ID

40048

Beschreibung

This is a complete version of the FHIR resource Observation v4.0.0. FHIR version R4 (v4.0.0). FHIR is a platform specification that defines a set of capabilities use across the healthcare process, in all jurisdictions, and in lots of different context. https://www.hl7.org/fhir/resourcelist.html Observations are a central element in healthcare, used to support diagnosis, monitor progress, determine baselines and patterns and even capture demographic characteristics. Most observations are simple name/value pair assertions with some metadata, but some observations group other observations together logically, or even are multi-component observations. The Observation resource is referenced by DiagnosticReport to represent laboratory, imaging, and other clinical and diagnostic data to form a complete report.

Link

https://www.hl7.org/fhir/resourcelist.html

Stichworte

Versionen (2)
  1. 10.03.20 10.03.20 -
  2. 10.03.20 10.03.20 -
Rechteinhaber

HL7 FHIR

Hochgeladen am

10. März 2020

DOI

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Lizenz

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FHIR v4.0.0

Englisch

Resource Observation

1 Formulare  
  1. StudyEvent: ODM
    1. Resource Observation
Observation
Beschreibung

Observation

Alias
UMLS CUI-1
C1554188
Observation identifier
Beschreibung

A unique identifier assigned to this observation. This is a business identifier, not a resource identifier.

Datentyp

text

Alias
UMLS CUI [1,1]
C1554188
UMLS CUI [1,2]
C0600091
Observation basis
Beschreibung

A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

Datentyp

text

Alias
UMLS CUI [1,1]
C1554188
UMLS CUI [1,2]
C1527178
If observation is part of a larger event, please fill in
Beschreibung

A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

Datentyp

text

Alias
UMLS CUI [1,1]
C1554188
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C1705248
Observation status
Beschreibung

The status of the result value. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-status.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1554188
UMLS CUI [1,2]
C0449438
Observation category
Beschreibung

A code that classifies the general type of observation being made. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-category.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1554188
UMLS CUI [1,2]
C0683312
Observation code
Beschreibung

Describes what was observed. Sometimes this is called the observation "name". The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-codes.html.

Datentyp

text

Alias
UMLS CUI [1,1]
C1554188
UMLS CUI [1,2]
C0805701
Observation subject
Beschreibung

The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

Datentyp

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1554188
Focus of observation
Beschreibung

The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

Datentyp

text

Alias
UMLS CUI [1,1]
C1554188
UMLS CUI [1,2]
C1521840
Encounter
Beschreibung

The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

Datentyp

text

Alias
UMLS CUI [1,1]
C1947978
UMLS CUI [1,2]
C1554188
Relevant time of an observed value
Beschreibung

The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0302523
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0040223
Date and time this observation was issued to providers
Beschreibung

The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1554188
UMLS CUI [1,2]
C4684787
Performer of observation
Beschreibung

Who was responsible for asserting the observed value as "true".

Datentyp

text

Alias
UMLS CUI [1,1]
C1554188
UMLS CUI [1,2]
C1552014
Value of observation
Beschreibung

The information determined as a result of making the observation, if the information has a simple value. An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

Datentyp

text

Alias
UMLS CUI [1,1]
C1554188
UMLS CUI [1,2]
C1301772
Reason for absent data during observation
Beschreibung

Provides a reason why the expected value in the element Observation.value[x] is missing.

Datentyp

text

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1554188
UMLS CUI [1,3]
C1511726
Codes that specify interpretation of genetic analysis
Beschreibung

Codes that specify interpretation of genetic analysis, such as "positive", "negative", "carrier", "responsive", etc. 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. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C2711437
UMLS CUI [1,2]
C1554188
UMLS CUI [1,3]
C0796344
Interpretation of change
Beschreibung

Interpretations of change of quantity and/or severity. At most one of B or W and one of U or D allowed. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C2711437
UMLS CUI [1,2]
C1554188
UMLS CUI [1,3]
C4319952
Exceptions of interpretation
Beschreibung

Technical exceptions resulting in the inability to provide an interpretation. At most one allowed. Does not imply normality or severity. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C2711437
UMLS CUI [1,3]
C1554188
Interpretation of normality
Beschreibung

Interpretation of normality or degree of abnormality (including critical or "alert" level). Concepts in this category are mutually exclusive, i.e., at most one is allowed. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C0949333
UMLS CUI [1,2]
C2711437
UMLS CUI [1,3]
C1554188
Interpretation of anti-microbial susceptibility testing results
Beschreibung

Interpretations of anti-microbial susceptibility testing results (microbiology). At most one allowed. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C0750491
UMLS CUI [1,2]
C2711437
UMLS CUI [1,3]
C1554188
Interpretations of the presence or absence of a component
Beschreibung

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 "meaning" of the quantitative value for the same observation. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C2711437
UMLS CUI [1,3]
C1554188
Interpretation of the observed result taking into account additional information
Beschreibung

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. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C0679138
UMLS CUI [1,2]
C2711437
UMLS CUI [1,3]
C1554188
Interpretation of the presence and level of reactivity of the specified component
Beschreibung

Interpretations of the presence and level of reactivity of the specified component / analyte with the reagent in the performed laboratory test. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C2711437
UMLS CUI [1,3]
C1554188
Comments about the observation or the results
Beschreibung

Comments about the observation or the results. May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1317574
UMLS CUI [1,2]
C1554188
UMLS CUI [2,1]
C1317574
UMLS CUI [2,2]
C1274040
Site on the subject's body where observation was made
Beschreibung

Indicates the site on the subject's body where the observation was made (i.e. the target site). Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-body-site.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0700325
Method of observation
Beschreibung

Indicates the mechanism used to perform the observation. Only used if not implicit in code for Observation.code. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-methods.html

Datentyp

text

Alias
UMLS CUI [1,1]
C2911685
UMLS CUI [1,2]
C1554188
Specimen
Beschreibung

The specimen that was used when this observation was made. Should only be used if not implicit in code found in Observation.code

Datentyp

text

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1554188
Observation device
Beschreibung

The device used to generate the observation data.

Datentyp

text

Alias
UMLS CUI [1,1]
C0302523
UMLS CUI [1,2]
C0699733
Observation of a group member
Beschreibung

This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

Datentyp

text

Alias
UMLS CUI [1,1]
C0682343
UMLS CUI [1,2]
C1554188
Target resource from which this observation value is derived
Beschreibung

The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

Datentyp

text

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0035201
UMLS CUI [1,3]
C1554188
Observation Reference Range
Beschreibung

Observation Reference Range

Alias
UMLS CUI-1
C0883335
UMLS CUI-2
C1554188
Reference range to interpret the value
Beschreibung

Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

Datentyp

text

Alias
UMLS CUI [1]
C0883335
Low reference range
Beschreibung

The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

Datentyp

text

Alias
UMLS CUI [1]
C2346904
High reference range
Beschreibung

The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

Datentyp

text

Alias
UMLS CUI [1]
C2348973
Reference range type
Beschreibung

Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range. This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed. https://www.hl7.org/fhir/valueset-referencerange-meaning.html

Datentyp

text

Alias
UMLS CUI [1,1]
C0883335
UMLS CUI [1,2]
C0332307
Target population of the reference range
Beschreibung

Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-referencerange-appliesto.html

Datentyp

text

Alias
UMLS CUI [1,1]
C0883335
UMLS CUI [1,2]
C0039309
Age at which this reference range is applicable
Beschreibung

The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

Datentyp

text

Alias
UMLS CUI [1,1]
C1706839
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0883335
Reference range text
Beschreibung

Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

Datentyp

text

Alias
UMLS CUI [1,1]
C1527021
UMLS CUI [1,2]
C0883335
Observation component
Beschreibung

Observation component

Alias
UMLS CUI-1
C1554188
UMLS CUI-2
C1705248
Observation component
Beschreibung

Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

Datentyp

text

Alias
UMLS CUI [1,1]
C1554188
UMLS CUI [1,2]
C1705248
Component code
Beschreibung

Describes what was observed. Sometimes this is called the observation "code". The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-codes.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C0805701
Component value
Beschreibung

The information determined as a result of making the observation, if the information has a simple value.

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C0042294
Reason for missing value in Component value
Beschreibung

Provides a reason why the expected value in the element Observation.component.value[x] is missing. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-data-absent-reason.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C0042294
UMLS CUI [1,3]
C1709044
Genetic component observation interpretation
Beschreibung

Codes that specify interpretation of genetic analysis, such as "positive", "negative", "carrier", "responsive", etc. 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. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C2711437
UMLS CUI [1,3]
C1554188
UMLS CUI [1,4]
C0796344
Component interpretation of change
Beschreibung

Interpretations of change of quantity and/or severity. At most one of B or W and one of U or D allowed. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C2711437
UMLS CUI [1,3]
C1554188
UMLS CUI [1,4]
C4319952
Component exceptions of interpretation
Beschreibung

Technical exceptions resulting in the inability to provide an interpretation. At most one allowed. Does not imply normality or severity. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C2711437
UMLS CUI [1,4]
C1554188
Component interpretation of normality
Beschreibung

Interpretation of normality or degree of abnormality (including critical or "alert" level). Concepts in this category are mutually exclusive, i.e., at most one is allowed. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C0949333
UMLS CUI [1,3]
C2711437
UMLS CUI [1,4]
C1554188
Component interpretation of susceptibility
Beschreibung

Interpretations of anti-microbial susceptibility testing results (microbiology). At most one allowed. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C0750491
UMLS CUI [1,3]
C2711437
UMLS CUI [1,4]
C1554188
Interpretations of the presence or absence of a component
Beschreibung

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 "meaning" of the quantitative value for the same observation. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C1511790
UMLS CUI [1,3]
C2711437
UMLS CUI [1,4]
C1554188
Component interpretation of the observed result taking into account additional information
Beschreibung

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. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C0679138
UMLS CUI [1,3]
C2711437
UMLS CUI [1,4]
C1554188
Interpretations of the presence and level of reactivity of the specified component
Beschreibung

Interpretations of the presence and level of reactivity of the specified component / analyte with the reagent in the performed laboratory test. The corresponding value set can be found at https://www.hl7.org/fhir/valueset-observation-interpretation.html

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C1511790
UMLS CUI [1,3]
C2711437
UMLS CUI [1,4]
C1554188
Component reference range
Beschreibung

Guidance on how to interpret the value by comparison to a normal or recommended range.

Datentyp

text

Alias
UMLS CUI [1,1]
C1705248
UMLS CUI [1,2]
C0883335
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Ähnliche Modelle

Resource Observation

1 Formulare
  1. StudyEvent: ODM
    1. Resource Observation
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Observation
C1554188 (UMLS CUI-1)
Observation.identifier
Item
Observation identifier
text
C1554188 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Observation.basedOn
Item
Observation basis
text
C1554188 (UMLS CUI [1,1])
C1527178 (UMLS CUI [1,2])
Observation.partOf
Item
If observation is part of a larger event, please fill in
text
C1554188 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Item
Observation status
text
C1554188 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Observation status
Code List
Observation status
CL Item
registered (registered)
The existence of the observation is registered, but there is no result yet available. (Comment:en)
CL Item
preliminary  (preliminary)
This is an initial or interim observation: data may be incomplete or unverified. (Comment:en)
CL Item
final  (final)
The observation is complete and there are no further actions needed. Additional information such "released", "signed", etc would be represented using [Provenance](provenance.html) which provides not only the act but also the actors and dates and other related data. These act states would be associated with an observation status of `preliminary` until they are all completed and then a status of `final` would be applied. (Comment:en)
CL Item
amended (amended)
Subsequent to being Final, the observation has been modified subsequent. This includes updates/new information and corrections. (Comment:en)
CL Item
corrected  (corrected)
Subsequent to being Final, the observation has been modified to correct an error in the test result. (Comment:en)
CL Item
cancelled  (cancelled)
The observation is unavailable because the measurement was not started or not completed (also sometimes called "aborted"). (Comment:en)
CL Item
entered-in-error (entered-in-error)
The observation has been withdrawn following previous final release. This electronic record should never have existed, though it is possible that real-world decisions were based on it. (If real-world activity has occurred, the status should be "cancelled" rather than "entered-in-error".). (Comment:en)
CL Item
unknown (unknown)
The authoring/source system does not know which of the status values currently applies for this observation. Note: This concept is not to be used for "other" - one of the listed statuses is presumed to apply, but the authoring/source system does not know which. (Comment:en)
Item
Observation category
text
C1554188 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Observation category
Code List
Observation category
CL Item
social-history (social-history)
Social History Observations define the patient's occupational, personal (e.g., lifestyle), social, familial, and environmental history and health risk factors that may impact the patient's health. (Comment:en)
CL Item
vital-signs (vital-signs)
Clinical observations measure the body's basic functions such as blood pressure, heart rate, respiratory rate, height, weight, body mass index, head circumference, pulse oximetry, temperature, and body surface area. (Comment:en)
CL Item
imaging (imaging)
Observations generated by imaging. The scope includes observations regarding plain x-ray, ultrasound, CT, MRI, angiography, echocardiography, and nuclear medicine. (Comment:en)
CL Item
laboratory (laboratory)
The results of observations generated by laboratories. Laboratory results are typically generated by laboratories providing analytic services in areas such as chemistry, hematology, serology, histology, cytology, anatomic pathology (including digital pathology), microbiology, and/or virology. These observations are based on analysis of specimens obtained from the patient and submitted to the laboratory. (Comment:en)
CL Item
procedure  (procedure)
Observations generated by other procedures. This category includes observations resulting from interventional and non-interventional procedures excluding laboratory and imaging (e.g., cardiology catheterization, endoscopy, electrodiagnostics, etc.). Procedure results are typically generated by a clinician to provide more granular information about component observations made during a procedure. An example would be when a gastroenterologist reports the size of a polyp observed during a colonoscopy. (Comment:en)
CL Item
survey (survey)
Assessment tool/survey instrument observations (e.g., Apgar Scores, Montreal Cognitive Assessment (MoCA)). (Comment:en)
CL Item
exam  (exam)
Observations generated by physical exam findings including direct observations made by a clinician and use of simple instruments and the result of simple maneuvers performed directly on the patient's body. (Comment:en)
CL Item
therapy (therapy)
Observations generated by non-interventional treatment protocols (e.g. occupational, physical, radiation, nutritional and medication therapy) (Comment:en)
CL Item
activity (activity)
Observations that measure or record any bodily activity that enhances or maintains physical fitness and overall health and wellness. Not under direct supervision of practitioner such as a physical therapist. (e.g., laps swum, steps, sleep data) (Comment:en)
Observation.code
Item
Observation code
text
C1554188 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Observation.subject
Item
Observation subject
text
C0681850 (UMLS CUI [1,1])
C1554188 (UMLS CUI [1,2])
Observation.focus
Item
Focus of observation
text
C1554188 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
Observation.encounter
Item
Encounter
text
C1947978 (UMLS CUI [1,1])
C1554188 (UMLS CUI [1,2])
Observation.effective[x]
Item
Relevant time of an observed value
datetime
C0302523 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Observation.issued
Item
Date and time this observation was issued to providers
datetime
C1554188 (UMLS CUI [1,1])
C4684787 (UMLS CUI [1,2])
Observation.performer
Item
Performer of observation
text
C1554188 (UMLS CUI [1,1])
C1552014 (UMLS CUI [1,2])
Observation.value[x]
Item
Value of observation
text
C1554188 (UMLS CUI [1,1])
C1301772 (UMLS CUI [1,2])
Item
Reason for absent data during observation
text
C0332197 (UMLS CUI [1,1])
C1554188 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,3])
Absent Data
Code List
Reason for absent data during observation
CL Item
Unknown  (unknown)
The value is expected to exist but is not known. (Comment:en)
CL Item
Asked But Unknown  (asked-unknown)
The source was asked but does not know the value. (Comment:en)
CL Item
Temporarily Unknown  (temp-unknown)
There is reason to expect (from the workflow) that the value may become known. (Comment:en)
CL Item
Not Asked  (not-asked)
The workflow didn't lead to this value being known. (Comment:en)
CL Item
Asked But Declined  (asked-declined)
The source was asked but declined to answer. (Comment:en)
CL Item
Masked (masked)
The information is not available due to security, privacy or related reasons. (Comment:en)
CL Item
Not Applicable  (not-applicable)
There is no proper value for this element (e.g. last menstrual period for a male). (Comment:en)
CL Item
Unsupported (unsupported)
The source system wasn't capable of supporting this element. (Comment:en)
CL Item
As Text  (as-text)
The content of the data is represented in the resource narrative. (Comment:en)
CL Item
Error (error)
Some system or workflow process error means that the information is not available. (Comment:en)
CL Item
Not a Number (NaN)  (not-a-number)
The numeric value is undefined or unrepresentable due to a floating point processing error. (Comment:en)
CL Item
Negative Infinity (NINF)  (negative-infinity)
The numeric value is excessively low and unrepresentable due to a floating point processing error. (Comment:en)
CL Item
Positive Infinity (PINF)  (positive-infinity)
The numeric value is excessively high and unrepresentable due to a floating point processing error. (Comment:en)
CL Item
Not Performed  (not-perfomed)
The value is not available because the observation procedure (test, etc.) was not performed. (Comment:en)
CL Item
Not Permitted  (not-permitted)
The value is not permitted in this context (e.g. due to profiles, or the base data types). (Comment:en)
Item
Codes that specify interpretation of genetic analysis
text
C2711437 (UMLS CUI [1,1])
C1554188 (UMLS CUI [1,2])
C0796344 (UMLS CUI [1,3])
Interpretation
Code List
Codes that specify interpretation of genetic analysis
CL Item
Carrier (CAR)
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. (Comment:en)
Item
Interpretation of change
text
C2711437 (UMLS CUI [1,1])
C1554188 (UMLS CUI [1,2])
C4319952 (UMLS CUI [1,3])
Interpretation
Code List
Interpretation of change
CL Item
Better (B)
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.] (Comment:en)
CL Item
Significant change down  (D)
The current result has decreased from the previous result for a quantitative observation (the change is significant as defined in the respective test procedure). (Comment:en)
CL Item
Significant change up  (U)
The current result has increased from the previous result for a quantitative observation (the change is significant as defined in the respective test procedure). (Comment:en)
CL Item
Worse  (W)
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.] (Comment:en)
Item
Exceptions of interpretation
text
C1705847 (UMLS CUI [1,1])
C2711437 (UMLS CUI [1,2])
C1554188 (UMLS CUI [1,3])
Interpretation
Code List
Exceptions of interpretation
CL Item
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. (Comment:en)
CL Item
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. (Comment:en)
CL Item
Insufficient evidence  (IE)
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 "IE" and/or a comment may be reported (without an accompanying S, I or R-categorization).] (Comment:en)
Item
Interpretation of normality
text
C0949333 (UMLS CUI [1,1])
C2711437 (UMLS CUI [1,2])
C1554188 (UMLS CUI [1,3])
Interpretation
Code List
Interpretation of normality
CL Item
Abnormal  (A)
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.] (Comment:en)
CL Item
Critical abnormal  (AA)
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.] (Comment:en)
CL Item
Critical high  (HH)
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. (Comment:en)
CL Item
Critical low  (LL)
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. (Comment:en)
CL Item
High  (H)
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 (Comment:en)
CL Item
Significantly high  (HU)
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. (Comment:en)
CL Item
Low (L)
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 (Comment:en)
CL Item
Significantly low  (LU)
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. (Comment:en)
CL Item
Normal  (N)
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.] (Comment:en)
Item
Interpretation of anti-microbial susceptibility testing results
text
C0750491 (UMLS CUI [1,1])
C2711437 (UMLS CUI [1,2])
C1554188 (UMLS CUI [1,3])
Interpretation
Code List
Interpretation of anti-microbial susceptibility testing results
CL Item
Intermediate (I)
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).] (Comment:en)
CL Item
No CLSI defined breakpoint  (NCL)
Use when not enough clinical trial data published by the Clinical and Laboratory Standards Institutes (CLSI) is available to establish the breakpoints for susceptible / intermediate and resistant. (Comment:en)
CL Item
Non-susceptible  (NS)
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 "nonsusceptible" category, organism identification and antimicrobial susceptibility test results should be confirmed. Synonym: decreased susceptibility. (Comment:en)
CL Item
Resistant (R)
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).] (Comment:en)
CL Item
Synergy - resistant  (SYN-R)
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. (Comment:en)
CL Item
Susceptible (S)
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).] (Comment:en)
CL Item
Susceptible-dose dependent  (SDD)
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. (Comment:en)
CL Item
Synergy - susceptible  (SYN-S)
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. (Comment:en)
CL Item
outside threshold  (EX)
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 "030103C_VOCAB_RCRIM_l_quade_RCRIM Obs Interp_20051028154455". 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. (Comment:en)
CL Item
above high threshold  (HX)
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 "030103C_VOCAB_RCRIM_l_quade_RCRIM Obs Interp_20051028154455". 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. (Comment:en)
CL Item
below low threshold  (LX)
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 "030103C_VOCAB_RCRIM_l_quade_RCRIM Obs Interp_20051028154455". 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. (Comment:en)
Item
Interpretations of the presence or absence of a component
text
C1511790 (UMLS CUI [1,1])
C2711437 (UMLS CUI [1,2])
C1554188 (UMLS CUI [1,3])
Interpretation
Code List
Interpretations of the presence or absence of a component
CL Item
Indeterminate (IND)
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 "indeterminate" (i.e. "cannot be determined") is the appropriate response, not "equivocal". (Comment:en)
CL Item
Equivocal  (E)
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. (Comment:en)
CL Item
Negative  (NEG)
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.] (Comment:en)
CL Item
Not detected  (ND)
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. (Comment:en)
CL Item
Positive (POS)
A presence finding of the specified component / analyte, organism or clinical sign based on the established threshold of the performed test or procedure. (Comment:en)
CL Item
Detected (DET)
The measurement of the specified component / analyte, organism or clinical sign above the limit of detection of the performed test or procedure. (Comment:en)
Item
Interpretation of the observed result taking into account additional information
text
C0679138 (UMLS CUI [1,1])
C2711437 (UMLS CUI [1,2])
C1554188 (UMLS CUI [1,3])
Interpretation
Code List
Interpretation of the observed result taking into account additional information
CL Item
Expected (EXP)
This result has been evaluated in light of known contraindicators. Once those contraindicators have been taken into account the result is determined to be "Expected" (e.g., presence of drugs in a patient that is taking prescription medication for pain management). (Comment:en)
CL Item
Unexpected  (UNE)
This result has been evaluated in light of known contraindicators. Once those contraindicators have been taken into account the result is determined to be "Unexpected" (e.g., presence of non-prescribed drugs in a patient that is taking prescription medication for pain management). (Comment:en)
Item
Interpretation of the presence and level of reactivity of the specified component
text
C1511790 (UMLS CUI [1,1])
C2711437 (UMLS CUI [1,2])
C1554188 (UMLS CUI [1,3])
Interpretation
Code List
Interpretation of the presence and level of reactivity of the specified component
CL Item
Non-reactive  (NR)
An absence finding used to indicate that the specified component / analyte did not react measurably with the reagent. (Comment:en)
CL Item
Reactive (RR)
A presence finding used to indicate that the specified component / analyte reacted with the reagent above the reliably measurable limit of the performed test. (Comment:en)
CL Item
Weakly reactive (WR)
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. (Comment:en)
Observation.note
Item
Comments about the observation or the results
text
C1317574 (UMLS CUI [1,1])
C1554188 (UMLS CUI [1,2])
C1317574 (UMLS CUI [2,1])
C1274040 (UMLS CUI [2,2])
Observation.bodySite
Item
Site on the subject's body where observation was made
text
C1515974 (UMLS CUI [1,1])
C0700325 (UMLS CUI [1,2])
Observation.method
Item
Method of observation
text
C2911685 (UMLS CUI [1,1])
C1554188 (UMLS CUI [1,2])
Observation.specimen
Item
Specimen
text
C0370003 (UMLS CUI [1,1])
C1554188 (UMLS CUI [1,2])
Observation.device
Item
Observation device
text
C0302523 (UMLS CUI [1,1])
C0699733 (UMLS CUI [1,2])
Observation.hasMember
Item
Observation of a group member
text
C0682343 (UMLS CUI [1,1])
C1554188 (UMLS CUI [1,2])
Observation.derivedFrom
Item
Target resource from which this observation value is derived
text
C1521840 (UMLS CUI [1,1])
C0035201 (UMLS CUI [1,2])
C1554188 (UMLS CUI [1,3])
Item Group
Observation Reference Range
C0883335 (UMLS CUI-1)
C1554188 (UMLS CUI-2)
Observation.referenceRange
Item
Reference range to interpret the value
text
C0883335 (UMLS CUI [1])
Observation.referenceRange.low
Item
Low reference range
text
C2346904 (UMLS CUI [1])
Observation.referenceRange.high
Item
High reference range
text
C2348973 (UMLS CUI [1])
Item
Reference range type
text
C0883335 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Reference range type
Code List
Reference range type
CL Item
Normal Range  (normal)
Values expected for a normal member of the relevant control population being measured. Typically each results producer such as a laboratory has specific normal ranges and they are usually defined as within two standard deviations from the mean and account for 95.45% of this population. (Comment:en)
CL Item
Recommended Range (recommended)
The range that is recommended by a relevant professional body. (Comment:en)
CL Item
Treatment Range  (treatment)
The range at which treatment would/should be considered. (Comment:en)
CL Item
Therapeutic Desired Level  (therapeutic)
The optimal range for best therapeutic outcomes. (Comment:en)
CL Item
Pre Therapeutic Desired Level  (pre)
The optimal range for best therapeutic outcomes for a specimen taken immediately before administration. (Comment:en)
CL Item
Therapeutic Desired Level- Post Therapeutic Desired Level  (post)
The optimal range for best therapeutic outcomes for a specimen taken immediately after administration. (Comment:en)
CL Item
Pre-Puberty  (pre-puberty)
An expected range in an individual prior to puberty. (Comment:en)
CL Item
Follicular Stage  (follicular)
An expected range in an individual during the follicular stage of the cycle. (Comment:en)
CL Item
MidCycle  (midcycle)
An expected range in an individual during the midcycle stage of the cycle. (Comment:en)
CL Item
Luteal (luteal)
An expected range in an individual during the luteal stage of the cycle. (Comment:en)
CL Item
Post-Menopause (postmenopausal)
An expected range in an individual post-menopause. (Comment:en)
Observation.referenceRange.appliesTo
Item
Target population of the reference range
text
C0883335 (UMLS CUI [1,1])
C0039309 (UMLS CUI [1,2])
Observation.referenceRange.age
Item
Age at which this reference range is applicable
text
C1706839 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0883335 (UMLS CUI [1,3])
Observation.referenceRange.text
Item
Reference range text
text
C1527021 (UMLS CUI [1,1])
C0883335 (UMLS CUI [1,2])
Item Group
Observation component
C1554188 (UMLS CUI-1)
C1705248 (UMLS CUI-2)
Observation.component
Item
Observation component
text
C1554188 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
Observation.component.code
Item
Component code
text
C1705248 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Observation.component.value[x]
Item
Component value
text
C1705248 (UMLS CUI [1,1])
C0042294 (UMLS CUI [1,2])
Item
Reason for missing value in Component value
text
C1705248 (UMLS CUI [1,1])
C0042294 (UMLS CUI [1,2])
C1709044 (UMLS CUI [1,3])
Component Data - Absent reason
Code List
Reason for missing value in Component value
CL Item
Unknown (unknown)
The value is expected to exist but is not known. (Comment:en)
CL Item
Asked But Unknown  (asked-unknown)
The source was asked but does not know the value. (Comment:en)
CL Item
Temporarily Unknown  (temp-unknown)
There is reason to expect (from the workflow) that the value may become known. (Comment:en)
CL Item
Not Asked  (not-asked)
The workflow didn't lead to this value being known. (Comment:en)
CL Item
Asked But Declined  (asked-declined)
The source was asked but declined to answer. (Comment:en)
CL Item
Masked (masked)
The information is not available due to security, privacy or related reasons. (Comment:en)
CL Item
Not Applicable  (not-applicable)
There is no proper value for this element (e.g. last menstrual period for a male). (Comment:en)
CL Item
Unsupported  (unsupported)
The source system wasn't capable of supporting this element. (Comment:en)
CL Item
As Text  (as-text)
The content of the data is represented in the resource narrative. (Comment:en)
CL Item
Error  (error)
Some system or workflow process error means that the information is not available. (Comment:en)
CL Item
Not a Number (NaN)  (not-a-number)
The numeric value is undefined or unrepresentable due to a floating point processing error. (Comment:en)
CL Item
Negative Infinity (NINF)  (negative-infinity)
The numeric value is excessively low and unrepresentable due to a floating point processing error. (Comment:en)
CL Item
Positive Infinity (PINF)  (positive-infinity)
The numeric value is excessively high and unrepresentable due to a floating point processing error. (Comment:en)
CL Item
Not Performed  (not-performed)
The value is not available because the observation procedure (test, etc.) was not performed. (Comment:en)
CL Item
Not Permitted  (not-permitted)
The value is not permitted in this context (e.g. due to profiles, or the base data types). (Comment:en)
Item
Genetic component observation interpretation
text
C1705248 (UMLS CUI [1,1])
C2711437 (UMLS CUI [1,2])
C1554188 (UMLS CUI [1,3])
C0796344 (UMLS CUI [1,4])
Interpretation
Code List
Genetic component observation interpretation
CL Item
Carrier (CAR)
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. (Comment:en)
Item
Component interpretation of change
text
C1705248 (UMLS CUI [1,1])
C2711437 (UMLS CUI [1,2])
C1554188 (UMLS CUI [1,3])
C4319952 (UMLS CUI [1,4])
Interpretation
Code List
Component interpretation of change
CL Item
Better (B)
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.] (Comment:en)
CL Item
Significant change down  (D)
The current result has decreased from the previous result for a quantitative observation (the change is significant as defined in the respective test procedure). (Comment:en)
CL Item
Significant change up  (U)
The current result has increased from the previous result for a quantitative observation (the change is significant as defined in the respective test procedure). (Comment:en)
CL Item
Worse  (W)
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.] (Comment:en)
Item
Component exceptions of interpretation
text
C1705248 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C2711437 (UMLS CUI [1,3])
C1554188 (UMLS CUI [1,4])
Interpretation
Code List
Component exceptions of interpretation
CL Item
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. (Comment:en)
CL Item
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. (Comment:en)
CL Item
Insufficient evidence  (IE)
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 "IE" and/or a comment may be reported (without an accompanying S, I or R-categorization).] (Comment:en)
Item
Component interpretation of normality
text
C1705248 (UMLS CUI [1,1])
C0949333 (UMLS CUI [1,2])
C2711437 (UMLS CUI [1,3])
C1554188 (UMLS CUI [1,4])
Interpretation
Code List
Component interpretation of normality
CL Item
Abnormal  (A)
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.] (Comment:en)
CL Item
Critical abnormal  (AA)
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.] (Comment:en)
CL Item
Critical high  (HH)
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. (Comment:en)
CL Item
Critical low  (LL)
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. (Comment:en)
CL Item
High  (H)
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 (Comment:en)
CL Item
Significantly high  (HU)
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. (Comment:en)
CL Item
Low (L)
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 (Comment:en)
CL Item
Significantly low  (LU)
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. (Comment:en)
CL Item
Normal  (N)
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.] (Comment:en)
Item
Component interpretation of susceptibility
text
C1705248 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C2711437 (UMLS CUI [1,3])
C1554188 (UMLS CUI [1,4])
Interpretation
Code List
Component interpretation of susceptibility
CL Item
Intermediate (I)
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).] (Comment:en)
CL Item
No CLSI defined breakpoint  (NCL)
Use when not enough clinical trial data published by the Clinical and Laboratory Standards Institutes (CLSI) is available to establish the breakpoints for susceptible / intermediate and resistant. (Comment:en)
CL Item
Non-susceptible  (NS)
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 "nonsusceptible" category, organism identification and antimicrobial susceptibility test results should be confirmed. Synonym: decreased susceptibility. (Comment:en)
CL Item
Resistant (R)
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).] (Comment:en)
CL Item
Synergy - resistant  (SYN-R)
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. (Comment:en)
CL Item
Susceptible (S)
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).] (Comment:en)
CL Item
Susceptible-dose dependent  (SDD)
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. (Comment:en)
CL Item
Synergy - susceptible  (SYN-S)
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. (Comment:en)
CL Item
outside threshold  (EX)
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 "030103C_VOCAB_RCRIM_l_quade_RCRIM Obs Interp_20051028154455". 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. (Comment:en)
CL Item
above high threshold  (HX)
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 "030103C_VOCAB_RCRIM_l_quade_RCRIM Obs Interp_20051028154455". 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. (Comment:en)
CL Item
below low threshold  (LX)
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 "030103C_VOCAB_RCRIM_l_quade_RCRIM Obs Interp_20051028154455". 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. (Comment:en)
Item
Interpretations of the presence or absence of a component
text
C1705248 (UMLS CUI [1,1])
C1511790 (UMLS CUI [1,2])
C2711437 (UMLS CUI [1,3])
C1554188 (UMLS CUI [1,4])
Interpretation
Code List
Interpretations of the presence or absence of a component
CL Item
Indeterminate (IND)
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 "indeterminate" (i.e. "cannot be determined") is the appropriate response, not "equivocal". (Comment:en)
CL Item
Equivocal  (E)
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. (Comment:en)
CL Item
Negative  (NEG)
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.] (Comment:en)
CL Item
Not detected  (ND)
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. (Comment:en)
CL Item
Positive (POS)
A presence finding of the specified component / analyte, organism or clinical sign based on the established threshold of the performed test or procedure. (Comment:en)
CL Item
Detected (DET)
The measurement of the specified component / analyte, organism or clinical sign above the limit of detection of the performed test or procedure. (Comment:en)
Item
Component interpretation of the observed result taking into account additional information
text
C1705248 (UMLS CUI [1,1])
C0679138 (UMLS CUI [1,2])
C2711437 (UMLS CUI [1,3])
C1554188 (UMLS CUI [1,4])
Interpretation
Code List
Component interpretation of the observed result taking into account additional information
CL Item
Expected (EXP)
This result has been evaluated in light of known contraindicators. Once those contraindicators have been taken into account the result is determined to be "Expected" (e.g., presence of drugs in a patient that is taking prescription medication for pain management). (Comment:en)
CL Item
Unexpected  (UNE)
This result has been evaluated in light of known contraindicators. Once those contraindicators have been taken into account the result is determined to be "Unexpected" (e.g., presence of non-prescribed drugs in a patient that is taking prescription medication for pain management). (Comment:en)
Item
Interpretations of the presence and level of reactivity of the specified component
text
C1705248 (UMLS CUI [1,1])
C1511790 (UMLS CUI [1,2])
C2711437 (UMLS CUI [1,3])
C1554188 (UMLS CUI [1,4])
Interpretation
Code List
Interpretations of the presence and level of reactivity of the specified component
CL Item
Non-reactive  (NR)
An absence finding used to indicate that the specified component / analyte did not react measurably with the reagent. (Comment:en)
CL Item
Reactive (RR)
A presence finding used to indicate that the specified component / analyte reacted with the reagent above the reliably measurable limit of the performed test. (Comment:en)
CL Item
Weakly reactive (WR)
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. (Comment:en)
Observation.component.referenceRange
Item
Component reference range
text
C1705248 (UMLS CUI [1,1])
C0883335 (UMLS CUI [1,2])
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