This page is part of the FHIR Specification (v0.01: Historical Archive Draft). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

LabReport

The findings and interpretation of pathology tests performed on tissues and body fluids. This is typically done in a laboratory but may be done in other environments such as at the point of care.

The relative url is /labreports

Content

<LabReport xmlns="http://www.hl7.org/fhir">
  <id> mand id Master Resource Id, always first in all resources</id>
  <status> mand code Registered|Interim|Final|Amended|Cancelled|Withdrawn</status>
  <issued> mand instant date issed for current status</issued>
  <patient> mand (Patient) The patient the report is about</patient>
  <admission> opt (Admission) Admission Context</admission>
  <laboratory> mand (Organization) Responsible Laboratory</laboratory>
  <reportId> opt id Id for external references to this report</reportId>
  <requestDetail>  <!-- Zero+ -->
   <requestOrderId> opt Identifier Id assigned by requester</requestOrderId>
   <receiverOrderId> opt Identifier Receiver's Id for the request</receiverOrderId>
   <requestTest> Zero+ CodeableConcept Test Requested</requestTest>
   <requester> opt (Agent|Organization) Responsible for request</requester>
   <clinicalInfo> opt (Any) Clinical information provided</clinicalInfo>
  </requestDetail>
  <reportName> mand CodeableConcept Name for the entire report</reportName>
  <service> opt CodeableConcept Biochemistry, Haematology etc</service>
  <diagnosticTime> mand dateTime Effective time of diagnostic report</diagnosticTime>
  <specimen> Zero+ (Specimen) Specimen (incl. time of collection)</specimen>
  <resultGroup>  <!-- One+ -->
   <name> opt CodeableConcept What defines the group</name>
   <specimen> opt (Specimen) Specimen details</specimen>
   <result>  <!-- One+ -->
    <name> opt CodeableConcept Name or code of the result</name>
    <value[x]> opt Quantity|CodeableConcept|Attachment|
              Ratio|Choice|Interval(dateTime)|string Result. [x] = type name</value[x]>
    <flag> opt code + | ++ | +++ | - | -- | --- </flag>
    <status> mand code Registered|Interim|Final|Amended|Cancelled|Withdrawn</status>
    <comments> opt string Comments about result</comments>
    <referenceRange>  <!-- Zero+ -->
     <meaning> opt CodeableConcept The meaning of this range</meaning>
     <range[x]> mand Quantity|Interval(Quantity)|string Reference</range[x]>
    </referenceRange>
   </result>
  </resultGroup>
  <conclusion> opt Narrative Clinical Interpretation of test results</conclusion>
  <codedDiagnosis> Zero+ CodeableConcept Codes for the conclusion</codedDiagnosis>
  <representation> One+ Attachment Entire Report as issued</representation>
  <extensions> opt See Extensions   See Extensions </extensions>
  <text> mand Narrative Text summary of report, for human interpretation</text>
</LabReport>

Schema for LabReport and an example (or formatted for browser)

Terminology Bindings

• LabReport.status and LabReport.resultGroup.result.status are bound to the concept domain LabReportStatus: "The status of a report or result item". Possible values:

  registered	The existence of the result is registered, but there is no result yet available
  interim	This is an initial or interim result: data may be missing or verification not been performed
  final	The result is complete and verified by the responsible pathologist
  amended	The result has been modified subsequent to being Final, and is complete and verified by the responsible pathologist
  cancelled	The result is unavailable because the test was not started or not completed (also sometimes called aborted)
  withdrawn	The result has been withdrawn following previous Final release

• LabReport.requestDetail.requestTest is bound to the concept domain LabRequests: "codes for requestable tests"
• LabReport.reportName is bound to the concept domain LabReportNames: "codes for report names". If an appropriate code exists in LOINC then it should be used
• LabReport.service is bound to the concept domain LabServices: "codes for laboratory services". For example values, see HL7 v2 table 0074
• LabReport.resultGroup.name is bound to the concept domain LabResultGroupNames: "codes for result groups". If an appropriate code exists in LOINC then it should be used
• LabReport.resultGroup.result.name is bound to the concept domain LabResultNames: "codes for results". If an appropriate code exists in LOINC then it should be used
• LabReport.resultGroup.result.value[x] is not bound to a concept domain
• LabReport.resultGroup.result.flag is bound to the concept domain LabResultFlag: "codes for result flags". Possible values:

  -

  --

  ---

  +

  ++

  +++

• LabReport.resultGroup.result.referenceRange.meaning is bound to the concept domain LabReferenceRanges: "Code for the meaning of a reference range"
• LabReport.codedDiagnosis is bound to the concept domain LabDiagnosisCodes: "Codes for laboratory diagnoses". A good candidate for codes is SNOMED-CT

Notes:

• About naming: a laboratory produces "reports" that is a collection of "tests" that produce "results". Clinical consumers call the whole collection "the results". There is much potential confusion around these names. The confusion is worsened because "the report" is sometimes a document which entirely contains narrative, sometimes it is purely atomic data results, and sometimes it's a mix of both.
• The scope of this resource is the laboratory reporting process. While this resource includes some elements that relate to the ordering cycle, these are only included to the degree that it is useful for the final report to refer back to the orders. Different resources are required for supporting the ordering cycle.
• This laboratory report model provides a 3 level structure for the results - a report contains a list of groups, each of which contains a list of results. Results are grouped by either a specimen or a code that indicates that nature of the grouping (e.g. organism isolate/sensitivity or antibody functional testing). While many common lab reports don't need or benefit directly from the group structure, this lab report model imposes the group structure anyway. This means that these lab reports have a single group which has no code on it, and which contains all the results. The advantage of this model is that all the results are found at the same point in the heirarchy, and there is a single point on the heirarchy - the group - that may influence the meaning of the test.
• The element that contains the actual value of the result has a variable name depending on the type. The name is "value" + the type name, ignoring parameters, with a capital on the first letter, e.g. valueInterval or valueString
• The clinical information associated with a request can be a simple text summary, or a reference to another resource
• The diagnosticTime can be inferred from the specimens, if they are provided, but specimen details are often not provided, and the value of diagnosticTime is always important. The value of the diagnosticTime element must be consistent with the speciment collection times
• Applications consuming lab reports must take careful note of updates to lab reports, and particularly note withdrawn reports. A report shouldn't be final until all the results are final or amended. If a report is withdrawn, all the results must be withdrawn by replacing every result value with the Concept "withdrawn" in the internal terminology "Special values" (sid = "urn:hl7-org:sid/fhir/special-values"), and setting the conclusion (if provided) and the text narrative to some text like "This report has been withdrawn". A reason may be provided in the narrative.

Relationship between results, narrative, and synoptic reports

One difficult aspect of the design of this resource can be captured with a simple question: “just what is a result?” There is a wide range of variation in the answers to this question; some respond that a result is inherently measurement based, while others focus on the clinical utility of the data item.

Some practical examples:

• Tumour dimensions in synoptic reports
• Injection volumes in radiology reports
• Phenotypes and genotypes in pathology reports
• Images (Scatter plots, electrophoresis photos, slide photos, chromatograms)

Which of these are results? For this resource, we have chosen to take an inclusive view; any of these things can be a result, as long as they have a formal code or name that has a clinical meaning, and some kind of (possible) value then they can be a result.

Searching Criteria

The following simple search/filter parameters are defined for person:

id	an identifier associated with the report
test	the name or code of either a requested test, the report or a report group
result	the name or code or result value of a result
specimen	Either of the specimens. The parameter is then followed by an additional parameter (separated for a ".") that species search/filter inside specimen
patient	The identity of a patient
laboratory	The identity of an laboratory

The standard search parameters also apply (see Searching).

Formal Definitions

The formal definitions for the elements above. Also available as an XML file.

LabReport
Definition	The findings and interpretation of pathology tests performed on tissues and body fluids. This is typically done in a laboratory but may be done in other environments such as at the point of care
Control	Mandatory, 1..1
Requirements	Use to record any pathology test result, including the result of a test on a specimen taken as part of a composite procedure or operation.
Comments	Not to be used for reporting on non-pathology test results e.g. diagnostic imaging, ECG or respiratory function tests. Not to be used to represent an entire cumulative report. This Pathology test result archetype represents only one of the result sets that is usually viewed as a vertical in a cumulative test report. A cumulative report is a view that is constructed from the results represented by multiple OBSERVATION archetypes. This archetype is suitable for representation of general pathology test results, but not intended to cover full synoptic reports. For these, additional resources are required to represent the data properly
RIM Mapping	Observation[isNormalAct() and subsumesCode("ActClass#OBS", classCode) and moodCode="EVN" and domainMember("LabObservationType", code)]
LabReport.id
Definition	Master Resource Id, always first in all resources
Control	Mandatory, 1..1
Type	id
RIM Mapping	unique(./id[isNormalDatatype() and displayable="false" and scope="OBJ" and reliability="ISS"])
LabReport.status
Definition	The status of the pathology test result as a whole
Control	Mandatory, 1..1
Type	code from LabReportStatus
Must Understand	true
Requirements	Labs routinely issue provisional/incomplete reports, or withdraw previously released reports
RIM Mapping	registered: ./statusCode[isNormalDatatype()]="new"; interim: ./statusCode[isNormalDatatype()]="active"; final: ./statusCode[isNormalDatatype()]="complete" and not(./inboundRelationship[typeCode="SUBJ" and isNormalActRelationship()]/source[subsumesCode("ActClass#CACT") and moodCode="EVN" and domainMember("ReviseLabOrder", code) and isNormalAct()]); amended: ./statusCode[isNormalDatatype()]="complete" and ./inboundRelationship[typeCode="SUBJ" and isNormalActRelationship()]/source[subsumesCode("ActClass#CACT") and moodCode="EVN" and domainMember("ReviseLabOrder", code) and isNormalAct() and statusCode="completed"]; cancelled: ./statusCode[isNormalDatatype()]="aborted"; withdrawn: ./statusCode[isNormalDatatype()]="obsolete"
LabReport.issued
Definition	The date and/or time that the result was issued from the source for the recorded ‘Test result status
Control	Mandatory, 1..1
Type	instant
Must Understand	true
Requirements	Clinicians need to be able to check the date that the report was released
Comments	May be different from LabReport.updated, because that is the status of this record, not the report the record is about
RIM Mapping	firstOf(unique(./participation[isHighest(priorityCode) and typeCode="VRF" and isNormalParticipation()]/time[type="TS"]), unique(./participation[isHighest(priorityCode) and typeCode="AUT" and isNormalParticipation()]/time[type="TS"]))
LabReport.patient
Definition	The patient about who the report is about
Control	Mandatory, 1..1
Type	Resource(Patient)
Must Understand	true
Requirements	Must know the patient context
RIM Mapping	unique(./participation[isHighest(priorityCode) and typeCode="SBJ" and isNormalParticipation()]/role[classCode="PAT"])
To Do	need to check the wording -is it about, upon, for?
LabReport.admission
Definition	The admission that this diagnostic investigation is associated with
Control	Optional, 0..1
Type	Resource(Admission)
Requirements	Some institutions track and file diagnostic reports under a specific admission
RIM Mapping	unique(./inboundRelationship[isHighest(priorityCode) and typeCode="SUBJ" and isNormalActRelationship()]/source[subsumesCode("ActClass#ENC", code) and moodCode="EVN" and isNormalAct()])
To Do	Reckon this is not 80%
LabReport.laboratory
Definition	The laboratory service that issued the report
Control	Mandatory, 1..1
Type	Resource(Organization)
Requirements	Need to know how to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis
Comments	This is not necessarily the source of the atomic reports - it's the lab that takes responsibility for the clinical report
RIM Mapping	unique(./participation[isHighest(priorityCode) and typeCode="AUT" and isNormalParticipation()]/role[subsumesCode("RoleClass#ASSIGN", classCode)]/scoper[subsumesCode("EntityClass#ORG", classCode) and determinerCode="INSTANCE"])
LabReport.reportId
Definition	The local ID assigned to the report by the order filler, usually by the Laboratory Information System (LIS).
Control	Optional, 0..1
Type	id
Requirements	Need to know what identifier to use when making queries about this report from the source laboratory
RIM Mapping	unique(./id[displayable="true" and scope="OBJ"])
LabReport.requestDetail
Definition	Details concerning a single pathology test requested.
Control	0..*
Requirements	Need to be able to track completion of requests based on reports issued, and also to report what diagnostic test swere requested (not always the same as what is delivered)
Comments	Note: Usually there is one test request for each result, however in some circumstances multiple test requests may be represented using a single Pathology test result resource
RIM Mapping	unique(./outboundRelationship[typeCode="FLFS" and isNormalActRelationship()]/target[subsumesCode("ActClass#OBS", classCode) and subsumes("ActMood#PRMS", moodCode) and isNormalAct()])
LabReport.requestDetail.requestOrderId
Definition	The local ID assigned to the order by the order requester.
Control	Optional, 0..1
Type	Identifier
Requirements	Need to be able to track completion of requests based on reports issued
Comments	Equivalent to the Placer Order Identifier
RIM Mapping	unique(./outboundRelationship[typeCode="FLFS" and isNormalActRelationship()]/target[subsumesCode("ActClass#OBS", classCode) and subsumes("ActMood#RQO", moodCode) and isNormalAct()]/id[scope="OBJ" and displayable="true"])
To Do	Reckon this is not 80%
LabReport.requestDetail.receiverOrderId
Definition	The local ID assigned to the test order by the order filler, usually by the Laboratory Information System (LIS).
Control	Optional, 0..1
Type	Identifier
Requirements	Need to be able to track completion of requests based on reports issued
Comments	Usually equivalent to the DICOM Accession Number and the Filler Order Identifier.
RIM Mapping	unique(./id[scope="OBJ" and displayable="true"])
To Do	Reckon this is not 80%
LabReport.requestDetail.requestTest
Definition	Identification of pathology test requested,
Control	0..*
Type	CodeableConcept from LabRequests
Requirements	Need to be able to report what diagnostic test swere requested (not always the same as what is delivered)
Comments	Useful where the test requested differs from the test actually performed.
RIM Mapping	./code
LabReport.requestDetail.requester
Definition	Details of the clinician or organisation requesting the laboratory test.
Control	Optional, 0..1
Type	Resource(Agent|Organization)
Requirements	The requesting clinician may need to be contacted concerning the interpretation of the lab report
RIM Mapping	Agent: unique(./participation[isHighest(priorityCode) and typeCode="AUT" and isNormalParticipation()]/role[subsumesCode("RoleClass#ASSIGN", classCode)] Organization: unique(./participation[isHighest(priorityCode) and typeCode="AUT" and isNormalParticipation()]/role[subsumesCode("RoleClass#ASSIGN", classCode)]/scoper[subsumesCode("EntityClass#ORG", classCode) and determinerCode="INSTANCE" and code[isNormalDatatype]])
LabReport.requestDetail.clinicalInfo
Definition	Details of the clinical information provided to the laboratory along with the original request
Control	Optional, 0..1
Type	Resource(Any)
Requirements	Knowing the clinical information may influence the interpretation of the result
RIM Mapping	./outboundRelationship[typeCode="PERT" and isNormalActRelationship()]/target
To Do	This isn't really *ANY* resource. You can't send a drug or an Animal or a bunch of other things. What you really want here are "acts", and I suspect there's a constraint that the subject of the LabReport must have participated in them as subject or perhaps in some other way.
LabReport.reportName
Definition	Identification of the pathology test performed, sometimes including specimen type.
Control	Mandatory, 1..1
Type	CodeableConcept from LabReportNames
Must Understand	true
Requirements	Need to know what report this is, so clinicians can filter/find the reports they are looking for
Comments	A test result may be for a single analyte, or a group of items, including panel tests.
RIM Mapping	./code
LabReport.service
Definition	The diagnostic service that performs the examination e.g. biochemistry, haematology.
Control	Optional, 0..1
Type	CodeableConcept from LabServices
Requirements	Help clinicians filter/find the reports they are looking for
RIM Mapping	unique(./inboundRelationship[typeCode="COMP" and isNormalActRelationship()]/source[subsumesCode("ActClass#LIST", classCode) and moodCode="EVN" and inDomain(code,"Lab Service") and isNormalAct()]/code
To Do	I'm not sure this is in the 80%.
LabReport.diagnosticTime
Definition	The diagnostically relevant time for this report
Control	Mandatory, 1..1
Type	dateTime
Must Understand	true
Requirements	Need to know where in the patient history to file/present this report
Comments	The diagnostically relevant time can be derived from the specimen collection times, but the specimen information is not always available, and the exact relationship is not always automatic
RIM Mapping	./effectiveTime[type="TS"]
LabReport.specimen
Definition	Details about the specimen if all individual test results are derived from the same specimen
Control	0..*
Type	Resource(Specimen)
Requirements	Need to be able to report information about the collected specimens on which the report is based
Comments	If the specimen is sufficiently specified with a code in the Test result name, then this additional data may be redundant. If there are multiple specimens, these may be represented per 'Result group'
RIM Mapping	unique(./participation[typeCode="SUBJ" and isNormalParticipation()]/role[subsumesCode("RoleClass#SPEC", classCode)])
LabReport.resultGroup
Definition	A group of results. Results may be grouped by specimen, or by some value in LabReport.resultGroup.name to describe what binds all the results together.
Control	1..*
Must Understand	true
Requirements	Need to be able to report groups of results, where the result grouping is arbitrary, but meaningful
Comments	Many (most) lab reports don't really have a meaningful group. In these cases, just create a single group with no specimen or name
RIM Mapping	./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[isNormalAct() and subsumesCode("ActClass#OBS", classCode) and moodCode="EVN" and fromDomain(code, "LabObservationBattery")]
LabReport.resultGroup.name
Definition	A code or name that describes the group of results
Control	Optional, 0..1
Type	CodeableConcept from LabResultGroupNames
Must Understand	true
Comments	For example, the antibody code for a goup of antibody related test, or the organism code for a group of isolate/sensitivities. Leave blank if there is no particular meaning associated with the group
RIM Mapping	./code
LabReport.resultGroup.specimen
Definition	Details about the individual specimen to which these ‘Result group’ test results refer, where testing of multiple specimens is required.
Control	Optional, 0..1
Type	Resource(Specimen)
Requirements	Need to be able to report information about the collected specimens on which the report is based
RIM Mapping	unique(./participation[typeCode="SBJ" and isNormalParticipation()]/role[subsumesCode("RoleClass#SPEC", classCode)])
LabReport.resultGroup.result
Definition	Specific detailed result, including both the value of the result item, and additional information that may be useful for clinical interpretation. Results include whatever specific data items pathology labs report as part of the clinical service; it is not confined to measurements.
Control	1..*
Must Understand	true
Requirements	Need to report results with information that assist with interpretation
RIM Mapping	./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[subsumesCode("ActClass#OBS", classCode) and moodCode="EVN" and isNormalAct() and fromDomain(code, "LabObservationResult")]
LabReport.resultGroup.result.name
Definition	Identifies the meaning of the value
Control	Optional, 0..1
Type	CodeableConcept from LabResultNames
Must Understand	true
Requirements	Need to know what the result is about
Comments	results are fundamentally a name - value pair with additional clarifying information
RIM Mapping	./code
LabReport.resultGroup.result.value[x]
Definition	Actual value of the result. Most result values will be numerical measurements, but others may be coded concepts, free text, or multimedia images
Control	Optional, 0..1
Type	Quantity|CodeableConcept|Attachment|Ratio|Choice|Interval(dateTime)|string from *unbound*
Must Understand	true
Requirements	Need a value for the result
RIM Mapping	./value
LabReport.resultGroup.result.flag
Definition	Flag indicating the abnormal status of the result
Control	Optional, 0..1
Type	code from LabResultFlag
Must Understand	true
RIM Mapping	./interpretationCode
To Do	The proposed set of codes are too narrow (and doesn't map well to v3.)
LabReport.resultGroup.result.status
Definition	The status of the result value
Control	Mandatory, 1..1
Type	code from LabReportStatus
Must Understand	true
Requirements	Need to track the status of individual results - some results are finalised before the whole report is finalised
RIM Mapping	(as per LabReport.status)
LabReport.resultGroup.result.comments
Definition	May include statements about significant, unexpected or unreliable. values, or information about the source of the value where this may be relevant to the interpretation of the result.
Control	Optional, 0..1
Type	string
Must Understand	true
Requirements	Need to be able to provide free text additional information
RIM Mapping	unique(./inboundRelationship[typeCode="SUBJ" and isNormalActRelationship()]/source[subsumesCode("ActClass#OBS", classCode) and moodCode="EVN" and mapsTo(code, "LOINC# 48767-8") and isNormalAct()]/value[type="ST"])
LabReport.resultGroup.result.referenceRange
Definition	Guidance on how to interpret the value by comparison to a normal or recommended range
Control	0..*
Must Understand	true
Requirements	Need to be able to provide multiple reference ranges
Comments	Most results only have one reference range. Some non-numerical results don't have a reference range
RIM Mapping	./outboundRelationship[typeCode="REFV" and isNormalActRelationship()]/target[subsumesCode("ActClass#OBS", classCode) and moodCode="EVN" and isCriterionInd="true" and isNormalAct()]
To Do	Are multiple reference ranges in the 80%?
LabReport.resultGroup.result.referenceRange.meaning
Definition	Code for the meaning of the reference range
Control	Optional, 0..1
Type	CodeableConcept from LabReferenceRanges
Requirements	Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, or perhaps what state this reference range applies to (i.e. hormonal cycles)
RIM Mapping	./interpretationCode
LabReport.resultGroup.result.referenceRange.range[x]
Definition	Actual value of the reference range. May be a quantity (<20mg/L), an interval (10-20 umol/L), or some text
Control	Mandatory, 1..1
Type	Quantity|Interval(Quantity)|string
Requirements	Need to be able to report numerical or text reference ranges, and handle legacy data
Comments	Text reference ranges are typically used in endocrinology, or for legacy data with string reference ranges
RIM Mapping	./value[type=("PQ", "IVL_PQ", "ST")]
LabReport.conclusion
Definition	Concise and clinically contextualised narrative interpretation of the pathology test results.
Control	Optional, 0..1
Type	Narrative
Must Understand	true
Requirements	Need to be able to provide a conclusion that is not lost amongst the basic result data
Comments	common reports don't have a conclusion, but some do
RIM Mapping	unique(./inboundRelationship[typeCode="SPRT" and isNormalActRelationship()]/source[subsumesCode("ActClass#OBS", classCode) and moodCode="EVN" and mapsTo(code, "LOINC# 48767-8") and isNormalAct()]/value[type="ST"])
To Do	Is this in the 80%?
LabReport.codedDiagnosis
Definition	Codes for the conclusion
Control	0..*
Type	CodeableConcept from LabDiagnosisCodes
RIM Mapping	unique(./inboundRelationship[typeCode="SPRT" and isNormalActRelationship()]/source[subsumesCode("ActClass#OBS", classCode) and moodCode="EVN" and subsumesCode(code, "LOINC# 54531-9") and isNormalAct()]/value[type="CD"])
LabReport.representation
Definition	Rich text representation of the entire result as issued by the diagnostic service. Multiple formats are allowed but they must be semantically equivalent.
Control	1..*
Type	Attachment
Must Understand	true
Requirements	Laboratory needs to be able to provide it's own fully formatted report for clinical fidelity
Comments	Possible formats: text/html, text/plain, text/rtf, application/msword, application/pdf, application/rtf, application/vnd.oasis.opendocument.text, application/vnd.openxmlformats-officedocument.wordprocessingml.document
RIM Mapping	./text[type="ED"]
LabReport.extensions
Definition	See Extensions
Control	Optional, 0..1
RIM Mapping	N/A
LabReport.text
Definition	Text summary of report, for human interpretation
Control	Mandatory, 1..1
Type	Narrative
RIM Mapping	unique(./text[type="ST"])

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This is an old version of FHIR retained for archive purposes. Do not use for anything else
Implementers are welcome to experiment with the content defined here, but should note that the contents are subject to change without prior notice.
© HL7.org 2011 - 2012. FHIR v0.01 generated on Mon, May 14, 2012 09:48+1000.