALL** contain exactly one `title`
4. **SHALL** contain exactly one `text`
5. **MAY** contain `entry` elements containing Result Organizers

## Subsectioning by Category

Results can be organized into subsections by diagnostic service category:

```xml
<section>
  <templateId root="2.16.840.1.113883.10.20.22.2.3.1" extension="2015-08-01"/>
  <code code="30954-2" codeSystem="2.16.840.1.113883.6.1"/>
  <title>RESULTS</title>
  <text>See subsections for organized results</text>

  <!-- Laboratory Subsection -->
  <component>
    <section>
      <code code="26436-6"
            codeSystem="2.16.840.1.113883.6.1"
            displayName="Laboratory studies"/>
      <title>Laboratory Results</title>
      <text>...</text>
      <entry><!-- Lab result organizers --></entry>
    </section>
  </component>

  <!-- Radiology Subsection -->
  <component>
    <section>
      <code code="18748-4"
            codeSystem="2.16.840.1.113883.6.1"
            displayName="Diagnostic imaging study"/>
      <title>Imaging Results</title>
      <text>...</text>
      <entry><!-- Imaging result organizers --></entry>
    </section>
  </component>
</section>
```

**Common Subsection Codes (LOINC):**
| Code | Display |
|------|---------|
| 26436-6 | Laboratory studies |
| 18748-4 | Diagnostic imaging study |
| 11502-2 | Laboratory report |
| 11526-1 | Pathology study |

## Terminology Bindings

| Element | Value Set | Binding Strength | OID |
|---------|-----------|------------------|-----|
| nullFlavor | CDANullFlavor | Required | - |
| classCode | ActClassRecordOrganizer (DOCSECT) | Required | - |
| moodCode | CDAActMood (EVN) | Required | - |
| languageCode | All Languages | Required | - |
| entry.typeCode | x_ActRelationshipEntry | Required | - |

## Document Usage

The Results Section is used in these C-CDA document types:
- Consultation Note (2.16.840.1.113883.10.20.22.1.4)
- Continuity of Care Document (CCD) (2.16.840.1.113883.10.20.22.1.2)
- Discharge Summary (2.16.840.1.113883.10.20.22.1.8)
- History and Physical (2.16.840.1.113883.10.20.22.1.3)
- Progress Note (2.16.840.1.113883.10.20.22.1.9)
- Referral Note (2.16.840.1.113883.10.20.22.1.14)
- Transfer Summary (2.16.840.1.113883.10.20.22.1.13)

## USCDI Data Elements

The Results Section supports these USCDI v4 data elements:
- **Laboratory:** Tests, Values/Results
- **Clinical Tests:** Results
- **Diagnostic Imaging:** Reports

## Key Constraints

| Constraint ID | Severity | Description |
|---------------|----------|-------------|
| shall-result-org | Error | If section/@nullFlavor is not present, SHALL contain at least one Result Organizer |
| 81-7296 | Error | Section code SHALL be `30954-2` |
| 81-9198 | Error | Title SHALL exist |
| 81-9199 | Error | Text SHALL exist |

## Usage Context

### When to Use Results Section

Use the Results Section when documenting:
- Laboratory test results (chemistry, hematology, microbiology, etc.)
- Imaging study results (x-ray, CT, MRI, ultrasound findings)
- Pathology findings
- Specialized diagnostic tests (cardiology, pulmonary function tests)
- Point-of-care testing results

### When Not to Use

Do NOT use Results Section for:
- Vital signs (use Vital Signs Section instead)
- Assessments and functional status (use appropriate assessment sections)
- Historical information about past results (use History of Past Illness)

## Implementation Notes

### Result Organization
- Group related tests using Result Organizers (e.g., CBC panel, metabolic panel)
- Individual test results are represented as Result Observations within the organizer
- Use LOINC codes for both panels (organizer/code) and individual tests (observation/code)

### Narrative Text Requirements
- The text element must include human-readable representation of all structured data
- Use ID attributes to link structured entries to narrative content
- Tables are the preferred format for presenting result data

### Specimen Information
- Specimen details can be attached at the Result Organizer level
- When a specimen applies to all observations in an organizer, attach it once at the organizer level
- Centralizing specimen details improves clarity and reduces redundancy

### Reference Ranges
- Include reference ranges when available to provide context for result interpretation
- Reference ranges should indicate normal/expected values

## References

- C-CDA R2.1 Implementation Guide
- C-CDA R5.0 (STU5 Ballot): https://build.fhir.org/ig/HL7/CDA-ccda/StructureDefinition-ResultsSection.html
- HL7 C-CDA Templates: http://www.hl7.org/ccdasearch/
- LOINC: https://loinc.org/
- USCDI v4: https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi
