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

Data Element

Information from the submission form
Test Result Harmonization Status
Description

Harmonization status indicates equivalency of results across platforms and vendors, ie, a harmonized test for a particular analyte and specimen yield results equivalent to other harmonized tests for that analyte and specimen. Harmonization is required for full clinical interoperability of test results. Results from harmonized tests may be interpreted and trended together, and may use the same calculation and decision support rules. Machine learning models may be trained and applied to data sets from different test platforms and vendors if the tests are harmonized. Tests that are not harmonized do not yield comparable results and should be interpreted and processed separately, not in aggregate with other tests. Incorrect assumption of harmonization status is a serious patient safety risk, and lack of harmonization information impedes public health interpretation of test results.

Submitted By: Han Tran / College of American Pathologists (CAP)
Data Element Information
Use Case Description(s)
Use Case Description Reference Range:
This data element aligns with CLIA’s Reference Range reporting requirement. The CLIA requirements are required for laboratory reporting and should be used as the basis for laboratory and public health reporting standards. The primary use cases for this data element in the USCDI are routine communication of laboratory results to healthcare providers and public health agencies in support of test result interpretation. These use cases are similar to existing use cases for OBX-7 that are described in detail in the following documentation.
 HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)
 HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=98)
 HL7 Version 2.5.1 Implementation Guide: Orders and Observations; Interoperable Laboratory Result Reporting to EHR, Release 1 (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=94).

Name and Address of Laboratory Location:
This data element aligns with CLIA’s requirement to report the name and address of the laboratory location where the test was performed. The CLIA-defined requirements are required for laboratory reporting and should be used as the basis for laboratory and public health reporting standards. The main use case is routine communication of laboratory results to healthcare providers and public health agencies in support of test result interpretation.

Condition and Disposition of Specimens:
This data element aligns align with CLIA’s requirement to report any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. The CLIA-defined requirements are required for laboratory reporting and should be used as the basis for laboratory and public health reporting standards. The main use case is routine communication of laboratory results to healthcare providers and public health agencies in support of test result interpretation.

Test Result Harmonization Status:
The primary use case for harmonization status is in sharing data for clinical interpretation and use. If a test result from an external site has a harmonization status matching local tests, the harmonized results could be displayed in the same line of a flow sheet, and trended and processed with local results. A non-harmonized result would not be clinically compatible with local results and should be displayed and processed separately. In a public health setting, harmonized results could be grouped for surveillance processing, statistical analysis, and machine learning applications. Non-harmonized results should be kept separate.
Estimated number of stakeholders capturing, accessing using or exchanging Reference Range:
The data element would be used with all laboratory result messages sent between laboratories and data recipients including public health agencies, and in messages sent between provider organizations that contained laboratory results. Since there are around 330,000 CLIA-certified laboratories in the United States that are information sources, the usage floor including laboratories and their communication partners would be substantially above that number.

Name and Address of Laboratory Location:
The data element would be used with all laboratory result messages sent between laboratories and data recipients including public health agencies, and in messages sent between provider organizations that contained laboratory results. Since there are around 330,000 CLIA-certified laboratories in the United States that are information sources, the usage floor including laboratories and their communication partners would be substantially above that number.

Condition and Disposition of Specimens:
The data element would be used with all laboratory result messages sent between laboratories and data recipients including public health agencies, and in messages sent between provider organizations that contained laboratory results. Since there are around 330,000 CLIA-certified laboratories in the United States, there is a usage floor of approximately 660,000 organizations assuming each laboratory sends data to at least one other organization.

Test Result Harmonization Status:
Because the data element would be needed to meet any current or future clinical interoperability requirements, the CAP anticipates that it would become a routine component of laboratory result reporting. Since there are around 330,000 CLIA-certified laboratories in the United States that are information sources, the usage floor including laboratories and their communication partners would be substantially above that number.
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) These proposed elements are a work in progress and the CAP urges that the vocabulary standards listed be considered for a future version of USCDI:

Reference Range:
The CAP proposes that the content of this data element follow the OBX-7 field from the HL7 2.5.1 standard. The CAP supports the use of the HL7 2.5.1 standard because the standard was designed to help laboratories comply with CLIA requirements. For numerical values, the CAP also proposes the Unified Code for Units of Measure (UCUM) standard. The CAP supports the use of the UCUM standard because it is well-established and because a common standard for units of measure will reduce errors related to translation of units of measure from one system to another.

Name and Address of Laboratory Location:
In lieu of a non-standard and inefficient textual description of a name and address, the CAP is proposing the use of the CLIA identification number as the data element content. All laboratories performing clinical testing have a CLIA identification number and are required to be able to report it, so the use of this number is not burdensome. The name and location of a laboratory can be determined quickly from the CLIA number using available online resources (for example, https://www.cdc.gov/clia/LabSearch.html).

Condition & Disposition of Specimens:
The CAP proposes the use of SNOMED CT for data element content. SNOMED CT is a relatively complete, well-curated, and actively-managed medical ontology that has excellent coverage of concepts appropriate for description of laboratory specimens, specimen sources, and conditions, and supports a rich array of hierarchical and other concept relationships.

Test Result Harmonization Status:
This is the first proposal of a harmonization status data element, and examples do not exist in other health data standards. Recently the ISO defined standard methods for harmonizing laboratory tests (see ISO 17511:2020 and 21151:2020). The CAP proposes development of a standard representation of these methods as content for this data element.
Additional Specifications Reference Range:
 HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)
 HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=98)
 HL7 Version 2.5.1 Implementation Guide: Orders and Observations; Interoperable Laboratory Result Reporting to EHR, Release 1 (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=94).

Name and Address of Laboratory Location:
 Data elements representing laboratory identity are included in the following HL7 2.5.1 Implementation Guides.
 HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)
 HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=98)
 HL7 Version 2.5.1 Implementation Guide: Orders and Observations; Interoperable Laboratory Result Reporting to EHR, Release 1 (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=94).

Condition & Disposition of Specimens:
 Analogous data elements are discussed in the HL7 v. 2.5.1 documentation, see below. HL7 uses two fields to carry this information, SPM-21 and SPM-24. The contents of these fields are HL7 code sets, with extensions allowed. The CAP is proposing similar concepts but using SNOMED CT for data representation.
 HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)
 HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=98)
 HL7 Version 2.5.1 Implementation Guide: Orders and Observations; Interoperable Laboratory Result Reporting to EHR, Release 1 (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=94).

Test Result Harmonization Status:
To our knowledge, this is the first proposal of a data element to represent result harmonization.
Current Use This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
Supporting Artifacts Reference Range:
HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)

Name and Address of Laboratory Location:
HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)

Condition & Disposition of Specimens:
Note that the usage has been with the two HL7 fields and the HL7 value sets, which are strongly analogous to but not identical with what is proposed here.
 Supporting Artifact: HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279), see SPM-21 and SPM-24.

Test Result Harmonization Status:
Not currently captured or accessed.
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279
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 Reference Range:
HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)

Name and Address of Laboratory Location:
HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279)

Condition & Disposition of Specimens:
The data elements have been tested at scale (“5 or more…”) but not in exactly the form proposed. For analogous HL7 data elements, see HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface, Release 1 STU Release 3 - US Realm (https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279).

Test Result Harmonization Status:
No.
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=279
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) Reference Range:
None

Name and Address of Laboratory Location:
None

Condition and Disposition of Specimens:
None

Test Result Harmonization Status:
None per se. There could be a dependence on ISO standards, which are proprietary, depending on how that information is used.
Restrictions on Use (e.g. licensing, user fees) Reference Range:
None

Name and Address of Laboratory Location:
None

Condition and Disposition of Specimens:
None

Test Result Harmonization Status:
None
Privacy and Security Concerns Reference Range:
None

Name and Address of Laboratory Location:
None

Condition and Disposition of Specimens:
None

Test Result Harmonization Status:
None
Estimate of Overall Burden Reference Range:
No burden. Laboratories are already required to report this information as part of CLIA.

Name and Address of Laboratory Location:
None

Condition and Disposition of Specimens:
None

Test Result Harmonization Status:
Laboratories would need to define the content of an additional data field when building result messages. The content of the field is likely to be selected a limited number of alternatives and therefore should be of limited additional burden.
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 Comment Level - May be represented by a vocabulary standard or an element of a published technical specification.
Maturity - Current Use Comment Level - Used in limited test environments or pilots
Maturity - Current Exchange Comment Level - Demonstrates limited exchange with external organizations, on same or different EHR/HIT systems
Breadth of Applicability - # Stakeholders Impacted Comment Level - Used by few stakeholders, or for narrowly defined conditions or events
Evaluation Comment
Thank you for your submission. The rationale for adding this to the Comment level is that the data element is not yet collected or accessed, is not included in an exchange standard and is not exchanged.

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