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#2).
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Vocabulary
Work
Group
|
Maturity Level : N/A | External | Use Context : Any |
This
value
set
(http://hl7.org/fhir/ValueSet/v3-ObservationInterpretation)
(http://terminology.hl7.org/ValueSet/v3-ObservationInterpretation)
is
defined
as
part
of
HL7
v3.
Related
FHIR
content:
Observation
Interpretation
Codes
.
Summary
| Defining URL: |
|
| Version: | 2018-08-12 |
| Name: | v3.ObservationInterpretation |
| Title: | v3 Code System ObservationInterpretation |
| Definition: |
One
or
more
codes
|
| OID: | 2.16.840.1.113883.1.11.78 (for OID based terminology systems) |
| Source Resource | XML / JSON |
This value set is used in the following places:
This value set includes codes from the following code systems:
Terminology
http://hl7.org/fhir/v3/ObservationInterpretation
http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation
This
expansion
generated
19
Apr
2017
Aug
2018
This
value
set
contains
48
39
concepts
Expansion
based
on
http://hl7.org/fhir/v3/ObservationInterpretation
http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation
version
2016-11-11
2018-08-12
All
codes
from
system
http://hl7.org/fhir/v3/ObservationInterpretation
http://terminology.hl7.org/CodeSystem/v3-ObservationInterpretation
| Lvl | Code | Display | Definition |
| 0 | _GeneticObservationInterpretation | GeneticObservationInterpretation |
Codes
that
specify
interpretation
of
genetic
analysis,
such
as
|
| 1 | CAR | Carrier | 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. |
|
|
_ObservationInterpretationChange | ObservationInterpretationChange | Interpretations of change of quantity and/or severity. At most one of B or W and one of U or D allowed. |
| 1 | B | Better | 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.] |
| 1 | D | Significant change down | The current result has decreased from the previous result for a quantitative observation (the change is significant as defined in the respective test procedure). |
| 1 | U | Significant change up | The current result has increased from the previous result for a quantitative observation (the change is significant as defined in the respective test procedure). |
| 1 | W | Worse | 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.] |
| 0 | _ObservationInterpretationExceptions | ObservationInterpretationExceptions | Technical exceptions resulting in the inability to provide an interpretation. At most one allowed. Does not imply normality or severity. |
| 1 | < | Off scale low | The result is below the minimum detection limit (the test procedure or equipment is the limiting factor). Synonyms: Below analytical limit, low off scale. |
| 1 | > | Off scale high | The result is above the maximum quantifiable limit (the test procedure or equipment is the limiting factor). Synonyms: Above analytical limit, high off scale. |
|
|
IE | Insufficient evidence |
There
is
insufficient
evidence
that
the
species
in
question
is
a
good
target
for
therapy
with
the
drug.
A
categorical
interpretation
is
not
possible.
[Note:
A
MIC
with
|
|
|
_ObservationInterpretationNormality | ObservationInterpretationNormality |
Interpretation
of
normality
or
degree
of
abnormality
(including
critical
or
|
| 1 | A | Abnormal | 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.] |
| 2 | AA | Critical abnormal | 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.] |
| 3 | HH | Critical high | 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. |
| 3 | LL | Critical low | 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. |
| 2 | H | High | 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 |
|
|
HU | 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. |
| 2 | L | Low | 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 |
|
|
LU | 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. |
| 1 | N | Normal | 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.] |
| 0 | _ObservationInterpretationSusceptibility | ObservationInterpretationSusceptibility | Interpretations of anti-microbial susceptibility testing results (microbiology). At most one allowed. |
| 1 | I | Intermediate |
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
|
| 1 |
|
|
|
| 1 | NS | Non-susceptible |
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.
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
|
| 1 | R | Resistant | 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).] |
| 2 | SYN-R | Synergy - resistant | 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. |
| 1 | S | Susceptible | 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 [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).] |
| 2 | SDD | Susceptible-dose dependent |
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
|
| 2 | SYN-S | Synergy - susceptible | 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. |
|
|
EX | outside threshold |
The
observation/test
result
is
interpreted
as
being
outside
the
inclusion
range
for
a
particular
protocol
within
which
the
result
is
being
reported.
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
|
| 1 | HX | above high threshold |
The
observation/test
result
is
interpreted
as
being
outside
the
inclusion
range
for
a
particular
protocol
within
which
the
result
is
being
reported.
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
|
| 1 | LX | below low threshold |
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.
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
|
|
|
ObservationInterpretationDetection | ObservationInterpretationDetection |
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
|
| 1 | IND | Indeterminate |
The
specified
component
/
analyte,
organism
or
clinical
sign
could
neither
be
declared
positive
/
negative
nor
detected
/
not
detected
by
the
performed
test
or
procedure.
Usage
Note:
For
example,
if
the
specimen
was
degraded,
poorly
processed,
or
was
missing
the
required
anatomic
structures,
then
|
| 2 | E | Equivocal | 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. |
| 1 | NEG | Negative | 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.] |
| 2 | ND | Not detected | 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. |
| 1 | POS | Positive | A presence finding of the specified component / analyte, organism or clinical sign based on the established threshold of the performed test or procedure. |
| 2 | DET | Detected | The measurement of the specified component / analyte, organism or clinical sign above the limit of detection of the performed test or procedure. |
| 0 | ObservationInterpretationExpectation | ObservationInterpretationExpectation | 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. |
| 1 | EXP | Expected |
This
result
has
been
evaluated
in
light
of
known
contraindicators.
Once
those
contraindicators
have
been
taken
into
account
the
result
is
determined
to
be
|
| 1 | UNE | Unexpected |
This
result
has
been
evaluated
in
light
of
known
contraindicators.
Once
those
contraindicators
have
been
taken
into
account
the
result
is
determined
to
be
|
|
|
ReactivityObservationInterpretation | ReactivityObservationInterpretation | Interpretations of the presence and level of reactivity of the specified component / analyte with the reagent in the performed laboratory test. |
| 1 | NR | Non-reactive | An absence finding used to indicate that the specified component / analyte did not react measurably with the reagent. |
| 1 | RR | Reactive | A presence finding used to indicate that the specified component / analyte reacted with the reagent above the reliably measurable limit of the performed test. |
| 2 | WR | Weakly reactive | 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. |
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HL7.org
2011+.
FHIR
Release
3
(STU;
v3.0.2-11200)
Mixed
Nomative/Trial
Use
Ballot
#2
(v3.5.0-14907)
generated
on
Thurs,
Oct
24,
2019
11:53+1100.
Sun,
Aug
19,
2018
21:55+1000.
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