Analysis of clinical specimens to obtain information about the health of a patient.

Data Element

Information from the submission form
Test Interpretation (Abnormal Flag)
Description
This data element was adopted into Draft USCDI v4 under the new data element name Result Interpretation. A categorical assessment of an observation value, often in relation to its clinical context (e.g., high, low, critical high).
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.
Estimated number of stakeholders capturing, accessing using or exchanging 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.
Estimated number of stakeholders capturing, accessing using or exchanging 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
Number of organizations/individuals with which this data element has been electronically exchanged 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 4 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
Maturity – Standards/Technical Specifications Level 1/2 - Must be represented by a vocabulary standard or an element of a published technical specification
Maturity - Current Use Level 1 - Used in limited production environments, 1 or 2 different systems
Maturity - Current Exchange Level 1 - Demonstrates exchange between 2 or 3 organizations with different EHR/HIT systems
Breadth of Applicability - # Stakeholders Impacted Level 1 - Used by many, but not most, patients, providers or events requiring its use

Comment

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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