|Submitted By: Riki Merrick / Association of Public Health Laboratories|
|Data Element Information|
|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||This is applies to all laboratory tests, so LIS, EHR-s, HIEs, PHR, surveillance systems, decision support systems, disease registries.
|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=126.96.36.199.4.1.193188.8.131.52.6&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||This is applies to all laboratory tests, so LIS, EHR-s, HIEs, PHR, surveillance systems, decision support systems, disease registries.|
|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)
|Current Use||This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders|
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
|Extent of exchange||5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.|
|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|