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

Data Element

Additional Information
Result Reference Range
Description
Upper and lower limit of test values expected for a designated population of individuals. Usage note: reference range values may differ by patient characteristics, laboratory test manufacturer and laboratory test performer.
Submitted By: Nedra Y Garrett / CDC
Data Element Information
Use Case Description(s)
Use Case Description Physicians, nurses, epidemiologists, and anyone who is using laboratory reports for patient care, including patients, will depend on the reference range for the correct interpretation of the provided laboratory results. It must be available to the authorized person who ordered the test and, if applicable, the individual responsible for using the test results.
Estimated number of stakeholders capturing, accessing using or exchanging Level 2 - Element pertain to most or all patients, providers or requestors.
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) The Unified Code for Units of Measure (UCUM)
https://ucum.org/ucum.html \
Additional Specifications https://hl7.org/fhir/us/core/StructureDefinition-us-core-observation-clinical-test-definitions.html#Observation.referenceRange
Current Use Extensively used in production environments
Supporting Artifacts Level 2
Reference Range is exchanged extensively in the current production environment in all electronic exchanges of laboratory test results as it is part of CLIA regulations. It is mapped to UCUM as a standard when the reference range is expressed in numerical units. In some cases, the reference range is complicated and may not be simply expressed in just upper and lower limits.
US Core Observation Clinical Test Result FHIR Profile has included Reference Range as an optional element. See link #1 below.
In the US Core Implementation Guide JSON representation example in link #2, this element is also expressed in UCUM.
For Laboratory Results Interface (LRI), the applicable data type is String.

http://hl7.org/fhir/R4/observation.html#Observation.referenceRange; https://hl7.org/fhir/us/core/Observation-blood-glucose.json.html;
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.
Supporting Artifacts Level 2
“Reference Range” is a CLIA requirement under 42 CFR 493.1291(d).
Because it is a regulatory requirement, all numerical test results include this data element. Hence it is used extensively in the production environment.

https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/subject-group-ECFR9482366886d579f/section-493.1291#p-493.1291(d)
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) No restriction.
Restrictions on Use (e.g. licensing, user fees) No restriction.
Privacy and Security Concerns No concerns
Estimate of Overall Burden Very low burden. This element should already be part of the EHR due to its laboratory regulatory requirement (CLIA)
Other Implementation Challenges None
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 2 - Used at scale in more than 2 different production environments
Maturity - Current Exchange Level 2 - Demonstrates exchange between 4 or more organizations with different EHR/HIT systems
Breadth of Applicability - # Stakeholders Impacted Level 2 - Used by a majority of patients, providers or events requiring its use
Evaluation Comment This data element aligns with CLIA requirements to report the reference range of the test performed.

It has been tested at scale and is supported in HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm

Comment

Submitted by jkegerize on 2023-04-17

ACLA Comment on Laboratory: Result Reference Range

The American Clinical Laboratory Association (ACLA) comment pertains to the Applicable Standard(s): The Unified Code for Units of Measure (UCUM) and the estimate of overall burden: Very low burden.  ACLA Comments: Using only the UCUM as a standard is problematic and the burden would be very high using this standard. The UCUM cannot be used when it is not supported by the analytic procedure’s documentation for an FDA authorized, cleared, or approved method. Existing interfaces should not be required to update to the UCUM. (Note: the FDA approved units must be used for reporting, regardless of the standard used).     

Submitted by jkegerize on 2023-04-17

ACLA Comment on Laboratory: Result Reference Range

The American Clinical Laboratory Association (ACLA) comment pertains to the Applicable Standard(s): The Unified Code for Units of Measure (UCUM) and the estimate of overall burden: Very low burden.  ACLA Comments: Using only the UCUM as a standard is problematic and the burden would be very high using this standard. The UCUM cannot be used when it is not supported by the analytic procedure’s documentation for an FDA authorized, cleared, or approved method. Existing interfaces should not be required to update to the UCUM. (Note: the FDA approved units must be used for reporting, regardless of the standard used).     

Submitted by hantran on 2023-04-17

CAP Comment on Result Reference Range

  • Data Class: Laboratory
  • Data Element: Result Reference Range
  • CAP Comment: The CAP applauds the ONC’s decision to add this data element to USCDI v4, as this data element represents the upper and lower limit of test values expected for a designated population of individuals and is required by CLIA. However, the CAP would like to note that a simple text field for this data element (as in HL7 2.5.1) is inadequate for interoperability. The CAP recommends that this Result Reference Range data element be aligned with the FHIR observation.referenceRange element, which supports discrete low and high values, normalValue (expected value), and text based reference descriptions. For this data element, the CAP recommends UCUM for units and SNOMED CT for non-numerical values.

Submitted by hswmin on 2023-04-14

THIA Comment on Laboratory: Result Reference Range

The Texas Health Informatics Alliance (THIA) Policy and Standards Working Group supports the proposal for result reference range; however, we are cognizant of the fact that the reference range may change depending on an individual’s ethnic or gender make-up. Many reference ranges are based on young, healthy males. Consequently, reference ranges can be problematic due to (lack of) representation of different demographics like sex, age, gender, ethnicity. Notably, there are issues with how reference ranges are developed between institutions; however, it would take a lot of work to re-establish all reference ranges. It might be helpful to have a warning note based on heritage and/or some language to raise the issue of reference ranges not being focused on the pertinent population. Further exploration of the best way to present these nuances is needed and the proposal should consider requirements on establishing complete representation of the population being served.

Submitted by nedragarrett_CDC on 2023-04-07

CDC's Consolidated Comment for USCDI v4

  • Physicians, nurses, epidemiologists, and anyone who is using laboratory reports for patient care and public health, including patients, will depend on the reference range for the correct interpretation of the provided laboratory results. It must be available to the authorized person who ordered the test and, if applicable, the individual responsible for using the test results. It is required by CLIA for all laboratory reports, 493.1291(d) Standard: Test report. Link: https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/subject-group-ECFR9482366886d579f/section-493.1291
  • Comments from NACCHO: NACCHO supports including the data element reference range. Most local health departments (LHD) do not have laboratory expertise, so having the reference range on a test is critical. While joining the reference range based on a LOINC code is possible, most LHDs do not have the license to LOINC, nor the expertise needed to associate the reference range. In addition, laboratory custom tests offered by commercial labs do not have a standardized reference range and must be provided.
  • Comments from CSTE: CSTE agrees with CDC's recommendation for this data element.

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