STU 3 Candidate

This page is part of the FHIR Specification (v1.4.0: STU 3 Ballot 3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R4 R3 R2

V3-ObservationInterpretation.xml

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One or more codes specifying a rough qualitative interpretation of the observation, such as "normal", "abnormal", "below normal", "change up", "resistant", "susceptible", etc. OpenIssue: Description copied from Concept Domain of same name. Must be verified. Note also that this might be identical to the V2 code system of interpretation codes (formerly Abnormal Flags in older versions).

<ValueSet xmlns="http://hl7.org/fhir">
  <id value="v3-ObservationInterpretation"/>
  <meta>
    <lastUpdated value="2016-03-23T00:00:00.000+11:00"/>
    <profile value="http://hl7.org/fhir/StructureDefinition/valueset-shareable-definition"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p>Release Date: 2016-03-23</p>

      <table class="grid">
 
        <tr>
          <td>
            <b>Level</b>
          </td>
          <td>
            <b>Code</b>
          </td>
          <td>
            <b>Display</b>
          </td>
          <td>
            <b>Definition</b>
          </td>
        </tr>
 
        <tr>
          <td>1</td>
          <td>
            <span style="color: grey">
              <i>(_GeneticObservationInterpretation)</i>
            </span> 
            <b>
              <i>Abstract</i>
            </b>
          </td>
          <td>
            <a name="_GeneticObservationInterpretation"> </a>
          </td>
          <td>
                        Codes that specify interpretation of genetic analysis, such as
               &quot;positive&quot;, &quot;negative&quot;, &quot;carrier&quot;, &quot;responsive&quot;,
               etc.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  CAR
            <a name="CAR"> </a>
          </td>
          <td>Carrier</td>
          <td>
                        The patient is considered as carrier based on the testing results.
               A carrier is an individual who carries an altered form of a gene which can lead to having
               a child or offspring in future generations with a genetic disorder.
            <br/>

                     
          </td>
        </tr>
 
        <tr style="background: #EFEFEF">
          <td>2</td>
          <td>  Carrier
            <a name="Carrier"> </a> 
            <b>
              <i>Deprecated</i>
            </b>
          </td>
          <td>Carrier</td>
          <td>
                        The patient is considered as carrier based on the testing results.
               A carrier is an individual who carries an altered form of a gene which can lead to having
               a child or offspring in future generations with a genetic disorder.
            <br/>

                        
                           
                              Deprecation Comment: 
                           This code is currently the same string as the print name for
               this concept and is inconsistent with the conventions being used for the other codes in
               the coding system, as it is a full word with initial capitalization, rather than an all
               upper case mnemonic.  The recommendation from OO is to deprecate the code &quot;Carrier&quot;
               and to add &quot;CAR&quot; as the new active code representation for this concept.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>1</td>
          <td>
            <span style="color: grey">
              <i>(_ObservationInterpretationChange)</i>
            </span> 
            <b>
              <i>Abstract</i>
            </b>
          </td>
          <td>
            <a name="_ObservationInterpretationChange"> </a>
          </td>
          <td>
                        Interpretations of change of quantity and/or severity. At most
               one of B or W and one of U or D allowed.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  B
            <a name="B"> </a>
          </td>
          <td>Better</td>
          <td>
                        The current result or observation value has improved compared
               to the previous result or observation value (the change is significant as defined in the
               respective test procedure).
            <br/>

                        [Note: This can be applied to quantitative or qualitative observations.]
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  D
            <a name="D"> </a>
          </td>
          <td>Significant change down</td>
          <td>
                        The current result has decreased from the previous result for
               a quantitative observation (the change is significant as defined in the respective test
               procedure).
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  U
            <a name="U"> </a>
          </td>
          <td>Significant change up</td>
          <td>
                        The current result has increased from the previous result for
               a quantitative observation (the change is significant as defined in the respective test
               procedure).
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  W
            <a name="W"> </a>
          </td>
          <td>Worse</td>
          <td>
                        The current result or observation value has degraded compared
               to the previous result or observation value (the change is significant as defined in the
               respective test procedure).
            <br/>

                        [Note: This can be applied to quantitative or qualitative observations.]
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>1</td>
          <td>
            <span style="color: grey">
              <i>(_ObservationInterpretationExceptions)</i>
            </span> 
            <b>
              <i>Abstract</i>
            </b>
          </td>
          <td>
            <a name="_ObservationInterpretationExceptions"> </a>
          </td>
          <td>
                        Technical exceptions resulting in the inability to provide an
               interpretation. At most one allowed. Does not imply normality or severity.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  &lt;
            <a name=".60"> </a>
          </td>
          <td>Off scale low</td>
          <td>
                        The result is below the minimum detection limit (the test procedure
               or equipment is the limiting factor).
            <br/>

                        Synonyms: Below analytical limit, low off scale.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  &gt;
            <a name=".62"> </a>
          </td>
          <td>Off scale high</td>
          <td>
                        The result is above the maximum quantifiable limit (the test procedure
               or equipment is the limiting factor).
            <br/>

                        Synonyms: Above analytical limit, high off scale.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  AC
            <a name="AC"> </a>
          </td>
          <td>Anti-complementary substances present</td>
          <td>
                        A valid result cannot be obtained for the specified component
               / analyte due to the presence of anti-complementary substances in the sample.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  IE
            <a name="IE"> </a>
          </td>
          <td>Insufficient evidence</td>
          <td>
                        There is insufficient evidence that the species in question is
               a good target for therapy with the drug.  A categorical interpretation is not possible.
            <br/>

                        [Note: A MIC with &quot;IE&quot; and/or a comment may be reported
               (without an accompanying S, I or R-categorization).]
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  QCF
            <a name="QCF"> </a>
          </td>
          <td>Quality control failure</td>
          <td>
                        A result cannot be considered valid for the specified component
               / analyte or organism due to failure in the quality control testing component.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  TOX
            <a name="TOX"> </a>
          </td>
          <td>Cytotoxic substance present</td>
          <td>
                        A valid result cannot be obtained for the specified organism or
               cell line due to the presence of cytotoxic substances in the sample or culture.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>1</td>
          <td>
            <span style="color: grey">
              <i>(_ObservationInterpretationNormality)</i>
            </span> 
            <b>
              <i>Abstract</i>
            </b>
          </td>
          <td>
            <a name="_ObservationInterpretationNormality"> </a>
          </td>
          <td>
                        Interpretation of normality or degree of abnormality (including
               critical or &quot;alert&quot; level). Concepts in this category are mutually exclusive,
               i.e., at most one is allowed.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  A
            <a name="A"> </a>
          </td>
          <td>Abnormal</td>
          <td>
                        The result or observation value is outside the reference range
               or expected norm (as defined for the respective test procedure).
            <br/>

                        [Note: Typically applies to non-numeric results.]
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>3</td>
          <td>    AA
            <a name="AA"> </a>
          </td>
          <td>Critical abnormal</td>
          <td>
                        The result or observation value is outside a reference range or
               expected norm at a level at which immediate action should be considered for patient safety
               (as defined for the respective test procedure).
            <br/>

                        [Note: Typically applies to non-numeric results.  Analogous to
               critical/panic limits for numeric results.]
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>4</td>
          <td>      HH
            <a name="HH"> </a>
          </td>
          <td>Critical high</td>
          <td>
                        The result for a quantitative observation is above a reference
               level at which immediate action should be considered for patient safety (as defined for
               the respective test procedure).
            <br/>

                        Synonym: Above upper panic limits.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>4</td>
          <td>      LL
            <a name="LL"> </a>
          </td>
          <td>Critical low</td>
          <td>
                        The result for a quantitative observation is below a reference
               level at which immediate action should be considered for patient safety (as defined for
               the respective test procedure).
            <br/>

                        Synonym: Below lower panic limits.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>3</td>
          <td>    H
            <a name="H"> </a>
          </td>
          <td>High</td>
          <td>
                        The result for a quantitative observation is above the upper limit
               of the reference range (as defined for the respective test procedure).
            <br/>

                        Synonym: Above high normal
            <br/>

                     
          </td>
        </tr>
 
        <tr style="background: #EFEFEF">
          <td>4</td>
          <td>      H&gt;
            <a name="H.62"> </a> 
            <b>
              <i>Deprecated</i>
            </b>
          </td>
          <td>Significantly high</td>
          <td>A test result that is significantly higher than the reference (normal) or therapeutic
               interval, but has not reached the critically high value and might need special attention,
               as defined by the laboratory or the clinician.[Note: This level is situated between 'H'
               and 'HH'.]
            <br/>

                        
                           Deprecation Comment: The code 'H&gt;' is being deprecated in
               order to align with the use of the code 'HU' for &quot;Very high&quot; in V2 Table 0078
               &quot;Interpretation Codes&quot;.
            <br/>

                        [Note: The use of code 'H&gt;' is non-preferred, as this code
               is deprecated and on track to be retired; use code 'HU' instead.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>5</td>
          <td>        
            <a href="#HH">HH</a>
          </td>
          <td/>
          <td/>
        </tr>
 
        <tr>
          <td>4</td>
          <td>      HU
            <a name="HU"> </a>
          </td>
          <td>Significantly high</td>
          <td>
                        A test result that is significantly higher than the reference
               (normal) or therapeutic interval, but has not reached the critically high value and might
               need special attention, as defined by the laboratory or the clinician.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>5</td>
          <td>        
            <a href="#HH">HH</a>
          </td>
          <td/>
          <td/>
        </tr>
 
        <tr>
          <td>3</td>
          <td>    L
            <a name="L"> </a>
          </td>
          <td>Low</td>
          <td>
                        The result for a quantitative observation is below the lower limit
               of the reference range (as defined for the respective test procedure).
            <br/>

                        Synonym: Below low normal
            <br/>

                     
          </td>
        </tr>
 
        <tr style="background: #EFEFEF">
          <td>4</td>
          <td>      L&lt;
            <a name="L.60"> </a> 
            <b>
              <i>Deprecated</i>
            </b>
          </td>
          <td>Significantly low</td>
          <td>A test result that is significantly lower than the reference (normal) or therapeutic interval,
               but has not reached the critically low value and might need special attention, as defined
               by the laboratory or the clinician.[Note: This level is situated between 'L' and 'LL'.]
            <br/>

                        
                           Deprecation Comment: The code 'L&lt;' is being deprecated in
               order to align with the use of the code 'LU' for &quot;Very low&quot; in V2 Table 0078
               &quot;Interpretation Codes&quot;.
            <br/>

                        [Note: The use of code 'L&lt;' is non-preferred, as this code
               is deprecated and on track to be retired; use code 'LU' instead.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>5</td>
          <td>        
            <a href="#LL">LL</a>
          </td>
          <td/>
          <td/>
        </tr>
 
        <tr>
          <td>4</td>
          <td>      LU
            <a name="LU"> </a>
          </td>
          <td>Significantly low</td>
          <td>
                        A test result that is significantly lower than the reference (normal)
               or therapeutic interval, but has not reached the critically low value and might need special
               attention, as defined by the laboratory or the clinician.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>5</td>
          <td>        
            <a href="#LL">LL</a>
          </td>
          <td/>
          <td/>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  N
            <a name="N"> </a>
          </td>
          <td>Normal</td>
          <td>
                        The result or observation value is within the reference range
               or expected norm (as defined for the respective test procedure).
            <br/>

                        [Note: Applies to numeric or non-numeric results.]
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>1</td>
          <td>
            <span style="color: grey">
              <i>(_ObservationInterpretationSusceptibility)</i>
            </span> 
            <b>
              <i>Abstract</i>
            </b>
          </td>
          <td>
            <a name="_ObservationInterpretationSusceptibility"> </a>
          </td>
          <td>
                        Interpretations of anti-microbial susceptibility testing results
               (microbiology). At most one allowed.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  
            <a href="#IE">IE</a>
          </td>
          <td/>
          <td/>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  I
            <a name="I"> </a>
          </td>
          <td>Intermediate</td>
          <td>
                        Bacterial strain inhibited in vitro by a concentration of an antimicrobial
               agent that is associated with uncertain therapeutic effect. Reference: CLSI (http://www.clsi.org/Con
              tent/NavigationMenu/Resources/HarmonizedTerminologyDatabase/Harmonized_Terminolo.htm)
Projects: ISO 20776-1, ISO 20776-2
            <br/>

                        [Note 1: Bacterial strains are categorized as intermediate by
               applying the appropriate breakpoints in a defined phenotypic test system.]
            <br/>

                        [Note 2: This class of susceptibility implies that an infection
               due to the isolate can be appropriately treated in body sites where the drugs are physiologically
               concentrated or when a high dosage of drug can be used.]
            <br/>

                        [Note 3: This class also indicates a &quot;buffer zone,&quot;
               to prevent small, uncontrolled, technical factors from causing major discrepancies in
               interpretations.]
            <br/>

                        [Note 4: These breakpoints can be altered due to changes in circumstances
               (e.g., changes in commonly used drug dosages, emergence of new resistance mechanisms).]
            <br/>

                     
          </td>
        </tr>
 
        <tr style="background: #EFEFEF">
          <td>2</td>
          <td>  MS
            <a name="MS"> </a> 
            <b>
              <i>Deprecated</i>
            </b>
          </td>
          <td>moderately susceptible</td>
          <td>
                        The patient is considered as carrier based on the testing results.
               A carrier is an individual who carries an altered form of a gene which can lead to having
               a child or offspring in future generations with a genetic disorder.
            <br/>

                        
                           
                              Deprecation Comment: 
                           This antimicrobial susceptibility test interpretation concept
               is recommended by OO to be deprecated as it is no longer recommended for use in susceptibility
               testing by CLSI (reference CLSI document M100-S22; Vol. 32 No.3; CLSI Performance Standards
               for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement. Jan
               2012).  
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  NS
            <a name="NS"> </a>
          </td>
          <td>Non-susceptible</td>
          <td>
                        A category used for isolates for which only a susceptible interpretive
               criterion has been designated because of the absence or rare occurrence of resistant strains.
               Isolates that have MICs above or zone diameters below the value indicated for the susceptible
               breakpoint should be reported as non-susceptible.
            <br/>

                        NOTE 1: An isolate that is interpreted as non-susceptible does
               not necessarily mean that the isolate has a resistance mechanism. It is possible that
               isolates with MICs above the susceptible breakpoint that lack resistance mechanisms may
               be encountered within the wild-type distribution subsequent to the time the susceptible-only
               breakpoint is set. 
            <br/>

                        NOTE 2: For strains yielding results in the &quot;nonsusceptible&quot;
               category, organism identification and antimicrobial susceptibility test results should
               be confirmed.
            <br/>

                        Synonym: decreased susceptibility.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  R
            <a name="R"> </a>
          </td>
          <td>Resistant</td>
          <td>
                        Bacterial strain inhibited in vitro by a concentration of an antimicrobial
               agent that is associated with a high likelihood of therapeutic failure.
Reference: CLSI (http://www.clsi.org/Content/NavigationMenu/Resources/HarmonizedTerminologyDatabase/
              Harmonized_Terminolo.htm)  
Projects: ISO 20776-1, ISO 20776-2
            <br/>

                        [Note 1: Bacterial strains are categorized as resistant by applying
               the appropriate breakpoints in a defined phenotypic test system.]
            <br/>

                        [Note 2: This breakpoint can be altered due to changes in circumstances
               (e.g., changes in commonly used drug dosages, emergence of new resistance mechanisms).]
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>3</td>
          <td>    SYN-R
            <a name="SYN-R"> </a>
          </td>
          <td>Synergy - resistant</td>
          <td>
                        A category for isolates where the bacteria (e.g. enterococci)
               are not susceptible in vitro to a combination therapy (e.g., high-level aminoglycoside
               and cell wall active agent).  This is predictive that this combination therapy will not
               be effective. 
            <br/>

                        
                           Usage Note: Since the use of penicillin or ampicillin alone
               often results in treatment failure of serious enterococcal or other bacterial infections,
               combination therapy is usually indicated to enhance bactericidal activity. The synergy
               between a cell wall active agent (such as penicillin, ampicillin, or vancomycin) and an
               aminoglycoside (such as gentamicin, kanamycin or streptomycin) is best predicted by screening
               for high-level bacterial resistance to the aminoglycoside.
            <br/>

                        
                           Open Issue: The print name of the code is very general and
               the description is very specific to a pair of classes of agents, which may lead to confusion
               of these concepts in the future should other synergies be found.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  S
            <a name="S"> </a>
          </td>
          <td>Susceptible</td>
          <td>
                        Bacterial strain inhibited by in vitro concentration of an antimicrobial
               agent that is associated with a high likelihood of therapeutic success.
Reference: CLSI (http://www.clsi.org/Content/NavigationMenu/Resources/HarmonizedTerminologyDatabase/
              Harmonized_Terminolo.htm)
Synonym (earlier term): Sensitive Projects: ISO 20776-1, ISO 20776-2
            <br/>

                        [Note 1: Bacterial strains are categorized as susceptible by applying
               the appropriate breakpoints in a defined phenotypic system.]
            <br/>

                        [Note 2: This breakpoint can be altered due to changes in circumstances
               (e.g., changes in commonly used drug dosages, emergence of new resistance mechanisms).]
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>3</td>
          <td>    SDD
            <a name="SDD"> </a>
          </td>
          <td>Susceptible-dose dependent</td>
          <td>
                        A category that includes isolates with antimicrobial agent minimum
               inhibitory concentrations (MICs) that approach usually attainable blood and tissue levels
               and for which response rates may be lower than for susceptible isolates.
            <br/>

                        Reference: CLSI document M44-A2 2009 &quot;Method for antifungal
               disk diffusion susceptibility testing of yeasts; approved guideline - second edition&quot;
               - page 2.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>3</td>
          <td>    SYN-S
            <a name="SYN-S"> </a>
          </td>
          <td>Synergy - susceptible</td>
          <td>
                        A category for isolates where the bacteria (e.g. enterococci)
               are susceptible in vitro to a combination therapy (e.g., high-level aminoglycoside and
               cell wall active agent).  This is predictive that this combination therapy will be effective.
               
            <br/>

                        
                           Usage Note: Since the use of penicillin or ampicillin alone
               often results in treatment failure of serious enterococcal or other bacterial infections,
               combination therapy is usually indicated to enhance bactericidal activity. The synergy
               between a cell wall active agent (such as penicillin, ampicillin, or vancomycin) and an
               aminoglycoside (such as gentamicin, kanamycin or streptomycin) is best predicted by screening
               for high-level bacterial resistance to the aminoglycoside.
            <br/>

                        
                           Open Issue: The print name of the code is very general and
               the description is very specific to a pair of classes of agents, which may lead to confusion
               of these concepts in the future should other synergies be found.
            <br/>

                     
          </td>
        </tr>
 
        <tr style="background: #EFEFEF">
          <td>2</td>
          <td>  VS
            <a name="VS"> </a> 
            <b>
              <i>Deprecated</i>
            </b>
          </td>
          <td>very susceptible</td>
          <td>
                        The patient is considered as carrier based on the testing results.
               A carrier is an individual who carries an altered form of a gene which can lead to having
               a child or offspring in future generations with a genetic disorder.
            <br/>

                        
                           
                              Deprecation Comment: 
                           This antimicrobial susceptibility test interpretation concept
               is recommended by OO to be deprecated as it is no longer recommended for use in susceptibility
               testing by CLSI (reference CLSI document M100-S22; Vol. 32 No.3; CLSI Performance Standards
               for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement. Jan
               2012).  
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>1</td>
          <td>EX
            <a name="EX"> </a>
          </td>
          <td>outside threshold</td>
          <td>
                        The observation/test result is interpreted as being outside the
               inclusion range for a particular protocol within which the result is being reported.

            <br/>

                        Example: A positive result on a Hepatitis screening test.
                           Open Issue: EX, HX, LX: These three concepts do not seem to
               meet a clear need in the vocabulary, and their use in observation interpretation appears
               likely to be covered by other existing concepts (e.g., A, H, L).  The only apparent significant
               difference is their reference to use in protocols for exclusion of study subjects.
These concepts/codes were proposed by RCRIM for use in the CTLaboratory message.  They
               were submitted and approved in the November 2005 Harmonization cycle in proposal &quot;030103C_VOCAB
              _RCRIM_l_quade_RCRIM Obs Interp_20051028154455&quot;.  However, this proposal was not fully
               implemented in the vocabulary.  The proposal recommended creation of the x_ClinicalResearchExclusion
               domain in ObservationInterpretation with a value set including those three concepts/codes,
               but there is no subdomain of that name or equivalent with a binding to either of the value
               sets that contain these concepts/codes.
Members of the OO WG have recently attempted to contact members of RCRIM regarding these
               concepts, both by email and at the recent WGM in Atlanta, without response.  It is felt
               by OO that the best course of action to take at this time is to add this comprehensive
               Open Issue rather than deprecate these three concepts at this time, until further discussion
               is held.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  HX
            <a name="HX"> </a>
          </td>
          <td>above high threshold</td>
          <td>
                        The observation/test result is interpreted as being outside the
               inclusion range for a particular protocol within which the result is being reported.

            <br/>

                        Example: A positive result on a Hepatitis screening test.
                           Open Issue: EX, HX, LX: These three concepts do not seem to
               meet a clear need in the vocabulary, and their use in observation interpretation appears
               likely to be covered by other existing concepts (e.g., A, H, L).  The only apparent significant
               difference is their reference to use in protocols for exclusion of study subjects.  These
               concepts/codes were proposed by RCRIM for use in the CTLaboratory message.  They were
               submitted and approved in the November 2005 Harmonization cycle in proposal &quot;030103C_VOCAB_RCRI
              M_l_quade_RCRIM Obs Interp_20051028154455&quot;. However, this proposal was not fully implemented
               in the vocabulary.  The proposal recommended creation of the x_ClinicalResearchExclusion
               domain in ObservationInterpretation with a value set including those three concepts/codes,
               but there is no subdomain of that name or equivalent with a binding to either of the value
               sets that contain these concepts/codes.  Members of the OO WG have recently attempted
               to contact members of RCRIM regarding these concepts, both by email and at the recent
               WGM in Atlanta, without response.  It is felt by OO that the best course of action to
               take at this time is to add this comprehensive Open Issue rather than deprecate these
               three concepts at this time, until further discussion is held.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  LX
            <a name="LX"> </a>
          </td>
          <td>below low threshold</td>
          <td>
                        The numeric observation/test result is interpreted as being below
               the low threshold value for a particular protocol within which the result is being reported.
            <br/>

                        Example: A Total White Blood Cell Count falling below a protocol-defined
               threshold value of 3000/mm^3
                           Open Issue: EX, HX, LX: These three concepts do not seem to
               meet a clear need in the vocabulary, and their use in observation interpretation appears
               likely to be covered by other existing concepts (e.g., A, H, L).  The only apparent significant
               difference is their reference to use in protocols for exclusion of study subjects.  These
               concepts/codes were proposed by RCRIM for use in the CTLaboratory message.  They were
               submitted and approved in the November 2005 Harmonization cycle in proposal &quot;030103C_VOCAB_RCRI
              M_l_quade_RCRIM Obs Interp_20051028154455&quot;.  However, this proposal was not fully
               implemented in the vocabulary.  The proposal recommended creation of the x_ClinicalResearchExclusion
               domain in ObservationInterpretation with a value set including those three concepts/codes,
               but there is no subdomain of that name or equivalent with a binding to either of the value
               sets that contain these concepts/codes.  Members of the OO WG have recently attempted
               to contact members of RCRIM regarding these concepts, both by email and at the recent
               WGM in Atlanta, without response.  It is felt by OO that the best course of action to
               take at this time is to add this comprehensive Open Issue rather than deprecate these
               three concepts at this time, until further discussion is held.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>1</td>
          <td>
            <span style="color: grey">
              <i>(ObservationInterpretationDetection)</i>
            </span> 
            <b>
              <i>Abstract</i>
            </b>
          </td>
          <td>
            <a name="ObservationInterpretationDetection"> </a>
          </td>
          <td>
                        Interpretations of the presence or absence of a component / analyte
               or organism in a test or of a sign in a clinical observation. In keeping with laboratory
               data processing practice, these concepts provide a categorical interpretation of the &quot;meaning&q
              uot; of the quantitative value for the same observation.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  IND
            <a name="IND"> </a>
          </td>
          <td>Indeterminate</td>
          <td>
                        The specified component / analyte, organism or clinical sign could
               neither be declared positive / negative nor detected / not detected by the performed test
               or procedure.
            <br/>

                        
                           Usage Note: For example, if the specimen was degraded, poorly
               processed, or was missing the required anatomic structures, then &quot;indeterminate&quot;
               (i.e. &quot;cannot be determined&quot;) is the appropriate response, not &quot;equivocal&quot;.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>3</td>
          <td>    E
            <a name="E"> </a>
          </td>
          <td>Equivocal</td>
          <td>
                        The test or procedure was successfully performed, but the results
               are borderline and can neither be declared positive / negative nor detected / not detected
               according to the current established criteria.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  NEG
            <a name="NEG"> </a>
          </td>
          <td>Negative</td>
          <td>
                        An absence finding of the specified component / analyte, organism
               or clinical sign based on the established threshold of the performed test or procedure.
            <br/>

                        [Note: Negative does not necessarily imply the complete absence
               of the specified item.] 
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>3</td>
          <td>    ND
            <a name="ND"> </a>
          </td>
          <td>Not detected</td>
          <td>
                        The presence of the specified component / analyte, organism or
               clinical sign could not be determined within the limit of detection of the performed test
               or procedure.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  POS
            <a name="POS"> </a>
          </td>
          <td>Positive</td>
          <td>
                        A presence finding of the specified component / analyte, organism
               or clinical sign based on the established threshold of the performed test or procedure.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>3</td>
          <td>    DET
            <a name="DET"> </a>
          </td>
          <td>Detected</td>
          <td>
                        The measurement of the specified component / analyte, organism
               or clinical sign above the limit of detection of the performed test or procedure.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>1</td>
          <td>
            <span style="color: grey">
              <i>(ObservationInterpretationExpectation)</i>
            </span> 
            <b>
              <i>Abstract</i>
            </b>
          </td>
          <td>
            <a name="ObservationInterpretationExpectation"> </a>
          </td>
          <td>
                        Interpretation of the observed result taking into account additional
               information (contraindicators) about the patient's situation. Concepts in this category
               are mutually exclusive, i.e., at most one is allowed. 
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  EXP
            <a name="EXP"> </a>
          </td>
          <td>Expected</td>
          <td>
                        This result has been evaluated in light of known contraindicators.
                Once those contraindicators have been taken into account the result is determined to
               be &quot;Expected&quot;  (e.g., presence of drugs in a patient that is taking prescription
               medication for pain management).
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  UNE
            <a name="UNE"> </a>
          </td>
          <td>Unexpected</td>
          <td>
                        This result has been evaluated in light of known contraindicators.
                Once those contraindicators have been taken into account the result is determined to
               be &quot;Unexpected&quot; (e.g., presence of non-prescribed drugs in a patient that is
               taking prescription medication for pain management).
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>1</td>
          <td>
            <span style="color: grey">
              <i>(ReactivityObservationInterpretation)</i>
            </span> 
            <b>
              <i>Abstract</i>
            </b>
          </td>
          <td>
            <a name="ReactivityObservationInterpretation"> </a>
          </td>
          <td>
                        Interpretations of the presence and level of reactivity of the
               specified component / analyte with the reagent in the performed laboratory test.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  NR
            <a name="NR"> </a>
          </td>
          <td>Non-reactive</td>
          <td>
                        An absence finding used to indicate that the specified component
               / analyte did not react measurably with the reagent.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>2</td>
          <td>  RR
            <a name="RR"> </a>
          </td>
          <td>Reactive</td>
          <td>
                        A presence finding used to indicate that the specified component
               / analyte reacted with the reagent above the reliably measurable limit of the performed
               test.
            <br/>

                     
          </td>
        </tr>
 
        <tr>
          <td>3</td>
          <td>    WR
            <a name="WR"> </a>
          </td>
          <td>Weakly reactive</td>
          <td>
                        A weighted presence finding used to indicate that the specified
               component / analyte reacted with the reagent, but below the reliably measurable limit
               of the performed test.
            <br/>

                     
          </td>
        </tr>

      </table>

    </div>
  </text>
  <extension url="http://hl7.org/fhir/StructureDefinition/valueset-oid">
    <valueUri value="urn:oid:2.16.840.1.113883.1.11.78"/>
  </extension>
  <url value="http://hl7.org/fhir/ValueSet/v3-ObservationInterpretation"/>
  <version value="2016-03-23"/>
  <name value="v3 Code System ObservationInterpretation"/>
  <status value="active"/>
  <experimental value="false"/>
  <publisher value="HL7, Inc"/>
  <contact>
    <telecom>
      <system value="other"/>
      <value value="http://hl7.org"/>
    </telecom>
  </contact>
  <date value="2016-03-23"/>
  <description value=" One or more codes specifying a rough qualitative interpretation of the observation, such
     as &quot;normal&quot;, &quot;abnormal&quot;, &quot;below normal&quot;, &quot;change up&quot;,
     &quot;resistant&quot;, &quot;susceptible&quot;, etc.  OpenIssue: Description copied from
     Concept Domain of same name.  Must be verified.  Note also that this might be identical
     to the V2 code system of interpretation codes (formerly Abnormal Flags in older versions)."/>
  <compose>
    <include>
      <system value="http://hl7.org/fhir/v3/ObservationInterpretation"/>
    </include>
  </compose>
</ValueSet>

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.