Submitted By: Riki Merrick
/ Association of Public Health Laboratories
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Data Element Information |
Data Element Description |
A categorical assessment of an observation value, often in relation to its clinical context. For example, high, low, normal. |
Rationale for Separate Consideration |
This is related to the Test Result Value element and is closely linked to provide interpretation by a laboratorian about the result value in relation to the reference ranges for the particular patient. it is often used in alerting for patient care. |
Use Case Description(s) |
Use Case Description |
This is a CLIA requirement: §493.1291(c)(6): “The test result and, if applicable, the units of measurement or interpretation, or both.”
Clarification: The corresponding test result value, and interpretation (where available) of that value for the requested analyte/test in numeric or text format [OBX-5].
Where available, the corresponding units of measure for the requested analyte/test identified and used by the performing laboratory [OBX-6]
Where available, the laboratory's interpretation communicated by defined text/symbols indicating test results that do not fall within the established reference/normal range [OBX-8]. The coded values received from the laboratory may be translated in the EHR to an equivalent description prior to display. |
Estimate the breadth of applicability of the use case(s) for this data element
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This is applies to all laboratory tests, so LIS, EHR-s, HIEs, PHR, surveillance systems, decision support systems, disease registries.
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Link to use case project page |
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=98 LRI: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=279 FHIR observation in US Core lab observation profile: https://build.fhir.org/ig/HL7/US-Core/Struct |
Use Case Description |
LRI: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=279
FHIR observation in US Core lab observation profile: https://build.fhir.org/ig/HL7/US-Core/StructureDefinition-us-core-observation-lab.html (observation.interpretation; though it is not currently a MUST SUPPORT element)
In IHE XD-Lab (and C-CDA) it is observation.interpretation: https://art-decor.ihe-europe.net/art-decor/decor-templates--XDLAB-?section=templates&id=1.3.6.1.4.1.19376.1.3.1.6&effectiveDate=2008-08-08T00:00:00&language=en-US - the entire template applies to the observation with reference range, interpretation etc. |
Estimate the breadth of applicability of the use case(s) for this data element
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This is applies to all laboratory tests, so LIS, EHR-s, HIEs, PHR, surveillance systems, decision support systems, disease registries. |
Healthcare Aims |
- Improving patient experience of care (quality and/or satisfaction)
- Improving the health of populations
- Reducing the cost of care
- Improving provider experience of care
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Maturity of Use and Technical Specifications for Data Element |
Applicable Standard(s) |
HL7 interpretation code system and value set - this is one of the few code systems that has been harmonized acros ALL HL7 product families (v2, CDA and FHIR)
https://terminology.hl7.org/CodeSystem-v3-ObservationInterpretation.html
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Additional Specifications |
N/A |
Current Use |
This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders |
Supporting Artifacts |
I assume this is in wide use to support physician alerting and it is a CLIA requriement, so should be part of pretty much every lab report
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Extent of exchange
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5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders. |
Potential Challenges |
Restrictions on Standardization (e.g. proprietary code) |
addition to the code system must be done through HL7 terminology processes |
Restrictions on Use (e.g. licensing, user fees) |
HL7 licensing |
Privacy and Security Concerns |
none |
Estimate of Overall Burden |
should already be implemented |
Submitted by Riki Merrick on
Support for HL7 observationInterpretation
APHL supports the comment by CAP (https://www.healthit.gov/isa/comment/13160) highlighting that the HL7 observationInterpretation code system (https://terminology.hl7.org/CodeSystem-v3-ObservationInterpretation.html) should be the required vocabulary used; this code system is used in ALL HL7 products (V2, CDA and FHIR). In addition allowing use of SNOMED CT with values drawn from the qualifier hierarchy is also appropriate and should be supported as optional.