Data Element
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=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 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
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
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
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.
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
ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 1 - Data element is captured, stored, or accessed in at least one production EHR or HIT module.
Criterion #3
Maturity - Current Exchange		 Level 1 - Data element is electronically exchanged between two production EHRs or other HIT modules using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 1 - Use cases apply to several care settings or specialties.

Comment

Submitted by Riki Merrick on 2023-09-20

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.

Submitted by hantran on 2023-04-17

CAP Comment on Result Interpretation

  • Data Class: Laboratory
  • Data Element: Result Interpretation
  • CAP Comment: The CAP applauds the ONC’s decision to add this data element to USCDI v4, as this data element represents the categorical assessment of a laboratory value (e.g. “high”, “low”, “critical”, etc.) and is required by CLIA. The CAP recommends that the HL7 interpretation code system and value set—which was in the original submission for this data element—be added as a minimum vocabulary standard for this data element. The CAP would also recommend that the ONC include SNOMED CT as a vocabulary standard for this element.

Submitted by hswmin on 2023-04-14

THIA Comment on Laboratory: Result Interpretation

The Texas Health Informatics Alliance (THIA) Policy and Standards Working Group supports the proposal for result interpretation; however, standardization of high, low, critical, and normal values should be explored and standardized by CAP and APHL. The definition of a critical value per institution should be kept in mind when the data is collected and there should be some level of consistency between institutions. It is important to consider the cut-off for a critical value between various facilities. This is especially true for interpreting lab results. Every lab has to establish their own reference ranges relative to their population and instrumentation. It might be problematic or unclear how far out of the normal various labs are and if there are different levels for different institutions. Additionally, an expansive number and type of assays are performed; it is unrealistic to assume that providers know and/or are comfortable with interpreting all of them. It is important to provide interpretations. Notably, there is a push for making data available to patients. Patients can read results before their clinicians get to them. In Epic MyChart, there is a little red eye to indicate that the clinician has not seen the results yet. However, it is unlikely that all systems have a similar feature. The requirement of a similar feature may encourage compliance.

Submitted by Riki Merrick on 2022-09-30

APHL Comments on ISA 2022

APHL still supports inclusion of this data element in the Laboratory class of USCDI V4. - see also https://www.healthit.gov/isa/comment/4711 - which applies to this data element as a specialization of observation interpretation.

Submitted by hantran on 2022-09-30

CAP Comment on Test Interpretation (Abnormal Flag) Data Element

Data Element: Test Interpretation (Abnormal Flag)
  • Corresponding CLIA Reporting Requirement: Test result interpretation
  • Description: The College of American Pathologists (CAP) supports this data element as written and urges that it be brought up to Level 2 and ideally included in USCDI v4. The CAP supports this data element to align with CLIA’s test result interpretation reporting requirement. The CLIA-defined reporting requirements are required for laboratory reporting and should be used as the basis for laboratory and public health reporting standards. Because laboratories already communicate test result interpretations along with reference ranges to the Centers for Medicare & Medicaid Services (CMS), this data element is already in wide usage and should be classified Level 2 at a minimum.

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