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Template Laboratory Observation 2017‑03‑21 10:38:18

Id2.16.756.5.30.1.1.10.4.3
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ch-palm-
Effective Date2017‑03‑21 10:38:18
Statusdraft DraftVersion Label2017
Namechpalm_entry_LaboratoryObservationDisplay NameLaboratory Observation
Description
Laboratory reports MUST contain at least one laboratory result which is declared using this element. Each laboratory result consists of code, value and interpretation of the result.

Code
For laboratory reports in Switzerland, primarly LOINC and where necessary, additional SNOMED-CT codes MUST be used. At least one laboratory result for a specimen MUST thus contain a LOINC code.
Certain microbiology pathogen detection can not be uniquely identified with LOINC (e.g., Campylobacter coli). Such pathogen detection must be specified in a second observation in the same Laboratory Battery Organizer with a corresponding code from another code system (e.g., SNOMED CT).
For examinations according to the Swiss analysis list (AL), a translation element CAN be specified to establish the reference to the corresponding AL position.
Further translation elements may be added to make reference to other codes, e.g. the locally used code in the laboratory.
TODO schematron to check these busines rules.

Value
The concrete values measured MUST be specified in observation elements as follows (data types according to HL7 CDA):
  • Text findings are declared as free text in the narrative portion of the corresponding section, and the text element MUST contain the corresponding reference to the narrative text. In this case, the observation MAY NOT contain the value element.
  • True / False values are declared using the data type BL.
  • Encoded values are declared using the data type CD.
  • Numeric results are declared using data type PQ in combination with internationally standardized units (UCUM), according to the value set.
  • Ratios are declared with data type RTO.

Interpretation
The interpretation code specifies AT LEAST whether it is a normal result or a result outside the normal range. Further interpretation codes CAN be used.
ClassificationCDA Entry Level Template
Open/ClosedOpen (other than defined elements are allowed)
RelationshipSpecialization: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07)
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Specialization: template 1.3.6.1.4.1.19376.1.3.1.6 (2016‑07‑05)
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ch-palm-
ItemDTCardConfDescriptionLabel
hl7:observation
Laboratory result with interpretation, related previous results, reference range, participants (persons and devices) as well as comments.chpadotstion
@classCode
cs1 … 1FOBS
@moodCode
cs1 … 1FEVN
hl7:templateId
II1 … 1Mchpadotstion
@root
uid1 … 1F1.3.6.1.4.1.19376.1.3.1.6
hl7:id
II0 … 1An ID for this item CAN be filled for traceability.chpadotstion
@extension
st1 … 1RMUST contain the ID itself. The ID MUST be unique within the system that issued the ID.
@root
uid1 … 1RMUST contain the OID of the system that issued the ID. OIDs of code systems, which are published in the public OID registry for the Swiss health care system (oid.refdata.ch) are REQUIRED. Others are NOT ALLOWED.
hl7:code
CD1 … 1MA unique code for this result MUST be specified.chpadotstion
@displayName
st1 … 1RThe displayName of the code MUST be specified for tracking purposes. However, processing is NOT ALLOWED. Instead, a processing system is to display a user readable language translation of the code from the value set.
@codeSystemName
st1 … 1RThe name of the code system MUST be specified for tracking purposes. However, processing is NOT ALLOWED.
@codeSystem
oid1 … 1RThe OID of the code system MUST be specified.
@code
cs1 … 1RThe code MUST be specified.
 CONF
The value of @code shall be drawn from value set 2.16.756.5.30.1.1.11.6 (DYNAMIC)
hl7:translation
CD0 … *Makes reference to the corresponding position of the Swiss analysis list (AL). Multiple references (translation elements) are allowed.chpadotstion
@displayName
st1 … 1RThe displayName of the code MUST be specified for tracking purposes. It MUST correspond to one of the available languages of the Swiss analysis list (AL). However, processing is NOT ALLOWED. Instead, a processing system is to display a user readable language translation of the code from the Swiss analysis list (AL).
@codeSystemName
st1 … 1FSwiss analysis list (AL)
 The name of the code system MUST be specified for tracking purposes. However, processing is NOT ALLOWED.
@codeSystem
oid1 … 1F2.16.756.5.30.1.129.1.3
 The OID of the Swiss analysis list (AL) MUST be specified.
@code
cs1 … 1RThe position number of the Swiss Analysis list MUST be declared.
hl7:translation
CD0 … *Makes reference to other codes, e.g. the locally used code in the laboratory. Multiple references (translation elements) are allowed.chpadotstion
@displayName
st1 … 1RThe displayName of the code MUST be specified for tracking purposes. However, processing is NOT ALLOWED. Instead, a processing system is to display a user readable language translation of the code from the value set.
@codeSystemName
st1 … 1RThe name of the code system MUST be specified for tracking purposes. However, processing is NOT ALLOWED.
@codeSystem
oid1 … 1RThe OID of the code system MUST be specified.
@code
cs1 … 1RThe code MUST be specified.
Included1 … 1 from 2.16.756.5.30.1.1.10.9.14 Narrative Text Reference (DYNAMIC)
The human-readable text MUST be generated automatically from the structured information of this element.
The text element MUST contain the reference to the corresponding text in the human readable part, ONLY.
hl7:text
ED1 … 1MCDA‑CH V2
hl7:reference
TEL1 … 1MThe reference to the corresponding text in the human readable part must be specified by reference to content[@ID]: reference[@value='#xxx']CDA‑CH V2
@value
1 … 1RReference to the narrative part of the section in the format '#xxx', where xxx is the ID of the corresponding element.
 Schematron assertrolered error 
 teststarts-with(@value,'#') 
 MessageThe @value attribute content MUST conform to the format '#xxx', where xxx is the ID of the corresponding 'content' element. 
 Variable letNameidvalue 
 Valuesubstring-after(@value,'#') 
 Schematron assertrolered error 
 testancestor::hl7:structuredBody//*[@ID=$idvalue] 
 MessageNo narrative text found for this reference (no content element within this document has an ID that corresponds to '<value-of select="$idvalue"/>'). 
hl7:statusCode
CS1 … 1MThe status 'completed' means that the result is final.
The status 'aborted' means that the examination could not be performed.
chpadotstion
 CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.19376.1.3.11.2 ActStatusAbortedCompleted (DYNAMIC)
hl7:effectiveTime
IVL_TS.CH.TZ0 … 1C Timestamp of the finding (physiologically relevant time) of this observation. Accuracy of the value: Date and time with hour and minute
This information is ALLOWED for results within an isolate group, ONLY. For all other results, the time specified in the Laboratory Battery Organizer is to be used.
TODO schematron to check these busines rules.
chpadotstion
 Schematron assertrolered error 
 teststring-length(@value)>11 
 MessageA precision of date and time of day with at least hour and minute is required. 
Choice0 … *
The result of the examination MUST be specified for all elements with status 'completed'. One of the following data types MUST be used.
For elements with status 'aborted', the result of the test is NOT ALLOWED.
Elements to choose from:
  • hl7:value
  • hl7:value
  • hl7:value
  • hl7:value
  • hl7:value
  • hl7:value
hl7:value
NPIn the case of microbiological or infection-serological detection of pathogens, NO value element is PERMITTED.
Instead, declare using the interpretationCode whether the pathogen was detected in the sample (POS) or not (NEG).
chpadotstion
hl7:value
BL0 … 1 True / False or Yes / No Result.
If the observation value can not be determined, @value is NOT ALLOWED.
Instead, @nullFlavor='NA' MUST be used in combination with interpretationCode that declares whether the result is below (Low of scale) or above (High of scale) of the reference range.
TODO schematron to check these busines rules.
chpadotstion
@nullFlavor
cs0 … 1FNA
 Observation value could not be determined.
@value
bl0 … 1 true or false.
 Example<value xsi:type="BL" value="false"/>
hl7:value
CD0 … 1 Coded result.
If the observation value can not be determined, @code, @codeSystem, @codeSystemName and @displayName are NOT ALLOWED.
Instead, @nullFlavor='NA' MUST be used in combination with interpretationCode that declares whether the result is below (Low of scale) or above (High of scale) of the reference range.
TODO schematron to check these busines rules.
chpadotstion
@nullFlavor
cs0 … 1FNA
 Observation value could not be determined.
@displayName
st0 … 1 The displayName of the code MUST be specified for tracking purposes. However, processing is NOT ALLOWED. Instead, a processing system is to display a user readable language translation of the code from the value set.
@codeSystemName
st0 … 1 The name of the code system MUST be specified for tracking purposes. However, processing is NOT ALLOWED.
@codeSystem
oid0 … 1 The OID of the code system MUST be specified.
@code
cs0 … 1 The code MUST be specified.
 Example<value xsi:type="CD" code="N" codeSystem="2.16.756.5.30.2.1.1.3.1"/>
hl7:value
ED0 … 1Text result.chpadotstion
 Example<value xsi:type="ED">
  <reference value="#l1"/></value>
hl7:reference
TEL1 … 1MThe reference to the corresponding text in the human readable part must be specified by reference to content[@ID]: reference [@value = '#xxx']chpadotstion
@value
1 … 1RReference to the narrative part of the section in the format '#xxx', where xxx is the ID of the corresponding <content> Element.
hl7:value
PQ0 … 1 Numeric result with unit.
If the observation value can not be determined, @value and @unit are NOT ALLOWED.
Instead, @nullFlavor='NA' MUST be used in combination with interpretationCode that declares whether the result is below (Low of scale) or above (High of scale) of the reference range.
TODO schematron to check these busines rules.
chpadotstion
@nullFlavor
cs0 … 1FNA
 Observation value could not be determined.
@unit
cs0 … 1 Valid UCUM unit.
@value
real0 … 1 Numeric observation result
 Example<value xsi:type="PQ" value="6.4" unit="mg/dL"/>
hl7:value
RTO0 … 1 Ratio results
If the observation value can not be determined, numerator and denominator are NOT ALLOWED.
Instead, @nullFlavor='NA' MUST be used in combination with interpretationCode that declares whether the result is below (Low of scale) or above (High of scale) of the reference range.
TODO schematron to check these busines rules.
chpadotstion
@nullFlavor
cs0 … 1FNA
 Observation value could not be determined.
 Example
Titer
<value xsi:type="RTO">
  <numerator xsi:type="INT" value="1"/>  <denominator xsi:type="INT" value="64"/></value>
hl7:numerator
QTY0 … 1chpadotstion
@value
1 … 1RNumerator of the ratio.
hl7:denominator
QTY0 … 1chpadotstion
@value
1 … 1RDenominator of the ratio.
hl7:interpretationCode
CE0 … 1 At least one interpretation of the result MUST be declared. For this purpose, a code from the HL7 Observation Interpretation vocabulary MUST be used.
Examples of normal results:
  • N: Normal

Examples of pathogen detection:
  • POS: pathogen found in the specimen
  • NEG: pathogen not found in the specimen (No evidence or no growth). Note: Negative does not necessarily imply the complete absence of the specified item.

Examples abnormal results with numeric values:
  • H: High - Above reference range
  • HH: High alert - Above reference range (critical value)
  • L: Low - Below reference range
  • LL: Low alert - Below reference range (critical value)

Examples of non-determinable results:
  • >: High off scale - Above analytical limit
  • <: Low off scale - Below analytical limit

Examples of antimicrobial susceptibility tests in microbiology:
  • S: susceptible
  • R: resistant
  • I: intermediate
  • SDD: Susceptible-dose dependent
chpadotstion
 CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.78 ObservationInterpretation (DYNAMIC)
Choice0 … 1
IF this result is based on a specimen of a non-human material, this MUST be declared with the subject element.
Elements to choose from:
hl7:subject
0 … 1Contains 2.16.756.5.30.1.1.10.4.5 Non-Human Subject - subject Containment (DYNAMIC)chpadotstion
hl7:subject
0 … 1Contains 2.16.756.5.30.1.1.10.4.6 Human Patient with Non-Human Subject - subject Containment (DYNAMIC)chpadotstion
hl7:performer
0 … *This CAN be used to indicate who has performed the test. This information supersedes any information recorded at higher level.
Contains 2.16.756.5.30.1.1.10.4.7 Laboratory Performer - performer Containment (DYNAMIC)
chpadotstion
hl7:author
0 … *This CAN be used to indicate who has documented the result. This information supersedes any information recorded at higher level.
Contains 2.16.756.5.30.1.1.10.9.16 Author Compilation with name, addr and telecom (DYNAMIC)
chpadotstion
Choice0 … *
This CAN be used to identify other parties:
  • Who has verified the result (AUTHEN).
  • Which external laboratory has delivered the result (RESP).
  • Which device (analyzer) was used to determine the result (DEV).
Elements to choose from:
hl7:participant
0 … *Who has verified the result (AUTHEN). This information supersedes any information recorded at higher level.
Contains 2.16.756.5.30.1.1.10.4.8 Laboratory Results Validator - participant Containment (DYNAMIC)
chpadotstion
hl7:participant
0 … *Which external laboratory has delivered the result (RESP). This information supersedes any information recorded at higher level.
Contains 2.16.756.5.30.1.1.10.4.9 Responsible Party - participant Containment (DYNAMIC)
chpadotstion
hl7:participant
0 … *Which device (analyzer) was used to determine the result (DEV). This information supersedes any information recorded at higher level.
Contains 2.16.756.5.30.1.1.10.4.10 Device - participant Containment (DYNAMIC)
chpadotstion
hl7:entryRelationship
0 … *Information on specimen collection for this Observation. This information supersedes any information recorded at higher level.
Contains 2.16.756.5.30.1.1.10.4.11 Specimen Collection (DYNAMIC)
chpadotstion
@typeCode
cs1 … 1FCOMP
hl7:entryRelationship
0 … *Comment on this Observation.
Contains 2.16.756.5.30.1.1.10.4.2 Annotation Comments (DYNAMIC)
chpadotstion
@typeCode
cs1 … 1FSUBJ
@inversionInd
bl1 … 1Ftrue
hl7:entryRelationship
0 … *This CAN be used to indicate previous observation for the same test code on a previous specimen.
Contains 2.16.756.5.30.1.1.10.4.22 Previous Observation (DYNAMIC)
chpadotstion
@typeCode
cs1 … 1FREFR
hl7:sequenceNumber
INT0 … 1In case there is more than one previous result, the entryRelationship elements are sorted in reverse chronological order, and numbered from 1 to n by sequenceNumber.chpadotstion
@value
int0 … 1 Contains the sequence number.
hl7:reference
0 … *This CAN be used to make reference to an external document.
Contains 2.16.756.5.30.1.1.10.4.29 External document (DYNAMIC)
chpadotstion
@typeCode
cs1 … 1FREFR
hl7:referenceRange
0 … 1 The reference range MUST be specified for the range of normal values for the data types PQ and INT. The following applies:
  • Upper limit: [R]
  • Lower limit: [R]
  • interpretationCode containing code=N: [M]

The reference range CAN be omitted for other data types.
If only an upper or lower limit is meaningful, the unused limit MUST be declared using nullFlavor.
TODO schematron to check these busines rules.
chpadotstion
@typeCode
cs1 … 1FREFV
hl7:observationRange
1 … 1Mchpadotstion
@classCode
cs1 … 1FOBS
@moodCode
cs1 … 1FEVN.CRT
Choice0 … 1Elements to choose from:
  • hl7:value[@xsi:type='IVL_PQ']
  • hl7:value[@xsi:type='IVL_INT']
hl7:value
IVL_PQ0 … 1RReference range for PQ data typeschpadotstion
where [@xsi:type='IVL_PQ']
@xsi:type
1 … 1FIVL_PQ
hl7:low
IVXB_PQ1 … 1Lower limit of the reference rangechpadotstion
@value
real1 … 1RLower limit value of the reference range
@unit
cs1 … 1RValid UCUM Unit of the lower limit of the reference range
hl7:high
IVXB_PQ1 … 1Upper limit of the reference rangechpadotstion
@value
real1 … 1RUpper limit value of the reference range
@unit
cs1 … 1RValid UCUM Unit of the upper limit of the reference range
hl7:value
IVL_INT0 … 1RReference range for INT data typeschpadotstion
where [@xsi:type='IVL_INT']
@xsi:type
1 … 1FIVL_INT
hl7:low
IVXB_INT1 … 1Lower limit of the reference rangechpadotstion
@value
int1 … 1RLower limit value of the reference range
@unit
cs1 … 1RValid UCUM Unit of the lower limit of the reference range
hl7:high
IVXB_INT1 … 1Upper limit of the reference rangechpadotstion
@value
int1 … 1RUpper limit value of the reference range
@unit
cs1 … 1RValid UCUM Unit of the upper limit of the reference range
hl7:interpretationCode
CE1 … 1MThis reference range defines normal values.chpadotstion
@code
CONF1 … 1FN