Release 4

V2-0078.vs.xml

Vocabulary Work GroupMaturity Level: N/AStandards Status: Informative

Raw XML (canonical form + also see XML Format Specification)

HL7-defined code system of concepts which specify a categorical assessment of an observation value. Notes: This is being communicated in v2.x in OBX-8 (Observation Interpretation), in v3 in ObservationInterpretation (CWE) in R1 (Representative Realm) and in FHIR in Observation.interpretation.

<?xml version="1.0" encoding="UTF-8"?>

<ValueSet xmlns="http://hl7.org/fhir">
  <id value="v2-0078"/> 
  <meta> 
    <profile value="http://hl7.org/fhir/StructureDefinition/shareablevalueset"/> 
  </meta> 
  <language value="en"/> 
  <text> 
    <status value="additional"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p> Interpretation Codes</p> 

      <table class="grid">
        <tr> 
          <td> 
            <b> Code</b> 
          </td> 
          <td> 
            <b> Description</b> 
          </td> 
          <td> 
            <b> Comment</b> 
          </td> 
          <td> 
            <b> Version</b> 
          </td> 
        </tr> 
        <tr> 
          <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).
Synonyms: Below analytical limit, low off scale</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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).
Synonyms: Above analytical limit, high off scale</td> 
          <td> added v2.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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).
Note: Typically applies to non-numeric results.</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> AA
            <a name="AA"> </a> 
          </td> 
          <td> Critically 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).
[Note: Typically applies to non-numeric results.  Analogous to critical/panic limits for
               numeric results.]</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> AC
            <a name="AC"> </a> 
          </td> 
          <td> Anti-complementary substances present</td> 
          <td> Deprecated</td> 
          <td> added v2.7, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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).
Note: This can be applied to quantitative or qualitative observations.</td> 
          <td> added v2.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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).</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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.</td> 
          <td> added v2.7, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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).
Synonym: Above high normal</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> HH
            <a name="HH"> </a> 
          </td> 
          <td> Critically 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).
Synonym: Above upper panic limits</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> HM
            <a name="HM"> </a> 
          </td> 
          <td> Hold for Medical Review</td> 
          <td> Deprecated</td> 
          <td> added v2.8, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> HU
            <a name="HU"> </a> 
          </td> 
          <td> Very high</td> 
          <td> Significantly high: 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’.</td> 
          <td> added v2.8.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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/Content/NavigationMenu/Resources/HarmonizedTerminologyDatabase/
              Harmonized_Terminolo.htm)
Projects: ISO 20776-1, ISO 20776-2

Note 1: Bacterial strains are categorized as intermediate by applying the appropriate
               breakpoints in a defined phenotypic test system.

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.

Note 3: This class also indicates a “buffer zone,” to prevent small, uncontrolled, technical
               factors from causing major discrepancies in interpretations.

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).</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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.
Reference: EUCAST

Note: A MIC with “IE” and/or a comment may be reported (without an accompanying S, I or
               R-categorization).</td> 
          <td> added v2.8.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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 or detected / not detected by the performed test or procedure.</td> 
          <td> added v2.7, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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).
Synonym: Below low normal</td> 
          <td> added v2.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> LL
            <a name="LL"> </a> 
          </td> 
          <td> Critically 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).
Synonym: Below lower panic limits</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> LU
            <a name="LU"> </a> 
          </td> 
          <td> Very low</td> 
          <td> Significantly low: 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’.</td> 
          <td> added v2.8.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> MS
            <a name="MS"> </a> 
          </td> 
          <td> Moderately susceptible. Indicates for microbiology susceptibilities only.</td> 
          <td> Deprecated - CLSI now only supports S, I &amp; R. This information can be found in CLSI
               document M100-S22;  Vol. 32 No.3;  CLSI Performance
Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement.
                Jan 2012.</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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).
Note: Applies to numeric or non-numeric results.</td> 
          <td> added v2.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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.</td> 
          <td> added v2.7, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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.
Note: Negative does not necessarily imply the complete absence of the specified item.</td> 
          <td> added v2.7, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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.</td> 
          <td> added v2.7, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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.

Synonym: decreased susceptibility

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.

Note 2: For strains yielding results in the “nonsusceptible” category, organism identification
               and antimicrobial susceptibility test results should be confirmed.</td> 
          <td> added v2.8.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> null
            <a name="null"> </a> 
          </td> 
          <td> No range defined, or normal ranges don't apply</td> 
          <td> Deprecated</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> OBX
            <a name="OBX"> </a> 
          </td> 
          <td> Interpretation qualifiers in separate OBX segments</td> 
          <td> Deprecated</td> 
          <td> added v2.8, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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.</td> 
          <td> added v2.7, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> QCF
            <a name="QCF"> </a> 
          </td> 
          <td> Quality Control Failure</td> 
          <td> Deprecated</td> 
          <td> added v2.7, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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

Note 1: Bacterial strains are categorized as resistant by applying the appropriate breakpoints
               in a defined phenotypic test system.

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).</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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.</td> 
          <td> added v2.7, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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) 
Projects: ISO 20776-1, ISO 20776-2

Synonym (earlier term): Sensitive

Note 1: Bacterial strains are categorized as susceptible by applying the appropriate breakpoints
               in a defined phenotypic system.

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).</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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.
Reference: CLSI document M44-A2 2009 “Method for antifungal disk diffusion susceptibility
               testing of yeasts; approved guideline – second edition” – page 2.</td> 
          <td> added v2.8.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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. 

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.

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.</td> 
          <td> added v2.8.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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. 

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.

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.</td> 
          <td> added v2.8.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> TOX
            <a name="TOX"> </a> 
          </td> 
          <td> Cytotoxic substance present</td> 
          <td> Deprecated</td> 
          <td> added v2.7, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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).</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <td> VS
            <a name="VS"> </a> 
          </td> 
          <td> Very susceptible. Indicates for microbiology susceptibilities only.</td> 
          <td> Deprecated - CLSI now only supports S, I &amp; R. This information can be found in CLSI
               document M100-S22;  Vol. 32 No.3;  CLSI Performance
Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement.
                Jan 2012.</td> 
          <td> from v2.1, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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).
Note: This can be applied to quantitative or qualitative observations.</td> 
          <td> added v2.2, removed after v2.8.2</td> 
        </tr> 
        <tr> 
          <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.</td> 
          <td> added v2.7, removed after v2.8.2</td> 
        </tr> 
      </table> 

    </div> 
  </text> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="external"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="0"/> 
  </extension> 
  <url value="http://terminology.hl7.org/ValueSet/v2-0078"/> 
  <version value="2.9"/> 
  <name value="v2.0078"/> 
  <title value="v2 ABNORMAL FLAGS"/> 
  <status value="active"/> 
  <experimental value="false"/> 
  <publisher value="HL7, Inc"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="http://hl7.org"/> 
    </telecom> 
  </contact> 
  <description value="HL7-defined code system of concepts which specify a categorical assessment of an observation
     value.   
   
   Notes:
   
   This is being communicated in v2.x in OBX-8 (Observation Interpretation), in v3 in
     ObservationInterpretation (CWE) in R1 (Representative Realm) and in FHIR in    Observation.interpret
    ation."/> 
  <immutable value="true"/> 
  <compose> 
    <include> 
      <system value="http://terminology.hl7.org/CodeSystem/v2-0078"/> 
    </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.