| Submitted By: Nedra Y Garrett / CDC | |
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| 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 |
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| 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 |
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| 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 |
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